8.6
Therapeutic Index 1.
Alimentary System
1.1 1.2 1.3 1.4 1.5
GORD, ulcers, irritable bowel . . . . . . . . . . . . . . . . . . . . . . 2 Constipation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Diarrhoea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Ano-rectal conditions, colitis . . . . . . . . . . . . . . . . . . . . . 16 Gallstones, pancreatic disorders . . . . . . . . . . . . . . . . . . . 19
2.
Circulatory System
2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9
Congestive heart failure, tachycardia, post-MI . . . . . . . Angina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Oedema . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hypertension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peripheral vascular disorders . . . . . . . . . . . . . . . . . . . . . Prophylaxis of MI, stroke and vascular death. . . . . . . . Haemorrhage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Hypercholesterolaemia - lipidaemic . . . . . . . . . . . . . . . . Erythropoiesis, granulocytopenia . . . . . . . . . . . . . . . . . .
3.
CNS
3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8
Insomnia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Anxiety disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83 Psychoses. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86 Mood disorders, bulimia nervosa, OCD . . . . . . . . . . . . . 94 Nausea, vomiting, vertigo. . . . . . . . . . . . . . . . . . . . . . . 110 Epilepsy, seizures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114 Parkinson’s, Alzheimer’s and MS . . . . . . . . . . . . . . . . . 120 ADHD, narcolepsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
4.
Analgesia
4.1 4.2
Pain, pyrexia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Migraine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144
5.
Rheumatology
5.1 5.2 5.3 5.4 5.5 5.6
Pain and inflammation of musculo-skeletal system . . Severe active rheumatoid arthritis. . . . . . . . . . . . . . . . Prophylaxis and treatment of gout . . . . . . . . . . . . . . . Muscle spasm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical and intra-articular analgesia . . . . . . . . . . . . . . Myasthenia gravis . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6.
Hormones
6.1
Hypogonadism, erectile dysfunction, other sexual disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Corticoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Growth failure and acromegaly . . . . . . . . . . . . . . . . . . Diabetes mellitus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thyroid hormones and antithyroid drugs . . . . . . . . . . Paget’s disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pituitary disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
19 31 38 40 63 64 71 72 78
146 152 154 156 158 160
Antiviral drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 212
9.
Immunology
9.1 9.2
Vaccines and immunoglobulin products . . . . . . . . . . . 221 Immunological drugs. . . . . . . . . . . . . . . . . . . . . . . . . . . 226
10.
Dietetics
10.1 10.2 10.2 10.4 10.5 10.6
Tonics and bitters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anaemias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Vitamins and Dietary Supplements . . . . . . . . . . . . . . . Metabolism disorders and obesity . . . . . . . . . . . . . . . . Foods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
228 228 228 232 233 234
11.
Respiratory
11.1 11.2 11.3
Bronchodilators, other anti-asthmatics . . . . . . . . . . . . 244 Cough preparations. . . . . . . . . . . . . . . . . . . . . . . . . . . . 251 Respiratory stimulants . . . . . . . . . . . . . . . . . . . . . . . . . . 254
12.
Otolaryngology
12.1 12.2 12.3
Nasal preparations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254 Oropharyngeal preparations . . . . . . . . . . . . . . . . . . . . 256 Aural preparations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259
13.
Ophthalmology
13.1 13.2 13.3 13.4 13.5
Anti-infective eye preparations . . . . . . . . . . . . . . . . . . Anti-inflammatory eye preparations . . . . . . . . . . . . . . Glaucoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ocular lubricants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mydriatics, anaesthetics and stains . . . . . . . . . . . . . . .
259 260 263 266 267
14.
Allergy
14.1
Anti-allergic drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 268
15.
Dermatology
15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9
Emollients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anti-infective topical skin preparations. . . . . . . . . . . . Scabies treatments. . . . . . . . . . . . . . . . . . . . . . . . . . . . . Psoriasis and eczema preparations . . . . . . . . . . . . . . . Acne and rosacea preparations . . . . . . . . . . . . . . . . . . Wart treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Wound management . . . . . . . . . . . . . . . . . . . . . . . . . . Topical corticosteroids. . . . . . . . . . . . . . . . . . . . . . . . . . Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
16.
Contraception
16.1 16.2 16.3 16.4 16.5
Combined oral contraceptives . . . . . . . . . . . . . . . . . . . Progestogen-only contraceptives . . . . . . . . . . . . . . . . . Long-term contraceptives . . . . . . . . . . . . . . . . . . . . . . . Emergency contraception . . . . . . . . . . . . . . . . . . . . . . . Transdermal contraceptives . . . . . . . . . . . . . . . . . . . . .
271 272 274 275 278 281 281 282 284
285 286 286 287 287
160 163 164 166 173 174 174
17.
Obstetrics and gynaecology
7.
Urology
17.1 17.2 17.3 17.4 17.5 17.6 17.7
Dysmenorrhoea . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Menorrhagia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Endometriosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Breast disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Menopausal disorders, osteoporosis . . . . . . . . . . . . . . Obstetrics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.1 7.2 7.3
Genital infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 175 Urinary tract infections . . . . . . . . . . . . . . . . . . . . . . . . . 178 Renal and bladder disorders. . . . . . . . . . . . . . . . . . . . . 178
18.
Toxicology
18.1
Toxicology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303
8.
Anti-infectives
19.
Diagnostic agents
8.1 8.2 8.3 8.4 8.5
Antibacterial drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antifungal drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antituberculous and antileprotic drugs. . . . . . . . . . . . Antimalarial drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Anthelmintic and amoebicide drugs . . . . . . . . . . . . . .
19.1
Diagnostic agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308
6.2 6.3 6.4 6.5 6.6 6.7
188 204 209 210 212
287 288 290 291 293 300 301
20.
Neoplastic disorders
20.1
Neoplastic disorders. . . . . . . . . . . . . . . . . . . . . . . . . . . . 310
Products in MIMS Ireland are arranged into therapeutic categories according to their indications to allow prescribers to locate and compare products that may be used for the same conditions. Products with indications in different therapeutic areas have a separate entry in each section as applicable.
ii
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, A14.07; 20mg-28, A22.35. 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, A11.59; 30mg-28, A22.69. 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
2MO 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.
ALIMENTARY SYSTEM
diarrhoea, headache, rash. Transient CNS effects.
LANZIOP
Teva
2MO
PPI. Lansoprazole 15mg, 30mg. White/redbrownish and white gel caps., resp. 15mg-28, A13.60; 30mg-28, A27.12. S Duodenal and gastric ulcer. Reflux oesophagitis (RO), long-term prophylaxis of RO. 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. ZES: Initially 60mg once daily. Individually adjust and continue as long as necessary. Max. 180mg, if daily dose q 120mg admin. in 2 divided doses. Impaired renal function/ mildly impaired hepatic function: Max. 30mg daily. Moderately impaired hepatic function: Max. 15mg daily. R 15-30mg. Max. 30mg daily. Q Not recommended. D Severely impaired hepatic function. Pregnancy, lactation (no data). IMOGAS McNeil Healthcare B Exclude possibility of malignant gastric tumour. Caution: Hepatic dysfunction. Risk of GI 2K infections. Treatment q 1 year: Review regularly, Deflatulent. Simeticone 240mg. Egg-shaped if visual disturbances occur consult transparent soft cap. 10, A2.55. ophthalmologist. Gastro-duodenal ulcers, consider S Symptomatic treatment of abdominal H. pylori infection as an etiological factor. distension (flatulence) in adults from the age of Contains sucrose. Driving/using machines. 15 years. C Avoid: Ketoconazole, itraconazole. P 1 cap. at the end of each main meal Caution: CYP2C19 and CYP3A4 inhibitors and with a glass of water. Duration: Restricted to 10 substrates (e.g. theophylline, carbamazepine). days. Digoxin, tacrolimus, phenytoin, warfarin. Antacids B If symptoms persist or worsen, or and sucralfate (take 1 hr apart). prolonged constipation occurs, patient should seek A GI disorders, eczema, urticaria, itching, medical advice. Not recommended for infant colic. rash, headache, dizziness, fatigue. A Nausea, constipation, hypersensitivity reactions. LANZOL Rowex
D Severely impaired hepatic function. Pregnancy, lactation (no data). B Exclude possibility of malignant gastric tumour. Caution: Hepatic dysfunction. Risk of GI infections. Treatment q 1 year: Review regularly, if visual disturbances occur consult ophthalmologist. Contains sucrose. Driving or using machines. C Avoid: Ketoconazole, itraconazole. Caution: CYP2C19 inhibitors, CYP3A4 inhibitors and substrates, digoxin, tacrolimus, phenytoin, warfarin. Antacids and sucralfate (take one hour apart). A GI disorders, eczema, urticaria, itching, headache, dizziness, fatigue.
LANZOPRAZOLE BENTLEY
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; 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. INFACOL Ocean 2 M O Individually adjust up to 180mg and continue as PPI. Lansoprazole 15mg, 30mg. Opaque, yellow 2 long as necessary. Doses q120mg daily should be and white gelatine caps. resp. 15mg-28, A12.42; Deflatulent. Activated dimethicone (as divided in two. Eradication of Hp: 30mg twice 30mg-7, A6.17; 30mg-28, A24.68. simethicone) 40mg/ml. Emulsion. 50ml, A2.96. daily for 7 days in combination with one of the S Duodenal and gastric ulcer. Reflux S Relief of griping pain, colic or wind for oesophagitis (RO), long-term prophylaxis of RO. following: Clarithromycin 250-500mg twice daily swallowed air. and amoxicillin 1g twice daily or clarithromycin Eradication of H. pylori (Hp) in combination with P Not applicable. 250mg twice daily and metronidazole 400-500mg antibiotic therapy and prevention of relapse. Q Infants, 20mg (0.5ml) before each feed Zollinger-Ellison syndrome (ZES). NSAID-associated twice daily. Moderate or severe hepatic increasing to 40mg (1ml) if necessary. A impairment: Use half dose. benign gastric and duodenal ulcers (maintenance progressive improvement in symptoms may occur R Max. 30mg daily. and treatment). GORD. over several days. Q Not recommended. P Ulcers and RO: 30mg once daily swallowed whole with liquid into empty stomach; B Exclude possibility of malignant gastric KLACID FORTE Abbott duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 tumour. Teatment q1 year (assess risk/benefit). 2NO weeks; double duration if not fully healed. NSAID- Contains sucrose. Pregnancy, lactation (not recommended). Macrolide. Clarithromycin 500mg. Yellow oval associated ulcers: 30mg once daily for 4 or 8 film-ctd tab. marked with logo. 14, A20.22. weeks; longer course or higher dose may be used C Contra: Atazanavir. Avoid ketoconazole, S Eradication of H. pylori in patients with if severe. Prophylaxis of RO and NSAID-associated itraconazole. Caution: Digoxin, CYP3A4 substrates, theophylline, tacrolimus, fluvoxamine, CYP2C19 duodenal ulcer, in conjunction with anti-secretory ulcers: 15mg once daily; may be increased up to agent. 30mg daily. Eradication of Hp: 30mg twice daily in and CYP3A4 inducers (e.g. rifampicin, St John’s wort), antacids, sucralfate (1 hr apart). P Triple therapy vs H. pylori, 500mg twice combination with recommended antibiotics. ZES: A Headache, dizziness, GI disorders, rash, daily with amoxycillin 1g twice daily and a PPI (at Initially 60mg once daily. Individually adjust and the approved daily dose) for 7-10 days. Dual continue as long as necessary. Max. 180mg, if daily urticaria, itching, fatigue. Increase in liver enzyme levels. therapy vs H. pylori eradication, 500mg three dose q 120mg admin. in 2 divided doses. GORD: times daily for 14 days with an acid suppressant. 15-30mg once daily for up to 4 weeks. If LOPRAZ Teva Q Not recommended. symptoms persist after 4 weeks on 30mg further 2MO B Renal or hepatic impairment. Pregnancy, examination recommended. Impaired renal PPI. Omeprazole 10mg, 20mg, 40mg. Opaque lactation. function/ mildly impaired hepatic function: Max. C Theophylline, oral anticoagulants, 30mg daily. Moderately impaired hepatic function: yellow caps. containing gastro-resistant granules. 10mg-28, A13.10; 20mg-28, A24.61; 40mg-14, carbamazepine, digoxin, terfenadine, drugs Max. 15mg daily. A24.65. metabolised by P450. R 15-30mg. Max. 30mg daily. A Nausea, vomiting, abdominal pain and S Duodenal ulcer, benign gastric ulcers, Q Not recommended.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM reflux oesophagitis (RO, maintenance and treatment), GORD, Zollinger-Ellison syndrome (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 gastric and duodenal 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 400500mg, 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. Renal dysfunction, severe hepatic impairment (monitor liver function). Long-term treatment. Contains sucrose. Pregnancy, lactation (only if benefit outweighs risk). C Clarithromycin (do not use if hepatic impairment), St. John’s wort (avoid). Caution: Diazepam, some other benzodiazepines, warfarin, phenytoin, other CYP2C substrates, disulfiram, cyclosporin, clarithromycin, ketoconazole or itraconazole, digoxin, vit. B12. A Drowsiness, somnolence, sleep disturbances, vertigo and headaches, GI disorders.
GORD, prolonged treatment, patients should be reviewed periodically by a consultant. C Diazepam, phenytoin, warfarin, ketoconazole, itraconazole, digoxin, clarithromycin, roxithromycin, erythromycin, hexabarbital, citalopram, imipramine, clomipramine, disulfiram, cyclosporin, vitamin B12. A Headache, vertigo, drowsiness, sleep disturbances, GI upset, paraesthesia, changes in liver function, hypersensitivity (skin rash). Leucopenia and thrombocytopenia have been reported.
ULCERS, IRRITABLE BOWEL
LOSEPINE
1.1 Pinewood
2MO
PPI. Omeprazole 10mg, 20mg. Oval red-brown gastro-resistant tab. 10mg-28, A14.50; 20mg-28, A27.38. S Duodenal ulcer, benign gastric ulcers, reflux oesophagitis (maintenance and treatment), GORD, Zollinger-Ellison syndrome (ZES), history of ulcer following use of anti-inflammatory products, NSAID related gastric and duodenal ulcers (maintenance and treatment). In combination with antibacterial regimens for eradication of H.pylori LOSEC MUPS AstraZeneca associated peptic ulcers. P Swallow tab. whole with sufficient fluid 2MO before meal or on empty stomach. Duodenal PPI. Omeprazole 10mg, 20mg, 40mg. Light pink, ulcers: 20mg once daily during 2-4 weeks. pink and red-brown tabs resp. All oblong, film-ctd Maintenance: 10mg daily. Gastric ulcers: 20mg marked with tab. strength and containing ent-ctd daily during 4-(6)-8 weeks. RO: 20mg daily during pellets. Dispersible in water. 10mg-28, A14.56; 4-8 weeks. Maintenance: 10-20mg daily. All three 20mg-28, A27.41; 40mg-14, A27.39. conditions, increase to 40mg once daily if S Treatment of oesophageal reflux (OR) necessary. GORD: 10-20mg daily during 2-4 weeks. disease, incl. reflux oesophagitis (RO). Treatment ZES: Initially, 60mg daily. Adjust individually. of duodenal and benign gastric ulcers. Healing Above 80mg daily, admin. in two divided doses. and prophylaxis of NSAID-associated benign No time limit. NSAID related gastric and duodenal ulcers: 20mg daily during 4-8 weeks. Maintenance: gastric ulcers and duodenal ulcers. H. pylori 20mg daily. Eradication: 20mg with amoxicillin eradication in peptic ulcer disease. Relief of associated dyspeptic symptoms. Prophylaxis of acid 1000mg and clarithromycin 500mg, or 20mg with clarithromycin 250mg and metronidazole 400aspiration. Zollinger-Ellison syndrome (ZES). 500mg, all 2 times daily during 1 week. Impaired P OR: 20mg once daily for 4 weeks. In those unhealed after initial course, healing usually hepatic function: Max. 20mg daily. Q Over 2 years, severe RO only. 10-20kg: occurs during a further 4-8 weeks treatment. 10mg/day; over 20kg: 20mg/day. Duration: 4-8 Refractory RO, 40mg daily for 8 weeks. weeks; max.12 weeks. Under 2 years, not Maintenance of severe RO, 20mg daily increasing recommended. to 40mg once daily if relapse. Acid reflux disease: B Exclude possibility of malignancy. Long term management, 10mg once daily, increasing to 20mg if symptoms return. Duodenal Increased risk of GI infections. Hepatic dysfunction (monitor transaminase levels). Contains lactose. and gastric ulcer: 20mg daily usually for 4-8 Pregnancy, lactation. weeks. Increase to 40mg once daily if severe. Maintenance, 10mg once daily increasing to 20mg C Caution: Ketoconazole or itraconazole, diazepam, R-warfarin and phenytoin, digoxin, LOSAMEL Clonmel once daily if symptoms return. NSAID ulceration: erythromycin and roxitromycin. 2MO For healing and prophylaxis 20mg once daily. Hp A Dizziness, somnolence, insomnia, PPI. Omeprazole 20mg. Light grey gastro-resistant eradication: Triple therapy, Losec 20mg with vertigo, sense of malaise and headache, GI tab. (tabs. must not be broken). 30, A28.12. clarithromycin 250mg and metronidazole 400mg disorders. S Treatment of duodenal ulcer, benign or amoxycillin 1g and clarithromycin 500mg all gastric ulcers, reflux oesophagitis, Zollinger-Ellison twice a day for 1 week. Dual therapy, Losec 20mg MAALOX sanofi-aventis syndrome, treatment of NSAID-related gastric and with oral amoxycillin 1g both twice daily for 2 2O duodenal ulcers, gastro-oesophageal reflux weeks. Alternatively, Losec 40mg once daily with Antacid. Alum. hydrox. gel 225mg, mag. hydrox. disease, in combination with appropriate clarithromycin 500mg three times daily for 2 200mg/5ml. Susp. 500ml, A5.00. antibacterial therapeutic regimens for the weeks. Acid aspiration: 40mg on evening before S Dyspepsia. eradication of Helicobacter pylori in patients with surgery followed by 40mg 2- 6 hrs prior to P 5-10ml (1-2 spoonfuls) taken 20-60 mins. H. pylori associated peptic ulcers. surgery. ZES: Initially 60mg, adjusting at 20-120mg after meals and at night. P Duodenal ulcer: 20mg once daily; daily. Doses above 80mg, twice daily. 2 healing usually occurs within 2-4 weeks. Benign Q Treatment of refractory RO, 10mg (10gastric ulcers and RO: 20mg once daily; healing 20kg) or 20mg (q20kg) once daily for 4-12 weeks. usually occurs within 4-8 weeks. Maintenance 2N treatment of reflux oesophagitis: 10-20mg daily. ALSO LOSEC INFUSION Omeprazole 40mg (as Zollinger-Ellison syndrome: See SmPC. NSAID ulceration: 20mg once daily; healing usually occurs omeprazole Na+ 42.6mg). Powder in vial. 40mg-5, A43.48. within 4-8 weeks; maintenance 20mg once daily. Gastro-oesophageal reflux disease: 10-20mg daily. P Where oral medication inappropriate, The information published 40mg once daily as IV inf. over 20-30 mins. Acid Healing usually occurs within 2-4 weeks. H. pylori in the editorial listing in eradication regimens in peptic ulcer disease: 20mg aspiration: 40mg as IV inf. one hour before surgery. Only reconstitute powder in 100ml saline twice daily in association with the following MIMS Ireland is based upon or 100ml dextrose (5%) for inf. regimens amoxicillin 1000mg and clarithromycin details supplied by the Q Not recommended. 500mg both twice daily for one week or B Pregnancy and lactation. Severe liver manufacturers.The Index clarithromycin 250mg and metronidazole 400disease. In gastric ulcer exclude malignancy before 500mg both twice daily for one week. Tabs. lists preparations which are treatment. With prolonged treatment, review should be swallowed whole before a meal. available on prescription in Q Severe RO resistant to other therapeutic patients periodically. measures: 10mg (10-20 kg) or 20mg (q20 kg) once C Contra: Atazanavir. Ketoconazole, general practice. itraconazole, clarithromycin, tacrolimus. diazepam, daily. phenytoin, warfarin and other vitamin K B Avoid use during pregnancy and antagonists. lactation. Severe liver disease. In gastric ulcer exclude malignancy before treatment. With A Headache, GI upset.
EDITORIAL INFORMATION
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
5
1.1 GORD,
ULCERS, IRRITABLE BOWEL
ALSO MAALOX NO. 2 TABLETS Dried alum. hydrox. gel 400mg, mag. hydrox. 400mg. White tab. marked WHR both sides with odour of peppermint. 40, A3.45. S Dyspepsia. P 1-2 four times daily chewed 20-60 mins. after meals and at bedtime. Max. 8 in 24 hrs. not more than 2 weeks unless indicated by physician. Q Not recommended.
ALIMENTARY SYSTEM
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.
C Anticholinergics, CYP3A4 inhibitors, antacids or antisecretory agents, phenothiazines or other neuroleptics, dopaminergic agonists. A Raised serum prolactin.
NEXIUM
AstraZeneca
2MO
PPI. Esomeprazole (magnesium trihydrate) 20mg, 40mg. Pink oblong film-ctd tabs. marked 20mg or 40mg one side and symbol on reverse. 20mg-28, ALSO MAALOX PLUS SUSP Alum. hydrox. gel A26.72; 40mg-28, A41.23. 225mg, mag. hydrox. 200mg, simethicone 25mg/ S Treatment of erosive reflux oesophagitis 5ml. Susp. 355ml, A5.00. (RO); long-term management of patients with S Heartburn, indigestion, flatulence and healed oesophagitis to prevent relapse; MOTILIUM McNeil Healthcare dysepsia. symptomatic treatment of gastroesophageal reflux P 1-2 x 5ml spoonfuls four times a day 2K disease (GORD). Healing of H. pylori (Hp) (after meals and at bedtime) or as required. associated duodenal ulcer. Prevention of Hp Antidopaminergic. Domperidone 10mg. White to 2 associated peptic ulcer relapse. Patients requiring faintly cream circular biconvex film-ctd tabs. 10, A3.67; 20, A6.43. continued NSAID therapy: Healing of gastric ulcers ALSO MAALOX PLUS TABLETS Alum. hydrox. associated with NSAID therapy, and prevention of 200mg, mag. hydrox. 200mg, simethicone 25mg. 2K Yellow/white tab. marked MAALOX on one side ALSO MOTILIUM FASTMELTS Domperidone 10mg. gastric and duodenal ulcers associated with NSAID and RORER on reverse. 20, A2.84; 50, A5.25. White or off-white circular orodispersible tab. 10, therapy in at risk patients. Treatment of Zollinger Ellison Syndrome (ZES). Prolonged treatment after S Heartburn, indigestion, flatulence and A3.99; 20, A7.00. IV induced prevention of rebleeding of peptic dysepsia. S Post-prandial symptoms of fullness, ulcers. P 1-2 tabs. four times a day (after meals nausea, epigastric bloating and belching and at bedtime) or as required. occasionally accompanied by epigastric discomfort P Erosive RO: Treatment, 40mg once daily for 4 weeks; additional 4 weeks for patients not Q Not recommended. and heartburn. healed. Prevention of relapse, 20mg once daily. D Severely debilitated patients. Kidney P Up to 10mg 3 times daily and at night GORD without oesophagitis: 20mg once daily until failure. Pregnancy (unless essential). for 2 weeks max. B Advance renal disease, low phosphate Q Under 16 years, not recommended. Over symptom resolution; maintenance 20mg once daily when required. In adults, an on demand regimen diet e.g. malnutrition. 16 years, as per adults. taking 20mg once daily, when needed, can be C Caution: Tetracyclines, digoxin and D Prolactin-releasing pituitary tumour used. Healing/ prevention of Hp associated ulcers: vitamins. (prolactinoma). GI haemorrhage, mechanical 20mg with 1g amoxycillin and 500mg obstruction or perforation. Hepatic and/or renal MAXOLON Amdipharm impairment. Pregnancy, lactation. clarithromycin, all twice daily for 7 days. NSAID induced ulcers: Treatment, 20mg once daily for 4-8 B Contains aspartame. 2MO weeks; prevention, 20mg once daily. ZES: 40mg C Strong CYP3A4 inhibitors (e.g. Antidopaminergic. Metoclopramide twice daily. Usual range 80-160mg daily. Doses q ketoconazole, ritonavir, erythromycin). monohydrochlor. 10mg. White to off-white scored 80mg daily, divide and admin. twice-daily. After IV A Raised serum prolactin. tab. marked MAXOLON. 84, A6.36. induced prevention of rebleeding of peptic ulcers: 2MO 40 mg once daily for 4 weeks. Severe renal MOTILIUM RX McNeil Healthcare ALSO MAXOLON SYRUP Metoclopramide (HCl) impairment: Max. 20mg once daily. 2OY 5mg/5ml. 100ml, A1.60; 200ml, A3.20. Q Over 12 years, RO and GORD only, as Antidopaminergic. Domperidone 10mg. White 2NO per adults. Under 12 years, not recommended. film-ctd tab. marked M/10 on one side and ALSO MAXOLON INJECTION Metoclopramide 2 JM JANSSEN on reverse. 100, A 6.04. (HCl) 5mg/2ml. Amp 12 x 5mg, A3.46. ALSO NEXIUM I.V. 40MG Esomeprazole (sodium) S Adults over 20 years: Disorders of the GI S Disorders of GI tract associated with delayed gastric emptying and oesophageal reflux. 42.5mg (equiv. esomeprazole 40mg). Powder in tract associated with delayed gastric emptying vial for soln. for inj. or inf. 40mg-1, A7.98. P 10mg orally, 3 times daily, 15-30 mins (e.g. reflux oesophagitis, hiatus hernia, postS GORD in patients with esophagitis and/ before meals and if necessary before retiring. vagotomy syndrome). Diagnostic procedures (e.g. or severe symptoms of reflux as an alternative to Q Under 1 year, under specialist barium studies and duodenal intubations). To oral therapy. Healing of gastric ulcers associated counteract gastric stasis associated with attacks of supervision. with NSAID therapy. Prevention of gastric and 2MO migraine and assist absorption of orally duodenal ulcers associated with NSAID therapy in ALSO MOTILIUM SUSPENSION Domperidone 1mg administered analgesics for that condition. Under patients at risk. Prevention of rebleeding per ml. Oral susp. 200ml, A2.08. 20 years: As an aid to GI intubation. following therapeutic endoscopy for acute S Epigastric sense of fullness, upper P 10mg three times daily. Q60kg, see bleeding gastric or duodenal ulcers. abdominal discomfort and regurgitation of gastric P IV inj. over 3 mins. or IV inf. over 10below. Diagnostic indications: Single 10-20mg contents in adults. dose, 5-10 min before examination. 30mins. RO: 40mg once daily. Symptomatic Q Medical indications: 15-19 years q60kg, P 10ml-20ml 3-4 times per day before treatment for reflux disease/healing and 10mg three times daily; 30-59kg, 5mg three times meals. Max. 80ml. Reevaluate after 4 weeks. prevention of NSAID-associated ulcers: All 20mg daily; 9-14 years r30kg, 5mg three times daily; 5- 2 M O once daily. Transfer to oral as soon as possible. 9 years 20-29kg, 2.5mg three times daily; 3-5 years ALSO MOTILIUM SUPPOSITORIES Domperidone Prevention of rebleeding after endoscopy: 80mg A 10mg, 30mg, 60mg. 10mg-6, 1.80; 30mg-6, 15-19kg, 2mg two to three times daily; 1-3 year as bolus inf. over 30 min, followed by IV inf. of A1.81; 60mg-6, A7.31. 10-14kg, 1mg two to three times daily; Q1year 8mg/h over 72 hrs, then by oral acid-suppression Q10kg, 1mg twice daily. Diagnostic indications: 5- S Epigastric sense of fullness, upper therapy. Severe liver impairment: GORD, max. 10 min before examination. 15-19 years, 10mg; 9- abdominal discomfort and regurgitation of gastric 20mg daily; rebleeding prevention, 4mg/h for 71.5 contents in adults. 14 years, 5mg; 5-9 years, 2.5mg; 3-5 years, 2mg; hours may be sufficient. P 1 (60mg) suppos. twice daily. Reevaluate Q Not recommended. Q3 years, 1mg. after 4 weeks. D Phaeochromocytoma. Epilepsy. GI D Hypersensitivity to other substituted D Pregnancy (unless essential), lactation. haemorrhage, mechanical obstruction or benzimidazoles. Lactation. perforation. Pregnancy, lactation (unless essential). Patients with prolactin releasing pituitary tumours, B In gastric ulcer exclude malignancy GI haemorrhage, mechanical obstruction or before treatment. Long term treatment (monitor). perforation. Hepatic impairment. B Not for use in the immediate postSevere hepatic/renal insuffiency. Slightly increased B Severe renal insufficiency, especially if operative period (up to 3-4 days) following risk of GI infections (Salmonella, Campylobacter). Pregnancy. Contains lactose. pyloroplasty or gut anastomosis. Assess risk/benefit: prolonged use.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ALIMENTARY SYSTEM
GORD,
ULCERS, IRRITABLE BOWEL
1.1
Q Under 12 years, not recommended. Over 500mg twice daily or clarithromycin 500mg + 12 years: Mild reflux disease, RO: As per adults. metronidazole 500mg twice daily or amoxicillin 1g twice daily + metronidazole 500mg twice daily. 2MO Impaired renal function: Max 40mg daily. Severe ALSO PANTIUM 40MG Pantoprazole 40mg. Yellow oval gastro-resistant tab. 40mg-28, A22.73. hepatic impairment: Max 40mg every other day. R Max 40mg daily except for H.pylori S Combination therapy with 2 suitable eradication (as per adults for 1 week). antibiotics for eradication of H. pylori and OMEPRAZOLE BENTLEY Bentley prevention of relapse of peptic ulcers in patients Q Under 12 years, not recommended. Over 12 years: RO: As per adults. with H. pylori associated ulcers; duodenal ulcers; 2MO D Moderate to severe liver or renal PPI. Omeprazole 10mg, 20mg, 40mg. Opaque red/ gastric ulcers; moderate or severe forms of RO; long-term treatment of Zollinger-Ellison syndrome insufficiency (40mg tab. in combination therapy to orange, blue/orange, blue/orange caps. marked eradicate H. pylori). For prescribing information, (ZES) and other disorders accompanied by O10, O20, O40 resp. containing gastro-resistant see pantoprazole Drug Presc. Notes. pathological gastric acid hypersecretion. granules. 10mg-28, A11.05; 20mg-28, A17.99; P RO: 40mg daily; may be doubled. H. 40mg-14, A18.84. PANTOPRAZOLE NICHE Niche pylori eradication: 40mg twice daily in S Duodenal ulcer, benign gastric ulcers, combination with either amoxicillin 1g twice daily 2 M O reflux oesophagitis (RO, maintenance and + clarithromycin 500mg twice daily or treatment), GORD, Zollinger-Ellison syndrome PPI. Pantoprazole 20mg. Light brownish yellow, clarithromycin 250-500mg + metronidazole 400(ZES), NSAID related gastric and duodenal ulcers oval, slightly biconvex gastro-resistant tab. 28, A11.46. (maintenance and treatment). In combination with 500mg twice daily or amoxicillin 1g twice daily + metronidazole 400-500mg twice daily. Gastric/ antibacterial regimens for eradication of H. pylori S Mild reflux disease and associated duodenal ulcers: 40mg daily. ZES: Initially 80mg associated peptic ulcers. symptoms. Long-term management and P Swallow tab. whole with sufficient fluid daily. Doses q80 mg daily, divide dose and give prevention of relapse in reflux oesophagitis (RO). twice daily. May be temporarily increased to before meal. Duodenal ulcers: 20mg once daily Prevention of gastroduodenal ulcers induced by q160mg (no longer than required for adequate during 2-4 weeks. Gastric ulcers: 20mg daily during non-selective non-steroidal anti-inflammatory acid control); maintain as long as required. drugs (NSAIDs) in patients at risk with need for 4-(6)-8 weeks. RO: 20mg daily during 4-8 weeks; continuous NSAID treatment. maintenance, 10-20mg daily. All three conditions, Impaired liver function: Max 40mg every other day. P Mild reflux disease: 20mg daily; control increase to 40mg once daily if necessary. GORD: R Max 40mg daily except for H.pylori recurrent symptoms with 20mg once daily on10-20mg daily during 2-4 weeks. ZES: Initially, eradication (as per adults for 1 week). demand regimen if required; consider switching to 60mg daily. Adjust individually. Above 80mg daily, continuous therapy if symptoms not controlled admin. in two divided doses. No time limit. NSAID Q Not recommended. D Severe hepatic insufficiency adequately. RO (long-term, prevention of relapse): related ulcers: 20mg daily during 4-8 weeks. 20mg daily; increase to 40mg daily if relapse Maintenance: 20mg daily. Eradication: 20mg with (combination therapy for H. pylori eradication). For prescribing information, see pantoprazole occurs. NSAID-induced gastroduodenal ulcers: amoxicillin 1000mg and clarithromycin 500mg, or Drug Presc. Notes. 20mg daily. Impaired renal function: Max 40mg 20mg with clarithromycin 250mg and daily. Severe hepatic impairment: Max 20mg daily. metronidazole 400-500mg, all 2 times daily during B Contains maltitol. 1 week. Impaired hepatic function: Max. 20mg PANTOFLUX Actavis R Max 40mg daily. daily. Q Not recommended. Q Over 2 years, severe RO only. 10-20kg: 2MO 2MO 10mg/day; over 20kg: 20mg/day. Duration: 4-8 PPI Pantoprazole 20mg. Elliptical biconvex light ALSO PANTOPRAZOLE NICHE 40MG Pantoprazole weeks; max.12 weeks. Under 2 years, not yellow gastro-resistant tab. 28, A13.08. 40mg. Light brownish yellow, oval, slightly recommended. S Treatment of mild reflux disease and B Exclude possibility of malignancy. Severe associated symptoms; long-term management and biconvex gastro-resistant tab. 28, A21.22. S Relief of symptoms and short-term hepatic impairment (monitor liver function). Long- prevention of relapse in reflux oesophagitis (RO); treatment of GI diseases which require a reduction term treatment (q1 year). Contains sucrose. prevention of gastroduodenal ulcers induced by Pregnancy, lactation (only if benefit outweighs non-selective NSAID in patients at risk with a need in acid secretion: Duodenal ulcer, gastric ulcer, moderate and severe RO, eradication of H. pylori risk). for continuous NSAID treatment. C Contra: Atazanavir, clarithromycin (in P Mild reflux disease: 20mg daily; control in combination with antibiotic therapy in patients with peptic ulcer, Zollinger-Ellison syndrome and hepatic impairment). Avoid St. John’s wort, recurrent symptoms with 20mg once daily onketoconazole itraconazole. Caution: Diazepam, demand regimen if required; consider switching to other hypersecretory conditions. P Moderate to severe RO/ duodenal/ some other benzodiazepines, warfarin, phenytoin, continuous therapy if symptoms not controlled gastric ulcer: 40mg daily. H. pylori eradication: other CYP2C substrates, disulfiram, cyclosporin, adequately. RO: 20mg daily; increase to 40mg tacrolimus, clarithromycin, digoxin, vit. B12. daily if relapse occurs. NSAID-induced ulcers: 20mg 40mg twice daily in combination with either amoxicillin 1g twice daily + clarithromycin 500mg A Drowsiness, dizziness, somnolence, sleep daily. Severe liver impairment: Max 20mg daily. disturbances, headaches, GI disorders. Q Under 12 years, not recommended. Over twice daily or clarithromycin 250-500mg + metronidazole 400-500mg twice daily or 12 years: Mild reflux disease, RO: As per adults. amoxicillin 1g twice daily + metronidazole 400PANTIUM Clonmel 2 M O 500mg twice daily. ZES: Initially 80mg daily. Doses 2MO ALSO PANTOFLUX 40MG Pantoprazole 40mg. q80 mg daily, divide dose and give twice daily. Elliptical biconvex dark yellow gastro-resistant tab. PPI. Pantoprazole 20mg. Yellow oval gastroMay be temporarily increased to q160mg (no 28, A24.17. resistant tab. 20mg-28, A12.27. longer than required for adequate acid control). S Mild reflux disease and associated S Symptomatic improvement and healing Impaired renal function: Max 40mg daily. Severe symptoms; long-term management and prevention of GI diseases requiring a reduction in acid hepatic impairment: Max 40mg every other day. of relapse in reflux oesophagitis (RO); prevention secretion: Duodenal ulcer, gastric ulcer, moderate R Max 40mg daily except for H.pylori of gastroduodenal ulcers induced by non-selective and severe RO, Zollinger-Ellison-Syndrome (ZES) eradication (as per adults for 1 week). NSAID in patients at risk with need for continuous and other pathological hypersecretory conditions, Q Not recommended. NSAID treatment. eradication of Helicobacter pylori (in combination B For prescribing information, see P Mild reflux disease: 20mg daily. Control with antibiotics in patients with duodenal ulcer or pantoprazole Drug Presc. Notes. Contains sorbitol. recurrent symptoms with 20mg once daily ongastric ulcer). demand regimen if required; if symptoms not P RO: 40mg daily. Duodenal/gastric ulcer: PANTOPRAZOLE RANBAXY controlled adequately consider switch to 40mg daily. ZES: Initially 80mg daily. Doses q80 Ranbaxy continuous therapy. RO: 20mg daily; increase to mg daily, divide dose and give twice daily. May be 40mg daily if relapse occurs. Carefully analyse risk/ temporarily increased to q160mg (no longer than 2 M O PPI. Pantoprazole 20mg. Yellow enteric-ctd oval benefit for treatment q1 year. NSAID-induced required for adequate acid control). H. pylori ulcers: 20mg daily. Impaired liver function: Max eradication: 40mg twice daily in combination with shaped, biconvex tab. marked P 20 on one side. 28, A8.18. 20mg daily . either amoxicillin 1g twice daily + clarithromycin 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
7
1.1 GORD,
ULCERS, IRRITABLE BOWEL
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 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.
ALIMENTARY SYSTEM
40mg (as Na+ sesquihydrate). Light brownishyellow, oval, slightly biconvex gastro-resistant tab. 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.
insufficiency (40mg tab. in combination with antibiotic therapy). For prescribing information, see pantoprazole Drug Presc. Notes. B Contains Ponceau 4R aluminium lake.
PARIET
Janssen-Cilag
2MO
PPI. Rabeprazole (Na ) 10mg, 20mg. Pink tab. and yellow tab. resp. Both ent-ctd. 10mg-28, A17.58; 20mg-28, A27.56. S Active duodenal ulcer, active benign gastric ulcer and symtomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD). Long term maintenance of patients with GORD. Symptomatic treatment of moderate to very severe GORD. Zollinger-Ellison Syndrome (ZES). In combination with appropriate antibacterial 2MO regimens for the eradication of Helicobacter pylori ALSO PANTOPRAZOLE RANBAXY 40MG in patients with peptic ulcer disease. Pantoprazole 40mg. Yellow enteric-ctd oval P Swallow tab. whole in the morning PANTUP Rowex before eating. Active duodenal or benign gastric shaped, biconvex tab. marked P 40 on one side. 28, A15.14. 2MO ulcer, 20mg once daily for 4-6 weeks. Erosive or S Moderate and severe reflux ulcerative GORD, 20mg once daily for 4-8 weeks. PPI. Pantoprazole 20mg. Yellow oval ctd tabs. oesophagitis. Duodenal ulcer. Gastric ulcer. Maintenance, 10-20mg once daily. Symptomatic imprinted 20 in black. 20mg-28, A10.82. Zollinger-Ellison syndrome (ZES) and other GORD, 10mg once daily in patients without S Mild reflux disease and associated pathological hypersecretory conditions. symptoms; long-term management and prevention oesophagitis; once symptoms resolved, subsequent P Moderate to severe RO/ duodenal/ control can be achieved by 10mg once daily taken of relapse in reflux oesophagitis (RO); prevention gastric ulcer: 40mg daily; may be doubled. ZES: of gastroduodenal ulcers induced by non-selective when needed. ZES, initially 60mg once a day; may Initially 80mg daily. Doses q80 mg daily, divide be titrated up to 120mg/day (120mg dose in two NSAID in patients at risk with need for continuous dose and give twice daily. May be temporarily divided dose). Eradication of H. Pylori, 20mg twice NSAID treatment. increased to q160mg (no longer than required for P Mild reflux disease: 20mg daily; control daily for 7 days in combination with adequate acid control). Impaired renal function: clarithromycin 500mg twice daily and amoxycillin reoccurring symptoms with 20mg once daily onMax 40mg daily. Severe hepatic impairment: Max demand if required; consider switch to continuous 1g twice daily. 20mg daily or 40mg every other day. Elderly: Max therapy if symptoms not controlled adequately. Q Not recommended. 40mg daily. D Pregnancy, lactation. RO: 20mg daily; increase to 40mg daily if relapse R Max 40mg daily. B Exclude malignancy, severe hepatic occurs. NSAID-induced gastroduodenal ulcers: Q Under 12 years, not recommended. 20mg daily. Severe hepatic impairment: Max 20mg impairment, long-term treatment. B For prescribing information, see C Caution: Ketoconazole, itraconazole. daily. pantoprazole Drug Presc. Notes. A Headache, GI upset, Infection, insomnia, Q Not recommended. dizziness, cough, pharyngitis, rhinitis, pain/back 2MO PANTOPRAZOLE TEVA Teva ALSO PANTUP 40MG Pantoprazole 40mg. Yellow pain, asthenia, flu-like syndrome. 2MO oval ctd tabs. imprinted 40 in black. 40mg-28, PEPCID MSD PPI inhibitor. Pantoprazole 20mg (as Na+ A20.04. sesquihydrate). Light brownish-yellow, oval, 2MO S Duodenal ulcers; gastric ulcers; slightly biconvex gastro-resistant tab. 20mg-28, moderate or severe RO; Zollinger-Ellison syndrome H2 blocker. Famotidine 20mg beige film-ctd square A12.27. tab. marked MSD 963; 40mg brown film-ctd (ZES) and other disorders involving pathological S Treatment of mild reflux disease and square tab. marked MSD 964. 20mg-28, A16.24. hypersecretion. associated symptoms. Long-term management and P Duodenal /gastric ulcer, RO: 40mg daily; 40mg-28, A30.85. prevention of relapse in reflux oesophagitis (RO). S Duodenal and benign gastric ulcers. dose may be doubled. ZES: Initially 80mg daily. Prevention of gastroduodenal ulcers induced by Prevention of relapse of duodenal ulceration. Doses q80 mg daily, divide dose and give twice non-selective NSAIDs. Zollinger-Ellison syndrome. Prevention and daily. May be temporarily increased to q160mg P Mild reflux disease: 20mg daily. RO: treatment of gastro-oesophageal reflux disease. (no longer than required for adequate acid 20mg daily. Increase to 40mg daily if relapse control). Impaired renal function: Maximum 40mg. P Benign gastric and duodenal ulcer: occurs. NSAID-induced ulcers: 20mg daily. Hepatic Severe hepatic impairment: Maximum 40mg every 40mg at night for 4-8 weeks. Prophylaxis of impairment: Max 20mg daily. duodenal ulcer relapse: 20mg at night. Zollingerother day. Q Not recommended. Ellison syndrome: Initially 20mg every 6 hours, R Maximum 40mg daily. 2MO adjust as necessary; max. 800mg daily. GastroQ Not recommended. ALSO PANTOPRAZOLE TEVA 40MG Pantoprazole oesophageal reflux disease: 20mg twice daily for D Moderate to severe liver or renal +
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
8
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 6-12 weeks; with associated erosion or ulceration, 40mg twice daily for 6-12 weeks. Q Not recommended. D Lactation. B Impaired renal function, gastric carcinoma. Pregnancy. A Headache, dizziness, CNS disturbances, constipation, diarrhoea, dry mouth, nausea, abdominal discomfort, rash, anorexia, fatigue, arthralgia, muscle cramps, liver enzyme abnormalities, cholestatic jaundice, anaphylaxis, angioedema. Rarely toxic epidermal necrolysis, A-V block.
GORD, Caution:Driving/operating machinery, patients at risk of falling blood cell counts. Contains lactose. Pregnancy, lactation. C Oral anticoagulants, phenytoin, theophylline. A Diarrhoea, dizziness, rash, tiredness. Gynaecomastia, occasional reversible liver damage, confusional states, mood/behavioural changes, insomnia. Leucopenia. Very rarely interstitial nephritis with occasional increase in plasma creatinine, acute pancreatitis, thrombocytopenia, headache, myalgia, arthralgia.
ULCERS, IRRITABLE BOWEL
1.1
2MO
ALSO PROTIUM 40MG Pantoprazole 40mg. Yellow, oval biconvex enteric-ctd tab. marked P40 on one side. 28, A16.03. S Moderate and severe reflux oesophagitis. Duodenal ulcer. Gastric ulcer. Zollinger-Ellison syndrome (ZES) and other pathological hypersecretory conditions. Eradication of H. pylori, in combination with two antibiotics in patients with duodenal ulcer or gastric ulcer. P Moderate to severe RO: 40mg daily. Duodenal/gastric ulcer: 40mg daily, may be doubled. ZES: Initially 80mg daily. Doses q80 mg PROTIUM Nycomed daily, divide dose and give twice daily. May be PINAMET Pinewood 2 M O temporarily increased to q160mg (no longer than required for adequate acid control). H. pylori 2MO PPI. Pantoprazole 20mg. Yellow, oval biconvex eradication: 40mg twice daily in combination with H2 blocker. Cimetidine 400mg. Pale, green, oblong film-ctd tab. with P20 in brown ink on one side. either amoxicillin 1g twice daily + clarithromycin A 28, 8.66. bi-convex film-ctd tabs marked 2Y1 on one side. 500mg twice daily or clarithromycin 250mg + 400mg-60, A11.02. S Treatment of mild reflux disease and metronidazole 400mg twice daily. Impaired renal associated symptoms (e.g. heartburn, acid S Benign ulceration of oesophagus, function: Max 40mg daily. Severe hepatic stomach, upper intestinal tract (incl. post-operative regurgitation, pain on swallowing). Long-term impairment: Max 40mg every other day. management and prevention of relapse in reflux stomal area) and the Zollinger-Ellison syndrome. R Max 40mg daily. oesophagitis (RO). Prevention of gastroduodenal Conditions benefitting from reduced gastric acid ulcers induced by non-selective non-steroidal anti- Q Under 12 years, not recommended. excretion. Long term maintenance of benign 2N inflammatory drugs (NSAIDs) in patients at risk peptic ulcer disease under regular surveillance. ALSO PROTIUM IV Pantoprazole 40mg (Na+). with a need for continuous NSAID treatment. P Duodenal ulcer, 400mg twice daily or P Mild reflux disease: 20mg daily; control Powder in vial. 5, A39.21. 800mg at bedtime for min. four weeks; S Duodenal ulcer. Gastric ulcer. Moderate recurrent symptoms with 20mg once daily onmaintenance, 400mg at bedtime or twice daily. demand regimen if required; consider switching to and severe RO. ZES and other pathological Other indications, see SPC. Impaired renal hypersecretory conditions. continuous therapy if symptoms not controlled function; Reduce dosage. Daily dosage, do not adequately. RO (long-term, prevention of relapse): P Reconstitute with 10ml saline for admin. exceed 2400mg. by inj.; alternatively mix with 100ml saline or 5% 20mg daily; increase to 40mg daily if relapse Q Over 2 years, 25-30mg/kg body weight glucose sln, for inf. Switch to tab. as soon as oral occurs. NSAID-induced gastroduodenal ulcers: daily in divided doses. 20mg daily. Severe hepatic impairment: Max 20mg therapy possible. Moderate to severe RO/ B Exclude malignant disease before and duodenal/gastric ulcer: 40mg daily. ZES: Initially daily. during treatment. Impaired renal function. Q Under 12 years, not recommended. Monitor patients on long term therapy. 80mg daily. Doses q80 mg daily, divide dose and
Anti-doping: A Guide for Prescribers Classifications
2.......... This medicinal product is permitted for use in sport. 5.......... This medicinal product contains substance(s) prohibited for use in sport. Athletes requesting to use this product are required to apply for a TUE. m.....
c..... s........ d.......
This medicinal product contains substance(s) prohibited for use in sport, in men only. Male Athletes requesting to use this product are required to apply for a TUE. This medicinal product contains substance(s) prohibited for use in sport during the competition period only. Athletes requesting to use this product in-competition are required to apply for a TUE. 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. This medicine is permitted but should be declared on the Doping Control Form at the time of testing. 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.
b........
*All TUE applications for asthma medications must be accompanied with a medical file meeting the minimum requirements as defined by WADA (refer to www.irishsportscouncil.ie/Anti-Doping) and must reflect current best medical practice to include: 1) A complete medical history in relation to asthma 2) A comprehensive report of the clinical examination with specific focus on the respiratory system 3) A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1) 4) If airway obstruction is present, the spirometry will be repeated after inhalation of a short acting beta-2 agonist to demonstrate the reversibility of bronchoconstriction 5) In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness 6) Exact name, speciality, address (including telephone, e-mail, fax) of examining physician. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
9
1.1 GORD,
ULCERS, IRRITABLE BOWEL
ALIMENTARY SYSTEM
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 RANITIC Rowex block. Transient changes in the results of liver function tests, acute pancreatitis. 2MO H2 blocker. Ranitidine (HCl) 150mg, 300mg. Both: RAZOLAGER Gerard White film-ctd tab. scored one side. 300mg: 2MO Oblong. 150mg-60, A21.73; 300mg-30, A20.56. S Duodenal ulcer, benign gastric ulcer, PPI. Lansoprazole 15mg, 30mg. Opaque, yellow reflux oesophagitis (RO), post operative ulcer, and white gel. caps. resp. 15mg-28, A12.85; 30mgZollinger-Ellison’s syndrome (ZES) and other 28, A23.35. conditions where reduction of gastric acid is likely S Duodenal and gastric ulcer. Reflux to be beneficial. oesophagitis (RO), long-term prophylaxis of RO. P Duodenal and gastric ulcer: 150mg Eradication of H. pylori (Hp) in combination with twice daily or 300mg at bedtime. Duodenal, may antibiotic therapy and prevention of relapse. be increased to 300mg twice daily for up to 4 Zollinger-Ellison syndrome (ZES). NSAID-associated weeks. RO: 150mg twice daily or 300mg at benign gastric and duodenal ulcers (maintenance bedtime for 8 or if necessary up to 12 weeks; and treatment). GORD. moderate to severe oesophagitis, increase to P Ulcers and RO: 30mg once daily 150mg 4 times daily or 300mg twice daily. ZES, see swallowed whole with liquid into empty stomach; SPC. duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 Q Peptic ulcer, 2mg/kg or 4mg/kg twice weeks; double duration if not fully healed. NSAIDdaily; max. 300mg daily. associated ulcers: 30mg once daily for 4 or 8 2K weeks; longer course or higher dose may be used ALSO RANITIC 75MG Ranitidine (HCl) 75mg. Film- if severe or in at risk patients. Prophylaxis of RO and NSAID-associated ulcers: 15mg once daily; may ctd tab. 7, A2.85; 14, A4.76; 28, A8.56. be increased up to 30mg daily. Eradication of Hp: S Short term symptomatic relief of acid indigestion and heartburn. 30mg twice daily in combination with P 1 swallowed whole with water. Repeat recommended antibiotics. ZES: Initially 60mg once if symptoms return. Max. 2 tabs. in 24 hrs. If daily. Individually adjust and continue as long as symptoms persist more than 2 weeks consult necessary. Max. 180mg, if daily dose q 120mg doctor. admin. in 2 divided doses. GORD: 15-30mg once Q Under 16 years, not recommended. daily for up to 4 weeks. If symptoms persist after 4 B Exclude malignant disease before weeks on 30mg further examination treatment. History of acute porphyria. GI ulcers, recommended. Impaired renal function/ mildly severe renal/hepatic impairment, dyspepsia related impaired hepatic function: Max. 30mg daily. weight loss, middle aged or older patients with Moderately impaired hepatic function: Max. 15mg dyspepsia symptoms, patients under regular daily. medical control or taking medication; consult R 15-30mg. Max. 30mg daily. doctor before use. Contains lactose. Pregnancy, Q Not recommended. lactation. D Severely impaired hepatic function. C High doses of sucralfate (take 2 hrs Pregnancy, lactation (no data). apart). NSAIDs (monitor, especially elderly or if B Exclude possibility of malignant gastric history of peptic ulcer). tumour. Caution: Hepatic dysfunction. Risk of GI infections. Treatment q 1 year: Review regularly, RANOPINE Pinewood if visual disturbances occur consult ophthalmologist. Contains sucrose. 2MO C Avoid: Ketoconazole, itraconazole. H2 blocker. Ranitidine (HCl) 150mg white to offwhite round film-ctd tab. marked RAN 150; 300mg Caution: CYP2C19 and CYP3A4 inhibitors and substrates (e.g. theophylline, carbamazepine). white to off-white cap. shaped film-ctd tab. Digoxin, tacrolimus, phenytoin, warfarin. Antacids marked RAN 300. 150mg-60, A19.50; 300mg-30, and sucralfate (take 1 hr apart). A18.48. A GI disorders, eczema, urticaria, itching, S Benign gastric and duodenal ulcers. headache, dizziness, fatigue. Post-operative ulcer. Zollinger-Ellison syndrome, 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.
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
10
gastric and duodenal ulcers (treatment and maintenance), in combination with appropriate antibacterial therapeutic regimens to eradicate H. pylori in patients with H. pylori associated peptic ulcers. Children q1 year and q10kg: Reflux Oesophagitis, symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease. Children over 4 years: In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori. P Duodenal ulcers: 20mg daily for 2-4 weeks; maintenance, 10mg. Benign gastric ulcers: 20mg once daily for 4-8 weeks. RO: 20mg daily for 4-8 weeks. 40mg may be used in refractory RO. Maintenance: 10-20mg. ZES: Initially 60mg daily. Divide doses q80mg in twice daily doses. NSAIDrelated ulcers: 20mg daily for 4-8 weeks. Maintenance: 20mg. GORD: 10-20mg daily for 2-4 weeks; if no improvement after 2 weeks, perform further examinations. H. pylori eradication: 20mg for 1 week in combination with amoxicillin 1000mg + clarithromycin 500mg twice daily; alternatively, in combination with clarithromycin 250mg + metronidazole 400-500mg twice daily. Impaired hepatic function: 20mg daily max. Q See SPC. B Peptic ulcer disease: Determine H. pylori status if relevant. Exclude malignancy before treatment. Confirm RO diagnosis endoscopically. May lead to slightly increased risk of GI infections. Hepatic impairment, check liver enzymes periodically. NSAID-related ulcers: Restrict treatment to at risk patients; consider stopping NSAID. Long term use q 1year: Review risk/ benefit assessment. Combination treatment, caution in patients with renal/hepatic dysfunction. Monitor visual and auditory senses in severely ill patients. Pregnancy, lactation. Contains lactose. C Contra: Atazanavir, St John’s wort. Caution: CYP2C substrates (e.g. diazepam, triazolam, flurazepam, phenytoin, warfarin, hexabarbital, citalopram imipramine, clomipramine), disulfiram, ciclosporin (monitor plasma levels), clarithromycin, ketoconazole, itraconazole, digoxin, vitamin B12. A Somnolence, sleep disturbances (insomnia), vertigo, headaches, drowsiness, GI disorders.
SPASMONAL FORTE
Norgine
2MO Antispasmodic. Alverine citrate 120mg. Grey/blue cap. marked SP120. 60, A15.41. S Irritable bowel syndrome. Painful diverticular disease of the colon. P One, 1-3 times daily. Q Not recommended.
2MO
ALSO SPASMONAL Alverine citrate 60mg blue/ grey cap. marked SP60. 100, A12.84. P 1-2 one to three times daily. ROMEP Rowex Q Under 8 years, not recommended; 8-12 years, 1 three times daily. 2MO PPI. Omeprazole 10mg, 20mg, 40mg. Hard gastro- D Paralytic ileus. Intestinal obstruction, faecal impact, total atony of colon. Pregnancy, resistant cap. containing dull yellowish brown granules.10mg: light brown marked OME10. 20mg: lactation. 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
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 containing white or almost white granules. 7, A6.35; 28, A25.37. S Benign gastric and duodenal ulcer. Reflux Oesophagitis (RO), treatment and maintenance. NSAID related ulcers, treatment, prophylaxis and maintenance. Zollinger Ellison Syndrome (ZES). Hp eradication in peptic ulcer disease. P Duodenal ulcer: 20mg once daily, treatment 2-4 weeks. Gastric ulcer: 20mg once daily, treatment 4-8 weeks. RO, NSAID related ulcers: 20mg once daily, treatment 4-8 weeks; prophylaxis, maintenance 20mg once daily. ZES: Initially, 60mg once daily; divide dose twice daily when above 80mg; no time limit on duration. Hp eradication: 20mg with amoxicillin 1000mg + clarithromycin 500mg or 20mg with clarithromycin 250mg + metronidazole 400-500mg; all twice daily for 1 week. Impaired hepatic function: Max. daily dose, 20mg. Take cap. preferably in the morning before breakfast. Q Above 2 years, refractory RO: 10mg (1020kg) or 20mg (q20kg) once daily. Use alternative product for 10mg dosage. Duration usually 4-8 weeks, max. 12 weeks. Under 2 years, not indicated. B Peptic ulcer disease (determine H. pylori status, exclude possibility of malignancy). Confirm diagnosis of RO endoscopically. Elderly, hepatic/ renal dysfunction (caution, especially in high doses and during combination therapy). Severely impaired hepatic function (check liver enzyme values periodically). NSAID-related ulcers (consider stopping intake of causative agent before treatment). Pregnancy, lactation. C Diazepam (or other benzodiazepines), phenytoin, warfarin, hexobarbital, citalopram, imipramine, clomipramine, disulfiram, cyclosporin, clarithromycin, roxithromycin, erythromycin, ketoconazole, itraconozole, digoxin or vit.B12. A GI disorders, nervous system disorders (drowsiness, somnolence, sleep disturbances, vertigo, headaches).
GORD,
ULCERS, IRRITABLE BOWEL
1.1
lactation. A Headache, dizziness. Rarely hepatitis, thrombocytopenia, leucopenia, hypersensitivity, confusion, breast symptoms.
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; A oval, slightly biconvex tab. 28, 10.82. 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
ALSO ZOLEPANT 40MG Pantoprazole 40mg. Light brownish yellow, oval, slightly biconvex tab. 28, A20.04. 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 + ZANTAC GSK metronidazole 400-500mg twice daily or amoxicillin 1g twice daily + metronidazole 4002MO 500mg twice daily. ZES: Initially 80mg daily. Doses H2 blocker. Ranitidine (HCl) 150mg, 300mg. White q80 mg daily, divide dose and give twice daily. round or capsule-shaped film-ctd tab. marked May be temporarily increased to q160mg (no GXE2 or GXEC3 resp. 150mg-60 (Cal/Pk), A22.42; longer than required for adequate acid control). 300mg-30 (Cal/Pk), A20.68. Impaired renal function: Max 40mg daily. H.pylori 2MO triple therapy not suitable. Severe hepatic impairment: Max 40mg every other day; H.pylori ALSO ZANTAC EFFERVESCENT Ranitidine (HCl) 150mg. White to pale yellow tab. 2 x 15, A18.78. triple therapy not suitable. R Max 40mg daily except for H. pylori 2MO eradication (as per adults for 1 week). ALSO ZANTAC SYRUP Ranitidine (HCl) 150mg/ Q Not recommended. 10ml, ethanol 7.5%. Sugar-free syrup. 300ml, B For prescribing information, see A26.36. pantoprazole Drug Presc. Notes. Contains sorbitol. 2N ALSO ZANTAC INJECTION Ranitidine (HCl) 50mg/ ZOMEL Clonmel 2ml. Amp. 5, A4.38. 2MO S Duodenal, benign gastric and postPPI. Lansoprazole 15mg, 30mg. Opaque, hard operative ulceration. Reflux oesophagitis, gastro-resistant caps.15mg, yellow; 30mg, white. Zollinger-Ellison syndrome, prophylaxis of NSAID associated duodenal ulcer, other conditions where 15mg-28, A10.59; 30mg-28, A19.17. reduction of gastric acid is beneficial. S Healing of confirmed duodenal and P Duodenal and gastric ulcer: 150mg gastric ulcer. Treatment and prophylaxis of reflux twice daily or 300mg at bedtime for four to eight oesophagitis (RO). Treatment and prophylaxis of weeks; maintenance, 150mg at bedtime. NSAID-associated benign gastric and duodenal Prophylaxis of NSAID associated duodenal ulcer: ulcers in patients requiring continued NSAID150mg twice daily. Other conditions, see SPC. treatment. Eradication of H. pylori (Hp) in Q Treatment of peptic ulcer disease 2mg/ combination with antibiotics and prevention of kg or 4mg/kg twice daily; max. 300mg daily. relapse. Zollinger-Ellison Syndrome (ZES). B Exclude malignant disease before Symptomatic gastro-oesophageal reflux disease treatment. Impaired renal function. Pregnancy, (GORD).
ZOTON FASTAB
Wyeth
2MO PPI. Lansoprazole 15mg, 30mg. Oro-dispersible white-yellowish tabs. speckled with orange-dark brown gastro-resistant microgranules debossed with 15 or 30 resp. 15mg-28, A18.26; 30mg-7, A9.08 (hospital only pack); 14, A19.78; 28, A36.29. S Duodenal and gastric ulcer. Treatment and prophylaxis of reflux oesophagitis (RO). Eradication of H. pylori concurrently given with appropriate antibiotics. Treatment and prophylaxis of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued therapy. Symptomatic GORD. Zollinger-Ellison syndrome (ZES). P Duodenal ulcer: 30mg once daily for 2 or 4 weeks. Gastric ulcer/RO: 30mg once daily for 4 or 8 weeks. Prophylaxis of RO: 15-30mg once daily. ZES: 60mg once daily. See SPC. Hp eradication regimens: 30mg twice daily in combination with clarithromycin 250-500mg twice daily and either amoxycillin 1g twice daily or metronidazole 400-500mg twice daily for 7-14 days. NSAID-associated ulcers: Treatment, 15-30mg once daily for 4 or 8 weeks. Prophylaxis, 15-30mg once daily. R Max. 30mg daily. Q Not recommended. B Exclude possibility of malignant gastric tumour. Hepatic dysfunction. Risk of GI infections. Treatment q 1 year: Review regularly. Contains lactose. Driving or using machines. Gastroduodenal 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
11
1.2 CONSTIPATION
ALIMENTARY SYSTEM
ALSO DULCO-LAX LIQUID Sodium picosulph. 5mg/ 5ml. Liquid. 100ml, A2.76; 300ml, A7.78. S Constipation. Bowel clearance before Bulking agent. Methylcellulose 500mg. Pink tab. PPI. Lansoprazole 15mg, 30mg. White/redsurgery, childbirth or radiological examinations. 112, A3.58. brownish and white gel caps., resp. 15mg-28, P 5-10ml at night. A12.96; 30mg-28, A23.31. S Constipation. Patients requiring a high Q Under 4 years, 250mcg/Kg BW; 4fibre diet. 10years, 2.5-5ml. Both at night. S Duodenal and gastric ulcer. Reflux D Ileus, intestinal obstruction, acute oesophagitis (RO), long-term prophylaxis of RO. H. P 3-6 night and morning with at least 300ml liquid. surgical abdominal conditions like acute pylori eradication. Treatment and prophylaxis of Q 6-12 years, half adult dose. appendicitis, acute IBDs, and severe dehydration. NSAID-associated gastric ulcers and duodenal B Pregnancy, adequate fluid intake. B Children under 10 years (medical advice ulcers. Symptomatic gastro-oesophageal reflux required). Pregnancy, lactation (not disease. Zollinger-Ellison syndrome (ZES). CODALAX Mundipharma recommended). P Ulcers and RO: 30mg once daily C Diuretics or adreno-corticosteroids swallowed whole with liquid into empty stomach; 2 M O (increased risk of electrolyte imbalance). Broad duodenal ulcers, 2 weeks; gastric ulcers and RO, 4 Faecal softner/stimulant. Poloxamer ’188’ 200mg, spectrum antibiotics (reduced laxative action). A weeks; double duration if not fully healed. dantron 25mg per 5ml. Liquid. 300ml, 7.23. A Abdominal discomfort (incl. pain and Prophylaxis of RO: 15mg once daily; may be 2MO cramps), diarrhoea. increased up to 30mg daily. Eradication of H. ALSO CODALAX FORTE Poloxamer ’188’ 1g, pylori: 30mg twice daily for 7 days in combination danthron 75mg per 5ml. Liquid. 300ml, A24.17. DUPHALAC Solvay with either clarithromycin 250-500mg twice daily + S Treatment or prophylaxis of analgesic 2O amoxicillin 1g twice daily or clarithromycin 250mg induced constipation in terminally ill. twice daily + metronidazole 400-500mg twice Osmotic. Lactulose 3.35g/5ml. Soln. 300ml, A1.90; P 5-10ml at night. daily. NSAID associated ulcers: 30mg once daily for Q 2.5-5ml at night. 1L, A5.73. 4 weeks, may be continued for another 4 weeks if 2 M O S Constipation. Hepatic encephalopathy. not fully healed. Prophylaxis of NSAID associated P Constipation: Initially 15ml twice daily. ALSO CODALAX CAPSULES Poloxamer ’188’ ulcers: 15mg once daily. If fails, use 30mg once 200mg, danthron 25mg. Light brown/orange cap. Encephalopathy: Initially 30-50ml 3 times daily; daily. Symptomatic gastro-oesophageal reflux: adjust dose to produce 2 or 3 soft stools daily and marked CX. 60, A13.33. 15mg or 30mg once daily; adjust dose individually. P 1-2 at night. an acidic faecal pH. Q Constipation, 1 month-1 year: 2.5ml; 1-2 If symptoms not relieved in 4 weeks, increase to Q 1 at night. years: 2.5-5ml; 2-5 years, 5ml; 5-10 years, 10ml. All 30mg daily. ZES: Initially 60mg once daily. 2MO twice daily. Individually adjust and continue as long as ALSO CODALAX FORTE CAPSULES Poloxamer necessary. Max. 180mg, if daily dose q 120mg ’188’ 500mg, danthron 35.5mg. Light brown/green D Galactosaemia. GI obstruction. B Contains lactose. admin. in 2 divided doses. Impaired renal function/ cap. marked CXF. 60, A14.49. C Avoid enteric coated mesalazine (5mildly impaired hepatic function: Max. 30mg daily. P 1-2 at night. ASA). Moderately impaired hepatic function: Max. 15mg Q Not recommended. A Flatulence. daily. D Intestinal obstruction, acute painful R 15-30mg. Max. 30mg daily. conditions of abdomen. Infants in nappies. FLEET De Witt Q Not recommended. Pregnancy. D Pregnancy, lactation (no data). 2 B Incontinence. B Exclude possibility of malignant gastric A Colouring of urine and perianal skin. Osmotic. Sodium acid phos. 21.4g, Na+ phos. 9.4g. tumour. Caution: Hepatic dysfunction. Risk of GI 133ml single dose enema. 1, 84c. infections. Treatment q 1 year: Review regularly, DULCO-LAX Boehringer Ing. SM S Constipation. Pre- and post-operatively assess benefit against risks; if visual disturbances in obstetrics and prior to proctoscopy, 2K occur consult ophthalmologist. Gastro-duodenal sigmoidoscopy or X-ray. Stimulant. Bisacodyl 5mg. Yellow ent-ctd tab. 10, ulcers, consider H. pylori infection as an etiological A1.21; 20, A2.01; 40, A3.89; 60, A4.64. P 1 enema once daily. factor. Contains sucrose. Driving/using machines. If S Evacuation of colon in constipation and Q Under 3 years not recommended; over 3 used in combination with antibiotics H. pylori years, in proportion according to body weight. in preparation for radiological investigations. eradication, follow antibiotics instructions. Colitis D Conditions where the absorbtive 2K may rarely occur. Restrict treatment to high risk ALSO DULCO-LAX SUPPOSITORIES Bisacodyl 5mg capacity of the colon is increased, CHF. patients for the prevention of peptic ulceration in B Restricted Na+ intake. and 10mg. Suppos. 5mg-5, A1.49; 10mg-10, patients needing continuous NSAIDs. A2.75; 20, A5.10. FYBOGEL CITRUS Reckitt Benckiser C Avoid: Ketoconazole, itraconazole. S Evacuation of colon in constipation and Caution: CYP2C19 and CYP3A4 inhibitors and 2O in preparation for radiological investigations. substrates (e.g. theophylline, carbamazepine). Bulking agent. Ispaghula husk 3.5g. Citrus P Constipation: 1-2 tabs. at night or Digoxin, tacrolimus. Antacids and sucralfate (take flavoured sugar-free and gluten-free grans. 1x10mg suppos. in morning. Diagnostic and 1 hr apart). Sachets-30, A2.48; 60, A4.96. preoperative preparation: 2-4 tabs. night before A GI disorders, increase in liver enzymes 2K and 1x10mg suppos. following morning. levels, urticaria, itching, rash, headache, dizziness, Q Over 10 years, same as adult. 4-10 years: ALSO FYBOGEL ORANGE Ispaghula husk 3.5g. fatigue. Constipation: 1 tab. at night or 1x5mg suppos. in Orange flavoured grans. Sachets-10, A1.97. morning. Diagnostic and preoperative preparation: S Patients requiring a high-fibre regimen. 1.2 CONSTIPATION 1 tab. night before and 1x5mg suppos. following P 1 sachet or 2 level 5ml spoonfuls in morning. Under 4 years, constipation: 1x5mg water morning and evening after meals. BABYLAX Dr. Mann suppos. Q Under 12 years, only on medical advice. 2K 2K 6-12 years, v-1 level 5ml spoonful of the granules, depending on age and size, morning and evening. Faecal softner/lubricant. Glycerol 1.8g, ALSO DULCO-LAX PERLES Sodium picosulfate D Intestinal obstruction, colonic atony. benzalkonium Cl 0.36g. 3.6g soln. in rectal 2.5mg. Small, pearl-shaped, soft gelatin caps. 50, A4.28. applicator. 3, A5.48. KLEAN-PREP Helsinn Birex S Constipation. Bowel clearance before S Constipation in adults, elderly and surgery, childbirth or radiological examinations. children of any age. 2 P 2-4 at night. P 1-2 applicators. Electrolytes/osmotic. PEG 3350 59g, anhydrous sod. Q Over 10 years, as for adults. 4 to10 Q Under 3 months, v-1 applicator; 3 sulph. 5.685g, sod. bicarb. 1.685g, KCl 0.7425g, years, 1-2 at night. Under 4 years, not months-6 years, 1 applicator; over 6 years, 1-2 aspartame 0.0494g, flavouring 0.378g. Sachets-4, recommended. A6.19; 4+container, A6.71. applicators. 2 S GI lavage, preparation prior to B For single use only.
ZOTROLE
Pinewood
12
CELEVAC
Amdipharm
2
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
1.2 CONSTIPATION
ALIMENTARY SYSTEM
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.
