1.1 GORD,
ULCERS, IRRITABLE BOWEL
1.1 GORD, ULCERS, IRRITABLE BOWEL
ALIMENTARY SYSTEM
2MO
H2 blocker. Nizatidine 150mg. Pale/dark yellow ACIDEX Pinewood cap. coded 3144. 30, A12.95. S Duodenal and benign gastric ulcer. 2O Prevention of duodenal ulcer recurrence. Reflux suppressant/antacid. Na+ alginate 500mg, P 300mg in the evening for four or if + ++ Na bicarbonate 267mg, Ca carbonate 160mg/ necessary eight weeks. Alternatively, 150mg 10ml. Susp. 200ml, A2.93; 500ml, A3.82. morning and evening. Prophylaxis, 150mg in the S Gastric reflux, oesophagitis, hiatus evening for up to 1 year. hernia, heartburn incl. heartburn of pregnancy, Q Not recommended. similar gastric disorders. B Impaired renal or hepatic function. P 10-20ml after meals and at night. Pregnancy, lactation. Q Under 6 years, not recommended. 6-12 years, 5-10ml after meals and at bedtime. Over 12 A Urticaria, somnolence, sweating, raised liver enzymes, hepatitis, jaundice, years, same as adult. thrombocytopenic purpura. Hypersensitivity B Na+ restricted diet. reactions. A Constipation, flatulence, stomach cramps, belching.
BISODOL
ALUDROX
Ocean
McNeil Healthcare 2 K
2O Antacid. Alum. (hydrox.). Gel. 200ml, A1.56; 500ml, A2.19. S Hyperacidity, peptic ulceration, dyspepsia. P 5-10ml four times daily between meals and at bedtime. Q Infants, not recommended; others, in proportion to dosage for 70kg adult. D Hypophosphataemia.
Antacid. Heavy mag. carb. 18mg, light mag. carb. 345mg, Na+ bicarb. 532mg per 5ml. Powder. 50g, A1.91; 100g, A2.97. S Relief of indigestion, dyspepsia, heartburn, acidity and flatulence. P 1 x 5ml spoonful in water after meals or as required. Q Not recommended.
2K
ALSO BISODOL TABLETS Sodium bicarb. 64mg, Ca++ carb. 522mg, light mag. carb. 68mg. White tab. 30, A1.45; 100, A3.34. ANDREWS ANTACID TABLETS GSK P 2 as required. Q Not recommended. 2K B Renal impairment. Antacid. Ca++ carb. 600mg, Mg++ carb. 125mg. C Tetracyclines, iron salts, vits. and digoxin White tab. 30, A1.38. (take 2 hrs. apart). S Stomach upsets due to hyperacidity and heartburn. BUSCOPAN Boehringer Ing.
2K
ALSO ANDREWS FRUIT FLAVOUR Ca++ carb. 600mg, Mg++ carb. 125mg. Lemon tab. 30, A1.60; 60, A3.05. P 1-2 as required. Max. 12 in 24 hours. Q Under 12 years, not recommended. C Caution: Tetracyclines.
2MO Anticholinergic. Hyoscine butylbromide 10mg. White sug-ctd tab. 56, A3.03. S Spasm of GI and genito-urinary tract. P 2 four times daily. Q Under 6 years, not recommended. 6-12 years, 1 three times daily.
Treatment and prophylaxis of NSAID-associated benign gastric/duodenal ulcers. ZES. Benign peptic lesions, including reflux oesophagitis (RO), unresponsive to H2 receptor antagonists. Eradication and prevention of H. pylori associated ulcers in combination with appropriate antibiotic therapy. P GORD: 30mg once daily, for 4 weeks; double duration if not fully healed. Long term management: 15-30mg once daily. Duodenal/ benign gastric ulcer: 30mg once daily; duodenal ulcers, 4 weeks; gastric ulcers, 8 weeks. NSAIDassociated ulcers: 15-30mg once daily for 4 or 8 weeks; if not fully healed a further 4 weeks treatment can be given. Longer course or higher dose may be used if severe or in at risk patients. Prophylaxis of NSAID-associated ulcers: 15mg or 30mg once daily. ZES: Initially 60mg once daily. Individually adjust and continue as long as necessary. Eradication of Hp: 30mg twice daily for 1 week in combination with appropriate antibiotic therapy, see SPC. If daily dose q 120mg admin. in 2 divided doses. Swallow cap. whole, before food. Severe hepatic impairment: 15-30mg. Max. 30mg daily. R 15-30mg. Max. 30mg daily. Q Not recommended. D Pregnancy, lactation (no data). B Exclude possibility of malignant gastric tumour. Severe hepatic dysfunction. Risk of GI infections. Treatment q 1 year: Unless considered essential; if visual disturbances occur consult ophthalmologist. Contains sucrose. C Avoid: Ketoconazole, itraconazole. Caution: Oral contraceptives, phenytoin, carbamazepine, theophylline, warfarin, CYP2C19 and CYP3A4 inhibitors, drugs with a narrow therapeutic index. Tacrolimus (monitor). Antacids and sucralfate (take 1 hr apart). A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue.
BYSEC
Helsinn Birex
2MO
PPI. Omeprazole 10mg, 20mg. Yellow and white or white resp. gastro-resistant cap. marked 10mg or 20mg. 10mg-28, A8.44; 20mg-28, A13.41. ANTEPSIN ALSO BUSCOPAN INJECTION Hyoscine S Duodenal ulcer, relapse of reflux 2M butylbromide 20mg/ml. 1ml amp. 10, A2.37. oesophagitis (RO), NSAID related gastric and Cytoprotectant. Sucralfate 1g. White oblong S Acute spasm, as in renal or biliary colic; duodenal ulcers (treatment and prevention in scored tab. marked ANTEPSIN one side, WY/39 on in radiology for differential diagnosis of patients with history). Benign gastric ulcers, reverse. 50, A7.16. obstruction and to reduce spasm and pain in Zollinger-Ellison syndrome (ZES). The eradication 2M pyelography and in other diagnostic procedures of H. pylori associated peptic ulcers in combination ALSO ANTEPSIN SUSPENSION Sucralfate 1g/5ml. where spasm may be a problem, e.g. gastrowith appropriate antibacterial therapeutic Susp. 250ml, A7.16. duodenal endoscopy. regimens. S Duodenal and gastric ulcer, chronic P 20mg IM or IV repeated after half an P Swallow cap. whole with sufficient gastritis. Prophylaxis of GI haemorrhage from hour if required. fluid. RO: 20mg once daily for 4-8 weeks. stress ulceration in seriously ill patients. Q Not recommended. Maintenance: 10mg-20mg once daily. Duodenal P 2-4g twice daily on rising and at D Myasthenia gravis, megacolon, narrow ulcers: 20mg once daily for 2-4 weeks. bedtime. Alternatively 1-2g four times daily taken angle glaucoma. Maintenance: 10mg once daily. Benign gastric 1 hour before meals. Max. daily dose 8g. B Tachycardia, cardiac insufficiency or ulcers: 20mg once daily for 4-8 weeks. All 3 Prophylaxis in stress ulceration, 1g six times daily. failure, cardiac surgery, intestinal or urinary outlet conditions, increase to 40mg once daily if Tabs. may be dispersed in water. obstruction, pyrexia. Pregnancy (only if benefit necessary. ZES: Initially, 60mg once daily. Adjust Q Not recommended. outweighs risk), lactation. individually. Above 80mg daily should be divided B Pregnancy, lactation. Renal dysfunction. C Caution: TCAs, antihistamines, and given twice daily. No time limit. NSAID quinidine, amantadine, phenothiazines, Separate admin. from any drug if bio-availability related gastric and duodenal ulcers: 20mg daily for butyrophenones and disopyramide, dopamine critical. 4-8 weeks. Maintenance: 20mg daily. Hp antagonists, b-adrenergic agents. C Tetracyclines, phenytoin, cimetidine, Eradication: 20mg with amoxicillin 1000mg, digoxin. clarithromycin 500mg, or 20mg with BYLANS Ergha A Constipation, diarrhoea, nausea, gastric clarithromycin 250mg, metronidazole 400-500mg; discomfort, indigestion, dry mouth, rash, pruritus, 2 M O all twice daily for 1 week. Impaired hepatic back pain, dizziness, sleeplessness, vertigo, function: Max. 20mg daily. PPI. Lansoprazole 15mg, 30mg. Cap. with white drowsiness. Q Over 2 years, severe RO only. 10-20kg: cap marked L and white body marked with 15 or 10mg/day; over 20kg: 20mg/day. Duration for 4-8 30 resp. 15mg-28, A6.95; 30mg-28, A13.61. AXID Clonmel S GORD. Duodenal/benign gastric ulcer. weeks; max.12 weeks. Under 2 years, not
2NO Chugai
2
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM recommended. B Exclude possibility of malignancy. Confirm RO endoscopically. Risk of GI infections. Severe hepatic dysfunction (monitor liver enzymes). Combination treatment, caution patients with renal/hepatic dysfunction. Treatment q 1 year: Review regularly. Severely ill patients, monitor visual/auditory senses. Contains sucrose. Pregnancy, lactation (only if benefit outweighs risk). Driving or using machines. C Contra: St. John’s wort, atazanavir, clarithromycin in patients with hepatic impairment. Warfarin, phenytoin, ciclosporin (monitor). Ketoconazole, itraconazole, benzodiazepines (e.g. diazepam, triazolam, flurazepam), digoxin, vitamin B12. A Somnolence, insomnia, vertigo, headache, GI disorders.
GORD,
ULCERS, IRRITABLE BOWEL
B See section 8.1. C Contra: Ergot vasoconstrictors, cisapride, pimozide and terfenadine; substrates of CYP3A4 (unless clearly indicated). Caution: Astemizole and other macrolides, quinidine, disopyramid, drugs with potential to prolong QT, cyclosporin, tacrolimus, sirolimus, digoxin, theophylline, warfarin, zidovudine, inducers / strong inhibitors of CYP3A4. HMG Co-A reductase inhibitors. A Oral monilia, headache, smell alteration, GI disorders. Elevated BUN.
1.1
Pregnancy unless considered essential.
GAVISCON
Reckitt Benckiser
2K Reflux suppressant. Na+ alginate 250mg, Na+ hydrogen carbonate 133.5mg, Ca+ carbonate 80mg. Off-white chewable tabs. 2 flavours (peppermint and lemon). 16-A2.37; 32-A3.96.
2KO
ALSO GAVISCON ADVANCE Na+ alginate 1000mg, K+ bicarb. 200mg per 10ml. Sugar-free, aniseed A COLOFAC Solvay flavour liquid. 500ml, 7.12. S Gastro-oesophageal reflux such as acid 2MO regurgitation, heartburn and indigestion. Antispasmodic. Mebeverine (HCl) 135mg. White P 2-4 tabs. after meals and at bedtime. sug-ctd tab. 100, A9.68. Q Under 12 years, not recommended. S Management of Irritable Bowel 2KO Syndrome ALSO GAVISCON ADVANCE TABLETS Na+ alginate P 1 tab. three times daily 20 mins. before 500mg, K+ bicarb. 100mg. Cream, circular tab. with CIMELDINE Clonmel meals. peppermint flavour, marked with sword and circle 2MO Q Over 10 years, as for adults. Under 10 on one side and GA 500 on reverse. 60, A4.05. H2 blocker. Cimetidine 200mg, 400mg and 800mg. years, not recommended. P 5-10ml or 1-2 tabs after meal or at Pale green film-ctd tab. coded 274, oblong filmCOLPERMIN McNeil Healthcare bedtime. ctd tab. coded 275 and oval film-ctd tab. coded Q Under 12 years, not generally 276 resp. All marked with logo one side. 200mg2K recommended, except on medical advice. 120, A11.04; 400mg-60, A10.51; 800mg-30, Antispasmodic-carminative. Peppermint oil 0.2ml. 2K A11.04. In sust.-release matrix in light blue/dark blue entALSO GAVISCON ADVANCE ORAL SUSPENSION S Benign ulceration of oesophagus, ctd cap. with blue band. 20, A4.91; 100, A13.76. Na+ alginate 100mg, K+ hydrogen carb. 20mg per stomach upper intestinal tract (incl. post-operative S Relief of symptoms of irritable bowel 1ml. Off-white viscous susp. in sachets. 20, A5.30. stomal area) and the Zollinger-Ellison syndrome, syndrome. conditions benefitting from reduced gastric acid P 1 or 2 three times daily 30 mins. before P One to two 5ml measuring spoons after meals and at bedtime excretion. Long term maintenance of benign meals for up to 3 months. Q Over 12 years: As per adults. Under 12 peptic ulcer disease under regular surveillance. Q Not recommended. years: On medical advice. P Duodenal ulcer, 400mg twice daily or D Hypersensitivity to menthol. 2K 800mg at bedtime for min. four weeks; B Capsules should not be broken or ALSO GAVISCON LIQUID GAVISCON LIQUID maintenance, 400mg at bedtime or twice daily. chewed. Other indications, see SPC. C Do not take antacids at the same time. PEPPERMINT Na+ alginate 500mg, Na+ hydrogen carbonate 267mg, Ca+ carbonate 160mg. Oral Q Over 2 years, 25-30mg/kg body weight A Heartburn, skin rash, headache. suspension. 2 flavours (peppermint and aniseed). daily in divided doses. CYTOTEC Pharmacia 300ml-A4.53, 600ml-A6.05. B Exclude malignant disease before and P 10-20 ml after meals and before during treatment. Impaired renal function. 2NO retiring. Monitor patients on long term therapy. Prostaglandin analogue. Misoprostol 200mcg. Q Under 12 years, not recommended. Pregnancy, lactation. Patients with a history of White/off-white hexagonal tab. marked SEARLE 2KO peptic ulcer, particularly the elderly, being treated 1461. 60, A15.96; 112, A29.78. with NSAIDs should be observed regularly. ALSO GAVISCON SUSPENSION Na+ alginate S Treatment of duodenal, gastric and C Oral anticoagulants, phenytoin, 500mg, Na+ bicarb. 267mg, Ca++ carb. 160mg/ NSAID-induced ulceration. Prophylaxis of NSAIDtheophylline. 10ml. Pink, oral suspension. 500ml, A3.27. induced ulceration. A Diarrhoea, dizziness, rash, tiredness. P 10-20ml after meals and at night. P 4 daily in two or four divided doses Gynaecomastia, occasional reversible liver damage, with meals and at bedtime for 4-8 weeks. Q Half adult dose. confusion. Leucopenia, incl. agranulocytosis, 2OY Prophylaxis, one, two, three or four times daily pancytopenia, aplastic anaemia, sinus bradycardia, during NSAID use. ALSO GAVISCON INFANT Alginic acid 225mg, tachycardia, heart block, anaphylaxis, Q Not recommended. mag. alginate 87.5mg per dose Powder. 15 dual hypersensitivity, masculitis, alopecia. Very rarely D Pregnancy. Women planning pregnancy. sachets (30 doses), A3.03. interstitial nephritis with occasional increase in Lactation. Allergy to prostaglandins. S Helps to prevent gastric regurgitation in plasma creatinine, acute pancreatitis, B Cerebrovascular, coronary artery or infants where competence of the cardiac sphincter thrombocytopenia, headache, myalgia, arthralgia. severe peripheral vascular disease. Pre-menopausal has not been fully established. The indications for women should use contraception. use are gastric regurgitation, gastro-oesophageal CLOROM Rowex A Diarrhoea, abdominal pain, GI upset, reflux and reflux associated with hiatus hernia in menstrual problems, vaginal bleeding, rash, 2NO infants and young children. dizziness. Macrolide. Clarithromycin 250mg, 500mg. White, Q Breast fed infants: under 4.5kg 1 dose; oblong, convex, film-ctd tab. scored on both faces. over 4.5kg 2 doses. Add 5ml boiled cooled water FYBOGEL MEBEVERINE A A 250mg-14, 10.75; 500mg-14, 18.20. to powder, mix, add further 10ml water, give Reckitt Benckiser after each feed. Bottle fed infants: under 4.5kg 1 S Eradication of H. pylori (Hp) in patients 2OY with Hp associated ulcers in combination with dose in 115ml feed; over 4.5kg 2 doses in 225ml appropriate antibacterial and ulcer healing agents. Antispasmodic/bulking agent. Mebeverine (HCl) feed. Young children, 2 doses prepared as for P 500mg twice daily in combination with 135mg, ispaghula husk 3.5g. Orange flavoured breast fed infants, to be taken after each meal. A A amoxicillin 1000mg twice daily and omeprazole D Gaviscon Infant: Diarrhoea, excessive efferves. grans. Sachets-10, 2.92; 60, 17.54. 20mg twice daily during 7 days. water loss, renal impairment. S Irritable bowel syndrome. Q 12 years and under with weight Q P 1 sachet morning and evening in water B Highly restricted salt diet (contains K+ and Na+); hypercalcaemia, nephrocalcinosis, renal 30kg, not suitable. 30 mins. before meals. An additional sachet may calculi (contains Ca++). Renal insufficiency. Tabs. D Severe hepatic/renal impairment. be taken before the midday meal. contain aspartame. Advance oral suspension Hypokalemic patients (risk of prolongation of QT- Q Not recommended. time). Hypersensitivity to other macrolides, D Intestinal obstruction and colonic atony. contains methyl hydroxybenzoate and propyl Severe renal or cardiovascular conditions. hydroxybenzoate. lincosamide and azalide antibacterial agents. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
3
1.1 GORD,
ULCERS, IRRITABLE BOWEL
GERTAC
Gerard
ALIMENTARY SYSTEM
KLACID FORTE
Abbott Caution: CYP2C19 and CYP3A4 inhibitors and
2MO
2NO
H2 blocker. Ranitidine (HCl) 150mg white-beige film-ctd tab. marked G one side and 00/30 on reverse. 300mg white-beige cap.-shaped film-ctd tab. marked G one side and 0031 on reverse. 150mg-60, A22.41; 300mg-30, A20.67. S Treatment of duodenal and gastric ulcer; prophylaxis of duodenal ulcer, reflux oesophagitis (RO). Treatment of Zollinger-Ellison’s syndrome (ZES). P Duodenal and gastric ulcer, 150mg twice daily or 300mg at bedtime. For duodenal ulcer dosage may be increased to 300mg twice daily for up to 4 weeks. Prophylaxis of duodenal ulcer, 150mg at bedtime. RO, 300mg daily or 150mg twice daily for 4-8 weeks or if necessary up to 12 weeks. ZES, see SPC. Q Not recommended. B Exclude malignant disease before treatment. Impaired renal function. Pregnancy, lactation. A Headache, dizziness. Rarely hepatitis, thrombocytopenia, leucopenia, hypersensitivity, confusion, breast symptoms.
Macrolide. Clarithromycin 500mg. Yellow oval film-ctd tab. marked with logo. 14, A12.13. S Eradication of H. pylori in patients with duodenal ulcer, in conjunction with anti-secretory agent. P Triple therapy vs H. pylori, 500mg twice daily with amoxycillin 1g twice daily and a PPI (at the approved daily dose) for 7-10 days. Dual therapy vs H. pylori eradication, 500mg three times daily for 14 days with an acid suppressant. Q Not recommended. B Renal or hepatic impairment. Pregnancy, lactation. C Theophylline, oral anticoagulants, carbamazepine, digoxin, terfenadine, drugs metabolised by P450. A Nausea, vomiting, abdominal pain and diarrhoea, headache, rash. Transient CNS effects.
substrates (e.g. theophylline, carbamazepine). Digoxin, tacrolimus, phenytoin, warfarin. Antacids and sucralfate (take 1 hr apart). A GI disorders, eczema, urticaria, itching, rash, headache, dizziness, fatigue.
LANZOL
Rowex
2MO
PPI. Lansoprazole 15mg, 30mg. Opaque, yellow and white gelatine caps. resp. 15mg-28, A12.42; 30mg-7, A6.17; 30mg-28, A24.68. S Duodenal and gastric ulcer. Reflux oesophagitis (RO), long-term prophylaxis of RO. Eradication of H. pylori (Hp) in combination with antibiotic therapy and prevention of relapse. Zollinger-Ellison syndrome (ZES). NSAID-associated benign gastric and duodenal ulcers (maintenance and treatment). GORD. P Ulcers and RO: 30mg once daily swallowed whole with liquid into empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 LANZIOP Teva weeks; double duration if not fully healed. NSAID2MO associated ulcers: 30mg once daily for 4 or 8 PPI. Lansoprazole 15mg, 30mg. White/redweeks; longer course or higher dose may be used brownish and white gel caps., resp. 15mg-28, if severe. Prophylaxis of RO and NSAID-associated A13.60; 30mg-28, A27.12. ulcers: 15mg once daily; may be increased up to IMOGAS McNeil Healthcare S Duodenal and gastric ulcer. Reflux 30mg daily. Eradication of Hp: 30mg twice daily in 2K oesophagitis (RO), long-term prophylaxis of RO. combination with recommended antibiotics. ZES: Deflatulent. Simeticone 240mg. Egg-shaped Zollinger-Ellison syndrome (ZES). Initially 60mg once daily. Individually adjust and transparent soft cap. 10, A2.55. P Ulcers and RO: 30mg once daily continue as long as necessary. Max. 180mg, if daily S Symptomatic treatment of abdominal swallowed whole with liquid into empty stomach; dose q 120mg admin. in 2 divided doses. GORD: distension (flatulence) in adults from the age of duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 15-30mg once daily for up to 4 weeks. If 15 years. weeks; double duration if not fully healed. symptoms persist after 4 weeks on 30mg further P 1 cap. at the end of each main meal Prophylaxis of RO: 15mg once daily; may be examination recommended. Impaired renal with a glass of water. Duration: Restricted to 10 increased up to 30mg daily. ZES: Initially 60mg function/ mildly impaired hepatic function: Max. days. once daily. Individually adjust and continue as 30mg daily. Moderately impaired hepatic function: B If symptoms persist or worsen, or long as necessary. Max. 180mg, if daily dose q Max. 15mg daily. prolonged constipation occurs, patient should seek 120mg admin. in 2 divided doses. Impaired renal R 15-30mg. Max. 30mg daily. medical advice. Not recommended for infant colic. function/ mildly impaired hepatic function: Max. Q Not recommended. A Nausea, constipation, hypersensitivity 30mg daily. Moderately impaired hepatic function: D Severely impaired hepatic function. reactions. Max. 15mg daily. Pregnancy, lactation (no data). R 15-30mg. Max. 30mg daily. B Exclude possibility of malignant gastric INFACOL Ocean Q Not recommended. tumour. Caution: Hepatic dysfunction. Risk of GI 2 D Severely impaired hepatic function. infections. Treatment q 1 year: Review regularly, Deflatulent. Activated dimethicone (as Pregnancy, lactation (no data). if visual disturbances occur consult simethicone) 40mg/ml. Emulsion. 50ml, A2.96. B Exclude possibility of malignant gastric ophthalmologist. Contains sucrose. Driving or S Relief of griping pain, colic or wind for tumour. Caution: Hepatic dysfunction. Risk of GI using machines. swallowed air. infections. Treatment q 1 year: Review regularly, C Avoid: Ketoconazole, itraconazole. P Not applicable. if visual disturbances occur consult Caution: CYP2C19 inhibitors, CYP3A4 inhibitors Q Infants, 20mg (0.5ml) before each feed ophthalmologist. Gastro-duodenal ulcers, consider and substrates, digoxin, tacrolimus, phenytoin, increasing to 40mg (1ml) if necessary. A H. pylori infection as an etiological factor. warfarin. Antacids and sucralfate (take one hour progressive improvement in symptoms may occur Contains sucrose. Driving/using machines. apart). over several days. C Avoid: Ketoconazole, itraconazole. A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue.
LANZOPRAZOLE BENTLEY
MIMS Ireland current policy for drug inclusion The current editorial policy in MIMS Ireland is to include only medicines with Product Authorisations (PA number) or unlicensed products that are GMS reimbursed. Consequently, all products that do not belong to either of these categories are not listed in the present publication. This decision has been taken in order to preserve conciseness and consistency of MIMS Ireland. 4
Bentley
2MO PPI. Lansoprazole 15mg, 30mg. White opaque caps marked L on cap and strength on body, with gastro-resistant micropellets. 15mg-28, A9.90; 30mg-28, A19.67. S Duodenal/benign gastric ulcers, reflux oesophagitis (RO, maintenance and treatment), gastrooesophageal reflux disease (GORD), NSAID related gastric/duodenal ulcers (maintenance and treatment), Zollinger-Ellison syndrome (ZES). In combination with antibacterial regimens for eradication of H. pylori (Hp) associated peptic ulcers. P Admin. all treatments once daily in the morning, except Hp eradication (twice daily morning and evening). Swallow whole with liquid at least 30 mins before food. Ulcers: 30mg daily;
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM duodenal, 2 weeks; gastric, 4 weeks. RO: 30mg daily for 4 weeks. Maintenance, 15mg daily as necessary. For ulcers and RO, double duration if not fully healed. GORD: 15 or 30mg daily, up to 4 weeks. NSAID-related ulcers: 30mg daily for 4 weeks or 8 weeks if not fully healed (consider longer course or higher dose if severe or in at risk patients). Prophylaxis: 15mg daily; increase to 30mg daily if fails. ZES: Initially 60mg daily. Individually adjust up to 180mg and continue as long as necessary. Doses q120mg daily should be divided in two. Eradication of Hp: 30mg twice daily for 7 days in combination with one of the following: Clarithromycin 250-500mg twice daily and amoxicillin 1g twice daily or clarithromycin 250mg twice daily and metronidazole 400-500mg twice daily. Moderate or severe hepatic impairment: Use half dose. R Max. 30mg daily. Q Not recommended. B Exclude possibility of malignant gastric tumour. Teatment q1 year (assess risk/benefit). Contains sucrose. Pregnancy, lactation (not recommended). C Contra: Atazanavir. Avoid ketoconazole, itraconazole. Caution: Digoxin, CYP3A4 substrates, theophylline, tacrolimus, fluvoxamine, CYP2C19 and CYP3A4 inducers (e.g. rifampicin, St John’s wort), antacids, sucralfate (1 hr apart). A Headache, dizziness, GI disorders, rash, urticaria, itching, fatigue. Increase in liver enzyme levels.
GORD,
ULCERS, IRRITABLE BOWEL
1.1
cyclosporin, clarithromycin, ketoconazole or itraconazole, digoxin, vit. B12. A Drowsiness, somnolence, sleep disturbances, vertigo and headaches, GI disorders.
PPI. Omeprazole 10mg, 20mg, 40mg. Light pink, pink and red-brown tabs resp. All oblong, film-ctd marked with tab. strength and containing ent-ctd pellets. Dispersible in water. 10mg-28, A8.74; 20mg-28, A16.45; 40mg-14, A16.43. LOSAMEL Clonmel S Treatment of oesophageal reflux (OR) disease, incl. reflux oesophagitis (RO). Treatment 2MO PPI. Omeprazole 20mg. Light grey gastro-resistant of duodenal and benign gastric ulcers. Healing and prophylaxis of NSAID-associated benign A tab. (tabs. must not be broken). 30, 28.12. gastric ulcers and duodenal ulcers. H. pylori S Treatment of duodenal ulcer, benign gastric ulcers, reflux oesophagitis, Zollinger-Ellison eradication in peptic ulcer disease. Relief of syndrome, treatment of NSAID-related gastric and associated dyspeptic symptoms. Prophylaxis of acid aspiration. Zollinger-Ellison syndrome (ZES). duodenal ulcers, gastro-oesophageal reflux P OR: 20mg once daily for 4 weeks. In disease, in combination with appropriate those unhealed after initial course, healing usually antibacterial therapeutic regimens for the eradication of Helicobacter pylori in patients with occurs during a further 4-8 weeks treatment. Refractory RO, 40mg daily for 8 weeks. H. pylori associated peptic ulcers. Maintenance of severe RO, 20mg daily increasing P Duodenal ulcer: 20mg once daily; to 40mg once daily if relapse. Acid reflux disease: healing usually occurs within 2-4 weeks. Benign Long term management, 10mg once daily, gastric ulcers and RO: 20mg once daily; healing increasing to 20mg if symptoms return. Duodenal usually occurs within 4-8 weeks. Maintenance and gastric ulcer: 20mg daily usually for 4-8 treatment of reflux oesophagitis: 10-20mg daily. Zollinger-Ellison syndrome: See SmPC. NSAID weeks. Increase to 40mg once daily if severe. ulceration: 20mg once daily; healing usually occurs Maintenance, 10mg once daily increasing to 20mg within 4-8 weeks; maintenance 20mg once daily. once daily if symptoms return. NSAID ulceration: Gastro-oesophageal reflux disease: 10-20mg daily. For healing and prophylaxis 20mg once daily. Hp Healing usually occurs within 2-4 weeks. H. pylori eradication: Triple therapy, Losec 20mg with eradication regimens in peptic ulcer disease: 20mg clarithromycin 250mg and metronidazole 400mg twice daily in association with the following or amoxycillin 1g and clarithromycin 500mg all regimens amoxicillin 1000mg and clarithromycin twice a day for 1 week. Dual therapy, Losec 20mg 500mg both twice daily for one week or with oral amoxycillin 1g both twice daily for 2 clarithromycin 250mg and metronidazole 400weeks. Alternatively, Losec 40mg once daily with 500mg both twice daily for one week. Tabs. clarithromycin 500mg three times daily for 2 LOPRAZ Teva should be swallowed whole before a meal. weeks. Acid aspiration: 40mg on evening before 2MO Q Severe RO resistant to other therapeutic surgery followed by 40mg 2- 6 hrs prior to PPI. Omeprazole 10mg, 20mg, 40mg. Opaque measures: 10mg (10-20 kg) or 20mg (q20 kg) once surgery. ZES: Initially 60mg, adjusting at 20-120mg yellow caps. containing gastro-resistant granules. daily. daily. Doses above 80mg, twice daily. 10mg-28, A13.10; 20mg-28, A24.61; 40mg-14, B Avoid use during pregnancy and Q Treatment of refractory RO, 10mg (10A24.65. lactation. Severe liver disease. In gastric ulcer 20kg) or 20mg (q20kg) once daily for 4-12 weeks. S Duodenal ulcer, benign gastric ulcers, exclude malignancy before treatment. With 2N reflux oesophagitis (RO, maintenance and prolonged treatment, patients should be reviewed ALSO LOSEC INFUSION Omeprazole 40mg (as treatment), GORD, Zollinger-Ellison syndrome periodically by a consultant. omeprazole Na+ 42.6mg). Powder in vial. 40mg-5, (ZES), NSAID related gastric and duodenal ulcers C Diazepam, phenytoin, warfarin, A43.48. (maintenance and treatment). In combination with ketoconazole, itraconazole, digoxin, P Where oral medication inappropriate, antibacterial regimens for eradication of H. pylori clarithromycin, roxithromycin, erythromycin, 40mg once daily as IV inf. over 20-30 mins. Acid associated peptic ulcers. hexabarbital, citalopram, imipramine, aspiration: 40mg as IV inf. one hour before P Swallow tab. whole with sufficient fluid clomipramine, disulfiram, cyclosporin, vitamin B12. surgery. Only reconstitute powder in 100ml saline before meal. Duodenal ulcers: 20mg once daily A Headache, vertigo, drowsiness, sleep or 100ml dextrose (5%) for inf. during 2-4 weeks. Gastric ulcers: 20mg daily during disturbances, GI upset, paraesthesia, changes in Q Not recommended. 4-(6)-8 weeks. RO: 20mg daily during 4-8 weeks; liver function, hypersensitivity (skin rash). B Pregnancy and lactation. Severe liver maintenance, 10-20mg daily. All three conditions, Leucopenia and thrombocytopenia have been disease. In gastric ulcer exclude malignancy before increase to 40mg once daily if necessary. GORD: reported. treatment. With prolonged treatment, review 10-20mg daily during 2-4 weeks. ZES: Initially, patients periodically. 60mg daily. Adjust individually. Above 80mg daily, LOSEC MUPS AstraZeneca C Contra: Atazanavir. Ketoconazole, admin. in two divided doses. No time limit. NSAID 2MO itraconazole, clarithromycin, tacrolimus. diazepam, related gastric and duodenal ulcers: 20mg daily during 4-8 weeks. Maintenance: 20mg daily. CHANGE OF ADDRESS Eradication: 20mg with amoxicillin 1000mg and clarithromycin 500mg, or 20mg with Doctors are requested to notify the publisher clarithromycin 250mg and metronidazole 400immediately of any change of address.Write to: 500mg, all 2 times daily during 1 week. Impaired hepatic function: Max. 20mg daily. Q Over 2 years, severe RO only. 10-20kg: Circulation Department, 10mg/day; over 20kg: 20mg/day. Duration: 4-8 MIMS Ireland weeks; max.12 weeks. Under 2 years, not 24-26 Upper Ormond Quay, recommended. B Exclude possibility of malignancy. Renal Dublin 7. dysfunction, severe hepatic impairment (monitor liver function). Long-term treatment. Contains or fax: (01) 8176365 sucrose. Pregnancy, lactation (only if benefit or e-mail: subscribe@mims.ie outweighs risk). C Clarithromycin (do not use if hepatic giving new address, old address and, if possible label from impairment), St. John’s wort (avoid). Caution: Diazepam, some other benzodiazepines, warfarin, a previously posted issue. phenytoin, other CYP2C substrates, disulfiram, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
5
1.1 GORD,
ULCERS, IRRITABLE BOWEL
phenytoin, warfarin and other vitamin K antagonists. A Headache, GI upset.
ALIMENTARY SYSTEM
2
ALSO MAALOX PLUS TABLETS Alum. hydrox. 200mg, mag. hydrox. 200mg, simethicone 25mg. Yellow/white tab. marked MAALOX on one side LOSEPINE Pinewood and RORER on reverse. 20, A2.84; 50, A5.25. S Heartburn, indigestion, flatulence and 2MO dysepsia. PPI. Omeprazole 10mg, 20mg. Oval red-brown P 1-2 tabs. four times a day (after meals gastro-resistant tab. 10mg-28, A14.50; 20mg-28, and at bedtime) or as required. A27.38. Q Not recommended. S Duodenal ulcer, benign gastric ulcers, reflux oesophagitis (maintenance and treatment), D Severely debilitated patients. Kidney GORD, Zollinger-Ellison syndrome (ZES), history of failure. Pregnancy (unless essential). ulcer following use of anti-inflammatory products, B Advance renal disease, low phosphate diet e.g. malnutrition. NSAID related gastric and duodenal ulcers (maintenance and treatment). In combination with C Caution: Tetracyclines, digoxin and vitamins. antibacterial regimens for eradication of H.pylori associated peptic ulcers. Amdipharm P Swallow tab. whole with sufficient fluid MAXOLON before meal or on empty stomach. Duodenal 2MO ulcers: 20mg once daily during 2-4 weeks. Antidopaminergic. Metoclopramide Maintenance: 10mg daily. Gastric ulcers: 20mg monohydrochlor. 10mg. White to off-white scored daily during 4-(6)-8 weeks. RO: 20mg daily during tab. marked MAXOLON. 84, A6.36. 4-8 weeks. Maintenance: 10-20mg daily. All three 2MO conditions, increase to 40mg once daily if ALSO MAXOLON SYRUP Metoclopramide (HCl) necessary. GORD: 10-20mg daily during 2-4 weeks. 5mg/5ml. 100ml, A1.60; 200ml, A3.20. ZES: Initially, 60mg daily. Adjust individually. 2NO Above 80mg daily, admin. in two divided doses. ALSO MAXOLON INJECTION Metoclopramide No time limit. NSAID related gastric and duodenal (HCl) 5mg/2ml. Amp 12 x 5mg, A3.46. ulcers: 20mg daily during 4-8 weeks. Maintenance: S Adults over 20 years: Disorders of the GI 20mg daily. Eradication: 20mg with amoxicillin tract associated with delayed gastric emptying 1000mg and clarithromycin 500mg, or 20mg with (e.g. reflux oesophagitis, hiatus hernia, postclarithromycin 250mg and metronidazole 400vagotomy syndrome). Diagnostic procedures (e.g. 500mg, all 2 times daily during 1 week. Impaired barium studies and duodenal intubations). To hepatic function: Max. 20mg daily. counteract gastric stasis associated with attacks of Q Over 2 years, severe RO only. 10-20kg: migraine and assist absorption of orally 10mg/day; over 20kg: 20mg/day. Duration: 4-8 administered analgesics for that condition. Under weeks; max.12 weeks. Under 2 years, not 20 years: As an aid to GI intubation. recommended. P 10mg three times daily. Q60kg, see B Exclude possibility of malignancy. below. Diagnostic indications: Single 10-20mg Increased risk of GI infections. Hepatic dysfunction dose, 5-10 min before examination. (monitor transaminase levels). Contains lactose. Q Medical indications: 15-19 years q60kg, Pregnancy, lactation. 10mg three times daily; 30-59kg, 5mg three times C Caution: Ketoconazole or itraconazole, daily; 9-14 years r30kg, 5mg three times daily; 5diazepam, R-warfarin and phenytoin, digoxin, 9 years 20-29kg, 2.5mg three times daily; 3-5 years erythromycin and roxitromycin. 15-19kg, 2mg two to three times daily; 1-3 year A Dizziness, somnolence, insomnia, 10-14kg, 1mg two to three times daily; Q1year vertigo, sense of malaise and headache, GI Q10kg, 1mg twice daily. Diagnostic indications: 5disorders. 10 min before examination. 15-19 years, 10mg; 9-
faintly cream circular biconvex film-ctd tabs. 10, 20, A6.43.
A3.67;
2K ALSO MOTILIUM FASTMELTS Domperidone 10mg. White or off-white circular orodispersible tab. 10, A3.99; 20, A7.00. S Post-prandial symptoms of fullness, nausea, epigastric bloating and belching occasionally accompanied by epigastric discomfort and heartburn. P Up to 10mg 3 times daily and at night for 2 weeks max. Q Under 16 years, not recommended. Over 16 years, as per adults. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. Hepatic and/or renal impairment. Pregnancy, lactation. B Contains aspartame. C Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin). A Raised serum prolactin.
MOTILIUM RX
McNeil Healthcare
2OY Antidopaminergic. Domperidone 10mg. White film-ctd tab. marked M/10 on one side and JANSSEN on reverse. 100, A 6.04. S Disorders of GI tract associated with delayed gastric emptying and oesophageal reflux. P 10mg orally, 3 times daily, 15-30 mins before meals and if necessary before retiring. Q Under 1 year, under specialist supervision.
2MO ALSO MOTILIUM SUSPENSION Domperidone 1mg per ml. Oral susp. 200ml, A2.08. S Epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents in adults. P 10ml-20ml 3-4 times per day before meals. Max. 80ml. Reevaluate after 4 weeks.
2MO
ALSO MOTILIUM SUPPOSITORIES Domperidone 10mg, 30mg, 60mg. 10mg-6, A1.80; 30mg-6, A1.81; 60mg-6, A7.31. S Epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric 14 years, 5mg; 5-9 years, 2.5mg; 3-5 years, 2mg; contents in adults. MAALOX sanofi-aventis Q3 years, 1mg. P 1 (60mg) suppos. twice daily. Reevaluate 2O D Phaeochromocytoma. Epilepsy. GI after 4 weeks. Antacid. Alum. hydrox. gel 225mg, mag. hydrox. haemorrhage, mechanical obstruction or D Pregnancy (unless essential), lactation. 200mg/5ml. Susp. 500ml, A5.00. perforation. Pregnancy, lactation (unless essential). Patients with prolactin releasing pituitary tumours, GI haemorrhage, mechanical obstruction or S Dyspepsia. perforation. Hepatic impairment. P 5-10ml (1-2 spoonfuls) taken 20-60 mins. B Not for use in the immediate postB Severe renal insufficiency, especially if after meals and at night. operative period (up to 3-4 days) following 2 pyloroplasty or gut anastomosis. Assess risk/benefit: prolonged use. C Anticholinergics, CYP3A4 inhibitors, Significant hepatic or renal impairment, ALSO MAALOX NO. 2 TABLETS Dried alum. antacids or antisecretory agents, phenothiazines or Parkinson’s disease. If vomiting persists, reassess hydrox. gel 400mg, mag. hydrox. 400mg. White other neuroleptics, dopaminergic agonists. patient to exclude underlying disorder (e.g. tab. marked WHR both sides with odour of A Raised serum prolactin. cerebral irritation). Caution: History of atopy peppermint. 40, A3.45. (including asthma) or porphyria. May occur: S Dyspepsia. NEXIUM AstraZeneca P 1-2 four times daily chewed 20-60 mins. Neuroleptic malignant syndrome, elevation of serum prolactin levels. Rare hereditary problems of 2 M O after meals and at bedtime. Max. 8 in 24 hrs. not galactose intolerance, Lapp lactose deficiency of more than 2 weeks unless indicated by physician. PPI. Esomeprazole (magnesium trihydrate) 20mg, glucose-galactose malabsorption. Q Not recommended. 40mg. Pink oblong film-ctd tabs. marked 20mg or C Anticholinergics, phenothiazines, CNS 2 40mg one side and symbol on reverse. 20mg-28, drugs (MAOIs, sympathomimetics), serotonergic A26.72; 40mg-28, A41.23. ALSO MAALOX PLUS SUSP Alum. hydrox. gel drugs, alcohol. 225mg, mag. hydrox. 200mg, simethicone 25mg/ S Treatment of erosive reflux oesophagitis A Extrapyramidal reactions. A 5ml. Susp. 355ml, 5.00. (RO); long-term management of patients with healed oesophagitis to prevent relapse; S Heartburn, indigestion, flatulence and MOTILIUM McNeil Healthcare symptomatic treatment of gastroesophageal reflux dysepsia. 2K disease (GORD). Healing of H. pylori (Hp) P 1-2 x 5ml spoonfuls four times a day Antidopaminergic. Domperidone 10mg. White to associated duodenal ulcer. Prevention of Hp (after meals and at bedtime) or as required.
6
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
1.1 GORD,
ULCERS, IRRITABLE BOWEL
associated peptic ulcer relapse. Patients requiring continued NSAID therapy: Healing of gastric ulcers associated with NSAID therapy, and prevention of gastric and duodenal ulcers associated with NSAID therapy in at risk patients. Treatment of Zollinger Ellison Syndrome (ZES). Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers. P Erosive RO: Treatment, 40mg once daily for 4 weeks; additional 4 weeks for patients not healed. Prevention of relapse, 20mg once daily. GORD without oesophagitis: 20mg once daily until symptom resolution; maintenance 20mg once daily when required. In adults, an on demand regimen taking 20mg once daily, when needed, can be used. Healing/ prevention of Hp associated ulcers: 20mg with 1g amoxycillin and 500mg clarithromycin, all twice daily for 7 days. NSAID induced ulcers: Treatment, 20mg once daily for 4-8 weeks; prevention, 20mg once daily. ZES: 40mg twice daily. Usual range 80-160mg daily. Doses q 80mg daily, divide and admin. twice-daily. After IV induced prevention of rebleeding of peptic ulcers: 40 mg once daily for 4 weeks. Severe renal impairment: Max. 20mg once daily. Q Over 12 years, RO and GORD only, as per adults. Under 12 years, not recommended.
2JM ALSO NEXIUM I.V. 40MG Esomeprazole (sodium) 42.5mg (equiv. esomeprazole 40mg). Powder in vial for soln. for inj. or inf. 40mg-1, A7.98. S GORD in patients with esophagitis and/ or severe symptoms of reflux as an alternative to oral therapy. Healing of gastric ulcers associated with NSAID therapy. Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. P IV inj. over 3 mins. or IV inf. over 1030mins. RO: 40mg once daily. Symptomatic treatment for reflux disease/healing and prevention of NSAID-associated ulcers: All 20mg once daily. Transfer to oral as soon as possible. Prevention of rebleeding after endoscopy: 80mg as bolus inf. over 30 min, followed by IV inf. of 8mg/h over 72 hrs, then by oral acid-suppression therapy. Severe liver impairment: GORD, max. 20mg daily; rebleeding prevention, 4mg/h for 71.5 hours may be sufficient. Q Not recommended. D Hypersensitivity to other substituted benzimidazoles. Lactation. B In gastric ulcer exclude malignancy before treatment. Long term treatment (monitor). Severe hepatic/renal insuffiency. Slightly increased risk of GI infections (Salmonella, Campylobacter). Pregnancy. Contains lactose. C Contra: Nelfinavir. Not recommended: Atazanavir. Caution: Ketoconazole, itraconazole, CYP2C19 substrates (diazepam, phenytoin, citalopram, imipramine, clomipramine), warfarin or other coumarine derivatives, cisapride. A Headache, GI disorders.
ALIMENTARY SYSTEM
(ZES), NSAID related gastric and duodenal ulcers (maintenance and treatment). In combination with antibacterial regimens for eradication of H. pylori associated peptic ulcers. P Swallow tab. whole with sufficient fluid before meal. Duodenal ulcers: 20mg once daily during 2-4 weeks. Gastric ulcers: 20mg daily during 4-(6)-8 weeks. RO: 20mg daily during 4-8 weeks; maintenance, 10-20mg daily. All three conditions, increase to 40mg once daily if necessary. GORD: 10-20mg daily during 2-4 weeks. ZES: Initially, 60mg daily. Adjust individually. Above 80mg daily, admin. in two divided doses. No time limit. NSAID related ulcers: 20mg daily during 4-8 weeks. Maintenance: 20mg daily. Eradication: 20mg with amoxicillin 1000mg and clarithromycin 500mg, or 20mg with clarithromycin 250mg and metronidazole 400-500mg, all 2 times daily during 1 week. Impaired hepatic function: Max. 20mg daily. Q Over 2 years, severe RO only. 10-20kg: 10mg/day; over 20kg: 20mg/day. Duration: 4-8 weeks; max.12 weeks. Under 2 years, not recommended. B Exclude possibility of malignancy. Severe hepatic impairment (monitor liver function). Longterm treatment (q1 year). Contains sucrose. Pregnancy, lactation (only if benefit outweighs risk). C Contra: Atazanavir, clarithromycin (in hepatic impairment). Avoid St. John’s wort, ketoconazole itraconazole. Caution: Diazepam, some other benzodiazepines, warfarin, phenytoin, other CYP2C substrates, disulfiram, cyclosporin, tacrolimus, clarithromycin, digoxin, vit. B12. A Drowsiness, dizziness, somnolence, sleep disturbances, headaches, GI disorders.
500mg twice daily or amoxicillin 1g twice daily + metronidazole 400-500mg twice daily. Gastric/ duodenal ulcers: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control); maintain as long as required. Impaired liver function: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Not recommended. D Severe hepatic insufficiency (combination therapy for H. pylori eradication). For prescribing information, see pantoprazole Drug Presc. Notes. B Contains maltitol.
PANTIUM
2MO
Clonmel
2MO PPI. Pantoprazole 20mg. Yellow oval gastroresistant tab. 20mg-28, A12.27. S Mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily. Control recurrent symptoms with 20mg once daily ondemand regimen if required; if symptoms not controlled adequately consider switch to continuous therapy. RO: 20mg daily; increase to 40mg daily if relapse occurs. Carefully analyse risk/ benefit for treatment q1 year. NSAID-induced ulcers: 20mg daily. Impaired liver function: Max 20mg daily . Q Under 12 years, not recommended. Over 12 years: Mild reflux disease, RO: As per adults.
2MO
ALSO PANTIUM 40MG Pantoprazole 40mg. Yellow oval gastro-resistant tab. 40mg-28, A22.73. S Combination therapy with 2 suitable antibiotics for eradication of H. pylori and prevention of relapse of peptic ulcers in patients OMEPRAZOLE BENTLEY Bentley with H. pylori associated ulcers; duodenal ulcers; 2MO gastric ulcers; moderate or severe forms of RO; PPI. Omeprazole 10mg, 20mg, 40mg. Opaque red/ long-term treatment of Zollinger-Ellison syndrome (ZES) and other disorders accompanied by orange, blue/orange, blue/orange caps. marked pathological gastric acid hypersecretion. O10, O20, O40 resp. containing gastro-resistant P RO: 40mg daily; may be doubled. H. granules. 10mg-28, A11.05; 20mg-28, A17.99; A pylori eradication: 40mg twice daily in 40mg-14, 18.84. combination with either amoxicillin 1g twice daily S Duodenal ulcer, benign gastric ulcers, + clarithromycin 500mg twice daily or reflux oesophagitis (RO, maintenance and clarithromycin 250-500mg + metronidazole 400treatment), GORD, Zollinger-Ellison syndrome
8
PANTOFLUX
Actavis
2MO PPI Pantoprazole 20mg. Elliptical biconvex light yellow gastro-resistant tab. 28, A13.08. S Treatment of mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with a need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO: 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced ulcers: 20mg daily. Severe liver impairment: Max 20mg daily. Q Under 12 years, not recommended. Over 12 years: Mild reflux disease, RO: As per adults. ALSO PANTOFLUX 40MG Pantoprazole 40mg. Elliptical biconvex dark yellow gastro-resistant tab. 28, A24.17. S Symptomatic improvement and healing of GI diseases requiring a reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, Zollinger-Ellison-Syndrome (ZES) and other pathological hypersecretory conditions, eradication of Helicobacter pylori (in combination with antibiotics in patients with duodenal ulcer or gastric ulcer). P RO: 40mg daily. Duodenal/gastric ulcer: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). H. pylori eradication: 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg twice daily or clarithromycin 500mg + metronidazole 500mg twice daily or amoxicillin 1g twice daily + metronidazole 500mg twice daily. Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Under 12 years, not recommended. Over 12 years: RO: As per adults. D Moderate to severe liver or renal insufficiency (40mg tab. in combination therapy to eradicate H. pylori). For prescribing information, see pantoprazole Drug Presc. Notes.
PANTOPRAZOLE NICHE
Niche
2MO PPI. Pantoprazole 20mg. Light brownish yellow, oval, slightly biconvex gastro-resistant tab. 28,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM A11.46.
S Mild reflux disease and associated symptoms. Long-term management and prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 20mg daily. R Max 40mg daily. Q Not recommended.
2MO ALSO PANTOPRAZOLE NICHE 40MG Pantoprazole 40mg. Light brownish yellow, oval, slightly biconvex gastro-resistant tab. 28, A21.22. S Relief of symptoms and short-term treatment of GI diseases which require a reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, eradication of H. pylori in combination with antibiotic therapy in patients with peptic ulcer, Zollinger-Ellison syndrome and other hypersecretory conditions. P Moderate to severe RO/ duodenal/ gastric ulcer: 40mg daily. H. pylori eradication: 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg twice daily or clarithromycin 250-500mg + metronidazole 400-500mg twice daily or amoxicillin 1g twice daily + metronidazole 400500mg twice daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 40mg every other day. R Max 40mg daily except for H.pylori eradication (as per adults for 1 week). Q Not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Contains sorbitol.
GORD,
ULCERS, IRRITABLE BOWEL
prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Severe hepatic impairment: Max 20mg daily. Q Under 12 years, not recommended.
2MO ALSO PANTOPRAZOLE RANBAXY 40MG Pantoprazole 40mg. Yellow enteric-ctd oval shaped, biconvex tab. marked P 40 on one side. 28, A15.14. S Moderate and severe reflux oesophagitis. Duodenal ulcer. Gastric ulcer. Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions. P Moderate to severe RO/ duodenal/ gastric ulcer: 40mg daily; may be doubled. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Max 40mg daily. Severe hepatic impairment: Max 20mg daily or 40mg every other day. Elderly: Max 40mg daily. R Max 40mg daily. Q Under 12 years, not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes.
PANTOPRAZOLE TEVA
Teva
2MO
PPI inhibitor. Pantoprazole 20mg (as Na+ sesquihydrate). Light brownish-yellow, oval, slightly biconvex gastro-resistant tab. 20mg-28, A12.27. S Treatment of mild reflux disease and associated symptoms. Long-term management and prevention of relapse in reflux oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective NSAIDs. P Mild reflux disease: 20mg daily. RO: PANTOPRAZOLE RANBAXY 20mg daily. Increase to 40mg daily if relapse Ranbaxy occurs. NSAID-induced ulcers: 20mg daily. Hepatic 2MO impairment: Max 20mg daily. Q Not recommended. PPI. Pantoprazole 20mg. Yellow enteric-ctd oval 2MO shaped, biconvex tab. marked P 20 on one side. 28, A8.18. ALSO PANTOPRAZOLE TEVA 40MG Pantoprazole 40mg (as Na+ sesquihydrate). Light brownishS Treatment of mild reflux disease and associated symptoms. Long-term management and yellow, oval, slightly biconvex gastro-resistant tab.
1.1
40mg-28, A22.72. S Relief of symptoms and short-term treatment of Gl diseases requiring reduction in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, Zollinger-Ellison Syndrome (ZES) and other hypersecretory conditions. P Duodenal gastric ulcer, moderate and severe RO: 40mg daily. ZES: Initially 80mg daily; doses q80 mg daily, divide dose and give twice daily; may be temporarily increased to q160mg. Hepatic impairment: 40mg every other day. Renal impairment: Max 40mg daily. R Max 40mg daily. Q Not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Contains sorbitol.
PANTUP
Rowex
2MO PPI. Pantoprazole 20mg. Yellow oval ctd tabs. imprinted 20 in black. 20mg-28, A10.82. S Mild reflux disease and associated symptoms; long-term management and prevention of relapse in reflux oesophagitis (RO); prevention of gastroduodenal ulcers induced by non-selective NSAID in patients at risk with need for continuous NSAID treatment. P Mild reflux disease: 20mg daily; control reoccurring symptoms with 20mg once daily ondemand if required; consider switch to continuous therapy if symptoms not controlled adequately. RO: 20mg daily; increase to 40mg daily if relapse occurs. NSAID-induced gastroduodenal ulcers: 20mg daily. Severe hepatic impairment: Max 20mg daily. Q Not recommended.
2MO ALSO PANTUP 40MG Pantoprazole 40mg. Yellow oval ctd tabs. imprinted 40 in black. 40mg-28, A20.04. S Duodenal ulcers; gastric ulcers; moderate or severe RO; Zollinger-Ellison syndrome (ZES) and other disorders involving pathological hypersecretion. P Duodenal /gastric ulcer, RO: 40mg daily; dose may be doubled. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). Impaired renal function: Maximum 40mg. Severe hepatic impairment: Maximum 40mg every other day. R Maximum 40mg daily. Q Not recommended. D Moderate to severe liver or renal insufficiency (40mg tab. in combination with antibiotic therapy). For prescribing information,
Drug Prescribing Notes ● PANTOPRAZOLE Special Precautions Exclude malignancy of gastric ulcer or a malignant disease of the oesophagus prior to treatment ● May reduce the absorption of vitamin B12 ● Severe liver impairment: Monitor liver enzymes regularly, discontinue if levels increase ● Regular surveillance in long term treatment (especially when exceeding a treatment period of 1 year) ● May lead to a slightly increased risk of GI infections, such as Salmonella and Campylobacter ● Patients who do not respond after 4 weeks should be investigated ● Restrict use of 20mg tablets for NSAID induced gastroduodenal ulcers to patients requiring continuous NSAID treatment and at increased risk of GI complications (>65 years, history of gastric or duodenal ulcer, upper GI bleeding). Pregnancy: Clinical experience in pregnant women is limited. In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. Lactation: There is no information on the excretion of pantoprazole into human breast milk. Should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby. Drug Interactions Contraindicated: Atazanavir. Caution: Drugs with pH-dependent bioavailability (e.g. ketoconazole, itraconazole), coumarin anticoagulants (monitor prothrombin time/INR after initiation, termination or during irregular use of pantoprazole). Side-Effects Headache, upper abdominal pain, diarrhoea, constipation, flatulence. Revised November 2009
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
9
1.1 GORD,
ULCERS, IRRITABLE BOWEL
ALIMENTARY SYSTEM
400mg-60, A11.02. S Benign ulceration of oesophagus, stomach, upper intestinal tract (incl. post-operative PARIET Janssen-Cilag stomal area) and the Zollinger-Ellison syndrome. Conditions benefitting from reduced gastric acid 2MO PPI. Rabeprazole (Na+) 10mg, 20mg. Pink tab. and excretion. Long term maintenance of benign peptic ulcer disease under regular surveillance. yellow tab. resp. Both ent-ctd. 10mg-28, A17.58; P Duodenal ulcer, 400mg twice daily or 20mg-28, A27.56. 800mg at bedtime for min. four weeks; S Active duodenal ulcer, active benign maintenance, 400mg at bedtime or twice daily. gastric ulcer and symtomatic erosive or ulcerative Other indications, see SPC. Impaired renal gastro-oesophageal reflux disease (GORD). Long function; Reduce dosage. Daily dosage, do not term maintenance of patients with GORD. exceed 2400mg. Symptomatic treatment of moderate to very Q Over 2 years, 25-30mg/kg body weight severe GORD. Zollinger-Ellison Syndrome (ZES). In daily in divided doses. combination with appropriate antibacterial B Exclude malignant disease before and regimens for the eradication of Helicobacter pylori during treatment. Impaired renal function. in patients with peptic ulcer disease. Monitor patients on long term therapy. P Swallow tab. whole in the morning Caution:Driving/operating machinery, patients at before eating. Active duodenal or benign gastric risk of falling blood cell counts. Contains lactose. ulcer, 20mg once daily for 4-6 weeks. Erosive or Pregnancy, lactation. ulcerative GORD, 20mg once daily for 4-8 weeks. C Oral anticoagulants, phenytoin, Maintenance, 10-20mg once daily. Symptomatic theophylline. GORD, 10mg once daily in patients without oesophagitis; once symptoms resolved, subsequent A Diarrhoea, dizziness, rash, tiredness. control can be achieved by 10mg once daily taken Gynaecomastia, occasional reversible liver damage, when needed. ZES, initially 60mg once a day; may confusional states, mood/behavioural changes, insomnia. Leucopenia. Very rarely interstitial be titrated up to 120mg/day (120mg dose in two divided dose). Eradication of H. Pylori, 20mg twice nephritis with occasional increase in plasma creatinine, acute pancreatitis, thrombocytopenia, daily for 7 days in combination with headache, myalgia, arthralgia. clarithromycin 500mg twice daily and amoxycillin 1g twice daily. PROTIUM Nycomed Q Not recommended. 2MO D Pregnancy, lactation. PPI. Pantoprazole 20mg. Yellow, oval biconvex B Exclude malignancy, severe hepatic film-ctd tab. with P20 in brown ink on one side. impairment, long-term treatment. 28, A8.66. C Caution: Ketoconazole, itraconazole. A Headache, GI upset, Infection, insomnia, S Treatment of mild reflux disease and associated symptoms (e.g. heartburn, acid dizziness, cough, pharyngitis, rhinitis, pain/back regurgitation, pain on swallowing). Long-term pain, asthenia, flu-like syndrome. management and prevention of relapse in reflux PEPCID MSD oesophagitis (RO). Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti2MO H2 blocker. Famotidine 20mg beige film-ctd square inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment. tab. marked MSD 963; 40mg brown film-ctd P Mild reflux disease: 20mg daily; control square tab. marked MSD 964. 20mg-28, A16.24. recurrent symptoms with 20mg once daily onA 40mg-28, 30.85. demand regimen if required; consider switching to S Duodenal and benign gastric ulcers. continuous therapy if symptoms not controlled Prevention of relapse of duodenal ulceration. adequately. RO (long-term, prevention of relapse): Zollinger-Ellison syndrome. Prevention and 20mg daily; increase to 40mg daily if relapse treatment of gastro-oesophageal reflux disease. occurs. NSAID-induced gastroduodenal ulcers: P Benign gastric and duodenal ulcer: 20mg daily. Severe hepatic impairment: Max 20mg 40mg at night for 4-8 weeks. Prophylaxis of daily. duodenal ulcer relapse: 20mg at night. ZollingerQ Under 12 years, not recommended. Ellison syndrome: Initially 20mg every 6 hours, 2MO adjust as necessary; max. 800mg daily. GastroALSO PROTIUM 40MG Pantoprazole 40mg. oesophageal reflux disease: 20mg twice daily for 6-12 weeks; with associated erosion or ulceration, Yellow, oval biconvex enteric-ctd tab. marked P40 on one side. 28, A16.03. 40mg twice daily for 6-12 weeks. S Moderate and severe reflux Q Not recommended. oesophagitis. Duodenal ulcer. Gastric ulcer. D Lactation. Zollinger-Ellison syndrome (ZES) and other B Impaired renal function, gastric pathological hypersecretory conditions. Eradication carcinoma. Pregnancy. of H. pylori, in combination with two antibiotics in A Headache, dizziness, CNS disturbances, patients with duodenal ulcer or gastric ulcer. constipation, diarrhoea, dry mouth, nausea, P Moderate to severe RO: 40mg daily. abdominal discomfort, rash, anorexia, fatigue, Duodenal/gastric ulcer: 40mg daily, may be arthralgia, muscle cramps, liver enzyme doubled. ZES: Initially 80mg daily. Doses q80 mg abnormalities, cholestatic jaundice, anaphylaxis, daily, divide dose and give twice daily. May be angioedema. Rarely toxic epidermal necrolysis, A-V temporarily increased to q160mg (no longer than block. required for adequate acid control). H. pylori eradication: 40mg twice daily in combination with PINAMET Pinewood either amoxicillin 1g twice daily + clarithromycin 2MO 500mg twice daily or clarithromycin 250mg + H2 blocker. Cimetidine 400mg. Pale, green, oblong metronidazole 400mg twice daily. Impaired renal function: Max 40mg daily. Severe hepatic bi-convex film-ctd tabs marked 2Y1 on one side. see pantoprazole Drug Presc. Notes. B Contains Ponceau 4R aluminium lake.
10
impairment: Max 40mg every other day. R Max 40mg daily. Q Under 12 years, not recommended.
2N ALSO PROTIUM IV Pantoprazole 40mg (Na+). Powder in vial. 5, A39.21. S Duodenal ulcer. Gastric ulcer. Moderate and severe RO. ZES and other pathological hypersecretory conditions. P Reconstitute with 10ml saline for admin. by inj.; alternatively mix with 100ml saline or 5% glucose sln, for inf. Switch to tab. as soon as oral therapy possible. Moderate to severe RO/ duodenal/gastric ulcer: 40mg daily. ZES: Initially 80mg daily. Doses q80 mg daily, divide dose and give twice daily. May be temporarily increased to q160mg (no longer than required for adequate acid control). For rapid acid control, 2 x 80mg initially. Severe hepatic impairment: 20mg max. Q Under 18 years, not recommended. B For prescribing information, see pantoprazole Drug Presc. Notes. Use IV only if oral application not appropriate.
RANITIC
Rowex
2MO H2 blocker. Ranitidine (HCl) 150mg, 300mg. Both: White film-ctd tab. scored one side. 300mg: Oblong. 150mg-60, A21.73; 300mg-30, A20.56. S Duodenal ulcer, benign gastric ulcer, reflux oesophagitis (RO), post operative ulcer, Zollinger-Ellison’s syndrome (ZES) and other conditions where reduction of gastric acid is likely to be beneficial. P Duodenal and gastric ulcer: 150mg twice daily or 300mg at bedtime. Duodenal, may be increased to 300mg twice daily for up to 4 weeks. RO: 150mg twice daily or 300mg at bedtime for 8 or if necessary up to 12 weeks; moderate to severe oesophagitis, increase to 150mg 4 times daily or 300mg twice daily. ZES, see SPC. Q Peptic ulcer, 2mg/kg or 4mg/kg twice daily; max. 300mg daily.
2K ALSO RANITIC 75MG Ranitidine (HCl) 75mg. Filmctd tab. 7, A2.85; 14, A4.76; 28, A8.56. S Short term symptomatic relief of acid indigestion and heartburn. P 1 swallowed whole with water. Repeat if symptoms return. Max. 2 tabs. in 24 hrs. If symptoms persist more than 2 weeks consult doctor. Q Under 16 years, not recommended. B Exclude malignant disease before treatment. History of acute porphyria. GI ulcers, severe renal/hepatic impairment, dyspepsia related weight loss, middle aged or older patients with dyspepsia symptoms, patients under regular medical control or taking medication; consult doctor before use. Contains lactose. Pregnancy, lactation. C High doses of sucralfate (take 2 hrs apart). NSAIDs (monitor, especially elderly or if history of peptic ulcer).
RANOPINE
Pinewood
2MO H2 blocker. Ranitidine (HCl) 150mg white to offwhite round film-ctd tab. marked RAN 150; 300mg white to off-white cap. shaped film-ctd tab. marked RAN 300. 150mg-60, A19.50; 300mg-30, A18.48. S Benign gastric and duodenal ulcers.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
1.1 GORD,
ULCERS, IRRITABLE BOWEL
ALIMENTARY SYSTEM
Q Under 8 years, not recommended; 8-12 years, 1 three times daily. D Paralytic ileus. Intestinal obstruction, PPI. Omeprazole 10mg, 20mg, 40mg. Hard gastro- faecal impact, total atony of colon. Pregnancy, resistant cap. containing dull yellowish brown lactation. granules.10mg: light brown marked OME10. 20mg: B Adequate fluid intake should be White, marked OME20. 40mg: White cap, light maintained. brown body, marked OME40. 10mg-28, A12.38; C Anti-hypertensives. 20mg-28, A21.23; 40mg-14, A23.28. A Nausea. S Duodenal ulcers, benign gastric ulcers, reflux oesophagitis (RO, treatment and ULCID Astellas maintenance), symptomatic treatment of 2MO gastrooesophageal reflux disease (GORD), PPI. Omeprazole 20mg. White gelatine cap. Zollinger-Ellison syndrome (ZES), NSAID-related containing white or almost white granules. 7, gastric and duodenal ulcers (treatment and A6.35; 28, A15.22. maintenance), in combination with appropriate S Benign gastric and duodenal ulcer. antibacterial therapeutic regimens to eradicate H. Reflux Oesophagitis (RO), treatment and pylori in patients with H. pylori associated peptic maintenance. NSAID related ulcers, treatment, ulcers. Children q1 year and q10kg: Reflux prophylaxis and maintenance. Zollinger Ellison Oesophagitis, symptomatic treatment of heartburn Syndrome (ZES). Hp eradication in peptic ulcer and acid regurgitation in gastro-oesophageal disease. reflux disease. Children over 4 years: In P Duodenal ulcer: 20mg once daily, combination with antibiotics in treatment of treatment 2-4 weeks. Gastric ulcer: 20mg once duodenal ulcer caused by H. pylori. daily, treatment 4-8 weeks. RO, NSAID related P Duodenal ulcers: 20mg daily for 2-4 ulcers: 20mg once daily, treatment 4-8 weeks; weeks; maintenance, 10mg. Benign gastric ulcers: prophylaxis, maintenance 20mg once daily. ZES: 20mg once daily for 4-8 weeks. RO: 20mg daily for Initially, 60mg once daily; divide dose twice daily RAZOLAGER Gerard 4-8 weeks. 40mg may be used in refractory RO. when above 80mg; no time limit on duration. Hp Maintenance: 10-20mg. ZES: Initially 60mg daily. 2MO eradication: 20mg with amoxicillin 1000mg + Divide doses q80mg in twice daily doses. NSAIDclarithromycin 500mg or 20mg with clarithromycin PPI. Lansoprazole 15mg, 30mg. Opaque, yellow related ulcers: 20mg daily for 4-8 weeks. 250mg + metronidazole 400-500mg; all twice daily and white gel. caps. resp. 15mg-28, A12.85; 30mgMaintenance: 20mg. GORD: 10-20mg daily for 2-4 A for 1 week. Impaired hepatic function: Max. daily 28, 23.35. weeks; if no improvement after 2 weeks, perform dose, 20mg. Take cap. preferably in the morning S Duodenal and gastric ulcer. Reflux further examinations. H. pylori eradication: 20mg before breakfast. oesophagitis (RO), long-term prophylaxis of RO. for 1 week in combination with amoxicillin Q Above 2 years, refractory RO: 10mg (10Eradication of H. pylori (Hp) in combination with 1000mg + clarithromycin 500mg twice daily; 20kg) or 20mg (q20kg) once daily. Use alternative antibiotic therapy and prevention of relapse. alternatively, in combination with clarithromycin product for 10mg dosage. Duration usually 4-8 Zollinger-Ellison syndrome (ZES). NSAID-associated 250mg + metronidazole 400-500mg twice daily. weeks, max. 12 weeks. Under 2 years, not benign gastric and duodenal ulcers (maintenance Impaired hepatic function: 20mg daily max. indicated. and treatment). GORD. Q See SPC. B Peptic ulcer disease (determine H. pylori P Ulcers and RO: 30mg once daily B Peptic ulcer disease: Determine H. pylori status, exclude possibility of malignancy). Confirm swallowed whole with liquid into empty stomach; status if relevant. Exclude malignancy before diagnosis of RO endoscopically. Elderly, hepatic/ duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 treatment. Confirm RO diagnosis endoscopically. renal dysfunction (caution, especially in high doses weeks; double duration if not fully healed. NSAIDMay lead to slightly increased risk of GI infections. and during combination therapy). Severely associated ulcers: 30mg once daily for 4 or 8 Hepatic impairment, check liver enzymes impaired hepatic function (check liver enzyme weeks; longer course or higher dose may be used periodically. NSAID-related ulcers: Restrict values periodically). NSAID-related ulcers (consider if severe or in at risk patients. Prophylaxis of RO treatment to at risk patients; consider stopping stopping intake of causative agent before and NSAID-associated ulcers: 15mg once daily; may NSAID. Long term use q 1year: Review risk/ treatment). Pregnancy, lactation. be increased up to 30mg daily. Eradication of Hp: benefit assessment. Combination treatment, C Diazepam (or other benzodiazepines), 30mg twice daily in combination with caution in patients with renal/hepatic dysfunction. phenytoin, warfarin, hexobarbital, citalopram, recommended antibiotics. ZES: Initially 60mg once Monitor visual and auditory senses in severely ill imipramine, clomipramine, disulfiram, cyclosporin, daily. Individually adjust and continue as long as patients. Pregnancy, lactation. Contains lactose. clarithromycin, roxithromycin, erythromycin, necessary. Max. 180mg, if daily dose q 120mg C Contra: Atazanavir, St John’s wort. ketoconazole, itraconozole, digoxin or vit.B12. admin. in 2 divided doses. GORD: 15-30mg once Caution: CYP2C substrates (e.g. diazepam, A GI disorders, nervous system disorders daily for up to 4 weeks. If symptoms persist after 4 triazolam, flurazepam, phenytoin, warfarin, (drowsiness, somnolence, sleep disturbances, weeks on 30mg further examination hexabarbital, citalopram imipramine, vertigo, headaches). recommended. Impaired renal function/ mildly clomipramine), disulfiram, ciclosporin (monitor impaired hepatic function: Max. 30mg daily. plasma levels), clarithromycin, ketoconazole, ZANTAC GSK Moderately impaired hepatic function: Max. 15mg itraconazole, digoxin, vitamin B12. daily. 2MO A Somnolence, sleep disturbances R 15-30mg. Max. 30mg daily. H2 blocker. Ranitidine (HCl) 150mg, 300mg. White (insomnia), vertigo, headaches, drowsiness, GI Q Not recommended. round or capsule-shaped film-ctd tab. marked disorders. D Severely impaired hepatic function. GXE2 or GXEC3 resp. 150mg-60, A13.45; 300mgPregnancy, lactation (no data). SPASMONAL FORTE Norgine 30, A12.41. B Exclude possibility of malignant gastric 2MO 2MO tumour. Caution: Hepatic dysfunction. Risk of GI ALSO ZANTAC EFFERVESCENT Ranitidine (HCl) Antispasmodic. Alverine citrate 120mg. Grey/blue infections. Treatment q 1 year: Review regularly, 150mg. White to pale yellow tab. 2 x 15, A18.78. cap. marked SP120. 60, A15.41. if visual disturbances occur consult 2MO S Irritable bowel syndrome. Painful ophthalmologist. Contains sucrose. ALSO ZANTAC SYRUP Ranitidine (HCl) 150mg/ diverticular disease of the colon. C Avoid: Ketoconazole, itraconazole. 10ml, ethanol 7.5%. Sugar-free syrup. 300ml, P One, 1-3 times daily. Caution: CYP2C19 and CYP3A4 inhibitors and A26.36. Q Not recommended. substrates (e.g. theophylline, carbamazepine). 2 M O 2N Digoxin, tacrolimus, phenytoin, warfarin. Antacids ALSO SPASMONAL Alverine citrate 60mg blue/ ALSO ZANTAC INJECTION Ranitidine (HCl) 50mg/ and sucralfate (take 1 hr apart). grey cap. marked SP60. 100, A12.84. 2ml. Amp. 5, A4.38. A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue. P 1-2 one to three times daily. S Duodenal, benign gastric and postPost-operative ulcer. Zollinger-Ellison syndrome, reflux oesophagitis and other conditions where reduction in gastric acid secretion is likely to be beneficial. P Duodenal and gastric ulcer: 150mg twice daily in the morning and evening or as a single bedtime dose of 300mg for 4-8 weeks. RO: 150mg twice daily or 300mg at bedtime for up to 8 weeks, extended to a max. of 12 weeks if necessary. Moderate to severe oesophagitis, 150mg four times daily up to max. 12 weeks. Other conditions, see SPC. Q Peptic ulcer, 2-4mg/kg twice daily. Max. daily dose 300mg in divided doses. B Exclude malignancy disease before and during treatment, impaired renal function. Monitor patients taking NSAIDs concomitantly, the elderly and those with a history of peptic ulcer. History of acute intermittent porphyria, avoid. Pregnancy, lactation. A Headache, dizziness, mental confusion, blood dyscrasias, skin rash and musculo-skeletal symptoms. Hepatitis, breast symptoms. Rarely hypersensitivity reactions, bradycardia and AV block. Transient changes in the results of liver function tests, acute pancreatitis.
12
ROMEP
Rowex
2MO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM operative ulceration. Reflux oesophagitis, Zollinger-Ellison syndrome, prophylaxis of NSAID associated duodenal ulcer, other conditions where reduction of gastric acid is beneficial. P Duodenal and gastric ulcer: 150mg twice daily or 300mg at bedtime for four to eight weeks; maintenance, 150mg at bedtime. Prophylaxis of NSAID associated duodenal ulcer: 150mg twice daily. Other conditions, see SPC. Q Treatment of peptic ulcer disease 2mg/ kg or 4mg/kg twice daily; max. 300mg daily. B Exclude malignant disease before treatment. Impaired renal function. Pregnancy, lactation. A Headache, dizziness. Rarely hepatitis, thrombocytopenia, leucopenia, hypersensitivity, confusion, breast symptoms.
GORD,
ULCERS, IRRITABLE BOWEL
PPI. Lansoprazole 15mg, 30mg. Opaque, hard gastro-resistant caps.15mg, yellow; 30mg, white. 15mg-28, A10.59; 30mg-28, A19.17. S Healing of confirmed duodenal and gastric ulcer. Treatment and prophylaxis of reflux oesophagitis (RO). Treatment and prophylaxis of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAIDtreatment. Eradication of H. pylori (Hp) in combination with antibiotics and prevention of relapse. Zollinger-Ellison Syndrome (ZES). Symptomatic gastro-oesophageal reflux disease (GORD). P Ulcers and RO: 30mg once daily on empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 weeks; double duration if not fully healed. NSAID-related ulcers: 30mg once daily for 4 or 8 weeks; use longer course or higher dose ZOLEPANT Pinewood if required. Prophylaxis of RO and NSAID-related ulcers: 15mg once daily; may be increased up to 2MO 30mg daily. Eradication of Hp: 30mg twice daily PPI. Pantoprazole 20mg. Light brownish yellow, with antibiotics. ZES: Initially 60mg once daily; oval, slightly biconvex tab. 28, A10.82. adjust and continue for as long as necessary. Max. S Mild reflux disease and associated 180mg daily. Take daily dose q120mg in two symptoms. Long-term management and divided doses. GORD: 15mg or 30mg once daily prevention of relapse in reflux oesophagitis (RO). (rapid relief). Moderate hepatic impairment: Max. Prevention of gastroduodenal ulcers induced by 15mg daily. non-selective non-steroidal anti-inflammatory Q Not recommended. drugs (NSAIDs) in patients at risk with need for D Severe hepatic impairment. Pregnancy, continuous NSAID treatment. P Mild reflux disease: 20mg daily; control lactation (no data). B Hepatic/renal dysfunction, elderly. recurrent symptoms with 20mg once daily ondemand regimen if required; consider switching to Exclude malignant gastric tumour. Long-term treatment (q1 year); review regularly. Driving/ continuous therapy if symptoms not controlled adequately. RO (long-term, prevention of relapse): using machines. C Avoid ketoconazole, itraconazole. 20mg daily; increase to 40mg daily if relapse Antacids, sucralfate (1 hr apart). Caution: CYP2C19 occurs. NSAID-induced gastroduodenal ulcers: /CYP3A4 substrates (eg. tacrolimus, 20mg daily. Impaired renal function: Max 40mg carbamazepine, phenytoin) and inhibitors, digoxin, daily. Hepatic impairment: Max 20mg daily. warfarin, theophylline, antibiotics. R Max 40mg daiy. A GI disorders, dyspepsia, headache, Q Not recommended. dizziness, eczema, urticaria, itching, fatigue. 2MO
1.1
duodenal ulcers, consider H. pylori infection as an etiological factor. Very rarely cases of colitis have been reported. Pregnancy (not recommended), lactation. C Contraindicated: Atazanavir. Avoid: Ketoconazole, itraconazole. Caution: Digoxin, drugs that are metabolised by CYP3A4 (incl. theophylline, tacrolimus), fuvoxamine, rifampicin, St John’s wort. Antacids and sucralfate (take 1 hour apart). A Headache, dizziness, GI disorders, increase in liver enzyme levels, urticaria, itching, rash, fatigue.
ZOTROLE
Pinewood
2MO
PPI. Lansoprazole 15mg, 30mg. White/redbrownish and white gel caps., resp. 15mg-28, A12.96; 30mg-28, A23.31. S Duodenal and gastric ulcer. Reflux oesophagitis (RO), long-term prophylaxis of RO. H. pylori eradication. Treatment and prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers. Symptomatic gastro-oesophageal reflux disease. Zollinger-Ellison syndrome (ZES). P Ulcers and RO: 30mg once daily swallowed whole with liquid into empty stomach; duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 weeks; double duration if not fully healed. Prophylaxis of RO: 15mg once daily; may be increased up to 30mg daily. Eradication of H. pylori: 30mg twice daily for 7 days in combination with either clarithromycin 250-500mg twice daily + amoxicillin 1g twice daily or clarithromycin 250mg twice daily + metronidazole 400-500mg twice daily. NSAID associated ulcers: 30mg once daily for 4 weeks, may be continued for another 4 weeks if not fully healed. Prophylaxis of NSAID associated ulcers: 15mg once daily. If fails, use 30mg once daily. Symptomatic gastro-oesophageal reflux: 15mg or 30mg once daily; adjust dose individually. ALSO ZOLEPANT 40MG Pantoprazole 40mg. Light ZOTON FASTAB Wyeth If symptoms not relieved in 4 weeks, increase to brownish yellow, oval, slightly biconvex tab. 28, 30mg daily. ZES: Initially 60mg once daily. 2 M O A20.04. Individually adjust and continue as long as PPI. Lansoprazole 15mg, 30mg. Oro-dispersible S Relief of symptoms and short-term necessary. Max. 180mg, if daily dose q 120mg treatment of GI diseases which require a reduction white-yellowish tabs. speckled with orange-dark admin. in 2 divided doses. Impaired renal function/ brown gastro-resistant microgranules debossed in acid secretion: Duodenal ulcer, gastric ulcer, mildly impaired hepatic function: Max. 30mg daily. A with 15 or 30 resp. 15mg-28, 18.26; 30mg-7, moderate and severe RO, eradication of H. pylori Moderately impaired hepatic function: Max. 15mg A9.08 (hospital only pack); 14, A19.78; 28, in combination with antibiotic therapy in patients daily. A36.29. with peptic ulcer, Zollinger-Ellison syndrome and R 15-30mg. Max. 30mg daily. S Duodenal and gastric ulcer. Treatment other hypersecretory conditions. Q Not recommended. and prophylaxis of reflux oesophagitis (RO). P Moderate to severe RO/ duodenal/ D Pregnancy, lactation (no data). Eradication of H. pylori concurrently given with gastric ulcer: 40mg daily. H. pylori eradication: appropriate antibiotics. Treatment and prophylaxis B Exclude possibility of malignant gastric 40mg twice daily in combination with either tumour. Caution: Hepatic dysfunction. Risk of GI of NSAID-associated benign gastric and duodenal amoxicillin 1g twice daily + clarithromycin 500mg infections. Treatment q 1 year: Review regularly, ulcers in patients requiring continued therapy. twice daily or clarithromycin 250-500mg + assess benefit against risks; if visual disturbances Symptomatic GORD. Zollinger-Ellison syndrome metronidazole 400-500mg twice daily or occur consult ophthalmologist. Gastro-duodenal (ZES). amoxicillin 1g twice daily + metronidazole 400ulcers, consider H. pylori infection as an etiological P Duodenal ulcer: 30mg once daily for 2 500mg twice daily. ZES: Initially 80mg daily. Doses factor. Contains sucrose. Driving/using machines. If or 4 weeks. Gastric ulcer/RO: 30mg once daily for q80 mg daily, divide dose and give twice daily. used in combination with antibiotics H. pylori 4 or 8 weeks. Prophylaxis of RO: 15-30mg once May be temporarily increased to q160mg (no eradication, follow antibiotics instructions. Colitis daily. ZES: 60mg once daily. See SPC. Hp longer than required for adequate acid control). may rarely occur. Restrict treatment to high risk eradication regimens: 30mg twice daily in Impaired renal function: Max 40mg daily. H.pylori combination with clarithromycin 250-500mg twice patients for the prevention of peptic ulceration in triple therapy not suitable. Severe hepatic daily and either amoxycillin 1g twice daily or patients needing continuous NSAIDs. impairment: Max 40mg every other day; H.pylori metronidazole 400-500mg twice daily for 7-14 C Avoid: Ketoconazole, itraconazole. triple therapy not suitable. days. NSAID-associated ulcers: Treatment, 15-30mg Caution: CYP2C19 and CYP3A4 inhibitors and R Max 40mg daily except for H. pylori once daily for 4 or 8 weeks. Prophylaxis, 15-30mg substrates (e.g. theophylline, carbamazepine). eradication (as per adults for 1 week). once daily. Digoxin, tacrolimus. Antacids and sucralfate (take Q Not recommended. R Max. 30mg daily. 1 hr apart). B For prescribing information, see Q Not recommended. A GI disorders, increase in liver enzymes pantoprazole Drug Presc. Notes. Contains sorbitol. B Exclude possibility of malignant gastric levels, urticaria, itching, rash, headache, dizziness, tumour. Hepatic dysfunction. Risk of GI infections. fatigue. ZOMEL Clonmel Treatment q 1 year: Review regularly. Contains 2MO lactose. Driving or using machines. Gastro1.2 CONSTIPATION AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
13
1.2 CONSTIPATION
ALIMENTARY SYSTEM 1 tab. night before and 1x5mg suppos. following
BABYLAX
Dr. Mann morning. Under 4 years, constipation: 1x5mg
2K
suppos.
Faecal softner/lubricant. Glycerol 1.8g, benzalkonium Cl 0.36g. 3.6g soln. in rectal applicator. 3, A5.48. S Constipation in adults, elderly and children of any age. P 1-2 applicators. Q Under 3 months, v-1 applicator; 3 months-6 years, 1 applicator; over 6 years, 1-2 applicators. B For single use only.
ALSO DULCO-LAX PERLES Sodium picosulfate 2.5mg. Small, pearl-shaped, soft gelatin caps. 50, A4.28. S Constipation. Bowel clearance before surgery, childbirth or radiological examinations. P 2-4 at night. Q Over 10 years, as for adults. 4 to10 years, 1-2 at night. Under 4 years, not recommended.
CELEVAC
2K
2
Amdipharm ALSO DULCO-LAX LIQUID Sodium picosulph. 5mg/
5ml. Liquid. 100ml, A2.76; 300ml, A7.78. S Constipation. Bowel clearance before surgery, childbirth or radiological examinations. P 5-10ml at night. Q Under 4 years, 250mcg/Kg BW; 410years, 2.5-5ml. Both at night. D Ileus, intestinal obstruction, acute surgical abdominal conditions like acute appendicitis, acute IBDs, and severe dehydration. B Children under 10 years (medical advice CODALAX Mundipharma required). Pregnancy, lactation (not recommended). 2MO C Diuretics or adreno-corticosteroids Faecal softner/stimulant. Poloxamer ’188’ 200mg, (increased risk of electrolyte imbalance). Broad dantron 25mg per 5ml. Liquid. 300ml, A4.33. spectrum antibiotics (reduced laxative action). 2MO A Abdominal discomfort (incl. pain and ALSO CODALAX FORTE Poloxamer ’188’ 1g, cramps), diarrhoea. danthron 75mg per 5ml. Liquid. 300ml, A14.50. S Treatment or prophylaxis of analgesic DUPHALAC Solvay induced constipation in terminally ill. 2O P 5-10ml at night. Osmotic. Lactulose 3.35g/5ml. Soln. 300ml, A1.14; Q 2.5-5ml at night. 1L, A3.44. 2MO S Constipation. Hepatic encephalopathy. ALSO CODALAX CAPSULES Poloxamer ’188’ P Constipation: Initially 15ml twice daily. 200mg, danthron 25mg. Light brown/orange cap. Encephalopathy: Initially 30-50ml 3 times daily; marked CX. 60, A13.33. adjust dose to produce 2 or 3 soft stools daily and P 1-2 at night. an acidic faecal pH. Q 1 at night. Q Constipation, 1 month-1 year: 2.5ml; 1-2 2MO years: 2.5-5ml; 2-5 years, 5ml; 5-10 years, 10ml. All ALSO CODALAX FORTE CAPSULES Poloxamer twice daily. ’188’ 500mg, danthron 35.5mg. Light brown/green D Galactosaemia. GI obstruction. cap. marked CXF. 60, A14.49. B Contains lactose. P 1-2 at night. C Avoid enteric coated mesalazine (5Q Not recommended. ASA). D Intestinal obstruction, acute painful A Flatulence. conditions of abdomen. Infants in nappies. FLEET De Witt Pregnancy. B Incontinence. 2 A Colouring of urine and perianal skin. Osmotic. Sodium acid phos. 21.4g, Na+ phos. 9.4g. 133ml single dose enema. 1, 84c. DULCO-LAX Boehringer Ing. SM S Constipation. Pre- and post-operatively 2K in obstetrics and prior to proctoscopy, sigmoidoscopy or X-ray. Stimulant. Bisacodyl 5mg. Yellow ent-ctd tab. 10, A1.21; 20, A2.01; 40, A3.89; 60, A4.64. P 1 enema once daily. S Evacuation of colon in constipation and Q Under 3 years not recommended; over 3 years, in proportion according to body weight. in preparation for radiological investigations. D Conditions where the absorbtive 2K ALSO DULCO-LAX SUPPOSITORIES Bisacodyl 5mg capacity of the colon is increased, CHF. B Restricted Na+ intake. and 10mg. Suppos. 5mg-5, A1.49; 10mg-10, A2.75; 20, A5.10. FYBOGEL CITRUS Reckitt Benckiser S Evacuation of colon in constipation and 2O in preparation for radiological investigations. Bulking agent. Ispaghula husk 3.5g. Citrus P Constipation: 1-2 tabs. at night or flavoured sugar-free and gluten-free grans. 1x10mg suppos. in morning. Diagnostic and Sachets-30, A2.48; 60, A4.96. preoperative preparation: 2-4 tabs. night before 2K and 1x10mg suppos. following morning. Q Over 10 years, same as adult. 4-10 years: ALSO FYBOGEL ORANGE Ispaghula husk 3.5g. Orange flavoured grans. Sachets-10, A1.97. Constipation: 1 tab. at night or 1x5mg suppos. in morning. Diagnostic and preoperative preparation: S Patients requiring a high-fibre regimen.
2
Bulking agent. Methylcellulose 500mg. Pink tab. 112, A3.58. S Constipation. Patients requiring a high fibre diet. P 3-6 night and morning with at least 300ml liquid. Q 6-12 years, half adult dose. B Pregnancy, adequate fluid intake.
14
P 1 sachet or 2 level 5ml spoonfuls in water morning and evening after meals. Q Under 12 years, only on medical advice. 6-12 years, v-1 level 5ml spoonful of the granules, depending on age and size, morning and evening. D Intestinal obstruction, colonic atony.
KLEAN-PREP
Helsinn Birex
2 Electrolytes/osmotic. PEG 3350 59g, anhydrous sod. sulph. 5.685g, sod. bicarb. 1.685g, KCl 0.7425g, aspartame 0.0494g, flavouring 0.378g. Sachets-4, A6.19; 4+container, A6.71. S GI lavage, preparation prior to diagnostic examination or surgery particularly for the large bowel. Short term laxative in constipation. P Orally 200-250ml every 10mins. for laxative until 1L of reconstituted soln. is consumed; for GI lavage until 4L reconstituted soln. consumed or rectal effluent is clear. Q Not recommended. D GI obstruction or perforation, ileus, gastric retention, acute intestinal or gastric ulceration, toxic colitis or megacolon. Body weight below 20kg. B UC, proctitis. A Bloating, abdominal cramps, vomiting, urticaria, allergic reactions.
LAXIDO ORANGE
Galen
2MO Laxative. Macrogol 3350 13.125g, NaCl 350.7mg, NaHCO3 178.5mg, KCl 46.6mg. Free flowing white powder for oral solution in a single-dose sachet. 30, A7.68. S Chronic constipation. Also effective in resolving faecal impaction. P Chronic constipation: Dissolve each sachet in 125ml water. 1-3 sachets daily in divided doses, according to individual response. Can be adjusted down to 1 or 2 sachets daily for extended use. Faecal impaction: 8 sachets daily within a 6 hour period. Dissolve each sachet as above or dissolve 8 sachets in 1 litre of water (store reconstituted solution covered at 2oC-8oC for up to 6 hours). Do not exceed 3 days. Impaired cardiovascular function, no more than 2 sachets to be taken in any 1 hour. Q Under 12 years, not recommended. Over 12 years, as per adults. D Intestinal obstruction or perforation caused by functional or structural disorder of the gut wall, ileus and in patients with severe inflammatory conditions of the intestinal tract. Pregnancy and lactation (unless clearly necessary). B Confirm faecal impaction diagnosis by appropriate physical or radiological examination of the rectum and abdomen. Stop immediately if symptoms indicating shifts of fluids/electrolytes develop (e.g. oedema, shortness of breath, increasing fatigue, dehydration, cardiac failure); measure electrolytes and treat any abnormality appropriately. Contains glucose and sulphur dioxide. C No other medicines to be taken orally for 1 hour before and for 1 hour after admin. A Abdominal distension and pain, borborygmi, nausea, mild diarrhoea.
LAXOSE
Pinewood
2O Osmotic. Lactulose 3.3g/5ml. 300ml, A1.87; 500ml, A3.87; 1L, A5.70.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM S Constipation. Hepatic encephalopathy. P Constipation: initially 15ml twice daily. Encephalopathy: initially 30-50ml three times daily adjusting to produce 2 to 3 soft stools daily. Q Constipation, 2-5 years, 5ml; 6-10 years, 10ml. Both twice daily. D Galactosaemia. GI obstruction.
Iso-osmotic laxative. Macrogol 3350 (polyethylene glycol 3350) 13.125g, NaCl 350.7mg, NaHCO3 178.5mg, KCl 46.6mg (on reconstitution: Na+ 65mmol/l, Cl- 53mmol/l, K+ 5.4mmol/l, HCO317mmol/l. Powder. Sachets: 20, A7.63; 30, A10.64. S Chronic constipation. Faecal impaction. P Constipation: 1-3 sachets daily in divided doses. Impaction: 8 sachets daily within a MESTINON Meda 6 hour period for up to 3 days. Impaired cardiovascular function: No more than 2 sachets in 2MO Anticholinesterase. Pyridostigmine bromide 60mg. any one hour. Reconstitute each sachet in 125ml water. White quarter-scored tab. marked ICN. 200, Q Under 12 years, not recommended. A53.85. 2MO S Paralytic ileus. ALSO MOVICOL PAEDIATRIC PLAIN Macrogol P 1-4 as required. 3350 (polyethylene glycol 3350) 6.563g, NaCl Q 15-60mg as required. 175.4mg, NaHCO3 89.3mg, KCl 25.1mg (on D Intestinal or urinary obstruction. reconstitution: Na+ 65mmol/l, Cl- 53mmol/l, K+ B Bronchial asthma, cardiac disease, 5.4mmol/l, HCO3- 17mmol/l). Powder. Sachets: 30, vagotonia, epilepsy, Parkinsonism. A7.14. C Depolarising muscle relaxants, S Chronic constipation. Faecal impaction. cyclopropane, halothane. Prevention of recurrence of faecal impaction. A Nausea, salivation, diarrhoea, colic. Q Chronic constipation/ prevention MICOLETTE Pinewood reimpaction: Under 2 years, not recommended. 2-6 years, Initially 1 sachet daily; 7-11 years, 2 sachets 2 daily adjusted every second day. Duration at least Faecal softener/lubricant. Sodium lauryl 6-12 months; max. 4 sachets a day. Faecal sulphoacetate 45mg, Na+ citrate 450mg, glycerol impaction: Under 5 years, not recommended. 5-11 625mg. Micro-enema. 12 x 5ml, A7.21. S Constipation. Bowel clearance pre- and years, initially 4 sachets a day. See SPC for full dosing recommendations. 12 years and older, use post-operatively or before rectal examination. Movicol. Reconstitute each sachet in 62.5ml P 1-2 enemas inserted to full length of (approx. t glassful) water. nozzle. Q Under 3 years, not recommended. Over D GI obstruction or perforation, ileus, severe inflammatory condition of intestinal tract 3 years, same as adults, insert nozzle to half (eg. Crohn’s disease, UC, toxic megacolon). length only. B Monitor for symptoms indicating shifts D Inflammatory or ulcerative bowel of fluid/electrolytes. Children with cardiovascular disease, acute GI conditions. or renal impairment; not recommended. MICROLAX McNeil Healthcare Pregnancy, lactation (only if essential). A Abdominal distension, nausea.
CONSTIPATION 1.2 particularly narrow therapeutic index or short half-life drugs, within one hour of admin. A Nausea, vomiting, bloating, abdominal pain, anal irritation, sleep disturbance, allergic reaction, hunger, hypophosphatemia, dizziness, headache, rigors.
NORMACOL
Norgine
2O Bulking agent. Sterculia 62%. White coated grans. Sachets-60 x 7g, A5.52; 500g, A6.57. S Constipation (incl. pregnancy and lactation). Management of colostomies and ileostomies. P 1-2 sachets or 1-2 heaped 5ml spoonfuls once or twice daily after meals taken unchewed with a drink. Q Under 6 years, not recommended; 6-12 years, half adult dose.
2 ALSO NORMACOL PLUS Sterculia 62%, frangula 8%. Brown coated grans. 200g, A4.53; 500g, A9.32. S Constipation. Initiation and maintenance of bowel action after rectal surgery or haemorrhoidectomy. P 1-2 heaped 5ml spoonfuls once or twice daily after meals swallowed unchewed with a drink. Q Under 6 years, not recommended; 6-12 years, in proportion to adult dose.
PICOLAX
Ferring
2
Stimulant/osmotic laxative. Na+ picosulph. 10mg, magnesium oxide 3.5g, citric acid 12.0g. Powder. Sachets-1 x 2, A6.29. S Bowel clearance before radiography, endoscopy or surgical procedures. 2K P 1 sachet reconstituted in water and Faecal softener/lubricant. Sodium citrate 450mg, MOVIPREP Norgine taken before 8h00 on day prior to procedure, repeat 6-8 hours later. Na+ lauryl sulphoacetate 45mg, sorbic acid 5mg 2N Q Not recommended. per 5ml. Disposable enema. 50, A27.21. Laxative. Sachet A: Macrogol 3350 100g, sodium D CHF, gastric retention, GI ulceration, S Constipation, evacuation of the colon prior to surgical and diagnostic procedures and in sulphate anhydrous 7.5g, NaCl 2.691g, KCl 1.015g. toxic colitis/megacolon, ileus, nausea and Sachet B: Ascorbic acid 4.7g, sodium ascorbate vomiting, acute surgical abdominal conditions, GI obstetrics prior to delivery. 5.9g. Free flowing powder. Sachet A: White to obstruction/perforation. Severe renal impairment. P 1 enema as required yellow. Sachet B: White to light brown. 4 sachets Impaired consciousness, general weakness. Patients Q Under 3 years, insert half nozzle only; (2 x sachet A and B), A13.26. with a tendency to aspiration or regurgitation or over 3 years, same as adult. S Bowel cleansing prior to bowel impaired swallowing reflex. B IBD. Acute GI conditions. endoscopy or radiology. B Recent GI surgery. Caution: Renal MIL-PAR Seven Seas P One sachet A and one sachet B impairment, heart disease or IBD. Patients at risk dissolved together in 1L of water to be drunk over of hypokalaemia. Monitor for signs of 2 period of 1-2 hrs the evening before day of hyponatraemia (correct promptly). Elderly, Osmotic/faecal softner. Magnesium hydroxide procedure. Repeat with a second litre of product, debilitated patients and at risk patients (those 300mg, liquid paraffin 1.25ml per 5ml. Oral susp. either the evening before or the morning of day with increased risk for underlying renal 200ml, A2.73; 500ml, A4.20. of procedure, at least 1hr before procedure. impairment, electrolyte disturbance, acute MI, S Temporary relief of occasional Q Under 18 years, not recommended. unstable angina); maintain adequate hydration constipation. D GI obstruction or perforation, disorders and monitor baseline and post treatment P 15-30mls before breakfast or at of gastric emptying (e.g. gastroparesis), ileus, toxic electrolytes. Advise low residue diet before and bedtime. megacolon complicating inflammatory conditions 250ml/hour water/other clear fluid intake during Q 2-7 years: 5-10ml; over 7 years: 7.5-15ml. of the intestinal tract eg. Crohn’s disease and treatment. Use for 24 hour max. Pregnancy, Taken at bedtime. ulcerative colitis, unconsciousness. caution. D Children Q 2 years old. B Diarrhoea expected outcome. Caution: C Absorption of concomitant oral B Caution: Swallowing difficulties. Not for Fragile, poor health, serious clinical impairment medication may be modified. Bulk-forming use if symptoms of appendicitis, intestinal (cardiac impairment NYHA grade III), laxatives. Caution: Drugs associated with obstruction, IBD, abdominal pain of unknown dehydratation (correct before use), severe acute hypokalaemia, NSAIDS or drugs known to induce origin. Contains Mg++ salts. Consult doctor if inflammatory disease. Impaired consciousness, SIADH (e.g. TCAs, SSRIs, antipsychotics, needed every day, persistent abdominal pain/ impaired gag reflex, tendency to aspiration of carbamazepine). symptoms. Consult doctor before use if taking regurgitation: Closely monitor, especially if medication, suffer from kidney disease or under nasogastric admin. Poor health, ccQ30ml/min, risk REGULAN P & GP doctor’s care. Prolonged use. of electrolyte imbalance: Baseline and post2O treatment electrolyte renal function test needed. MOVICOL Norgine Pregnancy, lactation (only if essential). Bulking agent. Ispaghula husk 3.4g flavoured, 2MO C Do not take oral medication, sugar-, gluten-free powder or 3.6g flavoured, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
15
1.3 DIARRHOEA
ALIMENTARY SYSTEM
sugar-, gluten-free powder. Sachets. 30, A2.16. S Constipation. To increase daily fiber intake. P 1 sachet in water one to three times daily. Q 6-12 years, v-1 level teaspoonful in water one to three times daily. Over 12 years, as per adults. D Intestinal obstruction, faecal impaction, colonic atony . B Supervise treatment in the elderly or debilitated and patients with intestinal narrowing or decreased motility (GI obstruction risk). Contains phenylalanine, sunset yellow. A Temporary increase in flatulence and abdominal distension.
RELISTOR
Wyeth
2O Peripheral opioid receptor antagonist. Methylnaltrexone bromide 12mg/0.6ml (20mg/ml). Sterile, clear, colourless to pale-yellow sln for inj. in vial. 0.6ml-1; 0.6ml-7. Prices on request. S Opioid-induced constipation in advanced illness patients receiving palliative care when response to usual laxative therapy not sufficient. P 1 single dose every other day as a subcutaneous inj. May be given at longer intervals, if needed. 2 consecutive doses 24 hrs apart may be given only when there has been no response to the dose on the preceding day. Recommended dose: 8mg (0.4ml) (patients weighing 38-61kg) or 12mg (0.6ml) (patients weighing 62-114kg). See SPC. Q Not recommended. D Known or suspected mechanical gastrointestinal obstruction or acute surgical abdomen. Pregnancy (unless clearly necessary). B Not recommended: Severe hepatic impairment or end-stage renal impairment requiring dialysis. Not indicated for non-opioid induced constipation. Can result in the rapid onset of a bowel movement (within 30-60 min). Use only for a limited period. Caution: Patients with colostomy, peritoneal catheter, active diverticular disease or faecal impaction (no data). Lactation. A Dizziness, GI disturbances, injection site reactions.
SENOKOT
Reckitt Benckiser
2 Stimulant laxative. Sennoside B (as total sennosides) 7.5mg. Brown tab. marked with tab name and a sword. 20, A2.62; 60, A5.46; 100, A7.26; 500, A18.77.
2 ALSO SENOKOT SYRUP Sennoside B (as total sennosides) 15mg/10ml. 150ml, A5.19. S Occasional constipation. P 2-4 tabs. or 10-20ml syrup at bedtime. If no bowel action after 3 days, consult doctor. Q Under 12 years, not to be given except on medical advice. If admin. to children necessary: 2-6 years, 2.5-5ml syrup in 24 hrs; over 6 years, half adult dose. Both in the morning. Under 2 years, not recommended. D Undiagnosed acute or persistent abdominal symptoms.
TOILAX
Orion
2 Bisacodyl 10mg/5ml. 5, A3.73; 50, A29.76. S Constipation, evacuation of colon.
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P Constipation: 1-2 tabs. in the evening or 1 enema. Surgical preparation: 4 tabs. in two divided doses on the day prior to examination. Use enema on morning of examination. Q Constipation: Over 2years, 1-2 tabs. (0.3mg/kg body weight) or 1 enema; under 2years, v enema. Children insert half nozzle only. D Inflammatory or ulcerative conditions of large bowel.
inhibition or peristalsis is to be avoided. B Severe acute UC. Pregnancy. Defective hepatic function. A Rashes.
IMODIUM PLUS
McNeil Healthcare
2K
Antipropulsive antidiarrheals. Loperamide (HCl) 2mg, simeticone equiv. to polydimethylsiloxane 125mg. White, capsule-shaped tab. 12, A6.05. 1.3 DIARRHOEA S Acute diarrhoea associated with gasDIORALYTE sanofi-aventis related abdominal discomfort incl. bloating, cramping or flatulence. 2O P 2 tabs. initially, followed by 1 tab. after Electrolytes. Sodium chlor. 0.47g, K+ chlor. 0.30g, every loose stool. Max R 4 tabs. in 1 day. disodium hydrogen citrate 0.53g, glucose 3.56g. Duration R 2 days. Powder in sachet (plain, flavoured). 20, A4.68. Q 12-18 years: 1 tab. initially, followed by S Oral correction of fluid and electrolyte 1 tab. after every loose stool. Max R 4 tabs. in 1 loss and management of watery diarrhoea. day. Duration R 2 days. Under 12 years, P 20-40ml/kg daily. (Approx. 1-2 sachets contraindicated. after every loose motion). Reconstitute 1 sachet D Children Q 12 years. Acute dysentery, with 200ml fresh drinking water. acute UC, pseudomembranous colitis associated Q Children: As per adults except with broad spectrum antibiotics. Bacterial reconstitute 1 sachet after every loose motion. enterocolitis caused by invasive organisms. When Infants: 1 to 1v times the usual feed vol or 150ml/ inhibition of peristalsis is to be avoided due to risk kg daily. Infants under 12 months: Only under of significant sequelae incl. ileus, megacolon, toxic medical advice. megacolon. Discontinue if constipation, subileus, B Only reconstitute with water at volume abdominal distension develop. Pregnancy (unless stated. Severe renal/hepatic impairment or other clinically justified), lactation. conditions where normal electrolyte balance is B Fluid and electrolyte depletion may distributed. If nausea and vomiting present, drink occur. No improvement within 48 hours, small but frequent amounts at first. If no discontinue and consult physician. AIDS patients, improvement within 24-36 hr consult physician. stop therapy at sign of abdominal distension. Toxic megacolon in AIDS patients with infectious ELECTROLADE Eastern colitis treated with loperamide HCI has been 2 reported rarely. Hepatic insufficiency (caution); hepatic dysfunction (monitor); severe hepatic Electrolytes. Sodium chlor. 236mg, K+ chlor. dysfunction (use under medical supervision). 300mg, Na+ bicarb. 500mg, glucose 4g. Powder Driving using machines, if dizziness occurs. (flavoured) in sachets. 6, A1.39; 20, A4.43. S Dehydration associated with diarrhoea. A Nausea, taste perversion. P 1-2 sachets after every loose motion, LOMOTIL Goldshield max. 16 in 24 hours. Reconstitute 1 sachet in 200ml water. 2MO Q Under 2 years, 1-1v times normal feed Opiate/anticholinergic. Diphenoxylate (HCl) 2.5mg, volume; over 2 years, 1 sachet after every loose atropine sulph. 25mcg. White tab. marked SEARLE. motion, max. 12 in 24 hours. 100, A11.52; 500, A57.56, 1000, A115.09. D Renal impairment. S Diarrhoea. P 4 initially then 2 every six hours until IMODIUM McNeil Healthcare control. Q Under 4 years, not recommended; 4-8 2MO years, 1 three times daily; 9-12years, 1 four times Opiate. Loperamide (HCl) 2mg. Dark green/grey daily; 13-16years, 2 three times daily. A cap. 60, 5.11. D Intestinal obstruction. Acute ulcerative S As an adjunct in the management of colitis. Pseudo-membranous colitis. Jaundice. diarrhoea. B Hepatic dysfunction. Concurrent admin. P Adults and children 9-12 years, 2-4mg of narcotics or sedatives. Pregnancy, lactation. initial dose, followed by 2mg 3 times daily. Max. Correct severe dehydration and electrolyte daily dose 10mg. Q 4-8 years, total max. 4mg.Under 4 years, imbalance before initiating therapy. C CNS depressants. MAOIs. not recommended. A CNS disturbances, allergic reactions, 2MO gastrointestinal upset. Anticholinergic effects. ALSO IMODIUM ORAL SOLUTION Loperamide (HCl) 1mg/5ml. Slightly viscous soln. 100ml, A2.21. QUESTRAN BMS S Adjunct in the management of 2MO diarrhoea. Symptomatic control of diarrhoea Ion-exchange resin. Cholestyramine 4g. Powder in associated with chronic bowel disorders. sachet. 50, A24.32. P 2-4mg (10-20ml) initially followed by 2mg (10ml) three times daily. Max. daily dose S Relief of diarrhoea associated with ileal 10mg. Chronic bowel disorders. initially 4-8mg resection, Crohn’s disease, radiation, vagotomy daily in two divided doses and adjust according to and diabetic vagal neuropathy. Pruritus associated response with partial biliary obstruction. Q Under 4 years, not recommended; 4-8 P Diarrhoea, 12-24g daily in divided doses; years, max. daily dose of 4mg in divided doses; 9- max. 36g daily. Pruritus, 4-8g daily. 12 years, as adult dose. Q Under 6 years, not recommended; over D Use in children under 4 years or when 6 years, in proportion to dose for 70kg adult.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM D Complete biliary obstruction. B On long term, suppl. diet with vitamins A, D and K. Pregnancy, lactation. Contain sucrose. C Digitalis, antibiotics, diuretics. Take all drugs 1 hour before or 4-6 hours after Questran. A Constipation.
ANO-RECTAL CONDITIONS, A Systemic corticosteroid effects.
ASACOLON
COLITIS
COLIFOAM
1.4 Meda
Tillotts 0 N O
2MO
Salicylate. Mesalazine 400mg, 800mg. Red-brown resin-coated oblong tabs. 400mg-100, A27.29; 1.4 ANO-RECTAL CONDITIONS, COLITIS 800mg-90, A63.04. S Treatment of mild acute ulcerative ANUGESIC-HC Parke-Davis colitis. Maintenance of remission of ulcerative colitis. Maintenance of surgically-induced remission 0NO of Crohn’s disease. Soothing/antiseptic/steroid. Pramoxine (HCl) 1%, hydrocortisone (acetate) 0.5%, zinc oxide 12.33%, P UC: Induction of remission, 2.4g daily in Peru balsam 1.8%, benzyl benzoate 1.2%, bismuth divided doses increasing to 4g if required; oxide 0.87%, resorcinol 0.87%. Cream. 30g, A7.17. maintenance, 1.2-2.4g daily in divided doses. Crohn’s disease: Maintenance of remission, 2.4g 0NO daily in divided doses. ALSO ANUGESIC-HC SUPPS Pramoxine (HCl) Q Not recommended. 27mg, hydrocortisone (acetate) 5mg, bismuth 2MO subgallate 59mg, zinc oxide 296mg, Peru balsam ALSO ASACOLON SUPPS Mesalazine 500mg 20, 49mg, benzyl benzoate 33mg, bismuth oxide A14.42. 24mg. Buff coloured suppository. 12, A3.05. S Proctitis and proctosigmoiditis. Adjunct S Severe and acute discomfort or pain to oral therapy in severe generalised ulcerative associated with internal and external colitis affecting the rectum and rectosigmoid haemorrhoids, proctitis, cryptitis, anal fissures, colon. pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures. P 1 inserted up to three times daily after P 1 suppos. or application of cream night defecation depending on the severity of the disease and reducing dose as condition improves. and morning and after defaecation. In severe cases insert 1 morning and evening as an Q Not recommended. D Tuberculous, fungal and viral infections. adjunct to oral therapy. Q Not recommended. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects. Transient D Hypersensitivity to salicylates. Severe renal impairment. Lactation. burning on application. B GI tract obstruction. Renal impairment ANUSOL McNeil Healthcare and raised blood urea or proteinuria. Elderly. Pregnancy. 2 Soothing/antiseptic/astringent. Bismuth subgallate C Lactulose. Products that decrease stool pH. 59mg, bismuth oxide 24mg, Peru balsam 49mg, A Gl disturbances, headache, blood zinc oxide 296mg/2.8g. Suppos. 12, A3.62; 24, dyscrasias, hepatic and renal reactions, A6.29. pancreatitis. 2K
Steroid. Hydrocortisone acetate 10%. Mucoadherent foam in aerosol. 20g (approx. 14 applications) plus applicator, A8.44. S Ulcerative colitis, proctosigmoiditis, granular proctitis. P 1 applicatorful inserted into the rectum once or twice daily for 2-3 weeks and every second day thereafter. Q Not recommended. D Obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses and extensive fistulae. Tuberculous, fungal or viral infections. B Severe ulcerative disease. Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
DIPENTUM
UCB
2MO Salicylate. Olsalazine Na+ 500mg yellow scored tab. 250mg beige cap. 500mg-60, A33.25; 250mg112, A31.04. S Treatment of mild-moderate acute ulcerative colitis and maintenance of remission. P Initially 1g daily I divided doses increasing to max. 3g daily, maintenance dose 500mg twice daily. Must be taken with food. Q Not recommended. D Hypersensitivity to salicylates, severe renal impairment. Pregnancy. A GI upset, headache, arthralgia, rash.
ENTOCORT CR
AstraZeneca
0MO
Corticosteroid. Budesonide 3mg. Grey/pink cap. marked with strength and CIR containing controlled-release ent-ctd granules. 100, A96.68. S Induction of remission in mild to moderate Crohn’s disease affecting the ileum and/ ALSO ANUSOL CREAM Zinc oxide 10.75%, BUDENOFALK Dr Falk or the ascending colon. bismuth oxide 2.14%, Peru balsam 1.8%. Cream. 0NO P 3 caps. once daily in the morning, for 23g, A3.50. Glucocorticoid. Budesonide 3mg. Hard, pink, up to 8 weeks, taken before meals. 2K A gastro-resistant cap. 100, 93.50. Q Not recommended. ALSO ANUSOL OINTMENT Zinc oxide 10.75%, B Caution: Bacterial, fungal or viral S Induction of remission in patients with bismuth oxide 0.87%, Peru balsam 1.87%, bismuth mild to moderate active Crohn’s disease affecting infections, hypertension, diabetes mellitus, subgallate 2.25%. Oint. 25g, A3.50. osteoporosis, peptic ulcer, glaucoma, cataracts, the ileum and/or the ascending colon. S Haemorrhoids, pruritus ani- and other family history of diabetes or glaucoma, chicken Symptomatic relief of chronic diarrhoea due to ano-rectal conditions. pox, measles, surgery, liver dysfunction. Withdraw collagenous colitis. P 1 suppos. or application of cream or oint. night and morning and after defaecation. P 1 cap. 3 times daily about half an hour gradually. Pregnancy, lactation. C Cholestryamine, ketoconazole. Avoid Q Not recommended. before meals, swallowed with plenty of fluid. grapefruit juice. Max. duration: 8 weeks. ANUSOL HC McNeil Healthcare Q Not recommended (insufficient A Cushingoid features, hypokalaemia, behavioural changes, blurred vision, palpitations, experience). 0N dyspepsia, skin reactions (urticaria, exanthema), D Hepatic cirrhosis with signs of portal Steroid/antiseptic/astringent. Hydrocortisone muscle cramps, menstrual disorders. hypertension. Pregnancy, lactation. (acetate) 10mg, benzyl benzoate 33mg, bismuth B Increased susceptibility to infections. subgallate 59mg, bismuth oxide 24mg, resorcinol HUMIRA Abbott Caution: Tuberculosis, hypertension, diabetes 24mg, Peru balsam 49mg, zinc oxide 29mg. A mellitus, osteoporosis, peptic ulcer, glaucoma, 2NT Suppos. 12, 4.06. cataracts, family history of diabetes or of 0NO Tumour necrosis factor (TNF) antagonist. glaucoma, exposure to chickenpox or measles, live Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled ALSO ANUSOL HC OINTMENT Hydrocortisone (acetate) 0.25%, benzyl benzoate 1.25%, bismuth vaccines, severe liver dysfunction. Withdraw pen or pre-filled syringe (2 per pack). Price subgallate 2.25%, bismuth oxide 0.87%, resorcinol gradually. available on request. C CYP3A4 inhibitors. Caution: CYP3A4 0.87%, Peru balsam 1.87%, zinc oxide 10.75%. S Severe, active Crohn’s disease in patients inductors or substrates, steroid-binding resins and who have not responded despite full and 15g, A5.10. S Haemorrhoids and inflammation of ano- antacids (take 2 hours apart), cardiac glycosides, adequate course of therapy with corticosteroid saluretics. rectal area. and/or immunosuppressants; or who are intolerant A Depression, irritability, euphoria, P 1 suppos. or application of oint. night to or have medical contraindications for such glaucoma, cataract, hypertension, thrombosis, and morning and after defaecation. therapies. Induction treatment, admin. in vasculitis, duodenal ulcer, pancreatitis, skin Q Not recommended. combination with corticosteroids; if corticosteroids D Tuberculous, fungal and viral infections. disorders, systemic steroid effects, increased risk inappropriate then admin. as monotherapy. B Avoid prolonged use. Pregnancy. P 80mg at week 0, followed by 40mg at infections, metabolism and nutrition disorders. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
17
1.4 ANO-RECTAL
CONDITIONS, COLITIS
week 2; and then 40mg once fortnightly via SC injection. If need for more rapid response to therapy: 160mg at week 0, 80mg at week 2, can be used (higher risk of adverse events during induction). Q Under 18 years, not recommended. D Active tuberculosis, other severe infections (sepsis), uncontrolled / opportunistic infections. Moderate to severe HF. Pregnancy, lactation. B Monitor for infections, incl. tuberculosis, before, during and after treatment; discontinue if serious. Do not initiate if active, chronic or localised infection unless controlled. Pre-existing or recent-onset CNS demyelinating disorders, mild HF (caution), COPD, heavy smokers. Use adequate contraception, avoid breastfeeding and pregnancy for 5 months after last treatment. Malignancies incl. lymphoma, demyelinating disease, HBV reactivation, pancytopenia reported. C Increased antibody formation and Humira clearance when admin. without methotrexate. Live vaccines, anakinra (not recommended), immunosupressants (caution). A Inj. site reaction, upper and lower respiratory infections, viral/bacterial infections, candidiasis, dizziness, headache, neurological sensation disorders. Cough, nasopharyngeal pain, diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, dermatitis, eczema, hair loss, musculoskeletal pain, pyrexia, fatigue.
ALIMENTARY SYSTEM
ALSO PENTASA SUPPOSITORIES Mesalazine 1g. Suppos. 28, A50.24. S Treatment of ulcerative proctitis. P Acute, 1 rectally twice daily for two to four weeks. Maintenance, 1-2 daily. Q Under 2 years, contraindicated. Over 2 years, 20-30mg/kg body weight daily divided into several doses when possible.
Ferring
2MO PENTASA RECTAL SUSPENSION. Salicylate. Mesalazine 1g. Enema. 7 x 100ml, A24.79. S Management of active ulcerative colitis. P 1 at bedtime for 2-3 weeks. Q Under 2 years, contraindicated. Over 2 years, reduced dose according to body weight.
2MO
18
PREDSOL
UCB
0NO
Steroid. Prednisolone (as disodium phos.) 20mg. Enema. 7 x 100ml, A6.09. S Ulcerative colitis. Crohn’s disease. ALSO PENTASA PR 500MG TABLETS Mesalazine P 1 at night for 2-4weeks. 500mg. White grey to pale brown prolongedQ Not recommended. release scored tab. marked with tab. strength and D Tuberculosis, bacterial, fungal and viral PENTASA. 100, A41.13. infections. S Ulcerative colitis and Crohn’s disease. B Avoid prolonged use. Severe disease. P Acute treatment (colitis/Crohn’s): Up to Pregnancy, lactation. 4g daily in 2 or 3 divided doses. MaintenanceC Rifampicin, rifabutin, carbamazepine, colitis: 2g once daily; Maintenance-Crohn’s: Initially phenobarbitone, phenytoin, primidone, 1.5g daily in 2 or 3 divided doses. aminoglutethimide, hypoglycaemics, Q Under 2 years, not recommended. Over antihypertensives, diuretics, coumarin, salicylates. 2 years, acute treatment, 20-30mg/kg body weight A Systemic corticosteroid effects. daily in two or three divided doses.
2MO
PREPARATION H
2MO
ALSO PENTASA SACHET Mesalazine 1g, 2g. White-grey to white-brown prolonged-release grans. in sachet. 1g-50, A46.55. 2g-60, A97.92. S Mild to moderate ulcerative colitis. P Acute, up to 4g daily divided into 2 to 4 doses, placed on the tongue and washed down with water or orange juice (must not be chewed). Maintenance, 2g once daily. Q Under 12 years, contraindicated. D Pregnancy/ lactation (except if benefit outweighs risk). Rectal Suspension/Suppositories/ MEZAVANT XL Shire Tabs: Children Q2 years, active peptic ulcer, 2MO coagulopathy, severe liver and/or renal impairment. Sachets: Children Q12 years. Salicylate. Mesalazine 1200mg. Red-brown, B Caution: Hepatic, renal impairment, ellipsoidal, film-ctd, gastro-resistant prolonged haemorrhagic diathesis, active peptic ulcer, allergy release tab, debossed with S476 on one side. 60, A71.47. to sulphasalazine. Monitor: Renal and liver function, differential blood counts. May occur: S Induction and maintenance of clinical Renal dysfunction (nephrotoxicity risk increased by and endoscopic remission of mild to moderate, concomitant NSAIDs and azathioprine), cardiac active ulcerative colitis. P Induction of remission: 2.4 to 4.8g once hypersensitivity reactions (myo- and pericarditis), blood dyscrasias (perform blood test if suspected). daily with food. 4.8g/day recommended for C Caution: Known nephrotoxic agents patients not responding to lower doses (evaluate (incl. NSAIDs and azathioprine), 6-mercaptopurine. treatment after 8 weeks). Maintenance: 2.4g/day. A Headache, diarrhoea, abdominal pain, Q Under 18 years, not recommended. nausea, vomiting, rash. D Severe renal impairment (GFR Q30ml/ 2 min/1.73m ) and/or severe hepatic impairment. PERINAL SPRAY Dermal B Serious blood dyscrasias may occur; 2MO discontinue and perform haematological investigations. Risk of hypersensitivity reactions: Steroid/local anaesthetic. Hydrocortisone 0.2%, Conditions predisposing to myo- or pericarditis, lignocaine (HCl) 1%. Soln. in a metered dose chronic lung function impairment (especially pump spray. 30ml, A7.26. asthma). Caution: Mild to moderate renal S Anal and perianal pain and pruritus impairment, hepatic impairment, allergy to such as associated with haemorrhoids. sulphasalazine. Renal impairment may occur. P Spray twice over affected area, up to Pregnancy (caution at high doses), lactation (if three times daily. benefit outweighs risk). Q Not recommended. C Caution: Known nephrotoxic agents D Bacterial, viral or fungal infections. (incl. NSAIDs and azathioprine), thiopurine B Avoid prolonged use. Pregnancy. methyltransferase, coumarin-type anticoagulants A Systemic corticosteroid effects. e.g. warfarin (closely monitor). A Headache, flatulence, nausea. PREDFOAM Forest
PENTASA RANGE
D Peritonitis, fistulae, obstruction, perforation, infections. B Avoid prolonged use. Pregnancy.
0NO Steroid. Prednisolone (as metasulphobenzoate Na+) white mucoadherent foam in aerosol. 20mg per metered dose. 25g (14 dose) plus disposable applicators, A9.76. S Proctitis, ulcerative colitis. P 1 metered dose inserted rectally once or twice daily for 2 weeks, continue for a further 2 weeks if good response. Q Not recommended.
Wyeth Healthcare
2 Soothing/antiseptic. Alcohol soluble extract of live yeast cells 1%, shark liver oil 3%. Rectal ointment. 25g, A3.64. S Haemorrhoids. P Application of oint. morning and night and after defaecation. Q Not recommended.
PROCTOFOAM HC
Meda
0MO Steroid/local anaesthetic. Hydrocortisone acetate 1%, pramoxine (HCl) 1%. Mucoadherent foam in aerosol. 21.2g plus applicator, A5.63. S Haemorrhoids, proctitis, cryptitis, fissures. P 1 applicatorful in the rectum 2 or 3 times daily and after defaecation. Perianally, apply as needed. Q Not recommended. D Tuberculous, fungal or viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
PROCTOSEDYL
sanofi-aventis
0NO Steroid/local anaesthetic/antibiotic. Hydrocortisone 5mg, cinchocaine (HCl) 5mg, framycetin sulph. 10mg, esculin 10mg. Suppos. 12, A3.44.
0NO ALSO PROCTOSEDYL OINTMENT Hydrocortisone 0.5%, cinchocaine (HCl) 0.5%, framycetin sulph. 1%, esculin 1%. 30g, A7.62. S Haemorrhoids, anal fissure, inflammation, pruritus. V 1 suppos. and/or application of oint. morning and night and after defaecation. D Tuberculous, fungal and viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
RECTOGESIC
Clonmel
2MO Nitrate. Glyceryl trinitrate 4mg/g. Ointment. 30g, A44.02. S Relief of pain associated with chronic anal fissure. P 375mg (measured using dosing line on carton) applied intra-anally every 12 hours. Continue until pain abates, up to max. 8 weeks. Q Under 18 years, not recommended.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM
ANO-RECTAL CONDITIONS,
D Previous idiosyncratic reactions to other organic nitrates. Postural hypotension, hypotension or uncorrected hypovolaemia; increased intracranial pressure or inadequate cerebral circulation; migraine or recurrent headache; aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy; constrictive pericarditis or pericardial tamponade; marked anaemia or closed-angle glaucoma. B Severe hepatic or renal disease. Avoid excessive hypotension. Monitor for hypotension/ tachycardia in patients with acute MI or CHF. If bleeding associated with haemorrhoids increases, stop treatment. Contains propylene glycol, lanolin. If anal pain persists exclude other causes. Pregnancy, lactation; not recommended. Driving or using machines. C Contra: Sildenafil citrate, tadalafil, vardenafil, NO donors e.g. isosorbide dinitrate and amyl or butyl-nitrite. Caution: Other vasodilators, Ca++ channel blockers, ACE inhibitors, b-blockers, diuretics, anti-hypertensives, TCAs, major tranquillisers, alcohol, dihydroergotamine, acetylsalicylic acid, NSAIDs. A Headache, dizziness, nausea.
REMICADE 2N
Soothing/antiseptic/astringent. Bismuth subgallate 2%, zinc oxide 8%, menthol 1%. Cream. 26g, A3.40. S Haemorrhoids, anal irritation. P Apply three times daily and after defaecation. For internal haemorrhoids use cannula nozzle. Q Not recommended.
SALAZOPYRIN
1.4
recurrance, 1 suppos. three times daily. Q Under 10 years, not recommended.
2MO ALSO SALOFALK ENEMA Mesalazine 4g. 7, A49.46. S Ulcerative colitis. P 1 daily before retiring. Q Under 10 years, not recommended.
2MO ALSO SALOFALK GRANULES Mesalazine 500mg,
Pharmacia 1000mg. 500mg-100, A41.55; 1000mg-50, A41.55.
S Acute episodes and maintenance of remission of ulcerative colitis. P Acute treatment: 3 sachets of Salofalk 500mg or 1000mg once daily preferably in the morning; alternatively 1 sachet of Salofalk 500mg 2MO or 1000mg 3 times daily (equiv. 1.5-3g daily) as ALSO SALAZOPYRIN EN-TABS Sulphasalazine required; usual duration 8-12 weeks. Maintenance: 500mg. Orange/yellow ent-ctd oval tab. marked 1 sachet of Salofalk 500mg 3 times daily. Swallow KPh one side and 102 on reverse. 112, A13.27. S Ulcerative Colitis. Active Crohn’s Disease. without chewing, with plenty of liquid. Q Under 6 years, not recommended. Over P Attack, 2-4 tabs. four times daily in 6 years and adolescents, acute treatment: 30conjunction with steroids. Maintenance, 4 tabs. a 50mg/kg/day once daily preferably in the morning day. or in 3 divided doses; maintenance: 15-30mg/kg/ Q Under 2 years, not recommended. day in 2 divided doses. Usually: Up to 40kg, half Others: Attack or relapse, 40-60mg/kg body adult dose; above 40kg, normal adult dose. Schering-Plough weight daily. Maintenance, 20-30mg/kg daily. 2MO
2MO
Salicylate-sulphonamide. Sulphasalazine 500mg. Orange/yellow round tab. marked kPh on one side and 101 on the other. 112, A9.41.
2MO
Monoclonal antibody. Infliximab 100mg. Powder for conc. for soln. in vial. 1, A690.43. S Severe active Crohn’s disease, fistulising Crohn’s disease and moderate/severe active ulcerative colitis where conventional therapy (eg. corticosteroids, immunosuppressants, 6-MP or AZA) is inappropriate or ineffective. P Crohn’s/UC: 5mg/kg IV inf. over 2 hrs, repeat after 2 and 6 weeks. Repeat inf. every 8 weeks; alternatively re-admin. inf. if symptoms recur. Discontinue use if no response following initial inf. after 2 doses in severe active and after 3 doses in fistulising active and UC. Crohn’s re admin.: Within 16 weeks following last inf. Q Crohn’s in 6-17 year olds: 5mg/kg IV inf. over 2 hrs, repeat after 2 and 6 weeks. Follow with inf. every 8 weeks. D TB (must be screened for active/ inactive), severe infections eg. sepsis, abscesses. Moderate/severe HF. Women should use adequate contraception and should not breastfeed during treatment and within 6 months of last dose. B Monitor for acute inf. reactions during/ within a few hours of inf. If necessary interrupt immediately. Ensure emergency equip. and treatment available. Monitor patients retreated after a long period. Caution: Chronic infection or recurrent infections. Discontinue if patient develops symptoms of lupus-like syndrome, antinuclear antibodies or serious infection. Elderly, hepatic impairment, mild heart failure. Increased risk of malignancies (caution with heavy smokers, history of malignancy). UC patients: Regularly screen for dysplasia. Crohn’s: Rare cases of hepatosplenic T-cell lymphoma reported. Paediatric Crohn’s: If possible, bring up to date with all vaccinations before initiating Remicade therapy. C Anakinra, live vaccines (not recommended). A Viral infection, serum sickness-like reactions, headache, vertigo, flushing, RTIs, dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC tissue disorders, fatigue, chest pain, fever, elevated hepatic transaminases, inf. reactions.
ROWATANAL
2
COLITIS
ALSO SALAZOPYRIN SUSPENSION Sulphasalazine 250mg/5ml. Orange-lemon flavoured susp. 500ml, A18.50. P 20-40ml four times daily for 2-3 weeks. Maintenance, 10ml 3-4 times daily. Interval between doses should not exceed 8 hrs. Q Under 2 years, not recommended. Others: Attack or relapse, 40-60mg/kg body weight daily. Maintenance, 20-30mg/kg daily.
2MO ALSO SALAZOPYRIN SUPPOSITORIES Sulphasalazine 500mg. Orange/yellow Suppos. 10, A3.43. P 2 morning and night after defaecation. Reduce after 3 weeks if improvement allows. Q Under 2 years, not recommended. Others, reduce dose in proportion to body weight. Oral and rectal may be used simultaneously. D Jaundice, porphyria. Pregnancy (unless essential). B Hepatic/renal dysfunction, blood dyscrasias; great caution. Regular blood checks and liver function tests during first 3 months. G6PD deficiency (risk of haemolytic anaemia). Lactation. C Folic-acid antagonists, hypoglycaemics. A Nausea, headache, rash, fever, loss of appetite. Blood dyscrasias, reversible oligospermia.
SALOFALK
ALSO SALOFALK RECTAL FOAM Mesalazine 1g per actuation. 14 actuations with applicators, A37.24. S Active, mild ulcerative colitis of the sigmoid colon and rectum. P Two admin. once a day at bedtime. Q Under 12 years, not recommended. D Hypersensitivity to salicylates, severe impairment of hepatic and renal function, preexisting gastric or duodenal ulcer, haemorrhagic diathesis. Pregnancy (unless benefit outweighs risk), lactation. B Monitor blood parameters and urinary status. Impaired renal function (not recommended). Caution: Impaired hepatic function, pulmonary disease (asthma), history of adverse drug reactions to preparations containing sulphasalazine. Acute intolerability reactions (discontinue). Contains aspartame. Foam contains propylene glycol and cetostearyl alcohol. C Caution: Coumarin anticoagulants, glucocorticoids, sulphonylureas, methotrexate, probenecid/sulphinpyrazone, spironolactone/ frusemide, rifampicin, azathioprine or 6mercaptopurine. A Abdominal distention (Rectal Foam).
SCHERIPROCT
Bayer Schering
0MO
Dr Falk Steroid/local anaesthetic. Prednisolone caproate
2MO Salicylate. Mesalazine 250mg. Yellow ent-ctd tab. 100, A20.78. S Management of ulcerative colitis and treatment of Crohn’s disease in patients adversely responsive to sulphasalazine. P Acute inflammation, 2 three times daily. In severe cases, dosage may be doubled for max. 8-12 weeks. Maintenance 2 three times daily. Q Under 10 years, not recommended.
2MO
ALSO SALOFALK SUPPOSITORIES Mesalazine 250mg. 30, A21.98. S Ulcerative colitis. P Acute inflammation, 2 suppos. three times daily. Severe cases, dosage may be doubled. Rowa Long term treatment and prevention of
equiv. prednisolone 0.15% and cinchocaine (HCl) 0.5%. Oint. 30g, A5.13. S Internal or external haemorrhoids, anal fissures and proctitis. V Apply twice daily; for faster relief, up to four times on day 1.
0MO ALSO SCHERIPROCT SUPPOSITORIES Prednisolone caproate equiv. prednisolone 1mg, cinchocaine (HCl) 1mg. 12, A2.43. V 1 once daily; if severe, two to three times daily on day 1. D Tuberculous, fungal and viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
ULTRAPROCT
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
Bayer Schering
19
1.5 GALLSTONES,
ALIMENTARY SYSTEM
PANCREATIC DISORDERS
White scored tabs. marked with logo one side and coded 344, 345 or 346 on reverse. 12.5mg-56, 25mg-56, A8.69; 50mg-56, A14.80. S Congestive heart failure when diuretic (frusemide 40-80mg or equiv.) is insufficient to control symptoms. P Initially 6.25mg or 12.5mg. Usual maintenance 25mg twice daily. Max. 150mg daily. Q Not recommended. D Aortic stenosis. See SPC. URSOFALK Dr Falk B Initiate under close supervision. With renal impairment, collagen vascular disease, 2MO Bile acid. Ursodeoxycholic acid 250mg. White cap. immunosuppressant therapy, monitor white cell count and urinary protein. 100, A53.02. C K+sparing diuretics, K+suppl., NSAIDs, S Dissolution of cholesterol gallstones in 1.5 GALLSTONES, PANCREATIC vasodilators, clonidine, allopurinol, procainamide, functioning gallbladders. Primary biliary cirrhosis probenecid, immunosuppressants, lithium. DISORDERS (PBC) stages I-III. A Rash, loss of taste, neutropenia, P Usually 10-12mg/kg daily taken in the thrombocytopenia, proteinuria, hypotension, ANTOX Pharma Nord evening i.e. usually 750mg daily in the evening. angioedema. Anaemia, elevated blood urea and Y Q Not recommended. D Radio-opaque calcified gallstones. Non- creatinine, elevated serum potassium and acidosis, Oral nutritional. L-Methionine 480mg, vit. C tachycardia, pruritis, flushing, vesicular or bullous functioning gallbladder. Pregnancy or women 120mg, vit. E 35mg, selenium 50mcg. Yellow oval who may become pregnant. Inflammation of small rash and photosensitivity, elevation of liver tab. 180, A79.46. enzymes in a few patients, rare cases of intestine or colon, extra hepatic cholestasis, S Chronic pancreatitis. hepatocellular injury and cholestatic jaundice. hepatitis or cirrhosis. P Up to 6 daily. Gastric irritation and abdominal pain may occur, B LFT’s prior to and during therapy. Not Q Under 16 years, at discretion of paraesthesias of the hands, serum sickness, cough, recommended for gallstones above 15mm. diam. physician. Under 5 years, not recommended. bronchospasm and lymphadenopathy. or of non-cholesterol origin. Monitor progress D Suspected or proven schizophrenia. radiologically. Secondary calcification of Renal insufficiency. Parenteral use. Pregnancy, ADENOCOR sanofi-aventis cholesterol stones may occur (related to length of lactation. 2N treatment). B Use under medical supervision. Not C Alum. hydroxide, cholestyramine or Purine nucleoside. Adenosine 6mg/2ml of 0.9% suitable as sole source of nutrition. colestipol which bind and prevent absorption. Na+ Cl sterile soln. Vial. 6 x 2ml, A31.07. CREON 10000 Solvay A Mild transient diarrhoea. S Supraventricular arrhythmias, tachycardia where there is doubt as to the 2MO 2.1 C ONGESTIVE HEART FAILURE, diagnosis. Pancreatic enzyme. Pancreatin 150mg equiv. to P Admin. by rapid IV bolus inj. when TACHYCARDIA , POST -MI lipase 10,000, amylase 8,000, protease 600 PhEur facilities exist for cardiac monitoring. Initially 3mg units. Brown/clear cap. containing gastro-resistant ACCUPRO Pfizer over 2 seconds. If necessary second dose of 6mg granules. 100, A19.33. should be given if there is no elimination of the 2MO 2MO ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. supraventricular tachycardia within 1-2 mins. A ALSO CREON 25000 Pancreatin 300mg equiv. to third dose of 12mg may be given. See SPC. lipase 25,000, amylase 18,000, protease 1000 PhEur 5mg, 10mg, 20mg: Elliptical, triangular or round Q Not recommended. units. Orange/clear cap. containing gastro-resistant resp., brown film-ctd tabs. All marked with tab. D 2nd or 3rd degree AV block and sick strength. 40mg: Reddish-brown, oval biconvex granules. 50, A23.09. sinus syndrome (except in patients with film-ctd tab. with debossing 40 on one side and 2MO functioning artificial pace maker), asthma. A PD 535 on reverse. 5mg-28, 8.38; 10mg-28, ALSO CREON 40000 Pancreatin 400mg equiv. to B Atrial fibrillation/flutter, prolonged QT A9.57; 20mg-28, A9.81; 40mg-28, A10.05. lipase 40,000, amylase 25,000, protease 1,600 S Adjunct to diuretics or cardiac glycosides interval. PhEur units. Brown/clear cap. containing gastroC Dipyridamole, xanthines, drugs tending in congestive heart failure. resistant granules. 100-A56.92. to impair cardiac conduction. P Initiate treatment under close medical S Pancreatic exocrine insufficiency. supervision with 5mg single dose increasing up to A Facial flush, dyspnoea, bronchospasm, V Initially 1 or 2 with meals. Adjust thoracic constriction, nausea. Rarely discomfort, 40mg daily given in one or two doses. Usual according to response. sweating, palpitations, hyperventilation, head maintenance, 10-20mg daily with concomitant 2MO pressure, apprehension, blurred vision, burning therapy. Treatment of severe or unstable CHF ALSO CREON FOR CHILDREN 5000 Pancreatin sensation, bradycardia, asystole, chest pain, should be initiated in hospital. 60.36mg equiv. lipase 5,000, amylase 3,600, headache, dizziness. Q 6-12 years, not recommended. protease 200 PhEur units. Round, light brown D Subaortic stenosis, history of ACE inh. gastro-resistant granules. 20g, A27.57. AMOLIN Ergha Q Initially 5000 lipase units with each feed related angioneurotic oedema. Pregnancy, 3MO or meal. Adjust according to response. Max. daily lactation. Cardioselective b-blocker. Atenolol 25mg, B Hypoglycaemia, neutropenia/ dose: 10,000 lipase units/kg/day. agranulocytosis, anaphylactoid reactions. Caution: 50mg,100mg. White film-ctd tabs. marked C23, D Hypersensitivity to porcine proteins. C24 and C25 resp. 25mg-30, A1.56; 50mg-30, Hepatic impairment, alcoholic cyrrhosis. Renal Early stages of acute pancreatitis. A2.36; 100mg-30, A3.10. insufficiency; monitor renal function before and B Monitor abdominal symptoms S Cardiac dysrhythmias. Early intervention during therapy. Contains lactose. (especially if doseq10,000 units lipase/kg/day). C Avoid tetracyclines. Caution: b-blockers, of myocardial infarction. Pregnancy, lactation (only if clearly necessary). P 50-100mg daily. methyldopa, diuretics, lithium, agents increasing A GI disorders, skin and SC tissue allergic Q Not recommended. serum K+, antidiabetics, surgery/anaesthesia. or hypersensitivity reactions. D See 2.4, b-blockers Drug Presc. Notes. A Pharyngitis, insomnia, hyperkalaemia, ROWACHOL Rowa paraesthesia, dyspnoea, abdominal pains, back ARYTHMOL Abbott pain, myalgia, asthenia. 2O
0MO
Steroid/local anaesthetic/antihistamine. Fluocortolone pivalate 0.092%, fluocortolone hexanoate 0.095%, cinchocaine (HCl) 0.5%. Oint. 30g, A5.30. S Internal or external haemorrhoids, anal fissures and proctitis. P Apply twice daily; for faster relief, up to four times on day 1. D Tuberculous, fungal and viral infections. 1st trimester of pregnancy. B Avoid prolonged use. Pregnancy, lactation. A Systemic corticosteroid effects.
Essential oils. Menthol 32mg, menthone 6mg, essential oils a-b-pinenes 17mg, camphene 5mg, cineole 2mg, borneol 5mg. Green ent-ctd oval gelatin cap. 50, A4.76.
20
S Hepato-biliary disorders incl. the dissolution of radiolucent gallstones in the functioning gallbladder. P 1-2 caps three times daily before meals. Q 6 to 14 years: 1 cap three times daily before meals. Under 6 years, not recommended. D Pregnancy, lactation. B Oral contraceptives. Oral anticoagulants. C Oral contraceptives. Oral anticoagulants.
ACEOMEL
Clonmel
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg.
A7.73;
2MO Class I antiarrhythmic. Propafenone (HCl) 150mg, 300mg. White film-ctd tabs. 150mg-90, A23.19; 300mg-60, A23.19.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
2.1
Uncoated tabs debossed with strength on 1 side. Light yellow biconvex cap-shaped tab. (10mg); light peach biconvex cap-shaped tab. (20mg). Cardioselective b-blocker. Atenolol 25mg, 50mg, 10mg-28, A7.87; 20mg-28, A9.32. 100mg. White, white, orange film-ctd tabs. S Symptomatic cardiac insufficiency. Shortmarked AT/25, AT/50, AT/100, resp. All marked term treatment (6 weeks) of haemodynamically with maker’s symbol. 25mg-28, A2.49; 50mg-28, stable patients in the 24 hours following acute MI. A3.77; 100mg-28, A5.38. P Heart failure: Initially 2.5mg once a day S Cardiac arrhythmias. Long-term under medical supervision. Increase to highest prophylaxis after recovery from acute MI. Angina dose tolerated, up to max 35mg once a day by pectoris. Essential hypertension. increments of not more than 10mg, at intervals r P Arrythmias: 50-100mg daily. Prophylaxis 2 weeks. Acute MI: Do not start if systolic BP after recovery from MI: 100mg daily. Hypertension: Q100mmHg. Initially (3 days after infarct), 5mg 50mg daily increasing to 100mg daily if required. orally, followed by 5mg after 24 hours, 10mg after Allow time to achieve full effects (1-2 weeks) 48 hours and 10mg/day thereafter. Low systolic BP before determining need to increase to 100mg (R120mmHg) at start of treatment or within first daily. Angina: 100mg daily as a single dose or as 3 days of infarct: Initially, 2.5mg orally. 50mg twice daily. Maintenance, 10mg once a day. Reassess after 6 Q Not recommended. weeks. If hypotension occurs (systolic BP ATACAND AstraZeneca D See 2.4, b-blockers Drug Presc. Notes. R100mmHg), 5mg with temporary decrease to 2MO 2.5mg if necessary; withdraw if prolonged. Renal ATENOMEL Clonmel impairment, ccQ10ml/min, initially 2.5mg; Angiotensin II antagonist. Candesartan cilexetil 3 M O 2mg, 4mg, 8mg, 16mg. White, white, light pink 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ Cardioselective b-blocker. Atenolol 25mg, 50mg, and pink tabs. resp. 4, 8 and 16mg tabs scored. min, initially 5-10mg/day. 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; 100mg. White tab. marked C23, C24, C25. 50 and Q Not recommended. 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; 16mg-28, A24.74. D History of angioedema associated with S Treatment of heart failure and impaired 100mg-30, A5.01. prior ACE inhibitor treatment, hereditary or S Cardiac arrhythmias, early intervention left ventricle systolic function as add-on therapy to idiopathic angioedema, pregnancy, lactation. in acute MI. ACE inhibitors or when ACE inhibitors are not B Caution: Acute MI (renal dysfunction, P 50-100mg daily. tolerated. do not use), mitral stenosis and LV outflow Q Not recommended. P Initially 4mg once daily. Titration to obstruction, aortal stenosis, hypertrophic D See 2.4, b-blockers Drug Presc. Notes. target dose 32mg once daily done by doubling myocardiopathy, bilateral renal artery stenosis or dose at intervals of min. 2 weeks. artery stenosis in a single kidney (strict supervision BELLISIN Ranbaxy Q Under 18 years, not recommended. with low doses; careful dose adjustment), preD Severe hepatic impairment, cholestasis. 2MO existing renal impairment (monitor blood K+ and Pregnancy, lactation. ACE inhibitor. Lisinopril (as dihydrate)10mg, 20mg. creatinine concentrations), major surgery, B Correct volume/salt depletion before starting therapy. Severe or end-stage renal PRESCRIBING NOTES HEART FAILURE (HF) impairment, renal artery stenosis, aortic or mitral HF is diagnosed in patients with known/suspected cardiac disorder who present with dyspnoea, fatigue, stenosis, obstructive hypertrophic cardiomyopathy. oedema. Primary hyperaldosteronism (not recommended). HF arises from primary myocardial disease, such as dilated cardiomyopathy, but it occurs most frequently Monitor serum K+ and renal function. Contain secondary to coronary artery disease. Valvular heart disease and arrhythmias, e.g. uncontrolled atrial lactose. fibrillation, are other common causes of HF. HF is graded either as mild, moderate or severe or using the + + C Caution: K sparing diuretics, K suppl., New York Heart Association reference grades I, II, III, IV. When investigating HF an echocardiogram is the heparin, lithium, antihypertensives, indomethacin. most useful tool. An ECG is seldom normal but not diagnostically abnormal in impaired hearts while a A Hypotension, hyperkalaemia, renal chest x-ray is not usually helpful in diagnosing the aetiology but may show an enlarged heart and changes impairment, increases in creatinine, urea and K+. in the lung fields. Other investigations should include baseline blood tests, such as full blood count (to S Ventricular and supraventricular extrasystoles and tachycardias, tachyarrhythmias. P Adjust to individual requirements. Q Not recommended. D Manifest HF, sick sinus syndrome, complete heart block, cardiac shock, severe bradycardia, 3 months post-MI, marked hypotension, electrolyte imbalance, severe obstructive pulmonary disease, myasthenia gravis, known hypersensitivity. B Initiate under cardiological surveillance. C Other anti-arrhythmic agents, bblockers, digitalis, local anaesthetics, TCAs, disipramine, cyclosporin, digoxin, cimetidine, quinidine, phenobarbital, rifampicin, oral anticoagulants. A Nausea, blurred vision, vertigo, proarrythmic events, GI disorders.
ATECOR
Rowex
3MO Cardioselective b -blocker. Atenolol 25mg, 50mg, 100mg. White scored film-ctd tabs. 25mg-30, A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, A5.77; 100, A18.67. S Cardiac arrhythmias. Early intervention of acute MI. P 50-100mg twice daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
ATENI
Gerard
3MO Cardioselective b-blocker. Atenolol 50mg, 100mg white tabs. Both marked AT and strength one side, G on reverse. 50mg-28, A4.16; 100mg-28, A5.38. S Long-term prophylaxis from MI. P Myocardial infarction: Early intervention; 50mg orally 15 min after IV inf. followed by 50mg orally 12 hr after IV inf. then 100mg orally 12 hr later. Late intervention; 100mg daily. See SPC. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
ATENOGEN
Antigen
3MO
exclude anaemia), urea and electrolytes, creatinine and blood glucose. Drug Treatment Lifestyle advice on diet, weight loss and salt restriction should be advised and tightly implemented in more severe cases of HF. Fluid restriction is often necessary in advanced HF. Exercise should be encouraged to improve efficiency of the circulation. Bed rest is indicated only in people with acute right or left ventricular failure and even then for a limited period of time only. Alcohol intake should be minimal. ACE inhibitors produce clinical benefit in all stages of HF improving both quality and life expectancy. They are recommended in all cases of symptomatic HF and in case of asymptomatic LV dysfunction. ACE inhibitors can restore the potassium loss caused by moderate doses of loop diuretics. Trials have shown that ACE inhibitors have a protective effect against myocardial infarction, unstable angina, and cardiac death in patients with either symptomatic or asymptomatic HF. Diuretics: Thiazide and loop diuretics have a synergistic effect and can be used in combination in more severe cases of HF. Both classes can cause hypokalaemia so electrolyte monitoring is essential. There are many combination products which include a loop diuretic and a potassium-sparing diuretic, e.g. coamilofruse (frusemide and amiloride). Spironolactone produces a more powerful diuresis than amiloride, but has a higher side effect profile. Beta-blockers should be considered in all patients with NYHA class II to IV with reduced LVEF on standard treatment including diuretics and ACE inhibitors. They are also recommended, in addition to ACEinhibitors, in patients with LV systolic dysfunction (even if asymptomatic) following an AMI. Only bisoprolol, carvedilol, metoprolol succinate and nebivolol can be recommended. Nebivolol has recently been approved in elderly patients > 70 years with mild and moderate CHF in addition to standard therapies. Aldosterone receptor antagonists are recommended in addition to ACE inhibitors, beta-blockers and diuretics in patients with advanced HF (NYHA III/IV), or in combination with ACE inhibitors and betablockers in patients with a recent MI, LV systolic dysfunction and signs of HF or diabetes. Angiotensin II receptor blockers (ARBs) have similar efficacy as ACE inhibitors and can be used as an alternative in patients intolerant to ACE inhibitors. ARBs can also be used in combination with ACE inhibitors in CHF patients who remain symptomatic. Other drugs used in the management of HF include digoxin (especially useful in atrial fibrillation) and hydralazine and nitrates in combination (when ACE inhibitors and ARBs are not tolerated). References available on request. Revision date: January 2006.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
21
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
function prior to and during treatment. Caution: Impaired liver function, volume- and saltdepletion, anaesthesia. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, Hb content and platelet count, hyperkalaemia. Avoid haemodialysis using high flux membranes and LDL apheresis with dextran sulphate. C Caution: Diuretics or other antihypertensives, K+ sparing diuretics, K+ supplements, antidiabetics, NSAIDs, lithium, allopurinol, immunosuppressants and other substances that may change the blood picture. A Hypersensitivity reactions, eosinophilia, raised antinuclear antibodies titres, sleep disorders, depressed mood, anxiety, dizziness, disturbances of balance, nervousness, restlessness, tremor, confusion, loss of appetite, paraesthesiae, BELLRAMIL Ranbaxy conjunctivitis, symptomatic hypotension, syncope, MI or cerebrovascular accident possibly secondary 2MO to severe hypotension, chest pain, palpitations, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 rhythm disturbances, angina pectoris, vasculitis, hard cap. with resp. yellow, orange, maroon or dry tickling cough, rhinitis, sinusitis, bronchitis, blue cap /white body, imprinted with R on cap bronchospasm, GI disorders, cutaneous and and strength on body. Contain white to off-white mucosal reactions, muscle cramps, muscle and joint granular powder. 2.5mg-30, A5.50; 5mg-30, pains, impaired renal function, impotence, A7.10; 10mg-30, A9.60. decreased libido, taste change/reduction/loss, fever S To reduce risk of MI, stroke, cardiovascular death or need for revascularisation headache, fatigue, malaise, increases in blood urea, nitrogen and serum creatinine, decreased procedures in patients of 55 years or more with serum Na+, increased serum K+. clinical evidence of cardiovascular disease (previous MI, unstable angina or multivessel CABG BETALOC AstraZeneca or multivessel PTCA), stroke or peripheral vascular 3MO disease or with one or more of the following clinical findings: Hypertension (systolic Cardioselective b-blocker. Metoprolol tartrate BPq160mmHg or diastolic BPq90mmHg); high 50mg white tab. scored and marked A/BB; 100mg total cholesterol q5.2mmol/L); low HDL white tab. scored and marked A/ME. 50mg-100, A2.11; 100mg-100, A3.91. (Q0.9mmol/L); current smoker; known microalbuminuria; clinical evidence of previous S Cardiac arrhythmias. vascular disease. Congestive HF as adjunctive P 50mg two or three times daily; max. therapy to diuretics with or without glycosides. 300mg daily. Reduces mortality when given to patients Q Not recommended. surviving acute MI with clinical evidence of HF. 3N P Reducing risk of MI, stroke or ALSO BETALOC INJECTION Metoprolol tartrate cardiovascular death and/or need for 1mg/ml. 5ml amp. 5, A3.03. revascularisation procedures: Initially, 2.5mg once S Maintenance therapy in myocardial daily. Double dose after 1 week, after 3 further infarction. Supraventricular arrhythmias. weeks increase to 10mg. Maintenance: 10mg once D See 2.4, b-blockers Drug Presc. Notes. daily. Congestive HF: Patients stabilised on diuretic therapy, 1.25mg once daily. If needed, double BIOCARD Niche dose at 1-2 week intervals. If daily dose q2.5mg 3MO required, take as a single dose or as 2 divided a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, doses. Max daily dose: 10mg. Post MI: Initiate in 25mg. Round bevel edged tabs. (3.125mg), scored hospital between day 3 and day 10 following MI. on one side (25mg). Oval tab., marked S2 on one Starting dose, 2.5mg twice daily during 2 days. side (6.25mg scored) or S3 on one side (12.5mg May be increased to 5mg twice a day after 1-3 scored). All slightly biconvex, white. 3.125mg-28, days interval. If initial 2.5mg not tolerated, 1.25mg A 5.09; 6.25mg-28, A6.23; 12.5mg-28, A7.45; twice a day should be given for 2 days before 25mg-28, A8.32. increasing to 2.5mg and 5mg twice daily. If dose S Symptomatic CHF (NYHA Class II and III) cannot be increased to 2.5mg twice daily, as adjunct to standard therapy. withdraw treatment. Max daily dose 10mg. P Titrate dose individually and monitore Maintenance: 2.5mg-5mg twice daily. Renal during up-titration. Initially, 3.125mg twice daily impairment: ccQ30ml/min, initially 1.25mg once for 2 weeks. If tolerated, titrate at min. 2 week daily, max 5mg once daily; ccQ10ml/min, 1.25mg intervals to 6.25mg twice daily, then to 12.5mg once daily, maintenance 2.5mg once a day max. twice daily, then 25mg twice daily. Max. 25mg Hepatic impairment: Initially, 1.25mg under close twice daily in patients under 85kg, or 50mg twice medical supervision. daily in patients over 85kg. R Caution Q Under 18 years, not recommended. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. D History of angioneurotic oedema, NYHA class IV decompensated HF requiring IV haemodynamically relevant renal artery stenosis inotropic support, liver dysfunction. (bilateral or unilateral in single kidney). Aortic or mitral valve stenosis or outflow obstruction. BISOP Rowex Hypotensive or haemodynamically unstable 3MO patients. Pregnancy, lactation. B Renal impairment risk; assess renal Cardioselective b-blocker. Bisoprolol fumarate
anaesthesia, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately), anaphylactoid reactions in haemodialysis patients or during desensitisation treatment, acute renal insufficiency in patients with HF (usually reversible), hepatic insufficiency, neutropenia/ agranulocytosis, cough. C Not recommended: Lithium. Caution: Diuretics, K+ sparing diuretics, K+ supplements, salt substitutes containing K+, NSAIDs (incl. acetylsalicylic acid r 3g/day), other antihypertensives, certain anaesthetics, tricyclic antidepressants and antipsychotic agents, sympathicomimetics, anti-diabetics. A Dizziness, headache, orthostatic effects (incl. hypotension), diarrhoea, vomiting, renal dysfunction, impotence.
22
CIRCULATORY SYSTEM 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. Round film-ctd tablet encoded BIS and strength on one side. White (2.5mg), yellow-white with a score (3.75mg), yellow with a cross score (5mg), yellow with a score (7.5mg), apricot with a cross score (10mg). 1.25mg-28, A5.58; 2.5mg-28, A5.17; 3.75mg-28, A6.38; 5mg-28, A5.34;7.5mg-28, A7.74;10mg-28, A6.01. S Stable chronic HF with reduced systolic LV function in addition to ACE inhibitors and diuretics, and optionally cardiac glycosides. P Should be taken with liquid (not chewed), in the morning. Requires titration, monitoring vital signs closely, increasing dose if well tolerated: 10mg (max) once daily for maintenance. If max dose not well tolerated, consider gradual dose reduction. Lower dose or consider gradual discontinuation if transient worsening of HF, hypotension, bradycardia occur. Q Not recommended. D Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. Cardiogenic shock. AV block of 2nd or 3rd degree (without a pacemaker). Sick sinus syndrome. Sinoatrial block. Bradycardia (Q 60 beats/min) before start of therapy. Hypotension (systolic BP Q 100mmHg). Severe bronchial asthma or severe COPD. Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome. Untreated phaeochromocytoma. Metabolic acidosis. Pregnancy (unless necessary), lactation. B Regular monitoring required. Withdraw gradually. Caution: Bronchospasm, diabetes mellitus with large fluctuations in blood glucose (hypoglycaemia symptoms can be masked), strict fasting, ongoing desensitisation therapy, AV block of 1st degree, Prinzmetal’s angina, peripheral arterial occlusive disease, general anaesthesia. In bronchial asthma or other COPD, bronchodilating therapy should be given concomitantly. Psoriasis: Assess risk/benefit. Phaeochromocytoma: Do not admin. until after a-receptor blockade. Symptoms of thyrotoxicosis may be masked. Contains lactose. Driving/operating machinery ability (at start of treatment, with alcohol). C Contra: Floctafenin, sultopride. Not recommended: Ca++ antagonists (verapamil type and diltiazem type), class I antiarrhythmics, centrally acting antihypertensives. Caution: Ca++ (dihydropyridine type (e.g. felodipine, amlodipine), class-III antiarrhythmics (e.g. amiodarone), topical b-blocking agents (e.g. eye drops for glaucoma treatment), parasympathomimetics, insulin and oral antidiabetics, anaesthetic agents, digitalis glycosides, NSAIDs, b-sympathomimetics that
Anti-Doping Information
s This medicinal product contains substance(s) prohibited for use in specific sports only (as listed in WADA Prohibited List 2010). Athletes requesting to use this product in these specific sports are required to apply for a TUE.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
P CHF: Initially, 1.25mg once daily; may be doubled at intervals of 1-2 weeks. Dose r2.5mg may be taken as single dose or two divided doses. Max. 10mg daily. Post MI: Start treatment in hospital between day 3 and 10 post MI. Initially, 2.5mg twice a day, increased to 5mg twice a day after 2 days. If 2.5mg not tolerated, start with 1.25mg twice a day for 2 days; withdraw treatment if cannot be increased. Maintenance: 2.5-5mg twice a day. Prevention of cardiovascular BLOPRESS Takeda events: Initially 2.5mg once daily. If tolerated, double after 1 week and after another 3 weeks 2MO up to 10mg daily (usual maintenance dose). Angiotensin II antagonist. Candesartan cilexetil Q Not recommended. 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white tab. 4mg: Round white tab. with single score line D History of angioneurotic oedema relating to previous ACE inhibitor treatment. on both sides. 8mg: Round pale pink tab. with single score line on both sides. 16mg: Round light Pregnancy, lactation. Use in children. pink tab. with one convex side embossed with 16 B Aortic stenosis, outflow obstruction (not recommended). Assess renal function prior to and and one scored flat side. 32mg: Round light pink during treatment. Impaired renal/liver function; tab. with convex sides, debossed 32 on one side reduce dose and monitor closely. Haemodialysis and scored on the other. 2mg-7, A1.81; 2mg-28, using high-flux membranes (avoid). Correct A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, volume/salt depletion before initiating therapy. 15.81; 16mg-28, A19.22; 32mg-28, A24.63. Collagen vascular disease; monitor white blood S Heart failure and left ventricle systolic cell counts and protein levels in urine. dysfunction (LVEF R40%) as add-on therapy to Hyperkalaemia, angioneurotic oedema have been ACE-inhibitors or when ACE-inhibitors not reported rarely. Surgery/anaesthesia. Driving or tolerated. operating machines. P Initially 4mg once daily. Titrate up to C Caution: Antidiabetics, NSAIDs. 32mg once daily by doubling dose at intervals of A Nausea, dizziness and headache, GI at least 2 weeks. disturbances, cough, skin/mucosal reactions. Q Safety and efficacy not established. D Pregnancy, lactation. Severe hepatic BYZESTRA Ergha impairment and/or cholestasis. 2MO B Not recommended: Primary hyperaldosteronism. Caution: Haemodynamically Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. relevant aortic mitral valve stenosis, obstructive White tabs marked LSN followed by strength. hypertrophic cardiomyopathy, severe CHF, 2.5mg-28, A3.13; 5mg-28, A4.41; 10mg-28, A5.44; underlying renal disease (incl. renal artery 20mg-28, A6.25. stenosis), haemodialysis (carefully titrate with S Heart failure (HF) as additive therapy to thorough monitoring of BP), anaesthesia and non-K+-sparing diuretics and where appropriate, surgery. Monitor renal function, serum K+ and digitalis. Acute MI in haemodynamically stable patients (SBPq100mmHg) without significant creatinine levels (HF, elderly, renal impairment, renal dysfunction as suppl. to standard therapy. concomitant ACE inhibitor). Hypotension may P HF: 2.5mg in the morning; titrated in occur. Contains lactose. increments of 2.5mg at intervals of 2-4 weeks; C Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other maintenance, 5-20mg once daily; max. 35mg daily. + + MI: Initiate within 24 hrs of symptom onset in antihypertensives. K -sparing diuretics, K haemodynamically stable patients. Initially, 5mg supplements, salt substitutes containing K+, or daily, then 5mg after 24 hrs, 10mg after 48 hrs other medicinal products that may increase K+ and thereafter 10mg once daily. Continue for 6 levels, lithium. weeks. Min. maintenance dose, 5mg daily. A Hyperkalaemia, hypotension, renal Moderate renal impairment: As per elderly. impairment. R Initially, 2.5mg in the morning; BREVIBLOC Baxter maintenance usually 5-10mg daily; max. 20mg daily. 3N Q Not recommended. Cardioselective b-blocker. Esmolol (HCl) 10mg/ml, D Angioneurotic oedema, severe renal 250mg/ml. Soln. 10mg/ml vial-5 x 10ml, A40.08; impairment, aortic or mitral valve stenosis, 250mg/ml amp.-1 x 10ml, A89.55. hypertrophic cardiomyopathy, haemodynamically D See 2.4, b-blockers Drug Presc. Notes. unstable patients after acute MI, SBPR100mmHg. Lactation, pregnancy. Permanent haemodialysis, BYTRITE Helsinn Birex cardiogenic shock. 2MO B Initiate therapy/adjust dose in hospital ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, in: High risk for severe acute hypotension, e.g. vol/ 10mg. Opaque hard gelatin caps. Yellow, light salt depletion, pre-existing hypotension, orange, pink and blue cap with white bodies renovascular hypertension, renal artery stenosis, printed 93 and 7209, 7210, 7211, 7212 resp. unstable cardiac failure, renal impairment, high1.25mg-28, A2.48; 2.5mg-28, A3.53; 5mg-28, dose vasodilator therapy, patients r70 years, A4.94; 10mg-28, A6.73. cerebrovascular disease, malignant hypertension. Discontinue or reduce diuretic therapy for 2-3 days S Congestive heart failure (CHF), as before treatment and start with 2.5mg daily. adjunctive therapy to diuretics with or without Primary hyperaldesteronism (not recommended). cardiac glycosides. Acute MI. Patients with Hypertrophic cardiomyopathy, surgery; caution. increased cardiovascular risk of MI, stroke or C Caution: K+-sparing and other diuretics, cardiovascular death taking standard therapy or K+ suppls, NaCl, antihypertensives, analgesics, antitype 2 diabetic patients at risk. activate both b and a-adrenoreceptors (e.g. noradrenaline, adrenaline), antihypertensives, tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAOB inhibitors). A Bradycardia, worsening of heart failure, dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, asthenia, fatigue.
2.1
inflammatory agents, lithium, alcohol, anaesthetics/ narcotics/ hypnotics, sympathomimetics, oral antidiabetics, antacids, NSAIDs. A Hypotension, headache, tiredness, dry cough, sore throat, bronchitis, nausea, rash, angioneurotic oedema, hyperkalaemia.
CAPOTEN
BMS
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Mottled white cap. shaped scored tab. marked SQUIBB 450, mottled white quarter scored square tab. coded 452 and SQUIBB, mottled white oval tab. coded 482 and SQUIBB. 12.5mg-56, A7.99; 25mg-56, A9.10; 84, A24.72; 50mg-56, A15.52; 84, A42.12. S Congestive heart failure when diuretic (frusemide 40-80mg daily or equiv.) is insufficient to control symptoms. Post MI with left ventricular dysfunction. P CHF: initially 6.25mg; usual maintenance, 25-50mg twice daily. Max. 150mg daily. See SPC. Post MI: initially 6.25mg. Titrate slowly to 150mg daily in divided doses. Initiate therapy 3 days after MI. Q Contact manufacturer. D Aortic stenosis. Renal impairment. Pregnancy, lactation. See SPC. B Initiate therapy under close supervision, continue diuretics and if appropriate, digitalis concurrently. With renal impairment, collagen vascular disease, immunosuppressant therapy or leukopenic drugs, monitor white cell count and urinary protein. Contains lactose. C K+sparing diuretics or K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, probenecid, immunosuppressants. A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria.
CAPTOR
Rowex
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (12.5mg); white tabs. cloverleaf form with facet and quarter scored both sides (25mg, 50mg). 12.5mg-60, A8.54; 100, A14.25; 25mg-60, A9.73; 100-A16.22; 50mg-60, A16.60; 100, A27.67. S Chronic heart failure with reduction of systolic ventricular function, in combination with diuretics and, if appropriate, digitalis and bblockers. MI: Clinically stable patients within 1st 24 hours of an infarction; long term prevention in clinically stable patients with asymptomatic left ventricular dysfunction. Macroproteinuric diabetic nephropathy in patients with type I diabetes. P HF: Initially 6.25mg-12.5mg twice or three times daily; titrate by at least two week intervals to maintenance 75-150mg/day; max.150mg daily. Post-MI: Short term, initiate therapy with 6.25mg as soon as possible in patients with stable haemodynamics; 12 hrs later 12.5mg; next days 100mg/day in two admins. for 4 weeks. Chronic, initiate therapy 3-16 days after MI with 6.25mg followed by 12.5mg 3 times daily for 2 days and then 25mg 3 times daily; long-term treatment, 75-150mg daily in two or three doses. Renal impairment: See SPC. R Initially 6.25mg twice daily. Q Initially 0.3mg/kg, or 0.15mg/kg in infants or renal dysfunction. Generally 3 times a day. D Angioneurotic oedema. Pregnancy,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
23
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
lactation. B Renal impairment, renal artery stenosis, LV valvular and outflow tract obstruction, collagen vascular disease, patients at risk for hyperkalaemia, diabetes, hepatic impairment, anaesthesia. Neutropenia/ agranulocytosis, proteinuria. Contains lactose. C K+sparing diuretics, K+suppl., diuretics, other anti hypertensive agents, lithium, TCAs, allopurinol, procainamide, cytostatic or immunossupressive drugs, NSAIDs, sympathomimetics, antidiabetics. A Pruritus, rash, alopecia, dry cough, loss of taste, dizziness, sleep disorders, GI disorders.
CARDICOR
Daiichi Sankyo/Merck Serono
3MO Cardioselective b-blocker. Bisoprolol fumarate 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. White, white, off white, white-yellow, light yellow, light orange film ctd tabs. 1.25mg round, all others heart shaped and scored. 1.25mg-28, A 3.58; 2.5mg-28, A3.31; 3.75mg-28, A4.09; 5mg-28, A4.28; 7.5mg-28, A4.95; 10mg-28, A5.48. S Stable chronic HF with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. P Patients should be stable when initiating treatment. If tolerated, titrate gradually to 10mg once daily max. Initially 1.25mg once daily for 1 week, 2.5mg once daily for a further week, 3.75mg once daily for a further week, 5mg once daily for the following 4 weeks, 7.5mg once daily for the following 4 weeks, 10mg once daily for maintenance therapy. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. B Require exp. in management of chronic HF. Observe patient for 4 hours after start of treatment.
CIBACEN
Meda
2MO ACE inhibitor. Benazepril (HCl) 5mg cap-shaped pale yellow film-ctd tab scored both sides and marked CG one side and LV on reverse. 10mg dark yellow film-ctd tab marked CG one side and HO on reverse. 5mg-28, A9.33; 10mg-28, A12.44. S Adjunctive therapy in patients with congestive heart failure. P Initially 2.5mg once daily. Titrate to max. 20mg once daily at 2-4 week intervals. Q Not recommended. D Pregnancy, lactation. History of angioedema. B Salt and/or volume depletion. Renal artery stenosis, renal impairment, surgery, anaethesia, CHF. C Other anithypertensives, K+suppl., K+sparing diuretics, lithium. A Headache, upper respiratory tract symptoms, dizziness, fatigue, musculoskelatal pain, cough, rhinitis, nausea, diarrhoea, rash.
Parkinson-White syndrome. Atrial flutter and fibrillation where other drugs cannot be used. All types of paroxysmal tachyarrhythmias where other drugs cannot be used. Prevention of ventricular arrhythmias in high-risk patients following MI or in patients with clinical signs of CHF and/or LVEF Q 40% receiving appropriate cardiac failure treatment incl. ACE-inhibitors (under hospital/ specialist supervision). P 200mg three times daily for 1 week then 200mg twice daily for 1 week. Maintain on min. effective dose, usually 200mg daily. R Use minimum dose; monitor regularly. D Sinus bradycardia, sino-atrial heart block. Evidence or history of thyroid dysfunction. Pregnancy (except exceptional circumstances), lactation. B In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, only use in conjunction with a pacemaker. Severe bradycardia and conduction disturbances may occur at too high doses (discontinue). May occur: Marked heart rate reduction (elderly); 2nd or 3rd degree A-V block, sino-atrial block, or bifascicular block (discontinue); onset of new arrhythmias / worsening of treated arrhythmias (sometimes fatal), hyperthyroidism (withdraw); peripheral sensorimotor neuropathy and/or myopathy; hypothyroidism or hyperthyroidism (monitor usTSH before starting treatment). Monitor: Liver function, pulmonary function (particularly if pulmonary toxicity suspected). If blurred or decreased vision occurs, perform complete ophthalmologic examination. Caution: long-term therapy. Instruct patients to avoid sun exposure. Contains lactose and iodine. C Contra: Drugs which prolong QT interval. Not recommended: b-blockers, diltiazem, verapamil, stimulant laxatives, fluoroquinolones. Caution: Oral anticoagulants, digoxin, phenytoin, diuretics, systemic corticosteroids, tetracosactride, intravenous amphotericin, general anaesthesia, high dose oxygen therapy, flecainide, drugs metabolised by CYP3A4 (fentanyl, ciclosporin, simvastatin, atorvastatin and lovastatin, tacrolimus, sildenafil, midazolam, triazolam, dihydroergotamine, ergotamine). Avoid grapefruit juice. Advise patients to moderate alcohol levels. A Bradycardia, hypothyroidism, hyperthyroidism, corneal microdeposits, GI disorders, increased serum transaminases, acute liver disorders, extrapyramidal tremor, nightmares, sleep disorders, pulmonary toxicity, photosensitivity, pigmentation on light exposed skin.
COVERSYL ARGININE
Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.
COZAAR
MSD
2MO Angiotensin II antagonist. Losartan (K+) 12.5mg, 50mg, 100mg. Blue oval-shaped film-ctd tab. marked 11, white film-ctd scored tab. marked 952. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg-28, A30.80.
2MO
ALSO COZAAR ORAL SUSPENSION Losartan K+, 2.5mg/ml (reconstituted susp.). White to off-white powder and cloudy, colorless solvent for oral susp. 500mg/200ml, A50. S Chronic HF (patients r 60 years), when treatment with ACE inhibitors not suitable due to incompatibility (esp. cough) or contraindication. Patients with HF stabilised with an ACE inhibitor should not be switched to losartan. Patients should have LV ejection fraction R40% and be clinically stable and on established treatment regimen for chronic HF. P Initially 12.5mg once daily. Titrate at weekly intervals to maintenance of 50mg once daily. Q Not recommended. D Severe hepatic impairment. Pregnancy. B History of angiooedema (closely monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc. Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF, HF and symptomatic life threatening cardiac arrhythmias. Lactation (not recommended). Tabs contain lactose. C Rifampicin, fluconazole, NSAID, K+ sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, Servier asthenia/fatigue, hyperkalaemia, hypoglycaemia.
2MO
ACE inhibitor. Perindopril arginine 5mg. Lightgreen, rod-shaped scored film-ctd tab with a symbol. 5mg-30, A14.12. S Symptomatic heart failure. P Initially 2.5mg in the morning (under medical supervision). If tolerated, can increase to 5mg after 2 weeks. Severe HF: Initiate under careful supervision. Renal insufficiency, 2.5mg according to creatinine clearance. CORDARONE X sanofi-aventis Q Not recommended. 2MO D ACE inhibitor hypersensitivity. History of Class III antiarrhythmic. Amiodarone (HCl) 100mg, angioneurotic oedema (previous ACE treatment), 200mg. Round, white tab. with breakline one side, hereditary or idiopathic angioedema. Pregnancy, imprinted 100 or 200 on the other. 100mg-28, lactation. A6.03; 200mg-28, A9.87. B Symptomatic hypotension may occur in S Tachyarrhythmias associated with Wolff- patients with salt or volume depletion. Caution:
24
CIRCULATORY SYSTEM
COZATAN
Clonmel
2MO Angiotensin II antagonist. Losartan (K+), 50mg, 100mg. Resp. round or oblong biconvex white film-ctd tab. with breaking notch on both sides. Can be divided into equal quarters or halves. 50mg-28, A9.54; 100mg-28, A16.03. S Cronic HF (r60 years), when treatment with ACE inhibitors not suitable due to incompatibility or contraindication. Patients with HF stabilised with an ACE inhibitor should not be switched to losartan. Patients should have a LV ejection fraction R40% and be stabilised under treatment of chronic HF. Reduction in stroke risk in hypertensive patients with LV hypertrophy documented by ECG.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
P HF: Initially, 12.5mg once daily. Titrate at weekly intervals to 50mg once daily maintenance dose, as tolerated by patient. Stroke risk reduction: Initially, 50mg once daily. Based on BP response, add low dose of HCTZ and/or increase Cozatan to 100mg once daily. Intravascular volume depletion: Consider 25mg once daily initially. Hepatic impairment: Consider a lower dose. R As per adults. q75 years, consider initiating therapy with 25mg. D Severe hepatic impairment. Pregnancy, lactation. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension (correct prior to initiating or use lower starting dose). Monitor K+ and cc. Caution: Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Monitor renal function regularly. No sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF (NYHA class IV), HF and symptomatic life threatening cardiac arrhythmias. Contains lactose. C Not recommended: K+ sparing diuretics, K+ supplements or salts, ACE inhibitors. Caution: Other antihypertensives, TCAs, antipsychotics, baclofen, amifostine, fluconazole, rifampicin, lithium, NSAIDs.
DIOVAN
Novartis
2MO Angiotensin II antagonist. Valsartan 40mg, 80mg, 160mg. Yellow, pale red, grey-orange film-ctd scored tabs. marked DO, D/V, and DX/DX resp. on one side and NVR on reverse. 40mg-28, A15.70; 80mg-28, A17.80; 160mg-28, A23.02. S Clinically stable patients with symptomatic heart failure (HF) or asymptomatic left ventricular systolic dysfunction after recent (12 hrs-10 days) MI. Symptomatic HF when ACE inhibitors could not be used, or as add-on therapy to ACE inhibitors when b-blockers could not be used. P HF: Initially 40mg twice daily; uptitration to 80mg and 160mg twice daily (max. dose) at min. 2 week intervals to highest dose tolerated. Post-MI: After 12hrs, initially 20mg twice daily; uptitration to target max. dose of 160mg twice daily. Use with ACE inhibitors in post-MI not recommended. Mild to moderate hepatic impairment without cholestasis: Max. 80mg daily. Q Under 18 years, not recommended. D Pregnancy, lactation. Severe hepatic impairment, biliary cirrhosis and cholestasis, severe renal impairment (cc Q10ml/min.), patients undergoing dialysis. Primary aldosteronism. B Correct volume/salt depletion before starting therapy. HF, recent MI; reduction in BP. Renal artery stenosis, kidney transplantation, hepatic impairment, obstructive hypertrophic cardiomyopathy, aortic and mitral valve stenosis. C Caution: K+suppl., K+ sparing diuretics, antihypertensives, lithium. A Postural dizziness, orthostatic hypotension, renal failure/impairment.
DOPACARD
Cephalon
0JN Catecholamine. Dopexamine (HCl) 50mg/5ml. Amp. Concentrate for sln for infusion. 10 x 5ml,
HEART FAILURE, TACHYCARDIA, POST-MI
2.1
A377.93. S Short term IV admin. to patients who require peripheral or renal vasodilation and inotropic therapy in the treatment of heart failure or cardiac surgery. P Admin. by IV inf. diluted before use. See SPC. Q Not recommended. D Aortic stenosis, cardiomyopathy, phaeochromocytoma, thrombocytopenia. Pregnancy, lactation. MAOI treatment. B Cardiogenic shock, myocardial infarction, angina, hypokalaemia, hyperglycaemia. Use in specialised units with facilities for patient surveillance and monitoring. Benign arrhythmias. C Sympathomimetics, b -blockers, MAOIs. See SPC. A Tachycardia. Nausea, vomiting, tremor.
necessary. Inj. rate should not exceed 50mg per min. Q Not recommended. D Sinus bradycardia, sino-atrial block, 2nd/ 3rd degree A-V block, Adams-Stokes syndrome. B Severe cardiotoxic reactions and fatalities have been reported. 1st sign of acute toxicity, determine serum drug level. Caution, patients with: Hypotension, severe myocardial insufficiency, diabetes, porphyria, impaired liver function. Discontinue if skin rash appears (only resume if mild rash and it has cleared). Contains propylene glycol, Na+, ethanol. Pregnancy, lactation. C Certain anticonvulsants, antidepressants, anticoagulants, Ca++ channel blockers, antifungals. Amiodarone, chloramphenicol, chlordiazepoxide, diazepam, disulfiram, oestrogens, H2-antagonists, halothane, isoniazid, methylphenidate, ELANTAN UCB omeprazole, phenylbutazone, salicylates, folic acid, rifampicin, sucralfate, theophylline, vigabatrin, St 2M John’s wort, antineoplastics, certain antacids, Nitrate. Isosorbide mononitrate 10mg, 20mg, ciprofloxacin, alcohol, phenothiazines. See SPC. 40mg. White scored tabs. marked E20 or E40. A Toxicity (signs are associated with A A 10mg-56, 4.43; 10mg-84, 6.64; 20mg-56, cardiovascular and CNS depression), inj. site A5.64; 20mg-84, A8.00; 40mg-56, A9.20; 40mgreactions, rash, haemopoietic complications, GI 84, A13.77. disorders, hypersensitivity, polyarthropathy, S As adjunctive therapy in chronic congestive heart failure not responding to cardiac interstitial nephritis, pneumonitis. glycosides or diuretics. EUCARDIC Roche P 40-80mg daily in two or three divided 3MO doses after meals; max. 120mg daily. Q Not recommended. a/b-blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, A Headache, flushes, dizziness. 25mg. Resp. pink, yellow, light brown or pale beige round scored tab. marked BM on one side ENAP Rowex and K1, F1, H3 or D5 on other side. 3.125mg-28, A3.67; 6.25mg-28, 4.36; 12.5mg-28, A4.78; 25mg2MO 28, A5.72. ACE inhibitor. Enalapril maleate 5mg, 10mg, S Adjunctive therapy for the treatment of 20mg. White, red and orange tabs marked EN 5, EN 10 and EN 20 resp. All scored, oblong. 5mg-30, symptomatic CHF to reduce morbidity and increase A6.34; 10mg-30, A8.89; 20mg-30, A10.57. patient well-being. P Dosage should be titrated to individual S Heart failure (HF). HF prevention in requirements and monitored during up-titration. asymptomatic left ventricular dysfunction. Initially, 3.125mg twice daily with food for 2 P Initially 2.5mg once daily increasing weeks. If tolerated, titrate at min. 2 week intervals gradually over 2-4 weeks to maintenance 20mg to 6.25mg twice daily, then to 12.5mg twice daily, daily given in single or two divided doses. Max, then 25mg twice daily. Max. 25mg twice daily in 40mg daily in two divided doses. Q Not recommended. patients under 85kg, or 50mg twice daily in D Angioedema. Pregnancy, lactation. patients over 85kg. B Kidney transplantation (avoid), renal Q Under 18 years, not recomennded. artery stenosis, aortic or mitral valve stenosis, D See 2.4, b-blockers Drug Presc. Notes. diabetes, collagen vascular disease, surgery, renal NYHA class IV decompensated HF requiring IV impairment, jaundice (discontinue if occurs). inotropic support, liver dysfunction. Contains Reduce dose of diuretic, if possible prior to lactose. therapy, as vol. depletion may cause symptomatic HYPOVASE Pfizer hypotension. Contains lactose. C Other anti-hypertensive agents, 2MO K+suppl., K+sparing and other diuretics, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. TCAs, antipsychotics, anaesthetics, White tab. marked Pfizer and white tab. scored sympathomimetics, antidiabetics, antacids, NSAIDs, and marked M6, resp. B.D. Starter pack (8 x alcohol, immunosuppressants, allopurinol, 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; procainamide. 1mg-56, A4.07. A Blurred vision, dizziness, hypotension, S Congestive cardiac failure. headache, depression, cough, dyspnoea, asthenia, P Initially 500mcg two, three or four times nausea, GI disorders, rash, angioneurotic oedema, daily, increasing to 4mg in divided doses; serum creatinine increase, hyperkalaemia. maintenance 4-20mg daily in divided doses. Q Not recommended. EPANUTIN Parke-Davis D Sensitivity other quinazolines. CCF due 2NO to aortic and mitral valve stenosis, pulmonary Class I antiarrhythmic. Phenytoin Na+ 50mg/ml. embolism and restrictive pericardial disease. A Soln for inj. or inf. Amp. 5ml x 10, 48.30. B HF due to recent MI; insufficient data. Pregnancy, lactation. Initial low dose and gradual S Cardiac arrhythmias where 1st line titration is recommended. therapy is not effective, particularly digitalisC Other antihypertensives. Caution: PDE-5 induced. inhibitors. P Initially 3.5-5mg/kg IV repeated once if
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
25
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
change in dosage. Monitor periodically thereafter especially in patients at risk for hyperkalaemia (eg. elderly, renal insufficiency, diabetes). Impaired INDERAL AstraZeneca renal and hepatic function. Pregnancy. Contains lactose. 3MO C K+-sparing diuretics, K+-suppl., strong Non-cardioselective b-blocker. Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg- inhibitors of CYP3A4 eg. itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, 100, A1.20. telithromycin and nefazodone (all S Prevention of myocardial reinfarction. contraindicated). Strong CYP3A4 inducers, lithium, Cardiac dysrhythmias. cyclosporin and tacrolimus (avoid). Caution: Other P Reinfarction: 40mg four times daily for CYP3A4 inhibitors, NSAIDs, trimethoprim, ACE two or three days starting 5 to 21 days after infarction, then 80mg twice daily. Arrhythmias: 10- inhibitors or aII antagonists, a-1 blockers, TCAs, neuroleptics, amifostine, baclofene, 40mg three or four times daily. Q Arrhythmias, 0.25-0.5mg/kg body weight glucocorticoids, tetracosactide, digoxin, warfarin. A Hyperkalaemia, dizziness, hypotension, three or four times daily. diarrhoea, nausea, abnormal renal function. D See 2.4, b-blockers Drug Presc. Notes. Contains lactose. A Dizziness, blurred vision, dry mouth, nausea, impotence.
CIRCULATORY SYSTEM ALSO LANOXIN-PG ELIXIR Digoxin 50mcg/ml. 60ml, A5.36.
2NO
ALSO LANOXIN INJECTION Digoxin 0.25mg/ml. 2ml amp. 5, A3.72. S Digitalis therapy, particularly congestive heart failure. P Maintenance, 0.25-0.5mg daily. Elderly, 0.125-0.25mg daily; maintenance, 0.125-0.25mg daily. Q Maintenance, 10-20mcg/kg daily in single or divided doses. D Ventricular tachycardia. Hypertrophic obstructive cardiomyopathy. Elective electroconversion. Hypercalcaemia. B Acute myocardial infarction. AV block. Cation imbalance, severe pulmonary disease, elderly patients, renal insufficiency, thyroid ISOKET 0.1% UCB dysfunction. C Ca++ inj. or suppl., other cardiac 2 N INNOVACE MSD glycosides, K+depleting agents, quinidine, lithium, Nitrate. Isosorbide dinitrate 1mg/ml. Amps.-10 x 2MO antacids, antibiotics. 10ml, A59.11; Bottles-50ml, A29.33; 100ml, ACE inhibitor. Enalapril maleate 2.5mg, 5mg, A GI, visual and conduction disturbances. A40.50. 10mg, 20mg. 2.5mg: White, round, biconvex tabs. 2N marked MSD 14; 5/10/20mg: White, rust-red and LESTACE Actavis ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ peach rounded triangle-shaped tabs. scored on 2MO one side and marked MSD 712, MSD 713 and MSD ml. 50ml, A15.69. ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. 714 resp. on the other. 2.5mg-28, A6.49; 5mg-28, S Unresponsive left ventricular failure secondary to acute myocardial infarction, Round tabs, can be divided in equal halves. 2.5mg: A3.56; 10mg-28, A4.99; 20mg-28, A 5.93. White, biconvex. 5mg: White, flat, scored both S Treatment of symptomatic heart failure. unresponsive LVF of various aetiology. P 2-10mg/hour adjusting according to sides. 10mg: Light pink, biconvex, scored one side. Prevention of symptomatic heart failure in response. Max. 20mg/hour. 20mg: Pink, biconvex, scored one side. 2.5mg-28, patients with asymptomatic left ventricular A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, Q Not recommended. dysfunction. A10.16. D Uncompensated cardiac shock. Severe P Initially 2.5mg in conjunction with hypotension. Marked anaemia. Cerebral S Symptomatic HF. Short-term (6 weeks) diuretics and, where appropriate, digitalis or bhaemorrhage. treatment of haemodynamically stable patients blockers; titrate over 2-4 weeks to usual within 24 hours of acute MI. maintenance dose of 20mg in single or twice daily A Headache, flushes, dizziness. P HF: Initially 2.5mg once a day under dose. Max. 40mg daily in two divided doses. ISOPTIN Abbott medical supervision. Increase to highest tolerated Q Not recommended. dose, up to max 35mg once a day by increments 2MO D Angioedema. Pregnancy, lactation. of 10mg max and at intervals of 2 weeks B Reduce dose of diuretic, if possible, Class I Ca++ antagonist. Verapamil 40mg, 80mg, minimum. Acute MI: Do not start if systolic arterial before initiating therapy. Volume depletion may 120mg. White film-ctd tabs. 40mg-100, A2.12; pressure Q100mmHg. Initially (first 3 days postcause symptomatic hypotension. LV valvular and 80mg-100, A4.24; 120mg-100, A6.36. MI), 5mg orally, followed by 5mg after 24 hours, outflow tract obstruction, renal impairment, renal S Supraventricular tachycardia, atrial 10mg after 48 hours and 10mg/day thereafter. artery stenosis, surgery. Angioneurotic oedema fibrillation and atrial flutter. (discontinue promptly). Contains lactose. P 40-80mg three times daily or 120-240mg Patients with low systolic arterial pressure (R120mmHg) at start of treatment or within first C Other anti-hypertensive agents, lithium, twice daily. Higher dosage, see SPC. 3 days of infarct: 2.5mg orally. Maintenance, 10mg K+suppl., diuretics, antidiabetics, TCAs, NSAIDs, Q Not recommended. once daily. Reassess after 6 weeks. If hypotension sympathomimetics, alcohol, gold. 2NO occurs: 5mg with temporary decrease to 2.5mg if A Cough, nausea, blurred vision, dizziness, ALSO ISOPTIN INJECTION Verapamil 5mg/2ml necessary; withdraw if hypotension prolongs. hypotension, syncope, angina pectoris, amp. 5, A6.44. tachycardia, headache, depression, dyspnoea, GI S Acute angina pectoris. Tachyarrhythmias Renal impairment, ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ disorders, taste alteration, rash, hypersensitivity/ and hypertensive crisis. angioneurotic oedema, asthenia, fatigue. P 1 amp. slow i.v. if necessary a second or min, initially 5-10mg/day. Q Not recommended. third at 5-10 mins. interval. INSPRA Pfizer Q Neonates, 0.75-1mg. Infants, 0.75mg. 1- D History of angioedema associated with previous ACE inhibitor therapy. Hereditary or 5 years, 2-3mg; 6-14 years, 2.5-5mg. 5MO idiopathic angioedema. Pregnancy, lactation. Aldosterone antagonist. Eplerenone 25mg, 50mg. D Cardiogenic shock. 2nd or 3rd degree B Caution: Acute MI (do not use: Renal AV block. Severe bradycardia. Uncompensated Yellow film-ctd tab. marked Pfizer on one side, dysfunction, systolic BP R100mmHg, cardiogenic cardiac failure. Sick sinus syndrome. and NSR over strengh on reverse. 25mg-28, shock), mitral stenosis and left ventricle outflow B 1st degree AV block. Poor cardiac A56.00; 50mg-28, A56.00. obstruction (aortal stenosis, hypertrophic reserve should be controlled with digitalis and S In addition to standard therapy incl. bmyocardiopathy), bilateral renal artery stenosis or diuretics. Hepatic impairment. Acute phase of blockers, in stable patients with left ventricular stenosis of the artery in a single kidney (strict myocardial infarction. Bradycardia. dysfunction (LVEFR40%) and heart failure after supervision with low doses; careful dose C b-blockers, quinidine or digoxin. recent MI. adjustment), pre-existing renal impairment A Constipation, headache, flushes. P Maintenance dose, 50mg once daily. (monitor blood K+, creatinine), major surgery, Initially, 25mg once daily, titrated to 50mg once LANOXIN GSK anaesthesia, renal insufficiency, diabetes. May daily preferably within 4 weeks, taking into occur: Systemic hypotension, angioedema 2MO account K+ level (see SPC). Start within 3-14 days (withdraw immediately if occurs), anaphylactoid Cardiac glycoside. Digoxin 0.25mg. White scored after MI. reactions in haemodialysis patients or during A8.37. tab. marked WELLCOME X3A. 500, Q Not recommended. desensitisation treatment, acute renal insufficiency + 2 M O D Serum K q5mmol/L at initiation. in patients with HF (usually reversible), hepatic ALSO LANOXIN-PG Digoxin 62.5mcg. Blue tab. Moderate to severe renal insufficiency, severe insufficiency, neutropenia/agranulocytosis, cough. marked WELLCOME U3A. 500, A7.85. hepatic insufficiency. Lactation. C Not recommended: Lithium. Caution: + Diuretics, K+-sparing diuretics, K+ containing B Monitor serum K at initiation and with 2 M O
26
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
2.1
sympathomimetics, lithium, antacids, NSAIDs, alcohol, anaesthetics, narcotics, hypnotics, oral hypoglycaemic agents, diuretics, NaCl. A Hypotension, dry cough, sore throat, bronchitis, dizziness, feeling weak, impaired vision, nausea, stomach pain, indigestion, rash, headache, tiredness, palpitations, renal failure.
losartan. Patients should have left ventricular ejection fraction R40% and be stabilised under treatment of chronic HF. P Initially 12.5mg once daily. Increase at weekly intervals to maintenance of 50mg once daily. Usually combine with a diuretic, digitalis and/or a b-blocker. Patients with intravascular volume depletion: 25mg once daily initially. LOAVEL sanofi-aventis Hepatic impairment: Consider lower dose. LEVOPHED Hospira 2 M O R Over 75 years, consider initiating therapy with 25mg. 0JN ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, Q Not recommended. 10mg. White, yellow, red and white oblong tabs. Sympathomimetic amine. Noradrenaline (as acid D Pregnancy, lactation. Severe hepatic with score line on both sides. 1.25mg-28, A2.57; tartrate) 1mg/ml. Amp. 6 x 2ml, A6.93. 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. impairment. B History of angioedema (closely monitor). LISOPRESS Niche S Congestive heart failure; as adjunctive Volume depletion may cause symptomatic to diuretics with or without cardiac glycosides. 2MO hypotension. Monitor K+ and cc. Hepatic Post MI in patients with heart failure. Prevention ACE inhibitor. Lisinopril 2.5mg white scored tab. impairment, renal impairment, renal artery of MI, stroke or cardiovascular death in patients marked 2.5; 5mg white scored tab. marked 5; stenosis, primary aldosteronism (not with an increased cardiovascular risk who are 10mg white square tab. scored and marked 10; recommended), ischaemic cardiovascular and already taking standard therapy and in type 2 20mg white pentagonal tab. scored and marked diabetic patients with an increased cardiovascular cerebrovascular disease, aortic or mitral valve 20. 2.5mg-28, A4.63; 5mg-28, A7.11; 10mg-28, stenosis, obstructive hypertrophic cardiomyopathy. risk. A8.77; 20mg-28, A9.59. No sufficient therapeutic experience: HF with P CHF: Initially 1.25mg once daily, then S Adjunct to diuretics and where double dose at intervals of 1-2 weeks according to concomitant severe renal impairment, severe HF, appropriate digitalis in congestive heart failure. response; max. 10mg daily. Reduce dosage of any HF and symptomatic life threatening cardiac Acute MI in haemodynamically stable patients. diuretics first. Initiate therapy under close medical arrhythmias. Contains lactose. P CHF, initially 2.5mg once daily in the C Caution: Other antihypertensives, supervision. Post MI: Initiate in hospital between morning increasing gradually over 2-4 weeks to fluconazole, rifampicin, NSAIDs, lithium (monitor maintenance 5-20mg once daily. If possible reduce days 3-10 post-MI. Initially 2.5mg twice daily. After levels). Not recommended: Heparin, K+ sparing 2 days, increase to 5mg twice daily. If starting dose of any diuretic first. Initial therapy under diuretics, K+ supplements or salts. dose not tolerated, reduce to 1.25mg twice daily close medical supervision (in hospital for severe for 2 days. Then increase to 2.5mg twice daily. If unstable HF or high risk patients). Acute MI, LOTANOS Rowex necessary, increase to 5mg twice daily 2 days later. initially 5mg followed by 5mg after 24 hrs, 10mg 2MO Withdraw if dose cannot be increased to 2.5mg after 48 hrs and then 10mg once daily. Angiotensin II antagonist. Losartan K+ 50mg, twice daily. Usual maintenance dose 2.5- 5mg Q Not recommended. 100mg. White oblong tab. Resp. with 1 or 3 twice daily. Prevention of MI, stroke or D Pregnancy, lactation. Renal artery notches on each side and embossed with 3 or 5 on cardiovascular death: Initially 2.5mg once daily, stenosis, severe renal impairment, one side. 50mg-28, A11.73; 100mg-28, A19.71. the dose is gradually increased. Double the dose haemodynamically relevant aortic or mitral valve S Heart failure (HF), when treatment with after 1 week and after another 3 weeks increase stenosis, haemodynamically unstable patients after ACE inhibitors is no longer appropriate; patients to 10mg. Usual maintenance dose is 10mg. acute MI. with HF stable with an ACE inhibitor should not R Consider initial dose of 1.25mg daily. B Haemodialysis. Hypotension, unstable be switched to Lotanos. Titrate according to need for BP control. cardiac failure, renal impairment, renovascular P Initially 12.5mg once daily. Q Not recommended. hypertension, primary hyperaldosteronism, proteinuria, angioneurotic oedema, aortic stenosis, D History of angiooedema. Aortic stenosis Recommended titration: 7 days at 12.5mg daily, followed by 25mg daily for a further 7 days and or outflow obstruction. Renal artery stenosis, surgery/anaesthesia. C K+ sparing diuretics, K+ suppl., diuretics, hypotensive or haemodynamically unstable states. then increase to 50mg daily. D Pregnancy, lactation. Pregnancy, lactation. Na+, Cl, antihypertensive agents, analgesics, antiB Volume depletion may cause inflammatory agents, lithium, alcohol, B CHF, hepatic impairment, blood symptomatic hypotension. Caution: Hepatic anaesthetics, hypnotics, narcotics, dyscrasias. Renal impairment: Reduce dose and impairment (dose adjustment), renal impairment sympathomimetics, antacids. assess renal function prior to and during A Hypotension, dizziness, weakness, treatment. Caution: Patients with hyper stimulated (hyperkalaemia risk). May occur: Angioedema, changes in renal function. No data on use in impaired vision, syncope, tachycardia, palpitations, angiotension system. Electrolyte monitoring haemodynamically significant obstructive valvular arrhythmias, chest pain, angina. recommended. Haemodialysis (avoid in patients disease. Contains lactose. dialysed with high flux membranes). Malignant C Caution: Rifampicin, fluconazole, K+ LISPRIL Rowex hypertension: Initiate in hospital under close sparing diuretics, K+ supplements or salt supervision. Symotomatic hypotension, 2MO substitutes containing K+, indomethacin. agranulocytosis/bone marrow depression, ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, hyperkalaemia have been reported rarely. Caution: A Dizziness, hypotension. 20mg. Slightly red scored tabs. 5mg-30, A8.13; Surgery and during anaesthesia. 10mg-30, A10.03; 20mg-30, A11.51. METOCOR Rowex C Antihypertensive agents, K+sparing S Congestive heart failure as adjunctive diuretics, K+suppl., lithium, sympathomimetics, 3MO therapy to non-potassium sparing diuretics. Acute antidiabetic agents, NSAIDs. Cardioselective b-blocker. Metoprolol tartrate MI. A Nausea, dizziness, headache, dry tickling 50mg, 100mg. White tabs. scored one side. 50mgP HF: Initially 2.5mg in the morning, cough. 100, A3.50; 100mg-100, A6.50. maintenance 5-20mg once daily. MI: Initially 5mg S Prevention of cardiac mortality then 5mg 24 hours later, maintenance 10mg. LOSARTAN TEVA Teva following myocardial infarction. Cardiac R Initially 2.5mg increasing to 5-10mg arrthythmias, especially supraventricular 2MO once daily. tachyarrhythmias. Angiotensin II antagonist. Losartan (K+) 50mg, Q Not recommended. P Reinfarction, initial therapy: See SPC. 100mg. White, oval, slightly arched film-ctd tabs, D History of angioneurotic oedema Maintenance: 200mg daily. Arrythmias: 50mg two debossed with strength on one side, scoreline on related to previous ACE-inhibitor treatment. or three times daily; max. 300mg daily. A A the other. 50mg-28, 12.45; 100mg-28, 20.94. Pregnancy, lactation. st Q Not recommended. S Chronic HF, when treatment with ACE B Renal impairment, hypotension (1 D See 2.4, b-blockers Drug Presc. Notes. dose), aortic stenosis, acute MI, multiple or high inhibitors not suitable due to incompatibility or dose diuretic therapy. contraindication. Patients with HF stabilised with METOP Gerard + C K suppl., antihypertensive agents, an ACE inhibitor should not be switched to supplements and salts, NSAIDs (incl. acetylsalicylic acid r 3g/day), other antihypertensives, injectable gold, certain anaesthetic drugs, TCAs, antipsychotic agents, sympathicomimetics, antidiabetics. A Dizziness, headache, cough, diarrhoea, vomiting, renal dysfunction, orthostatic effects (incl. hypotension).
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
27
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; 100mg-100, A6.51. S Prevention of cardiac mortality following myocardial infarction. Supraventricular arrhythmias. P Reinfarction, initial therapy: See SPC.: Maintenance: 200mg daily. Arrhythmias: 50mg two or three times daily; max. 300mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
NEBILET
A. Menarini
3MO Vasodilating cardioselective b-blocker. Nebivolol (as HCl) 5mg. White cross scored tab. 28, A12.94. S Stable mild and moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients r70 years. P Patients receiving cardiovascular drug therapy should be stabilised during the 2 weeks prior to treatment. Initially, 1.25mg once daily. Titrated up through 2.5mg, 5mg and 10mg at 1-2 weekly intervals. Initiate and increase dose under close medical supervision. If necessary discontinue gradually (dose divided into halves weekly). Max. 10mg once daily. Q Children and adolescents, not recommended. D See 2.4, b-blockers Drug Presc. Notes. Liver insufficiency or liver function impairment.
NITROCINE
UCB
2N Nitrate. Glyceryl trinitrate 1mg/ml. Soln. in amps. and bottles. Amps.-10 x 10ml, A128.94; Bottles-1 x 50ml, A30.22. S Rapid control of hypertension and myocardial ischaemia during cardiac surgery. Reduction of BP and controls for hypotension during surgical procedures. Treatment of unresponsive CHF secondary to acute MI. Indicated for unstable angina. P Surgery: Starting dose 25mcg/min increased by increments of 25mcg/min at 5 min intervals until BP stabilised. 10 -200mcg/min sufficient; max. 400mcg/min. Perioperative myocardial ischaemia: 15 – 20mcg/min with increments of 10 -15mcg/min until stabilised. Unresponsive CHF: 20 -25mcg/min increased in steps of 20 -25mcg/min every 15 – 30mins until stabilised. Lowest dose: 10mcg/min. Unstable angina: Initial dose 10mcg/min with increments of 10mcg/min every 30 mins. D Anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia, severe hypotension. Pregnancy, lactation. B Monitor pulse and BP. Hypothyroidism, severe liver/renal disease, hypothermia, malnutrition. C b blockers, Ca++ antagonists, alcohol. PDE-5 inhibitors e.g. Sildenafil. Do not admin. within 48 hours after taking PDE-5 inhibitors. Neuroleptics, TCAs. A Headaches, nausea, hypotension, tachycardia, retching, sweating, apprehension, restlessness, muscle twitching, retrosternal discomfort, palpitations, dizziness, abdominal pain.
NORTENOLOL
Tillomed
3MO Cardioselective b-blocker. Atenolol 25mg,
28
CIRCULATORY SYSTEM
50mg,100mg. White, white, orange unscored filmctd tabs. marked A25, A50, A100 resp. 25mg-30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. S Cardiac dysrhythmias. Early intervention in acute MI. P 50-100mg daily. MI: 5-10mg atenolol IV followed by 50mg tab 15min later and another 50mg tab 12 hours after IV inj. Then 12 hours later, 100mg once daily. Renal impairment: See SPC. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
Based on cc (see SPC). R CAD: Initially 2mg once daily in 1st week, then 4mg once daily the next week, then up to 8mg once daily depending on renal function. Q Not recommended. D Angioedema, history of ACEI related angioedema. Pregnancy, lactation. B Symptomatic hypotension may occur. Correct salt depletion / hypovolaemia, if possible, prior to therapy. Monitor renal function and serum K+ before and during treatment. Caution: Severe HF impaired renal function, tendency for PENDREX Rowex electrolyte disturbance, mitral valve stenosis, obstruction in the outflow of the left ventricle, 2MO collagen vascular disease, anaesthesia (discontinue ACE inhibitor. Perindopril tert-butylamine 2mg one day prior to surgery), patients at risk of (1.67mg perindopril), 4mg (3.34mg perindopril). White, round, biconvex tablet debossed with 2 or hyperkalemia. May occur: Unstable angina pectoris (re-evaluate), jaundice, angioedema (promptly 4 on one side. 2mg-30, A8.53; 4mg-30, A12.07. discontinue), anaphylactoid reactions (interrupt S Symptomatic heart failure. during LDL aphaeresis or desensitisation). Contains P Use in combination with a non K+sparing diuretic and/or digoxin and/or a b-blocker. lactose. C Not recommended: Lithium, K+-sparing Initially 2mg, may be increased to 4mg by diuretics, K+ suppl, diuretics. Caution: increments of 2mg at intervals of no less than 2 Immunosuppressant, allopurinol or procainamide, weeks. Severe HF or high risk patients: Initiate oral antidiabetics, NSAIDs, vasodilators, certain under careful supervision. Renal impairment: See anaesthetics, TCAs, antipsychotics, SPC. sympathomimetics. Q Not recommended. A Headache, dizziness, vertigo, D History of angioedema associated with paresthaesia, vision disturbance, tinnitus, previous ACE inhibitor therapy. Hereditary or hypotension, cough, dyspnoea, GI disorders, rash, idiopathic angioedema. Pregnancy, lactation. B If unstable angina pectoris occurs in 1st pruritus, muscle cramps, asthenia. month, reappraise benefit/risk before continuing PERFAN Myogen treatment. Volume depletion, symptomatic HF 2N may cause symptomatic hypotension. Caution: Selective inhibitor of PDE-III. Enoximone 5mg/ml. Mitral valve stenosis, aortic stenosis, hypertrophic Amp. 10 x 20ml, A179.90. cardiomyopathy, collagen vascular disease, S Congestive heart failure. immunosuppressant therapy, treatment with P Dilute before admin. Loading: Initially allopurinol or procainamide, diabetes. Renal 0.5mg/kg at a rate not greater than 12.5mg/min. impairment: Adjust dosage according to cc and May be repeated after 30 mins. Maintenance: Inf. response to treatment. Anaphylactoid reactions 2.5-5mcg/kg/min. See SPC. may occur during dialysis with high flux Q Not recommended. membrane or low-density lipoproteins apheresis with dextran sulphate. Discontinue if angioedema D Lactation. occurs. May occur: Hepatic syndrome, neutropenia/ B Monitor platelet counts, BP, heart rate, ECG, hepatic and renal function. Congestive agranulocytosis, thrombocytopenia, anaemia, cardiac failure associated with blood platelet persistent non-productive cough, elevation in counts below 100,000/ml. Pregnancy. serum K+. Discontinue 1 day prior to surgery. + + C Avoid: Diuretics, K sparing diuretics, K - A Hypotension, chest pain, abnormal heart beat, breathlessness, headache, insomnia, + containing salt substitutes, K supplements, nausea, vomiting, diarrhoea, chills, fever. lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, PHYLLOCONTIN CONTINUS antipsychotics, anaesthetics, sympathomimetics, Mundipharma antacids. 2MO A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, Xanthine. Aminophylline 225mg. Pale yellow filmhypotension and related effects, cough, dyspnoea, ctd sust.-release tab. marked SA one side, Napp GI disturbances, rash, pruritus, asthenia. logo on reverse. 56, A3.91. S Cardiac asthma and left ventricular or PERCARNIL Actavis congestive cardiac failure. P Initially 1 tab. 12-hourly for one week, 2MO then maintenance 2 twice daily. ACE inhibitor. Perindopril (tert-butylamine salt) 4mg, 8mg. White tabs, PP marked on one side and Q Not recommended. strength on reverse. 4mg oblong with a break-line D Hypersensitivity to xanthine group of drugs. Pregnancy (only if essential), lactation. on both sides; 8mg circular. 4mg-30, A9.92; 8mgB Cardiac or liver disease, viral infection, 30, A16.29. S Symptomatic heart failure. Reduction of elderly; reduce dose. History of seizure (not risk of cardiac events in patients with a history of advised), insomnia. C Cimetidine, erythromycin, b-adrenergic MI or revascularisation. P HF: Initially 2mg in the morning; may be agonists, glucagon, ephedrine. increased by increments of 2mg at intervals of no A Nausea, gastric irritation, headache, CNS stimulation. less than 2 weeks to 4mg once daily if tolerated. CAD: Initially 4mg once daily; after two weeks PRINDACE Clonmel increase to 8mg once daily. Renal impairment:
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
2.1
White marked R4. 2.5mg-28, A5.80; 5mg-28, A8.10; 10mg-28, A11.04. S High-risk patients with CVD or type 2 diabetes with at least one additional risk factor. Mild to moderate heart failure after acute stage of MI. P CVD/diabetes: Initially, 1.25-2.5mg once daily; may be increased by doubling with min. 3 week interval. Maintenance, 5mg daily; max, 10mg daily. HF after MI: Start at least 3 days after MI. Initially, 1.25-2.5mg twice a day with strict monitoring of BP and renal function; increase after min. 2 days to 2.5-5mg twice a day. Target dose, 5mg twice a day. Hypertension with HF: Initially 1.25mg once daily. On diuretics: Discontinue diuretic 2-3 days before therapy (or earlier if long-acting). If diuretic cannot be discontinued, initial dose 1.25mg. Renal impairment: cc Q50ml/min, initially 1.25mg once daily; max. 5mg once daily; cc Q20ml/min, initially 1.25mg every second day; max. 2.5mg once daily. Q Not recommended. RAMILO Rowex D Hypersensitivity to any ACE inhibitors. Angioneurotic oedema. Renal artery stenosis, 2MO kidney transplantation. Renal dysfunction or ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, hypotension in patients with acute MI. Primary 10mg. White, oblong, biplane with facet tabs. hyperaldosteronism. Pregnancy, lactation. marked R 1.25, R 2.5, R 5, and R 10 on one side. Both sides with breaking notch. 1.25mg-30, A4.39; B Mitral valve stenosis or outflow obstruction (caution). Jaundice (discontinue). 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, Haemodialysis using high-flux membranes (risk of A11.78. anaphylactoid reactions). Fluid/salt abnormalities, PRONESTYL BMS S Symptomatic heart failure, cardiac severe hypertension, elderly. If potential for 2MO failure following myocardial infarction (MI). symptomatic hypotension; monitor closely. Class I antiarrhythmic. Procainamide (HCl) 250mg. P CHF: Initially 1.25mg once daily Surgery/anaesthesia. Bone marrow depression, White scored tab. marked SQUIBB 754. 100, swallowed whole with plenty of fluid. May be hyperkalaemia, angioneurotic oedema have been A6.42. increased at intervals of 1-2 weeks to 1.25mg reported. Contains lactose. Driving/using machines. S Cardiac arrhythmias. twice daily, then 2.5mg twice daily. Target, 10mg C Caution: K+ sparing diuretics, K+ P 50mg per kg daily in divided doses daily. Uncomplicated cases, initially 1.25mg once supplements, diuretics, nitrates, other vasodilators, three to six hourly. daily, increased to 1.25mg twice daily on day 2-7, heparin, alcohol, allopurinol, procainamide, Q Not recommended. then to 2.5mg twice daily on week 2, and 5mg cytostatics or immunosuppressants, trimethoprim, 2NO twice daily on week 3. Maintenance, single or two antidiabetics, sympathomimetics, NSAIDs. Avoid divided doses. Post- MI: Initiate on day 3-10 after ALSO PRONESTYL INJECTION Procainamide (HCl) lithium. A MI in stable patient with 1.25-2.5mg twice daily; 100mg/ml. 10ml multidose vial. 1, 2.21. A Dizziness and headache, orthostatic P See SPC. increase after no less than 2 days to 2.5-5mg twice effects, diarrhoea, vomiting, cough, renal Q Not recommended. daily. Target, 5mg twice daily; later may be taken impairment. D AV block. SLE. as single daily dose. Max. 10mg daily. Concomitant B Elderly. Renal, hepatic or cardiac failure. diuretic treatment/ nephropathy: Initially 1.25mg RAMYTE Actavis Myasthenia gravis. Perform regular serological once daily. Renal impairment: See SPC. Impaired 2MO tests. Pregnancy. Contains: Na+ metabisulphite, hepatic function: Max. 2.5mg daily. ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 benzyl alcohol, Na+ (less than 1mmol/dose). Q Not recommended. hard cap. containing white powder, with light A GI disturbance, SLE, leucopenia, D Angioedema, history of angioedema grey body and resp. light green, green or dark agranulocytosis. with previous ACE inhibitor therapy. Pregnancy, green cap, marked R on cap and strength on lactation. body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, RAMIC Pinewood B If possible, discontinue diuretic A10.92. treatment 2-3 days before therapy initiation. 2MO S Reduces mortality in patients surviving Volume depletion may cause symptomatic ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Hard acute MI with clinical evidence of HF. caps. with light grey body and light green, green, hypotension. Caution: LV valvular and outflow P Initiate in hospital between day 3 and and dark green cap marked R on cap and strength tract obstruction, renal impairment, renal artery day 10 following AMI. Initially, 2.5mg twice daily on body. 2.5mg-28, A6.07; 5mg-28, A8.46; 10mg- stenosis, haemodialysis patients, surgery. for 2 days. Then increase to 5mg twice a day. Discontinue if jaundice occurs. Driving/ operating 28, A11.54. Withdraw treatment if dose cannot be increased machines. S Congestive heart failure (CHF), as to 2.5mg twice daily. Maintenance: 2.5mg-5mg C Lithium (not recommended). Caution: adjunctive therapy to diuretics with or without twice daily. Renal/hepatic impairment, see SPC. + suppl. or Other anti-hypertensive agents, K cardiac glycosides. Reduce mortality in patients R Caution. K+sparing diuretics, diuretics, TCAs, anaesthetics, surviving acute MI. D History of angioneurotic oedema antipsychotics, antidiabetics, NSAIDs, P CHF: Patients stabilised on diuretic relating to previous ACE inhibitor treatment. sympathomimetics. therapy, initially 1.25mg once daily; may be Pregnancy, lactation. Use in children. A Dizziness, headache, cough, orthostatic doubled at intervals of 1-2 weeks. Max. 10mg B Aortic stenosis or outlaw obstruction effects (incl. hypotension), diarrhoea, vomiting, (not recommended). Renal impairment risk daily. Patients previously on high dose diuretic (dosage reduction and/or discontinue); assess renal should have diuretic dose before starting. Post MI: renal dysfunction. function prior to and during treatment. Caution: Start treatment in hospital between day 3 and 10 RAMITACE Clonmel Impaired liver function, volume- and salt-depletion post acute MI. Initially, 2.5mg twice a day, 2 M O (symptomatic hypotension risk), anaesthesia, increased to 5mg twice a day after 2 days. If surgery. May occur rarely: Agranulocytosis and 2.5mg not tolerated, start with 1.25mg twice a ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Cap.bone marrow depression, reduction in red cell day for 2 days before increasing to 2.5mg and shaped, flat tabs. scored on one side. 2.5mg: count, haemoglobin content and platelet count, 5mg twice a day; withdraw if cannot be increased Yellow marked R2. 5mg: Pink marked R3. 10mg:
2MO
ACE inhibitor. Perindopril tert-butylamine 4mg. 30, A7.24. S Symptomatic heart failure. P Initially 2mg daily; may be increased after 2 weeks to 4mg once daily if tolerated. Renal impairment, see SPC. Q Under 18 years, not recommended. D Angioedema. Pregnancy, lactation. B Increased risk of symptomatic hypotension eg. salt depletion, hypovolaemia, diuretics; correct, if possible, prior to therapy. Monitor BP, renal function, serum K+ closely, before and during treatment. Hyperkalemia, increases in blood urea and plasma creatinine. Caution: Mitral valve stenosis, obstruction in the outflow of left ventricle, diabetes. LDL apheresis. Jaundice, angioedema (facial/ intestinal) reported rarely; discontinue promptly. Discontinue one day prior to surgery. Contains lactose. C Lithium, K+ supplements (not recommended), diuretics. Caution: NSAIDs, antihypertensives, vasodilators, antidiabetics, anaesthetics, TCAs, antipsychotics, sympathomimetics, injectable gold. A Hypotension, headache, dizziness, vertigo, paraesthesia, vision disturbance, tinnitus, cough, dyspnoea, GI disorders, dysgeusia, dyspepsia, rash, pruritus, muscle cramps, asthenia.
to 2.5mg twice a day. Maintenance: 2.5-5mg twice a day. Q Not recommended (contra). D History of angioneurotic oedema relating to previous ACE inhibitor treatment. Pregnancy, lactation. B Aortic stenosis, outflow obstruction (not recommended). Hypotension, agranulocytosis, bone marrow depression, hyperkalaemia, angioneurotic oedema may occur. Assess renal function prior to and during treatment. Impaired liver function (reduce dose), collagen vascular disease; monitor. Correct volume/salt depletion before initiating therapy. Surgery/ anaesthesia. Haemodialysis using high-flux membranes (avoid). Driving/ operating machines. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness, headache, GI disturbances, dry tickling cough, skin/mucosal reactions, sinusitis, bronchitis, conjunctivitis, hair loss.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
29
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
to cardiac arrhythmia. Cardiogenic shock. Cardiomyopathy or severe uncompensated HF. Children. Renal/hepatic impairment. Pregnancy, lactation. B 1st degree AV block. Cardiac failure should be controlled with glycosides.Caution: Hypokalaemia (check K+ levels regularly), renal/ hepatic insufficiency, narrow-angle glaucoma, Prostatic hypertrophy (risk of urinary retention). May occur: Hypotension (discontinue immediately), arrhythmias, hypoglycaemia (discontinue), aggravation of myasthenia gravis. C Contra: Other antiarrhythmics or other drugs liable to provoke ventricular arrhythmias (esp. torsades de pointes). Not recommended: PDE5 inhibitors, CYP3A inhibitors and inducers. Caution: Drugs associated with Torsades de Pointe risk (tricyclic and tetracyclic antidepressants, erythromycin (IV), astemizole, cisapride, pentamidine, pimoxide, sparfloxacin, terfenadine)., hypokalaemia inducing drugs (diuretics, amphotericin B, tetracosactide, gluco and REVATIO Pfizer mineralo- corticoids, stimulant laxatives), anticholinergics, roxithromycin. 2NT A Arrhythmias, intra&ndash@rdiac Phosphodiesterase type 5 inhibitor. Sildenafil (as citrate) 20mg. White, round, biconvex film-ctd tab. conduction abnormalities, anticholinergic effects marked PFIZER on one side and RVT 20 on reverse. (dysuria, acute urinary retention, diplopia, accommodation disorders, GI disorders, impotence, 90, A553.95. psychiatric disorders). S Pulmonary arterial hypertension classified as WHO functional class III, to improve SOTACOR BMS exercise capacity. 3MO P 1 three times a day, approx. 6-8 hours Non-cardioselective b-blocker. Sotalol (HCl) 80mg, apart. 160mg. Both white tabs. scored on one side and Q Under 18 years, not recommended. tab. strength marked on other side. 80mg-28, D Severe hepatic impairment; recent A1.60; 160mg-28, A3.16. stroke or MI, severe hypotension (BPQ90/ S Prevention of myocardial infarction. 50mmHg) at initiation; Retinitis pigmentosa; loss Cardiac arrhythmias. Angina. Hypertension. of vision in one eye because of non-arteritic P Reinfarction: 320mg once daily, starting anterior ischaemic optic neuropathy (NAION). 5-14 days after infarction. Arrhythmias: Initial dose Lactation, pregnancy (unless strictly necessary). 80mg either singly or as 2 divided doses. Allow 2-3 B Caution: Hypotension, fluid depletion, days between increments. Most respond to dose severe LV outflow obstruction, autonomic of 160-320mg admin. in 2 divided doses at 12 hr dysfunction; penis deformation, condition intervals. In renal impairment; cc q60ml/min: predisposing to priapism; bleeding disorders, Normal dose; cc 30-60ml/min: Half normal dose; cc peptic ulceration. Signs of pulmonary oedema; 10-30ml/min: Quarter normal dose; cc Q10ml/min: potential for veno-occlusive disease. Contains Avoid. lactose. Withdraw gradually. Q Not recommended. C Contra: Potent CYP3A4 inhibitors (eg. ketoconazole, itraconazole, ritonavir), nitric oxide D See 2.4, b-blockers Drug Presc. Notes. Prolonged QT interval, torsades de pointes, renal donors (eg. amyl nitrite), nitrates, nicorandil. failure. Caution: Other CYP3A4 inhibitors, CYP3A4 B Caution: Pre-existing arrhythmias, QT substrates/ inducers, a-blockers. Bosentan, interval q 550msec. Electrolyte disturbances esp. epoprostenol, iloprost, other PDE5 inhibitors (no hypokalaemia or hypomagnesaemia. Caution: Left data). A Headache, flushing, limb pain, myalgia, ventricular dysfunction, recent MI. See b-blockers Prescribing Notes. See 2.4, b-blockers Drug Presc. dyspepsia, diarrhoea, cough, epistaxis, insomnia, Notes. pyrexia, influenza, visual disturbances. hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile membranes and low-density lipoprotein apheresis with dextran sulphate. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness, headache, symptomatic hypotension, MI, cerebrovascular accident, chest pain, palpitations, rhythm disturbances, angina pectoris, impaired renal function, GI disorders, hypersensitivity reactions, cutaneous and mucosal reactions, vasculitis, muscle and joint pains, fever or eosinophilia, dry tickling cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss of appetite, depressed mood, feeling of anxiety, paraesthesiae, taste change/reduction/loss, muscle cramps, erectile impotence, reduced sexual desire, increased blood urea nitrogen and serum creatinine, deterioration of pre-existing proteinuria.
CIRCULATORY SYSTEM B Caution: Pre-existing arrhythmias, QT interval q 550msec. Electrolyte disturbances esp. hypokalaemia or hypomagnesaemia. Caution: Left ventricular dysfunction, recent MI. See 4.2 bblockers Drug Presc. Notes.
SUSCARD BUCCAL
Forest
2MO Nitrate. Glyceryl trinitrate 2mg, 3mg, 5mg. White sust.-release tabs. marked with tab. strength. 2mg100, A20.19; 3mg-100, A28.29; 5mg-100, A39.67. S Congestive heart failure. Place tab. high up between upper lip and gum and allow to disolve. P Initially 5mg three times daily. Q Not recommended. A Headache, flushes.
TAMBOCOR
Meda
2MO Class I antiarrhythmic. Flecainide acetate 50mg white tab. marked 3M, TR50; 100mg white scored tab. marked 3M, TR100. 50mg-60, A10.18;100mg60, A11.19. S AV nodal reciprocating tachycardia. Wolff-Parkinson-White syndrome. Paroxysmal atrial fibrillation and atrial flutter. Symptomatic life threatening or disabling sustained ventricular tachycardia. Premature ventricular contractions and/or non-sustained ventricular tachycardia not responding to other therapy. P Supraventricular arrhythmias: Initially 50mg twice daily; max. 300mg daily. Ventricular arrhythmias: Initially 100mg twice daily; max. 400mg daily. Reduce after 3-5 days to lowest dose required to maintain control. Q Under 18, not recommended.
2N
ALSO TAMBOCOR INJECTION Flecainide acetate 10mg/ml; amp. 5 x 15ml, A29.20. S Rapid control of ventricular tachyarrhythmias, AV nodal reciprocating tachycardia and Wolff-Parkinson White syndrome. D Cardiac failure, history of MI with asymptomatic ventricular arrhythmias, severe ischaemic heart disease, 2nd or 3rd degree AV block, sinus node disease in absence of pacemaker. B Correct electrolyte disturbances before admin. Pacemakers or temporary pacing electrodes. Renal or hepatic insufficiency; monitor plasma levels. Cardiac disease. Pregnancy. C Other antiarrhythmics, digoxin, bblockers, other cardiac depressants (verapamil), amiodarone, other Na+ channel blockers, fluoxetine, tricyclics, reboxetine, phenytoin, phenobarbital, carbamazepine, clozapine, diuretics, mizolastine, terfenadine, quinine, RYTHMODAN RETARD sanofi-aventis SOTOGER Gerard ritonavir, lopinavar, indinavir, cimetidine, bupropion. 2MO 3MO Class I antiarrhythmic. Disopyramide (as phos.) Non-cardioselective b-blocker. Sotalol (HCl) 80mg, A AV block, cardiac failure, chest pain, hypotension, MI, palpitation, nausea, abdominal 250mg. White prolonged-release circular film-ctd 160mg. White tabs. 80mg-28, A2.66; 160mg-28, pain, constipation, diarrhoea, flatulence, elevated A5.25. tab. marked 013 on one side and E on the other. liver enzymes, Hepatic dysfunction, dizziness, 56, A19.12. S Prophylaxis of and control of atrial visual disturbances, blood dyscrasias, dyspnoea, flutter and fibrilation. Suppression and prevention S Cardiac arrhythmias. depression, anxiety, insomnia, rashes, alopecia. of ventricular tachycardia. P 1 tab. twice daily (morning and P Initially 80mg once or twice daily; evening). TENORMIN AstraZeneca maintenance, 160 mg twice daily. Max 640mg Q Not recommended. 3MO daily. Dose titration under close medical D 2nd or 3rd degree AV block and sinus Cardioselective b-blocker. Atenolol 25mg, 50mg, supervision and ECG control. node disease in absence of pacemaker. Bundle 100mg. White, white, orange biconvex film-ctd branch block associated with 1st degree AV block. Q Not recommended. tabs. marked Tenormin 25, Tenormin 50, and Double block (left posterior or anterior hemiblock D See 2.4, b-blockers Drug Presc. Notes. Tenormin respectively. 100mg bisected on reverse. and RBBB). Pre-existing long QT. Severe sinus node Prolonged QT interval, torsades de pointes, renal 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, dysfunction. Severe heart failure, unless secondary failure.
30
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
A3.23.
Pregnancy. B Treatment should be initiated and monitored by experienced physician. Women of childbearing potential should practice reliable contraception. Monitor ALT/AST levels prior to and at monthly intervals during treatment. C Cyclosporin A, glibenclamide, warfarin, THELIN Encysive simvastatin, ketoconazole, digoxin. A Headache, upper RTI, nasopharyngitis, 2JT Endothelin A receptor antagonist. Sitaxentan (Na+) oedema, flushing, hypotension, abnormal hepatic function. 100mg. Cap. shaped yellow-orange film-ctd tab. marked T-100. 28, A2538.05. TRANTALOL Pinewood S Pulmonary arterial hypertension 3MO classified as WHO functional class III, to improve Cardioselective b-blocker. Atenolol 25mg, 50mg, exercise capacity. 100mg. White tabs. 25mg: Circular, flat, scored on P 1 once daily. Response should be seen one side. 50mg and 100mg: Biconvex, film-ctd, by week 12, sometimes week 24. marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mgQ Under 18 years, not recommended. 30, A3.90; 100mg-30, A5.50. D Mild to severe hepatic impairment. S Cardiac arrhythmias. Early intervention Elevated liver AST or/and ALT prior to treatment in acute MI. Long-term prophylaxis after recovery (q 3xULN). Lactation. Pregnancy (unless clearly from MI. necessary). B Monitor for signs of pulmonary oedema P Arrhythmias: 50-100mg as single daily (consider veno-occlusive disease). Monitor AST/ALT dose. MI: 50mg 15 mins orally and 12 hrs after IV levels prior to treatment and at monthly intervals dose. Then 100mg orally 12 hrs later once daily. Renal failure: Reduce dose (see SPC). (see SPC if elevations). Check Hb levels prior to Q Not recommended. treatment, after 1 and 3 months, and every 3 D See 2.4, b-blockers Drug Presc. Notes. months thereafter. Contains lactose. B Caution: Patients with poor cardiac C Contra: Ciclosporin A. Caution: reserve. Will reduce heart rate. Contains lactose Epoprostenol, sildenafil, iloprost, vitamin K (50mg and 100mg). See 2.4, b-blockers Drug Presc. antagonists (e.g. warfarin, acenocoumarol and fenprocoumon), OATP inhibitors (e.g. some statins, Notes. C See 2.4, b-blockers Drug Presc. Notes. proteinase inhibitors, tuberculostatics), oral A Precipitation of atrioventricular block, contraceptives, nifedipine, CYP2C9 substrates. purpura, thrombocytopenia, impotence. See 2.4, bA Headache, insomnia, dizziness, peripheral oedema, nasal congestion, epistaxis, GI blockers Drug Presc. Notes. disorders, flushing, muscle cramp, fatigue, INR TRITACE sanofi-aventis increased, prothrombin prolonged. S Cardiac arrhythmias. Early intervention in acute MI. Angina pectoris. Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
TRACLEER
2MO Actelion
2NT Endothelin receptor antagonist (ERA). Bosentan (monohydrate) 62.5mg, 125mg. Orange-white film-ctd tab. marked with strength. 62.5mg-56, A2538.00; 125mg-56, A2538.00. S Primary pulmonary arterial hypertension (PAH). PAH secondary to scleroderma without significant interstitial pulmonary disease. P Initially 62.5mg twice daily for 4 weeks increasing to maintenance 125-250mg twice daily morning and evening. Q Under 12 years, not recommended. D Moderate to severe hepatic impairment.
EDITORIAL INFORMATION The information published in the editorial listing in MIMS Ireland is based upon details supplied by the manufacturers.The Index lists preparations which are available on prescription in general practice.
ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.59; 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. S Adjunct to diuretics and where appropriate, digitalis in congestive heart failure. Post MI prevention of disease progression in patients with heart failure. Prevention of MI, stroke or cardiovascular death in patients with an increased cardiovascular risk who are already taking standard therapy and in type 2 diabetic patients with an increased cardiovascular risk. P CHF: initially 1.25mg once daily, then double dose at intervals of 1-2 weeks according to response; max. 10mg daily. Reduce dosage of any diuretics first. Initiate therapy under close medical supervision. Post MI: initiate in hospital between days 3-10 post-MI. Starting dose 2.5mg twice daily. After two days, increase to 5mg twice daily. If starting dose not tolerated, reduce to 1.25mg twice daily for two days. Then increase to 2.5mg twice daily. If necessary, increase to 5mg twice daily two days later. Withdraw if dose cannot be increased to 2.5mg twice daily. Usual maintenance dose 2.5- 5mg twice daily. Prevention of MI, stroke or cardiovascular death: the initial dose is 2.5mg once daily, the dose is gradually increased. It is recommended to double the dose after 1 week and after another three weeks increase to 10mg. Usual maintenance dose is 10mg. R No special dosage recommendations for elderly patients apart from general warning about patients with renal or hepatic insufficiency or CHF which may be common in elderly and concomitant use of diuretic drugs. Dose titrated according to
2.1
need for BP control. Q Not recommended. D History of angioneurotic oedema. Aortic stenosis, outflow obstruction. Pregnancy, lactation. Hypersensitivity to ramipril. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: reduce dose and assess renal function prior to and during treatment. Haemodialysis (avoid in patients dialysed with high flux membranes). Use with caution in surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, NSAIDs. A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.
UNIPHYLLIN CONTINUS Mundipharma
2MO Xanthine. Theophylline 200mg white cap. -shaped scored sust.-release tab. marked U200; 300mg white cap.-shaped scored sust.-release tab. marked U300; 400mg white cap.-shaped scored sust.release tab. marked NAPP U400 one side, UNIPHYLLIN on reverse. 200mg-56, A4.17; 300mg56, A6.38; 400mg-56, A8.72. S Cardiac asthma, congestive cardiac failure. P Less than 70kg and elderly, 200mg 12 hourly for 1 week, then 300mg 12 hourly or 600mg at night. Over 70kg, 200-300mg 12 hourly for 1 week, then 400mg 12 hourly or 800mg at night. Q Not recommended. D Hypersensitivity to xanthine group of drugs. Lactation. B Other cardiac disease; liver disease. Peptic ulceration. Pregnancy. C Cimetidine, erythromycin. b-adrenergic agonists, glucagon, ephedrine, ciprofloxacin, fluvoxamine, interferon, steroids, diuretics. See SPC. A Nausea, gastric irritation, headache, CNS stimulants.
VASCACE
Roche
2MO ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. White, yellow, red or brown oval film-ctd scored tabs. marked CIL and strength. 0.5mg-28, A5.02; 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, A18.79. S Chronic heart failure usually as adjunctive therapy with digitalis and/or diuretics. P Initially 0.5mg once daily under close supervision. Adjust according to response. Maintenance usually 1-2.5mg once daily. Max. 5mg once daily. Q Not recommended. D Ascites, aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction. Pregnancy, lactation. B Haemodialysis. Renal or hepatic impairment, CHF, salt or volume depletion, surgery, anaesthesia. C K+sparing diuretics, NSAIDs. A Headache, dizziness, fatigue, dyspepsia, nausea, rash, coughing. Rarely angioneurotic oedema and alterations in blood count.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
31
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
CIRCULATORY SYSTEM
100, A5.16; 120mg-100, A10.59. S Superventricular tachycardia. P 40-120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Uncompensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.
D Pregnancy, lactation. Renal artery stenosis, post kidney transplant. History of angioneurotic oedema. Aortic or mitral valve Platelet aggregation inhibitor. Iloprost 10mcg/ml stenosis, hypertrophic cardio-myopathy. Systolic BP (as iloprost trometamol). 2ml nebuliser sln in Q100mmHg before treatment initiation. amps. Price available on request. Permanent haemodialysis. Primary S Primary pulmonary hypertension, hyperaldosteronism. classified as NYHA functional class III, to improve B Diuretics (q80mg frusemide), exercise capacity and symptoms. hypovolaemia, hyponatraemia, hyperkalaemia. P 2.5mcg or 5mcg (as delivered at the Hypotension (first dose). Acute MI and cardiac mouthpiece of nebuliser) 6 to 9 times per day. Use failure (if unstable), renal impairment, high-dose with recommended nebulisers. vasodilator therapy. LDL-cholesterol apheresis. Q Under 18 years, no experience. Elderly. D Conditions increasing risk of C Diuretics incl. K+sparing, K+suppl., other haemorrhage (e.g. active peptic ulcers, trauma, VOLIBRIS GSK antihypertensives, analgesics/anti-inflammatories, intracranial haemorrhage). Severe CHD or unstable 2 T lithium, alcohol, anaesthetics, narcotics, hypnotics. angina, MI within last six months, decompensated Ambrisentan 5mg, 10mg. Resp. pale pink or deep Sympathomimetics, oral antidiabetic agents, cardiac failure if not under close medical insulin. pink, square or oval film-ctd tab. with GS on one supervision, severe arrhythmias, cerebrovascular A Hypotension, dizziness, fatigue, side and K2C or KE3 on the other. Prices on events (e.g. TIA, stroke) within last 3 months. arrhythmias. Proteinuria, dry cough, nausea request. Pulmonary hypertension due to venous occlusive (occasionally), abdominal pain, rash, headache. S Pulmonary arterial hypertension (PAH) disease. Congenital or acquired valvular defects WHO functional class II and III, to improve exercise with myocardial function disorders not related to ZESTAN Clonmel capacity. pulmonary hypertension. Pregnancy, lactation. 2MO P 5mg once daily. If well tolerated, may B Unstable pulmonary hypertension with ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. be increased to 10mg in WHO class III PAH advanced right HF (not recommended). Acute marked with strength and scored both sides; patients. Severe renal impairment: Initiate pulmonary infections (monitor). Systolic arterial 10mg, 20mg white tabs. marked with strength cautiously. hypotension Q85mmHg (not recommended). and quadrisected both sides. 2.5mg-28, A4.84; Q Under 18 years, not recommended. Hepatic dysfunction or renal failure requiring 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. D Pregnancy. Women of child-bearing dialysis. Caution with discontinuation. S Adjunct to diuretics and where potential not using reliable contraception. C Caution: Vasodilatators and appropriate, digitalis, in congestive heart failure. Lactation. Severe hepatic impairment. AST and/or antihypertensive agents, anticoagulants or other Treatment of acute MI in haemodynamically stable ALT q3xULN. inhibitors of platelet aggregation. patients. B Safety not established in WHO A Vasodilatation, hypotension, syncope, P CHF, initially 2.5mg once daily functional class I PAH. Evaluate ALT and AST prior increased cough, headache, trismus. increasing in intervals of 2-4 weeks to to initiation and monitor during treatment; VERAMIL Orion discontinue if clinically significant elevations occur maintenance of 5-20mg once daily. If possible or elevations with symptoms of hepatic injury. Not reduce dose of any diuretics first. Initiate therapy 2MO under close medical supervision (in hospital for recommended: Clinically significant anaemia. Class I Ca++ antagonist. Verapamil chlor. 40mg, severe or unstable HF or high risk patients). Post Regularly measure Hb and/or haematocrit levels. 80g, 120mg. White film-ctd tabs. coded VL-40, VL- Peripheral oedema may occur (increased frequency MI, initially 5mg followed by 5mg after 24 hrs, 80 and VL-120. 40mg-100, A5.17; 80mg-100, 10mg after 48 hrs, and then 10mg once daily. and severity over 65 years). Monthly pregnancy A8.67; 120mg-100, A11.56. tests recommended. Contains soya, lactose, Allura Q Not recommended. S Supraventricular tachycardias and D Angioneurotic oedema, severe renal red AC. prevention of recurrence. impairment, haemodynamically unstable patients C Caution: Cyclosporine A, other PAH P 40-120mg three to four times daily. after MI, haemodynamically relevant aortic or treatments (e.g. prostanoids, PDE-5 inhibitors). Severe liver dysfunction: Use 1/3 dose. mitral valve stenosis or hypertrophic A Palpitation, anaemia, headache, upper D Severe left ventricular dysfunction. cardiomyopathy, systolic BP R 100 mmHg before respiratory congestion, sinusitis, nasopharyngitis, Severe hypotension, cardiogenic shock. 2nd or 3rd rhinitis, GI disorders, flushing, peripheral oedema, initiation of treatment, cardiogenic shock. degree AV block. Marked bradycardia. Sick sinus B Haemodialysis. Hypotension, syndrome. CHF incl. including uncompensated HF. fluid retention. renovascular hypertension, renal impairment, Lactation. ZESGER Gerard monitor renal function before and during B 1st degree AV block reported. treatment, severe CHF, primary Hypertrophic cardiomyopathy, elderly, attenuated 2 M O neuromuscular transmission. Mild to moderate HF ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. hyperaldosteronism, aortic stenosis, hypertrophic cardiomyopathy. Low-density apheresis/ Round, flat beveled edge, square biconvex and (control with digitalis and diuretics). Porphyria desensitisation therapy. (unsafe). Hepatic impairment (monitor during pentagonal biconvex tabs. debossed on one side C Diuretics, K+ sparing diuretics, K+ suppl., long-term therapy). Contains lactose. Pregnancy. with 2.5, 5, 10 and 20 resp. All white with A C Grapefruit juice, digitalis intoxication, IV breakline on other side. 2.5mg-28, 5.38; 5mg-28, Na+ Cl, lithium, anti-hypertensives, analgesics, anti-inflammatories, alcohol, anaesthetics, b-blockers (contra). Colchicine, cisapride (avoid). a/ A7.59; 10mg-28, A9.37; 20mg-28, A10.75. b-blockers, CYP3A4 inhibitors/substrates, S Heart failure as additive therapy to non- narcotics, hypnotics, sympathomimetics, oral antidiabetics, insulin, antacids, NSAIDs. antiarrhythmics, CCBs, cardiac glycosides, K+sparing diuretics, and digitalis (where A Hypotension, angioedema, dizziness, theophylline, imipramine, glyburide, doxorubicin, appropriate). Acute MI in haemodynamically weakness, impaired vision, renal dysfunction, dry paclitaxel, tamoxifen, cimetidine, statins, stable patients, in addition to usual standard cough, sore throat, hoarseness, bronchitis, GI almotriptan, halothane, dantrolene, Ca++ salts, therapy in MI, especially together with nitrates. disturbances, rash, headache, tiredness. alcohol, lithium, timolol eye drop, quinidine, P Initially 2.5mg in the morning. antihypertensives. Maintenance dose titrated by 2.5mg increments ZESTRIL AstraZeneca A Constipation, headache, dizziness, according to patient response. Time interval fatigue, rash, bradycardia, hypotension, cardiac 2MO between dose increases q2 weeks but preferably insufficiency, swelling of ankles. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. 4 weeks; max. 35mg daily. Post MI: initially 5mg, then 5mg after 24hours, 10mg after 48 hours and White, pink, pink, red tabs. resp. marked with VERISOP Gerard thereafter 10mg once daily. Low systolic BP: heart shape, strength and ZESTRIL. 2.5mg-28, 2MO initially 2.5mg. Hypotension: max. daily dose 5mg, A3.23; 5mg-28, A4.56; 10mg-28, A5.63. 20mg-28, A6.46. with reduction to 2.5mg if necessary. If Class I Ca++ antagonist. Verapamil chlor. 40mg, S Adjunctive therapy in congestive heart hypotension persists on 2.5mg, discontinue. 80g, 120mg. White tabs. marked VL and strength one side, G on reverse. 40mg-100, A3.53; 80mgfailure with non-potassium sparing diuretics with Q Not recommended.
VENTAVIS
Bayer Schering
2NT
32
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM or without digitalis. Acute myocardial infarction. P CHF: Initially 2.5mg once daily increasing gradually to 5-20mg once daily, according to response. Reduce dose of any diuretic first. Acute MI: First dose is 5mg, followed by 5mg after 24 hours, 10mg after 48 hours and then 10mg once daily. Q Not recommended. D History of angioneurotic oedema. Not recommended: Lactation, pregnancy (contra 2nd3rd trim.). B Renal impairment; monitor renal function before and during treatment. Aortic stenosis, cor pulmonale, outflow tract obstruction. 1st dose hypotension. Anaphylactoid reactions (during haemodialysis using high flux membranes, LDL apheresis, desensitisation). C K+ sparing diuretics, K+ suppl., other antihypertensives, indomethacin, lithium, injectable gold. A Dizziness, headache, fatigue, diarrhoea, cough, rash, asthenia, angioedema, renal failure. Hypotension, palpitations, chest pain, impotence.
ANGINA 2.2 90, A3.03; 10mg-90, A3.85. P Initially 5mg eight hourly adjusted according to response, increasing to max. 20mg every 8 hrs. Q Not recommended. D Women of child-bearing potential, lactation. Cardiogenic shock, aortic stenosis. Acute angina attacks, unstable angina pectoris, during or within one month of MI. Adalat LA only: Hepatic impairment, history of GI obstruction, IBD, Crohn’s disease. B Poor cardiac reserve, HF, hepatic impairment, severe hypotension. Diabetes, dialysis. Severe GI narrowing. Elderly. Driving/using machines. Postural hypertension, syncope, tachycardia reported. C Contra: Rifampicin. Avoid grapefruit juice. Caution: Antihypertensive agents, cimetidine, quinidine, digoxin, phenytoin, diltiazem, cisapride, quinupristin/dalfopristin, CYP3A4 inhibitors. A Headache, vasodilatation, palpitation, nausea, dizziness, oedema. Lethargy, asthenia, constipation.
within 2-4 weeks, may be increased to max. 10mg once daily. May be used as monotherapy or in combination with other antianginal drugs. Q Under 12 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.
AMLIST
Gerard
2MO
Ca antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round tab. 10mg with break score on both sides. 5mg-28, A9.20; 10mg28, A13.75. S Chronic stable and vasospastic angina ZOFENIL A. Menarini ADIZEM XL CAPSULES Mundipharma pectoris. 2MO P 5mg once daily with water. If no effect 2MO within 2-4 weeks, may be increased to max. 10mg Cardioprotective ACE inhibitor. Zofenopril 7.5mg. ++ A once daily. May be used as monotherapy or in White film-ctd. tab. 12, 2.91. Class III Ca antagonist. Diltiazem (HCl) 120mg combination with other antianginal drugs. S Post acute MI, with or without heart pink/blue cap.; 180mg pink/blue cap.; 240mg red/ Q Under 18 years, not recommended. failure if haemodynamically stable and not on blue cap.; 300mg maroon/blue cap. All cont.D Severe hypotension, shock, HF after antithrombolytic therapy. release caps. marked with DCR and strength. A A acute MI (during 1st 28 days), obstruction of P First and second day, 7.5mg 12 hourly, 120mg-28, 8.40; 180mg-28, 12.45; 240mg-28 A16.05; 300mg-28, A12.42. outflow tract of left ventricle (e.g. high grade third and fourth day, 15mg 12 hourly, increasing aortic stenosis), unstable angina pectoris. S Angina. on fifth day to 30mg 12 hourly. Pregnancy (unless essential), lactation. R Use with caution in those over 75 years. P Initially 240mg once daily adjusting according to response. Caps. should be swallowed B Low cardiac reserve, cardiac failure, Q Not recommended. hepatic impairment, elderly. Contains lactose. whole. D Angioneurotic oedema, severe hepatic R Initially 120mg once daily and carefully Driving or using machines. impairment, renal artery stenosis. Pregnancy, C Caution: CYP3A4 inhibitors/ inducers, lactation. Women of child-bearing potenial unless titrate as required. other antihypertensives incl. b-blockers. Q Not recommended. protected by effective contraception. A Ankle swelling. Headache, fatigue, 2 M O B Reduce dosage of diuretic if possible dizziness, asthenia, palpitations, flushing, nausea, before initiating therap. Volume depletion may ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg dyspepsia, abdominal pain. cause sympathetic hypotension, dialysis, white cap.; 120mg brown/white cap.; 180mg anaesthesia, renal or heptic impairment. brown/white cap. All cont. -release caps. marked AMLODE Rowex C Other anti-hypertensive agents, with strength. 90mg-56, A12.80; 120mg-56, A14.21; 180mg-56, A21.32. 2MO diuretics, lithium, K+sparing diuretics, K+suppl., NSAIDs. P Initially 90mg twice daily. Increase Ca++ antagonist. Amlodipine 5mg, 10mg (as A Dizziness, fatigue, headache, cough, gradually to 120mg or 180mg twice daily as amlodipine besilate). White oblong, bevelled tab. nausea, vomiting, rash, muscle cramp, weakness. required. scored on one side and marked with strength on R Start at lowest level of 90mg twice reverse. 5mg-28, A8.33; 10mg-28, A12.50. 2.2 ANGINA daily; carefully titrate as required. S Chronic stable and vasospastic angina Q Not recommended. pectoris. ADALAT LA Bayer Schering D Pregnancy, lactation. Sick sinus P 5mg once daily with water. If no 2MO syndrome, 2nd or 3rd degree AV block, marked sufficient effect within 2-4 weeks, may be ++ bradycardia, decompensated cardiac failure. increased to 10mg daily (as single dose). Class II Ca antagonist. Nifedipine 20mg, 30mg, 60mg. Pink modified-release tab. marked ADALAT B Mild bradycardia, prolonged PR interval. Q Under 18 years, not recommended. D Hypersensitivity to dihydropyridine 20, ADALAT 30 and ADALAT 60. 20mg-28, A9.21; Measure heart rate regularly in elderly and in patients with hepatic or renal impairment. derivatives. Severe hypotension, shock, HF after 30mg-28, A11.85; 60mg-28, A17.61. Diabetes. acute MI (during 1st 28 days), obstruction of S Chronic stable angina pectoris. C b-blockers, digoxin, cimetidine, outflow-tract of left ventricle (e.g. high grade P Initially 30mg once daily in the diazepam, antihypertensives, anaesthetics, aortic stenosis), unstable angina pectoris. morning. Increase if necessary up to max. 90mg dantrolene inf. Pregnancy (unless essential), lactation. once daily. Tabs. must be swallowed whole with A Anorexia, nausea, bradycardia, oedema, B Hepatic impairment, cardiac failure, low water. rash, flushing, fatigue, AV block. cardiac reserve, elderly. Q Not recommended. C Caution: CYP3A4 inhibitors/inducers. 2MO Pinewood Other antihypertensives (e.g. a/b blockers, ACEALSO ADALAT RETARD 10 Nifedipine 10mg. Pink- AMLID inhibitors, diuretics). 2MO grey tab. marked A10 one side, Bayer cross on A Ankle swelling, headache, facial reverse. 10mg-56, A9.72; 20mg-56, A11.87 Ca++ antagonist. Amlodipine 5mg, 10mg (as flushing, dizziness, fatigue, asthenia, palpitations, P Initially 10mg twelve hourly adjusting to amlodipine maleate). White round biconvex tab. abdominal pain, nausea, dyspepsia. response, increasing to 40mg every 12 hours. A 10mg tab. scored on both sides. 5mg-28, 9.19; Q Not recommended. 10mg-28, A13.70. AMLOTAN Clonmel 2MO S Chronic stable and vasospastic angina 2MO ALSO ADALAT Nifedipine 5mg, 10mg. Orange, pectoris. gelatin ovoid caps. containing yellow fluid. 5mgP 5mg once daily with water. If no effect Ca++ antagonist. Amlodipine 5mg, 10mg (as ++
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
33
2.2 ANGINA
CIRCULATORY SYSTEM
amlodipine mesilate monohydrate). White round biconvex tab embossed with 5 or 10 resp. 10mg tab. scored. 5mg-28, A7.34; 10mg-28, A10.97. S Chronic stable and vasospastic angina pectoris. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.
ATENOGEN
Antigen
3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange film-ctd tabs. marked AT/25, AT/50, AT/100, resp. All marked with maker’s symbol. 25mg-28, A2.49; 50mg-28, A3.77; 100mg-28, A5.38. S Cardiac arrhythmias. Long-term prophylaxis after recovery from acute MI. Angina pectoris. Essential hypertension. P Arrythmias: 50-100mg daily. Prophylaxis after recovery from MI: 100mg daily. Hypertension: 50mg daily increasing to 100mg daily if required. Allow time to achieve full effects (1-2 weeks) before determining need to increase to 100mg daily. Angina: 100mg daily as a single dose or as 50mg twice daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
240mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
BETALOC
AstraZeneca
3MO Cardioselective b-blocker. Metoprolol tartrate. 50mg white tab. scored and marked A/BB one side; 100mg white tab. scored and marked A/ME one side. 50mg-100, A2.11; 100mg-100, A3.91. S Angina. P 50-100mg twice or three times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
BISOCOR
Niche
3MO
Cardioselective b-blocker. Bisoprolol hemifumarate 5mg, 10mg. Pale-yellow scored tab. marked BI and 5, beige scored tab. marked BI and 10. 5mg-28, ATENOMEL Clonmel A5.28. 10mg-28, A5.99. S Chronic stable angina. AMOLIN Ergha 3 M O P Usually 10mg once daily. Max. 20mg Cardioselective b-blocker. Atenolol 25mg, 50mg, daily. 3MO 100mg. White tab. marked C23, C24, C25. 50 and Q Not recommended. Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; D See 2.4, b-blockers Drug Presc. Notes. 100mg. White film-ctd tabs. marked C23, C24 and 100mg-30, A5.01. Acute HF or during episodes of HF C25 resp. 25mg-30, A1.56; 50mg-30, A2.36; S Angina pectoris. decompensation requiring IV inotropic therapy. 100mg-30, A3.10. P 50-100mg daily. S Angina pectoris. Q Not recommended. BISOP Rowex P 50-100mg daily. D See 2.4, b-blockers Drug Presc. Notes. 3MO Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. BETA-ADALAT Bayer Schering Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Resp. yellow or apricot, round film-ctd 3MO tablet with a cross score encoded BIS and strength ATECOR Rowex Cardioselective b-blocker/class II Ca++ antagonist. on one side. 5mg-28, A5.34;10mg-28, A6.01. 3MO Atenolol 50mg, slow release nifedipine 20mg. S Angina pectoris. Reddish-brown cap. marked with name and Bayer Cardioselective b-blocker. Atenolol 25mg, 50mg, P Should be taken with liquid (not cross. 28 (Cal/Pk), A11.87. 100mg. White scored film-ctd tabs. 25mg-30, chewed), in the morning. Initially 5mg; usual dose S Chronic stable angina pectoris, where b 10mg once daily; max 20mg/day. A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, -blocker or calcium antagonist monotherapy is A5.77; 100, A18.67. Q Not recommended. inadequate. S Angina pectoris. D Acute HF or during episodes of HF P 1 every 12 hours. If necessary P 100mg once daily or 50mg twice daily. decompensation requiring IV inotropic therapy. prophylactic nitrate therapy or additional Q Not recommended. Cardiogenic shock. AV block of 2nd or 3rd degree nifedipine may be given. D See 2.4, b-blockers Drug Presc. Notes. (without a pacemaker). Sick sinus syndrome. Q Not recommended. Sinoatrial block. Bradycardia (Q 60 beats/min) ATENI Gerard D Women of child bearing potential. HF. before start of therapy. Hypotension (systolic BP 2nd or 3rd degree heart block. Cardiogenic shock, Q 100mmHg). Severe bronchial asthma or severe 3MO use in conjunction with other cardio-depressant COPD. Late stages of peripheral arterial occlusive Cardioselective b-blocker. Atenolol 50mg, 100mg drugs, severe bradycardia, acute angina attacks, disease and Raynaud’s syndrome. Untreated white tabs. Both marked AT and strength one unstable angina pectoris, severe aortic stenosis, phaeochromocytoma. Metabolic acidosis. side, G on reverse. 50mg-28, A4.16; 100mg-28, during or within one month of MI, wheezing, Pregnancy (unless necessary), lactation. A5.38. asthma, severe renal failure. Pregnancy, lactation. B Regular monitoring required. Withdraw S Angina pectoris. B Cardiac conduction defects or poor gradually. Caution: Bronchospasm, diabetes P 100mg once daily or 50mg twice daily. cardiac reserve. OAD. Renal or hepatic mellitus with large fluctuations in blood glucose Q Not recommended. impairment. Diabetes. Anaesthesia. Elderly. (hypoglycaemia symptoms can be masked), strict D See 2.4, b-blockers Drug Presc. Notes. C Antihypertensives, cimetidine, quinidine, fasting, ongoing desensitisation therapy, AV block rifampicin, digoxin, cardiodepressants, adrenergic- of 1st degree, Prinzmetal’s angina, peripheral neurone blocking drugs, non-cardio-selective barterial occlusive disease, general anaesthesia. In blockers, grapefruit juice. bronchial asthma or other COPD, bronchodilating A Flushing, headache, fatigue, dizziness, therapy should be given concomitantly. Psoriasis: dry eyes, skin rash, oedema, hypersensitivity type Assess risk/benefit. Phaeochromocytoma: Do not jaundice (rare), gingival hyperplasia, This medicinal product admin. until after a-receptor blockade. Symptoms gynaecomastia, impotence. Mood changes, MI, of thyrotoxicosis may be masked. Contains lactose. contains substance(s) ischaemic pain (discontinue). Driving/operating machinery ability (at start of prohibited for use in specific treatment, with alcohol). BETA-PROGRANE Tillomed C Contra: Floctafenin, sultopride. Not sports only (as listed in 3MO recommended: Ca++ antagonists (verapamil type WADA Prohibited List 2010). Non-cardioselective b-blocker. Propranolol (HCl) and diltiazem type), class I antiarrhythmics, Athletes requesting to use 80mg, 160mg. White hard prolonged.-release cap. centrally acting antihypertensives. Caution: Ca++ A 8.13; 80mg (HALF BETA-PROGRANE)- (dihydropyridine type (e.g. felodipine, this product in these specific 160mg-28, 28, A6.27. amlodipine), class-III antiarrhythmics (e.g. sports are required to apply S Angina. amiodarone), topical b-blocking agents (e.g. eye P 80mg every morning or evening; may drops for glaucoma treatment), for a TUE. be increased if necessary to 160mg daily up to parasympathomimetics, insulin and oral
Anti-Doping Information
s
34
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM antidiabetics, anaesthetic agents, digitalis glycosides, NSAIDs, b-sympathomimetics that activate both b and a-adrenoreceptors (e.g. noradrenaline, adrenaline), antihypertensives, tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAOB inhibitors). A Bradycardia, worsening of heart failure, dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, asthenia, fatigue.
ANGINA 2.2 Q Not recommended.
2MO
ALSO DILZEM SR Diltiazem (HCl) 60mg, 90mg, 120mg. Prolonged release hard capsules marked with cap.strength. 60mg-56, A8.12; 90mg-56, A12.16; 120mg-56, A13.90. P Initially 90mg twice daily, increasing gradually to 180mg twice daily. R Initially 60mg twice daily increasing gradually. Q Not recommended. D Pregnancy, lactation, women of child BISOPINE Pinewood bearing potential. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, 3MO Cardioselective b-blocker. Bisoprolol hemifumarate decompensated cardiac failure. Atrial fibrillation/ flutter with WPW. Concomitant dantrolene 5mg, 10mg. Resp. pale yellow or beige mottled infusion. tabs. marked BI above breakline 5 or 10 below. B Mild bradycardia, prolonged PR interval, 5mg-28, A5.90; 10mg-28, A6.65. diabetes, red. LV function, monitor patients with S Chronic stable angina pectoris. hepatic dysfunction and renal impairment. P Usually 10mg once daily; max. 20mg C Antihypertensives, halogenated daily. Upon discontinutation, diminish slowly by anaesthetics, H2 agonists, digoxin. weekly halving dose. Severe renal impairment: A Oedema, headache, dizziness, asthenia, Max dose 10mg daily bradycardia, flushing, 1st degree heart block. R Lowest dose recommended. Regular monitoring during treatment initiation. ELANTAN LA UCB Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. 2MO Acute HF or during episodes of HF Nitrate. Isosorbide mononitrate 25mg brown/white decompensation requiring IV inotropic therapy. sust.-release cap., 50mg brown/flesh sust.-release Combinations with floctafenine and sultopride. cap. 25mg-28 (Cal/Pk), A7.63; 50mg-28 (Cal/Pk), B See 2.4, b-blockers Drug Presc. Notes. A13.12. Iodated contrast products. Driving/operating S Prophylaxis of angina pectoris. machinery. Contains lactose. P 25-50mg in the morning swallowed C See 2.4, b-blockers Drug Presc. Notes. whole. Anti-cholinesterastic drugs. Amifostine. NSAID. Q Not recommended. A See 2.4, b-blockers Drug Presc. Notes. 2MO Headache. ALSO ELANTAN Isosorbide mononitrate 10mg, 20mg, 40mg. White scored tabs. marked E10, E20 DILTAM RETARD Rowex or E40. 10mg-56, A4.43; 10mg-84, A6.64; 20mg2MO 56, A5.64; 20mg-84, A8.00; 40mg-56, A9.20; 40mg-84, A13.77. Class III Ca++ antagonist. Diltiazem (HCl) 90mg. A P Initial dosage for patients not already White sust.-release tab. 60, 12.38. receiving prophylactic nitrate therapy, 10mg twice S Angina pectoris incl. Prinzmetal’s daily, dose may be increased to 10mg three times angina. daily. Others, 40-80mg daily in two or three P Initially 60mg twice daily increasing to divided doses after meals. Max. 120mg daily. 90mg twice daily. Q Not recommended. R Initially 60mg twice daily increasing D Acute MI and cardiac shock. Severe gradually. hypotension. Q Not recommended. C Alcohol. D Pregnancy, lactation. Sick sinus A Headache, flushes, dizziness. syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. Gerard B Mild bradycardia, prolonged PR interval. EMCOLOL Measure heart rate regularly in elderly and in 3O patients with hepatic or renal impairment. Cardioprotective b-blocker. Bisoprolol fumarate Diabetes. 5mg and 10mg. Yellow and orange heart-shaped, C b-blockers, digoxin, cimetidine, scored film-ctd tabs. resp. 5mg-28, A5.93; 10mgdiazepam, antihypertensives, anaesthetics. 28, A6.65. A Anorexia, nausea, bradycardia, oedema, S Angina pectoris rash, flushing, fatigue, AV block, headache, GI P Usually 10mg once daily. Max. 20mg disturbance. daily. Q Not recommended. DILZEM XL Cephalon D See 2.4, b-blockers Drug Presc. Notes.
2MO Class III Ca++ antagonist. Diltiazem (HCl) 120mg, 180mg, 240mg. Prolonged release hard capsules marked with cap. strength and logo. 120mg-28, A8.39; 180mg-28, A12.44; 240mg-28, A16.06. S Angina pectoris, incl. Prinzmetal’s angina. Mild to moderate hypertension. P 180mg once daily increasing gradually, as necessary to 360mg once daily. R Initially 120mg once daily, increasing gradually.
function: Max. 10mg once daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.
ENTRYDIL
Orion
2MO Class III Ca++ antagonist. Diltiazem 60mg. White film-ctd scored caplet coded DL60. 100, A17.16. S Angina pectoris. P Usually 1 three times daily, increasing if necessary to up to 8 daily in divided doses. R Initially 1 twice daily. Q Not recommended.
2MO ALSO ENTRYDIL CR Diltiazem 90mg, 120mg. Modified release white scored film-ctd caplets marked DL 90 or DL 120. 90mg-100, A21.53; 120mg-100, A35.60. P Usually 90-120mg twice daily increasing to 180-240mg twice daily if necessary. Q Not recommended. D Pregnancy. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. B Mild bradycardia, prolonged PR interval. Measure heart rate regularly in elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Anorexia, nausea, bradycardia, oedema, rash, flushing
EUCARDIC
Roche
3MO a/b-blocker. Carvedilol 12.5mg, 25mg. Resp. light brown or pale beige round scored tab. marked BM on one side and H3 or D5 on other side. 12.5mg-28, A4.78; 25mg-28, A5.72. S Long-term management of stable angina pectoris. P Initially, 12.5mg twice daily for first 2 days. then 25mg twice daily. If necessary titrate at 2 week interval up to 50mg twice daily. R Max. 50mg daily in divided doses. Q Under 18 years, not recomended. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction. Contains lactose.
GLYTRIN SPRAY
Pharmasol
2MO
Nitrate. Glyceryl trinitrate 0.4mg/metered dose. CFC-free spray. 200 dose unit, A3.89. S Treatment and prophylaxis of angina pectoris and treatment of variant angina. P 1-2 doses as required for relief of angina pain or for short-term prophylaxis before exercise. Max. 3 doses per angina attack. All by sublingual admin. Q Not recommended. D Hypotensive disorders incl. shock, severe anaemia, cerebral haemorrhage and brain trauma, EMCOR Daiichi Sankyo/Merck Serono mitral stenosis, angina caused by hypertrophic obstructive cardiomyopathy. 3MO C Alcohol. Cross tolerance to other Cardioselective b-blocker. Bisoprolol fumarate nitrates. 5mg, 10mg. Yellow and orange biconvex film-ctd A Headache, flushing, postural heart-shaped scored tabs. 5mg-28, A3.56; 10mghypotension, tachycardia and paradoxical A 28, 4.01. bradycardia. S Angina pectoris. P Usually 10mg once daily; max. 20mg IKOREL sanofi-aventis daily. In some 5mg/day may be adequate. Final 2MO stage impairment of renal function or liver
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
35
2.2 ANGINA
CIRCULATORY SYSTEM
Potassium channel opener. Nicorandil 10mg, 20mg. White scored tabs. marked IK10 or IK20. 10mg-60, A12.84; 20mg-60, A22.73. S Prevention and management of angina pectoris. P Initially: 10mg twice daily. Titrate according to response. Maintenance: 10-20mg twice daily; max. 40mg twice daily. Patients susceptible to headache, initially 5mg daily. Q Not recommended. D Cardiogenic shock with depleted blood volume, hypotension, LV failure with low filling pressure or acute pulmonary oedema and myocardial infarction. Pregnancy, lactation. C Antihypertensive drugs, TCADs. A Headache, flushing, nausea, dizziness, hypotension and tachycardia.
Q Not recommended. D Uncompensated cardiac shock. Severe hypotension. Marked anaemia. Cerebral haemorrhage. A Headache, flushes, dizziness.
ISOMEL SR 60 2MO
nausea, palpitations, fatigue, abdominal pain, somnolence.
ISTOLDE
Actavis
2MO Ca++ antagonist. Amlodipine 5mg, 10mg. White,
Clonmel uncoated, round, flat, tab. with score on one side,
Nitrate. Isosorbide mononitrate 60mg. Yellow oval film-ctd modified release tab. scored on both sides and marked IM60. 28, A9.95. S Prophylaxis of angina. P 1 daily in the morning, increasing if necessary to max. 2 once daily. Q Not recommended. D Severe cerebrovascular insufficiency, hypotension. Pregnancy, lactation. B Not indicated for acute angina attacks. IMDUR AstraZeneca C Alcohol, NA, acetylcholine, histamine, 2MO anti-hypertensives. Nitrate. Isosorbide mononitrate 60mg. Yellow oval A Headache, hypotension, dizziness, film-ctd sust.-release tab. scored and marked A/ID. nausea. 28, A6.36. ISOMONIT RETARD Rowex S Prophylaxis of angina. P 1 daily in the morning, increasing if 2MO necessary to max. 2 once daily. Nitrate. Isosorbide mononitrate 60mg. White Q Not recommended. scored prolonged release tab. 30, A10.79. D Acute myocardial infarction, anaemia, S Prophylaxis of angina. head trauma, cerebral haemorrhage, severe P 1 daily in the morning, increasing if hypotension, cerebrovascular insufficiency. necessary to max. 2 once daily. Pregnancy, lactation. Q Not recommended. B Closed angle glaucoma. Hypothyroidism, D Acute myocardial infarction with low malnutrition, severe renal or hepatic disease. filling pressure, circulatory failure, marked C Alcohol. anaemia, head trauma, cerebral haemorrhage, A Headache, dizziness, nausea, severe hypotension, hypovolaemia, severe hypotension, collapse. cerebrovascular insufficiency. B Closed angle glaucoma. Hypothyroidism, INDERAL LA AstraZeneca malnutrition, severe renal or hepatic disease. 3MO C Alcohol. Non-cardioselective b-antagonist. Propranolol (HCl) A Headache, dizziness, nausea, hypotension, collapse. 160mg. Lavender/pink hard prolong.-release cap. marked INDERAL LA. 28, A8.41.
embossed with AB5 or AB10 on the other. 5mg28, A8.54; 10mg-28, A12.71. S Chronic stable and vasospastic angina pectoris. P Initially 5mg once daily. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. As monotherapy or in combination with anti-anginal medication. R Caution when increasing dose. Q Under 18 years, not recommended. D Severe hypotension. Shock (incl. cardiogenic). Heart failure after acute MI (first 28 days). High-grade aortic stenosis. Unstable angina pectoris. Pregnancy, lactation. B Caution: Cardiac failure, hypertensive crisis (safety and efficacy not established), dialysis, hepatic impairment, heart failure (increased incidence of pulmonary oedema in NYHA class III and IV). C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives. A Headache, somnolence, dizziness, weakness, palpitations, GI disorders, ankle oedema, facial flushing with heat sensation.
METOCOR
Rowex
3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg100, A3.50; 100mg-100, A6.50. S Angina. P 50-100mg twice or three times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
3MO
ISOPTIN
ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. Lavender/pink hard prolong.-release cap. marked HALF-INDERAL LA. 28, A6.13. S Angina. P 80mg or 160mg daily. Max. 240mg daily. Q Not recommended.
2MO
3MO
Class I Ca++ antagonist. Verapamil (HCl) 40mg, 80mg, 120mg. White film-ctd tabs. 40mg-100, A2.12; 80mg-100, A4.24; 120mg-100, A6.36. S Angina. P 120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Unconpensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of myocardial infarction. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.
Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; 100mg-100, A6.51. S Angina. P 50mg twice daily or 100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
3MO ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, A1.20. S Angina pectoris. P Initially 40mg two or three times daily increasing as necessary at weekly intervals; usual dose 120-240mg daily. Q Up to 1mg/kg body weight three or four times daily. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.
Abbott
METOP
Gerard
MYOSTIN
Teva
2MO
Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White, round, tab. scored on one side. 5mg-28, A8.28; 10mg-28, A12.38. S Chronic stable and vasospastic angina pectoris as monotherapy or in combination with ISTIN Pfizer other antianginal drugs. 2MO P 5mg once daily. If no sufficient effect within 2-4 weeks, may be increased to max. 10mg Ca++ antagonist. Amlodipine besylate 5mg, 10mg. ISOKET 0.1% UCB once daily. White emerald-shaped tabs. marked AML-5 or 2N Q Under 18 years, not recommended. AML-10 resp. and Pfizer on reverse. 5mg-28, A5.53; 10mg-28, A8.26. Nitrate. Isosorbide dinitrate 1mg/ml. Soln. Amps.D Severe hypotension, shock, HF after 10 x 10ml, A59.11; Bottles-50ml, A29.33; 100ml, acute MI (during 1st 28 days), obstruction of S Prophylaxis of angina pectoris A40.50. outflow-tract of left ventricle, unstable angina associated with myocardial ischaemia. 2N pectoris. Lactation, pregnancy (unless clearly P Initially 5mg daily increasing to max. necessary). 10mg. ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ A B Low cardiac reserve, hepatic Q Not recommended. ml. 50ml, 15.69. impairment, cardiac failure, elderly; caution. B Impaired liver function. Pregnancy, S Severe or unstable angina pectoris. Driving/using machines. P 2-10mg/hour adjusting according to lactation. C Caution: CYP3A4 inhibitors/inducers, response. Max. 20mg/hour. A Oedema, headache, flushing, dizziness,
36
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
ANGINA 2.2
other antihypertensives incl. b-blockers. A Ankle swelling, headache, dizziness, fatigue, asthenia, palpitations, dyspnoea, abdominal pain, nausea, dyspepsia, flushing.
NIFED
Rowex
2MO Class II Ca antagonist. Nifedipine 10mg. Oblong brown caps. 100, A7.01. S Acute and chronic coronary insufficiency in particular angina pectoris. P 30-60mg daily in divided doses. R 15mg in divided doses. Q Not recommended. ++
2MO ALSO NIFED RETARD Nifedipine 10mg, 20mg. Pink film-ctd modified-release tabs. 10mg-60, A8.08; 20mg-100, A18.16. P Initially 10mg twelve hourly, increasing if necessary to 40mg twelve hourly. Q Not recommended. D Cardiogenic shock. unstable angina pectoris, advanced aortic stenosis, porphyria, acute MI. Women of child-bearing potential. Pregnancy, lactation. B Caution: Severe hypotension, poor cardiac reserve, diabetes, malignant hypertension, irreversible renal failure with hypovolaemia, risk of hypotensive crisis (medical supervision). 20mg Retard tab. contain lactose. C Not recommended: Rifampicin, antiepileptics. Caution: Cimetidine, erythromycin, nefazodone, azole antifungals, digoxin, diltiazem, cyclosporine, tacrolimus, vincristine, antidiabetics, qinidine, cisapride. Avoid grapefruit juice. A Headache, facial reddening, palpitations, dizziness, leg oedema.
sympathomimetics, prostaglandin synthetaseinhibiting drugs, anaesthetics, cimetidine. A Oedema, dizziness, headache, GI disturbance, purpura, impotence, fatigue.
ventricular (LV) failure until appropriate IV therapy. P Hold canister to mouth, spray under tongue and close mouth immediately. Acute attack: 1-2 doses; max. 3 per attack. ExerciseNITRO-DUR Schering-Plough induced angina: 1-2 doses before exertion. LV failure: 2 doses as quickly as possible in upright 2MO position, repeated as necessary. Nitrate. Glyceryl trinitrate 0.1mg/hour (20mg), Q Not recommended. 0.2mg/hour (40mg), 0.4mg/hour (80mg), 0.6mg/ hour (120mg). Transdermal patch. 0.1mg/hour-28, D Hypotensive shock, severe anaemia, cerebral haemorrhage and brain trauma, mitral A14.05; 0.2mg/hour-28, A18.36; 0.4mg/hour-28, stenosis, arterial hypoxaemia, uncorrected A20.32; 0.6mg/hour-28, A22.36. hypovolaemia and angina caused by hypertrophic S Prophylaxis of angina pectoris. obstructive cardiomyopathy. Pregnancy, lactation P Initially one 0.2mg/hour patch daily; (unless benefi outweighs risk). titration to higher or lower doses may be C Contra: Phosphodiesterase inhibitors for necessary. Patches are suitable for continuous or intermittent use. Patches may be applied for a 12 erectile dysfunction. A Headache, somnolence, dizziness, hour period then removed to provide a nitratetachycardia, hypotension, orthostatic hypotension. free interval, of 12 hours. Q Not recommended. NORTENOLOL Tillomed D Severe hypotension, increased 3MO intracranial pressure, myocardial insufficiency. B Acute myocardial infarction, CHF. Cardio-selective b-blocker. Atenolol 25mg, 50mg, Arterial hypoxemia due to anaemia. Closed angle 100mg. White, white, orange unscored film-ctd glaucoma. tabs. marked A25, A50, A100 resp. 25mg-30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. C Vasodilating agents, ACE inhibitors, alcohol, anti-hypertensive agents, b-blockers, S Angina pectoris. phenothiazines, Ca++ channel blocking agents. P 100mg daily or 50mg twice daily. Renal A Headache, dizziness, rash. impairment: See SPC. Q Not recommended. NITROCINE UCB D See 2.4, b-blockers Drug Presc. Notes.
2N
Nitrate. Glyceryl trinitrate 1mg/ml. Soln. in amps. and bottles. Amps.-10 x 10ml, A128.94; Bottles-1 x 50ml, A30.22. S Rapid control of hypertension and myocardial ischaemia during cardiac surgery. Reduction of BP and controls for hypotension NIFTEN AstraZeneca during surgical procedures. Treatment of unresponsive CHF secondary to acute MI. Indicated 3MO for unstable angina. Cardioselective b-blocker/Class II Ca++ antagonist. P Surgery: Starting dose 25mcg/min Atenolol 50mg, sust.-release nifedipine 20mg. increased by increments of 25mcg/min at 5 min Reddish brown cap. marked NIF-TEN. 28, A12.96. intervals until BP stabilised. 10 -200mcg/min S Angina inadequately controlled on sufficient; max. 400mcg/min. Perioperative monotherapy. myocardial ischaemia: 15 – 20mcg/min with P 1 twice daily, if necessary prophylactic increments of 10 -15mcg/min until stabilised. nitrate therapy or additional nifedipine may be Unresponsive CHF: 20 -25mcg/min increased in given. steps of 20 -25mcg/min every 15 – 30mins R Max. 1 twice daily. until stabilised. Lowest dose: 10mcg/min. Unstable Q Not recommended. angina: Initial dose 10mcg/min with increments of D Bradycardia, cardiogenic shock, hypotension, metabolic acidosis, severe peripheral 10mcg/min every 30 mins. arterial circulatory disturbances, 2nd or 3rd degree D Anaemia, severe cerebral haemorrhage, head trauma, uncorrected hypovolaemia, severe heart block, sick sinus syndrome, untreated phaeochromocytoma, uncontrolled HF, pregnancy, hypotension. Pregnancy, lactation. B Monitor pulse and BP. Hypothyroidism, lactation, severe aortic stenosis, marked renal severe liver/renal disease, hypothermia, impairment (ccQ 15 ml/min). malnutrition. B Controlled HF. Conduction defects or C b blockers, Ca++ antagonists, alcohol. poor cardiac reserve. Prinzmetal’s angina, 1st PDE-5 inhibitors e.g. Sildenafil. Do not admin. degree heart block. May aggravate less severe within 48 hours after taking PDE-5 inhibitors. peripheral arterial circulatory disturbances. May Neuroleptics, TCAs. modify tachycardia of hypoglycaemia. May mask A Headaches, nausea, hypotension, thyrotoxicosis. Will reduce heart rate. Do not tachycardia, retching, sweating, apprehension, discontinue abruptly in ischaemic heart disease. restlessness, muscle twitching, retrosternal History of anaphylactic reaction to allergens. discomfort, palpitations, dizziness, abdominal pain. Asthmatics, diabetes, clinically significant liver disease. Discontinue if ischaemic pain occurs. Use NITROLINGUAL SPRAY Merck Serono in men in in vitro fertilisation. 2MO C Contra: Ca++ channel blockers with Nitrate. Glyceryl trinitrate 0.4mg per metered negative inotropic effects (e.g. verapamil, dose. Pump spray. 200 dose, A5.07. diltiazem), rifampicin. Grapefruit juice, not recommended. Caution: Other dihydropyridines, S Treatment and prophylaxis of angina, digitalis glycosides, clonidine, class 1 incl. variant angina. Emergency treatment of antiarrhythmics (e.g. disopyramide), amiodarone, pulmonary oedema secondary to acute left
PROCORALAN
Servier
2NO Pure heart rate lowering agent. Ivabradine 5mg, 7.5mg (as ivabradine HCl). Salmon, film-ctd tabs. marked with strength on one side and symbol on reverse. 5mg oblong scored; 7.5mg triangular. 5mg-56, A56.00; 7.5mg-56, A56.00. S Chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm: In patients unable to tolerate or with a contra-indication to b-blockers; in combination with b-blockers in patients inadequately controlled with optimal b-blocker dose and with heart rate q 60bpm. P Initially, 5mg twice daily (morning and evening during meals). After three to four weeks, may be increased to 7.5mg twice daily. If heart rate decreases persistently Q 50bpm at rest or if symptoms of bradycardia occur, titrate dose downward possibly to 2.5mg twice daily. Discontinue if heart rate Q 50bpm or symptoms of bradycardia persist. R 75 years or more, consider initial dose of 2.5mg twice daily. Q Children and adolescents, not recommended. D Resting heart rate Q 60bpm before treatment, cardiogenic shock, acute MI, severe hypotension (Q 90/50mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, HF NYHA III-IV, pacemaker dependent, unstable angina, AV-block 3rd degree. Pregnancy, lactation. B Avoid: AV-block 2nd degree, atrial fibrillation or other cardiac arrhythmias interfering with sinus node function, immediately after a stroke, congenital QT syndrome. Caution: Severe renal insufficiency (ccQ15ml/min), moderate hepatic impairment, HF NYHA I-II, asymptomatic LV dysfunction, retinitis pigmentosa, mild to moderate hypotension. Monitor for occurrence of atrial fibrillation. Contains lactose. C Contra: Strong CYP3A4 inhibitors (azole
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
37
2.2 ANGINA
CIRCULATORY SYSTEM
10-30ml/min: Quarter normal dose; cc Q10ml/min: Avoid. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Prolonged QT interval, torsades de pointes, renal SELECTOL sanofi-aventis failure. B Caution: Pre-existing arrhythmias, QT 3MO interval q 550msec. Electrolyte disturbances esp. Vasodilating cardioselective b-blocker. Celiprolol hypokalaemia or hypomagnesaemia. Caution: Left (HCl) 200mg, 400mg. 200mg yellow heart-shaped tab.; 400mg white heart-shaped tab. Both marked ventricular dysfunction, recent MI. See b-blockers Prescribing Notes. See 2.4, b-blockers Drug Presc. with logo one side and 200 or 400 on reverse. RANEXA A. Menarini 200mg-28 (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), Notes. ;NO A15.11. SUSCARD BUCCAL Forest S Angina pectoris. Antianginal. Ranolazine 375mg, 500mg, 750mg. P 200mg once daily. In case of inadequate 2 M O Resp. pale blue, light orange or pale green ovalshaped prolonged-release tabs engraved with CVT response, increase to 400mg once daily taken one Nitrate. Glyceryl trinitrate 2mg, 3mg, 5mg. White hour before or two hours after meals. and strength on one side. 375mg-60, A53.37; sust.-release tabs. marked with tab. strength. 2mgQ Not recommended. 100, A20.19; 3mg-100, A28.29; 5mg-100, A39.67. 500mg-60, A53.37; 750mg-60, A53.37. D See 2.4, b-blockers Drug Presc. Notes.. S Add-on therapy for symptomatic S Treatment and prophylaxis of angina Acute HF or during episodes of HF treatment of patients with stable angina pectoris pectoris. decompensation requiring IV inotropic therapy. inadequately controlled or intolerant to first-line P Acute: initially 2mg as required. Chronic: antianginal therapies (b-blockers and/or Ca++ 2mg three times daily increasing strength and SOPROL Helsinn Birex frequency if necessary. Place tab. high up between antagonists). the upper lip and gum and allow to dissolve. P Initially 375mg twice daily. After 2-4 3MO Q Not recommended. weeks, titrate to 500mg twice daily. May be Cardioselective b-blocker. Bisoprolol fumarate A Headache, flushes. further titrated to 750mg max twice daily. Down- 5mg, 10mg. White film-ctd tabs. marked titration to 500mg or 375mg twice daily may be BISOPROLOL and tab. strength on one side. 5mgTENORMIN AstraZeneca required if adverse events occur. Moderate hepatic 28, A3.45;10mg-28, A3.86. impairment, mild to moderate renal impairment, 3MO S Angina pectoris. CHF, low weight, elderly: Caution during titration. P Usually 10mg once daily; max. 20mg Cardioselective b-blocker. Atenolol 25mg, 50mg, daily. 100mg. White, white, orange biconvex film-ctd Q Not recommended. Q Not recommended. tabs. marked Tenormin 25, Tenormin 50, and D Severe renal impairment (ccQ30 ml/ D See 2.4, b-blockers Drug Presc. Notes. Tenormin respectively. 100mg bisected on reverse. min). Moderate/severe hepatic impairment. Acute HF or during episodes of HF 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, Pregnancy (unless clearly necessary), lactation. A3.23. decompensation requiring IV inotropic therapy. B Caution when prescribing or uptitrating: C See 2.4, b-blockers Drug Presc. Notes. S Cardiac arrhythmias. Early intervention Patients at increased exposure risk (mild hepatic Avoid: Floctafenine, sultopride. Caution: in acute MI. Angina pectoris. Hypertension. impairment, mild to moderate renal impairment Rifampicin, baclofen, iodated contrast products, P 50-100mg daily. (cc, 30-80ml/min), elderly, low weight (R60 kg), mefloquine, corticosteroids. Q Not recommended. moderate to severe CHF (NYHA Class III窶的V)), if D See 2.4, b-blockers Drug Presc. Notes. SORMON Gerard several factors are combined monitor adverse TILDIEM LA Sanofi events frequently, reduce dose, discontinue 2MO treatment if needed; increased exposure risk in 2MO Nitrate. Isosorbide mononitrate 60mg. Yellow, patients lacking CYP2D6 activity; congenital or ++ elliptical, film-ctd tab. with breaklines, marked IM Class III Ca antagonist. Diltiazem (HCl) 200mg family history of long QT syndrome, known 60 on one side. 28, A10.24. pink/grey cap.; 300mg white/yellow cap.; acquired QT interval prolongation. Check renal containing immediate release and sust.-release S Prophylaxis of angina. function regularly. Contains lactose, E110, E102. pellets. 200mg-28, A11.87; 300mg-28, A12.95. P 1 daily in the morning, increasing if C Contra: Potent CYP3A4 inhibitors, Class necessary to max. 2 once daily. S Angina. Ia or Class III antiarrhythmics other than Q Not recommended. P Initially 1 x 300mg once daily, increasing amiodarone. Avoid Ranexa initiation: Inducers of D Acute myocardial infarction, anaemia, if necessary to 2 x 200mg once daily, or then 1 x CYP3A4. Careful titration (down titration may be head trauma, cerebral haemorrhage, severe 200mg plus 1 x 300mg daily. required): Moderately potent CYP3A4 inhibitors, P- hypotension, cerebrovascular insufficiency. R Initially 1 x 200mg daily increasing to 1 gp inhibitors. Caution: CYP2D6 inhibitors, CYP2B6 Pregnancy, lactation. x 300mg once daily. substrates, digoxin (monitor levels during initiation B Closed angle glaucoma. Hypothyroidism, Q Not recommended. and termination of Ranexa), drugs known to malnutrition, severe renal or hepatic disease. 2MO prolong the QTc interval such as certain C Alcohol. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, antihistamines, certain antiarrhythmics, A Headache, dizziness, nausea, 120mg. Off-white sust.-release tabs. 90mg-56, erythromycin and TCAs. hypotension, collapse. A13.66; 120mg-56, A15.19. A Dizziness, headache, GI disorders, P 90-120mg twice daily. Max. 480mg asthenia. SOTACOR BMS daily. Q Not recommended. 3MO RUSTIN Helsinn Birex Non-cardioselective b-blocker. Sotalol (HCl) 80mg, 2 M O 2MO ALSO TILDIEM Diltiazem (HCl) 60mg. Off-white 160mg. Both white tabs. scored on one side and tab. coded TILDIEM 60. 90, A15.48. Ca++ antagonist. Amlodipine 5mg, 10mg (as tab. strength marked on other side. 80mg-28, amlodipine besilate). White, round, slightly arched A1.60; 160mg-28, A3.16. P Usually 60mg three times daily, tabs. marked with AB 5 or AB 10 resp. 10mg tab. S Prevention of myocardial infarction. increasing if necessary to max. 480mg daily in is scored. 5mg-28, A4.40; 10mg-28, A6.58. Cardiac arrhythmias. Angina. Hypertension. divided doses. P Reinfarction: 320mg once daily, starting R Initially 60mg twice daily, increasing to S Prophylaxis of angina pectoris 5-14 days after infarction. Arrhythmias: Initial dose 90-120mg twice daily. associated with MI. 80mg either singly or as 2 divided doses. Allow 2-3 Q Not recommended. P 5mg once daily, may be increased to days between increments. Most respond to dose D Pregnancy. Sick sinus syndrome; 2nd or max. dose of 10mg daily depending on response. of 160-320mg admin. in 2 divided doses at 12 hr 3rd degree AV block; marked bradycardia. Q Not recommended. intervals. In renal impairment; cc q60ml/min: B Observe patients with mild bradycardia D Lactation, pregnancy (unless clearly Normal dose; cc 30-60ml/min: Half normal dose; cc or a prolonged PR interval. Measure heart rate necessary). antifungals, macrolide antibiotics, HIV protease inhibitors, nefazodone). Avoid: Ca++ channel blockers (verapamil, diltiazem), QT prolonging agents. Caution: Moderate CYP3A4 inhibitors, grapefruit juice, CYP3A4 inducers. A Transient luminous phenomena (phosphenes), blurred vision (discontinue if unexpected deterioration). Bradycardia, AV 1st degree block, ventricular extrasystoles. Headache, dizziness.
38
B Heart failure, hepatic impairment. A Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, oedema, fatigue.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
OEDEMA 2.3 affecting chorioretinal tissue and cochleovestibular structures. P 1 three times daily with meals. Q Not recommended. B Closed angle glaucoma. Pregnancy, lactation. UCB C MAOIs.
regularly in the elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Bradycardia, 1st degree AV block, ankle oedema, nausea, headache, rash.
TRANDATE 3MO
a/b-blocker. Labetalol (HCl) 100mg, 200mg. Orange film-ctd tabs. marked with tab. name and strength. 100mg-50, A5.07; 56, A5.67; 250; A24.16; 200mg-50, A8.18; 56, A9.16; 250, A38.27. S Hypertension, incl. hypertension of pregnancy and for long term management of hypertension following acute myocardial infarction. Angina. P Initially 100mg twice daily with food increasing if necessary at fouteen day intervals. Max. 2.4g daily in three or four divided doses. Q Not recommended. B See 2.4, b-blockers Drug Presc. Notes. Liver damage. Contains sodium benzoate.
TRANSIDERM-NITRO
Novartis
2MO Nitrate. Glyceryl trinitrate 5mg, 10mg or 15mg per 24 hours. Transdermal patches. 5mg-28, A17.46; 10mg-28, A19.17; 15mg-30, A19.94. S Prophylaxis of angina pectoris, as monotherapy or in combination with other antianginal agents. Apply to non-hairy area of lateral chest wall, remove and replace with new patch using a different site daily. P Commence with 5mg patch, increasing to 10mg or 15mg, max. 2 x 10mg if necessary. A nitrate free interval of 8-12 hours (usually at night) during each 24 hour period is recommended. Q Not recommended. D Severe hypotension or hypovolaemia. Raised intracranial pressure. Myocardial insufficiency due to obstruction. B Recent myocardial infarction or acute HF. Arterial hypoxemia due to anaemia. Closed angle glaucoma. A Headache, rash, dizziness.
TRANTALOL
Pinewood
3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White tabs. 25mg: Circular, flat, scored on one side. 50mg and 100mg: Biconvex, film-ctd, marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mg30, A3.90; 100mg-30, A5.50. S Angina pectoris. P 100mg once daily or 50mg twice daily. Renal failure: Reduce dose (see SPC). Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. B Caution: Patients with poor cardiac reserve. Will reduce heart rate. Contains lactose (50mg and 100mg). See 2.4, b-blockers Drug Presc. Notes. C See 2.4, b-blockers Drug Presc. Notes. A Precipitation of atrioventricular block, purpura, thrombocytopenia, impotence. See 2.4, bblockers Drug Presc. Notes.
VASTAREL
Servier
2MO Cellular anti-ischaemic. Trimetazidine (diHCl) 20mg. Red film-ctd tab. 90, A12.72. S All grades of angina and as an adjunct in the treatment of certain ischaemic disorders
P 40-120mg three times daily. Q Not recommended. D Cardiogenic shock. 2nd or 3rd degree AV block. Severe bradycardia. Uncompensated cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. VERAMIL Orion Bradycardia. C b-blockers, quinidine or digoxin. 2MO A Constipation, headache, flushes. Class I Ca++ antagonist. Verapamil chlor. 40mg, 80mg, 120mg. White film-ctd tabs. coded VL-40, 2.3 OEDEMA VL-80 and VL-120. 40mg-100, A5.17; 80mg-100, A8.67; 120mg-100, A11.56. ALDACTIDE Pharmacia S Chronic angina pectoris, both stable and 5NO unstable. Vasospastic (Prinzmetal variant) angina. + P 120mg three to four times daily. Angina K sparing/thiazide. Spironolactone, hydroflumethiazide 25mg/25mg, 50mg/50mg. of effort, 80mg three times daily may be Circular, biconvex, buff coloured, film-ctd tab. sufficient. Severe liver dysfunction: Use 1/3 dose. with peppermint odour marked SEARLE 101 and D Severe left ventricular dysfunction. Severe hypotension, cardiogenic shock. 2nd or 3rd SEARLE 180 resp. 25mg-100, A18.00; 50mg-28, A9.53; 100, A34.02. degree AV block. Marked bradycardia. Sick sinus syndrome. CHF incl. including uncompensated HF. S Hypertension, control of oedema in congestive heart failure. Lactation. P Hypertension, 25-100mg spironolactone B 1st degree AV block reported. Hypertrophic cardiomyopathy, elderly, attenuated daily with breakfast. CHF, initially 100mg neuromuscular transmission. Mild to moderate HF spironolactone daily with food; then adjust range 25-100mg daily. Continue at least 2 weeks for (control with digitalis and diuretics). Porphyria adequate response. (unsafe). Hepatic impairment (monitor during Q 1.5-3mg/kg spironolactone daily in long-term therapy). Contains lactose. Pregnancy. C Grapefruit juice, digitalis intoxication, IV divided doses. b-blockers (contra). Colchicine, cisapride (avoid). a/ D Anuria, acute renal insufficiency, severe or progessive renal failure, hyperkalaemia, b-blockers, CYP3A4 inhibitors/substrates, precoma associated with severe liver disease, antiarrhythmics, CCBs, cardiac glycosides, Addison’s disease, significant hypercalcemia. theophylline, imipramine, glyburide, doxorubicin, Neonates and young infants. Lactation. paclitaxel, tamoxifen, cimetidine, statins, B Monitor serum electrolystes periodically. almotriptan, halothane, dantrolene, Ca++ salts, May induce hyper/hypokalaemia, hyponatremia, alcohol, lithium, timolol eye drop, quinidine, hyperlipidaemia, hyperglycaemia, increases in antihypertensives. blood urea, hyperuricaemia; caution in elderly, A Constipation, headache, dizziness, obstruction of the urinary tract, hepatic or renal fatigue, rash, bradycardia, hypotension, cardiac impairment, diabetes, gout. Pregnancy. insufficiency, swelling of ankles. C Contra: K+suppl, K+ sparing diuretics. VERAP Rowex Caution: Diuretics, glucocorticoids, ACTH, digoxin, drugs with pro-arrhythmic effects, 2MO antihypertensives, aldosterone blockers, Class I Ca++ antagonist. Verapamil (HCl) 120mg, carbenoxolone, anaesthesia, colestyramine, 240mg. Beige scored and green oblong scored colestipol, lithium, skeletal muscle relaxants, both sides; both film-ctd prolonged release tabs. NSAIDs, aspirin, indometacin, mefenamic acid, 120mg-30, A5.43; 240mg-30, A10.85. antipyrine, ammonium chloride orcolestyramine. S Angina. A Gynaecomastia, GI upset, drowsiness, P 120-240mg twice daily. rash, photosensitivity, blood dyscrasias. Q Not recommended. D Cardiovascular shock, recent cardiac ALDACTONE Pharmacia infarction with complications, grade II and III AV 5NO block, sinu-atrial blockage, sick sinus syndrome. K+sparing. Spironolactone 25mg, 50mg, 100mg. B Monitor BP at regular intervals Round, biconvex tabs. with peppermint odour particularly in 1st degree AV block, hypotension, marked SEARLE/39, SEARLE/916 or SEARLE/134 bradycardia, atrial fibrillation/flutter or resp. 25mg, 100mg: Buff coloured. 50mg: White. simultaneous pre-excitation syndrome. Impaired 25mg-100, A10.56; 50mg-100, A21.10; 100mg-28, hepatic function. Pregnancy, lactation. A11.82; 100, A42.19. C Anti-arrhythmic drugs, b-blockers, S Oedema associated wit CHF, inhalation anaesthetics, quinidine, digoxin, hypertension, hepatic cirrhosis, malignant ascites, lithium, carbamazepine, cimetidine, ranitidine, nephrotic syndrome, primary aldosteronism. grapefruit juice. P CHF: 100mg daily increasing if necessary A Constipation, dizziness, giddiness, to 200mg daily; maintenance, 75-200mg daily. nervousness, headaches, fatigue, flush, paresthesia. Hypertension: 50-100mg daily increasing if necessary at two weekly intervals up to 200mg VERISOP Gerard daily. All with food. Other conditions, see SPC. 2MO Q Initially 3mg/kg daily in divided doses. ++ Class I Ca antagonist. Verapamil chlor. 40mg, D Anuria, acute renal insufficiency, 80g, 120mg. White tabs. marked VL and strength progressive/ severe renal impairment, one side, G on reverse. 40mg-100, A3.53; 80mghyperkalaemia, precoma associated with severe 100, A5.16; 120mg-100, A10.59. liver disease. Lactation. B Monitor serum electrolytes periodically. S Angina.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
39
2.3 OEDEMA
CIRCULATORY SYSTEM
maintenance, 2.5-5mg daily. D Severe electrolyte imbalance. Severe renal/hepatic impairment. Addison’s disease, established gout, ulcer or GI tract obstruction. B K+suppl. may be required (monitor electrolytes). Renal/hepatic impairment, obstruction of urinary tract, disorders altering electrolyte balance. May: Cause hyperuricaemia and aggravate gout; activate SLE. Diabetes. Pregnancy, lactation. Contains lactose. C Contra: Lithium. Cardiac glycosides, hypotensive agents (adjust dose). TCAs, hypoglycaemic agents, NSAIDs, probenecid, cholestyramine, other drugs known to cause photosensitivity. A Headache, dizziness, fatigue, postural ARELIX sanofi-aventis hypotension, GI disorders. Electrolyte disturbances (long term use). 5MO Loop diuretic. Piretanide 6mg. Yellowish-white, LEO Pharma oblong scored tab. marked with logo on one side CENTYL K 5MO and ARE on reverse. 20-A4.32. S Fluid retention. Thiazide/K+suppl. Bendroflumethiazide 2.5mg, K+ P Initially, 6mg daily, adjusted to max. Cl 573mg (7.7mmol K+) in slow -release wax core. 30mg. Green, sugar-ctd, oval, modified release tab. 250, A15.11. R Initially, 3mg daily. Q Not recommended. S Oedema (cardiac, renal or hepatic D Severe electrolyte imbalance, origin). hypovolaemia, hypotension, hypokalaemia, preP Initially 1-4 every morning; coma associated with hepatic cirrhosis, advanced maintenance, 1-2 daily. renal failure, digitalis intoxication. Pregnancy, Q Not applicable. lactation. D Precoma associated with hepatic B Impaired micturition or prostatic cirrhosis, Addison’s disease. Severe renal hypertrophy. Severely impaired renal function impairment. Hyperkalaemia. (monitor serum electrolytes). B Diabetes, renal impairment, obstruction C Aminoglycoside, cephalosporin, of urinary tract; caution. Obstruction of small corticosteroids, carbenoxolone, laxatives, antibowel, ulceration (discontinue if occurs). hypertensive agents, cardiac glycosides, nonPregnancy, lactation (only if essential). depolarising muscle relaxants, drugs used in C K+sparing diuretics, lithium. Caution: treatment of gout, lithium, NSAIDs. Cardiac glycosides, antihypertensives. A Rash, photosensitivity, myopia BURINEX LEO Pharma aggravation, blood dyscrasias, gout, fatigue. Acute pancreatitis, hyperuricaemia, GI upset, oliguria, 5MO dizziness, headache, muscle pain, thirst, dry Loop diuretic. Bumetanide 1mg, 5mg. White mouth. Vasculitis. scored tabs. 1mg marked 133 and lion logo; 5mg marked with tab. strength. Scoreline only to DIAMOX Goldshield facilitate swallowing; not to divide into equal 5MO doses. 1mg-28, A1.98; 5mg-28, A9.03. Carbonic anhydrase inhibitor. Acetazolamide S Oedema associated with congestive 250mg. White scored tab. marked LEDERLE 4395. heart failure, hepatic ascites and renal disease, 112, A15.56. incl. the nephrotic syndrome. 5NO P Usually 0.5-2mg as a single or divided dose, adjust according to patients response. ALSO DIAMOX PARENTERAL Acetazolamide Na+ Q Not recommended. 500mg. Powder in vial. 1, A20.40. D Precomatose states associated with liver S Congestive heart failure, drug-induced cirrhosis. Electrolyte depletion, anuria. oedema, pre-menstrual tension. B K+suppl. may be required. Renal or P Initially 250-375mg once daily in the hepatic impairment. Diabetes. Pregnancy, morning or on alternate days. Pre-menstrual lactation. Prostatic hypertrophy or impaired oedema, 125-375mg as a single daily dose micturition. Elderly. Use with nephrotoxic drugs. beginning 5-10days before menstruation. See SPC. C Lithium, digitalis, antihypertensives, Q Not recommended. aminoglycosides, cephaloridine. D Chronic closed angle glaucoma. Renal A Hypokalaemia, GI discomfort, rash, hyperchloraemic acidosis. Adrenal insufficiency. cramps, thrombocytopenia, gynaecomastia, Na+ or K+ depletion. ototoxicity, gout, leucopenia, hyperuricaemia, B Gout. Diabetes. Pregnancy. K+suppl. may hyperglycaemia, bone marrow depression, nausea, be required. Monitor fluid, electrolytes and blood. vomiting, dizziness, muscle tenderness. C Folic acid antagonists, hypoglycaemics, oral anticoagulants. CENTYL LEO Pharma A Flushing, thirst, headache, drowsiness, polyuria, paraesthesia, blood dyscrasias, 5MO Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, excitement, rash. circular, flat, slightly bevelled tabs. 2.5mg-500, DYAZIDE Goldshield A21.25; 5mg-100, A6.38; 500, A31.88. S Oedema (cardiac, renal, hepatic origin). 5 M O K+sparing/thiazide. Triamterene 50mg, HCTZ 25mg. P Initially 2.5-10mg every morning; May induce hyperkalaemia, hyponatremia, increases in blood urea; caution in elderly, obstruction of the urinary tract, hepatic or renal impairment. Pregnancy. C Contra: K+suppl., K+sparing diuretics. Avoid carbenoxolone, lithium. Caution: antihypertensives, diuretics, digitalis, cardiac glycosides, NSAIDs, anaesthesia, ammonium chloride, colestyramine, digoxin, aspirin, indometacin, mefenamic acid, antipyrine. A GI upset, drowsiness, headache, confusion, leg cramps, skin disorders, alopecia. Gynaecomastia, menstrual irregularities, breast pain, impotence, change in libido. Malaise, drug fever, lethargy.
40
Peach scored tab. coded E93. 30, A2.86. S Mild to moderate hypertension. Oedema. P Hypertension: initially 1daily. If added to already established therapy with another antihypertensive drug, the dosage should be reduced and later adjusted if necessary. Oedema: starting and maintenance dose 1 daily. R As for adults Q Not recommended. D Hyperkalaemia. Severe or progressive renal failure. Terminal hepatic cirrhosis, Addison’s disease. B Hepatic or renal impairment. Urinary tract obstruction. Diabetes; acidosis. Gout. Concomitant cardiac glycosides. Pregnancy, lactation. C K+suppl. K+sparing diuretics, lithium, digitalis, antihypertensives, indomethacin, ACE inhibitors. A Nausea, diarrhoea, cramps, weakness, headache, dry mouth, rash, blood dyscrasias.
FRUCO
Teva
5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) 5mg. Orange scored tab. marked FRU CO. 28, A2.78; 56, A5.43. S Congestive cardiac failure, nephrotic syndrome, corticosteroid therapy, oestrogen therapy. Ascites in association with cirrhosis. P 1-2 in the morning. Q Not recommended. D Precomatose states associated with liver cirrhosis. Progressive renal failure. Hyperkalaemia. B Hepatic or renal impairment. Elderly. Diabetes, acidosis. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. C K+suppl., K+sparing diuretics, lithium, digitalis, aminoglycosides, cephalosporins, antihypertensives, NSAIDs, ACE inhibitors, nonpolarising muscle relaxants, hypoglycaemics. A Malaise, GI upset, rash, blood dyscrasias.
FRUMIL
sanofi-aventis
5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) 5mg. Orange scored tab. marked FRUMIL. 28, A1.85; 56, A3.62. S Oedema associated with cardiac failure, hepatic and renal disease. P 1-2 in the morning. R Use Frumil LS. Q Not recommended.
5MO ALSO FRUMIL LS Furosemide 20mg, amiloride (HCl) 2.5mg. Orange tab. marked LS. 28 (Cal/Pk), A3.88. P 1 in the morning. Q Not recommended. D Precomatose states associated with liver cirrhosis. Progressive renal failure. Hyperkalaemia. B Hepatic or renal impairment. Diabetes, acidosis. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. C K+suppl., K+sparing diuretics, lithium, digitalis, aminoglycosides, cephalosporins, antihypertensives, NSAIDs, ACE inhibitors. A Malaise, GI upset, rash, blood dyscrasias.
FRUSIDE
Pinewood
5MO Loop diuretic. Furosemide 40mg. White, flat, bevel-edged tabs., engraved 2B2 with double
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM breakline on reverse. 100, A3.12; 500, A11.50. S Fluid retention, oedema of cardiac, hepatic or renal origin, pulmonary oedema and mild or moderate hypertension. P Initially 40mg daily, adjust as required from 20mg on alternate days to 120mg daily. R Titrate dosage as required (slower elimination). Q 1-3 mg/kg body weight daily. D Hypokalaemia or other electrolyte deficiency, anuria, pre-coma associated with liver cirrhosis, digitalis intoxication. Hypersensitivity to sulphonamides. B Monitor fluid and electrolyte state to avoid inadequate K+ suppl., or excessive loss of fluid. Bone marrow depression (monitor haemopoietic status). Diabetes mellitus (may induce hyperglycaemia). Elderly, potential obstruction of the urinary tract, disorders rendering electrolyte balance precarious. Lactation (not recommended), pregnancy. C Cardiac glycosides, hypotensive agents, non-depolarising muscle relaxants, lithium (adjust dosage). Effects of antidiabetics, pressor amines, salicylates, theophylline may also be affected. Cephaloridine or aminoglycosides (risk of aggravated toxicity). NSAIDs may attenuate furosemide action. Reduce or stop furosemide before treatment with ACE inhibitors. Glucocorticoids, laxatives (risk of increased K+ loss). A Fluid and/or electrolyte imbalance, hypotension, reduced serum Ca++ levels, transient increase of serum cholesterol and triglyceride levels, hyperuricaemia, aggravation of pre-existing metabolic alkalosis. Nausea, gastric upset, malaise, rashes, photosensitivity, diarrhoea, headache, muscle cramps, tinnitus, gout, ototoxicity.
HYPERTENSION 2.4 cardiac glycosides, digitalis preparations, drugs inducing QT interval prolongation syndrome, phenytoin, metolazone, probenecid, methotrexate, antidiabetic drugs, BP increasing sympathomimetics, curare type muscle relaxants, theophylline, risperidone. A Increase in cholesterol. Thromboses, vasculitis. GI upset. Hearing disorders, tinnitus. Skin disorders. Severe anaphylactic /anaphylactoid reactions. Paraesthesiae. Blood and lymphatic system disorders. Inj. site reactions, fever.
resp., brown film-ctd tabs. All marked with tab. strength. 40mg: Reddish-brown, oval biconvex film-ctd tab. with debossing 40 on one side and PD 535 on reverse. 5mg-28, A8.38; 10mg-28, A9.57; 20mg-28, A9.81; 40mg-28, A10.05. S All grades of essential hypertension as monotherapy or in combination with diuretics. P Initially 10mg once daily adjusting according to response; usual maintenance, 2040mg daily as single or in two divided doses; max. 80mg daily. Initial dose with concurrent diuretics, 5mg once daily. METOPIRONE Novartis R Initially 5mg once daily. Q 6-12 years, not recommended. 2MO Aldosterone inhibitor. Metyrapone 250mg. Cream D Subaortic stenosis, history of ACE inh. related angioneurotic oedema. Pregnancy, cap. coded CIBA and LN. 50, A14.42. lactation. S With glucocorticoids to treat resistant B Hypoglycaemia, neutropenia/ oedema due to increased aldosterone secretion. agranulocytosis, anaphylactoid reactions. Caution: Diagnosis and management of Cushing’s Hepatic impairment, alcoholic cyrrhosis. Renal syndrome; see SPC. insufficiency; monitor renal function before and P Resistant oedema, 3g daily in divided during therapy. Contains lactose. doses. Cushing’s syndrome, see SPC. C Avoid tetracyclines. Caution: b-blockers, Q 15mg/kg every 4 hours; min. 250mg methyldopa, diuretics, lithium, agents increasing every 4 hours. serum K+, antidiabetics, surgery/anaesthesia. D Primary adrenocortical insufficiency. A Pharyngitis, insomnia, hyperkalaemia, Pregnancy, lactation. paraesthesia, dyspnoea, abdominal pains, back B Hypopituitarism. A Nausea, vomiting, hypotension, allergic pain, myalgia, asthenia. reactions, abdominal pain, sedation, dizziness, ACCURETIC Parke-Davis headache, hypoadrenalism, hirsutism.
MODURET 25
5MO MSD ACE inhibitor/thiazide diuretic. Quinapril 20mg,
HCTZ 12.5mg. Pink, triangular, biconvex, film-ctd tab. with a scoreline on 1 side, plain on reverse. 28 (Cal/Pk), A12.56. S Hypertension. P Initially 10/12.5mg, increasing to 20/ 12.5mg as necessary. R As low as possible. Q Not recommended. D Hereditary/idiopathic angioneurotic oedema, history of angioneurotic oedema relating to previous treatment with an ACE inhibitor, anuria, hyperkalaemia, subaortic stenosis, left ventricular outflow tract obstruction, renal insufficiency, hypersensitivity to quinapril, thiazides or any sulphonamide-derived drug. Pregnancy, lactation. B Renal or liver impairment, severe CHF, NATRILIX SR Servier renal artery stenosis, haemodialysis, diabetes, anaesthesia, hypotension, anaphylactoid reactions, 5MO hypoglycaemia and diabetes. History of allergy or Antihypertensive diuretic. Indapamide bronchial asthma. Monitor renal function. hemihydrate 1.5mg. White sust.-release coated C Tetracyclines, K+ sparing diuretics, K+ tab. 30, A3.25. suppl., lithium, corticosteroids, NSAIDs, S Hypertension. tubocurarine, ACTH, NA. P 1 daily. A Headache, dizziness, rhinitis, coughing, Q Not recommended. fatigue, myalgia, GI upset, chest pain, insomnia, D Severe renal failure, hepatic chest infections. Sensitivity reactions, angioedema. encephalopathy or severe hepatic failure, hypokalaemia. ACEOMEL Clonmel B Pregnancy, lactation. Monitor K+ and 2MO uric acid serum levels. Monitor blood glucose in diabetics. ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. C Lithium, agents causing hypokalaemia, White scored tabs. marked with logo one side and baclofen. coded 344, 345 or 346 on reverse. 12.5mg-56, A Hypokalaemia, fatigue, orthostatic A7.73; 25mg-56, A8.69; 50mg-56, A14.80. hypotension, allergic manifestations. S Hypertension. P Initially 25mg daily and titrate according 2.4 HYPERTENSION to response at 2-4 week intervals. Usual max. 100mg in single or divided doses. Add a diuretic if ACCUPRO Pfizer required. Elderly and those patients already on 2MO diuretic therapy, initially 25mg once daily and ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. titrate according to response. Renal impairment, 5mg, 10mg, 20mg: Elliptical, triangular or round initiate at a lower dose, 12.5mg daily and titrate
5MO
K+sparing/thiazide diuretic. Amiloride (HCl) 2.5mg, HCTZ 25mg. Off-white diamond-shaped scored tab. coded 923. 28, A2.17. S Hypertension. LASIX sanofi-aventis P 1 tab. once daily. In some cases a starting dose of half a tab. once daily. 5MO Q Not recommended. Loop diuretic. Furosemide 20mg, 40mg. White D Hyperkalaemia. Progressive or severe round tab. marked DL or DLI resp. on one side renal failure. Pregnancy, lactation. and Hoechst on the other. 20mg-60, A0.82; 40mg- B Diabetes, acidosis, gout, renal or hepatic 100, A1.99. impairment. S Fluid retention. Mild to moderate C K+suppl., K+sparing diuretics, digitalis, hypertension. lithium, antihypertensives. ACE inhibitors. P 20-80mg as single dose daily or on A Rash. photosensitivity, blood dyscrasias, alternate days. gout. Q 1-3mg/kg daily.
5N ALSO LASIX INJECTION Furosemide 20mg/2ml. 5, A1.49. P Initially 20-50mg as single dose IM or slow IV. See SPC. Q 0.5-1.5mg/kg daily. D Precomatose and comatose states associated with hepatic encephalopathy. Hypovolaemia, dehydration, anuria, renal failure, severe hypokalaemia, severe hyponatraemia. Pregnancy, lactation. B Hepatorenal syndrome. Hypotension. Premature infants (increased risk of persistence of patent ductus arteriosus). Hypoproteinaemia. Acute porphyria. Glucose intolerance. Gout. Diabetes. Prostatic hypertrophy or impaired micurition. Monitor electrolytes and creatinine. Tabs. contain lactose. C Lithium, cyclosporin, radio-contrast therapy, aminoglycosides, nephrotoxic antibiotics, cephalosporins, sucralfate, corticosteroids, corticotrophin, amphotericin B, ACE-inhibitors, chloral hydrate, antihypertensives, diuretics, other hypotensive agents, NSAIDs, carbamazepine, aminoglutethimide, carbenoxolone, liquorice, B2 sympathomimetics, laxatives, reboxetine, cisplatin,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
41
2.4 HYPERTENSION
CIRCULATORY SYSTEM
Drug Prescribing Notes BETA-BLOCKERS Non-selective ȕ1 /ȕ2 antagonists: Pindolol, propranolol, sotalol, tertatolol, timolol Cardioselective ȕ1 antagonists: Atenolol, betaxolol, bisoprolol, celiprolol, esmolol, metoprolol, nebivolol Non selective with Į1-blocking activity: Carvedilol, labetalol Contraindications N Hypersensitivity to other ȕ-adrenergic receptor blocking agents N Bradycardia (heart rate at rest < 60 beats/minute before therapy) N Cardiogenic shock N Hypotension (systolic blood pressure < 90 mmHg) N Metabolic acidosis N Advanced stages of peripheral arterial occlusive disease N Second and third degree heart block (without a pacemaker) N Sick sinus syndrome, including sino-atrial block N Overt heart failure (uncontrolled) N Untreated phaeochromocytoma N Bronchial hyper-reactivity (e.g. bronchial asthma, history of bronchospasm) Special Precautions N First-degree heart block, because of the negative effect of ȕ-blockers on conduction time N Peripheral circulatory disorders (Raynaud's syndrome, intermittent claudication); possible aggravation N Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction; ȕ-blockers may increase the number and duration of anginal attacks (contraindicated with non-selective ȕ-blockers) N Diabetics with highly unstable blood glucose concentrations (risk of severe hypoglycaemic episodes) N Prolonged fasting or great physical exertion (risk of severe hypoglycaemic episodes) N Impaired hepatic or renal function N History or family history of psoriasis N History of severe hypersensitivity reactions, hyposensitisation therapy (ȕ- blockers may increase susceptibility to allergens and risk of exaggerated anaphylactic reactions) N May mask the signs of hyperthyroidism N COPD (ȕ-blockers may aggravate airway constriction) N Discontinue gradually, i.e. over 1-2 weeks Pregnancy: ȕ-blockers reduce placental perfusion, which may result in intra-uterine foetal death, intra-uterine growth retardation, immature and premature deliveries. Additional adverse effects include hypoglycaemia in the neonate and bradycardia in the foetus and in the neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. As with all drugs, ȕ-blockers should not be given during pregnancy unless its use is essential. Lactation: Most ȕ-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breastfeeding is not recommended following their administration. Drug Interactions Not recommended: Clonidine (rebound hypertension can follow withdrawal of clonidine). Ca++ channel blockers with negative inotropic effects (e.g. verapamil, diltiazem) can lead to an exaggeration of these effects which may result in severe hypotension, bradycardia and cardiac failure (admin. IV at least 48 min apart). Class I antiarrhythmics such as disopyramide, quinidine, procainamide (may have potentiating effect on atrial-conduction time and induce negative inotropic effect), lignocaine (increased lignocaine level). Neurone blocking agents such as guanethidine, reserpine, TCAs, barbiturates, MAOIs (except MAO-B inhibitors), phenothiazines, or other centrally acting antihypertensives (additive effect on antihypertensive action). Caution: Hypoglycaemic therapy in diabetic patients (may prolong the hypoglycaemic response to insulin; prevent the appearance of signs of hypoglycaemia). Anaesthetics (avoid myocardial depressants, such as cyclopropane, trichloroethylene, chloroform, ether or related anaesthetic). Dihydropyridine Ca++ channel blockers e.g. amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine (concomitant use may increase the risk of hypotension). Digitalis glycosides (may increase atrioventricular conduction time). Sympathomimetics e.g. adrenaline (may counteract the effect of ȕ-blockers). Ergotamine, dihydroergotamine or related compounds (vasospastic reactions reported). Prostaglandin synthetase inhibiting drugs e.g. ibuprofen and indomethacin (may decrease the hypotensive effects). Cimetidine, hydralazine, alcohol (may increase plasma levels of hepatically metabolised ȕ-blockers). Chlorpromazine (increase in plasma levels of both drugs). Class-III antiarrhythmics e.g. amiodarone (Class III agents, as well as Class I, and other drugs prolonging the QT-interval should not be given together with sotalol). Side-Effects Bradycardia, HFdeterioration, hypotension, peripheral vasoconstriction (e.g. Raynaud's phenomenon, exacerbation of intermittent claudication). Dizziness, confusion, mood changes, psychoses, hallucinations, sleep disturbances, nightmares. Hypoglycaemia, GI disorders, fatigue, rashes, exacerbation of psoriasis, alopecia, visual disturbances, dry eyes, bronchospasm, paraesthesia, exacerbation of myasthenia gravis.
42
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HYPERTENSION 2.4
according to response. Q Contact manufacturer. D Aortic stenosis. See SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, monitor white cell count and urinary protein. Anaesthesia. C K+sparing diuretics, K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, probenecid, immunosuppressants, lithium. A Rash, loss of taste, neutropenia, thrombocytopenia, proteinuria, hypotension, angioedema. Anaemia, elevated blood urea and creatinine, elevated serum potassium and acidosis, tachycardia, pruritis, flushing, vesicular or bullous rash and photosensitivity, elevation of liver enzymes has been noted in a few patients, rare cases of hepatocellular injury and cholestatic jaundice. Gastric irritation and abdominal pain may occur, paraesthesias of the hands, serum sickness, cough, bronchospasm and lymphadenopathy.
ACERYCAL
anaesthetics. Diuretics, sympathomimetics, gold, bblockers, vasodilatators. A Somnolence, dizziness, headache, paresthaesia, vertigo, visual disturbances, tinnitus, palpitations, flushing, hypotension, GI disturbances, pruritus, rash, muscle cramps, oedema, peripheral oedema, fatigue, asthenia, dry cough.
C Contra: Rifampicin. Avoid grapefruit juice. Caution: Antihypertensive agents, cimetidine, quinidine, digoxin, phenytoin, diltiazem, cisapride, quinupristin/dalfopristin, CYP3A4 inhibitors. A Headache, vasodilatation, palpitation, nausea, dizziness, oedema. Lethargy, asthenia, constipation.
ADALAT LA
ADIZEM XL CAPSULES
Bayer Schering
2MO
Class II Ca antagonist. Nifedipine 20mg, 30mg, 60mg. Pink modified-release tab. marked ADALAT 20, ADALAT 30 and ADALAT 60. 20mg-28, A9.21; 30mg-28, A11.85; 60mg-28, A17.61. S Mild to moderate hypertension. P Initially 20mg once daily in the morning. Increase if necessary up to max. 90mg once daily. Tabs. must be swallowed whole with water. Q Not recommended.
Class III Ca antagonist. Diltiazem (HCl) 120mg pink/blue cap.; 180mg pink/blue cap.; 240mg red/ blue cap.; 300mg maroon/blue cap. All cont.release caps. marked with DCR and strength. 120mg-28, A8.40; 180mg-28, A12.45; 240mg-28 A16.05; 300mg-28, A12.42. S Mild to moderate hypertension. P Initially 240mg once daily adjusting according to response. Caps. should be swallowed whole. R Initially 120mg once daily; carefully titrate as required. Q Not recommended.
++
2MO
Servier ALSO ADALAT RETARD Nifedipine 10mg, 20mg.
2MO ACE inhibitor / Ca++ antagonist. Perindopril arginine / amlodipine, 5mg/5mg, 5mg/10mg, 10mg/5mg and 10mg/10mg. White tab. engraved with strength on 1 side and Servier logo on the other. 5/5mg, rod-shaped; 5/10mg, square-shaped; 10/5mg, triangular-shaped; 10/10mg, round. 5/ 5mg-30, A25.66; 5/10mg-30, A31.13; 10/5mg-30, A34.41; 10/10mg-30, A39.88. S Substitution therapy for treatment of essential hypertension and/or stable coronary artery disease, in patients already controlled with perindopril and amlodipine given concurrently at same dose level. P 1 tab./day as single dose, preferably the morning before a meal. Not suitable for initial therapy. Q Not recommended. D Hypersensitivity to ACE inhibitors and dihydropyridines. History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Severe hypotension. Shock, including cardiogenic shock. Obstruction of the outflow-tract of the left ventricle (e.g. high grade aortic stenosis). Unstable angina pectoris (excluding Prinzmetal’s angina). HF after acute MI (during first 28 days). Pregnancy, lactation. B May rarely occur: Hypersensitivity, angioedema (discontinue if occurs) or anaphylactoid reactions during LDL-apheresis and desensitisation, neutropenia, agranulocytosis, thrombocytopenia, anaemia, hepatic failure, symptomatic hypotension (in patients with salt or volume depletion), hyperkaliemia. Caution: Aortic and mitral valve stenosis, hypertrophic cardiomyopathy, heart failure, collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, hepatic impairment. Renal impairment: Adjust dosage according to individual dose titration with the monocomponents. Discontinue 1 day prior to surgery. Closely monitor glycaemic control in diabetic patients. Contains lactose. C Not recommended: K+-sparing diuretics, K+ supplements, K+-containing salt substitutes, lithium, estramustine, dantrolene. Caution: NSAIDs, antidiabetics (insulin, hypoglycaemic sulphonamides), CYP3A4 inducers / inhibitors, baclofen, corticosteroids, tetracosactide, alphablockers, amifostine, TCAs, antipsychotics,
Mundipharma
2MO
Pink tab. marked A10 and 1U on one side resp. and Bayer cross on reverse. 10mg-56, A9.72; 20mg-56, A11.87. P Initially 10mg twelve hourly adjusting to response, increasing to 40mg every 12 hours. Q Not recommended.
++
2MO
ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg white cap.; 120mg brown/white cap.; 180mg brown/white cap. All cont. -release caps. marked with strength. 90mg-56, A12.80; 120mg-56, 2MO A14.21; 180mg-56, A21.32. ALSO ADALAT Nifedipine 5mg, 10mg. Orange, P Initially 90mg twice daily. Increase gelatin ovoid caps. containing yellow fluid. 5mggradually to 120mg or 180mg twice daily as 90, A3.03; 10mg-90, A3.85. required. P Initially 5mg eight hourly adjusted R Start at lowest level of 90mg twice according to response, increasing to max. 20mg daily; carefully titrate as required. every 8 hrs. Q Not recommended. Q Not recommended. D Pregnancy, lactation. Sick sinus D Women of child-bearing potential, syndrome, 2nd or 3rd degree AV block, marked lactation, cardiogenic shock, aortic stenosis. Acute bradycardia, decompensated cardiac failure. angina attacks, unstable angina pectoris, during or B Mild bradycardia, prolonged PR interval. within one month of MI. Adalat LA only: Hepatic Measure heart rate regularly in elderly and in impairment, history of GI obstruction, IBD, Crohn’s patients with hepatic or renal impairment. disease. Diabetes. B Poor cardiac reserve, HF, hepatic C b-blockers, digoxin, cimetidine, impairment, severe hypotension. Diabetes, dialysis. diazepam, antihypertensives, anaesthetics, Severe GI narrowing. Elderly. Driving/using dantrolene inf. machines. Postural hypertension, syncope, A Anorexia, nausea, bradycardia, oedema, tachycardia reported. rash, flushing, fatigue, AV block. Beta-blockers Unless otherwise specified, beta-blockers are prohibited in-competition only in the following sports: Aeronautic (FAI) Automobile (FIA) Billiards and Snooker (WCBS) Bobsleigh (FIBT) Boules (CMSB) Bridge (FMB) Curling (WCF) Golf (IGF) Gymnastics (FIG) Motorcycling (FIM) Modern Pentathlon (UIPM) for disciplines involving shooting Ninepin and Tenpin Bowling (FIQ) Powerboating (UIM) Sailing, (ISAF) match race helms only Skiing/Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snow board halfpipe/big air Wresting (FILA) Beta-blockers are prohibited in and out of competition in the following sports: Archery (FITA) Shooting (ISSF, IPC)
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
43
2.4 HYPERTENSION AMLID
CIRCULATORY SYSTEM Pinewood
AMLOTAN
Clonmel
2MO
2MO
Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round biconvex tab. 10mg tab. scored on both sides. 5mg-28, A9.19; 10mg-28, A13.70. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 12 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.
Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine mesilate monohydrate). White round biconvex tabs embossed with 5 or 10 resp. 10mg tab. scored. 5mg-28, A7.34; 10mg-28, A10.97. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.
AMLIST
AMOLIN
Gerard
Ergha
2MO
3MO
Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine maleate). White round tab. 10mg with break score on both sides. 5mg-28, A9.20; 10mg28, A13.75. S Essential hypertension. P 5mg once daily with water. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. Q Under 18 years, not recommended. D Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of outflow tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. Driving or using machines. C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, dizziness, asthenia, palpitations, flushing, nausea, dyspepsia, abdominal pain.
Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg. White film-ctd tabs. marked C23, C24 and C25 resp. 25mg-30, A1.56; 50mg-30, A2.36; 100mg-30, A3.10. S Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
Angiotensin II antagonist. Irbesartan 75mg, 150mg, 300mg. White oval tabs. marked with heart symbol and 2771, 2772 or 2773. 75mg-28, A16.49; 150mg-28, A18.33; 300mg-28, A24.74. S Essential hypertension. P Initially 150mg once daily. Usual maintenance dose 150mg once daily. Increase if necessary to 300mg once daily or add other hypertensive agents. Haemodialysis: Consider 75mg starting dose. R Over 75 years, consider starting dose of 75mg once daily. Q Not recommended. D Pregnancy. B Renovascular hypertension, renal impairment, hyperkalaemia, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism. If inadvertently taken during pregnancy, check skull and renal function with echography. Lactation not recommended (esp. newborn or preterm infants). Contains lactose. C K+sparing diuretics, K+suppl., lithium. A Headache, musculo-skeletal trauma, flushing.
ARELIX
sanofi-aventis
5MO
Loop diuretic. Piretanide 6mg. Yellowish-white, oblong scored tab. marked with logo on one side and ARE on reverse. 20-A4.32. S Mild to moderate hypertension. P Initially, 6mg daily for 2-4 weeks; may be increased if necessary at 2-4 week intervals to max. 18mg daily. R Initially, 3mg daily. APRESOLINE Novartis Q Not recommended. D Severe electrolyte imbalance, 2MO hypovolaemia, hypotension, hypokalaemia, preVasodilator. Hydralazine (HCl) 20mg. 2ml amp. 5, coma associated with hepatic cirrhosis, advanced A1.87. renal failure, digitalis intoxication. Pregnancy, S Hypertensive emergencies, including pre-eclampsia and toxaemia of pregnancy, and in lactation. B Impaired micturition or prostatic hypertension with renal complications. hypertrophy. Severely impaired renal function P Parenteral: Initially 5-10mg by slow IV inj; if necessary repeat inj. after 20-30min (monitor (monitor serum electrolytes). C Aminoglycoside, cephalosporin, BP and heart rate throughout). Satisfactory corticosteroids, carbenoxolone, laxatives, antiresponse defined as fall in diastolic BP to 90/ hypertensive agents, cardiac glycosides, non100mmHg. May also be given by continuous IV inf, beginning with 200-300mcg/min. Maintenance depolarising muscle relaxants, drugs used in treatment of gout, lithium, NSAIDs. AMLODE Rowex flow rates 50-150mcg/min. Q Not recommended. ATACAND AstraZeneca 2MO D Severe tachycardia and HF with high Ca++ antagonist. Amlodipine 5mg, 10mg (as 2MO cardiac output, myocardial insufficiency due to amlodipine besilate). White oblong, bevelled tab. mechanical obstruction, idiopathic SLE and related Angiotensin II antagonist. Candesartan cilexetil scored on one side and marked with strength on disease, dissecting aortic aneurysm, cor pulmonale. 2mg, 4mg, 8mg, 16mg. White, white, light pink other. 5mg-28, A8.33; 10mg-28, A12.50. and pink tabs. resp. 4mg, 8mg and 16mg scored. First half of pregnancy. S Essential hypertension. B Moderate to severe renal impairment or P 5mg once daily with water. If no hepatic dysfunction (adjust dose). Coronary or sufficient effect within 2-4 weeks, may be cerebrovascular disease. Lactation. Cardiac failure. increased to 10mg daily (as single dose). Reported: Peripheral neuritis; reduction in Hb, red Q Under 18 years, not recommended. cell counts (discontinue if occurs); SLE like D Hypersensitivity to dihydropyridine syndrome with prolonged treatment (determine This medicinal product derivatives. Severe hypotension, shock, HF after ANF and urine analyses approx. every 6 months). acute MI (during 1st 28 days), obstruction of contains substance(s) Driving/using machines. outflow-tract of left ventricle (e.g. high grade C Caution: TCAs, MAOIs, alcohol, major prohibited for use in specific aortic stenosis), unstable angina pectoris. tranquilisers, CNS depressants, anaesthetics, Pregnancy (unless essential), lactation. sports only (as listed in diuretics, antihypertensives, diazoxide, certain bB Hepatic impairment, cardiac failure, low WADA Prohibited List 2010). blockers (propranolol). cardiac reserve, elderly. A Tachycardia, hypotension, angina, Athletes requesting to use C Caution: CYP3A4 inhibitors/inducers. headache, flushes, arthralgia, myalgia, GI Other antihypertensives (e.g. a/b blockers, ACEthis product in these specific disturbances. inhibitors, diuretics). sports are required to apply A Ankle swelling, headache, facial APROVEL sanofi-aventis/BMS flushing, dizziness, fatigue, asthenia, palpitations, for a TUE. 2MO abdominal pain, nausea, dyspepsia.
Anti-Doping Information
s
44
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; 16mg-28, A24.74. S Hypertension. P Initially 8mg once daily. May be increased to 16mg once daily. Effect within 4 weeks. Max. 32mg once daily. Renal impairment/ vol. depletion: Initially 4mg daily. Mild/moderate hepatic impairment: Initially 2mg daily. Q Under 18 years, not recommended. D Severe hepatic impairment, cholestasis. Pregnancy, lactation. B Correct volume/salt depletion before starting therapy. Severe or end-stage renal impairment, renal artery stenosis, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. Primary hyperaldosteronism (not recommended). Monitor serum K+ in patients with HF or renal impairment. Contain lactose. C Caution: K+sparing diuretics, K+suppl., heparin, lithium, antihypertensives, indomethacin. A Dizziness/vertigo, headache, respiratory infection.