P 1-4 as required. Q 15-60mg as required. D Intestinal or urinary obstruction. B Bronchial asthma, cardiac disease, vagotonia, epilepsy, Parkinsonism. C Depolarising muscle relaxants, cyclopropane, halothane. A Nausea, salivation, diarrhoea, colic.
ALSO MOVICOL PAEDIATRIC PLAIN Macrogol 3350 (polyethylene glycol 3350) 6.563g, NaCl 175.4mg, NaHCO3 89.3mg, KCl 25.1mg (on reconstitution: Na+ 65mmol/l, Cl- 53mmol/l, K+ 5.4mmol/l, HCO3- 17mmol/l). Powder. Sachets: 30, A7.14. S Chronic constipation. Faecal impaction. Prevention of recurrence of faecal impaction. 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. LAXIDO ORANGE Galen P 1-2 enemas inserted to full length of Movicol. Reconstitute each sachet in 62.5ml (approx. t glassful) water. 2MO nozzle. Q Under 3 years, not recommended. Over D GI obstruction or perforation, ileus, Laxative. Macrogol 3350 13.125g, NaCl 350.7mg, severe inflammatory condition of intestinal tract NaHCO3 178.5mg, KCl 46.6mg. Free flowing white 3 years, same as adults, insert nozzle to half (eg. Crohn’s disease, UC, toxic megacolon). length only. powder for oral solution in a single-dose sachet. B Monitor for symptoms indicating shifts D Inflammatory or ulcerative bowel 30, A7.68. of fluid/electrolytes. Children with cardiovascular disease, acute GI conditions. S Chronic constipation. Also effective in or renal impairment; not recommended. resolving faecal impaction. MICROLAX McNeil Healthcare Pregnancy, lactation (only if essential). P Chronic constipation: Dissolve each A Abdominal distension, nausea. sachet in 125ml water. 1-3 sachets daily in divided 2 K doses, according to individual response. Can be Faecal softener/lubricant. Sodium citrate 450mg, MOVIPREP Norgine adjusted down to 1 or 2 sachets daily for Na+ lauryl sulphoacetate 45mg, sorbic acid 5mg 2N extended use. Faecal impaction: 8 sachets daily per 5ml. Disposable enema. 50, A27.21. within a 6 hour period. Dissolve each sachet as Laxative. Sachet A: Macrogol 3350 100g, sodium S Constipation, evacuation of the colon above or dissolve 8 sachets in 1 litre of water prior to surgical and diagnostic procedures and in sulphate anhydrous 7.5g, NaCl 2.691g, KCl 1.015g. o o (store reconstituted solution covered at 2 C-8 C for obstetrics prior to delivery. Sachet B: Ascorbic acid 4.7g, sodium ascorbate up to 6 hours). Do not exceed 3 days. Impaired 5.9g. Free flowing powder. Sachet A: White to P 1 enema as required cardiovascular function, no more than 2 sachets to Q Under 3 years, insert half nozzle only; yellow. Sachet B: White to light brown. 4 sachets be taken in any 1 hour. (2 x sachet A and B), A13.26. over 3 years, same as adult. Q Under 12 years, not recommended. Over B IBD. Acute GI conditions. S Bowel cleansing prior to bowel 12 years, as per adults. endoscopy or radiology. D Intestinal obstruction or perforation MIL-PAR Seven Seas P One sachet A and one sachet B caused by functional or structural disorder of the dissolved together in 1L of water to be drunk over 2 gut wall, ileus and in patients with severe period of 1-2 hrs the evening before day of Osmotic/faecal softner. Magnesium hydroxide inflammatory conditions of the intestinal tract. procedure. Repeat with a second litre of product, Pregnancy and lactation (unless clearly necessary). 300mg, liquid paraffin 1.25ml per 5ml. Oral susp. either the evening before or the morning of day 200ml, A2.73; 500ml, A4.20. B Confirm faecal impaction diagnosis by of procedure, at least 1hr before procedure. S Temporary relief of occasional appropriate physical or radiological examination Q Under 18 years, not recommended. constipation. of the rectum and abdomen. Stop immediately if D GI obstruction or perforation, disorders P 15-30mls before breakfast or at symptoms indicating shifts of fluids/electrolytes of gastric emptying (e.g. gastroparesis), ileus, toxic bedtime. develop (e.g. oedema, shortness of breath, Q 2-7 years: 5-10ml; over 7 years: 7.5-15ml. megacolon complicating inflammatory conditions increasing fatigue, dehydration, cardiac failure); of the intestinal tract eg. Crohn’s disease and Taken at bedtime. measure electrolytes and treat any abnormality ulcerative colitis, unconsciousness. D Children Q 2 years old. appropriately. Contains glucose and sulphur B Caution: Swallowing difficulties. Not for B Diarrhoea expected outcome. Caution: dioxide. Fragile, poor health, serious clinical impairment use if symptoms of appendicitis, intestinal C No other medicines to be taken orally (cardiac impairment NYHA grade III), obstruction, IBD, abdominal pain of unknown for 1 hour before and for 1 hour after admin. dehydratation (correct before use), severe acute origin. Contains Mg++ salts. Consult doctor if A Abdominal distension and pain, inflammatory disease. Impaired consciousness, needed every day, persistent abdominal pain/ borborygmi, nausea, mild diarrhoea. impaired gag reflex, tendency to aspiration of symptoms. Consult doctor before use if taking regurgitation: Closely monitor, especially if LAXOSE Pinewood medication, suffer from kidney disease or under nasogastric admin. Poor health, ccQ30ml/min, risk doctor’s care. Prolonged use. 2O of electrolyte imbalance: Baseline and postA Osmotic. Lactulose 3.3g/5ml. 300ml, 1.87; 500ml, MOVICOL Norgine treatment electrolyte renal function test needed. A3.87; 1L, A5.70. Pregnancy, lactation (only if essential). 2MO S Constipation. Hepatic encephalopathy. Iso-osmotic laxative. Macrogol 3350 (polyethylene C Do not take oral medication, P Constipation: initially 15ml twice daily. particularly narrow therapeutic index or short glycol 3350) 13.125g, NaCl 350.7mg, NaHCO Encephalopathy: initially 30-50ml three times daily 178.5mg, KCl 46.6mg (on reconstitution: Na+3 half-life drugs, within one hour of admin. adjusting to produce 2 to 3 soft stools daily. A Nausea, vomiting, bloating, abdominal 65mmol/l, Cl- 53mmol/l, K+ 5.4mmol/l, HCO Q Constipation, 2-5 years, 5ml; 6-10 years, 17mmol/l. Powder. Sachets: 20, A7.63; 30, 3A10.64. pain, anal irritation, sleep disturbance, allergic 10ml. Both twice daily. reaction, hunger, hypophosphatemia, dizziness, S Chronic constipation. Faecal impaction. D Galactosaemia. GI obstruction. headache, rigors. 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 NORMACOL Norgine 2MO cardiovascular function: No more than 2 sachets in 2 O Anticholinesterase. Pyridostigmine bromide 60mg. any one hour. Reconstitute each sachet in 125ml Bulking agent. Sterculia 62%. White coated grans. water. White quarter-scored tab. marked ICN. 200, Sachets-60 x 7g, A5.52; 500g, A6.57. A53.85. Q Under 12 years, not recommended. S Constipation (incl. pregnancy and 2MO lactation). Management of colostomies and S Paralytic ileus.
14
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 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.
DIARRHOEA 1.3 Contains phenylalanine, sunset yellow. A Temporary increase in flatulence and abdominal distension.
2O
Electrolytes. Sodium chlor. 0.47g, K+ chlor. 0.30g, disodium hydrogen citrate 0.53g, glucose 3.56g. Powder in sachet (plain, flavoured). 20, A4.68. RELISTOR Wyeth S Oral correction of fluid and electrolyte loss and management of watery diarrhoea. 2O 2 P 20-40ml/kg daily. (Approx. 1-2 sachets Peripheral opioid receptor antagonist. ALSO NORMACOL PLUS Sterculia 62%, frangula Methylnaltrexone bromide 12mg/0.6ml (20mg/ml). after every loose motion). Reconstitute 1 sachet with 200ml fresh drinking water. 8%. Brown coated grans. 200g, A4.53; 500g, Sterile, clear, colourless to pale-yellow sln for inj. A9.32. Q Children: As per adults except in vial. 0.6ml-1; 0.6ml-7. Prices on request. reconstitute 1 sachet after every loose motion. S Constipation. Initiation and S Opioid-induced constipation in Infants: 1 to 1v times the usual feed vol or 150ml/ maintenance of bowel action after rectal surgery advanced illness patients receiving palliative care kg daily. Infants under 12 months: Only under or haemorrhoidectomy. when response to usual laxative therapy not medical advice. P 1-2 heaped 5ml spoonfuls once or twice sufficient. B Only reconstitute with water at volume daily after meals swallowed unchewed with a P 1 single dose every other day as a stated. Severe renal/hepatic impairment or other drink. subcutaneous inj. May be given at longer conditions where normal electrolyte balance is Q Under 6 years, not recommended; 6-12 intervals, if needed. 2 consecutive doses 24 hrs years, in proportion to adult dose. apart may be given only when there has been no distributed. If nausea and vomiting present, drink small but frequent amounts at first. If no response to the dose on the preceding day. PICOLAX Ferring Recommended dose: 8mg (0.4ml) (patients improvement within 24-36 hr consult physician. weighing 38-61kg) or 12mg (0.6ml) (patients 2 ELECTROLADE Eastern weighing 62-114kg). See SPC. Stimulant/osmotic laxative. Na+ picosulph. 10mg, Q Not recommended. 2 magnesium oxide 3.5g, citric acid 12.0g. Powder. D Known or suspected mechanical Sachets-1 x 2, A6.29. Electrolytes. Sodium chlor. 236mg, K+ chlor. gastrointestinal obstruction or acute surgical S Bowel clearance before radiography, 300mg, Na+ bicarb. 500mg, glucose 4g. Powder abdomen. Pregnancy (unless clearly necessary). endoscopy or surgical procedures. (flavoured) in sachets. 6, A1.39; 20, A4.43. B Not recommended: Severe hepatic P 1 sachet reconstituted in water and S Dehydration associated with diarrhoea. impairment or end-stage renal impairment taken before 8h00 on day prior to procedure, P 1-2 sachets after every loose motion, requiring dialysis. Not indicated for non-opioid repeat 6-8 hours later. max. 16 in 24 hours. Reconstitute 1 sachet in induced constipation. Can result in the rapid onset 200ml water. Q Not recommended. of a bowel movement (within 30-60 min). Use only Q Under 2 years, 1-1v times normal feed D CHF, gastric retention, GI ulceration, for a limited period. Caution: Patients with toxic colitis/megacolon, ileus, nausea and volume; over 2 years, 1 sachet after every loose colostomy, peritoneal catheter, active diverticular vomiting, acute surgical abdominal conditions, GI motion, max. 12 in 24 hours. obstruction/perforation. Severe renal impairment. disease or faecal impaction (no data). Lactation. D Renal impairment. Impaired consciousness, general weakness. Patients A Dizziness, GI disturbances, injection site reactions. IMODIUM McNeil Healthcare with a tendency to aspiration or regurgitation or impaired swallowing reflex. 2MO SENOKOT Reckitt Benckiser B Recent GI surgery. Caution: Renal Opiate. Loperamide (HCl) 2mg. Dark green/grey 2 impairment, heart disease or IBD. Patients at risk cap. 60, A5.11. of hypokalaemia. Monitor for signs of Stimulant laxative. Sennoside B (as total S As an adjunct in the management of hyponatraemia (correct promptly). Elderly, sennosides) 7.5mg. Brown tab. marked with tab diarrhoea. debilitated patients and at risk patients (those name and a sword. 20, A2.62; 60, A5.46; 100, P Adults and children 9-12 years, 2-4mg A7.26; 500, A18.77. with increased risk for underlying renal initial dose, followed by 2mg 3 times daily. Max. impairment, electrolyte disturbance, acute MI, 2 daily dose 10mg. unstable angina); maintain adequate hydration Q 4-8 years, total max. 4mg.Under 4 years, ALSO SENOKOT SYRUP Sennoside B (as total and monitor baseline and post treatment not recommended. sennosides) 15mg/10ml. 150ml, A5.19. electrolytes. Advise low residue diet before and S Occasional constipation. 2MO 250ml/hour water/other clear fluid intake during P 2-4 tabs. or 10-20ml syrup at bedtime. If ALSO IMODIUM ORAL SOLUTION Loperamide treatment. Use for 24 hour max. Pregnancy, no bowel action after 3 days, consult doctor. (HCl) 1mg/5ml. Slightly viscous soln. 100ml, A2.21. caution. Q Under 12 years, not to be given except S Adjunct in the management of C Absorption of concomitant oral on medical advice. If admin. to children necessary: diarrhoea. Symptomatic control of diarrhoea medication may be modified. Bulk-forming 2-6 years, 2.5-5ml syrup in 24 hrs; over 6 years, associated with chronic bowel disorders. laxatives. Caution: Drugs associated with half adult dose. Both in the morning. Under 2 P 2-4mg (10-20ml) initially followed by hypokalaemia, NSAIDS or drugs known to induce years, not recommended. 2mg (10ml) three times daily. Max. daily dose SIADH (e.g. TCAs, SSRIs, antipsychotics, D Undiagnosed acute or persistent 10mg. Chronic bowel disorders. initially 4-8mg carbamazepine). abdominal symptoms. daily in two divided doses and adjust according to response Orion Q Under 4 years, not recommended; 4-8 REGULAN P & GP TOILAX years, max. daily dose of 4mg in divided doses; 92 2O 12 years, as adult dose. Bisacodyl 10mg/5ml. 5, A3.73; 50, A29.76. Bulking agent. Ispaghula husk 3.4g flavoured, D Use in children under 4 years or when S Constipation, evacuation of colon. sugar-, gluten-free powder or 3.6g flavoured, A P Constipation: 1-2 tabs. in the evening or inhibition or peristalsis is to be avoided. sugar-, gluten-free powder. Sachets. 30, 2.16. B Severe acute UC. Pregnancy. Defective 1 enema. Surgical preparation: 4 tabs. in two S Constipation. To increase daily fiber hepatic function. divided doses on the day prior to examination. intake. A Rashes. Use enema on morning of examination. P 1 sachet in water one to three times Q Constipation: Over 2years, 1-2 tabs. daily. McNeil Healthcare (0.3mg/kg body weight) or 1 enema; under 2years, IMODIUM PLUS Q 6-12 years, v-1 level teaspoonful in 2K v enema. Children insert half nozzle only. water one to three times daily. Over 12 years, as D Inflammatory or ulcerative conditions of Antipropulsive antidiarrheals. Loperamide (HCl) per adults. 2mg, simeticone equiv. to polydimethylsiloxane D Intestinal obstruction, faecal impaction, large bowel. 125mg. White, capsule-shaped tab. 12, A6.05. colonic atony . 1.3 DIARRHOEA B Supervise treatment in the elderly or S Acute diarrhoea associated with gasdebilitated and patients with intestinal narrowing related abdominal discomfort incl. bloating, DIORALYTE sanofi-aventis cramping or flatulence. or decreased motility (GI obstruction risk). AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
15
1.4 ANO-RECTAL
CONDITIONS, COLITIS
ALIMENTARY SYSTEM
P 2 tabs. initially, followed by 1 tab. after every loose stool. Max R 4 tabs. in 1 day. Duration R 2 days. Q 12-18 years: 1 tab. initially, followed by 1 tab. after every loose stool. Max R 4 tabs. in 1 day. Duration R 2 days. Under 12 years, contraindicated. D Children Q 12 years. Acute dysentery, acute UC, pseudomembranous colitis associated with broad spectrum antibiotics. Bacterial enterocolitis caused by invasive organisms. When inhibition of peristalsis is to be avoided due to risk of significant sequelae incl. ileus, megacolon, toxic megacolon. Discontinue if constipation, subileus, abdominal distension develop. Pregnancy (unless clinically justified), lactation. B Fluid and electrolyte depletion may occur. No improvement within 48 hours, discontinue and consult physician. AIDS patients, stop therapy at sign of abdominal distension. Toxic megacolon in AIDS patients with infectious colitis treated with loperamide HCI has been reported rarely. Hepatic insufficiency (caution); hepatic dysfunction (monitor); severe hepatic dysfunction (use under medical supervision). Driving using machines, if dizziness occurs. A Nausea, taste perversion.
Peru balsam 1.8%, benzyl benzoate 1.2%, bismuth oxide 0.87%, resorcinol 0.87%. Cream. 30g, A7.17.
LOMOTIL
2K
Goldshield
2MO Opiate/anticholinergic. Diphenoxylate (HCl) 2.5mg, atropine sulph. 25mcg. White tab. marked SEARLE. 100, A11.52; 500, A57.56, 1000, A115.09. S Diarrhoea. P 4 initially then 2 every six hours until control. Q Under 4 years, not recommended; 4-8 years, 1 three times daily; 9-12years, 1 four times daily; 13-16years, 2 three times daily. D Intestinal obstruction. Acute ulcerative colitis. Pseudo-membranous colitis. Jaundice. B Hepatic dysfunction. Concurrent admin. of narcotics or sedatives. Pregnancy, lactation. Correct severe dehydration and electrolyte imbalance before initiating therapy. C CNS depressants. MAOIs. A CNS disturbances, allergic reactions, gastrointestinal upset. Anticholinergic effects.
0NO ALSO ANUGESIC-HC SUPPS Pramoxine (HCl) 27mg, hydrocortisone (acetate) 5mg, bismuth subgallate 59mg, zinc oxide 296mg, Peru balsam 49mg, benzyl benzoate 33mg, bismuth oxide 24mg. Buff coloured suppository. 12, A3.05. S Severe and acute discomfort or pain associated with internal and external haemorrhoids, proctitis, cryptitis, anal fissures, pruritus ani and perianal sinuses. Also indicated post-operatively in ano-rectal surgical procedures. P 1 suppos. or application of cream night and morning and after defaecation. Q Not recommended. D Tuberculous, fungal and viral infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects. Transient burning on application.
maintenance, 1.2-2.4g daily in divided doses. Crohn’s disease: Maintenance of remission, 2.4g daily in divided doses. Q Not recommended.
2MO
ALSO ASACOLON SUPPS Mesalazine 500mg 20, A14.42. S Proctitis and proctosigmoiditis. Adjunct to oral therapy in severe generalised ulcerative colitis affecting the rectum and rectosigmoid colon. P 1 inserted up to three times daily after defecation depending on the severity of the disease and reducing dose as condition improves. In severe cases insert 1 morning and evening as an adjunct to oral therapy. Q Not recommended. D Hypersensitivity to salicylates. Severe renal impairment. Lactation. B GI tract obstruction. Renal impairment and raised blood urea or proteinuria. Elderly. ANUSOL McNeil Healthcare Pregnancy. C Lactulose. Products that decrease stool 2 Soothing/antiseptic/astringent. Bismuth subgallate pH. A Gl disturbances, headache, blood 59mg, bismuth oxide 24mg, Peru balsam 49mg, dyscrasias, hepatic and renal reactions, zinc oxide 296mg/2.8g. Suppos. 12, A3.62; 24, pancreatitis. A6.29. ALSO ANUSOL CREAM Zinc oxide 10.75%, bismuth oxide 2.14%, Peru balsam 1.8%. Cream. 23g, A3.50.
BUDENOFALK
Dr Falk
0NO
Glucocorticoid. Budesonide 3mg. Hard, pink, gastro-resistant cap. 100, A93.50. S Induction of remission in patients with ALSO ANUSOL OINTMENT Zinc oxide 10.75%, bismuth oxide 0.87%, Peru balsam 1.87%, bismuth mild to moderate active Crohn’s disease affecting the ileum and/or the ascending colon. A subgallate 2.25%. Oint. 25g, 3.50. Symptomatic relief of chronic diarrhoea due to S Haemorrhoids, pruritus ani- and other collagenous colitis. ano-rectal conditions. P 1 cap. 3 times daily about half an hour P 1 suppos. or application of cream or before meals, swallowed with plenty of fluid. oint. night and morning and after defaecation. Max. duration: 8 weeks. Q Not recommended. Q Not recommended (insufficient ANUSOL HC McNeil Healthcare experience). D Hepatic cirrhosis with signs of portal 0N hypertension. Pregnancy, lactation. Steroid/antiseptic/astringent. Hydrocortisone B Increased susceptibility to infections. (acetate) 10mg, benzyl benzoate 33mg, bismuth Caution: Tuberculosis, hypertension, diabetes subgallate 59mg, bismuth oxide 24mg, resorcinol mellitus, osteoporosis, peptic ulcer, glaucoma, 24mg, Peru balsam 49mg, zinc oxide 29mg. cataracts, family history of diabetes or of Suppos. 12, A4.06. glaucoma, exposure to chickenpox or measles, live 0NO QUESTRAN BMS vaccines, severe liver dysfunction. Withdraw ALSO ANUSOL HC OINTMENT Hydrocortisone 2MO (acetate) 0.25%, benzyl benzoate 1.25%, bismuth gradually. Ion-exchange resin. Cholestyramine 4g. Powder in subgallate 2.25%, bismuth oxide 0.87%, resorcinol C CYP3A4 inhibitors. Caution: CYP3A4 inductors or substrates, steroid-binding resins and sachet. 50, A24.32. 0.87%, Peru balsam 1.87%, zinc oxide 10.75%. antacids (take 2 hours apart), cardiac glycosides, S Relief of diarrhoea associated with ileal 15g, A5.10. resection, Crohn’s disease, radiation, vagotomy S Haemorrhoids and inflammation of ano- saluretics. A Depression, irritability, euphoria, and diabetic vagal neuropathy. Pruritus associated rectal area. glaucoma, cataract, hypertension, thrombosis, with partial biliary obstruction. P 1 suppos. or application of oint. night vasculitis, duodenal ulcer, pancreatitis, skin P Diarrhoea, 12-24g daily in divided doses; and morning and after defaecation. disorders, systemic steroid effects, increased risk max. 36g daily. Pruritus, 4-8g daily. Q Not recommended. infections, metabolism and nutrition disorders. Q Under 6 years, not recommended; over D Tuberculous, fungal and viral infections. 6 years, in proportion to dose for 70kg adult. B Avoid prolonged use. Pregnancy. COLIFOAM Meda D Complete biliary obstruction. A Systemic corticosteroid effects. 0NO B On long term, suppl. diet with vitamins Tillotts Steroid. Hydrocortisone acetate 10%. A, D and K. Pregnancy, lactation. Contain sucrose. ASACOLON C Digitalis, antibiotics, diuretics. Take all Mucoadherent foam in aerosol. 20g (approx. 14 2MO drugs 1 hour before or 4-6 hours after Questran. applications) plus applicator, A8.44. Salicylate. Mesalazine 400mg, 800mg. Red-brown A Constipation. A S Ulcerative colitis, proctosigmoiditis, resin-coated oblong tabs. 400mg-100, 27.29; A63.04. granular proctitis. 1.4 ANO-RECTAL CONDITIONS, COLITIS 800mg-90, P 1 applicatorful inserted into the rectum S Treatment of mild acute ulcerative once or twice daily for 2-3 weeks and every colitis. Maintenance of remission of ulcerative ANUGESIC-HC Parke-Davis colitis. Maintenance of surgically-induced remission second day thereafter. 0NO Q Not recommended. of Crohn’s disease. Soothing/antiseptic/steroid. Pramoxine (HCl) 1%, P UC: Induction of remission, 2.4g daily in D Obstruction, abscess, perforation, hydrocortisone (acetate) 0.5%, zinc oxide 12.33%, divided doses increasing to 4g if required; peritonitis, fresh intestinal anastomoses and
16
2K
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,
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. DIPENTUM UCB C Increased antibody formation and Humira clearance when admin. without 2MO methotrexate. Live vaccines, anakinra (not Salicylate. Olsalazine Na+ 500mg yellow scored tab. 250mg beige cap. 500mg-60, A33.25; 250mg- recommended), immunosupressants (caution). A Inj. site reaction, upper and lower 112, A31.04. respiratory infections, viral/bacterial infections, S Treatment of mild-moderate acute candidiasis, dizziness, headache, neurological ulcerative colitis and maintenance of remission. sensation disorders. Cough, nasopharyngeal pain, P Initially 1g daily I divided doses diarrhoea, abdominal pain, stomatitis and mouth increasing to max. 3g daily, maintenance dose ulceration, nausea, hepatic enzymes increased, 500mg twice daily. Must be taken with food. rash, pruritus, dermatitis, eczema, hair loss, Q Not recommended. musculoskeletal pain, pyrexia, fatigue. D Hypersensitivity to salicylates, severe renal impairment. Pregnancy. MEZAVANT XL Shire A GI upset, headache, arthralgia, rash. extensive fistulae. Tuberculous, fungal or viral infections. B Severe ulcerative disease. Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
ENTOCORT CR
2MO
AstraZeneca Salicylate. Mesalazine 1200mg. Red-brown,
ellipsoidal, film-ctd, gastro-resistant prolonged release tab, debossed with S476 on one side. 60, A71.47. S Induction and maintenance of clinical and endoscopic remission of mild to moderate, active ulcerative colitis. P Induction of remission: 2.4 to 4.8g once daily with food. 4.8g/day recommended for patients not responding to lower doses (evaluate treatment after 8 weeks). Maintenance: 2.4g/day. Q Under 18 years, not recommended. D Severe renal impairment (GFR Q30ml/ min/1.73m2) and/or severe hepatic impairment. B Serious blood dyscrasias may occur; discontinue and perform haematological investigations. Risk of hypersensitivity reactions: Conditions predisposing to myo- or pericarditis, chronic lung function impairment (especially asthma). Caution: Mild to moderate renal impairment, hepatic impairment, allergy to sulphasalazine. Renal impairment may occur. Pregnancy (caution at high doses), lactation (if benefit outweighs risk). HUMIRA Abbott C Caution: Known nephrotoxic agents (incl. NSAIDs and azathioprine), thiopurine 2NT methyltransferase, coumarin-type anticoagulants Tumour necrosis factor (TNF) antagonist. e.g. warfarin (closely monitor). Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled A Headache, flatulence, nausea. pen or pre-filled syringe (2 per pack). Price available on request. PENTASA RANGE Ferring S Severe, active Crohn’s disease in patients 2MO who have not responded despite full and PENTASA RECTAL SUSPENSION. Salicylate. adequate course of therapy with corticosteroid A and/or immunosuppressants; or who are intolerant Mesalazine 1g. Enema. 7 x 100ml, 24.79. S Management of active ulcerative colitis. to or have medical contraindications for such P 1 at bedtime for 2-3 weeks. therapies. Induction treatment, admin. in combination with corticosteroids; if corticosteroids Q Under 2 years, contraindicated. Over 2 years, reduced dose according to body weight. inappropriate then admin. as monotherapy. 2MO P 80mg at week 0, followed by 40mg at ALSO PENTASA SUPPOSITORIES Mesalazine 1g. week 2; and then 40mg once fortnightly via SC Suppos. 28, A50.24. injection. If need for more rapid response to S Treatment of ulcerative proctitis. therapy: 160mg at week 0, 80mg at week 2, can P Acute, 1 rectally twice daily for two to be used (higher risk of adverse events during four weeks. Maintenance, 1-2 daily. induction). Q Under 2 years, contraindicated. Over 2 Q Under 18 years, not recommended. years, 20-30mg/kg body weight daily divided into D Active tuberculosis, other severe several doses when possible. infections (sepsis), uncontrolled / opportunistic 2MO infections. Moderate to severe HF. Pregnancy, ALSO PENTASA PR 500MG TABLETS Mesalazine lactation. B Monitor for infections, incl. tuberculosis, 500mg. White grey to pale brown prolongedbefore, during and after treatment; discontinue if release scored tab. marked with tab. strength and PENTASA. 100, A41.13. serious. Do not initiate if active, chronic or localised infection unless controlled. Pre-existing or S Ulcerative colitis and Crohn’s disease.
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/ or the ascending colon. P 3 caps. once daily in the morning, for up to 8 weeks, taken before meals. Q Not recommended. B Caution: Bacterial, fungal or viral infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, family history of diabetes or glaucoma, chicken pox, measles, surgery, liver dysfunction. Withdraw gradually. Pregnancy, lactation. C Cholestryamine, ketoconazole. Avoid grapefruit juice. A Cushingoid features, hypokalaemia, behavioural changes, blurred vision, palpitations, dyspepsia, skin reactions (urticaria, exanthema), muscle cramps, menstrual disorders.
COLITIS
1.4
P Acute treatment (colitis/Crohn’s): Up to 4g daily in 2 or 3 divided doses. Maintenancecolitis: 2g once daily; Maintenance-Crohn’s: Initially 1.5g daily in 2 or 3 divided doses. Q Under 2 years, not recommended. Over 2 years, acute treatment, 20-30mg/kg body weight daily in two or three divided doses.
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/ Tabs: Children Q2 years, active peptic ulcer, coagulopathy, severe liver and/or renal impairment. Sachets: Children Q12 years. B Caution: Hepatic, renal impairment, haemorrhagic diathesis, active peptic ulcer, allergy to sulphasalazine. Monitor: Renal and liver function, differential blood counts. May occur: Renal dysfunction (nephrotoxicity risk increased by concomitant NSAIDs and azathioprine), cardiac hypersensitivity reactions (myo- and pericarditis), blood dyscrasias (perform blood test if suspected). C Caution: Known nephrotoxic agents (incl. NSAIDs and azathioprine), 6-mercaptopurine. A Headache, diarrhoea, abdominal pain, nausea, vomiting, rash.
PERINAL SPRAY
Dermal
2MO Steroid/local anaesthetic. Hydrocortisone 0.2%, lignocaine (HCl) 1%. Soln. in a metered dose pump spray. 30ml, A7.26. S Anal and perianal pain and pruritus such as associated with haemorrhoids. P Spray twice over affected area, up to three times daily. Q Not recommended. D Bacterial, viral or fungal infections. B Avoid prolonged use. Pregnancy. A Systemic corticosteroid effects.
PREDFOAM
Forest
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. D Peritonitis, fistulae, obstruction, perforation, infections. B Avoid prolonged use. Pregnancy.
PREDSOL
UCB
0NO Steroid. Prednisolone (as disodium phos.) 20mg. Enema. 7 x 100ml, A6.09. S Ulcerative colitis. Crohn’s disease. P 1 at night for 2-4weeks. Q Not recommended. D Tuberculosis, bacterial, fungal and viral infections. B Avoid prolonged use. Severe disease.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
17
1.4 ANO-RECTAL
CONDITIONS, COLITIS
ALIMENTARY SYSTEM
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 PREPARATION H Wyeth Healthcare tranquillisers, alcohol, dihydroergotamine, acetylsalicylic acid, NSAIDs. 2 Soothing/antiseptic. Alcohol soluble extract of live A Headache, dizziness, nausea. yeast cells 1%, shark liver oil 3%. Rectal ointment. REMICADE Schering-Plough 25g, A3.64. 2N S Haemorrhoids. P Application of oint. morning and night Monoclonal antibody. Infliximab 100mg. Powder and after defaecation. for conc. for soln. in vial. 1, A690.43. Q Not recommended. S Severe active Crohn’s disease, fistulising Crohn’s disease and moderate/severe active PROCTOFOAM HC Meda ulcerative colitis where conventional therapy (eg. corticosteroids, immunosuppressants, 6-MP or AZA) 0MO is inappropriate or ineffective. Steroid/local anaesthetic. Hydrocortisone acetate P Crohn’s/UC: 5mg/kg IV inf. over 2 hrs, 1%, pramoxine (HCl) 1%. Mucoadherent foam in repeat after 2 and 6 weeks. Repeat inf. every 8 aerosol. 21.2g plus applicator, A5.63. weeks; alternatively re-admin. inf. if symptoms S Haemorrhoids, proctitis, cryptitis, recur. Discontinue use if no response following fissures. initial inf. after 2 doses in severe active and after P 1 applicatorful in the rectum 2 or 3 times daily and after defaecation. Perianally, apply 3 doses in fistulising active and UC. Crohn’s re admin.: Within 16 weeks following last inf. as needed. Q Crohn’s in 6-17 year olds: 5mg/kg IV inf. Q Not recommended. over 2 hrs, repeat after 2 and 6 weeks. Follow D Tuberculous, fungal or viral infections. with inf. every 8 weeks. B Avoid prolonged use. Pregnancy. D TB (must be screened for active/ A Systemic corticosteroid effects. inactive), severe infections eg. sepsis, abscesses. PROCTOSEDYL sanofi-aventis Moderate/severe HF. Women should use adequate contraception and should not breastfeed during 0NO treatment and within 6 months of last dose. Steroid/local anaesthetic/antibiotic. Hydrocortisone B Monitor for acute inf. reactions during/ 5mg, cinchocaine (HCl) 5mg, framycetin sulph. within a few hours of inf. If necessary interrupt 10mg, esculin 10mg. Suppos. 12, A3.44. immediately. Ensure emergency equip. and 0NO treatment available. Monitor patients retreated ALSO PROCTOSEDYL OINTMENT Hydrocortisone after a long period. Caution: Chronic infection or 0.5%, cinchocaine (HCl) 0.5%, framycetin sulph. recurrent infections. Discontinue if patient 1%, esculin 1%. 30g, A7.62. develops symptoms of lupus-like syndrome, antiS Haemorrhoids, anal fissure, nuclear antibodies or serious infection. Elderly, inflammation, pruritus. hepatic impairment, mild heart failure. Increased V 1 suppos. and/or application of oint. risk of malignancies (caution with heavy smokers, morning and night and after defaecation. history of malignancy). UC patients: Regularly D Tuberculous, fungal and viral infections. screen for dysplasia. Crohn’s: Rare cases of B Avoid prolonged use. Pregnancy. hepatosplenic T-cell lymphoma reported. A Systemic corticosteroid effects. Paediatric Crohn’s: If possible, bring up to date with all vaccinations before initiating Remicade RECTOGESIC Clonmel therapy. 2MO C Anakinra, live vaccines (not recommended). Nitrate. Glyceryl trinitrate 4mg/g. Ointment. 30g, A44.02. A Viral infection, serum sickness-like reactions, headache, vertigo, flushing, RTIs, S Relief of pain associated with chronic dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC anal fissure. tissue disorders, fatigue, chest pain, fever, elevated P 375mg (measured using dosing line on hepatic transaminases, inf. reactions. carton) applied intra-anally every 12 hours. Continue until pain abates, up to max. 8 weeks. ROWATANAL Rowa Q Under 18 years, not recommended. D Previous idiosyncratic reactions to other 2 organic nitrates. Postural hypotension, Soothing/antiseptic/astringent. Bismuth subgallate hypotension or uncorrected hypovolaemia; 2%, zinc oxide 8%, menthol 1%. Cream. 26g, increased intracranial pressure or inadequate A3.40. cerebral circulation; migraine or recurrent S Haemorrhoids, anal irritation. headache; aortic or mitral stenosis, hypertrophic P Apply three times daily and after obstructive cardiomyopathy; constrictive defaecation. For internal haemorrhoids use pericarditis or pericardial tamponade; marked cannula nozzle. anaemia or closed-angle glaucoma. Q Not recommended. B Severe hepatic or renal disease. Avoid
Pregnancy, lactation. C Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, aminoglutethimide, hypoglycaemics, antihypertensives, diuretics, coumarin, salicylates. A Systemic corticosteroid effects.
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.
18
SALAZOPYRIN
Pharmacia
2MO Salicylate-sulphonamide. Sulphasalazine 500mg. Orange/yellow round tab. marked kPh on one side
and 101 on the other. 112, A9.41.
2MO ALSO SALAZOPYRIN EN-TABS Sulphasalazine 500mg. Orange/yellow ent-ctd oval tab. marked KPh one side and 102 on reverse. 112, A13.27. S Ulcerative Colitis. Active Crohn’s Disease. P Attack, 2-4 tabs. four times daily in conjunction with steroids. Maintenance, 4 tabs. a day. Q Under 2 years, not recommended. Others: Attack or relapse, 40-60mg/kg body weight daily. Maintenance, 20-30mg/kg daily.
2MO 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
Dr Falk
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. Long term treatment and prevention of 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, 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
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 500mg or 1000mg once daily preferably in the morning; alternatively 1 sachet of Salofalk 500mg or 1000mg 3 times daily (equiv. 1.5-3g daily) as required; usual duration 8-12 weeks. Maintenance: 1 sachet of Salofalk 500mg 3 times daily. Swallow without chewing, with plenty of liquid. Q Under 6 years, not recommended. Over 6 years and adolescents, acute treatment: 3050mg/kg/day once daily preferably in the morning or in 3 divided doses; maintenance: 15-30mg/kg/ day in 2 divided doses. Usually: Up to 40kg, half adult dose; above 40kg, normal adult dose.
2MO 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).
GALLSTONES,
PANCREATIC DISORDERS
1.5
S Dissolution of cholesterol gallstones in functioning gallbladders. Primary biliary cirrhosis (PBC) stages I-III. P Usually 10-12mg/kg daily taken in the ANTOX Pharma Nord evening i.e. usually 750mg daily in the evening. Y Q Not recommended. Oral nutritional. L-Methionine 480mg, vit. C D Radio-opaque calcified gallstones. Non120mg, vit. E 35mg, selenium 50mcg. Yellow oval functioning gallbladder. Pregnancy or women tab. 180, A79.46. who may become pregnant. Inflammation of small S Chronic pancreatitis. intestine or colon, extra hepatic cholestasis, P Up to 6 daily. hepatitis or cirrhosis. Q Under 16 years, at discretion of B LFT’s prior to and during therapy. Not physician. Under 5 years, not recommended. recommended for gallstones above 15mm. diam. D Suspected or proven schizophrenia. or of non-cholesterol origin. Monitor progress Renal insufficiency. Parenteral use. Pregnancy, radiologically. Secondary calcification of lactation. cholesterol stones may occur (related to length of B Use under medical supervision. Not treatment). suitable as sole source of nutrition. C Alum. hydroxide, cholestyramine or colestipol which bind and prevent absorption. CREON 10000 Solvay A Mild transient diarrhoea.
1.5 GALLSTONES, PANCREATIC DISORDERS
2MO Pancreatic enzyme. Pancreatin 150mg equiv. to lipase 10,000, amylase 8,000, protease 600 PhEur units. Brown/clear cap. containing gastro-resistant granules. 100, A19.33.
2MO
2.1 CONGESTIVE HEART FAILURE, TACHYCARDIA, POST-MI
ACCUPRO
Pfizer
2MO
ALSO CREON 25000 Pancreatin 300mg equiv. to lipase 25,000, amylase 18,000, protease 1000 PhEur units. Orange/clear cap. containing gastro-resistant granules. 50, A23.09.
ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. 5mg, 10mg, 20mg: Elliptical, triangular or round resp., brown film-ctd tabs. All marked with tab. strength. 40mg: Reddish-brown, oval biconvex 2MO film-ctd tab. with debossing 40 on one side and PD 535 on reverse. 5mg-28, A8.38; 10mg-28, ALSO CREON 40000 Pancreatin 400mg equiv. to 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 PhEur units. Brown/clear cap. containing gastroresistant granules. 100-A56.92. in congestive heart failure. S Pancreatic exocrine insufficiency. P Initiate treatment under close medical V Initially 1 or 2 with meals. Adjust supervision with 5mg single dose increasing up to according to response. 40mg daily given in one or two doses. Usual 2MO maintenance, 10-20mg daily with concomitant therapy. Treatment of severe or unstable CHF ALSO CREON FOR CHILDREN 5000 Pancreatin SCHERIPROCT Bayer Schering should be initiated in hospital. 60.36mg equiv. lipase 5,000, amylase 3,600, 0MO Q 6-12 years, not recommended. protease 200 PhEur units. Round, light brown Steroid/local anaesthetic. Prednisolone caproate D Subaortic stenosis, history of ACE inh. gastro-resistant granules. 20g, A27.57. equiv. prednisolone 0.15% and cinchocaine (HCl) Q Initially 5000 lipase units with each feed related angioneurotic oedema. Pregnancy, A 0.5%. Oint. 30g, 5.13. or meal. Adjust according to response. Max. daily lactation. S Internal or external haemorrhoids, anal dose: 10,000 lipase units/kg/day. B Hypoglycaemia, neutropenia/ fissures and proctitis. D Hypersensitivity to porcine proteins. agranulocytosis, anaphylactoid reactions. Caution: V Apply twice daily; for faster relief, up to Early stages of acute pancreatitis. Hepatic impairment, alcoholic cyrrhosis. Renal four times on day 1. B Monitor abdominal symptoms insufficiency; monitor renal function before and 0MO (especially if doseq10,000 units lipase/kg/day). during therapy. Contains lactose. ALSO SCHERIPROCT SUPPOSITORIES Prednisolone Pregnancy, lactation (only if clearly necessary). C Avoid tetracyclines. Caution: b-blockers, A GI disorders, skin and SC tissue allergic caproate equiv. prednisolone 1mg, cinchocaine methyldopa, diuretics, lithium, agents increasing or hypersensitivity reactions. (HCl) 1mg. 12, A2.43. serum K+, antidiabetics, surgery/anaesthesia. V 1 once daily; if severe, two to three A Pharyngitis, insomnia, hyperkalaemia, ROWACHOL Rowa times daily on day 1. paraesthesia, dyspnoea, abdominal pains, back D Tuberculous, fungal and viral infections. 2 O pain, myalgia, asthenia. B Avoid prolonged use. Pregnancy. Essential oils. Menthol 32mg, menthone 6mg, ACEOMEL Clonmel A Systemic corticosteroid effects. essential oils a-b-pinenes 17mg, camphene 5mg, cineole 2mg, borneol 5mg. Green ent-ctd oval 2MO ULTRAPROCT Bayer Schering gelatin cap. 50, A4.76. ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. S Hepato-biliary disorders incl. the 0MO White scored tabs. marked with logo one side and dissolution of radiolucent gallstones in the Steroid/local anaesthetic/antihistamine. coded 344, 345 or 346 on reverse. 12.5mg-56, functioning gallbladder. A7.73; 25mg-56, A8.69; 50mg-56, A14.80. Fluocortolone pivalate 0.092%, fluocortolone P 1-2 caps three times daily before meals. S Congestive heart failure when diuretic hexanoate 0.095%, cinchocaine (HCl) 0.5%. Oint. Q 6 to 14 years: 1 cap three times daily 30g, A5.30. (frusemide 40-80mg or equiv.) is insufficient to control symptoms. S Internal or external haemorrhoids, anal before meals. Under 6 years, not recommended. D Pregnancy, lactation. P Initially 6.25mg or 12.5mg. Usual fissures and proctitis. P Apply twice daily; for faster relief, up to B Oral contraceptives. Oral anticoagulants. maintenance 25mg twice daily. Max. 150mg daily. C Oral contraceptives. Oral anticoagulants. Q Not recommended. four times on day 1. D Aortic stenosis. See SPC. D Tuberculous, fungal and viral infections. URSOFALK Dr Falk B Initiate under close supervision. With 1st trimester of pregnancy. 2MO renal impairment, collagen vascular disease, B Avoid prolonged use. Pregnancy, Bile acid. Ursodeoxycholic acid 250mg. White cap. immunosuppressant therapy, monitor white cell lactation. 100, A53.02. count and urinary protein. A Systemic corticosteroid effects. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
19
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
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 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.
A Facial flush, dyspnoea, bronchospasm, thoracic constriction, nausea. Rarely discomfort, sweating, palpitations, hyperventilation, head pressure, apprehension, blurred vision, burning sensation, bradycardia, asystole, chest pain, headache, dizziness.
blockers, digitalis, local anaesthetics, TCAs, disipramine, cyclosporin, digoxin, cimetidine, quinidine, phenobarbital, rifampicin, oral anticoagulants. A Nausea, blurred vision, vertigo, proarrythmic events, GI disorders.
AMOLIN
ATACAND
Ergha
3MO
AstraZeneca
2MO
Cardioselective b-blocker. Atenolol 25mg, 50mg,100mg. White film-ctd tabs. marked C23, C24 and C25 resp. 25mg-30, A2.60; 50mg-30, A3.93; 100mg-30, A5.16. S Cardiac dysrhythmias. Early intervention of myocardial infarction. ADENOCOR sanofi-aventis P 50-100mg daily. 2N Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Purine nucleoside. Adenosine 6mg/2ml of 0.9% Na+ Cl sterile soln. Vial. 6 x 2ml, A31.07. ARYTHMOL Abbott S Supraventricular arrhythmias, tachycardia where there is doubt as to the 2MO diagnosis. Class I antiarrhythmic. Propafenone (HCl) 150mg, P Admin. by rapid IV bolus inj. when 300mg. White film-ctd tabs. 150mg-90, A23.19; facilities exist for cardiac monitoring. Initially 3mg 300mg-60, A23.19. over 2 seconds. If necessary second dose of 6mg S Ventricular and supraventricular should be given if there is no elimination of the extrasystoles and tachycardias, tachyarrhythmias. supraventricular tachycardia within 1-2 mins. A P Adjust to individual requirements. third dose of 12mg may be given. See SPC. Q Not recommended. Q Not recommended. D Manifest HF, sick sinus syndrome, D 2nd or 3rd degree AV block and sick complete heart block, cardiac shock, severe sinus syndrome (except in patients with bradycardia, 3 months post-MI, marked functioning artificial pace maker), asthma. hypotension, electrolyte imbalance, severe B Atrial fibrillation/flutter, prolonged QT obstructive pulmonary disease, myasthenia gravis, interval. known hypersensitivity. C Dipyridamole, xanthines, drugs tending B Initiate under cardiological surveillance. C Other anti-arrhythmic agents, bto impair cardiac conduction. PRESCRIBING NOTES HEART FAILURE (HF) HF is diagnosed in patients with known/suspected cardiac disorder who present with dyspnoea, fatigue, oedema. HF arises from primary myocardial disease, such as dilated cardiomyopathy, but it occurs most frequently secondary to coronary artery disease. Valvular heart disease and arrhythmias, e.g. uncontrolled atrial fibrillation, are other common causes of HF. HF is graded either as mild, moderate or severe or using the New York Heart Association reference grades I, II, III, IV. When investigating HF an echocardiogram is the most useful tool. An ECG is seldom normal but not diagnostically abnormal in impaired hearts while a chest x-ray is not usually helpful in diagnosing the aetiology but may show an enlarged heart and changes in the lung fields. Other investigations should include baseline blood tests, such as full blood count (to 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.
20
CIRCULATORY SYSTEM
Angiotensin II antagonist. Candesartan cilexetil 2mg, 4mg, 8mg, 16mg. White, white, light pink and pink tabs. resp. 4, 8 and 16mg tabs scored. 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; 16mg-28, A24.74. S Treatment of heart failure and impaired left ventricle systolic function as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated. P Initially 4mg once daily. Titration to target dose 32mg once daily done by doubling dose at intervals of min. 2 weeks. 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+ and renal function. Contain lactose. C Caution: K+sparing diuretics, K+suppl., heparin, lithium, antihypertensives, indomethacin. A Hypotension, hyperkalaemia, renal impairment, increases in creatinine, urea and K+.
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 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
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
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 ATENOMEL Clonmel reversible), hepatic insufficiency, neutropenia/ agranulocytosis, cough. 3MO C Not recommended: Lithium. Caution: Cardioselective b-blocker. Atenolol 25mg, 50mg, Diuretics, K+ sparing diuretics, K+ supplements, 100mg. White tab. marked C23, C24, C25. 50 and salt substitutes containing K+, NSAIDs (incl. 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; acetylsalicylic acid r 3g/day), other 100mg-30, A5.01. antihypertensives, certain anaesthetics, tricyclic S Cardiac arrhythmias, early intervention antidepressants and antipsychotic agents, in acute MI. sympathicomimetics, anti-diabetics. P 50-100mg daily. A Dizziness, headache, orthostatic effects Q Not recommended. (incl. hypotension), diarrhoea, vomiting, renal D See 2.4, b-blockers Drug Presc. Notes. dysfunction, impotence.
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, BELLISIN Ranbaxy BELLRAMIL Ranbaxy conjunctivitis, symptomatic hypotension, syncope, 2MO MI or cerebrovascular accident possibly secondary 2 M O ACE inhibitor. Lisinopril (as dihydrate)10mg, 20mg. to severe hypotension, chest pain, palpitations, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 Uncoated tabs debossed with strength on 1 side. rhythm disturbances, angina pectoris, vasculitis, hard cap. with resp. yellow, orange, maroon or Light yellow biconvex cap-shaped tab. (10mg); dry tickling cough, rhinitis, sinusitis, bronchitis, blue cap /white body, imprinted with R on cap light peach biconvex cap-shaped tab. (20mg). bronchospasm, GI disorders, cutaneous and and strength on body. Contain white to off-white 10mg-28, A7.87; 20mg-28, A9.32. mucosal reactions, muscle cramps, muscle and joint S Symptomatic cardiac insufficiency. Short- granular powder. 2.5mg-30, A5.50; 5mg-30, pains, impaired renal function, impotence, A7.10; 10mg-30, A9.60. term treatment (6 weeks) of haemodynamically decreased libido, taste change/reduction/loss, fever stable patients in the 24 hours following acute MI. S To reduce risk of MI, stroke, headache, fatigue, malaise, increases in blood P Heart failure: Initially 2.5mg once a day cardiovascular death or need for revascularisation urea, nitrogen and serum creatinine, decreased procedures in patients of 55 years or more with under medical supervision. Increase to highest serum Na+, increased serum K+. clinical evidence of cardiovascular disease dose tolerated, up to max 35mg once a day by increments of not more than 10mg, at intervals r (previous MI, unstable angina or multivessel CABG BETALOC AstraZeneca or multivessel PTCA), stroke or peripheral vascular 2 weeks. Acute MI: Do not start if systolic BP 3MO disease or with one or more of the following Q100mmHg. Initially (3 days after infarct), 5mg Cardioselective b-blocker. Metoprolol tartrate orally, followed by 5mg after 24 hours, 10mg after clinical findings: Hypertension (systolic 50mg white tab. scored and marked A/BB; 100mg 48 hours and 10mg/day thereafter. Low systolic BP BPq160mmHg or diastolic BPq90mmHg); high white tab. scored and marked A/ME. 50mg-100, (R120mmHg) at start of treatment or within first total cholesterol q5.2mmol/L); low HDL A3.51; 100mg-100, A6.52. (Q0.9mmol/L); current smoker; known 3 days of infarct: Initially, 2.5mg orally. microalbuminuria; clinical evidence of previous S Cardiac arrhythmias. Maintenance, 10mg once a day. Reassess after 6 vascular disease. Congestive HF as adjunctive P 50mg two or three times daily; max. weeks. If hypotension occurs (systolic BP therapy to diuretics with or without glycosides. 300mg daily. R100mmHg), 5mg with temporary decrease to Reduces mortality when given to patients Q Not recommended. 2.5mg if necessary; withdraw if prolonged. Renal surviving acute MI with clinical evidence of HF. 3 N impairment, ccQ10ml/min, initially 2.5mg; ALSO BETALOC INJECTION Metoprolol tartrate 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ P Reducing risk of MI, stroke or cardiovascular death and/or need for min, initially 5-10mg/day. 1mg/ml. 5ml amp. 5, A3.03. revascularisation procedures: Initially, 2.5mg once Q Not recommended. S Maintenance therapy in myocardial daily. Double dose after 1 week, after 3 further D History of angioedema associated with infarction. Supraventricular arrhythmias. weeks increase to 10mg. Maintenance: 10mg once D See 2.4, b-blockers Drug Presc. Notes. prior ACE inhibitor treatment, hereditary or daily. Congestive HF: Patients stabilised on diuretic idiopathic angioedema, pregnancy, lactation. therapy, 1.25mg once daily. If needed, double BIOCARD Niche B Caution: Acute MI (renal dysfunction, dose at 1-2 week intervals. If daily dose q2.5mg do not use), mitral stenosis and LV outflow 3MO required, take as a single dose or as 2 divided obstruction, aortal stenosis, hypertrophic a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, doses. Max daily dose: 10mg. Post MI: Initiate in myocardiopathy, bilateral renal artery stenosis or hospital between day 3 and day 10 following MI. 25mg. Round bevel edged tabs. (3.125mg), scored 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 days interval. If initial 2.5mg not tolerated, 1.25mg scored). All slightly biconvex, white. 3.125mg-28, A5.09; 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 This medicinal product 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. contains substance(s) P Titrate dose individually and monitore Maintenance: 2.5mg-5mg twice daily. Renal prohibited for use in specific impairment: ccQ30ml/min, initially 1.25mg once during up-titration. Initially, 3.125mg twice daily for 2 weeks. If tolerated, titrate at min. 2 week daily, max 5mg once daily; ccQ10ml/min, 1.25mg sports only (as listed in daily, maintenance 2.5mg once a day max. intervals to 6.25mg twice daily, then to 12.5mg WADA Prohibited List 2010). once Hepatic impairment: Initially, 1.25mg under close twice daily, then 25mg twice daily. Max. 25mg Athletes requesting to use medical supervision. twice daily in patients under 85kg, or 50mg twice daily in patients over 85kg. this product in these specific R Caution Q Not recommended. Q Under 18 years, not recommended. sports are required to apply D History of angioneurotic oedema, D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV haemodynamically relevant renal artery stenosis for a TUE. inotropic support, liver dysfunction. (bilateral or unilateral in single kidney). Aortic or 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.
Anti-Doping Information
s
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
21
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
on both sides. 8mg: Round pale pink tab. with single score line on both sides. 16mg: Round light pink tab. with one convex side embossed with 16 Cardioselective b-blocker. Bisoprolol fumarate and one scored flat side. 32mg: Round light pink 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. Round tab. with convex sides, debossed 32 on one side film-ctd tablet encoded BIS and strength on one and scored on the other. 2mg-7, A1.81; 2mg-28, side. White (2.5mg), yellow-white with a score A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, (3.75mg), yellow with a cross score (5mg), yellow 15.81; 16mg-28, A19.22; 32mg-28, A24.63. with a score (7.5mg), apricot with a cross score S Heart failure and left ventricle systolic (10mg). 1.25mg-28, A5.58; 2.5mg-28, A5.17; dysfunction (LVEF R40%) as add-on therapy to 3.75mg-28, A6.38; 5mg-28, A5.34;7.5mg-28, ACE-inhibitors or when ACE-inhibitors not A7.74;10mg-28, A6.01. tolerated. S Stable chronic HF with reduced systolic P Initially 4mg once daily. Titrate up to LV function in addition to ACE inhibitors and 32mg once daily by doubling dose at intervals of diuretics, and optionally cardiac glycosides. at least 2 weeks. P Should be taken with liquid (not Q Safety and efficacy not established. chewed), in the morning. Requires titration, D Pregnancy, lactation. Severe hepatic monitoring vital signs closely, increasing dose if impairment and/or cholestasis. well tolerated: 10mg (max) once daily for B Not recommended: Primary maintenance. If max dose not well tolerated, hyperaldosteronism. Caution: Haemodynamically consider gradual dose reduction. Lower dose or relevant aortic mitral valve stenosis, obstructive consider gradual discontinuation if transient hypertrophic cardiomyopathy, severe CHF, worsening of HF, hypotension, bradycardia occur. underlying renal disease (incl. renal artery Q Not recommended. stenosis), haemodialysis (carefully titrate with D Acute HF or during episodes of HF thorough monitoring of BP), anaesthesia and decompensation requiring IV inotropic therapy. surgery. Monitor renal function, serum K+ and Cardiogenic shock. AV block of 2nd or 3rd degree creatinine levels (HF, elderly, renal impairment, (without a pacemaker). Sick sinus syndrome. concomitant ACE inhibitor). Hypotension may Sinoatrial block. Bradycardia (Q 60 beats/min) occur. Contains lactose. before start of therapy. Hypotension (systolic BP C Possible interaction with NSAIDs. Q 100mmHg). Severe bronchial asthma or severe Antihypertensive effect may be enhanced by other COPD. Late stages of peripheral arterial occlusive antihypertensives. K+ -sparing diuretics, K+ disease and Raynaud’s syndrome. Untreated supplements, salt substitutes containing K+, or phaeochromocytoma. Metabolic acidosis. other medicinal products that may increase K+ Pregnancy (unless necessary), lactation. levels, lithium. B Regular monitoring required. Withdraw A Hyperkalaemia, hypotension, renal gradually. Caution: Bronchospasm, diabetes impairment. mellitus with large fluctuations in blood glucose (hypoglycaemia symptoms can be masked), strict BREVIBLOC Baxter fasting, ongoing desensitisation therapy, AV block 3 N of 1st degree, Prinzmetal’s angina, peripheral Cardioselective b-blocker. Esmolol (HCl) 10mg/ml, arterial occlusive disease, general anaesthesia. In bronchial asthma or other COPD, bronchodilating 250mg/ml. Soln. 10mg/ml vial-5 x 10ml, A40.08; 250mg/ml amp.-1 x 10ml, A89.55. therapy should be given concomitantly. Psoriasis: D See 2.4, b-blockers Drug Presc. Notes. Assess risk/benefit. Phaeochromocytoma: Do not admin. until after a-receptor blockade. Symptoms Helsinn Birex of thyrotoxicosis may be masked. Contains lactose. BYTRITE Driving/operating machinery ability (at start of 2MO treatment, with alcohol). ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, C Contra: Floctafenin, sultopride. Not 10mg. Opaque hard gelatin caps. Yellow, light recommended: Ca++ antagonists (verapamil type orange, pink and blue cap with white bodies and diltiazem type), class I antiarrhythmics, printed 93 and 7209, 7210, 7211, 7212 resp. centrally acting antihypertensives. Caution: Ca++ 1.25mg-28, A4.14; 2.5mg-28, A5.89; 5mg-28, (dihydropyridine type (e.g. felodipine, A8.23; 10mg-28, A11.22. amlodipine), class-III antiarrhythmics (e.g. S Congestive heart failure (CHF), as amiodarone), topical b-blocking agents (e.g. eye adjunctive therapy to diuretics with or without drops for glaucoma treatment), cardiac glycosides. Acute MI. Patients with parasympathomimetics, insulin and oral increased cardiovascular risk of MI, stroke or antidiabetics, anaesthetic agents, digitalis cardiovascular death taking standard therapy or glycosides, NSAIDs, b-sympathomimetics that type 2 diabetic patients at risk. activate both b and a-adrenoreceptors (e.g. P CHF: Initially, 1.25mg once daily; may be noradrenaline, adrenaline), antihypertensives, doubled at intervals of 1-2 weeks. Dose r2.5mg tricyclic antidepressants, barbiturates, may be taken as single dose or two divided doses. phenothiszines. Mefloquine, MAOIs (except MAO- Max. 10mg daily. Post MI: Start treatment in B inhibitors). hospital between day 3 and 10 post MI. Initially, A Bradycardia, worsening of heart failure, 2.5mg twice a day, increased to 5mg twice a day dizziness, headache, GI complaints, feeling of after 2 days. If 2.5mg not tolerated, start with coldness or numbness in extremities, hypotension, 1.25mg twice a day for 2 days; withdraw asthenia, fatigue. 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, 2MO double after 1 week and after another 3 weeks Angiotensin II antagonist. Candesartan cilexetil up to 10mg daily (usual maintenance dose). 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white Q Not recommended. tab. 4mg: Round white tab. with single score line D History of angioneurotic oedema
BISOP
Rowex
3MO
22
CIRCULATORY SYSTEM 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.
BYZESTRA
Ergha
2MO Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. White tabs marked LSN followed by strength. 2.5mg-28, A5.21; 5mg-28, A7.35; 10mg-28, A9.07; 20mg-28, A10.42. S Heart failure (HF) as additive therapy to non-K+-sparing diuretics and where appropriate, digitalis. Acute MI in haemodynamically stable patients (SBPq100mmHg) without significant renal dysfunction as suppl. to standard therapy. P HF: 2.5mg in the morning; titrated in increments of 2.5mg at intervals of 2-4 weeks; maintenance, 5-20mg once daily; max. 35mg daily. MI: Initiate within 24 hrs of symptom onset in haemodynamically stable patients. Initially, 5mg daily, then 5mg after 24 hrs, 10mg after 48 hrs and thereafter 10mg once daily. Continue for 6 weeks. Min. maintenance dose, 5mg daily. Moderate renal impairment: As per elderly. 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.
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
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 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.
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
2.1
Pregnancy (except exceptional circumstances), lactation. B In patients with severe conduction Cardioselective b-blocker. Bisoprolol fumarate disturbances (high grade AV block, bifascicular or 1.25mg, 2.5mg, 3.75mg, 5mg, 7.5mg, 10mg. White, trifascicular block) or sinus node disease, only use white, off white, white-yellow, light yellow, light in conjunction with a pacemaker. Severe orange film ctd tabs. 1.25mg round, all others bradycardia and conduction disturbances may heart shaped and scored. 1.25mg-28, A5.96; occur at too high doses (discontinue). May occur: 2.5mg-28, A5.51; 3.75mg-28, A6.81; 5mg-28, Marked heart rate reduction (elderly); 2nd or 3rd A7.14; 7.5mg-28, A8.25; 10mg-28, A9.13. degree A-V block, sino-atrial block, or bifascicular S Stable chronic HF with reduced systolic block (discontinue); onset of new arrhythmias / left ventricular function in addition to ACE worsening of treated arrhythmias (sometimes inhibitors, and diuretics, and optionally cardiac fatal), hyperthyroidism (withdraw); peripheral glycosides. sensorimotor neuropathy and/or myopathy; P Patients should be stable when hypothyroidism or hyperthyroidism (monitor usTSH initiating treatment. If tolerated, titrate gradually before starting treatment). Monitor: Liver to 10mg once daily max. Initially 1.25mg once function, pulmonary function (particularly if daily for 1 week, 2.5mg once daily for a further pulmonary toxicity suspected). If blurred or week, 3.75mg once daily for a further week, 5mg decreased vision occurs, perform complete once daily for the following 4 weeks, 7.5mg once ophthalmologic examination. Caution: long-term daily for the following 4 weeks, 10mg once daily therapy. Instruct patients to avoid sun exposure. for maintenance therapy. Contains lactose and iodine. Q Not recommended. C Contra: Drugs which prolong QT D See 2.4, b-blockers Drug Presc. Notes. interval. Not recommended: b-blockers, diltiazem, Acute HF or during episodes of HF verapamil, stimulant laxatives, fluoroquinolones. decompensation requiring IV inotropic therapy. Caution: Oral anticoagulants, digoxin, phenytoin, B Require exp. in management of chronic diuretics, systemic corticosteroids, tetracosactride, HF. Observe patient for 4 hours after start of intravenous amphotericin, general anaesthesia, CAPTOR Rowex treatment. high dose oxygen therapy, flecainide, drugs 2MO metabolised by CYP3A4 (fentanyl, ciclosporin, CIBACEN Meda simvastatin, atorvastatin and lovastatin, tacrolimus, ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (12.5mg); white tabs. sildenafil, midazolam, triazolam, 2MO cloverleaf form with facet and quarter scored both ACE inhibitor. Benazepril (HCl) 5mg cap-shaped dihydroergotamine, ergotamine). Avoid grapefruit sides (25mg, 50mg). 12.5mg-60, A8.54; 100, juice. Advise patients to moderate alcohol levels. pale yellow film-ctd tab scored both sides and A14.25; 25mg-60, A9.73; 100-A16.22; 50mg-60, A Bradycardia, hypothyroidism, marked CG one side and LV on reverse. 10mg dark A16.60; 100, A27.67. hyperthyroidism, corneal microdeposits, GI yellow film-ctd tab marked CG one side and HO S Chronic heart failure with reduction of disorders, increased serum transaminases, acute on reverse. 5mg-28, A9.33; 10mg-28, A12.44. systolic ventricular function, in combination with liver disorders, extrapyramidal tremor, nightmares, S Adjunctive therapy in patients with diuretics and, if appropriate, digitalis and bsleep disorders, pulmonary toxicity, congestive heart failure. blockers. MI: Clinically stable patients within 1st 24 P Initially 2.5mg once daily. Titrate to photosensitivity, pigmentation on light exposed hours of an infarction; long term prevention in skin. max. 20mg once daily at 2-4 week intervals. clinically stable patients with asymptomatic left Q Not recommended. COVERSYL ARGININE Servier ventricular dysfunction. Macroproteinuric diabetic D Pregnancy, lactation. History of nephropathy in patients with type I diabetes. angioedema. 2MO P HF: Initially 6.25mg-12.5mg twice or B Salt and/or volume depletion. Renal ACE inhibitor. Perindopril arginine 5mg. Lightthree times daily; titrate by at least two week artery stenosis, renal impairment, surgery, green, rod-shaped scored film-ctd tab with a intervals to maintenance 75-150mg/day; anaethesia, CHF. symbol. 5mg-30, A14.12. max.150mg daily. Post-MI: Short term, initiate C Other anithypertensives, K+suppl., S Symptomatic heart failure. therapy with 6.25mg as soon as possible in K+sparing diuretics, lithium. P Initially 2.5mg in the morning (under patients with stable haemodynamics; 12 hrs later A Headache, upper respiratory tract medical supervision). If tolerated, can increase to 12.5mg; next days 100mg/day in two admins. for 4 symptoms, dizziness, fatigue, musculoskelatal pain, 5mg after 2 weeks. Severe HF: Initiate under weeks. Chronic, initiate therapy 3-16 days after MI cough, rhinitis, nausea, diarrhoea, rash. careful supervision. Renal insufficiency, 2.5mg with 6.25mg followed by 12.5mg 3 times daily for according to creatinine clearance. CORDARONE X sanofi-aventis Q Not recommended. 2 days and then 25mg 3 times daily; long-term treatment, 75-150mg daily in two or three doses. 2MO D ACE inhibitor hypersensitivity. History of Renal impairment: See SPC. Class III antiarrhythmic. Amiodarone (HCl) 100mg, angioneurotic oedema (previous ACE treatment), R Initially 6.25mg twice daily. 200mg. Round, white tab. with breakline one side, hereditary or idiopathic angioedema. Pregnancy, Q Initially 0.3mg/kg, or 0.15mg/kg in lactation. imprinted 100 or 200 on the other. 100mg-28, infants or renal dysfunction. Generally 3 times a A6.03; 200mg-28, A9.87. B Symptomatic hypotension may occur in day. S Tachyarrhythmias associated with Wolff- patients with salt or volume depletion. Caution: D Angioneurotic oedema. Pregnancy, Mitral valve stenosis, obstruction in the outflow of Parkinson-White syndrome. Atrial flutter and lactation. fibrillation where other drugs cannot be used. All the left ventricle. Renal impairment. Dialysis with B Renal impairment, renal artery stenosis, types of paroxysmal tachyarrhythmias where other highflux membranes. Kidney transplantation, no LV valvular and outflow tract obstruction, collagen drugs cannot be used. Prevention of ventricular data. Angioedema reported rarely (discontinue if vascular disease, patients at risk for occurs). Patients at risk of hyperkalaemia. Contains arrhythmias in high-risk patients following MI or hyperkalaemia, diabetes, hepatic impairment, lactose. Surgery, anaesthesia. in patients with clinical signs of CHF and/or LVEF anaesthesia. Neutropenia/ agranulocytosis, C Diuretics, K+ sparing diuretics, K+Q 40% receiving appropriate cardiac failure containing salt substitutes, K+ supplements, proteinuria. Contains lactose. treatment incl. ACE-inhibitors (under hospital/ lithium, NSAIDs, other antihypertensives and C K+sparing diuretics, K+suppl., diuretics, specialist supervision). vasodilators, antidiabetics, TCAs, antipsychotics, other anti hypertensive agents, lithium, TCAs, P 200mg three times daily for 1 week anesthetics, sympathomimetics. allopurinol, procainamide, cytostatic or then 200mg twice daily for 1 week. Maintain on A Headache, dizziness, vertigo, immunossupressive drugs, NSAIDs, min. effective dose, usually 200mg daily. paresthaesia, vision disturbance, tinnitus, sympathomimetics, antidiabetics. R Use minimum dose; monitor regularly. hypotension, cough, dyspnoea, GI disorders, rash, A Pruritus, rash, alopecia, dry cough, loss D Sinus bradycardia, sino-atrial heart block. Evidence or history of thyroid dysfunction. pruritus, muscle cramps, asthenia. of taste, dizziness, sleep disorders, GI disorders.
CARDICOR
Daiichi Sankyo/Merck Serono
3MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
23
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
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
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 0JN
CIRCULATORY SYSTEM nausea, GI disorders, rash, angioneurotic oedema, serum creatinine increase, hyperkalaemia.
EPANUTIN
Parke-Davis
2NO Class I antiarrhythmic. Phenytoin Na+ 50mg/ml. Soln for inj. or inf. Amp. 5ml x 10, A48.30.
Cephalon S Cardiac arrhythmias where 1st line
therapy is not effective, particularly digitalisinduced. P Initially 3.5-5mg/kg IV repeated once if 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 10mg-56, A4.43; 10mg-84, A6.64; 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 pink tab. marked A Headache, flushes, dizziness. BM K1; 6.25mg yellow tab. marked BM F1; 12.5mg peach tab. marked BM H3; 25mg off-white tab. DIOVAN Novartis ENAP Rowex marked BM D5. All scored. 3.125mg-28(Cal/Pk), 2MO A6.11; 6.25mg-28 (Cal/Pk), A7.26; 12.5mg-28 (Cal/ 2MO Angiotensin II antagonist. Valsartan 40mg, 80mg, Pk), A7.96; 25mg-28 (Cal/Pk), A9.54. ACE inhibitor. Enalapril maleate 5mg, 10mg, 160mg. Yellow, pale red, grey-orange film-ctd S Adjunctive therapy for the treatment of scored tabs. marked DO, D/V, and DX/DX resp. on 20mg. White, red and orange tabs marked EN 5, EN 10 and EN 20 resp. All scored, oblong. 5mg-30, symptomatic congestive heart failure to reduce one side and NVR on reverse. 40mg-28, A15.70; morbidity and increase patient well-being. A6.34; 10mg-30, A8.89; 20mg-30, A10.57. 80mg-28, A17.80; 160mg-28, A23.02. P Dosage should be titrate to individual S Heart failure (HF). HF prevention in S Clinically stable patients with requirements and monitored during up-titration. asymptomatic left ventricular dysfunction. symptomatic heart failure (HF) or asymptomatic Initially, 3.125mg twice daily with food for 2 left ventricular systolic dysfunction after recent (12 P Initially 2.5mg once daily increasing weeks. If tolerated, titrate at min. 2 week intervals gradually over 2-4 weeks to maintenance 20mg hrs-10 days) MI. Symptomatic HF when ACE to 6.25mg twice daily, then to 12.5mg twice daily, inhibitors could not be used, or as add-on therapy daily given in single or two divided doses. Max, then 25mg twice daily. Max. 25mg twice daily in 40mg daily in two divided doses. to ACE inhibitors when b-blockers could not be patients under 85kg, or 50mg twice daily in Q Not recommended. used. patients over 85kg. D Angioedema. Pregnancy, lactation. P HF: Initially 40mg twice daily; Q Under 18 years, not recomennded. B Kidney transplantation (avoid), renal uptitration to 80mg and 160mg twice daily (max. D See 2.4, b-blockers Drug Presc. Notes. artery stenosis, aortic or mitral valve stenosis, dose) at min. 2 week intervals to highest dose NYHA class IV decompensated HF requiring IV tolerated. Post-MI: After 12hrs, initially 20mg twice diabetes, collagen vascular disease, surgery, renal inotropic support, liver dysfunction. Contains impairment, jaundice (discontinue if occurs). daily; uptitration to target max. dose of 160mg lactose. twice daily. Use with ACE inhibitors in post-MI not Reduce dose of diuretic, if possible prior to therapy, as vol. depletion may cause symptomatic recommended. Mild to moderate hepatic HYPOVASE Pfizer hypotension. Contains lactose. impairment without cholestasis: Max. 80mg daily. 2MO Q Under 18 years, not recommended. C Other anti-hypertensive agents, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. D Pregnancy, lactation. Severe hepatic K+suppl., K+sparing and other diuretics, lithium, White tab. marked Pfizer and white tab. scored impairment, biliary cirrhosis and cholestasis, severe TCAs, antipsychotics, anaesthetics, renal impairment (cc Q10ml/min.), patients sympathomimetics, antidiabetics, antacids, NSAIDs, and marked M6, resp. B.D. Starter pack (8 x 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17; undergoing dialysis. Primary aldosteronism. alcohol, immunosuppressants, allopurinol, 1mg-56, A4.07. B Correct volume/salt depletion before procainamide. starting therapy. HF, recent MI; reduction in BP. A Blurred vision, dizziness, hypotension, S Congestive cardiac failure. Renal artery stenosis, kidney transplantation, headache, depression, cough, dyspnoea, asthenia, P Initially 500mcg two, three or four times 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. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion. 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.