Cardioselective b-blocker/thiazide diuretic. Atenolol 50mg, chlorthalidone 12.5mg; atenolol 100mg, chlorthalidone 25mg. Both white tabs marked AC and strength one side, G on reverse. 50/ 12.5mg-28, A4.60; 100/ 25mg-28, A6.52. S Hypertension. P 1 tab daily. Q Not recommended. D 2o or 3o AV block, severe bradycardia, hypotension, uncontrolled HF, cardiogenic shock, hypokalaemia, hepatic/renal/addison’s disease. Severe peripheral arterial circulatory disturbances, metabolic acidosis, sick sinus syndrome, untreated phaeochromoctyoma. Pregnancy, lactation (only if essential). B Reduction in diastolic BP. Ischaemic heart disease: Withdraw gradually. Caution: CHF, asthma, obstructive airways disease. Poor cardiac reserve. Renal impairment, thyrotoxicosis/ hypoglycaemia, anaesthesia, hypokalaemia, pulse rate, serum uric acid, Prinzmetal’s angina, allergens, psoriasis. Driving/using machines. C Halogenated anaesthetics, class 1 antiATACAND PLUS AstraZeneca arrhythmics, NA or adrenaline. Adrenergic blockers, Ca++ channel blockers, hypoglycaemics, 5MO cardiac glycosides, non-depolarising muscle Angiotensin II antagonist/thiazide diuretic. relaxants. Clonidine, lithium, dihydropyridines, Candesartan cilexetil 16mg, HCTZ 12.5mg. Peach sympathomimetics, CYP450 inhibitors, alcohol, A scored tab. 28, 24.74. hydralazine. Prostaglandin synthetase inhibitors. S Essential hypertension where A Blood dyscrasias, electrolyte monotherapy is not sufficient. disturbances, hyperuricaemia, impaired glucose P 1 once daily. tolerance, hyponatraemia, confusion, mood Q Not recommended. changes, sleep disturbance, dizziness, headache, D Severe hepatic or renal impairment, paraesthesia, ocular changes, bronchospasm, GI refractory hypokalaemia and hypercalcaemia. disturbances, alopecia, rash, muscular fatigue, Gout. Pregnancy, lactation. impotence, fatigue. B Renal artery stenosis, intravascular volume depletion, renal impairment/kidney ATENI Gerard transplantation, hepatic impairment, aortic or mitral valve stenosis, primary hyperaldosteronism, 3 M O metabolic and endocrine effects. Cardioselective b-blocker. Atenolol 50mg, 100mg C K+sparing diuretics, K+suppl., lithium, white tabs. Both marked AT and strength one side, G on reverse. 50mg-28, A4.16; 100mg-28, NSAIDs, cholestyramine, anticholinergics, alcohol, A5.38. barbiturates, anaesthetics. A Headache, back pain, dizziness, S Hypertension. respiratory infection, influenza like symptoms, P 50mg once daily increasing to 100mg if sinusitis, bronchitis, UTI, nausea, tachycardia, required. fatigue, abdominal pain, pharyngitis. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
HYPERTENSION 2.4 100mg-30, A5.01. S Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
BELLISIN
Ranbaxy
2MO
ACE inhibitor. Lisinopril (as dihydrate) 10mg, 20mg. Uncoated tabs debossed with strength on 1 side. Light yellow biconvex cap-shaped tab. (10mg); light peach biconvex cap-shaped tab. (20mg). 10mg-28, A7.87; 20mg-28, A9.32. S Hypertension. Renal disease in hypertensive patients with Type 2 diabetes and incipient nephropathy. P Hypertension: Initially, 10mg. Highly activated reninangiotensin-aldosterone system: 2.5-5mg initially. Maintenance, 20mg (single dose); if desired therapeutic effect not obtained within 2 to 4 weeks, may be increased to 80mg/day max. Patients on diuretics: If possible, withdraw diuretic 2 to 3 days before starting; if not possible, start with 5mg/day and monitor serum K+ and renal function. Renal complication of diabetes mellitus: 10mg once a day; may be increased to 20mg once a day if necessary. Renal impairment, ccQ10ml/ min, initially 2.5mg; 10QccQ30ml/min, initially 2.55mg; 31QccQ80ml/min, initially 5-10mg/day. Q Not recommended. D History of angioedema associated with prior ACE inhibitor treatment, hereditary or idiopathic angioedema, pregnancy, lactation. B Caution: Acute MI (renal dysfunction, do not use), mitral stenosis and LV outflow obstruction, aortal stenosis, hypertrophic myocardiopathy, bilateral renal artery stenosis or artery stenosis in a single kidney (strict supervision with low doses; careful dose adjustment), preexisting renal impairment (monitor blood K+ and creatinine concentrations), major surgery, anaesthesia, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately), anaphylactoid reactions in haemodialysis patients or during desensitisation treatment, acute renal insufficiency in patients with HF (usually reversible), hepatic insufficiency, neutropenia/ agranulocytosis, cough. ATECOR Rowex C Not recommended: Lithium. Caution: ATENOGEN Antigen 3MO Diuretics, K+ sparing diuretics, K+ supplements, 3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, salt substitutes containing K+, NSAIDs (incl. 100mg. White scored film-ctd tabs. 25mg-30, Cardioselective b-blocker. Atenolol 25mg, 50mg, acetylsalicylic acid r 3g/day), other A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, 100mg. White, white, orange film-ctd tabs. antihypertensives, certain anaesthetics, tricyclic A5.77; 100, A18.67. marked AT/25, AT/50, AT/100, resp. All marked antidepressants and antipsychotic agents, A S Hypertension. with maker’s symbol. 25mg-28, 2.49; 50mg-28, sympathicomimetics, anti-diabetics. P 50mg once daily increasing to 100mg if A3.77; 100mg-28, A5.38. A Dizziness, headache, orthostatic effects required. (incl. hypotension), diarrhoea, vomiting, renal S Cardiac arrhythmias. Long-term Q Not recommended. dysfunction, impotence. prophylaxis after recovery from acute MI. Angina D See 2.4, b-blockers Drug Presc. Notes. pectoris. Essential hypertension. Ranbaxy P Arrythmias: 50-100mg daily. Prophylaxis BELLRAMIL ATECOR CT Rowex after recovery from MI: 100mg daily. Hypertension: 2MO 5MO 50mg daily increasing to 100mg daily if required. ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 Allow time to achieve full effects (1-2 weeks) Cardioselective b-blocker/ thiazide diuretic. hard cap. with resp. yellow, orange, maroon or before determining need to increase to 100mg Atenolol 50mg, chlorthalidone 12.5mg; atenolol blue cap /white body, imprinted with R on cap daily. Angina: 100mg daily as a single dose or as 100mg, chlorthalidone 25mg. Both white film-ctd and strength on body. Contain white to off-white 50mg twice daily. tabs. scored one side. 50/12.5-30, A4.85; 100/ granular powder. 2.5mg-30, A5.50; 5mg-30, Q Not recommended. 25mg-30, A6.97. A7.10; 10mg-30, A9.60. D See 2.4, b-blockers Drug Presc. Notes. S Hypertension. S Mild to moderate hypertension. P 1 daily. P Initially 1.25mg once daily. Increase dose ATENOMEL Clonmel Q Not recommended. incrementally at intervals of 1-2 weeks up to max D See 2.4, b-blockers Drug Presc. Notes. 3MO 10mg once daily. Maintenance: 2.5-5mg. If Cardioselective b-blocker. Atenolol 25mg, 50mg, response unsatisfactory at 10mg, combination ATENETIC Gerard 100mg. White tab. marked C23, C24, C25. 50 and treatment recommended. In diuretic treated 5MO 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; patients, discontinue diuretic 2-3 days before AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
45
2.4 HYPERTENSION
CIRCULATORY SYSTEM rhinitis gastro-intestinal disorders, arthritis, back pain, skeletal pain, haematuria, UTIs, chest pain, fatigue, flu-like symptoms, peripheral oedema, pain.
C Antihypertensives, cimetidine, quinidine, rifampicin, digoxin, cardiodepressants, adrenergic neurone blocking drugs, non-cardio selective b blockers, grapefruit juice. A Flushing, headache, fatigue, dizziness, BENETOR PLUS Daiichi Sankyo dry eyes, skin rash, oedema, hypersensitivity type jaundice (rare), gingival hyperplasia, 5MO gynaecomastia, impotence. Mood changes, MI, Angiotensin II antagonist/thiazide diuretic. Olmesartan medoxomil/HCTZ, 20mg/12.5mg, 20mg/ ischaemic pain (discontinue). 25mg. Round film-ctd tab. 20mg/12.5mg, reddishBETA-PROGRANE Tillomed yellow; 20mg/25mg, pinkish embossed with C22, 3MO C24 resp. 28, A17.82. S Essential hypertension in patients whose Non-cardioselective b-blocker. Propranolol (HCl) blood pressure is not adequately controlled on 80mg, 160mg. White hard prolonged.-release cap. olmesartan medoxomil alone. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)P Initially, 20mg/12.5mg once daily. If BP 28, A6.27. not adequately controlled 20mg/25mg once daily S Hypertension, adjuct in thyrotoxicosis, (max. daily dose). prophylaxis of upper GI bleeding in patients with Q 18 years and under, not recommended. portal hypertension and oesophageal varices. D Severe renal/hepatic impairment. P Hypertension: Initially 160mg daily Cholestasis and biliary obstructive disorders. taken morning or evening; may be increased if Refractory hypokalaemia, hypercalcaemia, necessary in 80mg increments. All other hyponatraemia and symptomatic hyperuricaemia. indications: 80mg every morning or evening; may Pregnancy, lactation. be increased if necessary to 160mg daily up to B Intravascular volume depletion (risk of 240mg daily. Portal hypertension: Target 25% reduction in resting heart rate; max. dose 320mg symptomatic hypotension). Impaired renal once daily. function (monitor serum K+, uric acid and Q Not recommended. creatinine levels). Caution: Renovascular D See 2.4, b-blockers Drug Presc. Notes. hypertension, hyperkalaemia, diabetes, aortic or mitral value stenosis, obstructive hypertrophic BETALOC AstraZeneca cardiomyopathy, ischaemic heart or cerebrovascular disease. Not recommended: Recent 3 M O kidney transplant, hepatic impairment, primary Cardioselective b-blocker. Metoprolol tartrate aldosteronism. Monitor serum electrolytes 50mg white tab. scored and marked A/BB; 100mg regularly. white tab. scored and marked A/ME. 50mg-100, C Not recommended: K+ suppl., K+ sparing A2.11; 100mg-100, A3.91. diuretics, lithium. Caution: Amifostine, alcohol, S Hypertension. Adjunct in thyrotoxicosis. barbiturates, narcotics, antidepressants, NSAIDs, P Hypertension, initially 100mg daily, other antihypertensives, baclofen, Ca++ salts, increasing if required to 400mg daily in one or cholestyramine/colestipol resins, digitalis two divided doses. Thyrotoxicosis, 50mg four times glycosides, class Ia and III antiarrhythmics, some daily. antipsychotics, non-depolarizing skeletal muscle Q Not recommended. relaxants, anticholinergics, antidiabetics, bD See 2.4, b-blockers Drug Presc. Notes. BENETOR Daiichi Sankyo blockers, diazoxide, pressor amines, probenecid, 2MO Niche sulfinpyrazone, allopurinol, amantadine, cytotoxic BIOCARD Angiotensin II antagonist. Olmesartan medoxomil agents, salicylates, methyldopa, cyclosporine, 3MO 10mg, 20mg, 40mg. White, film-ctd tabs. with C13, tetracyclines. a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, C14 and C15 resp. embossed on one side. 10mg, A Dizziness, fatigue, bronchitis, cough, 25mg. Round bevel edged tabs. (3.125mg), scored 20mg: circular; 40mg: oval. 10mg-28, A14.74; pharyngitis, rhinitis, GI disorders, arthritis, on one side (25mg). Oval tab., marked S2 on one 20mg-28, A17.70; 40mg-28, A22.29. haematuria, UTI, pain, fatigue, flu-like symptoms, side (6.25mg scored) or S3 on one side (12.5mg S Essential hypertension. peripheral oedema. scored). All slightly biconvex, white. 3.125mg-28, P Initially, 10mg once daily. Optimal dose, A5.09; 6.25mg-28, A6.23; 12.5mg-28, A7.45; 20mg once daily. Max.: 40mg, daily. Mild to BETA-ADALAT Bayer Schering 25mg-28, A8.32. moderate renal impairment: Max., 20mg once 3MO S Hypertension daily. P Initially, 12.5mg once daily for 2 days. Cardioselective b-blocker/class II Ca++ antagonist. R Max., 20mg once daily. Thereafter, 25mg once daily. Max. 50mg once Q 18 years and under, not recommended. Atenolol 50mg, slow-release nifedipine 20mg. D Pregnancy, lactation. Biliary obstruction. Reddish-brown cap. marked with name and Bayer daily or in divided doses. Dose titration at 2-week intervals. A 11.87. cross. 28 (Cal/Pk), B Hepatic impairment and severe renal Q Under 18 years, not recommended. S Hypertension, where b-blocker or impairment: Not recommended (limited D See 2.4, b-blockers Drug Presc. Notes. calcium antagonist monotherapy is inadequate. experience). Intravascular volume depletion, renovascular hypertension, kidney transplantation, P 1 daily, increasing to 1 every 12 hours if NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction. necessary. hyperkalaemia, lithium, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, R Max. 1 daily. BISOCOR Niche Q Not recommended. primary aldosteronism, ethnic differences, other 3MO D Women of child bearing potential. HF. conditions stimulating renin-angiotensin2nd or 3rd degree heart block. Cardiogenic shock, Cardioselective b-blocker. Bisoprolol hemifumarate aldosterone system, ischaemic heart disease or 5mg, 10mg. Pale-yellow scored tab. marked BI and ischaemic cerebrovascular disease. use in conjunction with other cardio-depressant 5, beige scored tab. marked BI and 10. 5mg-28, C K+ suppl., K+ sparing diuretics and drugs, severe bradycardia, acute angina attacks, A5.28. 10mg-28, A5.99. lithium (not recommended). NSAIDs and unstable angina pectoris, severe aortic stenosis, angiotensin II antagonists (monitor renal function during or within one month of MI, wheezing, S Hypertension. at beginning of treatment and ensure regular asthma, severe renal failure. Pregnancy, lactation. P 5-20mg once daily. Usually 10mg once hydration). Well tolerated additive reduction in BP B Cardiac conduction defects or poor daily. with HCTZ. Q Not recommended. cardiac reserve. OAD. Renal or hepatic A Dizziness, bronchitis, cough, pharyngitis, impairment. Diabetes. Anaesthesia. Elderly. D See 2.4, b-blockers Drug Presc. Notes.
initiating. Patients with congestive HF, start treatment at 1.25mg under close medical supervision in hospital. R Caution Q Not recommended. D History of angioneurotic oedema, haemodynamically relevant renal artery stenosis (bilateral or unilateral in single kidney). Aortic or mitral valve stenosis or outflow obstruction. Hypotensive or haemodynamically unstable patients. Pregnancy, lactation. B Renal impairment risk; assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and saltdepletion, anaesthesia. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, Hb content and platelet count, hyperkalaemia. Avoid haemodialysis using high flux membranes and LDL apheresis with dextran sulphate. C Caution: Diuretics or other antihypertensives, K+ sparing diuretics, K+ supplements, antidiabetics, NSAIDs, lithium, allopurinol, immunosuppressants and other substances that may change the blood picture. A Hypersensitivity reactions, eosinophilia, raised antinuclear antibodies titres, sleep disorders, depressed mood, anxiety, dizziness, disturbances of balance, nervousness, restlessness, tremor, confusion, loss of appetite, paraesthesiae, conjunctivitis, symptomatic hypotension, syncope, MI or cerebrovascular accident possibly secondary to severe hypotension, chest pain, palpitations, rhythm disturbances, angina pectoris, vasculitis, dry tickling cough, rhinitis, sinusitis, bronchitis, bronchospasm, GI disorders, cutaneous and mucosal reactions, muscle cramps, muscle and joint pains, impaired renal function, impotence, decreased libido, taste change/reduction/loss, fever headache, fatigue, malaise, increases in blood urea, nitrogen and serum creatinine, decreased serum Na+, increased serum K+.
46
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
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MIMS Ireland
2.4 HYPERTENSION
CIRCULATORY SYSTEM
D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. BISOP Rowex Combinations with floctafenine and sultopride. B See 2.4, b-blockers Drug Presc. Notes. 3MO Iodated contrast products. Driving/operating Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Resp. yellow or apricot, round film-ctd machinery. Contains lactose. tablet with a cross score encoded BIS and strength C See 2.4, b-blockers Drug Presc. Notes. Anti-cholinesterastic drugs. Amifostine. NSAID. on one side. 5mg-28, A5.34;10mg-28, A6.01. A See 2.4, b-blockers Drug Presc. Notes. S Hypertension. Headache. P Should be taken with liquid (not chewed), in the morning. Initially 5mg; usual dose BLOPRESS Takeda 10mg once daily; max 20mg/day. 2MO Q Not recommended. D Acute HF or during episodes of HF Angiotensin II antagonist. Candesartan cilexetil decompensation requiring IV inotropic therapy. 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white nd rd Cardiogenic shock. AV block of 2 or 3 degree tab. 4mg: Round white tab. with single score line on both sides. 8mg: Round pale pink tab. with (without a pacemaker). Sick sinus syndrome. single score line on both sides. 16mg: Round light Sinoatrial block. Bradycardia (Q 60 beats/min) pink tab. with one convex side embossed with 16 before start of therapy. Hypotension (systolic BP and one scored flat side. 32mg: Round light pink Q 100mmHg). Severe bronchial asthma or severe tab. with convex sides, debossed 32 on one side COPD. Late stages of peripheral arterial occlusive and scored on the other. 2mg-7, A1.81; 2mg-28, disease and Raynaudâ&#x20AC;&#x2122;s syndrome. Untreated A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, phaeochromocytoma. Metabolic acidosis. Pregnancy (unless necessary), lactation. 15.81; 16mg-28, A19.22; 32mg-28, A24.63. B Regular monitoring required. Withdraw S Essential Hypertension. gradually. Caution: Bronchospasm, diabetes P Initially 8mg once daily. Usual mellitus with large fluctuations in blood glucose maintenance dose: 8mg, may be increased to (hypoglycaemia symptoms can be masked), strict 16mg. If blood pressur not sufficiently controlled fasting, ongoing desensitisation therapy, AV block after 4 weeks, may be increased to 32mg. Renal of 1st degree, Prinzmetalâ&#x20AC;&#x2122;s angina, peripheral impairment (incl. haemodialysis) and intravascular arterial occlusive disease, general anaesthesia. In volume depletion: 4mg initially. Moderate hepatic bronchial asthma or other COPD, bronchodilating impairment: 2mg initially. therapy should be given concomitantly. Psoriasis: Q Safety and efficacy not established. Assess risk/benefit. Phaeochromocytoma: Do not D Pregnancy, lactation. Severe hepatic admin. until after a-receptor blockade. Symptoms impairment and/or cholestasis. of thyrotoxicosis may be masked. Contains lactose. B Not recommended: Primary Driving/operating machinery ability (at start of hyperaldosteronism. Caution: Haemodynamically treatment, with alcohol). relevant aortic mitral valve stenosis, obstructive C Contra: Floctafenin, sultopride. Not hypertrophic cardiomyopathy, severe CHF, recommended: Ca++ antagonists (verapamil type underlying renal disease (incl. renal artery and diltiazem type), class I antiarrhythmics, stenosis), haemodialysis (carefully titrate with centrally acting antihypertensives. Caution: Ca++ thorough monitoring of BP), anaesthesia and (dihydropyridine type (e.g. felodipine, surgery. Monitor renal function, serum K+ and creatinine levels (HF, elderly, renal impairment, amlodipine), class-III antiarrhythmics (e.g. concomitant ACE inhibitor). Hypotension may amiodarone), topical b-blocking agents (e.g. eye occur. Contains lactose. drops for glaucoma treatment), C Possible interaction with NSAIDs. parasympathomimetics, insulin and oral Antihypertensive effect may be enhanced by other antidiabetics, anaesthetic agents, digitalis antihypertensives. K+ -sparing diuretics, K+ glycosides, NSAIDs, b-sympathomimetics that supplements, salt substitutes containing K+, or activate both b and a-adrenoreceptors (e.g. other medicinal products that may increase K+ noradrenaline, adrenaline), antihypertensives, levels, lithium. tricyclic antidepressants, barbiturates, phenothiszines. Mefloquine, MAOIs (except MAO- A Respiratory infection, dizziness/vertigo, headache. B inhibitors). A Bradycardia, worsening of heart failure, BLOPRESS PLUS Takeda dizziness, headache, GI complaints, feeling of coldness or numbness in extremities, hypotension, 5 M O asthenia, fatigue. Angiotensin II antagonist/thiazide diuretic. Candesartan cilexetil/HCTZ 8mg/12.5mg, 16mg/ BISOPINE Pinewood 12.5mg, 32mg/12.5mg, 32mg/25mg. Resp. white, 3MO light pink, light yellow or light pink scored oval Cardioselective b-blocker. Bisoprolol hemifumarate tabs marked with strength and C (8mg/12.5mg, 5mg, 10mg. Resp. pale yellow or beige mottled 16mg/12.5mg), C1 (32mg/12.5mg) or C2 (32mg/ tabs. marked BI above breakline 5 or 10 below. 25mg). 8mg/12.5mg-28, A15.81; 16mg/12.5mg-28, A19.22; 32mg/12.5mg-28, A24.63; 32mg/25mg-28, 5mg-28, A5.90; 10mg-28, A6.65. A24.63. S Hypertension. P 5-20mg once daily, usually 10mg once S Essential Hypertension, where daily. Upon discontinuation, diminish slowly by monotherapy with candesartan cilexetil or HCTZ is weekly halving dose. Severe renal impairment: not sufficient. Max dose 10mg daily. P 1 tab. once daily. Titrate candesartan R Lowest dose recommended. Regular dose before switching to Blopress Plus (esp. in monitoring during initiation of treatment. renal impairment and volume depleted patients). Q Not recommended. When clinically appropriate direct switch from Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.
48
monotherapy to Blopress Plus may be considered. Mild-moderate renal impairment: Initially 4mg candesartan. Mild to moderate hepatic impairment: Initially, 2mg candesartan. Q Safety and efficacy not established. D Pregnancy, lactation. Severe hepatic impairment and/or cholestasis. Severe renal impairment. Refractory hypokalaemia and hypercalcaemia. Gout. B Not recommended: Primary aldosteronism. Renal impairment: Monitor K+, creatinine and uric acid levels. Recent kidney transplant (no data). Caution: Renal artery stenosis, impaired hepatic function, progressive liver disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Correct intravascular volume and/or Na+ depletion before treatment. Hypotension may occur during anaesthesia and surgery. Monitor serum electrolytes. Discontinue before parathyroid function tests. May impair glucose tolerance. Hypersensitivity reactions to HCTZ may occur (particularly if history of allergy or bronchial asthma). Exacerbation or activation of SLE reported with thiazides. Contains lactose. C Caution: Skeletal muscle relaxants, drugs associated with K+ loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G Na+, salicylic acid derivates), Ca++ supplements, Vitamin D, bblockers, diazoxide, anticholinergics , amantadine, cytotoxic drugs, steroids, adrenocorticotropic hormone (ACTH), antidiabetics (incl. insulin), pressor amines, iodinated contrast media, lithium, K+ -sparing diuretics, K+ supplements, salt substitutes containing K+, or other medicinal products that may increase K+ levels. Possible interaction with NSAIDs. Antihypertensive effect may be enhanced by other antihypertensives. Absorption of HCTZ reduced by colestipol or cholestyramine. A Dizziness/vertigo, hyperglycaemia, hyperuricaemia, electrolyte imbalance (incl. hyponatraemia and hypokalaemia), glycosuria, weakness, increases in cholesterol and triglycerides.
BYTRITE
Helsinn Birex
2MO ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. Opaque hard gelatin caps. Yellow, light orange, pink and blue cap with white bodies printed 93 and 7209, 7210, 7211, 7212 resp. 1.25mg-28, A2.48; 2.5mg-28, A3.53; 5mg-28, A4.94; 10mg-28, A6.73. S Hypertension. P Initially, 2.5mg once a day; should be increased at intervals of 1-2 weeks, up to max. 10mg once a day. Consider combination treatment if 10mg not effective. Diuretic treated patients: Discontinue diuretic 2-3 days prior to therapy. If diuretic cannot be discontinued, start with 1.25mg. Renal impairment: See SPC. Q Not recommended. D History of angioneurotic oedema relating to previous ACE inhibitor treatment. Pregnancy, lactation. Use in children. B Aortic stenosis, outflow obstruction (not recommended). Assess renal function prior to and during treatment. Impaired renal/liver function; reduce dose and monitor closely. Haemodialysis using high-flux membranes (avoid). Correct volume/salt depletion before initiating therapy. Collagen vascular disease; monitor white blood cell counts and protein levels in urine.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HYPERTENSION 2.4
SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, or leukopenic drugs monitor white cell count and urinary protein. Anaesthesia. Contains lactose. C K+sparing diuretics or K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, BYZESTRA Ergha probenecid, immunosuppressants. A Rash, loss of taste, cough. Rarely 2MO neutropenia, agranulocytosis, proteinuria. Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. White tabs marked LSN followed by strength. CAPOZIDE BMS 2.5mg-28, A3.13; 5mg-28, A4.41; 10mg-28, A5.44; 5MO 20mg-28, A6.25. ACE inhibitor/thiazide diuretic. Captopril 50mg, S Arterial hypertension alone or concomitantly with other antihypertensive agents. HCTZ 25mg. White scored tab. marked SQUIBB Renal disease in hypertensive patients with type 2 390. 28, A7.29. 5MO diabetes mellitus and incipient nephropathy. P Arterial hypertension: Initially, 5-10mg ALSO HALF CAPOZIDE Captopril 25mg, HCTZ in the morning; titrate at minimum 3 week 12.5mg. White scored tab. marked SQUIBB 536. intervals; maintenance, 20mg once daily; max. 28, A5.15. 80mg once daily. Renal complications of diabetes S Mild to moderate hypertension in mellitus: 10mg once daily; may be increased to patients who have been stabilised on captopril 20mg once daily to achieve BPQ90mmHg. and a thiazide diuretic. Moderate renal impairment: As per elderly. P 1 daily. R Initially, 2.5mg in the morning; maintenance usually 5-10mg daily; max. 20mg daily. Q Not recommended. D Angioneurotic oedema, severe renal impairment, aortic or mitral valve stenosis, hypertrophic cardiomyopathy, haemodynamically unstable patients after acute MI, SBPR100mmHg. Lactation, pregnancy. Permanent haemodialysis, cardiogenic shock. B Initiate therapy/adjust dose in hospital in: High risk for severe acute hypotension, e.g. vol/ salt depletion, pre-existing hypotension, renovascular hypertension, renal artery stenosis, unstable cardiac failure, renal impairment, highdose vasodilator therapy, patients r70 years, cerebrovascular disease, malignant hypertension. Discontinue or reduce diuretic therapy for 2-3 days before treatment and start with 2.5mg daily. Primary hyperaldesteronism (not recommended). Hypertrophic cardiomyopathy, surgery; caution. C Caution: K+-sparing and other diuretics, K+ suppls, NaCl, antihypertensives, analgesics, antiinflammatory agents, lithium, alcohol, anaesthetics/ narcotics/ hypnotics, sympathomimetics, oral antidiabetics, antacids, NSAIDs. A Hypotension, headache, tiredness, dry cough, sore throat, bronchitis, nausea, rash, angioneurotic oedema, hyperkalaemia. Hyperkalaemia, angioneurotic oedema have been reported rarely. Surgery/anaesthesia. Driving or operating machines. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness and headache, GI disturbances, cough, skin/mucosal reactions.
CAPOTEN
Q Not recommended. D Aortic stenosis. Pregnancy, lactation. See SPC. B With renal impairment, collagen vascular disease, immunosuppressant therapy, or leukopenic drugs monitor white cell count and urinary protein. Anaesthesia. Diabetes. Hepatic impairment. Gout. C Lithium, sulphonamide-derived drugs, NSAIDs, allopurinol, procainamide, probenecid, immunosuppressants, vasodilators, clonidine, K+sparing diuretics, K+suppl., antihypertensives. A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria.
CAPTOR
Rowex
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (6.25mg, 12.5mg); white tabs. cloverleaf form with facet and quarter scored both sides (25mg, 50mg). 12.5mg-60, A8.54; 100, A14.25; 25mg-60, A9.73; 100-A16.22; 50mg-60, A16.60; 100, A27.67. S Hypertension.
BMS
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Mottled white scored tab. marked S, mottled white quarter scored square tab. coded 452 and SQUIBB, mottled white oval tab. coded 482 and SQUIBB. 12.5mg-56, A4.79; 25mg-56, A5.46; 84, A24.72; 50mg-56, A9.31; 84, A42.12. S Hypertension. P Initially 25mg or 50mg once daily. Add a diuretic if required after 2-4 weeks. Usual max. 100mg daily in single or divided doses. Elderly and those patients already on diuretic therapy, initially 25mg once daily and titrate according to response. Renally impaired, initiate at a lower dose e.g. 12.5mg once daily and titrate according to response. Q Contact manufacturer. D Aortic stenosis. Pregnancy, lactation. See AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
49
2.4 HYPERTENSION
CIRCULATORY SYSTEM
P Initially, 25-50mg daily in two divided doses; may be increased with intervals of at least 2 weeks, to 100-150mg/day in two divided doses. With diuretics, once-daily dosing regimen may be appropriate. Renal impairment, initiate at a lower dose (see SPC). R Initially 6.25mg twice daily. Q Initially 0.3mg/kg, or 0.15mg/kg in infants or renal dysfunction. Generally 3 times a day. D Angioneurotic oedema. Pregnancy, lactation. B Renal impairment, renal artery stenosis, LV valvular and outflow tract obstruction, collagen vascular disease, patients at risk for hyperkalaemia, diabetes, hepatic impairment, anaesthesia. Neutropenia/ agranulocytosis, proteinuria. Contains lactose. C K+sparing diuretics, K+suppl., diuretics, other anti hypertensive agents, lithium, TCAs, allopurinol, procainamide, cytostatic or immunossupressive drugs, NSAIDs, sympathomimetics, antidiabetics. A Pruritus, rash, alopecia, dry cough, loss of taste, dizziness, sleep disorders, GI disorders.
ALSO CARDURA Doxazosin mesylate (equiv. doxazosin) 1mg, 2mg. White round and oblong biconvex tabs. marked CN1 and CN2 resp. with Pfizer logo on reverse. 2mg tab. scored. 1mg-28 (Cal/Pk), A4.93; 2mg-28, A6.57. P Initially 1mg once daily; may be increased to 2mg once daily, then 4mg, 8mg, up to max. 16mg daily. Titration interval, 1-2 weeks. Usual recommended dose, 2-4mg once daily. Q Under 12 years, not recommended. D Lactation. Cardura XL: History of GI or oesophageal obstruction, decreased lumen diameter of GI tract. B Pregnancy. Renal/hepatic impairment, LV failure, elderly. Driving/using machines. Postural hypotension (warn patients), cataract surgery. Cardura tabs contain lactose. C Caution: PDE-5 inhibitors. A Vertigo, nausea, asthenia, oedema, fatigue, malaise, dizziness, headache, postural dizziness, somnolence, syncope, rhinitis. Most common reactions with Cardura XL of postural type.
2NO
CARSEM XL
5MO
CAPTOR-HCT
2MO
Rowex
Teva
Selective a-blocker. Doxazosin (as mesilate), 4mg. 5MO White, round biconvex film-ctd prolonged-release ACE inhibitor/thiazide diuretic. Captopril 50mg, tab. with DL bossing on one side. 28, A12.82. HCTZ 25mg. Off-white scored tab. 30, A13.00. S Essential hypertension: Not for 1st-line 5MO treatment, may be used as monotherapy in ALSO CAPTOR-HCT 25/12.5 Captopril 25mg, HCTZ patients who fail to respond/have A contraindications to other agents; as 2nd or 3rd 12.5mg. Off-white scored tab. 30, 9.18. S Hypertension not adequately controlled line treatment in combination with other by captopril alone or HCT alone. antihypertensives. P Maintenance, 50/25mg once daily in the P 4mg once daily. May be increased to morning. Renal impairment, salt/vol. depletion, 8mg once daily. diabetes: 25/12.5mg once daily. Q Not recommended. R 25/12.5mg once daily. D Benign hyperplasia and concomitant Q Not recommended. congestion of upper urinary tract, chronic UTIs, D Angioneurotic oedema. Severe renal or bladder stones. Overflow bladder, anuria, hepatic impairment. Pregnancy, lactation. progressive renal impairment. History of B Renal impairment, renal artery stenosis, oesophageal or GI obstruction, decreased GI tract LV valvular and outflow tract obstruction, collagen lumen diameter. Lactation. Pregnancy (unless vascular disease, patients at risk for clearly needed). hyperkalaemia, diabetes, hepatic impairment, B Severe hepatic impairment, not anaesthesia. Electrolyte imbalance, gout, recommended. Monitor for postural effects when neutropenia/ agranulocytosis, proteinuria. Contains initiating therapy. Caution: Acute heart disease, lactose. mild-moderate hepatic impairment, Diabetic C K+sparing diuretics, K+suppl., diuretics, Autonomic Neuropathy, cataract surgery. Not for vasodilators, lithium, TCAs, allopurinol, use as single agent in patients with 1 or more procainamide, cytostatic or immunossupressive additional cardiovascular disease risk factors. May drugs, NSAIDs, sympathomimetics, antidiabetics. influence plasma renin activity and urinary Amphotericin B (parenteral), carbenoxolone, excretion of vanillylmandelic acid. Driving/ corticosteroids, ACTH or stimulant laxatives, Ca++ operating machinery. salts, cardiac glycosides, cholestyramine resin and C Not recommended: Tadalafil. Caution: colestipol, nondepolarising muscle relaxants, drugs Sildenafil, vardenafil, other antihypertensives, nonassociated with torsades de pointes. steroidal antirheumatics, estrogens, A Pruritus, rash, alopecia, dry cough, loss sympathomimetics, medicinal products which may of taste, dizziness, sleep disorders, GI disorders. influence hepatic metabolism (e.g. cimetidine). A Apathia, muscle cramps, fatigue, CARDURA XL Pfizer malaise, headache, somnolence, accomodation disturbances, palpitations, chest pain, giddiness, 2MO dizziness, oedema, orthostatic dysregulation, Selective a-blocker. Doxazosin 4mg, 8mg. White dyspnoea, rhinitis, GI disorders, frequent desire to prolonged-release round biconvex tabs. with hole micturate, increased micturation, delayed in one side, marked CXL4 or CXL8. 4mg-28 (Cal/ ejaculation, asthenia. Pk), A9.05; 8mg-28 (Cal/Pk), A37.54. S All grades of hypertension as Boehringer Ing. monotherapy or with thiazide diuretic, b-blocking CATAPRES 2MO drugs, Ca++ antagonists or ACE inhibitors. P Initially 4mg once daily. If necessary, Central a-agonist. Clonidine (HCl) 100mcg, may be increased to 8mg once daily (max. dose). 300mcg. White round tabs marked O1C/O1C and Q Under 12 years, not recommended. O3C/O3C resp. on one side and maker’s symbol on 2MO reverse. 100mcg-100, A7.89; 300mcg-100, A18.37.
50
ALSO CATAPRES INJECTION Clonidine 150mcg/ml. Sln for inj. in 1ml amp. 5, A1.69. S Hypertension that has failed to respond adequately to other anti-hypertensives. P 50-100mcg three times daily increasing gradually. Optimal dose 300-1200mcg/day in divided doses. Q Not recommended. D Severe bradyarrhythmia resulting from either sick sinus syndrome or AV block of 2nd or 3rd degree. Pregnancy, lactation. B Depression, Raynaud’s disease, other peripheral vascular occlusive disease, cerebrovascular or coronary insufficiency, mild to moderate bradyarrhythmia, polyneuropathy, constipation, HF, renal insufficiency. Withdraw gradually. Contains lactose. C TCAs, a blockers, b other hypertensives, CNS depressants, NSAIDs, digitalis glycosides. A Sedation, dry mouth, drowsiness.
CENTYL
LEO Pharma
Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, circular, flat, slightly bevelled tabs. 2.5mg-500, A21.25; 5mg-100, A6.38; 500, A31.88. S Hypertension, alone or in combination with other antihypertensives. P 2.5-5mg once daily. D Severe electrolyte imbalance. Severe renal/hepatic impairment. Addison’s disease, established gout, ulcer or GI tract obstruction. B K+suppl. may be required (monitor electrolytes). Renal/hepatic impairment, obstruction of urinary tract, disorders altering electrolyte balance. May: Cause hyperuricaemia and aggravate gout; activate SLE. Diabetes. Pregnancy, lactation. Contains lactose. C Contra: Lithium. Cardiac glycosides, hypotensive agents (adjust dose). TCAs, hypoglycaemic agents, NSAIDs, probenecid, cholestyramine, other drugs known to cause photosensitivity. A Headache, dizziness, fatigue, postural hypotension, GI disorders. Electrolyte disturbances (long term use).
CENTYL K
LEO Pharma
5MO Thiazide/K+suppl. Bendroflumethiazide 2.5mg, K+ Cl 573mg (7.7mmol K+) in slow -release wax core. Green, sugar-ctd, oval, modified release tab. 250, A31.10. S Hypertension alone or in combination with other antihypertensives. P 1-2 every morning. Q Not applicable. D Precoma associated with hepatic cirrhosis, Addison’s disease. Severe renal impairment. Hyperkalaemia. B Diabetes, renal impairment, obstruction of urinary tract; caution. Obstruction of small bowel, ulceration (discontinue if occurs). Pregnancy, lactation (only if essential). C K+sparing diuretics, lithium. Caution: Cardiac glycosides, antihypertensives. A Rash, photosensitivity, myopia aggravation, blood dyscrasias, gout, fatigue. Acute pancreatitis, hyperuricaemia, GI upset, oliguria, dizziness, headache, muscle pain, thirst, dry mouth. Vasculitis.
CIBACEN
Meda
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM HCTZ 12.5mg. Yellow, ovaloid, beveled edge, filmctd tablet, debossed with NVR on one side and CTI on the reverse. 28, A32.24. P 1 daily, with fluid. Start with lower strength (320mg/12.5mg) and continue for at least 4-8 weeks before starting treatment with 320mg/ 25mg strength. Max. effect within 4-8 weeks. If no relevant additional effect, consider dose reduction and treatment with an additional or alternative antihypertensive. Q Under 18 years, not recommended. D Severe hepatic/renal impairment, anuria, biliary cirrhosis, cholestasis, dialysis, refractory hypokalaemia, hyponatraemia, hypercalcaemia, symptomatic hyperuricaemia. Pregnancy, lactation. B Vol. depletion and serum electrolyte changes (monitor); correct vol./ Na+ depletion before starting therapy. Not recommended: Renal artery stenosis, primary hyperaldosteronism, severe chronic HF. Caution: Aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, renal transplantation, hypersensitivity to other Ang II receptor blocking agents, allergy, asthma. Mild hepatic impairment without cholestasis, use 80/ 12.5 tab. only. May activate or exacerbate systemic lupus erythematosus. Altered glucose tolerance, CO-BETALOC Pharmacia raised serum levels of cholesterol, triglyceride, uric acid. 5MO C Drugs that increase/decrease serum K+ Cardioselective b-blocker/thiazide diuretic. levels, digitalis glycosides, drugs inducing torsades Metoprolol tartrate 100mg, HCTZ 12.5mg. White de pointes, antiarrhythmics, other scored tab. marked A/MH. 28, A8.96. antihypertensives, lithium, vit. D or Ca++ salts, S Mild to moderate hypertension. antidiabetics, b-blockers, diazoxide, drugs for the P 1-2 daily in single or divided doses. treatment of gout (allopurinol, probenecid, Q Not recommended. sulfinpyrazone), anticholinergics, pressor amines, D See SPC. amantadine, anionic exchange resins, cytotoxics, CO-DIOVAN Novartis NSAIDs, curare derivatives, cyclosporin, tetracyclines, alcohol, anaesthetics, sedatives, 5MO methyldopa. Angiotensin II antagonist/thiazide. Valsartan 80mg, A Diarrhoea, fatigue, nasopharyngitis. HCTZ 12.5mg. Light orange ovaloid film-ctd tab. marked HGH on one side and CG on reverse. 28, COAPROVEL sanofi-aventis/BMS A17.80. 5MO S Hypertension where monotherapy Angiotensin II antagonist/thiazide. Irbesartan/HCTZ proves inadequate. 150mg/12.5mg; 300mg/12.5mg; 300mg/25mg. P 1 daily. Mild to moderate hepatic Peach, peach, pink tabs marked 2875, 2876, 2788 impairment without cholestasis: Max. valsartan resp. All: Biconvex, oval, film-ctd marked with a 80mg daily. heart on reverse. 150/12.5mg-28, A18.33; 300/ Q Under 18 years, not recommended. 12.5mg-28, A24.74; 300/25mg-28, A24.71. 5MO S Essential hypertension in those ALSO CO-DIOVAN 160MG/12.5MG Valsartan inadequately controlled by either agent alone. 160mg, HCTZ 12.5mg. Dark red, ovaloid film-ctd. P 1 x 150/12.5mg tab. once daily where tab. Imprinted HHH on one side and CG on the irbesartan 150mg or HCTZ taken alone do not other. 28 (2x14): A23.87. control BP. Alternatively, 1 x 300mg/12.5 tab. once P 1 daily. daily where irbesartan 300mg taken alone or Q Under 18 years, not recommended. CoAprovel 150mg/12.5mg do not control BP. 1 x 5MO 300mg/25mg once daily may be admin. in patients ALSO CO-DIOVAN 160MG/25MG Valsartan 160mg, insufficiently controlled by CoAprovel 300mg/ HCTZ 25mg. Brown, ovaloid tab. marked with HXH 12.5mg. Max: 300mg/25mg once daily. on one side and NVR on reverse. 28, A24.33. Q Under 18 years, not recommended. P 1 daily. Start with 160mg/12.5mg for D Severe renal impairment. Refractory min. 4-8 weeks. hypokalaemia, hypercalcaemia. Severe hepatic Q Under 18 years, not recommended. impairment, biliary cirrhosis, cholestasis. 5MO Pregnancy. ALSO CO-DIOVAN 320MG/12.5MG Valsartan B Correct volume/salt depletion before 320mg, HCTZ 12.5mg. Pink, ovaloid, beveled edge, initiating therapy. Renal impairment: Monitor K+, film-ctd tab., debossed with NVR on one side and creatinine and uric acid serum levels regularly. HIL on the reverse. 28, A29.13. Kidney transplantation, no data. Caution: Hepatic P 1 daily with fluid. When clinically impairment; renal artery stenosis; aortic or mitral appropriate direct change from monotherapy to stenosis, or obstructive hypertrophic the fixed dose combination may be considered. cardiomyopathy; diabetics; severe CHF, ischemic Max. effect within 4-8 weeks cardiopathy or ischemic CVD. Primary Q Under 18 years, not recommended. aldosteronism, not recommended. Hyperuricaemia/ 5MO gout; hypercalcaemia; hypomagnaesemia; ALSO CO-DIOVAN 320MG/25MG Valsartan 320mg, hypersensitivity reactions, may occur. Monitor
2MO
ACE inhibitor. Benazepril (HCl) 5mg cap-shaped pale yellow film-ctd tab scored both sides and marked CG one side and LV on reverse. 10mg dark yellow film-ctd tab marked CG one side and HO on reverse. 5mg-28, A9.33; 10mg-28, A12.44. S Hypertension. P Initially 10mg once daily. Patients with severe renal impairment or HF, initially 5mg once daily. Maintenance, 10mg once daily; max. 40mg daily. Discontinue diuretic therapy for at least 3 days before commencing therapy. R Initially 5mg once daily. Titrate to 10mg once daily. Q Not recommended. D Pregnancy, lactation. History of angioedema. B Salt and/or volume depletion. Renal artery stenosis, renal impairment, surgery, anaethesia, CHF. C Other anithypertensives, K+suppl., K+sparing diuretics, lithium. A Headache, upper respiratory tract symptoms, dizziness, fatigue, musculoskelatal pain, cough, rhinitis, nausea, diarrhoea, rash.
HYPERTENSION 2.4 serum electrolytes regularly. May exacerbate or activate SLE. If inadvertently taken during pregnancy, skull and renal function should be checked with echography. Lactation not recommended (esp. newborn or preterm infants). Contains lactose. C Lithium, not recommended. Caution: Other antihypertensives, K+ sparing diuretics, K+ suppl., salt substitutes containing K+, digitalis glycosides, antiarrhythmics, NSAIDs, alcohol, antidiabetics, colestyramine, colestipol, corticosteroids, ACTH, muscle relaxants, antigout medicines, Ca++ suppl. or Ca++ sparing medicines, anticholinergics, amantadine, cytotoxic medicines. A Dizziness, nausea, vomiting, abnormal urination, fatigue. Increases in BUN, creatinine and creatinine kinase.
COVERSYL ARGININE
Servier
2MO ACE inhibitor. Perindopril arginine 5mg, 10mg. 5mg: Light green, rod-shaped scored film-ctd tab with a symbol. 10mg: Green, round, biconvex, film-ctd tab with heart on one side and symbol on reverse. 5mg-30, A14.12; 10mg-30, A22.59. S Essential hypertension as monotherapy or in combination with thiazide diuretics. P Initially, 5mg daily as single dose. After 4 weeks, increase to 10mg once daily if required. Discontinue diuretic 3 days beforehand. If not possible, commence with 2.5mg. Renal insufficiency, 2.5mg according to creatinine clearance. R Initially, 2.5mg once daily; increase to 5mg after 4 weeks, then 10mg if necessary. Q Not recommended. D ACE inhibitor hypersensitivity. History of angioneurotic oedema (previous ACE treatment), hereditary or idiopathic angioedema. Pregnancy, lactation. B Symptomatic hypotension may occur in patients with salt or volume depletion. Caution: Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.
COVERSYL ARGININE PLUS
Servier
5MO ACE inhibitor/antihypertensive diuretic. Perindopril arginine/indapamide, 5mg/1.25mg; 10mg/2.5mg White rod-shaped or round (resp.) tab. 5/1.25mg30, A19.67; 10/2.5mg-30, A31.47. S Essential hypertension. 5mg/1.25mg: When BP inadequately controlled on perindopril alone. 10mg/2.5mg: Substitution therapy, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. P 1 daily preferably in the morning before a meal. Q Not recommended. D History of angioedema (Quincke’s
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
51
2.4 HYPERTENSION
CIRCULATORY SYSTEM
R As per adults. q75 years, consider initiating therapy with 25mg. Q Not recommended: Q 6 years, GFR Q30ml/min/1.73m2, hepatic impairment. Hypertension: 25mg once daily in patients q20Q50kg; exceptionally, can be increased to 50mg once daily maximum. Patients q50kg, 50mg once daily; exceptionally can be adjusted to 100mg once daily maximum. Doses q1.4mg/kg (or q100mg) daily not studied in paediatric patients. COZAAR COMP MSD D Severe hepatic impairment. Pregnancy, lactation. 5MO B History of angioedema (closely monitor). Angiotensin II antagonist/thiazide. Losartan (K+)/ HCTZ 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg. Volume depletion may cause symptomatic or use Resp. yellow, white and yellow oval film-ctd tabs. hypotension (correct prior to initiating lower starting dose). Monitor K+ and cc. Caution: marked 717, 745 and 747 50/12.5mg-28, A18.32; Hepatic impairment, renal impairment, renal 100mg/12.5mg-28, A26.36; 100/25mg-28, A31.77. artery stenosis, primary aldosteronism (not S Hypertension; not usually appropriate recommended), ischaemic cardiovascular and for initial therapy. cerebrovascular disease, aortic or mitral valve P Start with 50mg/12.5mg once daily. If stenosis, obstructive hypertrophic cardiomyopathy. no response use 100mg/12.5mg or 100mg/25mg Monitor renal function regularly. No sufficient once daily (max. dose). therapeutic experience: HF with concomitant Q Not recommended. severe renal impairment, severe HF (NYHA class D Therapy resistant hypokalaemia or IV), HF and symptomatic life threatening cardiac hypercalcaemia. Severe hepatic impairment; cholestasis, biliary obstructive disorders. Refractory arrhythmias. Contains lactose. + C Not recommended: K sparing diuretics, hyponatraemia. Symtomatic hyperuricaemia/gout. K+ supplements or salts, ACE inhibitors. Caution: Severe renal impairment. Anuria. Pregnancy. Other antihypertensives, TCAs, antipsychotics, Lactation. B Not recommended: Hepatic impairment, baclofen, amifostine, fluconazole, rifampicin, lithium, NSAIDs. severe renal impairment. Caution: Renal disease and renal transplant recipients. Haemodynamically A Hypertension: Dizziness, vertigo. Patients with LV hypertrophy: dizziness, vertigo, significant obstructive valvular disease, asthenia/fatigue. Type 2 diabetes with renal cardiomyopathy. May occur: SLE, gout, disease: Dizziness, hypotension, asthenia/fatigue, angioedema, symptomatic hypotension, increased hypoglycaemia, hyperkalaemia. triglycerides, cholesterol and serum calcium, impaired glucose tolerance. Monitor serum DILTAM RETARD Rowex electrolytes. Contains lactose. 2MO + + sparing diuretics, K suppl. or salts, C K COZAAR MSD barbiturates, narcotics, alcohol, antidiabetics, other Class III Ca++ antagonist. Diltiazem (HCl) 90mg. 2MO White sust.-release tab. 60, A12.38. antihypertensives, colestyramine and colestipol Angiotensin II antagonist. Losartan (K+) 12.5mg, S Mild to moderate hypertension. resins, corticosteroids, pressor amines, muscle 50mg, 100mg. White film-ctd scored tab. marked P Initially 1 daily increasing to 2 daily if relaxants, lithium, NSAIDs (indometacin), 952, white film-ctd teardrop-shaped tab. marked required. rifampicin, fluconazole. 960. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg- A Insomnia, headache, dizziness, cough, Q Not recommended. 28, A30.80. D Pregnancy, lactation. Sick sinus upper respiratory infection, nasal congestion, 2MO sinusitis, sinus disorder, GI disorders, muscle cramp, syndrome, 2nd or 3rd degree AV block, marked ALSO COZAAR ORAL SUSPENSION Losartan K+, bradycardia, decompensated cardiac failure. back pain, leg pain, myalgia, asthenia, fatigue, 2.5mg/ml (reconstituted susp.). White to off-white chest pain, hyperkalaemia, mild reduction of B Mild bradycardia, prolonged PR interval. powder and cloudy, colorless solvent for oral susp. haematocrit and haemoglobin. Measure heart rate regularly in elderly and in 500mg/200ml, A50. patients with hepatic or renal impairment. S Essential hypertension in adults, children COZATAN Clonmel Diabetes. and adolescents 6-18 years. Reduction in risk of C b-blockers, digoxin, cimetidine, 2MO stroke in hypertensive adults with LV hypertrophy. diazepam, antihypertensives, anaesthetics. + Renal disease in adults with hypertension and type Angiotensin II antagonist. Losartan (K ), 50mg, A Anorexia, nausea, bradycardia, oedema, 100mg. Resp. round or oblong biconvex white 2 diabetes mellitus with proteinuria r 0.5g/day as rash, flushing, fatigue, AV block, headache, GI film-ctd tab. with breaking notch on both sides. part of antihypertensive treatment. disturbance. Can be divided into equal quarters or halves. P 50mg once daily. If necessary, increase 50mg-28, A9.54; 100mg-28, A16.03. to max. 100mg once daily (morning). May be DILZEM XL Cephalon S Essential hypertension. Renal disease in admin. with other antihypertensives (e.g. 2MO patients with hypertension and type 2 diabetes hydrochlorothiazide) Class III Ca++ antagonist. Diltiazem (HCl) 120mg, Q Under 6 years, not recommended. Over with proteinuria r0.5g/day as part of 180mg, 240mg. Prolonged release hard capsules antihypertensive treatment. 6 years: 20-50kg: 25mg once daily; may be P Hypertension: 50mg once daily; maximal marked with cap. strength and logo. 120mg-28, exceptionally increased to 50mg. q50kg: may be A8.39; 180mg-28, A12.44; 240mg-28, A16.06. effect attained 3-6 weeks after initiation of exceptionally increased to 100mg. Not therapy. May be increased to 100mg once daily (in S Angina pectoris, incl. Prinzmetalâ&#x20AC;&#x2122;s recommended: Hepatic impairment, glomerular 2 angina. Mild to moderate hypertension. the morning). Renal disease in diabetics: Initially filtration rate Q 30ml/min/1.73 m . 50mg once daily. May be increased to 100mg once P 180mg once daily increasing gradually, D Severe hepatic impairment. Pregnancy. daily based on BP response from one month after as necessary to 360mg once daily. B History of angiooedema (closely R Initially 120mg once daily, increasing initiation of therapy onwards. May be monitor). Volume depletion may cause + administered with other antihypertensives as well gradually. symptomatic hypotension. Monitor K and cc. Q Not recommended. as with insulin and other commonly used Hepatic impairment, renal impairment, renal 2MO hypoglycaemics. Intravascular volume depletion: artery stenosis, primary aldosteronism (not ALSO DILZEM SR Diltiazem (HCl) 60mg, 90mg, Consider 25mg once daily initially. Hepatic recommended), aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No 120mg. Prolonged release hard capsules marked impairment: Consider lower dose.
oedema) with previous ACE inhibitor therapy. Hereditary/idiopathic angioedema. Hepatic encephalopathy. Severe and moderate hepatic impairment. Hypokalaemia. Severe and moderate renal impairment . Dialysis patients. Untreated decompensated heart failure. Pregnancy, lactation. B Not recommended: Renal artery stenosis, single functioning kidney. Monitor WBC counts: Collagen vascular disease, immunosuppressant / allopurinol / procainamide therapy. May occur: Angioedema, anaphylactoid reactions during desensitisation / LDL apheresis / dialysis with high flux membranes, photosensitivity, increased gout attacks, hepatic syndrome. Monitor for clinicals signs of water depletion, monitor electrolytes. Caution: Na+ depletion (hypotension risk), elderly, atherosclerosis, severe cardiac insufficiency, diabetes, surgery (discontinue 1 day before), aortic stenosis, long Q-T interval. Risk of arterial hypotension and/or renal insufficiency. Contains lactose. C Not recommended: Lithium, K+ salts, K+sparing diuretics, antidiabetics, Caution: Baclofen, NSAIDs, TCAs, neuroleptics, corticosteroids, tetracosactide, other antihypertensives, allopurinol, cytostatic or immunosuppressive agents, systemic corticosteroids, procainamide, anaesthetics, diuretics, injectable gold, torsades de pointes inducing drugs, amphotericin B (by IV), glucocorticoids and mineralocorticoids (systemic route), tetracosactide, stimulant laxatives, cardiac glycosides, iodinated contrast media, Ca++, ciclosporin. A Paraesthesia, headache, dizziness, vertigo, vision disturbance, tinnitus, hypotension, dry cough, dyspnoea, GI disorders, rash, pruritus, maculopapular eruptions, muscle cramps, asthenia.
52
sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF, HF and symptomatic life threatening cardiac arrhythmias. Lactation (not recommended). Tabs contain lactose. C Rifampicin, fluconazole, NSAID, K+ sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, asthenia/fatigue, hyperkalaemia, hypoglycaemia.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM with cap.strength. 60mg-56, A8.12; 90mg-56, A12.16; 120mg-56, A13.90. P Initially 90mg twice daily, increasing gradually to 180mg twice daily. R Initially 60mg twice daily increasing gradually. Q Not recommended. D Pregnancy, lactation, women of child bearing potential. Sick sinus syndrome, 2nd or 3rd degree AV block, marked bradycardia, decompensated cardiac failure. Atrial fibrillation/ flutter with WPW. Concomitant dantrolene infusion. B Mild bradycardia, prolonged PR interval, diabetes, red. LV function, monitor patients with hepatic dysfunction and renal impairment. C Antihypertensives, halogenated anaesthetics, H2 agonists, digoxin. A Oedema, headache, dizziness, asthenia, bradycardia, flushing, 1st degree heart block.
HYPERTENSION 2.4 A Palpitation, tachycardia, vertigo, GI disorders, asthenia, chest/ back pain, peripheral oedema, myalgia, dizziness, headache, cough, pruritus, urinary incontinence, postural Rowex hypotension.
A Dizziness, rhinitis, GI disorders, headache, fatigue, malaise, oedema, somnolence, asthenia, dry mouth.
DOXANE XL 2MO
Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. embossed DL. 28, A12.66. S Essential hypertension. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg once daily. Taken as monotherapy or in combination with thiazide diuretics, badrenoceptor blocking agents, Ca++ antagonists or an ACE-inhibitor. Q Not recommended. D Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic UTIs or bladder stones. Overflow bladder, anuria or progressive renal insufficiency. History of DIOVAN Novartis oesophageal or GI obstruction or decreased lumen 2MO diameter of the GI tract or patients at increased Angiotensin II antagonist. Valsartan 80mg, 160mg, risk for such obstruction. Pregnancy (only if 320mg. Pale red, grey-orange and dark grey-violet benefit outweighs risk), lactation. B Not considered appropriate as first line film-ctd scored tabs. marked D/V, DX/DX and DC/ treatment in hypertension. Monitor on initiation DC resp. on one side and NVR on reverse. 80mg28, A17.80; 160mg-28, A23.02. 320mg-28, A29.13. (risk of postural effects). Caution: Acute heart disease; minor/moderate hepatic impairment, S Hypertension. diabetic autonomic neuropathy. Severe hepatic P Usually 80mg once daily, increasing if impairment, not recommended. Driving/ using necessary to 320mg (max) once daily. Mild to moderate hepatic impairment without cholestasis: machines. C Caution: NSAIDs, oestrogens, Max. 80mg daily. sympathomimetics, PDE-5 inhibitors. Q Under 18 years, not recommended. A Apathia, muscle cramps, fatigue, D Pregnancy, lactation. Severe hepatic impairment, biliary cirrhosis and cholestasis, severe malaise, headache, somnolence, accommodation disturbances, palpitations, chest pain, giddiness, renal impairment (cc Q10ml/min.), patients dizziness, oedema, orthostatic dysregulation, undergoing dialysis. Primary aldosteronism. dyspnoea, rhinitis, constipation, dyspepsia, B Correct volume/salt depletion before increased micturation (or desire to), delayed starting therapy. HF, recent MI; reduction in BP. ejaculation, asthenia. Renal artery stenosis, kidney transplantation, hepatic impairment, obstructive hypertrophic DOXATAN Clonmel cardiomyopathy, aortic and mitral valve stenosis. C Caution: K+suppl., K+ sparing diuretics, 2MO antihypertensives, lithium. Selective a-blocker. Doxazosin mesilate (equiv. doxazosin) 1mg white tab. marked D1; 2mg, 4mg DOXACAR XL Gerard white oblong scored tabs. marked D2 or D4. 1mg28, A7.92; 2mg-28, A10.54; 4mg-28, A13.06. 2MO S Essential hypertension. Selective a-blocker. Doxazosin (as mesilate) 4mg. P Initial dose 1mg once daily. If necessary, Prolonged release tab. White, round, biconvex the dosage may be increased to 8mg once daily tab. embossed DL. 28, A14.03. according to response. Max. 16mg daily. S Essential hypertension. Q Not recommended. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg 2 M O ALSO DOXATAN XL PROLONGED RELEASE once daily. Taken as monotherapy or in Doxazosin (as mesilate) 4mg. Prolonged release combination with thiazide diuretics, b++ adrenoceptor blocking agents, Ca antagonists or tab. White, round, biconvex tabs. marked with DL. A13.79. 28, an ACE-inhibitor. Q Not recommended. S Hypertension. As monotherapy or in D History of GI or oesophageal combination with thiazide diuretics, bobstruction (or risk of). BPH with urinary outflow adrenoceptor blocking agents, Ca++ antagonists or ACE inhibitors. obstruction, chronic UTIs or bladder stones. P Initially 4mg once daily swallowed Pregnancy (only if benefit outweighs risk), whole with water; may be increased to max. 8mg lactation. once daily. B Abnormally short transport time through GI tract may cause incomplete absorption. Q Under 12 years, not recommended. D History of GI or oesophageal Monitor on initiation (risk of postural effects). obstruction, or any degree of decreased lumen Caution: Acute heart disease; minor/moderate diameter of the GI tract. Pregnancy (only if hepatic impairment. Severe hepatic impairment, benefit outweighs risk), lactation. not recommended. Driving or operating B Caution: Impaired hepatic function. machinery. Introduction and adjustment. Initial dose: Excessive C Caution: Sildenafil or other PDE-5 hypotensive effect may occur. Driving or operating inhibitors. NSAIDs, oestrogens, symathomimetics, machinery. vanillylmandelic acid.
DOXEL
Pinewood
2MO Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. marked DL. 28, A13.36. S Hypertension. As monotherapy or in combination with thiazide diuretic, b-blocker, Ca++ antagonist or ACE inhibitor. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg once daily. Q Under 12 years, not recommended. D History of GI or oesophageal obstruction, or any degree of decreased lumen diameter of the GI tract. Pregnancy (only if benefit outweighs risk), lactation. B Acute heart diseases. Not recommended: Severe hepatic insufficiency. Caution: Mildmoderate hepatic insufficiency. Postural hypotension may occur particularly at start of therapy; driving / using machines. Pregnancy (only if benefit outweighs risk). Patients undergoing cataract surgery. C Caution: PDE-5 inhibitors. A Delayed ejaculation, apathia, muscle cramps, fatigue, malaise, headache, somnolence, accommodation disturbances, palpitations, chest pain, giddiness, dizziness, oedema, dyspnoea, rhinitis, constipation, dyspepsia, increased micturation or desire to, asthenia.
EMCOLOL
Gerard
3MO Cardioprotective b-blocker. Bisoprolol fumarate 5mg and 10mg. Yellow and orange heart-shaped, scored film-ctd tabs. resp. 5mg-28, A5.93; 10mg28, A6.65. S Hypertension P 5-20mg once daily. Usually 10mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
EMCOR
Daiichi Sankyo/Merck Serono
3MO Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Yellow and orange biconvex film-ctd heart-shaped scored tabs. 5mg-28, A3.56; 10mg28, A4.01. S Hypertension. P Usually 10mg once daily; max. 20mg daily. In some 5mg/day may be adequate. Final stage impairment of renal function or liver function: Max. 10mg once daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.
ENAP
Rowex
2MO ACE inhibitor. Enalapril maleate 5mg, 10mg, 20mg. White, red and orange tabs marked EN 5, EN 10 and EN 20 resp. All scored, oblong. 5mg-30, A7.55; 10mg-30, A10.58; 20mg-30, A12.57. S Hypertension. P Initially 5-20mg once daily. Maintenance usually 20mg; max. 40mg daily. Q Not recommended; see SPC.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
53
2.4 HYPERTENSION
CIRCULATORY SYSTEM
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54
side. 5mg/80mg-28, A20.21; 5mg/160mg-28, A26.08; 10mg/160mg-28, A26.88. S Essential hypertension where BP not controlled on amlodipine or valsartan monotherapy. P 1 daily. Use 10mg/160mg if not controlled with valsartan 160mg, or amlodipine 10mg or Exforge 5/160mg. Individual dose titration with components recommended. Q Under 18 years, not recommended. D Severe hepatic impairment, biliary cirrhosis or cholestasis. Severe renal impairment (GFR Q30ml/min/1.73m2), dialysis. Primary hyperaldosteronism. Pregnancy, lactation. B Moderate renal impairment, monitor K+ levels and creatinine. Caution: Vol/salt depletion (risk for hypotension), elderly, HF, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, hepatic impairment, biliary obstructive disorders. ENTRYDIL Orion Mild to moderate hepatic impairment without cholestasis, max. valsartan 80mg. 2MO C Lithium, drugs increasing K+ levels Class III Ca++ antagonist. Diltiazem 60mg. White (avoid). Caution: CYP3A4 inhibitors/ inducers, film-ctd scored caplet coded DL60. 100, A17.16. NSAIDS. Avoid alcohol. S Hypertension. A Headache, nasopharyngitis, influenza, P 30-120mg three times daily, usually oedema, fatigue, flushing, asthenia, hot flush. 60mg three times daily. Q Not recommended.
D Angioedema. Pregnancy, lactation. B Kidney transplantation (avoid), renal artery stenosis, aortic or mitral valve stenosis, diabetes, collagen vascular disease, surgery, renal impairment, jaundice (discontinue if occurs). Reduce dose of diuretic, if possible prior to therapy, as vol. depletion may cause symptomatic hypotension. Contains lactose. C Other anti-hypertensive agents, K+suppl., K+sparing and other diuretics, lithium, TCAs, antipsychotics, anaesthetics, sympathomimetics, antidiabetics, antacids, NSAIDs, alcohol, immunosuppressants, allopurinol, procainamide. A Blurred vision, dizziness, hypotension, headache, depression, cough, dyspnoea, asthenia, nausea, GI disorders, rash, angioneurotic oedema, serum creatinine increase, hyperkalaemia.
FLOLAN
2MO ALSO ENTRYDIL CR Diltiazem 90mg, 120mg. Modified release white scored film-ctd caplets marked DL 90 or DL 120. 90mg-100, A21.53; 120mg-100, A35.60. P 120mg once or twice daily, increasing to 180mg twice daily if necessary. Q Not recommended. D Pregnancy. Sick sinus syndrome; 2nd or 3rd degree AV block; marked bradycardia, decompensated cardiac failure. B Observe patients with mild bradycardia or a prolonged PR interval. Measure heart rate regularly in the elderly and in patients with hepatic or renal impairment. C b -blockers, digitalis. A Bradycardia, 1st degree AV block, ankle oedema, nausea, headache, rash.
GSK
2NO
Prostaglandin. Epoprostenol 0.5mg, 1.5mg (as Na+ salt). Powder and solvent for soln for inf. 0.5mg, A122.96; 1.5mg, A198.88. S Long-term IV treatment of primary and secondary pulmonary hypertension in the scleroderma spectrum of diseases due to intrinsic precapillary pulmonary vascular disease in NYHA functional Class III and Class IV patients. P Short-term dose-ranging, initiate at 2ng/ kg/min and increase by increments of 2ng/kg/min every 15 mins or longer until max. haemodynamic benefit or dose-limiting effects. Long-term continuous inf., initiate at 4ng/kg/min less than max. tolerated inf. rate (MTiR) determined during short-term dose ranging. If MTiR Q 5ng/kg/min, start long-term inf. at one-half MTiR. Decrease gradually in 2ng/kg/min decrements every 15 mins EUCARDIC Roche or longer until dose-limiting effects resolve. Avoid 3MO abrupt withdrawal. Infusion rate: See SPC. R Caution. a/b-blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, Q Limited data. 25mg. Resp. pink, yellow, light brown or pale D CHF arising from severe LV dysfunction. beige round scored tab. marked BM on one side Do not use chronically in patients who develop and K1, F1, H3 or D5 on other side. 3.125mg-28, A3.67; 6.25mg-28, 4.36; 12.5mg-28, A4.78; 25mgpulmonary oedema during dose-ranging. B Monitor BP and heart rate during 28, A5.72. admin. Pregnancy and lactation (only if essential). S Hypertension. P Initially, 12.5mg once daily for two days C Caution: Anticoagulants, other vasodilators, NSAIDs. then 25mg once daily. If necessary titrate at two A Facial flushing, headache, GI disorders, week intervals to max. 50mg once daily or in jaw pain, dry mouth, lassitude, inf. site reaction, divided doses. chest pain, decreased platelet count, tachycardia, Q Under 18 years, not recomennded. bradycardia, anxiety, agitation. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV GOPTEN Abbott inotropic support, liver dysfunction. Contains lactose. 2MO ACE inhibitor. Trandolapril 0.5mg red/yellow cap. EXFORGE Novartis 1mg red/orange cap. 2mg red/red cap. 0.5mg-14, 2MO A1.83; 1mg-28, A4.49; 2mg-28, A5.30 . Ca++ antagonist/AII antagonist. Amlodipine (as S All grades of essential hypertension. amlodipine besylate) / valsartan 5mg/80mg, 5mg/ May be used alone or in combination with other 160mg, 10mg/160mg. Film-ctd tab, imprinted with antihypertensive drugs. NVR on one side. 5mg/80mg: Dark yellow, round P Initially 1mg daily as single dose, with bevelled edges, with NV on other side. 5mg/ adjusting according to response. Max. 4mg daily 160mg: Dark yellow, oval with ECE on other side. as single dose. If used with diuretic, discontinue 10mg/160mg: Light yellow, oval with UIC on other diuretic for 3 days before starting therapy with
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM 0.5mg daily, then titrate according to response. Renal or hepatic impairment, start therapy with 0.5mg then adjust according to response. Q Not recommended. D Pregnancy, women of child bearing potential, lactation, known hypersensitivity, angioneurotic oedema associated with ACE inhibitor. B Renal impairment, haemodialysis, neutropenia, hypotension. C K+suppl. or K+sparing diuretics, antidepressants, anaesthetics, lithium. A Hypotension, angioedema, rash, headache, dizziness, cough, palpitations, GI upset, malaise, nausea.
ACE inhibitor. Enalapril maleate 2.5mg, 5mg, 10mg, 20mg. 2.5mg: White, round, biconvex tabs. marked MSD 14; 5/10/20mg: White, rust-red and peach rounded triangle-shaped tabs. scored on one side and marked MSD 712, MSD 713 and MSD 714 resp. on the other. 2.5mg-28, A6.49; 5mg-28, A3.56; 10mg-28, A4.99; 20mg-28, A 5.93. S Hypertension. P Initially 5-10mg once daily. Usual maintenance dose, 20mg daily; max. 40mg daily. Q Not recommended; see SPC. D Angioedema. Pregnancy, lactation. B Reduce dose of diuretic, if possible, before initiating therapy. Volume depletion may cause symptomatic hypotension. LV valvular and outflow tract obstruction, renal impairment, renal HYPOVASE Pfizer artery stenosis, surgery. Angioneurotic oedema (discontinue promptly). Contains lactose. 2MO C Other anti-hypertensive agents, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. + K suppl., diuretics, antidiabetics, TCAs, NSAIDs, White tab. marked Pfizer and white tab. scored sympathomimetics, alcohol, gold. and marked M6, resp. B.D. Starter pack (8 x 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; A Cough, nausea, blurred vision, dizziness, hypotension, syncope, angina pectoris, 1mg-56, A4.07. tachycardia, headache, depression, dyspnoea, GI S Hypertension. disorders, taste alteration, rash, hypersensitivity/ P 500mcg on first evening, then 500mcg two or three times daily for 3-7 days, followed by angioneurotic oedema, asthenia, fatigue. 1mg two or three times daily for 3-7 days. INNOZIDE MSD Thereafter, increase gradually as required. Max. 5MO 20mg daily. Q Not recommended. ACE inhibitor/thiazide diuretic. Enalapril maleate D Sensitivity other quinazolines. 20mg, HCTZ 12.5mg. Yellow fluted scored tab. B Pregnancy, lactation. Initial low dose marked MSD 718 on reverse. 28, A16.72. and gradual titration is recommended. S Hypertension. C Other antihypertensives. Caution: PDE-5 P Usually 1 once daily. Max: 2 tabs. daily. inhibitors. Q Not recommended. A Depression, nervousness, dizziness, D Anuria, aortic/renal artery stenosis, drowsiness, headache, faintness, syncope, loss of hypertrophic cardiomyopathy, hyperkalaemia. conciousness, blurred vision, vertigo, palpitations, Hereditary or idiopathic angioedema, history of dyspnoea, nasal congestion, GI disorders, rash, angioneurotic oedema. Hypersensitivity to other urinary frequency, oedema, lack of energy, sulphonamide-derived drugs. Acute hypertension. weakness. CHF (no data). Moderate/severe renal impairment. Pregnancy, lactation. INDERAL LA AstraZeneca B Volume depletion may cause symptomatic hypotension. Haemodialysis, renal or 3MO hepatic impairment, surgery/anaesthesia, diabetes. Non-cardioselective b-blocker. Propranolol (HCl) Anaphylactoid reactions during LDL apheresis, 160mg. Lavender/pink hard prolong.-release cap. hypersensitivity/angioneurotic oedema reported marked INDERAL LA 28, A8.41. rarely. Contains lactose. 3MO C Lithium, antidiabetics, tubocurarine, ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. K+suppl. or K+sparing diuretics, allopurinol, Lavender/pink hard prolong.-release cap. marked cytostatic or immunosuppressive agents, A HALF-INDERAL LA. 28, 6.13. S Hypertension. Adjunct in thyrotoxicosis. procainamide, ganglionic or b-blockers, P Hypertension: 160mg daily increasing if cholestyramine, colestipol, NSAIDs, corticosteroids, ACTH, narcotic drugs/antispsychotics, alcohol, necessary in 80mg increments until adequate ciclosporin, antacids, sympathomimetics, pressor response is achieved. Thyrotoxicosis: 80mg or amines, gold. 160mg daily. Max. 240mg daily. A Dizziness, fatigue. Muscle cramps, Q Not recommended. nausea, asthenia, orthostatic effects including 3MO hypotension, headache, cough, impotence. ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, ISOPTIN Abbott A1.20. 2MO S As above and phaeochromocytoma. P Hypertension: initially 80mg twice daily Class I Ca++ antagonist. Verapamil (HCl) 40mg, increasing if necesary at weekly intervals to 16080mg, 120mg. White film-ctd. tabs. 40mg-100, 320mg daily. Phaeochromocytoma: 60mg daily A2.12; 80mg-100, A4.24; 120mg-100, A6.36. with a-blocker for 3 days preoperatively or 30mg 2NO daily in inoperable cases. ALSO ISOPTIN INJECTION Verapamil 5mg/2ml. Q 0.25-0.5mg/kg body weight three or Amp. 5 x 2ml, A6.44. four times daily. S Mild to moderate hypertension. D See 2.4, b-blockers Drug Presc. Notes. P 80-160mg three times daily. Tabs contain lactose. Q Up to 10mg/kg body weight daily in divided doses. INNOVACE MSD D Cardiogenic shock. 2nd or 3rd degree 2MO AV block. Severe bradycardia. Uncompensated
HYPERTENSION 2.4 cardiac failure. Sick sinus syndrome. B 1st degree AV block. Poor cardiac reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of myocardial infarction. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.
ISOPTIN SR
Abbott
2MO Class I Ca++ antagonist. Verapamil 240mg. Light green oblong film-ctd sust.-release tab. 28, A12.67. S Mild to moderate hypertension. P 1 daily. R v in the morning increasing by v at weekly intervals according to response. Q Not recommended. D See Isoptin.
ISTIN
Pfizer
2MO Ca++ antagonist. Amlodipine besylate 5mg, 10mg. White emerald-shaped tabs. marked AML-5 or AML-10 resp. and Pfizer on reverse. 5mg-28, A5.53; 10mg-28, A8.26. S Hypertension. P Initially 5mg daily, increasing to max. 10mg. Q Not recommended. B Impaired liver function. Pregnancy, lactation. A Oedema, headache, flushing, dizziness, nausea, palpitations, fatigue, abdominal pain, somnolence.
ISTOLDE
Actavis
2MO Ca++ antagonist. Amlodipine 5mg, 10mg. White, uncoated, round, flat, tab. with score on one side, embossed with AB5 or AB10 on the other. 5mg28, A8.54; 10mg-28, A12.71. S Essential hypertension. P Initially 5mg once daily. If no effect within 2-4 weeks, may be increased to max. 10mg once daily. R Caution when increasing dose. Q Under 18 years, not recommended. D Severe hypotension. Shock (incl. cardiogenic). Heart failure after acute MI (first 28 days). High-grade aortic stenosis. Unstable angina pectoris. Pregnancy, lactation. B Caution: Cardiac failure, hypertensive crisis (safety and efficacy not established), dialysis, hepatic impairment, heart failure (increased incidence of pulmonary oedema in NYHA class III and IV). C Caution: CYP3A4 inhibitors/ inducers, other antihypertensives. A Headache, somnolence, dizziness, weakness, palpitations, GI disorders, ankle oedema, facial flushing with heat sensation.
KAMIREN
Niche
2MO Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. 28, A12.27. S Hypertension. As monotherapy or in combination with thiazide diuretics, badrenoceptor blocking agents, Ca++ antagonists or ACE inhibitors. P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
55
2.4 HYPERTENSION
CIRCULATORY SYSTEM
once daily. Q Under 12 years, not recommended. D History of GI or oesophageal obstruction, or any degree of decreased lumen diameter of the GI tract. Pregnancy (only if benefit outweighs risk), lactation. B Caution: Impaired hepatic function. Introduction and adjustment. Initial dose: Excessive hypotensive effect may occur. Driving or operating machinery. Contains lactose. C Caution: PDE-5 inhibitors. A Palpitation, tachycardia, vertigo, GI disorders, asthenia, chest pain, peripheral oedema, back pain, myalgia, dizziness, headache, coughing, bronchitis, pruritus, urinary incontinence, cystitis, postural hypotension.
R Caution. Q Under 18 years, not recommended. D LV outflow tract obstruction. Untreated CHF. Unstable angina pectoris. Within 1 month of MI. Severe renal/hepatic impairment. Women of child-bearing potential (unless effective contraception used). Pregnancy, lactation. B Caution: Sick-sinus syndrome, angina pectoris, mild to moderate renal/hepatic dysfunction. Isolated cases of MI cases observed. Contains lactose. C Contra: Strong CYP3A4 inhibitors, ciclosporin, grapefruit juice. Caution: CYP3A4 inducers, CYP3A4 substrates (digoxin, cimetidine, terfenadine, astemizole, class III antiarrhythmic drugs), b-blockers. Avoid alcohol.
2MO
ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. Round tabs, can be divided in equal halves. 2.5mg: White, biconvex. 5mg: White, flat, scored both sides. 10mg: Light pink, biconvex, scored one side. 20mg: Pink, biconvex, scored one side. 2.5mg-28, A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, A10.16. S Hypertension. P Initially, 10mg. Patients with highly activated reninangiotensin-aldosterone system: 2.5-5mg initially. Maintenance, 20mg (single dose); if desired therapeutic effect not obtained within 2-4 weeks, may be increased to 80mg/day max. Patients on diuretics: If possible, withdraw diuretic 2-3 days before starting treatment; if not possible, start with 5mg/day, monitor serum K+ and renal LERCARIL Recordati KONVERGE A. Menarini / Daiichi Sankyo function. Renal impairment, ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, initially 2.5-5mg; 2MO 2MO ++ ++ 31QccQ80ml/min, initially 5-10mg/day. ACE inhibitor/Ca antagonist. Enalapril maleate/ Angiotensin II antagonist/ Ca antagonist. Q Not recommended. lercanidipine hydochoride 10mg/10mg, 20mg/ Olmesartan medoxomil / amlodipine (as besilate), D History of angioedema associated with 10mg. Resp. white and yellow biconvex, round 20mg/5mg, 40mg/5mg, 40mg/10mg. Round, filmcoated tablets. Resp. white, cream or brownish-red film-ctd tabs. 10mg/10mg-28, A16.08; 20mg/10mg- previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. A debossed with C73, C75 or C77 on one side. 20mg/ 28, 18.30. B Caution: Acute MI (do not use: Renal S Essential hypertension not adequately 5mg-28, A20.20; 40mg/5mg-28, A24.42; 40mg/ dysfunction, systolic BP R100mmHg, cardiogenic controlled by lercanidipine 10mg alone. Not for 10mg-28, A25.73. shock), mitral stenosis and left ventricle outflow initial treatment of hypertension. S Essential hypertension if BP not P Individual dose titration recommended. obstruction (aortal stenosis, hypertrophic adequately controlled on olmesartan medoxomil myocardiopathy), bilateral renal artery stenosis or Direct switch from monotherapy may be or amlodipine monotherapy. stenosis of the artery in a single kidney (strict P 1 tab. per day. Use 20mg/5mg tab. if BP considered. 1 tab. once a day at least 15 min supervision with low doses; careful dose before meals, preferably in the morning. not adequately controlled by 20mg olmesartan adjustment), pre-existing renal impairment R Adjust dose based on renal function. medoxomil or 5mg amlodipine alone. Use 40mg/ (monitor blood K+, creatinine), major surgery, Q Under 18 years, not recommended. 5mg tab. if 20mg/5mg tab. not adequately anaesthesia, renal insufficiency, diabetes. May D LV outflow obstruction, incl. aortic controlling BP; if BP still not adequately stenosis. Untreated CHF. Unstable angina pectoris. occur: Systemic hypotension, angioedema controlled, use 40mg/10mg tablets. Titration of (withdraw immediately if occurs), anaphylactoid Within 1 month of MI. Severe renal impairment, individual components recommended before reactions in haemodialysis patients or during incl. patients undergoing haemodialysis. Severe switching to fixed combination. R Monitor BP closely if max. daily dose of hepatic impairment. History of angioedema caused desensitisation treatment, acute renal insufficiency by previous therapy with ACE-inhibitor. Hereditary in patients with HF (usually reversible), hepatic 40mg olmesartan medoxomil required. insufficiency, neutropenia/agranulocytosis, cough. or idiopathic angioedema. Pregnancy, lactation. Q Under 18 years, not recommended. C Not recommended: Lithium. Caution: B Adjust diuretic dose in HF patients as D Severe hepatic insufficiency, biliary Diuretics, K+-sparing diuretics, K+ containing symptomatic hypotension may occur. Caution: obstruction. Cardiogenic shock. Acute MI (within supplements and salts, NSAIDs (incl. acetylsalicylic Sick-sinus syndrome, left ventricular dysfunction, first 4 weeks). Unstable angina pectoris. acid r 3g/day), other antihypertensives, injectable ischaemic heart disease, mild to moderate renal Pregnancy, lactation. impairment, bilateral renal artery stenosis or single gold, certain anaesthetic drugs, TCAs, B Correct volume and/or Na+ depletion antipsychotic agents, sympathicomimetics, antiartery stenosis, hepatic dysfunction, diabetes, before treatment. Not recommended: primary diabetics. surgery/anaesthesia. Not recommended after aldosteronism. Caution: Severe CHF, underlying A Dizziness, headache, cough, diarrhoea, recent renal transplantation. May occur: renal disease incl. renal artery stenosis, impaired vomiting, renal dysfunction, orthostatic effects Neutropenia/agranulocytosis, thrombocytopenia renal function, moderate hepatic impairment, (incl. hypotension). and anaemia, hypersensitivity/angioneurotic aortic or mitral valve stenosis, obstructive oedema, anaphylactoid reactions during LDLhypertrophic cardiomyopathy. May occur: LISOPRESS Niche apheresis with dextran sulphate, hyperkalaemia. Hyperkalaemia, pulmonary oedema (NYHA III and C Contra: Strong CYP3A4 inhibitors, 2MO IV heart failure patients), MI, stroke. No data: cyclosporine, grapefruit juice. Not recommended: ACE inhibitor. Lisinopril 2.5mg, 5mg white scored Recent kidney transplant, end-stage renal K+-sparing diuretics, K+ supplements, lithium, tabs. marked 2.5 or 5; 10mg white square tab. impairment. estramustine, CYP3A4 substrates, digoxin. Caution: scored one side and marked 10; 20mg white C Not recommended: K+ supplements, Antidiabetics, thiazides, loop diuretics, NSAIDs, pentagonal tab scored and marked 20. 2.5mg-28, salts containing K+, K+ sparing diuretics, heparin, baclofen, amifostine, TCAs, neuroleptics, A4.63; 5mg-28, A7.11; 10mg-28, A8.77; 20mg-28, ACE inhibitors, lithium. Caution: Other anaesthetics, narcotics, corticosteroids, A9.59. antihypertensives, NSAIDs, CYP3A4 inhibitors/ tetracosactide, other antihypertensives, allopurinol, S Arterial hypertension. inducers. cytostatic or immunosuppressive agents, systemic P Initially 5mg in the morning increasing A Dizziness, headache, oedema, fatigue. corticosteroids or procainamide, antacids, to maintenance 10-20mg daily. A lower dose symphthomimetics, acetylsalicylic, injectable gold, 2.5mg in the morning in renal dysfunction, HF, LECALPIN Actavis midazolam, cimetidine, simvastatin. Avoid alcohol. patients who do not tolerate discontinuation of 2MO A Dizziness, vertigo, cough, diuretics, volume and/or salt depletion, severe or hypersensitivity, angioedema, depression, Ca++ antagonist. Lercanidipine (HCl), 10mg, 20mg. renovascular hypertension, elderly. dizziness, headache, blurred vision, myocardial Resp. yellow or pink, round, biconvex, film-ctd Q Not recommended. infarction, arrhythmia, angina pectoris, tab., scored on one side, marked L on the other. D Pregnancy, lactation. Renal artery tachycardia, hypotension, syncope, cerebrovascular stenosis, severe renal impairment, 10mg-28, A8.22; 20mg-28, A13.42. accident, cough, dyspnoea, nausea, diarrhoea, S Mild to moderate essential haemodynamically relevant aortic or mitral valve abdominal pain, dysgeusia, rash, asthenia, fatigue, stenosis, haemodynamically unstable patients after hypertension. P 10mg once a day at least 15 min before chest pain, increased blood K+, increased blood acute MI. creatinine. meals; may be increased to 20mg depending on B Haemodialysis. Hypotension, unstable response. Titrate gradually. Renal/hepatic cardiac failure, renal impairment, renovascular LESTACE Actavis hypertension, primary hyperaldosteronism, insufficiency: Caution when increasing to 20mg.
56
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HYPERTENSION 2.4
proteinuria, angioneurotic oedema, aortic stenosis, surgery/anaesthesia. C K+ sparing diuretics, K+ suppl., diuretics, Na+, Cl, antihypertensive agents, analgesics, antiinflammatory agents, lithium, alcohol, anaesthetics, hypnotics, narcotics, sympathomimetics, antacids. A Hypotension, dizziness, weakness, impaired vision, syncope, tachycardia, palpitations, arrhythmias, chest pain, angina.
LISPRIL
Rowex
2MO ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, 20mg. Slightly red scored tabs. 5mg-30, A8.13; 10mg-30, A10.03; 20mg-30, A11.51. S All grades of essential and renovascular hypertension. P Initially 5mg in the morning, maintenance 10-20mg once daily. R Initially 2.5mg increasing to 5-10mg daily. Q Not recommended. D History of angioneurotic oedema related to previous ACE-inhibitor treatment. Pregnancy, lactation. B Renal impairment, hypotension (1st dose), aortic stenosis, acute MI, multiple or high dose diuretic therapy. C K+ suppl., antihypertensive agents, sympathomimetics, lithium, antacids, NSAIDs, alcohol, anaesthetics, narcotics, hypnotics, oral hypoglycaemic agents, diuretics, NaCl. A Hypotension, dry cough, sore throat, bronchitis, dizziness, feeling weak, impaired vision, nausea, stomach pain, indigestion, rash, headache, tiredness, palpitations, renal failure.
LISPRILHYDROCHLOROTHIAZIDE
Rowex
5MO ACE inhibitor/thiazide diuretic. Lisinopril and HCTZ 10mg/12.5mg, 20mg/12.5mg. Pink, round, biconvex tab. scored on one side. 10mg-30, A10.03; 20mg30, A11.52. S Essential hypertension where BP is not adequately controlled on lisinopril alone (or HCTZ alone). P Once daily, usually after titration with individual components. Max. 40mg/25mg. Q Not recommended. D Angioneurotic oedema relating to previous treatment with ACE inhibitor, hereditary/ idiopathic angioneurotic oedema. Severe liver and renal insufficiency (cc Q30ml/min). Stenosis of renal arteries. Pregnancy, lactation. B Electrolyte/fluid imbalance, ischaemic heart disease or cerebrovascular disease. Aortic stenosis, mitral stenosis or hypertrophic cardiomyopathy. Renal insufficiency (cc 30-80ml/ min); require titration of individual components. Hepatic disease, surgery/anaesthesia. Risk of angioedema. C K+ sparing diuretics, K+ suppl. and salt substitutes. Lithium, antidiabetics, NSAIDs, allopurino, cyclosporin, lovastatin, probenecid, trimethoprim, cardiac glycosides, sotalol, corticosteroids, colestyramin, TCADs, torsades de pointes-inducing drugs. A Dizziness, headache, fatigue, dry and persistent cough, hypotension.
LOAVEL
in patients not adequately controlled with monotherapies (1) in elderly hypertensive patients (2) in diabetic hypertensive patients (3) Presentation. Two strengths: tablets containing enalapril maleate 10 mg/lercanidipine hydrochloride 10 mg and enalapril maleate 20 mg/lercanidipine hydrochloride 10 mg. Indications. Treatment of essential hypertension in patients whose blood pressure is not adequately controlled by single component. Not for use as initial treatment of hypertension. Dosage. If blood pressure is not controlled by lercanidipine 10 mg alone, titrate up to 20 mg alone or switch to fixed combination Lercaril 10 mg/10 mg. If blood pressure not controlled by enalapril 20 mg alone titrate up to higher dose of enalapril monotherapy or switch to Lercaril 20 mg/10 mg. Individual dose titration with components can be recommended. Recommended dose for both strengths: one tablet every morning 15 minutes before meal (avoid grapefruit). Not recommended for children. Contraindications. Hypersensitivity to enalapril, lercanidipine, ACE inhibitors, strong inhibitors of CYP3A4, dihyropyridine calcium channel blockers; 2nd/3rd trimester; left ventricular outflow obstruction, untreated congestive heart failure, unstable angina, within one month of myocardial infarction; severe renal/hepatic impairment; hereditary or idiopathic angioedema; hereditary problems with galactose intolerance. Precautions and Warnings. In symptomatic hypotension careful monitoring required. More likely with volume depletion and heart failure. In sick-sinus syndrome and left ventricular dysfunction and ischaemic heart disease particular caution recommended. In mild to moderate renal impairment routine monitoring of serum potassium and creatinine recommended. In renovascular hypertension there is a risk of hypotension or renal failure with ACE-inhibitor therapy. In hepatic dysfunction antihypertensive effects may be potentiated. Cholestatic jaundice and hepatic necrosis has been observed with ACE-inhibitor therapy. Anaphylactoid reactions in concomitant use with insect venom desensitisation and LDL-apheresis are rare. In diabetes close monitoring of blood sugar needed for the first month. Alcohol should be avoided. Interactions. Possible potentiation with other hypotensives. Combination with potassium sparing diuretics, potassium supplements and lithium not recommended. Antihypertensive effect may be altered by NSAIDs, baclofen, cyclosporin, amifostine, tricyclic antidepressants, neuroleptics, anaesthetics, narcotics, nitrates, antacids, sympathomimetics and corticosteroids. Pregnancy and lactation. Not recommended. Side effects. For Lercaril 10 mg/10 mg; common: dizziness, vertigo, cough. Uncommon: abdominal pain, nausea, headache, hypersensitivity, rash, palpitations, tachycardia, circulatory collapse, hypotension, dry throat, polyuria, pollakiuria, erectile dysfunction, fatigue, asthenia, lowered haemoglobin. For Lercaril 20 mg/10 mg; common: headache, dizziness, flushing, cough, peripheral oedema. Uncommon: angioedema, thrombocytopenia, hypertriglyceridaemia, anxiety, palpitations, hypotension, pharyngolaryngeal pain, abdominal pain, constipation, dyspepsia, nausea, tongue disorder, erythema, rash, arthralgia, nocturia, fatigue, asthenia, feeling hot, increased ALT and AST. Pack size. 28 tabs. Legal category. POM. MAH. Recordati Ireland Limited. Raheens East, Ringaskiddy Co. Cork, Ireland. MAN. PA1404/002/001- 002. Date of First Authorisation/Renewal of the Authorisation. Date of First Authorisation: 22nd August 2008.For full prescribing information please see summary of product characteristics. References 1. Hair P.I., Scott L.I., Perry C.M.: Fixed-dose combination lercanidipine/enalapril. Drugs, 2007; 67 (1): 95-106 2. Puig J.G., Calvo C., Luurila O. et al.: Lercanidipine, enalapril and their combination in the treatment of elderly hypertensive patients: placebocontrolled, randomized, crossover study with four ABPM. J Human Hypertens, 2007; 21 (12): 917-924 3. Agrawal R., Marx A., Haller H.: Efficacy and safety of lercanidipine versus hydrochlorothiazide as add-on to enalapril in diabetic populations with uncontrolled hypertension. J Hypertens, 2006; 24 (1): 185-192 RILER0901017
sanofi-aventis
2MO AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
57
2.4 HYPERTENSION
CIRCULATORY SYSTEM P 50mg once daily. If necessary, increase to 50mg twice daily (1 tablet in the morning, 1 in the evening) or 100mg once daily (in the morning). May be administered with other antihypertensive agents, especially diuretics. Patients with intravascular volume depletion: 25mg once daily initially. Hepatic impairment: Consider lower dose. R Over 75 years, consider initiating therapy with 25mg. Q Not recommended. D Pregnancy, lactation. Severe hepatic impairment. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc. Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Contains lactose. C Caution: Other antihypertensives, fluconazole, rifampicin, NSAIDs, lithium (monitor levels). Not recommended: Heparin, K+ sparing diuretics, K+ supplements or salts. A Hypertension: Dizziness, vertigo. Hypertensive patients with left ventricular hypertrophy: Dizziness, vertigo, asthenia/fatigue. Hypertension and type 2 diabetes with renal disease: Dizziness, hypotension, asthenia/fatigue, hypoglycaemia, hyperkalaemia.
hypercalcaemia. Severe hepatic impairment; cholestasis and biliary obstructive disorders. Refractory hyponatraemia. Symptomatic hyperuricaemia/gout. Severe renal impairment. Anuria. Pregnancy, lactation. B History of angiooedema (closely monitor). Monitor K+ and cc. Caution: Mildmoderate hepatic impairment, renal artery stenosis, coronary heart disease, cerebrovascular disease, heart failure, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy. Not recommended: Haemodialysis patients, primary aldosteronism. May occur: Impaired glucose tolerance, symptomatic hypotension, exacerbation or activation of SLE, gout, increased cholesterol and triglyceride levels, serum Ca++ elevation. Contains lactose. C Not recommended: K+ sparing diuretics, K+ supplements or salt substitutes containing K+. Caution: Rifampicin, fluconazole, lithium, NSAIDs, TCAs, antipsychotics, baclofene, amifostine, barbiturates, narcotics, alcohol, antidepressants, antidiabetics, other antihypertensives, colestyramine and colestipol resins, corticosteroids, ACTH, pressor amines, muscle relaxants, probenecid, sulfinpyrazone, allopurinol, anticholingergics, cytotoxics, salicylates, methyldopa, cyclosporine, digitalis glycosides, class Ia and class III antiarrythmics, some antipsychotics, bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, terfenadine, vincamine IV, calcium, carbamazepine, iodine contrast media, parenteral amphotericin B, Rowex stimulant laxatives. May interfere with parathyroid LONITEN Pharmacia LOTANOS function tests. 2MO 2MO A Insomnia, headache, dizziness, cough, Angiotensin II antagonist. Losartan K+ 50mg, Vasodilator. Minoxidil 5mg. White tab. marked upper respiratory infection, nasal congestion, with tab. strength one side, scored and marked U 100mg. White oblong tab. Resp. with 1 or 3 notches on each side and embossed with 3 or 5 on sinusitis, sinus disorder, GI disorders, muscle cramp, above and below score on reverse. 60, A15.11. back/leg/chest pain, myalgia, asthenia/fatigue, S Severe hypertension that is symptomatic one side. 50mg-28, A11.73; 100mg-28, A19.71. hyperkalaemia, mild reduction of haematocrit and S Hypertension. or associated with target organ damage. P Hypertension: 50mg once daily. Maximal haemoglobin, cephalagia. Hypertension not controlled adequately by a antihypertensive effect attained after 3-6 weeks. If combination of a diuretic and a sympathetic LOW CENTYL K LEO Pharma necessary, increase to 100mg once daily. May be suppressant. Hypertension not manageable with 5MO administered with other antihypertensive agents. max. therapeutic doses of a diuretic plus two Thiazide/K+suppl. Bendrofluazide 1.25mg, K+ Cl Patients with intravascular volume depletion: other antihypertensives. 573mg (7.7mmol K+). Yellow, sug-ctd, oval, 25mg once daily initially. Hepatic impairment: P Initially 5mg daily in single or divided modified release tab. 250, A17.62. Consider a lower dose. doses, increase at three day intervals, if necessary S Hypertension alone or in combination to 20mg daily and then to 40mg daily; usual max. D Pregnancy, lactation. B Volume depletion may cause with other antihypertensives. 50mg daily. P 1 daily. R Initially 2.5mg daily, then as per adults. symptomatic hypotension. Caution: Hepatic impairment (dose adjustment), renal impairment Q Not recommended. Q Initially 0.2mg/kg body weight daily in (hyperkalaemia risk). May occur: Angioedema, D Precoma associated with hepatic single or divided doses increase, at three day cirrhosis, Addisonâ&#x20AC;&#x2122;s disease. Severe renal intervals, by 0.1-0.2mg/kg body weight daily. Max. changes in renal function. No data on use in haemodynamically significant obstructive valvular impairment. Hyperkalaemia. 1mg/kg body weight daily. disease. Contains lactose. B Diabetes, renal impairment, obstruction D Phaeochromocytoma. Lactation. C Caution: Rifampicin, fluconazole, K+ of urinary tract; caution. Obstruction of small B MI. Diuretics and sympathetic sparing diuretics, K+ supplements or salt bowel, ulceration (discontinue if occurs). suppressants must be given concurrently. Renal + substitutes containing K , indomethacin. Pregnancy, lactation (only if essential). impairment. Multiple reports of pericarditis. A Dizziness. Patients with left ventricular C K+ sparing diuretics, lithium. Caution: Pericardial effusion and tamponade have been Cardiac glycosides, antihypertensives. reported. Thrombocytopenia and leukopenia have hypertrophy: Dizziness, vertigo, asthenia/fatigue. A Rash, photosensitivity, myopia been rarely reported. Pregnancy. LOTANOS COMP Rowex aggravation, blood dyscrasias, gout, fatigue. Acute C Sympathetic-blocking agents e.g. pancreatitis, hyperuricaemia, GI upset, oliguria, guanethidine or bethanidine may produce 5MO dizziness, headache, muscle pain, thirst, dry excessive blood pressure reduction and/or Angiotensin II antagonist/thiazide. Losartan K+/ mouth. Vasculitis. orthostasis. HCTZ 50/12.5mg, 100/25mg. Light yellow, round, A Hypertrichosis, oedema, tachycardia. biconvex film-ctd tab. 50/12.5mg-28, A12.46; 100/ METOCOR Rowex 25mg-28, A23.83. LOSARTAN TEVA Teva 3MO S Essential hypertension when BP not 2MO adequately controlled on losartan or HCTZ alone. Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mgAngiotensin II antagonist. Losartan (K+) 50mg, P Start with 50mg/12.5mg once daily. If 100, A3.50; 100mg-100, A6.50. 100mg. White, oval, slightly arched film-ctd tabs, no response use 100mg/12.5mg or 100mg/25mg debossed with strength on one side, scoreline on S Hypertension. Adjunct in thyrotoxicosis. once daily (max. dose). the other. 50mg-28, A12.45; 100mg-28, A20.94. P Hypertension: initially 100mg daily Q Not recommended. increasing to 400mg daily in single or divided S Essential hypertension. D Therapy resistant hypokalaemia or
ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.57; 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. S All grades of hypertension. P Patients not on diuretics: Initially 2.5mg once daily, increasing incrementally at intervals of 1-2 weeks to 5mg. Max. 10mg once daily. R Consider initial dose of 1.25mg daily. Titrate according to need for BP control. Q Not recommended. D History of angiooedema. Aortic stenosis or outflow obstruction. Renal artery stenosis, hypotensive or haemodynamically unstable states. Pregnancy, lactation. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: Reduce dose and assess renal function prior to and during treatment. Caution: Patients with hyper stimulated angiotension system. Electrolyte monitoring recommended. Haemodialysis (avoid in patients dialysed with high flux membranes). Malignant hypertension: Initiate in hospital under close supervision. Symotomatic hypotension, agranulocytosis/bone marrow depression, hyperkalaemia have been reported rarely. Caution: Surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, sympathomimetics, antidiabetic agents, NSAIDs. A Nausea, dizziness, headache, dry tickling cough.
58
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5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM diabetes, history of hypersensitivity or bronchial asthma. Correct volume/ Na+ depletion before starting therapy. Monitor serum electolytes. May occur: Raised cholesterol and triglyceride levels, METOP Gerard hyperuricaemia or frank gout, exacerbation or activation of SLE, photosensitivity reactions 3MO (discontinue, protect from the sun / artificial UVA) Cardioselective b-blocker. Metoprolol tartrate Less effective in black patients. Contains lactose, 50mg, 100mg. White tabs. Both marked ml and A strength one side, G on reverse. 50mg-100, 3.50; sorbitol. C Drugs affecting serum K+ levels, digitalis 100mg-100, A6.51. S Hypertension. Adjunct in thyrotoxicosis. glycosides, drugs inducing torsades de pointes, antiarrhythmics, other antihypertensives, lithium, P Initially 100mg daily increasing to Ca++ salts, antidiabetics, b-blockers, diazoxide, 400mg daily in single or divided doses. drugs for treatment of gout (allopurinol, Thyrotoxicosis: 50mg four times daily. probenecid, sulfinpyrazone), anticholinergics, Q Not recommended. pressor amines, amantadine, anionic exchange D See 2.4, b-blockers Drug Presc. Notes. resins, cytotoxics, NSAIDs, curare derivatives, MICARDIS Boehringer Ing. cyclosporin, tetracyclines, alcohol, anaesthetics, sedatives, methyldopa, barbiturates, narcotics, 2MO antidepressants. Angiotensin II antagonist. Telmisartan 20mg, A Dizziness. 40mg, 80mg. White tabs. marked 50H, 51H, 52H resp. on one side and company symbol on other. MYOSTIN Teva 20mg: Round. 40mg, 80mg: Oblong. 20mg-28, 2MO A19.16; 40mg-28, A19.16; 80mg-28, A23.14. Ca++ antagonist. Amlodipine 5mg, 10mg (as S Treatment of essential hypertension. amlodipine maleate). White, round, tab. scored on P Usually 40mg once daily. Range 2080mg once daily. Severe renal impairment: Initially one side. 5mg-28, A8.28; 10mg-28, A12.38. S Essential hypertension. 20mg daily. May be used with thiazide diuretic. P 5mg once daily. If no sufficient effect Q Not recommended. within 2-4 weeks, may be increased to max. 10mg D Biliary obstructive disorders, severe once daily. hepatic impairment. Pregnancy, lactation. Q Under 18 years, not recommended. B Mild moderate hepatic impairment, D Severe hypotension, shock, HF after renovascular hypertension, renal impairment, acute MI (during 1st 28 days), obstruction of kidney transplant, intravascular volume depletion (correct prior to admin.), RAA stimulation, primary outflow-tract of left ventricle, unstable angina pectoris. Lactation, pregnancy (unless clearly aldosteronism, aortic and mitral valve stenosis, necessary). obstructive cardiomyopathy. May cause B Low cardiac reserve, hepatic + hyperkalaemia (monitor serum K in at risk impairment, cardiac failure, elderly; caution. patients). Contains sorbitol. Apparently less Driving/using machines. effective in black patients than other racial C Caution: CYP3A4 inhibitors/inducers, groups, ischaemic cardiopathy or CVD. other antihypertensives incl. b-blockers. C Not recommended: K+ sparing diuretics A Ankle swelling, headache, dizziness, or K+ supplements, lithium. Caution: NSAIDs, fatigue, asthenia, palpitations, dyspnoea, diuretics, heparin, immunosuppressors, abdominal pain, nausea, dyspepsia, flushing. trimethoprim. Concomitant use to be taken into account: Other antihypertensives, baclofen, NAPAMIDE PR Niche amifostine alcohol, barbiturates, narcotics or antidepressants, systemic corticosteroids. 5MO Antihypertensive diuretic. Indapamide 1.5mg. MICARDISPLUS Boehringer Ing. White, round, film-ctd prolonged release tab. 30, A4.05. 5MO S Essential hypertension. Angiotensin II antagonist/thiazide diuretic. P 1 daily. Telmisartan/HCTZ 40mg/12.5mg, 80mg/12.5mg, D Severe renal failure. Hepatic 80mg/25mg. Resp. red and white, red and white, encephalopathy or severe liver impairment. yellow and white tabs. with company logo and Hypokalaemia. coded H4, H8 and H9. 40/12.5mg-28, A19.16; 80/ B Impaired liver function. Monitor plasma A A 12.5mg-28, 23.14; 80/25mg-28, 28.45. Na+ before treatment and regularly thereafter. S Treatment of essential hypertension Monitor plasma K+ particularly in at risk patients. where monotherapy proves inadequate. P 40/12.5mg, 80/12.5mg or 80/25mg daily. May cause decrease in urinary calcium excretion. Monitor blood glucose in diabetics. Monitor uric Q Not recommended. acid; risk of gout in hyperuricaemic patients. Renal D Cholestasis and biliary obstructive insufficiency. Pregnancy, lactation, avoid. disorders, severe hepatic or renal impairment, C Not recommended: Lithium. Caution: refractory hypokalaemia, hypercalcaemia. Torsades de pointes-inducing drugs, NSAIDs, ACE Hypersensitivity to sulphonamide derivatives. inhibitors, other agents causing hypokalaemia, Pregnancy, lactation. baclofen, digitalis preparations. Combinations to B Not recommended: Primary be taken into consideration: K+ sparing diuretics, aldosteronism. Caution: Hepatic impairment, metformin, iodinated contrast media, imipramineprogressive liver disease, mild to moderate renal like antidepressants, neuroleptics, Ca++ salts, impairment (monitor renal function), renal artery cyclosporin, tacrolimus, corticosteroids, stenosis (renovascular hypertension risk), renal tetracosactide. transplantation, RAA system stimulation (severe CHF, renal disease), aortic or mitral valve stenosis, NATRILIX SR Servier obstructive hypertrophic cardiomyopathy, doses. Thyrotoxicosis: 50mg four times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
HYPERTENSION 2.4 5MO Antihypertensive diuretic. Indapamide hemihydrate 1.5mg. White sust.-release coated tab. 30, A3.25. S Hypertension. P 1 daily. Q Not recommended. D Severe renal failure, hepatic encephalopathy or severe hepatic failure, hypokalaemia. B Pregnancy, lactation. Monitor K+ and uric acid serum levels. Monitor blood glucose in diabetics. C Lithium, agents causing hypokalaemia, baclofen. A Hypokalaemia, fatigue, orthostatic hypotension, allergic manifestations.
NEBILET
A. Menarini
3MO Vasodilating cardioselective b-blocker. Nebivolol (as HCl) 5mg. White cross scored tab. 28, A12.94. S Essential hypertension. P 5mg daily, preferably at same time of day. As monotherapy or with other antihypertensive agents. Renal insufficiency: Initially, 2.5mg daily; may be increased to 5mg. R Initially 2.5mg daily. May be increased to 5mg. q 75 years; caution. Q Children and adolescents, not recommended. D See 2.4, b-blockers Drug Presc. Notes. Liver insufficiency or liver function impairment.
NEBILET PLUS
A. Menarini
5MO Vasodilating cardioselective b-blocker/ Thiazide. Nebivolol/ HCTZ 5mg/12.5mg; 5mg/25mg. Resp. pink or violet, round, slightly biconvex film-ctd tab. embossed with strength on one side and a score line on the other. 5/12.5mg-28, A12.94; 5/ 25mg-28, A12.94. S Essential hypertension. Fixed dose combinations indicated in patients whose BP adequately controlled on nebivolol and HCTZ separately. P 1 tab. daily, preferably at same time of day. R Over 75 years, caution. Q Not recommended. D Hypersensitivity to sulphonamidederivatives. Liver insufficiency or liver function impairment. Anuria, severe renal insufficiency. Refractory hypokalaemia, hypercalcaemia, hyponatraemia, symptomatic hyperuricaemia. Pregnancy, lactation. See also: 2.4 b-blockers Drug Presc. Notes. B Caution: Renal impairment, diabetes mellitus. May occur: Increases in cholesterol and triglycerides, hyperuricaemia and/or gout, electrolyte imbalances, SLE exacerbation or activation , photosensitivity reactions, decreases in serum protein bound iodine levels. Contains lactose. See also: 2.4 b-blockers Drug Presc. Notes. C Not recommended: Lithium, products associated with K+ loss and hypokalaemia. Caution: NSAIDs, Ca++ salts, some antipsychotics, bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin, pentamidine, sparfloxacin, terfenadine, vincamine IV, non-depolarizing skeletal muscle relaxants (e.g. tubocurarine), metformin, other b-blockers, diazoxide, pressor amines, probenecid, sulfinpyrazone and allopurinol, amantadine, salicylates, cyclosporine,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
59
2.4 HYPERTENSION
CIRCULATORY SYSTEM
(monitor serum K+ and creatinine levels), aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, ischaemic heart or NIVADIL Astellas cerebrovascular disease, elderly. Hyperkalaemia may occur; monitor serum K+ in at risk patients. 2MO NIFED Rowex Class II Ca++ antagonist. Nilvadipine 8mg, 16mg. Not recommended: Severe renal impairment 2MO Caps. containing sust.-release pellets coded Nv8 or (ccQ20ml/min), recent kidney transplant, severe hepatic impairment, primary aldosteronism. ++ Nv16. 8mg-28, A11.40; 16mg-28, A16.18. Class II Ca antagonist. Nifedipine 10mg. Oblong Contains lactose. brown caps. 100, A7.01. S Hypertension. C Not recommended: K+ suppl., K+ sparing P Initially 8mg increasing to max. 16mg S Mild to moderate hypertension. diuretics, lithium. Caution: NSAIDs, angiotensin II daily if necessary. P 30-60mg daily in divided doses. antagonists, other antihypertensives. Q Not recommended. R 15mg in divided doses. A Dizziness, bronchitis, cough, pharyngitis, D Cardiovascular shock, aortic stenosis. Q Not recommended. rhinitis, GI disorders, arthritis, back pain, skeletal Severe renal insufficiency (cc Q 30ml/min.). 2MO pain, haematuria, UTI, chest pain, fatigue, flu-like ALSO NIFED RETARD Nifedipine 10mg, 20mg. Pink Pregnancy, lactation. symptoms, peripheral oedema, pain, increased B Hepatic impairment, severe HF. film-ctd modified release tabs. 10mg-60, A8.08; C H2 antagonists, tricyclic antidepressants, creatine phosphokinase, hypertriglyceridaemia, 20mg-100, A18.16. hyperuricaemia, liver enzyme elevations. P Initially 10mg twelve hourly, increasing cyclosporin, anticonvulsants. A Headache, flushes, oedema, dizziness, if necessary to 40mg twelve hourly. OMESAR PLUS A. Menarini fatigue, nausea, GI fullness. Q Not recommended. 5MO D Cardiogenic shock. unstable angina Tillomed Angiotensin II antagonist/thiazide diuretic. pectoris, advanced aortic stenosis, porphyria, acute NORTENOLOL Olmesartan medoxomil/HCTZ, 20mg/12.5mg, 20mg/ MI. Women of child-bearing potential. Pregnancy, 3 M O 25mg. Round film-ctd tab. 20mg/12.5mg, reddishlactation. Cardio-selective b-blocker. Atenolol 25mg, 50mg, yellow; 20mg/25mg, pinkish embossed with C22, B Caution: Severe hypotension, poor 100mg. White, white, orange unscored film-ctd C24 resp. 28, A17.83. cardiac reserve, diabetes, malignant hypertension, tabs. marked A25, A50, A100 resp. 25mg-30, S Essential hypertension in patients whose irreversible renal failure with hypovolaemia, risk of A2.70; 50mg-30, A4.10; 100mg-30, A5.98. blood pressure is not adequately controlled on hypotensive crisis (medical supervision). 20mg S Hypertension. Retard tab. contain lactose. P 100mg daily; some patients 50mg daily. olmesartan medoxomil alone. P Initially, 20mg/12.5mg once daily. If BP C Not recommended: Rifampicin, antiClinical effect seen after 1-2 weeks. Renal not adequately controlled 20mg/25mg once daily epileptics. Caution: Cimetidine, erythromycin, impairment: See SPC. (max. daily dose). Moderate hepatic impairment: nefazodone, azole antifungals, digoxin, diltiazem, Q Not recommended. cyclosporine, tacrolimus, vincristine, antidiabetics, Initially 10mg once daily, max 20mg once daily; D See 2.4, b-blockers Drug Presc. Notes. qinidine, cisapride. Avoid grapefruit juice. Monitor BP and renal function. A Headache, facial reddening, ODRIK Abbott Q Under 18 years, not recommended. palpitations, dizziness, leg oedema. D Severe renal impairment. Severe hepatic 2MO ACE inhibitor. Trandolapril 0.5mg, 1mg, 2mg. Red/ impairment, cholestasis and biliary obstructive NIFTEN AstraZeneca yellow, red/orange and red/red caps. marked with disorders. Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic 3MO cap. name, logo and strength. 0.5mg-28, A 3.66; hyperuricaemia. Pregnancy, lactation. ++ Cardioselective b-blocker/Class II Ca antagonist. 1mg-28, A4.49; 2mg-28, A5.30. B Caution: Intravascular volume depletion Atenolol 50mg, sust.-release nifedipine 20mg. S All grades of hypertension. (risk of symptomatic hypotension), bilateral renal Reddish brown cap. marked NIF-TEN. 28, A12.96. P Starting dose, 1mg once daily, adjust artery stenosis or stenosis of the artery to a single dosage incrementally at intervals of 2-4 weeks S Hypertension uncontrolled on functioning kidney, mild-moderate renal according to response to a max. of 4mg as a monotherapy. impairment (monitor serum K+, uric acid and single daily dose. P 1 daily, increasing to 1 twice daily if creatinine levels), hyperkalaemia, diabetes, aortic Q Not recommended. necessary. or mitral valve stenosis, obstructive hypertrophic D History of ACE induced angioneurotic R Max. 1 daily. cardiomyopathy, ischaemic heart or oedema. Pregnancy, lactation. Q Not recommended. cerebrovascular disease, mild-moderate hepatic B Renal or hepatic impairment. D Bradycardia, cardiogenic shock, impairment. Hypersensitivity reactions to hypotension, metabolic acidosis, severe peripheral Anaesthesia. Blood dyscrasias. hydrochlorothiazide may occur (more likely if arterial circulatory disturbances, 2nd or 3rd degree A Cough, headache, asthenia, dizziness. history of allergy or bronchial asthma). Nausea, hypotension. Allergic hypersensitivity heart block, sick sinus syndrome, untreated Exacerbation or activation of systemic lupus phaeochromocytoma, uncontrolled HF, pregnancy, reactions. Rarely angioneurotic oedema. erythematosus reported with thiazide diuretics. lactation, severe aortic stenosis, marked renal OMESAR A. Menarini Not recommended: Recent kidney transplant, impairment (ccQ 15 ml/min). primary aldosteronism. Monitor serum electrolytes 2MO B Controlled HF. Conduction defects or regularly. Contains lactose. poor cardiac reserve. Prinzmetalâ&#x20AC;&#x2122;s angina, 1st Angiotensin II antagonist. Olmesartan medoxomil C Not recommended: K+ suppl., K+ sparing degree heart block. May aggravate less severe 10mg, 20mg, 40mg. White film-ctd tabs. with C13, diuretics, lithium. Caution: Amifostine, alcohol, peripheral arterial circulatory disturbances. May C14, C15 resp. embossed on one side. 10mg-28, barbiturates, narcotics, antidepressants, NSAIDs, A14.74; 20mg-28, A17.70; 40mg-28, A22.29. modify tachycardia of hypoglycaemia. May mask other antihypertensives, baclofen, Ca++ salts, thyrotoxicosis. Will reduce heart rate. Do not S Essential hypertension. discontinue abruptly in ischaemic heart disease. P Optimal dose, 20mg once daily. Initially, cholestyramine/colestipol resins, digitalis glycosides, class Ia and III antiarrhythmics, some History of anaphylactic reaction to allergens. 10mg once daily. Max.: 40mg daily. Take at same Asthmatics, diabetes, clinically significant liver time each day. Effect present within 2 weeks and antipsychotics, non-depolarizing skeletal muscle relaxants, anticholinergics, antidiabetics, bdisease. Discontinue if ischaemic pain occurs. Use max. by about 8 weeks. Mild to moderate renal blockers, diazoxide, pressor amines, probenecid, impairment: Max 20mg once daily. Moderate in men in in vitro fertilisation. sulfinpyrazone, allopurinol, amantadine, cytotoxic hepatic impairment: Max 20mg once daily. C Contra: Ca++ channel blockers with agents, salicylates, methyldopa, cyclosporine, Q 18 years and under, not suitable negative inotropic effects (e.g. verapamil, tetracyclines. (limited experience). diltiazem), rifampicin. Grapefruit juice, not D Pregnancy, lactation. Biliary obstruction. A Dizziness, fatigue. See SPC. recommended. Caution: Other dihydropyridines, B Intravascular volume depletion (risk of digitalis glycosides, clonidine, class 1 Rowex symptomatic hypotension). Caution: bilateral renal PENDREX antiarrhythmics (e.g. disopyramide), amiodarone, artery stenosis or stenosis of the artery to a single 2 M O sympathomimetics, prostaglandin synthetasefunctioning kidney, impaired renal function inhibiting drugs, anaesthetics, cimetidine. ACE inhibitor. Perindopril tert-butylamine 2mg, iodine products (high doses), cytotoxic agents, barbiturates, narcotics, anionic exchange resins. See also: 2.4 b-blockers Drug Presc. Notes. A See SPC.
60
A Oedema, dizziness, headache, GI disturbance, purpura, impotence, fatigue.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM 4mg, 8mg. White, round, biconvex tablet debossed with 2, 4 or 8 on one side. 2mg-30, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. S Hypertension. P In monotherapy or in combination with other antihypertensives. Initially 4mg once daily in the morning, may be increased to 8mg/day after 1 month. Patients with a strongly activated reninangiotensin-aldosterone system: Initially 2mg/day under supervision. Discontinue diuretics 3 days beforehand; if not possible, commence with 2mg and monitor renal function and serum K+. Renal impairment: See SPC. R Initially 2mg, may be progressively increased to 4mg after 1 month then to 8mg depending on renal function. Q Not recommended. D History of angioedema associated with previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. B If unstable angina pectoris occurs in 1st month, reappraise benefit/risk before continuing treatment. Volume depletion, symptomatic HF may cause symptomatic hypotension. Caution: Mitral valve stenosis, aortic stenosis, hypertrophic cardiomyopathy, collagen vascular disease, immunosuppressant therapy, treatment with allopurinol or procainamide, diabetes. Renal impairment: Adjust dosage according to cc and response to treatment. Anaphylactoid reactions may occur during dialysis with high flux membrane or low-density lipoproteins apheresis with dextran sulphate. Discontinue if angioedema occurs. May occur: Hepatic syndrome, neutropenia/ agranulocytosis, thrombocytopenia, anaemia, persistent non-productive cough, elevation in serum K+. Discontinue 1 day prior to surgery. C Avoid: Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anaesthetics, sympathomimetics, antacids. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia.
HYPERTENSION 2.4 electrolyte disturbance, mitral valve stenosis, obstruction in the outflow of the left ventricle, collagen vascular disease, anaesthesia (discontinue one day prior to surgery), patients at risk of hyperkalemia. May occur: Unstable angina pectoris (re-evaluate), jaundice, angioedema (promptly discontinue), anaphylactoid reactions (interrupt during LDL aphaeresis or desensitisation). Contains lactose. C Not recommended: Lithium, K+-sparing diuretics, K+ suppl, diuretics. Caution: Immunosuppressant, allopurinol or procainamide, oral antidiabetics, NSAIDs, vasodilators, certain anaesthetics, TCAs, antipsychotics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.
calcium antagonists (allow several days following discontinuation before administering b-blocker). Caution: Myocardial depressants, anti-arrhythmic agents, a or b-adrenoceptor stimulants, MAOIs, TCAs, general anaesthetics, clonidine (do not discontinue until several days after Prestim withdrawal). Adrenergic neuron blocking agents (e.g. guanethidine, reserpine), diuretics and other antihypertensives (incl. vasodilators). A GI disturbances, bradycardia, hypotension, cold extremities. May occur in susceptible individuals: Bronchospasm, sleep disturbances, depression. Hyperuricaemia, skin rashes.
PRETERAX ARGININE
Servier
5MO
ACE inhibitor/antihypertensive diuretic. Perindopril arginine 2.5mg, indapamide 0.625mg. White rodshaped scored tab. 30, A18.62. PLENDIL AstraZeneca S Essential hypertension. 2NO P 1 daily in the morning before a meal. Double dose if necessary. Class II Ca++ antagonist. Felodipine 2.5mg, 5mg, Q Not recommended. 10mg. Sust.-release film-ctd tabs. marked A/FM orA/FE. 2.5mg-28, A7.34; 5mg-28, A9.49; 10mg-28, D Hereditary/idiopathic angioneurotic A12.76. oedema. Severe renal failure or impaired hepatic S All grades of hypertension. function, hypokalaemia. Pregnancy, lactation. P Initially 5mg once daily adjust if B Electrolyte imbalance, diabetes, gout, necessary. Maintenance 5-10mg once daily. Max. hypotension, cardiac or renal failure, 20mg daily. atherosclerosis, renal artery stenosis, elderly, Q Not recommended. immunosuppressed patients, hepatic impairment, D Pregnancy, lactation. haemodialysis. B Severe hepatic insufficiency, recent C Lithium, K+ -sparing diuretics, K+ salts, myocardial ischaemia. non antiarrhythmic drugs which cause torsade de C Cimetidine, phenytoin, carbamazepine, pointes, anaesthetics, cytostatic or phenobarbitone. immunosuppressive agents. A Ankle oedema, dizziness, fatigue, A Asthenia, dizziness, headache, mood headache, flushing, palpitations, rash, mild swings, sleep disturbances, cramps, hypotension, gingival enlargement. allergic reactions, skin rashes, GI disorders, anorexia, nausea, dry cough, dry mouth, risk of PRESTIM Meda dehydration in elderly and heart failure, altered blood test results. Rarely angioneurotic oedema, 5NO haematological disorders. b-blocker/thiazide. Timolol maleate, 10mg; bendroflumethiazide, 2.5mg. White, flat, petalClonmel shaped tab. with ICN on 1 side and 132 and score PRINDACE 2MO line on the other. 30, A4.89; 100, A4.89. ACE inhibitor. Perindopril tert-butylamine 4mg, S Hypertension. PERCARNIL Actavis P Initially 1 tab. daily. May be increased 8mg. 4mg-30, A7.24; 8mg-30, A11.56. S Hypertension. after 2 weeks to 2 tab. max. Recommended dose 2MO P Initially, 4mg once daily in the morning 1-2 tabs/day either as single dose in morning or ACE inhibitor. Perindopril (tert-butylamine salt) before food in monotherapy or in combination. 4mg, 8mg. White tabs, PP marked on one side and divided doses morning and evening. If BP control May be increased to 8mg once daily after one strength on reverse. 4mg oblong with a break-line not achieved on 2 tab/day, consider titrating month. Strongly activated RAA system: Initially timolol and bendroflumethiazide separately or on both sides; 8mg circular. 4mg-30, A9.92; 8mg2mg daily. Renal impairment, see SPC. adding another hypotensive. Hepatic failure: May 30, A16.29. R Initially 2mg daily; may be progressively require dose adjustment. S Hypertension. P As monotherapy or in combination with D Asthma/history of asthma, 2nd and 3rd increased to 4mg after one month then to 8mg if necessary depending on renal function. degree atrioventricular block, severe bradycardia, other anti-hypertensives. Initially 4mg once daily Q Under 18 years, not recommended. uncontrolled or digitalis/diuretic refractory HF, in the morning or 2mg daily in patients with D Angioedema. Pregnancy, lactation. cardiogenic shock, digitalis intoxication or strongly activated renin-angiotensin-aldosterone B Increased risk of symptomatic hypokalaemia, precoma associated with hepatic, system or on diuretics (if possible discontinue 2-3 hypotension eg. salt depletion, hypovolaemia, days before). May be increased to 8mg once daily renal or Addisons’ disease. Pregnancy, lactation diuretics; correct, if possible, prior to therapy. (unless essential). after one month. Renal impairment: Based on cc Monitor BP, renal function, serum K+ closely, B Discontinue if marked bradycardia (see SPC). before and during treatment. Hyperkalemia, develops. Caution: Controlled CHF (discontinue if R 2mg daily, may be progressively increases in blood urea and plasma creatinine. increased to 4mg after one month then to 8mg if deteriorates), elderly, family history of asthma, Caution: Mitral valve stenosis, obstruction in the impaired hepatic or renal function, potential necessary depending on renal function (see SPC). Q Not recommended. outflow of left ventricle, diabetes. LDL apheresis. urinary tract obstruction, disorders rendering D Angioedema, history of ACEI related Jaundice, angioedema (facial/ intestinal) reported electrolyte balance precarious, uncontrolled or angioedema. Pregnancy, lactation. rarely; discontinue promptly. Discontinue one day brittle diabetes. May mask symptoms of B Symptomatic hypotension may occur. thyrotoxicosis and hypoglycaemia. Ocular changes prior to surgery. Contains lactose. Correct salt depletion / hypovolaemia, if possible, C Lithium, K+ supplements (not may occur (conjunctivitis, dry eye; consider prior to therapy. Monitor renal function and recommended), diuretics. Caution: NSAIDs, discontinuation). Monitor fluid and electrolytes. serum K+ before and during treatment. Caution: antihypertensives, vasodilators, antidiabetics, Withdraw gradually. Severe HF impaired renal function, tendency for C Contra: Lithium salts, verapamil or other anaesthetics, TCAs, antipsychotics, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
61
2.4 HYPERTENSION
CIRCULATORY SYSTEM
B Aortic stenosis or outlaw obstruction (not recommended). Renal impairment risk (dosage reduction and/or discontinue); assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, RAMIC surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell 2MO RAMITACE Clonmel count, haemoglobin content and platelet count, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Hard hyperkalaemia, hyperkalaemia (hypertensive caps. with light grey body and light green, green, 2 M O patients), angioneurotic oedema. Avoid and dark green cap marked R on cap and strength ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Cap.haemodialysis using high flux polyacrylonitrile on body. 2.5mg-28, A6.07; 5mg-28, A8.46; 10mg- shaped, flat tabs. scored on one side. 2.5mg: membranes and low-density lipoprotein apheresis Yellow marked R2. 5mg: Pink marked R3. 10mg: 28, A11.54. with dextran sulphate. White marked R4. 2.5mg-28, A5.80; 5mg-28, S Hypertension. C Caution: Antidiabetics, NSAIDs. A8.10; 10mg-28, A11.04. P Initially, 2.5mg once a day; should be A Nausea, dizziness, headache, increased at intervals of 1-2 weeks, up to max. S Essential hypertension. symptomatic hypotension, MI, cerebrovascular 10mg once a day. Consider combination treatment P Initially, 2.5mg once a day; usual dose accident, chest pain, palpitations, rhythm if 10mg not effective. Patients with CHF also: 2.5-5mg/day; maximum 10mg once a day. Dose disturbances, angina pectoris, impaired renal 1.25mg initially under close supervision. Diuretic adjustments should occur after 2-3 weeks of function, GI disorders, hypersensitivity reactions, treated patients: Discontinue diuretic 2-3 days treatment. Consider combination treatment if prior to therapy. If diuretic cannot be 10mg not effective. Hypertension with HF: Initially cutaneous and mucosal reactions, vasculitis, muscle and joint pains, fever or eosinophilia, dry tickling discontinued, start with 1.25mg. Renal impairment: 1.25mg once daily. On diuretics: Discontinue See SPC. diuretic 2-3 days before therapy (or earlier if long- cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss Q Not recommended (contra). acting). If diuretic cannot be discontinued, initial of appetite, depressed mood, feeling of anxiety, D History of angioneurotic oedema dose 1.25mg. Renal impairment: cc Q50ml/min, paraesthesiae, taste change/reduction/loss, muscle relating to previous ACE inhibitor treatment. initially 1.25mg once daily; max. 5mg once daily; cramps, erectile impotence, reduced sexual desire, Pregnancy, lactation. cc Q20ml/min, initially 1.25mg every second day; increased blood urea nitrogen and serum B Aortic stenosis, outflow obstruction (not max. 2.5mg once daily. creatinine, deterioration of pre-existing recommended). Hypotension, agranulocytosis, Q Not recommended. proteinuria. bone marrow depression, hyperkalaemia, D Hypersensitivity to any ACE inhibitors. angioneurotic oedema may occur. Assess renal Angioneurotic oedema. Renal artery stenosis, RASILEZ Novartis function prior to and during treatment. Impaired kidney transplantation. Renal dysfunction or 2MO liver function (reduce dose), collagen vascular hypotension in patients with acute MI. Primary Renin inhibitor. Aliskiren (as hemifumarate) disease; monitor. Correct volume/salt depletion hyperaldosteronism. Pregnancy, lactation. 150mg, 300mg. Biconvex film-ctd tabs. marked before initiating therapy. Surgery/ anaesthesia. B Mitral valve stenosis or outflow NVR on one side. 150mg: Light-pink, round Haemodialysis using high-flux membranes (avoid). obstruction (caution). Jaundice (discontinue). Driving/ operating machines. Haemodialysis using high-flux membranes (risk of marked IL on reverse. 300mg: Light-red, ovaloid marked IU on reverse. 150mg-28, A23.56; 300mgC Caution: Antidiabetics, NSAIDs. anaphylactoid reactions). Fluid/salt abnormalities, 28, A31.30. A Nausea, dizziness, headache, GI severe hypertension, elderly. If potential for disturbances, dry tickling cough, skin/mucosal symptomatic hypotension; monitor closely. S Essential hypertension. reactions, sinusitis, bronchitis, conjunctivitis, hair Surgery/anaesthesia. Bone marrow depression, P 150mg once daily with light meal, loss. hyperkalaemia, angioneurotic oedema have been preferably same time each day; may be increased reported. Contains lactose. Driving/using machines. to 300mg once daily. Effect substantially present RAMILO Rowex C Caution: K+ sparing diuretics, K+ within 2 weeks. Use alone or in combination with supplements, diuretics, nitrates, other vasodilators, other antihypertensives. 2MO heparin, alcohol, allopurinol, procainamide, Q Under 18 years, not recommended. ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, cytostatics or immunosuppressants, trimethoprim, D Concomitant use with ciclosporin and 10mg. White, oblong, biplane with facet tabs. antidiabetics, sympathomimetics, NSAIDs. Avoid other potent P-gp inhibitors (quinidine, marked R 1.25, R 2.5, R 5, and R 10 on one side. verapamil). Lactation (not recommended), Both sides with breaking notch. 1.25mg-30, A4.39; lithium. A Dizziness and headache, orthostatic pregnancy. 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, effects, diarrhoea, vomiting, cough, renal B Volume- and/or salt-depleted patients, A11.78. impairment. supervise closely. Caution in: Severe heart failure, S Hypertension. severe renal dysfunction, renal artery stenosis, P Initially 2.5mg once daily swallowed RAMYTE Actavis history of dialysis, nephrotic syndrome, or whole with plenty of liquid. May be increased at renovascular hypertension. Increased risk of intervals of 2-3 weeks to 5mg, then to max. 10mg 2 M O hyperkalaemia in patients treated with RAS ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 once daily, or to max. 5mg once daily if agents, reduced kidney function, diabetes mellitus. + hard cap. containing white powder, with light concomitant diuretic or Ca channel blocker is Persistent diarrhoea, discontinue. grey body and resp. light green, green or dark used. Concomitant diuretic treatment/ C Caution: Furosemide, drugs that may green cap, marked R on cap and strength on nephropathy: Initially 1.25mg once daily. Renal increase serum K+, digoxin, irbesartan, meals with body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, impairment: See SPC. Impaired hepatic function: high fat content, inducers of P-gp (St. Johnâ&#x20AC;&#x2122;s wort, A10.92. Max. 2.5mg daily. rifampicin), moderate P-gp inhibitors. Avoid S Hypertension. Q Not recommended. grapefruit juice. P Without diuretics and without CHF, D Angioedema, history of angioedema A Diarrhoea. initially 2.5mg once daily. Increase dose with previous ACE inhibitor therapy. Pregnancy, incrementally at intervals of 1-2 weeks up to max lactation. RASILEZ HCT Novartis 10mg once daily. Usual effective dose: 2.5-10mg. B If possible, discontinue diuretic Combination treatment recommended if response 5 M O treatment 2-3 days before therapy initiation. unsatisfactory at 10mg. Diuretic-treated patients, Renin inhibitor/Thiazide. Aliskiren (as Volume depletion may cause symptomatic discontinue diuretic 2-3 days before initiating. hemifumarate)/HCTZ, 150mg/12.5mg; 150mg/25mg; hypotension. Caution: LV valvular and outflow Renal/hepatic impairment, see SPC. 300mg/12.5mg; 300mg/25mg. Biconvex, ovaloid tract obstruction, renal impairment, renal artery R Caution. film-ctd tab. marked NVR on one side. 150mg/ stenosis, haemodialysis patients, surgery. D History of angioneurotic oedema 12.5mg: White, marked LCI on other side. 150mg/ Discontinue if jaundice occurs. Driving/ operating relating to previous ACE inhibitor treatment. 25mg: Pale yellow, marked CLL on other side. machines. Pregnancy, lactation. Use in children. 300mg/12.5mg: Violet white, marked CVI on other C Lithium (not recommended). Caution: Other anti-hypertensive agents, K+suppl. or K+sparing diuretics, diuretics, TCAs, anaesthetics, antipsychotics, antidiabetics, NSAIDs, sympathomimetics. A Dizziness, headache, cough, orthostatic effects (incl. hypotension), diarrhoea, vomiting, Pinewood renal dysfunction.
sympathomimetics, injectable gold. A Hypotension, headache, dizziness, vertigo, paraesthesia, vision disturbance, tinnitus, cough, dyspnoea, GI disorders, dysgeusia, dyspepsia, rash, pruritus, muscle cramps, asthenia.
62
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM side. 300mg/25mg: Light yellow marked CVV on other side. 150mg/12.5mg-28, A23.34; 150mg/ 25mg-28, A23.72; 300mg/12.5mg-28, A30.29; 300mg/25mg-28, A30.62. S Essential hypertension: In patients with BP not adequately controlled on aliskiren or HCTZ alone or as substitution therapy in patients adequately controlled with aliskiren and HCTZ, given concurrently, at same dose as combination. P 1 tab. daily with a light meal, preferably at same time. Max effect seen within 4 weeks. Adjust dose according to clinical response, up to max 300mg/25mg. Q Under 18 years, not recommended. D History of angioedema with aliskiren. Pregnancy, lactation. Severe renal impairment. Refractory hypokalaemia, hypercalcaemia. Severe hepatic impairment. B Correct volume- and/or salt-depletion before treatment. Caution: Serious CHF (NYHA class III-IV), impaired hepatic function, progressive liver disease, aortic or mitral stenosis, obstructive hypertrophic cardiomyopathy, renal artery stenosis, or stenosis to solitary kidney (discontinue if renal failure occurs). Discontinue if angioedema occurs. May occur: Electrolyte imbalance, hyperuricaemia, precipitation of frank gout, SLE exacerbation or activation. Increased risk of hypokalaemia: Liver cirrhosis, brisk diuresis, inadequate oral electrolyte intake, concomitant corticosteroids / adrenocorticotropic hormone. Increased risk of hyperkalaemia: Concomitant RAS agents, reduced kidney function, diabetes mellitus. Discontinue before carrying out tests for parathyroid function. Persistent diarrhoea, discontinue. Contains lactose, wheat starch. C Contra: Ciclosporin and other potent Pgp inhibitors (quinidine, verapamil). Caution: K+ sparing diuretics, K+ supplements and salts , other products that may increase serum K+ levels (e.g. heparin Na+), digitalis glycosides, antiarrhythmics, other antihypertensives, moderate P-gp inhibitors, furosemide, NSAIDs, meals with high fat content, lithium, alcohol, antidiabetics, anionic exchange resins, pressor amines, antigout medications, Ca+ supplements or Ca+-sparing products (e.g. vitamin D therapy), curare derivatives, b-blockers, diazoxide, anticholinergics, amantadine, cytotoxic products (e.g. cyclophosphamide, methotrexate). Avoid grapefruit juice. A Diarrhoea.
HYPERTENSION 2.4 one side and 200 or 400 on reverse. 200mg-28 (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), A15.11. S Mild to moderate hypertension. P 200mg once daily. In case of inadequate response, increase to 400mg once daily taken one hour before or two hours after meals. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy.
P 1 daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
TENORMIN
AstraZeneca
3MO
Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange biconvex film-ctd tabs. marked Tenormin 25, Tenormin 50, and Tenormin respectively. 100mg bisected on reverse. 25mg-28, A1.97; 50mg-28, A2.54; 100mg-28, SOPROL Helsinn Birex A3.23. 3MO S Cardiac arrhythmias. Early intervention in acute MI. Angina pectoris. Hypertension. Cardioselective b-blocker. Bisoprolol fumarate P 50-100mg daily. 5mg, 10mg. White film-ctd tabs. marked Q Not recommended. BISOPROLOL and tab. strength on one side. 5mgA A D See 2.4, b-blockers Drug Presc. Notes. 28, 3.45;10mg-28, 3.86. S Hypertension. TEVETEN Solvay P 5-20mg once daily, usually 10mg once daily. 2MO Q Not recommended. Angiotensin II antagonist. Eprosartan mesylate D See 2.4, b-blockers Drug Presc. Notes. 400mg pink oval film-ctd tab.; 600mg white cap.Acute HF or during episodes of HF shaped film-ctd tab. 400mg-56, A24.02; 600mg-28, decompensation requiring IV inotropic therapy. A18.01. C See 2.4, b-blockers Drug Presc. Notes. S Essential hypertension. Avoid: Floctafenine, sultopride. Caution: P Usual maintenance dose 600mg once Rifampicin, baclofen, iodated contrast products, daily. mefloquine, corticosteroids. Q Not recommended. D Severe hepatic impairment. Pregnancy, SOTACOR BMS lactation. 3MO B Severe renal impairment, patients Non-cardioselective b-blocker. Sotalol (HCl) 80mg, undergoing dialysis, moderate hepatic impairment, severe cardiac insufficiency or renal artery stenosis. 160mg. Both white tabs. scored on one side and Correct vol/salt depletion prior to therapy. Primary tab. strength marked on other side. 80mg-28, A1.60; 160mg-28, A3.16. hyperaldosteronism (avoid). Aortic and mitral valve stenosis, hypertrophic cardiomyopathy. S Prevention of myocardial infarction. Contain lactose. Cardiac arrhythmias. Angina. Hypertension. P Reinfarction: 320mg once daily, starting C Caution: K+sparing diuretics, K+suppl, 5-14 days after infarction. Arrhythmias: Initial dose lithium. 80mg either singly or as 2 divided doses. Allow 2-3 A Viral infection, hypertriglyceridaemia, days between increments. Most respond to dose headache, dizziness, fatigue, depression, pain (incl. of 160-320mg admin. in 2 divided doses at 12 hr chest / back), palpitation, rhinitis, pharyngitis, intervals. In renal impairment; cc q60ml/min: dyspnoea, upper RTIs, cough, arthralgia, UTIs, GI Normal dose; cc 30-60ml/min: Half normal dose; cc disorders, asthenia, injury. 10-30ml/min: Quarter normal dose; cc Q10ml/min: TEVETEN PLUS Solvay Avoid. Q Not recommended. 5MO D See 2.4, b-blockers Drug Presc. Notes. Angiotensin II antagonist/thiazide diuretic. Prolonged QT interval, torsades de pointes, renal Eprosartan (as mesylate) 600mg and HCTZ 12.5mg. failure. Butterscotch, capsule-shaped film-ctd tab. marked B Caution: Pre-existing arrhythmias, QT 5147 on one side and SOLVAY on reverse. 28, interval q 550msec. Electrolyte disturbances esp. RUSTIN Helsinn Birex hypokalaemia or hypomagnesaemia. Caution: Left A18.68. S Essential hypertension for patients 2MO ventricular dysfunction, recent MI. See b-blockers whose BP is not adequately controlled on Prescribing Notes. See 2.4, b-blockers Drug Presc. Ca++ antagonist. Amlodipine 5mg, 10mg (as eprosartan alone. amlodipine besilate). White, round, slightly arched Notes. P 1 once daily in the morning. tabs. marked with AB 5 or AB 10 resp. 10mg tab. TENORET 50 AstraZeneca Q Under 18 years, not recommended. is scored. 5mg-28, A4.40; 10mg-28, A6.58. D Severe hepatic impairment. Severe renal 5MO S Essential hypertension. impairment, therapy resistant hypokalaemia or P 5mg once daily, may be increased to Cardioselective b-blocker/thiazide diuretic. hypercalcaemia, biliary obstructive disorders, max. dose of 10mg daily depending on response. Atenolol 50mg, chlorthalidone 12.5mg. White symptomatic hyperuricaemia/gout. Pregnancy, Q Not recommended. film-ctd tab. marked TENORET 50 one side. 28, lactation. A2.77. D Lactation, pregnancy (unless clearly B Renal artery stenosis, severe cardiac necessary). S Hypertension, particularly in the elderly. insufficiency, aortic and mitral valve stenosis or B Heart failure, hepatic impairment. P 1 daily. obstructive hypertrophic cardiomyopathy, mild to A Somnolence, dizziness, headache, Q Not recommended. moderate hepatic insufficiency; caution. Monitor palpitations, flushing, abdominal pain, nausea, D See 2.4, b-blockers Drug Presc. Notes. serum electrolytes periodically. Impaired renal oedema, fatigue. function, diabetes mellitus; risk of increased serum TENORETIC AstraZeneca K+. Primary hyperaldosteronism; not SELECTOL sanofi-aventis 5 M O recommended. May exacerbate systemic lupus 3MO Cardioselective b -blocker/thiazide diuretic. erythematosus. Atenolol 100mg, chlorthalidone 25mg. White film- C Caution: K+-sparing diuretics, K+ suppl. Vasodilating cardioselective b-blocker. Celiprolol ctd tab. marked TENORETIC. 28, A3.92. (HCl) 200mg yellow heart-shaped tab.; 400mg or other drugs increasing K+ level (eg. heparin), white heart-shaped tab. Both marked with logo drugs affected by serum K+ disturbances (eg. S Mild to moderate hypertension. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
63
2.4 HYPERTENSION
CIRCULATORY SYSTEM
100mg. White tabs. 25mg: Circular, flat, scored on one side. 50mg and 100mg: Biconvex, film-ctd, marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mg30, A3.90; 100mg-30, A5.50. S Hypertension. P Usually, 50mg as a single daily dose. Effects fully established after 1-2 weeks. 100mg as single daily dose or combination with other agent may be required. Renal failure: Reduce dose (see SPC). Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. B Caution: Patients with poor cardiac reserve. Will reduce heart rate. Contains lactose (50mg and 100mg). See 2.4, b-blockers Drug Presc. TILDIEM LA Sanofi Notes. C See 2.4, b-blockers Drug Presc. Notes. 2MO A Precipitation of atrioventricular block, Class III Ca++ antagonist. Diltiazem (HCl) 200mg purpura, thrombocytopenia, impotence. See 2.4, bpink/grey cap.; 300mg white/yellow cap.; blockers Drug Presc. Notes. containing immediate release and sust.-release pellets. 200mg-28, A11.87; 300mg-28, A12.95. TRIALIX sanofi-aventis S Hypertension. P Initially 1 x 300mg once daily, increasing 5 M O if necessary to 2 x 200mg once daily, or then 1 x ACE inhibitor/loop diuretic. Ramipril 5mg, 200mg plus 1 x 300mg daily. piretanide 6mg. Yellow/white scored tab. marked R Initially 1 x 200mg daily increasing to 1 LC one side, ARD on reverse. 28, A15.87. x 300mg once daily. S Hypertension insufficiently controlled Q Not recommended. with monotherapy but stabilised on individual 2MO components given in same proportions. P 1 daily taken in the morning. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, Q Not recommended. 120mg. Off-white sust.-release tabs. 90mg-56, A13.66; 120mg-56, A15.19. D History of angioneurotic oedema, aortic stenosis, outflow obstruction. Precomatose states P 90-120mg twice daily. Max. 360mg associated with cirrhosis. Pregnancy, lactation. daily. R Initially 120mg daily adjusting to 90B CHF, hepatic impairment, blood 120mg twice daily as required. dyscrasias. Cerebrovascular disease, renal Q Not recommended. impairment; reduce dose and asses renal function D Pregnancy. Sick sinus syndrome; 2nd or prior and during treatment. Gout. Diabetes. 3rd degree AV block; marked bradycardia. Prostatic hypertrophy or impaired micturition. B Observe patients with mild bradycardia Haemodialysis (avoid in patients dialysed with or a prolonged PR interval. Measure heart rate high flux membranes). Ability to drive or operate regularly in the elderly and in patients with machinery may be impaired. hepatic or renal impairment. C Antihypertensive agents, K+sparing C b -blockers, digitalis. diuretics, K+suppl., lithium, antidiabetic agents, A Bradycardia, 1st degree AV block, ankle NSAIDs, digitalis, aminoglycosides, cephalosporins. oedema, nausea, headache, rash. A Electrolyte imbalance. Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, TRANDATE UCB diarrhoea, cough. Liver dysfunction. Rarely, 3MO symptomatic hypotension, angioneurotic oedema, syncope, renal impairment. Hypersensitivity a/b-blocker. Labetalol (HCl) 100mg, 200mg. Orange film-ctd tabs. marked with tab. name and reactions. strength. 100mg-50, A5.07; 56, A5.67; 250; sanofi-aventis A24.16; 200mg-50, A8.18; 56, A9.16; 250, A38.27. TRIAPIN S Hypertension, incl. hypertension of 2NO pregnancy and for long term management of Ca++ antagonist/ACE inhibitor. Felodipine/ramipril hypertension following acute myocardial 2.5mg/2.5mg, 5mg/5mg. Both circular, biconvex, infarction. Angina. prolonged release tabs. marked with strength. P Initially 100mg twice daily with food 2.5mg, apricot coloured, marked H above OD on increasing if necessary at fouteen day intervals. reverse; 5mg, reddish-brown, marked H above OE Max. 2.4g daily in three or four divided doses. on reverse. 2.5mg-28, A22.23; 5mg-28, A28.23. Q Not recommended. S Essential hypertension when BP not 3NO adequately controlled on felodipine or ramipril ALSO TRANDATE INJECTION Labetalol (HCl) 5mg/ alone. ml. Amp. 5 x 20ml, A16.41. P 1 tablet 2.5mg/2.5mg or 5mg/5mg once S Severe hypertension incl. severe daily without food or following light meal. Max. hypertension of pregnancy; as a hypertensive 5mg/5mg once daily. Swallow whole, do not agent in anaesthesia following acute myocardilal divide, crush or chew. infarction. Q Not recommended. B See 2.4, b-blockers Drug Presc. Notes. D History of angioneurotic oedema, Liver damage. Contains sodium benzoate. unstable haemodynamic conditions (cardiovascular shock, untreated HF, acute MI, unstable angina TRANTALOL Pinewood pectoris, stroke), AV block II or III. Severely 3MO impaired hepatic or renal renal function (ccQ20ml/ Cardioselective b-blocker. Atenolol 25mg, 50mg, min), dialysis. Pregnancy, lactation. antiarrhythmics), other antihypertensives, barbiturates, narcotics or alcohol, lithium. HCTZ: Kaliuretics, laxatives, corticosteroids and ACTH, cardiac glycosides, Ca++ suppl. or Ca++ sparing drugs, b-blockers and diazoxide, gout treatment, anticholinergics, sympathicomimetics, amantadine, anionic exchange resins, cytotoxic substances, NSAIDs, non-depolarizing skeletal muscle relaxants, tetracyclines. A CNS disorders (eg. dizziness, headache, sleeplessness, depression), bronchitis, abdominal pain, albuminuria, UTIs, arthrosis, back pain, increased serum transaminases, hyperkalaemia, hyperglycaemia, leucocytosis.
64
B Angio-oedema (discontinue if occurs). Monitor renal and liver function (discontinue if jaundice or marked elevations of hepatic enzymes occur). Activated renin-angiotensin system, mild to moderate renal impairment, renovascular hypertension/renal artery stenosis, recent kidney transplantation. Symptomatic hypotension, proteinuria, agranulocytosis and neutropenia may occur. Surgery/ anaesthesia, aortic stenosis/ hypertrophic cardiomyopathy, HF, coronary or cerebrovascular insufficiency. Dialysis or haemofiltration with certain high-flux membranes (avoid). Hyperkalaemia (monitor if used concomitantly with other drugs which increase serum potassium levels). Contains lactose. Driving/ operating machines. C Not recommended: Potent CYP3A4 inhibitors or inducers, K+-sparing diuretics, K+ salts. Caution: Antihypertensives, diuretics, nitrates, lithium, antipsychotics, narcotics, anaesthetics, allopurinol, immunosuppressants, corticosteroids, procainamide, alcohol, cytostatics, NSAIDs, vasopressor sympathomimetics, antidiabetics, theophylline, tacrolimus, heparin, salt. A Headache, flush, peripheral oedema, dry tickling cough.
TRITACE
sanofi-aventis
2MO ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.59; 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. S All grades of hypertension. P The initial dose in patients not on diuretics is 2.5mg once daily, increasing to 5mg with max. 10mg once daily increasing at intervals of 1-2 weeks. R No special dosage recommendations for elderly patients apart from general warning about patients with renal or hepatic insufficiency or CHF which may be common in elderly and concomitant use of diuretic drugs. Dose titrated according to need for BP control. Q Not recommended. D History of angioneurotic oedema. Aortic stenosis, outflow obstruction. Pregnancy, lactation. Hypersensitivity to ramipril. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: reduce dose and assess renal function prior to and during treatment. Haemodialysis (avoid in patients dialysed with high flux membranes). Use with caution in surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, NSAIDs. A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.
VASCACE
Roche
2MO ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. White, yellow, red or brown oval film-ctd scored tabs. marked CIL and strength. 0.5mg-28, A5.02; 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, A18.79. S All grades of essential hypertension and renovascular hypertension where standard therapy is ineffective or inappropriate. P Hypertension: initially 1mg once daily.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HYPERTENSION 2.4 inhalation anaesthetics, quinidine, digoxin, lithium, carbamazepine, cimetidine, ranitidine, grapefruit juice. A Constipation, dizziness, giddiness, nervousness, headaches, fatigue, flush, paresthesia.
stenosis, post kidney transplant. History of angioneurotic oedema. Aortic or mitral valve stenosis, hypertrophic cardio-myopathy. Systolic BP Q100mmHg before treatment initiation. Permanent haemodialysis. Primary hyperaldosteronism. VERISOP Gerard B Diuretics (q80mg frusemide), hypovolaemia, hyponatraemia, hyperkalaemia. 2MO Hypotension (first dose). Acute MI and cardiac Class I Ca++ antagonist. Verapamil chlor. 40mg, failure (if unstable), renal impairment, high-dose 80g, 120mg. White tabs. marked VL and strength vasodilator therapy. LDL-cholesterol apheresis. one side, G on reverse. 40mg-100, A3.53; 80mgElderly. 100, A5.16; 120mg-100, A10.59. C Diuretics incl. K+sparing, K+suppl., other S Mild to moderate hypertension. antihypertensives, analgesics/anti-inflammatories, P 40-120mg three times daily. lithium, alcohol, anaesthetics, narcotics, hypnotics. Q Not recommended. Sympathomimetics, oral antidiabetic agents, D Cardiogenic shock. 2nd or 3rd degree insulin. AV block. Severe bradycardia. Uncompensated A Hypotension, dizziness, fatigue, cardiac failure. Sick sinus syndrome. arrhythmias. Proteinuria, dry cough, nausea B 1st degree AV block. Poor cardiac (occasionally), abdominal pain, rash, headache. reserve should be controlled with digitalis and VERAMIL Orion diuretics. Hepatic impairment. Acute phase of MI. ZESGER PLUS Gerard 2MO Bradycardia. 5MO C b-blockers, quinidine or digoxin. Class I Ca++ antagonist. Verapamil chlor. 40mg, A Constipation, headache, flushes. 80mg, 120mg. White film-ctd tabs. coded VL-40, ACE inhibitor/diuretic. Lisinopril (as dihydrate) VL-80 and VL-120. 40mg-100, A5.17; 80mg-100, 20mg and HCTZ 12.5mg. Pink, round tab. marked A8.67; 120mg-100, A11.56. LHZ on one side and 32.5 on reverse. 28, A10.75. S Essential hypertension. S Essential hypertension where BP not P 40-120mg three to four times daily. adequately controlled on lisinopril or HCTZ alone. ZANIDIP Recordati P Once daily depending on clinical Severe liver dysfunction: Use 1/3 dose. D Severe left ventricular dysfunction. evaluation at about the same time each day. Max. 2MO Severe hypotension, cardiogenic shock. 2nd or 3rd Class II Ca++ antagonist. Lercanidipine HCl 10mg, 40mg lisinopril/ 25mg HCTZ. degree AV block. Marked bradycardia. Sick sinus Q Under 18 years, not recommended. 20mg. Yellow, pink resp. scored film-ctd tab. syndrome. CHF incl. including uncompensated HF. 10mg-28, A10.93; 20mg-28, A17.85. D Renal artery stenosis. Angioneurotic Lactation. oedema. Severe renal/hepatic impairment. S Mild to moderate essential B 1st degree AV block reported. Pregnancy, lactation. hypertension. Hypertrophic cardiomyopathy, elderly, attenuated P 10mg once a day at least 15 mins. B Symptomatic hypotension may occur, neuromuscular transmission. Mild to moderate HF before meals; may be increased to 20mg. especially in patients with volume/salt depletion. (control with digitalis and diuretics). Porphyria Recent renal transplantation, dialysis; avoid. Q Not recommended. (unsafe). Hepatic impairment (monitor during Anaphylactoid reactions. Risk of hyperkalaemia, D Severe renal/hepatic dysfunction. LV long-term therapy). Contains lactose. Pregnancy. renal impairment, diabetes mellitus, major surgery, outflow tract obstruction. Untreated congestive C Grapefruit juice, digitalis intoxication, IV cardiac failure. Unstable angina pectoris. Within 1 impaired liver function; caution. Withdraw if b-blockers (contra). Colchicine, cisapride (avoid). a/ month of a MI. Pregnancy (women of childneutropenia, angioedema or jaundice occurs. b-blockers, CYP3A4 inhibitors/substrates, C Lithium (avoid). K+ suppls, K+-sparing bearing potential should use adequate antiarrhythmics, CCBs, cardiac glycosides, diuretics or K+-containing salts, trimethoprim, contraception), lactation. theophylline, imipramine, glyburide, doxorubicin, diuretics. Caution: Lisinopril: NSAIDs, other B Sick sinus syndrome, LV dysfunction, paclitaxel, tamoxifen, cimetidine, statins, antihypertensive agents, TCAs, sympatomimetics, ischaemic heart disease. Elderly. Mild/moderate almotriptan, halothane, dantrolene, Ca++ salts, antidiabetics, allopurinol, ciclosporin, lovastatin, renal or hepatic dysfunction. Contains lactose. immunosuppressive agents. HCTZ: Amphotericin B alcohol, lithium, timolol eye drop, quinidine, C Contra: CYP3A4 inhibitors (e.g. (parenteral), carbenoxolone, corticosteroids, antihypertensives. ketoconazole, ritonavir, erythromycin), corticotropine, stimulating laxants, Ca++ salts, A Constipation, headache, dizziness, cyclosporine, grapefruit juice. Avoid: alcohol, fatigue, rash, bradycardia, hypotension, cardiac cardiac glycosides, colestyramine resin, colestipol, CYP3A4 substrates (terfenadine, astemizole, class insufficiency, swelling of ankles. non-depolarizing muscle relaxants, drugs III antiarrhythmics). Caution: CYP3A4 inducers associated with torsades de pointes, sotalol. (anticonvulsants, phenytoin, carbamazepine), VERAP Rowex A Dizziness, headache, fatigue, dry and midazolam, digoxin, b-blockers, cimetidine. persistent cough, hypotension incl. orthostatic 2MO ZESGER Gerard hypotension. Class I Ca++ antagonist. Verapamil (HCl) 120mg, 240mg. Beige scored and green oblong scored 2MO ZESTAN Clonmel both sides; both film-ctd prolonged release tabs. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. 2MO 120mg-30, A5.43; 240mg-30, A10.85. Round, flat beveled edge, square biconvex and S Mild to moderate hypertension. ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. pentagonal biconvex tabs. debossed on one side P 240mg in the morning increasing if marked with strength and scored both sides; with 2.5, 5, 10 and 20 resp. All white with necessary to 240mg twice daily with a 12 hour breakline on other side. 2.5mg-28, A5.38; 5mg-28, 10mg, 20mg white tabs. marked with strength interval. and quadrisected both sides. 2.5mg-28, A4.84; A7.59; 10mg-28, A9.37; 20mg-28, A10.75. R 120mg in the morning, increasing by 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. S Arterial hypertension. 120mg at weekly intervals according to response. S Arterial hypertension. P Initially 5mg in the morning; titrate to Q Not recommended. P Initially 5-10mg once daily in the optimum BP control. Time interval between dose D Cardiovascular shock, recent cardiac morning, increasing in intervals of at least 3 weeks increase q3 weeks. Maintenance, 10-20mg once infarction with complications, grade II and III AV up to 20mg daily maintenance dose. Max. 80mg daily. Max 40mg once daily. Renal dysfunction, block, sinu-atrial blockage, sick sinus syndrome. once daily. A lower initial dose 2.5mg in patients patients who do not tolerate discontinuation of B Monitor BP at regular intervals diuretic treatment, volume/salt depleted, severe or with renal impairment, HF, volume and/or salt particularly in 1st degree AV block, hypotension, depletion, severe or renovascular hypertension, renovascular hypertension, initiate with 2.5mg in bradycardia, atrial fibrillation/flutter or patients who do not tolerate discontinuation of the morning. simultaneous pre-excitation syndrome. Impaired diuretic therapy, elderly. R Initiate with 2.5mg in the morning. hepatic function. Pregnancy, lactation. Q Not recommended. Q Not recommended. C Anti-arrhythmic drugs, b-blockers, D Angioneurotic oedema, severe renal D Pregnancy, lactation. Renal artery Maintenance usually 1-2.5mg once daily. Discontinue any diuretic 2-3 days before initiating therapy with 0.5mg once daily. Renovascular hypertension: initially 0.25-0.5mg once daily. Titrate according to response. R Hypertension: initially 0.5mg once daily. Renovascular hypertension: initially 0.25mg once daily. Q Not recommended. D Ascites, aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction. Pregnancy, lactation. B Haemodialysis. Renal or hepatic impairment, CHF, salt or volume depletion, surgery, anaesthesia. C K+sparing diuretics, NSAIDs. A Headache, dizziness, fatigue, dyspepsia, nausea, rash, coughing. Rarely angioneurotic oedema and alterations in blood count.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
65
2.5 PERIPHERAL
CIRCULATORY SYSTEM
VASCULAR DISORDERS A Dizziness, headache, fatigue, diarrhoea, cough, rash, asthenia, angioedema, renal failure. Hypotension, palpitations, chest pain, impotence.
and marked M6, resp. B.D. Starter pack (8 x 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; 1mg-56, A4.07. S Raynaud’s phenomenon. ZOFENIL A. Menarini P Initially 500mcg twice daily for 3-7 days; maintenance 1-2mg twice daily. 2MO Q Not recommended. Cardioprotective ACE inhibitor. Zofenopril 30mg. D Sensitivity other quinazolines. White oval film-ctd tab. 30mg-28, A14.02. B Pregnancy, lactation. Initial low dose S Hypertension. and gradual titration is recommended, monitor P Usually 30mg once daily; max. 60mg. BP. Q Not recommended. C Other antihypertensives. Caution: PDE-5 D Angioneurotic oedema, severe hepatic inhibitors. impairment, renal artery stenosis. Pregnancy, lactation. Women of child-bearing potenial unless MIDON Shire protected by effective contraception. 0MO B Reduce dosage of diuretic if possible before initiating therap. Volume depletion may a-agonist. Midodrine (HCl) 2.5mg white scored cause sympathetic hypotension, dialysis, tab. marked GU and 2.5. 5mg orange scored tab. anaesthesia, renal or heptic impairment. marked GU and 5.0 2.5mg-100, A58.58; 5mg-100, A117.16. C Other anti-hypertensive agents, diuretics, lithium, K+sparing diuretics, K+suppl., S Idiopathic orthostatic hypotension. P Initially 2.5mg two to four times daily, NSAIDs. ZESTORETIC 20 AstraZeneca A Dizziness, fatigue, headache, cough, gradually increasing by 2.5mg at weekly intervals 5NO until optimal response. Last dose should be taken nausea, vomiting, rash, muscle cramp, weakness. at least 4 hours before bedtime. Max. 30mg daily. ACE inhibitor/thiazide diuretic. Lisinopril 20mg, Q Not recommended. HCTZ 12.5mg. White tab. marked ZESTORETIC 20. 2.5 PERIPHERAL VASCULAR DISORDERS D Hypertension, severe organic heart 28 (Cal/Pk), A6.46. ADALAT Bayer Schering disease, hyperthyroidism, thyrotoxicosis, 5NO 2 M O phaeochromocytoma, acute nephritis or urinary ALSO ZESTORETIC 10 Lisinopril 10mg, HCTZ retention, vasovagal hypotension, narrow angle Class II Ca++ antagonist. Nifedipine 5mg, 10mg. 12.5mg. Peach tab. 28 (Cal/Pk), A9.38. glaucoma. Pregnancy, lactation. Orange, gelatin ovoid caps. containing yellow S Management of hypertension in B Renal insufficiency. Driving/using fluid. 5mg-90, A3.03; 10mg-90, A3.85. patients stabilised on the individual components machines. Contains sunset yellow. S Raynaud’s phenomenon. or where no response to monotherapy with C Sympathomimetic agents, guanethidine, P Initially 5mg eight hourly adjusted lisinopril. reserpine, atropine, antihistamine, thyroid according to response, increasing to max. 20mg P 1 once daily. hormones, methyldopa, tricyclic antidepressants. every 8 hrs. Q Not recommended. MAOIs. Digitalis or other glycosides, Q Not recommended. D Pregnancy. Anuria, aortic stenosis, mineralcorticoids or glucocorticoids. D Women of child-bearing potential, hyperkalaemia, history of angioneurotic oedema. lactation. Cardiogenic shock, aortic stenosis. Acute A Nausea, vomiting, dyspepsia, chills, B First dose hypotension in fluid or headache, dizziness, rash, urinary retention. angina attacks, unstable angina pectoris, MI electrolyte depletion, renal impairment, hepatic Hypotension, tachycardia, arrhythmias, (within 1 month). disease, lactation. + + palpitations, reflex bradycardia, parasthesic, B Poor cardiac reserve, HF, hepatic C K sparing diuretics, K suppl., lithium, impairment, severe hypotension. Diabetes, dialysis. pruritus, flushing, dysuria. indomethacin, antidiabetics, corticosteroids. Elderly. Driving/using machines. Palpitations, A Dizziness, headache, cough, NIFED Rowex hypotension, syncopes, fatigues, rash, GI disorders, hypotension, tachycardia reported. C Contra: Rifampicin. Avoid grapefruit 2MO impotence, muscle cramps, paraesthesia. juice. Caution: Antihypertensive agents, Class II Ca++ antagonist. Nifedipine 10mg. Oblong ZESTRIL AstraZeneca cimetidine, quinidine, digoxin, phenytoin, brown caps. 100, A7.01. diltiazem, cisapride, quinupristin/dalfopristin, S Raynaud’s phenomenon. 2MO CYP3A4 inhibitors. P 30-60mg daily in divided doses. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. A Headache, vasodilatation, nausea, R 15mg in divided doses. White, pink, pink, red tabs. resp. marked with dizziness, peripheral oedema. Q Not recommended. heart shape, strength and ZESTRIL. 2.5mg-28, D Cardiogenic shock. unstable angina A3.23; 5mg-28, A4.56; 10mg-28, A5.63. 20mg-28, HEXOPAL Clonmel pectoris, advanced aortic stenosis, porphyria, acute A6.46. 2O myocardial infarction. Women of child-bearing S All grades of essential and renovascular Nicotinic acid deriv. Inositol nicotinate 500mg. potential. Pregnancy, lactation. hypertension. White scored tab. marked HXV. 100, A20.27. B Caution: Severe hypotension, poor P Initially 10mg once daily; maintenance S Intermittent claudication, Raynaud’s cardiac reserve, diabetes, malignant hypertension, 10-20mg once daily. Renovascular hypertension: disease, peripheral arteriosclerosis, acrocyanosis, irreversible renal failure with hypovolaemia, risk of initiate with 2.5-5mg daily. Discontinue diuretic 2chilblains. hypotensive crisis (medical supervision). 3 days before initiating with 5mg daily or reduce P 2 three times daily. C Not recommended: Rifampicin, antidiuretic dose. Q Not recommended. epileptics. Caution: Cimetidine, erythromycin, Q Not recommended. 2 nefazodone, azole antifungals, digoxin, diltiazem, D History of angioneurotic oedema. Not ALSO HEXOPAL FORTE Inositol nicotinate 750mg. cyclosporine, tacrolimus, vincristine, antidiabetics, recommended: Lactation, pregnancy (contra 2ndWhite oval scored tab. marked HEX 750. 112 (Cal/ qinidine, cisapride. Avoid grapefruit juice. 3rd trim.). Pk), A35.27; 250, A95.87. A Headache, facial reddening, B Renal impairment; monitor renal palpitations, dizziness, leg oedema. P 2 twice daily. function before and during treatment. Aortic stenosis, cor pulmonale, outflow tract obstruction. Q Not recommended. NIMOTOP Bayer Schering B Pregnancy. 1st dose hypotension. Anaphylactoid reactions 2MO (during haemodialysis using high flux membranes, HYPOVASE Pfizer Class II Ca++ antagonist. Nimodipine 30mg. Yellow LDL apheresis, desensitisation). 2MO film-ctd tab. marked with Bayer cross on one side C K+ sparing diuretics, K+ suppl., other and SK on reverse. 100, A42.25. antihypertensives, indomethacin, lithium, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. injectable gold. White tab. marked Pfizer and white tab. scored S Prevention of ischaemic neurological impairment, haemodynamically unstable patients after MI, haemodynamically relevant aortic or mitral valve stenosis or hypertrophic cardiomyopathy, systolic BP R 100 mmHg before initiation of treatment, cardiogenic shock. B Haemodialysis. Hypotension, renovascular hypertension, renal impairment, monitor renal function before and during treatment, severe CHF, primary hyperaldosteronism, aortic stenosis, hypertrophic cardiomyopathy. Low-density apheresis/ desensitisation therapy. C Diuretics, K+ sparing diuretics, K+ suppl., Na+ Cl, lithium, anti-hypertensives, analgesics, anti-inflammatories, alcohol, anaesthetics, narcotics, hypnotics, sympathomimetics, oral antidiabetics, insulin, antacids, NSAIDs. A Hypotension, angioedema, dizziness, weakness, impaired vision, renal dysfunction, dry cough, sore throat, hoarseness, bronchitis, GI disturbances, rash, headache, tiredness.
66
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM deficits following aneurysmal subarachnoid haemorrhage. P 2 tabs. four hourly starting within 4 days of subarachnoid haemorrhage and continued for 21 days. If cerebral ischaemia occurs, continue tab. to complete 21 days or substitute by soln. Q Not recommended.
2N ALSO NIMOTOP SOLUTION Nimodipine 0.2mg/ml. Soln. for inf. in vial. 5 x 50ml vial (with 5 inf. lines), A74.47. S Treatment of ischaemic neurological deficits following aneurysmal subarachnoid haemorrhage. P 1mg per hour by IV inf. for first 2 hrs, then 2mg per hr for min. 5 days, max. 14 days. If surgical intervention during treatment, admin. should be continued for at least 5 days. If tabs. and inf. are admin. sequentially, total duration of treatment should not exceed 21 days. Patients under 70kg or with unstable BP, start on 0.5mg per hr or less if necessary. Q Not recommended. D Unstable angina episode, MI (within 1 month). B Cerebral oedema, raised IOP. Hypotensive patients. Pregnancy. Monitor BP in cirrhotic patients. Renal impairment (inf.) Transient rise in liver enzymes (inf.). Nimotop inf. is incompatible with PVC and contains ethanol, Na+. C Oral nimodipine: Contraindicated with antiepileptics, phenobarbital, phenytoin, carbamazepine, rifampicin. Caution: Quinupristin/ dalfopristin. Nimodipine inf: Caution, nortriptyline, nephrotoxic drugs. Both: Grapefruit juice, not recommended. Caution: Diuretics, b-blockers, ACE inhibitors, A1 antagonists, methyldopa, other Ca++ antagonists, a-adrenergic blocking agents, PDE5 inhibitors, fluoxetine, cimetidine, Na+ valproate, zidovudine, CYP3A4 inducers and inhibitors. Do not use tab. and inf. concomitantly.
PROPHYLAXIS
OF
MI,
STROKE AND VASCULAR DEATH
min. after catheter removal; monitor neurological signs and symptoms), hip fracture surgery (no data). Monitor for bleeding or anaemia during treatment, especially in at-risk patients. Caution: Moderate renal impairment, high surgical mortality risk, thromboembolic risk. Contains sunset yellow. C Contra: Quinidine. Not recommended: Heparins, fondaparinux, desirudin, thrombolytic agents, GPIIb/IIIa receptor antagonists, clopidogrel, ticlopidine, dextran, sulfinpyrazone, vit. K antagonists. Caution: Amiodarone, strong Pglycoprotein inhibitors (e.g. verapamil, clarithromycin), potent P-glycoprotein inducers (e.g. rifampicin, St John’s wort). A Bleeding events, anaemia, haematoma, haematuria, decreased Hb, wound secretion.
PRAXILENE
Merck Serono
2MO Peripheral and cerebral activator. Naftidrofuryl oxalate 100mg. Pink cap. marked PRAXILENE. 100, A11.87. S Cerebral and peripheral vascular disorders. P 1-2 three times daily. Q Not recommended. D History of hyperoxaluria or recurrent Ca++-containing stones. Pregnancy, lactation. A Nausea, epigastric pain, skin rash, insomnia. Rarely; hepatitis, kidney stones.
2.6
B Caution: Patients at increased bleeding risk, renal impairment (ccQ15ml/min, not recommended), moderate hepatic impairment. Spinal/epidural anaesthesia or puncture, monitor for symptoms of neurological impairment. Not recommended for hip fracture surgery. Contains lactose. C Not recommended: CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, voriconazole, posaconazole, HIV protease inhibitors). Caution: Fluconazole, other anticoagulants, clopidogrel, NSAIDs, platelet aggregation inhibitors, strong CYP3A4 inducers. Affects clotting parameters. A Increased GGT, increased transaminases , anaemia, nausea, post-procedural haemorrhage.
2.6 PROPHYLAXIS OF MI, STROKE AND VASCULAR DEATH
ACERYCAL
Servier
2MO
ACE inhibitor / Ca++ antagonist. Perindopril arginine / amlodipine, 5mg/5mg, 5mg/10mg, 10mg/5mg and 10mg/10mg. White tab. engraved with strength on 1 side and Servier logo on the other. 5/5mg, rod-shaped; 5/10mg, square-shaped; 10/5mg, triangular-shaped; 10/10mg, round. 5/ 5mg-30, A25.66; 5/10mg-30, A31.13; 10/5mg-30, A34.41; 10/10mg-30, A39.88. S Substitution therapy for treatment of essential hypertension and/or stable coronary TRENTAL sanofi-aventis artery disease, in patients already controlled with perindopril and amlodipine given concurrently at 2MO same dose level. Xanthine. Pentoxifylline 400mg. Pink oblong P 1 tab./day as single dose, preferably the modified-release ctd tab. 100, A20.64. morning before a meal. Not suitable for initial S Peripheral vascular disease and therapy. cerebrovascular insufficiency. Q Not recommended. P 400mg, 2 or 3 times daily. D Hypersensitivity to ACE inhibitors and Q Not recommended. dihydropyridines. History of angioedema D Acute MI or cerebrovascular accident. associated with previous ACE inhibitor therapy. PRADAXA Boehringer Ing. Massive bleeding or extensive retinal bleeding. Hereditary or idiopathic angioedema. Severe B Monitor patients with hypotension, 2NO hypotension. Shock, including cardiogenic shock. severe coronary artery disease, severe cardiac Obstruction of the outflow-tract of the left Direct thrombin inhibitor. Dabigatran etexilate (as arrhythmias, renal impairment or increased ventricle (e.g. high grade aortic stenosis). Unstable mesilate), 75mg, 110mg. Light blue and cream bleeding tendency. May potentiate effects of angina pectoris (excluding Prinzmetal’s angina). HF capsules filled with yellowish pellets, imprinted insulin or oral antidiabetic agents. Pregnancy, after acute MI (during first 28 days). Pregnancy, with company symbol and R75 and R110 resp. lactation. lactation. 75mg-10, A23.95, 75mg-60, A143.70, 110mgC Hypoglycaemics, antihypertensives, B May rarely occur: Hypersensitivity, 10,A23.95, 110mg-60, A143.70. theophyilline, anticoagulants, antiplatelets, angioedema (discontinue if occurs) or S Primary prevention of venous ketorolac. anaphylactoid reactions during LDL-apheresis and thromboembolic events in adults after elective A GI disorders, flushing, headache, desensitisation, neutropenia, agranulocytosis, total hip replacement surgery or total knee dizziness, agitation, sleep disorders, cardiac thrombocytopenia, anaemia, hepatic failure, replacement surgery. arrhythmias , hypersensitivity reactions including symptomatic hypotension (in patients with salt or P Initially, 110mg within 1-4 hours of anaphylactic / anaphylactoid reactions. volume depletion), hyperkaliemia. Caution: Aortic surgery, then 220mg once daily for 10 days (knee) or 28-35 days (hip). If haemostasis not secured, XARELTO Bayer Schering and mitral valve stenosis, hypertrophic cardiomyopathy, heart failure, collagen vascular initiation of treatment should be delayed. If 2NO disease, immunosuppressant therapy, treatment treatment not started on day of surgery, starting Antithrombotic agent. Rivaroxaban 10mg. Light with allopurinol or procainamide, hepatic dose is 220mg once daily. Moderate renal red, round film-ctd tab. marked with Bayer-cross impairment. Renal impairment: Adjust dosage impairment: Initially 75mg within 1-4 hours of according to individual dose titration with the surgery, then 150mg once daily. Concomitant use one side and 10 and a triangle on the other. 30; 100. Prices on request. monocomponents. Discontinue 1 day prior to with amiodarone: reduce dose to 150mg. S Prevention of venous thromboembolism surgery. Closely monitor glycaemic control in R Over 75 years, initially 75mg within 1-4 hrs of surgery, then 150mg once daily for 10 days (VTE) in adult patients undergoing elective hip or diabetic patients. Contains lactose. knee replacement surgery. C Not recommended: K+-sparing diuretics, (knee) or 28-35 days (hip). P 10mg once daily. Initially, 6-10 hours K+ supplements, K+-containing salt substitutes, Q Under 18 years, not recommended. lithium, estramustine, dantrolene. Caution: after surgery, if haemostasis established. Hip D Severe renal impairment. Active NSAIDs, antidiabetics (insulin, hypoglycaemic surgery: Continue for 5 weeks. Knee surgery: 2 bleeding, organic lesion at risk of bleeding, sulphonamides), CYP3A4 inducers / inhibitors, impairment of haemostasis. Hepatic impairment or weeks. baclofen, corticosteroids, tetracosactide, alphaQ Not recommended. liver disease expected to have impact on survival. blockers, amifostine, TCAs, antipsychotics, D Clinically significant active bleeding. Pregnancy (unless necessary), lactation. Hepatic disease associated with coagulopathy and anaesthetics. Diuretics, sympathomimetics, gold, bB Not recommended: Elevated liver blockers, vasodilatators. clinically relevant bleeding risk. Pregnancy, enzymes (q2xULN), anaesthesia with postoperative indwelling epidural catheters (wait 2 hrs lactation. A Somnolence, dizziness, headache, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
67
2.6 PROPHYLAXIS
OF
MI,
CIRCULATORY SYSTEM
STROKE AND VASCULAR DEATH
patients. Withdraw if patient requires thrombolytic therapy or CABG. Monitor patients with decreased renal function for bleeding. Monitor the anticoagulant effect of heparin by repeated determination of APTT. Perform regular blood tests. ACTILYSE Boehringer Ing. C Clopidogrel, adenosine, dipyridamole, sulphinpyrazone, prostacyclin, warfarin, LWHs, 2N Fibrinolytic. Alteplase 10mg, 20mg, 50mg. Powder ticlopidine, dextran solutions. A Bleeding, nausea, fever, headache. in vials. 10mg-1 pack (1 x 10mg vial, 1 x 10ml WFI), A203.16; 20mg-1 pack (1 x 20mg vial, 1 x ANGIOX The Medicines Co. 20ml WFI, 1 transfer device), A274.26; 50mg-1 2JN pack (1 x 50mg vials, 1 x 50ml WFI, 1 transfer device), A612.01. Antithrombotic. Bivalirudin 250mg. White S MI, pulmonary embolism, ischaemic lyophilised powder for concentrate for soln for inj. stroke. or inf. 10 vials, A5,292.94. P MI/PE: Total dose 100mg IV. MI - over S Anticoagulant in patients undergoing 90 mins. if within 6 hours of symptom onset, over percutaneous coronary intervention (PCI). 3 hours if 6-12 hours. PE - over 2 hours. See SPC. P Intravenous bolus of 0.75mg/kg Ischaemic stroke: Total dose 90mg as IV inf. over followed by inf. of 1.75 mg/kg/hr for duration of 60 mins. with 10% dose admin. as initial IV bolus procedure for up to 4 hours post-PCI. Arterial within 3 hours of onset. See SPC. sheath can be removed 2 hours after inf. Renal Q Not recommended. insufficiency: Monitor ACT, see SPC. Moderate D Current or recent haemorrhage, renal insufficiency: Reduce Inf. rate to 1.4mg/kg/ hr. haemorrhagic diathesis; severe hypertension with Q Under 18 years, no data. known or possible cerebrovascular haemorrhage, D Active bleeding or increased risk of recent trauma, severe liver disease, acute bleeding, severe uncontrolled hypertension, pancreatitis, bacterial endocarditis, active peptic subacute bacterial endocarditis, severe renal ulceration. impairment, dialysis-dependent patients. B Recent surgery, diabetes mellitus, proliferative diabetic retinopathy, hepatic or renal B Not for IM use. Monitor for bleeding. If bleeding observed or suspected stop treatment. dysfunction. Pregnancy, lactation. Avoid No known antidote to bivalirudin, but its effect intramuscular inj. and vascular puncture. wears off quickly. Hypersensitivity reactions C Anticoagulants. reported uncommonly. Fatal anaphylaxis reported A Localised bleeding. Intracerebral very rarely. Caution: Previously treated patients haemorrhage. Bleeding in GI and genitourinary who had developed lepirudin antibodies. Caution: tracts. Nausea, vomiting, headache, rash and Use during b-brachytherapy procedures. Pregnancy pruritus. (unless clearly necessary), lactation (no data). AGGRASTAT MSD C Start Angiox 30 min. after IV unfractionated heparin or 8 hours after SC low 2N molecular weight heparin. Caution: AntiCompetitive GPIIb/IIIa receptor antagonist. coagulants. Tirofiban 0.25mg/ml. Conc. for soln. for infusion. A Bleeding events. 0.25mg/ml-50ml, A232.79. paresthaesia, vertigo, visual disturbances, tinnitus, palpitations, flushing, hypotension, GI disturbances, pruritus, rash, muscle cramps, oedema, peripheral oedema, fatigue, asthenia, dry cough.
hypersensitivity reactions, iron deficiency anaemia.
CAPRIN
Pinewood
2MO Salicylate. Aspirin 75mg, 300mg. Pink ent-ctd tab. 75mg-100, A5.40; 300mg-100, A3.72. S To reduce risk of myocardial infarction in patients with unstable angina or ischaemic stroke or with history of MI. P 1 daily before meal. Q Not recommended. D Active peptic ulceration, coagulation deficiency disorders, lactation. B Reyeâ&#x20AC;&#x2122;s syndrome in children. Avoid: Stroke patients, severe hepatic/renal impairment, history of peptic ulceration or coagulation abnormalities, dehydration. Pregnancy (avoid at term). Elderly. C Hypoglycaemic agents (esp.sulphonylureas), uricosuric agents, methotrexate, antacids, antiepilectic agents (phenytoin & Na+ valproate), sulphonamides, antihypertensives, iron salts and alkali. A Allergic or asthmatic reactions. Bronchospasm.
CLEXANE
sanofi-aventis
2NO Anticoagulant. Enoxaparin Na+ 100mg/ml (equiv. 10,000 IU anti Factor Xa activity). Single dose prefilled syringes. 20mg/0.2ml-10; A29.84; 40mg/ 0.4ml-10; A50.97; 60mg/0.6ml-10; A50.78; 80mg/ 0.8ml-10; A61.46; 100mg/1ml-10;A74.65.
2NO
ALSO CLEXANE FORTE Enoxaparin Na+ 150mg/ml (equiv. 15,000 IU anti Factor Xa activity). Single dose pre-filled syringes. 120mg/0.8ml-10, A108.43; 150mg/1ml-10, A139.48. S Prophylaxis and treatment of venous thromboembolic (VTE) disorders including deep venous thrombosis (DVT) and pulmonary embolism (PE). Prevention of thrombus formation during haemodialysis. Treatment of unstable angina (UA) and non-Q-wave myocardial infarction (NQWMI). S Prevention of early myocardial of acute ST Elevation Myocardial ASASANTIN RETARD Boehringer Ing. Treatment infarction in patients with unstable angina of nonInfarction (STEMI) +/- Percutaneous Coronary Q-wave myocradial infarction with last episode of 2 M O Intervention (PCI) (100mg/ml only). chest pain within 12 hours and with ECG changes Antiplatelet/salicylate. Modified release P Prophylaxis of VTE: Low-mod risk (e.g. dipyridamole 200mg, standard release aspirin and/or elevated cardiac enzymes.To be used with general surgery), 20mg SC inj. 2 hrs pre-op, then 25mg. 60, A12.35. aspirin and unfractionated heparin, under 20mg once daily for 7-10 days. High risk (e.g. S Secondary prevention of ischaemic specialist supervision. orthopaedic surgery), 40mg SC inj. 12 hrs pre-op, stroke and transient ischaemic attacks. P Initially 0.4mcg/kg per min. of the then 40mg once daily for 7-10 days. Medical P One cap. swallowed whole twice daily. diluted soln. by IV infusion for 30 mins. starting patients: 40mg once daily SC inj. for 6-14 days. Intorable headache, only 1 daily at bedtime and within 12 hours of the last angina episode. Then Treatment of DVT or PE: 1.5mg/kg daily SC inj or low dose ASA in morning; return to usual regimen 1mg/kg twice daily SC inj. for complicated VTE. All 0.1mcg/kg per min. by IV infusion for at least 48 asap, usually within 1 week. hours. Max. treatment period 108 hours. for r 5 days and until adequate oral Q Under 16 years, not recommended. Q Not recommended. anticoagulation established. Haemodialysis: R 4 D Active gastric or duodenal ulcers, D Stroke within 30 days, intracranial hrs: 1mg/kg bolus dose into arterial line prior to bleeding disorders. Pregnancy (especially last trim), session. q4 hrs or if fibrin rings found: further disease, GI bleeding within 30 days, malignant lactation. hypertension, surgery or trauma past 6 weeks, dose of 0.5-1mg/kg. Treatment of UA and NQWMI: thrombocytopenia (platelet count Q100,000/mm3), B Severe coronary artery disease, 1mg/kg 12 hourly SC inj. with oral aspirin (100clotting disturbances, severe liver failure. coagulation disorders, asthma, allergic rhinitis, 325mg once daily) for 2-8 days and until clinical Pregnancy, lactation. nasal polyps, chronic or recurring gastric or stabilisation. Treatment of acute STEMI: 30mg B Cardiopulmonary resuscitation, organ duodenal complaints, impaired renal or hepatic single IV bolus plus 1mg/kg SC inj. followed by biopsy or ithotripsy within last 2 weeks, active function or G6PD deficiency, hypersensitivity to 1mg/kg SC inj. every 12 hrs for 8 days or until peptic ulcer within 3 months, uncontrolled NSAIDs. Contains lactose. hosp. discharge. (max 100mg for the first 2 doses hypertension, acute pericarditis, vasculitis, aortic C Adenosine, antihypertensives, only, followed by 1mg/kg for remaining doses). dissection, haemorrhagic retinopathy, haematuria, anticoagulants, other antiplatelets, valproic acid, Elderly (r75 years): do not use initial IV bolus. occult blood in stools. Recent relevant bleeding SSRIs, other NSAIDs, corticosteroids, chronic 0.75mg/kg SC every 12 hrs (max. 75mg for first 2 within 1 year, severe acute or chronic HF, alcohol use, hypoglycaemics, methotrexate, doses only, followed by 0.75mg/kg for remaining cardiogenic shock, mild to moderate liver spironolactone, uricosuric agents. doses). PCI: If the last SC admin was Q 8 hrs insufficiency, platelet function disturbances, A Dizziness, vomiting, diarrhoea, nausea, before balloon inflation, no additional dosing thrombocytopenia (platelet count Q150,000/mm3), dyspepsia, epigastric distress, headache, myalgia, needed. q 8 hrs give 0.3mg/kg IV bolus. anaemia, female, elderly or low body weight hypotension, hot flushes, tachycardia, Q Not recommended.
68
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM D Acute bacterial endocarditis, active major bleeding disorders, high risk of uncontrolled haemorrhage (including recent hemorrhagic stroke or subdural haematoma), thrombocytopenia, jaundice, active gastric/duodenal or hiatal ulcer, threatened abortion, retinopathy. Pregnancy, lactation (unless essential). B Not via IM route. Monitor platelet count (prior to and thereafter during treatment). Increases in aPTT and ACT. Hyperkalaemia. Caution in impaired haemostasis, history of peptic ulcer or bleeding, recent ischaemic stroke, severe arterial hypertension, severe liver or kidney dysfunction, diabetic retinopathy, recent ophtalmologic or neuro surgery or trauma, mechanical prosthetic heart valves (especially in pregnant women), elderly, severe renal impairment (dose adjustment), low body weight, spinal/epidural anaesthesia. C Medications affecting hemostasis: Salicylates, aspirin, NSAIDs, dextran 40, ticlopidine, clopidogrel, systemic glucocorticois, thrombolytics, anticoagulants, other anti-platelet agents (incl. glycoprotein IIb/IIIa antagonists). A Injection site pain, haematoma, mild local irritation. Asymptomatic and reversible increases in platelet counts and liver enzyme levels. Hypoaldosteronism.
PROPHYLAXIS
OF
MI,
STROKE AND VASCULAR DEATH
pathological conditions or treatment, incl. lesions with propensity to bleed (particularly GI and intraocular). Renal impairment, moderate hepatic impairment with bleeding diatheses. Discontinue 7 days prior to surgery. Monitor carefully for any signs of bleeding, especially during 1st weeks and after invasive cardiac procedures or surgery; perform blood count and appropriate test if bleeding suspected. Not recommended during the 1st 7 days after acute ischaemic stroke. Thrombotic Thrombocytopenic Purpura reported very rarely. Contains hydrogenated castor oil. C Avoid anticoagulants. Caution: ASA, heparin, thrombolytics, glycoprotein IIb/IIIa inhibitors, NSAIDs incl. Cox-2 inhibitors. A Haematoma, epistaxis, GI disorders, bruising, bleeding at puncture site.
CLOPIDOGREL TAD
Clonmel
2MO
Antiplatelet. Clopidogrel (HCl) 75mg. Pink, round and slightly convex film-ctd tab. 28, A33.58. S Prevention of atherothrombotic events in adult patients suffering from MI (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. P Single daily 75mg dose. Q Safety and efficacy not established. CLODEL Rowex D Severe liver impairment. Active 2MO pathological bleeding such as peptic ulcer or Antiplatelet. Clopidogrel (as HCl) 75mg. Pink, film- intracranial haemorrhage. Pregnancy, lactation A ctd, round shaped tab. 28, 36.43. (precautionary measure). S Prevention of atherothrombotic events B Not recommended: Acute ischaemic in adults suffering from MI (from a few days until stroke (within 7 days). Caution: Patients at risk of Q 35 days), ischaemic stroke (from 7 days until Q increased bleeding from trauma, surgery or other 6 months) or established peripheral arterial pathological conditions or treatment, incl. lesions disease. with propensity to bleed (GI and intraocular); P 75mg daily as single dose. renal impairment, patients with moderate hepatic D Severe liver impairment. Active disease who may have bleeding diatheses. pathological bleeding (peptic ulcer or intracranial Discontinue 7 days prior to surgery. Consider haemorrhage). Pregnancy, lactation (no data). blood cell count determination and/or other B Not recommended: Acute ischaemic appropriate testing if clinical symptoms suggestive stroke (within 7 days). Caution: Renal impairment, of bleeding arise during treatment. Thrombotic moderate hepatic impairment in patients with Thrombocytopenic Purpura (TTP) reported very bleeding diatheses. Risk of bleeding (caution: rarely. Contains hydrogenated castor oil. Trauma, GI or intraocular lesions with a propensity C Not recommended: Anticoagulants. to bleed, surgery); discontinue 7 days prior to Caution: ASA, heparin, thrombolytics, glycoprotein elective surgery; warn patients to report unusual IIb/IIIa inhibitors, NSAIDs. bleeding. Thrombotic Thrombocytopenic Purpura A Haematoma, epistaxis, GI disorders, reported rarely. Contains hydrogenated castor oil. bruising, bleeding at puncture site. C Not recommended: Oral anticoagulants. COVERSYL ARGININE Servier Caution: Glycoprotein IIb/IIIa inhibitors, acetylsalicylic acid, heparin, thrombolytics, NSAIDs. 2 M O A Haematoma, epistaxis, GI disorders (incl. ACE inhibitor. Perindopril arginine 5mg, 10mg. haemorrhage), bruising, bleeding at puncture site. 5mg: Light green, rod-shaped scored film-ctd tab with a symbol. 10mg: Green, round, biconvex, CLOPIDOGREL HCS Teva film-ctd tab with heart on one side and symbol on 2MO reverse. 5mg-30, A14.12; 10mg-30, A22.59. Antiplatelet. Clopidogrel (HCl) 75mg. Pink, round, S Stable coronary artery disease slightly convex film-ctd tab. 28, A 34.79. reduction of risk of cardiac events in patients with S Prevention of atherothrombotic events history of MI and/or revascularisation. in patients suffering from MI (from a few days to P 10mg once daily. Initially, 5mg once Q 35 days), ischaemic stroke (from 7 days to Q 6 daily for 4 weeks, if tolerated increase to 10mg months) or established peripheral arterial disease. once daily. Discontinue diuretic 3 days P Single daily dose of 75mg. beforehand. If not possible commence with 2.5mg. Q Children and adolescents, not Renal insufficiency, 2.5mg according to creatinine recommended. clearance. D Severe liver impairment. Active R Initially, 2.5mg once daily; increase to pathological bleeding such as peptic ulcer or 5mg after 4 weeks, then 10mg if necessary. intracranial haemorrhage. Pregnancy, lactation Q Not recommended. (precautionary measure). D ACE inhibitor hypersensitivity. History of B Caution: Patients at risk of increased angioneurotic oedema (previous ACE treatment), bleeding from trauma, surgery or other hereditary or idiopathic angioedema. Pregnancy,
2.6
lactation. B Symptomatic hypotension may occur in patients with salt or volume depletion. Caution: Mitral valve stenosis, obstruction in the outflow of the left ventricle. Renal impairment. Dialysis with highflux membranes. Kidney transplantation, no data. Angioedema reported rarely (discontinue if occurs). Patients at risk of hyperkalaemia. Contains lactose. Surgery, anaesthesia. C Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium, NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anesthetics, sympathomimetics. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension, cough, dyspnoea, GI disorders, rash, pruritus, muscle cramps, asthenia.
GREPID
Pinewood
2MO Antiplatelet. Clopidogrel (as besilate) 75mg. Pink, round, biconvex, film-ctd tab. 28, A34.79. S Prevention of atherothrombotic events in adult patients suffering from MI (from a few days to Q 35 days), ischaemic stroke (from 7 days to Q 6 months) or established peripheral arterial disease. P Single daily dose of 75mg. D Severe liver impairment. Active pathological bleeding (peptic ulcer or intracranial haemorrhage). Pregnancy, lactation (precautionary measure). B Not recommended during 1st 7 days after acute ischaemic stroke. Caution: Patients at risk of increased bleeding from trauma, surgery or other pathological conditions or treatment, including lesions with a propensity to bleed (particularly GI and intraocular); renal impairment, moderate hepatic disease with bleeding diatheses. Discontinue 7 days prior to surgery. Monitor carefully for any signs of bleeding, especially during the 1st weeks of treatment and/or after invasive cardiac procedures or surgery; perform blood count and appropriate test if bleeding suspected. Thrombotic Thrombocytopenic Purpura (TTP) reported very rarely. Contains lactose. C Not recommended: Anticoagulants. Caution: ASA, heparin, thrombolytics, glycoprotein IIb/IIIa inhibitors or NSAIDs (incl. Cox-2 inhibitors). A Haematoma, epistaxis, GI disorders, bruising, bleeding at puncture site.
HEPSAL
Pinewood
2NO Anticoagulant. Heparin Na+ 10units/ml in saline, preservative free. Amp. 10 x 5ml, price on request. D Not for systemic use.
INNOHEP
LEO Pharma
2NO Anticoagulant. Tinzaparin 20,000 anti-Factor Xa IU per ml. Syringes x 10: 10,000 IU-0.5ml, A77.47; 14,000 IU-0.7ml, A108.13; 18,000 IU-0.9ml, A139.44. Vial x 1: 20,000/ml-2ml, A28.86. S Venous thrombosis and thromboembolic disease incl. deep vein thrombosis and pulmonary embolism. P 175 IU/kg body weight once daily by SC inj. for at least 6 days and until adequate oral anticoagulation is achieved. Routine monitoring of anticoagulant effect not necessary. Q Not recommended.
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
69
2.6 PROPHYLAXIS
OF
MI,
occurs. Hepatic impairment. Increased risk of bleeding with thrombolytics, oral anticoagulants, dextran solns., adenosine, LMWH, sulphinpyrazone, prostacyclin, NSAIDs, dypyridamole, ticlopidine, clopidogrel. Pregnancy. C Other parenteral GPIIb/IIIa inhibitors. A Bleeding or cardiac events.
C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives, rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (e.g. cholestyramine; admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Insomnia, headache, fatigue, dizziness, Novartis GI disorders, arthralgia.
ALSO INNOHEP 10,000 IU/ML Tinzaparin 10,000 anti-Factor Xa IU per ml. Fixed dose syringes and vials. 2500 IU, A25.12; 3500 IU, A35.16; 4500 IU, A45.20 (syringes x10); 10,000/ml-2ml (vials x 10), A144.34. S Prophylaxis of deep vein thrombosis. Prevention of clotting in in-dwelling intravenous lines for extracorporeal circulation during haemodialysis. P Prophylaxis of DVT: Admin. by SC route only. Low to moderate risk DVT, e.g. all general surgery, 3500 IU starting 2 hrs before surgery. Admin. dose once daily for 7-10 days post-op. or for the required period of cover. High risk of DVT, e.g. orthopaedic surgery, either 4,500 IU starting 12 hrs pre-op. and followed by once daily dose or alternatively 50 IU/kg 2 hrs before surgery followed by once daily dose. Haemodialysis: Shortterm haemodialysis (Q4 hrs) bolus dose of 20002500 IU into arterial side of dialyser (or IV) at beginning of dialysis. Long term haemodialysis (q4 hrs) bolus dose of 2500 IU into arterial side of dialyser (or IV) at beginning of dialysis followed by inf. of 750 IU/hr. Q Not recommended. D Haemorrhagic tendency, incl.: Uncontrolled severe hypertension, severe liver failure, septic endocarditis, intracranial haemorrhage, injuries/operations on CNS, eyes or ears, active peptic ulcer, threatened abortion, heparin induced thrombocytopenia. Spinal/ epidural anaesthesia (full dose).Vials in premature babies and neonates. B Do not admin. by IM inj. Severe renal failure, increased risk of bleeding complications. Regular platelet counts necessary. Increased risk of hyperkalaemia. Sulphite sensitivity (20,000IU/ml). Pregnancy (avoid 2ml vial), lactation. C Caution: Drugs affecting platelet function, salicylates, NSAIDS, vitamin K antagonists, dextran. A Bleeding events, reversible increase in liver enzymes, reversible thrombocytopenia, skin reactions.
ALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. Brown/yellow caps. marked with XU, strength and company logo. 20mg-28 (Cal/Pk), A6.98; 40mg-28 (Cal/Pk). A8.23; 40mg-56 (Cal/Pk), A15.43. S Secondary prevention of major adverse cardiac events (coronary revascularization, cardiac death and non-fatal MI) in patients with CHD after coronary transcatheter therapy. P 80mg daily. Q Under 18 years, not recommended. D Active liver disease or persistent unexplained elevation of transaminase levels, cholestasis. Myopathic disorders. Caution if history of liver disease, high alcohol consumption. Pregnancy, lactation. B Monitor serum transaminase levels before and periodically during treatment. Severe renal impairment. Unexplained diffuse myalgias, muscle tenderness, muscle weakness and/or marked elevated creatine phosphokinase (CPK) values due to myopathy, myositis or rhabdomyolysis; discontinue. C Cholestyramine (admin. min. 4 hrs before Lescol). Caution: Rifampicin, warfarin, immunosuppressants (incl. cyclosporin), gemfibrozil, nicotinic acid, erythromycin, glibenclamide. A Dyspepsia, abdominal pain, nausea, insomnia, headache.
INTEGRILIN
LOCHOL
GSK
LESCOL XL 2MO
Statin. Fluvastatin (as Na+) 80mg. Yellow prolonged release tab. marked LE one side, NVR on reverse. 28 (Cal/Pk), A10.91.
2MO
Clonmel
2MO
2N
Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 Antiplatelet. Eptifibatide 2mg/ml soln. in vial for hard cap. with blue or green cap and white body. inj.; 0.75mg/ml soln. in vial for inf. Inj.-10ml, 20mg-28, A7.56; 40mg-28, A8.92. A20.77. Inf.-100ml, A65.21. S Secondary prevention of coronary S Prevention of early myocardial infarction in patients with unstable angina or non- events in patients with coronary heart disease after coronary transcatheter therapy. Q-wave MI with the last episode of chest pain P 80mg daily. within 24 hours and with ECG changes and/or elevated cardiac enzymes. For use with aspirin and Q Under 18 years, not recommended. D Active liver disease, or unexplained, unfractionated heparin. persistent elevations in serum transaminases. P Initially 180mcg/kg by IV bolus inj., Pregnancy, lactation. followed by continuous inf. of 2mcg/kg/min. for B Monitor liver function before and up to 72 hours. If percutaneous coronary periodically during treatment; discontinue if intervention (PCI) is performed during therapy, increase in AST or ALT exceeds 3 x ULN and continue inf. for 20-24 hours post-PCI for a total persists. Caution: History of liver disease, heavy max. duration of 96 hours. alcohol consumption. Caution (measure CK levels Q Under 18 years, not recommended. before starting treatment): Renal impairment, D GI, genitourinary or other abnormal bleeding within previous 30 days. Stroke within 30 hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of days or history of haemorrhagic stroke. muscular toxicity with a statin or fibrate, alcohol Intracranial disease. Major surgery or severe trauma within past 6 weeks. Thrombocytopenia, abuse, elderly (if other predisposing factors prothrombin time q1.2 times control or INR q2. present). May occur: Myopathy (rarely), myositis Severe hypertension. Severe renal or hepatic and rhabdomyolysis (very rarely); advise patients impairment. Hiistory of bleeding diathesis. to promptly report if occur; stop treatment if CK Lactation. levels q5 x ULN. If symptoms are severe and cause B Monitor patients for bleeding. Stop daily discomfort, consider discontinuation even if immediately if thrombolytic therapy or emergency CK levels Q5 x ULN. Homozygous familial cardiac surgery required or if serious bleeding hypercholesterolemia: Not recommended.
70
CIRCULATORY SYSTEM
STROKE AND VASCULAR DEATH
LUVINSTA
Actavis
2MO Statin. Fluvastatin (as Na+) 20mg, 40mg. Resp. orange/ivory or orange/yellow opaque hard cap. marked with FST and strength. 20mg-28, A10.93; 40mg-28, A12.89. S Secondary prevention of coronary events in patients with CHD and hypercholesterolaemia after percutaneous coronary intervention. P 40mg twice daily. D Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy, lactation. B Monitor liver function before and periodically during treatment; discontinue if increase in AST or ALT q 3 x ULN persists. Caution: History of liver disease, heavy alcohol consumption, pre-disposing factors for rhabdomyolysis (measure CK levels before starting treatment). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur. Discontinue if interstitial lung disease occurs. Homozygous familial hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives (monitor prothrombin times), rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Headache, fatigue, dizziness, GI disorders, joint pain, insomnia.
METALYSE
Boehringer Ing.
2N Fibrinolytic. Tenecteplase 40mg (8 000 IU), 50mg (10 000 IU). Powder in vial and pre-filled syringe containing powder and solvent for soln. for inj. 40mg-1,A1184.96; 50mg-1,A1244.20. S Thrombolytic treatment of suspected MI with persistent ST elevation or recent left Bundle Branch Block within 6 hours after the onset of acute MI symptoms. P Admin. on the basis of body weight as a single IV bolus over 10 secs, max. 10,000 IU. Under 60kg, 6,000 IU; 60-70kg, 7,000 IU; 70-80kg, 8,000 IU; 80-90kg 9,000 IU; q90kg, 10,000 IU. Adjunctive therapy: Patelet inhibitors and anticoagulants should be admin. according to guidelines. Unfractionated heparin and enoxaparin have been used. Acetylsalicylic acid should be initiated as soon as possible after symptom onset and continued with lifelong treatment unless contraindicated. Q Under 18 years, not recommended. D Bleeding disorders within past 6 months, CNS damage, haemorrhagic diathesis, severe uncontrolled hypertension, major surgery within past 2 months, recent trauma of the head, cardiopulmonary resuscitation within the past 2 weeks, acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, severe hepatic
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
PROPHYLAXIS
OF
MI,
STROKE AND VASCULAR DEATH
D Hypoprothrombinaemia, haemophilia, cerebral haemorrhage, active peptic ulceration, lactation. B Not for short-term relief of pain. Renal, cardiac or hepatic impairment. May induce GI haemorrhage. Long-term use, elderly; review regularly. Caution: History of IBD, coagulation abnormalities. Hypertension, monitor. Pregnancy (avoid at term). C Avoid: Warfarin, heparin, other NSAIDs, antacids (simultaneous use). Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporine, tacrolimus, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, anticoagulants, antiplatelets, fibrinolytics, carbonic anhydrase inhibitors, ibuprofen. MICARDIS Boehringer Ing. A Asthma, urate kidney stones, chronic GI blood loss, tinnitus, nausea, vomiting. 2MO Angiotensin II antagonist. Telmisartan 20mg, OMACOR Solvay 40mg, 80mg. White tabs. marked 50H, 51H, 52H 2MO resp. on one side and company symbol on other. 20mg: Round. 40mg, 80mg: Oblong. 20mg-28, Polyunsaturated fatty acid. Omega-3-acid ethyl A19.16; 40mg-28, A19.16; 80mg-28, A23.14. esters 1000 mg (including EPA and DHA 840 mg). S Reduction of cardiovascular morbidity in Soft, oblong, transparent gelatin caps. containing pale yellow oil. 28, A17.56. patients with manifest atherothrombotic cardiovascular disease (history of coronary heart S Secondary prevention after MI, in disease, stroke, or peripheral arterial disease) or addition to other standard therapy. type 2 diabetes mellitus with documented target P 1 daily with food. organ damage. Q Not recommended. P 80mg once daily. Close monitoring of D Pregnancy, lactation (no data). BP recommended. B Exogenous hypertriglyceridaemia (type 1 Q Not recommended. hyperchylomicronaemia); not indicated. Hepatic D Biliary obstructive disorders, severe impairment (monitor hepatic function, especially hepatic impairment. Pregnancy, lactation. with high dosage). Patients at high risk of B Mild moderate hepatic impairment, haemorrhage. Moderate increase in bleeding time renovascular hypertension, renal impairment, may occur with high dosage (i.e. 4 cap.) kidney transplant, intravascular volume depletion C Oral anticoagulants (monitor and adjust (correct prior to admin.), RAA stimulation, primary dose). aldosteronism, aortic and mitral valve stenosis, A GI disturbances. obstructive cardiomyopathy. May cause hyperkalaemia (monitor serum K+ in at risk PENDREX Rowex patients). Contains sorbitol. Apparently less 2MO effective in black patients than other racial ACE inhibitor. Perindopril tert-butylamine 2mg, groups, ischaemic cardiopathy or CVD. C Not recommended: K+ sparing diuretics 4mg, 8mg. White, round, biconvex tablet debossed with 2, 4 or 8 on one side. 2mg-30, or K+ supplements, lithium. Caution: NSAIDs, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. diuretics, heparin, immunosuppressors, S Reduction of risk of cardiac events in trimethoprim. Concomitant use to be taken into patients with a history of MI and/or account: Other antihypertensives, baclofen, revascularisation. amifostine alcohol, barbiturates, narcotics or P Initially 4mg once daily for 2 weeks, antidepressants, systemic corticosteroids. increased to 8mg depending on renal function. MONOPARIN CP Pharm. Renal impairment: See SPC. R 2mg once daily week 1, 4mg once daily 2N week 2, increased to 8mg depending on renal Anticoagulant. Heparin Na+ 25 000units/ml in WFI. function. Preservative-free, single dose amps. 10 x 0.2ml (5 Q Not recommended. 000 IU), price on request. D History of angioedema associated with MULTIPARIN Pinewood previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. 2N B If unstable angina pectoris occurs in 1st Anticoagulant. Heparin Na+ 1000, 5000 units/ml in month, reappraise benefit/risk before continuing WFI. Multidose vials. 10 x 5ml, prices on request. treatment. Volume depletion, symptomatic HF may cause symptomatic hypotension. Caution: NU-SEALS 75 Alliance Mitral valve stenosis, aortic stenosis, hypertrophic 2MO cardiomyopathy, collagen vascular disease, Salicylate. Aspirin 75mg. White ent-ctd tab. immunosuppressant therapy, treatment with marked with strength. 28, A1.90; 56, A3.81. allopurinol or procainamide, diabetes. Renal S Prevention of secondary MI. impairment: Adjust dosage according to cc and Antithrombotic in patients with unstable angina response to treatment. Anaphylactoid reactions or ischaemic stroke. may occur during dialysis with high flux P Acute: 2 tabs chewed. Maintenance: 1 membrane or low-density lipoproteins apheresis tab. daily. with dextran sulphate. Discontinue if angioedema Q Not recommended. occurs. May occur: Hepatic syndrome, neutropenia/ dysfunction, active peptic ulceration, arterial aneurysm, neoplasm with increased bleeding risk, history of dementia. History of haemorrhagic stroke or stroke of unknown origin; or of ischaemic stroke/TIA in the preceding 6 months. B Bleeding, systolic BP q160mmHg, cerebrovascular disease, recent GI or genitourinary bleeding, left heart thrombus, elderly over 75 years, low body weight, arrhythmias. Primary percutaneous coronary intervention (metalyse should not be given). A Reperfusion arrhythmias, bleeding, epistaxis, GI haemorrhage, nausea, vomiting, ecchymosis, urogenital haemorrhage, superficial bleeding, decreased BP, increased body temperature.
2.6
agranulocytosis, thrombocytopenia, anaemia, persistent non-productive cough, elevation in serum K+. Discontinue 1 day prior to surgery. C Avoid: Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, antipsychotics, anaesthetics, sympathomimetics, antacids. A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia.
PERSANTIN RETARD
Boehringer Ing.
2MO Antiplatelet. Dipyridamole 200mg. Red/orange modified release hard gelatin cap. containing yellow pellets. 60, A12.80. S Secondary prevention of ischaemic stroke and transient ischaemic attacks either alone or in conjunction with aspirin. Adjunct to oral anti-coagulation for prophylaxis of thromboembolism associated with prosthetic heart valves. P 1 twice daily with meals. Caps. should be swallowed whole without chewing. Q Not recommended. D Acute hypotension, particularly after MI. B Severe coronary artery disease (unstable angina, recent MI, LV outflow obstruction, haemodynamic instability), myasthenia gravis, coagulation disorders. Pregnancy, lactation. C Adenosine, oral anticoagulants, hypotensive agents, cholinesterase inhibitors. A GI disturbances, dizziness, nausea, headache, myalgia, hypotension, hot flushes, tachycardia, hypersensitivity reactions (rash, urticaria, bronchospasm).
PLAVIX
sanofi-aventis/BMS
2MO Antiplatelet. Clopidogrel (hydrogen sulphate) 75mg, 300mg. Pink film-ctd tabs. 75mg round marked 75 and 1171. 300mg oblong marked 300 and 1332. 75mg-28, A45.54 (GMS); 300mg-30, A202.48 (not GMS). S Prevention of atherothrombotic events in patients suffering from MI (from a few days until less than 35 days), ischaemic stroke (from 7 days until less than 6 months) or established peripheral arterial disease. In combination with aspirin in non-ST segment elevation acute coronary syndrome (unstable angina or non-Q wave MI) and ST segment elevation acute MI (STEMI) in medically treated patients eligle for thrombolytic therapy. P 75mg daily. Non-ST segment elevation acute coronary syndrome: 300mg followed by 75mg daily given in combination with 75-100mg aspirin daily. STEMI: 300mg followed by 75mg daily in combination with aspirin +/- thrombolytics (no loading dose in patients q75 years). Q Under 18 years, not recommended. D Severe liver impairment, active bleeding (peptic ulcer or intracranial haemorrhage). Pregnancy, lactation (no data). B Not recommended: Acute ischaemic stroke (within 7 days). Caution: Renal impairment, moderate hepatic impairment in patients with bleeding diatheses. Risk of bleeding (caution: Trauma, GI or intraocular lesions with propensity to bleed, surgery); discontinue 7 days prior to elective surgery; warn patients to report unusual
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
71
2.6 PROPHYLAXIS
OF
MI,
Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, haemoglobin content and platelet count, hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile membranes and low-density lipoprotein apheresis with dextran sulphate. C Caution: Antidiabetics, NSAIDs. PRINDACE Clonmel A Nausea, dizziness, headache, symptomatic hypotension, MI, cerebrovascular 2MO accident, chest pain, palpitations, rhythm ACE inhibitor. Perindopril tert-butylamine 4mg, disturbances, angina pectoris, impaired renal 8mg. 4mg-30, A7.24; 8mg-30, A11.56. function, GI disorders, hypersensitivity reactions, S Reduction of risk of cardiac events in cutaneous and mucosal reactions, vasculitis, muscle patients with history of MI and/or and joint pains, fever or eosinophilia, dry tickling revascularisation. P Initially, 4mg once daily for two weeks, cough, disturbances of balance, nervousness, restlessness, terror, sleep disorders, confusion, loss if tolerated then increase to 8mg once daily of appetite, depressed mood, feeling of anxiety, depending on renal function. Renal impairment, paraesthesiae, taste change/reduction/loss, muscle see SPC. cramps, erectile impotence, reduced sexual desire, R Initially 2mg once daily for one week, increased blood urea nitrogen and serum then 4mg once daily the next week, before creatinine, deterioration of pre-existing increasing up to 8mg once daily depending on proteinuria. renal function. Q Under 18 years, not recommended. RAPILYSIN Actavis D Angioedema. Pregnancy, lactation. 2N B Increased risk of symptomatic Fibrinolytic. Reteplase 10 units. Powder in vial. 1 hypotension eg. salt depletion, hypovolaemia, pack-(2 vials, 2x10ml WFI, 2 transfer devices, 2 diuretics; correct, if possible, prior to therapy. + needles), A1163.08. Monitor BP, renal function, serum K closely, S Acute myocardial infarction. before and during treatment. Hyperkalemia, P Two x 10 unit bolus inj.s 30 mins. apart, increases in blood urea and plasma creatinine. each by slow IV inj. over max. 2 mins. within 12 Caution: Mitral valve stenosis, obstruction in the hrs of MI. See SPC. outflow of left ventricle, diabetes. LDL apheresis. Q Not recommended. Jaundice, angioedema (facial/ intestinal) reported rarely; discontinue promptly. Discontinue one day D Haemorrhagic diathesis, intracranial neoplasm, arteriovenous malformation or prior to surgery. Contains lactose. aneurysm, CVA, within 10 days of external heart C Lithium, K+ supplements (not recommended), diuretics. Caution: NSAIDs, massage, uncontrolled hypertension, active peptic antihypertensives, vasodilators, antidiabetics, ulceration, portal hypertension, severe renal or anaesthetics, TCAs, antipsychotics, liver dysfunction, acute pancreatitis, pericarditis, sympathomimetics, injectable gold. bacterial endocarditis, within 3 months of severe A Hypotension, headache, dizziness, bleeding, surgery or major trauma, neoplasm with vertigo, paraesthesia, vision disturbance, tinnitus, increased bleeding risk, pregnancy, lactation. cough, dyspnoea, GI disorders, dysgeusia, B Cerebrovascular disease, systolic BP dyspepsia, rash, pruritus, muscle cramps, asthenia. above 160mmHg, recent GI or genito-urinary bleeding, increased risk of left heart thrombus, RAMYTE Actavis septic thrombophlebitis or occluded arteriovenous cannula, increased risk of bleeding. Elderly. 2MO C Anticoagulants, drugs affecting platelet ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 function, Vit. K antagonists, heparin. hard cap. containing white powder, with light A Haemorrhage, arrhythmias, grey body and resp. light green, green or dark hypotension, recurrent angina, heart failure. green cap, marked R on cap and strength on body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, REFLUDAN Pharmion A10.92. 2N S Prevention of MI, stroke or Recombinant DNA anticoagulant. Lepirudin 50mg. cardiovascular death in patients with increased Powder in vial for soln. 10 x 50mg. Price on cardiovascular risk, already taking standard request. therapy and in type 2 diabetic patients with S Heparin-induced thrombocytopenia increased cardiovascular risk. P Initially, 2.5mg once daily. Double dose (HIT) type II and thromboembolic diseases requiring antithrombotic therapy. after 1 week, after 3 further weeks increase to P Initially 0.4mg/kg body weight followed 10mg. Maintenance: 10mg daily. Renal/hepatic by 0.15mg/kg body weight per hour as continuous impairment, see SPC. IV inf. for 2-10 days. See SPC. R Caution. Q Not recommended. D History of angioneurotic oedema D Pregnancy, lactation. Recent puncture relating to previous ACE inhibitor treatment. of large vessels, organ biopsy, cardiovascular Pregnancy, lactation. Use in children. accident, recent major surgery, overt signs of B Aortic stenosis or outlaw obstruction bleeding, uncontrolled hypertension or bacterial (not recommended). Renal impairment risk (dosage reduction and/or discontinue); assess renal endocarditis. B Renal insufficiency. Monitor APTT levels function prior to and during treatment. Caution: bleeding. Thrombotic Thrombocytopenic Purpura reported rarely. CYP2C19 poor metaboliser status (diminished response). Contains lactose, hydrogenated castor oil. C Not recommended: Oral anticoagulants, CYP2C19 inhibitors, PPIs. Caution: Glycoprotein IIb/ IIIa inhibitors, aspirin, heparin, thrombolytics, NSAIDs. A GI Bleeding, bleeding at puncture site, bruising, haematoma, epistaxis, GI disturbances.
72
CIRCULATORY SYSTEM
STROKE AND VASCULAR DEATH
during prolonged therapy. C Thrombolytics. A Bleeding at puncture site, epistaxis, GI bleeding, haematoma, anaemia, allergic reactions, fever, kidney failure.
REOPRO
Lilly
2N Antiplatelet. Abciximab 2mg per ml. Colourless and clear soln in vial. 10mg/5ml-1, A352.07. S Adjunct to heparin and acetylsalicylic acid for the prevention of ischaemic cardiac complications in patients undergoing percutaneous coronary intervention (balloon angioplasty, atherectomy, and stent). Adjunct to heparin and acetylsalicylic acid for short-term (1month) reduction of MI risk, in patients with unstable angina, not responding to full conventional therapy who have been scheduled for percutaneous coronary intervention. P 0.25mg/kg by bolus IV 10-60 mins. prior to PTCA and immediately followed by a 0.12510mcg/min. continuous IV inf. for 12 hours. Angina patients, start up to 24hours prior to PTCA, Admin. oral acetylsalicylic acid at least 300mg daily. Admin. heparin in a low-dose weight adjusted regimen; see SPC. Q Not recommended. D Hypersensitivity to murine monoclonal antibodies or to papain (may contain traces). Active internal bleeding, cerebrovascular accident within 2 years, recent intracranial or intraspinal surgery or trauma, recent major surgery, intracranial neoplasm, arteriovenous malformation or aneurysm, bleeding diathesis, severe uncontrolled hypertension, thrombocytopenia, vasculitis, hypertensive retinopathy, severe hepatic failure, severe renal failure (requiring haemodialysis). Pregnancy, lactation. B Identify pre-existing coagulation abnormalities before treatment (measure platelet count, ACT, prothrombin time, APTT). Risk of anaphylaxis; cardio-pulmonary resuscitation facilities must be available. Perform full blood tests and platelet counts before and after therapy; transfuse platelets if count drops below 50,000 cells/mcl. Careful attention to potential bleeding sites; minimise venous sheaths use, only puncture anterior wall of artery/vein when establishing vascular access. Pretreat with H2 antagonist to prevent GI bleeding. Pulmonary haemorrhage may occur rarely. Discontinue if serious uncontrolled bleeding occurs or if emergency surgery needed. Renal/ peripheral vascular disease. See SPC. C Additive effect with thrombolytics. A Thrombocytopenia, bradycardia, nausea, vomiting, chest pain, pyrexia, puncture site pain, back pain, headache, bleeding; hypotension.
WARFANT
Antigen
2MO Coumarin anticoagulant. Warfarin Na+ 1mg brown scored tab. 3mg blue scored tab. 5mg pink scored tab. Marked W1, W3 or W5. 1mg-100, A3.09; 3mg-100, A5.03; 5mg-100, A7.11. S Prophylaxis against venous thrombosis and pulmonary embolism and treatment of these conditions to prevent their extension. Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. V See lit. D Pregnancy. Within 3 days of surgery. B Avoid abrupt withdrawal. Monitor prothrombin times. Renal or hepatic impairment,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HAEMORRHAGE 2.7
severe hypertension. Elderly. Patients at risk of serious haemorrhage. Warfarin resistance (suspect if unusually large dose required). See SPC. C Alcohol, aspirin, NSAIDs, oral hypoglycaemics, cimetidine. Other drugs and remedies (e.g. St John’s Wort). See SPC. A Bleeding, skin rashes,purpura, ecchymosis, skin necrosis, alopecia, diarrhoea, fall in haematocrit, jaundice, liver dysfunction, fever, nausea, vomiting, pancreatitis, hypersensitivity reactions. See SPC.
WARFARIN TEVA
Teva
2MO Coumarin anticoagulant. Warfarin (Na+) 1mg, 3mg. 5mg Brown, blue, pink flat, caps. shaped scored tabs with WARFARIN on top of TARO marked on one side and 1, 3, 5 on reverse, resp. Score line only to facilitate swallowing; not to divide into equal doses. 1mg-100, A2.96; 3mg-100, A4.83; 5mg-100, A6.83. S Prophylaxis of venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. Prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation. P Initially, 10mg daily for 2 days; then adjust according to results of prothrombin time, usually reported as the INR. Daily maintenance, usually 3-9mg at same time each day. Q Not recommended. D Pregnancy. Within 3 days of surgery. B Perform baseline coagulation screen and liver function before therapy. Monitor prothrombin times. Renal or hepatic impairment, severe hypertension, cerebrovascular disease, HF, elderly, patients at risk of serious haemorrhage (see SPC). Warfarin resistance. Skin necrosis reported. Withdraw gradually. C Contra: St John’s Wort. Caution: Alcohol, aspirin, NSAIDs, cimetidine, other drugs and remedies (see SPC). A Bleeding, purpura, ecchymosis, rashes.
ZIBOR
Helsinn Birex
2NO Antithrombotic. Bemiparin Na+ 2500 IU anti Factor Xa/0.2ml, 3500 IU anti Factor Xa/0.2ml. Soln for inj. in pre-filled syringe. 10 syringes/pack. 2500 IU, A17.72; 3500 IU, A30.23. S Prevention of thromboembolic disease in patients undergoing general and orthopaedic surgery. Prevention of clotting in the extracorporeal circuit during haemodialysis. P General surgery: Admin. 2,500 IU by SC inj., 2 hours before or 6 hours after surgery. On subsequent days admin. 2,500 IU by SC inj. every 24 hours for at least 7-10 days. Orthopaedic surgery: Admin. 3,500 IU by SC inj., 2 hours before or 6 hours after surgery. On subsequent days admin. 3,500 IU by SC inj. every 24 hours for at least 7-10 days. Prevention of clotting in the extracorporeal circuit during haemodialysis (R4 hours): Single bolus inj. into the arterial line at the beginning of the dialysis session. Patients R60kg: 2,500 IU, patients r60kg: 3,500 IU. Q Not recommended.
2NO ALSO ZIBOR 25000 Bemiparin Na+ 25000 IU anti Factor Xa/ml. 10 syringes/per pack. 5000 IU/0.2ml, A60.39; 7500 IU/0.3ml, A80.82; 10000 IU/0.4ml, A108.75. S Treatment of established deep vein
thrombosis, with or without pulmonary embolism, during the acute phase. P DVT: Admin. 25,000 IU by the SC route at a dose of 115 IU anti-Xa/kg weight, once daily. Duration of treatment: 7 +/- 2 days. Commence oral anticoagulation after 3-5 days and adjust dose to keep INR value between 2-3 times the control value. Stop Bemiparin admin. as soon as the said INR value achieved. Continue oral anticoagulation for at least 3 months. Q Not recommended. D Hypersensitivity to heparin or substances derived from pigs. Heparin induced thrombocytopenia (or history of). Active haemorrhage or increased risk of bleeding. Severe liver/pancreas impairment. Injuries to and operations on the CNS, eyes and ears. Disseminated Intravascular Coagulation (DIC). Acute bacterial endocarditis and endocarditis lenta. Organic lesion with high risk of bleeding. Lactation. B Do not admin. by IM and avoid IM injection of other agents. Liver/renal failure, uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis and/or urethrolithiasis, choroid and retinal vascular disease, or any other organic lesion with an increased risk of bleeding complications. Patients undergoing spinal or epidural anaesthesia and/or lumbar puncture (prophylactic use of heparin may very rarely be associated with epidural or spinal haematoma). May cause hyperkalaemia, particularly in at risk patients. In rare cases antibody-mediated severe thrombocytopenia has been observed. Perform platelet counts before admin., day 1, regularly thereafter (3-4 days) and at the end of therapy. Cutaneous necrosis, has been reported (discontinue immediately if occurs). Pregnancy. C Not recommended: Vitamin K antagonists and other anticoagulants, acetyl salicylic acid and other salicylates, NSAIDs, ticlopidine, clopidogrel and other platelet inhibitors systemic glucocorticoids and dextran. Products that increase the serum potassium (use under careful medical supervision). Intravenous nitroglycerine. A Ecchymosis at inj. site, haematoma and pain at injection site, bleeding complications, mild and transient elevations of ASAT, ALAT and gamma-GT levels.
2.7 HAEMORRHAGE
BENEFIX 2JN
patients post-operatively, neonates, or patients at risk of thrombotic phenomena or DIC. If agglutination of RBCs in the tubing/syringe occurs, discard and resume with new package. Use for immune tolerance induction (safety and efficacy has not been demonstrated). Pregnancy, lactation (only if clearly indicated).
CYKLOKAPRON
Meda
2MO Antifibrinolytic. Tranexamic acid 500mg. White oblong scored film-ctd tab. marked CY. 60, A15.04. S Short term use in haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Bleeding from local fibrinolysis e.g. menorrhagia, epistaxis, dental extractions in haemophiliacs. P Menorrhagia: 2-3 tabs. 3-4 times daily for 3-4 days. For other indications See SPC. Q 25mg/kg/dose. D Thromboembolic disease. B Early pregnancy. Impaired renal function. Haematuria in haemophilia. History of thromboembolic disease. Perform regular eye tests in patients with angioneurotic oedema. Rapid IV infusion may cause dizziness and/or hypertension. A GI upset. Colour vision disturbance.
CYKLOKAPRON INJECTION
Pfizer
2NO
Antifibrinolytic. Tranexamic acid 100mg/ml; 500mg/5ml. Soln for inj or inf. 10 x 5ml amp, A15.67; 30 x 5ml amp, A18.10. S Short term management of haemorrhage or risk of haemorrhage in increased fibrinolysis of fibrinogenolysis. Haemorrhage complications associated with: 1) Thrombolytic therapy. 2) disseminated intravascular coagulation (DIC) with predominant activation of fibrinolytic system. P Upper GI haemorrhage: 1g by IV inj 6 hourly for 3 days, then 1-1.5g orally 6 hourly for 3-4 days. Prostatectomey: 1g by IV inf. 8 hourly for 3 days; then 1g 3-4 times daily until macroscopic haematuria no longer present. Neutralisation of thrombolytic therapy: 10mg/kg by IV inj. DIC: See SPC. Renal Impairment: Reduce dose, see SPC. Q 25mg/kg/dose. D Thromboembolic disease, subarachnoid haemorrhage. B Caution: Haematuria of the urinary tract. Patients with high risk of thrombosis. Wyeth Pregnancy (unless essential), lactation. A Nausea, vomiting, diarrhea.
Recombinant coagulation factor IX. Nonacog alfa with antihaemophilic factor activities of 250 IU, 500 IU, 1000 IU Powder and solvent for soln for inj. 250 IU-1; 500 IU-1; 1000 IU-1. Price on request. S Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency). V Admin. by IV inf. according to severity of factor IX deficiency, the location and extent of bleeding, and patient’s clinical condition. See SPC for dose calculations. B Monitor for factor IX inhibitors in previously treated patients and patients experiencing allergic reactions. Potentially lifethreatening anaphylactic/anaphylactoid reactions may occur. Monitor patients with major factor IX gene deletion mutations. Admin. initial inf. under medical observation. Risk of thrombotic complications: Monitor patients with liver disease,
DDAVP DESMOPRESSIN
Ferring
2JN Vasopressin analogue. Desmopressin acetate 4mcg/ ml. Amp. 10 x 1ml, A134.12. S In the control of bleeding in patients with mild to moderate haemophilia and von Willebrand’s disease undergoing surgery or following trauma. V 0.4mcg/kg body weight by IV inf. Dose should be diluted in 50ml of 0.9% sodium chloride for inj. and given over 20 mins. immediately prior to surgery or following trauma. Further doses may be admin. at 12 hour intervals, as long as cover is PRESCRIBING NOTES INFUSIONS Intravenous infusions are prohibited except for those legitimately received in the course of hospital admissions or clinical investigations.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
73
2.8 HYPERCHOLESTEROLAEMIA -
CIRCULATORY SYSTEM
LIPIDAEMIC
platelet count r 50 x 109/l. Assess weekly until stable (r 50 x 109/l for at least 4 weeks without dose adjustment) then monthly thereafter. Max. 10mcg/kg once weekly. Dose adjustment: See SPC. D Pregnancy (unless clearly necessary). Lactation (assess risk/benefit). B Renal / hepatic impairment, elderly. Increased risk of bleeding upon discontinuation. Increased bone marrow reticulin (assess morphological changes in blood cells). Do not use for treatment of thrombocytopenia due to MDS or any other cause other than ITP. Theoretical risk for thrombotic/ thromboembolic complications and loss of response to romiplostim. Alterations in blood cell parameters. C Caution: Other drugs for treatment of KOGENATE BAYER Bayer Schering ITP (monitor), corticosteroids, danazol, and azathioprine. 2N Recombinant coagulation Factor VIII (rDNA) (bhk). A Headache, dizziness, paraesthesia, Octocog alfa with antihaemophilic factor activities migraine, GI disorders, skin disorders, pulmonary embolism, flushing, insomnia. Bone marrow of 250 IU, 500 IU, 1000 IU. Powder in single-dose vial with self contained, needle-less reconstitution disorders, thrombocytopenia. Arthralgia, myalgia, pain (extremity, back, bone), muscle spasm. device (BIO-SET). 250 IU-1, A272.50; 500 IU-1, Fatigue, inj. site reactions, oedema peripheral, A545.00; 1000 IU-1, A1090.00. influenza like illness, pain, asthenia, pyrexia, chills, S Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital Factor contusion. VIII deficiency). 2.8 HYPERCHOLESTEROLAEMIA V Admin. by IV inj (max 2ml/min) or by continuous inf. according to body weight, severity LIPIDAEMIC of disorder, site and extent of bleeding, titre of BELLPRAV Ranbaxy inhibitors and factor VIII level desired. See SPC. 2MO D Hypersensitivity to mouse or hamster protein. As Kogenate does not contain von Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Dark Willebrand Factor, not for use in von Willebrand yellow to yellow coloured mottled, circular, disease. biconvex tabs. marked with P1, P2 and P3 resp. on B Hypersensitivity and anaphylactic shock. one side. 20mg and 40mg with breakline on Monitor for the formation of neutralising reverse. 10mg-30, A13.03; 20mg-30, A25.13; antibodies to factor VIII. Pregnancy, lactation (only 40mg-30, A31.54. if clearly indicated). S Primary hypercholesterolemia (HC) or mixed dyslipidaemia, as adjunct to diet, when KONAKION Roche response to diet inadequate. Moderate or severe 2NO HC in patients at high risk of 1rst cardiovascular Vit. K deriv. Phytomenadione 10mg/ml. Amps. 10, event, as adjunct to diet. History of MI or unstable A4.76. angina pectoris with either normal or increased cholesterol levels as an adjunct to correction of S Treatment of haemorrhage. P 10-20mg as required. other risk factors. Post transplantation 2NO hyperlipidaemia in patients receiving immunossuppressive therapy following solid organ ALSO KONAKION MM PAED. Phytomenadione transplantation. 2mg per 0.2ml in mixed micelles. Amp. 5, A5.41. P HC: 10-40mg once daily preferably in S Prophylaxis and treatment of the evening. Full effect within 4 weeks. Max. haemorrhagic disease of the new born. Q Prophylaxis: initially 2mg orally at birth, 40mg daily. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg a day; can be then 2mg at 4-7 days. In exclusively breast-fed babies a further 2mg oral dose should be given at adjusted up to 40mg. Significant hepatic/renal impairment: Initially 10mg daily. 1 month. Monthly 2mg oral doses are advised until formula fed. Treatment: initially 1mg IV and Q Under 18 years, not recommended. further doses as required; see SPC. Preterm and D Pregnancy, lactation. Active liver special risk neonates; see SPC. disease. A Anaphylactoid reactions may occur with B Renal/hepatic impairment, inj. Flushes, sweating, cyanosis. hypothyroidism, history of hereditary muscular disorders, alcohol abuse, elderly q70. Discontinue NPLATE Amgen if liver enzymes q3x ULN. Risk of myalgia/ myopathy; monitor creatine kinase (CK) if ;JM predisposing factors or if symptoms occur Antihemorrhagic. Romiplostim 250mcg. Powder (interrupt if CK levels q 5xULN). Contains lactose. for sln for inj. in vial. A708.82. C Fibrates (avoid). Bile acid-binding resin S Adult chronic immune (idiopathic) eg. cholestyramine, colestipol (take 1 hr before or thrombocytopenic purpura (ITP) splenectomised 4 hrs after resin). Caution: Ciclosporin, patients who are refractory to other treatments (e.g. corticosteroids, Igs). Second line treatment for erythromycin, clarithromycin, nicotinic acid. adult non-splenectomised patients where surgery BYSTAT Helsinn Birex is contraindicated. P Once weekly as SC inj. Initially, 1mcg/kg 2 M O Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink, body weight. Vol. inj. (ml): Dose in mcg x 1ml/ light yellow, light green tabs. marked 771, 7201, 500mcg. Increase by increments of 1mcg/kg until
required. D Habitual and psychogenic polydipsia, unstable angina pectoris, decompensated cardiac insufficiency, von Willebrandâ&#x20AC;&#x2122;s disease Type IIB. B Renal impairment, CVD, fluid and/or electrolyte imbalance, cystic firbosis. Pregnancy. Avoid fluid overload. C Indomethacin, NSAIDs, substances suspected to induce SIADH (e.g. TCAs, SSRIs, chlorpromazine, carbamazepine). A Headache, stomach pain and nausea, fluid retention/hyponatraemia with accompanying symptoms (headache, nausea, vomiting, weight gain, decreased serum Na+ and in serious cases, convulsions).
74
7202 resp. on one side. All round shallow convex, marked 93 on reverse. 10mg-30, A7.80; 20mg-30, 40mg-30, A18.76. S Primary hypercholesterolemia (HC) or mixed dyslipidaemia, as adjunct to diet, when response to diet inadequate. Moderate or severe HC in patients at high risk of 1rst cardiovascular event, as adjunct to diet. History of MI or unstable angina pectoris in patients with normal or increased cholesterol levels, as adjunct to correction of other risk factors. Post transplantation hyperlipidaemia in patients receiving immunossuppressive therapy following solid organ transplantation. P HC: 10-40mg once daily preferably in the evening. Full effect within 4 weeks. Max. 40 mg daily. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg a day; can be adjusted up to 40mg. Q Heterozygous familial HC: 8-13 years, 10-20mg once daily; 14-18 years, 10-40mg daily. D Pregnancy and lactation. Active liver disease. B Renal/hepatic impairment, hypothyroidism, history of hereditary muscular disorders or liver disease, alcohol abuse, children before puberty. Discontinue if liver enzymes q3x ULN. Risk of myalgia/myopathy; monitor creatine kinase (CK) if predisposing factors or if symptoms occur (discontinue if CK levels q 5xULN). Contains lactose. C Fibrates (avoid). Caution: Cholestyramine (take 1 hr before or 4 hrs after resin), colestipol, cyclosporin, erythromycin, clarithromycin, nicotinic acid. A14.99;
CRESTOR
AstraZeneca
2NO Statin. Rosuvastatin (Ca++) 5mg, 10mg, 20mg, 40mg. Film-ctd tabs. marked ZD 4522 and strength. 5mg, round yellow. 10mg, 20mg, round pink. 40mg, oval pink. 5mg-28, A18.22; 10mg-28, A22.41; 20mg-28, A36.56; 40mg-28, A37.56. S Primary hypercholesterolaemia (HC) incl. heterozygous familial HC, homozygous familial HC, or mixed dyslipidaemia in patients unresponsive to diet and other nonpharmacological measures. P Initially 5mg or 10mg once daily (incl. patients switched from other statins). Starting dose of 5mg recommended for: Patients q70 years, moderate renal impairment, Asian ancestry, predisposing factors to myopathy. If necessary, increase to next dose level after 4 weeks. Max. 40mg daily (only in severe HC at high cardiovascular risk, under specialist supervision). Q Not recommended. D Active liver disease or unexplained persistent elevation in serum transaminases, severe renal impairment, myopathy. Pregnancy, lactation. Women of childbearing potential not using contraception. 40mg dose: Pre-disposing factors for myopathy/ rhabdomyolysis (eg. moderate renal impairment, hypothyroidism, history of hereditary muscular disorders, alcohol abuse, Asian patients, concomitant fibrates). B History of liver disease, alcoholism, predisposing factors for myopathy/rhabdomyolysis; caution. Perform liver function tests prior to and 3
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM
HYPERCHOLESTEROLAEMIA -
B Increased risk of myopathy. Measure CK level before starting treatment in: Elderly (q70 years), renal impairment, uncontrolled hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity with a statin or fibrate, alcohol abuse. If CK levels q5xULN, do not start treatment. If muscular symptoms occur measure CK levels and discontinue if found q5xULN. If muscular symptoms severe even if CK levels Q5xULN, consider discontinuation. Moderate or severe hepatic insufficiency (not recommended). Severe renal insufficiency (caution). EZETROL MSD-SP Ltd C Potent CYP3A4 inhibitors (contraindicated), fibrates, amiodarone or 2MO Cholesterol absorption inhibitor. Ezetimibe 10mg. verapamil, grapefruit juice. Caution: Ciclosporin, danazol, gemfibrozil, niacin, diltiazem, White cap.-shaped tabs. marked 414 on one side. cholestyramine, fusidic acid, coumarin 28, A33.60 anticoagulants, fluindione. S Adjunctive therapy to diet for: Primary A GI disorders, headache, myalgia, fatigue. (heterozygous familial and non-familial) hypercholesterolaemia, as combination therapy Novartis with statin where statin alone is ineffective, or as LESCOL XL 2MO monotherapy where statin is inappropriate; homozygous familial hypercholesterolaemia as Statin. Fluvastatin (as Na+) 80mg. Yellow combination therapy with statin with or without prolonged release tab. marked LE one side, NVR on reverse. 28 (Cal/Pk), A10.91. adjunctive treatments (e.g. LDL apheresis); 2MO homozygous sitosterolaemia (phytosterolaemia). P 10mg daily with or without food. CoALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. admin. with statin: Use usual initial statin dose, or Brown/yellow caps. marked with XU, strength and continue established higher statin dose. company logo. 20mg-28 (Cal/Pk), A14.55; 40mg-28 Q 10 years or under, not recommended. (Cal/Pk). A17.16; 40mg-56 (Cal/Pk), A32.15. D When co-admin. with statin: Pregnancy, S Adjunct to diet for the reduction of lactation, active liver disease or unexplained elevated total and LDL cholesterol in patients with persistent elevations in serum transaminases. primary hypercholesterolaemia (HC) and mixed B Moderate or severe liver dysfunction dyslipidaemia (Frederickson Types IIa and IIb). (not recommended). Perform liver function tests P 40mg or 80mg once daily at night when starting co-admin. with statin. Monitor for swallowed whole with water with or after meal. signs of myopathy. Lactation (not recommended), Titrate to lowest effective dose at 4-week pregnancy (no data). Contain lactose. intervals. Range, 20-80mg. C Fibrates, possible risk of cholelithiasis Q Over 9 years with familial HC: Initially and gallbladder disease. Caution: Ciclosporin, 40mg once daily; titrate to 80mg if necessary; coumarin anticoagulants or fluindione (monitor 20mg may be adequate in mild cases. Under 9 International Normalised Ratio). Bile acid years: Not recommended. sequestrant (e.g. cholestyramine), admin. at least 4 D Active liver disease or persistent hrs before or 2 hrs after ezetimibe. unexplained elevation of transaminase levels, A Headache, GI disorders. Also fatigue cholestasis. Myopathic disorders. Caution if history and myalgia when co-admin. with statin. of liver disease, high alcohol consumption. Pregnancy, lactation. INEGY MSD-SP Ltd B Monitor serum transaminase levels before and periodically during treatment. Severe 2MO renal impairment. Unexplained diffuse myalgias, Cholesterol absorption inhibitor/statin. Ezetimibe muscle tenderness, muscle weakness and/or 10mg and simvastatin 20mg, 40mg, 80mg. White to off-white cap.-shaped tab. with code 312, 313, marked elevated creatine phosphokinase (CPK) or 315. 10/20mg-28, A42.00; 10/40mg-28, A49.00; values due to myopathy, myositis or rhabdomyolysis; discontinue. 10/80mg-28, A51.80. S As adjunctive therapy to diet in primary C Cholestyramine (admin. min. 4 hrs before Lescol). Caution: Rifampicin, warfarin, hypercholesterolaemia (HC) or mixed immunosuppressants (incl. cyclosporin), hyperlipidaemia in patients not appropriately gemfibrozil, nicotinic acid, erythromycin, controlled with a statin alone, or already treated glibenclamide. with a statin and ezetimibe. A Dyspepsia, abdominal pain, nausea, P 10/20mg/day or 10/40mg/day as single insomnia, headache. dose in the evening. 10/80mg dose only
months after start of treatment. Reduce doses or discontinue if levels of serum transaminases q 3 x upper limit of normal. Monitor renal function with 40mg dose. Stevens-Johnson syndrome has been reported. Contains lactose. C Contra: Cyclosporin. Not recommended: Protease inhibitors. Gemfibrozil, other lipidlowering agents, vit. K antagonists, antacids, erythromycin, oral contraceptives, HRT. 40mg dose: Fibrates (contra). A Headache, dizziness, constipation, nausea, abdominal pain, myalgia, asthenia.
recommended in severe HC and high risk for cardiovascular complications. Make any adjustments at min. 4-week intervals. Homozygous Familial HC: 10/40mg/day or 10/80mg/day in the evening. May be used as adjunct to other lipidlowering treatments (e.g., LDL apheresis). Coadmin. with other drugs: See SPC. Q Children and adolescents, not recommended. D Pregnancy and lactation. Liver disease or unexplained persistent elevations in serum transaminases.
LIPIDAEMIC
2.8
phototoxic reactions with fibrates or ketoprofen. Pregnancy, lactation. B Renal impairment. Monitor serum transaminase every 3 months during first 12 months of treatment. Pancreatitis has been reported. Patients with pre-disposing factors for rhabdomyolysis. Discontinue if muscle toxicity occurs. Hyperlipidaemic patients taking oestrogens, determine if primary or secondary hyperlipidaemia. C Caution: Anti-coagulants, cyclosporin, HMG-CoA reductase inhibitors or other fibrates. A GI upset, skin reactions, headache, fatigue, vertigo,
LIPANTIL SUPRA
Solvay
2MO Fibrate. Fenofibrate (nanoparticles) 145mg. White, oblong, film-ctd tab. engraved 145 on one side and Fournier logo on the other. 30, A19.50. S Hypercholesterolaemia and hypertriglyceridaemia alone or combined in patients unresponsive to dietary and other nondrug therapeutic measures, particularly when evidence of associated risk e.g. hypertension, smoking. Secondary hyperlipoproteinaemias, if hyperlipoproteinaemia persists despite effective treatment of underlying disease. Appropriate dietary measures initiated before therapy should be continued. P 1 tab, once daily, swallowed whole with water. Renal impairment: Lower dose recommended, 100mg or 67mg. Q Contra. D Hepatic/renal insufficiency, children, known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, gallbladder disease. Peanut, arachis oil, soya allergy. Pregnancy, lactation. B Treat secondary cause of hypercholesterolemia before initiating therapy. Hyperlipidaemic patients taking oestrogens, determine if primary or secondary hyperlipidaemia. Monitor transaminase levels every 3 months for 1st year. Pancreatitis, reported. Risk of muscle toxicity (discontinue). Pre-disposing factors for myopathy/rhabdomyolysis. Monitor renal function for first 3 months and interrupt if cc increases q 50%. Contains lactose, sucrose. C Oral anticoagulants, not recommended. Caution: Cyclosporin, HMG-A reductase inhibitors, other fibrates. A GI disorders, moderately elevated levels of serum transaminases.
LIPAPRAV
Gerard
2MO
Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pinkpeach (10mg), yellow (20mg, 40mg) indented cap.shape, film-ctd tablets with either 10, 20 or 40 on one side. 10mg-28, A12.10; 20mg-28, A23.99; 40mg-28, A29.99. S Primary hypercholesterolemia (HC) or LIPANTIL MICRO Solvay mixed dyslipidaemia, as adjunct to diet, when 2MO response to diet and other non-pharmacological Fibrate. Fenofibrate (micronised) 200mg, 67mg. treatments is inadequate. Moderate or severe HC Orange cap. and yellow cap. resp. 200mg-30, in patients at high risk of a 1rst cardiovascular A18.32; 67mg-90,A18.85. event, as adjunct to diet. History of MI or unstable angina pectoris with either normal or increased S Hyperlipidaemia resistant to diet. cholesterol levels, as adjunct to correction of other P 3 x 67mg daily in divided doses or 1 x risk factors. Post transplantation hyperlipidaemia 200mg daily with food. in patients receiving immunossupressive therapy Q Not recommended. D Severe renal or hepatic dysfunction, gall following solid organ transplantation. P Taken once daily, preferably the bladder disease, biliary cirrhosis. Photoallergy or
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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2.8 HYPERCHOLESTEROLAEMIA -
CIRCULATORY SYSTEM
LIPIDAEMIC
40mg-28, A17.99. S Primary hypercholesterolaemia (HC)or mixed dyslipidaemia, as adjunct to diet where response to diet and other non-pharmacological measures has been inadequate. Adjunct to diet to prevent cardiac events in patients with HC and at high risk. Adjunct to correction of other risk factors in patients with history of MI or unstable angina regardless of cholesterol levels. Reduction of post transplantation hyperlipidaemia in patients receiving immunosuppressive therapy. P HC: Usual range, 10-40mg once daily at bedtime. Full effect within 4 weeks. Cardiovascular prevention: 40mg daily. Post transplantation: Initially 20mg daily; max. 40mg daily. Renal/ hepatic impairment: Initially 10mg daily. Q Heterozygous familial HC: 8-13 years, 10-20mg once daily; 14-18 years, 10-40mg daily. D Active liver disease. Pregnancy, lactation. B Hepatic disease. Withdraw if ALT and AST q3xULN and persist. Measure CK prior to therapy in patients at risk of myopathy. Monitor for signs of myopathy (interrupt if severe symptoms or CKq5xULN). Children before puberty (evaluate benefit/risk). Dizziness and visual disturbances may occur. LIPITOR Pfizer C Fibrates (avoid). Take 1 hr before or 4 hrs after cholestyramine or colestipol. Caution: 2MO Cyclosporin, erythromycin, clarithromycin. Statin. Atorvastatin 10mg, 20mg, 40mg, 80mg. A Uncommon. White elliptical film-ctd tabs. marked with code and tab. strength. 10mg-28, A21.39; 20mg-28, LOCHOL Clonmel A33.74; 40mg-28, A56.43; 80mg-28, A65.09. 2MO S Adjunct to diet in primary Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 hypercholesterolaemia, heterozygous familial hard cap. with blue or green cap and white body. hypercholesterolaemia, mixed hyperlipidaemia. 20mg-28, A7.56; 40mg-28, A8.92. Homozygous familial hypercholesterolaemia as S Primary hypercholesterolaemia and adjunct to other lipid-lowering treatments or if mixed dyslipidaemia (Fredrickson Types IIa and IIb) such treatments are unavailable. Raises HDLas adjunct to diet to reduce elevated total cholesterol and lowers LDL/HDL and total cholesterol and low-density lipoprotein cholesterol cholesterol/HDL ratios. Prevention of when response to diet and other noncardiovascular events in patients estimated to have pharmacological treatments is inadequate. a high risk for a first cardiovascular event, as P Before treatment start cholesteroladjunct to correction of other risk factors. lowering diet and continue during treatment. P Initially 10mg once daily, increase as Initially 20mg to 40mg daily. May be increased to necessary at 4 week intervals; max. 80mg once 80mg (max). Max lipid-lowering effect is achieved daily. within 4 weeks. Q Severe dyslipidaemias in 4-17 years: Q Under 18 years, not recommended. 10mg per day. May be increased to 80mg daily. D Active liver disease, or unexplained, No developmental safety data available. persistent elevations in serum transaminases. D Active liver disease, persistent raised Pregnancy, lactation. liver enzymes (q 3xULN), myopathy. Pregnancy, B Monitor liver function before and lactation. Ensure adequate contraception. periodically during treatment; discontinue if B History of alcohol abuse or liver disease. increase in AST or ALT exceeds 3 x ULN and Perform liver function tests before treatment, at persists. Caution: History of liver disease, heavy 12 weeks or elevation of dose and periodically alcohol consumption. Caution (measure CK levels thereafter. Myalgia, myopathy, and very rarely before starting treatment): Renal impairment, rhabdomyolysis have been reported. Patients with hypothyroidism, personal or familial history of pre-disposing factors for rhabdomyolysis; monitor hereditary muscular disorders, previous history of CPK before therapy, see SPC. Contains lactose. muscular toxicity with a statin or fibrate, alcohol C Cyclosporin, fibrates, macrolide abuse, elderly (if other predisposing factors antibiotics, azole antifungals, niacin, drugs present). May occur: Myopathy (rarely), myositis metabolised by cytochrome P450 3A4, digoxin, and rhabdomyolysis (very rarely); advise patients erythromycin, oral contraceptives, colestipol, to promptly report if occur; stop treatment if CK antacids, warfarin, protease inhibitors. levels q5 x ULN. If symptoms are severe and cause A GI disturbances, headache, myalgia, daily discomfort, consider discontinuation even if asthenia, insomnia. Elevated serum transaminases CK levels Q5 x ULN. Homozygous familial and CPK levels. hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, LIPOSTAT BMS ciclosporin, warfarin and other coumarin 2MO derivatives, rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile Statin. Pravastatin (as Na+ salt) 10mg, 20mg, 40mg. Lemon oval scored tabs. marked 10, 20 and acid sequestrants (e.g. cholestyramine; admin. fluvastatin at least 4 hrs after), fluconazole, 40 resp. 10mg-28, A7.49; 20mg-28 , A14.40;
evening. HC: 10-40mg. Full effect within 4 weeks. Cardiovascular prevention: 40mg. After transplantation: Initially 20mg, may be adjusted to 40mg depending on lipid parameters. Moderate/ severe renal impairment, significant hepatic impairment: Initially 10mg daily. Q Heterozygous familial HC: 8-13 years, 10-20mg; 14-18 years, 10-40mg. D Active liver disease including unexplained persistent elevations of serum transaminase (q3xULN). Pregnancy, lactation. B Not evaluated for homozygous familial HC. Not suitable for elevated HDL-cholesterol. Discontinue if liver enzymes q3xULN. Caution: History of liver disease, heavy alcohol ingestion. May occur: Myalgia, rhabdomyolysis, myopathy; monitor creatinine kinase (CK) if predisposing factors, see SPC. C Avoid: Fibrates; if necessary, monitor CK. Caution: Erythromycin, clarithromycin, cyclosporin. Cholestyramine/colestipol: Take pravastatin 1 hr before or at least 4 hrs after.
76
phenytoin. A Insomnia, headache, fatigue, dizziness, GI disorders, arthralgia.
LOPID
Pfizer
2MO Fibrate. Gemfibrozil 300mg. White/maroon cap. marked Lopid 300. 112, A31.93.
2MO ALSO LOPID TABLETS 600MG Gemfibrozil 600mg. White elliptical film-ctd scored tab. marked LOPID on one side. 56, A31.93. S As adjunct to diet and exercise in: Mixed dyslipidaemia; primary hypercholesterolaemia, particularly when a statin is inappropriate/not tolerated; reduction of cardiovascular morbidity in males with increased non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is inappropriate/not tolerated. P Usually 600mg twice daily, although 900mg daily may be sufficient. Mild-moderate renal impairment: Start treatment at 900mg daily. Q Not recommended. D Hepatic dysfunction, severe renal impairment, pre-existing gall bladder or biliary tract disease, incl. gallstones. History of photoallergy or phototoxic reaction during treatment with fibrates. Pregnancy, lactation. B Myositis, myopathy and elevated CPK have been reported. Rhabdomyolysis has been reported rarely. Measure CPK levels before combination with statins in patients with predisposing factors for rhabdomyolysis. Perform lipid profile, blood count and liver functon tests before treatment. Check blood count every 2 months during first 12 months of treatment. Monitor serum lipids periodically. Discontinue if persistent liver function abnormality. C Contraindicated: Repaglinide. Avoid statins. Caution: Rosiglitazone, oral anticoagulants. Bexarotene, not recommended. Admin. resingranule drugs e.g. colestipol 2 hours apart. A Vertigo, headache, GI disorders, eczema, rash, fatigue.
LUVINSTA
Actavis
2MO Statin. Fluvastatin (as Na+) 20mg, 40mg. Resp. orange/ivory or orange/yellow opaque hard cap. marked with FST and strength. 20mg-28, A10.93; 40mg-28, A12.89. S Primary hypercholesterolaemia and mixed hyperlipidaemia (Fredrickson Types IIa and IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments is inadequate. P Initially 20mg to 40mg daily in the evening. May be increased to 80mg (max). Q 40 mg once or twice daily. 20mg may be adequate in mild cases. D Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy, lactation. B Monitor liver function before and periodically during treatment; discontinue if increase in AST or ALT q 3 x ULN persists. Caution: History of liver disease, heavy alcohol consumption, pre-disposing factors for rhabdomyolysis (measure CK levels before starting treatment). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur. Discontinue if interstitial lung disease occurs. Homozygous
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
I can’t imagine doing anything else. Three generations of my family, it’s in the blood. When waves are 10 times bigger than the boat you hold on a bit tighter. Never underestimate the sea.
Abbreviated prescribing information: Lipitor¡ Presentation: Lipitor is supplied as film-coated tablets of 10, 20, 40 or 80mg of atorvastatin. Indications: Hypercholesterolaemia: As an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults with primary hypercholesterolaemia, including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (corresponding to types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Also indicated to reduce total cholesterol and LDL cholesterol in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios. Prevention of Cardiovascular Disease: Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. Dosage: The usual starting dose is one Lipitor 10mg tablet daily. Doses should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. Doses may be given at any time of the day with or without food. The maximum daily dose is 80mg once daily. Current consensus guidelines should be consulted to establish treatment goals for individual patients. Contraindications: Hypersensitivity to any of the ingredients, active liver disease, unexplained persistent elevations in serum transaminases exceeding 3-times the upper limit of normal, myopathy, pregnancy, breast-feeding and in women of child-bearing potential not using contraception. Warning and precautions: Liver function tests should be performed before initiation, 12 weeks after initiation or a dose increase and periodically LIP/2009/034 thereafter as well as in patients who show signs Lipitor is manufactured in Ireland
and symptoms of liver injury (monitor raised transaminases until they return to normal). Drug dosage should be reduced or therapy discontinued if persistent elevations occur above 3-times the upper limit of normal. Lipitor should be used with caution in patients with a history of liver disease and/or alcoholism. Statin treatment has been associated with the onset of myalgia, myopathy, and very rarely rhabdomyolysis. Myopathy must be considered in patients presenting with unexplained muscle symptoms and in such cases creatine phosphokinase (CPK) levels should be measured. Lipitor should be discontinued if CPK levels are markedly or persistently raised or myopathy is diagnosed or suspected. Lipitor should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis. Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medications that may increase the plasma concentration of atorvastatin. If possible alternative (non-interacting) therapies should be considered. If co-administration of such medications with atorvastatin is necessary, the benefit and the risk of concurrent treatment should be carefully considered, and a lower starting dose of atorvastatin is recommended. In the case of ciclosporin, clarithromycin and itraconazole, a lower maximum dose of atorvastatin should be considered. For concomitant use of clarithromycin or itraconazole with atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped until the clarithromycin/itraconazole treatment course is completed and CPK has returned to baseline values. Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in postmarketing experience with this combination – therefore patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate. As with other drugs in this class, rhabdomyolysis with acute renal failure, has been reported. For patients with prior haemorrhagic stroke or lacunar infarct, the balance of risks and benefits of atorvastatin 80 mg is
uncertain and the potential risk of haemorrhagic stroke should be carefully considered before initiating treatment. Patients with rare hereditary problems of galactose intolerance, the Lapp Lactase deficiency or glucose-galactose malabsorption should not take this medication. Pregnancy and lactation: Lipitor is contraindicated in pregnancy and lactation. A 1 month interval should be allowed from stopping treatment to conception if pregnancy is planned. Side effects: Side effects most frequently reported in controlled clinical studies: constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, asthenia, diarrhoea, insomnia, elevations in serum transaminases and CPK levels. Other side effects have been reported in clinical trials and for post marketing surveillance: (See Summary of Product Characteristics). Legal category: S1A. Date of revision: December 2008. Package quantities and marketing authorisation numbers: Lipitor 10mg (28 tablets), PA841/1/1; Lipitor 20mg (28 tablets), PA841/1/2; Lipitor 40mg (28 tablets), PA841/1/3; Lipitor 80mg (28 tablets), PA841/1/4. Marketing Authorisation Holder: Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin, Ireland. Lipitor is a registered trade mark. Further information is available on request from: Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, United Kingdom. Company Reference LR7_0. Date of Preparation: July 2009.
My life.
Your decision.
2.8 HYPERCHOLESTEROLAEMIA -
CIRCULATORY SYSTEM
LIPIDAEMIC
dyslipidaemia as adjunct to diet when inadequate response to diet. Moderate or severe HC in patients at high risk of cardiovascular events as Polyunsaturated fatty acid. Omega-3-acid ethyl adjunct to diet. History of MI or unstable angina esters 1000mg (including EPA and DHA 840 mg). pectoris regardless of cholesterol levels. Post Soft, oblong, transparent gelatin caps. containing transplantation hyperlipidaemia in patients pale yellow oil. 28, A17.56. receiving immunosuppressive therapy following S Endogenous hypertriglyceridaemia as solid organ transplantation. supplement to diet when dietary measures alone P HC: 10-40mg once daily preferably in are insufficient: Type IV in monotherapy; type IIb/ the evening. Response seen within a week and full III in combination with statins when control of effect within 4 weeks. Max. 40mg daily. Cardiovascular prevention: 40mg daily. After MAXEPA Seven Seas triglycerides is insufficient. P Initially, 2 daily with food; increase to 4 transplantation: Initially, 20mg daily; may be 2M if necessary. adjusted up to 40mg. Moderate/severe renal Polyunsaturated fatty acids. Eicosapentaenoic acid Q Not recommended. impairment, significant hepatic impairment: (EPA) 170mg, docosahexaenoic acid (DHA) 115mg. D Pregnancy, lactation (no data). Initially 10mg daily. Yellow oblong gelatin cap. marked Maxepa. 200, B Exogenous hypertriglyceridaemia (type 1 Q Heterozygous familial HC: 8-13 years, A39.97. hyperchylomicronaemia); not indicated. Hepatic 10-20mg once daily; 14-18 years, 10-40mg daily. S Reduction of plasma triglyceride levels impairment (monitor hepatic function, especially Evaluate benefit/risk in children before puberty. in patients with severe hypertriglyceridaemia who with high dosage). Patients at high risk of D Active liver disease incl. unexplained are at special risk of ischaemic heart disease and/ haemorrhage. Moderate increase in bleeding time persistent elevations of serum transaminase or pancreatitis. Use in conjunction with may occur with high dosage (i.e. 4 cap.) elevation (q3xULN). Pregnancy, lactation. appropriate dietary measures. C Oral anticoagulants (monitor and adjust B Caution: Renal impairment, P 5 twice daily with food. dose). hypothyroidism, previous history of muscular Q Not recommended. A GI disturbances. toxicity with a statin/fibrate, history of hereditary D Non-insulin dependent diabetic patients muscular disorders. Homozygous familial HC (not PRAVAMEL Clonmel studied). History of liver disease, heavy alcohol with aspirin sensitive asthma. B Monitor patients with bleeding ingestion. Increased transaminase levels; 2MO disorders Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink/ discontinue if q3xULN and persists. Monitor for C Anticoagulants, aspirin, cephalosporins. peach tab. marked 10. Yellow tab. marked 20. signs of myalgia, myopathy; interrupt if CK levels A Nausea, eructation. q5xULN or if severe symptoms. Dizziness when Yellow tab. marked 40. All cap. shaped film-ctd. driving vehicles or operating machines. Contains 10mg-30. A11.02; 20mg-30, A21.18; 40mg-30, NIASPAN Abbott A26.46. lactose. C Fibrates (avoid), bile acid-binding resins 2MO S Primary hypercholesterolaemia (HC) (admin. 1 hr before or min 4 hrs after resin). when response to diet and other nonNicotinic acid. Nicotinic acid 375mg, 500mg, Caution: Ciclosporin, erythromycin or pharmacological treatments is inadequate, 750mg, 1000mg. White to off-white cap.-shaped clarithromycin. moderate or severe HC in patients at high risk of tab. marked with strength on one side. 375mg-7, 1st cardiovascular event (as adjunct to diet). A4.19; 500mg-7, A5.58; 750mg-7, A8.38; 500mgPRAVITIN Rowex History of MI or unstable angina pectoris with 56, A21.24; 750mg-56, A33.65; 1000mg-56, normal or increased cholesterol levels (as adjunct 2MO A38.27. to other risk factor correction). Post transplant Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. S Dyslipidaemia, particularly combined hyperlipidaemia reduction in patients on Yellow, oval, convex, side wall scored tab. marked mixed dyslipidaemia, primary immunosuppressive therapy following solid organ P10, P20 or P40. 10mg-30, A13.38; 20mg-30, hypercholesterolaemia. In combination with transplantation. A25.67; 40mg-30, A32.12. statins, when statin monotherapy is inadequate. P HC: 10-40mg daily, preferably in the S Primary hypercholesterolaemia (HC) or As monotherapy only in patients who do not evening; max. 40mg daily. Cardiovascular mixed dyslipidaemia, as adjunct to diet when no tolerate statins. prevention: 40mg daily. After transplantation: response to dietary measures. Reduction of P (Week1) 375mg once daily, (week2) Initially, 20mg daily; may titrate up to 40mg. cardiovascular mortality and morbidity: a) patients titrate to 500mg, (week3) 750mg, (week 4-7) Moderate to severe renal impairment: Initially with moderate or severe HC and at high risk of 1000mg (two 500mg tabs.), all once daily at 10mg daily. cardiovascular event as adjunct to diet; b) patients bedtime after low-fat snack. Maintenance dose: Q Under 18 years, not recommended. with history of MI or unstable angina pectoris as 1000mg (two 500mg tabs.) or 1500mg (two 750mg D Active liver disease. Pregnancy, adjunct to correction of other risk factors. tabs.) or 2000mg (two1000mg tabs.), all once lactation. Reduction of post transplantation hyperlipidaemia daily. Do not increase by more than 500mg in any B Elevated serum transaminase and/or in patients receiving immunosuppressive therapy 4-week period after initial titration to 1000mg. creatine kinase levels (monitor). Renal impairment, following solid organ transplantation. Max., 2000mg per day. Tab. strengths not hypothyroidism, liver disease (history), heavy P HC: 10-40mg once daily preferably in interchangeable. alcohol ingestion. Risk of myopathy, myalgia. the evening. Full effect within 4 weeks. Adjust Q Children and adolescents, not C Fibrates, cholestyramine, colestipol, dosage according to periodic lipid determination. recommended. cyclosporin, erythromycin, clarithromycin. Max. daily dose, 40 mg. Cardiovascular prevention: D Significant hepatic dysfunction, active 40mg daily. Following organ transplantation: peptic ulcer disease, arterial bleeding. Pregnancy PRAVASTATIN SODIUM (INN) Initially 20mg a day; can be adjusted up to 40mg. (unless essential), lactation. Teva Renal or hepatic impairment: Initially, 10mg a day B Do not replace with other nicotinic acid and adjusted according to response of lipid preparations. Substantial alcohol intake, history of 2 M O parameters. Concomitant therapy: Lipid lowering Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. 10mg- effects enhanced when combined with bile acidliver disease. Monitor liver function. Combined A11.24; 20mg-28, A21.61; 40mg-28, A27.00. 28, therapy, monitor for signs of rhabdomyolysis. binding resin (1 hr before or at least 4 hrs after Diabetes, unstable angina, acute phase of MI, resin). Patients taking cyclosporin: Initially, 20mg Pinewood surgery. History of jaundice, hepatobiliary disease, PRAVAT once daily; titration to 40mg with caution. 2MO or peptic ulcer. May affect platelets count, uric Q Under 18 years, not recommended. + acid and P levels. Statin. Pravastatin (Na ) 10mg, 20mg, 40mg. Light D Pregnancy and lactation. Active liver C Alcohol. Caution: Anti-coagulants, pink, light yellow, light green tabs resp. All round, disease. ganglionic blocking agents (e.g. transdermal unscored, marked APO on one side and PRA over B Renal impairment, hypothyroidism, nicotine or vasoactive drugs), HMG-CoA reductase strength on reverse. 10mg-28, A12.45; 20mg-28, history of hereditary muscular disorders or liver A23.92; 40mg-28, A29.92. inhibitors. disease, alcohol abuse. Discontinue if: Liver enzymes q3x normal upper limit (ULN); CK levels A Flushing, GI disorders, rash, pruritus. S Hypercholesterolaemia (HC) or mixed familial hypercholesterolemia: Not recommended. C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin derivatives (monitor prothrombin times), rifampicin (long-term), glibenclamide (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (admin. fluvastatin at least 4 hrs after), fluconazole, phenytoin. A Headache, fatigue, dizziness, GI disorders, joint pain, insomnia.
78
OMACOR
Solvay
2MO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM q5x ULN or if myopathy suspected. C Fibrates. Caution: Cholestyramine, colestipol, cyclosporin, erythromycin, clarithromycin.
HYPERCHOLESTEROLAEMIA -
shaped, pink tab. 10mg-28, A13.75; 20mg-28, A23.39; 40mg-28, A23.39; 80mg-28, A23.39. S CHD: In patients with plasma cholesterol r5.5mmol/L. Hyperlipidaemia: Adjunct to diet for reduction of total and LDL-cholesterol, QUESTRAN BMS apolipoprotein B and triglycerides in patients with primary hypercholesterolaemia, combined 2MO hyperlipidaemia when response to diet is Bile acid sequestrant. Cholestyramine 4g. Powder inadequate. A in sachet. 50, 24.32. P CHD: Initially 20mg/day, adjusted if S Type II hyperlipoproteinaemias. P 12-24 g daily in divided doses; max. 36g necessary at intervals r 4 weeks, to max. of 40mg/day, or exceptionally 80mg/day. daily. Q Under 6 years, not recommended; over Hyperlipidaemia: Recommended dose, 10mg/day. Dose range, 10 to 80mg/day. In combination with 6 years, in proportion to dose for 70kg adult. ciclosporin, fibrates or niacin: Max. dose, 10mg/ D Complete biliary obstruction. B On long term, suppl. diet with vitamins day. Take all daily doses as single doses in the A, D and K. Pregnancy, lactation. Contain sucrose. evening. Standard cholesterol lowering diet recommended before and during treatment. C Digitalis, antibiotics, diuretics. Take all Reduce dosage if LDL-cholesterol levels fall below drugs 1 hour before or 4-6 hours after Questran. 1.96mmol/l or total serum cholesterol levels fall A Constipation. below 3.6mmol/l. Renal Insufficiency: Doses RITECHOL Niche q10mg/day, caution. Q Under 18 years, not recommended (no 2MO data). Statin. Simvastatin 10mg, 20mg, 40mg. Oval, tabs. D Active liver disease or unexplained marked 10 and 20 resp. on one side; round tab. persistent elevation of serum transaminase values. plain on one side (40mg). All white, film-coated Porphyria, myopathy. Pregnancy, lactation. with a breakline on the reverse. 10mg-28, A12.84; Women of child bearing age (unless adequate 20mg-28, A21.82; 40mg-28, A21.82. contraception used). S Hypercholesterolaemia: Adjunct to diet B Risk of myopathy. Monitor liver for reduction of elevated total and LDL-cholesterol function. Impaired renal function. Tabs. contain in patients with hypercholesterolaemia (type IIa) lactose. or combined hyperlipidaemia (type IIb) when C Ketoconazole, itraconazole and HIVresponse to diet and other non-pharmacological protease inhibitors, delaviradine, mibefradil. measures is inadequate. CHD: Secondary Caution: Gemfibrozil and other fibrates, niacin, prevention in patients with elevated plasma potent inhibitors of CYP3A4, telithromycin, cholesterol (q5.5mmol/L). coumarin anticoagulants, digoxin. Avoid P Hypercholesteroleamia: Initially 10mg grapefruit juice. once daily at night, adjusting at min. 4-week A GI disturbances. intervals according to response. Usual range 1040mg daily as a single dose at night. CHD: Initially SIMTAN Clonmel 20mg once daily at night adjusting at min. 4-week 2MO intervals according to response; max. 40mg daily Statin. Simvastatin 5mg, 10mg, 20mg, 40mg. as single dose at night. Yellow (5mg) and white oblong biconvex film-ctd. Q Under 18 years, not recommended. tabs. scored on one side and marked SVT5, SVT10, D Active liver disease or unexplained SVT20 and SVT40 resp. 5mg-28, A11.78; 10mg-28, persistent elevation of serum transaminases. A11.87; 20mg-28, A20.15; 40mg-28, A20.15. Pregnancy, lactation. Women of child-bearing S Hypercholesterolaemia: Adjunct to diet potential unless adequate contraception is used. for reduction of elevated total and LDL-cholesterol Porphyria, myopathy. B History of liver disease, alcoholism, renal in patients with hypercholesterolaemia (type IIa) impairment, hypothyroidism, history of hereditary or combined hyperlipidaemia (type IIb) when response to diet and other non-pharmacological muscular disorders or muscular toxicity with a measures is inadequate. CHD: Secondary statin or fibrate. Elderly (q70 years). prevention in patients with elevated plasma Rhabdomyolysis. Perform liver function tests cholesterol (q5.5mmol/L). before and during therapy. Significantly elevated P Hypercholesterolaemia: Initially 10mg CK levels (q5xULN), treatment should not be once daily at night, adjusting at min. 4-week started. intervals according to response. Usual range 10C Digoxin, coumarin anticoagulants, 80mg daily as a single dose at night. CHD: Initially cyclosporin, gemfibrozil and other fibrates, 20mg once daily at night adjusting at min. 4-week nicotinic acid derivatives, azole antifungals, intervals according to response; max. 80mg daily macrolide antibiotics, HIV-protease inhibitors, as single dose at night. delaviridine, amiodarone, verapamil, nefazodone, Q Not recommended. grapefruit juice. D Active liver disease or unexplained A Abdominal pain, constipation, persistent elevation of serum transaminases. flatulence, nausea. Headache, indigestion, Pregnancy or women trying to become pregnant diarrhoea, rash, itch, asthenia. Rarely myopathy. or suspect pregnancy, lactation. Porphyria, myopathy. SIMATOR Pinewood B History of liver disease, alcoholism, renal 2MO impairment, hypothyroidism, history of hereditary muscular disorders or muscular toxicity with a Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. All film-ctd tabs. marked SV 10, SV 20, SV 40 or SV 80 statin or fibrate. Perform liver function tests before and during therapy. resp. on one side and qq on the other. 10mg, C Digoxin, coumarin anticoagulants, 40mg: Shield-shaped, pink tab.; 20mg: Round, cyclosporin, gemfibrozil and other fibrates, orange tab. with a score line. 80mg: Capsule-
LIPIDAEMIC
2.8
nicotinic acid derivatives, azole antifungals, macrolide antibiotics, HIV treatments, amiodarone, verapamil. A Abdominal pain, constipation, flatulence, nausea. Headache, indigestion, diarrhoea, rash, itch, asthenia. Rarely myopathy.
SIMVASTATIN BENTLEY
Bentley
2MO Statin. Simvastatin 10mg, 20mg, 40mg. Oval, biconvex, film-ctd tabs. 10mg: Peach scored marked 0 on each side of scoreline. 20mg and 40mg: Tan-coloured and brick red marked 20 and 40 resp. 10mg-28, A10.20. 20mg-28, A17.35. 40mg-28, A17.35. S Cardiovascular prevention in manifest atherosclerotic CVD or diabetes mellitus with either normal or increased cholesterol levels. As adjunct to diet for treatment of primary hypercholesterolaemia (HC), familial hypercholesterolaemia (FHC) or mixed dyslipidaemia, when no response to diet. P CVD prevention: 20-40mg/day as single dose in the evening. Hyperlipidaemia: Recommended, 10mg once daily in the evening; range 10-80mg. Results within 2 weeks; max. response by 4-6 weeks. Homozygous FHC: 40mg/ day in the evening or 80mg/day in 3 divided doses of 20mg, 20mg and evening dose of 40mg. Max. dose 10mg/day if admin. with ciclosporin, fibrates or niacin. Q Not recommended. D Active liver disease, persistant elevation of serum transaminases, porphyria. Pregnancy, lactation. B Perform liver function tests before and during therapy. Increased risk of myopathy; discontinue if severe symptoms occur, or if CK levels are q 5 x ULN. Check CK levels prior to therapy if: History of muscular disorders, alcoholism, renal impairment, uncontrolled hypothyroidism, elderly (q 70 years). Contains lactose. C Contra: Potent CYP 3A4 inhibitors (see annexe). Avoid grapefruit juice, gemfibrozil, other fibrates, niacin, less potent CYP 3A4 inhibitors, danazol (unless benefit outweighs risk). Caution: Coumarin anticoagulants.
SIMZOR
Gerard
2MO Statin. Simvastatin 10mg, 20mg, 40mg. White to off-white film-ctd oblong scored tabs. 10mg-30, A13.78; 20mg-30, A23.42; 40mg-30, A23.42. S Reduction of elevated plasma and LDLcholesterol in patients with hypercholesterolaemia and combined hyperlipidaemia in combination with dietary measures. For the secondary prevention of CHD in patients with elevated plasma cholesterol levels. P Hyperlipidaemia: Initially 10mg once daily at night, adjusting at min. 4-week intervals according to response. Usual range 10-80mg daily as a single dose at night. CHD: Initially 20mg daily as a single dose in the evening adjusting at min. 4-week intervals according to response; max. 80mg daily as single dose at night. Q Not recommended. D Active liver disease or unexplained persistent elevation of serum transaminases. Women of child-bearing potential, unless adequate contraception is used. Pregnancy, lactation. B Severe renal impairment. History of liver
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
79
2.9 ERYTHROPOIESIS,
CIRCULATORY SYSTEM
GRANULOCYTOPENIA
release nicotinic acid, initiate at starting dose and advance to maintenance dose after 4 weeks. Take whole with food, evening or at bedtime. Avoid alcohol, hot drinks, spicy food at time of ingestion to reduce flushing. Q Not recommended. D Significant or unexplained hepatic dysfunction. Active peptic ulcer disease. Arterial bleeding. Pregnancy (unless clearly necessary), lactation. B Substantial alcohol intake, history of liver disease. Monitor liver function. Combined SIVATIN Rowex therapy, monitor for signs of rhabdomyolysis. Renal dysfunction, diabetes, unstable angina, 2MO acute phase of MI, surgery, predisposition to gout, Statin. Simvastatin 10mg, 20mg, 40mg. Light red, patients at risk of hypophosphataemia, history of orange, red-brown tabs. All film-ctd, oval, scored jaundice, hepato-biliary disorder, peptic ulcer. May and marked SIM 10, SIM 20 or SIM 40. 10mg-30, affect liver function tests, platelets count, uric acid A14.75; 20mg-30, A25.08; 40mg-30, A25.08. and P levels. Contains lactose. S Primary hypercholesterolaemia (HC) or C Nitrates, Ca++ channel blockers, mixed dyslipidaemia as adjunct to diet. Familial adrenergic receptor blockers, bile acid homozygous HC when other treatments not sequestrants, midazolam, zidovudine, clopidogrel, appropriate. Secondary prevention of CHD in cupric sulphate solutions (Benedict’s reagent). patients at high risk with normal or high plasma Simvastatin in Chinese patients. cholesterol levels. A Elevations in ALT and/or AST, fasting P Usual initial dose 10-20mg for high cholesterol and 20-40mg for CHD as single dose in glucose, uric acid. Dizziness, headache, paraesthesia, diarrhoea, dyspepsia, nausea, the evening. Dosage adjustment at min. 4 week intervals. May be increased to 80mg in exceptional vomiting, erythema, pruritus, rash, urticaria, flushing, feeling hot. cases as single dose in the evening. Familial homozygous HC: 40mg in the evening or 80mg in ZOCOR MSD 3 divided doses. Severe renal insufficiency: Caution 2MO with daily doses q10mg. Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. Q Under 18 years, not recommended. Peach oval, tan, red oval and red cap. shaped filmD Active liver disease or unexpected persistent elevation of serum transaminase values, ctd tabs. marked ZOCOR 10, ZOCOR 20, MSD 749, and 543 one side ’80’ on reverse, resp. 10mg-28 porphyria, myopathy. Pregnancy, lactation. B Perform liver functions tests before and (Cal/Pk), A8.27. All 20mg-28, 40mg-28, 80mg-28 (Cal/Pk): A14.06. during therapy. Increased risk of myopathy; S As an adjunct to diet for reduction of discontinue if severe symptoms occur, or if CK elevated total cholesterol, LDL-cholesterol, levels q5xULN. Caution: History of muscular apoloprotein B and triglycerides in patients with disorders or alcoholism, renal insufficiency, uncontrolled hypothyroidism, elderly (q70 years); primary hypercholesterolaemia, heterozygous familial hypercholesterolaemia or combined check CK levels before initiating therapy. Major (mixed) hyperlipidaemia when response to diet surgery (discontinue). Contains lactose. and other non-pharmacological measure is C Potent CYP3A4 inhibitors, i.e. inadequate. To lower LDL/HDL ratio and total itraconazole, ketoconazole, HIV protease cholesterol/HDL ratio by raising HDL.As an adjunct inhibitors, erythromycin, clarithromycin, to diet and other non-dietary measures in telithromycin and nefazodone (all contraindicated), grapefruit juice (avoid). Caution: reducing elevated total cholesterol, LDLcholesterol and apolipoprotein B in patients wihth Gemfibrozil and other fibrates, niacin, other homozygous familial hypercholesterolaemia when CYP3A4 inhibitors, coumarin anticoagulants. response to these measures is inadequate. A GI disturbances. P Hyperlipidaemia: Initially 10mg once TREDAPTIVE MSD daily at night, adjusting at min. 4-week intervals according to response. Usual range 10-80mg daily 2MO as single dose at night. CHD: Initially 20mg daily Nicotinic acid and derivatives. Nicotinic acid, as single evening dose adjusting at min. 4-week 1000mg; laropiprant, 20mg. Cap.-shaped, white to intervals according to response; max. 80mg daily off-white modified-release tabs, with 552 as single dose at night. Homozygous familial debossed on 1 side. 28, A16.79; 56, A33.59. hypercholesterolaemia: 40mg as single dose at S Dyslipidaemia, particularly mixed night or 80mg daily in three divided doses of dyslipidaemia and primary hypercholesterolaemia. 20mg, 20mg and 40mg taken in the evening. In combination with HMG-CoA reductase Q Not recommended. inhibitors (statins), when HMG-CoA reductase D Active liver disease or unexplained inhibitor monotherapy inadequate. As persistent elevation of serum transaminases. monotherapy only if HMG-CoA reductase Pregnancy or women likely to become pregnant, inhibitors inappropriate or not tolerated. lactation. B History of liver disease, alcoholism. P Initially, 1 tab. once a day for 4 weeks. Maintenance: 2 tabs. once daily. If dose missed for Perform liver function tests before and during therapy. Dose related risk of myopathy. Contains q7 consecutive days, resume therapy at 1 tab. daily for 1 week before advancing to maintenance lactose. dose. Switching from r2000mg prolonged-release C Contra: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV nicotinic acid, initiate at maintenance dose. protease inhibitors, or nefazodone. Caution: Other Switching from Q2000mg prolonged-release inhibitors of CYP3A4, some lipid-lowering drugs nicotinic acid and switching from immediatedisease or alcoholism. Perform liver function tests before and during therapy. C Gemfibrozil and other fibrates, nicotinic acid derivatives, ketoconazole, itraconazole, HIVprotease inhibitors, delavirdine, mibefradil, nefazodone, verapamil, erythromycin, clarithromycin, telithromycin, grapefruit juice, digoxin, coumarin anticoagulants. A Hypersensitivity reactions. Rarely, depression, erythema multiforme, Stevens-Johnson syndrome, leucopenia, purpura.
80
(gemfibrozil, other fibrates, niacin (r1 g/day)), cyclosporin, danazol, amiodarone, verapamil, diltiazem, grapefruit juice, oral anticoagulants, fusidic acid. A Abdominal pain, constipation, flatulence.
2.9 ERYTHROPOIESIS, GRANULOCYTOPENIA
ARANESP
Amgen
5NT Human erythropoietin. Darbepoetin alfa 10, 15, 20, 30, 40, 50, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. in pre-filled syringe. 10mcg/0.4ml x 4, A97.06; 15mcg/0.375ml x 4, A145.59; 20mcg/0.5ml x 4, A194.12; 30mcg/0.3ml x 4, A291.18; 40mcg/ 0.4ml x 4, A388.24; 50mcg/0.5ml x 4, A485.30; 60mcg/0.3ml x 4, A582.36; 80mcg/0.5ml x 4, A776.48; 100mcg/0.5ml x 4, A970.60; 150mcg/ 0.3ml x 4, A1455.90; 300mcg/0.6ml x 1, A727.95; 500mcg/1ml x 1, A1091.93.
5NT ALSO ARANESP SURECLICK Darbepoetin alfa 20, 40, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. in pre-filled pen. 20mcg/0.5ml x1, A48.53; 40mcg/ 0.4ml x1, A97.06; 60mcg/0.3ml x1, A145.59; 80mcg/0.4ml x1, A194.12; 100mcg/0.5ml x1, A242.65; 150mcg/0.3ml x1, A363.98; 300mcg/0.6ml x1, A727.95; 500mcg/1ml x1, A1091.93. S Anaemia associated with chronic renal failure in adults and paediatric patients. Anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. V Renal failure patients: See Section 7.3. Cancer patients: See Section 20.1. D Poorly controlled hypertension. Patients suspected or confirmed to have neutralising antibodies to erythropoietin. Lactation. B Evaluate iron status prior and during treatment. Iron suppl. may be required. Monitor BP. Ischaemic heart disease, CHF, sickle cell anaemia, epilepsy. Liver disease (no data). Monitor K+ levels. PCRA (discontinue if occurs). Pregnancy. C Caution: Cyclosporin, tacrolimus. A Headache, hypertension, thrombosis of vascular access, inj. site pain.
EPREX
Janssen-Cilag
5NT Erythropoietin. Epoetin alfa. Range of 1-6 thousand IU, 8000 IU, 10000 IU as well as 40000 IU human recombinant erythropoietin. (r-HuEPO). Soln. in pre-filled syringe. 1000 IU/0.5ml-6x0.5ml, A72.79; 2000 IU/0.5ml-6x0.5ml, A145.59; 3000 IU/ 0.3ml-6x0.3ml, A218.38; 4000 IU/0.4ml-6x0.4ml, A291.18; 5000 IU/0.5ml-6x0.5ml, A363.97; 6000 IU/ 0.6ml-6x0.6ml, A436.76; 8000 IU/0.8ml-6x0.8ml, A582.35; 10,000 IU/1ml-6x1.0ml, A727.94; 40,000 IU/ml-6x1ml, price on request. S Treatment of symptomatic anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, preexisting anaemias at the start of chemotherapy).
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CIRCULATORY SYSTEM To increase yield of autologous blood. To reduce exposure to allogeneic blood transfusions prior to major elective orthopaedic surgery with high risk of transfusion complications. P Haemodialysis: Initially 50 IU/kg three times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg three times per week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance, recommended total weekly dose, 75-300 IU/kg. Peritoneal dialysis: 50 IU/kg twice weekly by IV inj. Increase if necessary by 25 IU/kg twice weekly every 4 weeks to achieve a Hb 1012g/dL. Maintenance, 25-50 IU/kg per week in two equal doses. Non-dialysis: Initially 50 IU/kg 3 times per week by IV inj. Increase if necessary by 25 IU/ kg 3 times/week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance 17-33 IU/kg/week in 3 divided doses; max. 200 IU/kg 3 times/week. May admin. by SC inj. where IV not readily available. Chemotherapy, autologous predonation and major elective orthopaedic surgery: See SPC. Q Haemodialysis: Initially 50 IU/kg 3 times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg 3 times per week every 4 weeks to achieve a Hb 9.5-11g/dL. Maintenance, under 10kg, 75-150 IU/kg; 10-30kg, 60-150 IU/kg; over 30kg, 30-100 IU/kg. All 3 times per week. D Uncontrolled hypertension. Severe coronary, peripheral arterial, carotid or cerebral vascular disease in patients scheduled for major elective orthopaedic surgery and not participating in autologous blood donation. Patients unable to receive antithrombotic prophylaxis. Patients who have developed Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. B Caution: Hypertension, ischaemic vascular disease, thrombocytosis, history of epilepsy, liver failure, increased risk of thrombotic vascular events in cancer patients, porphyria. Correct other causes of anaemia; iron suppl. may be required. Monitor BP, Hb, blood count, serum electrolytes. Limit Hb rise to Q2g/dL per month. Chronic renal failure patients treated by SC route: Monitor regularly for loss of efficacy. Theoretically could stimulate malignant growth. Pregnancy, lactation. C Cyclosporin. A Hypertension, headache, deep vein thrombosis, pulmonary embolism, flu-like symptoms, seizures, rash, palpebral oedema, diarrhoea, vomiting, arthralgia, pyrexia, shunt thromboses. Rarely, PRCA, withdraw and do not transfer to other erythropoietins.
ERYTHROPOIESIS, GRANULOCYTOPENIA 2.9 therapies. Renal impairment (ccQ60ml/min). Pregnancy, lactation. B Monitor serum creatinine, cc, and/or plasma cystatin C levels weekly for the 1st month after initiation or modification of therapy, monthly afterwards. Pre-existing renal conditions, concomitant medicines depressing renal function (increased risk). Maintain adequate hydration in case of diarrhoea or vomiting. Reduce dose if necessary; see SPC. Monitor weight, height and sexual development in children every 12 months. Monitor cardiac function in patients with severe iron overload during long-term treatment. Contains lactose. C Not recommended: Aluminiumcontaining preparations. Rifampicin, phenobarbital, phenytoin, CYP2C8 substrates (e.g. paclitaxel, repaglinide). A Headache, GI disorders, increased blood creatinine, proteinuria, increased transaminases, rash, pruritus.
5NT
Recombinant human erythropoietin. Epoetin beta 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10000 IU, 20000 IU, 30000 IU. Pre-filled syringes: 500 IU-6, A36.40; 2000 IU-6, A145.59; 3000 IU-6, A218.38; 4000 IU-6, A291.18; 5000 IU-6, A363.97; 6000 IU-6, A436.76; 10000 IU-6, A727.94; 20000 IU-6, A1455.80; 30000 IU-4, A1237.48. S Anaemia associated with chronic renal failure in dialysis or pre-dialysis patients. Prevention and treatment of anaemia in adult patients undergoing platinum-based chemotherapy, patients with multiple myeloma, non-Hodgkin’s lymphoma or chronic lymphocytic leukaemia with low serum erythropoietin. Prevention of anaemias of prematurity in infants of gestational age less than 34 weeks. To increase yield of autologous blood. V Chronic renal failure, SC initially 3 x 20 IU/kg body weight per week. Increasing every 4 weeks by 3 x 20 IU/kg per week if the increase in PCV is Q0.5% per week. Weekly dose can be GRANOCYTE Chugai given as one inj. or in divided doses. IV admin. initially 3 x 40 IU/kg per week. Increasing after 4 5NT weeks to 3 x 80 IU/kg per week and if further Recombinant human granulocyte-colony increments are required by 3 x 20 IU/kg per week stimulating factor, rHu G-CSF. Lenograstim. at monthly intervals. Max. 720 IU/kg per week. Powder in vial plus prefilled syringe with WFI. Maintenance, initially reduce to half previous Granocyte-34: 33.6 MIU/vial. 5 x 1ml vial plus 5 x dose, then adjust to individual requirements at 1 1ml pre-filled syringe WFI or inf. Granocyte-13: or 2 week intervals. Children, follow 13.4 MIU/vial. 5 x 1ml vial plus 5 x 1ml pre-filled recommended dosing schedule. Solid tumours, by syringe WFI or inf. Price available on request. SC inj. initially 450 IU/kg per week, this dose may S Non-myeloid malignancy: reduction in be doubled if patient does not show a satisfactory duration of neutropenia and associated response in terms of haemoglobin values. complications following bone-marrow Continue therapy for up to 3 weeks after end of transplantation or following treatment with chemotherapy. Haematological tumours, see SPC. cytotoxic chemotherapy associated with significant Autologous blood pre-donation, by IV or SC incidence of febrile neutropenia. Granocyte may be admin. to patients with de novo acute myeloid admin. over approx. 2 mins. twice weekly over 4 weeks, see SPC. leukaemia aged above 55 years. Mobilisation of D Uncontrolled hypertension. For peripheral blood progenitor cells (PBPCs). P Cytotoxic-induced neutropenia: 150mcg/ increasing yield of autologous blood if the month preceding treatment the patients have suffered m2/day (equiv. 5mcg/kg/day) by SC inj. started on MI, stroke, have unstable angina, are at risk of day after completion of chemotherapy, continue DVT. until neutrophil count stable in acceptable range B Hypertension, thrombocytosis. History of (max. 28 days). Bone marrow transplantation: epilepsy. Chronic hepatic failure. Correct other 150mcg/m2/day (equiv. 5mcg/kg/day) by IV inf. started on day after completion of chemotherapy; causes of anaemia; iron suppl. may be necessary. continue until stable in acceptable range (max. 28 Monitor Hb, BP, platelet count, serum electrolytes. days). Mobilisation of PBPCs used alone: 10mcg/kg/ Limit Hb rise to Q2g/dL per month. Theoretically could stimulate malignant growth. Neonates day daily for 4-6 days by SC inj. following adjunctive myelosuppressive chemotherapy 5mcg/ (except NeoRecormon 500). Pregnancy, lactation. A Hypertension, shunt thrombosis, kg/day by SC inj. started on day after completion anaphylactoid reaction, increased platelets. of chemotherapy until neutrophil count in acceptable range. For timing of leukapheresis EXJADE Novartis consult lit. NEULASTA Amgen 2NT Q Over 2 years, cytotoxic-induced 5NT neutropenia 150mcg/m2/day (equiv. 5mcg/kg/day Iron chelating agent. Deferasirox 125mg, 250mg, Recombinant human granulocyte colony 500mg. Off-white, round, flat dispersible tab. with by SC inj. started on day after completion of stimulating factor (G-CSF). Pegfilgrastim 6mg/ NVR on one face and J125, J250, J500 resp. on the chemotherapy, continue until neutrophil count 0.6ml. Pre-filled syringe. 1, A1212.00. stable in acceptable range (max. 28 days). Bone other. 125mg-28, A207.90; 250mg-28, A415.80; S Reduction in the duration of marrow transplantation 150mcg/m2/day (equiv. 500mg-28, A831.60. neutropenia and incidence of febrile neutropenia S Treatment of chronic iron overload due 5mcg/kg/day) by IV inf. started on day after in patients treated with cytotoxic chemotherapy to frequent blood transfusions (r7ml/kg/month of completion of chemotherapy continue until stable for malignancy with the exception of chronic in acceptable range (max. 28 days). packed red blood cells) in patients with beta myeloid leukaemia, myelodysplastic syndrome and D Myeloid malignancy. De novo acute thalassaemia major aged 6 years and older. secondary acute myeloid leukemia (AML). myeloid malignancy aged below 55 years and/or Treatment of chronic iron overload due to blood P 6mg SC inj. for each chemotherapy cycle with good cytogenics. transfusions when deferoxamine therapy is 24 hours after cytotoxic chemotherapy. B Myelodysplasia, severe hepatic or renal contraindicated or inadequate in patients with Q Under 18 years, not recommended. impairment. Monitor for leucocytosis, pulmonary other anaemias; in patients aged 2 to 5 years; in D Pregnancy, lactation. adverse effects graft vs host disease in BMT. patients with beta thalassaemia major with iron B Caution: Patients with AML, sickle cell Pregnancy, lactation. overload due to infrequent blood transfusions disease. If preliminary signs of ARDS appear, C Cytotoxic drugs. (Q7 ml/kg/month of packed red blood cells). discontinue. Splenic rupture. Monitor platelet A Bone pain, headache. P See SPC. count and haematocrit. Needle cover contains dry Q See SPC. natural rubber (may cause allergic reactions). NEORECORMON Roche Interpreting bone-imaging results: Consider D Combination with other iron chelator AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
81
2.9 ERYTHROPOIESIS,
increased haematopoietic activity of bone marrow in response to growth factor therapy. Contains sorbitol, Na+ acetate. C Admin. 24 hours after cytotoxic chemotherapy. A Skeletal pain, inj. site pain, chest pain (non-cardiac), pain, headache, arthralgia, myalgia.
NEUPOGEN
Amgen
5NT Recombinant human granulocyte colony stimulating factor (G-CSF). Filgrastim 30 MU/ml. Liquid in single dose vial. 30 MU-5 x 1ml, A521.75.
5NT ALSO NEUPOGEN SINGLEJECT Filgrastim 30 MU, 48 MU per 0.5ml. Pre-filled syringes. 30 MU-5 x 0.5ml, A597.73. 48 MU-5 x 0.5ml. A953.13. S Reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy; reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. Long term treatment to increase neutrophil counts (NC) and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic or idiopathic neutropenia and history of severe or recurrent infections. Mobilisation of peripheral blood progenitor cells (PBPCs). HIV associated neutropenia . V Established cytotoxic chemotherapy: 0.5MU daily IV or SC 24 hrs after therapy. Bone marrow transplantation: Initially 1MU daily, as 30 mins. or 24 hr IV inf. or 24 hr SC inf. within 24 hrs. Both uses: Titrate against neutrophil response once nadir passed. Mobilisation of PBPCs: Alone, 1MU daily SC as 24 hr inf. or single inj. for 5-7 days. Leukapheresis: 1 or 2 on days 5 and 6. Following myelosuppressive chemotherapy: 0.5MU SC daily from day 1 post therapy until neutrophil nadir passed and NC at normal range. Leukapheresis: When the ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single apheresis often sufficient. Other circumstances, additional leukaphereses recommended. HIV Infections: See SPC. Severe chronic neutropenia: Congenital neutropenia, 1.2MU daily; Idiopathic or cyclic neutropenia, 0.5 MU SC; as single inj. or in divided doses. Continue until NC at q1.5 x109/L, ascertain min. required to maintain. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average NC between 1.5 x 109/L and 10 x 109/L. Severe infections, consider faster dose escalation; long-term safety of q 2.4MU daily not established. B Myelodysplastic syndrome, chronic myelogenous leukaemia. Sickle cell disease; caution. Monitor for leukocytosis, osteoporosis, pulmonary symptoms, splenomegaly. Contains sorbitol. Pregnancy (only if benefit outweighs risk), lactation. Needle cover of pre-filled syringe contains dry natural rubber. Increased haematopoietic activity of the bone marrow has been associated with transient positive boneimaging findings. A Musculo-skeletal pain, reversible increase in liver enzymes and serum uric acid, transient hypotension, rarely allergic-type reactions, cutaneous vasculitis, proteinuria, haematuria.
RATIOGRASTIM
ratiopharm
5NT Recombinant human granulocyte colony
82
CIRCULATORY SYSTEM
GRANULOCYTOPENIA stimulating factor (G-CSF) Filgrastim 60MIU/ml. Clear, colourless sln for inj. or inf. in pre-filled syringes. 30 MIU/0.5ml-5, A448.37; 48MIU/0.8 ml-5, A 714.96. S Reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy; reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. Long term treatment to increase neutrophil counts (NC) and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic or idiopathic neutropenia and history of severe or recurrent infections. Mobilisation of peripheral blood progenitor cells (PBPC). HIV associated neutropenia. V Established cytotoxic chemotherapy: 0.5MIU/kg/day as a daily SC injection or IV infusion less than 24 hours following therapy. Bone marrow transplantation: Initially 1MIU/kg/day as 30 min or 24 hr IV inf. or by continuous SC inf. within 24 hrs. Titrate against neutrophil response (see SPC). Mobilisation of PBPCs: Alone, 1MIU/kg/ day as 24 hour SC continuous inf. or a single daily SC inj. for 5-7 consecutive days. Leukapheresis: 1 or 2 on days 5 and 6. PBC mobilisation after myelosuppressive chemotherapy: 0.5MIU/kg/day by SC inj. from 1st day after chemotherapy completion until neutrophil nadir passed and ANC in normal range; leukapheresis: When ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single leukapheresis often sufficient. Severe chronic neutropenia: Congenital neutropenia, 1.2MIU/kg/ day SC as single dose or in divided doses. Idiopathic or cyclic neutropenia, 0.5MIU/kg/day SC; as single dose or in divided doses. Continue until ANC at q1.5 x109/L, establish minimum required to maintain this level. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average ANC between 1.5 x 109/L - 10 x 109/L. Severe infections, consider faster dose escalation; long-term safety of doses q 2.4MIU/kg/day not established. HIV Infections: Reversal of neutropenia, initially 0.1MIU/kg/day by SC inj. with titration up to max 0.4MIU/kg/day until a normal ANC reached and maintained (ANC q 2.0 x 109/L). Doses up to 1MIU/kg/day may be needed in some patients. Maintaining normal ANC: Establish minimal effective dose; initial dose adjustment to alternate day dosing with 30MIU/day by SC injection. Further dose adjustment may be necessary depending on patientâ&#x20AC;&#x2122;s ANC. Long term admin. may be required. B Myelodysplastic syndrome, chronic myelogenous leukaemia: Safety not established. Caution: Secondary AML, underlying osteoporotic bone diseases (treatment q 6 months, monitor bone density), recent history of pulmonary infiltrates or pneumonia, high dose chemotherapy. Perform white blood cell count regularly. Regular monitoring of platelet count and haematocrit recommended. Increased haematopoietic activity of the bone marrow has been associated with transient positive bone-imaging findings. Pregnancy (only if benefit outweighs risk), lactation. Contains sorbitol. See SPC. C Not recommended within 24 hours of chemotherapy. A Musculoskeletal pain. Cancer patients: Elevated alkaline phosphatase/LDH/uric acid, headache, cough, sore throat, GI disorders, elevated GGT, alopecia, skin rash, chest pain, fatigue, generalised weakness. Mobilisation of
PBPCs: Leukocytosis, thrombocytopenia, elevated alkaline phosphatise/LDH, headache. SCN patients: Anaemia, splenomegaly, thrombocytopenia, decreased glucose, elevated alkaline phosphatase/ LDH, hyperuricaemia, headache, epistaxis, diarrhoea, hepatomegaly, alopecia, cutaneous vasculitis, injection site pain, rash, osteoporosis. HIV patients: Spleen disorder.
RETACRIT
Hospira
5NT Erythropoietin. Epoetin zeta. Clear, colourless sln for inj. in pre-filled syringe. 1000 IU/0.3ml-6, A54.59; 2000 IU/0.6ml-6, A104.82; 3000 IU/0.9ml-6, A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5ml6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ 0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, A273.01; 40000 IU/1ml-1, A363.97. S Anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis. Severe anaemia of renal origin with clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by patientâ&#x20AC;&#x2122;s general status. To increase yield of autologous blood from adult surgery patients in a predonation programme (see SPC). P Chronic renal failure (haemodialysis): Correction phase, 50 IU/kg IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance total weekly dose 75-300 IU/kg. Chronic renal failure (peritoneal dialysis): Correction phase, 50 IU/kg (IV) twice weekly; maintenance, 25-50 IU/Kg (IV) twice weekly. Renal insufficiency without dialysis: Correction phase, 50 IU/kg (IV) thrice weekly; adjust dose if necessary by 25 IU/kg thrice weekly in steps of at least 4 weeks. Maintenance, 17-33 IU/kg thrice weekly. Cancer patients receiving chemotherapy: Initially 150 IU/kg subcutaneously thrice weekly, alternatively 450 IU/kg once weekly. Continue until 1 month after the end of chemotherapy (see SPC for dose adjustment). Autologous predonation programme: Mildly anaemic patients (Hct 33-39%) requiring predeposit of q4 blood units, 600 IU/kg (IV) twice weekly after blood donation procedure for 3 weeks prior to surgery, with adequate iron supplement. Q Chronic renal failure (haemodialysis): Correction phase as per adults. Maintenance, see SPC. D Patients with Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. Uncontrolled hypertension. Patients unable to receive adequate antithrombotic prophylaxis. Autologous predonation programme: MI or stroke in month preceding treatment, unstable angina pectoris, increased DVT risk . B Correct other causes of anaemia; ensure adequate iron stores. Monitor BP, platelet count, reticulocyte count, Hb. Chronic renal failure: Monitor serum electrolytes; hyperkalaemia may occur (discontinue until corrected). Caution: Epilepsy, chronic liver failure. PRCA may occur (discontinue immediately, see SPC). Increased risk of thrombotic vascular events in cancer patients. Tumour growth potential cannot be excluded. Pregnancy, lactation (only if benefit outweighs risk). Contains phenylalanine.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS weeks, max. 4 weeks including tapering off process. R Reduced dose. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. Pregnancy, lactation (unless essential). 3.1 INSOMNIA B Great caution: Renal/hepatic impairment, elderly, debilitated, chronic CIRCADIN Lundbeck pulmonary insufficiency, history of alcohol or drug 2N abuse. Anterograde amnesia, psychiatric and paradoxical reactions, dependence; may occur. Melatonin 2mg. White to off white round, Withdraw gradually (warn patient about possible biconvex prolonged-release tabs. 21, A14.51. rebound phenomena). Driving/using machines. S Short-term treatment of primary insomnia characterised by poor quality of sleep in Contains lactose. C Avoid alcohol. Caution: Antipsychotics, patients aged 55 or over. hypnotics, anxiolytics/ sedatives, antidepressants, P 2mg once daily swallowed whole, 1-2 narcotic analgesics, AEDs, anaesthetics and hours before bedtime and after food. Continue sedative antihistamines, P450 inhibitors. for three weeks. A Start: Drowsiness, numbed emotions, Q Under 18 years, not recommended. B Not recommended: Hepatic impairment, dizziness, confusion, fatigue, headache, muscle weakness, ataxia, double vision. autoimmune diseases, pregnancy, lactation, lactose/sugar intolerance. Caution: Renal HALCION Pharmacia insufficiency, driving/using machines. C Avoid alcohol, fluvoxamine. Caution: 2NO Hypnotics, 5 and 8-MOP, cimetidine, smoking, Short-acting benzodiazepine. Triazolam 0.125mg, oestrogens, CYP1A2 inhibitors (eg. quinolones), 0.25mg. Lavender ellipitical tab. marked UPJOHN CYP1A2 inducers (e.g. carbamazepine, rifampicin). 10 and blue elliptical flat bevelled edge, single Potential interaction with adrenergic agonists/ score tab. marked UPJOHN 17 resp. 0.125mg-30, antagonists and certain CNS drugs. A1.96; 0.25mg-30, A1.73; 250, A14.41. A Headache, pharyngitis, back pain, S Short-term management of insomnia asthenia. which is severe, disabling or causing extreme distress. DALMANE Meda P 0.125-0.25mg at bedtime. Max. 2NO treatment duration, 4 weeks. Long-acting benzodiazepine. Flurazepam (HCl) R 0.125mg. At bedtime. Max. treatment 15mg, 30mg. 15mg Grey/yellow cap. marked duration, 4 weeks. ICN15. 30mg black/grey cap. marked ICN30. 15mg- Q Not recommended. 30, A3.49; 30mg-30, A4.62. D Myaesthenia gravis, severe respiratory S Insomnia, when severe and disabling. or hepatic insufficiency, sleep apnoea syndrome. P 5-30mg at bedtime. Duration: A few B Tolerance, dependence & associated days to 2 weeks, max. 4 weeks. Hospitalised withdrawal symptoms. Discontinue if psychiatric patients, single dose of 20mg may be given. and paradoxical reactions occur. Anterograde R Max. 15mg amnesia may occur. History of alcohol or drug Q Not recommended. abuse. Should not be used alone to treat D Myasthenia gravis, severe respiratory depression or anxiety associated with depression. insufficiency, sleep apnoea, severe hepatic Elderly, children. Pregnancy, lactation (only if insufficiency, phobic or obsessional states, chronic considered essential). Driving or using machinery. psychosis. Pregnancy, lactation. C Alcohol, CNS depressants. B Chronic respiratory insufficiency. Driving A Drowsiness, numbed emotions, reduced or operating machinery, history of alcohol or drug alertness, confusion, fatigue, headache, dizziness, abuse. Anterograde amnesia, psychiatric and muscle weakness, ataxia, double vision. paradoxical reactions, dependence; may occur. INSOMNIGER Gerard Reevaluate when extension beyond max. is necessary. Discontinue gradually. Elderly. 2NO C Not recommended: Alcohol. Caution: Benzodiazepine. Temazepam 10mg, 20mg. WhiteAntipsychotics, hypnotics, anxiolytics/sedatives, pale yellow, round, flat beveled-edge scored tabs. antidepressants, narcotic analgesics, antiepileptic marked T/10 and T/20 resp. on the scored side, drugs, anaesthetics, sedative antihistamines, and G on the other. 10mg-100, A3.73; 20mg-100, CYP450 inhibitors. A5.74. A Drowsiness, numbed emotions, fatigue, S Short-term management of insomnia reduced alertness, confusion, headache, dizziness, only when severe, disabling or subjecting the muscle weakness, ataxia, double vision. individual to extreme distress. Premedication prior to minor surgery or other related procedures. DALMAPAM Pinewood P Insomnia: 10-20mg on retiring or up to 2NO 30 mins before bedtime. Exceptionally may be Long-acting benzodiazepine. Flurazepam (HCl) increased to 30-40mg. Duration, a few days to 2 15mg, 30mg. Ivory/light grey and grey/black hard weeks. Max., incl. tapering-off, 4 weeks. gelatin caps. marked FLU 15 and FLU 30, resp. Premedication: 20-40mg, 30-60 mins before 15mg-30, A3.45; 30mg-30, A4.60. procedure. R Insomnia: 10mg. Exceptionally, may be S Insomnia, when severe and disabling. increased to 20mg. Premedication: Possibly half P 15-30mg before retiring. Duration as the normal adult dose or less. short as possible, generally from few days to 2 C Ciclosporin. A Headache, dose-dependent increase in BP, hypertensive crisis with encephalopathy-like symptoms, skin rashes, flu-like symptoms, PRCA, antibodies to erythropoietins, hypersensitivity reactions, thrombotic/vascular events, shunt thromboses.
INSOMNIA 3.1 Q Under 18 years, not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency. Pregnancy, lactation. B Anterograde amnesia may occur. Caution: Chronic respiratory insufficiency, impaired renal or liver function, history of alcohol or drug abuse. Driving/operating machines. Reevaluate when extension beyond max. is necessary. Discontinue gradually. C Alcohol (not recommended). Caution: CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines, disulfiram, inhibitors of cyt. P450. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, or double vision. Usually transient.
MOGADON
Meda
2NO Long-acting benzodiazepine. Nitrazepam 5mg. White scored tab. marked ICN. 30, A1.11. S Short-term treatment of insomnia when severe, disabling or subjecting the individual to extreme distress. P Elderly, 2.5mg; others, 5-10mg. Both at bedtime. Hospitalised patients; single dose of 20mg may be given. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, phobic or obsessional states, chronic psychosis. Pregnancy, lactation. B Tolerance, physical dependence; withdraw gradually. Do not exceed 4 weeks without re-evaluation. Anterograde amnesia, psychiatric reactions may occur. Caution: Children (duration kept to min.), elderly, history of alcohol/ drug abuse. Not for treatment of psychotic illness. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants, CYP450 inhibitors. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision.
NOCTAMID
Bayer Schering
2NO Int.-acting benzodiazepine. Lormetazepam 1mg. White round scored tab. marked in a hexagon with CF. Can be divided into equal halves. 30, A3.52 S Short-term treatment of insomnia. P 1mg at bedtime. R 0.5mg at bedtime. Q Depends on patient’s age, weight and general condition. Keep duration to a minimum D Myasthenia gravis. Severe respiratory insufficiency (e.g. severe COPD), sleep apnoea syndrome. Acute intoxication with alcohol, hypnotics, analgesics or psychotropic drugs (neuroleptics, antidepressants, lithium). B Not recommended for the primary treatment of psychotic illness. Not to be used alone for the treatment of sleep disorders associated with depression. Keep treatment duration as short as possible (usually few days to 2 weeks; 4 weeks max. incl. gradual dose reduction). May lead to the development of physical and psychic dependence; withdraw gradually. May induce anterograde amnesia. Caution: Severe
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
83
3.1 INSOMNIA
CNS
hepatic / renal insufficiency, chronic respiratory insufficiency, elderly. Increased risk of falling due to adverse effects incl. ataxia, muscle weakness, dizziness, somnolence/sleepiness, fatigue. Discontinue if psychiatric and paradoxical reactions occur. Contains lactose. C Not recommended: Alcohol. Caution: CNS depressants, narcotic analgesics. A Headache. Quinckeâ&#x20AC;&#x2122;s oedema, anxiety, decreased libido, dizziness, sedation, somnolence, disturbance in attention, amnesia, visual impairment, speech disorder, dysgeusia, slowed thinking, tachycardia, GI disorders, pruritus, micturition disorder, asthenia, sweating.
ROHYPNOL
Roche
2LO
Orion
2LO
Int.-acting benzodiazepine. Flunitrazepam 1mg. Greyish-green oval scored tab. marked 542. 30, A4.03. S Short-term treatment of disabling or severely distressful insomnia. P Elderly, v at bedtime; others, v-1 at bedtime. Duration: Usual, a few days - 2 weeks; max. 4 weeks. Q Contraindicated. D Respiratory depression, phobic or obsessional states, myasthenia gravis, sleep apnoea, severe hepatic insufficiency, acute pulmonary insufficiency. Pregnancy, lactation. NORTEM Teva B Tolerance, physical and psychological dependence; withdraw gradually. Anterograde 2LO amnesia may occur. Psychiatric reactions. Caution: Int.-acting benzodiazepine. Temazepam 10mg, Elderly, history of alcohol/drug abuse. Contains 20mg. White scored tabs. marked with twin lactose. Driving/operating machinery. triangle logo one side and coded TMZ 10 or TMZ 20 on reverse. 10mg-100, A4.39; 20mg-100, A6.75. C Neuroleptics, tranquillisers, S Short term treatment of insomnia when antidepressants, hypnotics, analgesics, anaesthetics, anti-epileptics, sedative anti-histamines. CYP450 severe, disabling or subjecting the individual to inhibitors/inducers. extreme distress. Premedication prior to minor A Drowsiness, numbed emotions, reduced surgery or other related procedures. alertness, confusion, fatigue, headache, dizziness, P Insomnia: Elderly, 10mg; max. 20mg. muscle weakness, ataxia, double vision. Others, 10-30mg; max. 40mg. Both at bedtime. Max. duration: 4 weeks. Pre-medication: 20-40mg SONATA Meda 30-60 min before procedure. 2NO Q Not recommended. Pyrazolopyrimidine hypnotic. Zaleplon 5mg. Both D Myasthenia gravis, severe respiratory hard caps. White/light brown with gold band and insufficiency, sleep apnoea, severe hepatic white with pink band resp. Both marked W and insufficiency. Pregnancy, lactation. strength. 5mg-14, A3.28; 10mg-14, A4.71. B Tolerance, dependence, rebound S Short-term treatment of insomnia in insomnia and anxiety: Withdraw gradually. Anterograde amnesia, psychiatric and paradoxical patients who have difficulty falling asleep. reactionss may occur. Elderly. History of alcohol or P 10mg immediately before or after going to bed. drug abuse. Narrow angle glaucoma. Periodic R 5mg. blood and liver function tests for repeated Q Under 18 years, not recommended. therapy. Driving/using machines. D Severe hepatic insufficiency, myasthenia C Avoid alcohol. Caution: CNS gravis, severe respiratory insufficiency. depressants, CYP450 inhibitors. A Drowsiness, numbed emotions, reduced B Chronic renal or hepatic disease. Physical and psychic dependence. Pregnancy, alertness, confusion, fatigue, headache, dizziness, lactation. muscle weakness, ataxia, double vision. C Alcohol and other CNS depressants, NYTAMEL Clonmel cimetidine, rifampicin, carbamazepine, phenobarbitone. 2NO A Amnesia, depression, restlessness, Imidazopyridine hypnotic. Zolpidem tartrate 5mg irritation, aggression, delusions, rages, nightmares, white oval film-ctd tab. marked ZIM and 5; 10mg hallucinations, dependence. white oval film-ctd tab. scored both sides and marked ZIM and 10. 5mg-28, A2.25; 10mg-28, STILNOCT Sanofi A4.51. 2NO S Short term management of insomnia. Imidazopyridine hypnotic. Zolpidem hemitartrate P 10mg before retiring. 5mg white film-ctd tab. 10mg white scored R 5mg before retiring. oblong film-ctd tab. marked SN 10. 5mg-28, Q Not recommended. A1.41; 10mg-28, A2.82. D Severe hepatic insufficiency, sleep S Short term treatment of insomnia. apnoea syndrome, myasthenia gravis, severe P 10mg before retiring. respiratory insufficiency, psychotic illness. R 5mg before retiring. B Renal hepatic or respiratory Q Not recommended. insufficiency. Depression, history of alcohol or drug abuse. Pregnancy, lactation. Warn of possible D Obstructive sleep apnoea, myasthenia gravis, severe hepatic or acute pulmonary drowsiness. insufficiency, respiratory depression, psychotic C Alcohol, CNS depressants, drugs that illness. inhibit certain hepatic enzymes (particularly B Hepatic or renal impairment. cytochrome P450). Depression. History of drug or alcohol abuse. A Drowsiness, headache, dizziness, Pregnancy, lactation. Warn of possible drowsiness. numbed emotions, reduced alertness, confusion, C Alcohol, other CNS depressants. vertigo, fatigue, muscle weakness, ataxia or A GI upset, dizziness, headache, double vision, GI disturbances, changes in libido, skin reactions, amnesia, depression, psychiatric and drowsiness. Very rarely, memory loss, tremor, depression, confusion, perceptual disturbances. paradoxical reactions, dependence.
84
TENOX
Int.-acting benzodiazepine. Temazepam 10mg, 20mg. Off-white scored tab. A10mg-100, A5.13; 20mg-100, A11.46. S Short term management of insomnia. P 10-30mg before retiring, increasing to max. 60mg. R Usually 10mg. Q Not recommended. D See SPC.
ZILEZE
Pinewood
2NO Cyclopyrrolone. Zopiclone 3.75mg, 7.5mg. Orange and white film-ctd tabs. marked ZOC 3.75 and ZOC 7.5, resp. 3.75mg-28, A5.23; 7.5mg-28, A6.11. S Short-term management of insomnia. P Start with lowest recommended dose. 7.5mg 30-60 minutes before retiring for max. 4 weeks including tapering off process. Diminished hepatic/renal function: Minimum dose recommended. Moderate hepatic/renal insufficiency: 3.75mg/day (caution). Severe hepatic/ renal insufficiency: Max 3.75mg/day . R Initially 3.75mg. Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency. Pregnancy, lactation. B Renal, hepatic or respiratory insufficiency; half dose. Driving/using machines. History of alcohol or drug abuse. Withdraw gradually to avoid rebound insomnia. May lead to physical and psychic dependence and result in withdrawal phenomena (high dosage). Amnesia, Psychiatric and paradoxical reactions may occur. C Avoid alcohol. Caution: Antipsychotics, hypnotics, anxiolytics/ sedatives, antidepressants, narcotic analgesics, AEDs, anaesthetics, sedative antihistamines, P450 inhibitors, erythromycin, quinupristin/dalfopristin. A Headache, dizziness, bitter taste, dry mouth, blurred vision, depression, GI disturbances. Psychiatric and paradoxical reactions eg. restlessness, aggressiveness, psychoses. Anterograde amnesia, dependence, morning drowsiness/incoordination, lightheadedness, occasional irritability.
ZIMOCLONE
Gerard
2NO Cyclopyrrolone. Zopiclone 7.5mg. White oval filmctd scored tab. marked zz one side and 7.5 on reverse. 28, A6.13. S Short-term management of insomnia. P 7.5mg at night. R Initially 3.75mg at night. (Dose also applies to patients with hepatic, renal impairment and chronic respiratory insufficiency). Q Not recommended. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency. Pregnancy, lactation. B Renal, hepatic or respiratory insufficiency. Patients should not drive or operate machinery until it is established that mental and physical ability has not been impaired. History of alcohol or drug abuse. C Alcohol, CNS depressants, drugs that inhibit certain hepatic enzymes (particularly cytochrome P450). A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness,
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS slowly. C Alcohol, other CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, anti-epileptics, sedative antihistamines. ZIMOVANE Meda A Drowsiness, headach, dizziness, numbed emotions, reduced alertness, confusion, vertigo, GI 2NO disturbances (diarrhoea, nausea, vomiting), double Cyclopyrrolone. Zopiclone 7.5mg. White scored vision, skin reactions, amnesia. A film-ctd tab. 28, 3.68. S Short term management of insomnia. ZOPITAN Clonmel P 1 at night. R Initially 3.75mg. Dosage should be kept 2 N O to a minimum. Hepatic insufficiency: Max. 3.75mg Cyclopyrrolone. Zopiclone 3.75mg orange film-ctd daily. Renal insufficiency: Max. 7.5mg daily. tab. marked ZOC 3.75; 7.5mg white film-ctd tab. Q Not recommended. marked ZOC 7.5 and scored both sides. 3.75mg-28, A5.15; 7.5mg-28, A5.99 D Myasthenia gravis, respiratory failure, sleep apnoea, severe hepatic insufficiency. S Short-term management of insomnia. Pregnancy, lactation. P 7.5mg at night. B Epilepsy, renal, hepatic or respiratory R Initially 3.75mg at night. (Dose also insufficiency. Patients should not drive or operate applies to patients with hepatic, renal impairment machinery until it has been established that and chronic respiratory insufficiency). mental and physical ability has not been impaired. Q Not recommended. History of alcohol abuse. D Myasthenia gravis, severe respiratory C Alcohol, CNS depressants, trimipramine, insufficiency, sleep apnoea, severe hepatic drugs dependent on hepatic oxidative pathways insufficiency. Pregnancy, lactation. for metabolism (e.g. cimetidine). B Renal, hepatic or respiratory A Morning drowsiness, inco-ordination, insufficiency. Patients should not drive or operate headache, dizziness, bitter taste and dry mouth. machinery until it is established that mental and Irritability, depression or nervousness. Amnesia, physical ability has not been impaired. History of automatism, confusion, nightmare, hangover. alcohol or drug abuse. C Alcohol, CNS depressants, drugs that ZOLDEM Gerard inhibit certain hepatic enzymes (particularly cytochrome P450). 2NO A Drowsiness, numbed emotions, reduced Imidazopyridine hypnotic. Zolpidem (tartrate) 10mg. White to off-white cap. shaped tab. marked alertness, confusion, fatigue, headache, dizziness, ZM breakline 10 on one side and G on reverse. 28, muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, A4.69. bitter taste, amnesia, depression, psychiatric and S Short term treatment of severe, paradoxical reactions, dependence. disabling insomnia. P 10mg immediately before going to bed. ZORCLONE Teva Debilitated patients, hepatic insufficiency: 5mg. 2NO R 5mg. Q Under 18 years, not recommended. Cyclopyrrolone. Zopiclone 7.5mg. White film-ctd D Severe hepatic insufficiency, sleep tab. marked Zoc 7.5 and scored both sides. 28, A5.52. apnoea syndrome, myasthenia gravis, severe respiratory insufficiency. Pregnancy, lactation (no S Short-term treatment of insomnia. data). P 7.5mg at night. B Treat cause of insomnia first. Evaluate R Initially 3.75mg at night. (Dose also psychiatric or physical disorder (if no remission applies to patients with hepatic, renal impairment after 7-14 days treatment). and chronic respiratory insufficiency). C Alcohol. Caution: Antipsychotics Q Not recommended. (neuroleptics), hypnotics, anxiolytics/sedatives/ D Myasthenia gravis, severe respiratory muscle relaxants, antidepressant agents, narcotic insufficiency, sleep apnoea, severe hepatic analgesics, antiepileptic drugs, anaesthetics and insufficiency. Pregnancy, lactation. sedative antihistamines. B Renal, hepatic or respiratory A Drowsiness, headache, dizziness, insufficiency. Patients should not drive or operate numbed emotions, reduced alertness, confusion, machinery until it is established that mental and vertigo, GI disturbances, double vision, skin physical ability has not been impaired. History of reactions, amnesia. alcohol or drug abuse. C Alcohol, CNS depressants, drugs that ZOLNOD Rowex inhibit certain hepatic enzymes (particularly cytochrome P450). 2NO Imidazopyridine hypnotic. Zolpidem tartrate 10mg. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, White scored oblong film-ctd tab. 30, A5.03. muscle weakness, ataxia or double vision, GI S Short term treatment of insomnia. P 10mg daily before retiring. Elderly, 5mg disturbances, changes in libido, skin reactions, daily. Duration of treatment should be as short as bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence. possible, max. 4 weeks. Q Under 18 years, not recommended. 3.2 ANXIETY DISORDERS D Severe hepatic insufficiency, sleep apnoea syndrome, myasthenia gravis, severe ANXICALM Clonmel respiratory insufficiency. B Some loss of efficacy may develop after 2 N O Long-acting benzodiazepine. Diazepam 2mg, 5mg, repeated use. Pregnancy, lactation. Reduce dose muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence.
ANXIETY
DISORDERS
3.2
10mg. White scored tab. marked D2, yellow scored tab. marked D5, blue scored tab. marked D10. 2mg-90, A1.01; 5mg-90, A1.54; 10mg-90, A3.81. S Anxiety, tension, psychosomatic disorders. P 2-10mg three times daily. D See SPC. C Compounds which can inhibit certain hepatic enzymes.
ATIVAN
Wyeth
2NO Int.-acting benzodiazepine. Lorazepam 1mg. White, round, flat bevelled-edged scored tab. impressed with 1.0 on one side. 1mg-100, A3.03. S Short term treatment of moderate to severe anxiety. P Elderly, 0.5-2mg daily; others, 1-4mg daily in divided doses. Q Not recommended. D See SPC.
BETA-PROGRANE
Tillomed
3MO Non-cardioselective b-blocker. Propranolol (HCl) 80mg, 160mg. White hard prolonged.-release cap. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)28, A6.27. S Anxiety, essential tremor. P H80mg every morning or evening; may be increased if necessary to 160mg daily up to 240mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
CALMAX
Ergha
2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. marked ’apzm 1’ resp. All tabs. oblong, scored. 0.25mg-100, A2.03. 0.5mg-100, A3.92. 1mg-100, A8.18. S Anxiety disorders. P 0.25-0.5mg three times daily. Max. 4mg daily. R 0.25mg two or three times daily. Q Not recommended. D See SPC.
CENTRAX
Parke-Davis
2NO Long acting benzodiazepine. Prazepam 10mg. Blue scored tab. marked W and 10. 60, A3.77. S Anxiety, when the disorder is severe, disabling or subjecting the individual to extreme distress. P Elderly, 5-15mg daily; others, 10-60mg daily in single or divided doses. Duration: Max 4-6 weeks. Q Not recommended. D Myasthenia gravis, severe respiratory/ hepatic insufficiency, sleep apnoea syndrome, acute narrow-angle glaucoma. B Long term use: Tolerance may develop; risk of dependence. Withdraw gradually. Caution: History of alcohol/drug abuse, elderly, children. Contains lactose. May induce anterograde amnesia. Risk of psychiatric and paradoxical reactions, discontinue if occurs. Not recommended for primary treatment of psychotic illness. Should not be used alone to treat depression/anxiety associated with depression (suicide may be precipitated). Driving or using machinery.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
85
3.2 ANXIETY
CNS
DISORDERS
ciprofloxacin, or enoxacine (all contraindicated), other MAOIs (not recommended). Caution: Anticoagulants, St Johnâ&#x20AC;&#x2122;s wort, warfarin, CYP2D6 substrates, other centrally acting and sedative drugs, smoking. A Weight decrease, palpitations, tremor, paraesthesia, blurred vision, tinnitus, yawning, GI disorders, increased sweating, rash, musculoCITROL Rowex skeletal pain, muscle tightness, muscle spasm, decreased appetite, flushing, fatigue, abdominal 2NO pain, erectile dysfunction, insomnia, agitation, SSRI. Citalopram (hydrobromide) 10mg, 20mg, 30mg. 10mg, round tab; 20mg and 30mg, oblong decreased libido, anxiety, abnormal orgasm, biconvex tabs. with one sided score notch marked abnormal dreams. C20 and C30. All white film-ctd. 10mg-28, A10.33; DIAZEMULS Actavis 10mg-30, A11.08; 20mg-28, A16.40; 30mg-28, 2NO A28.00. S Panic disorder with or without Benzodiazepine. Diazepam 5mg/ml. Emulsion for agoraphobia. inj. 10, A7.20. P 10mg once daily for the 1st week, then S Severe anxiety or agitation incl. delirium may be increased to 20mg per day, and up to tremens; acute muscle spasm including that 60mg per day. 1st effects after 2-4 weeks; full associated with tetanus; convulsions and status response after up to 3 months. epilepticus; pre-operative medication in minor R 10mg daily. Max. 30mg daily. surgery. Q Under 18 years, not recommended. P By slow IV inj. (1ml/min), IM inj., or inf. B Risk of suicide until therapeutic effects (min. 4ml/h). Anxiety/agitation: Usually 10mg are achieved. Diabetes, unstable epilepsy, history repeated 4 hourly. Acute muscle spasm: 0.1-0.3mg/ of mania, bleeding disorders, hepatic or severe kg IV repeated every 1-4 hrs as required, or renal impairment. Driving/operating machines. continuous inf. of 3-10mg/kg every 24 hrs. ECT. Lactation, pregnancy (only if essential). Convulsions: 10-20mg IV or IM. Status epilepticus, Withdraw slowly. initially, 0.15-0.25mg/kg IV repeated in 30 to 60 C MAOIs (within 14 days); contraindicated. mins; may be followed by IV inf. of up to 3mg/kg Alcohol, St Johnâ&#x20AC;&#x2122;s Wort, 5-HT agonists, tryptophan; over 24 hrs. Premedication: 0.1-0.2mg/kg IV not recommended. Caution: CYP2D6 substrates, titrated to patient response. Duration max. 8 cimetidine, lithium, desipramine, neuroleptics, weeks for anxiety, 4 weeks for insomnia incl. anticoagulants and drugs increasing bleeding risk tapering off process. (e.g. NSAIDs, antipsychotics, TCAs). R Elderly or debilitated, reduce initial dose A Somnolence, insomnia, agitation, by half. nervousness, headache, tremor, dizziness, Q Convulsions: 0.2-0.3mg/kg IV or IM (or palpitations, nausea, dry mouth, GI disorders, 1mg per year of life). increased sweating, abnormal accommodation, D Myasthenia gravis, severe respiratory asthenia, tachycardia, hypotension, hypertension, insufficiency, sleep apnoea syndrome, severe micturition disorder, polyuria, weight change, hepatic insufficiency. Pregnancy, lactation. rhinitis, sinusitis, sexual disorders, rash, vision or B Chronic respiratory insufficiency, history taste abnormalities. of alcohol or drug abuse. Not recommended: Use in depression, anxiety associated to depression, CYMBALTA Lilly psychotic illness. Children. Tolerance may develop after repeated use. Driving or using machines. 2NO 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, Discontinue gradually. C Alcohol (avoid). Caution: Antipsychotics, 60mg. Opaque caps. White body marked 30mg hypnotics, anxiolytics/ sedatives, antidepressants, with blue cap marked 9543; green body marked narcotic analgesics, anti-epileptics, anaesthetics, 60mg with blue cap marked 9542 resp. 30mg-28, sedative antihistamines, P450 inhibitors. A 20.50; 60mg-28, A 34.15. A Drowsiness, numbed emotions, reduced S Generalised Anxiety Disorder. alertness, confusion, fatigue, headache, dizziness, P Initially 30mg once daily; if insufficient muscle weakness, ataxia, double vision, response increase to 60mg (usual maintenance restlessness, agitation, irritability, aggressiveness, dose). Max. 120mg daily. After consolidation of delusion, rages, nightmares, hallucinations, response, continue treatment for several months. psychoses, inappropriate behaviour. Physical and Discontinue gradually over 1-2 weeks. psychic dependence, anterograde amnesia. PreQ Under 18 years, not recommended. existing depression may be unmasked. Psychiatric D Liver disease resulting in hepatic and paradoxical reactions. impairment, severe renal impairment (ccQ30ml/ Pregnancy, lactation. C Alcohol, not recommended. Caution: Other CNS depressants, cytochrome P450 inhibitors, oral contraceptives. A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision.
min), uncontrolled hypertension. Pregnancy (unless essential), lactation. B History of mania, bipolar disorder, seizures, increased IOP or risk of acute narrowangle glaucoma. Hypertensive crisis reported. Hypertension, cardiac disease; monitor BP at least 1st month. Elderly. Suicidal thoughts; monitor carefully. May occur: Liver injury, incl. severe elevations of liver enzymes, hepatitis and jaundice. Akathisia may develop. Driving/using machines. Contains sucrose. C Non-selective, irreversible MAOIs and potent CYP1A2 inhibitors, eg. fluvoxamine,
86
EFEXOR XL
once daily with food. May be increased to max 225mg/day. Make increments at 2 weeks intervals or more. Maintain lowest effective dose. Panic disorder: Initially 37.5mg/day for the 1st 7 days, then 75mg once daily. Max. 225mg/day if necessary. Increases at 2 week intervals or more. Severe renal impairment: 1/2 dose. Mild-moderate hepatic impairment: 1/2 dose; further reduction may be required in some patients. R Use lowest effective dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.
FRISIUM
sanofi-aventis
2NO Benzodiazepine. Clobazam 10mg. White tab. marked Hoechst one side, scored and coded B/GL on reverse. 100, A9.44. S Acute or chronic anxiety, relief of symptoms associated with anxiety states, phobia and psychosomatic disorders. P Elderly, 20mg; others, 20-30mg. Both daily in divided doses or as a single dose at night. Max. 60mg daily. Duration: 2-4 weeks. Q Under 3 years, not recommended; 3-12 years, up to half adult dose. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, drug or alcohol dependence. Pregnancy, lactation (use only if essential). Children (6 months-3 years) other than in exceptional cases. B Tolerance, dependence, anterograde amnesia, psychiatric and paradoxical reactions may occur. Caution: Pre-existing muscle weakness, spinal/cerebellar ataxia. Elderly, acute respiratory insufficiency, renal/hepatic impairment; reduce dose. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants. A Drowsiness, reduced alertness, numbed emotions, confusion, fatigue, headache, dizziness, muscle weakness, fine tremor, double vision.
GERAX
Gerard
2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White oval scored tab. marked GL 0.25 one side, pink oval scored tab. marked GL 0.50 one side, blue oval scored tab. marked GL1.0 one side resp. All marked G on reverse. 0.25mg-100, A3.51; 0.5mg-100, A6.76; 1mg-100, A14.12.