24
Catecholamine. Dopexamine (HCl) 50mg/5ml. Amp. Concentrate for sln for infusion. 10 x 5ml, 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.
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
recent MI. P Maintenance dose, 50mg once daily. Initially, 25mg once daily, titrated to 50mg once daily preferably within 4 weeks, taking into account K+ level (see SPC). Start within 3-14 days after MI. Q Not recommended. D Serum K+q5mmol/L at initiation. Moderate to severe renal insufficiency, severe hepatic insufficiency. Lactation. B Monitor serum K+ at initiation and with 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 inhibitors or aII antagonists, a-1 blockers, TCAs, infarction, then 80mg twice daily. Arrhythmias: 10neuroleptics, 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.
daily, increasing to 4mg in divided doses; maintenance 4-20mg daily in divided doses. Q Not recommended. D Sensitivity other quinazolines. CCF due to aortic and mitral valve stenosis, pulmonary embolism and restrictive pericardial disease. B HF due to recent MI; insufficient data. Pregnancy, lactation. Initial low dose and gradual titration is recommended. C Other antihypertensives. Caution: PDE-5 inhibitors. A Dizziness, blurred vision, dry mouth, nausea, impotence.
2.1
C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.
LANOXIN
GSK
2MO Cardiac glycoside. Digoxin 0.25mg. White scored tab. marked WELLCOME X3A. 500, A8.37.
2MO ALSO LANOXIN-PG Digoxin 62.5mcg. Blue tab. marked WELLCOME U3A. 500, A7.85.
2MO 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, ISOKET 0.1% UCB elderly patients, renal insufficiency, thyroid dysfunction. INNOVACE MSD 2 N C Ca++ inj. or suppl., other cardiac Nitrate. Isosorbide dinitrate 1mg/ml. Amps.-10 x 2MO glycosides, K+depleting agents, quinidine, lithium, 10ml, A59.11; Bottles-50ml, A29.33; 100ml, ACE inhibitor. Enalapril maleate 2.5mg, 5mg, antacids, antibiotics. A40.50. 10mg, 20mg. 2.5mg: White, round, biconvex tabs. A GI, visual and conduction disturbances. 2N marked MSD 14; 5/10/20mg: White, rust-red and ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ peach rounded triangle-shaped tabs. scored on LESTACE Actavis one side and marked MSD 712, MSD 713 and MSD ml. 50ml, A15.69. 2MO S Unresponsive left ventricular failure A 714 resp. on the other. 2.5mg-28, 6.49; 5mg-28, ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. secondary to acute myocardial infarction, A5.93; 10mg-28, A8.31; 20mg-28, A 9.88. Round tabs, can be divided in equal halves. 2.5mg: S Treatment of symptomatic heart failure. unresponsive LVF of various aetiology. White, biconvex. 5mg: White, flat, scored both P 2-10mg/hour adjusting according to Prevention of symptomatic heart failure in sides. 10mg: Light pink, biconvex, scored one side. response. Max. 20mg/hour. patients with asymptomatic left ventricular 20mg: Pink, biconvex, scored one side. 2.5mg-28, Q Not recommended. dysfunction. A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, D Uncompensated cardiac shock. Severe P Initially 2.5mg in conjunction with A10.16. hypotension. Marked anaemia. Cerebral diuretics and, where appropriate, digitalis or bS Symptomatic HF. Short-term (6 weeks) haemorrhage. blockers; titrate over 2-4 weeks to usual treatment of haemodynamically stable patients maintenance dose of 20mg in single or twice daily A Headache, flushes, dizziness. within 24 hours of acute MI. dose. Max. 40mg daily in two divided doses. ISOPTIN Abbott P HF: Initially 2.5mg once a day under Q Not recommended. medical supervision. Increase to highest tolerated D Angioedema. Pregnancy, lactation. 2MO dose, up to max 35mg once a day by increments B Reduce dose of diuretic, if possible, Class I Ca++ antagonist. Verapamil 40mg, 80mg, of 10mg max and at intervals of 2 weeks before initiating therapy. Volume depletion may A 120mg. White film-ctd tabs. 40mg-100, 3.54; minimum. Acute MI: Do not start if systolic arterial cause symptomatic hypotension. LV valvular and 80mg-100, A7.07; 120mg-100, A10.60. pressure Q100mmHg. Initially (first 3 days postoutflow tract obstruction, renal impairment, renal S Supraventricular tachycardia, atrial MI), 5mg orally, followed by 5mg after 24 hours, artery stenosis, surgery. Angioneurotic oedema fibrillation and atrial flutter. 10mg after 48 hours and 10mg/day thereafter. (discontinue promptly). Contains lactose. P 40-80mg three times daily or 120-240mg Patients with low systolic arterial pressure C Other anti-hypertensive agents, lithium, twice daily. Higher dosage, see SPC. (R120mmHg) at start of treatment or within first K+suppl., diuretics, antidiabetics, TCAs, NSAIDs, Q Not recommended. 3 days of infarct: 2.5mg orally. Maintenance, 10mg sympathomimetics, alcohol, gold. 2NO once daily. Reassess after 6 weeks. If hypotension A Cough, nausea, blurred vision, dizziness, ALSO ISOPTIN INJECTION Verapamil 5mg/2ml occurs: 5mg with temporary decrease to 2.5mg if hypotension, syncope, angina pectoris, amp. 5, A6.44. necessary; withdraw if hypotension prolongs. tachycardia, headache, depression, dyspnoea, GI S Acute angina pectoris. Tachyarrhythmias Renal impairment, ccQ10ml/min, initially 2.5mg; disorders, taste alteration, rash, hypersensitivity/ and hypertensive crisis. 10QccQ30ml/min, initially 2.5-5mg; 31QccQ80ml/ angioneurotic oedema, asthenia, fatigue. P 1 amp. slow i.v. if necessary a second or min, initially 5-10mg/day. third at 5-10 mins. interval. Q Not recommended. INSPRA Pfizer Q Neonates, 0.75-1mg. Infants, 0.75mg. 1- D History of angioedema associated with 5MO 5 years, 2-3mg; 6-14 years, 2.5-5mg. previous ACE inhibitor therapy. Hereditary or Aldosterone antagonist. Eplerenone 25mg, 50mg. D Cardiogenic shock. 2nd or 3rd degree idiopathic angioedema. Pregnancy, lactation. Yellow film-ctd tab. marked Pfizer on one side, AV block. Severe bradycardia. Uncompensated B Caution: Acute MI (do not use: Renal and NSR over strengh on reverse. 25mg-28, cardiac failure. Sick sinus syndrome. dysfunction, systolic BP R100mmHg, cardiogenic A56.00; 50mg-28, A56.00. B 1st degree AV block. Poor cardiac shock), mitral stenosis and left ventricle outflow reserve should be controlled with digitalis and S In addition to standard therapy incl. bobstruction (aortal stenosis, hypertrophic diuretics. Hepatic impairment. Acute phase of blockers, in stable patients with left ventricular myocardiopathy), bilateral renal artery stenosis or myocardial infarction. Bradycardia. dysfunction (LVEFR40%) and heart failure after stenosis of the artery in a single kidney (strict AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
25
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
supervision with low doses; careful dose adjustment), pre-existing renal impairment (monitor blood K+, creatinine), major surgery, anaesthesia, renal insufficiency, diabetes. May occur: Systemic hypotension, angioedema (withdraw immediately if occurs), 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+ containing 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).
LEVOPHED
maintenance 5-20mg once daily. MI: Initially 5mg then 5mg 24 hours later, maintenance 10mg. R Initially 2.5mg increasing to 5-10mg once 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.
LOAVEL
cough.
METOCOR
Rowex
3MO Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg100, A3.50; 100mg-100, A6.50. S Prevention of cardiac mortality following myocardial infarction. Cardiac arrthythmias, especially supraventricular tachyarrhythmias. P Reinfarction, initial therapy: See SPC. Maintenance: 200mg daily. Arrythmias: 50mg two or three times daily; max. 300mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
METOP
Gerard
3MO
sanofi-aventis Cardioselective b-blocker. Metoprolol tartrate
Hospira 2 M O
0JN
ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, 10mg. White, yellow, red and white oblong tabs. Sympathomimetic amine. Noradrenaline (as acid with score line on both sides. 1.25mg-28, A5.29; tartrate) 1mg/ml. Amp. 6 x 2ml, A6.93. 2.5mg-28, A7.48; 5mg-28, A10.41; 10mg-28, LISOPRESS Niche A14.13. S Congestive heart failure; as adjunctive 2MO to diuretics with or without cardiac glycosides. ACE inhibitor. Lisinopril 2.5mg white scored tab. Post MI in patients with heart failure. Prevention marked 2.5; 5mg white scored tab. marked 5; of MI, stroke or cardiovascular death in patients 10mg white square tab. scored and marked 10; with an increased cardiovascular risk who are 20mg white pentagonal tab. scored and marked already taking standard therapy and in type 2 20. 2.5mg-28, A4.63; 5mg-28, A7.11; 10mg-28, diabetic patients with an increased cardiovascular A8.77; 20mg-28, A9.59. risk. S Adjunct to diuretics and where P CHF: Initially 1.25mg once daily, then appropriate digitalis in congestive heart failure. double dose at intervals of 1-2 weeks according to Acute MI in haemodynamically stable patients. response; max. 10mg daily. Reduce dosage of any P CHF, initially 2.5mg once daily in the diuretics first. Initiate therapy under close medical morning increasing gradually over 2-4 weeks to maintenance 5-20mg once daily. If possible reduce supervision. Post MI: Initiate in hospital between days 3-10 post-MI. Initially 2.5mg twice daily. After dose of any diuretic first. Initial therapy under 2 days, increase to 5mg twice daily. If starting close medical supervision (in hospital for severe dose not tolerated, reduce to 1.25mg twice daily unstable HF or high risk patients). Acute MI, for 2 days. Then increase to 2.5mg twice daily. If initially 5mg followed by 5mg after 24 hrs, 10mg necessary, increase to 5mg twice daily 2 days later. after 48 hrs and then 10mg once daily. Withdraw if dose cannot be increased to 2.5mg Q Not recommended. twice daily. Usual maintenance dose 2.5- 5mg D Pregnancy, lactation. Renal artery twice daily. Prevention of MI, stroke or stenosis, severe renal impairment, cardiovascular death: Initially 2.5mg once daily, haemodynamically relevant aortic or mitral valve stenosis, haemodynamically unstable patients after the dose is gradually increased. Double the dose after 1 week and after another 3 weeks increase acute MI. to 10mg. Usual maintenance dose is 10mg. B Haemodialysis. Hypotension, unstable R Consider initial dose of 1.25mg daily. cardiac failure, renal impairment, renovascular Titrate according to need for BP control. hypertension, primary hyperaldosteronism, proteinuria, angioneurotic oedema, aortic stenosis, Q Not recommended. D History of angiooedema. Aortic stenosis surgery/anaesthesia. or outflow obstruction. Renal artery stenosis, C K+ sparing diuretics, K+ suppl., diuretics, hypotensive or haemodynamically unstable states. Na+, Cl, antihypertensive agents, analgesics, antiPregnancy, lactation. inflammatory agents, lithium, alcohol, B CHF, hepatic impairment, blood anaesthetics, hypnotics, narcotics, dyscrasias. Renal impairment: Reduce dose and sympathomimetics, antacids. assess renal function prior to and during A Hypotension, dizziness, weakness, treatment. Caution: Patients with hyper stimulated impaired vision, syncope, tachycardia, palpitations, angiotension system. Electrolyte monitoring arrhythmias, chest pain, angina. recommended. Haemodialysis (avoid in patients dialysed with high flux membranes). Malignant LISPRIL Rowex hypertension: Initiate in hospital under close 2MO supervision. Symotomatic hypotension, ACE inhibitor. Lisinopril (dihydrate) 5mg, 10mg, agranulocytosis/bone marrow depression, 20mg. Slightly red scored tabs. 5mg-30, A8.13; hyperkalaemia have been reported rarely. Caution: A A 10mg-30, 10.03; 20mg-30, 11.51. Surgery and during anaesthesia. C Antihypertensive agents, K+sparing S Congestive heart failure as adjunctive therapy to non-potassium sparing diuretics. Acute diuretics, K+suppl., lithium, sympathomimetics, antidiabetic agents, NSAIDs. MI. A Nausea, dizziness, headache, dry tickling P HF: Initially 2.5mg in the morning,
26
CIRCULATORY SYSTEM
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.
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
hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia.
ctd sust.-release tab. marked SA one side, Napp 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. elderly; reduce dose. History of seizure (not S Symptomatic heart failure. Reduction of 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 NORTENOLOL Tillomed less than 2 weeks to 4mg once daily if tolerated. stimulation. 3MO CAD: Initially 4mg once daily; after two weeks PRINDACE Clonmel increase to 8mg once daily. Renal impairment: Cardioselective b-blocker. Atenolol 25mg, 2MO 50mg,100mg. White, white, orange unscored film- Based on cc (see SPC). R CAD: Initially 2mg once daily in 1st ctd tabs. marked A25, A50, A100 resp. 25mg-30, ACE inhibitor. Perindopril tert-butylamine 4mg. 30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. A12.07. week, then 4mg once daily the next week, then S Cardiac dysrhythmias. Early intervention up to 8mg once daily depending on renal S Symptomatic heart failure. function. in acute MI. P Initially 2mg daily; may be increased P 50-100mg daily. MI: 5-10mg atenolol IV Q Not recommended. after 2 weeks to 4mg once daily if tolerated. D Angioedema, history of ACEI related Renal impairment, see SPC. followed by 50mg tab 15min later and another angioedema. Pregnancy, lactation. Q Under 18 years, not recommended. 50mg tab 12 hours after IV inj. Then 12 hours B Symptomatic hypotension may occur. D Angioedema. Pregnancy, lactation. later, 100mg once daily. Renal impairment: See Correct salt depletion / hypovolaemia, if possible, B Increased risk of symptomatic SPC. prior to therapy. Monitor renal function and hypotension eg. salt depletion, hypovolaemia, Q Not recommended. serum K+ before and during treatment. Caution: diuretics; correct, if possible, prior to therapy. D See 2.4, b-blockers Drug Presc. Notes. Monitor BP, renal function, serum K+ closely, Severe HF impaired renal function, tendency for before and during treatment. Hyperkalemia, PENDREX Rowex electrolyte disturbance, mitral valve stenosis, obstruction in the outflow of the left ventricle, increases in blood urea and plasma creatinine. 2MO collagen vascular disease, anaesthesia (discontinue Caution: Mitral valve stenosis, obstruction in the ACE inhibitor. Perindopril tert-butylamine 2mg one day prior to surgery), patients at risk of outflow of left ventricle, diabetes. LDL apheresis. (1.67mg perindopril), 4mg (3.34mg perindopril). hyperkalemia. May occur: Unstable angina pectoris Jaundice, angioedema (facial/ intestinal) reported White, round, biconvex tablet debossed with 2 or (re-evaluate), jaundice, angioedema (promptly rarely; discontinue promptly. Discontinue one day 4 on one side. 2mg-30, A8.53; 4mg-30, A12.07. discontinue), anaphylactoid reactions (interrupt prior to surgery. Contains lactose. S Symptomatic heart failure. during LDL aphaeresis or desensitisation). Contains C Lithium, K+ supplements (not P Use in combination with a non K+lactose. recommended), diuretics. Caution: NSAIDs, sparing diuretic and/or digoxin and/or a b-blocker. C Not recommended: Lithium, K+-sparing antihypertensives, vasodilators, antidiabetics, Initially 2mg, may be increased to 4mg by anaesthetics, TCAs, antipsychotics, diuretics, K+ suppl, diuretics. Caution: increments of 2mg at intervals of no less than 2 Immunosuppressant, allopurinol or procainamide, sympathomimetics, injectable gold. weeks. Severe HF or high risk patients: Initiate A Hypotension, headache, dizziness, oral antidiabetics, NSAIDs, vasodilators, certain under careful supervision. Renal impairment: See vertigo, paraesthesia, vision disturbance, tinnitus, anaesthetics, TCAs, antipsychotics, SPC. cough, dyspnoea, GI disorders, dysgeusia, sympathomimetics. Q Not recommended. dyspepsia, rash, pruritus, muscle cramps, asthenia. A Headache, dizziness, vertigo, D History of angioedema associated with paresthaesia, vision disturbance, tinnitus, previous ACE inhibitor therapy. Hereditary or PRONESTYL BMS hypotension, cough, dyspnoea, GI disorders, rash, idiopathic angioedema. Pregnancy, lactation. pruritus, muscle cramps, asthenia. 2MO B If unstable angina pectoris occurs in 1st Class I antiarrhythmic. Procainamide (HCl) 250mg. month, reappraise benefit/risk before continuing PERFAN Myogen White scored tab. marked SQUIBB 754. 100, treatment. Volume depletion, symptomatic HF 2N A6.42. may cause symptomatic hypotension. Caution: S Cardiac arrhythmias. Selective inhibitor of PDE-III. Enoximone 5mg/ml. Mitral valve stenosis, aortic stenosis, hypertrophic P 50mg per kg daily in divided doses Amp. 10 x 20ml, A179.90. cardiomyopathy, collagen vascular disease, three to six hourly. S Congestive heart failure. immunosuppressant therapy, treatment with Q Not recommended. P Dilute before admin. Loading: Initially allopurinol or procainamide, diabetes. Renal 2NO 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. ALSO PRONESTYL INJECTION Procainamide (HCl) response to treatment. Anaphylactoid reactions 2.5-5mcg/kg/min. See SPC. 100mg/ml. 10ml multidose vial. 1, A2.21. may occur during dialysis with high flux Q Not recommended. P See SPC. membrane or low-density lipoproteins apheresis D Lactation. Q Not recommended. with dextran sulphate. Discontinue if angioedema B Monitor platelet counts, BP, heart rate, D AV block. SLE. occurs. May occur: Hepatic syndrome, neutropenia/ ECG, hepatic and renal function. Congestive B Elderly. Renal, hepatic or cardiac failure. agranulocytosis, thrombocytopenia, anaemia, cardiac failure associated with blood platelet Myasthenia gravis. Perform regular serological persistent non-productive cough, elevation in counts below 100,000/ml. Pregnancy. tests. Pregnancy. Contains: Na+ metabisulphite, serum K+. Discontinue 1 day prior to surgery. A Hypotension, chest pain, abnormal benzyl alcohol, Na+ (less than 1mmol/dose). C Avoid: Diuretics, K+ sparing diuretics, K+heart beat, breathlessness, headache, insomnia, A GI disturbance, SLE, leucopenia, containing salt substitutes, K+ supplements, nausea, vomiting, diarrhoea, chills, fever. agranulocytosis. lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, PHYLLOCONTIN CONTINUS RAMIC Pinewood antipsychotics, anaesthetics, sympathomimetics, Mundipharma 2 M O antacids. 2MO A Headache, dizziness, vertigo, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Hard paresthaesia, vision disturbance, tinnitus, Xanthine. Aminophylline 225mg. Pale yellow film- caps. with light grey body and light green, green, 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
27
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
CIRCULATORY SYSTEM
stenosis, haemodialysis patients, surgery. Discontinue if jaundice occurs. Driving/ operating machines. 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, renal dysfunction.
day 10 following AMI. Initially, 2.5mg twice daily for 2 days. Then increase to 5mg twice a day. Withdraw treatment if dose cannot be increased to 2.5mg twice daily. Maintenance: 2.5mg-5mg twice 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 RAMITACE Clonmel function prior to and during treatment. Caution: Impaired liver function, volume- and salt-depletion 2MO (symptomatic hypotension risk), anaesthesia, ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Cap.surgery. May occur rarely: Agranulocytosis and shaped, flat tabs. scored on one side. 2.5mg: bone marrow depression, reduction in red cell Yellow marked R2. 5mg: Pink marked R3. 10mg: count, haemoglobin content and platelet count, White marked R4. 2.5mg-28, A5.80; 5mg-28, hyperkalaemia, hyperkalaemia (hypertensive A8.10; 10mg-28, A11.04. patients), angioneurotic oedema. Avoid S High-risk patients with CVD or type 2 haemodialysis using high flux polyacrylonitrile diabetes with at least one additional risk factor. membranes and low-density lipoprotein apheresis Mild to moderate heart failure after acute stage with dextran sulphate. of MI. P CVD/diabetes: Initially, 1.25-2.5mg once C Caution: Antidiabetics, NSAIDs. A Nausea, dizziness, headache, daily; may be increased by doubling with min. 3 week interval. Maintenance, 5mg daily; max, 10mg symptomatic hypotension, MI, cerebrovascular accident, chest pain, palpitations, rhythm daily. HF after MI: Start at least 3 days after MI. disturbances, angina pectoris, impaired renal Initially, 1.25-2.5mg twice a day with strict function, GI disorders, hypersensitivity reactions, monitoring of BP and renal function; increase cutaneous and mucosal reactions, vasculitis, muscle after min. 2 days to 2.5-5mg twice a day. Target and joint pains, fever or eosinophilia, dry tickling dose, 5mg twice a day. Hypertension with HF: cough, disturbances of balance, nervousness, Initially 1.25mg once daily. On diuretics: restlessness, terror, sleep disorders, confusion, loss Discontinue diuretic 2-3 days before therapy (or of appetite, depressed mood, feeling of anxiety, earlier if long-acting). If diuretic cannot be paraesthesiae, taste change/reduction/loss, muscle discontinued, initial dose 1.25mg. Renal cramps, erectile impotence, reduced sexual desire, impairment: cc Q50ml/min, initially 1.25mg once increased blood urea nitrogen and serum daily; max. 5mg once daily; cc Q20ml/min, initially creatinine, deterioration of pre-existing 1.25mg every second day; max. 2.5mg once daily. proteinuria. Q Not recommended. RAMILO Rowex D Hypersensitivity to any ACE inhibitors. REVATIO Pfizer Angioneurotic oedema. Renal artery stenosis, 2MO 2NT kidney transplantation. Renal dysfunction or ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, Phosphodiesterase type 5 inhibitor. Sildenafil (as hypotension in patients with acute MI. Primary 10mg. White, oblong, biplane with facet tabs. citrate) 20mg. White, round, biconvex film-ctd tab. hyperaldosteronism. Pregnancy, lactation. marked R 1.25, R 2.5, R 5, and R 10 on one side. marked PFIZER on one side and RVT 20 on reverse. B Mitral valve stenosis or outflow Both sides with breaking notch. 1.25mg-30, A4.39; obstruction (caution). Jaundice (discontinue). 90, A553.95. 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, Haemodialysis using high-flux membranes (risk of S Pulmonary arterial hypertension A11.78. classified as WHO functional class III, to improve anaphylactoid reactions). Fluid/salt abnormalities, exercise capacity. S Symptomatic heart failure, cardiac severe hypertension, elderly. If potential for P 1 three times a day, approx. 6-8 hours failure following myocardial infarction (MI). symptomatic hypotension; monitor closely. apart. P CHF: Initially 1.25mg once daily Surgery/anaesthesia. Bone marrow depression, swallowed whole with plenty of fluid. May be hyperkalaemia, angioneurotic oedema have been Q Under 18 years, not recommended. increased at intervals of 1-2 weeks to 1.25mg reported. Contains lactose. Driving/using machines. D Severe hepatic impairment; recent stroke or MI, severe hypotension (BPQ90/ twice daily, then 2.5mg twice daily. Target, 10mg C Caution: K+ sparing diuretics, K+ daily. Uncomplicated cases, initially 1.25mg once supplements, diuretics, nitrates, other vasodilators, 50mmHg) at initiation; Retinitis pigmentosa; loss of vision in one eye because of non-arteritic daily, increased to 1.25mg twice daily on day 2-7, heparin, alcohol, allopurinol, procainamide, anterior ischaemic optic neuropathy (NAION). then to 2.5mg twice daily on week 2, and 5mg cytostatics or immunosuppressants, trimethoprim, Lactation, pregnancy (unless strictly necessary). twice daily on week 3. Maintenance, single or two antidiabetics, sympathomimetics, NSAIDs. Avoid B Caution: Hypotension, fluid depletion, divided doses. Post- MI: Initiate on day 3-10 after lithium. severe LV outflow obstruction, autonomic MI in stable patient with 1.25-2.5mg twice daily; A Dizziness and headache, orthostatic dysfunction; penis deformation, condition increase after no less than 2 days to 2.5-5mg twice effects, diarrhoea, vomiting, cough, renal predisposing to priapism; bleeding disorders, daily. Target, 5mg twice daily; later may be taken impairment. peptic ulceration. Signs of pulmonary oedema; as single daily dose. Max. 10mg daily. Concomitant potential for veno-occlusive disease. Contains diuretic treatment/ nephropathy: Initially 1.25mg RAMYTE Actavis lactose. Withdraw gradually. once daily. Renal impairment: See SPC. Impaired 2MO C Contra: Potent CYP3A4 inhibitors (eg. hepatic function: Max. 2.5mg daily. ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 ketoconazole, itraconazole, ritonavir), nitric oxide Q Not recommended. hard cap. containing white powder, with light donors (eg. amyl nitrite), nitrates, nicorandil. D Angioedema, history of angioedema grey body and resp. light green, green or dark Caution: Other CYP3A4 inhibitors, CYP3A4 with previous ACE inhibitor therapy. Pregnancy, green cap, marked R on cap and strength on substrates/ inducers, a-blockers. Bosentan, lactation. A A body. 2.5mg-28, 5.76; 5mg-28, 8.02; 10mg-28, epoprostenol, iloprost, other PDE5 inhibitors (no B If possible, discontinue diuretic A 10.92. data). treatment 2-3 days before therapy initiation. A Headache, flushing, limb pain, myalgia, Volume depletion may cause symptomatic S Reduces mortality in patients surviving dyspepsia, diarrhoea, cough, epistaxis, insomnia, hypotension. Caution: LV valvular and outflow acute MI with clinical evidence of HF. pyrexia, influenza, visual disturbances. tract obstruction, renal impairment, renal artery P Initiate in hospital between day 3 and
and dark green cap marked R on cap and strength on body. 2.5mg-28, A6.07; 5mg-28, A8.46; 10mg28, A11.54. S Congestive heart failure (CHF), as adjunctive therapy to diuretics with or without cardiac glycosides. Reduce mortality in patients surviving acute MI. P CHF: Patients stabilised on diuretic therapy, initially 1.25mg once daily; may be doubled at intervals of 1-2 weeks. Max. 10mg daily. Patients previously on high dose diuretic should have diuretic dose before starting. Post MI: Start treatment in hospital between day 3 and 10 post acute 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 before increasing to 2.5mg and 5mg twice a day; withdraw if cannot be increased 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.
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
CIRCULATORY SYSTEM RYTHMODAN RETARD
sanofi-aventis
CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
SOTOGER
Gerard
2MO
3MO
Class I antiarrhythmic. Disopyramide (as phos.) 250mg. White prolonged-release circular film-ctd tab. marked 013 on one side and E on the other. 56, A19.12. S Cardiac arrhythmias. P 1 tab. twice daily (morning and evening). Q Not recommended. D 2nd or 3rd degree AV block and sinus node disease in absence of pacemaker. Bundle branch block associated with 1st degree AV block. Double block (left posterior or anterior hemiblock and RBBB). Pre-existing long QT. Severe sinus node dysfunction. Severe heart failure, unless secondary 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 mineralo- corticoids, stimulant laxatives), anticholinergics, roxithromycin. A Arrhythmias, intra&ndash@rdiac conduction abnormalities, anticholinergic effects (dysuria, acute urinary retention, diplopia, accommodation disorders, GI disorders, impotence, psychiatric disorders).
Non-cardioselective b-blocker. Sotalol (HCl) 80mg, 160mg. White tabs. 80mg-28, A2.66; 160mg-28, A5.25. S Prophylaxis of and control of atrial flutter and fibrilation. Suppression and prevention of ventricular tachycardia. P Initially 80mg once or twice daily; maintenance, 160 mg twice daily. Max 640mg daily. Dose titration under close medical supervision and ECG control. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Prolonged QT interval, torsades de pointes, renal failure. 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
2.1
diuretics, mizolastine, terfenadine, quinine, ritonavir, lopinavar, indinavir, cimetidine, bupropion. A AV block, cardiac failure, chest pain, hypotension, MI, palpitation, nausea, abdominal pain, constipation, diarrhoea, flatulence, elevated liver enzymes, Hepatic dysfunction, dizziness, visual disturbances, blood dyscrasias, dyspnoea, depression, anxiety, insomnia, rashes, alopecia.
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, A3.28; 50mg-28, A4.24; 100mg-28, A5.39. 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. 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.
THELIN
Encysive
2JT
Endothelin A receptor antagonist. Sitaxentan (Na+) 100mg. Cap. shaped yellow-orange film-ctd tab. marked T-100. 28, A2538.05. S Pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity. P 1 once daily. Response should be seen by week 12, sometimes week 24. Q Under 18 years, not recommended. TAMBOCOR Meda D Mild to severe hepatic impairment. 2MO Elevated liver AST or/and ALT prior to treatment (q 3xULN). Lactation. Pregnancy (unless clearly Class I antiarrhythmic. Flecainide acetate 50mg white tab. marked 3M, TR50; 100mg white scored necessary). tab. marked 3M, TR100. 50mg-60, A21.21;100mg- B Monitor for signs of pulmonary oedema (consider veno-occlusive disease). Monitor AST/ALT 60, A23.32. levels prior to treatment and at monthly intervals S AV nodal reciprocating tachycardia. (see SPC if elevations). Check Hb levels prior to Wolff-Parkinson-White syndrome. Paroxysmal treatment, after 1 and 3 months, and every 3 atrial fibrillation and atrial flutter. Symptomatic months thereafter. Contains lactose. life threatening or disabling sustained ventricular C Contra: Ciclosporin A. Caution: tachycardia. Premature ventricular contractions Epoprostenol, sildenafil, iloprost, vitamin K and/or non-sustained ventricular tachycardia not SOTACOR BMS responding to other therapy. antagonists (e.g. warfarin, acenocoumarol and fenprocoumon), OATP inhibitors (e.g. some statins, 3MO P Supraventricular arrhythmias: Initially proteinase inhibitors, tuberculostatics), oral Non-cardioselective b-blocker. Sotalol (HCl) 80mg, 50mg twice daily; max. 300mg daily. Ventricular contraceptives, nifedipine, CYP2C9 substrates. arrhythmias: Initially 100mg twice daily; max. 160mg. Both white tabs. scored on one side and 400mg daily. Reduce after 3-5 days to lowest dose A Headache, insomnia, dizziness, tab. strength marked on other side. 80mg-28, peripheral oedema, nasal congestion, epistaxis, GI A2.67; 160mg-28, A5.26. required to maintain control. disorders, flushing, muscle cramp, fatigue, INR Q Under 18, not recommended. S Prevention of myocardial infarction. increased, prothrombin prolonged. 2N Cardiac arrhythmias. Angina. Hypertension. P Reinfarction: 320mg once daily, starting ALSO TAMBOCOR INJECTION Flecainide acetate TRACLEER Actelion A 5-14 days after infarction. Arrhythmias: Initial dose 10mg/ml; amp. 5 x 15ml, 29.20. 2NT 80mg either singly or as 2 divided doses. Allow 2-3 S Rapid control of ventricular days between increments. Most respond to dose Endothelin receptor antagonist (ERA). Bosentan tachyarrhythmias, AV nodal reciprocating of 160-320mg admin. in 2 divided doses at 12 hr tachycardia and Wolff-Parkinson White syndrome. (monohydrate) 62.5mg, 125mg. Orange-white intervals. In renal impairment; cc q60ml/min: film-ctd tab. marked with strength. 62.5mg-56, D Cardiac failure, history of MI with A2538.00; 125mg-56, A2538.00. Normal dose; cc 30-60ml/min: Half normal dose; cc asymptomatic ventricular arrhythmias, severe 10-30ml/min: Quarter normal dose; cc Q10ml/min: ischaemic heart disease, 2nd or 3rd degree AV S Primary pulmonary arterial hypertension Avoid. (PAH). PAH secondary to scleroderma without block, sinus node disease in absence of Q Not recommended. significant interstitial pulmonary disease. pacemaker. D See 2.4, b-blockers Drug Presc. Notes. P Initially 62.5mg twice daily for 4 weeks B Correct electrolyte disturbances before Prolonged QT interval, torsades de pointes, renal increasing to maintenance 125-250mg twice daily admin. Pacemakers or temporary pacing failure. electrodes. Renal or hepatic insufficiency; monitor morning and evening. B Caution: Pre-existing arrhythmias, QT Q Under 12 years, not recommended. plasma levels. Cardiac disease. Pregnancy. interval q 550msec. Electrolyte disturbances esp. D Moderate to severe hepatic impairment. C Other antiarrhythmics, digoxin, bhypokalaemia or hypomagnesaemia. Caution: Left blockers, other cardiac depressants (verapamil), Pregnancy. ventricular dysfunction, recent MI. See b-blockers B Treatment should be initiated and amiodarone, other Na+ channel blockers, Prescribing Notes. See 2.4, b-blockers Drug Presc. monitored by experienced physician. Women of fluoxetine, tricyclics, reboxetine, phenytoin, childbearing potential should practice reliable phenobarbital, carbamazepine, clozapine, Notes. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
29
2.1 CONGESTIVE
HEART FAILURE, TACHYCARDIA, POST-MI
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. TRANTALOL Pinewood C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, 3MO NSAIDs. Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White tabs. 25mg: Circular, flat, scored on A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver one side. 50mg and 100mg: Biconvex, film-ctd, marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mg- dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, 30, A3.90; 100mg-30, A5.50. angioneurotic oedema, syncope. S Cardiac arrhythmias. Early intervention in acute MI. Long-term prophylaxis after recovery UNIPHYLLIN CONTINUS from MI. Mundipharma P Arrhythmias: 50-100mg as single daily dose. MI: 50mg 15 mins orally and 12 hrs after IV 2MO dose. Then 100mg orally 12 hrs later once daily. Xanthine. Theophylline 200mg white cap. -shaped Renal failure: Reduce dose (see SPC). scored sust.-release tab. marked U200; 300mg Q Not recommended. white cap.-shaped scored sust.-release tab. marked D See 2.4, b-blockers Drug Presc. Notes. U300; 400mg white cap.-shaped scored sust.B Caution: Patients with poor cardiac release tab. marked NAPP U400 one side, reserve. Will reduce heart rate. Contains lactose UNIPHYLLIN on reverse. 200mg-56, A4.17; 300mg(50mg and 100mg). See 2.4, b-blockers Drug Presc. 56, A6.38; 400mg-56, A8.72. Notes. S Cardiac asthma, congestive cardiac C See 2.4, b-blockers Drug Presc. Notes. failure. A Precipitation of atrioventricular block, P Less than 70kg and elderly, 200mg 12 purpura, thrombocytopenia, impotence. See 2.4, b- hourly for 1 week, then 300mg 12 hourly or blockers Drug Presc. Notes. 600mg at night. Over 70kg, 200-300mg 12 hourly for 1 week, then 400mg 12 hourly or 800mg at TRITACE sanofi-aventis night. Q Not recommended. 2MO D Hypersensitivity to xanthine group of ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, drugs. Lactation. 10mg. White, yellow, red and white oblong tabs. B Other cardiac disease; liver disease. with score line on both sides. 1.25mg-28, A4.31; Peptic ulceration. Pregnancy. 2.5mg-28, A6.10; 5mg-28, A8.50; 10mg-28, C Cimetidine, erythromycin. b-adrenergic A11.57. agonists, glucagon, ephedrine, ciprofloxacin, S Adjunct to diuretics and where fluvoxamine, interferon, steroids, diuretics. See appropriate, digitalis in congestive heart failure. SPC. Post MI prevention of disease progression in A Nausea, gastric irritation, headache, CNS patients with heart failure. Prevention of MI, stimulants. stroke or cardiovascular death in patients with an increased cardiovascular risk who are already VASCACE Roche taking standard therapy and in type 2 diabetic 2MO patients with an increased cardiovascular risk. ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. P CHF: initially 1.25mg once daily, then double dose at intervals of 1-2 weeks according to White, yellow, red or brown oval film-ctd scored response; max. 10mg daily. Reduce dosage of any tabs. marked CIL and strength. 0.5mg-28, A5.02; diuretics first. Initiate therapy under close medical 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, A18.79. supervision. Post MI: initiate in hospital between days 3-10 post-MI. Starting dose 2.5mg twice daily. S Chronic heart failure usually as adjunctive therapy with digitalis and/or diuretics. After two days, increase to 5mg twice daily. If P Initially 0.5mg once daily under close starting dose not tolerated, reduce to 1.25mg supervision. Adjust according to response. twice daily for two days. Then increase to 2.5mg Maintenance usually 1-2.5mg once daily. Max. twice daily. If necessary, increase to 5mg twice 5mg once daily. daily two days later. Withdraw if dose cannot be increased to 2.5mg twice daily. Usual maintenance Q Not recommended. dose 2.5- 5mg twice daily. Prevention of MI, stroke D Ascites, aortic stenosis, hypertrophic cardiomyopathy or outflow obstruction. or cardiovascular death: the initial dose is 2.5mg Pregnancy, lactation. once daily, the dose is gradually increased. It is B Haemodialysis. Renal or hepatic recommended to double the dose after 1 week impairment, CHF, salt or volume depletion, and after another three weeks increase to 10mg. surgery, anaesthesia. Usual maintenance dose is 10mg. + R No special dosage recommendations for C K sparing diuretics, NSAIDs. elderly patients apart from general warning about A Headache, dizziness, fatigue, dyspepsia, patients with renal or hepatic insufficiency or CHF nausea, rash, coughing. Rarely angioneurotic which may be common in elderly and concomitant oedema and alterations in blood count. use of diuretic drugs. Dose titrated according to VENTAVIS Bayer Schering need for BP control. 2NT Q Not recommended. D History of angioneurotic oedema. Aortic Platelet aggregation inhibitor. Iloprost 10mcg/ml contraception. Monitor ALT/AST levels prior to and at monthly intervals during treatment. C Cyclosporin A, glibenclamide, warfarin, simvastatin, ketoconazole, digoxin. A Headache, upper RTI, nasopharyngitis, oedema, flushing, hypotension, abnormal hepatic function.
30
CIRCULATORY SYSTEM (as iloprost trometamol). 2ml nebuliser sln in amps. Price available on request. S Primary pulmonary hypertension, classified as NYHA functional class III, to improve exercise capacity and symptoms. P 2.5mcg or 5mcg (as delivered at the mouthpiece of nebuliser) 6 to 9 times per day. Use with recommended nebulisers. Q Under 18 years, no experience. D Conditions increasing risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage). Severe CHD or unstable angina, MI within last six months, decompensated cardiac failure if not under close medical supervision, severe arrhythmias, cerebrovascular events (e.g. TIA, stroke) within last 3 months. Pulmonary hypertension due to venous occlusive disease. Congenital or acquired valvular defects with myocardial function disorders not related to pulmonary hypertension. Pregnancy, lactation. B Unstable pulmonary hypertension with advanced right HF (not recommended). Acute pulmonary infections (monitor). Systolic arterial hypotension Q85mmHg (not recommended). Hepatic dysfunction or renal failure requiring dialysis. Caution with discontinuation. C Caution: Vasodilatators and antihypertensive agents, anticoagulants or other inhibitors of platelet aggregation. A Vasodilatation, hypotension, syncope, increased cough, headache, trismus.
VERAMIL
Orion
2MO Class I Ca++ antagonist. Verapamil chlor. 40mg, 80g, 120mg. White film-ctd tabs. coded VL-40, VL80 and VL-120. 40mg-100, A5.17; 80mg-100, A8.67; 120mg-100, A11.56. S Supraventricular tachycardias and prevention of recurrence. P 40-120mg three to four times daily. Severe liver dysfunction: Use 1/3 dose. D Severe left ventricular dysfunction. Severe hypotension, cardiogenic shock. 2nd or 3rd degree AV block. Marked bradycardia. Sick sinus syndrome. CHF incl. including uncompensated HF. Lactation. B 1st degree AV block reported. Hypertrophic cardiomyopathy, elderly, attenuated neuromuscular transmission. Mild to moderate HF (control with digitalis and diuretics). Porphyria (unsafe). Hepatic impairment (monitor during long-term therapy). Contains lactose. Pregnancy. C Grapefruit juice, digitalis intoxication, IV b-blockers (contra). Colchicine, cisapride (avoid). a/ b-blockers, CYP3A4 inhibitors/substrates, antiarrhythmics, CCBs, cardiac glycosides, theophylline, imipramine, glyburide, doxorubicin, paclitaxel, tamoxifen, cimetidine, statins, almotriptan, halothane, dantrolene, Ca++ salts, alcohol, lithium, timolol eye drop, quinidine, antihypertensives. A Constipation, headache, dizziness, fatigue, rash, bradycardia, hypotension, cardiac insufficiency, swelling of ankles.
VERISOP
Gerard
2MO Class I Ca antagonist. Verapamil chlor. 40mg, 80g, 120mg. White tabs. marked VL and strength one side, G on reverse. 40mg-100, A3.53; 80mg100, A5.16; 120mg-100, A10.59. S Superventricular tachycardia. P 40-120mg three times 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
ANGINA 2.2
stenosis, hypertrophic cardio-myopathy. Systolic BP Q100mmHg before treatment initiation. Permanent haemodialysis. Primary hyperaldosteronism. B Diuretics (q80mg frusemide), hypovolaemia, hyponatraemia, hyperkalaemia. Hypotension (first dose). Acute MI and cardiac failure (if unstable), renal impairment, high-dose vasodilator therapy. LDL-cholesterol apheresis. Elderly. C Diuretics incl. K+sparing, K+suppl., other VOLIBRIS GSK antihypertensives, analgesics/anti-inflammatories, lithium, alcohol, anaesthetics, narcotics, hypnotics. 2T Ambrisentan 5mg, 10mg. Resp. pale pink or deep Sympathomimetics, oral antidiabetic agents, insulin. pink, square or oval film-ctd tab. with GS on one A Hypotension, dizziness, fatigue, side and K2C or KE3 on the other. Prices on arrhythmias. Proteinuria, dry cough, nausea request. (occasionally), abdominal pain, rash, headache. S Pulmonary arterial hypertension (PAH) WHO functional class II and III, to improve exercise ZESTAN Clonmel capacity. 2MO P 5mg once daily. If well tolerated, may be increased to 10mg in WHO class III PAH ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. patients. Severe renal impairment: Initiate marked with strength and scored both sides; cautiously. 10mg, 20mg white tabs. marked with strength and quadrisected both sides. 2.5mg-28, A4.84; Q Under 18 years, not recommended. 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. D Pregnancy. Women of child-bearing potential not using reliable contraception. S Adjunct to diuretics and where Lactation. Severe hepatic impairment. AST and/or appropriate, digitalis, in congestive heart failure. ALT q3xULN. Treatment of acute MI in haemodynamically stable B Safety not established in WHO patients. functional class I PAH. Evaluate ALT and AST prior P CHF, initially 2.5mg once daily to initiation and monitor during treatment; increasing in intervals of 2-4 weeks to 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 recommended: Clinically significant anaemia. under close medical supervision (in hospital for Regularly measure Hb and/or haematocrit levels. severe or unstable HF or high risk patients). Post Peripheral oedema may occur (increased frequency MI, initially 5mg followed by 5mg after 24 hrs, and severity over 65 years). Monthly pregnancy 10mg after 48 hrs, and then 10mg once daily. tests recommended. Contains soya, lactose, Allura Q Not recommended. red AC. D Angioneurotic oedema, severe renal C Caution: Cyclosporine A, other PAH impairment, haemodynamically unstable patients treatments (e.g. prostanoids, PDE-5 inhibitors). after MI, haemodynamically relevant aortic or A Palpitation, anaemia, headache, upper mitral valve stenosis or hypertrophic respiratory congestion, sinusitis, nasopharyngitis, cardiomyopathy, systolic BP R 100 mmHg before rhinitis, GI disorders, flushing, peripheral oedema, initiation of treatment, cardiogenic shock. fluid retention. B Haemodialysis. Hypotension, renovascular hypertension, renal impairment, ZESGER Gerard monitor renal function before and during treatment, severe CHF, primary 2MO ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. hyperaldosteronism, aortic stenosis, hypertrophic cardiomyopathy. Low-density apheresis/ Round, flat beveled edge, square biconvex and desensitisation therapy. pentagonal biconvex tabs. debossed on one side C Diuretics, K+ sparing diuretics, K+ suppl., with 2.5, 5, 10 and 20 resp. All white with breakline on other side. 2.5mg-28, A5.38; 5mg-28, Na+ Cl, lithium, anti-hypertensives, analgesics, anti-inflammatories, alcohol, anaesthetics, A7.59; 10mg-28, A9.37; 20mg-28, A10.75. S Heart failure as additive therapy to non- narcotics, hypnotics, sympathomimetics, oral antidiabetics, insulin, antacids, NSAIDs. + K sparing diuretics, and digitalis (where A Hypotension, angioedema, dizziness, appropriate). Acute MI in haemodynamically weakness, impaired vision, renal dysfunction, dry stable patients, in addition to usual standard cough, sore throat, hoarseness, bronchitis, GI therapy in MI, especially together with nitrates. disturbances, rash, headache, tiredness. P Initially 2.5mg in the morning. 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.
Maintenance dose titrated by 2.5mg increments according to patient response. Time interval between dose increases q2 weeks but preferably 4 weeks; max. 35mg daily. Post MI: initially 5mg, then 5mg after 24hours, 10mg after 48 hours and thereafter 10mg once daily. Low systolic BP: initially 2.5mg. Hypotension: max. daily dose 5mg, with reduction to 2.5mg if necessary. If hypotension persists on 2.5mg, discontinue. Q Not recommended. D Pregnancy, lactation. Renal artery stenosis, post kidney transplant. History of angioneurotic oedema. Aortic or mitral valve
ZESTRIL
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.
ZOFENIL
A. Menarini
2MO Cardioprotective ACE inhibitor. Zofenopril 7.5mg. White film-ctd. tab. 12, A2.91. S Post acute MI, with or without heart failure if haemodynamically stable and not on antithrombolytic therapy. P First and second day, 7.5mg 12 hourly, third and fourth day, 15mg 12 hourly, increasing on fifth day to 30mg 12 hourly. R Use with caution in those over 75 years. Q Not recommended. D Angioneurotic oedema, severe hepatic impairment, renal artery stenosis. Pregnancy, lactation. Women of child-bearing potenial unless protected by effective contraception. B Reduce dosage of diuretic if possible before initiating therap. Volume depletion may cause sympathetic hypotension, dialysis, anaesthesia, renal or heptic impairment. C Other anti-hypertensive agents, diuretics, lithium, K+sparing diuretics, K+suppl., NSAIDs. A Dizziness, fatigue, headache, cough, nausea, vomiting, rash, muscle cramp, weakness.
2.2 ANGINA
ADALAT LA
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 Chronic stable angina pectoris. P Initially 30mg once daily in the morning. Increase if necessary up to max. 90mg once daily. Tabs. must be swallowed whole with water. Q Not recommended.
2MO
AstraZeneca ALSO ADALAT RETARD 10 Nifedipine 10mg. Pink-
2MO ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. White, pink, pink, red tabs. resp. marked with heart shape, strength and ZESTRIL. 2.5mg-28, A5.39; 5mg-28, A7.60; 10mg-28, A9.38. 20mg-28, A10.76. S Adjunctive therapy in congestive heart failure with non-potassium sparing diuretics with or without digitalis. Acute myocardial infarction. P CHF: Initially 2.5mg once daily increasing gradually to 5-20mg once daily,
grey tab. marked A10 one side, 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 ADALAT Nifedipine 5mg, 10mg. Orange, gelatin ovoid caps. containing yellow fluid. 5mg90, A6.32; 10mg-90, A8.02. P Initially 5mg eight hourly adjusted according to response, increasing to max. 20mg
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
31
2.2 ANGINA
CIRCULATORY SYSTEM
outflow-tract of left ventricle (e.g. high grade aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. B Hepatic impairment, cardiac failure, low cardiac reserve, elderly. C Caution: CYP3A4 inhibitors/inducers. AMLID Pinewood Other antihypertensives (e.g. a/b blockers, ACEinhibitors, diuretics). 2MO A Ankle swelling, headache, facial Ca++ antagonist. Amlodipine 5mg, 10mg (as flushing, dizziness, fatigue, asthenia, palpitations, amlodipine maleate). White round biconvex tab. abdominal pain, nausea, dyspepsia. 10mg tab. scored on both sides. 5mg-28, A9.19; 10mg-28, A13.70. AMLOTAN Clonmel S Chronic stable and vasospastic angina 2MO pectoris. ++ P 5mg once daily with water. If no effect Ca antagonist. Amlodipine 5mg, 10mg (as within 2-4 weeks, may be increased to max. 10mg amlodipine mesilate monohydrate). White round biconvex tab embossed with 5 or 10 resp. 10mg once daily. May be used as monotherapy or in tab. scored. 5mg-28, A7.34; 10mg-28, A10.97. combination with other antianginal drugs. S Chronic stable and vasospastic angina Q Under 12 years, not recommended. pectoris. D Severe hypotension, shock, HF after P 5mg once daily with water. If no effect acute MI (during 1st 28 days), obstruction of within 2-4 weeks, may be increased to max. 10mg outflow tract of left ventricle (e.g. high grade ADIZEM XL CAPSULES Mundipharma aortic stenosis), unstable angina pectoris. once daily. 2MO Q Under 18 years, not recommended. Pregnancy (unless essential), lactation. D Severe hypotension, shock, HF after B Low cardiac reserve, cardiac failure, Class III Ca++ antagonist. Diltiazem (HCl) 120mg acute MI (during 1st 28 days), obstruction of hepatic impairment, elderly. Contains lactose. pink/blue cap.; 180mg pink/blue cap.; 240mg red/ outflow tract of left ventricle (e.g. high grade C Caution: CYP3A4 inhibitors/ inducers, blue cap.; 300mg maroon/blue cap. All cont.aortic stenosis), unstable angina pectoris. other antihypertensives incl. b-blockers. release caps. marked with DCR and strength. Pregnancy (unless essential), lactation. A Ankle swelling. Headache, fatigue, 120mg-28, A8.40; 180mg-28, A12.45; 240mg-28 A16.05; 300mg-28, A12.42. B Low cardiac reserve, cardiac failure, dizziness, asthenia, palpitations, flushing, nausea, hepatic impairment, elderly. dyspepsia, abdominal pain. S Angina. C Caution: CYP3A4 inhibitors/ inducers, P Initially 240mg once daily adjusting Gerard other antihypertensives incl. b-blockers. according to response. Caps. should be swallowed AMLIST A Ankle swelling. Headache, fatigue, whole. 2MO dizziness, asthenia, palpitations, flushing, nausea, R Initially 120mg once daily and carefully Ca++ antagonist. Amlodipine 5mg, 10mg (as titrate as required. amlodipine maleate). White round tab. 10mg with dyspepsia, abdominal pain. Q Not recommended. break score on both sides. 5mg-28, A9.20; 10mgAMOLIN Ergha 2MO 28, A13.75. 3MO ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg S Chronic stable and vasospastic angina white cap.; 120mg brown/white cap.; 180mg Cardio-selective b-blocker. Atenolol 25mg, 50mg, pectoris. brown/white cap. All cont. -release caps. marked P 5mg once daily with water. If no effect 100mg. White film-ctd tabs. marked C23, C24 and with strength. 90mg-56, A12.80; 120mg-56, within 2-4 weeks, may be increased to max. 10mg C25 resp. 25mg-30, A2.60; 50mg-30, A3.93; A14.21; 180mg-56, A21.32. 100mg-30, A5.16. once daily. May be used as monotherapy or in P Initially 90mg twice daily. Increase S Angina pectoris. combination with other antianginal drugs. gradually to 120mg or 180mg twice daily as P 50-100mg daily. Q Under 18 years, not recommended. Q Not recommended. required. D Severe hypotension, shock, HF after D See 2.4, b-blockers Drug Presc. Notes. R Start at lowest level of 90mg twice acute MI (during 1st 28 days), obstruction of daily; carefully titrate as required. outflow tract of left ventricle (e.g. high grade ATECOR Rowex Q Not recommended. aortic stenosis), unstable angina pectoris. D Pregnancy, lactation. Sick sinus Pregnancy (unless essential), lactation. 3MO syndrome, 2nd or 3rd degree AV block, marked B Low cardiac reserve, cardiac failure, Cardioselective b-blocker. Atenolol 25mg, 50mg, bradycardia, decompensated cardiac failure. hepatic impairment, elderly. Contains lactose. 100mg. White scored film-ctd tabs. 25mg-30, B Mild bradycardia, prolonged PR interval. Driving or using machines. A2.67; 50mg-30, A4.04; 100, A12.84; 100mg-30, Measure heart rate regularly in elderly and in A5.77; 100, A18.67. C Caution: CYP3A4 inhibitors/ inducers, patients with hepatic or renal impairment. other antihypertensives incl. b-blockers. S Angina pectoris. Diabetes. A Ankle swelling. Headache, fatigue, P 100mg once daily or 50mg twice daily. dizziness, asthenia, palpitations, flushing, nausea, Q Not recommended. dyspepsia, abdominal pain. D See 2.4, b-blockers Drug Presc. Notes. 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.
C b-blockers, digoxin, cimetidine, diazepam, antihypertensives, anaesthetics, dantrolene inf. A Anorexia, nausea, bradycardia, oedema, rash, flushing, fatigue, AV block.
Anti-Doping Information
ATENI
s
AMLODE
3MO
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.
2MO Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine besilate). White oblong, bevelled tab. scored on one side and marked with strength on reverse. 5mg-28, A8.33; 10mg-28, A12.50. S Chronic stable and vasospastic angina pectoris. P 5mg once daily with water. If no sufficient effect within 2-4 weeks, may be increased to 10mg daily (as single dose). Q Under 18 years, not recommended. D Hypersensitivity to dihydropyridine derivatives. Severe hypotension, shock, HF after acute MI (during 1st 28 days), obstruction of
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 Angina pectoris. P 100mg once daily or 50mg twice daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
32
Rowex
Gerard
ATENOGEN
Antigen
3MO Cardioselective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange film-ctd tabs.
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
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.
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, A3.51; 100mg-100, A6.52. S Angina. P 50-100mg twice or three times daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
BISOCOR
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.
BISOPINE
Pinewood
3MO Cardioselective b-blocker. Bisoprolol hemifumarate
Niche 5mg, 10mg. Resp. pale yellow or beige mottled
tabs. marked BI above breakline 5 or 10 below. 5mg-28, A5.90; 10mg-28, A6.65. S Chronic stable angina pectoris. P Usually 10mg once daily; max. 20mg daily. Upon discontinutation, diminish slowly by weekly halving dose. Severe renal impairment: Max dose 10mg daily R Lowest dose recommended. Regular monitoring during treatment initiation. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. Combinations with floctafenine and sultopride. B See 2.4, b-blockers Drug Presc. Notes. Iodated contrast products. Driving/operating Cardioselective b-blocker. Bisoprolol fumarate machinery. Contains lactose. 5mg, 10mg. Resp. yellow or apricot, round film-ctd C See 2.4, b-blockers Drug Presc. Notes. tablet with a cross score encoded BIS and strength 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 Angina pectoris. Headache. P Should be taken with liquid (not chewed), in the morning. Initially 5mg; usual dose DILTAM RETARD Rowex 10mg once daily; max 20mg/day. 2MO Q Not recommended. Class III Ca++ antagonist. Diltiazem (HCl) 90mg. D Acute HF or during episodes of HF White sust.-release tab. 60, A12.38. decompensation requiring IV inotropic therapy. S Angina pectoris incl. Prinzmetal’s Cardiogenic shock. AV block of 2nd or 3rd degree angina. (without a pacemaker). Sick sinus syndrome. P Initially 60mg twice daily increasing to Sinoatrial block. Bradycardia (Q 60 beats/min) 90mg twice daily. before start of therapy. Hypotension (systolic BP R Initially 60mg twice daily increasing Q 100mmHg). Severe bronchial asthma or severe gradually. COPD. Late stages of peripheral arterial occlusive Q Not recommended. disease and Raynaud’s syndrome. Untreated D Pregnancy, lactation. Sick sinus phaeochromocytoma. Metabolic acidosis. syndrome, 2nd or 3rd degree AV block, marked Pregnancy (unless necessary), lactation. bradycardia, decompensated cardiac failure. B Regular monitoring required. Withdraw B Mild bradycardia, prolonged PR interval. gradually. Caution: Bronchospasm, diabetes Measure heart rate regularly in elderly and in mellitus with large fluctuations in blood glucose patients with hepatic or renal impairment. (hypoglycaemia symptoms can be masked), strict fasting, ongoing desensitisation therapy, AV block Diabetes. C b-blockers, digoxin, cimetidine, of 1st degree, Prinzmetal’s angina, peripheral diazepam, antihypertensives, anaesthetics. arterial occlusive disease, general anaesthesia. In A Anorexia, nausea, bradycardia, oedema, bronchial asthma or other COPD, bronchodilating rash, flushing, fatigue, AV block, headache, GI therapy should be given concomitantly. Psoriasis: disturbance. Assess risk/benefit. Phaeochromocytoma: Do not admin. until after a-receptor blockade. Symptoms DILZEM XL Cephalon of thyrotoxicosis may be masked. Contains lactose. 2MO Driving/operating machinery ability (at start of Class III Ca++ antagonist. Diltiazem (HCl) 120mg, treatment, with alcohol). 180mg, 240mg. Prolonged release hard capsules C Contra: Floctafenin, sultopride. Not marked with cap. strength and logo. 120mg-28, recommended: Ca++ antagonists (verapamil type A8.39; 180mg-28, A12.44; 240mg-28, A16.06. and diltiazem type), class I antiarrhythmics, S Angina pectoris, incl. Prinzmetal’s centrally acting antihypertensives. Caution: Ca++ angina. Mild to moderate hypertension. (dihydropyridine type (e.g. felodipine, P 180mg once daily increasing gradually, amlodipine), class-III antiarrhythmics (e.g. as necessary to 360mg once daily. amiodarone), topical b-blocking agents (e.g. eye R Initially 120mg once daily, increasing drops for glaucoma treatment), gradually. parasympathomimetics, insulin and oral Q Not recommended. antidiabetics, anaesthetic agents, digitalis 2MO glycosides, NSAIDs, b-sympathomimetics that ALSO DILZEM SR Diltiazem (HCl) 60mg, 90mg, activate both b and a-adrenoreceptors (e.g. 120mg. Prolonged release hard capsules marked noradrenaline, adrenaline), antihypertensives, with cap.strength. 60mg-56, A8.12; 90mg-56, tricyclic antidepressants, barbiturates,
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, A5.28. 10mg-28, A5.99. ATENOMEL Clonmel S Chronic stable angina. 3MO P Usually 10mg once daily. Max. 20mg Cardioselective b-blocker. Atenolol 25mg, 50mg, daily. 100mg. White tab. marked C23, C24, C25. 50 and Q Not recommended. 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; D See 2.4, b-blockers Drug Presc. Notes. 100mg-30, A5.01. Acute HF or during episodes of HF S Angina pectoris. decompensation requiring IV inotropic therapy. P 50-100mg daily. Q Not recommended. BISOP Rowex D See 2.4, b-blockers Drug Presc. Notes. 3MO
BETA-ADALAT
Bayer Schering
3MO Cardioselective b-blocker/class II Ca antagonist. Atenolol 50mg, slow release nifedipine 20mg. Reddish-brown cap. marked with name and Bayer cross. 28 (Cal/Pk), A11.87. S Chronic stable angina pectoris, where b -blocker or calcium antagonist monotherapy is inadequate. P 1 every 12 hours. If necessary prophylactic nitrate therapy or additional nifedipine may be given. Q Not recommended. D Women of child bearing potential. HF. 2nd or 3rd degree heart block. Cardiogenic shock, use in conjunction with other cardio-depressant drugs, severe bradycardia, acute angina attacks, unstable angina pectoris, severe aortic stenosis, during or within one month of MI, wheezing, asthma, severe renal failure. Pregnancy, lactation. B Cardiac conduction defects or poor cardiac reserve. OAD. Renal or hepatic impairment. Diabetes. Anaesthesia. Elderly. C Antihypertensives, cimetidine, quinidine, rifampicin, digoxin, cardiodepressants, adrenergicneurone blocking drugs, non-cardio-selective bblockers, grapefruit juice. A Flushing, headache, fatigue, dizziness, dry eyes, skin rash, oedema, hypersensitivity type jaundice (rare), gingival hyperplasia, gynaecomastia, impotence. Mood changes, MI, ischaemic pain (discontinue). ++
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 Angina. P 80mg 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.
BETALOC
AstraZeneca
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
33
2.2 ANGINA
CIRCULATORY SYSTEM
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.
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, ELANTAN LA UCB decompensated cardiac failure. B Mild bradycardia, prolonged PR interval. 2MO Nitrate. Isosorbide mononitrate 25mg brown/white Measure heart rate regularly in elderly and in patients with hepatic or renal impairment. sust.-release cap., 50mg brown/flesh sust.-release C b -blockers, digitalis. cap. 25mg-28 (Cal/Pk), A7.63; 50mg-28 (Cal/Pk), A Anorexia, nausea, bradycardia, oedema, A13.12. rash, flushing S Prophylaxis of angina pectoris. P 25-50mg in the morning swallowed GLYTRIN SPRAY Pharmasol whole. 2MO Q Not recommended. 2MO Nitrate. Glyceryl trinitrate 0.4mg/metered dose. CFC-free spray. 200 dose unit, A3.89. ALSO ELANTAN Isosorbide mononitrate 10mg, S Treatment and prophylaxis of angina 20mg, 40mg. White scored tabs. marked E10, E20 pectoris and treatment of variant angina. or E40. 10mg-56, A4.43; 10mg-84, A6.64; 20mgP 1-2 doses as required for relief of 56, A5.64; 20mg-84, A8.00; 40mg-56, A9.20; angina pain or for short-term prophylaxis before 40mg-84, A13.77. exercise. Max. 3 doses per angina attack. All by P Initial dosage for patients not already receiving prophylactic nitrate therapy, 10mg twice sublingual admin. daily, dose may be increased to 10mg three times Q Not recommended. D Hypotensive disorders incl. shock, severe daily. Others, 40-80mg daily in two or three anaemia, cerebral haemorrhage and brain trauma, divided doses after meals. Max. 120mg daily. mitral stenosis, angina caused by hypertrophic Q Not recommended. obstructive cardiomyopathy. D Acute MI and cardiac shock. Severe C Alcohol. Cross tolerance to other hypotension. nitrates. C Alcohol. A Headache, flushing, postural A Headache, flushes, dizziness. hypotension, tachycardia and paradoxical EMCOLOL Gerard bradycardia.
3O 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 Angina pectoris P Usually 10mg once daily. Max. 20mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
IKOREL
sanofi-aventis
2MO
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 EMCOR Daiichi Sankyo/Merck Serono susceptible to headache, initially 5mg daily. Q Not recommended. 3MO D Cardiogenic shock with depleted blood Cardioselective b-blocker. Bisoprolol fumarate volume, hypotension, LV failure with low filling 5mg, 10mg. Yellow and orange biconvex film-ctd pressure or acute pulmonary oedema and heart-shaped scored tabs. 5mg-28, A5.94; 10mgmyocardial infarction. Pregnancy, lactation. 28, A6.68. C Antihypertensive drugs, TCADs. S Angina pectoris. A Headache, flushing, nausea, dizziness, P Usually 10mg once daily; max. 20mg hypotension and tachycardia. daily. In some 5mg/day may be adequate. Final stage impairment of renal function or liver IMDUR AstraZeneca function: Max. 10mg once daily. 2MO Q Not recommended. Nitrate. Isosorbide mononitrate 60mg. Yellow oval D See 2.4, b-blockers Drug Presc. Notes. film-ctd sust.-release tab. scored and marked A/ID. Acute HF or during episodes of HF 28, A10.60. decompensation requiring IV inotropic therapy.
34
S Prophylaxis of angina. P 1 daily in the morning, increasing if necessary to max. 2 once daily. Q Not recommended. D Acute myocardial infarction, anaemia, head trauma, cerebral haemorrhage, severe hypotension, cerebrovascular insufficiency. Pregnancy, lactation. B Closed angle glaucoma. Hypothyroidism, malnutrition, severe renal or hepatic disease. C Alcohol. A Headache, dizziness, nausea, hypotension, collapse.
INDERAL LA
AstraZeneca
3MO Non-cardioselective b-antagonist. Propranolol (HCl) 160mg. 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 Angina. 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. 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.
ISOKET 0.1%
UCB
2N Nitrate. Isosorbide dinitrate 1mg/ml. Soln. Amps.10 x 10ml, A59.11; Bottles-50ml, A29.33; 100ml, A40.50.
2N ALSO ISOKET 0.05% Isosorbide dinitrate 0.5mg/ ml. 50ml, A15.69. S Severe or unstable angina pectoris. P 2-10mg/hour adjusting according to response. Max. 20mg/hour. Q Not recommended. D Uncompensated cardiac shock. Severe hypotension. Marked anaemia. Cerebral haemorrhage. A Headache, flushes, dizziness.
ISOMEL SR 60
Clonmel
2MO 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. C Alcohol, NA, acetylcholine, histamine, anti-hypertensives. A Headache, hypotension, dizziness, nausea.
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 ISOMONIT RETARD
ANGINA 2.2 Rowex
2MO Nitrate. Isosorbide mononitrate 60mg. White scored prolonged release tab. 30, A10.79. S Prophylaxis of angina. P 1 daily in the morning, increasing if necessary to max. 2 once daily. Q Not recommended. D Acute myocardial infarction with low filling pressure, circulatory failure, marked anaemia, head trauma, cerebral haemorrhage, severe hypotension, hypovolaemia, severe cerebrovascular insufficiency. B Closed angle glaucoma. Hypothyroidism, malnutrition, severe renal or hepatic disease. C Alcohol. A Headache, dizziness, nausea, hypotension, collapse.
ISOPTIN
Abbott
2MO Class I Ca++ antagonist. Verapamil (HCl) 40mg, 80mg, 120mg. White film-ctd tabs. 40mg-100, A3.54; 80mg-100, A7.07; 120mg-100, A10.60. 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.
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, A9.21; 10mg-28, A13.76. S Prophylaxis of angina pectoris associated with myocardial ischaemia. 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 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
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, METOCOR Rowex nefazodone, azole antifungals, digoxin, diltiazem, cyclosporine, tacrolimus, vincristine, antidiabetics, 3MO qinidine, cisapride. Avoid grapefruit juice. Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg- A Headache, facial reddening, palpitations, dizziness, leg oedema. 100, A3.50; 100mg-100, A6.50. S Angina. NIFTEN AstraZeneca P 50-100mg twice or three times daily. 3MO Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Cardioselective b-blocker/Class II Ca++ antagonist. Atenolol 50mg, sust.-release nifedipine 20mg. METOP Gerard Reddish brown cap. marked NIF-TEN. 28, A12.96. S Angina inadequately controlled on 3MO monotherapy. Cardioselective b-blocker. Metoprolol tartrate P 1 twice daily, if necessary prophylactic 50mg, 100mg. White tabs. Both marked ml and strength one side, G on reverse. 50mg-100, A3.50; nitrate therapy or additional nifedipine may be given. 100mg-100, A6.51. R Max. 1 twice daily. S Angina. Q Not recommended. P 50mg twice daily or 100mg daily. D Bradycardia, cardiogenic shock, Q Not recommended. hypotension, metabolic acidosis, severe peripheral D See 2.4, b-blockers Drug Presc. Notes. arterial circulatory disturbances, 2nd or 3rd degree MYOSTIN Teva heart block, sick sinus syndrome, untreated phaeochromocytoma, uncontrolled HF, pregnancy, 2MO lactation, severe aortic stenosis, marked renal Ca++ antagonist. Amlodipine 5mg, 10mg (as impairment (ccQ 15 ml/min). amlodipine maleate). White, round, tab. scored on B Controlled HF. Conduction defects or one side. 5mg-28, A8.28; 10mg-28, A12.38. poor cardiac reserve. Prinzmetal’s angina, 1st S Chronic stable and vasospastic angina degree heart block. May aggravate less severe pectoris as monotherapy or in combination with peripheral arterial circulatory disturbances. May other antianginal drugs. modify tachycardia of hypoglycaemia. May mask P 5mg once daily. If no sufficient effect within 2-4 weeks, may be increased to max. 10mg thyrotoxicosis. Will reduce heart rate. Do not discontinue abruptly in ischaemic heart disease. once daily. History of anaphylactic reaction to allergens. Q Under 18 years, not recommended. Asthmatics, diabetes, clinically significant liver D Severe hypotension, shock, HF after disease. Discontinue if ischaemic pain occurs. Use acute MI (during 1st 28 days), obstruction of in men in in vitro fertilisation. outflow-tract of left ventricle, unstable angina C Contra: Ca++ channel blockers with pectoris. Lactation, pregnancy (unless clearly negative inotropic effects (e.g. verapamil, necessary). diltiazem), rifampicin. Grapefruit juice, not B Low cardiac reserve, hepatic recommended. Caution: Other dihydropyridines, impairment, cardiac failure, elderly; caution. digitalis glycosides, clonidine, class 1 Driving/using machines. antiarrhythmics (e.g. disopyramide), amiodarone, C Caution: CYP3A4 inhibitors/inducers, sympathomimetics, prostaglandin synthetaseother antihypertensives incl. b-blockers. inhibiting drugs, anaesthetics, cimetidine. A Ankle swelling, headache, dizziness, A Oedema, dizziness, headache, GI fatigue, asthenia, palpitations, dyspnoea, disturbance, purpura, impotence, fatigue. abdominal pain, nausea, dyspepsia, flushing. 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.