INDERAL LA
AstraZeneca
3MO Non-cardioselective b-blocker. Propranolol (HCl) 160mg. Lavender/pink hard prolong.-release cap. marked INDERAL LA. 28, A8.41.
3MO ALSO HALF-INDERAL LA Propranolol (HCl) 80mg.
Wyeth Lavender/pink hard prolong.-release cap. marked
2NO 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) 37.5mg, 75mg, 150mg. Resp., opaque peach with opaque light crey caps, opaque peach, opaque dark orange, marked W and strength. All prolonged-release hard caps. 37.5mg-7, A2.39; 75mg-28, A13.70; 150mg-28, A23.10. S Generalised anxiety disorder. Social anxiety disorder. Panic disorder, with or without agoraphobia. P Generalised anxiety/social anxiety: 75mg
HALF-INDERAL LA. 28, A6.13. S Anxiety. P 80mg or 160mg daily. Max. 240mg daily. Q Not recommended.
3MO ALSO INDERAL TABLETS Propranolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, A1.20. P Initially 40mg two or three times daily increasing if necessary at weekly intervals.
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Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
ANXIETY
Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.
LEXAPRO
Lundbeck
2NO SSRI. Escitalopram (oxalate) 5mg, 10mg, 15mg, 20mg. Round white film-ctd tab. marked EK and oval white scored film-ctd tabs. marked with EL, EM and EN, resp. 5mg-28, A14.00; 10mg-28, A22.40; 15mg-28, A33.90; 20mg-28, A44.80. S Major depressive episodes. Generalised anxiety disorder (GAD). Panic disorder with or without agoraphobia. Social anxiety disorder (SAD). Obsessive-compulsive disorder (OCD). P Panic disorder: Initially 5mg for 1st week, may increase to max. 20mg daily. Max. effect reached after 3 months. GAD: 10mg once daily, may increase to max. 20mg. SAD: 10mg once daily. Relief of symptoms 2-4 weeks. Depending on response adjust dose between 5mg-20mg daily. Continue for up to 12 weeks. Depression, OCD: See section 3.4. Reduced hepatic function: Initially 5mg for 2 weeks, may increase to 10mg. R Over 65 years, initially half adult dose and lower max. dose. Q Under 18 years, not recommended. B Hyponatraemia observed with SSRI use. History of mania/hypomania, co-admin. of ECT in patients on SSRI’s, bleeding disorders, coronary heart disease, paradoxical anxiety. Monitor patients with unstable epilepsy, diabetes. Withdraw gradually. Closely monitor patients for suicide and self harm during initiation of therapy (all SSRIs). Driving/using machine. Pregnancy, lactation. C Contra: Non-selective, irreversible MAOIs. Reversible MAOI-A (moclobemide), not recommended. Caution: Selegiline, lithium, tryptophan, St. John’s Wort, drugs lowering epilepsy seizure threshold, oral anticoagulants, cimetidine, substrates or inhibitors of CYP2C19 (eg. omeprazole), CYP2D6 substrates, other serotonergic drugs, alcohol. A Nausea, sweating, somnolence, fatigue, dizziness, insomnia, constipation, diarrhoea, appetite decrease, sexual dysfunction, pyrexia, sinusitis, yawning.
LEXOTAN
Roche
2NO Intermediate-acting benzodiazepine. Bromazepam 1.5mg, 3mg. Slighly yellow cylindrical tab. marked Roche 1.5mg and pink cylindrical tab. marked Roche 3 resp. 1.5mg-30, A2.71. 3mg-30, A3.43. S Short-term treatment of anxiety. P 3-18mg daily. Both in divided doses. R 1.5-9mg daily. Q Not recommended. D Respiratory depression, acute respiratory insufficiency, sleep apnoea syndrome, severe hepatic insufficiency, myasthenia gravis. B Pregnancy, lactation, renal and hepatic impairment. C Alcohol, antipsychotics, hypnotics, anxiolytics/sedatives, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. A Drowsiness, reduced alertness, confusion, fatique, headache, dizziness, muscle weakness, double vision. Amnesia, restlessness, agitation, irritability, aggression, hallucinations, psychosis, dependence. See SPC.
DISORDERS
3.2
A81.70. S Generalised Anxiety Disorder (GAD). P Initial daily dose, 150mg in either two Long-acting benzodiazepine. Chlordiazepoxide or three divided doses; may be increased to 5mg, 10mg. Green/yellow cap. and green/black 300mg, 450mg, and to max. 600mg/day with 1cap resp. Both marked LIB and cap. strength 5mg- week intervals. Discontinue gradually over a min. 100, A5.37; 10mg-100, A7.47. of 1 week. Renal impairment: Adjust dosage (see S Short-term treatment of anxiety that is SPC). severe, disabling or subjecting the individual to Q Under 18 years, not recommended. unacceptable distress; symptoms of acute alcohol D Pregnancy (unless essential), lactation. withdrawal; control of muscle spasm. B Withdrawal symptoms may occur. P Anxiety: Up to 30mg daily; max. 100mg Driving/using machines. Contains lactose. daily. All in divided doses. Alcohol withdrawal: 25- C Caution: Ethanol, lorazepam, 100mg repeated if necessary in 2-4 hours. antidiabetics (adjust dose). R Do not exceed half adult dose. A Dizziness, tiredness. Increased appetite, D Myasthenia gravis, severe respiratory weight gain, euphoric mood, confusion, change in insufficiency, sleep apnoea, severe hepatic libido, irritability, attention disturbances, insufficiency. Pregnancy, lactation. clumsiness, memory impairment, tremor, speech B Tolerance, physical dependence. Caution: difficulty, paraesthesia, visual disturbances, Alcohol/drug abuse (or history of). Withdraw vertigo, dry mouth, GI disorders, erectile gradually. Do not exceed 4 weeks without careful dysfunction, peripheral oedema, drunken feeling, re-evaluation. Anterograde amnesia, psychiatric abnormal gait. reactions may occur. Caution: Children (duration kept to min.). Elderly. Not for treatment of STELAZINE Goldshield psychotic illness. Driving/operating machinery. 2MO C Not recommended: Alcohol. Caution: Phenothiazine group III. Trifluoperazine (HCl) 1mg, CNS depressants, CYP450 inhibitors. 5mg. Blue sug-ctd tabs. marked SKF. 1mg-112, A Drowsiness, numbed emotions, reduced A 2.75; 5mg-112, A3.92. alertness, confusion, fatigue, headache, dizziness, 2MO muscle weakness, ataxia, double vision. ALSO STELAZINE SYRUP Trifluoperazine (HCl) LUSTRAL Pfizer 1mg/5ml. 200ml, A1.93. S Anxiety states, depressive symptoms 2NO secondary to anxiety, agitation. SSRI. Sertraline (HCl) 50mg, 100mg. White, capP 2-4mg daily in divided doses. Max. 6mg shaped, film-ctd tabs. marked PFIZER and ZLT-50 daily. or ZLT-100 resp. 50mg tab. scored. 50mg-28, Q Under 6 years, not recommended; 6-12 A12.63. 100mg-28, A18.94. years, up to 4mg daily. All in divided doses. S Panic disorder with or without D Comatose states, bone marrow agoraphobia. Social anxiety disorder. Postdepression, liver damage, existing blood dyscrasia. traumatic stress disorders. Uncontrolled cardiac decompensation. P Initially, 25mg daily increasing to 50mg B Elderly. CVD. Parkinsonism. Pregnancy, daily after 1 week. Dose may be increased in lactation. Epilepsy. 50mg increments over a period of weeks, to max. A See SPC. 200mg daily. Q Not recommended. STESOLID Actavis D Significant hepatic insufficiency. 2NO Pregnancy, lactation. Unstable epilepsy or Benzodiazepine. Diazepam 2mg, 4mg per ml. convulsant disorders. Rectal soln. in 5mg and 10mg tubes. 5mg-5, B Monitor for suicidality during 1st few A5.39; 10mg-5, A6.75. weeks of treatment. Discontinue if patient enters S Acute severe anxiety and agitation, a manic phase. Controlled epilepsy. ECT, not epileptic and febrile convulsions, tetanus, as recommended. Driving or using machines. sedative in minor surgical and dental procedures, C Contraindicated: MAOIs (or within 14 or when rapid effect required but IV inj. days), pimozide. Monitor alcohol, lithium, impracticable. warfarin, phenytoin, sumatriptan. Caution: St P 10mg. Repeat dose if no response John’s wort, diazepam, tolbutamide, cimetidine, within 5 mins. TCAs, other centrally acting drugs, other R 5mg. Repeat dose if no response within serotonergic drugs. 5 mins. A Anorexia, insomnia, dizziness, Q 1-3 years, 5mg; over 3 years, 10mg. somnolence, tremor, GI disorders, increased Repeat dose if no response within 5 mins. sweating, ejaculatory delay. D Acute pulmonary insufficiency, respiratory depression, sleep apnoea syndrome. Pregnancy, lactation. B Should not be used in phobic or obsessional states, chronic psychosis, bereavement. Not to be used alone for depression or anxiety LYRICA Pfizer associated with depression. Caution: Personality 2MO disorders, renal or hepatic dysfunction, chronic GABA analogue. Pregabalin 25mg, 50mg, 75mg, pulmonary insufficiency, closed-angle glaucoma. 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., Elderly or debilitated patients. Amnesia, marked Pfizer on cap., and PGN and strength on withdrawal symptoms may occur. Do not drive or body. 25mg-56, A81.70; 84, A122.55; 50mg-84, operate machines. A122.55; 75mg-56, A81.70; 100mg-84, A122.55; C CNS depressants (avoid), alcohol. 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, A Drowsiness, light-headedness,
LIBRIUM
Meda
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
87
3.3 PSYCHOSES
CNS
Severe hepatic impairment, history of seizure disorder or conditions associated with seizures, diabetes mellitus, CVD, cerebrovascular disease, predisposition for hypotension or hypertension, nightmares) 2NO family history of QT prolongation, risk of C Alcohol, CNS depressants. Nonbenzodiazepine anxiolytic. Hydroxyzine HCI aspiration pneumonia. Monitor for signs of A Amnesia, drowsiness, depression, 25mg. White, oblong, film-ctd biconvex scored pychiatric and paradoxical reactions, dependence. hyperglycaemia, tardive dyskinesia, neuroleptic tabs. 25, A1.31. malignant syndrome. Not approved for dementia2NO 3.3 PSYCHOSES related psychosis. Driving/using machines. ALSO UCERAX SYRUP Hydroxyzine HCI 10mg/5ml. Hypersensitivity reactions may occur. Clear to slightly yellow syrup (2 flavours). 200ml, ABILIFY BMS C Caution: Potent inhibitors of CYP2D6 A2.75. 2NO (eg. quinidine, fluoxetine, paroxetine) or CYP3A4, S Anxiety/tension states, psychomotor potent CYP3A4 inducers, certain antihypertensives, Atypical antipsychotic. Aripiprazole 5mg, 10mg, agitation and acute stress situations e.g. minor 15mg, 30mg. Rect. and blue, rect. and pink, round drugs causing QT prolongation, alcohol or other surgical procedures or allergic states. Pruritus due CNS drugs. and yellow, round and pink tabs., marked A-007 to allergic conditions e.g. chronic urticaria, atopic/ and 5, A-008 and 10, A-009 and 15, A-011 and 30 A Somnolence, dizziness, headache, contact dermatitis, histamine-mediated pruritus. resp. 5mg-28, A123.79; 10mg-28, A128.41; 15mg- akathisia, nausea, vomiting, restlessness, insomnia, P Anxiety: 50mg daily in 3 doses of anxiety, extrapyramidal disorder, akathisia, tremor, 28, A128.41; 30mg-28, A256.82 12.5mg-12.5mg-25mg. More severe cases, up to dizziness, somnolence, sedation, blurred vision, GI S Schizophrenia (adults and adolescents 300mg daily. Pruritus: Initially 25mg before disorders, fatigue. q 15 years). Treatment of moderate to severe resting, then if necessary up to 25mg, 3-4 times manic episodes in Bipolar I Disorder and daily. Max.: Single dose, 200mg; daily dose, Clonmel prevention of new manic episodes in patients who CLONACTIL 300mg. Hepatic dysfunction, reduce daily dose by experienced predominantly manic episodes and 2MO 33%. whose manic episodes responded to aripiprazole. Phenothiazine group I. Chlorpromazine (HCl) R Initially, half recommended dose. P 10 or 15mg (10 or 15ml) once daily; 25mg, 50mg, 100mg. White film-ctd tabs. marked Q Over 6 years: 1mg/kg up to 2mg/kg Maintenance, 15mg daily. Max. 30mg daily. with tab. name and strength. 25mg-250, A6.18; daily in divided doses. R Consider lower starting dose. 50mg-250, A9.03; 100mg-250, A15.13. D Pregnancy and lactation. Porphyria. Q Under 15 years, not recommended. Over S Anxiety and tension states; B Caution: Glaucoma, bladder outflow 15 years, schizophrenia: Initially 2mg for 2 days schizophrenia and other psychoses. Terminal illness obstruction, decreased GI motility, myasthenia titrated to 5mg for 2 additional days to reach and intractable hiccup. gravis, dementia. Increased potential for recommended daily dose (10mg). May be P Anxiety, agitation and psychoses: 75convulsions; known predisposing factor to cardiac increased in 5mg increments to max 30mg daily. 300mg daily, taken in divided doses. Psychoses, arrhythmia or concomitant treatment with 2 N O potentially arrhythmogenic drugs. Young children, dose may be up to 1g daily. Intractable hiccup: 10elderly, moderate/severe renal impairment (reduce ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. 25mg 6 to 8 hourly, increasing to 25-50mg 6-8 Orodispersible round tab. marked with strength dose). Stop at least 5 days before allergy testing. hourly if necessary. Terminal illness: 10-25mg, 4-6 on one side and A over 640 or 641 resp. on Contains ethanol, sucrose. Driving or using hourly. reverse. 10mg, pink; 15mg, yellow. 10mg-28, machines. R Agitated states: 10-25mg once or twice A141.12; 15mg-28, A141.12. C Avoid: MAOIs, alcohol. Barbiturates, daily. Other conditions: 1/3 to 1/2 usual adult dose S Schizophrenia. Treatment of moderate other CNS depressants, anticholinergics, with gradual titration upward. to severe manic episodes in Bipolar I Disorder and Q Anxiety, agitation and psychoses: 1-5 betahistine, anticholinesterases, phenytoin, prevention of new manic episodes in patients who cimetidine, CYP2D6 substrates. years, 0.5mg/kg every 4-6 hours to max 40mg/day. experienced predominantly manic episodes and 6-12 years,1/3 to 1/2 of adult dose to max of VALIUM Roche whose manic episodes responded to aripiprazole. 75mg/day. Terminal illness: 0.5mg/kg every 4-6 2NO hours. 1-5 years: Max 40mg/day. 6-12 years: Max 2NO ALSO ABILIFY ORAL SOLUTION Aripiprazole 1mg/ 75mg/day. Long-acting benzodiazepine. Diazepam 5mg. 1ml. Bottle. 150 ml, A137.36 D Coma due to CNS depressants. Scored yellow tab.and marked with 5 and ROCHE. S Schizophrenia. Moderate to severe Lactation. Use with other potentially haemotoxic 5mg-100, A1.08. manic episodes in Bipolar I Disorder and drugs. S Anxiety; acute alcohol withdrawal; short prevention of new manic episodes in patients who B Risk of: Angle-closure glaucoma, urinary term treatment of insomnia where daytime experienced predominantly manic episodes and retention, dyskinesias, neuroleptic malignant sedation is acceptable. Night terrors and whose manic episodes responded to aripiprazole. syndrome. History of jaundice, existent liver somnambulism in children. 2N dysfunction or blood dyscrasias. Long term use, P 3-30mg daily in divided doses. ALSO ABILIFY SOLUTION FOR INJECTION monitor regularly. Caution: High doses, elderly, R 3-15mg daily. Aripiprazole 7.5mg/ml. Clear, colourless, aqueous extremes of temperature, CVD, parkinsonism, Q See SPC. sln for inj. epilepsy. Patients with risk factors for ventricular D See SPC. S Rapid control of agitation and disturbed arrhythmias. Establish accurate diagnosis if using XANAX Pharmacia behaviours in patients with schizophrenia or in to relieve severe vomiting. Pregnancy. Contains patients with manic episodes in Bipolar I Disorder, lactose. Driving or using machines (if drowsiness 2NO when oral therapy is not appropriate. Treatment occurs). Medium-acting benzodiazepine. Alprazolam with aripiprazole solution for inj. should be C CNS depressants, antihypertensives, 0.25mg, 0.5mg, 1mg. White, pink and lavender discontinued as soon as clinically appropriate and anticholinergics, MAOIs, analgesics, antioval scored tabs. marked UPJOHN 29, UPJOHN 55 use of oral aripiprazole should be initiated. Parkinsonian drugs. Drugs which prolong QT and UPJOHN 90 resp. 0.25mg-100, A2.11; 0.5mgP For IM use. Initially, 9.75mg (1.3 ml), as interval. Deferoxamine, lithium, oral 100, A4.06; 1mg-100, A8.48. a single IM inj. Effective dose range: 5.25-15mg as hypoglycaemics, insulin. Antacids (admin. 2 hours S Anxiety when the disorder is severe, a single inj. A lower dose of 5.25 mg (0.7 ml) may apart). disabling or causing extreme distress. be given, according to clinical status. A 2nd inj. A Postural hypotension, anticholinergic P 0.5-1mg daily in divided doses, may be admin 2 hrs after the 1st inj. Max 3 inj. in effects, drowsiness, thermoregulation disorders, increasing in increments not greater than 1mg 24 hr. Max daily dose 30mg (incl. all formulations weight gain, hyperglycaemia, changes in glucose every 3-4 days to 3-4 daily. Max. treatment of aripiprazole). tolerance, tachycardia, QT interval prolongation, duration, 8-12 weeks. R Consider lower starting dose. allergic skin reactions, rash, photosensitivity, R 0.25mg twice daily. Q Under 18 yrs, not recommended. haematological disorders. Q Not recommended. D Pregnancy (unless benefit outweighs D Myaesthenia gravis, severe respiratory risk), lactation. CLOPIXOL Lundbeck or hepatic insufficiency sleep apnoea syndrome. B Monitor for suicidal behaviour particularly after initiation or switching of therapy. 2 N O B Tolerance, physical and psychic pendence, anterograde amnesia, psychiatric and paradoxical reactions (e.g restlessness, agitation,
unsteadiness, ataxia.
UCERAX
88
UCB irritability, aggressiveness, delusion, rages,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
Treat today for tomorrow ABILIFY® is indicated for the treatment of schizophrenia in adults and in adolescents* 15 years and older. ABILIFY® is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. ABILIFY® (aripiprazole) PRESCRIBING INFORMATION. TABLETS, ORODISPERSIBLE TABLETS, ORAL SOLUTION AND SOLUTION FOR INJECTION. See Summary of Product Characteristics before prescribing. PRESENTATION: Tablets: 5mg, 10mg, 15mg, 30mg aripiprazole; orodispersible tablets (ODT): 10mg, 15mg aripiprazole; oral solution (OS): 1mg/ml aripiprazole, solution for injection for intramuscular use (IM): 7.5mg/ml aripiprazole (1.3ml vial containing 9.75mg aripiprazole). INDICATIONS: Oral formulations: Adults: Schizophrenia. Moderate to severe manic episodes in Bipolar I Disorder & prevention of new manic episodes in aripiprazole respondent patients. Paediatric patients: Schizophrenia in adolescents 15 years and older. IM: Rapid control of agitation & disturbed behaviours in schizophrenia or manic episodes in Bipolar I Disorder. DOSAGE: Oral formulations: Adults: Schizophrenia: Usual starting dose is 10 or 15mg once daily with or without food. Effective dose range is 10 to 30mg with a recommended maintenance dose of 15mg. Mania in Bipolar I Disorder: Usual starting dose is 15mg once daily with or without food as monotherapy or combination therapy. For recurrence prevention, continue at same dose. Dose adjustment on basis of clinical status. Paediatric patients: Schizophrenia: Recommended dose is 10 mg/day once daily with or without food. Treatment to be initiated at 2mg (using ABILIFY Oral Solution 1 mg/ml) for two days, titrated to 5mg for two more days to reach recommended daily dose of 10 mg. Effective dose range is 10 to 30 mg/day. IM: Initial dose 9.75mg (1.3ml) injection. Effective dose range: 5.25 to 15 mg as single injection. Lower dose of 5.25 mg (0.7 ml) may be given. Second injection may be administered two hours after the first, on basis of individual clinical status. No more than three injections in any 24-hour period. For all formulations (adult and paediatric patients): Maximum daily dose 30mg. No dosage adjustment required in renal or mild to moderate hepatic impairment. Elderly (≥ 65 years): Efficacy not established. Consider lower starting dose. Not recommended for use in paediatric patients below 15
*indicated in oral formulations only
years of age: Safety and efficacy not established. CONTRAINDICATIONS: Hypersensitivity to any ingredient. WARNINGS AND PRECAUTIONS: Clinical improvement may take several days to some weeks: monitor patient throughout this period. Reduce dose or discontinue if signs of tardive dyskinesia appear. Discontinue if patient develops signs and symptoms indicative of neuroleptic malignant syndrome. Caution in patients with a history of seizure, cardiovascular disorders, conduction abnormalities, diabetes and elderly demented patients with psychosis and those at risk of aspiration pneumonia (see SPC). Do not use in pregnancy unless benefit outweighs risk; breastfeeding not advised. Until individual patient response established, caution not to drive or operate machinery. IM: observe patients for orthostatic hypotension and regularly monitor blood pressure, pulse, respiratory rate and level of consciousness. If additional parenteral benzodiazepine therapy is deemed necessary, monitor patients for excessive sedation and for orthostatic hypotension. DRUG INTERACTIONS: Increased hypotensive effect with certain antihypertensives. Caution is advised when combining with alcohol or other CNS medication with overlapping side effects such as sedation; also with certain antifungals, antituberculous drugs, antivirals, anticonvulsants, St John’s Wort and medicines known to cause QT prolongation or electrolyte imbalance. Reduce aripiprazole dose with concomitant use of potent CYP3A4 or CYP2D6 inhibitors, e.g. fluoxetine, paroxetine. Increase aripiprazole dose with concomitant use of potent CYP3A4 inducers, e.g. carbamazepine. See SPC. IM: increased sedation when combined with lorazepam. UNDESIRABLE EFFECTS: In adult placebocontrolled trials, the following adverse drug reactions were reported: Tablets, ODT, OS, IM common (> 1/100 < 1/10): somnolence, dizziness, headache, akathisia, nausea, vomiting: Tablets, ODT, OS common: restlessness, insomnia, anxiety, extrapyramidal disorder, tremor, sedation, blurred vision, dyspepsia, constipation, salivary hypersecretion, fatigue; Tablets ODT, OS, IM uncommon:
(> 1/1000 < 1/100): tachycardia, orthostatic hypotension; IM: uncommon (> 1/1000 < 1/100): increased diastolic blood pressure, fatigue, dry mouth.; Tablets, ODT, OS: uncommon (> 1/1000 < 1/100): depression. In adolescent (13-17 years) placebo-controlled trials, the adverse drug reactions reported were similar to those for adults. The following adverse drug reactions were reported more frequently than for adults: very common (≥ 1/10): somnolence, sedation, extrapyramidal disorder; common (≥ 1/100 < 1/10): dry mouth, increased appetite, orthostatic hypotension. Other adverse events from postmarketing surveillance include; allergic reaction (anaphylaxis & angioedema), pancreatitis, priapism, suicide, rhabdomyolysis, hyperglycaemia, diabetes, dysphagia, convulsions, cardiac disorders including arrhythmias & sudden unexplained death, thromboembolic events, hypertension, hepatitis, leukopenia and thrombocytopenia. Symptoms of dystonia may occur in susceptible individuals during the first few days of treatment, with an elevated risk of acute dystonia observed in males and younger age groups. Other findings, see SPC. OVERDOSAGE: Treatment should be symptomatic and supportive: adequate airway maintenance, cardiovascular monitoring and close medical supervision. Activated charcoal reduces serum concentrations. LEGAL CATEGORY: POM. AUTHORISATION NUMBERS: 28 tablets: 5mg (EU/1/04/276/002), 10mg (EU/1/04/276/007), 15mg (EU/1/04/276/012), 30mg (EU/1/04/276/017). 28 orodispersible tablets: 10mg (EU/1/04/276/025), 15mg (EU/1/04/276/028). 150mL bottle 1mg/ml oral solution: (EU/1/04/276/034). 1.3ml vial 7.5mg/ml solution for injection: (EU/1/04/276/036). MARKETING AUTHORISATION HOLDER: Otsuka Pharmaceutical Europe Ltd, Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU. ADDITIONAL INFORMATION AVAILABLE ON REQUEST FROM: Bristol-Myers Squibb Pharmaceuticals, South County Business Park, Leopardstown, Dublin 18. Tel: 1-800-749-749. DATE OF P.I. PREPARATION: October 2009 (II-48).
570IE09PM043
3.3 PSYCHOSES
CNS
alcohol, CNS depressants, antihistamines, lithium, MAOIs, anticholinergics. Drugs effecting hepatic enzymes, highly protein bound drugs, cimetidine, phenytoin, adrenaline, drugs with hypotensive or respiratory depressant effects, fluvoxamine. A Neutropenia leading to life threatening agranulocytosis. Drowsiness, fatigue, hypersalivation, tachycardia, dizziness, headache, 2NO urinary retention and incontinence, transient ALSO CLOPIXOL INJECTION Zuclopenthixol tremor, akathisia, rigidity, NMS rarely, postural decanoate 200mg/ml oily inj. Amp. 10 x 1ml, hypotension, hypertension, weight gain, isolated A34.96. P Usually 200-400mg by deep IM inj. every skin reactions, autonomic effects. GI upset. ECG changes, myocarditis. Seizures, confusion, 2-4 weeks. Max. 600mg a week. restlessness, agitation, delirium. Circulatory Q Not recommended. collapse, respiratory depression or arrest, 2NO ALSO CLOPIXOL-CONC. Zuclopenthixol decanoate aspiration, dysphagia, hyperglycaemia, rarely CPK increase. 500mg/ml oily inj. Amp. 5 x 1ml, A42.02. P 250-500mg by deep IM inj. every one to DENZAPINE Merz four weeks. 2N Q Not recommended. 2NO Dibenzodiazepine. Clozapine 25mg, 50mg, 100mg, 200mg. 25mg, 50mg, 100mg: Round flat yellow ALSO CLOPIXOL ACUPHASE Zuclopenthixol acetate 50mg/ml. 1ml, 2ml amps. 5 x 1ml, A26.06. bevel edged tabs marked with strength over a pressure sensitive breakline. 200mg: Large, ovalS Initial treatment for acute psychoses, shaped yellow tab. with strength on one side and incl. mania or exacerbation of chronic psychosis. a breakline on the other. 25mg-84, A40.00; 50mgP 50-150mg deep IM inj. repeated if 50, A47.62; 100mg-84, A160.00; 200mg-50, necessary after 2 or 3 days. A190.48. Q Not recommended. D Comatose states, apathy or withdrawal, 2 N pregnancy, lactation. ALSO DENZAPINE ORAL SUSPENSION Clozapine, B Intolerance to oral neuroleptic drugs, 50mg/ml. Free-flowing yellow susp. 100ml, A95.24. S Treatment-resistant schizophrenia in Parkinson’s disease, renal, hepatic, cardiovascular patients unresponsive to or intolerant of or respiratory disease. Elderly may need dose conventional neuroleptics. Psychotic disorders reduction. occurring during the course of Parkinson’s disease, C See SPC if standard treatment has failed. CLOZARIL Novartis P Schizophrenia: Initially 12.5mg once or twice on first day increasing by 25-50mg 2N increments up to 300mg daily within 2-3 weeks; Dibenzodiazepine. Clozapine 25mg, 100mg. may be further increased in 50-100mg increments Yellow, circular, scored tabs marked L/O and Z/A at half-weekly or, preferably, weekly intervals. resp. on one side and SANDOZ on reverse. 25mgUsual range: 200-450mg/day given in divided 84, A57.03; 100mg-84, A228.12. doses. Max. 900mg daily. Parkinson’s: Initially S Treatment-resistant schizophrenia in 12.5mg/day in the evening. Increase by 12.5mg patients unresponsive to or intolerant of increments, with max. 2 increments a week up to conventional neuroleptics. Commence therapy in 50mg once daily. Usual range: 25-37.5mg/day. hospital. Max. 50mg/day, exceptionally 100mg/day. P Initially 12.5mg once or twice on first R Initially 12.5mg daily increasing day increasing slowly up to 300mg daily within 14- gradually in increments of 25mg daily. 21 days, max. 900mg daily. After max. benefit Q Not recommended. achieved titrate down to maintenance dose. See D Patients unable to undergo regular SPC. blood tests. History of granulocytopenia/ R Initially 12.5mg daily increasing agranulocytosis (except if from chemotherapy). gradually in increments of 25mg daily. Impaired bone marrow function. Uncontrolled Q Not recommended. epilepsy. alcoholic and other toxic psychoses, drug D History of drug induced neutropenia/ intoxication, comatose conditions. Circulatory agranulocytosis or myeloproliferative disorders. collapse and/or CNS depression. Severe renal or Alcoholic and toxic psychoses, drug intoxication, cardiac disorders. Active liver disease associated comatose states, uncontrolled epilepsy, circulatory with nausea, anorexia or jaundice; progressive collapse, CNS depression, severe hepatic or renal liver disease, hepatic failure. Paralytic ileus. disease. Lactation. Lactation. B Patients must register with CPMS. B Can cause agranulocytosis. Initiation Monitor leucocyte counts weekly during first 18 restricted to WBC countq3500/mm3 and weeks and every 2 weeks thereafter; withdraw neutrophil count q 2000/mm3). Monitor these immediately if wbc count below 3 x 109/l and/or counts weekly for first 18 weeks and at least 49 neutrophil count below 1.5 x 10 /l. Patients should week intervals thereafter including 4 weeks after report symptoms of infection. Pregnancy; complete discontinuation (see SPC). Discontinue adequate contraception must be used. Monitor immediately if neutropenia or agranulocytosis. patients with a history of epilepsy. Prostatic Caution: CVD or family history of QT hypertrophy, narrow angle glaucoma, paralytic prolongation, risk factor for stroke, liver disorders, ileus. Liver disease. Orthostatic hypotension, prostatic enlargement, narrow-angle glaucoma. cardiovascular, renal or hepatic disorders, transient Reported: Myocarditis, pericarditis/ pericardial temperature elevations. effusion, cardiomyopathy, impairment of intestinal C Other drugs which cause peristalsis, neuroleptic malignant syndrome, hyperglycaemia, thromboembolism. Withdraw agranulocytosis, narcotics, benzodiazepines, Thioxanthene. Zuclopenthixol (HCl) pink tab.;10mg light brown tab.; 25mg brown tab. All film-ctd tabs. 10mg-100, A8.70; 25mg-100, A17.40. S Psychoses, especially schizophrenia. P Initially 20-30mg daily in divided doses. Maintenance, 20-60mg daily. Max. 150mg daily. Q Not recommended.
90
gradually over 1-2-weeks. Pregnancy. Driving/using machines. Contains lactose. C Contra: Drugs causing agranulocytosis (co-trimoxazole, chloramphenicol, sulphonamides, pyrazolone analgesics e.g. phenylbutazone, penicillamine, carbamazepine, cytotoxic agents); avoid depot antipsychotics, drugs causing electrolyte imbalance, drugs prolonging QT, alcohol. Caution: CNS depressants, drugs with anticholinergic, hypotensive, or respiratory depressant effects, norepinephrine, epinephrine, CYP1A2 inhibitors (caffeine) and inducers (omeprazole), smoking, fluvoxamine, paroxetine, carbamazepine, phenytoin, rifampicin, CNS-active agents. See SPC. A Leucopoenia/decreased WBC/ neutropenia, eosinophilia, leukocytosis, weight gain, drowsiness, dizziness, blurred vision, headache, tremor, rigidity, akathisia, extra pyramidal symptoms, seizures, tachycardia, ECG changes, hypertension, postural hypotension, syncope, GI disorders, dry mouth, elevated liver enzymes, urinary incontinence/ retention, fatigue, fever, temperature regulation disturbances.
DEPIXOL
Lundbeck
2NO Thioxanthene. Flupenthixol decanoate 20mg/ml oily inj. Amps. 10 x 1ml, A18.01.
2NO ALSO DEPIXOL CONC. INJECTION 100 MG/ML Flupenthixol decanoate 100mg/ml oily inj. Amps. 10 x 1ml, A74.21. S Schizophrenia and other psychoses, particularly in patients who are withdrawn or apathetic. P 20-40mg or more as required every two to four weeks. Give by deep IM inj. Q Not recommended.
2NO ALSO DEPIXOL 200MG Flupenthixol decanoate 200mg/ml oily inj. Amp. 5 x 1ml, A115.11. P 50-200mg by deep IM inj. Repeat usually every two to four weeks. Max. 400mg weekly. Q Not recommended. D Comatose states, pregnancy, lactation, excitation or overactive patients. B Intolerance to oral neuroleptic drugs, Parkinson’s disease, renal, hepatic, cardiovascular or respiratory disease. Elderly may need dose reduction. C See SPC.
DOLMATIL
Sanofi
2MO Substituted benzamide. Sulpiride 200mg white scored tab. marked D200; 400mg white scored stick-shaped film-ctd tab. 200mg-100, A24.45; 400mg-100, A42.51. S Acute and chronic schizophrenia. P Over 14 years, initially 400-800mg daily in two divided doses (morning and evening). Adjust to 100-1200mg twice daily according to required response. See SPC. Q Under 14 years, not recommended. D Phaeochromocytoma. B Hypomania. Hypertension. Renal impairment. Epilepsy. Pregnancy. C See SPC.
GEODON
Pfizer
2NO 5-HT2A and dopamine (D2) receptor antagonist.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS Ziprasidone (as HCl monohydrate) 20mg blue/ white cap. 40mg blue cap. 60mg white cap. 80mg blue/white cap. All marked with Pfizer and ZDX 20, ZDX 40, ZDX 60 or ZDX 80. 20mg-56, A104.01; 40mg-56, A109.48; 60mg-56, A120.43; 80mg-56, A158.75. S Schizophrenia. P Acute treatment, 40mg twice daily with food. Max. 80mg twice daily. Maintenance, lowest effective dose, 20mg twice daily may be sufficient. Hepatic insufficiency: Consider lower dose. Q Not recommended. D Known QT-interval prolongation, congenital long QT syndrome. Recent MI, uncompensated HF. Pregnancy, lactation. B Bradycardia, electrolyte disturbances. If cardiac symptoms occur, a cardiac evaluation should be performed. Neuroleptic malignant syndrome and torsade de pointes have been reported rarely. Tardive extrapyramidal syndrome after long-term treatment, reduce dose or discontinue. History of seizures, hepatic impairment. Patients with risk factors for stroke. Contains lactose. Ability to drive or operate machinary my be impaired. Women of child bearing potential should use contraception. C Contra: Class IA and III antiarrhythmics, arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, dolasetron mesylate, mefloquine, sertindole, cisapride, drugs that prolong the QT interval. Caution: CNS drugs, alcohol, ketoconazole, carbamazepine. A Restlessness, dystonia, akathisia, extrapyramidal disorder, parkinsonism, tremor, dizziness, sedation, somnolence, headache, vision blurred, GI disorders, musculoskeletal rigidity, asthenia, fatigue.
PSYCHOSES 3.3 thyrotoxicosis, phaeochromocytoma, hepatic/renal dysfunction, epilepsy or predisposing conditions, severe cardiovascular disease, hyperthyroidism, risk factors for stroke. May occur: Hypotension, hypertension (less common). C Contra: Other QT prolonging drugs. Caution: Alcohol, hypnotics, sedatives, strong analgesics, lithium, levodopa, methyldopa, adrenaline and other sympathomimetic agents, adrenergic blocking agents (e.g. guanethidine), tricyclic antidepressants, cytochrome P450 inhibitors (esp. ketoconazole, paroxetine), CYP2D6 inhibitors, quinidine, buspirone, fluoxetine, anticonvulsants, carbamazepine, phenobarbital, rifampicin, phenodione. A Agitation, insomnia, depression, psychotic disorder, extrapyramidal disorder, hyperkinesia, headache, tardive dyskinesia, oculogyric crisis, dystonia, dyskinesia, akkathisia, bradykinesia, hypokinesia, hypertonia, masked facies, somnolence, tremor, dizziness, visual disturbance, orthostatic hypotension, hypotension, GI disorders, abnormal liver function test, rash, urinary retention, erectile dysfunction, inj. site reaction, increased/decreased weight.
A Headache, akathisia, dizziness, dystonia, extrapyramidal disorder, hypertonia, parkinsonism, sedation, somnolence, tremor, AV block 1st degree, bradycardia, bundle branch block, sinus tachycardia, tachycardia, orthostatic hypotension, GI disorders, asthenia, fatigue, weight increased.
MODECATE
BMS
2NO Depot phenothiazine group III. Fluphenazine decanoate 25mg/ml oily inj. Multi-dose vial. 10ml x 1, A28.00. S Maintenance treatment of psychotic disorders particularly schizophrenia.
2NO
ALSO MODECATE CONCENTRATE Fluphenazine decanoate 100mg/ml oily inj. Amps. 0.5ml x 10, A58.21; 1ml x 5, A56.89. P Initially 12.5mg by deep IM inj. into gluteal region to test susceptibility to extrapyramidal reactions, then adjust dose according to response. Usual dosage range, 12.5100mg every two to five weeks. See SPC. Elderly patients, initial test dose of 6.25mg, then same as adult. Q Not recommended. INVEGA Janssen-Cilag D Comatose states, phaeochromocytoma, 2MO marked cerebral atherosclerosis, renal or hepatic Other antipsychotics. Paliperidone 3mg, 6mg, 9mg. failure, severe cardiac insufficiency, severely Trilayer cylindrical-shaped longitudinal prolonged- depressed states, blood dyscrasias. release tabs. 3mg, white marked PAL 3; 6mg, B Caution: Liver disease, cardiac beige marked PAL 6; 9mg, pink marked PAL 9. arrhythmias, CVD, family history of 3mg-28, A125.92; 6mg-28, A132.36; 9mg-28, QTprolongation or narrow angle glaucoma, A170.46. thyrotoxicosis, severe respiratory disease, epilepsy, S Treatment of schizophrenia. Parkinson’s disease, elderly, hypothyroidism, P 6mg once daily, in the morning. Range: myasthenia gravis, prostatic hypertrophy, very hot 3-12mg once daily. Always take in fasting state or weather, surgery. Perform blood count and liver always take with breakfast and do not alternate function tests (1st few months). Pregnancy, the two. Adjust dose only after clinical lactation. Driving/ using machines. HALDOL DECANOATE Janssen-Cilag between reassessment. Swallow tab. whole with liquids. C Avoid: Other antipsychotics, QT 2NO Mild renal impairment: 3mg once daily; increase if prolonging drugs and drugs causing elecrolyte Butyrophenone. Haloperidol (as decanoate) 50mg/ necessary. Moderate renal impairment: 3mg once imbalance. Large doses of hypnotics (contra). daily. Severe renal impairment: 3mg every other ml, 100mg/ml. Slightly amber, slightly viscous oily Caution: Alcohol, sedatives, strong analgesics, bday, may increase to once daily after clinical sln for IM inj. in 1ml amps. 50mg/ml-5, A25.88; blockers, thiazide diuretics, ACE-inhibitors, reassessment. 100mg/ml-5, A34.30. sympathomimetics, L-dopa, anti-convulsants, S Long term management of behavioural Q Under 18 years, no experience. anticoagulants, MAOIs, TCAs, antidepressants, D Pregnancy (unless clearly necessary), disorders, schizophrenia, hypomania and mania lithium, antidiabetics, corticosteroids, digoxin, lactation. and allied conditions. neuromuscular blocking agents, anti-Parkinsonians, P Initially 50mg every 4 weeks by deep IM B Known CVD or family history of QT anticholinergics, quinidine and other antiprolongation. Neuroleptic Malignant Syndrome/ inj. May be increased to 200mg every 4 weeks in arrythmics. tardive dyskinesia reported (discontinue). Monitor A Parkinsonian-like states. Lethargy, 50mg increments. Higher doses may be given if diabetics (and patients with risk factors). necessary. blurred vision, dry mouth, nasal congestion, R Start with low doses 12.5-25mg every 4 Cerebrovascular disease, conditions that predispose constipation, urinary disorders, mild hypotension, to hypotension. History of seizures. Potential for weeks increasing according to response. cognitive disorders, epileptiform attacks, rash, GI obstruction; only use in patients who are able Q Not recommended. hypothermia, oedema. to swallow the tab. whole. Conditions with D Comatose states. Parkinson’s disease and/or lesion of the basal ganglia. CNS depression decreased GI transit time (caution). Renal NOZINAN sanofi-aventis impairment, dose adjustment may be required; due to alcohol or other depressant drugs. 2NO Clinically significant cardiac disorders, QTc interval ccQ10ml/min, not recommended. Severe hepatic Phenothiazine group I. Levomepromazine (HCl) prolongation, history of ventricular arrhythmia or impairment, not recommended. Elderly patients 2.5%. Sln for inj. or inf. 10 x 1ml, A14.25. with dementia (particularly with risk factors for Torsades de pointes, bradycardia or 2nd or 3rd S Schizophrenia, other major psychoses stroke). Parkinson’s disease, dementia with Lewy degree heart block, uncorrected hypokalaemia. bodies. Risk of priapism (seek urgent medical care incl. mania and hypomania. As adjunct in the Pregnancy, lactation. if not resolved within 3-4 hours). Conditions which relief of severe terminal pain with accompanying B To exclude unexpected adverse may elevate core body temperature. An antiemetic anxiety, restlessness or distress. sensitivity, start patients on oral haloperidol. P 12.5-25mg IM or IV after dilution, every effect may occur; which may mask overdosage/ Baseline ECG recommended prior to treatment 6 to 8 hrs. Severe cases, up to 50mg every 6 to 8 esp. in elderly and patients with positive personal other conditions. 3mg tab. contains lactose. C Not recommended: Risperidone. Caution: hrs. Alternatively 25-200mg daily, diluted with or family history of cardiac disease or abnormal Drugs prolonging QT interval, other centrally cardiac clinical findings; ECG monitoring during saline by continuous SC infusion. acting drugs or alcohol, levodopa and other therapy may be needed. Reduce dose if QT Q Not recommended. prolonged; discontinue if QTc q 500ms. Rare cases dopamine agonists, other agents that induce D Coma (particularly if associated with orthostatic hypotension or lower the seizure of sudden death reported in patients on other CNS depressants). Closed angle glaucoma threshold or that affect GI transit time. antipsychotic drugs (incl. haloperidol). Cardiac risk. Risk of urinary retention related to Carbamazepine, rifampicin and St John’s wort effects reported very rarely. Caution: Risk factors urethroprostatic disorders. History of for ventricular arrhythmias (assess risk vs benefit), (dose re-evaluation needed). agranulocytosis. Lactation. Pregnancy (only use if AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
91
3.3 PSYCHOSES
CNS
60, A124.64; 6mg-30, A100.88. S Schizophrenia. Maintenance treatment in order to prevent relapse in chronic schizophrenia in responsive patients. Aggression and pronounced psychotic symptoms in patients with dementia in whom such disorders can cause suffering, potential danger or risk of self-harm in the patient. Manic episodes in association with bipolar disorder. Serious acting out conduct disorders such as behavioural disorder and oppositional defiant disorder according to DSM IV in patients with psychological development disorders. Serious conduct disorders in children and adolescents with autism. P Swallow tabs with water. Acute and chronic treatment of schizophrenia: Taken once daily or twice daily. Initially 2 mg/day. May be increased to 4mg/day on day 2. Usual range: 4mg6mg/day. Caution doses q 10mg daily. Max: 16mg/day. Serious conduct disorders: r50kg: Initially 0.5mg daily; increase as required by 0.5mg daily every other day. Optimal dose: 1mg daily; range 0.5mg-2mg once daily. Q50kg: Initially 0.25mg daily. Dose can be increased as required by 0.25mg daily every other day. Optimal dose: 0.5mg daily; range 0.25mg-2mg once daily. Aggression and pronounced psychotic symptoms in patients with dementia: Initially 0.25mg twice daily. Increase as required by 0.25mg twice daily every other day. Optimal dose: 1mg daily. Some patients may need 2mg daily. When optimal dose obtained, consider a once daily dose. Manic episodes in association with bipolar disorder: Initially 2mg once daily. May increase as required by 1mg daily at 24 hour intervals. Optimal dose: 16mg/day. Impaired renal function: Half starting dose and titrate slower. ORAP Janssen-Cilag R Acute and chronic treatment of schizophrenia: Initially 0.5mg twice daily. May 2MO increase by 0.5mg twice daily to 1-2mg twice Diphenylbutylpiperidine. Pimozide 4mg. Green daily. Manic episodes in association with bipolar scored tab. marked 0/4 one side, JANSSEN on disorder: Initially 0.5mg twice daily. Adjust reverse. 100, A36.48. individually to 1-2 mg twice daily. S Management of schizophrenia and Q Acute and chronic treatment of allied psychoses incl. monosymptomatic schizophrenia: Under 15 years, not recommended. hypochondriacal psychoses. Serious conduct disorders: As per adults. Under 5 P Schizophrenia and allied psychoses: years of age, limited data. Autism: Initially 0.25mg/ Initially 2-4mg daily, maintenance 2-12mg daily day for patients Q 30kg and 0.5mg/day for depending on individual response. Max. 20mg patients r 30kg. Day 4, may increase as required daily. Elderly, half starting dose. by 0.25mg for patients Q 30kg and 0.5mg for Q Not recommended. patients r 30kg. Maintain dose and evaluate on D Patients with pre-existing congenital QT day 14. Dosage can be increased at 2-weekly prolongation and patients with history of cardiac intervals by 0.25mg for patients Q 30 kg and 0.5 arrhythmias. mg for patients r 30 kg. Maximum dosage in B Endogenous depression. Parkinsonism, clinical studies did not exceed 1.5mg for patients epilepsy. Cardiovascular disorders. Pregnancy, Q 30 kg, 2.5 mg for patients r 30 kg or 3.5 mg lactation. for patients q 45 kg. See SPC. Under 5 years of C Inhibitors of CYP3A4 and CYP2D6 (eg. age, limited data. Manic episodes: Under 18 years, quinidine), drugs prolonging QT interval eg. no data. certain anti-arrhythmics, TCAs, maprotiline, D Pregnancy (unless essential), lactation. phenothiazines, sertindole, astemizole, B Caution: Cardiovascular disorders, Lewy terfenadine, cisapride, bepridil, halofantrine and body dementia or Parkinson’s disease, epilepsy. sparfloxacin; all contra. Drugs causing electrolyte Tardive dyskinesia may develop. Neuroleptic disturbances (avoid). Caution: Anticholinergics, malignant syndrome may occur. Reduce/ levodopa. discontinue if excitation, agitation and aggression occur. Elderly, hepatic and renal impairment. PERDAMEL Clonmel Elderly patients with dementia (weigh the risks 2NO against the benefits; avoid dehydration). Non Selective monoaminergic antagonist. Risperidone drug-related hyperprolactinaemia, prolactin0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red/ dependent tumours. Diabetics and patients with white/salmon/yellow/ light green or yellow film-ctd risk factors. Withdraw gradually. There is a lack of tabs, resp. All marked R and strength. All (except experience of preventative long-term treatment of 6mg) oblong and scored. 6mg, round, not scored. bipolar disorder. Contains lactose. Driving, using 0.5mg-20, A8.36; 1mg-20, A10.86; 1mg-60, machines. A32.55; 2mg-60, A64.23; 3mg-60, A94.44; 4mgC Avoid: Alcohol. Caution: Centrally acting essential). B Should not be used in PD (except special cases). Caution: Liver dysfunction, blood dyscrasias, history of jaundice, stroke risk factors, elderly, dementia, severe hepatic/renal insufficiency, cardiovascular disease, risk factors for thromboembolism. May occur: Extrapyramidal side effects, dyskinesia, akathisia, dystonia, tardive dyskinesia, neuroleptic malignant syndrome. Dose dependent QT interval prolongation. Hypotension. Lowers seizure threshold in epilepsy. Avoid alcohol. Surveillance for eye changes. May interfere with thermoregulation. Driving/using machinery. C Contra: Dopaminergic agonists (except in Parkinson’s disease), sultopride, benzamide neuroleptic. Not recommended: Alcohol, levodopa, class Ia anti-arrhythmics, class III anti-arrhythmics, phenothiazines, benzamides, butyrophenones, pimozide, bepridil, cisapride, diphenmanil, erythromycin IV, mizolastine, vincamine IV, halofantrine, moxifloxacin, pentamidine, sparfloxacin. Caution: Antihypertensives, atropine and atropine-like substances, guanethidine, CNS depressants, drugs metabolised by cyt. P450 2D6, alkaline solutions. A Postural hypotension, anticholinergic effects, sedation/drowsiness, indifference, anxiety reactions, mood changes, early-onset dyskinesia, extrapyramidal syndrome, tardive dyskinesia, hyperprolactinemia, alteration in temperature regulation, weight gain, hyperglycemia, glucose tolerance alteration, allergic skin reactions, photosensitisation, leucopenia, hyperleucocytosis/ granulocytopenia (discontinue), brownish deposits in anterior eye segment.
92
drugs, other antipsychotics, lithium, antidepressants, antiparkinson agents, drugs that have a central anticholinergic effect, alphablocking sympatholytics, methyldopa, reserpine, centrally acting antihypertensive agents, guanethidine, levodopa and other dopaminergic agonists, carbamazepine. Potent CYP2D6 inhibitors. Drugs prolonging QT-interval. Drugs that may cause electrolyte disturbances. Furosemide in elderly patients with dementia. A Agitation, anxiety, insomnia, headache, sedation, weight gain.
RESDAL
Niche
2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg. Round, slightly convex, pink marbled orodispersible tablets. 0.5mg-28, A7.45; 1mg-28, A16.03; 2mg-28, A32.11. S Treatment of schizophrenia. Maintenance treatment in order to prevent relapse in chronic schizophrenia in responsive patients. P Initially 2mg daily; may increase dose to 4mg on day 2. Usual optimal dose: 4-6mg daily. Doses q10mg daily did not increase therapeutic effect. Over 16mg, not recommended. If sedation required benzodiazepine can be administered concomitantly. Renal disorders: Initially 1 mg/day with slow titration to optimal dose (v adult doses). Moderate to severe hepatic impairment: Caution. R Initially 0.5mg twice daily. Maintain or adjust individually with 0.5mg twice daily increments up to 1-2mg twice daily. Q Over 15 years, as per adults. Under 15 years, not recommended. D Pregnancy (unless benefits outweigh risk), lactation. B Elderly patients with dementia: Avoid dehydration, increased risk of cerebrovascular events (assess risks against benefits). May cause orthostatic hypotension (consider dose reduction). Possible induction of tardive dyskinesia. Neuroleptic malignant syndrome may occur. Caution: Lewy body dementia, Parkinson’s disease, epilepsy, family history of QT prolongation, known cardiovascular disease, non drug-related hyperprolactinaemia, prolactin-dependent tumours, diabetes (or at risk patients). Driving/ using machines. Contains: Phenylalanine (aspartame), sorbitol. C Avoid alcohol. Caution: Drugs acting on CNS including other antipsychotics, lithium, antidepressants, antiparkinson agents and active substances with a central anticholinergic effect, levodopa and other dopaminergic agonists, carbamazepine or other hepatic enzyme inducing drugs, phenothiazines, TCAs and certain bblockers, strong CYP2D6 inhibitors , cimetidine, ranitidine, drugs prolonging QT-interval or causing electrolyte disturbances. A Agitation, anxiety, insomnia, headache and sedation, weight gain.
RISPAL
Pinewood
2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg, 3mg. Resp. red-brown, white, peach, yellow round biconvex film-ctd tabs. 0.5, 1 and 2mg scored. 0.5mg-20, A8.75; 1mg-60, A34.08; 2mg-60, A67.24; 3mg-60, A98.90. S Schizophrenia and other psychoses: Acute and chronic, in which positive and/or negative symptoms are prominent; affective
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS symptoms; maintenance in responsive patients. Bipolar disorder: Short-term treatment of acute mania or mixed episodes, as monotherapy or in combination with lithium or valproate. Severe behavioural disturbances in: Patients with dementia; adults/children with impaired social functioning; children with autism/ developmental disorders. P Schizophrenia: Take once or twice daily. Initially, 2mg/day; may be increased to 4mg/day on day 2. Usual range: 4-6mg/day. Caution with dose q10mg/day. Max. 16mg/day. 1st episode, may benefit from lower doses and slower titration. Renal and liver disease: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 12mg twice daily. Bipolar mania: Once daily. Range 2-6mg/day. Monotherapy, start 2mg; may be increased by increment of max 1mg per 24 hrs. Adjunctive therapy, start 2mg; may be increased by increment of max 2mg/day every other day. Dementia: Initially 0.25mg twice daily adjusted by increments of 0.25mg twice daily every other day if needed. Optimum dose 0.5mg twice daily; may be increased up to 1mg twice daily. When target dose is reached, a once daily dosing regimen can be considered. Disruptive behaviour disorders: r50kg, initially 0.5mg once daily, adjusted by increments of 0.5mg once daily every other day, if needed. Optimum dose 1mg once daily; range 0.51.5mg once daily. R50kg, initially 0.25mg once daily, adjusted by increments of 0.25mg once daily every other day, if needed. Optimum dose 0.5mg once daily; range 0.25-0.75mg once daily. R Schizophrenia: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 1-2mg twice daily. Q Schizophrenia: Under 15 years, not recommended. Autism: 5 years and over, see SPC. Disruptive behaviour,: See adult dose; limited experience under 5 years. D Pregnancy (unless benefit outweighs risk), lactation. B Renal, hepatic, CVD, epilepsy, dementia, elderly. May occur: Orthostatic hypotension, tardive dyskinesia, extrapyramidal symptoms, neuroleptic malignant syndrome (discontinue), hyperglycaemia, possible weight gain. Contains lactose. 0.5mg, 2mg and 3mg tabs contain sunset yellow. Driving/operating machinery. C Caution: CNS acting drugs, levodopa and other dopamine agonists, carbamazepine or other hepatic enzyme inducing drugs, CYP2D6 inhibitors (e.g.fluoxetine, paroxetine), furosemide (patients with dementia). A Insomnia, agitation, anxiety, headache, mild and transient sedation.
PSYCHOSES 3.3 ALSO RISPERDAL LIQUID Risperidone 1mg/ml. Liquid. 100ml plus pipette, A50.53. S Schizophrenia. Moderate to severe manic episodes associated with bipolar disorders. Short-term treatment (up to 6 weeks) of persistent aggression in with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and at risk or harm to self or others. Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children r 5 years with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, requiring pharmacologic treatment. P Schizophrenia: Take once or twice daily. Initially, 2mg/day; may be increased to 4mg/day on day 2. Usual range: 4-6mg/day. Caution with dose q10mg/day. Max. 16mg/day. Some patients may benefit from lower doses and slower titration. Bipolar mania: Once daily. Range 2-6mg/day. Initally 2mg/day; may be increased by increment of max 1mg per 24 hrs. Dementia: Initially 0.25mg twice daily adjusted by increments of 0.25mg twice daily every other day if needed. Optimum dose 0.5mg twice daily; may be increased up to 1mg twice daily. Renal/hepatic impairment: Half dose; slower dose titration. R Schizophrenia/bipolar mania: 0.5mg twice daily; may be adjusted with 0.5mg twice daily increments to 1-2mg twice daily. Q Schizophrenia: Under 18 years, not recommended. Disruptive behaviour disorders: q50kg, initially 0.5mg once daily, adjusted by increments of 0.5mg once daily every other day, if needed. Optimum dose 1mg once daily; range 0.51.5mg once daily. Q50kg, initially 0.25mg once daily, adjusted by increments of 0.25mg once daily every other day, if needed. Optimum dose 0.5mg once daily; range 0.25-0.75mg once daily.
2NO
ALSO RISPERDAL CONSTA Risperidone 25mg, 37.5mg, 50mg prolonged release. Susp. for inj. 25mg-1, A120.28; 37.5mg-1, A173.65; 50mg-1, A226.86. S Maintenance treatment of schizophrenia in patients stabilised with oral antipsychotics. P 25mg every 2 weeks (alternate buttocks); consider 37.5mg if stabilised on more than 4mg/day oral. Consider increase after 4 weeks. Max. 50mg every 2 weeks. Ensure prior tolerability with oral risperidone. suppl. with oral risperidone for first 3 weeks as appropriate. Hepatic and renal impairment, caution, 25mg every 2 weeks if min 2mg oral tolerated following titration. See SPC. R 25mg every 2 weeks plus oral cover as RISPERDAL Janssen-Cilag above. 2NO Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. Selective monoaminergic antagonist. Risperidone B Caution: Elderly, diabetics, 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red, white, orange, yellow, green oblong film-ctd tabs. hyperprolactinaemia, seizures. Higher incidence of cerebrovascular adverse events. May occur: marked Ris/0.5, Ris/1, Ris/2, Ris/3 and Ris/4 resp. Orthostatic hypotension, tardive dyskinesia, 6mg:Yellow, round film-ctd tab. marked Ris/6. neuroleptic malignant syndrome (esp. Parkinson’s 0.5mg-20, A5.72; 1mg-20, A7.43; 60, A22.28; 2mg-60, A43.96; 3mg-60, A64.64; 4mg-60, disease, dementia with Lewy bodies), QT A85.31; 6mg-28, A69.05. prolongation, priapism, disruption of body 2NO temperature regulation. Contains lactose and aspartame. ALSO RISPERDAL QUICKLET Risperidone 1mg, C Antiarrhythmics class Ia and III, TCA, 2mg, 3mg, 4mg. 1mg, 2mg: Light coral, square some antihistaminics, other antipsychotics, some biconvex tabs. marked R1, R2 resp. 3mg, 4mg: antimalerials (chinice, mefloquine), medicines Coral, round biconvex tabs. marked R3, R4 resp. causing electrolyte imbalance, centrally acting 1mg-28, A13.40; 2mg-28, A25.24; 3mg-28, A73.72; 4mg-28, A94.95. drugs, levodopa, dopamine agonists, carbamazepine or other hepatic enzyme-inducing 2NO
drugs, CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine), verapamil, phenothiazines, some bblockers, furosemide (elderly dementia patients). A Increased blood prolactin, increased weight, tachycardia, parkinsonism, headache, akathisia, dizziness, tremor, dystonia, somnolence, sedation, lethargy, dyskinesia, blurred vision, dyspnoea, epistaxis, cough, nasal congestion, GI disorders, enuresis, rash, erythema, arthralgia, back pain, pain in extremity, increased/decreased appetite, pneumonia, influenza, bronchitis, upper RTIs, UTIs, pyrexia, fatigue, peripheral oedema, asthenia, chest pain, insomnia, anxiety, agitation, sleep disorder.
RISPERGER
Gerard
2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg, 3mg. Resp. reddish-brown, white, orange and yellow circular biconvex filmctd tab with break-line. 0.5mg-20, A9.45; 1mg-20, A12.38; 2mg-60, A73.20; 3mg-60, A107.01. S Treatment of schizophrenia; maintenance in responsive patients. Aggression and pronounced psychotic symptoms in patients with dementia. Manic episodes associated with bipolar disorder. Behavioural disorders according to DSM-IV in children (q5 years), adolescents and adults. Serious conduct/behavioural disorder in children with autism aged 5-12 years; continued treatment of adolescents with autism where treatment was started in childhood. P Schizophrenia: Initially 2mg/day, may be increased to 4mg/day from the 2nd day; adjust to individual response. Optimal dose: 4-6mg/day. Doses q10mg/day show no additional antipsychotic effects. q16mg/day, safety not established. Behavioural disorders: q50kg: initially 0.5mg daily, can be increased as required by 0.5mg daily every other day. Optimal dose: 1mg/ day, max: 1.5mg once daily. Q50kg: Initially 0.25mg daily, can be increased by 0.25mg daily every other day. Optimal dose: 0.5mg daily, max: 0.75mg once daily. Dementia: Initially 0.25mg twice daily, may be increased by 0.25mg twice daily every other day. Optimal dose: 1mg daily. Bipolar mania: Initially, 2mg/day, may be increased by 1mg daily. Optimal dose: 1-6mg daily. R Schizophrenia: Initially 0.5mg twice daily, can be increased by 0.5mg twice daily to 12mg twice daily. Other indications: As per adults. Q Schizophrenia: Not recommended under 15 years. Behavioural disorders: As per adults. Autism: Initially 0.25mg/day for patients Q20kg; 0.5mg for patients q20kg. Maintain and evaluate dose on day 14 of treatment. Dosage can be increased at 2-weekly intervals by 0.25mg and 0.5mg for patients Q20kg and q20kg respectively. See SPC. D Pregnancy, lactation. B Caution: Hepatic/renal impairment, elderly, Lewy body dementia, Parkinson’s disease, epileptics, elderly patients with dementia (avoid dehydration), pronounced brachycardia, cardiovascular disease, hereditary long QT syndrome, hyperprolactinaemia, prolactindependent tumours, diabetics (or at risk patients). May occur: Orthostatic hypotension (consider dose reduction), tardive dyskinesia, neuroleptic malignant syndrome (discontinue), exacerbation of excitation, agitation and aggression. Contains lactose and sunset yellow. Driving/operating machinery. C Avoid alcohol. Caution: CNS acting drugs, other antipsychotics, lithium,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
93
3.3 PSYCHOSES
CNS 1mg-20, A10.84; 60, A32.48; 2mg-60, A64.10; 3mg-60, A94.26; 4mg-60, A124.42; 6mg-28, A100.68.
symptoms. P Initially, 4mg once daily; increase by increments of 4mg after 4-5 days on each dose until optimal daily maintenance dose of 12-20mg 2NO ALSO RISPONE ORAL SOLUTION Risperidone 1mg/ reached. Consider max. 24mg only exceptionally. Q Under 18 years, not recommended. ml. Clear colourless sln. 100ml, A44.22. D History of CVD, CHF, cardiac S Treatment of schizophrenia. hypertrophy, arrhythmia, or bradycardia (Q50 Maintenance of schizophrenia in responsive patients. Moderate to severe manic episodes. Soln beats/min). Congenital long QT syndrome (or family history), or acquired QT interval and 0.5mg tab: Severe behavioural disturbances prolongation (QTc q 450msec in males and associated with aggressiveness and self-inflicted 470msec in females). Hypokalaemia, injury diagnosed according to DSM-IV criteria in hypomagnesaemia. Severe hepatic impairment. patients with mental retardation. RISPEVA Teva P Swallow tabs. with water. Schizophrenia: Pregnancy, lactation. B Monitor ECG before and during Take once or twice daily. Initially 2mg daily. May 2NO treatment (see SPC); discontinue if QTc prolonged increase to 4mg on day 2. Usual optimal dose: 4Selective monoaminergic antagonist. Risperidone q 500msec. Tardive dyskinesia, Neuroleptic 0.5mg, 1mg, 2mg, 3mg, 4mg. Brownish-red, round 6mg daily. Caution with dose q10mg/day. Max. Malignant Syndrome reported (discontinue). tab. marked R on one side and with score line on 16mg/day. Manic episodes: Initially 2mg once History of seizure, elderly, risk factor for stroke or daily. Adjust dose if indicated at intervals of 24 the other (0.5mg). White (1mg), pale brown diabetes, mild/moderate hepatic impairment hours. Recommended dose: 2-6mg daily. Daily (2mg), yellow (3mg) or pale green (4mg) round, (slower titration and lower maintenance dose). dose q 6mg, no data. Behavioural disturbances: bevelled biconvex film-ctd tabs, scored and Withdraw gradually. Contains lactose. Driving/ marked with RIS above the score line and strength Patients Q 50kg: Initially 0.25mg once daily; can under the score line on one side. 0.5mg-20, A8.59; be increased by 0.25mg once daily no sooner than using machines. C Contra: Potent CYP3A inhibitors, drugs every 2nd day. Usual maintenance dose, 0.5mg 1mg-20, A11.15; 60, A33.42; 2mg-60, A65.94; (0.25-0.75mg) once daily. Patients r 50kg: Initially prolonging QT interval eg. class Ia and III 3mg-60, A96.98; 4mg-60, A127.98. 0.5mg once daily; can be increased by 0.5mg once antiarrhythmics, thioridazine, erythromycin, S Treatment of schizophrenia; terfenadine, astemizole, gatifloxacin, moxifloxacin, daily no sooner than every 2nd day. Usual maintenance of improvement in patients who cisapride, lithium. Caution: CYP2D6 inhibitors e.g. maintenance dose, 1mg (0. 5-1.5mg) once daily. have shown initial response. Moderate to severe fluoxetine, paroxetine, CYP3A inducers. Hepatic/renal impairment: Half starting/ manic episodes in BD patients. A Rhinitis/nasal congestion, abnormal P Schizophrenia: Take once or twice daily. maintenance dose, slower titration. ejaculation, dizziness, dry mouth, postural Initially 2mg daily. May increase to 4mg on day 2. R Schizophrenia and manic episodes: hypotension, weight gain, peripheral oedema, Initially 0.5mg twice daily. Adjust individually with Usual optimal dose: 4-6mg daily. Caution with dyspnoea, paraesthesia, prolonged QT interval. 0.5mg twice daily increments to 1-2mg twice daily. dose q10mg/day. Max. 16mg/day. Manic episodes: Red/white blood cells urine positive. Initially 2mg once daily. Adjust dose if indicated at Q Schizophrenia: Under 15 years, not intervals of min. 24 hours. Recommended dose: 2- recommended. Manic episodes: Under 18 years, SERENACE Teva not recommended. Behavioural disturbances: 6mg daily. Daily dose q 6mg, no data. Hepatic/ Under 5 years, not recommended. 2NO renal impairment: Initially 0.5mg twice daily. D Pregnancy (unless benefit outweighs Adjust individually with 0.5mg twice daily CAPSULES. Butyrophenone. Haloperidol 0.5mg. risk), lactation. Soln: Hyperprolactinaemia (not increments up to 1-2mg twice daily. Two-tone, green hard gelatine cap. marked drug induced). R Both conditions: Initially 0.5mg twice NORTON 500 on one half, Serenace on the other. B Elderly with dementia (avoid daily. Maintain or adjust individually with 0.5mg 30, A0.71. dehydration). Dementia patients with history of twice daily increments up to 2mg twice daily. 2NO CVA, TIA, hypertension or diabetes. Can cause Q Schizophrenia: Under 15 years, not orthostatic hypotension (consider dose reduction). ALSO SERENACE TABLETS Haloperidol 1.5mg, recommended. Manic episodes: Under 18 years, Long term treatment: Tardive dyskinesia can occur. 5mg, 10mg, 20mg. White, bright pink, pale pink, not recommended. dark pink, resp., biconvex tabs marked NORTON Neuroleptic malignant syndrome may occur. D Pregnancy (unless benefit outweighs followed by strength resp. on one side and Caution: Hepatic/renal impairment, elderly, lewy risk), lactation. SERENACE on reverse. 1.5mg-30, A1.22; 5mg-30, body dementia or Parkinson’s disease, epileptics, B Elderly with dementia (avoid A2.27; 10mg-30, A4.58; 20mg-30, A13.32. diabetics, CVD or family history of QT dehydration). Dementia patients with history of 2 NO prolongation, prolactin-dependent tumours, CVA, TIA, hypertension or diabetes (avoid). Can ALSO SERENACE ORAL SOLUTION Haloperidol exposure to extremes of temperature. Psychocause orthostatic hypotension (consider dose organic disturbances, increased risk of undesirable 2mg/ml. 100ml, A7.35; 500ml, A36.76. reduction). Tardive dyskinesia, neuroleptic S Schizophrenia, mania, hypomania, effects. Patients at risk for aspiration pneumonia. malignant syndrome may occur. Caution: Hepatic/ Tabs contain lactose. Driving/using machines. paranoid psychosis, agitation, psychotic illness, renal impairment, elderly, lewy body dementia or C Avoid alcohol, antipsychotics. Caution: childhood behaviour disorders, severe motor tics, Parkinson’s disease, epilepsy, diabetes, CVD, Centrally acting drugs, lithium, antidepressants, Gilles de la Tourette syndrome, intractable hiccup, prolactin-dependent tumours. Contains lactose. anti-parkinsonian drugs, drugs with central severe nausea/vomiting except hyperemesis Driving/ using machine. anticholinergic effect, levodopa and other gravidarum. Caps are also indicated as adjunct in C Avoid alcohol. Caution: CNS acting dopaminergic agonists, carbamazepine or other anxiety states. drugs, other antipsychotics, lithium, hepatic enzyme inducing drugs, strong CYP2D6 P Initially 1.5-20mg daily, increasing as antidepressants, anti-parkinsonian drugs, central inhibitors, diuretics, antacids, cimetidine, required for control, then decreasing for anticholinergics, levodopa and other dopaminergic ranitidine, drugs prolonging QTc interval. maintenance, usually 3-10mg daily. Gilles de la agonists, carbamazepine or other hepatic enzyme A Insomnia, agitation, anxiety, headache, Tourette: Initially 2mg daily increasing to 6-50mg inducing drugs, strong CYP2D6 inhibitors, sedation, weight increase. followed by gradual reduction to maintenance cimetidine, ranitidine, drugs prolonging QTaround 4mg. interval or causing electrolyte disturbances. SERDOLECT Lundbeck R Half dose. A Insomnia, agitation, anxiety, headache, 2 N O Q Initially 0.025-0.05mg/kg daily to max. sedation. 10mg. Maintenance 0.05mg/kg. Limbic selective antipsychotic. Sertindole 4mg, 12mg, 16mg, 20mg. Oval biconvex tabs. marked S D Comatose states. Parkinson’s disease. RISPONE Rowex and strength. Yellow, beige, rose, pink resp. 4mg- Pregancy (unless essential). Lactation. Tabs: 2NO 30, A35.13; 12mg-28, A92.99; 16mg-28, A106.95; Clinically significant cardiac disorders, QTc Selective monoaminergic antagonist. Risperidone prolongation, history of ventricular arrhythmia or 20mg-28, A120.49. 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Red, white, Torsades de pointes. Uncorrected hypokalaemia. S Schizophrenia in patients intolerant to pink, yellow, dark pink, yellow oblong scored B Great Caution: Basal ganglial lesions, at least one other antipsychotic. Do not use in emergency situations for urgent relief of (6mg, twice) film-ctd tabs. resp. 0.5mg-20, A8.37; thyrotoxicosis. Hepatic/ renal dysfunction, epilepsy,
antidepressants, anti-parkinson agents, central anticholinergics, phenoxybenzamine, labetalol and other a-blocking sympatholytics, methyldopa, reserpine and other centrally acting antihypertensive agents, guanethidine, levodopa and other dopamine agonists, carbamazepine or other hepatic enzyme inducing drugs, strong CYP2D6 inhibitors, cimetidine, ranitidine, drugs prolonging QT-interval or causing electrolyte disturbances. A Agitation, anxiety, insomnia, headache, sedation, weight gain.
94
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS CVD, family history of QT prolongation. Tabs: Perform baseline ECG (reduce dose if QT prolonged and discontinue if QTc q500ms), monitor electrolyte periodically. Driving/using machines. Tardive dyskinesia with long-term treatment. High dose: Rarely sudden death, impaired body temp. control, malignant neuroleptic syndrome, hyperthermia, autonomic dysfunction, rigidity, coma. Withdraw gradually. Tabs and caps contain lactose. 20mg tabs contain E124. C Avoid other antipsychotics. Caution: CNS depressants, QT prolonging drugs, lithium (maintain Q1mmol/l), methyldopa, sympathomimetics. A Headaches, dizziness, feeling drowsy/ dulled, anxiety, insomnia, hypotension, dystonia, GI disturbances, anorexia, blurred vision, tachycardia, abnormal liver function, jaundice, urinary retention, photosensitisation, hypersensitivity reactions.
PSYCHOSES 3.3 C Contra: CYP3A4 inhibitors (eg. HIVprotease inhibitors, azole antifungals, erythromycin, clarithromycin, nefazodone). Caution: Hepatic inducers (eg. carbamazepine, phenytoin), other centrally acting drugs, alcohol, thioridazine. Avoid grapefruit juice. A Leucopenia, hyperprolactinaemia, increased appetite, abnormal dreams and nightmares, dizziness, somnolence, headache, syncope, tachycardia, blurred vision, orthostatic hypotension, rhinitis, GI disorders, withdrawal symptoms, mild asthenia, peripheral oedema, irritability, decreased neutrophil count, weight gain. Elevations in: ALT, AST serum triglyceride, total cholesterol, blood glucose. Decrease in HDL cholesterol.
SOLIAN
Sanofi
2MO
Benzamide. Amisulpride 50mg, 100mg, 200mg, 400mg. White to off white, round, breakable tab. engraved AMI and strength on one side. 50mg-60, SEROQUEL XR AstraZeneca A 20.09; 100mg-60, A40.12; 200mg-60, A73.33; 2NO 400mg-60, A160.48. Dibenzothiazepine. Quetiapine (fumarate) 50mg, S Acute and chronic schizophrenia, 200mg, 300mg, 400mg. Prolonged released tabs. including patients with predominant negative Peach, yellow, pale yellow and white resp. marked symptoms. A with XR and strength. 50mg-60, 63.08; 200mgP Acute episodes, 400-800mg daily. 60, A140.80; 300mg-60, A213.89; 400mg-60, Predominant negative symptoms, 50-300mg daily. A282.13. Doses R400mg admin once daily, q400mg in 2 S Treatment of schizophrenia and divided doses. Renal insufficiency, reduce dose to prevention of relapse. half or third (see SPC). P Admin. at least 1 hr before meal. Initial Q Contra-indicated (up to puberty). titration: 300mg (day 1), 600mg (day 2). D Prolactin-dependent tumours. Recommended dose, 600mg/day. Dose range 400- Phaeochromocytoma. Children (up to puberty). 800mg/day. Maintenance, same dose. Switch from Lactation. tabs at equiv. daily dose. Hepatic impairment: B Neuroleptic Malignant Syndrome Initially 50mg/day; can be increased in increments (discontinue). Caution: Diabetes/risk of diabetes, of 50mg/day. severe renal insufficiency, epilepsy, parkinson’s R Initially 50mg/day; can be increased in disease, QT prolongation risk factors, stroke risk increments of 50mg/day to an effective dose. factors, elderly with dementia, risk factors for Q Children and adolescents, not evaluated. thromboembolism. Risk of serious ventricular 2NO arrhythmias. Gradual withdrawal advisable. ALSO SEROQUEL Quetiapine (fumarate) 25mg, Driving/operating machines. Pregnancy. Contains 100mg, 200mg, 300mg. Film ctd tabs. Peach, lactose. yellow, white and white resp. 25mg-60, A37.77; C Contra: Medications which prolong QT 100mg-60, A107.92; 200mg-60, A123.04; 300mginterval or induce torsade de pointes, levodopa. 60, A200.04. Not recommended: Alcohol, bradycardia-inducing S Treatment of schizophrenia. medications, medications inducing electrolyte P Admin. twice a day. Initial titration: imbalance (in particular those causing 50mg (day 1), 100mg (day 2), 200mg (day 3), hypokalaemia), neuroleptics. Caution: CNS 300mg (day 4). Usual effective dose after day 4, depressants, antihypertensives, hypotensive 300-450mg/day. Dose range 150-750mg/day. medications, dopamine agonists. Hepatic impairment: Initially 25mg/day; should be A Extrapyramidal symptoms, acute increased in increments of 25-50mg/day. dystonia, insomnia, anxiety, agitation, orgasmic R Dose titration may need to be slower dysfunction, GI disorders, raised plasma prolactin, and daily therapeutic dose lower. hypotension, weight gain. Q Children and adolescents, not recommended. STELAZINE Goldshield B Monitor for suicidal tendencies, esp. at 2MO beginning. Caution: Hepatic impairment, Trifluoperazine (HCl) 1mg/5ml. 200ml, A1.93. cardiovascular or cerebrovascular disease, S Schizophrenia, psychosis, severe hypotension, history of seizures, patients at risk psychomotor agitation, dangerous impulsive for aspiration pneumonia. Monitor diabetic behaviour. patients. May increase metabolic risk. May occur: Tardive dyskinesia, neuroleptic Monitor for suicidal P Initially 5mg twice daily, increasing after 7 days to 15mg daily. If required increase further tendencies, esp. at beginning. Caution: Hepatic by 5mg at three-day intervals, then reduce to impairment, cardiovascular or cerebrovascular maintenance dose. See SPC. Up to 25mg. disease, hypotension, history of seizures, patients at risk for aspiration pneumonia. Monitor diabetic R Reduce by at least half. Q Up to 5mg daily in divided doses. See patients. May increase metabolic risk. May occur: lit. Tardive dyskinesia, neuroleptic malignant D Comatose states, bone marrow syndrome, lipid changes. Driving/operating depression, liver damage, existing blood dyscrasis. machines. Pregnancy (only if benefit outweighs risk), lactation (avoid). XR tab. contain lactose. Uncontrolled cardiac decompensation.
B Elderly. CVD. Parkinsonism. Pregnancy, lactation. Epilepsy. C See SPC.
STEMETIL
sanofi-aventis
2MO Phenothiazine group III. Prochlorperazine mesylate 5mg white tab. and 5mg white scored tab. Both marked with tab. name and strength. 5mg-250, A11.09. S Minor mental and emotional disturbances. Acute and chronic psychoses especially schizophrenia. P Minor mental disturbances, 15-20mg daily in divided doses increasing to max. 40mg daily. Schizophrenia, 75-100mg daily. See SPC. Q Not applicable.
2NO ALSO STEMETIL INJECTION Prochlorperazine mesylate 1.25%. Amps. 10 x 1ml, A4.03; 10 x 2ml, A5.08. P 12.5-25mg by deep IM inj. two or three times daily. Transfer to oral therapy as soon as possible. Q Not applicable. D Comatose states. Bone marrow depression. Liver damage. B CVD. Parkinsonism. Pregnancy, lactation. C See SPC
ZYPADHERA
Lilly
2J Thienobenzodiazepine. Olanzapine (as palmoate monohydrate) 210mg, 300mg, and 405mg. Reconstituted suspension contains 150mg/ml olanzapine. Yellow solid powder and clear, colourless to slightly yellow solvent for prolonged release susp. for inj. 210mg-1, A266.89; 300mg-1, A408.59; 405mg-1, A533.79. S Maintenance treatment of adults with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine. P For IM use only. Establish tolerability and response with oral olanzapine, then determine dose depending on oral olanzapine dose: 10mg/day: Initially, 210mg/2 weeks or 405mg/4 weeks; maintenance: 150mg/2 weeks or 300mg/4 weeks. 15mg/day: Initially, 300mg/2 weeks; maintenance: 210mg/2 weeks or 405mg/4 weeks. 20mg/day: Initially, 300mg/2 weeks; maintenance: 300mg/2 weeks. Renal / hepatic impairment: Consider lower starting dose (150mg every 4 weeks) R Over 75, not recommended. Q Not recommended. D known narrow-angle glaucoma risk. Lactation. B Not for use in acutely agitated or severely psychotic states. Post-injection syndrome may occur; monitor patients for 3 hours for signs and symptoms of overdose. Not recommended: Dementia-related psychosis and/or behavioural disturbances. Neuroleptic Malignant Syndrome may rarely occur. Hyperglycaemia and/or development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, (incl. fatal) reported rarely. Regularly monitor patients for lipid alterations. Caution: Prostatic hypertrophy, or paralytic ileus and related conditions; low leukocyte and/or neutrophil counts, medicines known to cause neutropenia, history of drug-induced bone marrow depression/ toxicity, bone marrow depression; history of seizures or risk factors for seizures. VTE may very
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
B Impaired hepatic function, prostatic hypertrophy, paralytic ileus, bone marrow depression, neuroleptic malignant syndrome, seizures, tardive dyskinesia. Parkinsonâ&#x20AC;&#x2122;s/dementiarelated psychosis and/or behavioural disturbances (not recommended). Monitor diabetic patients. Neutropenia when used concomitantly with valproate. Monitor BP in elderly. Undesirable alterations in lipids have been observed (monitor regularly). Sudden cardiac death reported with antipsychotics. Pregnancy. Driving/ using machinery. Contains lactose. Velotab contains aspartame, mannitol, methyl/propyl parahydroxybenzoate. Zyprexa inj: Unstable medical conditions, alcohol/drug intoxication (no data), hypotension, bradyarrhythmia, hypoventilation, level of consciousness (monitor). C Avoid anti-Parkinsonian drugs. Caution: Activated charcoal (take 2 hrs apart), smoking, carbamazepine, dopamine agonists, fluvoxamine, ZYPREXA Lilly drugs inducing CNS depression (incl. alcohol) or hypotension, bradycardia, respiratory nervous 2NO system depression or increase QTc interval. Thienobenzodiazepine. Olanzapine 2.5mg, 5mg, Zyprexa inj: Simultaneous inj. of parenteral 7.5mg, 10mg, 15mg. White film-ctd tabs. marked benzodiazepines. LILLY and 4112, 4115, 4116 or 4117. 15mg A Somnolence, clinically significant weight elliptical, blue film-ctd tab. marked LILLY 4415. gain especially in adolescents, increased appetite, 2.5mg-28, A41.69; 5mg-28, A58.80; 7.5mg-56, dizziness, dyskinesia, asthenia, oedema, orthostatic A176.43; 10mg-28, A117.62; 15mg-28, A185.00. hypotension, anticholinergic effects, eosinophilia, 2NO raised ALT/AST. Worsening of Parkinsonian ALSO ZYPREXA VELOTAB Olanzapine 5mg, 10mg, symptoms. Elderly with dementia: Abnormal gait 15mg, 20mg. Freeze dried orodispersible tabs. and falls, pneumonia, increased body temperature, 5mg-28, A70.57; 10mg-28, A141.15; 15mg- 28, lethargy, erythema, visual hallucinations, urinary A221.23; 20mg-28, A227.52. incontinence. S Schizophrenia. Bipolar Disorder (BD): Treatment of moderate to severe manic episodes; 3.4 MOOD DISORDERS, BULIMIA prevention of recurrence in patients with BD NERVOSA, OCD whose manic episode has responded to olanzapine treatment. ABILIFY BMS P Schizophrenia: Starting dose, 10mg as a single daily dose. Bipolar Disorder: Manic episode, 2 N O initially 15mg as single daily dose in monotherapy Atypical antipsychotic. Aripiprazole 5mg, 10mg, or 10mg daily in combination therapy. Prevention, 15mg, 30mg. Rect. and blue, rect. and pink, round and yellow, round and pink tabs., marked A-007 initially 10mg daily or same dose as prior treatment of manic episode. Continue olanzapine and 5, A-008 and 10, A-009 and 15, A-011 and 30 in combination therapy as required if new manic/ resp. 5mg-28, A123.79; 10mg-28, A128.41; 15mg28, A128.41; 30mg-28, A256.82 mixed/depressive episode occurs. All indications: S Schizophrenia (adults and adolescents Adjust if necessary within range of 5-20mg daily. q 15 years). Treatment of moderate to severe Renal/hepatic impairment: Consider 5mg starting manic episodes in Bipolar I Disorder and dose. Place Velotab in mouth to be dispersed in prevention of new manic episodes in patients who saliva so it can be easily swallowed. R 65 and over, consider starting dose 5mg experienced predominantly manic episodes and whose manic episodes responded to aripiprazole. daily when clinical factors warrant. P 10 or 15mg (10 or 15ml) once daily; Q Not recommended. Maintenance, 15mg daily. Max. 30mg daily. 2NO R Consider lower starting dose. ALSO ZYPREXA 10MG INJECTION Olanzapine Q Under 15 years, not recommended. Over 10mg. Yellow lyophilised powder for soln. for IM 15 years, schizophrenia: Initially 2mg for 2 days A inj. 1, 5.00. S Rapid control of agitation and disturbed titrated to 5mg for 2 additional days to reach behaviours in patients with schizophrenia or manic recommended daily dose (10mg). May be increased in 5mg increments to max 30mg daily. episode, when oral therapy is not appropriate 2NO (short term use). The use of oral olanzapine ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. should be initiated as soon as clinically Orodispersible round tab. marked with strength appropriate. P Starting dose, 10mg as a single IM inj. A on one side and A over 640 or 641 resp. on reverse. 10mg, pink; 15mg, yellow. 10mg-28, second inj. may be admin. 2 hours after first inj. A141.12; 15mg-28, A141.12. based on clinical status. Max. daily dose: 20mg S Schizophrenia. Treatment of moderate with not more than 3 inj. in any 24-hour period. Max. duration: 3 consecutive days. Do not admin. to severe manic episodes in Bipolar I Disorder and prevention of new manic episodes in patients who by IV or SC inj. experienced predominantly manic episodes and R 60 years and over, consider starting whose manic episodes responded to aripiprazole. dose 2.5-5mg with a second injection of 2.5-5mg after 2 hours depending on patient clinical status. 2 N O ALSO ABILIFY ORAL SOLUTION Aripiprazole 1mg/ Q Under 18 years, not recommended. 1ml. Bottle. 150 ml, A137.36 D Narrow angle glaucoma. Lactation. rarely occur, take preventive measures. If tardive dyskinesia occurs consider dose reduction or discontinuation. Postural hypotension risk in elderly; measure BP periodically in patients q 65 years. Pregnancy (use only if benefits outweigh risks). Driving/operating machinery. C Not recommended: Anti-Parkinsonian drugs. Caution: Smoking, carbamazepine, alcohol, CNS depressants, medicinal products known to increase QTc interval, dopamine agonists. Fluvoxamine or other CYP1A2 inhibitors (e.g. ciprofloxacin): Consider lower starting dose. A Eosinophilia, weight gain, elevated cholesterol/triglycerides/glucose levels, glucosuria, increased appetite, somnolence, dizziness, akathisia, parkinsonism, dyskinesia, orthostatic hypotension, GI disorders, transient asymptomatic ALT and AST elevations, rash, asthenia, fatigue, oedema, elevated plasma prolactin levels.
96
S Schizophrenia. Moderate to severe manic episodes in Bipolar I Disorder and prevention of new manic episodes in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole.
2N ALSO ABILIFY SOLUTION FOR INJECTION Aripiprazole 7.5mg/ml. Clear, colourless, aqueous sln for inj. S Rapid control of agitation and disturbed behaviours in patients with schizophrenia or in patients with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate. Treatment with aripiprazole solution for inj. should be discontinued as soon as clinically appropriate and use of oral aripiprazole should be initiated. P For IM use. Initially, 9.75mg (1.3 ml), as a single IM inj. Effective dose range: 5.25-15mg as a single inj. A lower dose of 5.25 mg (0.7 ml) may be given, according to clinical status. A 2nd inj. may be admin 2 hrs after the 1st inj. Max 3 inj. in 24 hr. Max daily dose 30mg (incl. all formulations of aripiprazole). R Consider lower starting dose. Q Under 18 yrs, not recommended. D Pregnancy (unless benefit outweighs risk), lactation. B Monitor for suicidal behaviour particularly after initiation or switching of therapy. Severe hepatic impairment, history of seizure disorder or conditions associated with seizures, diabetes mellitus, CVD, cerebrovascular disease, predisposition for hypotension or hypertension, family history of QT prolongation, risk of aspiration pneumonia. Monitor for signs of hyperglycaemia, tardive dyskinesia, neuroleptic malignant syndrome. Not approved for dementiarelated psychosis. Driving/using machines. Hypersensitivity reactions may occur. C Caution: Potent inhibitors of CYP2D6 (eg. quinidine, fluoxetine, paroxetine) or CYP3A4, potent CYP3A4 inducers, certain antihypertensives, drugs causing QT prolongation, alcohol or other CNS drugs. A Somnolence, dizziness, headache, akathisia, nausea, vomiting, restlessness, insomnia, anxiety, extrapyramidal disorder, akathisia, tremor, dizziness, somnolence, sedation, blurred vision, GI disorders, fatigue.
AFFEX
Astellas
2NO SSRI. Fluoxetine 20mg. Green/yellow cap. marked F.20. 30, A9.01. S Major depressive episodes. Bulimia nervosa. Obsessive-compulsive disorders (OCD). See fluoxetine Drug Prescribing Notes. P Depression: usually 20mg daily. Most patients do not require more than 20mg daily. OCD: initially 20mg daily for several weeks increasing thereafter, up to 60mg. Bulimia nervosa: 60mg daily. Max. daily dose should not exceed 80mg. Q Under 18 years, not recommended.
ANAFRANIL
Novartis
2NO TCA. Clomipramine (HCl) 10mg orange/caramel cap. 25mg brownish orange/caramel cap. 50mg light grey/caramel cap. All marked GEIGY. 10mg84, A3.46; 25mg-84, A6.92; 50mg-56, A8.64. S Depression incl. manic depression, obsessional and phobic states. Adjunctive treatment of cataplexy.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
Zyprexa is indicated for the treatment of schizophrenia. Zyprexa is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Zyprexa is indicated for the treatment of moderate to severe manic episode. In patients whose manic episode has responded to Zyprexa treatment, Zyprexa is indicated for the prevention of recurrence in patients with bipolar disorder. Full Prescribing Information is Available From: Eli Lilly and Company (Ireland) Limited, Hyde House, 65 Adelaide Road, Dublin 2, Republic of Ireland. Telephone: Dublin (01) 661 4377. ZYPREXA (olanzapine) and VELOTAB are trademarks of Eli Lilly and Company. Marketing Authorisation Numbers and Holder: EU/1/96/022/002. EU/1/96/022/004. EU/1/96/022/006. EU/1/96/022/009. EU/1/96/022/010. EU/1/96/022/012. EU/1/96/022/016. EU/1/99/125/001. EU/1/99/125/002. EU/1/99/125/004. EU/1/99/125/003. Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, The Netherlands. P.O.M IEZYP00119
Date of preparation: August 2009
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
P Depression: 10mg increasing gradually to 30-150mg daily individed doses or as a single dose at night; max. 250mg daily. Obsessional and phobic states: 25mg daily increasing gradually to 100-150mg daily. Cataplexy: 10mg daily increasing up to 50mg daily. R Initially 10mg daily. Max. 75mg daily Q Not recommended
2NO ALSO ANAFRANIL SR Clomipramine (HCl) 75mg. Pink cap.-shaped sust.-release tab. Scored both sides marked CG one side and GD on reverse. 28, A8.04. S Depression; obsessional and phobic states. Adjunctive treatment of cataplexy. P Depression: 10mg increasing gradually to 30-150mg daily in divided doses or as a single dose at night; max. 250mg daily. Obsessional and phobic states: 25mg daily increasing gradually to 100-150mg daily. Cataplexy: 10mg daily increasing up to 50mg daily. R Initially 10mg daily. Max. 75mg daily. Q Not recommended. D Pregnancy, lactation. Hypersensitivity to dibenzazepines,cardiac arrhythmias, mania, severe liver disease, narrow angle glaucoma, urine retention. B Risk of suicide; monitor carefully. Other psychiatric effects, cardiac and vascular disorders, epilepsy, pregnancy, hepatic disease and tumours of the adrenal medulla. Elderly, driving/using machinery. Contains lactose. C Contra: MAOIs (or within 3 weeks), adrenergic neurone blockers, anticholinergic drugs, CNS depressants, diuretics, MAOIs, SSRIs, CYP2D6 inhibitors, neuroleptics, H2 receptor antagonists, methylphenidate, CYP450 enzyme inducers. A Drowsiness, fatigue, restlessness, increased appetite, confusion, disorientation, hallucinations, sleep disturbances, aggressiveness, aggravated depression, dizziness, tremor, headache, myoclonus, delerium, speech disorders, muscle weakness, dry mouth, blurred vision, disturbances in micturition, hot flushes, mydriasis, tachycardia, postural hypotension, ECG changes, GI disorders, elevated transaminases, skin rash, urticaria, pruritus, weight gain, disturbances of libido and potency, galactorrhea, breast enlargement, taste disturbances, tinnitus.
OCD
CNS
Q Not recommended. B Should not be used under 18 years. Severe renal failure: Not recommended. Impaired hepatic function: Reduce dose, monitor liver function. May occur: Initial anxiogenic effect when starting therapy (reduced dose reduces risk), serotonin syndrome (discontinue), hyponatraemia, syndrome of inappropriate anti-diuretic hormone secretion (elderly), may increase psychotic symptoms. Withdraw gradually. Pregnancy, lactation. Contains lactose. C Contra: MAOI (or within 14 days), 5-HTagonists. Caution: Lithium, metoprolol, desipramine, dimetidine, St John’s Wort. A Headache, tremor, dizziness, migraine, paraesthesia, palpitations, tachycardia, postural hypotension, hypotension and hypertension, GI disorders, micturition disorder, polyuria, weight decrease/increase, rhinitis, sinusitis, ejaculation failure, female anorgasmia, dysmenorrhoea, impotence, increased sweating, rash, pruritus, abnormal accommodation, abnormalities of vision, taste abnormalities.
BELLSERT
Ranbaxy
2MO SSRI. Fluoxetine 20mg (as HCl) Green/off white hard gelatine self locked size 2 cap. containing white powder, imprinted with R/FXT 20 on cap/ body. 20mg-30, A14.48. S Major depressive disorders/episodes. Bulimia nervosa in conjunction with psychotherapy. P Major depressive episodes: 20mg/day. Bulimia nervosa: 60mg/day. Max daily dose 80mg. Reduced liver and/or kidney function (GFR 1050ml/min): Reduce dose (e.g. 20mg every other day). R Caution when increasing dose.Rarely exceed 40mg. Max 60mg. Q Not recommended. D Severe renal failure (GFRQ10ml/min), unstable epilepsy or convulsant disorders. Lactation. See fluoxetine Drug Prescribing Notes.
BIOZAC
Niche
2NO
Ranbaxy SSRI. Fluoxetine (HCl) 20mg. Olive/green cap.
2MO
SSRI. Sertraline 50mg, 100mg. White film-ctd caplet-shaped tab. embossed with strength one side and break-line the other. 50mg-28, A20.57; 100mg-28, A30.69. S Major depressive episodes. P 50mg once daily with sufficient liquid. If required, may be increased to 100mg/day. Increments in steps of 50mg at minimum intervals of 1 week. Aim for lowest possible dosage with adequate therapeutic efficacy during long term therapy. Impaired hepatic function: Reduce dose, prolong interval between doses. Antidepressant effect may start within 7 days, max effect after 2 to 4 weeks (inform patient). May require long term therapy to control remission (at least 6 months). R Lowest possible dosage. Q Under 18 years, not recommended. B Monitor suicidality. Caution: History of mania/hypomania, epilepsy (unstable epilepsy, avoid use; controlled stable epilepsy, careful monitoring; discontinue if seizures occur), ECT, diabetes (check blood glucose levels regularly; adjust insulin and/or hypoglycaemics) history of BELLCITAL Ranbaxy bleeding disorders, instable cardiac disease, elderly, schizophrenia (may aggravate symptoms), 2MO impaired hepatic function. Withdraw gradually. SSRI. Citalopram (hydrobromide) 10mg, 20mg. Pregancy and lactation (use only if benefit White to off-white circular biconvex film-ctd tab. debossed with strength on one side and the other outweighs risk). Driving/operating machinery. C Contra: MAOIs (or within 14 days), side plain or with a lip shaped scoreline, resp. pimozide. Not recommended: Serotonergics 10mg-28, A9.41; 20mg-28, A13.92. (tryptophan, fenfluramine and serotonin agonists), S Major depressive episodes. Panic St John’s Wort. Caution: Drugs bound to plasma disorder with or without agoraphobia. P Major depressive episodes: Single 20mg proteins, diazepam, tolbutamide, cimetidine, hypoglycaemics, anticoagulants, salicylic acid daily oral dose. Can be increased gradually by derivatives and NSAIDs, lithium, diuretics, 10mg. May be increased to max 40-60mg daily. phenytoin, sumatriptan, antipyrine, changeover Antidepressant effect not expected for at least 2 from other SSRIs or other antidepressants. Avoid weeks. Treatment duration at least 4-6 months. Panic disorder: Single dose 10mg/day for 1st week. alcohol. Dose may be increased to max 40-60mg/day. Max A GI disorders, dry mouth, increased sweating, tremor, dizziness, insomnia, somnolence, effect after 3 months. May need to be continued anorexia, sexual disorders, asthenia, tiredness, hot for several months. Reduced hepatic function: flushes, skin rash, chest pain, palpitations, tinnitus, Initially 10mg/day. Max 30mg. headache, motor disorders (incl. hyperkinesia, R Major depressive episodes: 10-20mg increased musle tone, teeth grinding, impaired daily. May be increased to max 30-40mg daily. gait), paraesthesiae, hypaesthesia, yawning, Panic disorder: Initially 10mg once daily, after 1 agitation, anxiety, menstrual disorders, impaired week may be increased to 20mg daily. May be increased to max 40mg daily. vision.
98
BELLZAC
marked FLE 20. 30, A13.34. S Episodes of depression, with or without associated anxiety symptoms, especially where sedation is not required. P 20mg daily recommended. Max. 80mg daily. R Caution. Max. 60mg daily. Q Under 18 years, not recommended. D Severe renal failure, unstable epilepsy. See fluoxetine Drug Prescribing Notes.
CALMAX
Ergha
2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. marked ’apzm 1’ resp. All tabs. oblong, scored. 0.25mg-100, A2.03. 0.5mg-100, A3.92. 1mg-100, A8.18. S Anxiety disorders. P 0.25-0.5mg three times daily. Max. 4mg daily. R 0.25mg two or three times daily. Q Not recommended. D See SPC.
CAMCOLIT
Norgine
2NO Lithium salt. Lithium carbonate 250mg (equiv. to 6.8mmol Li+ ) tab. marked CAMCOLIT; 400mg (equiv. to 10.8mmol Li+ ) cont.-release tab. marked CAMCOLIT-S. Both white film-ctd tabs. with a breakline. 250mg-100, A3.41 250mg-1000, A30.66; 400mg-100, A4.59; 400mg-500, A18.73. S Treatment and prophylaxis of mania; bipolar affective disorders, recurrent depression. Treatment of aggressive or self-mutilating behaviour. P Treatment, maintain serum lithium levels in range 0.6-1.0mmol/l 12 hours after last dose. Prophylaxis, maintain serum lithium levels 0.4-0.8mmol/l. R Maintain serum lithium levels 0.40.7mmol/l. Toxic symptoms more likely q 1.0mmol/l. Q Not recommended. D Renal disease, hypothyroidism, cardiac disease, Addison’s disease. Discontinue 24 hours before major surgery. Pregnancy, lactation.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
MOOD
DISORDERS, BULIMIA NERVOSA,
to lower end of dose range. R 20mg daily. May be increased to max 40mg daily. Q Under 18 years, not recommended. B Discontinue if patient enters manic phase. Initial anxiogenic effect may occur when starting therapy (reduce dose). Prolonged bleeding time and/or bleeding abnormalities may occur. Caution: Diabetes, controlled epilepsy (discontinue if seizures develop). Unstable epilepsy (avoid). Monitor for clinical worsening and suicidal behaviour. Pregnancy, lacation. C Contra: MAOI (within 14 days), 5-HTagonists. Caution: Lithium, tryptophan, anticoagulants, NSAIDs, ASA, dipyridamol, ticlopidine, atypical antipsychotics, phenothiazines, TCAs. Avoid alcohol. CIPRAGER Gerard A Increased sweating, headache, tremor, dizziness, abnormal accommodation / vision, 2NO somnolence, insomnia, agitation, nervousness, GI SSRI. Citalopram (hydrobromide) 10mg, 20mg, 40mg. White film-ctd tab. debossed CM 10, CM 20 disorders, palpitation, asthenia, rash, pruritus, paraesthesia, migraine, taste perversion, sleep and CM 40 on one side and G on reverse. 10mg, disorder, decreased libido, impaired concentration, round; 20 and 40mg, oval with breakline. 10mgabnormal dreaming, amnesia, anxiety, increased A A A 28, 9.60; 20mg-28, 15.05; 40mg-28, 31.07. appetite, anorexia, apathy, impotence, suicide S Major depressive episodes, panic attempt, confusion, yawning, weight decrease / disorder with or without agoraphobia. increase, postural hypotension, tachycardia, P Single oral dose (morning or evening) taken with fluid. Major depressive episodes: 20mg rhinitis, micturition disorder, polyuria, ejaculation daily; max: 60mg daily. Continue 4-6 months after failure, female anorgasmia, fatigue. symptom remission. Panic disorder: 10mg daily for CIPRAMIL Lundbeck week 1, then increase to 20mg and up to 60mg 2NO daily as required. SSRI. Citalopram (hydrobromide) 10mg, 20mg. R Major depressive episodes: 10mg daily; max: 30mg daily. Panic disorder: 10mg daily; max: White film-ctd tabs. 10mg, round marked CL. 20mg, oval, scored, marked C and N. 10mg-28 40mg daily. (Cal/Pk), A5.77; 20mg-28 (Cal/Pk), A9.04. Q Under 18 years, not recommended. S Depressive illness in the initial phase D Severe renal impairment (no data). and maintenance therapy against relapse or Pregnancy, lactation. recurrence. Panic disorder with or without B Epilepsy (discontinue if seizures), ECT, agoraphobia. history of mania, psychotic patients. Diabetes, P Depression, 20mg once daily (effect bleeding disorder, hepatic impairment (decrease after 2-4 weeks); panic disorder, 10mg once daily dose). Panic disorder experience (low starting for 1st week then 20mg daily (max. effect after 3 dose). months). May be increased to max. 60mg daily. C MAOI, 5-HT drugs, St John’s wort, Reduced hepatic function: Max. 30mg daily. alcohol. Caution: Substances increasing R Max. 40mg daily. haemorrhage risk (anticoagulants, atypical Q Under 18 years, not recommended. antipsychotics, phenothiazines, tricyclic 2NO antidepressants, aspirin, NSAID), Lithium, cimetidine. ALSO CIPRAMIL DROPS Citalopram (HCl) 40mg/ml A Somnolence, insomnia, anxiety, suicide. (equiv. 20mg per 10 drops). 15ml, A29.72. Dizziness, tremor, headache, paraesthesia, P Depression, 16mg (8 drops) once daily palpitations, tension disorders. Nausea, dry mouth, mixed with water, orange or apple juice; panic GI disorders, sweating, rash, pruritus, abnormal disorder, 8mg for 1st week, increasing to 16mg accommodation, asthenia, polyuria, rhinitis, daily. Increase if necessary to max. 48mg daily. sinusitis, anorgasmia, impotence, dysmenorrhoea. Reduced hepatic function: Max. 24mg daily. R Max. 32mg daily. CIPRALAM Actavis Q Under 18 years, not recommended. B Caution: Seizures, mania (discontinue), 2NO diabetes, history of bleeding abnormalities, SSRI. Citalopram (as hydrobromide) 10mg, 20mg. pregnancy, lactation. Reported: Hyponatraemia, White, circular, biconvex film-ctd tabs. 20mg suicidal thoughts, akathisia, serotonin syndrome. scored on both sides; can be divided into equal Withdraw gradually. Driving/using machines. A A halves. 10mg-28, 9.04; 20mg-28, 14.16. S Depressive illness treatment in the initial C Contra: Pimozide, MAOIs (non-selective, selective A). Caution: Selegiline, 5HTagonists, st phase and as maintenance against potential relapse/recurrence. Panic disorder with or without John’s Wort, lithium, tryptophan, drugs affecting platelet function, ECT, alcohol. agoraphobia. P Depression: Single 20mg daily oral dose. A Nausea, sweating, diarrhoea, If necessary, may be increased to max 60mg daily. somnolence, insomnia, dry mouth. Decreased appetite, tremor, paraesthesia, agitation, anxiety, Treatment duration of at least 6 months usually confusional state, libido decreased, abnormal necessary. Panic disorder: Single dose of 10mg st daily the 1 week. May be increased to 20mg and orgasm, impotence, yawning, tinnitus, pruritus, up to 60mg daily max. Max effect reached after 3 myalgia, arthralgia, fatigue, weight decrease. months. May need to be continued for several Pinewood months. Reduced hepatic function: Restrict dosage CIPRAPINE
Disturbed Na+ balance. B Monitor patients for renal/thyroid/ cardiac function, urine analysis. Patients should be euthyroid before starting therapy. If polyuria, polydipsia, nausea or vomiting occurs, patient should report. Signs of lithium toxicity (discontinue and review). Caution: Elderly patients, patients with CVD or QT prolongation. C Avoid: Other antipsychotics. Diuretics, NSAIDs, phenytoin, carbamazepine, caffeine, QT prolonging drugs, Na+ salts, bulk laxatives (ispaghula). SSRIs, TCADs, caffeine. A Nausea, diarrhoea. Tremor of hands, muscle weakness, psoriasis, hypo/hyperthyroidism, weight gain, oedema, ECG disturbances, polyuria, polydipsia.
OCD
3.4
2NO SSRI. Citalopram (hydrobromide) 10mg, 20mg. Both white, round, film-coated tabs. 10mg-28, A9.57; 20mg-28, A15.00. S Major depressive episodes. P To be taken with fluid. Initially, 20mg/ day as single dose. Increase to 40mg/day, depending on patient response. Max. 60mg/day. Withdraw slowly over 1-2 week. Hepatic Impairment: Initially 10mg/day, max 30mg/day, monitor patient. R Adjust half of recommended dose. Q Under 18 years, not recommended. B Risk of suicide in initial treatment phase (all SSRIs). Risk of overdose. Mania/hypomania, psychosis, epilepsy, seizures, bleeding abnormalities, severe renal impairment. Diabetics, insulin and/or oral hypoglycaemic, dosage may require adjustment. Serotonin Syndrome, hyponatraemia and SIADH, impaired hepatic function, insomnia/agitation, ECG monitoring in cases of overdose or conditions of altered metabolism. Driving and operating machinery. Pregnancy, lactation. C Contraindicated: MAOIs, incl. selegiline (selective MAOI) and moclobemide (reversible MAOI or RIMA). Patients recently discontinued SSRI and commenced a MAOI. Caution: 5-HT receptor agonists (triptans, incl. sumatriptan), tramadol, oxitriptan, tryptophan, St John’s Wort, cimetidine, lithium, tryptophan, desipramine. Anticoagulants/drugs affecting thrombocyte function (NSAIDs, acetylsalicylic acid, dipyridamol, ticlopidine), drugs increasing haemorrhage risk (atypical antipsychotics, phenothiazines, TCAs). Alcohol (not advised). A Sleep disorders, anxiety/nervousness, headache, tremor, dizziness, weight fluctuation, palpitations, GI upset, sweating, visual disturbances, asthenia/fatigue, somnolence, insomnia, agitation, withdrawal reactions.
CIPROTAN
Clonmel
2NO SSRI. Citalopram (hydrobromide) 10mg, 20mg. Round, white film-ctd tabs. 20mg with breakline. 10mg-28, A8.65; 20mg-28, A12.84. S Major depressive episodes. P Initially, 20mg per day. If necessary, the dose can be increased up to 40mg per day. Max., 60mg per day. Admin. as single dose in the morning or in the evening with fluid. Reduced hepatic function: Initially 10mg; max. 30mg daily. R Half of recommended dose. Q Under 18 years, not recommended. B Caution with: Diabetes, epilepsy, electro-convulsive therapy, history of mania/ hypomania, psychotic patients, bleeding disorders. Suicidality. Severe renal impairment; not recommended. Hepatic impairment; monitor liver function. Pregnancy, lactation (only if clearly necessary). C MAOIs (wait 2 weeks after stopping), St John’s wort, 5-HT agonists. Caution: anticoagulants, NSAIDs and other drugs increasing risk of haemorrhage, metoprolol, cimetidine, lithium, desipramine. A Headache, tremor, dizziness, sleep disorders, agitation, confusion, weight change, vision or taste abnormalities, asthenia, palpitations, sweating, rash, sexual disorders, GI disorders, rhinitis, sinusitis.
CITALOPRAM TEVA
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
Teva
99
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
rhinitis, sinusitis, sexual disorders, rash, vision or taste abnormalities.
Pregnancy, lactation (only if essential). Monitor renal function (elderly), suicide risk. Monitor weight/growth in children receiving long-term CYMBALTA Lilly treatment. Withdraw gradually. C Contra: MAOIs, pimozide, alcohol. 2NO 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, Caution: Serotonergics, lithium, St John’s wort, TCAs, anticoagulants, NSAIDs, tolbutamide, 60mg. Opaque caps. White body marked 30mg insuline, diazepam, cimetidine, CYP2D6 substrates, with blue cap marked 9543; green body marked phenytoin. 60mg with blue cap marked 9542 resp. 30mg-28, A GI disorders, dyspepsia, dry mouth, A 20.50; 60mg-28, A 34.15. sweating, tremor, dizziness, insomnia, somnolence, S Major depressive disorder. anorexia, headache, motor disorders, anxiety, male P Recommended dose, 60mg once daily. sexual disorders, menstrual disorders, tiredness, Response usually seen after 2-4 weeks. Max. hot flushes, rash, chest pain, palpitations, tinnitus, 120mg daily given in evenly divided doses. After consolidation of response, continue treatment for impaired vision. Hyperkinesias, tremor, urinary incontinence and fever in children. several months. In responding patients with history of repeated major depressive episodes, DOTHEP Gerard consider further long-term treatment with 60120mg/day. Discontinue gradually over 1-2 weeks. 2 N O Q Under 18 years, not recommended. TCA. Dothiepin (HCl) 25mg. Red/brown cap. D Liver disease resulting in hepatic marked G DN 25. 100, A4.51. impairment, severe renal impairment (ccQ30ml/ S Depression, anxiety associated with min), uncontrolled hypertension. Pregnancy (unless depression. essential), lactation. 2NO B History of mania, bipolar disorder, ALSO DOTHEP TABLETS Dothiepin (HCl) 75mg. seizures, increased IOP or risk of acute narrowRed film-ctd tab. marked DN/75 one side and G on angle glaucoma. Hypertensive crisis reported. reverse. 28, A3.54; 100, A12.32. Hypertension, cardiac disease; monitor BP at least P 75-150mg daily in divided doses or as 1st month. Elderly. Suicidal thoughts; monitor single dose in the evening. carefully. May occur: Liver injury, incl. severe R Initially 50-75mg daily. elevations of liver enzymes, hepatitis and jaundice. Q Not recommended. Akathisia may develop. Driving/using machines. D See SPC. Contains sucrose. EDRONAX Pfizer C Non-selective, irreversible MAOIs and potent CYP1A2 inhibitors, eg. fluvoxamine, 2NO ciprofloxacin, or enoxacine (all contraindicated), Selective NA reuptake inhibitor. Reboxetine 4mg. other MAOIs (not recommended). Caution: White round, convex, scored tab. marked P/U and Anticoagulants, St John’s wort, warfarin, CYP2D6 7671 60, A25.36. substrates, other centrally acting and sedative S For the acute treatment of depressive drugs, smoking. illness/major depression and for maintaining A Weight decrease, palpitations, tremor, clinical improvement. paraesthesia, blurred vision, tinnitus, yawning, GI P 4mg twice daily. Increase if necessary disorders, increased sweating, rash, musculoafter 3-4 weeks to 10mg daily. Max. 12mg daily. CITROL Rowex skeletal pain, muscle tightness, muscle spasm, Renal or hepatic impairment, initially 2mg twice 2NO decreased appetite, flushing, fatigue, abdominal daily. SSRI. Citalopram (hydrobromide) 10mg, 20mg, pain, erectile dysfunction, insomnia, agitation, R Not recommended. 30mg. 10mg, round tab; 20mg and 30mg, oblong decreased libido, anxiety, abnormal orgasm, Q Under 18 years, not recommended. biconvex tabs. with one sided score notch marked abnormal dreams. D Pregnancy, lactation. C20 and C30. All white film-ctd. 10mg-28, A9.61; B History of convulsive disorders or heart 10mg-30, A11.08; 20mg-28, A15.05; 30mg-28, DEPREGER Gerard disease, urinary retention, prostatic hypertrophy, A28.00 glaucoma, bipolar patients. Monitor for suicidality. 2NO S Major depressive episodes. SSRI. Sertraline (as HCl) 50mg, 100mg. White, film- C Not recommended: CYP3A4 inhibitors P Usual dose, 20mg daily increasing to e.g. azole antifungal agents; macrolide antibiotics ctd tab. with ST breakline 50 or 100 on one side max. 60mg daily. Effect after at least 2 weeks; e.g. erythromycin or fluvoxamine. Avoid: MAOIs. and G on reverse. 50mg-28, A18.28; 100mg-28, continue until no symptom for 4-6 months. Caution: Ergot derivatives. Other antidepressants, A31.57. R 10mg daily. Max. 30mg daily. K+ losing diuretics; no data. S Depression (treatment and prevention Q Under 18 years, not recommended. A Insomnia, vertigo, tachycardia, of relapses). Treatment of obsessive-compulsive B Risk of suicide until therapeutic effects palpitation, vasodilation, postural hypotension, disorder (OCD), panic attacks with/without are achieved. Diabetes, unstable epilepsy, history agoraphobia, post-traumatic stress disorder (PTSD). eye disorders (abnormality of accommodation), dry of mania, bleeding disorders, hepatic or severe mouth, constipation, loss of appetite, sweating P Depression, OCD: 50mg daily; max. renal impairment. Driving/operating machines. UTIs and other urinary disorders, male sexual 200mg daily. Panic attacks , PTSD: Initially 25mg ECT. Lactation, pregnancy (only if essential). disorders, chills. daily; increase to 50mg daily after 1 week; max. Withdraw slowly. C MAOIs (within 14 days); contraindicated. 200mg daily. Increase in 50mg steps at min. 1 EFAXIL XL Pinewood Alcohol, St John’s Wort, 5-HT agonists, tryptophan; week intervals. Max. effect reached after 2-4 2MO weeks. not recommended. Caution: CYP2D6 substrates, Q Under 6 years, not recommended. OCD: 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) cimetidine, lithium, desipramine, neuroleptics, anticoagulants and drugs increasing bleeding risk 13-17 years, initially 50mg daily. 6-12 years initially 75mg, 150mg. Resp., flesh opaque/flesh opaque or scarlet opaque/scarlet opaque, size 0 or size 00 25mg daily; increase to 50mg daily after 1 week. (e.g. NSAIDs, antipsychotics, TCAs). Max. 200mg daily. Major depressive episode, panic hard gelatine cap. containing 2 or 3 white round, A Somnolence, insomnia, agitation, disorder, PTSD: Under 18 years, not recommended. biconvex film-ctd tabs. 75mg-28, A22.15; 150mgnervousness, headache, tremor, dizziness, 28, A37.35. D Severe hepatic impairment, unstable palpitations, nausea, dry mouth, GI disorders, S Treatment of depressive illness, incl. epilepsy. increased sweating, abnormal accommodation, depression accompanied by anxiety. Following B Impaired hepatic function, controlled asthenia, tachycardia, hypotension, hypertension, micturition disorder, polyuria, weight change, initial response, for the prevention of relapses of epilepsy, heart disease, risk of haemorrhage.
2NO
SSRI. Citalopram hydrobromide eq. to citalopram 40mg. White oval film-ctd tab. with break-line. 40mg-28, A27.10. S Major depressive episodes. P Single 20mg daily oral dose. If necessary, can be increased up to 40mg daily; max. 60mg daily. Effect not to be expected for at least 2 weeks. Continue until 4-6 months free of symptoms. Mild/moderate hepatic impairment: Initially, 10mg daily for first 2 weeks; may be increased to 30mg daily. R 10-20mg (max. 40mg) daily. Q Under 18 years, not recommended. B Severe renal impairment (avoid). May occur: Akathisia, serotonin syndrome (discontinue), hyponatraemia, bleeding abnormalities, psychotic symptoms. Caution: Diabetes, controlled epilepsy (discontinue if seizures develop), unstable epilepsy (avoid), history of mania/hypomania, ECT. Monitor for clinical worsening and suicidal behaviour. Withdraw gradually over 1-2 weeks. Pregnancy (if clearly necessary), lactation. Contains lactose. C Contra: MAOI (or within 14 days following their discontinuation). Avoid: Serotonergics (e.g. tryptophan, triptans, 5HTP, tramadol), St John’s Wort, alcohol. Caution: QT interval prolonging drugs, drugs lowering seizure threshold (e.g. antidepressants, neuroleptics, mefloquin, bupropion), drugs increasing risk of haemorrhage (e.g. anticoagulants, NSAIDs, acetylsalicylic acid, dipyridamol, ticlopidine, atypical antipsychotics, phenothiazines, TCAs). A Somnolence, insomnia, agitation, headache, tremor, dizziness, paraesthesia, impaired concentration, abnormal dreaming, amnesia, anxiety, increased appetite, anorexia, apathy, confusion, palpitations, tachycardia, BP change, GI disorders, micturition disorder, polyuria, weight change, rhinitis, sinusitis, dysmenorrhoea, sexual disorders, sweating, rash, pruritus, vision/taste disorders, asthenia.
100
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
behaviour. Caution: Systemic lupus erythematosus. Pregnancy (careful evaluation benefit/risk). Warn patients about risk of weight gain. May cause false positives in urine tests for diabetes. Hyperammonaemia: Metabolic tests advised before therapy in those at risk. Withdraw carefully. C Avoid salicylates in children Q 3 years. Caution: Antipsychotics, MAOIs, antidepressants, benzodiazepines, phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine, zidovudine, vit K-dependent anticoagulants, felbamate, mefloquine, chloroquine, highly protein Avoid salicylates in children Q 3 years. Caution: Antipsychotics, MAOIs, antidepressants, benzodiazepines, phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine, zidovudine, vit K-dependent anticoagulants, felbamate, mefloquine, chloroquine, highly EFEXOR XL Wyeth protein bound agents (eg. aspirin), cimetidine, erythromycin, carbapenem antibiotics, 2NO colestyramine, rifampicin, newer anti-epileptics 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) (e.g. topiramate). 37.5mg, 75mg, 150mg. Resp., opaque peach with A Congenital disorders, transient GI opaque light crey caps, opaque peach, opaque disorders, increased alertness, aggression, dark orange, marked W and strength. All hyperactivity, behavioural deterioration, confusion, prolonged-release hard caps. 37.5mg-7, A3.98; thrombocytopenia, transient hair loss, 75mg-28, A22.83; 150mg-28, A38.50. S Treatment and prevention of recurrence amenorrhoea, dysmenorrhoea, allergic reactions, increased weight. of major depressive episodes. P Initially 75mg once daily. May be Solvay increased to max. 375mg/day. May be increased at FAVERIN 2NO 2 weeks interval to max 375mg/day. If clinically warranted, reduce interval (minimum 4 days). SSRI. Fluvoxamine maleate 50mg round white Severe renal impairment: 1/2 dose. Mild-moderate film-ctd scored tab. marked S and 291. 100mg hepatic impairment: 1/2 dose; further reduction white oval film-ctd scored tab. marked S and 313. may be required in some patients. 50mg-60, A28.99; 100mg-30, A28.99. R Use lowest effective dose. S Treatment of symptoms of depressive Q Under 18 years, not recommended. illness. Obsessive compulsive disorder. B For prescribing information, see P Depression: Initially 50-100mg in the venlafaxine Drug Presc. Notes. evening. Usual maintenance 100mg daily. Max 300mg. OCD: Initially 50mg/day for 3-4 days. Usual EPILIM sanofi-aventis maintenance 100-300mg. Max. 300mg. Dosesq150mg should be given in divided doses. 2MO Q Depression: Not recommended. OCD: EPILIM CHRONO. Carboxylic acid deriv. Sodium Initially 25mg/day. Increase in 25mg intervals every valproate (as valproate and valproic acid) 200mg, 300mg, 500mg. Violet oblong, film-ctd prolonged 4-7 days till effective dose reached. Max. 200mg. Dosesq50mg should be given in divided doses release tab. 200mg-100, A8.25; 300mg-100, with larger dose given at bedtime. A12.38; 500mg-100, A20.64. D Within 2 weeks of stopping MAOIs. 2MO B Bleeding disorders, diabetes, mania/ ALSO EPILIM CHRONOSPHERE Sodium valproate hypomania, monitor for suicidal ideation. Hepatic (as valproate and valproic acid) 100mg, 250mg, 500mg, 750mg, 1000mg. Prolong. release granules or renal insufficiency. History of epilepsy. Pregnancy, lactation. in sachets. 100mg-30, A9.79; 250mg-30, A10.02; 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, C Contra: MAOIs. Caution: TCAs, neuroleptics, tacrine, theophylline, methadone, A18.72. mexiletine, warfarin, thioridazine, propranolol, S Treatment and prevention of mania caffeine, ropinirole, phenytoin, terfenadine, associated with bipolar disorders. astemizole, cisapride, carbamazepine, ciclosporin, P Initially 20mg/kg/day. Usual benzodiazepines, triptans, St. Johnâ&#x20AC;&#x2122;s Wort, lithium, maintenance: 1-2g/day. Max 3g daily. Q Chronosphere, see adults. Epilim Chrono alcohol. A Nausea, vomiting, asthenia, headache, not suitable for children under 20kg. malaise, palpitations, abdominal pain, anorexia, D Active liver disease, personal or family constipation, diarrhoea, dry mouth, dyspepsia, history of severe hepatic dysfunction (esp. drug agitation, anxiety, dizziness, insomnia, related), porphyria. nervousness, somnolence, tremor, sweating. B Risk of severe liver damage (incl.
the initial episode of depression or for the prevention of the recurrence of new episodes. P Swallow whole with food. 75mg once daily for initiation and maintenance. If further clinical improvement required after 2 weeks, may be increased to 150mg once daily. If needed, can be further increased up to 225mg once daily. Increase doses at intervals of 2 weeks or more but no less than 4 days. Discontinue if no evidence of clinical response after 8 weeks. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. Moderate renal impairment: Reduce dose by 50%. R Caution, use lowest effective dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.
daily. Max. of 3mg daily (doses above 2mg daily should be divided). R Half the recommended dosages. If no effect has been observed within 1 week of max. dosage the drug should be withdrawn. Q Not recommended. D Depressed level of consciousness ,coma, excitable or agitated patients; senile confusional states; severe depression. B Severe atherosclerosis, myocardial insufficiency or severe hepatic/renal insufficiency, Parkinsonism or extrapyramidal disease, patients with risk factors for stroke, CVD or family history of QT prolongation. Neuroleptic malignant syndrome has been reported. Tardive dyskinesia may develop. Withdraw gradually. Driving or operating machinery. Contains lactose and sucrose. C Other CNS depressants, QT prolonging drugs, drugs causing electrolyte imbalance. A Restlessness, visual disturbances, migraine, myalgia, general malaise, hyperprolactinaemia, amenorrhoea, somnolence, dizziness, headache, tremor, GI disorders, insomnia.
FLUZAC
Rowex
2NO SSRI. Fluoxetine (HCl) 20mg. Opaque, light green hard gel cap. 30, A14.18. S Major Depressive episodes, obsessive compulsive disorders (OCD), bulimia nervosa. See fluoxetine Drug Prescribing Notes. P Admin. as single or divided dose. Depression: Initially, 20mg daily; may be increased after 3 weeks if no response. Range 20-60mg/day. OCD: Initially 20mg daily; may be increased after 2 weeks if no response. Range 20-60mg/day. Reconsider after 10 weeks if no response. Bulimia nervosa: 60mg daily. Hepatic impairment: Consider lower or less frequent dose e.g. 20mg every second day.
GAMANIL
Merck Serono
2NO
TCA. Lofepramine (HCl) 70mg. Maroon film-ctd scored tab. 56, A11.64; 250, A51.97. S Symptoms of depressive illness. P 2 or 3 daily in divided doses. R May respond to lower doses in some cases. Q Under 18 years: Contraindicated. D Mania, severe hepatic/renal impairment, heart block, cardiac arrhythmias, recovery phase following MI, narrow angle glaucoma, prostatic hypertrophy with urinary retention. Pregnancy, lactation. B CVD, impaired liver/renal function, narrow angle glaucoma, history of epilepsy, prostatic hypertrophy, hyperthyroidism, blood dyscrasias, porphyria, paralytic ileus. Monitor cerebral/haemopoietic function, cardiac conduction disorders. In adolescents, risk of suicidality with antidepressants and no beneficial effects of TCAs demonstrated. Elderly. Driving/using machines. hepatic failure); increased risk in children Q 3 C MAOIs (or within 2 weeks). FLUANXOL Lundbeck years. Liver function tests advised before therapy Sympathomimetics, adrenergic neuron blockers, 2MO and in first 6 months, especially when risk or CNS depressants, anticholinergics, quinidine, history of liver disease. Pancreatitis may occur, esp. Thioxanthene. Flupenthixol (diHCl) 0.5mg, 1mg. digitalis glycosides, cimetidine, clonidine, thyroid Round, biconvex, yellow, sugar-ctd tab. 0.5mg-60, hormone therapy. in young children (prompt medical evaluation in A A 4.09; 1mg-60, 8.31. patients with acute abdominal pain). A Hypotension, tachycardia, cardiac Monotherapy recommended in children Q 3 years S Short-term management of mild to arrhythmias, dizziness, sleep disturbances, at risk of liver toxicity and pancreatitis. Blood cell moderate depression with or without anxiety. agitation, confusion, headache, dry mouth, count, bleeding time and coagulation tests advised P 1mg daily as a single dose in the constipation, sweating, accommodation morning. May be increased after 1 week to 2mg before therapy. Monitor for suicidal thoughts/ disturbances, urinary hesitancy, urinary retention,
102
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
MOOD
DISORDERS, BULIMIA NERVOSA,
elderly, glaucoma (regulary check IOP), high doses. May trigger or exacerbate absences. Increase in seizure frequency or the onset of new types of GEODON Pfizer seizures may occur. Test blood regularly; discontinue if severe leucopenia or 2NO thrombocytopenia appear. Perform liver function 5-HT2A and dopamine (D2) receptor antagonist. tests periodically. Discontinue if severe Ziprasidone (as HCl monohydrate) 20mg blue/ white cap. 40mg blue cap. 60mg white cap. 80mg dermatological reactions, severe hypersensitivity occur. Avoid sunlight exposure. Driving/operating blue/white cap. All marked with Pfizer and ZDX 20, ZDX 40, ZDX 60 or ZDX 80. 20mg-56, A104.01; machines. C Not recommended: MAOIs. Caution: 40mg-56, A109.48; 60mg-56, A120.43; 80mg-56, Anticonvulsants, CYP450 inducers/inhibitors, A158.75. digoxin, theophylline, cisplatin, doxorubicin, S Treatment of manic or mixed episodes clonazepam, St. John’s Wort, azole antimycotics, of moderate severity in bipolar disorder macrolide antibiotics, isoniazid, Ca++ antagonists, (prevention not established). P Acute treatment, 40mg twice daily with acetazolamide, dextropropoxyphene, propoxyphene, viloxazine, danazol, nicotinamide food. Max. 80mg twice daily may be reached at (at high dose in adults), nefazodone, fluvoxamine, day 3. Hepatic insufficiency: Consider lower dose. terfenadine, loratadine, grapefruit juice, protease Q Not recommended. inhibitors, cimetidine (doses r 800mg), D Known QT-interval prolongation, desipramine, phenobarbital, lamotrigine, congenital long QT syndrome. Recent MI, primidone, clobazam, ethosuximide, tiagabine, uncompensated HF. Pregnancy, lactation. B Bradycardia, electrolyte disturbances. If alprazolam, corticosteroids, doxycycline, dihydropyridines, haloperidol, other neuroleptic cardiac symptoms occur, a cardiac evaluation drugs, TCAs, trazodone, topiramate, methadone, should be performed. Neuroleptic malignant tramadol, anticoagulants, bromperidol, syndrome and torsade de pointes have been olanzapine, quetiapine, praziquantel, caspofungin, reported rarely. Tardive extrapyramidal syndrome fentanyl, midazolam, phenazone, propranolol, after long-term treatment, reduce dose or methylphenidate, flunarizine, quinidine and discontinue. History of seizures, hepatic hydroquinidine, tacrolimus, sirolimus, cyclosporine, impairment. Patients with risk factors for stroke. oral contraceptives, HRT, bupropion, psychotropic Contains lactose. Ability to drive or operate drugs, paracetamol, lithium, hypokalaemic machinary my be impaired. Women of child diuretics (loop and thiazide diuretics), bearing potential should use contraception. C Contra: Class IA and III antiarrhythmics, antiarrhythmics, muscle relaxants, isotretinoin, thyroid hormones, serotonin re-uptake inhibitors, arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, clozapine, procarbazine, alcohol. A Blood dyscrasias, dizziness, somnolence, gatifloxacin, moxifloxacin, dolasetron mesylate, sedation, drowsiness, ataxia, elevated gamma-GT, mefloquine, sertindole, cisapride, drugs that fatigue. prolong the QT interval. Caution: CNS drugs, alcohol, ketoconazole, carbamazepine. GEROZAC Gerard A Restlessness, dystonia, akathisia, 2NO extrapyramidal disorder, parkinsonism, tremor, SSRI. Fluoxetine (HCl) 20mg, 60mg. 20mg: Purple/ dizziness, sedation, somnolence, headache, vision green cap. marked FL20. 60mg: Light yellow blurred, GI disorders, musculoskeletal rigidity, opaque cap. marked FL60 on the body and G on asthenia, fatigue. the cap. 20mg-30, A15.02; 60mg-30, A65.45. GERICARB SR Gerard S Major depressive episodes and associated anxiety. Bulimia nervosa. Obsessive 2MO compulsive disorders (OCD). Dibenzazepine. Carbamazepine 200mg, 400mg. P Depression: Usually 20mg daily. Bulimia White to yellowish, round, flat, cloverleaf shaped nervosa: 60mg daily. OCD: 20-60mg daily. Max. prolonged release tabs with bevelled edge, double-sided cross break-mark, 4 notches on band. daily dose 80mg. R Max. 60mg daily. Can be divided into equal halves. 200mg-56, Q Not recommended. A4.48; 400 mg-56, A8.85. B Contains lactose. See fluoxetine Drug S Prophylaxis of manic or hypomanic Prescribing Notes. phases of manic-depressive psychosis in patients sweating, tremor, induction of glaucoma, testicular disorders, skin rash, nausea, vomiting.
unresponsive or with contraindications to lithium therapy. P Initially 100-400mg, increased gradually until symptoms controlled or to a total of 800mg. Exceptionally, max 1600mg in divided doses. Maintenance: 400-600mg daily in divided doses. D Bone marrow depression, AV conduction abnormalities, acute intermittent porphyria. B Evaluate benefit/risk: Haematological disturbances, disturbed Na+ metabolism, severe cardiac, liver and kidney dysfunction, myotonic dystrophia, pregnancy, lactation. Patients should consult immediately if fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, skin yellowing and liver enlargement occurs. Caution: Severe cardiovascular disease, liver disease or renal damage,
OCD
3.4
months or longer in some cases. Hepatic/renal impairment, reduce dose 25-50% (see SPC). Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes.
LAMICTAL
GSK
2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Pale yellow, multi-faceted, superelliptical tabs. marked with strength and code on reverse. 25mg56, A25.21; 50mg-56, A39.57; 100mg-56, A68.26; 200mg-56, A122.88.
2MO
ALSO LAMICTAL DISPERSIBLE Lamotrigine 2mg, 5mg, 25mg, 50mg, 100mg, 200mg. White tabs. marked with strength and code on reverse. 2mg30, A6.49; 5mg-28, A8.95; 25mg-56, A25.21; 50mg-56, A39.38; 100mg-56, A68.26; 200mg-56, A123.91. S Prevention of depressive episodes in patients with bipolar I disorder (BD), who predominantly have depressive episodes. P Monotherapy or adjunctive therapy without valproate or enzyme inducers: Initially, 25 mg/day (once a day) for 2 weeks; followed by 50 mg/day (once a day or two divided doses) for 2 weeks; then 100 mg/day (once a day or two divided doses) for 1 week; thereafter usual maintenance dose, 200 mg/day (once a day or two divided doses). Adjunctive therapy with valproate: Initially, 12.5 mg/day (25 mg on alternate days) for 2 weeks; followed by 25 mg/day (once a day) for 2 weeks; then 50 mg/day (once a day or two divided doses) for 1 week; thereafter maintenance dose 100 mg/day (once a day or two divided doses). Adjunctive therapy with enzyme inducers (except valproate): Initially 50 mg/day (once a day) for 2 weeks; followed by 100 mg/day (two divided doses) for 2 weeks; then 200 mg/day (two divided doses) for 1 week; thereafter 300mg/day, increasing to 400mg/day if necessary (2 divided doses). See SPC for dosing of lamotrigine during withdrawal or addition of concomitant psychotropic drugs. Q Safety and efficacy in BP not evaluated. B Renal/hepatic impairment. Rare skin reactions e.g. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidal ideation and behaviour. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ ritonavir, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. IREVEN Teva A Headache, agitation, somnolence, dizziness, dry mouth, skin rash, arthralgia, pain, 2NO back pain. 5HT/NA reuptake inhibitor. Venlafaxine (HCl) 75mg, 150mg. Resp. flesh and scarlet opaque hard LAMORO Pinewood gelatine prolonged-release caps containing two 2MO and three round, biconvex film-ctd tabs marked Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. VEN on cap and strength on body. 75mg-28, A20.23; 150mg-28, A34.68. Dispersible white to off-white round tabs. 25mg60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; S Major depressive episodes. 200mg-60, A96.11. P Swallow whole with liquid once daily same time each day during meal. Initially, 75mg. S Prevention of mood episodes in patients May be increased to 150mg, then to 225mg. with bipolar disorder (BP), predominantly by Patients not responding, doses up to 375mg preventing depressive episodes. (limited experience). Increase doses at intervals of P Monotherapy or add on therapy to 2 weeks or more with min. 4 days between each drugs with no interaction with lamotrigine e.g. increment. If no response after 2-4 weeks, no lithium: Initially 25mg once daily for 2 weeks, benefit to be gained from treatment. Duration 4-6 followed by 50mg once daily or 2 divided doses
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
103
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidality (increased risk below 18 years). Pregnancy, lactation. Driving/operating machinery. Contains lactose. C Valproate reduces dose requirement. May increase dose requirement: Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination (consider continuous hormonal contraceptives or non-hormonal contraceptives to limit variations in lamotrigine levels). A Headache, agitation, somnolence, dizziness, dry mouth, skin rash, arthralgia, pain, back pain.
symptoms resolve (usually 2-4 weeks), continue for at least 6 months. OCD: Initially 10mg once daily, may be increased to max. 20mg daily; treat for sufficient period to ensure patient is symptom free. Panic disorder, GAD, SAD: See section 3.2. Reduced hepatic function: Initially 5mg for 2 weeks, may increase to 10mg. R Over 65 years, initially half adult dose and lower max. dose. Q Under 18 years, not recommended. B Hyponatraemia observed with SSRI use. History of mania/hypomania, co-admin. of ECT in patients on SSRI’s, bleeding disorders, coronary heart disease, paradoxical anxiety. Monitor patients with unstable epilepsy, diabetes. Withdraw gradually. Closely monitor patients for LARIG Rowex suicide and self harm during initiation of therapy (all SSRIs). Driving/using machine. Pregnancy, 2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. lactation. C Contra: Non-selective, irreversible White, square dispersible tab. marked L and MAOIs. Reversible MAOI-A (moclobemide), not strength. 25mg-56, A19.57; 50mg-56, A30.56; recommended. Caution: Selegiline, lithium, 100mg-56, A52.97; 200mg-56, A96.15. S Prevention of mood episodes in patients tryptophan, St. John’s Wort, drugs lowering epilepsy seizure threshold, oral anticoagulants, with bipolar disorder, predominantly by cimetidine, substrates or inhibitors of CYP2C19 preventing depressive episodes. (eg. omeprazole), CYP2D6 substrates, other P Monotherapy or add on therapy to serotonergic drugs, alcohol. drugs with no interaction with lamotrigine eg. A Nausea, sweating, somnolence, fatigue, lithium: Initially 25mg once daily for 2 weeks; dizziness, insomnia, constipation, diarrhoea, target dose, 200mg once daily or in 2 divided appetite decrease, sexual dysfunction, pyrexia, doses (range 100-400mg). Add on therapy with sinusitis, yawning. enzyme inhibitors e.g. valproate: Initially 25mg on alternate days for 2 weeks; target dose, 100mg LUSERT Pinewood once daily or in two divided doses; max. 200mg 2NO daily. Add on therapy with enzyme inducers eg. SSRI. Sertraline (HCl) 50mg, 100mg. White, film-ctd carbamazepine and without valproate: Initially tabs. 50mg, oval biconvex with breakline on the 50mg once daily for 2 weeks; usual target dose side and S3 on opposite side. 100mg, round bevel400mg daily in two divided doses (may be given edged with breakline. 50mg-28, A21.00; 100mgfrom week 7). See SPC for dose escalation in all LAMOTRIGINE RANBAXY Ranbaxy cases. See SPC for dosing of lamotrigine during 28, A31.55. 2MO S Major depressive episodes. withdrawal of concomitant psychotropic drugs. P Usually 50mg daily; may be increased in Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Hepatic impairment: Moderate, half adult dose; 50mg steps at min. 1 week intervals. Max. 200mg White to off-white round tab., debossed with L12, severe, 1/4 adult dose. daily. Max. effect after 2-4 weeks. Continue at L13, L14 or L15 (resp.) on one side. 25mg-56, Q Under 18 years, not recommended. A13.44; 50mg-56, A21.10 ; 100mg-56, A36.40; least 6 months after symptom remission. To be B Renal/hepatic impairment. Rare skin 200mg-56, A66.51. reactions eg. Stevens Johnson syndrome. Promptly taken with sufficient liquid. Reduce gradually to avoid withdrawal symptoms. S Adults q 18 years: Prevention of evaluate patients who develop rash. R Lowest dosage possible. depressive episodes in patients with bipolar I Hypersensitivity syndrome. Pregnancy, lactation Q Under 18 years, not recommended. disorder experiencing predominantly depressive (only if benefit outweighs risk). Driving/using D Severe hepatic impairment, unstable episodes Not indicated for acute treatment of machines. Withdraw gradually. epilepsy. manic or depressive episodes. C Enzyme inducing anti-epileptic drugs P Monotherapy or adjunctive therapy (AEDs) (eg. phenytoin, primidone, carbamazepine, B Hepatic impairment, controlled epilepsy, ECT, diabetes, history of bleeding disorder, without valproate or enzyme inducers: Initially phenobarbitone) may increase dose requirement. unstable cardiac disease, schizophrenia, elderly. 25mg once daily for 2 weeks, followed by 50mg A Rash, irritability, headache, drowsiness, Monitor for risk of suicide. Serotonin syndrome. once daily or 2 divided doses for 2 weeks; then insomnia, dizziness, tremor, vision disorders, GI Suicidal Symptoms among children under 18 years. 100mg/day for 1 week; thereafter 200mg daily, disorders, tiredness, arthralgia, pain, back pain. Monitor for risk of dependence symptoms. once daily or in 2 divided doses; may be increased Activation of mania/hypomania. Pregnancy, up to 400mg. Adjunctive therapy with valproate: lactation (only if benefit outweighs risk). Driving/ Initially 12.5mg )or 25mg on alternate days) for 2 using machines. weeks, followed by 25mg once daily for 2 weeks; C Contra: MAOIs (14 days apart), then 50mg/day (once daily or in 2 divided doses); pimozide. Avoid St John’s wort, serotonergics (eg. thereafter 100mg daily, once daily or in 2 divided trypthophan, fenfluramine, 5-HT agonists), doses, may be increased up to 200mg max. LEXAPRO Lundbeck alcohol. Caution: Cimetidine, diazepam, Adjunctive therapy with enzyme inducers: Initially 2NO tolbutamide, hypoglycaemics, oral anticoagulants, 50mg once daily for 2 weeks, followed by 100mg drugs affecting platelet function (e.g. NSAIDs, in 2 divided doses daily for 2 weeks, then 200mg/ SSRI. Escitalopram (oxalate) 5mg, 10mg, 15mg, 20mg. Round white film-ctd tab. marked EK and most TCAs), lithium, diuretics, phenytoin, day for 1 week; thereafter increasing by 100mg oval white scored film-ctd tabs. marked with EL, sumatriptan, CYP2D6 substrates, warfarin, per week up to target maintenance dose of EM and EN, resp. 5mg-28, A14.00; 10mg-28, phenozone (antipyrine), changeover from other 400mg/day in 2 divided doses. See SPC for dosing A22.40; 15mg-28, A33.90; 20mg-28, A44.80. antidepressants. during withdrawal or addition of concomitant A GI disorders, dry mouth, dyspepsia, psychotropic drugs. Special patient populations: S Major depressive episodes. Generalised tremor, dizziness, insomnia, somnolence, anorexia, See SPC. anxiety disorder (GAD). Panic disorder with or male sexual disorders, tiredness, hot flushes, skin Q Not recommended. without agoraphobia. Social anxiety disorder rash, increased sweating, chest pain, palpitations, B Renal failure (caution). Rare skin (SAD). Obsessive-compulsive disorder (OCD). tinnitus, headache, asthenia, motor disorders, reactions eg. Stevens Johnson syndrome. Promptly P Depression: Usually 10mg once daily, paraesthesia, hypoaesthesia, anxiety, yawning, evaluate patients who develop rash. may be increased to max. 20mg daily. After for 2 weeks; thereafter 100-200mg daily, once daily or in 2 divided doses. Target maintenance dose, 200mg; but may be increased up to 400mg. Add on therapy with enzyme inhibitors e.g. valproate: Initially 25mg on alternate days for 2 weeks, followed by 25mg once daily for 2 weeks; thereafter 50-100mg daily, once daily or in 2 divided doses. Target maintenance dose, 100mg; but may be increased up to 200mg. Add on therapy with enzyme inducers e.g. carbamazepine: Initially 50mg once daily or 2 divided doses for 2 weeks, followed by 100mg in two divided doses daily for 2 weeks, thereafter patients may be increased by 100mg per week up to max. 400mg in two divided doses. Target maintenance dose, 400mg. See SPC for dosing of lamotrigine during withdrawal or addition of concomitant psychotropic drugs. Special patient populations: Refer to SPC. Q Safety and efficacy in BP not evaluated. B Renal/hepatic impairment. Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hormonal contraceptives. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for clinical worsening and suicidality. Driving/operating machinery. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Skin rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, diplopia, blurred vision, GI disturbance, tiredness, agitation, arthralgia, somnolence, pain, back pain.
104
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
reported in children and adolescents. Caution with: Epilepsy and organic brain syndrome, hepatic or renal failure, heart disease, hypotension, MIRAP Rowex micturition disturbances, acute narrow-angle 2NO glaucoma and raised intra-ocular pressure, GI 2 N O SSRI. Sertraline (HCl) 50mg, 100mg. White, capobstruction or ileus, diabetes mellitus, tendency to shaped, film-ctd tabs. marked PFIZER and ZLT-50 Presynaptic a2-antagonist. Mirtazapine 15mg, suicidal ideation. Elderly. Driving/using machines. or ZLT-100 resp. 50mg tab. scored. 50mg-28, 30mg, 45mg. Film-coated, biconvex tabs. 15mg, Discontinue if jaundice occurs. Withdraw A12.63. 100mg-28, A18.94. 30mg: Yellow and beige, resp; both oval with score line on one side. 45mg: White, round. 15mg- gradually. Contains aspartame. S Treatment of symptoms of depression, C MAOIs (within 2 weeks), alcohol. 30, A12.41; 30mg-30, A20.65; 45mg-30, A37.20. incl. accompanying symptoms of anxiety. Caution: Benzodiazepines and other sedatives, Prevention of relapse of initial depressive episodes 2 N O other serotonergic drugs, potent CYP3A4 or recurrence of further depressive episodes, ALSO MIRAP ORODISPERSIBLE TABLETS inhibitors, CYP3A4 inducers, cimetidine, warfarin. including accompanying symptoms of anxiety. Mirtazapine 15mg, 30mg, 45mg. White to offA Increased appetite and weight gain, Obsessive compulsive disorder in adults and white, round, flat tabs with bevelled edges and somnolence, dizziness, headache, oedema. children aged 6 years and over. Panic disorder plain on both sides. 15mg-30, A10.67; 30mg-30, with or without agoraphobia. Social anxiety A21.32; 45mg-30, A31.98. MIRTAZAPINE TEVA Teva disorder (SAD). Post-traumatic stress disorders S Major depressive episodes. 2NO (PTSD). P Initially, 15-30mg preferably in the P OCD/Depression: 50mg once daily. Panic evening. Maintenance,15-45mg per day. Renal or Presynaptic a2-antagonist. Mirtazapine 15mg, disorder/SAD/PTSD: Initially, 25mg daily increasing hepatic insufficiency: Also consider divided dose in 30mg, 45mg. Round, white, bevelled edge tab. to 50mg daily after 1 week. All indications: Dose marked 93 one side and 7303, 7304 or 7305, resp. the morning and at bedtime (larger dose). Effect may be increased in 50mg increments over a usually after 1-2 weeks. Withdraw gradually if no on the other. 15mg-30, A9.84; 30mg-30, A19.68; period of weeks, to max. 200mg daily. 45mg-30, A29.51. effect with max. dose after 2-4 weeks. Take tabs Q OCD: Age 13-17 years, 50mg/day; 6-12 S Major depressive episode. with sufficient water; orodisp. tabs with or years, initially 25mg/day, increasing to 50mg/day P Initially, 15mg or 30mg, in the evening. without water. after 1 week. Patients not responding, increase by R Changes in dosage under close Maintenance dose 15mg-45mg per day. 50mg/day increments at 1 week intervals; max. Q Under 18 years, not recommended. supervision. 200mg/day. Under 6 years: Not recommended D Lactation, pregnancy (unless clearly Q Under 18 years, not recommended. D Significant hepatic insufficiency. indicated). D Pregnancy (unless clearly indicated), Pregnancy, lactation. Unstable epilepsy or B Monitor for signs of bone marrow lactation. convulsant disorders. B Monitor patients with history of suicide- depression (discontinue if occurs). Suicide-related B Monitor for suicidality during 1st few related events or exhibiting a significant degree of behaviours and hostility more frequently reported weeks of treatment. Discontinue if patient enters in children and adolescents; monitor patients with suicidal ideation. Monitor for bone marrow depression; discontinue if fever, sore throat, a manic phase. Controlled epilepsy. ECT, not history of suicide-related events, or exhibiting stomatitis or other signs of infections occur. recommended. Monitor children for suicidality if suicidal ideation prior to commencement. Caution: Caution: epilepsy and organic brain syndrome, treating for OCD. Driving or using machines. Epilepsy and organic brain syndrome, hepatic or hepatic and renal impairment, cardiac diseases C Contraindicated: MAOIs (or within 14 renal failure, heart disease, hypotension, GI (conduction disorders, angina pectoris, recent MI), obstruction or ileus, micturition disturbances, days), pimozide. Monitor alcohol, lithium, hypotension, prostate hypertrophy, acute narrow- acute narrow-angle glaucoma and increased IOP, warfarin, phenytoin, sumatriptan. Caution: St angle glaucoma and elevated intra-ocular Johnâ&#x20AC;&#x2122;s wort, diazepam, tolbutamide, cimetidine, diabetes, elderly. May occur: Exacerbation of pressure, diabetes mellitus, elderly, history of TCAs, other centrally acting drugs, other psychotic symptoms, switch to manic phase of mania/hypomania (discontinue if patient enters a serotonergic drugs. bipolar disorder (discontinue). Withdrawal manic phase). May worsen psychotic symptoms in symptoms may occur following abrupt A Anorexia, insomnia, dizziness, patients with schizophrenia or other psychotic somnolence, tremor, GI disorders, increased termination. Discontinue if jaundice occurs. sweating, ejaculatory delay. Also reported in OCD disorders. Discontinue if jaundice occurs. Withdraw Contains aspartame. Driving/operating machines. gradually. Driving/using machines. Tabs contain patients aged 6-17 years: Chest pain, fever, C Contra: MAOIs (or within two weeks). malaise, hyperkinesia, urinary incontinence, other lactose. Orodisp. tabs contain aspartame and Caution: Benzodiazepines and other sedatives, sulphites. psychiatric disorders, breast pain, dysmenorrhea, other serotonergic drugs (e.g. SSRIs), potent C Contra: MAOIs (or within 2 weeks after CYP3A4 inhibitors, HIV protease inhibitors, azole menstrual disorder, epistaxis, skin disorder, discontinuation). Avoid alcohol. Caution: headache, hyperkinesia. antifungals, erythromycin or nefazodone, CYP3A4 Benzodiazepines and other sedatives, other inducers (e.g. carbamazepine, rifampicin, MANERIX Roche serotonergic drugs, strong CYP3A4 inhibitors, phenytoin), cimetidine, warfarin. Avoid alcohol. CYP3A4 inducers, cimetidine, warfarin. A Increased appetite and weight gain, 2NO A Increased appetite, weight gain, somnolence, dizziness, headache, generalised or RIMA (reversible inhibitor of monoamine oxidase somnolence, dizziness, headache, general or local local oedema. A). Moclobemide 150mg, 300mg. Oblong, pale oedema, nausea. yellow film-ctd scored tab. marked ROCHE and MIRZATEN Niche tab. strength on reverse. 150mg-30, A11.18; MIRTAZ Pinewood 2 N O 300mg-30, A17.93. 2NO Presynaptic a2-antagonist. Mirtazapine 15mg, S Moderate or severe depression. 30mg or 45mg. White, round, biconvex Presynaptic a2-antagonist. Mirtazapine 30mg. P Initially 300mg daily in divided doses orodispersible tablets. 15mg-30, A10.93; 30mg-30, White or off-white round orodispersible tab. after meals, max. 600mg daily. A A19.19; 45mg-30, A32.14. marked M2. 30, 22.52. Q Not recommended. S Episode of major depression. S Major depressive episodes. D Acute confusional states. Patients with P Initially, 15-30mg dissolved on the P Initially, 15 or 30mg per day, taken concomitant schizophrenia. Pregnancy and tongue once daily at bedtime. Maintenance,15preferably in the evening. The maintenance dose lactation, unless benefits outway risks. 45mg per day. May be taken twice daily, with is usually between 15-45mg per day. B Depressive patients with excitation, larger dose in the evening. Treatment duration, 4- Q Under 18 years, not recommended. suicidal tendencies, epilepsy. Thyrotoxicosis or 6 months. Withdraw gradually if no effect with D Lactation, pregnancy (unless clearly phaeochromocytoma. See SPC. max. dose after 2-4 weeks. indicated). C Ibuprofen, opiates, cimetidine. CoQ Under 18 years, not recommended. B Monitor for signs of bone marrow admin. with 5-HT re-uptake inhibitors or D Pregnancy (unless clearly indicated), depression (discontinue if occurs). Suicide-related precursors not recommended. lactation. behaviours reported in children and adolescents. A Sleep disturbances, dizziness, nausea, Caution: Epilepsy and organic brain syndrome, headache have occasionally been observed. In very B Monitor for bone marrow depression (discontinue if occurs). Suicide-related behaviours hepatic or renal failure, heart disease, rare cases confusional states have been reported. Some anti-cholinergic-like effects have been reported.
agitation, menstrual disorders, impaired vision.
LUSTRAL
106
Pfizer
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
3.4
hypotension, GI obstruction or ileus, micturition disturbances, acute narrow-angle glaucoma and raised intra-ocular pressure, diabetes mellitus, schizophrenia, history of mania/hypomania, elderly. Discontinue if icterus occurs. Withdrawal symptoms may occur following abrupt termination. Contains aspartame, lactose and sorbitol. Driving/using machines. C MAOIs (contraindicated). Avoid alcohol. Caution: Benzodiazepines and other sedatives, other serotonergic drugs, potent CYP3A4 inhibitors, CYP3A4 inducers, cimetidine, warfarin. A Increased appetite and weight gain, somnolence, dizziness, headache, generalised or local oedema.
necessary after one week to 1 three times daily. Maintenance, usually 1 daily. Q Not recommended. D See SPC.
2NO
R Max. 40mg daily. PROTHIADEN Teofarma Q Under 18 years, not recommended. 2NO D Children Q18 years with major TCA. Dothiepin (HCl) 25mg. Red/brown cap. depressive episodes. B Hepatic/severe renal impairment, cardiac marked P25. 100, A4.62; 500, A22.01.
condition, increased risk of bleeding, history of mania, epilepsy, ECT, narrow angle glaucoma, diabetes; caution. Serotonin syndrome, akathisia, hyponatraemia may develop. High risk of suicidal behaviour. Withdraw gradually. Pregnancy, PAROSER Pinewood lactation; only if clearly necessary (risk of serotonergic effects/withdrawal symptoms in 2NO neonates). Driving/using machines. SSRI. Paroxetine (HCl anhydrate) 22.2mg equiv. C Contra: MAOIs (2 weeks apart), 20mg paroxetine. White, oval-shaped, biconvex, film-ctd tabs. engraved 20 with a breakline on one thioridazine, tryptophan. Caution: St John’s Wort, SSRIs, tramadol, other serotonergics, CYP2D6 side. 30, A15.00. substrates (eg. phenothiazine neuroleptics, certain S Major depressive episode, obsessive compulsive disorder (OCD), panic disorder with or TCAs, risperidone, certain 1c antiarrhythmics, metoprolol), alcohol, anticoagulants, NSAIDs, without agoraphobia, Social Anxiety Disorders lithium, procyclidine. (SAD)/social phobia, Generalised Anxiety Disorder A Sexual dysfunction, nausea, decreased (GAD). MOLIPAXIN sanofi-aventis P Once daily in the morning with food. appetite, body weight gain, asthenia, somnolence, yawning, insomnia, dizziness, tremor, blurred 2MO Depression, SAD/social phobia, GAD: vision, GI disorders, sweating. Recommended dose 20mg daily; max. 50mg/day. Triazolopyridine. Trazodone (HCl) 150mg. Pink OCD: 40mg daily. Initially 20mg daily; max. 60mg/ film-ctd scored tab. marked Molipaxin 150. 28, PRIADEL Sanofi A11.88. day. Panic disorder: 40mg daily. Initially 10mg 2NO daily; max. 60mg/day. All doses should be 2MO increased if necessary in 10mg increments. Lithium salt. Lithium carbonate 200mg, 400mg. ALSO MOLIPAXIN CAPSULES Trazodone (HCl) Duration several months or longer for OCD, panic Prolonged release tabs. marked P200 and PRIADEL 50mg, 100mg. Violet/green and violet/fawn cap. resp. Both white scored tabs. 200mg-100, A2.96; disorder; at least six months for depression. A coded R365B and R365C resp. 50mg-84, 17.71; 400mg-100, A4.36. R Max. 40mg/day. 100mg-56, A20.85. S Acute manic or hypomanic episodes, Q Under 18 years, not recommended. S Depression with or without anxiety. depressive disorders where other antidepressants D Pregnancy, lactation (unless absolutely P Initially 75-150mg daily as single failed, prophylaxis of bipolar affective disorders, evening dose, increasing to 200-300mg per day by necessary). control of aggressive behaviour or intentional self end of 1st week. Hospitalised patients with severe B Severe renal impairment (cc Q30ml/ harm. min), hepatic impairment. Increase of suicidal depression, increase to max. 600mg daily in P Initially 400-1200mg daily as a single related behaviours. History of mania, cardiac divided doses. dose. Maintain blood lithium levels in range 0.7conditions, diabetes, epilepsy, increased risk of R Initially 100mg daily in divided doses 1mmol/litre 12 hours after a single daily dose. See after meals or as single night-time dose. Max. bleeding, hyponatraemia reversible on SPC. 300mg daily. discontinuation, narrow angle glaucoma. Q Not recommended. Q Under 18 years. not recommended. Associated with akathisia, Serotonin Syndrome/ D Pregnancy, lactation. Neuroleptic Malignant Syndrome. Contains lactose. O B Suicide and suicidal ideation. Epilepsy. ALSO PRIADEL LIQUID Lithium citrate 520mg Discontinue gradually. Driving / using machines. Severe hepatic, renal or cardiac disease. May C MAOIs, thioridazine, pimozide (contra), (equiv. to 5.4mmol Li+) per 5ml. Sugar free liquid. provoke bradycardia and hypotension. metoprolol, alcohol (avoid). Caution: Serotonergic 150ml, A7.81. Agranulocytosis, thrombocytopenia and anaemia. drugs, lithium, drug metabolising enzyme P Initially 10-30ml daily in two divided Alterations in liver function. Contains lactose. doses. Maintain serum lithium levels in range 0.5inhibitors, procyclidine, anticonvulsants, CYP2D6 Fructose intolerance, glucose-galactose 0.8 mmol/litre 12 hours after previous dose. See substrates (eg. certain TCAs, phenothiazine malabsorption or sucrase isomaltase insufficiency. SPC. neuroleptics, risperidone, certain Type lc Driving/operating machinery. Q Not recommended. antiarrhythmics), NSAIDs, drugs increasing C MAOIs, ketoconazole, ritonavir, D Cardiac failure. Renal impairment. bleeding risk. indinavir, carbamazepine, muscle relaxants, Addison’s disease. Untreated hypothyroidism. A Decrease appetite, somnolence, volatile anaesthetics, alcohol, sedatives, Pregnancy, lactation. insomnia, agitation, dizziness, tremor, blurred antidepressants, clonidine, antihypertensives, B Monitor renal, cardiac, thyroid function vision, yawning, GI disorders, sweating, sexual hypericum perforatum, digoxin, phenytoin. prior to treatment and periodically during. Elderly dysfunction, asthenia, body weight gain. Preparations containing St. John’s Wort. (caution). Check for signs of toxicity and advise A Suicidal ideation/behaviour, dizziness, PAROX Rowex patients about symptoms. Maintain salt and fluid headache, weakness, decreased alertness, weight intake. Advise patients to report polyuria, 2NO loss, tremor, dry mouth, tachycardia, oedema, GI polydipsia nausea, vomiting, diarrhoea, excessive SSRI. Paroxetine (HCl) 20mg, 30mg. White and disorders, rash, blurred vision, restlessness, sweating and/or other conditions leading to salt/ blue tabs. marked 20 and 30 resp. Both oval confused states, insomnia, skin rash. water depletion. Contains Na+. biconvex film-ctd with a breakline. 20mg-30, C Thiazide diuretics, steroids, NSAIDs, ACE A A 15.00; 30mg-30, 22.53. NORZAC Teva inhibitors, metronidazole, methyldopa, S Major depressive episode, obsessive 2NO compulsive disorder (OCD), panic disorder with or tetracyclines, osmotic diuretics, carbonic anhydrase SSRI. Fluoxetine (HCl) 20mg. Light green cap. 30, inhibitors, xanthine, Na+ bicarbonate, Ca++ channel without agoraphobia, social anxiety disorders A13.53. blockers, psychotropic/neuroleptic drugs, (SAD)/social phobia, generalised anxiety disorder S Depression. Bulimia nervosa. carbamazepine, triptan derivatives, serotoninergic (GAD), post-traumatic stress disorder. P Depression, single dose of 20mg daily. antidepressants. P Depression, SAD, social phobia, GAD, Bulimia nervosa, 60mg daily; max. 80mg daily. A Skin reactions, muscle weakness, CNS post-traumatic disorders: 20mg once daily in the Q Not recommended. morning with food; may be increased gradually in and ECG disturbances, GI disorders, thyroid D Severe renal failure, unstable epilepsy. function disturbances, weight increase, QT 10mg increments to max. 50mg once daily. OCD See fluoxetine Drug Prescribing Notes. and panic disorder: Initially 20mg once daily (OCD) prolongation, leucocytosis, polydipsia and/or or 10mg daily (panic disorder); increase weekly in polyuria, diabetes insipidus, confusion, peripheral PARNATE Goldshield 10mg increments to 40mg daily; max. 60mg daily. oedema. MAOI. Tranylcypromine (as sulph.) 10mg red sugctd tab. marked FW 251. 28, A14.79. S Depression. P Initially 1 twice daily, increasing if
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
107
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
SSRI. Fluoxetine (HCl) 20mg. Ivory cap. 30, A14.78. S Major depressive episodes and associated anxiety. Bulimia nervosa. Obsessive compulsive disorder (OCD). P Depression: usually 20mg daily. Bulimia nervosa: 60mg daily. OCD: 20-60mg daily, max. 80mg daily. Q Not recommended. D Severe renal failure, unstable epilepsy, convulsive disorders. See fluoxetine Drug Prescribing Notes.
outweighs risk). Driving /using machines. Withdraw gradually. C Contra: MAOIs (or within 14 days), 2NO pimozide. Avoid alcohol, serotonergics, St John’s ALSO PROTHIADEN TABLETS Dothiepin (HCl) wort. Caution: Lithium, diuretics, drugs increasing 75mg. Red sug-ctd tab. marked P75. 28, A3.62; the risk of haemorrhages (e.g. anticoagulants, 100, A12.33. TCAs, NSAIDs), tolbutamide, insulin, diazepam, P 75-150mg daily in divided doses or as cimetidine, phenytoin, sumatriptan, ECT. single dose in the evening. A GI disorders, dyspepsia, dry mouth, R Initial dose: 50-75mg daily. Increase sweating, tremor, dizziness, insomnia, somnolence, gradually under close supervision. anorexia, headache, motor disorders, yawning, Q Not recommended. agitation, anxiety, male sexual disorders, D See SPC. PROZIT Pinewood menstrual disorders, tiredness, asthenia, hot flushes, rash, chest pain, palpitations, tinnitus, PROZAC Lilly 2 N O impaired vision. 2NO SSRI. Fluoxetine (HCl) 20mg. Olive green cap. SSRI. Fluoxetine (HCl) 20mg. Green/yellow cap. marked FLE 20. 30, A15.00. SERIMEL Clonmel marked Lilly 3105. 30, A9.02. S Major depressive disorders, obsessive 2NO 2NO compulsive disorder, bulimia nervosa. See SSRI. Sertraline (HCl) 50mg, 100mg. White, film-ctd ALSO PROZAC LIQUID Fluoxetine (HCl) 20mg/5ml. fluoxetine Drug Prescribing Notes. caplet-shaped tab. marked with strength on one 70ml, A21.82. P Usually 20mg daily. Most patients do side and breakline on reverse. 50mg-28, A16.24; S Major depressive episodes, obsessive not require more than 20mg daily. Max. 60mg compulsive disorders (OCD), bulimia nervosa. daily. Bulimia nervosa: 60mg. Hepatic impairment: 100mg-28, A29.37. P Admin. as single or divided dose. Consider lower/less frequent dose (e.g. 20mg every S Major depressive episodes. P Usually 50mg daily; may be increased in Depression: Initially, 20mg daily; may be increased 2nd day). Gradually taper when discontinuing to 50mg steps at min. 1 week intervals. Max. 200mg after 3 weeks if no response. Range 20-60mg/day. avoid withdrawal symptoms. daily. Max. effect after 2-4 weeks. Continue at OCD: Initially 20mg daily; may be increased after 2 R Caution. Max dose 60mg/day. least 6 months after symptom remission. weeks if no response. Range 20-60mg/day. Q Not recommended. Q Under 18 years, not recommended. Reconsider after 10 weeks if no response. Bulimia nervosa: 60mg daily. SERETRAL Teva D Severe hepatic impairment, unstable epilepsy. Q Under 18 years, not recommended. 2NO B Hepatic impairment, history of mania/ B Contains sucrose. See fluoxetine Drug SSRI. Sertraline (HCl) 50mg, 100mg. Light blue or hypomania, controlled epilepsy, ECT, diabetes, Prescribing Notes. yellow, elliptical, film-ctd tab. one side scored and history of bleeding disorder, unstable cardiac disease, schizophrenia, elderly. Monitor for risk of PROZAMEL Clonmel marked 9 and 3, the other marked 7176 or 7177 resp. 50mg-30, A17.94; 100mg-30, A28.42. suicide. Serotonin syndrome. Pregnancy, lactation 2NO S Major depressive episodes. (only if essential). Driving/using machines. SSRI. Fluoxetine (HCl) 20mg. Green cap. 30, P 50mg/day once daily with sufficient Withdraw gradually. A13.78. liquid. Can be increased in steps of 50mg at min 1 C Contra: MAOIs (14 days apart), S Major depressive episodes and week intervals. Max, 200mg/day. Max. effect pimozide. Avoid St John’s wort, serotonergics (eg. associated anxiety. Bulimia nervosa. Obsessive generally reached after 2-4 weeks. Consider long- tryptophan, fenfluramine, 5-HT agonists), alcohol. compulsive disorders (OCD). term treatment, at least 6 months, after remission Caution: Cimetidine, diazepam, tolbutamide, P Depression: usually 20mg daily. Bulimia of symptoms. hypoglycaemics, oral anticoagulants, drugs nervosa: 60mg daily. OCD: 20-60mg daily. Max. Q Under 18 years, not recommended. affecting platelet function (e.g. NSAIDs, most daily dose 80mg. TCAs), lithium, diuretics, phenytoin, sumatriptan, D Severe hepatic impairment. Unstable Q Not recommended. CYP2D6 substrates, changeover from other epilepsy (avoid). D Severe renal failure. Unstable epilepsy, B Monitor for risk of suicide. Activation of antidepressants. convulsive disorders. See fluoxetine Drug A GI disorders, dry mouth, dyspepsia, mania or hypomania. Impaired hepatic function Prescribing Notes. tremor, dizziness, insomnia, somnolence, anorexia, (use lower or less frequent dose), controlled male sexual disorders, asthenia, tiredness, hot epilepsy, schizophrenia, heart disease, diabetes, PROZATAN UCB patients at risk of haemorrhage, elderly. Akathisia flushes, sweating, rash, chest pain, palpitations, 2NO tinnitus, headache, motor disorders, paraesthesia, reported. Pregnancy, lactation (only if benefit S Depression, anxiety associated with depression.
Drug Prescribing Notes ● FLUOXETINE Indications Major depressive episodes ● Obsessive-compulsive disorder ● Bulimia nervosa Special Precautions Under 18 years of age: Suicide-related behaviours. Caution with: History of seizures (avoid if unstable seizure disorders/epilepsy), history of mania/hypomania. Discontinue in any patient who develops seizures or enter manic phase ● Significant hepatic dysfunction (lower dose) ● Acute cardiac disease (limited data) ● Suicidal ideation (monitor carefully, especially early treatment and change of dose) ● Discontinue gradually ● patients with a history of bleeding disorders ● Avoid driving/using machines. Pregnancy: Data on a large number of pregnancies do not indicate a teratogenic effect of fluoxetine. Can be used during pregnancy, but caution should be exercised, especially during late pregnancy or just prior to the onset of labour, since side-effects have been reported in neonates. Lactation: Excreted in human breast milk. Adverse events reported in breast-feeding infants. Consider discontinuation of breast-feeding or use lowest effective dose. Drug Interactions Contraindicated: Treatment of fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI and the following day after discontinuation of a reversible MAOI-A. Similarly, at least 5 weeks should elapse after discontinuing fluoxetine treatment before starting a MAOI. If fluoxetine has been prescribed chronically and/or at a high dose, a longer interval should be considered. Avoid: Alcohol. Caution: Oral anticoagulants, drugs increasing risk of bleeding, phenytoin, CYP2D6 isoenzyme with narrow therapeutic index (e.g., flecainide, encainide, carbamazepine, TCAs), ECT. Risk of serotonin syndrome (monitoring recommended): St John's Wort, MAOI-B (selegeline), other serotonergics (e.g., L-tryptophan), lithium. Side-Effects Hypersensitivity, chills, serotonin syndrome, photosensitivity, GI disorders, headache, sleep abnormalities, dizziness, anorexia, fatigue, euphoria, transient abnormal movement, seizures, hallucinations, manic reaction, confusion, agitation, anxiety, impaired concentration and thought process, panic attacks, suicidal thoughts and behaviour, urinary retention/frequency, sexual dysfunction, priapism, galactorrhoea, alopecia, yawn, abnormal vision, sweating, vasodilatation, arthralgia, myalgia, postural hypotension, ecchymosis, pharyngitis, dyspnoea. Revised November 2009
108
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
MOOD
DISORDERS, BULIMIA NERVOSA,
tryptophan, fenfluramine, tramadol, St John’s wort. Caution: Centrally active drugs, lithium, sumatriptan, phenytoin, TCAs, drugs affecting SERLAN Rowex platelet function (e.g. anticoagulants, NSAIDs), tolbutamide, diazepam, cimetidine, insulin. 2NO A Anorexia, insomnia, dizziness, SSRI. Sertraline (HCl) 50mg, 100mg. White, cap.somnolence, tremor, diarrhoea, dry mouth, shaped, scored, film-ctd tab. marked SE/strength. dyspepsia, nausea, sweating, sexual dysfunction. 50mg-28, A18.45; 100mg-28, A31.54. S Major depressive episodes. SEROQUEL XR AstraZeneca P Usually 50mg daily; may be increased in 50mg steps at min. 1 week intervals. Max. 200mg 2 N O Dibenzothiazepine. Quetiapine (fumarate) 50mg, daily. Max. effect after 2-4 weeks. Continue at 200mg, 300mg, 400mg. Prolonged released tabs. least 6 months after symptom remission. Peach, yellow, pale yellow and white resp. marked Q Under 18 years, not recommended. with XR and strength. 50mg-60, A63.08; 200mgD Severe hepatic impairment, unstable 60, A140.80; 300mg-60, A213.89; 400mg-60, epilepsy and seizures. A 282.13. B Hepatic impairment, history of mania/ S Moderate to severe manic episodes and hypomania, controlled epilepsy, ECT, diabetes, major depressive episodes in bipolar disorder. history of bleeding disorder, unstable cardiac disease, schizophrenia, elderly. Monitor for risk of Prevention of recurrence in responsive patients. P Manic: Admin. at least 1 hr before meal. suicide. Serotonin syndrome. Pregnancy, lactation Initial titration: 300mg (day 1), 600mg (day 2) (only if benefit outweighs risk). Driving/using ( q recommended dose). Dose range 400-800mg/ machines. Withdraw gradually. day. Depressive: Admin once daily at bedtime. C Contra: MAOIs (14 days apart), pimozide. Avoid St John’s wort, serotonergics (eg. 50mg (day 1), 100mg (day 2), 200mg (day 3), 300mg (day 4) ( q recommended daily dose); trypthophan, 5-HT agonists, dextromethrophan, pethidine, tramadol, other SSRIs), alcohol. Caution: may be titrated up to 600mg or down to 200mg. Maintenance: Same dose, can be adjusted within Anticoagulants, drugs affecting platelet function range 300-800mg/day. Hepatic impairment: Initially (eg. NSAIDs, TCAs, phenothiazides), lithium, 50mg/day; can be increased in increments of sumatriptan, diuretics, hypoglycaemic drugs, 50mg/day. phenytoin, cimetidine, diazepam, tolbutamide, R Initially 50mg/day; can be increased in some CYP2D6 substrates (eg. propafenone, increments of 50mg/day to effective dose. Over 65 flecainide). years, not evaluated for depressive episodes. A Anorexia, weight loss, male sexual Q Children and adolescents, not evaluated. disorders, insomnia, somnolence, agitation, 2NO anxiety, tremor, dizziness, paraesthesia, ALSO SEROQUEL Quetiapine (fumarate) 25mg, hypoaesthesia, headache, blurred vision, chest 100mg, 200mg, 300mg. Film ctd tabs. Peach, pain, palpitations, vasodilatation, yawning, GI yellow, white and white resp. 25mg-60, A37.77; disorders, dry mouth, dyspepsia, rash, menstrual 100mg-60, A107.92; 200mg-60, A123.04; 300mgirregularities, diaphoresis, fatigue. 60, A200.04. SERLO Actavis S Moderate to severe manic episodes and major depressive episodes in bipolar disorder. Not 2NO indicated for prevention of recurrence. SSRI. Sertraline (as HCl) 50mg, 100mg. Oval and P Manic: Admin. twice a day. Initial round white, scored, biconvex, film-ctd tabs. titration: 100mg (day 1), 200mg (day 2), 300mg marked with L and C resp. 50mg-28, A17.76; (day 3), 400mg (day 4). Further adjustments should 100mg-28, A27.40. be in increments of no greater than 200mg/day. S Depression (treatment and prevention Usual effective dose 400-800mg/day. Dose range of relapses). Treatment of obsessive-compulsive 200-800mg/day. Depressive: See Seroquel XR. disorder (OCD), panic disorder with/without Hepatic impairment: Initially 25mg/day; should be agoraphobia, social phobia and prevention of increased in increments of 25-50mg/day. relapse of initial episode, post-traumatic stress R Dose titration may need to be slower disorder (PTSD). and daily therapeutic dose lower. P Depression, OCD: 50mg daily. Panic Q Children and adolescents, not disorder , social phobia, PTSD: Initially 25mg daily; recommended. increase to 50mg daily after 1 week. Increase in B Monitor for suicidal tendencies, esp. at 50mg steps at min. 1 week intervals up to max. beginning. Caution: Hepatic impairment, 200mg daily. Full effect after 2-4 weeks. cardiovascular or cerebrovascular disease, Q Under 6 years, not recommended. OCD: hypotension, history of seizures, patients at risk 13-17 years, initially 50mg daily. 6-12 years initially for aspiration pneumonia. Monitor diabetic 25mg daily; increase to 50mg daily after 1 week. patients. May increase metabolic risk. May occur: Max. 200mg daily. Other indications: Under 18 Tardive dyskinesia, neuroleptic Monitor for suicidal years, not recommended. tendencies, esp. at beginning. Caution: Hepatic D Significant hepatic dysfunction, epilepsy impairment, cardiovascular or cerebrovascular or convulsant disorders. Pregnancy, lactation. disease, hypotension, history of seizures, patients B Monitor for suicidal tendencies, esp. at at risk for aspiration pneumonia. Monitor diabetic beginning. Activation of mania or hypomania patients. May increase metabolic risk. May occur: (discontinue). Monitor renal function regularly, Tardive dyskinesia, neuroleptic malignant especially in elderly. Controlled epilepsy (stop if syndrome, lipid changes. Driving/operating convulsions occur), ECT (not recommended), machines. Pregnancy (only if benefit outweighs diabetes, patients at risk of haemorrhage. Driving/ risk), lactation (avoid). XR tab. contain lactose. using machines. Withdraw gradually. C Contra: CYP3A4 inhibitors (eg. HIVC Contra: MAOIs (14 days apart), protease inhibitors, azole antifungals, erythromycin, clarithromycin, nefazodone). pimozide. Avoid alcohol, serotonergics e.g. hyperaesthesia, anxiety, agitation, menstrual disorders, impaired vision.
OCD
3.4
Caution: Hepatic inducers (eg. carbamazepine, phenytoin), other centrally acting drugs, alcohol, thioridazine. Avoid grapefruit juice. A Leucopenia, hyperprolactinaemia, increased appetite, abnormal dreams and nightmares, dizziness, somnolence, headache, syncope, tachycardia, blurred vision, orthostatic hypotension, rhinitis, GI disorders, withdrawal symptoms, mild asthenia, peripheral oedema, irritability, decreased neutrophil count, weight gain. Elevations in: ALT, AST serum triglyceride, total cholesterol, blood glucose. Decrease in HDL cholesterol.
SEROXAT
GSK
2NO SSRI. Paroxetine (HCl) 10mg, 20mg, 30mg. 10mg, white to pinkish round tab. marked FC1 on one side and GS on reverse. 20mg, white oval scored tab. marked Seroxat 20. 30mg, blue oval scored tab. marked Seroxat 30. All film-ctd. 10mg-28, A17.36, 20mg-30, A9.02; 30mg-30, A13.52.
2NO ALSO SEROXAT ORAL SUSPENSION Paroxetine (HCl) 20mg/10ml. 150ml, A24.00. S Treatment and prevention of relapse of depressive illness (incl. depression accompanied by anxiety), obsessive compulsive disorder (OCD) and panic disorder with or without agoraphobia. Treatment of generalised anxiety disorder (GAD) and post traumatic stress disorder. P Depression/GAD/post traumatic stress disorder: 20mg once daily. May be increased gradually by 10mg increments to max. 50mg once daily. OCD/panic disorder: Initially 20mg once daily. Increase weekly in 10mg increments to 40mg daily. Max. 60mg daily. Renal insufficiency or chronic hepatic dysfunction: 20mg daily. Take all doses in the morning with food. R Adult starting dose. May be increased weekly in 10mg increments to max. 40mg daily. Q Under 18 years, not recommended. B History of mania, severe renal impairment, hepatic impairment, cardiac disease, diabetes, epilepsy, narrow angle glaucoma, history of glaucoma. May occur: Serotonin syndrome (discontinue), increased suicide risk, akathisia, hyponatraemia (caution if at risk), haemorrhagic manifestations (especially elderly, history of bleeding disorders). Withdraw gradually. ECT. Pregnancy (use only when strictly indicated), lactation. Oral suspension contains parabens, sunset yellow, sorbitol. C Contraindicated: MAOIs (within 2 weeks; moclobemide and linezolid, within 24 hrs), thioridazine, pimozide. Metropolol, not recommended. Caution: Serotonergic drugs (tryptophan, triptans, tramadol, linezolid, SSRIs, lithium, St John’s Wort), TCAs, phenothiazine neuroleptics, risperidone, atomoxetine, type 1c antiarrhythmics (propafenone, flecainide), tamoxifen (consider using alternative antidepressant), anticoagulants, NSAIDs/acetyl salicylic, antiplatelet agents. Antacids, proton pump inhibitors, histamine H2 receptor antagonists (oral suspension only). Avoid alcohol. A Increased cholesterol levels, decreased appetite, somnolence, insomnia, agitation, dizziness, tremor, headache, blurred vision, yawning, GI disturbances, dry mouth, sweating, sexual dysfunction, asthenia, weight gain, tinnitus, suicidal ideation/ behaviours.
SERTRANICHE
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
Niche
109
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
initiation, after around 6 weeks, after around 12 and 24 weeks and thereafter when indicated. Jaundice (discontinue). Severe or moderate renal impairment (limited data). Contains lactose. Pregnancy. Driving/using machines. C Contra: Potent CYP1A2 inhibitors (eg. TEGRETOL Novartis fluvoxamine, ciprofloxacin). Caution: Moderate CYP1A2 inhibitors (eg. propranolol, 2MO grepafloxacine, enoxacine), alcohol (avoid). Dibenzazepine. Carbamazepine 100mg white A Headache, migraine, dizziness, scored tab. marked B/W on one side and GEIGY somnolence, insomnia, fatigue, anxiety, GI on reverse; 200mg white scored tab. Marked C/G disorders, hyperhidrosis, back pain. on one side and G/K on reverse; 400mg white oblong tab. scored and marked CG/CG one side Rowex and scored with tab. name on reverse. 100mg-100, VEDIXAL 2NO A4.16. 200mg-100, A7.69. 400mg-50, A7.57; 400mg-56, A8.47. 5HT/NA reuptake inhibitor. Venlafaxine (as hydrochloride) 37.5mg, 75mg. Pale red-brown 2MO oblong tab. coded 3 and scored tab. coded 7 on ALSO TEGRETOL ORAL SUSPENSION each half, resp. 37.5mg-56, A18.07; 75mg-56, Carbamazepine 100mg/5ml. Sugar-free liquid. A30.13. 300ml, A7.27. S Treatment of mania and prophylaxis of S Treatment of depressive illness including depression accompanied by anxiety. Prevention of manic-depressive psychosis. Alcohol withdrawal relapses of the intial episode of depression or symptoms. prevention of the recurrence of new episodes. V Mania and manic-depressive illness, P To be taken with food. Initiation and initially 100-200mg daily in divided doses maintenance: 75mg. May be increased to 150mg increasing gradually until symptoms controlled; per day in 2 divided doses if needed. In more max. 1600mg daily. severely depressed or hospitalised patients, 150mg 2MO in 2 divided doses may be given initially and ALSO TEGRETOL RETARD Carbamazepine 200mg increased by up to 75mg every 2 or 3 days until beige-orange cap.-shaped scored controlleddesired response achieved. Max dose: 375mg/day. release Divitab marked TEGRETOL 200 one side and HC/HC on reverse; 400mg brown-orange cap.- Gradually reduce to usual dosage according to patient response and tolerance. Moderate renal/ shaped scored controlled-release Divitab marked hepatic impairment, reduce dose by 50%. TEGRETOL 400 one side and ENE/ENE on reverse. R Use lowest effective dose. 200mg-50, A4.76; 400mg-50, A9.37. Q Under 18 years, not recommended. V Same total daily dose as above but in D Children and adolescents under 18 years two divided doses. with Major Depressive Disorder. For other D AV conduction abnormalities unless SURMONTIL sanofi-aventis paced. prescribing information, see venlafaxine Drug Presc. Notes. 2NO B Cardiac hepatic or renal disease. TCA. Trimipramine (maleate) 25mg. White to pale Perform liver function tests periodically. Blood VEDIXAL XL Rowex dyscrasias. Pregnancy, lactation. Test blood yellow, circular, biconvex, film-ctd tab., marked 2NO SURMONTIL on one side and 25 reverse. 25mg-50, regularly. C MAOIs, anticoagulants, antiepileptics, 5HT/NA reuptake inhibitor. Venlafaxine (as A5.12. lithium, macrolide antibiotics (erythromycin), some hydrochloride) 37.5mg, 75mg, 150mg. Resp. light S Depression where sleep disturbance, Ca++ antagonists (verapamil, diltiazem), grey, flesh-coloured and orange prolonged-release anxiety or agitation are present. dextropropoxyphene, viloxazine, cimetidine, hard caps. containing white to off-white pellets. 2NO isoniazid, oral contraceptives, alcohol. 37.5mg-7, A3.04; 75mg-28, A17.47; 150mg-28, ALSO SURMONTIL CAPSULES Trimipramine A29.45. A Gastric upset, diplopia, dry mouth, (maleate) 50mg. Green hard cap. marked SU 50. drowsiness and dizziness. Oedema and S Major depressive episodes. 28, A5.75. P Swallow whole with food. Effective P 50-100mg as single dose, 2 hours before hyponatraemia. Blood dyscrasias, rashes, acute renal failure, hepatitis. See SPC. dose 75-225mg. Initially, 75mg. May be increased retiring. to 150mg, then to 225mg if unsatisfactory Q Not recommended. VALDOXAN Servier response. Patients not responding, doses up to D Known risk of narrow angle glaucoma. 375mg (limited experience). Increase doses at 2NO Risk of urinary retention related to urethroprostatic disorders. Recent MI. Pregnancy & Melatonergic agonist. Agomelatine 25mg. Orange- intervals of 2 weeks or more with a minimum of 4 days between each increment. If no response after yellow, oblong, film-ctd tab. marked with lactation (unless essential). 2-4 weeks, no benefit to be gained from company logo. 28, A37.80. B Caution: Elderly, history of epilepsy or treatment. Treatment usually requires 4-6 months S Major depressive episodes. recent convulsions, urinary retention, glaucoma, of therapy or longer in some cases. Hepatic/renal P 25mg once daily at bedtime. After 2 hyperthyroidism, cardiovascular disorders, blood impairment, reduce dose (see SPC). Patients with weeks of treatment, if no improvement may be dyscrasis, alcoholism, pre-existing brain damage, increased to 50mg once daily at bedtime. Treat for cardiovascular disorder/ hypertension, as per ECT, patients more susceptible to postural at least 6 months. No dosage tapering needed on elderly. hypotension and sedation, chronic constipation R Start with lowest effective dose. discontinuation. (risk of paralytic ileus), prostatic hypertrophy, Q Under 18 years, not recommended. R 65 years and over, caution. Do not use hepatic/renal insufficiency. May occur: D Patients at high risk of a serious cardiac in elderly patients with dementia. Cardiovascular and hepatic adverse events. Keep ventricular arrhythmia or uncontrolled Q Under 18 years, not recommended. patients with severe depression under close hypertension. Children and adolescents under 18 D Hepatic impairment (i.e. cirrhosis or surveillance. Insomnia or nervousness at the start years. Other prescribing information, see active liver disease). Lactation. of treatment may require reduced doses or venlafaxine Drug Presc. Notes. B History of mania or hypomania transient symptomatic treatment. Discontinue if sudden manic episodes occur. Monitor for suicidal (discontinue if manic symptoms develop). Monitor VENEX XL Clonmel suicidal behaviour or thoughts. Elevations of behaviour. Contains lactose. 2NO serum transaminases (discontinue if q 3xULN); C Contra: Sulpiride. Not recommended: 5HT/NA reuptake inhibitor. Venlafaxine perform liver function tests in all patients at Alcohol, clonidine and related compounds, a and
2NO
SSRI. Sertraline 50mg, 100mg. White film-ctd tabs. 50mg: Oval, slightly biconvex, scored on one side and marked with S3 on reverse. 100mg: Round, bevel-edged, scored. 50mg-28, A17.84; 100mg-28, A29.21. S Major depressive episodes. P Usual dose, 50mg daily; may be increased to 100mg daily, max. 200mg. Max. effect seen after 2-4 weeks. Continue treatment at least 6 months after symptom remission. Q Under 18 years, not recommended. D Severe hepatic impairment, unstable epilepsy. B Monitor for risk of suicide. Caution: History of mania/hypomania, controlled epilepsy, ECT, diabetes, bleeding abnormalities, cardiac disease, schizophrenia, elderly. Potential for serotonin syndrome. Pregnancy/lactation (only if benefit outweighs risk). Driving/using machines. Withdraw gradually. C Contra: MAOIs incl. moclobemide and selegiline (14 days apart), pimozide. Avoid: St Johnâ&#x20AC;&#x2122;s wort, serotonergics (e.g. tryptophan, fenfluramine and 5-HT agonists), alcohol. Caution: oral anticoagulants, drugs affecting platelet function (e.g. NSAIDs, most TCAs, phenothiazines), lithium, diuretics, phenytoin, sumatriptan, cimetidine, diazepam, tolbutamide, hypoglycaemic drugs, changeover from use of other antidepressants. A GI disorders, dyspepsia, dry mouth, sweating, headache, motor disorders, paraesthesia, hypoaesthesia, insomnia, somnolence, anorexia, sexual disorders, tiredness, hot flushes, skin rash, chest pain, palpitations, tinnitus, agitation, anxiety, menstrual disorders, impaired vision.
110
b sympathomimetics. Caution: Antiepileptics, serotoninergic antidepressants, antihypertensives, atropine and other atropinic substances, other CNS depressants, thalidomide, guanethidine, zopiclone. A See SPC.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
3.4
less than 4 days. Maintain lowest effective dose. Continue treatment for at least 6 months following remission. Mild and moderate hepatic impairment: consider 50% dose reduction. Severe 2NO hepatic impairment: Caution, consider q50% dose 5HT/NA reuptake inhibitor. Venlafaxine 37.5mg, 75mg. Peach coloured, mottled, uncoated, shield- reduction. Renal impairment: 30ml/minQccQ70ml/ min, caution. ccQ30ml/min, 50% dose reduction. shaped tab. debossed with V and 2 or V and 4, R Use lowest effective dose; careful resp., on one side. 37.5mg-56, A19.94; 75mg-56, monitoring. A33.26. S Treatment of major depressive disorder Q Not recommended. incl. depression accompanied by anxiety. Following D Identified very high risk of serious cardiac ventricular arrhythmia (significant left initial response, prevention of relapses of the ventricular dysfunction, NYHA Class III/IV) or initial episode of depression or prevention of uncontrolled hypertension, closed-angle glaucoma, recurrence of new episodes. micturition disorders (obstruction of urinary flow). P Take with food and sufficient fluid at same time each day. 75mg/day in 2 divided doses. B For prescribing information, see May be increased to 150mg/day in 2 divided doses venlafaxine Drug Presc. Notes. (75mg twice daily). Increase dose only after clinical VENLOFEX Gerard evaluation and at least 3-4 weeks of therapy. 2NO Maintain lowest effective dose. In more severely depressed or hospitalised patients, may be 5HT/NA reuptake inhibitor. Venlafaxine HCl eq. to increased by up to 75mg/day every 2 or 3 days 75mg, 150mg. Resp. flesh or scarlet opaque hard until desired response achieved (close supervision). prolonged-release cap. marked VEN on one side In patients requiring r300mg, initiate treatment and 75 or 150 on the other. 75mg-28, A22.79; under specialist supervision. Max 375mg/day. 150mg-28, A38.48. Prevention of relapse or for prevention of S Major depressive episodes. recurrence of a new episode: Dosage similar to P Swallow whole with food. Effective that used during index episode; regularly re-assess dose 75-225mg. Initially, 75mg. May be increased benefit of long-term therapy. Renal impairment to 150mg, then to 225mg. Patients not VENLAFAXINE TEVA Teva (GFR 10-70mg/ml): Reduce dose by 25-50%. responding, doses up to 375mg (limited 2NO Moderate hepatic impairment (PT 14-18 seconds): experience). Increase doses at intervals of 2 weeks Reduce dose by 50%. Severe renal/hepatic or more with 4 days min between increments. If 5HT/NA reuptake inhibitor. Venlafaxine (HCl) impairment: Insufficient data, consider reducing no response after 2-4 weeks, no benefit to be 37.5mg, 75mg. Contains lactose. Mottled peach, gained from treatment. Treatment usually requires round, flat bevelled tabs scored and marked 9 on dose by q 50%. Not suitable for haemodialysis patients. 4-6 months of therapy or longer in some cases. one side of score and 3 on reverse. On opposite R Start with lowest effective dose. Renal impairment (GFR 10-70ml/min): Reduce dose side of tab: 37.5mg marked with 7380; 75mg Q Under 18 years, not recommended by 25-50%. Severe renal impairment (cc Q 30ml/ marked with 7382. Only 75mg can be divided into min) and haemodialysis: Half dose, postpone (increased risk of suicide related behaviours). equal halves. 37.5mg-56, A21.67; 75mg-56, administration until dialysis is completed. Mild2NO A36.12. moderate hepatic impairment: Reduce dose by ALSO VENLIFT XL Venlafaxine 75mg, 150mg. S Major depressive episodes. 50%. Resp. size 1 or size 0 cap. with pink or caramel P Swallow whole with liquid once daily R Start on the lowest recommended dose. opaque cap and body marked RVn on cap and same time each day during meal. Initially, 75mg. Q Under 18 years, not recommended. strength on body in black ink. 75mg-28, A19.28; May be increased to 150mg, then to 225mg. B For prescribing information, see 150mg-28, A32.51. Patients not responding, doses up to 375mg (limited experience). Increase doses at intervals of S Treatment of major depressive episodes. venlafaxine Drug Presc. Notes. Prevention of recurrence of major depressive 2 weeks or more with min. 4 days between each VENSIR XL Morningside episodes. increment. If no response after 2-4 weeks, no 2NO benefit to be gained from treatment. Duration 4-6 P 75mg once daily with food and sufficient fluid at the same time each day. May be 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) months or longer in some cases. Hepatic/renal increased to 375mg/day maximum at interval of 2 75mg, 150mg. 75mg: Peach opaque hard cap. with impairment, reduce dose 25-50% (see SPC). red radial circular bands, filled with 6 white to weeks or more. If clinically warranted, dosage Q Under 18 years, not recommended. increased intervals may be more frequent, but not off-white round biconvex film-ctd mini tabs. B For prescribing information, see
hydrochloride eq. to 37.5mg, 75mg, 150mg. Resp. size 3 with an orange cap, size 1 with a yellow cap and size 0 with a buff cap prolonged-release transparent cap. containing white to off white granules. 37.5mg-28, A10.10; 75mg-28, A14.80; 150mg-28, A24.84. S Major depressive episodes. P Swallow whole with food. Effective dose 75-225mg. Initially, 75mg. May be increased to 150mg, then to 225mg if unsatisfactory response. Patients not responding, doses up to 375mg (limited experience). Increase doses at intervals of 2 weeks or more with a minimum of 4 days between each increment. If no response after 2-4 weeks, no benefit to be gained from treatment. Treatment usually requires 4-6 months of therapy or longer. Renal impairment (GFR 1070ml/min): Reduce dose by 25-50%. Haemodialysis: Half dose, postpone administration until dialysis is completed. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. R Start on lowest recommended dose. Q Under 18 years, not recommended. B For prescribing information, see venlafaxine Drug Presc. Notes. Contains sucrose. 37.5mg cap. contains ponceau 4R red. 75mg and 150mg cap. contain sunset yellow.
venlafaxine Drug Presc. Notes.
VENLIFT
Ranbaxy
Drug Prescribing Notes ● VENLAFAXINE Special Precautions Monitor for suicidality, especially in early treatment and following dose changes. Monitor serum cholesterol. Withdraw gradually. Caution with: ● History of mania/ hypomania or aggressive behaviour ● Seizure (discontinue if occurs) ● Elderly (regular and careful check-ups, especially if dehydrated or taking diuretics) ● Diabetes (dose of antidiabetics might have to be adjusted) ● Moderate-severe renal impairment or hepatic cirrhosis ● Narrow-angle glaucoma (monitor patients with raised IOP) ● Micturition disorders (e.g. prostate hypertrophy, very small probability of problems) ● High or low BP (monitor) ● Myocardial ischaemia, acute cerebrovascular disease or other cardiac disease ● Increased risk of bleeding ● Driving and using machines. Pregnancy: Limited experience does not suggest any increased risk of congenital abnormalities or any other adverse reactions on pregnancy or the unborn child; however, animal studies have shown reproductive toxicity. The potential risk for humans is unknown. Venlafaxine should not be used during pregnancy unless clearly necessary. Lactation: Venlafaxine and its active metabolite are excreted into breast milk. It is not clear what the effects of this are for the nursing infant. Therefore, a decision should be made whether to continue/discontinue breast-feeding or to continue/discontinue therapy with venlafaxine, taking into account the benefit of breast-feeding to the child and the benefit of venlafaxine therapy to the mother. Drug Interactions Contraindicated: MAOIs (or within 14 days). Avoid: Alcohol, weight loss agents. Caution: Serotonergics (e.g. triptans, linezolide, SSRIs, lithium), antipsychotics, alpha- and beta-sympathomimetics, St John’s wort, ECT, anticoagulants, clozapine, cimetidine (in elderly/hepatic dysfunction), indinavir, haloperidol. Potent CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, cimetidine, verapamil) or drug combinations that inhibit both CYP3A4 and CYP2D6 should only be co-administered with venlafaxine if strictly indicated. Risk of hyponatraemia in patients receiving diuretics. Side-Effects Hypertension, vasodilatation, ecchymosis, mucous membrane bleeding, GI disorders, dry mouth, impaired micturition, asthenia, sweating, headache, increased serum cholesterol, weight loss, reduced appetite, dizziness, drowsiness, increased muscular tone, paresthesia, sedation, tremor, insomnia, nervousness, abnormal dreams, abnormal ejaculation/orgasm, anorgasmia, erectile dysfunction, decreased libido, yawning, abnormal vision, accommodation disorders, mydriasis. Revised November 2009
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
111
3.5 NAUSEA,
VOMITING, VERTIGO
150mg: Dark orange hard cap. with white radial circular bands, filled with 12 white to off-white round biconvex film-ctd mini tas. 75mg-28, A17.47; 150mg-28, A29.45. S Major depressive disorder. Prevention of relapses of initial episode of depression or prevention of recurrence of new episodes. P Swallow whole with liquid. Take with food. Major depressive disorder: Effective dose 75150mg/day. Initially, 75mg. If clinical response unsatisfactory, may be increased after 3 weeks. In more severely depressed or hospitalised patients, daily dose may be increased by up to 75mg every 2 or 3 days. Max recommended dose: 375mg. Prevention of relapse or recurrence: Dose similar to that used during index episode; re-assess regularly benefit of long-term therapy. Moderate renal impairment (GFR 10-30ml/min): Reduce dose by 50%. Mild-moderate hepatic impairment: Reduce dose by 50%; further reduction may be required in some patients. Severe renal impairment/ severe hepatic impairment: Insufficient data. R Use lowest effective dose, carefully monitor dose increases. Q Under 18 years, not recommended. D Very high risk of serious cardiac ventricular arrhythmia, uncontrolled hypertension. For prescribing information, see venlafaxine Drug Presc. Notes.
XANAX
Pharmacia
2NO Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White, pink and lavender oval scored tabs. marked UPJOHN 29, UPJOHN 55 and UPJOHN 90 resp. 0.25mg-100, A2.11; 0.5mg100, A4.06; 1mg-100, A8.48. S Anxiety when the disorder is severe, disabling or causing extreme distress. P 0.5-1mg daily in divided doses, increasing in increments not greater than 1mg every 3-4 days to 3-4 daily. Max. treatment duration, 8-12 weeks. R 0.25mg twice daily. Q Not recommended. D Myaesthenia gravis, severe respiratory or hepatic insufficiency sleep apnoea syndrome. B Tolerance, physical and psychic pendence, anterograde amnesia, psychiatric and paradoxical reactions (e.g restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares) C Alcohol, CNS depressants. A Amnesia, drowsiness, depression, pychiatric and paradoxical reactions, dependence.
CNS
patient completely symptom-free for 4-6 months. Swallow tab. with sufficient amount of water. Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. B Monitor for signs of bone marrow depression. Caution: Epilepsy and organic brain syndrome, hepatic or renal insufficiency, cardiac diseases, hypotension, micturition disturbances, acute narrow-angle glaucoma and increased intraocular pressure, diabetes mellitus, schizophrenia, history of mania/hypomania, elderly. Discontinue if jaundice occurs. Contains lactose. Driving/using machines. C MAOIs (contraindicated), alcohol (avoid). Caution: Benzodiazepines, other SSRIs, potent CYP3A4 inhibitors, CYP3A4 inducers, warfarin. A Increase in appetite and weight gain, somnolence, dizziness, headache, oedema.
Driving/operating machines. C Caution: Drugs increasing QT interval. A Headache, GI disorders, dizziness.
ZISPIN
DOMERID
Schering-Plough
2NO Presynaptic a2-antagonist. Mirtazapine 30mg. Redbrown oval scored tab. marked Organon and coded TZ/5. 28, A11.57. S Episode of major depression. P Initially 15mg daily. Titrate according to response, usually 15-45mg. Q Not recommended.
2NO ALSO ZISPIN SOLTAB Mirtazapine 15mg, 30mg, 45mg. Round, white, standard bevelled-edge orodispersible tabs. with marked TZ/1, TZ/2), TZ/4 resp. 15mg-30, A6.95; 30mg-30, A13.89; 45mg-30, A20.83. P Daily dose 15-45mg. Initially 15mg or 30mg (preferably as single dose at night). Place tab. on tongue. Swallow disintegrated tab. with or without water. Q Not recommended. B Pregnancy, lactation (no data). Renal or hepatic impairment, epilepsy, organic brain syndrome, cardiac conduction disturbance, angina, recent MI, hypotension, prostatic hypertrophy, diabetes, glaucoma. Avoid driving. Elderly (caution). C MAOIs (wait 2 weeks after cessation), alcohol. Benzodiazepines (caution). A Increase of appetite, oedema, weight gain, drowsiness/sedation, dizziness, headache. Granulocytopenia. Warn patients to report signs of infection. Jaundice (discontinue).
BY-VERTIN
Ergha
2MO H1 agonist. Betahistine (HCl) 8mg, 16mg. 8mg white tab marked B8, 16mg white scored tab marked B16. 8mg-120, A5.64; 16mg-84, A7.91. S Vertigo, tinnitus, symptoms of Meniereâ&#x20AC;&#x2122;s syndrome. P 8-16mg three times daily; maintenance 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Peptic ulcer, asthma, urticaria, allergic rhinitis. C Antihistamines. A GI upset, headache, rash. Rowex
2MO Dopamine antagonist. Domperidone (maleate) 12.72mg equiv. 10mg of domperidone. White, round, biconvex tab. marked Dm10. 100, A6.03. S Nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort, regurgitation of gastric contents. P 1-2 three to four times daily before meal. Max. daily dose: 80mg. Initial duration: 4 weeks. Severe renal insufficiency (prolonged therapy), reduce dose to once or twice daily. Q Over 12 years and weighing 35kg or more, as for adults. Less than 35kg, unsuitable. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. B Lactose intolerance, galactosaemia or glucose/galactose malabsorption (unsuitable). Pregnancy. Lactation, hepatic impairment (not recommended). C CYP3A4 inhibitors. A Increase in prolactin levels.
EMEND
MSD
2NO
Anti-emetic. Aprepitant 125mg, 80mg. Both opaque hard caps. 125mg: White body and pink cap marked with 462 and 125mg. 80mg: White body and cap marked with 461 and 80mg. 3 day pack: 125mg-1 and 80mg-2, A60.91; 125mg-5, A101.53; 80mg-2, A40.61. S As combination therapy for the 3.5 NAUSEA, VOMITING, VERTIGO prevention of acute and delayed nausea and ALOXI Helsinn Birex vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and the 2JNO prevention of nausea and vomiting associated ZISMIRT Gerard 5-HT3 antagonist. Palonosetron (HCl) 250mcg/5ml. with moderately emetogenic cancer A89.25. Soln for inj. in vial. 5ml, 2NO chemotherapy. S Prevention of: Acute nausea and Presynaptic a2-antagonist. Mirtazapine 30mg. vomiting associated with highly emetogenic cancer P 125mg swallowed whole on day 1 and Normal convex, buff film-ctd tab. debossed MR 80mg once daily days 2 and 3 as part of regimen chemotherapy; nausea and vomiting associated scoreline 30 on one side and G on reverse. 28, incl. a corticosteroid and a 5-HT3 antagonist (see with moderately emetogenic cancer A19.29. SPC). Admin. orally 1 hour prior to chemotherapy chemotherapy. 2NO on day 1 and in the morning on days 2 and 3. P 250mcg admin. as single IV bolus over Q Under 18 years, not recommended. ALSO ZISMIRT OROTAB Mirtazapine, 15mg, 30mg, 30 secs approx. 30 mins before start of 2J or 45mg. White, round, orodispersible tabs chemotherapy. Do not repeat within 7 days. marked 36, 37 or 38 resp. 15mg-30, A11.04; 30mg- Highly emetogenic chemotherapy: Efficacy may be ALSO IVEMEND Fosaprepitant 115mg. White to 30, A22.53; 45mg-30, A33.99. off-white powder for solution for infusion. 10ml-1, enhanced by corticosteroid admin. prior to A33.64. S Episode of major depression. chemotherapy. P Initially 15 or 30mg. Effective dose P 115mg by IV infusion over 15 mins on Q Under 18 years, not recommended. usually between 15 and 45mg daily. May be given D Lactation, pregnancy (unless essential). Day 1 only as part of regimen incl. a corticosteroid in sub doses equally divided over the day (once in B History of constipation or signs of and a 5-HT3 antagonist. Admin 30 mins prior to the morning, once at night-time). Discontinue subacute intestinal obstruction; monitor. Existent/ chemotherapy. See SPC and Emend for Day 2 and risk of prolongation of QT interval; caution. gradually if no response within 2-4 weeks, or if 3.
112
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
NAUSEA,
P 8-32mg a day. Emetogenic chemo/ radiotherapy: 8mg intravenously (immediately) or orally (1-2 hours) before treatment, followed by 8mg orally 12 hours later. Continue with 8mg twice daily for up to 5 days. Highly emetogenic chemo/radiotherapy: 8mg orally twice daily or by IV injection (see relevant SPC), continued for up to 5 days after a course of treatment. PONV: Prevention, can admin. orally or by IV. Orally: 16mg as single dose, 1 hour prior to anaesthesia (or 8mg 1 hour prior followed by 2 further doses of 8mg 8 hourly). Treatment, IV admin. recommended. Moderate/severe hepatic impairment: Max. 8mg daily. Q Under 2 years, not recommended. 2-18 years: Chemo/radiotherapy: Single IV of 5mg/m2 over 15 mins. immediately before chemotherapy, followed by 4mg orally 12 hours later. Continue dose according to body area daily for up to 5 days after course of treatment. Body area 0.6-1.2m2, EMITAL Teva 4mg 3 times a day; over 1.2m2, 8mg 3 times a day. PONV: Parenteral administration recommended, 2NO see relevant SPC. Selective 5HT3 receptor-antagonist. Ondansetron D Hypersensitivity to other 5HT3 receptor (as HCl dihydrate) 4mg, 8mg. White to off-white, antagonists. Pregnancy, lactation. round biconvex film-ctd tabs. marked PA on one B Monitor patients with signs of subacute side and 933 and 934 resp. on reverse. 4mg-30, intestinal obstruction. Not indicated in children A126.16; 8mg-30, A187.61. after intra-abdominal surgery. Arrhythmias or S Nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for cardiac conduction disorders (no data). Adenotonsillar surgery (may mask occult prevention and treatment of post-operative bleeding). nausea and vomiting (PONV). P Emetogenic chemo/radiotherapy: Range C Caution: Antiarrhythmic agents or bblockers, phenytoin, carbamazepine, rifampicin, 8-32mg a day. 8mg 1-2 hrs before treatment, tramadol. followed by 8mg 12 hrs later. Then 8mg twice A Constipation, headache, flushing, IV inj. daily for up to 5 days. Highly emetogenic site reactions. chemotherapy: Rectal, IV or IM administration on day of treatment. Continue for up to 5 days with KYTRIL Roche 8mg orally twice daily. PONV: Prevention, 16mg 1 2N hr prior to anaesthesia; or 8mg 1 hr prior to anaesthesia followed by 2 further doses of 8mg at 5HT3 antagonist. Granisetron (HCl) 1mg/ml. 1ml, eight hourly intervals. Treatment, IV or IM admin. 3ml amps. for IV inf. 1ml, A82.73; 3ml, A209.38. S Prophylaxis or treatment of nausea and recommended. Moderate/severe hepatic vomiting induced by cytostatic therapy. 1mg/ml impairment: Max. 8mg daily. also indicated for management of post operative R PONV: Limited experience. nausea and vomiting. Q Emetogenic chemo/radiotherapy: 2-18 P Post-operative nausea and vomiting: 2 years, single IV dose of 5mg/m over 15 min just 1mg diluted to 5ml, by slow IV inj. (over 30secs.). before chemotherapy, followed by 4mg orally 12 hrs later. Then admin. oral treatment according to Repeat at intervals of 10mins. if necessary; max. 3mg in 24 hours. Chemotherapy induced nausea 2 body area for up to 5 days: 0.6-1.2m , 4mg three and vomiting: 3mg diluted to 15ml infusion, by times a day; q1.2m2, 8mg three times a day. slow IV inj. (over 30secs.) OR diluted to 20-50ml Under 2 years or body area Q0.6m2, not inf. by IV inf. over 5 mins. Repeat at intervals of recommended. PONV: Slow IV inj. recommended. D Children after intra-abdominal surgery. 10 min if necessary; max. dose 9mg in 24 hours. Q Single dose of 40mcg/kg body weights Pregnancy, lactation. (up to 3mg) by IV inf. diluted in 10-30ml inf. fluid B Hypersensitivity to other 5HT3 receptor and admin. over 5 mins. prior to start of cytostatic antagonists. Sub acute intestinal obstruction, therapy. One additional dose of 40mcg/kg body adenotonsillar surgery (may mask occult bleeding). weight (up to 3mg) may be admin. within a 24Contain lactose. hours period if required and not until at least 10 C Caution: Tramadol, potent CYP3A4 mins. after initial inf. inducers (i.e. phenytoin, carbamazepine, 2NO rifampicin). ALSO KYTRIL TABLETS Granisetron (HCl) 1mg, A Constipation, headache, sensations of 2mg. White triangular film-ctd tabs. 1mg-10, flushing or warmth, hiccups. A89.62; 2mg-5, A89.62. S Prevention of acute and delayed nausea EMIZOF Gerard and vomiting associated with cytostatic therapy. 2NO P 1mg twice daily or 2mg once daily for Selective 5HT3 receptor-antagonist. Ondansetron up to 1 week following therapy. First dose within (HCl dihydrate) 4mg, 8mg. Film-ctd yellow, round 1 hour before start of cytostatic therapy. biconvex tab.; marked 41, 42 resp. 4mg-30, Q Not recommended. A140.17; 8mg-10, A69.49. D Lactation. S Management of nausea and vomiting B Pregnancy. Subacute intestinal induced by cytotoxic chemotherapy and obstruction. radiotherapy. Prevention and treatment of postA Headache, constipation, lassitude, rash. Transient rise in liver enzymes. operative nausea and vomiting (PONV).
Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. B Moderate or severe hepatic insufficiency. Use non-hormonal contraception during, and for 2 months after treatment. Not to be administrated intramuscularly or subcutaneously, not to be given as a bolus injection (Ivemend). Emend contains sucrose. C Contra: Pimozide, terfenadine, astemizole or cisapride. Caution: Drugs metabolised by CYP3A4 and CYP2C9, corticosteroids, irinotecan, fentanyl, benzodiazepines, chemotherapeutic agents, immunosuppressants, oral contraceptives, ketoconazole, warfarin, tolbutamide, phenytoin, acenocoumarol. A Increased ALT and AST, headache, dizziness, hiccups, GI disorders, anorexia, asthaenia/fatigue.
VOMITING, VERTIGO
MAXOLON
3.5
Amdipharm
2MO Antidopaminergic. Metoclopramide monohydrochlor. 10mg. White to off-white scored tab. marked MAXOLON. 84, A6.36.
2MO ALSO MAXOLON SYRUP Metoclopramide (HCl) 5mg/5ml. 100ml, A1.60; 200ml, A3.20.
2NO ALSO MAXOLON INJECTION Metoclopramide (HCl) 5mg/2ml. Amp 12 x 5mg, A3.46. S Adults over 20 years: Nausea and vomiting associated with some cytostatic drugs and radiotherapy. Under 20 years: Vomiting associated with radiotherapy and intolerance to cytotoxic drugs. P 10mg three times daily. Q 15-19 years q60kg, 10mg three times daily; 30-59kg, 5mg three times daily; 9-14 years r30kg, 5mg three times daily; 5-9 years 20-29kg, 2.5mg three times daily; 3-5 years 15-19kg, 2mg two to three times daily; 1-3 year 10-14kg, 1mg two to three times daily; Q1year Q10kg, 1mg twice daily. D Phaeochromocytoma. Epilepsy. GI haemorrhage, mechanical obstruction or perforation. Pregnancy, lactation (unless essential). B Not for use in the immediate postoperative period (up to 3-4 days) following pyloroplasty or gut anastomosis. Assess risk/benefit: Significant hepatic or renal impairment, Parkinson’s disease. If vomiting persists, reassess patient to exclude underlying disorder (e.g. cerebral irritation). Caution: History of atopy (including asthma) or porphyria. May occur: Neuroleptic malignant syndrome, elevation of serum prolactin levels. Rare hereditary problems of galactose intolerance, Lapp lactose deficiency of glucose-galactose malabsorption. C Anticholinergics, phenothiazines, CNS drugs (MAOIs, sympathomimetics), serotonergic drugs, alcohol. A Extrapyramidal reactions.
MOTILIUM
McNeil Healthcare
2K Antidopaminergic. Domperidone 10mg. White to faintly cream circular biconvex film-ctd tabs. 10, A3.67; 20, A6.43.
2K ALSO MOTILIUM FASTMELTS Domperidone 10mg. White or off-white circular orodispersible tab. 10, A3.99; 20, A7.00. S Nausea. P Up to 10mg 3 times daily and at night for 2 weeks max. Q Under 16 years, not recommended. Over 16 years, as per adults. D Prolactin-releasing pituitary tumour (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. Hepatic and/or renal impairment. Pregnancy, lactation. B Contains aspartame. C Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, erythromycin). A Raised serum prolactin.
MOTILIUM RX
McNeil Healthcare
2OY Antidopaminergic. Domperidone 10mg. White film-ctd tab. marked M/10 on one side and JANSSEN on reverse. 100, A6.04.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
113
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VOMITING, VERTIGO
CNS
emetogenic chemotherapy: 8mg as slow IV inj. or inf. over 15 mins. immediately before chemotherapy, if necessary followed by 2 further IV 8mg doses 4 hours apart or continuous inf. of 1 mg/hour for 24 hrs. In some cases, initial dose may be increased to 32mg diluted with compatible inf. fluid as inf. over 15 mins. immediately before chemotherapy. Efficacy may be enhanced by simultaneous admin. of 20mg dexamethasone/ 2MO ALSO MOTILIUM SUSPENSION Domperidone 1mg glucocorticoids. PONV: Prevention, orally (16mg 1 hr prior to anaesthesia) or 8mg 1 hr prior to per ml. Oral susp. 200ml, A2.08. anaesthesia followed by 2 doses of 8mg at 8 hr S Nausea and vomiting. P 10-20ml 3 to 4 times daily before meals. intervals. Treatment, IV admin recommended. Moderate/severe hepatic impairment: Max. 8mg Max 80ml daily. Reevaluate after 4 weeks. daily. Q 0.25-0.5mg/kg body weight 3-4 times daily before meals to max. 2.4mg/kg daily. Do not Q Under 2 years, not recommended. 2-18 years: Chemo/radiotherapy: Single IV of 5mg/m2 exceed 80mg daily. Over 12 years and weighing body area over 15 mins. immediately before 35kg or more, as per adults. chemotherapy, followed by 4mg orally 12 hours 2MO later. Continue dose according to body area daily ALSO MOTILIUM SUPPOSITORIES Domperidone for up to 5 days after course of treatment. Body 10mg, 30mg, 60mg. 10mg-6, A1.80; 30mg-6, area 0.6-1.2m2, 4mg 3 times a day; over 1.2m2, A1.81; 60mg-6, A7.31. 8mg 3 times a day. PONV: Treatment and S Nausea and vomiting. prevention, slow IV inj. P 1 (60mg) suppos. 2 times daily. D Hypersensitivity to other 5HT3 receptor Q Over 12 years and weighing 35kg or antagonists. Children with body surface Q 0.6 m2. more, as per adults. Less than 5kg, not Lactation. recommended. 5-15kg, 10mg twice daily. More B Monitor patients with signs of subacute than 15kg, 30mg twice daily. intestinal obstruction. Arrhythmias or cardiac D Pregnancy (unless essential), lactation. Patients with prolactin releasing pituitary tumours, conduction disorders (no data). Adenotonsillar surgery (may mask occult bleeding). Contains GI haemorrhage, mechanical obstruction or lactose (tabs). Pregnancy. perforation. Hepatic impairment. C Caution: Antiarrhythmic agents or bB Severe renal insufficiency, especially if blockers, phenytoin, carbamazepine, rifampicin, prolonged use. tramadol. C Anticholinergics, CYP3A4 inhibitors, antacids or antisecretory agents, phenothiazines or A Constipation, local burning sensation following insertion of suppositories, headache, other neuroleptics, dopaminergic agonists. flushing, IV inj. site reactions. A Raised serum prolactin. S Nausea and vomiting associated with cytostatic drugs and radiotherapy. Diagnostic procedures, eg barium meals and duodenal intubation. P 20mg 3-4 times daily 15-30 mins. before meals and before retiring. Q Under 1 year, under specialist supervision.
Meniereâ&#x20AC;&#x2122;s syndrome. P Initially 16mg three times daily; maintenance, 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Bronchial asthma. Peptic ulcer. C Contra: Antihistamines. A Gastric upset, headache.
STELAZINE
Goldshield
2MO Phenothiazine group III. Trifluoperazine (HCl) 1mg, 5mg. Blue sug-ctd tabs. marked SKF 1mg-112, A2.75; 5mg-112, A3.92. D Comatose states, bone marrow depression, liver damage, existing blood dyscrasis. Uncontrolled cardiac decompensation. B Elderly. CVD. Parkinsonism. Pregnancy, lactation. Epilepsy. A See SPC.
STEMETIL
sanofi-aventis
2MO Phenothiazine. Prochlorperazine maleate 5mg. White tab. marked with tab. name and strength. 5mg-250, A11.09. S Vertigo due to Meniereâ&#x20AC;&#x2122;s disease and other labyrinthine disorders, severe nausea and vomiting. Migraine. P Vertigo, 5mg three times daily. Max. 30mg daily. Nausea and vomiting, 20mg then 10mg two hours later if required. Q Under 10kg, not recommended. Over 10kg, 0.25mg/kg two or three times daily.
2NO
ALSO STEMETIL INJECTION Prochlorperazine mesylate 12.5mg/ml; Amps. 10 x 1ml, A4.03; 10 x 2ml, A5.08. Rowex P 12.5mg by deep IM inj. ONDANSETRON (INN) Teva ROWEX DOMERID Q Not recommended. 2Y 2NO D Comatose states, bone marrow Dopamine antagonist. Domperidone (maleate) Selective 5HT3 receptor-antagonist. Ondansetron depression. Liver damage. 12.72mg equiv. 10mg of domperidone. White, (as hydrochloride dihydrate) 4mg, 8mg. Yellow, B Undiagnosed and prolonged vomiting. round, biconvex tab. marked Dm10. 10, A2.87; 20, Warn patients of impaired dexterity. CVD. oblong film ctd tabs marked with 4 and 8 resp. A4.62. 8mg scored on reverse, not to be broken for half Pregnancy. S Nausea and vomiting, epigastric sense dose admin. 4mg-30, A126.16; 8mg-10, A55.60; C CNS depressants, alcohol, analgesics, of fullness, upper abdominal discomfort, 8mg-50, A277.00. antihypertensives, antidepressants, antidiabetics. regurgitation of gastric contents. 2NO A CNS disturbances. Anticholinergic P 1-2 three to four times daily before effects. ECG and endocrine changes, allergic ALSO ONDANSETRON AMPOULES Ondansetron meal. Max. daily dose: 80mg. Initial duration: 4 effects and extrapyramidal symptoms occur rarely (HCl dihydrate) 2mg per ml. Soln for inj. 2ml, weeks. Severe renal insufficiency (prolonged A58.70; 4ml, A83.84. at low doses. therapy), reduce dose to once or twice daily. 2NO STUGERON McNeil Healthcare Q Over 12 years and weighing 35kg or ALSO ONDANSETRON TABLETS (INN) more, as for adults. Less than 35kg, unsuitable. 2MO Ondansetron (HCl dihydrate) 4mg, 8mg. Film-ctd D Prolactin-releasing pituitary tumour oval tab. marked O on one side and 4 or 8 on the Selective calcium entry blocker. Cinnarizine 25mg. other. 4mg-30, A140.12; 8mg-10, A69.49; 8mg-30, (prolactinoma). GI haemorrhage, mechanical White scored tab. marked JANSSEN one side, S/25 obstruction or perforation. A208.42. on reverse. 50, A4.11. B Lactose intolerance, galactosaemia or S Vertigo of vestibular or cerebrovascular glucose/galactose malabsorption (unsuitable). ONDRAN Pinewood origin. Pregnancy. Lactation, hepatic impairment (not P 1 three times daily. 2NO recommended). Q Not recommended. Selective 5HT3 receptor-antagonist. Ondansetron C CYP3A4 inhibitors. 2 K (HCl dihydrate) 2mg/ml. Soln for inj. and inf. 2ml-5 A Increase in prolactin levels. ALSO STUGERON 15MG Cinnarizine 15mg. White amp., A57.55; 4ml-5 amp., A82.74. scored tab. marked JANSSEN one side S/15 on 2NO SERC Solvay reverse. 15, A2.61. ALSO ONDRAN TABLETS Ondansetron (HCl 2 M O S Motion sickness. dihydrate) 4mg, 8mg. Film-ctd yellow, round P 2 two hours before, then 1 eight hourly Histamine analogue. Betahistine (diHCl) 8mg. biconvex tab.; marked 41, 42 resp. 4mg-10, during journey. White tab. marked with symbol and 256. 120, A45.30; 8mg-10, A69.45. A Q Under 5 years, not recommended; 5-12 5.83. S Management of nausea and vomiting years, half adult dose. 2 M O induced by cytotoxic chemotherapy and D See SPC. ALSO SERC-16 Betahistine (diHCl) 16mg. White radiotherapy. Prevention and treatment of posttab. marked 267 and symbol on reverse. 84 (Cal/ operative nausea and vomiting (PONV). VALOID Amdipharm Pk), A8.15. P Emetogenic chemo/radiotherapy: IV or orally (8mg twice daily for up to 5 days). Highly S Vertigo, tinnitus and hearing loss due to 2 M O
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
EPILEPSY,
Antihistamine. Cyclizine (HCl) 50mg. White, biconvex branded scored tabs. coded T4A. 100, A4.39. S Prevention and treatment of nausea and vomiting due to motion sickness, narcotic analgesics, radiotherapy, Meniere’s disease and other forms of vestibular disturbance. P 50mg orally, up to 3 times a day. Q 6-12 years, 25mg orally up to 3 times a day. Under 6 years, not recommended. Over 12 years, as per adults.
2MO ALSO VALOID INJECTION Cyclizine (lactate) 50mg. Ampoules containing 1ml soln. for inj. 5, A10.14. S Prevention and treatment of nausea and vomiting due to narcotic analgesics, general anaesthetics, radiotherapy, Meniere’s disease and other forms of vestibular disturbance, motion sickness when oral route cannot be used. P 50mg by IM or IV inj. up to 3 times a day. Post-operative vomiting: First dose by slow IV 20 min. before end of surgery. Regurgitation during emergency surgery: 25mg by IV before anesthesia. Q Not indicated. D Pregnancy, lactation (limited data). B Glaucoma, obstructive disease of GI tract, prostatic hypertrophy, severe HF. Driving or operating machines. Abrupt withdrawal. C Additive effects with alcohol, barbiturates, other CNS depressants. Pethidine. Other anticholinergics (enhance side-effects). A Urticaria, drug rash, drowsiness, dry mouth, nose and throat, blurred vision, tachycardia, urinary retention, constipation, restlessness, nervousness, insomnia, auditory/ visual hallucinations, cholestatic jaundice.
VERTIGON
Gerard
2MO Histamine analogue. Betahistine (diHCl) 8mg white tab. marked BH 8 one side, G on reverse; 16mg white tab. marked BH 16 and 256. 8mg-120, A9.70; 16mg-84, A13.57. S Vertigo, tinnitus and hearing loss due to Meniere’s syndrome. P Initially 8-16mg three times daily; maintenance, 24-48mg daily. Q Not recommended. D Phaeochromocytoma. B Bronchial asthma. Peptic ulcer. A Gastric upset.
ZOFRAN
GSK
2NO 5HT3 antagonist. Ondansetron (hydrochlor. dihydrate) 4mg, 8mg. Yellow, biconvex, oval filmctd tabs. marked Glaxo on one side and 4 or 8 on the other. 4mg-30, A84.10; 8mg-10, A41.69; 8mg30, A125.06. S Management of nausea and vomiting due to cytotoxic chemotherapy and radiotherapy. Prevention of post-operative nausea and vomiting.
R Chemotherapy: No dose adjustment. Post-operative nausea and vomiting: Limited experience. Q Chemotherapy: Single IV dose immediately before chemotherapy. Then 4mg orally after 12 hours. Post-operative nausea and vomiting: IV route.
2N ALSO ZOFRAN INJECTION Ondansetron (HCl dihydrate) 2mg/ml. Clear glass, one point cut (OPC) or snap ring amp. 4mg-5; 8mg-5. Price available on request.
2NO ALSO ZOFRAN SUPPS Ondansetron 16mg. 16mg1, A19.45.
2NO ALSO ZOFRAN SYRUP Ondansetron (HCl) 4mg/ 5ml. Sugar-free soln. 50m, A53.24. S V See SPC. B Pregnancy, lactation. Subacute intestinal obstruction (monitor). Zydis contains aspartame, caution in phenylketonuria patients. C CYP3A4 inducers (phenytoin, carbamazepine, rifampicin), reduced blood levels of ondansetron. Analgesic effect of tramadol may be reduced. A Constipation. Headache, flushing, hiccups.
SEIZURES
3.6
doses; maintenance, usually 4-8mg/kg daily. Max. 300mg daily.
2MO ALSO EPANUTIN SUSPENSION Phenytoin 30mg/ 5ml. Oral susp. 500ml, A7.32. P Initially 15ml three times daily. Q Under 6 years, 5ml twice daily, increasing to 5ml three or four times daily; 6-12 years, same as adult.
2MO ALSO EPANUTIN INFATABS Phenytoin 50mg. Yellow scored triangular chewable tab. 100, A6.37; 112, A12.13. P 2 two to four times daily. Q Under 6 years, v tab.; 7-12 years, 1 tab. Both two to four times daily.
2NO
ALSO EPANUTIN PARENTERAL Phenytoin Na+ 50mg/ml. 5ml amp. 1, A5.69; 10, A56.82. S Status epilepticus; prophylaxis and treatment of seizures in neurosurgery. P 150-250mg by slow IV inj., then 100150mg after 30 mins. if required. See SPC. Q In proportion to dosage for 70kg adult. B Porphyria, impaired liver function. Withdraw gradually. 1st sign of acute toxicity, determine serum drug level. Discontinue if skin rash appears (only resume if mild and it has cleared). Not effective for absence (petit mal) seizures. Hyperglycaemia has been reported. May 3.6 EPILEPSY, SEIZURES interfere with Vitamin D metabolism. Measure serum folate at least once every 6 months. DIAMOX Goldshield Contains galactose. Pregnancy, lactation. 5MO C Certain anticonvulsants, antidepressants, anticoagulants, Ca++ channel blockers, antifungals. Carbonic anhydrase inhibitor. Acetazolamide Amiodarone, chloramphenicol, chlordiazepoxide, 250mg. White scored tab. marked LEDERLE 4395. A diazepam, disulfiram, oestrogens, H2-antagonists, 112, 15.56. halothane, isoniazid, methylphenidate, 5NO omeprazole, phenylbutazone, salicylates, folic acid, ALSO DIAMOX PARENTERAL Acetazolamide Na+ rifampicin, sucralfate, theophylline, vigabatrin, St 500mg. Powder in vial. 1, A20.40. John’s wort, antineoplastics, certain antacids, S Epilepsy in conjunction with other ciprofloxacin, alcohol, phenothiazines. See SPC. anticonvulsants. A CNS disorders, inj. site reactions, rash, P 250-1000mg daily in divided doses. haemopoietic complications, GI disorders, Q 125-750mg daily in divided doses; hypersensitivity, polyarthropathy, interstitial infants, 125mg in divided doses. nephritis, pneumonitis. D Chronic closed angle glaucoma. Renal hyperchloraemic acidosis. Adrenal insufficiency. EPILIM sanofi-aventis Na+ or K+ depletion. B Gout. Diabetes. Pregnancy. K+suppl. may 2 M O be required. Monitor fluid, electrolytes and blood. Carboxylic acid deriv. Sodium valproate 200mg, 500mg. Lilac ent-ctd tabs. 200mg-100, A7.65; C Folic acid antagonists, hypoglycaemics, 500mg-100, A19.07. oral anticoagulants. 2MO A Flushing, thirst, headache, drowsiness, polyuria, paraesthesia, blood dyscrasias, ALSO EPILIM CRUSHABLE Sodium valproate excitement, rash. 100mg. White circular scored tab. 100, A4.62.
EPANUTIN
2MO Parke-Davis ALSO EIPLIM SYRUP Sodium valproate 200mg/5ml.
2MO
Hydantoin. Phenytoin Na+ 25mg, 50mg, 100mg, 300mg. White/purple cap., white/pink cap., white/ orange cap. and white/green cap. resp. All marked with cap. name and strength. 25mg-28, A1.10; 25mg-500, A11.39; 50mg-28, A1.11; 50mg-500, 2NO A11.63; 100mg-84, A6.95; 100mg-500, A15.17; 300mg-28, A6.95; 300mg-100, A10.00. ALSO ZOFRAN ZYDIS Ondansetron 4mg, 8mg. Oral lyophilisate. White round tab. 4mg-10, S Tonic-clonic seizures, partial seizures. A50.73; 8mg-10, A101.45. Prevention and treatment of seizures following P Emetogenic chemo/radiotherapy: 8mg 1- neurosurgery or head injury. Trigeminal neuralgia (2nd line). 2 hours before treatment. Then 8mg orally after 12 hours. Highly emetogenic chemotherapy: 24mg P Initially 3-4mg/kg daily increasing orally, (taken with 12mg oral dexamethasone), 1-2 gradually until control; maintenance, usually 200500mg daily in single or divided doses. hours before treatment. Post-operative nausea Q Neonates, titrate according to serum and vomiting prevention: 16mg orally, 1 hour levels. Others, initially 5mg/kg daily in two divided prior to anaesthesia. Treatment, use IV route.
Clear, cherry red syrup. 300ml, A7.00.
2MO ALSO EPILIM LIQUID Sodium valproate 200mg/ 5ml. Sugar-free. 300ml, A7.00.
2MO ALSO EPILIM CHRONO Sodium valproate (as valproate and valproic acid) 200mg, 300mg, 500mg. Violet oblong, film-ctd prolonged release tab. 200mg-100, A8.25; 300mg-100, A12.38; 500mg-100, A20.64.
2MO ALSO EPILIM CHRONOSPHERE Sodium valproate (as valproate and valproic acid) 100mg, 250mg, 500mg, 750mg, 1000mg. Prolong. release granules in sachets. 100mg-30, A9.79; 250mg-30, A10.02; 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, A18.72.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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3.6 EPILEPSY,
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S Generalised, partial or other epilepsy. P Initially 600mg daily increasing by 200mg at three day intervals or for Chronosphere initially 10-15mg/kg/day increasing at 2-3 day intervals. Usual maintenance, 1-2g daily (20-30mg/ kg/day). Max. 2.5g daily. Epilim Chrono and Chronosphere may be given once or twice daily. Q Under 20kg, initially 20mg/kg/day. Over 20kg, initially 400mg daily. Max. 40mg/kg daily. Chronosphere, see adults. Usual maintenance, 2030mg/kg/day. See SPC. Epilim Chrono not suitable for children under 20kg.
Q Under 3 years, not recommended; 3-12 years, up to half adult dose. D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic insufficiency, drug or alcohol dependence. Pregnancy, lactation (use only if essential). Children (6 months-3 years) other than in exceptional cases. B Tolerance, dependence, anterograde amnesia, psychiatric and paradoxical reactions may occur. Caution: Pre-existing muscle weakness, spinal/cerebellar ataxia. Elderly, acute respiratory insufficiency, renal/hepatic impairment; reduce dose. Driving/operating machinery. C Not recommended: Alcohol. Caution: CNS depressants. A Drowsiness, reduced alertness, numbed emotions, confusion, fatigue, headache, dizziness, muscle weakness, fine tremor, double vision.
GABA analogue. Gabapentin 100mg, 300mg, 400mg. Hard gelatine caps. with white (100mg), yellow (300mg) or orange (400mg) opaque body. 100mg-100, A16.92; 300mg-100, A39.20; 400mg100, A45.36. S Partial seizures with and without secondary generalisation as adjunctive therapy (r6 years) or as monotherapy (r12 years). P 12 years and over, 900-3600mg/day swallowed whole with water. Titrate 300mg once daily (Day 1), twice daily (Day 2) and three times daily (Day 3); alternatively 300mg three times daily on Day 1. Can then be increased in 300mg/day 2N increments every 2-3 days up to max. 3600mg/day. ALSO EPILIM INTRAVENOUS Sodium valproate Admin. in three divided doses with max. 12 hrs A 400mg. Powder in vial plus 4ml WFI. 1, 12.19. between each dose. Discontinue gradually over S Generalised, partial or other epilepsy, min. 1 week. Renal impairment: See SPC. where oral treatment is not possible. Q 6 years and over: Initially, 10-15mg/kg/ P Initially 400-800mg IV inf., followed by day; titrate over approx. 3 days to 25-35mg/kg/ continuous inf. of up to 10mg/kg/day. Max. 2.5g day. Admin. in three divided doses with max. 12 daily. GABAPENTIN TEVA Teva hrs between each dose. Q Usually 20-30mg/kg/day IV inf. Max D Pregnancy, lactation (unless benefit 40mg/kg/day but only if valproic acid levels 2MO outweighs risk). monitored. GABA analogue. Gabapentin 600mg, 800mg. B Acute pancreatitis (discontinue). Mixed D Active liver disease, personal or family White to off-white, oval shaped, bevelled edged, seizures including absences (caution). Long-term history of severe hepatic dysfunction (esp. drug film-ctd tab. engraved 7173 (600mg) or 7174 therapy (q 36 weeks) in children and adolescents related), porphyria. (800mg) on 1 side and 93 the other. 600mg-100, (no data). False positive in dipstick tests (total B Risk of severe liver damage (incl. A83.64; 800mg-100, A101.66. urine protein). Driving/operating machines. hepatic failure); increased risk in children Q 3 S Adjunctive therapy in treatment of Contains lactose. years. Liver function tests advised before therapy partial seizures with and without secondary C Morphine (caution). Take min. 2 hrs and in first 6 months, especially when risk or generalisation in adults and children r 6 years . after antacid. history of liver disease. Pancreatitis may occur, esp. As monotherapy in treatment of partial seizures A CNS effects eg. somnolence, dizziness, in young children (prompt medical evaluation in with and without secondary generalisation in ataxia. Infections eg. viral, RTI, UTI. Psychiatric patients with acute abdominal pain). adults and adolescents r 12 years. Monotherapy recommended in children Q 3 years P Effective dose, 900-3600mg/day. Initiate disorders eg. hostility, confusion, emotional lability. Fatigue, fever, oedema, abnormal gait, at risk of liver toxicity and pancreatitis. Blood cell by dose titration: 300mg once daily on day 1, pain, flu syndrome, arthralgia, myalgia, purpura, count, bleeding time and coagulation tests advised increasing to 300mg twice daily on day 2, then rash, vertigo. Hypertension, vasodilatation, visual before therapy. Monitor for suicidal thoughts/ 300mg three times daily on day 3. Alternatively behaviour. Caution: Systemic lupus erythematosus. initiate with 300mg 3 times/day on day 1. disturbances. Respiratory/GI disorders. Pregnancy (careful evaluation benefit/risk). Warn Incontinence, impotence. WBC decreased, Thereafter, can be increased in 300mg/day patients about risk of weight gain. May cause increments every 2-3 days up to 3600mg/day max. leucopenia, weight gain, appetite change. false positives in urine tests for diabetes. Accidental injury. Aggressive behaviour and Renal impairment, haemodialysis: See SPC. Hyperammonaemia: Metabolic tests advised before R Adjust according to renal function. hyperkinesias in children. therapy in those at risk. Withdraw carefully. Q q12 years, as per adults. r 6 years: C Avoid salicylates in children Q 3 years. GABITRIL Cephalon Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ Caution: Antipsychotics, MAOIs, antidepressants, kg/day reached by upward titration over a approx. 2 M O benzodiazepines, phenobarbital, primidone, Selective inhibitor of GABA uptake. Tiagabine 3 days. Doses up to 50mg/kg/day well tolerated. phenytoin, carbamazepine, lamotrigine, 5mg, 10mg, 15mg. White film-ctd scored tabs Divide total daily dose in 3 single doses with 12 zidovudine, vit K-dependent anticoagulants, marked 251, 252 or 253. 5mg-100, A72.26;10mghour interval (max) between doses. felbamate, mefloquine, chloroquine, highly 100, A104.16; 15mg-100, A156.24. D Pregnancy, lactation (unless benefit protein Avoid salicylates in children Q 3 years. S Add-on therapy for partial seizures with outweighs risk). Caution: Antipsychotics, MAOIs, antidepressants, or without secondary generalisation not controlled B Consider discontinuation if acute benzodiazepines, phenobarbital, primidone, with other AEDs. pancreatitis develops. Caution in patients with phenytoin, carbamazepine, lamotrigine, P Initially 7.5-15mg/day in three divided mixed seizures incl. absences. Assess risks/benefits zidovudine, vit K-dependent anticoagulants, of prolonged therapy in children and adolescents. doses increasing with weekly increments of 5felbamate, mefloquine, chloroquine, highly 15mg/day. Usual maintenance, 30-50mg/day; max. Monitor for signs of suicidal ideation and protein bound agents (eg. aspirin), cimetidine, 70mg/day. behaviours. False positive in dipstick tests (total erythromycin, carbapenem antibiotics, Q Not recommended. urine protein). Withdraw gradually. Pregnancy, colestyramine, rifampicin, newer anti-epileptics D Severely impaired liver function. lactation. Driving/operating machinery. (e.g. topiramate). Generalised epilepsy, particularly idiopathic forms C Morphine, antacids. A Congenital disorders, transient GI with absences. A IInfections (e.g. viral, UTI, RTI, otitis disorders, increased alertness, aggression, B Withdraw gradually; patients with a media, pneumonia), leucopenia, anorexia, hyperactivity, behavioural deterioration, confusion, increased appetite, psychiatric and nervous system history of serious behavioural problems; perforrm thrombocytopenia, transient hair loss, full blood count if ecchymoses are observed. disorders, visual disturbances, vertigo, amenorrhoea, dysmenorrhoea, allergic reactions, hypertension, vasodilatation, dyspnoea, bronchitis, Pregnancy, lactation. increased weight. A Dizziness, tiredness, somnolence. pharyngitis, cough, rhinitis, GI disorders, facial FRISIUM sanofi-aventis oedema, purpura, rash, pruritus, acne, arthralgia, GERICARB SR Gerard myalgia, back pain, twitching, incontinence, 2NO impotence, fatigue, fever, peripheral or 2MO Benzodiazepine. Clobazam 10mg. White tab. generalized oedema, abnormal gait, asthenia, Dibenzazepine. Carbamazepine 200mg, 400mg. marked Hoechst one side, scored and coded B/GL pain, malaise, flu syndrome, decreased WBC, White to yellowish, round, flat, cloverleaf shaped on reverse. 100, A9.44. weight gain. prolonged release tabs with bevelled edge, S Adjunct in epilepsy. double-sided cross break-mark, 4 notches on band. P 10-20mg daily with increases of 10mg GABIN Rowex Can be divided into equal halves. 200mg-56 increments. Max. 60mg daily. Reassess after 4 2MO A4.48; 400mg-56, A8.85. weeks.
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Restricted b2 agonists
Declaration required
CNS S Epilepsy. Generalised tonic-clonic. Partial seizures. P Initially 100-200mg once or twice daily increasing slowly to 400-600mg morning and night. Max daily dose of 1600-2000mg may be required. Q Not suitable under 5 years. 5-10 years: Initially 200mg at night (or 100mg morning and night). Maintenance: 100-200mg morning and 200400mg at night. 10-15 years: Initially 200mg at night (or 100mg morning and night); maintenance: 100-400mg morning and 400-600mg at night. D Bone marrow depression, AV conduction abnormalities, acute intermittent porphyria. B Evaluate benefit/risk: Haematological disturbances, disturbed Na+ metabolism, severe cardiac, liver and kidney dysfunction, myotonic dystrophia, pregnancy, lactation. Patients should consult immediately if fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, skin yellowing and liver enlargement occurs. Caution: Severe cardiovascular disease, liver disease or renal damage, elderly, glaucoma (regulary check IOP), high doses. May trigger or exacerbate absences. Increase in seizure frequency or the onset of new types of seizures may occur. Test blood regularly; discontinue if severe leucopenia or thrombocytopenia appear. Perform liver function tests periodically. Discontinue if severe dermatological reactions, severe hypersensitivity occur. Avoid sunlight exposure. Driving/operating machines. C Not recommended: MAOIs. Caution: Anticonvulsants, CYP450 inducers/inhibitors, digoxin, theophylline, cisplatin, doxorubicin, clonazepam, St. John’s Wort, azole antimycotics, macrolide antibiotics, isoniazid, Ca++ antagonists, acetazolamide, dextropropoxyphene, propoxyphene, viloxazine, danazol, nicotinamide (at high dose in adults), nefazodone, fluvoxamine, terfenadine, loratadine, grapefruit juice, protease inhibitors, cimetidine (doses r 800mg), desipramine, phenobarbital, lamotrigine, primidone, clobazam, ethosuximide, tiagabine, alprazolam, corticosteroids, doxycycline, dihydropyridines, haloperidol, other neuroleptic drugs, TCAs, trazodone, topiramate, methadone, tramadol, anticoagulants, bromperidol, olanzapine, quetiapine, praziquantel, caspofungin, fentanyl, midazolam, phenazone, propranolol, methylphenidate, flunarizine, quinidine and hydroquinidine, tacrolimus, sirolimus, cyclosporine, oral contraceptives, HRT, bupropion, psychotropic drugs, paracetamol, lithium, hypokalaemic diuretics (loop and thiazide diuretics), antiarrhythmics, muscle relaxants, isotretinoin, thyroid hormones, serotonin re-uptake inhibitors, clozapine, procarbazine, alcohol. A Blood dyscrasias, dizziness, somnolence, sedation, drowsiness, ataxia, elevated gamma-GT, fatigue.
EPILEPSY, two days. Max. depends on body weight: 1800mg/ day (30-50kg), 2400mg/day (50.1-70kg), 3200mg/ day (r70.1kg). Withdraw gradually (approx. 25% every two days). Q Under 4 years, not recommended. 4 years and older: r 30kg, as per adults. Q30kg: Initially 200mg; may be increased by 200mg/day increments every two days. Max: 1000mg/day or 400mg/day if admin. in combination with valproate. D Severe hepatic impairment. Pregnancy (unless clearly necessary), lactation. B Mild to moderate hepatic impairment. Status epilepticus cases, antiepileptic drug hypersensitivity syndrome (discontinue if suspected). Accidental falls. Women should use contraceptive measures. Driving/using machines. Contains lactose. C Caution: Some AEDs (carbamazepine, phenobarbital, phenytoin, vigabatrin or primidone, valproate), hormonal contraceptives, CYP3A substrates, warfarin, digoxin. A Somnolence, headache, dizziness, nausea, vomiting, fatigue. Pneumonia, flu, upper respiratory/ear infections, eating disorder, decreased appetite and weight, anxiety, insomnia, status epilepticus, convulsion, coordination abnormal, nystagmus, psychomotor hyperactivity, tremor, vision disorders, vertigo, epistaxis, GI disorders, hepatic enzyme increase, rash, acne, back pain, oligomenorrhoea, gait disturbance, head injury, contusion.
SEIZURES
3.6
twice daily every 2 weeks depending upon response. Max. 1500mg twice daily. Adjunctive therapy: As IV inf. over 15 min; dose as per Keppra Oral Soln. Renal impairment, see SPC. Q As IV inf; dose as per Keppra Oral Soln. D Pregnancy (unless clearly necessary), lactation. B Severe hepatic impairment, driving or operating machines. Withdraw gradually. Soln. contains glycerol. Concentrate contains sodium. C Caution: Probenecid, NSAIDs, sulfonamides, methotrexate. A Asthenia, somnolence, amnesia, ataxia, convulsion, dizziness, headache, tremor, depression, emotional lability, hostility, insomnia, nervousness, diarrhoea, dyspepsia, nausea, anorexia, weight increase, vertigo, diplopia, accidental injury, myalgia, infection, nasopharyngitis, cough increased, rash, thrombocytopenia.
LAMICTAL
GSK
2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Pale yellow, multi-faceted, superelliptical tabs. marked with strength and code on reverse. 25mg56, A25.21; 50mg-56, A39.57; 100mg-56, A68.26; 200mg-56, A122.88.
2MO
ALSO LAMICTAL DISPERSIBLE Lamotrigine 2mg, 5mg, 25mg, 50mg, 100mg, 200mg. White tabs. marked with strength and code on reverse. 2mg30, A6.49; 5mg-28, A8.95; 25mg-56, A25.21; KEPPRA UCB 50mg-56, A39.38; 100mg-56, A68.26; 200mg-56, A123.91. 2NO S r 13 years: Adjunctive or monotherapy Pyrrolidone derivative. Levetiracetam 250mg, treatment of partial seizures and generalised 500mg, 1000mg. Blue, yellow and white scored tabs. marked ucb 250, ucb 500 and ucb 1000 resp. seizures, incl. tonic-clonic seizures. Seizures All oblong film-ctd. 250mg-60, A39.44; 500mg-60, associated with Lennox-Gastaut syndrome (as adjunctive therapy; may also be given as initial A69.18; 1000mg-60, A134.93. antiepileptic drug). Children aged 2 to 12 years: 2NO Adjunctive treatment of partial seizures and ALSO KEPPRA ORAL SOLUTION Levetiracetam generalised seizures, incl. tonic-clonic seizures and A 100mg/ml. 300ml, 96.35. seizures associated with Lennox-Gastaut syndrome. S Partial onset seizures with or without Monotherapy of typical absence seizures. secondary generalisation as monotherapy (r16 P Monotherapy: Initially 25mg once daily years) in newly diagnosed epilepsy or as for 2 weeks, followed by 50mg once daily for 2 adjunctive therapy (r4 years); myoclonic seizure weeks; thereafter usual maintenance, 100-200mg (r12 years) in Juvenile Myoclonic Epilepsy; daily, once daily or in 2 divided doses; max. primary generalised tonic-clonic seizures (r12 500mg daily. Adjunctive therapy: With valproate: years) in Idiopathic Generalised Epilepsy. Initially 12.5mg/day (or 25mg on alternate days) P Monotherapy (q16 years): Initially, for 2 weeks, followed by 25mg once daily for 2 250mg twice daily increased to 500mg twice daily weeks; maintenance 100-200mg once daily or in 2 after 2 weeks; can be further increased by 250mg divided doses. With enzyme inducers (except twice daily every 2 weeks up to 1500mg twice valproate): Initially 50mg once daily for 2 weeks, daily. Adjunctive therapy: Initially, 500mg twice followed by 100mg daily in 2 divided doses for 2 daily; can be increased up to 1500mg twice daily weeks; thereafter usual maintenance dose 200in increments of 500mg twice daily every 2-4 400mg daily in 2 divided doses; max. 700mg daily. weeks. Renal impairment, see SPC. Without valproate or enzyme inducers: Initially Q 4-17 years and Q 50kg: Initially 10mg/ 25mg once daily for 2 weeks, followed by 50mg kg twice daily; can be increased up to 30mg/kg daily in 2 divided doses for 2 weeks; thereafter twice daily in increments of max. 10mg/kg twice usual maintenance dose 100-200mg daily in 2 daily every 2 weeks. 50kg or more, as per adults. divided doses. See SPC for dose escalation in all Under 4 years, not recommended. cases. INOVELON Eisai 2 N O Q Under 2 years, not recommended. 2-12 2MO ALSO KEPPRA CONCENTRATE Levetiracetam years: Monotherapy: Initially 0.3 mg/kg/day (once 100mg/ml. Soln for inf. 10-100mg/ml, A190.98. Carboxamide derivative. Rufinamide 100mg, a day or two divided doses) for 2 weeks; followed 200mg, 400mg. Pink, ovaloid, slightly convex, film- S Monotherapy in partial onset seizures by 0.6 mg/kg/day (once a day or two divided ctd tabs. scored on both sides, marked A261, with or without secondary generalisation (r 16 doses) for 2 weeks; thereafter usual maintenance A262, A263 resp. 100mg-10, A6.39; 200mg-60, years) in newly diagnosed epilepsy. Adjunctive 1-10 mg/kg/day (once a day or two divided doses), A61.94; 400mg-60, A121.55. therapy when oral admin. is temporarily not higher doses up to 15 mg/kg/day may be required. feasible. S Adjunctive therapy in treatment of Adjunctive therapy: With valproate: Initially 0.15 seizures associated with Lennox-Gastaut syndrome. P Monotherapy: Initially 250mg IV inf. mg/kg/day (once a day) for 2 weeks; followed by twice daily, should increase to 500mg twice daily P Initially 400mg preferably with food; 0.3 mg/kg/day (once a day); thereafter usual after 2 weeks. Can be further increased by 250mg maintenance 1-5 mg/kg/day (once a day or two may be increased by 400mg/day increments every AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
117
3.6 EPILEPSY,
CNS
SEIZURES
divided doses); maximum 200mg/day. With enzyme inducers (except valproate): Initially 0.6 mg/kg/day (2 divided doses) for 2 weeks; followed by 1.2 mg/kg/day (2 divided doses) for 2 weeks; thereafter usual maintenance 5-15 mg/kg/day (once a day or 2 divided doses). Without valproate or enzyme inducers: Initially 0.3 mg/kg/day (once a day or 2 divided doses) for 2 weeks; followed by 0.6 mg/kg/day (once a day or 2 divided doses); thereafter usual maintenance 1-10 mg/kg/day (once a day or 2 divided doses). See SPC for dose escalation in all cases. B Renal failure (caution). Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hypersensitivity syndrome. Withdraw gradually. Monitor for suicidality (increased risk below 18 years). Myoclonic seizures may worsen. Pregnancy, lactation. Driving/operating machinery. Contains lactose. C Valproate reduces dose requirement. May increase dose requirement: Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination (consider continuous hormonal contraceptives or non-hormonal contraceptives to LAMOTRIGINE RANBAXY Ranbaxy limit variations in lamotrigine levels). A Aggression, irritability, headache, 2MO LAMORO Pinewood Lamotrigine 25mg, 50mg, 100mg, 200mg. White somnolence, dizziness, tremor, insomnia, ataxia, nystagmus, tremor, diplopia, blurred vision, GI 2MO to off-white round tab., debossed with L12, L13, disorders, tiredness. Triazine Lamotrigine 25mg, 50mg, 100mg, 200mg. L14 or L15 (resp.) on one side. 25mg-56, A13.44; A A Dispersible white to off-white round tabs. 25mg50mg-56, 21.10 ; 100mg-56, 36.40; 200mg-56, LARIG Rowex 60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; A66.51. 2MO 200mg-60, A96.11. S Adults and adolescents q 13 years: As adjunctive or monotherapy treatment of partial S Epilepsy, partial and generalised Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. seizures incl. tonic-clonic seizures and the seizures seizures and generalised seizures, incl. tonic-clonic White, square dispersible tab. marked L and seizures; seizures associated with Lennox-Gastaut associated with Lennox Gastaut Syndrome. strength. 25mg-56, A19.57; 50mg-56, A30.56; P Monotherapy: Initially 25mg once daily syndrome; as adjunctive therapy in Lennox-Gastaut 100mg-56, A52.97; 200mg-56, A96.15. syndrome (may also be the initial antiepileptic for 2 weeks, followed by 50mg once daily for 2 S As adjunctive or monotherapy in the drug). Children and adolescents aged 2-12 years: weeks; thereafter usual maintenance, 100-200mg treatment of epilepsy, for partial seizures and Adjunctive treatment of partial seizures and daily, once daily or in 2 divided doses; max. generalised seizures, incl. tonic-clonic seizures and generalised seizures, incl. tonic-clonic seizures and the seizures associated with Lennox-Gastaut 500mg daily. Add on therapy: Patients taking seizures associated with Lennox-Gastaut syndrome; Syndrome. valproate: Initially 25mg on alternate days for 2 monotherapy of typical absence seizures. weeks, followed by 25mg once daily for 2 weeks; P Monotherapy: Initially 25mg once daily maintenance 100-200mg once daily or in 2 divided P Monotherapy: Initially 25mg once daily for 2 weeks; usual maintenance, 100-200mg once for 2 weeks, followed by 50mg once daily for 2 doses. Patients not taking valproate but taking daily or in 2 divided doses; max. 500mg daily. Add weeks; thereafter usual maintenance, 100-200mg inducers of lamotrigine glucoronidation: Initially on therapy: Initially in those taking enzyme daily, once daily or in 2 divided doses; max. 50mg once daily for 2 weeks, followed by 100mg inducing anti-epileptic drugs (AEDs) and not 500mg daily. Adjunctive therapy with valproate: daily in 2 divided doses for 2 weeks; thereafter taking Na+ valproate: 50mg once daily for 2 Initially 12.5mg/day (or 25mg on alternate days) usual maintenance dose 200-500mg daily in 2 weeks; usual maintenance dose 200-500mg/day in for 2 weeks, followed by 25mg once daily for 2 divided doses; max. 700mg daily. Patients not 2 divided doses; max. 700mg daily. Patients taking weeks; maintenance 100-200mg once daily or in 2 valproate (or AEDs with interaction unknown): taking valproate but taking oxcarbazepine and divided doses. Adjunctive therapy with enzyme without inducers or inhibitors of lamotrigine Initially 25mg on alternate days for 2 weeks; inducers (except valproate): Initially 50mg once glucuronidation: 25mg once daily for 2 weeks, maintenance 100-200mg once daily or in 2 divided daily for 2 weeks, followed by 100mg daily in 2 followed by 50mg once daily for 2 weeks; doses. See SPC for dose escalation in all cases. divided doses for 2 weeks; thereafter usual thereafter usual maintenance dose 100-200mg Hepatic impairment: Moderate, half adult dose; once daily or in 2 divided doses. See SPC for dose maintenance dose 200-400mg daily in 2 divided severe, 1/4 adult dose. escalation in all cases. Special patient populations: doses; max. 700mg daily. Adjunctive therapy Q Under 2 years, not recommended. Over without valproate or enzyme inducers: Initially Refer to SPC. 12 years, as per adults. 2-12 years: Only as add-on 25mg once daily for 2 weeks, followed by 50mg Q Under 2 years, not recommended; 2-12 therapy. Initially in those taking enzyme inducing daily in 2 divided doses for 2 weeks; thereafter years: Patients taking valproate with/without any AEDs and not taking valproate, 0.6mg/kg daily in usual maintenance dose 100-200mg daily in 2 other AED: Initially 0.15mg/kg once daily for 2 2 divided doses for 2 weeks; usual maintenance 5weeks, followed by 0.3mg/kg daily once daily for 2 divided doses. See SPC for dose escalation in all 15mg/kg daily in 2 divided doses; max. 400mg weeks; thereafter increase by max. 0.3mg/kg every cases. daily. In those taking valproate, initially 0.15mg/kg Q Under 2 years, not recommended. 2-12 1-2 weeks until optimal response; usual once daily for 2 weeks; usual maintenance 1-5mg/ years: Monotherapy: Initially 0.3 mg/kg/day (once maintenance 1-5mg/kg once daily or in 2 divided kg once daily or in 2 divided doses; max. 200mg a day or 2 divided doses) for 2 weeks; followed by daily. See SPC for dose escalation in both cases. If doses; max. 200mg daily. Patients not taking 0.6 mg/kg/day (once a day or 2 divided doses) for calculated dose 1-2mg, 2mg may be taken on valproate but taking inducers of lamotrigine 2 weeks; thereafter usual maintenance 1-10 mg/ glucoronidation: Initially 0.6mg/kg daily in 2 alternate days for first 2 weeks. If calculated dose kg/day (once a day or 2 divided doses), higher divided doses for 2 weeks, followed by 1.2mg/kg Q 1mg, do not admin. doses up to 15 mg/kg/day may be required. daily in 2 divided doses for 2 weeks; thereafter B Renal/hepatic impairment. Rare skin Adjunctive therapy: With valproate: Initially 0.15 increase by max. 1.2mg/kg every 1-2 weeks until reactions eg. Stevens Johnson syndrome. Promptly optimum response; usual maintenance 5-15mg/kg mg/kg/day (once a day) for 2 weeks; followed by evaluate patients who develop rash. 0.3 mg/kg/day (once a day); thereafter usual daily given in 2 divided doses; max. 400mg daily. Hypersensitivity syndrome. Pregnancy, lactation maintenance 1-5 mg/kg/day (once a day or 2 Patients taking oxcarbazepine without any (only if benefit outweighs risk). Driving/using
divided doses). With enzyme inducers (except valproate): Initially 0.6 mg/kg/day (two divided doses) for 2 weeks; followed by 1.2 mg/kg/day (two divided doses) for 2 weeks; thereafter usual maintenance 5-15 mg/kg/day (once a day or two divided doses). Without valproate or enzyme inducers: Initially 0.3 mg/kg/day (once a day or two divided doses) for 2 weeks; followed by 0.6 mg/kg/day (once a day or two divided doses); thereafter usual maintenance 1-10 mg/kg/day (once a day or two divided doses). See SPC for dose escalation in all cases. B Renal/hepatic impairment. Rare skin reactions e.g. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Pregnancy, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for suicidal ideation and behaviour. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ ritonavir, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Aggression, irritability, headache, somnolence, dizziness, tremor, insomnia, ataxia, nystagmus, diplopia, blurred vision, GI disorders, skin rash, tiredness.
118
inducers or inhibitors of lamotrigine glucuronidation: Initially 0.3mg/kg once daily or in 2 divided doses for 2 weeks, followed by 0.6mg/kg once daily or in 2 divided doses for 2 weeks; thereafter increase by max. 0.6mg/kg every 1-2 weeks until optimal response; usual maintenance 1-10mg/kg once daily or in 2 divided doses; max. 200mg daily. See SPC for dose escalation in all cases. B Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. Hormonal contraceptives. Hypersensitivity syndrome. Renal/hepatic impairment. Withdraw gradually. Driving/ operating machinery. Pregnancy, lactation. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, ethinyloestradiol/levonorgestrel combination may increase dose requirement. Valproate reduces dose requirement. A Skin rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, nystagmus, ataxia, diplopia, blurred vision, GI disturbance, tiredness, agitation, arthralgia, somnolence, pain, back pain.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS machines. Withdraw gradually. C Enzyme inducing anti-epileptic drugs (AEDs) (eg. phenytoin, primidone, carbamazepine, phenobarbitone) may increase dose requirement. A Rash, irritability, headache, drowsiness, insomnia, dizziness, tremor, vision disorders, GI disorders, tiredness, arthralgia, pain, back pain.
EPILEPSY,
SEIZURES
3.6
barbiturates), St John’s Wort. A Drowsiness, listlessness, ataxia, visual disturbances, nystagmus, nausea; all usually transient.
A Fatigue, ataxia, dizziness, somnolence. See SPC.
NEURONTIN
2NO
2MO
PRO-EPANUTIN
Parke-Davis
Pfizer Hydantoin. Fosphenytoin Na+ 75mg per ml (equiv.
GABA analogue. Gabapentin 100mg white cap.; 300mg yellow cap.; 400mg orange cap.; 600mg white tab.; 800mg white tab. All marked with name and strength. 100mg-100, A24.86; 300mg100, A57.65; 400mg-100, A66.71; 600mg-100, A104.55; 800mg-100, A127.08. LYRICA Pfizer S Partial seizures with and without 2MO secondary generalisation as adjunctive therapy GABA analogue. Pregabalin 25mg, 50mg, 75mg, (r6 years) or as monotherapy (r12 years). 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., P Initially 300mg once daily on day 1, marked Pfizer on cap., and PGN and strength on increasing to 300mg twice daily on day 2, then body. 25mg-56, A81.70; 84, A122.55; 50mg-84, 300mg three times daily on day 3. Thereafter dose A122.55; 75mg-56, A81.70; 100mg-84, A122.55; can be increased using increments of 300mg per 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, day given in three divided doses to a max. of A81.70. 3600mg per day. Effective dose range is 900S Adjunctive therapy in adults with partial 3600mg daily. seizures with or without secondary generalisation. Q Under 6 years, not recommended; 6-12 P Initially, 150mg per day in either two or years, 25-35mg/kg/day given in three divided three divided doses. May be increased to 300mg doses. Initially 10mg/kg/day on day 1, 20mg/kg/day per day after 1 week and to max. 600mg per day on day 2 and 25-35mg/kg/day on day 3. after an additional week. Discontinue gradually B Elderly, haemodialysis, renal impairment over a min. of 1 week. Renal impairment: Adjust (see SPC), mood and behavioural disturbances. dosage (see SPC). Ability to drive or operate machinery may be R Reduce dose in renal dysfunction. affected. Pregnancy, lactation. Discontinuation of Q Under 18 years, not recommended. gabapentin and/or additional or substitution of D Pregnancy (unless essential), lactation. alternative therapy should be gradual over a B Withdrawal symptoms may occur. minimum of 1 week. Not effective in absence Driving/using machines. Contains lactose. seizures. C Caution: Ethanol, lorazepam, C Caution: Morphine, antacids. antidiabetics (adjust dose). A Dizziness, tiredness. Increased appetite, A CNS effects (somnolence, dizziness, weight gain, euphoric mood, confusion, change in ataxia, nystagmus, tremor), fatigue, headache, diplopia, GI disturbances (nausea, vomiting), libido, irritability, attention disturbances, rhinitis, amblyopia. clumsiness, memory impairment, tremor, speech difficulty, paraesthesia, visual disturbances, NEUROSTIL Teva vertigo, dry mouth, GI disorders, erectile dysfunction, peripheral oedema, drunken feeling, 2 M O abnormal gait. GABA analogue. Gabapentin 100mg, 300mg, 400mg. Resp. grey, orange or brown hard cap. MYSOLINE Acorus marked resp. 93 and 38, 93 and 39 or 93 and 40. 100mg-100, A19.89; 300mg-100, A46.12; 400mg2MO 100, A53.37. Pyrimidinedione. Primidone 250mg. White scored S Partial seizures with and without tab. marked MM. 100, A16.00; 1000, A18.79. secondary generalisation as adjunctive therapy S Grand mal and psychomotor (temporal lobe) epilepsy. Also of value in focal or Jacksonian (r3 years) or as monotherapy (r12 years). P Initially 900mg/day. Titrate by 300mg seizures, myoclonic jerks and akinetic attacks. once daily on day 1, 300mg twice daily on day 2, P Initially 125mg at night increasing at 3 300mg three times daily on day 3. Can be day intervals by 125mg to 500mg daily, then increased by 300mg/day increments in 3 equally increase by 250mg to max. 1.5g daily. Usually divided doses, up to 3600mg/day max. Effective twice daily. Q Initially same regimen as adults but use dose range 900-3600mg daily. Max 12 hours between doses. Renal impairement, haemodialysis: 125mg increments. Maintenance: up to 2 years, See SPC. 250-500mg; 2-5 years, 500-750mg; 6-9 years, R Adjust according to renal function. 750mg-1g; 9-12 years, 750mg-1.5g. All as daily Q 3-12 years, initially 10-15mg/kg/day in 3 doses, best divided in 2 equal amounts morning divided doses; titrate over 3 days. r 5 years: 25and evening. 35mg/kg/day in 3 divided doses. 3-5 years: 40mg/ D Porphyria. Pregnancy (only if essential; kg/day in 3 divided doses. Doses up to 50mg/kg/ vit K1 suppl). B Children, elderly, debilitated patients. day well tolerated. Max 12 hours between doses. Impaired renal, hepatic or respiratory function. B Mood and behavioural disturbances Metabolised to phenobarbitone; potential for may occur. Monitor for suicidal ideation. tolerance/ dependance. Withdraw gradually. Vit. D Withdraw gradually over at least 1 week. Not suppl. in long term therapy. Megaloblastic effective in absence seizures. Pregnancy (only use anaemia requiring discontinuation. Lactation if clearly needed), lactation. Driving/using (monitor baby for sedation). machines. C Caution: Other anticonvulsants, C Caution: Morphine, antacids. False coumarin anticoagulants, oral contraceptive positive readings reported with Ames N-Multistix steroids, other CNS depressants (eg. alcohol, SG dipstick test.
to 50mg PE). Clear, colourless to pale yellow soln. in vial. 10 x 10ml, A439.08. S Status epilepticus of tonic-clonic type. Prevention and treatment of seizures connected with neurosurgery or head trauma. Substitute for oral phenytoin where oral admin. is not possible. P Status epilepticus: initially 15mg PE/kg by IV inf. at a rate of 100-150mg PE/min. Maintenance: 4-5mg PE/kg daily by IV inf. or IM inj. Treatment and prophylaxis of seizures: initially 10-15mg PE/kg by IV inf. at a rate of 50-100mg PE/ min. or by IM inj. Maintenance: 4-5mg PE/kg daily by IV inf. or IM inj. Dilute soln before IV inf. Dosage expressed in phenytoin sodium equiv. (mg PE). 1.5mg fosphenytoin sodium 1mg PE. Q Under 5 years, not recommended; over 5 years, same mg PE/kg dose as adult by IV inf. D Sinus bradycardia, SA block, 2nd or 3rd degree AV block, Adams-Stokes syndrome, porphyria. Lactation. B Hypotension, severe myocardial insufficiency, acute cerebrovascular event, renal or hepatic disease, elderly (lower dose may be required), hypoalbuminaemia, phosphate intake restriction, diabetes. Monitor ECG, BP and respiration during and for 30 mins. after IV inf.; cardioresuscitation facilities must be available. Withdraw gradually. Discontinue if rash, hypersensitivity or signs of hepatotoxicity or lymphadenopathy occur. Pregnancy. C Amiodarone, antifungals, antineoplastics, benzodiazepines, corticosteroids, coumarin anticoagulants, frusemide, oral contraceptives, quinidine, vit. D, folic acid, theophylline, disulfiram, anticonvulsants, ulcer healing drugs, analgesics, antacids, antipsychotics, antidepressants, tolbutamide. A Cardiovascular complications, CNS effects, blood dyscrasias, hepatitis, liver damage, intestinal nephritis, GI upset, pruritus, headache, hirsutism, hypersensitivity reactions.
RANGABAX
Ranbaxy
2MO GABA analogue Gabapentin 100mg, 300mg, 400mg, 800mg. 100mg: White opaque hard cap. (size 4) marked G100 on cap and body. 300mg: Ivory opaque hard cap. (size 0) marked G300 on cap and body. 400mg: Orange opaque hard cap. (size 0) marked G400 on cap and body. 800mg: White to off-white, oval, biconvex film-ctd tab. marked G800 on one side. 100mg-100, A14.48; 300mg-100, A30.93; 400mg-100, A37.47; 800mg100, A82.91. S As adjunctive therapy in the treatment of partial seizures with and without secondary generalisation in adults and children r 6 years. As monotherapy in treatment of partial seizures with and without secondary generalisation in adults and adolescents r 12 years. P Effective dose, 900-3600mg/day. Initiate by dose titration: 300mg once daily on day 1, increasing to 300mg twice daily on day 2, then 300mg three times daily on day 3. Alternatively, initiate with 300mg 3 times/day on day 1. Thereafter, can be increased in 300mg/day increments every 2-3 days up to 3600mg/day max. See SPC. Renal impairment, haemodialysis: See
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
119
3.6 EPILEPSY,
CNS
SEIZURES
EXCIPIENTS Many products contain ingredients other than the active ingredient(s) listed in this index; these are known as excipients. These are â&#x20AC;&#x153;inertâ&#x20AC;? substances used as a diluent or vehicle for a drug and may cause unwanted effects in some individuals. The table below contains a list of excipients and when they should be avoided, when caution should be exercised or their possible side effects.
EXCIPIENT
PRECAUTION
Lactose
Should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Fructose Mannitol Sucrose Sorbitol
Should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Aspartame
Caution in phenylketonuria.
Ethanol Alcohol
May be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. Possible CNS and other effects.
Cetyl alcohol Propylene glycol Parabene Methyl parahydroxybenzoate Propyl parahydroxybenzoate Chlorocresol Metacresol Sunset yellow Polyethoxylated castor oil
May cause allergic reactions.
Associated with a fatal 'gasping syndrome' in neonates. Benzyl alcohol
May cause toxic and anaphylactoid reactions in infants and children up to 3 years of age.
Cetostearyl alcohol
May cause local skin reactions.
Arachis oil
Should not be taken/applied by patients known to be allergic to peanut. Patients with soya allergy should also avoid.
This table was compiled using a number of SPCs. References 1- IPHA website. www.medicines.ie. October 2006.
120
2
5
m
c
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b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS SPC. R Adjust according to renal function. Q q 12 years, as per adults. r 6 years: Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ kg/day. Doses up to 50mg/kg/day well tolerated. Divide total daily dose in 3 single doses with a 12 hour interval (max) between doses. B Consider discontinuation if acute pancreatitis develops. Caution in patients with mixed seizures incl. absences. Assess risks/benefits of prolonged therapy in children and adolescents. Monitor for signs of suicidal ideation and behaviours. False positives in dipstick tests (total urine protein). Withdraw gradually. Driving/ operating machinery. C Morphine (monitor for CNS depression). Antacids. A Infections (e.g. viral, UTI, RTI, otitis media, pneumonia), leucopenia, anorexia, increased appetite, psychiatric and nervous system disorders, visual disturbances, vertigo, hypertension, vasodilatation, dyspnoea, bronchitis, pharyngitis, cough, rhinitis, GI disorders, facial oedema, purpura, rash, pruritus, acne, arthralgia, myalgia, back pain, twitching, incontinence, impotence, fatigue, fever, peripheral or generalised oedema, abnormal gait, asthenia, pain, malaise, flu syndrome, decreased WBC, weight gain.
EPILEPSY, White oval scored tab. marked SABRIL. 100, A53.34.
2MO
ALSO SABRIL SACHETS Vigabatrin 500mg. Powder. 50, A28.59. S In combination with other AEDs for resistant partial epilepsy with or without secondary generalisation not controlled by all other AED combinations. Monotherapy for treatment of infantile spasms (West’s syndrome). P Initially 1g daily added to existing therapy. Adjust dosage by 0.5g increments at weekly intervals according to response. Max. 3g/ day. Q 10-15kg body weight, 0.5-1g daily. 1530kg body weight, 1-1.5g daily. 30-50kg body weight, 1.5-3g daily. q 50kg body weight, same as adult. Infants with West’s syndrome, initially 50mg/kg/day, up to 150mg/kg/day. D Pregnancy, lactation. B Caution: Elderly, renal impairment (ccQ 60ml/min), history of psychosis, depression or behavioural problems. Monitor for signs of suicidal ideation and behaviour; advise patients to seek medical advice immediately if occur. Examine visual field before treatment initiation and every 6 months; advise patients to report new visual problems; refer to ophthalmologist if develop and consider discontinuation. A Increased weight, somnolence, speech RIVOTRIL Roche disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, 2NO Benzodiazepine. Clonazepam 0.5mg, 2mg. Pinkish mental impairment (thought disturbance), tremor, visual field defect, vision blurred, diplopia, or white tab. resp. Both quarter-scored marked ROCHE and tab. strength on one side. 0.5mg-100, nystagmus, GI disorders, fatigue, oedema, irritability, excitation (children), agitation, A5.12; 2mg-100, A10.68. aggression, nervousness, depression, paranoid S All forms of epilepsy. P Initial R1mg daily. Increase gradually to reaction. maintenance dose, usually 4-8mg daily. TEGRETOL Novartis R Initially R 0.5mg daily. 2MO Q Up to 1 year, initially R 0.25mg daily, maintenance, 0.5-1mg daily. 1-5 years, R 0.25mg Dibenzazepine. Carbamazepine 100mg white daily, maintenance, 1-3mg daily. 5-12 years, scored tab. marked B/W on one side and GEIGY initially R 0.5mg daily, maintenance, 3-6mg daily. on reverse; 200mg white scored tab. Marked C/G For all ages increase gradually to maintenance on one side and G/K on reverse; 400mg white dose. oblong tab. scored and marked CG/CG one side 2NO and scored with tab. name on reverse. 100mg-100, A4.16. 200mg-100, A7.69. 400mg-50, A7.57; ALSO RIVOTRIL INJECTION Clonazepam 1mg in 400mg-56, A8.47. solvent plus 1ml diluent. Amp. 5, A3.80; 10, A7.59. 2MO S Status epilepticus. ALSO TEGRETOL ORAL SUSPENSION P 1mg by slow IV inj. Carbamazepine 100mg/5ml. Sugar-free liquid. Q 0.5mg by slow IV inj. See lit. 300ml, A7.27. D Acute pulmonary insufficiency, severe S Epilepsy, generalised tonic clonic and respiratory insufficiency, sleep apnoea, myasthenia partial seizures. gravis, severe hepatic insufficiency. Pregnancy, P Initially 100-200mg once or twice daily lactation. increasing slowly to 800mg-1.2g daily; in some B Elderly, debilitated, spinal or cerebellar cases 1600mg daily may be necessary. ataxia, alcohol/drug abuse, cirrhosis. Withdraw Q Liquid is recommended for children gradually. May modify reaction times. Closely under 5 years. Up to 1 year, 5-10ml daily; 1-5 monitor for depressive illness/suicidal ideation (or years, 10-20ml daily; 5-10 years, 400-600mg daily; history of). Driving/operating machinery. Contains 10-15 years, 600mg-1g daily. lactose. 2MO C Alcohol, hydantoins, phenobarbital, Na+ ALSO TEGRETOL RETARD Carbamazepine 200mg valproate. CYP450 inhibitors/inducers. Phenytoin, beige-orange cap.-shaped scored controlledprimidone. Anaesthetics, hypnotics, psychoactive release Divitab marked TEGRETOL 200 one side drugs, analgesics, muscle relaxants. and HC/HC on reverse; 400mg brown-orange cap.A Fatigue, muscle weakness, dizziness, shaped scored controlled-release Divitab marked ataxia, light-headedness, somnolence, muscular TEGRETOL 400 one side and ENE/ENE on reverse. hypotonia, co-ordination disturbances. 200mg-50, A4.76; 400mg-50, A9.37. V Same total daily dose as above but in SABRIL sanofi-aventis two divided doses.
2MO
2MO
GABA transaminase inhibitor. Vigabatrin 500mg.
ALSO TEGRETOL SUPPOSITORIES Carbamazepine
SEIZURES
3.6
125mg, 250mg. Suppos. 125mg-5, A7.05; 250mg-5, A9.16. S Short term (max. 7 days) treatment of patients for whom oral therapy is not possible. V When switching from oral therapy increase dose by 25%; max. 1g daily in divided doses rectally. D AV conduction abnormalities unless paced. B Cardiac, hepatic or renal disease. Perform liver function tests periodically. Blood dyscrasias. Pregnancy, lactation. Test blood regularly. C MAOIs, anticoagulants, antiepileptics, lithium, macrolide antibiotics (erythromycin), some Ca++ antagonists (verapamil, diltiazem), dextropropoxyphene, viloxazine, cimetidine, isoniazid, oral contraceptives, alcohol. A Gastric upset, diplopia, dry mouth, drowsiness and dizziness. Oedema and hyponatraemia. Blood dyscrasias, rashes, acute renal failure, hepatitis. See SPC.
TOPAMAX
Janssen-Cilag
2MO Sulphamate. Topiramate 25mg, 50mg, 100mg, 200mg. White, light yellow, yellow or salmon filmctd tabs marked with TOP and tab. strength. 25mg-60, A26.55; 50mg-60, A43.62; 100mg-60, A77.85; 200mg-60, A146.35.
2MO ALSO TOPAMAX SPRINKLE Topiramate 15mg, 25mg. Sprinkle cap. 15mg-60, A22.44; 25mg-60, A33.65. S Monotherapy or adjunctive therapy for adults and children over 4 years for partial onset seizures with or without secondarily generalised seizures and primary generalised tonic-clonic seizures. As adjunctive therapy for Lennox Gastaut Syndrome seizures. P Initially 25mg daily for 1 week, then increased by 25-50mg daily, in 2 divided doses at 1-2 week intervals. Target dose: Monotherapy, 100-200mg/day; maximum 500mg. Adjunctive therapy, 200mg-400mg in 2 divided doses; maximum 1600mg/day. Migraine: Initially 25mg daily for 1 week, then increased by 25mg/day at 1week intervals. Recommended dose 100mg/day in 2 divided doses. Maximum 200mg/day. Tab. should not be broken. Q Aged 4 to 16 years: Begin titration at 25mg nightly for 1 week, then increase at 1 or 2 week intervals by 1 to 3mg/kg/day in 2 divided doses; recommended daily dose 5-9mg/kg/day in 2 divided doses. Doses up to 30mg/kg/day generally well tolerated. Under 4 years: Not recommended. D Pregnancy (unless benefits outweigh risks), lactation. B Caution: Hepatic and moderate to severe renal impairment. Patients at risk of nephrolithiasis; maintain adequate hydration. May occur: increased incidence of mood disturbances and depression, acute myopia with secondary angle-closure glaucoma (rare). Monitor serum bicarbonate; reduce dose or withdraw if metabolic acidosis develops. Monitor for weight loss. Hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Driving/using machine. Withdraw gradually. C Caution: Phenytoin, carbamazepine, digoxin, oral contraceptives, lithium, hydrochlorothiazide, metformin, pioglitazone, glibenclamide, agents causing nephrolithiasis. A Nasopharyngitis, anaemia, anorexia,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
121
3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
Lacosamide 10mg/ml. Clear, colourless sln. 1 ampoule, A35.26. S Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. Sln for inf. is an alternative when oral admin. is temporarily not feasible. P Initially 50mg twice daily, increased after 1 week to an initial therapeutic dose of 100mg twice daily . Maximum daily dose: 400mg (in two 200mg doses). Sln for inf.: Infused over a period of 15 to 60 minutes twice daily. Can be administered IV without further dilution. R Consider age associated decreased renal clearance with an increase in AUC levels. Q Under 16 years, not recommended. Over 16 years, as per adults. D Known 2nd- or 3rd-degree atrioventricular (AV) block. Pregnancy, lactation. B Prolongations in PR interval may occur: Caution in patients with known conduction problems or severe cardiac disease (history of TRILEPTAL Novartis myocardial infarction or heart failure). Syrup contains Na+ propylhydroxybenzoate, Na+ 2NO methylhydroxybenzoate, sorbitol and aspartame. Dibenzazepine. Oxcarbazepine 150mg, 300mg, Sln for inf. contains Na+. Tabs contain soya 600mg. Pale grey green, yellow and pink oval lecithin. film-ctd tabs. scored both sides. 150mg-50, A8.85; C Caution: Carbamazepine, lamotrigine, 300mg-50, A18.41; 600mg-50, A36.71. pregabalin, starting or ending treatment with 2NO rifampicin or St John’s Wort, phenytoin, ALSO TRILEPTAL ORAL SUSPENSION phenobarbital. Oxcarbazepine 60mg/ml. Susp. with oral dosing A Depression, dizziness, balance disorder, syringe. 250ml, A36.50. headache, abnormal coordination, memory S Partial seizures with or without secondary generalised tonic clonic seizures. For use impairment, cognitive disorder, somnolence, tremor, nystagmus, diplopia, blurred vision, as monotherapy or adjunctive therapy. vertigo, nausea, vomiting, constipation, flatulence, P Initially 600mg daily in two divided pruritus, gait disturbance, asthenia, fatigue, fall, doses. Increase if necessary at weekly intervals using increment of up to 600mg daily. Usual daily skin laceration. dose 600-2400mg daily. Parke-Davis Q Under 6 years, not recommended; over ZARONTIN 2MO 6 years, initially 8-10mg/kg daily in two divided doses. Increase if necessary at weekly intervals Succinimide. Ethosuximide 250mg/5ml. Clear using increments of up to 10mg/kg daily. Max. slightly yellow to slightly pink raspberry flavoured 46mg/kg daily. syrup. 200ml, A4.33. B History of hypersensitivity to S Petit mal. carbamazepine. Monitor Na+ levels in at risk P 500mg daily increased as necessary by patients prior and during therapy. Cardiac disease. 250mg daily at intervals of 4-7 days up to 2g daily. Pregnancy, lactation. Q Under 6 years, initially 250mg daily C Phenobarbitone, phenytoin, adjusted by small increments to optimum carbamazepine, Na+ valproate, lamotrigine, response; 6-12years, same as adult. contraceptives, felodipine, verapamil, lithium. B Pregnancy, lactation. Hepatic or renal A Fatigue, asthenia, dizziness, headache, impairment. Withdraw gradually. somnolence, agitation, amnesia, apathy, ataxia, C Phenytoin, valproic acid. impaired concentration, confusion, depression, A Gastric and CNS disturbances. Skin emotional lability, nystagmus, tremor, nausea, rashes, blood dyscrasias, SLE. vomiting, constipation, diarrhoea, abdominal pain, hyponatraemia, acne, alopecia, rash, diplopia, ZONEGRAN Eisai vertigo, vision disorders. decreased appetite, depression, abnormal behaviour, aggression, agitation, anger, anxiety, bradyphrenia, confusional state, depressed mood, disorientation, expressive language disorder, insomnia, altered mood, mood swings, dizziness, parathesia, somnolence, amnesia, balance disorder, cognitive disorder, convulsion, abnormal coordination, attention disturbance, dysarthria, dysgeusia, hypoaesthesia, intention tremor, lethargy, memory impairment, mental impairment, nystagmus, impaired psychomotor skills, sedation, tremor, diplopia, blurred vision, visual disturbance, ear pain, tinnitus, vertigo, dyspnoea, epistaxis, nasal congestion, rhinorrhoea, GI disorders, dysuria, nephrolithiasis, pollakiuria, alopecia, pruritus, rash, arthralgia, muscle spasms, muscle twitching, muscular weakness, musculoskeletal chest pain, myalgia, hypersensitivity, fatigue, asthenia, abnormal feeling, gait disturbance, irritability, malaise, pyrexia, weight decreased/ increased.
2NO
VIMPAT
UCB Benzisoxazole derivative. Zonisamide 25mg, 50mg,
100mg. Hard caps. with white opaque body. Cap white, grey or red resp. marked with logo and ZONEGRAN followed by strength. 25mg-14, A10.95; 50mg-56, A58.07; 100mg-56, A77.59. S Adjunctive therapy in partial seizures, with or without secondary generalisation. P Usually 300-500mg daily. Initially, 50mg in two divided doses; may be increased after 1 week to 100mg daily and thereafter at one 2O weekly intervals in increments of up to 100mg. ALSO VIMPAT SYRUP Lacosamide 15 mg/ml. Clear, Renal/hepatic impairment and patients not slightly yellow to yellow-brown sln. 200ml, receiving CYP3A4-inducing agents: Consider two A50.75. weekly intervals. Can be admin. once or twice 2O daily after titration phase. ALSO VIMPAT SOLUTION FOR INFUSION Q Under 18 years, not recommended.
2O
Functionalised amino acid. Lacosamide 50mg, 100mg, 150mg, 200mg. Resp. pinkish, dark yellow, salmon or blue oval film-ctd tab. debossed with SP one side and 50, 100, 150 or 200 on the other. 50mg-14, A10.38; 100mg-14, A20.77; 100mg-56, A83.05; 150mg-14, A31.14; 150mg-56, 124.58; 200mg-56, A166.10.
122
D Pregnancy (unless clearly necessary), lactation. B Renal impairment. Acute renal failure, sustained increase in serum creatinine; discontinue. Hepatic impairment (not recommended if severe). Maintain hydration, avoid exposure to excessive temperatures. Risk factors for nephrolithiasis. Body weight Q40kg, elderly. Major haematological disturbances reported. Unexplained rash, pancreatitis; discontinue if occurs. Monitor for signs of severe muscle pain/weakness. Driving/ operating machines. Withdraw gradually. C Drugs that may lead to urolithiasis (avoid). Caution: Carbonic anhydrase inhibitors, anticholinergics or other drugs predisposing to heat related disorders, rifampicin. Caution with change in dosage of CYP3A4 inducers. A Anorexia, agitation, irritability, confusional state, depression, ataxia, dizziness, memory impairment, speech disorder, somnolence, diplopia, weight loss, hypersensitivity, rash, GI disorders, pyrexia.
3.7 PARKINSON’S, ALZHEIMER’S AND MS
ADARTREL
GSK
2MO Dopamine agonist. Ropinirole (as HCI) 0.25mg, 0.5mg, 2mg. White, yellow and pink resp. oval shaped film-cted tabs., marked GS on one side and MLE, TES, and GYG resp. on the other. 0.25mg-12, A2.89; 0.5mg-28, A12.26; 2mg-28, A33.87. S Moderate to severe idiopathic restless legs syndrome. P Initially 0.25mg once daily for 2 days. If well tolerated can increase to 0.5mg once daily for remainder of week 1. Week 2: 1mg once a day. The dose may be increased by 0.5mg/week over next 2 weeks to 2mg once a day (average dose). In some patients, dose may be increased gradually to a max. of 4mg once a day. Evaluate response after 3 months. R Clearance decreased in patients over 65 years of age. Increase dose gradually, titrate against response. Q Under 18 years, not recommended. D Severe renal or hepatic impairment. Lactation. Pregnancy (unless benefits outweigh risks). B Not for neuroleptic akathisia, tasikinesia or secondary restless legs syndrome. May cause worsening of symptoms with earlier onset, and reoccurrence of symptoms in early morning hours (review if occurs). Major psychotic disorders (do not use unless benefits outweigh risks). Impulse control disorders reported at high doses. Caution: Moderate hepatic impairment, severe cardiovascular disease. Driving/operating machines. Contains lactose. C CYP1A2 inhibitors. May require dose adjustment if HRT or smoking stopped or introduced. Avoid neuroleptics and other centrally active dopamine antagonists. A GI disorders, nervousness, syncope, somnolence, dizziness (incl. vertigo), fatigue.
AKINETON
L Farmaceutico SIT
2MO Anticholinergic. Biperiden (HCl) 2mg. White circular, biplanar tab. with bisecting score on one side. 100, A5.48. S Parkinsonism, drug-induced extrapyramidal symptoms.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
PARKINSON’S, ALZHEIMER’S
PRESCRIBING NOTES PARKINSON’S DISEASE Idiopathic Parkinsonism (characterised by tremor, rigidity and akinesia) is a progressive disease caused by degeneration of dopaminergic neurones in the nigro-striatal pathway, leading to deficiency of dopamine. Levodopa, a precursor of dopamine, is used in combination with a dopa-decarboxylase inhibitor such as benserazide or carbidopa as replacement therapy. Levodopa is converted to dopamine and can cause vomiting and hypotension, alleviated by reducing the amount which can pass through the blood-brain barrier. Patients should be advised at the beginning of treatment of limitations and possible side effects. These effects are pronounced in prolonged therapy. In the elderly low doses are advised for initiating treatment. Symptoms can be improved by increasing the dosage or by dividing the daily dose into smaller more frequent amounts. Controlled-release preparations may be beneficial. Entacapone, a reversible COMT inhibitor, is used in conjunction with levodopa and a dopadecarboxylase inhibitor (co-beneldopa or co-careldopa) to improve symptom control and reduce end of dose deterioration and incidence of dyskinesias. It acts by allowing more levodopa to pass through the blood brain barrier for conversion to dopamine. Monoamine oxidase-B inhibitors (MAO-B) including selegiline and rasagiline primarily degrade dopamine within the CNS. They are used with levodopa to reduce end of dose deterioration and have also been found effective as monotherapy in early PD. They might even have a neuroprotective effect that slows disease progression (even though evidence is not clear). Reports claim there may be increased risk of mortality in patients taking selegiline with levodopa compared to levodopa alone, but a causal link has not been established. Amantadine was initially developed as an antiviral agent. Although its exact mechanism of action is unclear, it seems to increase release of dopamine from the remaining cells of the substantia nigra of PD patients. This drug may improve mild tremor, rigidity, and bradykinesia. Dopamine receptor agonists act by stimulating surviving dopamine receptors. They are often used as monotherapy in younger patients where there is a risk of long term levodopa side effects. Dopamine agonists include ergot derivatives such as bromocriptine, cabergoline, lisuride, pergolide. Bromocriptine has a longer action than levodopa is useful for patients with severe early-morning disability. Ropinirole is a dopamine D2 agonist used as monotherapy in early PD or as an adjunct to levodopa, reducing the amount of time spent off and allowing levodopa dose reduction. Pramipexole is a D2/D3 agonist also effective both as early monotherapy and as an adjunct to levodopa treatment. Even though pramipexole is not as effective as levodopa in improving total features of the disease, as initial therapy it reduces risk of developing certain dopaminergic motor complications with significantly less development of wearing off, dyskinesias or on-off motor fluctuation. Somnolence may be more common than with other dopaminergic medications. Apomorphine is a potent stimulator of D1 and D2 receptors. Treatment is initiated in hospital in selected patients following at least 2 days anti-emetic domperidone therapy. Apomorphine has been found to be useful in patients experiencing off-periods with conventional levodopa therapy. Antimuscarinic drugs such as benzhexol, benztropine, biperiden, orphenadrine and procyclidine, often called anticholinergics, are less effective than levodopa in treating idiopathic disease. They can relieve mild tremor and stiffness but do not improve akinesia. There are no major differences between these drugs, but some patients do tolerate some better than others. Side effects include glaucoma and urinary retention, and confusional states particularly amongst the elderly. ALZHEIMER‘S DEMENTIA Donepezil, galantamine and rivastigmine are acetylcholinesterase inhibitors that prevent the breakdown of acetylcholine. Memantine is an NMDA receptor antagonist which blocks the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction. These drugs do not cure Alzheimer’s dementia, but may improve early symptoms. MULTIPLE SCLEROSIS Interferon beta is used in relapsing-remitting multiple sclerosis. It is used to reduce frequency and severity of clinical relapses. Glatiramer acetate is an immunomodulating agent. Initiation should be supervised by a specialist. It is indicated for the reduction in frequency of relapses in ambulatory patients with relapsing, remitting multiple sclerosis (MS) characterised by at least two attacks of neurological dysfunction over the preceding two-year period. MOTOR NEURONE DISEASE Riluzole has been used to treat amyotrophic lateral sclerosis (ALS) a form of motor neurone disease (MND). Riluzole, an antiglutamate, exerts a neuroprotective effect slowing the progressive deterioration in muscle strength and improving survival times. Treatment should be initiated by a specialist. References available on request. Revised: August 2007
AND
MS 3.7
P Parkinsonism: Initially: 1mg twice daily. Can increase by 2mg a day to a max. of 16mg daily. Spread doses evenly throughout day. Druginduced movement disorder: 1-4mg, one to four times daily as comcomitant medication to the neuroleptic. Q 1-2mg one to three times daily.
2MO ALSO AKINETON RETARD Biperiden (HCl) 4mg. Pro-longed release yellowish film-ctd oblong tab. scored on both sides. 100, A10.28. P Treatment normally initiated with Akineton 2mg tab., adjust dose individually and switch to Akineton Retard. Usual dose: 4-8mg to a max. of 12mg daily. R Cautious dosing necessary. D Narrow angle glaucoma, GI obstruction, megacolon, prostatic adenoma, diseases that can cause perilous tachycardia. B Caution: Elderly, patients with thyrotoxicosis, cardiac failure, tachycardia, prostatic adenoma, or who have tendency to convulsions. Withdraw gradually. C Other anticholinergic psychotropics, antihistamines, antiparkinsonian drugs, antispasmodics, quinidine, levodopa, carbidopa, metoclopramide, alcohol. A Anticholinergic effects. Confusion in high doses.
APO-GO
Clonmel
2M Dopamine agonist. Apomorphine HCI 10mg/ml. Soln for inj. in prefilled syringe, Penject. 30mg/ 3ml-5, price on request. S Disabling motor fluctuations (’on-off’ phenomena) in patients with Parkinson’s disease, which persist despite individually titrated treatment with levodopa and/or other dopamine agonists. P Initially 1mg (0.1ml) by SC inj. If inadequate response after 30 min., admin. 2nd dose of 2mg (0.2ml) by SC inj. Dose may be increased incrementally with r 40 min. between inj., until satisfactory motor response obtained. Maintenance: Once appropriate dose determined, admin. single SC inj. at 1st signs of an ’off’ episode. Max. total daily dose is 100mg and max. individual bolus inj. is 10mg. Levodopa/ domperidone dose may be reduced in some patients. Continuous Infusion: Patients with a good ’on’ period response during initiation, but whose overall control remains unsatisfactory, or who require many and frequent inj. may be commenced on or transferred to continuous SC inf. For dose, see SPC. Q Under 18 years, contraindicated. D Respiratory depression, dementia, psychotic diseases, hepatic insufficiency. Intermittent treatment in patients who have an ’on’ response to levodopa marred by severe dyskinesia or dystonia. Children and adolescents. Pregnancy, lactation. B Renal, pulmonary or cardiovascular disease, persons prone to nausea and vomiting. Initiation in elderly/debilitated patients. Preexisting cardiac disease/postural hypotension. Perform regular haematology tests with concomitant levodopa use. May cause exacerbations of neuropsychiatric disturbances. Consider dose reduction/termination of therapy if somnolence experienced. Driving / operating machines. Contains Na+ metabisulphite (ampoules) or bisulphite (pen). C Neuroleptics, clozapine, drugs with a
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
123
3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
30mcg/ml after reconstitution. Prices on request. S Slowing of disability progression and frequency of clinical relapses in ambulatory patients with relapsing multiple sclerosis who have had at least 2 attacks in the preceding 3 years ARICEPT Pfizer without evidence of progression between relapses. Treatment of patients who have a single 2NO demyelinating event with an active inflammatory Acetylcholinesterase inhibitor. Donepezil (HCl) process if severe enough to warrant treatment 5mg, 10mg. White and yellow round biconvex with IV corticosteroids, if alternative diagnoses film-ctd tab marked Aricept on one side and 5 have been excluded, and if high risk of and 10 resp. on reverse. 5mg-28, A38.78; 10mg-28, developing clinically definite MS. A54.37. P 30mcg once weekly by IM inj. S Mild to moderate severe Alzheimer’s Discontinue if patient develops chronic progressive dementia. disease. P Initially 5mg once daily at bedtime. Q Under 12 years, not recommended. Increase if necessary to 10mg at bedtime after 1 month. Initiated and supervised by an experienced D Natural or recombinant interferon beta, physician. Maintain as long as therapeutic benefit. history of severe depression or suicidal tendencies, uncontrolled epilepsy. Pregnancy, lactation. Q Not recommended. B History of seizures or depression, severe D Pregnancy (unless clearly necessary), hepatic or renal impairment, cardiac disease. lactation. Monitor blood chemistry, haematology and liver B Supraventricular conduction function tests. disturbances, history of GI ulceration, bladder C Drugs metabolised by liver enzymes outflow obstruction, seizures, asthma, COPD, (e.g. antiepileptics and some antidepressants), hepatic impairment. Contains lactose. Driving or caution. using machines. C Avoid cholinergics and anticholinergics. A Influenza-like syndrome, GI upset, Caution: Neuromuscular blockers, CYP3A4 inducers arthralgia, insomnia, dizziness, anxiety, rash, inj. site reactions, hypersensitivity. and inhibitors, CYP2D6 inhibitors (eg fluoxetine), alcohol, anaesthetics. AZILECT Lundbeck A Diarrhoea, muscle cramps, fatigue, 2NO nausea, vomiting, insomnia, cold, anorexia, hallucinations, agitation, aggressive behaviour, Irreversible MAO-B selective inhibitor. Rasagiline syncope, dizziness, rash, urinary incontinence, (as mesilate) 1mg. White, round, flat, bevelled headache, pain, accident. tab., marked with GIL and 1 underneath on one side. 28, A92.96. ARIPEZ Teva S Idiopathic Parkinson’s disease as 2NO monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of Acetylcholinesterase inhibitor. Donepezil (HCl) dose fluctuations. 5mg, 10mg. White and yellow film-ctd oval tabs, P 1mg once daily with or without marked 93 on one side and 7320 and 7321 on A A levodopa. reverse resp. 5mg-28, 49.68; 10mg-28, 70.66. Q Under 18 years, not recommended. S Symptomatic treatment of mild to D Severe hepatic insufficiency. moderately severe Alzheimer’s dementia. B Moderate hepatic impairment (avoid). P Initially 5mg once daily in the evening, Mild hepatic insufficiency (caution). Pregnancy, just prior to retiring. Can be increased after one lactation. month to 10mg once daily. Max. daily dose, C Other MAOIs or pethidine (contra 10mg.Initiated and supervised by experienced within 14 days of rasagiline discontinuation). physician. Avoid fluvoxamine, fluoxetine (See SPC), Q Not recommended. dextromethorphan, sympathomimetics (eg. nasal/ D Hypersensitivity to piperidine oral decongestants or cold medications containing derivatives. Lactation, pregnancy (unless clearly ephedrine or pseudoephedrine). Caution: SSRIs, necessary). tricyclic, tetracylic antidepressants, potent CYP1A2 B Anaesthesia, cardiovascular conditions inhibitors (e.g. ciprofloxacin), smoking, (vagotonic), GI conditions, history of asthma or entacapone. obstructive pulmonary disease (caution). May A Monotherapy: Headache, flu syndrome, cause bladder outflow obstruction, seizures. malaise, neck pain, allergic reaction, fever, angina Contains lactose. Withdraw gradually. pectoris, dyspepsia, anorexia, leucopenia, C Avoid other acetylcholinesterase arthralgia, arthritis, depression, vertigo, rhinitis, inhibitors, cholinergics and anticholinergics. Caution: CYP3A4 inhibitors and CYP2D6 inhibitors conjunctivitis, contact dermatitis, vesiculobullous rash, skin carcinoma, urinary urgency. Adjunct (e.g. fluoxetine), succinylcholine, neuro-muscular therapy: Dyskinesia, dystonia, abnormal dreams, blockers, b-blockers. ataxia, abdominal and neck pain, falls, postural A GI/abdominal disturbances, muscle hypotension, GI disorders, anorexia, dry mouth, cramps, fatigue, insomnia, headache. Common cold, anorexia, hallucinations, agitation, aggressive arthralgia, tenosynovitis, weight loss, rash. behaviour, syncope, dizziness, rash, pruritus, BETAFERON Bayer Schering urinary incontinence, pain, accident. Extrapyramidal symptoms. 2NT Antiviral/immunoregulator. Interferon beta-1b AVONEX Biogen 0.25mg/ml. Powder in vial plus pre-filled glass 2NT syringe of solvent containing 1.2ml sterile sodium Immunomodulator. Interferon b1a 30mcg. Prefilled chloride sln (0.54% w/v). 1 month’s supply-15 x 3ml. Price available on request. syringe: 30mcg/0.5ml; vial with BIO-SET device: narrow therapeutic range, antihypertensives. A Inj. site reactions, nausea, vomiting, transient sedation, somnolence, transient mild confusion, visual hallucinations.
124
S Single demyelinating event with active inflammatory process severe enough to warrant treatment with IV corticosteroids, if high risk of developing clinically definite multiple sclerosis (MS). Relapsing remitting MS and two or more relapses within last two years. Secondary progressive MS with active disease. P 0.25mg (8MIU) by SC inj. every other day. Should be initiated by physician experienced in MS. See SPC. Q Under 18 years, not recommended. D Pregnancy, lactation. Hypersensitivity to albumin. History of severe depression or suicidal tendencies. Decompensated liver disease, uncontrolled epilepsy. B History of seizures or depression, cardiac disorders, myelosuppression, renal impairment, thyroid dysfunction. Monitor for symptoms of depression, suicidal ideation, fever, infection and hypersensitivity reactions; consider withdrawal if occur. Monitor haematology, liver enzymes and renal function. C Avoid immunomodulators other than corticosteroids or ACTH. Caution: Cyto. P450 substrates, drugs with effect on haematopoetic system. A inj. site reactions, flu-like symptoms, hypersensitivity reactions, menstrual disorders, CNS effects.
CABASER
Pharmacia
2NO D2 agonist. Cabergoline 1mg, 2mg, 4mg. White, oval, concave scored tabs., engraved 7 on the left of breakline and 01, 02, or 03 resp. on the right of it. 1mg-20, A79.80; 2mg-20, A92.87; 4mg-16, A86.67. S Parkinson’s disease, as 2nd line therapy where non-ergot compound inappropriate, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor. P Initially 1mg once daily, increase with 0.5-1mg/day increments every week (initial weeks) or bi-weekly to 2-3mg/day. D Hypersensitivity to ergot alkaloids. History of pulmonary, pericardial and retroperitoneal fibrotic disorders. Anatomical evidence of cardiac valvulopathy of any valve. Pregnancy, lactation. B End-stage renal failure, patients on haemodialysis. Severe hepatic insufficiency. Respiratory disorders, CVD (or history of). Raynaud’s syndrome, peptic ulcer, GI bleeding, psychosis. Driving/using machines. Contains lactose. C Avoid ergot alkaloids, macrolide antibiotics and drugs with dopamine antagonist activity. A Dyskinesia, hyperkinesia, hallucinations, confusion, dizziness, hypotension, symptomatic pleural effusion/fibrosis, nausea, vomiting, dyspepsia, gastritis, decreased BP in minority.
CELANCE
Lilly
2MO Dopamine agonist. Pergolide (mesilate) 50mcg, 250mcg, 1000mcg. Ivory, green or pink rectangular scored tabs. marked LILLY and 4131, 4133 or 4135 resp. 50mcg-100, A41.48; 250mcg-100, A49.80; 1000mcg-100, A169.81. S As monotheraphy or adjunct to levodopa in Parkinson’s disease where non-ergot compound failed. P Monotherapy: Day 1: 50mcg in the evening; day 2-4: 50mcg at noon and in evening;
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
3.7 PARKINSON’S, ALZHEIMER’S day 5-7: 50mcg in morning and noon and 100mcg in the evening (total dose: 200mcg). Then increase incrementally every 3 days up to 500mcg in morning, noon and evening on day 30 (total dose:1500mcg). See SPC for detailed titration schedule. After day 30 increase by max. 250mcg twice a week. Max 3mg/day. As adjunct to levodopa: Initially 50mcg daily for first 2 days, increasing by 100-150mcg daily every third day over next 12 days. Then increase by 250mcg daily every third day until optimal response. Usually in 3 divided doses; max. 3mg daily. Reduce levodopa dose cautiously during titration. Q Not recommended. D History of fibrotic disorders. Evidence of cardiac valvulopathy determined by pre-treatment echocardiography. B Perform cardiovascular evaluation before therapy and regularly monitor for progressive fibrosis thereafter. Fibrotic/serosal inflammatory disorders have occurred after prolonged use. Perform baseline investigations of erythrocyte sedimentation rate or other inflammatory markers, lung function/chest X-ray and renal function prior to initiation. Withdraw gradually. Risk of hypotension. History of psychosis. Patients prone to cardiac dysrhythmias or with significant underlying cardiac disease. Driving/using machines (somnolence/sudden sleep onset may occur). Pathological gambling, increased libido and hypersexuality have been reported. Contains lactose. Pregnancy, lactation. C Dopamine antagonists, antihypertensives, anticoagulants, other drugs known to affect protein binding. A Pain, abdominal pain, GI disorders, pyskinesia, hallucinations, somnolence. somnolence, rhinitis, dyspnoea, diplopia, cardiac valvulopathy (incl. regurgitation) and related disorders (pericarditis, pericardial effusion).
AND
MS
CNS
syringes. S Treatment of patients who experienced a well-defined 1st clinical episode and are at high risk of developing clinically definite MS (CDMS). Reduction in frequency of relapses in ambulatory patients with relapsing, remitting multiple sclerosis (MS) characterised by at least two attacks of neurological dysfunction over the preceding twoyear period. Not indicated in primary or secondary progressive MS. P 20mg by SC inj. once daily. Use different site every day. Self-inj. sites include abdomen, arms, hips, thighs. Q 12-18 years, as per adults (limited data). Under 12 years, not recommended. D Pregnancy. B Caution: Pre-existing cardiac disorders. In renal impairment, monitor renal function. May occur (rarely): Convulsions and/or anaphylactoid or allergic reactions. Lactation. C No formal evaluation. Potentially, protein-bound drugs. Corticosteroids. A Infections. benign skin neoplasm, neoplasm, lymphadenopathy, hypersensitivity, anorexia, increased weight, anxiety, depression, nervousness, headache, dysgeusia, hypertonia, migraine, speech disorder, syncope, tremor, diplopia, eye disorder, ear disorder, palpitations, tachycardia, vasodilatation, dyspnoea, cough, rhinitis seasonal, post-injection reactions (see SPC).
D Hypersensitivity to piperidine derivatives. Pregnancy, lactation. B Caution: Anaesthesia, cardiovascular conditions, patients at risk of ulcers (monitor), asthma or COPD. May occur: Urethral obstruction, seizures, exacerbation or induction of extrapyramidal symptoms. Driving/using machines. Contains lactose. C Caution: CYP3A4 inducers and inhibitors, alcohol, anticholinergics, CYP2D6 inhibitors, succinylcholine, other neuro-muscular blocking agents, cholinergic agonists, b-blockers. A Cold, anorexia, hallucinations, agitation, aggression, syncope, dizziness, sleep disturbances, GI disorders, rash, pruritus, muscle spasms, incontinence, headache, fatigue, pain, accident.
DONESYN
Clonmel
2NO
Acetylcholinesterase inhibitor. Donepezil (HCl) 5mg, 10mg. White and yellow round biconvex film-ctd tab marked D9EI on one side and 5 and 10 resp. on reverse. 5mg-28, A44.49, 10mg-28, A62.36. S Mild to moderate severe Alzheimer’s dementia. P Initially 5mg once daily at bedtime. Increase if necessary to 10mg at bedtime after 1 month. Initiated and supervised by experienced physician. Maintain as long as therapeutic benefit. Q Not recommended. DONECEPT Actavis D Pregnancy (unless clearly necessary), 2NO lactation. Acetylcholinesterase inhibitor. Donepezil (HCl) B Supraventricular conduction 5mg, 10mg. White and pale yellow, round, disturbances, history of GI ulceration, bladder biconvex film-ctd tabs marked DZ 5 and DZ 10 outflow obstruction, seizures, asthma, COPD, A A resp. 5mg-28, 47.43; 10mg-28, 68.53. hepatic impairment. Contains lactose. Driving or S Mild to moderate severe Alzheimer’s using machines. dementia. C Avoid cholinergics and anticholinergics. P Initially 5mg once daily at bedtime. Caution: Neuromuscular blockers, CYP3A4 inducers Increase if necessary to 10mg at bedtime after 1 and inhibitors, CYP2D6 inhibitors (eg. fluoxetine), COMTESS Orion month. Initiated and supervised by experienced alcohol, anaesthetics. 2MO physician. Maintain as long as therapeutic benefit. A Diarrhoea, muscle cramps, fatigue, Cathecol-o-methyl transferase inhibitor. Q Not recommended. nausea, vomiting and insomnia, headache. Entacapone 200mg. Brown-orange oval film-ctd D Pregnancy, lactation. Common cold, anorexia, hallucinations, agitation, A tab. marked Comtess one side. 100, 75.97. B May cause vagotonia, supraventricular aggressive behaviour, syncope, dizziness, rash, conduction disturbances, ulcers, bladder outflow pruritis, urinary incontinence, pain, accident. S As an adjunct to levodopa/benserazide or levodopa/carbidopa in patients with Parkinson’s obstruction, seizures. Caution with asthma, COPD. DOZEPT Rowex Contains lactose. Driving or using machines. disease and end-of-dose motor fluctuations, who C Avoid cholinergics and anticholinergics. 2 N O cannot be stabilised on those combinations. Caution: CYP3A4 inducers and inhibitors (see P 200mg taken with each dose of Acetylcholinesterase inhibitor. Donepezil HCl 5mg, levodopa/dopa decarboxylase inhibitor. Max. dose Appendix I), CYP2D6 inhibitors (eg. fluoxetine), 10mg. Resp., white (diameter 7mm) or yellow neuromuscular blockers, b-blockers, alcohol, 200mg ten times daily. See SPC. (diameter 9mm) film-ctd tabs. 10mg tabs have a anaesthesia. Q Not applicable. score line and can be divided into equal halves. D Liver impairment, phaeochromocytoma. A GI disorders, headache. Common cold, 5mg-28, A45.65; 10mg-28, A64.01. anorexia, hallucinations, agitation, aggressive Pregnancy, lactation. Previous history of S Symptomatic treatment of mild to behaviour, syncope, dizziness, insomnia, rash, Neuroleptic Malignant Syndrome and/or nonmoderately severe Alzheimer’s dementia. pruritis, urinary incontinence, muscle cramps, traumatic rhabdomyolysis. P Initially 5mg once daily at bedtime. fatigue, pain, accident. B Rhabdomyolysis 2ndary to severe Increase if necessary to 10mg at bedtime after 1 dyskinesias or Neuroleptic Malignant Syndrome month. Initiated and supervised by an experienced Helsinn Birex (NMS) reported. May aggravate levodopa-induced DONELINN physician. Maintain as long as therapeutic benefit. orthostatic hypotension. Withdraw slowly. Driving/ 2 N O D Hypersensitivity to piperidine using machines. Acetylcholinesterase inhibitor. Donepezil (HCl) derivatives. Lactation, pregnancy (unless clearly C Non-selective MAOIs, TCADs, NA 5mg, 10mg. Resp. white or pale yellow, round, necessary). reuptake inhibitors, catechol-like drugs biconvex film-ctd tabs, marked DZ5 or DZ10. 5mg- B Caution: Anaesthesia, cardiovascular metabolised by COMT, iron preparations. A A 28, 27.41; 10mg-28, 38.41. conditions (sick sinus syndrome, sinoatrial or A Dyskinesias, nausea, GI disorders, S Mild or moderate dementia in atrioventricular block), patients at risk of discoloured urine. Slight decrease in Hb, Alzheimer’s disease. developing ulcers (monitor), asthma or obstructive erythrocyte count and haematocrit. P Initially 5mg once daily at bedtime. If pulmonary disease. May occur: Bladder outflow necessary increase to 10mg (max) after 1 month. obstruction, seizures, exacerbation or induction of COPAXONE sanofi-aventis Maintain as long as therapeutic benefit exists. extrapyramidal symptoms. Driving/operating 2NT Hepatic impairment: Mild to moderate, adjust machines. Contains lactose. Immunomodulator. Glatiramer acetate 20mg according to individual tolerance; severe, no data. C CYP3A4 inducers and inhibitors (see (equiv. 18mg glatiramer base). 28 pre-filled Q Not recommended. Appendix I), CYP2D6 inhibitors (e.g. fluoxetine),
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
MIMS Ireland
A fundamental part of every doctorâ&#x20AC;&#x2122;s working day
3.7 PARKINSON’S, ALZHEIMER’S succinylcholine, other neuro-muscular blocking agents, cholinergic agonists, b-blocking agents. A Common cold, anorexia, hallucinations, agitation, aggressive behaviour, syncope, dizziness, insomnia, GI disorders, rash, pruritis, muscle cramps, urinary incontinence, headache, fatigue, pain, accident.
DUODOPA
AND
MS
CNS
10mg daily; 3rd week, 15mg daily. From week 4 onwards, 20mg once daily. Maintenance dose: 20mg once daily (max dose). Moderate renal impairment: 10mg/day, can be increased to 20mg using standard titration if well tolerated after 7 days. Severe renal impairment: 10mg/day. Q Under 18 yrs, not recommended.
P Initially 1.5mg morning and evening with meals; may be increased by 1.5mg twice daily at min. 2 week intervals. Maintain patient on highest tolerated dose; up to max. 6mg twice daily. Oral soln. and caps. may be interchanged at equal doses. Q Not applicable.
2NO
2NO
Solvay ALSO EBIXA ORAL DROPS Memantine (HCl) 10mg/
g. Soln. 50g, A90.00; 100g, A180.00. Dopamine precursor/dopa decarboxylase inhibitor. P Initially, 10 drops (5mg) daily (week 1); 2 Levodopa 20mg, carbidopa (as monohydrate) 5mg/ nd week, 20 drops (10mg) daily; 3rd week, 30 ml. White to slightly yellow intestinal gel. 100ml-7, drops (15mg) daily. From week 4 onwards: 40 drops (20mg) once daily. Maintenance dose: 40 price available on request. drops (20mg) once daily max. Moderate renal S Treatment of advanced levodopaimpairment: 20 drops (10mg) daily, can be responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available increased to 40 drops (20mg) using standard titration if well tolerated after 7 days. Severe renal combinations of Parkinson medicinal products impairment: 20 drops (10mg) daily. have not given satisfactory results. Q Under 18 yrs, not recommended. P Gel for continuous intestinal admin. 3 doses/day divided into the following. The morning B Severe hepatic impairment. Epilepsy. dose: Usually 5-10ml (max. 15ml) admin. by pump. Conditions in which urine pH is elevated. MI, CHF, uncontrolled hypertension (closely supervise). Continuous maintenance dose: Range, 1-10ml/ Contains lactose (tablets) / sorbitol (drops). hour; usually 2-6ml/hour. Extra bolus doses: C Amantadine, ketamine, Normally 0.5-2.0ml as required. If the need for dextromethorphan, L-dopa, dopaminergic extra bolus doses q 5/day the maintenance dose agonists, anticholinergics, barbiturates, should be increased. See SPC. neuroleptics, dantrolene, baclofen, cimetidine, Q Not recommended. ranitidine, procainamide, quinidine, quinine, D Narrow-angle glaucoma, severe liver/ nicotine, hydrochlorothiazide renal insufficiency, severe HF, severe cardiac A Dizziness, constipation, hypertension, arrhythmia, acute stroke. Lactation. headache, somnolence. B Not for drug-induced extrapyramidal reactions. Caution: Severe cardiovascular or ELDEPRYL Orion pulmonary disease; bronchial asthma, renal, hepatic or endocrine disease, or history of peptic, 0 M O ulcer disease or of convulsions, chronic wide-angle Monoamine oxidase-B inhibitor. Selegiline (HCl) 5mg. White scored tab. 100, A68.05. glaucoma (control IOP), abrupt dosage changes. S Parkinson’s disease or symptomatic History of MI. Monitor for mental changes, parkinsonism, alone to delay the need for depression with suicidal tendencies. Psychosis (or history of). General anaesthesia (patients must be levodopa or in conjunction with levodopa permitted to take fluids and medicinal products by particularly in patients on levodopa who develop on-off symptoms or other dyskinesias. mouth). Evaluate hepatic, haematopoietic, P Initially 1 increasing to 2 if necessary. cardiovascular and renal function periodically. Q Not applicable. Previous surgery in upper abdomen may lead to D Pregnancy, lactation. difficulty in performing gastrostomy or jejunostomy. Reduced ability to handle the system B Peptic/duodenal ulcer, labile can lead to complications (caregiver should assist). hypertension, cardiac arrhythmias, severe angina pectoris, severe liver or kidney dysfunction, Worsening of bradykinesia may indicate an psychosis. obstruction in device. Pregnancy (unless clearly C Non-specific MAOIs (contra). Avoid necessary). fluoxetine, sertraline, paroxetine, venlafaxine, C Contra: Non-selective MAOIs and pethidine. Caution: Moclobemide, TCAs, oral selective MAO type A inhibitors. Caution: contraceptives. Antihypertensives, TCAs, anticholinergics, dopamine receptor antagonists, benzodiazepines, A Postural hypotension, involuntary movements , cardiac arrhythmias, vertigo (reduce isoniazide, phenytoin, papaverine, selegiline, levodopa dose). Dry mouth, transient ALAT COMT inhibitors (tolcapone, entacapone), increase, sleeping disorders. amantadine, sympathicomimetics, iron, protein rich diet. EXELON Novartis A Anorexia, hallucinations, confusion, nightmares, sleepiness, fatigue, sleeplessness, 2N depression, euphoria, dementia, psychotic Acetylcholinesterase inhibitor. Rivastigmine (as episodes, feeling of stimulation, dyskinesias, hydrogen tartrate) 1.5mg, 3mg, 4.5mg, 6mg. choreatic movements and dystonia, ‘‘ON-OFF’’ Yellow, orange, red or orange/red caps. marked episodes, dizziness, palpitations, irregular with cap. name and strength. 1.5mg-28, A36.33; heartbeat, orthostatic hypotension, syncope, 1.5mg-56, A72.65; 3mg, 4.5mg and 6mg-28; nausea, vomiting, dry mouth, bitter taste. A37.33; 3mg, 4.5mg and 6mg-56, A74.66.
2M
EBIXA
Lundbeck
2NO NMDA-receptor antagonist. Memantine (HCl) 10mg. White to off-white oblong film-ctd tab. scored both sides. 28, A50.40; 56, A100.80. S Moderate to severe Alzheimer’s disease. P Initially, 5mg daily (week 1); 2nd week,
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2NO ALSO EXELON ORAL SOLUTION Rivastigmine (as hydrogen tartrate) 2mg/ml. Soln. with oral dosing syringe. 120ml, A149.83. S Symptomatic treatment of mild to moderately severe Alzheimer’s dementia or dementia associated with idiopathic Parkinson’s disease.
ALSO EXELON PATCH Rivastigmine 4.6mg, 9.5mg per 24 hours. Transdermal patches. Both strengths30, A102.61. S Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. P Initially 4.6mg/24 h. After min. 4 weeks should be increased to 9.5mg/24 h (maintenance dose). Switching from caps or soln, see SPC. Q Not applicable. D Severe liver impairment. Pregnancy (unless essential), lactation. B Sick sinus syndrome or conduction defects, renal/hepatic impairment, history of GI/ duodenal ulceration, asthma, COPD, urinary obstructions, seizures. Driving, using machines. C Cholinomimetics, anticholinergics, muscle relaxants. A Anorexia, weight loss, GI disorders, asthenia, somnolence, dizziness, headache, tremor, agitation, confusion.
KEMADRIN
GSK
2MO Anticholinergic. Procyclidine (HCl) 5mg. White scored tab. marked WELLCOME S3A. 100, A6.75. S Parkinsonism, particularly drug-induced. P Initially 2.5mg three times daily after meals increasing at intervals of 2 or 3 days by 2.55mg daily; usual max. 30mg daily. Q Not recommended. D Tardive dyskinesia. B GI obstruction. Narrow angle glaucoma. Prostatic hypertrophy. Cardiac disorders. Withdraw slowly. C Phenothiazines, antihistamines, antidepressants, amantadine, butyrophenones. A Anticholinergic effects. Dizziness, mental confusion, impaired cognition and memory, disorientation, anxiety, agitation, hallucinations in high doses.
MADOPAR
Roche
2MO Dopamine precursor/dopa decarboxylase inhibitor. ’62.5’: levodopa 50mg, benserazide (HCl) 12.5mg. ’125’: levodopa 100mg, benserazide (HCl) 25mg. ’250’: levodopa 200mg, benserazide (HCl) 50mg. ’62.5’ and ’125’, white scored dispersible tabs. marked with strength. ’250’, brown/blue hard cap. All marked ROCHE. ’62.5’-100,A9.61; ’125’-100, A17.05; ’250’-100, A26.04. S Idiopathic post-encephalitic Parkinsonism. P Patients not receiving levodopa, initially 1 x ’62.5’ three or four times daily after meals increasing by 1 x ’125’ daily once or twice weekly. Usual maintenance, 4-8 x ’125’ daily in divided doses. See SPC. Not recommended for patients under 25 years. R Initially 1 x ’62.5’ once or twice daily increasing by 1 x ’62.5’ every third or fourth day. Q Not recommended. D Patients Q 25 yrs, severe psychoses, narrow angle glaucoma, history of malignant melanoma. Pregnancy, lactation. B Cardiovascular, hepatic, renal,
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
C Avoid antipsychotics. Caution: Drugs inhibiting or eliminated by renal tubular secretion (eg. cimetidine, amantadine, mexiletine), sedating drugs, alcohol. Levodopa and other antiparkinsonian products, caution during Mirapexin titration. A Abnormal dreams, behavioural symptoms of impulse control disorders and compulsions, confusion, hallucinations, insomnia, restlessness, dizziness, dyskinesia, somnolence, MIRAPEXIN Boehringer Ing. amnesia, headache, visual disturbance including vision blurred and visual acuity reduced, 2MO hypotension, nausea, constipation, vomiting, Selective dopamine agonist. Pramipexole (mg base/mg salt as monohydrate) 0.088/0.125mg, 0.18/ fatigue, peripheral oedema, weight decrease. 0.25mg, 0.7/1mg. White tabs. 0.088 no score; NEUPRO UCB others scores on both sides. 0.088mg-30, A9.16; 2MO 0.18mg-100, A60.86; 0.7mg-100, A243.98. S Idiopathic Parkinson’s disease (PD), Dopamine agonist. Rotigotine 1mg, 2mg, 3mg, alone or in combination with levodopa. Moderate 4mg, 6mg, 8mg per 24 hrs. Transdermal patch. to severe idiopathic Restless Legs Syndrome (RLS). 1mg/24h-28, A101.31; 2mg/24h-28, A104.56; 3mg/ P PD: Initially 0.088mg base (0.125mg salt) 24h -28, A138.01; 4mg/24h-28, A121.61; 6mg/24hthree times daily, doubling the dose every 5-7 28, A140.63; 8mg/24h-28, A158.94. days to 0.36mg base (0.5mg salt) three times daily. S Signs and symptoms of early-stage If necessary, increase further by 0.54mg base idiopathic Parkinson’s disease as monotherapy (i.e. (0.75mg salt) daily at weekly intervals to achieve without levodopa) or in combination with optimal effect; max. 3.3mg base (4.5mg salt) daily. levodopa, i.e. over the course of the disease, When co-prescribed, reduce dose of levodopa through to late stages (end of dose or ’on-off’ while titrating pramipexole. RLS: Initially 0.088mg fluctuations). Moderate to severe idiopathic base (0.125mg salt) once daily 2-3 hrs before Restless Legs Syndrome (RLS) in adults. bedtime; may be increased every 4-7 days to max. P Apply patch daily and replace every 24 0.54mg base (0.75mg salt) per day. hrs. PD: Early stage: Initially, 2mg/24h, then Q Under 18 years, not recommended. increase in weekly increments of 2mg/24h to max. 2MO 8mg/24h. Advanced stage: Initially, 4mg/24h, then ALSO MIRAPEXIN PROLONGED RELEASE increase in weekly increments of 2mg/24h to max. Pramipexole (dihydrochloride monohydrate) 16mg/24h. For doses q 8mg/24h use multiple 0.26mg, 0.52mg, 1.05mg, 2.1mg, 3.15mg. White to patches. Discontinue gradually in decrements of off white tablets embossed with Boehringer 2mg/24h every other day. RLS: Initially 1mg/24h; Ingelheim company symbol on one side and either then increase in weekly increments of 1mg/24h, P1, P2, P3, P4 or P5 on the other side. 0.26mg-30, up to max. 3mg/24h. Reconsider treatment A28.28; 0.52mg-30, A56.57; 1.05mg-30, A113.14; duration every 6 months. Discontinue gradually in 2.1mg-30, A226.28, 3.15mg-30, A339.41. 1mg/24h decrements daily every other day. S Idiopathic Parkinson’s disease, alone Q Children and adolescents, not (without levodopa) or in combination with recommended. levodopa. D MRI or cardioversion. Pregnancy, P Initial titration: Week 1: 0.26mg base lactation. (0.375mg salt) daily; Week 2: 0.52mg base (0.75mg B Monitor BP esp. at start of treatment. salt) daily; Week 3: 1.05mg base (1.5mg salt) daily; May cause somnolence/sudden sleep onset; if necessary, increase by 0.52mg base (0.75mg salt) consider dose reduction/discontinuation if occurs. daily up to 3.15mg base (4.5mg salt) max. Patients Compulsive disorders have been reported. May already taking Mirapexin tab. can be switched to occur: Hallucinations, fibrotic complications. prolonged-release tab. at same daily dose. Monitor eyes regularly and if vision abnormalities Maintenance: 0.26mg-3.15mg base (0.375mgoccur. Do not apply external heat to patch area. 4.5mg salt); Withdraw gradually. Renal Rotate appl. site (do not use same site within 14 impairment: ccq50ml/min, no dose adjustment. days). Assess if persistent appl. site reactions occur. 30QccQ50ml/min: Initially 0.26mg every other Discontinue if generalised skin reaction occurs. day; increasing by 0.26mg base (0.375mg salt) if Severe hepatic impairment. Unexpected necessary at weekly intervals up to max 1.57mg accumulation of rotigotine may occur at acute base (2.25mg salt); ccQ30ml/min, not worsening of renal function. Withdraw gradually. recommended. Driving / using machinery. Q Under 18 years, not recommended. C Avoid dopamine antagonists. Caution: D Pregnancy (unless clearly necessary), CNS depressants, alcohol. lactation. A PD: Anorexia, hallucination, anxiety, B Caution: Severe CVD, renal impairment. dizziness, dyskinesia, lethargia, orthostatic Inform patients that hallucinations can occur. In hypotension, cough, hiccup, hyperhydrosis, combination with levodopa, dyskinesia can occur erythema, peripheral oedema, asthenic conditions, during Mirapexin initial titration; decrease hepatic enzyme increased. RLS: Fatigue, irritability, levodopa dose if occurs. Pathological gambling, hypersensitivity, sleep disorder, sexual desire increased libido and hypersexuality reported. Only disorder, hypertension. Both indications: Sleep treat patients with psychotic disorders if benefits attacks, abnormal dreams, insomnia, somnolence, outweigh risks. Ophthalmologic monitoring headache, GI disorders, pruritus, appl. site recommended at regular intervals or if vision reactions. abnormalities occur. Monitor BP. Neuroleptic pulmonary or endocrine disease. Peptic ulceration. Psychiatric disturbances. Wide angle glaucoma. Osteomalacia. Monitor blood values and hepatic, renal and cardiovascular function. C Drugs affecting central amines. MAOIs, antihypertensives and sympathomimetics. A Nausea, vomitimg, anorexia. Postural hypotension. Involuntary movements. Cardiac and CNS disturbances. Urine discolouration.
malignant syndrome reported with abrupt withdrawal. Driving/operating machinery (somnolence and sudden sleep onset may occur).
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NITOMAN 2MO
Benzoquinolizine. Tetrabenazine 25mg. Yellowishbuff, circular, bevel-edged scored tab. marked CL25. 112, A155.17. S Control of disorders of movement associated with organic disease of the CNS, such as Huntington’s chorea, hemiballismus and senile chorea. P Initially, v-1 three time daily; can be increased by 25mg a day every three or four days up to 200mg daily or until limit of tolerance. If no improvement at max. dose in 7 days, benefit is unlikely. B Pregnancy, lactation (avoid). Driving/ using machines. Neuroleptic malignant syndrome (discontinue if occurs). Contains lactose. C Contra: Reserpine, MAOIs (within 2 weeks). Caution: Levodopa. A Drowsiness, hypotension, depression.
PARLODEL
Meda
2MO Dopamine agonist. Bromocriptine (as mesylate) 2.5mg. White tab. angle scored and marked XC one side and Sandoz on reverse. 30, A6.44; 100, A21.47.
2MO ALSO PARLODEL CAPSULES Bromocriptine (as mesylate) 5mg. Blue/white cap. coded PARLODEL 5. 100, A41.84. S Parkinsonism. P Week 1: 1-1.25mg at bedtime.Week 2: 2- 2.5mg at bedtime. Week 3: 2.5mg twice daily.Week 4: 2.5mg three times daily. Increase further at three to fourteen day intervals in increments of 2.5mg to 10-40mg daily in three divided doses. All doses should be taken during meals. Q Not recommended. D Toxaemia of pregnancy, puerperal postpartum hypertension. Hypersensitivity to ergot alkaloids. B History of peptic ulceration, psychotic or severe CVD. Pleural effusions observed with longterm high doses. Perform regular gynaecological assessment for women receiving prolonged therapy. Observe patients on long-term high doses for manifestations of retroperitoneal fibrosis. C Alcohol, erythromycin, psychoactive agents, drugs effecting BP. A Postural hypotension, nausea, vomiting, mild constipation, dry mouth, leg cramps, hypertension, MI, strokes, drowsiness, confusion, hallucinations, headache, dizziness, seizures, episodes of reversible pallor of fingers and toes induced by cold, psychomotor excitation, dyskinesia, retroperitoneal fibrosis.
REBIF
Merck Serono
2NT
Immunomodulator. Interferon beta-1a, 8.8mcg/ 0.2ml, 22mcg/0.5ml, 44mcg/0.5ml. Clear to opalescent soln. in pre-filled syringe or cartridge. Syringes: 8.8mcg-6 and 22mcg-6 (initiation pack), A1092.57; 22mcg-12, A1042.19; 44mcg-12, A1428.68. Cartridges: Initiation Pack-2, A714.42; 22mcg -4, A1042.3; 44mcg -4, A1428.84. S Treatment of relapsing multiple sclerosis. P Weeks 1 and 2, 8.8mcg by SC inj. 3 times weekly. Weeks 3 and 4, 22mcg 3 times weekly. From week 5 onwards, 44mcg. Q Under 12 years, not recommended. 12Cambridge 16 years, 22mcg 3 times weekly. D Current severe depression and/or
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS suicidal ideation. Pregnancy, lactation. B Caution: Previous or current depressive disorders, antecedents of suicidal ideation, history of seizures, treatment with anti-epileptics (particularly uncontrolled epilepsy), severe renal/ hepatic failure, severe myelosuppression, cardiac disease (monitor during therapy initiation). To prevent injection site necrosis, rotate injection site and use aseptic technique. Increases in hepatic transaminases (particularly ALT) may occur, monitor prior to treatment and at months 1, 3, 6 and periodically thereafter; if ALTq5xULN consider dose reduction. May cause severe liver injury and dysfunction (discontinue). Prior to inj. and for 24 hrs after, an antipyretic analgesic is advised to decrease flu-like symptoms. Evaluate patients at least every 2nd year. Driving/operating machinery. C Drugs with a narrow therapeutic index metabolised by cytochrome P450 (e.g. antiepileptics and some classes of antidepressants). A Flu-like symptoms, neutropenia, lymphopenia, leucopenia, thrombocytopenia, anaemia, asymptomatic transaminase increase, headache, injection site reactions (incl. pain and inflammation). Depression, insomnia, GI upset, pruritus, rash (incl. erythematous and maculopapular), myalgia, arthralgia, fatigue, rigors, fever.
PARKINSON’S, ALZHEIMER’S or obstructive pulmonary disease, anaesthesia. Urinary outflow obstruction or patients recovering from bladder surgery (not recommended). Pregnancy. C Cholinomimetics (not recommended). Caution: Potent inhibitors of CYP2D6 (eg. quinidine, paroxetine, fluoxetine) or CYP3A4 (eg. ketoconazole, ritonavir), drugs reducing heart rate (eg. digoxin, b-blockers, certain Ca++-channel blockers, amiodarone), drugs likely to cause torsades de pointes. A Rhinitis, anorexia, weight decrease, insomnia, confusion, depression, dizziness, somnolence, tremor, GI disorders, dyspepsia, UTIs, fever, headache, malaise, fatigue, fall, injury.