NIFED
Rowex
2MO
NITRO-DUR
Schering-Plough
2MO
Nitrate. Glyceryl trinitrate 0.1mg/hour (20mg), 0.2mg/hour (40mg), 0.4mg/hour (80mg), 0.6mg/ hour (120mg). Transdermal patch. 0.1mg/hour-28, A14.05; 0.2mg/hour-28, A18.36; 0.4mg/hour-28, A20.32; 0.6mg/hour-28, A22.36. S Prophylaxis of angina pectoris. P Initially one 0.2mg/hour patch daily; 2MO titration to higher or lower doses may be ALSO NIFED RETARD Nifedipine 10mg, 20mg. Pink necessary. Patches are suitable for continuous or intermittent use. Patches may be applied for a 12 film-ctd modified-release tabs. 10mg-60, A8.08; hour period then removed to provide a nitrate20mg-100, A18.16. P Initially 10mg twelve hourly, increasing free interval, of 12 hours. Q Not recommended. if necessary to 40mg twelve hourly. D Severe hypotension, increased Q Not recommended. D Cardiogenic shock. unstable angina intracranial pressure, myocardial insufficiency.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
35
2.2 ANGINA
CIRCULATORY SYSTEM
B Acute myocardial infarction, CHF. Arterial hypoxemia due to anaemia. Closed angle glaucoma. C Vasodilating agents, ACE inhibitors, alcohol, anti-hypertensive agents, b-blockers, phenothiazines, Ca++ channel blocking agents. A Headache, dizziness, rash.
Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg. White, white, orange unscored film-ctd tabs. marked A25, A50, A100 resp. 25mg-30, A2.70; 50mg-30, A4.10; 100mg-30, A5.98. S Angina pectoris. P 100mg daily or 50mg twice daily. Renal impairment: See SPC. Q Not recommended. UCB D See 2.4, b-blockers Drug Presc. Notes.
NITROCINE 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.
PROCORALAN
Q Not recommended.
Servier D Severe renal impairment (ccQ30 ml/
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 sinus node function, immediately after a NITROLINGUAL SPRAY Merck Serono with stroke, congenital QT syndrome. Caution: Severe 2MO renal insufficiency (ccQ15ml/min), moderate Nitrate. Glyceryl trinitrate 0.4mg per metered hepatic impairment, HF NYHA I-II, asymptomatic dose. Pump spray. 200 dose, A5.07. LV dysfunction, retinitis pigmentosa, mild to moderate hypotension. Monitor for occurrence of S Treatment and prophylaxis of angina, atrial fibrillation. Contains lactose. incl. variant angina. Emergency treatment of C Contra: Strong CYP3A4 inhibitors (azole pulmonary oedema secondary to acute left antifungals, macrolide antibiotics, HIV protease ventricular (LV) failure until appropriate IV inhibitors, nefazodone). Avoid: Ca++ channel therapy. blockers (verapamil, diltiazem), QT prolonging P Hold canister to mouth, spray under agents. Caution: Moderate CYP3A4 inhibitors, tongue and close mouth immediately. Acute grapefruit juice, CYP3A4 inducers. attack: 1-2 doses; max. 3 per attack. ExerciseA Transient luminous phenomena induced angina: 1-2 doses before exertion. LV (phosphenes), blurred vision (discontinue if failure: 2 doses as quickly as possible in upright unexpected deterioration). Bradycardia, AV 1st position, repeated as necessary. degree block, ventricular extrasystoles. Headache, Q Not recommended. dizziness. D Hypotensive shock, severe anaemia, cerebral haemorrhage and brain trauma, mitral RANEXA A. Menarini stenosis, arterial hypoxaemia, uncorrected hypovolaemia and angina caused by hypertrophic ; N O obstructive cardiomyopathy. Pregnancy, lactation Antianginal. Ranolazine 375mg, 500mg, 750mg. (unless benefi outweighs risk). Resp. pale blue, light orange or pale green ovalC Contra: Phosphodiesterase inhibitors for shaped prolonged-release tabs engraved with CVT erectile dysfunction. and strength on one side. 375mg-60, A53.37; A Headache, somnolence, dizziness, 500mg-60, A53.37; 750mg-60, A53.37. tachycardia, hypotension, orthostatic hypotension. S Add-on therapy for symptomatic treatment of patients with stable angina pectoris NORTENOLOL Tillomed inadequately controlled or intolerant to first-line 3MO antianginal therapies (b-blockers and/or Ca++
36
antagonists). P Initially 375mg twice daily. After 2-4 weeks, titrate to 500mg twice daily. May be further titrated to 750mg max twice daily. Downtitration to 500mg or 375mg twice daily may be required if adverse events occur. Moderate hepatic impairment, mild to moderate renal impairment, CHF, low weight, elderly: Caution during titration.
min). Moderate/severe hepatic impairment. Pregnancy (unless clearly necessary), lactation. B Caution when prescribing or uptitrating: Patients at increased exposure risk (mild hepatic impairment, mild to moderate renal impairment (cc, 30-80ml/min), elderly, low weight (R60 kg), moderate to severe CHF (NYHA Class III窶的V)), if several factors are combined monitor adverse events frequently, reduce dose, discontinue treatment if needed; increased exposure risk in patients lacking CYP2D6 activity; congenital or family history of long QT syndrome, known acquired QT interval prolongation. Check renal function regularly. Contains lactose, E110, E102. C Contra: Potent CYP3A4 inhibitors, Class Ia or Class III antiarrhythmics other than amiodarone. Avoid Ranexa initiation: Inducers of CYP3A4. Careful titration (down titration may be required): Moderately potent CYP3A4 inhibitors, Pgp inhibitors. Caution: CYP2D6 inhibitors, CYP2B6 substrates, digoxin (monitor levels during initiation and termination of Ranexa), drugs known to prolong the QTc interval such as certain antihistamines, certain antiarrhythmics, erythromycin and TCAs. A Dizziness, headache, GI disorders, asthenia.
RUSTIN
Helsinn Birex
2MO Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine besilate). White, round, slightly arched tabs. marked with AB 5 or AB 10 resp. 10mg tab. is scored. 5mg-28, A7.34; 10mg-28, A10.97. S Prophylaxis of angina pectoris associated with MI. P 5mg once daily, may be increased to max. dose of 10mg daily depending on response. Q Not recommended. D Lactation, pregnancy (unless clearly necessary). B Heart failure, hepatic impairment. A Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, oedema, fatigue.
SELECTOL
sanofi-aventis
3MO Vasodilating cardioselective b-blocker. Celiprolol (HCl) 200mg, 400mg. 200mg yellow heart-shaped tab.; 400mg white heart-shaped tab. Both marked with logo one side and 200 or 400 on reverse. 200mg-28 (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), A15.11. S Angina pectoris. 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.
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 SOPROL
ANGINA 2.2 Helsinn Birex
3MO Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. White film-ctd tabs. marked BISOPROLOL and tab. strength on one side. 5mg28, A5.75;10mg-28, A6.43. S Angina pectoris. P Usually 10mg once daily; max. 20mg 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. C See 2.4, b-blockers Drug Presc. Notes. Avoid: Floctafenine, sultopride. Caution: Rifampicin, baclofen, iodated contrast products, mefloquine, corticosteroids.
SORMON
Gerard
2MO Nitrate. Isosorbide mononitrate 60mg. Yellow, elliptical, film-ctd tab. with breaklines, marked IM 60 on one side. 28, A10.24. S Prophylaxis of angina. P 1 daily in the morning, increasing if necessary to max. 2 once daily. Q Not recommended. D Acute myocardial infarction, anaemia, head trauma, cerebral haemorrhage, severe hypotension, cerebrovascular insufficiency. Pregnancy, lactation. B Closed angle glaucoma. Hypothyroidism, malnutrition, severe renal or hepatic disease. C Alcohol. A Headache, dizziness, nausea, hypotension, collapse.
SOTACOR
BMS
3MO Non-cardioselective b-blocker. Sotalol (HCl) 80mg, 160mg. Both white tabs. scored on one side and tab. strength marked on other side. 80mg-28, A2.67; 160mg-28, A5.26. S Prevention of myocardial infarction. Cardiac arrhythmias. Angina. Hypertension. P Reinfarction: 320mg once daily, starting 5-14 days after infarction. Arrhythmias: Initial dose 80mg either singly or as 2 divided doses. Allow 2-3 days between increments. Most respond to dose of 160-320mg admin. in 2 divided doses at 12 hr intervals. In renal impairment; cc q60ml/min: Normal dose; cc 30-60ml/min: Half normal dose; cc 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 failure. B Caution: Pre-existing arrhythmias, QT interval q 550msec. Electrolyte disturbances esp. hypokalaemia or hypomagnesaemia. Caution: Left ventricular dysfunction, recent MI. See b-blockers Prescribing Notes. See 2.4, b-blockers Drug Presc. Notes.
Liver damage. Contains sodium benzoate. 2mg three times daily increasing strength and frequency if necessary. Place tab. high up between TRANSIDERM-NITRO Novartis the upper lip and gum and allow to dissolve. Q Not recommended. 2MO A Headache, flushes. Nitrate. Glyceryl trinitrate 5mg, 10mg or 15mg per 24 hours. Transdermal patches. 5mg-28, A17.46; TENORMIN AstraZeneca 10mg-28, A19.17; 15mg-30, A19.94. 3MO S Prophylaxis of angina pectoris, as monotherapy or in combination with other antiCardioselective b-blocker. Atenolol 25mg, 50mg, anginal agents. Apply to non-hairy area of lateral 100mg. White, white, orange biconvex film-ctd chest wall, remove and replace with new patch tabs. marked Tenormin 25, Tenormin 50, and Tenormin respectively. 100mg bisected on reverse. using a different site daily. A A P Commence with 5mg patch, increasing 25mg-28, 3.28; 50mg-28, 4.24; 100mg-28, A5.39. to 10mg or 15mg, max. 2 x 10mg if necessary. A nitrate free interval of 8-12 hours (usually at S Cardiac arrhythmias. Early intervention night) during each 24 hour period is in acute MI. Angina pectoris. Hypertension. recommended. P 50-100mg daily. Q Not recommended. Q Not recommended. D Severe hypotension or hypovolaemia. D See 2.4, b-blockers Drug Presc. Notes. Raised intracranial pressure. Myocardial TILDIEM LA Sanofi insufficiency due to obstruction. B Recent myocardial infarction or acute 2MO HF. Arterial hypoxemia due to anaemia. Closed Class III Ca++ antagonist. Diltiazem (HCl) 200mg angle glaucoma. pink/grey cap.; 300mg white/yellow cap.; A Headache, rash, dizziness. containing immediate release and sust.-release pellets. 200mg-28, A11.87; 300mg-28, A12.95. TRANTALOL Pinewood S Angina. P Initially 1 x 300mg once daily, increasing 3 M O if necessary to 2 x 200mg once daily, or then 1 x Cardioselective b-blocker. Atenolol 25mg, 50mg, 200mg plus 1 x 300mg daily. 100mg. White tabs. 25mg: Circular, flat, scored on R Initially 1 x 200mg daily increasing to 1 one side. 50mg and 100mg: Biconvex, film-ctd, x 300mg once daily. marked 1U1 and 2U1 resp. 25mg-30, A2.54; 50mgQ Not recommended. 30, A3.90; 100mg-30, A5.50. S Angina pectoris. 2MO P 100mg once daily or 50mg twice daily. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, Renal failure: Reduce dose (see SPC). 120mg. Off-white sust.-release tabs. 90mg-56, Q Not recommended. A13.66; 120mg-56, A15.19. D See 2.4, b-blockers Drug Presc. Notes. P 90-120mg twice daily. Max. 480mg B Caution: Patients with poor cardiac daily. reserve. Will reduce heart rate. Contains lactose Q Not recommended. (50mg and 100mg). See 2.4, b-blockers Drug Presc. 2MO Notes. ALSO TILDIEM Diltiazem (HCl) 60mg. Off-white C See 2.4, b-blockers Drug Presc. Notes. tab. coded TILDIEM 60. 90, A15.48. A Precipitation of atrioventricular block, P Usually 60mg three times daily, purpura, thrombocytopenia, impotence. See 2.4, bincreasing if necessary to max. 480mg daily in blockers Drug Presc. Notes. divided doses. R Initially 60mg twice daily, increasing to VASTAREL Servier 90-120mg twice daily. 2MO Q Not recommended. D Pregnancy. Sick sinus syndrome; 2nd or Cellular anti-ischaemic. Trimetazidine (diHCl) 3rd degree AV block; marked bradycardia. 20mg. Red film-ctd tab. 90, A12.72. B Observe patients with mild bradycardia S All grades of angina and as an adjunct or a prolonged PR interval. Measure heart rate in the treatment of certain ischaemic disorders regularly in the elderly and in patients with affecting chorioretinal tissue and cochleohepatic or renal impairment. vestibular structures. C b -blockers, digitalis. P 1 three times daily with meals. A Bradycardia, 1st degree AV block, ankle Q Not recommended. oedema, nausea, headache, rash. B Closed angle glaucoma. Pregnancy, lactation. TRANDATE UCB C MAOIs.
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 SUSCARD BUCCAL Forest pregnancy and for long term management of 2MO hypertension following acute myocardial Nitrate. Glyceryl trinitrate 2mg, 3mg, 5mg. White infarction. Angina. sust.-release tabs. marked with tab. strength. 2mg- P Initially 100mg twice daily with food 100, A20.19; 3mg-100, A28.29; 5mg-100, A39.67. increasing if necessary at fouteen day intervals. Max. 2.4g daily in three or four divided doses. S Treatment and prophylaxis of angina Q Not recommended. pectoris. P Acute: initially 2mg as required. Chronic: B See 2.4, b-blockers Drug Presc. Notes.
VERAMIL
Orion
2MO Class I Ca++ antagonist. Verapamil chlor. 40mg, 80mg, 120mg. White film-ctd tabs. coded VL-40, VL-80 and VL-120. 40mg-100, A5.17; 80mg-100, A8.67; 120mg-100, A11.56. S Chronic angina pectoris, both stable and unstable. Vasospastic (Prinzmetal variant) angina. P 120mg three to four times daily. Angina of effort, 80mg three times daily may be sufficient. Severe liver dysfunction: Use 1/3 dose. D Severe left ventricular dysfunction. Severe hypotension, cardiogenic shock. 2nd or 3rd
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
37
2.3 OEDEMA
CIRCULATORY SYSTEM
A9.53; 100, A34.02. S Hypertension, control of oedema in congestive heart failure. P Hypertension, 25-100mg spironolactone daily with breakfast. CHF, initially 100mg spironolactone daily with food; then adjust range 25-100mg daily. Continue at least 2 weeks for adequate response. Q 1.5-3mg/kg spironolactone daily in divided doses. D Anuria, acute renal insufficiency, severe or progessive renal failure, hyperkalaemia, precoma associated with severe liver disease, Addison’s disease, significant hypercalcemia. Neonates and young infants. Lactation. B Monitor serum electrolystes periodically. May induce hyper/hypokalaemia, hyponatremia, hyperlipidaemia, hyperglycaemia, increases in blood urea, hyperuricaemia; caution in elderly, obstruction of the urinary tract, hepatic or renal impairment, diabetes, gout. Pregnancy. 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, A A 120mg-30, 5.43; 240mg-30, 10.85. 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. B Monitor BP at regular intervals K+sparing. Spironolactone 25mg, 50mg, 100mg. particularly in 1st degree AV block, hypotension, Round, biconvex tabs. with peppermint odour bradycardia, atrial fibrillation/flutter or marked SEARLE/39, SEARLE/916 or SEARLE/134 simultaneous pre-excitation syndrome. Impaired resp. 25mg, 100mg: Buff coloured. 50mg: White. hepatic function. Pregnancy, lactation. 25mg-100, A10.56; 50mg-100, A21.10; 100mg-28, C Anti-arrhythmic drugs, b-blockers, A11.82; 100, A42.19. inhalation anaesthetics, quinidine, digoxin, S Oedema associated wit CHF, lithium, carbamazepine, cimetidine, ranitidine, hypertension, hepatic cirrhosis, malignant ascites, grapefruit juice. nephrotic syndrome, primary aldosteronism. A Constipation, dizziness, giddiness, P CHF: 100mg daily increasing if necessary nervousness, headaches, fatigue, flush, paresthesia. to 200mg daily; maintenance, 75-200mg daily. Hypertension: 50-100mg daily increasing if VERISOP Gerard necessary at two weekly intervals up to 200mg 2MO daily. All with food. Other conditions, see SPC. 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 A progressive/ severe renal impairment, one side, G on reverse. 40mg-100, 3.53; 80mghyperkalaemia, precoma associated with severe 100, A5.16; 120mg-100, A10.59. liver disease. Lactation. S Angina. B Monitor serum electrolytes periodically. P 40-120mg three times daily. May induce hyperkalaemia, hyponatremia, Q Not recommended. increases in blood urea; caution in elderly, D Cardiogenic shock. 2nd or 3rd degree obstruction of the urinary tract, hepatic or renal AV block. Severe bradycardia. Uncompensated impairment. Pregnancy. cardiac failure. Sick sinus syndrome. C Contra: K+suppl., K+sparing diuretics. B 1st degree AV block. Poor cardiac Avoid carbenoxolone, lithium. Caution: reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. antihypertensives, diuretics, digitalis, cardiac glycosides, NSAIDs, anaesthesia, ammonium Bradycardia. chloride, colestyramine, digoxin, aspirin, C b-blockers, quinidine or digoxin. indometacin, mefenamic acid, antipyrine. A Constipation, headache, flushes. A GI upset, drowsiness, headache, 2.3 OEDEMA confusion, leg cramps, skin disorders, alopecia. Gynaecomastia, menstrual irregularities, breast ALDACTIDE Pharmacia pain, impotence, change in libido. Malaise, drug fever, lethargy. 5NO K+sparing/thiazide. Spironolactone, ARELIX sanofi-aventis hydroflumethiazide 25mg/25mg, 50mg/50mg. 5MO Circular, biconvex, buff coloured, film-ctd tab. with peppermint odour marked SEARLE 101 and Loop diuretic. Piretanide 6mg. Yellowish-white, SEARLE 180 resp. 25mg-100, A18.00; 50mg-28, oblong scored tab. marked with logo on one side
degree AV block. Marked bradycardia. Sick sinus syndrome. CHF incl. including uncompensated HF. Lactation. B 1st degree AV block reported. Hypertrophic cardiomyopathy, elderly, attenuated neuromuscular transmission. Mild to moderate HF (control with digitalis and diuretics). Porphyria (unsafe). Hepatic impairment (monitor during long-term therapy). Contains lactose. Pregnancy. C Grapefruit juice, digitalis intoxication, IV b-blockers (contra). Colchicine, cisapride (avoid). a/ b-blockers, CYP3A4 inhibitors/substrates, antiarrhythmics, CCBs, cardiac glycosides, theophylline, imipramine, glyburide, doxorubicin, paclitaxel, tamoxifen, cimetidine, statins, almotriptan, halothane, dantrolene, Ca++ salts, alcohol, lithium, timolol eye drop, quinidine, antihypertensives. A Constipation, headache, dizziness, fatigue, rash, bradycardia, hypotension, cardiac insufficiency, swelling of ankles.
38
and ARE on reverse. 20-A4.32. S Fluid retention. P Initially, 6mg daily, adjusted to max. 30mg. R Initially, 3mg daily. Q Not recommended. D Severe electrolyte imbalance, hypovolaemia, hypotension, hypokalaemia, precoma associated with hepatic cirrhosis, advanced renal failure, digitalis intoxication. Pregnancy, lactation. B Impaired micturition or prostatic hypertrophy. Severely impaired renal function (monitor serum electrolytes). C Aminoglycoside, cephalosporin, corticosteroids, carbenoxolone, laxatives, antihypertensive agents, cardiac glycosides, nondepolarising muscle relaxants, drugs used in treatment of gout, lithium, NSAIDs.
BURINEX
LEO Pharma
5MO Loop diuretic. Bumetanide 1mg, 5mg. White scored tabs. 1mg marked 133 and lion logo; 5mg marked with tab. strength. Scoreline only to facilitate swallowing; not to divide into equal doses. 1mg-28, A1.98; 5mg-28, A9.03. S Oedema associated with congestive heart failure, hepatic ascites and renal disease, incl. the nephrotic syndrome. P Usually 0.5-2mg as a single or divided dose, adjust according to patients response. Q Not recommended. D Precomatose states associated with liver cirrhosis. Electrolyte depletion, anuria. B K+suppl. may be required. Renal or hepatic impairment. Diabetes. Pregnancy, lactation. Prostatic hypertrophy or impaired micturition. Elderly. Use with nephrotoxic drugs. C Lithium, digitalis, antihypertensives, aminoglycosides, cephaloridine. A Hypokalaemia, GI discomfort, rash, cramps, thrombocytopenia, gynaecomastia, ototoxicity, gout, leucopenia, hyperuricaemia, hyperglycaemia, bone marrow depression, nausea, vomiting, dizziness, muscle tenderness.
CENTYL
LEO Pharma
5MO Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, circular, flat, slightly bevelled tabs. 2.5mg-500, A21.25; 5mg-100, A6.38; 500, A31.88. S Oedema (cardiac, renal, hepatic origin). P Initially 2.5-10mg every morning; 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 hypotension, GI disorders. Electrolyte disturbances (long term use).
CENTYL K
LEO Pharma
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
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, A15.11. S Oedema (cardiac, renal or hepatic origin). P Initially 1-4 every morning; maintenance, 1-2 daily. 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.
DIAMOX
Goldshield
5MO Carbonic anhydrase inhibitor. Acetazolamide 250mg. White scored tab. marked LEDERLE 4395. 112, A15.56.
5NO ALSO DIAMOX PARENTERAL Acetazolamide Na+ 500mg. Powder in vial. 1, A20.40. S Congestive heart failure, drug-induced oedema, pre-menstrual tension. P Initially 250-375mg once daily in the morning or on alternate days. Pre-menstrual oedema, 125-375mg as a single daily dose beginning 5-10days before menstruation. See SPC. Q Not recommended. D Chronic closed angle glaucoma. Renal hyperchloraemic acidosis. Adrenal insufficiency. Na+ or K+ depletion. B Gout. Diabetes. Pregnancy. K+suppl. may be required. Monitor fluid, electrolytes and blood. C Folic acid antagonists, hypoglycaemics, oral anticoagulants. A Flushing, thirst, headache, drowsiness, polyuria, paraesthesia, blood dyscrasias, excitement, rash.
DYAZIDE
Goldshield
5MO K+sparing/thiazide. Triamterene 50mg, HCTZ 25mg. 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.
(not recommended), pregnancy. C Cardiac glycosides, hypotensive agents, non-depolarising muscle relaxants, lithium (adjust FRUCO Teva dosage). Effects of antidiabetics, pressor amines, salicylates, theophylline may also be affected. 5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) Cephaloridine or aminoglycosides (risk of aggravated toxicity). NSAIDs may attenuate 5mg. Orange scored tab. marked FRU CO. 28, furosemide action. Reduce or stop furosemide A2.78; 56, A5.43. before treatment with ACE inhibitors. S Congestive cardiac failure, nephrotic Glucocorticoids, laxatives (risk of increased K+ loss). syndrome, corticosteroid therapy, oestrogen A Fluid and/or electrolyte imbalance, therapy. Ascites in association with cirrhosis. hypotension, reduced serum Ca++ levels, transient P 1-2 in the morning. increase of serum cholesterol and triglyceride Q Not recommended. D Precomatose states associated with liver levels, hyperuricaemia, aggravation of pre-existing cirrhosis. Progressive renal failure. Hyperkalaemia. metabolic alkalosis. Nausea, gastric upset, malaise, rashes, photosensitivity, diarrhoea, headache, B Hepatic or renal impairment. Elderly. muscle cramps, tinnitus, gout, ototoxicity. Diabetes, acidosis. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. LASIX sanofi-aventis C K+suppl., K+sparing diuretics, lithium, 5MO digitalis, aminoglycosides, cephalosporins, antihypertensives, NSAIDs, ACE inhibitors, nonLoop diuretic. Furosemide 20mg, 40mg. White polarising muscle relaxants, hypoglycaemics. round tab. marked DL or DLI resp. on one side A Malaise, GI upset, rash, blood dyscrasias. and Hoechst on the other. 20mg-60, A1.37; 40mg100, A3.31. FRUMIL sanofi-aventis S Fluid retention. Mild to moderate hypertension. 5MO Loop/K+sparing. Furosemide 40mg, amiloride (HCl) P 20-80mg as single dose daily or on alternate days. 5mg. Orange scored tab. marked FRUMIL. 28, Q 1-3mg/kg daily. A3.09; 56, A6.04. 5 N S Oedema associated with cardiac failure, ALSO LASIX INJECTION Furosemide 20mg/2ml. 5, hepatic and renal disease. A1.49. P 1-2 in the morning. P Initially 20-50mg as single dose IM or R Use Frumil LS. slow IV. See SPC. Q Not recommended. Q 0.5-1.5mg/kg daily. 5MO D Precomatose and comatose states ALSO FRUMIL LS Furosemide 20mg, amiloride associated with hepatic encephalopathy. (HCl) 2.5mg. Orange tab. marked LS. 28 (Cal/Pk), Hypovolaemia, dehydration, anuria, renal failure, A3.88. severe hypokalaemia, severe hyponatraemia. P 1 in the morning. Pregnancy, lactation. Q Not recommended. D Precomatose states associated with liver B Hepatorenal syndrome. Hypotension. cirrhosis. Progressive renal failure. Hyperkalaemia. Premature infants (increased risk of persistence of patent ductus arteriosus). Hypoproteinaemia. B Hepatic or renal impairment. Diabetes, Acute porphyria. Glucose intolerance. Gout. acidosis. Prostatic hypertrophy or impaired Diabetes. Prostatic hypertrophy or impaired micturition. Gout. Pregnancy, lactation. micurition. Monitor electrolytes and creatinine. C K+suppl., K+sparing diuretics, lithium, Tabs. contain lactose. digitalis, aminoglycosides, cephalosporins, C Lithium, cyclosporin, radio-contrast antihypertensives, NSAIDs, ACE inhibitors. A Malaise, GI upset, rash, blood dyscrasias. therapy, aminoglycosides, nephrotoxic antibiotics, cephalosporins, sucralfate, corticosteroids, FRUSIDE Pinewood corticotrophin, amphotericin B, ACE-inhibitors, chloral hydrate, antihypertensives, diuretics, other 5MO hypotensive agents, NSAIDs, carbamazepine, Loop diuretic. Furosemide 40mg. White, flat, aminoglutethimide, carbenoxolone, liquorice, B2 bevel-edged tabs., engraved 2B2 with double sympathomimetics, laxatives, reboxetine, cisplatin, breakline on reverse. 100, A3.12; 500, A11.50. cardiac glycosides, digitalis preparations, drugs S Fluid retention, oedema of cardiac, inducing QT interval prolongation syndrome, hepatic or renal origin, pulmonary oedema and phenytoin, metolazone, probenecid, methotrexate, mild or moderate hypertension. antidiabetic drugs, BP increasing P Initially 40mg daily, adjust as required sympathomimetics, curare type muscle relaxants, from 20mg on alternate days to 120mg daily. theophylline, risperidone. R Titrate dosage as required (slower A Increase in cholesterol. Thromboses, elimination). vasculitis. GI upset. Hearing disorders, tinnitus. Q 1-3 mg/kg body weight daily. Skin disorders. Severe anaphylactic /anaphylactoid D Hypokalaemia or other electrolyte reactions. Paraesthesiae. Blood and lymphatic deficiency, anuria, pre-coma associated with liver system disorders. Inj. site reactions, fever. cirrhosis, digitalis intoxication. Hypersensitivity to A Nausea, diarrhoea, cramps, weakness, headache, dry mouth, rash, blood dyscrasias.
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
METOPIRONE
Novartis
2MO Aldosterone inhibitor. Metyrapone 250mg. Cream cap. coded CIBA and LN. 50, A14.42. S With glucocorticoids to treat resistant oedema due to increased aldosterone secretion. Diagnosis and management of Cushing’s
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
39
2.4 HYPERTENSION
CIRCULATORY SYSTEM
syndrome; see SPC. P Resistant oedema, 3g daily in divided doses. Cushing’s syndrome, see SPC. Q 15mg/kg every 4 hours; min. 250mg every 4 hours. D Primary adrenocortical insufficiency. Pregnancy, lactation. B Hypopituitarism. A Nausea, vomiting, hypotension, allergic reactions, abdominal pain, sedation, dizziness, headache, hypoadrenalism, hirsutism.
Hepatic impairment, alcoholic cyrrhosis. Renal insufficiency; monitor renal function before and during therapy. Contains lactose. C Avoid tetracyclines. Caution: b-blockers, methyldopa, diuretics, lithium, agents increasing serum K+, antidiabetics, surgery/anaesthesia. A Pharyngitis, insomnia, hyperkalaemia, paraesthesia, dyspnoea, abdominal pains, back pain, myalgia, asthenia.
may occur, paraesthesias of the hands, serum sickness, cough, bronchospasm and lymphadenopathy.
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 ACCURETIC Parke-Davis other. 5/5mg, rod-shaped; 5/10mg, square-shaped; 5MO 10/5mg, triangular-shaped; 10/10mg, round. 5/ MODURET 25 MSD 5mg-30, A25.66; 5/10mg-30, A31.13; 10/5mg-30, ACE inhibitor/thiazide diuretic. Quinapril 20mg, 5MO A34.41; 10/10mg-30, A39.88. HCTZ 12.5mg. Pink, triangular, biconvex, film-ctd S Substitution therapy for treatment of K+sparing/thiazide diuretic. Amiloride (HCl) 2.5mg, tab. with a scoreline on 1 side, plain on reverse. 28 (Cal/Pk), A12.56. essential hypertension and/or stable coronary HCTZ 25mg. Off-white diamond-shaped scored A artery disease, in patients already controlled with tab. coded 923. 28, 2.17. S Hypertension. perindopril and amlodipine given concurrently at P Initially 10/12.5mg, increasing to 20/ S Hypertension. same dose level. 12.5mg as necessary. P 1 tab. once daily. In some cases a P 1 tab./day as single dose, preferably the R As low as possible. starting dose of half a tab. once daily. morning before a meal. Not suitable for initial Q Not recommended. Q Not recommended. therapy. D Hereditary/idiopathic angioneurotic D Hyperkalaemia. Progressive or severe oedema, history of angioneurotic oedema relating Q Not recommended. renal failure. Pregnancy, lactation. D Hypersensitivity to ACE inhibitors and B Diabetes, acidosis, gout, renal or hepatic to previous treatment with an ACE inhibitor, impairment. dihydropyridines. History of angioedema anuria, hyperkalaemia, subaortic stenosis, left C K+suppl., K+sparing diuretics, digitalis, associated with previous ACE inhibitor therapy. ventricular outflow tract obstruction, renal lithium, antihypertensives. ACE inhibitors. Hereditary or idiopathic angioedema. Severe insufficiency, hypersensitivity to quinapril, A Rash. photosensitivity, blood dyscrasias, thiazides or any sulphonamide-derived drug. hypotension. Shock, including cardiogenic shock. gout. Obstruction of the outflow-tract of the left Pregnancy, lactation. ventricle (e.g. high grade aortic stenosis). Unstable B Renal or liver impairment, severe CHF, NATRILIX SR Servier renal artery stenosis, haemodialysis, diabetes, angina pectoris (excluding Prinzmetal’s angina). HF anaesthesia, hypotension, anaphylactoid reactions, after acute MI (during first 28 days). Pregnancy, 5MO hypoglycaemia and diabetes. History of allergy or lactation. Antihypertensive diuretic. Indapamide B May rarely occur: Hypersensitivity, bronchial asthma. Monitor renal function. hemihydrate 1.5mg. White sust.-release coated angioedema (discontinue if occurs) or C Tetracyclines, K+ sparing diuretics, K+ tab. 30, A5.41. suppl., lithium, corticosteroids, NSAIDs, anaphylactoid reactions during LDL-apheresis and S Hypertension. tubocurarine, ACTH, NA. desensitisation, neutropenia, agranulocytosis, P 1 daily. A Headache, dizziness, rhinitis, coughing, thrombocytopenia, anaemia, hepatic failure, Q Not recommended. fatigue, myalgia, GI upset, chest pain, insomnia, symptomatic hypotension (in patients with salt or D Severe renal failure, hepatic chest infections. Sensitivity reactions, angioedema. volume depletion), hyperkaliemia. Caution: Aortic encephalopathy or severe hepatic failure, and mitral valve stenosis, hypertrophic hypokalaemia. ACEOMEL Clonmel cardiomyopathy, heart failure, collagen vascular B Pregnancy, lactation. Monitor K+ and disease, immunosuppressant therapy, treatment uric acid serum levels. Monitor blood glucose in 2MO with allopurinol or procainamide, hepatic diabetics. ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. C Lithium, agents causing hypokalaemia, White scored tabs. marked with logo one side and impairment. Renal impairment: Adjust dosage according to individual dose titration with the baclofen. coded 344, 345 or 346 on reverse. 12.5mg-56, monocomponents. Discontinue 1 day prior to A Hypokalaemia, fatigue, orthostatic A7.73; 25mg-56, A8.69; 50mg-56, A14.80. surgery. Closely monitor glycaemic control in hypotension, allergic manifestations. S Hypertension. P Initially 25mg daily and titrate according diabetic patients. Contains lactose. 2.4 HYPERTENSION C Not recommended: K+-sparing diuretics, to response at 2-4 week intervals. Usual max. + + 100mg in single or divided doses. Add a diuretic if K supplements, K -containing salt substitutes, ACCUPRO Pfizer lithium, estramustine, dantrolene. Caution: required. Elderly and those patients already on NSAIDs, antidiabetics (insulin, hypoglycaemic 2MO diuretic therapy, initially 25mg once daily and sulphonamides), CYP3A4 inducers / inhibitors, ACE inhibitor. Quinapril 5mg, 10mg, 20mg, 40mg. titrate according to response. Renal impairment, baclofen, corticosteroids, tetracosactide, alpha5mg, 10mg, 20mg: Elliptical, triangular or round initiate at a lower dose, 12.5mg daily and titrate blockers, amifostine, TCAs, antipsychotics, resp., brown film-ctd tabs. All marked with tab. according to response. anaesthetics. Diuretics, sympathomimetics, gold, bstrength. 40mg: Reddish-brown, oval biconvex Q Contact manufacturer. blockers, vasodilatators. film-ctd tab. with debossing 40 on one side and D Aortic stenosis. See SPC. A Somnolence, dizziness, headache, PD 535 on reverse. 5mg-28, A8.38; 10mg-28, B With renal impairment, collagen paresthaesia, vertigo, visual disturbances, tinnitus, A9.57; 20mg-28, A9.81; 40mg-28, A10.05. vascular disease, immunosuppressant therapy, palpitations, flushing, hypotension, GI S All grades of essential hypertension as monitor white cell count and urinary protein. disturbances, pruritus, rash, muscle cramps, monotherapy or in combination with diuretics. Anaesthesia. oedema, peripheral oedema, fatigue, asthenia, dry P Initially 10mg once daily adjusting C K+sparing diuretics, K+suppl., NSAIDs, vasodilators, clonidine, allopurinol, procainamide, cough. according to response; usual maintenance, 2040mg daily as single or in two divided doses; max. probenecid, immunosuppressants, lithium. ADALAT LA Bayer Schering A Rash, loss of taste, neutropenia, 80mg daily. Initial dose with concurrent diuretics, 2MO thrombocytopenia, proteinuria, hypotension, 5mg once daily. Class II Ca++ antagonist. Nifedipine 20mg, 30mg, angioedema. Anaemia, elevated blood urea and R Initially 5mg once daily. creatinine, elevated serum potassium and acidosis, 60mg. Pink modified-release tab. marked ADALAT Q 6-12 years, not recommended. 20, ADALAT 30 and ADALAT 60. 20mg-28, A9.21; D Subaortic stenosis, history of ACE inh. - tachycardia, pruritis, flushing, vesicular or bullous 30mg-28, A11.85; 60mg-28, A17.61. rash and photosensitivity, elevation of liver related angioneurotic oedema. Pregnancy, enzymes has been noted in a few patients, rare lactation. S Mild to moderate hypertension. cases of hepatocellular injury and cholestatic B Hypoglycaemia, neutropenia/ P Initially 20mg once daily in the agranulocytosis, anaphylactoid reactions. Caution: jaundice. Gastric irritation and abdominal pain morning. Increase if necessary up to max. 90mg
40
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
white cap.; 120mg brown/white cap.; 180mg brown/white cap. All cont. -release caps. marked with strength. 90mg-56, A12.80; 120mg-56, A14.21; 180mg-56, A21.32. 2MO P Initially 90mg twice daily. Increase ALSO ADALAT RETARD Nifedipine 10mg, 20mg. gradually to 120mg or 180mg twice daily as Pink tab. marked A10 and 1U on one side resp. required. and Bayer cross on reverse. 10mg-56, A9.72; R Start at lowest level of 90mg twice A 20mg-56, 11.87. P Initially 10mg twelve hourly adjusting to daily; carefully titrate as required. Q Not recommended. response, increasing to 40mg every 12 hours. D Pregnancy, lactation. Sick sinus Q Not recommended. syndrome, 2nd or 3rd degree AV block, marked 2MO bradycardia, decompensated cardiac failure. ALSO ADALAT Nifedipine 5mg, 10mg. Orange, B Mild bradycardia, prolonged PR interval. gelatin ovoid caps. containing yellow fluid. 5mgMeasure heart rate regularly in elderly and in 90, A6.32; 10mg-90, A8.02. patients with hepatic or renal impairment. P Initially 5mg eight hourly adjusted Diabetes. according to response, increasing to max. 20mg C b-blockers, digoxin, cimetidine, every 8 hrs. diazepam, antihypertensives, anaesthetics, Q Not recommended. dantrolene inf. D Women of child-bearing potential, lactation, cardiogenic shock, aortic stenosis. Acute A Anorexia, nausea, bradycardia, oedema, angina attacks, unstable angina pectoris, during or rash, flushing, fatigue, AV block. within one month of MI. Adalat LA only: Hepatic Pinewood impairment, history of GI obstruction, IBD, Crohn’s AMLID 2MO disease. B Poor cardiac reserve, HF, hepatic Ca++ antagonist. Amlodipine 5mg, 10mg (as impairment, severe hypotension. Diabetes, dialysis. amlodipine maleate). White round biconvex tab. Severe GI narrowing. Elderly. Driving/using 10mg tab. scored on both sides. 5mg-28, A9.19; machines. Postural hypertension, syncope, 10mg-28, A13.70. tachycardia reported. S Essential hypertension. C Contra: Rifampicin. Avoid grapefruit P 5mg once daily with water. If no effect juice. Caution: Antihypertensive agents, within 2-4 weeks, may be increased to max. 10mg cimetidine, quinidine, digoxin, phenytoin, once daily. diltiazem, cisapride, quinupristin/dalfopristin, Q Under 12 years, not recommended. CYP3A4 inhibitors. D Severe hypotension, shock, HF after A Headache, vasodilatation, palpitation, acute MI (during 1st 28 days), obstruction of nausea, dizziness, oedema. Lethargy, asthenia, outflow tract of left ventricle (e.g. high grade constipation. aortic stenosis), unstable angina pectoris. Pregnancy (unless essential), lactation. ADIZEM XL CAPSULES Mundipharma B Low cardiac reserve, cardiac failure, hepatic impairment, elderly. Contains lactose. 2MO C Caution: CYP3A4 inhibitors/ inducers, Class III Ca++ antagonist. Diltiazem (HCl) 120mg other antihypertensives incl. b-blockers. pink/blue cap.; 180mg pink/blue cap.; 240mg red/ A Ankle swelling. Headache, fatigue, blue cap.; 300mg maroon/blue cap. All cont.dizziness, asthenia, palpitations, flushing, nausea, release caps. marked with DCR and strength. dyspepsia, abdominal pain. 120mg-28, A8.40; 180mg-28, A12.45; 240mg-28 A16.05; 300mg-28, A12.42. AMLIST Gerard S Mild to moderate hypertension. 2MO P Initially 240mg once daily adjusting according to response. Caps. should be swallowed Ca++ antagonist. Amlodipine 5mg, 10mg (as whole. amlodipine maleate). White round tab. 10mg with R Initially 120mg once daily; carefully break score on both sides. 5mg-28, A9.20; 10mgtitrate as required. 28, A13.75. Q Not recommended. S Essential hypertension. 2MO P 5mg once daily with water. If no effect ALSO ADIZEM SR CAPSULES Diltiazem (HCl) 90mg 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. This medicinal product Pregnancy (unless essential), lactation. contains substance(s) B Low cardiac reserve, cardiac failure, prohibited for use in specific hepatic impairment, elderly. Contains lactose. Driving or using machines. sports only (as listed in C Caution: CYP3A4 inhibitors/ inducers, WADA Prohibited List 2010). other antihypertensives incl. b-blockers. A Ankle swelling. Headache, fatigue, Athletes requesting to use dizziness, asthenia, palpitations, flushing, nausea, this product in these specific dyspepsia, abdominal pain. once daily. Tabs. must be swallowed whole with water. Q Not recommended.
Anti-Doping Information
s
sports are required to apply for a TUE.
AMLODE 2MO
Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine besilate). White oblong, bevelled tab. scored on one side and marked with strength on other. 5mg-28, A8.33; 10mg-28, A12.50. S Essential hypertension. P 5mg once daily with water. If no sufficient effect within 2-4 weeks, may be increased to 10mg daily (as single dose). Q Under 18 years, not recommended. D Hypersensitivity to dihydropyridine derivatives. 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 Hepatic impairment, cardiac failure, low cardiac reserve, elderly. C Caution: CYP3A4 inhibitors/inducers. Other antihypertensives (e.g. a/b blockers, ACEinhibitors, diuretics). A Ankle swelling, headache, facial flushing, dizziness, fatigue, asthenia, palpitations, abdominal pain, nausea, dyspepsia.
AMLOTAN
Clonmel
2MO 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. ++
AMOLIN
Ergha
3MO Cardio-selective b-blocker. Atenolol 25mg, 50mg, 100mg. White film-ctd tabs. marked C23, C24 and C25 resp. 25mg-30, A2.60; 50mg-30, A3.93; 100mg-30, A5.16. S Hypertension. P 50-100mg daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
APRESOLINE
Novartis
2MO
Vasodilator. Hydralazine (HCl) 20mg. 2ml amp. 5, A1.87. S Hypertensive emergencies, including pre-eclampsia and toxaemia of pregnancy, and in hypertension with renal complications. P Parenteral: Initially 5-10mg by slow IV inj; if necessary repeat inj. after 20-30min (monitor BP and heart rate throughout). Satisfactory response defined as fall in diastolic BP to 90/ 100mmHg. May also be given by continuous IV inf, beginning with 200-300mcg/min. Maintenance Rowex flow rates 50-150mcg/min. Q Not recommended.
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 D Severe tachycardia and HF with high cardiac output, myocardial insufficiency due to mechanical obstruction, idiopathic SLE and related disease, dissecting aortic aneurysm, cor pulmonale. First half of pregnancy. B Moderate to severe renal impairment or hepatic dysfunction (adjust dose). Coronary or cerebrovascular disease. Lactation. Cardiac failure. Reported: Peripheral neuritis; reduction in Hb, red cell counts (discontinue if occurs); SLE like syndrome with prolonged treatment (determine ANF and urine analyses approx. every 6 months). Driving/using machines. C Caution: TCAs, MAOIs, alcohol, major tranquilisers, CNS depressants, anaesthetics, diuretics, antihypertensives, diazoxide, certain bblockers (propranolol). A Tachycardia, hypotension, angina, headache, flushes, arthralgia, myalgia, GI disturbances.
HYPERTENSION 2.4 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. Q Not recommended. D Severe electrolyte imbalance, hypovolaemia, hypotension, hypokalaemia, precoma associated with hepatic cirrhosis, advanced renal failure, digitalis intoxication. Pregnancy, lactation. B Impaired micturition or prostatic hypertrophy. Severely impaired renal function (monitor serum electrolytes). C Aminoglycoside, cephalosporin, APROVEL sanofi-aventis/BMS corticosteroids, carbenoxolone, laxatives, antihypertensive agents, cardiac glycosides, non2MO depolarising muscle relaxants, drugs used in Angiotensin II antagonist. Irbesartan 75mg, treatment of gout, lithium, NSAIDs. 150mg, 300mg. White oval tabs. marked with heart symbol and 2771, 2772 or 2773. 75mg-28, ATACAND AstraZeneca A16.49; 150mg-28, A18.33; 300mg-28, A24.74. 2MO S Essential hypertension. Angiotensin II antagonist. Candesartan cilexetil P Initially 150mg once daily. Usual 2mg, 4mg, 8mg, 16mg. White, white, light pink maintenance dose 150mg once daily. Increase if and pink tabs. resp. 4mg, 8mg and 16mg scored. necessary to 300mg once daily or add other 2mg-14, A7.89; 4mg-28, A14.42; 8mg-28, A18.33; hypertensive agents. Haemodialysis: Consider 16mg-28, A24.74. 75mg starting dose. R Over 75 years, consider starting dose of S Hypertension. P Initially 8mg once daily. May be 75mg once daily. increased to 16mg once daily. Effect within 4 Q Not recommended. weeks. Max. 32mg once daily. Renal impairment/ D Pregnancy. vol. depletion: Initially 4mg daily. Mild/moderate B Renovascular hypertension, renal hepatic impairment: Initially 2mg daily. impairment, hyperkalaemia, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, Q Under 18 years, not recommended. D Severe hepatic impairment, cholestasis. primary aldosteronism. If inadvertently taken Pregnancy, lactation. during pregnancy, check skull and renal function B Correct volume/salt depletion before with echography. Lactation not recommended starting therapy. Severe or end-stage renal (esp. newborn or preterm infants). Contains impairment, renal artery stenosis, aortic or mitral lactose. stenosis, obstructive hypertrophic cardiomyopathy. C K+sparing diuretics, K+suppl., lithium. A Headache, musculo-skeletal trauma, Primary hyperaldosteronism (not recommended). flushing. Monitor serum K+ in patients with HF or renal 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)
impairment. Contain lactose. C Caution: K+sparing diuretics, K+suppl., heparin, lithium, antihypertensives, indomethacin. A Dizziness/vertigo, headache, respiratory infection.
ATACAND PLUS
AstraZeneca
5MO Angiotensin II antagonist/thiazide diuretic. Candesartan cilexetil 16mg, HCTZ 12.5mg. Peach scored tab. 28, A24.74. S Essential hypertension where monotherapy is not sufficient. P 1 once daily. Q Not recommended. D Severe hepatic or renal impairment, refractory hypokalaemia and hypercalcaemia. Gout. Pregnancy, lactation. B Renal artery stenosis, intravascular volume depletion, renal impairment/kidney transplantation, hepatic impairment, aortic or mitral valve stenosis, primary hyperaldosteronism, metabolic and endocrine effects. C K+sparing diuretics, K+suppl., lithium, NSAIDs, cholestyramine, anticholinergics, alcohol, barbiturates, anaesthetics. A Headache, back pain, dizziness, respiratory infection, influenza like symptoms, sinusitis, bronchitis, UTI, nausea, tachycardia, fatigue, abdominal pain, pharyngitis.
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 Hypertension. P 50mg once daily increasing to 100mg if required. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
ATECOR CT
Rowex
5MO Cardioselective b-blocker/ thiazide diuretic. Atenolol 50mg, chlorthalidone 12.5mg; atenolol 100mg, chlorthalidone 25mg. Both white film-ctd tabs. scored one side. 50/12.5-30, A4.85; 100/ 25mg-30, A6.97. S Hypertension. P 1 daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
ATENETIC
Gerard
5MO 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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
43
2.4 HYPERTENSION
CIRCULATORY SYSTEM
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 ATENI Gerard artery stenosis in a single kidney (strict supervision with low doses; careful dose adjustment), pre3MO existing renal impairment (monitor blood K+ and Cardioselective b-blocker. Atenolol 50mg, 100mg creatinine concentrations), major surgery, white tabs. Both marked AT and strength one anaesthesia, diabetes. May occur: Systemic side, G on reverse. 50mg-28, A4.16; 100mg-28, hypotension, angioedema (withdraw immediately), A5.38. anaphylactoid reactions in haemodialysis patients S Hypertension. P 50mg once daily increasing to 100mg if or during desensitisation treatment, acute renal insufficiency in patients with HF (usually required. reversible), hepatic insufficiency, neutropenia/ Q Not recommended. agranulocytosis, cough. D See 2.4, b-blockers Drug Presc. Notes. C Not recommended: Lithium. Caution: ATENOGEN Antigen Diuretics, K+ sparing diuretics, K+ supplements, salt substitutes containing K+, NSAIDs (incl. 3MO acetylsalicylic acid r 3g/day), other Cardioselective b-blocker. Atenolol 25mg, 50mg, antihypertensives, certain anaesthetics, tricyclic 100mg. White, white, orange film-ctd tabs. antidepressants and antipsychotic agents, marked AT/25, AT/50, AT/100, resp. All marked sympathicomimetics, anti-diabetics. with makerâ&#x20AC;&#x2122;s symbol. 25mg-28, A2.49; 50mg-28, A Dizziness, headache, orthostatic effects A3.77; 100mg-28, A5.38. (incl. hypotension), diarrhoea, vomiting, renal S Cardiac arrhythmias. Long-term dysfunction, impotence. prophylaxis after recovery from acute MI. Angina pectoris. Essential hypertension. BELLRAMIL Ranbaxy P Arrythmias: 50-100mg daily. Prophylaxis 2MO after recovery from MI: 100mg daily. Hypertension: ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 50mg daily increasing to 100mg daily if required. hard cap. with resp. yellow, orange, maroon or Allow time to achieve full effects (1-2 weeks) blue cap /white body, imprinted with R on cap before determining need to increase to 100mg and strength on body. Contain white to off-white daily. Angina: 100mg daily as a single dose or as granular powder. 2.5mg-30, A5.50; 5mg-30, 50mg twice daily. A7.10; 10mg-30, A9.60. Q Not recommended. S Mild to moderate hypertension. D See 2.4, b-blockers Drug Presc. Notes. P Initially 1.25mg once daily. Increase dose ATENOMEL Clonmel incrementally at intervals of 1-2 weeks up to max 10mg once daily. Maintenance: 2.5-5mg. If 3MO response unsatisfactory at 10mg, combination Cardioselective b-blocker. Atenolol 25mg, 50mg, treatment recommended. In diuretic treated 100mg. White tab. marked C23, C24, C25. 50 and patients, discontinue diuretic 2-3 days before 100mg scored. 25mg-30, A2.60; 50mg-30, A3.94; initiating. Patients with congestive HF, start 100mg-30, A5.01. treatment at 1.25mg under close medical S Hypertension. supervision in hospital. P 50-100mg daily. R Caution Q Not recommended. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. D History of angioneurotic oedema, haemodynamically relevant renal artery stenosis BELLISIN Ranbaxy (bilateral or unilateral in single kidney). Aortic or 2MO mitral valve stenosis or outflow obstruction. ACE inhibitor. Lisinopril (as dihydrate) 10mg, Hypotensive or haemodynamically unstable 20mg. Uncoated tabs debossed with strength on 1 patients. Pregnancy, lactation. side. Light yellow biconvex cap-shaped tab. B Renal impairment risk; assess renal (10mg); light peach biconvex cap-shaped tab. function prior to and during treatment. Caution: A A (20mg). 10mg-28, 7.87; 20mg-28, 9.32. Impaired liver function, volume- and saltdepletion, anaesthesia. May occur rarely: S Hypertension. Renal disease in Agranulocytosis and bone marrow depression, hypertensive patients with Type 2 diabetes and reduction in red cell count, Hb content and incipient nephropathy. platelet count, hyperkalaemia. Avoid P Hypertension: Initially, 10mg. Highly asthma, obstructive airways disease. Poor cardiac reserve. Renal impairment, thyrotoxicosis/ hypoglycaemia, anaesthesia, hypokalaemia, pulse rate, serum uric acid, Prinzmetalâ&#x20AC;&#x2122;s angina, allergens, psoriasis. Driving/using machines. C Halogenated anaesthetics, class 1 antiarrhythmics, NA or adrenaline. Adrenergic blockers, Ca++ channel blockers, hypoglycaemics, cardiac glycosides, non-depolarising muscle relaxants. Clonidine, lithium, dihydropyridines, sympathomimetics, CYP450 inhibitors, alcohol, hydralazine. Prostaglandin synthetase inhibitors. A Blood dyscrasias, electrolyte disturbances, hyperuricaemia, impaired glucose tolerance, hyponatraemia, confusion, mood changes, sleep disturbance, dizziness, headache, paraesthesia, ocular changes, bronchospasm, GI disturbances, alopecia, rash, muscular fatigue, impotence, fatigue.
44
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+.
BENETOR
Daiichi Sankyo
2MO Angiotensin II antagonist. Olmesartan medoxomil 10mg, 20mg, 40mg. White, film-ctd tabs. with C13, C14 and C15 resp. embossed on one side. 10mg, 20mg: circular; 40mg: oval. 10mg-28, A14.74; 20mg-28, A17.70; 40mg-28, A22.29. S Essential hypertension. P Initially, 10mg once daily. Optimal dose, 20mg once daily. Max.: 40mg, daily. Mild to moderate renal impairment: Max., 20mg once daily. R Max., 20mg once daily. Q 18 years and under, not recommended. D Pregnancy, lactation. Biliary obstruction. B Hepatic impairment and severe renal impairment: Not recommended (limited experience). Intravascular volume depletion, renovascular hypertension, kidney transplantation, hyperkalaemia, lithium, aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy, primary aldosteronism, ethnic differences, other conditions stimulating renin-angiotensinaldosterone system, ischaemic heart disease or ischaemic cerebrovascular disease. C K+ suppl., K+ sparing diuretics and lithium (not recommended). NSAIDs and angiotensin II antagonists (monitor renal function at beginning of treatment and ensure regular hydration). Well tolerated additive reduction in BP with HCTZ. A Dizziness, bronchitis, cough, pharyngitis, rhinitis gastro-intestinal disorders, arthritis, back pain, skeletal pain, haematuria, UTIs, chest pain, fatigue, flu-like symptoms, peripheral oedema, pain.
BENETOR PLUS
Daiichi Sankyo
5MO Angiotensin II antagonist/thiazide diuretic. Olmesartan medoxomil/HCTZ, 20mg/12.5mg, 20mg/ 25mg. Round film-ctd tab. 20mg/12.5mg, reddishyellow; 20mg/25mg, pinkish embossed with C22, C24 resp. 28, A17.82. S Essential hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil alone. P Initially, 20mg/12.5mg once daily. If BP not adequately controlled 20mg/25mg 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 (max. daily dose). Q 18 years and under, not recommended. D Severe renal/hepatic impairment. Cholestasis and biliary obstructive disorders. Refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia. Pregnancy, lactation. B Intravascular volume depletion (risk of symptomatic hypotension). Impaired renal function (monitor serum K+, uric acid and creatinine levels). Caution: Renovascular hypertension, hyperkalaemia, diabetes, aortic or mitral value stenosis, obstructive hypertrophic cardiomyopathy, ischaemic heart or cerebrovascular disease. Not recommended: Recent kidney transplant, hepatic impairment, primary aldosteronism. Monitor serum electrolytes regularly. C Not recommended: K+ suppl., K+ sparing diuretics, lithium. Caution: Amifostine, alcohol, barbiturates, narcotics, antidepressants, NSAIDs, other antihypertensives, baclofen, Ca++ salts, cholestyramine/colestipol resins, digitalis glycosides, class Ia and III antiarrhythmics, some antipsychotics, non-depolarizing skeletal muscle relaxants, anticholinergics, antidiabetics, bblockers, diazoxide, pressor amines, probenecid, sulfinpyrazone, allopurinol, amantadine, cytotoxic agents, salicylates, methyldopa, cyclosporine, tetracyclines. A Dizziness, fatigue, bronchitis, cough, pharyngitis, rhinitis, GI disorders, arthritis, haematuria, UTI, pain, fatigue, flu-like symptoms, peripheral oedema.
BETA-ADALAT 3MO
HYPERTENSION 2.4 gynaecomastia, impotence. Mood changes, MI, ischaemic pain (discontinue).
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 Hypertension, adjuct in thyrotoxicosis, prophylaxis of upper GI bleeding in patients with portal hypertension and oesophageal varices. P Hypertension: Initially 160mg daily taken morning or evening; may be increased if necessary in 80mg increments. All other indications: 80mg every morning or evening; may be increased if necessary to 160mg daily up to 240mg daily. Portal hypertension: Target 25% reduction in resting heart rate; max. dose 320mg once 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; 100mg white tab. scored and marked A/ME. 50mg-100, A3.51; 100mg-100, A6.52. S Hypertension. Adjunct in thyrotoxicosis. P Hypertension, initially 100mg daily, increasing if required to 400mg daily in one or two divided doses. Thyrotoxicosis, 50mg four times daily. Bayer Schering Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
Cardioselective b-blocker/class II Ca++ antagonist. Atenolol 50mg, slow-release nifedipine 20mg. Reddish-brown cap. marked with name and Bayer cross. 28 (Cal/Pk), A11.87. S Hypertension, where b-blocker or calcium antagonist monotherapy is inadequate. P 1 daily, increasing to 1 every 12 hours if necessary. R Max. 1 daily. Q Not recommended. D Women of child bearing potential. HF. 2nd or 3rd degree heart block. Cardiogenic shock, use in conjunction with other cardio-depressant drugs, severe bradycardia, acute angina attacks, unstable angina pectoris, severe aortic stenosis, during or within one month of MI, wheezing, asthma, severe renal failure. Pregnancy, lactation. B Cardiac conduction defects or poor cardiac reserve. OAD. Renal or hepatic impairment. Diabetes. Anaesthesia. Elderly. C Antihypertensives, cimetidine, quinidine, rifampicin, digoxin, cardiodepressants, adrenergic neurone blocking drugs, non-cardio selective b blockers, grapefruit juice. A Flushing, headache, fatigue, dizziness, dry eyes, skin rash, oedema, hypersensitivity type jaundice (rare), gingival hyperplasia,
PRICES The prices listed in MIMS Ireland are trade prices and do not include pharmacist dispensing fees. They are included as a guide to relative cost and should not be regarded as having any direct relationship with retail prices.
BIOCARD
Niche
3MO a/b blocker. Carvedilol 3.125mg, 6.25mg, 12.5mg, 25mg. Round bevel edged tabs. (3.125mg), scored on one side (25mg). Oval tab., marked S2 on one side (6.25mg scored) or S3 on one side (12.5mg scored). All slightly biconvex, white. 3.125mg-28, A5.09; 6.25mg-28, A6.23; 12.5mg-28, A7.45; 25mg-28, A8.32. S Hypertension P Initially, 12.5mg once daily for 2 days. Thereafter, 25mg once daily. Max. 50mg once daily or in divided doses. Dose titration at 2-week intervals. Q Under 18 years, not recommended. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction.
BISOCOR
tablet with a cross score encoded BIS and strength on one side. 5mg-28, A5.34;10mg-28, A6.01. S Hypertension. P Should be taken with liquid (not chewed), in the morning. Initially 5mg; usual dose 10mg once daily; max 20mg/day. 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 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.
BISOPINE
Pinewood
3MO Cardioselective b-blocker. Bisoprolol hemifumarate
Niche 5mg, 10mg. Resp. pale yellow or beige mottled
tabs. marked BI above breakline 5 or 10 below. 5mg-28, A5.90; 10mg-28, A6.65. S Hypertension. P 5-20mg once daily, usually 10mg once daily. Upon discontinuation, diminish slowly by weekly halving dose. Severe renal impairment: Max dose 10mg daily. R Lowest dose recommended. Regular monitoring during initiation of treatment. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Acute HF or during episodes of HF decompensation requiring IV inotropic therapy. Combinations with floctafenine and sultopride. BISOP Rowex B See 2.4, b-blockers Drug Presc. Notes. 3MO Iodated contrast products. Driving/operating machinery. Contains lactose. Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Resp. yellow or apricot, round film-ctd C See 2.4, b-blockers Drug Presc. Notes.
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, A5.28. 10mg-28, A5.99. S Hypertension. P 5-20mg once daily. Usually 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
45
2.4 HYPERTENSION
CIRCULATORY SYSTEM
impairment: 2mg initially. Q Safety and efficacy not established. D Pregnancy, lactation. Severe hepatic impairment and/or cholestasis. BLOPRESS Takeda B Not recommended: Primary hyperaldosteronism. Caution: Haemodynamically 2MO relevant aortic mitral valve stenosis, obstructive Angiotensin II antagonist. Candesartan cilexetil hypertrophic cardiomyopathy, severe CHF, 2mg, 4mg, 8mg, 16mg, 32mg. 2mg: Round white tab. 4mg: Round white tab. with single score line underlying renal disease (incl. renal artery stenosis), haemodialysis (carefully titrate with on both sides. 8mg: Round pale pink tab. with single score line on both sides. 16mg: Round light thorough monitoring of BP), anaesthesia+and pink tab. with one convex side embossed with 16 surgery. Monitor renal function, serum K and creatinine levels (HF, elderly, renal impairment, and one scored flat side. 32mg: Round light pink concomitant ACE inhibitor). Hypotension may tab. with convex sides, debossed 32 on one side occur. Contains lactose. and scored on the other. 2mg-7, A1.81; 2mg-28, C Possible interaction with NSAIDs. A7.26; 4mg-7, A3.30. 4mg-28, A13.20; 8mg-28, Antihypertensive effect may be enhanced by other 15.81; 16mg-28, A19.22; 32mg-28, A24.63. antihypertensives. K+ -sparing diuretics, K+ S Essential Hypertension. supplements, salt substitutes containing K+, or P Initially 8mg once daily. Usual other medicinal products that may increase K+ maintenance dose: 8mg, may be increased to levels, lithium. 16mg. If blood pressur not sufficiently controlled A Respiratory infection, dizziness/vertigo, after 4 weeks, may be increased to 32mg. Renal impairment (incl. haemodialysis) and intravascular headache. volume depletion: 4mg initially. Moderate hepatic Anti-cholinesterastic drugs. Amifostine. NSAID. A See 2.4, b-blockers Drug Presc. Notes. Headache.
BLOPRESS PLUS
Takeda
5MO Angiotensin II antagonist/thiazide diuretic. Candesartan cilexetil/HCTZ 8mg/12.5mg, 16mg/ 12.5mg, 32mg/12.5mg, 32mg/25mg. Resp. white, light pink, light yellow or light pink scored oval tabs marked with strength and C (8mg/12.5mg, 16mg/12.5mg), C1 (32mg/12.5mg) or C2 (32mg/ 25mg). 8mg/12.5mg-28, A15.81; 16mg/12.5mg-28, A19.22; 32mg/12.5mg-28, A24.63; 32mg/25mg-28, A24.63. S Essential Hypertension, where monotherapy with candesartan cilexetil or HCTZ is not sufficient. P 1 tab. once daily. Titrate candesartan dose before switching to Blopress Plus (esp. in renal impairment and volume depleted patients). When clinically appropriate direct switch from 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, A4.14; 2.5mg-28, A5.89; 5mg-28, A8.23; 10mg-28, A11.22. S Hypertension.
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
CIRCULATORY SYSTEM 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. 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.
HYPERTENSION 2.4 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, A7.99; 25mg-56, A9.10; 84, A24.72; 50mg-56, A15.52; 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 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, probenecid, immunosuppressants. BYZESTRA Ergha A Rash, loss of taste, cough. Rarely neutropenia, agranulocytosis, proteinuria. 2MO Lisinopril dihydrate 2.5mg, 5mg, 10mg, 20mg. CAPOZIDE BMS White tabs marked LSN followed by strength. 2.5mg-28, A5.35; 5mg-28, A7.55; 10mg-28, A9.31; 5 M O A 20mg-28, 10.70. ACE inhibitor/thiazide diuretic. Captopril 50mg, S Arterial hypertension alone or HCTZ 25mg. White scored tab. marked SQUIBB concomitantly with other antihypertensive agents. 390. 28, A12.16. Renal disease in hypertensive patients with type 2 5 M O diabetes mellitus and incipient nephropathy. ALSO HALF CAPOZIDE Captopril 25mg, HCTZ P Arterial hypertension: Initially, 5-10mg 12.5mg. White scored tab. marked SQUIBB 536. in the morning; titrate at minimum 3 week 28, A8.59. intervals; maintenance, 20mg once daily; max. S Mild to moderate hypertension in 80mg once daily. Renal complications of diabetes patients who have been stabilised on captopril mellitus: 10mg once daily; may be increased to and a thiazide diuretic. 20mg once daily to achieve BPQ90mmHg. P 1 daily. Moderate renal impairment: As per elderly. Q Not recommended. R Initially, 2.5mg in the morning; D Aortic stenosis. Pregnancy, lactation. See maintenance usually 5-10mg daily; max. 20mg SPC. daily. B With renal impairment, collagen Q Not recommended. vascular disease, immunosuppressant therapy, or D Angioneurotic oedema, severe renal leukopenic drugs monitor white cell count and impairment, aortic or mitral valve stenosis, urinary protein. Anaesthesia. Diabetes. Hepatic hypertrophic cardiomyopathy, haemodynamically impairment. Gout. unstable patients after acute MI, SBPR100mmHg. C Lithium, sulphonamide-derived drugs, Lactation, pregnancy. Permanent haemodialysis, NSAIDs, allopurinol, procainamide, probenecid, cardiogenic shock. immunosuppressants, vasodilators, clonidine, B Initiate therapy/adjust dose in hospital K+sparing diuretics, K+suppl., antihypertensives. in: High risk for severe acute hypotension, e.g. vol/ A Rash, loss of taste, cough. Rarely salt depletion, pre-existing hypotension, neutropenia, agranulocytosis, proteinuria. renovascular hypertension, renal artery stenosis, unstable cardiac failure, renal impairment, highCAPTOR Rowex dose vasodilator therapy, patients r70 years, 2MO cerebrovascular disease, malignant hypertension. Discontinue or reduce diuretic therapy for 2-3 days ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. White tabs. scored one side (6.25mg, 12.5mg); before treatment and start with 2.5mg daily. white tabs. cloverleaf form with facet and quarter Primary hyperaldesteronism (not recommended). scored both sides (25mg, 50mg). 12.5mg-60, Hypertrophic cardiomyopathy, surgery; caution. C Caution: K+-sparing and other diuretics, A8.54; 100, A14.25; 25mg-60, A9.73; 100-A16.22; + K suppls, NaCl, antihypertensives, analgesics, anti- 50mg-60, A16.60; 100, A27.67. inflammatory agents, lithium, alcohol, S Hypertension. anaesthetics/ narcotics/ hypnotics, P Initially, 25-50mg daily in two divided sympathomimetics, oral antidiabetics, antacids, doses; may be increased with intervals of at least 2 NSAIDs. weeks, to 100-150mg/day in two divided doses. A Hypotension, headache, tiredness, dry With diuretics, once-daily dosing regimen may be cough, sore throat, bronchitis, nausea, rash, appropriate. Renal impairment, initiate at a lower angioneurotic oedema, hyperkalaemia. dose (see SPC). R Initially 6.25mg twice daily. CAPOTEN BMS 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.
CAPTOR-HCT
Rowex
5MO ACE inhibitor/thiazide diuretic. Captopril 50mg, HCTZ 25mg. Off-white scored tab. 30, A13.00.
5MO ALSO CAPTOR-HCT 25/12.5 Captopril 25mg, HCTZ 12.5mg. Off-white scored tab. 30, A9.18. S Hypertension not adequately controlled by captopril alone or HCT alone. P Maintenance, 50/25mg once daily in the morning. Renal impairment, salt/vol. depletion, diabetes: 25/12.5mg once daily. R 25/12.5mg once daily. Q Not recommended. D Angioneurotic oedema. Severe renal or hepatic impairment. 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. Electrolyte imbalance, gout, neutropenia/ agranulocytosis, proteinuria. Contains lactose. C K+sparing diuretics, K+suppl., diuretics, vasodilators, lithium, TCAs, allopurinol, procainamide, cytostatic or immunossupressive drugs, NSAIDs, sympathomimetics, antidiabetics. Amphotericin B (parenteral), carbenoxolone, corticosteroids, ACTH or stimulant laxatives, Ca++ salts, cardiac glycosides, cholestyramine resin and colestipol, nondepolarising muscle relaxants, drugs associated with torsades de pointes. A Pruritus, rash, alopecia, dry cough, loss of taste, dizziness, sleep disorders, GI disorders.
CARDURA XL
Pfizer
2MO Selective a-blocker. Doxazosin 4mg, 8mg. White prolonged-release round biconvex tabs. with hole in one side, marked CXL4 or CXL8. 4mg-28 (Cal/ Pk), A18.87; 8mg-28 (Cal/Pk), A37.54. S All grades of hypertension as monotherapy or with thiazide diuretic, b-blocking drugs, Ca++ antagonists or ACE inhibitors. P Initially 4mg once daily. If necessary, may be increased to 8mg once daily (max. dose). Q Under 12 years, not recommended.
2MO 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), A8.21; 2mg-28, A10.95. 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
47
2.4 HYPERTENSION
CIRCULATORY SYSTEM 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.
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. CENTYL LEO Pharma A Headache, upper respiratory tract symptoms, dizziness, fatigue, musculoskelatal pain, 5MO CARSEM XL Teva Thiazide. Bendroflumethiazide 2.5mg, 5mg. White, cough, rhinitis, nausea, diarrhoea, rash. 2MO circular, flat, slightly bevelled tabs. 2.5mg-500, CO-BETALOC Pharmacia A21.25; 5mg-100, A6.38; 500, A31.88. Selective a-blocker. Doxazosin (as mesilate), 4mg. 5MO White, round biconvex film-ctd prolonged-release S Hypertension, alone or in combination tab. with DL bossing on one side. 28, A12.82. with other antihypertensives. Cardioselective b-blocker/thiazide diuretic. P 2.5-5mg once daily. S Essential hypertension: Not for 1st-line Metoprolol tartrate 100mg, HCTZ 12.5mg. White D Severe electrolyte imbalance. Severe treatment, may be used as monotherapy in scored tab. marked A/MH. 28, A8.96. renal/hepatic impairment. Addison’s disease, patients who fail to respond/have S Mild to moderate hypertension. established gout, ulcer or GI tract obstruction. contraindications to other agents; as 2nd or 3rd P 1-2 daily in single or divided doses. B K+suppl. may be required (monitor line treatment in combination with other Q Not recommended. antihypertensives. D See SPC. electrolytes). Renal/hepatic impairment, P 4mg once daily. May be increased to obstruction of urinary tract, disorders altering CO-DIOVAN Novartis 8mg once daily. electrolyte balance. May: Cause hyperuricaemia Q Not recommended. and aggravate gout; activate SLE. Diabetes. 5MO D Benign hyperplasia and concomitant Pregnancy, lactation. Contains lactose. Angiotensin II antagonist/thiazide. Valsartan 80mg, congestion of upper urinary tract, chronic UTIs, C Contra: Lithium. Cardiac glycosides, HCTZ 12.5mg. Light orange ovaloid film-ctd tab. bladder stones. Overflow bladder, anuria, hypotensive agents (adjust dose). TCAs, marked HGH on one side and CG on reverse. 28, progressive renal impairment. History of hypoglycaemic agents, NSAIDs, probenecid, A17.80. oesophageal or GI obstruction, decreased GI tract cholestyramine, other drugs known to cause S Hypertension where monotherapy lumen diameter. Lactation. Pregnancy (unless photosensitivity. proves inadequate. A Headache, dizziness, fatigue, postural clearly needed). P 1 daily. Mild to moderate hepatic hypotension, GI disorders. Electrolyte disturbances impairment without cholestasis: Max. valsartan B Severe hepatic impairment, not recommended. Monitor for postural effects when (long term use). 80mg daily. initiating therapy. Caution: Acute heart disease, Q Under 18 years, not recommended. CENTYL K LEO Pharma mild-moderate hepatic impairment, Diabetic 5MO Autonomic Neuropathy, cataract surgery. Not for 5MO ALSO CO-DIOVAN 160MG/12.5MG Valsartan use as single agent in patients with 1 or more Thiazide/K+suppl. Bendroflumethiazide 2.5mg, K+ 160mg, HCTZ 12.5mg. Dark red, ovaloid film-ctd. additional cardiovascular disease risk factors. May Cl 573mg (7.7mmol K+) in slow -release wax core. tab. Imprinted HHH on one side and CG on the influence plasma renin activity and urinary Green, sugar-ctd, oval, modified release tab. 250, other. 28 (2x14): A23.87. excretion of vanillylmandelic acid. Driving/ A31.10. P 1 daily. operating machinery. S Hypertension alone or in combination Q Under 18 years, not recommended. C Not recommended: Tadalafil. Caution: with other antihypertensives. 5MO Sildenafil, vardenafil, other antihypertensives, non- P 1-2 every morning. ALSO CO-DIOVAN 160MG/25MG Valsartan 160mg, steroidal antirheumatics, estrogens, Q Not applicable. HCTZ 25mg. Brown, ovaloid tab. marked with HXH sympathomimetics, medicinal products which may D Precoma associated with hepatic on one side and NVR on reverse. 28, A24.33. influence hepatic metabolism (e.g. cimetidine). cirrhosis, Addison’s disease. Severe renal P 1 daily. Start with 160mg/12.5mg for A Apathia, muscle cramps, fatigue, impairment. Hyperkalaemia. min. 4-8 weeks. malaise, headache, somnolence, accomodation B Diabetes, renal impairment, obstruction Q Under 18 years, not recommended. disturbances, palpitations, chest pain, giddiness, of urinary tract; caution. Obstruction of small 5MO dizziness, oedema, orthostatic dysregulation, bowel, ulceration (discontinue if occurs). ALSO CO-DIOVAN 320MG/12.5MG Valsartan dyspnoea, rhinitis, GI disorders, frequent desire to Pregnancy, lactation (only if essential). 320mg, HCTZ 12.5mg. Pink, ovaloid, beveled edge, micturate, increased micturation, delayed C K+sparing diuretics, lithium. Caution: film-ctd tab., debossed with NVR on one side and ejaculation, asthenia. Cardiac glycosides, antihypertensives. HIL on the reverse. 28, A29.13. A Rash, photosensitivity, myopia P 1 daily with fluid. When clinically CATAPRES Boehringer Ing. aggravation, blood dyscrasias, gout, fatigue. Acute appropriate direct change from monotherapy to pancreatitis, hyperuricaemia, GI upset, oliguria, 2MO the fixed dose combination may be considered. dizziness, headache, muscle pain, thirst, dry Max. effect within 4-8 weeks Central a-agonist. Clonidine (HCl) 100mcg, mouth. Vasculitis. Q Under 18 years, not recommended. 300mcg. White round tabs marked O1C/O1C and 5MO O3C/O3C resp. on one side and maker’s symbol on Meda reverse. 100mcg-100, A7.89; 300mcg-100, A18.37. CIBACEN ALSO CO-DIOVAN 320MG/25MG Valsartan 320mg, 2NO 2MO HCTZ 12.5mg. Yellow, ovaloid, beveled edge, filmctd tablet, debossed with NVR on one side and CTI ALSO CATAPRES INJECTION Clonidine 150mcg/ml. ACE inhibitor. Benazepril (HCl) 5mg cap-shaped on the reverse. 28, A32.24. Sln for inj. in 1ml amp. 5, A1.69. pale yellow film-ctd tab scored both sides and S Hypertension that has failed to respond marked CG one side and LV on reverse. 10mg dark P 1 daily, with fluid. Start with lower yellow film-ctd tab marked CG one side and HO adequately to other anti-hypertensives. strength (320mg/12.5mg) and continue for at least on reverse. 5mg-28, A9.33; 10mg-28, A12.44. P 50-100mcg three times daily increasing 4-8 weeks before starting treatment with 320mg/ gradually. Optimal dose 300-1200mcg/day in S Hypertension. 25mg strength. Max. effect within 4-8 weeks. If no divided doses. P Initially 10mg once daily. Patients with relevant additional effect, consider dose reduction 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.
48
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
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, COVERSYL ARGININE Servier diabetes, surgery (discontinue 1 day before), aortic stenosis, long Q-T interval. Risk of arterial 2MO hypotension and/or renal insufficiency. Contains ACE inhibitor. Perindopril arginine 5mg, 10mg. lactose. 5mg: Light green, rod-shaped scored film-ctd tab C Not recommended: Lithium, K+ salts, K+with a symbol. 10mg: Green, round, biconvex, film-ctd tab with heart on one side and symbol on sparing diuretics, antidiabetics, Caution: Baclofen, NSAIDs, TCAs, neuroleptics, corticosteroids, reverse. 5mg-30, A14.12; 10mg-30, A22.59. tetracosactide, other antihypertensives, allopurinol, S Essential hypertension as monotherapy cytostatic or immunosuppressive agents, systemic or in combination with thiazide diuretics. corticosteroids, procainamide, anaesthetics, P Initially, 5mg daily as single dose. After diuretics, injectable gold, torsades de pointes 4 weeks, increase to 10mg once daily if required. inducing drugs, amphotericin B (by IV), Discontinue diuretic 3 days beforehand. If not glucocorticoids and mineralocorticoids (systemic possible, commence with 2.5mg. Renal route), tetracosactide, stimulant laxatives, cardiac insufficiency, 2.5mg according to creatinine glycosides, iodinated contrast media, Ca++, clearance. ciclosporin. R Initially, 2.5mg once daily; increase to A Paraesthesia, headache, dizziness, 5mg after 4 weeks, then 10mg if necessary. vertigo, vision disturbance, tinnitus, hypotension, Q Not recommended. D ACE inhibitor hypersensitivity. History of dry cough, dyspnoea, GI disorders, rash, pruritus, maculopapular eruptions, muscle cramps, asthenia. angioneurotic oedema (previous ACE treatment), hereditary or idiopathic angioedema. Pregnancy, COZAAR MSD lactation. B Symptomatic hypotension may occur in 2 M O COAPROVEL sanofi-aventis/BMS Angiotensin II antagonist. Losartan (K+) 12.5mg, patients with salt or volume depletion. Caution: 5MO Mitral valve stenosis, obstruction in the outflow of 50mg, 100mg. White film-ctd scored tab. marked 952, white film-ctd teardrop-shaped tab. marked Angiotensin II antagonist/thiazide. Irbesartan/HCTZ the left ventricle. Renal impairment. Dialysis with 960. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mg150mg/12.5mg; 300mg/12.5mg; 300mg/25mg. highflux membranes. Kidney transplantation, no 28, A30.80. Peach, peach, pink tabs marked 2875, 2876, 2788 data. Angioedema reported rarely (discontinue if resp. All: Biconvex, oval, film-ctd marked with a occurs). Patients at risk of hyperkalaemia. Contains 2 M O heart on reverse. 150/12.5mg-28, A18.33; 300/ ALSO COZAAR ORAL SUSPENSION Losartan K+, lactose. Surgery, anaesthesia. 12.5mg-28, A24.74; 300/25mg-28, A24.71. 2.5mg/ml (reconstituted susp.). White to off-white C Diuretics, K+ sparing diuretics, K++ S Essential hypertension in those powder and cloudy, colorless solvent for oral susp. containing salt substitutes, K supplements, inadequately controlled by either agent alone. 500mg/200ml, A50. lithium, NSAIDs, other antihypertensives and P 1 x 150/12.5mg tab. once daily where S Essential hypertension in adults, children vasodilators, antidiabetics, TCAs, antipsychotics, irbesartan 150mg or HCTZ taken alone do not and adolescents 6-18 years. Reduction in risk of anesthetics, sympathomimetics. control BP. Alternatively, 1 x 300mg/12.5 tab. once A Headache, dizziness, vertigo, stroke in hypertensive adults with LV hypertrophy. daily where irbesartan 300mg taken alone or Renal disease in adults with hypertension and type paresthaesia, vision disturbance, tinnitus, CoAprovel 150mg/12.5mg do not control BP. 1 x 2 diabetes mellitus with proteinuria r 0.5g/day as hypotension, cough, dyspnoea, GI disorders, rash, 300mg/25mg once daily may be admin. in patients pruritus, muscle cramps, asthenia. part of antihypertensive treatment. insufficiently controlled by CoAprovel 300mg/ P 50mg once daily. If necessary, increase 12.5mg. Max: 300mg/25mg once daily. COVERSYL ARGININE PLUS Servier to max. 100mg once daily (morning). May be Q Under 18 years, not recommended. admin. with other antihypertensives (e.g. 5MO D Severe renal impairment. Refractory hydrochlorothiazide) ACE inhibitor/antihypertensive diuretic. Perindopril Q Under 6 years, not recommended. Over hypokalaemia, hypercalcaemia. Severe hepatic arginine/indapamide, 5mg/1.25mg; 10mg/2.5mg impairment, biliary cirrhosis, cholestasis. 6 years: 20-50kg: 25mg once daily; may be White rod-shaped or round (resp.) tab. 5/1.25mgPregnancy. exceptionally increased to 50mg. q50kg: may be 30, A19.67; 10/2.5mg-30, A31.47. B Correct volume/salt depletion before exceptionally increased to 100mg. Not S Essential hypertension. 5mg/1.25mg: initiating therapy. Renal impairment: Monitor K+, recommended: Hepatic impairment, glomerular When BP inadequately controlled on perindopril creatinine and uric acid serum levels regularly. filtration rate Q 30ml/min/1.73 m2. Kidney transplantation, no data. Caution: Hepatic alone. 10mg/2.5mg: Substitution therapy, in D Severe hepatic impairment. Pregnancy. patients already controlled with perindopril and impairment; renal artery stenosis; aortic or mitral B History of angiooedema (closely indapamide given concurrently at the same dose stenosis, or obstructive hypertrophic monitor). Volume depletion may cause level. cardiomyopathy; diabetics; severe CHF, ischemic symptomatic hypotension. Monitor K+ and cc. P 1 daily preferably in the morning before Hepatic impairment, renal impairment, renal cardiopathy or ischemic CVD. Primary aldosteronism, not recommended. Hyperuricaemia/ a meal. artery stenosis, primary aldosteronism (not Q Not recommended. gout; hypercalcaemia; hypomagnaesemia; recommended), aortic or mitral stenosis, or D History of angioedema (Quincke’s hypersensitivity reactions, may occur. Monitor obstructive hypertrophic cardiomyopathy. serum electrolytes regularly. May exacerbate or oedema) with previous ACE inhibitor therapy. Galactose intolerance, Lapp lactase deficiency, activate SLE. If inadvertently taken during Hereditary/idiopathic angioedema. Hepatic glucose-galactose malabsorbtion. No sufficient pregnancy, skull and renal function should be encephalopathy. Severe and moderate hepatic therapeutic experience: HF with concomitant checked with echography. Lactation not impairment. Hypokalaemia. Severe and moderate severe renal impairment, severe HF, HF and recommended (esp. newborn or preterm infants). renal impairment . Dialysis patients. Untreated symptomatic life threatening cardiac arrhythmias. Contains lactose. decompensated heart failure. Pregnancy, lactation. Lactation (not recommended). Tabs contain C Lithium, not recommended. Caution: B Not recommended: Renal artery lactose. C Rifampicin, fluconazole, NSAID, K+ Other antihypertensives, K+ sparing diuretics, K+ stenosis, single functioning kidney. Monitor WBC
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, raised serum levels of cholesterol, triglyceride, uric acid. C Drugs that increase/decrease serum K+ levels, digitalis glycosides, drugs inducing torsades de pointes, antiarrhythmics, other antihypertensives, lithium, vit. D or Ca++ salts, antidiabetics, b-blockers, diazoxide, drugs for the treatment of gout (allopurinol, probenecid, sulfinpyrazone), anticholinergics, pressor amines, amantadine, anionic exchange resins, cytotoxics, NSAIDs, curare derivatives, cyclosporin, tetracyclines, alcohol, anaesthetics, sedatives, methyldopa. A Diarrhoea, fatigue, nasopharyngitis.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
49
2.4 HYPERTENSION
CIRCULATORY SYSTEM P 180mg once daily increasing gradually, as necessary to 360mg once daily. R Initially 120mg once daily, increasing gradually. MSD Q Not recommended.
sparing diuretics, K+ suppl. or salts, lithium. A Dizziness, vertigo, hypotension, asthenia/fatigue, hyperkalaemia, hypoglycaemia.
COZAAR COMP 5MO
2MO
Angiotensin II antagonist/thiazide. Losartan (K+)/ HCTZ 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg. Resp. yellow, white and yellow oval film-ctd tabs. marked 717, 745 and 747 50/12.5mg-28, A18.32; 100mg/12.5mg-28, A26.36; 100/25mg-28, A31.77. S Hypertension; not usually appropriate for initial therapy. P Start with 50mg/12.5mg once daily. If no response use 100mg/12.5mg or 100mg/25mg once daily (max. dose). Q Not recommended. D Therapy resistant hypokalaemia or hypercalcaemia. Severe hepatic impairment; cholestasis, biliary obstructive disorders. Refractory hyponatraemia. Symtomatic hyperuricaemia/gout. Severe renal impairment. Anuria. Pregnancy. Lactation. B Not recommended: Hepatic impairment, severe renal impairment.Caution: Renal disease and renal transplant recipients. Haemodynamically significant obstructive valvular disease, cardiomyopathy. May occur: SLE, gout, angioedema, symptomatic hypotension, increased triglycerides, cholesterol and serum calcium, impaired glucose tolerance. Monitor serum electrolytes. Contains lactose. C K+ sparing diuretics, K+ suppl. or salts, barbiturates, narcotics, alcohol, antidiabetics, other antihypertensives, colestyramine and colestipol resins, corticosteroids, pressor amines, muscle relaxants, lithium, NSAIDs (indometacin), rifampicin, fluconazole. A Insomnia, headache, dizziness, cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder, GI disorders, muscle cramp, back pain, leg pain, myalgia, asthenia, fatigue, chest pain, hyperkalaemia, mild reduction of haematocrit and haemoglobin.
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 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.
Monitor on initiation (risk of postural effects). Caution: Acute heart disease; minor/moderate hepatic impairment. Severe hepatic impairment, not recommended. Driving or operating machinery. C Caution: Sildenafil or other PDE-5 inhibitors. NSAIDs, oestrogens, symathomimetics, vanillylmandelic acid. A Dizziness, rhinitis, GI disorders, headache, fatigue, malaise, oedema, somnolence, asthenia, dry mouth.
DOXANE XL
Rowex
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 diameter of the GI tract or patients at increased 2MO 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 DILTAM RETARD Rowex undergoing dialysis. Primary aldosteronism. dizziness, oedema, orthostatic dysregulation, dyspnoea, rhinitis, constipation, dyspepsia, 2MO B Correct volume/salt depletion before increased micturation (or desire to), delayed Class III Ca++ antagonist. Diltiazem (HCl) 90mg. starting therapy. HF, recent MI; reduction in BP. ejaculation, asthenia. White sust.-release tab. 60, A12.38. Renal artery stenosis, kidney transplantation, S Mild to moderate hypertension. hepatic impairment, obstructive hypertrophic DOXATAN Clonmel P Initially 1 daily increasing to 2 daily if cardiomyopathy, aortic and mitral valve stenosis. required. C Caution: K+suppl., K+ sparing diuretics, 2MO antihypertensives, lithium. Q Not recommended. Selective a-blocker. Doxazosin mesilate (equiv. D Pregnancy, lactation. Sick sinus doxazosin) 1mg white tab. marked D1; 2mg, 4mg DOXACAR XL Gerard syndrome, 2nd or 3rd degree AV block, marked white oblong scored tabs. marked D2 or D4. 1mgbradycardia, decompensated cardiac failure. 28, A7.92; 2mg-28, A10.54; 4mg-28, A13.06. 2MO B Mild bradycardia, prolonged PR interval. Selective a-blocker. Doxazosin (as mesilate) 4mg. S Essential hypertension. Measure heart rate regularly in elderly and in P Initial dose 1mg once daily. If necessary, Prolonged release tab. White, round, biconvex patients with hepatic or renal impairment. the dosage may be increased to 8mg once daily tab. embossed DL. 28, A14.03. Diabetes. according to response. Max. 16mg daily. S Essential hypertension. C b-blockers, digoxin, cimetidine, Q Not recommended. P Initially 4mg once daily swallowed diazepam, antihypertensives, anaesthetics. 2 MO whole with water; may be increased to max. 8mg A Anorexia, nausea, bradycardia, oedema, once daily. Taken as monotherapy or in ALSO DOXATAN XL PROLONGED RELEASE rash, flushing, fatigue, AV block, headache, GI Doxazosin (as mesilate) 4mg. Prolonged release combination with thiazide diuretics, bdisturbance. adrenoceptor blocking agents, Ca++ antagonists or tab. White, round, biconvex tabs. marked with DL. 28, A13.79. an ACE-inhibitor. DILZEM XL Cephalon Q Not recommended. S Hypertension. As monotherapy or in 2MO D History of GI or oesophageal combination with thiazide diuretics, b++ Class III Ca antagonist. Diltiazem (HCl) 120mg, obstruction (or risk of). BPH with urinary outflow adrenoceptor blocking agents, Ca++ antagonists or 180mg, 240mg. Prolonged release hard capsules obstruction, chronic UTIs or bladder stones. ACE inhibitors. marked with cap. strength and logo. 120mg-28, Pregnancy (only if benefit outweighs risk), P Initially 4mg once daily swallowed A8.39; 180mg-28, A12.44; 240mg-28, A16.06. lactation. whole with water; may be increased to max. 8mg B Abnormally short transport time once daily. S Angina pectoris, incl. Prinzmetalâ&#x20AC;&#x2122;s through GI tract may cause incomplete absorption. Q Under 12 years, not recommended. angina. Mild to moderate hypertension.
50
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
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. A Palpitation, tachycardia, vertigo, GI disorders, asthenia, chest/ back pain, peripheral oedema, myalgia, dizziness, headache, cough, pruritus, urinary incontinence, postural hypotension.
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. 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 DOXEL Pinewood therapy, as vol. depletion may cause symptomatic hypotension. Contains lactose. 2MO C Other anti-hypertensive agents, Selective a-blocker. Doxazosin (as mesilate) 4mg. K+suppl., K+sparing and other diuretics, lithium, Prolonged release tab. White, round, biconvex TCAs, antipsychotics, anaesthetics, tab. marked DL. 28, A13.36. sympathomimetics, antidiabetics, antacids, NSAIDs, S Hypertension. As monotherapy or in combination with thiazide diuretic, b-blocker, Ca++ alcohol, immunosuppressants, allopurinol, procainamide. antagonist or ACE inhibitor. A Blurred vision, dizziness, hypotension, P Initially 4mg once daily swallowed headache, depression, cough, dyspnoea, asthenia, whole with water; may be increased to max. 8mg nausea, GI disorders, rash, angioneurotic oedema, once daily. serum creatinine increase, hyperkalaemia. Q Under 12 years, not recommended. D History of GI or oesophageal ENTRYDIL Orion obstruction, or any degree of decreased lumen 2MO diameter of the GI tract. Pregnancy (only if benefit outweighs risk), lactation. Class III Ca++ antagonist. Diltiazem 60mg. White B Acute heart diseases. Not recommended: film-ctd scored caplet coded DL60. 100, A17.16. Severe hepatic insufficiency. Caution: MildS Hypertension. moderate hepatic insufficiency. Postural P 30-120mg three times daily, usually hypotension may occur particularly at start of 60mg three times daily. therapy; driving / using machines. Pregnancy (only Q Not recommended. if benefit outweighs risk). Patients undergoing 2MO cataract surgery. ALSO ENTRYDIL CR Diltiazem 90mg, 120mg. C Caution: PDE-5 inhibitors. Modified release white scored film-ctd caplets A Delayed ejaculation, apathia, muscle marked DL 90 or DL 120. 90mg-100, A21.53; cramps, fatigue, malaise, headache, somnolence, 120mg-100, A35.60. accommodation disturbances, palpitations, chest P 120mg once or twice daily, increasing to pain, giddiness, dizziness, oedema, dyspnoea, 180mg twice daily if necessary. rhinitis, constipation, dyspepsia, increased Q Not recommended. micturation or desire to, asthenia. D Pregnancy. Sick sinus syndrome; 2nd or 3rd degree AV block; marked bradycardia, EMCOLOL Gerard decompensated cardiac failure. B Observe patients with mild bradycardia 3MO or a prolonged PR interval. Measure heart rate Cardioprotective b-blocker. Bisoprolol fumarate 5mg and 10mg. Yellow and orange heart-shaped, regularly in the elderly and in patients with hepatic or renal impairment. scored film-ctd tabs. resp. 5mg-28, A5.93; 10mgC b -blockers, digitalis. 28, A6.65. A Bradycardia, 1st degree AV block, ankle S Hypertension oedema, nausea, headache, rash. P 5-20mg once daily. Usually 10mg daily. Q Not recommended. EUCARDIC Roche D See 2.4, b-blockers Drug Presc. Notes.
EMCOR
3MO Daiichi Sankyo/Merck Serono
3MO Cardioselective b-blocker. Bisoprolol fumarate 5mg, 10mg. Yellow and orange biconvex film-ctd heart-shaped scored tabs. 5mg-28, A5.94; 10mg28, A6.68. 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 2MO
a/b-blocker. Carvedilol 12.5mg peach scored tab. marked BM H3; 25mg off-white scored tab. marked BM D5. 12.5mg-28 (Cal/Pk), A7.96; 25mg28 (Cal/Pk), A9.54. S Hypertension. P Initially, 12.5mg once daily for two days then 25mg once daily. If necessary titrate at two week intervals to max. 50mg once daily or in divided doses. Q Under 18 years, not recomennded. D See 2.4, b-blockers Drug Presc. Notes. NYHA class IV decompensated HF requiring IV inotropic support, liver dysfunction. Contains lactose.
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Novartis
Rowex 2 M O
Ca++ antagonist/AII antagonist. Amlodipine (as
AAdverse Reaction â&#x20AC;˘ DContraindications â&#x20AC;˘ BSpecial precautions â&#x20AC;˘ CDrug interactions
51
2.4 HYPERTENSION
CIRCULATORY SYSTEM
amlodipine besylate) / valsartan 5mg/80mg, 5mg/ 160mg, 10mg/160mg. Film-ctd tab, imprinted with NVR on one side. 5mg/80mg: Dark yellow, round with bevelled edges, with NV on other side. 5mg/ 160mg: Dark yellow, oval with ECE on other side. 10mg/160mg: Light yellow, oval with UIC on other 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. Mild to moderate hepatic impairment without cholestasis, max. valsartan 80mg. C Lithium, drugs increasing K+ levels (avoid). Caution: CYP3A4 inhibitors/ inducers, NSAIDS. A Headache, nasopharyngitis, influenza, oedema, fatigue, flushing, asthenia, hot flush.
May be used alone or in combination with other antihypertensive drugs. P Initially 1mg daily as single dose, adjusting according to response. Max. 4mg daily as single dose. If used with diuretic, discontinue diuretic for 3 days before starting therapy with 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.
four times daily. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.
INNOVACE
MSD
2MO
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, A5.93; 10mg-28, A8.31; 20mg-28, A9.88. 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 2MO (discontinue promptly). Contains lactose. 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 and marked M6, resp. B.D. Starter pack (8 x sympathomimetics, alcohol, gold. A A 500mcg plus 32 x 1mg), 4.49; 500mcg-56, 3.17; 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. FLOLAN GSK Thereafter, increase gradually as required. Max. INNOZIDE MSD 2NO 20mg daily. 5MO + Q Not recommended. Prostaglandin. Epoprostenol 0.5mg, 1.5mg (as Na ACE inhibitor/thiazide diuretic. Enalapril maleate D Sensitivity other quinazolines. salt). Powder and solvent for soln for inf. 0.5mg, 20mg, HCTZ 12.5mg. Yellow fluted scored tab. B Pregnancy, lactation. Initial low dose A122.96; 1.5mg, A198.88. marked MSD 718 on reverse. 28, A16.72. S Long-term IV treatment of primary and and gradual titration is recommended. S Hypertension. C Other antihypertensives. Caution: PDE-5 P Usually 1 once daily. Max: 2 tabs. daily. secondary pulmonary hypertension in the inhibitors. scleroderma spectrum of diseases due to intrinsic Q Not recommended. A Depression, nervousness, dizziness, precapillary pulmonary vascular disease in NYHA D Anuria, aortic/renal artery stenosis, drowsiness, headache, faintness, syncope, loss of functional Class III and Class IV patients. hypertrophic cardiomyopathy, hyperkalaemia. P Short-term dose-ranging, initiate at 2ng/ conciousness, blurred vision, vertigo, palpitations, Hereditary or idiopathic angioedema, history of dyspnoea, nasal congestion, GI disorders, rash, kg/min and increase by increments of 2ng/kg/min angioneurotic oedema. Hypersensitivity to other every 15 mins or longer until max. haemodynamic urinary frequency, oedema, lack of energy, sulphonamide-derived drugs. Acute hypertension. weakness. CHF (no data). Moderate/severe renal impairment. benefit or dose-limiting effects. Long-term Pregnancy, lactation. continuous inf., initiate at 4ng/kg/min less than INDERAL LA AstraZeneca B Volume depletion may cause max. tolerated inf. rate (MTiR) determined during 3 M O symptomatic hypotension. Haemodialysis, renal or short-term dose ranging. If MTiR Q 5ng/kg/min, hepatic impairment, surgery/anaesthesia, diabetes. start long-term inf. at one-half MTiR. Decrease Non-cardioselective b-blocker. Propranolol (HCl) Anaphylactoid reactions during LDL apheresis, gradually in 2ng/kg/min decrements every 15 mins 160mg. Lavender/pink hard prolong.-release cap. hypersensitivity/angioneurotic oedema reported or longer until dose-limiting effects resolve. Avoid marked INDERAL LA 28, A8.41. rarely. Contains lactose. abrupt withdrawal. Infusion rate: See SPC. 3MO C Lithium, antidiabetics, tubocurarine, R Caution. ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. K+suppl. or K+sparing diuretics, allopurinol, Q Limited data. Lavender/pink hard prolong.-release cap. marked cytostatic or immunosuppressive agents, D CHF arising from severe LV dysfunction. HALF-INDERAL LA. 28, A6.13. Do not use chronically in patients who develop S Hypertension. Adjunct in thyrotoxicosis. procainamide, ganglionic or b-blockers, pulmonary oedema during dose-ranging. P Hypertension: 160mg daily increasing if cholestyramine, colestipol, NSAIDs, corticosteroids, ACTH, narcotic drugs/antispsychotics, alcohol, B Monitor BP and heart rate during necessary in 80mg increments until adequate ciclosporin, antacids, sympathomimetics, pressor admin. Pregnancy and lactation (only if essential). response is achieved. Thyrotoxicosis: 80mg or amines, gold. C Caution: Anticoagulants, other 160mg daily. Max. 240mg daily. A Dizziness, fatigue. Muscle cramps, vasodilators, NSAIDs. Q Not recommended. nausea, asthenia, orthostatic effects including A Facial flushing, headache, GI disorders, 3MO hypotension, headache, cough, impotence. jaw pain, dry mouth, lassitude, inf. site reaction, ALSO INDERAL TABLETS Propranolol (HCl) 10mg. chest pain, decreased platelet count, tachycardia, Pink film-ctd tab. marked Inderal 10. 10mg-100, ISOPTIN Abbott bradycardia, anxiety, agitation. A1.20. 2MO S As above and phaeochromocytoma. GOPTEN Abbott P Hypertension: initially 80mg twice daily Class I Ca++ antagonist. Verapamil (HCl) 40mg, 80mg, 120mg. White film-ctd. tabs. 40mg-100, 2MO increasing if necesary at weekly intervals to 160A3.54; 80mg-100, A7.07; 120mg-100, A10.60. ACE inhibitor. Trandolapril 0.5mg red/yellow cap. 320mg daily. Phaeochromocytoma: 60mg daily 2NO 1mg red/orange cap. 2mg red/red cap. 0.5mg-14, with a-blocker for 3 days preoperatively or 30mg A3.05; 1mg-28, A7.49; 2mg-28, A8.84 . ALSO ISOPTIN INJECTION Verapamil 5mg/2ml. daily in inoperable cases. Amp. 5 x 2ml, A6.44. Q 0.25-0.5mg/kg body weight three or S All grades of essential hypertension.
52
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
S Hypertension. As monotherapy or in or amlodipine monotherapy. combination with thiazide diuretics, bP 1 tab. per day. Use 20mg/5mg tab. if BP ++ adrenoceptor blocking agents, Ca antagonists or not adequately controlled by 20mg olmesartan medoxomil or 5mg amlodipine alone. Use 40mg/ ACE inhibitors. 5mg tab. if 20mg/5mg tab. not adequately P Initially 4mg once daily swallowed whole with water; may be increased to max. 8mg controlling BP; if BP still not adequately controlled, use 40mg/10mg tablets. Titration of once daily. individual components recommended before Q Under 12 years, not recommended. switching to fixed combination. D History of GI or oesophageal R Monitor BP closely if max. daily dose of obstruction, or any degree of decreased lumen 40mg olmesartan medoxomil required. diameter of the GI tract. Pregnancy (only if Q Under 18 years, not recommended. benefit outweighs risk), lactation. D Severe hepatic insufficiency, biliary B Caution: Impaired hepatic function. Introduction and adjustment. Initial dose: Excessive obstruction. Cardiogenic shock. Acute MI (within ISOPTIN SR Abbott hypotensive effect may occur. Driving or operating first 4 weeks). Unstable angina pectoris. Pregnancy, lactation. machinery. Contains lactose. 2MO B Correct volume and/or Na+ depletion C Caution: PDE-5 inhibitors. Class I Ca++ antagonist. Verapamil 240mg. Light A Palpitation, tachycardia, vertigo, GI before treatment. Not recommended: primary green oblong film-ctd sust.-release tab. 28, disorders, asthenia, chest pain, peripheral oedema, aldosteronism. Caution: Severe CHF, underlying A12.67. back pain, myalgia, dizziness, headache, coughing, renal disease incl. renal artery stenosis, impaired S Mild to moderate hypertension. bronchitis, pruritus, urinary incontinence, cystitis, renal function, moderate hepatic impairment, P 1 daily. postural hypotension. aortic or mitral valve stenosis, obstructive R v in the morning increasing by v at hypertrophic cardiomyopathy. May occur: weekly intervals according to response. KONVERGE A. Menarini / Daiichi Sankyo Hyperkalaemia, pulmonary oedema (NYHA III and Q Not recommended. IV heart failure patients), MI, stroke. No data: 2MO D See Isoptin. Recent kidney transplant, end-stage renal Angiotensin II antagonist/ Ca++ antagonist. impairment. ISTIN Pfizer Olmesartan medoxomil / amlodipine (as besilate), C Not recommended: K+ supplements, 20mg/5mg, 40mg/5mg, 40mg/10mg. Round, film2MO + + coated tablets. Resp. white, cream or brownish-red salts containing K , K sparing diuretics, heparin, Ca++ antagonist. Amlodipine besylate 5mg, 10mg. ACE inhibitors, lithium. Caution: Other debossed with C73, C75 or C77 on one side. 20mg/ White emerald-shaped tabs. marked AML-5 or antihypertensives, NSAIDs, CYP3A4 inhibitors/ 5mg-28, A20.20; 40mg/5mg-28, A24.42; 40mg/ AML-10 resp. and Pfizer on reverse. 5mg-28, inducers. 10mg-28, A25.73. A9.21; 10mg-28, A13.76. A Dizziness, headache, oedema, fatigue. S Essential hypertension if BP not S Hypertension. adequately controlled on olmesartan medoxomil P Initially 5mg daily, increasing to max. 10mg. Q Not recommended. B Impaired liver function. Pregnancy, lactation. Classifications A Oedema, headache, flushing, dizziness, 2........This medicinal product is permitted for use in sport. nausea, palpitations, fatigue, abdominal pain, 5........ This medicinal product contains substance(s) prohibited for somnolence. S Mild to moderate hypertension. P 80-160mg three times daily. Q Up to 10mg/kg body weight daily in divided doses. 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 myocardial infarction. Bradycardia. C b-blockers, quinidine or digoxin. A Constipation, headache, flushes.
Anti-doping: A Guide for Prescribers
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.
use in sport. Athletes requesting to use this product are required to apply for a TUE. m.. This medicinal product contains substance(s) prohibited for use in sport, in men only. Male Athletes requesting to use this product are required to apply for a TUE. c. This medicinal product contains substance(s) prohibited for use in sport during the competition period only. Athletes requesting to use this product in-competition are required to apply for a TUE. 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. d.....This medicine is permitted but should be declared on the Doping Control Form at the time of testing. 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.
Despite granting of 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
53
2.4 HYPERTENSION
CIRCULATORY SYSTEM
if desired therapeutic effect not obtained within 2-4 weeks, may be increased to 80mg/day max. Patients on diuretics: If possible, withdraw diuretic ACE inhibitor/Ca++ antagonist. Enalapril maleate/ 2-3 days before starting treatment; if not possible, lercanidipine hydochoride 10mg/10mg, 20mg/ start with 5mg/day, monitor serum K+ and renal 10mg. Resp. white and yellow biconvex, round function. Renal impairment, ccQ10ml/min, initially film-ctd tabs. 10mg/10mg-28, A16.08; 20mg/10mg- 2.5mg; 10QccQ30ml/min, initially 2.5-5mg; 28, A18.30. 31QccQ80ml/min, initially 5-10mg/day. S Essential hypertension not adequately Q Not recommended. controlled by lercanidipine 10mg alone. Not for D History of angioedema associated with initial treatment of hypertension. previous ACE inhibitor therapy. Hereditary or P Individual dose titration recommended. idiopathic angioedema. Pregnancy, lactation. Direct switch from monotherapy may be B Caution: Acute MI (do not use: Renal considered. 1 tab. once a day at least 15 min dysfunction, systolic BP R100mmHg, cardiogenic before meals, preferably in the morning. shock), mitral stenosis and left ventricle outflow R Adjust dose based on renal function. obstruction (aortal stenosis, hypertrophic Q Under 18 years, not recommended. myocardiopathy), bilateral renal artery stenosis or D Left ventricular outflow obstruction, stenosis of the artery in a single kidney (strict including aortic stenosis. Untreated congestive supervision with low doses; careful dose heart failure. Unstable angina pectoris. Within 1 adjustment), pre-existing renal impairment month of a myocardial infarction. Severe renal (monitor blood K+, creatinine), major surgery, impairment (ccQ30ml/min), including patients anaesthesia, renal insufficiency, diabetes. May undergoing haemodialysis. Severe hepatic occur: Systemic hypotension, angioedema impairment. Concomitant strong CYP3A4 (withdraw immediately if occurs), anaphylactoid inhibitors, cyclosporin and grapefruit juice. History reactions in haemodialysis patients or during of angioedema caused by previous therapy with desensitisation treatment, acute renal insufficiency an ACE-inhibitor. Hereditary or idiopathic in patients with HF (usually reversible), hepatic angioedema. Pregnancy, lactation. insufficiency, neutropenia/agranulocytosis, cough. B Adjust diuretic dose in HF patients as C Not recommended: Lithium. Caution: symptomatic hypotension may occur. Caution: Diuretics, K+-sparing diuretics, K+ containing Sick-sinus syndrome, left ventricular dysfunction, supplements and salts, NSAIDs (incl. acetylsalicylic ischaemic heart disease, mild to moderate renal acid r 3g/day), other antihypertensives, injectable impairment, bilateral renal artery stenosis or single gold, certain anaesthetic drugs, TCAs, artery stenosis, hepatic dysfunction, diabetes, antipsychotic agents, sympathicomimetics, antisurgery/anaesthesia. Not recommended after diabetics. recent renal transplantation. May occur: A Dizziness, headache, cough, diarrhoea, Neutropenia/agranulocytosis, thrombocytopenia vomiting, renal dysfunction, orthostatic effects and anaemia, hypersensitivity/angioneurotic (incl. hypotension). oedema, anaphylactoid reactions during LDLapheresis with dextran sulphate, hyperkalaemia. LISOPRESS Niche C Contra: CYP3A4 inhibitors, cyclosporine, 2 M O grapefruit juice. Not recommended: K+-sparing ACE inhibitor. Lisinopril 2.5mg, 5mg white scored diuretics, K+ supplements, lithium, estramustine, tabs. marked 2.5 or 5; 10mg white square tab. CYP3A4 substrates, digoxin. Caution: Antidiabetics, scored one side and marked 10; 20mg white thiazides, loop diuretics, NSAIDs, baclofen, pentagonal tab scored and marked 20. 2.5mg-28, amifostine, TCAs, neuroleptics, anaesthetics, A4.63; 5mg-28, A7.11; 10mg-28, A8.77; 20mg-28, narcotics, corticosteroids, tetracosactide, other A9.59. antihypertensives, allopurinol, cytostatic or S Arterial hypertension. immunosuppressive agents, systemic corticosteroids P Initially 5mg in the morning increasing or procainamide, antacids, symphthomimetics, to maintenance 10-20mg daily. A lower dose acetylsalicylic, injectable gold, midazolam, 2.5mg in the morning in renal dysfunction, HF, cimetidine, simvastatin. Avoid alcohol. patients who do not tolerate discontinuation of A Dizziness, vertigo, cough, diuretics, volume and/or salt depletion, severe or hypersensitivity, angioedema, depression, renovascular hypertension, elderly. dizziness, headache, blurred vision, myocardial Q Not recommended. infarction, arrhythmia, angina pectoris, D Pregnancy, lactation. Renal artery tachycardia, hypotension, syncope, cerebrovascular stenosis, severe renal impairment, accident, cough, dyspnoea, nausea, diarrhoea, haemodynamically relevant aortic or mitral valve abdominal pain, dysgeusia, rash, asthenia, fatigue, stenosis, haemodynamically unstable patients after chest pain, increased blood K+, increased blood acute MI. creatinine. B Haemodialysis. Hypotension, unstable
LERCARIL
Recordati
2MO
cardiac failure, renal impairment, renovascular hypertension, primary hyperaldosteronism, 2MO proteinuria, angioneurotic oedema, aortic stenosis, ACE inhibitor Lisinopril 2.5mg, 5mg, 10mg, 20mg. surgery/anaesthesia. Round tabs, can be divided in equal halves. 2.5mg: C K+ sparing diuretics, K+ suppl., diuretics, Na+, Cl, antihypertensive agents, analgesics, antiWhite, biconvex. 5mg: White, flat, scored both sides. 10mg: Light pink, biconvex, scored one side. inflammatory agents, lithium, alcohol, anaesthetics, hypnotics, narcotics, 20mg: Pink, biconvex, scored one side. 2.5mg-28, A5.06; 5mg-28, A7.18; 10mg-28, A8.84; 20mg-28, sympathomimetics, antacids. A10.16. A Hypotension, dizziness, weakness, impaired vision, syncope, tachycardia, palpitations, S Hypertension. arrhythmias, chest pain, angina. P Initially, 10mg. Patients with highly activated reninangiotensin-aldosterone system: Rowex 2.5-5mg initially. Maintenance, 20mg (single dose); LISPRIL
LESTACE
54
Actavis
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
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, A5.29; 2.5mg-28, A7.48; 5mg-28, A10.41; 10mg-28, A14.13. 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.
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
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.
LONITEN
Pharmacia
2MO Vasodilator. Minoxidil 5mg. White tab. marked with tab. strength one side, scored and marked U above and below score on reverse. 60, A15.11. S Severe hypertension that is symptomatic or associated with target organ damage. Hypertension not controlled adequately by a combination of a diuretic and a sympathetic suppressant. Hypertension not manageable with max. therapeutic doses of a diuretic plus two other antihypertensives. P Initially 5mg daily in single or divided doses, increase at three day intervals, if necessary to 20mg daily and then to 40mg daily; usual max. 50mg daily. R Initially 2.5mg daily, then as per adults. Q Initially 0.2mg/kg body weight daily in single or divided doses increase, at three day intervals, by 0.1-0.2mg/kg body weight daily. Max. 1mg/kg body weight daily. D Phaeochromocytoma. Lactation. B MI. Diuretics and sympathetic suppressants must be given concurrently. Renal impairment. Multiple reports of pericarditis. Pericardial effusion and tamponade have been reported. Thrombocytopenia and leukopenia have been rarely reported. Pregnancy. C Sympathetic-blocking agents e.g. guanethidine or bethanidine may produce excessive blood pressure reduction and/or orthostasis. A Hypertrichosis, oedema, tachycardia.
LOW CENTYL K
LEO Pharma
5MO Thiazide/K+suppl. Bendrofluazide 1.25mg, K+ Cl 573mg (7.7mmol K+). Yellow, sug-ctd, oval, modified release tab. 250, A17.62. S Hypertension alone or in combination with other antihypertensives. P 1 daily. Q Not recommended. 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.
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
55
2.4 HYPERTENSION
CIRCULATORY SYSTEM
Q Not recommended. D Cholestasis and biliary obstructive disorders, severe hepatic or renal impairment, refractory hypokalaemia, hypercalcaemia. Hypersensitivity to sulphonamide derivatives. Pregnancy, lactation. METOCOR Rowex B Not recommended: Primary aldosteronism. Caution: Hepatic impairment, 3MO progressive liver disease, mild to moderate renal Cardioselective b-blocker. Metoprolol tartrate 50mg, 100mg. White tabs. scored one side. 50mg- impairment (monitor renal function), renal artery stenosis (renovascular hypertension risk), renal 100, A3.50; 100mg-100, A6.50. S Hypertension. Adjunct in thyrotoxicosis. transplantation, RAA system stimulation (severe CHF, renal disease), aortic or mitral valve stenosis, P Hypertension: initially 100mg daily obstructive hypertrophic cardiomyopathy, increasing to 400mg daily in single or divided diabetes, history of hypersensitivity or bronchial doses. Thyrotoxicosis: 50mg four times daily. asthma. Correct volume/ Na+ depletion before Q Not recommended. starting therapy. Monitor serum electolytes. May D See 2.4, b-blockers Drug Presc. Notes. 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 sorbitol. strength one side, G on reverse. 50mg-100, A3.50; C Drugs affecting serum K+ levels, digitalis 100mg-100, A6.51. glycosides, drugs inducing torsades de pointes, S Hypertension. Adjunct in thyrotoxicosis. 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, cyclosporin, tetracyclines, alcohol, anaesthetics, MICARDIS Boehringer Ing. 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 20A A 80mg once daily. Severe renal impairment: Initially one side. 5mg-28, 8.28; 10mg-28, 12.38. 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 Angiotensin II antagonist/thiazide diuretic. S Essential hypertension. Telmisartan/HCTZ 40mg/12.5mg, 80mg/12.5mg, P 1 daily. 80mg/25mg. Resp. red and white, red and white, D Severe renal failure. Hepatic yellow and white tabs. with company logo and encephalopathy or severe liver impairment. A coded H4, H8 and H9. 40/12.5mg-28, 19.16; 80/ Hypokalaemia. 12.5mg-28, A23.14; 80/25mg-28, A28.45. B Impaired liver function. Monitor plasma 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. A Rash, photosensitivity, myopia aggravation, blood dyscrasias, gout, fatigue. Acute pancreatitis, hyperuricaemia, GI upset, oliguria, dizziness, headache, muscle pain, thirst, dry mouth. Vasculitis.
56
Monitor blood glucose in diabetics. Monitor uric acid; risk of gout in hyperuricaemic patients. Renal insufficiency. Pregnancy, lactation, avoid. C Not recommended: Lithium. Caution: Torsades de pointes-inducing drugs, NSAIDs, ACE inhibitors, other agents causing hypokalaemia, baclofen, digitalis preparations. Combinations to be taken into consideration: K+ sparing diuretics, metformin, iodinated contrast media, imipraminelike antidepressants, neuroleptics, Ca++ salts, cyclosporin, tacrolimus, corticosteroids, tetracosactide.
NATRILIX SR
Servier
5MO Antihypertensive diuretic. Indapamide hemihydrate 1.5mg. White sust.-release coated tab. 30, A5.41. 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,
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
S Essential hypertension. P Optimal dose, 20mg once daily. Initially, 10mg once daily. Max.: 40mg daily. Take at same time each day. Effect present within 2 weeks and max. by about 8 weeks. Mild to moderate renal impairment: Max 20mg once daily. Moderate hepatic impairment: Max 20mg once daily. Q 18 years and under, not suitable (limited experience). D Pregnancy, lactation. Biliary obstruction. B Intravascular volume depletion (risk of symptomatic hypotension). Caution: bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney, impaired renal function (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. Initially 10mg once daily, max 20mg once daily; cyclosporine, tacrolimus, vincristine, antidiabetics, D See 2.4, b-blockers Drug Presc. Notes. Monitor BP and renal function. qinidine, cisapride. Avoid grapefruit juice. ODRIK Abbott Q Under 18 years, not recommended. A Headache, facial reddening, D Severe renal impairment. Severe hepatic palpitations, dizziness, leg oedema. 2MO impairment, cholestasis and biliary obstructive ACE inhibitor. Trandolapril 0.5mg, 1mg, 2mg. Red/ disorders. Refractory hypokalaemia, NIFTEN AstraZeneca yellow, red/orange and red/red caps. marked with hypercalcaemia, hyponatraemia and symptomatic 3MO cap. name, logo and strength. 0.5mg-28, A 6.10; hyperuricaemia. Pregnancy, lactation. 1mg-28, A7.49; 2mg-28, A8.84. Cardioselective b-blocker/Class II Ca++ antagonist. B Caution: Intravascular volume depletion S All grades of hypertension. Atenolol 50mg, sust.-release nifedipine 20mg. (risk of symptomatic hypotension), bilateral renal P Starting dose, 1mg once daily, adjust Reddish brown cap. marked NIF-TEN. 28, A12.96. 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 A Cough, headache, asthenia, dizziness. arterial circulatory disturbances, 2nd or 3rd degree history of allergy or bronchial asthma). Nausea, hypotension. Allergic hypersensitivity heart block, sick sinus syndrome, untreated Exacerbation or activation of systemic lupus erythematosus reported with thiazide diuretics. phaeochromocytoma, uncontrolled HF, pregnancy, reactions. Rarely angioneurotic oedema. Not recommended: Recent kidney transplant, lactation, severe aortic stenosis, marked renal OMESAR A. Menarini primary aldosteronism. Monitor serum electrolytes impairment (ccQ 15 ml/min). 2 M O regularly. Contains lactose. B Controlled HF. Conduction defects or st Angiotensin II antagonist. Olmesartan medoxomil C Not recommended: K+ suppl., K+ sparing poor cardiac reserve. Prinzmetal’s angina, 1 10mg, 20mg, 40mg. White film-ctd tabs. with C13, diuretics, lithium. Caution: Amifostine, alcohol, degree heart block. May aggravate less severe C14, C15 resp. embossed on one side. 10mg-28, barbiturates, narcotics, antidepressants, NSAIDs, peripheral arterial circulatory disturbances. May A14.74; 20mg-28, A17.70; 40mg-28, A22.29. other antihypertensives, baclofen, Ca++ salts, modify tachycardia of hypoglycaemia. May mask 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, iodine products (high doses), cytotoxic agents, barbiturates, narcotics, anionic exchange resins. See also: 2.4 b-blockers Drug Presc. Notes. A See SPC.
thyrotoxicosis. Will reduce heart rate. Do not discontinue abruptly in ischaemic heart disease. History of anaphylactic reaction to allergens. Asthmatics, diabetes, clinically significant liver disease. Discontinue if ischaemic pain occurs. Use in men in in vitro fertilisation. C Contra: Ca++ channel blockers with negative inotropic effects (e.g. verapamil, diltiazem), rifampicin. Grapefruit juice, not recommended. Caution: Other dihydropyridines, digitalis glycosides, clonidine, class 1 antiarrhythmics (e.g. disopyramide), amiodarone, sympathomimetics, prostaglandin synthetaseinhibiting drugs, anaesthetics, cimetidine. A Oedema, dizziness, headache, GI disturbance, purpura, impotence, fatigue.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
57
2.4 HYPERTENSION
CIRCULATORY SYSTEM
days before). May be increased to 8mg once daily after one month. Renal impairment: Based on cc (see SPC). R 2mg daily, may be progressively increased to 4mg after one month then to 8mg if necessary depending on renal function (see SPC). Q Not recommended. D Angioedema, history of ACEI related angioedema. Pregnancy, lactation. B Symptomatic hypotension may occur. PENDREX Rowex Correct salt depletion / hypovolaemia, if possible, prior to therapy. Monitor renal function and 2MO serum K+ before and during treatment. Caution: ACE inhibitor. Perindopril tert-butylamine 2mg, Severe HF impaired renal function, tendency for 4mg, 8mg. White, round, biconvex tablet electrolyte disturbance, mitral valve stenosis, debossed with 2, 4 or 8 on one side. 2mg-30, obstruction in the outflow of the left ventricle, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. collagen vascular disease, anaesthesia (discontinue S Hypertension. P In monotherapy or in combination with one day prior to surgery), patients at risk of hyperkalemia. May occur: Unstable angina pectoris other antihypertensives. Initially 4mg once daily in the morning, may be increased to 8mg/day after 1 (re-evaluate), jaundice, angioedema (promptly discontinue), anaphylactoid reactions (interrupt month. Patients with a strongly activated reninduring LDL aphaeresis or desensitisation). Contains angiotensin-aldosterone system: Initially 2mg/day lactose. under supervision. Discontinue diuretics 3 days C Not recommended: Lithium, K+-sparing beforehand; if not possible, commence with 2mg diuretics, K+ suppl, diuretics. Caution: and monitor renal function and serum K+. Renal Immunosuppressant, allopurinol or procainamide, impairment: See SPC. oral antidiabetics, NSAIDs, vasodilators, certain R Initially 2mg, may be progressively anaesthetics, TCAs, antipsychotics, increased to 4mg after 1 month then to 8mg sympathomimetics. depending on renal function. A Headache, dizziness, vertigo, Q Not recommended. paresthaesia, vision disturbance, tinnitus, D History of angioedema associated with hypotension, cough, dyspnoea, GI disorders, rash, previous ACE inhibitor therapy. Hereditary or pruritus, muscle cramps, asthenia. idiopathic angioedema. Pregnancy, lactation. B If unstable angina pectoris occurs in 1st PLENDIL AstraZeneca month, reappraise benefit/risk before continuing 2NO treatment. Volume depletion, symptomatic HF Class II Ca++ antagonist. Felodipine 2.5mg, 5mg, may cause symptomatic hypotension. Caution: 10mg. Sust.-release film-ctd tabs. marked A/FM Mitral valve stenosis, aortic stenosis, hypertrophic orA/FE. 2.5mg-28, A7.34; 5mg-28, A9.49; 10mg-28, cardiomyopathy, collagen vascular disease, A12.76. immunosuppressant therapy, treatment with S All grades of hypertension. allopurinol or procainamide, diabetes. Renal P Initially 5mg once daily adjust if impairment: Adjust dosage according to cc and necessary. Maintenance 5-10mg once daily. Max. response to treatment. Anaphylactoid reactions 20mg daily. may occur during dialysis with high flux Q Not recommended. membrane or low-density lipoproteins apheresis with dextran sulphate. Discontinue if angioedema D Pregnancy, lactation. occurs. May occur: Hepatic syndrome, neutropenia/ B Severe hepatic insufficiency, recent myocardial ischaemia. agranulocytosis, thrombocytopenia, anaemia, C Cimetidine, phenytoin, carbamazepine, persistent non-productive cough, elevation in + phenobarbitone. serum K . Discontinue 1 day prior to surgery. C Avoid: Diuretics, K+ sparing diuretics, K+- A Ankle oedema, dizziness, fatigue, headache, flushing, palpitations, rash, mild containing salt substitutes, K+ supplements, gingival enlargement. lithium. Caution: NSAIDs, other antihypertensives and vasodilators, antidiabetics, TCAs, PRESTIM Meda antipsychotics, anaesthetics, sympathomimetics, antacids. 5NO A Headache, dizziness, vertigo, b-blocker/thiazide. Timolol maleate, 10mg; paresthaesia, vision disturbance, tinnitus, bendroflumethiazide, 2.5mg. White, flat, petalhypotension and related effects, cough, dyspnoea, shaped tab. with ICN on 1 side and 132 and score GI disturbances, rash, pruritus, asthenia. line on the other. 30, A4.89; 100, A4.89. S Hypertension. PERCARNIL Actavis P Initially 1 tab. daily. May be increased 2MO after 2 weeks to 2 tab. max. Recommended dose ACE inhibitor. Perindopril (tert-butylamine salt) 1-2 tabs/day either as single dose in morning or 4mg, 8mg. White tabs, PP marked on one side and divided doses morning and evening. If BP control strength on reverse. 4mg oblong with a break-line not achieved on 2 tab/day, consider titrating on both sides; 8mg circular. 4mg-30, A9.92; 8mgtimolol and bendroflumethiazide separately or 30, A16.29. adding another hypotensive. Hepatic failure: May S Hypertension. require dose adjustment. P As monotherapy or in combination with D Asthma/history of asthma, 2nd and 3rd other anti-hypertensives. Initially 4mg once daily degree atrioventricular block, severe bradycardia, in the morning or 2mg daily in patients with uncontrolled or digitalis/diuretic refractory HF, strongly activated renin-angiotensin-aldosterone cardiogenic shock, digitalis intoxication or system or on diuretics (if possible discontinue 2-3 hypokalaemia, precoma associated with hepatic, cholestyramine/colestipol resins, digitalis glycosides, class Ia and III antiarrhythmics, some antipsychotics, non-depolarizing skeletal muscle relaxants, anticholinergics, antidiabetics, bblockers, diazoxide, pressor amines, probenecid, sulfinpyrazone, allopurinol, amantadine, cytotoxic agents, salicylates, methyldopa, cyclosporine, tetracyclines. A Dizziness, fatigue. See SPC.
58
renal or Addisonsâ&#x20AC;&#x2122; disease. Pregnancy, lactation (unless essential). B Discontinue if marked bradycardia develops. Caution: Controlled CHF (discontinue if deteriorates), elderly, family history of asthma, impaired hepatic or renal function, potential urinary tract obstruction, disorders rendering electrolyte balance precarious, uncontrolled or brittle diabetes. May mask symptoms of thyrotoxicosis and hypoglycaemia. Ocular changes may occur (conjunctivitis, dry eye; consider discontinuation). Monitor fluid and electrolytes. Withdraw gradually. C Contra: Lithium salts, verapamil or other 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. S Essential hypertension. P 1 daily in the morning before a meal. Double dose if necessary. Q Not recommended. D Hereditary/idiopathic angioneurotic oedema. Severe renal failure or impaired hepatic function, hypokalaemia. Pregnancy, lactation. B Electrolyte imbalance, diabetes, gout, hypotension, cardiac or renal failure, atherosclerosis, renal artery stenosis, elderly, immunosuppressed patients, hepatic impairment, haemodialysis. C Lithium, K+ -sparing diuretics, K+ salts, non antiarrhythmic drugs which cause torsade de pointes, anaesthetics, cytostatic or immunosuppressive agents. A Asthenia, dizziness, headache, mood swings, sleep disturbances, cramps, hypotension, allergic reactions, skin rashes, GI disorders, anorexia, nausea, dry cough, dry mouth, risk of dehydration in elderly and heart failure, altered blood test results. Rarely angioneurotic oedema, haematological disorders.
PRINDACE
Clonmel
2MO ACE inhibitor. Perindopril tert-butylamine 4mg, 8mg. 4mg-30, A12.07; 8mg-30, A19.27. S Hypertension. P Initially, 4mg once daily in the morning before food in monotherapy or in combination. May be increased to 8mg once daily after one month. Strongly activated RAA system: Initially 2mg daily. Renal impairment, see SPC. R Initially 2mg daily; may be progressively increased to 4mg after one month then to 8mg if necessary depending on renal function. Q Under 18 years, not recommended. D Angioedema. Pregnancy, lactation. B Increased risk of symptomatic
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
A10.92. S Hypertension. P Without diuretics and without CHF, initially 2.5mg once daily. Increase dose incrementally at intervals of 1-2 weeks up to max 10mg once daily. Usual effective dose: 2.5-10mg. Combination treatment recommended if response unsatisfactory at 10mg. Diuretic-treated patients, discontinue diuretic 2-3 days before initiating. 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, 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 2 M O caps. with light grey body and light green, green, 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 28, A11.54. Yellow marked R2. 5mg: Pink marked R3. 10mg: with dextran sulphate. S Hypertension. White marked R4. 2.5mg-28, A5.80; 5mg-28, 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 cutaneous and mucosal reactions, vasculitis, muscle prior to therapy. If diuretic cannot be 10mg not effective. Hypertension with HF: Initially and joint pains, fever or eosinophilia, dry tickling discontinued, start with 1.25mg. Renal impairment: 1.25mg once daily. On diuretics: Discontinue cough, disturbances of balance, nervousness, See SPC. diuretic 2-3 days before therapy (or earlier if longrestlessness, 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 S Essential hypertension. disturbances, dry tickling cough, skin/mucosal symptomatic hypotension; monitor closely. P 150mg once daily with light meal, reactions, sinusitis, bronchitis, conjunctivitis, hair Surgery/anaesthesia. Bone marrow depression, preferably same time each day; may be increased loss. hyperkalaemia, angioneurotic oedema have been to 300mg once daily. Effect substantially present reported. Contains lactose. Driving/using machines. within 2 weeks. Use alone or in combination with RAMILO Rowex C Caution: K+ sparing diuretics, K+ other antihypertensives. supplements, diuretics, nitrates, other vasodilators, 2MO Q Under 18 years, not recommended. heparin, alcohol, allopurinol, procainamide, ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, D Concomitant use with ciclosporin and cytostatics or immunosuppressants, trimethoprim, 10mg. White, oblong, biplane with facet tabs. other potent P-gp inhibitors (quinidine, antidiabetics, sympathomimetics, NSAIDs. Avoid 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. pregnancy. A Dizziness and headache, orthostatic 2.5mg-30, A6.21; 5mg-30, A8.65; 10mg-30, B Volume- and/or salt-depleted patients, effects, diarrhoea, vomiting, cough, renal A11.78. supervise closely. Caution in: Severe heart failure, impairment. S Hypertension. severe renal dysfunction, renal artery stenosis, history of dialysis, nephrotic syndrome, or P Initially 2.5mg once daily swallowed RAMYTE Actavis renovascular hypertension. Increased risk of whole with plenty of liquid. May be increased at hyperkalaemia in patients treated with RAS intervals of 2-3 weeks to 5mg, then to max. 10mg 2 M O agents, reduced kidney function, diabetes mellitus. ACE inhibitor Ramipril 2.5mg, 5mg, 10mg. Size 4 once daily, or to max. 5mg once daily if Persistent diarrhoea, discontinue. hard cap. containing white powder, with light concomitant diuretic or Ca+channel blocker is C Caution: Furosemide, drugs that may grey body and resp. light green, green or dark used. Concomitant diuretic treatment/ increase serum K+, digoxin, irbesartan, meals with green cap, marked R on cap and strength on nephropathy: Initially 1.25mg once daily. Renal 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. John’s wort,
Max. 2.5mg daily. Q Not recommended. D Angioedema, history of angioedema with previous ACE inhibitor therapy. Pregnancy, lactation. B If possible, discontinue diuretic treatment 2-3 days before therapy initiation. Volume depletion may cause symptomatic hypotension. Caution: LV valvular and outflow tract obstruction, renal impairment, renal artery stenosis, haemodialysis patients, surgery. Discontinue if jaundice occurs. Driving/ operating machines. 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.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
59
2.4 HYPERTENSION
CIRCULATORY SYSTEM
Q Not recommended. D Lactation, pregnancy (unless clearly necessary). B Heart failure, hepatic impairment. RASILEZ HCT Novartis A Somnolence, dizziness, headache, palpitations, flushing, abdominal pain, nausea, 5MO oedema, fatigue. Renin inhibitor/Thiazide. Aliskiren (as hemifumarate)/HCTZ, 150mg/12.5mg; 150mg/25mg; SELECTOL sanofi-aventis 300mg/12.5mg; 300mg/25mg. Biconvex, ovaloid 3MO film-ctd tab. marked NVR on one side. 150mg/ 12.5mg: White, marked LCI on other side. 150mg/ Vasodilating cardioselective b-blocker. Celiprolol 25mg: Pale yellow, marked CLL on other side. (HCl) 200mg yellow heart-shaped tab.; 400mg 300mg/12.5mg: Violet white, marked CVI on other white heart-shaped tab. Both marked with logo side. 300mg/25mg: Light yellow marked CVV on one side and 200 or 400 on reverse. 200mg-28 other side. 150mg/12.5mg-28, A23.34; 150mg/ (Cal/Pk), A12.08; 400mg-28 (Cal/Pk), A15.11. 25mg-28, A23.72; 300mg/12.5mg-28, A30.29; S Mild to moderate hypertension. A P 200mg once daily. In case of inadequate 300mg/25mg-28, 30.62. S Essential hypertension: In patients with response, increase to 400mg once daily taken one BP not adequately controlled on aliskiren or HCTZ hour before or two hours after meals. Q Not recommended. alone or as substitution therapy in patients D See 2.4, b-blockers Drug Presc. Notes.. adequately controlled with aliskiren and HCTZ, Acute HF or during episodes of HF given concurrently, at same dose as combination. P 1 tab. daily with a light meal, preferably decompensation requiring IV inotropic therapy. at same time. Max effect seen within 4 weeks. SOPROL Helsinn Birex Adjust dose according to clinical response, up to max 300mg/25mg. 3MO Q Under 18 years, not recommended. Cardioselective b-blocker. Bisoprolol fumarate D History of angioedema with aliskiren. 5mg, 10mg. White film-ctd tabs. marked Pregnancy, lactation. Severe renal impairment. BISOPROLOL and tab. strength on one side. 5mgRefractory hypokalaemia, hypercalcaemia. Severe 28, A5.75;10mg-28, A6.43. hepatic impairment. S Hypertension. B Correct volume- and/or salt-depletion P 5-20mg once daily, usually 10mg once before treatment. Caution: Serious CHF (NYHA daily. class III-IV), impaired hepatic function, progressive Q Not recommended. liver disease, aortic or mitral stenosis, obstructive D See 2.4, b-blockers Drug Presc. Notes. hypertrophic cardiomyopathy, renal artery Acute HF or during episodes of HF stenosis, or stenosis to solitary kidney (discontinue decompensation requiring IV inotropic therapy. if renal failure occurs). Discontinue if angioedema C See 2.4, b-blockers Drug Presc. Notes. occurs. May occur: Electrolyte imbalance, Avoid: Floctafenine, sultopride. Caution: hyperuricaemia, precipitation of frank gout, SLE Rifampicin, baclofen, iodated contrast products, exacerbation or activation. Increased risk of mefloquine, corticosteroids. hypokalaemia: Liver cirrhosis, brisk diuresis, SOTACOR BMS inadequate oral electrolyte intake, concomitant corticosteroids / adrenocorticotropic hormone. 3MO Increased risk of hyperkalaemia: Concomitant RAS Non-cardioselective b-blocker. Sotalol (HCl) 80mg, agents, reduced kidney function, diabetes mellitus. 160mg. Both white tabs. scored on one side and Discontinue before carrying out tests for tab. strength marked on other side. 80mg-28, parathyroid function. Persistent diarrhoea, A2.67; 160mg-28, A5.26. discontinue. Contains lactose, wheat starch. S Prevention of myocardial infarction. C Contra: Ciclosporin and other potent P- Cardiac arrhythmias. Angina. Hypertension. gp inhibitors (quinidine, verapamil). Caution: K+ P Reinfarction: 320mg once daily, starting sparing diuretics, K+ supplements and salts , other 5-14 days after infarction. Arrhythmias: Initial dose products that may increase serum K+ levels (e.g. 80mg either singly or as 2 divided doses. Allow 2-3 heparin Na+), digitalis glycosides, antiarrhythmics, days between increments. Most respond to dose other antihypertensives, moderate P-gp inhibitors, of 160-320mg admin. in 2 divided doses at 12 hr furosemide, NSAIDs, meals with high fat content, intervals. In renal impairment; cc q60ml/min: lithium, alcohol, antidiabetics, anionic exchange Normal dose; cc 30-60ml/min: Half normal dose; cc resins, pressor amines, antigout medications, Ca+ 10-30ml/min: Quarter normal dose; cc Q10ml/min: supplements or Ca+-sparing products (e.g. vitamin Avoid. D therapy), curare derivatives, b-blockers, Q Not recommended. diazoxide, anticholinergics, amantadine, cytotoxic D See 2.4, b-blockers Drug Presc. Notes. products (e.g. cyclophosphamide, methotrexate). Prolonged QT interval, torsades de pointes, renal Avoid grapefruit juice. failure. A Diarrhoea. B Caution: Pre-existing arrhythmias, QT interval q 550msec. Electrolyte disturbances esp. RUSTIN Helsinn Birex hypokalaemia or hypomagnesaemia. Caution: Left ventricular dysfunction, recent MI. See b-blockers 2MO Prescribing Notes. See 2.4, b-blockers Drug Presc. Ca++ antagonist. Amlodipine 5mg, 10mg (as amlodipine besilate). White, round, slightly arched Notes. tabs. marked with AB 5 or AB 10 resp. 10mg tab. TENORET 50 AstraZeneca is scored. 5mg-28, A7.34; 10mg-28, A10.97. 5MO S Essential hypertension. Cardioselective b-blocker/thiazide diuretic. P 5mg once daily, may be increased to Atenolol 50mg, chlorthalidone 12.5mg. White max. dose of 10mg daily depending on response. rifampicin), moderate P-gp inhibitors. Avoid grapefruit juice. A Diarrhoea.
60
film-ctd tab. marked TENORET 50 one side. 28, A4.61.
S Hypertension, particularly in the elderly. P 1 daily. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes.
TENORETIC
AstraZeneca
5MO Cardioselective b -blocker/thiazide diuretic. Atenolol 100mg, chlorthalidone 25mg. White filmctd tab. marked TENORETIC. 28, A6.53. S Mild to moderate hypertension. 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, A3.28; 50mg-28, A4.24; 100mg-28, A5.39. 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.
TEVETEN
Solvay
2MO Angiotensin II antagonist. Eprosartan mesylate 400mg pink oval film-ctd tab.; 600mg white cap.shaped film-ctd tab. 400mg-56, A24.02; 600mg-28, A18.01. S Essential hypertension. P Usual maintenance dose 600mg once daily. Q Not recommended. D Severe hepatic impairment. Pregnancy, lactation. B Severe renal impairment, patients undergoing dialysis, moderate hepatic impairment, severe cardiac insufficiency or renal artery stenosis. Correct vol/salt depletion prior to therapy. Primary hyperaldosteronism (avoid). Aortic and mitral valve stenosis, hypertrophic cardiomyopathy. Contain lactose. C Caution: K+sparing diuretics, K+suppl, lithium. A Viral infection, hypertriglyceridaemia, headache, dizziness, fatigue, depression, pain (incl. chest / back), palpitation, rhinitis, pharyngitis, dyspnoea, upper RTIs, cough, arthralgia, UTIs, GI disorders, asthenia, injury.
TEVETEN PLUS
Solvay
5MO Angiotensin II antagonist/thiazide diuretic. Eprosartan (as mesylate) 600mg and HCTZ 12.5mg. Butterscotch, capsule-shaped film-ctd tab. marked 5147 on one side and SOLVAY on reverse. 28, A18.68. S Essential hypertension for patients whose BP is not adequately controlled on eprosartan alone. P 1 once daily in the morning. Q Under 18 years, not recommended. D Severe hepatic impairment. Severe renal impairment, therapy resistant hypokalaemia or hypercalcaemia, biliary obstructive disorders, symptomatic hyperuricaemia/gout. Pregnancy,
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 lactation. B Renal artery stenosis, severe cardiac insufficiency, aortic and mitral valve stenosis or obstructive hypertrophic cardiomyopathy, mild to moderate hepatic insufficiency; caution. Monitor serum electrolytes periodically. Impaired renal function, diabetes mellitus; risk of increased serum K+. Primary hyperaldosteronism; not recommended. May exacerbate systemic lupus erythematosus. C Caution: K+-sparing diuretics, K+ suppl. or other drugs increasing K+ level (eg. heparin), drugs affected by serum K+ disturbances (eg. 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.
HYPERTENSION 2.4 3NO ALSO TRANDATE INJECTION Labetalol (HCl) 5mg/ ml. Amp. 5 x 20ml, A16.41. S Severe hypertension incl. severe hypertension of pregnancy; as a hypertensive agent in anaesthesia following acute myocardilal infarction. B See 2.4, b-blockers Drug Presc. Notes. Liver damage. Contains sodium benzoate.