AND
MS 3.7
RILUTEK
sanofi-aventis
2NT
Antiglutamate. Riluzole 50mg. White cap.-shaped film-ctd tab. marked RPR 202. 56, A335.21. S Amyotrophic lateral sclerosis (motor neurone disease). P 50mg every 12 hrs. Q Not recommended. D Hepatic disease or baseline transaminase q 3x ULN. Pregnancy, lactation. B Initiate treatment under specialist supervision. Risk of hepatitis: monitor ALT before and during treatment, discontinue if 5x ULN. Renal impairment. Neutropenia. C Metabolised via CYP 1A2. REQUIP GSK A Abnormal liver function tests, GI disorders, asthenia, pain, headache, dizziness, 2MO tachycardia, somnolence, oral paraesthesia, Dopamine agonist. Ropinirole (as HCl) 0.25mg, neutropenia. 1mg, 2mg, 5mg. White, green, pink and blue pentagonal film-ctd tabs. 0.25mg-210, A43.52; SINEMET MSD 1mg-84, A51.29; 2mg-84, A102.55; 5mg-84, 2MO A205.11. Dopamine precursor/dopa decarboxylase inhibitor. P Week 1: 0.25mg three times daily with Carbidopa/levodopa 12.5mg/50mg, 10mg/100mg, meals. Week 2: 0.5mg three times daily. Week 3: 25mg/100mg (’Plus’), 25mg/250mg. Yellow, dapple0.75mg three times daily. Week 4: 1mg three blue, yellow, light-dapple-blue, oval scored tabs times daily. If necessary, continue to titrate in weekly increments of up to 3mg daily. Max. 24mg marked 520, 647, 650, 654 resp. Scoreline only to facilitate breaking, not for dosing. 12.5/50-90, REMINYL XL Shire daily. As adjunct to l-dopa, l-dopa dose may be A8.60; 10/100-90, A8.99; ’Plus’-90, A13.27; 25/250reduced gradually by around 20%. 90, A18.81. 2NO 2MO S Idiopathic, post-encephalitic and Antidementia drug. Galantamine (hydrobromide) ALSO REQUIP MODUTAB Ropinirole 2mg, 4mg, arteriosclerotic Parkinsonism. 8mg, 16mg, 24mg. White, pink and caramel 8mg. Pink, light brown or red resp. cap-shaped, P Patients not receiving levodopa: Plus, opaque hard caps. marked G8, G16 and G24 resp. film-ctd, prolonged-release tab., marked GS one 12.5/50, 10/100; initially 1 tab. three (Plus) to four 8mg-28, A64.97; 16mg-28, A80.69; 24mg-28, side and either 3V2, WXG or 5CC resp. on the times daily increased by 1 tab. every day or every A99.72. other. 2mg-84, A106; 4mg-84, A192.33; 8mg-84, other day up to max. 8 daily. 25/250; initially v S Symptomatic treatment of mild to A375.78. tab. once or twice daily; if necessary, add v tab. moderately severe dementia of the Alzheimer S Parkinson’s disease, as initial every day or every other day. See SPC. type. monotherapy in order to delay the introduction of Q Under 18 years, not recommended. P Initially 8mg once-daily in the morning l-dopa, or in combination with l-dopa when the 2MO preferably with food for 4 weeks. Initial effect of l-dopa wears off or fluctuates. ALSO SINEMET CR PROLONGED RELEASE maintenance dose, 16mg/day for at least 4 weeks. P Week 1: 2mg once daily. Week 2: 4mg Levodopa 200mg, carbidopa (as monohydrate) Consider increase to maintenance dose of 24mg/ once daily. If sufficient symptomatic control not 50mg. Mottled peach oval cont.-release tab. day. Moderate hepatic impairment: Initially 8mg achieved or maintained, increase to 8mg/day by marked DPP 521. 60, A26.48. once every other day for 1 week; thereafter 8mg 2mg weekly or longer intervals. May be increased 2 M O once-daily for 4 weeks; max. 16mg daily. to max 24mg/day if 8mg/day still not sufficient. ALSO HALF SINEMET CR PROLONGED RELEASE Q Not recommended. See SPC when switching from immediate-release Levodopa 100mg, carbidopa (as monohydrate) 2NO ropinirole tablets. As adjunct to l-dopa, l-dopa 25mg. Pink oval cont.-release tab. marked DPP ALSO REMINYL Galantamine (hydrobromide) 8mg, dose may be reduced gradually by approx. 30%. and 601. 60, A22.36. 12mg. Off-white, pink and orange-brown tabs. R Consider slower titration during P Over 18 years, patients not receiving marked JANSSEN one side and G8 or G12 on treatment initiation. levodopa, initially 1 CR tab. twice daily. Titrate reverse. 8mg-56, A80.69; 12mg-56, A99.72; 12mg- Q Under 18 years, not recommended. according to response. Patients receiving 168, A299.17. D Severe renal or hepatic impairment. levodopa, see SPC. P Starting dose 4mg twice a day morning Pregnancy, lactation. Q Not recommended and evening for four weeks. Initial maintenance B Severe CVD in particular coronary D Narrow angle glaucoma, history of dose 8mg twice a day for at least 4 weeks; insufficiency. Monitor BP, particularly at start of malignant melanoma. Lactation. consider increase to maintenance dose of 12mg treatment (risk of postural hypotension). B Cardiovascular, hepatic, renal, twice a day after assessment. If this increase Psychiatric or psychotic disorders (only if benefit inefficient or not tolerated, reduce dose to 16mg outweighs risk). Sudden onset of sleep may occur pulmonary or endocrine disease. Psychoses. Peptic ulceration. Wide angle glaucoma. Pregnancy. daily. Continue maintenance therapy as long as (warn patients). Driving/ operating machines. Monitor blood values and hepatic, renal and therapeutic benefit exists. Moderate hepatic Impulse control disorders may occur. Withdraw impairment: Initially 4mg once daily in the gradually over 1 week. Contains lactose. Contains cardiovascular function. C Drugs affecting central amines. MAOIs. morning for 1 week followed by 4mg twice daily sunset yellow (4mg-modutab only). for 4 weeks; max. 8mg twice daily. C Avoid: Neuroleptics and other centrally Antihypertensives and sympathomimetics. A Nausea, vomiting, anorexia. Postural Q Not recommended. active dopamine antagonists (sulpiride, hypotension. Involuntary movements. Cardiac and 2NO metoclopramide). Adjust ropinirole dose: CNS disturbances. Urine discolouration. ALSO REMINYL ORAL SOLUTION Galantamine Concomitant CYP1A2 inhibitors (ciprofloxacin, 4mg/ml. 100ml, A91.67. enoxacin, fluvoxamine), if HRT is introduced or STALEVO Orion P As per Reminyl. stopped during treatment or if patients start or 2MO D Severe hepatic or severe renal stop smoking. Dopamine precursor/dopa decarboxylase inhibitor/ impairment. Lactation. A Somnolence, syncope, nausea, COMT inhibitor. Levodopa/carbidopa/entacapone: B Sick sinus syndrome, other hallucinations, dizziness (incl. vertigo), confusion 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, supraventricular cardiac conduction disturbances, (in adjunct therapy), vomiting, heartburn, history of ulcer disease, history of severe asthma abdominal pain, constipation, oedema peripheral. 125/31.25/200mg, 150/37.5/200mg, 200/50/200mg. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
131
3.8 ADHD,
CNS
NARCOLEPSY Complex (NMS) and /or rhabdomyolysis or hyperthermia, phaeochromocytoma. Pregnancy, lactation. B Check liver function before treatment and every 2 weeks for 1st year, every 4 weeks for next 6 months and every 8 weeks thereafter. Changes in dose should be preceded by liver enzyme testing and then monitoring to commence following sequence above. Discontinued if ALT and/or ASTqULN or if signs of hepatic failure. Severe renal impairment. Contains lactose. C Consider levodopa dose reduction. Non selective MAOIs (contraindicated). Caution: Selective MAO-B inhibitors, benserazide, warfarin, potent NA uptake inhibitors. A GI disorders, dyskinesia, syncope, orthostatic complains, sleep disorders, somnolence, hallucination.
to max. 54mg daily. New patients, limited experience, start 18mg daily. Patients taking methylphenidate 3 times daily formulations: 18mg 3 x 5mg; 36mg 3 x 10mg; 54mg 3 x 15mg. Swallow whole with liquid. D Marked anxiety and tension; glaucoma; family history or diagnosis of Tourette’s syndrome; in combination with non-selective irreversible MAOIs (and within 14 days of their discontinuation); hyperthyroidism; severe angina pectoris; cardiac arrhythmias; severe hypertension; severe depression, anorexia nervosa, psychotic symptoms or suicidal tendency; known drug dependence or alcoholism. Pregnancy, lactation. B Not recommended: Known structural cardiac abnormalities, pre-existing severe GI narrowing (pathologic or iatrogenic), dysphagia, significant difficulty in swallowing tabs. Caution: Hypertension (monitor BP), underlying medical TYSABRI Biogen conditions that might be compromised by BP and heart rate increases, psychotic patients. Evaluate 2J Selective adhesion-molecule inhibitor. Natalizumab for tics. do not use to prevent or treat normal fatigue states. Care with withdrawal after chronic 20mg/ml. Concentrate for soln for inf. use. May lower seizure threshold, discontinue if S Single disease modifying therapy in highly active relapsing remitting multiple sclerosis seizures. Monitor for emergence or worsening of (MS) for patients with high disease activity despite aggressive behaviour. FBC, differential and platelet counts advised during prolonged use. treatment with a b-interferon and patients with Visual disturbances may occur. Monitor long-term rapidly evolving severe relapsing remitting MS. patients for weight and/or height. Effective P 300mg by iv. inf. once every 4 weeks. contraception required in females post-menarche. Admin. over 1 hour, monitor patients during inf. Contains lactose. and for up to 1 hour after. Reconsider continued C Contra: MAOIs. Caution: Vasopressor therapy if no evidence of therapeutic benefit agents, coumarin anticoagulants, anticonvulsants beyond 6 months. (e.g. Phenobarbital, phenytoin, primidone), some Q Under 18 years, contraindicated. antidepressans (tricyclics, SSRIs). Halogenated D Progressive Multifocal anaesthetics. Avoid alcohol. Leukoencephalopathy (PML). Patients with A Nasopharyngitis, aggression, anxiety, increased risk for opportunistic infections, affect lability, tic, insomnia, headache, dizziness, including immunocompromised patients. Known cough, pharyngolaryngeal pain, GI disorders, active malignancies (except cutaneous basal cell irritability, pyrexia, decreased weight. carcinoma). Children and adolescents. Pregnancy (unless clearly necessary), lactation. EQUASYM Shire B Risk of PML. Before initiation recent 0LO MRI (within 3 mths) should be available and CNS stimulant. Methylphenidate (HCl) 5mg, 10mg, monitor patients regularly thereafter for 20mg. Tab. with breakline, with Medeva and neurological signs/symptoms of PML. Other strength embossed on one side. 5mg-30, A3.50; opportunistic infections may occur. If either of 10mg-30, A6.39; 20mg-30, A12.77. these conditions suspected discontinue and only 0 LO resume when excluded. Risk of hypersensitivity reactions (including serious systemic reactions); ALSO EQUASYM XL Methylphenidate (HCl) 10mg, discontinue if occur. Inform patients of risks 20mg, 30mg. Modified release opaque caps. Dark involved and give patients the special alert card. green/white, blue/white, reddish-brown/white Pharmacodynamic effects last for 12 weeks resp. marked with Celltech 574, Celltech 575 or TASMAR Meda following the last dose. Antibodies against Celltech 576 on cap and 10mg, 20mg or 30mg on 2NO natalizumab may develop. body. 10mg-30, A31.92; 20mg-30, A38.28; 30mgC Contra: b-interferons, glatiramer COMT inhibitor. Tolcapone 100mg. Light yellow, 30, A44.67. acetate, immunosuppressive and antineoplastic hexagonal, biconvex, film-ctd tab. marked S Attention-deficit hyperactivity disorder therapies. TASMAR and 100. 100, A116.17. where remedial measures prove insufficient. A UTIs, nasopharyngitis, urticaria, S In combination with levodopa/ Q Over 6 years: Initially, 5mg once or headache, dizziness, vomiting, nausea, arthralgia, benserazide or levodopa/carbidopa for use in twice daily, increasing if necessary by weekly rigors, pyrexia, fatigue. patients with levodopa-responsive idiopathic increments of 5-10mg in daily dose. Admin daily Parkinson’s disease and motor fluctuations, who dose of Equasym in divided doses. 10mg once 3.8 ADHD, NARCOLEPSY failed to respond to or are intolerant of other daily may be used in place of Equasym 5mg twice COMT inhibitors. daily from the beginning of treatment where CONCERTA XL Janssen-Cilag P 100mg three times daily. Take 1st dose appropriate. Patients established on an immediate 0LNO with 1st levodopa dose, and subsequent doses 6 release methylphenidate may be switched to and 12 hrs later. May be exceptionally increased CNS stimulant. Methylphenidate (HCl) 18mg, equivalent daily dose of Equasym XL. Max: 60mg to 200mg three times daily if benefit outweighs 27mg, 36mg. 18mg-30, A37.43; 27mg-30, A45.06; daily. Swallow cap. whole with liquid, or open hepatic risk. Discontinue if substantial benefits are 36mg-30, A50.94. cap. and swallow contents immediately after not seen within 3 weeks. S Attention Deficit Hyperactivity Disorder sprinkling on soft food, followed by a drink. Q Not recommended. (ADHD) when remedial measures alone Discontinue periodically to assess child’s condition. D Because of risk of potentially fatal, insufficient. Under 6 years, not indicated. acute liver injury, should not be considered as P Not applicable. D Marked anxiety, agitation or tension. first-line adjunct therapy. Liver disease or Q Under 6 years, not recommended; over Current or history of drug dependence, increased liver enzymes, severe dyskinesia, history 6 years, dosage should be individualised. Once alcoholism, severe depression, schizophrenic symptoms, psychopathological personality of Neuroleptic Malignant Syndrome Symptom daily in the morning, increasing weekly by 18mg
Film-ctd tabs. Resp., round greyish/brownish-red, oval light brownish red, oval greyish/brownish-red, oval light brownish red, ellipse-shaped greyish/ brownish-red and oval dark brownish-red; all marked LCE followed with levodopa strength. All strengths-100, A103.00. S Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/ dopa decarboxylase inhibitor treatment. P Adjust dose as required. Max: 10 tabs. daily for all strengths except 200/50/200 (max 7 tabs.). Hepatic impairment, may need dose reduction. See SPC. Q Under 18 years, not recommended. D Severe hepatic impairment, pheochromocytoma, narrow-angle glaucoma, previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis. Non-selective MAOIs (e.g. phenelzine, tranylcypromine). Concomitant use of selective MAO-A and MAO-B inhibitors. Pregnancy, lactation. B Severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, history of peptic ulcer or of convulsions, past or current psychosis. History of MI (monitor cardiac function). Monitor mental changes, depression with suicidal tendencies, and other serious antisocial behaviour. Past or current psychosis. Wide-angle glaucoma (control intraocular pressure). May induce orthostatic hypotension. Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy. Driving or operating machines. Avoid abrupt dosage reduction. Monitor for weight loss. Pathological gambling and increased libido have been reported. Not for treatment of drug-induced extrapyramidal reactions. Contains sucrose. C Caution: Antihypertensives, antidepressants, D2 receptor antagonists, phenytoin, iron, papaverine, warfarin, high protein diet. A Dyskinesias, nausea, diarrhoea, mental changes (paranoid ideation, psychotic episodes, depression, with or without development of suicidal tendencies,cognitive dysfunction), Parkinsonism aggravated, dizziness, dystonia, hyperkinesia, GI upset, urine discolouration, fatigue, increased sweating, falls, insomnia, hallucinations, confusion, paroniria.
132
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA structure, aggression, or suicidal tendency. Heart failure, MI, severe hypertension, hyperthyroidism, severe angina pectoris, cardiac arrhythmia, glaucoma, thyrotoxicosis. B Use in psychotic children. Can lead to marked tolerance, psychological dependence. Monitor: Growth, BP, long-term use. Caution: Anorexia, emotionally unstable patients, epileptics, withdrawal. May exacerbate tics and Tourette’s syndrome. Contains sucrose. Driving or using machinery. Pregnancy (unless clearly necessary), lactation. C Contra: MAOIs (or within 2 weeks). Alcohol (avoid). Reduce dosage: Coumarin anticoagulants, some anticonvulsants, TCAs, SSRIs. Caution: Vasopressor agents, clonidine or other centrally acting a-2 agonists, haloperidol, thioridazine, guanethidine. Halogenated anaesthetics. A Nervousness, insomnia, decreased appetite, arrhythmia, palpitations, tachycardia, abdominal pain, nausea, vomiting, dry mouth, changes in BP and heart rate, arthralgia, dizziness, drowsiness, dyskinesia, headache, hyperactivity, abnormal behaviour, aggression, agitation, anorexia, anxiety, depression, irritability, alopecia, pruritus, rash, urticaria.
PAIN, Under 6 years, not indicated.
0LO
ALSO RITALIN LA Methylphenidate (HCl) 20mg, 30mg, 40mg; prolonged-release. White to offwhite beads in white, yellow or light brown opaque hard gelatin cap. with imprint R20, R30, R40 (body) resp. and NVR (cap). 20mg-30, A33.59; 30mg-30, A45.95; 40mg-A57.03. P Not applicable. Q 6 years and over: Once daily in morning, with daily dose similar to short-acting methylphenidate daily dose (cf. Ritalin tabs. for initial dose). Max. daily dose: 40mg. Swallow as whole cap. or sprinkle entire cap. content on food. Under 6 years, not recommended. D Anxiety, agitation or tension. Motor tics in patient or sibblings, family history or diagnosis of Tourette’s syndrome. Hyperthyroidism, severe angina pectoris, cardiac arrhythmias, glaucoma, thyrotoxicosis. Lactation, pregnancy. B History of drug dependance, epilepsy. Monitor BP and growth. Behavioural disturbance and thought disorder (psychotic children). Driving or operating machinery. Potential marked tolerance, psychological dependence, psychotic episodes (chronic abuse). Monitor long-term therapy. Withdrawal. C Alcohol (avoid). Reduce dosage: PROVIGIL Cephalon Coumarin anticoagulants, anticonvulsants (phenobarbitone, phenytoin, primidone), 0NO phenylbutazone, tricyclic antidepressants. Caution: Non-amphetamine wake promoter. Modafinil Pressor agents, MAOIs. Guanethidine (reduce 100mg, 200mg. White to off-white tabs. debossed antihypertensive effect). with 100 or 200 on one side. 100mg-30, A75.55; A Slight growth retardation. Transient 200mg-30, A148.16. decreased appetite, nervousness, insomnia, S Excessive sleepiness associated with headache, dizziness, dyskinesia. GI disturbances. chronic pathological conditions incl. narcolepsy, Cardiovascular disorders (tachycardia, palpitations, obstructive sleep apnoea/hypopnoea syndrome change in BP). Rash, pruritus, urticaria, fever, and moderate/severe chronic shift work sleep arthralgia, hair loss. disorder.
PYREXIA
4.1
abnormalities, patients susceptible to hypotension, history of QT prolongation, history of seizure. Monitor BP and pulse, growth and development, cognition and sexual maturation (long-term therapy). Allergic events. Jaundice (discontinue). Monitor for suicide-related behaviour, hostility, emotional lability, psychotic/manic symptoms. C Contra: MAOIs (min. 2 weeks apart). Caution: High dose (nebulised or systemic) salbutamol (or other b2 agonists), QT prolonging drugs, drugs causing electrolyte imbalance, CYP2D6 inhibitors, drugs lowering seizure threshold, pressor agents, drugs affecting NA. A Decreased appetite and weight, GI disorders, anorexia, influenza, early morning awakening, irritability, mood swings, dizziness, somnolence, mydriasis, dyspepsia, nausea, skin disorders, fatigue. Adults: GI disorders, insomnia.
XYREM
UCB
2MT
CNS depressant. Na+ oxybate 500mg. Clear to slightly opalescent oral soln. 180ml, A384.20. S Narcolepsy with cataplexy in adults. P Initially 4.5g/day in 2 equal doses. Dilute each dose with 60ml water. Titrate according to response up or down in increments of 1.5g/day to a max. of 9g/day in 2 equal doses. Min. 2 weeks between increments. Take 1st dose at bedtime 2-3 hours after eating and 2nd 2.5-4 hours later. If stopped for 14 days, restart at lowest dose. Hepatic impairment: 1/2 starting dose. Q Not recommended. D Patients with succinic semialdehyde dehydrogenase deficiency. B May induce respiratory depression. Monitor for dependence, depressive symptoms. Investigate if urinary/faecal incontinence occurs. Risk of sleepwalking. Caution: Patients with porphyria, compromised liver function, P Obstructive sleep apnoea/Narcolepsy: STRATTERA Lilly discontinuation, elderly. Epilepsy, not 200mg-400mg daily in two divided doses (morning 2 M O recommended. Contains Na+. Pregnancy, lactation; and noon), or as a single dose in the morning. not recommended. Driving or using machines NA reuptake inhibitor. Atomoxetine (HCl) 10mg, Shift work sleep disorder: 200mg daily as single (wait r 6 hours). 18mg, 25mg, 40mg, 60mg. Opaque caps. White, dose 1 hour prior to shift. C Contra: Opoids, barbiturates. Avoid: gold/white, blue/white, blue and blue/gold, R Over 65 years, initially 100mg daily. Alcohol, benzodiazepines. Sedative hypnotics or brown/white resp. marked strength and Lilly Max. 400mg daily. followed by number. 7 day pack: 10mg and 25mg, other CNS depressants. GHB dehydrogenase Q Not recommended. A19.69; 28 day pack: 10mg, 18mg, 25mg, 40mg, stimulants or inhibititors (e.g. valproate, phenytoin D Pregnancy, lactation, uncontrolled or ethosuximide). TCAs. and 60mg, A77.68. hypertension, or arrhythmia. A Hypersensitivity, anorexia, sleep S Attention-Deficit/Hyperactivity Disorder B Monitor BP and heart rate in disorders, abnormal thinking, confusion, (ADHD) in children of 6 years and older and in hypertensive patients. History of LV hypertrophy or ischaemic ECG changes, chest pain, arrhythmias adolescents as part of a comprehensive treatment depression, hallucination, agitation, dizziness, headache, sleep paralysis, somnolence, tremor, programme. or other significant manifestations of mitral valve amnesia, blurred vision, GI disorders, sweating, P Start of treatment not recommended. prolapse in association with CNS stimulant use. Q Under 6 years, not recommended. Up to rash, muscle cramps, enuresis nocturna, asthenia, C Oral contraceptives, TCADs, fatigue, feeling drunk, increased BP. 70kg body weight: Initially, 0.5mg/kg as single anticonvulsants, warfarin. daily dose in the morning. Maintenance, approx. A Nervousness, anxiety, headache, 4.1 PAIN, PYREXIA 1.2mg/kg/day. Max. 1.8mg/kg/day. Over 70kg: insomnia, abdominal pain, nausea, dry mouth, Initial daily dose, 40mg. Maintenance, 80mg daily. tachycardia, palpitation, asthenia, chest pain, ABSTRAL Fannin Max. 100mg daily. Maintain initial dose up to 7 blurred vision, abnormal liver function tests. days before upward dose titration. In some cases, 0 L O Opioid. Fentanyl (as citrate) 50mcg, 100mcg, RITALIN Novartis consider treatment into adulthood. Some may 200mcg, 300mcg, 400mcg, 600mcg, 800mcg. White benefit from twice daily treatment in evenly 0LO divided doses. Stop abruptly in cases of significant sublingual tabs. Pentagon, round, oval, triangle, CNS stimulant. Methylphenidate (HCl) 10mg. diamond, D and caps. shaped, resp. All strenghs: adverse effects; otherwise discontinue gradually. White, circular, flat scored tabs. marked CG one 10, A59.74; 30, A175.63. Treatment q 1 year; re-evaluation of therapy by A side, AB on reverse. 30, 5.40. S Breakthrough pain in patients using an ADHD specialist recommended. Hepatic S Attention-deficit hyperactivity disorder opioid therapy for chronic cancer pain. insufficiency: v dose (if moderate); t dose (if where remedial measures prove insufficient. P Initially, 100mcg; titrating upwards as severe). Patients with a known poor metaboliser P Not applicable. genotype: Consider lower starting dose and slower necessary through the range of available dosage strengths (see SPC). Maintain established Q Over 6 years: Initially, 5mg once or up titration of dose. appropriate dose with max. 4 doses/day. twice daily, increasing if necessary by weekly D Narrow angle glaucoma. Lactation, Q Under 18 years, not recommended. increments of 5-10mg in daily dose. Max: 40mg pregnancy (unless benefit outweighs risk). daily. Administer total daily dose in divided doses. B Caution: Hypertension, tachycardia, CVD D Opioid-naive patients. Severe respiratory depression, severe obstructive lung conditions. Discontinue periodically to assess child’s condition. or cerebrovascular disease, structural cardiac AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
133
4.1 PAIN,
ANALGESIA
PYREXIA
Lactation, pregnancy (unless clearly necessary). B Caution: COPD , myasthenia gravis, susceptibility to intracranial effects of hyperkapnia (e.g. raised intracranial pressure, reduced consciousness, coma, brain tumours), head injury (avoid), bradyarrhythmias, hypovolaemia, hypotension, mouth wounds or mucositis. Kidney or liver dysfunction, elderly, cachectic/ debilitated patients; monitor for signs of fentanyl toxicity. Driving/using machines. C Caution: CYP3A4 inhibitors (see Appendix I), other CNS depressants (eg. morphine derivatives, general anaesthetics, skeletal muscle relaxants, sedative antidepressants, sedative H1 antihistamines, barbiturates, anxiolytics, hypnotics, antipsychotics, clonidine). Not recommended: Alcohol, MAOIs (within 14 days), partial opioid agonists/antagonists. A Dizziness, somnolence, headache, fatigue. Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis, vision abnormal, respiratory depression, rhinitis, pharyngitis, GI disorders, Rash, pruritus, orthostatic hypotension, flushing, hot flush, asthenia, application site irritation, depression, anorexia, concentration impaired, euphoria.
Benzoxazocine. Nefopam (HCl) 30mg. White filmctd tab. marked APN. 90, A13.68. S Acute pain, incl. post-operative, dental, cancer and musculo-skeletal pain. P 1-3 three times daily. Q Not recommended. D History of convulsive disorders. MI. B Hepatic or renal insufficiency, urinary retention. Pregnancy. C MAOIs, anticholinergics, sympathomimetics, tricyclics. A Nausea, nervousness, dry mouth, dizziness, hypotension, syncope, palpitations, paraesthesia, convulsions, tremor, confusion, hallucinations, angiodema, allergic reactions.
ADVIL LIQUIGELS 2K
ANADIN PARACETAMOL Wyeth Healthcare
2K
Analgesic. Paracetamol 500mg. White cap. shaped film-ctd scored tab. marked Anadin-P. 12, A1.24. S Analgesic and antipyretic. P 2 four hourly; max. 8 in twenty four hours. Q Under 6 years, not recommended; 6-12 years, 1 four hourly; max. 4 in twenty four hours. Wyeth Healthcare B Renal and hepatic impairment.
NSAID. Ibuprofen 200mg. Green translucent, oval soft gelatin cap. marked Advil one side in white ink. 20, A3.20. S Mild to moderate pain (rheumatic/ muscular pain, backache, headache, dental pain, dysmenorrhoea), feverishness, cold and flu symptoms. P 1-2 caps. every 4-6 hours. Max. 6 in 24 ACTIQ Cephalon hours. Q Under 12 years, not recommended. 0LO D Aspirin/NSAID induced allergies. Peptic Opioid agonist. Fentanyl 200mcg, 400mcg, ulcer, other GI disorders. Pregnancy (1st and 3rd 600mcg, 800mcg, 1200mcg, 1600mcg. Compressed trimester). lozenges with oromucosal applicator. 3 units, B Asthma, cardiac/renal/hepatic A27.51; 30 units, A275.15. insufficiency. Elderly. S Management of breakthrough pain C Other analgesics. Caution: Oral(BTP) in patients already receiving maintenance anticoagulants, thiazide diuretics. opioid therapy for chronic cancer pain. BTP is a A GI disturbances. Rash, pruritus. Easy transitory exacerbation of pain that occurs on a bruising or bleeding. Abnormal liver function background of otherwise controlled persistent tests. pain. P For oromuccosal admin. unit placed ANADIN Wyeth Healthcare against the cheek and moved around the mouth 2K for max. mucosal exposure. Initially 200mcg, Salicylate/xanthine. Aspirin 325mg, caffeine 15mg, titrated upwards through 200, 400, 600, 800, 1200, quinine sulphate 1mg. White film ctd tab. marked 1600mcg as necessary. Each unit should be ANADIN. 12, A1.03; 24, A1.96. consumed over 15 mins. and individually titrated S Pain of headache, neuralgia, rheumatic to a ’successful’ dose. Monitor patients until a pain, period pain, dental pain, toothache. ’successful’ dose is reached. During treatment a Common cold. second unit of the same strength may be P 2 three to four hourly as required. Max. consumed. Max. 2 units per episode and 4 units 12 in 24 hours. per day. See SPC. Q Under 16 years, not recommended. Q Under 18 years, not recommended. 2K D MAOIs or within two weeks of use. ALSO ANADIN EXTRA Aspirin 300mg, paracetamol Severe respiratory depression, severe obstructive 200mg, caffeine 45mg. White film ctd scored tab. lung conditions. Hypersensitivity. with a break bar on one side and A and E B Tolerance/dependence may develop. embossed on reverse. 24, A2.74. respiratory depression, COPD, head injury, S Headache, neuralgia, myalgia, increased intracranial pressure or impaired rheumatism, toothache, dysmenorrhoea, common consciousness. Bradyarrhythmias, hepatic or renal cold or flu. impairment, hypovolaemia, hypotension. Oral hygiene recommended to avoid potential harm to P 1-2 four hourly. Max. 6 in 24 hours. Q Under 16 years, not recommended. teeth. Pregnancy, lactation. 2K C CYP3A4 inhibitors such as macrolide antibiotics eg erythromycin, ketoconazole; certain ALSO ANADIN MAXIMUM STRENGTH Aspirin 500mg, caffeine 32mg. Yellow/green cap. marked protease inhibitors eg ritonavir; grapefruit juice, Anadin 500 both sides. 12, A1.35. other CNS depressants incl. other opioids, sedatives, hypnotics, general anaesthetics, S Headaches, neuralgia, rheumatic, period phenothiazines, tranquillisers, skeletal muscle and dental pain, colds and flu. relaxants, sedating antihistamines, alcohol. P 1 three to four hourly; max. 8 in 24 A Nausea, vomiting, constipation, hours. dyspepsia, asthenia, headache, anxiety, confusion, Q Under 16 years, not recommended. dizziness, dry mouth, insomnia, somnolence, D Peptic ulceration, bleeding disorders. dyspnoea, pruritus, sweating, abnormal vision. Late pregnancy, lactation. B IBD, coagulation disorders, asthma. ACUPAN Meda Prolonged use. Elderly. Renal, cardiac or hepatic 2NO impairment.
134
C Warfarin, heparin. Caution: As with other NSAIDs. A Hypersensitivity reactions, asthma, renal urate calculi formation, bleeding and tinnitus. GI disorders or ulceration.
BENYLIN DAY AND NIGHT McNeil Healthcare
0 Sympathomimetic/antihistamine/analgesic. Pseudoephedrine (HCl) 60mg and paracetamol 500mg (day tabs); diphenhydramine (HCl) 25mg and paracetamol 500mg (night tabs). Day tabs: White, oblong, marked A7C on both sides of score. Night tabs: Blue, round. All biconvex. 12 day tabs + 4 night tabs, A5.19. S Relief of symptoms associated with cold and influenza. P 1 white day tab. every 4-6 hours (morning, midday, afternoon); max. 3 in 24 hours. 1 blue tab. at night. Q Under 12 years, not recommended. D Severe hypertension or coronary heart disease. B Mild to moderate hypertension, heart disease, diabetes mellitus, hyperthyroidism, elevated intraocular pressure and prostatic enlargement. Severe hepatic impairment, moderate/severe renal impairment. Driving/ operating machines. C MAOIs (contra). Caution: Alcohol, other CNS depressants, anticholinergics, TCAs, sympathomimetics, bretylium bethanide, guanethidine, debrisoquine, methyldopa, a- and badrenergic blockers, anticonvulsants, oral contraceptives, metoclopramide, domperidone, cholestyramine, warfarin, other coumarins. A Drowsiness, dizziness, blurred vision, GI disturbances, dry mouth, nose and throat, urinary retention.
BIODOL
Niche
2MO Opiate analogue. Tramadol (HCl) 50mg. Olive and yellow hard capsule containing a white powder. 100, A11.54. S Management (treatment and prevention) of severe pain. P Acute pain: 100mg initially, followed by doses of 50-100mg every 4 hours. Chronic pain: 50mg initially; titrate according to severity. Max. 400mg per day. R As for adult dose. Q Under 12 years, not recommended. D Acute intoxication. B History of epilepsy, seizures. Head injury, increased intracranial pressure, shock. Hepatic or renal insufficiency. Respiratory depression. Anaesthesia. C Alcohol, centrally acting drugs, MAOIs, carbamazepine, lithium. SSRIs and TCAs (may increase potential).
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA
PAIN,
anaesthetics, benzodiazepines, other CNS depressants. A Headache, dizziness, somnolence, dry mouth, GI disorders, skin disorders, anorexia, confusion, depression, insomnia, nervousness, BRUFEN RETARD Abbott anxiety, vasodilation, dyspnoea, tiredness, asthenia, pain, oedema, appl. site reaction. 2MO NSAID. Ibuprofen 800mg. White pillow-shaped, Ergha film-ctd sust.-release tab. marked BRUFEN RETARD. BY-MADOL 2MO 56, A13.89. S Mild to moderate pain. Dental and post Opiate analogue. Tramadol HCl 50mg. Yellow/ operative pain. Dysmenorrhoea. green cap. marked TRA50. 100, A7.55. P 2 as a single dose, preferably in the S Management of severe pain. early evening, swallowed whole with plenty of P 50-100mg three or four times daily, fluid. In severe or acute conditions, max. 3 daily in max. 400mg daily. two divided doses. Q Under 12 years, not recommended; over Q Under 12 years, not recommended. 12 years, as per adults.
A Nausea, vomiting. Dry mouth, constipation (rare). Drowsiness, fatigue, dizziness, headache. Rarely cardiovascular effects, rash, GI irritation. Urinary retention.
2MO
2MO
ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta sug-ctd tab. marked BRUFEN 400; magenta oval film-ctd tab. marked BRUFEN 600. 400mg-250, A6.87; 600mg-100, A4.37.
ALSO BY-MADOL SR Tramadol HCI 100mg, 150mg, 200mg. Prolonged-release hard cap. 100mg: Opaque yellow cap and natural transparent body; 150mg: Opaque yellow cap and body; 200mg: Opaque yellow cap and opaque white body. 100mg-60, A9.86; 150mg-60, A14.74; 200mg-60, A19.70. S For moderate to severe pain. P 100-200mg twice daily morning and evening. Adjust dose depending on the severity and sensitivity. Max. 400mg daily. Min. 8 hours between doses. R Elderly: Over 75 years, dosage intervals should be prolonged according to individual needs. Q Under 12 years, not recommended. D Uncontrolled epilepsy. Not for treatment of opioid dependence. ChildrenQ25kg. Pregnancy, lactation. Severe renal/hepatic insufficiency. B Impaired consciousness of unclear aetiology, shock; impaired respiratory function; increased intracranial pressure, head injury, brain disease, impaired liver/kidney function. History of epilepsy or those susceptible to convulsions, sensitivity to opiates. Contains sucrose, methyl/ propyl parahydroxybenzoate. Driving or operating machinery. C Contra: Acute intoxication with alcohol or other centrally acting drugs, MAOIs (or within 2 weeks of withdrawal). Caution: Carbamazepine, SSRIs, TCAs, anti-psychotics and other convulsion threshold-lowering drugs, coumarin derivatives, ondansetron. Use with agonists/antoganists (e.g. buprenorphine, nalbuphine, pentazocine), not recommended. A Nausea, vertigo, headaches, drowsiness, vomiting, constipation, dry mouth, sweating, fatigue, dependence.
2MO ALSO BRUFEN SYRUP Ibuprofen 100mg/5ml. 200ml, A1.90. S Reduction of fever in children. P 1200-1800mg daily in three divided doses. Max. 2400mg daily. Q 6 months-1 year, 2.5ml three times daily; 1-2 years, 2.5ml three or four times daily; 3-7 years, 5ml three or four times daily; 8-12years, 10ml three or four times daily. (Based on 20mg/kg body weight daily). Dosage should not exceed 500mg in twenty four hours for children weighing less than 30kg. D Active peptic ulcer. B Aspirin/anti-inflammatory induced allergy. Asthma. Pregnancy. C Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin, other NSAIDs, corticosteroids, anticoagulants, anti-platelet agents, SSRIs, quinolone antibiotics, probenacid, oral hypoglycaemics, Ginkgo biloba extracts. A Dyspepsia, GI bleeding, rash, rarely thrombocytopenia.
BUTRANS
Mundipharma
0LO Opiate. Buprenorphine 5mcg, 10mcg, 20mcg per hour. Transdermal patch. 5mcg/h-2, A13.05;10mcg/ h-4, A47.44; 20mcg/h-4, A86.40. S Severe opioid responsive pain conditions not adequately responding to non-opioid analgesics. P Admin. every 7th day. Initially, 5mcg/h applied to intact, hairless skin of upper outer arm, upper chest, upper back or side of chest; titrate after 3 days according to response. Do not reuse same site for 3-4 weeks. Q Under 18 years, not recommended. D Treatment of acute pain, opioid dependence and narcotic withdrawal. Severely impaired respiratory function, myasthenia gravis, delirium tremens. Pregnancy, lactation. B Hepatic insufficiency, fever, convulsive disorders, head injury, shock, reduced level of consciousness, intracranial lesions, increased intracranial pressure, analgesia, history of drug abuse; caution. Potential for significant respiratory depression, withdrawal symptoms. Driving /using machines. C Contra: MAOIs (2 weeks apart). Caution: CYP3A4 inhibitors or inducers, general
PYREXIA
4.1
A3.12. Q 1-6 years: 5-10 ml. 3 months-1 year: 2.55 ml. Both, repeat every 4 hours, if necessary; max. 4 doses per 24 hours. Under 3 months: 2.5 ml for post-vaccination fever at 2 months, followed if necessary by same dose 4 to 6 hours later; other, consult doctor.
2 ALSO CALPOL SIX PLUS Paracetamol 250mg/5ml. Susp. 70ml, A3.10; Sugar-free, 70ml, A3.10. P 10-20ml every four hours. Max. 80ml per day. Q Under 6 years, not recommended. 6-12 years, 5-10ml every four hours; max. 4 doses per day.
2 ALSO CALPOL FASTMELTS Paracetamol 250mg. Orodispersible tabs. 12, A2.04; 24, A3.30. P As for children over 12 years. Q Over 12 years: 2-4; 6-12 years: 1-2. Repeat every 4 hours; max. 4 doses per 24 hours. B Moderate to severe renal impairment, severe hepatic impairment. C Caution: Barbiturates, TCAs, alcohol, anticonvulsants, oral steroid contraceptives, metoclopramide, domperidone, cholestyramine, warfarin and other coumarins.
CAPRIN
Pinewood
2MO Salicylate. Aspirin 300mg. Pink ent-ctd tab. marked CAPRIN. 100, A3.72. S Analgesic and antipyretic. P 3 tabs (900mg) 3-4 times daily. Q Not recommended. D Active peptic ulceration, coagulation deficiency disorders, lactation. B Reye’s syndrome in children. Avoid: Stroke patients, severe hepatic/renal impairment, history of peptic ulceration or coagulation abnormalities, dehydration. Pregnancy (avoid at term). Elderly. C Hypoglycaemic agents (esp.sulphonylureas), uricosuric agents, methotrexate, antacids, antiepilectic agents (phenytoin & Na+ valproate), sulphonamides, antihypertensives, iron salts and alkali. A Allergic or asthmatic reactions. Bronchospasm.
CATAFLAM
Novartis
2MO
Phenylacetic acid. Diclofenac (K+) 25mg, 50mg. Circular, biconvex, sugar ctd tabs. 25mg pale red; 50mg reddish brown. 25mg-30, A1.14; 50mg-30, A2.21. S All grades of pain and inflammation incl. acute musculo-skeletal disorders, painful CALPOL SUSPENSION McNeil Healthcare conditions resulting from trauma, including low back pain, fracture, sprains, strains, orthopaedic, 2 dental and other minor surgery. Migraine, acute Analgesic. Paracetamol 120mg/5ml. Susp. 60ml, gout. Dysmenorrhoea. A2.17; 70ml, A2.40; 140ml, A4.29; Sachets: 12 x P 100-150mg in two or three divided 5ml, A3.12. doses. Max. 150mg daily. S Pain (incl. teething pain), antipyretic. Q Under 14 years, not recommended; over Q 6-12 years: 10-20 ml. 1-6 years: 5-10 ml. 14 years, 75-100mg in two or three divided doses. 3 months-1 year: 2.5-5 ml. Repeat every 4 hours, if D Active or suspected peptic ulcer. necessary; max. 4 doses per 24 hours. Under 3 Asthma, aspirin/anti-inflammatory induced allergy. months: 2.5 ml for post-vaccination fever at 2 B Renal, cardiac or hepatic impairment. months, followed if necessary by same dose 4 to 6 Elderly. Pregnancy, lactation. hours later; other, consult doctor. C Lithium, digoxin, anticoagulants, 2 antidiabetic agents, cyclosporin, methotrexate, ALSO CALPOL SUGAR-FREE Paracetamol 120mg/ quinolone antimicrobials, other NSAIDs, 5ml. 60ml, A2.17; 140ml, A4.29; Sachets: 12 x 5ml, corticosteroids, diuretics.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
135
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ANALGESIA Max. 120mg daily given in evenly divided doses. Evaluate response after 2 months; reassess at least every 3 months. Discontinue gradually over 1-2 CODANT Antigen weeks. Q Under 18 years, not recommended. 2NO D Liver disease resulting in hepatic Opiate. Codeine phos. 30mg. White tab. 100, impairment, severe renal impairment (ccQ30ml/ A9.73. min), uncontrolled hypertension. Pregnancy (unless S Mild to moderate pain. essential), lactation. P 1 four hourly as required. B History of mania, bipolar disorder, Q Not recommended. seizures, increased IOP or risk of acute narrowD Intestinal obstruction, Respiratory angle glaucoma. Hypertensive crisis reported. depression. Hypertension, cardiac disease; monitor BP at least B UC. Pregnancy. Codine may cause 1st month. Elderly. Suicidal thoughts; monitor constipation. Tolerance/dependence may occur carefully. May occur: Liver injury, incl. severe with repeated use. elevations of liver enzymes, hepatitis and jaundice. C Alcohol and other CNS depressants. Akathisia may develop. Driving/using machines. A Dizziness, sedation, constipation, Contains sucrose. nausea, pruritus. C Non-selective, irreversible MAOIs and CYCLIMORPH Amdipharm potent CYP1A2 inhibitors, eg. fluvoxamine, ciprofloxacin, or enoxacine (all contraindicated), 0LO other MAOIs (not recommended). Caution: Opiate/anti-emetic Cyclimorph 10: Morphine Anticoagulants, St John’s wort, warfarin, CYP2D6 tartrate 10mg, cyclizine tartrate 50mg. Cyclimorph substrates, other centrally acting and sedative 15: Morphine tartrate 15mg, cyclizine tartrate drugs, smoking. 50mg. Ampoules containing 1ml soln. for inj. A Weight decrease, palpitations, tremor, 10mg-5, A6.71, 15mg-5, A6.96. paraesthesia, blurred vision, tinnitus, yawning, GI S Moderate to severe pain where antidisorders, increased sweating, rash, musculoemesis is needed. skeletal pain, muscle tightness, muscle spasm, P 10-20 mg by SC, IM or IV inj.. Max. decreased appetite, flushing, fatigue, abdominal frequency: 4 hourly; not more than 3 doses/day. pain, erectile dysfunction, insomnia, agitation, R Reduce dose. decreased libido, anxiety, abnormal orgasm, Q 1-5 years, 2.5-5 mg; 6-12 years, 5-10mg. abnormal dreams. Both as max. single dose. Over 12 years, as for adults. DF 118 Galen D Respiratory depression, obstructed 2LO airways, excessive bronchial secretions. Attack of Opiate. Dihydrocodeine tartrate 30mg. White tab. bronchial asthma, HF secondary to chronic lung marked with tab. name. 100, A4.53; 500, A20.77. disease. Head injury or raised intra-cranial S Moderate to severe pain. pressure. Moderate or severe renal impairment. P 1 four to six hourly after meals. Severe hepatic impairment. Ulcerative colitis. Biliary and renal tract spasm, patients immediately Q Not recommended. D Respiratory depression, obstructive after operation of biliary tract. Acute alcohol intoxication, MAOIs (wait 14 days after stopping). airways disease. B Chronic hepatic disease. Renal Pregnancy, lactation (insufficient data). insufficiency. Allergy, hypothyroidism. Pregnancy. B Hypothyroidism, adrenocortical Elderly. insufficiency, hypopituitarism, myxoedema, prostatic hypertrophy, shock and diabetes mellitus, C Alcohol, CNS depressants, MAOIs. phaeochromocytoma, severe HF, glaucoma, A Constipation, nausea, headache, vertigo. obstructive disease of GI tract. Elderly, debilitated See SPC. patients. Driving or operating machine. Abrupt DIFENE Astellas withdrawal. C MAOIs. Phenothiazines, hypnotics, 2NO neuroleptics, alcohol, muscle relaxants (enhanced Phenylacetic acid. Diclofenac Na+ 25mg/ml. 3ml depressant effect). Anticholinergic drugs, amp. 10 x 3ml, A3.36. dexamphetamine, hydroxyzine, propranolol, S Acute back pain, post-operative pain, diuretics. renal colic. A Respiratory depression, raised intraP 75mg IM once or twice daily by deep cranial pressure, orthostatic hypotension, intragluteal inj. for max. 2 days. Post- operative drowsiness, confusion, dysphoria, restlessness, pain: Admin. 75mg IV diluted in 300ml normal miosis, constipation, nausea, vomiting, skin saline and inf. over min. 30 mins; a second dose reactions, biliary tract and renal spasm, vertigo, can be given 8 hrs later; max. 2 inf. in 24 hrs. dry mouth, nose and throat, blurred vision, Continue if necessary with tabs. or suppos. tachycardia, urinary retention, insomnia, auditory Q Not applicable. and visual hallucinations, cholestatic jaundice. D History of GI bleeding or perforation, related to previous NSAID therapy. Active, or CYMBALTA Lilly history of, recurrent peptic ulcer/haemorrhage. 2NO Aspirin/anti-inflammatory induced allergy. Severe 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, HF. In ulcerative or acute inflammatory conditions 60mg. Opaque caps. White body marked 30mg of the anus, rectum (proctitis) and sigmoid colon. with blue cap marked 9543; green body marked B Use lowest effective dose. Elderly. 60mg with blue cap marked 9542 resp. 30mg-28, History of GI disease/toxicity. Risk of GI bleeding, A 20.50; 60mg-28, A 34.15. ulceration or perforation. Risk of hypersensitivity S Diabetic peripheral neuropathic pain. reactions. May mask infection. Serious skin P Recommended dose, 60mg once daily. reactions have been reported rarely. Renal, cardiac A Epigastric pain, nausea, headache, dizziness, rash, elevation of liver enzymes.
PAIN,
PYREXIA
4.1
or hepatic impairment. Bleeding abnormalities. Long-term use. May impair female fertility; not recommended in women attempting to conceive. Pregnancy, lactation. C Lithium, digoxin, anticoagulants, antiplatelets, SSRIs, cyclosporin, methotrexate, quinolones, other NSAIDs and steroids, corticosteroid, diuretics, cardiac glycosides, antihypertensives, aminoglycosides, probenecid. A GI disorders, headache, dizziness, vertigo, rashes or skin eruptions, raised ALT, AST.
DISPRIN
Reckitt Benckiser
2K Salicylate. Aspirin 300mg. White soluble tab. marked with logo and DISPRIN one side. 12, A1.54; 24, A2.37. S Mild to moderate pain, pyrexia, headache, toothace, neuralgia, lumbago. P 1-2 in water four hourly. Max. 12 in twenty-four hours. Q Under 16 years, not recommended.
2K ALSO DISPRIN DIRECT Aspirin 300mg. Chewable tab. marked with logo. 24, A2.37. S Mild to moderate pain, pyrexia, lumbago. P 1-2 dissolved on tongue four hourly. Max. 12 in twenty-four hours. Q Under 16 years, not recommended.
2K ALSO DISPRIN EXTRA STRENGTH Aspirin 500mg. White dispersible tab. marked with logo and DX one side. 16, A2.10. P 1 dissolved in water every 3-4 hours., max. 8 in twenty-four hours. Q Under 16 years, not recommended. D See SPC.
DOZOL
Ricesteele
2K Analgesic/antihistamine. Paracetamol 120mg, diphenhydramine (HCl) 12.5mg per 5ml. Clear amber oral soln with caramel odour. 30ml, A1.42; 100ml, A2.98. S Teething pains, irritability associated with injections or feverishness, aches or pains, colds and flu, associated sleeplessness. Q Under 2 years, contraindicated; 2-6 years, 5-10ml (1-2 teaspoonsful) three or four times daily; over 6 years, 10-20ml three times daily. D Epilepsy, fructose intolerance. B Driving/using machines (may cause drowsiness). Pregnancy (no data). C Contra: Cough and cold medicines, paracetamol containing products. Caution: Alcohol, sedatives. A Rare but hypersensitivity incl. rash may occur.
DUROGESIC DTRANS
Janssen-Cilag
0LO Opiate. Fentanyl 12, 25, 50, 75, 100mcg/hr. Transdermal matrix patches. 12mcg-5,A24.68; 25mcg-5; A35.70; 50mcg-5, A66.68; 75mcg-5, A92.96; 100mcg-5, A114.57. S Chronic intractable pain in patients requiring opioid analgesia. P New opioid patients: Initially one 25mcg/hr patch. May subsequently be titrated up or down, in increments of 12 or 25mcg/hr depending on response. Opioid tolerant patients: Apply strength of patch according to previous
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
137
4.1 PAIN,
ANALGESIA
PYREXIA
analgesics; see SPC. Apply patch to non-hairy area of chest or upper arm. Analgesic effect should not be evaluated until patch worn for 24 hrs. Remove and replace with new patch every 72 hrs using different site. Consider other analgesics if dose exceeds 300mcg/hr. Q Under 2 years, not recommended. Opioid-tolerant paediatric patients ages 2-16 years: Dose based upon daily oral morphine dose,12mcg/ h patch if morphine 30-44mg/day; 25mcg/h patch if morphine 45-134mg/day. Apply to upper back. D Acute pain. Pregnancy, lactation. B Respiratory depression, chronic pulmonary disease, increased intracranial pressure, brain tumour, bradyarrhythmias, renal or hepatic impairment, fever or direct heat. Use in patients who showed opioid tolerance. Tolerance and dependence may develop rarely. Elderly or debilitated patients. Different brands of fentanyl patches are not interchangeable. Dispose of patches with care. Do not admin. in opioid-naive paediatric patients. Risk for life-threatening hypoventilation exists. Not recommended during childbirth. If fever develops, monitor for opioid side-effects. Abuse or intentional misuse may result in overdose and/or death. C Not recommended: CYP3A4 inhibitors, MAOIs. Caution: CNS depressants. A Anorexia, somnolence, insomnia, anxiety, depression, dizziness, muscle contractions involuntary, hypoaesthesia, conjunctivitis, palpitations, yawning, rhinitis, nausea, vomiting, constipation, abdominal pain, dyspepsia, dry mouth, pruritus, UTI, feeling of body temperature change, hyperhidrosis, fatigue, malaise, flu like illness, oedema peripheral, asthenia, drug withdrawal syndrome, fever.
Opioid. Fentanyl (as citrate) 100mcg, 200mcg, 400mcg, 600mcg, 800mcg. Flat-faced, white, round bevelled-edge tab., embossed with C one side and respectively with 1, 2, 4, 6, 8 on the other. 100mcg-4, A34.84; 200mcg-4, A34.84, 400mcg-4, A34.84, 600mcg-4, A34.84, 800mcg-4, A34.84. S Treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. P For buccal administration only; do not suck, chew or swallow. Dose titration: Not switching from other fentanyl-containing products: Initially, 100mcg. If analgesia not obtained within 30 mins, use a 2nd tab of same strength. Titrate upwards as necessary, using 100 or 200mcg tabs up to 400mcg, then using 200mcg, until pain controlled with a single tab per BTP episode. When switching from another oral fentanyl citrate product, independent dose titration required; a starting dose q100mcg may be considered. See SPC. Maintenance therapy: Continue on effective dose established during titration. Max 2 tabs per episode, min 4 hours between doses. Increase dose when more than 1 dose required per BTP episode for several consecutive episodes. Dose readjustment of Effentora and/or background opioid therapy may be required if patients consistently present with more than 4 BTP episodes per 24 hours. R Elderly: Increased caution in titration. Q Under 18 years, not recommended. D Patients without maintenance opioid therapy. Severe respiratory depression or severe obstructive lung conditions. Pregnancy (unless clearly necessary). DYNASTAT Pharmacia B Keep out of reach of children. Closely monitor during titration. The long acting opioid 2N treatment should be stabilised before beginning COX-2 inhibitor. Parecoxib 40mg per vial. After therapy. Caution: Non-severe COPD or other reconstitution 20mg/ml. Powder for soln for inj. conditions predisposing to respiratory depression, Vials: 1 x 10, A83.28. evidence of increased intracranial pressure or S Short term treatment of postoperative impaired consciousness, pre-existing pain. bradyarrhythmias, hepatic or renal impairment. P 40mg IV or IM, followed every 6-12 Hypovolaemia and hypotension. Tolerance and hours by 20-40mg as required. Max. 80mg daily. physical and/or psychological dependence may Q Under 18 years, not recommended. develop. Use in head injury patients only if D Bronchospasm, acute rhinitis, nasal clinically warranted. Lactation (if benefits polyps, angioneurotic oedema, urticaria or outweigh risks). allergic-type reactions after taking acetylsalicylic C CYP3A4 inducers and inhibitors, CNS acid or NSAIDs or other COX-2 inhibitors. Severe depressants. Not recommended: Within 14 days of hepatic impairment, active peptic ulceration or GI MAOIs, partial opioid agonists/antagonists (e.g. bleeding, IBD, severe CHF. Women attempting to buprenorphine, nalbuphine, pentazocine). conceive. Third trimester of pregnancy, lactation. A Dizziness, dysgeusia, somnolence, B Impaired renal function, hypertension, lethargy, headache, tremor, sedation, nausea, compromised cardiac or hepatic function or other vomiting, constipation, stomatitis, dry mouth, conditions predisposing to fluid retention. diarrhoea, pruritis, hyperhydrosis, application site Moderate hepatic impairment. Caution following reactions (incl. pain, ulcer, irritation, paraesthesia, CABG surgery. History of upper GI perforations, anaesthesia, erythema, oedema, swelling and ulcers or bleeds (PUBS). vesicles), fatigue, disorientation, euphoric mood. C Warfarin, diuretics, antihypertensives, FEMINAX Bayer HealthCare ACE inhibitors, cyclosporin, tacrolimus, drug metabolised by CYP2D6 or CYP2C19, lithium, 2 fluconazole, rifampicin, carbamazepine, phenytoin. Compound analgesic/anticholinergic. Paracetamol A Hypertension, hypotension, back pain, 500mg, codeine phos. 8mg, caffeine 50mg, peripheral oedema, hypoaesthesia, alveolar osteitis hyoscine hydrobrom. 0.1mg. White cap.-shaped (dry socket), dyspepsia, flatulence, creatinine scored tab. marked FEMINAX. 20, A3.63. increase, hypokalaemia, agitation, insomnia, post- S Menstrual cramps. operative anaemia, pharyngitis, respiratory P Over 12 years, 1-2 four hourly; max. 6 in insufficiency, pruritus, oliguria. 24 hrs. Q Not applicable. EFFENTORA Cephalon D Glaucoma. Pregnancy. 0LO B Renal or hepatic impairment.
138
A Constipation. Dry mouth, temporary loss of accommodation.
FENTAL
Rowex
0LO Opiate. Fentanyl 25, 50, 75, 100mcg/hr. Matrix transdermal patches. 25mcg-5, A26.06; 50mcg-5, A48.68; 75mcg-5, A67.86; 100mcg-5, A83.65. S Chronic severe pain requiring treatment with opioid analgesics, eg. cancer pain. P Apply on torso or upper arm. Replace after 72 hrs using different skin site. Initially 25mcg/hr. Changing from other oral/parenteral opioid treatment: Initial dose based on quantity of analgesics required over last 24 hrs (see SPC). Evaluate analgesic effect after 24 hrs. May be adjusted in 25mcg/hr increments at intervals of 3 days. Use additional/alternative methods if dose q300mcg/hr. Discontinue gradually. Q Apply to upper back. Under 2 years, not recommended. Opioid-tolerant paediatric patients 2-16 years: Dose based on daily oral morphine dose, see SPC. D Acute or post-operative pain, severely impaired CNS function. Pregnancy (unless essential), lactation. B May cause respiratory depression, hypoventilation. Caution: Chronic obstructive or other pulmonary disease, increased intracranial pressure, brain tumour, bradyarrhythmia, hypotension, hypovolemia, hepatic/renal impairment, fever, direct heat exposure, myasthenia gravis. Elderly, cachectic, or debilitated patients. Driving/operating machines. Tolerance/ dependence (long term use). Apply to nonirritated, non irradiated skin. Do not divide the patch. C MAOIs within 14 days (contra). Caution: CNS depressants (eg. opioids, anxiolytics, tranquilizers, hypnotics, general anaesthetics, phenothiazines, muscle relaxants, sedative antihistamines, alcohol), potent CYP3A4 inhibitors eg. ritonavir, ketoconazole, itraconazole and some macrolide antibiotics (avoid). A GI disorders, somnolence, sedation, headache, drowsiness, confusion, hallucinations, confusion, depression, anxiety, nervousness, lowered appetite, pruritus, appl. site reaction, sweating.
GABAPENTIN TEVA
Teva
2MO GABA analogue. Gabapentin 600mg, 800mg. White to off-white, oval shaped, bevelled edged, film-ctd tab. engraved 7173 (600mg) or 7174 (800mg) on 1 side and 93 the other. 600mg-100, A83.64; 800mg-100, A101.66. S Treatment of peripheral neuropathic pain (e.g. painful diabetic neuropathy, postherpetic neuralgia) in adults. P Initiate by dose titration: 300mg once daily on day 1, increasing to 300mg twice daily on day 2, then 300mg 3 times daily on day 3. Alternatively initiate with 900mg/day given as 3 equally divided doses. Thereafter, can be increased in 300mg/day increments every 2-3 days up to 3600mg/day maximum. Renal impairment, haemodialysis: See SPC. R Adjust according to renal function. D Pregnancy, lactation (unless benefit outweighs risk). B Consider discontinuation if acute pancreatitis develops. Caution in patients with mixed seizures incl. absences. Assess risks/benefits
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA porphyria. B Evaluate benefit/risk: Haematological disturbances, disturbed Na+ metabolism, severe cardiac, liver and kidney dysfunction, myotonic dystrophia, pregnancy, lactation. Patients should consult immediately if fever, sore throat, rash, ulcers in the mouth, easy bruising, petechial or purpuric haemorrhage, nausea, skin yellowing and liver enlargement occurs. Caution: Severe cardiovascular disease, liver disease or renal damage, elderly, glaucoma (regulary check IOP), high doses. May trigger or exacerbate absences. Increase in seizure frequency or the onset of new types of seizures may occur. Test blood regularly; discontinue if severe leucopenia or thrombocytopenia appear. Perform liver function tests periodically. Discontinue if severe dermatological reactions, severe hypersensitivity occur. Avoid sunlight exposure. Driving/operating GABIN Rowex machines. C Not recommended: MAOIs. Caution: 2MO Antiepileptic. Gabapentin 100mg, 300mg, 400mg. Anticonvulsants, CYP450 inducers/inhibitors, digoxin, theophylline, cisplatin, doxorubicin, Hard gelatine caps. with white (100mg), yellow (300mg) or orange (400mg) opaque body. 100mg- clonazepam, St. John’s Wort, azole antimycotics, macrolide antibiotics, isoniazid, Ca++ antagonists, 100, A16.92; 300mg-100, A39.20; 400mg-100, acetazolamide, dextropropoxyphene, A45.36. propoxyphene, viloxazine, danazol, nicotinamide S Peripheral neuropathic pain such as (at high dose in adults), nefazodone, fluvoxamine, painful diabetic neuropathy and post-herpetic terfenadine, loratadine, grapefruit juice, protease neuralgia. P Titrate 300mg once daily (Day 1), twice inhibitors, cimetidine (doses r 800mg), desipramine, phenobarbital, lamotrigine, daily (Day 2) and three times daily (Day 3); primidone, clobazam, ethosuximide, tiagabine, alternatively 300mg three times daily on Day 1 alprazolam, corticosteroids, doxycycline, swallowed whole with water. Can then be dihydropyridines, haloperidol, other neuroleptic increased in 300mg/day increments every 2-3 days drugs, TCAs, trazodone, topiramate, methadone, up to max. 3600mg/day. Renal impairment: See tramadol, anticoagulants, bromperidol, SPC. olanzapine, quetiapine, praziquantel, caspofungin, D Pregnancy, lactation (unless benefit fentanyl, midazolam, phenazone, propranolol, outweighs risk). methylphenidate, flunarizine, quinidine and B Acute pancreatitis (discontinue). Mixed hydroquinidine, tacrolimus, sirolimus, cyclosporine, seizures including absences (caution). Long-term oral contraceptives, HRT, bupropion, psychotropic therapy (q 36 weeks) in children and adolescents drugs, paracetamol, lithium, hypokalaemic (no data). False positive in dipstick tests (total diuretics (loop and thiazide diuretics), urine protein). Driving/operating machines. antiarrhythmics, muscle relaxants, isotretinoin, Contains lactose. thyroid hormones, serotonin re-uptake inhibitors, C Morphine (caution). Take min. 2 hrs clozapine, procarbazine, alcohol. after antacid. A Blood dyscrasias, dizziness, somnolence, A CNS effects eg. somnolence, dizziness, sedation, drowsiness, ataxia, elevated gamma-GT, ataxia. Infections eg. viral, RTI, UTI. Psychiatric fatigue. disorders eg. hostility, confusion, emotional lability. Fatigue, fever, oedema, abnormal gait, INSTANYL Nycomed pain, flu syndrome, arthralgia, myalgia, purpura, 0LO rash, vertigo. Hypertension, vasodilatation, visual Opioid. Fentanyl (as citrate) 50mcg, 100mcg, disturbances. Respiratory/GI disorders. 200mcg/dose nasal spray. Sln. For all strengths: 10, Incontinence, impotence. WBC decreased, A91.70; 20, A183.40. leucopenia, weight gain, appetite change. S Breakthrough pain in patients using Accidental injury. Aggressive behaviour and opioid therapy for chronic cancer pain. hyperkinesias in children. P Initially, 50mcg in one nostril, titrating GERICARB SR Gerard upwards as necessary. Max. daily dose: Treatment of up to 4 breakthrough pain episodes, each with 2MO no more than 2 doses separated by at least 10 Dibenzazepine. Carbamazepine 200mg, 400mg. mins. Maintain with established adequate dose. White to yellowish, round, flat, cloverleaf shaped Wait at least 4 hours before treating new episode. prolonged release tabs with bevelled edge, Q Under 18 years, not recommended. double-sided cross break-mark, 4 notches on band. D Use in opioid-naive patients. Severe Can be divided into equal halves. 200mg-56 respiratory depression or severe obstructive lung A4.48; 400mg-56, A8.85. conditions. Previous facial radiotherapy. Recurrent S Paroxysmal pain of trigeminal neuralgia. episodes of epistaxis. Lactation, pregnancy (unless clearly necessary). P Initially 100-400mg in divided doses increasing gradually to control, usually 600-800mg B Respiratory/circulatory depression, hypotension and shock may occur (monitor daily taken in 1-2 doses. Max. 1600mg daily. May closely). Caution: Elderly, cachectic, or debilitated be gradually reduced if patient is pain-free. patients, moderate to severe renal/hepatic Q Not applicable. impairment, COPD, increased intracranial pressure, D Bone marrow depression, AV impaired consciousness or coma, cerebral tumour, conduction abnormalities, acute intermittent
of prolonged therapy in children and adolescents. Monitor for signs of suicidal ideation and behaviours. False positive in dipstick tests (total urine protein). Withdraw gradually. Pregnancy, lactation. Driving/operating machinery. C Morphine, antacids. A IInfections (e.g. viral, UTI, RTI, otitis media, pneumonia), leucopenia, anorexia, increased appetite, psychiatric and nervous system disorders, visual disturbances, vertigo, hypertension, vasodilatation, dyspnoea, bronchitis, pharyngitis, cough, rhinitis, GI disorders, facial oedema, purpura, rash, pruritus, acne, arthralgia, myalgia, back pain, twitching, incontinence, impotence, fatigue, fever, peripheral or generalized oedema, abnormal gait, asthenia, pain, malaise, flu syndrome, decreased WBC, weight gain.
PAIN,
PYREXIA
4.1
head injury, bradyarrhythmias, hypotonia, hypovolaemia. Driving/using machines. C Avoid: MAOIs (within 14 days), nasal decongestants, partial opioid agonists/ antagonists (e.g. buprenorphine, nalbuphine, pentazocine). Caution: Moderate / strong CYP3A4 inhibitors, CYP3A4 inducers (see Appendix I), other CNS depressants, eg. other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines, alcohol. A Dizziness, somnolence, headache, vertigo, flushing, hot flush, throat irritation, nausea, vomiting, hyperhidrosis.
IXPRIM
Grunenthal Pharma
2O Analgesic. Tramadol HCl 37.5mg, paracetamol 325mg. Pale yellow film-ctd tabs. 60, A13.20.
2O ALSO IXPRIM EFFERVESCENT Tramadol HCl 37.5mg, paracetamol, 325mg. Off white to slightly rosy coloured, with some coloured speckles, round tab. A14.52. S Treatment of moderate to severe pain requiring a combination of tramadol and paracetamol. P Initially, 2 tabs. Additional doses as needed, max 8 tabs/day with dosing interval of no less than 6 hrs. Renal insufficiency: Severe (ccQ10ml/min), not recommended; moderate (10QccQ30ml/min), increase dosing interval to 12 hrs. R Over 75 years old, 6 hrs min interval between doses. Q Over 12 years, as per adults. Under 12 years, not recommended. D Severe hepatic impairment, uncontrolled epilepsy. Pregnancy, lactation. B Severe respiratory insufficiency, not recommended. Not suitable as substitute in opioid-dependent patients. Caution: Opioid dependency, cranial trauma, patients prone to convulsive disorder, biliary tract disorders, shock, altered state of consciousness, problems affecting respiratory centre or respiratory function, increased intracranial pressure. Withdrawal symptoms may occur. Avoid use during light planes of anaesthesia. C Contra: MAO inhibitors up to 2 weeks after withdrawal, acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs. Not recommended: Carbamazepine and other enzyme inducers, opioid agonists-antagonists (buprenorphine, nalbuphine, pentazocine). Caution: SSRIs, triptans, other opioid derivatives, benzodiazepines, barbiturates, anxiolytics, hypnotics, sedative antidepressants, sedative antihistamines, neuroleptics, centrallyacting antihypertensive drugs, thalidomide, baclofen, warfarin-like compounds, CYP3A4 inhibitors, seizure threshold reducing products (e.g. bupropion, TCAs, neuroleptics), metoclopramide, domperidone, cholestyramine, ondansetron. A Dizziness, somnolence, headache, trembling, confusion, mood changes, sleep disorders, GI disorders, sweating, pruritus.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
139
4.1 PAIN,
ANALGESIA
PYREXIA
ulceration or bleeding). History of GI bleeding or perforation, related to previous NSAID therapy. Severe heart failure, hepatic failure and renal Compound analgesic. Paracetamol 500mg, codeine failure. Pregnancy. Contains soya. phosphate 30mg. White oval scored tab. marked B Caution: Elderly, bronchial asthma, KAPAKE. 100, A8.11. asthma, seasonal allergic rhinitis, swelling of nasal S Treatment of severe pain. mucosa, COPD, chronic RTIs, long-term treatment, P 1-2 four hourly as required; max. 8 in hepatic porphyria, severe hepatic impairment, twenty-four hours. defects of haemostasis, bleeding diathesis, Q Under 12 years, not recommended. haematological abnormalities, history of GI D Respiratory depression, obstructed toxicity. Discontinue if liver function worsens. airways, raised intracranial pressure. Acute Monitor renal function: Impaired renal/ liver alcoholism. function, cardiac impairment, elderly, patients B Renal or hepatic impairment, recovering from major surgery. Use after careful hypothyroidism, BPH, inflammatory or obstructive consideration: Uncontrolled hypertension, CHF, bowel disease. Elderly. Labour. Pregnancy, established ischaemic heart disease, peripheral lactation. arterial disease, and/or cerebrovascular disease, C Alcohol or CNS depressants may hyperlipidaemia, diabetes mellitus, smoking. increase any sedative effect. Increased risk of aseptic meningitis with systemic A Tolerance, dependence, constipation, lupus erythematosus (SLE) and mixed connective dizziness, sedation, nausea, dry mouth, blurred tissue disorders. May occur: Allergic reactions; GI vision. bleeding, ulceration or perforation (withdraw); serious skin reactions (rarely), fluid retention, KERAL A. Menarini oedema (caution with hypertension and CHF). May impair female fertility. Lactation (avoid). 2MO C Avoid other NSAIDs. Caution: Diuretics, NSAID. Dexketoprofen (as trometamol) 25mg. antihypertensive agents, cardiac glycosides, A White scored film-ctd tab. 50, 12.62. lithium, digoxin, methotrexate, ciclosporin, S Musculoskeletal pain, dysmenorrhoea, mifepristone, corticosteroids, anti-coagulants, dental pain. (topical gel see Fastum). quinolones, anti-platelet agents, antidiabetics, P 12.5mg every 4-6 hours or 25mg eight tacrolimus, zidovudine, SSRIs. hourly given 30 mins. before food. Max. 75mg A Headache, dizziness, vertigo, GI daily. disorders, increased transaminases, rash. R Initially 50mg daily. Q Not recommended. LEMSIP Reckitt Benckiser D Severe renal or hepatic dysfunction. Active peptic ulcer or history of recurrent GI ulcer. 2 Crohnâ&#x20AC;&#x2122;s disease or ulcerative colitis. Asthma. Analgesic and antipyretic. Paracetamol 500mg per Severe HF. Aspirin/anti-inflammatory induced sachet. Powder for oral soln. with lemon taste. 5, allergy. Pregnancy, lactation. A2.56; 10, A3.81. B History of allergic conditions, S Common cold and flu. haematopoietic disorders. Impaired hepatic, renal 2 or cardiac function. Elderly. ALSO LEMSIP COLD & FLU HEADCOLD C Anticoagulants, lithium, methotrexate, Paracetamol 500mg per sachet. Powder for oral hydantoin, sulphonylureas, b-blockers, cyclosporin, soln. 5, A2.77; 10, A3.98. probenecid. P 1 sachet every 4 hours, if necessary, up A Dyspepsia, heartburn, abdominal pain, to max. of 6 sachets in 24 hrs. headache, dizziness. Q Under 12 years, not recommended.
KAPAKE
Galen
2NO
KYFLAM
Actavis
2MO NSAID. Diclofenac (K+) 50mg. Reddish brown, circular, biconvex film-ctd tab. 56, A6.32. S All grades of pain and inflammation incl. post traumatic pain; acute musculo-skeletal disorders; post-operative pain; painful and/or inflammatory conditions in gynaecology; migraine; acute gout; painful syndromes of vertebral column; non-articular rheumatism; adjuvant in severe painful inflammatory infections of the ear, nose or throat. P Swallow whole with liquid, preferably with or after food. 100-150mg in 2 or 3 divided doses. For milder cases, 75-100mg daily in 2 or 3 divided doses. Max. 150mg/day. Migraine: Initially 50mg at 1st signs of impending attack; if insufficient pain relief within 2 hours after 1st dose, may take further 50mg; if needed, further doses of 50mg may be taken at intervals of 4-6 hours, not exceeding 200mg/day. R Use lowest effective dose; monitor for GI bleeding. Q Over 14 years, 75-100mg in 2 or 3 divided doses. Under 14 years, not recommended. D Active / history of recurrent peptic ulcer / haemorrhage (r2 distinct episodes of proven
140
diabetics, prolonged use. Pregnancy, lactation. Capsules: Caution, history of peptic ulcer. Lemsip Max: Caution, thyrotoxicosis, glaucoma or urinary retention. C Chloramphenicol, coumarin anticoagulants, other drugs affecting liver. Lemsip Max: MAOIs, sympathomimetics.
LYRICA
Pfizer
2MO GABA analogue. Pregabalin 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., marked Pfizer on cap., and PGN and strength on body. 25mg-56, A81.70; 84, A122.55; 50mg-84, A122.55; 75mg-56, A81.70; 100mg-84, A122.55; 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, A81.70. S Peripheral and central neuropathic pain. P Initially, 150mg per day in either two or three divided doses; may be increased to 300mg per day after 3 to 7 days, and to max. 600mg per day after an additional 7-day interval. Discontinue gradually over a min. of 1 week. Renal impairment: Adjust dosage (see SPC). Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. B Withdrawal symptoms may occur. Driving/using machines. Contains lactose. C Caution: Ethanol, lorazepam, antidiabetics (adjust dose). A Dizziness, tiredness. Increased appetite, weight gain, euphoric mood, confusion, change in libido, irritability, attention disturbances, clumsiness, memory impairment, tremor, speech difficulty, paraesthesia, visual disturbances, vertigo, dry mouth, GI disorders, erectile dysfunction, peripheral oedema, drunken feeling, abnormal gait.
MATRIFEN
Nycomed
0LO
Opiate. Fentanyl 12, 25, 50, 75, 100mcg/hr. Transdermal patches. 12mcg/hr-5, A20.39; 25mcg/ hr-5, A29.47; 50mcg/hr-5, A57.00; 75mcg/hr-5, ALSO LEMSIP COLD & FLU MAX STRENGTH A81.05; 100mcg/hr-5, A102.51. Paracetamol 1000mg per sachet. Powder for oral S Severe chronic pain, which can be soln. Blackcurrant & Lemon flavours. 5, A3.43. P 1 sachet up to four times daily; every 4 adequately managed only with opioid analgesics. P New opioid patients: Initially 25mcg/hr hours, if necessary, up to max. of 4 sachets in 24 max. May be titrated in increments of 12 or hrs. 25mcg/hr depending on response. Opioid tolerant Q Under 12 years, not recommended patients: Apply strength of patch according to except on medical advice. previous analgesics; see SPC. Apply patch to chest 2 or upper arm. Evaluate analgesic effect after patch ALSO LEMSIP COLD AND FLU CAPSULES WITH worn min. 24 hrs. Remove and replace with new CAFFEINE Paracetamol 1000mg, caffeine 65mg. patch every 72 hrs using different site. Consider Red and yellow hard gel cap marked Lemsip. 12, other analgesics if dose exceeds 300mcg/hr. A3.84. Q Not recommended. P 2 caps. every 4 hours to a max. of four D Acute and postoperative pain, severe doses in any 24 hours. CNS impairment. Pregnancy (unless clearly Q Under 12 years, not recommended. necessary), lactation. 0 B Respiratory depression may occur. ALSO LEMSIP MAX SINUS & FLU HOT LEMON Chronic pulmonary disease, increased intracranial Paracetamol 1000mg, pseudoephedrine HCI 60mg pressure, coma, brain tumour, bradyarrhythmias, per sachet. Powder for oral soln. 6, A5.31. hypovolemia, hypotonia, renal or hepatic impairment, fever or direct heat. Tolerance and S Sinusitis, common cold and flu. P 1 sachet up to three times daily. Max. of dependence. Elderly or debilitated patients. Driving/using machines. 3 sachets in 24 hrs. C Contra: MAOIs (within 14 days). Avoid Q Not recommended. barbituric acid derivatives, potent CYP3A7 D Hepatic or renal impairment. inhibitors (e.g. ritonavir, ketoconazol, itraconazol, B Impaired kidney and liver function,
2
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
4.1 PAIN,
ANALGESIA
PYREXIA
macrolide antibiotics). Caution: Other CNS depressants, pentazocine, buprenorphine. A GI disorders, somnolence, headache, sedation, depression, anxiety, confusion, hallucinations, lowered appetite, xerostomia, dyspepsia, pruritus, sweating, skin reaction.
MAXILIEF
Clonmel
Compound analgesic. Paracetamol 500mg, codeine phos. 8mg, caffeine 30mg. White effervesc. scored tab. 12, A2.15; 24, A2.91. S Headache, musculoskeletal pain, toothache, backache, common cold, influenza, menstrual pain. P 2 dissolved in water three or four times daily. Q Under 7 years, not recommended; 7-12 years, v-1 in water three or four times daily. B Renal or hepatic impairment. Elderly, prostate hypertrophy, inflammatory or obstructive bowel disorders. Patients on salt restriction. C Metoclopramide, domperidone, cholestyramine, warfarin. Alcohol, CNS depressants (may enhance sedative effect). A Skin rash, constipation, nausea, dizziness, drowsiness. Rowex
2MO NSAID. Mefenamic acid 250mg blue/white cap. marked MEFAC 250. 500mg yellow oval-shaped film-ctd tab. marked MEF500. 250mg-100, A5.21; 500, A25.42; 500mg-100, A9.23. S Mild to moderate pain. Headache. Dental pain. Post-operative or post partum states. Dysmenorrhoea. P 500mg three times daily. Q Not recommended. D Ulcerative lesions of GI tract. Pregnancy, lactation. Renal or hepatic impairment. B Elderly. Bronchial asthma. Allergic disorders. C Anticoagulants. A Diarrhoea, skin rash, headache, bronchospasm, GI disturbance. Renal impairment. Thrombocytopenia.
MELFEN
Clonmel
2MO NSAID. Ibuprofen 200mg, 400mg. Bright pink sugctd tabs. marked with logo and coded 178 or 179. 200mg-100, A2.79; 400mg-100, A4.51; 250, A11.23; 500, A22.06. S Mild to moderate pain. P 1200-1800mg daily in three divided doses. Max. 2400mg daily. Q 20mg/kg body weight daily. Dose should not exceed 500mg daily for children weighing less than 30kg. D Active peptic ulcer. Continuous use over prolonged periods in the elderly. B Aspirin/anti-inflammatory induced allergies. Asthma. Pregnancy. Patients with intracranial haemorrhage and bleeding diathesis. C Oral anticoagulants, thiazide diuretics, lithium, anti-hypertensives diuretics, cardiac glycosides, methotrexate, cyclosporin, other NSAIDs, corticosteroids, aminoglycosides, probenecid and oral hypoglycaemic agents. A Dyspepsia, GI bleeding, rash, rarely thrombocytopenia. Headache, oedema, blurred vision, hypersensitivity, abnormal liver function, renal impairment.
142
Shire
2NO
2KO
MEFAC
can be increased using increments of 300mg per day given in three equally divided doses to a max. of 3600mg per day. Effective dose range is 900Opiate partial agonist. Meptazinol (HCl) 200mg. 3600mg daily. Orange film-ctd oval tab. marked MPL023. 100, Q Under 18 years, not recommended. A24.16; 112, A27.06. B Elderly, haemodialysis, renal impairment S Short term treatment of moderate pain. (see SPC), mood and behavioural disturbances. P 1 three to six hourly as required. Ability to drive or operate machinery may be Q Not recommended. affected. Pregnancy, lactation. 2NO C Caution: Morphine, antacids. ALSO MEPTID INJECTION Meptazinol (HCl) 100mg/ A CNS effect (somnolence, dizziness, dry mouth), GI disturbances (diarrhoea, nausea), ml. Amp. 10 x 1ml, A21.14. headache, asthenia, infection, accidental injury, S Moderate to severe pain, incl. postabdominal pain. operative pain, obstetric pain and pain of renal colic. NEUROSTIL Teva P 75-100mg IM or 50-100mg IV Repeat every two to four hours as required. Obstetric 2MO pain, 2mg/kg body weight IM GABA analogue. Gabapentin 100mg, 300mg, Q Not recommended. 400mg. Resp. grey, orange or brown hard cap. B Hepatic or renal insufficiency. Severe marked resp. 93 and 38, 93 and 39 or 93 and 40. respiratory depression. 100mg-100, A19.89; 300mg-100, A46.12; 400mgA Dizziness, nausea. 100, A53.37. S Neuropathic pain. MST CONTINUS Mundipharma P Initially 900mg/day in 3 divided doses, 0LO titrated by 300mg once daily on day 1, 300mg twice daily on day 2, 300mg three times daily on Opiate. Morphine sulph. 5mg white tab.; 10mg day 3. May be titrated up to max. 3600mg per brown tab.; 15mg light green tab.: 30mg purple tab.; 60mg orange tab.; 100mg grey tab. All film- day. Renal impairement, haemodialysis: See SPC. R Adjust according to renal function. ctd sust.-release tabs. marked with strength and Q Under 18 years, not recommended. NAPP. 5mg-60, A4.75; 10mg-60, A8.94; 15mg-60, A13.88; 30mg-60, A21.46; 60mg-60, A41.83; B Mood and behavioural disturbances A may occur. Monitor for suicidal ideation. 100mg-60, 66.24. Withdraw gradually over at least 1 week. 0LO Pregnancy (only use if clearly needed), lactation. ALSO MST CONTINUS SUSP Morphine (equiv. to Driving/using machines. morphine sulph. 20mg, 30mg, 60mg, 100mg, C Caution: Morphine, antacids. False 200mg). Grans. in sachet for raspberry flavoured positive readings reported with Ames N-Multistix A cont.-release susp. 20mg-30, 30.17; 30mg-30, SG dipstick test. A31.89; 60mg-30, A65.92; 100mg-30, A109.87; A Dizziness, somnolence. See SPC. 200mg-30, A219.74. S Prolonged relief of severe pain. NU-SEALS 300 Alliance P Initially 10-20mg twelve hourly. Severe 2MO pain, 30mg twelve hourly increasing to 60mg twelve hourly when required. If higher doses are Salicylate. Aspirin 300mg. White ent-ctd tab. necessary they should be made in 25%-50% marked 300 in red. 100, A4.76. increments. Mix contents of sachet with min. 10ml S Prolonged pain. water. P 300-900mg 3 or 4 times daily. Max. 8g daily. Q A starting dose in the range of 0.2Q Under 16 years, not recommended. 0.8mg/kg twelve hourly. Doses should be titrated D Hypoprothrombinaemia, haemophilia, as for adults. cerebral haemorrhage, active peptic ulceration, D Pregnancy, lactation. Respiratory lactation. depression, obstructive airways disease. Acute B Not for short-term pain relief. Renal, hepatic disease. Acute alcoholism, head injury, cardiac or hepatic impairment. May induce GI coma, convulsive disorders, raised intracranial haemorrhage. Long-term use, elderly; review pressure. Paralytic ileus. regularly. Caution: History of IBD, coagulation B Hypothyroidism, renal and chronic abnormalities. Hypertension, monitor. Pregnancy hepatic disease. Elderly. Shock, adrenocortical (avoid at term). insufficiency. C AAvoid: Warfarin, heparin, other C MAOIs, CNS depressants. NSAIDs, antacids (simultaneous use). Caution: AntiPhenothiazines, anaesthetics, hypnotics, alcohol. hypertensives, diuretics, cardiac glycosides, lithium, A Tolerance, dependence. Constipation, methotrexate, ciclosporine, tacrolimus, nausea, vomiting. corticosteroids, aminoglycosides, probenecid, oral NEURONTIN Pfizer hypoglycemics, anticoagulants, antiplatelets, fibrinolytics, carbonic anhydrase inhibitors, 2MO ibuprofen. GABA analogue. Gabapentin 100mg white cap.; A Asthma, urate kidney stones, chronic GI 300mg yellow cap.; 400mg orange cap.; 600mg blood loss, tinnitus, nausea, vomiting. white tab.; 800mg white tab. All marked with name and strength. 100mg-100, A24.86; 300mgNUROFEN Reckitt Benckiser 100, A57.65; 400mg-100, A66.71; 600mg-100, 2K A104.55; 800mg-100, A127.08. NSAID. Ibuprofen 200mg. White sug-ctd tab. 12, S Treatment of neuropathic pain. A2.12; 24, A3.53; 48, A5.86. P Initially 300mg once daily on day 1, 2K increasing to 300mg twice daily on day 2, then 300mg three times daily on day 3. Thereafter dose ALSO NUROFEN LIQUID CAPSULES Ibuprofen
MEPTID
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA 200mg. Liquid in red cap. marked NUROFEN. 16, A3.24. S Mild to moderate pain such as headache, dental pain, backache, feverishness, period pain, muscle strain, neuralgia, rheumatic pain, migraine, management of symptoms of head cold and influenza. P Initially 2 followed by 1-2 four hourly. Max. 6 in 24 hours. Q Under 12 years, see Nurofen for children. Over 12 years, same as adults.
PAIN, C Warfarin, heparin, anti-hypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin, NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycaemics, anti platelet agents, SSRIs. (In addition for Plus only, MAOIs). A GI disturbance/bleeding, peptic ulcer, allergic reactions, thrombocytopaenia. In addition for Plus, constipation, breathing difficulties).
ORAMORPH ORAL SOLUTION
2K ALSO NUROFEN PLUS Ibuprofen 200mg, codeine phosphate 12.8mg. White cap.-shaped tab. 12, A3.09; 24, A5.26. S Migraine, cramping period pain, dental pain, sciatica, lumbago, rheumatic pain. P Initially 2 followed by 1-2 four hourly. Max. 6 in 24 hours. Q Under 12 years, not recommended.Over 12 years, same as adults.
2K ALSO NUROFEN FOR CHILDREN Ibuprofen 100mg/ 5ml. Oral susp. 100ml, A3.59; 150ml, A5.06. S Reduction of fever and relief of mild to moderate pain, such as cold and flu symptoms, toothache, headache, sprains and strains and to ease the pain of sore throats and earache. Q Short term use only; not more than at 6 hourly intervals. Under 3 months, doctors recommendation only. 3-6 months (only if q 5kg), 2.5ml three times daily. 6-12 months, 2.5ml three times daily. 1-3 years, 5ml three times daily. 4-6 years, 7.5ml three times daily. 7-9 years, 10ml three times daily. 10-12 years, 15ml three times daily.
2K ALSO NUROFEN FOR CHILDREN MELTLETS Ibuprofen 100mg. White round, orodispersible tab. 12, A2.93. Q Over 6 years only. 20-30mg/kg body weight in divided doses, as follows; 6-9 years: Initially 2 tab., then if necessary 2 tab. every 4-6 hours. Max. 6 tab. in 24 hours. 10-12 years: Initially 3 tab., then if necessary 3 tab. every 4-6 hours. Max. 9 tab. in 24 hours.
2K ALSO NUROFEN FOR CHILDREN SUPPOSITORIES AGE 3 MONTHS-2 YEARS Ibuprofen 60mg. White or yellowy-white cylindrical suppositories. 10, A4.66. S Reduction of fever and relief of mild to moderate pain, such as teething pain, toothache, headache, sprains and strains and to ease the pain of sore throats and earache. Relief of pain and fever associated with colds and influenza. Q For rectal use only. 3 - 9 months (6 8kg), 1 suppositary 3 times daily at 6 - 8 hours interval. 9 months - 2 years (8 - 12kg), 1 suppositary 4 times daily at 6 hours interval. D History of/or existing stomach ulcer, other GI disorders. History of asthma, rhinitis, urticaria associated with aspirin or other NSAIDs. In case of Nurofen Plus only, chronic constipation, breathing difficulties. B Asthma, renal, cardiac or hepatic impairment, intracranial haemorrhage and bleeding diathesis, history of GI disease (ulcerative colitis, Crohn’s disease), elderly. Pregnancy, lactation. (In addition for Plus only, low BP, head injury, thyroid disease). May occur: GI bleeding, ulceration or perforation, arterial thrombotic events, serious skin reactions (discontinue). Meltlets contain aspartame.
Boehringer Ing.
0LO Opiate. Morphine sulph. 10mg/5ml. Sugar-based oral soln. 100ml, A2.85; 300ml, A7.56; 500ml, A11.40.
0LO ALSO ORAMORPH CONC. ORAL SOLUTION Morphine sulph. 20mg/ml. Sugar-free oral soln. 30ml, A7.60; 120ml, A28.40. S Relief of severe and intractable pain and in short term control of post-operative pain. P Usual dose 10-20mg four hourly. Q Under 1 year, not recommended; 1-5 years, max. 5mg four hourly; 6-12 years, up to 510mg four hourly. D Pregnancy, lactation. Respiratory depression, obstructive airways disease, acute asthma exacerbations. Acute hepatic disease. Acute alcoholism, head injury, coma, convulsive disorders, raised intracranial pressure. Paralytic ileus. B Hypothyroidism, controlled asthma, renal and chronic hepatic disease. Elderly. Shock, adrenocortical insufficiency. C MAOIs, CNS depressants, phenothiazines, anaesthetics, hypnotics, alcohol. A Tolerance, dependence. Constipation, nausea, vomiting.
PYREXIA
4.1
acute alcoholism, chronic renal and hepatic disease, debilitated patients. Abdominal surgery, possibility of paralytic ileus occurring. C MAOIs, CNS depressants, phenothiazine, TCADs, anaesthetics, hynotics, sedatives, alcohol, musclerelaxants, antihypertensives, cimetidine. A Respiratory depression, tolerance, constipation, nausea, dizziness, vomiting, headache, dry mouth, sweating, drowsiness, asthenia. Abrupt withdrawal may result in a withdrawal syndrome.
OXYNORM
Mundipharma
0LO Opiate. Oxycodone (HCl) 5mg orange/beige cap., 10mg white/beige cap., 20mg pink/beige cap. All marked ONR and 5, 10 or 20. 5mg-56, A11.07; 10mg-56, A30.90; 20mg-56, A61.79.
0LO ALSO OXYNORM CONCENTRATE Oxycodone (HCl) 10mg/ml. Oral soln. 120ml, A66.16. S Severe pain. P The dosage should be titrated depending on the severity of the pain, previous history of analgesic requirements and body weight. The usual starting dosage for opioid naive patients is 5mg 4-6 hourly. The dosage should be titrated in 25-50% increments. Q Under 20 years, not recommended.
0LO
ALSO OXYNORM INJECTION Oxycodone (HCl) 10mg/ml. Soln. for inj. or inf. in amps. 5x1ml, A7.10; 5x2ml, A14.27. P IV: Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water for inj; bolus: 1-10mg slowly over 1-2 mins, not more than every 4 hours; inf: Initially 2mg/hour; PCA: Bolus doses of 0.03mg/kg with min. lock-out time of 5 mins. SC: Bolus: Use as 10mg/ml concentration, initially 5mg repeated at 4-hourly intervals as required; inf: Dilute if OXYCONTIN Mundipharma required, initially 7.5mg/day in opioid naive patients, titrating gradually according to symptom 0LO control. Transferring from oral oxycodone, 2mg Opiate. Oxycodone (HCl) 5mg blue tab., 10mg oral oxycodone equiv. 1mg parenteral oxycodone. white tab.; 20mg pink tab.; 40mg yellow tab. 80mg green tab. All modified release tabs. marked Q Under 18 years, not recommended. D Respiratory depression, head injury, OC and 5, 10, 20, 40 or 80 on reverse. 5mg-28, paralytic ileus, acute abdomen, delayed gastric A12.58; 10mg-56, A20.29; 20mg-56, A40.58; emptying, chronic obstructive airways disease, 40mg-56, A79.87; 80mg-56, A147.02. chronic bronchial asthma, cor pulmonale, S Severe pain. hypercarbia, acute hepatic disease. Pregnancy, P The dosage should be titrated lactation. depending on the severity of the pain, previous B Hypothyroidism, opioid dependent history of analgesic requirements and body weight. tabs. should be swallowed whole and not patients, raised intracranial pressure, hypotension, hypovolaemia, diseases of the biliary tract, chewed. The correct dosage for any individual patient is that which controls the pain and is well pancreatitis inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, tolerated for a full 12 hours. In debilitated elderly patients or opioid naive patients the usual starting acute alcoholism, chronic renal and hepatic disease, debilitated patients. Abdominal surgery, dose is 10mg twelve hourly. The dose should be possibility of paralytic ileus occurring. titrated in 25-50% increments. C Contra: MAOIs or within 2 weeks of use. Q Under 20 years, not recommended. Caution: CNS depressants, phenothiazine, TCADs, D Respiratory depression, head injury, anaesthetics, hynotics, sedatives, alcohol, paralytic ileus, acute abdomen, delayed gastric musclerelaxants, antihypertensives, quinidine, emptying, severe obstructive airways disease, cimetidine, CYP3A4 substrates/inhibitors. severe bronchial asthma, hypercarbia. Concurrent A GI disorders, dry mouth, dizziness, admin. of MAOIs or within 2 weeks of discontinuation of use. Pre-operatively and for 24 headache, somnolence, anxiety, confusion, insomnia, asthenia, dyspnoea, bronchospasm, hours post-operatively. Sensitivity to morphine or orthostatic hypotension, pruritus, urinary other opioids. Acute hepatic disease. Pregnancy, disorders, fever, chills. Tolerance, withdrawal lactation. syndrome. B Hypothyroidism, opioid dependent patients, raised intracranial pressure, hypotension, PALLADONE SR Mundipharma hypovolaemia, diseases of the biliary tract, 0LO pancreatitis inflammatory bowel disorders, prostatic hypertrophy, adrenocortical insufficiency, Opiate. Hydromorphone (HCl) 2mg yellow/clear
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
143
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ANALGESIA
PYREXIA
cap.; 4mg pale blue/clear cap. marked HCR4; 8mg pink/clear cap. marked HCR8; 16mg brown/clear cap. marked HCR16; 24mg dark blue/clear cap. marked HCR24. 2mg-56, A24.75; 4mg-56, A26.03; 8mg-56, A50.76; 16mg-56, A95.43; 24mg-56, A137.43. S Relief of severe pain. P Caps. may be swallowed whole or contents sprinkled onto soft food, taken at 12 hourly intervals. Dosage depends on severity of pain. See SPC. Q Under 12 years, not recommended.
0LO ALSO PALLADONE Hydromorphone (HCl) 1.3mg orange/clear cap. marked HNR1.3; 2.6mg red/clear cap. marked HNR2.6. 1.3mg-56, A8.58; 2.6mg-56, A17.17. P Caps. may be swallowed whole or contents sprinkled onto soft food, taken at 4 hourly intervals. Dosage depends on severity of pain. See SPC. Q Under 12 years, not recommended. D Pregnancy, lactation, respiratory depression. Acute alcoholism, head injury, coma, convulsive disorders, raised intracranial pressure, paralytic ileus. B Elderly, hypothyroidism, chronic obstructive airways disease, renal and chronic hepatic disorders, shock, adrenal insufficiency, prostatic hypertrophy. C MAOIs, CNS depressants, tranquillisers, anaesthetics, hypnotics, sedatives. A Tolerance, dependence, constipation, nausea, vomiting.
PARALIEF
Clonmel
2MO Analgesic. Paracetamol 500mg. White cap.-shaped tab. marked with logo one side and coded 293 with partial score line on reverse. 24 (OTC) A1.26; 100 A0.97; 250, A2.44;1000 A9.24. S Analgesic and antipyretic. P 2 three or four times daily. Q Not recommended. B Renal or hepatic impairment. C Absorption may be delayed by drugs such as anti-cholinergic agents or opiate analgesics, which decrease gastric emptying. Likelihood of toxicity may be increased by concomitant use of enzyme inducing agents such as alcohol or anti-epileptic drugs. Repeated doses of paracetamol somewhat increase the anticoagulant response to coumarins and paracetamol may also increase the chloramphenical concentration. A Skin rashes and other allergic reations occur occasionally. Haematological reactions have been reported.
susp. 140ml, A5.05. S Analgesic and antipyretic. Q Under 3 months, 2.5ml; 3 months-1 year, 2.5-5ml; 1-6 years, 5-10ml; 6-12 years, 1020ml. All three or four times daily.
2 ALSO PARAPAED SIX PLUS Paracetamol 250mg/ 5ml. Sugar-free susp. 70ml, A4.30. P 10-20ml four to six hourly; max. 4g daily. Q Under 6 years, not recommended; 6-12 years, 5-10ml four to six hourly; max. 2g daily. B Renal or hepatic impairment
PARATABS
Pinewood
2K
Analgesic. Paracetamol 500mg. White cap.-shaped tab., scored on one side. 12, A1.10; 24, A1.55. S Management of symptoms of headache, toothache, common cold, influenza, menstrual pain and musculo-skeletal disorders. P 2 tabs. 3 to 4 times daily; max. 8 tabs in 24 hours. Q 6-12 years: v- 1 tab. 3 to 4 times daily. PARALINK Ricesteele Max. 4 tabs. in 24 hours. Under 6 years: Tabs. not recommended, use elixir. 2K B Lactation (excreted in breast milk, Analgesic. Paracetamol 120mg/5ml. Colourless oral consider risk/benefit). Prolonged use except under sln with raspberry odour and taste. 100ml, A2.11. medical supervision may be harmful. Hepatic/renal S Analgesic and antipyretic. Mild to impairment or alcohol dependence (caution). moderate pain; for the relief of symptoms of colds C Other paracetamol-containing products and influenza and to lower temperature. (not recommended). Cholestyramine, warfarin, Q 3 months-1 year, 5ml. 1-5 years, 5-10ml. zidovudine, domperidone, metoclopramine. Over 6 years, 10-20ml. All 3 or 4 times daily. A Rashes, blood disorders and acute 2KO pancreatitis reported. PANADEINE GSK ALSO PARALINK SUPPOSITORIES Paracetamol 180mg, 500mg. Suppos. 180mg-10, A4.42; 500mg- PERFALGAN 2 BMS Compound analgesic. Paracetamol 500mg, codeine 10, A5.38. 2JN phos. 8mg. White scored tab. marked PANADEINE. S Pain and fever associated with such Analgesic. Paracetamol 1g/100ml. Vial containing conditions as influenza, common cold, headache, 24, A3.20; 48, A4.69. 100 ml of soln. for infusion. 12, A54.72. rheumatism, teething and post operative S Painful and febrile conditions. S Moderate pain (especially following discomfort. P 1-2 three to four times daily. surgery) and fever, when admin. by IV route P 1-2 x 500mg six hourly. Q Under 7 years, not recommended; 7-12 clinically justified and/or when other admin. routes Q 3 months-1 year (5-10kg body weight), years, v-1 three or four times daily. not possible. v x 180mg. 1-3years (10-15kg body weight), 1 x B Renal or hepatic impairment. P 15-min. IV infusion. More than 50kg: 1g 180mg. 3-6years (15-20kg body weight), 1v x up to 4 times a day. Less than 50kg: 15 mg/kg per PANADOL GSK 180mg. 6-12 years (20-90kg), 1 x 500mg. All 6 admin. Max. daily dose: 60mg/kg, not exceeding hourly. 2 4g. Minimum interval between each admin: 4 B Renal or hepatic impairment. hours. Severe renal impairment, 6 hrs interval Analgesic. Paracetamol 500mg. White film-ctd A Rare but hypersensitivity incl. skin rash minimum. Hepatocellular insufficiency, chronic cap.-shaped scored tab. marked PANADOL in blue may occur. Some reports of blood dyscrasias incl. A A A alcoholism, chronic malnutrition, dehydration: 3g both sides. 12, 1.16; 24, 2.00; 96, 5.01. thrombocytopoenia and agranulocytosis but not max daily. 2 necessarily causally related to paracetamol. Q More than 33 kg (approx. 11 years old), ALSO PANADOL SOLUBLE Paracetamol 500mg. as for adults weighing less than 50kg. White scored effervescent tab. 24, A3.03. PARAMOL Galen D Severe hepatocellular insufficiency. S Analgesic and antipyretic. 2 N O B Hepatocellular insufficiency, severe renal P 2 three or four times daily. insufficiency, chronic alcoholism, chronic Q Under 6 years, use elixir or Junior; 6-12 Compound analgesic. Paracetamol 500mg, dihydrocodeine tartrate 10mg. White tab. marked malnutrition (low reserves of hepatic gluthatione), years, v-1 tab. A A PARAMOL. 100, 2.45; 500, 11.64. dehydration. Very serious liver damage risk at 2 doses higher than recommended. Pregnancy. S Mild to moderate pain. ALSO PANADOL EXTRA Paracetamol 500mg, C Probenecid, salicylamide, enzymeP 1 four hourly during or after meals caffeine 65mg. White cap.-shaped film-ctd tab. 12, inducing substances, oral anticoagulants. increasing to 2 four times daily if necessary. A1.36; 24, A2.36. Q Not recommended. P 2 up to four times daily; max. 8 in PHYMET DTF GSK D Respiratory depression, obstructive twenty-four hours. airways disease. 0L Q Under 12 years, not recommended. B Allergic disorders. Renal or hepatic 2 Opiate. Methadone HCl, 1mg/ml. Clear green impairment, hypothyroidism. Elderly. Pregnancy. viscous oral solution. ALSO PANADOL BABY & INFANT Paracetamol 120mg/5ml. Strawberry flavoured sugar-free susp. C Alcohol, CNS depressants. S Relief of severe pain in conditions A Constipation. Rarely nausea, headache. 100ml, A2.52. where morphine may be a reasonable alternative See SPC. (severe cancer pain). P Up to 20ml four times daily. P Initially, 5-10mg admin. orally. Adjust Q 3 months-1 year, 2.5-5ml; 1-6years, 5PARAPAED JUNIOR Pinewood according to individual response. Twice daily max. 10ml; 6-12years, same as adult. All four times 2 in chronic use. May be used in combination with daily. Analgesic. Paracetamol 120mg/5ml. Sugar-free non-narcotic analgesics. Renal impairment: B Renal or hepatic impairment.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA
PAIN,
PYREXIA
4.1
aminoglycosides, probenecid, oral hypoglycaemics. A GI disturbance, diarhoea, headache, bronchospasm, rash, renal dysfunction, thrombocytopenia and other blood dyscrasias.
systemic baclofen, clonidine, bupivacaine or propofol, CNS depressants. Partial opioid agonists, no data. A Anorexia, confusional state, psychiatric disorders, dizziness, memory impairment, PONSTAN Chemidex headache, eye disorders, vertigo, tinnitus, hypotension, dyspnoea, GI disorders, sweating, 2MO rash, pain, muscle disorders, arthralgia, urinary NSAID. Mefenamic acid 250mg. Ivory/blue cap. disorders, gait abnormal, fatigue, pyrexia, oedema A A marked PONSTAN 250. 100, 5.70; 500, 25.61. peripheral, rigors, fall, feeling cold, jittery. S Pain associated with rheumatic, muscular or arthritic disorders, trauma, headaches, McNeil Healthcare dental pain, post-operative or post-partum states. PROVIN 2K Pyrexia in children. 2MO NSAID. Ibuprofen 100mg/5ml. Oral suspension. Sugar free, colour free and strawberry flavour. ALSO PONSTAN FORTE Mefenamic acid 500mg. 100ml- A3.12; 150ml-A4.38. Yellow film-ctd tab. 100, A10.40. S Mild to moderate muscular pain. S Pain associated with rheumatic, Headache, earache, dental pain and backache. muscular or arthritic disorders, trauma, headaches, dental pain, post-operative or post-partum states. Minor injuries such as sprains and strains. Feverishness and symptoms of colds and influenza. P Daily dose, 1500mg in divided doses. Q Under 7kg or under 6 months, not Q Under 12 years, not recommended. recommended. Pain and fever: 20mg/kg/day in D Ulceration or inflammation of GI tract. IBD. Active or recurrent peptic ulcer/haemorrhage. divided doses. Infants 6-12 months: 2.5ml three times a day. 1-2 years: 2.5ml three to four times a Renal or hepatic impairment. Severe HF. day. 3-7 years: 5ml three to four times a day. 8-12 Pregnancy, lactation. years: 10ml three to four times a day. B Hypersensitivity (discontinue). Elderly, D Peptic ulceration (or history). Patients in dehydration, renal disease, cardiac impairment, whom NSAIDs induce symptoms of asthma, rhinitis intracranial haemorrhage, bleeding diathesis, epilepsy, asthmatics, history of peptic ulceration or or urticaria. Severe hepatic/renal failure or HF. IBD, history of SLE, female fertility. Long term use: B Elderly. Use lowest effective dose. May cause dose dependent renal toxicity in at risk Monitor for liver function, rash, blood dyscrasias, patients. Impaired renal/heart failure or liver diarrhoea. Contains: Lactose, quinoline/sunset dysfunction. Coagulation defects. Bronchial yellow. asthma or allergic disease. If symptoms persist q 3 C Contra: Other NSAIDs. Caution: days, consult your doctor. Do not exceed the Anticoagulants, lithium, SSRIs, antihypertensives, stated dose. Pregnancy (avoid). diuretics, ACE inhibitors, ARBs, aminoglycosides, C Avoid: Other analgesics. Caution: cardiac glycosides, anti-platelets, methotrexate, Antihypertensives, diurectics, cardiac glycosides, ciclosporin, mifepristone, corticosteroids, lithium, methotrexate, cyclosporin, mifepristone quinolones, tacrolimus, probenecid, oral (or within 8-12 days), corticosteroids, hypoglycaemics. anticoagulants, quinolone antibiotics. A Diarrhoea, rash, GI toxicity, headache, A GI disorders, peptic ulceration, GI convulsions, insomnia, dizziness, drowsiness, bleeding. nervousness, asthma, dyspnoea, hypotension, palpitations, ear pain, eye irritation, reversible loss Ranbaxy PONALGIC Antigen of colour vision, blurred vision, glucose intolerance RANGABAX in diabetics, hyponatraemia, facial / laryngeal 2MO 2MO oedema, skin/ renal/ hepatic/ blood disorders, GABA analogue Gabapentin 100mg, 300mg, NSAID. Mefenamic acid 250mg. Yellow/blue cap. hypersensitivity, anaphylaxis. 400mg, 800mg. 100mg: White opaque hard cap. marked ANTIGEN and coded MA250. 100, A4.67; (size 4) marked G100 on cap and body. 300mg: 500, A23.81. PRIALT Eisai Ivory opaque hard cap. (size 0) marked G300 on 2MO 2 N O cap and body. 400mg: Orange opaque hard cap. ALSO PONALGIC FORTE TABLETS Mefenamic acid ++ (size 0) marked G400 on cap and body. 800mg: 500mg. Yellow film-ctd tab. marked with logo and Ca channel blocker. Ziconotide (as ziconotide A acetate) 100mcg/ml. Sln for inf. 1ml, 339.29; 5ml, White to off-white, oval, biconvex film-ctd tab. coded MA500. 100, A9.31. A1,696.43. marked G800 on one side. 100mg-100, A14.48; S Mild to moderate pain incl. headache, 300mg-100, A30.93; 400mg-100, A37.47; 800mgS Severe, chronic pain in patients who dental or post-op pain, rheumatic, muscular or 100, A82.91. require intrathecal (IT) analgesia. arthritic pain. Primary dysmenorrhoea. S Treatment of peripheral neuropathic P Initially 2.4mcg/day. Titrate individually Dysfunctional menorrhagia. pain (e.g. painful diabetic neuropathy and postin increments of R 2.4mcg/day up to 21.6mcg/day P 500mg three times daily. herpetic neuralgia ) in adults. (max). Min. interval between dose increases is 24 Q Not recommended. P Initiate by dose titration: 300mg once D Ulcerative lesions or inflammation of GI hrs; recommended interval is r 48 hrs. daily on day 1, increasing to 300mg twice daily on Q Under 18 years, not recommended. tract. Renal or hepatic impairment. Pregnancy, day 2, then 300mg three times daily on day 3. D Pregnancy, lactation (unless clearly lactation. Aspirin/NSAID induced bronchospasm, Alternatively initiate with 900mg/day given as 3 necessary). rhinitis or urticaria. B Long-term use, systemic chemotherapy. equally divided doses. Thereafter, can be increased B Elderly. Renal dysfunction. Regular in 300mg/day increments every 2-3 days up to surveillence if therapy is prolonged. Discontinue if Monitor: For meningitis; myopathy (creatine 3600mg/day max. See SPC. Renal impairment, kinase levels). Consider catheter tip placement liver dysfunction, rash, blood dyscrasias or haemodialysis: See SPC. carefully. Discontinue if signs/symptoms of diarrhoea occur. Cardiac or hepatic impairment. R Adjust according to renal funtion. cognitive impairment or neuropsychiatric adverse History of peptic ulcer or inflamatory bowel B Consider discontinuation if acute reactions develop. Depressed levels of disease. Intracranial haemorrhage or bleeding pancreatitis develops. Caution in patients with consciousness, discontinue if occurs.May cause/ diathesis. mixed seizures incl. absences. Assess risks/benefits worsen depression with risk of suicide in C Anticoagulants, other plasma protein of prolonged therapy in children and adolescents. susceptible patients. bound drugs. Antihypertensives, diuretics, Monitor for signs of suicidal ideation and C Contra: IT chemotherapy. Caution: cardiacglycosides, lithium, methotrexate, behaviours. False positives in dipstick tests (total cyclosporin, other NSAIDs, corticosteroids, Systemic chemotherapy, IT morphine, opiates,
Caution. GFR 10-50ml/min, dosage interval 8 hourly minimum; GFRQ10ml/min, dosage interval 12 hourly minimum. Hepatic impairment: Use less than normal recommended dose, using patient’s response as guide. R Careful monitoring advised. Q Not recommended. D Respiratory depression (esp. cyanosis, excessive bronchial secretions), bronchial asthma attack, acute alcoholism, head injury, raised intracranial pressure, ulcerative colitis, severe hepatic impairment, biliary and renal tract spasm, labour. B May occur: Deaths due to cardiac arrhythmias and respiratory depression (caution during dose initiation and adjustment period), QT interval prolongation and serious arrhythmia (particularly at high doses; caution and careful monitoring of patients at risk of prolonged QT interval, known history, advanced heart disease, ischaemic heart and liver disease, concomitant drugs that prolong QT interval), morphine type dependence. Caution: Hypothyroidism, adrenocortical insufficiency, hypopituitarism, prostatic hypertrophy, shock, phaeochromocytoma (particularly in association with diamorphine). Pregnancy, lactation. C Contra: MAOIs (or within 14 days of stopping). Caution: Rifampicin, phenytoin, carbamazepine, St John’s Wort, antiretrovirals (e.g. nevirapine, efavirenz, some protease inhibitors), fluconazole, some SSRIs (particularly fluvoxamine), CYP3A4 inhibitors, drugs known to have potential for QT interval prolongation, class I and III antiarrhythmics, some neuroleptics, TCAs, Ca++ channel blockers, diuretics, laxatives, mineralocorticoid hormones, nelfinavir, zidovudine, fluconazole, desipramine, other centrally-acting agents (alcohol, barbiturates, neuromuscular blocking agents, phenothiazines and tranquillisers, some psychotropic drugs). A Confusion, dizziness, drowsiness, lightheadedness, GI disorders, sweating, urinary retention/hesitancy.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
145
4.1 PAIN,
ANALGESIA
PYREXIA
urine protein). Withdraw gradually. Driving/ operating machinery. C Morphine (monitor for CNS depression). Antacids. A Infections (e.g. viral, UTI, RTI, otitis media, pneumonia), leucopenia, anorexia, increased appetite, psychiatric and nervous system disorders, visual disturbances, vertigo, hypertension, vasodilatation, dyspnoea, bronchitis, pharyngitis, cough, rhinitis, GI disorders, facial oedema, purpura, rash, pruritus, acne, arthralgia, myalgia, back pain, twitching, incontinence, impotence, fatigue, fever, peripheral or generalised oedema, abnormal gait, asthenia, pain, malaise, flu syndrome, decreased WBC, weight gain.
ALSO SOLPADEINE CAPSULES Paracetamol 500mg, codeine phos. 8mg, caffeine 30mg. Red/white cap. marked Solpadeine. 12, A1.92; (GMS)24, A1.97; (GMS)32, A2.63. P 2, three or four times daily. Q Under 12 years, not recommended.
TARGIN
Mundipharma
5L
Opiate/opioid antagonist. Oxycodone HCl/ naloxone HCl 10mg/5mg; 20mg/10mg. Resp. white or pink oblong film-ctd tab. marked OXN on one side and 10 or 20 on the other. 10mg/5mg-56, 2 A95.82; 20mg/10mg-56, A49.93. ALSO SOLPADEINE TABLETS Paracetamol 500mg, S Severe pain, which can be adequately codeine phos. 8mg, caffeine 30mg. White cap. managed only with opioid analgesics. Contains shaped tab. marked Solpadeine. 12, A2.18; 24, naloxone to counteract opioid-induced A3.58. constipation. S Rheumatic and musculo-skeletal pain; P Adjust to pain intensity and patient headaches, sinusitis and influenza. sensitivity. Opioid-naive: 10mg/5mg at 12 hourly P 2, three or four times daily. intervals. Patients already on opioids: May be Q Under 12 years, not recommended. started on higher dose, depending on previous D Lactation. opioid experience. Max. daily dose 40mg/20mg B Renal or hepatic impairment. Patients (e.g. twice daily 20mg/10mg). Supplemental RESPRIN Ricesteele on salt restriction. prolonged-release oxycodone may be given at C Alcohol or CNS depressants may 2KO same time intervals, taking into account max. daily Salicylate. Aspirin 150mg, 300mg. Suppos. 150mg- increase any sedative effect. dose of 400mg prolonged-release oxycodone. Use A Constipation. 10, A2.52; 300mg-10, A2.85. lowest effective analgesic dose. See SPC. S Antipyretic, analgesic and antiQ Under 18 years, not recommended. SOLPADOL sanofi-aventis inflammatory agent in the management of mild D Opioid contraindications. Severe to moderate pain, e.g. headache, toothache, 2NO respiratory depression with hypoxia and/or rheumatism etc. Compound analgesic. Paracetamol 500mg, codeine hypercapnoea. Severe COPD. Cor pulmonale. P 600-900mg four to six hourly. phos. hemihydrate 30mg. White effervescent Acute severe bronchial asthma. Non-opioid D Known hypersensitivity to any of the scored tab. 100, A11.56. induced paralytic ileus. Moderate to severe hepatic ingredients. 2NO impairment. Lactation. B Use in children, particularly under 12 ALSO SOLPADOL CAPLETS Paracetamol 500mg, B Not suitable for treating withdrawal years, should be avoided unless essential. codeine phos. 30mg. White cap.-shaped tab. symptoms. Safety and efficacy not established in Particular caution necessary in the presence of marked SOLPADOL. 100, A9.32. patients with cancer and/or liver metastasis. viral infections. S Severe pain. Caution: Elderly or infirm patients, opioid-induced C Anticoagulants, uricosurics, insulin P 2 tabs four hourly; max 8 in 24 hours. paralytic ileus, severely impaired pulmonary A Bronchospasm, attacks of asthma in R Dose may need to be reduced. function, myxoedema, hypothyroidism, Addisonâ&#x20AC;&#x2122;s susceptible individuals. Q Under 12 yrs, not recommended. disease, toxic psychosis, cholelithiasis, prostate D Respiratory depression, acute asthma, hypertrophy, alcoholism, delirium tremens, SEVREDOL Mundipharma acute alcoholism, head injury, raised intracranial pancreatitis, hypotension, hypertension, pre0LO pressure, following biliary tract surgery, patients existing cardiovascular diseases, head injury, Opiate. Morphine sulph. 10mg, 20mg, 50mg. Blue, currently receiving or within 14 days of stopping epileptic disorder or predisposition to convulsions, MAOI. Pregnancy, lactation. pink or green film-ctd cap.-shaped, scored tabs. mild hepatic or renal impairment (severe renal B Severe renal or hepatic impairment. marked IR and tab. strength. 10mg-56, A7.68; impairment, careful monitoring). Long-term opioid Prostatic hypertrophy, inflammatory or obstructive treatment with higher opioid doses, withdrawal 20mg-56, A15.36; 50mg-56, A34.17. bowel disorders. Elderly. Concurrent CNS S Acute and chronic, severe pain. symptoms may occur. Withdraw gradually. Not P Initially 10mg four hourly, then adjusted depressant drugs. Prolonged use. Tolerance and recommended for pre-operative use or within 1st dependence. Withdrawal symptoms may occur. according to response. The dosage can be 12-24 hours post-operatively. Pregnancy (only use Driving/operating machinery. Overdose. increased under medical supervision according to if benefits outweigh risks). Contains lactose. the severity of the pain and the patientâ&#x20AC;&#x2122;s previous Effervescent tabs contain sorbitol. C Caution: MAOIs, CNS-depressants, C Chloramphenicol, oral contraceptives, history of analgesic requirements. coumarin anticoagulants. metoclopramide, domperidone, colestyramine, Q Under 3 years, not recommended; 3-5 A Decreased/loss of appetite, anxiety, warfarin and other coumarins. Alcohol. Avoid years, 5mg four hourly; 6-12 years, 5-10mg four restlessness, headache, sedation, tremor, vertigo, hourly. other paracetamol containing products. BP decrease, rhinorrhoea, yawning, GI disorders, D Pregnancy, lactation. Respiratory A Codeine: Constipation, nausea, pruritus, skin reactions, hyperhidrosis, muscle depression, obstructive airways disease. Acute vomiting, dizziness, light-headedness, confusion, spasms, muscle twitching, myalgia, drug hepatic disease. Acute alcoholism, head injury, drowsiness and urinary retention. Paracetamol: withdrawal syndrome, feeling hot and cold, chills, coma, convulsive disorders, raised intracranial Skin rash, blood dyscrasias, thrombocytopenia and asthenic conditions, altered mood and personality pressure. Paralytic ileus. agranulocytosis. Pancreatitis very rarely. change, decreased activity, psychomotor B Hypothyroidism, renal and chronic hyperactivity, agitation, nervousness, insomnia, hepatic disease. Elderly. Shock, adrenocortical SYNDOL SSL Healthcare abnormal thinking, confusion, sedation, dizziness, insufficiency. syncope, paraesthesia, dyspnoea, urinary retention, 2 C MAOIs, CNS depressants, dysuria, micturition urgency. Compound analgesic/antihistamine. Paracetamol phenothiazines, anaesthetics, hypnotics, alcohol. 450mg, codeine (phos.) 10mg, doxylamine A Tolerance, dependence. Constipation, TEEDEX Ricesteele (succinate) 5mg, caffeine 30mg. Yellow scored tab. nausea, vomiting. 2K marked S. 10, A2.53; 20, A3.93. Analgesic/antihistamine. Paracetamol 120mg, SOLPADEINE GSK S Tension headache. Relief of pain diphenhydramine (HCl) 12.5mg per 5ml. Clear red following surgical and dental operation and 2 oral soln with raspberry odour. 100ml, A2.98. procedures. SOLPADEINE SOLUBLE TABLETS Compound S Teething pains, irritability associated P 1-2 tabs. 4 to 6 hourly. Max. 8 tabs. in with injections or feverishness, aches or pains, analgesic. Paracetamol 500mg, codeine phos. 8mg, 24 hours. colds and flu, associated sleeplessness. See Dozol caffeine 30mg. White effervescent tab. 12, A2.46; Q Under 12 years, not recommended. in same section for prescribing information. 24, A4.04; (GMS) 60, A6.89. B Do not take other paracetamol P 2, three or four times daily in water. containing products. Not to be taken continuously TEGRETOL Novartis Q Under 7 years, not recommended. 7-12 over long periods. years, v-1, three or four times daily. 2MO C Alcohol. 2O A Drowsiness, constipation. Dibenzazepine. Carbamazepine 100mg white
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Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA A34.79. S Treatment and prevention of moderate to severe pain. P Depending on severity of pain. Usual initial dose one 100mg tab. twice daily, morning and evening. May be increased to one 150mg or one 200mg twice daily. Swallowed whole. Total daily dose of q 400mg not usually required. 2MO Q Under 12 years, not recommended. ALSO TEGRETOL ORAL SUSPENSION D Pregnancy (unless benefit outweighs Carbamazepine 100mg/5ml. Sugar-free liquid. risk), lactation. Severe renal impairment (ccQ10ml/ 300ml, A7.27. S Trigeminal neuralgia and other forms of min). B Caution: Head injury, increased deafferentation pain. intracranial pressure, severe hepatic impairment, P Initially 100mg once or twice daily increasing gradually to control, usually 600-800mg biliary tract disorders, patients prone to convulsions or in shock, respiratory depression. daily. Max. 1.6g daily. Contains lactose. Not suitable as a substitute in Q Not applicable. opiate-dependent patients. Driving/operating 2MO machines. ALSO TEGRETOL RETARD Carbamazepine 200mg C Acute intoxication with alcohol or other beige-orange cap.-shaped scored controlledCNS agents, MAOIs (or within 2 weeks of release Divitab marked H/C one side and C/G on reverse; 400mg brown-orange cap.-shaped scored withdrawal), under general anaesthesia. Caution: controlled-release Divitab marked CG/CG one side CNS depressants, antipsychotics known to induce and ENE/ENE on reverse. 200mg-50, A4.76; 400mg- convulsions, TCAs, SSRIs, carbamazepine, cimetidine. 50, A9.37. A Nausea, vomiting, dry mouth, dizziness, P Same total daily dose as above but in drowsiness, sweating, headache, flushing, fatigue, two divided doses. dependence. Q Not applicable. D AV conduction abnormalities unless TRAMAKE Galen paced. 2NO B Severe cardiac disease, renal or hepatic impairment. Perform liver function tests Opiate analogue. Tramadol (HCl) 50mg, 100mg. periodically. Blood dyscrasias. Pregnancy, lactation. White scored tabs. marked T50 or TRAMAKE 100. Test blood regularly. 50mg-100, A14.20. 100mg-60, A17.05. C MAOIs, anticoagulants, antiepileptics, S Treatment and prevention of severe lithium, macrolide antibiotics (erythromycin), some pain. Ca++ antagonists (verapamil, diltiazem), P 50-100mg 4-6 hourly. Max. 400mg daily. dextropropoxyphene, viloxazine, cimetidine, Q Not recommended. isoniazid, oral contraceptives, alcohol. D Pregnancy, lactation. A Gastric upset, diplopia, dry mouth, B Elderly. Severe renal or hepatic drowsiness and dizziness. Oedema and impairment. Head injury, raised intracranial hyponatraemia. Blood dyscrasias, rashes, acute pressure. Previous history of convulsions. renal failure, hepatitis. See SPC. Respiratory depression. C Alcohol, CNS depressants, MAOIs, TRADOL Rowex carbamazepine. 2NO A Nausea, vomiting, dry mouth, drowsiness, fatigue, dizziness, rash, diaphoresis, Opiate analgesic. Tramadol (HCl) 50mg. Green/ hallucinations, confusion, headache. Rarely, yellow cap. 100, A12.10. cardiovascular effects, respiratory depression, 2NO convulsions, dependence, dysphoria, blood ALSO TRADOL EFFERVESCENT Tramadol (HCI) dyscrasias. A 50mg. White scored effervescent tab. 50, 9.44. P Depending on severity of pain, initially TRAMAPINE Pinewood 50-100mg followed by 50-100mg at 4-6 hrly 2NO intervals. Acute pain, initially 100mg. Chronic conditions, initially 50mg. Max. 400mg daily. Opiate analgesic. Tramadol (HCl) 50mg. Green/ Q 1-14 years, 1-2mg/kg body weight at 4-6 yellow, hard gelatin cap. marked TRA 50. 100, hrly intervals. A12.96. 2NO S Management (treatment and ALSO TRADOL INJECTION Tramadol (HCI) 50mg/ prevention) of severe pain. ml, 50mg/2ml. Amps. 50mg/ml-5, A2.16; 100mg/ P Depending on the severity of the pain, A 2ml-5, 4.32. initial dose 50-100mg every 4-6 hours. Acute pain, initial dose 100mg. Chronic conditions, initial dose P Usually initial bolus of 100mg by IM or 50mg. Max. daily dose 400mg. slow IV inj. followed by 50-100mg at 4-6 hrly Q Under 1 year, not recommended. 1-14 intervals. Total daily dose q 400mg not usually years, 1-2mg/kg body weight at 4-6 hourly. required. Max. 600mg. May be diluted in soln. or 2NO admin by inf. or Patient Controlled Analgesia (PCA). ALSO TRAMAPINE PROLONGED RELEASE Q See lit. Tramadol (HCI) 100mg. Prolonged-release off2NO white, round biconvex tab. 60, A16.73. ALSO TRADOL SR PROLONGED RELEASE Tramadol P Initially 100mg twice daily morning and (HCl) 100mg, 150mg, 200mg. Flat, round, evening. May be titrated up to 150 or 200mg prolonged release bi-layer tab. Initial layer white; twice daily if necessary. Leave a min. interval of 8 slow release layer green; marked TR over strength. hours between admin. No more than 2 doses in 24 100mg-60, A17.37; 150mg-60, A26.09; 200mg-60, hours. Max. 400mg daily. Swallow tab. whole with
scored tab. marked B/W on one side and GEIGY on reverse; 200mg white scored tab. Marked C/G on one side and G/K on reverse; 400mg white oblong tab. scored and marked CG/CG one side and scored with tab. name on reverse. 100mg-100, A4.16. 200mg-100, A7.69. 400mg-50, A7.57; 400mg-56, A8.47.
PAIN,
PYREXIA
4.1
sufficient liquid. R As per adults. Over 75 years, elimination may be prolonged. Q Under 12 years, not recommended. D Uncontrolled epilepsy. Pregnancy, lactation. B Opiate dependent patients, head injury, shock, decreased level of consciousness of unknown origin, respiratory disturbances, increased intracranial pressure, moderate-severe impaired liver/kidney function. History of epilepsy or those susceptible to seizures. Drug dependence may occur. Not suitable as a substitute in opiatedependent patients. Long-term treatment. Driving or operating machinery. Tramapine 50mg contains lactose. C Contra: Use in cases of acute intoxication with alcohol or other CNS drugs, use with MAOIs (or within 2 weeks of withdrawal). Not recommended: Mixed agonists/antagonists. Caution: Carbamazepine, SSRIs, TCAs, antipsychotics and other seizure threshold lowering drugs known to cause convulsions, coumarin derivatives, ondansetron, prolonged co-admin. with cimetidine. A Dizziness, headache, drowsiness, nausea, vomiting, constipation, dry mouth, sweating, fatigue.
TRAMIL
Wyeth Healthcare
2K Analgesic/xanthine. Paracetamol 500mg, caffeine 32mg. Yellow/blue cap. marked TRAMIL. 10, A1.35. S Mild to moderate pain, pyrexia. P 1-2 four hourly as necessary. Max. 8 in 24 hours. Q Under 12 years, not recommended. D Children Q12 years. B Renal or hepatic impairment. Do not take with other paracetamol containing products. Do not exceed stated dose. Prolonged use may be harmful. C Cholestyramine. Metoclopramide, domperidone. Warfarin. Chloramphenicol. A Skin rash, GI disturbances, tremor, palpitations. Rarely: Thrombocytopenia purpura, methaemoglobinaemia, agranulocytosis.
TRANSTEC
Mundipharma
0LO Opiate. Buprenorphine 35mch/hour, 52.5mcg/hour, 70mcg/hour over a period of 96 hours. Transdermal patches. 35mcg/hour-4, A39.73; 52.5mcg/hour-4, A59.60; 70mcg/hour-4, A79.46. S Moderate to severe cancer pain and severe pain that does not respond to non-opioid analgesics. P The lowest dose providing adequate pain relief should be given. Initially 35mcg/hour and titrate individully replacing every 96 hours. Patients requiring a suppl.ary analgesic may take 1-2 x 0.2mg buprenorphine sublingual tabs. every 24 hours in addition to the patch. Q Under 18 years, not recommended. D Opioid dependence, severe respiratory impairment, MAOIs, myasthenia gravis, delirium tremens. Pregnancy, lactation. B Alcohol intoxication, impaired respiratory function, hepatic impairment. Ability to operate machinery may be impaired. C MAOIs, CNS depressants. A Nausea, dizziness, tiredness, vomiting, constipation, diaphoresis, dyspnoea, erythema,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
147
4.2 MIGRAINE
ANALGESIA pressure, severely impaired liver or kidney function, convulsive disorders, respiratory
pruritus, headache.
TYLEX
UCB depression or shock. Avoid during light planes of
2NO Compound analgesic. Paracetamol 500mg, codeine phos. 30mg. White/red cap. marked C30. 24, A2.30; 100, A9.57.
2NO ALSO TYLEX EFFERVESCENT Paracetamol 500mg, codeine phos. 30mg. White efferv. tab. 90, A9.38. S Moderate to severe pain. P 1 or 2 every four hours; max. 8 daily. Q Not recommended. B Head injury, raised intracranial pressure, renal or hepatic impairment, hypothyroidism, BPH, inflammatory or obstructive bowel disease. Elderly. Labour. Pregnancy, lactation. Patients on salt restriction. C Alcohol or CNS depressants may increase any sedative effect. A Dependence, constipation, dizziness, sedation, nausea, allergic reactions.
general anaesthesia. Driving or operating machinery, if drowsiness occurs. Pregnancy (unless benefit outweighs risk). C Contra: Use in cases of acute intoxication with alcohol or other centrally acting drugs, use with MAOIs (or within 2 weeks of withdrawal). Caution: Carbamazepine, antipsychotics known to induce convulsions, prolonged use with cimetidine. A Nausea, sedation, dizziness, vomiting, headache, diaphoresis, skin rash, dry mouth.
Opiate analogue. Tramadol (HCl) 50mg, 100mg, 150mg, 200mg. Yellow, white, peach and orange film-ctd sust.-release tabs. marked T0, T1, T2 or T3, and with logo. 50mg-60, A4.61; 100mg-60, A10.45; 150mg-60, A15.67; 200mg-60, A20.89. S Treatment of moderate to severe pain. P 50-100mg twice daily morning and evening. If necessary titrate to 150mg or 200mg twice daily. Max. 400mg daily. Q Over 12 years, as per adults; under 12 years, not recommended.
2NO
ALSO ZYDOL CAPSULES Tramadol (HCl) 50mg Green/yellow cap. 100, A7.80. S Treatment of moderate to severe pain. ZAMADOL SR Meda P Initially 1 or 2 caps., then 1 or 2 not more frequently than four hourly; max. 8 daily. 2MO Q Under 1 year, not recommended; over 1 Opiate analogue. Tramadol (HCl) 50mg, 100mg, 150mg, 200mg. Hard prolonged release caps. Dark year, see below. 2 NO green marked T50SR, white marked T100SR, dark green marked T150SR and yellow marked T200SR ALSO ZYDOL INJECTION Tramadol (HCl) 50mg/ml. resp. 50mg-60, A10.17; 100mg-60, A19.38; 150mg- 2ml amp. 5 x 2ml, A3.74. 60, A29.08; 200mg-60, A38.76. S Treatment of moderate to severe pain. VEGANIN PLUS Chefaro S Severe pain. P 50-100mg by IM or IV inj. 4 to 6 hourly; P Initially, 50-100mg twice daily; may be max. 600mg daily. 2 titrated up to 150-200mg twice daily. Max. 400mg. Q Q1 year, not recommended; q1 year, 1Compound analgesic. Paracetamol 500mg, codeine Treatment should be short and intermittent 2mg/kg body weight every 4-6 hours. phos. 8mg, caffeine 30mg. White, film-ctd. cap.(dependence). 2NO shaped tab. debossed on one side with PCC. 10, R Over 75 years, adjust dosage. ALSO ZYDOL XL Tramadol (HCl) 150mg. White A1.92; 20, A3.28. Q Under 12 years, not recommended. Over prolonged release, film-ctd tab., marked T 150. 30, S Mild to moderate pain, rheumatism, 12 years, as per adults. A17.61. dysmenorrhoea, symptomatic relief of colds and 2MO S Management (treatment and influenza. P 2 with water every 4-6 hours. Max. 8 in ALSO ZAMADOL CAPSULES Tramadol (HCl) 50mg. prevention) of severe pain. White, opaque, oblong hard gel. cap. marked T50. P 1 tab. daily, increase if necessary. Take 24 hours. 50mg-100, A12.16. at 24-hourly intervals and swallow whole. Over Q Under 12 years, not recommended. S Treatment and prevention of severe 400mg daily, not usually required. D Acute asthma, respiratory depression, Q Over 12 years: As per adults. Under 12 acute alcoholism, head injuries, raised intracranial pain. P Acute pain: Initially 100mg then 50mg years: Not recommended. pressure, biliary tract surgery. or 100mg r 4 hours apart. Duration should be D Epilepsy not adequately controlled by B Severe renal/hepatic impairment. matched to clinical need. Pain associated with treatment. Not for use in narcotic withdrawal Elderly. Prostatic hypertrophy, inflammatory or chronic conditions: Initially 50mg, then titrate treatment. Pregnancy, lactation. obstructive bowel disorders. according to pain severity. Regularly assess need C CNS depressants, metoclopramide, B May cause physical dependence. Not a for continued treatment. Max. 400mg daily. Severe domperidone, cholestyramine, warfarin, substitute in opioid-dependent patients. History of hepatic impairment/renal insufficiency (ccQ30 ml/ addiction or dependence. Hypersensitivity to anticonvulsants, oral contraceptives, alcohol, min): 12 hourly. barbiturates, MAOIs (or within 2 weeks of codeine, respiratory depression. Head injuries, treatment cessation), antidiarrhoeal/antiperistaltic R Over 75 years, adjust dosage. raised intra-cranial pressure, severe hepatic or Q Under 14 years, not recommended. Over agents, antimuscarinics, quinidine, mexiletine, renal impairment, in shock, epilepsy or patients 14 years, as per adults. cimetidine. prone to convulsive disorders. Contains lactose. D Uncontrolled epilepsy, narcotic A Skin rash, constipation, drowsiness, Driving, using machines. withdrawal treatment. Pregnancy, lactation. headache, tremor, nervousness, irritability. C Contra: MAOIs (or within 2 weeks), B Tendency to drug abuse or dependence. other centrally acting drugs, including alcohol. XYMEL 50 Clonmel Can induce convulsions. History of epilepsy or Caution: SSRIs, TCAs, carbamazepine, antipatients susceptible to seizures; only if essential. psychotics, ritonavir, digoxin, other morphine 2NO Hypersensitivity to opiates. Renal/hepatic derivatives, benzodiazepines, barbiturates, mixed Opiate analogue. Tramadol (HCl) 50mg. Green/ impairment (not recommended if severe), head agonists/ antagonists, anticoagulants, lithium, 5HT yellow cap. marked TRA 50. 100, A11.13. injury, decreased level of consciousness, increased or NA potentiating anti-depressants. S Management (treatment and intracranial pressure, shock, respiratory depression, A Dizziness, headache, somnolence, prevention) of severe pain. P 1-2 four to six hourly. Max. 400mg daily. excessive bronchial secretion. Mild anaesthesia, not sweating, nausea, vomiting, dry mouth, recommended. Driving/using machines. constipation, fatigue. Q Under 1 year, not recommended; 1-14 C Contra: Acute intoxication with years, 1-2mg/kg body weight four to six hourly. 4.2 MIGRAINE hypnotics, centrally acting analgesics, opioids, 2NO psychotropic drugs, alcohol; MAOIs (within 2 ALSO XYMEL PROLONGED RELEASE TABLET BETA-PROGRANE Tillomed weeks). Mixed agonist-antagonists, eg. Tramadol (HCl) 100mg. Prolonged-release white, buprenorphine, nalbuphine, pentazocine (avoid). 3MO round, film ctd tab. 60, A16.32. Caution: CNS depressants, SSRIs, TCAs, antiNon-cardioselective b-blocker. Propranolol (HCl) P Initially 100mg twice daily morning and psychotics, other seizure threshold lowering drugs, 80mg, 160mg. White hard prolonged.-release cap. evening. May titrate up to 150 or 200mg twice carbamazepine, courmarin derivatives. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)daily if necessary. Doses q 400mg daily, not A Fatigue, dizziness, headache, confusion, 28, A6.27. usually required. Swallow tab. whole with GI disorders, pruritis, urticaria, skin rashes, sufficient liquid. S Prophylaxis of migraine. hallucinations, dysphoria, dependence, abuse, Q Under 12 years, not recommended. P 80mg every morning or evening; may withdrawal reactions. D Lactation. be increased if necessary to 160mg daily up to B Drug dependence may occur. Not 240mg daily. ZYDOL SR Grunenthal Pharma suitable as a substitute in opioid-dependent Q Not recommended. 2NO patients. Head injury, increased intracranial D See 2.4, b-blockers Drug Presc. Notes.
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Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA BETALOC
MIGRAINE 4.2 AstraZeneca
3MO Cardioselective b-blocker. Metoprolol tartrate. 50mg white tab. scored and marked A/BB one side; 100mg white tab. scored and marked A/ME one side. 50mg-100, A2.11; 100mg-100, A3.91. S Migraine prophylaxis. P 100-200mg daily in divided doses. (Morning and evening). Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
nostril at onset of attack; 10mg effective in some patients. If migraine recurs in patients who respond, repeat dose at minimum interval of 2 hours. Max. 40mg in 24 hours (in 2 x 20mg doses). Patients who fail to respond initially should not receive a second dose for same attack. W Not recommended.
2MO
ALSO IMIGRAN FTAB Sumatriptan (succinate) 50mg, 100mg. Pink or white triangular shaped film-ctd tabs. marked with GS 1YM and 50 or GS YE7 and 100 resp. 50mg-2, A9.77; 6, A29.29; 100mg-2, A17.23; 6, A51.68. DIXARIT Boehringer Ing. P Single 50-100mg dose at onset of 2MO attack. Patients who do not respond should not Central a-agonist. Clonidine (HCl) 25mcg. Blue sug- take 2nd dose for same attack. If symptoms recur in patients who respond, repeat dose after min. 2 ctd tab. 112, A7.85. hrs. Max. 300mg in 24 hours. S Prophylaxis of migraine or recurrent W Over 65 years or under 18 years, not vascular headache. Menopausal flushing. recommended. P 2-3 morning and evening. D Ischaemic heart disease, severe hepatic Q Not recommended. impairment, previous myocardial infarction, B Depressive illness. Lactation. coronary vasospasm (Prinzmetal’s angina), C Anti-hypertensives. peripheral vascular disease, history of A Sedation, dry mouth, dizziness, cerebrovascular accident (CVA) or transient sleeplessness. ischaemic attack (TIA), diabetes, uncontrolled FROVEX A. Menarini hypertension. B Hypertension, patients predisposed to 2MO thrombotic episodes (patients receiving HRT), risk 5HT receptor agonist. Frovatriptan (succinate factors for coronary artery disease; assess patients monohydrate) 2.5mg. Biconvex, white film-ctd. before initial therapy. History of epilepsy, hepatic tab. debossed M one side and 2.5 the other. 6or renal impairment. Overuse of acute migraine 2.5mg, A29.50; 2-2.5mg, A9.83. treatments associated with exacerbation of S Acute treatment of headache phase of headache in susceptible patients; withdrawal of migraine attacks, with or without aura. Not for treatment may be necessary. Pregnancy, lactation. prophylaxis. Driving or operating machinery. P All adults, 2.5mg. If migraine recurs after initial relief a second dose of 2.5mg may be C MAOIs, other acute migraine therapies, 5HT re-uptake inhibitors, lithium, ergotamine (all given; interval between doses, 2 hours min. contraindicated). R Over 65 years, insufficient data to A Transient pain, sensation of heaviness, recommend. pressure or tightness, fatigue, dizziness, Q Not recommended. drowsiness, weakness. Increase in BP, flushing, D History of MI, ischaemic heart disease, dyspnoea. coronary vasospasm (Prinzmetal’s angina), peripheral vascular disease, hypertension IMITAG Pinewood (moderate/severe or uncontrolled mild), previous 2MO CVA or TIA, severe hepatic impairment. B Not indicated for hemiplegic, basilar or 5-HT agonist. Sumatriptan (succinate) 50mg, 100mg. Pink/white resp. oval-shaped biconvex ophthalmoplegic migraine. Not for prophylaxis. tabs. 50mg tab. is scored. 50mg-6, A18.46; 100mgCardiac disease, hypertension, predisposition to A32.93. 6, thrombotic episodes (HRT), Pregnancy, lactation. Driving/operating machinery. Hereditary galactose S Acute migraine attacks, with or without aura. intolerance, Lapp lactase deficiency, glucoseP Single 50-100mg dose at onset of galactose malabsorption. attack. Patients who do not respond should not C Other acute migraine therapies, take 2nd dose for same attack. If symptoms recur ergotamine/ergotamine derivatives (incl. in patients who respond, repeat dose 1 or 2 times methysergide), other 5-HT1 receptor antagonists, after min. 2 hrs. Max. 300mg in 24 hours. MildMAOIs, St John’s wort (hypericum perforatum), moderate liver impairment: Consider 25mg-50mg. SSRIs, methylergomatrine, gluvoxamine, oral W Over 65 years or under 18 years, not contraceptives. recommended. A Dizziness, headache, somnolence, D MI, ischemic heart disease (or symptoms/ parasthesia. Nausea, dry mouth, dyspepsia, signs), coronary vasospasm (Prinzmetal’s angina), abdominal pain, skeletal pain. Fatigue, sensation peripheral vascular disease. History of of abnormal temperature, flushing, chest pain, cerebrovascular accident or transient ischemic palpitation, throat tightness. attack. Severe hepatic dysfunction, moderate or IMIGRAN NASAL SPRAY GSK severe hypertension or mild uncontrolled hypertension. 2MO B Not indicated for basilar, hemiplegic or 5-HT agonist. Sumatriptan 10mg, 20mg/0.1ml. ophthalmoplegic migraine. Exclude neurological Single dose nasal spray. 10mg-2, A12.90; 6, conditions. Patients at risk of ischaemic heart A38.48; 20mg-2, A15.39; 6, A46.17. disease (e.g. diabetics, heavy smokers, patients on S Acute migraine attacks, with or without nicotine substitution, postmenopausal women and aura, unresponsive to conventional therapy. Not menq40 with risk factors). History of seizures. to be used prophylactically. Hepatic/renal insufficiency. Hypersensitivity to sulphonamides. Controlled hypertension. Overuse. P Optimal dose, 20mg dose into one
Contains lactose. Pregnancy, lactation. Driving, using machines. C Contra: Ergotamine (take sumatriptan 24 hours after ergotamine and ergotamine 6 hours after sumatriptan) MAOIs. Caution: SSRIs, triptans, lithium, St. John’s Wort. A Tingling, dizziness, drowsiness, transient increase in BP, flushing, nausea, vomiting, sensation of heaviness, pain, heat, pressure or tightness, feelings of weakness, fatigue.
INDERAL LA
AstraZeneca
3MO Non-cardioselective b-blocker. Propranolol (HCl) 160mg. Lavender/pink sust.-release cap. marked INDERAL LA. Lavender/pink hard prolong.-release cap. marked INDERAL LA. 28, A8.41.
3MO ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. Lavender/pink hard prolong.-release cap. marked HALF-INDERAL LA. 28, A6.13. S Migraine prophylaxis. P 80-160mg daily. Max. 240mg daily. Q Not recommended.
3MO ALSO INDERAL TABLETS Propanolol (HCl) 10mg. Pink film-ctd tab. marked Inderal 10. 10mg-100, A1.20. P 40mg two or three times daily. Max. 160mg/day. Q Under 12 years, half adult dose. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.
METOCOR
Rowex
3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg100, A3.50; 100mg-100, A6.50. S Migraine prophylaxis. P 100-200mg daily in divided doses. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
METOP
Gerard
3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; 100mg-100, A6.51. S Migraine prophylaxis. P 100-200mg daily in divided doses. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
MIGRALEVE
McNeil Healthcare
2 Analgesic/antihistamine. Pink tabs: buclizine (HCl) 6.25mg, paracetamol 500mg, codeine phos. 8mg. Yellow tabs: paracetamol 500mg, codeine phos. 8mg. Both film-ctd tabs marked mgE. Duo-pack: 12, A4.88; 24, A8.44; 48, A9.37; Pink: 12, A5.07; 24, A9.31; Yellow: 12, A4.38. S Migraine. P 2 pink tabs. at onset of attack. If symptoms persist 2 yellow tabs. every four hours. Max. 2 pink and 6 yellow in 24 hours. Q Under 10 years, not recommended; 1014 years, half adult dose. B Renal or hepatic impairment. A Drowsiness.
MIGRASTAT
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
Gerard
149
4.2 MIGRAINE
ANALGESIA Cardiac evaluation prior to treatment: Risk factors for ischaemic heart disease incl. heavy smokers or users of nicotine substitution therapy (particularly postmenopausal women and males q 40 years). Serious cardiac events may also occur in the absence of underlying CVD. Discontinue and evaluate if symptoms indicating ischaemic heart disease occur. Sulphonamide sensitivity. Contains lactose. C Contra (within 24h): Ergotamine, derivatives of ergotamine (incl. methysergide) and any triptan/5-HT1 receptor agonist. Caution: Renally secreted substances, SSRIs, SNRIs, triptans, St John’s Wort. A Tingling sensation, dizziness, drowsiness, nausea, vomiting, heat sensation, malaise/fatigue.
heart disease, including ischaemic heart disease (angina pectoris, previous MI or confirmed silent ischaemia), objective or subjective symptoms of ischaemic heart disease or Prinzmetal’s angina. Significant arrhythmias or heart failure. Peripheral vascular disease. History of cerebrovascular accident or transient ischaemic attack. B Use only if clear migraine diagnosis established. Not indicated: Hemiplegic, ophthalmoplegic, or basilar migraine. Not for treating atypical headaches (related to possibly serious condition where cerebrovascular vasoconstriction may be harmful). May occur: Chest pain and tightness, (may be intense and involving throat); if symptoms indicate ischaemic heart disease, no further dose should be taken; carry out appropriate evaluation. Not to be given PARAMAX sanofi-aventis without prior evaluation if unrecognised cardiac disease likely, or in patient at risk of coronary 2MO artery disease. Slight and transient increases in BP Analgesic/anti-emetic. Paracetamol 500mg, may occur at doses q60mg (esp. renally impaired metoclopramide (HCl) 5mg. White round scored and elderly). Excessive use of any anti-migraine tab. marked PARAMAX. 14, A1.44. S Symptoms of pain, nausea and vomiting medicine can lead to daily chronic headaches requiring therapeutic window. Contains lactose associated with a migraine attack. and sunset yellow. P Over 20 yrs: 2 tabs. at onset of C Contra: Potent CYP3A4 inhibitors; migraine, thereafter 2 tabs at 4-hourly intervals (max 6 in 24-hrs). 15-20 yrs: 1-2 at onset (max 5 in ergotamine or its derivatives (including 24 hrs). Severe renal impairment: Reduce to 1/3 of methysergide) within 24 hours before or after treatment; other 5-HT1 receptor agonists. Caution: usual daily dose. Moderate renal impairment/ SSRIs, SNRIs, St. John’s wort. severe hepatic impairment: Reduce to v of usual A Pharyngitis, rhinitis, somnolence, daily dose. headache, dizziness, tingling or abnormal Q 12-14 yrs: 1 tab. at onset of migraine (max 3 in 24 hrs). Under 12 yrs, not recommended. sensation, hypertonia, hypoaesthesia, myasthenia, vertigo, palpitation, tachycardia, flushing, throat tightness, abdominal pain, nausea, dry mouth, D Gastro-intestinal haemorrhage, dyspepsia, sweating, back pain, myalgia, sensation obstruction or perforation. Post-operative period. of warmth, asthenia, chest symptoms (pain, History of neuroleptic or metoclopramide induced tightness, pressure), chills. tardive dyskinesia. Epilepsy. Phaeochromocytoma. B Parkinson’s disease, history of atopy SANOMIGRAN Novartis (incl. asthma), porphyria. Neuroleptic Malignant NARAMERG Teva 2MO Syndrome. Extrapyramidal disorders. Severe 2MO 5-HT antagonist. Pizotifen (as hydrogen malate) impaired renal or hepatic function. 0.5mg ivory/yellow sug-ctd tab. marked SMG; 5-HT receptor agonist. Naratriptan 2.5mg (as HCl) Methemoglobinemia. 1.5mg ivory/yellow sug-ctd tab. marked SMG and Green, biconvex, round, film-ctd tab. debossed C Contra: Levodopa. Alcohol, A A 1.5. 0.5mg-60, A5.25; 1.5mg-28, A8.76. with NT 2.5 on one side. 6, 26.40; 12, 52.80. chloramphenicol, oral contraceptives, S Acute treatment of headache phase of domeperidone, colestyramine, warfarin/coumarins, D Pregnancy, lactation. B Epilepsy. Glaucoma. Urinary retention. migraine attacks with or without aura. anticholinergics, CNS depressants, neuroleptics, C MAOIs, CNS depressants, alcohol. P 1 tab. To be taken as early as possible digoxin, cyclosporine. Avoid other paracetamol A Drowsiness, weight gain. Dizziness, dry after onset of migraine headache, but effective if containing products. mouth, nausea, constipation. CNS stimulation in taken at later stage. If symptoms recur following A Extrapyramidal reactions. Drowsiness, children. initial response, a 2nd dose may be taken confusion, hallucination. Skin rash. Asthenia. (minimum 4-hour interval between doses). Max: 2 Anxiety, depression. Diarrhoea. Amenorrhea, SIBELIUM Janssen-Cilag tab. in any 24-hour period. If patient does not galactorrhea, gynaecomastia. respond to 1st dose, a 2nd dose should not be 2MO taken for same attack. Subsequent migraine RELPAX Pfizer Selective Ca++ entry blocker. Flunarizine 5mg. Dark attacks may be treated. Not for prophylactic use. grey body with red cap. 20, A10.41. 2MO Mild-moderate renal/hepatic impairment, S Prophylaxis and treatment of migraine. 5-HT receptor agonist. Eletriptan 40mg (as maximum total daily dose: 1 tab. P 1 twice daily or 2 at bedtime. Elderly, 1 hydrobromide). Round, convex, orange film-ctd R Over 65 years, not recommended. tab. debossed with REP 40 one side and Pfizer the at night. Q Not recommended. Q Not recommended. other. 6, A27.34. D Previous MI, ischaemic heart disease, S Acute treatment of the headache phase D Patients with current depressive illness Prinzmetal’s angina/coronary vasospasm, or with a history of recurrent depression. of migraine attacks, with or without aura. peripheral vascular disease, symptoms or signs Pregnancy. consistent with ischaemic heart disease. History of P Initially, 40mg. If headache recurs within B Drowsiness may occur, and patients 24 hours, repeat dose at minimum interval of 2 cerebrovascular accident or transient ischaemic should not drive or operate machinery. hours. Non responsive patients should not take attack. Moderate or severe hypertension, mild C Antihypertensives. uncontrolled hypertension. Severely impaired renal 2nd dose for same attack. If no satisfactory efficacy obtained after appropriate trial of 40mg, A Fatigue. Rarely depression and (cc Q15 ml/min) or hepatic function (Child-Pugh extrapyramidal reactions. 80mg dose (2 x 40mg) may be taken for grade C). Pregnancy (unless benefit outweighs subsequent attacks. Max daily dose: 80mg. risk), lactation (avoid for 24h). SUMATRAN Rowex R Over 65 years, not recommended. B Use only with a clear diagnosis of 2MO Q Not recommended. migraine. Not indicated for hemiplegic, basilar or D Severe hepatic/renal impairment. 5-HT agonist. Sumatriptan (succinate) 50mg, ophthalmoplegic migraine. Exclude other 100mg. Pink/white resp. biconvex oblong scored potentially serious neurological conditions. Safety Moderately severe or severe hypertension, or and efficacy during aura phase not established. untreated mild hypertension. Confirmed coronary tab. 50mg-2, A6.15; 50mg-6, A18.45; 100mg-2,
2MO
5-HT agonist. Sumatriptan (succinate) 50mg, 100mg. Pink/white resp. round tab. marked SU50 or SU100 on one side and G on reverse. 50mg-2, A6.16; 100mg-2, A10.98. S Acute migraine attacks (with or without aura) including menstrually associated migraine. P Single 50-100mg dose at onset of attack. Patients who do not respond should not take 2nd dose for same attack. If symptoms recur in patients who respond, repeat dose 1 or 2 times after min. 2 hrs. Max. 300mg in 24 hrs. W Over 65 years or under 18 years, not recommended. D Severe hepatic impairment, ischaemic heart disease, previous MI. Coronary vasospasm (Prinzmetal’s disease), peripheral vascular disease, diabetics, uncontrolled hypertension. History of cerebrovascular accident or transient ischaemic attack (TIA). B Not indicated for basilar or hemiplegic/ ophthalmoplegic migraine. Exclude neurological conditions. Migraine patients are at higher risk of stroke and TIA. Underlying cardiac disorders; patients at risk of coronary artery disease or thrombotic episodes. Symptoms consistent with angina, interrupt until further investigated. Caution: Controlled hypertension, hepatic/renal impairment. History of seizures. Hypersensitivity to sulphonamides. Contains lactose. Pregnancy, lactation. Driving/using machines. C Contra: Ergotamine (take sumatriptan 24 hrs after ergotamine and ergotamine 6 hrs after sumatriptan) MAOIs. Caution: SSRIs, lithium, triptans, St. John’s Wort, HRT. A Tingling, dizziness, increases in BP, flushing, nausea, vomiting, sensations of heaviness/heat, pain, pressure or tightness, weakness, fatigue.
150
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY A10.97;
PAIN
100mg-6, A32.90. S Acute migraine attacks, with or without aura. P Single 50-100mg dose at onset of attack. Patients who do not respond should not take 2nd dose for same attack. If symptoms recur in patients who respond, repeat dose 1 or 2 times after min. 2 hrs. Max. 300mg in 24 hours. W Over 65 years or under 18 years, not recommended. D Ischaemic heart disease, severe hepatic impairment, previous MI, coronary vasospasm (Prinzmetal’s angina), peripheral vascular disease, history of cerebrovascular accident or transient ischaemic attack, uncontrolled hypertension. B Not indicated for basilar, hemiplegic/ ophthalmoplegic migraine. Exclude neurological conditions. Patients at risk of ischaemic heart disease (e.g. diabetics, heavy smokers, patients on nicotine substitution, postmenopausal women and menq40 with risk factors). History of seizures. Hepatic/renal insufficiency. Contains lactose. Pregnancy, lactation. Driving, using machines. C Contra: Ergotamine (take sumatriptan 24 hours after ergotamine and ergotamine 6 hours after sumatriptan) MAOIs. Caution: SSRIs, lithium, triptans, St. John’s Wort. A Tingling, dizziness, increases in BP, flushing, nausea, vomiting, sensations of heaviness/heat, pain, pressure or tightness, weakness, fatigue, somnolence.
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
parathesia, somnolence, amnesia, balance disorder, cognitive disorder, convulsion, abnormal coordination, attention disturbance, dysarthria, dysgeusia, hypoaesthesia, intention tremor, lethargy, memory impairment, mental impairment, nystagmus, impaired psychomotor skills, sedation, tremor, diplopia, blurred vision, visual disturbance, ear pain, tinnitus, vertigo, dyspnoea, epistaxis, nasal congestion, rhinorrhoea, GI disorders, dysuria, nephrolithiasis, pollakiuria, alopecia, pruritus, rash, arthralgia, muscle spasms, muscle twitching, muscular weakness, musculoskeletal chest pain, myalgia, hypersensitivity, fatigue, asthenia, abnormal feeling, gait disturbance, irritability, malaise, pyrexia, weight decreased/ increased.
5.1
D Aspirin/NSAID induced allergies. Peptic ulcer, other GI disorders. Pregnancy (1st and 3rd trimester). B Asthma, cardiac/renal/hepatic insufficiency. Elderly. C Other analgesics. Caution: Oralanticoagulants, thiazide diuretics. A GI disturbances. Rash, pruritus. Easy bruising or bleeding. Abnormal liver function tests.
ARCOXIA
MSD
2MO
COX-2 inhibitor. Etoricoxib 30mg blue-green, 60mg dark green; 90mg white; 120mg pale green tabs. All apple-shaped film-ctd tab. marked ACX 30, ARCOXIA 60, ARCOXIA 90 and ARCOXIA 120 ZOMIG AstraZeneca resp. one side and coded 101, 200, 202 and 204 2MO resp. on reverse. 30mg-28, A29.68; 60mg, 90mg28, A31.49; 120mg-7, A7.88; 28, A31.49. 5HT1 agonist. Zolmitriptan 2.5mg. Yellow film-ctd tab. 3, A14.62; 6, A29.26. S Symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing 2MO spondylitis (AS). ALSO ZOMIG RAPIMELT Zolmitriptan 2.5mg. White, round, orodispersible tab marked Z on one P OA: 30mg once daily up to 60mg once daily. RA and AS: 90mg once daily. Hepatic A A side with a bevelled edge. 2, 9.76; 6, 29.26. insufficiency: mild, max. 60mg once daily; S Acute treatment of migraine headache moderate, max. 60mg every other day. with or without aura. Q Under 16 years, not recommended. P Initially 2.5mg as soon as possible after D Active peptic ulceration or GI bleeding, the onset of an attack. If symptoms persist or return, a repeat dose may be given at an interval severe hepatic / severe renal dysfunction, IBD, severe CHF. Aspirin/ant-inflammatory induced of at least 2 hrs. If the response is inadequate, asthma or allergies. Pregnancy or women TOPAMAX Janssen-Cilag increase to 5mg for subsequent attacks. Max. 10mg daily. Severe hepatic impairment, max. 5mg attempting to conceive, lactation. 2MO in 24 hours. B Renal or hepatic impairment. History of Sulphamate. Topiramate 25mg, 50mg, 100mg, R Over 65 years, not recommended. ischaemic heart disease, cardiac failure, LV 200mg. White, light yellow, yellow or salmon film- Q Under 18 years, not recommended. dysfunction, hypertension, pre-existing oedema. ctd tabs marked with TOP and tab. strength. D Uncontrolled hypertension, MI, History of GI perforation. Elderly. Dehydration. 25mg-60, A26.55; 50mg-60, A43.62; 100mg-60, Prinzmetal’s angina, ischaemic heart disease or Monitor patients on anticoagulants. A77.85; 200mg-60, A146.35. peripheral vascular disease; concomitant admin. of C Caution: Diuretics, ACE inhibitors, AIIAs, 2MO ergotamine and other 5HT agonists; history of cyclosporin, tacrolimus, lithium, rifampicin, oral ALSO TOPAMAX SPRINKLE Topiramate 15mg, cerebrovascular accident or transient ischaemic contraceptives, HRT, oral anticoagulants, high dose 25mg. Sprinkle cap. 15mg-60, A22.44; 25mg-60, attack; cc q15ml/min. aspirin or other NSAIDs (avoid), methotrexate, A33.65. B Exclude serious neurological conditions; digoxin, salbutamol, minoxidil. S Migraine prophylaxis in adult patients Wolff-Parkinson-White syndrome; phenylketonuria A Dizziness, headache, GI disorders, intolerant of or unresponsive to other migraine (Rapimelt only). Prolonged use. Pregnancy, oedema, hypertension, asthenia/fatigue, flu-like treatments. lactation. Tab contains lactose. Orodispersible tab disease. P Initially 25mg daily for 1 week, then contains aspartame. increased by 25mg/day at 1-week intervals. C Ergotamine (interval of min. 24 hrs if ARELOGER Gerard Recommended dose 100mg/day in 2 divided doses. taken together). Caution: Moclobemide, other 2MO Maximum 200mg/day. Tab. should not be broken. MAOIs, cimetidine, fluvoxamine, quinolones. SSRIs, NSAID. Meloxicam 7.5 mg, 15mg. Pale yellow Q Not recommended. SNRIs (serotonine syndrome reported). round tabs. with score line on one side. 7.5mg-30, D Pregnancy (unless benefits outweigh A Abnormalities or disturbances of A7.01; 15mg-30, A9.52. risks), lactation. sensation, dizziness, paraesthesia, somnolence, S Short-term treatment of exacerbations B Caution: Hepatic and moderate to warm sensation, palpitations, abdominal pain, of osteoarthrosis. Long-term treatment of severe renal impairment. Patients at risk of nausea, dry mouth, vomiting, muscle weakness, rheumatoid arthritis (RA) or ankylosing spondylitis nephrolithiasis; maintain adequate hydration. May myalgia, asthenia, heaviness in limbs, chest and (AS). occur: increased incidence of mood disturbances neck; tightness in throat, neck, limbs and chest; P Osteoarthrosis: 7.5mg/day as single dose and depression, acute myopia with secondary pain or pressure in throat, jaw, neck and chest. with water or other liquid during meal; may be angle-closure glaucoma (rare). Monitor serum increased to 15mg/day. RA/AS: 15mg/day; may be 5.1 P AIN AND INFLAMMATION OF bicarbonate; reduce dose or withdraw if metabolic reduced to 7.5mg/day. Max. 15mg/day. Dialysis acidosis develops. Monitor for weight loss. MUSCULO-SKELETAL SYSTEM patients with severe renal failure: 7.5mg/day. Hereditary problems of galactose intolerance, the R 7.5mg/day Lapp lactase deficiency or glucose-galactose ADVIL LIQUIGELS Wyeth Healthcare Q Under 15 years, not recommended. malabsorption. Driving/using machine. Withdraw 2K D Pregnancy, lactation. History of or active gradually. NSAID. Ibuprofen 200mg. Green translucent, oval GI ulcer, severely impaired liver function, nonC Caution: Phenytoin, carbamazepine, soft gelatin cap. marked Advil one side in white dialysed severe renal failure, GI/cerebrovascular digoxin, oral contraceptives, lithium, A ink. 20, 3.20. bleeding or other bleeding disorders, severe hydrochlorothiazide, metformin, pioglitazone, S Mild to moderate pain (rheumatic/ uncontrolled HF. glibenclamide, agents causing nephrolithiasis. muscular pain, backache, headache, dental pain, B History of oesophagitis, gastritis and/or A Nasopharyngitis, anaemia, anorexia, dysmenorrhoea), feverishness, cold and flu peptic ulcer, GI symptoms or history of GI disease. decreased appetite, depression, abnormal symptoms. Bronchial asthma. Elderly, cardiac failure, cirrhosis, behaviour, aggression, agitation, anger, anxiety, nephrotic syndrome or renal failure, major bradyphrenia, confusional state, depressed mood, P 1-2 caps. every 4-6 hours. Max. 6 in 24 hours. surgery; monitor diuresis and renal function. May disorientation, expressive language disorder, insomnia, altered mood, mood swings, dizziness, Q Under 12 years, not recommended. impair women fertility. Contains lactose. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
151
5.1 PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
C Not recommended: Other NSAIDs, lithium, oral anticoagulants. Caution: Thrombolytics and antiplatelet drugs, diuretics, AII receptor antagonists, ACE inhibitors, b-blockers, cyclosporin, intrauterine devices, glucocorticoids, methotrexate, cholestyramine. A Anaemia, lightheadedness, headache, GI disorders, pruritus, rash, oedema.
ARTHRIMEL
Clonmel
2MO Amino-monosaccharide. Glucosamine sulfate NaCl equiv. glucosamine sulfate 500mg. Off-white oblong film-ctd tab. 90, A21.32. S Osteoarthritis of low to moderate degree. P 1 three times daily. Q Under 18 years, not recommended. B Allergy to shellfish. Contain lactose. Severe renal/hepatic insufficiency. Pregnancy (avoid 1st 3 months), lactation; if benefit outweighs risk. C Caution: Hypoglycaemic agents. A Transient GI disorders, heartburn, nausea.
ARTHROTEC 50
Pfizer
2NO Phenylacetic acid/prostaglandin analogue. Diclofenac (Na+) 50mg, misoprostol 200mcg. White tab. marked with symbol one side, Searle 1411 on reverse. 60, A17.15.
2NO ALSO ARTHROTEC 75 Diclofenac (Na+) 75mg, misoprostol 200 mcg. White tab. marked with symbol and Searle 1421. 60, A19.98. S Osteoarthritis and rheumatoid arthritis. P 50mg tab. two or three times daily or 75mg tab. twice daily, both taken with food. Q Not recommended. D Aspirin/anti-inflammatory induced allergy. Active GI bleeding or perforation, other active bleedings (e.g cerebrovascular bleedings). Pregnancy, lactation, women planning a pregnancy. Severe HF. Renal/hepatic failure. Coronary artery bypass graft surgery. B Pre-menopausal women should use effective contraception. Gastroduodenal ulceration, renal, cardiac or hepatic impairment. Monitor patients on long term therapy. Cerebrovascular, coronary or peripheral vascular disease. C Avoid: Other NSAIDs (incl. COX-2 inhibitors). Caution: Oral hypoglycaemics, K+sparing diuretics, steroids, lithium, anticoagulants, methotrexate, ciclosporin, tacrolimus, digoxin, ketoconazole, anti-hypertensives. Not to be taken for 8-12 days after mifepristone. Antacids may delay absorption. A GI upset, erosion. Insomnia, headache, dizziness, erythema multiforme, rash, pruritus, increased blood alkaline phosphatase, increased ALT.
BRUFEN RETARD
Abbott
2MO NSAID. Ibuprofen 800mg. White pillow-shaped, film-ctd sust.-release tab. marked BRUFEN RETARD. 56, A13.89. S Rheumatoid arthritis (incl. Stillâ&#x20AC;&#x2122;s disease), ankylosing spondylitis, osteoarthritis, sero-negative arthropathies, peri-articular disorders, soft tissue injuries. P 2 as a single dose, preferably in the
152
early evening, swallowed whole with plenty of fluid. In severe or acute conditions, max. 3 daily in two divided doses. Q Under 12 years, not recommended.
RHEUMATOLOGY
corticosteroids, diuretics. A Epigastric pain, nausea, headache, dizziness, rash, elevation of liver enzymes.
2MO
CELEBREX
ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta sug-ctd tabs marked BRUFEN 400; magenta oval film-ctd tab. marked BRUFEN 600. 400mg-250, A6.87; 600mg-100, A4.37.
2NO
Pharmacia
Coxib. Celecoxib 100mg, 200mg. Hard opaque white caps. with two blue bands marked 7767 and 100 or two gold bands marked 7767 and 200 resp. 2MO 100mg-60, A26.85; 100mg-100, A44.74; 200mg-30, A26.85; 200mg-100, A89.51. ALSO BRUFEN SYRUP Ibuprofen 100mg/5ml. 200ml, A1.90. S Symptomatic relief in osteoarthritis or P 1200-1800mg daily in three divided rheumatoid arthritis. doses. Max. 2400mg daily. P Osteoarthritis: 200mg once daily or in Q 1-2 years, 2.5ml three or four times two divided doses; 200mg twice daily may be daily; 8-12 years, 10ml three or four times daily. used. Rheumatoid arhtritis: 200-400mg in two (Based on 20mg/kg body weight daily). Dose divided doses. Max. 400mg daily. should not exceed 500mg in twenty four hours for Q Not recommended. children weighing less than 30kg. Juvenile D Active peptic ulceration or GI bleeding, rheumatoid arthritis, up to 40mg/kg body weight IBD, severe CHF, severe hepatic disease, aspirin/ daily in divided doses. anti-inflammatory induced asthma or allergy. D Active peptic ulcer. Patients with estimated cc Q 30ml/min. Pregnancy B Aspirin/anti-inflammatory induced and women of childbearing potential unless using allergy. Asthma. Pregnancy. an effective method of contraception, lactation. C Caution: Antihypertensives, diuretics, Hypersensitivity to sulphonamides. cardiac glycosides, lithium, methotrexate, B Renal or hepatic impairment, cardiac cyclosporin, other NSAIDs, corticosteroids, failure, LV dysfunction hypertension, pre-existing anticoagulants, anti-platelet agents, SSRIs, oedema, risk of hypovolaemia. History of GI quinolone antibiotics, probenacid, oral ulceration or inflammation. Elderly (q 65 years) hypoglycaemics, Ginkgo biloba extracts. and black patients should use lower dose. Advise A Dyspepsia, GI bleeding, rash, rarely women of childbearing age to use effective nonthrombocytopenia. hormonal contraceptive measures. Monitor patients on anticoagulants. CAPRIN Pinewood C Drugs metabolised by CYP2D6 or CYP2C19, diuretics, antihypertensives, ACE 2MO Salicylate. Aspirin 300mg. Pink ent-ctd tab. marked inhibitors, cyclosporin, tacrolimus, lithium, fluconazole, rifampicin, carbamazepine, CAPRIN. 100, A3.72. barbiturates, fluconazole. No data with oral S Rheumatic and associated conditions. contraceptives. P 3 tabs (900mg) 3-4 times daily. A Abdominal pain, diarrhoea, dyspepsia, Q Not recommended. flatulence, dizziness, peripheral oedema, fluid D Active peptic ulceration, coagulation retention, insomnia, pharyngitis, rhinitis, sinusitis, deficiency disorders, lactation. upper respiratory infection, rash. B Reyeâ&#x20AC;&#x2122;s syndrome in children. Avoid: Stroke patients, severe hepatic/renal impairment, DICLAC Rowex history of peptic ulceration or coagulation 2MO abnormalities, dehydration. Pregnancy (avoid at term). Elderly. Phenylacetic acid. Diclofenac (Na+) 25mg, 50mg. Yellow-brown ent-ctd tabs. 25mg-100, A5.37; C Hypoglycaemic agents 50mg-100, A12.92. (esp.sulphonylureas), uricosuric agents, S Musculo-skeletal disorders, rheumatoid methotrexate, antacids, antiepilectic agents arthritis, osteo-arthrosis, ankylosing spondylitis, (phenytoin & Na+ valproate), sulphonamides, acute gout. Chronic juvenile arthritis. antihypertensives, iron salts and alkali. Management of post-operative pain and A Allergic or asthmatic reactions. inflammation in orthopaedic, dental and minor Bronchospasm. surgery. Dysmenorrhoea and associated CATAFLAM Novartis menorrhagia. P 100-150mg daily in divided doses. Max. 2MO total daily dose should not exceed 150mg. Phenylacetic acid. Diclofenac (K+) 25mg, 50mg. Q 1-3mg/kg body weight daily in divided Circular, biconvex, sugar ctd tabs. 25mg pale red; doses. 50mg reddish brown. 25mg-30, A1.90 ; 50mg-30, 2MO A3.69. ALSO DICLAC RETARD 75MG Diclofenac (Na+) S All grades of pain and inflammation 75mg (12.5mg immediate release and 62.5mg incl. acute musculo-skeletal disorders. prolonged release). Two layered, pink and white, P 100-150mg in two or three divided prolonged release tab. 60, A15.35. doses. Max. 150mg daily. Q Under 14 years, not recommended; over P 1-2 daily. 14 years, 75-100mg in two or three divided doses. Q Not applicable. 2MO D Active or suspected peptic ulcer. Asthma, aspirin/anti-inflammatory induced allergy. ALSO DICLAC RETARD 100MG Diclofenac (Na+) 100mg. White, round, prolonged release tab. 30, B Renal, cardiac or hepatic impairment. A10.75. Elderly. Pregnancy, lactation. P 1 once daily. C Lithium, digoxin, anticoagulants, Q Not applicable. antidiabetic agents, cyclosporin, methotrexate, 2MO quinolone antimicrobials, other NSAIDs,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
5.1
hypoglycemic agents, antihypertensives, cardiac glycosides, aminoglycosides, probenecid. A GI disturbances, headache, dizziness, vertigo, rash, elevated liver enzymes.
A GI disorders, headache, dizziness, vertigo, rashes or skin eruptions, raised ALT, AST.
2NO
DIFENE
2MO
ALSO DICLAC INJECTION Diclofenac (Na+) 25mg/ ml. 3ml amp. 10 x 3ml, A5.61. P 75mg IM once or twice daily by deep intragluteal inj. for 2-3 days. Continue if necessary with tabs. or suppos. Q Not applicable. D Active peptic ulcer. Asthma, aspirin/antiinflammatory induced allergy. Last trimester of pregnancy. Severe hepatic, renal, cardiac failure. B History of GI lesions. Renal or hepatic dysfunction. Pregnancy, lactation. Crohn’s, UC, proctitis. May impair female fertility; not recommended in women attempting to conceive. Tabs contain lactose. C Lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, corticosteroids, diuretics, salicylates. A Transient epigastric pain, nausea. Rash, oedema (discontinue). Rare GI bleeding (discontinue), peptic ulcer. Abnormalities of liver and kidney function.
2MO
ALSO DICLAC SUPPOSITORIES Diclofenac (Na+) 100mg. 10, A2.30. P 1 at night alone or in combination with oral admin. Q Not applicable.
DONA
Helsinn Birex
Astellas Amino-monosaccharide. Crystaline glucosamine
Phenylacetic acid. Diclofenac Na+ 25mg, 50mg. Blue/transparent cap. containing ent-ctd pellets, marked D25 and blue/transparent cap. containing ent-ctd pellets, marked D50. 25mg-56, A1.80; 50mg-56, A4.36. S Musculo-skeletal disorders, rheumatoid arthritis, osteo-arthrosis, ankylosing spondylitis, acute gout. Chronic juvenile arthritis. P 75-150mg daily in three divided doses. Max. total daily dose should not exceed 150mg. Q 1-3mg/kg body weight daily in divided doses. Not applicable for gout.
2MO ALSO DIFENE SUPPOSITORIES Diclofenac Na+ 100mg. 10, A1.38. P 1 at night. Q Not applicable.
2MO
ALSO DIFENE 100MG DUAL RELEASE Diclofenac 100mg (25mg rapid release and 75mg sust.-release pellets). Blue/transparent cap. marked D100M. 28, A11.93. DICLO Pinewood S Musculosketal disorders, 2MO dysmenorrhoea, dental and minor surgery. P 1 once daily. Phenylacetic acid. Diclofenac (sodium) 50mg. Tan Q Not applicable. circular biconvex ent.-ctd tab. engraved 50/0519 2MO on one side. 100, A14.41. S Acute musculo-skeletal disorders, ALSO DIFENE RETARD DUAL RELEASE Diclofenac psoriatic arthropathy, low back pain, pain relief in Na+ 75mg. Blue/transparent cap. containing entfractures, rheumatoid arthritis, osteoarthritis, ctd, sust.-release pellets, marked D75M. 56, A17.90. ankylosing spondylitis. Inflammation in orthopaedic, dental, minor surgery. Post-operative S Musculosketal disorders, dysmenorrhoea, dental and minor surgery. pain. P 1 twice daily. P 75-150mg daily in 2-3 divided doses Q Not applicable. swallowed with liquid before meals 2NO Q 1-3mg/kg body weight daily in divided doses. ALSO DIFENE INJECTION Diclofenac Na+ 25mg/ml. 2MO 3ml amp. 10 x 3ml, A3.36. ALSO DICLO 75 PROLONGED RELEASE Diclofenac S Acute back pain, post-operative pain, (sodium) 75mg, prolonged release. Round flat renal colic. two-layered pink and white, prolonged release P 75mg IM once or twice daily by deep A tabs. 75mg Prolonged Release-60, 15.20. intragluteal inj. for max. 2 days. Post operative S Osteoarthritis, pain/inflammation pain: Admin. 75mg IV diluted in 300ml normal associated with musculo-skeletal disorders saline and infuse over min. 30 mins.; a second (rheumatoid arthritis, ankylosing spondylitis, dose can be given 8 hours later; max. 2 inf. in 24 psoriatic arthropathy, periarthritis, tendinitis, hrs. Continue if necessary with tabs. or suppos. tenosynovitis, bursitis). Trauma and post-operative Q Not applicable. pain. Dysmenorrhoea. D History of GI bleeding or perforation, P 1 or 2 tabs. daily, taken whole with related to previous NSAID therapy. Active, or liquid. history of, recurrent peptic ulcer/haemorrhage. Q Not recommended. Aspirin/anti-inflammatory induced allergy. Severe D Active peptic ulcer, GI bleeding. Aspirin/ HF. In ulcerative or acute inflammatory conditions other non steroidal anti-inflammatory induced of the anus, rectum (proctitis) and sigmoid colon. allergy. Pregnancy. B Use lowest effective dose. Elderly. B Renal, severe hepatic or cardiac History of GI disease/toxicity. Risk of GI bleeding, insufficiency. Lactation. Elderly (prolonged use). ulceration or perforation. Risk of hypersensitivity Anaphylactic reactions, discontinue if liver reactions. May mask infection. Serious skin function worsens. Medical surveillance in patients reactions have been reported rarely. Renal, cardiac with symptoms of GI disorders. Caution: or hepatic impairment. Bleeding abnormalities. Intracranial haemorrhage and bleeding diathesis, Long-term use. May impair female fertility; not long term treatment. Avoid driving/operating recommended in women attempting to conceive. machinery if dizziness or other CNS disturbances Pregnancy, lactation. occur. C Lithium, digoxin, anticoagulants, antiC Lithium, digoxin, anticoagulants, platelets, SSRIs, cyclosporin, methotrexate, antidiabetic agents, cyclosporin, methotrexate, quinolones, other NSAIDs and steroids, quinolone antimicrobials, other NSAIDs, corticosteroid, diuretics, cardiac glycosides, anticorticosteroids, diuretics, salicylates, oral hypertensives, aminoglycosides, probenecid.
sulphate 1884mg (equiv. to glucosamine sulphate 1500mg), Na+Cl- 384mg. Sachets-30, A13.13.
2MO ALSO DONA CAPSULES Crystaline glucosamine sulphate 628mg (equiv. to glucosamine sulphate 500mg), Na+Cl- 128mg. Hard gelatine, snap-fit, redred capsules, marked ROTTA on body and head. 90-A13.13. S Symptoms of osteoarthritis, i.e. pain and function limitation. P Dissolve content of one sachet in glass of water, taken once daily, preferably at meal, or one capsule three times daily, preferably at meals. Max. recommended duration 3 years. Q Not recommended. D Lactation, pregnancy (unless benefit outweighs risk, avoid in first trimester). Sachets: Phenylketonuria (contains aspartame). B Impaired glucose tolerance (caution). Closer monitoring of blood sugar levels in diabetics at start of treatment. Severe hepatic / renal insufficiency. Obtained from shellfish (potential allergen). Contains sodium. Sachets contain sorbitol. C Caution: Warfarin, tetracyclines. A Stomach pain, flatulence, diarrhoea, constipation, headache, somnolence, nausea, dyspepsia.
DYNASTAT
Pharmacia
2N COX-2 inhibitor. Parecoxib 40mg per vial. After reconstitution 20mg/ml. Powder for soln for inj. Vials: 1 x 10, A83.28. S Short term treatment of postoperative pain. P 40mg IV or IM, followed every 6-12 hours by 20-40mg as required. Max. 80mg daily. Q Under 18 years, not recommended. D Bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or allergic-type reactions after taking acetylsalicylic acid or NSAIDs or other COX-2 inhibitors. Severe hepatic impairment, active peptic ulceration or GI bleeding, IBD, severe CHF. Women attempting to conceive. Third trimester of pregnancy, lactation. B Impaired renal function, hypertension, compromised cardiac or hepatic function or other conditions predisposing to fluid retention. Moderate hepatic impairment. Caution following CABG surgery. History of upper GI perforations, ulcers or bleeds (PUBS). C Warfarin, diuretics, antihypertensives, ACE inhibitors, cyclosporin, tacrolimus, drug metabolised by CYP2D6 or CYP2C19, lithium, fluconazole, rifampicin, carbamazepine, phenytoin. A Hypertension, hypotension, back pain, peripheral oedema, hypoaesthesia, alveolar osteitis (dry socket), dyspepsia, flatulence, creatinine increase, hypokalaemia, agitation, insomnia, postoperative anaemia, pharyngitis, respiratory insufficiency, pruritus, oliguria.
FELDENE
McNeil Healthcare
2MO NSAID. Piroxicam 10mg, 20mg. Red/blue cap. marked Pfizer and FEL 10. 10mg-30, A4.48; 10mg56, A7.43; 20mg-28; A7.43.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
153
5.1 PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
round tabs. with central breakline on one side. 7.5mg-30, A7.01; 15mg-30, A9.82. S Short-term treatment of exacerbations of osteoarthrosis. Long-term treatment of rheumatoid arthritis or ankylosing spondylitis. P Exacerbations of osteoarthrosis: 7.5mg/ day as single dose with water or other liquid during meal; may be increased to 15mg/day. Rheumatoid arthritis, ankylosing spondylitis: 15mg/ day; may be reduced to 7.5mg/day. Max. 15mg/ day. Dialysis patients with severe renal failure: 7.5mg/day. R 7.5mg/day. Q Under 15 years, not recommended. D Pregnancy, lactation. History of or active GI ulcer, severely impaired liver function, nondialysed severe renal failure, GI/cerebrovascular bleeding or other bleeding disorders, severe uncontrolled HF. B History of oesophagitis, gastritis and/or peptic ulcer, GI symptoms or history of GI disease. Bronchial asthma. Congestive cardiac failure, cirrhosis, nephrotic syndrome or renal failure, major surgery; monitor diuresis and renal function. Elderly. Contains lactose. C Not recommended: Other NSAIDs, lithium, oral anticoagulants. Caution: Thrombolytics and antiplatelet drugs, diuretics, AII receptor antagonists, ACE inhibitors, b-blockers, cyclosporin, intrauterine devices, glucocorticoids, PHARMA NORD methotrexate, cholestyramine. Pharma Nord A Anaemia, lightheadedness, headache, GI disorders, pruritus, rash, oedema.
S Rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute musculo-skeletal disorders, acute gout. Juvenile chronic arthritis. P 20mg daily as a single dose. Acute musculo-skeletal disorders, initially 40mg daily for 2 days then 20mg daily for 7-14 days. Acute gout, initially 40mg as a single dose then 40mg daily in single or divided doses for next 4-6 days. Q Juvenile chronic arthritis (Stillâ&#x20AC;&#x2122;s disease). Less than 15kg body weight, 5mg; 16-25kg body weight, 10mg; 26-45kg body weight, 15mg; over 46kg body weight, 20mg. All as single daily dose. D Aspirin/anti-inflammatory induced allergy. Active peptic ulcer, history of recurrent ulceration. B Impaired renal or hepatic function, elderly. Intracranial haemorrhage and bleeding diathesis. History of upper GI disease. Interstitial nephritis, glomerulonephritis, papillary necrosis and nephrotic syndrome reported rarely. Monitor patients with CHF, liver cirrhosis, nephrotic syndrome, overt renal disease and in long term use. Pregnancy, lactation. Contains galactose. Perform ophthalmic evaluation if visual complaints. C Warfarin, heparin; not recommended. Caution: Oral anticoagulants, anti-hypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporin, NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, other protein-bound drugs. A GI disturbances, oedema, CNS effects, rash and pruritus.
Propionic acid. Naproxen 250mg, 500mg. White film-ctd. tabs. 250mg-100, A5.19; 500mg-100, A10.40. S Rheumatoid arthritis, osteoarthrosis, spondylitis, acute gout. Juvenile rheumatoid arthritis. Dysmenorrhoea. P 250-500mg twice daily. Max. 1g daily. Dysmenorrhoea: 500mg initially then 250mg every 6-8 hours. Q Juvenile rheumatoid arthritis only : Under 5 years, not recommended; 5-12 years, 10mg/kg body weight daily in two divided doses taken twelve hourly. Other indications, children under 16 years: not recommended. D Peptic ulcer disease, active peptic ulcer, intestinal inflammatory disease. Hypersensitivity to naproxen. Aspirin/NSAID induced allergy. B Elderly. History of GI disease. Renal or hepatic impairment. Asthma, allergic disease. Congestive cardiac failure. Platelet aggregation is decreased and bleeding time is prolonged. Pregnancy, lactation. C Anticoagulants, hydantoins, sulphonamides, lithium, b-blockers, methotrexate, probenecid, frusemide. A GI intolerance (nausea, vomiting, epigastic distress), Hypersensitivity/skin reactions (rash, urticaria, anaphylaxis, angio-oedema). Headache, tinnitus, vertigo, blood dyscrasias.
FENOPINE
Amino-monosaccharide. Glucosamine (equiv. to 509mg glucosamine sulphate) 400mg. White, hard cap. GMS: 90, A12.23; non-GMS: 1000, A91.98. S Mild to moderate osteoarthritis of the knee. P 400mg 3 times daily (or 1200mg once daily) with full glass of water. Q Under 18 years, not recommended. D Allergy to shellfish. Pregnancy, lactation.
Pinewood
2MO NSAID. Ibuprofen 200mg, 400mg, 600mg. 200mg, 400mg: Pink, circular, film-ctd tab. marked IBU200 or IBU400. 600mg: Pink, biconvex, coated tab. 200mg-100, A3.45; 500, A17.27; 400mg-100, A5.20; 500, A22.89; 600mg-100, A7.27. S Various arthroses such as rheumatoid arthritis (incl. Stills disease), osteoarthritis, fibrositis, ankylosing spondylitis, and other muscular syndromes such as low back pain, soft tissue trauma and various inflammations of the tendon, joint capsules and ligaments. Mild to moderate pain such as dysmenorrhoea, dental and post-operative pain. P 1200-1600mg daily in divided doses. Max. daily dose: 2400mg. Q Body weight over 30kg, 20mg/kg daily in divided doses; 20-30kg, max. daily dose 400mg; under 20kg, not recommended. D Hypersensitivity to aspirin or other NSAIDs. Active peptic ulceration or history of severe ulceration. B Renal, cardiac, hepatic impairment (monitor renal function). Elderly (prolonged use not recommended). Pregnancy. History or evidence of peptic or intestinal ulceration, asthma, intracranial haemorrhage and bleeding diathesis, atopic patients or patients who have developed bronchospasm with other NSAIDs. C Protein binding drugs incl. anticoagulants (warfarin, heparin), sulphonamides and hydantoins; caution. Enhance effects of Lithium. A GI disturbances. Headache, dizziness, vertigo, hearing disturbances, rash, oedema, blurred vision, hypersensitivity, haematuria or thrombocytopenia.
2MO
MELFEN
Clonmel
2MO
NSAID. Ibuprofen 200mg, 400mg, bright pink sugctd tabs. marked with logo and coded 178 or 179. 200mg-100, A2.79; 400mg-100, A4.51; 250, A11.23; 500, A22.06. S Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and periarticular disorders, fibrositis, cervical B Exclude presence of joint disease spondylitis, low back pain, painful musculorequiring alternative treatments. Diabetes skeletal disorders. (monitor more closely at start of treatment). P 1200_1800mg daily in divided doses. Contains K+ (caution, patients on controlled K+ diet Max. 2400mg daily. or with reduced kidney function). Q 20mg/kg body-wt. daily. Dose should Hypercholesterolaermia (rare). not exceed 500mg daily for children weighing less A GI disorders, headache, tiredness. than 30 kg. D Active peptic ulcer. Continuous use over MEFAC Rowex prolonged periods in the elderly. B Aspirin/anti-inflammatory induced 2MO allergies. Asthma. Pregnancy. Intracranial NSAID. Mefenamic acid 250mg blue/white cap. haemorrhage, bleeding diathesis. marked MEFAC 250. 500mg yellow oval-shaped film-ctd tab. marked MEF 500. 250mg-100, A5.21; C Oral anticoagulants, thiazide diuretics, lithium. Anti-hypertensives diuretics, cardiac 500, A25.42; 500mg-100, A9.23. glycosides, methotrexate, cyclosporin, other S Rheumatic, muscular or arthritic NSAIDs, corticosteroids, aminoglycosides, disorders incl. rheumatoid arthritis, Stillâ&#x20AC;&#x2122;s disease probenecid, oral hypoglycaemic agents. and osteoarthritis. A Dyspepsia, GI bleeding, rash, rarely P 500mg three times daily. thrombocytopenia. Headache, oedema, blurred Q Not recommended. D Ulcerative lesions of GI tract. Pregnancy, vision, hypersensitivity, abnormal liver function and renal impairment. lactation. Renal or hepatic impairment. B Elderly. Bronchial asthma and allergic MOBIC Boehringer Ing. disorders. C Anticoagulants. 2MO A Diarrhoea, skin rash, headache, NSAID. Meloxicam 7.5mg, 15mg; pale yellow bronchospasm, GI disturbance. Renal impairment. scored tabs. marked with company logo and Thrombocytopenia. coded 59D or 77C. 7.5mg-30, A4.21; 15mg-30, A5.89. MELCAM Rowex S Short term treatment of exacerbations Gerard 2 M O of osteoarthritis. Long term treatment of NSAID. Meloxicam 7.5mg, 15mg. Pale yellow rheumatoid arthritis, ankylosing spondylitis.
GERINAP EC 2MO
154
GLUCOSAMINE
RHEUMATOLOGY
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
PAIN
P Osteoarthritis: 7.5mg once daily, increased if necessary to max. 15mg once daily. Rheumatoid arthritis, ankylosing spondylitis: 15mg once daily. tab. should be taken with a meal. R 7.5mg once daily. Q Under 15 years, not recommended.
2MO ALSO MOBIC SUPPOSITORIES Meloxicam 15mg. Suppository. 12, A6.48. S Long term treatment of rheumatoid arthritis, ankylosing spondylitis. P Rheumatoid arthritis, ankylosing spondylitis: 15mg rectally daily. Q Under 15 years, not recommended. D Severe hepatic or renal failure. Severe uncontrolled HF. History of GI bleeding or perforation related to previous NSAIDs; active, or history of recurrent peptic ulcer/haemorrhage. Aspirin/anti-inflammatory induced allergy. Bleeding disorders. Pregnancy, lactation. Proctitis/ history of rectal bleeding (suppos. only) B History of GI lesions, peptic ulcer or GI bleeding. Elderly. Congestive cardiac failure, liver cirrhosis, renal failure. Oedema, hypertension, and cardiac failure have been reported. C Lithium, other NSAIDs (avoid), methotrexate, IUDs, diuretics, ciclosporin, antihypertensives, thrombolytics, antiplatelets, SSRIs, cholestyramine. Anticoagulants, ticlopidine (tabs/supps. only). A Dyspepsia, nausea, stomatitis, oesophagitis, skin rash, headache, vertigo, oedema, palpitations. Disturbances of renal or liver function tests.
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
5.1
antagonists, ACE inhibitors, b-blockers, cyclosporin, glucocorticoids, intrauterine devices, cholestyramine. A Anaemia, light-headedness, headache, GI disorders, pruritus, rash, oedema incl. oedema of the lower limbs.
MOBIGLAN
C Not recommended: Other NSAIDs, lithium, oral anticoagulants. Caution: Thrombolytics and antiplatelet drugs, diuretics, AII receptor antagonists, ACE inhibitors, b-blockers, cyclosporin, intrauterine devices, glucocorticoids, methotrexate, cholestyramine. A Anaemia, lightheadedness, headache, GI Niche disorders, pruritus, rash, oedema.
2MO
NSAID. Meloxicam 7.5mg, 15mg. Light yellow round biconvex bevelledged tab., 7.5mg marked B and 18 on one side; 15mg, scored and marked B and 19 on either side of breakline. 7.5mg-30, A6.23; 15mg-30, A8.77. S Short-term treatment of exacerbations of osteoarthrosis. Long-term treatment of rheumatoid arthritis (RA) or ankylosing spondylitis (AS). P Osteoarthrosis: 7.5mg/day as single dose with water or other liquid during meal; may be increased to 15mg/day. RA/AS: 15mg/day; may be reduced to 7.5mg/day. Max. 15mg/day. Dialysis patients with severe renal failure: 7.5mg/day. R 7.5mg/day Q Under 15 years, not recommended. D Pregnancy, lactation. History of or active GI ulcer, severely impaired liver function, nondialysed severe renal failure, GI/cerebrovascular bleeding or other bleeding disorders, severe uncontrolled HF. B History of oesophagitis, gastritis and/or peptic ulcer, GI symptoms or history of GI disease. Bronchial asthma. Elderly, cardiac failure, cirrhosis, nephrotic syndrome or renal failure, major surgery; monitor diuresis and renal function. May MOBICAM Pinewood mask symptoms of underlying infectious disease. 2MO May impair women fertility. Contains lactose. NSAID. Meloxicam 7.5mg, 15mg. Pale yellow C Not recommended: Other NSAIDs, round tab. scored on one side. 7.5mg-30, A7.01; lithium, oral anticoagulants. Caution: 15mg-30, A9.82. Thrombolytics and antiplatelet drugs, diuretics, AII S Short-term symptomatic treatment of receptor antagonists, ACE inhibitors, b-blockers, exacerbations of osteoarthrosis. Long-term cyclosporin, intrauterine devices, methotrexate, symptomatic treatment of rheumatoid arthritis cholestyramine. (RA) or ankylosing spondylitis (AS). A Anaemia, lightheadedness, headache, GI P Osteoarthrosis: 7.5 mg/day. May be disorders, pruritus, rash, oedema. increased to 15 mg/day. RA and AS: 15mg/day. Increased risks for adverse reactions, 7.5mg/day MOVOX Teva initially . Dialysis patients with severe renal failure, 2 M O max 7.5mg/day. R Osteoarthritis: As per adults. RA and AS: NSAID Meloxicam 7.5mg, 15mg. Pale yellow round tabs. with score line on one side. 7.5mg-30, A6.31; 7.5mg/day. 15mg-30, A8.84. Q Under 15 years, not recommended. S Short-term treatment of exacerbations D Hypersensitivity to NSAIDs and aspirin. of osteoarthrosis. Long-term treatment of Active GI ulcer or history of recurrent GI ulcer. rheumatoid arthritis or ankylosing spondylitis. Severely impaired liver function. Non-dialysed P Exacerbations of osteoarthrosis: 7.5mg/ severe renal failure. GI bleeding, cerebrovascular day as a single dose with water or other liquid bleeding or other bleeding disorders. Severe HF. during meal; may be increased to 15mg/day. Severe CHF. Pregnancy, lactation. B Uncontrolled hypertension, CHF, history Rheumatoid arthritis, ankylosing spondylitis: 15mg/ day; may be reduced to 7.5mg/day. Max. 15mg/ of oesophagitis, gastritis and/or peptic ulcer, GI day. Dialysis patients with severe renal failure: symptoms or history of GI disease, bronchial asthma. Monitor diuresis and renal function. May 7.5mg/day. R 7.5mg/day. occur: GI bleeding (withdraw), severe skin Q Under 15 years, not recommended. reactions (discontinue), interstitial nephritis, D Pregnancy, lactation. History of or active glomerulonephritis, renal medullary necrosis or GI ulcer, severely impaired liver function, nonnephrotic symptoms, Na+ and water retention, hyperkalaemia, transient increases in liver function dialysed severe renal failure, GI/cerebrovascular bleeding or other bleeding disorders, severe parameters, serum creatine and blood urea uncontrolled HF. nitrogen. May mask symptoms of underlying B History of oesophagitis, gastritis and/or infectious disease. May impair fertility of women. peptic ulcer, GI symptoms or history of GI disease. Contains lactose. Bronchial asthma. Congestive cardiac failure, C Not recommended: Other NSAIDs, cirrhosis, nephrotic syndrome or renal failure, lithium, oral anticoagulants, high dose major surgery; monitor diuresis and renal function. methotrexate, Caution: Thrombolytics and antiplatelet drugs, diuretics, aII receptor Elderly. Contains lactose.
NAPROSYN EC
Roche
2MO Propionic acid. Naproxen 250mg, 500mg. White ent-ctd tab. marked NAPROSYN EC one side, SYNTEX 250 on reverse and oblong white ent-ctd tab. marked NAPROSYN EC and SYNTEX. 250mg56, A3.12; 500mg-56, A6.25. S Rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute gout. P 500mg-1g daily in two divided doses 12 hourly or as a single dose morning or evening. 1g daily should not be used for longer than 6 months. Q Juvenile rheumatoid arthritis only: Under 5 years, not recommended; 5-16 years, 10mg/kg body weight daily in two divided doses. D Active peptic ulcer or GI inflammation. Aspirin/anti-inflammatory induced allergy. B Elderly. History of GI lesions. Renal or hepatic impairment. Asthma. Pregnancy, lactation. C Anticoagulants, hydantoins, sulphonylureas, lithium, b-blockers, methotrexate, probenecid, frusemide. A Rash, GI intolerance, headache, tinnitus, vertigo, blood dyscrasias.
NU-SEALS 300
Alliance
2MO Salicylate. Aspirin 300mg. White ent-ctd tab. marked 300 in red. 100, A4.76. S Rheumatism, rheumatoid arthritis. P 300-900mg 3 or 4 times daily. Max. 8g daily. Q Under 16 years, not recommended. D Hypoprothrombinaemia, haemophilia, cerebral haemorrhage, active peptic ulceration, lactation. B Not for short-term pain relief. Renal, cardiac or hepatic impairment. May induce GI haemorrhage. Long-term use, elderly; review regularly. Caution: History of IBD, coagulation abnormalities. Hypertension, monitor. Pregnancy (avoid at term). C AAvoid: Warfarin, heparin, other NSAIDs, antacids (simultaneous use). Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporine, tacrolimus, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, anticoagulants, antiplatelets, fibrinolytics, carbonic anhydrase inhibitors, ibuprofen. A Asthma, urate kidney stones, chronic GI blood loss, tinnitus, nausea, vomiting.
ORUVAIL
sanofi-aventis
2MO Propionic acid. Ketoprofen 200mg. White/pink controlled-release caps. marked with Oruvail 200. 28, A19.61. S Rheumatoid arthritis, osteoarthrosis, ankylosing spondylitis, acute articular and periarticular disorders, non-infectious arthropathy, sciatica, painful musculoskeletal conditions. Dysmenorrhoea. P 100-200mg once daily with food.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
155
5.1 PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
Q Not recommended. D Hypersensitivity to NSAIDs. Severe renal or hepatic dysfunction. Active or history of peptic ulcer haemorrage or GI bleeding/perforation related to NSAID therapy. Severe heart failure. 3rd trimester of pregnancy. B Hypertension. Heart failure. Arterial thrombotic events. Cardiovascular disease. Oedema. GI toxicity. Visual disturbances. Impairment of female fertility. Serious skin reactions. Patients with intracranial haemorrhage and bleeding diathesis. Asthma. Elderly. Driving/ operating machinery. C Not recommended: Anticoagulants, antiplatelet agents, other NSAIDs, SSRIs, lithium, methotrexate. Diuretics, pentoxifylline, corticosteroids, b-blockers, ACE inhibitors and angiotensin II antagonists, amino and cardiac glycosides, cyclosporin, probenecid, thrombolytics, sulphonylureas. A GI intolerance, hypersensitivity reactions, haematology disorders, headache, weight gain, taste perversion, tinnitus, dizziness, paresthesia, convulsions, somnolence, mood disorders, oedema.
arthritic pain. Primary dysmenorrhoea. Dysfunctional menorrhagia. P 500mg three times daily. Q Not recommended. D Ulcerative lesions or inflammation of GI tract. Renal or hepatic impairment. Pregnancy, lactation. Aspirin/NSAID induced bronchospasm, rhinitis or urticaria. B Elderly. Renal dysfunction. Regular surveillence if therapy is prolonged. Discontinue if liver dysfunction, rash, blood dyscrasias or diarrhoea occur. Cardiac or hepatic impairment. History of peptic ulcer or inflamatory bowel disease. Intracranial haemorrhage or bleeding diathesis. C Anticoagulants, other plasma protein bound drugs. Antihypertensives, diuretics, cardiacglycosides, lithium, methotrexate, cyclosporin, other NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycaemics. A GI disturbance, diarhoea, headache, bronchospasm, rash, renal dysfunction, thrombocytopenia and other blood dyscrasias.
RELIFEX
Galen Alkanone. Nabumetone 500mg. Red film-ctd tab.
2MO
marked RELIFEX 500. 56,
Amino-monosaccharide. Glucosamine HCI (equiv. to 625mg glucosamine) 750mg. Yellow, oblong, film-ctd tab. printed with A. 60, A25.46. S Mild to moderate osteoarthritis. P Initially 1 tab. twice daily. Clinical effect usually seen within 4 weeks. Once symptoms have been relieved, dose may be reduced to 1 tablet daily. Q Under 18 years, not recommended. D Allergy to shellfish. B Exclude presence of joint disease. Diabetes mellitus (monitor more closely at start of treatment). Pregnancy, lactation; not recommended. A Headache, drowsiness, dyspepsia, skin rash, pruritus, erythema.
itraconazole, erythromycin, rifampicin, carbamazepine, barbiturates, Ca++ antagonists, HMG-CoA reductase inhibitors, colchicine, nephrotoxic drugs, oral contraceptives, propafenone, prednisolone, methylprednisolone, K+suppl., K+sparing diuretics, lipid solutions, NSAIDs. A Renal and hepatic dysfunction, tremor, GI disturbances, hypertrichosis, gingival hypertrophy, burning sensations (feet and hands), fatigue, muscle weakness or cramp, myopathy, malignancies, lymphoproliferative disorders. Rarely hyperkalaemia, hyperuricaemia, hypomagnesaemia, oedema, convulsions, headache, rash, mild anaemia, haemolytic uraemic syndrome, weight gain, pancreatitis, colitis, paraesthesia, neuropathy, confusion, dysmenorrhoea, amenorrhoea, gynaecomastia, encephalopathy.
VOLTAROL
Novartis
2MO NSAID. Diclofenac Na+ 25mg, 50mg. Yellow entctd tab. and brown ent-ctd tab. Both marked with
Meda tab. name and strength one side, GEIGY on
2MO
OSTEOEZE
RHEUMATOLOGY
A18.62.
2MO
ALSO RELIFEX SUSPENSION Nabumetone 500mg/ 5ml. 300ml, A21.93. S Osteoarthritis and rheumatoid arthritis, spondylitis, gout and musculoskeletal disorders such as sports injuries. P 2 tabs. or 10ml as a single bedtime dose. In more severe cases an additional 1-2 tabs. or 5-10ml may be given in the morning. Max. 2g daily. R Max. 1g daily. Q Not recommended. D Active peptic ulceration. Pregnancy (unless essential), lactation. B History of peptic ulceration. Aspirin hypersensitivity. CHF. Renal, cardiac or hepatic impairment; monitor renal function. OSTEOLE Pinewood C Caution: Oral anticoagulants, antihypertensives, diuretics, cardiac glycosides, 2MO lithium, methotrexate, ciclosporin, other NSAIDs, Amino-monosaccharide. Glucosamine sulfate corticosteroids, aminoglycosides, progenicid, oral 1500mg. White to slightly yellow crystalline hypoglycemics, sulphonamines, hydantoins. A odourless powder for oral solution. 30, 20.28. S Symptoms of osteoarthritis (i.e. pain and A GI disorders incl. gastric ulcer and GI bleeding, headache, dizziness, confusion, sedation, function limitation). P 1 sachet once daily, preferably at meals. hypersensitivity, anaphylaxis, angioedema. Safety and efficacy confirmed for treatment of up SANDIMMUN Novartis to 3 years. Q Safety and efficacy not established. 2MT D Phenylketonuria. Fungal metabolite immunosuppressant. B Renal or hepatic insufficiency: Admin Cyclosporin 25mg pale pink oval cap., 50mg under medical supervision. Caution: Shellfish yellow oblong cap.; 100mg dusky pink oblong cap. allergy. Contains sodium. 25mg-30, A29.01; 50mg-30, A53.77; 100mg-30, C Warfarin. A105.50. A GI disturbances. 2NT
reverse. 25mg-84, A5.18, 25mg-100, A3.31; 50mg50, A3.89. S Musculo-skeletal disorders, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout. Chronic juvenile arthritis. Dysmenorrhoea. P 75-150mg daily in 2 or 3 divided doses taken with liquid. Q 1-3mg/kg body weight daily in divided doses.
2MO ALSO VOLTAROL RETARD Diclofenac Na+ 75mg, 100mg. Pink triangular sust.-release tab. marked CG one side, ID on reverse and red sust.-release tab. marked VOLTAROL R one side, GEIGY on reverse. 75mg-30, A5.42; 100mg-28, A14.46; 100mg-30, A7.43. P 1 x 75mg once daily or 1 x 75mg twice daily, alternatively 1 x 100mg once daily. Both strengths taken whole at mealtime. Q Use paed. suppos.
2MO ALSO VOLTAROL SUPPS Diclofenac Na+ 100mg. 10, A1.39. P 1 at night. Q Use paed. suppos.
2MO ALSO VOLTAROL PAED. SUPPS Diclofenac Na+ 12.5mg. 10, 68c. Q 1-3mg/kg body weight daily in divided doses.
2NO
ALSO VOLTAROL INJECTION Diclofenac Na+ 75mg/3ml. Amp. 10 x 3ml, A3.37. S Acute back pain and trauma, postoperative pain, renal colic. P 75mg IM once or in severe cases twice ALSO SANDIMMUN ORAL SOLUTION Cyclosporin daily by deep intra-gluteal inj. for max. of 2 days. PONALGIC Antigen 100mg/ml; oral soln. 50ml, A163.91. Q Not applicable. 2MO D Active or suspected peptic ulcer. S Severe active rheumatoid arthritis NSAID. Mefenamic acid 250mg. Yellow/blue cap. Asthma, aspirin/anti-inflammatory induced allergy. refractory to other agents. marked ANTIGEN and coded MA250. 100, A4.67; B Renal, cardiac or hepatic impairment. V See lit. 500, A23.81. Elderly. Pregnancy, lactation. Recent proctitis. D Impaired renal function, uncontrolled 2MO hypertension, uncontrolled infection. Malignancy. C Lithium, digoxin, anticoagulants, ALSO PONALGIC FORTE TABLETS Mefenamic acid B Monitor renal and liver function, BP and antidiabetic agents, cyclosporin, methotrexate, 500mg. Yellow film-ctd tab. marked with logo and serum lipids. Hyperkalaemia, hyperuricaemia. quinolone antimicrobials, other NSAIDs, coded MA500. 100, A9.31. corticosteroids, diuretics. Pregnancy, lactation. A Epigastric pain, nausea, headache, C Systemic antibiotics, live vaccines, S Mild to moderate pain incl. headache, dizziness, rash, elevation of liver enzymes. phenytoin, ketoconazole, fluconazole, dental or post-op pain, rheumatic, muscular or
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
SEVERE
ACTIVE RHEUMATOID ARTHRITIS
range. Use antihistamines, steroid cover, or temporary reduction of dose to control urticarial reactions. Reversible loss of taste may occur. Stop treatment immediately if haematuria occurs in the ARAVA sanofi-aventis absence of renal stones or other known cause. A 2NO late rash may occur after several months or years DMARD. Leflunomide 10mg, 20mg, 100mg. Resp. of therapy (dose may need to be reduced). Breast white and round, yellow triangular or white and enlargement may occur in men and women. round film-ctd tab. marked ZBN, ZBO or ZBP. DMARDs linked with septic arthritis in RA patients. 10mg-30, A63.47; 20mg-30, A63.47;100mg-3, C Gold salts, anti-inflammatory, oral iron, A31.73. drugs known to cause bone marrow or renal S Active rheumatoid arthritis. Active injury. psoriatic arthritis. A Thrombocytopenia, proteinuria. P Loading dose: 100mg once daily for 3 days. RA: Maintenance, 10-20mg once daily. ENBREL Wyeth Psoriatic arthritis: Maintenance, 20mg once daily. 2MT Q Under 18 years, not recommended. Tumour necrosis factor (TNF) antagonist. D Impaired liver function. Severe Etanercept 25mg, 50mg. 25mg: Vials containing immunodeficiency. Significantly impaired bone powder and solvent for soln. for inj. or pre-filled marrow function or significant blood dyscrasias syringe. 50mg: prefilled syringe. Prices available on due to causes other than rheumatoid or psoriatic request. arthritis. Serious infections. Moderate to severe S Adult rheumatoid arthritis (RA): When renal insufficiency. Severe hypoproteinaemia, (e.g. response to other agents incl. methotrexate (MTX) nephrotic syndrome). Pregnancy; contraception has been inadequate or patients not previously must be used until plasma levels fall below treated with MTX, in combination with MTX or as 0.02mg/l. Lactation. monotherapy where necessary. Polyarticular-course B Use under specialist supervision. juvenile idiopathic arthritis in children (4-17 years) Monitor AST, ALT, BP before and regularly during where MTX is ineffective or contraindicated. Adult therapy. Take complete differential blood counts psoriatic arthritis, adult severe active ankylosing every 2 weeks for first 6 months, then every 8 spondylitis; when response to other agents has weeks. A washout procedure must be done if been inadequate. toxicity develops when switching to another P 25mg SC twice weekly or 50mg SC once DMARD or for a desired pregnancy; See SPC. weekly. Advise patient to report signs of infection. Q 4-18 years: 0.4mg/kg SC twice weekly (3Monitor patients with tuberculin reactivity. 4 day interval between doses). Interstitial lung disease may occur. Contains D Sepsis or risk of sepsis. Active infections lactose. incl. chronic or localised infections. Treatment of C Not recommended: Cholestyramine, Wegener’s granulomatosis. Pregnancy, lactation. activated charcoal, live vaccines, other DMARDs B Evaluate for infections before, during, (methotrexate). Caution: Hepatotoxic or and after treatment. Monitor new infections haematoxic drugs, drugs metabolised by CYP2C9 (discontinue if serious). History of recurring or (not NSAIDs), rifampicin. chronic infections or predisposing conditions (incl. A Leucopenia, mild allergic reactions, advanced or poorly controlled diabetes). Serious increased CPK, paraesthesia, headache, dizziness, infections, sepsis, tuberculosis, and other mild BP increase, GI disorders, elevation of liver parameters, increased hair loss, eczema, rash (incl. opportunistic infections, have been reported. Evaluate for tuberculosis before treatment. Do not maculopapular), pruritus, dry skin, tenosynovitis, initiate in active tuberculosis. Treat latent anorexia, weight loss, asthenia. tuberculosis before initiation. May reactivate DISTAMINE Alliance hepatitis B virus in chronic carriers (monitor). May worsen hepatitis C. CHF, history of blood 2MO dyscrasias. Existing or risk of CNS demyelinating Penicillin deriv. Penicillamine base 125mg, 250mg. disease. Risk of lymphoma development cannot be White film-ctd tab. marked DS and 125 or DM and excluded (reported rarely). Non-melanoma skin 250. 125mg-100, A12.44; 250mg-100, A21.45. cancer (NMSC) reported in patients treated with S Severe active rheumatoid arthritis incl. TNF-antagonists; periodic skin examination juvenile forms. P Initially 125-250mg daily for four weeks recommended for all patients at increased risk for increasing by same amount at 4-12 week intervals NMSC (incl. patients with psoriasis or history of PUVA therapy). Caution: Moderate to severe until remission. Usual maintenance, 500-750mg alcoholic hepatitis; do not use to treat alcoholic daily. Max. 1.5g daily. hepatitis. R Initially 125mg (max) daily increasing to C Anakinra, abatacept or live vaccines maintenance, max. 1g daily. (not recommended). Sulfasalazine. Q Under 8 years, not recommended; 8 A Inj. site reactions. Infections (e.g. upper years and over, 2.5-5mg/kg body weight daily for RTIs, bronchitis, cystitis, skin infections). Pruritus, one month increasing at four weekly interval; fever, allergic reactions, autoantibody formation. maintenance 15-20mg/kg daily.
5.2 SEVERE ACTIVE RHEUMATOID ARTHRITIS
D Agranulocytosis or severe thrombocytopenia due to penicillamine. Lupus erythematosus. Lactation. Persistent proteinuria. Moderate/ severe renal impairment. Pregnancy. B Renal insufficiency. Monitor blood, urine and renal function before and frequently during treatment. Consider withdrawal if platelets fall Q 120,000 or white blood cells Q 2,500/mm3, or if 3 successive falls noted within the normal
HUMIRA
Abbott
2NT Tumour necrosis factor (TNF) antagonist. Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled pen or pre-filled syringe (2 per pack). Price available on request. S Moderate to severe, active rheumatoid arthritis (RA) where response to anti-rheumatics
5.2
incl. methotrexate (MTX) was inadequate. Severe, active and progressive RA in adults not previously treated with MTX. Active and progressive psoriatic arthritis where response to anti-rheumatics was inadequate. Severe active ankylosing spondylitis where response to conventional therapy was inadequate. P 40mg once fortnightly by SC inj. Clinical response usually achieved within 12 weeks; if not, reconsider therapy. RA: Continue MTX during treatment. Q Under 18 years, not recommended. D Active tuberculosis, other severe infections (sepsis), uncontrolled / opportunistic infections. Moderate to severe HF. Pregnancy, lactation. B Monitor for infections, incl. tuberculosis, before, during and after treatment; discontinue if serious. Do not initiate if active, chronic or localised infection unless controlled. Pre-existing or recent-onset CNS demyelinating disorders, mild HF (caution), COPD, heavy smokers. Use adequate contraception, avoid breastfeeding and pregnancy for 5 months after last treatment. Malignancies incl. lymphoma, demyelinating disease, HBV reactivation, pancytopenia reported. C Increased antibody formation and Humira clearance when admin. without methotrexate. Live vaccines, anakinra (not recommended), immunosupressants (caution). A Inj. site reaction, upper and lower respiratory infections, viral/bacterial infections, candidiasis, dizziness, headache, neurological sensation disorders. Cough, nasopharyngeal pain, diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, pruritus, dermatitis, eczema, hair loss, musculoskeletal pain, pyrexia, fatigue.
KINERET
Biovitrum
2NT Interleukin-1 receptor antagonist. Anakinra 100mg/0.67ml (150mg/ml). Soln. for inj. in prefilled syringe. 28 pre-filled syringes, A1032.11. S Treatment of signs and symptoms of rheumatoid arthritis (RA) in combination with methotrexate in patients with inadequate response to methotrexate alone. P 100mg once daily by SC inj. R As for adults. Q Not recommended. D Pregnancy, lactation. Renal impairment. Hypersensitivity to E. coli derived proteins. B Serious/chronic infections, neutropenia (ANC Q1.5x109/L, discontinue), immunosuppression, malignancy. Elderly. Live vaccines. Ensure adequate contraception. Needle cover contains dry natural rubber. A Inj. site reactions, headache, neutropenia, serious infections (requiring hospitalisation).
MABTHERA
Roche
2N Monoclonal antibody. Rituximab 10mg/ml. Soln. in vial. 2x10ml, A653.14; 1x50ml, A1632.79. S In combination with methotrexate in adults with severe active rheumatoid arthritis where other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor therapies are inappropriate. P 1 course: 1000mg by IV inf. followed by 2nd 1000mg IV inf. two weeks later. 1st inf. rate:
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
157
5.2 SEVERE
RHEUMATOLOGY
ACTIVE RHEUMATOID ARTHRITIS
P Patients Q 60kg: 500mg (2 vials); patients r 60kg to R 100kg: 750mg (3 vials); patients q100kg: 1,000mg (4 vials). Admin. as a 30-minute IV inf. Following initial inf, admin. at 2 and 4 weeks, then every 4 weeks thereafter. If no response within 6 months, consider the potential benefits of continuing treatment. Q Not recommended. D Severe and uncontrolled infections such as sepsis and opportunistic infections. Pregnancy (unless clearly necessary), lactation. Women should use contraception and not breast feed during NEORAL Novartis treatment and up to 14 weeks after last dose. B History of recurrent infections or 2MT underlying conditions predisposing to infections. Fungal metabolite immunosuppressant. Monitor patients who develop a new infection Cyclosporin 25mg blue-grey oval cap., 50mg during treatment; discontinue if serious. Screen for yellow-white oblong cap.; 100mg blue-grey latent tuberculosis and viral hepatitis before oblong cap. All marked with S in a triangle and cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; initiating. Potential role in the development of METHOTREXATE Goldshield 100mg-30, A96.03; malignancies is unknown. Do not admin. live vaccines during treatment or within 3 months of 2NO 2MT discontinuation. Use in elderly. Theoretically use Folic acid antagonist. Methotrexate 2.5mg. Yellow ALSO NEORAL ORAL SOLUTION Cyclosporin might increase the risk for autoimmune processes. tab. marked 2.5 one side, scored and marked MI 100mg/ml. Oral soln. 50ml, A143.89. Allergic reactions may occur. Contains maltose A on reverse. 28, 3.49. S Severe active rheumatoid arthritis (may interfere with the readings of blood glucose S Acute leukaemia, carcinoma. Severe, refractory to other agents. monitors). Contains 8.625mg Na+/vial. active rheumatoid arthritis, psoriasis unresponsive P Initially 3mg/kg daily in two divided C Not recommended: TNF blocking agents to other therapy. doses for 6 weeks. Increase gradually over next 6 P Varies according to malignant condition. weeks according to response; max. 5mg/kg daily in and leflunomide. A BP increased, abnormal liver function RA: 7.5mg once weekly or 2.5mg at 12 hourly two divided doses. tests, headache, dizziness, cough, abdominal pain, intervals for 3 doses as a course once weekly. Max Q Not recommended. diarrhoea, nausea, dyspepsia, rash, lower and 20mg weekly. Psoriasis: 10-25mg orally once a D Impaired renal function, uncontrolled week. hypertension, uncontrolled infection. Malignancy. upper RTIs, UTIs, herpes simplex, rhinitis, hypertension, flushing, fatigue, asthenia. B Only use under specialist supervision. METOJECT Fannin Closely monitor renal and liver function, BP and PLAQUENIL Sanofi serum lipids, serum K+. Hyperkalaemia, 2NO 2MO hyperuricaemia. Pregnancy, lactation. Active Folic acid antagonist. Methotrexate (as methotrexate disodium) 10mg/ml. Sln for inj., pre- herpes simplex infections should be cleared before Aminoquinoline. Hydroxychloroquine sulph. 200mg white film-ctd tab. marked HCQ one side filled syringe. 10mg/1ml-1, A16.97; 10mg/1.5ml-1, treatment. Not bioequivalent to Sandimmun; and 200 on reverse. 60, A24.37. specify brand when prescribing. A21.02; 10mg/2ml-1, A22.83; 10mg/2.5ml-1, C Systemic antibiotics, live vaccines, S Rheumatoid arthritis, juvenile A23.36. phenytoin, ketoconazole, fluconazole, rheumatoid arthritis, lupus erythematosus. S Severe, active rheumatoid arthritis. P Initially 400mg daily in divided doses P Initially 7.5mg once weekly by SC, IM or itraconazole, erythromycin, rifampicin, ++ carbamazepine, barbiturates, Ca antagonists, reducing to 200mg when no improvement is IV. May increase by 2.5mg/week up to 25mg/week HMG-CoA reductase inhibitors, colchicine, evident. Discontinue treatment after six months if (max.). Expect response after 4-8 weeks. no improvement occurs. Maintenance: Reduce gradually to lowest effective nephrotoxic drugs, oral contraceptives, prednisolone, methylprednisolone, Q See literature. dose. Renal impairment: cc: 20-50ml/min: 1/2 dose. propafenone, + + suppl., K sparing diuretics, lipid solutions, K D Maculopathy. R Consider dose reduction. NSAIDs, doxycycline, sulphadiazine, IV B Porphyria. Renal or hepatic impairment. D Severe liver/renal insufficiency, alcohol sulphadimidine, IV trimethoprim, diclofenac, History of GI, neurological or blood disorders. abuse, pre-existing blood dycrasias, severe acute/ nifedipine, grapefruit juice. Psoriasis. Perform regular eye tests before and chronic infections, oral cavity ulcers and known A Renal and hepatic dysfunction, during long-term therapy. Pregnancy, lactation. active GI ulcer disease, pregnancy, lactation, hypertension, tremor, GI disturbances, C Drugs causing ocular damage, antacids, concurrent vaccination with live vaccines, hypertrichosis, gingival hypertrophy, malignancies, aminoglycosides. immunodeficiency syndromes. A Retinal changes, corneal opacity. B Use under specialist supervision. Before lymphoproliferative disorders, burning sensations (feet and hands), fatigue, muscle weakness or Impaired visual accommodation (discontinue if use perform complete blood count, liver/renal cramp, myopathy. Rarely hyperkalaemia, occur). Skin reactions, bleaching of the hair, function tests, chest x-ray. Exclude tuberculosis hyperuricaemia, hypomagnesaemia, alopecia, GI intolerance. and hepatitis. Dosesq20mg/week (risk of hypercholesterolaemia, oedema, convulsions, increased toxicity). During, regularly monitor: REMICADE Schering-Plough headache, rash, mild anaemia, haemolytic uraemic Mouth/throat for mucosal changes, blood count, syndrome, weight gain, pancreatitis, colitis, 2N liver/renal function, respiratory system (risk of paraesthesia, neuropathy, confusion, Monoclonal antibody. Infliximab 100mg. Powder interstitial pneumonitis often with eosinophilia, dysmenorrhoea, amenorrhoea, gynaecomastia, for conc. for soln in vial. 1, A690.43. fatalities reported). Discontinue/decrease dose encephalopathy. S Rheumatoid arthritis in combination where necessary. If methotrexate induced lung with methotrexate. Psoriatic arthritis (PA) in disease suspected, treat with corticosteroids and ORENCIA BMS combination with methotrexate or alone if discontinue. Caution: Inactive, chronic infections. 2 N contraindicated/ intolerant. Severe active Risk of malignant lymphomas, discontinue if ankylosing spondylitis where conventional therapy occurs. Drain pleural effusions and ascites prior to Immunosuppressant. Abatacept 250mg. Powder for concentrate for soln for inf. 1, A439.43. failed. use. If diarrhoea and ulcerative stomatitis occur P RA: 3mg/kg, IV inf. over 2 hrs followed S Moderate to severe active rheumatoid interrupt therapy. by additional 3mg/kg inf. at 2 and 6 weeks after arthritis in combination with methotrexate in C Alcohol, other hepatotoxics, retinoids, first inf., then every 8 weeks. Ankylosing adult patients who have had an insufficient oral antibiotics (e.g. tetracyclines, spondylitis, PA: 5mg/kg IV over 2 hrs followed by response or intolerance to other DMARDs chloramphenicol), antibiotics (e.g. penicillines, additional 5mg/kg inf. at 2 and 6 weeks after first including at least one tumour necrosis factor glycopeptides, sulfonamides, ciprofloxacin, inf. Then every 6-8 weeks for Ankylosing cefalotin), other protein bound drugs, probenecid, inhibitor. 50mg/hr for 30 min increasing in 50mg/hr increments every 30 min to max. 400mg/hr. 2nd inf: 100mg/hr for 30 min increasing in 100mg/hr increments at 30 min intervals to max. 400mg/hr. Consider repeat course after benefit/risk evaluation and with at least 16-week interval. Q Not recommended. D Lactation, pregnancy (unless benefit outweighs risk). Active, severe infections, severe HF or severe, uncontrolled cardiac disease. B Inf. reactions (consider premedication with IV glucocorticoid). C Avoid live vaccines. Complete vaccines at least 4 weeks before. A Inf. reactions (eg. hypertension, fever, rash) including anaphylactic, infections (eg. RTI, UTI), muscle spasms, osteoarthritis, migraine, paraesthesia, asthenia, GI disorders.
158
weak organic acids, NSAIDs, sulphasalazine, PPIs. Medicines that cause: Bone marrow depression; folate deficiency. Products containing folic/folinic acid. Avoid: Excessive caffeine/theophylline containing beverages. A GI disorders, exanthema, erythema, pruritus, inj. site reactions, headache, tiredness, drowsiness, pneumonia, interstitial alveolitis/ pneumonitis often with eosinophilia, leukopenia, anaemia, thrombocytopenia. Elevated transaminases.
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ri Coming F day March 5 th @
09 :0 1a m
e-Newsletter to
su gistered bscribers. e r 0 ,40 2 er ov
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Monthly Index of Medical Specialities Ireland
a rs
MIMS Ireland
Anniv e
5.3 PROPHYLAXIS
spondylitis; every 8 weeks for PA (if no response by 6 weeks, discontinue). Q Under 17 years, not recommended. D TB (must be screened for active/ inactive), severe infections eg. sepsis, abscesses. Moderate/severe HF. Women should use adequate contraception and should not breastfeed during treatment and within 6 months of last dose. B Monitor for acute inf. reactions during/ within a few hours of inf. If necessary interrupt immediately. Ensure emergency equip. and treatment available. Monitor patients retreated after a long period. Caution: Chronic infection or recurrent infections. Discontinue if patient develops symptoms of lupus-like syndrome, antinuclear antibodies or serious infection. Elderly, hepatic impairment, mild heart failure. Increased risk of malignancies (caution with heavy smokers, history of malignancy). UC patients: Regularly screen for dysplasia. Crohnâ&#x20AC;&#x2122;s: Rare cases of hepatosplenic T-cell lymphoma reported. Paediatric Crohnâ&#x20AC;&#x2122;s: If possible, bring up to date with all vaccinations before initiating Remicade therapy. C Anakinra, live vaccines (not recommended). A Viral infection, serum sickness-like reactions, headache, vertigo, flushing, RTIs, dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC tissue disorders, fatigue, chest pain, fever, elevated hepatic transaminases, inf. reactions.
ROACTEMRA
Roche
;J Interleukin inhibitor. Tocilizumab 20mg/ml. Concentrate for soln for inf. in vial. 80mg/4ml, A167.53; 200mg/10ml, A418.82; 400mg/20ml, A837.65. S Moderate to severe active rheumatoid arthritis (RA) where DMARDs or TNF antagonists ineffective or inappropriate, in combination with MTX or as monotherapy if MTX inappropriate. P 8mg/kg body weight, but no lower than 480mg, as IV infusion over an hour given once every four weeks. Doses above 1.2g have not been evaluated. Adjustment due to abnormalities in liver enzymes, neutrophil or platelet counts, see SPC. Q Under 18 years, not recommended. D Active, severe infections. Pregnancy (unless clearly necessary), lactation. Use contraception up to 6 months after treatment. B Moderate to severe renal impairment, monitor renal function. History of infections or predisposing conditions (e.g. diverticulitis, diabetes), history of intestinal ulceration or diverticulitis. Screen for TB prior to therapy. Active hepatic disease or hepatic impairment, ALT or AST q 1.5 x ULN (not recommended if q5; interrupt if q3-5). Monitor ALT and AST levels every 4-8 weeks for 1st 6 months and every 12 weeks thereafter. Monitor neutrophils, platelets, lipid parameters every 4-8 weeks. Increased risk of malignancy, central demyelinating disorders. Contains Na+. C Live and live attenuated vaccines, other biological agents (not recommended). Caution: CYP450 3A4, 1A2, 2C9 or 2C19. A Upper RTIs, cellulitis, pneumonia, oral herpes simplex, herpes zoster, mouth ulceration, gastritis, headache, dizziness, increased hepatic transaminases/ bilirubin, hypertension, leucopoenia, neutropenia, hypercholesterolaemia.
SALAZOPYRIN 160
RHEUMATOLOGY
AND TREATMENT OF GOUT
Pharmacia
by diet with serum uric r535mcmol/l (9mg/100ml), clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy, dissolution and prevention of uric acid stones, prevention of calcium oxalate stones in concurrent 2MO ALSO SALAZOPYRIN SUSPENSION Sulphasalazine hyperuricaemia. Adults and children: Secondary 250mg/5ml. Orange-lemon flavoured susp. 500ml, hyperuricaemia of differing origin. Adolescents and children: Uric acid nephropathy during A18.50. S Rheumatoid arthritis not responding to treatment of leukaemia, hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome, NSAIDs. adenine phosphoribosyl transferase deficiency. 2MO P Initially, low dosage eg. 100 mg/day ALSO SALAZOPYRIN EN-TABS Sulphasalazine with plenty of liquid after meal. Mild conditions, 500mg. Orange/yellow ent-ctd oval tab. marked 100mg-200mg; moderately severe, 300mg-600mg; KPh one side and 102 on reverse. 112, A13.27. severe, 700mg-900mg daily. Or use 2-10mg/kg/day. P Initially 1 tab. or 10ml daily for one week, increasing by 1 or 10ml each week to max. Admin. dosage q 300mg in divided doses not exceeding 300mg at any time. Impaired renal or 6 or 60ml daily in divided doses. hepatic function: 300mg dose not suitable. Q Not recommended. Haemodialysis, 300mg-400mg immediately after D Jaundice, porphyria. Pregnancy (unless every treatment session. essential). Q 15kg and over, 10mg/kg daily (max. B Hepatic/renal dysfunction, blood 400mg daily) given in 3 divided doses. Must use dyscrasias; great caution. Regular blood checks Alopur 100mg in children Q45kg. Under 15kg, and liver function tests during first 3 months. contraindicated. G6PD deficiency (risk of haemolytic anaemia). D Lactation, pregnancy (unless explicitly Lactation. necessary). Alopur 300mg: Severe renal C Folic-acid antagonists, hypoglycaemics. dysfunction (ccQ20ml/min). A Nausea, headache, rash, fever, loss of appetite. Blood dyscrasias, reversible oligospermia. B Hypersensitivity reactions, discontinue immediately. Monitor closely if impaired renal/ 5.3 PROPHYLAXIS AND TREATMENT OF hepatic function or haematopoiesis disorders. Do not start until acute attack of gout completely GOUT subsided. Elderly. ADENURIC A. Menarini C Avoid ampicillin or amoxicillin. Caution: ACE inhibitors, diuretics, mercaptopurine, 2NO azathioprine, vidarabine, probenecid, salicylate, Uric acid production inhibitor. Febuxostat 80mg, chlorpropamide, anticoagulants, phenytoin, 120mg. Yellow, film-ctd, cap-shaped tabs, marked theophylline, ciclosporin, didanosine, captopril. 80 or 120, resp. 80mg-28, A25.79; 120mg-28, A Skin reactions. A25.79. S Chronic hyperuricaemia in conditions ARCOXIA MSD where urate deposition has already occurred 2MO (including a history, or presence of, tophus and/or COX-2 inhibitor. Etoricoxib 30mg blue-green, gouty arthritis). 60mg dark green; 90mg white; 120mg pale green P 80mg once daily. If serum uric acid q tabs. All apple-shaped film-ctd tab. marked ACX 6mg/dl (357mcmol/l) after 2-4 weeks, consider 30, ARCOXIA 60, ARCOXIA 90 and ARCOXIA 120 120mg once daily. Target: Maintain below 6mg/dl. resp. one side and coded 101, 200, 202 and 204 Gout flare prophylaxis of at least 6 months resp. on reverse. 30mg-28, A29.68; 60mg, 90mgrecommended. 28, A31.49; 120mg-7, A7.88; 28, A31.49. Q Children and adolescents, not S Symptomatic relief of pain and signs of recommended. inflammation associated with acute gouty arthritis. D Initiation during acute gout attack. P 120mg once daily, usually for 7 days. Pregnancy, lactation. Hepatic insufficiency: mild, max. 60mg once daily; B Not recommended: Organ transplant moderate, max. 60mg every other day. recipients (no data), ischaemic heart disease or Q Under 16 years, not recommended. CHF, greatly increased rate of urate formation D Active peptic ulceration or GI bleeding, (e.g. malignant disease, Lesch-Nyhan syndrome) severe hepatic / severe renal dysfunction, IBD, due to risk of xanthine deposition. Monitor liver severe CHF. Aspirin/ant-inflammatory induced function prior to and periodically thereafter. asthma or allergies. Pregnancy or women Caution: Moderate/ severe hepatic impairment, attempting to conceive, lactation. severe renal impairment, altered thyroid function. B Renal or hepatic impairment. History of Driving/ using machines. Contains lactose. ischaemic heart disease, cardiac failure, LV C Avoid mercaptopurine/ azathioprine. dysfunction, hypertension, pre-existing oedema. Caution: Theophylline, potent inducers of History of GI perforation. Elderly. Dehydration. glucuronidation. Monitor patients on anticoagulants. A Headache, diarrhoea, nausea, rash, LFT C Caution: Diuretics, ACE inhibitors, AIIAs, abnormalities. cyclosporin, tacrolimus, lithium, rifampicin, oral contraceptives, HRT, oral anticoagulants, high dose ALOPUR Rowex aspirin or other NSAIDs (avoid), methotrexate, 2MO digoxin, salbutamol, minoxidil. A Dizziness, headache, GI disorders, Xanthine oxidase inhibitor. Allopurinol 100mg, oedema, hypertension, asthenia/fatigue, flu-like 300mg. White biconvex tab., round with singledisease. sided score notch and oblong with both-sided breaking notch resp. 100mg-100, A6.45; 300mgDICLAC Rowex 100, A17.93. S Adults: Hyperuricaemia not controllable 2 M O
2MO
Salicylate-sulphonamide. Sulphasalazine 500mg. Orange/yellow round tab. marked kPh one side and 101 on other. 112, A9.41.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
PROPHYLAXIS AND
Phenylacetic acid. Diclofenac (Na+) 25mg, 50mg. Yellow-brown ent-ctd tabs. 25mg-100, A5.37; 50mg-100, A12.92. S Acute gout. P 100-150mg daily in divided doses. Max. total daily dose should not exceed 150mg. Q Not applicable.
2MO ALSO DICLAC RETARD 75MG Diclofenac (Na+) 75mg (12.5mg immediate release and 62.5mg prolonged release). Two layered, pink and white, prolonged release tab. 60, A15.35. P 1-2 daily. Q Not applicable.
2MO ALSO DICLAC RETARD 100MG Diclofenac (Na+) 100mg. White, round, prolonged release tab. 30, A10.75. P 1 once daily. Q Not applicable.
2MO ALSO DICLAC SUPPOSITORIES Diclofenac (Na ) 100mg. 10, A2.30. P 1 at night alone or in combination with oral admin. Q Not applicable. +
2NO ALSO DICLAC INJECTION Diclofenac (Na+) 25mg/ ml. 3ml amp. 10 x 3ml, A5.61. P 75mg IM once or twice daily by deep intragluteal inj. for 2-3 days. Continue if necessary with tabs. or suppos. Q Not applicable. D Active peptic ulcer. Asthma, aspirin/antiinflammatory induced allergy. Last trimester of pregnancy. Severe hepatic, renal, cardiac failure. B History of GI lesions. Renal or hepatic dysfunction. Pregnancy, lactation. Crohn’s, UC, proctitis. May impair female fertility; not recommended in women attempting to conceive. Tabs contain lactose. C Lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, corticosteroids, diuretics, salicylates. A Transient epigastric pain, nausea. Rash, oedema (discontinue). Rare GI bleeding (discontinue), peptic ulcer. Abnormalities of liver and kidney function.
TREATMENT OF GOUT
5.3
B Renal, severe hepatic or cardiac insufficiency. Lactation. Elderly (prolonged use). Anaphylactic reactions, discontinue if liver function worsens. Medical surveillance in patients with symptoms of GI disorders. Caution: Intracranial haemorrhage and bleeding diathesis, long term treatment. Avoid driving/operating machinery if dizziness or other CNS disturbances occur. C Lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, corticosteroids, diuretics, salicylates, oral hypoglycemic agents, antihypertensives, cardiac glycosides, aminoglycosides, probenecid. A GI disturbances, headache, dizziness, vertigo, rash, elevated liver enzymes.
History of GI disease/toxicity. Risk of GI bleeding, ulceration or perforation. Risk of hypersensitivity reactions. May mask infection. Serious skin reactions have been reported rarely. Renal, cardiac or hepatic impairment. Bleeding abnormalities. Long-term use. May impair female fertility; not recommended in women attempting to conceive. Pregnancy, lactation. C Lithium, digoxin, anticoagulants, antiplatelets, SSRIs, cyclosporin, methotrexate, quinolones, other NSAIDs and steroids, corticosteroid, diuretics, cardiac glycosides, antihypertensives, aminoglycosides, probenecid. A GI disorders, headache, dizziness, vertigo, rashes or skin eruptions, raised ALT, AST.
DIFENE
2MO
2MO
GERINAP EC
Gerard
Astellas Propionic acid. Naproxen 250mg, 500mg. White
Phenylacetic acid. Diclofenac Na+ 25mg, 50mg. Blue/transparent cap. containing ent-ctd pellets, marked D25 and blue/transparent cap. containing ent-ctd pellets, marked D50. 25mg-56, A1.80; 50mg-56, A4.36. S Musculo-skeletal disorders, rheumatoid arthritis, osteo-arthrosis, ankylosing spondylitis, acute gout. Chronic juvenile arthritis. P 75-150mg daily in three divided doses. Max. total daily dose should not exceed 150mg. Q 1-3mg/kg body weight daily in divided doses. Not applicable for gout.
2MO ALSO DIFENE SUPPOSITORIES Diclofenac Na+ 100mg. 10, A1.38. P 1 at night. Q Not applicable.
2MO ALSO DIFENE 100MG DUAL RELEASE Diclofenac 100mg (25mg rapid release and 75mg sust.-release pellets). Blue/transparent cap. marked D100M. 28, A11.93. S Musculosketal disorders, dysmenorrhoea, dental and minor surgery. P 1 once daily. Q Not applicable.
2MO
ALSO DIFENE RETARD DUAL RELEASE Diclofenac Na+ 75mg. Blue/transparent cap. containing entctd, sust.-release pellets, marked D75M. 56, DICLO Pinewood A17.90. 2MO S Musculosketal disorders, dysmenorrhoea, dental and minor surgery. Phenylacetic acid. Diclofenac (sodium) 50mg. Tan P 1 twice daily. circular biconvex ent.-ctd tab. engraved 50/0519 Q Not applicable. on one side. 100, A14.41. 2NO S Acute gout. P 75-150mg daily in 2-3 divided doses, ALSO DIFENE INJECTION Diclofenac Na+ 25mg/ml. with liquid before meals. 3ml amp. 10 x 3ml, A3.36. R Lowest effective dosage in low BW frail S Acute back pain, post-operative pain, patients. renal colic. Q 1-3mg/kg body weight daily in divided P 75mg IM once or twice daily by deep doses. intragluteal inj. for max. 2 days. Post operative 2NO pain: Admin. 75mg IV diluted in 300ml normal ALSO DICLO 75 PROLONGED RELEASE Diclofenac saline and infuse over min. 30 mins.; a second (sodium) 75mg, prolonged release. Round flat dose can be given 8 hours later; max. 2 inf. in 24 two-layered pink and white, prolonged release hrs. Continue if necessary with tabs. or suppos. tabs. 75mg Prolonged Release-60, A15.20. Q Not applicable. S Acute gout. D History of GI bleeding or perforation, P 1 or 2 tabs. daily, taken whole with related to previous NSAID therapy. Active, or liquid. history of, recurrent peptic ulcer/haemorrhage. Q Not recommended. Aspirin/anti-inflammatory induced allergy. Severe D Active peptic ulcer, GI bleeding. Aspirin/ HF. In ulcerative or acute inflammatory conditions other non steroidal anti-inflammatory induced of the anus, rectum (proctitis) and sigmoid colon. allergy. Pregnancy. B Use lowest effective dose. Elderly.
film-ctd. tabs. 250mg-100, A5.19; 500mg-100, A10.40. S Acute gout. P 750mg initially, then 250mg eight hourly. Q Not applicable. D Peptic ulcer disease, active peptic ulcer, intestinal inflammatory disease. Hypersensitivity to naproxen. Aspirin/NSAID induced allergy. B Elderly. History of GI disease. Renal or hepatic impairment. Asthma, allergic disease. Congestive cardiac failure. Platelet aggregation is decreased and bleeding time is prolonged. Pregnancy, lactation. C Anticoagulants, hydantoins, sulphonamides, lithium, b-blockers, methotrexate, probenecid, frusemide. A GI intolerance (nausea, vomiting, epigastic distress), Hypersensitivity/skin reactions (rash, urticaria, anaphylaxis, angio-oedema). Headache, tinnitus, vertigo, blood dyscrasias.
NAPROSYN EC
Roche
2MO Propionic acid. Naproxen 250mg, 500mg. White ent-ctd tab. marked NAPROSYN EC one side, SYNTEX 250 on reverse and oblong white ent-ctd tab. marked NAPROSYN EC and SYNTEX. 250mg56, A3.12; 500mg-56, A6.25. S Acute gout. P 750mg initially then 250mg eight hourly. Q Not recommended. D Active peptic ulcer or GI inflammation. Aspirin/anti-inflammatory induced allergy. B Elderly. History of GI lesions. Renal or hepatic impairment. Asthma. Pregnancy, lactation. C Anticoagulants, hydantoins, sulphonylureas, lithium, b-blockers, methotrexate, probenecid, frusemide. A Rash, GI intolerance, headache, tinnitus, vertigo, blood dyscrasias.
ORUVAIL
sanofi-aventis
2MO Propionic acid. Ketoprofen 200mg. White/pink controlled-release caps. marked with Oruvail 200. 200mg-28, A19.61. S Gout. P 100-200mg once daily with food. Q Not recommended. D Hypersensitivity to NSAIDs. Severe renal or hepatic dysfunction. Active or history of peptic ulcer haemorrage or GI bleeding/perforation related to NSAID therapy. Severe heart failure. 3rd
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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5.4 MUSCLE
RHEUMATOLOGY
SPASM
trimester of pregnancy. B Hypertension. Heart failure. Arterial thrombotic events. Cardiovascular disease. Oedema. GI toxicity. Visual disturbances. Impairment of female fertility. Serious skin reactions. Patients with intracranial haemorrhage and bleeding diathesis. Asthma. Elderly. Driving/ operating machinery. C Not recommended: Anticoagulants, antiplatelet agents, other NSAIDs, SSRIs, lithium, methotrexate. Diuretics, pentoxifylline, corticosteroids, b-blockers, ACE inhibitors and angiotensin II antagonists, amino and cardiac glycosides, cyclosporin, probenecid, thrombolytics, sulphonylureas. A GI intolerance, hypersensitivity reactions, haematology disorders, headache, weight gain, taste perversion, tinnitus, dizziness, paresthesia, convulsions, somnolence, mood disorders, oedema.
VOLTAROL
Novartis Long-acting benzodiazepine. Diazepam 2mg, 5mg,
2MO Phenylacetic acid. Diclofenac Na+ 25mg, 50mg. Yellow ent-ctd tab. and brown ent-ctd tab. Both marked with tab. name and strength one side, GEIGY on reverse. 25mg-84, A8.64; 25mg-100, A5.38; 50mg-50, A6.49. S Acute gout. P 75-150mg daily in two or three divided doses taken with liquid. Q Not applicable.
2MO
ALSO VOLTAROL RETARD Diclofenac Na+ 75mg, 100mg. Pink triangular sust.-release tab. marked CG one side, ID on reverse and red sust.-release tab. marked VOLTAROL R one side GEIGY on reverse. 75mg-30, A11.29; 100mg-28, A14.46; 100mg-30, A15.48. P 1 x 75mg once daily or 1 x 75mg twice daily, alternatively 1 x 100mg once daily. Both PURINOL Pinewood strengths taken whole at mealtime. Q Not applicable. 2MO 2MO Xanthine oxidase inhibitor. Allopurinol 100mg, 300mg. White biconvex tabs. Engraved 1K1or 2K1 ALSO VOLTAROL SUPPOSITORIES Diclofenac Na+ 100mg. 10, A2.31. one side. 100 mg: Breakline on reverse. 100mgP 1 at night. 100, A8.07; 500, A58.20; 300mg-100, A22.39. Q Not applicable. S Urate/Uric acid deposition. Management 2NO of 2,8- DHA renal stones related to deficiency ALSO VOLTAROL INJECTION Diclofenac Na+ activity of adenine phoshoribosyltransferase. 75mg/3ml. Amp. 10 x 3ml, A5.61. Management of recurrent mixed Ca++ oxalate renal stones in presence of hyperuricosuria, when P 75mg IM once or twice daily by deep intragluteal inj. for 2 or 3 days. Continue if fluid, dietary and similar measures have failed. necessary with tabs. or suppos. P Initially 100-300mg daily as a single dose, increasing to maintenance, 200-600mg daily. Q Not applicable. D Active or suspected peptic ulcer. R Use lowest dosage which produces Asthma, aspirin/anti-inflammatory induced allergy. satisfactory urate reduction. B Renal, cardiac or hepatic dysfunction. Q Rarely indicated, except in malignant Elderly. Pregnancy, lactation. Recent proctitis. conditions (especially Leukaemia) and certain enzyme disorders such as Lesch- Nyhan Syndrome. C Lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, D Acute gout. Lactation quinolone antimicrobials, other NSAIDs, B Pregnancy. Elderly. Renal or hepatic dysfunction. Asymptomatic hyperuricaemia. When corticosteroids, diuretics. A Epigastric pain, nausea, headache, initiating therapy always give colchicine or an dizziness, rash, elevation of liver enzymes. anti-inflammatory agent for 1 month. Ensure adequate fluid intake. ZYLORIC Aspen C Anticoagulants, chlorpropamide, 2MO mercaptopurine, azathioprine, vidarabine, Xanthine oxidase inhibitor. Allopurinol 100mg, salicylates and uricosuric agents, didansine, 300mg. White, biconvex, scored tabs. coded ciclosporin, ampicillin/amoxicillin, theopylline. GXCM2 or GXCM7 resp. 100mg-100, A4.84; A Skin reactions (withdraw if occur). 300mg-28, A3.76. Nausea, acute gout. S Gout, prophylaxis of uric acid and TIPURIC Clonmel calcium oxalate stones. P Initially 100mg daily. Maintenance: Mild 2MO conditions, 100-200mg daily. Moderately severe Xanthine oxidase inhibitor. Allopurinol 100mg, conditions, 300-600mg daily. Severe conditions, 300mg. White tabs. marked with logo one side, 700-900mg daily. Max. single dose: 300mg; divide scored and coded 230 or 242 on reverse. 100mgdoses q 300mg. 100, A7.48; 300mg-100, A20.53. Q Under 15 years: 10-20mg/kg/day, max. S Gout, prophylaxis of uric acid and 400mg daily (rarely indicated). calcium oxalate stones. D Acute gout. Lactation. P 100-300mg daily increasing to a B Pregnancy. Elderly. Renal or hepatic maintenance 200-600mg daily. Doses in excess of dysfunction. When initiating therapy also give 300mg should be given in divided doses. colchicine or an anti-inflammatory agent for 1 Q 10-20mg/kg body weight daily. month. Ensure adequate fluid intake. D Acute gout. C Anticoagulants, chlorpropamide, B Pregnancy. Elderly. Renal or hepatic mercaptopurine, azathioprine. dysfunction. When initiating therapy also give A Skin reactions (withdraw if occur). colchicine or an anti-inflammatory agent for 1 Nausea. month. Ensure adequate fluid intake. 5.4 MUSCLE SPASM C Anticoagulants, chlorpropamide, mercaptopurine, azathioprine. ANXICALM Clonmel A Skin reactions (withdraw if occur). Nausea. 2NO
162
10mg. White scored tab. marked D2, yellow scored tab. marked D5, and blue scored tab. marked D10. 2mg-90, A1.01; 5mg-90, A1.54; 10mg-90, A3.81. S Muscle spasm. Cerebral palsy, spasticity. P Muscle spasm: 2-15mg daily in divided doses. Management of cerebral spasticity: 2-60mg daily in divided doses. Q Control of tension and irritability in cerebral spasticity in selected cases: 2-40mg daily in divided doses. Muscle spasm: as for adults. D See SPC. C Compounds which can inhibit certain hepatic enzymes.
BACLOPAR
Gerard
2MO GABA deriv. Baclofen 10mg. White scored tab. marked BN/10 one side and G on reverse. 100, A8.89. S Relief of voluntary muscle spasticity in multiple sclerosis, spinal cord lesions and motor neurone disease. Spasticity of cerebral origin incl. meningitis, cerebral palsy, traumatic head injury, cerebrovascular accident. P Initially 5mg three times daily for 3 days, increasing as required by 5mg three times daily at 3 day intervals. Max. 100mg daily. Q Under 12 months, not recommended; 110 years, 0.75-2mg/kg body weight daily; over 10 years, max. 2.5mg/kg daily. Maintenance: 1-2 years, 10-20mg daily; 2-6 years, 20-30mg daily; 610 years, 30-60mg daily. The daily dose should be given in at least 4 divided doses. D Pulmonary insufficiency. B Psychotic disorders, schizophrenia, confused states, epilepsy, history of convulsions. Cerebrovascular disease, peptic ulcer, renal or hepatic impairment. Urinary sphincter hypertonia. Pregnancy. Withdraw drug gradually. Monitor blood sugar and liver function. Ability to drive or operate machinery may be impaired. C Other CNS acting drugs, alcohol, fentanyl, TCADs, antihypertensives, levodopa, ibuprofen. A Sedation, drowsiness, nausea. Neurological and/or psychiatric manifestations. Hypotension, dysuria, frequency of micturition, enuresis. Paradoxical increased spasticity.
BOTOX
Allergan
2N Bacterial toxin. Clostridium botulinum type A neurotoxin complex 100 units. Powder in vial for sln for inj. 1, A205.69. S Blepharospasm, hemifacial spasm, associated focal dystonias, spasmodic torticollis. Focal spasticity: a) associated with dynamic equinus foot deformity due to spasticity in paediatric cerebral palsy patients r2 years; b) of wrist and hand in adult post stroke patients. Persistent severe primary hyperhidrosis of the axillae resistant to topical treatment. P 0.05-0.1ml (blepharospasm, hemifacial spasm) or 0.1-0.5ml (cervical dystonia, cerebral palsy) inj. in muscle site. 0.1-0.2&nbspâľ per intradermal inj. in primary axillary hyperhidrosis. See SPC. Q Cerebral palsy: Hemiplegia, initially 4 units/kg body weight in the affected limb. Diplegia, initially 6 units/kg body weight divided between the affected limbs. Total dose 200 units max. D Lactation, pregnancy (unless essential).
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
MUSCLE
Infection at inj. sites. B History of dysphagia and aspiration, neurological disorders including swallowing difficulties, peripheral motor neuropathic diseases, neuromuscular disorders. Angle closure glaucoma (blepharospasm). C Aminoglycoside antibiotics, spectinomycin, or other drugs interfering with neuromuscular transmission. A Dysphagia, muscle weakness, pain. Blepharospasm: Eyelid ptosis, other eye disorders. Cervical dystonia: URI, dizziness, hypertonia, hypoaesthesia, somnolence, headache. Cerebral palsy: Viral infection, ear infection, somnolence, paraesthesia, urinary incontinence, rash, gait disturbance.
DANTRIUM
SpePharm
2MO Hydantoin. Dantrolene Na+ 25mg, 100mg. Orange/ light brown cap. marked 0030 and orange/light brown cap. marked 0033. 25mg-100, A18.50; 100mg-100, A64.66. S Chronic, severe spasticity in stroke, multiple sclerosis, spinal cord injury and cerebral palsy. P Initially 25mg daily increasing gradually as required to max. 100mg four times daily. Titrate dose for each patient. See SPC. Q Not recommended. D Hepatic dysfunction. Where spasticity is useful for locomotion. Pregnancy, lactation. B Pregnancy. Impaired pulmonary or cardiac function. Perform liver tests before, and 6 weeks after commencing treatment. C Alcohol, CNS depressants. A Weakness, fatigue, drowsiness, diarrhoea.
DYSPORT
Ipsen
2N Bacterial toxin. Botulinum toxin Type Ahaemagglutinin complex 500 units. Powder in vial. Vial-2, A487.45. S Blepharospasm, hemifacial spasm, spasmodic torticollis. Paediatric cerebral palsy spasticity. Adult arm spasticity. P Doses are not interchangeable with other preps. of botulinum toxin; see SPC. Q See lit. D Pregnancy, generalised muscle disorders. See SPC. B Should only be used by specialists. See SPC.
LIORESAL
Novartis
2MO GABA deriv. Baclofen 10mg. White tab.scored and marked KJ one side, C-G on reverse. 100, A5.34.
2M ALSO LIORESAL ORAL SOLN. Baclofen 5mg/5ml. Sugar-free. 300ml, A7.21. S Voluntary muscle spasticity due to cerebrovascular accidents, cerebral palsy, meningitis, multiple sclerosis, spinal lesions. Treatment should not be started until spastic state has become stabilised. P Initially 5mg three times daily, increasing as required by 5mg three times daily at 3 day intervals. Max. 100mg daily. Q 0.75-2mg/kg body weight. Initially: 2.5mg four times daily, increased at 3 day intervals to maintenance dose. Maintenance: 12 months-2 years, 10-20mg daily; 2-10 years, 30-60mg daily.
The daily dosage should be given in at least 4 divided doses. D Respiratory impairment. B Psychotic disorders, schizophrenia, confusional states. Epilepsy, peptic ulcer disease, cerebrovascular disease, hepatic or renal impairment. Urinary spincter hypertonia. Pregnancy. Withdraw drug gradually. Monitor blood sugar and liver function. C Lithium, tricyclic antidepressants, anithypertensives, levodopa, carbidopa, fentanyl, ibuprofen. A Sedation, drowsiness, nausea. Neurological and/or psychiatric manifestations. Hypotension. Dysuria, frequency or enuresis. Muscle fatigue. Epileptic attacks, visual disturbances, skin rash.
SPASM
5.4
2NO
Central a2-agonist. Tizanidine 2mg, 4mg. White, round tab. marked N62 or N63 resp. 4mg scored on reverse. 2mg-120, A66.69; 4mg-120, A83.37. S Spasticity associated with MS or with spinal cord injury / disease. P Initially 2mg increasing in 2mg increments at not less than half-weekly intervals. Optimum therapeutic response: 12-24mg daily, in 3 or 4 equally spaced doses. Single doses, 12mg max. Max 36mg/day. Renal insufficiency: Initially, 2mg once daily with slow titration to achieve effective dose; dose increases in 2mg increments max. according to tolerability and effectiveness. R Not recommended. Q Not recommended. D Significantly impaired hepatic function. Pregnancy (unless benefit outweighs risk), NEUROBLOC Eisai lactation. B Hypotension may occur. Withdraw 2N gradually. Caution: Renal impairment, Botulinum toxin. Botulinum toxin type B 5000 U/ ml. sln for injection. 2500 U-0.5ml, A152.55; 5000 cardiovascular disorders, coronary artery disease or renal or hepatic disorders. Monitor liver function U-1ml, A203.40; 10000 U-2ml, A271.19. before and during treatment. Contains lactose. S Cervical dystonia (toricollis). P Initially 10000 U IM divided between 2-4 C Contra: Strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin). Not recommended: most affected muscles. CYP1A2 inhibitors e.g. some antiarrhythmics R See lit. (amiodarone, mexiletine, propafenone), Q Not recommended. cimetidine, some fluoroquinolones (enoxacin, D Other neuromuscular disease or pefloxacin, norfloxacin), rofecoxib, oral neuromuscular junctional disorders. Pregnancy, contraceptives, ticlopidine. Caution: Substances lactation. increasing QT interval, antihypertensives, alcohol. B Bleeding disorders or anticoagulant A Bradycardia, tachycardia, drowsiness, therapy. Do not inject into a blood vessel. fatigue, dizziness, GI disorders, BP reduction, C Co-administration of NeuroBloc and rebound hypertension. aminoglycosides or agents interfering with neuromuscular transmission should be considered TIZANIDINE (INN) Niche with caution. A Dry mouth, dysphagia, worsening 2NO torticollis, myasthenia. Central a2-agonist. Tizanidine 2mg, 4mg. White, round tab. marked resp. N62 or N63 on one side. QUININE SULPHATE Actavis 4mg scored on other side. 2mg-120 A63.33; 4mg120, A73.95. 2MO Blood schizontocide. Quinine sulphate 300mg. VALIUM Roche White, circular sug-ctd tab. marked QD and C on 2NO one side. 28, A8.41. S Treatment and prevention of nocturnal Benzodiazepine. Diazepam 5mg. Scored yellow leg cramps in adults (indication contraindicated in tab.and marked with 5 and ROCHE. 5mg-100, A1.08. pregnancy). S Muscle spasm, epilepsy. P 300mg at bedtime. May take up to 4 weeks to be effective. Closely monitor patients in P Elderly, 1-30mg daily; others, 2-60mg daily. Both in divided doses. See SPC. the early stages of treatment. Reassess treatment Q 2-40mg daily in divided doses. at 3 months intervals. D See SPC. D Red blood cell enzyme deficiencies, Hburia, optic neuritis, tinnitus, fructose ZANAFLEX Cephalon intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. 2NO B Caution: Atrial fibrillation or other Central a2-agonist. Tizanidine (HCl) 2mg, 4mg. serious heart disease, myasthenia gravis, glucose-6- White tabs. cross-scored marked with logo and phospate dehydrogenase deficiency, inadequately coded 592 or 594. 2mg-120 A42.56; 4mg-120 control malarial infection. Driving, operating A53.21. machinery. Pregnancy, lactation. S Spasticity associated with multiple C Amiodarone, flecainide, quinidine, sclerosis, spinal cord injury or disease. anticoagulants, terfenadine, other anti-malarial P Initially 2mg increasing in 2mg (chloroquine, artemether with lumefantrine, increments at not less than 3-4 day intervals. Give mefloquine), pimozide or thioridazine, cardiac in divided doses 3 or 4 times daily. Titrate glycosides, cimetidine. according to response, usually up to 24mg daily; A Blood disorders, hypersensitivity max. 36mg daily in divided doses. reactions, acute renal failure, hypoglycaemia, Q Not recommended. cardiovascular effects, cinchonism (tinnitus, D Hepatic impairment. headache, nausea, abdominal pain, flushing, rash, B Renal impairment. Pregnancy, lactation. visual disturbance, confusion), muscle weakness, Exclude liver disease. deafness, vomiting, pruritis, excitement. C Diuretics, b-blockers, antihypertensives, digoxin, oral contraceptives, alcohol. TIZAFLEX Actavis A Drowsiness, fatigue, dizziness, dry
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
163
5.5 TOPICAL
AND INTRA-ARTICULAR ANALGESIA
RHEUMATOLOGY
mouth, GI upset, hypotension, insomnia, bradycardia, hallucinations.
ALSO DIFENE GEL Diclofenac Na+ 1%. Gel. 50g, A1.67. S Local symptomatic relief of pain and 5.5 TOPICAL AND INTRA-ARTICULAR inflammation in joints, tendons, muscles, ligaments and soft tissue injury. ANALGESIA P 2-4g (2-2.5 cm) applied 2-4 times daily. AULIN GEL Helsinn Birex Q Not recommended. D Aspirin/anti-inflammatory induced 2MO allergy. Last trimester of pregnancy. Lactation. Selective COX-2 inhibitor. Nimesulide 3%. Gel. B Should only be admin. to intact skin. 50g, A1.48. Avoid contact with mucous membranes, eyes or S Symptomatic relief of pain associated oral use. Photosensitivity. Precaution with large with sprains and acute traumatic tendinitis. areas of skin/prolonged use (to avoid systemic P 3g (6-7cm) rubbed into affected area 2 effects). First 6 months of pregnancy. or 3 times daily. Duration 7-15 days. C Other NSAIDs. Q Under 12 years, contraindicated. A Local allergic skin reactions. D Aspirin/anti-inflammatory induced Photosensitivity (rare). allergy. Skin wounds or infections. Pregnancy, lactation (unless clearly necessary). Meda B GI bleeding, peptic ulcer, severe renal / DIFFLAM CREAM 2O hepatic dysfunction, severe coagulation disorders or severe/non controlled HF. Exposure to direct Analgesic-anti-inflammatory. Benzydamine (HCl) and solarium sunlight. 3%. Cream. 50g, A5.32. A Itching, erythema. S Musculo-skeletal and rheumatic pain. V 1-2.5g massaged in lightly three times AXSAIN Cephalon daily; up to 6 times daily in severe cases. D Pregnancy, lactation (unless essential). 2MO B Donâ&#x20AC;&#x2122;t apply to eyes or mucosal surfaces. Topical analgesic. Capsaicin 0.075%. Cream. 45g, Risk of allergic reactions to some excipients. A16.22. S Post-herpetic neuralgia and painful DUROLANE Smith & Nephew diabetic neuropathy. Hyaluronan. Non-animal, stabilised, hyaluronic P Apply sparingly 3-4 times daily. acid 60mg. Sterile, transparent viscoelastic gel Q Not recommended. supplied in a 3ml glass syringe. 20mg/ml-1, A307. D Broken or irritated skin. S Symptomatic treatment of mild to B Keep away from eyes. moderate knee or hip osteoarthritis. A Transient burning on application. Before or after applying Axsain, avoid hot bath or P 3ml intra-articularly per knee or hip joint. shower. B Not recommended: Infected or severely DICLAC GEL 1% Rowex inflamed knee or hip joint, presence of active skin disease or infection at or near the injection site. 2MO NSAID. Diclofenac (Na+) 1% w/w. Gel. 50g, A2.78. Should not be injected intravascularly or extraarticularly or in the synovial tissues or capsule. 2K Caution: Venous or lymphatic stasis in the leg. Use ALSO DICLAC RELIEF Diclofenac (Na+) 1% w/w. a separate syringe or each knee or hip. Small risk Gel. 30g, A3.30. of infection. Pregnancy, lactation. S Pain and inflammation in trauma of the A Mild and transient arthralgia. tendons, ligaments, muscles and joints e.g. due to sprains, strains and bruises. Localised forms of soft ETOFLAM Phoenix tissue rheumatism. 2MO P Massage 2-4g (3-4 times daily). Flufenamic acid derivative. Etofenamate 5%. A Q Under 12 years, not recommended. nearly transparent yellowish gel. 100g, A8.46. D Aspirin/anti-inflammatory induced S Inflammatory disorders of the musculoallergies. Patients in whom attacks of asthma, skeletal system. urticaria or acute rhinitis are precipitated by P Topical use only. Apply a 5-10cm strip of NSAIDs. Pregnancy, lactation (no experience). gel (according to the area affected) and rub B Avoid broken skin, occlusive dressings, eyes and mucous membranes. History of, or active gently. peptic ulceration. Can precipitate bronchoplasm in Q Not recommended. D Hypersensitivity to NSAIDs including patients with bronchial asthma. aspirin. Use with: Occlusive dressings; any other C Other drugs containing diclofenac topical preparation on the same site. Local (avoid). Caution: Oral NSAIDs. infection, broken skin. Pregnancy, lactation. A Itching, mild local reactions, rash, B Contains alcohol (avoid contact with isolated photosensitivity reactions. eyes/mucous membranes). Wash hands after use. DIFENE SPRAY GEL Astellas Do not apply to irritated/broken skin. If irritation develops discontinue. Consult doctor if no 2MO Topical NSAID. Diclofenac Na+ 40mg/1g soln. (4%). improvement/aggravation develops. Golden-yellow transparent soln. 30ml, A8.06. EUFLEXXA Ferring S Local symptomatic relief of mild to moderate pain and inflammation following acute O blunt trauma of small and medium-sized joints Hyaluronan. Hyaluronic acid (Na+ salt) 10mg/ml. and periarticular structures. Soln in prefilled syringe. 1, A155.61. P 4-5 sprays 3 times daily. S Pain caused by osteoarthritis of the Q Under 15 years, not recommended. knee. 2MO P 2ml injected into the affected knee
164
once weekly for 3 weeks, for a total of 3 injections. D Knee joint infection, infections in inj. site area or skin disease. A Arthralgia and joint swelling.
FASTUM
A. Menarini
2MO NSAID. Ketoprofen 2.5%. Gel. 100g, A6.68. S Local relief of pain and inflammation associated with rheumatic and muscular disorders and soft tissue injuries, strains and sprains. (Tablet presentation see Keral). P Usually 5-10cm gel applied 2 or 3 times daily for up to 10 days. Massage area after application. Q Not recommended. D Aspirin/anti-inflammatory induced allergies, history of asthma. B Renal impairment. Pregnancy, lactation. A Mild local reactions.
FELDENE GEL
McNeil Healthcare
2KO NSAID. Piroxicam 0.5%. Clear gel. 60g, A5.95. S Osteoarthritis, acute musculo-skeletal disorders such as tendinitis, periarthritis, bursitis, post-traumatic conditions, sprains and low back pain. P 1g (3cm) rubbed into affected site 3-4 times daily. Q In juvenile chronic arthritis it is recommended that Feldene Dispersible tabs. are used. D Aspirin or NSAID induced symptoms of asthma, rhinitis or urticaria. Open skin lesions, dermatoses or infection. Use in children in the absence of experience. B Use min. effective dose for shortest possible duration. History of or existent peptic ulceration, intestinal inflammatory disease, renal dysfunction, hepatic disease, elderly. Monitor patients on prolonged therapy. May prolong bleeding time and decrease platelet aggregation. Pregnancy, lactation. Discontinue if local irritation develops. A Mild or moderate local application site reactions.
HYALGAN
Fidia
2NO Hyaluronan. Hyaluronic acid (sodium salt) 20mg/ 2ml. Soln. in pre-filled syringe. 1, A38.02. S Sustained relief of pain in osteoarthritis of the knee. P 2ml by intra- articular inj. once weekly to a total of 5 inj. Course may be repeated at not less than 6 monthly intervals. Q Not recommended. D Hypersensitivity to avian proteins. Infection or skin disease at inj. site. B Remove joint effusion prior to inj.. Pregnancy, lactation. C Quaternary ammonium disinfectants. A Transient pain, swelling and heat at inj. site.
IBUGEL
Dermal
2MO NSAID. Ibuprofen 5%. Gel. 100g, A7.05. S Backache, rheumatic and muscular pain, sprains, strains and neuralgia. Also for common arthritic conditions. P Massage in up to 3 times daily. Review
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
TOPICAL
AND INTRA-ARTICULAR ANALGESIA
S Backache, muscular and rheumatic pain, sprains, strains and sports injuries. P Apply thin layer of gel to affected area 3 times daily for up to 7 days. Q Under 12 yrs, contraindicated. D Hypersensitivity reactions to NSAIDs. Eczema, acne, infectious skin or open wounds. Active peptic ulceration. Use with occlusive MESULID GEL Ergha dressings. Simultaneous use to same site with other topical cream. 3rd trimester of pregnancy, 2MO lactation. Selective COX-2 inhibitor. Nimesulide 3%. Gel. B Renal, cardiac or hepatic impairment. 50g, A1.43. Rash. Pregnancy. Avoid broken skin, eyes and S Symptomatic relief of pain associated mucous membranes. Direct sunlight or solarium with sprains and acute traumatic tendinitis. should be avoided. Elderly. History of peptic ulcer P 3g (6-7 cm) rubbed into affected area or IBD, intracranial haemorrhage or bleeding two or three times daily. Duration 7-15 days. diathesis. Q Under 12 years, contraindicated. A Mild local irritation. Erythema, pruritus, D Aspirin/anti-inflammatory induced photosensitivity reactions. allergy. Pregnancy, lactation (unless clearly necessary). Use on skin wounds or infections. PHORPAIN Goldshield B Avoid contact with eyes, mucous membranes. GI bleeding, peptic ulcer, severe renal 2 O or hepatic dysfunction, severe coagulation NSAID. Ibuprofen 5%. Gel. 100g, A3.77. disorders or severe/non controlled HF. Exposure to S Systemic relief of backache, rheumatic direct and solarium sunlight. and muscular pain, sprains, strains and neuralgia. A Itching, erythema. P Massage in up to 3 times dailly. Review therapy after 2 weeks. NUROFEN GEL Reckitt Benckiser Q Not recommended. D Aspirnin/anti-inflammatory induced 2 allergies. History of asthma. Pregnancy, lactation. NSAID. Ibuprofen 5% WW gel. Gel. 30g, A4.29. S Pain and inflammation in the trauma of B Avoid broken skin, occlusive dressings, eyes and mucous membranes. the tendons, ligaments, muscles and joints and in A Mild local irritation, rash. localised forms of soft tissue rheumatism. P Apply to affected area and massage in SPORTVIS Movianto up to 3 times a day. Review treatment after 2 Hyaluronan Hyaluronic acid (Na+ salt), 1%. Clear weeks. A sln in prefilled syringe. 2, 139.50. Q Under 14 years, not recommended S To relieve pain and optimise recovery of except under medical advice. the ankle following first or second degree sprain. D Aspirin/anti-inflammatory induced P 1 peri-articular inj. within 48 hours of allergies. ankle sprain injury followed by a 2nd inj. 2-3 days B Avoid eyes, mucous membranes, after the 1st inj. inflamed or broken skin, occlusive dressings. Discontinue if rash develops. Pregnancy, lactation. B Should only be injected by healthcare professionals trained in the procedure. Must not C Aspirin or other NSAIDs. be injected into blood vessels. Do not inject if inj. A Application site reactions, rashes, site is inflamed, infected or if evidence of acute or pruritis, urticaria, abdominal pain, dyspepsia. chronic skin disease. Consider potential risks ORUGESIC GEL sanofi-aventis associated with inj. of any biological material. Do not reuse needles. Pregnancy, lactation. 2MO A Mild erythema. Propionic acid. Ketoprofen 2.5%. 50g, A3.40. S Pain and inflammation associated with SUPLASYN Premier Medical soft tissue trauma, osteoarthritis and extraO articular rheumatism. P Apply 2-4 times daily for up to 6 weeks. Hyaluronan. Hyaluronic acid (Na+ salt) 20mg/2ml. Soln in prefilled syringe. 1, A50.70. S As replacement for synovial fluid Q Under 12 years, contraindicated. D Hypersensitivity reactions. Eczema, acne, following arthrocentesis beneficial in osteoarthritis infectious skin or open wounds. Active peptic for management of pain and improvement in ulceration. Use with occlusive dressings. physical function of joints. Simultaneous use to same site with any topical P Up to 2ml may be admin. intracream. 3rd trimester of pregnancy, lactation. articularly. 1 inj. per week for 3 weeks, but up to B Renal, cardiac or hepatic impairment. 6 may be given in chronic conditions. Discard any Rash. Avoid broken skin, eyes and mucous unused portion. membranes. Direct sunlight or solarium should be A Transient pain, mild local reaction. avoided. Elderly. History of peptic ulcer or IBD, intracranial haemorrhage or bleeding diathesis. SYNVISC Genzyme Pregnancy. Hyaluronan derivative. Hylan G-F 20, 2ml. 1 A Mild local irritation. Erythema, pruritus, syringe, A88; 3 syringes, A264. photosensitivity reactions. P Osteoarthritis of the knee. 3 inj. in the knee, with an interval of 1 week between each ORUVAIL GEL sanofi-aventis inj. For max. effect, it is essential to admin. all 3 2 inj. Max. recommended dosage, 6 inj. within 6 NSAID. Ketoprofen 2.5%. 30g, A4.20; 10 x 30g, months, with 4 weeks minimum between A39.00. treatment regimens. Osteoarthritis of the hip /
therapy after a few weeks. Q Not recommended. D Aspirin/anti-inflammatory induced allergies. History of asthma. Pregnancy, lactation. B Avoid broken skin, occlusive dressings, eyes and mucous membranes. A Mild local irritation, rash.
5.5
ankle / shoulder. Initially, single inj. If adequate symptomatic relief not achieved, 2nd inj. recommended (between 1 and 3 months after 1st inj.). Q Not recommended. ALSO SYNVISC-ONE Hylan G-F 20, 6ml. 1 syringe, A264. S Temporary replacement and supplement for synovial fluid. P Osteoarthritis of the knee. One inj. in the knee. May be repeated 6 months after. Q Not recommended. D Venous or lymphatic stasis. Infected or severely inflamed joints, skin diseases or infections in the area of the injection site. Hypersensitivity to avian proteins. B Do not inject IV, extra-articularly or into synovial tissues and capsule. Do not use in case of large intra-articular effusion prior to injection. Pregnancy. C Avoid disinfectants containing quaternary ammonium salts for skin preparation. A Transient pain and/or, swelling and/or effusion in the injected joint.
TRANSVASIN
Thornton & Ross
2K Rubefacient. Tetrahydrofurfuryl salicylate 14%, ethyl nicotinate 2%, hexyl nicotinate 2%. Cream. 40g, A1.64. S Rheumatic and muscular pain, strains and sprains. V Massage in gently at least twice daily. B Broken or sensitive skin, mucous membranes. A Localised sensitisation reactions.
TRAXAM GEL
Goldshield
2MO NSAID. Felbinac 3%. Gel. 7.5g, A1.78; 100g, A10.21.
2MO ALSO TRAXAM FOAM Felbinac 3.17%. Upon actuation, aerosol. 100g, A11.52. S Soft tissue injury. Extra-arthricular rheumatics. P Rub 1g lightly into affected area 2-4 times daily. Q Not recommended. D Aspirin/anti-inflammatory induced allergy. B Avoid occlusive dressings, mucous membranes, eyes. Use only on intact skin. Pregnancy, lactation. A Mild local erythema, dermatitis, pruritus.
VOLTAROL EMULGEL Novartis Consumer
2M Diclofenac diethylammonium equiv. diclofenac Na+ 1% w/w. Gel. 30g, A4.38. S Trauma of the tendons, ligaments, muscles and joints, eg. due to sprains, strains and bruises; soft tissue rheumatism. P 2-4g gel rubbed gently into affected area 3 or 4 times daily. Max. duration 7 days. Q Not recommended.
2MO ALSO VOLTAROL EMULGEL Diclofenac diethylammonium equiv. diclofenac Na+ 1% w/w. Gel. 50g, A1.67. S Trauma of the tendons, ligaments, muscles and joints, eg. due to sprains, strains and bruises; soft tissue rheumatism. Osteoarthritis of
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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5.6 MYASTHENIA
RHEUMATOLOGY
GRAVIS
superficial joints such as the knee. P 2-4g gel rubbed gently into affected area 3 or 4 times daily (max. 6 weeks). Review treatment after 14 days, in OA review after 4 weeks. Q Not recommended. D Aspirin/anti-inflammatory induced allergy. B Use only on intact skin. Avoid occlusive dressings, eyes and mucosa. Pregnancy, lactation (not recommended). A Itching, skin rash. Rarely photosensitivity reactions.
embolism. Age Q 18 or incomplete bone/testicular development. B See SPC. C See SPC. A See SPC.
CAVERJECT
P 1 vial (11.25mg) as single IM inj. at 3 month intervals. See SPC. Q Not applicable. D Pregnancy. A Site reactions, arthralgia. Mild or moderate withdrawal bleeding in girls (1st Pharmacia month).
2NO
Prostaglandin. Alprostadil 5mcg, 10mcg, 20mcg. Powder and solvent for soln. 5mcg-1, A6.89; 10mcg-1, A8.25; 20mcg-1, A10.74. S Treatment and diagnosis of erectile dysfunction. P Initially 2.5mcg by intracavernous inj. If ZACIN Cephalon necessary increase in 2.5mcg increments to max. 2MO 60mcg. Max. once daily and 3 times per week. Q Not applicable. Topical analgesic. Capsaicin 0.025%. Cream. 45g, A16.22. D Sickle cell anaemia, multiple myeloma, leukaemia. Penile angulation or fibrosis. Petronieâ&#x20AC;&#x2122;s S Symptomatic relief of pain associated disease. with osteoarthritis. B Advise patients to seek medical P Apply sparingly 4 times daily. attention if erection persists q 4 hours. Q Not recommended. C Warfarin, heparin. D Broken or irritated skin. A Penile pain, priapism, fibrosis, B Keep away from eyes. Before or after angulation, inj. site reactions, headache, applying Zacin, avoid hot bath or shower. hypertension, dizziness. A Transient burning on application.
GONAL-F
Merck Serono
2N
Gonadotrophin. Follitropin alfa 75 IU (5.5mcg)/ml, 300 IU (22mcg)/0.5ml; 450 IU (33mcg)/0.75ml, 900 IU (66mcg)/1.5ml, 1050 IU (77mcg)/1.75ml. Single/ multidose vials or pre-filled pen. Single dose: 75 IU-1, A38.20; 5, A192.67. Multidose: 450 IU-1, A231.20; 1050 IU-1, A539.48. Pre-filled pen: 300 IU-1, A162.55; 450 IU-1, A243.83; 900 IU-1, A487.66. S Stimulation of spermatogenesis in men with congenital or acquired hypogonadotrophic hypogonadism in combination with human Chorionic Gonadotrophin (hCG). P 150 IU three times a week, concomitantly with hCG, for minimum 4 months. 18 months may be necessary. D Pituitary or hypothalamus tumours. Primary testicular insufficiency. 5.6 MYASTHENIA GRAVIS CIALIS Lilly B Semen analysis recommended 4 to 6 months after beginning of treatment. MESTINON Meda 2 N O A Gynaecomastia, acne, weight gain. Phosphodiesterase type 5 inhibitor. Tadalafil 2MO 10mg, 20mg. Film-ctd almond-shaped tabs. light GONAPEPTYL DEPOT Ferring Anticholinesterase. Pyridostigmine bromide 60mg. yellow marked C10 and yellow marked C20, resp. White quarter-scored tab. marked ICN. 200, 6NT 10mg-4, A25.79; 20mg-4, A25.79. A53.85. S Treatment of erectile dysfunction. In Gn-RH analogue. Triptorelin (acetate) 3.75mg. S Myasthenia gravis. order to be effective, sexual stimulation is Powder and solvent for inj. prolonged release in P Usually 5-20 tabs. daily in divided doses. required. Not indicated for use by women. pre-filled syringe. 1, A183.98. Q Neonates, 5-10mg four hourly. Under 6 P Males:10mg taken at least 30 min S Precocious puberty (girls under 9 years, years, initially 30mg; 6-12 years, initially 60mg before sexual activity. The dose may be increased boys under 10 years). increasing by 15-30mg daily until control. to 20mg if 10mg does not produce adequate Q One inj. on days 0, 14, and 28 by SC or D Intestinal or urinary obstruction. effect. Efficacy may last for up to 36 hrs post-dose. deep IM inj. Thereafter one every 28 days; if effect B Bronchial asthma, cardiac disease, Severe renal impairment, 10mg max. Continuous insufficient, inj. may be given every 21 days. Dose vagotonia, epilepsy, Parkinsonism. daily use not recommended. should be based on body weight: Q20kg, half C Depolarising muscle relaxants, Q Under 18 years, not recommended. dose; between 20-30kg, (2/3 dose); q30kg, full cyclopropane, halothane. D Co-admin. with nitrates, cardiac disease dose. A Nausea, salivation, diarrhoea, colic. when sexual activity is inadvisable, MI within 90 D Progressive brain tumours. days, unstable angina or angina occurring during B Preclude pseudo-precocious puberty and 6.1 HYPOGONADISM, ERECTILE sexual intercourse, HF, uncontrolled arrhythmias, gonadotropin-independent precocious puberty. DYSFUNCTION, OTHER SEXUAL hypotension, uncontrolled hypertension, stroke Allergic and anaphylactic reactions reported. within 6 months, loss of vision in one eye caused C Oestrogen. DISORDERS by non-arteritic anterior ischaemic optic A Bone pain, libido decreased, hot flushes, ANDROCUR 100 Bayer Schering neuropathy (NAION). dysuria, impotence, mood changes, headache, B Medical history/physical examination vaginal disorders, perspiration. Hypersensitivity, 2NO depressive mood, irritability, nausea, myalgia, Anti-androgen. Cyproterone (acetate) 100mg. Off- should be undertaken to diagnose erectile dysfunction. Consider cardiovascular status of arthralgia, tiredness, sleep disorders, inj. site pain/ white cap.-shaped scored tab. marked LA each patient prior to treatment. Serious cardiovascular reaction, gynecomastia. side of score, hexagon on reverse. 60, A82.14. events reported. May induce a BP decrease. Visual S Severe hypersexuality and sexual LEVITRA Bayer Schering defects and cases of NAION may occur. Severe deviation in the male. Prostatic carcinoma. Hot hepatic impairment. Renal insufficiency (not 2NO flushes. recommended). Conditions which predispose Phosphodiesterase type 5 inhibitor. Vardenafil P Severe hypersexuality and sexual patients to priapism (sickle cell anaemia, multiple 5mg, 10mg, 20mg. Orange film-ctd tabs. marked deviation in males: usually 50mg morning and myeloma, leukaemia). Continuous daily use not with BAYER cross one side and 5, 10 or 20 on evening. Hot flushes: 100mg daily, increase to recommended. Contains lactose. reverse. 5mg-4, A20.93; 10mg-4, A24.40; 20mg-4, 200mg if necessary. Prostatic carcinoma, C Not recommended: a-blockers, other ED A29.64. monotherapy: 100mg twice or three times daily. treatments. CYP3A4 inhibitors, CYP3A4 inducers. S Erectile dysfunction. Reduction of LHRH agonist tumour flare: initially P 10mg taken approx. 25-60 mins. before 100mg twice daily alone for 5-7 days, followed by A Headache, dizziness, palpitations, flushing, nasal congestion, GI disorders, back pain, sexual activity. May be increased to 20mg or 100mg twice daily for 3-4 weeks, with LHRH decreased to 5mg. Max. dose 20mg; max. agonist in dosage recommended by manufacturer. myalgia. frequency, once daily. Mild and moderate hepatic Elimination of effect of adrenocortical androgens DECAPEPTYL 3 MONTHS Ipsen impairment/severe renal impairment: Consider with LHRH agonist/orchiectomy: 100mg once or 6 N T 5mg initially; moderate hepatic impairment: Max. twice daily. Gn-RH analogue. Triptorelin 11.25mg. Powder in 10mg. Q Not applicable. vial plus 2ml diluent. 1, A431.71. R Initially 5mg. D Acute liver disease. Malignant/wasting S Precocious puberty (onset before 8 years Q Under 18 years, not recommended. diseases (other than prostatic carcinoma); severe D Cardiac disease for whom sexual activity in girls and 9 years in boys). chronic depression; history of thrombosis/
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES
HYPOGONADISM, ERECTILE
is inadvisable, severe hepatic impairment, end stage renal disease requiring dialysis, hypotension, recent MI or stroke, unstable angina, hereditary retinal degenerative disorders. Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy. Use by women. B Consider potential underlying causes of ED. Anatomical deformation of penis, conditions which predispose to priapism (sickle cell anaemia, multiple myeloma, leukaemia). Bleeding disorders, active peptic ulcer. Sudden visual defect, discontinue and consult physician immediately. C Nitrates or nitric oxide donors, ketoconazole and itraconazole (men q75 years), protease inhibitors. Avoid potent CYP3A4 inhibitors, grapefruit juice, antiarrhythmic medications class 1A or III, other treatment for ED. Avoid: Nicorandil. Caution: a-blockers (concomitant use: At lowest vardenafil starting dose; dose separation recommended, See SPC), erythromycin. A Flushing, headache, dyspepsia, nausea, dizziness, rhinitis.
MUSE
DYSFUNCTION, OTHER SEXUAL DISORDERS
Meda
2NO Prostaglandin. Alprostadil 125, 250, 500, 1000mcg. Transurethral delivery system. 125mcg-1, A10.38; 6, A62.30; 250mcg-1, A11.08; 6, A66.50; 500mcg1, A11.99; 6, A71.94; 1000mcg-1, A12.94; 6, A77.59. S Treatment and diagnosis of organic erectile dysfunction. P Initially 250mcg by intraurethral admin. Increase or decrease for subsequent dose according to response. Max. 2 doses in 24 hours; 7 doses in a 7 day period. Patient must urinate first to facilitate admin. Q Not applicable. D Abnormal penile anatomy, balanitis, acute/chronic urethritis, sickle cell anaemia, thrombocythaemia, polycythaemia, multiple myeloma, predisposition to venous thrombosis or a history of recurrent priapism. Use in men for whom sexual activity is inadvisable. B Advise patient to seek medical attention if erection persists q 4 hours. Condom should be
PRESCRIBING NOTES ERECTILE DYSFUNCTION (ED) Erectile dysfunction (impotence): Inability to achieve/maintain an erection adequate for sexual satisfaction. Causes may be psychological, organic. Risk factors: Ageing, diabetes mellitus, hypertension, haemochromatosis, alcoholism, smoking, drugs (e.g. beta-blockers, thiazides, SSRIs, TCAs, phenothiazines). Psychological causes: Stress, depression, anxiety about sexual performance. Organic causes: Hypogonadism, neurological dysfunction (e.g. multiple sclerosis, radical prostatectomy), peripheral vascular disease, penile abnormality. Prevalence: One of the most common chronic medical disorders in men over age 40. Prevalence and severity increases with age. It is estimated that over 100 000 Irish men suffer from ED. Assessment: Detailed medical and sexual history is essential. Basic examination: Blood pressure measurement, genital examination. Further examination/investigations or referral indicated by age or findings (e.g. of endocrine, urinary, neurological or cardiovascular findings); may include testosterone and/or prolactin determination. Prostate examination should be routine. Treatment: Should be tailored to meet patient need/preferences. Partners should be encouraged to participate in such discussions. Comprehensive advice should be given on the chosen treatment, including management of any complications, e.g. priapism. Androgen therapy: Hypogonadism in men causes testosterone deficiency, diminished libido and impotence. Androgen replacement therapy may help with diminished libido but improvements in symptoms of ED are less reliable. If hypogonadism is secondary to hyperprolactinaemia, bromocriptine may be used as adjuncive treatment to androgen replacement. Prostaglandin E1: Alprostadil (synthetic vasoactive prostaglandin E1) provides an artificial erection by relaxing smooth muscle and restricting venous outflow. Administration: Intracavernosal (injection) or intraurethrally (pellet); require some degree of patient training. Erection occurs within 5-10 minutes of injection, irrespective of sexual desire. Intercavernosal injection provides high rates (80-90%) of patient and partner satisfaction and has few contraindications or interactions. Side effects include penile pain, penile fibrosis and priapism. Transurethral administration (with the aid of an applicator) reduces incidence of priapism; useful for needle-phobic patients. Side effects include transurethral bleeding, penile pain and burning. Phosphodiesterase-5 inhibitors (PDE-5 inhibitors): PDE-5 inhibitors are selective, competitive inhibitors of phosphodiesterase-5, the enzyme responsible for the breakdown of cGMP (cyclic guanosine monophosphate) in various tissues; augment erection rather than initiating it and therefore sexual stimulation is required. Clinical studies to date indicate that all three PDE-5 inhibitors available are effective; absorbed rapidly from the GI tract, metabolised, and eliminated predominently via cytochrome P450 (CYP3A4) in the liver. Each drug has unique pharmacological characteristics based on molecular structure, enzyme inhibition profile and pharmacokinetic properties: Side-effects, drug interactions and contraindications are similar for all 3 drugs. Typical side-effects of PDE5 inhibitors are dose-dependant and include headache, facial flushing, nasal congestion and dyspepsia. Each PDE-5 inhibitor has a distinct selectivity that contributes to its safety profile. Visual disturbances can occur with sildenafil, and back and muscle pain has been infrequently reported with tadalafil. Assessment of cardiac fitness is mandatory before prescribing PDE-5s; avoid in patients using nitrate drugs for angina, including glyceryl trinitrate sprays. Dopamine agonists: Apomorphine (Uprima), placed under the tongue, brings about an erection in about 20 minutes. Again arousal activity is needed to bring about the positive effects. References available on request. Revised: December 2008
6.1
used if partner is pregnant. C Decongestants, appetite suppressants, anticoagulants. A Penile or testicular pain, urethral irritation, swelling of veins, symptomatic hypotension, dizziness, rarely priapism.
NEBIDO
Bayer Schering
5NO Androgen. Testosterone undecanoate 250mg/ml. Soln for inj. in amp. 1 x 4ml, A97.84. S Testosterone replacement therapy for male hypogonadism. P 1000mg inj. IM very slowly every 10-14 weeks. Inject deeply into gluteal muscle and avoid intravasal inj. Measure serum testosterone levels before and during treatment. 1st inj. interval may be reduced to min. 6 weeks. Q Under 18 years, not recommended. D Androgen-dependent carcinoma of prostate or of male mammary gland, past or present liver tumours. Use in women. B Exclude risk of pre-existing prostatic cancer. Monitor prostate gland and breast at least once yearly and twice yearly in elderly or at risk patients. Check Hb, hematocrit, and liver function periodically. Caution: Cancer patients at risk of hypercalcaemia, cardiac/hepatic/renal insufficiency, ischemic heart disease, epilepsy, migraine. Patients over 65 years. C Caution: Oral anti-coagulants, ACTH or corticosteroids. A Inj. site pain or SC hematoma, diarrhea, leg pain, arthralgia, dizziness, increased sweating, headache, respiratory disorder, breast pain, gynecomastia, skin disorder, testicular pain, prostate disorder.
PREGNYL
Schering-Plough
6NO Gonadotrophin. Human chorionic gonadotrophin 5000 IU. Powder and solvent for soln. for inj. 1, A3.91. S Cryptorchidism, preoperative preparation of ectopic testes, delayed pubertal growth, hypogonadotrophic hypogonadism in males (stimulus for descent of testes). P Hypogonadotropic hypogonadism: 10002000 IU 2-3 times weekly. Sterility in selected cases of deficient spermatogenesis: 1000-2000 IU 2-3 times per week in combination with HMG for at least 3 months. Once achieved, spermatogenesis may be maintained with hCG alone. Preoperative preparation for ectopic testes: 500 IU 2 or 3 times a week for 1 to 2 months before operation. All by IM or SC inj. Q Delayed puberty associated with hypogonadotropism: 1500 IU twice weekly for at least 6 months. Cryptorchism, not due to anatomic obstruction: Under 6 years: 500-1000 IU twice weekly for 6 weeks. Over 6 years: 1500 IU twice weekly for 6 weeks. Repeat if necessary. D Known or suspected androgendependent tumours in male. B Asthma, migraine, epilepsy, cardiac/renal dysfunction. Allergic diathesis. A Precocious puberty in children (discontinue). Growth spurt (particularly if epiphyseal growth potentially active). Fluid retention.
PUREGON
Schering-Plough
2NO Gonadotropin. Recombinant FSH 50 IU, 100 IU,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
167
6.1 HYPOGONADISM,
ERECTILE DYSFUNCTION, OTHER SEXUAL DISORDERS
150 IU, 300 IU, 600 IU, 900 IU FSH activity. Soln for inj. in vials 0.5ml (50 IU-150 IU), or cartridges 0.36ml (300 IU), 0.72ml (600 IU), 1.08ml (900 IU). 50 IU-1, A26.55; 100 IU-1, A53.10; 150 IU-1, A79.65; 300 IU-1, A159.30; 600 IU-1, A318.60; 900 IU-1, A477.90. S Deficient spermatogenesis due to hypogonadotrophic hypogonadism. P 450 IU/week, preferably in 3 dosages of 150 IU, concomitantly with hCG, for at least 3 to 4 months. 18 months or longer may be necessary. All by SC inj. (cartridges and vials) or SM inj. (vials). Q Not applicable. D Tumours of pituitary, hypothalamus, testis. Primary testicular failure. B Exclude uncontrolled non-gonadal endocrinopathies. Analyse semen 4 to 6 months after beginning of treatment. A Inj. site reactions.
RESTANDOL TESTOCAPS
ScheringPlough
5NO Androgen. Testosterone (undecanoate) 40mg. Soft, oval, orange, transparent, glossy cap. with yellow oily fill marked Org DV3. 60, A18.31. S Male hypogonadism and osteoporosis due to androgen deficiency. P Prepubertal and adult males: Initially 3-4 daily for two to three weeks with morning and evening meal, adjusting to 1-3 daily. Q Not applicable. D Prostatic or breast cacinoma. Hypercalciuria, hypercalcaemia, nephrosis. IHD, untreated HF. B Cardiac, renal or hepatic impairment. Epilepsy, migraine, hypertension. C Caution: Barbiturates and phenylbutazone. A Oedema, premature closure of epiphyses, priapism, decreased fertility.
TESTIM
Ferring
5NO Androgen. Testosterone 50mg. Gel. 30 x 5g, A42.35. S Testosterone replacement therapy for male hypogonadism. P Initially 50mg (1 tube), daily to clean dry skin on shoulders and/or upper arms. Measure early morning serum testosterone approx. 7-14 days after initiation of therapy; if below normal range, increase to 100mg daily (max. dose). Q Not applicable. D Carcinoma of breast or prostate. Use in women. B Not for male infertility or sexual dysfunction/ impotence without demonstrated testosterone deficiency. Exclude risk of pre-existing prostate cancer. Monitor breast and prostate gland at least once yearly and twice yearly in elderly and at risk patients. Inform patient about risk of testosterone transfer with close skin contact; pregnant women must avoid contact with application sites. Skeletal metastases (monitor Ca++), hypertension, ischaemic heart disease, severe cardiac, hepatic or renal insufficiency, epilepsy, migraine. Increased risk of sleep apnoea. May cause improved insulin sensitivity. Check full blood count, lipid profile and liver function tests periodically. May accelerate progression of subclinical prostate cancer and BPH. Irritability, nervousness, weight gain, prolonged or frequent
168
erections may indicate excessive androgen exposure requiring dosage adjustment. Contains propylene glycol. C Caution: Anti-coagulants, ACTH, corticosteroids, propranolol. A Worsened hypertension, headache, acne, appl. site reaction (incl. erythema, rash, pruritus). Increased: PSA, haematocrit, Hb, red blood cell count.
TESTOGEL
Bayer Schering
5NO Androgen. Testosterone 50mg/5g. Gel. 30 x 5g, A41.17. S Testosterone replacement therapy for male hypogonadism. P 5g applied once daily. Q Under 18 years, not recommended. D Prostatic or breast carcinoma. Use in women. B Examine prostate and breast at least annually, or twice yearly in elderly/at risk patients. Not a treatment for male sterility or impotence. Cancer patients at risk of hypercalcaemia. Severe cardiac, hepatic or renal insufficiency; ischaemic heart disease, hypertension, epilepsy, migraine. Perform regular tests for testosterone, Hb, haematocrit and liver function. Increased risk of sleep apnoea. Improved insulin sensitivity may occur. C Oral anticoagulants, ACTH, corticosteroids. A Reaction at application site, erythema, acne, dry skin. Changes in lab. tests, headache, prostatic disorders, gynaecomastia, mastodynia, dizziness, paresthesia, amnesia, hyperaesthesia, mood disorders, hypertension, diarrhoea, alopecia. Reactions to oral or injectable testosterone include prostatic changes and progression of sub-clinical prostatic cancer, urinary obstruction, pruritus, arterial vasodilation, nausea, cholestatic jaundice, changes in liver function tests, increased libido, depression, nervousness, myalgia. During high dose prolonged treatment, electrolyte changes, oligospermia, priapism.
HORMONES
testosterone transfer with close skin contact. Pregnant women should avoid skin contact with application sites. Contains butylhydroxytoluene and propylene glycol. C Caution: Anti-coagulants, ACTH, corticosteroids. A Application site reaction, peripheral oedema, hypertension, gynaecomastia. Increased: PSA, haematocrit, haemoglobin, male pattern baldness.
VIAGRA
Pfizer
2NO
Phosphodiesterase type 5 inhibitor. Sildenafil citrate 25mg, 50mg, 100mg. Blue film-ctd diamond-shaped tabs. marked PFIZER one side and coded VGR 25, VGR 50 or VGR 100 on reverse. 25mg-4, A20.93; 50mg-4, A24.40; 100mg-4, A29.64. S Erectile dysfunction. P Males: 50mg taken 1 hour before sexual activity. The dosage may be increased to 100mg or decreased to 25mg. Max. 100mg. R First dose of 25mg should be used, increasing to 50mg and 100mg. Q Under 18 years, not recommended. D Severe hepatic impairment, hypotension, recent history of stroke or MI, hereditary degenerative retinal disorders. Coadministration with nitric acid donors (e.g. amyl nitrite) or nitrates in any form. Men for whom sexual activity is inadvisable (e.g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure). B Medical history/physical examination should be under taken to diagnose erectile dysfunction. Patients with anatomical deformation of penis (anguation, cavernosal fibrosis, Peyronieâ&#x20AC;&#x2122;s disease) or patients predisposed to priapism, sickle cell anaemia, multiple myeloma or leukaemia. Not indicated for women.Contains lactose. C CYP3A4 inhibitors (cimetidine, ketoconazole, erythromycin, ritonavir, saquinavir, grapefruit juice), alpha-blockers (not within 4 hours). Other treatments for erectile dysfunction, not recommended (no data). TOSTRAN Clonmel A Headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision. Serious 5NO cardiovascular events. Rarely priapism. Androgen. Testosterone 20mg/g. Gel in metered dose canister. 60g, A36.30. VIRIDAL DUO UCB S Testosterone replacement therapy for 2NO male hypogonadism. Prostaglandin. Alprostadil 10, 20, 40mcg. Powder P Initially 3g of gel applied once daily to plus diluent in dual chamber cartridges, needles. abdomen or both inner thighs, at the same time in the morning. Dose titration should be based on Starter packs (with applicator): 10mcg-2, A35.24 (hospital only). 20mcg-2, A42.97 (hospital only). serum testosterone levels and the existence of 40mcg-2, A50.05, (hospital only). Continuation clinical signs and symptoms of androgen packs (without applicator): 10mcg-2, A21.51. deficiency. Daily range: 2-4g of gel. 20mcg-2, A25.84. 40mcg-2, A35.28. Applicator Q Not applicable. D Carcinoma of breast or prostate. Use in (free of charge from Schwarz). S Treatment and diagnosis of erectile women. dysfunction. B Not indicated for male infertility or sexual dysfunction/impotence. Exclude risk of pre- P See SPC. existing prostate cancer. Progression of sub-clinical Q Not applicable. D Sickle cell disease, leukaemia, multiple prostatic cancer and benign prostatic hyperplasia may be accelerated. Caution in patients with renal myeloma, anatomical deformation of the penis (e.g. cavernosal fibrosis, Peyronieâ&#x20AC;&#x2122;s disease). Penis or hepatic impairment, skeletal metastases implants. Men for whom sexual activity is (monitor Ca++), hypertension, ischaemic heart disease, epilepsy, migraine. Increased risk of sleep contraindicated. apnoea. Perform full blood count, lipid profile and B Caution: Coronary heart disease, CHF, liver function tests periodically. May cause pulmonary disease, history of transient ischaemic improved insulin sensitivity. Dose adjustment may attacks, blood clotting disorders. Advise patients be required if symptoms of excessive androgen to seek medical attention if erection persists q4 exposure occur. Inform patients about the risk of hrs. Evaluate risk-benefit: Pre-existing scarring,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES
CORTICOIDS 6.2
3ml, A7.73. S Peri and intra-articular joint conditions: swelling and stiffness associated with RA, OA, bursitis, epicondylitis, tenosynovitis, tendonitis. Intra-lesional: localised lichen planus, alopecia areata, discoid lupus erythematosus. Intramuscular: RA, bronchial asthma, severe seasonal and perennial allergic rhinitis, systemic lupus erythematosus, drug hypersensitivity reactions, ulcerative colitis and Crohn’s disease. BETNELAN UCB P Intra-articular: 10-80mg depending on 6.2 CORTICOIDS joint size and severity of condition. Periarticular: 40NO 30mg. Intralesional: 20-60mg. See SPC. ADCORTYL BMS Glucocorticoid. Betamethasone 0.5mg. White (Intramuscular: Allergic conditions see Section scored tab. marked with tab. name and EVANS. 4NO 14.1) 100, A4.22. Q Dose depends on condition and to a Glucocorticoid. Triamcinolone (acetonide) 10mg/ S Severe asthma, allergic conditions, hay lesser extent body weight and patient age. ml. Aqueous susp. 1ml and 5ml vials. 5 x 1ml, fever, RA, collagen diseases. A5.94; 1 x 5ml, A4.81. 4NO P 0.5mg-5mg daily, reduce maintenance ALSO DEPO-MEDRONE WITH LIDOCAINE PERI/ S Intra-articular joint pain, swelling and to min. effective dose. INTRA ARTICULAR Methylprednisolone (acetate) stiffness associated with rheumatoid arthritis (RA) Q Under 1 year, not recommended; 1-7 40mg, lidocaine (HCl) 10mg/ml. Susp. for inj. in and osteoarthrosis. Bursitis, epicondylitis, years, t-v adult dose; 7-12 years, v-x adult dose. vials. 10 x 1ml, A29.36; 1 x 2ml, A5.33. tenosynovitis. Intradermal lichen simplex chronicus, D See SPC. S Local use in inflammatory or rheumatic granuloma annulare, lichen planus, keloid, conditions. BETNESOL UCB alopecia areata, hypertrophic scars. P Intra articular: 10-80mg depending P Intra-articular: 2.5-15mg depending on 0NO upon joint size and severity of condition. severity of condition and joint size. Intradermal: 2- Glucocorticoid. Betamethasone Na+ phos. 0.5mg. Periarticular: 4-30mg. See SPC. 3mg depending on size of lesion. Max. 5mg in Pink scored tab. marked with tab. name and Q Dose depends on condition and to a one site. EVANS. 100, A3.71. lesser extent body weight and patient age. Q Under 6 years, not recommended. Older S Severe asthma, allergic conditions, RA, D See SPC. Do not give via intrathecal or children, adjust dose suitably. collagen diseases. IV routes. Do not inject into achilles tendon. D Active peptic ulcer (or history). Active/ P 0.5mg-5mg daily in water; reduce B Elderly, children, diabetes, chronic latent/healed tuberculosis; viral infection, systemic maintenance to min. effective dose. psychoses, CHF, renal insufficiency, glaucoma, fungal infections or active bacterial infections not Q Under 1 year, not recommended; 1-7 osteoporosis. See SPC. controlled by antibiotics. Acute psychoses. Admin. years, t-v adult dose; 7-12 years, v-x adult dose. C Cyclosporin, warfarin, salicylates. by IV, intrathecal or intraocular inj. D See SPC. A Hypersensitivity, GI disorders, elevated B Recent intestinal anastomoses, function tests, anti-inflammatory and thrombophlebitis, psychotic tendencies, DELTACORTRIL ENTERIC Phoenix liver immunosuppressive effects, musculoskeletal exanthematous disease, chronic nephritis, 0NO effects, fluid and electrolyte disturbances, skin metastatic carcinoma, osteoporosis, acute Glucocorticoid. Prednisolone 2.5mg, 5mg. Brown disorders, endocrine and metabolic disorders, glomerulonephritis, hypertension, CHF, glaucoma and maroon ent-ctd tabs. 2.5mg-30, A2.01; 2.5mg- neuropsychiatric disorders, ophthalmic disorders, (or history), previous steroid myopathy, epilepsy, 100, A5.40; 5mg-30, A3.54; 5mg-100, A9.90. leucocytosis, thromboembolism, malaise, liver failure, diabetes, hypothyroidism, cirrhosis. S Conditions requiring systemic withdrawal symptoms. Menstrual irregularities may occur. Anaphylactoid corticosteroid therapy. See SPC. reactions have occurred rarely. Prolonged therapy: V 5-60mg daily, see SPC. Maintenance: FLORINEF BMS Particularly in children; withdraw gradually. Risk Reduce to min. effective dose. 0NO of increased susceptibility to infections and their D Untreated systemic infections, ocular Mineralocorticoid. Fludrocortisone (acetate) 0.1mg. severity. Contains benzyl alcohol. Intra-turbinal, herpes simplex, Cushing’s disease. Pink scored tab. marked SQUIBB and coded 429. subconjunctival, sub-tenons, retrobulbar and B Caution with:Tuberculosis, hypertension, 56, A3.13; 100, A10.80. intraocular inj.; no adequate safety data. IntraCHF, liver failure, renal insufficiency, family history S Replacement therapy in Addison’s articular Inj.: Avoid over-use of joints in which of diabetes, osteoporosis, history of severe disease. Treatment of salt losing adrenogenital symptomatic benefit has been obtained; if inj. is affective disorders or steroid-induced psychoses, syndrome. given into tendon sheaths, avoid inj. into tendon epilepsy, hypothyroidism, cirrhosis, peptic P Addison’s disease: 0.05-0.3mg daily. itself; avoid repeated inj. into inflamed tendons. ulceration, previous steroid myopathy, Adrenal hyperplasia: 1-2mg daily. Restrictions of Do not inj. achilles tendon. Pregnancy, lactation; thromboembolic disorders, patients with Na+ intake and K+ suppl. may be required. not recommended. See SPC. myasthenia gravis receiving anticholinesterase Q Adjust adult dose according to age, C Amphotericin B inj., K+ depleting therapy; elderly, children. Risk of adrenocortical weight and severity. agents, anticholinesterases, oral anticoagulants, insufficiency. Avoid exposure to chickenpox, D Peptic ulcer, active TB, acute psychosis, antidiabetics, antihypertensives incl. diuretics, anti- herpes zoster, measles. Pregnancy, lactation (only bacterial/viral infections. Pregnancy (only if if benefit outweighs risk). essential). C Live vaccines (wait 3 months). Caution: B Adrenal cortical atrophy-develops with CYP3A4 inducers/inhibitors, antidiabetic drugs, prolonged therapy. Withdraw gradually. Chicken NSAIDs, rifamycins, erythromycin, anticoagulants, pox, shingles, measles. Diverticulitis, recent amphotericin, ritonavir, cardiac glycosides, intestinal anastomoses, thrombophlebitis, severe ciclosporin, methotrexate, mifepristone, affective disorders (or history of), renal oestrogens, somatropin, sympathomimetics, insufficiency, chronic nephritis, exanthematous antihypertensives, diuretics. disease, metastatic carcinoma, osteoporosis, A See SPC. myasthenia gravis, latent or healed TB, systemic nodules of the cavernous body, pre-existing penile deviation, clinically relevant phimosis. Increased risk of penile scarring if excessive use. C Not recommended: a-adrenergic blocking agents, papaverine. Caution: MAOIs with a-adrenergic drugs, BP lowering and vasodilating drugs. A Burning sensation during and after inj., sensation of tension in the penis, pain at inj. site, fibrotic alterations.
tubercular drugs, cyclosporin, digitalis glycosides, oestrogens, hepatic enzyme inducers, human growth hormone, ketoconazole, nondepolarising muscle relaxants, NSAIDs, thyroid drugs, vaccines. A Fluid and electrolyte disturbances, increased susceptibility and severity of infections. Hypersensitivity reactions. GI, musculoskeletal, skin, eye, endocrine and neurological disorders. See SPC.
Anti-Doping Information d This medicine is permitted but should DEPO-MEDRONE Pharmacia be declared on the 4NO Doping Control Form Glucocorticoid (Prohibited in Competition when by intra-muscular route see Section 14.1). at the time of testing. given Methylprednisolone (acetate) 40mg/ml. Susp. for inj. in vials. 1 x 1ml, A2.97; 1 x 2ml, A5.33; 1 x
fungal infections, hypertension, CHF, glaucoma, previous steroid myopathy, epilepsy, hypo/ hyperthyroidism, cirrhosis, diabetes. Menstrual irregularities may occur. Anaphylactoid reactions have occured rarely. Children, elderly. C Amphoteracin B inj. And K+ depleting agents. Anticholinesterases, oral anticoagulants,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
169
6.3 GROWTH
HORMONES
FAILURE AND ACROMEGALY
tuberculosis; in acute glomerulonephritis. Hypertension; glaucoma (or history), previous steroid myopathy or epilepsy, diabetes, hypothyroidism, cirrhosis. Do not carry out intraarticular inj. in the presence of active infection in or near joints. Intra-turbinal, subconjunctival, subtenons, retrobulbar and intraocular inj.; no adequate safety data. Anaphylactoid reactions reported rarely. Withdraw gradually. Contains benzyl alcohol. Prolonged use; particularly in children. Intra-articular inj.: Avoid over-use of joints in which symptomatic benefit has been HYDROCORTONE MSD obtained; avoid inj. into the tendon itself if inj. are given into tendon sheaths; avoid repeated inj. 0NO into inflamed tendons. Do not inj. into achilles Glucocorticoid-mineralocorticoid. Hydrocortisone tendon. IM inj.: During prolonged therapy a 10mg. White quarter scored tab. coded MSD 619. liberal protein intake is essential. Pregnancy (only 30, A0.80. if essential), lactation. See SPC. S Replacement therapy in primary, C Amphotericin B inj. and K+ depleting secondary or acute adrenocortical insufficiency. agents, anticholinesterases, oral anticoagulants, Pre-operatively, and during serious trauma or illness in patients with known adrenal insufficiency antidiabetics, antihypertensives incl. diuretics, antitubercular drugs, cyclosporin, digitalis glycosides, or doubtful adrenocortical reserve. oestrogens, hepatic enzyme inducers, human P 20-30mg daily, sometimes with 4-6g growth hormone, ketonconazole, nondepolarising NaCl or 50-300mcg fludrocortisone daily. muscle relaxants, NSAIDs, thyroid drugs, vaccines. Q 0.4-0.8mg/kg daily in 2 or 3 divided A Fluid and electrolyte disturbances. doses. Hypersensitivity reactions. GI, musculoskeletal, skin, D Systemic fungal infections. Lactation. eye, endocrine and neurological disorders. See B Non-specific UC, abscess, diverticulitis, SPC. fresh intestinal anastomoses, peptic ulcer, renal insufficiency, hypertension, diabetes, CHF, recent PREDNESOL Phoenix MI, previous steroid myopathy, glaucoma, 0NO osteoporosis, myasthenia gravis, cerebral malaria, Glucocorticoid. Prednisolone (disodium phos.) hypothyroidism, cirrosis, latent amoebiasis, 5mg. Soluble pink scored tab. marked PRED SOV. strongyloidiasis, ocular herpes simplex. Growth 20, A6.67. retardation. Pregnancy. Driving/using machines. S Allergic, rheumatic and inflammatory C Live virus vaccines (contra). Caution: conditions. Phenytoin, ephedrine, rifabutin, carbamazepine, P Initially 10-100mg in water daily in aminoglutethimide, barbiturates, rifampicin, divided doses reducing to min. effective dose. See ketoconazole, coumarin anticoagulants, K+depleting diuretics, acetylsalicylic acid. SPC. A Hypersensitivity, leucocytosis, thromboQ Under 1 year, not recommended; 1-7 embolism, weight gain, increased appetite, years, t-v adult dose; 7-12 years, v-x adult dose. nausea, elevation of BP, salt and water retention, D See SPC. posterior subcapsular cataracts, glaucoma, vertigo, SOLU-CORTEF Pharmacia convulsions, headache, psychic disturbances, thin fragile skin, impaired healing, skin reactions, 0NO endocrine disorders, GI disorders, muskuloskelal Glucocorticoid-mineralocorticoid. Hydrocortisone effects. (sodium succinate) 100mg. Rubber capped vial with white to off white powder and water for KENALOG BMS injections. 10 x 100mg without diluent, A5.24. 4NO S Conditions where rapid corticosteroid Glucocorticoid (Prohibited in Competition when effect is required. given by intra-muscular route see Section 14.1). P 100-500mg by slow IV inj. over 1-10 Triamcinolone (acetonide) 40mg/ml. Pre-filled mins. Repeat 2 to 6 hourly as necessary. syringe. 1ml, A2.46; 2ml, A4.26. Q Dose may be reduced according to S Intra-articular: Joint inflammation such severity of condition and response but should not as seen with RA, OA, psoriatic arthropathy, bursae fall below 25mg daily. and tendons. Intramuscular: Corticosteroid D Systemic infections. Lactation. responsive conditions incl. allergic asthma, RA, B Withdraw therapy gradually. Salt and/or certain connective tissue disorders, where depot mineralocorticoid admin. concurrently. May mask therapy is indicated. signs of infections. Monitor: Use of corticosteroids P Intra-articular: 5-10mg for smaller joints; in TB. Avoid IM inj. in deltoid area. Caution: up to 40mg for larger joints depending on specific Osteoporosis, hypertension, CHF, severe affective disease being treate. (Intramuscular: Allergic disorders, diabetes mellitus, glaucoma, cirrhosis, conditions see Section 14.1). renal insufficiency, epilepsy, peptic ulceration. UC, D Systemic infections unless specific antidiverticulitis, myasthenia gravis, hypothyroidism, infective therapy is employed. Admin. by IV, Cushingâ&#x20AC;&#x2122;s syndrome. Children: Keep treatment to intrathecal or intraocular inj. min. Elderly. B Risk of increased susceptibility to C Cyclosporin, CYP450 inhibitors/inducers, infections and their severity. Recent intestinal anticholinesterases, hypoglycaemic agents, antianastomoses, thrombophlebitis, psychotic hypertensives, diuretics, acetazolamide, loop tendencies, exanthematous disease, chronic diuretics, thiazide diuretics, carbenoxolone. nephritis, metastatic carcinoma, osteoporosis, Anticoagulants, salicylates, neuromuscular active peptic ulcer (or history); latent or healed blockers. antidiabetics, antihypertensives and diuretics, Isoniazid, cyclosporin, Digitalis glycosides, oestrogens, CYP450 inducers, ketokonazole, nondepolarising muscle relaxants, NSAIDs, vaccines. A Electrolyte disturbance, mineral metabolism, glucose metabolism and gluconeogenesis, nitrogen depletion, diminished lymphoid tissue and immune response, inhibition of pituitary function, Cushingoid Syndrome, increase in blood coagulability, diminished inflammatory response.
170
A Anaphylactic reactions, GI disturbances, steroid myopathy, muscle weakness. Na+ and water retention, K+ loss, hypertension. Impaired healing, petechiae, skin atrophy, thinning skin. Growth suppression, menstrual irregularity, weight gain, impaired glucose levels, increased appetite. Euphoria, psychological dependence, mood swings, depression, insomnia, psychosis, schizophrenia, seizures.
SOLU-MEDRONE
Pharmacia
0NO Glucocorticoid. Methylprednisolone (sodium succinate) 40mg, 125mg, 500mg, 1g. Powder in vials, plus solvent. 40mg (1ml solvent), A1.51. 125mg (2ml solvent), A4.53; 500mg (rcv plus solvent), A10.83; 1g (rcv plus solvent), A19.52. S Acute adrenal insufficiency. Hypersensitivity reactions. Suppression of graft rejection. Cerebral oedema. Prevention of nausea and vomiting associated with cancer chemotherapy. P 0.5-30mg/kg daily IM or slow IV inf. over at least 30 mins. See SPC. Q See lit.. D See SPC.
6.3 GROWTH FAILURE AND ACROMEGALY
GENOTROPIN
Pfizer
5NT Recombinant human growth hormone. Somatropin 5.3mg, 12mg. Powder and solvent for soln. for inj. Two chamber cartridge, other chamber contains 1ml WFI with 0.3% m-cresol preservative. 5.3mg A166.49; 12mg A374.59. For use in Genotropin pen, Genotropin mixer or Genotropin Zip-Tip Needle-Free Device. Pens, mixers, Zip-Tip devices, needles and nurse service provided free of charge by Pfizer. Freephone 1800 460900. S Children: Growth disturbance due to insufficient secretion of growth hormone (GH) or associated with Turner syndrome or chronic renal insufficiency. Growth disturbance in short children born small for gestational age (SGA) who failed to show catch-up growth by 4 years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. Adults: Replacement therapy in pronounced GH deficiency.
5NT ALSO GENOTROPIN 5.3MG CARTRIDGE Somatropin (human growth hormone). 1, A166.49. For use in Genotropin Pen, Genotropin Mixer or Genotropin Zip-Tip Needle-Free device.
5NT ALSO GENOTROPIN 12MG CARTRIDGE Somatropin (human growth hormone). 1, A374.59. For use in Genotropin Pen, Genotropin Mixer or Genotropin Zip-Tip Needle-Free device.
5NT ALSO GENOTROPIN MINIQUICK Somatropin. Powder and solvent for soln. for inj. Two chamber syringe. Other chamber contains 0.25ml WFI. Preservative-free single use device, room temp. storage by patient. 0.2mg-7, A47.17; 0.4mg-7, A94.37; 0.6mg-7, A141.54; 0.8mg-7, A188.72; 1mg-7, A235.90; 1.2mg-7, A283.08; 1.4mg-7, A330.26; 1.6mg-7, A377.44; 1.8mg-7, A424.63; 2.0mg-7, A471.81. P Initially, 0.15-0.3mg per day. Increase gradually as determined by IGF-I concentration.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES Seldom exceeds 1mg daily. Q Admin. by SC inj. Dosage is individual. GH deficiency: 0.025-0.035mg/kg body weight per day (0.7-1mg/m2 body surface per day). Turner’s syndrome/chronic renal insufficiency: 0.0450.05mg/kg per day (1.4mg/m2). PWS/SGA: 0.035mg/ kg daily (1mg/m2); PWS, max. 2.7mg daily. D Active tumour. Closed epiphyses in children treated for growth failure. Acute critical illness. Pregnancy. B Test thyroid function after starting treatment. Monitor for evidence of glucose intolerance. Diabetes mellitus. In SGA children, measure fasting insulin, blood glucose, IGF-I level and avoid starting treatment near onset of puberty. Monitor for respiratory infections. Monitor for: Upper airway obstruction, scoliosis, sleep apnoea in patients with PWS. PWS: Ensure effective weight control before and during treatment. Chronic renal insufficiency. Elderly, prolonged treatment. C Caution: Substrates of cytochrome P450. A Adults: Fluid retention, paraesthesia, arthralgia, myalgia, stiffness in the extremities. Children: Transient skin reactions. Both: Formation of antibodies.
GROWTH
FAILURE AND ACROMEGALY
with NordiPen 5, 10, 15 resp. and NovoFine needles. Inj. device (NordiPen) provided free by Novo Nordisk. S Growth failure due to hormone insufficiency, Turner’s syndrome or chronic renal disease. Replacement therapy in adults with growth hormone insufficiency. P Start with low dose 0.15-3mg/day (equal to 0.45-0.9 IU/day). Increase gradually at monthly intervals based on clinical response and patient experience of adverse events. Maintenance doses vary considerably, seldom exceed 1mg/day (3 IU/ day). Q Growth hormone insufficiency: 2535mcg/kg/day or 0.7-1mg/m2/day, equal to 0.07-0.1 IU/kg/day (2-3 IU/m2/day). Turner’s syndrome/ chronic renal disease, 50mcg/kg/day or 1.4mg/m2/ day equal to 0.14 IU/kg/day (4.3 IU/m2/day). D Tumour, pregnancy and lactation, renal transplantation. B Monitor for development of diabetes, hypothyroidism, slipped capital femoral ephyses, intracranial hypertension. A Oedema, local inj. site reactions.
6.3
secretion: CNS neoplasm. Turner syndrome: Menorrhagia. Growth failure with CRI: Renal failure, peritonitis, osteonecrosis, blood creatinine increase. Adults with GH deficiency: paraesthesia, hyperglycaemia, hyperlipidaemia, insomnia, synovial disorder, arthrosis, muscular weakness, back pain, breast pain, gynaecomastia.
PARLODEL
Meda
2MO Dopamine agonist. Bromocriptine (mesylate) 2.5mg. White tab. angle scored and marked XC one side Sandoz on reverse. 30, A6.44; 100, A21.47.
2MO
ALSO PARLODEL CAPSULES Bromocriptine (mesylate) 5mg. Blue/white cap. marked P5. 100, A41.84. S Adjunct in acromegaly. Prolactinomas. P Initially: 1.25mg at bedtime. Titrate gradually at 2 to 3 day intervals to 5mg six hourly with meals. Q Not applicable. D Toxaemia of pregnancy, puerperal postpartum hypertension, coronary disease. NUTROPINAQ Ipsen Hypersensitivity to ergot alkaloids. 5NT B Usage requies regular surveillance. INCRELEX Ipsen Recombinant human growth hormone. History of peptic ulceration, psychotic or severe 5NT Somatropin 10mg (30 IU). Clear, colourless, sterile cardiovascular disorders. Perform regular sln for inj. 2ml cartridge pack-1, A355.19. Recombinant IGF-1. Mecasermin 40mg. Aqueous, gynaecological assessment for women receiving clear and colourless sln for inj. 10mg/m, A704.78. S Children: Long-term treatment of prolonged therapy. Observe patients on long-term growth failure due to inadequate endogenous S Long-term treatment of growth failure doses for manifestations of retroperitoneal growth hormone (GH) secretion; long-term in children and adolescents with severe primary fibrosis. treatment of growth failure associated with IGF-1 deficiency (Primary IGFD). C Alcohol, erythromycin, psychoactive Q Initially 0.04mg/kg twice daily by SC inj., Turner syndrome; treatment of prepubertal agents, drugs effecting BP. children with growth failure associated with shortly before a meal or snack and rotating inj. A Postural hypotension, nausea, vomiting, sites. May be raised in increments of 0.04mg/kg to chronic renal insufficiency (CRI) up to the time of mild constipation, dry mouth, leg cramps, renal transplantation. Adults: Replacement therapy hypertension, MI, stroke, drowsiness, confusion, max 0.12mg/kg twice daily. D IV admin. Active or suspected neoplasia in confirmed GH deficiency of either childhood or hallucinations, headache, dizziness, seizures, adult-onset etiology. (discontinue if develops). Premature babies or episodes of reversible pallor of fingers and toes P Admin. by 1 daily SC injection rotating neonates. Pregnancy, lactation. induced by cold, psychomotor exitation, B Not a substitute for GH treatment. Not injection site. Initially 0.15-0.3mg/day. Adjust dose dyskinesia, retroperitoneal fibrosis. to be used for growth promotion in patients with gradually as determined by serum IGF-1 concentration. Seldom exceeds 1mg/day. Admin. SAIZEN Merck Serono closed epiphyses. Correct thyroid and nutritional deficiencies before treatment. Caution: History of lowest efficacious dose. In older or overweight 5NT hypoglycaemia, inconsistent food intake; glucagon patients, lower doses may be necessary. Growth hormone. Somatropin 1.33mg, 3.33mg, Q Admin. by 1 daily SC injection rotating inj. may be required if a person with severe 8mg. Powder in vials plus diluent. 1.33mg-1, hypoglycaemia is uncounscious or unable to ingest injection site. Children with inadequate GH A41.11; 3.33mg-1, A102.79; 8mg Click.easy-1, secretion: 0.025-0.035mg/kg bodyweight food normally, doses of insulin and/or other A265.87. One.click (automatic injector) and daily.Turner syndrome: Up to 0.05mg/kg hypoglycaemic agents may need to be reduced. Cool.click (needle free) devices free from company. bodyweight daily. Growth failure with CRI: Up to May have insulin-like hypoglycaemic effects; S Growth failure in children due to 0.05mg/kg bodyweight daily. admin shortly before or after a meal or snack. deficiency of endogenous growth hormone. D Closed epiphyses. Active neoplasm. Echocardiogram recommended before initiation, Turner syndrome. Growth failure in prepubertal Discontinue if evidence of tumour growth after treatment and regularly in case of abnormal children due to chronic renal failure. Replacement develops. Acute critical illness due to complications echocardiogram findings. May occur: Lymphoid therapy in adults with pronounced growth following open-heart or abdominal surgery, tissue hypertrophy associated with complications, hormone deficiency as diagnosed by a single intracranial hypertension with papilloedema, visual multiple accidental traumas or to treat patients dynamic test. having acute respiratory failure. Pregnancy. changes, headache, nausea and/or vomiting, P Growth hormone defeciency, low doses B In adults with GH deficiency, confirm slipped capital femoral epiphysis and progression of 0.15-0.3mg daily by SC inj. Max. 1mg daily. diagnosis depending on etiology. Previous of scoliosis in patients who experience rapid Q Growth hormone deficiency, 0.025malignant disease, history or intracranial lesion. growth, local or systemic allergic reactions. 0.035mg/kg body weight daily by SC inj. Turner Not indicated for children with growth failure due Reconsider treatment if patient remains nonsyndrome, 0.045-0.05mg/kg daily by SC inj. Renal to Prader-Will syndrome unless GH deficiency responsive after a year. Contains benzyl alcohol. failure, 0.045-0.05mg/kg daily by SC inj. diagnosed. Monitor: Evidence of glucose A Thymus hypertrophy, headache, D Epiphyseal fusion, tumour. Pregnancy, intolerance, progression of renal osteodystrophy hypoacusis, tonsillar hypertrophy, snoring, lactation. (growth failure secondary to CRI), signs of scoliosis hypoglycaemia, injection site hypertrophy. See B Intracranial lesion, intracranial (children). Intracranial hypertension may occur. SPC. hypertension, diabetes, ACTH deficiency. Monitor Monitor thyroid function. Terminate treatment thyroid function. following renal transplantation. Lactation. NORDITROPIN SimpleXx A Hypothyroidism, oedema, pain at inj. C Caution: Substrates of CYP450. Novo Nordisk site, lipoatrophy. A All indications: Antibody building, 5NT hypothyroidism, impaired glucose tolerance, SANDOSTATIN Novartis headache, hypertonia, arthralgia, myalgia, Human growth hormone. Somatropin. Premixed 2NT oedema, peripheral oedema, injection site sln. Cartridges: 5mg/1.5ml, A242.09; 10mg/1.5ml, A485.05; 15mg/1.5ml, A533.54. Cartridge for use reactions, asthenia. Children with inadequate GH Somatostatin analogue. Octreotide (acetate) 50, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
171
6.4 DIABETES
HORMONES
MELLITUS
control despite dual oral therapy. 4) In combination with insulin in patients with insufficient glycaemic control on insulin for whom metformin is inappropriate. P Initially, 15-30mg once daily; may be increased in increments up to 45mg once daily. In combination with insulin, current insulin dose can 2NT be continued. If hypoglycaemia occurs, decrease ALSO SANDOSTATIN LAR Octreotide (acetate) insulin dose. 10mg, 20mg, 30mg. Microspheres for susp. 4Q Under 18 years, not recommended. weekly depot inj. 10mg-1, A899.00; 20mgD Cardiac failure (or history of) NYHA 1,A1198.66; 30mg-1, A1498.33. stages I to IV, hepatic impairment, diabetic S Treatment of acromegaly in patients ketoacidosis. Pregnancy, lactation. controlled by subcutaneous Sandostatin in whom B Can cause fluid retention; monitor for surgery, dopamine agonists or radiotherapy are HF and discontinue if deterioration in cardiac ineffective or inappropriate, or in interim period status. Caution, over 75 years. Monitor weight until radiotherapy becomes effective. gain. Check liver enzymes prior to initiation and P When control established, initially 20mg periodically thereafter; do not initiate if ALT q by deep intragluteal inj. every 4-weeks for 3 2.5xULN and discontinue if ALT remains q 3xULN months. Admin. by deep intragluteal inj. only. or if jaundice occurs. Long term use: Consider risk Adjust subsequent doses according to levels of GH of fractures. or IGF-1 and clinical response. C Gemfibrozil, rifampicin. Q Not recommended. A Visual disturbance, upper RTI, weight B Use only under hospital specialist increase, hypoaesthesia. Also with metformin: supervision. Pregnancy, lactation. Diabetics may Anaemia, arthralgia, headache, haematuria, show reduced hypoglycaemic requirements. In erectile dysfunction. With sulphonylurea: long term therapy, monitor thyroid and hepatic ZOMACTON Ferring Flatulence, dizziness, weight gain, increase in function, gall stone development. creatinine phospokinase. With insulin: C Cyclosporin, cimetidine, bromocriptine. 5NT A Inj. site reactions, GI upset, gall stones, Growth hormone. Somatropin (rbe) 4mg. Powder Hypoglycaemia, oedema, bronchitis, back pain, arthralgia, dyspnoea, HF, weight increase. biliary colic. Rarely persistent hyperglycaemia. in vial plus diluent. 1, A102.57. Hepatitic dysfunction. S Growth failure in children due to Novo Nordisk deficiency of endogenous growth hormone. Long- ACTRAPID SOMATULINE AUTOGEL Ipsen term treatment of growth retardation due to 5MO Turnerâ&#x20AC;&#x2122;s syndrome confirmed by chromosome 2NT Fast-acting human soluble insulin. Insulin 100 IU/ analysis. Somatostatin analogue. Lanreotide (acetate) ml. 10ml. 1, A11.03. P Not applicable. 60mg, 90mg, 120mg. Pre-filled syringe. 60mg-1, S Diabetes mellitus. Q GH deficiency: 0.17-0.23mg/kg body A900.48; 90mg-1, A1199.54; 120mg-1, A1548.44. V By SC, IM or IV inj. in accordance with weight per week divided into 6-7 SC inj.; max. S Treatment of acromegaly when the individual requirements. Duration approx. 8 hrs 0.27mg/kg weekly. Turnerâ&#x20AC;&#x2122;s syndrome: 0.33mg/kg level of growth hormone and IGF-l remains following SC inj. abnormal after surgery and/or radiotherapy, or in body weight per week divided into 6-7 SC inj. D Hypoglycaemia. D Epiphyseal fusion, tumour, pregnancy, patients requiring treatment before such lactation. Premature babies, neonates. Acute intervention. AMARYL sanofi-aventis critical illness with complications following P Initially 60-120mg every 28 days adjust 2NO abdominal/ open heart surgery, multiple according to response (as judged by Sulphonylurea. Glimepiride (INN) 1mg, 2mg, 3mg, accidental/ trauma, acute respiratory failure or symptomatology and/or biochemical monitoring). 4mg. Pink, green, light-yellow and light-blue similar. Q Not recommended. oblong tabs. resp. All scored on both sides. 1mgB Intracranial lesion, diabetes, ACTH 2NT A1.64; 2mg-30, A2.86; 3mg-30, A11.85; 4mg30, ALSO SOMATULINE LA Lanreotide 30mg. Powder deficiency. Monitor thyroid function, signs of 30, A4.62. scoliosis. Renal transplantation (discontinue). in vial plus diluent in amp., needles and syringe. S Type II diabetes mellitus. Children Q 3years (contains benzyl alcohol). Single unit dose, A531.96. P 1mg daily increasing at 1-2 week C Caution: Glucocorticoids, androgens, P Initially 30mg by IM inj. every 14 days. oestrogens or anabolic steroids, insulin, cyto P450 intervals to 2mg, 3mg or 4mg daily. Max. 6mg Adjust dose frequency according to response (as daily. Take tabs. before or during first main meal. substrates. judged by symptomatology and/or biochemical Renal impairment, see SPC. A Antibodies formation, transient skin monitoring). Q Not recommended. reactions. Q Not recommended. D Insulin dependent diabetes, diabetic D Pregnancy, lactation. 6.4 DIABETES MELLITUS coma, ketoacidosis, severe renal and liver B Diabetes (monitor blood glucose), risk insufficiency. of gallstones (perform echography of gall bladder ACTOS Takeda B Elderly, endocrine disorders, stress, before therapy, then every 6 months during G6PD-deficiency, Lapp lactase deficiency. 2MO therapy). Thiazolidinedione. Pioglitazone (HCl) 15mg, 30mg; Pregnancy, lactation. Avoid hypoglycaemia while C Cyclosporin A. driving. 45mg. White round tabs. marked 15, 30, or 45 A Pain at inj. site, GI side effects, resp. onone side and ACTOS on reverse. 15mg-28, C Phenylbutazone, azapropazone, gallstones, altered glucose regulation. A39.50; 30mg-28, A58.75; 45mg-28, A60.52. oxyfenbutazone. Insulin and oral antidiabetic products. Salicylates and PA salicylic acid, anabolic S Type 2 diabetes mellitus: 1) as SOMAVERT Pfizer steroids and male sex hormones, chloramphenicol, monotherapy in patients inadequately controlled 2NT certain long acting sulfonamides, tetracyclines, by diet and exercise for whom metformin is Other anterior pituitary lobe hormones and quinolone antibiotics and clarithromycin. inappropriate. 2) As combination therapy in analogues. Pegvisomant 10mg, 15mg, 20mg. Vials patients with insufficient glycaemic control with Coumarin anticoagulants, fenfluramine, fibrates, containing white to slightly off white powder and either metformin or sulphonylurea (with ACE inhibitors, fluoxetine, MAO-inhibitors. solvent for soln. for inj. 10mg-30, A2,647.05; metformin particularly in overweight patients, or Allopurinol, probenecid, sulfinpyrazone, 15mg-30, A3,970.58; 20mg-30, A5,294.11; 20mg-1, with a sulphonylurea only where metformin is sympatholytics. Cyclophosphamide, A176.60. inappropriate). 3) In combination with metformin trophosphamide and iphosphamides. Miconazol, and a sulphonylurea, in patients (particularly S Acromegaly with inadequate response fluconazole, pentoxifylline (high dose parenteral). overweight patients) with insufficient glycaemic to surgery and/or radiation therapy and where Tritoqualine. Oestrogens, progestogens, saluretics, 100, 500mcg per ml. Soln. in vials. 50mcg-5 x 1ml, A20.79; 100mcg-5 x 1ml, A39.12; 500mcg-5 x 1ml, A189.51. S Acromegaly. P 100-200mcg three times daily by SC inj. Q Not recommended.