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 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. 2MO C See 2.4, b-blockers Drug Presc. Notes. Class III Ca++ antagonist. Diltiazem (HCl) 200mg A Precipitation of atrioventricular block, pink/grey cap.; 300mg white/yellow cap.; purpura, thrombocytopenia, impotence. See 2.4, bcontaining immediate release and sust.-release blockers Drug Presc. Notes. pellets. 200mg-28, A11.87; 300mg-28, A12.95. S Hypertension. TRIALIX sanofi-aventis 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. ALSO TILDIEM RETARD Diltiazem (HCl) 90mg, P 1 daily taken in the morning. 120mg. Off-white sust.-release tabs. 90mg-56, Q Not recommended. A13.66; 120mg-56, A15.19. D History of angioneurotic oedema, aortic P 90-120mg twice daily. Max. 360mg stenosis, outflow obstruction. Precomatose states daily. associated with cirrhosis. Pregnancy, lactation. 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 diuretics, K+suppl., lithium, antidiabetic agents, C b -blockers, digitalis. A Bradycardia, 1st degree AV block, ankle NSAIDs, digitalis, aminoglycosides, cephalosporins. A Electrolyte imbalance. Nausea, vomiting, oedema, nausea, headache, rash. dizziness, fatigue, headache, abdominal pain, TRANDATE UCB diarrhoea, cough. Liver dysfunction. Rarely, symptomatic hypotension, angioneurotic oedema, 3MO 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; TRIAPIN sanofi-aventis A24.16; 200mg-50, A8.18; 56, A9.16; 250, A38.27. 2NO S Hypertension, incl. hypertension of Ca++ antagonist/ACE inhibitor. Felodipine/ramipril pregnancy and for long term management of 2.5mg/2.5mg, 5mg/5mg. Both circular, biconvex, hypertension following acute myocardial prolonged release tabs. marked with strength. infarction. Angina. 2.5mg, apricot coloured, marked H above OD on P Initially 100mg twice daily with food reverse; 5mg, reddish-brown, marked H above OE increasing if necessary at fouteen day intervals. on reverse. 2.5mg-28, A22.23; 5mg-28, A28.23. Max. 2.4g daily in three or four divided doses. Q Not recommended. S Essential hypertension when BP not
adequately controlled on felodipine or ramipril alone. P 1 tablet 2.5mg/2.5mg or 5mg/5mg once daily without food or following light meal. Max. 5mg/5mg once daily. Swallow whole, do not divide, crush or chew. Q Not recommended. D History of angioneurotic oedema, unstable haemodynamic conditions (cardiovascular shock, untreated HF, acute MI, unstable angina pectoris, stroke), AV block II or III. Severely impaired hepatic or renal renal function (ccQ20ml/ min), dialysis. Pregnancy, lactation. 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, A4.31; 2.5mg-28, A6.10; 5mg-28, A8.50; 10mg-28, A11.57. 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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
61
2.4 HYPERTENSION
CIRCULATORY SYSTEM
with 2.5, 5, 10 and 20 resp. All white with breakline on other side. 2.5mg-28, A5.38; 5mg-28, 10mg-28, A9.37; 20mg-28, A10.75. 120mg at weekly intervals according to response. S Arterial hypertension. 2MO P Initially 5mg in the morning; titrate to ACE inhibitor. Cilazapril 0.5mg, 1mg, 2.5mg, 5mg. Q Not recommended. D Cardiovascular shock, recent cardiac optimum BP control. Time interval between dose White, yellow, red or brown oval film-ctd scored infarction with complications, grade II and III AV increase q3 weeks. Maintenance, 10-20mg once tabs. marked CIL and strength. 0.5mg-28, A5.02; block, sinu-atrial blockage, sick sinus syndrome. daily. Max 40mg once daily. Renal dysfunction, 1mg-28, A8.11; 2.5mg-28, A13.06; 5mg-28, B Monitor BP at regular intervals patients who do not tolerate discontinuation of A18.79. diuretic treatment, volume/salt depleted, severe or S All grades of essential hypertension and particularly in 1st degree AV block, hypotension, bradycardia, atrial fibrillation/flutter or renovascular hypertension, initiate with 2.5mg in renovascular hypertension where standard therapy simultaneous pre-excitation syndrome. Impaired the morning. is ineffective or inappropriate. hepatic function. Pregnancy, lactation. R Initiate with 2.5mg in the morning. P Hypertension: initially 1mg once daily. C Anti-arrhythmic drugs, b-blockers, Q Not recommended. Maintenance usually 1-2.5mg once daily. inhalation anaesthetics, quinidine, digoxin, D Pregnancy, lactation. Renal artery Discontinue any diuretic 2-3 days before initiating lithium, carbamazepine, cimetidine, ranitidine, stenosis, post kidney transplant. History of therapy with 0.5mg once daily. Renovascular grapefruit juice. angioneurotic oedema. Aortic or mitral valve hypertension: initially 0.25-0.5mg once daily. A Constipation, dizziness, giddiness, stenosis, hypertrophic cardio-myopathy. Systolic BP Titrate according to response. R Hypertension: initially 0.5mg once daily. nervousness, headaches, fatigue, flush, paresthesia. Q100mmHg before treatment initiation. Permanent haemodialysis. Primary Renovascular hypertension: initially 0.25mg once VERISOP Gerard hyperaldosteronism. daily. B Diuretics (q80mg frusemide), 2MO Q Not recommended. hypovolaemia, hyponatraemia, hyperkalaemia. D Ascites, aortic stenosis, hypertrophic Class I Ca++ antagonist. Verapamil chlor. 40mg, Hypotension (first dose). Acute MI and cardiac cardiomyopathy or outflow obstruction. 80g, 120mg. White tabs. marked VL and strength failure (if unstable), renal impairment, high-dose Pregnancy, lactation. one side, G on reverse. 40mg-100, A3.53; 80mgvasodilator therapy. LDL-cholesterol apheresis. B Haemodialysis. Renal or hepatic 100, A5.16; 120mg-100, A10.59. Elderly. impairment, CHF, salt or volume depletion, S Mild to moderate hypertension. C Diuretics incl. K+sparing, K+suppl., other surgery, anaesthesia. P 40-120mg three times daily. antihypertensives, analgesics/anti-inflammatories, C K+sparing diuretics, NSAIDs. Q Not recommended. lithium, alcohol, anaesthetics, narcotics, hypnotics. A Headache, dizziness, fatigue, dyspepsia, D Cardiogenic shock. 2nd or 3rd degree Sympathomimetics, oral antidiabetic agents, AV block. Severe bradycardia. Uncompensated nausea, rash, coughing. Rarely angioneurotic insulin. cardiac failure. Sick sinus syndrome. oedema and alterations in blood count. A Hypotension, dizziness, fatigue, B 1st degree AV block. Poor cardiac arrhythmias. Proteinuria, dry cough, nausea VERAMIL Orion reserve should be controlled with digitalis and diuretics. Hepatic impairment. Acute phase of MI. (occasionally), abdominal pain, rash, headache. 2MO Bradycardia. Class I Ca++ antagonist. Verapamil chlor. 40mg, ZESGER PLUS Gerard C b-blockers, quinidine or digoxin. 80mg, 120mg. White film-ctd tabs. coded VL-40, A Constipation, headache, flushes. 5MO A VL-80 and VL-120. 40mg-100, 5.17; 80mg-100, A8.67; 120mg-100, A11.56. ACE inhibitor/diuretic. Lisinopril (as dihydrate) 20mg and HCTZ 12.5mg. Pink, round tab. marked S Essential hypertension. LHZ on one side and 32.5 on reverse. 28, A10.75. P 40-120mg three to four times daily. S Essential hypertension where BP not Severe liver dysfunction: Use 1/3 dose. ZANIDIP Recordati adequately controlled on lisinopril or HCTZ alone. D Severe left ventricular dysfunction. P Once daily depending on clinical Severe hypotension, cardiogenic shock. 2nd or 3rd 2 M O evaluation at about the same time each day. Max. degree AV block. Marked bradycardia. Sick sinus Class II Ca++ antagonist. Lercanidipine HCl 10mg, syndrome. CHF incl. including uncompensated HF. 20mg. Yellow, pink resp. scored film-ctd tab. 40mg lisinopril/ 25mg HCTZ. A A Lactation. Q Under 18 years, not recommended. 10mg-28, 10.93; 20mg-28, 17.85. B 1st degree AV block reported. D Renal artery stenosis. Angioneurotic S Mild to moderate essential Hypertrophic cardiomyopathy, elderly, attenuated hypertension. oedema. Severe renal/hepatic impairment. neuromuscular transmission. Mild to moderate HF P 10mg once a day at least 15 mins. Pregnancy, lactation. (control with digitalis and diuretics). Porphyria B Symptomatic hypotension may occur, before meals; may be increased to 20mg. (unsafe). Hepatic impairment (monitor during especially in patients with volume/salt depletion. Q Not recommended. long-term therapy). Contains lactose. Pregnancy. D Severe renal/hepatic dysfunction. LV Recent renal transplantation, dialysis; avoid. C Grapefruit juice, digitalis intoxication, IV outflow tract obstruction. Untreated congestive Anaphylactoid reactions. Risk of hyperkalaemia, b-blockers (contra). Colchicine, cisapride (avoid). a/ cardiac failure. Unstable angina pectoris. Within 1 renal impairment, diabetes mellitus, major surgery, month of a MI. Pregnancy (women of childb-blockers, CYP3A4 inhibitors/substrates, impaired liver function; caution. Withdraw if bearing potential should use adequate antiarrhythmics, CCBs, cardiac glycosides, neutropenia, angioedema or jaundice occurs. contraception), lactation. theophylline, imipramine, glyburide, doxorubicin, C Lithium (avoid). K+ suppls, K+-sparing B Sick sinus syndrome, LV dysfunction, paclitaxel, tamoxifen, cimetidine, statins, diuretics or K+-containing salts, trimethoprim, ischaemic heart disease. Elderly. Mild/moderate almotriptan, halothane, dantrolene, Ca++ salts, diuretics. Caution: Lisinopril: NSAIDs, other renal or hepatic dysfunction. Contains lactose. alcohol, lithium, timolol eye drop, quinidine, antihypertensive agents, TCAs, sympatomimetics, C Contra: CYP3A4 inhibitors (e.g. antihypertensives. antidiabetics, allopurinol, ciclosporin, lovastatin, ketoconazole, ritonavir, erythromycin), A Constipation, headache, dizziness, immunosuppressive agents. HCTZ: Amphotericin B cyclosporine, grapefruit juice. Avoid: alcohol, fatigue, rash, bradycardia, hypotension, cardiac (parenteral), carbenoxolone, corticosteroids, CYP3A4 substrates (terfenadine, astemizole, class insufficiency, swelling of ankles. corticotropine, stimulating laxants, Ca++ salts, III antiarrhythmics). Caution: CYP3A4 inducers cardiac glycosides, colestyramine resin, colestipol, VERAP Rowex (anticonvulsants, phenytoin, carbamazepine), non-depolarizing muscle relaxants, drugs midazolam, digoxin, b-blockers, cimetidine. associated with torsades de pointes, sotalol. 2MO A Dizziness, headache, fatigue, dry and Class I Ca++ antagonist. Verapamil (HCl) 120mg, ZESGER Gerard persistent cough, hypotension incl. orthostatic 240mg. Beige scored and green oblong scored hypotension. 2MO both sides; both film-ctd prolonged release tabs. 120mg-30, A5.43; 240mg-30, A10.85. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. ZESTAN Clonmel Round, flat beveled edge, square biconvex and S Mild to moderate hypertension. 2MO pentagonal biconvex tabs. debossed on one side P 240mg in the morning increasing if angioneurotic oedema, syncope.
VASCACE
62
necessary to 240mg twice daily with a 12 hour interval.
Roche R 120mg in the morning, increasing by
A7.59;
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 ACE inhibitor. Lisinopril 2.5mg, 5mg white tabs. marked with strength and scored both sides; 10mg, 20mg white tabs. marked with strength and quadrisected both sides. 2.5mg-28, A4.84; 5mg-28, A6.95; 10mg-28, A8.35; 20mg-28, A9.76. S Arterial hypertension. P Initially 5-10mg once daily in the morning, increasing in intervals of at least 3 weeks up to 20mg daily maintenance dose. Max. 80mg once daily. A lower initial dose 2.5mg in patients with renal impairment, HF, volume and/or salt depletion, severe or renovascular hypertension, patients who do not tolerate discontinuation of diuretic therapy, elderly. Q Not recommended. D Angioneurotic oedema, severe renal 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.
PERIPHERAL initiate with 2.5-5mg daily. Discontinue diuretic 23 days before initiating with 5mg daily or reduce diuretic dose. 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.
VASCULAR DISORDERS
2.5
disease, peripheral arteriosclerosis, acrocyanosis, chilblains. P 2 three times daily. Q Not recommended.
2 ALSO HEXOPAL FORTE Inositol nicotinate 750mg. White oval scored tab. marked HEX 750. 112 (Cal/ Pk), A35.27; 250, A95.87. P 2 twice daily. Q Not recommended. B Pregnancy.
HYPOVASE
Pfizer
2MO
Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. White tab. marked Pfizer and white tab. scored 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; 2MO maintenance 1-2mg twice daily. Cardioprotective ACE inhibitor. Zofenopril 30mg. Q Not recommended. A White oval film-ctd tab. 30mg-28, 14.02. D Sensitivity other quinazolines. S Hypertension. B Pregnancy, lactation. Initial low dose P Usually 30mg once daily; max. 60mg. and gradual titration is recommended, monitor Q Not recommended. BP. D Angioneurotic oedema, severe hepatic C Other antihypertensives. Caution: PDE-5 impairment, renal artery stenosis. Pregnancy, inhibitors. lactation. Women of child-bearing potenial unless protected by effective contraception. MIDON Shire B Reduce dosage of diuretic if possible 0MO 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, C Other anti-hypertensive agents, A117.16. diuretics, lithium, K+sparing diuretics, K+suppl., S Idiopathic orthostatic hypotension. NSAIDs. P Initially 2.5mg two to four times daily, ZESTORETIC 20 AstraZeneca A Dizziness, fatigue, headache, cough, gradually increasing by 2.5mg at weekly intervals 5NO nausea, vomiting, rash, muscle cramp, weakness. until optimal response. Last dose should be taken ACE inhibitor/thiazide diuretic. Lisinopril 20mg, at least 4 hours before bedtime. Max. 30mg daily. HCTZ 12.5mg. White tab. marked ZESTORETIC 20. 2.5 PERIPHERAL VASCULAR DISORDERS Q Not recommended. 28 (Cal/Pk), A10.76. ADALAT Bayer Schering D Hypertension, severe organic heart 5NO disease, hyperthyroidism, thyrotoxicosis, 2MO ALSO ZESTORETIC 10 Lisinopril 10mg, HCTZ phaeochromocytoma, acute nephritis or urinary ++ A 12.5mg. Peach tab. 28 (Cal/Pk), 9.38. Class II Ca antagonist. Nifedipine 5mg, 10mg. retention, vasovagal hypotension, narrow angle Orange, gelatin ovoid caps. containing yellow S Management of hypertension in glaucoma. Pregnancy, lactation. fluid. 5mg-90, A6.32; 10mg-90, A8.02. patients stabilised on the individual components B Renal insufficiency. Driving/using S Raynaud’s phenomenon. or where no response to monotherapy with machines. Contains sunset yellow. P Initially 5mg eight hourly adjusted lisinopril. C Sympathomimetic agents, guanethidine, according to response, increasing to max. 20mg P 1 once daily. reserpine, atropine, antihistamine, thyroid every 8 hrs. Q Not recommended. hormones, methyldopa, tricyclic antidepressants. Q Not recommended. D Pregnancy. Anuria, aortic stenosis, MAOIs. Digitalis or other glycosides, D Women of child-bearing potential, hyperkalaemia, history of angioneurotic oedema. mineralcorticoids or glucocorticoids. lactation. Cardiogenic shock, aortic stenosis. Acute A Nausea, vomiting, dyspepsia, chills, B First dose hypotension in fluid or angina attacks, unstable angina pectoris, MI electrolyte depletion, renal impairment, hepatic headache, dizziness, rash, urinary retention. 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, indomethacin, antidiabetics, corticosteroids. impairment, severe hypotension. Diabetes, dialysis. pruritus, flushing, dysuria. A Dizziness, headache, cough, Elderly. Driving/using machines. Palpitations, NIFED Rowex hypotension, syncopes, fatigues, rash, GI disorders, hypotension, tachycardia reported. impotence, muscle cramps, paraesthesia. C Contra: Rifampicin. Avoid grapefruit 2MO 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, 2MO S Raynaud’s phenomenon. ACE inhibitor. Lisinopril 2.5mg, 5mg, 10mg, 20mg. CYP3A4 inhibitors. P 30-60mg daily in divided doses. A Headache, vasodilatation, nausea, White, pink, pink, red tabs. resp. marked with R 15mg in divided doses. dizziness, peripheral oedema. heart shape, strength and ZESTRIL. 2.5mg-28, Q Not recommended. A5.39; 5mg-28, A7.60; 10mg-28, A9.38. 20mg-28, D Cardiogenic shock. unstable angina HEXOPAL Clonmel A10.76. pectoris, advanced aortic stenosis, porphyria, acute 2 O 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 cardiac reserve, diabetes, malignant hypertension, 10-20mg once daily. Renovascular hypertension: S Intermittent claudication, Raynaud’s AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
63
2.6 PROPHYLAXIS
OF
MI,
STROKE AND VASCULAR DEATH
treatment not started on day of surgery, starting dose is 220mg once daily. Moderate renal impairment: Initially 75mg within 1-4 hours of surgery, then 150mg once daily. Concomitant use with amiodarone: reduce dose to 150mg. R Over 75 years, initially 75mg within 1-4 hrs of surgery, then 150mg once daily for 10 days (knee) or 28-35 days (hip). Q Under 18 years, not recommended. D Severe renal impairment. Active NIMOTOP Bayer Schering bleeding, organic lesion at risk of bleeding, impairment of haemostasis. Hepatic impairment or 2MO Class II Ca++ antagonist. Nimodipine 30mg. Yellow liver disease expected to have impact on survival. film-ctd tab. marked with Bayer cross on one side Pregnancy (unless necessary), lactation. B Not recommended: Elevated liver and SK on reverse. 100, A42.25. enzymes (q2xULN), anaesthesia with postS Prevention of ischaemic neurological operative indwelling epidural catheters (wait 2 hrs deficits following aneurysmal subarachnoid min. after catheter removal; monitor neurological haemorrhage. signs and symptoms), hip fracture surgery (no P 2 tabs. four hourly starting within 4 days of subarachnoid haemorrhage and continued data). Monitor for bleeding or anaemia during for 21 days. If cerebral ischaemia occurs, continue treatment, especially in at-risk patients. Caution: Moderate renal impairment, high surgical tab. to complete 21 days or substitute by soln. mortality risk, thromboembolic risk. Contains Q Not recommended. sunset yellow. 2N C Contra: Quinidine. Not recommended: ALSO NIMOTOP SOLUTION Nimodipine 0.2mg/ml. Heparins, fondaparinux, desirudin, thrombolytic Soln. for inf. in vial. 5 x 50ml vial (with 5 inf. agents, GPIIb/IIIa receptor antagonists, clopidogrel, lines), A74.47. ticlopidine, dextran, sulfinpyrazone, vit. K S Treatment of ischaemic neurological antagonists. Caution: Amiodarone, strong Pdeficits following aneurysmal subarachnoid glycoprotein inhibitors (e.g. verapamil, haemorrhage. clarithromycin), potent P-glycoprotein inducers P 1mg per hour by IV inf. for first 2 hrs, (e.g. rifampicin, St Johnâ&#x20AC;&#x2122;s wort). then 2mg per hr for min. 5 days, max. 14 days. If A Bleeding events, anaemia, haematoma, surgical intervention during treatment, admin. haematuria, decreased Hb, wound secretion. should be continued for at least 5 days. If tabs. and inf. are admin. sequentially, total duration of PRAXILENE Merck Serono treatment should not exceed 21 days. Patients 2MO under 70kg or with unstable BP, start on 0.5mg Peripheral and cerebral activator. Naftidrofuryl per hr or less if necessary. oxalate 100mg. Pink cap. marked PRAXILENE. 100, Q Not recommended. A11.87. D Unstable angina episode, MI (within 1 S Cerebral and peripheral vascular month). disorders. B Cerebral oedema, raised IOP. P 1-2 three times daily. Hypotensive patients. Pregnancy. Monitor BP in cirrhotic patients. Renal impairment (inf.) Transient Q Not recommended. D History of hyperoxaluria or recurrent rise in liver enzymes (inf.). Nimotop inf. is incompatible with PVC and contains ethanol, Na+. Ca++-containing stones. Pregnancy, lactation. A Nausea, epigastric pain, skin rash, C Oral nimodipine: Contraindicated with insomnia. Rarely; hepatitis, kidney stones. antiepileptics, phenobarbital, phenytoin, carbamazepine, rifampicin. Caution: Quinupristin/ sanofi-aventis dalfopristin. Nimodipine inf: Caution, nortriptyline, TRENTAL 2MO nephrotoxic drugs. Both: Grapefruit juice, not recommended. Caution: Diuretics, b-blockers, ACE Xanthine. Pentoxifylline 400mg. Pink oblong inhibitors, A1 antagonists, methyldopa, other Ca++ modified-release ctd tab. 100, A20.64. antagonists, a-adrenergic blocking agents, PDE5 S Peripheral vascular disease and inhibitors, fluoxetine, cimetidine, Na+ valproate, cerebrovascular insufficiency. zidovudine, CYP3A4 inducers and inhibitors. Do P 400mg, 2 or 3 times daily. not use tab. and inf. concomitantly. Q Not recommended. D Acute MI or cerebrovascular accident. PRADAXA Boehringer Ing. Massive bleeding or extensive retinal bleeding. B Monitor patients with hypotension, 2NO Direct thrombin inhibitor. Dabigatran etexilate (as severe coronary artery disease, severe cardiac arrhythmias, renal impairment or increased mesilate), 75mg, 110mg. Light blue and cream bleeding tendency. May potentiate effects of capsules filled with yellowish pellets, imprinted insulin or oral antidiabetic agents. Pregnancy, with company symbol and R75 and R110 resp. lactation. 75mg-10, A23.95, 75mg-60, A143.70, 110mgC Hypoglycaemics, antihypertensives, A A 10, 23.95, 110mg-60, 143.70. theophyilline, anticoagulants, antiplatelets, S Primary prevention of venous ketorolac. thromboembolic events in adults after elective A GI disorders, flushing, headache, total hip replacement surgery or total knee dizziness, agitation, sleep disorders, cardiac replacement surgery. arrhythmias , hypersensitivity reactions including P Initially, 110mg within 1-4 hours of surgery, then 220mg once daily for 10 days (knee) anaphylactic / anaphylactoid reactions. or 28-35 days (hip). If haemostasis not secured, XARELTO Bayer Schering initiation of treatment should be delayed. If irreversible renal failure with hypovolaemia, risk of hypotensive crisis (medical supervision). 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.
64
CIRCULATORY SYSTEM 2NO Antithrombotic agent. Rivaroxaban 10mg. Light red, round film-ctd tab. marked with Bayer-cross one side and 10 and a triangle on the other. 30; 100. Prices on request. S Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. P 10mg once daily. Initially, 6-10 hours after surgery, if haemostasis established. Hip surgery: Continue for 5 weeks. Knee surgery: 2 weeks. Q Not recommended. D Clinically significant active bleeding. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk. Pregnancy, lactation. 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 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 Prinzmetalâ&#x20AC;&#x2122;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 ++
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 Stroke within 30 days, intracranial disease, GI bleeding within 30 days, malignant hypertension, surgery or trauma past 6 weeks, thrombocytopenia (platelet count Q100,000/mm3), clotting disturbances, severe liver failure. Pregnancy, lactation. B Cardiopulmonary resuscitation, organ biopsy or ithotripsy within last 2 weeks, active peptic ulcer within 3 months, uncontrolled hypertension, acute pericarditis, vasculitis, aortic dissection, haemorrhagic retinopathy, haematuria, occult blood in stools. Recent relevant bleeding within 1 year, severe acute or chronic HF, cardiogenic shock, mild to moderate liver insufficiency, platelet function disturbances, thrombocytopenia (platelet count Q150,000/mm3), anaemia, female, elderly or low body weight 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 Antithrombotic. Bivalirudin 250mg. White device), A612.01. lyophilised powder for concentrate for soln for inj. S MI, pulmonary embolism, ischaemic or inf. 10 vials, A5,292.94. stroke. S Anticoagulant in patients undergoing P MI/PE: Total dose 100mg IV. MI - over 90 mins. if within 6 hours of symptom onset, over percutaneous coronary intervention (PCI). P Intravenous bolus of 0.75mg/kg 3 hours if 6-12 hours. PE - over 2 hours. See SPC. followed by inf. of 1.75 mg/kg/hr for duration of Ischaemic stroke: Total dose 90mg as IV inf. over procedure for up to 4 hours post-PCI. Arterial 60 mins. with 10% dose admin. as initial IV bolus sheath can be removed 2 hours after inf. Renal within 3 hours of onset. See SPC. insufficiency: Monitor ACT, see SPC. Moderate Q Not recommended. renal insufficiency: Reduce Inf. rate to 1.4mg/kg/ D Current or recent haemorrhage, 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.
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, 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.
2.6
D Active gastric or duodenal ulcers, bleeding disorders. Pregnancy (especially last trim), lactation. B Severe coronary artery disease, coagulation disorders, asthma, allergic rhinitis, nasal polyps, chronic or recurring gastric or duodenal complaints, impaired renal or hepatic function or G6PD deficiency, hypersensitivity to NSAIDs. Contains lactose. C Adenosine, antihypertensives, anticoagulants, other antiplatelets, valproic acid, SSRIs, other NSAIDs, corticosteroids, chronic alcohol use, hypoglycaemics, methotrexate, spironolactone, uricosuric agents. A Dizziness, vomiting, diarrhoea, nausea, dyspepsia, epigastric distress, headache, myalgia, hypotension, hot flushes, tachycardia, 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 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.
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. specialist supervision. S Secondary prevention of ischaemic orthopaedic surgery), 40mg SC inj. 12 hrs pre-op, P Initially 0.4mcg/kg per min. of the stroke and transient ischaemic attacks. then 40mg once daily for 7-10 days. Medical diluted soln. by IV infusion for 30 mins. starting P One cap. swallowed whole twice daily. patients: 40mg once daily SC inj. for 6-14 days. within 12 hours of the last angina episode. Then Intorable headache, only 1 daily at bedtime and Treatment of DVT or PE: 1.5mg/kg daily SC inj or 0.1mcg/kg per min. by IV infusion for at least 48 low dose ASA in morning; return to usual regimen 1mg/kg twice daily SC inj. for complicated VTE. All hours. Max. treatment period 108 hours. asap, usually within 1 week. for r 5 days and until adequate oral Q Not recommended. Q Under 16 years, not recommended. anticoagulation established. Haemodialysis: R 4 AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
65
2.6 PROPHYLAXIS
OF
MI,
hrs: 1mg/kg bolus dose into arterial line prior to session. q4 hrs or if fibrin rings found: further dose of 0.5-1mg/kg. Treatment of UA and NQWMI: 1mg/kg 12 hourly SC inj. with oral aspirin (100325mg once daily) for 2-8 days and until clinical stabilisation. Treatment of acute STEMI: 30mg single IV bolus plus 1mg/kg SC inj. followed by 1mg/kg SC inj. every 12 hrs for 8 days or until hosp. discharge. (max 100mg for the first 2 doses only, followed by 1mg/kg for remaining doses). Elderly (r75 years): do not use initial IV bolus. 0.75mg/kg SC every 12 hrs (max. 75mg for first 2 doses only, followed by 0.75mg/kg for remaining doses). PCI: If the last SC admin was Q 8 hrs before balloon inflation, no additional dosing needed. q 8 hrs give 0.3mg/kg IV bolus. Q Not recommended. 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.
2MO Antiplatelet. Clopidogrel (HCl) 75mg. Pink, round, slightly convex film-ctd tab. 28, A 34.79. S Prevention of atherothrombotic events in 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. Q Children and adolescents, not recommended. D Severe liver impairment. Active pathological bleeding such as peptic ulcer or intracranial haemorrhage. Pregnancy, lactation (precautionary measure). B Caution: Patients at risk of increased bleeding from trauma, surgery or other 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 pathological bleeding such as peptic ulcer or 2MO intracranial haemorrhage. Pregnancy, lactation Antiplatelet. Clopidogrel (as HCl) 75mg. Pink, film- (precautionary measure). ctd, round shaped tab. 28, A36.43. B Not recommended: Acute ischaemic S Prevention of atherothrombotic events stroke (within 7 days). Caution: Patients at risk of in adults suffering from MI (from a few days until increased bleeding from trauma, surgery or other Q 35 days), ischaemic stroke (from 7 days until Q pathological conditions or treatment, incl. lesions 6 months) or established peripheral arterial with propensity to bleed (GI and intraocular); disease. renal impairment, patients with moderate hepatic P 75mg daily as single dose. disease who may have bleeding diatheses. D Severe liver impairment. Active Discontinue 7 days prior to surgery. Consider pathological bleeding (peptic ulcer or intracranial blood cell count determination and/or other haemorrhage). Pregnancy, lactation (no data). appropriate testing if clinical symptoms suggestive B Not recommended: Acute ischaemic of bleeding arise during treatment. Thrombotic stroke (within 7 days). Caution: Renal impairment, Thrombocytopenic Purpura (TTP) reported very moderate hepatic impairment in patients with rarely. Contains hydrogenated castor oil. bleeding diatheses. Risk of bleeding (caution: Trauma, GI or intraocular lesions with a propensity C Not recommended: Anticoagulants. Caution: ASA, heparin, thrombolytics, glycoprotein to bleed, surgery); discontinue 7 days prior to IIb/IIIa inhibitors, NSAIDs. elective surgery; warn patients to report unusual A Haematoma, epistaxis, GI disorders, bleeding. Thrombotic Thrombocytopenic Purpura 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
66
CIRCULATORY SYSTEM
STROKE AND VASCULAR DEATH
reverse. 5mg-30, A14.12; 10mg-30, A22.59. S Stable coronary artery disease reduction of risk of cardiac events in patients with history of MI and/or revascularisation. P 10mg once daily. Initially, 5mg once daily for 4 weeks, if tolerated increase to 10mg once daily. 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.
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.
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
intervention (PCI) is performed during therapy, continue inf. for 20-24 hours post-PCI for a total max. duration of 96 hours. Anticoagulant. Tinzaparin 20,000 anti-Factor Xa IU Q Under 18 years, not recommended. per ml. Syringes x 10: 10,000 IU-0.5ml, A77.47; D GI, genitourinary or other abnormal 14,000 IU-0.7ml, A108.13; 18,000 IU-0.9ml, bleeding within previous 30 days. Stroke within 30 A139.44. Vial x 1: 20,000/ml-2ml, A28.86. days or history of haemorrhagic stroke. S Venous thrombosis and thromboembolic Intracranial disease. Major surgery or severe disease incl. deep vein thrombosis and pulmonary trauma within past 6 weeks. Thrombocytopenia, embolism. prothrombin time q1.2 times control or INR q2. P 175 IU/kg body weight once daily by SC Severe hypertension. Severe renal or hepatic inj. for at least 6 days and until adequate oral impairment. Hiistory of bleeding diathesis. anticoagulation is achieved. Routine monitoring of Lactation. anticoagulant effect not necessary. B Monitor patients for bleeding. Stop Q Not recommended. immediately if thrombolytic therapy or emergency 2NO cardiac surgery required or if serious bleeding occurs. Hepatic impairment. Increased risk of ALSO INNOHEP 10,000 IU/ML Tinzaparin 10,000 bleeding with thrombolytics, oral anticoagulants, anti-Factor Xa IU per ml. Fixed dose syringes and dextran solns., adenosine, LMWH, vials. 2500 IU, A25.12; 3500 IU, A35.16; 4500 IU, A45.20 (syringes x10); 10,000/ml-2ml (vials x 10), sulphinpyrazone, prostacyclin, NSAIDs, A144.34. dypyridamole, ticlopidine, clopidogrel. Pregnancy. C Other parenteral GPIIb/IIIa inhibitors. S Prophylaxis of deep vein thrombosis. A Bleeding or cardiac events. Prevention of clotting in in-dwelling intravenous lines for extracorporeal circulation during LESCOL XL Novartis haemodialysis. P Prophylaxis of DVT: Admin. by SC route 2 M O only. Low to moderate risk DVT, e.g. all general + Statin. Fluvastatin (as Na ) 80mg. Yellow surgery, 3500 IU starting 2 hrs before surgery. prolonged release tab. marked LE one side, NVR Admin. dose once daily for 7-10 days post-op. or on reverse. 28 (Cal/Pk), A22.72. for the required period of cover. High risk of DVT, 2 M O e.g. orthopaedic surgery, either 4,500 IU starting ALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. 12 hrs pre-op. and followed by once daily dose or Brown/yellow caps. marked with XU, strength and alternatively 50 IU/kg 2 hrs before surgery company logo. 20mg-28 (Cal/Pk), A14.55; 40mg-28 followed by once daily dose. Haemodialysis: Short(Cal/Pk). A17.16; 40mg-56 (Cal/Pk), A32.15. term haemodialysis (Q4 hrs) bolus dose of 2000S Secondary prevention of major adverse 2500 IU into arterial side of dialyser (or IV) at cardiac events (coronary revascularization, cardiac beginning of dialysis. Long term haemodialysis death and non-fatal MI) in patients with CHD (q4 hrs) bolus dose of 2500 IU into arterial side of after coronary transcatheter therapy. dialyser (or IV) at beginning of dialysis followed P 80mg daily. by inf. of 750 IU/hr. Q Under 18 years, not recommended. Q Not recommended. D Active liver disease or persistent D Haemorrhagic tendency, incl.: unexplained elevation of transaminase levels, Uncontrolled severe hypertension, severe liver cholestasis. Myopathic disorders. Caution if history failure, septic endocarditis, intracranial of liver disease, high alcohol consumption. haemorrhage, injuries/operations on CNS, eyes or Pregnancy, lactation. ears, active peptic ulcer, threatened abortion, B Monitor serum transaminase levels heparin induced thrombocytopenia. Spinal/ epidural anaesthesia (full dose).Vials in premature before and periodically during treatment. Severe renal impairment. Unexplained diffuse myalgias, babies and neonates. muscle tenderness, muscle weakness and/or B Do not admin. by IM inj. Severe renal marked elevated creatine phosphokinase (CPK) failure, increased risk of bleeding complications. Regular platelet counts necessary. Increased risk of values due to myopathy, myositis or rhabdomyolysis; discontinue. hyperkalaemia. Sulphite sensitivity (20,000IU/ml). C Cholestyramine (admin. min. 4 hrs Pregnancy (avoid 2ml vial), lactation. before Lescol). Caution: Rifampicin, warfarin, C Caution: Drugs affecting platelet immunosuppressants (incl. cyclosporin), function, salicylates, NSAIDS, vitamin K gemfibrozil, nicotinic acid, erythromycin, antagonists, dextran. glibenclamide. A Bleeding events, reversible increase in A Dyspepsia, abdominal pain, nausea, liver enzymes, reversible thrombocytopenia, skin insomnia, headache. reactions.
INNOHEP
LEO Pharma
2NO
INTEGRILIN
GSK
LOCHOL
Clonmel
2N
2MO
Antiplatelet. Eptifibatide 2mg/ml soln. in vial for inj.; 0.75mg/ml soln. in vial for inf. Inj.-10ml, A20.77. Inf.-100ml, A65.21. S Prevention of early myocardial infarction in patients with unstable angina or nonQ-wave MI with the last episode of chest pain within 24 hours and with ECG changes and/or elevated cardiac enzymes. For use with aspirin and unfractionated heparin. P Initially 180mcg/kg by IV bolus inj., followed by continuous inf. of 2mcg/kg/min. for up to 72 hours. If percutaneous coronary
Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 hard cap. with blue or green cap and white body. 20mg-28, A7.56; 40mg-28, A8.92. S Secondary prevention of coronary events in patients with coronary heart disease after coronary transcatheter therapy. P 80mg daily. Q Under 18 years, not recommended. D Active liver disease, or unexplained, persistent elevations in serum transaminases. Pregnancy, lactation. B Monitor liver function before and
2.6
periodically during treatment; discontinue if increase in AST or ALT exceeds 3 x ULN and persists. Caution: History of liver disease, heavy alcohol consumption. Caution (measure CK levels before starting treatment): Renal impairment, hypothyroidism, personal or familial history of hereditary muscular disorders, previous history of muscular toxicity with a statin or fibrate, alcohol abuse, elderly (if other predisposing factors present). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur; stop treatment if CK levels q5 x ULN. If symptoms are severe and cause daily discomfort, consider discontinuation even if CK levels Q5 x ULN. Homozygous familial hypercholesterolemia: Not recommended. 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, GI disorders, arthralgia.
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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
67
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CIRCULATORY SYSTEM 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 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.
PROPHYLAXIS
OF
MI,
STROKE AND VASCULAR DEATH
2.6
previous ACE inhibitor therapy. Hereditary or idiopathic angioedema. Pregnancy, lactation. 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 cardiomyopathy, collagen vascular disease, 2MO immunosuppressant therapy, treatment with Salicylate. Aspirin 75mg. White ent-ctd tab. allopurinol or procainamide, diabetes. Renal marked with strength. 28, A1.90; 56, A3.81. impairment: Adjust dosage according to cc and S Prevention of secondary MI. response to treatment. Anaphylactoid reactions Antithrombotic in patients with unstable angina may occur during dialysis with high flux or ischaemic stroke. membrane or low-density lipoproteins apheresis P Acute: 2 tabs chewed. Maintenance: 1 with dextran sulphate. Discontinue if angioedema tab. daily. occurs. May occur: Hepatic syndrome, neutropenia/ Q Not recommended. agranulocytosis, thrombocytopenia, anaemia, D Hypoprothrombinaemia, haemophilia, persistent non-productive cough, elevation in cerebral haemorrhage, active peptic ulceration, serum K+. Discontinue 1 day prior to surgery. lactation. B Not for short-term relief of pain. Renal, C Avoid: Diuretics, K+ sparing diuretics, K+containing salt substitutes, K+ supplements, cardiac or hepatic impairment. May induce GI lithium. Caution: NSAIDs, other antihypertensives haemorrhage. Long-term use, elderly; review and vasodilators, antidiabetics, TCAs, regularly. Caution: History of IBD, coagulation antipsychotics, anaesthetics, sympathomimetics, abnormalities. Hypertension, monitor. Pregnancy antacids. (avoid at term). C Avoid: Warfarin, heparin, other NSAIDs, A Headache, dizziness, vertigo, paresthaesia, vision disturbance, tinnitus, antacids (simultaneous use). Caution: Antihypertensives, diuretics, cardiac glycosides, lithium, hypotension and related effects, cough, dyspnoea, GI disturbances, rash, pruritus, asthenia. methotrexate, ciclosporine, tacrolimus, corticosteroids, aminoglycosides, probenecid, oral PERSANTIN RETARD Boehringer Ing. hypoglycemics, anticoagulants, antiplatelets, fibrinolytics, carbonic anhydrase inhibitors, 2MO ibuprofen. Antiplatelet. Dipyridamole 200mg. Red/orange MICARDIS Boehringer Ing. A Asthma, urate kidney stones, chronic GI modified release hard gelatin cap. containing blood loss, tinnitus, nausea, vomiting. 2MO yellow pellets. 60, A12.80. Angiotensin II antagonist. Telmisartan 20mg, S Secondary prevention of ischaemic OMACOR Solvay 40mg, 80mg. White tabs. marked 50H, 51H, 52H stroke and transient ischaemic attacks either alone 2MO resp. on one side and company symbol on other. or in conjunction with aspirin. Adjunct to oral Polyunsaturated fatty acid. Omega-3-acid ethyl 20mg: Round. 40mg, 80mg: Oblong. 20mg-28, anti-coagulation for prophylaxis of A19.16; 40mg-28, A19.16; 80mg-28, A23.14. esters 1000 mg (including EPA and DHA 840 mg). thromboembolism associated with prosthetic heart S Reduction of cardiovascular morbidity in Soft, oblong, transparent gelatin caps. containing valves. A pale yellow oil. 28, 17.56. patients with manifest atherothrombotic P 1 twice daily with meals. Caps. should S Secondary prevention after MI, in cardiovascular disease (history of coronary heart be swallowed whole without chewing. addition to other standard therapy. disease, stroke, or peripheral arterial disease) or Q Not recommended. P 1 daily with food. type 2 diabetes mellitus with documented target D Acute hypotension, particularly after MI. Q Not recommended. organ damage. B Severe coronary artery disease (unstable D Pregnancy, lactation (no data). P 80mg once daily. Close monitoring of angina, recent MI, LV outflow obstruction, B Exogenous hypertriglyceridaemia (type 1 haemodynamic instability), myasthenia gravis, BP recommended. hyperchylomicronaemia); not indicated. Hepatic Q Not recommended. coagulation disorders. Pregnancy, lactation. impairment (monitor hepatic function, especially D Biliary obstructive disorders, severe C Adenosine, oral anticoagulants, with high dosage). Patients at high risk of hepatic impairment. Pregnancy, lactation. hypotensive agents, cholinesterase inhibitors. haemorrhage. Moderate increase in bleeding time A GI disturbances, dizziness, nausea, B Mild moderate hepatic impairment, may occur with high dosage (i.e. 4 cap.) renovascular hypertension, renal impairment, headache, myalgia, hypotension, hot flushes, C Oral anticoagulants (monitor and adjust tachycardia, hypersensitivity reactions (rash, kidney transplant, intravascular volume depletion (correct prior to admin.), RAA stimulation, primary dose). urticaria, bronchospasm). A GI disturbances. aldosteronism, aortic and mitral valve stenosis, PLAVIX sanofi-aventis/BMS obstructive cardiomyopathy. May cause PENDREX Rowex 2 M O hyperkalaemia (monitor serum K+ in at risk patients). Contains sorbitol. Apparently less 2MO Antiplatelet. Clopidogrel (hydrogen sulphate) effective in black patients than other racial 75mg, 300mg. Pink film-ctd tabs. 75mg round ACE inhibitor. Perindopril tert-butylamine 2mg, groups, ischaemic cardiopathy or CVD. marked 75 and 1171. 300mg oblong marked 300 4mg, 8mg. White, round, biconvex tablet C Not recommended: K+ sparing diuretics debossed with 2, 4 or 8 on one side. 2mg-30, and 1332. 75mg-28, A45.54 (GMS); 300mg-30, or K+ supplements, lithium. Caution: NSAIDs, A8.53; 4mg-30, A12.07; 8mg-30, A16.70. A202.48 (not GMS). diuretics, heparin, immunosuppressors, S Reduction of risk of cardiac events in S Prevention of atherothrombotic events trimethoprim. Concomitant use to be taken into patients with a history of MI and/or in patients suffering from MI (from a few days account: Other antihypertensives, baclofen, revascularisation. until less than 35 days), ischaemic stroke (from 7 amifostine alcohol, barbiturates, narcotics or P Initially 4mg once daily for 2 weeks, days until less than 6 months) or established antidepressants, systemic corticosteroids. increased to 8mg depending on renal function. peripheral arterial disease. In combination with Renal impairment: See SPC. aspirin in non-ST segment elevation acute MONOPARIN CP Pharm. R 2mg once daily week 1, 4mg once daily coronary syndrome (unstable angina or non-Q 2N week 2, increased to 8mg depending on renal wave MI) and ST segment elevation acute MI Anticoagulant. Heparin Na+ 25 000units/ml in WFI. function. (STEMI) in medically treated patients eligle for Preservative-free, single dose amps. 10 x 0.2ml (5 Q Not recommended. thrombolytic therapy. 000 IU), price on request. D History of angioedema associated with P 75mg daily. Non-ST segment elevation
MULTIPARIN
Pinewood
2N
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
69
2.6 PROPHYLAXIS
OF
MI,
cardiovascular death in patients with increased cardiovascular risk, already taking standard therapy and in type 2 diabetic patients with increased cardiovascular risk. 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 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, A12.07; 8mg-30, A19.27. 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, before and during treatment. Hyperkalemia, S Acute myocardial infarction. increases in blood urea and plasma creatinine. P Two x 10 unit bolus inj.s 30 mins. apart, Caution: Mitral valve stenosis, obstruction in the each by slow IV inj. over max. 2 mins. within 12 outflow of left ventricle, diabetes. LDL apheresis. hrs of MI. See SPC. Jaundice, angioedema (facial/ intestinal) reported Q Not recommended. rarely; discontinue promptly. Discontinue one day D Haemorrhagic diathesis, intracranial prior to surgery. Contains lactose. neoplasm, arteriovenous malformation or C Lithium, K+ supplements (not aneurysm, CVA, within 10 days of external heart 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 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 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.
70
CIRCULATORY SYSTEM
STROKE AND VASCULAR DEATH
Recombinant DNA anticoagulant. Lepirudin 50mg. Powder in vial for soln. 10 x 50mg. Price on request. S Heparin-induced thrombocytopenia (HIT) type II and thromboembolic diseases requiring antithrombotic therapy. P Initially 0.4mg/kg body weight followed by 0.15mg/kg body weight per hour as continuous IV inf. for 2-10 days. See SPC. Q Not recommended. D Pregnancy, lactation. Recent puncture of large vessels, organ biopsy, cardiovascular accident, recent major surgery, overt signs of bleeding, uncontrolled hypertension or bacterial endocarditis. B Renal insufficiency. Monitor APTT levels 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.
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 WARFANT
HAEMORRHAGE 2.7 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, 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.
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.
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, 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 ZIBOR Helsinn Birex thrombolytic therapy: 10mg/kg by IV inj. DIC: See 2NO SPC. Renal Impairment: Reduce dose, see SPC. Antithrombotic. Bemiparin Na+ 2500 IU anti Factor Q 25mg/kg/dose. Xa/0.2ml, 3500 IU anti Factor Xa/0.2ml. Soln for inj. D Thromboembolic disease, subarachnoid in pre-filled syringe. 10 syringes/pack. 2500 IU, haemorrhage. A17.72; 3500 IU, A30.23. 2.7 HAEMORRHAGE B Caution: Haematuria of the urinary S Prevention of thromboembolic disease tract. Patients with high risk of thrombosis. in patients undergoing general and orthopaedic BENEFIX Wyeth Pregnancy (unless essential), lactation. surgery. Prevention of clotting in the A Nausea, vomiting, diarrhea. 2 J N extracorporeal circuit during haemodialysis. P General surgery: Admin. 2,500 IU by SC Recombinant coagulation factor IX. Nonacog alfa DDAVP DESMOPRESSIN Ferring with antihaemophilic factor activities of 250 IU, inj., 2 hours before or 6 hours after surgery. On 2JN 500 IU, 1000 IU Powder and solvent for soln for subsequent days admin. 2,500 IU by SC inj. every inj. 250 IU-1; 500 IU-1; 1000 IU-1. Price on request. Vasopressin analogue. Desmopressin acetate 4mcg/ 24 hours for at least 7-10 days. Orthopaedic AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
71
2.8 HYPERCHOLESTEROLAEMIA ml. Amp. 10 x 1ml, A134.12. S In the control of bleeding in patients with mild to moderate haemophilia and von Willebrandâ&#x20AC;&#x2122;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 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).
CIRCULATORY SYSTEM
LIPIDAEMIC
inj. Flushes, sweating, cyanosis.
hypothyroidism, history of hereditary muscular disorders, alcohol abuse, elderly q70. Discontinue 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 body weight. Vol. inj. (ml): Dose in mcg x 1ml/ Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink, 500mcg. Increase by increments of 1mcg/kg until light yellow, light green tabs. marked 771, 7201, 9 platelet count r 50 x 10 /l. Assess weekly until 7202 resp. on one side. All round shallow convex, 9 marked 93 on reverse. 10mg-30, A13.00; 20mg-30, stable (r 50 x 10 /l for at least 4 weeks without A24.98; 40mg-30, A31.27. dose adjustment) then monthly thereafter. Max. 10mcg/kg once weekly. Dose adjustment: See SPC. S Primary hypercholesterolemia (HC) or D Pregnancy (unless clearly necessary). mixed dyslipidaemia, as adjunct to diet, when Lactation (assess risk/benefit). response to diet inadequate. Moderate or severe B Renal / hepatic impairment, elderly. HC in patients at high risk of 1rst cardiovascular Increased risk of bleeding upon discontinuation. event, as adjunct to diet. History of MI or unstable Increased bone marrow reticulin (assess angina pectoris in patients with normal or morphological changes in blood cells). Do not use increased cholesterol levels, as adjunct to for treatment of thrombocytopenia due to MDS or correction of other risk factors. Post KOGENATE BAYER Bayer Schering any other cause other than ITP. Theoretical risk for transplantation hyperlipidaemia in patients 2N thrombotic/ thromboembolic complications and receiving immunossuppressive therapy following Recombinant coagulation Factor VIII (rDNA) (bhk). loss of response to romiplostim. Alterations in solid organ transplantation. Octocog alfa with antihaemophilic factor activities blood cell parameters. P HC: 10-40mg once daily preferably in of 250 IU, 500 IU, 1000 IU. Powder in single-dose C Caution: Other drugs for treatment of the evening. Full effect within 4 weeks. Max. 40 vial with self contained, needle-less reconstitution ITP (monitor), corticosteroids, danazol, and mg daily. Cardiovascular prevention: 40mg daily. device (BIO-SET). 250 IU-1, A272.50; 500 IU-1, azathioprine. Post transplantation: Initially 20mg a day; can be A545.00; 1000 IU-1, A1090.00. A Headache, dizziness, paraesthesia, adjusted up to 40mg. S Treatment and prophylaxis of bleeding migraine, GI disorders, skin disorders, pulmonary Q Heterozygous familial HC: 8-13 years, in patients with haemophilia A (congenital Factor embolism, flushing, insomnia. Bone marrow 10-20mg once daily; 14-18 years, 10-40mg daily. VIII deficiency). disorders, thrombocytopenia. Arthralgia, myalgia, D Pregnancy and lactation. Active liver V Admin. by IV inj (max 2ml/min) or by pain (extremity, back, bone), muscle spasm. disease. continuous inf. according to body weight, severity Fatigue, inj. site reactions, oedema peripheral, B Renal/hepatic impairment, of disorder, site and extent of bleeding, titre of influenza like illness, pain, asthenia, pyrexia, chills, hypothyroidism, history of hereditary muscular inhibitors and factor VIII level desired. See SPC. contusion. disorders or liver disease, alcohol abuse, children D Hypersensitivity to mouse or hamster before puberty. Discontinue if liver enzymes q3x 2.8 HYPERCHOLESTEROLAEMIA protein. As Kogenate does not contain von ULN. Risk of myalgia/myopathy; monitor creatine Willebrand Factor, not for use in von Willebrand LIPIDAEMIC kinase (CK) if predisposing factors or if symptoms disease. occur (discontinue if CK levels q 5xULN). Contains B Hypersensitivity and anaphylactic shock. BELLPRAV Ranbaxy lactose. Monitor for the formation of neutralising C Fibrates (avoid). Caution: antibodies to factor VIII. Pregnancy, lactation (only 2 M O + Cholestyramine (take 1 hr before or 4 hrs after Statin. Pravastatin (Na ) 10mg, 20mg, 40mg. Dark if clearly indicated). resin), colestipol, cyclosporin, erythromycin, yellow to yellow coloured mottled, circular, clarithromycin, nicotinic acid. KONAKION Roche biconvex tabs. marked with P1, P2 and P3 resp. on one side. 20mg and 40mg with breakline on 2NO reverse. 10mg-30, A13.03; 20mg-30, A25.13; Vit. K deriv. Phytomenadione 10mg/ml. Amps. 10, 40mg-30, A31.54. A4.76. S Primary hypercholesterolemia (HC) or S Treatment of haemorrhage. mixed dyslipidaemia, as adjunct to diet, when P 10-20mg as required. response to diet inadequate. Moderate or severe 2NO HC in patients at high risk of 1rst cardiovascular CRESTOR AstraZeneca ALSO KONAKION MM PAED. Phytomenadione event, as adjunct to diet. History of MI or unstable 2mg per 0.2ml in mixed micelles. Amp. 5, A5.41. 2NO angina pectoris with either normal or increased S Prophylaxis and treatment of Statin. Rosuvastatin (Ca++) 5mg, 10mg, 20mg, cholesterol levels as an adjunct to correction of haemorrhagic disease of the new born. 40mg. Film-ctd tabs. marked ZD 4522 and other risk factors. Post transplantation Q Prophylaxis: initially 2mg orally at birth, hyperlipidaemia in patients receiving strength. 5mg, round yellow. 10mg, 20mg, round then 2mg at 4-7 days. In exclusively breast-fed immunossuppressive therapy following solid organ pink. 40mg, oval pink. 5mg-28, A18.22; 10mg-28, babies a further 2mg oral dose should be given at transplantation. A22.41; 20mg-28, A36.56; 40mg-28, A37.56. 1 month. Monthly 2mg oral doses are advised S Primary hypercholesterolaemia (HC) incl. P HC: 10-40mg once daily preferably in until formula fed. Treatment: initially 1mg IV and the evening. Full effect within 4 weeks. Max. heterozygous familial HC, homozygous familial further doses as required; see SPC. Preterm and 40mg daily. Cardiovascular prevention: 40mg daily. HC, or mixed dyslipidaemia in patients special risk neonates; see SPC. unresponsive to diet and other nonPost transplantation: Initially 20mg a day; can be A Anaphylactoid reactions may occur with adjusted up to 40mg. Significant hepatic/renal pharmacological measures. P Initially 5mg or 10mg once daily (incl. impairment: Initially 10mg daily. PRESCRIBING NOTES INFUSIONS patients switched from other statins). Starting Q Under 18 years, not recommended. Intravenous infusions are prohibited except for dose of 5mg recommended for: Patients q70 D Pregnancy, lactation. Active liver those legitimately received in the course of years, moderate renal impairment, Asian ancestry, disease. hospital admissions or clinical investigations. predisposing factors to myopathy. If necessary, B Renal/hepatic impairment,
72
NPLATE
Amgen
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 -
controlled with a statin alone, or already treated with a statin and ezetimibe. P 10/20mg/day or 10/40mg/day as single dose in the evening. 10/80mg dose only 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. 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 LESCOL XL Novartis with statin where statin alone is ineffective, or as 2MO monotherapy where statin is inappropriate; Statin. Fluvastatin (as Na+) 80mg. Yellow homozygous familial hypercholesterolaemia as prolonged release tab. marked LE one side, NVR combination therapy with statin with or without on reverse. 28 (Cal/Pk), A22.72. adjunctive treatments (e.g. LDL apheresis); 2MO homozygous sitosterolaemia (phytosterolaemia). ALSO LESCOL Fluvastatin (as Na+) 20mg, 40mg. P 10mg daily with or without food. Coadmin. with statin: Use usual initial statin dose, or Brown/yellow caps. marked with XU, strength and company logo. 20mg-28 (Cal/Pk), A14.55; 40mg-28 continue established higher statin dose. (Cal/Pk). A17.16; 40mg-56 (Cal/Pk), A32.15. Q 10 years or under, not recommended. D When co-admin. with statin: Pregnancy, S Adjunct to diet for the reduction of elevated total and LDL cholesterol in patients with lactation, active liver disease or unexplained primary hypercholesterolaemia (HC) and mixed persistent elevations in serum transaminases. dyslipidaemia (Frederickson Types IIa and IIb). B Moderate or severe liver dysfunction P 40mg or 80mg once daily at night (not recommended). Perform liver function tests swallowed whole with water with or after meal. when starting co-admin. with statin. Monitor for signs of myopathy. Lactation (not recommended), Titrate to lowest effective dose at 4-week intervals. Range, 20-80mg. pregnancy (no data). Contain lactose. Q Over 9 years with familial HC: Initially C Fibrates, possible risk of cholelithiasis 40mg once daily; titrate to 80mg if necessary; and gallbladder disease. Caution: Ciclosporin, 20mg may be adequate in mild cases. Under 9 coumarin anticoagulants or fluindione (monitor years: Not recommended. International Normalised Ratio). Bile acid sequestrant (e.g. cholestyramine), admin. at least 4 D Active liver disease or persistent unexplained elevation of transaminase levels, hrs before or 2 hrs after ezetimibe. cholestasis. Myopathic disorders. Caution if history A Headache, GI disorders. Also fatigue of liver disease, high alcohol consumption. and myalgia when co-admin. with statin. 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 marked elevated creatine phosphokinase (CPK) to off-white cap.-shaped tab. with code 312, 313, values due to myopathy, myositis or A A or 315. 10/20mg-28, 42.00; 10/40mg-28, 49.00; rhabdomyolysis; discontinue. 10/80mg-28, A51.80. C Cholestyramine (admin. min. 4 hrs S As adjunctive therapy to diet in primary before Lescol). Caution: Rifampicin, warfarin, hypercholesterolaemia (HC) or mixed immunosuppressants (incl. cyclosporin), gemfibrozil, nicotinic acid, erythromycin, hyperlipidaemia in patients not appropriately
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 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.
LIPIDAEMIC
2.8
glibenclamide. A Dyspepsia, abdominal pain, nausea, insomnia, headache.
LIPANTIL MICRO
Solvay
2MO Fibrate. Fenofibrate (micronised) 200mg, 67mg. Orange cap. and yellow cap. resp. 200mg-30, A18.32; 67mg-90,A18.85. S Hyperlipidaemia resistant to diet. P 3 x 67mg daily in divided doses or 1 x 200mg daily with food. Q Not recommended. D Severe renal or hepatic dysfunction, gall bladder disease, biliary cirrhosis. Photoallergy or 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.-
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
73
2.8 HYPERCHOLESTEROLAEMIA -
CIRCULATORY SYSTEM
LIPIDAEMIC
C Cyclosporin, fibrates, macrolide antibiotics, azole antifungals, niacin, drugs metabolised by cytochrome P450 3A4, digoxin, erythromycin, oral contraceptives, colestipol, antacids, warfarin, protease inhibitors. A GI disturbances, headache, myalgia, asthenia, insomnia. Elevated serum transaminases and CPK levels.
muscular toxicity with a statin or fibrate, alcohol abuse, elderly (if other predisposing factors present). May occur: Myopathy (rarely), myositis and rhabdomyolysis (very rarely); advise patients to promptly report if occur; stop treatment if CK levels q5 x ULN. If symptoms are severe and cause daily discomfort, consider discontinuation even if CK levels Q5 x ULN. Homozygous familial hypercholesterolemia: Not recommended. LIPOSTAT BMS C Caution: Fibrates, niacin, colchicine, ciclosporin, warfarin and other coumarin 2MO derivatives, rifampicin (long-term), glibenclamide Statin. Pravastatin (as Na+ salt) 10mg, 20mg, 40mg. Lemon oval scored tabs. marked 10, 20 and (monitor patients on 80mg/day fluvastatin), bile acid sequestrants (e.g. cholestyramine; admin. 40 resp. 10mg-28 (Cal/Pk), A12.49; 20mg-28 (Cal/ fluvastatin at least 4 hrs after), fluconazole, Pk), A24.00; 40mg-28 (Cal/Pk), A30.00. phenytoin. S Primary hypercholesterolaemia (HC)or A Insomnia, headache, fatigue, dizziness, mixed dyslipidaemia, as adjunct to diet where GI disorders, arthralgia. response to diet and other non-pharmacological measures has been inadequate. Adjunct to diet to LOPID Pfizer prevent cardiac events in patients with HC and at 2MO high risk. Adjunct to correction of other risk factors in patients with history of MI or unstable Fibrate. Gemfibrozil 300mg. White/maroon cap. angina regardless of cholesterol levels. Reduction marked Lopid 300. 112, A31.93. of post transplantation hyperlipidaemia in patients 2 M O receiving immunosuppressive therapy. ALSO LOPID TABLETS 600MG Gemfibrozil 600mg. P HC: Usual range, 10-40mg once daily at White elliptical film-ctd scored tab. marked LOPID bedtime. Full effect within 4 weeks. Cardiovascular on one side. 56, A31.93. prevention: 40mg daily. Post transplantation: S As adjunct to diet and exercise in: Initially 20mg daily; max. 40mg daily. Renal/ Mixed dyslipidaemia; primary hepatic impairment: Initially 10mg daily. hypercholesterolaemia, particularly when a statin Q Heterozygous familial HC: 8-13 years, is inappropriate/not tolerated; reduction of 10-20mg once daily; 14-18 years, 10-40mg daily. cardiovascular morbidity in males with increased D Active liver disease. Pregnancy, non-HDL cholesterol and at high risk for a first cardiovascular event, particularly when a statin is lactation. inappropriate/not tolerated. B Hepatic disease. Withdraw if ALT and P Usually 600mg twice daily, although AST q3xULN and persist. Measure CK prior to 900mg daily may be sufficient. Mild-moderate therapy in patients at risk of myopathy. Monitor renal impairment: Start treatment at 900mg daily. for signs of myopathy (interrupt if severe symptoms or CKq5xULN). Children before puberty Q Not recommended. D Hepatic dysfunction, severe renal (evaluate benefit/risk). Dizziness and visual impairment, pre-existing gall bladder or biliary disturbances may occur. tract disease, incl. gallstones. History of LIPITOR Pfizer C Fibrates (avoid). Take 1 hr before or 4 photoallergy or phototoxic reaction during hrs after cholestyramine or colestipol. Caution: 2MO treatment with fibrates. Pregnancy, lactation. Cyclosporin, erythromycin, clarithromycin. Statin. Atorvastatin 10mg, 20mg, 40mg, 80mg. B Myositis, myopathy and elevated CPK A Uncommon. White elliptical film-ctd tabs. marked with code have been reported. Rhabdomyolysis has been and tab. strength. 10mg-28, A21.39; 20mg-28, LOCHOL Clonmel reported rarely. Measure CPK levels before A33.74; 40mg-28, A56.43; 80mg-28, A65.09. combination with statins in patients with pre2MO S Adjunct to diet in primary disposing factors for rhabdomyolysis. Perform lipid Statin. Fluvastatin 20mg, 40mg. Resp. size 3 or 1 hypercholesterolaemia, heterozygous familial hard cap. with blue or green cap and white body. profile, blood count and liver functon tests before hypercholesterolaemia, mixed hyperlipidaemia. treatment. Check blood count every 2 months 20mg-28, A7.56; 40mg-28, A8.92. Homozygous familial hypercholesterolaemia as during first 12 months of treatment. Monitor S Primary hypercholesterolaemia and adjunct to other lipid-lowering treatments or if mixed dyslipidaemia (Fredrickson Types IIa and IIb) serum lipids periodically. Discontinue if persistent such treatments are unavailable. Raises HDLliver function abnormality. as adjunct to diet to reduce elevated total cholesterol and lowers LDL/HDL and total cholesterol and low-density lipoprotein cholesterol C Contraindicated: Repaglinide. Avoid cholesterol/HDL ratios. Prevention of statins. Caution: Rosiglitazone, oral anticoagulants. cardiovascular events in patients estimated to have when response to diet and other nonBexarotene, not recommended. Admin. resinpharmacological treatments is inadequate. a high risk for a first cardiovascular event, as granule drugs e.g. colestipol 2 hours apart. P Before treatment start cholesteroladjunct to correction of other risk factors. A Vertigo, headache, GI disorders, eczema, lowering diet and continue during treatment. P Initially 10mg once daily, increase as Initially 20mg to 40mg daily. May be increased to rash, fatigue. necessary at 4 week intervals; max. 80mg once 80mg (max). Max lipid-lowering effect is achieved daily. LUVINSTA Actavis within 4 weeks. Q Severe dyslipidaemias in 4-17 years: 2MO Q Under 18 years, not recommended. 10mg per day. May be increased to 80mg daily. Statin. Fluvastatin (as Na+) 20mg, 40mg. Resp. D Active liver disease, or unexplained, No developmental safety data available. orange/ivory or orange/yellow opaque hard cap. persistent elevations in serum transaminases. D Active liver disease, persistent raised marked with FST and strength. 20mg-28, A10.93; Pregnancy, lactation. liver enzymes (q 3xULN), myopathy. Pregnancy, 40mg-28, A12.89. lactation. Ensure adequate contraception. B Monitor liver function before and B History of alcohol abuse or liver disease. periodically during treatment; discontinue if S Primary hypercholesterolaemia and Perform liver function tests before treatment, at mixed hyperlipidaemia (Fredrickson Types IIa and increase in AST or ALT exceeds 3 x ULN and 12 weeks or elevation of dose and periodically IIb) as an adjunct to diet when response to diet persists. Caution: History of liver disease, heavy thereafter. Myalgia, myopathy, and very rarely and other non-pharmacological treatments is alcohol consumption. Caution (measure CK levels rhabdomyolysis have been reported. Patients with before starting treatment): Renal impairment, inadequate. pre-disposing factors for rhabdomyolysis; monitor hypothyroidism, personal or familial history of P Initially 20mg to 40mg daily in the CPK before therapy, see SPC. Contains lactose. evening. May be increased to 80mg (max). hereditary muscular disorders, previous history of
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 mixed dyslipidaemia, as adjunct to diet, when response to diet and other non-pharmacological treatments is inadequate. Moderate or severe HC in patients at high risk of a 1rst cardiovascular event, as adjunct to diet. History of MI or unstable angina pectoris with either normal or increased cholesterol levels, as adjunct to correction of other risk factors. Post transplantation hyperlipidaemia in patients receiving immunossupressive therapy following solid organ transplantation. P Taken once daily, preferably the 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.
74
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 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 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.
CIRCULATORY SYSTEM
LIPIDAEMIC
(unless essential), lactation. B Do not replace with other nicotinic acid preparations. Substantial alcohol intake, history of liver disease. Monitor liver function. Combined therapy, monitor for signs of rhabdomyolysis. Diabetes, unstable angina, acute phase of MI, surgery. History of jaundice, hepatobiliary disease, or peptic ulcer. May affect platelets count, uric acid and P levels. C Alcohol. Caution: Anti-coagulants, ganglionic blocking agents (e.g. transdermal nicotine or vasoactive drugs), HMG-CoA reductase inhibitors. A Flushing, GI disorders, rash, pruritus.
PRAVASTATIN SODIUM (INN) Teva
2MO Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. 10mg28, A11.24; 20mg-28, A21.61; 40mg-28, A27.00.
PRAVAT
Pinewood
2MO
Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Light pink, light yellow, light green tabs resp. All round, unscored, marked APO on one side and PRA over strength on reverse. 10mg-28, A12.45; 20mg-28, A23.92; 40mg-28, A29.92. S Hypercholesterolaemia (HC) or mixed OMACOR Solvay dyslipidaemia as adjunct to diet when inadequate response to diet. Moderate or severe HC in 2MO 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). Soft, oblong, transparent gelatin caps. containing pectoris regardless of cholesterol levels. Post 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 are insufficient: Type IV in monotherapy; type IIb/ P HC: 10-40mg once daily preferably in the evening. Response seen within a week and full III in combination with statins when control of effect within 4 weeks. Max. 40mg daily. MAXEPA Seven Seas triglycerides is insufficient. P Initially, 2 daily with food; increase to 4 Cardiovascular prevention: 40mg daily. After 2M transplantation: Initially, 20mg daily; may be if necessary. Polyunsaturated fatty acids. Eicosapentaenoic acid Q Not recommended. adjusted up to 40mg. Moderate/severe renal (EPA) 170mg, docosahexaenoic acid (DHA) 115mg. D Pregnancy, lactation (no data). impairment, significant hepatic impairment: Yellow oblong gelatin cap. marked Maxepa. 200, Initially 10mg daily. B Exogenous hypertriglyceridaemia (type 1 A39.97. Q Heterozygous familial HC: 8-13 years, hyperchylomicronaemia); not indicated. Hepatic S Reduction of plasma triglyceride levels 10-20mg once daily; 14-18 years, 10-40mg daily. impairment (monitor hepatic function, especially in patients with severe hypertriglyceridaemia who with high dosage). Patients at high risk of Evaluate benefit/risk in children before puberty. are at special risk of ischaemic heart disease and/ haemorrhage. Moderate increase in bleeding time D Active liver disease incl. unexplained or pancreatitis. Use in conjunction with persistent elevations of serum transaminase may occur with high dosage (i.e. 4 cap.) appropriate dietary measures. C Oral anticoagulants (monitor and adjust elevation (q3xULN). Pregnancy, lactation. P 5 twice daily with food. B Caution: Renal impairment, dose). Q Not recommended. hypothyroidism, previous history of muscular A GI disturbances. D Non-insulin dependent diabetic patients toxicity with a statin/fibrate, history of hereditary with aspirin sensitive asthma. PRAVAMEL Clonmel muscular disorders. Homozygous familial HC (not B Monitor patients with bleeding studied). History of liver disease, heavy alcohol 2MO disorders ingestion. Increased transaminase levels; C Anticoagulants, aspirin, cephalosporins. Statin. Pravastatin (Na+) 10mg, 20mg, 40mg. Pink/ discontinue if q3xULN and persists. Monitor for peach tab. marked 10. Yellow tab. marked 20. A Nausea, eructation. signs of myalgia, myopathy; interrupt if CK levels Yellow tab. marked 40. All cap. shaped film-ctd. q5xULN or if severe symptoms. Dizziness when NIASPAN Abbott 10mg-30. A11.02; 20mg-30, A21.18; 40mg-30, driving vehicles or operating machines. Contains A26.46. lactose. 2MO C Fibrates (avoid), bile acid-binding resins S Primary hypercholesterolaemia (HC) Nicotinic acid. Nicotinic acid 375mg, 500mg, (admin. 1 hr before or min 4 hrs after resin). when response to diet and other non750mg, 1000mg. White to off-white cap.-shaped Caution: Ciclosporin, erythromycin or pharmacological treatments is inadequate, tab. marked with strength on one side. 375mg-7, clarithromycin. moderate or severe HC in patients at high risk of A4.19; 500mg-7, A5.58; 750mg-7, A8.38; 500mg1st cardiovascular event (as adjunct to diet). 56, A21.24; 750mg-56, A33.65; 1000mg-56, PRAVITIN Rowex History of MI or unstable angina pectoris with A38.27. normal or increased cholesterol levels (as adjunct 2MO S Dyslipidaemia, particularly combined + to other risk factor correction). Post transplant Statin. Pravastatin (Na ) 10mg, 20mg, 40mg. mixed dyslipidaemia, primary hyperlipidaemia reduction in patients on Yellow, oval, convex, side wall scored tab. marked hypercholesterolaemia. In combination with immunosuppressive therapy following solid organ P10, P20 or P40. 10mg-30, A13.38; 20mg-30, statins, when statin monotherapy is inadequate. transplantation. A25.67; 40mg-30, A32.12. As monotherapy only in patients who do not P HC: 10-40mg daily, preferably in the S Primary hypercholesterolaemia (HC) or tolerate statins. evening; max. 40mg daily. Cardiovascular mixed dyslipidaemia, as adjunct to diet when no P (Week1) 375mg once daily, (week2) prevention: 40mg daily. After transplantation: response to dietary measures. Reduction of titrate to 500mg, (week3) 750mg, (week 4-7) Initially, 20mg daily; may titrate up to 40mg. cardiovascular mortality and morbidity: a) patients 1000mg (two 500mg tabs.), all once daily at Moderate to severe renal impairment: Initially with moderate or severe HC and at high risk of bedtime after low-fat snack. Maintenance dose: cardiovascular event as adjunct to diet; b) patients 1000mg (two 500mg tabs.) or 1500mg (two 750mg 10mg daily. Q Under 18 years, not recommended. with history of MI or unstable angina pectoris as tabs.) or 2000mg (two1000mg tabs.), all once adjunct to correction of other risk factors. daily. Do not increase by more than 500mg in any D Active liver disease. Pregnancy, lactation. Reduction of post transplantation hyperlipidaemia 4-week period after initial titration to 1000mg. B Elevated serum transaminase and/or in patients receiving immunosuppressive therapy Max., 2000mg per day. Tab. strengths not creatine kinase levels (monitor). Renal impairment, following solid organ transplantation. interchangeable. hypothyroidism, liver disease (history), heavy P HC: 10-40mg once daily preferably in Q Children and adolescents, not alcohol ingestion. Risk of myopathy, myalgia. the evening. Full effect within 4 weeks. Adjust recommended. C Fibrates, cholestyramine, colestipol, dosage according to periodic lipid determination. D Significant hepatic dysfunction, active Max. daily dose, 40 mg. Cardiovascular prevention: cyclosporin, erythromycin, clarithromycin. peptic ulcer disease, arterial bleeding. Pregnancy
76
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 -
LIPIDAEMIC
2.8
80mg daily as a single dose at night. CHD: Initially 20mg once daily at night 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. Pregnancy or women trying to become pregnant or suspect pregnancy, lactation. Porphyria, SIMATOR Pinewood myopathy. B History of liver disease, alcoholism, renal 2MO impairment, hypothyroidism, history of hereditary Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. All film-ctd tabs. marked SV 10, SV 20, SV 40 or SV 80 muscular disorders or muscular toxicity with a statin or fibrate. Perform liver function tests resp. on one side and qq on the other. 10mg, before and during therapy. 40mg: Shield-shaped, pink tab.; 20mg: Round, C Digoxin, coumarin anticoagulants, orange tab. with a score line. 80mg: Capsulecyclosporin, gemfibrozil and other fibrates, shaped, pink tab. 10mg-28, A13.75; 20mg-28, nicotinic acid derivatives, azole antifungals, A23.39; 40mg-28, A23.39; 80mg-28, A23.39. S CHD: In patients with plasma cholesterol macrolide antibiotics, HIV treatments, amiodarone, r5.5mmol/L. Hyperlipidaemia: Adjunct to diet for verapamil. A Abdominal pain, constipation, reduction of total and LDL-cholesterol, QUESTRAN BMS apolipoprotein B and triglycerides in patients with flatulence, nausea. Headache, indigestion, diarrhoea, rash, itch, asthenia. Rarely myopathy. 2MO primary hypercholesterolaemia, combined hyperlipidaemia when response to diet is Bile acid sequestrant. Cholestyramine 4g. Powder SIMVASTATIN BENTLEY Bentley in sachet. 50, A24.32. inadequate. 2MO P CHD: Initially 20mg/day, adjusted if S Type II hyperlipoproteinaemias. Statin. Simvastatin 10mg, 20mg, 40mg. Oval, P 12-24 g daily in divided doses; max. 36g necessary at intervals r 4 weeks, to max. of biconvex, film-ctd tabs. 10mg: Peach scored 40mg/day, or exceptionally 80mg/day. daily. marked 0 on each side of scoreline. 20mg and Q Under 6 years, not recommended; over Hyperlipidaemia: Recommended dose, 10mg/day. Dose range, 10 to 80mg/day. In combination with 40mg: Tan-coloured and brick red marked 20 and 6 years, in proportion to dose for 70kg adult. 40 resp. 10mg-28, A10.20. 20mg-28, A17.35. ciclosporin, fibrates or niacin: Max. dose, 10mg/ D Complete biliary obstruction. 40mg-28, A17.35. B On long term, suppl. diet with vitamins day. Take all daily doses as single doses in the S Cardiovascular prevention in manifest A, D and K. Pregnancy, lactation. Contain sucrose. evening. Standard cholesterol lowering diet atherosclerotic CVD or diabetes mellitus with recommended before and during treatment. C Digitalis, antibiotics, diuretics. Take all Reduce dosage if LDL-cholesterol levels fall below either normal or increased cholesterol levels. As drugs 1 hour before or 4-6 hours after Questran. adjunct to diet for treatment of primary 1.96mmol/l or total serum cholesterol levels fall A Constipation. hypercholesterolaemia (HC), familial below 3.6mmol/l. Renal Insufficiency: Doses RITECHOL Niche q10mg/day, caution. hypercholesterolaemia (FHC) or mixed dyslipidaemia, when no response to diet. Q Under 18 years, not recommended (no 2MO P CVD prevention: 20-40mg/day as single Statin. Simvastatin 10mg, 20mg, 40mg. Oval, tabs. data). dose in the evening. Hyperlipidaemia: D Active liver disease or unexplained marked 10 and 20 resp. on one side; round tab. persistent elevation of serum transaminase values. Recommended, 10mg once daily in the evening; plain on one side (40mg). All white, film-coated range 10-80mg. Results within 2 weeks; max. Porphyria, myopathy. Pregnancy, lactation. with a breakline on the reverse. 10mg-28, A12.84; response by 4-6 weeks. Homozygous FHC: 40mg/ Women of child bearing age (unless adequate 20mg-28, A21.82; 40mg-28, A21.82. day in the evening or 80mg/day in 3 divided doses S Hypercholesterolaemia: Adjunct to diet contraception used). of 20mg, 20mg and evening dose of 40mg. Max. for reduction of elevated total and LDL-cholesterol B Risk of myopathy. Monitor liver dose 10mg/day if admin. with ciclosporin, fibrates function. Impaired renal function. Tabs. contain in patients with hypercholesterolaemia (type IIa) or niacin. lactose. or combined hyperlipidaemia (type IIb) when Q Not recommended. C Ketoconazole, itraconazole and HIVresponse to diet and other non-pharmacological D Active liver disease, persistant elevation protease inhibitors, delaviradine, mibefradil. measures is inadequate. CHD: Secondary of serum transaminases, porphyria. Pregnancy, Caution: Gemfibrozil and other fibrates, niacin, prevention in patients with elevated plasma lactation. potent inhibitors of CYP3A4, telithromycin, cholesterol (q5.5mmol/L). B Perform liver function tests before and coumarin anticoagulants, digoxin. Avoid P Hypercholesteroleamia: Initially 10mg during therapy. Increased risk of myopathy; grapefruit juice. once daily at night, adjusting at min. 4-week discontinue if severe symptoms occur, or if CK A GI disturbances. intervals according to response. Usual range 10levels are q 5 x ULN. Check CK levels prior to 40mg daily as a single dose at night. CHD: Initially SIMTAN Clonmel therapy if: History of muscular disorders, 20mg once daily at night adjusting at min. 4-week alcoholism, renal impairment, uncontrolled 2MO intervals according to response; max. 40mg daily hypothyroidism, elderly (q 70 years). Contains Statin. Simvastatin 5mg, 10mg, 20mg, 40mg. as single dose at night. Yellow (5mg) and white oblong biconvex film-ctd. lactose. Q Under 18 years, not recommended. tabs. scored on one side and marked SVT5, SVT10, C Contra: Potent CYP 3A4 inhibitors (see D Active liver disease or unexplained SVT20 and SVT40 resp. 5mg-28, A11.78; 10mg-28, annexe). Avoid grapefruit juice, gemfibrozil, other persistent elevation of serum transaminases. fibrates, niacin, less potent CYP 3A4 inhibitors, A11.87; 20mg-28, A20.15; 40mg-28, A20.15. Pregnancy, lactation. Women of child-bearing S Hypercholesterolaemia: Adjunct to diet danazol (unless benefit outweighs risk). Caution: potential unless adequate contraception is used. for reduction of elevated total and LDL-cholesterol Coumarin anticoagulants. Porphyria, myopathy. B History of liver disease, alcoholism, renal in patients with hypercholesterolaemia (type IIa) SIMZOR Gerard impairment, hypothyroidism, history of hereditary or combined hyperlipidaemia (type IIb) when 2MO response to diet and other non-pharmacological muscular disorders or muscular toxicity with a Statin. Simvastatin 10mg, 20mg, 40mg. White to measures is inadequate. CHD: Secondary statin or fibrate. Elderly (q70 years). off-white film-ctd oblong scored tabs. 10mg-30, prevention in patients with elevated plasma Rhabdomyolysis. Perform liver function tests A13.78; 20mg-30, A23.42; 40mg-30, A23.42. cholesterol (q5.5mmol/L). before and during therapy. Significantly elevated P Hypercholesterolaemia: Initially 10mg S Reduction of elevated plasma and LDLCK levels (q5xULN), treatment should not be once daily at night, adjusting at min. 4-week cholesterol in patients with hypercholesterolaemia started. intervals according to response. Usual range 10and combined hyperlipidaemia in combination C Digoxin, coumarin anticoagulants, 40mg daily. Following organ transplantation: Initially 20mg a day; can be adjusted up to 40mg. Renal or hepatic impairment: Initially, 10mg a day and adjusted according to response of lipid parameters. Concomitant therapy: Lipid lowering effects enhanced when combined with bile acidbinding resin (1 hr before or at least 4 hrs after resin). Patients taking cyclosporin: Initially, 20mg once daily; titration to 40mg with caution. Q Under 18 years, not recommended. D Pregnancy and lactation. Active liver disease. B Renal impairment, hypothyroidism, history of hereditary muscular disorders or liver disease, alcohol abuse. Discontinue if: Liver enzymes q3x normal upper limit (ULN); CK levels q5x ULN or if myopathy suspected. C Fibrates. Caution: Cholestyramine, colestipol, cyclosporin, erythromycin, clarithromycin.
cyclosporin, gemfibrozil and other fibrates, nicotinic acid derivatives, azole antifungals, macrolide antibiotics, HIV-protease inhibitors, delaviridine, amiodarone, verapamil, nefazodone, grapefruit juice. A Abdominal pain, constipation, flatulence, nausea. Headache, indigestion, diarrhoea, rash, itch, asthenia. Rarely myopathy.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
77
2.9 ERYTHROPOIESIS,
CIRCULATORY SYSTEM
GRANULOCYTOPENIA
off-white modified-release tabs, with 552 debossed on 1 side. 28, A16.79; 56, A33.59. S Dyslipidaemia, particularly mixed dyslipidaemia and primary hypercholesterolaemia. In combination with HMG-CoA reductase inhibitors (statins), when HMG-CoA reductase inhibitor monotherapy inadequate. As monotherapy only if HMG-CoA reductase inhibitors inappropriate or not tolerated. P Initially, 1 tab. once a day for 4 weeks. Maintenance: 2 tabs. once daily. If dose missed for q7 consecutive days, resume therapy at 1 tab. daily for 1 week before advancing to maintenance dose. Switching from r2000mg prolonged-release nicotinic acid, initiate at maintenance dose. Switching from Q2000mg prolonged-release nicotinic acid and switching from immediaterelease nicotinic acid, initiate at starting dose and advance to maintenance dose after 4 weeks. Take whole with food, the evening or at bedtime. Avoid alcohol or hot drinks 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 blocking agents, 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 A Elevations in ALT and/or AST, fasting cholesterol levels. glucose, uric acid. Dizziness, headache, P Usual initial dose 10-20mg for high paraesthesia, diarrhoea, dyspepsia, nausea, cholesterol and 20-40mg for CHD as single dose in vomiting, erythema, pruritus, rash, urticaria, the evening. Dosage adjustment at min. 4 week flushing, feeling hot. intervals. May be increased to 80mg in exceptional cases as single dose in the evening. Familial ZOCOR MSD homozygous HC: 40mg in the evening or 80mg in 2MO 3 divided doses. Severe renal insufficiency: Caution Statin. Simvastatin 10mg, 20mg, 40mg, 80mg. with daily doses q10mg. Peach oval, tan, red oval and red cap. shaped filmQ Under 18 years, not recommended. ctd tabs. marked ZOCOR 10, ZOCOR 20, MSD 749, D Active liver disease or unexpected one side ’80’ on reverse, resp. 10mg-28 persistent elevation of serum transaminase values, and 543 A (Cal/Pk), 13.79; 20mg-28 (Cal/Pk), A23.43; 40mgporphyria, myopathy. Pregnancy, lactation. A23.43; 80mg-28 (Cal/Pk), A23.43. 28 (Cal/Pk), B Perform liver functions tests before and S As an adjunct to diet for reduction of during therapy. Increased risk of myopathy; elevated total cholesterol, LDL-cholesterol, discontinue if severe symptoms occur, or if CK apoloprotein B and triglycerides in patients with levels q5xULN. Caution: History of muscular primary hypercholesterolaemia, heterozygous disorders or alcoholism, renal insufficiency, familial hypercholesterolaemia or combined uncontrolled hypothyroidism, elderly (q70 years); (mixed) hyperlipidaemia when response to diet check CK levels before initiating therapy. Major and other non-pharmacological measure is surgery (discontinue). Contains lactose. inadequate. To lower LDL/HDL ratio and total C Potent CYP3A4 inhibitors, i.e. cholesterol/HDL ratio by raising HDL.As an adjunct itraconazole, ketoconazole, HIV protease to diet and other non-dietary measures in inhibitors, erythromycin, clarithromycin, reducing elevated total cholesterol, LDLtelithromycin and nefazodone (all cholesterol and apolipoprotein B in patients wihth contraindicated), grapefruit juice (avoid). Caution: homozygous familial hypercholesterolaemia when Gemfibrozil and other fibrates, niacin, other response to these measures is inadequate. CYP3A4 inhibitors, coumarin anticoagulants. P Hyperlipidaemia: Initially 10mg once A GI disturbances. daily at night, adjusting at min. 4-week intervals according to response. Usual range 10-80mg daily TREDAPTIVE MSD as single dose at night. CHD: Initially 20mg daily 2MO as single evening dose adjusting at min. 4-week intervals according to response; max. 80mg daily Nicotinic acid and derivatives. Nicotinic acid, 1000mg; laropiprant, 20mg. Cap.-shaped, white to as single dose at night. Homozygous familial 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 disease 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.
78
hypercholesterolaemia: 40mg as single dose at night or 80mg daily in three divided doses of 20mg, 20mg and 40mg taken in the evening. Q Not recommended. D Active liver disease or unexplained persistent elevation of serum transaminases. Pregnancy or women likely to become pregnant, lactation. B History of liver disease, alcoholism. Perform liver function tests before and during therapy. Dose related risk of myopathy. Contains lactose. C Contra: Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, or nefazodone. Caution: Other inhibitors of CYP3A4, some lipid-lowering drugs (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,
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 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 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 other. 125mg-28, A207.90; 250mg-28, A415.80; 500mg-28, A831.60. S Treatment of chronic iron overload due to frequent blood transfusions (r7ml/kg/month of packed red blood cells) in patients with beta thalassaemia major aged 6 years and older. Treatment of chronic iron overload due to blood transfusions when deferoxamine therapy is contraindicated or inadequate in patients with other anaemias; in patients aged 2 to 5 years; in patients with beta thalassaemia major with iron overload due to infrequent blood transfusions (Q7 ml/kg/month of packed red blood cells). P See SPC. Q See SPC. D Combination with other iron chelator 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.
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.
NEORECORMON
Roche
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 GRANOCYTE Chugai PCV is Q0.5% per week. Weekly dose can be given as one inj. or in divided doses. IV admin. 5NT initially 3 x 40 IU/kg per week. Increasing after 4 Recombinant human granulocyte-colony weeks to 3 x 80 IU/kg per week and if further stimulating factor, rHu G-CSF. Lenograstim. increments are required by 3 x 20 IU/kg per week Powder in vial plus prefilled syringe with WFI. at monthly intervals. Max. 720 IU/kg per week. Granocyte-34: 33.6 MIU/vial. 5 x 1ml vial plus 5 x Maintenance, initially reduce to half previous 1ml pre-filled syringe WFI or inf. Granocyte-13: dose, then adjust to individual requirements at 1 13.4 MIU/vial. 5 x 1ml vial plus 5 x 1ml pre-filled or 2 week intervals. Children, follow syringe WFI or inf. Price available on request. recommended dosing schedule. Solid tumours, by S Non-myeloid malignancy: reduction in SC inj. initially 450 IU/kg per week, this dose may duration of neutropenia and associated be doubled if patient does not show a satisfactory complications following bone-marrow response in terms of haemoglobin values. transplantation or following treatment with Continue therapy for up to 3 weeks after end of cytotoxic chemotherapy associated with significant chemotherapy. Haematological tumours, see SPC. incidence of febrile neutropenia. Granocyte may Autologous blood pre-donation, by IV or SC be admin. to patients with de novo acute myeloid admin. over approx. 2 mins. twice weekly over 4 leukaemia aged above 55 years. Mobilisation of weeks, see SPC. peripheral blood progenitor cells (PBPCs). D Uncontrolled hypertension. For P Cytotoxic-induced neutropenia: 150mcg/ increasing yield of autologous blood if the month m2/day (equiv. 5mcg/kg/day) by SC inj. started on preceding treatment the patients have suffered day after completion of chemotherapy, continue MI, stroke, have unstable angina, are at risk of until neutrophil count stable in acceptable range DVT. (max. 28 days). Bone marrow transplantation: B Hypertension, thrombocytosis. History of 2 150mcg/m /day (equiv. 5mcg/kg/day) by IV inf. started on day after completion of chemotherapy; epilepsy. Chronic hepatic failure. Correct other continue until stable in acceptable range (max. 28 causes of anaemia; iron suppl. may be necessary. days). Mobilisation of PBPCs used alone: 10mcg/kg/ Monitor Hb, BP, platelet count, serum electrolytes. Limit Hb rise to Q2g/dL per month. Theoretically day daily for 4-6 days by SC inj. following adjunctive myelosuppressive chemotherapy 5mcg/ could stimulate malignant growth. Neonates (except NeoRecormon 500). Pregnancy, lactation. kg/day by SC inj. started on day after completion A Hypertension, shunt thrombosis, of chemotherapy until neutrophil count in anaphylactoid reaction, increased platelets. 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, 500mg. Off-white, round, flat dispersible tab. with by SC inj. started on day after completion of Recombinant human granulocyte colony NVR on one face and J125, J250, J500 resp. on the chemotherapy, continue until neutrophil count stimulating factor (G-CSF). Pegfilgrastim 6mg/ AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
79
2.9 ERYTHROPOIESIS,
0.6ml. Pre-filled syringe. 1, A1212.00. S Reduction in the duration of neutropenia and incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy with the exception of chronic myeloid leukaemia, myelodysplastic syndrome and secondary acute myeloid leukemia (AML). P 6mg SC inj. for each chemotherapy cycle 24 hours after cytotoxic chemotherapy. Q Under 18 years, not recommended. D Pregnancy, lactation. B Caution: Patients with AML, sickle cell disease. If preliminary signs of ARDS appear, discontinue. Splenic rupture. Monitor platelet count and haematocrit. Needle cover contains dry natural rubber (may cause allergic reactions). Interpreting bone-imaging results: Consider 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,
80
CIRCULATORY SYSTEM
GRANULOCYTOPENIA 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.
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, RATIOGRASTIM ratiopharm headache, cough, sore throat, GI disorders, elevated GGT, alopecia, skin rash, chest pain, 5NT fatigue, generalised weakness. Mobilisation of Recombinant human granulocyte colony PBPCs: Leukocytosis, thrombocytopenia, elevated stimulating factor (G-CSF) Filgrastim 60MIU/ml. alkaline phosphatise/LDH, headache. SCN patients: Clear, colourless sln for inj. or inf. in pre-filled syringes. 30 MIU/0.5ml-5, A448.37; 48MIU/0.8 ml-5, Anaemia, splenomegaly, thrombocytopenia, decreased glucose, elevated alkaline phosphatase/ A 714.96. LDH, hyperuricaemia, headache, epistaxis, S Reduction in duration of neutropenia diarrhoea, hepatomegaly, alopecia, cutaneous and incidence of febrile neutropenia after vasculitis, injection site pain, rash, osteoporosis. established cytotoxic chemotherapy; reduction in HIV patients: Spleen disorder. duration of neutropenia after myeloablative therapy followed by bone marrow transplantation. RETACRIT Hospira Long term treatment to increase neutrophil counts 5NT (NC) and reduce incidence and duration of infection-related events in patients with severe Erythropoietin. Epoetin zeta. Clear, colourless sln congenital, cyclic or idiopathic neutropenia and 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, history of severe or recurrent infections. A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5mlMobilisation of peripheral blood progenitor cells (PBPC). HIV associated neutropenia. 6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ V Established cytotoxic chemotherapy: 0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; 0.5MIU/kg/day as a daily SC injection or IV infusion 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, A273.01; 40000 IU/1ml-1, A363.97. less than 24 hours following therapy. Bone marrow transplantation: Initially 1MIU/kg/day as S Anaemia associated with chronic renal 30 min or 24 hr IV inf. or by continuous SC inf. failure in adult and paediatric patients on within 24 hrs. Titrate against neutrophil response haemodialysis and adult patients on peritoneal (see SPC). Mobilisation of PBPCs: Alone, 1MIU/kg/ dialysis. Severe anaemia of renal origin with day as 24 hour SC continuous inf. or a single daily clinical symptoms in adult patients with renal SC inj. for 5-7 consecutive days. Leukapheresis: 1 insufficiency not yet undergoing dialysis. Anaemia or 2 on days 5 and 6. PBC mobilisation after and reduction of transfusion requirements in adult myelosuppressive chemotherapy: 0.5MIU/kg/day by patients receiving chemotherapy for solid tumours, SC inj. from 1st day after chemotherapy malignant lymphoma or multiple myeloma, and at completion until neutrophil nadir passed and ANC risk of transfusion as assessed by patientâ&#x20AC;&#x2122;s general in normal range; leukapheresis: When ANC rises status. To increase yield of autologous blood from from Q0.5 x 109/L to q5 x 109/L. Patients who adult surgery patients in a predonation programme (see SPC). have not had extensive chemotherapy, single P Chronic renal failure (haemodialysis): leukapheresis often sufficient. Severe chronic Correction phase, 50 IU/kg IV) thrice weekly; adjust neutropenia: Congenital neutropenia, 1.2MIU/kg/ dose if necessary by 25 IU/kg thrice weekly in steps day SC as single dose or in divided doses. Idiopathic or cyclic neutropenia, 0.5MIU/kg/day SC; of at least 4 weeks. Maintenance total weekly dose 75-300 IU/kg. Chronic renal failure as single dose or in divided doses. Continue until (peritoneal dialysis): Correction phase, 50 IU/kg (IV) ANC at q1.5 x109/L, establish minimum required twice weekly; maintenance, 25-50 IU/Kg (IV) twice to maintain this level. After 1-2 weeks double or weekly. Renal insufficiency without dialysis: half depending on response; adjust every 1-2 Correction phase, 50 IU/kg (IV) thrice weekly; weeks thereafter to maintain average ANC between 1.5 x 109/L - 10 x 109/L. Severe infections, adjust dose if necessary by 25 IU/kg thrice weekly consider faster dose escalation; long-term safety of in steps of at least 4 weeks. Maintenance, 17-33 IU/kg thrice weekly. Cancer patients receiving doses q 2.4MIU/kg/day not established. HIV chemotherapy: Initially 150 IU/kg subcutaneously Infections: Reversal of neutropenia, initially thrice weekly, alternatively 450 IU/kg once weekly. 0.1MIU/kg/day by SC inj. with titration up to max Continue until 1 month after the end of 0.4MIU/kg/day until a normal ANC reached and chemotherapy (see SPC for dose adjustment). maintained (ANC q 2.0 x 109/L). Doses up to Autologous predonation programme: Mildly 1MIU/kg/day may be needed in some patients. anaemic patients (Hct 33-39%) requiring Maintaining normal ANC: Establish minimal effective dose; initial dose adjustment to alternate predeposit of q4 blood units, 600 IU/kg (IV) twice weekly after blood donation procedure for 3 day dosing with 30MIU/day by SC injection. weeks prior to surgery, with adequate iron Further dose adjustment may be necessary supplement. depending on patientâ&#x20AC;&#x2122;s ANC. Long term admin. Q Chronic renal failure (haemodialysis): may be required. Correction phase as per adults. Maintenance, see B Myelodysplastic syndrome, chronic SPC. myelogenous leukaemia: Safety not established. Caution: Secondary AML, underlying osteoporotic D Patients with Pure Red Cell Aplasia (PRCA) following erythropoietin treatment. bone diseases (treatment q 6 months, monitor
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
INSOMNIA 3.1
and G on the other. 10mg-100, A3.73; 20mg-100, A5.74. S Short-term management of insomnia only when severe, disabling or subjecting the individual to extreme distress. Premedication prior to minor surgery or other related procedures. DALMAPAM Pinewood P Insomnia: 10-20mg on retiring or up to 30 mins before bedtime. Exceptionally may be 2NO increased to 30-40mg. Duration, a few days to 2 Long-acting benzodiazepine. Flurazepam (HCl) weeks. Max., incl. tapering-off, 4 weeks. 15mg, 30mg. Ivory/light grey and grey/black hard Premedication: 20-40mg, 30-60 mins before gelatin caps. marked FLU 15 and FLU 30, resp. procedure. 15mg-30, A3.45; 30mg-30, A4.60. 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 Q Under 18 years, not recommended. weeks, max. 4 weeks including tapering off D Myasthenia gravis, severe respiratory process. insufficiency, sleep apnoea syndrome, severe R Reduced dose. hepatic insufficiency. Pregnancy, lactation. Q Not recommended. B Anterograde amnesia may occur. D Myasthenia gravis, severe respiratory Caution: Chronic respiratory insufficiency, impaired insufficiency, sleep apnoea syndrome, severe renal or liver function, history of alcohol or drug hepatic insufficiency. Pregnancy, lactation (unless abuse. Driving/operating machines. Reevaluate essential). when extension beyond max. is necessary. B Great caution: Renal/hepatic 3.1 INSOMNIA Discontinue gradually. impairment, elderly, debilitated, chronic C Alcohol (not recommended). Caution: CIRCADIN Lundbeck pulmonary insufficiency, history of alcohol or drug CNS depressants, antipsychotics, hypnotics, abuse. Anterograde amnesia, psychiatric and 2N anxiolytics/sedatives, antidepressants, narcotic paradoxical reactions, dependence; may occur. analgesics, antiepileptic drugs, anaesthetics and Melatonin 2mg. White to off white round, Withdraw gradually (warn patient about possible A sedative antihistamines, disulfiram, inhibitors of biconvex prolonged-release tabs. 21, 14.51. rebound phenomena). Driving/using machines. cyt. P450. S Short-term treatment of primary Contains lactose. insomnia characterised by poor quality of sleep in C Avoid alcohol. Caution: Antipsychotics, A Drowsiness, numbed emotions, reduced patients aged 55 or over. alertness, confusion, fatigue, headache, dizziness, hypnotics, anxiolytics/ sedatives, antidepressants, P 2mg once daily swallowed whole, 1-2 muscle weakness, ataxia, or double vision. Usually narcotic analgesics, AEDs, anaesthetics and hours before bedtime and after food. Continue transient. sedative antihistamines, P450 inhibitors. for three weeks. A Start: Drowsiness, numbed emotions, Q Under 18 years, not recommended. MOGADON Meda dizziness, confusion, fatigue, headache, muscle B Not recommended: Hepatic impairment, weakness, ataxia, double vision. 2NO autoimmune diseases, pregnancy, lactation, Long-acting benzodiazepine. Nitrazepam 5mg. lactose/sugar intolerance. Caution: Renal HALCION Pharmacia White scored tab. marked ICN. 30, A1.11. insufficiency, driving/using machines. 2NO S Short-term treatment of insomnia when C Avoid alcohol, fluvoxamine. Caution: severe, disabling or subjecting the individual to Short-acting benzodiazepine. Triazolam 0.125mg, Hypnotics, 5 and 8-MOP, cimetidine, smoking, extreme distress. 0.25mg. Lavender ellipitical tab. marked UPJOHN oestrogens, CYP1A2 inhibitors (eg. quinolones), P Elderly, 2.5mg; others, 5-10mg. Both at 10 and blue elliptical flat bevelled edge, single CYP1A2 inducers (e.g. carbamazepine, rifampicin). bedtime. Hospitalised patients; single dose of score tab. marked UPJOHN 17 resp. 0.125mg-30, Potential interaction with adrenergic agonists/ A1.96; 0.25mg-30, A1.73; 250, A14.41. 20mg may be given. antagonists and certain CNS drugs. S Short-term management of insomnia Q Not recommended. A Headache, pharyngitis, back pain, which is severe, disabling or causing extreme D Myasthenia gravis, severe respiratory asthenia. distress. insufficiency, sleep apnoea, severe hepatic insufficiency, phobic or obsessional states, chronic DALMANE Meda P 0.125-0.25mg at bedtime. Max. treatment duration, 4 weeks. psychosis. Pregnancy, lactation. 2NO R 0.125mg. At bedtime. Max. treatment B Tolerance, physical dependence; Long-acting benzodiazepine. Flurazepam (HCl) duration, 4 weeks. withdraw gradually. Do not exceed 4 weeks 15mg, 30mg. 15mg Grey/yellow cap. marked Q Not recommended. without re-evaluation. Anterograde amnesia, ICN15. 30mg black/grey cap. marked ICN30. 15mg- D Myaesthenia gravis, severe respiratory psychiatric reactions may occur. Caution: Children 30, A3.49; 30mg-30, A4.62. or hepatic insufficiency, sleep apnoea syndrome. (duration kept to min.), elderly, history of alcohol/ S Insomnia, when severe and disabling. B Tolerance, dependence & associated drug abuse. Not for treatment of psychotic illness. P 5-30mg at bedtime. Duration: A few withdrawal symptoms. Discontinue if psychiatric Driving/operating machinery. days to 2 weeks, max. 4 weeks. Hospitalised and paradoxical reactions occur. Anterograde C Not recommended: Alcohol. Caution: patients, single dose of 20mg may be given. amnesia may occur. History of alcohol or drug CNS depressants, CYP450 inhibitors. R Max. 15mg abuse. Should not be used alone to treat A Drowsiness, numbed emotions, reduced Q Not recommended. depression or anxiety associated with depression. alertness, confusion, fatigue, headache, dizziness, D Myasthenia gravis, severe respiratory Elderly, children. Pregnancy, lactation (only if muscle weakness, ataxia, double vision. insufficiency, sleep apnoea, severe hepatic considered essential). Driving or using machinery. insufficiency, phobic or obsessional states, chronic NOCTAMID Bayer Schering C Alcohol, CNS depressants. psychosis. Pregnancy, lactation. B Chronic respiratory insufficiency. Driving A Drowsiness, numbed emotions, reduced 2 N O Int.-acting benzodiazepine. Lormetazepam 1mg. or operating machinery, history of alcohol or drug alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia, double vision. White round scored tab. marked in a hexagon abuse. Anterograde amnesia, psychiatric and with CF. Can be divided into equal halves. 30, paradoxical reactions, dependence; may occur. INSOMNIGER Gerard A 3.52 Reevaluate when extension beyond max. is 2 N O necessary. Discontinue gradually. Elderly. S Short-term treatment of insomnia. Benzodiazepine. Temazepam 10mg, 20mg. White- P 1mg at bedtime. C Not recommended: Alcohol. Caution: pale yellow, round, flat beveled-edge scored tabs. R 0.5mg at bedtime. Antipsychotics, hypnotics, anxiolytics/sedatives, marked T/10 and T/20 resp. on the scored side, antidepressants, narcotic analgesics, antiepileptic Q Depends on patient’s age, weight and
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. 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.
drugs, anaesthetics, sedative antihistamines, CYP450 inhibitors. A Drowsiness, numbed emotions, fatigue, reduced alertness, confusion, headache, dizziness, muscle weakness, ataxia, double vision.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
81
3.1 INSOMNIA
CNS
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 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.
apnoea syndrome, myasthenia gravis, severe respiratory insufficiency, psychotic illness. B Renal hepatic or respiratory insufficiency. Depression, history of alcohol or drug abuse. Pregnancy, lactation. Warn of possible drowsiness. C Alcohol, CNS depressants, drugs that inhibit certain hepatic enzymes (particularly cytochrome P450). A Drowsiness, headache, dizziness, numbed emotions, reduced alertness, confusion, vertigo, fatigue, muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, amnesia, depression, psychiatric and paradoxical reactions, dependence.
S Short term treatment of insomnia. P 10mg before retiring. R 5mg before retiring. Q Not recommended. D Obstructive sleep apnoea, myasthenia gravis, severe hepatic or acute pulmonary insufficiency, respiratory depression, psychotic illness. B Hepatic or renal impairment. Depression. History of drug or alcohol abuse. Pregnancy, lactation. Warn of possible drowsiness. C Alcohol, other CNS depressants. A GI upset, dizziness, headache, drowsiness. Very rarely, memory loss, tremor, depression, confusion, perceptual disturbances.
ROHYPNOL
TENOX
Roche
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 2LO dependence; withdraw gradually. Anterograde 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. A2.35; 10mg-28, A4.70. D Severe hepatic insufficiency, sleep
82
Orion
2LO 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
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 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, muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence.
ANXIETY reactions, amnesia.
ZOLNOD
alcohol or drug abuse. C Alcohol, CNS depressants, drugs that Rowex inhibit certain hepatic enzymes (particularly
2NO
Imidazopyridine hypnotic. Zolpidem tartrate 10mg. White scored oblong film-ctd tab. 30, A5.03. S Short term treatment of insomnia. P 10mg daily before retiring. Elderly, 5mg daily. Duration of treatment should be as short as possible, max. 4 weeks. Q Under 18 years, not recommended. D Severe hepatic insufficiency, sleep apnoea syndrome, myasthenia gravis, severe respiratory insufficiency. B Some loss of efficacy may develop after repeated use. Pregnancy, lactation. Reduce dose slowly. C Alcohol, other CNS depressants, antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants, narcotic analgesics, anti-epileptics, sedative antihistamines. ZIMOVANE Meda A Drowsiness, headach, dizziness, numbed 2NO emotions, reduced alertness, confusion, vertigo, GI Cyclopyrrolone. Zopiclone 7.5mg. White scored disturbances (diarrhoea, nausea, vomiting), double film-ctd tab. 28, A6.14. vision, skin reactions, amnesia. 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, D Myasthenia gravis, respiratory failure, A5.15; 7.5mg-28, A5.99 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. Debilitated patients, hepatic insufficiency: 5mg. R 5mg. Q Under 18 years, not recommended. D Severe hepatic insufficiency, sleep apnoea syndrome, myasthenia gravis, severe respiratory insufficiency. Pregnancy, lactation (no data). B Treat cause of insomnia first. Evaluate psychiatric or physical disorder (if no remission after 7-14 days treatment). C Alcohol. Caution: Antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives/ muscle relaxants, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines. A Drowsiness, headache, dizziness, numbed emotions, reduced alertness, confusion, vertigo, GI disturbances, double vision, skin
3.2
DISORDERS
cytochrome P450). A Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision, GI disturbances, changes in libido, skin reactions, bitter taste, amnesia, depression, psychiatric and paradoxical reactions, dependence.
3.2 ANXIETY DISORDERS
ANXICALM
Clonmel
2NO Long-acting benzodiazepine. Diazepam 2mg, 5mg, 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. ZORCLONE Teva marked ’apzm 1’ resp. All tabs. oblong, scored. 2NO 0.25mg-100, A3.38. 0.5mg-100, A6.53. 1mg-100, A13.64. Cyclopyrrolone. Zopiclone 7.5mg. White film-ctd S Anxiety disorders. tab. marked Zoc 7.5 and scored both sides. 28, P 0.25-0.5mg three times daily. Max. 4mg A5.52. daily. S Short-term treatment of insomnia. R 0.25mg two or three times daily. P 7.5mg at night. Q Not recommended. R Initially 3.75mg at night. (Dose also applies to patients with hepatic, renal impairment D See SPC. and chronic respiratory insufficiency). CENTRAX Parke-Davis Q Not recommended. 2NO D Myasthenia gravis, severe respiratory insufficiency, sleep apnoea, severe hepatic Long acting benzodiazepine. Prazepam 10mg. Blue scored tab. marked W and 10. 60, A3.77. insufficiency. Pregnancy, lactation. B Renal, hepatic or respiratory S Anxiety, when the disorder is severe, insufficiency. Patients should not drive or operate disabling or subjecting the individual to extreme machinery until it is established that mental and distress. physical ability has not been impaired. History of P Elderly, 5-15mg daily; others, 10-60mg
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
83
3.2 ANXIETY
CNS
DISORDERS
Q Under 18 years, not recommended. D Liver disease resulting in hepatic impairment, severe renal impairment (ccQ30ml/ 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, 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. Benzodiazepine. Diazepam 5mg/ml. Emulsion for S Panic disorder with or without inj. 10, A7.20. agoraphobia. P 10mg once daily for the 1st week, then S Severe anxiety or agitation incl. delirium tremens; acute muscle spasm including that may be increased to 20mg per day, and up to associated with tetanus; convulsions and status 60mg per day. 1st effects after 2-4 weeks; full epilepticus; pre-operative medication in minor response after up to 3 months. surgery. R 10mg daily. Max. 30mg daily. P By slow IV inj. (1ml/min), IM inj., or inf. Q Under 18 years, not recommended. (min. 4ml/h). Anxiety/agitation: Usually 10mg B Risk of suicide until therapeutic effects repeated 4 hourly. Acute muscle spasm: 0.1-0.3mg/ are achieved. Diabetes, unstable epilepsy, history kg IV repeated every 1-4 hrs as required, or of mania, bleeding disorders, hepatic or severe continuous inf. of 3-10mg/kg every 24 hrs. renal impairment. Driving/operating machines. Convulsions: 10-20mg IV or IM. Status epilepticus, ECT. Lactation, pregnancy (only if essential). initially, 0.15-0.25mg/kg IV repeated in 30 to 60 Withdraw slowly. 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 titrated to patient response. Duration max. 8 not recommended. Caution: CYP2D6 substrates, weeks for anxiety, 4 weeks for insomnia incl. cimetidine, lithium, desipramine, neuroleptics, anticoagulants and drugs increasing bleeding risk tapering off process. R Elderly or debilitated, reduce initial dose (e.g. NSAIDs, antipsychotics, TCAs). by half. A Somnolence, insomnia, agitation, Q Convulsions: 0.2-0.3mg/kg IV or IM (or nervousness, headache, tremor, dizziness, 1mg per year of life). palpitations, nausea, dry mouth, GI disorders, D Myasthenia gravis, severe respiratory increased sweating, abnormal accommodation, insufficiency, sleep apnoea syndrome, severe asthenia, tachycardia, hypotension, hypertension, hepatic insufficiency. Pregnancy, lactation. micturition disorder, polyuria, weight change, B Chronic respiratory insufficiency, history rhinitis, sinusitis, sexual disorders, rash, vision or of alcohol or drug abuse. Not recommended: Use taste abnormalities. in depression, anxiety associated to depression, psychotic illness. Children. Tolerance may develop CYMBALTA Lilly after repeated use. Driving or using machines. 2NO Discontinue gradually. 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, 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 alertness, confusion, fatigue, headache, dizziness, S Generalised Anxiety Disorder. muscle weakness, ataxia, double vision, P Initially 30mg once daily; if insufficient restlessness, agitation, irritability, aggressiveness, response increase to 60mg (usual maintenance delusion, rages, nightmares, hallucinations, dose). Max. 120mg daily. After consolidation of psychoses, inappropriate behaviour. Physical and response, continue treatment for several months. psychic dependence, anterograde amnesia. PreDiscontinue gradually over 1-2 weeks. 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. 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.
84
existing depression may be unmasked. Psychiatric and paradoxical reactions.
EFEXOR XL
Wyeth
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, A3.98; 75mg-28, A22.83; 150mg-28, A38.50. S Generalised anxiety disorder. Social anxiety disorder. Panic disorder, with or without agoraphobia. P Generalised anxiety/social anxiety: 75mg 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.
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 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 Anxiety. P 80mg or 160mg daily. Max. 240mg daily. Q Not recommended.
ANXIETY 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
sweating, ejaculatory delay.
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, LIBRIUM Meda A81.70. S Generalised Anxiety Disorder (GAD). 2NO 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 LEXAPRO Lundbeck cap resp. Both marked LIB and cap. strength 5mg- 300mg, 450mg, and to max. 600mg/day with 1week intervals. Discontinue gradually over a min. 100, A5.37; 10mg-100, A7.47. 2NO of 1 week. Renal impairment: Adjust dosage (see S Short-term treatment of anxiety that is SSRI. Escitalopram (oxalate) 5mg, 10mg, 15mg, SPC). severe, disabling or subjecting the individual to 20mg. Round white film-ctd tab. marked EK and Q Under 18 years, not recommended. unacceptable distress; symptoms of acute alcohol oval white scored film-ctd tabs. marked with EL, D Pregnancy (unless essential), lactation. withdrawal; control of muscle spasm. EM and EN, resp. 5mg-28, A14.00; 10mg-28, P Anxiety: Up to 30mg daily; max. 100mg B Withdrawal symptoms may occur. A22.40; 15mg-28, A33.90; 20mg-28, A44.80. daily. All in divided doses. Alcohol withdrawal: 25- Driving/using machines. Contains lactose. S Major depressive episodes. Generalised C Caution: Ethanol, lorazepam, 100mg repeated if necessary in 2-4 hours. anxiety disorder (GAD). Panic disorder with or antidiabetics (adjust dose). R Do not exceed half adult dose. without agoraphobia. Social anxiety disorder A Dizziness, tiredness. Increased appetite, D Myasthenia gravis, severe respiratory (SAD). Obsessive-compulsive disorder (OCD). weight gain, euphoric mood, confusion, change in insufficiency, sleep apnoea, severe hepatic P Panic disorder: Initially 5mg for 1st libido, irritability, attention disturbances, insufficiency. Pregnancy, lactation. week, may increase to max. 20mg daily. Max. clumsiness, memory impairment, tremor, speech B Tolerance, physical dependence. Caution: effect reached after 3 months. GAD: 10mg once difficulty, paraesthesia, visual disturbances, daily, may increase to max. 20mg. SAD: 10mg once Alcohol/drug abuse (or history of). Withdraw vertigo, dry mouth, GI disorders, erectile gradually. Do not exceed 4 weeks without careful daily. Relief of symptoms 2-4 weeks. Depending dysfunction, peripheral oedema, drunken feeling, on response adjust dose between 5mg-20mg daily. re-evaluation. Anterograde amnesia, psychiatric abnormal gait. reactions may occur. Caution: Children (duration Continue for up to 12 weeks. Depression, OCD: See section 3.4. Reduced hepatic function: Initially kept to min.). Elderly. Not for treatment of STELAZINE Goldshield psychotic illness. Driving/operating machinery. 5mg for 2 weeks, may increase to 10mg. 2MO C Not recommended: Alcohol. Caution: R Over 65 years, initially half adult dose Phenothiazine group III. Trifluoperazine (HCl) 1mg, CNS depressants, CYP450 inhibitors. and lower max. dose. A Drowsiness, numbed emotions, reduced 5mg. Blue sug-ctd tabs. marked SKF. 1mg-112, Q Under 18 years, not recommended. A2.75; 5mg-112, A3.92. B Hyponatraemia observed with SSRI use. alertness, confusion, fatigue, headache, dizziness, 2MO History of mania/hypomania, co-admin. of ECT in muscle weakness, ataxia, double vision. ALSO STELAZINE SYRUP Trifluoperazine (HCl) patients on SSRI’s, bleeding disorders, coronary LUSTRAL Pfizer 1mg/5ml. 200ml, A1.93. heart disease, paradoxical anxiety. Monitor patients with unstable epilepsy, diabetes. S Anxiety states, depressive symptoms 2NO Withdraw gradually. Closely monitor patients for secondary to anxiety, agitation. SSRI. Sertraline (HCl) 50mg, 100mg. White, capsuicide and self harm during initiation of therapy P 2-4mg daily in divided doses. Max. 6mg shaped, film-ctd tabs. marked PFIZER and ZLT-50 (all SSRIs). Driving/using machine. Pregnancy, daily. or ZLT-100 resp. 50mg tab. scored. 50mg-28, lactation. Q Under 6 years, not recommended; 6-12 A21.05. 100mg-28, A31.58. C Contra: Non-selective, irreversible years, up to 4mg daily. All in divided doses. S Panic disorder with or without MAOIs. Reversible MAOI-A (moclobemide), not D Comatose states, bone marrow agoraphobia. Social anxiety disorder. Postrecommended. Caution: Selegiline, lithium, depression, liver damage, existing blood dyscrasia. traumatic stress disorders. tryptophan, St. John’s Wort, drugs lowering P Initially, 25mg daily increasing to 50mg Uncontrolled cardiac decompensation. epilepsy seizure threshold, oral anticoagulants, B Elderly. CVD. Parkinsonism. Pregnancy, daily after 1 week. Dose may be increased in cimetidine, substrates or inhibitors of CYP2C19 50mg increments over a period of weeks, to max. lactation. Epilepsy. (eg. omeprazole), CYP2D6 substrates, other A See SPC. 200mg daily. serotonergic drugs, alcohol. Q Not recommended. STESOLID Actavis A Nausea, sweating, somnolence, fatigue, D Significant hepatic insufficiency. dizziness, insomnia, constipation, diarrhoea, 2NO Pregnancy, lactation. Unstable epilepsy or appetite decrease, sexual dysfunction, pyrexia, Benzodiazepine. Diazepam 2mg, 4mg per ml. convulsant disorders. sinusitis, yawning. 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 LEXOTAN Roche S Acute severe anxiety and agitation, a manic phase. Controlled epilepsy. ECT, not 2NO epileptic and febrile convulsions, tetanus, as recommended. Driving or using machines. Intermediate-acting benzodiazepine. Bromazepam C Contraindicated: MAOIs (or within 14 sedative in minor surgical and dental procedures, 1.5mg, 3mg. Slighly yellow cylindrical tab. marked days), pimozide. Monitor alcohol, lithium, or when rapid effect required but IV inj. Roche 1.5mg and pink cylindrical tab. marked impracticable. warfarin, phenytoin, sumatriptan. Caution: St A A Roche 3 resp. 1.5mg-30, 2.71. 3mg-30, 3.43. P 10mg. Repeat dose if no response John’s wort, diazepam, tolbutamide, cimetidine, within 5 mins. S Short-term treatment of anxiety. TCAs, other centrally acting drugs, other R 5mg. Repeat dose if no response within P 3-18mg daily. Both in divided doses. serotonergic drugs. 5 mins. R 1.5-9mg daily. A Anorexia, insomnia, dizziness, Q 1-3 years, 5mg; over 3 years, 10mg. Q Not recommended. somnolence, tremor, GI disorders, increased
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. Q Not recommended. D See 2.4, b-blockers Drug Presc. Notes. Tabs contain lactose.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
85
3.3 PSYCHOSES
CNS
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 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 dose may be up to 1g daily. Intractable hiccup: 10potentially arrhythmogenic drugs. Young children, ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. 25mg 6 to 8 hourly, increasing to 25-50mg 6-8 elderly, moderate/severe renal impairment (reduce Orodispersible round tab. marked with strength hourly if necessary. Terminal illness: 10-25mg, 4-6 dose). Stop at least 5 days before allergy testing. on one side and A over 640 or 641 resp. on hourly. Contains ethanol, sucrose. Driving or using reverse. 10mg, pink; 15mg, yellow. 10mg-28, R Agitated states: 10-25mg once or twice machines. A141.12; 15mg-28, A141.12. daily. Other conditions: 1/3 to 1/2 usual adult dose C Avoid: MAOIs, alcohol. Barbiturates, S Schizophrenia. Treatment of moderate with gradual titration upward. other CNS depressants, anticholinergics, 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 years, 0.5mg/kg every 4-6 hours to max 40mg/day. cimetidine, CYP2D6 substrates. experienced predominantly manic episodes and 6-12 years,1/3 to 1/2 of adult dose to max of 75mg/day. Terminal illness: 0.5mg/kg every 4-6 VALIUM Roche whose manic episodes responded to aripiprazole. 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, A1.80. 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. monitor regularly. Caution: High doses, elderly, ALSO ABILIFY SOLUTION FOR INJECTION R 3-15mg daily. Aripiprazole 7.5mg/ml. Clear, colourless, aqueous extremes of temperature, CVD, parkinsonism, Q See SPC. epilepsy. Patients with risk factors for ventricular sln for inj. D See SPC. S Rapid control of agitation and disturbed arrhythmias. Establish accurate diagnosis if using to relieve severe vomiting. Pregnancy. Contains behaviours in patients with schizophrenia or in XANAX Pharmacia patients with manic episodes in Bipolar I Disorder, lactose. Driving or using machines (if drowsiness 2NO occurs). when oral therapy is not appropriate. Treatment C CNS depressants, antihypertensives, with aripiprazole solution for inj. should be 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, A3.52; 0.5mg100, A6.77; 1mg-100, A14.13. 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, UCERAX UCB irritability, aggressiveness, delusion, rages, nightmares) 2NO C Alcohol, CNS depressants. Nonbenzodiazepine anxiolytic. Hydroxyzine HCI A Amnesia, drowsiness, depression, 25mg. White, oblong, film-ctd biconvex scored pychiatric and paradoxical reactions, dependence. tabs. 25, A1.31. Repeat dose if no response within 5 mins. 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 associated with depression. Caution: Personality disorders, renal or hepatic dysfunction, chronic pulmonary insufficiency, closed-angle glaucoma. Elderly or debilitated patients. Amnesia, withdrawal symptoms may occur. Do not drive or operate machines. C CNS depressants (avoid), alcohol. A Drowsiness, light-headedness, unsteadiness, ataxia.
86
2
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS B Patients must register with CPMS. Monitor leucocyte counts weekly during first 18 weeks and every 2 weeks thereafter; withdraw immediately if wbc count below 3 x 109/l and/or neutrophil count below 1.5 x 109/l. Patients should report symptoms of infection. Pregnancy; adequate contraception must be used. Monitor patients with a history of epilepsy. Prostatic hypertrophy, narrow angle glaucoma, paralytic ileus. Liver disease. Orthostatic hypotension, cardiovascular, renal or hepatic disorders, transient temperature elevations. CLOPIXOL Lundbeck C Other drugs which cause agranulocytosis, narcotics, benzodiazepines, 2NO Thioxanthene. Zuclopenthixol (HCl) pink tab.;10mg alcohol, CNS depressants, antihistamines, lithium, MAOIs, anticholinergics. Drugs effecting hepatic light brown tab.; 25mg brown tab. All film-ctd enzymes, highly protein bound drugs, cimetidine, tabs. 10mg-100, A8.70; 25mg-100, A17.40. phenytoin, adrenaline, drugs with hypotensive or S Psychoses, especially schizophrenia. P Initially 20-30mg daily in divided doses. respiratory depressant effects, fluvoxamine. A Neutropenia leading to life threatening Maintenance, 20-60mg daily. Max. 150mg daily. agranulocytosis. Drowsiness, fatigue, Q Not recommended. 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. skin reactions, autonomic effects. GI upset. ECG P Usually 200-400mg by deep IM inj. every changes, myocarditis. Seizures, confusion, 2-4 weeks. Max. 600mg a week. restlessness, agitation, delirium. Circulatory Q Not recommended. collapse, respiratory depression or arrest, 2NO aspiration, dysphagia, hyperglycaemia, rarely CPK ALSO CLOPIXOL-CONC. Zuclopenthixol decanoate 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. Dibenzodiazepine. Clozapine 25mg, 50mg, 100mg, 2NO 200mg. 25mg, 50mg, 100mg: Round flat yellow ALSO CLOPIXOL ACUPHASE Zuclopenthixol bevel edged tabs marked with strength over a acetate 50mg/ml. 1ml, 2ml amps. 5 x 1ml, A26.06. 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. 2N D Comatose states, apathy or withdrawal, ALSO DENZAPINE ORAL SUSPENSION Clozapine, pregnancy, lactation. 50mg/ml. Free-flowing yellow susp. 100ml, A95.24. B Intolerance to oral neuroleptic drugs, 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. Lactation. disease. Lactation. anticholinergics, MAOIs, analgesics, antiParkinsonian drugs. Drugs which prolong QT interval. Deferoxamine, lithium, oral hypoglycaemics, insulin. Antacids (admin. 2 hours apart). A Postural hypotension, anticholinergic effects, drowsiness, thermoregulation disorders, weight gain, hyperglycaemia, changes in glucose tolerance, tachycardia, QT interval prolongation, allergic skin reactions, rash, photosensitivity, haematological disorders.
PSYCHOSES 3.3 B Can cause agranulocytosis. Initiation restricted to WBC countq3500/mm3 and neutrophil count q 2000/mm3). Monitor these counts weekly for first 18 weeks and at least 4week intervals thereafter including 4 weeks after complete discontinuation (see SPC). Discontinue immediately if neutropenia or agranulocytosis. Caution: CVD or family history of QT prolongation, risk factor for stroke, liver disorders, prostatic enlargement, narrow-angle glaucoma. Reported: Myocarditis, pericarditis/ pericardial effusion, cardiomyopathy, impairment of intestinal peristalsis, neuroleptic malignant syndrome, hyperglycaemia, thromboembolism. Withdraw 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
87
3.3 PSYCHOSES
CNS
Torsades de pointes, bradycardia or 2nd or 3rd degree heart block, uncorrected hypokalaemia. Pregnancy, lactation. B To exclude unexpected adverse sensitivity, start patients on oral haloperidol. Baseline ECG recommended prior to treatment esp. in elderly and patients with positive personal or family history of cardiac disease or abnormal cardiac clinical findings; ECG monitoring during therapy may be needed. Reduce dose if QT prolonged; discontinue if QTc q 500ms. Rare cases GEODON Pfizer of sudden death reported in patients on antipsychotic drugs (incl. haloperidol). Cardiac 2NO effects reported very rarely. Caution: Risk factors 5-HT2A and dopamine (D2) receptor antagonist. for ventricular arrhythmias (assess risk vs benefit), Ziprasidone (as HCl monohydrate) 20mg blue/ white cap. 40mg blue cap. 60mg white cap. 80mg thyrotoxicosis, phaeochromocytoma, hepatic/renal dysfunction, epilepsy or predisposing conditions, blue/white cap. All marked with Pfizer and ZDX 20, ZDX 40, ZDX 60 or ZDX 80. 20mg-56, A104.01; severe cardiovascular disease, hyperthyroidism, risk factors for stroke. May occur: Hypotension, 40mg-56, A109.48; 60mg-56, A120.43; 80mg-56, hypertension (less common). A158.75. C Contra: Other QT prolonging drugs. S Schizophrenia. P Acute treatment, 40mg twice daily with Caution: Alcohol, hypnotics, sedatives, strong food. Max. 80mg twice daily. Maintenance, lowest analgesics, lithium, levodopa, methyldopa, effective dose, 20mg twice daily may be sufficient. adrenaline and other sympathomimetic agents, adrenergic blocking agents (e.g. guanethidine), Hepatic insufficiency: Consider lower dose. tricyclic antidepressants, cytochrome P450 Q Not recommended. inhibitors (esp. ketoconazole, paroxetine), CYP2D6 D Known QT-interval prolongation, inhibitors, quinidine, buspirone, fluoxetine, anticongenital long QT syndrome. Recent MI, convulsants, carbamazepine, phenobarbital, uncompensated HF. Pregnancy, lactation. B Bradycardia, electrolyte disturbances. If rifampicin, phenodione. A Agitation, insomnia, depression, cardiac symptoms occur, a cardiac evaluation psychotic disorder, extrapyramidal disorder, should be performed. Neuroleptic malignant hyperkinesia, headache, tardive dyskinesia, syndrome and torsade de pointes have been oculogyric crisis, dystonia, dyskinesia, akkathisia, reported rarely. Tardive extrapyramidal syndrome bradykinesia, hypokinesia, hypertonia, masked after long-term treatment, reduce dose or facies, somnolence, tremor, dizziness, visual discontinue. History of seizures, hepatic disturbance, orthostatic hypotension, hypotension, impairment. Patients with risk factors for stroke. GI disorders, abnormal liver function test, rash, Contains lactose. Ability to drive or operate urinary retention, erectile dysfunction, inj. site machinary my be impaired. Women of child reaction, increased/decreased weight. bearing potential should use contraception. C Contra: Class IA and III antiarrhythmics, INVEGA Janssen-Cilag arsenic trioxide, halofantrine, levomethadyl, mesoridazine, thioridazine, pimozide, sparfloxacin, 2 M O Other antipsychotics. Paliperidone 3mg, 6mg, 9mg. gatifloxacin, moxifloxacin, dolasetron mesylate, Trilayer cylindrical-shaped longitudinal prolongedmefloquine, sertindole, cisapride, drugs that release tabs. 3mg, white marked PAL 3; 6mg, prolong the QT interval. Caution: CNS drugs, beige marked PAL 6; 9mg, pink marked PAL 9. alcohol, ketoconazole, carbamazepine. 3mg-28, A125.92; 6mg-28, A132.36; 9mg-28, A Restlessness, dystonia, akathisia, A170.46. extrapyramidal disorder, parkinsonism, tremor, S Treatment of schizophrenia. dizziness, sedation, somnolence, headache, vision P 6mg once daily, in the morning. Range: blurred, GI disorders, musculoskeletal rigidity, 3-12mg once daily. Always take in fasting state or asthenia, fatigue. always take with breakfast and do not alternate the two. Adjust dose only after clinical HALDOL DECANOATE Janssen-Cilag between reassessment. Swallow tab. whole with liquids. 2NO Mild renal impairment: 3mg once daily; increase if Butyrophenone. Haloperidol (as decanoate) 50mg/ necessary. Moderate renal impairment: 3mg once ml, 100mg/ml. Slightly amber, slightly viscous oily daily. Severe renal impairment: 3mg every other sln for IM inj. in 1ml amps. 50mg/ml-5, A25.88; day, may increase to once daily after clinical 100mg/ml-5, A34.30. reassessment. S Long term management of behavioural Q Under 18 years, no experience. disorders, schizophrenia, hypomania and mania D Pregnancy (unless clearly necessary), and allied conditions. lactation. P Initially 50mg every 4 weeks by deep IM B Known CVD or family history of QT inj. May be increased to 200mg every 4 weeks in prolongation. Neuroleptic Malignant Syndrome/ 50mg increments. Higher doses may be given if tardive dyskinesia reported (discontinue). Monitor necessary. diabetics (and patients with risk factors). R Start with low doses 12.5-25mg every 4 Cerebrovascular disease, conditions that predispose to hypotension. History of seizures. Potential for weeks increasing according to response. GI obstruction; only use in patients who are able Q Not recommended. 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 impairment, dose adjustment may be required; due to alcohol or other depressant drugs. Clinically significant cardiac disorders, QTc interval ccQ10ml/min, not recommended. Severe hepatic prolongation, history of ventricular arrhythmia or impairment, not recommended. Elderly patients 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.
88
with dementia (particularly with risk factors for stroke). Parkinson’s disease, dementia with Lewy bodies. Risk of priapism (seek urgent medical care if not resolved within 3-4 hours). Conditions which may elevate core body temperature. An antiemetic effect may occur; which may mask overdosage/ other conditions. 3mg tab. contains lactose. C Not recommended: Risperidone. Caution: Drugs prolonging QT interval, other centrally acting drugs or alcohol, levodopa and other dopamine agonists, other agents that induce orthostatic hypotension or lower the seizure threshold or that affect GI transit time. Carbamazepine, rifampicin and St John’s wort (dose re-evaluation needed). 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. D Comatose states, phaeochromocytoma, marked cerebral atherosclerosis, renal or hepatic failure, severe cardiac insufficiency, severely depressed states, blood dyscrasias. B Caution: Liver disease, cardiac arrhythmias, CVD, family history of QTprolongation or narrow angle glaucoma, thyrotoxicosis, severe respiratory disease, epilepsy, Parkinson’s disease, elderly, hypothyroidism, myasthenia gravis, prostatic hypertrophy, very hot weather, surgery. Perform blood count and liver function tests (1st few months). Pregnancy, lactation. Driving/ using machines. C Avoid: Other antipsychotics, QT prolonging drugs and drugs causing elecrolyte imbalance. Large doses of hypnotics (contra). Caution: Alcohol, sedatives, strong analgesics, bblockers, thiazide diuretics, ACE-inhibitors, sympathomimetics, L-dopa, anti-convulsants, anticoagulants, MAOIs, TCAs, antidepressants, lithium, antidiabetics, corticosteroids, digoxin, neuromuscular blocking agents, anti-Parkinsonians, anticholinergics, quinidine and other antiarrythmics. A Parkinsonian-like states. Lethargy, blurred vision, dry mouth, nasal congestion, constipation, urinary disorders, mild hypotension, cognitive disorders, epileptiform attacks, rash, hypothermia, oedema.
NOZINAN
sanofi-aventis
2NO Phenothiazine group I. Levomepromazine (HCl)
2
5
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS
PSYCHOSES 3.3
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
89
3.3 PSYCHOSES
CNS
2.5%. Sln for inj. or inf. 10 x 1ml, A14.25. S Schizophrenia, other major psychoses incl. mania and hypomania. As adjunct in the relief of severe terminal pain with accompanying anxiety, restlessness or distress. P 12.5-25mg IM or IV after dilution, every 6 to 8 hrs. Severe cases, up to 50mg every 6 to 8 hrs. Alternatively 25-200mg daily, diluted with saline by continuous SC infusion. Q Not recommended. D Coma (particularly if associated with other CNS depressants). Closed angle glaucoma risk. Risk of urinary retention related to urethroprostatic disorders. History of agranulocytosis. Lactation. Pregnancy (only use if 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.
terfenadine, cisapride, bepridil, halofantrine and sparfloxacin; all contra. Drugs causing electrolyte disturbances (avoid). Caution: Anticholinergics, levodopa.
body dementia or Parkinson’s disease, epilepsy. Tardive dyskinesia may develop. Neuroleptic malignant syndrome may occur. Reduce/ discontinue if excitation, agitation and aggression occur. Elderly, hepatic and renal impairment. PERDAMEL Clonmel Elderly patients with dementia (weigh the risks against the benefits; avoid dehydration). Non 2NO drug-related hyperprolactinaemia, prolactinSelective monoaminergic antagonist. Risperidone dependent tumours. Diabetics and patients with 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red/ white/salmon/yellow/ light green or yellow film-ctd risk factors. Withdraw gradually. There is a lack of experience of preventative long-term treatment of tabs, resp. All marked R and strength. All (except 6mg) oblong and scored. 6mg, round, not scored. bipolar disorder. Contains lactose. Driving, using machines. 0.5mg-20, A8.36; 1mg-20, A10.86; 1mg-60, C Avoid: Alcohol. Caution: Centrally acting A32.55; 2mg-60, A64.23; 3mg-60, A94.44; 4mgdrugs, other antipsychotics, lithium, 60, A124.64; 6mg-30, A100.88. antidepressants, antiparkinson agents, drugs that S Schizophrenia. Maintenance treatment have a central anticholinergic effect, alphain order to prevent relapse in chronic blocking sympatholytics, methyldopa, reserpine, schizophrenia in responsive patients. Aggression centrally acting antihypertensive agents, and pronounced psychotic symptoms in patients guanethidine, levodopa and other dopaminergic with dementia in whom such disorders can cause agonists, carbamazepine. Potent CYP2D6 suffering, potential danger or risk of self-harm in inhibitors. Drugs prolonging QT-interval. Drugs the patient. Manic episodes in association with that may cause electrolyte disturbances. bipolar disorder. Serious acting out conduct Furosemide in elderly patients with dementia. disorders such as behavioural disorder and oppositional defiant disorder according to DSM IV A Agitation, anxiety, insomnia, headache, sedation, weight gain. in patients with psychological development disorders. Serious conduct disorders in children RESDAL Niche and adolescents with autism. 2NO P Swallow tabs with water. Acute and chronic treatment of schizophrenia: Taken once Selective monoaminergic antagonist. Risperidone daily or twice daily. Initially 2 mg/day. May be 0.5mg, 1mg, 2mg. Round, slightly convex, pink increased to 4mg/day on day 2. Usual range: 4mg- marbled orodispersible tablets. 0.5mg-28, A7.45; 6mg/day. Caution doses q 10mg daily. Max: 1mg-28, A16.03; 2mg-28, A32.11. 16mg/day. Serious conduct disorders: r50kg: S Treatment of schizophrenia. Initially 0.5mg daily; increase as required by 0.5mg Maintenance treatment in order to prevent daily every other day. Optimal dose: 1mg daily; relapse in chronic schizophrenia in responsive range 0.5mg-2mg once daily. Q50kg: Initially patients. 0.25mg daily. Dose can be increased as required P Initially 2mg daily; may increase dose to by 0.25mg daily every other day. Optimal dose: 4mg on day 2. Usual optimal dose: 4-6mg daily. 0.5mg daily; range 0.25mg-2mg once daily. Doses q10mg daily did not increase therapeutic Aggression and pronounced psychotic symptoms effect. Over 16mg, not recommended. If sedation in patients with dementia: Initially 0.25mg twice required benzodiazepine can be administered daily. Increase as required by 0.25mg twice daily concomitantly. Renal disorders: Initially 1 mg/day every other day. Optimal dose: 1mg daily. Some with slow titration to optimal dose (v adult doses). patients may need 2mg daily. When optimal dose Moderate to severe hepatic impairment: Caution. obtained, consider a once daily dose. Manic R Initially 0.5mg twice daily. Maintain or episodes in association with bipolar disorder: adjust individually with 0.5mg twice daily Initially 2mg once daily. May increase as required increments up to 1-2mg twice daily. by 1mg daily at 24 hour intervals. Optimal dose: 1- Q Over 15 years, as per adults. Under 15 6mg/day. Impaired renal function: Half starting years, not recommended. dose and titrate slower. D Pregnancy (unless benefits outweigh R Acute and chronic treatment of risk), lactation. ORAP Janssen-Cilag schizophrenia: Initially 0.5mg twice daily. May B Elderly patients with dementia: Avoid 2MO increase by 0.5mg twice daily to 1-2mg twice dehydration, increased risk of cerebrovascular daily. Manic episodes in association with bipolar events (assess risks against benefits). May cause Diphenylbutylpiperidine. Pimozide 4mg. Green disorder: Initially 0.5mg twice daily. Adjust orthostatic hypotension (consider dose reduction). scored tab. marked 0/4 one side, JANSSEN on individually to 1-2 mg twice daily. Possible induction of tardive dyskinesia. reverse. 100, A36.48. Q Acute and chronic treatment of Neuroleptic malignant syndrome may occur. S Management of schizophrenia and schizophrenia: Under 15 years, not recommended. Caution: Lewy body dementia, Parkinson’s disease, allied psychoses incl. monosymptomatic Serious conduct disorders: As per adults. Under 5 epilepsy, family history of QT prolongation, known hypochondriacal psychoses. years of age, limited data. Autism: Initially 0.25mg/ cardiovascular disease, non drug-related P Schizophrenia and allied psychoses: day for patients Q 30kg and 0.5mg/day for hyperprolactinaemia, prolactin-dependent Initially 2-4mg daily, maintenance 2-12mg daily patients r 30kg. Day 4, may increase as required tumours, diabetes (or at risk patients). Driving/ depending on individual response. Max. 20mg by 0.25mg for patients Q 30kg and 0.5mg for using machines. Contains: Phenylalanine daily. Elderly, half starting dose. patients r 30kg. Maintain dose and evaluate on (aspartame), sorbitol. Q Not recommended. C Avoid alcohol. Caution: Drugs acting on D Patients with pre-existing congenital QT day 14. Dosage can be increased at 2-weekly intervals by 0.25mg for patients Q 30 kg and 0.5 CNS including other antipsychotics, lithium, prolongation and patients with history of cardiac antidepressants, antiparkinson agents and active arrhythmias. mg for patients r 30 kg. Maximum dosage in substances with a central anticholinergic effect, B Endogenous depression. Parkinsonism, clinical studies did not exceed 1.5mg for patients levodopa and other dopaminergic agonists, epilepsy. Cardiovascular disorders. Pregnancy, Q 30 kg, 2.5 mg for patients r 30 kg or 3.5 mg carbamazepine or other hepatic enzyme inducing 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, drugs, phenothiazines, TCAs and certain bblockers, strong CYP2D6 inhibitors , cimetidine, quinidine), drugs prolonging QT interval eg. no data. ranitidine, drugs prolonging QT-interval or causing certain anti-arrhythmics, TCAs, maprotiline, D Pregnancy (unless essential), lactation. phenothiazines, sertindole, astemizole, B Caution: Cardiovascular disorders, Lewy electrolyte disturbances.
90
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 white, orange, yellow, green oblong film-ctd tabs. marked Ris/0.5, Ris/1, Ris/2, Ris/3 and Ris/4 resp. 6mg:Yellow, round film-ctd tab. marked Ris/6. RISPAL Pinewood 0.5mg-20, A9.53; 1mg-20, A12.39; 60, A37.13; 2mg-60, A73.26; 3mg-60, A107.73; 4mg-60, 2NO A142.19; 6mg-28, A115.08. Selective monoaminergic antagonist. Risperidone 2NO 0.5mg, 1mg, 2mg, 3mg. Resp. red-brown, white, peach, yellow round biconvex film-ctd tabs. 0.5, 1 ALSO RISPERDAL QUICKLET Risperidone 1mg, 2mg, 3mg, 4mg. 1mg, 2mg: Light coral, square A and 2mg scored. 0.5mg-20, 8.75; 1mg-60, biconvex tabs. marked R1, R2 resp. 3mg, 4mg: A34.08; 2mg-60, A67.24; 3mg-60, A98.90. Coral, round biconvex tabs. marked R3, R4 resp. S Schizophrenia and other psychoses: 1mg-28, A22.34; 2mg-28, A42.08; 3mg-28, Acute and chronic, in which positive and/or A73.72; 4mg-28, A94.95. negative symptoms are prominent; affective 2NO symptoms; maintenance in responsive patients. ALSO RISPERDAL LIQUID Risperidone 1mg/ml. Bipolar disorder: Short-term treatment of acute Liquid. 100ml plus pipette, A50.53. mania or mixed episodes, as monotherapy or in S Schizophrenia. Moderate to severe combination with lithium or valproate. Severe manic episodes associated with bipolar disorders. behavioural disturbances in: Patients with Short-term treatment (up to 6 weeks) of persistent dementia; adults/children with impaired social aggression in with moderate to severe Alzheimer’s functioning; children with autism/ developmental dementia unresponsive to non-pharmacological disorders. P Schizophrenia: Take once or twice daily. approaches and at risk or harm to self or others. Initially, 2mg/day; may be increased to 4mg/day on Short-term symptomatic treatment (up to 6 weeks) day 2. Usual range: 4-6mg/day. Caution with dose of persistent aggression in conduct disorder in children r 5 years with subaverage intellectual q10mg/day. Max. 16mg/day. 1st episode, may functioning or mental retardation diagnosed benefit from lower doses and slower titration. Renal and liver disease: 0.5mg twice daily; may be according to DSM-IV criteria, requiring pharmacologic treatment. adjusted with 0.5mg twice daily increments to 12mg twice daily. Bipolar mania: Once daily. Range P Schizophrenia: Take once or twice daily. Initially, 2mg/day; may be increased to 4mg/day on 2-6mg/day. Monotherapy, start 2mg; may be day 2. Usual range: 4-6mg/day. Caution with dose increased by increment of max 1mg per 24 hrs. q10mg/day. Max. 16mg/day. Some patients may Adjunctive therapy, start 2mg; may be increased benefit from lower doses and slower titration. by increment of max 2mg/day every other day. Dementia: Initially 0.25mg twice daily adjusted by Bipolar mania: Once daily. Range 2-6mg/day. increments of 0.25mg twice daily every other day Initally 2mg/day; may be increased by increment of max 1mg per 24 hrs. Dementia: Initially 0.25mg if needed. Optimum dose 0.5mg twice daily; may twice daily adjusted by increments of 0.25mg be increased up to 1mg twice daily. When target twice daily every other day if needed. Optimum dose is reached, a once daily dosing regimen can dose 0.5mg twice daily; may be increased up to be considered. Disruptive behaviour disorders: 1mg twice daily. Renal/hepatic impairment: Half r50kg, initially 0.5mg once daily, adjusted by increments of 0.5mg once daily every other day, if dose; slower dose titration. R Schizophrenia/bipolar mania: 0.5mg needed. Optimum dose 1mg once daily; range 0.5twice daily; may be adjusted with 0.5mg twice 1.5mg once daily. R50kg, initially 0.25mg once daily, adjusted by increments of 0.25mg once daily daily increments to 1-2mg twice daily. Q Schizophrenia: Under 18 years, not every other day, if needed. Optimum dose 0.5mg recommended. Disruptive behaviour disorders: once daily; range 0.25-0.75mg once daily. q50kg, initially 0.5mg once daily, adjusted by R Schizophrenia: 0.5mg twice daily; may increments of 0.5mg once daily every other day, if be adjusted with 0.5mg twice daily increments to needed. Optimum dose 1mg once daily; range 0.51-2mg twice daily. 1.5mg once daily. Q50kg, initially 0.25mg once Q Schizophrenia: Under 15 years, not recommended. Autism: 5 years and over, see SPC. daily, adjusted by increments of 0.25mg once daily every other day, if needed. Optimum dose 0.5mg Disruptive behaviour,: See adult dose; limited once daily; range 0.25-0.75mg once daily. experience under 5 years. 2NO D Pregnancy (unless benefit outweighs ALSO RISPERDAL CONSTA Risperidone 25mg, risk), lactation. B Renal, hepatic, CVD, epilepsy, dementia, 37.5mg, 50mg prolonged release. Susp. for inj. 25mg-1, A120.28; 37.5mg-1, A173.65; 50mg-1, elderly. May occur: Orthostatic hypotension, A226.86. tardive dyskinesia, extrapyramidal symptoms, S Maintenance treatment of neuroleptic malignant syndrome (discontinue), schizophrenia in patients stabilised with oral hyperglycaemia, possible weight gain. Contains antipsychotics. lactose. 0.5mg, 2mg and 3mg tabs contain sunset P 25mg every 2 weeks (alternate yellow. Driving/operating machinery. buttocks); consider 37.5mg if stabilised on more C Caution: CNS acting drugs, levodopa than 4mg/day oral. Consider increase after 4 and other dopamine agonists, carbamazepine or weeks. Max. 50mg every 2 weeks. Ensure prior other hepatic enzyme inducing drugs, CYP2D6 tolerability with oral risperidone. suppl. with oral inhibitors (e.g.fluoxetine, paroxetine), furosemide risperidone for first 3 weeks as appropriate. (patients with dementia). Hepatic and renal impairment, caution, 25mg A Insomnia, agitation, anxiety, headache, every 2 weeks if min 2mg oral tolerated following mild and transient sedation. titration. See SPC. R 25mg every 2 weeks plus oral cover as RISPERDAL Janssen-Cilag above. 2NO Q Under 18 years, not recommended. Selective monoaminergic antagonist. Risperidone D Pregnancy (unless essential), lactation. B Caution: Elderly, diabetics, 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Brownish-red, A Agitation, anxiety, insomnia, headache and sedation, weight gain.