172
treatment with somatostatin analogues did not normalise IGF-1 concentrations or was not tolerated. P Initially, 80mg loading dose admin. as SC inj., followed by 10mg reconstituted in 1ml of solvent by SC inj. once daily. Adjust dose in 5mg/ day increments based on serum IGF-1 levels . Max. R 30mg/day. Q No experience. B Growth hormone-secreting pituitary tumours. Monitor: Serum IGF-1 concentrations, serum ALT, serum AST. Liver disease, diabetes mellitus. Potential increased female fertility, advise adequate contraception. Pregnancy (unless clearly necessary), lactation. C Insulin, oral hypoglycaemic agents. May affect growth hormone assays. A Headache, dizziness, somnolence, tremor, GI disorders, sweating, pruritis, rash, arthralgia, myalgia, peripheral swelling, hypercholesterolemia, weight gain, hyperglycemia, hunger, hypertension, influenza, fatigue, injection site bruising/bleeding/reaction/hypertrophy, abnormal liver function tests, abnormal dreams, sleep disorder.
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c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES
DIABETES
MELLITUS
6.4
if greater glycaemic control required. Q Under 18 years, not recommended. D Cardiac failure or history of cardiac failure (NYHA class I to IV), Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI), hepatic impairment, raised liver enzymes, diabetic ketoacidosis or diabetic pre-coma. Pregnancy, lactation. AVANDAMET GSK B Ischaemic heart disease and/or peripheral arterial disease (not recommended). 2NO Monitor for fluid retention, other signs of cardiac Thiazolidinedione/biguanide. Rosiglitazone failure (discontinue if any deterioration). Severe (maleate)/metformin (HCl) 1mg/500mg, 2mg/ renal insufficiency. Monitor liver enzymes prior to 500mg, 2mg/1000mg, 4mg/1000mg. Film-ctd tabs. APIDRA sanofi-aventis marked gsk on one side. Yellow, pale pink, yellow initiation and periodically thereafter. Monitor weight gain, Hb levels. 5MO and pink marked 1/500, 2/500, 2/1000 and 4/1000 C Not reommended: Insulin (use only in resp. on reverse. 1mg/500mg-112, A32.10; 2mg/ Rapid acting insulin analogue. Insulin glulisine exceptional cases and under close supervision). 3.49mg/ml (equiv. to 100 U/ml). Clear colourless 500mg-56, A32.99; 112, A65.96; 2mg/1000mg-56, Caution: Gemfibrozil, rifampicin. A35.70; 4mg/1000mg-56, A65.45. soln for inj. Pre-filled pens: Optiset 5 x 3ml, A Hypercholesterolaemia, anaemia A39.00; SoloStar 5 x 3ml, A33.41. Cartridges: 5 x S Type 2 diabetes mellitus patients, particularly overweight patients, unable to achieve (monotherapy). Hypoglycaemia, anaemia, GI 3ml, A39.00. Vial 1 x 10ml, A25.99. sufficient glycaemic control at maximally tolerated disorders (with metformin). Hypoglycaemia, S Diabetes mellitus where insulin is thrombocytopenia, anaemia, hyperlipidaemia , dose of oral metformin alone. required. weight increase, oedema, dizziness (with P Initially, 2mg/1000mg twice a day. May P Admin. shortly (0-15 min) before or be increased to 8mg/day after 8 weeks if required. sulphonylureas). soon after meals by SC inj. in abdominal wall, thigh or deltoid or by continuous SC pump inf. in Max. daily dose: 8mg/2000mg. BYETTA Lilly abdominal wall. Rotate inj. sites . Q Under 18 years, not recommended. 5NO Q Under 6 years, not recommended. 6 D Cardiac failure or history of cardiac years or older, same as adults. Other blood glucose lowering drugs. Synthetic failure (NYHA stages I to IV), Acute Coronary D Hypoglycaemia. exenatide 5mcg/20mcl, 10mcg/40mcl. Soln for inj. Syndrome (ACS, unstable angina, NSTEMI and B Use in regimens incl. intermediate or Prefilled pen. 5mcg-1, A89.06; 10mcg-1, A89.06. STEMI), cardiac or respiratory failure, recent long acting insulin or basal insulin analogue. Dose myocardial infarction, shock, hepatic impairment, S Type 2 diabetes mellitus in combination adjustment may be required: Renal/hepatic with metformin and/or sulphonylureas in patients acute alcohol intoxication, alcoholism, diabetic impairment, elderly, change in insulin brand, ketoacidosis or diabetic pre-coma, renal failure or who have not achieved adequate glycaemic illness, emotional disturbances, change in physical renal dysfunction (ccq135mcmol/l in males and control on max. tolerated doses of these oral activity or diet. Diabetic ketoacidosis. Pregnancy, therapies. q110mcmol/l in females and/or ccQ70ml/min), lactation. Avoid hypoglycaemia while driving. dehydration, severe infection, shock, intravascular P Initially 5mcg twice daily, for at least 1 C Oral antidiabetic agents, ACE inhibitors, administration of iodinated contrast agents. month. Can then increase to 10mcg twice daily. disopyramide, fibrates, fluoxetine, MAOIs, Doses q 10mcg twice daily, not recommended. Pregnancy, lactation. pentoxifylline, propoxyphene, salicylates, Admin. as SC inj. in thigh, abdomen, or upper B Ischaemic heart disease and/or sulphonamides. Corticosteroids, danazol, arm, within 60 min. before morning and evening peripheral arterial disease (not recommended). diazoxide, diuretics, glucagons, isoniazid, Monitor renal function at least once a year, and 2- meal. When added to metformin therapy, phenothiazine derivatives, somatropin, continue current metformin dose. When added to 4 times a year in elderly or patients at risk. sympathomimetics, thyroid hormones, estrogens, Monitor for fluid retention, other signs of cardiac sulphonylurea therapy, consider sulphonylurea progestins, protease inhibitors, atypical dose reduction. Moderate renal impairment: failure. Monitor liver enzymes prior to initiation antipsychotics, b-blockers, clonidine, lithium, Caution, increasing 5mcg-10mcg. and periodically thereafter. Lactic acidosis alcohol, pentamidine guanethidine, reserpine. R Caution, increasing 5mcg-10mcg in (discontinue if suspected). Monitor weight. A Hypoglycaemia, inj. site reactions, local patients q70 years. Over q 75 years, limited Discontinue 48 hrs before surgery and resume 48 experience. hypersensitivity reactions. hrs after. Contains lactose. Q Under 18 years, not recommended. C Discontinue before IV inj. of iodinated APROVEL sanofi-aventis/BMS contrast agents and resume 48 hrs after. Not D Pregnancy, lactation. 2MO reommended: Insulin (use only in exceptional cases B Not for use in Type 1 diabetes, diabetic ketoacidosis or Type 2 diabetes patients who Angiotensin II antagonist. Irbesartan 75mg,150mg, and under close supervision). Avoid alcohol. require insulin. IV/IM inj., not recommended. EndCaution: Gemfibrozil, rifampicin, other CYP2C8 300mg. White oval tabs. marked with heart stage renal disease or severe renal impairment inducers, glucocorticoids, b-2-agonists, diuretics, symbol and 2771, 2772 or 2773 resp. 75mg-28, (ccQ30ml/min), severe GI disease; not A16.49; 150mg-28, A18.33; 300mg-28, A24.74. ACE inhibitors. recommended. Patients with BMI R 25, limited A Anaemia, GI upset, hypoglycaemia, S Renal disease in patient with experience. May rarely occur: Altered renal weight gain, oedema, cardiac ischaemia, hypertension and type 2 diabetes mellitus. function, acute pancreatitis (discontinue if occurs); P Initially 150mg once daily and titrate up hypercholesterolaemia. resolution of pancreatitis has been observed with to 300mg once daily. Haemodialyses patients supportive treatment but very rare cases of AVANDIA GSK consider using initial dose of 75mg once daily. necrotizing or hemorrhagic pancreatitis and/or R Over 75 years, initiate with 75mg once 2NO death reported. Contains metacresol. Avoid daily. Thiazolidinedione. Rosiglitazone (maleate) 4mg, hypoglycaemia while driving/using machines. D Pregnancy. 8mg. Orange, red/brown film-ctd tabs marked C Not recommended: Insulin, DB Renovascular hypertension, renal with SB and strength. 4mg-28, A35.36; 56, phenylalanine derivatives, meglitinides, aimpairment, hyperkalaemia, aortic or mitral valve A70.71; 8mg-28, A63.78. glucosidase inhibitors; no data. Caution: Oral stenosis, obstructive hypertrophic cardiomyopathy, S Oral monotherapy treatment of type 2 medicines requiring rapid GI absorption, or with a primary aldosteronism. If inadvertently taken narrow therapeutic ratio, or dependent on diabetes in patients (particularly overweight threshold concentrations for efficacy; see SPC. patients) inadequately controlled by diet and PRESCRIBING NOTES Gastro-resistant formulations containing exercise for whom metformin is inappropriate. In DIABETES substances sensitive for degradation in the dual/triple therapy combination with metformin All insulin-dependent diabetic athletes are stomach e.g. PPIs, take r 1 hour before or q 4 and/or sulphonylurea. required to apply for a standard Therapeutic Use hours after. Caution: Warfarin/cumarol derivatives. P Initially 4mg daily. Monotherapy and Exemption (TUE) to cover their insulin use. See A Hypoglycaemia, decreased appetite, combination therapy with metformin/ Summary of WADA list. sulphonylurea: Increase to 8mg daily after 8 weeks headache, dizziness, GI disorders, hyperhidrosis,
thiazide diuretics, thyroid stimulating agents, glucocorticoids. Phenothiazine derivatives, chlorpromazine, adrenaline and sympathicomimetics. Nicotinic acid (high dosages) and nicotinic acid derivatives. Laxatives (long term use), phenytoin, diazoxide, glucagon, barbiturates, rifampicin, acetazolamide. H2 antagonists, betablockers, clonidine, reserpine, guanethidine. A Visual disturbances (transient), hepatic enzymes increased. Hypersensitivity reactions of the skin may occur as pruritius, rash, urticaria and photosensitivity.
during pregnancy, check skull and renal function with echography. Lactation not recommended (esp. newborn or preterm infants). Contains lactose. C K+sparing diuretics, K+suppl., lithium. A Headache, musculo-skeletal trauma, flushing.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
173
6.4 DIABETES
HORMONES
MELLITUS monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc.
feeling jittery, asthenia.
COMPETACT
Takeda Hepatic impairment, renal impairment, renal
2MO Thiazolidinedione/biguanide Pioglitazone (HCI) 15mg, metformin (HCI) 850mg. White, oblong, film-ctd tab., marked 15/850 on one face and 4833M on reverse. 56, A48.10. S Type 2 diabetes mellitus, particularly in overweight patients, who are unable to achieve sufficient glycaemic control at their max. tolerated dose of oral metformin alone. P One tab., taken twice a day. Take with, or just after food. Consider dose titration with pioglitazone (added to optimal metformin dose) before switching. When clinically appropriate, direct change from metformin monotherapy may be considered. Q Under 18 years, not recommended. D Cardiac failure (or history of) NYHA stages I to IV, acute or chronic disease which may cause tissue hypoxia (e.g. cardiac/respiratory failure, recent MI, shock). Acute alcohol intoxication, alcoholism. Diabetic ketoacidosis/precoma. Renal failure/dysfunction (ccQ60 ml/min), acute conditions affecting renal function (dehydration, severe infection, shock). Pregnancy, lactation. B Lactic acidosis, discontinue if suspected. Monitor renal function at least once a year, and 24 times if cc at ULN and in elderly. Can cause fluid retention; monitor for HF and discontinue if deterioration in cardiac status. Monitor liver enzymes periodically; do not initiate if ALT q 2.5 X ULN or any other evidence of liver disease and discontinue if ALT increases to 3 X ULN or jaundice occurs during therapy. Monitor weight gain. Possibility of macular oedema, if disturbances in visual acuity; consider ophthalmological referral. Discontinue 48 hours before surgery and resume 48 hours afterwards. Long term use: Consider risk of fractures. C Discontinue before IV admin. of iodinated contrast agents and resume 48 hours afterwards. Avoid alcohol. Caution: Cationic drugs eliminated by renal tubular secretion, gemfibrozil, rifampicin, glucocorticoids, b-beta-2-agonists, diuretics, ACE-inhibitors, insulin. A Anaemia, visual disturbance, weight increased, arthralgia, headache, haematuria, erectile dysfunction, oedema, upper RTIs, hypoaesthesia, taste disturbance, GI disorders.
COZAAR
artery stenosis, primary aldosteronism (not recommended), aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. No sufficient therapeutic experience: HF with concomitant severe renal impairment, severe HF, HF and symptomatic life threatening cardiac arrhythmias. Lactation (not recommended). Tabs contain lactose. C Rifampicin, fluconazole, NSAID, K+ sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, asthenia/fatigue, hyperkalaemia, hypoglycaemia.
COZATAN
Angiotensin II antagonist. Losartan (K+), 50mg, 100mg. Resp. round or oblong biconvex white film-ctd tab. with breaking notch on both sides. Can be divided into equal quarters or halves. 50mg-28, A9.54; 100mg-28, A16.03. S Renal disease in patients with hypertension and type 2 diabetes with proteinuria r0.5g/day as part of antihypertensive treatment. P Initially 50mg once daily. May be increased to 100mg once daily based on BP response from 1 month after initiation onwards. May be admin. with other antihypertensives as well as hypoglycaemics. Intravascular volume depletion: Consider 25mg once daily initially. Hepatic impairment: Consider lower dose. R As per adults. q75 years, consider initiating therapy with 25mg. D Severe hepatic impairment. Pregnancy, lactation. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension (correct prior to initiating or use lower starting dose). Monitor K+ and cc. Caution: Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Monitor renal function regularly. No sufficient therapeutic experience: HF with concomitant
MSD
2MO Angiotensin II antagonist. Losartan (K+) 12.5mg, 50mg, 100mg. White film-ctd scored tab. marked 952, white film-ctd teardrop-shaped tab. marked 960. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg28, A30.80.
2MO ALSO COZAAR ORAL SUSPENSION Losartan K+, 2.5mg/ml (reconstituted susp.). White to off-white powder and cloudy, colorless solvent for oral sus. 500mg/200ml, A50. S Renal disease in adults with hypertension and type 2 diabetes mellitus with proteinuria r 0.5g/day as part of antihypertensive treatment. P 50mg once daily. If necessary, increase to max. 100mg once daily. Q Not recommended. D Severe hepatic impairment. Pregnancy. B History of angiooedema (closely
174
Clonmel
2MO
severe renal impairment, severe HF (NYHA class IV), HF and symptomatic life threatening cardiac arrhythmias. Contains lactose. C Not recommended: K+ sparing diuretics, K+ supplements or salts, ACE inhibitors. Caution: Other antihypertensives, TCAs, antipsychotics, baclofen, amifostine, fluconazole, rifampicin, lithium, NSAIDs. A Dizziness, hypotension, asthenia/fatigue, hypoglycaemia, hyperkalaemia.
DAONIL
sanofi-aventis
2MO Sulphonylurea. Glibenclamide 5mg. White oblong scored tab. marked LDI with symbol. 100, A11.18.
2MO ALSO SEMI-DAONIL Glibenclamide 2.5mg. White scored tab. marked LBG with symbol. 30, A2.01. S Type 2 diabetes mellitus who respond inadequately to dietary measures. P Initially 5mg once daily at breakfast. Adjust at weekly intervals to max. 15mg daily, if necessary. Q Not applicable. D Diabetic ketoacidosis, diabetic coma/precoma, type 1 diabetes, renal, hepatic or adrenocortical impairment, circumstances of unusual stress (e.g. surgical operations). Sulphonylurea or sulphonamide intolerance. Brittle or juvenile diabetes, pregnancy, lactation, children, treatment with bosentan. B Stress situations (e.g. trauma, surgery, infection): may be necessary to discontinue and admin insulin. G6PD deficiency. Risk of hypoglycaemia or haemolytic anaemia. Contains lactose. C Bosentan (contra). Insulin, other oral anti-diabetics, ACE inhibitors, anabolic steroids, male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, ifosfamide, MAOIs, miconazole, PAS acid, pentoxifylline, phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulphinyrazone, sulfonamides, sympatholytic agents, b-blockers, guanethidine, clarithromycin, tetracyclines, tritoqualine, trosfosfamide. Acetazolamide, barbiturates,
PRESCRIBING NOTES Interaction between insulin and other medicinal products A number of substances are known to interact with glucose metabolism. When administered in diabetic patients in combination with insulin, insulin dosage may need to be adjusted. Substances that have a hyperglycaemic activity and may increase insulin requirements: oral contraceptives thiazides glucocorticoids thyroid hormones sympathomimetics danazol Substances that have a hypoglycaemic activity and may decrease insulin requirements: oral hypoglycaemics, octreotide, lanreotide certain antidepressants (MAOIs, SSRIs) non-selective b-blockers certain ACE inhibitors (captopril, enalapril) angiotensin II receptor blockers salicylates alcohol anabolic steroids sulphonamides Keep in mind that b-blocking agents may mask the symptoms of hypoglycaemia and alcohol may intensify and prolong the hypoglycaemic effect of insulin. Updated August 2007.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES corticosteroids, diazoxide, diuretics, epinephrine and other sympathomimetic agents, glucagon, laxatives, nicotinic acid, oestrogens, progestogens, phenothiazines, phenytoin, thyroid hormones, rifampicin, H2-receptor antagonists, clonidine, reserpine, cyclosporine, alcohol. A Hypoglycaemia, temporary visual impairment, gastrointestinal disturbances, liver function disturbances, cholestatic jaundice, changes in blood picture, purpura, skin rashes, allergic vasculitis, photosensitivity.
DIABETES
MELLITUS
6.4
NSAIDs, chlorpromazine, glucocorticoids, ritodrine, salbutamol, intravenous terbutaline, anticoagulant therapy (e.g. warfarin). A Hypoglycaemia.
recommended: CHF NYHA Class III-IV. Caution: CHF NYHA Class I-II. Monitor for skin disorders, such as blistering or ulceration. Discontinue 48 hours before elective surgery with general anaesthesia and for 48 hours afterwards. DIAMICRON MR Servier C Not recommended: Iodinated contrast media. Avoid alcohol. Cationic active substances 2MO eliminated by renal tubular secretion (e.g. Sulphonylurea. Gliclazide 30mg. Modified release white oblong tab. marked with logo one side and cimetidine). Caution: Glucocorticoids, b2-agonists, diuretics, ACE inhibitors, thiazides, corticosteroids, DIA 30 on reverse. 60, A4.25. S Non insulin-dependent diabetes (type 2) thyroid products and sympathomimetics, in adults when dietary measures, physical exercise antihypertensive, diuretic, NSAID. DIABREZIDE Helsinn Birex and weight loss alone are not sufficient to control A Tremor, headache, dizziness, fatigue, GI disorders, metallic taste, hypoglycaemia. 2MO blood glucose. Sulphonylurea. Gliclazide 80mg. White scored tab. P 1-4 once daily with breakfast, GALVUS Novartis depending on response. 60, A2.92. 2MO Q Not applicable. S Treatment of type II diabetes mellitus, D See SPC. inadequately controlled by non-pharmaceutical DPP-4 inhibitor. Vildagliptin 50mg. White to light means. yellowish, round (8mm diameter), flat-faced, Novartis bevelled-edge tab. debossed with NVR one side, P v-1 daily increasing to a max. of 4 daily EUCREAS where necessary. Daily doses of 2 tabs. or more FB the other. 56, A43.10. 2MO should be taken in 2 divided doses. S Type 2 diabetes mellitus. As dual oral DPP-4 inhibitor/biguanide. Vildagliptin 50mg; Q Not recommended. therapy in combination with: metformin, in metformin HCl 850mg (eq. to metformin 660mg) D See SPC. patients with insufficient glycaemic control despite or 1000mg (eq. to metformin 780mg). Resp. maximal tolerated dose of monotherapy with yellow or dark yellow, ovaloid film-ctd tab. with DIACLIDE Gerard metformin; a sulphonylurea, in patients with bevelled edge, imprinted with NVR one side and insufficient glycaemic control despite maximal 2MO A SEH or FLO the other. 50mg/850mg-60, 46.18; tolerated dose of a sulphonylurea and for whom Sulphonylurea. Gliclazide 80mg. White scored tab. 50mg/1000mg-60, A46.18. metformin is inappropriate due to marked GZ80 one side and G on reverse. 60, S Treatment of type 2 diabetes mellitus contraindications or intolerance; a A5.04. patients unable to achieve sufficient glycaemic S Treatment of maturity onset diabetes control at their max tolerated oral metformin dose thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a mellitus, where insulin therapy is not required and alone or who are already treated with the thiazolidinedione is appropriate. dietary modifications have failed to control combination of vildagliptin and metformin as P Wth metformin or a thiazolidinedione: hyperglycaemia. separate tabs. 100mg (50mg morning; 50mg evening). With a P 40-320mg total daily dose. Single dose P Initially, either one 50mg/850mg or sulphonylurea: 50mg once daily (morning). Safety should not exceed 160mg, when higher doses are 50mg/1000mg tab. strength twice daily (1 tab. and efficacy not established as triple oral therapy required dose should be divided twice daily with morning; 1 tab. evening), based on patient’s main meals and in conjunction with a calorie and current metformin dose. Recommended daily dose: in combination with metformin and a thiazolidinedione or with metformin and a carbohydrate restricted diet. May be used in 100mg vildagliptin + 2000mg metformin HCl. combination with biguanide if necessary. Patients receiving vildagliptin and metformin from sulphonylurea. R r75 years, caution. Q Not recommended. separate tabs may be switched to Eucreas Q Not recommended. D See SPC. containing same doses of each. Doses q 100mg D Pregnancy, lactation. vildagliptin not recommended. No clinical DIAGLYC Teva experience of vildagliptin and metformin in triple B Not for type 1 diabetes or diabetic ketoacidosis. Not recommended: Moderate to 2MO combination with other antidiabetics. Taking severe renal impairment; patients with end-stage Sulphonylurea. Gliclazide 30mg. White, oval, Eucreas with or just after food may reduce GI renal disease on haemodialysis, hepatic biconvex modified-release tab. 60, A 6.03. symptoms. impairment (including patients with pre-treatment S Non insulin-dependent diabetes (type 2) R Monitor renal function regularly. q 75 ALT or AST q 3x ULN), CHF of NYHA class III-IV. in adults when dietary measures, physical exercise years, not recommended. Monitor liver function before and during and weight loss alone are not sufficient to control Q Not recommended. treatment (at 3-month intervals during 1st year blood glucose. D Diabetic ketoacidosis or diabetic preand periodically thereafter). If transaminase levels P 30-120mg in a single intake at breakfast coma. Renal failure/dysfunction (ccQ 60 ml/min). increase, frequent monitoring required until time. Initially 30mg daily. If blood glucose is not Acute conditions with potential to alter renal return to normal; withdrawal recommended if AST adequately controlled, the dose may be increased function, (dehydration, severe infection, shock, or ALT levels of 3x ULN or greater persist. in successive steps to 60, 90 or 120mg daily. intravascular administration of iodinated contrast Switching from 80mg immediate release tablet: agents). Acute or chronic disease which may cause Discontinue if jaundice or other signs suggestive of liver dysfunction occur. Caution: Congestive Monitor blood glucose carefully. Patients at risk of tissue hypoxia (cardiac or respiratory failure, heart failure of NYHA functional class I-II. Monitor hypoglycaemia: 30mg. Switching from other oral recent MI, shock). Hepatic impairment. Acute for skin disorders, such as blistering or ulceration. antidiabetics and in combination with other alcohol intoxication, alcoholism. Lactation. Hepatic dysfunction (incl. hepatitis) and antidiabetics: See SPC. Pregnancy. angioedema reported rarely. Contains lactose. Q Under 18 years, not recommended. B Not for type 1 diabetes. Lactic acidosis C Hypoglycaemic effect may be reduced D Type 1 diabetes. Diabetic pre-coma and may occur (discontinue and hospitalise if by thiazides, corticosteroids, thyroid products, coma, diabetic keto-acidosis. Severe renal or suspected). Monitor serum creatinine sympathomimetics. hepatic insufficiency. Treatment with miconazole. concentration regularly (once a year in patients A With metformin: Hypoglycaemia, Lactation. Pregnancy. with normal renal function; 2 to 4 times a year if tremor, headache, dizziness, fatigue, nausea. With B Hepatic insufficiency, severe renal serum creatinine levels at the upper limit of a sulphonylurea: Hypoglycaemia, tremor, failure. Careful selection of patients needed to normal and in elderly). Monitor liver function reduce risk of hypoglycaemic episodes. Contains before and during treatment (at 3-month intervals headache, dizziness, asthenia. With a lactose. during the first year and periodically thereafter). If thiazolidinedione: Weight increase, oedema C Contra: Miconazole. Not recommended: transaminase levels increase, frequent monitoring peripheral. Phenylbutazone, alcohol, danazol. Caution: Other required until levels return to normal; withdrawal GLIBENESE Pfizer antidiabetics, b-blockers, fluconazole, angiotensin recommended if AST or ALT levels of 3x ULN or 2MO converting enzyme inhibitors (captopril, enalapril), greater persist. Discontinue if jaundice or other Sulphonylurea. Glipizide 5mg. White, capsularH2-receptor antagonists, MAOIs, sulfonamides, signs suggestive of liver dysfunction occur. Not AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
175
6.4 DIABETES
HORMONES
MELLITUS
shaped, scored tab, engraved Y2 on one side. 56, A4.35. S Maturity-onset diabetes. P Initially 5mg daily with breakfast or lunch, increasing if necessary by 2.5 or 5mg daily several days apart. Doses q 15mg daily should be taken in divided doses with main meals. Maintenance, usually 2.5-20mg daily. Max. 20mg daily. High risk patients: Initially 2.5mg. R Initially 2.5mg. Q Not applicable. D Type I or severe or unstable diabetes. Diabetic ketoacidosis/coma or diabetes complicated by major surgery, severe sepsis/ trauma. Severe renal, hepatic or thyroid impairment; coexistent renal and hepatic disease. Pregnancy, lactation. B May be necessary to discontinue and admin insulin if patient exposed to stress (e.g. fever, trauma, infection, surgery). Renal/hepatic disease. C Miconazole, fluconazole, NSAIDs, salicylates, alcohol, b-blockers, ACEs, H2 receptor antagonists, MAOIs, sulphonamides, chloramphenicol, probenecid, coumarins, phenothiazines, corticosteroids, sympathomimetics, diuretics, thyroid products, oestrogens, progestogens, phenytoin, nicotinic acid, Ca++ channel blockers, isoniazid. A Hypoglycaemia, GI disorders.
symptoms). A Flatulence, bloating, nausea, abdominal pain, diarrhoea, post-prandial fullness.
GLUCOPHAGE
Merck Serono
2MO
Biguanide. Metformin (HCl) 500mg, 850mg, 1000mg. 500mg/850mg: White, circular convex film-ctd tabs. 1000mg: Oval biconvex film-ctd scored tab. marked 1000 on one side. 500mg-84, A1.96; 850mg-56, A2.17; 1000mg-60, A5.77. S Type 2 diabetes mellitus particularly in overweight patients (alone or with other oral antidiabetic agents or insulin). P One 500mg or 850mg 2 or 3 times daily with or after meals. Adjust dose after 10-15 days on the basis of blood glucose measurements. At higher doses can replace two 500mg tab. with one 1000mg tab. Max. 3g daily. Q 10 years and older, one 500mg or 850mg once daily with or after meals. Adjust dose after 10-15 days on the basis of blood glucose measurements. Max. 2g daily as 2 or 3 divided doses. D Diabetic ketoacidosis, diabetic pre-coma. Renal failure/dysfunction (ccQ60ml/min), dehydration, severe infection. Cardiac or respiratory failure, recent MI, shock. Hepatic insufficiency, acute alcohol intoxication, alcoholism. Lactation, Pregnancy. Lactic acidosis (discontinue if suspected). GLUCAGEN HYPOKIT Novo Nordisk B Impaired renal function. Monitor serum cc levels 2NO at least annually if normal renal function, and 2-4 Hyperglycaemic. Glucagon 1mg. Lyophilised times a year if cc levels at ULN and in elderly. powder in vials plus solvent in syringe and vial. Children (especially pre-pubescent), general 1mg vial plus solvent in syringe A19.19. anaesthesia (within 48 hrs). S Diabetic hypoglycaemia. C Not recommended: Iodinated contrast V 1-2mg SC, IM or IV; may be repeated agents, alcohol. Caution: Insulin, sulfonylureas, after 20 minutes. glucocorticoids, b2-agonists, ACE inhibitors, D See SPC. antihypertensives, diuretics, NSAIDs. A Taste disturbance, GI disorders.
GLUCOBAY
Bayer Schering
2MO a-glucosidase inhibitor. Acarbose 50mg, 100mg. Both white to yellow-tinged tab. with Bayer cross on one side; marked G50 and Gscore100 resp. on reverse. 100mg: Oval, oblong, convex tab., scored on one side. 50mg-90, A15.33; 100mg-90, A19.26. S Insulin dependent diabetes as adjunct to diet, in combination with insulin or non-insulin dependent diabetes as adjunct to diet, alone or in combination with insulin or oral hypoglycaemic agents. P Initially 50mg three times daily with or before meals OR initiate treatment at 50mg once or twice daily (to minimise GI side effects) with subsequent titration to 3 times daily. Titrate if necessary after 6-8 weeks, to 100mg three times daily. Max. 200mg three times daily. Q Under 18 years, not recommended. D Severe renal impairment. Inflammatory bowel disorders, colonic ulceration, intestinal obstruction, chronic digestive or absorption disorders, conditions exacerbated by flatulence. Pregnancy, lactation. B Monitor hepatic transaminase on max. dose, review if persistently elevated. Monitor liver enzymes. GI reactions may be severe and might be confused with paralytic ileus. C Avoid: Adsorbents, pancreatic enzymes, colestyramine. Caution: Neomycin, digoxin. Monitor closely patients on other hypoglycaemics. Antacids containing magnesium and aluminium salts (not recommended to ameliorate GI
176
HUMALOG
HUMALOG MIX 25
Lilly
5MO Biphasic insulin prep. Insulin lispro (25% insulin lispro soln.; 75% insulin lispro protamine susp.). Cartridge: 5 x 3ml, A33.29; Pre-filled Pen and KwikPen: 5 x 3ml, A36.80.
5MO ALSO HUMALOG MIX 50 Insulin lispro (50% insulin lispro soln.; 50% insulin lispro protamine susp.) Pre-filled Pen and KwikPen: 5 x 3ml, A37.97. S Diabetes mellitus. P Dosage should be determined according to patient requirement. May be given shortly before or soon after meals by SC inj. in the upper arms, thighs, buttocks or abdomen. Inj. site should be rotated. Not for IV admin. D Hypoglycaemia. B Dosage adjustment may be required: When transferring to another type or brand of insulin, renal impairment, hepatic impairment due to reduced gluconeogenesis and insulin breakdown, chronic hepatic impairment, illness or emotional disturbances, change in physical activity or diet, pregnancy, lactation. Avoid hypoglycaemia whilst driving. C Substances that may affect insulin requirements: See Prescribing Note. A Hypoglycaemia. Local allergy at inj. site.
HUMULIN S
Lilly
5MO Short-acting insulin. Human soluble insulin (prb) 100 IU/ml. Cartridge: For use with HumaPen-5 x 3ml, A27.78. Vial: 1 x 10ml, A12.98. S Diabetes mellitus where insulin is required for maintenance of glucose homeostasis. P By SC, IM or IV inj. Dosage according to individual requirements. Duration approx. 12 hours.
Lilly 5 M O
5MO Very rapidly-acting insulin. Insulin lispro 100 IU/ml. Soln. for inj. Cartridges: 3ml-5, A34.93. Vial: 10ml1, A18.58. Pre-filled Pen and KwikPen: 3ml-5, A39.44. S Diabetes mellitus. P By SC inj. or continuous SC inf. with certain Minimed and Disetronic insulin pumps; if necessary by IM inj. and IV inj. Dosage according to individual requirements. May be given shortly before or soon after meals. Onset approx. 15 mins; duration 2-5 hours. Can be used in conjunction with longer-acting human insulin or oral sulphonylurea agents. Q Use in preference to soluble insulin only when fast action of insulin might be beneficial (e.g. timing of inj. in relation to meals). D Hypoglycaemia. B Dosage adjustment: When transferring to another type or brand of insulin, renal impairment, hepatic impairment due to reduced gluconeogenesis and insulin breakdown, chronic hepatic impairment, illness or emotional disturbances, change in physical activity or diet, pregnancy, lactation. Optimise dosage of both basal and fast-acting insulins. Avoid hypoglycaemia whilst driving. C Substances that may affect insulin requirements: See Prescribing Note. A Hypoglycaemia. Local allergy at inj. site.
ALSO HUMULIN I Human isophane insulin (prb) 100 IU/ml. 5 x 3ml, A33.43; Cartridges: For HumaPen-5 x 3ml, A27.78; Vial: 1 x 10ml, A11.81; Pre-filled pens: 5 x 3ml, A32.32. S Diabetes mellitus. P By SC or IM inj. Dosage according to individual requirements. Duration approx. 22 hours.
5MO ALSO HUMULIN M3 Human insulin (prb) in the proportion of 30% soluble, 70% isophane insulin 100 IU/ml. Cartridges: For HumaPen-5 x 3ml, A27.78; Vial: 1 x 10ml, A11.81. S Diabetes mellitus. P By SC or IM inj. according to individual requirements. Duration approx. 22 hours. D Hypoglycaemia. IV admin. (except Humulin Soluble). B Dose adjustment: Transfering to another type or brand of insulin, renal / hepatic impairment, diseases of the adrenal, pituitary or thyroid glands, illness or emotional disturbances, change in physical activity or diet. Pregnancy, lactation. Avoid hypoglycaemia whilst driving. C Substances that decrease or increase insulin requirements: See Prescribing Note. Somatostatin analogues are both hyper/ hypoglycaemic. A Lipodystrophy at inj. site. Hypoglycaemia. Local allergy at inj. site. Systemic allergy.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES INSULATARD
DIABETES Novo Nordisk
JANUMET
MSD
5MO
2MO
Intermediate-acting insulin. Insulin isophane inj. 100 IU/ml. Vial. 1x10ml, A11.03.
DPP-4 inhibitor/biguanide. Sitagliptin (as phosphate monohydrate)/ metformin HCl 50mg/ 850mg, 50mg/1000mg. Pink or red cap.-shaped film-ctd tab. marked 515 or 577, resp. 50m/850-56, A44.52; 50/1000-56, A44.52. S Type 2 diabetes mellitus. Adjunct to diet and exercise in patients inadequately controlled on their max. tolerated metformin dose alone or those already being treated with sitagliptin and metformin combination. In combination with a sulphonylurea (triple combination therapy) as adjunct to diet and exercise in patients inadequately controlled on their max. tolerated metformin dose and a sulphonylurea. As a triple combination therapy with a PPAR gamma agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their max tolerated metformin dose and a PPAR gamma agonist. As an add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control. P Inadequate control on metformin: Starting dose should provide 50mg sitagliptin twice daily (100mg total daily dose) plus the metformin dose already being taken. Switching from sitagliptin and metformin: Initiate at doses already being taken. Inadequate control on metformin plus sulphonylurea: Dose should provide 50mg sitagliptin twice daily (100mg total daily dose) and metformin dose similar to dose already being taken. Combination with a sulphonylurea may require lower dose of the sulphonylurea (risk of hypoglycaemia). Inadequate control on metformin plus PPAR gamma agonist: Dose should provide 50mg sitagliptin twice daily (100mg total daily dose) and a dose of metformin similar to dose already being taken. Inadequate control on dual combination therapy with insulin and max. tolerated metformin dose: Dose should provide sitagliptin 50mg twice daily (100mg total daily dose) and metformin dose similar to dose already being taken. Combination with insulin may require lower insulin dose (risk of hypoglycaemia). R Use with caution, monitor renal function. Q Under 18 years, not recommended. D Diabetic ketoacidosis, diabetic pre-coma, moderate and severe renal impairment (ccQ 60ml/ min), acute conditions with potential to alter renal function (dehydration, severe infection, shock, intravascular administration of iodinated contrast agents), acute or chronic disease which may cause tissue hypoxia (cardiac or respiratory failure, recent myocardial infarction, shock), hepatic impairment, acute alcohol intoxication, alcoholism, pregnancy, lactation. B Not suitable for type 1 diabetes. May occur: Lactic acidosis (discontinue and hospitalise immediately), hypoglycaemia, hypersensitivity reactions. Monitor serum creatinine levels. Discontinue 48 hrs before elective surgery; resume 48hrs after surgery if renal function normal. Discontinue prior to intravascular administration of iodinated contrast agent, resume 48hrs if renal function normal. If laboratory abnormalities or clinical illness develop, check for evidence of ketoacidosis or lactic acidosis. C Alcohol, cimetidine, iodinated contrast agents, glucocorticoids (systemic and local) b2-
5MO ALSO INSULATARD PENFILL Insulin isophane inj. 100 IU/ml. 3ml cartridges for use with NovoPen 3 metered-dose inj. device. Cartridge: 5 x 3ml, A30.48. NovoPen 3 supplied free of charge by Novo Nordisk, freephone 1850 665 665.
5MO ALSO INSULATARD INNOLET Insulin isophane inj. 100 IU/ml. 3ml pre-loaded multi-dose, disposable inj. device. 5 x 3ml, A35.73. S Diabetes mellitus. V By SC inj. In accordance with individual requirements. Duration approx. 24 hrs. D Hypoglycaemia.
INSUMAN BASAL
sanofi-aventis
5MO Intermediate-acting insulin. Human insulin (emp) 100 IU/ml. Crystalline protamine sulphate with preservative. 3ml cartridge for Optipen device; 5ml multidose vial and 3ml Optiset. Cartridge: 5 x 3ml, A28.48; Vial: 1 x 5ml, A6.69; Optiset: 5 x 3ml, A34.14. S Insulin-dependent diabetes mellitus. V By SC inj. according to individual requirements 45-60 mins before meal. Duration approx. 11-20 hours. B Avoid IV or IM admin. Rotate SC inj. site. Caution: Hepatic/renal impairment, stenosis of coronary artery or blood vessels to brain. Elderly, psychiatric illness, neuropathy, regimen change, insulin sensitivity, missed meals, inadequate food intake, prolonged physical activity, alcohol intake, require close monitoring. Concurrent illness e.g. influenza: Insulin requirement increased. Never stop admin. entirely. Regular blood glucose checks. Lactation (adjust dose). Driving/using machines. C Substances that may affect insulin requirements: See prescribing note. A Hypoglycaemia, visual impairment, lipodystrophy at inj. site.
INSUMAN COMB
sanofi-aventis
5MO Biphasic insulin prep. Human insulin 100 IU/ml. Dissolved insulin / crystalline protamine insulin 50/ 50% (Insuman Comb 50), 25/75% (Insuman Comb 25), 15/85% (Insuman Comb 15). Cartridge for Optipen device (Comb 50, Comb 25): 5 x 3ml, A28.48; Vial (Comb 25): 1 x 5ml, A6.69; Optiset (Comb 50, Comb 25, Comb 15): 5 x 3ml, A34.14. S Insulin-dependent diabetes melitus. V By SC or IM inj. according to individual requirements. D See SPC.
INSUMAN RAPID
sanofi-aventis
5MO Short-acting insulin. Human insulin (emp) 100 IU/ ml. Neutral soln. with preservative. Cartridge for Optipen device: 5 x 3ml, A28.48; Optiset: 5 x 3ml, A34.14. S Insulin-dependent diabetes melitus. V By SC or IM inj according to individual requirements 15-20 mins. before a meal. Duration approx. 7-9 hours. D See SPC.
MELLITUS
6.4
agonists, ACE-inhibitors, potent CYP3A4 inhibitors, probenecid, digoxin. A With metformin: Nausea. With metformin and sulphonylurea: Hypoglycaemia, constipation. With PPAR gamma agent and metformin: Headache, diarrhoea, vomiting, hypoglycaemia. With insulin and metformin: Hypoglycaemia
JANUVIA
MSD
2MO DPP-4 inhibitor. Sitagliptin (phosphate monohydrate), equiv. sitagliptin 100mg. Round, beige film-ctd tab. marked 277. 28, A43.10. S Type 2 diabetes mellitus, to improve glycaemic control: When diet and exercise alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance; in combination with metformin and/or sulphonylurea when diet or exercise plus metformin and/or sulphonylurea do not provide adequate glycaemic control or metformin is contraindicated or not tolerated; in combination with a PPAR gamma agonist (i.e. a thiazolidinedione) when diet and exercise plus PPAR gamma agonist alone do not provide adequate glycaemic control or in combination with the PPAR gamma agonist and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. As an add-on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control. P 1 once daily with or without food. Maintain metformin or PPAR gamma agonist dosage. Missed dose should be taken as soon as remembered. Do not take double dose on same day. In combination with sulphonylurea or with insulin, consider lowering sulphonylurea or insulin dose. Q Under 18 years, not recommended. D Pregnancy, lactation. B Patients r 75 years, severe hepatic insufficiency and moderate/severe renal insufficiency (limited data). May occur: Hypersensitivity reactions and exfoliative skin conditions including Stevens-Johnson syndrome. C Digoxin (caution). A Monotherapy:Headache, hypoglycaemia, constipation, dizziness. With metformin: Nausea. With sulphonylurea: Hypoglycaemia. With metformin and sulphonylurea: Hypoglycaemia, constipation. With PPAR gamma agent: Hypoglycaemia, flatulence, peripheral oedema. With PPAR gamma agent and metformin: Headache, diarrhoea, vomiting, hypoglycaemia, peripheral oedema. With insulin and metformin: Headache, hypoglycaemia, influenza.
LANTUS
sanofi-aventis
5NO Long-acting human insulin analogue. Insulin glargine 3.64mg/ml (equiv. to 100 U/ml human insulin). Clear colourless soln. for inj. Cartridge 100 U/ml 5 x 3ml, A52.87; OptiSet 100 U/ml 5 x 3ml, A54.43; SoloStar 100 U/ml 5 x 3ml, A52.24; Vial 1 x 10ml, A35.00. Optipen Pro 1 supplied free of charge by sanofi-aventis. Freephone 1800 923 488. S Diabetes mellitus where insulin is required. P Once daily by SC inj. individualised to patient need. Reduce Lantus dose by 20-30% when switching from twice daily NPH. Must not
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
177
6.4 DIABETES
HORMONES
MELLITUS
be mixed with other insulin or diluted. Q Under 6 years, not recommended; over 6 years, same as adults. B Diabetic ketoacidosis, impaired liver function, moderate/severe renal impairment, insufficient glucose control, tendency to hyper- or hypoglycaemic episodes. Pregnancy. Not to be admin. by IV inj. C Oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, sulphonamides. Corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogen/progestogen, phenothiazine derivatives, somatropin, sympathomimetics, thyroid hormones. b-blockers, clonidine, lithium salts, alcohol, guanethidine, reserpine. A Hypoglycaemia, lipodystrophy at inj. site, local inj. site reactions.
with NovoPen 3 metered dose inj. device. FlexPen: 5x3ml, A54.43. Cartridge: 5x3 ml, A52.87. NovoPen 3 supplied free of charge by Novo Nordisk, tel. 1850 665 665. S Diabetes mellitus.
5MO
ALSO LEVEMIR INNOLET Insulin detemir 100 U/ml. Pre-filled multi-dose injection device. 5 x 3ml, A51.76. S Diabetes mellitus. P Once or twice daily by SC inj. If twice daily, 2nd dose in the evening or at bedtime. In combination with oral antidiabetics: Initially 10 U or 0.1-0.2 U/kg; titrate based on individual needs (see SPC). Q Efficacy and safety was demonstrated in children and adolescents. Under 6 years, no data. B Avoid IV or IM admin. Avoid mixing with rapid acting insulin. Severe hypoalbuminaemia (monitor carefully). Renal or LESTACE Actavis hepatic impairment, elderly (adjust dose). Adjust dose and timing during transfer from other 2MO ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. insulins; monitor glucose during transfer and in Round tabs, can be divided in equal halves. 2.5mg: initial weeks thereafter. Pregnancy, lactation. Contains metacresol. White, biconvex. 5mg: White, flat, scored both sides. 10mg: Light pink, biconvex, scored one side. C Substances that may affect insulin requirements: See prescribing note. 20mg: Pink, biconvex, scored one side. 2.5mg-28, A Hypoglycaemia, inj. site reactions. A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, A10.16. LISPRIL Rowex S Renal disease in hypertensive patients 2MO with Type 2 diabetes mellitus and incipient nephropathy. ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, 20mg. Slightly red scored tabs. 5mg-30, A8.13; P 10mg once daily; may be increased to 10mg-30, A10.03; 20mg-30, A11.51. 20mg once daily if necessary. Renal impairment, S Early nephropathy in diabetics. ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, P Initially 10mg once daily, increasing to initially 2.5-5mg; 31QccQ80ml/min, initially 520mg once daily if necessary. 10mg/day. R Initially 2.5mg increasing to 5-10mg Q Not recommended. once daily. D History of angioedema associated with Q Not recommended. previous ACE inhibitor therapy. Hereditary or D History of angioneurotic oedema idiopathic angioedema. Pregnancy, lactation. related to previous ACE-inhibitor treatment. B Caution: Acute MI (do not use: Renal Pregnancy, lactation. dysfunction, systolic BP R100mmHg, cardiogenic B Renal impairment, hypotension (1st shock), mitral stenosis and left ventricle outflow dose), aortic stenosis, acute MI, multiple or high obstruction (aortal stenosis, hypertrophic myocardiopathy), bilateral renal artery stenosis or dose diuretic therapy. C K+ suppl., antihypertensive agents, stenosis of the artery in a single kidney (strict sympathomimetics, lithium, antacids, NSAIDs, supervision with low doses; careful dose alcohol, anaesthetics, narcotics, hypnotics, oral adjustment), pre-existing renal impairment hypoglycaemic agents, diuretics, NaCl. (monitor blood K+, creatinine), major surgery, A Hypotension, dry cough, sore throat, anaesthesia, renal insufficiency, diabetes. May bronchitis, dizziness, feeling weak, impaired vision, occur: Systemic hypotension, angioedema nausea, stomach pain, indigestion, rash, headache, (withdraw immediately if occurs), anaphylactoid tiredness, palpitations, renal failure. reactions in haemodialysis patients or during desensitisation treatment, acute renal insufficiency LOAVEL sanofi-aventis in patients with HF (usually reversible), hepatic insufficiency, neutropenia/agranulocytosis, cough. 2 M O C Not recommended: Lithium. Caution: ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, Diuretics, K+-sparing diuretics, K+ containing 10mg. White, yellow, red and white oblong tabs. supplements and salts, NSAIDs (incl. acetylsalicylic with score line on both sides. 1.25mg-28, A2.57; acid r 3g/day), other antihypertensives, injectable 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. gold, certain anaesthetic drugs, TCAs, S Non diabetic and diabetic overt/ antipsychotic agents, sympathicomimetics, antiincipient nephropathy. Prevention of progression diabetics. of microalbuminuria to overt nephropathy. A Dizziness, headache, cough, diarrhoea, P Non diabetic and diabetic overt/ vomiting, renal dysfunction, orthostatic effects incipient nephropathy: Initially 1.25mg once daily (incl. hypotension). titrate according to response; max. 5mg once daily. Discontinue diuretic at least 2-3 days. LEVEMIR Novo Nordisk Hepatic impairment, max. 2.5mg once daily. 5MO Prevention of progression of microalbuminuria to overt nephropathy: Initially 2.5mg once daily Long-acting insulin analogue. Insulin detemir 100 increasing gradually to double the dose after 1 U/ml (recombinant DNA origin, S. cerevisiae). 1 U week and after another 3 weeks to 10mg usual 1 IU human insulin. Soln. for inj. in 3ml premaintenance dose. filled pen (FlexPen) or penfill cartridge for use
178
R Consider initial dose of 1.25mg daily. Titrate according to need for BP control. Q Not recommended. D History of angiooedema. Aortic stenosis or outflow obstruction. Renal artery stenosis, hypotensive or haemodynamically unstable states. Pregnancy, lactation. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: Reduce dose and assess renal function prior to and during treatment. Caution: Patients with hyper stimulated angiotension system. Electrolyte monitoring recommended. Haemodialysis (avoid in patients dialysed with high flux membranes). Malignant hypertension: Initiate in hospital under close supervision. Symotomatic hypotension, agranulocytosis/bone marrow depression, hyperkalaemia have been reported rarely. Caution: Surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, sympathomimetics, antidiabetic agents, NSAIDs. A Nausea, dizziness, headache, dry tickling cough.
LOSARTAN TEVA
Teva
2MO Angiotensin II antagonist. Losartan (K+) 50mg, 100mg. White, oval, slightly arched film-ctd tabs, debossed with strength on one side, scoreline on the other. 50mg-28, A12.45; 100mg-28, A20.94. S Renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria r0.5g/day as part of an antihypertensive treatment. P Initially 50mg once daily. May be increased to 100mg according to BP response after 1 month. May be admin. with other antihypertensives as well as with insulin and other hypoglycaemics. Patients with intravascular volume depletion: 25mg once daily initially. Hepatic impairment: Consider lower dose. R Over 75 years, consider initiating therapy with 25mg. Q Not recommended. D Pregnancy, lactation. Severe hepatic impairment. B History of angioedema (closely monitor). Volume depletion may cause symptomatic hypotension. Monitor K+ and cc. Hepatic impairment, renal impairment, renal artery stenosis, primary aldosteronism (not recommended), ischaemic cardiovascular and cerebrovascular disease, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy. Contains lactose. C Caution: Other antihypertensives, fluconazole, rifampicin, NSAIDs, lithium (monitor levels). Not recommended: Heparin, K+ sparing diuretics, K+ supplements or salts. A Dizziness, hypotension, asthenia/fatigue, hypoglycaemia, hyperkalaemia.
LOTANOS
Rowex
2MO Angiotensin II antagonist. Losartan K+ 50mg, 100mg. White oblong tab. Resp. with 1 or 3 notches on each side and embossed with 3 or 5 on one side. 50mg-28, A11.73; 100mg-28, A19.71. S Renal disease in type 2 diabetes patients with proteinuria, to delay disease progression and to reduce proteinuria. P Initially 50mg once daily. May be increased to 100mg according to BP response.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES D Pregnancy, lactation. B Volume depletion may cause symptomatic hypotension. Caution: Hepatic impairment (dose adjustment), renal impairment (hyperkalaemia risk). May occur: Angioedema, changes in renal function. No data on use in haemodynamically significant obstructive valvular disease. Contains lactose. C Caution: Rifampicin, fluconazole, K+ sparing diuretics, K+ supplements or salt substitutes containing K+, indomethacin. A Dizziness, hypotension, asthenia/fatigue, hyperkalaemia.
DIABETES
MELLITUS
6.4
Q Under 12 years, not recommended. D Type I diabetes, ketoacidosis, severe hepatic impairment. Pregnancy, lactation. B Elderly. C b-blockers, MAOIs, corticosteroids, salicylates, NSAIDs, alcohol, oral contraceptives. A Sensitivity reactions incl. skin rash.
C Potent CYP3A4/5 inducers and inhibitors. A Infections, hypoglycaemia (with sulphonylurea), headache, vomiting, peripheral oedema (with thiazolidinedione).
NOVORAPID FLEXPEN
2NO
Novo Nordisk
STARLIX
Novartis
Phenylalanine derivative. Nateglinide 60mg, 120mg, 180mg. Pink film-ctd tab marked STARLIX one side and 60 on the reverse, yellow ovaloid tab marked STARLIX one side and 120 on reverse, yellow oval film-ctd tab, marked STARLIX one side and 180 on reverse. 60mg-84, A26.46; 120mg-84, MIXTARD 30 Novo Nordisk A28.28; 180mg-84, A28.28. 5MO 5MO ALSO NOVORAPID PENFILL Insulin aspart. 100 IU/ S Combination therapy with metformin in type 2 diabetic patients inadequately controlled Premixed insulin. Insulin mixture, 3 parts soluble ml. (Recombinant DNA origin, S. cervisiae)in 3ml with max. tolerated dose of metformin alone. to 7 parts isophane insulin 100 IU/ml. Vial. 1 x cartridge for use with NovoPen 3 metered dose 10ml, A11.03. inj. device. Cartridges: 5 x 3ml, A36.24; NovoPen 3 P Starting dose is 60mg three times daily before meals. This may be increased to 120mg 5MO supplied free of charge by Novo Nordisk, phone three times daily taken within 1-30 minutes before 1850 665 665. ALSO MIXTARD 30 PENFILL Insulin as isophane meals. Max. single dose is 180mg taken before the insulin 100 IU/ml. Cartridge 5 x 3ml, A30.48. 5MO three main meals. NovoPen 3 supplied free of charge by Novo ALSO NOVORAPID VIAL Insulin aspart. 100IU/ml. Nordisk, freephone 1850 665 665. Recombinant DNA (origin, S. cerevisiae) in a 10ml Q Under 18 years, not recommended. D Type I diabetes, diabetic ketoacidosis, 5MO vial. 1 x 10ml, A22.45. with or without coma, severe hepatic impairment. S Diabetes mellitus. ALSO MIXTARD 30 INNOLET Insulin as isophane Pregnancy, lactation. V Dosage individualised in accordance insulin 100 IU/ml. 3ml pre-loaded multi-dose inj. B Moderate hepatic impairment. Elderly. with patient need. NovoRapid should be given device. 5, A35.73. Should not be used as monotherapy. immediately before or immediately after a meal. S Diabetes mellitus. Hypoglycaemia. V By SC inj. In accordance with individual Under 2 years, no data. C ACE inhibitors, diuretics, corticosteroids, D Hypoglycaemia. requirements. Duration approx. 24 hrs. B Avoid hypoglycaemia whilst driving. Can b2-agonists. D Hypoglycaemia. A Hypersensitivity reactions, elevation in be used in pregnancy (monitor), lactation (adjust liver enzymes. NOVOMIX 30 FLEXPEN Novo Nordisk dose). C Substances that may affect insulin 5MO TRITACE sanofi-aventis requirements: See prescribing note. Biphasic insulin analogue. Soluble insulin aspart/ 2MO protamine-crystallised insulin aspart 100 U/ml in ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, the ratio of 30/70. (Recombinant DNA origin, S. 10mg. White, yellow, red and white oblong tabs. cerevisiae) in a pre-filled disposable pen with score line on both sides. 1.25mg-28, A2.59; comprising a pen injector with a 3ml cartridge. 5 x 3ml, A42.47. 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. 5MO S Non diabetic and diabetic overt/ incipient nephropathy. Prevention of progression ALSO NOVOMIX 30 PENFILL Soluble insulin aspart/ ONGLYZA BMS/AstraZeneca of microalbuminuria to overt nephropathy. protamine-crystallised insulin aspart 100 IU/ml in 2 P Non diabetic and diabetic overt/ the ratio of 30/70. (Recombinant DNA origin, S. DPP-4 inhibitor. Saxagliptin (HCl) 5mg. Pink, incipient nephropathy, the initial dose is 1.25mg cerevisiae) in a 3ml cartridge for use with once daily titrate according to response; max. 5mg NovoPen 3 metered dose inj. device. Cartridge-5 x biconvex, round, film-ctd tab., with 5 printed on one side and 4215 on the other. 28, A38.47. one daily. Discontinue diuretic at least 2-3 days. 3ml, A38.45; NovoPen 3 supplied free of charge S Add-on therapy in adults with type 2 Hepatic impairment, max. 2.5mg once daily. by NovoNordisk phone 1850 665 665. S Diabetes mellitus. diabetes mellitus: With metformin, when Prevention of progression of microalbuminuria to P Dosage is individualised according to metformin alone, with diet and exercise, does not overt nephropathy, the initial dose is 2.5mg once patient need. NovoMix 30 should be given provide adequate glycaemic control; with a daily increasing gradually to double the dose after immediately before or immediately after a meal. sulphonylurea, when the sulphonylurea alone, 1 week and after another 3 weeks to 10mg usual Q Can be used in children aged 10 years with diet and exercise, does not provide adequate maintenance dose. and older. glycaemic control in patients for whom metformin R No special dosage recommendations for D Hypoglycaemia. is inappropriate. With a thiazolidinedione, when elderly patients apart from general warning about the thiazolidinedione alone with diet and exercise, patients with renal or hepatic insufficiency or CHF NOVONORM Novo Nordisk does not provide adequate glycaemic control in which may be common in elderly and concomitant patients for whom a thiazolidinedione is use of diuretic drugs. Dose titrated according to 2MO considered appropriate. need for BP control. Prandial glucose regulator. Repaglinide 0.5mg, Q Not recommended. 1mg, 2mg. White, yellow and red tabs. 0.5mg-120, P 5 mg once daily as add-on therapy. Safety and efficacy not established as part of D History of angioneurotic oedema. Aortic A30.58; 1mg-120, A33.07; 2mg-120, A35.53. triple therapy. stenosis, outflow obstruction. Pregnancy, lactation. S Type 2 diabetes (monotherapy). Also in Q Not recommended. Hypersensitivity to ramipril. combination with metformin. D Pregnancy (unless necessary), lactation. B CHF, hepatic impairment, blood P Initial dose, 0.5mg before each main dyscrasias. Renal impairment: reduce dose and meal (1mg is the max. recommended starting dose B Not for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Not assess renal function prior to and during if transfered from another oral hypoglycaemic recommended: Moderate to severe renal treatment. Haemodialysis (avoid in patients agent). Allow 1-2 weeks between titration steps, impairment, severe hepatic impairment. Safety not dialysed with high flux membranes). Use with as determined by blood glucose response. established: Cardiac failure (NYHA class III-IV), caution in surgery and during anaesthesia. Maintenance, max. single dose 4mg with main immunocompromised. Caution: Moderate hepatic C Antihypertensive agents, K+sparing meals. Total max. daily dose should not exceed diuretics, K+suppl., lithium, antidiabetic agents, impairment, elderly, NYHA class I-II. Monitoring 16mg. Combination with metformin, maintain metformin dose and admin. repaglinide NSAIDs. for skin disorders (blistering, ulceration or rash) concomitantly, starting dose 0.5mg. A Nausea, vomiting, dizziness, fatigue, recommended. Contains lactose.
5MO
Very rapidly acting insulin. Insulin aspart. 100 IU/ ml (recombinant DNA origin, S. cerevisiae). 3ml pre-filled multi-use disposable inj. device. 5 x 3ml, A38.08.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
179
6.5 THYROID
HORMONES
HORMONES AND ANTITHYROID DRUGS
Q Infants, initially 25mcg daily increasing by 25mcg every 2-4 weeks. Over 1 year, initially 2.5-5mcg/kg/day. Reduce slightly once mild toxic symptoms appear. D Thyrotoxicosis. VICTOZA Novo Nordisk B Myocardial or adrenal insufficiency, diabetes mellitus, diabetes insipidus. Elderly. 5MO Human GLP-1 analogue. Liraglutide 6mg/ml. Clear, Pregnancy, lactation. Withdraw gradually. C Caution: Anticoagulants, antidiabetic colourless, isotonic sln for inj. in pre-filled pen. 2, agents, anticonvulsants, tricyclics, cholestyramine, A89.06; 3, A133.59. cardiac glycosides, sympathomimetics, oral S Type 2 diabetes mellitus in adults, to contraceptives. achieve glycaemic control. In combination with A Anginal pain, arrhythmias, tachycardia, metformin or a sulphonylurea, in patients with headache, muscular weakness or cramps, insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or restlessness, excitability, insomnia, flushing, sweats, GI disorders, weight loss. sulphonylurea. In combination with metformin and a sulphonylurea or metformin and a NEO-MERCAZOLE Amdipharm thiazolidinedione in patients with insufficient 2MO glycaemic control despite dual therapy. P Admin by SC inj. in the abdomen, thigh Antithyroid. Carbimazole 5mg, 20mg. Pink tabs. or upper arm, once daily preferably at same time marked Neo and tab. strength one side, plain on every day. Initially, 0.6mg. Allowing minimum 1 reverse. 5mg-100, A5.88; 20mg-100, A21.85. week intervals, increase to 1.2mg and if necessary S Thyrotoxicosis. to 1.8mg max. In combination with a P Initially, 20-60mg daily in 2 or 3 divided sulphonylurea, consider reducing sulphonylurea doses until patient is euthyroid. Maintenance, 5dose (risk of hypoglycaemia, blood glucose self15mg daily for 6-18 months. Alternatively, monitoring may be necessary). Hepatic continue with 20-60mg daily and suppl.al impairment/moderate to severe renal impairment: thyroxine 50-150mcg daily for 6-18 months. Not recommended. Q Initially, 5-15mg daily in divided doses. R r75 years, limited therapeutic D Tracheal obstruction. Lactation. B Pregnancy; See SPC. experience. A Rashes, nausea, headache, arthralgia. Q Under 18 years, not recommended. Bone marrow depression-advise patients to report D Pregnancy, lactation. sore throats, mouth ulcers; discontinue drug. B Not for type 1 diabetes or diabetic ketoacidosis. Caution: CHF NYHA class I-II (limited experience), NYHA class III-IV (no experience). Not 6.6 PAGET’S DISEASE recommended: IBD, diabetic gastroparesis. Risk of ACLASTA Novartis pancreatitis (inform patients; discontinue if 2JN occurs). Thyroid adverse events (increased blood calcitonin, goitre, thyroid neoplasm) reported in Bisphosphonate. Zoledronic acid anhydrous 5mg/ particular in patients with pre-existing thyroid 100ml. Soln for inf. 100ml, A499.84. disease. S Paget’s disease of the bone. C Not recommended: Insulin. Caution: P One IV inf. of 5mg in 100ml aqueous Warfarin. soln over at least 15 min, admin. via vented inf. A With metformin: Decreased appetite, line at constant inf. rate. headache, dizziness. With glimepiride: Q Children and adolescents, not Nasopharyngitis, hypoglycaemia. With metformin recommended. and glimepiride: Bronchitis, hypoglycaemia, D Hypocalcaemia. Pregnancy, lactation. headache. With metformin and rosiglitazone: B Severe renal impairment (avoid). Ensure Nasopharyngitis, hypoglycaemia, headache, adequate hydration. Treat disturbances of mineral fatigue, pyrexia. All combinations: Anorexia, GI metabolism first. Vit D intake recommended disorders. following inf. Ensure adequate Ca++ suppl. (at least 500mg Ca++ twice daily for min. 10 days following 6.5 THYROID HORMONES AND inf). Monitor for symptoms of hypocalcaemia. ANTITHYROID DRUGS C Caution: Drugs impacting renal function (e.g. aminoglycosides, diuretics). ELTROXIN Goldshield A Flu-like symptoms, hypocalcaemia, headache, lethargy, dyspnoea, diarrhoea, nausea, 2MO dyspepsia, bone pain, arthralgia, myalgia, pyrexia, Thyroid hormone. Levothyroxine (Na+) 25mcg, rigors, fatigue, pain, asthenia. 50mcg, 100mcg. White scored tabs. 25mcg marked with FW 41 and others marked with tab. name P & GP/sanofi aventis and strength. 25mcg-28, A1.12; 50mcg-28, A1.52; ACTONEL 2NT 100mcg-28, A1.67. Biphosphonate. Risedronate (Na+) 30mg. White S Hypothyroidism, congenital oval film-ctd tab. marked RSN and tab. strength. hypothyroidism and juvenile myxoedema. 28, A233.40. P Initially 50-100mcg daily preferably before breakfast increasing by 50mcg at 3-4 week S Paget’s disease of the bone. intervals to maintenance. Max. 100-200mcg daily. P 30mg daily for 2 months. Swallow tab. Cardiac disease: Initially, 25mcg daily or 50mcg on whole in upright position, with glass of water, at alternate days; may be increased by 25mcg at 4 least 30 mins. before first food or drink of the day week intervals. Over 50 years, initially 50mcg daily; or at least 2 hours from any other food or drink adjust dosage according to clinical response rather at other times and at least 30 mins. before than serum levels. retiring. R As per over 50 years. Q Not recommended.
headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.
180
D Hypocalcaemia, severe renal impairment. Pregnancy, lactation. B Caution: History of oesophageal disorders (e.g. stricture, achalasia), patients unable to stay in upright position for at least 30 min, active or recent oesophageal or upper GI problems, disturbance of bone and mineral metabolism, active or recent oesophageal or upper GI problems, hypocalcaemia. Risk of rare osteonecrosis of the jaw exacerbated by dental procedures and concomitant risk factors (cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene). Contains lactose. C Medications containing Ca++, magnesium, iron, alum. A Headache, GI disorders, musculoskeletal pain.
AREDIA
Novartis
2N Bisphosphonate. Pamidronate disodium 15mg, 30mg. Powder in vials and solvent (WFI) in amps. 15mg-4, A137.36; 30mg-2, A137.36; 90mg-1, A242.63. S Tumour-induced hypercalcaemia (TIH) and tumour-induced osteolysis (TIO). Paget’s disease of bone. P TIH: Total dosage is determined by patient’s initial plasma Ca++ levels. Single IV inf. of 30-60mg over 2-4 hours is adequate for mild hypercalcaemia. Severe hypercalcaemia requires 90mg. TIO: Initially single IV inf. of 30mg weekly adjusting after reassessment of the patient. Paget’s: 180mg IV inf., as 30mg once weekly for 6 weeks or initial 30mg dose followed by 60mg every other week over 3 weeks. Max. 360mg, can repeat every 6 months if required. Dilute before use. Do not give as a bolus inj. Q Not recommended. B Pregnancy. Severe renal insufficiency. Possibility of precipitating convulsions due to electrolyte changes. C Infusion solutions containing Ca++, hypocalcaemic therapy, other bisphosphonates, plicamycin. A Asymptomatic hypocalcaemia. Mild transient pyrexia. Transient lymphocytopenia. Oliguria.
6.7 PITUITARY DISORDERS
DDAVP DESMOPRESSIN
Ferring
2JN Vasopressin analogue. Desmopressin acetate 4mcg/ ml. Amp. 10 x 1ml, A134.12. S Diagnosis and treatment of cranial diabetes insipidus. Renal function testing. P Diabetes insipidus treatment: 1-4mcg IM, SC or IM once daily. Q Diabetes insipidus: doses from 0.4mcg may be used. V Diagnosis of diabetes insipidus: 2mcg SC or IM. Renal function testing, single 2mcg dose SC or IM. Limit fluid intake to a max. of 0.5L from 1 hour before until 8 hours after admin.
2MO ALSO DDAVP DESMOPRESSIN NASAL DROPS, SOLUTION Desmopressin acetate100mcg/ml. Nasal drops. 2.5ml dropper bottle, A10.85. S Diagnosis and treatment of cranial diabetes insipidus including post-hypophysectomy polyuria/polydipsia. Renal function testing. P Diabetes insipidus treatment: 10-20mcg once or twice daily. Renal function testing: A single 40mcg dose.
2
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b
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
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7.1 GENITAL
UROLOGY
INFECTIONS
Q Diabetes insipidus treatment: 5-10mcg once or twice daily. Renal function testing: A single 20mcg dose; infants, a single 10mcg dose. V Diagnosis of diabetes insipidus: A single 20mcg dose. Limit fluid intake to a max. of 0.5L from 1 hour before until 8 hours after admin. D Habitual or psychogenic polydipsia, alcohol abuse. Suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. Hyponatraemia. Syndrome of inappropriate ADH secretion (SIADH). Moderate and severe renal insufficiency. B Only use where orally admin. formulations are not feasible. Very young, elderly patients, fluid and/or electrolyte imbalance, patients at risk for increased intracranial pressure, hypertension, reduced renal function, CVD, CF. Immediately post-hypophysectomy: Adjust dose according to urinary osmolality. Avoid ingesting water while swimming. Discontinue during an episode of vomiting and/or diarrhoea. Avoid fluid overload. Severe bladder dysfunction and outlet obstruction. Pregnancy. C Indomethacin, NSAIDs, substances suspected to induce SIADH (e.g. TCAs, SSRIs, chlorpromazine, carbamazepine). A Headache, stomach pain and nausea, fluid retention/hyponatraemia with accompanying symptoms (headache, nausea, vomiting, weight gain, decreased serum Na+ and in serious cases, convulsions). Nasal drops only: Nasal congestion/ rhinitis, epistaxis.
S Short term management of bleeding oesophageal varices. P 2mg by IV bolus inj. repeated every 4-6 hours until bleeding is controlled or a period of 72 hours has elapsed. Q Not recommended. D Septic shock. Pregnancy, lactation. B Hypertension, dysrhythmias, renal dysfunction, cerebral or peripheral vascular disease, asthma, respiratory failure or coronary insufficiency. Elderly. Monitor cardiovascular system, haematology and electrolytes regularly. C b-blockers and drugs known to induce bradycardia e.g. propofol. A Paleness, increased BP, abdominal pain, nausea, diarrhoea, headache.
Pregnancy. Elderly. Immunocompromised patients (repeat treatment not recommended). Contains methyl/propylhydroxybenzoate, cetyl/stearyl alcohol. Rarely, intense local inflammatory reactions may occur. C Condoms, diaphragms. A Local skin reactions, skin colour changes, infection, headache, flu-like symptoms, myalgia, nausea, fatigue.
BYFLUC
Ergha
2MO
Triazole. Fluconazole 50mg, 150mg. Opaque caps; 50mg, light blue cap/ white body;150mg, light blue cap and body. 50mg-7, A7.54; 150mg-1, A3.19. S Vaginal candidiasis, acute or recurrent, NORDURINE Ferring candidal balanitis. 2MO P 150mg as a single dose. Vasopressin and analogues. Desmopressin (acetate) D Pregnancy (unless essential), lactation. 0.1mg, 0.2mg. White, oval, convex tab. with single B Discontinue if symptoms of liver disease develop. Rash; discontinue if develops (dermal score, engraved 0.1 or 0.2. 0.1mg-30, A19.57; 90, A58.65; 0.2mg-30, A39.13; 90, A117.39. infection), or monitor closely and discontinue if bullous lesions or erythema multiforme develop S Cranial diabetes insipidus incl. post(invasive/systemic infection). Long-term use. hypophysectomy polyuria/polydipsia, primary C Contra: Terfenadine (if ByFluc dose nocturnal enuresis in patients from 5-65 years. Symptomatic treatment of nocturia in adults up to r400mg/d), cisarpide. Caution: Coumarin-type anticoagulants, sulphonylureas, HCTZ, phenytoin, 65 years only, associated with nocturnal polyuria. rifampicin, ciclosporin, theophylline, terfenadine, R Over 65 years, contraindicated. V Diabetes insipidus: Initially 0.1mg three astemizole or other P450 substrates, zidovudine, tacrolimus, rifabutin, benzodiazepines. times daily; maintenance 0.1-0.2mg three times daily. Primary nocturnal enuresis: Initially 0.2mg at A Headache, rash, GI disorders. Hepatic bedtime increasing up to 0.4mg. Nocturia: Initially toxicity incl. rare cases of fatalities, elevated DESMOSPRAY Ferring 0.1mg at bedtime increasing up to 0.2mg and alkaline phosphatase, bilirubin, SGOTand SGPT. 2MO subsequently 0.4mg by weekly dose escalations. CANAZOLE Pinewood Fluid restriction should be observed. Vasopressin analogue. Desmopressin acetate D Habitual or psychogenic polydipsia. 100mcg/ml (10mcg/spray). Metered dose nasal 2OY History of cardiac insufficiency, hyponatraemia, spray. 6ml, A31.08. Imidazole antifungal. Clotrimazole 1%. Smooth S Diagnosis and treatment of vasopressin- conditions requiring treatment with diuretics. white cream. 20g, A4.48 (20g not GMS Moderate to severe renal insufficiency. Elderly, sensitive cranial diabetes insipidus. reimbursable); 50g, A4.00. older than 65 years. V Diabetes insipidus treatment: 1-2 sprays S Fungal skin infections due to candida, B Reduced renal function, CVD, cystic once or twice daily according to requirements. most commonly Candida albicans eg. vaginal fibrosis. Fluid and/or electrolyte imbalance. Diabetes insipidus diagnosis: 2 sprays. Limit fluid discharge and nappy rash. intake to 0.5L from 1 hour before to 8 hours after Enuresis or nocturia: Limit fluid intake from 1 P Apply thinly and evenly to affected area hour before until 8 hours after admin; interrupt if admin. twice daily for at least 1 month diarrhoea, vomiting. Avoid fluid overload. D Habitual or psychogenic polydipsia, B Treat male partner to avoid recurrence of vaginal candidiasis. Cetostearyl alcohol (local alcohol abuse. Suspected cardiac insufficiency and Contains lactose. Pregnancy. skin reactions). Pregnancy (avoid, especially first other conditions requiring treatment with diuretic C TCADs, SSRIs, chlorpromazine, carbamazepine, NSAIDs, loperamide. Food intake trimester). agents. Hyponatraemia. Syndrome of may reduce the intensity/duration of the C Latex contraceptives; use alternative inappropriate ADH secretion (SIADH). Moderate precautions for at least five days after. and severe renal insufficiency. Hypertension, CVD. antidiuretic effect at low doses. A Headache, stomach pain, nausea, Patients over the age of 65. vomiting, hyponatraemia, dizziness, dry mouth, CANESTEN COMBI Bayer HealthCare B Only use where orally admin. formulations are not feasible. Very young, elderly weight gain, in severe cases convulsions. 2Y patients, fluid and/or electrolyte imbalance, Imidazole antifungal. Clotrimazole 500mg 7.1 GENITAL INFECTIONS patients at risk for increased intracranial pressure, (pessary) plus 200mg (cream). White convex reduced renal function, CVD, CF. Avoid ingesting ALDARA Meda pessary marked BAYER on one side and MU on water while swimming. Discontinue during an reverse with vaginal applicator plus white cream. 2MO episode of vomiting and/or diarrhoea. Avoid fluid Combi (1 pessary, 10g cream), A9.36. Immunomodulator. Imiquimod 5%. Cream in overload. Severe hypanatraemia may occur. Severe S Pessary: Candidal vaginitis. Cream: single use sachets. Box of 12, A70.99. bladder dysfunction and outlet obstruction. Associated vulvitis and treatment of partner to S External genital and perianal warts Contains benzalkonium chloride (may cause prevent reinfection. (condylomata acuminata). bronchospasm). Pregnancy. P Apply 3 times per week at bedtime until P Pessary: Insert into vagina using C Indomethacin, NSAIDs, substances applicator, preferably at night. Cream: Apply to clearance of warts or for max. 16 weeks per suspected to induce SIADH (e.g. TCAs, SSRIs, episode of warts. Leave 6-10 hrs before removing vulva 2-3 times daily. For treatment of sexual chlorpromazine, carbamazepine). partner: Apply to penis 2-3 times daily for 2 by washing. A Headache, abdominal pain, nausea, weeks. Q Not recommended. nasal congestion/rhinitis, epistaxis. D Urethral, intra-vaginal, cervical, rectal or Q Not recommended. 2MO intra-anal warts. GLYPRESSIN Ferring B Caution: Autoimmune conditions, organ ALSO CANESTEN PESSARY Clotrimazole 100mg, 2N 200mg, 500mg. Pessary with vaginal applicator. transplant patients. Uncircumcised men with 100mg-6, A3.59; 200mg-3, A3.50; 500mg-1, Vasopressin analogue. Terlipressin acetate 1mg. foreskin associated warts; discontinue if local A9.87. (trade price, non-GMS) Powder and solvent for soln for inj. 5 vials, reactions occur. Avoid: Open wounds, eyes, lips A180.20. and nostrils. Do not use occlusive dressings. S Candidal and mixed candidal/
182
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
GENITAL
INFECTIONS
7.1
B Lactation. C Cisapride, terfenadine, anticoagulants, oral hypoglycaemics, phenytoin, rifampicin, benzodiazepines, cyclosporin, theophylline, tacrolimus, rifabutin. A GI disorder, headache, anaphylaxis, rash, dizziness, seizures, alopecia, exfoliative skin disorders, dyspepsia, vomiting, hepatitis, 2MO leucopenia, neutropenia, agranulocytosis, ALSO CANESTEN DUOPAK Clotrimazole 100mg CONDYLINE Nycomed thrombocytopenia, angioedema, face oedema, (pessary) plus 200mg (cream). White biconvex, pruritus, urticaria. oblong pessaries marked Bayer on one side and 2MO AD on reverse with vaginal applicator plus Cytotoxic. Podophyllotoxin 0.5%. Soln. 3.5ml (plus FAMCICLOVIR TEVA Teva smooth, white, oil-in-water type cream. Duopak (6 applicators), A15.30. pessaries, 20g cream), A5.05. 2NO S Genital warts affecting the penis or S Pessaries: Candidal vaginitis. Cream: female external genitalia. Antiviral. Famciclovir 125mg, 250mg. White to offAssociated vulvitis and treatment of partner to P Apply twice daily for 3 days directly to white, round, film-ctd tabs marked 93 on one side prevent reinfection. the warts. Repeat if necessary at weekly intervals and 8117 or 8118 resp. on reverse. 125mg-10, P Insert one pessary daily, preferably at (i.e. 4 days later) for max. 5 weeks. Max. 50 loops A19.01; 250mg-15, A 57.01. night, for six consecutive days, or 2 pessaries for per application. S First episode and acute recurrent genital three consecutive days. Apply cream 2 or 3 times Q Not recommended. herpes infections. daily. D Open wounds. Pregnancy, lactation. P First attack, 250mg three times daily for Q Not recommended. A Local irritation. 5 days. Recurrent attacks, 250mg twice daily for 5 2OY days. Start during prodromal period or asap after DALACIN CREAM Pharmacia onset of lesion. Suppression, 250mg twice daily; ALSO CANESTEN CREAM Clotrimazole 1%, 2%. Cream. 1%-20g, A3.98 (20g not GMS interrupt at intervals of 6 to 12 months to observe 2N reimbursable); 50g, A5.83. 2%-30g, A4.61. Antibacterial. Clindamycin (phosphate) 2%. Cream. possible changes in natural disease history. S Vulvitis, balanitis; treatment of partner Q Not recommended. 40g + 7 applicators, A12.42. to prevent reinfection. B Renal impairment (see SPC). S Bacterial vaginosis. P Apply 2 or 3 times daily. P 1 applicator full intravaginally at night FAMVIR Novartis V Not applicable. for 7 days. 2K W People under 15 and over 60 years, not 2 N O ALSO CANESTEN THRUSH CREAM Clotrimazole recommended. Antiviral. Famciclovir 125mg, 250mg. White round 2%. 20g, A6.44. D Lincomycin sensitivity. film-ctd tabs. marked FV on one side and strength S Candidal vulvitis. B Discontinue use if persistent diarrhoea on reverse. 125mg-10, A12.67; 250mg-15, A38.00. P Apply 2-3 times daily. or colitis appear. Renal or hepatic impairment. S First episode and acute recurrent genital Q Not applicable. C Neuromuscular blocking agents. herpes infections. B Only on medical advice: More than 2 A GI disturbances incl. pseudomembranous P First attack, 250mg three times daily for candidal infections in last 6 months, history of colitis. Jaundice and blood disorders. 5 days. Recurrent attacks, 125mg twice daily for 5 STDs, pregnancy, age under 16 or over 60 years. days. Start during prodromal period or asap after DIFLAZOLE Pinewood onset of lesion. Abnormal vaginal bleeding/discharge, vulval or vaginal ulcers, dysuria. Q Not recommended. 2MO C May damage latex contraceptives (use B Renal impairment. Triazole. Fluconazole 50mg, 150mg, 200mg. alternative precautions for five days after Green-white, yellow and white capsules resp. FLAGYL sanofi-aventis treatment). 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, A Local burning or irritation. 2MO A51.60. S Genital candidiasis (acute or recurrent Nitromidazole. Antiprotozoal-antibacterial. CANORAL Bayer HealthCare vaginal candidiasis, candidal balanitis). Metronidazole 200mg, 400mg. Off-white film-ctd. 2MO P 150mg single oral dose. Renal tab. and off-white cap. shaped film-coated tab. impairment: See section 8.2. Both marked with name and strength. 200mg-21, Azole antifungal. Fluconazole 150mg. Opaque, A1.00; 250, A11.79; 400mg-14, A1.41; 100, Q Under 16 years, not recommended light blue hard cap. (size 1) printed CAN 150. 1, A10.04. A3.29. unless no alternative. D Pregnancy, lactation. 2MO S Acute or recurrent genital candidiasis B Discontinue if liver disease, rash (candidal vaginitis, candidal balanitis). Consider ALSO FLAGYL-S ORAL SUSPENSION (superficial infection) or bullous lesions/erythema Metronidazole benzoate 200mg/5ml. 100ml, treating partners of patients. multiforme (systemic infection) occur. Exfolliative A6.17. P 1 cap. swallowed whole. cutaneous reactions, toxic epidermal necrolysis S Urogenital trichomoniasis. Non-specific Q Not recommended. vaginitis. D Pregnancy (use contraception), lactation. (AIDS patients). C Terfenadine or cisapride P Trichomoniasis: 600mg daily in divided B May occur: Abnormalities in (contraindicated). Caution: Anticoagulants, doses for 7 days or 1g twice daily for 2 days or a haematological, hepatic, renal and other single dose of 2g. Vaginitis: 400mg twice daily for biochemical function tests (particularly in AIDS and benzodiazepines, sulphonylureas, HCTZ, phenytoin, rifampicin, ciclosporin, theophylline, 7 days or a single dose of 2g. cancer patients); monitor for development of zidovudine, rifabutin, tacrolimus, other substrates Q Trichomoniasis: Over 10 years, as per more serious hepatic injury. Exfoliative cutaneous of cyt P450. adult. 7-10 years, 300mg daily in 3 divided doses. reactions (e.g. Steven-Johnson syndrome, toxic A Headache, rash, GI disorders. 3-7 years, 200mg daily in 2 divided doses. 1-3 epidermal necrolysis) may rarely occur. If rash years, 150mg daily in 3 divided doses. All for 7 develops, further fluconazole therapy not DIFLUCAN Pfizer days. Vaginitis: Over 10 years, as per adult. recommended. Anaphylaxis reported rarely. 2MO D Active or chronic severe Peripheral and Contains lactose. C Contra: Terfenadine, cisapride. Caution: Triazole. Fluconazole 150mg. Blue cap. coded FLU Central Nervous System diseases. 150 and PFIZER. 1, A3.32. B Peripheral or central neuropathy. Coumarin anticoagulants, oral sulphonylureas, S Acute or recurrent vaginal candidiasis. Leucopenia. Transient epileptiform seizures. hydrochlorothiazide, midazolam, phenytoin , Candidal balanitis. Monitor during prolonged use. Hepatic rifampicin, cyclosporin, theophylline, zidovudine, P Single dose of 150mg orally. insufficiency or encephalopathy. Alcohol. Removed rufabutin, tacrolimus, astemizole or other drugs Q Do not exceed max. adult dose. during haemodialysis. Fructose intolerance. Elderly. metabolised by cytochrome P450. D Pregnancy. Darkens urine. Pregnancy, lactation. A GI symptoms. Also reported: Dizziness, trichomonal, staphylococcal and bacteroides vaginal infections. P 1 x 500mg pessary inserted as single dose at night. Alternatively 1 x 200mg or 2 x 100mg pessaries inserted nightly for 3 nights or 100mg inserted nightly for 6 nights. Q Not applicable.
seizures, alopecia, exfoliative skin disorders, toxic epidermal necrolysis, dyspepsia, vomiting, leucopenia, thrombocytopenia, immunological anaphylaxis (incl. angioedema, face oedema, pruritus), hepatic failure, hepatitis, hepatocellular necrosis, jaundice, hypercholesterolaemia, hypertriglyceridaemia, hypokalaemia and taste perversion.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
183
7.1 GENITAL
UROLOGY
INFECTIONS
C Phenytoin, phenobarbital, anticoagulants, disulfiram, lithium, cyclosporin, 5fluorouracil, busulfan. A GI distress, furred tongue, unpleasant taste. Rash, urticaria, flushing, angioedema, CNS disturbances, headache, dizziness, confusion, hallucinations, vision and blood disorders.
C Contact should be avoided through contraceptive devices - diaphragm/sheath as rubber may be damaged by the emollient pessary base. A Rash, genital pruritus, vaginal burning sensation, vulvovaginal discomfort, dysmenorrhoea.
FLUCOL
GYNO-PEVARYL ONCE
Rowex
taste. Urticaria, angioedema, CNS disturbances, dark urine. Neuropathy, epileptiform seizures and leucopenia on long term therapy.
RELACTAGEL
KoRa
2K Vaginal pH regulator. Lactic acid 4.5% w/w, glycogen 0.1% w/w. Soft colourless viscous gel. 7 x
Janssen-Cilag 5ml single dose applicator tubes, A 7.29.
2MO
2MO
Triazole. Fluconazole 50mg, 150mg, 200mg. Hard caps. 50mg, turquoise/white; 150mg, white/white; 200mg, purple/white. 50mg-7, A12.84; 150mg-1, A5.48; 200mg-7, A51.26. S Acute and recurrent vaginal candidiasis which do not respond to local therapy. P 150mg as a single dose. Q Not applicable. D Pregnancy. B Development of abnormal liver test values (monitor closely). Proarrhythmic conditions eg. QT prolongation, cardiomyopathy, sinus bradycardia, arrhythmias. Caps. contain lactose. Lactation (use only as single 200mg dose). C Contra: Drugs known to prolong QTinterval and metabolised by CYP3A4, eg. cisapride, terfenadine, astemizole, pimozide, quinidine and halofantrine. Caution: Other substrates of CYP3A4 or CYP2C9 (sulphonyl urea, phenytoin, losartan, celecoxib, fluvastatin, anticoagulants), HCTZ, rifampicin, nevirapine, amitriptyline, didanosine, theophylline, trimetrexate, zidovudine, amphotericin B. A Skin rash, headache, GI upset, increase of AST, ALT and alkaline phosphatase.
Antifungal. Econazole nitrate 150mg pessary. Light beige pessary. 1 + applicator, A5.09. S Vaginitis due to C. albicans and other yeasts. P 1 inserted high in vagina as single dose at night.
2NO ALSO GYNO-PEVARYL 150 Econazole nitrate 150mg. White vaginal pessaries. 3, A3.67. S Fungal or yeast infections of the vagina and vulva. P 1, inserted deep into vagina; daily for 3 consecutive days. A Local mild burning or irritation.
S Management of vaginal discharge through the regulation of vaginal pH. P Prevention: 1 single tube daily for 2-3 days at bedtime after menstruation. Treatment: 1 single tube daily for 7 days at bedtime. Q Not recommended. B Avoid when trying to conceive. A Stinging pain during fungal infections of the vagina or when there are tears in the vaginal tissue.
SPORANOX
Janssen-Cilag
2MO
Azole antifungal. Itraconazole 100mg. blue/ transparent cap. and pink body, size 0. 15, A26.04. IMUNOVIR Newport Pharmaceuticals S Onychomycosis, systemic mycoses, 2NO pityriasis versicolor, dermatophytoses, oral candidosis. vulvovaginal candidosis. Immunomodulator. Inosine pranobex 500mg. P Onychomycosis, 200mg once daily for 3 White ovoid tab. 100, A42.68. S Management of patients with months or 2 pulse treatments for fingernail immunodepression suffering from viral infections infections or 3 pulse treatments for toenail incl. subacute sclerosing panencephalitis (SSPE), infections. A pulse treatment consists of 2 caps. varicella and herpes simplex (type I and II). Genital (200mg) twice daily for 7 days. Pulse treatments warts, as adjunctive therapy to podophyllin or CO2 are separated by a 3-week drug-free interval. laser. Pityriasis versicolor, 200mg once daily for 7 days. P 50mg/kg of body weight up to a Tinea corporis, tinea cruris, 100mg once daily for 2 GYNO-DAKTARIN Janssen-Cilag maximum of 4g (usually 2 tabs 3-4 times a day). weeks. Tinea pedis, tinea manuum, 100mg once 2MO SSPE: 100mg/kg of body weight up to a maximum daily for 4 weeks. Fungal keratitis, 200mg once Imidazole antifungal-antibacterial. Miconazole of 3-4g continuously with regular monitoring. 3g daily for 3 weeks. Oral candidosis, 100mg once nitrate 1200mg. Soft white vaginal cap. 1, A4.57. daily in divided doses for 28 days. daily for 2 weeks. Vulvovaginal candidosis 200mg S Treatment of vulvo-vaginal candida Q Under 1 year, not recommended; over 1 twice daily for 1 day or 200mg once daily for 3 infections in females incl. those with year, 50-100mg/kg body weight daily in four days. superinfection due to susceptible gram positive divided doses; over 12 years, as for adults. W Not recommended. bacteria. D Patients presently suffering from gout D Pregnancy-contraception must be used P 1 cap. inserted high into the vagina or elevated uric acid blood levels. during, and for one menstrual cycle after before retiring at night as a single dose. B May be administered with caution in treatment. Lactation. Q Not recommended. patients with a history of gout, hyperuricaemia, B CHF or history of: Use only if benefit 2MO hepatic dysfunction, urolithiasis or in patients with outweighs risks. CHF risk increases with total daily impaired renal function. ALSO GYNO-DAKTARIN CREAM Miconazole dose. Transient LV ejection fraction may occur. C Xanthine oxidase inhibitors, nitrate 2%. Vaginal cream. 78g with 16 Caution: Hepatic, renal impairment. Monitor liver corticosteroids, uricosuric agents. applicators, A5.75. function, patient should report signs of hepatitis; A Elevated levels of uric acid. S Treatment of vulvovaginal candidosis if occurs stop immediately. Discontinue if and superinfection due to susceptible gram neuropathy occurs. Oral solution not METRONIDE Clonmel positive bacteria. recommended for severe neutropenia. Transient or 2MO P 2 applicators (10g) for 7 days or 1 permanent hearing loss may occur. Not applicator once daily before retiring for 14 days, Antiprotozoal-antibacterial. Metronidazole 200mg. recommended: Fructose intolerance, glucoseapplied deeply into vagina. Full course of White tab. scored and coded MZL 200 on one galactose malabsorption, sucrase-isomaltase treatments must be continued although side, twin triangle logo on reverse and white tab. insufficiency. sympomatic relief may occur. scored and coded MZL 400 on one side, twin C Contraindicated: Astemizole, bepridil, Q Not recommended. triangle logo on reverse. 21, A1.62. cisapride, dofetilide, levacetylmethadol 2MO S Trichomonal infestation in both sexes. (levomethadyl), mizolastine, pimozide, quinidine, ALSO GYNO-DAKTARIN PESSARIES Miconazole P 600mg daily in divided doses or short sertindole, terfenadine, CYP3A4 metabolized nitrate 100mg. White pessary. 14, A4.39. two day course of 2g in divided doses or 2g as a HMG-CoA reductase inhibitors (e.g. atorvastatin, single dose. S Local treatment of vulvovaginal lovastatin, simvastatin), triazolam, oral midazolam, Q Under 1 year, not recommended; 1-3 candidosis infections and superinfections due to ergot alkaloids (e.g. dihydroergotamine, years, 50mg three times daily; 2-7 years, 100mg gram positive microorganisms. ergometrine, ergotamine, methylergometrine), twice daily; 7-10 years, 100mg three times daily; P 1 pessary inserted deep into vagina at eletriptan, nisoldipine. Caution: CYP3A4 10-12 years, same as adult. night or 2 nightly for seven days. Repeat for 2 metabolised calcium channel blockers (e.g. B Short high dose treatment not weeks even after symptoms disappear. dihydropyridines, verapamil), oral anticoagulants, recommended in pregnancy or lactation. Liver Q Not recommended. HIV protease inhibitors (ritonavir, indinavir, disease. D Hypersensitivity to imidzoles, incl. saquinavir), busulfan, docetaxel, trimetrexate, C Alcohol, phenobarbitone, oral vinca alkaloids, ciclosporin, tacrolimus, rapamycin miconzole. anticoagulants. Cimetidine, lithium. (sirolimus), budesonide, dexamethasone, B Absorption of antifungal may occur A GI distress, furred tongue, unpleasant fluticasone and methylprednisolone, digoxin , through denuded mucosa with possible toxicity.
184
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
URINARY
incl. initial and recurrent genital herpes. Prevention (suppression) of recurrent attacks. P Treatment: Begin treatment as early as possible. Initial attack: 500mg twice daily for 10 days. Recurrent attack: 500mg twice daily for 5 days. Prevention: Immunocompetent patients: 500mg once daily or 250mg twice daily. Immunocompromised HIV infected: 500mg twice daily. Renal impairment, see SPC. VALHERP Ergha Q Not applicable. B Caution: Severe renal impairment, 2NO elderly, liver disease. Maintain adequate Antiviral. Herpes-specific enzyme inhibitor. Valaciclovir (HCl) 500mg. Creamy, oblong film-ctd hydration. Use in genital herpes: Safer sex practices also recommended. Pregnancy, lactation. tab. 10, A18.50; 30, A55.49; 42, A77.66. S Treatment and prevention (suppression) A Mild headache. Nausea. of herpes simplex infections of skin and mucous WARTICON Stiefel membranes, incl. initial and recurrent genital 2MO herpes. P Treatment: 500mg twice daily. May be Cytotoxic. Podophyllotoxin 0.15%. Cream. 5g (plus extended to 10 days for initial episodes. For mirror), A22.15. recurrent episodes, treatment should be for 5 S Genital warts affecting external days. Begin treatment as early as possible; ideally genitalia. during the prodromal period or immediately after P Apply twice daily for 3 days. If warts 1st signs or symptoms appear for recurrent persist, 3 day treatment may be repeated weekly episodes. Suppression of recurrences : In for up to 4 weeks in total. immunocompetent patients, 500mg once daily. For Q Not recommended. immunocompromised HIV infected patients, D Open wounds. Pregnancy, lactation. 500mg twice daily. Renal impairment: See SPC. A Local irritation. B Caution: Renal impairment, elderly, GSK hepatic impairment and liver transplantation (high ZOVIRAX doses). Ensure adequate fluid intake in patients at 2 N O risk of dehydration (particularly the elderly). Use Antiviral. Aciclovir 200mg. White, round film-ctd in genital herpes: Safer sex practices also tab. marked GXCF3 on one side. 25, A16.10. recommended. Pregnancy, lactation. Contains 2NO lactose. ALSO ZOVIRAX SUSPENSION Aciclovir 200mg/5ml. C Caution at high valaciclovir doses (8g/ 125ml, A33.33. day): Ciclosporin, tacrolimus, mycophenolate S Treatment and longterm suppression of mofetil. genital herpes. Prophylaxis of genital herpes in A Nausea, headache. immunocompromised patients. P Treatment-200mg five times daily at VALOTIX Rowex four hourly intervals for 5 days. Prophylaxis and 2NO suppression-200mg four times daily at six hourly Antiviral. Herpes-specific enzyme inhibitor. intervals. See SPC. Valaciclovir (HCl) 500mg. White to off-white cap.- Q Treatment: Under 2 years, 2.5ml five shaped film-ctd tab. with 500 debossed on one times daily at four hourly intervals for 5 days. side. 10, A19.14. Over 2 years, same as adult. Prophylaxis: Under 2 S Treatment of initial and recurrent years, 2.5ml four times daily at six hourly intervals. genital Herpes simplex infections. Over 2 years, as adult. P 500mg twice daily for 10 days for the 2NO initial episode; 1g per day in 1 or 2 divided doses ALSO ZOVIRAX CREAM Aciclovir 5%. (GMS)2g, for 5 days for recurrent episodes. Initiate asap, A3.56; 10g, A17.84; 2g, A3.56; Pump pack 2g, preferably at prodromal stage or when lesions A4.89. appear. Renal impairment: See SPC. V Apply 5 times daily at 4 hourly intervals B Caution: History of renal impairment, for 5 days. elderly, hepatic impairment, liver transplantation. B Severe renal impairments. Maintain adequate hydration. Use in genital C Probenecid herpes: Safer sex practices also recommended. A Transient irritation, mild drying and Pregnancy, lactation (consider topical treatment). flaking of skin during topical use. C Caution if impaired renal function 7.2 URINARY TRACT INFECTIONS (regular monitoring recommended): Immunosuppressants, aminoglycosides, CYMALON Actavis organoplatins, iodinated contrast media, methotrexate, pentamidine, foscarnet. Caution at 2 high valaciclovir doses (8g/day): Cimetidine, Alkalising agent. Sodium citrate 2.8g, citric acid probenecid, mycophenolate mofetil. (anhydrous) 1g, Na+ bicarbonate 1.2g, sodium A Headache, nausea. carbonate 0.1g with a combined alkalinity equivalent to 4.4g sodium citrate with added VALTREX GSK sucrose and saccharin. Granules. Sachets-6, A4.50. 2NO S Relief of symptoms due to cystitis in Antiviral. Herpes-specific enzyme inhibitor. adult females only. Valaciclovir (HCl) 500mg. White tab. marked P One sachet in water 3 times daily for 2 GXCF1. Herpes simplex treatment pack-10, A25.52. days. Herpes simplex suppression pack-30, A76.54. Q Not recommended. S Treatment of Herpes simplex infections D Pregnancy, lactation. Cardiac disease, cilostazol, disopyramide, carbamazepine, buspirone, alfentanil, alprazolam, brotizolam, midazolam IV, rifabutin , ebastine, repaglinide, fentanyl, reboxetine, halofantrine, loperamide. A Hypokalemia, headache, dizziness, nausea, GI disturbances, hepatitis, jaundice, hyperbilirubinaemia, increased hepatic enzymes, rash, pruritus, oedema.
TRACT INFECTIONS
7.2
hypertension, diabetes, history of renal disease. Symptoms and signs of significant bacteriuria. Restricted salt diet. B Advised against repeated use. If symptoms persist 48 hours after treatment is completed, consult your doctor. If symptoms come back frequently, consult your doctor. Do not exceed the stated dose. Keep out of reach of children. C Not recommended: Urinary alkalinisers. Avoid lithium.
CYSTOPURIN
Roche Consumer
2 Alkalising agent. K+ citrate 3g. Powder. Sachet-6 x 3g, A4.66. S Symptomatic management of mild lower urinary tract infection. P Each sachet should be disolved in at least 200ml cold water. One sachet 3 times daily for 2 days. Q Under 6 years, not recommended; over 6 years, same as adults. D Patients with hyperaloemica or renal insufficiency. B Renal dysfunction, cardiac disease, GI inflammation.
FURADANTIN
Goldshield
2MO Nitrofuran. Nitrofurantoin 50mg, 100mg. Yellow pentagonal scored tabs. marked with tab. strength. 50mg-100, A11.33; 100mg-100, A19.10. S Urinary tract infections spontaneous or after surgery or instrumentation. P Acute UTI, 50mg four times daily for 7 days. Severe recurrent UTI, 100mg four times daily for 7 days.Long term suppression, 50-100mg once daily at bedtime. Prophylaxys, 50mg four times daily during procedure and 3 days after. Q Under 3 months, not recommended; 3 months-10 years: Acute UTI, 3mg/kg daily in 4 divided doses for 7 days with food or milk. Suppressive therapy, 1mg/kg once daily. Over 10 years, same as adult. D Anuria, oliguria, renal impairment. Pregnant patients at term. B Monitor pulmonary, neurological and hepatic function during long term therapy and in the elderly. Anaemia, diabetes, electrolyte imbalance, vit. B deficiency, debilitation. Lactation. C Magnesium trisilate, probenecid, sulphinpyrazone, quinolones. A Withdraw if symptoms of pulmonary reactions, hepatitis, haemolysis or peripheral neuropathy occur. GI upset, anorexia, allergic reactions, blood dyscrasias.
MACROBID
Goldshield
2MO Nitrofuran. Nitrofurantoin (as macrocrystals and monohydrate) 100mg. Blue/yellow modifiedrelease cap. marked Eaton BID. 14, A4.53. S Urinary tract infections, pyelitis, prophylaxis in genito-urinary surgery, long term suppressive therapy. P 1 twice daily with food or milk for 7 days. Prophylaxis, 1 twice daily for 4 days, starting on day of procedure. Long term suppression, 1 daily at bedtime. Q Under 12 years not applicable. D Anuria, oliguria, renal impairment. Pregnant patients at term. B Monitor pulmonary, neurological and
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
185
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
initial weekly dose (mcg) by dividing total weekly dose of r-HuEPO by 200. Determine initial every other week dose by dividing the total cumulative dose of r-HuEPO admin. over a 2 week period by 200. See SPC. Q Correction phase, no guidance for patients aged 1-10 years. Over 11 years; Correction phase as per adults. Maintenance; over 11 years as 7.3 RENAL AND BLADDER DISORDERS per adults. Paediatric patients 1-18 years receiving r-HuEPO 2-3 times a week can convert to once ALFU Rowex weekly Aranesp. Those receiving r-HuEPO once MACRODANTIN Goldshield 2MO weekly can convert to Aranesp once every other 2MO week. The initial weekly or once every other week Selective a1-blocker. Alfuzosin (HCl) 10mg. White, Nitrofuran. Macrocrystaline nitrofurantoin 50mg, dose (mcg/kg) can be determined by dividing the round, bevelled-edge, prolonged release tab. 100mg. Yellow/white cap and yellow cap. both total weekly dose of r-HuEPO (IU/week) by 240. 10mg-30, A21.29. marked with name and strength. 50mg-30, A3.63; S Moderate to severe functional D Poorly controlled hypertension. Patients 100mg-30, A6.23. suspected or confirmed to have neutralising symptoms of BPH. S Urinary tract infections spontaneous or P 10mg daily immediately after the same antibodies to erythropoietin. Lactation. after surgery or instrumentation. B Evaluate iron status prior and during meal each day. Tab. should be swallowed whole P Dose should be taken with food or treatment. Iron suppl. may be required. Monitor with fluid. milk. Acute UTI, 50mg four times dailly for 7 days. Q Not applicable. BP. Ischaemic heart disease, CHF, sickle cell Severe recurrent UTI, 100mg four times daily for 7 D Conditions with orthostatic hypotension. anaemia, epilepsy. Liver disease (no data). Monitor days. Long term suppression, 50-100mg once daily Hepatic insufficiency. K+ levels. PCRA (discontinue if occurs). Pregnancy. at bedtime. Prophylaxis, 50mg four times daily B Severe renal impairment (not C Caution: Cyclosporin, tacrolimus. during procedure and 3 days after. recommended). Transient postural hypotension A Headache, hypertension, thrombosis of Q Under 3 months, not recommended; 3 may develop. Caution: Hypersensitivity to other a1- vascular access, inj. site pain. months-10 years: Acute UTI, 3mg/kg daily in four blockers, patients who developed pronounced AVODART GSK divided doses for 7 days. Suppressive therapy, hypotension with other a1-blockers; acute cardiac failure. If angina pectoris recurs/worsens, 1mg/kg once daily. Over 10 years, same as adult. 2NO discontinue. Contains lactose. D Anuria, oliguria. renal impairment. Testosterone-5-a-reductase inhibitor. Dutasteride C Contra: Other a1-blockers. Caution: Pregnant patients at term. 0.5mg. Opaque, yellow, oblong soft gelatin cap. Antihypertensives, nitrates, potent CYP3A4 B Monitor pulmonary, neurological and marked GX CE2. 30, A29.69. hepatic function during long term therapy and in inhibitors. Anaesthetics (withdraw tab. 24 hrs S Moderate to severe symptoms of BPH. previously). the elderly. Anaemia, diabetes, electrolyte Reduction in risk of acute urinary retention and A Dizziness, headache, vertigo, malaise, surgery in patients with moderate to severe postural hypotension, GI disorders, asthenia. symptoms of BPH. MIMS Ireland current policy ARANESP Amgen P Use alone (1 once a day, swallowed whole) or in combination with 0.4mg tamsulosin. 5NT for drug inclusion Response can take up to 6 months. Human erythropoietin. Darbepoetin alfa 10, 15, Q Contraindicated. 20, 30, 40, 50, 60, 80, 100, 150, 300 and 500mcg. D Women, children and adolescents. Soln. for inj. in pre-filled syringe. 10mcg/0.4ml x 4, Severe hepatic impairment. The current editorial policy A97.06; 15mcg/0.375ml x 4, A145.59; 20mcg/0.5ml B Mild to moderate hepatic impairment; x 4, A194.12; 30mcg/0.3ml x 4, A291.18; 40mcg/ caution. Perform evaluations for prostate cancer in MIMS Ireland is to 0.4ml x 4, A388.24; 50mcg/0.5ml x 4, A485.30; (eg. digital rectal examination) before therapy and A582.36; 80mcg/0.5ml x 4, 60mcg/0.3ml x 4, include only drugs with periodically thereafter. PSA levels decreased by A776.48; 100mcg/0.5ml x 4, A970.60; 150mcg/ 50% after 6 months (double values for comparison 0.3ml x 4, A1455.90; 300mcg/0.6ml x 1, A727.95; Product Authorisations with normal ranges in untreated men). 500mcg/1ml x 1, A1091.93. C Caution: Potent CYP3A4 inhibitors, 5NT (PA number) or unlicensed verapamil or diltiazem. ALSO ARANESP SURECLICK Darbepoetin alfa 20, A Impotence, decreased libido, ejaculation drugs that are GMS 40, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. disorders, gynecomastia. in pre-filled pen. 20mcg/0.5ml x1, A48.53; 40mcg/ reimbursed. Consequently, 0.4ml x1, A97.06; 60mcg/0.3ml x1, A145.59; BYTRITE Helsinn Birex 80mcg/0.4ml x1, A194.12; 100mcg/0.5ml x1, all drugs that do not A242.65; 150mcg/0.3ml x1, A363.98; 300mcg/0.6ml 2 M O ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, x1, A727.95; 500mcg/1ml x1, A1091.93. belong to either of these 10mg. Opaque hard gelatin caps. Yellow, light S Anaemia associated with chronic renal orange, pink and blue cap with white bodies failure in adults and paediatric patients. categories are not listed in printed 93 and 7209, 7210, 7211, 7212 resp. P Correction phase: Initially 0.45mcg/kg by 1.25mg-28, A2.48; 2.5mg-28, A3.53; 5mg-28, SC or IV inj. once weekly, or 0.75mcg/kg SC once the present publication. A4.94; 10mg-28, A6.73. every 2 weeks if patient not on dialysis. Adjust S Non-diabetic/diabetic overt and This decision has been dose as necessary, increase by approx. 25% if Hb incipient nephropathy. Prevention of progression increase is Q1g/dL in 4 weeks or decrease by 25taken in order to of microalbuminuria to overt nephropathy. 50%, if rise in Hb is q2.5g/dL in 4 weeks. If Hb P Nephropathy: Initially, 1.25mg once q14g/dL, discontinue until Q13g/dL then restart preserve conciseness at approx. 25% below previous dose. Maintenance: daily. If tolerated, should be doubled at intervals Not on dialysis, once monthly dose equal to twice of 2-3 weeks. Max. 5mg daily. Microalbuminuria and consistency of to overt nephropathy: Initially 2.5mg once daily. If previous once every 2 week dose by SC; dialysis tolerated, double after 1 week and after another patients, if switching from once weekly to once MIMS Ireland. 3 weeks up to 10mg. Usual maintenance: 10mg every other week should initially receive dose daily. Discontinue diuretic 2-3 days prior to equivalent to twice the previous once weekly therapy; if not possible, reduce diuretic dose. dose. Patients receiving r-HuEPO 1, 2 or 3 times Q Not recommended. weekly may switch to once weekly or once every other week. If switching from r-HuEPO, calculate D History of angioneurotic oedema hepatic function during long term therapy and in the elderly. Anaemia, diabetes, electrolyte imbalance, vit. B deficiency, debilitation. Lactation. C Magnesium trisilate, probenecid, sulphinpyrazone, quinolones. A Withdraw if symptoms of pulmonary reactions, hepatitis, haemolysis or peripheral neuropathy occur. GI upset, anorexia, allergic reactions, blood dyscrasias.
186
imbalance, vit. B deficiency, debilitation. Lactation. C Magnesium trisilate, probenecid, sulphinpyrazone, quinolones. A Withdraw if symptoms of pulmonary reactions, hepatitis, haemolysis or peripheral neuropathy occur. GI upset, anorexia, allergic reactions, blood dyscrasias.
2
5
m
c
s
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d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
RENAL
relating to previous ACE inhibitor treatment. Pregnancy, lactation. Use in children. B Aortic stenosis, outflow obstruction (not recommended). Assess renal function prior to and during treatment. Impaired renal/liver function; reduce dose and monitor closely. Haemodialysis using high-flux membranes (avoid). Correct volume/salt depletion before initiating therapy. Collagen vascular disease; monitor white blood cell counts and protein levels in urine. Hyperkalaemia, angioneurotic oedema have been reported rarely. Surgery/anaesthesia. Driving or operating machines. C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness and headache, GI disturbances, cough, skin/mucosal reactions.
CALCIUM RESONIUM
Sanofi
2O Ion-exchange resin. Ca polystyrene sulphonate. Flavoured powder. 300g, A51.82. S Hyperkalaemia associated with anuria or severe oliguria. Hyperkalaemia in patients requiring acute dialysis and in patients on regular haemodialysis or on prolonged peritoneal dialysis. P Usually 15g three or four times daily; see SPC. Q 1g/kg daily in divided doses; maintenance, 0.5g/kg daily. D Hyperparathyroidism, multiple myeloma, sarcoidosis. B Monitor serum K+ and Ca++. A Hypercalcaemia. ++
CAPOTEN
BMS
2MO ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Mottled white cap. shaped scored tab. marked SQUIBB 450, mottled white quarter scored square tab. coded 452 and SQUIBB, mottled white oval tab. coded 482 and SQUIBB. 12.5mg-56, A7.99; 25mg-56, A9.10; 84, A24.72; 50mg-56, A15.52; 84, A42.12. S Treatment of diabetic nephropathy. P 75-100mg daily in divided doses. Q Not recommended. D Aortic stenosis. Renal impairment. Pregnancy, lactation. See SPC. B Initiate therapy under close supervision, continue diuretics and if appropriate, digitalis concurrently. With renal impairment, collagen vascular disease, immunosuppressant therapy or leukopenic drugs, monitor white cell count and urinary protein. Contains lactose. C K+sparing diuretics or K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, probenecid, immunosuppressants. A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria.
CARDURA
Pfizer
2MO Selective a-blocker. Doxazosin mesylate (equiv. doxazosin) 1mg, 2mg. White round and oblong biconvex tabs. marked CN1 and CN2 resp. with Pfizer logo on reverse. 2mg tab. scored. 1mg-28 (Cal/Pk), A4.93; 2mg-28, A6.57. S Adjunct in treatment of urinary outflow obstruction and symptoms associated with BPH. P Initially 1mg once daily; may be increased to 2mg, then 4mg, up to max. 8mg daily. Titration interval, 1-2 weeks. Usual recommended dose, 2-4mg once daily. Q Under 12 years, not recommended.
AND BLADDER DISORDERS
7.3
D Lactation. B Pregnancy. Renal/hepatic impairment, LV failure, elderly. Driving/using machines. Postural hypotension (warn patients), cataract surgery. Contain lactose. C Caution: PDE-5 inhibitors. A Vertigo, nausea, asthenia, oedema, fatigue, malaise, dizziness, headache, postural dizziness, somnolence, syncope, rhinitis.
1 dose in 24 hours. Renal function testing: 2 sprays in each nostril. Q Renal function testing, up to 1 year, 1 spray; 1-15 years, 1 spray in each nostril. D Habitual or psychogenic polydipsia, alcohol abuse. Suspected cardiac insufficiency and other conditions requiring treatment with diuretic agents. Hyponatraemia. Syndrome of inappropriate ADH secretion (SIADH). Moderate and severe renal insufficiency. Hypertension, CVD. CARSEM XL Teva Patients over the age of 65. B Only use where orally admin. 2MO formulations are not feasible. Very young, elderly Selective a-blocker. Doxazosin (as mesilate), 4mg. White, round biconvex film-ctd prolonged-release patients, fluid and/or electrolyte imbalance, patients at risk for increased intracranial pressure, tab. with DL bossing on one side. 28, A12.82. reduced renal function, CVD, CF. Avoid ingesting S Symptomatic treatment of BPH. water while swimming. Discontinue during an P 4mg once daily. May be increased to 8 episode of vomiting and/or diarrhoea. Avoid fluid mg once daily. overload. Severe hypanatraemia may occur. Severe Q Not recommended. bladder dysfunction and outlet obstruction. D Benign hyperplasia and concomitant Contains benzalkonium chloride (may cause congestion of upper urinary tract, chronic UTIs, bronchospasm). Pregnancy. bladder stones. Overflow bladder, anuria, C Indomethacin, NSAIDs, substances progressive renal impairment. History of oesophageal or GI obstruction, decreased GI tract suspected to induce SIADH (e.g. TCAs, SSRIs, chlorpromazine, carbamazepine). lumen diameter. Lactation. Pregnancy (unless A Headache, abdominal pain, nausea, clearly needed). nasal congestion/rhinitis, epistaxis. B Severe hepatic impairment, not recommended. Monitor for postural effects when Ferring initiating therapy; caution in hypotensive patients DESMOTABS MELT or patients with known orthostatic dysregulation. 2 M O Caution: Acute heart disease, mild-moderate Vasopressin analogue. Desmopressin (free base) hepatic impairment, Diabetic Autonomic 120mcg (as desmopressin acetate). White, round, Neuropathy, cataract surgery. May influence oral lyophilisate marked with two drop shaped plasma renin activity and urinary excretion of figures. 30, A39.13. vanillylmandelic acid. Driving/operating machinery. S Diagnosis/treatment of cranial diabetes C Not recommended: Tadalafil. Caution: insipidus incl. post-hypophysectomy polyuria/ Sildenafil, vardenafil, other antihypertensives, non- polydipsia and treatment of primary nocturnal steroidal antirheumatics, estrogens, enuresis in patients with normal ability to sympathomimetics, medicinal products which may concentrate urine. Nocturia in adults, associated influence hepatic metabolism (e.g. cimetidine). with nocturnal polyuria. A Apathia, muscle cramps, fatigue, P Diabetes insipidus: Dose range, 120mcgmalaise, headache, somnolence, accomodation 720mcg daily. Initially 60mcg sublingually three disturbances, palpitations, chest pain, giddiness, times daily. Usual maintenance dose, 60mcgdizziness, oedema, orthostatic dysregulation, 120mcg sublingually three times daily. Primary dyspnoea, rhinitis, GI disorders, frequent desire to nocturnal enuresis: Initially, 120mcg sublingually at micturate, increased micturation, delayed bedtime; may be increased up to 240mcg. ejaculation, asthenia. Duration up to 3 months. Nocturia: Initially 60mcg sublingually at bedtime; may be increased up to CYSTRIN Sanofi 120mcg and then 240mcg by weekly dose escalations. Discontinue if no effect within 4 2MO weeks. Anticholinergic-antispasmodic. Oxybutynin (HCl) R Over 65 years, contraindicated. 3mg, 5mg. Blue tabs. marked OXY3 and OXY5 Q Diabetes insipidus/primary nocturnal resp. 3mg-100, A19.01; 5mg-100, A33.78. enuresis: Over 5 years, as per adults. S Management of urinary frequency, D Habitual or psychogenic polydipsia, incontinence, nocturnal enuresis and bladder cardiac insufficiency, other conditions requiring dysfunction. treatment with diuretics, moderate and severe P 10-20mg daily in divided doses. Q Under 5 years, not recommended; over renal insufficiency (ccQ50ml/min), hyponatraemia, syndrome of inappropriate ADH secretion, patients 5 years, 5-15mg daily in divided doses. q65 years for treatment of primary nocturnal D Prostatic enlargement, GI obstruction. enuresis or nocturia. Glaucoma. Oesophageal obstruction. B Thyrotoxicosis, cardiac insufficiency, cardiac surgery, GIT pathology, neurological KEEP IN TOUCH WITH NEW disorders. THIS MONTH C Anticholinergics.
DESMOSPRAY
Ferring
2MO Vasopressin analogue. Desmopressin acetate 100mcg/ml (10mcg/spray). Metered dose nasal spray. 6ml, A31.08. S Nocturia associated with multiple sclerosis. Renal function testing. P Nocturia: 1 or 2 sprays at bedtime max.
New presentations, dosage and indication changes, reformulations and other news of interest to the GP are featured in the New This Month section at the front of MIMS.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
impaired renal function: 2mg once daily. Q Not recommended. D Urinary retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe UC, toxic megacolon. Pregnancy, lactation. B Significant bladder outflow obstruction, GI obstructive disorders, renal impairment, hepatic disease, autonomic neuropathy, hiatus hernia. Decreased gastrointestinal motility. Risk factors for QT-prolongation. Driving or using machinery. Detrusitol SR contains fructose. C Not recommended: Potent CYP3A4 inhibitors. Caution: Other drugs with antimuscarinic properties, muscarinic cholinergic receptor agonists, prokinetics. A Dizziness, somnolence, dry eyes, DETRUNORM XL Ferring abnormal vision, vertigo, palpitations, GI disorders, dry skin, dysuria, urinary retention, fatigue, 2MO headache, chest pain, peripheral oedema. Spasmolytic/anticholinergic. Propiverine HCI (equivalent to 27.28mg propiverine) 30mg. Orange Detrusitol only: Bronchitis, paresthesia, increased weight. Detrusitol SR only: Sinusitis. and white modified-release hard cap., containing white pellets. 28, A34.94. DITROPAN Sanofi S Urinary incontinence and/or increased 2MO urinary frequency and urgency as may occur in patients with overactive bladder. Antispasmodic-anticholinergic. Oxybutynin (HCl) P One cap. once a day, swallowed whole. 2.5mg, 5mg. Pale blue oval tab., pale blue tab. Q Not recommended. Both marked DITROPAN one side, scored and D Obstruction of the bowel. Significant marked S&N 2.5 or S&N 5 on reverse resp. 2.5mgdegree of bladder outflow obstruction where 84, A14.15; 5mg-84, A27.76. urinary retention may be anticipated. Myasthenia 2 M O gravis, intestinal atony, severe UC, toxic ALSO DITROPAN ELIXIR Oxybutynin (HCl) 2.5mg/ megacolon, uncontrolled angle closure glaucoma, 5ml. 150ml, A6.35. moderate or severe hepatic impairment, S Urinary incontinence, frequency and tachyarrhythmias. Pregnancy, lactation. urgency in patients with an unstable bladder. B Caution: Autonomic neuropathy, severe Neurogenic bladder disorders causing detrusor renal impairment, moderate or severe hepatic hyper-reflexia in conditions such as multiple impairment. May aggravate severe CHF, prostatic sclerosis and spina bifida. Children over 5 years, hypertrophy, hiatus hernia with reflux neurogenic bladder disorders and voiding oesophagitis, cardiac arrhythmia, tachycardia. symptoms due to detrusor instability. Noctural Induces mydriasis. May induce or precipitate acute enuresis. Vesicoureteric reflux. angle-closure glaucoma. Exclude pollakiuria and P 5mg two or three times daily, adjusting nocturia due to renal disease or CHF as well as according to response. Max. 5mg four times daily. organic bladder diseases before treatment. R Frail patients, max. 10mg daily in Contains lactose. divided doses. C TCAs, tranquillisers, systemic Q Over 5 years, 10mg daily in divided anticholinergics, amantadine, neuroleptics and bdoses. Under 5 years, not recommended. adrenoceptor agonists, cholinergics, isoniazid. D Bowel obstruction, significant bladder Possibly metoclopramide, other CYP3A4 substrates outflow obstruction. Intestinal atony, severe and CYP3A4 inhibitors. ulcerative colitis or toxic megacolon, myasthenia A Dry mouth, accommodation abnormal, gravis, glaucoma. Hyperpyrexia and hiatus hernia. accommodation disturbances, vision abnormal, B Autonomic neuropathy, hepatic or renal fatigue, headache, abdominal pain, dyspepsia, disease. Pregnancy, lactation. Alertness may be constipation. impaired. C Anticholinergics, phenothiazines, DETRUSITOL Pfizer amantadine, haloperidol, L-dopa, digitalis, tricyclic antidepressants. 2MO A Dry mouth, blurred vision, facial Anticholinergic. Tolterodine tartrate 1mg, 2mg flushing, weakness, drowsiness, dizziness, nausea, White film-ctd tabs. marked TO or DT. 1mg-56, constipation, tachycardia, palpitations. A35.97. 2mg-56, A39.98. S Treatment of unstable bladder with DORALESE Chemidex symptoms of urgency, frequency or urge 2MO incontinence. P 2mg twice daily. Impaired liver function/ Selective a1 blocker. Indoramin 20mg. Yellow severely impaired renal function: 1mg twice daily. triangular film-ctd ’Tiltab’ tab. 60 (4 x 15), A9.97. If troublesome side effects occur dose may be S Urinary obstruction due to benign reduced from 2mg to 1mg twice daily. Re-evaluate prostatic hypertrophy particularly in patients in after 2-3 months. whom surgery is contraindicated or delayed. Q Not recommended. P 1 twice daily, increasing by 1 daily at 2MO fortnightly intervals; max. 5 daily in divided doses. ALSO DETRUSITOL SR Tolterodine tartrate 2mg, R 1 at night. 4mg. Blue/green cap. and blue cap. resp. Both Q Not applicable. prolonged release caps. marked with symbol and 2 D Cardiac failure. or 4 in white. 2mg-28, A38.32; 4mg-28, A39.97. B If drowsiness occurs, avoid driving or operating machinery and CNS depressants. Hepatic P 4mg once daily. Impaired liver/severely
B Reduced renal function, CVD, cystic fibrosis, severe bladder dysfunction, outlet obstruction. Signs of water retention/ hyponatraemia (interrupt treatment). Nocturnal enuresis or nocturia: Limit fluid intake to min. from 1 hr before until 8 hrs after admin; discontinue if diarrhoea, vomiting until fluid balance normal. Systemic infections, fever, gastroenteritis (interrupt treatment). Pregnancy. C Caution: TCAs, SSRIs, chlorpromazine, carbamazepine, NSAIDs, loperamide. A Headache, stomach pain, nausea, hyponatraemia, dizziness, dry mouth. Long-term treament: Peripheral oedema, micturition frequency, weight increase.
188
or renal insufficiency, Parkinson’s disease, epilepsy or history of seizures. History of depression. Control incipient cardiac failure before treatment. C MAOIs, antihypertensives (incl. thiazide diuretics, b-blockers, vasodilators). Combination with other protein-bound drugs. A Initially drowsiness or sedation. Less commonly dry mouth, nasal congestion, weight gain, dizziness, retrograde ejaculation, depression, sleep disturbances, vivid dreams.
DOXANE XL
Rowex
2MO Selective a-blocker. Doxazosin (as mesilate) 4mg. Prolonged release tab. White, round, biconvex tab. embossed DL. 28, A12.66. S Symptomatic treatment of BPH. P 4mg once daily. May be increased to 8mg once daily if necessary. Q Not recommended. D Benign hyperplasia and concomitant congestion of the upper urinary tract, chronic UTIs or bladder stones. Overflow bladder, anuria or progressive renal insufficiency. History of oesophageal or GI obstruction or decreased lumen diameter of the GI tract or patients at increased risk for such obstruction. Pregnancy (only if benefit outweighs risk), lactation. B Not considered appropriate as first line treatment in hypertension. Monitor on initiation (risk of postural effects). Caution: Acute heart disease; minor/moderate hepatic impairment, diabetic autonomic neuropathy. Severe hepatic impairment, not recommended. Driving/ using machines. C Caution: NSAIDs, oestrogens, sympathomimetics, PDE-5 inhibitors. A Apathia, muscle cramps, fatigue, malaise, headache, somnolence, accommodation disturbances, palpitations, chest pain, giddiness, dizziness, oedema, orthostatic dysregulation, dyspnoea, rhinitis, constipation, dyspepsia, increased micturation (or desire to), delayed ejaculation, asthenia.
EPREX
Janssen-Cilag
5NT Erythropoietin. Epoetin alfa. Range of 1-6 thousand IU, 8000 IU, 10000 IU as well as 40000 IU human recombinant erythropoietin. (r-HuEPO). Soln. in pre-filled syringe. 1000 IU/0.5ml-6x0.5ml, A72.79; 2000 IU/0.5ml-6x0.5ml, A145.59; 3000 IU/ 0.3ml-6x0.3ml, A218.38; 4000 IU/0.4ml-6x0.4ml, A291.18; 5000 IU/0.5ml-6x0.5ml, A363.97; 6000 IU/ 0.6ml-6x0.6ml, A436.76; 8000 IU/0.8ml-6x0.8ml, A582.35; 10,000 IU/1ml-6x1.0ml, A727.94; 40,000 IU/ml-6x1ml, price on request. S Treatment of symptomatic anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, preexisting anaemias at the start of chemotherapy). To increase yield of autologous blood. To reduce exposure to allogeneic blood transfusions prior to major elective orthopaedic surgery with high risk
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
RENAL
of transfusion complications. P Haemodialysis: Initially 50 IU/kg three times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg three times per week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance, recommended total weekly dose, 75-300 IU/kg. Peritoneal dialysis: 50 IU/kg twice weekly by IV inj. Increase if necessary by 25 IU/kg twice weekly every 4 weeks to achieve a Hb 1012g/dL. Maintenance, 25-50 IU/kg per week in two equal doses. Non-dialysis: Initially 50 IU/kg 3 times per week by IV inj. Increase if necessary by 25 IU/ kg 3 times/week every 4 weeks to achieve a Hb 10-12g/dL. Maintenance 17-33 IU/kg/week in 3 divided doses; max. 200 IU/kg 3 times/week. May admin. by SC inj. where IV not readily available. Chemotherapy, autologous predonation and major elective orthopaedic surgery: See SPC. Q Haemodialysis: Initially 50 IU/kg 3 times per week by IV inj. following dialysis. Increase if necessary by 25 IU/kg 3 times per week every 4 weeks to achieve a Hb 9.5-11g/dL. Maintenance, under 10kg, 75-150 IU/kg; 10-30kg, 60-150 IU/kg; over 30kg, 30-100 IU/kg. All 3 times per week. D Uncontrolled hypertension. Severe coronary, peripheral arterial, carotid or cerebral vascular disease in patients scheduled for major elective orthopaedic surgery and not participating in autologous blood donation. Patients unable to receive antithrombotic prophylaxis. Patients who have developed Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. B Caution: Hypertension, ischaemic vascular disease, thrombocytosis, history of epilepsy, liver failure, increased risk of thrombotic vascular events in cancer patients, porphyria. Correct other causes of anaemia; iron suppl. may be required. Monitor BP, Hb, blood count, serum electrolytes. Limit Hb rise to Q2g/dL per month. Chronic renal failure patients treated by SC route: Monitor regularly for loss of efficacy. Theoretically could stimulate malignant growth. Pregnancy, lactation. C Cyclosporin. A Hypertension, headache, deep vein thrombosis, pulmonary embolism, flu-like symptoms, seizures, rash, palpebral oedema, diarrhoea, vomiting, arthralgia, pyrexia, shunt thromboses. Rarely, PRCA, withdraw and do not transfer to other erythropoietins.
and solvent for soln. for inf. 1.5mg/ml-3, A228.71. 7.5mg/5ml-1, A375.24. S Treatment and prophylaxis of acute hyperuricaemia, in order to prevent acute renal failure, in patients with haematological malignancy with high tumour burden and at risk of a rapid tumour lysis or shrinkage at initiation of chemotherapy. P 0.2mg/kg once daily 30 min. IV inf. in 50ml of a 9mg/ml sodium chloride soln. for 5-7 days starting immediately prior to and during the initiation of chemotherapy. Inf. through a different line than that used for inf. of chemotherapeutic agent. Q Not recommended. D G6PD deficiency and other cellular metabolic disorders known to cause haemolytic anaemia. Pregnancy, lactation. B Monitor for skin allergic reactions or bronchospasm. History of atopic allergies. Hyperphosphataemia, hyperkalaemia, hypocalcaemia. Insufficient data to recommend multiple treatment courses. A Fever, nausea, vomiting, diarrhoea, headache, haemolytic anaemia, allergic reactions.
AND BLADDER DISORDERS
7.3
A Skin rash, impotence, reduced libido, reduced volume of ejaculate, breast tenderness/ breast enlargement, ejaculation disorder.
FINOCAR
Pinewood
2NO
Selective 5-a reductase inhibitor. Finasteride 5mg. Light blue spherical biconvex film-coated tablet. 28, A22.77. S Treatment and control of BPH in patients with an enlarged prostate (q40ml) to cause regression of the enlarged prostate, improve urinary flow and improve associated symptoms and to reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. P One tab. swallowed whole daily for at least 6 months. D Women and children. B Exclude prostate cancer by digital rectal examination and, if necessary, determination of PSA, prior to and during therapy. Exclude obstruction due to trilobular growth pattern of the prostate before initiating treatment. Monitor at risk of obstructive uropathy. Impaired FINASTERIDE RANBAXY Ranbaxy patients hepatic function. Pregnant women should not 2NO handle crushed or broken tablets. Contains Selective 5 a reductase inhibitor. Finasteride 5mg. lactose. White, round, biconvex, film-ctd tab., diameter A Impotence, reduced libido, reduced 7mm, embossed F and 5 on one side. 28, A17.88. volume of ejaculate, breast tenderness/breast S Treatment and control of BPH to cause enlargement. regression of the enlarged prostate, improve FINTEX Helsinn Birex urinary flow and improve symptoms associated with BPH; to reduce incidence of acute urinary 2NO retention and need for surgery including Selective 5-a reductase inhibitor. Finasteride 5mg. transurethral resection of the prostate (TURP) and Blue, 7mm, round biconvex, film-ctd tab. marked prostatectomy. Only for patients with an enlarged F5 on one side. 28, A9.94. prostate (prostate volume q 40ml). S Treatment and control of benign P 5mg tablet daily, swallowed whole and prostatic hyperplasia (BPH) and prevention of not divided or crushed. Treatment for at least 6 urologic events to reduce the risk of acute urinary months may be necessary. retention, reduce the risk of surgery including D Women or children. transurethral resection of the prostate (TURP) and B Caution: Impaired hepatic function. prostatectomy. Carefully monitor patients for obstructive P 1 tab. daily for at least 6 months. uropathy (patients with large residual urine Q Contraindicated. volume and/or severely diminished urinary flow). D Women and children. Exclude obstruction due to trilobular growth B Carefully monitor patients for pattern of the prostate before initiating. Exclude obstructive uropathy. Exclude prostate cancer by prostate cancer by digital rectal examination and, digital rectal examination and, if necessary, if necessary, determination of PSA, prior to and FASTURTEC Sanofi during therapy. Women who are pregnant or may determination of PSA, prior to and during therapy. Contains lactose. 2JN become pregnant should not handle crushed or A Impotence, decreased libido, ejaculation broken tablets. Contains lactose. Uricolytic agent. Rasburicase 1.5mg/ml. Powder disorders, decreased volume of ejaculate, breast tenderness, breast enlargement and rash.
FINTRID
EDITORIAL INFORMATION The information published in the editorial listing in MIMS Ireland is based upon details supplied by the manufacturers. The Index lists preparations which are available on prescription in general practice.
Rowex
2NO Selective 5-a reductase inhibitor. Finasteride 5mg. Blue, round, biconvex, film-ctd tab. 28, A18.65. S Treatment and control of BPH to cause regression of the enlarged prostate, improve urinary flow and symptoms associated with BPH, reduce the incidence of acute urinary retention and reduce need for surgery. P 5mg daily; swallowed whole. Treatment for up to 6 months may be necessary. Q Contraindicated. D Use in women and children. B Monitor patients at risk of obstructive uropathy. Exclude obstruction due to trilobular growth pattern of the prostate. Hepatic insufficiency. Contains lactose. Exclude prostate cancer by digital rectal examination and, if
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
189
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
serum phosphate levels. P Chew tab. with or just after food, divided between meals. Initial daily dose based on serum phosphate concentration (i.e. 1.8 -2.4mmol/ FLOLAN GSK L 750mg; 2.4-2.9mmol/L 1500mg; q2.9mmol/ L 2250mg). Titrate every 2-3 weeks until 2NO acceptable serum phosphate level reached. Prostaglandin. Epoprostenol 500mcg (as Na+ salt). Q Under 18 years, not recommended. Powder and solvent for soln for inf. 1 each, D Hypophosphataemia. Pregnancy, A122.69. lactation. S In renal dialysis when use of heparin B Monitoring of liver function tests carries a high risk of causing or exacerbating recommended. Renal insufficiency (monitor serum bleeding or when heparin is otherwise Ca+ levels). Acute peptic ulcer, UC, Crohnâ&#x20AC;&#x2122;s disease contraindicated. or bowel obstruction. Long-term admin. (q2 yrs). P Prior to dialysis, 4ng/kg/min IV for 15 mins. During dialysis, 4ng/kg/min into arterial inlet Discontinue if hypophosphataemia develops. May cause abdominal x-rays to have a radio-opaque of the dialyser. D CHF arising from severe LV dysfunction. appearance. Driving/using machines. C 2 hrs apart: Drugs interacting with Do not use chronically in patients who develop antacids (e.g. chloroquine, hydroxychloroquine, pulmonary oedema during dose-ranging. ketoconazole), tetracycline, doxycycline, floxacins. B Monitor BP and heart rate during admin. Pregnancy and lactation (only if essential). A GI disorders, hypocalcaemia. C Caution: Anticoagulants, other GLYPRESSIN Ferring vasodilators, NSAIDs. 2N A Facial flushing, headache, GI disorders, jaw pain, dry mouth, lassitude, inf. site reaction, Vasopressin analogue. Terlipressin acetate 1mg. chest pain, decreased platelet count, tachycardia, Powder and solvent for soln for inj. 5 vials, A180.20. bradycardia, anxiety, agitation. S Emergency treatment of type 1 FLOTROS Galen hepatorenal syndrome, as defined by IAC (International Ascites Club). 2O P 3-4mg every 24 hours as 3 or 4 admin. Anticholinergic. Trospium Cl 20mg. Round, white Continue until serum creatinine falls below film-ctd tab. 60, A19.72 130mcmol/litre or by r 30%. If no reduction in S Urge incontinence and/or increased serum creatinine after 3 days stop treatment. urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or Duration: Approx. 10 days. Q Not recommended. neurologic detrusor overactivity). D Septic shock. Pregnancy, lactation. P 1 tab. twice a day. Severe kidney B Hypertension, dysrhythmias, renal dysfunction: 1 tab. once a day or every second dysfunction, cerebral or peripheral vascular day. Reassess every 3-6 months. disease, asthma, respiratory failure or coronary Q Under 12 years, not recommended. D Urinary retention, severe GI dysfunctions insufficiency. Elderly. Monitor cardiovascular system, haematology and electrolytes regularly. (incl. toxic megacolon, severe colitis ulcerosa), Prior to therapy confirm patient has acute myasthenia gravis, narrow-angle glaucoma, functional renal failure (and that it is unresponsive tachyarrhythmias. to a suitable plasma expansion therapy). B Exclude organic causes of frequency, C b-blockers and drugs known to induce urgency and urge incontinence (heart or kidney diseases, polydipsia, urinary organs infections and bradycardia e.g. propofol. A Paleness, increased BP, abdominal pain, tumours) before starting treatment. Caution: GI nausea, diarrhoea, headache. tract obstructions (e.g. pyloric stenosis), urinary obstructions (with risk of residual urine HYPOVASE Pfizer formation), autonomous neuropathy, hiatus 2MO hernia, oesophagitis, hyperthyroidism, coronary diseases, CHF, slight to moderate liver Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. insufficiency, renal insufficiency. Pregnancy, White tab. marked Pfizer and white tab. scored lactation. Contains lactose. and marked M6, resp. B.D. Starter pack (8 x C Anticholinergics , b-sympathomimetics, 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17;. prokinetics (e.g. metoclopramide, cisapride). Avoid 1mg-56, A4.07. medications containing guar, cholestyramine and S BPH. colestipol. P Initially 500mcg twice daily for 3-7 days A GI disorders. initial dose admin. in the evening; maintenance 2mg twice daily. FOZNOL Shire Q Not recommended. D Sensitivity other quinazolines. 2MO B Pregnancy, lactation. Initial low dose Phosphate binder. Lanthanum (as carbonate and gradual titration is recommended, monitor hydrate) 250mg, 500mg, 750mg, 1000mg. White, BP. round, beveled-edge flat tabs. marked S405/ strength. 250mg-90, A120.60; 500mg-90, A161.01; C Other antihypertensives. Caution: PDE-5 inhibitors. 750mg-90, A214.68; 1000mg-90, A227.55. S Hyperphosphataemia: In chronic renal HYTRIN Amdipharm failure patients on haemodialysis or continuous 2MO ambulatory peritoneal dialysis and in adults with chronic kidney disease, not on dialysis, with serum Selective a1 blocker. Terazosin (HCl dihydrate) 1mg, 2mg, 5mg, 10mg. White, yellow, brown and phosphate levels r1.78 mmol/L in whom a low blue tabs. resp. marked with logo and triangular phosphate diet alone is insufficient to control necessary, determination of PSA. A Impotence, reduced libido, reduced volume of ejaculation.
190
symbols. Starter pack-7 x 1mg plus 7 x 2mg, A8.45; 2mg-28, A15.35; 5mg-28, A20.73; 10mg28, A29.16. S BPH. P Initially 1mg at bedtime increasing to 510mg once daily at bedtime. Q Not recommended. B History of syncope. Hepatic impairment. C Antihypertensives, diuretics. A Syncope with initial dose. Dizziness, postural hypotension, lassitude, peripheral oedema.
INSTILLAGEL
Farco
2O Local anaesthetic/disinfectant. Lignocaine (HCl) 2%, chlorhexidine gluconate 0.05%, methyl hydroxybenzoate 0.06%, propyl hydroxybenzoate 0.025%. Gel in disposable syringe. 6ml, 98c; 11ml, A1.23. S Local anaesthesia disinfection and instrument lubrication in urethral catheterisation and cystoscopy. V Instil 6-11ml into the urethra after external disinfection; see SPC. B Severe local haemorrhage.
KENTERA
Recordati
2MO Antispasmodic-anticholinergic. Oxybutynin 36mg releasing 3.9mg / 24 hrs. Transdermal patch. 8, A37.10. S Urge incontinence and/or increased urinary frequency and urgency as may occur in patients with unstable bladder. P 1 applied twice weekly to dry, intact skin on abdomen, hip, or buttock. Avoid reapplication to same site within 7 days. Q Children or adolescents, not recommended. D Urinary retention, severe GI condition, myasthenia gravis, narrow-angle glaucoma and in patients at risk for these conditions. Pregnancy (unless clearly necessary), lactation. B Caution: Hepatic or renal impairment, bladder outflow obstruction, GI obstructive disorders, UC, intestinal atony, hiatus hernia/GI reflux, autonomic neuropathy, cognitive impairment or Parkinsonâ&#x20AC;&#x2122;s disease. Elderly. Driving/ operating machines. C Caution: CYP3A4 substrates or inhibitors, other anticholinergics, antihistamines, antipsychotics, quinidine, TCAs, atropine, prokinetic therapies, bisphosphonates. A Appl. site reactions, UTIs, vision abnormalities, dizziness, somnolence, headache, dry mouth, GI disorders.
LOAVEL
sanofi-aventis
2MO ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.57; 2.5mg-28, A3.65; 5mg-28, A5.08; 10mg-28, A6.88. S Non diabetic and diabetic overt/ incipient nephropathy. Prevention of progression of microalbuminuria to overt nephropathy. P Non diabetic and diabetic overt/ incipient nephropathy: Initially 1.25mg once daily titrate according to response; max. 5mg once daily. Discontinue diuretic at least 2-3 days. Hepatic impairment: Max. 2.5mg once daily. Prevention of progression of microalbuminuria to overt nephropathy: Initially 2.5mg once daily
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
RENAL
increasing gradually to double the dose after 1 week and after another 3 weeks to 10mg usual maintenance dose. R Consider initial dose of 1.25mg daily. Dose titrated according to need for BP control. Q Not recommended. D History of angiooedema. Aortic stenosis or outflow obstruction. Renal artery stenosis, hypotensive or haemodynamically unstable states. Pregnancy, lactation. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: Reduce dose and assess renal function prior to and during treatment. Caution: Patients with hyper stimulated angiotension system. Electrolyte monitoring recommended. Haemodialysis (avoid in patients dialysed with high flux membranes). Malignant hypertension: Initiate in hospital under close supervision. Symotomatic hypotension, agranulocytosis/bone marrow depression, hyperkalaemia have been reported rarely. Caution: Surgery and during anaesthesia. C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, sympathomimetics, antidiabetic agents, NSAIDs. A Nausea, dizziness, headache, dry tickling cough.
LYRINEL XL
AND BLADDER DISORDERS
7.3
nasopharyngitis, URTIs,, bronchitis,, sinusitis, insomnia, depression nervousness, confusional state, somnolence, headache, dizziness, dysgeusia, blurred vision, dry eye, keratoconjunctivitis sicca, palpitations, hypertension, nasal dryness, mucosal dryness, cough, pharyngo-laryngeal pain, dry throat, GI disorders, dry skin, pruritus, pain in extremity, back pain, arthralgia, micturition disorder, residual urine volume, urinary retention, dysuria, urinary hesitation, asthenia, peripheral oedema, fatigue, chest pain, BP increased.
patients with parathyroid carcinoma. P HPT: Initially, 30mg once per day taken whole with food or shortly after meal. Titrate every 2-4 weeks to max. 180mg once daily to achieve target PTH of 150-300pg/ml (see SPC). Parathyroid carcinoma: Initially, 30mg twice per day. Titrate every 2-4 weeks to 60mg twice daily, 90mg twice daily, and 90mg three or four times daily to achieve Ca++R UPN. Max. 90mg four times daily. Q Under 18 years, not recommended. B History of seizure disorder, moderate to MIMPARA Amgen severe hepatic impairment. Do not initiate if serum Ca++ below the lower limit of the normal 2NT range. Monitor for hypocalcaemia. May cause Anti-parathyroid agent. Cinacalcet 30mg, 60mg, isolated cases of hypotension and/or worsening 90mg. Light green, oval, film-ctd tabs. marked HF. Pregnancy, lactation (only if benefit outweighs AMGEN on one side and 30, 60 and 90 resp. on risk). the other. 30mg-28, A214.11; 60mg-28, A395.27; C Caution: Strong inhibitors or inducers of 90mg-28, A592.91. S Secondary hyperparathyroidism (HPT) in CYP3A4 and/or CYP1A2, substrates of CYP2D6 with narrow therapeutic index, smoking. patients with end-stage renal disease on maintenance dialysis therapy, as part of a regimen A Nausea, vomiting, anorexia, dizziness, paraesthesia, rash, myalgia, asthenia, with phosphate binders and vit. D sterols as appropriate. Reduction of hypercalcaemia in hypocalcaemia, reduced testosterone levels.
Janssen-Cilag
2MO Anticholinergic-antispasmodic. Oxybutynin (HCl) 5mg, 10mg. Round yellow or pink prolongedrelease tabs. marked 5 XL or 10 XL resp. 5mg-30, A18.42; 10mg-30, A36.84. S Adults and elerly: Urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with unstable bladder. Children over 6 years: Symptomatic treatment of detrusor hyperreflexia secondary to a neurogenic condition. P Initially, 5mg once daily swallowed whole with liquid. After one week, may be increased to 10mg once daily, with subsequent increments or decrements of 5mg/day, with min. one-week interval between dose changes. Max. 20mg daily. Q 5mg once daily, increased in 5mg increments up to max. of 15mg once daily. D Narrow-angle glaucoma or shallow anterior chamber, myasthenia gravis, urinary retention, GI obstructive disorder, paralytic ileus, intestinal atony, severe ulcerative colitis, toxic megacolon, urinary frequency and nocturia due to heart or renal failure. Porphyria. Lactation. B Monitor for anticholinergic CNS effects (particularly after beginning treatment or dose increases). Caution: Frail elderly, GI mobility disorders, hepatic or renal impairment, bladder outflow obstruction, GORD and/or patients taking drugs that can cause or exacerbate esophagitis, pre-existing dementia treated with cholinesterase inhibitors, UTI. May aggravate hyperthyroidism, CHF, cardiac arrhythmia, tachycardia, hypertension, prostatic hypertrophy. May lead to decreased salivary secretions. Monitor visual acuity and intraocular pressure; advise patients to seek advice immediately in case of sudden loss of visual acuity. Pregnancy (only if benefit outweighs risk). Driving/ using machines. Contains lactose. C Caution: Drugs with anticholinergic activity, such as amantadine, levodopa, antihistamines, antipsychotics, quinidine, TCAs, atropine and related compounds. Potent CYP3A4 inhibitors. A UTIs, cystitis, pharyngitis, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
191
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
MIRCERA
Roche
5NT Continuous erythropoietin receptor activator. Methoxy polyethylene glycol-epoetin beta 30, 50, 75, 100, 120, 150, 200 and 250mcg in 0.3ml. Soln for inj. in pre-filled syringe. Pack of 1, price on request. S Symptomatic anaemia associated with chronic kidney disease. P Erythropoiesis Stimulating Agent (ESA)naive patients: 0.6mcg/kg once every two weeks until Hb q10g/dL by single inj. IV or SC. Increase dose by approx. 25% if Hb rise Q 1g/dL/month. Continue 25% increase at monthly intervals until Hb target is reached ; then switch to monthly dosing at double the fortnightly dose. Converting from current ESA: Start as single injection once monthly at next scheduled dose (see SPC). Consider 25% monthly dose increment if required to maintain target. All patients: Reduce dose by 25% if Hb rise q 2g/dL/month or approaching 12g/dl. If Hb continues to rise, interrupt therapy until Hb levels decrease and restart at dose 25% lower. Q Under 18 years, not recommended. D Uncontrolled hypertension. B Monitor Hb every two weeks until stabilised and periodically thereafter. Evaluate iron status prior to and during treatment; suppl. iron if serum ferritin Q 100mcg/L or transferrin saturation Q 20%. Also correct folic acid or vitamin B12 deficiency. Pure Red Cell Aplasia reported with other ESAs; donâ&#x20AC;&#x2122;t switch to Mircera patients with antibodies to erythropoietin. BP should be controlled before and during treatment (if not reduce dose or discontinue). Caution: Seizures, haemoglobinopathies, bleeding or recent history of bleeding requiring transfusions, platelet levels q500x109/l. Not indicated for cancer patients. Hb in excess associated with life threatening cardiovascular complications. Pregnancy. Lactation (assess risk benefit). A Hypertension.
K+suppl., K+sparing diuretics, lipid solutions, NSAIDs, doxycycline, sulphadiazine, IV sulphadimidine, IV trimethoprim, diclofenac, nifedipine, grapefruit juice. A Renal and hepatic dysfunction, hypertension, tremor, GI disturbances, hypertrichosis, gingival hypertrophy, malignancies, lymphoproliferative disorders, burning sensations (feet and hands), fatigue, muscle weakness or cramp, myopathy. Rarely hyperkalaemia, hyperuricaemia, hypomagnesaemia, hypercholesterolaemia, oedema, convulsions, headache, rash, mild anaemia, haemolytic uraemic syndrome, weight gain, pancreatitis, colitis, paraesthesia, neuropathy, confusion, dysmenorrhoea, amenorrhoea, gynaecomastia, encephalopathy.
NEORECORMON
Fluid restriction should be observed. D Habitual or psychogenic polydipsia. History of cardiac insufficiency, hyponatraemia, conditions requiring treatment with diuretics. Moderate to severe renal insufficiency. Elderly, older than 65 years. B Reduced renal function, CVD, cystic fibrosis. Fluid and/or electrolyte imbalance. Enuresis or nocturia: Limit fluid intake from 1 hour before until 8 hours after admin; interrupt if diarrhoea, vomiting. Avoid fluid overload. Contains lactose. Pregnancy. C TCADs, SSRIs, chlorpromazine, carbamazepine, NSAIDs, loperamide. Food intake may reduce the intensity/duration of the antidiuretic effect at low doses. A Headache, stomach pain, nausea, vomiting, hyponatraemia, dizziness, dry mouth, Roche weight gain, in severe cases convulsions.
5NT
Recombinant human erythropoietin. Epoetin beta 500 IU, 2000 IU, 3000 IU, 4000 IU, 5000 IU, 6000 IU, 10000 IU, 20000 IU, 30000 IU. Pre-filled syringes: 500 IU-6, A36.40; 2000 IU-6, A145.59; 3000 IU-6, A218.38; 4000 IU-6, A291.18; 5000 IU-6, A363.97; 6000 IU-6, A436.76; 10000 IU-6, A727.94; 20000 IU-6, A1455.80; 30000 IU-4, A1237.48. S Anaemia associated with chronic renal failure in dialysis or pre-dialysis patients. V SC initially 3 x 20 IU/kg body weight per week. Increasing every 4 weeks by 3 x 20 IU/kg per week if the increase in PCV is Q0.5% per week. Weekly dose can be given as one inj. or in divided doses. IV admin. initially 3 x 40 IU/kg per week. Increasing after 4 weeks to 3 x 80 IU/kg per week and if further increments are required by 3 x 20 IU/kg per week at monthly intervals. Max. 720 IU/kg per week. Maintenance, initially reduce to half previous dose, then adjust to individual requirements at 1 or 2 week intervals. Children, follow recommended dosing schedule. D Uncontrolled hypertension. For increasing yield of autologous blood if the month preceding treatment the patients have suffered NEORAL Novartis MI, stroke, have unstable angina, are at risk of DVT. 2MT B Hypertension, thrombocytosis. History of Fungal metabolite immunosuppressant. epilepsy. Chronic hepatic failure. Correct other Cyclosporin 25mg blue-grey oval cap., 50mg causes of anaemia; iron suppl. may be necessary. yellow-white oblong cap.; 100mg blue-grey Monitor Hb, BP, platelet count, serum electrolytes. oblong cap. All marked with S in a triangle and Limit Hb rise to Q2g/dL per month. Theoretically cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; could stimulate malignant growth. Neonates 100mg-30, A96.03. (except NeoRecormon 500). Pregnancy, lactation. 2MT A Hypertension, shunt thrombosis, ALSO NEORAL ORAL SOLUTION Cyclosporin anaphylactoid reaction, increased platelets. 100mg/ml. Oral soln. 50ml, A143.89. S Steroid dependent and steroid resistant NORDURINE Ferring nephrotic syndrome due to glomerular diseases. 2MO V See lit. D Uncontrolled hypertension, uncontrolled Vasopressin and analogues. Desmopressin (acetate) 0.1mg, 0.2mg. White, oval, convex tab. with single infection. Malignancy. score, engraved 0.1 or 0.2. 0.1mg-30, A19.57; 90, B Only use under specialist supervision. A58.65; 0.2mg-30, A39.13; 90, A117.39. Closely monitor renal and liver function, BP and S Cranial diabetes insipidus incl. postserum lipids, serum K+. Hyperkalaemia, hypophysectomy polyuria/polydipsia, primary hyperuricaemia. Pregnancy, lactation. Active herpes simplex infections should be cleared before nocturnal enuresis in patients from 5-65 years. Symptomatic treatment of nocturia in adults up to treatment. Not bioequivalent to Sandimmun; specify brand when prescribing. 65 years only, associated with nocturnal polyuria. C Systemic antibiotics, live vaccines, R Over 65 years, contraindicated. phenytoin, ketoconazole, fluconazole, V Diabetes insipidus: Initially 0.1mg three itraconazole, erythromycin, rifampicin, times daily; maintenance 0.1-0.2mg three times carbamazepine, barbiturates, Ca++ antagonists, daily. Primary nocturnal enuresis: Initially 0.2mg at HMG-CoA reductase inhibitors, colchicine, bedtime increasing up to 0.4mg. Nocturia: Initially nephrotoxic drugs, oral contraceptives, 0.1mg at bedtime increasing up to 0.2mg and propafenone, prednisolone, methylprednisolone, subsequently 0.4mg by weekly dose escalations.
192
OMNEXEL
Astellas
2MO Selective a1-blocker. Tamsulosin (HCl) 400mcg. Round, bi-convex, yellow, prolonged release filmctd tab. marked 04. 30, A25.46. S Lower urinary tract symptoms associated with BPH. P 1 daily swallowed whole with or without food. Q Not applicable. D History of orthostatic hypotension, severe hepatic insufficiency. B Hypotension may occur. Perform digital rectal examination, and if necessary PSA determination before therapy and periodically thereafter. Severe renal impairment (Q10ml/min). C Caution: Diclofenac and warfarin, other a1-adrenoceptor antagonists. A Dizziness.
OMSIL
Pinewood
2MO Selective a1-blocker. Tamsulosin (HCl) 400mcg. Orange/olive green cap. with black strip on both ends marked TSL 0.4. 30, A20.35. S Lower urinary tract symptoms associated with benign prostatic hyperplasia. P 1 daily after first meal, swallowed whole with glass of water while standing or sitting. Q Under 12 years, not recommended. D History of orthostatic hypotension. Severe hepatic insufficiency. Use in women. B May lower BP. Exclude other conditions producing similar symptoms. Examine prostate via rectum and if necessary determine PSA count, prior to treatment and regularly thereafter. Severe renal impairment (cc Q10 ml/min), caution. Angiooedema (discontinue if occurs). Intraoperative Floppy iris syndrome in patients undergoing cataract surgery. C Caution: Diclofenac, warfarin, other a1antagonist. A Dizziness.
OSVAREN
Fresenius Medical Care
2MO Phosphate binder. Ca++ acetate, 435mg (eq. to 110mg Ca++ ), Mg++ carbonate, 235mg (eq. to 60mg Mg++) White to yellowish, oblong film-ctd tab. with single score line. 180, A30.13. S Hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
P Initially, 3 tab. per day with a meal; may be increased to 12 tab./day max. Divide daily dose according to number of meals. Q Under 18 years, not recommended. D Hypophosphataemia. Hypercalcaemia with or without clinical symptoms. Elevated serum Mg++ levels q 2mmol/l, and/or symptoms of hypermagnesaemia. AV-block III. Myasthenia gravis. Lactation (not recommended). B Caution (continuous monitoring of serum Ca++, Mg++ and phosphate): Severe hyperphosphataemia refractory to therapy, refractory hyperkalaemia, clinical relevant bradycardia or AV-block II with bradycardia. May occur: Hypermagnesaemia, vascular and soft tissue calcifications (long-term use). Risk of hypercalcaemic episodes; warn patient of possible symptoms of hypercalcaemia. With concomitant digitalis glycosides, only admin. under ECG control and monitoring of serum Ca++ level. Reduce dose if diarrhoea occurs. Pregnancy (only use if benefits outweigh risks). Contains sucrose, Na+. C Avoid other oral medicinal products within 2 hrs before and 3 hrs after admin. Caution: Tetracyclines, biphosphonates, fluorides, some quinolones (e.g. ciprofloxacin), some cephalosporins (e.g. cefpodoxime, cefuroxime), ketoconazole, estramustine-preparations, anticholinergics, zinc, urso- and chenodesoxycholic acids, halofantrine, iron, vit. D and derivatives, thiazide diuretics, glycosides, adrenaline, levothyroxine, oestrogens, digoxin, nitrofurantoin, penicillamine. A GI disorders, hypercalcaemia, asymptomatic hypermagnesaemia.
B Caution: Impaired hepatic function. Carefully monitor patients for obstructive uropathy. Exclude prostate cancer by digital rectal examination and, if necessary, determination of PSA, prior to and during therapy. Causes decreases in serum PSA levels (consider when evaluating PSA data). Contains lactose. A Impotence, reduced libido, reduced volume of ejaculate.
P Nephropathy: Initially, 1.25mg once daily. If tolerated, should be doubled at intervals of 2-3 weeks. Max. 5mg daily. Discontinue diuretic 2-3 days prior to therapy; if not possible, reduce diuretic dose. Microalbuminuria to overt nephropathy (prevention): Initially 2.5mg once daily. If tolerated, double after 1 week and after another 3 weeks up to 10mg (usual maintenance). Q Not recommended (contra). D History of angioneurotic oedema PROLOSIN Niche relating to previous ACE inhibitor treatment. Pregnancy, lactation. 2MO B Aortic stenosis, outflow obstruction (not Selective a1-blocker. Tamsulosin (HCl) 400mcg. recommended). Hypotension, agranulocytosis, Brown/buff opaque prolonged release cap., bone marrow depression, hyperkalaemia, containing white pellets. 30, A16.52. angioneurotic oedema may occur. Assess renal S Lower urinary tract symptoms associated function prior to and during treatment. Impaired with benign prostatic hyperplasia. P 1 daily swallowed whole after 1st meal liver function (reduce dose), collagen vascular disease; monitor. Correct volume/salt depletion of the day. before initiating therapy. Surgery/ anaesthesia. Q Not applicable. Haemodialysis using high-flux membranes (avoid). D History of orthostatic hypotension, Driving/ operating machines. severe hepatic insufficiency. C Caution: Antidiabetics, NSAIDs. B Hypotension may occur. Perform rectal A Nausea, dizziness, headache, GI examination, and if necessary PSA determination before therapy and periodically thereafter. Severe disturbances, dry tickling cough, skin/mucosal reactions, sinusitis, bronchitis, conjunctivitis, hair renal impairment (Q10ml/min). C Caution: Diclofenac and warfarin, other loss. a1-adrenoceptor antagonists. RAMYTE Actavis A Dizziness.
2MO
PROSCAR
MSD ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4
hard cap. containing white powder, with light grey body and resp. light green, green or dark green cap, marked R on cap and strength on body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, A10.92. S Prevention of progression of microalbuminuria to overt nephropathy. P Initially, 2.5mg once daily. Double dose after 1 week, after 3 further weeks increase to 10mg. Maintenance: 10mg daily. Renal/hepatic impairment, see SPC. R Caution. D History of angioneurotic oedema relating to previous ACE inhibitor treatment. Pregnancy, lactation. Use in children. B Aortic stenosis or outlaw obstruction (not recommended). Renal impairment risk (dosage reduction and/or discontinue); assess renal function prior to and during treatment. Caution: Impaired liver function, volume- and salt-depletion (symptomatic hypotension risk), anaesthesia, surgery. May occur rarely: Agranulocytosis and bone marrow depression, reduction in red cell count, haemoglobin content and platelet count, hyperkalaemia, hyperkalaemia (hypertensive patients), angioneurotic oedema. Avoid haemodialysis using high flux polyacrylonitrile RAMIC Pinewood membranes and low-density lipoprotein apheresis with dextran sulphate. 2MO C Caution: Antidiabetics, NSAIDs. ACE inhibitor. Ramipril 2.5mg, 5mg. Hard caps. A Nausea, dizziness, headache, with light grey body and light green and green symptomatic hypotension, MI, cerebrovascular cap marked R on cap and strength on body. accident, chest pain, palpitations, rhythm 2.5mg-28, A6.07; 5mg-28, A8.46. disturbances, angina pectoris, impaired renal S Overt glomerular nephropathy. Nonfunction, GI disorders, hypersensitivity reactions, diabetic/diabetic overt and incipient nephropathy. cutaneous and mucosal reactions, vasculitis, muscle Prevention of progression of microalbuminuria to and joint pains, fever or eosinophilia, dry tickling overt nephropathy. cough, disturbances of balance, nervousness, 2MO restlessness, terror, sleep disorders, confusion, loss ALSO RAMIC 10MG Ramipril 10mg. Hard caps. of appetite, depressed mood, feeling of anxiety, with light grey body and dark green cap marked paraesthesiae, taste change/reduction/loss, muscle R on cap and 10 on body. 28, A11.54. cramps, erectile impotence, reduced sexual desire, increased blood urea nitrogen and serum S Prevention of progression of creatinine, deterioration of pre-existing microalbuminuria to overt nephropathy.
2NO
Selective 5-a reductase inhibitor. Finasteride 5mg. Blue apple-shaped film-ctd tab. marked with tab. name and MSD 72. 28, A13.67. S Treatment and control of benign PHOSEX Biofact prostate hypertrophy (BPH) to cause regression of 2MO the enlarged prostate, improve urinary flow, and Phosphate binder. Ca++ acetate 1g (equiv to Ca++ improve symptoms associated with BPH in patients 250mg). Yellow oval tab. marked PHOS-EX. 180, who have enlarged prostate and are not A27.29. immediate candidates for surgery. Prevention of S Correction of hyperphosphataemia with urological events to reduce risk of acute urinary chronic renal failure in patients undergoing retention and need for surgery in patients with dialysis. BPH. P Initially, 1 tab, swallowed whole during P Males only, 1 daily for at least six meals, 3 times daily. Titrate to desired serum months to assess response. Thereafter treatment phosphate level, usually 2-4 tabs. with each meal. should be continued long term. Q Not applicable. Max. daily dose: 12 tabs. B Obstructive uropathy. Exclude prostate D Hypercalcaemia. ++ cancer, perform evaluation prior to and during B Monitor serum phosphate and Ca therapy. Females may absorb drug from semen or regularly, Pregnancy, lactation. handling tabs.; risk in pregnancy. C Tetracyclines, ciprofloxacin, enoxacin, A Impotence, decreased libido, decreased norfloxacin, vitamin D, cardiac glycosides, volume of ejaculate. Breast tenderness and verapamil, gallopamil. enlargement, rash, hypersensitivity reactions incl. A GI disorders, hypocalcaemia. pruritus, urticaria, swelling of lips and face, PROFAL Actavis testicular pain.
2NO Selective 5-a reductase inhibitor. Finasteride 5mg. Blue, round, biconvex film-ctd tab. marked F5. 28, A20.66. S Treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH and to reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Only for patients with an enlarged prostate (prostate volume q ca. 40ml). P 5mg daily. Treatment for at least 6 months may be necessary. D Women, children.
194
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
RENAL
proteinuria.
RENAGEL
AND BLADDER DISORDERS
7.3
Q Under 6 years, not recommended; 6-14 peritoneal dialysis (monitor). Not indicated for hyperparathyroidism. Pregnancy (only use if clearly years, 1 cap twice daily before meals. D Pregnancy, lactation. B Oral anticoagulants and other agents C Not recommended: Ciprofloxacin. metabolised by the liver. Caution: Ciclosporin, mycophenolate mofetil, C Oral anticoagulants and other agents tacrolimus, levothyroxine, anti-arrhythmics, antimetabolised by the liver. seizure medications. May affect bioavailability of other medicinal products. SANDIMMUN Novartis A GI disorders.
Genzyme needed), lactation.
2NO Phosphate binder. Sevelamer HCl 800mg. Offwhite oval film-ctd. tab. marked with tab. name and strength. 180, A184.53. S Hyperphosphataemia in adults receiving haemodialysis or peritoneal dialysis, as part of multiple therapeutic approach to control renal bone disease development. P Initially 2.4g or 4.8g per day based on clinical needs and serum phosphorus level (see SPC). Must be taken 3 times/day with meals. Monitor serum phosphorus levels; adjust Renagel dose accordingly. Test serum phosphate every 2-3 weeks until stable serum phosphate level reached and on a regular basis thereafter. Q Under 18 years, not recommended. D Bowel obstruction. Hypophosphataemia. B Caution: Swallowing disorders, GI motility disorders, active IBD, major GI tract surgery, long-term chronic treatment. Intestinal obstruction or ileus/subileus may occur; monitor constipated patients and re-evaluate treatment if severe constipation or other severe GI symptoms occur. Monitor fat-soluble vitamins, folic acid. Hypocalcaemia or hypercalcaemia may occur (monitor Ca++ levels). Monitor serum bicarbonate and serum chloride levels. Peritonitis may occur in patients on peritoneal dialysis (monitor). Not indicated for hyperparathyroidism. Pregnancy (only use if clearly needed), lactation. C Not recommended: Ciprofloxacin. Caution: Ciclosporin, mycophenolate mofetil, tacrolimus, levothyroxine, anti-arrhythmics, antiseizure medications. May affect bioavailability of other medicinal products. A GI disorders.
RETACRIT
Hospira
2MT
Fungal metabolite immunosuppressant. Cyclosporin 25mg pale pink oval cap., 50mg yellow oblong cap.; 100mg dusky pink oblong cap. Erythropoietin. Epoetin zeta. Clear, colourless sln 1 25mg-30, A29.01; 50mg-30, A53.77; 100mg-30, for inj. in pre-filled syringe. 1000 IU/0.3ml-6, A54.59; 2000 IU/0.6ml-6, A104.82; 3000 IU/0.9ml-6, A105.50. A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5ml2NT 6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ ALSO SANDIMMUN ORAL SOLUTION Cyclosporin 0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; 100mg/ml. Oral soln. 50ml, A163.91. 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, S Steroid dependent and steroid resistant A273.01; 40000 IU/1ml-1, A363.97. nephrotic syndrome owing to glomerular diseases. S Anaemia associated with chronic renal V See lit. failure in adult and paediatric patients on D Hypersensitivity to cyclosporin. Impaired haemodialysis and adult patients on peritoneal renal function, uncontrolled hypertension, dialysis. Severe anaemia of renal origin uncontrolled infection. Malignancy other than of accompanied by clinical symptoms in adult skin. patients with renal insufficiency not yet B Monitor renal and liver function, BP and undergoing dialysis. serum lipids. Hyperkalaemia, hyperuricaemia. P Haemodialysis: Correction phase, 50 IU/ Pregnancy, lactation. kg (IV) thrice weekly; adjust dose if necessary by C Systemic antibiotics, live vaccines, 25 IU/kg thrice weekly in steps of at least 4 weeks. phenytoin, ketoconazole, fluconazole, Maintenance total weekly dose 75-300 IU/kg. itraconazole, erythromycin, rifampicin, Peritoneal dialysis: Correction phase, 50 IU/kg (IV) carbamazepine, barbiturates, Ca++ antagonists, twice weekly; maintenance, 25-50 IU/Kg (IV) twice HMG-CoA reductase inhibitors, colchicine, weekly. Renal insufficiency without dialysis: nephrotoxic drugs, oral contraceptives, Correction phase, 50 IU/kg (IV) thrice weekly; propafenone, prednisolone, methylprednisolone, adjust dose if necessary by 25 IU/kg thrice weekly K+suppl., K+sparing diuretics, lipid solutions, in steps of at least 4 weeks. Maintenance, 17-33 NSAIDs. IU/kg thrice weekly. A Renal and hepatic dysfunction, tremor, Q Haemodialysis: Correction phase as per GI disturbances, hypertrichosis, gingival hypertrophy, burning sensations (feet and hands), adults. Maintenance, see SPC. RENVELA Genzyme D Patients with Pure Red Cell Aplasia fatigue, muscle weakness or cramp, myopathy, malignancies, lymphoproliferative disorders. Rarely (PRCA) following treatment with erythropoietin. 2NO hyperkalaemia, hyperuricaemia, Uncontrolled hypertension. Patients unable to Phosphate binder. Sevelamer carbonate 800mg. hypomagnesaemia, oedema, convulsions, receive adequate antithrombotic prophylaxis. White to off-white tab. 180, A184.53. B Correct other causes of anaemia; ensure headache, rash, mild anaemia, haemolytic uraemic 2NO syndrome, weight gain, pancreatitis, colitis, ALSO RENVELA SUSPENSION Sevelamer carbonate adequate iron stores. Monitor BP, platelet count, paraesthesia, neuropathy, confusion, reticulocyte count, Hb. Chronic renal failure: 2.4g. Pale yellow powder. 60, A184.53. dysmenorrhoea, amenorrhoea, gynaecomastia, S Hyperphosphataemia: In adults receiving Monitor serum electrolytes; hyperkalaemia may encephalopathy. occur (discontinue until corrected). Caution: haemodialysis or peritoneal dialysis and in adults Epilepsy, chronic liver failure. PRCA may occur with chronic kidney disease, not on dialysis with TAMNIC Clonmel (discontinue immediately, see SPC). Increased risk serum phosphorus r1.78mmol/l. 2MO of thrombotic vascular events in cancer patients. P Initially 2.4g or 4.8g per day based on Tumour growth potential cannot be excluded. Selective a1-blocker. Tamsulosin (HCl) 400mcg. clinical needs and serum phosphorus level (see Pregnancy, lactation (only if benefit outweighs Orange/olive-green, modified-release hard caps. SPC). Must be taken 3 times/day with meals. risk). Contains phenylalanine. with black stripe at each end marked TSL 0.4, Monitor serum phosphorus levels and titrate C Ciclosporin. containing white pellets. 30, A15.07. sevelamer carbonate every 2-4 weeks until A Headache, dose-dependent increase in S Lower urinary tract symptoms associated acceptable serum phosphorus level reached, with BP, hypertensive crisis with encephalopathy-like with BPH. regular monitoring thereafter. symptoms, skin rashes, flu-like symptoms, PRCA, P 1 daily swallowed whole after 1st meal Q Under 18 years, not recommended. of the day. D Hypophosphataemia. Bowel obstruction. antibodies to erythropoietins, hypersensitivity reactions, thrombotic/vascular events, shunt D History of orthostatic hypotension, B Not recommended for chronic kidney thromboses. severe hepatic insufficiency. disease patients not on dialysis with serum B Hypotension may occur. Perform rectal phosphorus Q1.78mmol/l. Caution: Dysphagia, ROWATINEX Rowa examination, and if necessary PSA determination swallowing disorders, severe GI motility disorders, before therapy and periodically thereafter. Severe 2 gastric contents retention,abnormal / irregular renal impairment (Q10ml/min). Angio-oedema, Volatile oils. Essential oils a pbinenes 3.1g, bowel motion, active IBD, major GI tract surgery, rarely. Cataract surgery (discontinue 1-2 weeks long-term chronic treatment. Intestinal obstruction camphene 1.5g, borneol 1g, anethol 400mg, fenchone 400mg, cineole 300mg, olive oil to 10g. prior; do not initiate if surgery scheduled). or ileus/subileus may occur; monitor constipated C Caution: Diclofenac and warfarin, other Yellow ent-ctd spherical gelatin cap. 50, A5.97. patients and re-evaluate treatment if severe S Urolithiasis. Renal disorders. Prevention a1-adrenoceptor antagonists. constipation or other severe GI symptoms occur. A Dizziness. of urinary stone formation. Monitor fat-soluble vitamins, folic acid. P 1-2 caps four or five times daily before Hypocalcaemia or hypercalcaemia may occur TAMSU Rowex (monitor Ca++ levels). Monitor serum bicarbonate meals. In presence of colic, 2-3 caps four or five 2MO times daily. levels. Peritonitis may occur in patients on
5NT
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
195
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
to severe hepatic or renal impairment), severe ulcerative colitis, toxic megacolon. Hypersensitivity to peanut or soya. Pregnancy, lactation. B Assess other causes of frequent urination (incl. organic) before initiating. Neurogenic cause for detrusor overactivity (safety and efficacy not established). Treat infection if present. Caution: Bladder outflow obstruction at risk of urinary retention, GI obstructive disorders (e.g. pyloric stenosis), gastro-oesophageal reflux, drugs (e.g oral bisphosphonates) causing or exacerbating oesophagitis, decreased GI motility, autonomic neuropathy, controlled narrow-angle glaucoma, hepatic or renal impairment, risk for QT-prolongation, relevant pre-existing cardiac diseases. Contains lactose. C Other antimuscarinic agents, anticholinergics (e.g. amantadine, TCAs, certain neuroleptics ), metoclopromide, CYP3A4 inducers and potent / moderate inhibitors, CYP2D6 TEVAX Teva inhibitors. A Dizziness, headache, dry eye, dry throat 2MO and mouth, GI disorders, dysuria, insomnia. Selective a1-blocker. Alfuzosin (HCI) 10mg. White, round, bevelled-edges, prolonged release tab. 30, TRITACE sanofi-aventis A15.96. 2MO S Moderate to severe functional ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, symptoms of BPH. P 10mg daily, taken immediately after the 10mg. White, yellow, red and white oblong tabs. with score line on both sides. 1.25mg-28, A2.59; same meal each day. Swallow tab. whole with 2.5mg-28, A3.66; 5mg-28, A5.10; 10mg-28, A6.94. fluid and take initial dose at bedtime. S Non diabetic and diabetic overt/ Q Not recommended. D Conditions with orthostatic hypotension. incipient nephropathy. Prevention of progression Hepatic insufficiency. Severe renal impairment (no of microalbuminuria to overt nephropathy. P Non diabetic and diabetic overt/ data). incipient nephropathy, the initial dose is 1.25mg B Transient postural hypotension may once daily titrate according to response; max. 5mg develop. Caution: Hypersensitivity to other a1blockers, patients who developed pronounced one daily. Discontinue diuretic at least 2-3 days. hypotension with other a1-blockers; acute cardiac Hepatic impairment, max. 2.5mg once daily. failure. If angina pectoris recurs or worsens, Prevention of progression of microalbuminuria to discontinue. Intraoperative Floppy Iris Syndrome overt nephropathy, the initial dose is 2.5mg once may occur during cataract surgery. Contains daily increasing gradually to double the dose after lactose. 1 week and after another 3 weeks to 10mg usual C Not recommended: Other a1-blockers, maintenance dose. potent CYP3A4 inhibitors (ketoconazole, R No special dosage recommendations for itraconazole, ritonavir, clarithromycine, elderly patients apart from general warning about erythromycine). Caution: Antihypertensives, patients with renal or hepatic insufficiency or CHF nitrates. Anaesthetics (withdraw tab. 24 hours which may be common in elderly and concomitant previously). use of diuretic drugs. Dose titrated according to A Dizziness, headache, vertigo, malaise, need for BP control. postural hypotension, nausea, GI disorders, Q Not recommended. asthenia. D History of angioneurotic oedema. Aortic stenosis, outflow obstruction. Pregnancy, lactation. TOVIAZ Pfizer Hypersensitivity to ramipril. B CHF, hepatic impairment, blood 2NO dyscrasias. Renal impairment: reduce dose and Anticholinergic. Fesoterodine 4mg, 8mg. Resp., assess renal function prior to and during light blue or blue, oval, biconvex, film-ctd, treatment. Haemodialysis (avoid in patients prolonged-release tabs, engraved FS or FT on one dialysed with high flux membranes). Use with side. 4mg-28, A40.00; 8mg-28, A43.39. S Symptoms (increased urinary frequency caution in surgery and during anaesthesia. agents, K+sparing and/or urgency and/or urgency incontinence) that C Antihypertensive diuretics, K+suppl., lithium, antidiabetic agents, may occur in patients with overactive bladder NSAIDs. syndrome. A Nausea, vomiting, dizziness, fatigue, P Initially, 4mg once daily. May be increased to 8mg once daily (max daily dose). Full headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity treatment effect between 2-8 weeks; re-evaluate reactions. Rarely, symptomatic hypotension, efficacy after 8 weeks. Concomitant potent CYP3A4 inhibitors: Normal hepatic/renal function, angioneurotic oedema, syncope. Selective a1-blocker. Tamsulosin (HCl) 400mcg. Orange/olive-green, modified-release hard caps. with black stripe at each end marked TSL 0.4, containing white pellets. 30, A20.34. S Lower urinary tract symptoms associated with BPH. P 1 daily swallowed whole after 1st meal of the day. Q Not applicable. D History of orthostatic hypotension, severe hepatic insufficiency. B Hypotension may occur. Perform rectal examination, and if necessary PSA determination before therapy and periodically thereafter. Severe renal impairment (Q10ml/min). Angio-oedema, rarely. C Caution: Diclofenac and warfarin, other a1-adrenoceptor antagonists. A Dizziness.
max dose 4mg once daily; impaired hepatic/renal function, see SPC. Q Under 18 years, not recommended. D Urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), concomitant potent CYP3A4 inhibitors (moderate
196
P 1 three times daily. Q Not recommended. D Obstructive conditions of GI or urinary tracts. B Suspected glaucoma. Pregnancy. A Headache, nausea, fatigue, diarrhoea, blurred vision, dry mouth.
VESITIRIM
Astellas
2NO Anticholinergic. Solifenacin succinate 5mg (equiv. 3.8mg solifenacin), 10mg (equiv. 7.5mg solifenacin). Light-yellow tab. marked with logo and 150 on same side, light-pink tab. marked with logo and 151 on same side, resp. Both film-ctd and round. 5mg-30, A40.01; 10mg-30, A52.02. S Urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. P Recommended dose, 5mg once daily; if needed, increase to 10mg once daily. Severe renal impairment, moderate hepatic impairment or concomitant use of potent CYP3A4 inhibitor: Max. 5mg once daily. Swallow whole with liquids. Max. effect seen after 4 weeks. Q Children and adolescents, not recommended. D Urinary retention, severe GI condition (incl. toxic megacolon), myasthenia gravis or narrow-angle glaucoma and patients at risk for these conditions, patients undergoing haemodialysis, severe hepatic impairment, severe renal impairment or moderate hepatic impairment with concurrent treatment with potent CYP3A4 inhibitor. Lactation. B Assess other causes of frequent urination (HF or renal disease) before treatment. Start antibacterial therapy in case of UTI. Caution: Bladder outflow obstruction with risk of urinary retention, GI obstructive disorders, risk of decreased GI motility, severe renal impairment, moderate hepatic impairment, autonomic neuropathy, hiatus hernia/ gastroesophagal reflux. Contains lactose. Driving and using machines. Pregnancy. C Caution: Potent CYP3A4 inhibitors, agents (such as bisphosphonates) that can cause or exacerbate oesophagitis, cholinergic receptor agonists, other anticholinergics, GI motility stimulants, other CYP3A4 substrates with higher affinity and CYP3A4 inducers. A Dry mouth, constipation, nausea, dyspepsia, abdominal pain, blurred vision.
XATGER
Gerard
2MO
Selective a1-blocker. Alfuzosin (HCI) 10mg. White, round, bevelled-edge, prolonged release tab. 10mg-30, A22.41. S Moderate to severe functional symptoms of BPH. P 10mg daily, taken immediately after the same meal each day. Tab. should be swallowed whole with fluid and initial dose taken at bedtime. Reduced renal insufficiency: Adjust according to response. R 10mg daily, if initial lower dose is well tolerated. URISPAS Recordati Q Not applicable. 2MO D Conditions with orthostatic hypotension. Antispasmodic. Flavoxate (HCl) 200mg. White sug- Hepatic insufficiency. ctd tab. marked URISPAS 200. 90, A11.53. B Severe renal impairment (not recommended). Transient postural hypotension S Incontinence, frequency, urgency, may develop. Caution: Hypersensitivity to other a1nocturia and dysuria.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1
sucrose. C Contra: Non-selective irreversible MAOIs (or within 14 days of discontinuation), CYP1A2 inhibitors (fluvoxamine, ciprofloxacin, enoxacin). Avoid antidepressants (especially SSRIs, SNRIs, reversible MAOIs but also clomipramine, amitriptyline, venlafaxine, triptans, tramadol, tryptophan), other duloxetine-containing drugs. Caution: Anticoagulants, alcohol, CYP2D6 substrates (TCAs), sedatives (benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines), flecainide, lecainide, XATRAL Sanofi propafenone, metoprolol, smoking. St John’s Wort. 2MO A GI disorders, fatigue/asthenia, headache, Selective a1-blocker. Alfuzosin (HCl) 2.5mg. White dizziness, tremor, lethargy, somnolence, film-ctd tab. marked XATRAL 2.5. 60, A20.67. paraesthesia, blurred vision, vertigo, increased S Functional symptoms of BPH. sweating, decreased appetite, flushing, abdominal P 1 three times daily. Max. 4 daily. Renal pain, chills, insomnia, anxiety, sleep disorder, insufficiency: Initially 1 twice daily. Hepatic agitation, decreased libido. insufficiency: Initially 1 daily, increased to 2 depending on response. ZEMPLAR Abbott R Initial dose 1 morning and evening.
blockers, patients who developed pronounced hypotension with other a1-blockers; acute cardiac failure. If angina pectoris recurs/worsens, discontinue. Contains lactose. C Contra: Other a1-blockers. Caution: Antihypertensives, nitrates, potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir). Anaesthetics (withdraw tab. 24 hours previously). A Dizziness, headache, vertigo, malaise, postural hypotension, GI disorders, asthenia.
2MO
2JN
Vit. D analog. Paricalcitol 5mcg/ml. Soln for inj. in ampoule. 1ml, price on request. S Prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure. P Initial dose (mcg) baseline iPTH level (pg/ml)/ 80, no more frequently than every other day during dialysis or, where no haemodialysis access, by slow IV inj. for min. 30 secs. Max. dose, 40mcg. Titration: Target PTH range, 1.5-3 x ULN (150-300pg/ml for iPTH). If no satisfactory response, may be increased by 2-4mcg at 2- 4 week intervals. If iPTH levels decrease to Q150pg/ ml, decrease dosage. Q Not recommended. D Vit. D toxicity, hypercalcemia. B During dose adjustment, monitor serum Ca++ and phosphate levels closely (e.g., twice weekly). Hypercalcemia (q11.2mg/dl), reduce dose or interrupt treatment. Risk of adynamic bone lesions at abnormally low PTH levels. Contains propyleneglycol and ethanol. Pregnancy, lactation; only if benefit outweighs risk. YENTREVE Lilly C Phosphate or vit. D-related compounds, alum.- or magn.-containing preparations; do not 2NO take concomitantly. Caution: Digitalis, Ca++5-HT/NA reuptake inhibitor. Duloxetine (HCl) containing preparations or thiazide diuretics. 20mg, 40mg. Hard gastro-resistant caps. Opaque A Hypercalcaemia, hyperphosphataemia, blue cap and body marked 20mg and 9544. parathyroid disorder, pruritus, taste perversion. Opaque orange body and blue cap marked 40mg 8.1 ANTIBACTERIAL DRUGS and 9545. 20mg-28, A19.58; 40mg-56, A39.96. S Moderate to severe stress urinary ALTARGO GSK incontinence (SUI) in women. P 40mg twice daily. A starting dose of 2NO 20mg twice daily for 2 weeks before increase to Bacteriostatic. Retapamulin 10mg/g (1% w/w). 40mg may decrease risk of nausea and dizziness. Ointment. 5g tube, A10.10. Discontinue gradually over at least 1-2 weeks. S Short term treatment of superficial skin Q Children and adolescents, not infections including impetigo, infected small recommended. lacerations, abrasions, or sutured wounds. D Liver disease resulting in hepatic P Apply thin layer to affected area twice impairment, severe renal impairment, uncontrolled daily for five days. Treated area may be covered hypertension. Pregnancy, lactation. with sterile bandage or gauze dressing. ReB History of mania. Bipolar disorder, evaluate or consider alternate therapy if no seizures. Increased IOP, at risk for narrow-angle response within 2-3 days. glaucoma . Severe renal impairment. Elderly. Q Under 9 months, not recommended. 9 Hypertension, cardiac disease; monitor BP. months-17years, as per adults. Treated surface Conditions compromised by increased heart rate/ area should be R 2% of body surface area. BP. Bleeding anormalities may occur. Liver injuries B Infected lesions q10cm or total surface area q100cm2, impetiginous lesions q10 with have been reported. Hyponatraemia reported total surface area q100cm2. Sensitisation or severe rarely in elderly. Suicidal ideation and behaviour (monitor for depressive symptoms). Akathisia may local irritation (discontinue if occurs). Contains butylated hydroxytoluene. Keep away from eyes/ develop during the first few weeks. Contains ALSO XATRAL PROLONGED RELEASE Alfuzosin (HCl) 10mg. Yellow/white layered sust.-release tab. 30, A26.61. S Functional symptoms of benign prostatic hypertrophy. Adjunctive therapy with urethral catheterisation for Acute Urinary Retention related to BPH. P 1 daily swallowed whole after a meal. Q Not applicable. D History of orthostatic hypotension. Severe hepatic insufficiency. B Patients on treatment for hypertension; monitor BP regularly particularly at start of treatment. Coronary insufficiency; discontinue if angina symptoms deteriorate. Withdraw 24 hours prior to anaesthesia. Contains lactose. C Other a-blockers (contra). Caution: Antihypertensives, nitrates, potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir). A Faintness, vertigo, malaise, headache, GI disorders. Postural hypotension, asthenia.
mucous membranes. Do not use to treat MRSA infections, nor abscesses. Pregnancy, lactation (assess risk/benefit). C Avoid other topical products to same area. A Application site reactions, irritation.
AMIKIN
BMS
2NO Aminoglycoside. Amikacin (sulph.) 100mg/2ml, 500mg/2ml. Vial. 50mg/2ml x 5- A13.75; 250mg/ 2ml x 5- A59.03. S Serious infections due to amikacin sensitive organisms. P 15mg/kg IM or IV daily in two divided doses for up to 10 days; total max. 15g. UTI, 7.5mg/kg daily in two divided doses. Q Neonates, initially 10mg/kg then 15mg/ kg daily in two divided doses; others, same as adult. D Pregnancy. B Ensure adequate hydration. Renal impairment. C Frusemide, ethacrynic acid, anaesthetics, neuromuscular blocking drugs. A Ototoxicity, nephrotoxicity.
AMOCLAV
Rowex
2NO b-lactamase inhibitor/broad-spectrum penicillin. Amoxicillin (as amoxicillin trihydrate) / clavulanic acid (as K+ clavulanate) 250/125mg. Oblong, convex, off-white, scored film-ctd tab. embossed AXC375, one side and G twice on the other. 21, A6.08.
2NO ALSO AMOCLAV DUO Amoxicillin (as amoxicillin trihydrate) / clavulanic acid (as K+ clavulanate) 500/ 125mg. White, oblong, biconvex film-ctd tab. scored on both sides. 14, A6.88. S Infections of the respiratory tract, ENT, genito-urinary tract, abdominal, skin and soft tissue. P One 250mg/125mg tab. 3 times daily or one 500mg/125mg tab. twice a day taken at start of meal. Severe cases: May increase to two 250mg/ 125mg tabs. 3 times a day. Duration: Should not exceed 14 days without review. Renal impairment: Moderate, cc: 10-30ml/min: One 250mg/125mg tab. or one 500mg/125mg tab. 12 hourly; severe, ccQ 10ml/min: One 250mg/125mg tablet 12 hourly. Haemodialysis patients: One 500mg/125mg tab. every 24 hours plus 1 during dialysis; to be repeated at end of dialysis. Q Over 12 years, as per adults; under 12 years, not recommended.
2NO ALSO AMOCLAV SUSPENSION Amoxycillin (as amoxycillin trihydrate)125mg, clavulanic acid (as potassium clavulanate) 31.25mg. Off-white granules for oral suspension. 100ml-1, A3.40. S Infections of the upper and lower respiratory tract, kidneys and lower urinary tract, skin and soft tissues induced by gram- and gram+ amoxicillin-resistant microorganisms. Q Under 3 months, not recommended. 3-9 months, 2.5ml half-strength paediatric suspension 3 times daily. 9-24 months, 2.5ml paediatric suspension 3 times daily. 2-6 years, 5ml paediatric suspension 3 times daily. Renal impairment, haemodialysis patients, see SPC. D Hypersensitivity to penicillin or cephalosporins. Previous history of amoxicillinclavulanate associated jaundice or hepatic
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
197
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
dysfunction. B Not recommended: Infectious mononucleosis, lymphatic leukaemia. Caution: Long term use, history of allergic reactions (risk of anaphylaxis), asthma, liver and renal dysfunction, elderly; monitor regularly. In case of severe GI disturbances parenteral therapy is recommended. May occur: Pseudomembranous colitis, epileptiform convulsions, superinfections. May prolong bleeding time and prothrombin time. May precipitate in the bladder catheter at high urinary concentrations. Pregnancy (avoid unless necessary), lactation. Suspension contains aspartame. C Not recommended: Bacteriostatic chemotherapeutics/antibiotics (e.g. tetracyclines, macrolides, sulphonamides, chloramphenicol), disulfiram. Caution: Probenecid, allopurinol, digoxin, anticoagulants, hormonal contraceptives. May affect laboratory tests (non-enzymatic methods for determining urinary sugar, urobilinogen test). A Hypersensitivity reactions, skin reactions (exanthema, pruritus). GI disorders, increased liver enzymes levels, haematological changes.
(trihydrate) 125mg/1.25ml. Powder for 20ml (+ pipette), A3.56. S Bronchitis, respiratory tract, urinary tract, skin and soft tissue infections. Prophylaxis of endocarditis.
2NO
2NO
ALSO AMOXIL SYRUP FORTE Amoxycillin (trihydrate) 250mg/5ml. Powder for susp. Powder for 100ml, A1.85.
b-lactamase inhibitor/broad-spectrum penicillin. Clavulanic acid (K+ salt) 125mg, amoxicillin (trihydrate) 500mg. White to off-white ovalshaped film-ctd tab. debossed with AC and a score line on one side. 14, A4.51; 50, A16.12.
ALSO AMOXIL PAED. SUSP. Amoxycillin
2NO
ALSO AUGMENTIN DUO SUSPENSION Clavulanic acid (K+ salt) 57mg,amoxicillin (trihydrate) 400mg/ ALSO AMOXIL 3G SACHET Amoxycillin (trihydrate) 5ml. Sugar-free. Powder for-35ml, A5.12; 70ml, A A8.25. 3g. 2, 5.12. P 250mg-500mg three times daily. High Q 7-12 years, 5ml twice daily; 2-6 years, dosage therapy: 3g twice daily. Short course 2.5ml twice daily; 2 months-2 years, dose therapy: Two 3g doses with 10-12 hours between according to age and body weight, 25/3.6mg/kg/ day to 45/6.4mg/kg/day, see SPC. Under 2 months, doses. Gonorrhoea: 3g as a single dose. Dental Abscess: Two 3g doses, 8 hours apart. Prophylaxis not recommended. 2NO of Endocarditis: 3g orally, 1 hour before procedure. A 2nd dose may be given 6 hours later, ALSO AUGMENTIN 250/125MG Clavulanic acid (K+ if considered necessary or 1g IM inj. if oral dose salt) 125mg, amoxicillin (trihydrate) 250mg. White not tolerated. to off-white oval-shaped film-ctd tab. 21, A3.68; Q Up 10 years: 125mg orally, three times 100, A17.51. daily; may increase in severe infection. Severe/ S Infections of the respiratory tract, ENT, recurrent acute otitis media: 750mg orally, twice a UTI, skin and soft tissue. day for 2 days may be used as alternative in age P 1-2 three times daily. Q Over 12 years, as adults; under 12 years, 3-10 years. Prophylaxis of Endocarditis: Under 10: use susp. v adult dose. Under 5: t adult dose.
2NO
2NO
2NO
ALSO AMOXIL INJECTION Amoxycillin (Na+) 500mg. Powder in vials. 500mg-10, A7.77. AMOXIL GSK P 500mg IM eight hourly, or 1g IV six 2NO hourly for severe infections. Broad-spectrum penicillin. Amoxycillin (trihydrate) Q 50-100mg/kg daily in divided doses. 250mg, 500mg. Maroon/gold caps. marked with D Hypersensitivity to penicillins or cap. name and strength. 250mg-21, A1.91; 500mg- cephalosporins. 21, A3.10; 500mg-100, A14.75. B Infectious mononucleosis. 2NO A Erythematous rash. ALSO AMOXIL SYRUP Amoxycillin (trihydrate) AUGMENTIN DUO GSK A 125mg/5ml. Susp. Powder for 100ml, 0.92
2NO
P 1 twice daily. Q Under 12 years, use Augmentin Duo susp.; over 12 years, same as adults.
PRESCRIBING NOTES INFECTION Infection involves contamination of normally sterile tissues by organisms known to colonise body spaces above the diaphragm (usually gram +ve) or below the diaphragm (usually gram -ve). Anti-infectives: The ideal prevention and control of infections should be based on multi-disciplinary teams implementing infection control through guidelines. Clinical: The likely source and diagnosis of the infection, whether disseminated or localised, as well as the underlying patient condition needs to be established. Microbiology: The inferred pathogen, subject to lab test, as well as organism sensitivity (check local variations) requires confirmation. Drug: Choice of drug requires consideration of clinical efficacy, route of administration, toxicity and interactions as well as cost. Clinical signs and systems include: High temperature >38째C or <36째C in uncomplicated localised infections, tachycardia >90 bpm, tachypnoea, resp. rate >20/min, WBC, <12.0 or 4.0 x 109/L, local
ALSO AUGMENTIN PAEDIATRIC Clavulanic acid (K+ salt) 31.25mg, amoxicillin (trihydrate) 125mg/5ml. Powder for susp. Powder for 100ml, A2.05. Q Under 3 months, no oral presentation currently available; 3-9 months, 2.5ml half strength paediatric susp. three times daily; 9 months-2 years, 5ml half strength paediatric susp. three times daily; 2-6 years, 5ml paediatric susp. three times daily. 2-6 years, severe infections, 10ml three times daily.
2N ALSO AUGMENTIN INTRAVENOUS Clavulanic acid (K+ salt) 100mg, amoxicillin (Na+ salt) 500mg. Clavulanic acid (K+ salt) 200mg, amoxicillin (Na+ salt) 1g. Powder in vials. 600mg-10, A19.23; 1.2g10, A38.47. V See SPC.
2NO ALSO AUGMENTIN 875/125MG Clavulanic acid (as K+) 125mg, amoxicillin (trihydrate) 875mg. White to off white film ctd tab. marked Augmentin. 14, A27.95. P Mild to moderate infection: 1 twice daily at the start of a meal. Severe infections: 1 three times daily. Moderate or severe renal impairment: See SPC. Q Under 12 years, not recommended. D Hypersensitivity to penicillin or cephalosporins, previous history of co-amoxiclavassociated jaundice/hepatic dysfunction. B Pregnancy, lactation. Liver or renal impairment. Avoid in infectious mononucleosis. Monitor organ system functions during prolonged therapy. C Probenecid (not recommended). Caution: Anticoagulants, allopurinol, oral contraceptives. A Mucocutaneous candidiasis, diarrhoea, nausea, vomiting.
inflammation/purulence, hypotension, hyperglyceamia, raised ESR/plasma viscosity, raised serum
AVELOX
complement, raised C-reactive protein.
2NO
Monotherapy with a single agent is preferred. A combination of agents can be used for broad spectrum
Quinolone antibacterial. Moxifloxacin (HCl) 400mg. Dull red film-ctd tab. marked M400 one side and Bayer on reverse. 5, A16.07. S Respiratory infections: Acute exacerbation of chronic bronchitis (AECB). Community-acquired pneumonia (CAP), except severe cases. Acute bacterial sinusitis. P 400mg once daily. AECB, 5-10 days; CAP, 10 days; acute sinusitis, 7 days.
coverage of potential pathogens and prevention of resistance. The oral route is preferred. Inadequate dosing at a sub-therapeutic level is a common cause of treatment failure and emergence of resistance. The effectiveness of treatment should be visible within 4-5 days and measurable clinically and by laboratory testing. Patient monitoring should include screening for signs of toxicity. References available on request.
198
Bayer Schering
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES 250-500mg twice daily. RTIs: 250-750mg twice daily. Pneumococcal pneumonia: 750mg twice daily; not recommended as first-line treatment. 2NO Cystic fibrosis lower RTIs: 750mg twice daily. ALSO AVELOX IV Moxifloxacin 400mg. 250ml Gonorrhoea: single dose of 250mg. GI infections: bottle. 5, A154.36. 500-750mg twice daily. Inhalation anthrax: 500mg S Community-acquired pneumonia. twice daily. Severe renal impairment (ccQ20ml/ Complicated skin and skin structure infections in min): Half total daily dose. patients requiring initial parenteral therapy. Q Cystic fibrosis: (aged 5-17 years) with P 400mg once daily by inf. over 60 min; acute pulmonary exacerbation associated with P. may be followed by oral tab. admin. CAP, 7-14 aeruginosa infection, 20mg/kg twice daily (max. days; skin infection, 7-21 days. 1500mg) for 10-14 days. Inhalation anthrax: 15mg/ Q Children and growing adolescents, kg twice daily (max. 1000mg) for 60 days. Other contraindicated. indications, only if benefit outweighs risk. D History of tendon disease related to quinolone treatment. QT prolongation, electrolyte D Children and adolescents unless epiphyseal closures of long bones have occurred. disturbances particularly hypokalaemia, Pregnancy, lactation. bradycardia, HF, history of symptomatic B Caution: Epileptics, CNS disorders, arrhythmias. Impaired liver function. Severely history of convulsive disorders, defects in G6PD impaired renal function. Pregnancy, lactation. activity, renal insufficiency, severe dehydration. B Alertness may be impaired. Predisposition to seizures, G6PD defects. Ongoing Monitor: Pre-existent significant renal or hepatic disorders. Risk: Pseudomembranous colitis proarrhythmic conditions. Sunlight or UV rays. (discontinue), crystalluria (patients should be well Tendon inflammation (discontinue). Investigate if hydrated). Avoid direct exposure to UV-light. vision becomes impaired. Elderly with renal Tendon inflammation and rupture, particularly disorders. Tabs contain lactose. Contains Na+. elderly or concurrent treatment with Driving or using machines. corticosteriods. C Products inducing QT prolongation i.e. C Theophylline (monitor plasma levels, antiarrhythmics class Ia and III, neuroleptics, potentially life-threatening). Phenytoin, terfenadine, macrolides, antimalarials, azole glibenclamide, cyclosporine, methotrexate, NSAIDs, antimycotics, TCADs, antimicrobials, metoclopramide, anticoagulants, probenecid. antihistaminics, cisapride, vincamine IV, bepridil, diphemanil (all contraindicated). Drugs containing Cationic drugs, mineral suppl., sucralfate, antacids, highly buffered drugs; do not use within 4 hrs. bivalent or trivalent cations (not within 6 hrs), Avoid: Concurrent admin. of dairy products or Ca++ charcoal. Caution: Anticoagulants. fortified drinks. A Superinfection, headache, dizziness, QT A GI and CNS disturbances, cardiovascular prolongation in patients with hypokaleamia, GI disorders, hypersensitivity/skin reactions, hepatic/ disorders, diarrhea, abnormal liver function tests, renal disturbances, moniliasis, asthenia, inj. site reaction. hyperglycaemia, abnormal gait, pain, AZACTAM BMS thrombophlebitis, reversible arthralgia, joint swelling, myalgia, effects on haematological 2N parameters, abnormal laboratory findings. Monobactam. Aztreonam 500mg, 1g, 2g. Powder in vials. Vials-5 x 500mg, A30.67; 1 x 1g, A12.26; 1 BIRAVID Ergha x 2g, A24.50. 2NO S Gram-negative infections. Quinolone antibacterial. Ofloxacin 200mg. White P 1g eight hourly by IM or IV inj. or IV round, film-ctd tabs, scored on one side, marked inf., or 2g twelve hourly IV. Severe infections, 2g FXN and 200. 20, A6.49. six to eight hourly IV; max. 8g daily. UTI, 0.5-1g S Acute, chronic or recurrent respiratory eight to twelve hourly IM or IV. Gonorrhoea/ tract infections (RTI), e.g. bronchitis. Acute and cystitis, 1g single dose IM. Q Under 1 week, not recommended; over chronic urinary tract infections (UTI). 1 week, 30mg/kg eight hourly; over 2 years, severe Uncomplicated non-gonococcal gonorrhoea, nongonococcal urethritis and cervicitis. Infection infections, max. 50mg/kg six hourly. Max. total prophylaxis in neutropenic patients. Skin and soft daily dose 8g. tissue infection. D Pregnancy. P RTI: 400mg daily; may be increased to B Renal or hepatic dysfunction. Penicillin 400mg twice daily. UTI: 200-400mg daily; upper or cephalosporin sensitivity. Lactation. UTI, increase if necessary to 400mg twice a day. A Skin rashes, diarrhoea, vomiting. Local Gonorrhoea: Single dose of 400mg. Urethritis/ reactions at inj. site. Superinfections. cervicitis: 400mg daily in single or divided doses. Haematological and hepatobiliary reactions (rare). Neutropenia: 400-800mg daily for up to 2 months. Skin and soft tissue: 400mg twice a day. Renal BIOFLOXCIN Niche impairment: See SPC. Up to 400mg may be given 2NO as single dose, preferably in the morning. 4-quinolone. Ciprofloxacin 250mg, 500mg. White Q Contraindicated. round/oval (respect.) film-ctd scored tab. 250mgD Children or adolescents before A A A 10, 5.21; 20, 10.47; 500mg-10, 9.73; 20, epiphyseal closures. Pregnancy, lactation. History A19.48. of quinolone-induced tendon disorder. B Not recommended as 1st-line therapy S Infections caused by sensitive bacteria for pneumococcal pneumonia. Defects in G-6-PD such as gonorrhoea, RTIs, UTIs, GI infections. activity. Avoid strong sunlight and UV rays. Renal P 100-750mg twice daily, swallowed or hepatic disorders, history of psychiatric disease; whole with liquid, for 5-10 days. Determined by severity and infection type. Continue for at least 3 caution. Tendinitis or ruptured tendon may occur. Driving/ operating machines. days after symptoms have disappeared. Acute C magn./alum. containing antacids, cystitis: 100mg or 250mg twice daily. Other UTIs: Q Children and growing adolescents, contraindicated.
ANTIBACTERIAL DRUGS 8.1 sucralfate or iron preparations (2 hrs apart). Caution: Hypotensive agents, anticoagulants, drugs lowering seizure threshold (e.g. theophylline), glibenclamide, phenylpropionic acid derived NSAIDs. A Allergic reactions. Occasional CNS disturbances.
BRAMITOB
Chiesi
2NT Aminoglycoside antibiotic. Tobramycin 300mg/4ml. Nebuliser solution in single-dose container. Price on request. S Chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis. V 6 years and over: One single-dose container (300mg) twice daily (morning and evening) for 28 days. Keep dose interval close to 12 hours. Stop treatment for next 28 days. Alternate cycles of 28 days with and without treatment as long as beneficial. For inhalation only. Under 6 years, not recommended. B Monitor renal and 8 cranial nerve function (at baseline and monitor urea and creatinine levels at least every 6 full cycles). Discontinue if nephrotoxicity until tobramycin Q1mcg/mL. Caution: Auditory, vestibular or neuromuscular dysfunction, severe haemoptysis. Bronchospasm, ototoxicity reported. Pregnancy, lactation (only if benefits outweigh the risks). C Contra: Potent diuretics (eg. furosemide, ethacrynic acid), urea, mannitol. Avoid: Nephrotoxic or ototoxic drugs (ie. amphotericin B, cephalotin, ciclosporin, tacrolimus, polymyxins, platinum compounds), anticholiesterases, botulinum toxin. Caution: Diuretics. A Dyspnoea, cough, rales, increased expectoration, hoarseness, voice alterations, nausea.
BY-MYCIN
Ergha
2NO Tetracycline. Doxycycline (hyclate) 100mg. Opaque dark blue/white cap. 8, A1.87. S Infections due to doxycycline-sensitive micro-organisms (pneumonia, respiratory, GI tract, soft tissue, ophthalmic, UTI). STDs incl. acute gonococcal infections. P Usually 200mg with food or fluid on the first day then 100-200mg daily. STDs, see SPC. Q Not recommended. D Pregnancy, lactation. Obstructive oesophageal disorders. B Hepatic impairment. Oesophageal reflux disorders. Take with plenty of water and remain upright. Prolonged use. C Penicillin (avoid), methoxyflurane (fatal renal toxicity). Antacids, Ca++, iron, coumarin anticoagulants, barbiturates, carbamazepine, phenytoin. A Tooth discolouration, enamel hypoplasia, GI disturbances, oesophagitis, allergic reactions, photosensitivity, superinfections.
CALVEPEN
Clonmel
2NO Penicillinase sensitive penicillin. Penicillin V Ca++ 333mg. White oval film-ctd tab. coded 105 one side, marked with lion symbol on reverse. 100, A7.80. S Penicillin sensitive infections. Prophylactic management of patients with rheumatic fever.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
199
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
tabs. 250 and 500mg scored on both sides. 125mg14, A5.25; 250mg-14, A9.44; 500mg-14, A17.94. S Upper RTIs, bronchitis (acute and exacerbations); skin and soft tissue infections; uncomplicated lower UTIs and gonorrhoea; early stage Lyme disease and prevention of late complications (q12 years). P Upper RTIs: 250mg (-500mg) twice daily swallowed whole shortly after meal. Lower RTIs: 500mg twice daily. Lower UTIs: 125mg-250mg 2NO twice daily. Skin and soft tissue infections: 250ALSO CALVEPEN 250 SUSPENSION Penicillin V 500mg twice daily. Early Lyme disease: 500mg Ca++ 250mg/5ml. 100ml, A2.84. twice daily during 20 days. Gonorrhoea: Single P 20-40ml daily in three to four divided 1000mg dose; 1000mg probenecid orally may be doses. before meals. added. Duration usually 5-10 days. Q Over 6 years, 10-20ml daily in divided Q Over 12 years, as per adults. 5-12 years, doses. 1-6 years, 5-10ml daily in divided doses. 125-250mg twice daily; acute otitis media: 250mg Under 1 year, 2.5-5ml in divided doses. twice daily. Under 5 years, oral suspension advised. 2NO Under 3 months, no experience. ALSO CALVEPEN 666 Penicillin V Ca++ 666mg. D Hypersensitivity to cephalosporins and/ White film-ctd tab. coded 104 one side, lion or other beta-lactam drug. Lactation, pregnancy symbol on reverse. 100, A13.37. (unless benefit outweighs risk). P 1 tab. three times daily before meals. B Pseudomembranous colitis (discontinue Q Not recommended. if occurs). Severe GI disturbances (consider D Penicillin hypersensitivity. parenteral treatment). Renal impairment (Q20ml/ B Pregnancy, lactation. min), haemodialysis. Slight to moderate hearing A Hypersensitivity, maculopapular rashes, loss reported in children. urticaria, gastrointestinal disturbances, diarrhea. C Avoid pH enhancing drugs, Transient induction of liver enzymes, tetracyclines, macrolides, chloramphenicol. Caution: pseudomembranous colitis. Potential nephrotoxic drugs (e.g. diuretics, CEFODOX sanofi-aventis aminoglycosides, amphotericin), probenicide. Glucose tests using copper reagentia, Coombs 2NO tests. Cephalosporin. Cefpodoxime proxetil 130mg A Diarrhoea, vomiting, rashes. Jarisch(equiv. cefpodoxime 100mg). Cylindrical white tab. Herxheimer reaction reported following Lyme 10, A9.52. disease treatment (inform patients). Increased S Lower respiratory tract infections. serum creatinine and urea. Sinusitis. Other upper respiratory tract infections incl. tonsillitis and pharyngitis where infection is CIDOMYCIN PAEDIATRIC sanofirecurrent or chronic or caused by organisms aventis resistant to commonly used antibiotics. Urinary 2NO tract infections including cystitis, acute Aminoglycoside. Gentamicin (as sulph.) 10mg/ml. pyelonephritis, gonorrhoea and uncomplicated 2ml vial. 5, A3.99. gonococcal urethritis. Skin and soft tissue infections. S Serious systemic infections (UTIs, chest P 100-200mg twice daily taken during or infections, bacteraemia, septicaemia, severe immediately after meals. neonatal infections). Q Use paediatric suspension. Q Up to 2 weeks, 3mg/kg twelve hourly; 2NO over 2 weeks, 2mg/kg eight hourly. D Pregnancy. ALSO CEFODOX PAEDIATRIC SUSPENSION B Caution: Existent ear disease, previous Cefpodoxime proxetil 52mg (equiv. cefpodoxime aminoglycosides use. Renal impairment: Monitor 40mg) per 5ml. Banana flavoured granules to renal, auditory and vestibular function. prepare susp. 100ml, A11.58. S Lower respiratory tract infections. Acute C Contra: Other nephrotoxic or ototoxic otitis media, sinusitis. Other upper respirtory tract drug substances. Caution: Curare muscle relaxants, anaesthetics. Cephalosporins, loop diuretics, infections incl. tonsillitis and pharyngitis where penicillins, neomycin, kanamycin, amphotericin, infection is recurrent or chronic or caused by organisms resistant to commonly used antibiotics. cyclosporin, cisplatin, oral anticoagulants. A Ototoxicity and nephrotoxicity. Q Under 6 months, 8mg/kg daily in 2 divided doses (not recommended for infants under CIFLOXAGER Gerard 15 days); 6 months-2 years, 5ml twice daily; 3-8 years, 10ml twice daily; over 9 years, 12.5ml susp. 2NO or 1 tab. twice daily. 4-quinolone. Ciprofloxacin (HCl) 250mg, 500mg. B Pregnancy. White, biconvex cap-shaped, film-ctd tab. marked A Diarrhoea, stool changes. Nausea, CF 250 or CF 500 on either side of score line on abdominal pain, dyspepsia, vomiting, flatulence. one side and G on reverse. 250mg-10, A5.64; Pseudomembranous colitis. Headache, dizziness. 250mg-20, A10.84; 500mg-10, A10.51; 500mg-20, Rash, pruritus, urticaria. Thrombocytopenia, A21.04. leukopenia, eosinophilia. S Infections of the respiratory, GI and urinary tract incl. urethral, rectal and pharyngeal CEFTAL Rowex gonorrhea caused by sensitive bacteria. 2NO P 100-750mg twice daily swallowed whole Cephalosporin. Cefuroxime 125mg, 250mg, 500mg with liquid, depending on severity and type of (equiv. cefuroxime axetil 150.36mg, 300.72mg, infection (see SPC). Duration 5-10 days (acute 601.44mg). White/yellowish, biconvex, oblong cystitis, 3 days). Continue for min. 3 days after
P 3-6 tabs. daily in three or four divided doses before meals. Q Over 6 years, 500-1000mg daily in three or four divided doses before meals. (Use Calvepen 333 tabs. or Calvepen 250 susp. as appropriate). Aged 1-6 years, 250-500mg daily in three to four divided doses before meals. Aged under 1 year, 125-250mg daily in three to four divided doses before meals.
200
symptoms have disappeared. Q Children and growing adolescents, not recommended. If benefit outweighs risk, 7.5-15mg/ kg/day depending on severity in 2 divided doses. D History of quinolone-induced tendon disorder. Children/growing adolescents unless epiphyseal closures of long bones have occurred. Pregnancy, lactation. B CNS disorders (eg. epilepsy, history of convulsive disease), defects in G6PD activity, renal or hepatic disorders, severe dehydration. Not recommended as 1st-line therapy for pneumococcal pneumonia. Patients should be well hydrated. Tendon inflammation/rupture (discontinue). C Drugs containing magn., alum., Ca++ or iron salts (4 hrs apart). Caution: Theophylline, some NSAIDs, anticoagulants, cyclosporin, probenecid, glibenclamide, metoclopramide. A GI disturbances, CNS disturbances, hypersensitivity/skin reactions, hepatic and renal disturbances, arthralgia, joint swelling, myalgia, effects on haematological parameters.
CIFOX
Rowex
2NO 4-quinolone. Ciprofloxacin (HCl) 250mg, 500mg, 750mg. White, round, scored, film-ctd tab. embossed with cip 250 or white, oblong, scored, film-ctd tab. embossed with cip 500 or cip 750 resp. 250mg-10, A5.69; 250mg-20, A11.39; 500mg10, A10.60; 500mg-20, A21.20; 750mg-10, A18.31. S Infections of the respiratory, GI and urinary tract incl. urethral, rectal and pharyngeal gonorrhea caused by sensitive bacteria. Inhalation anthrax. Acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection in paediatric patients aged 5-17 years. P 100-750mg twice daily swallowed whole with liquid, depending on severity and type of infection (see SPC). Continue for min. 3 days after symptoms have disappeared. Gonorrhoea: 250mg single dose. Q Children and growing adolescents, generally not recommended. Paediatric cystic fibrosis: 20mg/kg twice daily for 10-14 days; maximum daily dose: 1500mg. Inhalation of anthrax: 15mg/kg twice daily (max. 1000mg daily) for 60 days. D History of quinolone-induced tendon disorder. Children and growing adolescents unless epiphyseal closures of long bones have occurred. Pregnancy, lactation. B CNS disorders (eg. epilepsy, history of convulsive disease), defects in G6PD activity, renal or hepatic disorders, severe dehydration. Not recommended as 1st-line therapy for pneumococcal pneumonia. Crystalluria has been reported. Patients should be well hydrated. Tendon inflammation and rupture (discontinue). Risk of pseudomembranous colitis, discontinue if suspected. Avoid direct exposure to excessive sunlight or UV-light. Abnormal lab. findings. Driving or operating machinery. C Contra: Tizanidine. Caution: Theophylline, phenytoin, anticoagulants, NSAIDs, cyclosporin, glibenclamide, methothrexate, probenecid, metoclopramide, omeprazole. Cationic drugs, mineral suppl., sucralfate, antacids, highly buffered drugs (wait 4 hours); avoid concurrent admin. of dairy or Ca++ fortified products. A Nausea, diarrhoea, rash.
CIPLOX
Actavis
2NO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1 continued for at least 3 days after body temperature returned to normal. Usual duration 314 days. Up to 28 days for prostatitis and 4-6 weeks or longer for osteomyelitis. Q 5-17 years: CF: 20mg/kg twice daily for 10-14 days; max. 1500mg daily. Other indications: Contraindicated. D History of quinolone-related tendon disorder. Pregnancy, lactation. Children under 5 years. B CNS disorders incl. epilepsy, myasthenia gravis, patients at risk for torsade de pointes arrhythmia. Crystalluria reported (patients should be well hydrated). Risk of pseudomembranous colitis (discontinue). G6PD deficiency. Significant renal or hepatic disorders. Avoid prolonged exposure to sunlight or UV-light. Tendon inflammation and rupture (discontinue). Driving/ using machines. C Tizanidine (contra). Cationic drugs, mineral supps, sucralfate, antacids, antivirals with buffered didanosine, dairy products (admin 1-2 hours before of 4 hours after). Avoid opiate premedicants. Caution: Theophylline, CYP1A2 substrates, phenytoin, oral anticoagulants, NSAIDs, ciclosporin, glibenclamide, mexiletine, probenecid, metoclopramide, benzodiazepine, methothrexate, ropinirole. A Nausea, diarrhoea, rash.
lower UTIs, 100mg twice daily. GI infections, 200400mg twice daily. Cystic fibrosis pseudomonal lower RTIs, 400mg three times daily. Upper and lower RTIs, 200-400mg twice daily as required. Severe life-threatening infection or organism less sensitive, 400mg three times daily. Pneumococcal pneumonia infections (second-line), 400mg three times daily. Inhalation anthrax, 400mg twice daily for 60 days. Q Cystic fibrosis (5-17 years), 10mg/kg IV three times daily for 10-14 days; max. 1200mg daily. Admin. over 60 mins. Eradication of infection due to Pseudomonas only occurs in a minority of cases. Inhalation anthrax, 10mg/kg IV twice daily for 60 days; max. 800mg daily. Other indications, not recommended in paediatric patients unless benefit outweighs risk. D Children and growing adolescents unless epiphyseal closures of long bones have occurred or where benefits exceed risks. Hypersensitivity to ciprofloxacin or other quinolones. Patients with a history of quinoloneinduced tendon disorder. Pregnancy, lactation. B Caution: Hypersensitivity, epilepsy, CNS disorders, history of convulsive disorders. Significant renal or hepatic disorders. Risk of pseudomembranous colitis (discontinue if suspected), crystalluria (patients should be well hydrated). Not recommended first-line for pneumococcal pneumonia. G6PD deficiency. CIPROXIN Bayer Schering Tendon inflammation and rupture especially in elderly or concurrent treatment with 2NO 4-quinolone. Ciprofloxacin 250mg, 500mg, 750mg. corticosteroids. Avoid direct exposure to excessive sunlight or UV-light. Abnormal lab. findings. Na+ White film-ctd tabs. marked with Bayer cross and intake of medical concern (900mg/100ml). Driving CIP 250 on reverse or marked with Bayer and CIP or operating machinery. A 500 or CIP 750 on reverse. 250mg-10, 3.39; 20, A6.79; 100, A33.92; 500mg-10, A6.31; 20, A12.62; C Contra: Tizanidine. Theophylline (potentially life-threatening, monitor plasma 100, A63.14; 750mg-10, A11.02. levels). CYP450 1A2 inhibitors, phenytoin, S Infections of the respiratory, gastroanticoagulants, NSAIDs, glibenclamide, cyclosporin, intestinal and urinary tract. Gonorrhoea, inhalation anthrax. Acute pulmonary exacerbation probenecid, methothrexate, omeprazole. For tab. only: Cationic drugs, polymeric phosphate binders, of cystic fibrosis associated with P. aeruginosa mineral suppl., sucralfate, antacids, highly infection in paediatric patients (5-17 years). buffered drugs (wait 4 hours); avoid concurrent P 100-750mg twice daily. Gonorrhoea, single dose of 250mg. Upper and lower RTIs, 250- admin. of dairy or Ca++ fortified products. A Nausea, diarrhoea. Inj./inf. site reactions. 750mg twice daily. Pneumococcal pneumonia infections (second-line), 750mg twice daily. Cystic CLAFORAN sanofi-aventis fibrosis pseudomonal lower RTIs, 750mg twice daily. Other infections, 500-750mg twice daily. 2N Severe infections, 750mg twice daily. Upper and Cephalosporin. Cefotaxime (as Na+ salt) 500mg, lower UTIs 250-500mg twice daily. Acute 1g, 2g. Powder in vials. Price on application. uncomplicated cystitis, 100-250mg twice daily for 3 S Septicaemia, respiratory tract infections. days. Other acute infections, duration 5 to 10 Meningitis. Soft tissue infections. UTI. days; continue at least 3 days after symptom P 1g IV or IM every 12 hours; serious remission. Inhalation anthrax, 500mg twice daily infections, 3-6g daily in three or four divided for 60 days. Renal impairment: moderate, max. doses; max. 12g daily. Use 2g by IV route. CIPROFLOXACIN TEVA Teva 1000mg daily; severe, max. 500mg daily. Q Neonates, 50mg/kg daily; others, 100R Dose as low as possible. 2NO 150mg/kg daily. Both in two to four divided doses; 4-quinolone. Ciprofloxacin 250mg, 500mg. White, Q Cystic fibrosis (5-17 years), 20mg/kg max. 200mg/kg daily. orally twice daily for 10 to 14 days; max. 1500mg film-ctd tabs, marked CIP 250 or CIP500 and B Penicillin sensitivity. Severe renal failure. daily. Eradication of infection due to Pseudomonas Pregnancy, lactation. breakline. 250mg round biconvex; 500mg capsonly occurs in minority of cases. Inhalation shaped. 250mg-10, A5.08; 250mg-20, A10.17; C Loop diuretics, aminoglycosides. anthrax, 15mg/kg orally twice daily for 60 days; 500mg-10, A9.46; 500mg-20, A18.94. A Pain at inj. site, hypersensitivity S Gram(-) infections includ. RTI, UTI (acute max. 1000mg daily. Other indications, not reactions. GI disturbances, candidiasis, eosinophilia, recommended in paediatric patients unless benefit uncomplicated cystitis, pyelonephritis), acute, neutropenia, leucopenia, thrombocytopenia, rise outweighs risk. uncomplicated gonorrhoea, prostatitis, severe in liver enzymes and blood urea. Positive Coomb’s 2N bacterial enteritis, skin and soft tissue infections, test. osteomyelitis, severe systemic infections (eg. ALSO CIPROXIN INFUSION Ciprofloxacin (as septicaemia, peritonitis). Children: Acute lactate) 2mg/ml. Soln. for inf. in bottle. 100ml, CLARITHROMYCIN RANBAXY A27.84; 200ml, A31.35. pulmonary exacerbation of cystic fibrosis (CF) Ranbaxy associated with P. aeruginosa infection. P 100-400mg twice daily. 400mg three 2NO P 100-750mg twice daily. Dosage times daily for severe life threatening infections. determined by severity and type of infection, Admin. 400mg dose over 60 mins., other doses 30- Macrolide. Clarithromycin 250mg, 500mg. Light sensitivity of causative organism and age, weight, 60 mins. Duration usually 5 to 7 days; continue at yellow, oval shaped biconvex film-ctd tab., renal function of the patient (see SPC). Should be least 3 days after symptom remission. Upper and embossed with C1 one side (250mg) or embossed 4-quinolone. Ciprofloxacin (as HCl) 250mg, 500mg, 750mg. White or yellowish, biconvex, scored filmctd tab. marked C followed by strength. Can be divided into equal halves. 250mg-10, A5.26; 250mg-20, A10.39; 500mg-10, A9.93; 500mg-20, A19.87; 750mg-10, A17.35. S Upper and lower RTIs. UTIs. GI/intraabdominal infections. Genital tract infections including gonococcal uretritis and cervicitis. Infections of the skin, soft tissue, bones, joints. Treatment and prophylaxis of infections in neutropenic patients. Prophylaxis of invasive infections due to Neisseria meningitides. Inhalation anthrax (post-exposure prophylaxis and curative treatment). P Dosage depends on indication, severity and site of the infection, susceptibility of causative organism. Usual dosage range, 500-750mg twice a day, swallowed whole with water. RTIs, duration 7-14 days (malignant external otitis requires 28 days up to 3 months). Others, see SPC. Renal impairment: 30-60ml/min, 250-500mg every 12 hours; Q30ml/min and dialysis, 250-500mg every 24 hours. Q CF: 20mg/kg twice daily with max. 750mg per dose for 10-14 days. Complicated UTIs and pyelonephritis: 10-20mg/kg twice daily with max. 750mg per dose for 10-21 days. Anthrax: 1015mg/kg twice daily with max. 500mg per dose for 60 days. Other severe infections: 20mg/kg twice daily with max. 750mg per dose. D History of quinolone-induced tendon disorder (unless clearly necessary). Pregnancy, lactation. B Children and growing adolescents (only if benefit outweighs risk due to risk of arthropathy). Discontinue if: Severe and persistent diarrhea, tendinitis and tendon rupture, seizures, polyneuropathy, hepatic necrosis/ failure. Patients at risk for torsades de pointes arrhythmia. Hydrate well and avoid excessive alkalinity of the urine (risk of crystalluria). G6PD deficiency (avoid). Avoid prolonged exposure to sunlight or UV radiation. Driving/using machines. C Contra: Tizanidine. Avoid methotrexate. Dairy products, multivalent cation-containing drugs and mineral suppls (eg. Ca++, magn., alum., iron), polymeric phosphate binders (eg. sevelamer), sucralfate or antacids, highly buffered drugs (eg. didanosine); administer ciprofloxacin 12 hours before of 4 hours after. Caution: CYP1A2 substrates (eg. theophylline, clozapine, ropinirole), probenecid, caffeine, pentoxifylline, phenytoin, oral anticoagulants, clozapine. A Nausea, diarrhoea.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
201
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
with C and 2 on either side of a breakline one side and notched both sides (500mg). 500mg tab. can be divided into equal halves. 250mg-14, A9.10; 500mg-14, A15.22. S Lower RTIs: Acute and chronic bronchitis, and pneumonia; upper RTIs: Sinusitis and pharyngitis; skin and soft tissue infections of mild to moderate severity. Eradication of H. pylori in patients with duodenal ulcers in appropriate combination with antibacterial therapeutic regimens and omeprazole or lansoprazole. P RTIs /skin and soft tissue infections: 250mg twice daily for 7 days. May be increased to 500mg twice daily for up to 14 days in severe infections. H. pylori eradication, 500mg twice daily as part of either of the following triple therapies: With lansoprazole 30mg twice daily and amoxycillin 1000mg twice daily for 7-14 days; with lansoprazole 30mg twice daily and metronidazole 400mg twice daily for 7days; with omeprazole 40mg daily and amoxicillin 1000mg twice daily or metronidazole 400mg twice daily for 7 days; with amoxycillin 1000mg twice daily and omeprazole 20mg daily for 10 days. Severe renal impairment: If necessary, reduce total daily dosage by half, e.g. 250mg once daily or 250mg twice daily in more severe infections, maximum treatment duration 14 days. Q RTIs/skin and soft tissue infections: Adolescents, as per adults. Not suitable for children under 12 years of age weighing less than 30kg. D Pregnancy (unless clearly needed). B Caution: Renal/hepatic impairment, hypersensitivity to lincomycin or clindamycin, myasthenia gravis, coronary vessel disease, history of ventricular arrhythmia, severe cardiac insufficiency, non-compensated hypokalemia and/ or hypomagnesemia, bradycardia (Q50 bpm). May result in an overgrowth of non-susceptible bacteria or fungi (discontinue if superinfection occurs). H. pylori may develop resistance to clarithromycin. Consider pseudomembranous colitis in patients who develop severe diarrhoea during or after therapy. Lactation (assess benefit/risk). C Contra: Ergot derivatives, CYP3A4, substrates, terfenadine, cisapride, pimozide. Avoid quinidine or disopyramide, oral midazolam. Caution: CYP3A4 inducers, drugs with potential to prolong QT, HMG-CoA reductase inhibitors (simvastatin, atorvastatin or cerivastatin), IV midazolam and other benzodiazepines metabolised by CYP3A4 (incl. triazolam and alprazolam), cyclosporine, tacrolimus, sirolimus, digoxin, warfarin, carbamazepine, theophylline, zidovudine, rifabutin. A Oral monilia, headache, smell alteration, GI disorders, elevated blood urea nitrogen.
suppression resulting in decreased recurrence of duodenal ulcer. P 250mg twice daily; if severe can be increased to 500mg twice daily. Duration: 6-14 days. Mycobacterial infections: 500mg twice daily (with other antimycobacterial agents); increased to 1000mg twice daily after 3-4 weeks if necessary. MAC prophylaxis: 500mg twice daily. Hp eradication: 500mg twice daily for 7-10 days as part of triple therapy or 500mg three times daily for 14 days as part of dual therapy, see SPC. Severe renal impairment: Half dose if necessary; max treatment 14 days. B Hepatic and renal impairment. Prolonged use may cause super-infection. Possibility of cross resistance between clarithromycin and other macrolide drugs. Discontinue if super-infection occurs. Pregnancy, lactation (not recommended). C Contra: Cisapride, pimozide, terfenadine (risk of prolongation of QT-time and cardiac arrhythmias), astemizole and other macrolides. Caution: Theophylline, carbamazepine, warfarin, ergot alkaloids, triazolam, midazolam, disopyramide, lovastatin, phenytoin, cyclosporin, tacrolimus, rifabutin, digoxin, zidovudine, ritonavir, HMG-CoA reductase inhibitors (e.g. lovastatin and simvastatin). A GI disorders, headache, altered taste, transient elevations of liver enzymes, stomatitis, glossitis, oral monilia and tongue discolouration. See SPC.
hepatitis and cholestatic jaundice, moderate rises in liver enzymes occasionally.
CLONAMOX
Clonmel
2NO Broad spectrum penicillin. Amoxycillin (trihydrate) 250mg, 500mg. Green/white caps. marked with cap. name and strength. 250mg-100, A12.15; 500, A61.00; 1000, A121.67; 500mg-100, A24.04; 500, A121.67.
2NO ALSO CLONAMOX SYRUP Amoxycillin 125mg and 250mg/5ml. 125mg-Powder to prepare 100ml, A1.48. 250mg-Powder to prepare 100ml, A3.05. S Respiratory, urinary tract, skin and soft tissue infections. P 250mg three times daily. Q Half adult dose. B Infectious mononucleosis. A Hypersensitivity reactions. GI disturbances.
CLONAMP
Clonmel
2NO Broad spectrum penicillin. Ampicillin 250mg, 500mg. Grey/red caps. marked CLONAMP. 250mg100, A6.12; 500mg-100, A11.16.
2NO
ALSO CLONAMP SYRUP Ampicillin 125mg, 250mg/ 5ml. 125mg-Powder to prepare 100ml, A0.80; 250mg-Powder to prepare 100ml, A1.46. S Respiratory, urinary tract and other Gram-positive and Gram-negative infections. CLAVAMEL FORTE Clonmel P 250-500mg six hourly. 2NO Q Half adult dose. b-lactamase inhibitor/broad spectrum penicillin. B Infectious mononucleosis. Clavulanic acid (as K+ salt) 125mg, amoxicillin (as C Oral contraceptives. trihydrate) 500mg. Yellow oblong tab. marked A Hypersensitivity reactions. GI 625. 14, A7.29. disturbances. S Infections of the respiratory tract, ENT, UTI, skin and soft tissue. CLONOCID Clonmel P 1 three times daily. 2NO Q Over 12 years, same as adults; under 12 Macrolide. Clarithromycin 250mg, 500mg. Light years, use susp. yellow, oval, biconvex, film-ctd tabs. 250mg 2NO marked C1; 500mg marked C and 2 on either side ALSO CLAVAMEL TABLETS Clavulanic acid (as K+ of breakline. 250mg-14, A9.31; 500mg-14, A18.57. salt) 125mg, amoxicillin (as trihydrate) 250mg. S Infections of upper or lower respiratory White oval film-ctd tab. 21, A5.90; 100, A28.11. tract, skin and soft tissue infections of mild to P 1-2 three times daily. moderate severity where penicillin is Q Over 12 years, same as adults; under 12 inappropriate. In combination with appropriate years, use susp. agents for the eradication of H. pylori (Hp) in 2NO patients with Hp associated ulcers. ALSO CLAVAMEL PAEDIATRIC SUSPENSION P 250mg twice daily for 6-14 days; may be Clavulanic acid (as K+ salt) 31mg, amoxicillin (as increased to 500mg twice daily in severe trihydrate) 125mg per 5ml. Powder for susp. infections. Continue at least for 2 days after Powder for 100ml, A3.71. symptoms have subsided. Streptococcus pyogenes Q Under 3 months, not recommended; 3-9 infections, duration at least 10 days. Hp months, 2.5ml HALF-STRENGTH paed. susp. three eradication: 500mg twice daily when given as part CLARYL Pinewood times daily; 9 months-2 years, 5ml HALF-STRENGTH of 1st line triple therapy. Severe renal impairment: 2NO paed. susp. three times daily (or 2.5ml FULL Half dose; max. 14 days. Q 12 years or younger less than 30kg, not Macrolide. Clarithromycin 250mg, 500mg. Yellow, STRENGTH paed. susp.); 2-6 years 5ml FULL suitable. oval, biconvex, film-ctd tab marked 250 or 500 on STRENGTH paed. susp. three times daily (or 2.5ml 2NO one side and CL on the other. 250mg-14, A10.67; FULL-STRENGTH paed. susp. three times daily). In severe infections doses may be doubled. 500mg-14, A18.15. ALSO CLONOCID SUSPENSION. Clarithromycin D Hypersensitivity to penicillin or S Lower and upper respiratory tract 250mg per 5ml. Granules for oral susp. 250mgcephalosporins, previous history of co-amoxiclavinfections, skin and soft tissue infections and 70ml, A8.49. disseminated or localised mycobacterial infections associated jaundice/hepatic dysfunction. S Streptococcal tonsillitis, otitis media, due to Mycobacterium avium/intracellulare. B Liver or renal dysfunction. Infectious skin and soft tissue infections of mild to moderate Localised infections due to Mycobacterium mononucleosis, lymphatic leukaemia, use in severe severity where penicillin is inappropriate. chelonae/fortuitum/kansasii. The prevention of GI complaints, severe allergies or asthma. Q 6 months or older, 7.5 mg/kg twice daily disseminated Mycobacterium avium complex Pregnancy, lactation. for 6-14 days. 125mg dosage : 1-2 years/8-11kg: (MAC) infection in HIV - infected patients with A Diarrhoea, indigestion, nausea, 2.5mlx2; 2-4 years/12-19kg: 5mlx2; 4-8 years/20CD4 lymphocyte counts R 100/mm3. Eradication of vomiting, candidiasis. Urticarial and erythematous 29kg: 7.5mlx2; 8-12 years/30-40kg: 10mlx2. 250mg dosage : 2-12 years, half 125mg dosage. Severe Helicobacter pylori (Hp) in the presence of acid rashes, transient leucopenia, anaemia. Rarely
202
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1 (unless clearly indicated). Caution: Astemizole and other macrolides, quinidine, disopyramid, drugs with potential to prolong QT, cyclosporin, tacrolimus, sirolimus, digoxin, theophylline, warfarin, zidovudine, inducers / strong inhibitors of CYP3A4. HMG Co-A reductase inhibitors. A Oral monilia, headache, smell alteration, GI disorders. Elevated BUN.
CSSTI or RIE is identified after initiation of therapy, consider alternative antibacterial therapy. Not effective in treatment of pneumonia. Deepseated infections require prompt surgical intervention (e.g. debridement, removal of prosthetic device, valve replacement). May occur: Increases in plasma creatinine phosphokinase (CPK; MM isoenzyme) levels associated with muscular pains and/or weakness and myositis, COLOMYCIN Forest myoglobinaemia and rhabdomyolysis; monitor plasma CPK at least once weekly, or more often 2NO (CPK q5x ULN, severe renal impairment, Polymyxin. Colistin sulphomethate Na+ 1 mega concurrent medications associated with unit. Powder in vials. 1 mega unit-10, A25.04. myopathy); if symptoms occur, monitor CPK every S Gram -ve systemic and ENT infections, 2 days; discontinue if CPK q5x ULN with surgery, burns and wounds. Aerosol therapy. P (Over 60 kg): 2 mega units eight hourly. unexplained muscle symptoms. If peripheral neuropathy symptoms occur, consider Q 50,000 units/kg daily in three divided discontinuation. Renal insuffiency: Caution, adjust doses. dosage. May occur: Superinfection, antibiotic2NO associated colitis and pseudomembranous colitis. ALSO COLOMYCIN TABLETS Colistin sulph. 1.5 C Discontinue medications associated with mega units. White quarter scored tab. marked myopathy; if cannot avoid, monitor for myopathy with P in a hexagon. 50, A87.00. symptoms and monitor CPK more than once 2NO weekly. Caution: Medicinal products reducing ALSO COLOMYCIN SYRUP Colistin sulph. 0.25 renal filtration (e.g. NSAIDs, COX-2 inhibitors). CLOROM Rowex mega units/5ml. Powder to prepare 80ml, A5.18. May cause apparent prolongation in Prothrombin S Gram-negative GI infections, preTime/International Normalised Ratio assays. 2NO operative bowel preparations. A Fungal infections, headache, nausea, Macrolide. Clarithromycin 250mg, 500mg. White, P 1-2 tabs. eight hourly. vomiting, diarrhoea, rash, infusion site reactions, oblong, convex, film-ctd tab. scored on both faces. Q Up to 15 kg, 5-10ml; 15-30kg, 15-30ml; abnormal liver function tests, increased CPK. 70ml-125mg/5ml, A4.39; 70ml- 250mg/5ml, A8.77. over 30 kg, same as adult. All eight hourly. S Lower and upper RTIs, skin and soft D Pregnancy, lactation. DALACIN C Pharmacia tissue infections of mild to moderate severity. B Renal dysfunction, shock, 2NO Eradication of H. pylori (Hp) in patients with Hp superinfections. associated ulcers in combination with appropriate C Caution: Cuaraniform muscle relaxants, Lincosamide. Clindamycin (HCl) 150mg. Hard gel antibacterial and ulcer healing agents. cap. with opaque lavender body and opaque antibiotics. P 250mg twice daily during 7-14 days. In maroon cap, marked ’P & U 225’. 150mg-24, A Perioral parasthesia, vertigo. A13.10; 100, A52.59. severe infections, can be increased to 500mg twice daily. Streptococcus pyogenes infections, duration CRYSTAPEN Britannia S Serious clindamycin-sensitive infections. min. 10 days. Continue therapy min. for 2 days P 150-450mg six hourly. 2NO after symptoms subsided. Hp eradication: 500mg Q Over 1 month: 12-24mg/kg daily in 4 Penicillinase-sensitive penicillin. Penicillin G Na+ twice daily in combination with amoxicillin divided doses. Under 1 year of age or weighing 600mg (1 mega). Unbuffered powder in vial. 1, 1000mg twice daily and omeprazole 20mg twice R10kg: Min 37.5mg 8 hourly. A0.51. daily during 7 days. 2NO S Infections of skin, soft tissue, respiratory Q 12 years and under with weight Q30kg, ALSO DALACIN C PHOSPHATE Clindamycin tract, ENT. not suitable. (phosphate) 150mg/ml. Soln for inf or inj. 5 x 2ml, P 600-1200mg IM or IV daily in two or 2NO A29.61; 5 x 4ml, A58.96. four divided doses. ALSO CLOROM SUSPENSION Clarithromycin P 600mg-2.7g by IM or IV inj. daily in Q Newborn infants, 50mg/kg/day in 2 125mg/5ml, 250mg/5ml. White granules for oral divided doses; Infants 1-4 weeks, 75mg/kg/day in 3 divided doses. susp. 70ml-125mg/5ml, A4.39; 70ml- 250mg/5ml, Q Over 1 month, 15-40mg/kg daily in divided doses; 1 month-12 years, 100mg/kg in 4 A8.77. divided doses. divided doses; max. 4g/day S Infections in children including lower D Lincomycin sensitivity. B See SPC. and upper RTIs, skin and soft tissue infections of B Discontinue use if persistent diarrhoea A Hypersensitivity reactions. GI mild to moderate severity. Acute otitis media. or colitis appear. Renal or hepatic impairment. disturbances. Q 1-12 years: Oral susp. only, approx. C Neuromuscular blocking agents. 7.5mg/kg (i.e. 8-11kg: 62.5mg; 12-19kg: 125mg; 20- CUBICIN Novartis A GI disturbances incl. pseudomembranous 29kg: 187.5mg; 30-40kg: 250mg) twice daily, 12 colitis. Jaundice and blood disorders. 2N hours apart, for 5-10 days. Antibacterial. Daptomycin 350mg, 500mg. Powder DISTACLOR LA D Hypersensitivity to other macrolides, Clonmel for conc sol for inf, in vial. 350-mg-1, A79.56; lincosamide and azalide antibacterial agents. 2NO A 500mg-1, 118.57. Severe hepatic/renal impairment. Hypokalemic Cephalosporin. Cefaclor 375mg. Sust-release blue S Complicated skin and soft-tissue patients (risk of prolongation of QT-time). infections (cSSTI), right-sided infective endocarditis tab. marked TA422O and LILLY. 14, A7.48. B Hepatic and renal impairment. (RIE) due to S. aureus, S. aureus bacteraemia (SAB) 2 N O Pseudomembranous colitis reported. Prolonged ALSO DISTACLOR LA FORTE Cefaclor 500mg. Blue, when associated with RIE or cSSTI. use may cause superinfection.Due to a risk of capsule-shaped, film coated, prolonged-released increased QT-interval, caution with coronary vessel P cSSTI without concurrent SAB: 4mg/kg tablets. 28, A10.84. admin once every 24 hrs for 7-14 days or until disease, history of ventricular arrhythmia, severe infection is resolved. cSSTI with concurrent SAB: S Acute bronchitis, pharyngitis and cardiac insufficiency, hypomagnesemia, 6mg/kg admin once every 24 hrs. Known or tonsillitis, pneumonia, lower UTI, skin and skin bradycardia (Q 50 bpm). Do not use in patients with congenital or acquired QT prolongation. May suspected S. aureus RIE: 6mg/kg admin once every structure infections. Adjust antimicrobial therapy 24 hrs. Renal insufficiency: See SPC for dose according to causative organism. cause exacerbation or aggravation of myasthenia adjustment. P Pharyngitis, tonsillitis, skin and skin gravis. Pregnancy (unless clearly necessary), Q Under 18 years, not recommended. structure infections: 375mg twice daily. Lower UTI: lactation. Tab. contains lactose. Susp. contains: D Pregnancy (unless clearly necessary), 375mg twice daily or 500mg once daily. Bronchitis: Sucrose, aspartame. 375mg or 500mg twice daily. Pneumonia: 750 mg C Contra: Ergot vasoconstrictors, cisapride, lactation. pimozide and terfenadine; substrates of CYP3A4 B If S. aureus infection focus other than twice daily. Infections caused by S. pyogenes, renal impairment: Half dose up to 14 days. D Hypokalemic patients. B Impaired hepatic function; hypersensitivity to other macrolides, clindamycin and lincomycin; coronary vessel disease, history of ventricular arrhythmia, severe cardiac insufficiency, non-compensated hypokalemia and/or hypomagnesemia, bradycardia; Myasthenia gravis. Pseudomembranous colitis, superinfections with insusceptible organisms (discontinue if occurs). Pregnancy and lactation (only if benefit outweighs risk). Suspension contains sucrose and source of phenylalanine. C Ergot derivatives, cisapride, pimozide, terfenadine, simvastatin or atorvastatin (all contra). Avoid quinidine, disopyramide, cerivastatin, midazolam, CYP3A4 substrates. Caution: CYP3A4 inducers, drugs with QTprolonging effect, HMG-CoA reductase inhibitors, digoxin, cyclosporin, tacrolimus, sirolimus, theophylline, zidovudine, ritonavir. A Headache, smell alteration, reversible tooth and tongue discoloration, taste perversion, GI disorders, oral monilia, elevated BUN.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
203
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
admin. for at least 10 days. Dose safety of 4g/day demonstrated for 28 days. Haemodialysis: Loading dose of 250 to 1000mg prior to dialysis and 250 to 500mg every 6 to 8h between dialyses. Absorption enhanced with food. Q Not recommended.
ALSO ERYTHROPED PI SF Erythromycin (as ethyl succinate) 125mg/5ml. Sugar-free susp. Granules for 140ml-20, A3.76. S Prophylaxis and treatment of erythromycin sensitive infections.
2NO
ALSO ERYTHROPED FORTE SF Erythromycin (as ethyl succinate) 500mg/5ml. Sugar-free susp. Granules for 140ml-20, A12.97. P Mild to moderate infections: 1-2 g/day in divided doses. Severe infections: up to 4 g/day. Q Mild to moderate infections: 30mg/kg/ day in divided doses. Severe infections: up to 50 mg/kg/day in divided doses.
ALSO DISTACLOR SUSPENSION Cefaclor 125mg, 250mg/5ml. Granules for 100ml-125mg, A3.79; 250mg, A6.73. S Otitis media, UTI, respiratory tract, skin and soft tissue infections. P 250mg eight hourly, max, 4g daily. Q Under 1 month, not recommended; under 1 year, quarter adult dose; 1-5 years, half adult dose; over 5 years, same as adult. Max. 1g daily. B Hypersensitivity to penicillins. Renal impairment. May occur: Non-susceptible organisms overgrowth if prolonged use, pseudomembranous colitis, false positive for glucose in urine with Benedict’s, Fehling’s solutions or copper sulphate test tablets, positive Coombs’ test, cephalosporinpenicillin cross-sensitisation and cross resistance. Reported: Hepatitis, jaundice, nephritis (suspension). Pregnancy (only if clearly needed). Lactation. C Caution: Warfarin, probenecid, magnesium hydroxide/aluminium hydroxide containing antacids (take 1 hr apart). A Hypersensitivity reactions. GI disturbances. Fever. Vaginal moniliasis, vaginitis, genital pruritus. Haematological changes, abnormal urinalysis. Transient increase in BUN or creatinine. Nervousness, insomnia, dizziness, somnolence.
2NO
2NO ALSO ERYTHROPED ADULT Erythromycin (as ethyl succinate) 500mg. Yellow oval film-ctd tab. marked with makers symbol. 100, A27.24. P Mild to moderate infections, 2g/day in divided doses. For severe infections up to 4g/day. D Serious hepatic impairment. Lactation, pregnancy (unless essential). B Liver impairment. Hypertrophic pyloric stenosis reported in infants. C Contra: Terfenadine, astemizole, cisapride, pimozide, ergotamine, dihydroergotamine. Caution: Theophylline, digoxin, oral anticoagulants, lovastatin, simvastatin, triazolobenzodiazepines, colchicine, CYP3A4 substrates. A Gl disturbances. Allergic reactions.
FLAGYL
Amdipharm
2NO Macrolide. Erythromycin (as ethyl succinate) 250mg/5ml. Sugar-free susp. Granules for 140ml20, A7.32.
2NO
204
FLOXAPEN
Actavis
2NO Penicillinase-resistant penicillin. Flucloxacillin (Na+) 250mg, 500mg. Black/caramel caps. marked with name and strength. 250mg-28, A4.45; 500mg-28, A8.89.
sanofi-aventis 2 N O
2MO
Nitromidazole. Antibacterial. Metronidazole 200mg. Off-white film-ctd tab. and off-white cap.shaped film-ctd tab. Both marked with name and ERYTHROCIN Amdipharm strength. 200mg-21, A1.00; 250, A11.79; 400mg2NO 14, A1.41; 100, A10.04. Erythromycin (as lactobionate) 1g. Powder in vial. 2 M O A 1, 9.85. ALSO FLAGYL-S ORAL SUSPENSION V Severe and immunocompromised Metronidazole benzoate 200mg/5ml. Susp. 100ml, infections: 50mg/kg/day, preferably by continuous A6.17. inf., (equiv. 4g/day for adults). Mild to moderate S Prevention and treatment of infections infections (oral route compromised): 25mg/kg/day. due to anaerobic bacteria (esp. bacteroides sp, 2NO anaerobic streptococci, fusobacteria, clostridia). ALSO ERYTHROCIN Erythromycin stearate 250mg, Chronic pressure sores and ulcers with possible 500mg. White oblong film-ctd tabs. with maker’s anaerobic infection. symbol. 250mg-100, A14.00; 500, A68.20; 500mg- P Anaerobic Infections: Treatment: 800mg A 100, 28.12. followed by 400mg 8 hourly. Prophylaxis: 400mg 8 S Erythromycin-sensitive infections. hourly 24 hrs pre-operatively followed by IV or P 1-2g daily in divided doses. Max 4g rectal admin. post-operatively until oral dosing daily in severe infections. resumed. Pressure sores: 1200mg in 3 divided Q Mild to moderate infections: 30mg/kg/ doses. day in divided doses. For severe infections, up to Q Anaerobic Infections, treatment and 50mg/kg/day in divided doses. prophylaxis: 7.5mg/kg 8 hourly. D Serious hepatic impairment. Lactation, 2MO pregnancy (unless essential). ALSO FLAGYL SUPPS Metronidazole 500mg. B Liver impairment. Hypertrophic pyloric 500mg-10, A7.85. stenosis reported in infants. S Prevention and treatment of infections C Contra: Terfenadine, astemizole, due to anaerobic bacteria (esp. bacteroides sp., cisapride, pimozide, ergotamine and anaerobic streptococci, fusobacteria, clostridia). dihydroergotamine. Caution: Theophylline, P Treatment: 1g 8 hourly for 3 days, then digoxin, oral anticoagulants, lovastatin, 1g 12 hourly or switch to oral therapy. Prophylaxis: simvastatin, triazolobenzodiazepines, colchicine, 1g 8 hourly. CYP 3A4 substrates. Q Treatment: 7.5mg/kg 8 hourly. A Gl disturbances. Allergic reactions. Prophylaxis: 125-250mg 8 hourly.
ERYTHROPED SF
P Treatment: 500mg 8 hourly. Prophylaxis: 500mg pre-operatively and 8 hourly postoperatively. Q Treatment: Over 10 years, as per adult. Under 10 years, 7.5mg/kg 8 hourly. Prophylaxis: 500mg pre-operatively and 8 hourly postoperatively. D Active or chronic severe Peripheral and Central Nervous System diseases. B Peripheral or central neuropathy. Leucopenia. Transient epileptiform seizures. Monitor during prolonged use. Hepatic insufficiency or encephalopathy. Alcohol. Removed during haemodialysis. Fructose intolerance. Elderly. Darkens urine. Pregnancy, lactation. C Phenytoin, phenobarbital, anticoagulants, disulfiram, lithium, cyclosporin, 5fluorouracil, busulfan. Do not mix IV solution with: cefamandole nafate, cefoxitin sodium, dextrose 10% w/v, compound sodium lactate, penicillin G. potassium. A GI distress, furred tongue, unpleasant taste. Rash, urticaria, flushing, angioedema, CNS disturbances, headache, dizziness, confusion, hallucinations. Vision and blood disorders.
2N ALSO FLAGYL 0.5% SOLUTION FOR INFUSION Metronidazole 500mg/100ml. 10 x 100ml, price on application. Bags-20 x 100ml, price on application. S Prevention and treatment of severe infections due to anaerobic bacteria (esp. bacteroides sp., anaerobic streptococci).
ALSO FLOXAPEN SYRUP Flucloxacillin (as magnesium salt) 125mg/5ml, 250mg/5ml. 125mg/ 5ml, powder for 100ml, A2.56. 250mg/5ml, powder for 100ml, A7.88. S Skin, soft tissue, ENT and other infections due to Gram-positive organisms (incl. resistant staphylococci). As prophylactic agent during major surgery.
2NO ALSO FLOXAPEN INJECTION Flucloxacillin (as Na+ salt) 250mg, 500mg. Powder in vials. 250mg-10, A11.02; 500mg-10, A22.05. P 250-500mg three times daily taken orally or by IM or IV route. Osteomyelitis, endocarditis: up to 8g daily in divided doses, 6-8 hr. Surgical prophylaxis: 1g - 2g IV at start of anaesthesia followed by 500mg 6hr IV, IM or orally 6 hr intervals for up to 3 days. Oral dose to be taken v-1 hour before meals. Q Over 10 years, as per adults. 2-10 years, v adult dose; under 2 years, t adult dose. D Hypersensitivity to blactam antibiotics. History of flucloxacillin-associated jaundice/hepatic dysfunction. Ocular or subconjunctival admin. from Floxapen IV B Pregnancy, lactation. Newborns. Hepatic/renal impairment. Cap. and inj. contain Na+. C Probenecid. May affect gut flora. A Minor GI disturbances. Hypersensitivity reactions.
FLUCILLIN
Pinewood
2NO Penicillinase-resistant penicillin. Flucloxacillin Na+ 250mg, 500mg. Caramel coloured body with grey caps. with FXN250 and FXN500, logo on reverse. 250mg-100, A15.48; 500, A86.42; 500mg-100, A30.98; 500, A158.74. P 250mg, 4 times daily. Severe renal failure, reduce dose or extend dose interval.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES Q Under 2 years, a quarter of the adult dose. 2-10 years, half the adult dose.
2NO ALSO FLUCILLIN SUSPENSION Flucloxacillin (as Na+) 125mg/5ml. 100ml, A2.56. S Infections due to penicillinase producing staphylococci and other susceptible Gram+ organisms. P 750mg-1500mg daily in divided doses. Dosage may be increased if necessary. Severe renal failure, reduce dose or extend dose interval. Q Under 2 years, not recommended; 2-12 years, 50mg/kg BW in divided doses; over 12 years, as per adult. D Hypersensitivity to penicillins. History of flucloxacillin-associated jaundice/hepatic dysfunction, Pregnancy (unless benefit outweighs risk), lactation. B May occur: Anaphylaxis (discontinue), cholestatic jaundice (during treatment and up to 2 months post treatment). Caution: Hepatic dysfunction, underlying diseases, elderly, renal impairment, newborns (risk of hyperbilirubinemia). Regular monitoring of hepatic and renal function during prolonged treatments. Prolonged use may lead to superinfection, cross-resistance and crosssensitisation. Driving or operating machinery. Take v-1 hr before meals or on empty stomach. Contains sodium. C Probenecid. A Hypersensitivity reactions. Angioedema, thrombocytopenia, neutropenia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, interstitial nephritis. Minor GI disturbances.
ANTIBACTERIAL DRUGS 8.1 P 500mg three times daily. Severe infections, doses may be doubled. Q Use susp. 20-50mg/kg in divided doses.
2NO ALSO FUCIDIN SUSPENSION Fusidic acid 250mg/ 5ml. 50ml, A9.07. P 10-15mls three times daily. Q Under 1 year, 1ml/kg daily in three divided doses; 1-6 years, 5ml three times daily; 612 years, 10ml three times daily. D Tabs only: Biliary tract obstruction. B Perform periodic liver function tests. Pregnancy (theoretical risk of kernicterus), lactation. Susp only: Biliary tract obstruction. Susp contains sucrose, Na+. C Avoid: CYP3A4 substrates. Caution: Statins, oral anticoagulants, HIV protease inhibitors, ciclosporin. A Reversible jaundice (may be associated with acute renal failure). GI upsets, rash.
S Bacterial infections induced by gramand gram+ amoxicillin-resistant microorganisms whose resistance is caused by b-lactamases. Infections of respiratory tract (otitis media, sinusitis, acute exacerbation of chronic bronchitis, bronchiopneumonia), genito-urinary tract, skin and soft tissues. P Weighing more than 40kg, 1 three times daily with 8-hour intervals. Renal impairment: See SPC. Q Under 12 years, not recommended. Over 12 years, as per adult.
2NO
ALSO GERMENTIN SUSPENSION POWDER Amoxicillin (as trihydrate) 125mg / clavulanic acid (as K+ salt) 31.25mg in 5ml. Powder for oral suspension. 100ml, A3.39. Q 2-6 years, 5ml (1 spoonful) three times daily. 9-24 months, 2.5ml three times daily. 3-9 months, 2.5ml of half-strength suspension three times daily. Under 3 months, not recommended. GERAMOX Gerard Admin. at 8-hour intervals. Renal impairment: see SPC. 2NO D Hypersensitivity to penicillin or Broad spectrum penicillin. Amoxycillin (as trihydrate) 250mg, 500mg. Red/ivory caps. marked cephalosporins, previous history of co-amoxiclavassociated jaundice/hepatic dysfunction. Ax and strength also G. 250mg-15, A1.84; 50, B Lactation, pregnancy (increased risk of A6.14; 500, A61.41; 500mg-15, A3.68; 100, necrotising enterocolitis in neonates). Liver or A24.57; 500, A122.87. renal dysfunction, severe allergies or asthma. GERIFLOX Gerard Infectious mononucleosis, lymphatic leukaemia (not recommended). Elderly, long-term use. 2NO C Bacteriostatic chemotherapeutics/ Penicillinase-resistant penicillin. Flucloxacillin (Na+) antibiotics, disulfiram, hormonal contraceptives. 250mg, 500mg. Grey/brown caps. coded G and Caution: Probenecid, allopurinol, digoxin, FN250 or G and FN500. 250mg-100, A14.46; anticoagulants. 500mg-100, A28.92. A GI upset, exanthemas, pruritus, FLUCLON Clonmel S Infections due to penicillinase producing superinfections, moderate increase in liver staphylococci and other gram-positive organisms 2NO enzymes. susceptible to this anti-infective. Penicillinase-resistant penicillin. Flucloxacillin Na+ P 250-500mg three times daily v-1 hour HOSPIRA PIPERACILLIN/ 250mg, 500mg. Both blue/blue caps. marked with before meals. twin triangle logo and FXN 250 or FXN 500. TAZOBACTAM Hospira Q 4-12 years, 25mg/kg body weight in 250mg-250, A38.38. 500mg-250, A76.75. 2N divided doses. S Skin, soft tissue, ENT and other 2NO Broad spectrum penicillin/beta-lactamase inhibitor. infections due to Gram-positive organisms (incl. ALSO GERIFLOX ELIXIR Flucloxacillin (Na+) 125mg/ Piperacillin (Na+)/ tazobactam (Na+), 2g/0.25g; 4g/ resistant staphylococci). 5ml. 100ml bottle of pink, pineapple flavoured 0.5g. Powder for sln for inj. or inf. Prices on P 250-500mg three times daily v-1 hour granular powder for reconstitution to oral request. before meals. suspension. 1, A2.55. S Moderate to severe systemic and/or Q Under 10 years, not recommended; over P Orally administrated v-1 hour before local bacterial infections in which betalactamase 10 years, same as adults. meals. 750mg-1500mg daily in divided doses (ie. 2 producing bacteria suspected or detected. Adults/ A Hypersensitivity reactions, GI to 4 5ml teaspoons three times a day). Double if Adolescents/elderly: Nosocomial pneumonia, disturbances. necessary. complicated UTIs (incl. pyelonephritis), intraQ 2-12 years, 50mg/kg body weight in abdominal infections, skin and soft tissue FORTUM GSK divided doses (or half adult dose). infections, bacterial infections in neutropenic 2NO D Hypersensitivity to penicillins. adults. Children (2-12 years): Bacterial infections in Cephalosporin. Ceftazidime (as pentahydrate) Pregnancy, lactation. neutropenic children. 500mg, 1g, 2g. Powder in vials. 500mg-1, A5.75; B Severe renal failure (reduction in dose P By slow IV injection (over at least 3-5 1g-1, A11.46; 2g-1, A22.94. or extension of dose intervals). Potential min) or slow IV infusion (over 20-30 min). Usual S Infections of the respiratory tract, ENT, superinfection due to resistant organisms dose 4g/500mg every 8 hours. Total daily dose skin and soft tissues, bone and joints, biliary and (prolonged use). depends on severity and localisation of infection: GI tract. UTI. Septicaemia, meningitis. Infections in A Skin rashes (discontinue), GI From 2g/250mg to 4g/500mg admin. every 6 or 8 immunocompromised patients. disturbances. hours. Neutropenia: 4g/500mg every 6 hours in V See lit. combination with an aminoglycoside. Renal GERMENTIN Gerard B Penicillin sensitivity. Impaired renal insufficiency: See SPC. function. Pregnancy. 2NO Q Under 2 years, not recommended. 2-12 C Aminoglycosides, loop diuretics. b-lactamase inhibitor/broad-spectrum penicillin. years, neutropenia: Q40 kg, adjust dose to 90mg/ A Hypersensitivity reactions, GI Amoxicillin (as trihydrate) 500mg / clavulanic acid kg (80mg/10mg) every 6 hours in combination disturbances. See SPC. (as K+ salt) 125mg. Oval, biconvex, off-white, film- with an aminoglycoside, not exceeding 4g/500mg ctd tab. scored on both sides. 16, A8.55. every 6 hours. Renal insufficiency: See SPC. Over FUCIDIN LEO Pharma 2 N O 12 years, as per adults. 2NO B Hypersensitivity reactions to penicillins, ALSO GERMENTIN TABLETS Amoxicillin (as + Fusidic acid salt. Sodium fusidate 250mg. White cephalosporins, other allergens; discontinue if trihydrate) 250mg / clavulanic acid (as K salt) film-ctd ovoid tab. coded 121 one side, lion allergic reaction occurs. May occur: 125mg. Oblong, convex, off-white, film-ctd tab. symbol on reverse. 100, A81.07. marked AXC 375 on one side and twice G on Pseudomembranous colitis, leucopenia and reverse. 21, A6.13. S Staphylococcal infections. neutropenia (esp. prolonged therapy; periodic full AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
S Upper/lower respiratory tract infections, skin and soft tissure infections where parenteral therapy is required. P 500mg twice daily by IV infusion over KETEK sanofi-aventis 60 mins. using soln. concentration of 2mg/ml. R As for adults. 2NO Q Not recommended, insufficient data. Ketolide antibiotic. Telithromycin 400mg. Light D Serious hepatic impairment (IV only) orange film-ctd tab. marked H3647 one side, 400 B Renal or hepatic impairment. Pregnancy, A on reverse. 10; 27.86. S Community acquired pneumonia, acute lactation. exacerbations of chronic bronchitis, acute sinusitis, C Theophylline, oral anticoagulants, carbamazepine, digoxin, terfenadine, drugs tonsilitis/pharyngitis. metabolised by P450 (e.g.warfarin, ergot alkaloids, P Community acquired pneumonia, phenytoin, cyclosporin, tracrolimus, rifabutin). 800mg once daily for 7-10 days. Others, 800mg A Nausea, vomiting, abdominal pain and once daily for 5 days. diarrhoea, headache, rash, transient CNS effects, Q Not recommended. D History of long QT syndrome, known or inj. site reactions, taste perversion, transient liver enzyme elevation. aquired QT interval prolongation. Pregnancy, lactation. KLARAM Actavis B Coronary heart disease, ventricular 2NO arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, bradycardia (Q50bpm). Macrolide. Clarithromycin 250mg, 500mg. Yellow, INVANZ MSD Monitor patients on pravastatin, rosuvastatin or oval, biconvex film-ctd tabs marked 250 and 500 2JN fluvastatin for signs and symptoms of myopathy resp. on one side and CL on reverse. 250mg-14, A8.81; 500mg-14, A17.63. and rhabdomyolysis. b-lactam. Ertapenem 1g. Powder for soln. 1, A52.94. C Contra: Simvastatin, atorvastatin, S Lower and upper RTIs; skin and soft lovastastin; strong CYP3A4 inhibitors in patients S Intra-abdominal infections, community tissue infections. Disseminated or localised with renal impairment. Caution: Macrolides, acquired pneumonia, acute gynaecological mycobacterial infections due to M. avium or cisapride, ergot alkaloid derivatives, pimozide, infections and diabetic foot infections of the skin intracellulare; localised infections due to M. astemizole, terfenadine, rifampicin, phenytoin, and soft tissue. Prophylaxis of surgical site chelonae, fortuitum or kansasii. Prevention of carbamazepine, cyclosporin, tacrolimus, serolimus, disseminated M. avium complex (MAC) infection in infection following elective colorectal surgery in digoxin, statins, benzodiazepines, CYP3A4 adults. HIV patients with CD4 counts R100/mm3. H. pylori P 1g once daily by IV inf. over 30 mins for inhibitors, St.Johnâ&#x20AC;&#x2122;s wort. See SPC. eradication. 3-14 days. Prophylaxis of surgical site infection: 1g A Diarrhoea, nausea, vomiting, GI pain, P 250mg twice daily; can be increased to increased lliver enzymes, flush, palpitations, as single IV dose to be completed within 1 hour 500mg twice daily if more severe. Usual duration, dizziness, headache, taste disturbances, blurred prior to surgical incision. 6-14 days. Renal impairment (cc Q 30ml/min): Half vision, vaginal moniliasis, rash, pruritus. Q 13-17 years, as per adults. Under 3 dose for max. 14 days. Mycobacterial infections: months, not recommended. 3 months-12 years, Initially 500mg twice daily. If no response in 3-4 Abbott weeks, may be increased to 1000mg twice daily. 15mg/kg twice daily by IV inf. over 30 mins for 3- KLACID LA 14 days. Max 1g/day. 2NO MAC prophylaxis: 500mg twice daily. H. pylori D Hypersensitivty to penicillin, Macrolide. Clarithromycin 500mg. Modified release eradication: See SPC. cephalosporins, other b-lactams. Advanced renal D Known hypersensitivity to macrolides. yellow ovaloid film-ctd tab. marked with logo. 7 insufficiency, haemodiaylysis (no data). Lactation. (Cal/Pk), A14.16; Severe infection pack-14 (Cal/Pk), Lactation. B May occur: Superinfection, colitis and A28.32. B Caution: Renal/hepatic impairment, pseudomembranous colitis, seizures (esp. elderly possible cross resistance with other macrolides, S Upper and lower respiratory tract patients, pre-existing CNS disorders and/or lincomycin or clindamycin. Overgrowth of noninfections. Skin and soft tissue infections. compromised renal function). Pregnancy. Contains P 1 daily. Severe infections: 2 tabs. once susceptible bacteria (discontinue if superinfection Na+. Driving/operating machines. daily for up to 7 days. occurs). Pregnancy. C Not recommended: Valproic acid. Q Use paediatric susp. C Contra: Cisapride, pimozide, A GI disorders, infused vein complication, 2 N O terfenadine, astemizole and other macrolides (risk headache, rash, pruritus, inf. site pain. Raised ALT/ ALSO KLACID Clarithromycin 250mg. Yellow oval of QT prolongation), ergot derivatives. Caution: AST, alkaline phosphatase and platelet count. film-ctd tab. marked with logo. 14 (Cal/Pk), A5.83. Theophylline, carbamazepine, P450 substrates, digoxin, zidovudine, ritonavir. P 250mg twice daily. Severe infections, KEFLEX Clonmel A GI disorders, headache, altered taste, 500mg twice daily for 7 days. 2NO transient elevations of liver enzymes. Q Use paediatric susp. 2NO Cephalosporin. Cephalexin monohydrate 250mg. Gerard Dark green/white cap. coded LILLY H69. 28, A4.11; ALSO KLACID SUSPENSION Clarithromycin 250mg/ KLARIGER 100, A14.00. 5ml. Fruity-flavoured. Granules for 70ml, A5.27. 2NO 2NO Q Under 1 year (8kg), 0.15ml/kg; 1-2 years Macrolide. Clarithromycin 250mg, 500mg. Yellow, (8-11kg), 1.25ml; 3-6 years (12-19kg), 2.5ml; 7-9 ALSO KEFLEX TABLETS Cephalexin monohydrate oval, biconvex, film-ctd tab. marked C250 or C500 years (20-29kg), 3.75ml; 10-12 years (30-40kg), 5ml. on one side and G on reverse. 250mg-14, A9.70; 500mg. Peach oval tab. coded LILLY U49. 21, All twice daily. A5.99; 100, A27.40. 500mg-7, A9.34. 2NO 2NO S Lower and upper RTIs and skin and soft ALSO KLACID PAED. SUSP Clarithromycin 125mg/ tissue infections of mild to moderate severity. ALSO KEFLEX SUSPENSION Cephalexin 125mg, 5ml. Fruity flavoured. Granules for 100ml, A10.22; Eradication of H. pylori in patients with Hp 250mg/5ml. Powder for 100ml-125mg, A1.45; 70ml, A2.63. A 250mg, 2.93. associated ulcers in combination with appropriate Q Under 1 year (8kg), 0.3ml/kg; 1-2 years agents. S Respiratory tract, soft tissue and skin (8-11kg), 2.5ml; 3-6 years (12-19kg), 5ml; 7-9 years P 250mg twice daily for 7 days; if severe infections. UTI. Otitis media, bone and joint (20-29kg), 7.5ml; 10-12 years (30-40kg), 10ml. All can be increased to 500mg twice daily for up to infections. Dental infections. twice daily. 14 days. Hp eradication: 500mg twice daily for 7P 1-4g daily in divided doses. 2 N O 14 days as part of triple therapy or 500mg three Q 25-50mg/kg daily in divided doses. ALSO KLACID IV Clarithromycin 500mg (for times daily for 14 days as part of dual therapy. B Hypersensitivity to penicillins. Renal infusion only, should not be given as bolus or IM) Severe renal impairment: Half dose if necessary. insufficiency. Vial. 1, A13.95. Q Under 12 years, not recommended. C Loop diuretics, aminoglycosides.
blood count), bleeding manifestations, hypokalaemia (low K+ reserves; periodic electrolyte determinations), modest elevation of liver function indices, emergence of resistant organisms, neuromuscular excitability or convulsions (at higher doses by IV). Prolonged therapy: Assess organ system functions periodically (incl. renal, hepatic). Increased incidence of fever and rash in cystic fibrosis patients associated with piperacillin therapy. Not for use in children who do not have neutropenia or complicated appendicitis. Pregnancy, lactation (only if clearly indicated). Contains Na+. C Caution: Probenecid, tobramycin and gentamicin (severe renal dysfunction), vecuronium, methotrexate, heparin,oral anticoagulants and other drugs affecting coagulation incl. thrombocyte function. Possible cross reaction with Bio-Rad Lab Platelia Aspergillus EIA test. A GI disorders, rash (incl. maculopapular rash).
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A Hypersensitivity reactions. GI disturbances, eosinophilia, neutropenia, rise in liver enzymes. Positive Coombâ&#x20AC;&#x2122;s test.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1
B Hepatic/renal impairment. Prolonged use may cause super-infection. Hp organisms may develop resistance. Pregnancy, lactation (if benefit outweighs risk). Contains lactose. C Contra: Cisapride, pimozide, terfenadine (risk of QT prolongation and cardiac arrhythmias), astemizole, other macrolides. Caution: Anticoagulants, ergot alkaloids, benzodiazepines, anti-arrhythmics, HMG-CoA reductase inhibitors, anti-tuberculosis, AEDs, immunosuppresants, drugs prolonging QT, theophylline, digoxin, carbamazepine, zidovudine, ritonavir. A GI disorders , oral monilia, stomatitis, glossitis, tongue discolouration, headache, smell alteration.
scored tab. coded MZL 200 and white scored tab. coded MZL 400. Both marked with twin triangle logo on reverse. 200mg-21, A1.62. S Infections due to anaerobic pathogens. P 400mg three times daily. Q 7.5mg/kg body weight 3 times daily. B Pregnancy, lactation, liver disease. C Alcohol, oral anticoagulants, phenobarbitone, cimetitdine and lithium. A GI distress, furred tongue, unpleasant taste. Urticaria, angioedema, CNS disturbances, dark urine. Neuropathy, epileptiform seizures and leucopenia on long term therapy.
cause hyperkalaemia (monitor serum electrolytes). Monitor blood glucose if used with concomitant repaglinide. Lactation. C Caution: Folate antagonists, anticonvulsants, bone marrow depressant, phenytoin, digoxin, ciclosporin, warfarin and other coumarins, ACE inhibitors, procainamide, oestrogens, dapsone, repaglinide. Diuretics (K+ sparing diuretics, eplerenone and thiazides). A GI, dermatological, hypersensitivity, hepatic reactions.
MINOX 50
2NO
KOPEN
2NO
2NO
Rowex
Athlone Tetracycline. Minocycline 50mg. Yellow-brown
Penicillinase sensitive penicillin. Phenoxymethyl penicillin 250mg. White tab. marked Pen 250. 100, A4.05.
film-ctd tab. 100, A30.76. S Respiratory tract, skin and soft tissue, ENT infections, UTI. Prophylaxis of asymptomatic meningococcal carriers. P 200mg daily in divided doses. Gonorrhoea, males 200mg initially, followed by 100mg every 12 hours for a min. of 4 days with post therapy cultures within 2-3 days; females may require therapy for 10-14 days. Prophylaxis of asymptomatic meningococcal carriers, 100mg twice daily for 5 days usually followed by a course of rifampicin. Q Under 8 years, not recommended; over 8 years, 1 twelve hourly. D Pregnancy, lactation. B Hepatic impairment. C Antacids, mineral suppl., penicillins, anticoagulants. A GI disturbances, rarely allergic reactions. Superinfections.
ORAMOX
Antigen
Broad spectrum penicillin. Amoxycillin (as trihydrate) 250mg, 500mg. Yellow/ivory caps. marked with cap name and strength. 250mg-100, A18.60; 500, A90.84; 500mg-100, A36.64.
2NO
ALSO ORAMOX MIXTURE Amoxycillin (as trihydrate) 125mg, 250mg/5ml. 125mg-Powder to prepare 100ml, A2.27; 250mg-Powder to prepare 100ml, A3.79. ALSO KOPEN POWDER FOR ORAL SOLUTION Phenoxymethyl penicillin 125mg/ 5ml, 250mg/5ml. S Treatment of infections due to Off-white sugar-free granular powder. 125mg/5mlorganisms sensitive to amoxycillin. Oral prophylaxis 100ml, A1.45; 250mg/5ml-100ml, A2.32. of endocarditis related to dental procedures. Uncomplicated gonorrhoea. S Penicillin sensitive gram positive P Usual dosage, 250mg three times daily. infections. In severe infections dosage may be doubled. Oral P 250-500mg every 6 hours depending on prophylaxis, a single 3g dose prior to dental the severity of the condition. Long term procedure. Gonorrhoea, single 3g dose. prophylaxis of rheumatic fever: 250mg twice daily. Q Up to 10 years, half the adult dosage. R Reduce dose if renal function is Oral prophylaxis, single dose of 1-1.5 g prior to markedly impaired. dental procedure. Over 10 years, same as adult. Q Oral Solution: Under 1 year, 62.5mg six D Hypersensitivity to penicillins, or hourly, max. 250mg daily. 1- 5 years, 125mg six cephalosporins. hourly, max. 500mg daily. Over 5 years, as per B Infectious mononucleosis. Prolonged adult. use. Pregnancy, lactation. D Penicillin hypersensitivity. Pregnancy, MONOTRIM Chemidex C Probenecid. Methotrexate. lactation. A Nausea, vomiting, diarrhoea, skin B History of significant allergies and/or 2NO rashes, urticaria, angioedema, anaphylaxis, asthma. Impaired renal function, prolonged use Folic acid inhibitor. Trimethoprim 10mg/ml. Susp. pseudomembranous colitis. (may cause superinfection). 100ml, A25.31. C Bacteriostatic anti-infective agents, not S Trimethoprim-sensitive infections incl. PINACLAV Pinewood recommended. Indomethacin, salicylate. UTIs, RTIs and prophylaxis of recurrent UTIs. A Skin eruptions, sensitivity reactions, 2NO P 200mg twice daily for 7-10 days. fever, eosinophilia, GI upset. Prophylaxis of recurrent UTIs: 100mg at night and b-lactamase inhibitor/broad-spectrum penicillin. 250mg/125mg: Amoxicillin 250mg (as amoxicillin if necessary 100mg in the morning. Renal MERONEM AstraZeneca trihydrate), clavulanic acid 125mg (as K+ Impairment: See SPC. 2N clavulanate). 500mg/125mg: Amoxicillin 500mg (as Q Based on 6mg/kg/day in two divided Carbapenem. Meropenem 500mg, 1g. Powder in dosages as follows: 6 weeks to 5 months, 25mg; 6 amoxicillin trihydrate), clavulanic acid 125mg (as A A vial. 500mg, 186.65; 1g, 373.30. months-3 years, 25-50mg; 4-7 years, 50-75mg; 8-12 K+ clavulanate). Both light yellow oblong tabs. S Pneumonia, UTI, intra-abdominal, scored one side and marked 375 or 625 on other. years, 75-125mg. All twice daily for 7-10 days. gynaecological, skin and soft tissue infections, Prophylaxis of recurrent UTIs in children under 12 250mg/125mg-21, A6.10; 250mg/125mg-100, meningitis, septicaemia, febrile neutropenia. A29.15; 500mg/125mg-15, A7.94. years: 2.5mg/kg once daily in the evening. P 500mg-1g by IV bolus inj. over 5 mins or 2 N O S Infections of the respiratory tract, ENT, by IV inf. over 15-30 mins every 8 hrs. Meningitis, ALSO MONOTRIM TABLETS Trimethoprim, 100mg, UTI, skin and soft tissue. 2g every 8 hrs. P 250mg/125mg: 1 tab. three times daily. 200mg. White, round tab. with score line with Q Under 3 months, not recommended; 500mg/125mg: 1 tab. twice daily. Swallow tabs. resp. AE and 2 or DE and 5 on each side of score over 3 months, 10-20mg/kg by IV bolus inj. over 5 line. 100mg-100, A4.59; 200mg-100, A9.88. whole with water at start of meal. Impaired renal mins or by IV inf. over 15-30 mins every 8 hrs. function: See SPC. Hemodialysis patients: 1 tab. P RTIs and UTIs treatment: 200mg twice Meningitis, 40mg/kg every 8 hrs. daily. daily for 7-10 days; 1st dosage on 1st day may be B Hepatic impairment. Infections caused doubled. Prophylaxis of recurrent UTIs: Usual dose, Q Over 12 years with body weight r by methicillin resistant staphylococci. Pregnancy, 100mg at night; an extra 100mg may be taken in 40kg, as per adults. lactation. Pseudomembranous colitis has been 2NO the morning, if necessary. Renal impairment, see reported rarely. ALSO PINACLAV SUSPENSION Amoxycillin SPC. C Nephrotoxic drugs, probenecid. (trihydrate) 125mg, clavulanic acid (as K+ Q Children: Under 12 years, not A Nausea, diarrhoea, thrombocythaemia, clavulanate) 31.25mg per 5ml. Powder for susp. recommended. Over 12 years, as per adults. vomiting, inflammation, thrombophlebitis, pain. Powder for 100ml, A3.56. D Blood dyscrasias, severe renal Increased serum transaminases, bilirubin, alkaline insufficiency where blood levels cannot be Q Under 3 months, not recommended; 3-9 phosphatase, lactic dehydrogenase. monitored. Pregnancy, premature infants and months, 2.5ml half-strength susp.; 9 months-2 neonates Q 6 weeks. years, 2.5ml full strength susp. or 5ml halfMETRONIDE Clonmel B May cause depression of haemopoiesis. strength susp.; 2-6 years, 5ml full strength susp. All 2MO Perform regular haematological tests during long three times daily. term therapy. Caution: Folate deficiency. May Nitroimidazole. Metronidazole 200mg. White D Hypersensitivity to penicillin or
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
207
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
cephalosporins, severe hepatic impairment, previous history of amoxicillin-clavulanateassociated hepatic dysfunction. B Hepatic dysfunction. Severe GI complaints, glandular fever, lymphatic leukaemia; not recommended. Caution: Severe allergies or asthma, elderly. Long term use; monitor kidney/ liver functions and hematological controls regularly. Pregnancy (only if benefit outweigh risk), lactation. Susp. contains aspartame, Na+ and sucrose. Tabs. contain sucrose. C Bacteriostatic chemotherapeutics/ antibiotics (tetracyclines, macrolides, sulfonamides or chloramphenicol), disulfiram; not recommended. Probenecid, allopurinol, digoxin, anticoagulants, oral contraceptives; caution. A Hypersensitivity reactions; skin reactions (exanthema, pruritis). Dry mouth, taste disturbance, GI disorders, increased hepatic enzymes.
divided doses. Uncomplicated gonorrhoea: 3g single dose. Dental procedures: 3g single dose prior to procedure. Renal Insufficiency: Total daily dose may need reduction if excretion of drug is delayed. Q Over 10 years: 750mg in 3 divided doses. 6-10 years: 375-750mg in divided doses, 2-5 years: 375mg daily in divided doses. Under 2 years: 100-300mg daily in divided doses. Dental procedures: 3g single dose prior to procedure. D Pregnancy, lactation. B Infectious mononucleosis. Superinfection, anaphylaxis. Suspension contains sucrose and sodium. C Chloramphenicol, erythromycins, sulfonamides, tetracyclines, probenecid, copper sulphate laboratory tests. A Hypersensitivity reactions. GI disturbances.
Macrolide. Erythromycin (ethyl succinate) 125mg, 250mg, 500mg/5ml. 125mg-100ml, A1.96; 250mg100ml, A3.03; 500mg-100ml, A5.59. S Erythromycin sensitive infections. P 1g twice daily. Severe infections, max. 4g daily. Q Under 2 years, 125mg six hourly; 2-8 years, 250mg six hourly; over 8 years, same as adults. B Liver impairment. C Theophylline, oral anticoagulants, carbamazepine. A GI disturbance. Allergic reactions.
PROFLOXIN
Clonmel
2NO
4-quinolone. Ciprofloxacin (HCl) 250mg, 500mg. White or yellowish, scored, biconvex, film-ctd tabs. 250mg, round; 500mg, oblong. 250mg-10, A5.19; 20, A10.36; 500mg-10, A9.90; 20, A19.28. PIPERCIN Clonmel S Infections of the respiratory, GI and PINACLOR Pinewood 2 N urinary tract incl. urethral, rectal and pharyngeal 2NO Broad spectrum penicillin/beta-lactamase inhibitor. gonorrhea caused by sensitive bacteria. + + P 100-750mg twice daily swallowed whole Cephalosporin. Cefaclor 250mg. Purple/white cap. Piperacillin (Na )/ tazobactam (Na ), 4g/500mg. Marked CEFACLOR 250. 100, A31.73. Powder for sln for inj. or inf. 1 vial, price on with liquid, depending on severity and type of 2NO request. infection (see SPC). Duration 5-10 days. Continue for min. 3 days after symptoms have disappeared. S Moderate to severe systemic and/or ALSO PINACLOR SUSPENSION Cefaclor 125mg, Q Children and growing adolescents, not local bacterial infections in which betalactamase 250mg/5ml. Powder to prepare strawberry A producing bacteria suspected or detected. Adults/ recommended. If benefit outweighs risk, dosage flavoured susp. 125mg/5ml-100ml, 3.67; 250mg/ depends on severity of infection; admin. in two Adolescents/elderly: Nosocomial pneumonia, 5ml-100ml, A6.56. divided doses. complicated UTIs (incl. pyelonephritis), intraS Infections of the upper and lower D History of quinolone-induced tendon respiratory tract and middle ear incl. Streptococcus abdominal infections, skin and soft tissue disorder. Children and growing adolescents unless pyogens (group A beta haemolytic streptococci), infections, bacterial infections in neutropenic Branhamella catarrhalis. UTIs. adults. Children (2-12 years): Bacterial infections in epiphyseal closures of long bones have occurred. P 250mg eight hourly, max. 4g daily. Pregnancy, lactation. neutropenic children. Haemodialysis: 250mg -1g prior to dialysis B CNS disorders (eg. epilepsy, history of P By slow IV injection (over at least 3-5 followed by 250-500mg every 6-8 hrs convulsive disease), defects in G6PD activity, renal min) or slow IV infusion (over 20-30 min). Usual Q Under 1 month, not recommended; over dose 4g/500mg every 8 hours. Total daily dose or hepatic disorders, severe dehydration. Not 1 month, 20mg/kg daily in divided doses every recommended as 1st-line therapy for depends on severity and localisation of infection: eight hours. This may be increased to 40mg/kg pneumococcal pneumonia. Patients should be well From 2g/250mg to 4g/500mg admin. every 6 or 8 daily. Otitis media and pharyngitis, total daily dose hours. Neutropenia: 4g/500mg every 6 hours in hydrated. Tendon inflammation and rupture may be divided and given 12 hourly. Max. 1g (discontinue). combination with an aminoglycoside. Renal daily. C Drugs containing magn., alum., Ca++ or insufficiency: See SPC. D Pregnancy, lactation. iron salts (not within 4 hours). Caution: Q Under 2 years, not recommended. 2-12 B Hypersensitivity to penicillins, GI disease years, neutropenia: Q40 kg, adjust dose to 90mg/ Theophylline, some NSAIDs, anticoagulants, particularly colitis, impaired renal function. cyclosporin, glibenclamide, probenecid, kg (80mg/10mg) every 6 hours in combination Superinfection after prolonged usage, positive with an aminoglycoside, not exceeding 4g/500mg metoclopramide. Coombâ&#x20AC;&#x2122;s test, false positive Benedicts/Fehlingâ&#x20AC;&#x2122;s A GI disturbances, CNS disturbances, every 6 hours. Renal insufficiency: See SPC. Over Copper Sulphate test. Avoid: History of fructose hypersensitivity/skin reactions, hepatic and renal 12 years, as per adults. intolerance, glucose-galactose malabsorption, disturbances, arthralgia, joint swelling, myalgia, B Hypersensitivity reactions to penicillins, sucrase-isomaltase insufficiency. effects on haematological parameters. cephalosporins, other allergens. May occur: C Warfarin, probenecid. Pseudomembranous colitis, leucopenia and A Allergic reactions, GI disturbances, Roche neutropenia (esp. prolonged therapy; periodic full ROCEPHIN haematological reactions, hepatitis, jaundice, blood count), bleeding manifestations, 2NO + nephritis, nervousness, confusion, insomnia, hypokalaemia (low K reserves; periodic electrolyte Cephalosporin. Ceftriaxone (as disodium) 1g. dizziness, reversible hyperactivity, hypertonia, determinations), modest elevation of liver function Powder in vials plus solvent amps. (GMS)1g: (IM)-1, hallucinations, somnolence, genital puritus, indices, emergence of resistant organisms. A10.68; (IM/IV)-1, A10.68. vaginitis. Prolonged therapy: Assess organ system functions S Septicaemia, respiratory tract infections, periodically (incl. renal, hepatic). Increased renal and urinary tract infections, abdominal PINAMOX Pinewood incidence of fever and rash in cystic fibrosis infections, and soft tissue infections, meningitis, patients associated with piperacillin therapy. 2NO gonorrhoea. Prophylaxis of surgical infections. Pregnancy, lactation (only if clearly indicated). Broad spectrum penicillin. Amoxycillin 250mg, P 1g once daily by IM or IV inj. Severe Contains Na+. 500mg. Ivory/red caps. marked with cap. name infections: 2-4g once daily. Gonorrhoea: 250C Caution: Probenecid, tobramycin and and strength. 250mg-100, A12.26; 500, A61.43; 500mg IM or IV as a single dose. gentamicin (severe renal dysfunction), vecuronium, A A A 1000, 122.88; 500mg-100, 24.55; 500, 122.88. Q Neonates, max. 50mg/kg daily. standard methotrexate, heparin, oral anticoagulants and 2NO dose, 20-50mg/kg daily. Severe infections, max. ALSO PINAMOX SUSPENSION Amoxycillin 125mg/ other drugs affecting coagulation incl. 80mg/kg once daily. thrombocyte function. Possible cross reaction with D Cephalosporin hypersensitivity. Safety in 5ml, 250mg/5ml. 125mg-100ml, A1.54; 250mgBio-Rad Lab Platelia Aspergillus EIA test. 100ml, A3.07. pregnancy has not been established. S Infections due to organisms sensitive to A GI disorders, rash (incl. maculopapular B Care is required in patients with a rash). amoxicillin, oral prophylaxis of endocarditis from history of hypersensitivity (especially anaphylactic dental procedures, acute uncomplicated reaction) to penicillins. Severe renal impairment. PRIMACINE Pinewood gonorrhoea. Patients with radio-opaque gallstones or 2NO P Usual, total daily dose is 750mg in 3 obstructive biliary tract disease should be carefully
208
2
5
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c
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b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1
predisposition to allergic reaction; caution. Elderly or debilitated. Pregnancy, lactation (only if essential). C Caution: Penicillins, anticoagulants, aminoglycoside antibiotic, polymyxin B, colistin or high-dosed loop diuretics. SEPTRIN GSK A GI disturbances, headaches, dizziness, rashes. 2NO Folic acid inhibitor/sulphonamide. Trimethoprim SYNERCID Nordic 80mg, sulphamethoxazole 400mg; white tab. coded Y2B and marked WELLCOME. 100, A12.88. 2 J 2NO Streptogramin. Quinupristin 150mg and ALSO SEPTRIN ADULT SUSPENSION Trimethoprim dalfopristin 350mg. Vial containing powder for 80mg, sulphamethoxazole 400mg per 5ml. 100ml, soln. for infusion. 1, A69.60. S Nosocomial pneumonia, skin and soft A5.07. tissue infections, and clinically significant S Infections of respiratory and urinary infections due to vancomycin resistant E. faecium, tract. Otitis media. when no other treatment is appropriate. P 2 tabs. or 10ml twice daily. P Administer by central venous catheter in Q Under 6 years, use paed. susp.; 6_12 5% glucose soln. over 60min. then flush with 5% years, 1 tab. or 5ml twice daily. glucose soln. 7.5mg/kg, 8 hourly. Duration: 7 days 2NO (skin and skin structure infections), 10 days ALSO SEPTRIN FORTE Trimethoprim 160mg, (nosocomial pneumonia), or depending on site of sulphamethoxazole 800mg; white scored tab. infection (infections due to vancomycin resistant E. marked with tab. name and coded O2C. 100, faecium). A21.50. Q Under 18 years, not recommended. P 1 twice daily. D Hypersensitivity to other streptogramins. Q Not applicable. Severe hepatic insufficiency, raised bilirubin levels 2NO (q3 x ULN). Pregnancy, lactation (no data). ALSO SEPTRIN PAED. SUSP. Trimethoprim 40mg, B Patients at risk of cardiac arrhythmias. sulphamethoxazole 200mg per 5ml. 50ml, A1.57; Moderate hepatic insufficiency (consider dose A 100ml, 2.30. reduction to 5mg/kg closely monitored). Refrain 2JN ALSO SEPTRIN FOR INFUSION Trimethoprim 80mg, from driving (dizziness, headache). C Ergot alkaloid derivatives (avoid). Drugs sulphamethoxazole 400mg per 5ml; amp. 10, metabolised by CYP 3A4 system; avoid or closely A22.00 monitor (cyclosporin A, midazolam, nifedipin). Q Under 6 weeks, not recommended; 6 Rifampicin (closely monitor bilirubin), tacrolimus weeks-6 months, 2.5ml; 6 months-6 years, 5ml; 6(monitor blood level). Caution: Drugs that prolong 12 years, 10ml. All twice daily. the QTc interval, class Ia and III antiarrhythmic D Neonates, pregnancy. Severe renal or agents, neuroleptics, antidepressants, some hepatic insufficiency. Blood dyscrasias. Glucose-6antibiotics (antimalarial agents, fluoroquinolones, phosphate dehydrogenase deficiency. azole antimycotics, macrolides), some non-sedating B Lactation. Renal impairment-reduce or space out dosage. Perform regular haematological antihistamines, other anti-bacterial agents in patients with nosocomial pneumonia. tests during long term therapy. Rare hereditary A Local skin reactions (pain, infusion site problems of fructose intolerance, glucosereaction, oedema, inflammation, thrombophlebitis, galactose malabsorption or sucrase-isomaltase haemorrhage). Rash, pruritus, GI disorders, insufficiency, not recommended. headache, arthralgia, myalgia, asthenia, pain. C Folate inhibitors, anticoagulants, Increased level of bilirubin. anticonvulsants, hypoglycaemics. A Nausea, vomiting, glossitis, skin rashes. TARGOCID sanofi-aventis Blood dyscrasias. intestinal infections.
monitored. A Gastrointestinal, nausea, vomiting, stomatitis and glossitis, maculopapular rash, pruritus, urticaria and allergic dermatitis, anaemia, thrombocytopenia.
SUPRAX
2NO sanofi-aventis Glycopeptide. Teicoplanin 200mg, 400mg. Vials
2NO Cephalosporin. Cefixime 200mg. White, circular, convex film-ctd tab. marked ORO. 7, A11.37. S Infections due to cephixime sensitive pathogens such as Streptococci pneumoniae and pyogenes, E.coli, Proteus, H. influenza and B. catarrhalis, Klebsiella and Enterobacter species. P 200-400mg daily as single or in two divided doses. Renal impairment (Q20ml/min), max. 200mg once daily. Q Use paed. susp.
2NO ALSO SUPRAX PAEDIATRIC SUSP. Cefixime 100mg/5ml. Powder for oral susp. 50ml, A9.33; 100ml, A16.74. Q 9-12 years, 15ml daily as single or two divided doses; 5-8 years, 10ml daily; 2-4 years, 5ml daily; 6 months-2 years, 8mg/kg daily; under 6 months, not recommended. B Renal impairment, severe GI disturbances, parenteral or poor nutrition,
plus amps. of diluent (WFI). 200mg-1, A30.98. 400mg-1, A61.95. S Severe infections: joint, bone, septicaemia and endocarditis; Moderate infections: skin and soft tissue, UTI and LRTI, due to micro organisms sensitive to teicoplanin, including staphylococci resistant to other agents. Antimicrobial prophylaxis in orthopaedic and vascular surgery at risk of gram-positive infection. P Severe infections: 400mg I.V. every 12 hours for 3 doses followed by 400mg I.V. or I.M. daily. Moderate infections: 400mg I.V. on day 1 followed by 200mg I.V. or I.M. daily. Prophylaxis: 400mg I.V. at induction of anaesthesia. Dosage in elderly, CAPD patients and renal impairment, see SPC. Q Over 2 months: Severe infections and neutropenia 10mg/kg every 12 hours I.V. for first 3 doses followed by 10mg/kg I.V. or I.M. daily. Moderate infections: 10mg/kg I.V. every 12 hours for the first 3 doses followed by 6mg/kg I.V. or
I.M. dose. Neonates: 16mg/kg on first day, then 8mg/kg once daily I.V. inf. over 30 mins. D Hypersensitivity to teicoplanin. B Cross hypersensitivity with vancomycin, may occur. Thrombocytopenia, hepatic, renal or auditory impairment. Possibility of ototoxicity and superinfection. Pregnancy, lactation. C Caution: Other nephrotoxic or ototoxic drugs, e.g. streptomycin, neomycin, kanamycin, gentamicin, amikacin, tobramycin, cephaloridine and colistin. A Erythema, local pain, thrombophlebitis, injection site abscess. Rash, pruritis, fever, bronchospasm, anaphylactic reactions and anaphylactic shock, rigors, urticaria, angioedema. Toxic epidermal necrolysis. GI disturbances. Eosinophilia, leucopenia, thrombocytosis, neutropenia. Increased serum transaminases, alkaline phosphatase and creatinine. Renal failure, dizziness, headache, tinnitus and vestibular disorder.
TARIVID
sanofi-aventis
2NO Quinolone antibacterial. Ofloxacin 200mg yellowish-white film-ctd oblong tab. 20, A6.69. S Respiratory and urinary tract infections, skin and soft tissue infections due to Gram positive or Gram negative organisms sensitive to ofloxacin. P Respiratory tract infections, usually 400mg daily increasing if necessary to 400mg twice daily. Upper UTI, 200-400mg daily increasing if necessary to 400mg twice daily. Lower UTI, 200400mg daily for 3-10 days. Severe infections 300400mg daily. Non-gonococcal urethritis and cervicitis, 400mg daily in single or divided doses. Uncomplicated gonorrhoea, single dose of 400mg. Skin and soft tissue infections, 400mg twice daily. Q Not recommended.
2N ALSO TARIVID INFUSION SOLUTION (Hospitals only) Ofloxacin 100mg (as ofloxacin (HCl) 110mg) in 50ml soln. 200mg (as ofloxacin hydrochlor. 220mg) in 100ml soln. 100mg_50ml, A11.73. 200mg_100ml, A23.46. S Acute and chronic respiratory and urinary tract infections. P Respiratory tract infections, 200mg twice daily. UTIs, 100mg once daily to 100mg twice daily. Skin and soft tissue infections, 400mg i.v. twice daily. Q Not recommended. D Epilepsy. Pregnancy, lactation or women at risk of pregnancy. B Alertness may be impaired. Renal or hepatic disorders. Exposure to sunlight or UV rays. C Anticoagulants, mineral antacids, phenylpropionic acid derived NSAIDs. A Hypersensitivity reactions, CNS disorders incl. headache, dizziness, sleep disturbances, tremor, visual disturbances, psychotic reactions. Joint and muscle pains. GI upset. Changes in blood count.
TAVANIC
sanofi-aventis
2NO Fluoroquinolone antibiotic. Levofloxacin 250mg, 500mg. Yellowish-white to reddish-white oblong scored film-ctd tabs. 250mg-10, A21.88; 500mg-10, A31.71. S Acute bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, communityacquired pneumonia, uncomplicated UTIs,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
209
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
complicated UTIs including pyelonephritis, chronic bacterial prostatitis and skin and soft tissue infections. P Acute sinusitis: 500mg once daily for 1014 days. Chronic bronchitis: 250mg to 500mg once daily for 7-10 days. Community-acquired pneumonia: 500mg once or twice daily for 7-14 days. Uncomplicated UTIs: 250mg once daily for 3 days, complicated UTIs including pyelonephritis, 250mg once daily, for 7-10 days. Chronic bacterial prostatitis: 500mg once daily for 28 days. Skin and soft tissue infections: 250mg once daily or 500mg once or twice daily for 7-14 days. Renal insufficiency, see SPC.
Bio-Rad Lab. Platelia Aspergillus EIA test. Hartmannâ&#x20AC;&#x2122;s or Lactated Ringerâ&#x20AC;&#x2122;s solns compatible with Tazocin containing EDTA only. A Diarrhoea, nausea, vomiting, rash.
TETRALYSAL 2NO
Wyeth 2 N O
2NO Beta-lactamase inhibitor/broad-spectrum penicillin. Piperacillin (as Na+) with tazobactam (as Na+) 2.25g (2g: 250mg); 4.5g (4g:500mg). 4.5g (4g: 500mg); powder in vial. Price available on request. S Adults and elderly: Lower respiratory tract infections, complicated and uncomplicated UTI, intra-abdominal infections, skin and skin structure infections, bacterial septicaemia. Bacterial infections in neutropenic adults and children incl. neonates in combination with an aminoglycoside. Children: Appendicitis complicated by rupture with peritonitis and/or abscess formation in children aged 2-12 years. P 4.5g by slow IV inj. or inf. eight hourly. Neutropenia: 4.5g every 6 hrs in combination with an aminoglycoside. Renal insufficiency: See SPC. Q Neutropenia, incl. neonates, 90mg/kg every 6 hours; max. 4.5g every 6 hours. Complicated appendicitis: Under 2 years, not recommended; 2-12 years, 112.5mg/kg every 8 hours; max. 4.5g every 8 hours. Renal insufficiency: See SPC. B Assess haematopoietic function periodically; in long term therapy, also renal/ hepatic function. Patients with low K+ reserves. Bleeding, pseudomembranous colitis (discontinue if occurs). Evaluate patients with gonorrhoea for syphilis. Pregnancy, lactation (only if benefit outweighs risk). C Probenecid, drugs affecting coagulation, non-depolarising muscle relaxants, methotrexate.
210
TRUOXIN
Helsinn Birex
Galderma 2 N O
Antibiotic. Tetracycline (as lymecycline) equiv. 300mg base; gelatin cap. 28, A9.63. S Infections due to sensitive organisms. P 2 twice daily increasing to 4 daily if required. Q Not recommended. D Advanced renal insufficiency. Pregnancy, 2NO lactation. ALSO TAVANIC INFUSION Levofloxacin 5mg/ml. B Hepatic or renal insufficiency. Soln. in vial. 100ml. C Antacids/iron preps., anticoagulants. P Community-acquired pneumonia: 500mg A GI disturbances, diarrhoea, once or twice daily. Complicated UTIs including superinfection, photosensitivity. pyelonephritis: 250mg once daily. Chronic bacterial prostatitis: 500mg once daily. Skin and soft tissue TOBI Novartis infections: 500mg twice daily. Renal insufficiency, 2NT see SPC. Aminoglycoside antibiotic. Tobramycin 300mg/5ml. D Children and growing Nebuliser soln in 5ml ampoules. 56, A2947.09. adolescents.Epilepsy, history of tendon disorders S Long-term management of chronic with a fluoroquinolone. Pregnancy, lactation. pulmonary infection due to Pseudomonas B Tendinitis and tendon rupture, aeruginosa in cystic fibrosis patients. Clostridium difficile-associated disease, Q Under 6 years, not recommended. pseudomembranous colitis, predisposition to V 1 ampoule twice daily for 28 days with seizures, haemolytic reactions in glucose-6-PD 12 hrs (and not less than 6 hrs) between doses. patients, and hypoglycaemia. Avoid exposure to Stop for the next 28 days. Repeat cycle. UV radiation. Psychotic reactions, QT interval D Pregnancy, lactation. prolongation, peripheral neuropathy and B Renal, auditory, vestibular or hepatobillary disorders. neuromuscular dysfunction, severe haemoptysis; C Magnesium or aluminium containing caution. Monitor tobramycin levels only through antacids, iron salts, sucralfate, theophylline, venepunture. Bronchospasm can occur. fenbufen or similar NSAIDs, probenecid and C Avoid nephrotoxic or ototoxic drugs, cimetidine, ciclosporin, vitamin K antagonists. frusemide, urea or mannitol. Drugs known to prolong QT interval. A Voice alteration, transient tinnitus. A Diarrhoea, nausea, hepatic enzyme increased, phlebitis, infusion site reaction. TRIMOPTIN Athlone
TAZOCIN
procainamide, cyclosporin. Diagnostic tests (serum methotrexate assay with use of dihydrofolate reductase, Jaffe reaction).
Folic acid inhibitor antibiotic. Trimethoprim 100mg, 200mg. Flat, white, bevelled-edge tabs embossed TR100 and TR 200, resp. 100mg-100, A6.32; 200mg-100, A12.48. S Trimethoprim-sensitive infections incl. UTIs, RTIs and prophylaxis of recurrent UTIs. P UTIs and other infections, 200mg twice daily. Long term prophylaxis of recurrent UTIs, 100mg at night before bedtime. R Mild to moderate renal insufficiency, monitor serum levels of Trimoptin on days 2 to 4; adjust dosage according to cc (cc r25ml/min, reduce maintenance dose after 2 days; 10ml/minR cc R25ml/min, half dose). Q 4 months to 12 years, not recommended. Over 12 years, as per adults. D Infants under 4 months. Severe hepatic insufficiency. Severe renal insufficiency. Megaloblastic anaemia and other blood dyscrasias. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy, lactation. B Marked renal impairment: Avoid accumulation and resulting adverse hepatological effect. Regular haematological tests in long term treatment and patients predisposed to folate deficiency. Particular care in the haematological monitoring of children on long term therapy. Prolonged use may result in the development of super infection. C Warfarin. Certain diuretics (primarily thiazides) in elderly patients. Digoxin, phenytoin,
4-quinolone. Ciprofloxacin 250mg, 500mg. White or yellowish scored film-ctd tabs. marked C250 or C500. 250mg-10, A3.25; 20, A6.58; 500mg-10, A6.11; 20, A12.27. S Infections of the respiratory tract, UTI, GI tract incl. gonorrhoea caused by sensitive bacteria. P Respiratory tract infections, 250-750mg twice daily. Strep. pneumonia infections, 750mg twice daily. Cystic fibrosis pseudomonal infections, 750mg twice daily. GI infections, 500mg twice daily. UTI, 250-500mg twice daily. Acute uncomplicated cystitis, 250mg twice daily for 3 days. Gonorrhoea, single dose of 250mg. Other infections, 500-750mg twice daily. Severe infections, 750mg twice daily. Usual treatment period 5-10 days. Q Not recommended , but if essential 40mg/kg daily in two divided doses. D Growing adolescents except where benefits outweigh risk, patients with a history of quinolone-induced tendon disorders. B CNS disorders or history of convulsive disorders. Crystalluria has been reported - patients should be well hydrated. G6PD deficiency. Tendon infammation and rupture especially in the elderly and those on corticosteroids. Pregnancy, lactation. Avoid prolonged exposure to sunlight or UV radiation. C Magnesium, Ca++, alum. or iron containing medications, theophylline, oral anticoagulants, propionic acid-derived NSAIDs, phenytoin, probenecid, metoclopramide, glibenclamide, corticosteroids in the elderly. A Nausea, diarrhoea, rash, pruritus, GI disturbances, headaches, dizziness, CNS disturbances, migraine, peripheral oedema, fainting, hot flushes, allergic reactions, effects on haematological parameters, musculoskeletal disturbances, myasthenia gravis, hepatic and renal dysfunction, hypersensitvity/skin reactions. See SPC.
TRUOXIN I.V.
Helsinn Birex
2J 4-quinolone. Ciprofloxacin 2mg/ml. Clear, colourless to slightly yellow sln for inf. Vials: 200mg/100ml-10, A180.00; bags: 400mg/200ml-1, A20.00. S Adults: Lower RTIs due to Gram-ve bacteria; chronic suppurative otitis media; acute exacerbation of chronic sinusitis esp. if caused by Gram-ve bacteria; UTIs; epididymo-orchitis incl. cases due to N. gonorrhoeae; pelvic inflammatory disease incl. cases due to N. gonorrhoeae; GI tract infections; intra-abdominal infections; skin and soft tissue infections caused by Gram-ve bacteria; malignant external otitis, infections of bones and joints; treatment and prophylaxis of infections in neutropenic patients; inhalation anthrax (postexposure prophylaxis; curative treatment). Children and adolescents: Broncho-pulmonary infections in cystic fibrosis caused by P. aeruginosa; complicated UTIs and pyelonephritis; inhalation anthrax (postexposure prophylaxis and curative treatment). May be used to treat severe infections when necessary. P 400mg two to three times daily. Duration of treatment depends on indication, see SPC. After IV initiation of treatment, can be
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES switched to oral treatment with tab. or susp. if clinically indicated. Renal impairment: 30QccQ 60 ml/min, 200-400 every 12 h; ccQ30ml/min/ haemodialysis/peritoneal dialysis, 200-400mg every 24 h. R Adjust dose based on cc and severity of disease Q CF: 10mg/kg three times daily with max 400mg per dose for 10-14 days. Complicated UTIs and pyelonephritis: 6-10mg/kg three times daily with max. 400mg per dose for 10-21 days. Anthrax: 10-15mg twice daily with max. 400mg per dose for 60 days. Other severe infections: 10mg/kg three times daily with max. 400mg per dose. D Pregnancy, lactation. B Caution: Children and adolescents (arthropathy risk), myasthenia gravis, predisposition to seizures, patients at risk for torsade de pointes arrhythmia. Discontinue: Hypersensitivity/allergic reactions, tendinitis and tendon rupture, severe and persistent diarrhoea (antibiotic-associated colitis), hepatic disease, neuropathy symptoms. Avoid direct exposure to sunlight or UV-light. Crystalluria reported (patients should be well hydrated). G6PD deficiency (avoid). Contains Na+. Driving/using machines. C Contra: Tizanidine. Not recommended: Methotrexate. Caution: Probenecid, theophylline, caffeine, pentoxifylline, phenytoin, oral anticoagulants, ropirinole, clozapine. A GI disturbances, transient increase in transaminases, rash, inj./inf. site reactions.
ANTIBACTERIAL DRUGS 8.1 S Staphylococcal enterocolitis and pseudomembranous colitis. P 500mg every six hours or 1g every 12 hours, in NaCl or 5% dextrose IV inf. BP. Admin. each dose at no more than 10mg/min. Max. conc. 5mg/ml, or 10mg/ml in selected patients but with increased risk of inf.-related events. Admin. each dose over 60 mins. Usually response within 48-72 hours. Staphylococcal endocarditis, duration 3 weeks or longer. Q 10mg/kg per dose, every 6 hours (total daily dosage 40mg/kg). Neonates and young infants: Initially 15mg/kg, followed by 10mg/kg every 12 hours in 1st week of life and every 8 hours thereafter until one month of age. Admin. each dose over 60 mins. B Monitor peripheral blood state, liver and renal function regularly. Impaired renal function (see SPC). Previous hearing loss. Pregnancy (increase dose). Elderly, premature infants (reduce dose). C Neurotoxic or nephrotoxic drugs, anaesthetics. A Inf. related events (anaphylactoid reactions, flushing), nephrotoxicity, ototoxicity, neutropenia, phlebitis, chills, rash. Bullous disorder (discontinue).
D Latter half of pregnancy. Lactation. B Hepatic impairment. C Antacids, mineral suppl., barbiturates, carbamazepine, phenytoin. A Tooth discolouration, enamel hypoplasia, reduced fibula growth rate; avoid use in pregnancy and lactation unless no alternative. GI disturbances, oesophagitis. Allergic reactions. Photosensitivity. Superinfections.
XIGRIS
Lilly
2JN
Recombinant protein C. Drotrecogin alfa 2mg per ml after reconstitution. Powder for soln. for inf. Vials-5mg; 20mg plus WFI. Price available on request. S Severe sepsis with multiple organ failure when added to best standard care. P Start within 48 hrs, preferably within 24 hrs, of onset of 1st sepsis-induced organ dysfunction. 24mcg/kg/hr by continuous inf. over 96 hrs. If inf. is interrupted, restart at 24mcg/kg/hr and complete full recommended 96 hrs of dose (dose escalation or bolus dose not necessary). Inf. pump recommended. Q Under 18 years, contraindicated. D Active internal bleeding, single organ dysfunction, recent surgery, intracranial pathology, VELOSEF BMS heparin therapy r 15 international units/kg/h, 2NO severe hepatic disease, increased risk of bleeding, low platelet count Q30,000 x 106/L. Cephalosporin. Cephradine 250mg orange/blue B Recent ischaemic stroke. Monitor cap. coded SQUIBB 113. 500mg blue cap. coded haemostasis during inf. Uncontrolled or worsening SQUIBB 114. 250mg-20, A4.13; 100, A19.88; TYGACIL Wyeth 500mg-20, A8.15; 100, A39.26. coagulopathy. Possibility of allergic reactions. Pregnancy, lactation (only if essential). Contains 2NO 2NO sodium. ALSO VELOSEF SYRUP Cephradine 250mg per Tetracyclines. Tigecycline 50mg. Powder for soln C Protein C, thrombolytics, oral A 5ml; powder for susp. 100ml, 4.91. for inf. Price on request. anticoagulants, hirudins, antithrombin, aspirin, S Infections of respiratory and gastroS Complicated skin and soft tissue infections. Complicated intra-abdominal infections. intestinal tracts and of skin and soft tissues, bones other antiplatelets agents eg. NSAIDs, prostacyclins. P Initially 100mg followed by 50mg every and joints. Septicaemia, endocarditis. Prophylaxis A Risk of bleeding, serious bleeding in surgery. UTI. 12 hours for 5-14 days depending on severity, events (ecchymosis, GI tract/CNS bleeding), P 1-2g daily in 2 or 4 divided doses; max. infection site, and clinical response. Severe hepatic headache, pain. 4g daily. impairment: 25mg every 12 hours following the Q 25-50mg/kg daily in 2 or 4 divided 100mg loading dose. ZINACEF GSK doses. Otitis media: 75-100mg/kg daily in divided Q Under 18 years, not recommended. doses; max. 4 g daily. Continue in all cases for 48D Pregnancy (unless clearly 72hours after patient is asymptomatic. recommended). B Severe underlying diseases, limited data. 2 N O ALSO VELOSEF INJECTION Cephradine 500mg, 1g. Consider combination antibacterial therapy in Powder in vials. 500mg-5, A5.78; 1g-1, A2.27. severely ill patients with complicated intraP 2-4g IM, IV or IV inf. daily in divided abdominal infections secondary to clinically doses. 8g in severe infections. apparent intestinal perforation or patients with - before the brand name Q 50-100mg/kg daily in divided doses. incipient sepsis or septic shock. May occur: Severe infections, 200-300mg/kg daily. Pseudomembranous colitis, acute pancreatitis indicates a preparation which may (consider discontinuation), anaphylaxis, cholestasis B Hypersensitivity to penicillins. Renal be dispensed once only unless impairment. (monitor). May cause overgrowth of nonspecific instructions are issued to susceptible organisms. May cause permanent tooth C Loop diuretics, aminoglycosides. A Hypersensitivity reactions. GI discolouration in humans if used during tooth the contrary. development. Lactation. Driving or using machines disturbances. Rarely, pain at inj. site, candidiasis, eosinophilia, neutropenia, leucopenia, if dizziness occurs. thrombocytopenia, rise in liver enzymes and blood C Warfarin. Oral contraceptives. - before the brand name A Abscess, infections, prolonged activated urea. Positive Coomb’s test. partial thromboplastin time, prolonged indicates a preparation which in VIBRAMYCIN Pfizer prothrombin time, dizziness, phlebitis, GI the absence of specific instructions disorders, elevated AST/ALT/amylase, 2NO hyperbilirubinaemia, pruritus, rash, headache, to the contrary may be dispensed Tetracycline. Doxycycline (HCl) 50mg, 100mg. increased BUN. Green cap. marked PFIZER and Vibracina. 50mg-28, for six months only, and at such A6.01; 100mg-8, A3.26; 100mg-12, A2.93. VANCOCIN Flynn intervals over the six month period, S Pneumonia; respiratory, gastro-intestinal 2JN tract, soft tissue and ophthalmic infections. UTI. following its issue as the dispenser Glycopeptide. Vancomycin (HCl) equiv. vancomycin STD. considers appropriate, 500mg (525,000 IU). Powder for concentrate for P Usually 200mg with food or fluid on the having regard to dosage rate. soln for inf. and powder for oral soln. in vial. 1, first day then 100-200mg daily. STD, see SPC. A12.30. Q Under 12 years, not recommended.
DISPENSING RULES
1
6
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
211
8.2 ANTIFUNGAL
ANTI-INFECTIVES
DRUGS
(100mg) vials. 10, A1371.32. S 1st-line treatment of aspergillosis in immunocompromised and immunocompetent patients, systemic candidal infections in neutropenic and non-neutropenic patients. Cryptococcal meningitis and systemic cryptococcosis in patients with AIDS. Severe systemic fungal infections (fusariosis, zygomycosis, blastomycosis, histoplasmosis). V 5.0mg/kg daily as single IV infusion, at rate of 2.5mg/kg/hr. Duration: At least 14 days for severe systemic infections; safe up to 11 months. D Pregancy, lactation (no data). B Admin. test dose immediately prior to 1st inf., premedication may be admin. to prevent ZYVOX Pharmacia inf.-related ad-events. C Nephrotoxic drugs, cyclosporin (monitor 2NT renal function). Zidovudine (monitor renal and Oxazolidinone. Linezolid 600mg. White film-ctd haematologic function). ovaloid tab. marked Zyvox 600mg one side. 10, A Mild/moderate (first 2 inf.). Chills, fever, GSK A617.61. nausea, vomiting, increased BP, dyspnea. 2NT
2NO
Cephalosporin. Cefuroxime (sodium salt) 250mg, 750mg, 1.5g. Vials. (GMS)250mg (IM or IV use)-5, A5.12; (GMS)750mg (IM or IV use)-5, A15.33; 1.5g for IV inj.-1, A7.22. S Respiratory tract and soft tissue infections, serious infections pending bacteriology. Meningitis. Prophylaxis against infection in surgical procedures. UTI and gonorrhoea. V See lit. B Loop diuretics. Mild to moderate hearing loss reported in paediatric patients. C Oral contraceptives. Avoid: Dilution in Na+ bicarbonate, admixture with other medications in sln during IV admin. Interferes with tests for glycosuria depending on copper reduction. A Hypersensitivity, GI reactions. See SPC.
ZINNAT 2NO
Cephalosporin. Cefuroxime (axetil) 125mg, 250mg, 500mg. White biconvex capsule shaped film-ctd tabs. marked GXES5, GXES7 or GXEG2 resp. 125mg-14, A3.49; 250mg-14, A5.69; 500mg-14, A10.82.
years, 5ml; 8-11years, 7.5ml; 12-14 years, 10ml. All as single daily dose for 3 days taken with food. D Hepatic disease. B Renal or hepatic impairment. Pregnancy, lactation. C Ergot derivatives, antacids, cyclosporin, digoxin, warfarin, terfenadine. A GI upset, anorexia, allergic reactions, photosensitivity, arthralgia, oedema, angioneurotic oedema, anaphylaxis, abnormal liver function, hepatitis, cholestatic jaundice, dizziness, vertigo, convulsions, headache, somnolence, intestinal nephritis, acute renal failure, palpitations, arrythmias, asthenia, paraesthesia.
ALSO ZYVOX ORAL SUSPENSION Linezolid 100mg/5ml. White to light yellow orange flavoured granules. 150ml, A308.80.
2NO
ALSO ZYVOX INFUSION Linezolid 600mg per 2NO 300ml. Isotonic clear colourless to yellow soln. 10 x 300ml, A617.74. ALSO ZINNAT ORAL SUSPENSION Cefuroxime (axetil) 125mg/5ml. 70ml, A8.40. S Nosocomial pneumonia, community acquired pneumonia and complicated skin and 2NO soft tissue infections when known or suspected to ALSO ZINNAT 250MG ORAL SUSPENSION be caused by susceptible Gram positive bacteria. Cefuroxime (axetil) 250mg/5ml. 70ml, A15.11. P 600mg twice daily for 10-14 days. Max. S Otitis media. Infections of upper and duration: 28 days. Duration is dependent on lower respiratory tract e.g. tonsillitis, pharyngitis, pathogen, infection site, severity, and patient bronchitis and pneumonia. Skin and soft tissues. clinical response. Initiate in hospital, after UTI. Gonorrhoea. Prevention and treatment of consultation with relevant specialist. Combination Lyme disease. therapy necessary if concomitant Gram negative P Tabs. are best taken after food. Most pathogen suspected. infections, 250mg twice daily. Severe infections, Q Under 18 years, not recommended. 500mg twice daily. Gonorrhoea, 1g as a single dose. D Uncontrolled hypertension, Q Under 3 months, not recommended; phaeochromocytoma, carcinoid thyrotoxicosis, over 3 months, 125mg twice daily. Over 2 years bipolar depression, schizoaffective disorder, acute with otitis media or more serious infections, confusional states. Lactation. 250mg twice daily. B Complete blood counts (incl. Hb levels, B Penicillin hypersensitivity. Pregnancy, platelets, and total and differentiated leucocyte lactation. counts) should be monitored weekly. Risk of A GI disturbances. Hypersensitivity myelosuppression (including anaemia, leucopenia, reactions. Pseudomembranous colitis. Eosinophilia, pancytopenia and thrombocytopenia). Lactic transient candidiasis. Increase in liver enzymes and acidosis, pseudomembranous colitis, peripheral positive Coombâ&#x20AC;&#x2122;s test. and optic neuropathy have been reported. Severe renal or hepatic insufficiency. Pregnancy (unless ZITHROMAX Pfizer benefit outweighs risk). Sln for inf. contains 2NO glucose. Oral suspension contains aspartame Macrolide. Azithromycin (dihydrate) 250mg. White sucrose, mannitol and Na+. Driving or using machinery (if dizziness occurs). cap. marked Pfizer and ZTM 250. 4, A9.42; 6, A16.13. C Contra: MAOIs (or within 2 weeks), SSRIs, TCAs, serotonin 5-HT1 receptor agonists S Infections of upper and lower respiratory tract, skin and soft tissue. Otitis media, (triptans), sympathomimetic agents (incl. the uncomplicated genital infections due to Chlamydia adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine), vasopressive agents (e.g. trachomatis or non-multi-resistant Neissena epinephrine, norepinephrine), dopaminergic gonorrhoeae. agents (e.g. dopamine, dobutamine), pethidine, P 2 once daily for 3 days taken at least 1 hr before or 2 hrs after food. Genital infections, 4 buspirone. A Headache, candidiasis, abnormal liver as a single dose. function tests, taste perversion, diarrhoea, nausea, Q Use susp. vomiting. 2N ALSO ZITHROMAX SUSPENSION Azithromycin 8.2 ANTIFUNGAL DRUGS (dihydrate) 200mg/5ml; Powder for susp. Reconstituted in water to give cherry/banana ABELCET Cephalon flavoured susp. Powder for 15ml (with spoon + 10ml oral syringe), A5.75; Powder for 22.5ml (with 2 N spoon), A8.63. Polyene antibiotic. Amphotericin B lipid complex (ABLC) 5mg (5000 units/ml). Susp. in 20 ml Q Under 3 years (Q15kg), 10mg/kg; 3-7
212
AMBISOME
Gilead
2N Polyene antibiotic. Amphotericin B (in liposome) 50mg (50,000 units). Powder in vial. 10, A1904.60. S Treatment of systemic mycotic infections due to cryptococcus, North American blastomycosis, disseminated candidiasis, coccidioid nycosis, aspergillosis, histoplasmosis, murcormycosis and some cases of American mucocutaneous leishmaniasis. Treatment of fever of unknown origin (FUO) in neutropenic patients.Primary therapy of visceral leishmaniasis in immunocompetent patients, incl. both adults and children. P Systemic mycotic infections: 1mg/kg body weight increased to 3mg/kg as required. Fever of unknown origin: 1mg/kg/day increased to 3mg/kg/day if indicated. Visceral leishmanias: 11.5mg/kg/day for 21 days or 3mg/kg/day for 10 days. Immunocompromised; 1-1.5mg/kg/day for 21 days may be used. See SPC. B Anaphylactic reactions, serum electrolyte levels, esp. K+ and Mg++. Renal/hepatic impairment. Monitor haematopoietic and pulmonary function. Contains sucrose. C Nephrotoxic agents, corticosteroids, corticotrophin, diuretics, digitalis glycosides. Skeletal muscle relaxants, flucytosine, antineoplastic agents, leucocyte transfusions. A Hypokalaemia, hypomagnesaemia, hypocalcaemia, hyperglycaemia, hyponatraemia. Headache, tachycardia, vasodilatation, flushing, hypotension, dyspnoea, GI disorders. Abnormal liver function tests, hyperbilirubinaemia, increased alkaline phosphatase. Rash, back/chest pain. Elevated creatinine/urea. Fever, rigors.
ANCOTIL
Meda
2N Pyrimidine. Flucytosine 2.5g in 250ml. Saline inf. 5, A272.70. S Systemic infections due to Cryptococcus neoformans or Candida albicans. P See SPC. D Pregnancy. B Severe renal insufficiency-reduce dose, monitor blood levels, blood dyscrasias.
BYFLUC
Ergha
2MO Triazole. Fluconazole 50mg, 150mg. Opaque caps; 50mg, light blue cap/ white body;150mg, light
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES blue cap and body. 50mg-7, A7.54; 150mg-1, A3.19. S Genital, mucosal or systemic candidiasis. Cryptococcosis. Prevention of relapse of cryptococcal disease in AIDS patients. Prevention of fungal infections in patients with malignancy following cytotoxic chemotherapy or radiotherapy, incl. bone marrow transplant patients. Dermatomycoses resistant to 1st line therapy or where occurrence is in immunocompromised patients. P Genital candisiasis: 150mg as a single dose. Mucosal Candidiasis: Oropharyngeal, see section 12.2; other mucosal, 50mg daily for 14-30 days; may be increased to 100mg daily in unusually difficult cases. Systemic candidiasis: 400mg on 1st day followed by 200mg once daily; may be increased to 400mg once daily. Cryptococcosis: 400mg on 1st day followed by 200400mg once daily, usually for at least 6-8 weeks for cryptococcal meningitis. Prevention of relapse of cryptococcal meningitis in AIDS patients, 100200mg daily indefinitely. Prevention of candidiasis: 50-400mg once daily starting several days before onset of neutropenia, and continued for 7 days after neutrophil count q1000 cells/mm3. Dermal infections: 150mg once weekly or 50mg once daily for 2-4 weeks or up to 6 weeks for tinea pedis. Tinea versicolor, 50mg once daily for 2-4 weeks. Renal impairment: Half dose if cc 11-50ml/min, or 1 dose after each dialysis. Q Same max. dose as adults. D Pregnancy (unless essential), lactation. B Discontinue if symptoms of liver disease develop. Rash; discontinue if develops (dermal infection), or monitor closely and discontinue if bullous lesions or erythema multiforme develop (invasive/systemic infection). Long-term use. C Contra: Terfenadine (if ByFluc dose r400mg/d), cisarpide. Caution: Coumarin-type anticoagulants, sulphonylureas, HCTZ, phenytoin, rifampicin, ciclosporin, theophylline, terfenadine, astemizole or other P450 substrates, zidovudine, tacrolimus, rifabutin, benzodiazepines. A Headache, rash, GI disorders. Hepatic toxicity incl. rare cases of fatalities, elevated alkaline phosphatase, bilirubin, SGOTand SGPT.
ANTIFUNGAL DRUGS 8.2
Mucosal: Oropharyngeal, 50mg daily for 7-14 days. Others, 50mg daily, for 14-30 days; or 100mg daily in difficult cases. Tinea and dermal: 50mg once daily. Duration 2-4 weeks; tinea pedis, up to 6 weeks. Systemic: 400mg on day 1 followed by 200mg daily; max., 400mg daily. Cryptococcal: 400mg on the 1st day followed by 200-400 mg once daily; duration at least 6-8 weeks for cryptococcal meningitis. Prevention of cryptococcal relapse in AIDS, 100-200mg daily. Prevention of fungal infections in immunocompromised: 50400mg once daily based on patient’s risk. Start several days before anticipated onset of neutropenia; continue for 7 days after neutrophil count rises q1000 cells/mm3. Renal impairment, (11-50 ml/min) 100% dose on day 1, 50% thereafter (if no dialysis), or 100% after each dialysis. CANORAL Bayer HealthCare Q Over 4 weeks: Mucosal: 3mg/kg daily; 6mg/kg may be used on day 1. Systemic / 2MO cryptococcal: 6-12mg/kg daily. Prevention of Azole antifungal. Fluconazole 150mg. Opaque, fungal infections in immunocompromised: 3-12mg/ light blue hard cap. (size 1) printed CAN 150. 1, kg daily (see adult dosing); max. 400mg daily. A3.29. Neonates: 1st two weeks of life, same dosing as in S Acute or recurrent genital candidiasis older children but given every 72 hrs; max.12mg/ (candidal vaginitis, candidal balanitis). Consider kg every 72 hrs. 3rd and 4th weeks of life, same treating partners of patients. dose but given every 48 hrs; max. 12mg/kg every P 1 cap. swallowed whole. 48 hrs. Genital, in children below 16 years: Not Q Not recommended. D Pregnancy (use contraception), lactation. recommended unless no alternative. D Pregnancy, lactation. B May occur: Abnormalities in B Discontinue if liver disease, rash haematological, hepatic, renal and other biochemical function tests (particularly in AIDS and (superficial infection) or bullous lesions/erythema multiforme (systemic infection) occur. Exfolliative cancer patients); monitor for development of cutaneous reactions, toxic epidermal necrolysis more serious hepatic injury. Exfoliative cutaneous (AIDS patients). reactions (e.g. Steven-Johnson syndrome, toxic C Terfenadine or cisapride epidermal necrolysis) may rarely occur. If rash (contraindicated). Caution: Anticoagulants, develops, further fluconazole therapy not benzodiazepines, sulphonylureas, HCTZ, recommended. Anaphylaxis reported rarely. phenytoin, rifampicin, ciclosporin, theophylline, Contains lactose. zidovudine, rifabutin, tacrolimus, other substrates C Contra: Terfenadine, cisapride. Caution: of cyt P450. Coumarin anticoagulants, oral sulphonylureas, A Headache, rash, GI disorders. hydrochlorothiazide, midazolam, phenytoin , rifampicin, cyclosporin, theophylline, zidovudine, DIFLUCAN Pfizer rufabutin, tacrolimus, astemizole or other drugs 2MO metabolised by cytochrome P450. Triazole. Fluconazole 50mg, 200mg Blue/white A GI symptoms. Also reported: Dizziness, cap. and purple/white cap. Both marked FLU, cap. seizures, alopecia, exfoliative skin disorders, toxic strength and PFIZER. 50mg-7, A7.75; 200mg-7, CANCIDAS MSD epidermal necrolysis, dyspepsia, vomiting, A30.97 leucopenia, thrombocytopenia, immunological 2JN 2MO anaphylaxis (incl. angioedema, face oedema, Systemic antifungal. Caspofungin (as caspofungin ALSO DIFLUCAN ORAL SUSP. Fluconazole 50mg, pruritus), hepatic failure, hepatitis, hepatocellular acetate) 50mg , 70mg. Vial containing white to 200mg/5ml. White powder which yields an orange necrosis, jaundice, hypercholesterolaemia, off-white compact, lyophilised powder concentrate hypertriglyceridaemia, hypokalaemia and taste flavoured susp. 50mg/5ml-35ml, A19.85; 200mg/ A79.40. for soln. for infusion. 50mg-1, A537.11; 70mg-1, 5ml-35ml, perversion. A683.18. S Mucosal candidiasis. Systemic S Invasive candidiasis (adults and DIFLAZOLE Pinewood candidiasis, cryptococcosis. Prevention of fungal paediatric patients), invasive aspergillosis in adults infections in immunocompromised patients and paediatric patients refractory to/intolerant of 2 M O following cytotoxic chemotherapy, radiotherapy. Triazole. Fluconazole 50mg, 150mg, 200mg. amphotericin B or itraconazole, presumed fungal P Systemic, 400mg on first day, then 200Green-white, yellow and white capsules resp. infections (eg. Candida or Aspergillus) in febrile, 400mg once daily. Mucosal, 50mg daily for 14-30 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, neutropenic adult or paediatric patients. days; max. 100mg daily in difficult cases. P Under 80kg, 70mg on day 1, then 50mg A51.60. Prophylaxis in immunocomppromised, 50-400mg daily. Over 80kg, 70mg on day 1, then 70mg daily. S Genital candidiasis (acute or recurrent once daily starting several days before onset of Invasive candidiasis: Duration at least 14 days after vaginal candidiasis, candidal balanitis). Mucosal neutropenia. Prevention of relapse of cryptoccal candidiasis. Tinea pedis, tinea corporis, tinea cruris, meningitis, 100-200mg daily. last positive culture (consider oral therapy with tinea versicolor and dermal Candida infections. other antifungal during this time). Invasive Q Mucosal: neonates, 3mg/kg every 72 Systemic candidiasis incl. candidaemia, aspergillosis/fungal infection: Duration at least 7 hours; 2-4 weeks, 3mg/kg every 48 hours; over 4 days after resolution of symptoms. Moderate disseminated candidiasis and other forms of weeks, 3mg/kg daily. Loading dose of 6mg/kg. hepatic insufficiency: 35mg daily. invasive candidal infection. Cryptococcosis, Systemic: neonates, 6-12mg/kg every 72 hours; 2-4 R Limited treatment experience in including cryptococcal meningitis and infections of weeks, 6-12mg/kg 48 hours; over 4 weeks, 6-12mg/ patients 65 years and older. other sites (pulmonary, cutaneous). Prevention of kg daily. Prophylaxis in immunocomprimised: Q 12 months to 17 years: single 70mg/m2 relapse of cryptococcal disease in AIDS patients. neonates, 3-12mg/kg every 72 hours; 2-4 weeks, 3loading dose (not to exceed actual dose of 70mg) Prevention of fungal infections in at risk 12mg/kg every 48 hours; over 4 weeks, 3-12mg/kg immunocompromised patients. on day 1, followed by 50mg/m2 daily (not to daily. exceed actual dose of 70mg). If well tolerated but P Genital: 150mg single oral dose. 2NO inadequate response increase to 70mg/m2 D Pregnancy, lactation. Diluents containing glucose, co-infusion with other medicinals. B Mild/moderate hepatic impairment. Severe hepatic impairment (no clinical experience). C Cyclosporin (monitor liver enzymes), tacrolimus, metabolic enzyme inducers (efavirenz, nevirapine, rifampicin, dexamethasone, phenytoin, carbamazepine). A Fever, hypotension, anaemia, headache, tachycardia, inj. site reactions, chills, GI disorders, rash, pruritis, sweating, arthralgia, dyspnoea, elevated liver enzymes and creatinine, decreased Hb, haematocrit, blood albumin and serum K+, increased glucose, decreased phosphorus, increased phosphorus, and increased eosinophils.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
213
8.2 ANTIFUNGAL
ANTI-INFECTIVES
DRUGS
ALSO DIFLUCAN IV INFUSION Fluconazole 2mg/ ml. Soln. 25ml, A8.76; 100ml, A16.81. P IV inf. at a rate of 5-10ml/min. See SPC. Q Not recommended. D Pregnancy. B Impairment in hepatic, renal or haematological function, lactation. C Cisapride, terfenadine, anticoagulants, oral hypoglycaemics, phenytoin, rifampicin, benzodiazepines, cyclosporin, theophylline, tacrolimus, rifabutin. A GI disorder, headache, anaphylaxis, rash, dizziness, seizures, alopecia, exfoliative skin disorders, dyspepsia, vomiting, hepatitis, leucopenia, neutropenia, agranulocytosis, thrombocytopenia, angioedema, facial oedema, pruritus, urticaria.
cells/mm3. Renal impairment (Q 50ml/min): 50400mg/day on day 1, then 50% or 48 hours 100% thereafter (if no dialysis), or 100% after each dialysis. Fungal infections of the skin: Tinea corporis/cruris, pityriasis versicolor: 50mg once daily or 150mg once weekly for 2-4 weeks. Tinea pedis: 50mg once daily for up to 6 weeks. Q Under 16 years, not recommended except in case of no therapeutic alternative. Mucosal candidiasis: 3mg/kg daily. 6mg/kg may be used on day 1. Systemic candidal/ cryptococcal infections: 6-12mg/kg daily. Prevention of candida infections in neutropenic children: 3-12mg/kg daily depending on extent and duration of neutropenia (see adult dosing).
2MO
ALSO FLUCOL SOLUTION Fluconazole 2mg/ml. Soln for inf. in 100ml vial. 1 vial, A30.90. ECALTA Pfizer S Mycoses caused by yeast fungi (Candida and cryptococci). Prevention of deep-seated 2J (invasive) candida infections (particularly Candida Antimycotic. Anidulafungin 100mg (3.33mg/ml albicans) in patients with neutropenia after bone reconstituted soln). Powder and solvent for marrow transplantation. Relapse prophylaxis of concentrate for soln for inf. in vials. 100mg/30ml, cryptococcal meningitis in AIDS patients. A483.42. V Over 1 month of age; as per caps. S Invasive candidiasis in non-neutropenic Candida prevention after bone marrow patients. transplantation: 400mg/day continued for 7 days P Single 200mg loading dose admin. on after neutrophil count q109/L. Neonates, same Day 1, followed by 100mg daily thereafter. Duration usually at least 14 days after last positive dose as children (max. 12mg/kg) but admin. every culture. Max. inf. rate 1.1mg/min (equiv. 3ml/min). 72 hrs (1st two weeks) or 48 hrs (weeks 3 and 4). D Pregnancy. Q Under 18 years, not recommended. B Development of abnormal liver test D Hypersensitivity to other products of values (monitor closely). Proarrhythmic conditions echinocandin class. Pregnancy; lactation (consider risk/benefit). eg. QT prolongation, cardiomyopathy, sinus B Hepatic dysfunction reported. Contains bradycardia, arrhythmias. Caps. contain lactose. fructose. Lactation (use only as single 200mg dose). C Caution: Anaesthetics. C Contra: Drugs known to prolong QTA Coagulopathy, convulsion, headache, interval and metabolised by CYP3A4, eg. cisapride, nausea, GI disorders, rash, pruritus, hypokalaemia, terfenadine, astemizole, pimozide, quinidine and flushing, increased blood creatinine and hepatic halofantrine. Caution: Other substrates of CYP3A4 enzymes. or CYP2C9 (sulphonyl urea, phenytoin, losartan, celecoxib, fluvastatin, anticoagulants), HCTZ, FLUCOL Rowex rifampicin, nevirapine, amitriptyline, didanosine, theophylline, trimetrexate, zidovudine, 2MO amphotericin B. Triazole. Fluconazole 50mg, 150mg, 200mg. Hard caps. 50mg, turquoise/white; 150mg, white/white; A Skin rash, headache, GI upset, increase of AST, ALT and alkaline phosphatase. 200mg, purple/white. 50mg-7, A12.84; 150mg-1, A5.48; 200mg-7, A51.26. FUNGAFINE Teva S Mycoses caused by yeast fungi (Candida 2MO and cryptococci), incl. systemic candidiasis (eg. candidaemia, candiduria), cryptococcal meningitis, Allylamine antifungal. Terbinafine 250mg (as superficial mucosal candidiasis. Relapse prophylaxis terbinafine HCl). White, round, flat, tab., scored on both sides with side scores, marked T above of cryptococcal meningitis in AIDS patients, and 1 below score. 250mg-28, A29.50. prevention of candidiasis in patients with S Fungal infections such as tinea corporis, malignancies during chemotherapy or tinea cruris and tinea pedis. Onychomycosis (nail radiotherapy and in immunocompromised infections) caused by dermatophytes. patients. Fungal infections of the skin. P 250mg once daily. Skin infections: 2-4 P Systemic candidiasis/ cryptococcal weeks. Tinea pedis, may be up to 6 weeks. meningitis: 400mg once daily on day 1, then Onychomycosis: 6-12 weeks. Toenail infections, 200mg once daily; may be increased to 400mg usually 12 weeks but up to 6 months. Impaired once daily. Duration: Cryptococcal meningitis, 6-8 renal function (ccQ50ml/min): Half dose. weeks. Candiduria: 50mg once daily for 14-30 Q Not recommended. days. If severe, may be increased to 100mg once daily. Mucosal candidiasis: 50mg once daily for 14- D Severe hepatic or renal impairment. Pregnancy (unless clearly necessary), lactation. 30 days (oropharyngeal, 7-14 days); may be increased to 100mg once daily if severe (except for B Chronic or active liver disease (not chronic-atrophic condition). Relapse prophylaxis of recommended). Cholestasis, hepatitis may occur. Psoriasis (caution). High fever or sore throat cryptococcal meningitis: 100-200mg once daily while monitoring laboratory values. Prevention of (possible haematological reaction). C Caution: CYP2D6 substrates with narrow candidiasis: Immunocompromised, 50mg once therapeutic window, cytochrome P450 inducers daily; during chemotherapy or radiotherapy, (eg. rifampicin) and inhibitors, oral contraceptives. 400mg once daily, initiated 2-3 days prior to anticipated onset of neutropenia and continued a A Loss of appetite, headache, GI disorders, rash, urticaria. further 7 days after neutrophile number q1000
214
FUNGASIL
Clonmel
2MO Antifungal allylamine. Terbinafine (as HCl) 250mg. White, round, biconvex scored tab. marked 250. 28, A29.81. S Fungal infections such as tinea corporis, tinea cruris, tinea pedis and onychomycosis (nail infection) caused by dermatophytes. P 250mg once daily. Skin infections: 2-4 weeks; tinea pedis: Up to 6 weeks. Fingernail onychomycosis: 6 weeks. Toenail onychomycosis: 12 weeks, sometimes up to 6 months. Impaired renal function (cc Q 50ml/min): Half normal dose. Q Not recommended. D Severe renal/hepatic impairment. Pregnancy, lactation; not recommended. B Cholestasis and hepatitis rarely reported. Possible haematological reactions. Chronic or active liver disease (not recommended). Caution: Psoriasis. C Caution: Cytochrome P450 inhibitors or inducers; CYP2D6 substrates (e.g. TCAs, b-blockers, SSRIs and MAOIs), oral contraceptives. A Loss of appetite, headache, GI disorders, rash, urticaria, arthralgia, myalgia, fatigue, malaise.
FUNGIZONE
BMS
2N Polyene antibiotic. Amphotericin 50,000 IU (50mg). Powder for inj. in vial. 1, A5.07. S Cryptococcosis (torulosis); North American blastomycosis; disseminated forms of candidosis, coccidioidomycosis and histoplasmosis; mucormycosis caused by Mucor, Rhizopus, Absidia, Entomophthora, Conidiobolus, Basidiobolus sporotrichosis, aspergillosis. V Initially 0.25mg/kg by IV inf. over 2-4 hrs, gradually increasing to 1mg/kg daily. Max. 1.5mg/kg daily if severe. Other routes: See SPC. D Lactation. B Weekly blood counts and serum K+ determination. Monitor renal and hepatic function.Nephrotoxic (discontinue if serum creatinine q260mcmol/l). Children. Pregnancy (only if essential). C Nephrotoxic drugs, antineoplastics (avoid). Digitalis glycosides, anti-arrhythmic agents and skeletal muscle relaxants, corticosteroids, flucytosine, leukocyte transfusions. A Fever, headache, anorexia, weight loss, GI disorders, malaise, muscle and joint pains, dyspepsia, cramping epigastric pain, local venous pain at inj. site with phlebitis and thrombophlebitis, normochromic normocytic anaemia and hypokalaemia. Abnormal renal function.
LAMISIL
Novartis
2MO Allyamine antifungal. Terbinafine (HCl) 250mg. White scored tab. coded Lamisil 250. 14, A10.19; 28, A19.66. S Fungal infections of the skin and nails caused by Trichophyton where oral therapy is indicated. P 1 daily for 2-6 weeks in T. pedis, 2-4 weeks in T. cruris, 4 weeks in T. corporis and between 6 weeks and 3 months for finger-nail infections and 3-6 months for toe-nail infections. Q Not recommended. D Chronic, active liver disease (avoid). Pregnancy, lactation. B Signs for hepatotoxicity; discontinue
2
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c
s
b
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
8.2 ANTIFUNGAL
ANTI-INFECTIVES
DRUGS
LANAFINE 2MO
Allylamine antifungal. Terbinafine (as HCl) 250mg. Almost white, round, biconvex, scored tab. marked 250. 28, A29.14. S Fungal infections of skin caused by Trichophyton, Microsporum canis and Epidermophyton floccosum, ringworm (tinea corporis/cruris/pedis/capitis), onychomycosis (nail infections) caused by dermatophyte fungi. P 250mg once daily. Tinea pedis, 2-6 weeks; corporis, 4 weeks; cruris, 2-4 weeks. Onychmycosis: Usually 6 weeks-3 months, although some may require 6 months or longer. Renal impairment (ccQ50ml/min): Usually half normal dose. D Chronic or active liver disease. Pregnancy (unless benefit outweighs risk), lactation. B Cholestasis and hepatitis rarely reported. Monitor for signs of hepatotoxicity. Psoriasis (caution). C Caution: CYP2D6 substrates (eg. TCAs, SSRIs, b1-blockers, antiarrhythmics, MAOIs type B, antipsychotics), inhibitors/inducers of P450 enzymes (e.g. rifampicin, cimetidine). A GI symptoms, rash, urticaria, arthralgia, myalgia, headache, malaise, tiredness.
MYCAMINE
Astellas
2J Echinocandin. Micafungin (Na+), 50mg, 100mg. White compact powder for sln for inf. in vial. 50mg-1, A297.97; 100mg-1, A496.97. S Invasive candidiasis; prophylaxis of Candida infection in patients undergoing allogenic haematopoietic stem cell transplantation or patients expected to have neutropenia (Q500 cells/Âľl) for 10 days or more; oesophageal candidiasis in patients for whom IV therapy is appropriate (adults only). PI V Invasive Candidiasis: q40kg, 100mg/day. Q40kg, 2mg/kg/day. Treatment duration: 14 days minimum and at least 1 week after 2 sequential negative blood cultures and resolution of clinical signs and symptoms. Prophylaxis of Candida infection: q40kg, 50mg/day. Q40kg, 1mg/kg/day. Admin. for at least 1 week after neutrophil recovery. Oesophageal Candidiasis (adults only): q40kg, 150mg/day. Q40kg, 3mg/kg/day. Admin. for at least 1 week after resolution of clinical signs and symptoms D Pregnancy, lactation (unless clearly necessary). B Foci of altered hepatocytes and hepatocellular tumours observed in rats; carefully monitor liver function; assess risk/benefit particularly in severe liver function impairment or chronic liver diseases. Severe hepatic impairment: Insufficient data. Haemolysis and haemolytic anaemia rarely reported. Monitor renal function. Contains lactose. C Mycamine in combination with
216
risk of developing IFI. P Admin. with a meal, or nutritional suppl. in patients who cannot tolerate food. Refractory IFI/Intolerant patients with IFI: 400mg twice a day. Patients who cannot tolerate a meal/ suppl.: 200mg four times a day. Oropharyngeal Candidiasis: Loading dose of 200mg once a day on the 1st day, then 100mg once a day for 13 days. Prophylaxis of IFI: 200mg three times a day. Duration, based on recovery from neutropenia or immunosuppression. AML or MDS, start several days before onset of neutropenia and continue MYCOSTATIN ORAL BMS for 7 days after the neutrophil count q 500 cells/ mm3. 2MO Q Under 18 years, not recommended. Antifungal. Nystatin 100 000 units/ml. Ready D Lactation. mixed susp. 30ml with dropper, A2.91. B Hypersensitivity to other azoles. Severe S Oral and oesophageal candidosis. hepatic impairment. Monitor patients who V 1ml four times daily held in contact develop abnormal liver function tests. Prowith lesions. Continue for 48 hours after clinical arrhythmic conditions. Monitor for electrolyte cure to prevent relapse. disturbances. Pregnancy. B Should not be used for systemic C Contra: Terfenadine, astemizole, mycoses. Pregnancy, lactation. cisapride, pimozide, halofantrine or quinidine, A Rarely oral irritation or sensitivity, ergot alkaloids, HMG-CoA reductase inhibitors nausea. metabolised through CYP3A4. Avoid: Vinca NAILDERM Gerard alkaloids, rifabutin, rifampicin and similar inducers, phenytoin and similar anticonvulsants, efavirenz, 2MO cimetidine, H2 receptor antagonists and PPIs. Antifungal allylamine. Terbinafine (as HCl) 250mg. Caution: Medicines known to prolong the QTc White, round, biconvex scored tab. marked TF 250 interval, ciclosporin, tacrolimus, sirolimus, other and G on reverse. 14, A16.98; 28, A32.77. CYP3A4 substrates, CYP3A4 inhibitors and S Fungal infections such as tinea corporis, inducers. tinea cruris, tinea pedis and onychomycosis (nail A Neutropenia, electrolyte imbalance, infection) caused by dermatophytes. anorexia, paresthesia, dizziness, somnolence, P 250mg once daily. Skin infections: 2-4 headache, GI disorders, elevated liver function weeks; tinea pedis: Up to 6 weeks. Fingernail tests, rash, pyrexia, asthenia, fatigue. onychomycosis: 6 weeks. Toenail onychomycosis: 12 weeks, sometimes up to 6 months. Impaired SPORANOX Janssen-Cilag renal function (cc Q 50ml/min): Half normal dose. 2MO Q Not recommended. Azole antifungal. Itraconazole 100mg. blue/ D Severe renal/hepatic impairment. transparent cap. and pink body, size 0. 15, Pregnancy (unless clearly necessary), lactation. A26.04. B Cholestasis and hepatitis rarely S Onychomycosis, systemic mycoses, reported. Possible haematological reactions. Chronic or active liver disease (not recommended). pityriasis versicolor, dermatophytoses, oral candidosis. vulvovaginal candidosis. Caution: Psoriasis. C Caution: Cytochrome P450 inhibitors or P Onychomycosis, 200mg once daily for 3 inducers; CYP2D6 substrates (e.g. TCAs, b-blockers, months or 2 pulse treatments for fingernail infections or 3 pulse treatments for toenail SSRIs and MAOIs), oral contraceptives. A Loss of appetite, headache, GI disorders, infections. A pulse treatment consists of 2 caps. (200mg) twice daily for 7 days. Pulse treatments rash, urticaria, arthralgia, myalgia, fatigue, are separated by a 3-week drug-free interval. malaise. Pityriasis versicolor, 200mg once daily for 7 days. NOXAFIL Schering-Plough Tinea corporis, tinea cruris, 100mg once daily for 2 weeks. Tinea pedis, tinea manuum, 100mg once 2NT daily for 4 weeks. Fungal keratitis, 200mg once Antimycotic. Posaconazole 40mg/ml. White oral daily for 3 weeks. Oral candidosis, 100mg once suspension. 105ml, A751.55. daily for 2 weeks. Vulvovaginal candidosis 200mg S Invasive aspergillosis, fusariosis, twice daily for 1 day or 200mg once daily for 3 chromoblastomycosis, mycetoma, days. coccidioidomycosis, in adults with disease that is W Not recommended. refractory to amphotericin B, itraconazole or 2MO fluconazole or in patients who are intolerant of ALSO SPORANOX ORAL SOLUTION Itraconazole these medicines. Oropharyngeal candidiasis as 1st 10mg/ml. Soln. 150ml, A59.80. line therapy in patients who have severe disease S Oral and oesophageal candidiasis in or are immunocompromised, in whom response to HIV-positive or immunocompromised patients. topical therapy is expected to be poor. Prophylaxis Prophylaxis of deep fungal infections anticipated of invasive fungal infections (IFI) in: 1) Patients to be itraconazole-susceptible, in patients with receiving remission-induction chemotherapy for haematological malignancy or undergoing bone, acute myelogenous leukemia (AML) or marrow transplant and expected to become myelodysplastic syndromes (MDS) expected to neutropenic (when standard therapy result in prolonged neutropenia and who are at inappropriate). high risk of developing IFI; 2) Hematopoietic stem P 200mg once daily or 100mg twice daily cell transplant (HSCT) recipients who are for 1 week. Repeat if necessary. In fluconazole undergoing high-dose immunosuppressive therapy resistant patients up to 400mg daily may be taken for 2 weeks and repeated if necessary. for graft versus host disease and who are at high
sirolimus, nifedipine, itraconazole. A All patients: Leukopenia, neutropenia, anaemia, hypokalaemia, hypomagnesaemia, hypocalcaemia, headache, phlebitis, GI disorders, increased blood AP, increased AST, increased ALT, increased blood bilirubin (incl. hyperbilirubinaemia), abnormal liver function test, rash, pyrexia, rigors. Paediatric patients: Thrombocytopenia, tachycardia, hypertension, hypotension, hyperbilirubinaemia, hepatomegaly, Niche acute renal failure, increased blood urea.
and evaluate liver function. High fever or sore throat, evaluate for possible haematological reaction. Renal impairment (ccQ50ml/min). C Caution: P450 inhibitors or inducers (eg. cimetidine, rifampicin), CYP2D6 substrates (eg. TCAs, b-blockers, SSRIs, antiarrhythmics class IC, MAO-Is Type B), caffeine, desipramine, ciclosporin. A Headache, GI disorders, rash, urticaria, arthralgia, myalgia.
2
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c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTITUBERCULOUS AND
ANTILEPROTIC DRUGS
8.3
and evaluate liver function. High fever or sore throat, evaluate for possible haematological reaction. C Caution: P450 inhibitors or inducers (eg. cimetidine, rifampicin), CYP2D6 substrates (eg. TCAs, b-blockers, SSRIs, antiarrhythmics class IC, MAO-Is Type B), caffeine, desipramine, ciclosporin. A Headache, GI disorders, rash, urticaria, arthralgia, myalgia.
events, dermatological reactions. Proarrhythmic conditions (caution). Women of child-bearing potential must use effective contraception. ALSO SPORANOX IV Itraconazole 10mg/ml + Prolonged visual disturbances may occur. Driving/ (diluted, 3.33mg/ml). Contains Na . Conc. for soln. using machinery. Contains lactose (tab.), sucrose for inf. 25ml, A104.25. (oral soln.). S Treatment of histoplasmosis. Systemic C Contra: Tefenadine, astemizole, aspergillosis, candidosis, cryptococcosis (incl. st cisapride, pimozide, quinidine, rifampicin, cryptococcal meningitis) when 1 -line therapy carbamazepine, phenobarbital, ergot alkaloids inappropriate. (ergotamine, dihydroergotamine), P Loading: 200mg as 1-hour inf. Initial Rowex sirolimus,efavirenz, ritonavir (r400mg twice daily). loading dose, twice daily (2 days); then once daily; TERNAF Caution: Astemizole, cyclosporin, tacrolimus, max. 14 days. Renal impairment: Moderate, 2MO warfarin, oral anticoagulants, sulphonylureas, consider dose adjustment; severe, not Allylamine antifungal. Terbinafine 250mg (as statins, benzodiazepines, vinca alkaloids, recommended. terbinafine HCl). White, round, scored, convex phenytoin, rifabutin, methadone, omeprazole, HIV R If benefit outweighs risk. tabs. marked TER 250. 28, A32.72. Q Do not use unless benefit outweighs S Fungal infections such as tinea corporis, protease inhibitors (other than indinavir), nonNRTIs. risk. tinea cruris and tinea pedis. Onychomycosis (nail A Headache, asthenia, flu syndrome, back/ D Pregnancy-contraception must be used infections) caused by dermatophytes. chest pain, oedema, hypotension, phlebitis, GI during, and for one menstrual cycle after P 250mg once daily. Skin infections: 2-4 disorders, elevated liver function, jaundice, treatment. Lactation. weeks. Tinea pedis, may be up to 6 weeks. cheilitis, gastroenteritis, haemic and lymphatic B CHF or history of: Use only if benefit Onychomycosis: 6 weeks-3 months. Toenail outweighs risks. CHF risk increases with total daily infections, usually 3 months; sometimes 6 months disorders, haematuria, hypokalaemia, creatinine increased, hypoglycaemia, dizziness, hallucinations, dose. Transient LV ejection fraction may occur. or longer. Impaired renal function (ccQ50ml/min): confusion, depression, anxiety, tremor, Caution: Hepatic, renal impairment. Monitor liver Half dose. paraesthesia, respiratory distress syndrome, function, patient should report signs of hepatitis; Q Under 18 years, not recommended. sinusitis, skin reactions, alopecia, visual if occurs stop immediately. Discontinue if D Severe hepatic/renal impairment. disturbances (incl. blurred vision chromatopsia and neuropathy occurs. Oral solution not Pregnancy (unless essential), lactation. photophobia), acute kidney failure, altered taste recommended for severe neutropenia. Transient or B Chronic/active liver disease (not perception (oral soln.). permanent hearing loss may occur. Not recommended). Cholestasis, hepatitis may occur. recommended: Fructose intolerance, glucosePsoriasis. Cutaneous disorders. Discontinue if high 8.3 ANTITUBERCULOUS AND galactose malabsorption, sucrase-isomaltase fever or sore throat. insufficiency. C Caution: CYP2D6 substrates with narrow ANTILEPROTIC DRUGS C Contraindicated: Astemizole, bepridil, therapeutic window, eg. metoprolol, RIFADIN sanofi-aventis cisapride, dofetilide, levacetylmethadol antiarrhythmics. Cytochrome P450 inducers (eg. (levomethadyl), mizolastine, pimozide, quinidine, 2NO rifampicin). sertindole, terfenadine, CYP3A4 metabolized A Decreased appetite, headache, GI Rifamycin. Rifampicin 150mg, 300mg Resp. blue/ HMG-CoA reductase inhibitors (e.g. atorvastatin, disorders, rash, urticaria. red cap and red cap. 150mg-100, A22.16; 300mglovastatin, simvastatin), triazolam, oral midazolam, 100, A44.32. ergot alkaloids (e.g. dihydroergotamine, VFEND Pfizer 2 N O ergometrine, ergotamine, methylergometrine), 2NT ALSO RIFADIN ORAL SUSPENSION Rifampicin eletriptan, nisoldipine. Caution: CYP3A4 100mg per 5ml. 120ml, A4.28 Triazole antimycotic. Voriconazole 200mg, 50mg. metabolised calcium channel blockers (e.g. S Tuberculosis. Certain mycobacterial White, round tab. marked Pfizer on one side, dihydropyridines, verapamil), oral anticoagulants, VOR50 on reverse. White, cap.-shaped tab. marked infections. Gram positive organisms. N. HIV protease inhibitors (ritonavir, indinavir, gonorrhoea. Pfizer on one side, VOR200 on reverse. 50mg-28, saquinavir), busulfan, docetaxel, trimetrexate, A484.40; 200mg-28, A1932.00. P 450-600mg daily (10mg/kg). Impaired vinca alkaloids, ciclosporin, tacrolimus, rapamycin liver function, 8mg/kg. All as a single dose 30 min 2JN (sirolimus), budesonide, dexamethasone, before or 2 hrs after food. ALSO VFEND INFUSION Voriconazole 200mg. fluticasone and methylprednisolone, digoxin , Q 10-20 mg/kg daily (max. 600mg) as a White lyophilised powder in a 30ml clear glass cilostazol, disopyramide, carbamazepine, single dose. Under 2 yrs, not recommended. vial. 1 x 30ml, A153.00. buspirone, alfentanil, alprazolam, brotizolam, D Jaundice. Concurrent use with 2JN midazolam IV, rifabutin , ebastine, repaglinide, ALSO VFEND ORAL SUSPENSION Voriconazole 40 saquinavir/ritonavir combination. fentanyl, reboxetine, halofantrine, loperamide. B Impaired liver function, mg/ml. White to off white powder for oral A Hypokalemia, headache, dizziness, hyperbilirubinaemia. Hypersensitivity and suspension. Orange flavoured suspension when nausea, GI disturbances, hepatitis, jaundice, anaphylaxis (avoid dosage interruption). Elderly. reconstituted. 75ml, A760.64. hyperbilirubinaemia, increased hepatic enzymes, Malnourished. Porphyria. Reddish colouration of rash, pruritus, oedema. S Treatment of invasive aspergillosis, tears, urine, sweat and sputum. Pregnancy, fluconazole-resistant serious invasive Candida lactation. TERBASIL Actavis infections (incl. Candida krusei), serious fungal C All drugs metabolised by cytochrome infections caused by Scedosporium spp. and 2MO P450 enzyme system, especially CYP 3A4. Others: Fusarium spp. Admin. primarily to Allylamine antifungal. Terbinafine (HCl) 250mg. atovaquone, antacids, certain contrast media, immunocompromised patients with progressive, White scored tab. marked T above and 1 below enalapril, halothane, isoniazid, ketoconazole, oral possibly life-threatening infections. score. 28, A30.96. contraceptives, p-aminosalicyclic acid. P Infusion: Loading dose, 6mg/kg 12 S Fungal infections of the skin and nails A Skin reactions. GI reactions incl. caused by Trichophyton, M. canis and E. floccosum hourly (1st 24 hrs); maintenance, 4mg/kg twice pseudomembranous colitis. Hepatitis. daily. Other: Over 40kg body weight, loading where oral therapy is indicated. Thrombocytopenia. Cerebral haemorrhage. dose, 400mg 12 hourly (1st 24 hrs); maintenance P 1 daily for 2-6 weeks in T. pedis, 2-4 200mg (5ml) twice daily. Under 40kg body weight, Eosinophilia, leucopenia. Oedema, muscle weeks in T. cruris, 4 weeks in T. corporis and weakness, myopathy, acute haemolytic anaemia. loading dose 200mg (5ml) 12 hourly (1st 24 hrs); between 6 weeks and 3 months (sometimes 6 Flu syndrome, shortness of breath/wheezing, maintenance 100mg (2.5ml) twice daily. months) for onychomycosis. Impaired renal Q Under 2 years, not recommended. Over hypotension and shock. Acute renal failure. function (cc Q 50ml/min): Half dose. Disturbances of menstrual cycle. 2 years, 7mg/kg twice daily inf. or 200mg (5ml) Q Not recommended. twice daily; Over 12 years, as per adults. D Chronic, active liver disease (avoid). RIFATER sanofi-aventis D Pregnancy, lactation. Lactation, pregnancy (unless benefit outweighs 2NO B Inf. related reactions, hepatic toxicity, risk). B Signs for hepatotoxicity; discontinue monitor hepatic and renal function. Renal adverse Isonicotinic acid deriv./nicotinic acid deriv./ W Not recommended.
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
217
8.4 ANTIMALARIAL
ANTI-INFECTIVES
DRUGS syndrome, shortness of breath/wheezing, hypotension and shock. Acute renal failure. Pancreatitis, nausea, vomiting. Pellagra, systemic lupus erythematosus-like syndrome. Polyneuritis and other neurotoxic effects. Disturbances of menstrual cycle.
malaria. Especially recommended where pathogen may be resistant to other antimalarials. P Take with food or a milky drink at same time each day. Prophylaxis: 1 daily, starting 24 or 48 hours prior to entering malaria-endemic area and continuing up to 7 days after leaving area. Stay should not exceed 28 days. Under 40kg, not 8.4 ANTIMALARIAL DRUGS recommended for prophylaxis. Treatment: 4 as single dose for 3 consecutive days. BY-MYCIN Ergha Q Treatment: 11-20kg, 1 daily for 3 2NO consecutive days; 21-30kg, 2 as single dose for 3 Tetracycline. Doxycycline (hyclate) 100mg. Opaque consecutive days; 31-40kg, 3 as single dose for 3 consecutive days; q 40kg, as per adults; Q11kg, dark blue/white cap. 8, A1.87. not recommended. S Prophylaxis and treatment of D Prophylaxis if severe renal impairment chloroquine-resistant falciparum malaria. (ccQ30ml/min). Lactation. P Treatment: 200mg daily for at least 7 B Acute malaria with diarrhoea or days in conjunction with a rapid-acting vomiting, severe renal impairment; consider schizonticide (e.g. quinine). Prophylaxis: 100mg alternative for treatment. Severe allergic reactions daily 1-2 days before travelling to malarious area. Continue during travel and for 4 weeks thereafter. reported. Driving/using machines. Pregnancy (if benefit outweighs risk). Q Not recommended. C Avoid rifampicin or rifabutin. Caution: D Pregnancy, lactation. Obstructive Indinavir, metoclopramide, tetracycline, coumarin oesophageal disorders. B Hepatic impairment. Oesophageal reflux anticoagulants. A Anaemia, neutropenia, allergic reactions disorders. Take with plenty of water and remain (rash), hyponatraemia, anorexia, abnormal dreams, upright. Prolonged use. C Penicillin (avoid), methoxyflurane (fatal depression, headache, insomnia, dizziness, GI disorders, elevated liver enzymes, fever, cough. renal toxicity). Antacids, Ca++, iron, coumarin anticoagulants, barbiturates, carbamazepine, QUININE SULPHATE Actavis phenytoin. A Tooth discolouration, enamel 2MO hypoplasia, GI disturbances, oesophagitis, allergic Blood schizontocide. Quinine sulphate 300mg. reactions, photosensitivity, superinfections. White, circular sug-ctd tab. marked QD and C on one side. 28, A8.41. LARIAM Roche S Malignant tertian malaria, incl. 2MO treatment of chloroquine-resistant malaria. 4-aminoquinoline. Mefloquine (HCl) 250mg. P 600mg eight hourly for 7 days. Quarter scored white tab. 8, A16.13. Q Under 12 years, 10mg/kg BW eight S Therapy and prophylaxis of malaria. hourly for 7 days. D Red blood cell enzyme deficiencies, RIFINAH sanofi-aventis Especially P. falciparum malaria resistant to other antimalarial agents. Hburia, optic neuritis, tinnitus, fructose 2NO V Prophylaxis: Over 45kg, 1 tab. weekly intolerance, glucose-galactose malabsorption or Rifamycin/isonicotinic acid. ’150’-rifampicin 150mg, started at least 1 week and up to 2-3 weeks sucrase-isomaltase insufficiency. isoniazid 100mg; pink tab. coded RH 150. ’300’before travel; 31-45 kg, x tab; 20-30 kg, v tab. 5B Caution: Atrial fibrillation or other rifampicin 300mg, isoniazid 150mg. Orange 19 kg, t tab; under 5 kg, not recommended. serious heart disease, myasthenia gravis, glucose-6oblong tab. coded RH300. ’150’-84, A19.22; ’300’- Continue during travel and 4 weeks after (min. 6 phospate dehydrogenase deficiency, inadequately 56, A25.44. weeks). Max. 12 months. Treatment based on control malarial infection. Driving, operating S Tuberculosis and other mycobacterial body weight (see SPC). machinery. Pregnancy, lactation. infections. D When for prophylaxis: Renal or hepatic C Amiodarone, flecainide, quinidine, P 450-600mg rifampicin (10mg/kg) daily impairment, history of psychiatric disturbances or anticoagulants, terfenadine, other anti-malarial combined with 5mg/kg isoniazid. Impaired liver convulsions, pregnancy, lactation. (chloroquine, artemether with lumefantrine, function: 8mg/kg/day. All as a single dose 30 mins. B Contraceptive measures should be taken mefloquine), pimozide or thioridazine, cardiac before or 2 hrs after food. by women of child-bearing age during therapy glycosides, cimetidine. Q Not recommended. and for 3 months after. Epilepsy (increased risk of A Blood disorders, hypersensitivity D Jaundice. Concurrent use with convulsions). Cardiac conduction disorders. reactions, acute renal failure, hypoglycaemia, saquinavir/ritonavir combination or paraC Delay admin. for at least 12 hours after cardiovascular effects, cinchonism (tinnitus, aminosalicyclic acid. Psychosis. quinine or related compounds. Na+ valproate, headache, nausea, abdominal pain, flushing, rash, B Impaired renal or hepatic function. typhoid vaccination. visual disturbance, confusion), muscle weakness, Chronic alcoholism. Hyperbilirubinaemia. Hepatitis. A Nausea, vomiting, GI upset, loss of deafness, vomiting, pruritis, excitement. Immunological reactions with intermittent or appetite, rarely headache, dizziness, alertness may interrupted therapy. Elderly. Slow aceylators. VIBRAMYCIN Pfizer be impaired, loss of balance, somnolence, sleep Malnourished. Porphyria. Convulsion disorders. disorders. Depression, anxiety, confusion, 2NO Reddish colouration of tears, urine, sweat and Tetracycline. Doxycycline (HCl) 50mg, 100mg. sputum. Tyramine and histamine containing foods. hallucinations, panic attacks-seek medical advice before next dose. Bradycardia, severe skin Green cap. marked PFIZER and Vibracina. 50mg-28, Pregnancy,lactation. reactions (erythema multiforme, Stevens-Johnson A6.01; 100mg-8, A3.26; 100mg-12, A2.93. C All drugs metabolised by cytochrome syndrome; discontinue immediately). S Chloroquine-resistant falciparum P450 enzyme system, especially CYP 3A4. Others: atovaquone, antacids, carbamazepine, certain malaria. MALARONE GSK contrast media, enalapril, halothane, isoniazid, P Treatment: 200mg daily for at least 7 2NO ketoconazole, oral contraceptives, phenytoin. days in conjonction with rapid-acting schizonticide Blood schizonticide. Atovaquone 250mg, proguanil such as quinine. Prophylaxis: 100mg daily in A Skin reactions. GI reactions incl. (HCl) 100mg. Round, biconvex, pink film-ctd tab. pseudomembranous colitis. Thrombocytopenia. adults. Can begin 1-2 days before travel to 12, A29.22. Cerebral haemorrhage. Eosinophilia, leucopenia, malarious areas; continue daily during travel and agranulocytosis. Oedema, muscle weakness, for 4 weeks thereafter. S Prophylaxis of P. falciparum malaria. myopathy, acute haemolytic anaemia. Flu Q Under 12 years, contraindicated. Treatment of acute, uncomplicated P. falciparum rifamycin. Isoniazid 50mg, pyrazinamide 300mg, rifampicin 120mg Light pink sug-ctd tab. 100, A25.49. S Treatment of pulmonary tuberculosis. P Over 65kg, 6 tablets daily; 50-64kg, 5 daily; 40-49kg, 4 daily; under 40kg, 3 daily. Single daily dose 1-2 hrs before a meal for 2 months. Q Not recommended. D Jaundice and hepatic disease. Concurrent use with saquinavir/ritonavir combination. Pregnancy, lactation. B Impaired liver function, hyperbilirubinaemia, hepatitis. Elderly or malnourished patients. Slow aceylators. Anaphylaxis (avoid dosage interruption). Gout. Renal insufficiency. Diabetes mellitus, alcoholism, convulsive disorders, manic or hypomanic psychosis. Haemoptysis. Reddish colouration of tears, urine, sweat and sputum. Tyramine and histamine containing foods. Pregnancy, lactation. C All drugs metabolised by cytochrome P450 enzyme system, especially CYP 3A4. Others: atovaquone, antacids, certain contrast media, enalapril, halothane, ketoconazole, oral contraceptives, p-aminosalicyclic acid. A Skin reactions. Gastrointestinal reactions, including Pseudomembranous colitis. Thrombocytopenia. Cerebral haemorrhage. Eosinophilia, leucopenia, agranulocytosis. Oedema, muscle weakness, myopathy, acute haemolytic anaemia. Flu syndrome, shortness of breath/ wheezing, hypotension and shock. Acute renal failure. Arthralagia. Anorexia, nausea, vomiting. Aggravation of peptic ulcer. Fever. Polyneuritis and other neurotoxic effects. Rash, acne, StevensJohnson syndrome, exfoliative dermatitis, pemphigoid reactions, pellagra, systemic lupus erythematosus-like syndrome, sideroblastic anaemia. Disturbances of menstrual cycle.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIMALARIAL DRUGS 8.4
MALARIA GENERAL CONSIDERATIONS Malaria, a common life-threatening disease in many tropical/subtropical areas is currently endemic in over 100 countries. Approximately half of the world's population is at risk of malaria, which in 2006 affected 247 million people, causing about 880,000 deaths, mostly among African children. Travellers from malaria-free areas to disease "hot spots" are especially vulnerable to the disease. Malaria is preventable and curable. Transmission: Human malaria is caused by infection by one of four species of the protozoan parasite Plasmodium (P. falciparum, P. vivax, P. ovale, P. malariae). P. falciparum causes falciparum (malignant tertian or subtertian) malaria, the most serious form and can be rapidly fatal. Malarias caused by the other three species are often termed ‘benign’. The malaria parasite is transmitted by various species of Anopheles mosquitoes, which bite mainly between sunset and sunrAise. Clinical Manifestation: Malaria, an acute febrile illness, has an incubation period of 7 days or longer (usually 10-20 days for P. vivax, 12-14 days for P. falciparum, and about 1 month for P. malariae.) Malaria is often atypical in those who have taken chemoprophylaxis (incubation period may extend weeks after drug completion, instead of periodic chills and fever, headache, backache, irregular fever may be experienced and parasites difficult to find in blood samples). Generally the symptoms are varied/non-specific but commonly include fever, fatigue, malaise, headache, myalgia, jaundice, splenomegaly, hepatomegaly, malarial paroxysm, anaemia and sweating. In falciparum malaria clinical features include chills, muscular aching/weakness, vomiting, cough, diarrhoea, abdominal pain, symptoms of organ failure, coma and death. It may be easily misdiagnosed as ‘viral illness’, ‘gastroenteritis’ or ‘flu’. The possibility of falciparum malaria should always be considered. Antimalarial Drugs: Antimalarial drugs include drugs used for causal prophylaxis (act on primary tissue forms of plasmodia in the liver preventing erythrocyte invasion). Drugs used to prevent relapse (act on latent tissues forms remaining after primary hepatic forms have been released in the circulation). Drugs used for clinical and suppressive cure (act on asexual erythrocytic stages, interrupt erythrocytic schizogony and terminate clinical attacks). No one available agent can reliably effect a radical cure (eliminating both hepatic and erythrocytic stages). MALARIA PROPHYLAXIS Successful malaria prophylaxis depends on drug choice, adequate counselling – the traveller should be aware of risk, incubation period, and main symptoms to ensure understanding of the need for compliance – and the need to take adequate measures to prevent mosquito bites, especially between dusk and dawn. WHO recommends measures to prevent mosquito bites including application of insect repellent to exposed skin between dusk and dawn, long clothing to cover skin, use of insecticide-treated mosquito nets at night, anti-mosquito sprays to kill mosquitoes that rest on the walls and roofs of houses. When prescribing antimalarial drugs, the following should be considered: • Correct dosage of most appropriate antimalarial drug(s) based on destination • Antimalarials taken daily should be started 1-2 days before entering risk area • Weekly chloroquine should be started 1 week before entering risk area • Mefloquine should be started at least 1 week (preferably 2-3 weeks before departure), to provide optimal protective blood levels and allow any side-effects to be detected before travel • Antimalarial drugs must be taken with food and swallowed with plenty of water • All prophylactic drugs should be taken regularly for the duration of the stay in the risk area and continued for 4 weeks after last possible exposure to infection or for 7 days in the case of atovaquone plus proguanil • No antimalarial prophylactic regimen provides complete protection • Precautions to avoid mosquito bites are necessary even when antimalarial drugs are taken Recommended Prophylaxis: Depends on the area. Chloroquine (Avloclor*) on its own is recommended only for areas where malaria is due exclusively to P. vivax or to fully chloroquine-sensitive P. falciparum. Chloroquine + proguanil (Avloclor* + Paludrine*) combination is recommended in areas with risk of P. vivax and P. falciparum malaria transmission combined with emerging chloroquine resistance. In areas with risk of P. falciparum malaria where drug resistance is reported, mefloquine (Lariam), atovaquone + proguanil (Malarone) or doxycycline (ByMycin, Vibramycin) should be used. Atovaquone + proguanil combination is especially recommended for the prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials. * licensed product not available in Ireland
Side effects: Any traveller developing serious side effects to an antimalarial should stop taking the drug and seek immediate medical attention especially neurological or psychological disturbances (mefloquine) and rashes (sulfadoxine–pyrimethamine). Malaria is not present in all tropical countries. Because of the risk of adverse side effects, chemoprophylaxis should not be prescribed in the absence of malaria risk. Malaria Prophylaxis in Pregnancy: Pregnant women and young children are particularly susceptible to severe/complicated falciparum malaria. Malaria in pregnant travellers increases the risk of maternal death, miscarriage, stillbirth and neonatal death. Drug choice for prophylaxis during pregnancy is limited and if possible pregnant/likely to become pregnant women should avoid travelling to malaria areas. Nursing mothers should not breast-feed while taking mefloquine or atovaquone-proguanil. For other antimalarials it is generally accepted that the amount consumed by nursing infants is too small to be harmful but insufficient to provide protection. DIAGNOSIS AND TREATMENT Diagnosis: Travellers should immediately seek diagnosis and treatment if a fever develops one week or more after entering an endemic area. Fever occurring in a traveller within 2-3 months of leaving a malaria-endemic area should be treated as a medical emergency (includes travellers who took chemoprophylaxis, air crews, travellers briefly exposed at airports in endemic zones). • Malaria should be suspected and confirmed by laboratory diagnosis in all febrile patients. • Definitive diagnosis depends upon the demonstration of parasites in stained blood films but antimalarial drugs should not be withheld in the absence of positive blood films if a clinical suspicion of malaria exists. Stand-by Emergency Treatment: Most travellers, should they experience fever, are able to obtain medical attention within 24 hours of the onset. However, should they be staying in a remote location, travellers may be advised to carry antimalarial drugs for self-administration (‘stand-by emergency treatment’). Malaria Treatment: Prompt diagnosis and effective treatment are crucial. Treatment is with a blood schizontocide. With vivax and ovale malarias, subsequent treatment with tissue schizontocides is needed to prevent relapse. Almost worldwide P. falciparum is chloroquine resistant. The treatment of choice for uncomplicated chloroquine-resistant falciparum malaria is a combination of two or more antimalarials with different mechanisms of action. Treatment options include: • Oral quinine sulphate + doxycycline (By-Mycin, Vibramycin) – or quinine sulphate + clindamycin (Dalacin C) in certain circumstances. • Atovaquone + proguanil (Malarone) • Mefloquine (Lariam) – keeping in mind side effects and high rate of non-completion of courses In any one country, treatment will depend on the products available in that country. Malaria should always be managed in consultation with someone experienced in managing the disease.
References available on request. Revised March 2009
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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8.5 ANTHELMINTIC
ANTI-INFECTIVES
AND AMOEBICIDE DRUGS
D Latter half of pregnancy. Lactation. B Hepatic impairment. C Antacids, mineral suppl., barbiturates, carbamazepine, phenytoin. A Tooth discolouration, enamel hypoplasia, reduced fibula growth rate; avoid use in pregnancy and lactation unless no alternative. GI disturbances, oesophagitis. Allergic reactions. Photosensitivity. Superinfections.
VERMOX
McNeil Healthcare
2O Anthelmintic. Mebendazole 100mg/5ml. Susp. 30ml, A2.11.
2OY
ALSO VERMOX TABLETS Mebendazole 100mg. Faintly orange, circular tab. marked ME100 one side, Janssen on reverse. 6, A1.83. S GI infestations caused by nematodes 8.5 ANTHELMINTIC AND AMOEBICIDE and cestodes. P Ascariasis, trichuriasis, ankylostomiasis, DRUGS mixed infections: 100mg twice daily for 3 days. FLAGYL sanofi-aventis Enterobiasis: Single 100mg dose repeated at 2-4 weeks. Taeniasis, strongyloidiasis: 200mg twice 2MO daily for 3 days. Nitromidazole. Anti-protozoal. Amoebicide. Q Under 2 years, not recommended. Over Metronidazole 200mg, 400mg Off-white film-ctd 2 years, as per adult except taeniasis, tab. and off-white cap. shaped film-coated tab. Both marked with name and strength. 200mg-21, strongyloidiasis: 100mg twice daily for 3 days. D Pregnancy, lactation. A1.00; 250, A11.79; 400mg-14, A1.41; 100, B High parasitic burdens. A10.04. C Metronidazole. Caution: Cimetidine. 2MO
fluticasone or other glucocorticoids that are metabolised by CYP3A4, atorvastatin, omeprazole, esomeprazole other PPIs.Caution: carbamazepine, phenobarbital, and phenytoin. See SPC A Hypertriglyceridaemia, hyperlipidaemia, anorexia, headache, GI disorders, rash, pruritus, fatigue.
ATRIPLA
Gilead/BMS
2J
Combination antiretroviral. Efavirenz 600mg, emtricitabine 200mg, tenofovir disoproxil (as fumarate) 245mg. Pink, capsule shaped, film-ctd tablet, marked 123. 30, A1028.02. S HIV-1 infection in adults with virologic suppression to HIV-1 RNA levels Q 50 copies/ml for over 3months. P 1 tab. once daily on empty stomach, at bedtime. Co-administration with rifampicin: Add 200mg/day (800mg total) efavirenz. Moderatesevere renal impairment (cc Q50ml/min): Not recommended. Q Under 18 years, not recommended. ALSO FLAGYL-S ORAL SUSPENSION 8.6 ANTIVIRAL DRUGS D Severe hepatic impairment (CPT grade Metronidazole benzoate 200mg/5ml. Susp. 100ml, A6.17. APTIVUS Boehringer Ing. C). Pregnancy (unless clearly necessary), lactation. B Risk of lactic acidosis (discontinue if S Infections due to E. histolytica or G. 2JN symptomatic hyperlactataemia and metabolic/lactic lamblia (including carrier states). Protease inhibitor. Tipranavir 250mg. Pink cap. acidosis, progressive hepatomegaly, or rapidly P E. histolytica: 1200-2400mg daily in 3 A725.00. marked TPV 250. 120, elevating aminotransferase levels occur). Caution: divided doses for 5-10 days. G. lamblia: 2000mg S Co-administered with low dose Mild-to-moderate liver disease, pre-existing liver once daily for 3 days. ritonavir, HIV-1 infection in highly pre-treated dysfunction incl. chronic active hepatitis, chronic Q E. histolytica: Over 10 years, as adult. 7adults with virus resistant to multiple protease HBV or HCV co-infection (increased risk of serious 10 years, 600-1200mg daily in 3 divided doses. 3-7 inhibitors. hepatic reactions), history of seizures. Prior history years, 400-800mg daily in 4 divided doses. 1-3 P 500mg (taken with 200mg ritonavir) of psychiatric disorders. Reported: Renal failure/ years, 300-600mg daily in 3 divided doses. All for twice daily with food. impairment, elevated creatinine, 5-10 days. G. lamblia: Over 10 years, as per adult. Q Not recommended. hypophosphataemia and proximal tubulopathy; 7-10 years, 1000mg once daily. 3-7 years, 600mg 2 J N monitor renal function. Discontinue if severe rash once daily. 1-3 years, 400-500mg once daily. All for ALSO APTIVUS ORAL SOLUTION Tipranavir associated with blistering, desquamation, mucosal 3 days. A involvement or fever occurs. May occur: D Active or chronic severe Peripheral and 100mg/ml. Clear yellow viscous liquid. 229.59. S Co-administered with low dose Mitochondrial dysfunction in child exposed in Central Nervous System diseases. ritonavir, HIV-1 infection in highly pre-treated utero and/or postnatally, liposdystrophy, immune B Peripheral or central neuropathy. children from 2-12 years with virus resistant to reactivation syndrome, osteonecrosis. Contains Leucopenia. Transient epileptiform seizures. multiple protease inhibitors. Only for patients with Na+. Monitor during prolonged use. Hepatic no other therapeutic options. C Contra: Terfenadine, astemizole, insufficiency or encephalopathy. Alcohol. Removed cisapride, midazolam, triazolam, pimozide, during haemodialysis. Fructose intolerance. Elderly. Q Under2 2 years, not recommended. 2-12 2 years: 375mg/m co-administered with 150mg/m bepridil, ergot alkaloids St. Johnâ&#x20AC;&#x2122;s wort, Darkens urine. Pregnancy, lactation. ritonavir, twice daily. Max dose 500mg/200mg. See voriconazole, cytidine analogues (e.g. lamivudine), C Phenytoin, phenobarbital, SPC. adefovir dipivoxil. anticoagulants, disulfiram, lithium, cyclosporin, 5D Moderate or severe hepatic impairment. Not recommended: Atazanavir/ritonavir, fluorouracil, busulfan. B Monitor hepatic tests prior to therapy, didanosine, renally eliminated drugs (e.g. A GI distress, furred tongue, unpleasant after 2, 4 and then every 4 weeks until 24 weeks, cidofovir), nephrotoxic drugs (e.g. taste. Rash, urticaria, flushing, angioedema, CNS and every 8-12 weeks thereafter. Mild hepatic aminoglycosides, amphotericin B, foscarnet, disturbances, headache, dizziness, confusion, impairment, chronic hepatitis B or C (use only if ganciclovir, pentamidine, vancomycin, interleukinhallucinations, vision and blood disorders. benefits outweigh risks), elevated ASAT and ALAT 2). See SPC. levels, other liver disease; increase monitoring. A Anorexia, nightmare, depression, METRONIDE Clonmel ASAT/ALAT q 5X ULN, do not initiate; if q10X depressed mood, anxiety, insomnia, mood altered, 2MO ULN, discontinue. Risk of clinical hepatitis and abnormal dreams, sleep disorder, dizziness, Amoebicide. Metronidazole 200mg. White scored hepatic decompensation. Caution: Elderly, somnolence, headache, hot flush, GI disorders, tab. coded MZL 200 and white scored tab. coded haemophiliacs, patients at risk of increased rash, night sweats, increased blood creatinine, MZL 400. Both marked with twin triangle logo on bleeding. Risk of lipodystrophy, osteonecrosis, fatigue, increased energy. reverse. 200mg-21, A1.62. diabetes mellitus, hyperglycaemia or exacerbations of existing diabetes mellitus, immune reaction S All forms of amoebiasis. BARACLUDE BMS syndrome. Hepatic, triglyceride and cholesterol P 1200-2400mg daily in 3 divided doses. 2NT testing, prior to treatment and regularly Q 1-3 years, 300-600mg daily in three Nucleoside analogue. Entecavir (as monohydrate) thereafter. Rashes may occur. Patients using divided doses; 3-7 years, 400-800mg daily in four 0.5mg, 1mg. White/pink triangular-shaped film-ctd oestrogens as HRT, monitor for oestrogen divided doses, 7-10 years, 600-1200mg daily in tab. with BMS debossed on one side and 1611/ deficiency. Tab. contain sorbitol and small amount three divided doses, over 10 years, as for adults. 1612 resp. on the other. Price on request. of alcohol. Treatment is usually continued for 5-10 days. 2NT C Contra: Rifampicin, St Johnâ&#x20AC;&#x2122;s wort, B Pregnancy, lactation, liver disease. ALSO BARACLUDE ORAL SOLUTION Entecavir (as substances highly dependent on CYP3A/CYP2D6 C Alcohol, oral anticoagulants and monohydrate) 0.05mg/ml. Oral sln. Price available for clearance such as antiarrhythmics, phenobarbitone. Cimetidine, lithium. on request. antihistamines, ergot derivatives, GI motility A GI distress, furred tongue, unpleasant agents, neuroleptics, sedatives/hypnotics, taste. Urticaria, angioedema, CNS disturbances, S Chronic hepatitis B virus (HBV) infection dark urine. Neuropathy, epileptiform seizures and simvastatin, lovastatin. Not recommended: in adults with compensated liver disease and Zidovudine, abacavir, halofantrine, lumefantrine, leucopenia on long term therapy. evidence of active viral replication, persistently
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Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIVIRAL DRUGS 8.6
elevated serum ALT and histological evidence of active inflammation and/or fibrosis. P Nucleoside naive patients: 0.5mg once daily, with or without food. Lamivudine-refractory: 1mg once daily, taken on an empty stomach. Duration: HBeAg+ patients, admin. at least until HBe seroconversion or until HBs seroconversion or loss of efficacy. In HBeAg- patients, admin. at least until HBs seroconversion or loss of efficacy. Review long-term treatment regularly. Renal impairment: Dose adjustment necessary if ccQ50ml/min, see SPC. Q Under 18 years, not recommended. D Pregnancy, lactation (unless clearly necessary, women of child-bearing potential should use effective contraception). HIV/HBV coinfected patients not receiving HAART. B Renal impairment. Monitor for exacerbations of hepatitis. Monitor decompensated cirrhosis patients, during and for r6 months after treatment. Risk of lactic acidosis, sometimes fatal, with hepatomegaly and hepatic steatosis reported; discontinue if signs/symptoms occur. Lamivudine-refractory: Monitor virological response and perform appropriate resistance testing; consider treatment modification in patients with suboptimal virological response after 24 weeks of treatment. Caution, liver transplant recipients. Co-infection with hepatitis C or D, HIV. Contains lactose. C Products that reduce renal function or compete for active tubular secretion. See SPC. A Insomnia, headache, dizziness, somnolence, vomiting, diarrhoea, nausea, dyspepsia, fatigue. Laboratory test abnormalities e.g. raised ALT, total bilirubin and amylase.
intervals for 7 days, omitting night time dose. Consider IV dosing in severely immunocompromised patients/those with impaired GI absorption. Start treatment as soon as possible. Renal impairment (ccQ10 ml/min), max 800mg twice daily at 12-hourly intervals; 10ml/ minQccQ25ml/min, 800mg 3 times a day at 6 to 8-hourly intervals. R Doses determined based on kidney function. Q Treatment and prophylaxis of herpes simplex infections in immunocompromised individuals: Over 2 years, as per adults. Under 2 years, half the adult dose. Varicella infections: 6 years and older, 800mg 4 times/day. 2-5 years, 400mg 4 times/day. Under 2 years, 200mg 4 times/ day. Continue for 5 days. Doses may be calculated as 20mg/kg body weight, 4 times daily. Max single dose: 800mg. B Caution: Elderly, patients with impaired cc. Not shown to reduce incidence of complications associated with chicken pox in immunocompromised patients. In severely immunocompromised patients, prolonged or repeated courses may result in selection of viral strains with reduced sensitivity. Pregnancy, lactation. C Drugs affecting renal function (e.g. probenecid). A Skin rash (resolves on withdrawal), GI symptoms. Reversible dizziness, confusion, hallucinations, somnolence (mainly in patients with impaired renal function or other complicating factors).
BELLVIRAX
2J
Ranbaxy
CELSENTRI
COMBIVIR
GSK
2JN NRTI. Lamivudine 150mg, zidovudine 300mg; white film-ctd cap.-shaped tab. marked GXFC3. 60, A461.59. S Antiretroviral combination therapy for the treatment of HIV infected adults. P 1 twice daily with or without food. Q Not recommended. D Severe renal or hepatic impairment. Low neutrophil (Q0.75 x 109/L) or Hb (Q7.5 g/dl or 4.65 mmol/L) levels. Pregnancy, lactation. B Mild to moderate renal or hepatic impairment. Monitor haematology and liver function prior to and regularly during therapy. C Drugs mainly eliminated via cationic transport eg trimethoprim. Ganciclovir, foscarnet. Phenytoin, aspirin, codeine, morphine, indomethacin, ketoprofen, naproxen, oxazepam, lorazepam, cimetidine, clofibrate, dapsone, isoprinosine. Systemic pentamidine, pyrimethamine, co-trimoxazole, amphotericin, flucytosine, interferon, vincristine,vinblastine, doxorubicin. Tribavirin, probenecid. A Anaemia, neutropenia, leucopenia, GI disturbance, anorexia, headache, rash, fever, myalgia, paraethesia, insomnia, malaise, asthenia. Convulsions, cerebral events. Hepatomegaly, hepatitis. Rarely pancreatitis.
COPEGUS
Roche
2NT Nucleoside analogue. Ribavirin 200mg, 400mg. Resp. light pink or reddish brown flat oval film-ctd
Pfizer tab. marked RIB 200 or 400 one side, ROCHE on
CCR5 antagonist. Maraviroc 150mg, 300mg. Blue, 2MO biconvex, oval film-ctd tabs marked Pfizer and Herpes-specific enzyme inhibitor. Aciclovir 200mg, MVC150 or MVC300 resp. 60, A966. 800mg. Cap.-shaped biconvex uncoated white to S In combination with other off-white tab. with strength embossed one side antiretrovirals in treatment-experienced adult and ACV the other. 200mg-25, A21.50; 800mg-35, patients infected with only CCR5-tropic HIV-1 A65.43. detectable. P 150mg, 300mg or 600mg twice daily S Treatment of herpes simplex virus infections involving skin and mucous membranes, depending on co-administrated antiretrovirals and other medicinal products (see SPC). incl. initial and recurrent genital herpes. Q Not recommended. Suppression of recurrence of herpes simplex D Peanut and soy allergies. Pregnancy infections in immunocompetent patients. (unless benefit outweighs risk), lactation. Prophylaxis against herpes simplex infections in B Use when only CCR5-tropic HIV-1 is immunocompromised individuals. Treatment of herpes zoster (shingles) and varicella (chicken pox) detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) as determined by tropism test on infections. newly drawn blood sample. Consider P Herpes simplex infections: 200mg 5 times/day at 4-hourly intervals, omitting night-time discontinuation in patients with symptoms of dose, for 5 days. Can be extended, depending on acute hepatitis, particularly with suspected drugrelated hypersensitivity or with increased liver severity. May be increased to 400mg in severely transaminases combined with rash or other immunocompromised patients or patients with systemic symptoms of hypersensitivity. Monitor malabsorption. Renal impairment, ccQ10ml/min, patients with pre-existing liver dysfunction. Renal max 200mg twice daily at 12-hourly interval. Suppression of recurrent herpes simplex infections impairment, dose adjustment only recommended in immunocompetent patients: 200mg, 4 times/day in patients receiving potent CYP3A4 inhibitors (see SPC). Caution: Hepatitis B/C co-infection, severe at 6-hourly intervals or 400mg twice daily at 12CVD, patients with history of postural hypotension hourly intervals. May be reduced to 200mg, 3 or on concomitant drugs known to lower BP. times daily at 8-hourly intervals or twice daily at Osteonecrosis, immune reconstitution syndrome 12-hourly intervals. 800mg/day or less may be associated with breakthrough viral infection. Stop may occur. treatment temporarily after 6-12 months to assess C Avoid St John’s wort, rifampicin with patient. Prophylaxis of herpes simplex infections in efavirenz. Caution: CYP3A4 inhibitors/ inducers (see SPC). immunocompromised individuals: 200mg, 4 times A Headaches, nausea, GI disorders, weight daily at 6-hourly intervals. May be increased to decrease, dizziness, paraesthesia, dysgeusia, 400mg in patients with severe immune system impairment or impaired GI absorption. Consider IV somnolence, cough, rash, pruritus, muscle spasms, back pain, asthenia, insomnia. Increased ALT, AST, dose as alternative. Herpes zoster and varicella gamma-glutamyl transferase. infections: 800mg, 5 times daily at 4-hourly
reverse. 42, A186.08; 112, A496.22; 168, A744.33, 400mg-56, A.485.06. S Treatment of chronic hepatitis C. Only for use as part of combined regimen with interferon a-2a or peginterferon a-2a. Monotherapy must not be used. P In combination with peginterferon soln. for inj- Genotype 1/4:Q75kg body weight 1000mg daily; q75kg body weight 1200mg daily. Genotype 2/3 800mg daily. In combination with interferon soln. for inj- Q75kg body weight 1000mg daily; q75kg body weight 1200mg daily.See SPC. Q Under 18 years, not recommended. D Pregnancy, lactation. Female patients: Initiate therapy only after -ve pregnancy test immediately prior to therapy initiation. History of severe pre-existing cardiac disease in previous 6 months, severe hepatic dysfunction or decompensated cirrhosis, Hbopathies (e.g. thalassaemia, sickle-cell anaemia). Initiation of peginterferon a-2a is contraindicated in HIV-HCV patients with cirrhosis and a Child-Pugh score q6. B Monotherapy not effective. A potential carcinogenic effect cannot be excluded. Monitor patients with pre-existing cardiac disease. Hypersensitivity reactions. Discontinue if hepatic decompensation develops. Monitor patients who develop psychiatric, CNS problems or depression. Evaluate renal function prior to therapy. Monitor Hb concentrations intensively during treatment. Periodic ophthalmologic exams during therapy for patients with pre-existing ophthalmologic disorders; discontinue if new or worsening ophthalmologic disorders develop. Patients coinfected with HIV and receiving HAART risk serious adverse effects. Monitor co-infected patients and assess Child-Pugh score during treatment; discontinue if q7. Patients with low
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
221
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS Q Up to 18 years, 6mg/kg up to max. 240mg (24ml) once daily. Under 4 months, not recommended. D Lactation. B Not recommended as monotherapy. Renal insufficiency (see SPC). Liver dysfunction, coinfection with HBV, other risk factors for liver disease and hepatic steatosis; monitor. Immune Reactivation Syndrome, lactic acidosis, mitochondrial dysfunction, lipodystrophy, osteonecrosis may occur. Pregnancy (use effective contraception). Elderly. C Drugs eliminated by active tubular secretion. Lamivudine, zalcitabine. A Headache, dizziness, asthenia, insomnia, abnormal dreams. GI disorders. Skin disorders, pain. Neutropenia, anaemia. Hypertriglyceridaemia, hyperglycaemia. Elevated serum AST/ALT, bilirubin, creatine kinase. Elevated Roche serum lipase, amylase incl. pancreatic amylase.
CD4 counts, caution. Haematology tests must be carried out prior to therapy. Uric acid increase may induce gout. Recommend regular dental exams and brushing teeth twice daily. Female patients must have routine pregnancy test during treatment and for 4 months thereafter. Female partners of male patients must have routine pregnancy test during treatment and for 7 months thereafter. C Didanosine (not recommended), stavudine (avoid), zidovudine (increased anaemia risk). A Anaemia, anorexia, depression, insomnia, headache, dizziness, impaired concentration, dyspnoea, cough, GI disorders, alopecia, dermatitis, pruritus, dry skin, myalgia, arthralgia, pyrexia, rigors, pain, asthenia, fatigue, inj. site reaction, irritability.
White film-ctd tab. marked FV and 250 on reverse and FAMVIR 750 resp. Shingles treatment pack 250mg-21, A130.40; 750mg-7, A53.20. S Herpes zoster. P 750mg once daily or 250mg three times daily for 7 days. Q Not recommended. B Renal impairment.
FUZEON
Roche
2JN
Fusion inhibitor. Enfuvirtide 90mg/ml. Powder in vial for soln. 60, A1835.29. S In combination with other antiretrovirals for treatment of HIV-1 patients who failed on regimens containing at least one antiretroviral (among PI, NNRTI or nRTI) or are intolerant to previous antiretroviral regimens. R q65 years, not recommended. CYMEVENE V Under 16 years, see SPC; over 16 years, 2JN 90mg twice daily by SC inj. into upper arm, EPIVIR GSK anterior thigh or abdomen. Nucleoside analogue. Ganciclovir 500mg. Powder 2JN B Does not reduce risk of HIV transmission in vial. 5, A234.34. to others. Increased rate of some bacterial S Treatment of life-threatening or sightNRTI. Lamivudine 150mg, 300mg. Film-ctd threatening cytomegalovirus (CMV) infections in diamond-shaped tabs. 150mg, white marked GX infections, pneumonia, hypersensitivity reactions, immunocompromised individuals. These states CJ7. 300mg, grey marked GX EJ7. 150mg-60, liver disease, chronic hepatitis B and C. Admin. to A207.83; 300mg-30, A207.83. might include acquired immunodeficiency non-HIV-1 infected patients may result in false syndrome (AIDS), iatrogenic immunosuppression 2JN positive HIV test with HIC ELISA test. Severe renal associated with organ transplantation, or impairment and patients on dialysis, reduced ALSO EPIVIR ORAL SOLUTION Lamivudine 10mg/ chemotherapy for neoplasia. Prevention of CMV hepatic function. Immune reactivation syndrome. ml. 240ml, A55.45. infection in patients on immunosuppressive Pregnancy, Lactation. Osteonecrosis. S Part of antiretroviral combination therapy following organ transplantation. A Inj. site reactions, sinusitis, skin therapy for HIV infected adults and children. P Treatment: initially 5mg/kg IV over 1 P 150mg twice daily or 300mg once daily. papilloma, flu, ear infection, lymphadenopathy, hour every 12 hours for 14-21 days. Long term IV Q Under 3 months, not recommended; 3 decreased appetite and weight, anorexia, anxiety, 6mg/kg daily for 5 days or 5mg/kg daily for 7 months-12 years 4mg/kg body weight daily. Max. nightmare, irritability, peripheral neuropathy, days. Prevention: initially 5mg/kg IV 12 hourly for 300mg daily. conjuctivitis, pneumonia, GI disorders, pancreatitis, 7-14 days, 6mg/kg daily for 5 days or 5mg/kg daily D Lactation. pruritus and other skin disorders, myalgia, for 7 days. For doses in renal impairment see B Renal impairment, hepatitis, co-infection asthenia, hypertriglyceridaemia, diabetes, SmPC. with hepatitis C. Discontinue if symptomatic attention disturbance, tremor, vertigo, nasal D Hypersensitivity to acyclovir. Pregnancy, hyperlactatemia and metabolic acidosis, congestion, calculus renal, haematuria. lactation. progressive hepatomegaly, or elevating B Contraceptive measures should be taken aminotransferase levels occur. Monitor liver HEPSERA Gilead by women of child-bearing age during therapy function tests. 2NT and males advised to practice barrier C Other lamivudine or emtricitabine Acyclic nucleotide phosphonate analogue. contraception during and for at least 90 days containing drugs, co-trimoxazole (avoid). Caution: Adefovir dipivoxil 10mg (equiv. adefovir 5.45mg). Trimethoprim, sulfamethoxazole. following therapy. Renal impairment ensure White, round, bevelled-edge tab. marked GILEAD A Headache, insomnia, cough, nasal adequate hydration during IV admin. Limited 10 one side and liver shape on reverse. 30, symptoms, nausea, GI disorders, rash, alopecia, experience in children, potential for long-term A549.06. arthralgia, muscle disorders, fatigue, malaise, carcinogenicity and reproductive toxicity. S Chronic hepatitis B in adults with: fever. C See SPC (a)Compensated liver disease with evidence of A GI upset, mouth ulceration, anorexia, FAMCICLOVIR TEVA Teva active viral replication, persistently elevated serum dyspnoea, pruritus, rash, fever, headache, ALT levels and histological evidence of active liver infections, malaise, photosensitivity reaction, 2NO inflammation and fibrosis. (b)Decompensated liver arrhythmias, hypertension, hypotension, anxiety, Nucleoside analogue. Famciclovir 125mg, 250mg. disease. ataxia, confusion, depression, abnormal liver White to off-white, round, film-ctd tabs marked P 1 once daily. Monitor every 6 months function tests, pancreatitis. 93 on one side and 8117 or 8118 resp. on reverse. for hepatitis B biochemical, virological and 125mg-10, A19.01; 250mg-15, A 57.01. serological markers. EMTRIVA Gilead S Herpes zoster of the skin and mucous Q Under 18 years, not recommended. membranes in immunocompetent patients with 2MT D Lactation. NRTI. Emtricitabine 200mg. Hard opaque cap. with severe course of infection anticipated, including B Monitor normal renal function every 3 herpes zoster ophthalmicus. Herpes zoster and white body and light blue cap, printed with months. Dose adjustment necessary if ccQ50ml/ herpes simplex in immunocompromised patients. 200mg on cap and GILEAD and Gilead logo on min. Cirrhosis. Co-infection with hepatitis C or D, P 500mg three times daily. Herpes zoster: HIV. Risk of lactic acidosis, sometimes fatal in body. 30, A276.59. S HIV-1 infection in adults and children in Initiate asap (within 48 hours) of onset of rash; patients (particularly obese women) with duration 7 days in immunocompetent and 10 days hepatomegaly, hepatitis, or other known risk combination with other antiretroviral agents. in immunocompromised patients. Herpes simplex: factors of liver disease. Elderly. Women of childP 1 daily. Renal insufficiency (cc Q50ml/ Initiate asap after onset of lesions; duration 7 min): Dose interval adjustment required. bearing potential, use effective contraception. days. R As for adults. Pregnancy (if benefit outweighs risk). Monitor for Q Not recommended. Q Over 4 months and over 33kg, as for exacerbations of hepatitis after discontinuation of B Renal impairment (see SPC). adults. Under 4 months, not recommended. treatment. 2MT C Products excreted renally, or which FAMVIR Novartis ALSO EMTRIVA ORAL SOLUTION Emtricitabine affect renal function (incl. hOAT1). See SPC 2NO 10mg/ml. 170ml, A76.88. A GI disturbances, asthenia, abdominal Nucleoside analogue. Famciclovir 250mg, 750mg. P 240mg (24ml) once daily. pain, headache. Renal disturbances.
222
2
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c
s
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES IMMUKIN
ANTIVIRAL DRUGS 8.6 Boehringer Ing.
2NT Recombinant human interferon. Interferon gamma-1b 0.1mg. Soln. for inj. in vial. 6, A657.72. S Reduction of frequency of serious infections in patients with: Chronic granulomatous disease (CGD), severe, malignant osteopetrosis. P 50mcg/m2 (body surface area q0.5m2) and 1.5mcg/kg/dose (body surface are R0.5m2). Inj. given SC, preferably in evening, 3 times weekly. Q Under 6 months, not recommended for CGD. D Hypersensitivity to closely related interferons. B Cardiac disease, history of seizures and/ or compromised CNS function, severe renal insufficiency. Monitor haematology. Pregnancy, lactation. C Co-admin. with other serum protein/ immunological products. A Headache, nausea/vomiting, rash, myalgia, fever, inj. site reactions.
Pregnancy (use only if benefit justifies risk). C Not recommended: Efavirenz, nevirapine, nelfinavir, indinavir, tipranavir/ ritonavir, anticonvulsants, rifampicin, rifapentine, diazepam, St John’s Wort. Caution: Antiarrhythmics, warfarin, rifabutin, systemic immunosuppressants, systemic dexamethasone, clarithromycin, other substrates of CYP3A4, CYP2C9 and CYP2C19. A Thrombocytopenia, anaemia, peripheral neuropathy, headache, GI disorders, renal failure, rash, diabetes, hyperglycaemia, hypercholesterolaemia, hypertriglyceridaemia, hyperlipidaemia, dyslipidaemia, hypertension, fatigue, anxiety, insomnia.
INVIRASE
Roche
2JN
Protease inhibitor. Saquinavir 500mg. Light orange to greyish or brownish orange biconvex film-ctd tab. marked ROCHE and SQV 500. 500mg-120, A409.58. S HIV-1 infections in adults, in combination with ritonavir and other antiretroviral drugs. P 1000mg twice daily (taken with 100mg ritonavir) in combination with other antiretroviral agents, within 2 hrs of a meal. R Over 60 years, limited experience. Q Under 16 years, limited experience. D Severe hepatic impairment. Lactation. INTRONA Schering-Plough B Severe renal/moderate hepatic impairment, chronic diarrhoea or malabsorption, 2NT haemophiliac patients, diabetes mellitus, Single-subtype recombinant interferon. Interferon hyperglycaemia, hepatitis B/C, cirrhosis; caution. alpha-2b (rbe) 10 MIU. Powder in vial plus WFI. 1 Lipodystrophy, Immune Reactivation Syndrome. syringe, 2 needles, 1 cleansing swab. 1, A77.48. Pregnancy (only if essential). Contain lactose. 2NT C Contra: Terfenadine, astemizole, ALSO INTRONA MULTIDOSE VIALS Interferon alfa- pimozide, cisapride, amiodarone, propafenone, 2b (rbe) 10 MIU/ml (2.5ml). Plus syringe kits flecainide, midazolam, triazolam, simvastatin, IMUNOVIR Newport Pharmaceuticals containing syringe, needles, sterets and plasters. lovastatin, ergot alkaloids, rifampicin, garlic caps. 10 MIU/ml-1 x 2.5ml, A190.23. Caution: Some other PIs, atorvastatin, oral 2NO 2NT contraceptives, substrates/ inhibitors/ inducers of Immunomodulator. Inosine pranobex 500mg. ALSO INTRONA MULTIDOSE INJECTION PENS 18 CYP3A4 and/or P-gp, See SPC White ovoid tab. 100, A42.68. A139.47; 30 MIU (25 MIU/ml), MIU (15 MIU/ml), A GI disorders, headache, peripheral S Management of patients with A232.44; 60 MIU (50 MIU/ml), A464.88. neuropathy, numbness extremities, paraesthesia, immunodepression suffering from viral infections S Chronic hepatitis B and C, hairy cell and dizziness, rash, pruritus, asthenia, fatigue, fever, incl. subacute sclerosing panencephalitis (SSPE), pain. varicella and herpes simplex (type I and II). Genital chronic myeloid leukaemia, multiple myeloma, warts, as adjunctive therapy to podophyllin or CO2 follicular lymphoma, carcinoid tumours, malignant ISENTRESS MSD melanoma. laser. V See SPC. P 50mg/kg of body weight up to a 2N D History of severe pre-existing cardiac maximum of 4g (usually 2 tabs 3-4 times a day). Integrase strand transfer inhibitor. Raltegravir (as SSPE: 100mg/kg of body weight up to a maximum disease. Severe renal/hepatic dysfunction. Epilepsy, K+) 400mg. Pink, oval film-ctd tab. marked 227. 60, compromised CNS. Chronic hepatitis with of 3-4g continuously with regular monitoring. 3g A810.00. decompensated cirrhosis or in patients being or daily in divided doses for 28 days. S In combination with other antiQ Under 1 year, not recommended; over 1 have been treated recently with retrovirals for HIV-1 infection in adults. immunosuppressives excluding short term year, 50-100mg/kg body weight daily in four P 400mg administered twice daily. corticosteroid withdrawal. Autoimmune hepatitis; Q Under 16 years, not recommended. divided doses; over 12 years, as for adults. or history of autoimmune disease; D Patients presently suffering from gout D Pregnancy, lactation. immunosuppressed transplant recipients. or elevated uric acid blood levels. B Caution: Severe hepatic impairment, Uncontrolled pre-existing thyroid disease. Severe B May be administered with caution in chronic hepatitis B or C (monitor), elderly. ARTpsychiatric conditions (or history of) in children. patients with a history of gout, hyperuricaemia, naive patients. Reported: Osteonecrosis (monitor hepatic dysfunction, urolithiasis or in patients with Pregnancy, lactation. for signs of joint aches), immune reactivation B Caution: History of pulmonary disease, impaired renal function. syndrome (monitor for inflammatory symptoms), diabetes prone to ketoacidosis, coagulation C Xanthine oxidase inhibitors, myopathy and rhabdomyolysis. Contains lactose. disorders, severe myelosuppression, psoriasis/ corticosteroids, uricosuric agents. C Caution: Strong uridine diphosphate sarcoidosis, patients predisposed to autoimmune A Elevated levels of uric acid. glucuronosyltransferase (UGT) 1A1 inducers, eg disorders, adults with severe psychiatric conditions. rifampicin (if unavoidable, double Isentress dose); INTELENCE Janssen-Cilag Monitor for psychiatric disorders. Monitor if liver strong enzyme inducers, eg. phenytoin, function abnormalities develop. Hypotension may phenobarbital, no data. Avoid drugs increasing 2JM occur. Ensure adequate hydration. Monitor: NNRTI. Etravirine 100mg. White to off-white oval gastric pH (eg. PPIs, H2 antagonists). tab. debossed with T125 one side and 100 on the History of CHF, MI, arrhythmic disorders. Driving A Dizziness, vertigo, GI disorders, fatigue, or using machinery. See SPC. other. 120, A547.06. asthenia. Stevens Johnson syndrome, rash, C Ribavirin, see SPC. Caution: Narcotics, S Treatment of HIV-1 infection in headache, insomnia, abnormal dreams, increased antiretroviral treatment-experienced adult patients hypnotics, sedatives, other potentially AST/ALT/triglycerides. myelosuppressive agents, xanthine derivatives, in combination with a boosted protease inhibitor shosaikoto (Chinese herbal medicine), other and other antiretroviral medicinal products. ISOPRINOSINE Newport Pharmaceuticals chemotherapeutics. P 200mg twice daily following a meal. 2NO A Infections, anorexia, hyperuricemia, Only in combination with other antiretrovirals. Immunomodulator. Inosine pranobex 500mg white hypocalcemia, thirst, dehydration, psychiatric Q Not recommended. scored tab. 24, A10.28. disorders, nervous system disorders, cough, D Lactation. 2NO dyspnoea, epistaxis, respiratory disorder, GI B Decreased virologic response for some ALSO ISOPRINOSINE SYRUP Inosine pranobex disorders, Hyper/hypo thyroidism, arthralgia, viral strains, see SPC. Not recommended: Severe 250mg/5ml. Syrup. 120ml, A6.26. musculoskeletal pain, arthritis, inj site reaction, hepatic impairment. Discontinue if severe fatigue, flu-like symptoms, irritability, skin and SC S Management of patients with cutaneous reactions, Stevens-Johnson Syndrome, tissue disorders, eye disorder, micturition immunodepression suffering from viral infections severe hypersensitivity syndrome or erythema frequency, reproductive/breast disorders, chest incl. subacutesclerosing panencephalitis, varicella. multiforme occur. May also occur: Lipodystrophy, pain, hepatomegaly, blood/lymphatic disorders, Herpes simplex (type I and II) and management of immune reconstitution syndrome, osteonecrosis. tinnitus, vertigo, palpitation, tachycardia, recurring Herpes simplex (type I and II). The Caution: Elderly, moderate hepatic impairment, HBV or HCV co-infection. Contains lactose. hypertension, weight decrease. See SPC. treatment of Genital Warts. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
223
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
Q Under 18 years, not recommended. D Autoimmune hepatitis; severe hepatic dysfunction or decompensated cirrhosis; preexisting cardiac disease or psychiatric conditions. Pregnancy, lactation. B Perform haematological and biochemical tests prior to therapy and periodically. Evaluate TSH and T4 levels prior and during therapy. Severe psychiatric adv. events may manifest eg. depression, suicidal attempts. Monitor ECG with pre-existing cardiac abnormalities. Increase in ALT levels despite dose reduction; discontinue. Patients co-infected with HIV and receiving HAART; caution. Effective contraceptive measures required. Anaemia, psoriasis, sarcoidosis, diabetes, impaired pulmonary function, autoimmune disorders may ccur. C Caution: Theophylline, myelosuppressive agents. A Fatigue, pyrexia, rigors, inj.-site KIVEXA GSK reactions, asthenia, pain, GI disorders, anorexia, weight loss, myalgia, arthralgia, headache, 2JN NRTIs. Abacavir (as sulfate) 600mg and lamivudine insomnia, irritability, depression, dizziness, 300mg. Orange, film-ctd, cap.-shaped tab. marked concentration impairment, anxiety, dyspnoea, cough, alopecia, pruritus, dermatitis, dry skin, fluGS FC2. 30, A591.95. like syndrome, ocular changes. S Antiretroviral combination therapy for the treatment of HIV infection. Not for use in PREZISTA Janssen-Cilag patients carrying the HLA-B*5701 allele, unless no 2JM other therapeutic option available. Protease inhibitor. Darunavir (as ethanolate) P 1 once daily. 75mg, 150mg, 400mg, 600mg. Resp., white capletQ Under 12 years or under 40kg, not shaped, white oval-shaped, light orange ovalrecommended. shaped or orange oval-shaped tab, debossed with D Severe hepatic impairment. Pregnancy, strength on one side and TMC on the other side. lactation. 75mg-480, A776.47; 150mg-240, A776.47. 400mgB cc Q50ml/min; not recommended. Moderate hepatic impairment, not recommended 60, A625.21; 600mg-60, A776.47. S HIV-1 infection. In antiretroviral therapy unless judged necessary. Monitor for (ART) naive adults, co-administered with low dose hypersensitivity reaction symptoms; discontinue ritonavir in combination with other antiretrovirals. immediately if occurs. Risk of lactic acidosis. Caution with hepatomegaly, hepatitis or other risk In treatment-experienced adults and children q 6 years and q20kg, incl. those that have been factors for liver disease and hepatic steatosis. highly pre-treated, co-administered with low dose Lipodystrophy, Immune Reactivation Syndrome, opportunistic infections may occur. Child exposed ritonavir in combination with other antiretrovirals. P To be taken with food. ART-naive in utero; monitor for signs of mitochondrial patients: 800mg with 100mg ritonavir once daily. dysfunction. Contain azo colouring agent sunset ART-experienced patients: 600mg taken with yellow. 100mg ritonavir twice daily. C Ganciclovir, foscarnet, zalcitabine (not Q ART-naive: Not recommended. ART recommended). Caution: Methadone, rifampicin, experienced: r20 kg-Q30 kg: 375mg with 50mg phenobarbital, phenytoin, drugs eliminated via ritonavir twice daily. r30kg-Q40kg: 450mg with active renal secretion (e.g. trimethoprim), co60mg ritonavir twice daily. r40kg: 600mg with trimoxazole, tenofovir. 100mg ritonavir twice daily. A Potentially life-threatening D Severe hepatic impairment. Lactation. hypersensitivity reaction, anorexia, headache, B Caution: Elderly, known sulphonamide insomnia, GI disorders, rash, alopecia, arthralgia, allergy, mild/moderate hepatic impairment, muscle disorders, fever, fatigue. chronic hepatitis B or C, haemophiliac patients PEGASYS Roche (increased bleeding risk). May occur: Severe skin rash (may be accompanied by fever and/or 2NT transaminases elevations), erythema multiforme Antiviral/immunomodulator. Peginterferon alfa-2a and Stevens Johnson syndrome, new onset 135mcg, 180mcg. 0.5ml soln. in pre-filled syringe. diabetes mellitus, hyperglycaemia, or exacerbation 135mcg-1, A220.29. 180mcg-4, A1021.00. of existing diabetes mellitus, lipodystrophy, S HBeAg-positive or HBeAg-negative osteonecrosis, immune reactivation syndrome. chronic hepatitis B. Chronic hepatitis C, incl. Pregnancy (use only if benefit outweighs risk). patients with compensated cirrhosis, with optimal Driving or using machines if dizziness occurs. use in combination with ribavirin; monotherapy C Contra: Rifampicin, lopinavir/ritonavir indicated mainly in case of intolerance or combination, herbal preparations containing St Johnâ&#x20AC;&#x2122;s wort, antiarrhythmics (amiodarone, bepridil, contraindication to ribavirin. quinidine, systemic lidocaine), antihistamines P 180mcg once weekly by SC inj. in abdomen or thigh. Hepatitis B: Duration 48 weeks. (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, Hepatitis C: Duration of combination therapy depends on viral genotype. Genotype-1, 48 weeks; methylergonovine), GI motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ genotype 2/3, 24 weeks. Duration for monotherapy, 48 weeks. End stage renal disease: hypnotics (triazolam, midazolam administered Initially 135mcg. orally and HMG-CoA reductase inhibitors P 50mg/kg daily up to max. of 4 g daily in 3-4 divided doses. The normal duration of treatment is 5-14 days. SSPE dosage 100mg/kg of body weight up to a maximum of 3-4g continuously with regular monitoring. Genital Warts dosage 3g (20ml x 3 times a day) for a total of 14-28 days Q Under 1 year, not recommended; over 1 year, 50mg/kg body weight daily in four divided doses ( 1 tab./10kg up to 20kg); over 12 years, as for adults. D Patients presently suffering from gout or elevated uric acid blood levels. B Renal impairment, gout or hyperuricaemia, hepatic dysfunction. Pregnancy, lactation. C Xanthine oxidase inhibitors, uricosuric agents. A Elevated levels of uric acid.
224
(simvastatin and lovastatin). Caution: Drugs metabolised by CYP2C9, CYP2C19, CYP2C8, CYP2D6 and CYP3A4 (see SPC). A Lipodystrophy, hypertriglyceridaemia, hypercholesterolaemia, hyperlipidaemia, insomnia, headache, peripheral neuropathy, dizziness, GI disorders, increased ALT and AST, rash (including macular, maculopapular, papular, erythematous and pruritic rash), pruritus, asthenia, fatigue.
REBETOL
Schering-Plough
2NT Nucleoside analogue. Ribavirin 200mg. Opaque white hard cap. marked with blue ink. 84, A466.69; 140, A777.83; 168, A933.40.
2NT ALSO REBETOL ORAL SOLUTION Ribavirin 40mg/ ml. Clear, colourless to pale or light yellow oral soln. S Chronic hepatitis C in combination with peginterferon a-2b (adults previously untreated or who failed previous a-interferon therapy (caps only)) or interferon a-2b (previously untreated adults and children). Do not use monotherapy. P Q65kg, 800mg daily divided into 2 in the morning and 2 in the evening; 65-85kg, 1000mg daily divided 2 morning and 3 evening; 86-105kg 1200mg daily divided 3 morning and 3 evening. q105kg 1400mg daily divided 3 morning and 4 evening. Duration depends on drug used in combination and patient genotype (see SPC). Dosage modification guidelines (see SPC). Q Adolescents, children over 3 years: Ribavirin 15mg/kg/day + interferon a-2b 3 MIU/m2 3 times a week. Genotype 1: 1 year; genotype 2, 3: 24 weeks. D Cardiac disease, haemoglobinopathies (eg. thalassemia, sickle-cell anaemia), chronic renal failure, ccQ50ml/min, haemodialysis, severe psychiatric conditions, severe hepatic dysfunction, liver cirrhosis, autoimmune disease, thyroid disease. Lactation. Pregnancy: Negative pregnancy test then effective contraceptive up to 4 months after treatment for female patients, and up to 7 months after treatment for male patients and female partners. Men whose partners are pregnant must use a condom to minimise delivery of ribavirin to partner. Perform routine monthly pregnancy tests. B Assess cardiac status at start. Monitor liver function, haematological values and blood chemistry before, at 2 and 4 weeks, and periodically thereafter. CHF, MI, arrhythmias; perform ECG prior and during therapy. Renal impairment; monitor for anaemia. HIV-positive subjects. Withdraw if acute hypersensitivity reactions develop. Potential risk of dose reduction. Gout. Dental disorder. Monitor for CNS effects, particularly depression and suicidal ideation. Growth; monitor thyroid every 3 months (children, adolescents). Contains lactose. C Antacids, nucleoside analogues (caution). Didanosine not recommended. A Viral infection, pharyngitis, rhinitis, anaemia, haemolysis, neutropenia, hypothyroidism, anorexia, weight decrease, depression, insomnia, anxiety, dry mouth, headache, dizziness, cough, dyspnoea, myalgia, arthralgia, musculoskeletal pain, flu-like symptoms, asthenia, inj. site reaction.
RETROVIR
GSK
2JN Nucleoside analogue. Zidovudine 100mg. White
2
5
m
c
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIVIRAL DRUGS 8.6
for at least 6 months after treatment. Monitor for lactic acidosis (usually associated with severe hepatomegaly with steatosis). Myalgia and 2JN myopathy may occur (discontinue). Carefully ALSO RETROVIR TABLETS Zidovudine 300mg. weigh potential benefit and risks of concomitant White scored film-ctd tab. marked WELLCOME treatment with products associated with myopathy X4F. 60, A252.27. (e.g. statins, fibrates, ciclosporin). Peripheral 2JN neuropathy may occur (particularly with ALSO RETROVIR SYRUP Zidovudine 50mg/5ml. concomitant pegylated interferon alfa-2a); Sugar-free soln. 200ml, A33.47. reconsider treatment options if symptoms develop. S Use in combination with other Cirrhosis: With decompensation, not indicated; antiretrovir agents (except in pregnancy) for without decompensation, caution. Clinical efficacy treatment of HIV infection. Monotherapy in HIVnot established for antiviral resistant HBV. positive pregnant patients (over 14 weeks Pregnancy (only if benefits outweigh risk). gestation) and their newborn infants. C Caution: Substances affecting renal P In combination, 500-600mg daily in 2-3 function, subcutaneous pegylated interferon alfadivided doses. Pregnant women, see SPC. 2a. Not recommended for use with lamivudine. Q Under 3 months, see lit. 3 months-12 A Dizziness, headache, cough, diarrhoea, years, 360-480mg/m2 daily in 3-4 divided doses in ROFERON-A Roche nausea, abdominal pain, rash, fatigue. Increased combination with other agents. amylase, lipase, alanine aminotransferase, creatine 2 N T 2JN phosphokinase. See SPC. ALSO RETROVIR IV Zidovudine 200mg/20ml. Soln. Single-subtype recombinant. Interferon alfa-2a (rbe) 3, 4.5, 6, and 9 mega units. Pre-filled for inf. Vial-5 x 20ml, A81.42. SUSTIVA BMS syringes, cartridge for Roferon-Pen. 3 mega units-1 S Use only when oral treatment is not x 0.5ml, A22.83; 4.5 mega units-1 x 0.5ml, A34.23; 2 N possible. Non-NRTI (NNRTI). Efavirenz 50mg, 100mg, 200mg, 6 mega units-1 x 0.5ml, A45.65; 9 mega units-1 x P Dilute prior to admin. 1-2mg/kg body 600mg. Dark yellow/whitecap., white cap., dark 0.5ml, A68.48. weight every 4 hours. See SPC. yellow cap. and dark yellow tab. resp. All caps. S AIDS-related Kaposi’s sarcoma. Chronic Q 80-160mg/m2 every 6 hours. See lit. active hepatitis B (patients positive for HBV-DNA), marked with SUSTIVA and strength. 600mg, cap.D Low neutrophil cell counts (Q 0.75 x 9 shaped, film-ctd tab. marked with SUSTIVA on 10 /L) or low Hb levels (Q7.5g/decilitre). Newborn chronic hepatitis C (patients positive to HCV both sides. 50mg-30, A29.47; 100mg-30, A58.94; infants with hyperbilirubinaemia. Lactation. antibodies with elevated ALT levels), malignant B Perform blood tests at least every 2 melanoma, chronic myeloid leukaemia, cutaneous 200mg-90, A352.96; 600mg-30, A335.19. S In combination with other antiretroviral weeks for the first 3 months of therapy and at T-cell lymphoma, hairy cell leukaemia. agents for the treatment of HIV-1 infected least monthly thereafter. Adjust dose if anaemia P Hepatitis B: 2.5-5 mega units/m2 by SC patients. or myelosuppression occurs or is present. Renal or inj. 3 times per week for 4-6 months. Increase P In combination with NRTI with or hepatic impairment. Elderly. Pregnancy. dose after 1 month if response not adequate, without a PI, 600mg once daily on empty stomach. C Chronic admin. of analgesics, discontinue after 3-4 months if no improvement. Q Under 3 years or under 13 kg, not particularly paracetamol. Drugs affecting hepatic Hepatitis C: initially 6 mega units by SC or deep recommended; 13-15kg, 200mg once daily; 15glucuronidation or inhibiting hepatic microsomal IM inj. 3 times per week for 3 months. 20kg, 250mg once daily; 20-25kg, 300mg once enzymes. Other potentially nephrotoxic or Maintenance: 3 mega units 3 times per week for daily; 25-32.5kg, 350mg once daily; 32.5-40kg, myelosuppressive drugs. Probenecid, valproic acid, further 3 months. For remaining indications See 400mg once daily; over 40kg or over 17 years, as fluconazole, methadone, ribavirin, stavudine. SPC. per adults. Caution patients about concomitant use of selfQ Not recommended. 2N administered drugs. D Severe renal, hepatic or myeloid ALSO SUSTIVA ORAL SOLUTION Efavirenz 30mg/ A Anaemia, neutropenia, leucopenia. dysfunction, epilepsy or CNS impairment, cardiac ml. 180ml, A98.15. Nausea, headache, rash, abdominal pain, fever, disease, decompensated hepatic disease, liver P 24ml once daily, in patients unable to paraesthesia, anorexia, myalgia, insomnia. cirrhosis. Lactation. swallow tabs or caps. B Should only be used by physicians V 3-17 years, see SPC. REYATAZ BMS experienced in the indications. Patients with D Severe hepatic impairment. Pregnancy suicidal tendencies. Severe myelosuppression 2JN (adequate contraception for 12 weeks after Protease inhibitor. Atazanavir (as sulphate) 150mg, (monitor blood counts). Moderate renal or hepatic discontinuation), lactation. impairment (monitor function). Pregnancy (ensure 200mg, 300mg. Hard, opaque blue (150, 200mg) B Mild to moderate hepatic impairment, effective contraception). or red and blue (300mg) caps. printed with BMS hepatitis B or C; monitor liver enzymes, consider C Immunosuppressants, theophylline. 150, 200 or 300 on one half and 3624, 3631 or withdrawal if transaminase 5 x normal. Severe A Influenza-like symptoms, GI and CNS 3622 resp. on other half. 150mg-60, A575.15; renal failure; monitor patient closely. History of effects, alterations of hepatic function. 200mg-60, A602.81; 300mg-30, price on request. seizures. Inflammatory reaction (immune S Treatment of HIV-1 infected adults, in SEBIVO Novartis reactivation syndrome) may arise. Cases of combination with other antiretrovirals. osteonecrosis have been reported. Driving/ 2MT P 300mg once daily taken with ritonavir operating machines. Nucleoside analogue. Telbivudine 600mg. White to C Terfenadine, astemizole, cisapride, 100mg once daily and with food. slightly yellowish, oval film-ctd tab, with LDT on Q Children and adolescents, not midazolam, triazolam, pimozide, bepridil, ergot one side. 28, A427.08. recommended. alkaloids, voriconazole, St John’s wort (all S Treatment of chronic hepatitis B in D Moderate to severe hepatic contraindicated), saquinavir, itraconazole. Caution: adults with compensated liver disease and insufficiency. Lactation. Other substrates of CYP3A4, indinavir, lopinavir/ evidence of viral replication, persistently elevated B Mild hepatic insufficiency, chronic ritonavir, ritonavir, grapefruit juice, rifabutin, oral serum ALT and histological evidence of active hepatitis, liver dysfunction; discontinue if contraceptives (also use reliable barrier inflammation and/or fibrosis. condition worsens. Conduction problems (2nd contraceptive), anticonvulsants, methadone, P 600mg once daily. Renal impairment: degree or higher atrioventricular or complex statins. Not recommended with fixed combination Dose adjustment necessary if ccQ50ml/min, see bundle-branch block), haemophiliac patients, tab. SPC. nephrolithiasis, diabetes, bradycardia, long containing efavirenz, emtricitabine, tenofovir R Above 65 years, no data. congenital QT, electrolyte imbalances. disoproxil fumarate (Atripla). Q Under 16 years, not recommended. Inflammatory reaction (immune reactivation A Skin rash; discontinue if severe. CNS D Lactation. syndrome) may arise. Contains lactose. Risk of reactions (dizziness, insomnia, impaired B Severe acute exacerbations of chronic hyperbilirubinemia. Osteonecrosis has been concentration, abnormal dreams, somnolence), anxiety, depression, GI upset, headache, fatigue, hepatitis B may occur; monitor hepatic function reported. Not recommended in patients cap. marked 100 and Y9C, with company logo and blue securiband. 100mg-100, A140.15.
undergoing haemodialysis. Pregnancy (no data). C Contra: Rifampicin, quinidine, midazolam, St. John’s Wort or substrates of CYP3A4 with narrow therapeutic windows. Not recommended: Fluticasone or other glucocorticoids, PPIs, nevirapine, efavirenz, bepridil, simvastatin, lovastatin, indinavir, other protease inhibitors. Avoid: Oral contraceptives. Caution: Irinotecan, diltiazem, verapamil, antiarrhythmics, atorvastatin, H2-receptor antagonists, immunosuppressants, clarithromycin, rifabutin, ketoconazole and itraconazole, warfarin, products inducing PR prolongations/QT intervals, buprenorphine, sildenafil, didanosine. A Jaundice, lipodystrophy syndrome, rash, headache, ocular icterus, GI disorders, fatigue, QTc prolongation, torsades de pointes.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
225
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
raised liver enzymes, lipodystrophy.
SYNAGIS 2NT
Monoclonal antibody. Palivizumab 50mg, 100mg. Powder and solvent for soln for inj. Prices available on request. S Prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV (see SPC). Q Under 2: 15mg/kg of body weight by IM inj. Admin. 1st dose prior to RSV season (where possible); admin. subsequent doses monthly throughout RSV season. Cardiac bypass: Admin. as soon as stable after surgery and monthly thereafter through remainder of RSV season. D Hypersensitivity to other humanised monoclonal antibodies. B Allergic reactions. Moderate to severe acute infection or febrile illness. Caution: Thrombocytopaenia or any coagulation disorder. A Nervousness, fever, inj. site reaction.
TAMIFLU
Roche
2NO Neuraminidase inhibitor. Oseltamivir (as phos.) 30mg, 45mg, 75mg. Hard caps. Resp. light yellow opaque body/light yellow opaque cap; grey opaque body/grey opaque cap; grey opaque body/ light yellow opaque cap. All marked ROCHE on body and strength on cap. 30mg, 45mg, prices on request. 75mg-10, A20.88.
2NO ALSO TAMIFLU SUSPENSION Oseltamivir (phos.) 12mg/ml. Powder for oral suspension. 10 doses of 75mg, A20.88. S Treatment of influenza virus in presence of symptoms typical of influenza, when influenza virus is circulating in the community. Post exposure prevention. Not a substitute for influenza vaccination. P Treatment: Initiate within 2 days of first onset of symptoms. 75mg twice daily for 5 days. Post exposure prevention: Initiate within 2 days of exposure. 75mg once daily for 10 days. Severe renal impairment, see SPC. Susp: An oral dispenser with 30mg, 45mg and 60mg graduations is provided for dosing. Q Treatment: Initiate within 2 days of first onset of symptoms. Duration: 5 days. 13-17 years: 75mg twice daily. 1-12 years: R15kg, 30mg twice daily; q15kg-23kg, 45mg twice daily; q23kg-40kg, 60mg twice daily; q40kg, 75mg twice daily. Under 1 year (in case of H1N1 pandemic): 2-3mg/kg twice daily under medical supervision. Post exposure prevention: Initiate within 2 days of exposure. Duration: 10 days. 13-17 years: 75mg once daily. 112 years: R15kg, 30mg once daily; q15kg-23kg, 45mg once daily; q23kg-40kg, 60mg once daily; q40kg, 75mg once daily. Under 1 year (in case of H1N1 pandemic): 2-3mg/kg once daily under medical supervision. B Safety and efficacy not established: Severe or unstable medical condition at imminent risk of requiring hospitalisation, immunocompromised, chronic cardiac disease and/ or respiratory disease. Severe renal impairment. Pregnancy, lactation. C Chlorpropamide, methotrexate, phenylbutazone. A Vomiting, nausea, headache.
TRUVADA
Gilead
2JN
NRTIs. Emtricitabine 200mg and tenofovir disoproxil 245mg (equiv. tenofovir disoproxil fumarate 300mg or tenofovir 136mg). Blue, cap.shaped, film-ctd tab. marked GILEAD on one side GSK and 701 on reverse. 30, A691.74.
TELZIR 226
S In antiretroviral combination therapy Protease inhibitor. Fosamprenavir 700mg. Pink film for the treatment of HIV-1 infected adults. P 1 once daily with food. Renal impairment (cc 30-49ml/min): 1 every 48 hrs. on one side. 700mg-60, A455.92. Q Under 18 years, not recommended. S HIV-1 infected adults in combination D Pregnancy (unless no alternative), with low dose ritonavir and other antiretroviral lactation. medicinal drugs. P 700mg twice daily with 100mg ritonavir B Renal impairment; not recommended if severe or in haemodialysis. Monitor for signs of twice daily, with other antiretroviral agents. toxicity. Monitor renal function before therapy, R Over 65 years, no data. every 4 weeks during 1st year, then 3 monthly. Q Under 18 years, not recommended. Prexisting liver dysfunction, monitor. HBV/HCV co2N ALSO TELZIR SUSPENSION Fosamprenavir 50mg as infection, monitor several months after stopping fosamprenavir Ca++ (equivalent to approximately drug. Antiretroviral-experienced patients with HIV43mg amprenavir) per ml. Oral suspension. 225ml, 1 with K65R mutation; avoid. Lactic acidosis, lipodystrophy, decreased BMD, osteonecrosis. Child A114.47. P 700mg twice daily with 100mg ritonavir exposed in utero; possible mitochondrial dysfunction. Immune Reactivation Syndrome. twice daily, with other antiretroviral medicinal Contains lactose. products. Take without food on empty stomach. C Avoid co-admin. with nephrotoxic Shake bottle for 20 sec before 1st dose and 5 sec drugs, emtricitabine, tenofovir disoproxil (as before each subsequent dose. fumarate) or other cytidine analogues, eg. R Over 65 years, no data. lamivudine and zalcitabine. Caution: Triple Q Under 18 years, not recommended. nucleoside therapy, didanosine, atazanavir, drugs D Severe hepatic impairment. Pregnancy eliminated by active tubular secretion. (unless essential), lactation. A Neutropenia, allergic reaction, B Mild or moderate hepatic impairment, hypophosphataemia, insomnia, headache, sulphonamide allergy, chronic hepatitis. dizziness, GI disorders, elevated serum lipase and C Substrates of CYP3A4 or CYP2D6 (e.g. flecainide and propafenone), rifampicin, St Johnâ&#x20AC;&#x2122;s amylase, hypertriglyceridaemia, hyperglycaemia, increased liver enzymes, skin disorders, elevated wort, halofantrine, oral contraceptives. Caution: CK, pain. Lopinavir, rifabutin, anticonvulsants, immunosuppresants, TCAs, oral anticoagulants. VALCYTE Roche A Headache, dizziness, GI disorders, rash and fatigue. 2JNT Nucleoside analogue. Valganciclovir (HCl) 450mg. TRIZIVIR GSK Pink oval film-ctd tab. marked VGC one side, 450 2JN on reverse. 60, A1953.95. NRTIs. Abacavir sulph. 300mg, lamivudine 150mg, S Induction and maintenance treatment zidovudine 300mg. Blue-green cap-shaped film-ctd of cytomegalovirus (CMV) retinitis in patients with AIDs. tab. marked GX LL1 one side. 60, A803.57. P 2 twice daily for 21 days with food. S HIV infection in adults. Not for use in patients carrying the HLA-B*5701 allele, unless no Maintenance 2 once daily. R Not recommended. other therapeutic option available. P 1 twice daily. Q Not recommended. Q Under 18 years, not recommended. D Hypersensitivity to aciclovir and D End-stage renal disease, hepatic valaciclovir. Lactation. impairment. Neutrophil counts (Q0.75 x 109/L) or B Women of child bearing potential must Hb level (Q7.5g/dl or 4.65 mmol). Pregnancy, use contraception. Men must use barrier lactation. contraception during treatment and for 90 days B Hypersensitivity reactions. Discontinue if after. Do not initiate therapy if absolute symptomatic hyperlactatemia, metabolic/lactic neutrophil count Q 500 cells/microL, platelet acidosis, or elevating aminotranferase level occur. count Q 25000/microL, Hb Q 8g/dL, pre-existing Co-infection with hepatitis B. or drug relayed haematological cytopenia, patient C Drugs mainly eliminated via cationic receiving radiotherapy. Monitor patients with transport eg trimethoprim. Ganciclovir, foscarnet, renal impairment. Life-threatening adverse phenytoin, aspirin, codeine, morphine, reactions. indomethacin, ketoprofen, naproxen, oxazepam, C Imipenem-cilastatin, didanosine, lorazepam, cimetidine, clofibrate, dapsone, myelosuppressive drugs e.g. zidovudine, drugs isoprinosine. Systemic pentamidine, affecting renal function. pyrimethamine, co-trimoxazole, amphoteracin, A GI upset, anorexia, mouth ulceration, flucytosine, interferon, vincristine, vinblastin, neutropenia, anaemia, thrombocytopenia, dozorubicin. Tribavirin, probenecid. leukopenia, pancytopenia, abnormal hepatic A Nausea, vomiting, diarrhoea, abdominal function, diarrhoea, dermatitis, depression, pain, Headache, elevated liver function tests, anxiety, headache, fatigue. myalgia, dyspnoea, cough, rash, fever lethargy, VALHERP Ergha malaise.
2N
Abbott coated, cap. shaped, biconvex tab., marked GXLL7
2NO Antiviral. Herpes-specific enzyme inhibitor. Valaciclovir (HCl) 500mg. Creamy, oblong film-ctd tab. 10, A18.50; 30, A55.49; 42, A77.66. S Treatment of herpes zoster (shingles). Treatment and prevention (suppression) of herpes simplex infections of skin and mucous membranes, incl. initial and recurrent genital herpes.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES Prophylaxis of cytomegalovirus (CMV) infection and disease, following organ transplantation; Valherp should be used in CMV seronegative patients receiving an organ from a CMV seropositive donor, and considered in CMV seropositive patients at increased risk of developing CMV disease. P Herpes zoster: 1g 3 times daily for 7 days. Herpes simplex: 500mg twice daily. May be extended to 10 days for initial episodes. For recurrent episodes, treatment should be for 5 days. Begin treatment as early as possible; ideally during the prodromal period or immediately after 1st signs or symptoms appear for recurrent episodes. Suppression of recurrences of herpes simplex infections:In immunocompetent patients, 500mg once daily. For immunocompromised HIV infected patients, 500mg twice daily. CMV prophylaxis: 2g four times daily, to be initiated as early as possible post-transplant. Dose should be reduced according to creatinine clearance (see SPC). Treatment duration: 90 days; may be extended in high risk patients. Renal impairment: See SPC. Q CMV prophylaxis: Over 12 years, as per adults. B Caution: Renal impairment, elderly, hepatic impairment and liver transplantation (high doses). Ensure adequate fluid intake in patients at risk of dehydration (particularly the elderly). Use in genital herpes: Safer sex practices also recommended. Pregnancy, lactation. Contains lactose. C Caution at high valaciclovir doses (8g/ day): Ciclosporin, tacrolimus, mycophenolate mofetil. A Nausea, headache.
ANTIVIRAL DRUGS 8.6 organoplatins, iodinated contrast media, methotrexate, pentamidine, foscarnet. Caution at high valaciclovir doses (8g/day): Cimetidine, probenecid, mycophenolate mofetil. A Headache, nausea.
VALTREX
pancreatitis or peripheral neuropathy. Avoid: hydroxyurea, stavudine (not recommended). A Pancreatitis, peripheral neuropathy, headache, fatigue, lipodystrophy, lactic acidosis, GI disorders, haematological disorders, metabolic disorders, asymptomatic hyperuricaemia, blood GSK dyscrasias, retinal depigmentation.
2NO
Antiviral. Herpes-specific enzyme inhibitor. Valaciclovir (HCl) 500mg. White tab. marked GXCF1. Shingles treatment pack-42, A107.12; Herpes simplex treatment pack-10, A25.52; Herpes simplex suppression pack-30, A76.54. S Treatment of Herpes zoster (shingles). Treatment of Herpes simplex infections of skin and mucous membranes incl. initial and recurrent genital herpes; prevention (suppression) of recurrent attacks. Prophylaxis of cytomegalovirus (CMV) infection and disease, following organ transplantation. Valtrex should be used in CMV seronegative patients receiving an organ from a CMV seropositive donor, and considered in CMV seropositive patients who are at increased risk of developing CMV disease (e.g. patients who are treated with high dose immunosuppressants or who receive a second graft from a CMV seropositive donor). P Shingles: 1g three times daily for seven days. Herpes simplex treatment: Begin treatment as early as possible. Initial attack: 500mg twice daily for 10 days. Recurrent attack: 500mg twice daily for 5 days. Herpes simplex treatment prevention: Immunocompetent patients: 500mg once daily or 250mg twice daily. Immunocompromised HIV infected: 500mg twice daily. CMV: 2g four times a day for 90 days, initiated as early as possible post-tranplant. VALOTIX Rowex Impaired renal function, see SPC. Q Not recommended. 2NO B Caution: Severe renal impairment, Antiviral. Herpes-specific enzyme inhibitor. elderly, liver disease. Maintain adequate Valaciclovir (HCl) 500mg. White to off-white cap.- hydration. Use in genital herpes: Safer sex shaped film-ctd tab. with 500 debossed on one practices also recommended. Pregnancy, lactation. side. 10, A19.14. A Mild headache. Nausea. S In immunocompetent patients: Treatment of Herpes zoster in patients q50 years; VIDEX BMS treatment of initial and recurrent genital Herpes 2 N simplex infections. Prophylaxis of cytomegalovirus Nucleoside analogue. Didanosine 125mg, 200mg, (CMV) infection and disease, in particular after 250mg, 400mg. White caps. marked 6671, 6672, renal transplantation, except after lung 6673 or 6674 one half and BMS and strength on transplantation. P Prevention of zoster-associated pain: 1g other. 125mg-30, A82.94; 200mg-30, A130.12; 250mg-30, A165.89; 400mg-30, A265.43. three times daily for 7 days. Initiate asap after S Combination therapy for antiviral start of infection, within 72 hrs of appearance of treatment of HIV infection. skin lesions. Genital herpes simplex: 500mg twice daily for 10 days for initial episode; 1g per day in P Under 60kg, 250mg daily; over 60kg, 400mg daily, as single dose or two doses 12 hrs 1 or 2 divided doses for 5 days for recurrent apart. Take at least 2 hrs before/after meals. episodes. Initiate asap, preferably at prodromal Q Over 6 years, initially 240mg/m2 daily (or stage or when lesions appear. CMV infections 180mg/m2 daily in combination with zidovudine). prophylaxis : 2g four times daily. Initiate asap D Children Q 6 years. after transplant. Adapt dose according to cc (see B Pregnancy, lactation. Renal impairment SPC). Treatment duration: 90 days (longer treatment may be necessary in high risk patients). or neuropathy (adjust dose; see SPC), hepatic impairment. Pancreatitis; monitor serum amylase Renal impairment: See SPC. levels before and during therapy. Monitor Q Prophylaxis of CMV infections: Over 12 triglyceride and liver enzymes. May occur: Lactic years: As per adults. Under 12 years, not acidosis, lipodystrophy, osteonecrosis, immune recommended. B Caution: History of renal impairment, reactivation syndrome. Monitor for mitochondrial elderly, hepatic impairment, liver transplantation. dysfunction. Phenylketonurics, patients on Na+ Maintain adequate hydration. Use in genital restricted diets. Retinal or optical nerve lesions herpes: Safer sex practices also recommended. may occur, consider yearly ophtalmologic Pregnancy, lactation (consider topical treatment). examination. C Caution if impaired renal function C Tenofovir disoproxil fumarate, (regular monitoring recommended): lamivudine, tetracyclines, drugs that affect or are Immunosuppressants, aminoglycosides, affected by gastric pH, ganciclovir. Drugs causing
VIRACEPT
Roche
2N Protease inhibitors. Nelfinavir. tab. 250mg, oral powder 50mg/g. 250mg-300, A483.54; 50mg-144g, A46.41. S HIV infection in combination with other antiretroviral drugs. P 1250mg twice daily or 750mg three times daily. Q 3-13 years, 25-30mg/kg three times daily. See lit. for oral powder. D Lactation. B Impaired renal and hepatic function, patients with phenylketonuria diabetes, haemophilia. C See SPC. A Diarrhoea, nausea, vomiting, flatulence, abdominal pain, rash, elevated creatinine kinase, hepatitis, neutropenia, hypersensitivity reactions.
VIRAFERONPEG
Schering-Plough
2NT Pegylated interferon alfa-2b. Peginterferon alfa-2b (rbe) 50mcg, 80mcg, 100mcg, 120mcg, 150mcg. Powder and solvent for soln. for inj. in pre-filled pen. ViraferonPeg Pen: 50mcg-1, A107.62; 80mcg1, A172.21; 100mcg-1, A215.25; 120mcg-1, A264.68; 150mcg-1, A313.68. S Monotherapy and combination with ribavirin for adult chronic hepatitis C serum HCVRNA positive patients or anti-HCV. P Once weekly SC inj. Dose depends on whether used in combination or as monotherapy. Monotherapy: 0.5-1mcg/kg once weekly for at least 6 months. Combination therapy: 1.5mcg/kg/ week with ribavirin caps. admin. orally each day in 2 divided doses with food morning and evening for at least 6 months. Mono and combination: Continue for additional 6 months in patients showing loss of HCV-RNA at 6 months. See SPC. Q Under 18 years, not recommended. D Autoimmune hepatitis, autoimmune disease, severe psychiatric disorders, thyroid abnormalities, cardiac disease, severe renal or hepatic dysfunction, epilepsy, CNS dysfunction. Pregnancy, lactation. B Monitor patients with CHF, MI, arrhythmias, occular changes. Maintain adequate hydration. Debilitating medical conditions, coagulation disorders, psoriasis. Combination therapy: Mild/moderate impaired renal function, not recommended (monitor for anaemia). Organ transplant recipients: Alone/combination with ribavirin may be associated with increased rate of kidney graft rejection. Liver graft rejection also reported. C Caution: CYP2D6 and CYP2C8/9 substrates, especially those with narrow therapeutic window (eg. warfarin, phenytoin, flecainide). Methadone (consider risk of QTc prolongation). Didanosine with ribavirin not recommended. A Headache, viral infection, fatigue, fever, myalgia, rigors, anorexia, nausea, depression, insomnia, alopecia, flu-like symptoms, inflammation at inj. site. Discontinue if acute
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
227
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
B Monitor renal function. Dosing interval adjustment in patients with cc Q50ml/min. Bone toxicity. Antiretroviral-experienced patients with VIRAMUNE Boehringer Ing. K65R mutation (avoid). Pre-existing liver dysfunction, lactic acidosis. Elderly. Women of 2N child bearing potential, use effective Reverse transcriptase inhibitor. Nevirapine contraception. Pregnancy (if benefit outweighs anhydrate 200mg. White, oval, biconvex tabs. risk). Driving/ operating machines. Contains embossed with 54 above and 193 below score and marked with logo on the other side. 60, A252.36. lactose. C Avoid: Nephrotoxic products and drugs S In combination with other antisecreted via hOAT1 (e.g. cidofovir), didanosine. retrovirals for treatment of HIV-1 infected adults, Caution: Some other antiretrovirals (e.g. lopinavir/ adolescents, and children. ritonavir, atazanavir). P 200mg daily for first 14 days, then A GI disturbances, hypophosphataemia, 200mg twice daily. Take in combination with at dizziness, asthenia, pancreatitis, lactic acidosis, least two other antiretroviral agents. Renal dyspnoea, rash, renal disturbances. dysfunction requiring dialysis: Additional 200mg following each dialysis treatment recommended; ZEFFIX GSK ccr20ml/min, no dose adjustment. 2NT Q 50kg or above, as for adults. Under 50kg, see suspension. Nucleoside analogue. Lamivudine 100mg butterscotch cap-shaped film-ctd tab marked GX 2N CG5. 28, A97.00. ALSO VIRAMUNE SUSPENSION Nevirapine 2NT (hemihydrate) 50mg per 5ml; susp. 240ml (with oral syringe and adaptor), A78.42. ALSO ZEFFIX ORAL SOLUTION Lamivudine 5mg/ P 16 years and older, 20ml once daily for ml; soln. 240ml, A36.59. 1st 14 days, then 20ml twice daily, taken in S Chronic hepatitis B and evidence of viral combination with at least two other replication in patients with decompensated liver antiretrovirals. Renal dysfunction requiring dialysis: disease or active liver inflammation and/or fibrosis. Additional 200mg following each dialysis P 100mg once daily. See data sheet for treatment recommended; ccr20ml/min, no dose treatment duration. adjustment. Q Under 16 years, not recommended. Q Dose by body surface area or body D First trimester of pregnancy, lactation. 2 weight. Under 8 years, 4mg/kg or 150mg/m once B Renal impairment, co-infection with daily for 2 weeks, then 7mg/kg or 150mg/m2 twice delta hepatitis or hepatitis C, cancer chemotherapy, transplant patients, HIV patients, daily; 8-16 years, 4mg/kg or 150mg/m2 once daily for 2 weeks, then 4mg/kg or 150mg/m2 twice daily. advanced liver disease, diabetes. Monitor levels of ALT every 3 months, HBV DNA and HBsAg every 6 Max. 400mg daily. months. D Severe hepatic impairment. PreC Trimethoprim, sulphamethoxazole. treatment ASAT or ALATq5ULN. St Johnâ&#x20AC;&#x2122;s Wort, A Malaise, fatigue, RTIs, sore throat, rifampicin. Previous rash, rash with constitution headache, abdominal pain, GI disturbance. symptoms. Lactation. B Monitor for severe rash or rash with ZERIT BMS fever, blistering, oral lesions, swelling, conjunctivitis, facial oedema, muscle or joint pain, 2 N malaise; discontinue. Monitor blood chemistry, Reverse transcriptase inhibitor. 20mg brown cap.; incl. liver function, before and during treatment; 30mg light orange/dark orange cap.; 40mg dark discontinue with moderate or severe liver function orange. All marked with company initials, code abnormalities. Do not initiate if CD4 q250 cells/ and cap. strength. 20mg-56, A226.29; 30mg-56, mm3 in adult females or q400 cells/mm3 in adult A234.63; 40mg-56, A242.82. males. Renal or hepatic impairment. Pregnancy. S HIV infection in combination with other Contains lactose (tabs). antiretroviral. C Drugs affecting cyt. P450 eg. efavirenz, P Under 60kg, initially 30mg twice daily; indinavir, lopinavir, methadone, cimetidine (adjust over 60kg, initially 40mg twice daily. Take 1 hr dose). Rifampicin, ketoconazole (not before meals. recommended). Fluconazole, warfarin (monitor Q Under 30kg, 1mg/kg twice daily; over closely). Oral contraceptives (barrier contraception 30kg, adult dosing. taken 1 hr before meals. Take recommended). 1 hr before meals A Rash, hypersensitivity, GI disorders, 2N headache, myalgia, fever, fatigue, hepatitis, ALSO ZERIT POWDER Stavudine 200mg. Powder abnormal liver function, hepatitis, for oral soln. 200ml, A37.13. granulocytopenia. P Under 60kg, initially 30mg twice daily; over 60kg, initially 40mg twice daily. Take 1 hr VIREAD Gilead before meals. 2N Q Birth-13 days, 0.5mg/kg twice daily; 14 Nucleotide reverse transcriptase inhibitor (NtRTI). days-30kg, 1mg/kg twice daily; over 30kg, adult Tenofovir disoproxil fumarate 300mg (equiv. dosing. Take 1 hr before meals. tenofovir disoproxil 245mg). Light blue, almondD Pregnancy (unless clearly necessary), shaped, film-ctd tab. marked GILEAD 4331 one lactation. Lactose intolerance (caps). side 300 on reverse. 30, A490.60. B Renal impairment (see SPC), elderly, S In combination with other antiretroviral history of pancreatitis. Peripheral neuropathy agents for the treatment of HIV-1 infected adults. (switch therapy if develops), lactic acidosis, liver disease (discontinue if ALT/ASTq5xULN), immune P 1 once daily with food. reactivation syndrome, lipoatrophy, osteonecrosis Q Under 18 years, not recommended. reported. Powder contains sucrose. D Lactation. hypersensitivity, prolongation of coagulation markers, or severe CNS effects occur.
228
C Hydroxyurea, zidovudine (avoid), doxorubicine, ribavirin (caution). A Raised ALT/AST, lactic acidosis, hepatitis, lipodystrophy, headache, fatigue, GI/CNS disorders, skin irritations. Lymphadenopathy, neoplasia.
ZIAGEN
GSK
2JN NRTI. Abacavir sulph. 300mg. Yellow film-ctd capshaped tab. marked GX623 one side. 60, A341.98.
2JN ALSO ZIAGEN ORAL SOLUTION Abacavir sulph. 20mg/ml. 240ml, A98.18. S Antiretroviral combination therapy for the treatment of HIV infection. Not for use in patients carrying the HLA-B*5701 allele, unless no other therapeutic option available. P 300mg twice daily or 600mg once daily. Q Under 3 months, not recommended; 3 months-12 years, 8mg/kg body weight twice daily. Max. 600mg daily. D Severe hepatic impairment. Pregnancy, lactation. B Monitor closely for hypersensitivity reactions (discontinue immediately). Symptomatic hyperlactatemia, metabolic/lactic acidosis, hepatomegaly, rapidly elevating hyperlactatemia, co-infected with hepatitis C. Hepatic or renal impairment. C Methadone, phenobarbital, rifampicin, phenytoin. A Rash, nausea, anorexia, vomiting, diarrhoea, abdominal pain, dyspnoea, cough, fever, lethargy, malaise, headache, elevated liver function tests, myalgia.
ZOVIRAX
GSK
2NO Herpes-specific enzyme inhibitor. Aciclovir 800mg. White, biconvex, elongated film-ctd tab. marked GX CG1 on one face. 35, A130.36. S Treatment of acute herpes zoster infections. P 1 five times daily at 4 hourly intervals for 7 days. Tab. may be swallowed whole or dispersed in water. Q Not applicable.
2NO ALSO ZOVIRAX DOUBLE STRENGTH SUSPENSION Aciclovir 400mg/5ml. 100ml, A30.82. S Treatment of varicella (chickenpox). P As for Zovirax 800mg above. Q Dosage four times daily for 5 days. 0-2 years, 2.5ml. 2-6 years, 5ml. 6-12 years, 10ml. Dosage based on 20mg/kg body weight (not to exceed 800mg) four times daily.
2NO ALSO ZOVIRAX 200MG Aciclovir 200mg. Blue shield-shaped tab. marked ZOVIRAX and with triangle. 25, A33.56.
2NO ALSO ZOVIRAX SUSPENSION Aciclovir 200mg/5ml. 125ml, A33.33. S Treatment and long term suppression of herpes simplex infections of skin and mucous membranes. Prophylaxis in immunocompromised patients. P Treatment: 200mg five times daily at 4 hourly intervals for 5 days. Prophylaxis, (immunocompromised) suppression: 200mg 4 times daily at 6 hourly intervals. Q Treatment: under 2 years, 2.5ml susp. five times daily, for 5 days. Over 2 years, same as adult. Prophylaxis: under 2 years, 100mg four
2
5
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Prohibited
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Restricted b2 agonists
Declaration required
IMMUNOLOGY
VACCINES
AND IMMUNOGLOBULIN PRODUCTS
15mcg of each per 0.5ml. Susp. in pre-filled syringe. 1, A3.00. S Prophylaxis of influenza, especially in 2JN those over 65 years and those who run an ALSO ZOVIRAX INFUSION Aciclovir 250mg. increased risk of associated complications. Powder in vial. 5, A72.82. V 6-35 months, clinical data limited, doses S Herpes simplex and varicella zoster of 0.25ml or 0.5ml have been used; adults and infections in normal and immunocompromised children from 36 months, 0.5ml. For children not patients. previously vaccinated a second dose should be V 5mg/kg body weight every 8 hours or given after an interval of 4 weeks. All by IM or 10mg/kg body weight every 8 hours in deep SC inj. immunocompromised patients with varicella D Allergy to eggs. Febrile illness, acute zoster. Both by slow IV inf. infection. B Renal impairment. Maintain adequate B Pregnant high risk patients (weigh risk hydration. of clinical infection against possible vaccination C Probenecid. A Neurological reactions and rashes. Renal risk). Response in patients with endogenous/ iatrogenic immunosuppresion may be insufficient. impairment with Zovirax IV. Not for intravascular use. 9.1 VACCINES AND IMMUNOGLOBULIN A Local reactions, fever, headache, malaise, shivering, fatigue, sweating, myalgia, PRODUCTS arthralgia (transient, disappearing within 1-2 days ACT-HIB Sanofi Pasteur MSD of treatment completion). times daily at 6 hourly intervals. Over 2 years, same as adult.
9.1
S Booster vaccination against diphtheria, tetanus and pertussis. Not intended for primary immunisation.
2N
ALSO IPV-BOOSTRIX Diphtheria toxoid r2 IU, tetanus toxoid r20 IU, pertussis toxoid 8mcg, filamentous haemagglutinin 8mcg, pertactin 2.5mcg, inactivated poliovirus types 1, 2, 3. Turbid white susp. for inj. in pre-filled syringe. Price on request. S Booster vaccination against diphtheria, tetanus, pertussis and poliomyelitis. Not intended for primary immunisation. P Single 0.5ml dose by deep intramuscular inj. preferably in deltoid region. Q Under 4 years, not recommended. Over 4 years, as per adults. D Hypersensitivity after previous admin. of similar vaccine. Encephalopathy within 7 days following previous pertussis-containing vaccine. Transient thrombocytopenia or neurological complications following earlier immunisation against diphtheria and/or tetanus. Acute severe 2N AVAXIM Sanofi Pasteur MSD febrile illness. Inactivated surface antigen. Capsular B Review medical history (previous polysaccharide of H. influenzae type b conjugated 2 N vaccination and occurrence of undesirable events). Inactivated vaccine. Inactivated hepatitis A virus to tetanus protein 10mcg/0.5ml. Powder in vial Caution: To r 40oC, collapse or shock-like state, or plus diluent in amp. 10 x 0.5ml, price available on 160 antigen units per 0.5ml. Susp. in pre-filled crying for r 3 hours (all within 48 hrs of syringe. Price available on request. request. vaccination with pertussis containing vaccine), S Active immunisation against infection S Active immunisation against invasive convulsions within 3 days; bleeding disorder, caused by hepatitis A virus. diseases caused by H. influenzae type b such as thrombocytopenia. New onset or progression of P 0.5ml by IM inj. in the deltoid region. A meningitis and epiglottitis. severe neurological disorder. Do not admin. booster should be given 6-12 months later. P Not applicable. intravascularly. Pregnancy (avoid), lactation. Q Under 16 years, not recommended. Q Under 2 months, not recommended. 2A Somnolence, anorexia, pyrexia, inj. site D Severe febrile infections. Pregnancy, 12 months, three separate inj. each of 0.5ml by reactions and pain, oedematous swelling of lactation. deep SC or IM inj. at intervals of 4 weeks usually injected limb, irritability, headache, fatigue, GI at the same time as DTP immunisation. 13 months- B Hypersensitivity to neomycin. Liver disorders. disease. 4 years, 0.5ml as a single dose. A Mild local pain, asthenia, myalgia, D Acute infections. CERVARIX GSK headache, GI disorders, mild fever. A Local erythema.
2N
AGRIPPAL
Chiron Vaccines
BOOSTRIX
GSK Viral Vaccine. Human Papillomavirus (HPV) L1
2N
2N
Inactivated surface antigen. Influenza virus A/New Caledonia/20/99 (H1N1)-like strain (A/New Caledonia/20/99 IVR-116), A/Moscow/10/99 (H3N2)like strain (A/Panama/2007/99 RESVIR 17), B/Hong Kong/330/2001-like strain (B/Shangdong/7/97);
Vaccine. Diphtheria toxoid r2 IU, tetanus toxoid r20 IU, pertussis toxoid 8mcg, filamentous haemagglutinin 8mcg, pertactin 2.5mcg. Turbid white susp. for inj. in pre-filled syringe. Price on request.
PRESCRIBING NOTES VACCINES AND IMMUNOGLOBULINS Vaccines and immunoglobulins are used to confer either active or passive immunity in individuals. Passive immunity is achieved with immediate protection, it is produced by immunoglobulins, which are antibodies of human origin. They are divided into two classes, normal immunoglobulins prepared from pooled human plasma, (e.g. those providing protection from Hepatitis A and measles) and specific immunoglobulins prepared from the plasma of immunised donors with adequate levels of antibodies to the disease for which protection is sought (e.g. hepatitis B, tetanus, varicella zoster, rabies and sensitivity to the Rh antigen). Immediate protection is only short term, lasting no more than a couple of months. Adverse reactions to human immunoglobulins are possible but are rare in practice. Viral immunoglobulins are produced in tissue cultures that may contain antibiotics, or are produced in chick embryos. Patients with allergies to these should not be given these vaccines. Active immunity achieved using vaccines, is slower in onset than the passive immunity but the immunity lasts for many years or even life. Vaccines are of three types. Live attenuated, which contain an attenuated strain of the micro-organism or virus are intended to cause a sub-clinical infection from which they confer future immunity. Inactivated preparations of micro-organisms and viruses, may contain the intact organism (hepatitis A, typhoid, rabies), or specific antigens (influenza, hepatitis B). They may require a series of injections and boosters to ensure adequate immunity. Bacterial toxins, which have been inactivated, are also used as vaccines (e.g. tetanus and diphtheria). A series of injections and boosters are required to provide continuing immunity. These provide better protection when they are adsorbed on an adjuvant, commonly aluminium hydroxide. References available on request
protein type 16, 20mcg; type 18, 20mcg. Susp. for inj. in pre-filled syringe. Price available on request. S The prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 in girls and women. P Recommended vaccination schedule is 0, 1, 6 months; admin by IM inj. in the deltoid region. Subjects who receive a 1st dose should complete the 3-dose course. Q Under 10 years, not recommended. Over 10 years, as per adults. D Acute severe febrile illness. B Do not admin. intravascularly or intradermally. SC admin., no data. Impaired immune responsiveness, no data. Rare anaphylactic events may occur. Caution: Thrombocytopaenia or any coagulation disorder due to bleeding risk following IM inj. Not a substitute for regular cervical screening or for precautions against exposure to HPV and STDs. Protects against disease caused by HPV types 16 and 18 only. Not indicated for treatment of cervical cancer, cervical intraepithelial neoplasia (CIN) or any other established HPV-related lesions. Does not prevent HPV-related lesions in women who are infected with HPV-16 or HPV-18 at the time of vaccination. Duration of protection unknown. Timing and need of booster has not been investigated. A protective immune response may not be elicited in all vaccines. No data to support interchangeability with other HPV vaccines. Pregnancy (postpone vaccination).
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
229
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IMMUNOLOGY
AND IMMUNOGLOBULIN PRODUCTS
C Immunosuppressive treatment. Admin. other injectable vaccines at different inj. sites. A Headache, nausea, vomiting, diarrhoea, abdominal pain, itching/pruritus, rash, urticaria, myalgia, arthralgia, inj. site reactions, fatigue, fever.
A Headache, GI disorder, pain, fatigue, fever, redness, injection site swelling.
Monodose.
FLUARIX
ALSO HAVRIX JUNIOR MONODOSE Hepatitis A
2
Inactivated split viron. Influenza virus. Complies with WHO recommendation (northern ENGERIX B GSK hemisphere) and EU decision for the current 2N season. See SPC. Susp. in pre-filled syringe. Price available on request. Genetically derived surface antigen. Hepatitis B S Prophylaxis of influenza. surface antigen 20mcg/ml adsorbed onto alum. hydrox. Susp. in single dose prefilled syringe. 1ml- V 0.5ml by IM or deep SC inj. 6-35 months: 0.25-0.5ml and repeat after min. 4 weeks if not 1, 0.5ml-1; prices available on request. S Active immunisation against hepatitis B previously vaccinated. D Hypersensitivity to egg, to chicken virus particularly for those exposed to blood protein, formaldehyde, gentamicin sulphate, Na+ products or in high endemic areas. Booster or to complete course in patients previously immunised deoxycholate. Febrile illness or acute infection with other hepatitis B vaccines. (postpone). P 1ml by IM inj. into the deltoid muscle, B Not to be administered intravascularly. repeated 1 month and 6 months later. Where Pregnancy. more rapid immunisation is needed, repeat at 1 A Local reactions, fever, malaise, month and 2 months, with a booster at 12 headache. months. Booster doses as required after 2 or more GARDASIL Sanofi Pasteur MSD years. Immunocompromised and dialysis patients: 40mcg (2ml) in 1ml volumes at different sites, 2 repeated at 1 month and 6 months later. Booster Viral Vaccine. Human Papillomavirus (HPV) L1 doses as required. In exceptional circumstances the protein type 6, 20mcg; type 11, 40mcg; type 16, following schedule may be used: 0, 7, 21 days 40mcg; type 18, 20mcg. Susp. for inj. in pre-filled followed by a booster at 12 months. syringe. 0.5ml-1, price available on request. Q 0-15 years: 10mcg (0.5ml) IM repeated S Vaccine for the prevention of highat 1 month and 6 months. In neonates born to grade cervical dysplasia (CIN 2/3), cervical HBsAG positive mothers, hepatitis B immunoglobin carcinoma, high-grade vulvar dysplastic lesions may be given simultaneously at different sites (VIN 2/3), and external genital warts (condyloma within a few hours of birth. Over 16 years same as acuminata) causally related to HPV types 6, 11, 16 adults. and 18 in 16-26 year old females and 9-15 year D Severe febrile infections. old children and adolescents. B Cardiac or pulmonary insufficiency; P 3 separate 0.5 ml doses admin. by IM debilitated patients; those for whom a systemic inj. at 0, 2, and 6 months. If alternate vaccination reaction might be a serious risk. Adrenaline 1:1000 schedule necessary, admin. 2nd dose r 1 month should be available in case of anaphylaxis. after 1st dose and 3rd dose r 3 months after 2nd Haemodialysis, immunocompromised. Pregnancy. dose. All 3 doses should be given within a 1-year See SPC. period. Need for booster has not been established. A Mild transient local soreness, erythema Preferred site: Deltoid area or higher anterolateral and induration at inj. site. Low grade fever, area of thigh. malaise, fatigue, headache, nausea, dizziness. See Q Under 9 years, not recommended. Over SPC. 9 years, as per adults. D Acute severe febrile illness. Must not inj. FENDRIX GSK intravascularly. B Not indicated for treatment of cervical 2N cancer, high-grade cervical, vulvar and vaginal Inactivated surface antigen. Hepatitis B surface dysplastic lesions or genital warts. Not a substitute antigen 20mcg adjuvanted by AS04C and for routine cervical screening. Impaired immune adsorbed on aluminium phosphate. Turbid white responsiveness (no data). Caution: suspension for inj. in a pre-filled syringe. 1, price Thrombocytopaenia or any coagulation disorder on request. S Active immunisation against hepatitis B due to bleeding risk following IM inj. Duration of virus infection (HBV) caused by all known subtypes protection unknown; observed for 4.5 years after for patients with renal insufficiency (including pre- completion of 3-dose series. Protective efficacy has not been evaluated in males. Pregnancy (postpone haemodialysis and haemodialysis patients), from vaccination). the age of 15 years onwards. A Pyrexia, injection site reactions including P 0.5ml by IM inj. in the deltoid region, erythema, pain, swelling, bleeding, pruritus. repeated 1 month, 2 months and 6 months later. Q Under 15 years, not recommended. D Hypersensitivity after previous administration of other hepatitis B vaccines. Acute severe febrile illness. B Will not prevent infection caused by hepatitis A, hepatitis C and hepatitis E or other pathogens known to infect the liver. Immune response to hepatitis B vaccines may be reduced by old age, male gender, obesity, smoking, admin. route, some chronic underlying diseases. Do not inject intradermally or intravenously. Avoid IM admin. into the gluteal muscle. Pregnancy, lactation (use only if benefits outweigh risks).
230
2N
GSK virus HM175 strain 720 ELISA units/0.5ml adsorbed
HAVRIX MONODOSE
GSK
2N Inactivated virus. Hepatitis A vaccine (HM175 strain) 1440 ELISA units/1ml adsorbed on alum. hydrox. Prefilled syringe. 1ml-1; price available on request. S Active immunisation against hepatitis A. P Over 16 years, primary immunisation: 1ml. Booster: 1ml, any time between 6 months and 5 years following initial dose. All by IM inj. into deltoid muscle. Q Under 16 years, use Havrix Junior
on alum. hydrox. Prefilled syringe. 0.5ml-1; price available on request. Q Under 1 year, not recommended. 1-15 years, primary immunisation: 0.5ml, protects for up to 5 years. Booster: 0.5ml, any time between 6 months and 5 years following initial dose. All by IM inj. into the deltoid muscle. In patients with haemorrhagic disorders consider SC inj. D Severe febrile infections. B Pregnancy, lactation. Haemodialysis, impaired immune system may require additional doses of vaccine. A Mild transient soreness, erythema and induration at inj. site, headache, fever, malaise, fatigue, nausea, vomiting, diarrhoea, loss of appetite, rash. Sleeping and feeding problems (young children only). See SPC.
HBVAXPRO
Sanofi Pasteur MSD
2N Recombinant vaccine. Hepatitis B virus surface antigen, recombinant (HBsAg) 10mcg/ml. Susp. in vial. Price available on request. S Active immunisation of adults and adolescents 16 years and over against hepatitis B virus. P 1ml by IM inj. into the deltoid muscle repeated 1 month and 6 months later. Rapid immunisation, 1 ml by IM inj. repeated 1 month, 2 months and 12 months later. Q Under 16 years, not recommended.
2N ALSO HBVAXPRO 40MCG/ML Hepatitis B virus surface antigen, recombinant (HBsAG) 40mcg/ml. Susp. in vial. Price available on request. S Active immunisation against hepatitis B virus in predialysis and dialysis patients. P 1ml by IM inj. into the deltoid muscle repeated 1 month and 6 months later. A booster dose may be given if antibody level Q10 IU/L. Q Not recommended.
2N ALSO HBVAXPRO 5MCG/ML Hepatitis B virus surface antigen, recombinant (HBsAg) 5mcg/0.5ml. Susp. in vial. Price available on request. S Active immunisation of children and adolescents up to and incl. 15 years of age against hepatitis B virus. P Not recommended. Q 0.5ml by IM inj. into the deltoid muscle repeated 1 month and 6 months later. 0.5ml by IM inj. repeated 1 month, 2 months and 12 months later. D Severe febrile illness. B May occur: Apnoea in very premature infants. Pregnancy. A Local reactions, eczema, polyarteritis nodosa.
HEPATECT
Intra Pharma
2N IV immunoglobulin. Human hepatitis B Ig. Inj. Amps-2ml, A123.75; 10ml, A530.36. S Postexposure prophylaxis following parenteral exposure, direct mucous membrane contact or oral ingestion of hepatitis B positive material. Prophylaxis in newborns of HBs-antigen positive mothers, dialysis patients or those receiving multiple transfusions of blood components.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
IMMUNOLOGY
VACCINES
AND IMMUNOGLOBULIN PRODUCTS
unknown aetiology within 7 days of previous pertussis vaccination.Acute severe febrile illness. B Thrombocytopenia or bleeding disorder. History of febrile convulsions. Apnoea in very HEPATYRIX GSK premature infants. Events following previous pertussis vaccine (e.g. temperature r40oC; 2N collapse/shock-like state; persistent, inconsolable Inactivated virus/surface antigen. Hepatitis A crying; convulsions). Rate of febrile reactions vaccine (HM 175 strain) 1440 ELISA units/ml. Vi higher when co-administered with pneumococcal polysaccharide of Salmonella typhi (Ty2 strain) conjugated vaccine - mostly moderate 25mcg/ml. Susp. for inj. in prefilled syringe. 1ml-1; saccharide (R39oC) and transient. Not for intravascular or price available on request. intradermal administration. S Active immunisation against Hepatitis A A GI disorders, loss of appetite, fever, virus infection and typhoid fever of adults and fatigue, pain, redness, inj.site reactions (incl. adolescents 15 years of age and over. induration, local swelling), abnormal crying, P 15 years and older, primary irritability, restlessness, nervousness. immunisation: 1ml. Booster: 1ml inactivated Hepatitis A vaccine 6-12 months following initial INFANRIX-IPV HIB GSK dose. Subjects at risk for typhoid fever: 1 single 2N does of Vi polysaccharide vaccine every 3 years. Q Under 15 years, not recommended. Toxoid vaccine. Diphtheria toxoid q30 IU, tetanus D Acute febrile disease. Hypersensitivity to toxoid q40 IU, pertussis 25mcg, filamentous neomycin. haemagglutinin 25mcg, pertactin 8mcg, poliovirus B Pregnancy, lactation. Impaired immune inactivated type 1: 40D antigen units, type 2: 8D system (may require additional doses.) antigen units and type 3: 32D antigen units, A Pain, erythema, swelling at inj. site. purified capsular polysaccharide of Hib 10mcg and Malaise, headache, general aches, nausea, itching. conjugated to tetanus toxoid approximately 30mcg per 0.5ml. Powder for susp. for inj. in HIBERIX GSK single dose vial and prefilled syringe. Price available on request. 2N S Active immunisation against diphtheria, Inactivated vaccine. Capsular polysaccharide of Haemophilus influenzae type b, covalently bound tetanus, pertussis, poliomyelitis and H. influenzae type b disease from the age of 2 months. Not to tetanus toxoid (PRP-T) 10mcg per 0.5ml. Pellet suitable for children over 36 months. in vial with diluent in amp. Price available on Q 0.5ml by deep IM inj. Primary request. vaccination schedule: 2 or 3 doses from the age of S Active immunisation against disease 2 months. At least 4 weeks interval between caused by Haemophilus influenzae type b in subsequent doses. Booster vaccination: After infants from the age of two months. primary vaccination with 2 doses, booster must be P Not applicable. given at least 6 months after last priming dose, Q Primary immunisation starts at two months of age and consists of three doses with an preferably between 11 and 13 months of age. interval of two months between each dose. 0.5ml After primary vaccination with 3 doses, a booster dose of Hib conjugate vaccine (monovalent or by IM inj. combined) must be administered with a timing in D Severe febrile illness. B In subjects with thrombocytopenia and accordance with official recommendations. D Known hypersensitivity to neomycin, bleeding disorders, deep SC admin. may be polymyxin and polysorbate 80. Encephalopathy of considered. A Local reactions, mild erythema, pain and unknown aetiology within 7 days following mild swelling, fever, loss of appetite, restlessness, previous vaccination with pertussis containing vomiting, diarrhoea, unusual crying. vaccine. Acute severe febrile illness. B Risk of apnoea in very premature INFANRIX HEXA GSK infants. Caution: Events following previous pertussis vaccine (e.g. temperature r40oC; 2N collapse/shock-like state; persistent, inconsolable Toxoid/inactivated/genetically-derived surface crying; convulsions). antigen/polysaccharide conjugate vaccine. A Pain, swelling, redness at inj. site, fever, Diphtheria toxoid r30IU; tetanus toxoid r40IU; unusual crying, vomiting, diarrhoea, loss of pertussis toxoid 25mcg, filamentous haemagglutinin 25mcg, pertactin 8mcg; hepatitis B appetite, restlessness, nervousness, somnolence. surface antigen 10mcg; inactivated poliovirus type Solvay 1 40D-antigen unit, type 2 8D-antigen unit, type 3 INFLUVAC 2N 32D-antigen unit; Haemophilus type b polysaccharide 10mcg. Powder in vial and susp. for Inactivated surface antigen. Influenza virus A/ inj. in pre-filled syringe. 10. Price available on Wisconsin/67/2005 (H3N2)-like (A/Hiroshima/52/2005 request. IVR-142 reass.) A/New Caledonia/20/99 (H1N1)-like (A/New Caledonia/20/99 IVR-116 reass.) B/Malaysia/ S Primary and booster vaccination of 2506/2004-like strain (B/Malaysia/2506/2004). infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and H. influenzae type b. 15mcg of each per 0.5ml. Pre-filled syringe. 1 single unit. Price available on request. P Not applicable. Q Primary vaccination schedule: 3 doses of S Prophylaxis of influenza. 0.5ml by deep IM injection. Booster doses: In V From 36 months, 0.5ml; 6-35 months, accordance with official recommendations. Not clinical data limited, doses of 0.25-0.5ml have been intended for children over 36 months. used. For children not previously vaccinated or D Hypersensitivity to neomycin, polymyxin infected a second dose should be given after at or previous diphtheria, tetanus, pertussis, hepatitis least 4 weeks. IM or deep SC inj. should be used. B, polio or Hib vaccines. Encephalopathy of D Allergy to eggs, poultry, gentamycin V By IV inj. only. See SPC. B Live vaccines. C Live vaccines.
9.1
and other vaccine contents. Febrile illness. Acute infection. B Anaphylaxis (rare). Immunnosuppressed patients. A Fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia, local reactions.
INTRAGLOBIN F
Intra Pharma
2N IV immuoglobulin. Human normal Ig 5%. Soln. in amp. and inf. in bottle. Amp.-20ml, A94.48; Inf. bottles-50ml, A160.62; 100ml, A306.12; 200ml, A600.90. S Replacement therapy for primary and secondary immunodeficiency states incl. congenital agammaglobinaemia and hypogammaglobinaemia. Idiopathic thrombocytopenic purpura in adults or children at high risk of bleeding or prior to surgery to correct platelet count. Prophylaxis of recurrent bacterial infection in children with symptomatic HIV infection. V Replacement therapy: 100-400mg/kg every 2-4 weeks.Thrombocytopenic purpura400mg/kg by IV inf. on five successive days. Maintenance, 400mg/kg as required. D Selective IgA deficiencies. B Monitor for signs of anaphylactoid reactions during inf. C Live vaccines. A Headache, fever, chills, nausea, vomiting, allergic reactions, rash, arthralgia, back pain. Rarely, hypotension.
M-M-RVAXPRO
Sanofi Pasteur MSD
2N Live attenuated virus. Measles vaccine (Enders attenuated Edmonston strain) 1000 CCID50, mumps vaccine (Jeryl Lynn strain) 12500 CCID50, rubella vaccine (Wistar RA27/3 strain) 1000 CCID50 per dose. Powder and solvent for suspension for inj. in pre-filled syringe. Price on request. S Active immunisation against measles, mumps and rubella. V Over 12 months: One dose inj. IM or SC at elected date. If no response, 2nd dose may be admin. at least 4 weeks after 1st dose. Thrombocytopenia, coagulation disorder: Admin. SC. Under 12 months, no data. D Pregnancy (within 3 months of vaccination), hypersensitivity to neomycin, immunodeficiency, febrile illness, untreated TB, blood dyscrasias, leukaemia, lymphomas of any type. B Hypersensitivity to eggs, family history of convulsions, history of cerebral injury, thrombocytopenia. Contains sucrose, traces of recombinant human albumin. C Contra: Immunosuppressive therapy. Defer blood or plasma transfusions or admin. of human immune serum globulin for 3 months. Do not give within 1 month of other live vaccines. Tuberculin skin test. A Inj. site reaction, fever, rash.
MENINGITEC
Wyeth
2N Conjugate vaccine. Meningococcal group C oligosaccharide 10mcg conjugated to Corynebacterium diphtheriae CRM197 protein approx. 15mcg/0.5ml. Susp. for injection in PFS. 10; price on request. S Active immunisation for prevention of
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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9.1 VACCINES
IMMUNOLOGY
AND IMMUNOGLOBULIN PRODUCTS patients who stabilised idiopathic thrombocytopenic purpura.
hypersensitivity reactions if history of anaphylactic, anaphylactoid, or other immediate reactions to eggs; vaccinate with extreme caution. Do not PREVENAR Wyeth administer intravascularly. C Do not give within 1 month of other 2N live vaccines, or within 3 months of blood Conjugate vaccine. Pneumococcal saccharide transfusion or human gammaglobulins. conjugate vaccine containing 2mcg each of A Local redness/pain/swelling, fever, URTIs, saccharide serotypes 4, 9V, 14, 18C, 19F, 23F and rash. 4mcg of saccharide 6B/0.5ml conjugated to CRM197 carrier protein and adsorbed on alum. RABIES VACCINE Sanofi Pasteur MSD phos. Susp. for inj. in vial and prefilled syringe. 2N Price available on request. S Active immunisation against disease Inactivated virus. Wistar rabies strain PM/WI 38 (incl. sepsis, meningitis, pneumonia, bacteraemia 1503-3M 2.5 IU/ml. Powder in vial plus WFI. Price and acute otitis media) caused by the strains of available on request. Streptococcus pneumoniae contained in the S Prophylaxis and treatment of rabies. vaccine. Prophylaxis, 3 doses of 1ml by deep SC or IM inj. P Not applicable. on days 0, 7 and 28. Avoid gluteal region; use Q By IM inj. 2-6 months, 3 doses starting deltoid region. Reinforcing doses of 1ml once at 2 months of age with at least 1 month interval every 2-3 years. Treatment, if previously primed, 2 between doses, a 4th dose is recommended in 2nd doses of 1ml at day 0 and between days 3-7 after year of life; Routine infant immunisation contact with infected animal. If no previous programme: 1st dose at 2 months, 2nd dose at prophylaxis, 1ml by SC or IM inj. as soon as least 2 months later, 3rd (booster) dose at 11-15 possible after contact with infected animal and 5 further doses of 1ml given on days 3, 7, 14, 30 months ; 7-11 months, 2 doses with at least 1 and 90. month interval between doses, a 3rd dose MENJUGATE Sanofi Pasteur MSD recommended in 2nd year of life; 12-23 months, 2 A Local reactions, fever, malaise. 2N doses with interval of at least 2 months between REVAXIS Sanofi Pasteur MSD Conjugated vaccine. Meningococcal group C doses; 24 months-5 years, one single dose. The oligosaccharide 10mcg conjugated to need for a booster dose after these immunisation 2 N Corynebacterium diphtheriae CRM197 protein schedules has not been established. Toxoid/inactivated vaccine. Diphtheria toxoid q2 12.5-25mcg per 0.5ml. Powder and solvent for D Acute febrile illness. Hypersensitivity to IU, tetanus toxoid q20 IU, inactivated susp. in vials or in kit (vial and syringe). Prices diphtheria toxoid. poliomyelitis vaccine per 0.5ml dose. Susp. for inj. available on request. B Immunocompromised patients may have in pre-filled syringe. Price available on request. S Active immunisation of children (from 2 reduced antibody response. Immune response has S Active immunisation against diphtheria, been demonstrated in infants with sickle cell months), and adults, for prevention of invasive tetanus and poliomyelitis in adults and disease caused by Neisseria meningitidis serogroup disease. Other high-risk groups, data not available. adolescents, as a booster following primary Vaccination in high-risk groups should be C. vaccination. considered on an individual basis. Prophylactic V Under 12 months, three doses each of P 0.5ml admin. by IM inj. in deltoid antipyretic medication recommended for children region, under certain conditions may be given by 0.5ml by deep IM inj. in anterolateral thigh, 1st receiving simultaneous vaccines containing whole SC inj. Booster doses according to local dose given not earlier than 2 months and with cell pertussis and/or with seizure disorders or interval of at least 1 month between doses; over recommendation. history of febrile seizures. Do not admin. 12 months, single 0.5ml dose by deep IM inj. in Q Over 6 years, as per adults. intravenously. Protection against all otitis media deltoid region. Do not mix with other vaccines. D Hypersensitivity to neomycin, expected to be low. See SPC. Use separate inj. site if more than one vaccine is streptomycin or polymyxin B. Acute severe febrile C MnCC vaccines (no data but possible admin. illness. Neurological complications following an immune interference). D Acute severe febrile illness. earlier immunisation against diphtheria and/or A Local reactions, fever. B Pregnancy, lactation, elderly. tetanus. Pregnancy (unless necessary). C Hepatitis B and pneumococcal B Not for IV admin. Patients having a PRIORIX GSK primary vaccination course or having received a conjugate vaccines (only if medically important). A Inj. site reactions, fever. Irritability, booster containing diphtheria or tetanus toxoid, 2N drowsiness, impaired sleeping, crying, anorexia, during the 5 years preceding. Thrombocytopenia Live attenuated virus. Measles virus (Schwarz diarrhoea, vomiting in younger children, strain) at least 103.0 CCID503, mumps virus (RIT 4385 or a bleeding disorder headache, malaise, myalgia and arthralgia in older strain derived from Jeryl Lynn strain) at least 103.7 C Immunosuppressive agents. recipients. A Pain, erythema, induration, oedema, CCID503, rubella virus (Wistar RA 27/3 strain) at fever, malaise, headache, vertigo, nausea/vomiting, least 103.0 CCID503. Powder in vial and solvent in PNEUMOVAX II Sanofi Pasteur MSD pyrexia. pre-filled syringe. 10. Price available on request. 2N S Active immunisation of children 11 ROTARIX GSK Pneumococcal vaccine. Purified mix of capsular months or older, adolescents and adults against 2N polysaccharides from 23 pneumococcal serotypes measles, mumps and rubella. Use in infants 9-10 25mcg of each type in 0.5ml. 1 x 0.5ml, price Viral vaccine. Human rotavirus RIX4414 strain, not months under special circumstances (see SPC). available on request. less than 106 CCID50. Powder and solvent for oral V 0.5 ml by SC inj., can also be given IM. susp. 1, price available on request. S Active immunisation against For primary immunisation and/or revaccination S Active immunisation of infants from the pneumococcal disease. according to recommended schedules. age of 6 weeks for prevention of gastro-enteritis V Over 2 years, 0.5ml by SC or IM inj. D Acute severe febrile illness; due to rotavirus infection. D Less than 10 days prior to or during hypersensitivity to neomycin; impaired immune Q Infants (incl. preterm infants born after immunosuppressive therapy. Patients with responses (primary or secondary); pregnancy. 27 weeks of gestational age): 2 doses given orally: Hodgkinâ&#x20AC;&#x2122;s disease who have received extensive Avoid pregnancy within 3 months after 1st dose may be admin. from the age of 6 weeks. chemotherapy and/or nodal irradiation. Pregnancy, vaccination. Leave r4 weeks between doses. Course should lactation. B CNS disorder, susceptibility to febrile preferably be given before 16 weeks of age, and B Severely compromised cardiac and convulsions or family history of convulsions. completed by 24 weeks of age. It is recommended pulmonary function. Febrile respiratory illness or Supervision and treatment available in case of a active infection. Revaccination, See SPC.. rare anaphylactic event. May contain traces of egg that infants who receive a 1st dose of Rotarix complete the 2-dose regimen with Rotarix. A Local reactions, fever, relapse of protein: enhanced risk of immediate-type invasive disease caused by Neisseria meningitidis serogroup C. V Under 12 months: Two 0.5ml doses by IM inj. preferably in anterolateral thigh with at least 2 month interval between doses; 1st dose not earlier than 2 months of age; use different inj. sites. Booster dose recommended in infants, see SPC. Over 12 months: Single 0.5ml dose by deep IM inj. in deltoid region. Do not mix with other vaccines. D Acute severe febrile illness, hypersensitivity to diphtheria toxoid. B Pregnancy, lactation. Thrombocytopenia/coagulation disorders. Will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis/septicaemia. C Acellular pertussis components. Caution: 7-valent pneumococcal conjugate vaccine (Prevenar). A Inj. site reactions, fever. Infants: 1st-2nd year, anorexia, irritability, crying, drowsiness, impaired sleeping, GI disorders. Children: 3.5-6 years, irritability, headache, somnolence. Adults: Headache, somnolence, myalgia.
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IMMUNOLOGY
VACCINES
D Hypersensitivity after previous rotavirus vaccines. History of intussusception or uncorrected congenital malformation of GI tract that would predispose for intussusception. Postpone in subjects suffering from acute severe febrile illness, diarrhoea or vomiting. B Review medical history before use. Known or suspected immunodeficiency: Evaluate benefit vs risk. Caution: GI illnesses or growth retardation. Caution to individuals with immunodeficient close contacts. Contacts of recent vaccinees should observe personal hygiene. A protective immune response may not be elicited in all vaccinees. Does not protect against gastroenteritis due to other pathogens than rotavirus. Post-exposure prophylaxis, no data. Risk of apnoea in very premature infants. Contains sucrose and sorbitol. Must not be injected. C None known. A Irritability, loss of appetite, diarrhoea, vomiting, flatulence, abdominal pain, regurgitation of food, fever, fatigue.
STAMARIL
Sanofi Pasteur MSD
2N Live stabilised vaccine. Yellow fever vaccine (live). Powder for inj. after susp. with NaCl. Price available on request. S Active immunisation against yellow fever. V Under 9 months, not recommended; over 9 months, after reconstitution of vaccine, single dose should be given by deep SC inj. D Fever, acute disease, malignant conditions. Organ transplant recipients, immunosuppressive treatments, bone marrow transplant, impaired cell mediated immunity. Pregnancy, lactation. A Local reactions, fever, myalgia, rash, urticaria, lymphadenopathy, tiredness, asthenia, headache.
TETABULIN
Baxter
2N Tetanus immunoglobulin. Human tetanus Ig 250 IU per 1ml. Liquid in prefilled syringe. 1, A22.41. S Prophylaxis and and treatment of tetanus. V Prophylaxis, single dose of 250 IU IM inj. for passive immunisation. A second dose of 250 IU is recommended 3-4 weeks after first dose in patients with antibody defeciency or to protect against delayed tetanus.Treatment, usually 30006000 IU in combination with other clinical procedures. B Hypersensitivity reactions. Possibility of transmission of infectious agents. A Local pain and tenderness, fever, cutaneous reactions, nausea, vomiting, hypotension, tachycardia, allergies, anaphylactictype reactions.
TETRAVAC
Sanofi Pasteur MSD
2N Toxoid/inactivated vaccine. Diphtheria toxoid 30 IU, tetanus toxoid 40 IU, pertussis toxoid 25mcg, filamentous haemagglutinin 25mcg, inactivated poliovirus type 1, 2 and 3 80 units/0.5ml. Pre-filled single dose syringe. Price available on request. S Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis. P Not applicable. Q Primary immunisation can be given as 3 doses at intervals of 1-2 months starting at 2-3
AND IMMUNOGLOBULIN PRODUCTS
months of age, or as 2 doses at an interval of 2 months starting at 3 months of age and a third dose at 12 months of age. Booster, a fourth dose should be given within 2nd year. See SPC. D Fever, acute illness. Evolving encephalopathy. B Hypersensitivity, anaphylactic reaction. A Local reactions at inj. site, fever, irritability, drowsiness, sleep disturbances, diarrhoea, vomiting.
9.1
infection risk). Caution: Thrombocytopenia or bleeding disorders. A Local reactions, fever, malaise, general aches, headache, nausea, itching.
TYPHIM VI
Sanofi Pasteur MSD
2N
Inactivated surface antigen. Vi polysaccharide antigen of Salmonella typhi 25mcg/0.5ml. Liquid in pre-filled syringe. Price available on request. S Active immunisation against typhoid. TWINRIX ADULT GSK P 0.5ml by deep SC or IM inj. 2N Q Under 18 months, suboptimal response; asses risk of exposure. Over 18 months, same as Inactivated virus. Not less than 720 ELISA units of adult. inactivated hepatitis A virus and 20mcg of D Acute infections. recombinant HBsAg protein per 1ml dose. Susp. B Pregnancy, lactation. for inj. Price available on request. A Local reactions, fever, malaise, S Immunisation of non-immune adults headache. and adolescents (16 years and over) who are at risk of both hepatitis A and hepatitis B infections. VARITECT Intra Pharma P Primary vaccination consists of three doses: Initially 1ml dose followed by 1ml dose one 2 N month later and the third 1ml dose six months IV immunoglobulins. Human varicella-zoster Ig. Inj. after the first (0, 1 and 6 months). In exceptional Amps.-5ml, A231.00; 20ml, A938.20. circumstances the following schedule may be used: S Prevention of varicella for children 0, 7, 21 days followed by a booster at 12 months. under immunosuppressive treatment, neonates Q Not recommended. whose mothers contacted chicken pox within 5 2N days before birth or shortly afterwards. Children ALSO TWINRIX PAEDIATRIC Not less than 360 suffering from other infectious diseases during ELISA units of inactivated hepatitis A virus and suspected infection with chicken pox. Pregnant 10mcg of recombinant HBsAg protein per 0.5ml women after suspected infection with the dose. Susp. for inj. in prefilled syringe. Price pathogens of chicken pox/zoster who lack varicella available on request. antibodies. Treatment of zoster infections in highS Immunisation of non-immune infants, risk patients. Chicken pox prevention: 1ml/kg body children and adolescents (from 1 year up to and weight. Zoster infection treatment: 2ml/kg body incl. 15 years) who are at risk of both hepatitis A weight. See SPC. and hepatitis B infections. B Live vaccines. Q Primary vaccination consists of three C Live vaccines. doses: Initially 0.5ml dose followed by 0.5ml dose VARIVAX Sanofi Pasteur MSD one month later and the third 0.5ml dose six months after the first (0, 1 and 6 months). 2N D Acute severe febrile illness. Live attenuated virus. Live attenuated varicella B Not for post-exposure prophylaxis; not virus (Oka/Merck strain) r1350 PFU per 0.5ml. tested in patients with impaired immunity. Does Powder and solvent for suspension for inj. Price on not prevent infection caused by hepatitis C and request. hepatitis E or other pathogens known to infect S Vaccination against varicella from 12 the liver. Immune response to hepatitis B vaccines months of age. Prevention of infection in may be reduced by older age, male gender, susceptible individuals who have been exposed to obesity, smoking, admin. route, some chronic varicella within 3-5 days. Vaccination up to 5 days underlying diseases. Avoid intradermal injection or after exposure may modify course of infection. IM admin. into gluteal muscle. Exceptionally, SC P r 13 years: Two 0.5 ml doses 4-8 weeks admin. to subjects with thrombocytopenia or apart, by IM or SC inj. in deltoid region or higher bleeding disorders. Pregnancy, lactation (only if anterolateral region of thigh. benefits outweigh risks). R Over 65 years, no data. C Not to be given at the same time as Q 1-12 years: Two 0.5ml doses at least 1 other vaccines (Paediatric only). month apart; asymptomatic HIV infection (ageA Headache, GI disorders, injection site specific CD4+ T-lymphocyte r25%), two 0.5ml reactions injection site swelling/pain/redness, doses 12 weeks apart. fatigue. Paediatric only: Drowsiness, loss of D Blood dyscrasias, leukaemia, lymphomas, appetite, malaise, fever, irritability. or other malignant neoplasms affecting hemic and lymphatic systems. Immunosuppressive therapy, TYPHERIX GSK family history of/existing humoral or cellular 2N immunodeficiency, tuberculosis, fever q38,5oC. Inactivated surface antigen. Vi polysaccharide Pregnancy, lactation. antigen of Salmonella typhi (Ty2 strain) 25mcg/ B Use contraception for 3 months 0.5ml. Sln for inj. in prefilled syringe. 0.5ml-1; following vaccination. Avoid close association with price on request. susceptible high-risk individuals for up to 6 weeks following vaccination. S Active immunisation against typhoid. P 0.5ml by IM inj. at least 2 weeks prior to C Avoid salicylates for 6 weeks after vaccination. Defer vaccination for 5 months risk of exposure to typhoid fever. Q Under 2 years, not recommended; over following blood/plasma transfusions or admin. of normal human immune globulin or varicella zoster 2 years, as per adult. immune globulin (VZIG). D Severe febrile illness. A Fever, upper respiratory infection, B Pregnancy, lactation (only if high
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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9.2 IMMUNOLOGICAL
irritability, pruritus, rash, inj. site reactions.
VIATIM
Sanofi Pasteur MSD
2N Purified and inactivated vaccines. Combined purified Vi polysaccharide typhoid and inactivated hepatitis A vaccine. 1ml in dual chamber each containing 0.5ml vaccine which are mixed prior to admin. Price available on request. S Simultaneous active immunisation against typhoid fever and hepatitis A virus infection in subjects from 16 years of age. P 1ml admin. by slow IM inj. in deltoid region. May be admin. by SC route in patients with thrombocytopenia or at risk of haemorrhage. Protective levels may not be reached until 14 days after admin. Primary immunisation achieved with 1 single dose. Q Under 16 years, not recommended. D Acute severe febrile illness. Lactation (no data). B Hypersensitivity to neomycin. Pregnancy. A Pain, induration/oedema, eryhthema at inj. site, asthenia, headache, GI disorders, myalgia, arthralgia, malaise, fever, dizziness.
Astellas
2NT Macrolide immunosuppressant. Tacrolimus (monohydrate) 0.5mg, 1mg, 3mg, 5mg. Gelatin cap. containing white powder. Marked with strength on resp. light yellow, white, orange, greyish red caps and *647, *677, *637, *687 on orange body. 50, prices on request. S Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products. P See SPC. Q Not recommended. B Severe liver impairment. During initial post-transplant period, monitor BP, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly K+), liver / renal function, haematology, coagulation values, plasma proteins. EBV-associated lymphoproliferative disorders, ventricular hypertrophy reported (monitor high-risk patients). Limit exposure to sunlight / UV light. Discontinue if posterior reversible encephalopathy syndrome (PRES) occurs. Increased risk for opportunistic infections (incl. BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy (PML). Medication errors (incl. substitution of immediate- or prolongedrelease tacrolimus formulations) observed; alterations in formulation/regimen should only occur under supervision of transplant specialist. Contains lactose, soya lecithin. Avoid live attenuated vaccines. Pregnancy (if benefits outweighs risk). Do not breast-feed. See SPC. C Avoid St. Johnâ&#x20AC;&#x2122;s Wort, ciclosporin, grapefruit juice, K+ suppls., K+ sparing diuretics. Caution: CYP3A4 inhibitors/ inducers/ substrates (see Appendix I; adjust dose to maintain
PRICES Prices are included as a guide to relative cost and should not be regarded as having any direct relationship with retail prices.
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tacrolimus levels), nephrotoxic/ neurotoxic drugs (aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir, aciclovir), oral contraceptives, plasma protein bound drugs (eg oral anticoagulants, oral antidiabetics). A Headache, tremor, GI disorders, renal impairment, diabetes, hyperglycaemia, hyperkalaemia, hypertension, abnormal liver function tests, insomnia. Ischaemic coronary artery disorders, tachycardia, tinnitus, arthralgia, muscle cramps, pain in limb/ back, eye and respiratory disorders, rash, acne, pruritus, alopecia, increased sweating, seizures, disturbances in consciousness, paraesthesias, dysaesthesias, peripheral neuropathies, dizziness, blood dyscrasias, primary graft dysfunction, febrile disorders, pain, discomfort, asthenia, oedema, disturbed body temperature perception, increased blood AP, increased weight. See SPC.
CELLCEPT
Roche
2MT Immunosuppressant. Mycophenolate mofetil 250mg. Blue/brown cap. marked with name, strength and logo. 100, A151.05.
2MT
9.2 IMMUNOLOGICAL DRUGS
ADVAGRAF
IMMUNOLOGY
DRUGS
ALSO CELLCEPT SUSPENSION Mycophenolate mofetil 1g per 5ml. Susp. 110g, A242.03.
2MT ALSO CELLCEPT TABLETS Mycophenolate mofetil 500mg. Lavender cap.-shaped tab. marked name, strength and logo. 50, A151.05. S Prophylaxis of acute allogeneic renal, cardiac or hepatic transplant rejection when used in combination with cyclosporin and corticosteroids. P Renal: 1g twice daily, initiated within 72 hours of transplantation. Cardiac:1.5g twice daily; initiated within 5 days following transplantation. Hepatic: 1.5g twice daily as soon as tolerated following 4 days of IV therapy. Q Renal: For children with body surface area q1.5m2, 600mg/m2 twice daily, max 2g daily. Not recommended for cardiac or hepatic transplantation.
2NT ALSO CELLCEPT INFUSION Mycophenolate mofetil (HCl) 500mg. Powder in vial. 4, A62.42. S In combination with cyclosporin and corticosteroids for the prophylaxis of acute rejection in allogeneic renal or hepatic transplant. P Reconstitute powder and dilute to a concentration of 6mg/ml. Renal: admin. 1g twice daily by slow IV inf. over 2 hours via a peripheral or central vein starting within 24 hours of the transplant and continue up to 14 days. Transfer to oral therapy as soon as tolerated. Hepatic: 1g twice daily for first 4 days following transplant changing to oral as soon as tolerated. Q Not recommended. D Pregnancy, lactation. Use of live attenuated vaccines. B Monitor full blood counts weekly for first month, fortnightly for next two months and monthly thereafter. GI disease. Reduce exposure to sunlight and UV rays. Elderly. C Acyclovir, antacids, azathioprine, cholestyramine, probenecid. A GI upset, blood dyscrasias, sepsis, infections, hypertension, metabolic and CNS disturbances, respiratory disorders.
IMUGER 2NO
Cytotoxic immunosuppressant. Azathioprine 25mg, 50mg. Pale yellow tabs marked AE 25, AE50 on one side. 25mg-100, A29.51; 50mg-100, A42.96. S In combination with other immunosuppressants for prophylaxis of allogenic transplant rejection, autoimmune diseases that are unresponsive or cannot be prescribed steroids e.g. rheumatoid arthritis, SLE, Crohnâ&#x20AC;&#x2122;s disease. P Transplant: Loading dose up to 5mg/kg daily; maintenance 1-4mg/kg daily. Other conditions 1-3mg/kg daily. D Severly renal, hepatic or bone marrow impairment, pancreatitis, severe infections, lactation. B Pregnancy. C Allopurinol, muscle relaxants, cyclosporin or tacrolimus, olsalazine and analogues, warfarin. A Myelosuppression, hepatotoxicity, GI upset, rash.
IMURAN
Aspen
2NO Cytotoxic immunosuppressant. Azathioprine 25mg, 50mg. Round, biconvex, film-ctd tabs. 25mg: Orange marked GXEL5. 50mg: Yellow marked GXCH1. 25mg-100, A17.71; 50mg-100, A26.95.
2JNO ALSO IMURAN INJECTION Azathioprine (Na+ salt) 50mg. Powder in vial. 1, A19.08. S Transplantations; certain auto-immune diseases. V Transplant: Loading dose up to 5mg/kg daily; maintenance 1-4mg/kg daily. Other conditions 1-3mg/kg daily. B Monitor for toxic effects, especially blood counts. Infection. Impaired renal/hepatic function. Pregnancy. Undue sun exposure. C Allopurinol, oxipurinol, thiopurinol, muscle relaxants, warfarin, cytostatics, aminosalicylate derivatives. Live vaccines (contra). A Myelosuppression, hepatotoxicity, GI distress, rashes.
MYFORTIC
Novartis
2MT
Immunosuppressant. Mycophenolic acid (as mycophenolate Na+) 180mg, 360mg. Lime green, round tab. marked C and pale orange ovaloid tab. marked CT resp. Both film-ctd. 180mg-120, 360mg120; price available on request. S In combination with cyclosporin and corticosteroids for the prophylaxis of acute transplant rejection in adult patients receiving allogeneic renal transplants. P 720mg twice daily with or without food (adhere to selected option). De-novo patients, initiate treatment within 72 hours following transplantation. Tab. should not be crushed. Q Children and adolescents, not recommended. D Pregnancy, lactation. B Increased risk of lymphomas and other malignancies; limit exposure to sun and UV. Monitor for neutropenia; complete blood counts weekly during 1st month, twice monthly for 2nd and 3rd months, then monthly through 1st year. Severe renal impairment, serious digestive system disease. Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT); avoid. Contains lactose. C Live attenuated vaccines, azathioprine Gerard (not recommended). Caution: Aciclovir or ganciclovir, Mg-Al containing antacids, drugs that
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
IMMUNOLOGY
IMMUNOLOGICAL
bioequivalent to Sandimmun; specify brand when prescribing. C Systemic antibiotics, live vaccines, phenytoin, ketoconazole, fluconazole, itraconazole, erythromycin, rifampicin, carbamazepine, barbiturates, Ca++ antagonists, HMG-CoA reductase inhibitors, colchicine, NEORAL Novartis nephrotoxic drugs, oral contraceptives, propafenone, prednisolone, methylprednisolone, 2MT K+suppl., K+sparing diuretics, lipid solutions, Fungal metabolite immunosuppressant. NSAIDs, doxycycline, sulphadiazine, IV Cyclosporin 25mg blue-grey oval cap., 50mg sulphadimidine, IV trimethoprim, diclofenac, yellow-white oblong cap.; 100mg blue-grey nifedipine, grapefruit juice. oblong cap. All marked with S in a triangle and A Renal and hepatic dysfunction, cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; hypertension, tremor, GI disturbances, 100mg-30, A96.03. hypertrichosis, gingival hypertrophy, malignancies, 2MT lymphoproliferative disorders, burning sensations (feet and hands), fatigue, muscle weakness or ALSO NEORAL ORAL SOLUTION Cyclosporin cramp, myopathy. Rarely hyperkalaemia, 100mg/ml. Oral soln. 50ml, A143.89. S Immunosuppression in organ and bone hyperuricaemia, hypomagnesaemia, hypercholesterolaemia, oedema, convulsions, marrow transplantation; prophylaxis and headache, rash, mild anaemia, haemolytic uraemic treatment of graft-versus-host disease. syndrome, weight gain, pancreatitis, colitis, V See lit. paraesthesia, neuropathy, confusion, B Only use under specialist supervision. dysmenorrhoea, amenorrhoea, gynaecomastia, Closely monitor renal and liver function, BP and encephalopathy. serum lipids, serum K+. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. Not bind bile acids (eg. colestyramine, oral activated charcoal). A Opportunistic infections, leukopenia, anaemia, thrombocytopenia, headache, cough, GI disorders, fatigue, pyrexia, abnormal hepatic function tests, increased blood creatinine.
PRESCRIBING NOTES IMMUNOSUPPRESSANTS Immunosuppressants are used to suppress the rejection of transplanted organs, but are also useful in the treatment of a range of other inflammatory and auto-immune states. Azathioprine is widely used in transplantation, and for a range of auto-immune conditions. It is cytotoxic, and inhibits DNA synthesis, preventing the multiplication of lymphocytes that are induced by the introduction of a new allergen into the body, as occurs in transplantation. Its actions are non-specific. Side effects include myelosuppression, mainly leucopenia and thrombocytopenia. Mycophenolic acid (as mycophenolate mofetil or mycophenolate sodium) is more specific in its action. It is used prophylactically as a treatment for acute allogeneic renal transplant rejection, usually in combination with cyclosporin and corticosteroids. Cyclosporin is also more specific in action than azathioprine, It inhibits lymphocyte replication and the production of interleukin 2. It has fewer side effects on bone marrow but is significantly nephrotoxic, so kidney function should be monitored. The absorption of cyclosporin is dependant on the presence of bile in the gut and as the brands vary in their bioavailability, the brand must be specified when prescribing. Tacromilus is a macrolide lactone immunosuppressant, used as a first line treatment or in those patients resistant to other immunosuppressive regimens. It has a similar mode of action to cyclosporin and similar side effects. It also has cardiac effects and can cause cardiomyopathy, it is recommended that those patients receiving the drug should be monitored carefully by echocardiography. References available on request. Revised November 04
DRUGS
9.2
2NT Immunosuppressant. Sirolimus 1mg, 2mg. White and yellow triangular ctd tabs. marked RAPAMUNE and strength. 30. Price available on request.
2NT
ALSO RAPAMUNE ORAL SOLUTION Sirolimus 1mg/ml. 60ml. Price available on request. S Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. Initially in combination with cyclosporin microemulsion and corticosteriods for 2-3 months. Continue as maintenance therapy with corticosteroids only if cyclosporin can be progressively discontinued. P Initial dose of 6mg at time of transplant, followed by 2mg once daily. Dose should be individualised to obtain blood levels of 4-12ng/ml. Continue therapy for 2-3 months. Maintenance: Discontinue cyclosporin progressively over 4-8 weeks and adjust Rapamune dose to give blood levels of 12-20ng/ml given with corticosteriods. See SPC. Severe hepatic impairment, reduce maintenance dose by half; monitor every 5 to 7 days until 3 consecutive trough levels show stable concentrations of sirolimus. PROGRAF Astellas Q Under 18 years, not recommended. 2NT D Pregnancy, lactation. Use effective Macrolide lactone immunosuppressant. Tacrolimus contraception during therapy and for 12 weeks 0.5mg, 1mg, 5mg. Light yellow, white, grey-red after use. cap. marked with strength and 607, 617 and B Hepatic impairment. Increased 657 resp. 50, prices on request. susceptibility to infections; development of 2NT lymphoma and other malignancies, particularly of the skin, exposure to sun and UV light; new onset ALSO PROGRAF CONCENTRATE FOR INFUSION nephrosis. Antimicrobial prophylaxis for Tacrolimus 5mg/ml. Conc. soln. in amp. 10, price Pneumocystis carinii pneumonia, admin. for 12 on request. S Immunosuppression in liver, kidney and months; cytomegalovirus (CMV) prophylaxis, admin. for 3 months. Monitor for hyperlipidemia, heart allograft recipients. Treatment of allograft initate therapy if necessary. Monitor urinary rejection resistant to other immunosuppressive protein excretion periodically. Reports of fluid regimens. accumulation and hypersensitivity reactions. Severe V See SPC. hepatic impairment: After a loading dose or a D Hypersensitivity to polyoxyethylene change of dose, perform therapeutic drug hydrogenated castor oil (IV only). monitoring for a prolonged period of time until B Severe liver impairment. During initial stable concentrations are reached. Contain sucrose post-transplant period, monitor BP, ECG, and lactose. neurological and visual status, fasting blood C Not recommended: Strong inhibitors of glucose levels, electrolytes (particularly K+), liver CYP3A4 (e.g. ketoconazole, voriconazole) or and renal function, haematology, coagulation inducers of CYP3A4 (e.g. rifampicin, rifabutin), values, plasma proteins. EBV-associated ciclosporin, mycophenolate mofetil and lymphoproliferative disorders, ventricular hypertrophy reported (monitor high-risk patients). corticosteroids combined with Il-2 receptor Limit exposure to sunlight and UV light. Contains antibody induction. Caution: Other inducers/ lactose. Pregnancy (if benefits outweighs risk). Do inhibitors of CYP3A4, cisapride, metoclopramide, oral contraceptives, calcineurin inhibitors. not breast-feed. A UTI, sepsis, pneumonia, pyelonephritis, C Avoid grapefruit juice, St John’s wort, herpes simplex, fungal, viral, and bacterial live vaccines, K+ suppls., K+ sparing diuretics, ciclosporin. Caution: CYP3A4 substrates/ inhibitors/ infections, skin cancer, thrombocytopenia, inducers (eg macrolide antibiotics, see Appendix I), anaemia, thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome, leukopenia, nephrotoxic/neurotoxic drugs (aminoglycosides, neutropenia, abnormal liver function tests, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir, aciclovir), oral contraceptives, hypokalaemia, hypophosphataemia, hypercholesterolaemia, hyperglycaemia, plasma protein bound drugs (eg oral hypertriglyceridaemia, tachycardia, lymphocele, anticoagulants, oral antidiabetics). DVT, pneumonitis, epistaxis, abdominal pain, A GI disorders, renal impairment, hyperglycaemia, diabetes mellitus, hyperkalaemia, diarrhoea, stomatitis, acne, rash, arthralgia, insomnia, tremor, headache, seizures, disturbances osteonecrosis, proteinuria, peripheral oedema, impaired healing, oedema, pyrexia, blood lactate in consciousness, paraesthesias and dysaesthesias, dehydrogenase increased, AST/ALT increased. peripheral neuropathies, dizziness, ischaemic coronary artery disorders, tachycardia, tinnitus, SANDIMMUN Novartis vision blurred, rash, arthralgia, muscle cramps, pain in limb/ back. See SPC. 2MT Fungal metabolite immunosuppressant. RAPAMUNE Wyeth Cyclosporin 25mg pale pink oval cap., 50mg
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
235
10.1 TONICS
DIETETICS
AND BITTERS
yellow oblong cap.; 100mg dusky pink oblong cap. tract infection, viral infection, sepsis and constipation (in children). 25mg-30, A29.01; 50mg-30, A53.77; 100mg-30, A105.50.
2NT
THYMOGLOBULINE
ALSO SANDIMMUN ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A129.09.
2N
Genzyme
Immunoglobulin. Rabbit anti-human thymocyte 2NT immunoglobulin 25mg (5mg/ml in reconstituted ALSO SANDIMMUN IV INFUSION Cyclosporin sln). Powder for sln for inf. in vial. 1. Price on 50mg/ml; amps. 10 x 1ml, A25.36. request. S Immunosuppression in organ and bone S Immunosuppression in solid organ marrow transplantation; prophylaxis and transplantation, in conjunction with other treatment of graft-versus-host disease. immunosuppressive drugs: Prevention of graft V See lit. rejection in renal or heart transplantation; D Hypersensitivity to cyclosporin or to treatment of steroid resistant graft rejection in polyethoxylated castor oils (IV only). renal transplantation. B Monitor renal and liver function, BP and P Graft rejection prophylaxis: 1-1.5mg/kg/ serum lipids. Hyperkalaemia, hyperuricaemia. day for 3-9 days after kidney transplantation. 1Pregnancy, lactation. 2.5mg/kg/day for 3-5 days after heart C Systemic antibiotics, live vaccines, transplantation. Steroid resistant graft rejection: phenytoin, ketoconazole, fluconazole, 1.5mg/kg/day for 7-14 days after kidney itraconazole, erythromycin, rifampicin, transplantation. Obese patients, base dosing on carbamazepine, barbiturates, Ca++ antagonists, ideal weight rather than actual weight. See SPC. HMG-CoA reductase inhibitors, colchicine, Q As per adults; no data for graft rejection in renal transplantation. nephrotoxic drugs, oral contraceptives, D Hypersensitivity to rabbit proteins. propafenone, prednisolone, methylprednisolone, Active acute or chronic infections. Lactation. K+suppl., K+sparing diuretics, lipid solutions, B Serious immune-mediated reactions NSAIDs. A Anaphylactoid reactions may occur with (anaphylaxis, severe cytokine release syndrome) infusion. Renal and hepatic dysfunction, tremor, GI may occur rarely. May occur: Infections, disturbances, hypertrichosis, gingival hypertrophy, reactivation of infection, sepsis, injection site reactions. Monitor blood cell and platelet count burning sensations (feet and hands), fatigue, during and after treatment. May increase muscle weakness or cramp, myopathy, malignancies, lymphoproliferative disorders. Rarely incidence of malignancies, lymphoma or posttransplant lymphoproliferative disease. hyperkalaemia, hyperuricaemia, Immunisation with live attenuated vaccines not hypomagnesaemia, oedema, convulsions, headache, rash, mild anaemia, haemolytic uraemic recommended. Pregnancy (only use if clearly needed). Driving/operating machines. syndrome, weight gain, pancreatitis, colitis, C May interfere with ELISA tests. paraesthesia, neuropathy, confusion, A Lymphopenia, neutropenia, dysmenorrhoea, amenorrhoea, gynaecomastia, thrombocytopenia, GI disorders, fever, shivering, encephalopathy. serum sickness, infection, myalgia, malignancy, SIMULECT Novartis dyspnoea, prutitus, rash, hypotension.
2N Chimeric (murine/human) monoclonal antibody immunosuppressant. Basiliximab 20mg. Vial Price available on request. S Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients with panel reactive antibodies less than 80%. To be used as part of a dual or triple immunosuppressive regimen that includes cyclosporin microemulsion formulation and corticosteroids. V See lit. D Pregnancy, lactation. B Only use under specialist supervision. Medications for the treatment of severe hypersensitivity reactions should be available for immediate use following administration. C Basiliximab is an immunoglobin, no metabolic drug-drug interactions are to be expected. However, no formal interaction studies have been conducted. A There appears to be no increase in the incidence of serious adverse effects when compared to placebo. The most commomly reported events in both treatment groups are constipation, UTI, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyerkalaemia, hypercholesterolaemia, surgical wound complication, weight increase, increased serum creatinine, hypophosphataemia, diarrhoea and upper RTI (in adults), UTIs, hypertrichosis, rhinitis, fever, hypertension, upper respiratory
236
especially in the aged. P 10ml three times daily before meals. Q t-v adult dose.
METATONE
Chefaro
2 Tonic. Thiamine (HCl) 0.5mg, Ca++ glycerophos. 45.6mg, manganese 5.7mg, K+ 45.6mg, Na+ 22.8mg per 5ml. Liquid. 300ml, A5.15. S General tonic. P 5-10ml two or three times daily. Q Under 6 years, not recommended; 6-12 years, half adult dose.
10.2 ANAEMIAS
COSMOFER
Vitaline
2NO
Haematinic. 50mg/ml iron (III) (hydroxide dextran complex). 2ml amps. containing soln. for inf./inj. 2ml-5 amps, A54.94. S Iron deficiency where there is an intolerance/lack of effect of oral iron preparations. Need to deliver iron rapidly to iron stores. P 100-200mg iron (2-4 ml), 2-3 times per week (depending on Hb levels). Rapid delivery of iron to body iron stores: Admin. total dose inf. up to total replacement dose (20mg iron/kg body weight). Admin. IV drip inf. or slow IV inj. or as undiluted soln. IM. Q Under 14 years, not recommended. D Non-iron deficiency anaemia, iron overload/utilisation disturbances. Iron mono/ disaccharide complexes, dextran hypersensitivity. Decompensated liver cirrhosis, hepatitis, acute/ chronic infection, rheumatoid arthritis, acute renal failure. Pregnancy (1st trimester), lactation. B History of allergy (monitor); ensure anaphylactic emergency measures available. Immune (auto) disorder, inflammatory conditions (e.g. SLE, RA). History of asthma, allergic disorders, inflammatory disorders (use IM route). C Co-admin. with other IV iron10.1 TONICS AND BITTERS carbohydrate complexes A Dyspnoea, GI disturbances, flushing, EFFICO Ocean pruritus, rash, blurred vision, feeling hot, cramps, numbness, local inj. site reactions. Hypotension (IV 2 Tonic. Thiamine (HCl) 0.18mg, nicotinamide 2.1mg, given too rapidly). caffeine 20.2mg per 5ml. Syrup. 300ml, A3.29. FEFOL SPANSULE Intrapharm Labs. S As an adjunct during convalescence,
2
PRESCRIBING NOTES TONICS AND BITTERS Tonics are used to stimulate appetite in those individuals who are finding it difficult to maintain an interest in food. They mostly contain simple and aromatic bitters. Their efficacy depend heavily on suggestion. Caffeine and related sympathomimetic amines exert a central stimulant effect which helps produce a feeling of well being and can thus lead to an increase in appetite. Vitamin B and related complexes are often included in a number of tonics. It is more usual to use vitamins to treat a specific deficiency, but in this case they may also be contributing to a feeling of well being and possibly an increased interest in food. The use of glycerophosphates of calcium and manganese is based on the theory that these salts are more easily absorbed by the body especially the brain and can be of use in patients who have not eaten for some time. References available on request.
Haematinic. Ferrous sulphate 150mg (equiv. 47mg Fe), folic acid 0.5mg. Green/clear sust.-release cap. with red, yellow and white pellets. 30, A2.10. S Prophylaxis of iron and folic acid deficiencies in 2nd and 3rd trimesters of pregnancy. P 1 daily. Q Not applicable. D Active peptic ulcer, regional enteritis, ulcerative colitis, vit. B12 deficiency, paroxysmal nocturnal Hburia, haemosiderosis, haemochromatosis, repeated blood transfusion. B First trimester. History of peptic ulcer, folate dependent tumours. C Tetracyclines, antacids, co-trimaxoazole, anticonvulsants, penicillamine, chloramphenicol, sulphasalazine, cholestyramine. A GI upset, allergic reactions.
FEOSPAN SPANSULE
Intrapharm Labs.
2 Haematinic. Ferrous sulph. 150mg (equiv. 47mg Fe). Clear/red sust.-release cap. with green and red
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS
ELECTROLYTES, FLUIDS
pellets. 30, A1.88. S Iron deficiency anaemias. P 1-2 daily. Q Under 1 year, not recommended; 2-12 years, 1 daily under direction of physician. D Undiagnosed anaemia. B Haemochromatosis, haemolytic anaemia. Prolonged or execessive use in children, 1st trimester of pregnancy. C Tetracyclines, antacids. A Mild GI upset.
FER-IN-SOL 2O
pregnancy after 13 weeks. P 1 daily before food. Q Not recommended.
10.3 ELECTROLYTES, FLUIDS AND
2
ADDIPHOS
Teofarma
2O Haematinic. Ferrous sulf. 325mg (equiv. 105mg Fe). Red sust.-release film-ctd tab. marked with maker’s symbol. 30, A1.66, 150, A7.06. S Iron deficiency anaemia. May be used in PRESCRIBING NOTES ANAEMIAS IRON: Oral iron preparations can be given as either the ferrous or ferric salts. The ferrous salts are better absorbed and the type of salt chosen is not clinically important but usually based on incidence of side effects and costs. Ferrous sulphate (100mg of ferrous sulphate equivalent to 32.5mg of elemental iron) is most commonly used. Side effects of treatment include a range of GI disturbances and consequently treatment should be avoided in patients with GI obstruction or ulceration. Side effects can be controlled by utilising sustained-release preparations, slowly increasing the dose over time and taking the preparations after food. Changing the salt used can also reduce side effects but may be due to a decrease in the amount of elemental iron being administered with the new preparation. Patients should also be warned that iron supplements can also lead to constipation and/or diarrhoea and discolour stools. The absorption of iron preparations is decreased by concurrent administration of antacids and tetracyclines. FOLIC ACID: Compound preparations of iron and folic acid are used during pregnancy to correct deficiencies that may occur in the mother. Folic acid used on its own can be utilised in those women planning a pregnancy or those who are just pregnant to reduce the risk of neural tube defects in the foetus. It is recommended that those planning pregnancy should take 400mcg of folic acid daily until the twelfth week of pregnancy, those already pregnant should commence and also continue until the twelfth week. If there is history of neural tube defects in the family or there has been a previous effected pregnancy then the dose should follow the same schedule but be increased to 4mg daily. References available on request.
ALSO FERROGRAD C Ferrous sulf. 325mg (equiv. 105mg Fe), ascorbic acid 500mg. Red sust.-release film-ctd oblong tab. 30, A4.05, 150, A20.25. S Iron deficiency anaemia, especially where absorption is a problem. P 1 daily before food. Q Not recommended.
Fresenius Kabi
2N Phosphate suppl. K+ (phos.) 170.1mg, Na+ (phos.) 133.5mg, potassium (hydrox.) 14mg, sorbitol 1mg per ml (providing 2mmol phosphate, 1.5mmol potassium, 1.5mmol sodium per ml). Soln. in vial. 10 x 20ml, A16.05.
2O
ADDITRACE
(equiv. 105mg Fe), folic acid 350mcg. Two-layer red/yellow sust.-release film-ctd tab. marked with maker’s symbol. 30, A1.71; 150, A7.27. S Anaemia of pregnancy after 13 weeks. P 1 daily before food. Q Not applicable. D Diverticular disease, intestinal obstruction, haemochromatosis and iron overload syndromes, sensitivity to some sugars. Vit. B12 deficiency (Ferrograd Folic). B Delayed intestinal transit. C Antacids, tetracyclines, captopril. Clinistix urine test (Ferrograd C).
2N
FERRUM
10.3
PARENTERAL NUTRITION
BMS ALSO FERROGRAD FOLIC Ferrous sulf. 325mg
Haematinic. Ferrous sulph. 125mg/ml. Drops. 30ml, A4.02. S Prevention and treatment of iron deficiency anaemia in infants and children. Q 4 weeks-6 years, 0.3ml. Over 6 years and adults, 0.6ml.
FERROGRAD
AND PARENTERAL NUTRITION
Fresenius Kabi
Trace elements. Trace elements for addition to adult vit. solns. 20 x 10ml, A48.86.
CALCICHEW D3 FORTE
Shire
2O
Calcium/vit. D suppl. Ca++ carb. 1.25g (equiv. Ca++ 500mg), vit. D3 400 IU. White chewable tab. 100, A12.31. S Vit. D/calcium deficiency in elderly, adjunct in osteoporosis, pregnancy, vit. D dependent osteomalacia. P 2 daily preferably 1 morning and evening. Hausmann Q Under 12 years, not recommended.
2
2O
ALSO CALCICHEW Ca++ carb. 1.25g (equiv. Ca++ 500mg). White chewable tab. 100, A13.49. S Calcium deficiency states in osteoporosis, osteomalacia, rickets, tetany, malabsorption states, pregnancy and lactation. May be used as phosphate binding agent in renal failure in patients on renal dialysis. 2 P 2-6 daily. ALSO FERRUM SYRUP Iron hydroxide polymaltose Q Half adult dose. (equiv. 50mg Fe) per 5ml. 150ml, A3.63. D Hypercalcaemia, hypercalciuria. P 100-200mg (10-20ml) iron daily. C Tetracyclines, fluoride, iron, cardiac Q 1-12 years, 50-100mg (5-10ml) iron daily; glycosides, thiazide diuretics. over 12 years, same as adult. A Mild GI disturbance, hypercalcaemia. D Iron storage or assimilation disease. B Antacids. CALTRATE Wyeth Healthcare C Antacids. 2OY A GI upset. Calcium/vit. D suppl. Ca++ (as carbonate) 600mg, GALFER Thornton & Ross cholecalciferol 10mcg (eq. to 400 I.U. vit. D3). Cap.shaped grey/beige tab. scored on 1 side and 2O engraved with D 600 on each side of score. Other Haematinic. Ferrous fumarate 305mg. Red/green side is engraved with Caltrate. 90, A7.84. cap. marked GALFER. 28, A1.43. S Correction of combined vit. D and Ca++ S Prevention and treatment of iron deficiencies in the elderly. Supply of vit. D and deficiency states. Ca++ as adjunct to specific treatments for P Prophylaxis: 1 daily. Treatment: 1 twice osteoporosis, in patients with diagnosed or at daily. high risk of combined vit. D and Ca++ deficiencies. Q Not recommended P 1 tab. twice a day with a large glass of 2O water. Pregnant women: 1 tab. a day. ALSO GALFER SYRUP Ferrous fumarate 140mg/ Q Not recommended. 5ml. 100ml, A3.12. D Renal failure. Hypercalciuria and S Iron-deficiency anaemia. hypercalcaemia and diseases / conditions leading P 1 cap. or 10ml once or twice daily to hypercalcaemia and/or hypercalciuria (e.g. before meals. myeloma, bone metastases, primary Q Infants and young, 2.5-5ml once or hyperparathyroidism). Kidney stones twice daily. (nephrolitiasis, nephrocalcinosis). Hypervitaminosis 2O D. Soya/peanut hypersensitivity. ALSO GALFER FA Ferrous fumarate 305mg, folic B Caution: Prolonged treatment, acid 350mcg. Red/yellow cap. marked GALFER F.A. immobilised patients, sarcoidosis, decreased renal 28, A1.49. function. Reduce or interrupt treatment S Prophylaxis of iron and folic acid temporarily if urine Ca++ q 7.5mmol/24h (300mg/ 24h). Pregnancy, lactation. Contains sucrose. deficiencies in pregnancy. C Caution: Thiazide diuretics, systemic P 1 daily before meals. corticosteroids, orlistat, combined ion-exchange Q Not applicable. resin, paraffin, cardiac glycosides, phenytoin, C Tetracyclines. barbiturates. Absorption may be reduced by A Nausea, constipation. Haematinic. Iron hydroxide polymaltose (equiv.100mg Fe). Brown/white mottled chewable tab. 30, A4.11. S Iron-deficiency anaemia. P 1-3 daily. Q Not recommended.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
237
10.3 ELECTROLYTES,
reconstitute 1 sachet after every loose motion. Infants: 1 to 1v times the usual feed vol or 150ml/ kg daily. Infants under 12 months: Only under medical advice. B Only reconstitute with water at volume CALVIDIN Ergha stated. Severe renal/hepatic impairment or other conditions where normal electrolyte balance is 2OY distributed. If nausea and vomiting present, drink Calcium/vit. D suppl. Ca++ carb. 1500mg (equiv. small but frequent amounts at first. If no Ca++ 600mg), cholecalciferol 4mg (equiv. vit. D3 improvement within 24-36 hr consult physician. 10mcg/400 IU). White chewable scored tab. marked C/D. 60, A8.51. DIPEPTIVEN Fresenius Kabi S Correction of combined vit. D and 2J calcium deficiency in elderly, adjunct to specific treatment for osteoporosis. Parenteral nutritional. N(2)-L-alanyl-L-glutamine P 1-2 daily. 200mg/ml Concentrate for soln for inf. 50ml, A41.90; 100ml, A71.74. Q Not recommended. D Hypercalcaemia, hypercalciuria. S Intravenous parenteral nutrition C Tetracycline, fluoride, iron, cardiac regimen as a supplement to amino acid solutions glycosides, thiazide diuretics. or an amino acid containing inf. regimen, e.g. in A Mild GI disturbances, hypercalcaemia. patients in hypercatabolic and/or hypermetabolic states. DECAL Ricesteele P 1.5 - 2.0ml/kg body weight by central venous inf. Max. daily dose: 2.0ml/kg body weight. 2K Calcium/vit. D suppl. Ca++ lactate 235mg, calcium Inf. rate R 0.1g amino acids/kg body weight per hour. Duration: Max. 3 weeks. gluconate 100mg, calcium phosphate 235mg D Severe renal/hepatic insufficiency, severe (providing calcium 120mg), vit. D2 50 IU. White metabolic acidosis. tab. scored one side. 50, A1.52. B Hepatic insufficiency. Pregnancy, S Calcium and vitamin D supplement. lactation. Control serum electrolytes, serum P 1-6 daily. osmolarity, water balance, acid-base status, liver Q 1-3 daily. function tests, possible symptoms of B History of renal stones. hyperammonaemia. Monitor the enzymes alkaline DIORALYTE sanofi-aventis phosphatase, GPT, GOT, bilirubin level and the acid-base status. The choice of a peripheral or 2O central vein depends on the final osmolarity of Electrolytes. Sodium Cl 0.47g, K+ Cl 0.30g, mixture. Experience q 9 days is limited. disodium hydrogen citrate 0.53g, glucose 3.5g. Powder in sachet (plain, flavoured). 20, A4.68. ELECTROLADE Eastern S Oral correction of fluid and electrolyte 2 loss and management of watery diarrhoea. Electrolytes. Sodium chlor. 236mg, K+ chlor. P 20-40ml/kg daily. (Approx. 1-2 sachets 300mg, Na+ bicarb. 500mg, glucose 4g. Powder after every loose motion). Reconstitute 1 sachet (flavoured) in sachets. 6, A1.39; 20, A4.43. with 200ml fresh drinking water. Q Children: As per adults except S Replacement of fluid and electrolyte Caltrate: Tetracycline, iron, zinc, strontium, estramustin, thyroid hormones, bisphosphonate, sodium fluoride, fluoroquinolone. Foods rich in oxalic or phytic acid may inhibit absorption.
PRESCRIBING NOTES ELECTROLYTES: General electrolyte deficiency can arise due to excessive vomiting and/or or diarrhoea as occurs in gastro-enteritis, food poisoning, and infections. Especially vulnerable are the young or elderly. A variety of flavoured electrolyte solutions are available, which are useful for those who can still take fluid orally; parenteral treatment is required for those who are not. Specific electrolyte deficiencies can be treated with a range of supplements. CALCIUM: Supplementation is required when dietary intake is insufficient. Calcium requirements vary with age being greatest in the growing years, during pregnancy and lactation; deficiency in the elderly is usually due to poor absorption. Calcium supplementation can also be used to help prevent bone loss in post-menopausal women who have a dietary intake lower than the RDA. Calcium preparations can cause GI irritation and should be used with caution in patients with any degree of GI obstruction or ulceration. FLUORIDE: Supplementation can be considered for children who live in areas where there is no artificial fluoride supplementation. It is now thought that direct application of fluoride to the enamel confers the best protection against dental caries. No supplementation should be given if local water contains more than 0.7ppm fluoride (700mcg per litre). POTASSIUM: Supplementation is indicated when dietary intake is low or in patients who suffer potassium loss as a result of drug treatment. Correction is especially required in patients taking digoxin or antiarrhythmic drugs, with secondary hyperaldosteronism and with excessive losses of potassium in body fluids. All supplementation should be monitored carefully and especially in patients who have any degree of renal insufficiency as this could lead to a dangerous hyperkalaemic condition, or those on ACE inhibitor treatment. Hyperklaemic states can be treated using ion exchange resins such as calcium resonium. MAGNESIUM: Magnesium is a constituent of many enzyme systems especially those associated with energy. Magnesium is secreted in large amounts from the gut and consequently magnesium salts are not well absorbed. Hypomagnesaemia can be caused by losses in diarrhoea, stoma or fistulas, alcoholism and diuretic therapy. It can lead to deficiencies in calcium, potassium and sodium. References available on request.
238
DIETETICS
FLUIDS AND PARENTERAL NUTRITION
loss. P 1-2 sachets after every loose motion, max. 16 in 24 hours. Reconstitute 1 sachet in 200ml water. Q Under 2 years, 1-1v times normal feed volume; over 2 years, 1 sachet after every loose motion, max. 12 in 24 hours. D Renal impairment.
IDEOS
Helsinn Birex
2Y Calcium/vit. D suppl. Ca++ carbonate 1.25g (equiv. Ca++ 500mg), vit. D3 400 IU. Lemon flavoured white square chewable tab. 60, A8.61. S Calcium/vit. D deficiency in elderly, adjunct in osteoporosis. P 1 twice a day. Q Not recommended. D Hypercalcaemia, hypercalciuria, Ca++ lithiasis, tissue calcification. Prolonged immobilisation. Vit. D overdose, myeloma and bone metastases, renal insufficiency. B Mild to moderate renal failure. C Tetracyclines, vit. D, etidronate, cardiac glycosides, fluoride, thiazide diuretics. A Hypercalciuria, hypophosphataemia, nausea, mild GI disturbance.
INTRALIPID 20%
Fresenius Kabi
2N Parenteral fat emuls. Soya bean oil 100g, egg phospholipids 6g, glycerol 11g per 500ml. Emulsion 2000 kcal/L. Osmolality 350mosmol/kg water. 12 x 100ml, A89.39; 10 x 500ml, A235.71.
2N ALSO INTRALIPID 10% Soya bean oil 50g, egg phospholipids 6g, glycerol 11g per 500ml. Emulsion 1100 kcal/L. Osmolality 350mosmol/kg water. 12 x 100ml, A59.42; 10 x 500ml, A158.01.
KABIVEN
Fresenius Kabi
2J Parenteral nutritional. Glucose 19%, amino acids and electrolytes (Vamin 18 Novum), fat emulsion (Intralipid 20%). Kabiven 8 - 4, A281.88; Kabiven 11- 4, A298.84; Kabiven 14 -3, A234.42. S Parenteral nutrition for patients when oral or enteral nutrition is impossible, insufficient or contraindicated. P 19-38ml/kg body weight/day by IV inf. into central vein over 12-24 hours. Max. inf. rate 2.6ml/kg/hour. Max. dose 40ml/kg/day. Q Under 2 years: Contraindicated. 2-10 years: Initially 12.5-25ml/kg and increased by 1015ml/kg/day up to max. 40ml/kg/day. Over 10 years: As per adults.
2J ALSO KABIVEN PERIPHERAL Glucose 11%, amino acids and electrolytes (Vamin 18 Novum), fat emulsion (Intralipid 20%). Emulsion for inf. Kabiven 5 Peripheral - 4, A262.52; Kabiven 7 Peripheral - 4, A273.72; Kabiven 9 Peripheral -3, A220.14. P 27-40 ml/kg/day by IV inf. over 12-24 hours. Max. inf. rate 3.7ml/kg/hour. Max. dose 40ml/kg/day. Q Under 2 years: Contraindicated. 2-10 years: Initially 14-28ml/kg and increased by 1015ml/kg/day up to max. 40ml/kg/day. Over 10 years: As per adults.
2J ALSO STRUCTOKABIVEN Glucose 42%, amino acids solution, fat emulsion. Emulsion for inf. EF 8 -4, A301.44; EF 12 - 4, A424.24; EF 16 - 4,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS A448.48.
P 13-31ml/kg/day by IV inf. over 14-24 hours. Max. inf. rate 2ml/kg/hour. Max. dose 30ml/ kg/day. Q Under 11 years, not recommended. D Hypersensitivity to egg, soy protein. Severe hyperlipaemia/liver insufficiency/blood coagulation disorders. Inborn errors of amino acid metabolism. Severe renal insufficiency without access to haemofiltration or dialysis. Acute shock hyperglycaemia. Elevated serum levels of any included electrolytes. General contra to infusion therapy. Haemophagocytotic syndrome. Unstable conditions. B Monitor serum triglycerides. Correct electrolyte and fluid balance disturbances before starting. Caution: Conditions of impaired lipid metabolism (see SPC), metabolic acidosis, insufficient cellular oxygen supply, increased serum osmolarity, electrolyte retention. Monitor serum glucose, electrolytes, osmolarity, fluid balance, acid-base status and liver enzyme tests. Monitor blood cell count and coagulation if fat given for longer period. Renal insufficiency: Control phos. and K+ intake. Addition of trace elements and vitamins required. Anaphylactic reaction, interrupt immediately. Initiate slowly. Obese patients, base dose on estimated ideal weight. C Insulin, heparin, soybean oil may interact. A Fat overload syndrome (e.g. hyperlipaemia, fever, fat infiltration, blood disorders, coma). Excess amino acid inf (e.g. nausea, vomiting, sweating, rise in body temperature). Hyperglycaemia.
VITAMINS
AND
800 IU). Sachet, containing powder for oral susp. 30 sachets, A9.53. S Correction of combined vit. D and calcium deficiency in elderly. As an adjunct to specific treatment for osteoporosis. R 1 sachet daily. Q Not recommended. D Hypercalcaemia, hypercalciuria, severe renal insufficiency. Pregnancy, lactation. B CVD. Sarcoidosis. C Tetracycline, penicillin, neomycin, chloramphenical, fluoride, bisphosphonates, thiazide diuretics, frusemide, ethacrynic acid, cardiac glycosides. A Mild GI disturbances, hypercalcaemia.
PRIMENE 10%
bowel (discontinue). Solid dosage forms of K+ salts (may rarely lead to haemorrhage, ulceration or stenosis of the GI). GI upset.
SYNTHAMIN 9
Baxter
2N Parenteral nutritional. Amino acids 55g, electrolytes providing 9.1g N per litre. Soln. 500ml, A9.40; 1L, A17.43.
2N ALSO SYNTHAMIN 14 Amino acids 85g, with/ without electrolytes providing 14g N per litre. Soln. With elec.-500ml, A13.61; 1L, A24.21; Without elec.-500ml, A13.95; 1L, A24.75.
2N
Baxter ALSO SYNTHAMIN 17 Amino acids 100g,
2 Amino acids. Essential/non-essential amino acids; electrolyte free. Soln. 100ml, A8.16; 250ml, A11.20. S Formulated for paediatric use.
SANDOCAL 400
DIETARY SUPPLEMENTS 10.4
electrolytes providing 16.5g N per litre. Soln. 500ml, A17.89; 1L, A32.49.
VAMIN 9 GLUCOSE
Fresenius Kabi
2N Parenteral nutritional. Amino acids 70.2g, glucose
Novartis Consumer 100g, electrolytes; providing 9.4g N, 2.7 MJ/L.
2
Calcium suppl. Ca++ lactate gluconate 931mg, calcium carbonate 700mg providing calcium 400mg (10mmol), citric acid; White efferv. tab. 5 x 20, A10.30. S Osteoporosis, post-gastrectomy malabsorption, osteomalacia, rickets, pregnancy, lactation. P Osteoporosis, post-gastrectomy malabsorption, osteomalacia and rickets: 3-5 daily. Lactation. pregnancy cramps, pregnancy suppl., 1-3 daily. KAY-CEE-L Geistlich Q Half adult dose. D Severe hypercalcaemia, hypercalciuria 2O (e.g. hyperparathyroidism, vit. D overdose, K+ suppl. K+ chlor. 75mg (equiv. 1mmol K+) per ml. decalcifying tumours such as plasmocytoma and Mixture. 500ml, A3.04. skeletal metastases, immobilisation osteoporosis, S Potassium deficiency. sarcoidosis), severe renal failure, milk-alkali P 10-50ml daily in divided doses after syndrome, galactosaemia. food. B Renal impairment, electrolyte Q Contact manufacturer. imbalance. Monitor for nephrocalcinosis. Avoid vit. D Renal impairment, dehydration. D. C Digoxin, cardiac glycosides, tetracyclines. MAGNESIUM VERLA Rowa A Mild GI disturbances (constipation, 2 diarrhoea). Symptoms indicating hypercalcaemia Magnesium suppl. Magnesium aspartate 5g equiv. (nausea, vomiting, anorexia, constipation, 121.56mg (5mmol) magnesium. Granules in sachet. abdominal pain, bone pain, thirst, polyuria, muscle Sachets-20, A6.47. weakness, drowsiness, confusion). S Correction of magnesium deficiency occuring in association with diuresis, diabetic SLOW-K Novartis acidosis, renal tubular dysfunction, disordered 2O nutrition. + K suppl. K+ Cl 600mg. Orange round, biconvex, P One sachet (5g) disolved in water, 1-3 sug-ctd tab. 500, A2.96. times daily. S Potassium depletion, especially during Q Under 2 years, not recommended; 2-10 diuretic therapy. years, one sachet (5g) dissolved in water daily; P Prophylaxis, 2-3 daily. Hypokalaemia, 5-6 over 10 years, same as adult. daily in divided doses. Max. 12 daily in severe D Anuria, oliguria. depletion. B Renal dysfunction, diabetes. Q Not recommended. OSTEOFOS D3 A. Menarini D Advanced renal failure. Untreated Addison’s disease, hypo-reninaemic 2MO hypoaldosteronism, acute dehydration, extensive Calcium/vit. D suppl. Ca++ phos. 3100mg (equiv. cell destruction, metabolic acidosis, K+ sparing Ca++ 1200mg), cholecalciferol 20mcg (equiv. vit. D3 diuretics. PRESCRIBING NOTES B Peptic ulcer. Impaired renal function. INFUSIONS Hypomagnasaemia. Intravenous infusions are prohibited except C Lithium, digitalis, antihypertensives, K+ for those legitimately received in the course containing diuretics, ACE inhibitors, insulin, oral of hospital admissions or clinical hypoglycaemics, NSAIDs. investigations. A Ulceration or obstruction of the small
100ml, A4.65; 500ml, A9.66.
VAMINOLACT
Fresenius Kabi
2N Parenteral nutritional. Amino acids 65.3g, electrolytes; providing 9.3g/1 MJ/L. 100ml, A5.17; 500ml, A11.86.
VITLIPID N ADULT
Fresenius Kabi
2N Parenteral nutritional/vit. suppl. Vit. A 2500 IU, calciferol 120 IU, phytomenadione 150mcg, soya bean oil 1g, egg phospholipids 120mg, glycerol 225mg per 10ml. Emuls. in amp. 10 x 10ml, A23.87.
2N ALSO VITLIPID N INFANT Vit. A 333 IU, calciferol 100 IU, phytomenadione 50mcg, soya bean oil 100mg, egg phospholipids 12mg, glycerol 22mg per ml. Emuls. in amp. 10 x 10ml, A23.87.
10.4 VITAMINS AND DIETARY SUPPLEMENTS
ABIDEC
Chefaro
2 Vit. suppl. Vit. A 1333 IU, ergocalciferol 400 IU, thiamine 0.4mg, riboflavin 0.8mg, pyridoxine 0.8mg, nicotinamide 8mg, ascorbic acid 40mg per 0.6 ml. Drops. 25ml, A3.31. S Vitamin deficiencies. P 0.6ml daily. Q Up to 1 year, half adult dose; 1-12 years, as per adult. B Contains sucrose and arachis oil. C Levodopa.
CLONFOLIC
Clonmel
2O Folic acid suppl. Folic acid 0.4mg. Pale yellow tab. 28, A2.50 (non-GMS); 98, A3.51 (ex fact). S Prevention of first occurence neural tube defects in the foetus. P Females, 1 daily. suppl.ation should begin before women conceive and continued for first 12 weeks of pregnancy. Q Not recommended. D Vit. B12 deficiency. B Folate dependent tumours. A GI disturbances, rarely hypersensitivity
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
239
10.4 VITAMINS
AND
DIETARY SUPPLEMENTS
DIETETICS
B Large dose may cause diarrhoea. Patients at risk of hyperoxaluria. G6PD deficiency.
reactions.
CYTAMEN
UCB Prolonged use. Caution: Patients with increased
2N Vit. B12 suppl. Cyanocobalamin 1000mcg/ml. 1ml amp. 5, A1.95. S Megaloblastic anaemia, other B12 responsive macrocytic anaemias. V 250-1000mcg IM on alternate days for 1-2 weeks, then 250mcg weekly until blood count is normal. Maintenance, 1000mcg monthly. D Megaloblastic anaemia of pregnancy. See SPC. C Chloramphenicol, oral contraceptives. A Rare hypersensitivity reactions.
plasma iron. C Fluphenazine. A Nausea, vomiting, abdominal cramping, headache.
KIDDI PHARMATON Boehringer Ing. SM 2
Vit./mineral suppl. Each 7.5ml contains: lysine 150mg, thiamine 1.5mg, riboflavin 1.7mg, pyridoxine 3mg, nicotinamide 10mg, dexpanthenol 5mg, cholecalciferol (vit D3) 7.5mcg (300 IU), alpha-tocopherol (acetate) 7.5mg, Ca++ glycerophosphate soln. (equiv. to calcium 65mg, DECAVIT Rowa phosphorus 100mg). Orange flavoured syrup. 100ml, A3.22; 200ml, A4.62. 2 S Supplement for persons requiring a Multivitamin. Vit. A 800mcg, vit. E 10mg, thiamine dietary adjunct (convalescence, loss of appetite, (B1) 1.4mg, riboflavin (B2) 1.6mg , vit. B6 2mg, vit. correction of specific vitamin deficiencies). B12 1mcg, folic acid 200mcg, niacin (B3) 18mg, vit. P 15ml daily. C 60mg. Orange-red soft gelatin cap. 30, A2.67; Q 1-5 years: 7.5ml daily; over 5 years: 15ml 60, A5.08. per day. Taken v-1 hours before meals, ideally S Vitamin deficiency, diet breakfast or lunch. May be diluted with water or supplementation. mixed with food. P 1 daily, or as directed. D Hypercalcaemia, hypercalciuria, renal Q Under 6 years, not recommended. insufficiency, vit. D containing products, B Pregnancy. hypervitaminosis D. C Levodopa. B Hypervitaminosis. Pregnancy, lactation.
HALIBORANGE
Seven Seas
MINADEX TONIC
Seven Seas
B Contains ferric ammonium citrate, glucose, sucrose, Na+ metabisulphite, soya bean oil. Hyprevitaminoses risk with prolonged excessive ingestion of vitamin D. Pregnancy, lactation. C Caution: Medicines containing iron or vitamins A/D.
NAUDICELLE
Bio Oil Research
O Fatty Acids suppl. Evening primrose oil 552mg. Clear soft gelatine cap. 100, A11.87; 336, A32.25. S Essential fatty acids suppl. P 2 three times daily with water. A Softening of stools. Headache (when taken as single dose). Allergy.
NEO-CYTAMEN
UCB
2N Vit. B12 suppl. Hydroxocobalamin 1000mcg/ml. 1ml amp. 5, A12.27. S Megaloblastic anaemia, other B12 responsive macrocytic anaemias, tobacco amblyopia, Leberâ&#x20AC;&#x2122;s disease. V Initially 250-1000mcg IM on alternate days for 1-2 weeks then 250mcg weekly until blood count is normal. Maintenance, 1000mcg every 2-3months. See lit. for amblyopias. D Megaloblastic anaemia of pregnancy. See SPC. C Chloramphenicol, oral contraceptives. A Rare hypersensitivity reactions.
2
2
Vit. C Suppl. Ascorbic acid 1000mg. White, round, flat bevelled-edge effervescent tab. for dissolution, with citrus odour. 20, A3.27. S Prophylaxis and treatment of vitamin C deficiency. V Adult and children q 12 years: 1 tab. dissolved in water daily. D Ascorbic acid q1g daily in patients with hyperoxaluria.
OCUVITE LUTEIN FORTE
Vit./mineral suppl. Vit. A 0.650mg, colecalciferol 0.065mg, iron 12mg, K+ 2.25mg, Ca++ 11.25mg, manganese 0.38mg, copper 0.5mg. Oral emulsion with orange odour and taste. 200ml, A2.63. S Vitamin and mineral deficiency and as an appetite stimulant during and after illness. P 10ml three times daily. Q 6 months-3 years: 5ml twice daily. 3-12 years: 5ml three times daily.
K
PRESCRIBING NOTES VITAMINS Vitamin A (retinol) Deficiency causes ocular defects and increased susceptibility to infections. There is evidence to suggest it can cause birth defects so women who are pregnant or trying to conceive should not take supplements or eat foods rich in the vitamin (liver). B vitamins (thiamine, riboflavin, niacin, folic acidâ&#x20AC;Ś) Supplementation is suggested in the elderly and alcoholics, the latter may need parenteral supplementation. Riboflavin (vitamin B2) deficiency is classically associated with eye, mouth and skin symptoms (angular cheilitis, inflammation in the mouth, a sore and burning tongue, photophobia and dermatitis). Prolonged use of high doses of pyridoxine (vitamin B6) has raised concerns about possible long term toxicity. Folic acid (vitamin B9) deficiency may cause megablastic anaemia. Deficiency during pregnancy can lead to neural tube defects. It is recommended that those planning pregnancy should take 400mcg of folic acid daily until the twelfth week of pregnancy, those already pregnant should commence and also continue until the twelfth week. If there is a history of neural tube defects in the family or there has been a previous affected pregnancy then the dose should follow the same schedule but be increased to 4mg daily. Folate rich foods are all leafy green vegetables. The vitamin is easily destroyed by the cooking process. Pernicious anaemia is treated with cobalamin (vitamin B12). A deficiency in vitamin B12 can also be caused by poor diet especially those on a vegetarian diet as the vitamin is predominantly from animal origin. Vitamin C (ascorbic acid) Deficiencies cause scurvy, which is not common; milder deficiencies can be seen in the elderly. Vitamin D2 and vitamin D3 Deficiency causes rickets in children and osteomalacia in adults. It is obtained from the action of UV light on the skin. Those who do not have access to sunlight especially during the winter months may be at particular risk of deficiency. Patients with renal failure develop vitamin D resistant hypocalcaemia and consequently secondary hyperparathyroidism and osteodystrophy. Oral supplementation may not be sufficient and the use of alfacalcidol or calcitriol is indicated. Vitamin E (tocopherol) Deficiency is rare and usually due to malabsorption, cystic fibrosis, cholestasis. Vitamin K It is necessary for blood clotting and calcification of bone. It is a fat soluble vitamin and for patients with malabsorption a water soluble preparation menadiol sodium phosphate must be used. Infants following birth are usually deficient in Vitamin K and consequently all newborns should receive Vitamin K to prevent vitamin K deficiency bleeding (haemorrhagic disease of the newborn). References available on request.
240
Dr. Mann
Vinamins/minerals/carotenoids. Ascorbic acid 60mg, vit E 8.8mg, zinc 5mg, selenium 20mcg, lutein 6mg, zeaxanthin 0.5mg. Orange film-ctd tab. 30, A11.97. S To promote healthy nutrition of the eye and to increase macular density and help prevent oxidative damage by free radicals in age related eye diseases. P 1 daily with meals or as instructed by Ophthalmic Surgeon. Q Not applicable.
ONE-ALPHA
LEO Pharma
2MO Vit. D suppl. Alfacalcidol 0.25mcg, 1mcg. White, brown cap. 0.25mcg-30, A4.23. 1mcg-30, A12.61.
2MO ALSO ONE-ALPHA DROPS Alfacalcidol 2mcg/ml (0.1mcg per drop). 10ml, A30.31. S Renal bone disease, hypoparathyroidism, prior to parathyroidectomy to minimise post-operative hypocalcaemia. Nutritional, malabsorptive and vit. D resistant rickets; osteomalacia. Neonatal hypocalcaemia. Osteoporosis. Treatment should be initiated in hospital by specialist. P Initially 1mcg daily adjusting according to response. See SPC. R 0.5mcg daily may be sufficient. Q Under 20kg, initially 0.05mcg/kg daily; neonates and premature infants 0.05-0.1mcg/kg/ day. V Over 20kg initially 1mcg daily. See lit. D First trimester of pregnancy. B Monitor plasma Ca++. C Barbiturates, anticonvulsants.
PABRINEX IV
Archimedes
2N
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS Vit. suppl. Thiamine 250mg, riboflavine 4mg, pyridoxine 50mg (amp No.1); nicotinamide 160mg, ascorbic acid 500mg, anhydrous glucose 1g (amp No.2). Sln for inj. or inf. 5ml No.1 and 5ml No.2 (blue carton). 10 pairs, A45.20. S Rapid therapy of severe depletion or malabsorption of vit. B and C (alcoholism, post acute infections, post-operatively, psychiatric states). Maintain levels of vits. B and C in patients on chronic intermittent haemodialysis. P Inject the contents of 2 to 3 pairs of ampoules at intervals of 8 hrs. Contents of each pair of amps (total 10ml) drawn up into syringe, mix just before use and admin. by slow IV inj. over 10 mins. By drip, dilute with 50 to 100ml physiological saline or 5% glucose and infuse over 15 to 30 mins. B Resuscitation facilities must be available. C Levodopa. A Anaphylaxis.
METABOLISM DISORDERS B Withhold other vit. D preps. Pregnancy. Monitor serum Ca++ levels regularly. A Hypercalcaemia, hypercalciuria.
RUBEX
Vit. D suppl. Calcitriol 0.25mcg. Caps. One half brown-red to orange-grey opaque, the other white to grey-yellow or grey-orange opaque. 0.25mcg-100, A22.73. S Correction of calcium and phosphate metabolism in patients with renal osteodystrophy. Postmenopausal osteoporosis. P Renal osteodystrophy, 1-2mcg daily increasing if necessary by increments of 0.250.5mcg to max. 2-3mcg daily. Postmenopausal osteoprosis, 0.25mcg twice daily. Q Not recommended. D Metastatic calcification, hypercalcaemia.
2K ALSO RUBEX CHEWABLE Ascorbic acid 250mg. Orange flavour tab. 50, A1.76; 150, A4.32.
2K
Pharmacia
2N Parenteral vit.suppl. Thiamine 3.2mg, riboflavine 3.6mg, pyridoxine 4mg, cyanocobalamin 5mcg, nicotinamide 40mg, folic acid 0.4mg, biotin 60mcg, pantothenic acid 15mg, ascorbic acid 100mg. Powder in vial. 10, A24.49. S Multivitamin and mineral suppl. P 1 daily. Q See lit.
10.5 METABOLISM DISORDERS AND OBESITY
Roche
2NO Lipase inhibitor. Orlistat 120mg. Turquoise cap.
Vit. C suppl. Ascorbic acid 50mg, 100mg, 200mg, 500mg. Tab. 50mg-100, A1.04; 100mg-100, A1.68; 200mg-100, A2.26; 500mg-100, A4.85. S Prophylaxis and treatment of ascorbic acid deficiency.
SOLIVITO N
XENICAL
10.5
Ricesteele marked ROCHE XENICAL 120. 84, A55.93.
2K
ALSO RUBEX EFFERVESCENT Ascorbic acid 1g. Orange or lemon flavoured effervesc. tab. 10, A1.58; 24, A3.22. P Up to 1000mg daily or as directed. D Hyperoxaluria (ascorbic acid doses q1g PHARMATON Boehringer Ing. SM daily), diabetics. B Risk of hyperoxaluria, G6PD deficiency. 2 C Fluphenazine. Vit./mineral suppl. Panax ginseng extract 40mg, vit. A 2667 IU, vit. B1 1.4mg, vit. B2 1.6mg, vit. B6 A Nausea, vomiting, abdominal cramping, 2mg, folic acid 100mcg, vit. B12 1mcg, vit. C 60mg, headaches, renal Ca++ calculi. vit. D3 200 IU, vit. E 10mg, nicotinamide 18mg, SHS iron 10mg, Ca++ 100mg, copper 2mg, magnesium SERAVIT 10mg, zinc 1mg, lecithin 100mg, biotin 150mcg, 1O selenium 50mcg. Cap. 30, A9.24; 100, A24.63. Vit/mineral suppl. Carbohydrate (maltodextrin) S Fatigue and weakness associated with 67%, vitamins, trace elements, minerals; Na+ and stress, convalescence, or symptoms of ageing, K+ low. Powder 268kcals/100g. 200g, A19.59. impaired general health. S Therapeutic restricitve diets in infants/ P 1-2 daily for 8-12 weeks. children. Q Not recommended. D Pregnancy, lactation. Hypercalcaemia, SLOW-K Novartis hypercalciuria, haemochromatosis, iron overload 2O syndrome, hypervitaminosis A or D, renal K+suppl. K+ Cl 600mg. Orange round, biconvex, insufficiency. sug-ctd tab. 500, A2.96. B Family history of haemochromatosis. Prolonged use. Consult doctor if no improvement S Potassium depletion, especially during diuretic therapy. within 4 weeks. Peanut or soya allergy. C Retinoid (e.g. against acne) or vitamin D P Prophylaxis, 2-3 daily. Hypokalaemia, 5-6 daily in divided doses. Max. 12 daily in severe therapy (contraindicated). Caution: CNS depletion. depressants or stimulants, levodopa, Q Not recommended. antihypertensives. D Advanced renal failure. Untreated REDOXON Bayer HealthCare Addison’s disease, hypo-reninaemic hypoaldosteronism, acute dehydration, extensive 2 cell destruction, metabolic acidosis, K+ sparing Vit. suppl. Ascorbic acid 1g. White effervescent diuretics. tab. blackcurrent, orange and lemon flavoured. B Peptic ulcer. Impaired renal function. 15, A3.32; 30, A5.32. Hypomagnasaemia. S Vitamin C deficiency. C Lithium, digitalis, antihypertensives, K+ P Up to 3g daily. containing diuretics, ACE inhibitors, insulin, oral Q Under 4 years, not recommeded. 4-12 hypoglycaemics, NSAIDs. years, half adult dose. Over 12 years, threeA Ulceration or obstruction of the small quarters adult dose. bowel (discontinue). Solid dosage forms of K+ salts A Diarrhoea. (may rarely lead to haemorrhage, ulceration or ROCALTROL Roche stenosis of the GI). GI upset.
2MO
AND OBESITY
S Adjunct to diet in obese patients with body mass index 30kg/m2 and greater, or body mass index 28kg/m2 and greater with associated risk factors. P 1 cap. before, during or up to 1 hour after each main meal. Discontinue after 12 weeks if 5% of body weight is not lost. Q Not recommended. D Chronic malabsorption syndrome, cholestasis. Pregnancy, lacation. B Advise adherence to balanced diet, rich in fruit and vegetables and containing approx. 30% calories from fat. Elderly (no data). C Fat soluble vits., acarbose, anorectic agents, anticoagulants, cyclosporin. A GI disturbance, respiratory infection, influenza. Headache, menstrual irregularity, anxiety, fatigue, UTI. Raised liver enzymes (very rarely), hepatitis.
10.6 FOODS
ADAMIN-G
SHS
1O Oral nutritional. L-Glutamine. Powder. 20x5g, A21.61. S Conditions requiring increased LGlutamine e.g. catabolic stress, post surgery, multiple trauma, sepsis, chemo/radiotherapy.
ADD-INS
SHS
1 Oral nutritional. Flavourless phenylalanine free protein substitute containing essential and non essential amino acids, carbohydrates, fat, vitamins, calcium, phosphorous, magnesium and trace elements. 60 x 18.2g, A430.01 S Dietary treatment of phenylketonuria. V Aged 4 years and above.
ALICALM
Nutricia
1O Oral nutritional. Carbohydrate 58g, fat 17.5g (LCT 52%, MCT 48%), protein 15g per 100g with vitamins, minerals and trace elements. Nutritionally complete powder. 400g, A23.69. S Paediatric Crohn’s Disease. For children over 5 years old.
AMINOGRAN
UCB
1O Oral nutritional. Essential, non-essential amino acids, phenylalanine-free. Powder 1.68 MJ/100g. 500g, A66.71. S Phenylketonuria.
ANAMIX
SHS
1O PKU ANAMIX INFANT (Formerly known as XP ANALOG LCP). Oral nutritional (paediatric). Carbohydrate 54%, protein equiv. 13%, fat 23% (arachidonic acid, docosahexaenoic acid), vitamins, minerals, trace elements. Phenylanaline-free powder. 475kcals/100g. 400g, A33.97. S Phenylketonuria in infants 0-1 years
1O ALSO HCU ANAMIX INFANT Carbohydrate 54%, protein equiv. 13%, fat 23%, vitamins, minerals,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
241
10.6 FOODS
DIETETICS
trace elements. Methionine free powder. 475kcals/ 100g. 400g, A38.74. S Vit.B6 non-responsive homocystinuria and hypermethioninaemia in infants, aged 0-1 year.
1O ALSO MSUD ANAMIX INFANT Essential/non essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements. Leucine, isoleucine, valine free. Powder. 400g, A38.74. S Maple syrup urine disease in infants age 0-1 years.
suitable for patients with hyperglycaemia, impaired glucose tolerance, Type 1 and Type 2
electrolyte restrictions.
CALSHAKE
Fresenius Kabi diabetes mellitus.
1O
Q Under 3 years, unsuitable.
Oral nutritional. Protein (milk) 4.6g, fat (vegetable oil) 23.5g, carbohydrate (maltodextrin) 66.5g per 100ml. Powder. 496kcal/100g (4 flavours and neutral). Unsuitable as sole nutritional source. Box of 7x 87g sachets, A19.62. S Increased energy and protein requirements (e.g.cystic fibrosis, oncology, patients suffering from malnutrition). Q Under 1 year, unsuitable.
DIBEN
Fresenius Kabi
1O
Oral/enteral nutritional. Protein (milk) 4g, carbohydrate (modified strach, fructose, maltodextrins) 8.3g, fat 4,5g, fibre 2/2.3g per 100ml. Nutritionally complete. Lactose- and gluten- free. Oral- EasyBottle with straw 200ml (3 flavours) 0.9kcal/ml, A 2.50. Liquid tube feedANTOX Pharma Nord 500ml EasyBag 1kcal/ml, A 5.64. CAPRILON SHS S Diabetes mellitus, impaired glucose Y tolerance in malnourished patients or those at risk Oral nutritional. L-Methionine 480mg, vit. C 1O of malnutrition. 120mg, vit. E 35mg, selenium 50mcg. Yellow oval Oral nutritional (paediatric). Fat (75% medium Q Under 3 years, not suitable. A tab. 180, 79.46. chain triglycerides, C8 and C10 fatty acids 28%), S Chronic pancreatitis. protein 12%, carbohydrate 55% (glucose syrup DUOBAR SHS P Up to 6 daily. 44%, lactose 11%), vitamins, minerals, trace Q Under 16 years, at discretion of 1O elements. Whey based infant formula containing physician. Under 5 years, not recommended. MCT fat. 522kcals/100g. Nutritionally complete. Oral nutritional. Fat, carbohydrate. High energy D Suspected or proven schizophrenia. 420g, A18.73. bar, 292 kcal/45g in 3 flavours. 8x42g, A16.16. Renal insufficiency. Parenteral use. Pregnancy, S Hepato-biliary or pancreatic disease, S Conditions requiring a high calorie, low lactation. stagnant loop syndrome. Conditions where fluid diet e.g. amino acid metabolism disorders, B Use under medical supervision. Not digestion, absorption or transport of normal protein restricted diets, renal and liver diseases in suitable as sole source of nutrition. dietary fat is disrupted, leading to steatorrhoea. children and adults.
ARGININE AA SUPPLEMENT Vitaflo CAROBEL-INSTANT 1O
Cow & Gate
1O
Thickening agent. Maltodextrin, carob bean gum, Ca++ lactate. Powder 251kcal/100g. 135g, A4.18. S Infantile vomiting and posseting when no organic cause known. Habitual and recurrent vomiting, e.g. gastrooesophageal reflux. CALOGEN Nutricia Q Suitable for infants and children. D Obstructive lesions (e.g. pyloric stenosis, 1O gastroenteritis), galactosaemic infants (monitor red Oral nutritional. A high energy, long chain cell galactose-1-phosphate). triglyceride fat emulsion. 450kcals and 50g fat per 100ml (2 flavours and neutral). 200ml, A5.24; CUBITAN Nutricia 500ml A12.71. S Renal failure, other conditions requiring 1 O Oral nutritional. Protein 20g, arginine enriched 3g, a high energy diet, with/without fluid and vitamins, minerals, trace elements per 200ml. Nutritionally balanced sip feed. (3 flavours). 1.25 PRESCRIBING NOTES kcal/ml. Plastic bottle with straw- 200ml, A2.07. FOODS S Assist the healing of pressure sores. Products can be classified into those indicated for Q Under 3 years, not recommended. disease states, allergic conditions, malnutrition
242
SHS
1O
Oral nutritional. Arginine 500mg on a carbohydrate base. Powder. 30, A58.23. S Dietary management of Inborn Errors of Protein Metabolism.
and metabolic and absorption problems. Renal disease requires patients to maintain a low protein, high energy diet, the calories being provided by fat emulsions or carbohydrate glucose solutions. Hepatic and pancreatic disease require diets where fats can be easily absorbed and provided by products high in medium chain triglycerides. Errors of metabolism (amino acid disorders) are managed with products, which do not contain the substance that cannot be metabolised. Products for food intolerance (gluten, lactose) are very similar in their approach. Milk intolerance can be treated using cows milk substitutes such as soya based milks; those who cannot tolerate the soya preparation may respond to preparations containing hydrolysed proteins. There is a wide range of preparations available described as high energy and nutritionally complete which are useful for general malnutrition and patients who require dietary supplementation due to ill health, age, immobility and lack of appetite. References available on request.
DUOCAL SUPER SOLUBLE
CYSTINE AA SUPPLEMENT
Vitaflo
1O Oral nutritional. L-Cystine 500mg on a carbohydrate base. Sachets. 30 x 4g, A58.23. S Inborn errors of protein metabolism in people from 12 months to 10 years of age.
Oral nutritional. Carbohydrate 72.7%, fat (35% MCT, 65% LCT) 22.3%, gluten-, protein- and lactose-free, electrolyte low. Powder. 492 kcal/ 100g. Not nutritionally complete. 400g, A18.59.
1O ALSO DUOCAL LIQUID Carbohydrate 23.4%, fat (30% MCT, 70% LCT) 7.1%, gluten-, protein- and lactose-free, electrolyte low. Liquid. 158 kcal/ 100ml. Not nutritionally complete. 250ml, A4.13.
1O ALSO MCT DUOCAL Carbohydrate 74%, fat (83% MCT) 23.2%, gluten, protein and lactose-free, electrolyte low. Powder. 486kcal/100g. 400g, A22.73. S Renal failure, liver cirrhosis, disaccharide intolerance (without isomaltose intolerance), disorders of amino acid metabolism, whole protein intolerance, malabsorption states, other conditions requiring high energy/low fluid diet.
EAA SUPPLEMENT
Vitaflo
1O
Oral nutritional. Essential amino acids, carbohydrate, vitamins, minerals and trace elements. Tropical flavoured powder. 50 x 12.5g sachets, A290.94. DIALAMINE SHS S Disorders of protein metabolism where essential amino acids are required; urea cycle 1O disorders. Oral nutritional. 30% essential amino acids, Q Suitable for children from 3 years of carbohydrate, flavourings and low levels of minerals. Orange flavoured powder. 200g, A37.74. age. S Advanced chronic renal failure and SHS certain urea cycle disorders e.g. OTC/CPS deficiency EASIPHEN 1O in infants over 6 months, children and adults. Q Infants under 6 months, not suitable. Oral nutritional. Essential/non-essential amino acids, carbohydrates, fat, vitamins, minerals and DIASIP Nutricia trace elements. Ready to drink phenylalanine free liquid in 2 flavours. 250ml, A10.13. 1O S Phenylketonuria in children over 8 years Oral nutritional. Protein 4.9g, fat 3.8g, and adults. carbohydrate 11.7g, fibre 2g per 100ml; gluten Q Children under 8 years, not suitable. free. 1kcal/ml (3 flavours). Nutritionally complete. Plastic bottle with straw-200ml, A2.50. ELEMENTAL 028 EXTRA SHS S Nutritionally complete supplement
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS
FOODS 10.6
EXCIPIENTS Many products contain ingredients other than the active ingredient(s) listed in this index; these are known as excipients. These are “inert” substances used as a diluent or vehicle for a drug and may cause unwanted effects in some individuals. The table below contains a list of excipients and when they should be avoided, when caution should be exercised or their possible side effects.
EXCIPIENT
PRECAUTION
Lactose
Should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Fructose Mannitol Sucrose Sorbitol
Should not be administered to patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Aspartame
Caution in phenylketonuria.
Ethanol Alcohol
May be harmful for those suffering from liver disease, alcoholism, epilepsy, brain injury or disease, as well as for pregnant women and children. Possible CNS and other effects.
Cetyl alcohol Propylene glycol Parabene Methyl parahydroxybenzoate Propyl parahydroxybenzoate Chlorocresol Metacresol Sunset yellow Polyethoxylated castor oil
May cause allergic reactions.
Associated with a fatal 'gasping syndrome' in neonates. Benzyl alcohol
May cause toxic and anaphylactoid reactions in infants and children up to 3 years of age.
Cetostearyl alcohol
May cause local skin reactions.
Arachis oil
Should not be taken/applied by patients known to be allergic to peanut. Patients with soya allergy should also avoid.
This table was compiled using a number of SPCs. References 1- IPHA website. www.medicines.ie. October 2006.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
243
10.6 FOODS
DIETETICS
1KO Oral nutritional. Protein (essential, non-essential amino acids) 12.5g, carbohydrate (sugar, dried glucose syrup) 55g (flavoured), fat (35% MCT, 65% LCT)17.45g, vitamins, minerals, trace elements per 100g. 427kcals/100g (flavoured); 443kcals/100g (unflavoured). 100g A7.41. S GI tract impairment (e.g. Crohns disease, inflammatory bowel disease, short bowel syndrome, bowel fistula).
complete. 250ml can (3 flavours), A3.05. S Disease related malnutrition, pre and post operatively undernourished patients, inflammatory bowel disease, total gastrectomy, dysphagia, bowel fistulae, anorexia nervosa, short bowel syndrome, intractable malabsorption. Q Under 5 years, caution. Under 1 year, not recommended.
malabsorption and immobile patients Q Under 5 years, caution. Under 1 year, not recommended.
ENSURE PLUS HP
Abbott
1O
Oral nutritional. Energy 250kcal. Protein 15.8g, fat 6.6g, carbohydrate 31.8g per 200ml. Gluten- and clinically lactose-free. 1.25 kcal/ml. Nutritionally ENSURE PLUS Abbott complete. 200ml bottle with straw attached (2 1O 1O flavours), A2.07. ALSO ELEMENTAL 028 EXTRA LIQUID Protein S Acute or chronic wounds or patients Oral/enteral nutritional. Energy 150kcal. Protein (essential, non-essemtial amino acids) 2.5g, with poor wound healing. 6.25g, fat 4.9g, carbohydrate 20.2g per 100ml; carbohydrate (dried glucose syrup, sugar) 11g, fat gluten- and clinically lactose-free. 1.5 kcal/ml. Q Under 6 years, caution. Under 1 year, (coconut, hybrid safflower and rapeseed oil) 3.5g, Nutritionally complete. Oral: 200 bottle with straw not recommended. vitamins, minerals, trace elements per 100ml. attached (12 milkshake and 3 yoghurt style ENSURE PLUS JUCE Abbott 215kcals/250ml (3 flavours) 250ml, A3.83. flavours), A2.26. Enteral: Ready-to-Hang -500ml S GI tract impairment (e.g.Crohns disease, (flavoured), A6.21; 1L, A12.11; 1.5L, A18.16. 1O intractable malabsorption, short bowel syndrome, 1 O (FORMERLY KNOWN AS ENLIVE PLUS). Oral bowel fistula). ALSO ENSURE PLUS SAVOURY Energy 375kcal, nutritional. Energy 305kcal. Protein 9.6g, fat 0g, protein 15.6g, fat 12.3g, carbohydrate 50.5g. carbohydrate 65.4g per 200ml. Gluten and EMSOGEN SHS Gluten- and clinically lactose- free. 1.5kcal/ml. clinically lactose free. 1.5 kcal/ml. Unsuitable as a Nutritionally complete. 250ml can (2 flavours), 1O sole nutritional source. 200ml bottle with straw A2.26. Oral nutritional. Carbohydrate 60%; fat (83% attached (4 flavours), A2.42. MCT, 17% LCT) 16.4%; protein equiv. 12.5% with S Disease related malnutrition, pre and S Disease related malnutrition, pre and post operatively undernourished patients, vitamins, minerals, trace elements. Powder post operative undernourished patients, inflammatory bowel disease, total gastrectomy, 438kcal/100g (flavoured and unflavoured). inflammatory bowel disease, total gastrectomy, dysphagia, bowel fistulae, anorexia nervosa, short dysphagia, bowel fistulae, anorexia nervosa, short Nutritionally complete. 100g, A7.57. bowel syndrome, intractable malabsorption, poor bowel syndrome, intractable malabsorption, fat S Severe malabsorption (e.g. cystic appetite. fibrosis, HIV infection), where very long chain intolerance, convalescence, oncology, taste Q Under 6 years, caution. Under 1 year, triglycerides are poorly tolerated. alterations/aversions to ’milky’ supplements. not recommended. Q Under 1 year, unsuitable. Q Under 5 years, caution. Under 1 year, not recommended. `
ENERGIVIT
SHS
ENSURE PLUS CREME
Abbott
1O
1O
Oral nutritional. Energy 171kcal. Protein 7.1g, fat 5.59g, carbohydrate 23g per 125g, vitamins, minerals and trace elements. Gluten and clinically lactose free. 1.5kcal/ml. Nutritionally complete 125g pot (4 flavours), A2.42. S Disease related malnutrition, dysphagia, swallowing difficulties, total gastrectomy, pre and postoperative preparation of patients who are malnourished or patients who are looking for an ENFAMIL O-LAC WITH LIPIL Mead Johnson alternative mouth feel. Q Under 6 years, caution. Under 1 year, 1O not recommended. Oral nutritional. Protein (milk) 10.9g, carbohydrate (glucose polymers) 55g, fat (vegetable oils, LCPs) ENSURE PLUS FIBRE Abbott 28g, vitamins, minerals, trace elements. Lactose-, 1O sucrose-, fructose- and gluten-free. Powder. 520kcal/100g. Nutritionally complete. 400g, A5.26. (FORMERLY KNOWN AS ENRICH PLUS). Oral nutritional. Energy 305kcal. Protein 12.5g, fat S Lactose intolerance. 9.84g, carbohydrate 40.4g, fibre 5.0g (of which ENSHAKE Abbott FOS 2.5g) per 200ml; gluten- and clinically lactosefree. 1.5kcal/ml. Nutritionally complete. 200ml 1O bottle with straw attached (6 flavours), A2.52. Oral nutritional. Energy 434 kcal. Protein 8.1g, fat S Disease related malnutrition, pre and 15.1g, carbohydrate 66.6g, vitamins and minerals postoperative undernourished patients, per 96.5g sachet. Powder. Unsuitable as a sole inflammatory bowel disease, total gastrectomy, nutritional source. Gluten free. Box of 6 x 96.5g post-operative dysphagia, bowel fistulae, anorexia sachets (2 flavours), A16.62. nervosa, short bowel syndrome, intractable S Increased energy and protein malabsorption, immobile patients and the elderly. requirements (malnutrition, post operative, Q Under 6 years, caution. Under 1 year, oncology, cystic fibrosis). not recommended. P Mix 1 sachet with 240ml whole milk. 1O Q Under 6 years, half sachet mixed with ALSO ENRICH Energy 256kcal. Protein 9.4g, fat 240 ml milk. Under 1 year, not recommended. 8.8g, carbohydrate 34.9g, dietary fibre 3.4g per B Not lactose free. 250ml; gluten- and clinically lactose-free. 1 kcal/ml. Nutritionally complete. 250ml can (1 flavour), ENSURE Abbott A 3.56. 1O S Disease related malnutrition, pre- and Oral nutritional. Protein 10.0g, fat 8.4g, post-operative undernourished patients, carbohydrate 33.9g per 250ml. Gluten- and inflammatory bowel disease, total gastrectomy, clinically lactose-free. 1.0kcal/ml. Nutritionally dysphagia, short bowel syndrome, intractable Oral nutritional. Carbohydrate, fat, vitamin, minerals and trace elements. Powder, 492kcal/ 100g. 400g, A23.66. S Infants and children following a protein restricted diet who require additional energy, vitamins, minerals and trace elements. P Not applicable.
244
ENSURE TWOCAL
Abbott
1 Oral/Enteral nutritional. Energy 400kcal, protein 16.8g, fat 17.8g, carbohydrate 42.0g per 200ml. Gluten and clinically lactose free. 2 kcal/ml. Nutritionally complete. 200ml pack with straw attached (4 flavours), A2.71. S General surgery, sepsis, trauma, post CVA, malignant disease, poor wound healing, fluid restriction. Q Under 6 years, use with caution. Under 1 year, not recommended.
FLAVOUR SACHETS
Nestle Clinical
1O Flavouring agent. Lemon/lime, strawberry, banana, chocolate, coffee flavours. 18 x 3g, A9.07. S For use with Peptamen (vanilla). Q Under 5 years, caution. Infants under 1 year, unsuitable.
FLAVOURPAC
Vitaflo
1O Oral nutritional. Sugar, malic acid, citric acid, flavourings. Sachets (6 flavours). 30 x 4g, A15.00; 120 x 4g, A60.00. S Range of flavours to be used in conjunction with Vitaflo’s range of unflavoured gel or express protein substitutes. Q Under 12 months, not suitable. V v-1 sachet per sachet of unflavoured gel, 1 sachet per sachet of unflavoured express.
FORTICARE
Nutricia
1O Oral nutritional. Protein 9g, fat 5.3g, carbohydrate 19.1g, fibre 2.1g per 100ml. 1.6kcal/ml. Lactose and gluten free. 3 flavours (Orange-Lemon, PeachGinger, Cappuccino). Nutritionally complete. 125ml
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS
FOODS 10.6
Tetra, A2.63. S Energy dense, low volume, EPA enriched feed indicated for the dietary management of patients with cancer related malnutrition. Q 3-6 years, caution. Under 3 years, not suitable.
bowel fistulae, disease related malnutrition, anorexia nervosa. Q Infants, unsuitable.
1O
ALSO FORTISIP MULTI FIBRE As for Fortisip with 4.5g fibre. 7 flavours (sweet and savoury). Nutritionally complete. Plastic bottle with straw. 200ml, A2.52. FORTICREME COMPLETE Nutricia S As for Fortisip. Suitable for patients with diabetes if sipped slowly over a period of 20 1O Oral nutritional. Protein 12g, fat 6g, carbohydrate mins. or more. Q Children under 6 years, not suitable. 24g per 125g, vitamins, minerals, trace elements, D Galactosaemia. gluten-free. 201kcal/125g (4 flavours). 125g, B Not suitable for patients requiring fibre A2.34. free diet. S Patients with swallowing difficulties, elderly patients with poor appetite. FORTISIP YOGURT STYLE Nutricia B Not lactose-free.
FORTIJUCE
1O Nutricia Oral nutritional. Protein 6g, fat 5.8g, carbohydrate
1O Oral nutritional. Protein 4g, carbohydrate 33.5g per 100ml. Lactose- and gluten-free. 1.5kcal/ml (7 flavours). Unsuitable as sole nutritional source. Nutritionally complete in minerals, vitamins and trace elements. Plastic bottle with straw-200ml, A2.42. S Short bowel syndrome, intractable malabsorption, pre- and post-operative preparation of under nourished patients, inflammatory bowel disease, total gastrectomy, bowel fistulae, disease related malnutrition, anorexia nervosa. Q Under 3 year, unsuitable.
FORTIMEL
Nutricia
1O Oral nutritional. Protein (skimmed milk) 10g, fat (corn oil) 2.1g, carbohydrate (lactose, sucrose, maltodextrin) 10.3g, vitamins, minerals, trace elements, gluten-free, low Na+. Liquid, 100kcal/ 100ml (3 flavours). Nutritionally complete. Plastic bottle with straw. 200ml, A2.07. S Dietary management of hypoproteinaemia, wound healing, continuous ambulatory peritoneal dialysis.
FORTINI
Nutricia
1O Oral nutritional. Protein 3.4g, carbohydrate 18.8g, fat 6.8g per 100ml plus vitamins, minerals and trace elements. Gluten-, lactose-free. 1.5kcal/ml (2 flavours). Nutritionally complete. Plastic bottle200ml, A3.67.
1O ALSO FORTINI MULTI FIBRE As above with 1.5g multi fibre per 100ml. Gluten-, lactose-free. 1.5kcal/ml (4 flavours). Plastic bottle-200ml, A3.84. S Children from 1 year (or q8kg) who are unable to meet their nutritional requirements from other foods, or as a complete feed for children 1-6 years (or 8-20kg). Q Infants under 1 year, unsuitable.
FORTISIP
Nutricia
1O Oral nutritional. Protein 6g, fat 5.8g, carbohydrate 18.4g/100ml. Lactose, gluten free. 1.5kcal/ml (7 flavours and neutral). Nutritionally complete. Plastic bottle with straw. 200ml, A2.26. S Short bowel syndrome, intractable malabsorption, pre- and post-operative preparation of under nourished patients, inflammatory bowel disease, total gastrectomy,
18.7g per 100ml. Energy dense, yogurt tasting suppl. 1.5kcal/ml (3 flavours). Nutritionally complete. Plastic bottle with straw-200ml, A2.26. S Short bowel syndrome, intractable malabsorption, pre- and post-operative preparation of under nourished patients, inflammatory bowel disease, total gastrectomy, bowel fistulae, disease related malnutrition, anorexia nervosa. Q Under 3 years, unsuitable. B Not lactose-free.
short bowel syndrome, intractable malabsorption, pre-operative preparation of undernourished patients, IBD, total gastrectomy, bowel fistulae. CAPD and haemodialysis. Elderly. Q Under 5 years, caution. Under 1 year, unsuitable.
1O ALSO FRESUBIN ENERGY Protein (milk) 5.6g, fat (vegetable, MCT) 5.8g, carbohydrate (maltodextrin) 18.8g per 100ml, lactose and gluten free. Nutritionally complete. Oral- EasyBottle with straw 200ml (8 flavours and neutral) 1.5kcal/ml, A2.26. Liquid tube feed- 500ml EasyBag A5.99; 1L, A11.87; 1.5L, 14.04. S Short bowel syndrome, intractable malabsorption, pre-operative preparation of patients who are undernourished, IBD, total gastrectomy, bowel fistulae and disease related malnutrition. CAPD and haemodialysis. Q Under 5 years, caution. Under 1 year, unsuitable.
1O
ALSO FRESUBIN ENERGY FIBRE Protein (milk) 5.6g, fat (vegetable, MCT) 5.8g, carbohydrate (maltodextrin) 18.8g, fibre (inulin, wheat dextrin fibre, cellulose) 2g. Lactose and gluten free. Nutritionally complete. Oral- EasyBottle with straw 200ml (6 flavours) 1.5kcal/ml, A2.52.Liquid tube feed- 500ml EasyBag, A6.16; 1L, A12.32; 1.5L, See Fresubin 2250 Complete. S Short bowel syndrome, intractable FREBINI ENERGY Fresenius Kabi malabsorption, pre-operative preparation of patients who are undernourished, IBD, following 1O total gastrectomy, bowl fistulae and disease Oral/enteral nutritional. Protein (milk) 3.75g, carbohydrate (maltodextrin) 18.8g, fat (vegetable, related malnutrition. Q Under 5 years, caution. Under 1 year, MCT) 6.7g per 100ml. Lactose- and gluten- free. unsuitable. Nutritionally complete. Oral- Easy bottle with 1O straw 200ml (2 flavours) 1.5kcal/ml, A3.13. Liquid ALSO FRESUBIN ORIGINAL Protein (milk) 3.8g, tube feed- 500ml Easy Bag, A8.49. carbohydrate (maltodextrin) 13.8g, fat (vegetable, 1O ALSO FREBINI ENERGY FIBRE Protein (milk) 3.75g, MCT) 3.4g. lLactose and gluten free. Nutritionally carbohydrate (maltodextrin) 18.8g, fat (vegetable, complete. Oral- EasyBottle with straw 200ml (6 flavours) 1.0kcal/ml, A1.90. Liquid tube feedMCT) 6.7g, fibre 1.1g per 100ml Lactose- and 500ml EasyBag, A4.60; 1L, A9.21; 1.5L, A13.81. gluten- free. Nutritionally complete. Oral1O EasyBottle with straw 200ml (2 flavours) 1.5kcal/ ALSO FRESUBIN ORIGINAL FIBRE Protein (milk) ml, A3.20.Liquid tube feed- 500ml EasyBag, 3.8g, carbohydrate (maltodextrin) 13.8g, fat A9.09. (vegetable, MCT) 3.4g, fibre (inulin, wheat dextrin 1O fibre, cellulose) 1.5g,Gluten- and lactose-free. ALSO FREBINI ORIGINAL Protein (milk) 2.5g, carbohydrate (maltodextrin) 13.5g, fat (vegetable, Nutritionally complete. Liquid tube feed 500ml EasyBag, A5.57; 1L, A10.92; 1.5L, A15.72. MCT) 4g, fibre 1.1g per 100ml. lactose- and S Short bowel syndrome, intractable gluten- free. Nutritionally complete. Liquid tube malabsorption, pre-operative preparation of feed. Easybag 500ml, A7.22. patients who are undernourished, IBD, total 1O ALSO FREBINI ORIGINAL FIBRE Protein (milk) 2.5g, gastrectomy, bowl fistulae and disease related carbohydrate (maltodextrin) 12.5g, fat (vegetable malnutrition. Q Under 5 years, caution. Under 1 year, MCT) 4g, fibre 1.1g per 100ml. Lactose- and unsuitable. gluten- free. Nutritionally complete. Liquid tube 1O feed. Easybag 500ml, A7.52. ALSO FRESUBIN HP ENERGY Protein (milk) 7.5g, S Disease related malnutrition. Suitable carbohydrate (maltodextrin) 17g, fat (sunflower for children 1-10 years or 8-30kg. oil, MCT) 6g, vitamins, minerals, trace elements P Unsuitable. per 100ml, lactose-low (0.03%), gluten-free. Liquid Q Under 1 year or 8kg, unsuitable. tube feed (neutral flavour) 150kcal/100ml. FRESUBIN RANGE Fresenius Kabi Nutritionally complete. EasyBag tube feed 500ml, A5.79; 1L, A11.81. 1O S Short bowel syndrome, intractable FRESUBIN PROTEIN ENERGY. Oral nutritional. malabsorption, pre-operative preparation of Protein 10g, carbohydrate12.4g, fat 6.7g per patients who are undernourished, IBD, total 100ml. Lactose and gluten free. Liquid feed (5 flavours). 300kcal/200ml. Nutritionally complete for gastrectomy, bowl fistulae and disease related essential vitamins and trace elements in 2 x 200ml/ malnutrition. CAPD and haemodialysis. Q Under 5 years, caution. Under 1 year, day. EasyBottle with Straw 200ml, A2.07. unsuitable. S Disease related malnutrition, poor 1O appetite, poor wound healing, chronic wasting,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
245
10.6 FOODS
DIETETICS
ALSO FRESUBIN 1000 COMPLETE Protein (milk, soya) 5.5g, carbohydrate (maltodextrin) 12.5g, fat (vegetables oils, MCT) 3.1g, fibre (inulin, wheat dextrin fibre, cellulose) 2g, vitamins, minerals per 100ml, lactose- and gluten- free liquid feed. Liquid tube feed (neutral). 100kcal/100ml. Nutritionally complete. EasyBag tube feed 1L, A13.02. S Short bowel syndrome, intractable malabsorption, pre-operative preparation of patients who are undernourished, IBD, total gastrectomy, bowl fistulae and disease related malnutrition. Q Under 5 years, caution. Under 1 year, unsuitable.
nutrition or supplementary feed in children over 1 and adults. Q Children under 1 years, unsuitable.
GLUCERNA SR
Abbott
galactokinase deficiency, lactose intolerance.
INFATRINI
Nutricia
1O
ALSO FRESUBIN 1200 COMPLETE Protein (milk) 6g,carbohydrate (maltodextrin) 15g, fat (vegetable oil, fish oil) 4.1g, fibre (inulin,wheat dextrin fibre, cellulose) 2g, vitamins, minerals and trace elements per 100mls. Lactose and gluten free liquid tube feed.120kcal/100ml. Nutritionally complete. EasyBag 1L, A15.12. S As per Fresubin 1000 Complete. Q Under 5 years, caution. Under 1 year, unsuitable.
Oral/enteral nutrition. Protein 2.6g, carbohydrate 10.3g, fat 5.4g, prebiotics 0.8g, vitamins, minerals, trace elements per 100ml; gluten-free. 100kcal/ 100ml. Nutritionally complete. Glass bottle 100ml, A1.51 (non-GMS); plastic bottle 200ml, A2.65 (GMS); tube feed pack 500ml, A6.63 (GMS). S Disease related malnutrition, failure to thrive, increased energy requirements and/or fluid restrictions. 1O ALSO GLUCERNA Energy 98kcal. Protein 4.18g, fat Q Suitable for infants from birth to 12 months or up to 8kg body weight. 5.44g, carbohydrate 8.14g, fibre 1.44g per 100ml. Gluten- and clinically lactose-free. 1.0kcal/ml. ISOLEUCINE AA SUPPLEMENT Nutritionally complete. Oral: 250ml can Vitaflo (flavoured), A2.60. Enteral: Ready-to-hang-500ml, A5.20. 1O S Impaired glucose tolerance, type I and Oral nutritional. Isoleucine 50mg on carbohydrate type II diabetes mellitus and stress-induced base. Sachets. Not nutritionally complete. 30 x 4g, hyperglycaemia. A56.32. Q Under 2 years, not recommended. S Maple syrup urine disease. Under 6 years, use with caution. Q Under 12 months, not suitable.
1O
GLUTAFIN
1O
ALSO FRESUBIN 2250 COMPLETE Protein (milk) 5.6g, carbohydrate (maltodextrin) 18.8g, fat (vegetable, MCT) 5.8g. Fibre (inulin, wheat dextrin, cellulose) 2g. Lactose and gluten free. Nutritionally complete. Liquid tube feed 1.5L EasyBag, A15.72. S Short bowel syndrome, intractable malabsorption, pre-operative preparation of patients who are undernourished, IBD, following total gastrectomy, bowel fistulae and disease related malnutrition. Q Under 5 years, caution. Under 1 year, unsuitable.
GA GEL
1O
Oral/enteral nutritional. Energy 181kcal. Protein 9.30g, fat 6.76g, carbohydrate 22.2g, fibre 2.36g (of which FOS 0.84g) per 200ml. Gluten and clinically lactose-free. 0.94 kcal/ml. Nutritionally complete. 200ml pack with straw attached (2 flavours), A2.50.
Nutricia
1O
Enteral nutritional. Protein 4.0g, fat 3.47g, carbohydrate 14.1g, fibre 1.76g (of which FOS 0.7g) per 100ml. Gluten- and clinically lactose-free. 1kcal/ml. Nutritionally complete. Ready-to-hang 500ml, A5.60; 1L, A10.83; 1.5L, A16.24. S Conditions requiring long-term tube feeding, neuroligical disease, post CVA. Q Under 5 years, caution. Under 2 years, not recommended.
HCU EXPRESS
1O
Vitaflo
Oral nutritional. Essential/non-essential amino 1O acids, carbohydrates, minerals, trace elements, Oral nutritional. Powdered lysine free tryptophane vitamins and DHA. Methionine free. Sachets low protein substitute. 30 x 20g, A203.69. (unflavoured). Not nutritionally complete. 30 x S Glutaric aciduria type 1. 25g, A335.27. Q Suitable 12 months-10 years. S Proven homocystinuria. GALACTOMIN 17 SHS Q Under 8 years, not recommended.
1O
Oral nutritional. Protein (casein) 14.5%; fat (vegetable oils) 25.9%; carbohydrate (glucose) 54.9%, lactose-low (0.1%), sucrose-free; with vitamins, minerals, trace elements. Casein based, nutritionally complete formula containing minimal levels of lactose and galactose. See lit. Powder. 510kcal/100g. 400g, A17.26. S Galactosaemia, galactokinase deficiency, lactose intolerance.
Abbott
1O
Oral nutritional. Gluten-free products. White/fibre loaf (sliced)-400g, A2.82; white/fibre rolls (4 pk)280g, A3.66; high fibre seeded loaf-400g, A2.88. Part baked: White/fibre loaf (unsliced)-400g, A2.82; white/fibre rolls (4 pk)-400g, A4.46; long white/fibre rolls-280g (2 pk), A3.66. Fibre bread mix/fibre mix-500g-A3.55. Pasta (4 types)-500g, A4.64; pasta (2 types)-250g, A2.47. S Gluten-sensitive enteropathies.
Vitaflo 1 O
1O
JEVITY
ALSO HCU GEL Sachets (unflavoured). Not nutritionally complete. 30 x 20g, A199.23. Q Under 12 months, not recommended.
ALSO JEVITY PLUS Energy 120kcal. Protein 5.55g, fat 3.93g, carbohydrate 15.1g, fibre 2.2g (of which FOS 1.0g) per 100ml. Gluten- and clinically lactosefree. 1.2kcal/ml. Nutritionally complete. Ready-tohang -500ml, A6.35; 1L, A12.99); 1.5L, A19.49. S Conditions requiring long term tube feeding with increased needs, neurological disorders, rehabilitation. Q Under 10 years, caution. Under 2 years, not recommended.
1O
ALSO JEVITY 1.5KCAL Energy 152 kcal. Protein 6.38g, carbohydrate 20.1g, fat 4.9g, fibre 2.2g (of which FOS 1.0g) per 100ml. Gluten- and clinically ALSO HCU COOLER Liquid in foil pouches. Not lactose-free. 1.5kcal/ml. Nutritionally complete. nutritionally complete. 30 x 130ml, A371.59. Ready-to-hang-500ml, A6.59; 1L, A12.22; 1.5L, V Suitable for people aged 3 years and A19.07. above. S Conditions requiring long-term feeding with increased needs, impaired bowel function, HCU LV SHS neurological disorders. 1O 1 O Q Under 10 years, caution. Under 2 years, ALSO GALACTOMIN 19 FRUCTOSE FORMULA not recommended. Oral nutritional. Concentrated, low volume, Protein/casein 14.6%; carbohydrate 49.7%; fat/ 1O methionine-free formula. Sachets (2 flavours). vegetable oils 30.8%; with vitamins, minerals, 30x28g, A497.66. ALSO JEVITY PROMOTE Energy 101 kcal. Protein trace elements 534kcal/100g. Nutritionally S Homocystinuria in children over 8 years 5.55g, fat 3.32g, carbohydrate 12.0g, fibre 1.7g (of complete formula containing fructose, minimal and adults. which FOS 0.7g) per 100ml. Gluten- and clinically levels of lactose, glucose and galactose. 400g, lactose-free. Nutritionally complete in 1000ml. A45.45. INFASOY Cow & Gate Ready to hang-1L , A12.22. S Glucose with galactose intolerance. S Long term feeding for stroke, elderly, 1O GENERAID SHS Oral nutritional. Protein (soya, methionine) 15.4%, neurological disorders, post operative, weight maintenance. 1O carbohydrate (glucose syrup) 53%, fat (vegetable oils) 52%, vitamins and minerals (28.3%). Milk free Q Under 10 years, caution. Under 2 years, Whey protein (branched chain amino acids, not recommended. essential amino acids), carbohydrates, fat, vitamins, soya based protein formula. Suitable from birth minerals (low in Na+) and trace elements. Powder. and for lacto-vegetarians. 499Kcal/100g. JUVELA SHS Nutritionally complete. (OTC)900g, A9.52. 400g, A22.48. 1O S Hepatic disorders; as sole source of S Cowsâ&#x20AC;&#x2122; milk intolerance, galactosaemia,
246
1O
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS
FOODS 10.6
JUVELA GLUTEN FREE. Oral nutritional. Gluten free products. White/fibre loaf (sliced)-400g, A2.82; white/fibre rolls-5x85g-A4.88; fibre mix500g, A3.55.
1O ALSO JUVELA LOW PROTEIN Low phenylalanine products. Bread rolls-5x70g, A5.10; loaf-400g, A2.74, mix-500g, A8.70; cookies (variety)-125g, A6.49.
Oral nutritional. Essential and non-essential amino acids, carbohydrates, vitamins, minerals and trace elements. Low calorie, low volume, concentrated powdered phenylalanine free protein substitute in dose related sachets. 3 flavours. 30 x 27.8g, A297.61.
essential amino acids, carbohydrate, minerals, vitamins, trace elements. Phenylalanine-free. Powder 297kcals/100g (flavoured and unflavoured). 30 x 50g, A279.57; 500g, A93.19. S Phenylketonuria (patients over 8 years).
1O
ALSO XMET MAXAMUM Essential/non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. Methionine free. Unflavoured powder. 500g, A161.75. S Homocystinuria (patients aged over 8 years).
ALSO PKU LOPHLEX LQ Essential and nonessential amino acids, carbohydrates, vitamins, minerals and trace elements. Low calorie, low KETOCAL SHS volume, ready to drink phenylalanine free protein substitute. 4 flavours. PKU Lophlex LQ10 (10g 1O protein): 60 x 62.5ml, A327.61; PKU Lophlex LQ20 Oral nutritional. Milk protein with amino acids, (20g protein): 30 x 125ml, A327.61. vitamins, minerals and trace elements. High fat, S Phenylketonuria in children over 4 years low carbohydrate powder in 2 flavours. 300g, and adults. A30.86. Q Under 4 years, not suitable. S Used to administer classical ketogenic diet for epilepsy in children over 1 year and LOPROFIN SHS adults. 1O Q Infants under 1 year, unsuitable. Oral nutritional. Lactose-free, gluten-free, low KEYOMEGA Vitaflo phenylalanine, low protein products. Loaf (sliced)400g, A2.74; wafers-100g, A2.65; biscuits: Sweet1O 150g, A2.75; choc-125g, A2.75; cookies-100g, Oral nutritional. Powdered blend of arachidonic acid and decosahexanoic acid. Sachets of powder. A5.08; crackers (plain/herb): 150g, A3.75; crunch bar-8x41g, A16.15; duobar (variety) -8x45g, 30 x 4g, A40.95. A16.15; wafers (variety)-100g,A2.65; breakfast S Disorders where supplementation of cereal-375g, A8.49; part baked rolls/rolls-4 x 65g, AA/DHA is required. A4.06; PKU milk-200ml, 79c; snopro-200ml, A1.29; KINDERGEN SHS mix-500g A8.70; snack pots-47g, A4.80; rice- 500g, A9.06; vermacelli -250g, A4.52; egg replacer-2 x 1O 250g, A15.92; egg white replacer-100g, A10.26; Oral nutritional. Whey protein, carbohydrate, fat, pasta- 500g, A9.06; lasagna-250g A4.52. vitamins, minerals and trace elements with low S Phenylketonuria, other amino acid levels of K+, Cl, Ca++, phosphorus and vitamin A. abnormalities, renal and liver failure, liver Nutritionally complete powdered feed. 400g, cirrhosis. A29.85. S Chronic renal failure in infants and MAPLEFLEX SHS children. 1O P Unsuitable. Oral nutritional. Essential and non-essential amino LEUCINE AA SUPPLEMENT Vitaflo acids, carbohydrate, fat, vitamins, minerals and trace elements. Leucine-, isoleucine- and valine1O free. Protein 29g/100g. 390kcal/100g. 30x29g, Oral nutritional. Leucine 100mg on a carbohydrate A213.53. base. Sachets of powder. 30 x 4g, A60.78. S Maple syrup urine disease in children S Inborn errors of protein metabolism. aged 1-10 years.
LIQUIGEN
SHS
1O Oral nutritional Fat emulsion (50% MCT, 50% water) 450kcals/100ml. 250ml, A9.53. S Steatorrhoea associated with cystic fibrosis of the pancreas, intestinal lymphangiectasis, intestinal surgery, chronic liver disease, liver cirrhosis, other malabsorption syndromes, ketogenic diet in the management of epilepsy, Type 1 hyperlipoproteinaemia. B Introduce gradually into the diet over a period of days according to patient tolerance.
LOCASOL 1O
1O
1O ALSO MSUD MAXAMUM Essential/non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. Leucine, isoleucine and valine free powder (2 flavours). 500g, A161.75. S Maple syrup urine disease (patients aged over 8 years).
MAXIJUL SUPER SOLUBLE
SHS
1O Oral nutritional. Carbohydrate (glucose polymer) 95g per 100g. Low in electrolytes. Sucrose, lactose, fructose- and gluten-free. Powder. 380kcals/100g 200g-1, A2.62. Non GMS: 4x132g A7.49. S High energy, low fluid diet.
1O ALSO MAXIJUL LIQUID Carbohydrate (glucose) 50g. Liquid 200kcals/per 100mls (4 flavours). Not nutritionally complete. 200ml, A1.68. S Renal failure, liver cirrhosis, malabsorption, other conditions requiring high energy/low fluid diet.
MCT STEP 1
Vitaflo
1O
Oral nutritional. Nutritionally complete powdered feed, containing whole protein, carbohydrate, fat high in medium chain triglycerides and low in long chain triglycerides, vitamins, minerals, trace elements and essential fatty acids. Tin. 400g, A20.96. S Fat malabsorption, disorders of long chain fatty acid oxidation, Type 1 hyperlipidaemia and chylothorax. Q Suitable for infants and children under SHS 10 years of age.
1O XMET MAXAMAID. Oral nutritional. Essential/nonessential amino acids, carbohydrate, fat, vitamins, minerals, trace elements. Methionine free. Age range 2-8 years. 500g, A100.90. S Vitamin B6 non-responsive homocystinuria, hypermethioninaemia.
1O
ALSO XP MAXAMAID Essential/non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements. Phenylalanine-free. Powder SHS (flavoured and unflavoured) Age range 1-8 years. 500g, A60.30. S Phenylketonuria
Oral nutritional. Low Ca++ (max. 0.055%) synthetic food containing protein 14.6%, fat 26.1%, carbohydrate (lactose) 56.5%, vitamins and minerals, vit. D-trace. Low calcium (max. 0.055%) and vit.D synthetic food, casein based. Nutritionally complete. Powder. 508kcals/100g. 400g, A23.99. S Hypercalcaemia, conditions requiring calcium restriction.
LOPHLEX
MAXAMAID
1O
MCT DUOCAL
Nutricia
1O Oral nutritional. Powered supplement consisting of blend of carbohydrate and fat, high in medium chain triglycerides (MCT). 400g, A22.73. S Dietary management of conditions requiring extra calories from a combined fat and carbohydrate source, where there is fat malabsorption or where assimilation of LCTs is impaired. V Suitable for all ages, including infants.
MCT OIL
SHS
1O
1O
ALSO MSUD MAXAMAID Essential/non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements. Leucine, isoleucine, valine free. 309kcals/100g Age range 1-8 years-500g, A100.89. S Maple syrup urine disease.
Oral nutritional. Medium chain triglycerides. Glucose and lactose free. 500mls, A15.10. S Dietary management of fat malabsorption (e.g. cystic fibrosis, chronic live disease) or intractable epilepsy using the ketogenic diet.
MAXAMUM
MCT PEPDITE
SHS 1 O
XP MAXAMUM. Oral nutritional. Essential/non
SHS
SHS
1O Oral nutritional. Carbohydrate (maltodextrin) 59%,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
247
10.6 FOODS
DIETETICS
protein 10%, fat 14% (MCT 35%, LCT 65%) vitamins, minerals and trace elements. Amino acid based nutritionally complete hypoallergenic formula. 100kcal/100ml when reconstituted. Banana/vanilla 50g, A3.43; unflavoured 100g, A7.90. S Whole protein intolerance, food allergy, intractable malabsorption, inflammatory bowel disease, short bowel syndrome and bowel fistulae. MONOGEN SHS Can be used as a sole source of nutrition in 1O children age 1-10 years. ALSO MCT PEPDITE 1+ Carbohydrate 1O (maltodextrin) 59%, fat (83% MCT, 17% LCT) Oral nutritional. Whole whey protein, low in long NEPRO Abbott (sunflower, coconut oil) 18%, protein 13.8%, chain triglycerides (LCT) and high in medium chain vitamins, minerals, trace elements. Lactose, triglycerides (MCT). Nutritionally complete low fat 1 O sucrose, milk protein free powder. 453kcals/ Oral/enteral nutritional. 200kcal. Protein 7.0g, fat powdered feed. 400g A20.88. 100mls. Nutritionally complete for children 2 years S Lymphatic disorders such as 9.6g, carbohydrate 20.6g, fibre 1.56g (of which and older. 400g, A20.99. FOS 1.56g) per 100ml; gluten- and clinically hyperlipoproteinaemia type 1, intestinal S Whole protein intolerance, short bowel lymphangiectasia, chylothorax, intractable lactose-free. 2.0kcal/ml. Nutritionally complete. syndrome, intractable malabsorption, Oral: 200ml pack with straw attached (2 flavours), malabsorption with steatorrhea and post inflammatory bowel disease, bowel fistulae, fat A3.33, Enteral: Ready-to-Hang- 500ml, A7.64. operative feeding in short gut syndrome. As absorption difficulties. S Acute or chronic renal disease, renal complete nutritional support or supplement in failure and dialysis patients. infants and children. METABOLIC MINERAL MIXTURE Q Under 5 years, caution. Under 1, year SHS MSUD EXPRESS Vitaflo not recommended. fat (MCT 83%, LCT 17%) (sunflower, coconut oil) 18%, protein 13.8%, vitamins, minerals and trace elements. Lactose, sucrose, milk protein free. Powder. 1.845 MJ/100g or 453kcals/100g. Nutritionally complete for children 0-2 years. 400g, A20.99. S Severe GI tract impairment e.g. short bowel syndrome and/or fat malabsorption as in cystic fibrosis, lymphatic disorders, bowel fistula.
Oral nutritional. Protein 18g, carbohydrate 54g, fat 23g, vitamins, minerals per 100g, gluten- and lactose-free. Powder 500kcal/100g (unflavoured). Nutritionally complete. 400g, A15.43. S Active and remission phase of Crohnâ&#x20AC;&#x2122;s disease. Q Under 5 years, caution. Infants under 1 year, unsuitable.
1O
1O
Oral nutritional. Minerals and trace elements. Powder. 100g, A13.05. S Inborn errors of metabolism and other restrictive, therapeutic diets. Also as the mineral component of tube feeds.
Oral nutritional. Essential/non-essential amino acids, carbohydrates, minerals, trace elements, vitamins and DHA. Leucine, isoleucine and valine free. Sachets (unflavoured). Not nutritionally complete. 30 x 25g, A335.27.
1O
MINAPHLEX
SHS ALSO MSUD EXPRESS COOLER Liquid protein
1O
substitute. Foil pouches. 30 x 130ml, A366.59. S Maple syrup urine disease. Q Under 8 years, not recommended.
Oral nutritional. Essential and non-essential amino acids, carbohydrates, fat, vitamins, minerals and trace elements. Phenylalanine free drink in 3 flavours. 30x29g, A133.16. S Phenylketonuria in children aged 1-10 years. P Not suitable. Q Over 10 years, not suitable.
MSUD III
SHS
Nutricia
1O Thickening agent. Carbohydrate (modified maize starch) 90g per 100g; gluten and lactose free; powder. 360kcal/100g. Instant food and fluid thickener 9gx20, A 7.31; 225g, A5.81; 500g, A12.90. S Thickening of food and fluid in dysphagia. Q Under 3 years, unsuitable.
NUTRAMIGEN 1
Mead Johnson
1O
1O
Oral nutritional. Protein (casein, amino acids)14g, carbohydrate (glucose, corn starch) 55g, fat (vegetable oils) 25g, vitamins, minerals, trace elements. Lactose-, sucrose-, fructose- and glutenfree. Powder. 500kcal/100g. Nutritionally complete. 400g, A11.21. S Milk protein sensitivity, lactose SHS intolerance, galactosaemia, galactokinase deficiency.
Oral nutritional. Essential/non-essential amino acids, Ca++, phosphorus. Leucine, isoleucine and valine-free. Powder 326kcals/100ml. Not nutritionally complete. 500g, A200.11. Vitaflo S Maple syrup urine disease.
MMA/PA EXPRESS 1O
Oral nutritional. Methionine, threonine, valinefree and isoleucine low protein substitute. Powder. 25g-30, A349.13. S Methylmalonic acidaemia (MMA) and propionic acidaemia (PA). V Aged 8 years and above.
NEOCATE 1O
Oral nutritional. Protein 13%, carbohydrate (maltodextrin) 54%, fat (coconut oil, sunflower oil, canola oil, LCPs), minerals, vitamins and trace elements. Amino acid based nutritionally complete 1O hypoallergenic infant formula. Lactose-, sucroseALSO MMA/PA GEL Methionine, threonine, valine and gluten free. 70kcal/100ml when reconstituted. free and isoleucine low protein substitute 400g, A31.23. containing essential and non-essential amino acids, S Infants up to 1 year of age with whole carbohydrate, vitamins, minerals and trace protein intolerance including cowâ&#x20AC;&#x2122;s milk and other elements. Unflavoured powder in sachets. 20g-30, food allergy, short bowel syndrome, intractable A184.42 malabsorption, inflammatory bowel disease, bowel S MMA and PA. fistulae. Q Aged 12 months to 10 years. 1O
MODJUL FLAVOUR
SHS ALSO NEOCATE ACTIVE Carbohydrate 45.5%,
1O Flavouring agent. Flavouring, carbohydrate, saccharin, citric and malic acid. Powder. Varies (according to flavour) between 205-300kcals/100g. Orange, blackcurrant, pineapple 100g; cherry, vanilla, lemon/lime, grapefruit 20 x 5g, A12.51. S Use with unflavoured peptides/amino acid products. Q Under 6 months, unsuitable.
MODULEN IBD
Protein (amino acids) 11%, Fat 43.5% minerals, vitamins and trace elements with enhanced levels of iron, calcium and phosphate. Amino acid based hypoallergenic formula. 100kcal/100ml when reconstituted. 63g sachets, A5.13 (2 flavours: unflavoured and blackcurrant). S As a supplement to the diet for children aged 1-10 years with the following: Whole protein intolerance, food allergy, intractable malabsorption, inflammatory bowel disease, short bowel syndrome and bowel fistulae.
Nestle Clinical 1 O
1O
248
NUTILIS
ALSO NEOCATE ADVANCE Carbohydrates 58.4%,
1O ALSO NUTRAMIGEN 2 Protein (casein, amino acids) 15.8g, carbohydrate (glucose polymers, corn starch) 53g, fat (vegetable oils) 24g, vitamins, minerals, trace elements. Lactose-, sucrose-, fructose- and gluten-free. Powder. 490kcal/100g. Nutritionally complete. 400g, A11.21. S Disaccharide and/or whole protein intolerance for infants 6 months onwards. Q Under 6 months, not suitable.
NUTRINI
Nutricia
1O Enteral nutritional. Protein (caseinate) 2.75g, carbohydrate (maltodextrin) 12.3g, fat 4.4g per 100ml plus vitamins, minerals, trace elenents. Gluten and lactose free. 1kcal/ml. Nutritionally complete. 200ml glass bottle, A3.01; 500ml pack, A7.54. S Disease related malnutrition. Q Infants under 1 year, unsuitable.
1O ALSO NUTRINI ENERGY Protein (caseinate) 4.1g, carbohydrate (maltodextrin) 18.5g, fat 6.7g/100ml plus vitamins, minerals, trace elenents. Gluten and lactose free. 200ml glass bottle, A3.70; 500ml pack, A9.45.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
10.6 FOODS
DIETETICS
S Children with disease related malnutrition on a fluid restricted and/or with increased nutritional requirements. Q Infants under 1 year, unsuitable.
1O ALSO NUTRINI MULTI FIBRE Protein 2.75g, carbohydrate (maltodextrin) 12.3g, fat 4.4g, fibre (soy, arabic gum, starch, cellulose, inulin, oligofructose) 0.75g/100ml plus vitamins, minerals, trace elements. Gluten and lactose free. 1kcal/ml. 200ml glass bottle, A3.35; 500ml pack, A8.38. S Disease related malnutrition/impaired bowel function in children ages 1-6 years or 820kg body weight. Q Infants under 1 year, unsuitable.
NUTRISON RANGE
1O ALSO NUTRISON PROTEIN PLUS MULTI FIBRE Protein (caseinates) 6.3g, carbohydrate (maltodextrin) 14.1g, fat 4.9g, fibre 1.5g (soy polysaccharide, arabic gum, starch, inulin, cellulose, oligofructose) 1.5g/100ml plus vitamins, minerals, trace elements. Gluten- and lactosefree.1.25kcal/ml. 1L, A12.73. S Disease malnutrition combined with moderate stress.
Nutricia 1 O
1O NUTRISON STANDARD. Enteral nutritional. Protein 4g, carbohydrate 12.3g, fat 3.9g/100ml plus vitamins, minerals, trace elements. Gluten- and lactose-free. 1kcal/ml. 500ml, A5.41; 1L, A9.51; 1.5L, A14.25. S Disease related malnutrition, patients at risk of disease related malnutrition.
1O ALSO NUTRISON ENERGY Protein 6g, carbohydrate 18.5g, fat 5.8g/100ml plus vitamins, minerals and trace elements. Gluten- and lactosefree. 1.5kcal/ml. 500ml, A6.32; 1L, A11.62; 1.5L, A17.43. S Increased energy and protein requirements e.g. burns, sepsis, trauma, patients requiring fluid restriction or overnight feeding.
1O ALSO NUTRISON ENERGY MULTI FIBRE Protein (casein) 6g, carbohydrate (maltodextrin) 18.5g, fat 5.8g, fibre 1.5g (soy, arabic gum, starch, inulin, cellulose, oligofructose) 1.5g/100ml plus vitamins, minerals, trace elements. Gluten- and lactose-free. 1.5 kcal/ml. 500ml, A6.99; 1L, A12.92; 1.5L, A20.35. S Disease related malnutrition and impaired bowel function.
1O ALSO NUTRISON MULTIFIBRE Protein 4g, carbohydrate 12.3g, fat 3.9g, fibre (soy, arabic gum, resistant starch, cellulose, inulin, oligofructose) 1.5g/100ml plus vitamins, minerals, trace elements. Gluten- and lactose-free. 1kcal/ml. 500ml, A5.85; 1L, A10.60; 1.5L, A15.91. S Disease related malnutrition incl. impaired bowel function.
1O ALSO NUTRISON CONCENTRATED Protein 7.5g, carbohydrate 20.1g, fat 10g/100ml plus vitamins, minerals and trace elements. Gluten- and lactosefree. 2 kcal/ml. Concentrated energy dense. Nutritionally complete. 500ml, A10.15. S Disease related malnutrition and patients who require fluid restriction.
1O ALSO NUTRISON MCT Protein (whey, casein) 5g, carbohydrate 12.6g, fat 3.3g (MCT 2.3g)/100ml plus vitamins, minerals, trace elements. Glutenand lactose-low. 1kcal/ml (flavoured). 1L, A10.53. S Short bowel syndrome, intractable malabsorption, pre-operative preparation of undernourished patients. Inflammatory bowel disease, total gastrectomy. Dysphagia, bowel fistulae, anorexia nervosa. Neoplastic related cachexia.
1O ALSO NUTRISON PROTEIN PLUS Protein (casein)
250
6.3g, carbohydrate (maltodextrin) 14.2g, fat 4.9g/ 100ml plus vitamins, minerals, trace elements. Gluten- and lactose-free.1.25kcal/ml. 500ml, A5.43; 1L, A11.58. S Disease related malnutrition combined with moderate stress.
ALSO NUTRISON 1200 COMPLETE MULTI FIBRE Protein 5.5g, carbohydrate 15g, fat 4.3g, multi fibre 2g per 100ml plus vitamins, minerals and trace elements. Gluten- and lactose-free. 1.2kcal/ ml. 500ml, A6.40; 1L, A12.78; 1.5L, A18.65. S Long term feeding for critically ill, stroke, elderly, CVA, neurological disorders. D Infants under 1 year, unsuitable. B Children 1-6 years, caution.
acids, phenylalanine-free. 334kcals/100g. Suitable for all age ranges. 500g A148.34. S Phenylketonuria.
PAEDIASURE
Abbott
1O Oral/enteral nutritional (paediatric). Energy 202kcal. Protein 5.6g, fat 9.96g, carbohydrate 22.4g per 200ml. Gluten- and clinically lactosefree. 1.0kcal/ml. Nutritionally complete. Oral: 200ml pack with straw attached (4 flavours), A2.98. Enteral: Ready-to-Hang- 500ml (flavoured), A7.45. S Feed suitable for children 8-30kg (110years) for use in disease related malnutrition, failure to thrive, malignancy, pre and postoperative, trauma, poor appetite. P Not applicable. Q Under 1 year, not recommended.
1O
ALSO PAEDIASURE FIBRE Energy 200kcal. Protein 5.6g, fat 9.96g, carbohydrate 21.8g, fibre 01.46g (of which FOS 0.46g) per 200ml. Gluten- and clinically lactose-free. 1.0kcal/ml. Nutritionally complete. Oral: 200ml pack with straw attached (2 flavours), A3.30. Enteral: Ready-to-Hang -500ml A8.26. NUTRODRIP STANDARD Novartis (flavoured), S Feed suitable for children 8-30kg (11O 10years) for use in disease related malnutrition, failure to thrive, malignancy, pre and Oral nutritional. Protein 20.3g, fat 17.4g, postoperative, trauma with impaired bowel carbohydrate 70.4g per 500ml; lactose- and function. gluten-free. Nutritionally complete. Flexibag-15 x P Not applicable. 0.5L, A59.23; 6 x 1.5L, A71.00. S Existing malnutrition or those at risk of Q Under 1 year, not recommended. 1O malnutrition e.g. dysphagia, short bowel syndrome, intractable malabsorption, preoperative ALSO PAEDIASURE PLUS Energy 302kcal. Protein preparation of patients who are undernourished, 8.4g, fat 14.9g, carbohydrate 33.4g per 200ml. inflammatory bowel disease, total gastrectomy, Gluten and clinically lactose free. 1.5 kcal/ml. bowel fistulae, disease related to malnutrition. Nutritionally complete. Oral: 200ml pack with 1O straw attached (2 flavours), A3.65. Enteral: Readyto-Hang -500ml (flavoured), A9.32. ALSO NUTRODRIP ENERGY Protein 29g, fat 31g, S Feed suitable for children 8-30kg (1carbhydrate 100g with vitamins, minerals and 10years) for use in disease related malnutrition, trace elements per 500ml. 1.6kcal/ml. Nutritionally failure to thrive, malignancy, pre and complete. Flexibag-15 x 0.5L, A69.33. S When a high energy diet is required eg postoperative, trauma, fluid restriction and/or increased nutritional requirements. catabolic and burn patients, polytrauma sepsis, P Not applicable. postoperative complications, cancer, malnutrition Q Under 1year, not recommended. or patients requiring fluid retention.
OSMOLITE
1O Abbott ALSO PAEDIASURE PLUS FIBRE Energy 300kcal.
1O Enteral nutritional. Energy 101kcal. Protein 4.0g, fat 3.4g, carbohydrate 13.6g, per 100ml; glutenand clinically lactose-free. 1kcal/ml. Nutritionally complete. Ready-to hang- 500ml, A4.92; 1L, A9.51; 1.5L, A14.27. S Disease related malnutrition, GI intolerance or post parenteral nutrition. Q Under 5 years, caution. Under 1 year, not recommended.
1O ALSO OSMOLITE PLUS Energy 121kcal. Protein 5.55g, fat 3.93g, carbohydrate 15.8g per 100ml; gluten- and clinically lactose-free. 1.2kcal/ml. Nutritionally complete. Ready-to-hang- 500ml, A5.92 1L, A11.43; 1.5L, A17.13. S Disease related malnutrition with increased needs, neurological disease. Q Under 10 years, caution. Infants under 1 years, not recommended.
Protein 8.4g, fat 14.9g, carbohydrate 32.8g, fibre 2.2g (of which FOS; 0.7g) per 200ml. Gluten and clinically lactose free. 1.5 kcal/ml. Nutritionally complete. Oral: 200ml pack with straw attached (1 flavour), A3.64. Enteral: Ready-to-Hang -500ml (flavoured), A9.92. S Feed suitable for children 8-30kg (110years) for use in disease related malnutrition, failure to thrive, malignancy, pre and postoperative, trauma with impaired bowel function, fluid restriction and/or increased nutritional requirements. P Not applicable. Q Under 1 year, not recommended.
PEPDITE
SHS
1O
Oral nutritional (infant). Low molecular weight peptides (non-milk derived), essential amino acids, carbohydrates, fat, vitamins, minerals and trace elements. Nutritionally complete powder. 400g, P.K. AID 4 SHS A19.29. 1O S Infants with severe impairment of the Oral nutritional. Essential and non-essential amino gastrointestinal tract e.g. malabsorption, bowel
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIETETICS
FOODS 10.6
fistulae, short bowel syndrome, protracted diarrhoea.
1O
PERATIVE
Abbott
1O
Enteral nutritional. Energy 131kcal. Protein 6.7g, fat 3.7g, carbohydrate 17.7g per 100ml. Glutenand clinically lactose-free. 1.3kcal/ml. Nutritionally complete. Ready-to-hang- 500ml, A8.51; 1L, A17.02. S Disease related malnutrition, short bowel syndrome, intractable malabsorption, total gastrectomy, bowel fistulae, dysphagia, inflammatory bowel disease, pre-operative preparation of malnourished patients, gastroenteritis. Q Under 5 years, caution. Under 1 year, Nestle Clinical not recommended.
ALSO PEPDITE 1+ Low molecular weight peptides (non-milk derived), essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements. Nutritionally complete powder. 15x57g, A50.61; banana flavour. 400g, A20.26; unflavoured. S Severe gastrointestinal tract impairment requiring a semi-elemental diet e.g. crohn’s disease, malabsorption, bowel fistulae or short bowel syndrome in children over 1 year. Q Children under 1 year, not suitable.
PEPTAMEN 1O
Oral nutritional. Protein 4g, carbohydrate 12.7g, fat 3.7g, vitamins, minerals per 100ml, gluten- and lactose-free. Liquid 100kcal/100ml (flavoured and unflavoured). Nutritionally complete. Flavoured-4 x 200ml, A14.52; Unflavoured-375ml, A5.96; Dripac-flex- 500ml, A7.38. S Acute inflammatory bowel disease, intractable malabsorption, pancreatic insufficiency, radiation enteropathy, short bowel syndrome. Q Under 5 years, caution. Infants under 1 year, unsuitable.
PEPTI FIRST
Cow & Gate
1O Oral nutritional. Whey protein (85% short chain peptides, 15% free amino acids), fat (100% LCT, vegetable oils), carbohydrate (38% lactose, 62% glucose syrup), vitamins, minerals. Whole milk protein- and soya-free. Nutritionally complete. Suitable from 0-6 months. 450g, A9.09. S Cows’ milk protein allergy. Soya allergy.
PHLEXY 10
SHS
1O Oral nutritional. Essential and non-essential amino acids, phenylalanine free. 69kcals/20g sachet (2 flavours); tabs. or caps. Sachet-30 x 20g, A133.07; caps.-200, A44.15; tabs.-75, A29.18. S Phenylketonuria. Q Under 1 year, unsuitable. Tabs.- under 8 years, unsuitable.
1O ALSO PHLEXY VITS Vitamins, minerals, trace elements. 3kcals/100g. 30 x 7g, A76.98; 180, A108.60. S Restrictive therapeutic diets e.g.phenylketonuria in older children and adults.
PK MAX
A209.55. S For the dietary management of phenylketonuria. Q Under 8 years, not recommended.
1O ALSO PKU START A ready to feed phenylalanine free infant formula. 6 x 500ml bottles, A43.88. Q Infants from diagnosis to 12 months of age.
1O ALSO PKU GEL Sachets (2 flavours, 1 unflavoured). 30 x 20g, A116.21. S Phenylketonuria in children. Q Recommended only: 6 months-10 years (unflavoured) or 12 months-10 years (flavoured).
POLYCAL
Nutricia
1O Oral nutritional. Maltodextrin 61.5%. 250kcal/ 100ml ready to use high energy carbohydrate based drink, lactose, galactose, sucrose, gluten, protein free, low electrolyte (1 flavour and neutral). Not nutritionally complete. 200ml, A1.68. S Renal failure, liver cirrhosis, disaccharide intolerance (without isomaltose intolerance), hypoglycaemia, amino acid metabolism disorders and protein intolerance, malabsorption states, conditions requiring a high energy, low fluid intake.
PREGESTIMIL
Mead Johnson
1O
SHS Oral nutritional. Protein (casein, amino acids) 14g,
1O
Oral nutritional. Essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. 292kcals/100g (3 flavours). 30x19g, A144.72. 1O S Phenylketonuria in children aged 1-10 ALSO PEPTI FOLLOW ON Whey protein (8% shortyears. chain peptides, 15% free amino acids), fat (100% LCT, vegetable oils), carbohydrate (38% lactose, PKU ANAMIX JUNIOR LQ SHS 62% glucose syrup), vitamins, minerals. Whole milk protein- and soya-free. Iron enriched follow- 1 on formula. Use as part of mixed diet from 6 Oral nutritional. Liquid phenylalanine free protein months. 450g, A7.83. substitute containing essential and non essential amino acids, carbohydrates, fat, vitamins, minerals S Cows’ milk protein allergy/soya allergy and trace elements in 2 flavours. 36 x 125mls, in older infants, children and adults. A208. PEPTI-JUNIOR Cow & Gate S Phenylketonuria in children aged 110years. 1O P Not Suitable Oral nutritional. Protein (whey 80%, short chain Q Over 10 years, not suitable peptide 20%, free amino acids), carbohydrate (q99% glucose syrup), fat (50% MCT, 50% LCT), PKU COOLER SYSTEM Vitaflo vitamins, minerals, clinically insignificant lactose. 1O 450g, A13.05. S Multiple/severe food intolerance, short Oral nutritional. Liquid phenylalanine free protein bowel syndrome, cystic fibrosis, inflammatory substitute containing essential and non-essential bowel disease, severe protein-energy malnutrition, amino acids, carbohydrate, vitamins, minerals trace pre- and post-operative nutrition. elements and DHA. Foil pouches (4 options). PKU cooler10 (protein 10g): 30 x 87ml, A149.19. PKU PEPTISORB Nutricia cooler15 (protein 15g): 30 x 130ml, A222.22. PKU cooler20 (protein 20g): 30 x 174ml, A298.38. 1O Enteral Nutritional. Protein 4g (whey hydrolysate), S For the dietary management of phenylketonuria in children over 3 years. carbohydrate (17.6g), fat 1.7g (MCT 0.8g)/100ml plus vitamins, minerals and trace elements. Gluten Q PKU Cooler20 not recommended under 8 years due to its volume. A free and low-lactose. 1 kcal/ml. 500ml, 8.08; 1L, A14.86. PKU RANGE Vitaflo S Intractable malabsorption, short bowel 1O syndrome, inflammatory bowel disease, bowel fistualae, disease related malnutrition. PKU EXPRESS POWDER. Oral nutritional. Essential/ D Infants under 1 year of age. non-essential amino acids, carbohydrates, minerals, Galactosaemia. trace elements and vitamins. Phenylalanine free. B Children aged 1-6 years. Sachets (4 flavours, 1 unflavoured). 30 x 25g,
carbohydrates (glucose, corn starch) 51g, fat (medium chain triglycerides, vegetable oils) 28g, vitamins, minerals, trace elements. Lactose-, sucrose-, fructose- and gluten-free. Powder 500kcal/100g. Nutritionally complete. 400g, A12.80. S Galactosaemia, galactokinase deficiency, sucrose and/or lactose intolerance with protein intolerance. Impaired fat absorption, with/without protein intolerance.
PRO-CAL POWDER
Vitaflo
1O Oral nutritional. Protein (casein) 13.5g, carbohydrate (lactose) 26.8g, fat (vegetable) 56.2g per 100g. Powder 667kcal/100g. Not nutritionally complete. 510g, A15.49.
1O ALSO PRO-CAL SHOT Protein (casein) 6.7g, carbohydrate (lactose) 13.4g, fat (vegetable) 28.2g per 100ml. Creamy white liquid 334kcal/100ml. Available in neutral, strawberry or banana flavours. Not nutritionally complete. 6 x 250ml, A35.55. S Disease related malnutrition, malabsorption states, other conditions requiring fortification with energy and protein. Q Infants under 1 year, unsuitable. Strawberry and banana flavour unsuitable under 3 years.
PROMIN
Firstplay
1O Oral nutritional. Essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements. Low protein products. Rice pudding mix (4 flavours)-4 x 69g, A7.31; pasta (6 types)-500g, A8.57; pasta imitation rice-500g, A8.57; pasta tri-colour (3 types)-500g, A8.57; low protein & GF cous cous -500g, A8.23; pasta in
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
251
10.6 FOODS
DIETETICS
sauce (2 flavours) - 4 x 72g, A9.11; burger mix-2 x 62g, A7.31.
1O ALSO PROMIN LOW PROTEIN Essential and nonessential amino acids, carbohydrate, fat, vitamins, minerals and trace elements. Low protein products. Hot breakfast (4 flavours)-6 x 57g, A9.11; low protein & GF lasagne sheets-200g, A3.53. S Inherited metabolic disorders, renal or liver failure requiring a low-protein diet including phenylketonuria.
RENILON 7.5
Nutricia
1O Oral nutritional. Protein 7.5g, fat 10g, carbohydrate 20g per 100ml. Gluten and fibre free. 2kcal/ml. Tetra (2 flavours)-125ml, A2.55. S Energy dense, low volume, low electrolyte feed for patients with renal disease requiring dialysis. Q 3-6 years, caution. Under 3 years, not suitable.
RESOURCE THICKEN UP
1O Oral nutritional. Low protein, low phenylalanine drink based on milk extracts. 67kcals/100ml. 200ml, A1.29. S Milk substitute where necessary to restrict protein intake, particularly for inborn errors of amino acid metabolism e.g. phenylketonuria.
SUPLENA
Abbott
1O
Novartis Oral/enteral nutritional. Energy 200kcal. Protein
3.0g, fat 9.6g, carbohydrate 25.5g per 100ml. Gluten- and clinically lactose-free. 2kcal/ml. Nutritionally complete. 237ml can (1 flavour), 1O A3.62. Oral/enteral nutritional. Energy 125kcal. Protein S Acute or chronic renal failure (without 6.65g, fat 2.56g, carbohydrate 18.3g, fibre 2.07g dialysis), acute and chronic liver disease or any (of which FOS 1.1g), per 100ml. Gluten- and condition requiring a high protein, low electrolyte, clinically lactose-free. 1.25kcal/ml. Nutritionally RESPIFOR Nutricia high calorie supplement. complete. Oral: 240ml pack with straw attached (2 1O Q Under 5 years, caution. Under 1 year, flavours), A4.29. Enteral: Ready-to-Hang Oral nutritional. Protein 7.5g, carbohydrate 22.5g, not unsuitable. (flavoured) -500ml, A.8.94. fat 3.3g per 100ml. Gluten free. 1.5kcal/ml. Tetra S Dietary management of cancer induced SURVIMED OPD Fresenius Kabi (3 flavours)-125ml, A2.55. weight loss. S High protein and carbohydrate, low fat 1 O Q Under 4 years, caution. Under 1 year, feed for patients with respiratory disease/ Oral nutritional. Protein (amino acids, not recommended. insufficiency. oligopeptides) 4.5g, carbohydrate (maltodextrin, Q 3-6 years, caution. Under 3 years, not starch) 15g, fat (MCT, soya oil) 2.4g, minerals, PROTIFAR Nutricia suitable. vitamins, trace elements per 100ml, lactose-free. 1O Liquid tube feed, 100kcal/100ml. Nutritionally SANDOSOURCE GI CONTROL Oral nutritional. Protein 88.5%. Powder 370kcal/ complete. Bottle-500ml, A7.70; EasyBag-500ml, 100g. 225g, A9.67. Novartis A7.70. S Hypoproteinaemia, high protein S Short bowel syndrome, intractable 1 requirements e.g. impaired wound healing. malabsorption, pre-operative preparation of Oral/enteral nutritional. Protein 20.5g, fat 17.5g, undernourished patients, inflammatory bowel carbhydrate 72g, soluble fibre 10.8g (Benefiber), PROVIDE XTRA Fresenius Kabi disease, total gastrectomy, bowel fistulae and vitamins, minerals, trace elements per 500ml. disease related malnutrition. 1O A A Flexibag-15 x 0.5L, 87.99; 6 x 1.5L, 105.67. Oral nutritional. Protein (soya, pea) S Gut mucosal growth and support in the Q Under 5 years, caution. Infants under 1 treatment of diarrhoea, long term enteral feeding. year, unsuitable. 3.75g,carbohydrate (sucrose, maltodextrin) 27.5g. Nutritionally complete for vitamins and trace Nutricia SCANDISHAKE MIX Nutricia TENTRINI RANGE elements in 2 x 200ml/day. Gluten, lactose, milk 1O and fat free. Oral- EasyBottle with straw 200ml (8 1 O sweet flavours, 1 savoury) 1.5kcal/ml A2.42. Oral nutritional. Protein 4g, carbohydrate 58g, fat TENTRINI. Enteral nutritional. Protein 3.3g, S Short bowel syndrome, intractable carbohydrate 12.3g, fat 4.2g per 100ml plus 21g, vitamins, minerals per 85g (one serving). malabsorbtion, pre-operative preparation of 437kcals/89g sachet (5 flavours, 1 unflavoured). 6, vitamins, minerals, trace elements. Gluten-, undernourished patients, inflammatory bowel lactose-free. 1kcal/ml. 500ml, A6.35. A17.61. disease, total gastrectomy, bowl fistulae, disease S Increased energy requirements e.g. post- 1 O related malnutrition. ALSO TENTRINI ENERGY Protein 4.9g, op, oncology, cystic fibrosis. Q Under 5 years, caution. Infants under 1 P Mix sachet with 240ml whole milk. carbohydrate 18.5g, fat 6.3g per 100ml plus year, unsuitable. vitamins, minerals, trace elements. Gluten-, Q Under 5 years, half sachet mixed with lactose-free. 1.5kcal/ml. 500ml, A7.86. 240ml milk.
PROSURE
Abbott 1 O
PULMOCARE
Abbott
Thickening agent. Instant food thickener with vitamins and minerals (neutral). Tin-12 x 227g, A68.26. S Thickening of foods in dysphagia.
1O Enteral nutritional. Energy 151kcal. Protein 6.25g, fat 9.33g, carbohydrate 10.6g per 100ml. Glutenand clinically lactose-free. 1.5kcal/ml. Nutritionally complete. Ready-to-hang, 500ml, A7.47. S Patients with pulmonary disease, respiratory failure, acute and chronic bronchitis, emphysema, malnourished patients requiring oxygen therapy. Q Under 6 years not recommended.
SMA HIGH ENERGY
1O SMA ALSO TENTRINI MULTI FIBRE As for Tentrini with
1O
Oral nutritional. Protein (skimmed milk, reduced minerals whey) 2g, carbohydrate (lactose) 9.8g, fat (vegetable oils) 4.9g, vitamins, minerals, trace elements per 100ml; gluten-free. Liquid milk formula feed. 91 kcal/100ml. Nutritionally complete. Tetrapak-12 x 250ml, A29.86. Bottles100ml (hospitals only). S Disease related malnutrition, growth failure, malabsorption. Vitaflo Q Suitable for children aged 0-18 months.
QUICKCAL
1.1g multi fibre per 100ml. Gluten-, lactose-free. 1kcal/ml. 500ml, A6.95.
1O ALSO TENTRINI ENERGY MULTI FIBRE As for Tentrini Energy with 1.1g multi fibre/100ml. Gluten-, lactose-free. 1.5kcal/ml. 500ml, A8.64. S Disease related malnutrition for children 7-12 years (or 21-45kg). D Infants under 1year.
THICK & EASY
Fresenius Kabi
1O
1O
1O
Oral nutritional. Protein (casein) 4.6g, carbohydrate (lactose) 17g, fat (vegetable) 77g per 100g. Powder 780kcal/100g. Not nutritionally complete. 25 x 13g, A15.08. S Disease-related malnutrition, malabsorption states, other conditions requiring fortification with a fat, carbohydrate supplement. Q Infants under 1 year, not recommended.
ALSO SMA LF Protein (whey, casein) 12g, carbohydrate (glucose) 55.6g, fat (vegetable oils) 27g, vitamins, minerals, trace elements per 100g. Gluten-free, lactose-low. Powder 5.5kcal/100g. Nutritionally complete. 430g, A5.73. S Lactose intolerance.
Thickening agent. Carbohydrate (modified maize starch, maltodextrin) 90g/100g, gluten-free. Powder 360kcal/100g. 100 x 9g sachet, A40.35; Tin-225g, A6.33. S Thickening of foods in dysphagia. Q Not suitable for children under 3 years.
SNO PRO
TYR RANGE
252
SHS
Vitaflo
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY
BRONCHODILATORS, OTHER
1O TYR EXPRESS. Oral nutritional. A powdered tyrosine and phenylalanine free protein substitute with DHA. Unflavoured powder. 30 x 25g, A349.13. S Tyrosinaemia. V Suitable for people aged 8 years and above.
1O ALSO TYR GEL Unflavoured powder. 30 x 20g, A195.10. Q Suitable for children aged 12 months to 10 years.
1O ALSO TYR COOLER Drink liquid in foil pouches. 30 x 130ml, A371.59. V Suitable for people aged 3 years and above.
TYROSINE AA SUPPLEMENTVitaflo 1O Oral nutritional. L-Tyrosine 1g on a carbohydrate base. Sachets of powder. 30 x 4g, A58.23. S Inborn errors of protein metabolism. Q From 12 months of age.
VALINE AA SUPPLEMENT
Vitaflo
1O Oral nutritional. Valine 50mg on carbohydrate base. Sachets. Not nutritionally complete. 30 x 4g, A56.32. S Maple syrup urine disease. Q Under 12 months, not suitable.
VITABITE
Vitaflo
1O Oral nutritional. Lactose, hydrogenated vegetable oil, sucrose, carob flour, lecithin. Chocolate flavoured bar. Not nutritionally complete. 7 x 25g, A8.26. S Protein restricted diet. Q Under 1 year, not recommended.
VITAJOULE
Vitaflo
1O Oral nutritional. Carbohydrate 95g per 100g. 384kcal/100g. Not nutritionally complete. Neutraltasting carbohydrate powder supplement. 500g, A4.42. S Disease related malnutrition, malabsorption states, other conditions requiring fortification with energy and as a carbohydrate source in modular feeds. V Determine dose based on patient’s age, body weight and medical condition. Sprinkle onto hot or cold food or drink. Add 1-2 scoops per serving. B Caution: Diabetes mellitus.
ANTI-ASTHMATICS
11.1
Selective b2-agonist. Salbutamol (sulph.) 100mcg/ dose. Breath-actuated metered dose aerosol. 200dose unit-1, A7.55. Oral nutritional. Protein (soya, L-methionine) 16%, S Treatment of reversible airways carbohydrate (corn syrup, sucrose) 52%, fat (oleic, obstruction. Prophylaxis of exercise-induced soya, coconut oil) 27%, vitamins, minerals, trace asthma. elements. Milk protein-, lactose- and gluten-free. V Reversible airways obstruction: 100mcg Powder. 2.11MJ/100g. Nutritionally complete. increasing to 200mcg as a single dose if necessary. (GMS) 430g, A4.76; (OTC) 860g, A9.96. Exercise induced asthma: 100mcg increasing to S Milk or lactose intolerance, 200mcg before exercise. Max. 8 puffs in 24 hours. galactosaemia, galactokinase deficiency. B Thyrotoxicosis, angina, severe tachycardia. Pregnancy, lactation. XMET HOMIDON SHS C Non-selective b-blockers, anaesthetics. A Fine tremor, headache, palpitations, 1O Oral nutritional. Essential and non-essential amino tachycardia, hypokalaemia, paradoxical bronchospasm. Hypersensitivity and hyperactivity acids, taurine and carnitine. Methionine-free. in children. White powder. Protein 77g/100g. 326kcal/100g. 500g A200.10. AIROMIR Teva S Dietary management of vitamin B6 nonresponsive homocystinuria or 9MO hypermethioninaemia. Selective b2-agonist. Salbutamol (sulph.) 100mcg/ dose. CFC-free metered dose aerosol. 200-dose ZAVESCA Actelion unit-1, A2.48. S Acute attacks of bronchial asthma. 2MT Treatment of reversible airways obstruction. Enzyme inhibitor. Miglustat 100mg. White cap. Prophylactic use before exercise-induced asthma. with OGT 918 printed on the cap and 100 on the V Acute bronchospasm: 1-2 puffs. body. 84, A6767. Prophylaxis: 1-2 puffs before exercise. Max. 8 puffs S Mild to moderate type 1 Gaucher in 24 hours. disease. B Hyperthyroidism. Myocardial P 100mg three times a day. 100mg once or twice a day may be necessary in some patients insufficiency, angina, cardiac arrhythmia, because of diarrhoea. Renal impairment: cc 50- hypertension. Pregnancy, lactation. C Sympathomimetics, b-blockers. 70ml/min, 100mg twice daily; cc 30-50ml/min, A Fine tremor, headache, tachycardia, 100mg/day. palpitations, hypokalaemia, paradoxical R Over 70 years, no experience. bronchospasm, hypersensitivity, angiodema. Q Under 18 years, not recommended. B Severe Gaucher disease, no data. ALUPENT Boehringer Ing. Monitor vitamin B12 level regularly. Perform baseline and repeat neurological evaluation and 5MO assessment of cognitive functions. Male and Partially selective b-agonist. Orciprenaline (sulph.) female patients should use adequate 10mg/5ml. Sugar-free. 300ml, A2.95. contraception. Pregnancy, lactation. Caution: S Bronchospasm in chronic bronchitis, Renal/hepatic impairment. Severe renal asthma, emphysema. impairment, not recommended. P 10ml four times daily. C Cerezyme. Q Up to 1 year, 2.5-5ml three times daily. A Weight loss/increase, decreased 1-3 years 2.5-5ml four times daily. 3-12 years, 5ml appetite, tremor, dizziness, headache, leg cramps, four times daily to 10ml three times daily. paraesthesia, peripheral neuropathy, cognitive D Acute coronary disease, dysfunction, visual disturbance, GI disorders. hyperthyroidism, cardiac asthma. Hypertension, diabetes. 11.1 BRONCHODILATORS, OTHER ANTI- B C MAOIs, tricyclics, sympathomimetics. ASTHMATICS A Arrhythmias, fine tremor, nervous tension, headache, peripheral vasodilatation, ACCOLATE AstraZeneca tachycardia.
WYSOY
Wyeth
1O
2MO
Leukotriene receptor antagonist. Zafirlukast 20mg. White/off-white tab. 56, A23.98. S Prophylaxis and chronic treatment of asthma. 1st-line maintenance therapy in patients requiring more than prn. bronchodilator. VITAPRO Vitaflo P Initial dose 20mg twice daily. Usual maintenance dose 20mg twice daily; max. 40mg 1O Oral nutritonal. Whey protein. Powder. 225g tub, twice daily. Q Under 12 years, not recommended. Over A9.67. 12 years, same as adults. S Hypoproteinaemia. B Not evaluated in brittle/unstable VITAQUICK Vitaflo asthma. Pregnancy, lactation. A Headache, GI disturbance, elevated 1O serum transaminases. Increased incidence of mild Thickening agent. Carbohydrate (modified maize) infection in elderly. 95g, Na+ 5mmol, K+ 0.01mmol, protein and fat traces only. Powder 400kcal/100g. Not nutritionally AEROLIN AUTOHALER CFC-FREE complete. 10 x 300g, A86.40. Teva S Dietary management of dysphagia. 9MO Q Under 1 year, not recommended.
ALVESCO
Nycomed
4NO Corticosteroid. Ciclesonide 80mcg, 160mcg per actuation. Pressurised inhalation. 80mcg-60 puffs, A17.99; 160mcg-60 puffs, A21.20. S To control persistent asthma in adults and adolescents. P 160mcg once daily (also max. dose), preferably in the evening. May be reduced to 80mcg once daily as effective maintenance dose. Symptoms start to improve within 24 hrs. Q Under 12 years, not recommended. B Assess patients with severe asthma regularly. Seek medical advice and consider increased anti-inflammatory therapy if asthma control not improved or more inhalations required. Caution: Active / quiescent pulmonary tuberculosis, infections. Severe hepatic impairment; monitor for systemic effects. Transfer
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
253
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
from systemic steroids; caution. Not indicated in status asthmaticus. Possible systemic effects include adrenal suppression, growth retardation, decreased BMD, cataract, glaucoma. Monitor childrens/adolescents height regularly. Pregnancy, lactation (only if benefit outweighs risk). C Caution: Potent CYP3A4 inhibitors. A Paradoxical bronchospasm.
ASMABEC CLICKHALER
UCB
4MO Corticosteroid. Beclomethasone dipropionate 50mcg, 100mcg, 250mcg per dose. Dry powder breath-actuated inhaler. 50mcg-200 dose unit, A9.45; 100mcg-200 dose unit, A13.88; 250mcg-100 dose unit, A17.42. S Control of persistant asthma. P 200mcg twice daily or 100mcg four times daily, increasing to 800mcg daily in two, three or four divided doses. Severe cases, 500mcg twice daily or 250mcg four times daily increasing if necessary to 1.5-2mg daily. Q Under 6 years, not recommended. 6-12 years, 50-100mcg two to four times daily (not Asmabec Clickhaler 250). B Active or quiescent pulmonary tuberculosis. Pregnancy. Transferring from systemic steroids. A Hoarseness, mouth and throatcandidosis. Systemic effects, particularly with high doses for prolonged periods. Paradoxical bronchospasm.
ASMANEX TWISTHALER
phaeochromocytoma. Pregnancy. C Sympathomimetics, b-blockers, xanthines, steroids, diuretics, anaesthetics, cardiac glycosides. A Mild tremor, nervous tension, headache, peripheral vasodilation, hypokalaemia, palpitations, muscle cramps, oropharyngeal irritation, hypersensitivity reaction, paradoxical bronchospasm.
ATROVENT INHALER CFC-FREE Boehringer Ing.
2MO Anticholinergic. Ipratropium bromide 20mcg/dose. Metered dose inhaler. 200-dose unit, A4.94. S Bronchospasm in COPD (chronic bronchitis, emphysema) and asthma. P 1 or 2 puffs three or four times daily. Max. 4 puffs at a time. Q Under 6 years, 1 puff. 6-12 years, 1 or 2 puffs. Both 3 times daily.
2MO ALSO ATROVENT UDVS 1ML Ipratropium bromide 0.025% (250mcg/ml). Unit dose vials (UDVs) preservative free. 1ml vial-20, A2.86; 60, A10.62.
2MO ALSO ATROVENT UDVS 2ML Ipratropium bromide 0.025% (250mcg/ml). Unit dose vials (UDVs) preservative free. 2ml vials-20, A3.40; 60, A12.56.
ScheringPlough
4NO Corticosteroid. Mometasone furoate 200mcg, 400mcg. Metered inhalation powder. 200mcg-30, A21.98; 60, A32.97; 400mcg-30, A30.50; 60, A50.49. S Regular treatment to control persistent asthma. P Initially 400mcg once daily in the evening or 200mcg twice daily. Maintenance dose may be reduced to 200mcg once daily. Severe asthma, 400mcg twice daily max. Q Under 12 years, not recommended. B Oral candidiasis may occur. Caution when transferring patients from systemic steroids. Tuberculosis infections of respiratory tract, untreated fungal, bacterial, systemic viral infections, ocular herpes simplex. Pregnancy, lactation. C Ketoconazole. A Candidiasis, dysphonia, pharyngitis, headache.
ASMASAL CLICKHALER
UCB
9MO Selective b2-agonist. Salbutamol (sulph.) 95mcg per dose. Dry powder breath-actuated inhaler. 200dose unit, A7.56. S Treatment of bronchospasm in bronchial asthma, reversible airways obstruction. P Acute attack, 1 or 2 puffs as necessary. Allergic or exercise-induced asthma, 2 puffs 15 mins. before challenge. On demand, max. 2 puffs four times daily. Q Acute attack or before exercise, 1 puff as necessary. If response is inadequate, higher doses can be used.On demand, max. 1 puff four times daily. B Hyperthyroidism, diabetes, severe cardiovascular disorders, hypertension,
254
RESPIRATORY P 500mcg 3-4 times daily. Q Up to 12 years, 250mcg up to 4 times daily. Under 6 years, under medical supervision only. B Narrow-angle glaucoma, prostatic hyperplasia, bladder-outflow obstruction, CF. Pregnancy, lactation. C Caution: b-adrenergic drugs, xanthine preparations. A Headache, nausea, dryness of the mouth.
BABYHALER
A&H
O Licensed for use with Ventolin Inhaler and Becotide 50mcg and 100mcg Inhalers. Large volume spacer device (350ml) for babies and very young children aged 1 year and older with asthma, (with face mask and 2 spare valves). 1, A14.46.
BECLAZONE EASI-BREATHE
Teva
4MO Corticosteroid. Beclometasone dipropionate 50mcg, 100, 200, 250mcg per dose. Breathactuated aerosol CFC-free. 50mcg-200 dose unit, A5.31; 100mcg-200 dose unit, A10.34; 200mcg-200 dose unit, A20.05; 250mcg-200 dose unit, A22.09.
4MO
PRESCRIBING NOTES COPD Definition: Disease characterised by airflow limitation, not fully reversible, usually progressive, associated with abnormal lung inflammatory response to noxious particles/gases. (The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, revised 2003). Diagnosis: Considered patients with chronic cough, sputum production or dyspnoea and/or risk factors (tobacco use, a-1 antitrypsin deficiency, occupational exposures to dust/chemicals); confirm by spirometry. Stepwise management/treatment: Based on disease severity, differentiate acute exacerbations and stable COPD (as management differs). (See Guidelines for Management of COPD in Section 11.1). Treatment does not change overall long-term lung function decline but smoking cessation can slow decline rate. Management components: Assess/Monitor Disease, Reduce Risk Factors, Manage Stable COPD and Manage Exacerbations. Key Points in Stable COPD Management: • Overall approach characterised by stepwise increase in treatment, depending on disease severity. • Health education to improve ability to cope with the illness, health status. Include smoking cessation. • Pharmacotherapy for COPD is used to decrease symptoms and/or complications. None of the existing medications for COPD has been shown to modify the long-term decline in lung function characteristic of the disease. • Bronchodilators are central to symptomatic management. Given on ‘as needed’ basis or on a regular basis to prevent or reduce symptoms. • Principal bronchodilator treatments are beta2-agonists (Short-acting: Fenoterol, salbutamol, terbutaline; Long-acting: Formoterol, salmeterol), anticholinergics (Short-acting: Ipratropium bromide, oxitropium bromide; Long-acting: Tiotropium), theophylline and a combination of one or more of these drugs. • Regular treatment with long-acting bronchodilators is more effective and convenient than treatment with short-acting bronchodilators, but more expensive. • The addition of regular treatment with inhaled glucocorticosteroids to bronchodilator treatment is appropriated for symptomatic COPD patients with and FEV1<50% predicted (Stage III: Severe COPD and Stage IV: Very Severe COPD) and repeated exacerbations. • Chronic treatment with systemic glucocortico-steroids should be avoided because of an unfavourable benefit-to-risk ratio. • All COPD patients benefit from exercise training programmes, improving with respect to both exercise tolerance and symptoms of dyspnoea and fatigue. • The long-term administration of oxygen (>15 hours per day) to patient with chronic respiratory failure has been shown to increase survival. References available on request. Revised: August 2003
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY ALSO BECLAZONE CFC-FREE INHALER Beclometasone diproprionate 50mcg, 100mcg, 200mcg, 250mcg per dose. Metered dose aerosol. 50mcg-200 dose unit, A5.09; 100mcg-200 dose unit, A9.95; 200mcg-200 dose unit, A20.05; 250mcg-200 dose unit, A21.24. S Management of bronchial asthma. P Usually 100mcg 3-4 times daily or 150200mcg twice daily. Severe cases, initially 600800mcg daily, reducung according to response. Q 50-100mcg two to four times daily. B Active or quiescent pulmonary tuberculosis. Pregnancy. Transfereing from systemic steroids. A Hoarseness, candidiasis of mouth.
BRONCHODILATORS, OTHER 4MO ALSO BECOTIDE 250 Beclomethasone dipropionate 250mcg per dose. Metered dose aerosol. 200-dose unit (CFC free), A26.78. P 1 puff twice daily increasing to 2 puffs two to four times daily according to response. Q Not recommended. B Active or quiescent pulmonary tuberculosis. Pregnancy. Transferring from systemic steroids. A Hoarseness, candidiasis of mouth and throat. Hypersensitivity reactions.
ANTI-ASTHMATICS
11.1
per 2ml soln. Single dose unit. 20, A4.36. P 5-10mg two to four times daily in nebuliser. Q Under 25 kg, use multidose bottles; over 25 kg, 5mg two to four times daily in a nebuliser.
5NO
ALSO BRICANYL INJECTION Terbutaline sulph. 0.5mg/ml. 1ml amp. 5, A1.61. S Relief of brochospasm in bronchial asthma and other bronchopulmonary disorders. Management of uncomplicated preterm labour (arrest labour between 24-33 weeks of gestation if no medical or obstetric contraindication to BRICANYL TURBOHALER AstraZeneca tocolytic therapy). P Bronchodilation: 0.25mg-0.5mg SC, IM 5MO or slow IV inj. up to 4 times daily or 1.5-2.5mg by Selective b2-agonist. Terbutaline sulph. 0.5mg per BECOTIDE EVOHALER A&H IV inf. Premature labour: See SPC. dose. Breath-actuated, metered-dose dry powder Q Over 2 years, 10mcg/kg body weight SC, 4MO inhaler. 100-dose unit, A10.62 S Relief and prevention of bronchospasm IM or slow IV inj. up to 4 times daily. Max. single Corticosteroid. Beclomethasone dipropionate in bronchial asthma and in chronic bronchitis and dose 300mcg. 50mcg, 100mcg per dose. CFC free metered dose B Hyperthyroidism, myocardial aerosol. 50mcg-200-dose unit, A2.53; 100mcg-200- other bronchopulmonary disorders in which insufficiency, thyrotoxicosis, cardiac arrhythmias, bronchospasm is a complicating factor. dose unit, A12.53. severe heart disease (monitor symptoms of V 1 inhalation (0.5mg) as required. Not S Bronchial asthma. worsening), diabetes, acute sever asthma. more than 4 inhalations should be necessary in P 400mcg daily in two, three or four Pregnancy. Do not use in case of hypertrophic any 24 hour period. divided doses. Severe cases, initially 600-800mcg cardiomyopathy. 5MO daily, reducing according to response. ALSO BRICANYL RESPULES Terbutaline sulph. 5mg C Avoid non-selective b-blockers. Caution: Q 50-100mcg two to four times daily. Sympathomimetics; xanthine derivatives, corticosteroids, diuretics (hypokalaemia). A Tremor, headache, tachycardia, palpitations, muscle spasms, hypokalaemia.
Anti-Doping Information d
BUDESITAN
This medicine is permitted but should be declared on the Doping Control Form at the time of testing.
Corticosteroid. Budesonide 0.5mg/2ml, 1mg/2ml. White to off-white suspension. 0.5mg/2ml-20, A25.49; 1mg/2ml-20, A36.78. S Persistent bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is unsatisfactory or inappropriate. P Twice daily, by inhalation. Once daily admin. may be considered for mild to moderate stable asthma. Initiation and maintenance: 0.52mg daily. May be increased further in very severe cases. Patients in maintenance therapy with oral steroids: See SPC. Q q12 years: As per adults. q6 months: Initially, 0.25-1mg daily; consider higher initial dose up to 2mg daily for patients in maintenance therapy with oral steroids. Maintenance: 0.25-1mg daily. B Not indicated for acute dyspnoea or status asthmaticus. Caution when switching from systemic treatment. Systemic effects of inhaled corticosteroids may occur, particularly at high doses, for prolonged periods. Discontinue immediately if paradoxical bronchospasm occurs. Monitor HPA axis function regularly in patients at risk of impaired adrenal function (previous prolonged systemic corticosteroid therapy, severe hepatic dysfunction). Advise patients to rinse out their mouth properly/brush their teeth after each admin. to reduce risk of oral candidiasis and hoarseness. Treat acute respiratory tract bacterial infections with appropriate antibiotics. Caution: Active and quiescent pulmonary tuberculosis, fungal, viral or other airways infections (concomitant treatment required). Monitor height of children receiving prolonged treatment. Pregnancy, lactation (if benefits outweigh risks). C Avoid: Ketoconazole, potent CYP3A4 inhibitors (erythromycin, clarithromycin, itraconazole, ketoconazole, ritonavir, saquinavir). Systemic or intranasal steroids. b-2sympathomimetics.
b Salbutamol to a maximal dose of 1600 micrograms over 24 hours (e.g. a dose of two puffs of 100mcg per puff, up to four times daily – over 24 hours) is permitted but must be declared at the time of testing. Salbutamol over a maximum of 1600mcg over 24 hours must have a medical file in place and may require a TUE. The presence of salbutamol in urine in excess of 1000ng/mL is presumed not to be an intended therapeutic use of the substance and will be considered as an Adverse Analytical Finding unless the Athlete proves, through a controlled pharmacokinetic study, that the abnormal result was the consequence of the use of a therapeutic dose of inhaled salbutamol.
Clonmel
4MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
255
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
RESPIRATORY
bronchitis and emphysema. Limited use for relief of breakthrough symptoms. P Maintenance: 1-2 inhalation caps. twice daily.Relief of breakthrough symptoms: 1-2 extra COMBINEB Clonmel DUOVENT Boehringer Ing. inhalation caps. per day on not more than 2 days per week. 9MO 5MO Q Not recommended Selective b2-agonist/anticholinergic. Ipratropium Selective b2-agonist/anticholinergic. Fenoterol B Ischaemic heart disease, cardiac bromide (monohydrate) / salbutamol (sulphate), hydrobromide 1.25mg, ipratropium bromide arrythmias, pregnancy, lactation. 0.5mg/2.5mg per 2.5ml. Colourless nebuliser sln in 500mcg per 4ml. Preservative-free soln. in single C b-blockers, sympathomimetics. amp. 2.5ml-60, A26.40. dose units. 20 x 4ml, A10.79. A Tremor, headache, palpitations. S Bronchospasm in patients with COPD S Acute asthma or reversible airways who require regular treatment with both disorders. GERIVENT Gerard ipratropium bromide and salbutamol. P Over 14 years, 1 vial nebulised P 1 amp. 3 or 4 times daily. immediately. Repeat dose, max.4 vials in 24 hours. 9 M O Q Over 12 years, as per adults. B Hyperthyroidism, myocardial Selective b-agonist. Salbutamol 100mcg per dose; D Hypertrophic obstructive insufficiency, angina, cardiac arrhythmias, metered-dose aerosol. 200-dose CFC Free, A2.80. cardiomyopathy or tachyarrhythmia. hypertension. Glaucoma, prostatic hypertrophy. S Treatment and prophylaxis of bronchial B Advise to consult doctor immediately if C Sympathomimetics. asthma. Treatment of reversible airways acute, rapidly worsening dyspnoea or reduced A Headache, peripheral vasodilatation. Dry obstruction with chronic bronchitis and response to treatment occurs. Discontinue mouth. emphysema. immediately if inhalation-induced P Acute attack 1-2 puffs. Prophylaxis 2 A & H puffs, not more than every 4 hrs. Max. 8 puffs in bronchoconstriction or paradoxical bronchospasm FLIXOTIDE EVOHALER occurs. Assess benefit vs risk: Inadequately 24 hrs. 4MO controlled diabetes, recent MI, severe organic Q Acute attack and prophylaxis: 1 puff Corticosteroid. Fluticasone propionate 50mcg, heart / vascular disorders, hyperthyroidism, increasing to 2 if necessary. Max. 8 puffs in 24 hrs. 125mcg, 250mcg per dose. CFC-free metered dose D Preterm labour and threatened phaeochromocytoma, prostatic hypertrophy, inhaler. 50mcg-120-dose unit, A8.19; 125mcg-60bladder outflow obstruction, narrow-angle dose unit, A12.44; 120-dose unit, A24.86; 250mcg- abortion. B Risk of potentially serious glaucoma risk. Warn patients not to let Combineb 60-dose unit, A21.13; 120-dose unit, A42.26. enter the eyes. If acute narrow-angle glaucoma S Treatment and prevention of bronchial hypokalaemia, unwanted stimulation of cardiac adrenergic receptors. Do not increase dose develops, initiate treatment with miotic eye drops asthma and COPD. without medical advice. Caution: Angina, severe and seek specialist advice immediately. May occur: P Asthma, 100-1000mcg twice daily. tachycardia, thyrotoxicosis. Pregnancy, lactation Immediate hypersensitivity reactions, potentially COPD, 500mcg twice daily. + (only if benefit outweighs risk). serious hypokalaemia (monitor K levels). Caution: Q Asthma, under 4 years, not C Avoid b-blockers. Caution: Xanthine CF (risk of GI disturbances). Pregnancy (esp. 1st recommended; over 4 years, 50-100mcg twice derivatives, steroids, diuretics, long-term laxatives, trimester), lactation. daily. halogenated anaesthetics, guanethidine, reserpine, C Caution: b2-agonists, corticosteroids, 4MO methyldopa, MAOIs, TCAs. anticholinergics, xanthine derivatives, MAOIs, ALSO FLIXOTIDE DISKUS Fluticasone propionate A Mild tremor, headache, palpitations, TCAs, diuretics, digoxin. Anaesthetics containing 50mcg, 100mcg, 250mcg, 500mcg per dose. Breath tachycardia. halogenated hydrocarbons: Monitor closely or actuated inhaler. 50mcg-60 dose unit, A6.97; consider discontinuing Combineb prior to surgery. 100mcg-60 dose unit, A12.19; 250mcg-60 dose IPRAMOL STERI-NEBS Teva A Accommodation disorders, palpitations, unit, A25.33; 500mcg-60 dose unit, A42.96. 9MO tachycardia, coughing, dysphonia, dryness of S Prophylactic management of asthma mouth, nausea, headache. Anticholinergic/b2-agonist. Ipratropium bromide (as and treatment of COPD. monohydrate) 0.5mg and salbutamol (as sulphate) P Asthma, 100-1000mcg twice daily. COMBIVENT UDV Boehringer Ing. COPD, 500mcg twice daily. 2.5mg. Nebuliser sln 20, A7.87; 60, A23.62. S Bronchospasm in patients with COPD Q Asthma, under 4 years, not 9MO who require regular treatment with both Selective b2-agonist/anticholinergic. Salbutamol (as recommended; over 4 years, 50-100mcg twice ipratropium bromide and salbutamol. daily. sulph.) 2.5mg, ipratropium bromide 500mcg per P 1 three or four times daily. 4MO 2.5ml single dose unit. Nebuliser soln. 20, A5.56; ALSO FLIXOTIDE NEBULES Fluticasone propionate Q Over 12 years, as per adults; under 12 60, A16.67. 0.5mg, 2mg per 2ml. Susp. in single use amps. for years, not recommended. S Bronchospasm in patients with COPD D Hypertrophic obstructive inhalation by nebulisation. 0.5mg/2ml-10 x 2ml, who require regular treatment with both cardiomyopathy or tachyarrhythmia. Pregnancy, A9.77; 2mg/2ml-10 x 2ml, A39.07. ipratropium bromide and salbutamol. lactation (unless benefit outweighs risk). S Prophylactic management in severe P 1 unit nebulised three or four times B Monitor for signs of acute narrow-angle asthma. Treatment of acute exacerbations of daily. glaucoma. Inadequately controlled diabetes Q Under 12 years, not recommended. Over asthma. mellitus, recent MI, severe organic heart/vascular P 500-2000mcg twice daily via a nebuliser. 12 years. as per adults. disorders, hyperthyroidism, pheochromocytoma, Q Under 4 years, not recommended; 4-16 D Hypertrophic obstructive prostatic hypertrophy; careful assessment of risk/ years, 1000mcg twice daily. cardiomyopathy or tachyarrhythmia. Pregancy, benefit. Hypersensitivity reaction, potentially B Active or quiescent pulmonary lactation (unless benefit outweighs risk). serious hypokalaemia may occur. Cystic fibrosis tuberculosis. Pregnancy, lactation. Transferring B Caution: Severe vascular or heart (risk of GI disturbances). from systemic steroids. disorders, recent MI, diabetes, hyperthyroidism, C Caution: Corticosteroids, A Hoarseness, candidiasis of mouth and pheochromocytoma, risk of narrow-angle anticholinergics, xanthine derivatives, MAOIs, throat. Paradoxical bronchospasm. Rarely rash, glaucoma, prostatic hypertrophy, bladder-neck TCAs, anaesthetics containing halogenated peripheral oedema. obstruction, severe airway obstruction. May occur: hydrocarbons. Immediate hypersensitivity reactions, potentially FORADIL Novartis A Headache, palpitations, tachycardia, dry serious hypokalaemia, ocular complications (when mouth, nausea, coughing, dysphonia, 5MO sprayed inadvertently in eye). Advise patient to accommodation disorders. Selective long-acting b2-agonist. Formoterol seek medical advice if dyspnoea worsens. Warn fumarate 12mcg. Dry powder capsules; breath patients with underlying severe heart disease to IPRAVENT Clonmel actuated inhaler device. 60 with inhaler device, seek medical advice if symptoms of worsening 2MO A26.09. heart disease occur. Anticholinergic. Ipratropium bromide 250mcg/1ml. S Maintenance treatment of reversible C b-blockers, corticosteroids, xanthine Nebuliser sln. 1ml-20, A4.08; 2ml-20, A4.85. obstructive airways disease in asthma, chronic derivatives, other b-agonists, anticholinergics, A Oropharyngeal candidiasis, hoarseness, cough, oral mucosal irritation, difficulty in swallowing.
256
inhalation of halogenated hydrocarbon anaesthetics. A Dry mouth.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY
BRONCHODILATORS, OTHER inhalations in 24 hrs. Q 6-12 years: Symptomatic treatment, as per adults. Prevention, one inhalation (100mcg) taken 10-15 mins prior to challenge and a further inhalation if necessary. Max. 4 inhalations in 24 hrs. B Should not be only treatment in moderate to severe or unstable asthma. Instruct patient in regular measurement of PEFR. Seek medical advice if asthma control not improved or more inhalations are required. Caution: Serious cardiac disorders, CHD, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, severe and untreated hypertension, aneurysm, hyperthyroidism, diabetes, phaeochromocytoma. Risk of potentially serious hypokalaemia; caution in acute severe asthma. Pregnancy, lactation (only if benefit outweighs risk). C Avoid non-selective b-receptor blocking drugs. Caution: Xanthine derivatives, glucocorticoids, diuretics, cardiac glycosides; monitor serum K+. Halogenated anaesthetics; use salbutamol 6 hours before. MAOIs, TCAs. A Restlessness, fine tremor, dizziness, Meda cough, nausea, taste alteration, sweating, headache, appl. site reaction.
S Reversible bronchospasm associated with COPD. With concomitant inhaled b2-agonists, for treatment of reversible airways obstruction as in acute and chronic asthma. P 250-500mcg 3 to 4 times daily. Acute bronchospasm: 500mcg. Repeated doses can be admin. until patient stable. Daily doses q 2mg only under medical supervision. Q Over 12 years, as per adults. 6-12 years: 250mcg, up to 1mg total daily dose. 0-5 years (acute asthma only): 125-250mcg, up to 1mg total daily dose, with at least 6 hourly intervals between doses. B Caution: Narrow-angle glaucoma (protect eyes), prostatic hyperplasia, bladderoutflow obstruction, cystic fibrosis (risk of GI disturbances). Immediate hypersensitivity reactions may occur. Warn patients not to let sln or mist enter eyes. Pregnancy, lactation. C b-adrenergic drugs, xanthine preparations. A Headache, cough, local irritation, GI disorders.
ANTI-ASTHMATICS
11.1
unusually responsive to b2-agonists. Discontinue if clinically significant cardiovascular effects occur. May occur: Significant hypokalaemia, plasma glucose increases. Pregnancy, lactation (use if benefits outweigh risks). Contains lactose. C Caution: Sympathomimetic agents, methylxanthine derivatives, steroids, non-K+sparing diuretics, b-blockers. A Nasopharyngitis, upper RTI, sinusitis, diabetes mellitus, hyperglycaemia, headache, ischaemic heart disease, cough, pharyngolaryngeal pain, rhinorrhoea, respiratory tract congestion, muscle spasm, peripheral oedema.
OXIS TURBOHALER
AstraZeneca
5MO
Selective b2-agonist. Formoterol fumarate 6mcg, 12mcg per dose. Breath-actuated metered-dose powder inhaler. 6mcg-60 dose unit, A20.11; 12mcg-60 dose unit, A25.24. S Relief of broncho-obstructive symptoms in asthma patients when corticosteroids alone are not adequate. Exercise induced asthma. P 6-12mcg once or twice daily in the NOVOLIZER BUDESONIDE morning and/or night; max. 72mcg daily. 4MO Q Over 6 years, 12mcg once or twice daily; max. 24mcg. Corticosteroid. Budesonide 200mcg per dose. NUELIN SA Meda B Severe cardiovascular disorders, Inhalation powder. 100-dose unit, A18.52; refill, 2MO A12.37. diabetes. Pregnancy, lactation. 4MO Xanthine. Theophylline 175mg white sust.-release C b-blockers, sympathomimetics, anaesthetics. tab. marked NLS 175 and 3M. 60, A3.66. ALSO NOVOLIZER BUDESONIDE 400 Budesonide A Rare tremor, palpitations, headache. 400mcg per dose. Inhalation powder. 50-dose unit, S Bronchospasm. P 1-2 twice daily after food. A18.52. Q Under 6 years, not recommended; over PHYLLOCONTIN CONTINUS S Persistent asthma. 6 years, 1 twice daily after food. Mundipharma P Initially, 200-400mcg once daily (evening) or twice daily. Max. 800mcg twice daily. 2 M O 2MO ALSO NUELIN SA-250 Theophylline 250mg white For maintenance titrate to lowest effective dose. Xanthine. Aminophylline 225mg. Pale yellow filmscored sust.-release tab. marked NLS 250 and 3M. Admin. regularly even when asymptomatic. ctd sust.-release tab. marked SA one side, Napp Q 6-12 years, initially 200mcg twice or 200- 60, A5.13. logo on reverse. 56, A3.91. 400mcg once daily; max. 400mcg twice daily. Over P 1-2 twice daily after food. S Bronchospasm associated with asthmas, Q Under 6 years, not recommended; over emphysema and chronic bronchitis. 12 years, as per adults. 6 years, half adult dose after food. B Not indicated for treatment of acute P Initially 1 12-hourly for one week, then B Cardiac or liver disease, peptic ulcer, dyspnoea or status asthmaticus. Severe hepatic maintenance 2 twice daily. insomnia, hyperthyroidism, severe hypertension, dysfunction. Active and quiescent pulmonary Q Use paed. tabs. epilepsy. Pregnancy, lactation. tuberculosis, fungal, viral or other infections of D Hypersensitivity to xanthine group of C Cimetidine, allopurinol, corticosteroids, the airways (concomitant treatment required). drugs. Pregnancy (only if essential), lactation. frusemide, isoprenaline, oral contraceptives, Monitor height of children receiving prolonged B Cardiac or liver disease, viral infection, treatment. Caution when switching from systemic thiabendazole, ciprofloxacin, erythromycin or elderly; reduce dose. History of seizure (not other macrolide antibiotics, phenytoin, treatment. Should not be stopped abruptly. advised), insomnia. carbamazepine, barbiturates, lithium, rifampicin, Pregnancy, lactation (only if benefit outweighs C Cimetidine, erythromycin, sulpnpyrazone, fluvoxamine, adrenergic agonists, risk). Contains lactose. sympathomimetics in children. b-adrenergic glucagon, xanthines, St John’s wort. C Ketoconazole (avoid). Caution: Other agonists, glucagon, ephedrine. A Tachycardia, nausea, GI distress, potent inhibitors of CYP3A4. A Nausea, gastric irritation, headache, CNS headache, insomnia, arrhythmias. A Oropharyngeal candidiasis, hoarseness, stimulation. cough, oral mucosal irritation, swallowing ONBREZ Novartis PROLASTIN SBL Vaccin AB difficulty.
NOVOLIZER SALBUTAMOL
Meda
5O
b2-agonist. Indacaterol 150mcg, 300mcg. Inhalation 9MO powder, in clear colourless hard cap. 150mcg-30, A34.56; 300mcg-30, A34.56 Selective b2-agonist. Salbutamol 100mcg (as the sulphate) per delivered dose. Inhalation powder. S Maintenance bronchodilator treatment 200-dose unit, A8.24; refill, A5.96. of airflow obstruction in adult patients with COPD. S Conditions with associated reversible P For inhalation use only, using the airway obstruction, e.g. asthma or chronic Onbrez Breezhaler inhaler. One 150mcg cap. once obstructive pulmonary disease with a substantial daily. Severe COPD, one 300mcg cap. once daily. component of reversibility. Prevention of asthma Max. 300mcg once daily. attacks induced by exercise or exposure to R As per adults. allergens. Q Under 18 years, not recommended. P Symptomatic treatment, 1 inhalation (100mcg) as starting dose. If no improvement after B Not for use in asthma. Discontinue if 5-10 mins, a 2nd inhalation may be taken. At least paradoxical bronchospasm occurs. Not indicated for acute episodes of bronchospasm (i.e. as rescue 4 hours should elapse between each dose. Prevention, 2 inhalations taken 10-15 mins prior to therapy). Caution: Cardiovascular disorders, convulsive disorders, thyrotoxicosis, patients challenge with interval of min. 1 min. Max. 8
2J Serine proteinase inhibitor. Alpha1-proteinase inhibitor (human) 1000mg per vial and 25mg in 1ml of reconstituted solution. Powder and solvent for solution for infusion. 1 pack, A336.24. S Long-term augmentation therapy in subjects with Alpha1-proteinase inhibitor deficiency (phenotypes PiZZ, PiZ(null), Pi (null,null) and PiSZ) within the limits of moderate airflow obstruction (FEV1 35-60%) and the evaluation of the clinical condition (disability). P 60mg/kg body weight once-weekly (equivalent to 18ml reconstituted 25mg/ml solution for a patient weighing 75kg) as a shortterm infusion. This is usually sufficient to keep the serum alpha1-proteinase inhibitor level constantly over 80mg/dl which correlates with pulmonary levels of 1.3mcM.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
257
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
An Option* for Mild Asthma!
RESPIRATORY
Q Under 18 years, not recommended. D Selective IgA deficiency, with antibodies against IgA. B May occur: Severe hypersensitivity reaction; discontinue immediately, institute suitable therapy with treatment for shock as necessary. Caution: Severe heart failure and risk of circulatory overload. Possibility of transmission of infective agents, particularly HAV and parvovirus B19; particular risk to pregnant women (fetal infection) and individuals with immunodeficiency or increased erythropoiesis; record batch number to maintain link with patient. Consider appropriate vaccination (HAV, HBV) for patients in regular repeated receipt of human plasma-derived proteinase inhibitors. Smoking cessation recommended. Pregnancy (caution), lactation. Contains Na+. A Fever, flu-like symptoms, dyspnoea, urticaria, nausea.
PULMOZYME
Genentech/Roche
2NT Recombinant human deoxyribonuclease. Dornase alfa 2.5mg/2.5ml. Plastic amp. containing 2500 U (2.5mg) per 2.5ml admin. by compressed air-driven nebuliser. 6, A171.00. S Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and to improve pulmonary function. P 2.5mg once daily by inhalation. Patients over 21 years may benefit from a twice daily dosage. B Pregnancy, lactation. A Pharyngitis, voice changes, chest pain, occasionally laryngitis, rashes, urticaria, and conjunctivitis.
QVAR
Teva
4MO
PULMICORT TURBOHALER
Corticosteroid. Beclomethosone dipropionate
AstraZeneca 50mcg,100mcg/dose. CFC-free metered dose
4MO Corticosteroid. Budesonide 100mcg, 200mcg, 400mcg per dose. Breath-actuated, metered-dose dry powder inhalers. 100mcg per dose-200 doses, A20.37; 200mcg per dose-100 doses, A20.42; 400mcg per dose-50 doses, A20.42. S Bronchial asthma in patients who have not previously been controlled on bronchodilators and/or anti-allergic agents. COPD. P The dosage should be individualised according to asthma severity. Max. 1600mcg daily in divided doses. In less severe cases 200-800mcg daily may be used. COPD: 400mcg twice daily. Q 200-800mcg daily in divided doses. During periods of severe asthma, daily dose may be increased to 800mcg. Maintenance dose should be lowest possible.
*INDICATION for ages 2 to 14 years
SINGULAIR® may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids.
O N C E D A I LY
®
Legal Category: POM Marketing Authorisation Numbers: ‘Singulair’ Paediatric 5 mg chewable tablet: PA 35/85/1; ‘Singulair’ Paediatric 4 mg chewable tablet: PA 35/85/3; ‘Singulair’ Paediatric 4 mg granules: PA 35/85/4. Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. Full prescribing Information is available from: Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18. Date of review: October 2009 ® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. © Merck Sharp & Dohme Ireland (Human Health) Limited 2008. All rights reserved.
10-11-SGA-2009-IRL-2773-J
258
4MO ALSO PULMICORT CFC-FREE INHALER Budesonide 100mcg, 200mcg. Metered dose aerosol. 120 dose. 100mcg, A10.68; 200mcg, A16.69. S Bronchial asthma, not previously well controlled on bronchodilators and/or anti-allergic agents. P 200mcg twice daily morning and evening. Severe asthma, up to 1600mcg daily. Well controlled patients, daily dose may be reduced below 400mcg but not below 200mcg. Not for use in acute attacks. Q Under 12 years, 100-400mcg twice daily, max 800mcg/day. Over 12 years, as per adults.
4MO ALSO PULMICORT RESPULES Budesonide 0.5mg, 1mg per 2ml. Single dose amps. for nebulisation. 0.5mg per 2ml-20 x 2ml, A31.85; 1mg per 2ml-20 x 2ml, A45.97. S Bronchial asthma in patients where use of a pressurised inhaler or dry powder formulation is inappropriate. Use in infants and children with acute larygnotrachitis-croup. P 1-2mg twice daily, maintenance 0.5mg twice daily. Q Under 12 years, asthma, 0.5-1mg twice daily, maintenance 0.25-0.5mg twice daily; croup, 2mg as single admin. Over 12 years, same as adults. B Active or quiescent pulmonary tuberculosis. Pregnancy. Transferring from systemic steroids. A Hoarseness, candidiasis of mouth and throat.
aerosol or autohaler. AeroChamber Plus device compatible with aerosol. 200-dose 50mcg-1, A10.34; 200-dose 100mcg-1, A22.09. S Prophylactic anti-inflammatory treatment of reversible obstructive airway disease. P Starting/maintenance: Mild/moderate asthma, 50-200mcg twice daily; severe, up to 400mcg twice daily. Max. 800mcg daily. Q Under 5 years, not recommended; 5-11 years, 50mcg twice daily. Reduce to min. maintenance control dose. B Active or quiescent pulmonary tuberculosis. Transferring from systemic steroids. A Hoarseness, candidiasis of mouth and throat.
SALAMOL EASI-BREATHE
Teva
9MO Selective b2-agonist. Salbutamol 100mcg per dose. Breath-actuated inhaler, both CFC and CFC-free. 200-dose unit, A7.56.
9MO ALSO SALAMOL CFC-FREE INHALER Salbutamol 100mcg per dose. 200-dose, A2.81. S Treatment and prophylaxis of bronchospasm, treatment of bronchitis and emphysema, relief of acute dyspnoea. P Acute attack, 1-2 puffs. Prophylaxis, 2 puffs three or four times daily. Q Half adult dose. B Hyperthyroidism, serious cardiovascular disorders, hypertension, pregnancy, diabetes. See SPC. C Sympathomimetics. b-blockers. A Fine tremor, slight tachycardia, nervous tension, headache, peripheral vasodilation, hypokalaemia, hypersensitivity reactions.
SALBUVENT
Clonmel
9MO Selective b2-agonist. Salbutamol (sulphate) 2.5mg. Clear, colourless to pale yellow nebuliser sln in a clear, plastic single dose amp. 2.5 mg/2.5ml-20, A2.45; 5 mg/2.5ml-20, A6.07. S Routine management of chronic bronchospasm unresponsive to conventional therapy. Treatment of acute severe asthma. P Initially 2.5mg (single dose); may be increased to 5mg. May be repeated up to 4 times a day. Severe airways obstruction in hospitalised patients, up to 40mg per day under strict medical
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY supervision. Q Initially 0.1-0.15mg/kg bodyweight up to max. starting dose of 2.5mg (single dose). May be increased to 5mg. May be repeated up to 4 times a day. Under 18 months, clinical efficacy uncertain. D Not for premature labour management. Not for use in threatened abortion. B Caution (only use if strictly indicated): Serious cardiac disorders, coronary heart disease, hypertrophic obstructive cardiomyopathy, tachyarrhythmia, severe untreated hypertension, aneurysm, hyperthyroidism, difficult to control diabetes, phaeochromocytoma. Warn patients to seek medical advice if chest pain or other symptoms of worsening heart disease occur. Risk of potentially serious hypokalaemia. Monitor blood glucose in diabetics. Pregnancy, lactation (only if benefit outweighs risk). C Caution: Other sympathomimetics, nonselective b-blockers, xanthine derivatives, glucocorticoids, diuretics, cardiac glycosides, TCAs, corticosteroids, ipratropium bromide. A Restlessness, fine tremor, dizziness, nausea, taste alteration, pruritus, rash, erythema, urticaria, angioedema, headache, appl. site reactions.
BRONCHODILATORS, OTHER
ANTI-ASTHMATICS
11.1
25mcg per dose; metered dose aerosol. 120-dose unit, A28.13. S Long-term regular treatment of obstructive airways disease, due to asthma (incl. nocturnal and exercise-induced asthma), and COPD. P Asthma, 2 puffs twice daily. Severe cases, up to 4 puffs twice daily. COPD, 2 puffs twice daily. Q Not recommended.
4MO ALSO SEREVENT DISKUS Salmeterol (as xinafoate) 50mcg per dose; breath operated inhaler. 60 dose unit, A27.26. P Asthma, 1 blister twice daily. Severe cases, up to 2 blisters twice daily. COPD, 1 blister twice daily. Q Not recommended. B Pregnancy, lactation. C b-blockers. A Rarely tremor, headache, subjective palpitations.
SINGULAIR
MSD
2NO
Leukotriene receptor antagonist. Montelukast (as Na+) 10mg. Beige square film-ctd tab. marked with tab. name and MSD 117. 28, A32.94. SERETIDE DISKUS A&H S Add-on therapy in mild to moderate 4MO asthma inadequately controlled by inhaled Selective long-acting b2-agonist/corticosteroid. corticosteroids and short-acting b-agonists. Salmeterol (xinafoate) 50mcg, and fluticasone Symptomatic relief of concomitant seasonal (propionate). Breath-actuated inhaler. Seretide 100 allergic rhinitis in adult asthma patients (15 years Diskus (50mcg salmeterol/100mcg fluticasone) 60 and older). Exercise induced bronchoconstriction. dose unit, A32.06; Seretide 250 Diskus (50mcg 2NO salmeterol/250mcg fluticasone) 60 dose unit, ALSO SINGULAIR PAEDIATRIC Montelukast (as A44.70; Seretide 500 Diskus (50mcg salmeterol/ Na+) 4mg, 5mg. Pink chewable tab. marked with 500mcg fluticasone) 60 dose unit, A66.71. tab. name and MSD 711 or MSD 275. 4mg-28, S Regular treatment of asthma where use A32.94. 5mg-28, A32.94. of a bronchodilator and inhaled corticosteroid S Add-on therapy in mild to moderate together is considered appropriate. COPD in asthma inadequately controlled by inhaled adults. corticosteroids and short-acting b-agonists. P Asthma in adults and children 12 years Alternative to low-dose inhaled corticosteroids in and older: 1 puff twice daily. COPD: 1 puff twice patients (2 years and older) with mild persistent daily (Seretide 500). asthma without a recent history of serious asthma Q 4-12 years, 1 puff twice daily (Seretide attacks that required oral corticosteroid use, and 100); under 4 years, not recommended. are incapable of using inhaled corticosteroids. 4MO Exercise induced bronchoconstriction in patients 2 ALSO SERETIDE EVOHALER Salmeterol (xinafoate) years and older. 25mcg, plus fluticasone (propionate). CFC-free P 10mg daily in the evening with or MDI. Seretide 50 Evohaler (25mcg salmeterol/ without food. 50mcg fluticasone) 120 dose unit, A26.96; Seretide Q Under 2 years, see Singulair Paediatric 125 Evohaler (25mcg salmeterol/125mcg Granules, below. 2-5 years, 4mg in the evening. 6fluticasone) 120 dose unit, A44.70; Seretide 250 14 years, 5mg in the evening. If with food, take 1 Evohaler (25mcg salmeterol/250mcg fluticasone) hour before or 2 hours after. 120 dose unit, A66.71. 2NO P Asthma in adults and children 12 years ALSO SINGULAIR PAEDIATRIC GRANULES and older: 2 puffs twice daily. Montelukast (as Na+) 4mg. Granules in sachets. 28, Q 4-12 years: 2 puffs of 25/50mcg twice A32.94. daily. Max. fluticasone dose, 100mcg twice daily. S As per Singulair Paediatric. Under 4 years, not recommended. Q 6 months-5 years: One sachet daily in B Acute asthma symptoms - use short the evening. Under 6 months, not recommended. acting b-agonist. Severe cardiovascular disorders, Admin. directly in mouth, or mixed with spoonful diabetes mellitus, untreated hypokalaemia, of cold or room temperature soft food. When thytoroticosis, pulmonary tuberculosis, transferring mixed, do not store for future use. Continue from systematic steroids. Pregnancy, lactation. treatment even if asthma is under control. C b-blockers, b-agonists. B Singulair: Do not substitute for inhaled A Candidiasis of the mouth and throat, or oral steroid therapy. Paediatric Singulair: Do headache, palpitations, tremor, throat irritation, not abruptly substitute for inhaled or oral hoarseness/dysphonia, muscle cramps. corticosteroids. Do not use for relief of acute asthma symptoms. Discontinue if symptoms of SEREVENT A&H Churg-Strauss syndrome appear. Pregnancy, 4MO lactation (only if essential). Chewable tabs. contain aspartame. 10mg tabs. contain lactose. Selective b2-agonist. Salmeterol (as xinafoate)
For the treatment of asthma and allergic rhinitis in those asthmatic patients in whom SINGULAIR® is indicated O N C E D A I LY
®
Legal Category: POM Marketing Authorisation Number: ‘Singulair’ 10-mg tablet: PA 35/85/2 Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK. Full prescribing Information is available from: Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18. Date of review: September 2009 ® denotes registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA. © Merck Sharp & Dohme Ireland (Human Health) Limited 2009. All rights reserved.
10-11-SGA-2009-IRL-2772-J
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
259
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
RESPIRATORY
S Dilution of solutions for nebulisation. C Caution: CYP3A4 inducers (see Apx I). A Abdominal pain, headache, thirst. Very V As required. rarely, suicidal thinking and behaviour (suicidality).
SPIRIVA
Boehringer Ing.
2NO Anticholinergic. Tiotropium bromide monohydrate 22.5mcg (equiv. tiotropium 18mcg) with delivered dose of 10mcg with HandiHaler. Light green hard cap. containing white inhalation powder marked with company logo and product code for use with HandiHaler device. 30 + HandiHaler, A42.55; 30 (refill pack), A40.35. S Maintenance treatment of chronic obstructive pulmonary disease (COPD). P Inhale 1 cap. at the same time once daily using the HandiHaler. Q Under 18 years, not recommended.
2NO ALSO SPIRIVA RESPIMAT Tiotropium bromide monohydrate 3.124mcg equiv. tiotropium 2.5mcg per puff. Sln for inhalation. Respimat Soft Mist Inhaler (60 puffs), A48.79. P 5mcg given as two puffs at the same time once daily using Respimat inhaler. Q Under 18 years, not recommended. B Acute episodes of bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, moderate to severe renal impairment. Pregnancy, lactation (only if benefit outweighs risk). Caps. contain lactose. Driving/ using machines (if headache, dizziness or blurred vision occur). C Other anticholinergic drugs. A Dry mouth.
SYMBICORT TURBOHALER
Mundipharma
2MO
AstraZeneca Xanthine. Theophylline 200mg white cap. -shaped
5MO SYMBICORT TURBOHALER 200/6. Corticosteroid/ selective long acting b2-agonist. Budesonide 200mcg, formoterol fumarate dihydrate 6mcg per inhalation dose. White inhalation powder. 120 doses, A46.40. S Regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting b-agonist) is appropriate. Severe COPD in adults. P Asthma: Maintenance, 1-2 inhalations twice daily. Max. 4 inhalations twice daily. When control achieved with twice daily, consider once daily treatment. Maintenance and reliever therapy, 2 inhalations daily plus 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few mins, an additional inhalation should be taken. Max. 6 inhalations on any single occasion. Max. daily: 8 inhalations; 12 inhalations may be used for a limited period with medical advice. COPD: 2 inhalations twice daily. Q 12-17 year olds: Maintenance, 1-2 inhalations twice daily. Maintenance and reliever therapy: Not indicated.
5MO
ALSO SYMBICORT TURBOHALER 400/12 Budesonide 400mcg, formoterol fumarate dihydrate 12mcg per inhalation dose. White inhalation powder. 60-dose, A46.40. P Asthma: Maintenance, 1 inhalation STERI-NEB IPRATROPIUM Teva twice daily. Max. 2 inhalations twice daily. 2MO Maintenance and reliever therapy: Not indicated. Anticholinergic. Ipratropium bromide 250mcg/ml; COPD: 1 inhalation twice daily. preservative free single dose nebuliser soln. in Q Not recommended. vials. 20 x 1ml, A4.29; 20 x 2ml, A5.10. 5MO S Reversible airways obstruction. ALSO SYMBICORT TURBOHALER 100/6 P 0.4-2ml by nebuliser up to four times Budesonide 100mcg, formoterol fumarate daily. dihydrate 6mcg per inhalation dose. White Q Under 3 years, not recommended; over inhalation powder. 100/6-120 doses, A45.11. 3 years, 0.4-2ml by nebuliser up to three times S Regular treatment of asthma where use daily. of a combination (inhaled corticosteroid and long B Glaucoma, prostatic hypertrophy. acting beta-agonist) is appropriate. Not A Occasional paradoxical bronchospasm, appropriate for severe asthma. dry mouth, constipation, urinary retention. P Maintenance, 1-2 inhalations twice STERI-NEB SALAMOL Teva daily. Max. 4 inhalations twice daily. Maintenance and reliever therapy, see 200/6. 9MO Q 12-17 years, 1-2 inhalations twice daily. Selective b2-agonist. Salbutamol (as sulphate) 6 years and older, 2 inhalations twice daily. Under 2.5mg, 5mg per 2.5ml; preservative-free soln. in 6 years, not recommended. single dose units. 2.5mg/2.5ml_20, A3.01; 5mg/ B Withdraw gradually. Caution patients 2.5ml_20, A6.07. with: Thyrotoxicosis, phaeochromocytoma, S Management of chronic bronchospasm cardiovascular disorders, diabetes, hypokalaemia, unresponsive to conventional therapy. Treatment risk factors for osteoporosis. Pregnancy and of acute severe asthma. lactation (only if benefit outweighs risk). V 2.5mg nebulised up to three or four Transferring patients from systemic steroids. Not times daily. If necessary, increase to 5mg up to for initial management of asthma. Children: three or four times daily. Monitor height regularly. Contains lactose (incl. B Hyperthyroidism. Myocardial small amounts of milk proteins). insufficiency, angina, cardiac arrhythmias, C Avoid: Itraconazole, ritonavir, other hypertension. Pregnancy. C Sympathomimetics. potent CYP3A4 inhibitors, b-blockers. Caution: A Fine tremor, headache, peripheral Quinidine, disopyramide, procainamide, vasodilation, hypokalaemia. phenothiazines, antihistamines, MAOIs, TCAs, LDopa, L-thyroxine, oxytocin, alcohol, halogenated STERI-NEB SALINE Teva HC, digitalis glycosides. 2OY A Headache, palpitations, tremor, coughing, hoarseness, candidiasis of mouth and Nebuliser diluent. Sodium Cl 0.9%; preservative free soln in single dose unit. 20 x 2.5ml, A3.95. throat.
260
UNIPHYLLIN CONTINUS
scored sust.-release tab. marked U200; 300mg white cap.-shaped scored sust.-release tab. marked U300; 400mg white cap.-shaped scored sust.release tab. marked NAPP U400 one side, UNIPHYLLIN on reverse. 200mg-56, A4.17; 300mg56, A6.38; 400mg-56, A8.72. S Asthma, emphysema, chronic bronchitis. P Asthma: 200mg 12 hourly, in more severe cases 300mg or 400mg 12 hourly. Emphysema, chronic bronchitis: less than 70kg, 200mg 12 hourly for 1 week, then 300mg 12 hourly. Over 7- kg, 200 or 300mg 12 hourly for 1 week, then 400mg 12 hourly. Q Asthma, under 7 years, not recommended; over 7 years, usual maintenance 200mg 12 hourly. Chronic asthma may require 300mg 12 hourly. D Hypersensitivity to xanthine group of drugs. Lactation. B Cardiac or liver disease. Peptic ulceration, pregnancy, viral disease. C Cimetidine, erythromycin, b-adrenergic agonists, glucagon, ephedrine, ciprofloxacin, fluvoxamine, interferon, steroids, diuretics. See SPC. A Nausea, gastric irritation, headache, CNS stimulation.
VENTAMOL CFC-FREE
Pinewood
9MO Selective b2-agonist. Salbutamol 100mcg per actuation. Aerosol. 200 doses, A3.30. S Management of asthma symptoms, relief of wheezing and shortness of breath. Treatment of reversible airways obstruction. Prophylactic before exertion to prevent exerciseinduced asthma. V Acute attacks, 1-2 inhalations. Prophylaxis, 2 inhalations 10-15 min before challenge. Chronic therapy: 2 inhalations up to 4 times daily allowing 4 hrs between each dose; no more than 8 inhalations in 24 hrs. B Pregnancy, lactation, hypokalaemia. Caution: thyrotoxicosis C b- blockers. A Mild tremor, headache, palpitations, tachycardia, transient muscle cramps, hypokalaemia, hypersensitivity reactions, paradoxical bronchospasm, peripheral vasodilation, mouth and throat irritations, hyperactivity in children.
VENTOLIN EVOHALER
A&H
9MO Selective b2-agonist. Salbutamol 100mcg/dose. CFCfree metered dose aerosol. 200-dose unit, A3.03. S Prophylaxis and treatment of airways obstruction due to bronchial asthma and chronic obstructive airways disease. P Acute attack: 1-2 puffs; chronic therapy: 2 puffs up to four times daily; prevention of recognised allergen or exercise induced bronchospasm: 2 puffs. Q Half adult dose, up to adult dose if required.
5MO ALSO VENTOLIN TABLETS Salbutamol (sulph.) 2mg, 4mg. White round tabs. marked with a score line and GX CN3 or GX CN5 resp. on one side.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY
COUGH
2mg-100, A1.36; 4mg-100, A2.61.
agonists, glucagon. A GI disturbances (nausea, vomiting, anorexia). CNS stimulation, insomnia. Cramps, convulsions, supraventricular tachycardia, arrhythmias.
S Add-on therapy in patients with severe persistent allergic asthma despite daily high-dose ALSO VENTOLIN SYRUP Salbutamol (sulph.) 2mg/ inhaled corticosteroids, plus a long-acting inhaled b2-agonist (and with convincing IgE mediated 5ml. Sugar-, colouring-free. 150ml, 85c. asthma). P 4-8mg three or four times daily. P 75-375mg in 1 to 3 sc inj., depending on Q Under 2 years, not recommended. 2-6 baseline IgE and body weight, see SPC for detailed years: 3-8mg in three or four divided doses. 6-12 dosage. Max. 375mg every 2 weeks. Assess at 16 years: 6-8mg in divided doses. Over 12 years: 6weeks, continue if marked improvement in overall 16mg in divided doses. asthma control. Use initial dose determination 5NO following dose interruptions Q 1 year. ALSO VENTOLIN CONCENTRATE SOLUTION FOR IV R Over 65 years, limited data. INFUSION Salbutamol (sulph.) 1mg/ml. Amp. for Q Under 12 years, not recommended. IV inf. 5ml, A35.77. B Not indicated for acute asthma S Severe bronchospasm and status exacerbations, acute bronchospasm or status asthmaticus. Management of uncomplicated asthmaticus. Hyperimmunoglobulin E syndrome, premature labour in last trimester. P Bronchospasm and status asthmaticus: 3- allergic bronchopulmonary aspergillosis and prevention of anaphylactic reactions; no data. 20mcg/min (start with 5mcg/min) by IV slow inj. Caution: Autoimmune diseases, immune complexusing a 10mcg/ml dose (5ml of sln + 500ml of an mediated conditions, renal/hepatic impairment, inf. sln), adjust according to response. For transferring from systemic or inhaled premature labour: 10mcg/min by IV inf. Increase rate until evidence of response; usual range: 10-45 corticosteroids, patients at high risk of helminth infection, diabetics. Contains sucrose. Local or mcg/min. Once uterine contractions have ceased systemic allergic reactions may occur. Rarely maintain inf. rate at same level for 1 hour and antibodies to omalizumab may develop. then reduce by 50% decrements at 6-hourly A Headache, inj. site reactions, erythema, intervals. Treatment may be continued orally. pruritus, swelling. Q Not recommended.
5MO
5NO ALSO VENTOLIN INJECTION Salbutamol (sulph.) 5mcg/ml. Sln for inj. 10 x 5ml, A2.47. P Bronchospasm and status asthmaticus: 8mcg/kg SC or IM four hourly, or 4mcg/kg by slow IV inj. repeated if necessary. For premature labour: 100-250mcg by IV or IM single inj. Q Not recommended.
9MO ALSO VENTOLIN RESPIRATOR SOLUTION Salbutamol (sulph.) 5mg/ml. Bottle. 20ml, A3.14.
9MO ALSO VENTOLIN NEBULES Salbutamol (sulph.) 5mg/2.5ml. Preservative-free soln. in single dose unit. 2.5mg-20, A1.69; 5mg-20, A8.23. V 2.5-5mg up to four times daily via nebuliser.
9MO ALSO VENTOLIN DISKUS Salbutamol 200mcg/dose. Breath actuated inhaler. 60 dose unit, A6.16. V Acute attacks, 200mcg as required. Chronic maintenance or prophylaxis, 200mcg up to four times daily. Prevent exercise-induced asthma, 200mcg before challenge. B Hyperthyroidism, serious cardiovascular disorders, hypertension, diabetes. Pregnancy. See SPC. C Sympathomimetics, b-blockers, MAOIs, anaesthetics. A Fine tremor, slight tachycardia, nervous tension, headache, peripheral vasodilation, hypokalaemia, hypersensitivity reactions. Cardiac arrhythmias (incl. atria fibrillation, supraventricular tachycardia and extrasystoles) may occur, usually in susceptible patients.
VOLUMATIC
A&H
O Two-piece 750ml large volume reservoir chamber device to take aerosol with actuator i.e. Becotide, Flixotide, Serevent, Seretide or Ventolin inhalers. 1, A3.09.
XOLAIR
Novartis
2M Monoclonal antibody. Omalizumab150mg. Powder and solvent for soln. for inj. 1, A444.93.
PREPARATIONS
11.2
11.2 COUGH PREPARATIONS
ACTIFED TABLETS
McNeil Healthcare
0K Antihistamine/sympathomimetic. Triprolidine (HCl) 2.5mg, pseudoephedrine (HCl) 60mg. White scored tab. marked WELLCOME M2A. 12, A3.67. S Upper respiratory tract disorders such as allergic rhinitis, vasomoter rhinitis and common cold. P 1 every 4-6 hours, up to four times a day. Q Under 12 years, not recommended.
0K
ALSO ACTIFED SYRUP 10ml equiv. to 1 tab. 100ml, A3.99. S Upper respiratory tract conditions such as common cold, hay fever, allergic and vasomotor rhinitis and aerotitis. P 10ml every 4-6 hours, up to four times a day. Q Under 2 years, not recommended. 2-5 ZADITEN Novartis years, 2.5ml. 6-12 years, 5ml. Both every 4-6 hours, up to four times a day. 2MO D Severe hypertension or severe coronary Antihistamine/mast cell stabiliser. Ketotifen artery disease. (hydrogen fumarate) 1mg. White scored tab. B Severe hepatic impairment or moderate coded ZADITEN 1. 60, A9.92. to severe renal impairment. Caution as with other 2MO sympathomimetics. Epileptic patients. Risk of ALSO ZADITEN CAPS Ketotifen (hydrogen drowsiness and mental alertness impairment. fumarate) 1mg. White cap marked CS. 56, A10.89. Pregnancy, lactation. 2MO C MAOIs, furazolidone, other ALSO ZADITEN ORAL SOLN. Ketotifen (hydrogen sympathomimetics. Caution: Alcohol or other CNS fumarate) 1mg/5ml. 300ml, A10.88. depressants, antihypertensive agents, antiS Prophylaxis of bronchial asthma. cholinergics and TCAs. P 1-2mg twice daily with food. Q Under 2 years, not recommended; over A Insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions (CNS 2 years, 1mg twice daily with food. stimulant, particularly in children). D Pregnancy, lactation. B Withdraw over 2-4 weeks. Intercurrent ADVIL COLD & FLU Wyeth Healthcare infections should be treated with specific antimicrobial therapy. Reactions may be impaired. 0 K NSAID/sympathomimetic. Ibuprofen 200mg, C Alcohol, CNS depressants, oral pseudoephedrine (HCl) 30mg. Brown oval sug-ctd hypoglycaemics, antihistamines. tab. marked with tab. name. 20, A4.13. A Drowsiness, impaired reactions, dry mouth, dizziness. Occasionally CNS stimulation, S Relief of common cold and flu weight gain. symptoms incl. blocked sinuses. P 1-2 every four to six hours. Max. 6 in 24 ZEPHOLIN SR Astellas hours. Q Under 12 years, not recommended. 2MO D Aspirin/NSAID induced allergies. Active Xanthine. Theophylline 100mg, 200mg, 350mg. peptic ulcer, diabetes or thyroid disease. Heart Prolonged release caps. marked TH100, TH 200 disease, circulatory problems, hypertension or and TH 350, resp. 100mg, blue/white; others, coronary artery disease. Pregnancy, lactation. green. 100mg-56, A2.15; 200mg-56, A4.25; B Renal, cardiac or hepatic impairment. 350mg-56, A7.73. Elderly. Asthma, prostatic hypertrophy. Caution as S Symptomatic or prophylactic relief of with other NSAIDs. bronchospasm associated with asthma, chronic C MAOIs, TCAs, painkillers or bronchitis and emphysema. P Usually 400-1000mg daily in two divided decongestants, warfarin, heparin, other sympathomimetics, furazoline. Caution: doses adjusting according to response. Guanethidine, reserpine, methyldopa, Q Under 10kg body weight, not guanethidine, digitalis, quinidine and as with recommended; 10-20kg, 100mg twice daily; 20other NSAIDS. 40kg, 200mg twice daily. A Dyspepsia, GI bleeding, rash. Anxiety, D Hypersensitivity to xanthine group of tremor, tachycardia, arrythmias, dry mouth, CNS drugs. Pregnancy, lactation. stimulation. B Cardiac or liver disease, peptic ulceration, insomnia. BENYLIN CHESTY COUGH NON C Cimetidine, erythromycin, ciprofloxacin, DROWSY McNeil Healthcare allopurinol, oral contraceptives, b-adrenergic
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
261
11.2 COUGH
RESPIRATORY
PREPARATIONS
2 Expectorant/demulcents. Guaiphenesin 100mg, menthol 1.1mg/5ml. Syrup. 125ml, A3.69; 300ml, A5.75. P 10ml four times daily. Q Under 6 years, not recommended; 6-12 years, 5ml four times daily.
2 ALSO BENYLIN COUGH TRADITIONAL Diphenhydramine (HCl) 14mg, menthol 1.1mg/ 5ml. Syrup. 125ml, A3.93. S Cough, bronchial congestion. P 5-10ml three or four times daily. Q Under 6 years, not recommended; 6-12 years, 5ml three or four times daily.
2 ALSO BENYLIN DRY COUGH Diphenhydramine (HCl) 14mg, dextromethorphan (hydrobromide) 6.5mg, menthol 2mg/5ml. Syrup. 125ml, A3.93. S Dry, non-productive cough. P 10ml three or four times daily. Q Under 6 years, not recommended; 6-12 years, 5ml three or four times daily.
2 ALSO BENYLIN DRY NON DROWSY Dextromethorphan 7.5mg/5ml. Syrup. 125ml, A3.93. S Dry, non productive cough. P 10ml three or four times daily. Q Under 6 year, not recommended; 6-12 years, 5ml three or four times daily.
2 ALSO BENYLIN WITH CODEINE Diphenhydramine (HCl) 14mg, codeine phos. 5.7mg, menthol 1.1mg/ 5ml. Syrup. 125ml, A4.65. S Dry, irritating cough. P 10ml three or four times daily. Q Under 6 year, not recommended; 6-12 years, 5ml three or four times daily.
2 ALSO BENYLIN CHILDREN’S CHESTY Guaifenesin 50mg/5ml. Syrup. 125ml, A3.19. S Productive cough. Q Under 2 years, not recommended; 2-5 years, 5ml four times daily; 6-12 years, 10ml four times daily.
2 ALSO BENYLIN CHILDREN’S DRY COUGH Diphenhydramine (HCl) 7mg, menthol 0.55mg/ 5ml. Syrup. 125ml, A3.29.
S Non-productive cough. Relief of allergic conditions or reactions. Q Under 2 year, not recommended; 2-5 years, 5ml; over 6 years, 10ml. Both three or four times daily.
2 ALSO BENYLIN CHILDREN’S COUGH & COLD Dextromethorphan (hydrobromide) 5mg, triprolidine (HCl) 0.625mg per 5ml. Syrup. 125ml, A3.29. S Dry unproductive cough and rhinorrhoea associated with common cold and influenza. Q Under 2 years, not recommended; 2-5 years, 5ml three or four times daily; 6-12 years, 10ml three or four times daily.
0 ALSO BENYLIN 4 FLU Diphenhydramine (HCl) 12.5mg, pseudoephedrine (HCl) 22.5mg, paracetamol 500mg per tab. or 10ml liquid. Tablets-24, A5.19; Liquid-200ml, A5.19. S Relieves congestion, fever, cough and body pains associated with flu symptoms. P 2 tabs. or 20ml liquid four times daily; max. 8 tabs. or 80ml liquid in 24 hrs. Q Under 6 years, not recommedned; 6-12 years, half adult dose.
0 ALSO BENYLIN DUAL ACTION CHESTY Pseudoephedrine (HCl) 30mg, guaiphenesin 100mg/5ml. Syrup. 100ml, A4.00. S Cough and upper respiratory congestion. P 10ml four times daily. Q Under 2 years, not recommended. 2-5 years, 2.5ml. 6-12 years, 5ml. Both three times daily.
2O ALSO BENYLIN MUCUS RELIEF Carbocisteine 250mg/5ml. Syrup. 125ml, A3.72; 200ml, A4.56.
0 ALSO BENYLIN DUAL ACTION DRY SYRUP Triprolidine (HCl) 1.25mg, pseudoephedrine (HCl) 30mg, dextromethorphan (hydrobromide) 10mg/ 5ml. Linctus. 100ml, A4.00. S Excessive or viscous mucus in the respiratory tract. P Initially 15ml three times daily then 10ml three times daily. Q 6-12 years, 5ml three times daily. 2-5
PRESCRIBING NOTES COUGH PREPARATIONS Cystic fibrosis is characterised by thick, purulent secretions, which obstruct the airways. Dornase alfa is a genetically engineered version of a naturally occurring human enzyme, which splits extracellular DNA removing the excessive secretions and thereby improving lung function. Mucolytics which breakdown the viscosity of the sputum, are restricted (acetylcysteine is restricted to use in abdominal complications in cystic fibrosis patients, carbocisteine is restricted for treatment only in patients under 18 years with a tracheostomy). Preparations available to relieve coughs include antitussives, which reduce the sensitivity of the cough centre, though they may also reduce respiration and should be used with caution in patients with obstructive airways disease. Most of the compounds are opiate derivatives with side effects that include constipation and the potential for abuse; dextromethorphan and pholcodine have fewer side effects. Sedating antihistamines (diphenhydramine) are often used in compound preparations where their sedative qualities can be exploited. Expectorants are used in coughs to increase removal of secretions by producing a more productive cough; they include ammonium chloride, ipecacuanha, and guaiphenesin. Demulcents include syrups and glycerol, which have a soothing action and may be useful for dry and irritating coughs. Antihistamines and sympathomimetics are used as decongestants in many compound cough preparations; they should be used with caution in patients taking other medication especially those taking MAOIs and tricyclics due to interactions. Inhalations of volatile oils added to hot water, is a simple, but useful treatment to relieve congestion. References available on request.
262
years, 5-10ml daily in divided doses. Under 2 years, not recommended. D Dextromethorphan: MAOIs, risk of respiratory failure. Dual Action: See Actifed. Clear Action: Active peptic ulcer. 4 Flu: Severe hypertension or severe hyperthyroidism. With codeine: Hepatic or respiratory failure.
BISOLVON
Boehringer Ing.
2O Expectorant. Bromhexine (HCl) 4mg/5ml. Oral soln. 250ml, A3.01. S Bronchitis and other conditions where sputum is troublesome. P 10-20ml three or four times daily. Q 5-10 years, 5ml four times daily; under 5 years, 5ml twice daily. B Gastric ulcer. Fructose intolerance.
CASACOL
Helsinn Birex
0 Sympathomimetic/expectorant. Methoxyphenamine HCl 20mg, guaiphenesin 100mg, Na+ citrate 200mg per 5ml. 125ml, A3.21. S Cough. P 5-10ml three or four times daily. Q 2-3 years, 1.5-2.5ml; 3-6 years, 2.5-5ml; 6-12 years 5ml. All three to four times daily. D Coronary thrombosis, hypertension, hyperthyroidism, closed-angle glaucoma. Pregnancy, lactation. B Heart disease, urinary retention. C MAOIs, digitalis, sympathomimetics.
CODINEX
Pinewood
2K Opiate. Codeine (phos.) 15mg/5ml. Linctus. 100ml, A4.05; 150ml, A5.75; 500ml, A10.85; 2L, A34.65. S Unproductive cough. P 5-7.5ml 3 or 4 times daily. Q Under 5 years, not recommended; 5-12 years, 2.5ml 3 or 4 times daily. D Liver disease, ventilatory failure. Pregnancy, lactation, unless essential. B Driving or operating machinery. Debilitated patients, elderly (reduce dose). C CNS depressants, anticholinergics, hydroxyzine, methadone (potentiation). Alcohol, hypnotics, anxiolytics (enhance sedative effect). A Constipation, loss of appetite, dizziness, sputum retention, respiratory depression.
DELSYM
Bayer HealthCare
2 Antitussive. Dextromethorphan (resin complex equiv. dextromethorphan hydrobromide) 30mg/ 5ml. Susp. 89ml, A6.46. S Cough. P 5ml, twelve hourly, max. 15ml in twenty four hours. Q 6-12 years, 5ml twelve hourly, max. 10ml daily. 2-5 years, 2.5ml twelve hourly, max. 5ml daily; under 2 years, not recommended. B Persistent or chronic cough. Excessive secretions. Pregnancy. A Drowsiness may occur.
ERDOTIN
Galen
2NO Mucolytic Erdosteine 300mg. Hard cap. with green cap and yellow body. 20, A7.65. S Acute exacerbations of chronic bronchitis. P 300mg twice daily for up to max. 10
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY
COUGH
days. Swallowed whole with water. Q Under 18 years, not recommended. D Severe liver failure, no data. Active peptic ulcer. B Mild liver failure (300mg/day max.). Pregnancy, no data. Lactation, not recommended.
EXPUTEX
PREPARATIONS
11.2
B History of peptic ulcer. Pregnancy. A GI distress. Nausea. Rash.
yrs) 2.5-5ml. All up to three times daily.
NON-DROWSY SINUTAB
ALSO PARACODIN TABLETS Dihydrocodeine hydrogen tartrate 10mg. White tab. marked with
2NO
McNeil Healthcare star. 20, A2.90.
0K
Shire Analgesic/decongestant. Paracetamol 500mg,
pseudoephedrine (HCl) 30mg. Round biconvex tabs. 15, A3.29. S Symptomatic relief of mucous membrane congestion accompanied by mild/ moderate pain or pyrexia e.g.common cold, influenza, sinusitis, nasopharyngitis. P 2 every 4-6 hours, up to 4 times daily. Max. 8 daily. Q Over 12 years, as for adult; 6-12 years, 1 every 4-6 hours, up to 4 times daily. Max. 4 daily; under 6 years, not recommended. D Severe hypertension, severe CAD. B Mild/moderate hypertension, heart disease, hyperthyroidism, raised intraocular ILVICO Seven Seas pressure, enlarged prostate. Severe hepatic impairment, moderate/severe renal impairment. 2 Analgesic/antihistamine. Paracetemol 250mg, Ca++ Pregnancy (if benefit outweighs risk), lactation (no data). ascorbate 36mg, caffeine monohydrate 10mg, C TCADs, sympathomimetics, MAOIs, brompheniramine maleate 3mg. White, round, furazolidone. Hypotensives which interfere with biconvex sugar-ctd tab. 20, A4.17. S Common cold, influenza and upper RTIs. sympathetic activity (bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alphaV Over 12 years: 1 or 2 tab. with water 3 and beta-adrenergic blocking agents. times daily. A CNS excitation. W 6-12 years and elderly: 1 tab. two or four times daily with water. NUROFEN COLD & FLU D Narrow angle glaucoma, Reckitt Benckiser tachyarrhythmias, G6PD deficiency. Pregnancy, lactation. Children Q 6 years. 0K B Impaired liver/renal function. Contains NSAID/sympathomimetic. Ibuprofen 200mg, antihistamine. Driving or using machines. pseudoephedrine (HCl) 30mg. Yellow film-ctd tab. Pregnancy, lactation (unless clearly necessary). 12, A3.46; 24, A5.85. C Hypnotics, antiepileptics, propantheline, S Symptoms of cold and influenza incl. metoclopramide, chloramphenicol, warfarin, aches and pains, headache, fever, sore throat, coumarin, AZT, salycamide, analgesics, blocked nose and sinuses. tranquillisers, alcohol, MAOI’s, TCAs. V Under 12 years: contra. Over 12 years: A Drowsiness, dizziness, ataxia, Initially 2, then 1-2 every four hours. Max. 6 in paraesthesia, headache, restlessness. twenty-four hours. D Stomach ulcer (or history of), other GI KARVOL Reckitt Benckiser disorders. History of asthma, rhinitis, urticaria 2 associated with aspirin or other NSAIDs. Cardiovascular disease, hypertension, diabetes, Volatile oils. Levomenthol 36.55mg, chlorbutol 2.25mg, thymol 3.15mg, terpineol 66.6mg, pumilio phaeochromocytoma, closed angle glaucoma, pine oil 103.05mg, pine oil sylvestris 9mg. Inhalent prostatic enlargement. B Asthma, renal, cardiac or hepatic soln. in cap. 12, A2.22. impairment. Elderly. Pregnancy, lactation. S Congestion of respiratory tract. C Contra: MAOIs (or within 14 days), V Under 3 months not recommended; over 3 months, express contents into hot water or sympathomimetics, TCAs. Not recommended: Warfarin, heparin, guanethidine, reserpine, handkerchief and inhale vapour. Avoid contact methyldopa, quinidine. Caution: Zidovudine, antiwith the skin. hypertensives, diuretics, cardiac glycosides, lithium, MUCODYNE sanofi-aventis methotrexate, cyclosporin, NSAIDs, corticosteroids, aminoglycosides, probenocid, oral hypoglycaemics. 2O Mucolytic. Carbocisteine 250mg/5ml; syrup. 100ml, A GI disorders, headache, dizziness, muscle weakness, palpitations, tremors, acute renal A1.39; 250ml A3.48; 300ml, A2.04. failure, liver disorders, haematopoietic disorders. S Excessive or viscous mucus, glue ear in Exacerbation of bronchospasm. Restlessness, children. insomnia, hearing disturbance, anxiety, P 750mg three times daily reducing to hallucinations, chest pain, thirst. 500mg three times daily. Q Use paed. syrup.
2O
Mucolytic. Carbocisteine 250mg/5ml. Orange flavoured, sugar-free linctus. 100ml, A0.75; 300ml, A1.87; 200ml, A3.97 (OTC trade price). S Excessive or viscous mucus. P Initially 15ml three times daily reducing to 10ml three times daily. Q 2-5 years: 2.5ml two or three times daily. 6-12 years: 5ml two or three times daily. D Active peptic ulcer. B History of peptic ulcer. Pregnancy. A GI distress. Nausea. Rash.
2O
PARACODIN
ALSO MUCODYNE CAPSULES Carbocisteine 375mg yellow cap. marked MUCODYNE 375. 30, A3.71; 120 A14.82. P Initially 2 three times daily reducing to 1 four times daily. Q Use paed. syrup. D Active peptic ulcer.
Opiate. Dihydrocodeine hydrogen tartrate 12.1mg/ 5ml. Syrup. 100ml, A5.87. S Cough suppressant. P 5-10ml up to three times daily. Q Infants (over 12 months) 1.25ml; young children (2-5 yrs) 1.25-2.5ml; older children (6-12
2N
P 1-3 three times daily. Q Not recommended.
2N ALSO PARACODIN DROPS Dihydrocodeine hydrorhodanide 10mg/g. Drops. 15g, A2.90. P 14-20 drops or more if required several times daily. Q Under 12 months, not recommended; infants over 12 months, 3 drops 1-3 times daily; younger children (2-5 yrs), 3-6 drops 1-3 times daily; older children (6-12 yrs), 6-12 drops several times daily. D Respiratory depression, obstructive airways disease, opiate addiction. B Chronic hepatic disease. Renal insufficiency. Allergies, hypothyroidism. Pregnancy. Elderly. Asthma. C Alcohol, CNS depressants, MAOIs. A Constipation, nausea, vomiting, headache, dizziness, drowsiness, allergic reactions.
PHOLCODEX
Pinewood
2K Morphine derivative. Pholcodine 5mg/5ml. Oral soln with citrus flavour. 150ml, A5.25; 2L, A27.20. S Non-productive cough. P 10ml every 3-4 hrs. Q 1-6 years, 2.5ml every 3-4 hrs; 6-12 years, 5ml every 3-4 hrs. D Pregnancy (unless essential). B Contains fructose and Sunset Yellow. Driving or operating machines. A Drowsiness, nausea.
PULMOZYME
Genentech/Roche
2NT Recombinant human deoxyribonuclease. Dornase alfa 2.5mg/2.5ml. Plastic amp. containing 2500 U (2.5mg) per 2.5ml admin. by compressed air-driven nebuliser. 6, A171.00. S Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and to improve pulmonary function. P 2.5mg once daily by inhalation. Patients over 21 years may benefit from a twice daily dosage. B Pregnancy, lactation. A Pharyngitis, voice changes, chest pain, occasionally laryngitis, rashes, urticaria, and conjunctivitis.
ROBITUSSIN CHESTY COUGH Wyeth Healthcare
2K Expectorant. Guaiphenesin 100mg per 5ml; sugarfree liquid. 100ml, A4.32. S Cough. P 10ml four times daily. Q Under 2 years, not recommended; 2-6 years, 2.5ml; 6-12 years, 5ml. Both four times daily.
Teofarma 0 K
ALSO ROBITUSSIN PLUS Guaiphenesin 100mg, pseudoephedrine (HCl) 30mg per 5ml; suger-free liquid. 100ml, A4.32. S Cough with congestion. P 10ml three times daily. Q Under 2 years, not recommended; 2-6 years, 2.5ml ; 6-12 years, 5ml. Both three times
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
263
11.3 RESPIRATORY daily.
Mucolytic. Methyl cysteine (HCl) 100mg. yellow sug-ctd tab. 100, A18.33. S Chronic bronchitis, viscid or excessive mucus. P 2 three or four times daily for 6 weeks then 2 twice daily. Q Under 5 years, not recommended; over 5 years, 1 three times daily. B Pregnancy. A GI distress.
2K ALSO ROBITUSSIN DRY COUGH Dextromethorphan hydrobromide 7.5mg/5ml; sugar-free liquid. 100ml, A4.32. S Dry persistent cough. P 10ml three or four times daily. Q 6-12 years, 5ml three or four times daily; under 6 years, use Junior liquid. C MAOIs. A Rarely dizziness, GI upset.
SUDAFED
RESPIRATORY
STIMULANTS
McNeil Healthcare
0 Sympathomimetic. Pseudoephedrine (HCl) 60mg. Reddish-brown, circular, biconvex, film-ctd tab. marked Sudafed. 12, A3.21; 24, A5.32.
0 ALSO SUDAFED ELIXIR Pseudoephedrine (HCl) 30mg/5ml. Red liquid. 100ml, A3.41. S Nasal, sinus and upper respiratory congestion. P 1 tab. or 10ml every 4-6 hours up to 4 times daily. Q Under 2 years, not recommended; 2-5 years, 2.5ml; 6-12 years, 5ml. Both every 4-6 hours up to 4 times daily. Over 12 years; tab or liq as per adults. D Severe hypertension, coronary artery disease, risk of developing respiratory failure. B Hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure, prostatic enlargement. Severe hepatic impairment, moderate/severe renal impairment. Contain sucrose. Pregnancy, lactation. C MAOIS, furazolidone (both contra). Caution: TCAs, sympathomimetic agents, bretylium, guanethidine, debrisoquine, methyldopa, a- and b-adrenergic blockers, halogenated anaesthetics.
SUDAFED NASAL SPRAY McNeil Healthcare
2 Sympathomimetic. Xylometazoline (HCl) 0.1% w/v. Nasal spray soln. 1, A2.75. S Nasal, sinus and upper respiratory congestion. P One spray in each nostril 2-3 times daily. Max. 3 sprays daily. Use more than 7 consecutive days not recommended. Q Under 6 years, not recommended. D MAOIs, hypophysectomy or surgery exposing dura mater. B Coronary artery disease, hypertension, hyperthyroidism, diabetes mellitus. Pregnancy.
BACTROBAN NASAL
GSK
2NO
Topical broad spectrum antibiotic. Mupirocin 2%. Nasal oint. 3g, A6.11. S Nasal carriage of staphylococci, incl. methicillin resistant S. aureus. V Apply to the anterior nares two or VISCOLEX SYRUP Pinewood three times daily for 5-7 days. 2O D Pregnancy. Mucolytic. Carbocisteine 250mg/5ml syrup. 100ml, BECONASE A&H A3.35; 250ml, A3.48. S Lower respiratory tract disorders 2KO characterised by excessive viscous mucus. AQUEOUS NASAL SPRAY. Corticosteroid. P Initially 15ml three times daily, reducing Beclomethasone dipropionate 50mcg per dose. to 10ml three times daily. Aqueous susp. in metered dose nasal spray. 200Q 2-5 years, 2.5ml, two or three times dose unit, A2.33. daily, 6-12 years, 5ml, two or three times daily. S Prophylaxis and treatment of perennial B Pregnancy, history of peptic ulcer. and seasonal allergic and vasomotor rhinitis. Delay recurrence of nasal polyps after nasal 11.3 RESPIRATORY STIMULANTS polypectomy. CUROSURF Chiesi P 2 applications in each nostril twice daily. Alternatively, 1 application in each nostril three or 2N four times daily. Max. 400mcg (8 sprays). Lung surfactant. Poractant alfa 80mg/ml; susp. in Q Under 6 years, not recommended. single-dose vials. 120mg/1.5ml, A530.00; 240mg/ B Untreated nasal infection. Caution 3ml, A1060.00. when transferring patients from systemic steroids. 2N History of, or existent tuberculosis. Patients with ALSO CUROSURF Poractant alfa 80mg/ml; susp. in immunosuppression. Long-term use. Pregnancy, A single-dose vials. 120mg/1.5ml, 530.00; 240mg/ lactation. 3ml, A1060.00. S Treatment of respiratory distress BETNESOL UCB syndrome (RDS) in newborn premature infants 2MO with a birthweight of 700g or greater. Prophylaxis Corticosteroid. Betamethasone Na+ phos. 0.1%. in premature infants between 24 and 31 weeks Drops. 10ml, A1.53. gestational age at risk from RDS or with evidence S Non-infected inflammatory nasal of surfactant deficiency, where the mother has conditions. not received appropriate ante-natal 2NO corticosteroids. ALSO BETNESOL-N NOSE DROPS Betamethasone P See SPC. Na+ phos. 0.1%, neomycin sulph. 0.5%. Drops. B Stabilise babyâ&#x20AC;&#x2122;s general condition. 10ml, A1.56. Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is recommended. S Inflammatory conditions where infection is present or suspected. V 2-3 drops in each nostril two or three 12.1 NASAL PREPARATIONS times daily. AVAMYS GSK D Viral, fungal or tuberculous conditions. B Prolonged use. Pregnancy, lactation. 2NO Corticosteroid. Fluticasone fuorate, 27.5mcg/spray. A Nasal irritation, dryness, sneezing, headache, lightheadedness, urticaria, nausea, Nasal spray, suspension. 1 pack (120 sprays), epistaxis, rebound congestion, bronchial asthma, A11.38. perforation of the nasal septum. Sensitisation, S Allergic rhinitis symptoms. cross resistance to neomycin; avoid unnecessary P 12 years and over: Initially, 2 sprays in use. each nostril once daily (total daily dose, 110mcg);
once control achieved, reduce to 1 spray in each nostril (total daily dose, 55mcg) for maintenance. Novartis Consumer Titrate to lowest possible dose. Q 6 to 11 years: Initially, 1 spray in each 2 nostril once daily (total daily dose, 55mcg). If Expectorant. Guaifenesin 50mg per 5ml; Clear, symptoms not controlled, consider 2 sprays in each almost colourless solution with a blackcurrant nostril (total daily dose, 110mcg); reduce to 1 flavour. 100ml, A3.19. spray once control achieved. Under 6 years: Safety S Chesty coughs. Helps loosen mucus to and efficacy not established. make breathing easier. B Caution: Severe liver disease, change in Q Under 2 years, do not use; 2-5 years, vision, history of IOP, glaucoma/cataracts, 5ml; 6-10years, 5-10ml. All doses to be taken 4 prolonged treatment (systemic effect). Monitor hourly. No more than 6 doses in 24 hours. height of children receiving prolonged treatment. C Cough suppressants (not Caution when transferring from systemic steroid recommended). treatment. Contains benzalkonium chloride. Pregnancy, lactation (only if benefits outweigh VISCLAIR Sinclair risks). 2OY C Not recommended: Ritonavir. Caution:
TIXYLIX CHESTY COUGH
264
Potent CYP3A4 inhibitors. A Epistaxis (adults and adolescents, more frequent in longer-term use), nasal ulceration.
FLIXONASE
A&H
2MO Corticosteroid. Fluticasone propionate 0.05% metered dose nasal spray. 120-dose unit, A5.24. S Prophylaxis and treatment of seasonal allergic rhinitis and perennial rhinitis. P 2 sprays in each nostril once daily in the morning; max. 4 sprays in each nostril daily. Q Under 4 years, not recommended; 4-11 years, 1 spray in each nostril daily; max. 2 sprays in each nostril daily. B Pregnancy, lactation. Caution when transferring patients from systemic steroids. A Irritation of the nasal mucosa, epistaxis, taste and smell disturbances.
NASACORT
sanofi-aventis
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OTOLARYNGOLOGY nasal spray. 100-dose, A4.40. S Prevention and relief of nasal congestion, sneezing and a runny, itchy nose due to hayfever and other seasonal allergic conditions. P Initially 2 sprays twice daily into each nostril or 1 single spray into each nostril 3 or 4 times daily; max. 8 sprays in 24 hours. If symptoms under control, reduce to 1 spray twice daily into each nostril. Use minimum dose which maintains effective symptom control. Q Under 18 years, not recommended. B Systemic effects of nasal corticosteroids may occur (particularly at high doses for prolonged periods). Caution when transferring from systemic steroids. Clinically significant adrenal suppression may occur at higher than recommended doses. Monitor height of children NASEPTIN NASAL CREAM Alliance receiving prolonged treament. Concomitant therapy to control eye symptoms may be necessary 2NO during heavy allergen challenge. Treat infections Antibacterial. Chlorhexidine (DiHCl) 0.1%, of nasal passages and paranasal sinuses neomycin (sulph.) 0.5%. Cream. 15g, A2.44. appropriately. Pregnancy, lactation. S Staphylococcal infections and carriage in A Dryness and irritation of nose and the nose. throat. V Apply small amount to inside of each nostril. Prophylaxis, twice daily; eradication, four NASOFAN AQUEOUS Teva times daily for 10 days. 2MO B Prolonged use can lead to ototoxicity Glucocorticosteroid. Fluticasone propionate 50mcg and nephrotoxicity. per 100mcL metered spray. Nasal spray. 120 dose C Soap and anionic agents. unit, A7.43. S Prophylaxis and treatment of seasonal NASOBEC Teva allergic rhinitis (incl. hay fever) and perennial 2MO rhinitis. Corticosteroid. Beclometasone dipropionate 50mcg P 2 sprays into each nostril once a day per 100mg spray; aqueous nasal spray. 200-dose, (200mcg) preferably in the morning. In some cases, A3.48. 2 sprays into each nostril twice a day (max. daily S Perennial and seasonal allergic rhinitis. dose). Maintenance, 1 spray per nostril once a day. Vasomotor rhinitis. Max. relief may only be obtained after 3-4 days. P 2 sprays twice daily into each nostril or Q 4-11 years: 1 spray into each nostril 1 single spray into each nostril three or four times once a day (100mcg), preferably in the morning. daily; max. 8 sprays in 24 hours. In some cases, 1 spray into each nostril twice a day Q Under 6 years, not recommended; over (max. daily dose). Under 4 years, not 6 years, same as adult. recommended. 2K B Impaired adrenal function (caution ALSO NASOBEC ALLERGY Beclometasone when transferring patients from systemic steroid dipropionate 50mcg per 100mg spray. Aqueous treatment). Monitor height of children. Pregnancy,
2NO
Corticosteroid. Triamcinolone acetonide 55mcg per dose. Unscented nasal spray, susp. 120-dose unit, A11.65. S Seasonal and perennial allergic rhinitis. P Initially 2 sprays per nostril once daily. Maintenance, 1 spray per nostril once daily. Q Under 6 years, not recommended; 6-12 years, 1 spray per nostril once daily. Severe symptoms 2 sprays per nostril once daily. Not recommended for long term use in children. B Pregnancy, lactation. Caution when transferring patients from systemic steroids, untreated nasal infection. A Epistaxis, nasal irritation, dry mucous membranes, naso-sinus congestion, sneezing.
PRESCRIBING NOTES ALLERGIC RHINITIS The main indication for nasal sprays and drops is allergic rhinitis. Mild cases of allergic rhinitis respond to treatment with nasal corticosteroids or oral antihistamines. More persistent symptoms and also nasal congestion can be treated with topical nasal corticosteroids, sodium chromoglycate and topical nasal antihistamines. For seasonal allergic rhinitis (hayfever) treatment should be prophylactic and commenced 2-3 weeks before allergen is airborn. Antihistamines (azelastine), which decrease the inflammatory response by blocking the action of histamine on the surrounding tissues, are especially useful in relieving the symptoms of allergic rhinitis and hayfever, such as itching and sneezing. Sodium chromoglycate acts by inhibiting the allergic response; its action is not normally as effective as the antihistamines and corticosteroids but it is useful for the treatment of children. Corticosteroids (beclomethasone, betamethasone, budesonide, flunisolide, fluticasone, mometasone, triamcinolone), which suppress the allergic response and reduce inflammation, are one of the most effective treatments for nasal allergy. There is a risk of systemic absorption, especially with prolonged use or use of high doses. They should not be used in pregnancy or by children under the age of 5 years. Patients suffering severe allergic reaction may require a short course of oral treatment. Sympathomimetic drugs (tramazoline, oxymetazoline, xylometazoline) act by constricting the blood vessels and reducing the thickness of the nasal mucosa. They relieve nasal congestion by improving the drainage of the sinuses and clearing the eustachian tube opening. Their use should be controlled due to the possibility of rebound congestion on withdrawal. These preparations can cause hypertensive crisis for patients also taking MAOIs. Elimination of nasal staphyloccal infection can be achieved using a cream combining chlorhexidine and neomycin or mupirocin, which is also indicated for treatment of MRSA. References available on request.
NASAL
PREPARATIONS
12.1
lactation (if benefit outweighs risk). C Avoid potent CYP3A4 inhibitors (eg. ketoconazole, ritonavir). A Epistaxis, headache, unpleasant taste or smell, nasal and throat dryness/ irritation.
NASONEX
Schering-Plough
2NO Corticosteroid. Mometasone furoate 50mcg per dose; metered-dose pump nasal spray. 140-dose unit, A14.65. S Treatment and prophylaxis of seasonal allergic rhinitis, treatment of perennial rhinitis. Nasal polyps in adults (18 years and older). P Allergic rhinitis: 2 sprays in each nostril once daily. If necessary increase to 4 sprays in each nostril once daily. Reduce to 1 spray in each nostril once daily when controlled. Prophylaxis, start treatment 2-4 weeks before pollen season. Nasal polyposis: Initially 2 sprays in each nostril once daily. If not controlled after 5-6 weeks, increase to 2 sprays in each nostril twice daily; reduce once controlled. If no improvement after 5-6 weeks of twice daily dose, consider alternative. Q Under 6 years, not recommended; 6-11 years, one spray in each nostril once daily. D Untreated nasal infections, nasal surgery or trauma. B Tuberculous infections of the respiratory tract, untreated infections or ocular herpes simplex. Caution when transferring from systemic steroids. Monitor height of children receiving prolonged treatment. Pregnancy, lactation. A Headache, pharyngitis, epistaxis, nasal irritation/ ulceration.
OTRIVINE
Novartis Consumer
2 Sympathomimetic. Xylometazoline (HCl) 0.1%; drops and spray. Drops-10ml, A2.53; spray-10ml, A2.70. S Nasal congestion of acute rhinitis, cold and flu. P 2-3 drops or 1 spray in each nostril two or three times daily. Q Not for use in infants or children under 12 years.
2 ALSO OTRIVINE CHILDREN’S NASAL DROPS Xylometazoline Hydrochloride 0.05% w/v. Nasal drops. 10ml, A2.36 S Nasal decongestant for relief of the symptoms of acute rhinitis in allergic or upper respiratory tract infections, including the common cold or influenza. Q 2 to 12 years: 1 or 2 drops into each nostril once or twice daily; not more than 2 doses in any 24 hours. D MAOIs (within 14 days). Acute coronary disease, cardiac asthma, hyperthyroidism or closed angle glaucoma. trans-sphenoidal hypophysectomy or surgery exposing the dura mater.Children under 2 years. B Caution: Hypertension, cardiovascular disease, enlarged prostate, diabetes. May cause rebound congestion and drug induced rhinitis. Do not exceed recommended dose. Avoid prolonged use. Not to be taken with any other cough and cold medicine. Pregnancy (unless essential). C Some anti-hypertensives (b-blockers), tricyclic and tetracyclic antidepressants. A Burning sensation in nose and throat. Local irritation, nausea, headache, dry nose.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
265
12.2 OROPHARYNGEAL
OTOLARYNGOLOGY
PREPARATIONS Analgesic. Choline salicylate 8.7%, cetalkonium Cl 0.01%, ethanol (96%) 33.45%, menthol 0.057%,
RHINOCORT TURBOHALER
AstraZeneca glycerin 4.6%; gel. 15g, A3.00.
2MO
Corticosteroid. Budesonide metered dose dry powder inhaler; 100mcg per dose. 200 dose, A20.37. S Seasonal and perennial allergic rhinitis, vasomotor rhinitis and nasal polyps. P Rhinitis: 2 applications in each nostril once daily in the morning.Nasal polyps: 1 application in each nostril morning and evening. Q Not recommended. B Pregnancy. Fungal, viral or tuberculous infections. A Sneezing, nasal dryness, slight haemorrhagic secretion.
S Infant teething, mouth ulcers and sores, cold sores, denture irritation. P Massage approx. half inch of gel not more than once every three hours. Q Under 4 months, not recommended; over 4 months, massage approx. quarter inch not more than once every three hours; max. 6 doses in twenty four hours.
promote gingival healing. Useful in the management of aphthous ulceration and oral candidal infections (e.g. denture stomatitis and thrush). Q Under 12 years, only use if recommended by a healthcare professional. V Rinse with 10ml for 1 min. twice daily.
2
ALSO CORSODYL GEL Chlorhexidine gluconate 1%; gel. 50g, A1.93. S Inhibition of the formation of dental plaque. Adjunct in treatment and prevention of BYFLUC Ergha gingivitis. Adjunct in maintaining oral hygiene. For use in a post-periodontal surgery or treatment 2MO Triazole. Fluconazole 50mg, 150mg. Opaque caps; regimen to promote gingival healing. Useful in the management of recurrent aphthous ulceration 50mg, light blue cap/ white body;150mg, light and recurrent oral candidal infections. As part of a blue cap and body. 50mg-7, A7.54; 150mg-1, preventative programme to help reduce caries A3.19. RHINOLAST Meda S Oropharyngeal candidiasis, chronic oral activity. Q Under 12 years, only use if 2MO atrophic candidiasis (denture sore mouth). P 50mg once daily for 7-14 days or longer recommended by a healthcare professional. Antihistamine. Azelastine (HCl) 0.1%; metered V Brush teeth thoroughly with one inch (oropharyngeal) or for 14 days (chronic-atrophic). pump nasal spray. 20ml (approx. 136 actuations), of gel on a moistened toothbrush, once or twice A13.57. Renal impairment: See section 8.2. daily for about one minute. Q Same max. dose as adults. S Perennial and seasonal allergic rhinitis. B For oral use only, do not swallow. If D Pregnancy (unless essential), lactation. P One actuation per nostril twice daily. Q Under 5 years, not recommended; over B Discontinue if symptoms of liver disease soreness, swelling or mouth irritation occur, stop use and consult healthcare professional. Reduce develop. Rash; discontinue if develops (dermal 5 years, same as adults. consumption of tea, coffee and red wine to help infection), or monitor closely and discontinue if B Pregnancy, lactation. prevent tongue/teeth discoloration. If contact with bullous lesions or erythema multiforme develop A Nasal irritation, taste disturbance. eyes occurs, wash thoroughly with water . (invasive/systemic infection). Long-term use. C Anionic agents. RINATEC Boehringer Ing. C Contra: Terfenadine (if ByFluc dose A Local irritation, discoloration of tongue r400mg/d), cisarpide. Caution: Coumarin-type 2MO or teeth, taste changes. anticoagulants, sulphonylureas, HCTZ, phenytoin, Anticholinergic. Ipratropium bromide 21mcg per rifampicin, ciclosporin, theophylline, terfenadine, metered dose; (CFC-free) pump spray. 15ml (180DAKTARIN McNeil Healthcare astemizole or other P450 substrates, zidovudine, doses) unit and nasal applicator, A4.91. 2MO tacrolimus, rifabutin, benzodiazepines. S Symptomatic relief of rhinorrhoea and A Headache, rash, GI disorders. Hepatic Imidazole anti-fungal. Miconazole 20mg per g; non-allergic rhinitis. toxicity incl. rare cases of fatalities, elevated oral gel. 40g, A2.91. P 2 sprays in each nostril two or three alkaline phosphatase, bilirubin, SGOTand SGPT. S Fungal infections of oropharynx. times daily. P 2.5ml (50mg) four times daily. Retain Q Under 12 years, not recommended. CARBOSAN Rowa gel in mouth. B Avoid contact with eyes. Narrow-angle Q Under 1 year, 1.25ml (31mg) four times 2 glaucoma (monitor for signs). Caution with daily; over 1 year, same as adult. prostatic hyperplasia, bladder-outflow obstruction, Cytoprotectant. Carbenoxolone Na+ 2%; gel. 5g, B Pregnancy. A3.30. GI mobility disorders. Pregnancy, lactation. A Mild GI upset. C Caution: Other anticholinergics. S Lip sores and mouth ulcers. Herpes A Nasal drying, epistaxis, blurring of simplex infections. Reckitt Benckiser vision, headache, nausea, local irritation. P Apply thickly to lesions four times daily, DEQUACAINE 2 Pharyngitis, sinusitis. preferably after meals and at bedtime. Q Under 3 years, not recommended; over Local anaesthetic/anti-bacterial. Benzocaine 10mg, VIVIDRIN Dr. Mann 3 years, same as adults. dequalinium Cl 0.25mg. lozenge. 24, A2.73. S Severe sore throat. 2O CORLAN UCB V Over 12 years: 1 sucked 2 hourly as Mast cell stabiliser. Sodium cromoglycate 2 %; required. 2MO aqueous nasal spray. 15ml, A4.33. S Allergic rhinitis (perennial), seasonal Corticosteroid. Hydrocortisone (as Na+ succinate) DIFFLAM ORAL RINSE Meda allergic rhinitis, hay fever. 2.5mg pellet marked CORLAN and EVANS. 20, 2 V Prophylactic and therapeutic, one spray A1.62. into each nostril four times daily. S Aphthous ulceration. Analgesic, anti-inflammatory. Benzydamine (HCl) A Transient nasal irritation. V 1 dissolved in the mouth, in contact 0.15%. Soln. 300ml, A5.56. with ulcer, four times daily. S Painful inflammatory conditions of the 12.2 OROPHARYNGEAL PREPARATIONS D Untreated oral infection. mouth and throat. B Pregnancy, lactation. See SPC. P Rinse or gargle 15ml every 1 to 3 hours. ANBESOL SSL Healthcare Q Not recommended.
2K
CORSODYL
Local anaesthetic/antiseptic. Lidocaine (HCl) 0.9%, chlorocresol 0.1%, cetylpyridinium Cl 0.02%, ethanol 68.239%. sln 6.5ml, A2.72; 15ml, A4.57. S Mouth ulcers, sore gums. P Apply to affected area 3-4 times daily. Q Under 10 years, not recommended. B If no improvement in 3 days, consult doctor or dentist.
2
BONJELA 2K
266
GSK 2 Y
Antibacterial. Chlorhexidine gluconate 0.2%. Aniseed or mint flavoured soln. 300ml, A2.87. S Inhibition of the formation of dental plaque. Adjunct in treatment and prevention of gingivitis, and in the maintenance of oral hygiene, particularly in situations where toothbrushing cannot be adequately employed (e.g. following oral surgery or in physically or mentally Reckitt Benckiser handicapped patients). Also for use in a postperiodontal surgery or treatment regimen to
ALSO DIFFLAM SPRAY Benzydamine (HCl) 0.15%. Soln. in metered dose pump. 30ml, A4.47. P 4-8 puffs every 1-3hours. Q Under 6 years, 1 puff per 4kg body weight; max. 4 puffs every 1-3 hours; over 6 years, same as adult. A Oral numbness, pruritus rash, uticaria, photodermatitis. Rarely laryngospasm, brochospasm.
DIFLAZOLE
Pinewood
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OTOLARYNGOLOGY 2MO Triazole. Fluconazole 50mg, 150mg, 200mg. Green-white, yellow and white capsules resp. 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, A51.60. S Oropharyngeal candidiasis, chronic oral atrophic candidiasis (denture sore mouth). P 50mg once daily for 7-14 days; max. 14 days except in severely immunocompromised. Associated with dentures, 50mg once daily for 14 days admin. concurrently with local antiseptic. Renal impairment: See section 8.2. Q Over 4 weeks: 3mg/kg daily; 6mg/kg may be used on day 1. Neonates: 1st two weeks of life, 3mg/kg daily but given every 72 hrs; max.12mg/kg every 72 hrs. 3rd and 4th weeks of life, same dose but given every 48 hrs; max. 12mg/ kg every 48 hrs. D Pregnancy, lactation. B Discontinue if liver disease, rash (superficial infection) or bullous lesions/erythema multiforme (systemic infection) occur. Exfolliative cutaneous reactions, toxic epidermal necrolysis (AIDS patients). C Terfenadine or cisapride (contraindicated). Caution: Anticoagulants, benzodiazepines, sulphonylureas, HCTZ, phenytoin, rifampicin, ciclosporin, theophylline, zidovudine, rifabutin, tacrolimus, other substrates of cyt P450. A Headache, rash, GI disorders.
OROPHARYNGEAL PREPARATIONS 12.2 C Cisapride, terfenadine, anticoagulants, oral hypoglycaemics, phenytoin, rifampicin, benzodiazepines, cyclosporin, theophylline, tacrolimus, rifabutin. A GI disorder, headache, anaphylaxis, rash, dizziness, seizures, alopecia, exfoliative skin disorders, dyspepsia, vomiting, hepatitis, leucopenia, neutropenia, agranulocytosis, thrombocytopenia, angioedema, face oedema, pruritus, urticaria.
FLAGYL
chronic-atrophic oral candidiasis associated with dentures. P Oropharyngeal candidiasis: 50mg once daily. If severe, may be increased to 100mg once daily. Duration: 7-14 days (may be prolonged in severe immunocompromised patients). Chronicatrophic candidiasis: 50mg once daily during 14 days. Q Under 16 years, not recommended except in case of no therapeutic alternative. 3mg/ kg daily. 6mg/kg may be used on day 1.
sanofi-aventis 2 M O
ALSO FLUCOL SOLUTION Fluconazole 2mg/ml. Soln for inf. in 100ml vial. 1 vial, A30.90. S Recurrent oropharyngeal candidiasis. V Over 1 month of age; as per caps. Neonates, same dose as children (max. 12mg/kg) but admin. every 72 hrs (1st two weeks) or 48 hrs (weeks 3 and 4). 2MO D Pregnancy. ALSO FLAGYL-S ORAL SUSPENSION Metronidazole benzoate 200mg/5ml. Susp. 100ml, B Development of abnormal liver test values (monitor closely). Proarrhythmic conditions A6.17. S Acute ulcerative gingivitis. Acute dental eg. QT prolongation, cardiomyopathy, sinus bradycardia, arrhythmias. Caps. contain lactose. infections. P Gingivitis: 600mg daily in divided doses Lactation (use only as single 200mg dose). C Contra: Drugs known to prolong QTfor 3 days. Dental infections: 600-800mg daily in interval and metabolised by CYP3A4, eg. cisapride, divided doses for 3-7 days. Q Gingivitis: Over 10 years, as per adult. 7- terfenadine, astemizole, pimozide, quinidine and halofantrine. Caution: Other substrates of CYP3A4 10 years, 300mg daily in 3 divided doses. 3-7 years, or CYP2C9 (sulphonyl urea, phenytoin, losartan, 200mg daily in 2 divided doses. 1-3 years, 150mg celecoxib, fluvastatin, anticoagulants), HCTZ, in 3 divided doses. All for 3 days. D Active or chronic severe Peripheral and rifampicin, nevirapine, amitriptyline, didanosine, DIFLUCAN Pfizer Central Nervous System diseases. theophylline, trimetrexate, zidovudine, amphotericin B. 2MO B Peripheral or central neuropathy. A Skin rash, headache, GI upset, increase Leucopenia. Transient epileptiform seizures. Antifungal. Fluconazole 50mg. Blue/white cap. of AST, ALT and alkaline phosphatase. Monitor during prolonged use. Hepatic coded FLU 50 and PFIZER. 7, A7.75. insufficiency or encephalopathy. Alcohol. Removed 2MO Servier during haemodialysis. Fructose intolerance. Elderly. LOCABIOTAL ALSO DIFLUCAN ORAL SUSP. Fluconazole 50mg, 2NO 200mg/5ml. White powder which yields an orange Darkens urine. Pregnancy, lactation. C Phenytoin, phenobarbital, Anti-inflammatory/antibiotic. Fusafungine 500mcg flavoured susp. 50mg/5ml-35ml, A19.85; 200mg/ anticoagulants, disulfiram, lithium, cyclosporin, 5per dose in metered dose pump. 50-dose unit, plus 5ml-35ml, A79.40. fluorouracil, busulfan. nasal and oral adaptors, A1.88. S Oropharyngeal candidiasis incl. that A GI distress, furred tongue, unpleasant S Upper respiratory tract infection and occurring in immunocompromised patients. inflammation. Atrophic oral candidiasis associated with dentures. taste. Rash, urticaria, flushing, angioedema, CNS P 1 spray orally and/or in each nostril four P 50mg once daily for 7-14 days or longer disturbances, headache, dizziness, confusion, hallucinations, vision and blood disorders. hourly. if required. Atrophic candidiasis, 50mg daily for 14 Q Under 30 months, not recommended; days. Treatment may exceed 14 days in the FLUCOL Rowex over 30 months, 1 spray orally and/or in each immunocompromised. nostril 6 hourly. Q Neonates, 3mg/kg every 72 hours, aged 2 M O B Pump should be primed before the first 2-4 weeks, 3mg/kg every 48 hours; over 4 weeks, Triazole. Fluconazole 50mg, 150mg, 200mg. Hard 3mg/kg daily. caps. 50mg, turquoise/white; 150mg, white/white; use. D Pregnancy. 200mg, purple/white. 50mg-7, A12.84; 150mg-1, MEROCAINE SSL Healthcare B Impairment in hepatic or renal function, A5.48; 200mg-7, A51.26 2K S Recurrent oropharyngeal candidiasis, lactation. Local anaesthetic/antiseptic. Cetylpyridinium chlor. PRESCRIBING NOTES 1.4mg, benzocaine 10mg; green lozenge. 24, A2.53. OROPHARYNGEAL PREPARATIONS S Relief of pain and discomfort in the Povidone iodine preparations used to treat mucosal infections, should not be used over prolonged periods mouth. due to possible systemic absorption of iodine. Antiseptic solutions including chlorhexidine, hexetidine are P 1 dissolved in mouth every two hours; useful in gingivitis and other oral infections. Systemic administration of metronidazole is also indictated for max. 8 in 24 hours. acute ulcerative gingivitis. Treatment of ulceration and inflammation can include the use of gargles and Q Under 12 years, not recommended. mouthwashes. Other treatments include the use of a mechanical protectants such as carmellose and D Hypersensitivity to the active carbenoloxone, which provide a physical barrier over the ulcer to relieve discomfort but can be difficult to ingredients. apply. Corticosteroids (triamcinolone, hydrocortisone) are an effective treatment of some forms of B If symptoms persist, are severe, or are ulceration; systemic administration reserved for severe conditions. Local analgesics (lidocaine, choline accompanied by fever, headache, nausea and salicylate) have a more limited role in ulcer treatment but can provide some local pain relief; choline vomiting consult a doctor. salicylate can cause irritation and salicylate poisoning if used excessively. Lozenges containing antiseptics C None known. and analgesics are available to treat sore throats and mouths are of dubious clinical benefit but may provide A Allergic reactions, metHbaemia. symptomatic relief for patients. Preparations for the treatment of dry mouth and pharynx are based on Sensitisation. carmellose salts or similar compounds and resemble artificial saliva. Antifungals (nystatin, amphotericin,
2MO
Nitromidazole. Antibacterial. Metronidazole 200mg, 400mg. Off-white film-ctd tab. and offwhite cap. shaped film-coated tab. Both marked with name and strength. 200mg-21, A1.00; 250, A11.79; 400mg-14, A1.41; 100, A10.04.
miconazole) are indicated for fungal infection of the mouth including Candida albicans. Fluconazole and itraconazole taken orally are also indicated for the treatment of oropharyngeal candidiasis. References available on request.
MEROCETS
SSL Healthcare
2K Antiseptic. Cetylpyridinium Cl 1.4mg Lozenge 24,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
267
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Monthly Index of Medical Specialities Ireland
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MIMS Ireland
Anniv e
OTOLARYNGOLOGY
OROPHARYNGEAL PREPARATIONS 12.2
A2.33.
sunlight or UV (discontinue if phototoxicity occurs). Possibility of oesophageal irritation and ulceration, pseudomembranous colitis, anaphylaxis. C Drug/food containing bi- or tri-valent ions, eg. alum., zinc, Ca++, magn., iron, activated charcoal, cholestyramine, bismuth chelates, sucralfate, didanosine; take 2-3 hours following doxycycline. Avoid isotretinoin, penicillin, betalactam antibiotics. Caution: Hepatotoxic drugs, METRONIDE Clonmel methoxyflurane, quinapril, sulfonylurea oral antidiabetics, anticoagulants, oral contraceptives, 2MO CYP3A4 inducers, ciclosporin, chronic alcohol Antibacterial. Metronidazole 200mg. White tab. abuse. scored and coded MZL 200 and white scored tab. A Headache, common cold, flu symptoms, coded MZL400. Both marked with twin triangle sinusitis, coughing, bronchitis, infection, logo on reverse. 200mg-21, A1.62. periodontal abscess, tooth disorder, sore throat, GI S Acute ulcerative gingivitis. P 600mg daily in divided doses for 3 days. disorders, rash, joint, back and tooth pain, menstrual cramps, accidental injury. Q Under 1 year, not recommended; 1-3 years, quarter adult dose; 3-7 years, v tab. twice SPORANOX Janssen-Cilag daily; 7-10 years, half adult dose; over 10 years, as 2MO for adults. B Pregnancy, lactation, liver disease. Azole antifungal. Itraconazole 100mg. blue/ C Alcohol, cimetidine, lithium, oral anti transparent cap. and pink body, size 0. 15, A26.04. coagulants, phenobarbitone. A GI distress, furred tongue, unpleasant S Onychomycosis, systemic mycoses, taste. Urticaria, angioedema, CNS disturbances, pityriasis versicolor, dermatophytoses, oral dark urine. Neuropathy, epileptiform seizures and candidosis. vulvovaginal candidosis. leucopenia on long term therapy. P Onychomycosis, 200mg once daily for 3 months or 2 pulse treatments for fingernail MYCOSTATIN ORAL BMS infections or 3 pulse treatments for toenail infections. A pulse treatment consists of 2 caps. 2MO (200mg) twice daily for 7 days. Pulse treatments Antifungal. Nystatin 100 000 units/ml. Ready are separated by a 3-week drug-free interval. mixed susp. 30ml with dropper, A2.91. Pityriasis versicolor, 200mg once daily for 7 days. S Oral and oesophageal candidosis. Tinea corporis, tinea cruris, 100mg once daily for 2 V 1ml four times daily held in contact weeks. Tinea pedis, tinea manuum, 100mg once with lesions. Continue for 48 hours after clinical daily for 4 weeks. Fungal keratitis, 200mg once cure to prevent relapse. daily for 3 weeks. Oral candidosis, 100mg once B Should not be used for systemic daily for 2 weeks. Vulvovaginal candidosis 200mg mycoses. Pregnancy, lactation. twice daily for 1 day or 200mg once daily for 3 A Rarely oral irritation or sensitivity, days. nausea. W Not recommended. S Symptomatic relief of sore throats. Minor irritations of the mouth and throat. V Over 6 years, 1 lozenge sucked three hourly or as required. Allow lozenge to dissolve slowly in mouth A Rare urticaria, burning sensation of the mouth.
ORABASE
BMS
2 Mucoprotectant. Carmellose Na+, pectin and gelatin, equal parts in Plastibase; oint. 30g, A1.89. S Protection for lesions of oral mucosa. V Cover the affected area with a thin film; do not rub in.
ORALDENE
McNeil Healthcare
2 Antiseptic. Hexetidine 0.1%; soln. 200ml (liq and icemint), A2.96. S Oral thrush, gingivitis, stomatitis, aphthous and dental ulcers, halitosis. V Rinse mouth or gargle with 15ml two or three times daily. A Local irritation.
PERIOSTAT
Alliance
2M Tetracycline. Doxycycline (hyclate) 20mg. White round tabl. marked PS-20. 56, A 24.07. S Adult periodontitis, as adjunct to supraand sub-gingival scaling and root planing. P 20mg twice daily, at least 1 hr before meals or before bedtime. Swallow tab. whole with at least 100ml of water in upright sitting or standing position. Duration, 3 months. Q Up to 12 years, contraindicated. D Achlorhydria. Pregnancy, lactation. B Predisposition to oral candidosis, hepatic impairment, myasthenia gravis. Avoid excessive
2MO ALSO SPORANOX ORAL SOLUTION Itraconazole 10mg/ml. Soln. 150ml, A59.80. S Oral and oesophageal candidiasis in HIV-positive or immunocompromised patients. Prophylaxis of deep fungal infections anticipated to be itraconazole-susceptible, in patients with haematological malignancy or undergoing bone, marrow transplant and expected to become neutropenic (when standard therapy inappropriate). P 200mg once daily or 100mg twice daily for 1 week. Repeat if necessary. In fluconazole resistant patients up to 400mg daily may be taken for 2 weeks and repeated if necessary. W Not recommended. D Pregnancy-contraception must be used during, and for one menstrual cycle after treatment. Lactation. B CHF or history of: Use only if benefit outweighs risks. CHF risk increases with total daily dose. Transient LV ejection fraction may occur. Caution: Hepatic, renal impairment. Monitor liver function, patient should report signs of hepatitis; if occurs stop immediately. Discontinue if neuropathy occurs. Oral solution not recommended for severe neutropenia. Transient or permanent hearing loss may occur. Not recommended: Fructose intolerance, glucosegalactose malabsorption, sucrase-isomaltase insufficiency. C Contraindicated: Astemizole, bepridil, cisapride, dofetilide, levacetylmethadol
(levomethadyl), mizolastine, pimozide, quinidine, sertindole, terfenadine, CYP3A4 metabolized HMG-CoA reductase inhibitors (e.g. atorvastatin, lovastatin, simvastatin), triazolam, oral midazolam, ergot alkaloids (e.g. dihydroergotamine, ergometrine, ergotamine, methylergometrine), eletriptan, nisoldipine. Caution: CYP3A4 metabolised calcium channel blockers (e.g. dihydropyridines, verapamil), oral anticoagulants, HIV protease inhibitors (ritonavir, indinavir, saquinavir), busulfan, docetaxel, trimetrexate, vinca alkaloids, ciclosporin, tacrolimus, rapamycin (sirolimus), budesonide, dexamethasone, fluticasone and methylprednisolone, digoxin , cilostazol, disopyramide, carbamazepine, buspirone, alfentanil, alprazolam, brotizolam, midazolam IV, rifabutin , ebastine, repaglinide, fentanyl, reboxetine, halofantrine, loperamide. A Hypokalemia, headache, dizziness, nausea, GI disturbances, hepatitis, jaundice, hyperbilirubinaemia, increased hepatic enzymes, rash, pruritus, oedema.
STREPSILS
Reckitt Benckiser
2 Antibacterial. Dichlorobenzyl alcohol 1.2mg, amylmetacresol 0.6mg. Flavoured lozenges. Original, honey and lemon, vitamin C-24, A2.59; strawberry sugar free- 16, A2.33; sore throat blocked nose- 24, A2.73; cool- 24, A2.73. S Minor infections of mouth and throat. V 1, two to three hourly.
2 ALSO STREPSILS INTENSIVE Flurbiprofen 8.7mg. Honey & lemon flavoured lozenges. 16, A3.92. S Symptomatic relief of sore throats. V Under 12 years, not recommended; over 12 years, 1 sucked every 3-6 hours as required. Max. 5 in 24 hours.
2 ALSO STREPSILS EXTRA Hexylresorcinol 2.4mg. Blackcurrant lozenge. 24, A2.73. S Relief of sore throat and its associated pain. V Under 6 years, not recommended; over 6 years, 1 sucked every 3 hours as required. Max. 12 in 24 hours.
2 ALSO STREPSILS PLUS Dichlorobenzyl alcohol 1.2mg, amylmetacresol 0.6mg, lidocaine HCI 10mg. Blackcurrant lozenge. 24, A3.06. S Relief of mouth and throat infections including severe sore throat. V Under 12 years, not recommended; over 12 years, 1 sucked every 2 hours as required. Max. 8 in 24 hours.
2 ALSO STREPSILS PLUS SPRAY Dichlorobenzyl alcohol 0.446%, amylmetacresol 0.223%, lidocaine HCI 0.6%. Oromucosal spray. 20ml, A4.81. S Relief of throat infections including severe sore throat. P 2 sprays, if necessary,every two hours, up to 8 times daily. Q Not recommended. D Strepsils Intensive only: History of peptic ulcer, bronchospasm, rhinitis, or urticaria associated with aspirin or other NSAIDs. B Asthmatics. Pregnancy, lactation. Strepsils Intensive only: Renal cardiac and hepatic impairment. C Strepsils Intensive only: Fresemide, anticoagulants. A Strepsils Intensive only: Abdominal pain,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
269
12.3 AURAL
OTOLARYNGOLOGY
PREPARATIONS
nausea, vomiting, diarrhoea, dyspepsia, GI bleeding, peptic ulceration, rash. Very rarely thrombocytopenia.
12.3 AURAL PREPARATIONS
BETNESOL
UCB
occur. Phototoxicity may occur; avoid excessive sunlight. May result in overgrowth of nonsusceptible organisms, including fungi. Lactation. C Theophylline, caffeine, warfarin, ciclosporin. A Otic pruritus.
2MO
EXTEROL
Corticosteroid. Betamethasone Na+ phos. 0.1%. Drops. 10ml, A1.53 S Non-infected inflammatory conditions of the ear. V 2 or 3 drops two or three hourly until control achieved then reduce frequency.
2
2NO ALSO BETNESOL-N EAR DROPS Betamethasone Na+ phos. 0.1%, neomycin sulph. 0.5%. Drops. 10ml, A1.56. V 2-3 drops three or four times daily. D Viral, fungal, tuberculous or purulent conditions. Perforated ear drum. B Prolonged use. Pregnancy, lactation. A Sensitisation, skin reactions, cross resistance to neomycin; avoid unnecessary use.
sanofi-aventis
2NO Corticosteroid/aminoglycoside/antibiotic.
Cerumenolytic. Urea hydrogen peroxide 5% in glycerin; drops. 8ml, A4.58. S Removal of ear wax. V Instil up to 5 drops and retain in ear. Use once or twice daily for 3-4 days. D Perforated ear drum. A Mild effervescence. Discontinue if causes irritation.
gramicidin 0.005%. drops. 10ml, A4.85. S Otitis externa. V Instil 2-3 drops three or four times daily. D Perforated ear drum. B Pregnancy. Avoid long-term use in infants. A Superinfection.
TROPEX
Rowa
2
GENTICIN EAR/EYE DROPS
Analgesic. Phenazone 5%. Drops. 10ml, A3.20.
Amdipharm S Otitis media. Removal of ear wax.
2NO
OTOSPORIN
V 4-6 drops 3 or 4 times daily. D Perforated ear drum.
WAXSOL
Norgine
2 Cerumenolytic. Docusate Na+ 0.5% in watermiscible base; drops. 10ml, A1.98. S Removal of ear wax. V Fill ear on 2consecutive nights before syringing. D Perforated ear drum, inflammation. A Transient irritation.
13.1 ANTI-INFECTIVE EYE PREPARATIONS
BROLENE
sanofi-aventis
2 Antibacterial. Propamidine isetionate 0.1%; benzalkonium Cl 0.01%. Sterile drops. 10ml, A4.58. S Local infections of superficial structures of eye caused by sensitive microorganisms. V 1-2 drops up to 4 times daily.
GSK 2
2NO Antibiotic/corticosteroid. Polymyxin B sulph. 10,000 units, neomycin sulph. 3400 units, hydrocortisone 1%; drops. 10ml, A4.73. S Bacterial infections and inflammation of outer ear. V Instil 3 drops three or four times daily or insert soaked wick, keeping wet.
PRESCRIBING NOTES AURAL PREPARATIONS Preparations are available for the treatment of ear infections, otitis externa, otitis media as well as preparations to soften and facilitate wax removal. Corticosteroid drops are an effective treatment for inflammation caused in otitis externa. Applications to difficult areas are possible by soaking a gauze dressing and introducing into the ear canal, positioning it against the affected area. Alternatively instil a liberal amount of solution into the ear canal, and then request the patient to lie with the affected ear uppermost to facilitate contact of the solution with the affected area. If infection is also present a topical antibiotic that is not used systemically should be used (neomycin, clioquinol) but not for a prolonged length of time due to sensitivity and the possibility of fungal infections. Acute infections can be very painful and may require systemic antibiotics and some simple analgesia. Due to reports of ototoxicity in patients with perforated tympanic membrane (eardrum) it is recommended that treatment with topical aminoglycoside antibiotics be contraindicated in patients with tympanic perforation. Local treatment of acute otitis media is ineffective as most attacks are viral in origin. Symptomatic treatment includes simple analgesia, severe bacterial infection should be treated with systemic antibiotics, and for recurrent cases prophylactic antibiotics may be required. Cerumenolytics are used to soften impacted wax to facilitate removal. References available on request.
270
SOFRADEX
Dermal Dexamethasone 0.05%, framycetin sulph. 0.5%,
Antibiotic. Gentamicin (as sulph.) 0.3%. Drops. 10ml, A2.25. S Bacterial ear infections. CERUMOL EAR DROPS L.A.B. V 2-3 drops three or four times daily and at night; more frequently if required. 2K D Perforated ear drum. Cerumenolytic. Arachis oil 57.3%, chlorbutol 5%, A Superinfection. p-dichlorobenzene 2% w/v. Ear drops in vial with separate dropper 11ml, A1.96. GENTISONE HC EAR DROPS S Removal of ear wax. Amdipharm V Instill 5 drops into ear and retain liquid. 2NO Leave for at least 20 minutes. Repeat twice daily Antibiotic/corticosteroid. Gentamicin (as sulph.) for 3 days. 0.3%, hydrocortisone acetate 1%. Drops. 10ml, D Otitis externa, seborrhoeic dermatitis, A4.63. eczema affecting external ear. Perforated S Otitis externa, chronic suppurative otitis eardrum. Allergy to peanuts. media. Post-op infected mastoid cavities. B Not to be taken internally. Do not use V 2-4 drops three or four times daily and for more than 3 days. at night. CILOXAN EAR DROPS Alcon D Perforated ear drum. B Pregnancy, lactation. Avoid prolonged 2NO use in infants. 4-quinolone. Ciprofloxacin (HCl) 3mg/ml. Clear, A Superinfection. colourless to pale yellow sln. 5ml, A4.38.
S Acute otitis externa due to ciprofloxacin-susceptible strains of bacterial species. P 4 drops twice daily. Hepatic or renal impairment: Not recommended. Q 3 drops twice daily. D Pregnancy (unless clearly nececessary). B Serious and occasionally fatal anaphylactic reactions reported rarely; discontinue if skin rash or other hypersensitivity reactions
B Limit use to 10 days if ear is perforated. Avoid long-term use in infants. A Superinfection.
ALSO BROLENE OINTMENT Dibromopropamidine isetionate 0.15%. Oint. 5g, A4.75. V Apply 1 or 2 times daily for not more than 2 days. D Use of contact lenses. B Sensitisation reactions. Visual acuity problems. Transient blurring of vision, care with driving or operating machinery. A Hypersensitivity.
CHLOROMYCETIN REDIDROPS Goldshield
2NO Broad-spectrum antibiotic. Chloramphenicol 0.5%; Eye drops. 10ml, A2.17. S Bacterial conjunctivitis.
2NO ALSO CHLOROMYCETIN OPHTHALMIC OINT. Chloramphenicol 1%. 4g, A2.17. S Bacterial conjunctivitis. R As for adults V 2 drops or 1 application of oint. three hourly or more requently if required. Admin. should be continued 48 hours after symptoms have disappeared. B Pregnancy/lactation C None known A Aplastic anaemia (rare).
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OPHTHALMOLOGY EXOCIN
ANTI-INFLAMMATORY EYE Allergan
Amdipharm
4-quinolone. Ofloxacin 0.3% w/v. Eye drops, sln 5ml, A2.58. S External ocular infections (e.g. conjunctivitis, keratoconjunctivitis) caused by ofloxacin-sensitive organisms. P 1-2 drops in the affected eye(s) 3 or 4 times daily. Duration max. 10 days. Q Not recommended. D Pregnancy (and women at risk of pregnancy), lactation. Children and adolescents before epiphyseal closure. B Not for inj. May occur: Serious hypersensitivity reactions (discontinue), StevensJohnson syndrome, corneal precipitates, photosensitivity reactions. Caution: Sensitivities to other quinolones, prolonged use (overgrowth of non-susceptible organisms), CNS disorders , epilepsy, hepatic/renal insufficiency, severe dehydration, G6PDH defects (potential haemolytic reactions), corneal epithelial defects or corneal ulcers. Ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis: Not recommended. Limited data on treatment of conjunctivitis in neonates. Contains benzalkonium chloride. Use of contact lenses not recommended. Driving/using machines. C Antacids, systemic quinolones. A Eye irritation, ocular discomfort.
2NO
FUCITHALMIC
POLYFAX
LEO Pharma
2NO Fusidic acid. Fusidic acid 1%; viscous eye drops. 5g, A2.63.
2NO ALSO FUCITHALMIC UNIT DOSE Fusidic acid 1% preservative-free; 0.2g unit dose. 12 x 0.2g, A4.03. S Bacterial infections of the eye caused by susceptible organisms. V Apply 1 drop to conjunctival sac twelve hourly, continue for 2 days after symptoms disappear. D Use with contact lenses. A Superinfection. Transient irritation. PRESCRIBING NOTES EYE INFECTIONS Eye infections that are bacterial in source can be effectively treated with broad spectrum topical antibiotics. Chloramphenicol is widely used for superficial eye infections and is well tolerated. Other broad spectrum antibiotics include, framycetin, neomycin, lemofloxacin and also ciprofloxacin, ofloxacin and gentamicin, though these last three are not effective against Pseudomonas aeruginosa infections. Chlortetracycline is indicated for chlamydial infections but systemic treatment may also be necessary to eliminate the source of the infection in the genito-urinary tract. Fusidic acid is of use in infections caused by staphylococcal organisms. Acycolvir is indicated for Herpes simplex infections. It needs to be started as soon as possible to have maximum effect. Herpes zoster ophthalmicus is more effectively treated using oral and intravenous routes. References available on request.
Aminoglycoside. Gentamicin (as sulph.) 0.3%. Drops. 10ml, A2.25. S Ocular bacterial infections. V 1-2 drops six times daily. More frequently if required. A Transient irritation, superinfection.
Mast cell stabilisers. Lodoxamide (tometamol) 0.1%. Sterile drops. 10ml, A5.79. S Treatment of allergic conjunctivitis. P 1-2 drops in each eye four times daily. Q Under 4 years, not recommended; over 4 years, same as adult. B Pregnancy, lactation. Soft contact lenses. A Mild transient irritation of eyes.
BETNESOL
MINIMS CHLORAMPHENICOL 2NO
13.2
2MO
GENTICIN EYE/EAR DROPS
2NO
PREPARATIONS
UCB
2MO
Chauvin Corticosteroid. Betamethasone Na+ phos. 0.1%.
Broad-spectrum antibiotic. Chloramphenicol 0.5%, preservative free; single dose eye drops. 20, A5.93. S Ocular bacterial infections. P 1 or more drops as required. Q 1 drop as required. B Remove contact lenses. C Chymotripsin. A Local hypersensitivity reactions (discontinue immediately). Aplastic anaemia (rare).
Drops. 10ml, A1.53. S Non-infected inflammatory conditions. V 1-2 drops into the eye every one to two hours.
2NO
ALSO BETNESOL-N EYE DROPS Betamethasone Na+ phos. 0.1%, neomycin sulph. 0.5%. Drops. 10ml, A1.56. V 1-2 drops to each affected eye up to six times daily. D Viral, fungal, tuberculous or purulent MINIMS GENTAMICIN Chauvin infections. Dendritic ulcer. Glaucoma. Soft contact lenses. 2NO B Prolonged use. Pregnancy, lactation. Aminoglycoside. Gentamicin (as sulph.) 0.3%, A preservatice free; single dose eye drops. 20, 6.93. A Rise in IOP, corneal thinning, cataract, mydriasis, ptosis, epithelial punctate keratitis. S Ocular bacterial infections. Sensitisation and cross resistance to neomycin; V 1 drop up to 4 times daily. avoid unnecessary use. B Sulphacetamide. C Sulphacetamide.
EMADINE
Alcon
Teva 2 N O
Antihistamine. Emedastine (as difumarate) 0.5mg; drops. 5ml, A9.72. S Seasonal allergic conjunctivitis. P 1 drop instilled into affected eye(s) twice daily. Q Under 3 years, not recommended; over 3 years, same as adult. D Renal or hepatic impairment. Elderly. ZOVIRAX GSK Pregnancy, lactation. B Ocular corneal infiltration; discontinue 2NO immediately. Do not insert contact lenses until 10Antiviral. Aciclovir 3%. Oint. 4.5g, A12.54. 15 mins. after instillation. S Herpes simplex keratitis. A Transient irritation, blurred vision, V Insert 1cm into lower conjunctival sac oedema, headache, rhinitis, pain. five times daily at 4 hourly intervals. Continue for min. 3 days after healing. FML LIQUIFILM Allergan A Mild stinging. Superficial punctate 2MO keratitis. Corticosteroid. Fluorometholone 0.1% (w/v). Eye 13.2 ANTI-INFLAMMATORY EYE drops. 5ml, A2.04. S Non-infected inflammatory ocular PREPARATIONS conditions. ACULAR Allergan Q Under 2 years, safety not established. V Over 2 years, 1-2 drops into conjuntival 2MO sac two to four times daily. NSAID. Ketorolac (trometamol) 0.5%. Sterile soln. D Viral (e.g. keratitis dendritica, varicella5ml, A8.08. zoster infections), bacterial (e.g. tuberculosis) and S Prophylaxis and reduction of fungal infections of the eye. Pregnancy, lactation inflammation following ocular surgery. (unless clearly necessary). P One drop instilled into eye 3 times daily B Not for use q 1 week except under starting 24 hours before surgery and continuing specialist surveillance and regular IOP for 3 or 4 weeks. measurements. May aggravate herpes simplex Q Not recommended. virus infections. Contains benzalkonium chloride; D Sensitivity to acetylsalicylic acid and avoid contact with soft contact lenses. Remove other NSAIDs. contact lenses before use; wait for at least 15 min B Coagulagion disorders. Soft contact before reinsertion. Adverse topical effects of lenses. Pregnancy, lactation. steroid treatment may occur on facial skin. Admin A Transient stinging, burning and ocular concomitant ocular medication 5 min prior to irritation. Blurring and diminished vision. FML. If transient blurring of vision occurs, wait before driving/operating machines. ALOMIDE Alcon A Increased IOP, eye irritation,
2NO
Peptide antibiotics. Polymyxin B sulph. 10,000 units, bacitracin zinc 5000 units per gram. Oint. 4g, A2.95. S Styes, conjunctivitis, blepharitis and keratitis. V Apply two or more times daily.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
271
13.2 ANTI-INFLAMMATORY
OPHTHALMOLOGY
EYE PREPARATIONS
conjunctival hyperaemia, eye pain, visual disturbance, foreign body sensation in eyes, eyelid/ eye oedema, blurred vision, eye discharge, eye pruritis, increased lacrimation, ocular hyperaemia, mydriasis, eye inflammation, corneal disorder, cataract (including subcapsular), rash, hypertension.
haemorrhage, pain, vitreous floaters, retinal haemorrhage, IOP increased, vitreous detachment, intraocular inflammation, irritation, cataract, foreign body sensation, visual disturbance, blepharitis, subretinal fibrosis, hyperaemia, visual acuity blurred/decreased, dry eye, vitritis, discomfort, posterior capsule opacification, retinal exudates, inj. site reactions, lacrimation increased, HAY-CROM AQUEOUS EYE pruritis, conjunctivitis, maculopathy, retinal DROPS Teva pigment epithelium detachment, endophthalmitis, retinal detachment/tear and iatrogenic traumatic 2OY cataract. Headache, nausea, arthralgia, back pain, Mast cell stabiliser. Sodium cromoglycate 2%; bronchitis, anaemia, elevated BP. drops. 13.5ml, A4.75. S Prophylaxis and treatment of acute and MACUGEN Pfizer chronic allergic conjunctivitis incl. hay fever and 2J seasonal kerato-conjunctivitis. V 1-2 drops into each affected eye up to Modified oligonucleotide. Pegaptanib (Na+) four times daily. 1.65mg (equiv. 0.3mg free acid form of D Soft contact lenses. oligonucleotide). Sln for inj. in vial. 1, A640. A Transient burning or stinging. S Neovascular (wet) age-related macular degeneration (AMD). LUCENTIS Novartis P One intravitreal inj. every six weeks into 2J affected eye. Monoclonal antibody. Ranibizumab, 10mg/ml. Soln Q Under 18 years, not recommended. A D Active or suspected ocular or periocular for inj. 1- 0.3ml vial, 1100. infection. Lactation. S Neovascular (wet) age-related macular B History for hypersensitivity reactions. degeneration. Use adequate anaesthesia and broad-spectrum P Recommended dose: 0.5mg. Initial topical microbicide prior to inj. Monitor: Perfusion loading phase: 1 inj/month for 3 consecutive of optic nerve head and IOP; endophthalmitis (2 months; then maintenance phase: Monitor for weeks following inj.). Pregnancy (only if benefit visual acuity monthly, if loss q 5 letters, admin. dose. Interval between 2 doses r1 month. Patient outweighs risk). Driving/using machines if blurred vision. should self-admin. antimicrobial drops 4 times daily for 3 days before and after each inj. A Eye disorders, eg. anterior chamber Q Not recommended. inflammation, eye pain, increased intraocular D Active or suspected ocular or periocular pressure, punctate keratitis, vitreous floaters, infections. Active severe intraocular inflammation. vitreous opacities. Headache, rhinorrhea. B Intravitreal inj only. Monitor for: Infections during week following inj.; IOP and MAXIDEX Alcon perfusion of optic nerve head. Bilateral treatment, 2 M O previous intravitreal inj.; not studied. Potential for Corticosteroid/lubricant. Dexamethasone 0.1%, immunogenicity. Do not admin. with other antihypromellose 0.5%; drops. 5ml, A1.83. VEGF agents. Withhold dose until next scheduled S Inflammation of anterior segment. treatment in event of: Decreased best-corrected V 1-2 drops hourly for 3-4 days. visual acuity of r30 letters; IOP r30mmHg; 2MO retinal break; subretinal haemorrhage involving ALSO MAXIDEX OINTMENT Dexamethasone 0.1%. fovea centre, or, if haemorrhage size r50% of 3g, A2.29. total lesion area; or a performed or planned V Apply small amount up to 4 times daily, intraocular surgery within previous or next 28 reducing gradually to once daily for several days. days. If rhegmatogenous retinal detachment or D Viral, fungal, tuberculous or purulent stage 3 or 4 macular holes, discontinue. infections. Glaucoma. Soft contact lenses. Pregnancy, lactation; not recommended. If visual B Prolonged use in pregnancy or infants. disturbances occur, do not drive or use machines A Rise in intra-ocular pressure, corneal until resolved. thinning, A Eye disorders: Conjunctival PRESCRIBING NOTES ANTI-INFLAMMATORY EYE PREPARATIONS Corticosteroids are used topically to reduce inflammation of the anterior segment including that induced by surgery. They should be used under supervision as there are risks of significant side effects. They interfere with the local defence mechanisms of the eye and can lead to opportunistic infections; also there is the risk of steroid glaucoma through raised intraocular pressure and steroid cataract. Cushing s syndrome can occur following prolonged use in the young due to systemic absorption. Other side effects include thinning of the cornea and sclera. Non-steroidal anti-inflammatories e.g. nedocromil, ketorolac can be used to treat inflammation but with less side effects compared to the administration of corticosteroids. Antihistamines e.g. emedastine, antazoline, azelastine and levocabastine are useful in the treatment of allergic conjunctivitis. Sodium chromoglycate, nedocromil sodium and lodoxamide are mast cell stabilisers and inhibit the release of histamine from these cells in allergic conditions. They are useful in allergic conjunctivitis but are best used prophylactically. References available on request.
272
MAXITROL
Alcon
2NO Corticosteroid/aminoglycoside/lubricant/ peptide. Dexamethasone 0.1%, neomycin sulph. 0.35%, hypromellose 0.5%; polymyxin B sulph. 6000 IU/ml. Drops. 5ml, A2.15. S Infected ocular inflammation. V 1-2 drops 4-6 times daily.
2NO ALSO MAXITROL OINTMENT Dexamethasone 0.1%, neomycin sulph. 0.35%, polymyxin B sulph. 6000 IU per g. 3.5g, A1.79. V Apply three or four times daily. D Viral, fungal, tuberculous or purulent infections. Glaucoma. Soft contact lenses. B Prolonged use in pregnancy or infants. A Rise in intra-ocular pressure, corneal thinning, cataract, fungal infection.
MINIMS PREDNISOLONE
Chauvin
2MO Corticosteroid. Prednisolone Na+ phos. 0.5%, preservative free. single dose eye drops. 20, A6.93. S Non-infected inflammatory conditions. P 1-2 drops as required. Q At discretion of physician. D Viral, fungal, tuberculous or purulent infections. Glaucoma. B Should not be used for longer than one week except under ophthalmic supervision. C Decrease effect of antiviral eye preparations and anticholinesterases. A Rise in intra-ocular pressure, corneal thinning, cataract, fungal infection.
OPATANOL
Alcon
2NO Antiallergic/antihistmine. Olopatadine (HCl) 1mg/ ml. Soln. 5ml, A11.93. S Treatment of ocular signs and symptoms of seasonal conjunctivitis. P One drop in the conjuunctival sac of the effected eye(s) twice daily (eight hourly). Treatment may be maintained up to four months if necessary. Q Under 3 years, not recommended over 3 years, same a adults. B Wait 10-15 mins. after instillation before inserting contact lenses. Discontinue if signs of hypersensitivity occur. Blurred vision or other visual disturbances may affect the ability to drive. Pregnancy, lactation. A Ocular discomfort, ocular pruritus, ocular hyperaemia, ocular discharge, keratitis, dry eyes, lid oedema, foreign body sensation, photophobia, headache, asthenia, dizziness, dry nose.
OPTICROM
sanofi-aventis
2 Mast cell stabiliser. Sodium cromoglycate 2%. Drops. 13.5ml, A6.48 (GMS). S Allergic conjunctivitis. V 1-2 drops into each eye 4 times daily. D Soft contact lenses. B Discard preparation 4 weeks after opening. A Transient stinging, blurred vision.
OPTREX
Reckitt Benckiser
2 Astringent/lubricant. Distilled Witch Hazel 13%. Eye Drops. 10ml, A2.55.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OPHTHALMOLOGY
ANTI-INFLAMMATORY EYE
S Relief of mild degrees of irritation, inflammation and congestion such as may occur with allergic conjunctivitis, blepharitis, exposure to external irritants. P 1 or 2 drops into each eye, as often as required.
after excluding the presence of viral, fungal and bacterial pathogens. P 1-2 drops 2 to 4 times daily. Initially dosage may be 2 drops every hour.
2NO
ALSO PRED MILD Prednisolone (acetate) 0.12% w/ v. Eye drops. 5ml, A1.59. S Mild to moderate non-infectious allergic ALSO OPTREX EYE LOTION Distilled Witch Hazel and inflammatory disorders of the lid, conjunctiva, 13%. Eye lotion. 110ml, A3.30. cornea and sclera (incl. chemical and thermal P Fill eye bath 1/3 full and apply to open burns). eyelid for r 30 sec. Repeat with fresh lotion to P 1-2 drops 2 to 4 times daily. During other eye. Apply twice daily or as required. initial 24-48 hours, may be increased to 2 drops Q Under 3 years, not recommended. every hour. D Ulceration of the eye or obvious infection. Use with soft contact lenses (or 15 mins Q Under 2 years, not recommended. before insertion for lotion). D Acute untreated purulent ocular infections, superficial herpes simplex (dendritic OPTREX CLEAR EYES Reckitt Benckiser keratitis), vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, fungal or 2 treponemal diseases of the eye, ocular Sympathomimetic amine/astringent. Hamamelis tuberculosis. Lactation (no data), pregnancy. water 12.5%, naphazoline HCI 0.01%. Eye drops. B Do not use q 1 week except under 10ml, A3.36. strict ophthalmic supervision with regular IOP S Temporary symptomatic relief of checks. Caution: History of herpes redness of the eye due to minor eye irritations. P 1 or 2 drops into each eye, no more than 4 times daily. D Glaucoma, serious eye disease, previous eye surgery. Use with contact lenses except under medical supervision. B Caution: Use on an inflamed eye. High BP, depression, heart disease, diabetes or increased thyroid activity; consult doctor before use. Consult doctor if: Severe eye pain, changes of vision or discharge from eye, condition worsens or persists q 1 day. C Contra: MAOIs (or within 14 days). Caution: Other topically applied autonomic drugs, antihypertensives, cardiac glycosides, quinidine, TCAs.
2
OTRIVINE-ANTISTIN
PREPARATIONS
13.2
simplex,prolonged use, glaucoma. May lead to perforation in the presence of thin corneal or scleral tissue. Not effective in mustard gas keratitis and Sjogren’s keratoconjunctivitis. Acute purulent untreated infection may be masked or activity enhanced by steroids. Contains benzalkonium chloride, remove contact lenses and reinsert 15 mins after. Pred Mild contains Na+ metabisulphite. Driving/using machines (transient blurred vision). A Local irritation, rise in intra-ocular pressure, posterior subcapsular cataract, secondary infection, systemic effects with prolonged use.
RELESTAT
Allergan
2NO Antihistamine/mast cell stabiliser. Epinastine (HCl) 0.5mg/ml (equiv. 0.436mg epinastine). Drops. 5ml, A19.72. S Seasonal allergic conjunctivitis. P 1 drop instilled in affected eye(s) twice daily. Q 12 years and older, as for adults. B Remove contact lenses before application, re-insert after 15 mins. Pregnancy,
Novartis Consumer
2 Sympathomimetic/antihistamine. Xylometazoline (HCl) 0.05%, antazoline sulph. 0.5%. Clear, colourless aqueous eye drops sln. 10ml, A3.52. S Symptomatic relief of conjunctival hyperaemia and oedema associated with allergic conjunctivitis. P 1 or 2 drops, 2 to 3 times daily. R 1 drop, 2 or 3 times daily Q Under 12 years, not recommended. D Narrow angle glaucoma. Contact lenses. B Hypertension, hyperthyroidism, diabetes, coronary disease, dry eyes. Caution: Elderly patients with severe cardiovascular disease (incl. arrhythmia); hypertension; diabetes; phaeochromocytoma; conditions causing urinary retention (e.g. prostatic hypertrophy). C Contra: MAOIs. Caution: CNS depressants, other anti-muscarinics, digitalis, badrenergic blockers, guanetidine, reserpine, methyldopa, anti-hypertensives, other sympathomimetic drugs. Halogenated anaesthetic agents. A Transient stinging, tachycardia, palpitations, arrythmia, hypertension occipital headache, nausea, paleness and sweating.
PRED FORTE
Allergan
2NO Corticosteroid. Prednisolone (acetate) 1% w/v. Eye drops. 5ml-A1.78. S Short-term treatment of steroidresponsive inflammatory conditions of the eye, AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
273
13.3 GLAUCOMA
OPHTHALMOLOGY
C Caution: Other photosensitising agents. A Abnormal vision, severe vision decrease, pain, oedema, inflammation, extravasation, infSOFRADEX sanofi-aventis related back/chest pain, nausea, photosensitivity reaction, asthenia, hypercholesteraemia. Vasovagal 2NO and hypersensitivity reaction. Corticosteroid/aminoglycoside/antibiotic. Dexamethasone 0.05%, framycetin sulph. 0.5%, VIVIDRIN Dr. Mann gramicidin 0.005%; drops. 10ml, A4.85. 2O S Infected ocular inflammation. V 1 or 2 drops three or four times daily. Mast cell stabiliser. Sodium chromoglycate 2 %. D Viral, fungal, tuberculous or purulent Sterile eye drops. 13.5ml, A5.85. infections. Glaucoma. S Prevention and treatment of acute B Prolonged use in pregnancy or infants. allergic conjuntivitis (hay fever), chronic allergic A Rise in IOP, corneal thinning, cataract, conjunctivitis (inflammation) of the eye lids and fungal infection. vernal kerato-conjunctivitis (vernal or spring catarrh). VEXOL Alcon V One drop into each eye four times daily. lactation. A Burning sensation in eye.
2MO
2O
Corticosteroid. Rimexolone 1%; drops. 5ml, A5.49. S Treatment of anterioor uveitis, post operative inflammation and corticosteroid responsive inflammation of the conjunctiva, cornea and anterior segment of the globe. P Post-op. inflammation, one drop four times daily starting 24 hours after surgery and continue for 2 weeks. Steroid responsive inflammation, one drop four times or more daily for max. four weeks. Uveitis, one drop hourly during the day for first week, every two hours during second week, four times per day during third week; then twice per day during first 4 days of week four and then once daily during the last 3 days of week four. Q Not recommended. D Epithelial herpes simplex, keratitis, vaccinia, varicella and most other viral diseases of cornea and conjunctiva; micobacterial infection of the eye; fungal disease of the eye; acute purulent untreated infections. B Prolonged use may result in ocular hypertension/glaucoma, damage to the optic nerve and visual fields, posterior subcapsular cataract formations due to suppression of host response. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur. pregnancy, lactation. A Increased IOP. Posterior subcappsular cataract formation. Blurred vision, discharge, discomfort, ocular pain, foreign body sensation.
ALSO VIVIDRIN SINGLE DOSE Sodium cromoglycate 2%; sterile drops in single dose unit (preservative-free). 0.5ml x 20, A5.81. V One drop into each eye 4 times daily. D Soft contact lenses. B Discard any remaining contents four weeks after opening. A Blurring of vision especially when administered.
benefit outweighs risk). Discolours soft contact lenses. Remove contact lenses prior to application and wait 15min before reinsertion.Driving/ operating machinery. C Contra: MAOIs, antidepressants affecting NA transmission (eg. TCAs, mianserin). Caution: CNS depressants, antihypertensives, cardiac glycosides, drugs affecting circulating amines (chlorpromazine, methylphenidate, reserpine), sympathomimetics agonists or antagonists. A Eye disorders incl. allergic reactions (hyperaemia, stinging, conjunctival follicles, pruritis). Dry mouth, headache, fatigue, drowsiness, dizziness, abnormal taste, upper respiratory symptoms.
AZARGA
Alcon
3O
Carbonic anhydrase II inhibitor/b-blocker. Brinzolamide 10mg and timolol (as maleate) 5mg. Eye drops. White to off-white uniform suspension, pH 7.2. 5ml, A15.13. P 1 drop in conjunctival sac of affected eye(s) twice daily. Max dose: 1 drop twice daily. Q Under 18 years, not recommended. D Bronchial asthma, history of bronchial asthma, or severe chronic obstructive pulmonary VOLTAROL OPHTHA Novartis disease. Sinus bradycardia, 2nd or 3rd degree atrioventricular block, overt cardiac failure, or 2MO cardiogenic shock. Severe allergic rhinitis and NSAID. Diclofenac Na+ 0.1%. Drops. 5ml, A5.39. bronchial hyperreactivity; Hyperchloraemic S Inhibition of miosis in cataract surgery, post-op. inflammation. Non-infective inflammatory acidosis. Severe renal impairment. Hypersensitivity conditions of the anterior segment, inflammation to sulphonamides. Pregnancy (unless clearly necessary). following trauma, pain post-PRK surgery, B Adverse reactions as seen with systemic prophylaxis of cystoid macula oedema. b-blockers may occur (See 2.4 b-blockers Drug ZADITEN Novartis Prescribing Note). Acid-base disturbances reported. Discontinue if signs of serious reactions or 2MO hypersensitivity occur. Caution: Pseudoexfoliative Antihistamine/mast cell stabiliser. Ketotifen 0.25%. glaucoma, pigmentary glaucoma (monitoring of Eye drops. 5ml, A9.79. IOP recommended). Not recommended for S Seasonal allergic conjunctivitis. narrow-angle glaucoma. May impair mental P 1 drop twice daily. alertness and/or physical coordination in elderly. Q Under 12 years, not recommended. Careful monitoring recommended: Contact lenses D Soft contact lenses - reinsert after 15 wearers, patients with compromised corneas. mins. Contains benzalkonium chloride (monitor with B Caution in pregnancy. A Burning/stinging, blurring of vision, dry frequent or prolonged use, remove contact lenses eyes, headache, somnolence, skin rash, dry mouth, before application, wait 15 min to reinsert). May temporarily blur vision, caution if driving/ allegic reaction. VISUDYNE Novartis operating machines. C Not recommended: Concomittant oral 13.3 GLAUCOMA 2JN carbonic anhydrase inhibitors. Caution: CYP3A4 Antineovascularisation agent. Verteporfin 15mg. ALPHAGAN Allergan inhibitors, oral Ca++ channel blockers, guanethidine Powder for sln for inf. 15mg vial, A1180.46. or b-blockers, antiarrhythmics, digitalis glycosides 2MO S Exudative (wet) age-related macular or parasympathomimetics, clonidine, CYP2D6 a2-agonist. Brimonidine (tartrate) 0.2% (2mg/ml, degeneration (AMD) with predominantly classic inhibitors, antidiabetic agents. equiv. brimonidine 1.3mg/ml). Eye drops, clear subfoveal choroidal neovascularisation (CNV). A Dysgeusia, blurred vision, eye pain, eye greenish-yellow sln. 5ml, A13.17. Subfoveal choroidal neovascularisation secondary irritation, foreign body sensation in eyes. See also to pathological myopia. S Reduction of elevated intraocular 2.4 b-blockers Drug Prescribing Note. P 1st step: 10-min IV inf. 6mg/m2, diluted pressure (IOP) in open-angle glaucoma or ocular in 30ml inf. sln. 2nd step: Light activation 15 min hypertension . As monotherapy where b-blockers AZOPT Alcon after start of inf. Re-evaluated every 3 months. In contraindicated or as adjunctive therapy where 2NO the event of recurrent CNV leakage, may be given target IOP not achieved with a single agent. Carbonic anhydrase II inhibitor. Brinzolamide up to 4 times per year. P 1 drop twice daily approx. 12 hours 10mg/ml. Drops. 5ml, A10.05. Q Not recommended. apart. S Ocular hypertension, open angle D Porphyria, severe hepatic impairment. Q Under 12 years, not recommended. glaucoma as monotherapy in patients Pregnancy (unless clearly necessary), lactation. D Neonates and infants under 2 years. unresponsive to b-blockers or as adjunctive B Photosensitivity for 48 hours after inf. Lactation. therapy to b-blockers. Avoid sunlight but not ambient indoor light (help B Severe CVD. Depression, cerebral or P One drop instilled into affected eye(s) eliminate drug). Caution: Moderate hepatic coronary insufficiency, Raynaudâ&#x20AC;&#x2122;s syndrome, twice daily increase if necessary to one drop three impairment or biliary obstruction, general orthostatic hypotension, thromboangiitis anaesthesia. Unstable heart disease, uncontrolled obliterans. Renal / hepatic impairment. Children 2- times daily. Q Not recommended. arterial hypertension (no data). Driving/using 7years and/or weighing Q 20 kg: Caution, high D Hypersensitivity to sulphonamides. machines. incidence of somnolence. Pregnancy (only if
274
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OPHTHALMOLOGY benzalkonium chloride, sodium metabisulphite. Remove contact lenses prior to application; wait 15 min before reinsertion. C CNS depressants, oral Ca++ channel blockers, Rauwolfia alkaloids, guanethidine, bblockers, anti-arrhythmics, digitalis glycosides, parasympathomimetics, adrenaline, antidiabetics, quinidine, anaesthetics, iodine contrast products, BETAGAN Allergan IV lidocaine, cimetidine, chlorpromazine, methylphenidate, reserpine, prostamides, 3MO prostaglandins, a-agonists, carbonic anhydrase b-blocker. Levobunolol (HCl) 0.5%; drops with inhibitors, pilocarpine. compliance device. 5ml, A5.79, 15ml (3x5ml), A Eye irritation, conjunctival irritation, A13.88. blepharitis, conjunctivitis. 3MO ALSO BETAGAN UNIT DOSE Levobunolol (HCl) BETOPTIC Alcon 0.5%; preservative-free soln. in single dose units. 3MO 30 x 0.4ml, A10.67. S Control of intraocular pressure in Cardio-selective b-blocker. Betaxolol (HCl) 0.5%; chronic open angle glaucoma and ocular drops. 5ml, A7.34. hypertension. 3MO P 1 drop once or twice daily. ALSO BETOPTIC SUSP. Betaxolol (HCl) 0.25%. Q Not recommended. Clear, colourless to pale yellow sterile, eye drops D Reactive airway disease incl. bronchial solution. 0.25ml single dose-50, A11.61. asthma, severe COPD. Sinus bradycardia, 2nd and S Ocular hypertension, chronic open-angle 3rd-degree AV block not controlled with pace glaucoma. maker, overt cardiac failure, cardiogenic shock. P 1 drop twice daily. Pregnancy, lactation. Q Not recommended. B In angle-closure glaucoma use with a D Sinus bradycardia, cardiogenic shock, miotic. Caution: Severe / unstable and uncompensated cardiac failure, soft lenses. uncontrolled CV disease (incl. 1st degree AV B History of obstructive airways disease, block), haemodialysis, metabolic acidosis, diabetes, thyrotoxicosis. General anaesthesia. untreated phaeochromocytoma, spontaneous A Transient discomfort. Rarely decreased hypoglycaemia / uncontrolled diabetes, depression, corneal sensitivity, erythema, corneal punctate cerebral / coronary insufficiency, Raynaud’s staining, keratitis. phenomenon, orthostatic hypotension, Severe renal impairment. Hyperchloraemic acidosis. B Pseudoexfoliative glaucoma or pigmentary glaucoma, narrow angle glaucoma. Contact lenses. Diabetes. Pregnancy, lactation. A Temporary blurred vision, transient burning or stinging, foreign sensation. Bitter taste, headache.
GLAUCOMA 13.3 responsive to topical b-blockers. P 1 drop twice daily, approx. 12 hours apart. Q Children and adolescents, not recommended. D See 2.4 b-blockers Drug Presc. Notes. B See 2.4 b-blockers Drug Presc. Notes. Severe or uncontrolled CVD. Monitor, history of severe cardiac disease; if discontinuation needed, withdraw gradually. Thromboangiitis obliterans. Remove contact lenses prior to use; reinsert after 15 mins. C Contra: MAOIs (within 14 days), antidepressants affecting NA transmission (e.g. TCAs, mianserin). See 2.4 b-blockers Drug Presc. Notes. A Allergic reactions (discontinue), conjunctival hyperaemia, burning sensation, eye/ eyelid disorders, depression, somnolence, headache, hypertension, oral dryness, asthenic conditions, LFTs abnormal.
COSOPT
MSD
3MO Carbonic anhydrase inhibitor/b-blocker. Dorzolamide (HCl) 20mg/ml, timolol (maleate) 5mg/ml. Drops. 5ml, A16.81.
3MO
ALSO COSOPT PRESERVATIVE-FREE Dorzolamide (as HCL) 20mg/ml and timolol (as maleate) 5mg/ml. Eye drops. 60 x 0.2ml, A36.91. S Elevated IOP in patients with openangle glaucoma or pseudoexfoliative glaucoma when topical b-blocker monotherapy is inadequate. thromboangiitis obliterans, chronic eye P 1 drop in the affected eye twice daily. COMBIGAN Allergan inflammation and corneal dystrophy (only use in R Not recommended. D See 2.4 b-b-blockers Drug Presc. Notes. stringent diagnosis; monitor continuously), history 3 M O Severe renal impairment, hyperchloraemic acidosis. a2 adrenergic agonist/b-blocker. Brimonidine of atopy/severe anaphylactic reaction. May occur: B See 2.4 b-b-blockers Drug Presc. Notes. tartrate 2mg/ml, timolol 5mg/ml. Eye drops, clear Cardiac and respiratory reactions, choroidal A History of renal calculi, hypersensitivity to greenish-yellow soln. 5ml, 14.55. detachment (after filtration procedures). May sulphonamides. Pre-existing chronic corneal mask signs of hyperthyroidism and cause S Reduction of intraocular pressure (IOP) defects, history of intraocular surgery. Acute worsening of Prinzmetal angina, severe peripheral, in patients with chronic open-angle glaucoma or angle-closure glaucoma, no data. Soft contact central circulatory disorders, hypotension. Contains ocular hypertension who are insufficiently lenses (no data on preservative-free). C Leave an interval of 10 minutes if PRESCRIBING NOTES applying other topical ophthalmic agents. Oral bGLAUCOMA Blockers, quinidine and SSRIs. Caution: See Approved first line treatments for chronic simple glaucoma include beta-blockers and prostaglandins Prescribing Notes on b-blockers section 2.4. latanoprost and travoprost. Other 1st choice treatments include carbonic anhydrase inhibitors and A Headache, eye burning and stinging, nd selective alpha2-agonist while 2 choice agents include adrenergics, cholinergics and guanethidine. If eyelid inflammation/ irritation, ocular irritation, the first choice monotherapy alone is not effective on intraocular pressure (IOP) or not tolerated, it is sinusitis, taste perversion, nausea, fatigue. st preferable to switch to any of the other topical agents that can be initiated as monotherapy. If the 1 choice monotherapy is effective and well tolerated, but not sufficient to reach the target IOP, then the addition of any other topical agent can be initiated. Beta-blockers work by reducing aqueous humour production. They can be absorbed systemically after drainage from the eye via the lacrimal duct and transfer across the nasal mucosa. Cardioselective agents are preferable in the elderly, patients with heart disease or those with bronchial asthmas as recommended by the CSM. Prostaglandin analogues such as latanoprost or travoprost act by increasing uveoscleral outflow. They can increase the brown pigmentation in the eye so should be monitored in patients receiving treatment to only one eye, and those with mixed coloured irides. Bimatoprost is a prostamide that has been shown to be effective in patients who did not respond to latanoprost. Carbonic anhydrase inhibitors including acetazolomide, dorzolamide and brinzolamide also reduce aqueous humour production and can be used with or as an alternative to beta-blockers. Acetazolomide has low ocular penetration and must be given orally as opposed to topically. Selective alpha2 agonists such as brimonidine are used as adjunctive therapy to beta-blockers or as monotherapy in open angle glaucoma when other drugs are inappropriate. Adrenaline is a sympathomimetic (as is dipivefrin which is a pro-drug of adrenaline). It also reduces the production of aqueous humour as well as reducing its outflow. Guanethidine (adrenergic neurone blocker) is used in combination with adrenaline as it enhances and prolongs its effects; long term use should be monitored. Adrenaline is also used with pilocarpine which is a cholinergic agonist. It causes constriction of the ciliary muscle, which opens the drainage channels in the trabecular network. References available on request. Revised: May 2005
DIAMOX SR
Goldshield
5MO Carbonic anhydrase inhibitor. Acetazolamide 250mg. Sust.-release orange cap. 28, A15.44. S Glaucoma. P 1-2 daily. Q Not recommended.
5MO ALSO DIAMOX Acetazolamide 250mg. White scored tab marked Lederle 4395. 112, A15.56. P 1-4 daily in divided doses. Q Infants, v tab. daily; others: v-3 tabs daily in divided doses.
5NO ALSO DIAMOX PARENTERAL Acetazolamide Na+ 500mg. Powder in vial. 1, A20.40. V See lit. D Chronic closed angle glaucoma. Renal hyperchloraemic acidosis, adrenal insufficiency, Na+ or K+ depletion. B K+suppl. may be required. Gout,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
275
13.3 GLAUCOMA
OPHTHALMOLOGY
diabetes, pregnancy, monitor fluid, electrolytes and blood. C Folic acid antagonists. A Flushing, thirst, headache, drowsiness, polyuria paraesthesia excitement, bloody dyscrasias, rash.
GANDA 3 + 0.5%
Chauvin
2MO
Adrenergic neurone blocker/sympathomimetic. Guanethidine monosulph. 3%, adrenaline 0.5%. Sterile eye drops. 7.5ml, A8.32. S Glaucoma. DUOTRAV Alcon P 1 drop once or twice daily. Q As instructed by the practitioner. 3MO D Narrow angle glaucoma. Prostaglandin analogue/b-blocker. Travoprost B Examine conjunctiva and cornea every 6 40mcg, timolol 5mg/ml. Clear eye drops. 2.5ml, months during long term use; discontinue if A16.71. damage is seen. Pregnancy, lactation. S Decrease of IOP in patients with openC MAOIs. angle glaucoma or ocular hypertension who are A Conjunctival vasodilation, burning insufficiently responsive to topical b-blockers or sensation. Systemic effects (rare). Paradoxical rise prostaglandin analogues. in pressure, ptosis, superficial punctate keratitis. P 1 drop once daily, in the morning or evening, at the same time each day. GANFORT Allergan Q Under 18 years, not recommended. 3MO D See 2.4 b-blockers Drug Presc. Notes. Prostamide/b-blocker. Bimatoprost 0.3mg/ml, Corneal dystrophies. timolol (as maleate) 5mg/ml. Colourless eye drops. B See 2.4 b-blockers Drug Presc. Notes. 3ml, A21.29. Rarely respiratory/cardiac reactions can cause S Decrease of IOP in patients with opendeath. Caution: Diabetics, aphakia, pseudophakic, angle glaucoma or ocular hypertension who are risk factors for spontaneous hypoglycaemia, insufficiently responsive to topical b-blockers or cystoid macular oedema or iritis/uveitis. May prostaglandin analogues. change eye colour, eyelashes and cause P 1 drop once daily, in the morning. permanent heterochromia. Contains benzalkonium Q Under 18 years, not recommended. chloride, polyoxyethylene hydrogenated castor oil D See 2.4 b-blockers Drug Presc. Notes. 40. Remove contact lenses prior to use, wait 15 B See 2.4 b-blockers Drug Presc. Notes. min. to reinsert. Pregnancy (unless clearly Rarely respiratory/cardiac reactions can cause necessary), lactation. death. Caution: Diabetics, aphakia, pseudophakic, C See 2.4 b-blockers Drug Presc. Notes. known risk factors for cystoid macular oedema. A Nervousness, dizziness, headache, eye May change eye colour, eyelashes, eye lid skin disorders (See SPC), irregular heart rate, BP (may be permanent). Contains benzalkonium increase/decrease, heart rate decrease, chloride. Remove contact lenses prior to use, wait bronchospasm, urticaria, skin hyperpigmentation, 15 min. to reinsert. Monitor frequent/prolonged pain in extremity. use in dry eye patients or where cornea Beta-blockers Unless otherwise specified, beta-blockers are prohibited in-competition only in the following sports:
Aeronautic (FAI) Automobile (FIA) Billiards and Snooker (WCBS) Bobsleigh (FIBT) Boules (CMSB) Bridge (FMB) Curling (WCF) Golf (IGF) Gymnastics (FIG) Motorcycling (FIM)
IOPIDINE 0.5%
Alcon
2NO a2-adrenergic agonist. Apraclonidine (HCl) 0.5% and benzalkonium (Cl-) as preservative. 5ml, A12.29. S Short term adjunctive treatment of chronic glaucoma to delay laser treatment or surgical procedures. P 1 drop in the affecred eye(s) three times daily. Allow 5 min, interval between instillation of different medications. Q Not recommended. D History of severe, unstable or uncontrolled CVD. Soft contact lenses. B Angina, severe coronary insufficiency, recent MI, cardiac failure, cerebrovascular disease, chronic renal failure, Raynaudâ&#x20AC;&#x2122;s disease. Monitor intraocular pressure regularly. Pregnancy, lactation. C MAOIs, systemic sympathomimetic amines, CNS depressants, TCAs, b-blockers, antihypertensives, cardiac glycosides, clonidine. A Hyperaemia, pruritus, discomfort, tearing, oedema of lids and conjunctiva. Dry mouth, taste disturbamces.
LUMIGAN
Allergan
2NO Prostaglandin analogue. Bimatoprost 0.3mg/ml. Eye-drops, soln. in 3 ml bottle. 1, A16.24; 3, A38.34. S Reduction of elevated intraocular pressure in chronic open angle glaucoma and ocular hypertension as monotherapy or adjunctive therapy to b-blockers. P 1 drop in affected eye(s) once daily, in the evening. Q Under 18 years, not recommended. D Pregnancy, lactation. B Renal, respiratory impairment. Moderate to severe hepatic impairment. Patients at risk of macular oedema. Monitor dry eye patients (keratopathy). Contact lenses (remove prior to admin., wait 15min before reinsertion). A Eyelash growth, darkening of eyelids, increased iris pigmentation (warn patient). Conjunctival hyperaemia/oedema, allergic conjonctivis, asthenopia, bepharitis, cataract, corneal erosion, eyelid erythema/pruritus, ocular pruritus or irritation/discomfort, superficial punctate keratitis, visual disturbance, worsening visual acuity. Headache, elevated liver function, hypertension.
MINIMS PILOCARPINE
Modern Pentathlon (UIPM) for disiplines involving shooting
Chauvin
2MO
Ninepin and Tenpin bowling (FIQ) Powerboating (UIM) Sailing, (ISAF) match race helms only Skiing/Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snow board halfpipe/big air Wresting (FILA)
Beta-blockers are prohibited in and out of competition in the following sports: Archery (FITA)
Cholinergic. Pilocarpine nitrate 2% and 4%, preservative free; single dose eye drops. 20, A5.93. S Emergency treatment of glaucoma. As a miotic to reverse weaker mydriatics. P 1-2 drops as required. D Acute iritis, anterior uveitis. B Caution with use in inflamed eye. C Corticosteroids, anticholinergics. A Can cause spasm of the ciliary muscle. Local irritation, headache.
NYOGEL
Shooting (ISSF, IPC)
276
compromised. Pregnancy (unless clearly necessary), lactation. C See 2.4-b-blockers Drug Presc. Notes. A Eye disorders, blepharal pigmentation.
Novartis
3MO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OPHTHALMOLOGY
OCULAR
b-blocker. Timolol 0.1%; gel. 5ml, A3.19. S Ocular hypertension, chronic open-angle glaucoma. P 1 drop into each affeted eye once daily in the morning. Q Not recommended. D See 4.2 b-b-blockers Drug Presc. Notes. Corneal dystrophies, severe allergic rhinitis.
PILOGEL
Alcon
2MO Cholinergic. Pilocarpine (HCl) 4%; ophthalmic gel. 5g, A7.60. S Glaucoma. P Apply approx. 1-1.5 cm gel to lower conjunctival sac once daily at bedtime. Q Not recommended. D Acute iritis, soft contact lenses. B Corticosteroids, anticholinergics. C Corticosteroids, anticholinergics. A Temporary loss of visual acuity; warn patient. Local irritation, headache.
PROPINE
Allergan
2NO Sympathomimetic. Dipivefrin (HCl) 0.1%; drops. 10ml, A5.60; 5ml with compliance pack, A4.91; 15ml (3x5ml), A11.67. S Chronic open angle glaucoma. Ocular hypertension. P 1 drop every 12 hours. Q Not recommended. D Closed angle glaucoma. Soft contact lenses. B Narrow angles. Aphakia. A Transient stinging. Rebound hyperaemia. Allergic reactions (rare).
TIMOPTOL
MSD
3MO b-blocker. Timolol (as maleate) 0.25%, 0.5% w/v. Metered dose-0.25% x 5ml, A4.67; 0.5% x 5ml, A4.67. S Ocular hypertension, chronic open angle glaucoma, secondary glaucoma. P Initially 1 drop of 0.25% soln. twice daily changing to 0.5% soln. twice daily if required. Q Not recommended. D See 2.4 b-blockers Drug Presc. Notes. Soft lenses (metered dose and LA). B Withdraw gradually. Advise patients to report any intercurrent ocular conditions. Monitor cardiac function and treatment following filtration procedures. Diabetes. Pregnancy, lactation.
Anti-Doping Information
s This medicinal product contains substance(s) prohibited for use in specific sports only (as listed in WADA Prohibited List 2010). Athletes requesting to use this product in these specific sports are required to apply for a TUE.
LUBRICANTS
13.4
D See 2.4 b-blockers Drug Presc. Notes. B See 2.4 b-blockers Drug Presc. Notes. Latanoprost may gradually change eye colour, TRAVATAN Alcon increasing the amount of brown pigment; advise patient. Caution in inflammatory, neovascular, 2NO chronic angle closure or congenital glaucoma; in Prostaglandin analogue. Travoprost 40mcg/ml. open angle glaucoma of pseodophakic patients, Drops. 2.5ml, A16.29. pigmentary glaucoma and in closed angle S Decrease of elevated intraocular glaucoma (acute attacks). Soft contact lenses. pressure in patients with ocular hypertension or Pregnancy, lactation. open-angle glaucoma who are intolerant or C See 2.4 b-blockers Drug Presc. Notes. insufficiently responsive to other intraocular pressure lowering medications, as monotherapy or A Increased iris pigmentation. Darkening, thickening and lengthening of eyelashes. Eye as adjunctive therapy. irritation. See 2.4 b-blockers Drug Presc. Notes. P One drop in the conjunctival sac of affected eye(s) once daily preferably in the XALATAN Pfizer evening. 2NO Q Not recommended. D Pregnancy, lactation. Soft contact lenses. Prostaglandin analogue. Latanoprost 50mcg/ml. B Gradual change in eye colour. Macular Eye drops soln. 2.5ml, A17.11. oedema, incl. cystoid macular oedema. Avoid skin S Reduction of elevated IOP in patients contact. Prolonged use in dry eyes or where with open angle glaucoma and ocular cornea is compromised. Do not drive or operate hypertension. machinery if blurred vision occurs. P 1 drop in affected eye(s) once daily, A Ocular hyperaemia, ocular pruritus, preferably in the evening. irritation and discomfort, iris discolouration, Q Not recommended. photophobia, keratitis, flare, tearing, blurred D Contact lenses. Pregnancy, lactation. vision, conjunctivitis, iritis, lid oedema. B Inflammatory, neovascular, angle Hypotension, bradycardia, periorbital skin closure or congenital glaucoma, pigmentary discolouration. glaucome, open angle glaucoma in pseodophakic or aphakic patients. Patients with known risk TRUSOPT MSD factors for cystoid macular oedema or iritis/uveitis. Severe or brittle asthma. 2MO A Iris pigmentation - possible change of Carbonic anhydrase inhibitor. Dorzolamide (HCl) colour in mixed coloured irides; inform patient. 20mg/ml. Eye drops. 5ml, A10.10. Eye irritation, eyelash changes, conjunctival 2MO hyperaemia, transient punctate epithelial erosions, ALSO TRUSOPT 2% PRESERVATIVE-FREE blepharitis, macular oedema. Asthma Dorzolamide (HCL) 20mg/ml. Eye drops. 60 x exacerbation. 0.2ml, A31.04. S Ocular hypertension, open-angle 13.4 OCULAR LUBRICANTS glaucoma, pseudo-exfoliative glaucoma. Adjunctive therapy to b-blockers or monotherapy ARTELAC Dr. Mann in patients where b-blockers are ineffective or 2KO contraindicated. Lubricant/tear substitute. Hypromellose 0.32%, P 1 drop three times daily. Adjunctive sorbitol, disodium phosphate dodecahydrate, Na+ therapy, 1 drop twice daily. dihydrogen phosphate dihydrate, cetrimide, Q Not recommended. disodium edetate. Sterile drops. 10ml, A2.13. D Severe renal impairment, S Symptomatic treatment of dehydration hyperchloraemic acidosis. B Hepatic impairment, acute angle-closure of the cornea and conjunctiva. V Instill one drop into conjunctival sac 3 glaucoma. History of renal calculi. Consider discontinuation if allergic reactions occur. Caution: to 5 times daily as required. C See 2.4 b-blockers Drug Presc. Notes. Other topical and systemic b-blockers.
Pre-existing chronic corneal defects, history of intra-ocular surgery. Contact lenses: Remove before use and wait 15 min. before reinsertion; preservative-free soln, no data. Pregnancy, lactation. C Oral carbonic anhydrase inhibitors. A Headache, eye burning and stinging, superficial punctate keratitis, tearing, conjunctivitis, eyelid inflammation, itching, irritation, blurred vision, nausea, bitter taste, fatigue.
XALACOM
2O
ALSO ARTELAC SINGLE DOSE Hypromellose 0.32%, sorbitol, disodium phosphate dodecahydrate, Na+ dihydrogen phosphate dihydrate, disodium edetate. Sterile drops in single dose unit (preservative-free). 0.6ml x 30, A5.18; 0.6ml x 60, A8.88. V Preservative-free, suitable for contact lense users. Insert 3 to 5 times daily as required. B Soft contact lenses (Artelac single dose more suitable). A Blurring of vision especially when Pfizer administered.
3NO Prostaglandin analogue/b-blocker. Latanoprost 50mcg, timolol (maleate) 6.8mg (equiv. to 5mg timolol) per 1ml. Eye drops soln. 2.5ml, A22.97. S Reduction of IOP in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to topical b-blockers. P One drop in the affected eye(s) once daily in the morning. Q Not recommended.
CELLUVISC
Allergan
2OY Viscosity enhancer. Carmellose Na 10mg/ml (1% w/v). Eye drops in single dose vials. 60 x 0.4ml, A13.61. S Symptoms of dry eye. V Instil 1-2 drops into conjunctival sac. +
2OY ALSO CELLUVISC 0.5% Carmellose Na+ 5mg/ml
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
277
13.5 MYDRIATICS,
(0.5% w/v). Eye drops in single dose vials. 30 x 0.4ml, A7.52. S Tear substitute. Symptoms of dry eye. V Instil one to two drops 4 times a day or as needed. May be used with contact lenses. B Discontinue if irritation, pain, redness or changes in vision occur. Do not drive or operate machinery unless vision is clear. Celluvisc 1%: Remove contact lenses before application, re-insert after 15 mins. C Concomitant ocular medication should be admin. 15 mins prior to use. A Celluvisc 1%: Eye irritation/pain, vision blurred, tearing. Celluvisc 0.5%: Temporary burning.
GELTEARS
OPHTHALMOLOGY
ANAESTHETICS AND STAINS
Chauvin
S All forms of dry eye, particularly where S Ocular lubrication for relief of dry eyes. V One or more drops as required. lipid layer is deficient. V Admin. up to 5 times daily and at night. D Soft contact lenses.
LIQUIFILM TEARS
Allergan
TEARS NATURALE
Alcon
2O
2O
Lubricant/tear substitute. Polyvinyl alcohol 1.4% w/ v. Eye drops, colourless sln in 15ml bottle. 1, A1.99. S Lubricant and artificial tear in dry eye and other ocular irritation syndromes. V 1-2 drops as required. D Soft contact lenses. B Discontinue if eye pain, redness or change in vision for more than 72 hours. A Transient stinging or irritation.
Tear substitute. Dextran 70 0.1%, hypromellose 0.3%; drops. 15ml, A2.04. S Tear deficiencies. V 1 or 2 drops as required. D Soft lenses.
2O
LIQUIVISC
Lubricant/tear substitute. Carbomer 980 0.2%; gel. 10g, A2.68. S Dry eye conditions. V 1 drop 3-4 times daily. D Soft contact lenses.
2OY
LACRI-LUBE
MINIMS ARTIFICIAL
VIDISIC GEL
Dr. Mann
2O Tear substitute. Polyacrylic acid 0.2%, cetrimide 0.01%, sorbitol 4%, Na+ edetate 0.01%, sodium hydroxide 0.084%; aqueous gel. 10g, A2.93.
Allergan 2 O
ALSO VIDISIC SINGLE DOSE UNIT PRESERVATIVE FREE Polyacrylic acid 0.2%, sorbitol 4%, Na+ edetate 0.01%, sodium hydroxide 0.084%; acqueous gel. 30 x 0.6ml, A8.47. S Symptomatic relief of dry eyes associated with sicca syndrome. Tear deficiencies. Instil 1 drop into conjunctival sac 3-5 times or more frequently during the day and before retiring at night. D Undiagnosed conjunctivitis. Use with contact lenses. B Use 5 mins. after use of other conjunctival medications. C Use 5 mins. after use of other conjunctival medications. A Blurring of vision especially when TEARS Chauvin administered.
Tear substitute. Carbomer 974P 2.5mg/g. Slightly yellow and opalescent eye gel. 10g tube, A4.97. S Symptomatic treatment of dry eye syndrome. P Instil one drop of the gel into the ILUBE Alcon inferior conjunctival cul-de-sac 1 to 4 times daily 2NO according to the degree of ocular trouble. Q Not recommended. Lubricant/tear substitute. Acetylcysteine 5%, B Contact lenses (reinsert 30 min. after hypromellose 0.35%; drops. 10ml with dropper, A4.92. instillation). Pregnancy, lactation (not studied). C Other eye drops, wait 15 min. and instil S Dry eye syndromes particularly Liquivisc last. associated with abnormal mucous production. A Transient stinging or burning. Blurred V 1 or 2 drops three or four times daily. vision until gel is evenly distributed over eye. D Soft contact lenses. Allergan
2O
2O
Lubricant. White soft paraffin, liquid paraffin, non-ionic hydrous wool fat; preservative-free oint. 3.5g, A2.25; 5g, A2.84. S Ocular lubrication, corneal protection. V Apply small quantity as required.
Lubricant/tear substitute. Sodium Cl 0.35%, hydroxyethylcellulose 0.44%, preservative free. 20, A6.55. S Dry eye syndrome associated with deficient tear secretions. V 1-2 drops three or four times daily or as Dr. Mann required.
LIPOSIC 2KO
Lubricant/tear substitute. Carbomer 2mg/g. Also containing triglycerides. Gel. 10g, A3.38. PRESCRIBING NOTES OCULAR LUBRICANTS Are used to correct tear deficiency caused by reduced or abnormal tear secretion. Hypromellose is the most popular preparation but for the patient the frequent application may prove problematic. In comparison carbomers (polyacrylic acid), polyvinyl alcohol, polyethylene glycol and dextran preparations increase the persistence of the tear film and are especially useful when the mucin layer is inadequate and tear distribution patchy. They may be more acceptable to patients as the number of applications is reduced. Acetylcysteine is able to breakdown the mucous molecules, and is useful when there is an overproduction of mucus and in cases where surface mucin is abnormal. It is often combined in preparations with hypromellose. Sodium chloride is indicated for general eye irrigation. Eye ointments containing paraffin can also lubricate the eye. As they cause visual disturbance, they are best applied before sleep. References available on request.
278
13.5 MYDRIATICS, ANAESTHETICS AND STAINS
FLUORETS
Chauvin
2NO
Diagnostic strip. Fluorescein Na+ 1mg; impregnated strip. 100, A8.39. S Diagnostic examinations, incl. Goldmann MINIMS SODIUM CHLORIDE tonometry and contact lens fitting. Chauvin V One moistened strip stroked across eyeball. 2 Isotonic saline. Sodium Cl 0.9%, preservative free. B Use once only and discard. single dose drops. 20, A6.98. MINIMS AMETHOCAINE Chauvin S Irrigation of the eye. V As required. 2NO anaesthetic. Amethocaine (HCl) 0.5%, 1%, REFRESH OPHTHALMIC Allergan Topical preservative free. Single dose eye drops. 20, A6.55. 2Y Lubricant. Polyvinyl alcohol 1.4%, povidone 0.6%. S Topical anaesthesia for ophthalmic Soln. in unit dose vial. 30 x 0.4ml, A4.33. procedures. S Artificial tear in dry eye and other V 1 drop or as required. ocular irritation syndromes. B Protect eye from dust and V 1-2 drop in each eye as required or contamination. Corneal damage after prolonged directed. use. Hyperaemia. B Remove contact lenses before C Sulphonamides. application, re-insert after 15min. Discontinue and A Dermatitis, transient burning sensation. consult doctor if irritation, pain, redness and MINIMS ATROPINE Chauvin changes in vision occur or worsen. Driving/using machines. 2M C Admin. concomitant ocular medication Anticholinergic. Atropine sulph, 1%, preservative 15 mins. prior to use. free; single dose drops. 20, A6.98. A Transient stinging or irritation. S Mydriatic and cycloplegic.
SNO TEARS
Chauvin
2O Lubricant/tear substitute. Polyvinyl alcohol 1.4%; Eye drops. 10ml, A1.28.
V 1 drop as required. D Narrow angle glaucoma or shallow anterior chamber. B Cornea may be damaged by prolonged use. Protect eye from dust and contamination.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALLERGY
ANTI-ALLERGIC
single dose eye drops. 20, A5.93. S Diagnostic stain for locating abrasions and foreign particles, Goldmann tonometry; fitting of hard contact lenses. MINIMS BENOXINATE Chauvin V 1 or more drops as required. D Soft contact lenses. 2MO B Avoid microbial contamination. Topical anaesthetic. Oxybuprocaine (HCl) 0.4%, preservative free; single dose eye drops. 20, A5.93. MINIMS LIGNOCAINE AND S Anaesthesia of cornea and conjunctiva FLUORESCEIN Chauvin for ophthalmic procedures. 2N V 1 or more drops as required. B Cornea may be damaged by prolonged Local anaesthetic/stain. Lignocaine (HCl) 4%, use. Protect eye from dust and contamination. fluorescein Na+ 0.25%, preservative free. single Hyperaemia. dose eye drops. 20, A9.84. C Chlorhexidine acetate. S Ophthalmic procedures incl. tonometry. P 1 or more drops as required. MINIMS CYCLOPENTOLATE Q At discretion of physician. Chauvin B Cornea may be damaged by prolonged use. Protect eye from dust and contamination. 2MO Hyperaemia. Anticholinergic. Cyclopentolate (HCl) 1%, preservative free; single dose eye drops. 20, A5.93. MINIMS PHENYLEPHRINE Chauvin S Mydriatic and cycloplegic for ophthalmic 2MO examination and treatment. Sympathomimetic. Phenylephrine (HCl) 2.5%, 10%, V 1 or more drops as required; see lit. preservative free. single dose drops. 20, A6.93. D Narrow angle glaucoma or shallow S Mydriatic for diagnostic or therapeutic anterior chamber. Neonates. procedures. B Use with caution in inflamed eye. P 1 drop of either strength as required. A Local irritation, hyperaemia, oedema, Q 1 drop of 2.5% soln. as required. conjunctivitis. Systemic effects (rare). D Narrow angle glaucoma, hypertension, MINIMS FLUORESCEIN Chauvin coronary disease, contact lenses, long term insulin dependant diabetes, hyperthyroidism. 2NO B Hyperaemia. Stain. Fluorescein Na+ 1%, 2%, preservative free; C b blockers, MAOIs, tricyclic antidepressants, adrenergic-blockers, PRESCRIBING NOTES phenothiazines. MYDRIATICS, ANAESTHETICS AND STAINS A Irritation, punctate keratitis, corneal LOCAL ANAESTHETICS: The two main local oedema, pigment floaters. Hyperaemia. A Local irritation, hyperaemia, oedema, conjunctivitis
anaesthetics employed are oxybuprocaine and amethocaine, which act within a few seconds and their effect wears off after a few hours. They produce adequate anaesthesia for removal of foreign objects and applanation tonometry. A compound preparation of lignocaine and fluorescein is can also be used for tonometry. MYDRIATICS act on the eye by dilating the pupil and paralysing the ciliary muscle. They are either antimuscarinic (atropine, cyclopentolate, homatropine, tropicamide) or sympathomimetic (phenylephrine) in action. They differ in their potency and duration of action. Tropicamide is short acting, lasting only a few hours, and causes little cycloplegia. Atropine can work for up to a couple of weeks and produces a profound cycloplegia; it can also be used in conjunction with phenylephrine when maximum cycloplegia is required. Mydriasis can cause acute angle closure glaucoma, usually in patients over 60 who are long sighted and have a shallow anterior chamber making them susceptible to this effect. Patients should be warned not to drive until the effects of the drugs have worn off. DIAGNOSTICS: Fluorescein sodium and rose bengal are used to detect corneal damage due to injury or disease. They are both water soluble dyes and are taken up by hydrophilic substances, such as corneal stroma, tears, and damaged epithelial cells. NSAIDs: Diclofenac sodium is used to inhibit intraoperative miosis during cataract surgery, and subsequent inflammation following this type of surgery. It does not exhibit intrinsic mydriatic properties, but acts through inhibition of prostaglandin E2 synthesis, and can also be used to treat pain following eye trauma or surgery. References available on request.
DRUGS
14.1
recovery of accommodation) for refraction. V 1 or 2 drops of either strength at 1-5 min. intervals. If patient not examined within 30 min. an additional drop should be used. D Narrow angle glaucoma. Soft lenses. B Unknown IOP. In infants put pressure over lachrymal sac for 1 min. A Transient stinging, dry mouth, blurred vision, photohobia, tachycardia, headache. Psychotic reactions, behavioural changes.
MYDRILATE
Intrapharm Labs.
2MO Anticholinergic. Cyclopentolate (HCl) 0.5% and 1%; drops. 0.5%-5ml, A1.45; 1%-5ml, A1.67. S Cycloplegic and mydriatic for refraction. P Refraction-1 drop of 0.5% soln. repeated 15-20 min. later if necessary. Q Refraction-under 6 years, 1 or 2 drops of 1% soln; over 6 years, 1 drop of 1% soln. V Mydriasis-1 drop 0.5% or 1% as required. D Paralytic ileus. B Raised IOP. Prostatic enlargement, coronary insufficiency. A Systemic anticholinergic effects.
14.1 ANTI-ALLERGIC DRUGS
CETRINE
Rowex
2MO Non-sedative antihistamine. Cetirizine (diHCl) 10mg. White oblong film-ctd tab. scored on one side. 10mg-30, A6.08.
2K
ALSO CETRINE ALLERGY Cetirizine (diHCl) 10mg. White oblong film-ctd tab. scored on one side. 7, A3.10; 28, A6.65. S Seasonal and perennial allergic rhinitis, MINIMS ROSE BENGAL Chauvin urticaria, senile pruritus. Q Under 6 years, not recommended. 2 V 1 daily. Moderate renal impairment: Stain. Rose Bengal 1%w/v, preservative free; single 5mg once daily. Severe renal impairment: 5mg dose, sterile eye drops. 20, A8.15. once every 2 days. S As a diagnostic stain. Location of D Lactation. End-stage renal disease degenerated cells in dry eye syndrome, particularly (ccQ10ml/min). Sjo¨rgren’s syndrome. B Significant renal impairment or V 1 or 2 drops as required. decreased hepatic function. Pregnancy. Contains D Dry eyes. Pregnancy, lactation (only if lactose. essential). C Caution: CNS depressants (insufficient B Contact lenses, driving or operating data). hazardous machinery. A Minor CNS disturbances, eg. A May discolour the eyelids/conjunctiva. somnolence, fatigue, dizziness, headache.
MINIMS TROPICAMIDE
Chauvin
2N Anticholinergic. Tropicamide 0.5%, preservative free. 20, A8.15. S Short acting mydriatic and cycloplegic. P 2 drops at 5 mins. intervals then 1-2 drops 30 mins. later if required. Q At discretion of physician. D Narrow angle glaucoma or shallow anterior chamber. B In infants put pressure over lachrymal sac for 1 min. A Transient stinging, dry mouth, blurred vision.
DEPO-MEDRONE
Pharmacia
0NO
Glucocorticoid: (Prohibited in Competition when given by intra-muscular route. See monograph in Section 6.2 for peri- and intra-articular administration) Methylprednisolone acetate 40mg/ ml. Susp. for inj. in vials. 1 x 1ml, A2.97; 1 x 2ml, A5.33; 1 x 3ml, A7.73. S Severe seasonal and perennial allergic rhinitis. P 80-120mg (2-3ml) IM See SPC. Q Dose depends on condition and to a lesser extent body weight and patient age. D See SPC. Do not give via intrathecal or IV routes. MYDRIACYL Alcon B Elderly, children, diabetes, chronic 2NO psychoses, CHF, renal insufficiency, glaucoma, Anticholinergic. Tropicamide 0.5%, 1%; drops. osteoporosis. See SPC. 0.5%-5ml, A1.59; 1%-5ml, A1.96. C Cyclosporin, warfarin, salicylates. A Hypersensitivity, GI disorders, elevated S Mydriatic and cycloplegic (with rapid
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
279
14.1 ANTI-ALLERGIC
ALLERGY
DRUGS A Fatigue, headache, increased appetite, GI disorders such as nausea, gastritis, dyspepsia, dry mouth and nose bleeding, pharyngitis.
children. Intra-articular inj.: Avoid over-use of joints in which symptomatic benefit has been obtained; avoid inj. into the tendon itself if inj. are given into tendon sheaths; avoid repeated inj. HISTEK Helsinn Birex into inflamed tendons. Do not inj. into achilles tendon. IM inj.: During prolonged therapy a 2MO Antihistamine. Cetirizine (diHCl)10mg. White oval liberal protein intake is essential. Pregnancy (only if essential), lactation. See SPC. scored tab. 7 (OTC), A2.21; 30, A3.50. GRAZAX ALK S Treatment of perennial rhinitis, seasonal C Amphotericin B inj. and K+ depleting agents, anticholinesterases, oral anticoagulants, 2M allergic rhinitis (hay fever), chronic idiopathic antidiabetics, antihypertensives incl. diuretics, antiurticaria. Allergen extract. Standardised allergen extract of tubercular drugs, cyclosporin, digitalis glycosides, P 1 daily. Renal or hepatic impairment, grass pollen from Timothy (Phleum pratense) oestrogens, hepatic enzyme inducers, human 5mg daily. 75,000 SQ-T. White circular oral lyophilisate growth hormone, ketonconazole, nondepolarising Q Under 12 years, not allowed; over 12 debossed with an image on one side. 30, A75.00 muscle relaxants, NSAIDs, thyroid drugs, vaccines. years, same as adult. (GMS-restricted prescriber list). A Fluid and electrolyte disturbances. D Lactation. S Grass pollen induced rhinitis and Hypersensitivity reactions. GI, musculoskeletal, skin, B Moderate to severe renal impairment, conjunctivitis in adults with clinically relevant eye, endocrine and neurological disorders. See symptoms and diagnosed with a positive skin prick hepatic impairment. Pregnancy. SPC. C Alcohol and CNS depressants (avoid). test and/or specific IgE test to grass pollen. st Theophylline. P 1 daily. 1 dose under medical LORAT Rowex supervision. Begin 4 months before pollen season A Headache, dizziness, drowsiness, (efficacy may also occur if start 2-3 months before agitation, rash, nausea, palpitations, dry mouth, GI 2 M O discomfort. season). Continue daily for 3 years (progressive Antihistamine. Loratadine 10mg. White oval immunomodulatory effect). Do not continue if no tablets scored and marked LT 10. 7, A2.95; 30, st KENALOG BMS A8.07. relevant improvement occurs in 1 year. W No data. 0NO S Symptomatic treatment of allergic D Malignancy or systemic diseases rhinitis and chronic idiopathic urticaria. Glucocorticoid (Prohibited in Competition when affecting immune system. Inflammatory conditions given by intra-muscular route. See monograph in P 1 once daily. Severe liver impairment: in oral cavity with severe symptoms. Uncontrolled/ Section 6.2 for intra-articular administration). Admin. every other day. severe asthma. Q Under 2 years, not recommended. 2-12 Triamcinolone acetonide 40mg/ml. 1ml, 2ml preB Oral surgery. If local adverse reactions years: R30kg, 10mg not appropriate; q30kg or filled syringes for IM use only. 1ml, A2.46; 2ml, occur consider anti-allergic medication. A4.26. over 12 years, as per adults. Discontinue and consult physician if: Severe B Caution: Severe hepatic impairment, S Allergic states, adrenocortical systemic reactions occur; deterioration in asthma insufficiency, collagen disorders, severe dermatitis. prostatic hypertrophy, urinary retention, signs/symptoms. Severe allergic reactions may be glaucoma. Discontinue at least 48 hrs before skin P Initially 40mg injected deeply into treated with adrenaline. Simultaneous vaccination. gluteal muscle, then according to response. Hay test. Contains lactose. Pregnancy, lactation (not Contains fish derived gelatine. Pregnancy. recommended). fever or pollen asthma, 40-100mg as single inj. C Use with symptomatic anti-allergics may Q Under 6 years, not recommended; 6-12 A Fatigue, headache, nervousness increase patients tolerance. (children). Somnolence, headache, increased years, adjust adult dose according to age, weight A Headache, oral paraesthesia, eye/ear/ appetite (adults). and severity. skin pruritus, conjunctivitis, throat irritation, D Systemic infections unless specific antisneezing, cough, asthma, pharyngitis, rhinorrhoea, infective therapy is employed. Admin. by IV, NALCROM Italchimici nasal congestion/passage irritation, rhinitis, throat intrathecal or intraocular inj. 2MO tightness, GI disorders, fatigue. B Risk of increased susceptibility to Mast cell stabiliser. Cromoglycate (Na+) 100mg. infections and their severity. Recent intestinal Clear hard cap. containing white powder and HISTACLAR Gerard anastomoses, thrombophlebitis, psychotic marked Sodium Cromoglicate 100mg. 100, A15.92. 2MO tendencies, exanthematous disease, chronic S Food allergy. Antihistamine. Loratadine 10mg. White film-ctd nephritis, metastatic carcinoma, osteoporosis, P 2, four times daily before meals. tab. scored one side, marked LR10 on reverse. 7, active peptic ulcer (or history); latent or healed Q Under 2 years, not recommended; over A3.32 (OTC, non-GMS); 30, A8.49. tuberculosis; in acute glomerulonephritis. 2 years, half adult dose. S Relief of symptoms associated with Hypertension; glaucoma (or history), previous A Nausea, rash, joint pain. allergic rhinitis (perennial and seasonal), idiopathic steroid myopathy or epilepsy, diabetes, chronic urticaria. hypothyroidism, cirrhosis. Do not carry out intraNEOCLARITYN Schering-Plough P 1 once daily before food. articular inj. in the presence of active infection in Q Under 12 years, not recommended; over or near joints. Intra-turbinal, subconjunctival, sub- 2 N O H1-antagonist. Desloratadine 5mg. Pale blue tab. 12 years, same as adults. tenons, retrobulbar and intraocular inj.; no marked with logo. 30, A10.35. B Severe hepatic disorders. Discontinue 4 adequate safety data. Anaphylactoid reactions P 1 daily. days prior to skin test. Dry mouth with risk of reported rarely. Withdraw gradually. Contains Q Under 12 years, not recommended; over caries during long-term treatment. benzyl alcohol. Prolonged use; particularly in 12 years, same as adult. liver function tests, anti-inflammatory and immunosuppressive effects, musculoskeletal effects, fluid and electrolyte disturbances, skin disorders, endocrine and metabolic disorders, neuropsychiatric disorders, ophthalmic disorders, leucocytosis, thromboembolism, malaise, withdrawal symptoms.
PRESCRIBING NOTES ANTI-ALLERGIC DRUGS ANTIHISTAMINES act by blocking histamine receptors. They are best used prophylatically before an allergic reaction has occurred to a stimulus. They are of no use in the treatment of asthma. They can be used to relieve pruritus, allergic rhinitis, stings, urticaria and other mild allergic conditions. Antihistamines differ in their duration of action and the extent of sedative and antimuscarininc side effects. Older antihistamines (trimeprazine, promethazine) cause sedation, to such an extent they are used in children as sedatives while chlorpheniramine cyclizine and mequitazine are less sedating. Sometimes this sedation may be beneficial when treating pruritus due to allergies. Sedation will be enhanced if patients also consume alcohol during treatment. Non-sedating antihistamines such as acrivastine, cetirizine, levocetirizine, fexofenadine, loratadine and mizolastine are less sedating as they poorly penetrate the blood brain barrier. Other side effects include antimuscarininc effects including urinary retention, dry mouth, blurred vision and GI disturbances. NON-STEROIDAL ANTI-INFLAMMATORIES inhibit degranulation of mast cells and the subsequent release of histamine. Sodium cromoglycate is particularly useful in food allergy as it is poorly absorbed from the GI tract. ANTI-ALLERGIC ketotifen, has mast cell stabilising and antihistamine activity. References available on request.
280
2NO ALSO NEOCLARITYN ORAL SOLUTION Desloratadine 0.5mg/ml. 100ml, A5.98. 150ml, A9.25. S Allergic rhinitis. Urticaria. P 10ml once daily. Q Under 1 year, not recommended; 1-5 years, 2.5ml once daily; 6-11 years, 5ml once daily. Over 12 years, same as adult. B Severe renal insufficiency. Pregnancy, lactation; not recommended.Oral solution contains sucralose and sorbitol. A Fatigue, dry mouth, headache, diarrhoea, fever, insomnia.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALLERGY PERIACTIN
ANTI-ALLERGIC MSD
2
DRUGS
14.1
(tartrate) 7.5mg/5ml. 100ml, A3.38.
S Seasonal allergic rhinitis. P 1 daily. Q Not recommended.
2M
ALSO VALLERGAN FORTE SYRUP Trimeprazine (tartrate) 30mg/5ml. 100ml, A6.48. S Pruritus, urticaria. Short term sedation and pre-anaesthetic medication in children. P 30-40mg daily in divided doses. Q Urticaria/pruritus: 7.5-20mg (5-13ml) daily in divided doses. Sedation: 7-12 years, 6090mg daily in divided doses. 3-6 years: 15-60mg daily in divided doses. Pre-anaesthetic medication (2-7 years): Max. 2mg/kg. TIRITEK ALLERGY Gerard D Coma. Lactation. B History of jaundice, liver dysfunction, 2K blood dsycrasias. Coronary insufficiency, cardiac Antihistamine. Cetirizine (diHCl) 10mg. White, circular, biconvex film-ctd tab, embossed A on one disease. Extremes of temperature. Jaundice (discontinue if occurs). Pregnancy (only if side and scored on the other. 10mg-7, A2.30. S Seasonal and perennial allergic rhinitis, essential). Long-term use. C Drugs potentially haemotoxic (contra), chronic idiopathic urticaria. P 10mg daily. Moderate renal impairment: alcohol, CNS depressants, antihypertensives, anticholinergics, MAOIs, antidepressants, 5mg once daily. Q 6-12 years: 1/2 tab. twice daily or 1 tab. analgesics, desferrixoamine. A Nasal stuffiness, dry mouth, insomnia, daily. Over 12 years, as per adults. agitation, drowsiness, skin rashes, respiratory PHENERGAN sanofi-aventis D Severe renal impairment. Avoid depression. Extrapyramidal reactions, lactation. 2O photosensitivity, convulsions (high doses). B Significant renal impairment or Antihistamine (phenothiazine type). Promethazine decreased hepatic function. Contains lactose. XYZAL UCB (HCl) 25mg. Blue sug-ctd tab. marked PHENERGAN Pregnancy. 25. 56, A1.77. 2MO C Caution: CNS depressants. S Allergic conditions. A Mouth dryness, somnolence. H1-antagonist. Levocetirizine diHCL 5mg. White P Initially 1 at night increasing to 2-3 at oval film-ctd tab. marked with a Y logo. 30, night if necessary. UCERAX UCB A10.04. Q Use elixir. 2MO Antihistamine/5-HT antagonist. Cyproheptadine (HCl) 4mg. White scored tab. marked MSD 62. 30, A1.21. S Allergic disorders and pruritic dermatoses. P 4mg-20mg daily. Q Under 2 years, not recommended; 2-6 years, 2mg; 7-14years, 4mg. Both three times daily. D Glaucoma, prostatic hypertrophy, bladder neck obstruction, urinary retention, pyloroduodenal obstruction, stenosing peptic ulcer, elderly debilitated patients, lactation, neonates, acute asthma attack. B Bronchial asthma, pregnancy, raised intraocular pressure, hyperthyroidism, CVD, hypertension, young childrenq2 years. C Alcohol, CNS depressants, MAOIs. A Drowsiness, impaired reactions. Anticholinergic effects, paradoxical excitation in children.
2
ALSO PHENERGAN ELIXIR Promethazine (HCl) 5mg/5ml. 100ml, A4.41. P 10-20mg two or three times daily. Q Under 2 years, not recommended; 2-5 years, 5-15mg; over 5 years, 10-25mg. If 2 doses in 24 hours are required use lower amount stated.
2MO
ALSO TELFAST 180 Fexofenadine (HCl) 180mg peach cap.-shaped film-ctd tab. 30, A12.16. S Chronic idiopathic urticaria. P 1 daily. Q Not recommended. B Pregnancy, lactation. A Headache, nausea, dizziness, fatigue.
2NO
Nonbenzodiazepine anxiolytic. Hydroxyzine HCI 25mg. White, oblong, film-ctd biconvex scored tabs. 25, A1.31.
2NO
ALSO UCERAX SYRUP Hydroxyzine HCI 10mg/5ml. Clear to slightly yellow syrup (2 flavours). 200ml, A2.75. 2NO S Anxiety/tension states, psychomotor ALSO PHENERGAN INJECTION Promethazine (HCl) agitation and acute stress situations e.g. minor 25mg/ml; amp. 10 x 1ml, A3.25. surgical procedures or allergic states. Pruritus due P 25-50mg by deep i.m. inj. or slow i.v. to allergic conditions e.g. chronic urticaria, atopic/ inj. after dilution. contact dermatitis, histamine-mediated pruritus. Q Under 5 years, not recommended; over P Anxiety: 50mg daily in 3 doses of 5 years, 6.25-12.5mg by deep i.m. inj. 12.5mg-12.5mg-25mg. More severe cases, up to B Alcohol, CNS depressants, MAOIs. 300mg daily. Pruritus: Initially 25mg before C Alcohol, CNS depressants, MAOIs. resting, then if necessary up to 25mg, 3-4 times A Drowsiness, impaired reactions. daily. Max.: Single dose, 200mg; daily dose, Dizziness, disorientation, photosensitivity. 300mg. Hepatic dysfunction, reduce daily dose by Extrapyramidal reactions, convulsions (high doses). 33%. R Initially, half recommended dose. PIRITON GSK Q Over 6 years: 1mg/kg up to 2mg/kg 2 daily in divided doses. Antihistamine (arylalkylamine type) D Pregnancy and lactation. Porphyria. Chlorpheniramine maleate 4mg. Cream tab. B Caution: Glaucoma, bladder outflow marked Piriton AH. 30, A2.25. obstruction, decreased GI motility, myasthenia S Allergic conditions. gravis, dementia. Increased potential for P 1 tab. 3 or 4 times daily. convulsions; known predisposing factor to cardiac Q Under 6 years, not recommended; 6-12 arrhythmia or concomitant treatment with years, v-1 tab. 3 or 4 times daily. potentially arrhythmogenic drugs. Young children, D Pre-coma states. elderly, moderate/severe renal impairment (reduce B Lactation (sust.-release prep.). dose). Stop at least 5 days before allergy testing. Pregnancy. Contains ethanol, sucrose. Driving or using C Alcohol, CNS depressants, MAOIs. machines. A Drowsiness, impaired reactions. C Avoid: MAOIs, alcohol. Barbiturates, Dizziness. other CNS depressants, anticholinergics, betahistine, anticholinesterases, phenytoin, TELFAST sanofi-aventis cimetidine, CYP2D6 substrates.
2MO Antihistamine (piperidine type). Fexofenadine (HCl) 120mg peach cap.-shaped film-ctd tab. 30, A9.35.
VALLERGAN
sanofi-aventis
2M Antihistamine (phenothiazine type). Trimeprazine
ALSO XYZAL ORAL DROPS Levocetirizine diHCL 5mg/ml. Oral drops. 20ml, A17.82. S Allergic rhinitis and chronic idiopathic urticaria.
2MO ALSO XYZAL SOLUTION Levocetirizine diHCL 0.5mg/ml. Oral solution. 200ml, A9.04. P 5mg daily (1 tab or 10ml soln or 20 drops). Renal impairment: Moderate (cc: 30-49ml/ min), 5mg once every 2 days; severe (ccQ30ml/ min), 5mg once every 3 days. Duration: Hay fever, 3-6 weeks; short-term pollen exposure, 1 week. Q 2-6 years: 2.5mg daily (oral drops/soln only), taken in 2 divided doses (2.5ml soln twice daily or 5 drops twice daily). 6-12 years: 5mg daily (1 tab or 10ml soln or 20 drops). Under 2 years, not recommended. Renal impairment: Adjust according to body weight. D Severe renal impairment (ccQ10 ml/ min). B Pregnancy, lactation. Tab. contain lactose. Oral drops/soln contain methyl/propyl parahydroxybenzoate. Soln contains maltitol. C Caution: Alcohol, other CNS depressants. A Headache, somnolence, dry mouth, fatigue.
ZADITEN
Novartis
2MO Antihistamine/mast cell stabiliser. Ketotifen (hydrogen fumarate) 1mg. White scored tab marked ZADITEN 1. 60, A9.92.
2MO ALSO ZADITEN CAPS Ketotifen (hydrogen fumarate) 1mg. White cap. marked CS. 56, A10.89.
2MO ALSO ZADITEN ORAL SOLN. Ketotifen (hydrogen fumarate) 1mg/5ml. 300ml, A10.88. S Allergic rhinitis and conjunctivitis. P 1-2mg twice daily with food.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
281
15.1 EMOLLIENTS
DERMATOLOGY
crunching or chewing. Duration not to exceed period of symptoms; 2-3 weeks max. After disappearance of nasal symptoms, continue with antihistamine alone. Moderate renal / hepatic insufficiency: 1 tab. daily. Q Over 12 years, as per adults. Under 12 years, not recommended. D hypertension, ischaemic heart disease; severe renal insufficiency, incontrolled hyperthyroidism, severe arrhythmias, pheochromocytoma, elevated intraocular pressure, urinary retention. Pregnancy, lactation. ZIRPINE Pinewood B Caution: Patients q 50 years, diabetes, hyperthyroidism, tachycardia, arrhythmia, angina, 2MO moderate hepatic/renal insufficiency, prostatic H1 antagonist. Cetirizine (diHCl) 10mg. White round film-ctd tab. marked AG one side, scored on hypertrophy, urethral dysfunction, history/high risk of stroke, hypercoagulability risk (inflammatory reverse. 30, A6.05; 7 (OTC, non-GMS), A3.10. bowel disease). May act as cerebral stimulant. S Perennial and seasonal allergic rhinitis, Contains lactose. Driving/operating machinery. urticaria. C Not recommended: MAOIs (within 2 P 1 daily. Hepatic/severe renal weeks), b-blockers, sympathomimetics, impairment, reduce dose to 5mg daily. dihydroergotamine, amphetamines; vasocontrictors Q Under 12 years, not recommended. and other decongestants (in case of stroke or D Lactation. factors which could increase haemorrhagic stroke B Impaired hepatic and renal function. risk). Not advised in digitalised patients. Caution: Pregnancy (avoid). Contains lactose. Sedatives, halogenated anaesthetic agents, alcohol C Caution: Alcohol, CNS depressants. ingestion, CNS depressants, NSAIDs. Antacids and A Minor CNS disturbances incl. PPIs increase pseudoephedrine absorption, kaolin somnolence, fatigue, dizziness and headache. If reduces absorption. Can interfere with cutaneous affected take dose half morning and evening. tests for allergies (appropriate wash out period ZIRTEK UCB required). A Tachycardia, dry mouth, nausea, 2MO weakness, vertigo, dizziness, headaches, Non-sedative antihistamine. Cetirizine (diHCl) drowsiness, nervousness, insomnia. 10mg. White oblong film-ctd scored tab. marked Y/Y. 7, A3.59; 30, A3.66 . ZIRTENE Gerard S Seasonal and perennial allergic rhinitis, 2MO urticaria, senile pruritus. Antihistamine. Cetirizine (diHCl) 10mg. White, Q Under 6 years, not recommended. capsule shaped, film-ctd tab, scored and marked V 1 daily. Moderate renal impairment: CZ and 10 on one side and marked G on reverse. 5mg once daily. Severe renal impairment: 5mg 10mg-30, A7.16. once every 2 days. S Seasonal and perennial allergic rhinitis, 2K ALSO ZIRTEK SOLUTION Cetirizine (diHCl) 1mg/ml. urticaria, senile pruritus. P 1 daily. Moderate renal impairment: Banana-flavoured, sugar-free sln. 100ml, A7.20. P 5ml (spoonful) twice daily or 10ml once 5mg once daily. Severe renal impairment: 5mg once every 2 days. daily. Q Over 12 years, as per adults. Q Under 2 years, not recommended. 2-6 D End-stage renal disease (ccQ10ml/min). years, dose based on body weight. 10kg, 1.5ml Avoid pregnancy, lactation. twice daily; 15kg, 2.5ml twice daily; 20kg, 3ml B Significant renal impairment or twice daily; 25kg, 4ml twice daily; 30kg, 4.5ml decreased hepatic function. Contains lactose. twice daily. 6-12 years, 5ml twice daily. C Caution: CNS depressants (insufficient D Lactation. End-stage renal disease data). (Q10ml/min cc). A Minor CNS disturbances, eg. B Significant renal impairment or decreased hepatic function. Pregnancy (insufficient somnolence, fatigue, dizziness, headache. data). ZYNOR Teva C Caution: CNS depressants (insufficient data). 2MO A Minor CNS disturbances, incl. Antihistamine. Cetirizine (diHCl) 10mg. White filmsomnolence, fatigue, dizziness and headache. ctd tab. marked CTZ 10 one side scored on reverse. 30, A7.51.
Q Under 2 years, not recommended; over 2 years, 1mg twice daily with food. D Pregnancy, lactation. B Withdraw over 2-4 weeks. Intercurrent infections should be treated with specific antimicrobial therapy. Reactions may be impaired. C Alcohol, CNS depressants, oral hypoglycaemics, antihistamines. A Drowsiness, impaired reactions, dry mouth, dizziness. Occasionally CNS stimulation, weight gain.
ZIRTEK PLUS DECONGESTANT
UCB ALSO ZYNOR ALLERGY Cetirizine (diHCl) 10mg.
0K
Antihistamine/sympathomimetic. Cetirizine HCl (immediate release)/ pseudoephedrine HCl (prolonged release), 5mg/120mg. White to off white prolonged release tab. 10, A7.31. S Symptoms (e.g. nasal congestion, sneezing, rhinorrhoea, nasal and ocular pruritus) associated with seasonal or perennial allergic rhinitis in adults and children over 12 years. P 1 tab. twice daily (morning and evening). Swallowed whole with liquid, without
282
2K
White film-ctd tab. marked CTZ 10 one side scored on reverse. 7, A2.65. S Management of seasonal and perennial allergic rhinitus, urticaria, senile pruritus. P 10mg daily in the evening. Dosage may be halved and taken twice daily for patients who experience mild side effects. Renal impairment, 5mg daily. Q Under 12 years, not recommended; over 12 years, same as adults D Pregnancy. Lactation.
B Renal impairment, decreased hepatic function. May in some sensitive people cause drowsiness, if so do not drive or operate machinery. C CNS depressants. A Headache, dizziness, dry mouth and sedation, reversible changes in liver function.
15.1 EMOLLIENTS
ANTHISAN
sanofi-aventis
2K Antihistamine, analgesic, antipruritic. Mepyramine (maleate) 2% w/w. Cream. 15g, A3.65. S Allergic skin disorders, insect bites and stings. P Apply two or three times daily for up to 3 days. D Eczema. Pregnancy, lactation (unless essential). B Broken skin. A Skin sensitisation, eczematous reactions and photosensitivity.
AQUADRATE
Alliance
2 Emollient. Urea 10%. Cream. 100g, A6.68. S Ichthyosis, hyperkeratosis and other chronic dry skin conditions. V Apply sparingly to cleansed and dried skin, rubbing in well as required. B Avoid moist or broken skin. Pregnancy (only if benefit outweighs risk).
CALDEASE
Roche Consumer
2K Emollient. Zinc oxide 15%, cod liver oil 15%. Oint. 30g, A2.81. S Nappy rash, minor skin irritations, superficial wound and burns. Q Nappy rash: Apply at each nappy change. D Fungal infections, large surface wounds and major burns.
CALMURID
Galderma
2 Hydrating/keratolytic agents. Urea 10%, lactic acid 5%; cream. 100g, A7.99; Pump dispenser-500g, A34.95. S Ichthyosis and other hyperkeratotic dry skin conditions. V Apply a thick layer twice daily after cleansing and drying. Leave on skin for 3-5 min., then rub in and remove excess.
DERMAMIST DRY SKIN SPRAY Alliance
2K Emollient. White soft Paraffin 10.0% w/w. Cutaneous colourless spray delivered by pressurised aerosol. 1, A4.05. S Dry skin conditions (pruritus of the elderly, eczema, ichthyosis). V Shake before use. Bathe or shower not more than 10 min. Spray sparingly from a distance of 20cm. B Do not use on broken skin (cuts or lesions). Do not spray directly on face. Avoid inhalation.
DIPROBASE
Schering-Plough
2
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY
EMOLLIENTS 15.1
Emollient. Liquid paraffin 6%, white soft paraffin 15%, cetomacrogol 2.25%, cetostearyl alcohol 7.2%. Cream. 50g, A2.46; 500g with dispenser, A10.69.
2 ALSO DIPROBASE OINTMENT Liquid paraffin 5%, white soft paraffin 95%. 50g, A2.46. S Alternate or maintenance therapy with topical steroids. Diluent for topical steroids. V Apply sparingly as required.
E45 CREAM
colourless water-dispersible bath oil. 350ml, A5.50. S Dry skin conditions such as eczema, ichthyosis and senile pruritus. V 1-3 capfuls to bath water, soak for 1015 min. Infants: v to 2 capfuls to a small bath of water. B Avoid eyes. Take care to avoid slipping in shower/bath. If aggravation occurs consult doctor.
KAMILLOSAN
Reckitt Benckiser 2
2 ALSO OILATUM EMOLLIENT SHOWER GEL Liquid paraffin 70%. Gel. 150g, A4.57. V Apply to wet skin, massage in, then rinse and dry.
Goldshield 2
ALSO OILATUM JUNIOR FLARE-UP Light liquid paraffin 52.5%, benzalkonium Cl 6%, triclosan 2%. Colour- and fragrance-free bath oil. 150ml, A4.19. S Infected eczemas and eczemas at risk of infection. Q Over 6 months, 1 capful to 10cm bath. Actavis Soak for 15 mins. and pat skin dry. Use once daily.
Emollient. Chamomile ext. 10.5%. Oint. 50g, A5.50. S Sore nipples, chapped skin, nappy rash. P Apply twice daily or after breastfeeding. Q Apply with nappy change.
2
Emollient. White soft paraffin 14.5%, light liquid paraffin 12.6%, hypoallergenic anhydrous lanolin 1% in especially formulated emulsion base. 50g, A2.47; 125g, A4.40; 500g, A8.26. S Dry skin conditions, incl. eczema flaking, MORHULIN itching, chapped skin, nappy soreness, sunburn and detergent hands. Apply two or three times 2K daily. Emollient. Cod liver oil 11.4% w/w, zinc oxide 38% 2 w/w. Oint. 50g, A2.65. ALSO ITCH RELIEF CREAM FROM E45 S Management of superficial trauma Lauromacrogols 3%, urea 5%. Cream. 50g, A3.47. V Apply to the affected area as required. S Pruritus, eczema, dermatitis and scaling B Contains wool fat - may cause contact skin conditions requiring hydrating effect. dermatitis. V Apply twice daily to affected area. A Rarely, rash. D Acute erythroderma, acute OILATUM EMOLLIENT Stiefel inflammatory, oozing or infected skin lesions. Broken or inflamed skin. 2 Acetylated wool alcohols 5%, liquid EMULSIDERM EMOLLIENT Dermal Emollient. paraffin 63.4%. Liquid. 150ml, A3.45; 250ml, 2 A4.55; 500ml, A7.12. Emollient antiseptic. Liquid paraffin 25%, S Contact dermatitis, atopic dermatitis, isopropyl myristate 25%, benzalkonium Cl 0.5%; senile pruritus, ichthyosis and related dry skin emulsion. 300ml, A7.99; 1l, A18.89. conditions. S As an adjunct in the management of P Add 1-3 capfuls to bath and soak for dry skin, by rehydration with antisepsis. 10-20 mins. or apply small amount directly to wet V Add 7-30ml to bath of warm water and skin, rub in, then rinse and dry. soak for 5-10 mins., or rub small amount into skin. Q Infants, add v -2 capfuls to wash-basin and apply over entire body; others, same as adult.
EUCERIN INTENSIVE 10% 2
Beiersdorf 2
Hydrating/keratolytic agent. Urea 10%. Cutaneous emulsion. 250ml, A8.52. S Ichthyosis, xeroderma (especially in the elderly), hyperkeratosis and other chronic dry skin conditions such as atopic eczema (dermatitis). V Apply twice daily. D Excoriated acute inflammation of the skin, renal insufficiency. B Consult doctor if symptoms persist. C Increases penetration of certain topical preparations e.g. corticosteroids, dithranol and fluorouracil.
EURAX
P Add 1-3 capfuls to bath; soak for 10-20 mins. pat dry. Q Infants, add v-2 capfuls to basin of water; apply over entire body and pat dry; others, same as adult.
Novartis Consumer
2 Antipruritic. Crotamiton 10% lotion and cream. Lotion-100ml, A3.83; Cream-30g, A3.09; 100g, A5.34. S Pruritus. V Massage in as required. D Acute exudative dermatitis. B Avoid eyes, broken skin or weeping skin conditions.
HYDROMOL BATH AND SHOWER EMOLLIENT
Alliance
2K Emollient. Light liquid paraffin 37.80%, isopropyl myristate 13%, iso-octyl stearate 15.95%, laureth-3 11.25%, macrogol-7 glycerol cocoate 22%. Clear,
ALSO OILATUM CREAM Light liquid paraffin 6%, white soft paraffin 15%. Cream. 40g, A2.36. V Apply after washing and as required.
2 ALSO OILATUM JUNIOR Light liquid paraffin 63.4%. Liquid. 150ml, A3.45; 300ml, A6.48; 350ml pump pack, A5.48.
2 ALSO OILATUM PLUS Light liquid paraffin 52.5%, benzalkonium Cl 6%, triclosan 2%. Bath additive. 500ml, A10.01. S Infected eczemas and eczemas at risk of infection. P 2 capfuls in 20cm bath. Soak for 15 mins. pat dry. Q Infants, 1ml to basin water.
ORABASE
BMS
2 Skin protectant. Carmellose Na+, pectin and gelatin, equal parts in Plastibase. Oint. 30g, A1.89. S Protection for lesions of oral mucosa and moist body surfaces. V Cover the affected area with a thin film; do not rub in.
R.B.C.
Rybar
2 Antipruritic. Antazoline (HCl) 1.8%, calamine 8%, cetrimide 0.5% in emollient base. Cream. 25g, A1.41. S Sunburn, insect bites, allergic or pruritic skin conditions. V Apply every three hours or as required. Repeat once after 10 mins. to intensify relief.
SPRILON
Smith & Nephew
PRESCRIBING NOTES EMOLLIENTS AND OTHER SKIN PREPARATIONS EMOLLIENTS smooth the surface of the skin and increase its hydration. They are indicated for all types of dry and scaling skin disorders. For dry skin conditions, light emollients such as aqueous cream are suitable, but there are more greasy preparations available (liquid and white soft paraffin, emulsifying ointment). Emollients can be added to bath water, used in the shower and as a soap substitute. Urea is a hydrating agent and is used in compound preparations to aid absorption. BARRIER PREPARATIONS are water repellent in nature. Zinc ointments and dimethicone have both been used for protection of stoma areas, pressure sores and treatment of nappy rash. ANTIPRURITICS act by counter irritation. When known, the cause of the pruritus should be treated as it may be caused by systemic disease or a skin disorder. Emollients are of use if the cause is dry skin. Crotamiton relieves symptoms by producing erythema, while camphor produces a cooling effect through action on the cold receptors. Doxepin is indicated in the treatment of pruritus associated with eczema, however it can cause drowsiness and sensitisation. ANTIHISTAMINES act by blocking H2 receptors, reducing the effect of histamine release on surrounding tissues following injuries such as stings, bites and sunburn. They are best given orally, as topical application may cause sensitisation. Oral administration is also preferable when sedation may also be desirable. Insect stings can also respond well to a short course of treatment with a mild corticosteroid. References available on request.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
283
15.2 ANTI-INFECTIVE
DERMATOLOGY
TOPICAL SKIN PREPARATIONS
2
2NO
2
Barrier spray. Barrier Spray. Dimethicone 1.04%, zinc oxide 12.5%. Aerosol. 115g-1, A4.24. S Protection of skin from faeces and urine. Eczema, leg ulcers, spontaneous fissures, pressure sores. V Spray from 20cm for 2-3 secs.
Topical broad-spectrum antibiotic. Mupirocin 2%. Oint. 15g, A4.47. S Acute primary bacterial skin infections e.g. impetigo and folliculitis. V Apply to affected area up to three times daily. B Avoid eyes. Intranasal use. Pregnancy Ocean and lactation.
VASOGEN 2O
Emollient. Dimethicone 20%, zinc oxide 7.5%, calamine 1.5%. Cream. 50g, 71c; 100g, A1.20. S Barrier cream in dermatoses, pruritus, colostomies, ileostomies, nappy rash, eczema, bedsores. V Rub in gently, apply as required.
15.2 ANTI-INFECTIVE TOPICAL SKIN
CALDESENE 2
DRAPOLENE
Chefaro
2 Antiseptic. Benzalkonium Cl 0.01%, cetrimide
Clonmel 0.2%; cream. 100g, A3.16; 200g, A4.53.
Antifungal/antibacterial powder. Ca++ undecylenate 10% powder. 55g, A3.21. S Nappy rash, prickly heat and chafing.
S Napkin dermatitis, minor burns and wounds. V Apply twice daily or at each nappy change.
CANAZOLE
FLAMAZINE
Pinewood
2OY
PREPARATIONS
ALSO DESENEX OINTMENT Zinc undecenoate 20%, undecenoic acid 5%. Oint. 30g, A2.70. P Use as required. Q Under 2 years, not recommended. B Nail or scalp infections.
Smith & Nephew
2N
Imidazole antifungal. Clotrimazole 1%. Smooth white cream. 20g, A4.48 (20g not GMS
Antibacterial. Silver sulphadiazine 1%. Cream. (GMS) 50g, A5.18; 250g, A13.89; 500g, A24.60. S Burns, infected wounds, infected leg ulcers, pressure sores. S Fungal skin infections due to candida, 2K P Apply in layer 3-5mm thick. Change most commonly Candida albicans eg. vaginal Herpes-specific enzyme inhibitor. Aciclovir 5%. dressing 3 times weekly for ulcers; daily for burns. discharge and nappy rash. Dermatophytoses eg. White cream. 2g tube, A4.10. Q Up to 3 months, not recommended; ringworm and tinea pedis (athletes foot). S Treatment of cold sores. other, as for adult. Commensal yeast infections eg. Pityriasis versicolor V Apply 5 times daily at 4 hour intervals D Pregnancy. (tinea versicolor). for 5 days. Continue for further 5 days if healing P Apply thinly and evenly to affected area B Impaired renal or hepatic function. not complete. twice daily. Duration at least 1 month for B Not for use on mucous membranes FUCIDIN LEO Pharma dermatophyte infections and dermal Candidal (mouth, eye, vagina). Consider oral dosing in infections; 2 weeks for Tinea versicolor. 2NO severely immune-compromised patients. Pregnancy B Treat male partner to avoid recurrence Antibacterial. Fusidic acid 2%. Cream. 15g, A3.43; (only if benefit outweighs risk), lactation. of vaginal candidiasis. Cetostearyl alcohol (local 30g, A5.79. A Transient burning or stinging following skin reactions). Pregnancy (avoid, especially first 2NO application. Mild drying or flaking of the skin. trimester). ALSO FUCIDIN OINTMENT Sodium fusidate 2%. Erythema and itching. Rarely contact dermatitis. C Latex contraceptives; use alternative 15g, A2.81; 30g, A4.75. precautions for at least five days after. S Bacterial skin infections. BACTROBAN GSK Apply three or four times daily. Less CANESTEN CREAM Bayer HealthCare V frequent application if dressing used. PRESCRIBING NOTES 2OY B Avoid use in or near eye (oint). ANTI-INFECTIVE SKIN PREPARATIONS Imidazole antifungal. Clotrimazole 1%. Cream. Pregnancy (only if essential). ANTIBIOTICS: To minimise resistance it is 20g, A4.51 (trade price, non-GMS); 50g, A2.38. advisable only to use topical antibacterials, S Fungal and Gram-positive bacterial FUNGASIL Clonmel which are not also administered systemically. infections of the skin incl. candidal nappy rash. 2MO Some can cause sensitivity (neomycin) and some V Apply sparingly 2 or 3 times daily until Antifungal allylamine. Terbinafine (HCI) 10mg/g. can have systemic side-effects (ototoxicity with 2 weeks after apparent cure. Cream. 7.5 g, A2.06. aminogycoside). Mupirocin is not related to any A Local mild burning or irritation. S Fungal infections of the skin, caused by other antibacterial in use and is effective in DAKTARIN McNeil Healthcare Trichophyton, Microsporum canis and gram-positive skin infections. Silver Epidermophyton floccosum. Yeast infections of the 2O sulphadiazine is indicated in the treatment of skin, principally caused by the genus Candida. infected burns. Tetracyclines and Imidazole antifungal. Miconazole nitrate 2%, Pityriasis (tinea) versicolor caused by Pityrosporum A cream. 30g, 2.60. aminoglycosides are both broad spectrum and orbiculare. 2 O active topically for a range of infections. P Apply to affected skin and surrounding ALSO DAKTARIN POWDER Miconazole nitrate area. Tinea pedis/cruris/corporis: Once daily for 1 ANTIFUNGALS: Fungal infections can be 2%; dusting powder. 20g, A1.70. week. Cutaneous candidiasis: Once daily for 1-2 treated effectively with topical preparations weeks. Pityriasis versicolor: Once or twice daily for S Topical treatment of fungal infections unless there is a nail or scalp infection or the of the skin and secondary infections due to gram- 2 weeks. If no improvement after 2 weeks, verify affected area is large, in which case systemic positive bacteria (staphylococcus and streptococcus diagnosis. treatment may be indicated. Tinea infections can Q Under 12 years, not recommended. spp.). be treated with imidazoles (e.g. clotrimoxazole, D Pregnancy, lactation; not recommended. V Apply once or twice daily to affected econazole, miconazole, sulconazole) or other areas until lesions have completely healed. Powder B External use only. Avoid contact with antifungals including terbinafine, amorolfine and eyes. Contains cetyl alcohol and cetostearyl can be used seperately or with cream. the undecenoates. Benzoic acid preparations are alcohol. B If reaction suggesting irritation occurs, also effective but less acceptable to patients. A Application site reactions. treatment should be discontinued. Avoid contact Imidazole antifungals and nystatin can be used with eyes.
ACIC CREAM
Rowex reimbursable); 50g, A4.00.
to treat candidal infections. ANTIVIRALS: Acyclovir is indicated in the treatment of Herpes simplex infections. ANTIBACTERIALS and ANTISEPTICS: Use with care over prolonged periods to avoid sensitisation. References available on request.
284
GRANEODIN
DESENEX
BMS
Clonmel 2 N O
2 Antifungal. Zinc undecenoate 20% undecenoic acid 2%. Powder. 55g, A3.84. S Athleteâ&#x20AC;&#x2122;s foot. P Dust hosiery and shoes. Use as required. Q Under 2 years, not recommended.
Aminoglycoside. Neomycin sulph. 0.25%, gramicidin 0.025%; oint. 25g, A1.71. S Bacterial infections incl. impetigo and sycosis barbae. V Apply two to four times daily. D Fungal or viral infections; deep-seated
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY
ANTI-INFECTIVE TOPICAL
infections. B Avoid use of dressings. Large areas of damaged skin. A Ototoxicity, sensitisation.
A Application site reactions.
LOCERYL
Novartis Consumer
2MO Allyamine antifungal. Terbinafine (HCl) 1%. Cream. 15g, A5.30; 30g, A10.12. S Fungal infections of the skin caused by Trichophyton, Microsporum canis and Epidermophyton floccosum.Yeast infection of the skin (mainly Candida). Pityriasis (tinea) versicolor due to Pityrosporum orbiculare. P Massage into affected area once or twice daily for 1 (tinea pedis) to 2 (pityriasis versicolor) weeks. Q Not recommended.
2M ALSO LAMISIL AT CREAM Terbinafine (HCl) 1%. 7.5g, A4.62. S Tinea pedis (athlete’s foot) and tinea cruris (dhobie itch/jock itch) caused by Trichophyton and Epidermophyton floccosum. P Massage into affected area once or twice daily for 1 (tinea pedis) or 1-2 (tinea cruris) weeks. Q Under 16 years, not recommended.
2N ALSO LAMISIL ONCE Terbinafine (HCl) 1%. Sln. 4g-A8.79. S Tinea pedis (athlete’s foot). P Apply once on both feet (even if lesions only visible on one foot) and do not wash for 24h. Q Under 18 years, not recommended. D Lactation, pregnancy (unless benefits outweigh risks).
LANAFINE 1% CREAM
Niche
2MO Allylamine antifungal. Terbinafine (as HCl) 10mg per 1g. White cream. 15g, A3.31; 30g, A6.95. S Fungal infections of the skin caused by Trichophyton, Microsporum canis, Epidermophyton floccosum. Yeast infections of the skin, principally those caused by Candida. Pityriasis (tinea) versicolor due to Pityrosporum orbiculare.
2OY ALSO LANAFINE AFR 1% CREAM Terbinafine (as HCl) 10mg per 1g. White cream. 7.5g, A2.13. S Tinea pedis, tinea cruris caused by Trichophyton and Epidermophyton floccosum. P Apply once or twice daily to affected skin and surrounding area. Tinea pedis: 1 week. Tinea cruris, Cutaneous candidiasis, Pityriasis versicolor: 2 weeks. If no improvement after 2 weeks, verify diagnosis. Q Not recommended. D Pregnancy (unless benefit outweighs risk), lactation. B External use only.
15.2
POLYFAX
Teva
Galderma 2 N O
2MO
KETOZOL Rowex Antimycotic. Amorolfine (HCl) 5%. Nail lacquer soln. 5ml, A24.15. 2KO S Onychomycoses caused by Ketoconazole 2%. Clear reddish shampoo. 120ml, dermatophytes, yeasts and moulds. A6.59. P Apply to affected nail once weekly. S Seborrhoeic dermatitis of the scalp in Twice weekly applications may be beneficial in adults. some cases. P Wash affected areas with shampoo, Q Not recommended. rinse after 3-5 minutes. Repeat twice weekly for 2- D Hypersensitivity. Pregnancy, lactation 4 weeks. Prophylaxis, once every 1-2 weeks. (unless considered appropriate by physician). B Avoid eyes. B Avoid contact with eyes, ears and A Skin irritation, dry fragile hair, slight mucous membranes. hair loss. A Rarely pruritus, transient burning. LAMISIL
SKIN PREPARATIONS
Peptide antibiotics. Polymyxin B sulph. 10,000 units, bacitracin zinc 500 units per g; oint. 20g, A7.63. S Skin infections. V Apply sparingly two or more times daily. B Large open wounds. A Nephrotoxicity, rarely allergic reactions.
SAVLON ANTISEPTIC CREAM Novartis Consumer
2K
Antiseptic/disinfectant. Cetrimide 0.5%, chlorhexidine gluconate 0.1%; cream. 15g, A1.23; 30g, A1.64; 60g, A2.54; 100g, A3.69. MYCIL Reckitt Benckiser S Cleansing and prevention of infection of all types of lesions incl. minor skin disorders or 2 blisters and minor burns and wounds. Antifungal. Tolnaftate 1%, chlorhexidine (HCl) V Apply to affected area. A 0.25%. Powder. 55g, 3.80. 2K S Athlete’s foot. ALSO SAVLON ANTISEPTIC LIQUID Cetrimide V Apply night and morning, continue 2.25%, chlorhexidine gluconate 0.225%. treatment for at least one week after infection Concentrate for cutaneous solution. 250ml, A1.52; has cleared. 500ml, A2.04. 2 S Topical antiseptic for prevention and ALSO MYCIL OINTMENT Tolnaftate 1%, management of infection or superficial skin benzalkonium Cl 0.1%; oint. 25g, A2.42. trauma. V Rub gently into affected parts night and V Dilute 2 capfuls to v litre of warm water before use. morning. Continue treatment for at least a week 2K after infection has cleared. 2 ALSO SAVLON DRY ANTISEPTIC Povidone iodine A ALSO MYCIL SPRAY Tolnaftate 1%. 150ml, 3.80. 1.14% (5% available iodine content in the powder). Pressurised cutaneous spray powder. V Apply night and morning.Continue Orange/brown micronised powder and treatment for at least one week after infection propellants. A3.40. has cleared. S Topical prophylaxis and treatment of MYCOSTATIN BMS superficial infections or injuries of skin. Q Not recommended for regular use in 2OY neonates. Antifungal. Nystatin 100 000 units/g. Cream. 15g, V Apply to affected area by spraying from A1.58. a distance of 15 to 22cm. Renal impairment: Avoid S Cutaneous and mucocutaneous regular application to inflamed or broken skin. candidosis. D Contact with eyes, ears, mouth or other V Apply 2-4 times daily. mucosa. Spray: Thyroid disorders. Preterm A Allergic reactions, local irritation, neonates (gestational age Q32 weeks; weight erythema multiforme. Q1500g). B Spray: Iodine absorption may interfere NIZORAL McNeil Healthcare with thyroid function tests. Application to extensive areas of broken skin may lead to 2O excessive absorption of iodine. Imidazole antifungal. Ketoconazole 2%; white, C Spray: Avoid lithium. odourless cream. 30g, A4.41. A Spray: Skin irritation. S Dermatophyte infections of skin incl. Tinea spp., Trichophyton spp., Microsporum spp. TROSYL Pfizer and Epidermophyton spp. Cutaneous candidosis 2MO and pityriasis versicolor. V Apply once or twice daily. Imidazole antifungal. Tioconazole 28%; Clear, pale 2O yellow soln. for topical application. 12ml with ALSO NIZORAL SHAMPOO Ketoconazole 2%. Pink applicator, A29.89. S Topical treatment of nail infections due viscous shampoo. 120ml, A3.96. S Seborrhoeic dermatitis of the scalp and to susceptible fungi (dermatophytes, yeasts). V Apply to affected nails and surrounding body and pityriasis versicolor. skin 12 hourly. Duration of treatment 6-12 months V Wash affected area and leave for 3-5 min. before rinsing. Treatment should be repeated according to response. twice weekly for 2-4 weeks. Prophylaxis, use once D Pregnancy, lactation. B Not for opthalmic use. every 1-2 weeks. A Local iritation. B Avoid eyes. C To prevent rebound effect after VIRALIEF Clonmel stopping prolonged treatment with topical 2K corticosteroids, continue applying steroid and Herpes-specific enzyme inhibitor. Aciclovir 5% 2g, reduce over 2-3 weeks. A3.74. A Skin irritation.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
285
15.3 SCABIES
DERMATOLOGY
TREATMENTS
S Herpes simplex infections of the skin. V Apply 5 times daily at 4 hour intervals for 5 days. Continue for further 5 days if healing not complete. B Not for use in eyes. Pregnancy, lactation. A Transient burning or stinging following application. Erthema and flaking with tropical use. Rarely contact dermatitis.
ZOVIRAX
A5.34. S Scabies. V After a hot bath apply to whole body except head and face. Repeat application after 24 hours, and then wash off on the following day. D Acute exudative dermatitis. B Avoid eyes, broken skin or weeping skin conditions.
LYCLEAR CREME RINSE
Herpes-specific enzyme inhibitor. Aciclovir 5%. (GMS)2g, A3.56; 10g, A17.84; (OTC)2g, A3.56; Pump pack 2g, A4.89. S Herpes simplex infections of the skin. V Apply 5 times daily at 4 hourly intervals for 5 days. Continue for further 5 days if healing not complete. B Not for use in eyes. A Erythema and flaking with topical use.
Pediculicide. Permethrin 1%; conditioner. Rinse with comb-59ml, A3.42. S Head lice. V Under 6 months, not recommended; over 6 months, shampoo, rinse and towel dry hair as normal. Apply enough conditioner to saturate hair and scalp. Leave for 10 mins., then rinse thoroughly and comb through while wet. D Pregnancy, lactation. B Avoid eyes.
15.3 SCABIES TREATMENTS
LYCLEAR DERMAL CREAM
DERBAC-M
SSL Healthcare
2KO
COCOIS
UCB
Chefaro 2 O
GSK 2
2NO
children. Removal of previous scalp applications. (Use as a shampoo daily if necessary. Wet hair, massage into the scalp, leave for a few minutes. Rinse, repeat producing a rich lather, rinse again thoroughly and dry.) B Avoid eyes. If irritation occurs discontinue treatment.
GSK
2OY Scabicide. Permethrin 5%. Cream. 30g, A5.92. S Scabies. Pubic lice infestations. P Apply up to 30g as a single application over whole body, except head and face. Wash thoroughly 8-24 hours later. Repeat once if necessary. Q Under 2 months, not recommended. 2 months-1 year, up to 4 g. 1-5 years, up to 7.5 g. 512 years, 15 g. B Avoid eyes. Elderly. A Burning, stinging.
Antipruritic/keratolytic. Coal tar 12%, sulphur 4%, salicylic acid 2% in coconut oil; oint. 40g, A4.93; 100g, A9.44. S Psoriasis and eczema of the scalp, seborrhoeic dermatitis, dandruff. P Apply to scalp, shampoo after 1 hour. Use daily for 3-7 days then intermittently. Q Under 6 years not recommended; over 6 years, same as adult. D Acute infections, pustular psoriasis. B Avoid contact with eyes, mucous membranes, acutely inflammed areas.
DELTASORALEN
Delta
2
Photochemotherapeutic agent. Methoxsalen 10mg. white round tab., marked ‘‘M’’. 30, A10.79; 100, A31.74. S Psoriasis, idiopathic leucoderma, vitiligo, mycosis fungoidis. P Under 50kg, 20mg; 50-65kg, 30mg; 6680kg, 40mg; 81-90kg, 50mg; 91-115kg, 60mg; Over 116kg, 70mg. All two hours before exposure to artificial UV light. Q Not recommended. D Pregnancy, hepatic insufficiency, QUELLADA M Stafford-Miller diabetes mellitus, lupus erythematosus or porphyria. 2O B Concurrent admin. of drugs which cause Pediculicide/scabicide. Malathion 0.5%; liquid. photosensitisation. Protect eyes from U.V. A 200ml, 5.05. S Head and pubic lice. Scabies. Head lice, A Slight nausea _ relieved by milk. apply liberally and leave for 12 hours then DITHROCREAM Dermal shampoo hair. Pubic lice, apply to all areas incl. beard and moustache. Leave for 1-12 hours before 2 M O washing off. Scabies, apply to whole body except Antipsoriatic. Dithranol 0.1%, 0.25%; cream. 0.1%50g, A4.71; 0.25%-50g, A5.05. EURAX Novartis Consumer face and scalp and leave for 24 hours before washing off. off during the 24 hours. S Sub-acute and chronic psoriasis. 2 B Infants under 6 months. Avoid eyes. 2MO Scabicide. Crotamiton 10% lotion and cream. Lotion-100ml, A3.83; Cream-30g, A3.09; 100g, VIRALIEF Clonmel ALSO DITHROCREAM FORTE Dithranol 0.5%; cream. 50g, A5.81. 2K V Start treatment with 0.1% cream. PRESCRIBING NOTES Herpes-specific enzyme inhibitor. Aciclovir 5% 2g, Increase strength according to tolerance and SCABIES A3.74. response. For short contact use, apply once daily Scabies is caused by the mite Sarcoptes scabei, S Herpes simplex infections of the skin. and wash off after v _1 hour. Alternatively, apply and can be treated with benzyl benzoate, V Apply 5 times daily at 4 hour intervals at night and wash off in the morning. malathion, permethrin and crotamiton. All for 5 days. Continue for further 5 days if healing 2 MO members of the household should be treated not complete. ALSO DITHROCREAM HP 1% Dithranol 1%; together. Treatment should be applied to the B Not for use in eyes. Pregnancy, cream. 50g, A6.77. whole body. Patients should not wash their lactation. 2MO hands as it will require reapplication. Itching A Transient burning or stinging following associated with scabies can persist for some application. Erthema and flaking with tropical use. ALSO DITHROCREAM 2% Dithranol 2%; cream. 50g, A8.47. weeks after infestation eliminated; treatment Rarely contact dermatitis. V Apply as above but usually only for 30 with crotamiton can be useful in controlling 15.4 P SORIASIS AND ECZEMA mins._1 hour before washing off. itching. Head and pubic lice, Pediculus humanus D Acute psoriasis. PREPARATIONS capitis are treated with carbaryl, malathion, A Skin irritation, hypersensitivity. permethrin and phenothrin. Resistance is
Pediculicide/scabicide. Malathion 0.5%. Emulsion 50ml, A2.01; 200ml, A5.05. S Head and pubic lice. Scabies. V Head lice, apply liberally and leave to dry naturally. Shampoo hair next day comb before drying. Pubic lice, apply to all areas incl. beard and moustache. Leave for 1-12 hours before washing off. Scabies, apply liberally and leave for 24 hours before washing off. D Treat children under 6 months only on medical advice B Protect eyes during application and washing. Wear rubber gloves to apply product. Treat all household members simultaneously. If accidentally swallowed, contact doctor or hospital immediately. Avoid prolonged application. Use not more than once a week and not more than 3 consecutive weeks. Do not apply to damaged skin except on medical advice. Pregnancy or lactation.
developing. Patients should be encouraged to use the ‘wet combing method’ to mechanically remove lice and eggs. This process should take about 30 minutes if carried out correctly and should be repeated approximately every 4 days for two weeks to break the louse life cycle. References available on request.
286
CAPASAL SHAMPOO
Dermal
2K
DOVOBET
Keratolytic/emollient/anti-pruritic. Salicylic acid 0.5%, coconut oil 1%, distilled coal tar 1%; shampoo. 100ml, A3.48; 250ml, A6.96. S Dry scaly scalp conditions incl. seborrhoeic eczema, seborrhoeic dermatitis, pityriasis capitis, psoriasis and cradle cap in
Antipsoriatic (vit. D derivative)/potent steroid. Calcipotriol (hydrate) 50mcg, betamethasone (dipropionate) 0.5mg per g. Oint. 60g, A48.44; 120g, A96.87. S Initial topical treatment of stable plaque
LEO Pharma
2NO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY
PSORIASIS AND
psoriasis vulgaris amenable to topical therapy. P Apply once daily. Recommended duration 4 weeks; after can be repeated under medical supervision. Max. 15g daily or 100g weekly. Q Under 18 years, not recommended. D Disorders of Ca++ metabolism. Viral lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers, wounds, perianal and genital pruritus. Guttate, erythrodermic, exfoliative and pustular psoriasis. Severe renal insufficiency or severe hepatic disorders. B Avoid scalp, face, mouth and eyes. Wash hands after application. Avoid use on more than 30% of body surface, large areas of damaged skin, under occlusive dressings, mucous membranes, skin folds. Skin of the face and genitals, avoid long-term use. Pregnancy, lactation (do not use on breast). C Other steroids (avoid). A Pruritus, rash, local reactions.
DOVONEX
2NO Antipsoriatic (vit. D derivative). Calcipotriol 50mcg/ g. Cream. 120g, A36.54. S Treatment of plaque psoriasis (psoriasis vulgaris). May be used in combination with topical corticosteroids. P Apply once to twice daily. Initially twice daily reducing to once daily; max. 100g per week.In combination with corticosteroids, admin. Dovonex in the morning and steroid in the evening. Q Apply to affected area twice daily. Over 12 years, max. weekly dose 75g; 6-12 years, max. weekly dose 50g; under 6 years, max. safe dose has not been established.
2NO
ALSO DOVONEX SCALP SOLUTION Calcipotriol 50mcg/ml. Lotion. 60ml, A25.01. S Scalp psoriasis. P Apply twice daily to affected areas. Max. 60ml weekly; when using the scalp soln. together with cream and oint. max. total dose calcipotriol 5mg per week. Q Not recommended. D Disorders of Ca++ metabolism. B Wash hands after application. Do not LEO Pharma use on face. Severe renal failure or severe hepatic
PRESCRIBING NOTES PSORIASIS Psoriasis is a chronic skin disease characterised by scaling and inflammation. Scaling occurs when cells in the outer layer of the skin reproduce faster than normal and pile up on the skin’s surface. Treatments can be topical creams and ointments, phototherapy or systemic treatments in the most serious cases. Topical Treatments: Short-term treatment with corticosteroids is often effective in improving but not completely clearing psoriasis. If less than 10% of the skin is involved, treatment with a high-potency corticosteroid ointment can be considered. High-potency steroids may also be used for treatment-resistant plaques, particularly those on the hands or feet. Long-term use or overuse of high-potency steroids can lead to worsening of the psoriasis, thinning of the skin, internal side effects, and resistance to the treatment’s benefits. Medium-potency corticosteroids may be used on the torso or limbs; low-potency preparations are used on delicate skin areas. Calcipotriol is a vitamin D3 analogue and controls excess production of skin cells. It is recommended for the treatment of plaque psoriasis but is not recommended for the face or genital areas. It can be applied once daily or twice daily. It is not recommended in pregnancy. The combination of calcipotriol with the potent steroid betamethasone dipropionate has a once daily application for the treatment of plaque psoriasis. It is not recommended in pregnancy or children. Calcitriol is another vitamin D analogue which is indicated for the topical treatment of mild to moderately severe plaque psoriasis with up to 35% of body surface involvement. Coal tar may be applied directly to the skin, used in a bath solution, or used on the scalp as a shampoo. The most potent forms may be irritating. It is sometimes combined with ultraviolet B (UVB) phototherapy. Compared with steroids, coal tar has fewer side effects, but it is messy and less effective and thus is not popular with many patients. Other drawbacks include its failure to provide long-term help for most patients, its strong odour, and its tendency to stain skin or clothing. Dithranol has been used in the treatment of sub-acute and chronic psoriasis for over 70 years. This treatment often fails to adequately clear lesions, may irritate the skin, and it stains skin and clothing brown or purple. It is unsuitable for acute or actively inflamed eruptions. Topical retinoid tazarotene is a fast-drying, clear gel. It does not act as quickly as topical corticosteroids, but has fewer side effects. It is irritating to normal skin, so should be used with caution in skin folds. Women of childbearing age should use birth control when using tazarotene. Salicylic acid is used to remove scales, and is most effective when combined with topical steroids, dithranol, or coal tar. Systemic Treatments: More severe forms of psoriasis are treated systemically. Methotrexate slows cell production by suppressing the immune system and should be administered under hospital supervision. Ciclosporin taken orally acts by suppressing the immune system in a way that slows the rapid turnover of skin cells. It provides quick relief of symptoms, but is only effective during the course of treatment. The best candidates for this therapy are those with severe psoriasis who have not responded to or cannot tolerate other systemic therapies. Ciclosporin may impair kidney function or cause hypertension, and is not recommended for patients who have a weak immune system, or who have had substantial exposure to UVB or PUVA in the past, or who are pregnant or breast-feeding. Acitretin is an oral retinoid (vitamin-A derivative) that may be used in severe cases of psoriasis that do not respond to other therapies. Because this treatment also may cause birth defects, women must protect themselves from pregnancy beginning 1 month before and 3 years after treatment. Most patients experience a recurrence of psoriasis after acitretin is discontinued. It should only be administered under hospital supervision. Psoriasis is a disease driven by T cells. T-cell activation releases interleukin-2 and tumour necrosis factor a (TNF-a), one of the key cytokines that triggers and sustains the inflammation response. TNF blockers etanercept and infliximab, and T-cell blocker efalizumab are indicated for adults with moderate to severe plaque psoriasis where other systemic therapies including ciclosporin, methotrexate or PUVA are inadequate. References available on request. Updated August 2007
ECZEMA PREPARATIONS
15.4
disorders (avoid). Pregnancy, lactation (avoid). A Various skin reactions.
EFALITH
Scotia
2MO Anti-inflammatory. Lithium succinate 8%, zinc sulphate 0.05%; oint. 20g, A15.80. S Seborrhoeic dermatitis. P Apply thinly and evenly and rub in gently, twice daily in morning and evening. Q Not recommended. B Avoid eyes and mucous membranes. Psoriasis. A Local irritation.
ENBREL
Wyeth
2MT Tumour necrosis factor (TNF) antagonist. Etanercept 25mg. Vial containing powder and solvent for soln. for inj. or pre-filled syringe. Price available on request. S Adults with moderate to severe plaque psoriasis where other systemic therapy incl. cyclosporine, methotrexate or PUVA is inadequate. P 25mg SC twice weekly. Alternatively, 50mg twice weekly for up to 12 weeks followed. Continue until remission for up to 24 weeks. Discontinue if no response after 12 weeks. D Sepsis or risk of sepsis. Active infections incl. chronic or localised infections. Treatment of Wegener’s granulomatosis. Pregnancy, lactation. B Evaluate for infections before, during, and after treatment. Monitor new infections (discontinue if serious). History of recurring or chronic infections or predisposing conditions (incl. advanced or poorly controlled diabetes). Serious infections, sepsis, tuberculosis, and other opportunistic infections, have been reported. Evaluate for tuberculosis before treatment. Do not initiate in active tuberculosis. Treat latent tuberculosis before initiation. May reactivate hepatitis B virus in chronic carriers (monitor). May worsen hepatitis C. CHF, history of blood dyscrasias. Existing or risk of CNS demyelinating disease. Risk of lymphoma development cannot be excluded (reported rarely). Non-melanoma skin cancer (NMSC) reported in patients treated with TNF-antagonists; periodic skin examination recommended for all patients at increased risk for NMSC (incl. patients with psoriasis or history of PUVA therapy). Caution: Moderate to severe alcoholic hepatitis; do not use to treat alcoholic hepatitis. C Anakinra, abatacept or live vaccines (not recommended). Sulfasalazine. A Inj. site reactions. Infections (e.g. upper RTIs, bronchitis, cystitis, skin infections). Pruritus, fever, allergic reactions, autoantibody formation.
EXOREX
Forest
2KO Antipsoriatic. Coal tar 5%. Alcoholic extract, cutaneous emulsion. 100ml, A13.65, 250ml, A27.30. S Treatment of psoriasis of skin and scalp. P Apply thin layer 2 or 3 times daily. R Dilute lotion with few drops boiled water and apply as for adults. V 1-12 years, same as elderly; over 12 years, same as adults. D Folliculitis, acne vulgaris, photosensitivity (SLE, sunlight allergy), inflamed or broken skin. B Avoid eyes, mucous membranes, genital/
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
287
15.4 PSORIASIS
DERMATOLOGY
AND ECZEMA PREPARATIONS
max. 8 weeks. An initial dose of 5mg/kg per day in two divided doses may be used when rapid improvement is required. HUMIRA Abbott Q Not recommended. D Impaired renal function, uncontrolled 2NT hypertension, uncontrolled infection. Malignancy Tumour necrosis factor (TNF) antagonist. Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled other than of the skin. B Only use under specialist supervision. pen or pre-filled syringe (2 per pack). Price on PUVA or UVB therapy. Closely monitor renal and request. liver function, BP and serum lipids, serum K+. S Moderate to severe chronic plaque psoriasis where response to other systemic therapy Hyperkalaemia, hyperuricaemia. Skin malignancy. including cyclosporine, methotrexate or PUVA was Active herpes simplex infections should be cleared before treatment. Advise patients to avoid inadequate. sunbathing. Pregnancy, lactation. Not P 80mg at week 0, followed by 40mg at bioequivalent to Sandimmun; specify brand when week 1; and then 40mg once fortnightly via SC prescribing. injection. C Systemic antibiotics, live vaccines, Q Under 18 years, not recommended. phenytoin, ketoconazole, fluconazole, D Active tuberculosis, other severe itraconazole, erythromycin, rifampicin, infections (sepsis), uncontrolled / opportunistic carbamazepine, barbiturates, Ca++ antagonists, infections. Moderate to severe HF. Pregnancy, HMG-CoA reductase inhibitors, colchicine, lactation. B Monitor for infections, incl. tuberculosis, nephrotoxic drugs, oral contraceptives, prednisolone, methylprednisolone, before, during and after treatment; discontinue if propafenone, K+suppl., K+sparing diuretics, lipid solutions, serious. Do not initiate if active, chronic or localised infection unless controlled. Pre-existing or NSAIDs, doxycycline, sulphadiazine, IV recent-onset CNS demyelinating disorders, mild HF sulphadimidine, IV trimethoprim, diclofenac, nifedipine, grapefruit juice. (caution), COPD, heavy smokers. Use adequate contraception, avoid breastfeeding and pregnancy A Renal and hepatic dysfunction, hypertension, tremor, GI disturbances, for 5 months after last treatment. Malignancies hypertrichosis, gingival hypertrophy, malignancies, incl. lymphoma, demyelinating disease, HBV lymphoproliferative disorders, burning sensations reactivation, pancytopenia reported. (feet and hands), fatigue, muscle weakness or C Increased antibody formation and cramp, myopathy. Rarely hyperkalaemia, Humira clearance when admin. without hyperuricaemia, hypomagnesaemia, methotrexate. Live vaccines, anakinra (not hypercholesterolaemia, oedema, convulsions, recommended), immunosupressants (caution). headache, rash, mild anaemia, haemolytic uraemic A Inj. site reaction, upper and lower syndrome, weight gain, pancreatitis, colitis, respiratory infections, viral/bacterial infections, paraesthesia, neuropathy, confusion, candidiasis, dizziness, headache, neurological dysmenorrhoea, amenorrhoea, gynaecomastia, sensation disorders. Cough, nasopharyngeal pain, encephalopathy. diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, NEOTIGASON Actavis rash, pruritus, dermatitis, eczema, hair loss, 2NO musculoskeletal pain, pyrexia, fatigue. Vitamin A derivative. Acitretin 10mg; 25mg. Resp. METED Alliance brown cap/white body or brown cap/yellow body. Both with actavis logo on cap and strength on 2 body. 10mg-60, A31.35. 25mg-60, A72.80. Antiseptic/keratolytic. Salicylic acid 3%, colloidal S Severe, extensive refractory psoriasis; sulphur 5%; liquid. 120ml, A5.28. palmo-plantar pustular psoriasis; severe congenital S Seborrhoeic dermatitis, psoriasis of the ichthyosis; severe Darierâ&#x20AC;&#x2122;s disease; severe lichen scalp, dandruff. planus. P Use as shampoo at least twice weekly. P Initially 25-30mg daily with food, A Irritation. adjusting according to response. Max. 75mg daily. NEORAL Novartis Maintenance, 25-50mg daily. Q 0.5mg/kg daily. Max. 1mg/kg daily for a 2MT limited time only. Fungal metabolite immunosuppressant. D Pregnancy, lactation. Renal or hepatic Cyclosporin 25mg blue-grey oval cap., 50mg impairment. Elevated blood lipid values. yellow-white oblong cap.; 100mg blue-grey B Teratogenic. Contraceptive measures oblong cap. All marked with S in a triangle and must be taken during and for at least 2 years after cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; treatment. Avoid blood donation for min. 1 year 100mg-30, A96.03. after treatment. Diabetes. Monitor liver function 2MT and serum cholesterol and triglycerides. Bone ALSO NEORAL ORAL SOLUTION Cyclosporin changes on long term therapy. Contains glucose. 100mg/ml. Oral soln. 50ml, A143.89. C Tetracyclines, high dose vit. A, S Severe psoriasis or severe atopic methotrexate. dermatitis where standard therapy is ineffective or A Paronychia, headache, dry eyes, inappropriate. flushing, nasal dryness, epistaxis, rhinitis, dry P Psoriasis, initially 1.25mg/kg twice daily. mouth, gingivitis, stomatisis, GI disorder, dry skin, If necessary after 1 month, increase gradually up erythema, pruritus, alopecia, skin exfoliation, skin to max. 5mg/kg daily in two divided doses. atrophy, skin fragility, sticky skin, dermatitis, Discontinue therapy if ineffective within 6 weeks abnormal hair texture, onychoclasis, hyperhydrosis, on 5mg/kg daily. An initial dose of 5mg/kg daily in arthralgia, myalgia, oedema peripheral, increased two divided doses when rapid improvement blood cholesterol, increased triglycerides, required. Dermatitis, 1.25-2.5mg/kg twice daily for abnormal liver function test. rectal areas. Pregnancy, lactation. A Skin irritation, photosensitivity.
288
NEUTROGENA T-GEL SHAMPOO McNeil Healthcare 2K Keratolytic/antipruritic/antiseptic. Refined coal tar 5mg/ml. Shampoo. 125ml, A3.49; 250ml, A5.59. S Symptomatic treatment of dandruff and seborrhoeic dermatitis of the scalp. P Cutaneous use only. Apply liberally and massage into wet scalp, leave for several min. Rinse, repeat application and rinse thoroughly. Use once or twice weekly for 4 weeks. Treatment q 4 weeks, under medical supervision. Q Under 12 years, contra. D Acutely inflamed or broken skin. Use in children under 12 years. B If irritation develops, discontinue and consult physician. Avoid contact with eyes. Rarely, temporary discoloration of blond, bleached or tinted hair may occur. Pregnancy, lactation (only if benefit outweighs risk).
PENTRAX
Alliance
2 Antipsoriatic. Coal tar 4.3% (7.71% Fractar). Liquid. 120ml, A5.28. S Seborrhoeic dermatitis, psoriasis of the scalp, dandruff. V Use as shampoo once to twice weekly. A Irritation.
POLYTAR LIQUID
Stiefel
2 Antipsoriatics. Tar 0.3%, cade oil 0.3%, coal tar soln. 0.1%, arachis oil ext. of coal tar 0.3%, oleyl alcohol 1%; liquid. 150ml, A2.87; 250ml, A3.71. S Seborrhoea, dandruff. Psoriasis of scalp. Eczema. V Use as shampoo once or twice weekly.
PROTOPIC
Astellas
2NO Topical immunomodulator. Tacrolimus monohydrate 0.03%, 0.1%; oint. 0.03%-30g, A27.54; 60g, A52.32; 0.1%-30g, A30.60; 60g, A58.19. S Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies (e.g. topical corticosteroids). Maintenance treatment to prevent flares and to prolong flare-free intervals in patients experiencing a high frequency of disease exacerbations (q 4 or more times per year) who have had an initial response to a max of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). P Treatment: Start treatment with 0.1% twice a day until clearance of the lesion. If symptoms recur, restart twice daily treatment with 0.1%. Consider reducing frequency or strength to 0.03% if clinical condition allows. Consider other treatment options if no signs of improvement after 2 weeks. Maintenance: Apply 0.1% to commonly affected areas once a day, twice weekly leaving 2-3 days between applications. If flare reoccurs, re-initiate twice daily treatment. Review treatment after 12 months. Q r2 years:Treatment: 0.03% twice a day for up to 3 weeks. Thereafter reduce to once a day until clearance of lesion. Maintenance: Apply 0.03% to commonly affected areas once a day, twice weekly leaving 2-3 days between applications. If flare reoccurs, re-initiate twice daily
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY treatment. Review treatment after 12 months. r 16 years, as per adults. D Hypersensitivity to macrolides. Pregnancy, lactation. Patients with genetic epidermal barrier defects. Occlusive dressings. Congenital or acquired immunodeficiencies, immunosuppression. B Protect from sunlight or UV light. Concomitant use with other topical preparation. Hepatic failure, erythroderma. Clinical infections should be cleared before use. Malignancies (incl. cutaneous and other types of lymphoma, skin cancers) reported. C Caution: Vaccination. A Application site reactions (e.g. burning, pruritus, irritation, pain), paraesthesias, dysaesthesias, alcohol intolerance (facial flushing or skin irritation), folliculitis, herpes simplex infections.
PSORIASIS AND
ECZEMA PREPARATIONS
15.4
dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC homeostasis, kidney or liver dysfunction, tissue disorders, fatigue, chest pain, fever, elevated hypercalcaemia, abnormal calcium metabolism. B Apply to the face with caution, avoid hepatic transaminases, inf. reactions. contact with eyes. Wash hands after application. SANDIMMUN Novartis Do not cover with occlusive dressing. Sensitivity or severe irritation. 2MT C Medications known to increase the Fungal metabolite immunosuppressant. serum Ca++ level, such as thiazide diuretics. Cyclosporin 25mg pale pink oval cap., 50mg Caution in patients receiving calcium suppl. or yellow oblong cap.; 100mg dusky pink oblong cap. high doses of vit. D. 25mg-30, A29.01. 50mg-30, A53.77. 100mg-30, A Skin irritation (reddening, itching), A105.50. discontinue if severe irritation occurs. 2NT
ALSO SANDIMMUN ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A129.09. S Severe psoriasis or severe atropic dermatitis where standard therapy is ineffective or in appropriate. V See lit. D Hypersensitivity to cyclosporin. Uncontrolled hypertension, uncontrolled infection. PSORIDERM BATH EMULSION Malignancy. Dermal B Monitor renal and liver function, BP and 2O serum lipids. Hyperkalaemia, hyperuricaemia. Antipsoriatic. Coal tar 40%; bath emulsion. 200ml, Pregnancy, lactation. A3.49. C Systemic antibiotics, live vaccines, phenytoin, ketoconazole, fluconazole, S Sub-acute and chronic psoriasis. itraconazole, erythromycin, rifampicin, 2O carbamazepine, barbiturates, Ca++ antagonists, ALSO PSORIDERM CREAM Coal tar 6%, lecithin HMG-CoA reductase inhibitors, colchicine, 0.4%. 225ml, A3.96. nephrotoxic drugs, oral contraceptives, V Rub in twice daily. propafenone, prednisolone, methylprednisolone, 2 K+suppl., K+sparing diuretics, lipid solutions, ALSO PSORIDERM SCALP LOTION Coal tar 2.5%, NSAIDs. lecithin 0.3%. 250ml, A8.35. A Renal and hepatic dysfunction, tremor, V Wet hair and use as a shampoo. GI disturbances, hypertrichosis, gingival D Acute psoriasis. hypertrophy, burning sensations (feet and hands), A Skin irritation, photosensitivity. fatigue, muscle weakness or cramp, myopathy, REMICADE Schering-Plough malignancies, lymphoproliferative disorders. Rarely hyperkalaemia, hyperuricaemia, 2N hypomagnesaemia, oedema, convulsions, Monoclonal antibody. Infliximab 100mg. Powder headache, rash, mild anaemia, haemolytic uraemic for conc. for soln in vial. 1, A690.43. syndrome, weight gain, pancreatitis, colitis, S Moderate-severe plaque psoriasis in paraesthesia, neuropathy, confusion, adults failing to respond/with a contraindication/ dysmenorrhoea, amenorrhoea, gynaecomastia, intolerant to other systemic therapy incl. encephalopathy. cyclosporine, methotrexate, PUVA. P 5mg/kg IV inf. over 2 hrs followed by SELSUN Chattem 5mg/kg inf. at 2 and 6 weeks, then every 8 weeks. 2 If no response after 14 weeks, discontinue. Antidandruff agent. Selenium sulphide 2.5%. Q Under 17 years, not recommended. Shampoo. 50ml x 6, A11.25; 100ml x6, A16.90. D TB (must be screened for active/ S Dandruff and seborrhoea capitis. inactive), severe infections eg. sepsis, abscesses. Moderate/severe HF. Women should use adequate Q Under 5 years, not recommended. V Massage and leave for 2-3 mins. Use contraception and should not breastfeed during twice weekly for 2 weeks, then weekly for next 2 treatment and within 6 months of last dose. B Monitor for acute inf. reactions during/ weeks. D Pregnancy (1st trim.), lactation. within a few hours of inf. If necessary interrupt B Do not use within 2 days of perming or immediately. Ensure emergency equip. and dyeing. Discontinue if irritation occurs. treatment available. Monitor patients retreated after a long period. Caution: Chronic infection or SILKIS Galderma recurrent infections. Discontinue if patient 2NO develops symptoms of lupus-like syndrome, antiVit. D analogue. Calcitriol 3mcg per g. Oint. 100g, nuclear antibodies or serious infection. Elderly, A21.29. hepatic impairment, mild heart failure. Increased risk of malignancies (caution with heavy smokers, S Topical treatment of mild to moderately severe plaque psoriasis (psoriasis vulgaris) with up history of malignancy). UC patients: Regularly to 35% of body surface involvement. screen for dysplasia. Crohn’s: Rare cases of P Apply to affected area twice daily, in hepatosplenic T-cell lymphoma reported. the morning and evening before retiring and after Paediatric Crohn’s: If possible, bring up to date washing. It is recommended that not more than with all vaccinations before initiating Remicade 35% of body surface be exposed to daily therapy. treatment. Max. 30g per day for no more than 6 C Anakinra, live vaccines (not weeks. recommended). Q Not recommended. A Viral infection, serum sickness-like D Patients on systemic treatment of Ca++ reactions, headache, vertigo, flushing, RTIs,
SOLARAZE
Shire
2MO NSAID. Diclofenac Na+ 3% w/w. Gel. 25g, A20.32. S Actinic keratoses. P Apply locally to skin twice daily. Usually 0.5g on 5cm x 5cm lesion site. Duration 60-90 days. Max: 8g daily. Q Not recommended. D Hypersensitivity to aspirin or NSAIDs (asthma, allergic rhinitis, urticaria). Pregnancy, lactation. B GI ulceration or bleeding, reduced heart rate, liver or renal function. Avoid contact with eyes. Do not apply to skin wounds, infections, exfoliative dermatitis. Avoid direct sunlight and solarium use. A Pruritus, rash, application site reactions, dry skin, paraesthesia, erythema, hyperaesthesia, oedema, skin ulceration, contact dermatitis, hypertonia, tingling, vesiculobullous rash, skin hypertrophy, eczema, conjunctivitis.
STELARA
Janssen-Cilag
2T Interleukin inhibitor. Ustekinumab 45mg/0.5ml. Clear to slightly opalescent, colourless to light yellow sln for inj. Price on request. S Moderate to severe plaque psoriasis in adults who failed to respond to, or with a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA. P Initially, 45mg dose by SC inj. at week 0, followed by 45mg dose at week 4, then every 12 weeks thereafter. Consider discontinuation if no response after 28 weeks. Body weight q100kg: Initially, 90mg dose administered subcutaneously at week 0, followed by 90mg dose at week 4, then every 12 weeks thereafter. Q Under 18 years, not recommended. D Clinically important, active infection. Pregnancy, lactation. B May increase risk of infections and reactivate latent infections. May increase malignancy risk. Caution: Elderly, infection or history of recurrent infection, history of malignancies. Monitor for tuberculosis infection prior to, during and after treatment. Discontinue if anaphylactic / other serious allergic reactions occur. C Not recommended: Live vaccines. Caution: Immunosuppressants. A Upper RTI (incl. viral), nasopharyngitis, cellulitis, depression, dizziness, headache, pharyngolaryngeal pain, nasal congestion, diarrhoea, pruritus, back pain, myalgia, fatigue, inj. site erythema.
STIEPROX
Stiefel
2MO Broad spectrum antifungal. Ciclopiroxolamine
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
289
15.5 ACNE
DERMATOLOGY
AND ROSACEA PREPARATIONS
1.5%; shampoo. 100ml, A8.47. S Scalp disorders such as dandruff and seborrhoeic dermatitis. P Apply to wet hair to produce an abundant lather and massage scalp and adjacent areas. Rinse thoroughly and repeat procedure. Use two or three times weekly or as required. Q Not recommended. B Avoid contact with eyes. Pregnancy, lactation. A Rarely skin irritation.
P Lather with warm water, massage into skin two or three times daily, then rinse. A Irritation, salicylism.
ALSO DIFFERIN CREAM Adapalene 0.1%. Cream. 30g, A7.95. S Mild to moderate acne vulgaris where comedones, papules and pustules predominate. BREVOXYL Stiefel P Wash and dry affected area. Apply thin film once daily at bedtime. Reassess after 3 2 months. Anti-bacterial-keratolytic. Benzoyl peroxide 4%; Q Not recommended. cream. 40g, A4.30. D Severe acne, broken skin, eczema. S Mild to moderate acne. P Wash affected area, then apply once or Pregnancy (unless essential); adequate contraception must be used. twice daily. B Avoid eyes, lips, angle of nose, mucous Q Not recommended. XAMIOL LEO Pharma B Avoid eyes, mouth and mucous membranes, excessive exposure to sunlight. Lactation. 2NO membranes. C Retinoids. A Transient irritation and peeling. Antipsoriatic (vit. D derivative)/potent steroid. A Dry skin, skin irritation, skin burning Calcipotriol (monohydrate) 50mcg/g, sensation, erythema. Reduce application or BY-MYCIN Ergha betamethasone (dipropionate) 0.5mg/g. Almost withdraw if severe. clear, colourless to slightly off-white gel. 60g, 2NO A46.20. Tetracycline. Doxycycline (hyclate) 50mg. Opaque DUAC ONCE DAILY Stiefel S Topical treatment of scalp psoriasis. pale green/white cap. 28, A3.48. P Apply to affected area once daily for 4 2NO S Acne vulgaris. weeks. Repeat treatment under supervision. Antibiotic/antibacterial. Clindamycin phosphate P 1 daily with food or fluid for a min. of Q Under 18 years, not recommended. 1%, anhydrous benzoyl peroxide (as hydrous 6 weeks. D Known disorders of calcium metabolism. Q Not recommended. benzoyl peroxide) 5%. Gel. 25g, A12.92. Viral (e.g. herpes or varicella) lesions of the skin, S Mild to moderate acne vulgaris, D Pregnancy, lactation. Obstructive fungal or bacterial skin infections, parasitic particularly inflammatory lesions. oesophageal disorders. infections, skin manifestations in relation to B Hepatic impairment. Oesophageal reflux P Apply once daily in the evening. tuberculosis or syphilis, perioral dermatitis, Q Under 12 years, not recommended. disorders. Take with plenty of water and remain atrophic skin, striae atrophicae, fragility of skin D Lincomycin sensitivity. Lactation. upright. Prolonged use. veins, ichthyosis, acne vulgaris, acne rosacea, C Penicillin (avoid), methoxyflurane (fatal B Avoid contact with mouth, eyes, mucous rosacea, ulcers and wounds. Guttate, membranes, abraded or eczematous skin. Caution: renal toxicity). Antacids, Ca++, iron, coumarin erythrodermic, exfoliative and pustular psoriasis. History of regional enteritis, ulcerative or anticoagulants, barbiturates, carbamazepine, Severe renal insufficiency or severe hepatic antibiotic-associated colitis (discontinue if occurs), phenytoin. disorders. atopic patients. Minimise exposure to sun or A Tooth discolouration, enamel B Avoid concurrent treatment with other hypoplasia, GI disturbances, oesophagitis, allergic sunlamps. Advise patients that 4-6 week treatment steroids on the scalp. Avoid use on more than may be required. Pregnancy (if benefit outweighs reactions, photosensitivity, superinfections. 30% of body surface, large areas of damaged skin, risk). under occlusive dressings, mucous membranes, DALACIN T Pharmacia C Avoid topical acne products containing skin folds. Increased risk of local and systemic vit. A. Caution: Other topical antibiotics, 2NO corticosteroid undesirable effects with long-term medicated or abrasive soaps/cleansers, products Antibiotic. Clindamycin phos. 10mg/ml. White use. If lesions become secondarily infected, treat with strong drying effect, with alcohol or emulsion or soln. Rollerball lotion -30ml, A7.89; with antimicrobiological therapy; stop treatment if astringents. 50ml, A13.15; Soln-30ml, A6.93; 50ml, A11.55. infection worsens. Risk of generalised pustular S Acne vulgaris, particularly of papular or A Erythema, peeling, dryness, burning, psoriasis or of rebound effects when discontinuing pruritus. pustular type. treatment, continue medical supervision after V Apply thin film twice daily to affected discontinuation. Hypercalcaemia may occur if the EFRACEA Galderma area. maximum weekly dose (100g) is exceeded. Avoid D Lincomycin sensitivity. 2 N O excessive exposure to natural or artificial sunlight. B Avoid eyes and mucous membranes. Doxycycline 40mg (monohydrate). Beige, size 2 Contains butylated hydroxytoluene. Pregnancy, Pregnancy. modified-release hard cap. marked CGPI 40. 56, lactation. C Keratolytics. A30.10 . A Pruritus, local reactions. A Dry skin, dermatitis, folliculitis (soln.). S To reduce papulopustular lesions in Diarrhoea or colitis (discontinue immediately). 15.5 ACNE AND ROSACEA adult patients with facial rosacea. P 40mg daily in morning with adequate PREPARATIONS DIANETTE Bayer Schering amounts of water. Consider stopping treatment if no effect seen after 6 weeks. Assess patients 4 ACNECIDE Galderma 2 M O Oestrogen/progestogen. Ethinyloestradiol 35mcg, weeks after stopping treatment. 2K cyproterone acetate 2mg; beige sug-ctd biconvex D Infants and children up to 12 years. Antibacterial-keratolytic. Hydrous benzoyl tab. 21, A5.58. 2nd, 3rd trimesters of pregnancy. Known or peroxide equiv. benzoyl peroxide 5% w/w. Gel. S Severe acne vulgaris in females; suspected achlorhydria; surgery that bypasses or 60g, A5.99. contraception for females with severe acne excludes duodenum. Lactation (long term use). S Acne vulgaris. vulgaris. B Must not be used to treat infections. V Apply once or twice daily. P Acne: males, not recommended. Not for use in ocular manifestations of rosacea D Pregnancy, lactation (unless essential). Females, 1 daily. First course begins on first day of (ocular rosacea and/or blepharitis/meibomianitis). B Avoid eyes, mucous membranes. Do not menses, with seven day interval between 21 day Caution: Predisposition to candidosis, hepatic apply to damaged skin. Avoid sunlight, UV. courses. impairment, myasthenia gravis. May occur: C Drugs with desquamative, irritant and Q Not recommended. Oesophageal irritation / ulceration, drying effects. D As for combined oral contraceptives. pseudomembranous colitis. Avoid excessive A Transient irritation and peeling. See SPC. sunlight or UV (discontinue if phototoxicity occurs). Discontinue if severe acute hypersensitivity ACNISAL Alliance DIFFERIN Galderma reaction occurs. Contains sucrose. 2 2NO C Drug/food containing bi- or tri-valent Antibacterial-keratolytic. Salicylic acid 2%. Soln. ions (e.g. alum., zinc, Ca++, Mg++, iron, activated Retinoid-like. Adapalene 0.1%. Aqu. gel. 30g, A7.95. 177ml, A5.66. charcoal, cholestyramine, bismuth chelates); take 2-3 hrs following doxycycline. Caution: Quinapril, 2NO S Acne.
290
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Prohibited in men
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Prohibited in specific sports
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Declaration required
DERMATOLOGY rifampicin, barbiturates, carbamazepine, diphenylhydantoin, primidone, phenytoin and chronic alcohol abuse, cyclosporine. Not recommended: Isotretinoin, beta-lactam antibiotics. Caution: Methoxyflurane, sulphonylureas, anticoagulants, oral contraceptives. A Nasopharyngitis, sinusitis, fungal infection, anxiety, sinus headache, hypertension, GI disorders, pain, back pain. Increased: ASAT, BP, blood LDH, blood glucose.
ACNE
AND ROSACEA PREPARATIONS
Macrolide/retinoid. Erythromycin 2%, isotretinoin 0.05%; alc. gel. 30g, A10.80. S Mild to moderate acne vulgaris. P Apply sparingly once or twice daily for min. 6_8 weeks. Q Not recommended. B Avoid eyes, mouth, mucous membranes, abraded or sun burnt skin, build up in skin fold areas. Pregnancy, lactation. C Keratolytics. A Local irritation.
15.5
2NO
Tetracycline. Minocycline (HCl) 100mg. Modified release hard cap. with opaque buff body and opaque brown cap. 56, A29.29. S Acne. P 1 every 24 hours swallowed whole with plenty of fluid, while sitting or standing. Min. duration 6 weeks; max. 6 months. If q 6 months considered necessary, monitor at least three monthly thereafter for signs of hepatitis or systemic lupus erythematosus (SLE) or unusual pigmentation. ISOTREX Stiefel MINOCIN SA Meda Q Over 12 years, as per adults. Under 12 years, not recommended. 2N 2NO D Complete renal failure, severe liver Vitamin A derivative. Isotretinoin 0.05%; alc. gel. Antibiotic. Minocycline (HCl) 100mg. Orange/ 30g, A10.67. brown sust. action cap. marked LEDERLE and 8560. disease. Pregnancy, lactation. B Caution: Mild to moderate hepatic S Mild to moderate acne vulgaris. 56 (8 week Cal/Pk), A33.01. dysfunction, severe renal insufficiency, myasthenia P Apply sparingly once or twice daily for S Acne. gravis, elderly. Monitor organ system function min. 6_8 weeks. P 1 daily swallowed whole. periodically (haematopoietic, renal, hepatic). Q Not recommended. Q Under 12 years, not recommended; over Reported: Auto-immune hepatotoxicity, SLE, D History, or family history of cutaneous 12 years, same as adults. hyperpigmentation, tooth discolouration epithelioma. Pregnancy, lactation. D Pregnancy, lactation. (childrenQ12), photosensitivity, intracranial B Avoid eyes, mouth, mucous membranes, B Hepatic impairment. hypertension with vision disturbances. Crossabraded or sun burnt skin. Avoid UV light. C Antacids, mineral suppl., penicillin, resistance between tetracyclines. Driving/using C Keratolytics. anticoagulants. machines. A Local irritation. A GI disturbances, allergic reactions. C Caution: Alcohol, other hepatotoxic Superinfections. drugs, oral contraceptives, anticoagulants, ISOTREXIN Stiefel diuretics, ergot alkaloids. Avoid penicillin. MINOSIL Pinewood 2NO Antacids, suppl. with iron, Ca++, magn., alum., bismuth and zinc salts; take 3 hours apart. Avoid PRESCRIBING NOTES isotretinoin before, during and shortly after ACNE therapy. Urinary catecholamine tests. Acne is a disease of the sebaceous hair follicle. Under normal circumstances, sebum travels up the hair A Dizziness (lightheadedness). follicle and out to the skin’s surface. In acne, sebum is trapped within the follicle. Acne develops on those areas of the skin where sebaceous glands are most numerous: the face, scalp, neck, chest, back, and upper arms and shoulders. The acne lesions we know as blackheads are called comedones. Red, swollen, pusfilled lesions are called papules, nodules and pustules. Antibiotics may be used topically (erythromycin, clindamycin, tetracycline) or systemically (doxycycline, minocycline, oxytetracyline, tetracycline, erythromycin). Antibiotics work by clearing the skin of Propionibacterium acnes. Topical antibiotics are limited in their ability to penetrate the skin and to clear more deep-seated P. acnes. Systemic antibiotics, which circulate throughout the body and into sebaceous glands, can be used for more severe kinds of acne. Antibiotics do not address the other causative factors in acne and may take several weeks or months to work. Antibiotics are usually used in combination with other drugs that unclog follicles. Systemic antibiotics for acne should not be used during pregnancy; some may reduce the effectiveness of oral contraceptive pills, risking a pregnancy during treatment. Vitamin A derivatives called retinoids, have numerous effects on the skin. Other drugs that work like vitamin A have similar effects. Topical retinoid preparations (tretinoin) help unclog pores to clear up moderate to severe acne by normalizing the way the skin grows and sheds. They can be used in combination with other acne products, such as benzoyl peroxide, and oral antibiotics. Oral retinoid (isotretinoin) reduces sebum output, improves the shedding of skin and reduces the P. acnes population of the skin, thereby intervening in all the causes of acne. It is effective against severe nodular acne, even if it has not previously responded to other treatments. It can have long lasting results, but can also cause significant side effects. It is teratogenic. A course of treatment completed in the past has no effect on future pregnancies, but the drug should not be used in women who believe they may become pregnant during treatment. Oral isotretinoin should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements. Oral contraceptives being female hormones help to counteract the effect of male hormones (androgens) on acne, but their use is limited to female patients. Oral contraceptives contain combinations of hormones, some combinations being more effective than others in clearing acne. The maximum benefit of oral contraceptives on acne occurs in 3 to 4 months. Corticosteroids act by reducing inflammation, usually presented in a combination product. Benzoyl peroxide works by destroying the bacteria associated with acne, namely P. acnes, taking about 2 weeks to work. It must be used continuously to prevent the acne returning, as it does not affect sebum production or the way the skin follicle cells are shed. It works well in milder cases of acne. Salicylic acid corrects the abnormal shedding of cells. In milder acne, salicylic acid helps unclog pores to resolve and prevent lesions. It does not have any effect on sebum production or P. acnes. As with benzyl peroxide, it must be used continuously as its effects cease when treatment stops. Azelaic acid has antimicobial and anticomedonal properties, it can be used as an alternative to benzoyl peroxide as it is less irritant. References available on request.
MINOX 50
Rowex
2NO Tetracycline. Minocycline 50mg. Yellow-brown film-ctd tab. 100, A30.76. S Acne vulgaris. P 50mg twice daily. Q Not recommended. D Pregnancy, lactation. B Hepatic impairment. C Antacids, mineral suppl., penicillins, anticoagulants. A GI disturbances, rarely allergic reactions. Superinfections.
NICAM GEL
Dermal
2K Topical anti-inflammatory. Nicotinamide 4%. Colourless translucent gel. 60g, A11.95. S Topical treatment of mild to moderate acne vulgaris. P V Apply sparingly twice daily. Reduce to once daily or alternate days, if irritation or peeling occurs. B For external use only. Avoid eyes and mucous membranes. Pregnancy and lactation (caution). A Skin dryness or irritation.
PANOXYL
Stiefel
2 Antibacterial-keratolytic. Benzoyl peroxide 5%, 10%; alc. gel. 5%-40g, A3.14. 10%-40g, A3.50. S Acne vulgaris. V Commence treatment with lowest strength. Wash, then apply once daily. B Avoid eyes, mouth and mucous membranes. A Transient irritation and peeling.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
291
15.6 WART
DERMATOLOGY
TREATMENTS
QUINODERM CREAM
Quinoderm
2MO
ALSO ROZEX CREAM Metronidazole 0.75%. 30g, A5.49. Antibacterial/keratolytic. K+ hydroxyquinoline S Acne rosacea in dry/sensitive skin types. sulph. 0.5%, benzoyl peroxide 10%. 25g, A2.10; P Applya thin film twice daily after 50g, A3.49. washing. 2 Q Not recommended. ALSO QUINODERM CREAM 5 K+ hydroxyquinoline D Pregnancy, lactation. sulph. 0.5%, benzoyl peroxide 5%. 50g, A3.21. B Avoid contact with eyes, avoid UV S Acne vulgaris, acneform eruptions, exposure, history of blood dyscrasia. folliculitis. A Local irritation. B Avoid eyes, mouth and mucous membranes. SKINOREN 15% GEL Bayer Schering A Transient irritation and peeling. 2MO
2
Janssen-Cilag Antibacterial/keratolytic. Azelaic acid 15%. Topical
RETIN-A 0.05%
gel. 30g, A8.10. S Relief of mild/moderate papularpustular acne of facial area. Topical treatment of papulopustular rosacea. P Cutaneous use only. Cleanse skin before application. Apply sparingly to affected skin areas twice daily (morning and evening) and massage gently into the skin. Approximately 0.5g ( 2.5cm) of gel is sufficient for the entire facial area. Occlusive dressing or wrappings should not be used, and hands should be washed after application. Q Under 12 years, not recommended. D Propylene glycol hypersensitivity. B External use only. Avoid contact with eyes, mouth and other mucous membranes. Pregnancy. Infants must not come into contact with treated skin/breast. ROACCUTANE Roche A Burning/stinging, pruritus, erythema/skin 2NO irritation, dry skin, scaling. Vitamin A derivative. Isotretinoin 10mg, 20mg. Oval, opaque, reddish violet (10mg) or pale redSTIEMYCIN Stiefel violet and white (20mg) cap. imprinted with ROA 2 N O 10 or ROA 20 resp. 10mg-30, A17.08; 20mg-60, Antibiotic. Erythromycin 2%; alc. soln. 50ml, A68.31. A10.44. S Cystic and conglobate acne, severe acne S Acne. unresponsive to antibiotic therapy. V Apply twice daily after washing. P Initially 0.5mg/kg body-wt. daily as a single dose or in two divided doses with food for A Local irritation, dryness.
2M
Vitamin A derivative. Tretinoin 0.05%; cream. 20g, A14.78. S For the management of acne vulgaris and other keratotic conditions. P Apply once or twice daily. 6-8 weeks therapy may be needed before improvement is seen. D History of cutaneous epitheliomata or eczema, damaged skin.Pregnancy. B Avoid excessive sunlight and use of U-V lamps. Contact with eyes, mucosa and open wounds. Lactation (caution). C Keratolytics. A Erythema, irritation. Contact dermatitis (rare).
4 weeks, then adjust dosage according to response for remainder of 3-4 month course (max. 1mg/kg body-wt daily. Repeat courses are not normally recommended. See SPC. Q Not recommended. D Hepatic and renal impairment. Pregnancy, lactation. B Exclude pregnancy before starting treatment; effective contraceptive measures must be taken by women of child-bearing potential for 1 month before, during and for at least 4 weeks after therapy. (Patient information leaflets are available.) Monitor liver function and blood lipids regularly. See prescribing notes. C High dose vitamin A. A Dryness, erosion of mucosa. Monitor for keratitis with dry eyes. Alopecia. Rise in liver enzymes and serum triglycerides. Nausea, headache, drowsiness, sweating, mood changes, seizures, menstrual irregularities. Reversible haematuria and proteinuria. Occasionally, hearing loss, allergic vasculitis, thrombocytopenia. Rarely, facial hyperpigmentation, hirsutism, acne fulminans.
TETRALYSAL
Antibiotic. Tetracycline (as lymecycline) equiv. 300mg base; gelatin cap. 28, A9.63. S Acne vulgaris. P 1 daily for at least eight weeks. Q Not recommended. D Advanced renal insufficiency. Pregnancy, lactation. B Hepatic or renal insufficiency. C Antacids/iron preps., anticoagulants. A GI disturbances, diarrhoea, superinfection, photosensitivity. Crawford
2NO
Antibacterial. Clindamycin (as phosphate) 1%. Gel. 30g, A9.50. S Mild to moderate acne vulgaris. P Apply thin film once daily. Q Under 12 years, not recommended. D Lincomycin sensitivity. B Avoid contact with eyes and mucous membranes. Pregnancy. ROZEX Galderma C In vitro erythromycin, metronidazole, 2MO aminoglycosides. Nitroimidazole antibiotic. Metronidazole 0.75%; A Dry skin, erythema, irritation, acne aqu. gel. 30g, A5.49. exacerbation, pruritus. Rarely, diarrhoea or colitis (discontinue immediately). S Acne rosacea.
292
Astellas
2NO Antibiotic. Erythromycin 4%, zinc acetate 1.2% complex; alc. topical soln. 30ml with applicator, A9.60. S Acne vulgaris in adolescents, adults and the elderly. P Apply twice daily to affected area. D Hypersensitivity to ingredients. B Avoid eyes and mucous membranes. Pregnancy. Avoid use on chest whilst breast feeding. A Local irritation, transient erythemia and dryness.
15.6 WART TREATMENTS
COMPOUND W
SSL Healthcare
2K Keratolytic. Salicylic acid 17%; sln 6.5ml with applicator, A3.39. S Warts and verrucas. V Rub the hard skin from the surface and apply to wart/verruca once daily for up to 4 weeks and cover with plaster. D Moles, birth marks, genital or facial warts. B Avoid eyes and mucous membranes. Consult doctor if diabetic. Children under 6 years (only on medical advice). Flammable. Do not apply to healthy skin or broken or inflamed skin.
CUPLEX
Smith & Nephew
2
Keratolytic. Salicylic acid 11%, lactic acid 4%, copper acetate (equiv. to 1.1mg Cu++ per 100 g); gel. 5g, A3.95. S Common, juvenile, plantar and mosaic warts; corns and calluses. V Apply one or two drops to dry wart at night after soaking. Remove elastic film in morning and re-apply. Rub with pumice between applications. D Facial and anogenital warts. Galderma B Avoid healthy skin.
2NO
ZINDACLIN
ZINERYT
DUOFILM
Stiefel
2 Keratolytics. Salicylic acid 16.7%, lactic acid 16.7%; liquid. 15ml with applicator, A3.49. S Plantar and mosaic warts. V Apply daily, avoiding normal skin. Allow to dry and cover with plaster. Pare down surface of wart between applications. PRESCRIBING NOTES WARTS Warts are caused by the human papilloma virus. Plantar warts affect the hands and feet. Warts will eventually disappear on their own but treatments are available for those that are painful or unsightly. Salicyclic acid is a keratolytic and useful as a first line treatment. Formaldehyde and glutaraldehyde are both effective and work best when scale and dead tissue is removed from the wart with a file before application. Podophyllin resin has an antimitotic action and is used on its own or in combination with salicylic acid. All these preparations should be applied carefully to ensure no healthy skin is affected. References available on request.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY
WOUND
flavours), A2.07. S Acute or chronic wounds or patients with poor wound healing. GLUTAROL Dermal Q Under 6 years, caution. Under 1 year, not recommended. 2 Virucidal-anhidrotic. Glutaraldehyde 10%; soln. EPIGLU Synapse 10ml with applicator, A4.04. Tissue adhesive. Ethyl-2-cyanoacrylate 95 45mg, S Warts, particularly plantar warts. polymethylmethacrylate. Epiglu 01:1 x 3g vial, 20 V Apply twice daily (a plaster is applications, 20 pipets, 1 dosage tray, A53.00; unnecessary). Pare down hard skin. Epiglue 02: 2 x 3g vial, 40 applications, 40 pipets, D Facial and anogenital warts. 2 dosage trays, A82.00; Epiglu 04: 4 x 3g vial, 80 B Avoid healthy skin. applications, 80 pipets, 4 dosage trays, A120.00. A Stains skin during treatment. S Tissue adhesive for external use. Apply OCCLUSAL Alliance to fresh incisions and lacerations (also postoperative). For the closure of wounds after careful 2 adaptation of the wound edges, as a suture Keratolytic. Salicylic acid 26%; soln. 10ml, A4.94. substitute, and for additional suture support. S Warts. Apply two applications allowing D Do not use on contaminated ot to dry between each. Repeat daily, abrading wart inflamed tissue. before applying. B Avoid contact with eyes. D Facial and anogenital warts. B Avoid healthy skin. IRUXOL MONO Smith & Nephew D Facial and anogenital warts. B Avoid healthy skin.
SALACTOL
Dermal 2 N O
2 Keratolytics. Salicylic acid 16.7%, lactic acid 16.7%. Paint. 10ml with applicator, A4.02. S Warts, verrucae, corns and calluses. V Apply to wart once daily and, for plantar warts, cover with a plaster. Rub with pumice between applications. D Facial and anogenital warts. B Avoid healthy skin.
Clostridiopeptidase A 1.2 units/g, associated enzymes 0.24 units/g. Oint. 20g, A10.99. S Debridement of necrotic wounds and varicose ulcers, diabetic ulcers, bed sores. D Major burns. B Antiseptic solns. and soaps not to be used. C Tyrothricin, gramicidin, tetracyclines. A Local pain, burning, pruritus.
MANAGEMENT
15.7
required, max. weekly. D Arterial leg ulcers. A Rash, erythema, itching, maceration of wound edge.
15.8 TOPICAL CORTICOSTEROIDS
ALPHADERM
Alliance
2MO Moderately potent steroid/hydrating agent. Hydrocortisone 1%, urea 10%. Cream. 30g A2.88; 100g, A8.93. S Treatment of all dry ichthyotic, eczematous conditions of the skin. V Apply twice daily to dry cleansed skin. D See SPC.
BETACAP SCALP APPLICATION Dermal
2MO Potent steroid. Betamethasone (as valerate) 0.1% with coconut oil derivative 100ml, A4.79. S Steroid responsive dermatoses of the scalp. P Apply sparingly night and morning. Q Under 1 year, not recommended; over 1 year, do not use for longer than 5-7 days. D See SPC.
BETNOVATE
GSK
2MO
Potent steroid. Betamethasone (as valerate) 0.1%. Cream and oint. 30g, A1.64; 100g, A4.57. S Psoriasis, lichen simplex and planus, REGRANEX Janssen-Cilag eczema, prurigo nodularis, seborrhoeic dermatitis, SALATAC GEL Dermal ;N contact dermatitis, discoid lupus erythematosus. 2 rhPDGF. Becaplermin 100mcg/ml gel. 15g tube, Adjunct to systemic steroid therapy in generalized Keratolytics. Salicylic acid 12%, lactic acid 4%. Gel. A 488.79. erythroderma, insect bite reactions and prickly 8g (plus applicator, emery board and instructions), S Granulation and thereby healing of full- heat. A5.86. thickness, neuropathic, chronic, diabetic ulcers R V Apply sparingly 1-3 times daily. Under 3 S Warts, verrucae, corns and calluses. 5cm2. years, max. duration 3 weeks. V Apply to wart once daily. Abrade, using P Apply as thin layer to ulcerated area 2MO emery board supplied, once a week. once daily using clean application aid. Cover by ALSO BETNOVATE RD Betamethasone (as D Facial and anogenital warts. moist saline gauze dressing. Max 20 weeks. valerate) 0.025%. Cream and oint. 100g, A3.81. B Avoid healthy skin. Q Not recommended. S Maintenance treatment when control D Known neoplasm at or near appl. site, has been achieved with Betnovate. VERICAPS Ovelle infected ulcers, ulcers not of primarily neuropathic V Apply 1-3 times daily. Under 3 years, 2 origin. Pregnancy, lactation. max. duration 3 weeks. Keratolytic. Salicylic acid 10%. Paste in adhesive B Treat infection, exclude/treat 2MO felt plaster. 1 treatment pack, A4.19. osteomyelitis and peripheral arteriopathy first. ALSO BETNOVATE-C Betamethasone (as valerate) V Apply medicated centre to wart, leave Under supervision of physicians experienced in 0.1%, clioquinol 3%; cream. 30g, A2.00. in place for two days, scrape away loose debris. management of diabetic wounds. S As Betnovate when infection due to Apply fresh plaster and repeat treatment until C Topical drugs at same site. micro-organisms sensitive to anti-infective is likely. lesion disappears. A Infective skin ulcer, cellulitis, rash, V Apply sparingly 2-3 times daily. D Inflamed or broken skin. Diabetes. erythema, osteomyelitis, pain. Maintenance, apply once daily or less. A Localised pain and redness.
15.7 WOUND MANAGEMENT
ROWAROLAN
Rowa
2MO
ALSO BETNOVATE SCALP APPLICATION Betamethasone (as valerate) 0.1%. Soln. 100ml, A5.99. S Steroid-responsive dermatoses of the scalp, eg. psoriasis, seborrhoea capitis and inflammation associated with severe dandruff. V Apply sparingly morning and evening. Maintenance, apply once daily or less. Under 3 years, max. duration 3 weeks. D Rosacea, acne vulgaris, peri-oral dermatitis; peri-anal and genital pruritus; primary cutaneous viral infections; widespread plaque Zinc oxide 20%. Sterile rayon stocking ENSURE PLUS HP Abbott psoriasis, except single lesions; dermatoses in impregnated with oint. Case-4, A21.33; Case-10, 1O A53.33. children Q1 year; untreated bacterial, viral, tuberculosis or fungal infections. Pregnancy, Oral nutritional. Energy 250kcal. Protein 15.8g, fat S Aid in treatment of chronic leg ulcers. 6.6g, carbohydrate 31.8g per 200ml. Gluten- and P Apply to lower leg and cover with outer lactation. Neomycine: Otitis externa when ear drum perforated. clinically lactose-free. 1.25 kcal/ml. Nutritionally bandage. In chronic venous insufficiency apply under compression bandaging. Change stocking as B Long term therapy (avoid). Use with complete. 200ml bottle with straw attached (2
2
CUBITAN Nutricia Exudate absorbant. Koraterrit (Creta Praep.) 90%. powder. 20g, A3.60. 1O S Leg ulcers, bed sores and similar Oral nutritional. Protein 20g, arginine enriched 3g, conditions. vitamins, minerals, trace elements per 200ml. P Sprinkle powder at least 3 times daily Nutritionally balanced sip feed. (3 flavours). 1.25 on affected area. kcal/ml. Plastic bottle with straw- 200ml, A2.07. S Assist the healing of pressure sores. ZIPZOC Smith & Nephew Q Under 3 years, not recommended. 2
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
293
15.8 TOPICAL
DERMATOLOGY
CORTICOSTEROIDS
occlusive dressing. Avoid eyes. Psoriasis (caution). Possibility of hypercortisolism, adrenocortical suppression, growth suppression, especially in children. A Local skin burning and pruritus.
A Irritation/burning, hypersensitivity reactions.
Antifungal-antibacterial. Miconazole nitrate 2%, hydrocortisone 1%; cream. 30g, A2.60. S Skin conditions where inflammation and CLARELUX Pierre Fabre infection by susceptible organisms co-exist. V Apply one or three times daily. Avoid 2MO treatment for longer than 3 weeks in children Very potent steroid. Clobetasol propionate BETTAMOUSSE UCB 500mcg/g. White foam. 100g. under 3 years. D See SPC. 2NO S Steroid responsive dermatoses of the Potent steroid. Betamethasone (as valerate) 0.1%; scalp such as psoriasis, which do not respond DERMOVATE GSK satisfactorily to less active steroids. scalp application. 100g, A9.36. 2MO P Apply to affected area twice daily for S Steroid responsive dermatoses of the Potent steroid. Clobetasol propionate 0.05%; no more than 2 consecutive weeks. Max. 50g/ scalp. cream and oint. 30g, A2.97; 100g, A8.71. week. P Apply no more than a golf ball sized S Psoriasis, intractable eczemas and other Q Not recommended. amount to scalp morning and night until inflammatory dermatoses. noticeable improvement. If no improvement after D Burns, rosacea, acne vulgaris, perioral P Apply sparingly once or twice daily; for 7 days, discontinue. Maintenance, apply once daily dermatitis, perianal and genital pruritus. Primary max. four weeks, then review. infected skin lesions caused by viruses, fungi or or less frequently. Q Same as adult but review weekly. Under bacteria. Use on face. Pregnancy, lactation (unless Q Under 6 years, not recommended; over 3 years, max. duration 3 weeks. 6 years, in proportion to dose for adults. Limit use clearly necessary). 2MO B Avoid long-term therapy. Chronic for 5-7 days. ALSO DERMOVATE SCALP APPLICATION intermittent use, assess Hypothalamic-PituitaryD See SPC. Clobetasol propionate 0.05%. alcoholic soln. Adrenal (HPA) axis function periodically. B Avoid eyes, open wounds, mucous 100ml, A11.48. Secondary infection may develop. Caution: Liver membranes. Do not use with occlusive dressings. V Apply sparingly once or twice daily. impairment. Rebound relapses can follow Under 3 years, max. duration 3 weeks. CALMURID HC Galderma development of tolerance. Risk of developing generalised pustular psoriasis and local or systemic D Rosacea, acne vulgaris and peri-oral 2MO dermatoses; peri-anal and genital pruritus; primary toxicity. Cataracts may develop. Should not be Hydrating/keratolytic agents/mildly potent steroid. used with occlusive dressings (unless supervised by cutaneous viral infections; widespread plaque Urea 10%, lactic acid 5%, hydrocortisone 1%; psoriasis, except single lesions; dermatoses in a physician). Contains propylene glycol, cetyl cream. 100g, A11.35. children Q1 year; untreated bacterial, viral, alcohol and stearyl alcohol. S Eczema, dermatitis. tuberculosis or fungal infections. Extensive use in A Application site reactions. V Apply twice daily after washing. pregnancy. D See SPC. CORTOPIN HYDROCORTISONE B Long term therapy (avoid). Use with Pinewood occlusive dressing. Avoid eyes. Psoriasis (caution). CANESTEN-HC Bayer HealthCare Possibility of adrenocortical suppression, growth 2 K 2MO suppression, hypercortisolism, especially in Mildly potent steroid. Hydrocortisone 1%; cream. children. Lactation. Antifungal/mildly potent steroid. Clotrimazole 1%, A2.45. 15g, A Local hypersensitivity reactions. Striae, A hydrocortisone 1%. Cream. 30g, 3.68. S Contact dermatitis, irritant dermatitis, thinning of the skin, dilatation of superficial blood S Fungal infections accompanied by mild to moderate eczema, insect bite reactions. vessels (prolonged use). inflammation. V Apply twice daily to affected area for V Apply twice daily, thinly and evenly. DIODERM Dermal not more than 7 days. D Bacterial/viral skin diseases, vaccination D See SPC. 2MO reactions, perioral dermatitis, broken skin, acne. Large areas, long-term use, under occlusive Mildly potent steroid. Hydrocortisone 0.1%; cream. DAKTACORT Janssen-Cilag dressing. 30g, A3.16. 2 M O S Inflammatory, pruritic and allergic skin B Pregnancy, lactation (only if essential). conditions. PRESCRIBING NOTES V Apply sparingly and rub in well twice TOPICAL CORTICOSTEROIDS daily. Topical corticosteroids are effective in inflammatory dermatoses, not caused by infection, such as eczema D See SPC. and psoriasis. They act by reducing the inflammatory response but do not cure the condition, which often returns on cessation of treatment. There are guidelines to their appropriate use. Apply an appropriately potent compound to bring the condition under control, then continue treatment with a less potent preparation after control is obtained, reduce the frequency of application, and if required continue daily with the weakest treatment that will control the treatment, once healed, tail off treatment. Eczema responds well to topical corticosteriod treatment, psoriasis less so as relapse or vigorous rebound occurs on withdrawal. Topical corticosteroids are of no value in the treatment of urticria, rosacea, pruritus and acne. Extra care must be taken when treating children and certain parts of the body, face and flexures. There can be a seven fold increase in the absorption in various areas: forearm 1%, scalp 4%, forehead 7%, scrotum 36%, the groin, axillae and face are all sites of high penetrability, and these sites will develop local side effects more easily. Application to the face must be limited to mild presentations nominally hydrocorisone 0.5-1%. Preparation of an appropriate strength should be used. Reasonable amounts should be prescribed, it will take between 12.6g to cover the adult body once, an arm will take between 2-3g. Applications after bathing, in thin layers applied smoothly, without rubbing, produce the best results. Application twice a day is recommended, more than this achieves no extra gain. Creams are more suitable for moist or weeping lesions, ointments for dry and scaly lesions requiring occlusion. Lotions are useful for thin applications to a large areas including the scalp. Occlusive dressings increase absorption but also can increase the possibility of side effects. Preparations with urea and salicylic acid increase the penetration of the corticosteroid. Inclusion of antibacterials and antifungals in compound preparations may be appropriate only if there is associated infection. Local side effects, which occur with the potent and very potent compounds, include thinning of the skin, contact dermatitis, striae and telangiectasia, cushingoid changes and adrenal suppression. References available on request.
294
DIPROSALIC
Schering-Plough
2MO Potent steroid/keratolytic. Betamethasone dipropionate 0.05%, salicylic acid 3%. Oint. 30g, A3.72; 100g, A10.84. S Hyperkeratotic and dry corticosteroidresponsive dermatoses. V Apply a thin film to affected area once or twice daily.
2MO ALSO DIPROSALIC SCALP APPLICATION Betamethasone dipropionate 0.05%, salicylic acid 2%. Alcoholic lotion. 100ml, A12.04. V Apply a few drops to scalp twice daily and massage in. D See SPC.
DIPROSONE
Schering-Plough
2MO Potent steroid. Betamethasone dipropionate 0.05%. Cream and oint. 30g, A2.99; 100g, A8.52. S Steroid responsive dermatoses of the skin.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DERMATOLOGY V Apply sparingly once or twice daily.
2MO ALSO DIPROSONE LOTION Betamethasone dipropionate 0.05%. Acoholic soln. 30ml, A3.79; 100ml, A10.84. S Serious steroid responsive dermatoses of the scalp. V Apply a few drops twice daily. D See SPC.
TOPICAL EURAX-HYDROCORTISONE 2MO
CORTICOSTEROIDS
15.8
1%. 15g, A1.75. S Corticosteroid-sensitive superficial
Novartis Consumer dermatoses.
Antipruritic/mildly potent steroid. Crotamiton 10%, hydrocortisone 0.25%. Cream. 30g, A2.67. S Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema. V Apply two or three times daily. Use with ELOCON Schering-Plough caution in infants and for not more than 7 days. D Acute exudative dermatoses, skin 2NO infections. See SPC. Potent steroid. Mometasone furoate 0.1%. Cream, oint. and scalp lotion. Cream and oint.-30g, A5.78; FUCIBET LEO Pharma Cream and oint.-100mg, A15.00; Scalp lotion2NO 30ml, A5.78. Potent steroid/antibacterial. Betamethasone S Inflammatory and pruritic valerate 0.1% and fusidic acid 2%. Fucibet Cream: manifestations of psoriasis (excluding widespread Homogenous cream; Fucibet Lipid: Viscous oil-inplaque psoriasis) and atopic dermatitis. Scalp water emulsion cream (equiv. ointment). 15g, psoriasis and seborrhoeic dermatitis. A4.51; 30g, A7.57. P Apply once daily to affected area. Q Under 2 years, not recommended; over S Inflammatory dermatoses where bacterial infection is present or suspected. 2 years, same as adult. V Apply twice daily. Usual max. duration, D See SPC. 2 weeks. ETRIVEX Galderma D Skin infections primarily caused by bacteria, fungi or virus, skin manifestations in 2O relation to tuberculosis or syphilis, acne vulgaris, Very potent steroid. Clobetasol propionate perioral dermatitis and rosacea. Pregnancy, 500mcg/g. Shampoo, 125 ml. A16.08. lactation (unless clearly necessary). S Topical treatment of moderate scalp B Prolonged use, large areas. Avoid: psoriasis in adults. Atrophic skin, cutaneous ulcers, acne vulgaris, P Apply approx. 7.5 ml (half a tablespoon) fragility of skin veins, perianal/genital pruritus. once daily. Max treatment duration: 4 weeks. Avoid open wounds and mucous membranes. When improvement observed, space out A Appl. site irritation, allergic reaction. applications or replace by alternative treatment if needed. If no improvement in 4 weeks, reassess FUCIDIN H LEO Pharma diagnosis. Repeated courses may be used to 2NO control exacerbations. Antibacterial/mildly potent steroid. Fusidic acid Q Under 2 years, contra-indicated. Under 2%, hydrocortisone acetate 1%. Cream. 15g, 18 years, not recommended. A3.85; 30g, A6.65. D Skin areas affected by bacterial, viral, S Inflammatory dermatoses where fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by bacterial infection is present or suspected. lues). Do not apply to the eye (risk of glaucoma) V Apply one to four times daily or as or to ulcerous wounds. Pregnancy, lactation required. Under 3 years, max. duration 3 weeks. (unless clearly necessary). D Infections due to non-sensitive B May occur: Post treatment rebound organisms. Pregnancy. relapses, tolerance (tachyphylaxis) and local or B Prolonged use. Lactation. systemic toxicity; use with caution. Intensive and prolonged use: Evaluate regularly for HPA axis HC45 HYDROCORTISONE suppression signs; generalised pustular psoriasis Reckitt Benckiser may occur. Suspect hypersensitivity in case of 2 resistance to treatment. Abrupt discontinuation Mildly potent steroid. Hydrocortisone acetate 1%; can lead to acute adrenal insufficiency, especially A in children. If use required below 18 years, review cream. 15g, 2.63. S Mild to moderate eczema, irritant treatment weekly. Do not treat skin areas other contact dermatitis, allergic contact dermatitis, than scalp. If product enters the eye, rinse with insect bite reactions. copious amounts of water. V Over 10 years, use sparingly on small A Skin discomfort, acne/folliculitis, eye areas, once or twice daily, for max. 7 days; under stinging/burning. Very rarely: Hypercortisolism 10 years, under medical supervision. (Cushing syndrome) or HPA axis suppression (prolonged use, treatment of extensive areas, use D See SPC. of large amounts).
V Apply one to four times daily. Under 12 yrs: Apply sparingly over small area once or twice daily for max. 1 week (under medical supervision). D Untreated bacterial, viral, tuberculous or fungal infections. Acne rosacea. Perioral dermatoses. Plaque psoriasis. Use on eye, face, anogenital region, broken/infected skin, cold sores, acne and athletes foot. B Use with occlusive dressings. Continuous application without interruption may lead to local atrophy, striae, superficial vascular dilation, adrenocortical suppression or growth retardation. Prolonged use for acne vulgaris. Use in psoriasis may lead to generalisation, excessive systemic absorption and rebound relapse on cessation. Local skin reaction. A Striae, hypersensitivity.
LOCOID
Astellas
2MO Medium potent steroid. Hydrocortisone 17butyrate 0.1%; cream and oint. 30g, A2.58; 100 g, A7.89. S Corticosteroid sensitive dermatoses. V Apply two to three times daily.
2MO ALSO LOCOID C Hydrocortisone 17-butyrate 0.1%, chlorquinaldol 3%; cream and oint. 30g, A3.37. S As for Locoid when infection is present or suspected. V Apply two to three times daily.
2MO ALSO LOCOID LIPOCREAM Hydrocortisone 17butyrate 0.1% cream base containing 70% oil. 30g, A3.12; 100g, A9.60. S Corticosteroid sensitive dermatoses. V Apply twice daily.
2MO ALSO LOCOID SCALP LOTION Hydrocortisone 17butyrate 0.1%; alcoholic soln. 100ml, A11.14. S Corticosteroid sensitive dermatoses. V Apply two to three times daily. D See SPC.
LOTRIDERM
Teva
2MO
Potent steroid/antifungal. Betamethasone (dipropionate) 0.064%, clotrimazole 1%. Cream. 30g, A9.03. S Short term treatment of cutaneous fungal infections. V Apply morning and evening for 2 weeks in tinea cruris, tinea corporis and candidiasis, and for 4 weeks in tinea pedis; under 12 years, not recommended. D Facial rosacea, acne vulgaris, perioral dermatitis, napkin eruptions, bacterial or viral infections. B Continued use on large areas, damaged in flexures, occlusive dressing. Pregnancy, HYDROCORTISYL CREAM sanofi- skin, lactation. aventis A Local mild burning, irritation. EUMOVATE GSK 2OY Hypersensitivity reactions. 2MO Mildly potent steroid. Hydrocortisone 1%. 15g, Moderately potent steroid. Clobetasone butyrate MODRASONE Teva A1.75. 0.05%; cream and oint. 30g, A2.03. 2MO S Mild eczema, seborrhoeic dermatitis and S Corticosteroid-sensitive superficial dermatoses (Prescription). Contact dermatitis, other steroid-responsive disorders. Maintenance Moderately potent steroid. Alclometasone irritant dermatitis and insect bite reactions therapy between courses of more potent topical dipropionate 0.05%. Cream and oint. 15g, A1.97; (Pharmacy). steroids in the more resistant dermatoses. 50g, A5.59. 2MO S Corticosteroid responsive dermatoses. V Apply up to four times daily. ALSO HYDROCORTISYL OINTMENT Hydrocortisone V Apply two or three times daily. D See SPC. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
295
15.9 MISCELLANEOUS
DERMATOLOGY
D See SPC.
TRAVOCORT 2MO
Antifungal/potent steroid. Isoconazole nitrate 1%, difluocortolone valerate 0.1%; cream. 15g, A2.97. S Fungal and Gram-positive bacterial infections accompanied by inflammation. V Massage into affected area morning and evening. D See SPC.
VIOFORM HYDROCORTISONE Novartis Consumer
2MO Antibiotic-antifungal/mildly potent steroid. Clioquinol 3%, hydrocortisone 1%. Cream and oint. 30g, A1.83. S Eczema, dermatosis, ano-genital pruritus, infected insect bite reactions. V Apply sparingly 1-3 times daily. Not for use in children under 2 years. D See SPC.
15.9 MISCELLANEOUS
ANHYDROL FORTE
Dermal
2 Antiperspirant. Alum. (chlor.) 20%. soln. in roll-on bottle. 60ml, A6.70. S Hyperhidrosis of the axillae, hands and feet only. V Apply to affected areas when necessary at night, wash off in the morning. D Inflamed and broken skin. B Ensure that area is dry and not shaved 12 hrs. before or after use. Avoid contact with clothes and jewellery.
DRICLOR
Stiefel
2K Antiperspirant. Alum. Cl hexahydrate 20%; soln. 20ml, A3.95. S Hyperhidrosis, particularly of the axillae, hands and feet. V Apply to affected areas where necessary at night, wash off in the morning. D Inflammed and broken skin. B Avoid contact with eyes. Ensure area is dry and not shaved 12 hrs. before or after use.
ROGAINE
contraceptive effectiveness, all tablets should be Vasodilator. Minoxidil 2%, 5%; proof liquid. 2%60ml, A17.78; 5%-60ml, A20.95; 3 x 60ml, A45.81. taken at approximately the same time each day. D See Drug Prescribing Notes. androgenetica. Bayer Schering P 18-65 years, 1ml applied to the affected DIANETTE area of the scalp twice daily. 2MO D Pregnancy. Oestrogen/progestogen. Ethinyloestradiol 35mcg, B Avoid eyes, mucous membranes, cyproterone acetate 2mg. Beige sug-ctd biconvex sensitive or damaged skin. tab. 21, A5.58. A Local irritation, allergic reactions. S Contraceptive for females with severe acne vulgaris. VANIQA Shire P 1 daily. First course begins on first day 2NO of menses, with seven day interval between 21 Ornithine decarboxylase inhibitor. Eflornithine (as day courses. monohydrate Cl) 11.5% w/w. Cream. 30g, A29.78. D See SPC. S Facial hirsutism in women. P Apply twice daily, at least eight hours ESTELLE Clonmel apart. Rub in thoroughly. Do not cleanse within 2MO four hours of application. Max.: 30g per month. Oestrogen/progestogen. Ethinylestradiol 30mcg, Continued treatment necessary to maintain gestodene 75mcg. White, round, biconvex sugarbeneficial effects. ctd tabs. 21, A2.14. Q Under 12 years, not recommended. S Oral contraception. 1 daily for 21 days, D Pregnancy, lactation (no data). starting on first day of menstruation, then 7 B Consider underlying cause (e.g. PCOS, tablet-free days. androgen secreting neoplasm, certain medications). Cutaneous use on areas of face and D See Drug Prescribing Notes. B Contains lactose and sucrose. under chin only. Avoid contact with eyes or mucous membranes (e.g. nose or mouth). Severe LEONORE Rowex renal impairment. A Acne, pseudofolliculitis barbae, alopecia, 2 M O rash, folliculitis, pruritis, erythema. Dry, irritated, Oestrogen/progestogen. Levonorgestrel 100mcg, stinging, burning, or tingling skin. ethinylestradiol 20mcg. White round biconvex tabs. 3 x 21, A9.00 (1 month 21, A3.00). 16.1 COMBINED ORAL CONTRACEPTIVES coated S Oral contraception. P One daily for 21 consecutive days BREVINOR Pharmacia starting on the first day of menstruation, followed 2MO by 7 tablet-free days. Oestrogen/progestogen. Ethinyloestradiol 35mcg, D See Drug Prescribing Notes. norethisterone 0.5mg. Blue round, flat beveledB Contains lactose. edge tab. marked SEARLE on one side and BX on the other. 21, 67c. LOGYNON Bayer Schering S Oral contraceptive. 1 daily for 21 days 2MO starting on first day of menstruation, then 7 Oestrogen/progestogen. Ethinyloestradiol 30mcg, tablet-free days. levonorgestrel 50mcg (6 brown tabs.); D See Drug Prescribing Notes. ethinyloestradiol 40mcg, levonorgestrel 75mcg (5 CILEST Janssen-Cilag white tabs.); ethinyloestradiol 30mcg, levonorgestrel 125mcg (10 ochre tabs.); sug-ctd 2MO tabs. 21, A3.71. Progestogen/oestrogen. Norgestimate 0.25mg, S Oral contraception. ethinyloestradiol 35mcg. dark blue tab. marked C P 1 daily for 21 days starting on 1st day 250 each side. 21, A2.17. of menstruation, then 7 tablet-free days. S Oral contraception. 1 daily for 21 days starting on the first day of the menstruation, then D See Drug Prescribing Notes.
Bayer Schering S Male and female alopecia
McNeil Healthcare
2
7 tablet-free days. To obtain maximal
MARVIOL
PRESCRIBING NOTES MISCELLANEOUS DERMATOLOGICALS Sunscreen agents are of two types, chemical agents containing chromophore groups, which work by absorbing UV light, and physical agents that are opaque and reflect the UV radiation. Examples of chemical agents include aminobenzoates, benzophenones and camphor derivatives; physical agents include titanium and zinc oxide. The efficacy of sunscreens is expressed as the SPF. This is the ratio of the time required to produce minimal perceptible erythema with and without the sunscreen, the range is from 2 to 15. Aluminium chloride is used in a 20% alcoholic solution as an antiperspirant in the treatment of hyperhidrosis, though its mode of action is not fully understood. Minoxidil can be used topically to treat alopecia androgenetica and alopecia areata, its mode of action is not clear but it is believed that it may act by direct stimulation of the hair follicle epithelium. Salicylic acid has keratolytic properties and can be applied topically in the form of a paint or a collodion basis to destroy warts or corns. Tretinoin appears to stimulate the epithelium to produce horny cells at a faster rate and to reduce their cohesion, and is used in some disorders of keratinisation. References available on request.
296
Schering-Plough
2MO Oestrogen/progestogen. Desogestrel 150mcg, ethinyloestradiol 30mcg. White tab. marked TR over 5, ORGANON and *. 3 x 21, A8.27. S Oral contraception. 1 daily for 21 days starting on 1st or 5th day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
MERCILON
Schering-Plough
2MO Oestrogen/progestogen. Ethinyloestradiol 20 mcg, desogestrel 150 mcg; white tab. coded TR over 4 on one side and ORGANON on reverse. 3 x 21, A9.92. S Oral contraception. 1 daily for 21 days starting on 1st or 5th day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CONTRACEPTION MICROLITE
PROGESTOGEN-ONLY CONTRACEPTIVES 16.2 Berlipharm
2MO Oestrogen/progestogen. Ethinyloestradiol 20mcg, levonorgestrel 100mcg. Pink sug-ctd tab. 3 x 21, A11.25 (1 month 21, A3.75). S Oral contraception. 1 daily for 21 days, starting on 1st day of menstruation, then 7 tabletfree days. D See Drug Prescribing Notes.
drospirenone 3mg. Light yellow film-ctd tab. marked DO in a hexagon one side. 3 x 21, A16.89 (1 month 21, A5.63). S Oral Contraception. 1 daily for 21 days starting on first day of menstruation, then 7 tablet-free days. Bayer Schering D See Drug Prescribing Notes.
S Oral contraception. P 1 daily for 21 days starting on first day of menstruation, then 7 tab.-free days. D See Drug Prescribing Notes. B Contains lactose and sucrose.
QLAIRA 2MO
Oestrogen/progestogen. Estradiol valerate 3mg (2 dark yellow tabs marked DD), estradiol valerate 2mg and dienogest 2mg (5 medium red tabs MINULET Wyeth marked DJ), estradiol valerate 2mg and dienogest 2MO 3mg (17 light yellow tabs marked DH), estradiol Oestrogen/progestogen. Ethinyloestradiol 30mcg, valerate 1mg (2 dark red tabs marked DN). 2 gestodene 75mcg; white sug-ctd tab. 3 x 21, white tabs marked DT without active substance. 1 A6.54. wallet (28 tabs), A8.49. S Oral contraception. 1 daily for 21 days, S Oral contraception. starting on first day of menstruation, then 7 P Start on day 1 of natural cycle. Take tablet-free days. tabs in directed order every day for 28 days at D See Drug Prescribing Notes. about same time with liquid. Start subsequent pack day after last tab. of previous wallet. OVRANETTE Wyeth D See Drug Prescribing Notes.
2MO Oestrogen/progestogen. Ethinyloestradiol 30mcg, levonorgestrel 150mcg. Round white sugar-ctd tab. 21, A0.71.
YASMIN
Bayer Schering
2MO Oestrogen/progestogen. Ethinyloestradiol 30mcg
Drug Prescribing Notes ● COMBINED ESTROGEN/PROGESTOGEN ORAL CONTRACEPTIVES Contraindications Liver disease with abnormal liver function, jaundice or persistent pruritus during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, porphyria ● Active viral hepatitis ● Severe cirrhosis of the live ● Existing or previous arterial or venous thrombotic or embolic processes or conditions which predispose to them. Multiple risk factors for arterial cardiovascular disease (e.g. older age, smoking, diabetes, hypertension) ● Sickle-cell anaemia ● Current or previous known or suspected oestrogen-dependent neoplasia ● Severe diabetes mellitus with vascular changes or > 20 year duration ● Lipid metabolism disorders Pemphigoid gestationis ● Manifestation or deterioration of otosclerosis during pregnancy ● Undiagnosed vaginal bleeding ● Cholelithiasis ● Systemic lupus erythematosus (SLE) or a history of ● Migraine with focal aura, or without focal aura in patients ≥35 years ● Severe hypertension ● Thrombogenic mutations. Special Precautions Patients with the following conditions require strict medical supervision: Diabetes mellitus, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, tetany, sydenham's chorea, renal dysfunction, family history of breast cancer or past history of breast nodules, fibrocystic disease of the breast, asthma, history of clinical depression, uterine myoma, migraine, endometriosis. Conditions implicated in an increased risk of developing venous thromboembolic complications, e.g. severe varicose veins or prolonged immobilisation or major surgery. Disorders of coagulation. Presence of any risk factor for arterial disease, e.g. smoking, hyperlipidemia, hypertension or obesity. Other conditions associated with an increased risk of circulatory disease, e.g. latent / overt cardiac failure, renal dysfunction or history of these conditions. History of cholelithiasis. Pregnancy: Oral Contraceptives are not indicated during pregnancy. Withdraw immediately if pregnancy occurs during use. An increased risk of congenital abnormalities, including heart defects and limb defects, has been reported following the use of sex hormones including oral contraceptives in pregnancy. Lactation: Oral contraceptives are not recommended. May lead to a reduction in the volume of milk and to a change in its composition. Minute amounts of the active substances are excreted with the milk. Reasons for Immediate Discontinuation Thrombophlebitis or thromboembolic events. Feeling of pain and tightness in the chest. Occurrence for the first time, or exacerbation of migrainous headaches or an increased frequency of unusually severe headaches. Sudden disturbances of vision or hearing. Six weeks before elective surgery and during prolonged immobilisation e.g. after accidents, surgery. Onset of jaundice, hepatitis, epilepsy, itching of the whole body. Significant rise in BP. Onset of severe depression. Severe upper abdominal pain or liver enlargement. Drug Interactions Not recommended: Hepatic enzyme inducers such as barbiturates, primidone, hydantoins, phenylbutazone, rifampicin, carbamazepine and griseofulvin. Ampicillin and other antibiotics. Additional, non-hormonal contraceptive precautions should be taken during the time of concurrent medication and for 7 days afterwards. If these 7 days overrun the end of a pack, the next pack should be started without a break. With rifampicin, additional contraceptive precautions should be continued for 4 weeks after treatment stops, even if only a short course was administered. St. John's Wort should not be taken concomitantly. Its effect may persist for at least 2 weeks after cessation of treatment. Caution: Oral antidiabetics or insulin can change as a result of the effect on glucose tolerance. May interfere with results of certain laboratory tests including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of carrier proteins and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, of coagulation and fibrinolysis. Side-Effects Reproductive system and breast disorders, GI disorders, headache, migraine, changes in body weight, oedema, mood changes, depression, acne, rash. Revised November 2009
YASMINELLE
Bayer Schering
2MO Oestrogen/progestogen. Ethinylestradiol 0.020mg (as betadex clathrate), drospirenone 3mg. Light pink, round film-ctd tab. with convex faces, embossed DS in a regular hexagon. 3 x 21, A19.50. (1 month, 21 A6.50). S Oral Contraception. 1 daily for 21 days starting on first day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
YAZ
Bayer Schering
2MO Oestrogen/progestogen. Ethinylestradiol (as betadex clathrate) 0.020mg, drospirenone 3mg. 24 light pink film-ctd tabs and 4 white placebo (inactive) film-ctd tabs. 28, A7.96. S Oral contraception. P One tab. daily for 28 consecutive days in the order shown on blister pack. D See Drug Prescribing Notes.
16.2 PROGESTOGEN-ONLY CONTRACEPTIVES
CERAZETTE
Schering-Plough
2MO Progestogen. Desogestrel 75mg. White, round, biconvex film-ctd tab. with one side coded KV above 2 and Organon on reverse. 28, A5.90. S Contraception. P 1 every day at about same time with 1st tab. taken on 1st day of menstrual bleeding. Start new blister directly the day after previous one. D Pregnancy, active venous thromboembolic disorder, presence/ history of severe hepatic disease as long as liver function values not normal, sex-steroid sensitive malignancies, undiagnosed vaginal bleeding. B Benefit/risk assessment required if presence/ appearance/ aggravation of: Breast cancer, liver cancer, disturbances of liver function. Caution: History of thrombo-embolic disorders, diabetes. Discontinue if: Thrombosis, long-term immobilisation due to surgery or illness, sustained hypertension. Avoid sun/UV if tendency to chloasma. Contains lactose. C Microsomal enzyme-inducing drugs (see Drug Prescribing Notes), use a barrier method during and for 28 days after admin. Medical charcoal. A Bleeding irregularity, acne, mood changes, breast pain, nausea, weight increase, headache, libido decrease.
DEPO-PROVERA
Pharmacia
2NO Progestogen. Medroxyprogesterone acetate 150mg/ml. Susp. for inj. Single dose pre-filled syringe. 1 x 1ml, A5.72. S Contraception incl. short-term contraception in case of: Protection until vasectomy in partner, women awaiting sterilisation, rubella immunisation during period of activity of virus.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
297
16.3 LONG-TERM
CONTRACEPTION
CONTRACEPTIVES
P 150mg every 3 months by IM inj. in gluteal muscle. Initial inj. during 1st 5 days after onset of menstrual period; or within 5 days postpartum if not breast-feeding or after 6 weeks if breast-feeding. Q Not indicated before menarche. D Thrombo-embolic disorders. Breast or genital cancer (known or suspected to be oestrogen dependent). Impaired liver function, active liver disease. Undiagnosed abnormal vaginal bleeding. Pregnancy. B Diabetes, depression, cardiovascular or renal disease, asthma, epilepsy. Associated with loss of BMD. Use long-term (q 2 yrs) only if other birth control methods unsuitable. Small increase in breast cancer risk, especially in older women. Potential for delay in return to full fertility following use. Sudden loss of vision, proptosis, diplopia, migraine, jaundice; do not re-admin. pending examination. C Aminoglutethimide. A Amenorrhoea, oligomenorrhoea, dysmenorrhoea, back pain, fluid retention.
veins, tetany, Syndenham’s chorea, breast cancer (or history of). Asthma. Reassess therapy after age of 35 years. See SPC. C Rifampicin or other antibiotics, antiepileptics, barbiturates, sedatives, steroids, TCAs, anticoagulants, corticosteroids. A Headaches, GI disturbances, breast tenderness, weight changes, fluid retention, depressed mood, candidiasis, rash, urticaria, erythema nodosum, erythema multiform, alopecia, irregular menstrual pattern.
MIRENA
Bayer Schering
2NO
IUS. Levonorgestrel 52mg. T-shaped intrauterine system. 1, A107.88. S Contraception. P To be inserted into the uterine cavity within 7 days of the onset of menstruation. Replace after 5 years. Delay post-partum use until 6 weeks after delivery. D Pregnancy, pelvic inflammatory disease, postpartum endometritis, infected miscarriage 16.3 LONG-TERM CONTRACEPTIVES (past 3 months), cervicitis, cervical dysplasia, uterine or cervical malignancy, undiagnosed IMPLANON Schering-Plough genital bleeding, uterine anomaly, genital infection, acute liver tumour, severe hepatic 2NO disease, progestogen-dependent tumours. Progestogen. Etonogestrel 68mg per implant 1, B Severe arterial disease, migraine, A120.47. exceptionally severe headache, jaundice, marked S Contraception. P 1 implant inserted subdermally; see SPC. increase of BP, hormone dependent neoplasia incl. D Active venous thromboembolic disorder, breast cancer, history of thromboembolism, may affect glucose tolerance. Lactation. progestagen-dependent tumours, presence or C Caution: Liver enzyme inducing drugs. history of severe hepatic disease as long as liver A Weight gain, oedema, headache, lower function values have not returned to normal. abdominal pain, back pain, acne, vaginal NORIDAY Pharmacia Known or suspected pregnancy, undiagnosed discharge, cervicitis, dysmenorrhea, mastalgia, vaginal bleeding. 2MO breast tension, depression, mood changes, nausea, B Hypertension, presence or history of Progestogen. Norethisterone 350mcg. White tab. expulsion. thromboembolic disorders. Hormone dependent marked SEARLE and NY. 28, A3.14. S Oral contraception. Starting on first day carcinoma. Liver dysfunction, glucose tolerance. NUVARING Schering-Plough of menstruation, 1 at the same time daily without Women with tendency to chloasma should avoid exposure to sun or UV. Ectopic pregnancy. 2NO any break in medication. Changes in vaginal bleeding pattern. Examine BP, Oestrogen/progestogen device. Each ring: 11.7mg D Confirmed or suspected pregnancy. pelvic organs and breasts before and regularly etonogestrel, 2.7mg ethinylestradiol (releasing Acute or chronic liver disease, jaundice, pruritus, during treatment. 120mcg etonogestrel, 15mcg ethinylestradiol per Dubin-Johnson syndrome, Rotor syndrome. C Hydantoins, barbiturates, primidone, day). Flexible transparent, colourless vaginal ring. Thromboembolic disorders, steroid dependent carbamazepine or rifampicin, oxcarbazepine, Diameter 54mm, cross sectional diameter, 4mm. 1 neoplasia. Disorders of lipid metabolism, rifabutin, troglitazone, griseofulvin. Ring, A8.00; 3 Rings, A24.00. undiagnosed vaginal bleeding. A Acne, headache, increase in body S Contraception. B Pain and tightness in chest, migraine weight, breast tenderness and pain, alopecia, P Each ring should be used continuously headaches, vision/hearing disturbances. depressive moods, emotional lability, changes in for 21 days followed by removal for 7 days. Discontinue 6 weeks before elective surgery. libido, abdominal pain, dysmenorrhoea. D Venous/arterial thrombosis, diabetes Epileptic seizures, elevated BP, onset of severe with vascular involvement, severe hepatic disease, depression. Caution: Diabetes mellitus, varicose liver tumors, steroid influenced genital organ/ breast malignancies, undiagnosed vaginal PRESCRIBING NOTES bleeding. Pregnancy. PROGESTERONE-ONLY ORAL CONTRACEPTIVES B Circulatory disorders, migraine, Progesterone-only Pills (POP). Oral progesterone only contraceptives can be used as an alternative in hormone-dependent tumours, those women where estrogens are contra-indicated i.e. patients with family history of venous thrombosis. hypertriglyceridemia, hypertension, Crohn’s They are suitable for older women, smokers, hypertensives, those with diabetes mellitus and those who disease, UC, vaginitis. Prolapse of uterine cervix, suffer from migraine. Some women, experience severe headaches or high blood pressure from the cystocele/rectocele, severe/chronic constipation. oestrogen in the combined pill and must take the progesterone-only pill. Progesterone-only pills must be C Microsomal enzyme inducers (phenytoin, phenobarbital, primidone, taken at precisely the same time each day to maintain top effectiveness. If a woman deviates from her pill carbamazepine, rifampicin, possibly oxcarbazepine, schedule for even three hours, she must take the missed pill immediately and then resume the normal topiramate, flebamate, ritonavir, griseofulvin, St schedule; she must also use back-up contraception for the next seven days. John’s wort). Penicillins, tetracyclines. If changing from a combined preparation, commence pill taking immediately after the completion of the A Acne, headache/migraine, depression, previous combined pack, omit any inactive pills if present (ED brands). Following childbirth, administration mood swings, decreased libido, abdominal pain, can commence 3 weeks postpartum, and there is no effect on lactation. nausea, weight gain, breast pain, device related Progesterone-only pill users will experience lighter periods than those taking combination pills; some may problems, dysmenorrhoea, leukorrhoea, vaginal not have periods at all. Spotting and bleeding between periods (break-through bleeding) however are side discomfort, vaginitis. effects of progesterone. This hormone may also produce fatigue, decreased sex drive, acne, and depression. Effectiveness is not reduced by broad-spectrum antibiotics but is affected by enzyme inducing drugs. The Family Planning Association recommends that additional precautions should be taken whist taking such drugs and for seven days following. Rifampicin and rifabutin are so potent these precautions should be continued for at least 4 weeks after cessation of treatment. There is no need to withdraw a POP before surgery. Vomiting within three hours of taking a pill or severe diarrhoea should be considered as a potential threat to contraceptive cover, consequently additional precautions should be used during, and until seven days after recovery. Use of the progesterone-only pill leads to a small increase in risk of breast cancer, The most important risk factor appears to be the age at which the POP is stopped and not the duration of use. The risk decreases after cessation, and there is considered to be no excess risk after 10 years. The Committee on Safety of Medicines (CSM) advises the small increase in the risk of breast cancer should be weighed against the benefits. References available on request.
298
16.4 EMERGENCY CONTRACEPTION
LEVONELLE
Berlipharm
2NO Progestogen. Levonorgestrel 1500mcg. Round white tab. marked G00. 1, A6.32. S Emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. P 1 taken as soon as possible (preferably within 12 hours and no later than 72 hours) after unprotected intercourse. If vomiting occurs within 3 hours of taking tab., take another immediately. Q Under 16 years, not recommended (very
2
5
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c
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b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CONTRACEPTION
TRANSDERMAL CONTRACEPTIVES 16.5
bleeding. Pregnancy, lactation. B Thromboembolic and other vascular disorders. Increased risk of venous thromboembolism (VTE). Caution: Smoking, hypertension, obesity, increasing age, family history. Monitor renal and liver function. Depression, epilepsy, Crohn’s disease, UC, chloasma may worsen. Irregular blood loss, esp. initial months of use. Amenorrhoea or oligomenorrhoea may occur after discontinuing. C Certain antibiotics (e.g. ampicillin, tetracycline), hepatic enzyme inducers (rifampicin, hydantoins, barbiturates, primidone, carbamazepine, rifampicin, bosentan, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, modafinil, phenyl butazone, St John’s NORLEVO Ferring Wort), lamotrigine, ciclosporin. Take additional non-hormonal contraceptive during concurrent 2NO Progestogen. Levonorgestrel 1.5mg. White, round medication and for 7 days after (up to 28 days after for hepatic enzyme inducers). biconvex tab. marked NL 1.5. 1, A6.22. A Dizziness, migraine, GI disturbances, S Emergency contraception within 72 hours of unprotected sexual intercourse or failure weight increase, myalgia, depression, emotional lability, reproductive disorders, sinusitis, upper RTI, of a contraceptive method. acne, pruritis, rash, UTI, +ve cervical smear test, P 1 tab. as soon as possible, preferably within 12 hours after unprotected intercourse and breast fibroadenosis. Q72 hours. May be taken anytime during 17.1 DYSMENORRHOEA menstrual cycle. If vomiting occurs within 3 hours of taking tab., take another tab. immediately. ADVIL LIQUIGELS Wyeth Healthcare Q Not applicable. 2K B Emergency contraception is an NSAID. Ibuprofen 200mg. Green translucent, oval occasional method. If unprotected intercourse soft gelatin cap. marked Advil one side in white q72 hours earlier in same menstrual cycle, ink. 20, A3.20. conception may have occurred. If no period S Mild to moderate pain (rheumatic/ occurs, exclude pregnancy. If pregnancy occurs muscular pain, backache, headache, dental pain, exclude ectopic pregnancy. Severe hepatic dysmenorrhoea), feverishness, cold and flu dysfunction, history of ectopic pregnancy; not symptoms. recommended. Severe malabsorption syndromes P 1-2 caps. every 4-6 hours. Max. 6 in 24 (e.g. Crohn’s disease) might impair efficacy. Thromboembolic events may occur (to be hours. considered in case of thromboembolic risk factors). Q Under 12 years, not recommended. Repeated admin. not advisable, consider long-term D Aspirin/NSAID induced allergies. Peptic methods of contraception. Contains lactose. ulcer, other GI disorders. Pregnancy (1st and 3rd Pregnancy, lactation. trimester). C Liver enzyme inducers e.g. B Asthma, cardiac/renal/hepatic anticonvulsants (phenobarbital, phenytoin, insufficiency. Elderly. primidone, carbamazepine), rifabutin, rifampicin, C Other analgesics. Caution: Oralgriseofulvin, ritonavir, St. John’s wort. anticoagulants, thiazide diuretics. A Nausea, low abdominal pain, fatigue, A GI disturbances. Rash, pruritus. Easy headache, dizziness, breast tenderness, vomiting, bruising or bleeding. Abnormal liver function heavy menses, diarrhoea, bleeding, delay of tests. menses. limited data). D Pregnancy. B Repeated admin. within menstrual cycle not advisable. If pregnancy occurs after treatment, evaluate for ectopic pregnancy. History of ectopic pregnancy, severe hepatic dysfunction; not recommended. Severe malabsorption syndrome e.g. Crohn’s disease. Lactation. Contains lactose. C Liver enzyme inducers e.g. barbiturates (incl. primidone), phenytoin, carbamazepine, St. John’s Wort, rifampicin, ritonavir, rifabutin, griseofulvin. May increase ciclosporin toxicity. A Fatigue, headache, dizziness, breast tenderness, GI disorders, bleeding pattern disturbances.
16.5 TRANSDERMAL CONTRACEPTIVES
EVRA
Janssen-Cilag
2NO Oestrogen/progestogen. Each patch: norelgestromin 6mg, ethinylestradiol 600mcg (releasing 203mcg norelgestromin and 33.9mcg ethinylestradiol per day). Thin, matrix-type transdermal patch consisting of 3 layers. 3 patches (1 month), A10.90; 9 patches (3 months), A29.78. S Female contraception. P 1 patch weekly for 3 consecutive weeks, starting 1st day of menstruation, followed by 1 patch-free week. Q Not recommended. D Presence or history of or hereditary predisposition for venous/arterial thrombosis. Prodromi of a thrombosis. Multiple risk factor(s) for arterial thrombosis. Migraine with focal aura. Carcinoma of the breast or endometrium or other estrogen-dependent neoplasia Hepatocellular disease. Hepatic adenomas/ carcinomas. Undiagnosed abnormal genital
BRUFEN RETARD
fluid. In severe or acute conditions, max. 3 daily in two divided doses. Q Not applicable.
2MO ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta sug-ctd tab. marked BRUFEN 400, magenta oval film-ctd tab. marked BRUFEN 600. 400mg-250, A6.87; 600mg-100, A4.37. P 1200-1800mg daily in three divided doses. Max. 2400mg daily. Q Not applicable. D Active peptic ulcer. B Aspirin/anti-inflammatory induced allergy. Asthma. Pregnancy. C Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, cyclosporin, other NSAIDs, corticosteroids, anticoagulants, anti-platelet agents, SSRIs, quinolone antibiotics, probenacid, oral hypoglycaemics, Ginkgo biloba extracts. A Dyspepsia, GI bleeding, rash, rarely thrombocytopenia.
DUPHASTON
Solvay
2NO Progestogen. Dydrogesterone 10mg. White scored tab. marked S and 155. 42, A8.16. S Dysmenorrhoea. P 1 twice daily from day 5 to day 25 of the cycle. D Active DVT, thromboembolic disorders, breast or genital cancer (or history of), undiagnosed irregular vaginal bleeding. Use in conjunction with an oestrogen: Consider contraindications relating to the oestrogen. B Epilepsy, history of migraine, asthma, hypertension, diabetics. Use with oestrogen (consider precautions for oestrogen). See SPC. Contains lactose. C Substances known to induce drugmetabolising enzyme cytochrome P450 enzymes, such as anticonvulsants (eg. phenobarbital, phenytoin, carbamezapine) and anti-infectives (e.g. rifampicin, rifabutin, nevirapine, efavirenz), ritonavir and nelfinavir, St John’s wort. A Headache, migraine, GI disorders, leg cramps, breast pain/tenderness, breakthrough bleeding, pelvic pain, asthenia, increase/decrease in weight.
FELDENE
McNeil Healthcare
Abbott 2 M O
2MO NSAID. Ibuprofen 800mg. White pillow-shaped, film-ctd sust.-release tab. marked BRUFEN RETARD. 56, A13.89. S Dysmenorrhoea. P 2 as a single dose, preferably in the early evening, swallowed whole with plenty of
NSAID. Piroxicam 10mg. Scarlet/blue cap. marked Pfizer and FEL 10. 28, A6.99. S Primary dysmenorrhoea. P Initially 40mg daily for the first 2 days then 20mg daily for the next 1-3 days as necessary. Q Under 16 years, not recommended.
PRESCRIBING NOTES DYSMENORRHOEA Dysmenorrhoea is pain in the lower abdomen, stemming from uterine cramps, during a menstrual period. The condition is called ‘primary dysmenorrhoea’ when no abnormality causing it is identified and ‘secondary dysmenorrhoea’ when an underlying gynaecological disorder is found to be the cause. The pain is thought to result from contractions of the uterus that occur when the blood supply to its lining (endometrium) is reduced and due to actions of prostaglandins in the endometrium. The pain occurs only at the completion of an ‘ovulatory’ menstrual cycle, i.e. one during which an egg was released. It does not occur after an ‘anovulatory’ cycle during which no egg was released. Drugs indicated for the management of primary dysmenorrhoea include: NSAIDs (ibuprofen, piroxicam, mefenamic acid, naproxen), COX-2 inhibitors (nimesulide, rofecoxib) and anticholinergics (hyoscine butylbromide). References available on request. Revised: July 2002
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
299
17.2 MENORRHAGIA
OBSTETRICS AND
D Aspirin/anti-inflammatory induced allergy. Active peptic ulcer, history of recurrent ulceration. B Impaired renal or hepatic function, elderly. Intracranial haemorrhage and bleeding diathesis. History of upper GI disease. Interstitial nephritis, glomerulonephritis, papillary necrosis and nephrotic syndrome reported rarely. Monitor patients with CHF, liver cirrhosis, nephrotic syndrome, overt renal disease and in long term use. Pregnancy, lactation. Contains galactose. Perform ophthalmic evaluation if visual complaints. C Warfarin, heparin; not recommended. Caution: Oral anticoagulants, anti-hypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporin, NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, other protein-bound drugs. A GI disturbances, oedema, CNS effects, rash and pruritus.
of colour vision, blurred vision, glucose intolerance in diabetics, hyponatraemia, facial / laryngeal oedema, skin/ renal/ hepatic/ blood disorders, hypersensitivity, anaphylaxis.
17.2 MENORRHAGIA
CYKLOKAPRON
Meda
2MO
Antifibrinolytic. Tranexamic acid 500mg. White oblong scored film-ctd tab. marked CY. 60, A15.04. S Short term use in haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Bleeding from local fibrinolysis e.g. menorrhagia, epistaxis, dental extractions in haemophiliacs. P Menorrhagia: 2-3 tabs. 3-4 times daily for 3-4 days. For other indications See SPC. Q 25mg/kg/dose. D Thromboembolic disease. B Early pregnancy. Impaired renal MEFAC Rowex function. Haematuria in haemophilia. History of thromboembolic disease. Perform regular eye tests 2MO Fenamate. Mefenamic acid 250mg blue/white cap. in patients with angioneurotic oedema. Rapid IV infusion may cause dizziness and/or hypertension. marked MEFAC 250. 500mg yellow oval-shaped A GI upset. Colour vision disturbance. film-ctd tab. marked MEF500. 250mg-100, A5.21; A A 500, 25.42; 500mg-100, 9.23. DECAPEPTYL SR Ipsen S Dysmenorrhoea. 6NT P 500mg three times daily. Q Not recommended. Gn-RH analogue. Triptorelin 3mg. 5ml vial D Ulcerative lesions of GI tract. Pregnancy, containing powder plus 2ml diluent. 1, A157.61. lactation. Renal or hepatic impairment. S Uterine fibromyomas. B Elderly. Bronchial asthma and allergic P 1 vial (3mg) as single IM inj. every 28 disorders. days. Start in to 5 days of cycle. See SPC. C Anticoagulants. Q Not applicable. A Diarrhoea, skin rash, headache, D Pregnancy. bronchospasm, GI disturbance. Renal impairment. B See SPC. A Hot flushes, vaginal dryness, loss of Thrombocytopenia. libido, rash, hair loss, asthenia, headache. See SPC.
PONSTAN
Chemidex
2MO NSAID. Mefenamic acid 250mg. Ivory/blue cap. marked PONSTAN 250. 100, A5.70; 500, A25.61.
2MO ALSO PONSTAN FORTE Mefenamic acid 500mg. Yellow film-ctd tab. 100, A10.40. S Primary dysmenorrhoea. Pre-menstrual syndrome. P Daily dose, 1500mg in divided doses. Q Under 12 years, not recommended. D Ulceration or inflammation of GI tract. IBD. Active or recurrent peptic ulcer/haemorrhage. Renal or hepatic impairment. Severe HF. Pregnancy, lactation. B Hypersensitivity (discontinue). Elderly, dehydration, renal disease, cardiac impairment, intracranial haemorrhage, bleeding diathesis, epilepsy, asthmatics, history of peptic ulceration or IBD, history of SLE, female fertility. Long term use: Monitor for liver function, rash, blood dyscrasias, diarrhoea. Contains: Lactose, quinoline/sunset yellow. C Contra: Other NSAIDs. Caution: Anticoagulants, lithium, SSRIs, antihypertensives, diuretics, ACE inhibitors, ARBs, aminoglycosides, cardiac glycosides, anti-platelets, methotrexate, ciclosporin, mifepristone, corticosteroids, quinolones, tacrolimus, probenecid, oral hypoglycaemics. A Diarrhoea, rash, GI toxicity, headache, convulsions, insomnia, dizziness, drowsiness, nervousness, asthma, dyspnoea, hypotension, palpitations, ear pain, eye irritation, reversible loss
300
GYNAECOLOGY
A Bone pain, libido decreased, hot flushes, mood changes, headache, vaginal disorders, perspiration. Hypersensitivity, depressive mood, irritability, nausea, myalgia, arthralgia, tiredness, sleep disorders, inj. site pain/reaction.
MIRENA
Bayer Schering
2NO IUS. Levonorgestrel 52mg. T-shaped intrauterine system. 1, A107.88. S Idiopathic menorrhagia. P To be inserted into the uterine cavity within 7 days of the onset of menstruation. Replace after 5 years. Delay post-partum use until 6 weeks after delivery. D Pregnancy, pelvic inflammatory disease, postpartum endometritis, infected miscarriage (past 3 months), cervicitis, cervical dysplasia, uterine or cervical malignancy, undiagnosed genital bleeding, uterine anomaly, genital infection, acute liver tumour, severe hepatic disease, progestogen-dependent tumours. B Severe arterial disease, migraine, exceptionally severe headache, jaundice, marked increase of BP, hormone dependent neoplasia incl. breast cancer, history of thromboembolism, may affect glucose tolerance. Lactation. C Caution: Liver enzyme inducing drugs. A Weight gain, oedema, headache, lower abdominal pain, back pain, acne, vaginal discharge, cervicitis, dysmenorrhea, mastalgia, breast tension, depression, mood changes, nausea, expulsion.
PONALGIC
Antigen
2MO NSAID. Mefenamic acid 250mg. Yellow/blue cap. marked ANTIGEN and coded MA250. 100, A4.67; 500, A23.81.
2MO
ALSO PONALGIC FORTE TABLETS Mefenamic acid 500mg. Yellow film-ctd tab. marked with logo and coded MA500. 100, A9.31. Progestogen. Dydrogesterone 10mg. White scored S Mild to moderate pain incl. headache, tab. marked S and 155. 42, A8.16. dental or post-op pain, rheumatic, muscular or S Dysfunctional bleeding. arthritic pain. Primary dysmenorrhoea. P To arrest bleeding, 1 twice daily Dysfunctional menorrhagia. together with an oestrogen for 5-7 days. To P 500mg three times daily. prevent bleeding, 1 twice daily together with an Q Not recommended. oestrogen from day 11 to 25 of the cycle. D Ulcerative lesions or inflammation of GI D See section 17.1. tract. Renal or hepatic impairment. Pregnancy, lactation. Aspirin/NSAID induced bronchospasm, GONAPEPTYL DEPOT Ferring rhinitis or urticaria. B Elderly. Renal dysfunction. Regular 6NT surveillence if therapy is prolonged. Discontinue if Gn-RH analogue. Triptorelin (acetate) 3.75mg. liver dysfunction, rash, blood dyscrasias or Powder and solvent for inj. prolonged release in diarrhoea occur. Cardiac or hepatic impairment. A pre-filled syringe 1, 183.98. History of peptic ulcer or inflamatory bowel S Preoperative reduction of myoma size disease. Intracranial haemorrhage or bleeding to reduce bleeding and pain. P One syringe (3.75mg) by SC or deep IM diathesis. C Anticoagulants, other plasma protein inj. every 28 days, initiated in the first 5 days of bound drugs. Antihypertensives, diuretics, cycle; change inj. site each time. cardiacglycosides, lithium, methotrexate, Q Not applicable. cyclosporin, other NSAIDs, corticosteroids, D Osteoporosis. Pregnancy, lactation. aminoglycosides, probenecid, oral hypoglycaemics. B Careful diagnosis (e.g. laparoscopy). A GI disturbance, diarhoea, headache, Supervening metrorrhagia during treatment is bronchospasm, rash, renal dysfunction, abnormal (apart from 1st month); check oestrogen thrombocytopenia and other blood dyscrasias. level if occurs (see SPC). Use non-hormonal contraception during initial month of treatment. PONSTAN Chemidex Uterine myomas: Determine size of uterus and 2MO myoma regularly (see SPC). Decrease of bone NSAID. Mefenamic acid 250mg. Ivory/blue cap. density, allergic and anaphylactic reactions marked PONSTAN 250. 100, A5.70; 500, A25.61. reported. 2MO C Oestrogen.
DUPHASTON
Solvay
2NO
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
ALSO PONSTAN FORTE Mefenamic acid 500mg. Yellow film-ctd tab. 100, A10.40. S Dysfunctional menorrhagia. P Daily dose, 1500mg in divided doses. Q Under 12 years, not recommended. D Ulceration or inflammation of GI tract. IBD. Active or recurrent peptic ulcer/haemorrhage. Renal or hepatic impairment. Severe HF. Pregnancy, lactation. B Hypersensitivity (discontinue). Elderly, dehydration, renal disease, cardiac impairment, intracranial haemorrhage, bleeding diathesis, epilepsy, asthmatics, history of peptic ulceration or IBD, history of SLE, female fertility. Long term use: Monitor for liver function, rash, blood dyscrasias, diarrhoea. Contains: Lactose, quinoline/sunset yellow. C Contra: Other NSAIDs. Caution: Anticoagulants, lithium, SSRIs, antihypertensives, diuretics, ACE inhibitors, ARBs, aminoglycosides, cardiac glycosides, anti-platelets, methotrexate, ciclosporin, mifepristone, corticosteroids, quinolones, tacrolimus, probenecid, oral hypoglycaemics. A Diarrhoea, rash, GI toxicity, headache, convulsions, insomnia, dizziness, drowsiness, nervousness, asthma, dyspnoea, hypotension, palpitations, ear pain, eye irritation, reversible loss of colour vision, blurred vision, glucose intolerance in diabetics, hyponatraemia, facial / laryngeal oedema, skin/ renal/ hepatic/ blood disorders, hypersensitivity, anaphylaxis.
jaundice, Dubin-Johnson and Rotor syndromes, history of thromboembolic disorders. B Diabetes, epilepsy, migraine, asthma, hypertension, cardiac dysfunction. A Liver disturbances, nausea, hypersensitivity reactions.
ENDOMETRIOSIS 17.3 2NO
Progestogen. Medroxyprogesterone acetate 2.5mg, 5mg, 10mg. Orange scored tab. marked U64, blue scored tab. marked 286 and white scored tab. marked UPJOHN 50. 2.5mg-30, A2.18; 5mg-30, A4.43; 5mg-100, A14.75; 10mg-90, A27.51. S Dysfunctional (anovulatory) uterine PROSTAP SR Takeda bleeding.Mild to moderate endometriosis.Secondary amenorrhoea. 6NT P Endometriosis: 10mg three times daily LHRH analogue. Leuprorelin acetate 3.75mg. starting on the first day of cycle for 90 consecutive Powder and 1ml solvent for prolonged-release days. Dysfunctional uterine bleeding: 2.5-10mg suspension for inj. 1, A163.01. daily for 5-10 days commencing day 16-21 of cycle S Management of oestrogen dependent and given for 2 consecutive cycles. Secondary gynaecological disorders: pain/lesions associated with endometriosis, uterine fibroids to reduce size amenorrhea: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle and repeated for 3 and associated bleeding (preoperative), consecutive cycles. endometrial preparation prior to intrauterine Q Not applicable. surgery (endometrial ablation/resection). D History of thromboembolic disorders. P 3.75mg admin. by SC or IM inj. once Liver dysfunction, pregnancy. monthly. Initiate during days 3-5 of menstrual B History of depression, diabetes, epilepsy, cycle. Max. 6 months. Co-admin. with HRT: migrane, asthma, cardiac or renal dysfunction. treatment up to 12 months for chronic C Aminoglutethimide. symptomatic endometriosis. A Thromboembolic disorders, insomnia, 6NT fatigue, rash, weight gain. ALSO PROSTAP 3 Leuprorelin (acetate) 11.25mg. Powder as microsphere depot in vial plus 2ml 17.3 ENDOMETRIOSIS diluent. 1, A489.03. P 11.25mg as single SC inj. at 3 month DECAPEPTYL SR Ipsen intervals. 6 N T Q Not applicable. Gn-RH analogue. Triptorelin 3mg. 5ml vial D Pregnancy, lactation, undiagnosed containing powder plus 2ml diluent. 1, A157.61. abnormal vaginal bleeding. S Endometriosis. B Diabetics (monitor blood glucose). PRIMOLUT N Bayer Schering Regular menstruation, fibroids (confirm diagnosis), P 1 vial (3mg) as single IM inj. every 28 days. Start in first 5 days of cycle. See SPC. ovarian mass (exclude prior to treatment), 2NO Q Not applicable. increased uterine cervical resistance, major risk Progestogen. Norethisterone 5mg. White tab. 6NT marked AN in a hexagon. 30, A3.21; 100, A10.71. factors for decreased bone mineral content. ALSO DECAPEPTYL 3-MONTH Triptorelin 11.25mg. Hepatic dysfunction and jaundice reported; close S Dysfunctional bleeding, endometriosis. observation. Spinal fracture, paralysis, hypotension Powder in vial plus 2ml diluent. 1, A431.71. P Dysfunctional bleeding, 1 three times and worsening of depression have been reported. P 1 vial (11.25mg) as single IM inj. at 3 daily over 10 days. To prevent recurrence, admin. month intervals. Start in first five days of cycle. A Oedema, hypertension, palpitations, prophylactically during next 3 cycles (1 twice or See SPC. three times daily from day 19-26). Endometriosis, 1 fatigue, muscle weakness, GI upsets, headache, Q Not applicable. twice daily starting on day 5 increasing to 2 twice bone/muscle pain, dizziness, insomnia, liver D Pregnancy daily if spotting occurs. Continue with initial dose function test increases, inj. site reactions, changes B See SPC. in blood lipids/glucose. Hot flushes, depression, for 4-6 months. A Hot flushes, vaginal dryness, decrased vaginal dryness. Q Not applicable. libido, rash, hair loss, asthenia, headache, transient D Pregnancy, liver dysfunction. History Pharmacia hypertension, transient sight disturbances may during pregnancy of general pruritus or idiopathic PROVERA occur. See SPC. PRESCRIBING NOTES MENORRHAGIA Menorrhagia is defined as heavy but regular menstrual bleeding occurring over several consecutive cycles. It affects around 1 in 20 women aged 30-49. It is thought to be caused by disordered prostaglandin production within the endometrium. The treatment objective in menorrhagia is to alleviate heavy menstrual flow and, consequently, to improve quality of life. Iron deficiency anaemia must also be prevented. In approximately half the number of hysterectomies performed, menorrhagia is the presenting problem. About half of all women who have a hysterectomy for menorrhagia have a normal uterus removed. NSAIDs (mefanamic acid) reduce heavy menstrual blood loss by inhibiting the synthesis of the prostaglandins in the endometrium, which causes increased blood flow by causing vasodilation and by inhibiting platelet aggregation. Antifibrinolytic drugs (tranexamic acid) act by inhibiting the activation of plasminogen into plasmin, thus reducing fibrinolysis and haemorrhage. Antifibrinolytic drugs and NSAIDs are both effective in reducing heavy menstrual blood loss in women with intrauterine contraceptive devices, as these patients tend to have high levels of fibrinolytic activity. Combined oral contraceptives or the levonorgesterel-releasing IUD can be used to reduce menstrual blood loss, and are particularly useful in women who also require contraception. Continued use of long-acting progestogens renders most women amenorrhoeic and therefore could be considered for use in menorrhagia. There is little clinical trial evidence to show that low dose, luteal phase administration of norethisterone, ethamsylate, danazol and GnRH analogues are an effective treatment for menorrhagia. References available on request.
DUPHASTON
Solvay
2NO Progestogen. Dydrogesterone 10mg. White scored tab. marked S and 155. 42, A8.16. S Endometriosis. P 1 two or three times daily from day 5 to 25 of the cycle or continuously. D See section 17.1.
GONAPEPTYL DEPOT
Ferring
6NT Gn-RH analogue. Triptorelin 3.75mg. Powder and solvent for inj. prolonged release in pre-filled syringe. 1, A183.98. S Symptomatic endometriosis. P One syringe (3.75mg) by SC or deep IM inj. every 28 days, initiated in the first 5 days of cycle; change inj, site each time. Q Not applicable. D Osteoporosis. Pregnancy, lactation. B Careful diagnosis (e.g. laparoscopy). Supervening metrorrhagia during treatment is abnormal (apart from 1st month); check oestrogen level if occurs (see SPC). Use non-hormonal
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
301
17.3 ENDOMETRIOSIS
OBSTETRICS AND
P Dysfunctional bleeding, 1 three times daily over 10 days. To prevent recurrence, admin. prophylactically during next 3 cycles (1 twice or three times daily from day 19-26). Endometriosis, 1 twice daily starting on day 5 increasing to 2 twice daily if spotting occurs. Continue with initial dose for 4-6 months. Q Not applicable. D Pregnancy, liver dysfunction. History during pregnancy of general pruritus or idiopathic jaundice, Dubin-Johnson and Rotor syndromes, history of thromboembolic disorders. PRIMOLUT N Bayer Schering B Diabetes, epilepsy, migraine, asthma, hypertension, cardiac dysfunction. 2NO A Liver disturbances, nausea, Progestogen. Norethisterone 5mg. White tab. marked AN in a hexagon. 30, A3.21; 100, A10.71. hypersensitivity reactions. S Dysfunctional bleeding, endometriosis.
contraception during initial month of treatment. Uterine myomas: Determine size of uterus and myoma regularly (see SPC). Decrease of bone density, allergic and anaphylactic reactions reported. C Oestrogen. A Bone pain, libido decreased, hot flushes, mood changes, headache, vaginal disorders, perspiration. Hypersensitivity, depressive mood, irritability, nausea, myalgia, arthralgia, tiredness, sleep disorders, inj. site pain/reaction.
PRESCRIBING NOTES ENDOMETRIOSIS Endometriosis is a relatively common condition that can cause significant pain and suffering. It effects between 3-10% of women aged between 15-45 years. In women who have difficulties conceiving, this rises to about 25-35%. Usually it does not occur before puberty, and it can present for the first time in women who have already had children. It is caused by the presence of endometrial tissue outside the uterine cavity. The endometrial growths respond to the hormones of the menstrual cycle, build up of tissue each month, break down, and cause bleeding. The endometrial tissue outside the uterus has no way of leaving the body, resulting in internal bleeding, degeneration of the blood and tissue shed from the growths which inflames the surrounding areas, and forms scar tissue. The most common symptoms of endometriosis are pain before and during periods, during or after sexual activity, infertility, and heavy or irregular bleeding. Other symptoms may include fatigue, painful bowel movements with periods, lower back pain with periods, diarrhoea and/or constipation and other intestinal upset with periods. Treatment of endometriosis with drugs can result in great improvement of symptoms. Medical treatment does not improve infertility and if hormonal contraceptives are used as a treatment it will delay it further. While medical treatment suppresses endometriosis, it does not remove it and is effective only for short term management of symptoms, the active endometriosis returning gradually after cessation of treatment. The aim of medical treatment is to break the cycle of stimulation and bleeding, stopping the usual hormonal cycle of the ovary and reducing oestrogen levels, causing the endometriosis deposits to shrink and become inactive. Ovarian endometriomas of greater than 3cm diameter and large quantities of adhesions are unlikely to respond to medical treatment, and will respond best to laparoscopic breakdown (adhesiolysis). Contraceptive pill is one of the most commonly used treatments for endometriosis, and is a good choice for young women with mild disease who also require effective contraception. It is often used to keep the disease in remission. Progestogens (medroxyprogesterone acetate, hydrogesterone and norethisterone) are the most commonly used medical treatment and are effective in about 80% of cases. They work by thinning out and shrinking the endometriosis and also by suppressing the normal cycle of the ovary. They can be used either continuously or cyclically. Depot Provera, the injection form of the drug is limited in women wishing pregnancy as it can delay ovulation for some time after the last injection (up to 12 months). Side effects of progestogens can include irregular bleeding or breakthrough spotting (affecting around one third of users), weight gain, breast tenderness, water retention and rarely depression. Breakthrough bleeding can be managed with a short course of oestrogen tablets. Progestogens can also alter the blood lipids, which might lead to an increased risk of thrombosis especially in patients with risk factors. GnRH analogues: Goserelin, nafarelin, buserelin, triptorelin and leuprorelin. GnRH is produced in the pituitary and stimulates the ovary to develop eggs and produce oestrogen, leading to the normal menstrual cycle. GnRH analogues flood the system leading to a complete block of egg development, oestrogen production and menstrual cycle; endometriosis shrinks and becomes inactive. The effectiveness of GnRH analogues is comparable with the other forms of medical treatment. The oestrogenaemia caused by these drugs produces unwanted symptoms normally associated with the menopause: Hot flushes, reduced sex drive, vaginal dryness, emotional symptoms, depression and headaches. Reduction in bone density may limit treatment to less than 6 months, though this is completely reversed 9 months after stopping treatment. GnRH analogues are not contraceptives and additional methods should be used. Danazol is also as effective as other treatments. It works by preventing ovulation and reducing oestrogen levels as well as having a directly suppressive effect on the endometriosis. It is structurally similar to the male hormone testosterone and consequently has side effects including weight gain, water retention, tiredness, decreased breast size, hot flushes, acne, oily skin, growth of facial hair and emotional symptoms. Some side effects are experienced by about 80% of users, 10% of users will cease treatment because of them. It can irreversibly deepen the voice. It is also important to use an effective contraceptive, as accidental use in early pregnancy can masculinise a female foetus. References available on request.
302
GYNAECOLOGY
PROSTAP SR
Takeda
6NT LHRH analogue. Leuprorelin acetate 3.75mg. Powder and 1ml solvent for prolonged-release suspension for inj. 1, A163.01. S Management of oestrogen dependent gynaecological disorders: pain/lesions associated with endometriosis, uterine fibroids to reduce size and associated bleeding (preoperative), endometrial preparation prior to intrauterine surgery (endometrial ablation/resection). P 3.75mg admin. by SC or IM inj. once monthly. Initiate during days 3-5 of menstrual cycle. Max. 6 months. Co-admin. with HRT: treatment up to 12 months for chronic symptomatic endometriosis.
6NT ALSO PROSTAP 3 Leuprorelin (acetate) 11.25mg. Powder as microsphere depot in vial plus 2ml diluent. 1, A489.03. P 11.25mg as single SC inj. at 3 month intervals. Q Not applicable. D Pregnancy, lactation, undiagnosed abnormal vaginal bleeding. B Diabetics (monitor blood glucose). Regular menstruation, fibroids (confirm diagnosis), ovarian mass (exclude prior to treatment), increased uterine cervical resistance, major risk factors for decreased bone mineral content. Hepatic dysfunction and jaundice reported; close observation. Spinal fracture, paralysis, hypotension and worsening of depression have been reported. A Oedema, hypertension, palpitations, fatigue, muscle weakness, GI upsets, headache, bone/muscle pain, dizziness, insomnia, liver function test increases, inj. site reactions, changes in blood lipids/glucose. Hot flushes, depression, vaginal dryness.
PROVERA
Pharmacia
2NO Progestogen. Medroxyprogesterone acetate 2.5mg, 5mg, 10mg. Orange scored tab. marked U64, blue scored tab. marked 286 and white scored tab. marked UPJOHN 50. 2.5mg-30, A2.18; 5mg-30, A4.43; 5mg-100, A14.75; 10mg-90, A27.51. S Dysfunctional (anovulatory) uterine bleeding.Mild to moderate endometriosis.Secondary amenorrhoea. P Endometriosis: 10mg three times daily starting on the first day of cycle for 90 consecutive days. Dysfunctional uterine bleeding: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle and given for 2 consecutive cycles. Secondary amenorrhea: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle and repeated for 3 consecutive cycles. Q Not applicable. D History of thromboembolic disorders. Liver dysfunction, pregnancy. B History of depression, diabetes, epilepsy, migrane, asthma, cardiac or renal dysfunction. C Aminoglutethimide. A Thromboembolic disorders, insomnia, fatigue, rash, weight gain.
SUPRECUR
sanofi-aventis
6NO LH-RH analogue. Buserelin 150mcg (acetate) per dose; nasal spray. 2 x 10g with nebuliser type metered dose pump, A90.79. S Endometriosis in cases that do not
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
require surgery or primary therapy. P Women over 18 years, 1 application in each nostril in the morning, at midday and in the evening for a max. 6 months. Start therapy on first or second day of cycle. Q Not applicable. D Post menopausal women, pregnancy, lactation. Undiagnosed vaginal bleeding, hormone dependant neoplasms. B Pregnancy test if there is a possibility of pregnancy. Impaired renal or liver function. C Oral contraceptives. A Menopause like symptoms and withdrawal bleeding, bone mineral loss with prolonged use. Recovery of HPG function usually occurs within 8 weeks of discontinuing treatment.
and efficacy not established), severe hepatic or renal impairment (consider potential risk/benefit). Loss of bone mineral density, increased fracture risk. C Co-admin. of tamoxifen, oestrogencontaining therapies (decreased Arimidex pharmacological action) A Hot flushes, asthenia, joint pain/ stiffness, vaginal dryness, hair thinning, rash, nausea, diarrhoea, headache, carpal tunnel syndrome, hepatobiliary disorders.
BREAST DISORDERS 17.4 antibiotics, anti-psychotics. A Nausea, headache, dizziness, abdominal pain, fatigue, constipation, vomiting, breast pain, hot flushes, depression, paresthesia.
FARESTON
Orion
5MO
Anti-oestrogen. Toremifene 60mg. White tab. marked TO60. 30, A34.31. S First line hormone treatment of hormone dependent metastatic breast cancer in postmenopausal patients. AROMASIN Pharmacia P 1 daily 5NO Q Not applicable. Irreversible aromatase inhibitor. Exemestane 25mg. D Pre-existing endometrial hyperplasia, Round, biconvex, white ctd tab. marked 7663. 30, severe hepatic failure, QT prolongation, electrolyte A135.00. disturbances (eg. hypokalaemia), bradycardia, SYNAREL NASAL SPRAY Pharmacia S Adjuvant treatment of post-menopausal heart failure with reduced left-ventricular ejection 6NT fraction, history of symptomatic arrhythmias. women with oestrogen receptor positive invasive Pregnancy, lactation. early breast cancer, following 2-3 years of initial GnRH analogue. Nafarelin (as acetate) 2mg/ml; B Proarrhythmic conditions (especially in Clear, colourless to slightly yellow nasal spray soln. adjuvant tamoxifen therapy. Advanced breast elderly) eg. acute myocardial ischaemia or QT cancer in post-menopausal women where disease 200mcg per metered spray soln. 60 dose unit, A79.36. prolongation; monitor for cardiac arrhythmia has progressed following anti-oestrogen therapy. (discontinue if occurs). Non-compensated cardiac P 1 daily preferably after meal. Early S Endometriosis. P 1 spray (200mcg) twice daily as one breast cancer, continue until completion of 5 years insufficiency, severe angina, bone metastases, spray to one nostril in the morning and 1 spray in sequential adjuvant hormonal therapy (tamoxifen severe thromboembolic disease (avoid), additional risk of endometrial cancer, liver impairment. the other nostril in the evening. Initiate treatment followed by Aromasin) or tumour relapse. C Contra: Drugs prolonging QT interval. between days 2 and 4 of the menstrual cycle. The Advanced, continue until tumour progression. Avoid warfarin-type anticoagulants. Caution: recommended duration of treatment is 6 months. Q Not recommended. Thiazide diuretics, enzyme inducers (eg. Do not retreat. D Pre-menopausal women. Pregnancy, phenobarbital, phenytoin and carbamazepine), Q Not applicable. lactation. CYP3A4 inhibitors (see annexe). D Hormone dependent neoplasms. B Caution: Hepatic/ renal impairment; A Hot flushes, depression, sweating, rash, Pregnancy, lactation. Undiagnosed vaginal osteoporosis (or at risk of), assess bone mineral nausea, vomiting, leukorrhoea, dizziness, oedema, bleeding. density before use. Contains sucrose, methyl-puterine bleeding, fatigue. B Missed doses potential for conception. hydroxybenzoate. Hepatitis/ cholestatic hepatitis A Hot flushes, vaginal dryness, headache, reported. FEMARA Novartis changes in libido, emotional lability, myalgia, C Oestrogen-containing drugs (contra). decreased breast size, irritation of nasal mucosa, 5NO CYP3A4 substrates and inducers (caution). small reduction in bone density. A Anorexia, hot flushes, depression, Aromatase inhibitor. Letrozole 2.5mg. Yellow headache, GI disorders, fatigue, sweating, rash, round coated tab. marked FV on one side and CG ZOLADEX AstraZeneca alopecia, joint/ musculoskeletal pain, dizziness, on reverse. 30, A93.26. 6NT carpal tunnel syndrome, pain, peripheral oedema. S Extended adjuvant treatment of hormone dependent early breast cancer in GnRH analogue. Goserelin 3.6mg in a DOSTINEX Pharmacia postmenopausal women having received 5 years biodegradable depot. Single-dose syringe of tamoxifen therapy. Treatment of hormone applicator. 1 (month course), A159.50. 2NO dependent advanced breast cancer in postS Endometriosis. Dopamine agonist. Cabergoline 0.5mg. White menopausal women (1st line or after relapse/ P Initial treatment should be in hospital. capsule shaped flat scored tabs. marked P and U progression with antiestrogens). One 3.6mg depot SC inj. into anterior abdominal on one face and 700 on the other. 8, A34.01. P 1 daily. wall every 28 days for max. 6 months. S Hyperprolactinaemic disorders incl. Q Not applicable. amenorrhoea, oligomenorrhoea, anovulation and Q Not applicable. D Premenopausal endocrine status. D Pregnancy; non-hormonal methods of galactorrhoea. Prolactin secreting pituitary Pregnancy, lactation. contraception should be used throughout adenomas, empty sella syndrome with associated B Severe renal or hepatic impairment. If treatment. Lactation. idiopathic hyperprolactinaemia and idiopathic risk of osteoporosis, assess BMD and monitor. B Patients at risk of osteoporosis. hyperprolactinoma. C Caution: CYP2A6 and 2C19 substrates A Hot flushes, loss of libido, headaches, P Initially 1 tab. per week in one or two mood changes and vaginal dryness, change in doses. If necessary, increase gradually by 1 tab. per with narrow therapeutic index. A Increased sweating, hot flushes, fatigue, breast size, rashes. week at monthly intervals. Usual maintenance weight increase, appetite change, dose 2 tabs. per week in single or divided doses; 17.4 BREAST DISORDERS max. 9 tabs. per week. Tabs. should be taken with hypercholesterolaemia, headache, dizziness, GI disorders, alopecia, rash, oedema, myalgia, bone food. ARIMIDEX AstraZeneca pain, arthralgia, arthritis, osteoporosis, bone Q Not recommended. fractures. 5NO D Hypersensitivity to ergot alkaloids. Aromatase inhibitor. Anastrozole 1mg. White Hepatic insufficiency, toxaemia of pregnancy. HERCEPTIN Roche biconvex film-ctd. tab. embossed with logo on one Lactation. Do not co-administer with anti2N side and strength on reverse. 28, A89.08. psychotics. Monoclonal antibody. Trastuzumab 150mg. S Treatment of early breast cancer in B Evaluate pituitary prior to treatment. Powder for soln. for inf. in vial. 1 vial. Price on hormone receptive post-menopausal women. Renal, hepatic or cardiac disease, Raynaud’s request. Treatment of advanced breast cancer in post syndrome, GI ulceration or bleeding. Psychotic menopausal women. S Treatment of patients with metastatic disorders. Monitor gynaecological changes. P 1mg once daily. No dose change in breast cancer whose tumours overexpress HER2 Discontinue at least 1 month before trying to renal or hepatic impairment. (see SPC). Treatment of HER2 positive early breast conceive. Use mechanical contraception if Q Not recommended. cancer following surgery, chemotherapy conception is not desired. See SPC. D Pregnancy, lactation. (neoadjuvant or adjuvant) and radiotherapy. C Long-term ergot alkaloids, dopamine B Children/pre-menopausal women (safety agonists, dopamine antagonists, macrolide P Initial loading dose: 4mg/kg body AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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weight followed by weekly dose of 2mg/kg body weight beginning one week after loading dose. Doses should be administered as a 90-minute IV inf. Observe patients for at least 6 hours after the first inf. and for 2 hours after the start of subsequent inf. for symptoms (fever, chills, other infusion-related symptoms). Interruption of inf. may help control such symptoms, inf. may be resumed when symptoms abate. Q Under 18 years, not recommended. D Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. Lactation. B Monitor for cardiotoxicity and inf. reactions. Pulmonary events (dyspnoea, bronchospasm, asthma, hypoxia) can occur as part of inf. reaction. Pregnancy. PRESCRIBING NOTES BREAST DISORDERS Breast pain in women is unlikely to be due to any malignancy especially those under 35. Most patients once reassured may only require alteration of any hormonal therapy they may be receiving (HRT, oral contraceptives), change in diet to reduce dietary fat or even altering underwear. Examination of the breast may reveal a lump, which would require further investigation, possibly referral to a specialist for evaluation; most will be benign or cysts. Lactational inflammation should be treated with antibiotics. Galactorrhoea may be caused as a side effect of another drug treatment or due to a pituitary disorder. Persistent pain and unexplained discharge from the nipple or changes in appearance should be considered for referral. The pain may be cyclical in nature and an exaggeration of the normal pre-menstrual tenderness, this may respond well to simple analgesia. If unsuccessful, danazol or bromocriptine may be beneficial, both however have unpleasant side effects. Gamolenic acid in contrast does not have these side effects, and may be more appealing. It acts by decreasing the breast response to ovarian hormones and prolactin; it has a slow onset of action and takes 8-12 weeks to take effect. Tamoxifen is an oestrogen-receptor antagonist used to treat women with oestrogen-receptorpositive breast cancer with and without metastases. Patients who respond to tamoxifen may respond to second line hormone treatment â&#x20AC;&#x201C; for premenopausal women, ovarian ablation or use of a progesterone; in postmenopausal women an aromatase inhibitor or progesterone. Toremifene is also an oestrogen receptor antagonist and indicated for treatment of hormone dependent metastatic breast cancer in postmenopausal women. Anastrozole and letrozole are non-steroidal aromatase inhibitors, and act by blocking the conversion of androgens to oestrogens in peripheral tissues. Formestane and exemestane are steroidal aromatase inhibitors, and are indicated in advanced breast cancer in postmenopausal women. References available on request.
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D Toxaemia of pregnancy, puerperal postpartum hypertension, coronary disease. Hypersensitivity to ergot alkaloids. B History of peptic ulceration, psychotic or severe cardiovascular disorders. Perform regular gynaecological assessment for women receiving prolonged therapy. Observe patients on long-term high doses for manifestations of retroperitoneal fibrosis. C Alcohol, erythromycin, Psyhoactive MEGACE BMS agents, drugs effecting BP. A Postural hypotension, nausea, vomiting, 2NO Progestogen. Megestrol acetate 160mg. Off-white mild constipation, dry mouth, leg cramps, vasospasm, hypertension, MI, strokes, drowsiness, oval scored tab. marked 160. 160mg-30, A34.10. S Certain hormone dependent neoplasms confusion, hallucinations, headache, dizziness, seizures, episodes of reversible pallor of fingers (e.g. endometrial or breast carcinoma). Cachexia: and toea induced by cold, psychomotor exitation, See Megace Oral Suspension section 20.1. P Breast carcinoma, 160mg daily in single dyskinesia, retroperitoneal fibrosis. or divided doses for min. period of 2 months. TAMOX Rowex Endometrial, see 20.1. 5MO Q Not applicable. D Pregnancy, lactation. Anti-oestrogen. Tamoxifen (citrate) 10mg, 20mg. B Thrombophlebitis. White film-ctd tabs. 10mg-30, A6.08; 20mg-30, A Weight gain, nausea, vomiting, oedema, A7.21. breakthrough uterine bleeding, urticaria. S Palliative management of breast cancer. P 20-40mg once daily. NOLVADEX-D AstraZeneca Q Not applicable. D Pregnancy. 5MO B Lactation. Contains lactose. Anti-oestrogen. Tamoxifen (citrate) 20mg. White octagonal film-ctd tab. marked NOLVADEX-D. 30, C Coumarin-type anticoagulants, cytotoxic agents (increased risk of thromboembolic events). A4.33. A Hot flushes, vaginal bleeding/discharge, S Breast cancer. P 20-40mg daily; as single dose or divided pruritus vulvae, GI intolerance, dizziness, tumour flare, visual disturbances, skin rash, pulmonary in 2. embolism. Q Not recommended. D Pregnancy, lactation. ZOLADEX AstraZeneca B Increased incidence of endometrial 6NT cancer, uterine sarcoma. Second primary tumours reported. Contains lactose. GnRH. Goserelin (acetate) 3.6mg in a C Caution: Coumarin-type anticoagulants, biodegradable depot. Single-dose syringe cytotoxic agents. CYP3A4 inducers, CYP2D6 applicator. 1 (month course), A159.50. inhibitors. S Breast cancer in pre and periA Hot flushes, thrombolitic/ menopausal women suitable for hormone cerebrovascular events, vaginal bleeding/discharge, manipulations. pruritus vulvae, endometrial changes, GI distress, P One 3.6mg depot SC inj. into anterior dizziness, fluid retention, headache, rash, alopecia, abdominal wall every 28 days. tumour flare, leg cramps. Q Not applicable. D Pregnancy, lactation. PARLODEL Meda A Hot flushes, decreased libido, breast swelling and tenderness, rashes, headache, 2MO emotional lability, vaginal dryness, hypercalcaemia. Dopamine agonist. Bromocriptine (as mesylate) 2.5mg. White tab. scored and marked XC one side 17.5 MENOPAUSAL DISORDERS, Sandoz on reverse. 30, A6.44; 100, A21.47. OSTEOPOROSIS 2MO A Fever, chills, abdominal pain, asthenia, chest pain, headache, diarrhoea, nausea, vomiting, anorexia, constipation, dyspepsia, dry mouth, arthralgia, myalgia, rash, allergic reaction, infection, pain, vasodilation, tachycardia, hypotension, heart failure, cardiomyopathy, palpitation, leucopenia, peripheral oedema, leg cramps, arthritis, anxiety, depression, dizziness, insomnia, asthma, cough, UTI.
ALSO PARLODEL CAPSULES Bromocriptine (as mesylate) 5mg.B Blue/white cap. marked P. 100, A41.84. S Prevention or suppression of puerperal lactation. Hyperprolactinaemia. Cyclical benign breast disease, severe mastalgia. Prolactinomas. P Lactation prevention: initially 2.5mg on day of delivery then 2.5mg twice daily with meals for 14 days. Suppression of lactation: initially 2.5mg on first day increasing after two or three days to 2.5mg twice daily with meals for 14 days. Prevention of lactation: initially 2.25mg on day of delivery, then 2.5mg twice daily with meals for 14 days. Hyper prolactinaemia: initially 1.25mg at night, increasing after two or three day intervals to 7.5mg daily in divided doses with meals; max. 30mg daily. Benign breast disease/severe mastalgia: 2.5mg twice daily. Prolactinomas: up to 30mg daily. Q Not applicable
ACLASTA
Novartis
2JN Bisphosphonate. Zoledronic acid anhydrous 5mg/ 100ml. Soln for inf. 100ml, A499.84. S Osteoporosis in post-menopausal women and in men at increased risk of fracture including those with recent low-trauma hip fracture. Osteoporosis associated with long-term systemic glucocorticoid therapy. P Once a year IV inf. of 5mg in 100ml soln over at least 15 min, admin. via vented inf. line at constant inf. rate. D Hypocalcaemia. Pregnancy, lactation. B Severe renal impairment (avoid). Ensure adequate hydration. Treat disturbances of mineral metabolism first. Vit D intake recommended following inf. Ensure adequate Ca++ suppl. (at least 500mg Ca++ twice daily for min. 10 days following inf). Monitor for symptoms of hypocalcaemia.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
MENOPAUSAL DISORDERS,
OSTEOPOROSIS
17.5
each week. Take Actonel 35mg in upright position and do not lie down for 30 min. D Hypocalcaemia, hypercalcaemia, hypercalciuria, nephrolithiasis, severe renal impairment. Pregnancy, lactation. B Caution: History of oesophageal disorders (e.g. stricture, achalasia), patients unable ACTIVELLE Novo Nordisk to stay in upright position for at least 30 min, active or recent oesophageal or upper GI 2NO problems. Treat disturbances of bone and mineral Oestrogen/progestogen (continuous combined). metabolism first. Mild to moderate renal Estradiol (hemihydrate) 1.03mg (equiv. to anhydrous estradiol 1mg), norethisterone (acetate) impairment, history of absorptive or renal hypercalciuria, nephrocalcinosis, kidney stone 0.5mg. White film-ctd tab. 28, A11.20. S HRT for oestrogen deficiency symptoms formation, hypophosphataemia;++ monitor renal in women more than 1 year after menopause with function, serum and urinary Ca and phosphate. Contains lactose. an intact uterus. Prevention of osteoporosis in C Caution: Products containing polyvalent post menopausal women. cations, thiazide diuretics, systemic corticosteroids, P 1 daily without break starting at cardiac glycosides, bisphosphonates or Na+ anytime if not menstruating or if transferring from other continuous combined HRT products. In fluoride, tetracycline, oxalic acid, phytic acid. A Headache, GI disorders, musculoskeletal women transferring from sequential regimens pain. start right after withdrawal bleeding has ended. Q Not applicable. ACTONEL ONCE A WEEK P & GP/ D See SPC.
C Caution: Drugs impacting renal function (e.g. aminoglycosides, diuretics). A Flu-like symptoms, hypocalcaemia, headache, lethargy, dyspnoea, diarrhoea, nausea, dyspepsia, bone pain, arthralgia, myalgia, pyrexia, rigors, fatigue, pain, asthenia.
ALSO ACTONEL Risedronate (Na+) 5mg. Yellow oval film-ctd tab. marked RSN on one side and 5mg on reverse. 28, A28.34. S Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractured. Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis. To maintain or increase bone mass in postmenopausal women undergoing long-term systemic corticosteroid therapy. P 5mg daily. Tab. should be swallowed whole in an upright position, with a glass of water, at least 30 mins. before the first food or drink of the day or at least 2 hours from any other food or drink at other times and at least 30 mins. before retiring. Q Not recommended. D Hypocalcaemia, severe renal impairment (Q30ml/min). Pregnancy, lactation. B Caution: History of oesophageal disorders (e.g. stricture, achalasia), patients unable to stay in upright position for at least 30 min, active or recent oesophageal or upper GI sanofi aventis problems, disturbance of bone and mineral ACTONEL COMBI sanofi-aventis 2 N O metabolism. Hypocalcaemia, inadequate dietary 2NO Bisphosphonate. Risedronate (Na+) 35mg. Oval intake of Ca++ and vit. D. light-orange film-ctd tab. marked RSN one side, C Medications containing Ca++, Bisphosphonate/Ca++. Risedronate Na+ 35mg 35mg on reverse. 4, A30.84. magnesium, iron, alum. (equiv. risedronic acid 32.5mg), Ca++ carbonate ++ S Treatment of postmenopausal A GI disturbance, musculoskeletal pain, 1250mg (equiv. Ca 500mg). Film-ctd tabs. headache. osteoporosis, to reduce the risk of vertebral Risedronate Na+, oval, light-orange with RSN on one side and 35mg on reverse; Ca++, caps.-shaped, fractures. Treatment of established ACTONEL PLUS Ca & D P & GP/ postmenopausal osteoporosis, to reduce the risk of blue with NE 2 on both sides. 1 Actonel and 6 sanofi aventis hip fractures. Ca++, A34.86. S Postmenopausal osteoporosis, to reduce P 35mg once weekly taken 30 mins. 2MO before the first food, other medicines or drink risk of vertebral/hip fractures. Bisphosphonate/Ca++/vit D3. Tabs. contain (except water) of the day, on the same day each P 1 Actonel 35mg tab. on 1st day with risedronate Na+ 35mg (equiv. 32.5mg risedronic week and swallowed whole. water at least 30 min before 1st food of the day, acid). Effervescent granules contain Ca++ carbonate followed on the next day by 1 Ca++ tab. daily for 6 Q Not recommended. 2500mg (equiv. Ca++ 1000mg and colecalciferol days taken with meal. Repeat this 7 day sequence 2 N O (vit. D3) 22mcg (880 IU)). Oval, light-orange, filmctd tab. with RSN on one side and 35mg on Drug Prescribing Notes ● ALENDRONATE reverse. White effervescent granules. 4 tabs and Contraindications 24 sachets, A32.05. Abnormalities of the oesophagus and other factors which delay oesophageal emptying, such as stricture or S Postmenopausal osteoporosis, to reduce achalasia ● Inability to stand or sit upright for at least 30 minutes ● Hypocalcaemia. risk of vertebral fractures. Treatment of Special Precautions established postmenopausal osteoporosis, to Not recommended for renally insufficient patients (cc< 35ml/min) ● Causes of osteoporosis other than reduce risk of hip fractures. oestrogen deficiency and ageing should be considered ● May cause local irritation of mucous membranes in P 1 tab on day 1 followed the next day upper GI tract ● Caution: Existing active upper GI problems (dysphagia, oesophageal disease, gastritis, by 1 sachet daily for 6 days. Repeat 7 day duodenitis, ulcers, barrett’s oesophagus) ● Warn patients of side effects (sometimes severe and requiring sequence each week. Swallow tab whole on the hospitalisation) in the oesophagus (oesophagitis, oesophageal ulcer, oesophageal erosion, rarely followed by same day each week with water 30 min before 1st oesophageal stricture). Patients should discontinue and report symptoms of oesophageal irritation such as food, other medicinal product or other drink. Do dysphagia, pain when swallowing, retrosternal pain, new or intensified heartburn. Greater risk in patients not not lie down until 30 min after taking tab. taking dose correctly or continuing treatment despite symptoms ● Rare cases of gastric and duodenal ulcers D Hypocalcaemia, hypercalcemia, (some severe and with complications) ● Treat hypocalcaemia and other disturbances of mineral metabolism hypercalciuria. Diseases and/or conditions (e.g. vitamin D deficiency and hypoparathyroidism) before initiating treatment ● Symptomatic hypocalcaemia associated with hypercalcaemia/hypercalciuria. reported rarely; severe cases in patients with an underlying predispose condition (e.g. hypoparathyroidism, Nephrolithiasis. Pregnancy, lactation. Severe renal vitamin D deficiency or calcium malabsorption) ● Ensure sufficient intake of calcium and vitamin D in paimpairment. Hypervitaminosis D. tients receiving glucocorticoids ● Osteonecrosis of the jaw reported. Dental examination with appropriate B Caution: Very elderly, history of preventive dentistry should be considered prior to treatment in patients with concomitant risk factors (e.g. oesophageal disorders (e.g. stricture, achalasia), cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease). Avoid invasive patients unable to stay in upright position for at dental procedures if possible ● Femoral stress fractures may occur (long-term treatment). Pregnancy: No least 30 min, active or recent oesophageal or adequate data. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ upper GI problems. Correct disturbances of bone/ fetal development, or postnatal development. Alendronate given during pregnancy in rats caused dystocia mineral metabolism before treatment. related to hypocalcemia. Given the indication, alendronate should not be used during pregnancy. Lactation: Osteonecrosis of the jaw reported; consider dental It is not known whether alendronate is excreted into human breast milk. Given the indication, alendronate examination with appropriate preventive dentistry should not be used by breast-feeding women. prior to treatment in at risk patients. Avoid invasive dental procedures while on treatment. Drug Interactions ++ Monitor renal function, serum and urinary Ca++ Wait at least 30 min after taking alendronate before taking any other oral product (Ca supps, antacids). and phosphate regularly in patients with mildSide-Effects moderate renal impairment, or history of Headache, GI upset, oesophageal ulcer, dysphagia, abdominal distension/pain, acid regurgitation, absorptive or renal hypercalciuris, nephrocalcinosis, musculoskeletal pain. kidney stone formation, or hypohosphataemia. Revised November 2009 Long term treatment (monitor). Use with other AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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17.5 MENOPAUSAL
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drugs containing vitamin D. Patients with sarcoidosis. Immobilised patients. Tablet contains lactose. Granules contain sorbitol and sucrose. C Risedronate Na+: Polyvalent cations. Ca++ carbonate/vitamin D3: Thiazide diuretics, systemic corticosteroids. Tetracycline preparations (admin r2 hours before or 4-6 hours after Ca++ carbonate/vitamin D3). Digitalis and other cardiac glycosides. Na+ fluoride (admin r 3 hours before Ca++ carbonate/vitamin D3). Oxalic acid and phytic acid (do not take Ca++ within 2 hours). Ion exchange resins. A Headache, GI disorders, musculoskeletal pain.
ALENDRONIC ACID BENTLEY Bentley
2MO Bisphosphonate. Alendronic acid 70mg. White oval flat tab. marked 70. 4, A14.33. S Postmenopausal osteoporosis. Sodium alendronate reduces the risk of vertebral and hip fractures. P 70mg once weekly, at least 30 min before 1st food, beverage, or medicinal product of the day with plain water only (r 200ml). Do not lie down until after 1st food of the day (at least 30 min after taking tab). Q Not recommended. D For Prescribing information, see alendronate Drug Presc. Notes.
ANGELIQ
Bayer Schering
2NO Oestrogen/progestogen (continuous combined). Estradiol 1mg (as estradiol hemihydrate) and drospirenone 2mg. Medium red, round film-coated tab. with convex faces, marked DL in a regular hexagon. 3x28, A39.00 (1 month 28, A13.00). S HRT for oestrogen deficiency symptoms in women more than 1 year post menopause. Prevention of osteoporosis in postmenopausal women at high risk of fractures where other approved treatments are inappropriate. P 1 daily at same time each day without break. R Over 65 years, limited experience. D Undiagnosed genital bleeding, active/ past breast cancer, oestrogen-dependent malignant tumours, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism, active/ recent arterial thromboembolic disease (e.g. angina, MI), liver disease as long as liver function tests still abnormal, porphyria, severe renal insufficiency or acute renal failure. Pregnancy, lactation. B Perform regular check-ups and monitor for breast changes. Supervise closely: Leiomyoma or endometriosis, risk factors for thromboembolic disorders or for oestrogen dependent tumours, hypertension, liver disorders, diabetes mellitus with or without vascular involvement, cholelithiasis, migraine or headache, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis, cardiac or renal dysfunction. Discontinue: Jaundice or deterioration in liver function, significant increase in BP, new onset of migraine-type headache. C Caution: Cyt. P450 inducers (e.g. anticonvulsants, anti-infectives), ritonavir and nelfinavir, St. Johnâ&#x20AC;&#x2122;s wort, aldosterone antagonists or K+-sparing diuretics. A Abdominal pain or bloating, asthenia, pain in extremity, nausea, headache, mood swings,
306
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hot flushes, nervousness. Uterine fibroids enlarged, cervix neoplasm, leukorrhea, breakthrough bleeding, benign breast neoplasms, breast enlargement.
high risk of combined vit. D and Ca++ deficiencies. P 1 tab. twice a day with a large glass of water. Pregnant women: 1 tab. a day. Q Not recommended. D Renal failure. Hypercalciuria and BONVIVA Roche hypercalcaemia and diseases / conditions leading to hypercalcaemia and/or hypercalciuria (e.g. 2NO myeloma, bone metastases, primary Bisphosphonate. Ibandronic acid (as Na+ monohydrate) 150mg. White, oblong, film-ctd tab. hyperparathyroidism). Kidney stones (nephrolitiasis, nephrocalcinosis). Hypervitaminosis marked BNVA on one side and 150 on reverse. 1, D. Soya/peanut hypersensitivity. A27.73. S Osteoporosis in postmenopausal women B Caution: Prolonged treatment, immobilised patients, sarcoidosis, decreased renal at increased risk of fractures. Demonstrated treatment efficacy on vertebral fractures; efficacy on femoral function. Reduce or interrupt temporarily if urine Ca++ q 7.5mmol/24h (300mg/ neck fractures not established. 24h). Pregnancy, lactation. Contains sucrose. P 1 monthly on same date each month after overnight fast (at least 6 hrs) and 1 hr before C Caution: Thiazide diuretics, systemic corticosteroids, orlistat, combined ion-exchange 1st food, other drug or drink of day. Swallow whole in upright position and do not lie down for resin, paraffin, cardiac glycosides, phenytoin, barbiturates. Absorption may be reduced by 1 hr. Caltrate: Tetracycline, iron, zinc, strontium, Q Children and adolescents, not estramustin, thyroid hormones, bisphosphonate, recommended. sodium fluoride, fluoroquinolone. Foods rich in 2J oxalic or phytic acid may inhibit absorption. + ALSO BONVIVA IV Ibandronic acid (as Na monohydrate) 3mg. Pre-filled syringe. 3ml, CALVIDIN Ergha A103.89. P 3mg as an IV inj. over 15-30 sec every 3 2 O Y Calcium/vit. D suppl. Ca++ carb. 1500mg (equiv. months. Ca++ 600mg), cholecalciferol 4mg (equiv. vit. D3 Q Children and adolescents, not 10mcg/400 IU). White chewable scored tab. recommended. marked C/D. 60, A8.7451. D Hypocalcaemia, renal impairment S As an adjunct to specific treatment for (ccQ30ml/min). osteoporosis. B Treat hypocalcaemia and disturbances P 1-2 daily. of bone and mineral metabolism first. Ensure Q Not recommended. adequate Ca++ and vit. D intake. Osteonecrosis of D Hypercalcaemia, hypercalciuria. the jaw has been reported; consider dental C Tetracycline, fluoride, iron, cardiac examination in patients at risk. Tab: History of prolonged oesophageal transit time. Discontinue if glycosides, thiazide diuretics. A Mild GI disturbances, hypercalcaemia. oesophageal reaction occurs. C Tab: Products containing Ca++ and other CLIMARA Berlipharm multivalent cations (e.g. alum., magn., iron). A GI disturbances, flu-like illness, fatigue, 2NO myalgia, arthralgia. Rash (IV). Oestrogen. Estradiol 3.9mg (releasing 50mcg/day). Transdermal patch. 4, A7.08.
CALCICHEW D3 FORTE
Shire
2O
2NO
ALSO CLIMARA FORTE Estradiol 7.8mg (releasing 100mcg/day). Transdermal patch. 4, A9.16. S Oestrogen replacement therapy. Prevention of postmenopausal osteoporosis. P Use lowest effective dose. Apply on the trunk or buttocks. Do not apply on or near the breasts or use unopposed estrogen (except after hysterectomy). If a progestogen is necessary, use 2O at least for 12-14 days each month. Continuous ALSO CALCICHEW Ca++ carb. 1.25g (equiv. Ca++ use: Apply weekly. A 500mg). White chewable tab. 100, 13.49. Q Not applicable. P 2-6 daily. D Current or past breast cancer, oestrogen Q Not applicable. dependent malignant tumours, undiagnosed D Hypercalcaemia, hypercalciuria. genital bleeding, untreated endometrial C Tetracyclines, fluoride, iron, cardiac hyperplasia, previous idiopathic or current venous glycosides, thiazide diuretics. thromboembolism, active or recent arterial A Mild GI disturbance, hypercalcaemia. thromboembolic disease (e.g. angina, MI), acute or past liver disease, as long as liver function tests CALTRATE Wyeth Healthcare have failed to return to normal, porphyria. 2OY Pregnancy, lactation. ++ Calcium/vit. D suppl. Ca (as carbonate) 600mg, B Uterine fibroids or endometriosis, risk cholecalciferol 10mcg (eq. to 400 I.U. vit. D3). Cap.- factors for thromboembolic disorders or oestrogen shaped grey/beige tab. scored on 1 side and dependent tumours, hypertension, liver disorders, engraved with D 600 on each side of score. Other diabetes mellitus with or without vascular A side is engraved with Caltrate. 90, 7.84. involvement, cholelithiasis, migraine or severe S Correction of combined vit. D and Ca++ headache, systemic lupus erythematosus, history of deficiencies in the elderly. Supply of vit. D and endometrial hyperplasia, epilepsy, asthma, Ca++ as adjunct to specific treatments for otosclerosis. Discontinue if: Jaundice, BP increase, osteoporosis, in patients with diagnosed or at migraine onset. Calcium/vit. D suppl. Ca carb. 1.25g (equiv. to Ca++ 500mg), vit. D3 400 IU. White chewable tab. 100, A12.31. S Adjunct in oesteoporosis. P 2 daily preferably 1 morning and evening. Q Not applicable. ++
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
MENOPAUSAL DISORDERS,
B History of or current: Uterine fibroids, endometriosis, TE disorders, risk factors for oestrogen dependent tumours, hypertension, liver disorders, diabetes, cholelithiasis, migraine or (severe) headache, SLE, endometrial hyperplasia, epilepsy, asthma, otosclerosis. Cardiac or renal dysfunction, pre-existing hypertriglyceridemia. DIDRONEL PMO P & GP Withdraw if: Jaundice or deterioration in liver function, significant increase in BP, new onset of 2MO migraine-type headache. May increase risk of Bisphosphonate. Etidronate disodium 400mg and endometrial hyperplasia, carcinoma, breast cancer, Ca++ carb. 1250mg. 14 Didronel tabs (white cap. shaped tabs marked NE and 406) and 76 Cacit tabs VTE, ovarian cancer. Contact sensitisation may (pink, orange flavoured, efferv.) resp. 1 x 3 month occur. C CYP450 inducers, protease inhibitors, St. pack, A51.92; (A17.31 per month). John’s wort. S Treatment of osteoporosis and A Headache, migraine, GI disturbances. prevention of bone loss in post menopausal women considered at risk of developing Novartis osteoporosis. Patients who are unable or unwilling ESTRADOT 2NO to take oestrogen replacement therapy. Prevention and treatment of corticosteroid Oestrogen. Estradiol (as hemihydrate) 37.5mcg, induced osteoporosis. 50mcg, 75mcg, 100mcg per 24 hours. Transdermal P 1 Didronel 400mg tab. daily taken with patches. 37.5mcg/24 hours-8, A6.27; 50mcg/24 water in the middle of a 4 hour fast for 14 days, hours-8, A7.00; 75mcg/24 hours-8, A8.37; 100mcg/ followed by 1 Cacit tab. daily in water for 76 days. 24 hours-8, A8.37. Repeat 90 day cycle as required. S Hormone replacement therapy for Q Not recommended. oestrogen deficiency symptoms in postmenopausal D Severe renal impairment. women. Prevention of postmenopausal B Moderate renal impairment. osteoporosis in women with increased risk for Enterocolitis. Pregnancy, lactation. future osteoporotic fractures. A Nausea, diarrhoea. P Oestrogen deficiency symptoms: Initiate usually with 50mcg/24 hours every 3-4 days (twice DIVIGEL Orion weekly) adjusting to individual needs. Prevention of postmenopausal osteoporosis: Initiate with 2NO 50mcg/24 hours every 3-4 days (twice weekly), Oestrogen. Oestradiol 0.1%. Gel. Sachets-28 x 1g, adjust using 50, 75 and 100mcg strengths. A8.64. Q Not applicable. S HRT for climateric syndrome after natural or artificial menopause. Prevention of post D Oestrogen dependent tumours, undiagnosed vaginal bleeding, untreated menopausal osteoporosis. endometrial hyperplasia, thromboembolic P 0.5-1.5mg daily used cyclically or disorders, severe liver disease, porphyria. continuously. Normal starting dose 1mg daily. Pregnancy, lactation. See SPC. Apply once daily to the skin of lower trunk or thigh changing the application site daily (e.g. left B Migraine or severe headache, sudden hearing loss, liver disorders, history or risk of and right sides alternate days) If uterus is intact, also give a progestogen for 12 days of each cycle. thromboembolic disorders, leiomyoma, hypertension, diabetes mellitus with vascular D See SPC. Do not apply to breasts, face, involvement, cholelithiasis, systemic lupus irritated skin or vaginal area. erythematosus, hyperplasia of endometrium, DUPHASTON Solvay cardiac or renal dysfunction, asthma, epilepsy, familial hypertriglyceridaemia. 2NO Progestogen. Dydrogesterone 10mg. White scored C Substances known to induce drugmetabolising enzymes, specifically cytochrome tab. marked S and 155. 42, A8.16. P450 enzymes e.g. anticonvulsants (phenobarbital, S Adjunct to oppose oestrogen in HRT. phenytoin, carbamazepine), anti-infectives P 1 daily for last 14 days of each cycle. (rifampicin, rifabutin, nevirapine, efavirenz), Increasing if necessary to 1 twice daily. ritonavir, nelfinavir, St. John’s Wort. D See section 17.1. A Depression, headache, nervousness, ESTRADERM TTS Novartis mood changes, insomnia, nausea, dyspepsia, diarrhoea, abdominal pain, application site 2NO reactions, erythema, itching, breast tension and Oestrogen. Oestradiol 25 per 24 hours. pain, dysmenorrhoea, menstrual disorders, back Transdermal reservoir patches. 25mcg-8, A6.18. pain, asthenia, peripheral oedema, weight S Oestrogen replacement therapy for changes. hysterectomised patients with menopausal C Inducers of P450 enzymes, ritonavir, nelfinavir, St.John’s wort. A Pain, flatulence, nausea, oedema, weight gain, depression, dizziness, nervousness, lethargy, headache, sweating, pruritus, rash, menstrual disorder, vulva/ vagina disorder.
disorders. Prevention of postmenopausal osteoporosis in women considered to be at risk of developing fractures. P Apply patch to clean, non-hairy skin below waist and replace with new patch every 3-4 days using different site. Start with 50mcg patch, adjust dose after 1st month. Max. 100mcg daily. D Breast cancer, oestrogen dependent malignant tumours, vaginal bleeding, endometrial hyperplasia, venous thromboembolism, arterial thromboembolic disease, acute liver disease (or history), porphyria. Pregnancy.
OSTEOPOROSIS
17.5
increased to 2 daily, reducing to 1 daily as soon as practicable. Q Not applicable. D See SPC.
EVISTA
Daiichi Sankyo
5MO Selective oestrogen receptor modulator (SERM). Raloxifene (HCl) 60mg. White elliptical film-ctd tab. marked 4165. 28, A25.41; 84, A76.22. S Treatment and prevention of osteoporosis in post menopausal women. P 1 daily, for long-term use. Q Not applicable. D Women with child-bearing potential, lactation. Prolonged immobilisation or history of venous thromboembolic events, hepatic or severe renal impairment, undiagnosed vaginal bleeding, endometrial cancer. B Moderate and mild renal impairment. History of oral oestrogen-induced hypertriglyceridaemia. History of (or risk factors for) stroke. Safety in breast cancer not adequately studied. Ensure adequate Ca++ and vit. D intake. Contains lactose. C Systemic oestrogens, not recommended. Cholestyramine. A Hot flushes, leg cramps, flu-syndrome, peripheral oedema, venous thromboembolic events.
EVOREL
Janssen-Cilag
2NO
Oestrogen. Oestradiol 50mcg per 24 hours. Transdermal patch. 8, A8.37. S HRT for symptomatic relief of estrogen defiency. Osteoporosis prevention in postmenopausal women at high risk of fractures intolerant of, or contraindicated for, other medicines for osteoporosis prevention. P Apply patch to clean, non-hairy area of skin below waist and replace with new patch every 3-4 days using a different site. In nonhysterectomised patients give a progestogen for 12 days per month. See SPC. Q Not applicable. D Breast cancer, oestrogen dependent malignant tumours. Genital bleeding, untreated endometrial hyperplasia, thromboembolism, thrombophlebitis. Arterial thromboembolic disease, acute liver disease (or history). Severe renal disease, porphyria. Pregnancy, lactation. B Leiomyoma or endometriosis, thromboembolic disorders (history or risk factors for), risk factors for estrogen dependend tumours (e.g. 1st degree heredity for breast cancer),hypertension, kidney disorders, diabetes mellitus (with or without vascular involvement), cholelithiasis, migraine or severe headache, SLE, epilepsy, asthma, otosclerosis, mastopathy. Fluid retention: Observe in cardiac and renal dysfunction. Monitor patients with pre-existing hypertriglyceridemia. Immediate withdrawal: ESTROFEM Novo Nordisk Jaundice or worsening liver function, increase BP, 2NO new onset of migraine-type headache, pregnancy. Oestrogen. Estradiol 2mg. blue film-ctd tab. Not to be used for contraception. May increase marked NOVO 280. Blue film-ctd tab. marked risk of endometrial hyperplasia, breast cancer, VTE, NOVO 280. 28, A4.61. ovarian cancer. See SPC. S Oestrogen deficiency symptoms due to C CYP450 inducers, protease inhibitors, menopause or oophorectomy. Prevention of steroids, St. John’s wort, lamotrigine. osteoporosis. Women with a uterus, progestogen A Breast cancer, weight increase, must be considered. palpitations, nausea, rash, generalised and local P 1 daily without break in medication. If pain, breast pain, genital candidiasis, uterine clinical response is inadequate, dosage may be bleeding, application site erythema, irritation and
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
307
17.5 MENOPAUSAL
DISORDERS, OSTEOPOROSIS
OBSTETRICS AND
thromboembolism; active/recent arterial thromboembolic disease (e.g. angina, MI, CVA);
oedema.
EVOREL CONTI
Janssen-Cilag acute liver disease, or a history of liver disease
2NO Oestrogen/progestogen (continuous combined). Oestradiol hemihydrate 50mcg and norethisterone acetate 170mcg per 24 hours. Transdermal patch. 8, A17.00. S HRT for relief of postmenopausal symptoms in post-menopausal women q 6 months post-menopause. P Apply patch to clean, non-hairy area of skin below waist and replace with new patch every 3-4 days using a different site. Q Not applicable. D Breast cancer, oestrogen dependent malignant tumours. Genital bleeding, untreated endometrial hyperplasia, thromboembolism, thrombophlebitis. Arterial thromboembolic disease, acute liver disease (or history). Severe renal disease, porphyria. Pregnancy, lactation. B Leiomyoma or endometriosis, thromboembolic disorders (history or risk factors for), risk factors for estrogen dependend tumours (e.g. 1st degree heredity for breast cancer),hypertension, liver disorders (e.g. liver adenoma), kidney disorders, diabetes mellitus (with or without vascular involvement), cholelithiasis, migraine or severe headache, SLE, epilepsy, asthma, hereditary or idiopathic angioedema, otosclerosis, mastopathy. Fluid retention: Observe in cardiac and renal dysfunction. Monitor patients with terminal renal insufficiency, pre-existing hypertriglyceridemia. Immediate withdrawal: Jaundice or worsening liver function, increase BP, new onset of migrainetype headache, pregnancy. Not to be used for contraception. May increase risk of endometrial hyperplasia, breast cancer, VTE, ovarian cancer. See SPC. C CYP450 inducers, protease inhibitors, steroids, St. John’s wort, lamotrigine. A Weight increase, decreased libido, migraine, paraesthesia, hypertension, nausea, pruritus, general and local pain, breast pain, dysmenorrhoea incl lower abdominal pain, leukorrhoea, application site erythema/irritation/ oedema.
with abnormal liver function tests; porphyria. Pregnancy, lactation. B Leiomyoma, endometriosis, history of endometrial hyperplasia. Risk factors for thromboembolic disorders, estrogen dependent tumours. Hypertension, liver disorders, diabetes, cholelithiasis, severe headache, SLE, epilepsy, asthma, otosclerosis. C Cytochrome P450 inducers/inhibitors e.g. anticonvulsants (phenobarbital, phenytoin, carbamazepine), anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir, St John’s wort. A Headache, migraine, GI disorders, leg cramps, breast pain/tenderness, breakthrough bleeding, pelvic pain, asthenia, increase/decrease in weight.
GYNAECOLOGY
Q Not applicable. D See SPC.
FORSTEO
Lilly
2NT
Parathyroid hormone. Teriparatide 750mcg (equiv. 250mcg/ml); 20mcg/dose. Colourless clear sln for inj. in a 3ml pre-filled pen. 1, A454.58. S Osteoporosis in postmenopausal women and in men at increased risk of fracture (in postmenopausal women, demonstrated significant reduction of vertebral and non-vertebral fractures but not hip fractures). Osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. P 20mcg once daily by SC inj. in the thigh or abdomen for 24 months max.The 24-month course of FORSTEO should not be repeated over a patient’s lifetime. Q Not recommended. D Pregnancy, lactation. Pre-existing FEMOSTON 2/10 Solvay hypercalcaemia. Severe renal impairment. 2NO Metabolic bone diseases (incl. hyperparathyroidism, Paget’s disease of the bone) Oestrogen/progestogen (sequential combined). Oestradiol 2mg (14 brick-red tabs); oestradiol 2mg, other than primary osteoporosis or glucorticoidinduced osteoporosis. Unexplained elevations of dydrogesterone 10mg (14 yellow tabs). Round, alkaline phosphatase. Prior external beam or biconvex, film-ctd tabs. with 379 on one side and implant radiation therapy to skeleton. Skeletal S on reverse. 28, A5.39. malignancies or bone metastases. S Oestrogen deficiency symptoms in menopausal women. Prevention of osteoporosis in B Moderate renal impairment, active or recent urolithiasis. Any blood sampling should be postmenopausal women at high risk of future done at least 16 hrs after last Forsteo inj. fractures where other drugs are inappropriate. (elevations of serum Ca++). Limited experience in P 1 daily without break starting with brick-red tabs. Start by 5th day of menstruation if younger adult population (pre-menopausal women). Women of child-bearing age should use present or at any time if not. contraception. Potential transient orthostatic Q Under 18 years, not recommended. hypotension; refrain from driving. D Pregnancy, lactation. Current or past C Digitalis (caution). breast cancer, progesterone dependant A Palpitations, anaemia, GI disorders, limb neoplasma, estrogen-dependent malignant pain, muscle cramps, headache, dizziness, sciatica, tumours, undiagnosed genital bleeding, vertigo, dyspnoea, increased sweating, endometrial hyperplasia, previous idiopathic or current venous thromboembolism, active or recent hypercholesterolaemia, hypotension, fatigue, depression, inj. site reactions. arterial thromboembolic disease, acute or past liver disease as long as liver function tests still FOSALEN Pinewood abnormal, porphyria. 2MO B Conduct regular breast examinations. Caution: Leiomyoma or endometriosis, Bisphosphonate. Alendronic acid 70mg (as Na+ alendronate trihydrate). White to off-white, oval hypertension, liver disorders, diabetes mellitus, tab, embossed AN 70 on one side and logo on the cholelithiasis, migraine, systemic lupus FEMATAB Solvay erythematosus, history of endometrial hyperplasia, other. 4, A22.91. S Postmenopausal osteoporosis; also epilepsy, asthma, otosclerosis, cardiac or renal 2NO reduces risk of vertebral or hip fractures. dysfunction, hypertriglyceridemia, surgery. Oestrogen. Estradiol hemihydrate (equivalent to P 1 tab once weekly taken with plenty of Discontinue if: Jaundice or deterioration in liver estradiol) 1mg, 2mg. White or brick-red resp., water (not mineral water) at least 30 mins. before round, biconvex, film-ctd tab. marked with symbol function, significant increase in BP, new onset of 1st food/beverage or medicinal product of the on one side and 379 on the other. 1mg-28, A2.55; migraine. Contains lactose. day. Do not lie down until after 1st food which C Inducers of P450 enzymes 2mg-28, A2.59. should be at least 30 mins. after taking tab. (anticonvulsants, anti-infectives), ritonavir and S HRT for estrogen deficiency symptoms Q Not recommended. in menopausal women. Prevention of osteoporosis nelfinavir, St John’s wort. D For other prescribing information, see A Breakthrough bleeding or breast in postmenopausal women at high risk of future alendronate Drug Presc. Notes. changes, nausea, bloating, headache, leg cramps, fractures where other drugs are inappropriate. weight change, asthenia. P 1mg daily, taken continuously, FOSAMAX MSD depending on response can increase to 2mg daily. FEMOSTON-CONTI 1/5 Solvay 2 M O Women with a uterus, admin. progestagen for 122NO Bisphosphonate. Alendronate Na+ (equiv. 14 days each month. Women transferring from alendronic acid 10mg). White oval tab. marked Oestrogen/progesteogen (continuous combined). cyclic/continuous sequential HRT regimen, begin 936. 28 (Cal/Pk), A27.74. Oestradiol 1mg, dydrogesterone 5mg. Salmon treatment the day following completion of prior S Treatment of osteoporosis in postregimen. Start treatment within 5 days of the start film-ctd tab. marked with logo one side, 379 on menopausal women and in men. reverse. 28, A9.19. of menses. P 1 daily. Swallow tab. upon rising with S Symptoms due to oestrogen deficiency Q Not applicable. in post menopausal woman more than 12 months full glass of tap water, at least 30 mins. before D Non hysterectomized women without food, drink or other oral medication. Remain after menopause with a uterus. Prophylaxis of opposing progestogen, breast cancer, estrogenupright for 30 mins. after dose. postmenopausal osteoporosis in women with a dependent malignant tumours; undiagnosed Q Not recommended. uterus at risk of developing fractures. genital bleeding; untreated endometrial 2MO P 1 daily without break in medication. hyperplasia; previous idiopathic/current venous
308
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
ALSO FOSAMAX ONCE WEEKLY Alendronate Na+ trihydrate (equiv. alendronic acid 70mg). White oval tab. marked with an outline of a bone image one side, 31 on reverse. 4, A29.97. S Treatment of postmenopausal osteoporosis. Reduces the risk of vertebral and hip fractures. P One 70mg tab. once weekly. Swallow at least 30 mins. before first food, beverage, or medicinal product of the day with plain water only. Remain upright for 30 mins. after dose. Q Not recommended. D For other prescribing information, see alendronate Drug Presc. Notes. B Contains lactose.
MENOPAUSAL DISORDERS,
OSTEOPOROSIS
17.5
30 min after taking tab). Q Children and adolescents, not recommended. D For other prescribing information, see alendronate Drug Presc. Notes.
IDEOS
Helsinn Birex
2Y
Calcium/vit. D suppl. Ca++ carbonate 1.25g (equiv. Ca++ 500mg), vit. D3 400 IU. Lemon flavoured white square chewable tab. 60, A8.61. S Calcium/vit. D deficiency in elderly, adjunct in osteoporosis. P 1 twice a day. Q Not recommended. D Hypercalcaemia, hypercalciuria, Ca++ lithiasis, tissue calcification. Prolonged immobilisation. Vit. D overdose, myeloma and bone metastases, renal insufficiency. B Mild to moderate renal failure. FOSAVANCE MSD C Tetracyclines, vit. D, etidronate, cardiac 2MO glycosides, fluoride, thiazide diuretics. Bisphosphonate. Alendronic acid (as alendronate A Hypercalciuria, hypophosphataemia, Na+ trihydrate) / colecalciferol (vit. D3) 70mg/70mcg nausea, mild GI disturbance. (2800 IU), 70mg/140mcg (5600 IU). White tabs. marked with bone image on one side. 70mg/2800 INDIVINA Orion IU, cap.-shaped marked 710 on reverse. 70mg/5600 2 N O IU, modified rectangle-shaped marked 270 on Oestrogen/progestogen (continuous combined). reverse. 70mg/2800 IU-4, A29.44; 70mg/5600 IU-4, Oestradiol valerate 1mg, medroxyprogesterone A29.64. acetate 2.5mg white tab. marked 1+2.5; oestradiol S Postmenopausal osteoporosis in patients valerate 1mg; medroxyprogesterone acetate 5mg at risk of vit. D insufficiency; reduces the risk of white tab. marked 1+5; oestradiol valerate 2mg, vertebral and hip fractures. medroxyprogesterone acetate 5mg white tab. P 1 once weekly taken with plenty of marked 2+5. 1mg/2.5mg-1 x 28, A8.80; 1mg/5mg-3 water (not mineral water) at least 30 mins. before x 28, A26.39; 2mg/5mg-3 x 28, A26.39. 1st food/beverage or medicinal product of the S Replacement therapy for oestrogen day. Do not lie down until after 1st food which deficiency symptoms and prophylaxis of should be min. 30 mins. after taking tab. osteoporosis in women more than three years Q Children and adolescents, not after menopause with an intact uterus. recommended. P 1 tab. daily without a break between B Contains lactose and sucrose. For other packs. Initiate therapy with 1mg/2.5mg tab. prescribing information, see alendronate Drug Depending on clinical response to treatment the Presc. Notes. dosage can then be adjusted according to C Olestra, mineral oils, orlistat, bile acid individual needs. Change to 1mg/5mg if sequestrants, anticonvulsants, cimetidine, thiazides. breakthrough bleeding occurs; change to 2mg/
FOSTEPOR
Gerard
2MO Bisphosphonate. Alendronic acid 70mg (as alendronate Na+ trihydrate). White bi-convex tab., embossed AD70 on one side and G on reverse. 4, A22.93. S Postmenopausal osteoporosis. P 1 once weekly taken with plenty of water (not mineral water) at least 30 mins. before 1st food/beverage or medicinal product of the day. Do not lie down until after 1st food which should be min. 30 mins. after taking tab. Q Children and adolescents, not recommended. B Contains lactose. For other prescribing information, see alendronate Drug Presc. Notes.
5mg if oestrogen deficiency symptoms not adequately controlled. For maintenance therapy, lowest effective doses should be used. Q Not applicable D See SPC.
INTRINSA
P & GP
5O
Androgen. Testosterone 8.4mg (300mcg/24hrs). 8, A32.77. S Treatment of hypoactive sexual desire disorder in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant oestrogen therapy. P Apply one patch twice weekly to a clean, dry area of skin on lower abdomen below waist, rotating application site. Maximum one patch at a time. Evaluate treatment within 3-6 months of initiation. FOSTOLIN Actavis R Over 60 years, limited data. 2MO Q Not indicated. Bisphosphonate. Alendronic acid 70mg. Round, D Known, suspected or past history of white, biconvex tab. marked 70. 4, A19.50. breast cancer or oestrogen-dependent neoplasia, S Postmenopausal osteoporosis. Reduces or any condition where oestrogen use is risk of vertebral and hip fractures. contraindicated. Pregnancy, lactation. P 70mg once weekly, at least 30 min B Not recommended: Naturally before 1st food, beverage, or medicinal product of menopausal women, women on concomitant the day with plain water only (r 200ml). Do not conjugated equine oestrogens. Monitor for lie down until after 1st food of the day (at least potential androgenic undesirable effects; signs of AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
309
17.5 MENOPAUSAL
DISORDERS, OSTEOPOROSIS
OBSTETRICS AND
days of menstruation or withdrawal bleeding. Replace after 5 years. D Pregnancy, pelvic inflammatory disease, postpartum endometritis, infected miscarriage (past 3 months), cervicitis, cervical dysplasia, uterine or cervical malignancy, undiagnosed genital bleeding, uterine anomaly, genital infection, acute liver tumour, severe hepatic disease, progestogen-dependent tumours. B Severe arterial disease, migraine, exceptionally severe headache, jaundice, marked increase of BP, hormone dependent neoplasia incl. breast cancer, history of thromboembolism, may affect glucose tolerance. Lactation. C Caution: Liver enzyme inducing drugs. KLIOGEST Novo Nordisk A Weight gain, oedema, headache, lower abdominal pain, back pain, acne, vaginal 2NO discharge, cervicitis, dysmenorrhea, mastalgia, Oestrogen/progestogen (continuous combined). breast tension, depression, mood changes, nausea, Oestradiol 2mg, norethisterone acetate 1mg. expulsion. White tab. 28, A5.75. S Treatment of climacteric symptoms and NOVOFEM Novo Nordisk prevention of osteoporosis in post menopausal 2NO women. P One taken daily without interruption at Oestrogen/progestogen (sequential combined). the same time each day. Estradiol hemihydrate 1mg (16 red film-ctd tabs). Q Not applicable. Estradiol hemihydrate 1mg, norethisterone acetate D Porphyria. See SPC. 1mg (12 white film-ctd tabs). 3 x 28, A19.30. S HRT for oestrogen deficiency in post LIVIAL Schering-Plough menopausal women with an intact uterus. Prevention of postmenopausal osteoporosis in 5NO women with an incresed risk for future Gonadomimetic. Tibolone 2.5mg. White round tab. marked ORGANON one side, MK/2 on reverse. osteoporotic fractures. P 1 daily without a break between packs, 28, A15.14. taken in the following order: (red tabs.) over 16 S Oestrogen deficiency symptoms in days, followed by 12 days (white tabs). postmenopausal women, q1 year after Q Not applicable menopause. 2nd line therapy for prevention of D Breast cancer, oestrogen-dependent osteoporosis in postmenopausal women at high tumours, undiagnosed genital bleeding, active or risk of future fractures. P 1 daily swallowed with water preferably recent thromboembolic events, liver disease. Pregnancy. at same time each day. B Take personal and family history before D Pregnancy, lactation. Oestrogendependent tumours, current or past breast cancer, initiation of HRT, leiomyoma, endometriosis, hypertension, diabetes mellitus with vascular undiagnosed vaginal bleeding, endometrial hyperplasia, previous idiopathic or current venous involement, sudden hearing loss, migraine or severe headache. History of thromboembolism, thromboembolism, history of arterial thromboembolic disease (eg. angina, MI, stroke or hyperplasia of the endometrium, fibrocystic disease of the breast, history of liver disease. See TIA), liver disease, porphyria. SPC.. B Carefully assess risks of stroke, breast C See SPC and endometrial cancers. Caution: Leiomyoma, st A Breast tenderness, vaginal candidiasis, endometriosis, hypertension, 1 degree heredity for breast cancer, risk factors for thromboembolic dizziness, insomnia, depression, increased BP, dyspepsia, abdominal pain, nausea, rash, pruritus, disorders, hypertension, liver disorders, diabetes, cholelithiasis, migraine, SLE, history of endometrial vaginal haemorrhage, uterine fibroids aggrevated, oedema, weight increase. hyperplasia, epilepsy, asthma, otosclerosis. Discontinue if jaundice, new migraine onset, OSTEOFOS D3 A. Menarini significant BP increase, elective surgery followed by prolonged confinement. 2MO C Caution: Anticoagulants, midazolam, Calcium/vit. D suppl. Ca++ phos. 3100mg (equiv. other CYP3A4 substrates, certain antibiotics, antiCa++ 1200mg), cholecalciferol 20mcg (equiv. vit. D3 epileptic drugs or sedatives. 800 IU). Sachet, containing powder for oral susp. A Abnormal hair growth, endometrial wall 30 sachets, A9.53. thickening, postmenopausal/vaginal haemorrhage, S Correction of combined vit. D and breast tenderness, genital pruritus/discharge, calcium deficiency in elderly. As an adjunct to vaginal candidiasis, pelvic/ lower abdominal pain, specific treatment for osteoporosis. cervical dysplasia, vulvovaginitis. R 1 sachet daily. Q Not recommended. MIRENA Bayer Schering D Hypercalcaemia, hypercalciuria, severe 2NO renal insufficiency. Pregnancy, lactation. IUS. Levonorgestrel 52mg. T-shaped intrauterine B CVD. Sarcoidosis. A system. 1, 107.88. C Tetracycline, penicillin, neomycin, S Protection from endometrial hyperplasia chloramphenical, fluoride, bisphosphonates, during estrogen replacement therapy. thiazide diuretics, frusemide, ethacrynic acid, P To be inserted into the uterine cavity at cardiac glycosides. any time in amenorrheic women, or during last A Mild GI disturbances, hypercalcaemia.
virilisation may be irreversible, consider discontinuation. Discontinue if local hypersensitivity occurs. Little information available on long-term safety. Monitor for breast cancer. Caution: Cardiovascular risk factors, cardiovascular disease; monitor carefully (particularly changes in BP and weight). May decrease thyroxin-binding globulin levels. Pre-existing cardiac, renal, or hepatic disease: Oedema may occur (at doses higher than delivered by the patch). C Anticoagulants. A Insomnia, migraine, voice deepening, acne, alopecia, hirsutism, breast pain, increased weight.
310
GYNAECOLOGY
OSTEOMEL
Clonmel
2MO Bisphosphonate. Alendronic acid 70mg (as alendronate Na+ trihydrate). Oval, white tab., marked AN70 and logo on reverse. 4, A22.17. S Postmenopausal osteoporosis. P 1 once weekly taken with plenty of water (not mineral water) at least 30 mins. before 1st food/beverage or medicinal product of the day. Do not lie down until after 1st food which should be min. 30 mins. after taking tab. Q Children and adolescents, not recommended. B Contains lactose. For other prescribing information, see alendronate Drug Presc. Notes.
PREMARIN
Wyeth
2NO Oestrogen. Conjugated oestrogens 0.625mg maroon oval sug-ctd tab. 1.25mg yellow oval sugctd tab. Both either unmarked or marked PREMARIN. 0.625mg-28, A2.49; 1.25mg-28, A3.36. S Menopausal and post-menopausal oestrogen replacement in hysterectomised women; post-menopausal osteoporosis, atrophic vaginitis or urethritis. Palliation of selected cases of breast cancer. P Menopause, usually 0.625-1.25mg daily where continuous admin. is recommended. In nonhysterectomised women the addition of a progestogen 12-14days per cycle is essential. Q Not applicable. D See SPC.
PREMIQUE 5
Wyeth
2NO Oestrogen/progestogen (continuous combined). Conjugated oestrogens 0.625mg, medroxyprogesterone acetate 5mg. Blue oval sugctd tab. 28, A9.64. S Period-free HRT for menopausal symptoms and prevention of osteoporosis in post menopausal women with an intact uterus. P 1 daily without break starting on 1st day of cycle or at anytime if not menstruating regularly. Q Not applicable. D See SPC.
PREMPAK-C
Wyeth
2NO Oestrogen/progestogen (sequential combined). Conjugated oestrogens 0.625mg (28 maroon oval tabs.) or 1.25mg (28 yellow oval tabs.) norgestrel 0.15mg (12 brown tabs.). All sug-ctd tabs. 0.625mg-40, A4.73. 1.25mg-40, A4.73. S Menopausal and post-menopausal hormone replacement in women with an intact uterus, post menopausal osteoporosis, atrophic vaginitis or urethritis. D See SPC.
PREOTACT
Nycomed
2NT Parathyroid hormone. Parathyroid hormone 100mcg per dose. Powder and solvent for soln for inj. in cartridge (14 doses). 2, A415.29. S Osteoporosis in postmenopausal women at high risk of fractures (evidence for vertebral, not hip fractures). P 100mcg daily as SC injection into the abdomen. Duration, up to 24 months. Following treatment patients can be treated with a
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
AND GYNAECOLOGY
bisphosphonate to further increase bone mineral density. Q Under 18 years, not recommended. D Previous radiation therapy to the skeleton, pre-existing hypercalcemia and other disturbances in phosphocalcic metabolism, metabolic bone diseases other than primary osteoporosis, unexplained elevations of bonespecific alkaline phosphatase. Severe renal/severe hepatic impairment. B Monitor at months 1, 3 and 6 for elevated serum/urinary Ca++. Persistent above UNL, reduce frequency or discontinue. Supp. Ca++ and vit D if dietary intake inadequate. Active or previous urolithiasis (caution). Contains metacresol. Driving / using machines. C Caution: Cardiac glucosides. Alendronate (no additional benefit). A Hypercalcemia, hypercalciuria, nausea, GI disorders, headache, dizziness, palpitations, muscle cramp, pain, fatigue, inj. site reactions.
PROTELOS
Servier
2MO Dual Action Bone Agent (DABA). Strontium ranelate 2g. Granules for oral suspension. Sachets28, A39.21. S Postmenopausal osteoporosis to reduce risk of vertebral and hip fractures. P 2g once daily taken in water at bedtime, preferably at least 2 hours after eating. Q Children and adolescents, not recommended. D Pregnancy, lactation. B Severe renal impairment, not recommended. Chronic renal impairment, monitor renal function. Increased risk of venous thromboembolism (caution). Drug rash with eosinophilia and systemic symptoms (DRESS) (withdraw if occur). Interferes with colorimetric methods of Ca++ determination. Contains aspartame. C Products containing Ca++ (take 2 hours apart). Oral tetracycline or quinolone antibiotics (not recommended). Antacids (take q2 hours after Protelos). A Headache, GI disorders, dermatitis, eczema, transient increases in creatine kinase activity.
ROCALTROL
Roche
2MO Vit. D suppl. Calcitriol 0.25mcg. Caps. One half brown-red to orange-grey opaque, the other white to grey-yellow or grey-orange opaque. 0.25mcg-100, A22.73. S Postmenopausal osteoporosis. P 0.25mcg twice daily. Q Not recommended. D Metastatic calcification, hypercalcaemia. B Withhold other vit. D preps. Pregnancy. Monitor serum Ca++ levels regularly. A Hypercalcaemia, hypercalciuria.
ROMAX
Rowex
2MO Bisphosphonate. Alendronic acid 70mg (as alendronate Na+ trihydrate). Oval, white tab. embossed AN70 and arrow logo on reverse. 4, A21.58. S Postmenopausal osteoporosis. P 1 once weekly taken upon rising with full glass of water (not mineral water) min. 30 mins. before 1st food/beverage or medicinal
OBSTETRICS 17.6
product of the day. Do not lie down until after 1st food which should be min. 30 mins. after taking tab. Q Children and adolescents, not recommended. B Contains lactose. For other prescribing information, see alendronate Drug Presc. Notes.
or endometriosis, risk factors for thromboembolic disorders or for oestrogen dependent tumours, hypertension, liver disorders, diabetes mellitus, cholelithiasis, migraine, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis, cardiac or renal dysfunction, hypertriglyceridemia. Discontinue if: Jaundice or deterioration in liver function, SANDOCAL 400 Novartis Consumer significant increase in BP, new onset of migraine, pregnancy. 2 C Inducers of P450 enzymes such as Calcium suppl. Ca++ lactate gluconate 931mg, anticonvulsants and anti-infectives, ritonavir and calcium carbonate 700mg providing calcium 400mg (10 mmol), citric acid. White efferv. tab. 5 x nelfinavir, St John’s wort, ketoconazole. A Genital candidiasis or vaginitis, fluid 20, A10.30. retention, depression, headache, migraine, S Osteoporosis. abdominal pain or discomfort, nausea, back pain, P 3-5 daily. leg cramps, breast pain, breast oedema or Q Not applicable. enlargement, menstruation disorders, uterine D Severe hypercalcaemia, hypercalciuria fibroids, oedema peripheral, weight gain. (e.g. hyperparathyroidism, vit. D overdose, decalcifying tumours such as plasmocytoma and UTROGESTAN Besins skeletal metastases, immobilisation osteoporosis, 2N sarcoidosis), severe renal failure, milk-alkali syndrome, galactosaemia. Progestogen. Micronised progesterone 100mg. B Renal impairment, electrolyte White soft gelatin cap. 30, A6.05. imbalance. Monitor for nephrocalcinosis. Avoid vit. S Hormonal replacement therapy for the D. menopause. C Digoxin, cardiac glycosides, tetracyclines. P Usually 300mg daily as a single or in A Mild GI disturbances (constipation, divided doses for 10-14 consecutive days with diarrhoea). Symptoms indicating hypercalcaemia concurrent admin. of oestrogen during the last 10(nausea, vomiting, anorexia, constipation, 14 days of cycle. abdominal pain, bone pain, thirst, polyuria, muscle Q Not applicable. weakness, drowsiness, confusion). D History of thromboembolic disorders. Pregnancy. Mammary or genital carcinoma. Liver TEVANATE Teva dysfunction. Vascular disease. Undiagnosed abnormal vaginal bleeding. 2MO B Antibiotics, anti-epileptic drugs, Bisphosphonate. Alendronic acid 70mg (as sedatives. + alendronate Na monohydrate). White, flat-faced C Antibiotics, anti-epileptic drugs, bevel-edged round tablet, debossed with T on one sedatives. side. 4, A20.30. S Postmenopausal osteoporosis. VAGIFEM Novo Nordisk P 1 once weekly taken with plenty of water (not mineral water) at least 30 mins. before 2 N O 1st food/beverage or medicinal product of the Oestrogen. Oestradiol 0.025mg. White film-ctd day. Do not lie down until after 1st food which vaginal tab. marked NOVO 279. 3 x 5 applicators, should be min. 30 mins. after taking tab. A13.41. Q Children and adolescents, not S Atrophic vaginitis due to oestrogen recommended. deficiency. B For other prescribing information, see P Initially 1 daily for two weeks. alendronate Drug Presc. Notes. Maintenance, 1 twice weekly. Treatment should be limited to as short a time as possible. TRISEQUENS Novo Nordisk R Over 65 years, limited experience. 2NO Q Not applicable. D Porphyria, past or active breast cancer, Oestrogen/progestrogen. Estradiol 2mg (12 blue oestrogen-dependent malignant tumours (e.g. tabs.); estradiol 2mg, norethisterone acetate 1mg endometrial cancer), undiagnosed genital (10 white tabs.); estradiol 1mg (6 red tabs.). All bleeding, untreated endometrial hyperplasia, film-ctd, biconvex tabs. marked with NOVO 280, previous idiopathic or current venous 281 and 282 resp. 28, A4.59. thromboembolism. Pregnancy, lactation. S Oestrogen deficiency. Prevention of B Periodic check-ups (incl. pelvic and osteoporosis in postmenopausal women at high breast) recommended. See SPC. risk of future fractures where other drugs are C Caution: CYP 450 enzymes inducers. inappropriate. A Genital candidiasis or vaginitis, vaginal P 1 daily without interruption. discharge or bleeding, breast disorders, headache, Q Not applicable. D Known, past or suspected breast cancer, GI disorders, oedema. oestrogen-dependent malignant tumours, 17.6 OBSTETRICS undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or BRICANYL INJECTION AstraZeneca current venous thromboembolism, active or recent arterial thromboembolic disease (e.g. angina, MI), 5 N O Selective b2 -agonist. Terbutaline sulph. 0.5mg/ml. acute liver disease, or history of liver disease as long as liver function tests have failed to return to Amp. 5 x 1ml, A1.61. S Uncomplicated premature labour. normal, porphyria. Pregnancy, lactation. P 10-25mcg per minute by IV inf.; see SPC. B Periodic check-ups are recommended. Q Not applicable. Monitor changes in breasts. Caution: Leiomyoma
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
311
17.7 INFERTILITY
OBSTETRICS AND
B Monitor uterine activity, fetal status and progression of cervical dilation regularly. History of uterine hypertonic contractility or tetanic uterine contractions. Patients in whom oxytocic drugs are contraindicated or prolonged uterine contractions are undesirable. Glaucoma, increased IOP, asthma (or history of), questionably adequate cephalopelvic proportions. C Oxytocin. PABAL Ferring A Nausea, vomiting, diarrhoea, flushing, shivering, headaches. 2J Oxytocin agonist. Carbetocin 100mcg/ml. Clear SYNTOCINON Novartis colourless sln for inj. in amp. 1ml-5, A135.33. 2N S Prevention of uterine atony following delivery Caesarean section under epidural or spinal Uterotropic. Synthetic oxytocin 5 units/ml, 10 units/ anaesthesia. ml; amps. Soln for inf. or inj. 5 units/ml-5, A1.40; P 1ml by IV inj. Admin. only after delivery 10 units/ml-5, A1.61. by Caesarean section, asap after delivery, S Induction of labour in hypotonic uterine preferably before removal of placenta. For single inertia, during caesarean section, following use only, no further doses. delivery of the child. Prevention and treatment of D During pregnancy and labour before postpartum uterine atony and haemorrhage. As delivery of the infant (do not use to induce an adjunct for the management of incomplete or labour). Hepatic or renal disease. Pre-eclampsia, missed abortions. eclampsia. Serious cardiovascular disorders. P Induction of labour: IV inf. rate 1Epilepsy. 4milliunits/min increased if necessary at intervals B Not appropriate for use at any stage r20 min. Pregnancy near term: Inf. Q before delivery. If uterine bleeding persists, 10milliunits/min; max. rate 20milliunits/min. determine causes (e.g. retained placental Caesarean section: 5 IU by slow IV inj. immediately fragments, inadequate emptying or repair of the after delivery. Prevention of postpartum uterine uterus, or disorders of blood coagulation). haemorrhage: 5 IU slowly IV after delivery of Intended for single admin. only; if uterine placenta. Treatment of postpartum uterine hypotonia/atonia with consequent excessive haemorrhage: 5 IU slowly IV, severe cases followed bleeding persists, consider additional therapy with by IV inf. containing 5-20 IU oxytocin in 500ml oxytocin and/or ergometrine. Hyponatraemia may electrolyte containing diluent. Incomplete or occur. Caution: Migraine, asthma, cardiovascular missed abortion: 5 IU slowly IV followed by IV inf. disease or any state in which a rapid addition to rate 20-40milliunits/min or higher. extracellular water may produce hazard for an D Hypertonic uterine contractions, already overburdened system. mechanical obstruction to delivery, foetal distress. C Not recommended: Prostaglandins. Any condition where spontaneous labour is Caution: Vasoconstrictor in conjunction with inadvisable or vaginal delivery contraindicated. caudal-block anaesthesia. Inhalation anesthetics B Do not use for long periods in patients (e.g. halothane cyclopropane), ergot-alkaloids (e.g. with oxytocin resistant uterine inertia, severe premethylergometrine, oxytocin). eclamptic toxaemia or severe CVD. Excessive doses A Headache, tremor, hypotension, may cause foetal distress, asphyxia, or death. flushing, GI disorders, pruritus, feeling of warmth. Monitor foetal HR and uterine motility carefully. Anaemia, dizziness, chest pain, dyspnoea, metallic Caution: Borderline cephalopelvic disproportion, 2o taste, vomiting, back pain, chills, pain. uterine inertia, pregnancy-induced hypertension or CVD, patients q 35 yrs or a history of lower PROSTIN E2 Pfizer uterine segment caesarean section. Avoid rapid IV 2J bolus inj. Driving/operating machinery. Prostaglandin. Dinoprostone 0.5mg white C Prostaglandins, inhalation anaesthetics, rectangular tab. marked U 76. 10, A20.13. sympathomimetic vasoconstrictors. 2 A Headache, GI disturbances, tachycardia, bradycardia. ALSO PROSTIN E2 VAGINAL TABS. Dinoprostone 3mg white vag. tab. marked UPJOHN and 715. 8, SYNTOMETRINE Novartis A87.66.
D Antepartum haemorrhage; toxaemia of pregnancy; cord compression; threatened abortion; conditions where prolongation of pregnancy is hazardous. B Maternal thyrotoxicosis or CVD, diabetes. Monitor maternal and foetal heart rate. C b-blockers, other b-agonists. A Tachycardia, anxiety, rise in blood sugar.
2
2NO
ALSO PROSTIN E2 SOLUTIONS Dinoprostone 1mg/ ml. Clear, colourless alcoholic soln. in amps. 1mg/ ml (IV), A10.02. 10mg/ml, A21.64.
Uterotropic. Ergometrine maleate 0.5mg, synthetic oxytocin 5 units per ml; 1ml amp. 5, A1.11. S Prevention and control of post-partum haemorrhage. Active management of 3rd stage of labour. P 1ml by IM inj. Q Not applicable. D Severe kidney, liver or cardiac dysfunction, severe hypertension, pregnancy, obliterative vascular disease, sepsis. B Malnutrition, Raynaudâ&#x20AC;&#x2122;s disease. Mild to moderate hypertension, cardiac, liver or kidney disease. C Sympathomimetic amines, vasoconstrictors, prostaglandins, halothane. A Nausea, vomiting, abdominal pain, headache, dizziness, rash, hypertension,
2 ALSO PROSTIN E2 VAGINAL GEL Dinoprostone 1mg, 2mg per 3g; gel. 1mg-3g, A19.57; 2mg-3g, A21.56. S Induction of labour in the absence of fetal and maternal contraindications. P See SPC. D Previous Caesarean sections or major uterine surgery, major degrees of cephalopelvic disproportion, fetal malpresentation, pre-existing fetal distress, history of difficult or traumatic delivery, multiparae with over five previous term pregnancies, past history of, or existing, pelvic inflammatory disease.
312
GYNAECOLOGY
bradycardia, cardiac arrythmias, chest pain, anaphylactoid reactions.
TRACTOCILE
Ferring
2N Oxytocin antagonist. Atosiban (as acetate) 7.5mg/ ml; soln. in vial. Injection_0.9ml, A36.44; Infusion_5ml, A104.72. S To delay imminent pre-term birth in women with regular uterine contractions of at least 30 seconds duration at a rate equal or greater than 4/30 mins. with cervical dilation of 13 cm (0-3 cm for nulliparous) and effacement of 50% or more, a gestational age from 24 until 33 complete weeks, and a normal foetal heart rate. P Initially, a bolus dose of 6.75mg by i.v. inj. over 1 min. started as soon as possible after diagnosis of pre-term labour, immediately followed by a continuous high dose loading i.v. inf. of 300 microgram/min. over 3 hours, followed by a lower dose subsequent i.v. inf. of 100 microgram/min. for up to 45 hours. Max. duration of treatment 48 hours; max. total dose, 330mg. Discontinue if uterine contractions persist. Q Under 18 years, not recommended. D Gestation Q24 or q33 complete weeks. Premature rupture of the membranes over 30 weeks. Any conditions of the mother or foetus, in which continuation of pregnancy is hazardous. B Suspected premature rupture of membrane, abnormal placental site. Retreatment experience limited to three treatments. Monitor uterine contractions and foetal heart rate during treatment and for blood loss after delivery. A Nausea, headache, dizziness, vomiting, hot flushes, tachycardia, hypotension, hyperglycaemia, inj. site reactions.
17.7 INFERTILITY
BRAVELLE
Ferring
2N Gonadotropin. Urofollitropin 82.5 IU per vial. Powder and solvent for soln for inj. 10, A252.90. S Anovulation (incl. PCOD) in women unresponsive to clomiphene citrate. Controlled ovarian hyperstimulation to induce the development of multiple follicles for ART, GIFT and ICSI. P Anovulation: Start within initial 7 days of cycle. 75 IU daily by SC inj., increase at r 7 day intervals in increments of 37.5-75 IU. Max. daily R 225 IU. If no response after 4 weeks abandon that cycle. At optimal response admin. 5,000 -10,000 IU hCG by a single inj. 1 day following the last inj. Ovarian hyperstimulation: Start approx. 2 weeks after start of agonist treatment in protocols involving downregulation with GnRH agonists, or in protocols not involving downregulation, start on day 2-3 of cycle. 150-225 IU daily for at least 1st 5 days, increase by R 150 IU increments. Max. daily R 450 IU. Duration: Up to 12 days. At PRESCRIBING NOTES OBSTETRICS BETA AGONISTS. Terbutaline causes relaxation of uterine muscles and is used to inhibit premature labour. Oxytocin, ergometrine and prostaglandin, all induce uterine contraction and are used to induce abortion, induce or augment labour and minimise blood loss from the placental site following delivery. References available on request.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OBSTETRICS
INFERTILITY 17.7
AND GYNAECOLOGY
optimal response admin. 10,000 IU hCG by a single inj. 1 day following the last inj. D Tumours of the pituitary or hypothalamic glands. Ovarian, uterine or mammary carcinoma. Pregnancy, lactation. Gynaecological haemorrhage of unknown aetiology. Primary ovarian failure. Ovarian cysts or enlarged ovaries not due to polycystic ovarian disease. Malformation of sexual organs or fibroid tumours of the uterus incompatible with pregnancy. B Monitor ovarian response with ultrasound and serum oestradiol levels, regularly. Hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours. Risk of ovarian enlargement, Ovarian Hyperstimulation Syndrome (OHSS), multiple pregnancy. Personal or family history of thromboembolic events, severe obesity. C Clomiphene citrate may enhance follicular response. GnRH agonist (may increase dosage needed). A UTI, nasopharyngitis, headache, hot flushes, GI disorders, rash, muscle spasms, vaginal haemorrhage, OHSS, pelvic pain, breast tenderness, vaginal discharge, pain, inj. site pain and reactions.
(patients with history of seizures may be predisposed), nausea and vomiting, breast discomfort, headaches, intermenstrual spotting or menorrhagia, endometriosis, dermatitis and rash.
antibiotics, anti-psychotics. A Nausea, headache, dizziness, abdominal pain, fatigue, constipation, vomiting, breast pain, hot flushes, depression, paresthesia.
CRINONE
DUPHASTON
Merck Serono
Solvay
2NO
2NO
Progestogen. Progesterone 8%. Vaginal gel. 15, A51.39. S Infertility due to inadequate luteal phase. P 1 applicatorful daily starting after ovulation or on day 18-21 of cycle. Q Not applicable. D Undiagnosed vaginal bleeding. Known or suspected breast or genital organ malignancy. Acute porphyria, thromboembolic disorders and missed abortion. Lactation. B Undiagnosed vaginal bleeding (consider non-functional causes). C Other vaginal preparations. A Headache, somnolence, breast tenderness, intermenstrual bleeding (spotting), vaginal irritation and other mild application site reactions.
Progestogen. Dydrogesterone 10mg. White scored tab. marked S and 155. 42, A8.16. S Infertility due to inadequate luteal phase. P See SPC. D See section 17.1.
GONAL-F
Merck Serono
2N
Gonadotrophin. Follitropin alfa 75 IU (5.5mcg)/ml, 300 IU (22mcg)/0.5ml; 450 IU (33mcg)/0.75ml, 900 IU (66mcg)/1.5ml, 1050 IU (77mcg)/1.75ml. Single/ multidose vials or pre-filled pen. Single dose: 75 IU-1, A38.20; 5, A192.67. Multidose: 450 IU-1, A231.20; 1050 IU-1, A539.48. Pre-filled pen: 300 IU-1, A162.55; 450 IU-1, A243.83; 900 IU-1, A487.66. S Anovulation (incl. PCOD) in women unresponsive to treatment with clomiphene. DECAPEPTYL SR Ipsen Multifollicular stimulation in superovulation for 6 N T IVF, GIFT and ZIFT. Severe LH and FSH deficiency CETROTIDE Merck Serono (serum LH levelQ1.2 IU/l) in association with LH Gn-RH analogue. Triptorelin 3mg. 5ml vial 2N preparation. containing powder plus 2ml diluent. 1, A157.61. LH-RH antagonist. Cetrorelix (as acetate) 0.25mg, P Anovulation: Start within first 7 days of S Female infertility. 3mg. Powder in vials plus solvent in pre-filled cycle. 75-150 IU FSH daily SC, increased preferably P 1 vial (3mg) as single IM inj. Start on A A syringe. 0.25mg-1, 36.16; 7, 253.19; 3mg-1, by 37.5 IU, or 75 IU at 7 or preferably 14 day day 2 of cycle. Stimulation by gonadotrophins A253.19. intervals if necessary. Max. daily dose: 225 IU FSH. should be performed when the blood oestrogen S Prevention of premature ovulation in level is less than 50 pg/ml, which is usually around Superovulation: 150-225 IU, starting on days 2 or 3 controlled ovarian stimulation, followed by oocyte day 15 of cycle. See SPC. of cycle. Max.: 450 IU daily. Duration 5-20 days. LH pick-up and assisted reproductive techniques. and FSH deficiency: 75 IU of lutropin alfa daily Q Not applicable. P 0.25mg once daily by SC inj. into lower D Pregnancy. with 75-150 IU FSH, increased by 37.5 IU- 75 IU at abdominal wall given within 96-120 hours of 7-14 day intervals if necessary. All three indications: B See SPC. starting ovarian stimulation with gonadotrophins. A Hot flushes, headache, asthenia. At optimal response, admin. 5000 IU- 10000 IU Continue up to and incl. day of ovulation hCG by single inj. 24-48 hours after. Combined treatment with gonadotrophins may induction. Alternatively, a single 3mg SC inj. on D Pituitary or hypothalamus tumours. induce an ovarian hyperstimulation. See SPC. day 7 of ovarian stimulation. If ovulation is not Ovarian cyst or enlargement not associated with Pharmacia PCOD. Gynaecological haemorrhages of unknown possible on 5th day after inj., additionally 0.25mg DOSTINEX inj. once daily until day of ovulation induction. aetiology, ovarian, uterine or mammary 2NO Q Not applicable. carcinoma. Primary ovarian failure, malformations Dopamine agonist. Cabergoline 0.5mg. White of sexual organs or fibroid tumours of uterus D Moderate to severe renal or hepatic capsule shaped flat scored tabs. marked P and U incompatible with pregnancy. Pregnancy, impairment. Postmenopause. Pregnancy, lactation. on one face and 700 on the other. 8, A34.01. lactation. B Repeated cycles. Active allergic S Hyperprolactinaemic disorders incl. conditions. amenorrhoea, oligomenorrhoea, anovulation and B Hypothyroidism, adrenocortical deficiency, hyperprolactinemia. Monitor ovarian A Inj. site reactions, nausea, headache, galactorrhoea. Prolactin secreting pituitary response with ultrasound and oestradiol hypersensitivity reactions. adenomas, empty sella syndrome with associated measurements. Risk of ovarian enlargement, idiopathic hyperprolactinaemia and idiopathic CLOMID sanofi-aventis Ovarian Hyperstimulation Syndrome (OHSS), hyperprolactinoma. multiple pregnancy. Personal or family history of 5NO P Initially 1 tab. per week in one or two thrombo-embolic events. Antioestrogen. Clomiphene citrate 50mg. Beige doses. If necessary, increase gradually by 1 tab. per C Clomiphene citrate, hCG (may scored tab. marked M within two circles. 30, week at monthly intervals. Usual maintenance potentiate follicular response). GnRH agonist or A13.40. dose 2 tabs. per week in single or divided doses; S Ovulatory failure in women desiring max. 9 tabs. per week. Tabs. should be taken with antagonist (may increase dosage needed). A Ovarian cysts, inj. site reaction, pregnancy. food. headache, mild to moderate OHSS, abdominal P 1 tab. daily for 5 consecutive days, Q Not recommended. pain and GI symptoms. starting on fifth day of menstruation if possible. D Hypersensitivity to ergot alkaloids. Do not use for longer than 3 cycles in absence of Hepatic insufficiency, toxaemia of pregnancy. LUVERIS Merck Serono an ovulatory response. See SPC. Lactation. Do not co-administer with anti6N Q Not applicable. psychotics. Gonadotrophin. Lutropin alfa (recombinant D Pregnancy. Liver dysfunction. Ovarian B Evaluate pituitary prior to treatment. human LH) 75 IU. Powder and solvent for soln for dysgenesis. Menopause. Ovarian cyst. Abnormal Renal, hepatic or cardiac disease, Raynaud’s inj. in vial. 75 IU, A57.15. uterine bleeding. syndrome, GI ulceration or bleeding. Psychotic S In association with a FSH preparation B Ovarian Hyperstimulation Syndrome, disorders. Monitor gynaecological changes. for the stimulation of follicular development in visual symptoms, multiple pregnancy, ectopic Discontinue at least 1 month before trying to women with severe LH and FSH deficiency. pregnancy, uterine fibroids, birth anomalies, conceive. Use mechanical contraception if P 75 IU daily by SC inj. with 75-150 IU ovarian cancer. Contains lactose and sucrose. conception is not desired. See SPC. FSH. May be increased at 7-14 day intervals and A Ovarian enlargement, vasomotor C Long-term ergot alkaloids, dopamine preferably by 37.5 IU-75 IU increments. hCG flushes, abdominal/pelvic discomfort, convulsions agonists, dopamine antagonists, macrolide AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
313
17.7 INFERTILITY
OBSTETRICS AND haemorrhage of unknown aetiology, ovarian cysts or enlarged ovaries not due to POD. Primary ovarian failure, malformation of sexual organs / fibroid tumours of the uterus incompatible with pregnancy. Tumours of the testes, prostate carcinoma. B Before treatment evaluate for hypothyroidism, adrenocortical deficiency, hyperprolactinaemia, pituitary or hypothalamic tumours and treat accordingly. Monitor ovarian activity and oestrogen response to avoid hyperstimulation. In males, elevated gonadotrophin levels indicate primary testicular failure; do not usually respond to this therapy. Ovarian enlargement, hyperstimulation, Ovarian Hyperstimulation Syndrome (OHSS) may occur. Risk factors for thromboembolic events. Contains lactose. C Clomiphene citrate, GnRH agonist (adjust dose). A Nausea, abdominal/pelvic pain, enlarged Ferring abdomen, inj. site reaction/pain, headache, OHSS.
should be admin. 24-48 hours after last inj. D Ovarian, uterine, or mammary carcinoma, untreated tumours of hypothalamus and pituitary gland, ovarian enlargement or cyst not due to polycystic ovarian disease (PCOD), gynaecological haemorrhages of unknown origin. Conditions incompatible with pregnancy. B Hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours. Increased risk of hyperstimulation, ovarian hyperstimulation syndrome (OHSS), multiple pregnancies. Monitor ovarian response prior to and during therapy especially in patients with PCOD; ultrasound scans and oestradiol measurements are recommended. C Do not mix with other drugs, except follitropin alfa. A Inj. site reaction, headache, somnolence, nausea, abdominal pain, pelvic pain, OHSS, ovarian cyst, breast pain.
MENOPUR 6N
Gonadotropin Menotrophin (human menopausal gonadotrophin HMG), human follicle stimulating hormone (FSH) 75 IU, human luteinising hormone (LH) 75 IU 10, A232.50. S Anovulation, including polycystic ovarian disease (PCOD), if no response to clomiphene citrate; controlled ovarian hyperstimulation for assisted reproductive technologies (ART). Hypogonadotrophic hypogonadism in men. P Anovulatory infertility: Start within first 7 days of menstrual cycle. Initially, 75-150 IU daily for at least 7 days. Adjust with increments of 37.5 IU (max. 75 IU) with at least 7 day intervals. Max. daily dose, 225 IU. Abandon treatment course if no response in 4 weeks, and restart at higher starting dose. Optimal response, admin. hCG 500010000 IU 1 day after last Menopur inj. Superovulation: Start approx. 2 weeks after start of GnRH agonist or on day 2 or 3 of menstrual cycle if GnRH agonist not involved. Initially, 150225 IU daily for at least 5 days. Adjust with increments of max. 150 IU. Max. daily dose, 450 IU; max. recommended duration 20 days. Follow by single inj. of up to 10,000 IU hCG. Male infertility: Spermatogenesis stimulated with CG 1000-2000 IU 2-3 times a week and then Menopur dose of 75 or 150 units of FSH with 75 or 150 units of LH 2-3 times weekly. Continue for at least 3 or 4 months. R Not recommended. Q Not recommended. D Ovarian, uterine or mammary cancer. Tumours of pituitary gland or hypothalamus, pregnancy and lactation, gynaecological
CHANGE OF ADDRESS Doctors are requested to notify the publisher immediately of any change of address.Write to: Circulation Department, MIMS Ireland 24-26 Upper Ormond Quay, Dublin 7.
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314
GYNAECOLOGY
to moderate ovarian hyperstimulation syndrome.
PARLODEL
Meda
2MO Dopamine agonist. Bromocriptine (as mesylate) 2.5mg. White tab. scored and marked XC one side Sandoz on reverse. 30, A6.44; 100, A21.47.
2MO
ALSO PARLODEL CAPSULES Bromocriptine (as mesylate) 5mg. Blue/white cap. marked P5. 100, A41.84. S Endocrine-based infertility. P Initially, 1.25mg at bedtime. Titrate gradually at 2 to 3 day intervals to 7.5mg daily in divided doses with meals; max 30mg daily. Q Not applicable. D Hypersensitivity to ergot alkaloids. B Usage requires regular surveillance. History of peptic ulceration, psychotic or severe cardiovascular disorders. If pregnancy is undesired, use contraception, Perform regular gynaecological assessment for women receiving prolonged therapy. Observe patients on long term high doses ORGALUTRAN Schering-Plough for manifestations of retroperitoneal fibrosis. 2NO C Alcohol, erythromycin, psychoactive GnRH antagonist. Ganirelix 0.25ml/0.5ml. Sln for agents, drugs effecting BP. inj. 0.5ml syringe, A30.19. A Postural hypotension, nausea, vomiting, S Prevention of premature LH surges in mild constipation, dry mouth, leg cramps, rarely controlled ovarian hyperstimulation for assisted hypertension, MI, strokes, drowsiness, confusion, reproduction techniques (ART). hallucinations, headache, dizziness, seizures, P SC inj. once daily preferably in the episodes of reversible pallor of fingers and toes upper leg, starting on day 6 of FSH admin. See induced by cold, psychomotor exitation, SPC. dyskinesia, retroperitoneal fibeosis. D Hypersensitivity to GnRH or analogues. PERGOVERIS Merck Serono Moderate or severe renal or hepatic impairment. Pregnancy, lactation. 6N B Ovarian hyperstimulation syndrome may Gonadotrophins. Follitropin alfa (r-h FSH), 150IU occur. Severe allergic conditions (avoid), women (equiv. 11mcg) and lutropin alfa (r-h LH), 75IU Q50kg or q90kg (no data). (equiv. 3mcg). Powder and solvent for A Local skin reaction. subcutaneous injection. 1, A91.00; 10, A909.98. S Stimulation of follicular development in OVITRELLE Merck Serono women with severe LH and FSH deficiency. P Initially, one vial daily with additional 6N FSH if necessary. See SPC. Gonadotropin. Choriogonadotropin alfa 250mcg/ Q Not applicable. 0.5ml (equiv. 6500 IU). Soln. in pre-filled syringe. D Hypothalamus and pituitary gland 1, A43.88. S Superovulation in assisted reproductive tumours, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological techniques such as IVF. Anovulatory infertility. P Superovulation, 250mcg by SC inj. 24-48 haemorrhages, ovarian, uterine or mammary carcinoma or when an effective response cannot hours after last admin. of FSH or hMG. be obtained (e.g. primary ovarian failure, sexual Anovulation, 250mcg by SC inj. 24-48 hours after organs malformations or fibroid tumours of the optimal stimulation of follicular growth. uterus incompatible with pregnancy). Pregnancy, Q Not applicable. D Tumours of hypothalamus and pituitary lactation. gland, ovarian enlargement, or cyst due to reasons B Regularly monitor ovarian response with ultrasound alone or in combination with other than polycystic ovarian disease, serum oestradiol levels measurements to minimise gynaecological haemorrhages of unknown ovarian hyperstimulation syndrome (OHSS). hCG aetiology, ovarian, uterine or mammary carcinoma. Extra uterine pregnancy in the previous administration to induce ovulation increases OHSS risk. Porphyria (or family history): Closely monitor. 3 months, active thrombo-embolic disorders, Slightly higher prevalence of congenital primary ovarian failure. Malformations of sexual malformations in women with thrombo-embolic organs incompatible with pregnancy. Fibroid events risk factors. Ectopic pregnancies may occur. tumours of the uterus incompatible with Increased incidence of multiple pregancies and pregnancy, postmenopausal women. Pregnancy, births. lactation. A Ovarian cysts, mild to severe injection B Before treatment patients should be site reactions, headache, mild to moderate OHSS, evaluated for hypothyroidism, adrenocortical breast pain, pelvic pain, somnolence, abdominal deficiency, hyperprolactinemia, pituitary or hypothalamic tumours. Increase risk of developing pain and GI symptoms. ovarian hyperstimulation syndrome (OHSS). Schering-Plough Monitor oestradiol levels prior and during therapy. PREGNYL 6NO Risk of multiple pregnancy. Gonadotrophin. Human chorionic gonadotrophin A Local reactions/pain at inj. site. Headache, nausea, vomiting, abdominal pain, mild 5000 IU. Powder and solvent for soln. for inj. 1,
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
TOXICOLOGY
TOXICOLOGY 18.1
A3.91.
S Anovulatory sterility and secondary amenorrhoea (induce ovulation in ovary previously primed with FSH, and facilitate subsequent corpus luteum production). Controlled hyperstimulation regimens (prepare the follicles for harvesting). P Anovulatory Sterility and controlled hyperstimulation regimens: One IM or SC inj. 500010000 IU for 1 or 3 days in sequence to HMG. Up to 3 repeat inj. 5000 IU each may be given within the following 7 days to prevent insufficiency of corpus luteum. Q Not applicable. B Asthma, migraine, epilepsy, cardiac/renal dysfunction. Allergic diathesis. A Growth spurt (particularly if epiphyseal growth potentially active). Fluid retention. Ovarian enlargement or cysts, acute abdominal pain, super ovulation, multiple pregnancies.
PROVERA
Pharmacia
2NO Progestogen. Medroxyprogesterone acetate 2.5mg, 5mg, 10mg. Orange scored tab. marked U64, blue scored tab. marked 286 and white scored tab. marked UPJOHN 50. 2.5mg-30, A2.18; 5mg-30, A4.43; 5mg-100, A14.75; 10mg-90, A27.51. S Dysfunctional (anovulatory) uterine bleeding.Mild to moderate endometriosis.Secondary amenorrhoea. P Endometriosis: 10mg three times daily starting on the first day of cycle for 90 consecutive days. Dysfunctional uterine bleeding: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle and given for 2 consecutive cycles. Secondary amenorrhea: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle and repeated for 3 consecutive cycles. Q Not applicable. D History of thromboembolic disorders. Liver dysfunction, pregnancy. B History of depression, diabetes, epilepsy, migrane, asthma, cardiac or renal dysfunction. C Aminoglutethimide. A Thromboembolic disorders, insomnia, fatigue, rash, weight gain.
PUREGON
Schering-Plough
2NO Gonadotropin. Recombinant FSH 50 IU, 100 IU, 150 IU, 300 IU, 600 IU, 900 IU FSH activity. Soln for inj. in vials 0.5ml (50 IU-150 IU), or cartridges 0.36ml (300 IU), 0.72ml (600 IU), 1.08ml (900 IU). 50 IU-1, A26.55; 100 IU-1, A53.10; 150 IU-1, A79.65; 300 IU-1, A159.30; 600 IU-1, A318.60; 900 IU-1, A477.90. S Anovulary infertility (incl. PCOD) unresponsive to clomiphene citrate. Multifollicular stimulation in superovulation for IVF/ET/GIFT and ICSI. P Anovulation: Initially 50 IU daily for at least 7 days. Monitor response; see SPC. Superovulation: Initially 100-225 IU daily for at least 4 days, alone or in combination with a GnRH; See SPC. All by SC inj. (cartridges and vials) or SM inj. (vials). Q Not applicable. D Pregnancy, lactation. Tumours of pituitary, hypothalamus, ovary, breast or uterus. Fibroid tumours of uterus or malformation of sexual organs incompatible with pregnancy. Primary ovarian failure. Ovarian cyst or enlargement not related to PCOD. Undiagnosed vaginal bleeding.
B Women at risk for thrombosis. Exclude uncontrolled non-gonadal endocrinopathies. Ensure pregnancy is intrauterine (ultrasound examination). Monitor follicular development and oestradiol level to avoid hyperstimulation. C Clomiphene citrate (may enhance follicular response). GnRH agonist (increased dose of Puregon may be necessary). A Inj. site reactions. Ovarian hyperstimulation (discontinue). Multiple or ectopic pregnancies.
ANTABUSE
Actavis
2MO
Aldehyde. Disulfiram 400mg. White, flat, circular effervescent tab. 50, A22.26. S Adjunct in chronic alcoholism. To be used in conjunction with appropriate psychiatric treatment. P On 1st day 800mg in one dose. Then 600mg (2nd day), 400mg (3rd day), 200mg (4th and 5th day). Subsequently 200mg or 100mg daily or 23 times weekly until patient restored to social SUPRECUR sanofi-aventis order. An alcohol challenge may be performed from the fifth day of dosage onwards (see SPC). 6NO Q Not recommended. LH-RH analogue. Buserelin 150mcg (acetate) per D Decompensated cardiac disease, severe dose. Nasal spray. 2 x 10g with nebuliser type hypertension, psychoses. Pregnancy, lactation metered dose pump, A90.79. B Caution: Renal, hepatic or respiratory S Pituitary desensitisation in preparation disease, diabetes, mellitus, epilepsy, peripheral for ovulation induction regimes using neuropathy, hypothyroidism, irreversible brain gonadotrophins. damage. On no account drink alcohol (during P See data sheet. treatment and for 1 week after cessation), unless Q Not applicable. given as challenge dose by physician. Supportive D Post menopausal women, pregnancy, measures to counteract hypotension should be lactation. Undiagnosed vaginal bleeding, hormone available; a pressor agent (e.g. noradrenaline) may dependant neoplasms. be required. Driving/operating machinery. B Pregnancy test if there is a possibility of C Alcohol (admin. at least 24 hrs after last pregnancy. Impaired renal or liver function. ingestion). Caution: Paraldehyde, phenytoin, C Oral contraceptives. barbiturates, amphetamines, morphine, diazepam, A Menopause like symptoms and rifampicin, chlordiazepoxide, oral hypoglycaemics, withdrawal bleeding, bone mineral loss with courmarin anti-coagulants, metronidazole, prolonged use. Recovery of HPG function usually isoniazid, chlorpromazine, amitriphyline, pimozide. occurs within 8 weeks of discontinuing treatment. A Drowsiness, fatigue, headache, GI disorders, halitosis, taste disorders, reduced libido. SYNAREL NASAL SPRAY Pharmacia Elevations in liver enzyme levels (transaminases 6NT and S- GT) including icterus. GnRH analogue. Nafarelin (as acetate) 2mg/ml; Clear, colourless to slightly yellow nasal spray soln. CALMAX Ergha 200mcg per metered spray soln. 60 dose unit, 2NO A79.36. Medium-acting benzodiazepine. Alprazolam S Pituitary desensitisation in controlled 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm ovarian stimulation programmes prior to IVF. 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. P 1 spray (200mcg) to each nostril in the marked ’apzm 1’ resp. All tabs. oblong, scored. morning and evening until ovarian down0.25mg-100, A2.03. 0.5mg-100, A3.92. 1mg-100, regulation is achieved then administer A8.18. gonadotrophin; see data sheet. S Anxiety disorders. Q Not applicable. P 0.25-0.5mg three times daily. Max. 4mg D Discontinue at least 3 days before daily. embryos are placed in utero. Lactation. R 0.25mg two or three times daily. Undiagnosed vaginal bleeding. Q Not recommended. B Patients at risk of osteoporosis. D See SPC. A Hot flushes, vaginal dryness, headache, changes in libido, emotional lability, myalgia, CAMPRAL EC Merck Serono decreased breast size, irritation of nasal mucosa, 2MO small reduction in bone density. ++ GABA analogue. Acamprosate (Ca ) 333mg. White ent-ctd tab. marked 333. 84, A27.57. 18.1 TOXICOLOGY S Adjunct to counselling to maintain ANEXATE Roche abstinence in alcohol-dependent patients. P Over 60kg, 2 three times daily with 2N meals; under 60kg, 2 in the morning, 1 at noon Benzodiazepine antagonist. Flumazenil 100mcg/ml. and 1 at night with meals. Commence treatment Amp. 5 x 5ml, A111.33. as soon as possible after alcohol withdrawal and S Reversal of the central sedative effects maintain for 1 year. of benzodiazepines. W Not recommended. P 200mcg IV over 15 sec, with repeat D Renal insufficuency, severe hepatic doses of 100mcg until desired level of failure. Pregnancy, lactation. consciousness is obtained; max 1mg or 2mg in B Not a treatment for withdrawal period. intensive care setting. As an infusion of 100Initiation only under direct supervision of 400mcg/hour adjusting rate to achieve desired consultant or clinician experienced in the field, in level of arousal. a hospital clinic or alcohol treatment unit. GPs B Tricyclic antidepressants, epileptic with interest in treating alcohol dependent patients receiving benzodiazepine treatment for patients are permitted to initiate or pursue prolonged periods. Pregnancy. Campral treatment. Monitor for symptoms of A Nausea, vomiting, flushing, rarely suicidality. A GI disturbances, skin reactions, seizures, transient increase in BP.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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18.1 TOXICOLOGY
TOXICOLOGY levels of CYP1A2 substrates. Significant depressive symptoms may occur.History of psychiatric illness. Epilepsy. Discontinuation: May require dose tapering. Lactation. Driving or using machinery. A Nausea, increased appetite, abnormal dreams, insomnia, headache, somnolence, dizziness, dysgeusia, GI disorders, fatigue.
in high doses. Perform regular ophthalmological and audiological tests prior to treatment and at 3 monthly intervals during treatment. Pregnancy, lactation. Perform eye tests during long-term therapy. C Vitamin C, prochlorperazine, erythropoietin. CHAMPIX Pfizer A Shock with rapid IV inj. Rarely allergic 2NO DESFERAL Novartis reactions, Cardiovascular, neurological and Gl disturbances. Red colouration of urine. Lens and Partial agonist. Varenicline (as tartrate) 0.5mg, 2NO retinal changes. Hepatic and renal dysfunction. 1mg. White and light blue resp. capsular-shaped, (mesylate) Blood dyscrasias. Hearing disturbances. biconvex film-ctd tab. debossed with Pfizer on one Chelating agent. Desferrioxamine A36.48. 500mg. Powder in vial. 10, side and CHX 0.5 or CHX 1.0 on reverse. 4 week S Aluminium overload: patients under A DISTAMINE Alliance starter pack: 0.5mg -11 and 1mg -42, 70.56. 4 maintenance dialysis for end stage renal failure week, 0.5mg-56, A73.25. 4 week, 1mg 2MO with aluminium-related bone disease and/or continuation pack: 1mg x 56, A72.79. Chelating agent. Penicillamine base 125mg, anaemia, dialysis encephalopathy, diagnosis of S Smoking cessation in adults. 250mg. White film-ctd tab. marked DS and 125 or P 1mg, twice daily, swallowed whole with aluminium overload. Iron overload: acute iron DM and 250. 125mg-100, A12.44; 250mg-100, poisoning, primary and secondary water. Titrated as follows: Days 1-3, 0.5mg once A21.45. haemochromatosis incl. thalassaemia and daily; days 4-7, 0.5mg twice daily and day 8 S Cystinuria, Wilsonâ&#x20AC;&#x2122;s disease, heavy metal onwards, 1mg twice daily. Begin 1-2 weeks before transfusional haemosiderosis, in patients in whom poisoning, chronic active hepatitis. concomitant disorders (e.g. severe anaemia, desired quit date. If adverse effects not tolerated V See SPC. hypoproteinaemia, renal failure) preclude dose may be lowered to 0.5 mg twice daily. phlebotomy. Treatment of corneal rust stains and D Agranulocytosis or severe Duration: 12 weeks; if successful consider thrombocytopenia due to penicillamine. Lupus ocular siderosis. Diagnosis of iron storage disease, additional 12 week course at 1mg twice daily. erythematosus. Lactation. Persistent proteinuria. certain anaemias. Renal impairment: Moderate, dose may be Moderate/ severe renal impairment. Pregnancy. reduced to 1mg once daily; severe, 1mg once daily V See lit. B Renal insufficiency. Monitor blood, B Impaired renal function. Neurological (0.5 mg once daily for the first 3 days then, 1 mg urine and renal function before and frequently dysfunction in patients with aluminium-related once daily). during treatment. Consider withdrawal if platelets encephalopathy occurs when used alone; avoid Q Not recommended. fall Q 120,000 or white blood cells Q 2,500/mm3, with pretreatment with clonazepam. Local D Pregnancy. or if 3 successive falls noted within the normal B Smoking cessation may increase plasma irritations may occur more frequently if given SC range. Use antihistamines, steroid cover, or impotence, altered libido.
PRESCRIBING NOTES TOXICOLOGY It should be recognised that treatment of poisoning should be conducted under hospital supervision and following advice from a Poisons Information Centre. Petroleum products and essential oils. These are more dangerous to the lungs, so emesis is contraindicated following ingestion due to the risk of aspiration. Corrosive substances. Due to their effect on the oesophagus, emesis is again contraindicated to avoid further damage to this area. If possible getting the patient to drink water or milk as soon as possible after the event may aid dilution. Heavy metal poisoning. The chelating agents penicillamine, dimercaprol and sodium calcium edetate are recommended. Drugs and poisons. Activated charcoal is very effective at binding to various drugs and poisons in the stomach and consequently reducing their absorption into the systemic circulation. Repeated doses of activated charcoal are used to enhance the elimination of some drugs following absorption. Opioids. The specific antidote is naloxone. It has a shorter duration of action than many of the opioids and consequently subsequent doses may be required or the use of a continuous infusion which can be adjusted according to response. Treatment of dependence should only be conducted in specialist centres where treatment with methadone can be monitored. Paracetamol. As little as 10-15g of paracetamol is required to cause severe liver damage, which means that the poisoning produces minimal symptoms. The recommended treatments are methionine or acetylcysteine, the latter being effective if given up to and possibly beyond 24 hours after ingestion. Organophosphates and carbamates. Atropine is used to reverse the muscarinic effects of the poisoning. Pralidoxime mesilate is indicated as an adjuvant to atropine in organophosphate poisoning. It is a cholinesterase reactivator, but it is only effective if administered within the first 24 hours following ingestion. Pralidoxime is contra-indicated in carbamate poisoning. Heparin. Protamine sulphate is indicated as a specific antidote. Iron. Adverse effects can be reduced by using desferrioxamine, which acts by chelating iron. It is given intravenously to chelate iron that has been absorbed systemically. Gastric lavage should be used to empty the stomach of any unabsorbed iron that may still be present. Alcohol. Abuse can be treated with disulfiram which will produce an unpleasant reaction to further ingestion of alcohol. Treatment of withdrawal symptoms in patients trying to overcome dependence can be eased using benzodiazepine, alprazolam. Nicotine. Withdrawal can be eased using a number of nicotine replacement preparations ranging from chewing gum to patches and nasal sprays. They attempt to break the psychological habit by assisting with the unpleasant withdrawal effects of the physical addiction. Contact: The National Poisons Information Centre, Beaumont Hospital, Dublin 9. Telephone: (01) 8379964 or (01) 8379966 References available on request.
316
temporary reduction of dose to control urticarial reactions. Reversible loss of taste may occur. Stop treatment immediately if haematuria occurs in the absence of renal stones or other known cause. A late rash may occur after several months or years of therapy (dose may need to be reduced). Breast enlargement may occur in men and women. Deterioration of Wilsonâ&#x20AC;&#x2122;s disease neurological symptoms (dystonia, rigidity, tremor, dysarthria) reported. C Gold salts, anti-inflammatory, oral iron, drugs known to cause bone marrow or renal injury. A Thrombocytopenia, proteinuria.
NALOREX
BMS
2NO Narcotic antagonist. Naltrexone (HCl) 50mg. Yellow film-ctd scored tab. marked R11 on one side and 50 on reverse. 28 (Cal/Pk), A63.45. S Maintenance therapy in detoxified, formerly opioid-dependent patients. P Initially 25mg, then 50mg daily. Initial treatment in drug addiction centre and a treatment period of three months should be considered. Q Under 18 years, not recommended. D Acute hepatitis or liver failure; dependence to opioids; acute opoid withdrawal; in conjunction with an opioid-containing medication; positive screening for opioids or failure of the Narcan Challenge. B Renal or hepatic impairment. Ability to drive or operate machinery may be impaired. Pregnancy, lactation. A Chest pain, abdominal pain/cramps, GI disturbances, joint and muscle pain, delayed ejaculation, decreased potency, skin rash, difficulty sleeping, anxiety, nervousness, headache, feeling down, irritability, dizziness, increased lacrimation, loss of appetite, increased thirst, increased energy, chills, increased sweating.
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
18.1 TOXICOLOGY
TOXICOLOGY
withdrawal symptoms, facilitating cessation in smokers motivated to quit or helping smokers temporarily abstain from smoking. Narcotic antagonist. Naloxone hydroclor. 400mcg/ P 20 or more cigarettes daily, use 4mg ml; Soln for inj. in a glass vial. 1, A9.02; 5, A24.51; gum. Otherwise 2mg gum is sufficient. Use at 10, A51.66. regular intervals to prevent craving occurring. 2N Chew slowly then rest to allow nicotine to be ALSO NALOXONE PAEDIATRIC Naloxone (HCl) 40 absorbed. Max. 15 pieces daily. May be used for up to 3 months. mcg/ml; Soln. for inj. in a glass vial. 5, A20.81. S Reversal of opioid depression, incl. that 2 O due to nalbuphine and pentazocine. Diagnosis of ALSO NICORETTE INHALER Nicotine 10mg. acute opioid overdosage. Inhalation cartridge plus mouthpiece. 18, A9.32; P Postoperatively: 100-200mcg IV at 2-3 42, A16.34. min intervals. Additional doses may be necessary P Cessation: 3 month course. 6-12 at 1-2 hr intervals. Opioid overdosage: 400cartridges daily for 8 weeks, followed by gradual 2,000mcg IV at 2-3 min intervals. May admin. IM reduction to zero cartridges at 12 weeks. or SC if IV route cannot be used. Abstinence: Max. 12 cartridges in 24 hours. Q Initially 10mcg/kg body weight IV; max. 2 O 100mcg/kg body weight. May admin. IM or SC if ALSO NICORETTE MICROTAB Nicotine 2mg. IV route is unavailable. Opioid depression: 10mcg/ Sublingual tab. 30 (OTC), A7.21; 105, A14.93. kg body weight IV, IM or SC inj. repeated at 2-3 P Cessation: 1-2 tabs. per hour placed min intervals. Single IM dose of 60mcg/kg may be under the tongue; max. 40 tabs daily. Use for 3 given at birth. months while gradually reducing dosage. Stop D Pregnancy, lactation. treatment when only 1-2 tabs. are taken each day. B Opioid dependent patients, or patients Abstinence, 1-2 tabs per hour. who have received large doses of opioids. Avoid 2O excessive dosage following surgery. CVD, ALSO NICORETTE INVISIPATCH Nicotine 10mg, cardiotoxic drugs, elderly. Ineffective against non- 15mg, 25mg per 16 hours. Transdermal patches. opioid induced respiratory depression. Monitor 10mg-7, A10.77; 15mg-7, A10.77; 25mg-7, carefully. A10.77. A GI disturbances, sweating, tachycardia, S Relief of nicotine craving and fibrillation, hyperventilation, hypo/hypertension, withdrawal symptoms, facilitating cessation in tremulousness, pulmonary oedema. smokers motivated to quit. P Apply 1 patch once daily on waking and NICOPASS Clonmel removed at bedtime. Heavy smokers: Initially use 2 25mg patch for 8 weeks, then 15mg patch for 2 weeks, followed by 10mg patch for 2 weeks. Light Alkaloid. Nicotine 1.5mg equiv. 8.33mg nicotine smokers: Start with 15mg patch for 8 weeks and resinate. Opaque, square lozenge. Beige decrease to 10mg for final 4 weeks. (freshmint) or brown (liquorice mint). 12, A2.61; Q Under 18 years, not recommended 36, A6.92. S Relief of nicotine withdrawal symptoms, without physician’s advice. D Non-smokers. Pregnancy (except on in nicotine dependency as an aid to smoking doctors advise), lactation. cessation. P 8-12 daily for about 3 months (max. 20 B CVD, uncontrolled hypertension, severe/ moderate hepatic impairment, severe renal daily), reducing gradually down to 1-2 daily then impairment, active and duodenal ulcers, stop. Max: 6 months. hyperthyroidism or pheochromocytoma. Diabetes D Non-smoker or occasional smoker. mellitus (lower dose of insulin may be required). Hypersensitivity to peanut or soya. C Smoking cessation may alter B Recent MI, unstable or worsening pharmacokinetics of certain drugs. angina incl. Prinzmetal’s angina, severe cardiac arrhythmias, uncontrolled hypertensions or recent A Local irritation, headache, dizziness, GI discomfort. Itching, erythma (patch). cerebrovascular accident (close medical supervision). Caution: Stable CVD, diabetes NICOTINELL Novartis Consumer mellitus, hyperthyroidism or phaeochromocytoma, severe hepatic / renal impairment. Active 2O oesophagitis, oral or pharyngeal inflammation, Alkaloid. Nicotinell TTS10, TTS20, TTS30 providing gastritis or peptic ulcer. Contains aspartame and 7mg, 14mg and 21mg nicotine per 24 hours. isomalt. Pregnancy, lactation (avoid). Transdermal patch. TTS10-7, A10.54; TTS20-7, C Tobacco cessation: CYP1A2 substrates A11.01; TTS30-7, A11.48; 21, A27.64. incl. caffeine, theophylline. Nicotine: Nifedipine, b- S Nicotine dependency as an aid to blockers, insulin, diuretics, H2 antihistamines, smoking cessation. oestrogen-progestagen combinations. P Subject should be advised to stop A Slight irritation of the throat, salivation, smoking completely when starting treatment. hiccup, dizziness, headache, GI disorders. More than 20 cigarettes per day, initially 21mg/24 hour patch once daily; less than 20 cigarettes per NICORETTE McNeil Healthcare day, initially 14mg/24 hour patch once daily. 2 Reduce dose at intervals of 3-4 weeks. Max. treatment period 3 months. Apply patch to non NICORETTE GUM. Alkaloid. Nicotine 2mg, 4mg. hairy area of skin on trunk or upper arm. Do not Chewing gum. Classic/ mint/ freshmint/ freshfruit: A A A 2mg-30, 5.75; 105, 17.98; 4mg-30, 7.18; 105, remove at night. 2O A22.01. Also: Classic: 2mg-210, A24.91 (GMS); 4mg-210, A30.74 (GMS). Mint: 2mg-210, A29.31; ALSO NICOTINELL GUM Nicotine 2mg, 4mg. Mint 4mg-210, A36.16. or fruit flavoured chewing gum. 2mg-24, A3.34; 96, A10.74. 4mg-24, A3.68; 96, A13.32. S Relief of nicotine craving and
NALOXONE
Antigen
2N
318
P Use 2mg gum if Q20 cigarettes a day and 4mg gum if q 30 cigarettes a day; either in between. Chew each piece for 30 mins. when urge to smoke; max. 25 x 2mg or 15 x 4mg pieces daily. Stop smoking completely. Withdraw gradually after 3 months.
2O ALSO NICOTINELL MINT LOZENGES Nicotine 1mg, 2mg. Mint flavoured compressed lozenge. 1mg-36, A5.55; 96, A11.79. 2mg (non GMS yet)-36, A7.60; 96, A16.13. P Use 1mg lozenge if Q20 cigarettes a day or 2mg if q 30 cigarettes a day; either in between. Suck 1 lozenge over 30 minutes every 12 hours when urge to smoke. Usual dose 8-12 lozenges per day, max. 30mg a day. Reduce gradually after 3 months. Q Under 18 years, not recommended without physician’s advice. D Non smokers. Patch only: Acute MI, unstable angina, severe cardiac arrhythmias, recent stroke, skin disease. B Hypertension, angina, cerebrovascular or occlusive peripheral vascular disease, HF, diabetes mellitus, hyperthyroidism, pheochromocytoma, renal/hepatic impairment, peptic ulcer. Oral: MI, severe cardiac arrhythmias, stroke, fructose intolerance, oesophagitis, gastritis. Oral nicotine replacement beyond 6 months, not recommended; beyond 9 months, seek medical advice. Lozenges contain aspartame. Gums contain sweeteners, incl. sorbitol. C Caution: Propoxyphene, furosemide, propranolol, nifedipine, adrenergics, H2 antagonists. Smoking cessation decreases CYP1A2 activity. A Headache, dizziness, GI disorders, dry mouth. Jaw muscle ache (gum). Local skin reactions (patch).
NIQUITIN CQ
GSK
2O Alkaloid. Nicotine 21mg, 14mg, 7mg per 24 hrs. Transdermal patches. 21mg-1 week kit, A11.86; 2 week kit, A21.38; 14mg-1 week kit, A11.86; 7mg1 week kit, A11.86. S Relief of nicotine withdrawal symptoms incl. craving associated with smoking cessation. Should be used with the CQ behavioural support programme which is available free. P Users should stop smoking completely during a cessation attempt. No other form of nicotine should be taken at the same time. More than 10 cigarettes, initially 21mg/24 hrs patch once daily for 6 weeks. Reduce dose to 14mg/24 hrs for 2 weeks followed by 7mg/24 hrs for last two weeks. Those who smoke Q 10 cigarettes per day start with 14mg/24 hrs for 6 weeks followed by 7mg/24 hrs for final two weeks. Max treatment period 10 consecutive weeks. Patches may be removed before going to bed. However use for 24 hrs is recommended. Q Not recommended.
2O ALSO NIQUITIN CQ MINT LOZENGE Nicotine 2mg, 4mg. White lozenges marked NL2 or NL4. 2mg-36, A9.01; 72, A14.73; 4mg-36, A9.01; 72, A14.73. P Users must stop smoking completely. 2mg lozenge s are suitable for those who smoke 30+ mins. after waking and 4mg lozenges are suitable or those who smoke within 30 mins. of waking. 3 step tereatment. Step 1 (weeks 1-6) start with 1 every 1-2 hours. Step 2 (weeks7-9) 1 every 2-4 hours. Step 3 (weeks 10-12) 1 every 4-8
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
TOXICOLOGY
TOXICOLOGY 18.1
interval prolongation and serious arrhythmia (particularly at high doses; caution and careful monitoring of patients at risk of prolonged QT interval, known history, advanced heart disease, ischaemic heart and liver disease, concomitant drugs that prolong QT interval), morphine type dependence. Caution: Hypothyroidism, adrenocortical insufficiency, hypopituitarism, prostatic hypertrophy, shock, phaeochromocytoma (particularly in association with diamorphine). Pregnancy, lactation. C Contra: MAOIs (or within 14 days of stopping). Caution: Rifampicin, phenytoin, carbamazepine, St John’s Wort, antiretrovirals (e.g. nevirapine, efavirenz, some protease inhibitors), fluconazole, some SSRIs (particularly fluvoxamine), CYP3A4 inhibitors, drugs known to have potential for QT interval prolongation, class I and III antiarrhythmics, some neuroleptics, TCAs, Ca++ channel blockers, diuretics, laxatives, mineralocorticoid hormones, nelfinavir, PARVOLEX UCB zidovudine, fluconazole, desipramine, other centrally-acting agents (alcohol, barbiturates, 2N neuromuscular blocking agents, phenothiazines Paracetamol antidote. Acetylcysteine 200mg/ml. and tranquillisers, some psychotropic drugs). Amps. containing clear colourless soln. for inf. A Confusion, dizziness, drowsiness, light10ml x 10, A36.10. headedness, GI disorders, sweating, urinary S Treatment of paracetamol overdose. retention/hesitancy. P Admin. by IV inf. Initially, 150mg/kg body weight infused in 200ml over 15 mins. PINADONE DTF Pinewood Followed by, 50mg/kg infused in 500ml over next 4 hrs. Then, 100mg/kg in 1L over next 16 hrs. Total: 0 L Opiate. Methadone (HCl) 1mg/ml; sugar-free 300mg/kg in 20hrs. liquid. 500ml, A12.70. R r20kg: Initially, 150mg/kg in 100ml over 15 mins. Followed by, 50mg/kg in 250ml over S Opioid addiction as substitution or 4 hrs. Then 100mg/kg in 500ml over 16 hrs. Under maintenance therapy, within a broader treatment 20kg: Infusion volumes responsibility of prescriber. protocol/programme accompanied by regular reviews and reassessment. D Pregnancy (assess risk/benefit). B Asthma, history of bronchospasm. Liver P Initially 10-20mg daily, increasing by 1020mg daily until there are no signs of withdrawal enzyme inducing drugs, chronic alcohol abuse or intoxication. Usually 40-60mg daily. See (consult treatment normogram). SPC.Treatment must be supervised by specialist A Anaphylactoid, hypersensitivity-like services. reactions. Q Not recommended. PHYMET DTF GSK D Respiratory disease, obstructive airways disease. Obstetrics. 0L B Pregnancy. Impaired liver or kidney Opiate. Methadone HCl, 1mg/ml. Clear green function. viscous oral solution. C MAOIs, CNS depressants. S Opioid drug addictions (as narcotic A Nausea, vomiting, constipation, abstinence syndrome suppressant), as substitution drowsiness, blurred vision, dizziness. or maintenance therapy, within broader treatment protocol/programme, accompanied by regular PROTAMINE SULPHATE LEO reviews and reassessment. PHARMA LEO Pharma P Initially 10-20mg by mouth. Increase as 2NO necessary by 10-20mg daily until there are no Heparin antagonist. Protamine sulphate 1400 antisigns of withdrawal or intoxication. After heparin IU/ml (equiv. 10mg/ml). Preservative free. stabilisation (often achieved with 40-60mg daily), Amp. 5 x 5ml, A43.02. gradually decrease until total withdrawal S Heparin or tinzaparin antidote. achieved. Renal impairment: Caution. GFR 10P 1ml (10mg) neutralises 1,400 IU of 50ml/min, dosage interval 8 hourly minimum; heparin. 1ml (10mg) partially neutralises 1,000 GFRQ10ml/min, dosage interval 12 hourly anti-Xa IU LMWH (tinzaparin). minimum. Hepatic impairment: Use less than B Excessive dosage may prolong the normal recommended dose, using patient’s coagulation time, thrombocytopenia. Pregnancy, response as guide. lactation. R Careful monitoring advised. A Anaphylactic reactions. Q Not recommended. hours. Over the next 12 weeks, use 1-2 per day only on occasions when strongly tempted to smoke. During weeks 1-6 itis recommended that users take a min. of 9 per day. Users should not exceed 15 per day and use for max. 24 weeks (6 months). Q Not recommended. D Non-smokers, occasional smokers. Myocardial infarction, unstable or worsening angina pectoris, Prinzmetal’s angina, severe cardia arrythmias, recent cardiovascular accident. B CVD e.g. stable angina pectoris, HF, cerebrovascular disease, vasospastic disease, severe peripheral disease, uncontrolled hypertension, atopic or eczemalous dermatitis, severe renal or hepatic impairment or active peptic ulcers, hyperthyroidism, pheochromocytoma, insulindependent diabetes. C Theophylline, insulin, See SPC. A Local irritation, See SPC.
D Respiratory depression (esp. cyanosis, excessive bronchial secretions), bronchial asthma attack, acute alcoholism, head injury, raised intracranial pressure, ulcerative colitis, severe hepatic impairment, biliary and renal tract spasm, labour. B May occur: Deaths due to cardiac arrhythmias and respiratory depression (caution during dose initiation and adjustment period), QT
risk of relapse, support abstinence and reduce alcohol craving. P 1 daily for an initial period of 3 months. Q Not recommended. D Acute hepatitis, liver failure, positive screen for opioids. B Monitor liver function before and during treatment. Impaired hepatic/renal function; caution. Narcan challenge recommended. Suicidality. Pregnancy, lactation (if benefit outweighs risk). Driving/ operating machines. C Opioid containing drugs (contra). A Nausea, headache, dizziness, fatigue, anxiety, GI disorders, joint and muscle pain, loss of appetite, thirst, increased energy, rash, decreased potency, chills, chest pain, sweating, increased lacrimation.
SUBUTEX
Schering-Plough
0JL Opiate. Buprenorphine (HCl) 0.4mg, 2mg, 8mg. Sublingual tab. Prices on request. S Substitution treatment for major opioid drug dependence, within a comprehensive therapeutic monitoring framework of medical, social and psychological treatment. P Initially 0.8-4mg single daily dose sublingually. The dose should be increased progressively up to max. 32mg single daily dose. After stabilisation reduce gradually to a lower maintenance dose; when deemed appropriate, treatment may be discontinued. Q Under 15 years, not recommended. D Severe respiratory or hepatic insufficiency, acute alcoholism or delirium tremens, acute asthma attack, head injury, increased intracranial pressure. Lactation. 2nd and 3rd trimester of pregnancy. B Hepatitis, hypotension, prostatic hypertrophy, urethral stenosis, asthma or respiratory insufficiency, renal or hepatic insufficiency. Driving, using machines. C Alcohol. Caution: Benzodiazepines, other CNS depressants, other opioid derivatives, certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics, neuroleptics, clonidine, MAOIs. A Constipation, headache, insomnia, asthenia, drowsiness, nausea, vomiting, fainting, dizziness, orthostatic hypotension, sweating.
XANAX
Pharmacia
2NO
Medium-acting benzodiazepine. Alprazolam 0.25mg, 0.5mg, 1mg. White, pink and lavender oval scored tabs. marked UPJOHN 29, UPJOHN 55 and UPJOHN 90 resp. 0.25mg-100, A2.11; 0.5mg100, A4.06; 1mg-100, A8.48. S Anxiety when the disorder is severe, disabling or causing extreme distress. P 0.5-1mg daily in divided doses, increasing in increments not greater than 1mg every 3-4 days to 3-4 daily. Max. treatment duration, 8-12 weeks. R 0.25mg twice daily. Q Not recommended. REVIA BMS D Myaesthenia gravis, severe respiratory 2NO or hepatic insufficiency sleep apnoea syndrome. Narcotic antagonist. Naltrexone (HCl) 50mg. Pale B Tolerance, physical and psychic yellow, film-ctd, cap.-shaped tab. scored and pendence, anterograde amnesia, psychiatric and marked R11on one side, 50 on reverse. 28, paradoxical reactions (e.g restlessness, agitation, A62.09. irritability, aggressiveness, delusion, rages, S For use with a comprehensive treatment nightmares) programme for alcohol dependence to reduce the C Alcohol, CNS depressants.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
319
19.1 DIAGNOSTIC
DIAGNOSTIC
AGENTS
A Amnesia, drowsiness, depression, pychiatric and paradoxical reactions, dependence.
U
ZYBAN
U
OU
request. S Detection of blood glucose levels in 0.633.3mmol/l range, test time 5 secs. Suitable for use with Accu-Chek Aviva meter.
CLINITEST
GSK ALSO ACCU-CHEK SYSTEM 1, price available on
2NO NA and dopamine re-uptake inhibitor. Bupropion (HCl) 150mg. White film-ctd sust.-release tab. marked GX CH7. 100, A99.42. S Aid to smoking cessation in combination with motivational support in nicotine-dependent patients. P Initially 150mg once daily for 6 days, then 150mg twice daily (8 hrs apart) for remainder of 7-9 weeks therapy. Max. single dose 150mg; daily 300mg. Stop smoking 2nd week of course. Elderly, renal/hepatic impairment: Max., 150mg once daily. Q Under 18 years, not recommended. D Current/history of seizure disorder, bulimia, anorexia nervosa, severe hepatic cirrhosis, bipolar disorder, CNS tumour, abrupt alcohol/ benzodiazepines withdrawal. Pregnancy, lactation. B Predisposition to lowered seizure threshold/increased risk of seizures (previous head injury, medications lowering seizure threshold, diabetes, stimulant use or anorectic products), use if benefit outweighs risk (max. 150mg daily). Hypertension, depressed mood, hypersensitivity. C Contra: MAOIs (irreversible, 14 days apart; reversible, 24 hrs). Alcohol, avoid. Caution: Substrates of CYP2D6 (antidepressants, antipsychotics, b-blockers, type 1C antiarrhythmics) or CYP1A2, orphenadrine, cyclophosphamide, ifosfamide, metabolism inducers/inhibitors, levodopa or amantadine. A Dry mouth, GI abdominal disorders, insomnia, tremor, concentration disturbance, headache, dizziness, depression, agitation, anxiety, rash, pruritus, urticaria, sweating, fever, taste disorders.
ACCU-CHEK ACTIVE OU
ALSO ACCU-CHEK ACTIVE GLUCOSE CONTROLS 1, A11.35.
U ALSO ACCU-CHEK ACTIVE SYSTEM 1, price available on request. S Detection of blood glucose levels in 0.633.3mmol/l range, test time 10 secs. Suitable for use with Glucotrend meters.
ACCU-CHEK ADVANTAGE PLUS Roche Diagnostics
OU Test strip. 50,
OU
U ALSO ACCU-CHEK ADVANTAGE II CONTROLS 1, A11.35.
U ALSO ACCU-CHEK ADVANTAGE SYSTEM 1. Price available on request. S Detection of blood glucose levels in 0.633.3mmol/l range. Suitable for use only with AccuChek Advantage meter.
ACCU-CHEK AVIVA
Roche Diagnostics
OU Test strip. 50, A22.10.
Bayer HealthCare
OU
Omega
OU
U ALSO ACCU-CHEK COMPACT GLUCOSE CONTROLS 1, A11.35.
U ALSO ACCU-CHEK COMPACT PLUS SYSTEM 1, price available on request. S Detection of blood glucose levels in 0.633.3mmol/l range. For use with Accu-Chek Compact and Compact Plus meter.
Urine test strips. 50 strips, A11.81. S Detection of; glucose, ketone, nitrates, pH, specific gravity, bilirubin, urobilinogen, protein or blood in urine
OU ALSO COMBINA 3 50 strips, A6.60. S Detection of protein, pH, glucose in urine
U
ACCU-CHEK MULTICLIX
ALSO COMBINA 2 50 strips, A5.21.
OU
OU
Roche Diagnostics S Detection of glucose and ketones in
urine.
Blood lancet 0.3m/30 gauge. 200 (+4), A12.62. S Suitable for use with Accu-Chek Multiclix finger pricker. Roche Diagnostics
OU Blood lancet 0.4 mm/28 gauge. 200, A10.30. S Suitable for use with Softclix finger pricker.
ACETEST
ALSO COMBINA GLUCOSE 50 strips, A4.19. S Detection of glucose in urine
COMBUR-3 TEST
ACCU-CHEK SOFTCLIX
Siemens Diagnostics
Roche Diagnostics
U Test strip with 3 test areas. 50 strips, A8.43. S Detection of pH, protein and glucose in urine.
OU ALSO COMBUR-5 TEST D 50, A11.97. S Detection of pH, protein, ketone, glucose and blood in urine.
OU ALSO COMBUR-7 TEST 100, A23.73. S Detection of pH, leucocytes, nitrite, protein, glucose, ketones and blood in urine.
OU Siemens Diagnostics ALSO COMBUR-9 TEST 50, A19.78; 100, A28.52.
OU
S Detection of nitrite, pH, protein, glucose, ketone, urobilinogen, bilirubin, blood and leucocytes in urine.
Test strip. 50, A6.06. S Detection of protein in urine.
BM-ACCUTEST
OU
Roche Diagnostics
OU Test strip. 50, A23.51. S Detection of blood glucose levels in range 1-33 mmol/l. Test time 12 seconds. Suitable for use only with Accutrend family of meters.
BREEZE 2
ALSO COMBUR-10 TEST 100, A37.31. S Detection of specific gravity, pH, leucocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood in urine.
CONTOUR
Bayer HealthCare
OU
Bayer HealthCare Blood Glucose Monitoring System. With No
OU
A23.00.
Test strip. 50, A4.89. S Detection of glucose in urine.
COMBINA
Test strip. 51 (3 x 17), A23.19.
ALBUSTIX
U
Siemens Diagnostics
Tablet. Pocket set-1, A6.29; Refills-36, A3.13. S Estimation of reducing substances in Roche Diagnostics urine.
Tablet. 100, A5.52. S Detection of ketones in urine, plasma Roche Diagnostics and serum.
Test strip. 50, A23.00.
CLINISTIX
ACCU-CHEK COMPACT
OU
19.1 DIAGNOSTIC AGENTS
320
ALSO ACCU-CHEK AVIVA CONTROLS 1, A11.35.
AGENTS
Blood Glucose Monitoring System. With No Coding Technology, results in 5 seconds, 1mcl sample required. Memory capacity: 420 results with date and time. Blood glucose monitoring system, price available on request; Breeze 2 test strips, price available on request. S Monitoring of blood glucose.
CLEANLET TYPE C LANCET
Coding Technology, results in 5 seconds, 0.6mcl sample required. Memory capacity: 480 results with date and time. Blood glucose monitoring system, price available on request; Contour Microfill test strips, price available on request. S Monitoring of blood glucose.
DIABUR-TEST 5000
Roche Diagnostics
OU
Omega Test strip with 1 test area. 50 strips, A4.04.
U Lancet 200, A8.15. S Suitable for use with a number of finger pricking devices e.g. Autoclix, Autolet, B-D Lancer, Glucoles Hemalet, Penlet.
S Semi-quantitative estimation of urine glucose. Range 0.1-5%, visual.
DIASTIX
Bayer HealthCare
OU
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
DIAGNOSTIC
DIAGNOSTIC
AGENTS
Test strip. 50, A4.16. S Detection of glucose in urine.
functional capacity and response of gonadotrophic pituitary reserve of luteinising hormone and follicle stimulating hormone in patients with DRUG SCREEN Omega possible impairment of pituitary function or hypothalamopituitary function. U P 0.1 mg as a single dose given by rapid Test card. 10 test cards, A298.77. SC or IV inj. in early follicular phase of cycle (days S Simultaneous rapid testing for 10 1-7). different drugs of abuse: amphetamines, Q Under 1 year, not recommended. barbiturates, benzodiazedines, cocaine, D Pregnancy, lactation. methamphetamine, methadone, opiates, TCAs, C Drugs affecting pituitary gonadotrophin THC, phencyclidine. production incl. oestrogens, progestogens, U androgens and glucocorticoids. Digoxin, ALSO DRUG SCREEN 2 10 test cards, A164.32. phenothiazines, levodopa, spironolactone and S Simultaneous rapid testing for 5 dopamine. different drugs of abuse: cocaine, THC, benzodiazepines, methadone, opiates. HEMA-COMBISTIX Siemens Diagnostics
U
A164.32.
ALSO DRUG SCREEN 1 10 test cards, S Simultaneous rapid testing for 5 different drugs of abuse: amphetamines, barbiturates, benzodiazepines, opiates,methamphetamine.
FREESTYLE LITE
ALSO HEMASTIX 50, A15.55. Abbott S Detection of blood in urine.
Blood glucose monitoring systems. FreeStyle Lite: No Coding Required. Small meter using 0.3mcl blood sample. Coulometric technology. Average 5 sec. test time. Backlit for easy testing day and night. 400 reading memory. FreeStyle Freedom Lite: No Coding Required. Blood sample of 0.3mcl required. Average 5 sec. test time. Larger, easy to use buttons. Curved shape comfortable to hold. Freestyle Lite test strips only to be used with Freestyle Lite/Freedom Lite meters. Freestyle Lite/ Freedom Lite blood glucose monitoring systems, prices on request; Freestyle Lite test strips, A21.25; Freestyle Lancets, A8.29. S Monitoring of blood glucose in the range of 1.1-27.8mmol/L.
U
Test strip. 50, A19.51. S Detection of pH, glucose, protein, blood in urine.
U
OU
GLUCOMEN
OU
HEXAGON U
Rapid test. 20 tests, A80.00. S Detection of anti-bodies to Helicobacter pylori in whole blood/serum or plasma.
U ALSO GLUCOMEN LANCETS FINE Longitudinally fluted cylindrical mount 0.45mm 26 gauge. 200, A8.29. S For use with GlucoJect Plus 2 Pen.
GLUCOSTIX
Test strip. 50, A24.77. S Semi-quantitive estimation of blood glucose. Visual or meter reading.
Diagnostic. Gonadorelin 0.1mg. Powder and solvent for soln. for inj. in single unit vial. 1, A 22.61. S Evaluation and assessment of the
MULTISTIX 10 SG
Bayer HealthCare
Test strip. 100, A42.58. S Detection of pH protein, glucose, ketones, bilirubin, blood, nitrite, leucocytes and specific gravity in urine.
OU ALSO MULTISTIX 8 SG 100, A36.50. S Detection of glucose, ketones, specific gravity, blood, pH, protein, nitrites and leucocytes. ALSO MULTISTIX SG 100, A36.69. S Detection of pH, protein, glucose, ketones, bilirubin, blood and urobillinogen.
OU ALSO MULTISTIX GP 25, A10.32. S Detection of glucose, ketones, specific gravity, bleed, pH, protein, nitrites and leucocytes.
OU Test strip. 50, A4.41. S Detection of ketones in urine, plasma and serum.
KETUR TEST
NMP22 BLADDERCHEK
RB-Medical
U Point of care test. Test cassette for urine sample. Box of 24 test kits, A552.00 (A23.00 per test kit).
Roche Diagnostics S Screening for bladder cancer.
OU Test strip with 1 test area. 50, A3.89. S Detection of ketones in urine. Siemens Diagnostics
OU
Test strip. 100, A32.23. S Detection of pH, protein, glucose, ketones and blood in urine.
OU
OMEGA 1-STEP PREGNANCY TEST Omega U Rapid test. 2 tests, A4.10; 10 tests, A11.75; 25 tests, A27.00; 100 tests, A90.00. S One step pregnancy test (hCG in urine)
OMEGA A BLOOD LANCE
Omega
OU
S Detection of pH, protein, glucose, ketones, blood and specific gravity in urine. Roche Diagnostics
Lancet. 200, A8.29. S Suitable for use with a number of finger pricking devices such as Autoclix, Soft Touch, Autolet, Penlet, Glucolet.
ONETOUCH RANGE
OU S Rapid detection of microalbuminuria in urine.
OU
Siemens Diagnostics
OU
Test strip. 100, A44.28. S Detection of pH protein glucose, ketones, bilirubin, blood, nitrite and specific Bayer HealthCare gravity in urine.
KETOSTIX
MICROALBUSTIX
Siemens Diagnostics
Test strip. 100, A37.64. S Detection of pH, protein, glucose, ketones, blood and nitrite in urine.
N MULTISTIX SG
OU
MICRAL-TEST
Siemens Diagnostics
OU
OU
Intrapharm Labs. Test strip. 30, A52.50.
6U
Lancet. Type C. 200, A8.15. S Suitable for use with finger pricking devices such as: Autoclix, Auto Lancet, Autolet Lite, Autolet Mini, B-D Lancer, Glucolet, Hypolet, Microlet Valculance.
N LABSTIX
Siemens Diagnostics ALSO LABSTIX SG 100, A32.24.
OU
H.R.F
Roche Diagnostics
KETO-DIASTIX
Bayer HealthCare
OU
Test strip with 2 test areas. 50, A8.14. S Quantitative estimation of ketone and glucose in urine.
GLUCOMETER ELITE TEST SENSORS Bayer HealthCare LABSTIX OU Foil sealed sensor. 50, A26.23. S Detection of blood glucose levels in range: 1.1-33.3 mmol/l. Test time 30 secs. using Gucometer Elite meter.
MICROLET
OU
Test strip. 50, A7.29. A. Menarini Diagnostics S Detection of ketones and glucose in urine.
Test strips. Biosensor test strips. 50, A22.94. S Detection of blood glucose levels in range 1.1-33.3 mmol/L. Test time 30 secs. For use with GlucoMen Glyco and GlucoMen PC.
Test strip. 25, A52.64. S Detection of albumin and creatinine in urine; provides a semi-quantitative albumin/ creatinine ratio. Test time 1 min.
OU Omega
KETO-DIABUR TEST
19.1
AGENTS
Lifescan
OU
Test strip. 50, A23.85. S Detection of blood glucose levels in range 1.1- 33.3 mmol/L. Test time 5 secs. For use Siemens Diagnostics with OneTouch Ultra and OneTouch UltraSmart meters.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
321
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
OU
OU
ALSO ONETOUCH ULTRASOFT LANCET 200, A8.23. S Suitable for use with OneTouch UltraSoft finger pricker.
Test strip. 50, A10.33. S Detection of protein and glucose in urine.
OPTIUM XCEED
20.1 NEOPLASTIC DISORDERS Abbott
OU Blood glucose and ketone monitoring system. Biosensor technology. 3 sec. test time, 0.3mcl sample size for glucose. Blood glucose monitoring system, price on request; Optium Plus test strips, A20.43; b-Ketone test strips-10, A27.50. Abbott Thin lancets, A8.23. S Monitoring of blood glucose and blood ketones.
QED
Omega
U Rapid test. A130.71, 10 tests. S Determination of alcohol in saliva.
RAPIGNOST BASIC SCREEN PLUS Advance OU Test strip. 100, A15.00. S Rapid determination of ascorbic acid, glucose, protein, blood, pH and nitrites in urine.
OU ALSO RAPIGNOST DIABETES PROFILE 50, A6.90. S Rapid determination of ketones, ascorbic acid and glucose in urine.
OU ALSO RAPIGNOST TOTAL SCREEN LSG 100, A22.50. S Rapid determination of pH, glucose, protein, leucocytes, ketones, bilirubin, urobilinogen, blood, nitrite, specific gravity and ascorbic acid in urine.
REFLOTRON PLUS
Roche Diagnostics
U Quantitative diagnostic. The system features an integrated multifunctional Cardiac Risk Assessment programme. Samples are applied directly to precalibrated test strips with results being available within 2-3 mins. Price available on request. S Quantitative determination of 16 clinical chemistry parameters in whole blood, serum or plasma.
TESTPACK hCG-URINE U Immunoassay. Double monoclonal antibody immunoassay. Test kits, 20, A59.68. S Pregnancy testing.
Abbott
ACTAVIS EPIRUBICIN
Actavis
2JN Anthracycline. Epirubicin 2mg/ml. Soln for inj. 5ml, 25ml vials; prices on request. S Carcinoma of the breast, advanced ovarian cancer, gastric cancer, small cell lung cancer. When admin. intravesically, beneficial in carcinoma of the bladder (papillary transitional cell carcinoma, carcinoma-in-situ, prophylaxis of recurrences following transurethral resection). P Conventional dose: 60-90mg/m2 body area injected IV over 3-5 minutes; repeat at 21-day intervals depending on haematomedullary status. SCLC: 120mg/m2 day 1, every 3 weeks. Breast cancer: 100mg/m2 (as single dose on day 1) to 120mg/m2 (in two divided doses on days 1 and 8) every 3-4 weeks. See SPC for other doses and admin. route. Avoid cumulative dose q 9001000mg/m2 (increased risk of CHF). Impaired liver function: Reduce dose (see SPC). Q Lack of data. D Myelosuppression induced by previous chemo/radiotherapy. Patients treated with max. cumulative doses of other anthracyclines (e.g. doxorubicin, daunorubicin). Current or history of cardiac impairment. Acute systemic infections. Severe liver impairment. Severe mucositis of mouth, pharynx, oesophagus and GI tract. Intravesical admin: UTI, invasive tumours penetrating bladder, catheterisation problems, vesicular inflammation, large volume of residual urine, contracted bladder. Lactation, pregnancy (unless benefit outweighs risk). B Admin. under supervision of physician experienced in the use of chemotherapeutic agents. Use contraception during and up to 6 months after treatment. Possibility of infertility. Monitor various laboratory parameters and cardiac function before treatment. ECG recommended before and after each treatment cycle. Carefully monitor blood parameters both before and during each cycle. Cardiomyopathy, hyperuricaemia. Hepatic impairment, renal impairment with serum creatinine q5mg/dl. C Dexverapamil, dexrazoxane, docetaxel, interferon a2b, paclitaxel, quinine, cimetidine, agents affecting hepatic function. Agents influencing bone marrow, cardiotoxic agents, radiotherapy to mediastinal area, agents causing HF, eg. Ca++ channel blockers. Live, attenuated vaccines (not recommended). A GI disorders, loss of appetite, oesophagitis, hyperpigmentation of oral mucosa, alopecia, hot flushes, chemical cystitis, mucositis, allergic reactions after intravesical admin. Myelosuppression, fever, infections, sepsis.
performance status 2. Locally advanced or metastatic epithelial ovarian carcinoma, in combination with carboplatin, in relapsed disease following a recurrence-free interval of at least 6 months after platinum-based, 1st-line therapy. In combination with paclitaxel, for unresectable, locally recurrent or metastatic breast cancer in relapsed disease following adjuvant/ neoadjuvant chemotherapy including an anthracycline. P Bladder cancer: 1000mg/m2 by IV inf. over 30 min. on days 1,8,15 of each 28 day cycle with cisplatin 70mg/m2 on day 1 following gemcitabine or on day 2. Pancreatic cancer: 1000mg/m2 by IV inf. over 30 min. once weekly for 7 weeks followed by a week of rest. Subsequent cycles, once per week for 3 out of every 4 weeks. NSCLC: Single agent use: 1000mg/m2 by IV inf. over 30 min. once weekly for 3 weeks followed by a week of rest. Repeat cycle. Combination use: Gemcitabine 1250mg/m2 given by IV inf. over 30 min. on days 1 and 8 of each 21 day cycle. Cisplatin dose range: 75-100mg/m2 once every 3 weeks. Breast cancer: Paclitaxel 175mg/m2 on day 1 over approx. 3 hours as IV inf., followed by gemcitabine 1250mg/m2 as 30 min. IV inf. on days 1 and 8 of each 21 day cycle. Ovarian cancer: 1000mg/m2 on days 1 and 8 of each 21-day cycle as 30 min IV inf. After gemcitabine, admin. carboplatin on day 1, with target AUC of 4mg/ml/ min. Adjust dose according to blood counts (see SPC). Q Under 18 years, not recommended. D Lactation. Pregnancy (unless clearly necessary). B Prolongation of inf. time and increased dosing frequency increase toxicity. Monitor prior to each dose for platelet, leucocyte and granulocyte counts. Hepatic or renal insufficiency, history of cardiovascular events. Pulmonary effects, haemolytic uraemic syndrome reported. Possibility of male infertility. Male contraception advised up to 6 months after treatment. Contains Na+. C Avoid live attenuated vaccines, radiotherapy. A Myelosuppression (anaemia, leucopenia and thrombocytopenia), febrile neutropenia. Raised liver enzymes, proteinuria, hematuria, dyspnoea, allergic skin rashes. GI disorders, dyspnoea, anorexia, headache, somnolence, insomnia, cough, rhinitis, alopecia, itching, sweating, back pain, myalgia, flu-like symptoms, oedema.
ACTAVIS IRINOTECAN
Actavis
2JN
Topoisomerase 1 inhibitor. Irinotecan HCl trihydrate 20mg/ml. Concentrate for soln for inf. S Advanced colorectal cancer, in combination with 5-fluorouracil and folinic acid in THINPREP PAP TEST Cytyc patients without prior chemotherapy. Monotherapy if established 5-fluorouracil U containing treatment regimen failed. Diagnostic. Approved replacement for P Monotherapy: 350mg/m2 as an IV inf. Conventional Pap Smear. over 30-90 min every three weeks. Combination S Cervical screening with further testing ACTAVIS GEMCITABINE Actavis therapy: 180mg/m2 every 2 weeks by IV inf. over from the ThinPrep vial (e.g. additional cytology 2JN 30-90 min followed by inf. with folinic acid and 5preparations, HPV testing). Nucleoside analogue. Gemcitabine (as HCl) 200mg, fluorouracil. Impaired hepatic function: See SPC. TODAY OVULATION TEST Omega 1g. Concentrate for soln for inf. Prices on request. Q Not recommended. D Chronic IBD, bowel obstruction. S Locally advanced or metastatic bladder U Pregnancy and lactation. Bilirubin q3 x ULN, cancer in combination with cisplatin. Locally Diagnostic agent. 7-Tests, A17.78. severe bone marrow failure, WHO performance advanced or metastatic adenocarcinoma of S Detection of an increase in LH in female pancreas. In combination with cisplatin, 1st line status q 2. urine B Monitor complete blood cell counts treatment of locally advanced or metastatic nonweekly. Perform liver function tests at baseline small cell lung cancer (NSCLC). Monotherapy can URISTIX Siemens Diagnostics be considered in elderly patients or those with and before each cycle. Antiemetics recommended
322
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
before each treatment. Asthma, risk for interstitial pulmonary disease, elderly. Contains sorbitol. Contraception required during and for at least 3 months after. Driving/using machines. C St John’s Wort (contra). Avoid strong inhibitors or inducers of CYP3A4. Drugs with anticholinesterase activity. A Delayed diarrhoea (hydrate and initiate antidiarrhoeal therapy), other GI disorders. Neutropenia, anaemia. Acute cholinergic syndrome (admin. atropine sulphate), asthenia, fever, reversible alopecia. Increase in enzyme serum levels.
severe elevation in AST and alkaline phosphatase.
AFINITOR
occur. Pregnancy. Contains methyl/ propylhydroxybenzoate, cetyl/stearyl alcohol.
Novartis A Local skin reactions, skin colour
2T
mTOR inhibitor. Everolimus 5mg, 10mg. White to slightly yellow, elongated tab. with bevelled edge. Engraved with NVR on one side and 5 or UHE resp., on the other. 5mg-30, A2829.13; 10mg-30, A4041.62. S Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. P 10mg once daily. Continue as long as clinical benefit observed or until unacceptable ACTAVIS PACLITAXEL Actavis toxicity occurs. Severe and/or intolerable adverse 2JN reactions may require dose reduction to 5mg daily or temporarily withholding followed by Taxane. Paclitaxel 6mg/ml. Conc. for soln. for inf. in vials. 5ml,16.7ml, 25ml, 50ml; prices on request. reintroduction at 5mg daily. Moderate hepatic impairment: 5mg daily. S Ovarian cancer: 1st line treatment of Q Under 18 years, not recommended. advanced ovarian cancer or with residual disease D Pregnancy, lactation. (q1cm), in combination with cisplatin. 2nd line B May occur: Non-infectious pneumonitis treatment of metastatic ovarian cancer where (advise to promptly report new or worsening platinum therapy has failed. Breast cancer: respiratory symptoms; discontinue if severe), Adjuvant treatment of node-positive breast carcinoma following anthracycline and infections (esp. opportunistic pathogens), cyclophosphamide (AC) therapy (as alternative to hypersensitivity reactions, mouth ulcerations, extended AC therapy). Initial treatment of locally impaired wound healing (caution in peri-surgical advanced or metastatic breast cancer in period). Monitor renal function, fasting serum combination with either anthracycline or glucose and complete blood count prior to trastuzumab (in patients over-expressing HER2 at a starting therapy and periodically thereafter. Severe 3+ level when anthracycline is not suitable). As hepatic impairment, not recommended. Contains single agent, metastatic breast cancer where lactose. anthracycline has failed or is not suitable. C Avoid live vaccines, grapefruit juice. Not Advanced non-small cell lung carcinoma (NSCLC): recommended: Potent inhibitors/inducers of In combination with cisplatin where surgery and/ CYP3A4 or PgP. Caution: Moderate inhibitors and or radiation therapy not suitable. AIDS-related substrates of CYP3A4 or PgP. Kaposi’s sarcoma (KS) where liposomal A Infections, decreased lymphocytes / Hb / anthracycline therapy has failed. platelets / neutrophils, increased glucose / P By IV inf, repeated every 3 weeks cholesterol / triglycerides, decreased phosphate, (except for KS). Ovarian cancer, 1st line: 175mg/ anorexia, dehydration, insomnia, abnormal taste, m2over 3 hrs followed by cisplatin 75mg/m2, or headache, conjunctivitis, eyelid oedema, 135mg/m2 over 24 hrs followed by cisplatin 75mg/ hypertension, pneumonitis, dyspnoea, epistaxis, m2. Ovarian and breast cancer, 2nd line: 175mg/m2 cough, haemoptysis, GI disorders, increased ALT / over 3 hrs. Breast cancer, adjuvant: 175mg/m2 over AST / bilirubin, rash, dry skin, pruritus, palmar3 hrs, for 4 courses following AC therapy. Breast plantar erythrodysaesthesia syndrome, erythema, cancer, 1st line: With doxorubicin, 220mg/m2 over skin exfoliation, nail disorder, acneiform 3 hrs admin. 24 hrs after doxorubicin (50mg/m2). dermatitis, onychoclasis, increased creatinine, With trastuzumab, 175mg/m2 over 3 hrs starting fatigue, asthenia, peripheral oedema, chest pain, day after 1st dose of trastuzumab, or immediately pyrexia, weight decreased. after subsequent dose of trastuzumab if well tolerated. NSCLC: 175mg/m2 over 3 hrs, followed ALDARA Meda by cisplatin 80mg/m2. KS: 100mg/m2 over 3 hrs 2MO every 2 weeks. Pretreat with corticosteroids, Immunomodulator. Imiquimod 5%. Cream in antihistamines and H2-antagonists. single use sachets. Box of 12, A70.99. D Patients with baseline neutrophils 3 3 Q1,500/mm (Q1,000/mm for KS). Pregnancy (use S Small superficial basal cell carcinomas (sBCCs). Actinic keratoses (AKs) on face or scalp in contraception up to 1 month after treatment for immunocompetent adult patients when size or women and 6 months for men), lactation. KS: number of lesions limit efficacy and/or Serious uncontrolled infections. B Caution: Hepatic impairment (if severe, acceptability of cryotherapy and other topical treatments are contraindicated/less appropriate. do not use). Discontinue if significant P sBCCs: Apply 5 times per week for 6 hypersensivity reactions occur. Monitor blood weeks at bedtime, and leave for approx. 8 hrs. counts. May occur: Cardiac conduction AKs: Apply 3 times per week for 4 weeks at abnormalities (monitor), pseudomembranous bedtime and leave for approx. 8 hrs. Assess after a colitis, interstitial pneumonitis, severe mucositis 4-week treatment-free period. If any lesions (KS). Contains ethanol, macrogolglycerol persist, repeat treatment for another 4 weeks. ricinoleate. C Caution: Inducers or inhibitors of Max dose: 1 sachet. Max duration: 8 weeks. CYP3A4 or CYP2C8 (see Appendix I). Q Not recommended. A Infection (UTI, RTI), myelosuppression, B Avoid: Open wounds, 1cm of eyelids, neutropenia, anaemia, thrombocytopenia, nose, lips or hairline. Do not use occlusive leucopoenia, bleeding, minor hypersensitivity dressings. Caution: Autoimmune conditions, organ reactions, neurotoxicity (peripheral neuropathy), transplant patients. Protect from sun. Use for bradycardia, hypotension, GI disturbances, previously treated tumours (not recommended). alopecia, arthralgia, myalgia, inj. site reactions, Rarely, intense local inflammatory reactions may
changes, infection, pustules, back pain, lymphadenopathy.
ALIMTA
Lilly
2JN Folic acid analogue. Pemetrexed 500mg (as pemetrexed disodium). Powder for concentrate for soln for inf. Vial, price available on request. S In combination with cisplatin for treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma. In combination with cisplatin for 1st-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer (NSCLC) other than predominantly squamous cell histology. As monotherapy for maintenance treatment of locally advanced or metastatic NSCLC other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (1st-line treatment should be platinum doublet with gemcitabine, paclitaxel or docetaxel). As monotherapy for 2nd-line treatment of patients with locally advanced or metastatic NSCLC other than predominantly squamous cell histology. P 500mg/m2 of body surface area as IV inf. over 10 mins on 1st day of each 21-day cycle. Admin. corticosteroid day prior to, on day of, and day after pemetrexed adm. NSCLC: Approx. 30 mins after completion of pemetrexed inf., admin. Cisplatin 75mg/m2 as inf. over 2 hrs. Dose adjustment: See SPC. Q Under 18 years, not recommended. D Pregnancy (unless essential), lactation. Yellow fever vaccine. B Monitor for myelosuppression. Take oral folic acid (at least 5 doses in the 7 days prior 1st Alimta dose) and vit. B12 (IM inj.) to reduce treatment-related toxicity. Adequate anti-emetic treatment and hydration required. cc Q45ml/min (not recommended). Serious renal events, colitis, interstitial pneumonitis, radiation pneumonitis reported. Clinically significant third space fluid. Males advised not to father child during treatment and up to 6 months thereafter. Driving/ using machines. C Live attenuated vaccines, not recommended. Avoid NSAIDS (5 days prior and 2 days after). Caution: Nephrotoxic drugs or substances tubularly secreted (eg, probenecid, penicillin), oral anticoagulants, radiation, radiosensitising agents. A Decreased neutrophils, leucocytes, granulocytes, Hb, platelets. GI disorders, conjunctivitis, fatigue, fever, dehydration, neuropathy-sensory, taste disturbance, creatinine elevation, cc decreased, rash/desquamation, alopecia, increased AST/ALT.
ALKERAN
GSK
2NO Alkylating agent. Melphalan 2mg. White film-ctd tab. coded GXEH3 one side, A on reverse. 25, A12.31.
2N ALSO ALKERAN INJECTION Melphalan 50mg. Vial. 1, A62.10.
ANDROCUR 100
Bayer Schering
2NO Anti-androgen. Cyproterone (acetate) 100mg. Off-
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
323
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
white cap.-shaped scored tab. marked LA each side of score, hexagon on reverse. 60, A82.14. S Prostatic carcinoma. P Prostatic carcinoma, monotherapy: 100mg two or three times daily. Reduction of LHRH agonist tumour flare: initially 100mg twice daily alone for 5-7 days, followed by 100mg twice daily for 3-4 weeks, with LHRH agonist in dosage recommended by manufacturer. Elimination of effect of adrenocortical androgens with LHRH agonist/orchiectomy: 100mg once or twice daily. D Acute liver disease. Malignant/wasting diseases (other than prostatic carcinoma); severe chronic depression; history of thrombosis/ embolism. Age Q 18 or incomplete bone/testicular development. B See SPC. C See SPC. A See SPC.
of 30-60mg over 2-4 hours is adequate for mild hypercalcaemia. Severe hypercalcaemia requires 90mg. TIO: Initially single IV inf. of 30mg weekly adjusting after reassessment of the patient. Paget’s: 180mg IV inf., as 30mg once weekly for 6 weeks or initial 30mg dose followed by 60mg every other week over 3 weeks. Max. 360mg, can repeat every 6 months if required. Dilute before use. Do not give as a bolus inj. Q Not recommended. B Pregnancy. Severe renal insufficiency. Possibility of precipitating convulsions due to electrolyte changes. C Infusion solutions containing Ca++, hypocalcaemic therapy, other bisphosphonates, plicamycin. A Asymptomatic hypocalcaemia. Mild transient pyrexia. Transient lymphocytopenia. Oliguria.
alopecia, joint/ musculoskeletal pain, dizziness, carpal tunnel syndrome, pain, peripheral oedema.
ATRIANCE
GSK
2J
Nucleoside analogue. Nelarabine 5mg/ml. Soln for inf. 6-50ml, price available on request. S T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. P 1,500mg/m2 intravenously over 2 hours on days 1, 3 and 5 and repeated every 21 days. Q Under 16 years: 650mg/m2 intravenously over 1 hour daily for 5 consecutive days, repeated every 21 days. Over 16 years: As per adults. B Severe neurological events, demyelination events, and ascending peripheral neuropathies have been reported. Close ARANESP Amgen ARIMIDEX AstraZeneca monitoring for neurological events is strongly 5NT 5NO recommended (discontinue at the first sign of events of NCI CTCAE Grade 2 or greater). Human erythropoietin. Darbepoetin alfa 10, 15, Aromatase inhibitor. Anastrozole 1mg. White 20, 30, 40, 50, 60, 80, 100, 150, 300 and 500mcg. biconvex film-ctd. tab. embossed with logo on one Concomitant intrathecal therapy and/ or Soln. for inj. in pre-filled syringe. 10mcg/0.4ml x 4, side and strength on reverse. 28, A89.08. craniospinal irradiation is not recommended A97.06; 15mcg/0.375ml x 4, A145.59; 20mcg/0.5ml (increased risk of neurotoxicity). Perform complete S Treatment of early breast cancer in x 4, A194.12; 30mcg/0.3ml x 4, A291.18; 40mcg/ blood counts regularly. IV hydration hormone receptive post-menopausal women. A A 0.4ml x 4, 388.24; 50mcg/0.5ml x 4, 485.30; recommended. Consider use of allopurinol in Treatment of advanced breast cancer in post 60mcg/0.3ml x 4, A582.36; 80mcg/0.5ml x 4, hyperuricemia. Elderly, increased rates of menopausal women. A776.48; 100mcg/0.5ml x 4, A970.60; 150mcg/ neurological adverse events. Known to be P 1mg once daily. No dose change in 0.3ml x 4, A1455.90; 300mcg/0.6ml x 1, A727.95; genotoxic to mammalian cells. Contains Na+. renal or hepatic impairment. A 500mcg/1ml x 1, 1091.93. Pregnancy, lactation (not recommended). Q Not recommended. 5NT C Immunisations with live organism D Pregnancy, lactation. ALSO ARANESP SURECLICK Darbepoetin alfa 20, B Children/pre-menopausal women (safety vaccines, adenosine deaminase inhibitors. 40, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. and efficacy not established), severe hepatic or A Infection, tumour lysis syndrome, febrile in pre-filled pen. 20mcg/0.5ml x1, A48.53; 40mcg/ renal impairment (consider potential risk/benefit). neutropenia, neutropenia, leukopenia, A A 0.4ml x1, 97.06; 60mcg/0.3ml x1, 145.59; thrombocytopenia, anaemia, hypoglycaemia, Loss of bone mineral density, increased fracture 80mcg/0.4ml x1, A194.12; 100mcg/0.5ml x1, hypocalcaemia, hypomagnesaemia, hypokalaemia, risk. A242.65; 150mcg/0.3ml x1, A363.98; 300mcg/0.6ml C Co-admin. of tamoxifen, oestrogenanorexia, confusional state, seizures, amnesia, x1, A727.95; 500mcg/1ml x1, A1091.93. somnolence, hypoesthesia, paresthesia, ataxia, containing therapies (decreased Arimidex S Symptomatic anaemia in adult cancer balance disorder, tremor, dizziness, headache, pharmacological action) patients with non-myeloid malignancies receiving dysgeusia, blurred vision, hypotension, pleural A Hot flushes, asthenia, joint pain/ chemotherapy. effusion, wheezing, dyspnea, cough, GI disorders, stiffness, vaginal dryness, hair thinning, rash, P 500mcg once every three weeks by SC hyperbilirubinaemia, increased transaminases/AST nausea, diarrhoea, headache, carpal tunnel inj; if response inadequate after 9 weeks, further increased, muscle weakness, myalgia, arthralgia, syndrome, hepatobiliary disorders. therapy may not be effective. Alternatively, back pain, pain in extremity, blood creatinine AROMASIN Pharmacia increased, oedema, gait abnormal, oedema 2.25mcg/kg once weekly. Continue therapy for approx. 4 weeks after end of chemotherapy. Hb peripheral, pyrexia, pain, fatigue, asthenia. 5NO should not exceed 13g/dl. Reduce the dose by 25- Irreversible aromatase inhibitor. Exemestane 25mg. Roche 50% once target achieved or if rise in Hb is q2g/ Round, biconvex, white ctd tab. marked 7663. 30, AVASTIN dl in 4 weeks. 2JN A135.00. D Poorly controlled hypertension. Patients S Adjuvant treatment of post-menopausal Monoclonal antibody. Bevacizumab 25mg per ml. suspected or confirmed to have neutralising Concentrate for soln for inf. in 100mg and 400mg women with oestrogen receptor positive invasive antibodies to erythropoietin. Lactation. vials. Price available on request. early breast cancer, following 2-3 years of initial B Evaluate iron status prior and during S In combination with fluoropyrimidineadjuvant tamoxifen therapy. Advanced breast treatment. Iron suppl. may be required. Monitor based chemotherapy for treatment of metastatic cancer in post-menopausal women where disease BP. Ischaemic heart disease, CHF, sickle cell carcinoma of the colon or rectum. In combination has progressed following anti-oestrogen therapy. anaemia, epilepsy. Liver disease (no data). Monitor P 1 daily preferably after meal. Early with paclitaxel for 1st-line treatment of breast K+ levels. PCRA (discontinue if occurs). Pregnancy. breast cancer, continue until completion of 5 years cancer. In addition to platinum-based C Caution: Cyclosporin, tacrolimus. sequential adjuvant hormonal therapy (tamoxifen chemotherapy for 1st-line treatment of A Headache, hypertension, thrombosis of unresectable advanced, metastatic or recurrent followed by Aromasin) or tumour relapse. vascular access, inj. site pain. non-small cell lung cancer (NSCLC) other than Advanced, continue until tumour progression. predominantly squamous cell histology. In Q Not recommended. AREDIA Novartis combination with interferon a-2a for 1st line D Pre-menopausal women. Pregnancy, 2N treatment of advanced and/or metastatic renal cell lactation. Bisphosphonate. Pamidronate disodium 15mg, cancer (mRCC). B Caution: Hepatic/ renal impairment; 30mg. Powder in vials and solvent (WFI) in amps. P Colon: Either 5mg or 10mg/kg BW once osteoporosis (or at risk of), assess bone mineral 15mg-4, A137.36; 30mg-2, A137.36; 90mg-1, every 2 weeks, or 7.5mg or 15mg/kg once every 3 density before use. Contains sucrose, methyl-pA242.63. weeks Breast: 10mg/kg once every 2 weeks or hydroxybenzoate. Hepatitis/ cholestatic hepatitis S Tumour-induced hypercalcaemia (TIH) 15mg/kg once every 3 weeks as IV inf. NSCLC: reported. and tumour-induced osteolysis (TIO). Paget’s 7.5mg/kg or 15mg/kg once every 3 weeks as IV inf. C Oestrogen-containing drugs (contra). disease of bone. in addition to platinum-based chemotherapy for CYP3A4 substrates and inducers (caution). P TIH: Total dosage is determined by up to 6 cycles followed by Avastin as single agent. A Anorexia, hot flushes, depression, patient’s initial plasma Ca++ levels. Single IV inf. mRCC: 10mg/kg once every 2 weeks as IV inf. headache, GI disorders, fatigue, sweating, rash,
324
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
General: 1st inf. over 90 mins; if well tolerated 2nd inf. over 60 mins and subsequent infs. over 30 mins. Admin. 1st dose following chemotherapy, and subsequent doses before or after chemo. Q Children and adolescents, not recommended. D Untreated CNS metastases. Pregnancy, lactation. B Wound healing complications. Hypertension; monitor BP. Monitor for proteinuria prior to and during therapy. Caution: Intraabdominal inflammation, elderly or history of arterial thromboembolic events, congenital bleeding diathesis or acquired coagulopathy, CHF, prior anthracycline exposure or prior radiation to chest wall. Increased risk of tumour-associated haemorrhage, fistula. Renal and hepatic impairment (not studied). Women must use contraceptive measures and not breast feed up to 6 months following therapy. A Peripheral sensory neuropathy, headache, fatigue, syncope, CHF, tachycardia, GI disorders, pain, hypertension, GI perforations, haemorrhage, arterial thromboembolism, palmarplantar, muscular weakness, proteinuria, UTI. Leucopenia, thrombocytopenia, neutropenia.
BICALINN
NEOPLASTIC DISORDERS 20.1
DISORDERS
Helsinn Birex
combination with luteinising hormone-releasing hormone (LHRH) analogue or surgical castration. P 1 tab. once daily at the same time each day (morning or evening). Start treatment within 1 week prior to LHRH analogue admin. or at same time as surgical castration. Q Not indicated. D Severe hepatic impairment. B Caution: Moderate hepatic impairment, severe renal impairment (ccQ30ml/min). Monitor hepatic function; discontinue if severe hepatic changes occur. Contains lactose. C Contra: Terfenadine, astemizole, cisapride. Caution: CYP3A4 metabolised drugs, drugs with narrow therapeutic effect, ciclosporin, Ca++ channel blockers, ketoconazole, cimetidine, coumarin anticoagulants. A GI disorders, hepatic changes (elevated transaminases levels, cholestasis and jaundice), breast tenderness, gynaecomastia, hot flushes, asthenia, pruritus, anaemia, diabetes mellitus, weight gain, decreased libido, dizziness, insomnia, rash, sweating, hirsutism, oedema, pain, pelvic pain, chills.
BICNU
A GI disturbances, hepatic changes (elevated transaminases levels, cholestasis and jaundice), breast tenderness, gynaecomastia, hot flushes, anaemia, diabetes mellitus, weight gain, dizziness, insomnia, rash, sweating, hirsutism, oedema, general pain, pelvic pain, chills.
BONDRONAT
Roche
2N
Bisphosphonate. Ibandronic acid (Na+ monohydrate ) 50mg. White to off-white, oblong, film-ctd tabs. engraved L2/IT. 28, A302.68. S Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. P 50mg daily taken after an overnight fast (at least 6 hours); before first food or drink of the day. Medicinals and suppl. (incl. Ca++) should be avoided prior to dosing. Fasting should be continued for at least 30 minutes after taking the tab.. Plain water may be taken at any time. tabs. should be swallowed whole with a full glass of plain water (180-240ml) with the patient standing/ sitting in an upright position. Patients should not BMS lie down for 60 minutes after dosing.
2NO
2J
ALSO BONDRONAT IV Ibandronic acid (Na+ monohydrate) 2mg/2ml. Ampoules/vials containing clear colourless soln. for infusion. 2mg/2ml-1 vial, Anti-androgen. Bicalutamide 50mg. White round A145.48; 2mg/2ml-5 ampoules, A727.41. biconvex film-ctd tab. 28, A123.53. S Prevention of skeletal events S Advanced prostate cancer in (pathological fractures, bone complications combination with LHRH analogue therapy or BILUTA Rowex requiring radiotherapy or surgery) in patients with surgical castration. breast cancer and bone metastases. Treatment of P 50mg once daily. Start treatment at the 2 N T tumour-induced hypercalcaemia with or without same time as commencing treatment with LHRH Anti-androgen. Bicalutamide 50mg. White round metastases. analogue or surgical castration. film-ctd tab. 28, A103.95. P Prevention of skeletal events: 6mg IV D Females and children. S Advanced prostate cancer in given every 3-4 weeks by 1 hour infusion. TumourB Caution: Moderate to severe hepatic combination with LHRH analogue therapy or induced hypercalcaemia: Severe, 4mg as single impairment. Consider periodic liver function surgical castration. monitoring. Discontinue if severe hepatic changes P 50mg once daily. Start treatment either dose. Moderate, 2mg as single dose. Q Not recommended (insufficient occur. Contains lactose. 3 days before or concomitantly with LHRH evidence). C Coumarin anticoagulants. analogue treatment, or concomitantly with D Bisphosphonate hypersensitivity (IV A Breast tenderness, gynaecomastia, GI surgical castration. form). Pregnancy. disorders, hepatic changes (elevated transaminases Q Not recommended. B Dysphagia, oesophagitis, oesophageal or levels, jaundice), hot flushes, asthenia, pruritus. B Caution: Moderate to severe hepatic gastric ulcers, pain on swallowing, retrosternal impairment, severe renal impairment. Consider pain, heartburn. Contains lactose (oral form). BICALUTAMIDE TEVA Teva periodic liver function monitoring. Discontinue if Monitor renal function, serum Ca++, phosphate 2NT severe hepatic changes occur. Contains lactose. and magnesium. Severe hepatic insufficiency Anti-androgen. Bicalutamide 50mg. White to offC Drugs with narrow therapeutic index (insufficient data), lactation. white biconvex, film-ctd tab., debossed with 93 (terfenadine, astemizole, cisapride, cyclosporin, C Products containing Ca++, aluminium, one side and 220 the other. 28, A107.67. Ca++ channel blockers), cimetidine, ketoconazole, magnesium, iron. NSAID, aminoglycosides. S Advanced prostatic carcinoma in coumarin anticoagulants. A Oral: Hypocalcaemia, GI disturbances, asthenia. IV: Prevention of skeletal events: Infection, parathyroid disorders, headache, dizziness, taste perversion, cataracts, bundle branch block, pharyngitis, GI disorders, musculoskeletal and skin disorders, asthenia, flu-like illness, peripheral oedema, thirst, elevated creatinine and gamma-GT. IV: Treatment of tumour-induced hypercalcaemia: Hypocalcaemia, bone pain, pyrexia.
2T
Alkylating agent. Carmustine 100mg. Powder in vial plus 3ml vial diluent. 1, A14.55. S Brain tumour, multiple myeloma, Hodgkin’s disease, non-Hodgkin’s lymphoma (secondary therapy with other agents).
EDITORIAL INFORMATION
The information published in the editorial listing in MIMS Ireland is based upon details supplied by the manufacturers. The Index lists preparations which are available on prescription in general practice.
BONEFOS
Bayer Schering
2MT Bisphosphonate. Sodium clodronate 800mg. White oval scored film-ctd tab. marked L134. 800mg-60, price available on request. S Increased bone resorption due to malignancy. Hypercalcaemia of malignancy. P Initially, 1600mg daily as single dose or in 2 divided doses taken between meals; may be increased up to max. 3200mg daily.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
325
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
Myeloma: 30mg/m2 on day 4 of the bortezomib 3 week regimen as a 1 hour inf. See SPC. Q Under 18 years, not recommended. D Not be used to treat AIDS-KS that may be treated effectively with local therapy or systemic a-interferon. Avoid pregnancy up to 6 months after discontinuation. Lactation. B Frequent ECG monitoring necessary. Impaired cardiac function (caution). Myelosuppression, sometimes life-threatening inf. reactions (discontinue immediately). Contains sucrose. C Caution: Anthracyclines, cytotoxic agents, especially myelotoxic. A Palmar-plantar erythrodysesthesia, stomatitis/mucositis, nausea, alopecia, rash, fatigue. Upper respiratory tract infection, BUSILVEX Pierre Fabre leukopaenia, anaemia, paresthesia, anorexia, GI disorders. See SPC. 2N Alkylating agent. Busulfan 6mg/ml; after dilution: CAMPTO Pfizer 0.5mg/ml. Concentrate for soln for inf. 2JN S Conditioning treatment prior to conventional haematopoietic progenitor cell Topoisomerase 1 inhibitor. Irinotecan (HCl transplantation (HPCT). Followed by trihydrate) 20mg/ml. Soln. in vials. 1 x 2ml; 1 x cyclophosphamide (BuCy2) in adults, and by 5ml; 1 x 15ml. Prices on request. cyclophosphamide (BuCy4) or melphalan (BuMel) S Advanced colorectal cancer, in in paediatric patients. combination with 5-fluorouracil and folinic acid in P 0.8mg/kg BW as a 2-hour inf. every 6 patients without prior chemotherapy; hours over 4 consecutive days for a total of 16 monotherapy in patients who have failed an doses. Followed by cyclophosphamide at 60mg/kg/ established 5-fluorouracil containing treatment day over 2 days initiated for a least 24 hours regimen. EGFR-expressing, KRAS wild-type following the 16th dose of Busilvex. Obese patients: metastatic colorectal cancer in combination with Use adjusted ideal BW (see SPC). cetuximab if no prior treatment for metastatic Q See SPC. disease or after failure of irinotecan-including D Pregnancy, lactation. cytotoxic therapy. 1st-line treatment of metastatic B Profound myelosuppression; monitor carcinoma of the colon or rectum in combination frequent complete blood counts, including with 5-fluorouracil, folinic acid and bevacizumab. differential white blood cell and platelet. 1st- line treatment of metastatic colorectal Prophylactic or empiric use of anti-infectives carcinoma in combination with capecitabine with during neutropenic period. Caution: Renal or without bevacizumab. impairment (monitor), hepatic impairement (if P Monotherapy: 350mg/m2 as an IV inf. severe, monitor serum transaminase, alkaline over 30-90 mins. every three weeks or 125mg/m2 phosphatase, bilirubin for one month), Fanconi as an IV inf. over 90 mins. for 4 consecutive weeks anemia, history of mediastinal or pulmonary followed by a 2 week rest. The weekly regimen is radiation, of seizures. Monitor cardiac function. suitable for patients who need closer follow up or Can impair fertility. Men advised not to father a who are at particular risk of severe neutropenia. child during and up to 6 months after and to seek Combination therapy: 180mg/m2 every 2 weeks by advice on cryo-conservation of sperm prior to IV inf. over 30-90 mins. followed by inf. with treatment. folinic acid and 5-fluorouracil. Other combinaisons, C Caution: Paracetamol, itraconazole. see SPC. A Myelosuppression, depression, dizziness, Q Not recommended. anxiety, insomnia, anorexia, hyperglycaemia, D Chronic IBD, bowel obstruction, serum electrolyte disorders, GI / cardiac / bilirubin q 3 x ULN, severe bone marrow failure, respiratory / renal and urinary disorders, cough, WHO performance status q 2, impaired renal rash, alopecia, back pain, myalgia, arthralgia, failure. Pregnancy (up to 3 months after therapy), fever, pain, headache, allergic reaction, oedema lactation. general, weight increase, hepatomegaly, jaundice. B Weekly monitoring of blood cells. Liver impairment (perform tests before each cycle), CAELYX Schering-Plough elderly. Antiemetic recommended before each treatment. Acute cholinergic syndrome (caution 2N with asthma). Interstitial pulmonary disease Anthracycline. Doxorubicin (HCl) in pegylated (monitor patients with risk factors). Contains liposomes 2mg/ml. Vial. 10ml, A581.64; 25ml, sorbitol. A1470.69. C St John’s Wort (contra). Avoid strong S Monotherapy for metastatic breast cancer, where there is increased cardiac risk. AIDS- CYP3A4 inhibitors/ inducers. Drugs with related Kaposi’s sarcoma. Advanced ovarian cancer anticholinesterase activity (caution). in women who have failed 1st-line platinum-based A Delayed diarrhoea, nausea, vomiting, constipation, neutropenia, anaemia, chemotherapy. In combination with bortezomib for progressive multiple myeloma in patients with thrombocyctopenia, dyspnoea, muscular contraction or cramps, paresthesia, reversible least one prior therapy and who had or are alopecia, transient increased liver function tests. unsuitable for bone marrow transplant. P Breast cancer/Ovarian cancer: 50mg/m2 CANTAXEL Clonmel once every 4 weeks by IV inf. AIDS-related KS: 2JN 20mg/m2 every two-to-three weeks. Multiple Hypercalcaemia: Initially, 2400-3200mg daily in divided doses between meals; should gradually be reduced to 1600mg daily. Moderate renal impairment: Half adult dose. Q Not recommended. D ccQ10ml/min. B Pregnancy, lactation. Monitor renal function and serum Ca++. Maintain adequate fluid intake. C Other bisphosphonates (contra). Aminoglycosides (caution). Simultaneous admin. of antacids, food, drugs containing iron. A GI disturbances (use divided dose), skin reactions, renal dysfunction. Reversible elevations of serum parathyroid hormone, creatinine, LDH and alkaline phosphatase.
326
Taxane. Paclitaxel 6mg/ml. Clear colourless or slightly yellow viscous soln for inf. in vial. 5ml, A18.85; 16.7ml, A61.10; 25ml, A88.95; 50ml, A177.89. S Ovarian cancer: 1st line treatment of advanced ovarian cancer or with residual disease (q1cm), in combination with cisplatin. 2nd line treatment of metastatic ovarian cancer where platinum therapy has failed. Breast cancer: Adjuvant treatment of node-positive breast carcinoma following anthracycline and cyclophosphamide (AC) therapy (as alternative to extended AC therapy). Initial treatment of locally advanced or metastatic breast cancer in combination with either anthracycline or trastuzumab (in patients over-expressing HER2 at a 3+ level when anthracycline is not suitable). As single agent, metastatic breast cancer where anthracycline has failed or is not suitable. Advanced non-small cell lung carcinoma (NSCLC): In combination with cisplatin where surgery and/ or radiation therapy not suitable. AIDS-related Kaposi’s sarcoma (KS) where liposomal anthracycline therapy has failed. P By IV infusion, repeated every 3 weeks (except for KS). Ovarian cancer, 1st line: 175mg/ m2over 3 hrs followed by cisplatin 75mg/m2, or 135mg/m2 over 24 hrs followed by cisplatin 75mg/ m2. Ovarian and breast cancer, 2nd line: 175mg/m2 over 3 hrs. Breast cancer, adjuvant: 175mg/m2 over 3 hrs, for 4 courses following AC therapy. Breast cancer, 1st line: With doxorubicin, 220mg/m2 over 3 hrs admin. 24 hrs after doxorubicin (50mg/m2). With trastuzumab, 175mg/m2 over 3 hrs starting day after 1st dose of trastuzumab, or immediately after subsequent dose of trastuzumab if well tolerated. NSCLC: 175mg/m2 over 3 hrs, followed by cisplatin 80mg/m2. KS: 100mg/m2 over 3 hrs every 2 weeks. Pretreat with corticosteroids, antihistamines and H2-antagonists; see SPC. Q Not applicable. D Patients with baseline neutrophils Q1,500/mm3 (Q1,000/mm3 for KS patients). Pregnancy (use contraception), lactation. KS: Serious uncontrolled infections. B Caution: Hepatic impairment (if severe, do not use). Discontinue if significant hypersensivity reactions occur. Monitor blood counts. May occur: Cardiac conduction abnormalities (monitor), hypotension, hypertension, bradycardia, peripheral neuropathy, pseudomembranous colitis, interstitial pneumonitis, severe mucositis (KS). Contains ethanol and macrogolglycerol ricinoleate. C Caution: Inducers or inhibitors of CYP3A4 or CYP2C8 (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, erythromycin, fluoxetine, gemfibrozil). Nelfinavir, ritonavir. A Infection (UTI, RTI), myelosuppression, neutropenia, anaemia, thrombocytopenia, minor hypersensitivity reactions, peripheral neuropathy, bradycardia, hypotension, GI disturbances, alopecia, arthralgia, myalgia, injection site reactions, severe elevation in AST and alkaline phosphatase.
CARBOPLATIN
Hospira
2NO Alkylating agent. Carboplatin 50mg, 150mg, 450mg, 600mg. Soln. 50mg-1, A24.34; 150mg-1, A73.01; 450mg-1, A219.03; 600mg-1, A292.04. S Advanced ovarian carcinoma of epithelial origin in first line therapy, second line therapy unless treatments have failed. Small cell
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
DISORDERS
B Caution: Severe hepatic/renal impairment. Hepatic damage may occur, discontinue if severe; monitor liver function especially in first 6 months. Monitor cardiac function in heart disease patients. Contains lactose. CARDIOXANE Novartis C Contra: Terfenadine, astemizole, cisapride. Caution: Ciclosporin, Ca++ channel 2J EDTA analogue. Dexrazoxane 500mg (as HCl salt). blockers, medicinal products that inhibit the oxidation process in the liver (e.g. cimetidine, Lyophilized powder for soln for inf. in vial. 1, ketoconazole), coumarin anticoagulants. A217.09. A Breast tenderness, gynaecomastia, GI S Prevention of cardiotoxicity in cancer disorders, hepatic changes, hot flushes, asthenia, patients receiving anthracycline-containing pruritus, dry skin, rash, maculopapular rash, chemotherapy. sweating, hirsutism, alopecia, diabetes mellitus, P Admin. by short IV inf. over 15 min, approx. 30 min prior to each anthracycline admin., weight gain, anaemia, dizziness, somnolence, oedema, general/pelvic pain, chills, decreased leaving 15 min between treatments. Use 20 x libido, erectile dysfunction, impotence. doxorubicin dose and 10 x epirubicin dose. Q Not recommended. CERUBIDIN sanofi-aventis D Risk of pregnancy, lactation. 2N B Monitor haematology regularly, particularly during 1st two cycles. Liver impairment Anthracycline. Daunorubicin (HCl) 20mg. Powder (monitor liver function), renal impairment. in vial. 1, A44.80. A Leukopenia, thrombocytopenia, inj. site S Remission in acute lymphatic and reactions. myelogenous leukaemia. V Under 2 years or Q 0.5 m2 body surface CASODEX AstraZeneca area, 1mg/kg/day; over 2 years, 40-60mg/m2 on alternate days for a course of up to 3 inj. Acute 2NT and acute lymphatic Anti-androgen. Bicalutamide 50mg. White film-ctd myelogenous leukaemia leukaemia, 45mg/m2 daily. tab. marked CDX50 and logo. 28, A77.96. D Non-malignant disease, acute infections, S Advanced prostate cancer in marked bone marrow suppression, oropharyngeal combination with LHRH analogue therapy or ulceration, chicken-pox, herpes zoster, surgical castration. P 1 daily commencing on day of initiation intramuscular or subcutaneously. B Monitor blood counts, uric acid, of LHRH analogue therapy or concomitantly with cardiotoxicity. Reduce by 25% if bilirubin 1.2-3mg/ surgical castration. 100ml and by 50% if bilirubin q3mg/100ml. Q Contraindicated. A Leucopenia, thrombocytopenia, GI D Women, children. B Moderate to severe hepatic impairment. disturbances, headache, allergic reactions, fever, weakness, alopecia, stomatitis, rash. Urine may be Consider periodic liver function tests. Discontinue if severe hepatic changes or hepatic failure occur. temporarily coloured red. Reduction in glucose tolerance may occur; CISPLATIN Hospira consider monitoring blood glucose. Contains 2NO lactose. C Contra: Terfenadine, astemizole, Alkylating cytotoxic. Cisplatin 10mg, 50mg, 100mg. cisapride. Caution: Ciclosporin, Ca++ channel Soln. in vials. 10mg-1, A15.05; 50mg-1, A22.47; blockers, other drugs which may inhibit drug 100mg-1, A34.79. S Management of neoplastic disease, oxidation (e.g. cimetidine, ketoconazole), metastic testicular tumours, refractory ovarian coumarin anticoagulants. carcinoma, bladder carcinoma, squamous cell A Anaemia, anorexia, decreased libido, carcinoma of head and neck. dizziness, somnolence, hot flush, GI disorders, V See lit. dyspepsia, flatulence, hepatic changes/ hepatoD Renal impairment, hearing impairment, biliary disorders, skin disorders, haematuria, myelosuppression. Pregnancy, lactation. gynaecomastia, breast tenderness, impotence, asthenia, chest pain, oedema, weight gain. carcinoma of the lung. D Severe myelosuppression, pre-existing severe renal impairment, history of severe allergies to carboplatin, other platinum containing compounds or mannitol.
NEOPLASTIC DISORDERS 20.1 History of CVD. Children and elderly (no data). C Caution: Previous (or concomitant) therapy with cardiotoxic drugs. A Fever, back pain, flushing, chest tightness, headache, fatigue, chills, mucous ulcerations, dizziness, nausea, vomiting, alopecia, stomatitis, bone marrow depression.
DECAPEPTYL SR
Ipsen
6NT Gn-RH analogue. Triptorelin 3mg. 5ml vial containing powder plus 2ml diluent. 1, A157.61. S Prostatic carcinoma. P 1 vial (3mg) as single IM inj. every 28 days. See SPC. Q Not recommended.
6NT ALSO DECAPEPTYL 3-MONTH Triptorelin 11.25mg. Powder in vial plus 2ml diluent. 1, A431.71. P 1 vial (11.25mg) as single IM inj. at 3 month intervals. See SPC. Q Not applicable. B See SPC. A Hot flushes, decreased libido, impotence, transient secondary neuropathy, inj. site erythema, rash, hair loss, GI disturbances, sweating, gynaecomastia, vertigo, transient hypertension, transient sight disturbances. See SPC.
DOXORUBICIN
Hospira
2NO Anthracycline. Doxorubicin 10mg, 50mg. Powder in vials 10mg-1, A19.20; 50mg-1, A94.71. S See SPC.
DROGENIL
Schering-Plough
2NT
Non-steroidal anti-androgen. Flutamide 250mg. Yellow scored tab. 84, A146.71. S Palliative treatment of advanced prostatic carcinoma, management of locally confined prostatic cancer (B2-C2, T2b-T4). P 250mg three times daily at 8 hour intervals. B Monitor liver function and spermatogenesis in patients without orchidectomy. Do not initiate if serum transaminase q2-3 X ULN. Cardiac disease (fluid retention may occur). Increased oestradiol may increase risk of thromboembolism. Patients with G6P deficiency may develop methaemoglobinaemia. Renal insufficiency, dose adjustment may be required. Elevated serum creatinine levels have been reported. CYTARABINE Hospira C Avoid: Hepatotoxic drugs, excessive CASOMIDE Clonmel 2 N O alcohol consumption. Anticoagulants, steroids, Nucleoside analogue. Cytarabine 100mg/ml, 2NT theophylline. 100mg/5ml, 1g/10ml. 100mg/1ml-5, A74.12; A Increased appetite, insomnia, diarrhea, Anti-androgen. Bicalutamide 50mg. White round 100mg/5ml-5, A74.71; 1g/10ml-1, A32.70. nausea, vomiting, gynecomastia and/or breast biconvex film-ctd tab. 28, A38.25. tenderness, galactorrhea, tiredness, transient S Advanced prostate cancer: In DAUNOXOME Gilead abnormal liver function and hepatitis. combination with LHRH analogue therapy or 2N surgical castration. Locally advanced prostate EFUDIX Meda cancer: Alone or as adjuvant therapy to radical Anthracycline. Daunorubicin (HCl) in liposomes 2NO prostactectomy or radiotherapy in patients at high 50mg (2mg/ml). Emuls. in vial. 1, A226.00. S AIDS-related Kaposi’s sarcoma in risk for disease progression. Nucleoside analogue. Fluorouracil 5%. Cream. 20g, patients with low CD4 cell counts (Q200cells/mm3) A19.26; 40g, A38.52. P Advanced prostate cancer: 50mg, once and extensive mucocutaneous or visceral disease. daily. Start treatment at least 3 days before S Superficial pre-malignant and malignant P 0,2mg-1mg/ml of soln. diluted with 5% skin lesions. Keratoses, Bowen’s disease, superficial treatment with LHRH analogue or same time as dextrose admin. IV over 30-60 mins. Initially, 40 surgical castration. Locally advanced prostate basal-cell carcinoma. cancer: 150mg once daily continuously for at least mg/m2 every two weeks. P Apply thinly once or twice daily to D Pregnancy, lactation. 2 years or until disease progression. lesion. Duration: Usually 3-4 weeks. D Females and children. History of hepatic B Risk of myelosuppression (monitor bone Q Not recommended. D Pregnancy, lactaction. marrow function). Frequent ECG monitoring. toxicity with bicalutamide. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
327
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
B Avoid: Eyes/mucous membranes. Excessive/extensive use may cause absorption. Lesions appearance may initially worsen prior to resolution. Use under medical direction only. Contains: Stearyl alcohol, propylene glycol, methyl/ propyl parahydroxybenzoate. A Transient erythema.
ELIGARD
C Sulphonylurea drugs, marrow depressant drugs, allopurinol, suxamethonium, concurrent radiotherapy or cytotoxic agents. A Anorexia, nausea and vomiting and mucosal ulceration, alopecia, acute sterile haemorrhagic cystitis.
Thiazide diuretics, enzyme inducers (eg. phenobarbital, phenytoin and carbamazepine), CYP3A4 inhibitors (see annexe). A Hot flushes, depression, sweating, rash, nausea, vomiting, leukorrhoea, dizziness, oedema, uterine bleeding, fatigue.
ERBITUX
FASLODEX
Merck Serono
Astellas 2 J N
6MT
Monoclonal antibody. Cetuximab 2mg/ml, 5mg/ml. Sln for inf. 2mg/ml-50ml vial; 5mg/ml-20ml and 100ml vials. Price on request. S Treatment of epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer, in combination with chemotherapy or as single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Treatment of locally advanced squamous cell cancer of the head and neck (SCCHN) in combination with radiation therapy. P Initially, 400mg/m2 body surface area by IV inf. over 120 mins. Then 250mg/m2 once a week by 60 min inf. Max infusion rate:10mg/min. Premedicate with antihistamine and corticosteroid prior to 1st inf; also recommended for subsequent ones. Colorectal: Concomitant chemotherapy must not be administered earlier than 1 hr after end of cetuximab infusion, see relevant SPC for dosage. Continue treatment until progression of underlying disease. SCCHN: Start therapy 1 week before radiation therapy; continue until end of radiation therapy period. Q Not recommended. D Known severe (grade 3 or 4) hypersensitivity reactions to cetuximab. Lactation (up to 2 months after last dose), pregnancy (unless benefit outweighs risk). B Mild or moderate hypersensitivity reaction. Reduced performance status, cardiopulmonary disease, haematological disorders, elderly. If interstitial lung disorders diagnosed, discontinue. Radiotherapy in colorectal cancer. A Headache, conjunctivitis, GI disorders, ENDOXANA Asta Medica skin reactions (e.g. acne-like rash, pruritus, dry skin, desquamation, hypertrichosis, nail disorders, 2NO necrosis), hypomagnesaemia, infusion-related Alkylating agent. Cyclophosphamide 200mg, 500mg, 1g. Powder in vial for reconstitution prior reactions, mild to moderate mucositis (may lead to epistaxis), fatigue, liver enzyme levels increased. to inj. 200mg-10, A16.29; 500mg-1, A2.86; 1g-1, A4.96. Orion S Malignant disease in adults, either alone FARESTON 5MO or in combination with other cytotoxic drugs, radiotherapy or surgery. Anti-oestrogen. Toremifene 60mg. White tab. P 80-300mg/m2 daily as single i.v. dose or marked TO60. 30, A34.31. divided oral doses. 300-600mg/m2 weekly as single S First line hormone treatment of 2 i.v. dose. Max. 600-1500mg/m as single i.v. dose hormone dependent metastatic breast cancer in or infusion given at 10-20 day intervals. postmenopausal patients. 2N P 1 daily ALSO ENDOXANA TABLETS Cyclophosphamide Q Not applicable. 50mg. White, round, bi-convex sug-ctd tab. 100, D Pre-existing endometrial hyperplasia, A9.21. severe hepatic failure, QT prolongation, electrolyte P See SPC. disturbances (eg. hypokalaemia), bradycardia, D Acute Infections, bone marrow aplasia, heart failure with reduced left-ventricular ejection UTIs, acute urothelial toxicity. Pregnancy, lactation. fraction, history of symptomatic arrhythmias. B Elderly, debilitated, diabetes, Pregnancy, lactation. myelosuppression. Cardiotoxicity reported with B Proarrhythmic conditions (especially in high doses. Not recommended if: Plasma elderly) eg. acute myocardial ischaemia or QT creatinine q 120mcM/L, bilirubin q 17mcM/L, prolongation; monitor for cardiac arrhythmia transaminases or alkaline phosphatase q x 2-3 (discontinue if occurs). Non-compensated cardiac normal value. Amenorrhoea and azoospermia insufficiency, severe angina, bone metastases, reported. Driving/using machines. Caution: severe thromboembolic disease (avoid), additional Reported drug-induced neoplasia. Monitor for risk of endometrial cancer, liver impairment. acute leukaemia and bladder cancer following C Contra: Drugs prolonging QT interval. therapy. Avoid warfarin-type anticoagulants. Caution:
GnRH analogue. Leuprorelin acetate 7.5mg, 22.5mg, 45mg. Powder and solvent for soln. for inj. 7.5mg, A232.04; 22.5mg, A500.32; 45mg, A882.05. S Hormone dependent advanced prostate cancer. P 7.5mg as single SC inj. monthly or 22.5mg every 3 months or 45mg every 6 months. Monitor clinical parameters and PSA level regularly thereafter. Do not discontinue when remission/improvement occurs. Q Not applicable. D Previous orchiectomy. As sole treatment in prostate cancer patients with spinal cord compression/evidence of spinal metastases. Women, paediatric patients. B 1st week, worsening/onset of new symptoms may occur. Consider additional admin. of antiandrogen 3 days prior to and first 2 or 3 weeks. Ureteral obstruction, spinal cord compression, decreased bone density; reported. Monitor: Patients with vertebral/brain metastases, urinary tract obstruction, diabetes. Driving/using machinery. A Nasopharyngitis, hot flushes, GI disorders, ecchymoses, erythema, pruritus, night sweats, arthralgia, limb pain, myalgia, renal/ urinary disorders, breast tenderness, testicular atrophy, testicular pain, infertility, breast hypertrophy, fatigue, injection site reactions, rigors, weakness, haematology changes, increased blood creatinine phosphokinase, prolonged coagulation time.
328
AstraZeneca
5NT Anti-oestrogen. Fulvestrant 250mg. 5ml soln. in pre-filled syringe. A507.88. S Postmenopausal women with oestrogen receptor positive, locally advanced or metastatic breast cancer for disease relapse on or after adjuvant antioestrogen therapy or disease progression on therapy with an antioestrogen. P 250mg at intervals of 1 month by IM inj. slowly into buttock. Q Children or adolescents, not recommended. D Severe hepatic impairment. Pregnancy, lactation. B Mild to moderate hepatic impairment. Severe renal impairment (cc Q30ml/min). Bleeding diatheses, thrombocytopenia or patients taking anticoagulant treatment. Risk of thromboembolic events and osteoporosis. A Hot flushes, inj. site reactions. GI disturbance incl. nausea, vomiting, diarrhoea and anorexia. Headache, asthenia, back pain, venous thromboembolism, UTIs, rash.
FEMARA
Novartis
5NO Aromatase inhibitor. Letrozole 2.5mg. Yellow round coated tab. marked FV on one side and CG on reverse. 30, A93.26. S Extended adjuvant treatment of hormone dependent early breast cancer in postmenopausal women having received 5 years of tamoxifen therapy. Treatment of hormone dependent advanced breast cancer in postmenopausal women (1st line or after relapse/ progression with antiestrogens). P 1 daily. Q Not applicable. D Premenopausal endocrine status. Pregnancy, lactation. B Severe renal or hepatic impairment. If risk of osteoporosis, assess BMD and monitor. C Caution: CYP2A6 and 2C19 substrates with narrow therapeutic index. A Increased sweating, hot flushes, fatigue, weight increase, appetite change, hypercholesterolaemia, headache, dizziness, GI disorders, alopecia, rash, oedema, myalgia, bone pain, arthralgia, arthritis, osteoporosis, bone fractures.
FIRMAGON
Ferring
2MT GnRH antagonist. Degarelix (as acetate) 80mg, 120mg. Powder and solvent for sln for inj. 80mg-1; 120mg-2. Prices on request. S Adult males with advanced hormonedependent prostate cancer. P Initially, 240mg as 2 SC inj. of 120mg each. Monthly maintenance dose: 80mg as 1 SC inj. 1st maintenance dose: 1 month after initial dose. For SC use only. Monitor clinical effect by clinical parameters and PSA serum levels. B Assess benefit vs risk: History of a corrected QT interval over 450msec, history of or risk factors for torsades de pointes. Caution:
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
film-ctd., very dark yellow to brownish-orange. 100mg-60, A1384.87; 400mg-30, A2769.74. S Patients with Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as first line treatment. Patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. Patients with Kit (CD 117) positive unresectable and/or metastatic malignant GI stromal tumours (GIST). P CML: 400mg/day for chronic phase CML. 600mg/day for accelerated phase or blast crisis. Dose increase to 600mg for chronic phase or 800mg for accelerated phase or blast crisis if no haematological response is seen after 3 months, or if disease progresses. Take with food and a large FLUDARA ORAL glass of water. GIST: 400mg/day for patients with unresectable and/or metastatic malignant GIST. 2NT GEMZAR Lilly Limited data exists on the effect of dose increases Nucleoside analogue. Fludarabine (phos.) 10mg. from 400-600mg in patients progressing at the 2JN Salmon-pink film-ctd cap.-shaped tab. marked lower dose. (see SPC). with LN in a hexagon one side. 15; 20. Prices Nucleoside analogue. Gemcitabine (HCl) equiv. Q Not applicable. available on request. 200mg or 1g gemcitabine. 200mg and 1g vials S B-cell chronic lymphocytic leukaemia containing powder for soln. for infusion. Prices on D Lactation. B Hepatic impairment. Severe fluid (CLL) with sufficient bone marrow reserve and request. who have not responded to or whose disease has S In combination with cisplatin for locally retention. Weigh patients regularly. Regular monitoring of complete blood counts and liver progressed during or after treatment with at least advanced or metastatic bladder cancer. Locally function tests. Cardiac disease. Should not be used one standard alkylating agent containing regimen. advanced or metastatic adenocarcinoma of the during pregnancy unless necessary. P 40mg/m2 body surface area given daily pancreas. In combination with cisplatin, as firstC CYP3A4 inhibitors, inducers or for 5 consecutive days every 28 days for 6 cycles. line treatment of locally advanced or metastatic substrates (see Appendix I), triazolo2N non-small cell lung cancer (NSCLC); monotherapy ++ can be considered in elderly patients or those with benzodiazepines, dihydropyridine, Ca channel ALSO FLUDARA IV Fludarabine (phos.) 50mg. blockers, certain HMG-CoA reductase inhibitors Powder for soln. in vial. 5, A950.63. performance status 2. Locally advanced or (i.e. statins), paracetamol, drugs being substrates S Initial treatment of B-cell chronic metastatic epithelial ovarian carcinoma, in of CYP2D6, warfarin. lymphocytic leukaemia (CLL) or after first line combination with carboplatin, in patients with A Headache, nausea, vomiting, diarrhoea, therapy, in patients with sufficient bone marrow relapsed disease following a recurrence-free reserve. interval of at least 6 months after platinum-based, dyspepsia, abdominal pain, fatigue, myalgia, muscle spasm and cramps, musculo-skeletal pain, P 25mg/m2 body surface area given daily first-line therapy. In combination with paclitaxel, joint swelling, periorbital oedema, dermatitis, rash, for 5 consecutive days every 28 days for 6 cycles. for unresectable, locally recurrent or metastatic fluid retention, neutropenia, thrombocytopenia, D Renal impairment, cc Q30ml/min. breast cancer in patients who have relapsed anaemia. Decompensated haemolytic anaemia. Pregnancy, following adjuvant/neoadjuvant chemotherapy; lactation. prior chemotherapy should have included an GONAPEPTYL DEPOT Ferring B See SPC. anthracycline unless clinically contra-indicated. 6NT P See SPC. FLUOROURACIL Hospira Q Not recommended. Gn-RH analogue. Triptorelin (acetate) 3.75mg. Powder and solvent for inj. prolonged release in 2NO D Pregnancy, lactation. pre-filled syringe. 1, A183.98. B Increased toxicity with prolongation of Nucleoside analogue. Fluorouracil 250mg/10ml; S Advanced, hormone-dependent prostate inf. time and increased dosing frequency. Bone 500mg/20ml; 500mg/10ml; 2.5g/100ml; 2.5g/50ml. carcinoma. marrow function suppression may occur; monitor Vials. 250mg/10ml-5, A41.18; 500mg/10ml-5, A63.67; 500mg/20ml-10, A65.88; 2.5g/100ml-1, P One syringe (3.75mg) SC or deep IM inj. prior to each dose for platelet, leucocyte, and A18.08; 2.5g/50ml, A43.58. every 28 days; change inj. site each time. granulocyte counts. Discontinue if serious pulmonary effects or microangiopathic haemolytic Q Not applicable. S Alone or in combination for palliative D Hormone independent prostate anaemia occur. Radiotherapy (toxicity and action in managment of common malignancies carcinoma. Sole treatment in prostate cancer radiation injury reported). May affect male particularly cancer of colon/breast. fertility. Caution: History of cardiovascular events, patients with spinal cord compression or evidence V See lit. D Non-malignant disease, patients of spinal metastases. After orchiectomy. hepatic insufficiency, impaired renal function. seriously debilitated or with bone marrow B Premonitory signs of medullary Contains Na+. depression after radiotherapy or treatment with C Not recommended: Yellow fever and compression. Urinary tract obstructions. Monitor other anti-neoplastic agents. Pregnancy, lactation. other live attenuated vaccines. prostate-specific antigen (PSA) and testosterone A Myelosuppresssion (anaemia, leucopenia during treatment. Allergic and anaphylactic FOLINIC ACID Hospira and thrombocytopenia), anorexia, febrile reactions reported. neutropenia. GI disorders, dyspnoea, cough, C Oestrogen. 2NO rhinitis, headache, somnolence, insomnia, rash, A Bone pain, libido decreased, hot flushes, Folic acid derivative. Folinic acid (Ca++ folinate) alopecia, back pain, myalgia, flu-like symptoms, dysuria, impotence, headache, perspiration. 3mg/ml, 15mg/2ml, 50mg/5ml, 100mg/10ml. Amps. oedema, fever, asthenia, chills, elevation of liver Hypersensitivity, depressive mood, irritability, A and vials. Amps.: 3mg/ml x 5, 6.35; 15mg/2ml x enzymes, mild proteinuria, haematuria. nausea, myalgia, arthralgia, tiredness, sleep 5, A21.58; Vials: 50mg/5ml x 1, A19.05; 100mg/ disorders, inj. site pain/reaction, gynecomastia. 10ml x 1, A37.97; 300mg/30ml x 1, A113.89. deficiency. V Calcium Leucovorin Rescue: Initiate 24 hrs after beginning of methotrexate inf. Usually, 15mg (approx. 10mg/m2) every 6 hrs for 10 doses, either parenterally by IM inj., bolus IV inj. or IV inf., or orally using tabs. Do not administer intrathecally. Ensure prompt excretion of methotrexate (see SPC). Folate Deficiency: Over 12 years, 10-20mg daily (usually 1 tab. daily); up to 12 years, 0.25mg/kg/day. D Treatment of pernicious anaemia/other megaloblastic anaemia where vit. B12 is deficient. B Lactation, pregnancy (only if benefit outweighs risk). C Do not admin. simultaneously with antineoplastic folic acid antagonist (e.g. methotrexate). Phenobarbitone, phenytoin, Genzyme primidone.
Known or suspected hepatic disorder (monitor liver function), severe renal impairment, diabetes. Long-term treatment may affect bone density. C Assess benefit vs risk: Medicinal products known to prolong the QTc interval or medicinal products able to induce torsades de pointes e.g. Class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, cisapride, moxifloxacine, antipsychotics. A Hot flush, inj. site adverse events. Anaemia, weight increase, insomnia, dizziness, headache, diarrhoea, nausea, increased liver transaminases, hyperhidrosis, rash, musculoskeletal pain, gynaecomastia, testicular atrophy, ED, chills, pyrexia, fatigue, flu-like illness.
2NO ALSO CALCIUM FOLINATE TABLETS Folinic acid (Ca++ folinate) 15mg. Light yellow scored tab. marked cf one side. 10, A48.27. S Reduce/counteract toxicity of folic acid antagonists eg. methotrexate (Calcium Leucovorin Rescue). Megaloblastic anaemias due to folate
GLIVEC
Novartis
2NT Tyrosine kinase inhibitor. Imatinib (mesilate) 100mg, 400mg. Round tab. with ’NVR’ on one side and scored on the other (100mg). Ovaloid, biconvex tab. with bevelled edges, debossed ’NVR’ on one side and ’SL’ on the other (400mg). Both
GRANOCYTE
Chugai
5NT Recombinant human granulocyte-colony stimulating factor, rHu G-CSF. Lenograstim. Powder in vial plus prefilled syringe with WFI. Granocyte-34: 33.6 MIU/vial. 5 x 1ml vial plus 5 x
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
329
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS A Fever, chills, abdominal pain, asthenia, chest pain, headache, diarrhoea, nausea, vomiting, anorexia, constipation, dyspepsia, dry mouth, arthralgia, myalgia, rash, allergic reaction, infection, pain, vasodilation, tachycardia, hypotension, heart failure, cardiomyopathy, palpitation, leucopenia, peripheral oedema, leg cramps, arthritis, anxiety, depression, dizziness, insomnia, asthma, cough, UTI.
S In combination with 5-fluorouracil (5FU) and folinic acid for: (a) adjuvant treatment of stage III (Dukeâ&#x20AC;&#x2122;s C) colon cancer after complete resection of primary tumour; (b) metastatic colorectal cancer. P 85mg/m2 as a 2-6 hour IV inf. in 250500ml of 5% glucose soln, repeated every 2 weeks. Duration in adjuvant setting: 6 months (12 cycles). D Myelosuppression or peripheral sensitive HOSPIRA GEMCITABINE Hospira neuropathy with functional impairment. Severe renal impairment. Lactation, pregnancy 2JN Nucleoside analogue. Gemcitabine (as HCl) 200mg, (contraception recommended up to 4 months 1g, 2g. 200mg, 1g and 2g vials containing powder after therapy for women and 6 months for men). B Use only in specialised oncology for soln. for infusion. Prices available on request. departments. Moderate renal impairment. History S Locally advanced or metastatic bladder of allergic reaction to platinum compounds. If cancer in combination with cisplatin. In oxaliplatin extravasation occurs stop inf. Perform combination with paclitaxel, for locally advanced neurological examination before admin. and or metastatic breast cancer in relapsed disease periodically thereafter. If acute laryngopharyngeal following adjuvant/ neoadjuvant chemotherapy dysaesthesia develops with 2-hour inf., admin. including an anthracycline. Locally advanced or next inf. over 6 hours. If neurological symptoms metastatic non-small cell lung cancer (in occur, adjust dose, see SPC. If haematological combination with other cytostatics or paliative toxicity occurs postpone next course until normal treatment as single agent). Locally advanced or levels return. Perform full blood count before each metastatic adenocarcinoma of the pancreas in course. Reduce dose if grade 4 diarrhoea, grade 3patients with good general condition and 4 neutropenia or thrombocytopenia. adequate bone marrow reserves. A Infection, rhinitis, upper RTI, blood and 2 P NSCLC: Single agent use: 1000mg/m by lymphatic disorders, allergic reaction, anorexia, IV inf. over 30 min. once weekly for 3 weeks hyperglycaemia, hypokalaemia, hyponatremia, followed by a week of rest. Repeat cycle. dehydration, depression, insomnia, peripheral Combination use: Either gemcitabine 1250mg/m2 sensory neuropathy, sensory disturbance, given by IV inf. over 30 min. on days 1 and 8 of each 21 day cycle or gemcitabine 1000mg/m2 by IV dysgeusia, headache, dizziness, motor neuritis, meningism, conjunctivitis, vision abnormal, infusion over 30 min. on days 1,8,15 of each 28 haemorrhage, flushing, DVT, dyspnoea, coughing, day cycle. Cisplatin dose range: 75-100mg/m2 once epistaxis, pulmonary embolism, hiccups, GI 2 every 3 or 4 weeks. Pancreatic cancer: 1000mg/m disorders, skin and SC tissue disorders, alopecia, by IV inf. over 30 min. once weekly for 7 weeks pain (chest/back/bone), arthralgia, dysuria, followed by a week of rest. Subsequent cycles, micturition disorder, haematuria, fatigue, fever, once per week for 3 out of every 4 weeks. Bladder asthenia, pain, inj. site reaction. cancer: 1000mg/m2 by IV infusion over 30 min. on days 1,8,15 of each 28 day cycle and cisplatin HOSPIRA PACLITAXEL Hospira 70mg/m2 on day 1 following gemcitabine on day 2N 2. Breast cancer: Paclitaxel 175mg/m2 on day 1 Taxane. Paclitaxel 6mg/ml. Soln. for infusion in over approx. 3 hours as IV inf., followed by gemcitabine 1250mg/m2 as 30 min. IV inf. on days vials. 30mg/5ml, A155.00; 100mg/16.7ml, A465.00; 150mg/25ml, A696.50; 300mg/50ml, A1393.00. HERCEPTIN Roche 1 and 8 of each 21 day cycle. Adjust dose S Advanced AIDS-related Kaposiâ&#x20AC;&#x2122;s sarcoma according to blood counts (see SPC). 2N (KS) when liposomal anthracycline therapy has Q Not recommended. failed. Metastatic carcinoma of the breast (MBC) Monoclonal antibody. Trastuzumab 150mg. D Pregnancy, lactation. when standard anthracycline-containing therapy Powder for soln. for inf. in vial. 1 vial. Price on B Prolongation of inf. time, increased request. dosing frequency (increase toxicity). Compromised has failed or is inappropriate. Metastatic carcinoma of the ovary (MOC) after failure of S Treatment of patients with metastatic bone marrow function. Monitor thrombocyte, platinum-containing combination therapy without breast cancer whose tumours overexpress HER2 leucocyte and granulocyte counts prior to each taxanes. (see SPC). Treatment of HER2 positive early breast dose. Impaired hepatic/renal function (check P KS: 100mg/m2 as 3-hour IV inf. every cancer following surgery, chemotherapy periodically). Serious pulmonary effects, (neoadjuvant or adjuvant) and radiotherapy. two weeks. MBC/MOC: 175mg/m2 as 3-hour IV inf. microangiopathic haemolytic anaemia P Initial loading dose: 4mg/kg body every three weeks. Adjustment during treatment, (discontinue). weight followed by weekly dose of 2mg/kg body see SPC. Severe neutropenia, peripheral C Contra: Yellow fever vaccine. Caution: weight beginning one week after loading dose. neuropathy or mucositis, reduce dose by 25%. Radiotherapy (risk of oesophagitis, pneumonitis, Doses should be administered as a 90-minute IV Q Under 18 years, not recommended. colitis), ciclosporin, tacrolimus. Avoid live inf. Observe patients for at least 6 hours after the D Severe hepatic impairment. Baseline attenuated vaccines and phenytoin. first inf. and for 2 hours after the start of neutropenia Q1000 cells/mm3 (KS) or Q1500 cells/ A Myelosuppression, incl. leucopenia, subsequent inf. for symptoms (fever, chills, other mm3 (MBC and MOC). Serious, uncontrolled thrombocytopenia, neutropenia. Anorexia, infusion-related symptoms). Interruption of inf. infections. Pregnancy, lactation. headache, somnolence, insomnia, GI disorders, may help control such symptoms, inf. may be B Perform frequent complete blood dyspnoea, cough, rhinitis, rash, alopecia, sweating, resumed when symptoms abate. counts. Premedication with corticosteroid, itching, myalgia, back pain, fever, asthenia, facial Q Under 18 years, not recommended. antihistamine, and H2-receptor antagonist required oedema. Elevation of liver enzymes, mild D Severe dyspnoea at rest due to (see SPC). Severe hypersensitivity reactions, proteinuria/ haematuria. complications of advanced malignancy or discontinue. Cardiac conduction abnormalities and requiring supplementary oxygen therapy. arrhythmias (monitor signs). Contains polyoxyl HOSPIRA OXALIPLATIN Hospira Lactation. castor oil and ethanol. 2 J N B Monitor for cardiotoxicity and inf. C Caution: Inhibitors or inducers of Alkylating agent. Oxaliplatin 5mg/ml. Soln: 10ml, reactions. Pulmonary events (dyspnoea, CYP3A4 and 2C8. bronchospasm, asthma, hypoxia) can occur as part 20ml, 40ml. Powder: 50mg, 100mg - price on A Bone marrow suppression. request. of inf. reaction. Pregnancy. Hypersensitivity reaction. Vasodilatation,
1ml pre-filled syringe WFI or inf. Granocyte-13: 13.4 MIU/vial. 5 x 1ml vial plus 5 x 1ml pre-filled syringe WFI or inf. Price available on request. S Non-myeloid malignancy: reduction in duration of neutropenia and associated complications following bone-marrow transplantation or following treatment with cytotoxic chemotherapy associated with significant incidence of febrile neutropenia. Granocyte may be admin. to patients with de novo acute myeloid leukaemia aged above 55 years. Mobilisation of peripheral blood progenitor cells (PBPCs). P Cytotoxic-induced neutropenia: 150mcg/ m2/day (equiv. 5mcg/kg/day) by SC inj. started on day after completion of chemotherapy, continue until neutrophil count stable in acceptable range (max. 28 days). Bone marrow transplantation: 150mcg/m2/day (equiv. 5mcg/kg/day) by IV inf. started on day after completion of chemotherapy; continue until stable in acceptable range (max. 28 days). Mobilisation of PBPCs used alone: 10mcg/kg/ day daily for 4-6 days by SC inj. following adjunctive myelosuppressive chemotherapy 5mcg/ kg/day by SC inj. started on day after completion of chemotherapy until neutrophil count in acceptable range. For timing of leukapheresis consult lit. Q Over 2 years, cytotoxic-induced neutropenia 150mcg/m2/day (equiv. 5mcg/kg/day by SC inj. started on day after completion of chemotherapy, continue until neutrophil count stable in acceptable range (max. 28 days). Bone marrow transplantation 150mcg/m2/day (equiv. 5mcg/kg/day) by IV inf. started on day after completion of chemotherapy continue until stable in acceptable range (max. 28 days). D Myeloid malignancy. De novo acute myeloid malignancy aged below 55 years and/or with good cytogenics. B Myelodysplasia, severe hepatic or renal impairment. Monitor for leucocytosis, pulmonary adverse effects graft vs host disease in BMT. Pregnancy, lactation. C Cytotoxic drugs. A Bone pain, headache.
330
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
Q Not applicable. D Leucopenia, thrombocytopenia, severe anaemia. Non-malignant disease. Pregnancy, lactation (unless benefit outweighs risk). Adequate contraception required for both male and females before and during treatment. B Caution: Renal dysfunction, elderly, long term therapy. Monitor: Blood count, kidney and HYCAMTIN GSK liver function (prior and during treatment), uric acid levels. Maintain a high fluid intake. Driving/ 2N Topoisomerase I inhibitor. Topotecan 4mg. Powder operating machinery. C Previous or concomitant radiotherapy or in vial. 1. Price on request. cytotoxic therapy may potentiate activity. S Metastatic ovarian cancer where other Antiretroviral agents (e.g. didanosine, stavudine, therapies have failed. indinavir). P 1.5mg/m2 daily by IV inf. over 30 mins. A Bone-marrow suppression, leucopenia, for 5 consecutive days. Repeat every 3 weeks. thrombocytopenia, anaemia. Q Not recommended. tachycardia, bradycardia, syncope. Neuropathy, paraesthesia, somnolence, dizziness, nervousness, insomnia, depression, hypaesthesia. Arthralgia, myalgia, bone pain, leg cramps. Hepatobiliary disorders, GI disorders, dyspnoea, tinnitus, oedema, inj. site reactions, alopecia, skin disorders, asthenia, pain, taste perversion, headache.
2T ALSO HYCAMTIN CAPSULES Topotecan 0.25mg, 1mg. Resp. opaque white to yellowish white or opaque pink hard cap. marked with HYCAMTIN and strength. 0.25mg-10; 1mg-10. Prices on request. S Monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not appropriate. P Recommended dose: 2.3mg/m2 body surface area/day administered for 5 consecutive days with a 3 week interval between the start of each course. See SPC. Q Not recommended. D Pregnancy (use contraception), lactation. Severe bone marrow depression. B Haematological toxicity, blood count regularly. Administer under supervision of physician experienced in chemotherapy. May occur: Severe myelosuppression, incl. myelosuppression leading to sepsis and fatalities due to sepsis, neutropenic colitis, clinically relevant thrombocytopenia (caution in patients at increased risk of tumour bleeds), severe diarrhoea (particularly in elderly patients). Not recommended: Severely impaired renal function. C Inhibitors of ABCB1 and ABCG2, cyclosporin A, platinum agents (cisplatin or carboplatin). A Febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leucopenia, pancytopenia, GI disturbances, alopecia, pruritis, anorexia, infection, sepsis, fatigue, asthenia, pyrexia, malaise, hypersensitivity reaction including rash.
HYDREA
BMS
2NO DNA reactive cytotoxic. Hydroxycarbamide 500mg. Green/pink cap. marked BMS 303. 100, A13.91. S Malignant neoplastic disease incl. chronic myeloid leukaemia. Cancer of the cervix and other solid type tumours in conjunction with radiotherapy. P Start 7 days before irradiation therapy. Evaluate antineoplastic effect after 6 weeks. Significant response: Continue indefinitely under observation. Interrupt if WBCs (WBC)Q 2.5x109/L or platelet count Q 100x109/L. Continuous (suitable for chronic myeloid leukaemia): 20-30mg/ kg daily in single doses. Based on actual or ideal weight, whichever less. Intermittent (solid type tumours): 80mg/kg in single doses every third day. If low WBC produced, omit 1 or more doses. Use with other myelosuppressive agents may require dose adjustments.
tinnitus, vertigo, palpitation, tachycardia, hypertension, weight decrease. See SPC.
KEPIVANCE
Biovitrum
2J
Human keratinocyte growth factor. Palifermin 6.25mg (5mg/ml reconstituted). Powder for inj. in 6.25mg vials. 6, A4800. S Oral mucositis in patients with haematological malignancies receiving myeloablative therapy associated with severe mucositis and requiring autologous haemopoietic stem cell support. P 60mcg/kg/day as IV bolus inj. for 3 consecutive days before and 3 consecutive days after myeloablative therapy. 3rd dose 24-48 hrs before myeloablative therapy; 1st of last 3 doses after, but on same day of haematopoietic stem INTRONA Schering-Plough cell inf. and min. 4 days after most recent 2NT Kepivance admin. Single-subtype recombinant interferon. Interferon Q Children and adolescents, not recommended. alpha-2b (rbe) 10 MIU. Powder in vial plus WFI. 1 D Hypersensitivity to E. coli-derived syringe, 2 needles, 1 cleansing swab. 1, A77.48. proteins. Pregnancy (unless clearly necessary), 2NT ALSO INTRONA MULTIDOSE VIALS Interferon alfa- lactation. B Cytotoxic chemotherapy (admin. 24 hrs 2b (rbe) 10 MIU/ml (2.5ml). Plus syringe kits apart). Long-term treatment (limited data). containing syringe, needles, sterets and plasters. Hepatic impairment, elderly (no data). 10 MIU/ml-1 x 2.5ml, A190.23. A Taste perversion, mouth/tongue 2NT thickness or discolouration, rash, pruritus, ALSO INTRONA MULTIDOSE INJECTION PENS 18 erythema, arthralgia, oedema, pain, fever. MIU (15 MIU/ml), A139.47; 30 MIU (25 MIU/ml), A232.44; 60 MIU (50 MIU/ml), A464.88. LANVIS GSK S Chronic hepatitis B and C, hairy cell and 2NO chronic myeloid leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumours, malignant Guanine analogue. Thioguanine 40mg. Pale greenyellow circular tab. marked WELLCOME U3B on melanoma. one side and a score line on the other. 25, V See SPC. A43.24. D History of severe pre-existing cardiac S Acute myeloblastic leukaemia and acute disease. Severe renal/hepatic dysfunction. Epilepsy, lymphoblastic leukaemia. Also used in the compromised CNS. Chronic hepatitis with treatment of chronic granulocytic leukaemia. decompensated cirrhosis or in patients being or V 60-200mg/m2 body surface area per day. have been treated recently with D Non-malignant disease. Pregnancy, immunosuppressives excluding short term corticosteroid withdrawal. Autoimmune hepatitis; lactation. B Not recommended for maintenance or or history of autoimmune disease; long term therapy. Regularly monitor blood cell immunosuppressed transplant recipients. counts and liver function tests. Myelosuppressant: Uncontrolled pre-existing thyroid disease. Severe Monitor during therapy. Lesch-Nyhan syndrome; psychiatric conditions (or history of) in children. monitor for resistance. Pregnancy, lactation. C Not recommended: Live organism B Caution: History of pulmonary disease, vaccinations. Allopurinol. Caution: diabetes prone to ketoacidosis, coagulation Aminosalicylates. disorders, severe myelosuppression, psoriasis/ A Bone marrow suppression, stomatitis, GI sarcoidosis, patients predisposed to autoimmune disorders, adults with severe psychiatric conditions. intolerance, liver toxicity. Monitor for psychiatric disorders. Monitor if liver function abnormalities develop. Hypotension may occur. Ensure adequate hydration. Monitor: History of CHF, MI, arrhythmic disorders. Driving or using machinery. See SPC. C Ribavirin, see SPC. Caution: Narcotics, hypnotics, sedatives, other potentially myelosuppressive agents, xanthine derivatives, shosaikoto (Chinese herbal medicine), other chemotherapeutics. A Infections, anorexia, hyperuricemia, hypocalcemia, thirst, dehydration, psychiatric disorders, nervous system disorders, cough, dyspnoea, epistaxis, respiratory disorder, GI disorders, Hyper/hypo thyroidism, arthralgia, musculoskeletal pain, arthritis, inj site reaction, fatigue, flu-like symptoms, irritability, skin and SC tissue disorders, eye disorder, micturition frequency, reproductive/breast disorders, chest pain, hepatomegaly, blood/lymphatic disorders,
LEUKERAN
GSK
2NO Alkylating agent. Chlorambucil 2mg. Brown filmctd tab. marked GX EG3 one side and L on reverse. 25, A7.96; 50, A18.72. S Treatment of Hodgkin’s disease; certain forms of non-Hodgkin’s lymphoma; chronic lymphocytic leukaemia; Waldenstrom’s macroglobulinaemia. P Hodgkin’s disease: 0.2mg/kg/day for 4-8 weeks. Non-Hodgkin’s lymphoma: Initially 0.10.2mg/kg/day for 4-8 weeks. Maintenance therapy; reduced dose or intermittent doses. Chronic lymphocytic leukaemia: Initially 0.15mg/kg/day until total leucocyte count is 10,000/mcl. Resume 4 weeks after end of first course at 0.1mg/kg/day. Waldenstrom’s macroglobulinaemia: Starting dose 6-12mg daily until leucopenia occurs, followed by 2-8mg daily indefinitely.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
331
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
D Non-malignant disease. Pregnancy, lactation. B Check blood counts regularly. Caution: Patients with depressed bone marrow function, hepatic/renal impairment, patients with intolerance to some sugars (contains lactose). May cause mutagenicity and carcinogenicity. C Live organism vaccinations, phenylbutasone. A Acute 2o haematologic malignancies, leucopenia, neutropenia, thrombocytopenia, panyctopenia, anaemia, seizures in children with nephritic syndrome. GI disturbances.
B Thrombophlebitis. first-line treatment of metastatic cancer in women. A Weight gain, nausea, vomiting, oedema, NAVELBINE ORAL Pierre Fabre breakthrough uterine bleeding, urticaria.
METHOTREXATE
Goldshield
2NO
Folic acid antagonist. Methotrexate 2.5mg. Yellow tab. marked 2.5 one side, scored and marked MI on reverse. 28, A3.49. S Acute leukaemia, carcinoma. Severe, active rheumatoid arthritis, psoriasis unresponsive to other therapy. P Varies according to malignant condition. RA: 7.5mg once weekly or 2.5mg at 12 hourly MABCAMPATH Genzyme intervals for 3 doses as a course once weekly. Max 2N 20mg weekly. Psoriasis: 10-25mg orally once a week. Monoclonal antibody. Alemtuzumab 10mg/ml. Amp. containing conc.for soln. for inf. 3, A1579.78. METHOTREXATE INJECTION S Chronic Lymphocytic Leukaemia (CLL) Hospira previously treated with alkylating agents and 2N refractory or relapsed within 6 months following Folic acid antagonist. Methotrexate 5mg, 50mg, fludarabine therapy. 500mg, 1g, 5g. Vials. 5mg- 5x2ml (GMS), A25.50; P Escalate dose from 3mg to 30mg over 350mg-5x2ml, A30.50; 500mg-1x20ml, A42.47; 1g7 days or until tolerated. Then 30mg daily, 3 times 1x10ml, A49.50; 5g-1x50ml, A228.60. weekly on alternate days to max. of 12 weeks. D Active systemic infections, HIV MITOXANA Asta Medica infections, active secondary malignancies. 2NO Pregnancy, lactation. Alkylating agent. Ifosfamide 500mg, 1g, 2g. B See SPC. Powder in vials for inf. or inj. 500mg-1, A6.41; 1gMABTHERA Roche 1, A20.96; 2g-1, A38.73. S Malignant disease, either alone or in 2N combination with other cytotoxic drugs, Monoclonal antibody. Rituximab 10mg/ml. Soln. in radiotherapy or surgery. vial. 2x10ml, A653.14; 1x50ml, A1632.79. P 8-12g/m2 daily as a single dose over 3-5 S Relapsed or chemoresistant stage III-IV days every 2-4 weeks. IV inf: 5-6g/m2 as a 24 hour follicular lymphoma. See SPC. inf. every 3-4 weeks. Max. 10g. P 375mg/m2 IV infusion weekly for 4 D Bone marrow aplasia, myelosuppression, weeks. Initial rate: 50mg/hr for 30 mins. increasing urinary tract obstruction, acute infections incl. to max 400mg/hr as tolerated. Subsequent UTIs, urothelial toxicity, renal/hepatic impairment, infusions: 100mg/hr for 30 mins. increasing to max. serum transaminases or alkaline phosphatase q x 400mg/hr as tolerated. 2.5 normal range. Pregnancy, lactation. Q Not recommended. B Elderly/debilitated, diabetes, D Lactation, pregnancy (unless benefit myelosuppression. Correct electrolyte imbalances outweighs risk). before initiation. Patients after platinum therapy B Patients with high tumour burden, or nephrectomy. Children, increased renal history of CVD, cardiotoxic chemotherapy. damage. Monitor immunosuppressant effects. Monitoring of blood count. Amenorrhoea, azoospermia, mutagenicity, A Inf. related symptoms-may need to teratogenicity, carcinogenicity and drug-induced temporarilly interrupt infusion. Anaphylactic, neoplasia reported. Driving/using machines. hypersensitiviy reactions. Hypotension. C Anticoagulants. Other cytostatics or MEGACE ORAL SUSPENSION BMS radiation. Antidiabetics, allopurinol, nephrotoxics, barbiturates, CYP450 inducers. 2NO A Urothelial toxicity, nephrotoxicity, bone Progestogen. Megestrol acetate 40mg/ml. 240ml, marrow toxicity, GI disorders, alopecia, stomatitis, A120.62. dermatitis, gonadal function impairment, S Treatment of anorexia or weight loss hypersensitivity reactions, polyneuropathy, secondary to cancer or AIDS in male and female pneumonitis, impaired vision, increased reaction to patients. radiation. P 400-800mg (in 10-20ml) as single daily dose. Continue for at least 2 months. MYLERAN GSK Q Not recommended.
2NO ALSO MEGACE Megestrol acetate 40mg, 160mg. Off-white oval scored tab. marked 160. 40mg-120, A35.48, 160mg-30, A34.10. S Certain hormone dependent neoplasms (e.g. endometrial or breast carcinoma). P Breast carcinoma, 160mg daily in single or divided doses. Endometrial carcinoma, 40320mg daily in divided doses. Both for min. period of 2 months. Q Not applicable. D Pregnancy, lactation.
332
2NT Vinca alkaloid. Vinorelbine 20mg, 30mg. Light brown and pink soft caps. marked N20 and N30, resp. 20mg-1, A65.93; 30mg-1, A98.89. S Non small cell lung cancer, advanced breast cancer stage 3 and 4. P As single agent: Beyond 3rd admin. at 60mg/m2 escalate dose to 80mg/m2 once weekly in the absence of severe neutropenia. Delay dose if at any time blood test reveals grade 2, 3 or 4 neutropenia or thrombocytopenia . In combination: See SPC. Max: 160mg/week regardless of BSA. Q Not recommended. D Disease affecting absorption. Surgical resection of stomach or small bowel. Neutrophil count Q 1500/mm3 or severe infection (within 2 weeks). Severe hepatic insufficiency not related to tumoural process. Karnofsky performance status Q70%. Pregnancy. Lactation. Long term oxygen therapy. Concomitant radiotherapy including the liver. B If contact with liquid content of caps. occurs, wash thoroughly with saline soln. Determine Hb level, leucocyte, neutrophil and platelet counts on day of each new admin. Investigate signs of infection promptly. r grade 3 peripheral neuropathy or r grade 3 abnormality of liver function tests, delay until recovery. History of ischemic heart disease (caution). Primary prophylaxis with antiemetics recommended. C Caution: Cisplatin, strong CYP3A4 inhibitors. Morphine, use laxatives and monitor bowel motility. A Bacterial, viral or fungal infections, bone marrow depression resulting in neutropenia, fever, insomnia, neurosensory/visual disorders, hypotension, hypertension, dyspnoea, cough, GI disorders, oesophagitis, transient elevation of liver function tests, hepatic disorders, alopecia, skin reactions, arthralgia, myalgia, dysuria, fatigue, pain, weight change.
NEORECORMON
Roche
5NT
Recombinant human erythropoietin. Epoetin beta 10000 IU, 20000 IU, 30000 IU. Pre-filled syringes: 10000 IU-6, A727.94; 20000 IU-6, A1455.80; 30000 IU-4, A1237.48. S Prevention and treatment of anaemia in adult patients with solid tumours treated with platinum-based chemotherapy. Treatment of anaemia in adult patients with multiple myeloma, non-Hodgkinâ&#x20AC;&#x2122;s lymphoma or chronic lymphocytic leukaemia with low serum erythropoietin. P Solid tumours and haematological malignancies, by SC inj. initially 450 IU/kg per week; may be doubled after 4 weeks if patient does not show satisfactory Hb values. Continue 2N therapy for up to 3 weeks (solid tumours) or 4 Alkylating agent. Busulphan 2mg. White film-ctd weeks (haematological tumours) after end of tab. marked M one side and GXEF3 on reverse. chemotherapy. 100, A23.36. D Uncontrolled hypertension. For S Chronic granulocytic leukaemia. increasing yield of autologous blood if the month preceding treatment the patients have suffered MYOCET Cephalon MI, stroke, have unstable angina, are at risk of 2N DVT. Anthracycline. Doxorubicin (hydrochlor. liposome- B Hypertension, thrombocytosis. History of encapsulated citrate complex) 50mg. Inf. Vials. epilepsy. Chronic hepatic failure. Correct other Price available on request. causes of anaemia; iron suppl. may be necessary. S Combination with cyclophosphamide, Monitor Hb, BP, platelet count, serum electrolytes.
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
Limit Hb rise to Q2g/dL per month. Theoretically could stimulate malignant growth. Neonates (except NeoRecormon 500). Pregnancy, lactation. A Hypertension, shunt thrombosis, anaphylactoid reaction, increased platelets.
neutropenia, 0.5 MU SC; as single inj. or in divided doses. Continue until NC at q1.5 x109/L, ascertain min. required to maintain. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average NC between 1.5 x 109/L and 10 x 109/L. Severe infections, NEULASTA Amgen consider faster dose escalation; long-term safety of q 2.4MU daily not established. 5NT B Myelodysplastic syndrome, chronic Recombinant human granulocyte colony myelogenous leukaemia. Sickle cell disease; stimulating factor (G-CSF). Pegfilgrastim 6mg/ caution. Monitor for leukocytosis, osteoporosis, 0.6ml. Pre-filled syringe. 1, A1212.00. pulmonary symptoms, splenomegaly. Contains S Reduction in the duration of neutropenia and incidence of febrile neutropenia sorbitol. Pregnancy (only if benefit outweighs risk), lactation. Needle cover of pre-filled syringe in patients treated with cytotoxic chemotherapy contains dry natural rubber. Increased for malignancy with the exception of chronic myeloid leukaemia, myelodysplastic syndrome and haematopoietic activity of the bone marrow has been associated with transient positive bonesecondary acute myeloid leukemia (AML). P 6mg SC inj. for each chemotherapy cycle imaging findings. A Musculo-skeletal pain, reversible 24 hours after cytotoxic chemotherapy. increase in liver enzymes and serum uric acid, Q Under 18 years, not recommended. transient hypotension, rarely allergic-type D Pregnancy, lactation. reactions, cutaneous vasculitis, proteinuria, B Caution: Patients with AML, sickle cell haematuria. disease. If preliminary signs of ARDS appear, discontinue. Splenic rupture. Monitor platelet Bayer Schering count and haematocrit. Needle cover contains dry NEXAVAR 2NT natural rubber (may cause allergic reactions). Interpreting bone-imaging results: Consider Tyrosine kinase inhibitor. Sorafenib (as tosylate) increased haematopoietic activity of bone marrow 200mg. Red, round, biconvex film-ctd tabs., in response to growth factor therapy. Contains debossed with Bayer cross on one side and 200 on sorbitol, Na+ acetate. other. 112, price on request. C Admin. 24 hours after cytotoxic S Hepatocellular carcinoma. Advanced chemotherapy. renal cell carcinoma in patients who have failed A Skeletal pain, inj. site pain, chest pain prior interferon-a or interleukin-2 based therapy (non-cardiac), pain, headache, arthralgia, myalgia. or are considered unsuitable for such therapy. P 400mg twice daily. Admin. without food NEUPOGEN Amgen or with a low or moderate fat meal, with a glass of water. 5NT Q Not recommended. Recombinant human granulocyte colony D Lactation. stimulating factor (G-CSF). Filgrastim 30 MU/ml. Liquid in single dose vial. 30 MU-5 x 1ml, A521.75. B Monitor BP regularly. Risk of haemorrhage. Discontinue if: Cardiac ischemia/ 5NT infarction develop; severe dermatological toxicities ALSO NEUPOGEN SINGLEJECT Filgrastim 30 MU, occur. Severe hepatic impairment. Warfarin co48 MU per 0.5ml. Pre-filled syringes. 30 MU-5 x admin.: Monitor for changes in prothrombin time, 0.5ml, A597.73. 48 MU-5 x 0.5ml. A953.13. INR or clinical bleeding episodes. Major surgical S Reduction in duration of neutropenia procedures. Elderly (renal function). High-risk and incidence of febrile neutropenia after patients. Pregnancy (unless benefit outweighs established cytotoxic chemotherapy; reduction in risk). duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. C Caution: Rifampicin, St. John’s wort, Long term treatment to increase neutrophil counts phenytoin, carbamazepine, phenobarbital, dexamethasone, warfarin, phenprocoumon, (NC) and reduce incidence and duration of bupropion, cyclophosphamide, efavirenz, infection-related events in patients with severe ifosfamide, methadone, paclitaxel, amodiaquine, congenital, cyclic or idiopathic neutropenia and repaglinide, UGT1A1/UGT1A9 substrates, digoxin, history of severe or recurrent infections. doxorubicin, irinotecan. Antacids, H2-antagonists Mobilisation of peripheral blood progenitor cells or PPIs, no data. (PBPCs). HIV associated neutropenia . A Lymphopenia, blood disorders, V Established cytotoxic chemotherapy: hypophosphataemia, anorexia, depression, 0.5MU daily IV or SC 24 hrs after therapy. Bone neuropathy, tinnitus, haemorrhage, hypertension, marrow transplantation: Initially 1MU daily, as 30 mins. or 24 hr IV inf. or 24 hr SC inf. within 24 hrs. hoarseness, GI disorders, alopecia, skin and SC tissue disorders, arthralgia, myalgia, erectile Both uses: Titrate against neutrophil response dysfunction, fatigue, pain, asthenia, fever, flu like once nadir passed. Mobilisation of PBPCs: Alone, illness. 1MU daily SC as 24 hr inf. or single inj. for 5-7
days. Leukapheresis: 1 or 2 on days 5 and 6. Following myelosuppressive chemotherapy: 0.5MU SC daily from day 1 post therapy until neutrophil nadir passed and NC at normal range. Leukapheresis: When the ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single apheresis often sufficient. Other circumstances, additional leukaphereses recommended. HIV Infections: See SPC. Severe chronic neutropenia: Congenital neutropenia, 1.2MU daily; Idiopathic or cyclic
B Increased incidence of endometrial cancer, uterine sarcoma. Second primary tumours reported. Contains lactose. C Caution: Coumarin-type anticoagulants, cytotoxic agents. CYP3A4 inducers, CYP2D6 inhibitors. A Hot flushes, thrombolitic/ cerebrovascular events, vaginal bleeding/discharge, pruritus vulvae, endometrial changes, GI distress, dizziness, fluid retention, headache, rash, alopecia, tumour flare, leg cramps.
PARAPLATIN
BMS
2N Alkylating agent. Carboplatin 150mg, 450mg, 500mg. Powder in vials. 150mg-1, A93.90; 450mg1, A281.74; 500mg-1, A31.31. S Advanced ovarian carcinoma of epithelial origin as first line therapy, or second line therapy after other treatments have failed. Small cell carcinoma of the lung. P 400 mg/m2; as single i.v. dose admin. by a (15 to 60 mins) infusion. See SPC for frequency and dosage adjustment. Q No recommendations available (insufficient information). D Severe renal impairment (cc Q 20ml/ min), impaired hearing, severe myelosuppression. Pregancy, lactation. B Monitor renal function. Monitor peripheral blood counts weekly during and after initial course of therapy. Courses should not be repeated more than monthly. Possible combination with anti-emetic. C Aminoglycosides or other nephrotoxic compounds (not recommended), other myelosuppressive compounds (caution). A Nausea and vomiting. Thrombocytopenia, leucopenia and anaemia. Decrease in hearing acuity, paraesthesia, asthenia, alopecia. Abnormalities of renal/liver function tests.
PHARMORUBICIN
Pharmacia
2N Anthracycline. Epirubicin (HCl) 10mg, 50mg. Powder in vials. 10mg-1, A23.82; 50mg-1, A118.97.
2
ALSO PHARMORUBICIN SOLUTION Epirubicin (HCl) 2mg/ml. Red aq. soln. in vials for IV inf. 10mg-1, A30.50. 50mg-1, A130.88. S Carcinoma of the breast and ovary, superficial bladder carcinoma, non-Hodgkin’s lymphoma. V Conventional doses: 60-120mg/m2 body surface area inj. IV over 3-30mins. Repeat dose at 21 days intervals. Small cell lung cancer: 120mg/m2 day 1 every 3 weeks. Non-small cell lung cancer: 135mg/m2 day 1 or 45mg/m2 days 1, 2, 3 every 3-4 weeks. Papillary transitional cell carcinoma of bladder: 50mg/50ml intravesical inj. weekly for 8 weeks. See SPC. D Non-malignant disease, cardiac NOLVADEX-D AstraZeneca disorders, elderly (only if essential). Severe hepatic 5MO impairment, acute infections, persistent bone Anti-oestrogen. Tamoxifen (citrate) 20mg. White marrow depression. Patients already on max. doses octagonal film-ctd tab. marked NOLVADEX-D. 30, of other anthracyclines or anthracenediones. A4.33. Haematuria, UTIs, inflammation of bladder. S Breast cancer. Pregnancy, lactation (only if essential). P 20-40mg daily; as single dose or divided B Special attention at high doses. Monitor in 2. haematological function freq. Assess cardiac Q Not recommended. function before therapy. Check liver function tests D Pregnancy, lactation. regularly. Local pain and swelling may occur at inj.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
333
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
P 11.25mg as single SC inj. at 3 month intervals. Q Not applicable. D Patients insensitive to endocrine therapy/post orchidectomy. B Diabetics (monitor blood glucose). To reduce risk of flare on initial therapy, an antiandrogen may be admin. 3 days before therapy and continued for 2-3 weeks. Risk of ureteric obstruction or spinal cord compression; monitor PROLEUKIN Novartis 1st few weeks, consider anti-androgens. Hepatic dysfunction and jaundice reported; close 2NT observation. Spinal fracture, paralysis, hypotension Immunostimulant. Aldesleukin 18x106 IU/ml. Powder for soln for inj., powder for soln for inf. in and worsening of depression have been reported. Driving/ using machines. vial. 1ml, A217.09. A Oedema, hypertension, palpitations, S Treatment of metastatic renal cell fatigue, muscle weakness, GI upsets, headache, carcinoma. P SC inj: 18x106 IU SC every day for 5 days, bone/muscle pain, dizziness, insomnia, liver function test increases, inj. site reactions, changes followed by 2 days rest. For following 3 weeks, in blood lipids/glucose. Tumour flare, hot flushes, 18x106 IU SC on days 1 and 2 of each week loss of libido. followed by 9x106 IU on days 3-5. Rest on days 6 and 7. After 1 week rest, repeat 4-week cycle. IV PROVERA Pharmacia continuous inf: 18X106 IU per m2 per 24-hrs for 5 days, followed by 2-6 days without active 2NO substance, an additional 5 days of continuous inf. Progestogen. Medroxyprogesterone acetate and 3 weeks without active substance. Then give 100mg. White scored tab. marked U467. 100mgsecond induction cycle. Up to 4 maintenance cycles 100, A47.69. (18x106 IU per m2 as continuous inf. for 5 days) S Certain hormone dependent neoplasms may be given with 4-week intervals. (e.g. breast carcinoma) in post-menopausal D ECOG r2. ECOG r1 and r2 metastatic women, endometrial and renal cell carcinoma. sites and time from diagnosis of primary tumour P Breast carcinoma, 400-800mg daily; max. to Proleukin therapy Q24 months. History of 1000mg daily. Endometrial and renal cell severe cardiac disease, infection requiring carcinoma, 200-400mg daily. antibiotics, Pa O2Q60mmHg during rest, major organ dysfunction, CNS metastases (unless treated Q Not applicable. D History of thromboembolic disorders, successfully) or seizure disorders. Others not liver dysfunction, pregnancy. recommended; See SPC. Pregnancy, lactation. B History of depression, diabetes, epilepsy, B Renal/hepatic dysfunction; monitor migraine, asthma, cardiac or renal dysfunction. closely. Diabetes, elderly. May exacerbate C Aminogluthetimide. autoimmune disease, effusions from serosal A Galactorrhoea, corticoid symptoms, surfaces (treat first). Severe lethargy or thromboembolic disorders, insomnia, fatigue, rash, somnolence (discontinue if occur), capillary leak weight gain. syndrome. Monitor for haematologic effects, blood chemistry, chest x-rays before and during PURI-NETHOL GSK treatment. Driving/using machines. 2NO C Caution: Drugs with hepatotoxic, nephrotoxic, myelotoxic, or cardiotoxic effects, Nucleoside analogue. Mercaptopurine 50mg. Fawn CNS acting drugs, antihypertensives, antineoplastic scored tab. coded GX above score and EX2 below agents, cis-platinum, vinblastine, dacarbazine, score. 25, A17.88. interferon-alfa. S Acute leukaemia. Maintenance therapy A Fever, headache, pain, weight change, in: Acute lymphoblastic leukaemia, acute GI disorders, dyspnoea, cough, hypotension, chest myelogenous leukaemia, chronic granulocytic pain incl. angina pectoris, hypertension, leukaemia. tachycardia, dizziness. Mental status changes eg. R Reduce dose in renal and hepatic irritability, confusion, depression. Inj. site reaction, impairment. See SPC. skin exfoliation, pruritus. Arthralgia, oedema, V Usual dose: 2.5mg/kg/day or 50-75mg/m2 dehydration, myalgia, hypothermia. Elevated body surface area per day depending on dose of hepatic enzymes and serum urea/creatinine, other cytotoxic drugs given with puri-nethol. A oliguria, anaemia, thrombocytopenia, leukopenia, quarter of the usual dose given if co-admin. with hyperglycaemia. allopurinol. D Acute untreated infections. Pregnancy, PROSTAP SR Takeda lactation. 6NT B Mylosuppressant: Monitor during and LHRH analogue. Leuprorelin acetate 3.75mg. after therapy. Full blood counts must be taken Powder and 1ml solvent for prolonged-release during remission induction. Monitor liver function suspension for inj. 1, A163.01. weekly. Dose reduction in renal transplant S Management of prostatic carcinoma patients. Monitor uric acid levels. Mutagenicity when testosterone suppression is indicated. and carcinogenicity reported rarely. P 3.75mg admin. by SC or IM inj. once C Not recommended: Live organism monthly. vaccinations. Allopurinol, warfarin. Caution: 6NT Aminosalicylates. A Bone marrow suppression, leucopenia, ALSO PROSTAP 3 Leuprorelin (acetate) 11.25mg. Powder as microsphere depot in vial plus 2ml thrombocytopenia. GI disturbances, pancreatitis, diluent. 1, A489.03. biliary stasis, hepatotoxicity. site. Pregnant staff: Avoid working with this drug. C Other cardiotoxic drugs. CYP450 inducers/inhibitors, cimetidine. A Bone marrow suppression, GI disturbances, stomatitis, allergic reactions, weakness, alopecia. Thrombophlebitis, urine discolouration, infection, anorexia, conjunctivitis, hot flushes, skin changes, amenorrhoea, fever, photosensitivity.
334
RATIOGRASTIM
ratiopharm
5NT Recombinant human granulocyte colony stimulating factor (G-CSF) Filgrastim 60MIU/ml. Clear, colourless sln for inj. or inf. in pre-filled syringes. 30 MIU/0.5ml-5, A448.37; 48MIU/0.8 ml-5, A 714.96. S Reduction in duration of neutropenia and incidence of febrile neutropenia after established cytotoxic chemotherapy; reduction in duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. Long term treatment to increase neutrophil counts (NC) and reduce incidence and duration of infection-related events in patients with severe congenital, cyclic or idiopathic neutropenia and history of severe or recurrent infections. Mobilisation of peripheral blood progenitor cells (PBPC). HIV associated neutropenia. V Established cytotoxic chemotherapy: 0.5MIU/kg/day as a daily SC injection or IV infusion less than 24 hours following therapy. Bone marrow transplantation: Initially 1MIU/kg/day as 30 min or 24 hr IV inf. or by continuous SC inf. within 24 hrs. Titrate against neutrophil response (see SPC). Mobilisation of PBPCs: Alone, 1MIU/kg/ day as 24 hour SC continuous inf. or a single daily SC inj. for 5-7 consecutive days. Leukapheresis: 1 or 2 on days 5 and 6. PBC mobilisation after myelosuppressive chemotherapy: 0.5MIU/kg/day by SC inj. from 1st day after chemotherapy completion until neutrophil nadir passed and ANC in normal range; leukapheresis: When ANC rises from Q0.5 x 109/L to q5 x 109/L. Patients who have not had extensive chemotherapy, single leukapheresis often sufficient. Severe chronic neutropenia: Congenital neutropenia, 1.2MIU/kg/ day SC as single dose or in divided doses. Idiopathic or cyclic neutropenia, 0.5MIU/kg/day SC; as single dose or in divided doses. Continue until ANC at q1.5 x109/L, establish minimum required to maintain this level. After 1-2 weeks double or half depending on response; adjust every 1-2 weeks thereafter to maintain average ANC between 1.5 x 109/L - 10 x 109/L. Severe infections, consider faster dose escalation; long-term safety of doses q 2.4MIU/kg/day not established. HIV Infections: Reversal of neutropenia, initially 0.1MIU/kg/day by SC inj. with titration up to max 0.4MIU/kg/day until a normal ANC reached and maintained (ANC q 2.0 x 109/L). Doses up to 1MIU/kg/day may be needed in some patients. Maintaining normal ANC: Establish minimal effective dose; initial dose adjustment to alternate day dosing with 30MIU/day by SC injection. Further dose adjustment may be necessary depending on patientâ&#x20AC;&#x2122;s ANC. Long term admin. may be required. B Myelodysplastic syndrome, chronic myelogenous leukaemia: Safety not established. Caution: Secondary AML, underlying osteoporotic bone diseases (treatment q 6 months, monitor bone density), recent history of pulmonary infiltrates or pneumonia, high dose chemotherapy. Perform white blood cell count regularly. Regular monitoring of platelet count and haematocrit recommended. Increased haematopoietic activity of the bone marrow has been associated with transient positive bone-imaging findings. Pregnancy (only if benefit outweighs risk), lactation. Contains sorbitol. See SPC. C Not recommended within 24 hours of chemotherapy. A Musculoskeletal pain. Cancer patients:
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
DISORDERS
Q Under 18 years, not recommended. D Pregnancy, lactation. Women of childbearing potential unless all conditions of Pregancy Prevention Programme are met. Perform pregnancy tests prior to treatment, every 4 weeks including 4 weeks after the end of treatment. Male patients should use condoms throughout and up to one week after treatment. B Specialist supervision required. Monitor renal function. Hypothyroidism reported. Neurotoxic potential. Contains lactose. Driving/ operating machines. C Avoid combined oral contraception pills. RETACRIT Hospira Caution: Warfarin, digoxin. A Neutropenia, thrombocytopenia, 5NT anaemia. GI disorders, cerebrovascular accident, Erythropoietin. Epoetin zeta. Clear, colourless sln syncope, neuropathy, dizziness, ageusia, para/ for inj. in pre-filled syringe. 1000 IU/0.3ml-6, A54.59; 2000 IU/0.6ml-6, A104.82; 3000 IU/0.9ml-6, hypoaesthesia, headache, tremor, memory impairment, vision disorders, vertigo, RTIs, A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5mldyspnoea, hiccups, renal failure, rash, muscle 6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ cramp/weakness, cushingold-like symptoms, 0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; thrombosis, hypotension, hypertension, flushing, 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, fatigue, oedema, reproductive syst. disorders, A273.01; 40000 IU/1ml-1, A363.97. iInsomnia, confusional state, mood alteration. S Anaemia and reduction of transfusion Hyperglycaemia, fluid/mineral balance alteration. requirements in adult patients receiving See SPC for other common reactions. chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of ROFERON-A Roche transfusion as assessed by patient’s general status. P Initially 150 IU/kg subcutaneously thrice 2 N T Single-subtype recombinant. Interferon alfa-2a weekly, alternatively 450 IU/kg once weekly. (rbe) 3, 4.5, 6 and 9 mega units. Pre-filled syringes, Continue until 1 month after end of cartridge for Roferon-Pen. 3 mega units-1 x 0.5ml, chemotherapy (dose adjustment, see SPC ). A22.83; 4.5 mega units-1 x 0.5ml, A34.23; 6 mega D Patients with Pure Red Cell Aplasia units-1 x 0.5ml, A45.65; 9 mega units- 1 xo.5ml, (PRCA) following treatment with erythropoietin. A68.48. Uncontrolled hypertension. Patients unable to S Single agent treatment of metastatic receive adequate antithrombotic prophylaxis. B Correct other causes of anaemia; ensure malignant melanoma, hairy cell leukaemia, recurrent or metastatic renal cell carcinaoma. adequate iron stores. Monitor BP, platelet count, AIDS-related Kaposi’s sarcoma (with no history of reticulocyte count, Hb. Chronic renal failure: opportunistic infection) and adult chronic active Monitor serum electrolytes; hyperkalaemia may hepatitis B. Chronic phase Philadelphiaoccur (discontinue until corrected). Caution: chromosome positive chronic myelogenous Epilepsy, chronic liver failure. PRCA may occur leukaemia, progressive cutaneous T-cell lymphoma, (discontinue immediately, see SPC). Increased risk refractory to, or unsuitable for, conventioanl of thrombotic vascular events in cancer patients. therapy, chronic hepatitis C (non-A non-B). Tumour growth potential cannot be excluded. Follicular non-Hodgkin’s lymphoma. Pregnancy, lactation (only if benefit outweighs P See SPC. risk). Contains phenylalanine. D Severe renal, hepatic or myeloid C Ciclosporin. dysfunction, epilepsy or CNS impairment, cardiac A Headache, dose-dependent increase in disease, decompensated hepatic disease, liver BP, hypertensive crisis with encephalopathy-like cirrhosis. Lactation. symptoms, skin rashes, flu-like symptoms, PRCA, B Should only be used by physicians antibodies to erythropoietins, hypersensitivity experienced in the indications. Patients with reactions, thrombotic/vascular events, shunt suicidal tendencies. Severe myelosuppression thromboses. (monitor blood counts). Moderate renal or hepatic REVLIMID Celgene impairment (monitor function). Pregnancy (ensure effective contraception). 2NT C Immunosuppressants, theophylline. Immunomodulator. Lenalidomide 5mg, 10mg, A Influenza-like symptoms, GI and CNS 15mg, 25mg. White, blue-green/pale yellow, pale effects, alterations of hepatic function. blue/white, white caps. resp. All marked REV and strength. 5mg-21, A5292.00; 10mg-21, A5586.00; SANDOSTATIN Novartis 15mg-21, A5880.00; 25mg-21, A6447.00. S In combination with dexamethasone for 2 N T Somatostatin analogue. Octreotide (acetate) 50, the treatment of multiple myeloma patients who 100, 500mcg/ml. Soln. in amps. 50mcg-5 x 1ml, have received at least one prior therapy. A20.79; 100mcg-5 x 1ml, A39.12; 500mcg-5 x 1ml, P Initially, 25mg once daily on days 1-21 A189.51. of repeated 28-day cycles, swallowed whole at same time each day. Recommended dose of S Relief of symptoms associated with dexamethasone, 40mg once daily on days 1-4, 9-12 gastroentero-pancreatic (GEP) endocrine tumours and 17-20 of each 28-day cycles for the first 4 incl. carcinoid tumours, VIPomas, glucagonomas, cycles, then 40mg once daily on days 1-4 every 28 gastrinomas (Zollinger-Ellison syndrome), days. See SPC for dose adjustment or restart of insulinomas, GRFomas. treatment according to platelet and absolute P Initial dose: 50mcg once or twice daily neutrophil counts. Renal impairment: See SPC. by SC inj. Depending on response, increase to
Elevated alkaline phosphatase/LDH/uric acid, headache, cough, sore throat, GI disorders, elevated GGT, alopecia, skin rash, chest pain, fatigue, generalised weakness. Mobilisation of PBPCs: Leukocytosis, thrombocytopenia, elevated alkaline phosphatise/LDH, headache. SCN patients: Anaemia, splenomegaly, thrombocytopenia, decreased glucose, elevated alkaline phosphatase/ LDH, hyperuricaemia, headache, epistaxis, diarrhoea, hepatomegaly, alopecia, cutaneous vasculitis, injection site pain, rash, osteoporosis. HIV patients: Spleen disorder.
NEOPLASTIC DISORDERS 20.1 200mcg three times daily. Carcinoid crises: 0.05mg by IV inj. diluted with saline and given as a bolus. Q Not recommended.
2NT ALSO SANDOSTATIN LAR Octreotide (acetate) 10mg, 20mg, 30mg. Microspheres for susp. 4weekly depot inj. 10mg-1, A899.00; 20mg-1, A1198.66; 30mg-1, A1498.33. S For use in patients controlled by subcutaneous Sandostatin. P When control established, initially 20mg by deep intragluteal inj. every 4-weeks for 3 months. Continue with the same dose of Sandostatin SC for 2 weeks after starting Sandostatin LAR. Re-assess after 3 months. Adjust subsequent doses according to the symptoms. Q Not recommended. B Use only under hospital specialist supervision. Pregnancy, lactation. Diabetics may show reduced hypoglycaemic requirements. Long term therapy, monitor thyroid and hepatic function, gall stone development. C Cyclosporin, cimetidine, bromocriptine. A Inj. site reactions, GI upset, gall stones, biliary colic. Rarely persistent hyperglycaemia. Hepatic dysfunction.
SOMATULINE AUTOGEL
Ipsen
2NT Somatostatin analogue. Lanreotide (acetate) 60mg, 90mg, 120mg. Pre-filled syringes. 60mg-1, A900.48; 90mg-1, A1199.54; 120mg-1, A1548.44. S Relief of symptoms associated with carcinoid tumours. P Starting dose, 60-120mg deep SC inj. every 28 days adjusting according to response. Q Not recommended.
2NT ALSO SOMATULINE LA Lanreotide 30mg. Powder in vial plus diluent in amp., needles and syringe. Single unit dose, A531.96. P Initially 30mg by IM inj. every 14 days. Adjust dose frequency according to response (as judged by symptomatology and/or biochemical monitoring). Q Not recommended. D Pregnancy, lactation. B Diabetes (monitor blood glucose). Risk of gallstones (perform echography of gall bladder before therapy, then every 6 months during therapy). C Cyclosporin A. A Pain at inj. site, GI side effects, gallstones, altered glucose regulation.
SPRYCEL
BMS
2NT Tyrosine kinase inhibitor. Dasatinib 20mg, 50mg, 70mg, 100mg. White, biconvex film-ctd tabs. marked BMS (or BMS 100 for 100mg) on one side and 527, 528, 524 or 852 resp. on reverse. 20mg and 70mg, round; 50mg and 100mg, oval. 20mg60; 50mg-60; 70mg-60; 100mg-30. Prices on request. S Chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate. Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. P Chronic Phase CML: 100mg once daily, consistently in the morning or evening, swallowed whole. Accelerated, myeloid or lymphoid blast
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
335
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
phase (advanced phase) CML or Ph+ ALL: Initially 140mg once daily, in the morning or evening, swallowed whole. Duration for both: Until disease progression or no longer tolerated. Dose escalation to 140mg once daily (chronic phase CML) or 180mg twice daily (advanced phase CML or Ph+ ALL) was allowed in patients who did not achieve a haematologic or cytogenetic response. Dose adjustment for undesirable effects, see SPC. Q Not recommended. D Pregnancy (use contraception), lactation. B Moderate to severe hepatic impairment. Risk of anaemia, neutropenia and thrombocytopenia; complete blood counts should be performed weekly for the first 2 months, and then monthly thereafter, or as clinically indicated. May occur: Severe CNS and GI haemorrhage, severe fluid retention including pleural and pericardial effusions (evaluate by chest x-ray). Caution: Congenital or history of QT prolongation, hypokalaemia or hypomagnesemia (correct before initiating therapy). Contains lactose. Driving/using machinery. C Not recommended: Potent CYP3A4 inhibitors and inducers. Caution: Substrates of CYP3A4 (especially those with narrow therapeutic index), H2 antagonists, PPIs and antacids. CYP2C8 substrates (e.g. glitazones) A Most frequently reported: Infection (incl. bacterial, viral, fungal, non-specific), headache, haemorrhage, pleural effusion, dyspnoea, cough, GI disorders, skin rash, musculoskeletal pain, fluid retention, fatigue, superficial oedema, pyrexia. See SPC.
P 50mg once daily for 4 weeks followed by 2 week rest period to complete 6 week cycle. Titrate individually in increments of 12.5mg. Max. 87.5mg daily; min. 37.5mg daily. If a dose is missed the patient should not be given an additional dose. Q Not recommended. D Pregnancy, lactation. B Tumour haemorrhage, serious GI complications, reported rarely. Perform complete blood counts at beginning of treatment. Monitor for CHF. History of QT interval prolongation, cardiac disease, bradycardia, or electrolyte disturbances. Pancreatitis, proteinuria, nephrotic symptom reported rarely; seizures; angioedema, fistula (interrupt if occurs). C Avoid CYP3A4 inhibitors; if not possible, reduce dose to min. 37.5mg daily. Avoid CYP3A4 inducers; if not possible, increase dose in 12.5mg increments (up to 87.5mg/day). A Blood/lymphatic disorders, venous thromboembolic / pulmonary events, hypothyroidism, lacrimation increased, anorexia, dehydration , decreased appetite, dysgeusia, headache, dizziness, paraesthesia, hypertension, epistaxis, chromaturia, GI disorders, skin and SC tissue disorders, pain in extremity, arthralgia, myalgia, fatigue, mucosal inflammation, oedema, blister. Hb, platelet count, weight, WBC; decreased. Blood creatinine phosphokinase, lipase, blood amylase increased.
substrates, coumarin anticoagulants, Pgp inhibitors, e.g. cyclosporine, verapamil. A Rash, diarrhoea. Infection, anorexia, keratitis, dyspnoea, cough, GI disorders, GI bleeding, fatigue. Liver function test abnormalities.
TARGRETIN
Cephalon
2NT
Synthetic retinoid. Bexarotene 75mg. Soft offwhite cap. containing liquid susp. imprinted â&#x20AC;&#x2122;Targretinâ&#x20AC;&#x2122;. 100, A1676.75. S Treatment of skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) patients refractory to at least one systemic treatment. P Initially, 300mg/m2/day as single oral dose with food; may be adjusted to 200mg/m2/day then 100mg/m2/day or temporarily suspend if necessitated by toxicity. For initial dose calculations: See SPC. R As for adult (monitor) Q Under 18 years, not recommended. D Pregnancy, lactation, women of childbearing age (without adequate contraception), pancreatitis (history), uncontrolled hypercholesterolaemia, hypertriglycerideamia, thyroid disease; hypervitaminosis A, hepatic insufficiency, ongoing systemic infection. B Retinoid hypersensitivity, hyperlipidaemia, pancreatitis (risk factors), liver enzyme elevation, thyroid function test alteration, TAMOX Rowex leucopenia/anaemia, diabetes mellitus (patients 5MO using insulin), photosensitivity, lens opacities. Anti-oestrogen. Tamoxifen (citrate) 10mg, 20mg. Avoid donating blood. SUPREFACT DEPOT sanofi-aventis White film-ctd tabs. 10mg-30, A6.08; 20mg-30, C CYP3A4 substrates, CYP3A4 inducers. 6NT A7.21. Gemfibrozil, grapefruit juice, CA125 assay value GnRH analogue. Buserelin (acetate) 6.6mg. S Palliative management of breast cancer. alteration. Implant (2 controlled release rods). 1, A295.77. P 20-40mg once daily. A Hyperlipaemia, hyperthyroidism, S Long-term treatment of prostate Q Not applicable. hypercholesterolaemia, headache, leucopenia, carcinoma with dose interval of 2 months. D Pregnancy. asthenia, pruritus, rash, exfoliative dermatitis, P See SPC. B Lactation. Contains lactose. pain/myalgia, insomnia, dizziness, GI disturbances, Q Not applicable. C Coumarin-type anticoagulants, cytotoxic eye/ear disorders, oedema. 6N agents (increased risk of thromboembolic events). ALSO SUPREFACT INJECTION Buserelin (acetate) Novartis A Hot flushes, vaginal bleeding/discharge, TASIGNA 1mg/ml. Vial. 2 x 5.5ml, A41.43. pruritus vulvae, GI intolerance, dizziness, tumour 2NT 6NT flare, visual disturbances, skin rash, pulmonary Tyrosine kinase inhibitor. Nilotinib 200mg (as ALSO SUPREFACT NASAL SPRAY Buserelin embolism. hydrochloride monohydrate). White to slightly (acetate) 100mcg/dose. 4 x 100 dose unit, A136.33. yellowish powder in light yellow opaque hard TARCEVA Roche S Stage C or D prostatic carcinoma in gelatine caps, size 0 with red axial imprint NVR/ which suppression of testosterone is indicated. 2NT TKI. 112, Price on request. P Initially: 0.5ml by SC inj. every 8 hrs for Tyrosine kinase inhibitor. Erlotinib (as erlotinib S Treatment of adults with chronic phase 7 days. Maintenance: 1 application in each nostril HCl) 25mg, 100mg, 150mg. White, round, biconvex and accelerated phase Philadelphia chromosome 6 times daily. tabs. marked with Tarceva followed by strength positive chronic myelogenous leukaemia (CML) Q Not applicable. and logo. Price available on request. with resistance or intolerance to prior therapy D Hormone insensitive tumours. After S Locally advanced or metastatic nonincluding imatinib. orchidectomy. small cell lung cancer after failure of at least one P 400mg twice daily approx 12 hrs apart. B Disease flare may occur and can be prior chemotherapy regimen. Not to be taken with food (no food for 2 hrs prevented by prophylactic use of antiandrogens. P 150mg daily taken at least one hour before admin and for at least 1 hr after). Continue A Hot flushes, loss of libido. Transient before or two hours after food. When dose treatment as long as patient continues to benefit. nasal irritation. adjustment necessary, reduce in 50mg steps. May need to withhold temporarily and/or reduce Q Under 18 years, not recommended. dose (neutropenia, thrombocytopenia, see SPC). SUTENT Pfizer D Severe hepatic or severe renal Q Under 18 years, not recommended. 2NT impairment. Pregnancy (use adequate D Pregnancy (unless clearly necessary), Tyrosine kinase inhibitor. Sunitinib (as malate) contraception for at least 2 weeks after lactation. 12.5mg, 25mg, 50mg. Gelatin caps marked Pfizer completing therapy), lactation. B Associated with thrombocytopenia, on cap and STN and strength on body. 12.5mg, B Hepatic impairment (caution). Interstitial neutropenia and anaemia (especially acceleratedorange; 25mg, caramel cap and orange body; lung disease (discontinue if occurs). Severe or phase CML); complete blood counts every 2 weeks 50mg, caramel. PTW: 12.5mg-28, A1222.06; 25mg- persistent diarrhoea/vomiting (interrupt therapy for first 2 months; then monthly or as indicated. A A 28, 2444.12; 50mg-28, 4888.24. and treat dehydration). Contains lactose. Use with caution in patients with or at significant S Unresectable and/or metastatic C Avoid potent inhibitors/inducers of risk of developing prolongation of QTc. Correct malignant GI stromal tumour (GIST) after failure CYP3A4. Stop smoking. Caution: Antacids, PPIs, H2 hypokalaemia or hypomagnesaemia prior to of imatinib mesylate treatment. Advanced and/or antagonists, CYP3A4, CYP1A2, CYP1A1 and treatment. Caution: Hepatic impairment, history of metastatic renal cell carcinoma (MRCC). CYP1B1 substrates and modulators, UGT1A1 pancreatitis, relevant cardiac disorders. Contains
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
lactose. C Avoid: Strong CYP3A4 inhibitors, grapefruit juice and other foods known to inhibit CYP3A4. Not recommended: CYP3A4 inducers, substances suppressing gastric acid secretion. Caution: Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2D6, UGT1A1 with a narrow therapeutic index, warfarin, midazolam, anti-arrhythmic medicinal products or other medicinal products that may lead to QT prolongation. A Headache, GI disorders, rash, pruritus, alopecia, eczema, urticaria, erythema, hyperhidrosis, dry skin, myalgia, arthralgia, muscle spasms, bone pain, anorexia, fatigue, asthenia, oedema peripheral. Increased lipase, blood amylase, ALT, AST, bilirubin, alkaline phosphatase, gamma-glutamyltransferase, creatinine phosphokinase, blood glucose. Weight decreased or increased, palpitations, prolonged electrocardiogram QT, febrile neutropenia, pancytopenia, dizziness, paraesthesia, vertigo, dyspnoea, dyspnoea exertional, cough, dysphonia, night sweats, musculoskeletal chest pain, musculoskeletal pain, hypomagnesaemia, hyperkalaemia, hyperglycaemia, hypertension, flushing, pyrexia, insomnia.
2NT
Alkylating agent. Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg, 250mg. White/coloured caps. marked in black ink with Temodal on cap and strength, the Schering-Plough logo and two stripes on the body. 5mg-5, A25.76; 20mg-5, A103.05; 100mg-5, A515.26; 140 mg-5, A778.85; 180mg-5, A1001.23; 250mg-5, A1288.17. S Newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy. Malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. P Swallow caps. whole with water in fasting state. Concomitant phase: 75mg/m2 daily for 42 days with focal RT, see SPC. Monotherapy phase: Start 4 weeks after completing concomitant phase and admin. for up to 6 cycles. Cycle 1: 150mg/m2 once daily for 5 days + 23 days without treatment. Cycle 2, increase to 200mg/m2 according to toxicity, see SPC. Once escalated, dose remains at 200mg/m2 per day for 1st 5 days of each subsequent cycle except if toxicity occurs. If dose not increased at Cycle 2, do not increase in subsequent cycles. Dose reductions and discontinuations during the monotherapy phase, TAXOTERE sanofi-aventis see SPC. Recurrent or progressive malignant glioma: Treatment cycle: 28 days. Patients 2JN previously untreated with chemotherapy, 200mg/ Taxane. Docetaxel 20mg, 80mg. Concentrate and solvent for soln, for inf. Price available on request. m2 once daily for 5 days + 23 day treatment interruption. Patients previously treated with S Locally advanced or metastatic breast chemotherapy, initially 150mg/m2 once daily, cancer in combination with doxorubicin for increased in the second cycle to 200mg/m2 once patients who have not previously received daily, for 5 days if there is no haematological cytotoxic therapy for this condition. Locally advanced or metastatic breast cancer after failure toxicity. of cytotoxic therapy, which should have contained Q Recurrent or progressive malignant glioma: Patients 3 years of age or older, as per an anthracycline or alkylating agent. Locally adults. advanced or metastatic breast cancer in D Hypersensitivity to dacarbazine. Severe combination with capecitabine after failure of anthracycline-containing cytotoxic therapy. Locally myelosuppression. Pregnancy, lactation. advanced or metastatic non-small cell lung cancer B Monitor for Pneumocystis carinii pneumonia (PCP); concomitant regimen: (NSCLC) in combination with cisplatin in patients Prophylaxis against PCP required. Anti-emetic who have not previously received chemotherapy therapy may be required, see SPC. Prior to dosing for this condition. Locally advanced or metastatic the following must be met: ANCr1.5x109/l and NSCLC after failure of prior chemotherapy. platelet count r100x109/l. A complete blood Hormone refractory metastatic prostate cancer in count should be obtained on Day 22 and weekly combination with prednisone or prednisolone. P Admin as a 1-hour IV inf. every 3 weeks. until ANC q1.5x109/l and platelet count q100x109/ l. If ANC falls Q1.0x109/l or platelet count is Breast cancer monotherapy: 100mg/m2. Breast Q50x109/l during any cycle, the next cycle should cancer in combination, NSCLC mono or be reduced one dose level. Caution: Elderly. Men combination, or prostate cancer in combination: should not father a child during and up to 6 75mg/m2. months after treatment. Contains lactose. Q Not recommended. C Valproic acid. D Previous severe hypersensitivity to A Both: Infection, oral candidiasis, docetaxel or excipients. Baseline neutrophils thrombocytopenia, leukopenia, anorexia, weight Q1500 cells/mm3 . Severe liver impairment. decreased, anxiety, emotional lability, insomnia, Pregnancy, lactation. nervous system disorders, hearing impaired, eye B Pretreat with oral corticosteroid to disorders, haemorrhage, dyspnoea, coughing, GI reduce incidence of fluid retention (see SPC). disorders, skin and SC tissue disorders, muscle Monitor blood counts. Monitor patients during weakness, arthralgia, urinary incontinence, inf. for hypersensitivity reactions. Patients with fatigue, oedema leg, allergic reaction, fever, liver impairment require liver function tests. radiation injury, pain, taste perversion, ALT Contraception required during and for 3 months increased. TMZ + concomitant RT only: Herpes after therapy. simplex, wound infection, pharyngitis, C Caution: Cyclosporin, ketoconazole, neutropenia, lyphopenia, hyperglycaemia, erythromycin, troleandomycin, terfenadine. oedema, erythema, micturition frequency, face A Neutropenia, febrile neutropenia, oedema. TMZ monotherapy only: Febril thrombocytopenia, anaemia, hypersensitivity neutropenia, anaemia, depression, tinnitus, DVT, reactions, cutaneous reactions, fluid retention, nausea, vomiting, diarrhoea, stomatitis, peripheral musculoskeletal pain, myalgia. neuropathy, increase in liver enzymes, alopecia, THALIDOMIDE PHARMION Celgene myalgia, mucositis.
TEMODAL
2T Schering-Plough Immunosuppressive agent. Thalidomide 50mg.
White opaque hard cap. marked Thalidomide 50mg Pharmion. 28, A336. S In combination with melphalan and prednisone as 1st-line treatment of patients with untreated multiple myeloma, aged r 65 years or ineligible for high dose chemotherapy. Prescribe and dispense according to the Thalidomide Pharmion Pregnancy Prevention Programme (see SPC). P 200mg/day in single dose at bedtime. Max duration: 12 cycles of 6 weeks. Antithrombotic prophylaxis recommended for patients at risk of thromboembolic events. Peripheral neuropathy: See SPC for dose adjustment. Q Not recommended. D Pregnant women, women of childbearing potential unless all conditions of the Thalidomide Pharmion Pregnancy Prevention Programme are met, patients unable to follow or comply with required contraceptive measures. Lactation. B Powerful teratogen, all patients must fulfil the conditions of the Thalidomide Pharmion Pregancy Prevention Programme, see SPC. Increased risk of DVT and pulmonary embolus. Monitor for symptoms of peripheral neuropathy, syncope and bradycardia. Discontinue if toxic skin reactions (e.g. Stevens-Johnson syndrome) occur. Caution: Renal or hepatic impairment. Driving/ operating machines. Contains lactose. C Not recommended: Combined hormonal contraceptives. Caution: Anxiolytics, hypnotics, antipsychotics, H1 anti-histamines, opiate derivatives, barbiturates, alcohol, drugs inducing torsade de pointes, beta blockers, anticholinesterase agents, vincristine, bortezomib, warfarin (with prednisone). A Cardiac failure, bradycardia, neutropenia, leukopenia, anaemia, lymphopenia, thrombocytopenia, peripheral neuropathy, tremor, dizziness, paraesthesia, dysaesthesia, somnolence, abnormal coordination, pulmonary embolism, interstitial lung disease, bronchopneumopathy, dyspnea, GI disturbances, toxic skin eruption, rash, dry skin, pneumonia, deep vein thrombosis, peripheral oedema, pyrexia, asthenia, malaise, confusional state, depression.
TOMUDEX
AstraZeneca
2NO Folate analogue. Raltitrexed 2mg. Powder in vial. 1 x 5ml. Price available on request S Treatment of advanced colorectal cancer P 3mg/m2 as a 15 min. IV inf. Repeat if necessary at 3 week intervals. See SPC. Q Not recommended. D Severe renal impairment. Pregnancy, lactation. B Monitor patients for toxic effects during treatment. Depressed bone marrow function, prior to radiotherapy. Elderly. Conception should be avoided during and for at least 6 months after cessation. Ability to drive or operate machinery may be impaired. C Folinic acid, folic acid, vitamins. A Nausea, vomiting, diarrhoea, anorexia, leucopenia, anaemia, thrombocytopenia, athralgia, hypertonia, rash, pruritus, asthenia, fever.
TORISEL
Wyeth
2J mTOR inhibitor. Temsirolimus 25mg/ml (10mg/ml when diluted). Clear, colourless to light-yellow
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
337
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS pleuritic pain, dyspnoea, bone pain, arthralgia, pyrexia, fatigue, ECG QT prolonged, ALT/AST increased.
non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecancontaining chemotherapy regimens. P 6 mg/kg BW, given once every 2 weeks. TYVERB GSK Prior to infusion, should be diluted in 0.9% NaCl injection to a final concentration of 10 mg/ml 2T max. Dilute doses q1000mg in 150ml 0.9% NaCl. Tyrosine kinase inhibitor. Lapatinib 250mg (as lapatinib ditosylate monohydrate). Oval, biconvex, Must be given as an IV infusion via an infusion pump. See SPC. yellow film-ctd tabs, with GS XJG debossed on 1 Q Under 18 yrs, not recommended. side. 70, price on request. D Interstitial pneumonitis or pulmonary S In combination with capecitabine for fibrosis. Pregnancy (use contraception during treatment of advanced or metastatic breast cancer treatment and for 6 months after last dose), in patients with tumours overexpressing ErbB2 lactation (during treatment and for 3 months after (HER2). Patients should have progressive disease last dose). following prior therapy which must include B Mild to moderate dermatological anthracyclines and taxanes and therapy with reactions occur in nearly all patients. If r grade 3 trastuzumab in the metastatic setting. (NCI-CTC/CTCAE) dermatological reactions occur, P 1250mg once daily continuously either temporarily withhold until improvement (R grade at least 1 hr before or at least 1 hr after food. 2). Reinstate administration at 50% original dose; Daily dose should not be divided. Capecitabine if reactions do not recur, escalate dose by 25% recommended dose: 2000 mg/m2/day taken in 2 increments. Discontinue permanently if reactions doses 12 hrs apart on days 1-14 in a 21 day cycle recur. Monitor patients if infectious complications with food or within 30 minutes after food. of dermatological reactions occur. Sunlight can R q 65 years, limited data. exacerbate skin reactions, limit sun exposure and Q Not recommended for use in use adequate solar protection. Pulmonary paediatrics. symptoms require treatment interruption and D Pregnancy (unless clearly necessary), prompt investigation; discontinue if pneumonitis lactation. or lung infiltrates diagnosed. Monitor patients for B Decreases in left ventricular ejection fraction (LVEF) may occur; caution with conditions hypomagnesaemia every 2 weeks during and 8 weeks after treatment. Contains that could impair LV function. Evaluate LVEF in all treatment + patients prior to treatment initiation. Discontinue Na . C Not recommended: IFL, bevacizumab in patients with symptoms associated with decreased LVEF that are rgrade 3 NCI CTCAE or if containing chemotherapy regimen. A Rash, erythema, skin exfoliation, LVEF drops below lower limit of normal. Monitor pruritus, dry skin, skin fissures, paronychia, for pulmonary toxicity, discontinue if pulmonary symptoms rgrade 3 NCI CTCAE. Hepatoxicity may diarrhoea, fatigue, inf. reactions (pyrexia, chills), hypomagnesaemia, hypocalcaemia, hypokalaemia, occur; monitor liver function before treatment dehydration, nausea, vomiting, dyspnoea, cough, initiation and monthly thereafter. Caution: headache, conjunctivitis, growth of eyelashes, Moderate / severe hepatic impairment, severe renal impairment. Severe diarrhoea reported; may increased lacrimation, ocular hyperaemia, dry eye, eye pruritus, stomatitis, mucosal inflammation, require oral or IV electrolytes and fluids and onycholysis, hypertrichosis, alopecia, nasal dryness, interruption or discontinuation of treatment. dry mouth, pulmonary embolism. C Avoid: Strong CYP3A4 inhibitors, CYP3A4 inducers, quinidine, verapamil, VELCADE Janssen-Cilag cyclosporine, erythromycin, cisapride, pimozide, 2 repaglinide, substances that increase gastric pH, grapefruit juice. Caution: Moderate CYP3A4 Antineoplastic agent. Bortezomib 3.5mg. White to TRISENOX Cephalon inhibitors. off-white cake or powder for sln for inj. 1 vial, 2J A Decreased LVEF, GI disorders, rash (incl. A1,343.09. S In combination with melphalan and Antineoplastic. Arsenic trioxide 1mg. Conc for soln dermatitis acneiform), anorexia, fatigue, hyperbilirubinaemia, hepatotoxicity, dyspepsia, dry prednisone as 1st line treatment of patient with for inf. 10 amps/pack. Price on request. S Induction of remission and consolidation skin, headache, palmar-plantar untreated multiple myeloma, who are not eligible erythrodysaesthesia, pain in extremity, back pain, in relapsed/refractory acute promyelocytic for high-dose chemotherapy with bone marrow mucosal inflammation, insomnia. leukaemia. transplant. As monotherapy for progressive P Induction: 0.15mg/kg/day by IV until multiple myeloma in patients who have received UROMITEXAN Asta Medica at least 1 prior therapy and who have already bone marrow remission achieved up to day 50. Consolidation: 3-4 weeks after completion of undergone or are unsuitable for bone marrow 2N induction therapy. 0.15mg/kg/day by IV for 25 transplant. Uroprotectant. Mesna 100mg/ml. Soln. in amps. doses given 5 days/week, followed by 2 days P In combination with melphalan and 4ml-15, A32.62; 10ml-15, A73.21. interruption, repeated for 5 weeks. prednisone: 1.3mg/m2 BSA. Nine 6-week treatment 2N D Pregnancy, lactation. cycles. Cycles 1-4 given twice weekly (days 1, 4, 8, ALSO UROMITEXAN TABLETS Mesna 400mg, B APL Differentiation Syndrome may 11, 22, 25, 29, 32). In cycles 5-9 admin. once 600mg. White oblong film-ctd tabs. 400mg-10, occur. ECG Abnormalities incl. QT interval weekly (days 1, 8, 22, 29). As monotherapy: 3A23.13; 600mg-10, A30.05. prolongation may occur (monitor for). Interrupt week treatment cycle: 1.3 mg/m2 BSA twice weekly S Prophylaxis of urothelial toxicity in therapy if toxicity r grade 3 observed. Renal for 2 weeks (days 1, 4, 8, and 11) followed by a patients treated with ifosfamide or failure, elderly. Monitor electrolyte and glycaemia 10-day rest period (days 12-21). Minimum 72 hrs cyclophosphamide. See lit. levels, haematologic, hepatic, renal and between consecutive doses. Patients with coagulation parameter tests at least twice weekly. confirmed complete response: 2 additional cycles VECTIBIX Amgen Hyperleukocytosism may develop. of treatment beyond confirmation. Responding 2 J M C Caution: Other medicines that prolong patients not achieving complete remission: 8 cycles Monoclonal antibody. Panitumumab 20mg/ml. QT interval or medicines that cause hypokalemia in total. Dose adjustments: See SPC. Solution in vial. 100mg, A424.96; 400mg, A1700. or hypomagnesaemia. Q Not recommended. A Neutropenia, thrombocytopenia, S Monotherapy for the treatment of EGFR D Severe hepatic impairment. Acute hyperglycaemia, hypokalaemia, paraesthesia, diffuse infiltrative pulmonary and pericardial expressing metastatic colorectal carcinoma with
concentrate solution (1.2ml vial) and clear to slightly turbid, light-yellow to yellow diluent solution (1.8ml vial); solution for infusion. Price available on request. S 1st-line treatment of patients with advanced renal cell carcinoma (RCC) with at least 3 of 6 prognostic risk factors. Relapsed and/or refractory mantle cell lymphoma (MCL). P RCC: 25mg IV-infused for 30-60 min once weekly.Give 25 to 50mg IV diphenhydramine (or similar) approx. 30 min before each dose. MCL: 175mg, infused for 30-60 min once weekly for 3 weeks followed by weekly doses of 75mg, infused for 30-60 min. Q Not recommended. D Pregnancy (contraception to be used by males and females), lactation. Moderate and severe hepatic impairment. B Elderly: Increased oedema and pneumonia risk. CNS tumours and/or anticoagulation therapy increases intracerebral bleeding risk. May occur: Renal failure (advanced RCC and/or pre-existing renal insufficiency), cataract (concomitant interferon-a), adverse reactions (reduce dose, see SPC), incl. anaphylactic reaction, hyperglycemia/ diabetes mellitus, immunosuppression, non-specific interstitial pneumonitis, hyperlipaemia, impaired wound healing, angioneurotic oedema-type reactions (concomitant ACE inhibitors). Caution: antihistamine hypersensitivity. Avoid: live vaccines. Contains alcohol. C Avoid: CYP3A4/5 inducers, potent CYP3A4 inhibitors. Caution: moderate CYP3A4 inhibitors. Amphiphilic agents (e.g. amiodarone, statins) may increase amphiphilic pulmonary toxicity. A Bacterial/viral infections, blood creatinine increase, thrombocytopaenia, anaemia, neutropaenia, leukopaenia, lymphopaenia, dysgeusia, dyspnoea, epistaxis, cough, GI disorders, nail/skin disorders, pain, back pain, myalgia, arthralgia, hypokalaemia, hyperglycaemia, hypercholesterolaemia, hyperlipaemia, anorexia, anxiety, insomnia, RTI, UTI, pharyngitis, rhinitis, mucositis, oedema, pyrexia, asthenia, chills. See SPC.
338
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
NEOPLASTIC DISORDERS 20.1
DISORDERS
disease. Pregnancy, lactation. B Extreme caution: Hepatic, renal impairment. Caution: Heart disease, patients at risk of seizures, amyloidosis. May occur: Peripheral neuropathy (monitor for symptoms), haematological toxicities (throughout treatment, monitor complete blood counts incl. platelet counts), GI toxicity, ileus (monitor patients with constipation), orthostatic/postural hypotension, acute diffuse infiltrative pulmonary disease (pretreatment chest radiograph recommended; evalutate benefit/risk ratio if new or worsening symptoms occur), tumour lysis syndrome, potentially immunocomplex-mediated reactions. Males and females should use contraception during therapy and for 3 months after. Driving/ operating machinery. C Potent CYP3A4-inhibitors/inducers (e.g. ketoconazole, ritonavir and rifampicin), antidiabetics. A Infections, herpes zoster (incl. disseminated), thrombocytopenia, neutropenia, anaemia, decreased appetite, peripheral neuropathy, peripheral sensory neuropathy, paraesthesia, headache, dyspnoea (inc. exertional), epistaxis, cough, rhinorrhoea, GI disorders, rash, myalgia, fatigue, pyrexia. See SPC.
VEPESID
Retinoid. Tretinoin 10mg. Soft orange-yellow/redbrown cap. marked ROCHE one side. 100, A313.70. S Induction of remission in acute promyelocytic leukaemia. P Total daily dose 45mg/m2 body surface divided in two equal doses (approx. 8 daily) taken with meals. Continue treatment until complete remission or up to max. 90 days. Q Limited safety and efficacy. 45mg/m2 unless severe toxicity apparent. D Pregnancy, lactation. B Monitor haematologic profile, coagulation profile, liver function tests, serum Ca++, triglyceride and cholesterol levels frequently. Prophylaxis for bleeding and prompt therapy for infection should be maintained. Retinoic acid syndrome is frequently associated with hyperleukocytosis and may be fatal. Risk of thrombosis during 1st month of treatment. C Tetracyclines, low-dose progestogens, vit. A, all-trans retinoid acid and anti-fibrinolytic agents e.g. tranexamic acid, aminocaproic acid, aprotinin. A Retinoic acid syndrome, characterised by fever, dyspnoea, acute respiratory distress, pulmonary infiltrates, pleural effusions, hypotension, oedema, weight gain, hepatic, renal BMS and multiorgan failure. See SPC.
2NT Podophyllotoxin. Etoposide 50mg, 100mg. Pink gelatin caps. 50mg-20, A156.08; 100mg-10, A136.37. S Small cell lung cancer, hodgkin’s disease, lymphosarcoma, acute myeloid leukaemia, resistant non-seminomatous testicular carcinoma. P Admin. alone or with other oncolytic drugs. Usual dose 120-240 mg/m2 daily, on an empty stomach for 5 consecutive days. Bioavailability should be considered (patient to patient variation). Dose adjustments may be required. 21 days interval and satisfactory blood check (i.e. no evidence of myelosuppression) required between courses. If leucocyte count Q 2000/mm3 suspend until blood elements return to acceptable levels.
VIDAZA
Celgene
2N
Nucleoside analogue. Azacitidine 100mg. White lyophilised powder for susp. for inj. 1 vial, A381.00. S Treatment of adult patients not eligible for haematopoietic stem cell transplantation with intermediate-2 and high-risk myelodysplastic syndromes (MDS) according to the International Prognostic Scoring System (IPSS); chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder; acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia according to WHO classification. P Initially 75mg/m2 body surface area by SC inj. daily for 7 days, followed by a rest period 2NT of 21 days (28-day treatment cycle). Minimum of 6 ALSO VEPESID INJECTION Etoposide 20mg/ml. cycles recommended. Continue treatment as long Amp. 10 x 5ml, A199.73. as patient continues to benefit or until disease S Small cell lung cancer. Resistant nonprogression. Premedicate with anti-emetics for seminomatous testicular carcinoma. nausea and vomiting. Dose adjustment due to P Admin alone or with other oncolytic haematological toxicity: See SPC. drugs. 60-120mg/m2, i.v. daily for 5 consecutive days. 21 day interval and satisfactory blood picture R No specific dose adjustments recommended, monitor renal function. (i.e. no evidence of myelosupression) between Q Below 18 years, not recommended. courses. Avoid extravasation. Do not give as intraD Advanced malignant hepatic tumours. cavitary inj. Pregnancy, lactation. D Severe hepatic dysfunction. Pregnancy, B Perform complete blood counts lactation. Women of childbearing years should use regularly, at least prior to each treatment cycle. adequate contraception. Advise patients to promptly report febrile B If radio/chemotherapy prior to episodes. Monitor for signs and symptoms of treatment allow adequate interval for bone bleeding. Renal impairment: Closely monitor for marrow recovery. Monitor: Peripheral blood toxicity. Reported rarely: Renal abnormalities, counts, liver and pulmonary function. Bacterial progressive hepatic coma and death in patients infections should be brought under control before with extensive tumour burden due to metastatic treatment. Caution: respiratory dysfunction, long disease especially in patients with baseline serum term therapy. albumin Q 30g/l. History of severe congestive C Other chemotherapeutic drugs (risk of heart failure, clinically unstable cardiac disease, or tumour lysis syndrome: Monitor patients closely). pulmonary disease: Safety not established. A Myelosuppression (predominantly A Pneumonia, nasopharyngitis, leucopenia, thrombocytopenia), alopecia. neutropenic sepsis, upper respiratory tract infection, urinary tract infection, sinusitis, VESANOID Roche pharyngitis, rhinitis, herpes simplex, febrile 2JN neutropenia, neutropenia, leucopenia,
thrombocytopenia, anaemia, bone marrow failure, pancytopenia, anorexia, hypokalemia, confusional state, anxiety, insomnia, dizziness, headache, intracranial haemorrhage, lethargy, eye haemorrhage, conjunctival haemorrhage, hypertension, hypotension, haematoma, dyspnoea, exertional dyspnoea, pharyngolaryngeal pain, GI disorders, petechiae, pruritus, rash, ecchymosis, purpura, alopecia, erythema, macular rash, arthralgia, myalgia, musculoskeletal pain, haematuria, fatigue, pyrexia, chest pain, injection site erythema/pain/reactions, malaise, decreased weight.
VINBLASTINE
Hospira
2N Vinca alkaloid. Vinblastine (sulphate) 10mg/10ml. Soln. in vial. 10, A132.35. S See lit.
VINCRISTINE
Hospira
2N Vinca alkaloid. Vincristine (sulph.) 2mg/2ml, 5mg/ 5ml. Soln. 5 x 2mg, A126.47; 5 x 5mg, A173.53. S Acute leukaemias, in conjunction with other oncolytic drugs in Hodgkin’s disease, all forms of lymphoma, Wilm’s tumour, sarcomas, tumours of breast, brain and lungs.
XAGRID
Shire
2NT Platelet-reducing agent. Anagrelide 0.5mg. Opaque white hard cap. marked S 063. 100, A503.68. S Reduction of elevated platelet counts in at risk essential thrombocythaemia patients where current therapy is ineffective or inappropriate. P Initially, 1mg/day in two divided doses for at least 1 week. Then may be titrated to achieve platelet count Q600x109/L, ideally 150400x109/L. Do not exceed increment q0.5mg/day in any 1 week. Max. single dose, 2.5mg. Monitor regularly. D Severe hepatic impairment (Child-Pugh classification C). Severe renal impairment (cc Q30ml/min). Pregnancy, lactation. B Hepatic impairment (not recommended if transaminases q5 times the UPL), renal impairment, heart disease. Pretreatment cardiovascular exam recommended. Perform full blood count and liver/renal function tests. Paediatric patients, elderly, driving/using machines. C Caution with: CYP1A2 inhibitors (e.g. fluvoxamine and omeprazole, grapefruit juice), CYP1A2 substrates (theophylline), oral contraceptives, inotropes such as milrinone, enoximone, amrinone, olprinone and cilostazol. A Headache, palpitations, tachycardia, fluid retention, nausea, diarrhoea, anaemia, dizziness, rash, fatigue.
XELODA
Roche
2NT Cytostatic fluoropyrimidine. Capecitabine 150mg, 500mg. Peach tabs with name and strength. 150mg-60, A68.26; 500mg-120, A452.89. S Adjuvant treatment following surgery of stage III (Dukes’ stage C) colon cancer. 1st line monotherapy of metastatic colorectal cancer. 1stline treatment of advanced gastric cancer in combination with platinum-based regiment. In combination with docetaxel for treatment of metastatic breast cancer after failure of cytotoxic therapy which should have included an
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
339
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
anthracycline. Monotherapy for treatment of metastatic breast cancer after failure of taxanes and anthracycline containing chemotherapy regimen. P Gastric: 1000mg/m2 twice daily for 14 days followed by 7-day rest period (1st dose evening of day 1, last dose morning of day 15); or 625mg/m2 twice daily continuously if epirubicin added. Admin. epirubicin (50mg/m2 as a bolus) and platinum-based compound (as 2-hour IV inf.) on day 1 every 3 weeks. Other cancers: 1250mg/m2 twice daily for 14 days, then 7 day rest. Combination - as stated with docetaxel 75mg/m2 as a 1 hour inf. every 3 weeks. Admin. adjuvant treatment (colon cancer) for 6 months. See SPC for dose calculation. Q Under 18 years, not recommended. D Severe hepatic or renal impairment, reactions to fluoropyrimidine, DPD deficiency, blood dyscrasias. Pregnancy, lactation. B History of cardiac disease, hypo-/ hypercalcaemia, nervous system disease, diabetes mellitus, electrolyte disturbance. C Contra: Sorivudine and analogues. Caution: Coumarins, phenytoin, folinic acid, antacids, allopurinol (avoid), interferon-a, radiotherapy. A Hand foot syndrome, pyrexia, fatigue, lower limb oedema, arthralgia, insomnia, depression, herpes zoster, RTI, dehydration, decreased appetite, eye/skin/GI disorders, headache, lethargy, dizziness, blood disorders.
Potent CYP3A4 inhibitors; if not avoidable, closely monitor toxicity, consider dose reduction. Caution: Hepatotoxic medicinal products, inhibitors of P-gp (e.g. cyclosporine, verapamil). Not recommended: Phenytoin. Avoid alcohol. A Increased CPK, creatinine, AST, ALT, AP, gamma-glutamyl transferase. Hyperbilirubinemia, decreased blood albumin, neutropenia (incl. febrile), thrombocytopenia, anaemia, leucopenia, decreased weight, headache, peripheral sensory neuropathy, dysgeusia, dizziness, paraesthesia, dysponea, cough, GI disorders, alopecia, myalgia, arthralgia, back pain, anorexia, dehydration, decreased appetite, hypokalaemia, infection, hypotension, flushing, fatigue, asthenia, pyrexia, oedema (incl. peripheral), inj. site reaction, insomnia.
recommended: Platelet counts Q100,000/mm3 or neutrophil counts Q1500/mm3 , more than 25% of bone marrow infiltrated by lymphoma cells, prior external beam radiation involving more than 25% of active bone marrow, prior bone marrow transplant or stem cell support. Test for HAMA when relevant (see SPC). A Haematological toxicity, infections, secondary myelodysplasia or leukaemia. Asthenia, chills, fever, headache, pain, throat irritation, arthralgia, dizziness, increased cough, dyspnea, pruritus, GI disorders. Others: See SPC.
ZOLADEX
AstraZeneca
6NT
GnRH. Goserelin (as acetate) 3.6mg in a biodegradable depot. Single-dose syringe ZAVEDOS Pharmacia applicator. 1(month course), A159.50. S Prostate cancer suitable for hormone 2NT manipulation. Breast cancer in pre- and periAnthracycline. Idarubicin 5mg, 10mg. Orange-red menopausal women suitable for hormone sterile powder for soln. for inj. in glass vial. 5mg-1, manipulations. A89.62; 10mg-1, A179.25. P One 3.6mg depot SC inj. into anterior S Remission induction of acute nonabdominal wall every 28 days. lymphocytic leukemia (ANLL) in untreated patients Q Not applicable. or in refractory relapsed patients. All as second6NT line treatment. See lit. ALSO ZOLADEX LA Goserelin (acetate) 10.8mg in P Acute non-lymphoblastic leukaemia a biodegradable depot. Single-dose syringe (ANLL): 12mg/m2/day x 3 days with cytosine applicator. 1 (12 week depot), A431.89. arabinoside or 8mg/m2/day x 5 days with/without S Prostate cancer. cytosine arabinoside. Acute lymphoblastic P One 10.8mg depot SC inj. into anterior leukaemia (ALL): 12mg/m2/day x 3 days. abdominal wall every 12 weeks. Q Acute lymphoblastic leukaemia: 10mg/ YONDELIS Pharma Mar m2/day x 3 days. Monitor haematological status Q Not applicable. D Pregnancy, lactation. 2J prior to admin. B Male patients at risk from ureteric Alkylating agent. Trabectedin 0.25mg, 1mg. White 2 T to off-white powder for conc for soln for inf. in ALSO ZAVEDOS CAPS Idarubicin 5mg, 10mg. Red obstruction or spinal cord compression; monitor for 4 weeks. Transient exacerbation of condition cap. and white body marked IDARUBICIN 5 and vial. 0.25mg-1, A530; 1mg-1, A1994. which can be prevented by prophylactic use of IDARUBICIN 10 resp. 5mg-1, A38.03; 10mg-1, S Advanced soft tissue sarcoma, where antiandrogens. anthracyclines and ifosfamide are inappropriate. In A76.08. A Hot flushes, decreased libido, breast combination with pegylated liposomal doxorubicin S Remission induction of AML in elderly swelling and tenderness, rashes. Also in females, untreated patients when IV treatment cannot be (PLD) in relapsed platinum-sensitive ovarian headache, emotioal lability, vaginal dryness, employed. cancer. hypercalcaemia. 2 P 30mg/m orally for 3 days daily as a P 1.5mg/m2 body surface area, admin. as 2 single agent or between 15-30mg/m orally for 3 IV infusion over 24 hrs with a 3-week interval ZOMETA Novartis days in combination with other antileukaemic between cycles. Admin. 20mg dexamethasone IV 2N 30 min prior to treatment. Admin. additional anti- agents. Bisphosphonate. Zoledronic acid 4mg/5ml. emetics as needed. See SPC for dose adjustments. D Profound bone marrow suppression, severe liver or renal impairment, uncontrolled Concentrate for sln for infusion. Price available on Q Not recommended. infection or patients hypersensitive to request. D Concurrent serious or uncontrolled anthracyclins. Pregnancy, lactation. S Prevention of skeletal related events infection. Pregnancy (unless clearly necessary); B Care during prep. and admin. Assess (pathological fractures, spinal compression, contraception for men and women up to 3 haematological profiles before/during therapy. radiation or surgery to bone, or tumour-induced months after treatment). Lactation (up to 3 Monitor cardiac and renal/liver function. May hypercalcaemia) in patients with advanced months after treatment). malignancies involving bone. Treatment of B Criteria required prior to treatment and colour urine red for 1-2 days after admin. A Nausea, vomiting, mucositis, reversible tumour-induced hypercalcaemia (TIH). re-treatment: ANCr1500/mm3, platelet count alopecia, myelosuppression, cardiac toxicity, r100,000/mm3, bilirubin RULN, alkaline P 4mg/5ml reconstituted and diluted with diarrhoea, raised liver function tests. phosphatase (AP)R2.5xULN, albumin r25g/l, ALT 100ml infusion solution and given as a single 15and ASTR2.5xULN, cc r30ml/min, CPKR2.5xULN, min. IV inf. Bayer Schering hbr9g/dl. Weekly monitor bilirubin, AP, ALT, AST ZEVALIN Q Not applicable. 2JN and CPK during cycles 1 and 2 and at least once D Severe renal impairment. Pregnancy, Murine monoclonal antibody. Ibritumomab between treatments in further cycles. Clinically lactation. relevant liver disease: Closely monitor; adjust dose tiuxetan 1.6mg/ml. Kit for radiopharmaceutical B Monitor hypercalcaemia-related preparation for inf. Price available on request. if needed. Neutropenia and thrombocytopenia metabolic parameters and renal function. may occur: Full blood cell count weekly in cycles 1 S Adults with rituximab relapsed or Maintain patients well hydrated prior to and refractory CD20+ follicular B-cell non-Hodgkinâ&#x20AC;&#x2122;s and 2 and once between further cycles. Patients following admin. Avoid over-hydration in patients lymphoma (NHL). developing fever should promptly seek medical at risk of cardiac failure. Caution in patients with P Platelets counts r150,000/mm3: 15MBq severe hepatic insufficiency. attention, start active supportive therapy immediately. Rhabdomyolysis may occur; establish per kg body weight. Platelets counts Q150,000 C Caution when administering with and q100,000/mm3: 11MBq per kg body weight. parenteral hydration, urine alkalinisation and aminoglycosides, nephrotoxic drugs, thalidomide. Max: 1200MBq. See SPC. dialysis as indicated and discontinue. Admin. A Anaemia, headache, nausea, vomiting, Q Under 18 years, not established. through central venous line strongly anorexia, bone pain, myalgia, arthralgia, renal D Pregnancy, lactation. recommended. impairment, fever, flu-like syndrome, B Bone marrow depletion. Not C Contra: Yellow fever vaccine. Avoid: hypophosphataemia.
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2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required