PSYCHOSES 3.3 hyperprolactinaemia, seizures. Higher incidence of cerebrovascular adverse events. May occur: Orthostatic hypotension, tardive dyskinesia, neuroleptic malignant syndrome (esp. Parkinson’s disease, dementia with Lewy bodies), QT prolongation, priapism, disruption of body temperature regulation. Contains lactose and aspartame. C Antiarrhythmics class Ia and III, TCA, some antihistaminics, other antipsychotics, some antimalerials (chinice, mefloquine), medicines causing electrolyte imbalance, centrally acting drugs, levodopa, dopamine agonists, carbamazepine or other hepatic enzyme-inducing 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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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3.3 PSYCHOSES
CNS
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, 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.
RISPEVA
Teva
2NO Selective monoaminergic antagonist. Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg. Brownish-red, round tab. marked R on one side and with score line on the other (0.5mg). White (1mg), pale brown (2mg), yellow (3mg) or pale green (4mg) round, bevelled biconvex film-ctd tabs, scored and marked with RIS above the score line and strength under the score line on one side. 0.5mg-20, A8.59; 1mg-20, A11.15; 60, A33.42; 2mg-60, A65.94; 3mg-60, A96.98; 4mg-60, A127.98. S Treatment of schizophrenia; maintenance of improvement in patients who have shown initial response. Moderate to severe manic episodes in BD patients. P Schizophrenia: Take once or twice daily. Initially 2mg daily. May increase to 4mg on day 2. Usual optimal dose: 4-6mg daily. Caution with dose q10mg/day. Max. 16mg/day. Manic episodes: Initially 2mg once daily. Adjust dose if indicated at intervals of min. 24 hours. Recommended dose: 26mg daily. Daily dose q 6mg, no data. Hepatic/ renal impairment: Initially 0.5mg twice daily. Adjust individually with 0.5mg twice daily increments up to 1-2mg twice daily. R Both conditions: Initially 0.5mg twice daily. Maintain or adjust individually with 0.5mg twice daily increments up to 2mg twice daily. Q Schizophrenia: Under 15 years, not recommended. Manic episodes: Under 18 years, not recommended. D Pregnancy (unless benefit outweighs risk), lactation. B Elderly with dementia (avoid dehydration). Dementia patients with history of CVA, TIA, hypertension or diabetes (avoid). Can cause orthostatic hypotension (consider dose reduction). Tardive dyskinesia, neuroleptic malignant syndrome may occur. Caution: Hepatic/ renal impairment, elderly, lewy body dementia or Parkinson’s disease, epilepsy, diabetes, CVD, prolactin-dependent tumours. Contains lactose. Driving/ using machine. C Avoid alcohol. Caution: CNS acting drugs, other antipsychotics, lithium, antidepressants, anti-parkinsonian drugs, central anticholinergics, levodopa and other dopaminergic
92
agonists, carbamazepine or other hepatic enzyme inducing drugs, strong CYP2D6 inhibitors, cimetidine, ranitidine, drugs prolonging QTinterval or causing electrolyte disturbances. A Insomnia, agitation, anxiety, headache, sedation.
A Insomnia, agitation, anxiety, headache, sedation, weight increase.
SERDOLECT
Lundbeck
2NO
Limbic selective antipsychotic. Sertindole 4mg, 12mg, 16mg, 20mg. Oval biconvex tabs. marked S and strength. Yellow, beige, rose, pink resp. 4mg2NO 30, A35.13; 12mg-28, A92.99; 16mg-28, A106.95; Selective monoaminergic antagonist. Risperidone 20mg-28, A120.49. 0.5mg, 1mg, 2mg, 3mg, 4mg, 6mg. Red, white, S Schizophrenia in patients intolerant to pink, yellow, dark pink, yellow oblong scored at least one other antipsychotic. Do not use in (6mg, twice) film-ctd tabs. resp. 0.5mg-20, A8.37; emergency situations for urgent relief of 1mg-20, A10.84; 60, A32.48; 2mg-60, A64.10; symptoms. 3mg-60, A94.26; 4mg-60, A124.42; 6mg-28, P Initially, 4mg once daily; increase by A100.68. increments of 4mg after 4-5 days on each dose 2NO until optimal daily maintenance dose of 12-20mg 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. P Swallow tabs. with water. Schizophrenia: Pregnancy, lactation. B Monitor ECG before and during Take once or twice daily. Initially 2mg daily. May treatment (see SPC); discontinue if QTc prolonged increase to 4mg on day 2. Usual optimal dose: 4q 500msec. Tardive dyskinesia, Neuroleptic 6mg daily. Caution with dose q10mg/day. Max. Malignant Syndrome reported (discontinue). 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 diabetes, mild/moderate hepatic impairment hours. Recommended dose: 2-6mg daily. Daily (slower titration and lower maintenance dose). dose q 6mg, no data. Behavioural disturbances: Withdraw gradually. Contains lactose. Driving/ Patients Q 50kg: Initially 0.25mg once daily; can 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 (0.25-0.75mg) once daily. Patients r 50kg: Initially prolonging QT interval eg. class Ia and III 0.5mg once daily; can be increased by 0.5mg once antiarrhythmics, thioridazine, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, daily no sooner than every 2nd day. Usual cisapride, lithium. Caution: CYP2D6 inhibitors e.g. maintenance dose, 1mg (0. 5-1.5mg) once daily. fluoxetine, paroxetine, CYP3A inducers. Hepatic/renal impairment: Half starting/ A Rhinitis/nasal congestion, abnormal maintenance dose, slower titration. ejaculation, dizziness, dry mouth, postural R Schizophrenia and manic episodes: Initially 0.5mg twice daily. Adjust individually with hypotension, weight gain, peripheral oedema, 0.5mg twice daily increments to 1-2mg twice daily. dyspnoea, paraesthesia, prolonged QT interval. Red/white blood cells urine positive. Q Schizophrenia: Under 15 years, not recommended. Manic episodes: Under 18 years, SERENACE Teva not recommended. Behavioural disturbances: Under 5 years, not recommended. 2NO D Pregnancy (unless benefit outweighs CAPSULES. Butyrophenone. Haloperidol 0.5mg. risk), lactation. Soln: Hyperprolactinaemia (not Two-tone, green hard gelatine cap. marked drug induced). NORTON 500 on one half, Serenace on the other. B Elderly with dementia (avoid 30, A0.71. dehydration). Dementia patients with history of 2NO CVA, TIA, hypertension or diabetes. Can cause orthostatic hypotension (consider dose reduction). ALSO SERENACE TABLETS Haloperidol 1.5mg, Long term treatment: Tardive dyskinesia can occur. 5mg, 10mg, 20mg. White, bright pink, pale pink, dark pink, resp., biconvex tabs marked NORTON Neuroleptic malignant syndrome may occur. followed by strength resp. on one side and Caution: Hepatic/renal impairment, elderly, lewy SERENACE on reverse. 1.5mg-30, A1.22; 5mg-30, body dementia or Parkinson’s disease, epileptics, A2.27; 10mg-30, A4.58; 20mg-30, A13.32. diabetics, CVD or family history of QT 2 NO prolongation, prolactin-dependent tumours, ALSO SERENACE ORAL SOLUTION Haloperidol exposure to extremes of temperature. Psychoorganic disturbances, increased risk of undesirable 2mg/ml. 100ml, A7.35; 500ml, A36.76. S Schizophrenia, mania, hypomania, effects. Patients at risk for aspiration pneumonia. paranoid psychosis, agitation, psychotic illness, Tabs contain lactose. Driving/using machines. childhood behaviour disorders, severe motor tics, C Avoid alcohol, antipsychotics. Caution: Gilles de la Tourette syndrome, intractable hiccup, Centrally acting drugs, lithium, antidepressants, severe nausea/vomiting except hyperemesis anti-parkinsonian drugs, drugs with central gravidarum. Caps are also indicated as adjunct in anticholinergic effect, levodopa and other anxiety states. dopaminergic agonists, carbamazepine or other P Initially 1.5-20mg daily, increasing as hepatic enzyme inducing drugs, strong CYP2D6 required for control, then decreasing for inhibitors, diuretics, antacids, cimetidine, ranitidine, drugs prolonging QTc interval. maintenance, usually 3-10mg daily. Gilles de la
RISPONE
Rowex
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 Tourette: Initially 2mg daily increasing to 6-50mg followed by gradual reduction to maintenance around 4mg. R Half dose. Q Initially 0.025-0.05mg/kg daily to max. 10mg. Maintenance 0.05mg/kg. D Comatose states. Parkinson’s disease. Pregancy (unless essential). Lactation. Tabs: Clinically significant cardiac disorders, QTc prolongation, history of ventricular arrhythmia or Torsades de pointes. Uncorrected hypokalaemia. B Great Caution: Basal ganglial lesions, thyrotoxicosis. Hepatic/ renal dysfunction, epilepsy, 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 hypotension, history of seizures, patients at risk for aspiration pneumonia. Monitor diabetic patients. May increase metabolic risk. May occur: Tardive dyskinesia, neuroleptic Monitor for suicidal tendencies, esp. at beginning. Caution: Hepatic impairment, cardiovascular or cerebrovascular disease, hypotension, history of seizures, patients at risk for aspiration pneumonia. Monitor diabetic patients. May increase metabolic risk. May occur: Tardive dyskinesia, neuroleptic malignant syndrome, lipid changes. Driving/operating machines. Pregnancy (only if benefit outweighs risk), lactation (avoid). XR tab. contain lactose. 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
S Schizophrenia, psychosis, severe psychomotor agitation, dangerous impulsive behaviour. P Initially 5mg twice daily, increasing after 7 days to 15mg daily. If required increase further by 5mg at three-day intervals, then reduce to maintenance dose. See SPC. Up to 25mg. R Reduce by at least half. Q Up to 5mg daily in divided doses. See lit. D Comatose states, bone marrow depression, liver damage, existing blood dyscrasis. 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.
Sanofi 2 N O
2MO
Benzamide. Amisulpride 50mg, 100mg, 200mg, 400mg. White to off white, round, breakable tab. SEROQUEL XR AstraZeneca engraved AMI and strength on one side. 50mg-60, A20.09; 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. with XR and strength. 50mg-60, A63.08; 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,
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:
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
should be initiated as soon as clinically appropriate. P Starting dose, 10mg as a single IM inj. A second inj. may be admin. 2 hours after first inj. based on clinical status. Max. daily dose: 20mg with not more than 3 inj. in any 24-hour period. Max. duration: 3 consecutive days. Do not admin. by IV or SC inj. R 60 years and over, consider starting dose 2.5-5mg with a second injection of 2.5-5mg after 2 hours depending on patient clinical status. Q Under 18 years, not recommended. D Narrow angle glaucoma. Lactation. 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 ABILIFY BMS treatment. P Schizophrenia: Starting dose, 10mg as a 2 N O single daily dose. Bipolar Disorder: Manic episode, Atypical antipsychotic. Aripiprazole 5mg, 10mg, initially 15mg as single daily dose in monotherapy 15mg, 30mg. Rect. and blue, rect. and pink, round or 10mg daily in combination therapy. Prevention, and yellow, round and pink tabs., marked A-007 initially 10mg daily or same dose as prior and 5, A-008 and 10, A-009 and 15, A-011 and 30 treatment of manic episode. Continue olanzapine resp. 5mg-28, A123.79; 10mg-28, A128.41; 15mgin combination therapy as required if new manic/ 28, 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. experienced predominantly manic episodes and R 65 and over, consider starting dose 5mg 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. Q Under 15 years, not recommended. Over ALSO ZYPREXA 10MG INJECTION Olanzapine 15 years, schizophrenia: Initially 2mg for 2 days 10mg. Yellow lyophilised powder for soln. for IM titrated to 5mg for 2 additional days to reach inj. 1, A5.00. S Rapid control of agitation and disturbed recommended daily dose (10mg). May be behaviours in patients with schizophrenia or manic increased in 5mg increments to max 30mg daily. 2NO episode, when oral therapy is not appropriate ALSO ABILIFY ODT Aripiprazole 10mg, 15mg. (short term use). The use of oral olanzapine
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 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.
94
Orodispersible round tab. marked with strength on one side and A over 640 or 641 resp. on reverse. 10mg, pink; 15mg, yellow. 10mg-28, A141.12; 15mg-28, A141.12. S Schizophrenia. Treatment of 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.
2NO ALSO ABILIFY ORAL SOLUTION Aripiprazole 1mg/ 1ml. Bottle. 150 ml, A137.36 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, A18.48. 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
2
5
m
c
s
b
d
Permitted
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,
OCD
CNS
10mg. May be increased to max 40-60mg daily. Antidepressant effect not expected for at least 2 weeks. Treatment duration at least 4-6 months. ANAFRANIL Novartis Panic disorder: Single dose 10mg/day for 1st week. Dose may be increased to max 40-60mg/day. Max 2NO effect after 3 months. May need to be continued TCA. Clomipramine (HCl) 10mg orange/caramel for several months. Reduced hepatic function: cap. 25mg brownish orange/caramel cap. 50mg Initially 10mg/day. Max 30mg. light grey/caramel cap. All marked GEIGY. 10mgR Major depressive episodes: 10-20mg A A A 84, 3.46; 25mg-84, 6.92; 50mg-56, 8.64. daily. May be increased to max 30-40mg daily. S Depression incl. manic depression, Panic disorder: Initially 10mg once daily, after 1 obsessional and phobic states. Adjunctive week may be increased to 20mg daily. May be treatment of cataplexy. increased to max 40mg daily. P Depression: 10mg increasing gradually Q Not recommended. to 30-150mg daily individed doses or as a single B Should not be used under 18 years. dose at night; max. 250mg daily. Obsessional and Severe renal failure: Not recommended. Impaired phobic states: 25mg daily increasing gradually to 100-150mg daily. Cataplexy: 10mg daily increasing hepatic function: Reduce dose, monitor liver function. May occur: Initial anxiogenic effect when up to 50mg daily. starting therapy (reduced dose reduces risk), R Initially 10mg daily. Max. 75mg daily serotonin syndrome (discontinue), hyponatraemia, Q Not recommended syndrome of inappropriate anti-diuretic hormone 2NO secretion (elderly), may increase psychotic ALSO ANAFRANIL SR Clomipramine (HCl) 75mg. symptoms. Withdraw gradually. Pregnancy, Pink cap.-shaped sust.-release tab. Scored both lactation. Contains lactose. sides marked CG one side and GD on reverse. 28, C Contra: MAOI (or within 14 days), 5-HTA8.04. agonists. Caution: Lithium, metoprolol, S Depression; obsessional and phobic desipramine, dimetidine, St John’s Wort. states. Adjunctive treatment of cataplexy. A Headache, tremor, dizziness, migraine, P Depression: 10mg increasing gradually paraesthesia, palpitations, tachycardia, postural to 30-150mg daily in divided doses or as a single hypotension, hypotension and hypertension, GI dose at night; max. 250mg daily. Obsessional and disorders, micturition disorder, polyuria, weight phobic states: 25mg daily increasing gradually to decrease/increase, rhinitis, sinusitis, ejaculation 100-150mg daily. Cataplexy: 10mg daily increasing failure, female anorgasmia, dysmenorrhoea, up to 50mg daily. impotence, increased sweating, rash, pruritus, R Initially 10mg daily. Max. 75mg daily. abnormal accommodation, abnormalities of vision, Q Not recommended. taste abnormalities. D Pregnancy, lactation. Hypersensitivity to dibenzazepines,cardiac arrhythmias, mania, severe BELLSERT Ranbaxy liver disease, narrow angle glaucoma, urine 2MO retention. B Risk of suicide; monitor carefully. Other SSRI. Sertraline 50mg, 100mg. White film-ctd caplet-shaped tab. embossed with strength one psychiatric effects, cardiac and vascular disorders, side and break-line the other. 50mg-28, A20.57; epilepsy, pregnancy, hepatic disease and tumours 100mg-28, A30.69. of the adrenal medulla. Elderly, driving/using S Major depressive episodes. machinery. Contains lactose. P 50mg once daily with sufficient liquid. If C Contra: MAOIs (or within 3 weeks), required, may be increased to 100mg/day. adrenergic neurone blockers, anticholinergic Increments in steps of 50mg at minimum intervals drugs, CNS depressants, diuretics, MAOIs, SSRIs, of 1 week. Aim for lowest possible dosage with CYP2D6 inhibitors, neuroleptics, H2 receptor adequate therapeutic efficacy during long term antagonists, methylphenidate, CYP450 enzyme therapy. Impaired hepatic function: Reduce dose, inducers. prolong interval between doses. Antidepressant A Drowsiness, fatigue, restlessness, effect may start within 7 days, max effect after 2 increased appetite, confusion, disorientation, to 4 weeks (inform patient). May require long hallucinations, sleep disturbances, aggressiveness, term therapy to control remission (at least 6 aggravated depression, dizziness, tremor, headache, myoclonus, delerium, speech disorders, months). R Lowest possible dosage. muscle weakness, dry mouth, blurred vision, Q Under 18 years, not recommended. disturbances in micturition, hot flushes, mydriasis, B Monitor suicidality. Caution: History of tachycardia, postural hypotension, ECG changes, GI mania/hypomania, epilepsy (unstable epilepsy, disorders, elevated transaminases, skin rash, avoid use; controlled stable epilepsy, careful urticaria, pruritus, weight gain, disturbances of monitoring; discontinue if seizures occur), ECT, libido and potency, galactorrhea, breast diabetes (check blood glucose levels regularly; enlargement, taste disturbances, tinnitus. adjust insulin and/or hypoglycaemics) history of bleeding disorders, instable cardiac disease, BELLCITAL Ranbaxy 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. outweighs risk). Driving/operating machinery. debossed with strength on one side and the other 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), St John’s Wort. Caution: Drugs bound to plasma S Major depressive episodes. Panic proteins, diazepam, tolbutamide, cimetidine, disorder with or without agoraphobia. P Major depressive episodes: Single 20mg hypoglycaemics, anticoagulants, salicylic acid derivatives and NSAIDs, lithium, diuretics, daily oral dose. Can be increased gradually by 80mg. Q Under 18 years, not recommended.
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phenytoin, sumatriptan, antipyrine, changeover from other SSRIs or other antidepressants. Avoid alcohol. A GI disorders, dry mouth, increased sweating, tremor, dizziness, insomnia, somnolence, anorexia, sexual disorders, asthenia, tiredness, hot flushes, skin rash, chest pain, palpitations, tinnitus, headache, motor disorders (incl. hyperkinesia, increased musle tone, teeth grinding, impaired gait), paraesthesiae, hypaesthesia, yawning, agitation, anxiety, menstrual disorders, impaired vision.
BELLZAC
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 SSRI. Fluoxetine (HCl) 20mg. Olive/green cap. 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, A3.38. 0.5mg-100, A6.53. 1mg-100, A13.64. 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
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,
S Depressive illness treatment in the initial phase and as maintenance against potential relapse/recurrence. Panic disorder with or without agoraphobia. P Depression: Single 20mg daily oral dose. If necessary, may be increased to max 60mg daily. Treatment duration of at least 6 months usually necessary. Panic disorder: Single dose of 10mg daily the 1st week. May be increased to 20mg and up to 60mg daily max. Max effect reached after 3 months. May need to be continued for several months. Reduced hepatic function: Restrict dosage 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 28, A9.60; 20mg-28, A15.05; 40mg-28, A31.07. 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) rhinitis, micturition disorder, polyuria, ejaculation taken with fluid. Major depressive episodes: 20mg failure, female anorgasmia, fatigue. daily; max: 60mg daily. Continue 4-6 months after 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), A9.61 ; 20mg-28 (Cal/Pk), A15.06. 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, ALSO CIPRAMIL DROPS Citalopram (HCl) 40mg/ml cimetidine. A A Somnolence, insomnia, anxiety, suicide. (equiv. 20mg per 10 drops). 15ml, 29.72. P Depression, 16mg (8 drops) once daily Dizziness, tremor, headache, paraesthesia, mixed with water, orange or apple juice; panic palpitations, tension disorders. Nausea, dry mouth, disorder, 8mg for 1st week, increasing to 16mg GI disorders, sweating, rash, pruritus, abnormal daily. Increase if necessary to max. 48mg daily. accommodation, asthenia, polyuria, rhinitis, Reduced hepatic function: Max. 24mg daily. sinusitis, anorgasmia, impotence, dysmenorrhoea. R Max. 32mg daily. Q Under 18 years, not recommended. CIPRALAM Actavis 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. halves. 10mg-28, A9.04; 20mg-28, A14.16. C Contra: Pimozide, MAOIs (non-selective,
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. 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
selective A). Caution: Selegiline, 5HTagonists, st John’s Wort, lithium, tryptophan, drugs affecting platelet function, ECT, alcohol. A Nausea, sweating, diarrhoea, somnolence, insomnia, dry mouth. Decreased appetite, tremor, paraesthesia, agitation, anxiety, confusional state, libido decreased, abnormal orgasm, impotence, yawning, tinnitus, pruritus, myalgia, arthralgia, fatigue, weight decrease.
CIPRAPINE
Pinewood
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
97
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
C MAOIs (within 14 days); contraindicated. Alcohol, St John’s Wort, 5-HT agonists, tryptophan; not recommended. Caution: CYP2D6 substrates, cimetidine, lithium, desipramine, neuroleptics, anticoagulants and drugs increasing bleeding risk (e.g. NSAIDs, antipsychotics, TCAs). A Somnolence, insomnia, agitation, nervousness, headache, tremor, dizziness, palpitations, nausea, dry mouth, GI disorders, increased sweating, abnormal accommodation, CITALOPRAM TEVA Teva asthenia, tachycardia, hypotension, hypertension, micturition disorder, polyuria, weight change, 2NO rhinitis, sinusitis, sexual disorders, rash, vision or SSRI. Citalopram hydrobromide eq. to citalopram taste abnormalities. 40mg. White oval film-ctd tab. with break-line. 40mg-28, A27.10. CYMBALTA Lilly S Major depressive episodes. 2NO P Single 20mg daily oral dose. If necessary, can be increased up to 40mg daily; max. 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, 60mg daily. Effect not to be expected for at least 60mg. Opaque caps. White body marked 30mg 2 weeks. Continue until 4-6 months free of with blue cap marked 9543; green body marked symptoms. Mild/moderate hepatic impairment: 60mg with blue cap marked 9542 resp. 30mg-28, A 20.50; 60mg-28, A 34.15. Initially, 10mg daily for first 2 weeks; may be increased to 30mg daily. S Major depressive disorder. R 10-20mg (max. 40mg) daily. P Recommended dose, 60mg once daily. Q Under 18 years, not recommended. Response usually seen after 2-4 weeks. Max. B Severe renal impairment (avoid). May 120mg daily given in evenly divided doses. After occur: Akathisia, serotonin syndrome (discontinue), consolidation of response, continue treatment for hyponatraemia, bleeding abnormalities, psychotic several months. In responding patients with symptoms. Caution: Diabetes, controlled epilepsy history of repeated major depressive episodes, (discontinue if seizures develop), unstable epilepsy consider further long-term treatment with 60(avoid), history of mania/hypomania, ECT. Monitor 120mg/day. Discontinue gradually over 1-2 weeks. for clinical worsening and suicidal behaviour. Q Under 18 years, not recommended. Withdraw gradually over 1-2 weeks. Pregnancy (if D Liver disease resulting in hepatic clearly necessary), lactation. Contains lactose. impairment, severe renal impairment (ccQ30ml/ C Contra: MAOI (or within 14 days min), uncontrolled hypertension. Pregnancy (unless following their discontinuation). Avoid: essential), lactation. Serotonergics (e.g. tryptophan, triptans, 5HTP, B History of mania, bipolar disorder, tramadol), St John’s Wort, alcohol. Caution: QT seizures, increased IOP or risk of acute narrowinterval prolonging drugs, drugs lowering seizure angle glaucoma. Hypertensive crisis reported. threshold (e.g. antidepressants, neuroleptics, Hypertension, cardiac disease; monitor BP at least mefloquin, bupropion), drugs increasing risk of 1st month. Elderly. Suicidal thoughts; monitor haemorrhage (e.g. anticoagulants, NSAIDs, carefully. May occur: Liver injury, incl. severe acetylsalicylic acid, dipyridamol, ticlopidine, elevations of liver enzymes, hepatitis and jaundice. atypical antipsychotics, phenothiazines, TCAs). Akathisia may develop. Driving/using machines. A Somnolence, insomnia, agitation, Contains sucrose. headache, tremor, dizziness, paraesthesia, C Non-selective, irreversible MAOIs and impaired concentration, abnormal dreaming, potent CYP1A2 inhibitors, eg. fluvoxamine, amnesia, anxiety, increased appetite, anorexia, ciprofloxacin, or enoxacine (all contraindicated), apathy, confusion, palpitations, tachycardia, BP other MAOIs (not recommended). Caution: change, GI disorders, micturition disorder, Anticoagulants, St John’s wort, warfarin, CYP2D6 polyuria, weight change, rhinitis, sinusitis, substrates, other centrally acting and sedative dysmenorrhoea, sexual disorders, sweating, rash, drugs, smoking. pruritus, vision/taste disorders, asthenia. A Weight decrease, palpitations, tremor, paraesthesia, blurred vision, tinnitus, yawning, GI CITROL Rowex disorders, increased sweating, rash, musculoskeletal pain, muscle tightness, muscle spasm, 2NO decreased appetite, flushing, fatigue, abdominal SSRI. Citalopram (hydrobromide) 10mg, 20mg, 30mg. 10mg, round tab; 20mg and 30mg, oblong pain, erectile dysfunction, insomnia, agitation, biconvex tabs. with one sided score notch marked decreased libido, anxiety, abnormal orgasm, abnormal dreams. C20 and C30. All white film-ctd. 10mg-28, A9.61; 10mg-30, A11.08; 20mg-28, A15.05; 30mg-28, DEPREGER Gerard A28.00 2NO S Major depressive episodes. SSRI. Sertraline (as HCl) 50mg, 100mg. White, filmP Usual dose, 20mg daily increasing to ctd tab. with ST breakline 50 or 100 on one side max. 60mg daily. Effect after at least 2 weeks; and G on reverse. 50mg-28, A18.28; 100mg-28, continue until no symptom for 4-6 months. A31.57. R 10mg daily. Max. 30mg daily. Q Under 18 years, not recommended. S Depression (treatment and prevention B Risk of suicide until therapeutic effects of relapses). Treatment of obsessive-compulsive are achieved. Diabetes, unstable epilepsy, history disorder (OCD), panic attacks with/without of mania, bleeding disorders, hepatic or severe agoraphobia, post-traumatic stress disorder (PTSD). renal impairment. Driving/operating machines. P Depression, OCD: 50mg daily; max. ECT. Lactation, pregnancy (only if essential). 200mg daily. Panic attacks , PTSD: Initially 25mg Withdraw slowly. daily; increase to 50mg daily after 1 week; max. 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.
98
200mg daily. Increase in 50mg steps at min. 1 week intervals. Max. effect reached after 2-4 weeks. Q Under 6 years, not recommended. OCD: 13-17 years, initially 50mg daily. 6-12 years initially 25mg daily; increase to 50mg daily after 1 week. Max. 200mg daily. Major depressive episode, panic disorder, PTSD: Under 18 years, not recommended. D Severe hepatic impairment, unstable epilepsy. B Impaired hepatic function, controlled epilepsy, heart disease, risk of haemorrhage. Pregnancy, lactation (only if essential). Monitor renal function (elderly), suicide risk. Monitor weight/growth in children receiving long-term treatment. Withdraw gradually. C Contra: MAOIs, pimozide, alcohol. Caution: Serotonergics, lithium, St John’s wort, TCAs, anticoagulants, NSAIDs, tolbutamide, insuline, diazepam, cimetidine, CYP2D6 substrates, phenytoin. A GI disorders, dyspepsia, dry mouth, sweating, tremor, dizziness, insomnia, somnolence, anorexia, headache, motor disorders, anxiety, male sexual disorders, menstrual disorders, tiredness, hot flushes, rash, chest pain, palpitations, tinnitus, impaired vision. Hyperkinesias, tremor, urinary incontinence and fever in children.
DOTHEP
Gerard
2NO TCA. Dothiepin (HCl) 25mg. Red/brown cap. marked G DN 25. 100, A4.51. S Depression, anxiety associated with depression.
2NO ALSO DOTHEP TABLETS Dothiepin (HCl) 75mg. Red film-ctd tab. marked DN/75 one side and G on reverse. 28, A3.54; 100, A12.32. P 75-150mg daily in divided doses or as single dose in the evening. R Initially 50-75mg daily. Q Not recommended. D See SPC.
EDRONAX
Pfizer
2NO Selective NA reuptake inhibitor. Reboxetine 4mg. White round, convex, scored tab. marked P/U and 7671 60, A25.36. S For the acute treatment of depressive illness/major depression and for maintaining clinical improvement. P 4mg twice daily. Increase if necessary after 3-4 weeks to 10mg daily. Max. 12mg daily. Renal or hepatic impairment, initially 2mg twice daily. R Not recommended. Q Under 18 years, not recommended. D Pregnancy, lactation. B History of convulsive disorders or heart disease, urinary retention, prostatic hypertrophy, glaucoma, bipolar patients. Monitor for suicidality. C Not recommended: CYP3A4 inhibitors e.g. azole antifungal agents; macrolide antibiotics e.g. erythromycin or fluvoxamine. Avoid: MAOIs. Caution: Ergot derivatives. Other antidepressants, K+ losing diuretics; no data. A Insomnia, vertigo, tachycardia, palpitation, vasodilation, postural hypotension, eye disorders (abnormality of accommodation), dry mouth, constipation, loss of appetite, sweating UTIs and other urinary disorders, male sexual disorders, chills.
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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CYMBALTA* (DULOXETINE) REPUBLIC OF IRELAND ABBREVIATED PRESCRIBING INFORMATION Presentation Hard gastro-resistant capsules, 30mg or 60mg of duloxetine. Also contains sucrose. Uses Treatment of major depressive episodes. Treatment of generalised anxiety disorder. Treatment of diabetic peripheral neuropathic pain (DPNP) in adults. Dosage and Administration Major Depressive Episodes Starting and maintenance dose is 60mg once daily, with or without food. Dosages up to a maximum dose of 120mg per day, administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials. However, there is no clinical evidence suggesting that patients not responding to the initial recommended dose may benefit from dose up-titrations. Therapeutic response is usually seen after 2-4 weeks. After establishing response, it is recommended to continue treatment for several months, in order to avoid relapse. Generalised Anxiety Disorder The recommended starting dose in patients with generalised anxiety disorder is 30mg once daily, with or without food. In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients. In patients with co-morbid major depressive episodes, the starting and maintenance dose is 60mg once daily. Doses up to 120mg per day have been shown to be efficacious and have been evaluated from a safety perspective in clinical trials. In patients with insufficient response to 60mg, escalation up to 90mg or 120mg may therefore be considered. After consolidation of the response, it is recommended to continue treatment for several months, in order to avoid relapse. Abrupt discontinuation should be avoided. When stopping treatment with Cymbalta the dose should be gradually reduced over at least one to two weeks to reduce the risk of withdrawal reactions. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, continue decreasing the dose, but at a more gradual rate. Diabetic Peripheral Neuropathic Pain Starting and maintenance dose is 60mg daily, with or without food. The plasma concentration displays large inter-individual variability. Hence, some patients that respond insufficiently to 60mg may benefit from a higher dose. The medicinal response should be evaluated after 2 months treatment. Additional response after this time is unlikely. The therapeutic benefit should regularly be reassessed. Contra-indications Hypersensitivity to any of the components. Combination with MAOIs. Liver disease resulting in hepatic impairment. Use with potent inhibitors of CYP1A2, eg, fluvoxamine, ciprofloxacin, enoxacine. Severe renal impairment (creatinine clearance <30ml/min). Should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. Breast-feeding is not recommended. Initiation in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis. Precautions Do not use in children and adolescents under the age of 18. No dosage adjustment is recommended for elderly patients solely on the basis of age. However, as with any medicine, caution should be exercised. Data on the use of Cymbalta in elderly patients with generalised anxiety disorder are limited. Use with caution in patients with a history of mania, bipolar disorder, or seizures. Caution in patients with increased intra-ocular pressure or those at risk of acute narrow-angle glaucoma. Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients. In patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended as appropriate, especially during the first month of treatment. Use with caution in patients whose conditions could be compromised by an increased heart rate or by an increase in blood pressure. For patients who experience
a sustained increase in blood pressure while receiving duloxetine, consider either dose reduction or gradual discontinuation. Caution in patients taking anticoagulants or products known to affect platelet function, and those with bleeding tendencies. Hyponatraemia has been reported rarely, predominantly in the elderly. Caution is required in patients at increased risk for hyponatraemia, such as elderly, cirrhotic, or dehydrated patients, or patients treated with diuretics. Hyponatraemia may be due to a syndrome of inappropriate anti-diuretic hormone secretion (SIADH). It is general clinical experience that the risk of suicide may increase in the early stages of recovery from depression. Other psychiatric conditions for which Cymbalta is prescribed can also be associated with an increased risk of suicide-related events. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients, and in particular those at high risk, should accompany drug therapy, especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts, and unusual changes in behaviour, and to seek medical advice immediately if these symptoms present. Since treatment may be associated with sedation and dizziness, patients should be cautioned about their ability to drive a car or operate hazardous machinery. Cases of akathisia/psychomotor restlessness have been reported for duloxetine. In patients who develop these symptoms, increasing the dose may be detrimental. Duloxetine is used under different trademarks in several indications (major depressive episodes, generalised anxiety disorder, stress urinary incontinence, and diabetic neuropathic pain). The use of more than one of these products concomitantly should be avoided. Cases of liver injury, including severe elevations of liver enzymes (>10-times upper limit of normal), hepatitis, and jaundice have been reported with duloxetine. Most of them occurred during the first months of treatment. Duloxetine should be used with caution in patients with substantial alcohol use or with other drugs associated with hepatic injury. Interactions Caution is advised when taken in combination with other centrally acting medicinal products and substances, including alcohol and sedative medicinal products; exercise caution when using in combination with antidepressants. In rare cases, serotonin syndrome has been reported in patients using SSRIs concomitantly with serotonergic products. Caution is advisable if duloxetine is used concomitantly with serotonergic antidepressants like SSRIs, tricyclics, St John’s Wort, venlafaxine, or triptans, tramadol, pethidine, and tryptophan. Undesirable effects may be more common during use with herbal preparations containing St John’s Wort. Effects on other drugs: Caution is advised if co-administered with products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone, and metoprolol). Anticoagulants and antiplatelet agents: Caution should be exercised when duloxetine is combined with oral anticoagulants or antiplatelet agents due to a potential increased risk of bleeding. Increases in INR values have been reported when duloxetine was co-administered with warfarin. Undesirable Effects The majority of common adverse reactions were mild to moderate, usually starting early in therapy, and most tended to subside as therapy
continued. Those observed from spontaneous reporting and in placebo-controlled clinical trials in depression, generalised anxiety disorder, diabetic neuropathic pain, and fibromyalgia at a rate of q1/100, or where the event is clinically relevant, are: Very common (q1/10): Nausea, headache, dry mouth, somnolence, fatigue, insomnia, dizziness, and constipation. Common (q1/100 and 1/10): Weight decrease, palpitations, tremor, paraesthesia, dysgeusia, lethargy, blurred vision, tinnitus, yawning, diarrhoea, vomiting, dyspepsia, flatulence, sweating increased, rash, night sweats, musculoskeletal pain, muscle tightness, muscle spasm, decreased appetite, flushing, abdominal pain, chills, erectile dysfunction, agitation, libido decreased, anxiety, orgasm abnormal, abnormal dreams, sleep disorder. Clinical trial and spontaneous reports of anaphylactic reaction, hyperglycaemia (reported especially in diabetic patients), mania, hyponatraemia, SIADH, hallucinations, dyskinesia, serotonin syndrome, extra-pyramidal symptoms, convulsions, akathisia, psychomotor restlessness, glaucoma, mydriasis, syncope, tachycardia, supra-ventricular arrhythmia (mainly atrial fibrillation), syncope, hypertension, hypertensive crisis, epistaxis, gastritis, haematochezia, dysuria, gastro-intestinal haemorrhage, hepatic failure, hepatitis, acute liver injury, angioneurotic oedema, Stevens-Johnson syndrome, trismus, and gynaecological haemorrhage have been made. Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation. Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation. Discontinuation of duloxetine (particularly abrupt) commonly leads to withdrawal symptoms. Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), fatigue, agitation or anxiety, nausea and/or vomiting, tremor, headache, irritability, diarrhoea, hyperhydrosis, and vertigo are the most commonly reported reactions. The heart rate-corrected QT interval in duloxetine-treated patients did not differ from that seen in placebo-treated patients. No clinically significant differences were observed for QT, PR, QRS, or QTcB measurements between duloxetine-treated and placebo-treated patients. In clinical trials in patients with DPNP, small but statistically significant increases in fasting blood glucose were observed in duloxetine-treated patients compared to placebo at 12 weeks. At 52 weeks there was a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients compared with a slight decrease in the routine care group. There was also an increase in HbA1c in both groups, but the mean increase was 0.3% greater in the duloxetine-treated group. For full details of these and other side-effects, please see the Summary of Product Characteristics, which is available at http://www.medicines.ie/. Overdose Cases of overdoses, alone or in combination with other drugs, with duloxetine doses of 4800mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with duloxetine alone at a dose of approximately 1000mg. Legal Category POM. Marketing Authorisation Numbers and Holder EU/1/04/296/001 EU/1/04/296/002 EU/1/04/296/003 EU/1/04/296/004 Eli Lilly Nederland BV Grootslag 1-5 NL-3991 RA Houten The Netherlands. Date of Preparation or Last Review July 2008. Full Prescribing Information is Available From Eli Lilly and Company Limited Lilly House, Priestley Road Basingstoke, Hampshire, RG24 9NL Telephone: Basingstoke (01256) 315 999 or Eli Lilly and Company (Ireland) Limited Hyde House, 65 Adelaide Road Dublin 2, Republic of Ireland Telephone: Dublin (01) 661 4377. *CYMBALTA (duloxetine) is a trademark of Eli Lilly and Company. Date of preparation January 2009. Reference: 1. Zimmerman M, McGlinchey JB, et al. Am J Psychiatry 2006;163:148-150. IECYB00004
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
related), porphyria. B Risk of severe liver damage (incl. hepatic failure); increased risk in children Q 3 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) years. Liver function tests advised before therapy 75mg, 150mg. Resp., flesh opaque/flesh opaque or and in first 6 months, especially when risk or scarlet opaque/scarlet opaque, size 0 or size 00 history of liver disease. Pancreatitis may occur, esp. hard gelatine cap. containing 2 or 3 white round, in young children (prompt medical evaluation in biconvex film-ctd tabs. 75mg-28, A22.15; 150mgpatients with acute abdominal pain). 28, A37.35. Monotherapy recommended in children Q 3 years S Treatment of depressive illness, incl. at risk of liver toxicity and pancreatitis. Blood cell depression accompanied by anxiety. Following count, bleeding time and coagulation tests advised initial response, for the prevention of relapses of before therapy. Monitor for suicidal thoughts/ the initial episode of depression or for the behaviour. Caution: Systemic lupus erythematosus. prevention of the recurrence of new episodes. Pregnancy (careful evaluation benefit/risk). Warn P Swallow whole with food. 75mg once patients about risk of weight gain. May cause daily for initiation and maintenance. If further false positives in urine tests for diabetes. clinical improvement required after 2 weeks, may Hyperammonaemia: Metabolic tests advised before be increased to 150mg once daily. If needed, can therapy in those at risk. Withdraw carefully. be further increased up to 225mg once daily. C Avoid salicylates in children Q 3 years. Increase doses at intervals of 2 weeks or more but Caution: Antipsychotics, MAOIs, antidepressants, no less than 4 days. Discontinue if no evidence of benzodiazepines, phenobarbital, primidone, clinical response after 8 weeks. Mild-moderate phenytoin, carbamazepine, lamotrigine, hepatic impairment: Reduce dose by 50%; further zidovudine, vit K-dependent anticoagulants, reduction may be required in some patients. felbamate, mefloquine, chloroquine, highly Moderate renal impairment: Reduce dose by 50%. protein Avoid salicylates in children Q 3 years. R Caution, use lowest effective dose. Caution: Antipsychotics, MAOIs, antidepressants, Q Under 18 years, not recommended. benzodiazepines, phenobarbital, primidone, B For prescribing information, see phenytoin, carbamazepine, lamotrigine, venlafaxine Drug Presc. Notes. 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 FAVERIN Solvay increased to max. 375mg/day. May be increased at 2NO 2 weeks interval to max 375mg/day. If clinically SSRI. Fluvoxamine maleate 50mg round white warranted, reduce interval (minimum 4 days). Severe renal impairment: 1/2 dose. Mild-moderate film-ctd scored tab. marked S and 291. 100mg white oval film-ctd scored tab. marked S and 313. hepatic impairment: 1/2 dose; further reduction 50mg-60, A28.99; 100mg-30, A28.99. may be required in some patients. S Treatment of symptoms of depressive R Use lowest effective dose. illness. Obsessive compulsive disorder. Q Under 18 years, not recommended. P Depression: Initially 50-100mg in the B For prescribing information, see evening. Usual maintenance 100mg daily. Max venlafaxine Drug Presc. Notes. 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, 4-7 days till effective dose reached. Max. 200mg. 300mg, 500mg. Violet oblong, film-ctd prolonged 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, or renal insufficiency. History of epilepsy. 500mg, 750mg, 1000mg. Prolong. release granules Pregnancy, lactation. in sachets. 100mg-30, A9.79; 250mg-30, A10.02; C Contra: MAOIs. Caution: TCAs, 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, neuroleptics, tacrine, theophylline, methadone, A18.72. mexiletine, warfarin, thioridazine, propranolol, caffeine, ropinirole, phenytoin, terfenadine, S Treatment and prevention of mania astemizole, cisapride, carbamazepine, ciclosporin, associated with bipolar disorders. benzodiazepines, triptans, St. Johnâ&#x20AC;&#x2122;s Wort, lithium, P Initially 20mg/kg/day. Usual alcohol. maintenance: 1-2g/day. Max 3g daily. Q Chronosphere, see adults. Epilim Chrono A Nausea, vomiting, asthenia, headache, malaise, palpitations, abdominal pain, anorexia, not suitable for children under 20kg. constipation, diarrhoea, dry mouth, dyspepsia, D Active liver disease, personal or family agitation, anxiety, dizziness, insomnia, history of severe hepatic dysfunction (esp. drug
EFAXIL XL
Pinewood
2MO
100
nervousness, somnolence, tremor, sweating.
FLUANXOL
Lundbeck
2MO Thioxanthene. Flupenthixol (diHCl) 0.5mg, 1mg. Round, biconvex, yellow, sugar-ctd tab. 0.5mg-60, A4.09; 1mg-60, A8.31. S Short-term management of mild to moderate depression with or without anxiety. P 1mg daily as a single dose in the morning. May be increased after 1 week to 2mg 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
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,
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 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 reported rarely. Tardive extrapyramidal syndrome olanzapine, quetiapine, praziquantel, caspofungin, 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 unresponsive or with contraindications to lithium IREVEN Teva therapy. P Initially 100-400mg, increased gradually 2 N O until symptoms controlled or to a total of 800mg. 5HT/NA reuptake inhibitor. Venlafaxine (HCl) 75mg, 150mg. Resp. flesh and scarlet opaque hard Exceptionally, max 1600mg in divided doses. gelatine prolonged-release caps containing two Maintenance: 400-600mg daily in divided doses. and three round, biconvex film-ctd tabs marked D Bone marrow depression, AV
demonstrated. Elderly. Driving/using machines. C MAOIs (or within 2 weeks). Sympathomimetics, adrenergic neuron blockers, CNS depressants, anticholinergics, quinidine, digitalis glycosides, cimetidine, clonidine, thyroid hormone therapy. A Hypotension, tachycardia, cardiac arrhythmias, dizziness, sleep disturbances, agitation, confusion, headache, dry mouth, constipation, sweating, accommodation disturbances, urinary hesitancy, urinary retention, sweating, tremor, induction of glaucoma, testicular disorders, skin rash, nausea, vomiting.
OCD
3.4
VEN on cap and strength on body. 75mg-28, A20.23; 150mg-28, A34.68. S Major depressive episodes. P Swallow whole with liquid once daily same time each day during meal. Initially, 75mg. May be increased to 150mg, then to 225mg. Patients not responding, doses up to 375mg (limited experience). Increase doses at intervals of 2 weeks or more with min. 4 days between each increment. If no response after 2-4 weeks, no benefit to be gained from treatment. Duration 4-6 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. A Headache, agitation, somnolence, dizziness, dry mouth, skin rash, arthralgia, pain, back pain.
LAMORO
Pinewood
2MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
101
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. Dispersible white to off-white round tabs. 25mg60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; 200mg-60, A96.11. S Prevention of mood episodes in patients with bipolar disorder (BP), predominantly by preventing depressive episodes. P Monotherapy or add on therapy to drugs with no interaction with lamotrigine e.g. lithium: Initially 25mg once daily for 2 weeks, followed by 50mg once daily or 2 divided doses 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.
OCD
CNS
in 2 divided doses daily for 2 weeks, then 200mg/ day for 1 week; thereafter increasing by 100mg per week up to target maintenance dose of 400mg/day in 2 divided doses. See SPC for dosing during withdrawal or addition of concomitant psychotropic drugs. Special patient populations: See SPC. Q Not recommended. B Renal failure (caution). Rare skin reactions eg. Stevens Johnson syndrome. Promptly evaluate patients who develop rash. 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.
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 Depression: Usually 10mg once daily, may be increased to max. 20mg daily. After 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. tryptophan, St. John’s Wort, drugs lowering S Prevention of mood episodes in patients 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 with breakline. 50mg-28, A21.00; 100mgLAMOTRIGINE RANBAXY Ranbaxy from week 7). See SPC for dose escalation in all edged 28, A31.55. cases. See SPC for dosing of lamotrigine during 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 A taken with sufficient liquid. Reduce gradually to 200mg-56, 66.51. reactions eg. Stevens Johnson syndrome. Promptly 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 B Hepatic impairment, controlled epilepsy, P Monotherapy or adjunctive therapy (AEDs) (eg. phenytoin, primidone, carbamazepine, 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: Initially 12.5mg )or 25mg on alternate days) for 2 lactation (only if benefit outweighs risk). Driving/ weeks, followed by 25mg once daily for 2 weeks; using machines. then 50mg/day (once daily or in 2 divided doses); C Contra: MAOIs (14 days apart), thereafter 100mg daily, once daily or in 2 divided pimozide. Avoid St John’s wort, serotonergics (eg. doses, may be increased up to 200mg max. trypthophan, fenfluramine, 5-HT agonists), Lundbeck Adjunctive therapy with enzyme inducers: Initially LEXAPRO alcohol. Caution: Cimetidine, diazepam, 2NO 50mg once daily for 2 weeks, followed by 100mg tolbutamide, hypoglycaemics, oral anticoagulants,
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
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
OCD
CNS
concomitant schizophrenia. Pregnancy and lactation, unless benefits outway risks. B Depressive patients with excitation, suicidal tendencies, epilepsy. Thyrotoxicosis or phaeochromocytoma. See SPC. C Ibuprofen, opiates, cimetidine. Coadmin. with 5-HT re-uptake inhibitors or precursors not recommended. A Sleep disturbances, dizziness, nausea, headache have occasionally been observed. In very rare cases confusional states have been reported. Some anti-cholinergic-like effects have been reported.
P Initially, 15-30mg dissolved on the tongue once daily at bedtime. Maintenance,1545mg per day. May be taken twice daily, with larger dose in the evening. Treatment duration, 46 months. Withdraw gradually if no effect with max. dose after 2-4 weeks. Q Under 18 years, not recommended. D Pregnancy (unless clearly indicated), lactation. B Monitor for bone marrow depression (discontinue if occurs). Suicide-related behaviours reported in children and adolescents. Caution with: Epilepsy and organic brain syndrome, hepatic or LUSTRAL Pfizer renal failure, heart disease, hypotension, MIRAP Rowex micturition disturbances, acute narrow-angle 2NO glaucoma and raised intra-ocular pressure, GI 2NO 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 A21.05. 100mg-28, A31.58. 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, A21.32; 45mg-30, A31.98. with or without agoraphobia. Social anxiety MIRTAZAPINE TEVA Teva disorder (SAD). Post-traumatic stress disorders S Major depressive episodes. 2NO (PTSD). P Initially, 15-30mg preferably in the Presynaptic a2-antagonist. Mirtazapine 15mg, P OCD/Depression: 50mg once daily. Panic evening. Maintenance,15-45mg per day. Renal or disorder/SAD/PTSD: Initially, 25mg daily increasing hepatic insufficiency: Also consider divided dose in 30mg, 45mg. Round, white, bevelled edge tab. marked 93 one side and 7303, 7304 or 7305, resp. to 50mg daily after 1 week. All indications: Dose 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; 45mg-30, A29.51. effect with max. dose after 2-4 weeks. Take tabs period of weeks, to max. 200mg daily. with sufficient water; orodisp. tabs with or S Major depressive episode. Q OCD: Age 13-17 years, 50mg/day; 6-12 without water. P Initially, 15mg or 30mg, in the evening. years, initially 25mg/day, increasing to 50mg/day Maintenance dose 15mg-45mg per day. after 1 week. Patients not responding, increase by R Changes in dosage under close supervision. Q Under 18 years, not recommended. 50mg/day increments at 1 week intervals; max. Q Under 18 years, not recommended. D Lactation, pregnancy (unless clearly 200mg/day. Under 6 years: Not recommended D Pregnancy (unless clearly indicated), indicated). D Significant hepatic insufficiency. lactation. B Monitor for signs of bone marrow Pregnancy, lactation. Unstable epilepsy or B Monitor patients with history of suicide- depression (discontinue if occurs). Suicide-related convulsant disorders. related events or exhibiting a significant degree of behaviours and hostility more frequently reported B Monitor for suicidality during 1st few suicidal ideation. Monitor for bone marrow in children and adolescents; monitor patients with weeks of treatment. Discontinue if patient enters depression; discontinue if fever, sore throat, history of suicide-related events, or exhibiting a manic phase. Controlled epilepsy. ECT, not stomatitis or other signs of infections occur. suicidal ideation prior to commencement. Caution: recommended. Monitor children for suicidality if Caution: epilepsy and organic brain syndrome, Epilepsy and organic brain syndrome, hepatic or treating for OCD. Driving or using machines. hepatic and renal impairment, cardiac diseases renal failure, heart disease, hypotension, GI C Contraindicated: MAOIs (or within 14 (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 diabetes, elderly. May occur: Exacerbation of Johnâ&#x20AC;&#x2122;s wort, diazepam, tolbutamide, cimetidine, pressure, diabetes mellitus, elderly, history of psychotic symptoms, switch to manic phase of TCAs, other centrally acting drugs, other mania/hypomania (discontinue if patient enters a bipolar disorder (discontinue). Withdrawal serotonergic drugs. manic phase). May worsen psychotic symptoms in symptoms may occur following abrupt A Anorexia, insomnia, dizziness, patients with schizophrenia or other psychotic termination. Discontinue if jaundice occurs. somnolence, tremor, GI disorders, increased sweating, ejaculatory delay. Also reported in OCD disorders. Discontinue if jaundice occurs. Withdraw Contains aspartame. Driving/operating machines. gradually. Driving/using machines. Tabs contain C Contra: MAOIs (or within two weeks). patients aged 6-17 years: Chest pain, fever, Caution: Benzodiazepines and other sedatives, malaise, hyperkinesia, urinary incontinence, other lactose. Orodisp. tabs contain aspartame and sulphites. other serotonergic drugs (e.g. SSRIs), potent psychiatric disorders, breast pain, dysmenorrhea, C Contra: MAOIs (or within 2 weeks after CYP3A4 inhibitors, HIV protease inhibitors, azole menstrual disorder, epistaxis, skin disorder, discontinuation). Avoid alcohol. Caution: antifungals, erythromycin or nefazodone, CYP3A4 headache, hyperkinesia. 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. A19.19; 45mg-30, A32.14. marked M2. 30, A22.52. Q Not recommended. D Acute confusional states. Patients with S Episode of major depression. S Major depressive episodes.
drugs affecting platelet function (e.g. NSAIDs, most TCAs), lithium, diuretics, phenytoin, sumatriptan, CYP2D6 substrates, warfarin, phenozone (antipyrine), changeover from other antidepressants. A GI disorders, dry mouth, dyspepsia, tremor, dizziness, insomnia, somnolence, anorexia, male sexual disorders, tiredness, hot flushes, skin rash, increased sweating, chest pain, palpitations, tinnitus, headache, asthenia, motor disorders, paraesthesia, hypoaesthesia, anxiety, yawning, agitation, menstrual disorders, impaired vision.
104
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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,
OCD
3.4
post-traumatic disorders: 20mg once daily in the morning with food; may be increased gradually in 10mg increments to max. 50mg once daily. OCD and panic disorder: Initially 20mg once daily (OCD) or 10mg daily (panic disorder); increase weekly in PARNATE Goldshield 10mg increments to 40mg daily; max. 60mg daily. R Max. 40mg daily. 2NO Q Under 18 years, not recommended. MAOI. Tranylcypromine (as sulph.) 10mg red sugD Children Q18 years with major A ctd tab. marked FW 251. 28, 14.79. depressive episodes. S Depression. B Hepatic/severe renal impairment, cardiac P Initially 1 twice daily, increasing if condition, increased risk of bleeding, history of necessary after one week to 1 three times daily. mania, epilepsy, ECT, narrow angle glaucoma, Maintenance, usually 1 daily. diabetes; caution. Serotonin syndrome, akathisia, Q Not recommended. hyponatraemia may develop. High risk of suicidal D See SPC. 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, thioridazine, tryptophan. Caution: St John’s Wort, film-ctd tabs. engraved 20 with a breakline on one SSRIs, tramadol, other serotonergics, CYP2D6 side. 30, A15.00. substrates (eg. phenothiazine neuroleptics, certain S Major depressive episode, obsessive TCAs, risperidone, certain 1c antiarrhythmics, compulsive disorder (OCD), panic disorder with or metoprolol), alcohol, anticoagulants, NSAIDs, without agoraphobia, Social Anxiety Disorders lithium, procyclidine. (SAD)/social phobia, Generalised Anxiety Disorder A Sexual dysfunction, nausea, decreased MOLIPAXIN sanofi-aventis (GAD). appetite, body weight gain, asthenia, somnolence, P Once daily in the morning with food. yawning, insomnia, dizziness, tremor, blurred 2MO Depression, SAD/social phobia, GAD: vision, GI disorders, sweating. Triazolopyridine. Trazodone (HCl) 150mg. Pink Recommended dose 20mg daily; max. 50mg/day. film-ctd scored tab. marked Molipaxin 150. 28, OCD: 40mg daily. Initially 20mg daily; max. 60mg/ PRIADEL Sanofi A11.88. day. Panic disorder: 40mg daily. Initially 10mg 2NO 2MO daily; max. 60mg/day. All doses should be Lithium salt. Lithium carbonate 200mg, 400mg. ALSO MOLIPAXIN CAPSULES Trazodone (HCl) increased if necessary in 10mg increments. 50mg, 100mg. Violet/green and violet/fawn cap. Duration several months or longer for OCD, panic Prolonged release tabs. marked P200 and PRIADEL resp. Both white scored tabs. 200mg-100, A2.96; coded R365B and R365C resp. 50mg-84, A17.71; disorder; at least six months for depression. 400mg-100, A4.36. 100mg-56, A20.85. R Max. 40mg/day. S Acute manic or hypomanic episodes, S Depression with or without anxiety. Q Under 18 years, not recommended. depressive disorders where other antidepressants P Initially 75-150mg daily as single D Pregnancy, lactation (unless absolutely 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. depression, increase to max. 600mg daily in min), hepatic impairment. Increase of suicidal P Initially 400-1200mg daily as a single divided doses. related behaviours. History of mania, cardiac dose. Maintain blood lithium levels in range 0.7R Initially 100mg daily in divided doses conditions, diabetes, epilepsy, increased risk of 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. Associated with akathisia, Serotonin Syndrome/ Q Under 18 years. not recommended. Neuroleptic Malignant Syndrome. Contains lactose. O D Pregnancy, lactation. ALSO PRIADEL LIQUID Lithium citrate 520mg Discontinue gradually. Driving / using machines. B Suicide and suicidal ideation. Epilepsy. C MAOIs, thioridazine, pimozide (contra), (equiv. to 5.4mmol Li+) per 5ml. Sugar free liquid. Severe hepatic, renal or cardiac disease. May metoprolol, alcohol (avoid). Caution: Serotonergic 150ml, A7.81. provoke bradycardia and hypotension. P Initially 10-30ml daily in two divided Agranulocytosis, thrombocytopenia and anaemia. drugs, lithium, drug metabolising enzyme doses. Maintain serum lithium levels in range 0.5inhibitors, procyclidine, anticonvulsants, CYP2D6 Alterations in liver function. Contains lactose. 0.8 mmol/litre 12 hours after previous dose. See substrates (eg. certain TCAs, phenothiazine Fructose intolerance, glucose-galactose SPC. neuroleptics, risperidone, certain Type lc malabsorption or sucrase isomaltase insufficiency. Q Not recommended. antiarrhythmics), NSAIDs, drugs increasing Driving/operating machinery. D Cardiac failure. Renal impairment. bleeding risk. C MAOIs, ketoconazole, ritonavir, Addison’s disease. Untreated hypothyroidism. A Decrease appetite, somnolence, indinavir, carbamazepine, muscle relaxants, Pregnancy, lactation. insomnia, agitation, dizziness, tremor, blurred volatile anaesthetics, alcohol, sedatives, B Monitor renal, cardiac, thyroid function vision, yawning, GI disorders, sweating, sexual antidepressants, clonidine, antihypertensives, prior to treatment and periodically during. Elderly dysfunction, asthenia, body weight gain. hypericum perforatum, digoxin, phenytoin. (caution). Check for signs of toxicity and advise Preparations containing St. John’s Wort. PAROX Rowex patients about symptoms. Maintain salt and fluid A Suicidal ideation/behaviour, dizziness, intake. Advise patients to report polyuria, headache, weakness, decreased alertness, weight 2NO polydipsia nausea, vomiting, diarrhoea, excessive loss, tremor, dry mouth, tachycardia, oedema, GI SSRI. Paroxetine (HCl) 20mg, 30mg. White and sweating and/or other conditions leading to salt/ disorders, rash, blurred vision, restlessness, blue tabs. marked 20 and 30 resp. Both oval water depletion. Contains Na+. confused states, insomnia, skin rash. biconvex film-ctd with a breakline. 20mg-30, C Thiazide diuretics, steroids, NSAIDs, ACE A15.00; 30mg-30, A22.53. inhibitors, metronidazole, methyldopa, NORZAC Teva S Major depressive episode, obsessive tetracyclines, osmotic diuretics, carbonic anhydrase 2NO compulsive disorder (OCD), panic disorder with or inhibitors, xanthine, Na+ bicarbonate, Ca++ channel SSRI. Fluoxetine (HCl) 20mg. Light green cap. 30, without agoraphobia, social anxiety disorders blockers, psychotropic/neuroleptic drugs, A13.53. (SAD)/social phobia, generalised anxiety disorder carbamazepine, triptan derivatives, serotoninergic (GAD), post-traumatic stress disorder. S Depression. Bulimia nervosa. antidepressants. A Skin reactions, muscle weakness, CNS P Depression, SAD, social phobia, GAD, P Depression, single dose of 20mg daily.
P Initially, 15 or 30mg per day, taken preferably in the evening. The maintenance dose is usually between 15-45mg per day. Q Under 18 years, not recommended. D Lactation, pregnancy (unless clearly indicated). B Monitor for signs of bone marrow depression (discontinue if occurs). Suicide-related behaviours reported in children and adolescents. Caution: Epilepsy and organic brain syndrome, hepatic or renal failure, heart disease, 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.
Bulimia nervosa, 60mg daily; max. 80mg daily. Q Not recommended. D Severe renal failure, unstable epilepsy. See fluoxetine Drug Prescribing Notes.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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CNS
P Depression: usually 20mg daily. Bulimia nervosa: 60mg daily. OCD: 20-60mg daily. Max. daily dose 80mg. Q Not recommended. D Severe renal failure. Unstable epilepsy, convulsive disorders. See fluoxetine Drug Teofarma Prescribing Notes.
of symptoms. Q Under 18 years, not recommended. D Severe hepatic impairment. Unstable epilepsy (avoid). B Monitor for risk of suicide. Activation of mania or hypomania. Impaired hepatic function PROTHIADEN (use lower or less frequent dose), controlled epilepsy, schizophrenia, heart disease, diabetes, 2NO PROZATAN UCB patients at risk of haemorrhage, elderly. Akathisia TCA. Dothiepin (HCl) 25mg. Red/brown cap. reported. Pregnancy, lactation (only if benefit 2NO marked P25. 100, A4.62; 500, A22.01. S Depression, anxiety associated with SSRI. Fluoxetine (HCl) 20mg. Ivory cap. 30, A14.78. outweighs risk). Driving /using machines. Withdraw gradually. depression. S Major depressive episodes and C Contra: MAOIs (or within 14 days), associated anxiety. Bulimia nervosa. Obsessive 2NO pimozide. Avoid alcohol, serotonergics, St John’s compulsive disorder (OCD). ALSO PROTHIADEN TABLETS Dothiepin (HCl) P Depression: usually 20mg daily. Bulimia wort. Caution: Lithium, diuretics, drugs increasing 75mg. Red sug-ctd tab. marked P75. 28, A3.62; the risk of haemorrhages (e.g. anticoagulants, nervosa: 60mg daily. OCD: 20-60mg daily, max. 100, A12.33. TCAs, NSAIDs), tolbutamide, insulin, diazepam, 80mg daily. P 75-150mg daily in divided doses or as cimetidine, phenytoin, sumatriptan, ECT. Q Not recommended. single dose in the evening. A GI disorders, dyspepsia, dry mouth, D Severe renal failure, unstable epilepsy, R Initial dose: 50-75mg daily. Increase sweating, tremor, dizziness, insomnia, somnolence, convulsive disorders. See fluoxetine Drug gradually under close supervision. anorexia, headache, motor disorders, yawning, Prescribing Notes. 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. marked FLE 20. 30, A15.00. SSRI. Fluoxetine (HCl) 20mg. Green/yellow cap. SERIMEL Clonmel S Major depressive disorders, obsessive marked Lilly 3105. 30, A15.03. 2NO compulsive disorder, bulimia nervosa. See 2NO 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 P Usually 20mg daily. Most patients do 70ml, A21.82. side and breakline on reverse. 50mg-28, A16.24; not require more than 20mg daily. Max. 60mg S Major depressive episodes, obsessive A daily. Bulimia nervosa: 60mg. Hepatic impairment: 100mg-28, 29.37. compulsive disorders (OCD), bulimia nervosa. S Major depressive episodes. Consider lower/less frequent dose (e.g. 20mg every P Admin. as single or divided dose. 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. Q Not recommended. weeks if no response. Range 20-60mg/day. Q Under 18 years, not recommended. Reconsider after 10 weeks if no response. Bulimia D Severe hepatic impairment, unstable SERETRAL Teva nervosa: 60mg daily. 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 marked 9 and 3, the other marked 7176 or 7177 disease, schizophrenia, elderly. Monitor for risk of PROZAMEL Clonmel resp. 50mg-30, A17.94; 100mg-30, A28.42. suicide. Serotonin syndrome. Pregnancy, lactation 2NO (only if essential). Driving/using machines. S Major depressive episodes. SSRI. Fluoxetine (HCl) 20mg. Green cap. 30, Withdraw gradually. P 50mg/day once daily with sufficient A13.78. liquid. Can be increased in steps of 50mg at min 1 C Contra: MAOIs (14 days apart), pimozide. Avoid St John’s wort, serotonergics (eg. S Major depressive episodes and week intervals. Max, 200mg/day. Max. effect 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, and ECG disturbances, GI disorders, thyroid function disturbances, weight increase, QT prolongation, leucocytosis, polydipsia and/or polyuria, diabetes insipidus, confusion, peripheral oedema.
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
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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,
or convulsant disorders. Pregnancy, lactation. B Monitor for suicidal tendencies, esp. at beginning. Activation of mania or hypomania (discontinue). Monitor renal function regularly, especially in elderly. Controlled epilepsy (stop if convulsions occur), ECT (not recommended), diabetes, patients at risk of haemorrhage. Driving/ using machines. Withdraw gradually. C Contra: MAOIs (14 days apart), pimozide. Avoid alcohol, serotonergics e.g. 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. A282.13. 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 A107.92; 200mg-60, A123.04; 300mg100mg-60, irregularities, 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 hypoglycaemics, oral anticoagulants, drugs affecting platelet function (e.g. NSAIDs, most TCAs), lithium, diuretics, phenytoin, sumatriptan, CYP2D6 substrates, changeover from other antidepressants. A GI disorders, dry mouth, dyspepsia, tremor, dizziness, insomnia, somnolence, anorexia, male sexual disorders, asthenia, tiredness, hot flushes, sweating, rash, chest pain, palpitations, tinnitus, headache, motor disorders, paraesthesia, hyperaesthesia, anxiety, agitation, menstrual disorders, impaired vision.
OCD
3.4
disease, hypotension, history of seizures, patients at risk for aspiration pneumonia. Monitor diabetic patients. May increase metabolic risk. May occur: Tardive dyskinesia, neuroleptic malignant syndrome, lipid changes. Driving/operating machines. Pregnancy (only if benefit outweighs risk), lactation (avoid). XR tab. contain lactose. 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.
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, A15.03; 30mg-30, A22.53.
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
107
3.4 MOOD
DISORDERS, BULIMIA NERVOSA,
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.
OCD
CNS
A5.12. S Depression where sleep disturbance, anxiety or agitation are present.
2NO
ALSO SURMONTIL CAPSULES Trimipramine (maleate) 50mg. Green hard cap. marked SU 50. 28, A5.75. P 50-100mg as single dose, 2 hours before SERTRANICHE Niche retiring. Q Not recommended. 2NO SSRI. Sertraline 50mg, 100mg. White film-ctd tabs. D Known risk of narrow angle glaucoma. Risk of urinary retention related to 50mg: Oval, slightly biconvex, scored on one side urethroprostatic disorders. Recent MI. Pregnancy & and marked with S3 on reverse. 100mg: Round, bevel-edged, scored. 50mg-28, A17.84; 100mg-28, lactation (unless essential). B Caution: Elderly, history of epilepsy or A29.21. recent convulsions, urinary retention, glaucoma, S Major depressive episodes. hyperthyroidism, cardiovascular disorders, blood P Usual dose, 50mg daily; may be increased to 100mg daily, max. 200mg. Max. effect dyscrasis, alcoholism, pre-existing brain damage, seen after 2-4 weeks. Continue treatment at least ECT, patients more susceptible to postural hypotension and sedation, chronic constipation 6 months after symptom remission. (risk of paralytic ileus), prostatic hypertrophy, Q Under 18 years, not recommended. hepatic/renal insufficiency. May occur: D Severe hepatic impairment, unstable Cardiovascular and hepatic adverse events. Keep epilepsy. patients with severe depression under close B Monitor for risk of suicide. Caution: surveillance. Insomnia or nervousness at the start History of mania/hypomania, controlled epilepsy, of treatment may require reduced doses or ECT, diabetes, bleeding abnormalities, cardiac transient symptomatic treatment. Discontinue if disease, schizophrenia, elderly. Potential for sudden manic episodes occur. Monitor for suicidal serotonin syndrome. Pregnancy/lactation (only if behaviour. Contains lactose. benefit outweighs risk). Driving/using machines. C Contra: Sulpiride. Not recommended: Withdraw gradually. Alcohol, clonidine and related compounds, a and C Contra: MAOIs incl. moclobemide and b sympathomimetics. Caution: Antiepileptics, selegiline (14 days apart), pimozide. Avoid: St serotoninergic antidepressants, antihypertensives, John’s wort, serotonergics (e.g. tryptophan, fenfluramine and 5-HT agonists), alcohol. Caution: atropine and other atropinic substances, other CNS depressants, thalidomide, guanethidine, zopiclone. oral anticoagulants, drugs affecting platelet function (e.g. NSAIDs, most TCAs, phenothiazines), A See SPC. lithium, diuretics, phenytoin, sumatriptan, Novartis cimetidine, diazepam, tolbutamide, hypoglycaemic TEGRETOL drugs, changeover from use of other 2MO antidepressants. Dibenzazepine. Carbamazepine 100mg white A GI disorders, dyspepsia, dry mouth, scored tab. marked B/W on one side and GEIGY sweating, headache, motor disorders, paraesthesia, on reverse; 200mg white scored tab. Marked C/G hypoaesthesia, insomnia, somnolence, anorexia, on one side and G/K on reverse; 400mg white sexual disorders, tiredness, hot flushes, skin rash, oblong tab. scored and marked CG/CG one side chest pain, palpitations, tinnitus, agitation, and scored with tab. name on reverse. 100mg-100, anxiety, menstrual disorders, impaired vision. A4.16. 200mg-100, A7.69. 400mg-50, A7.57; 400mg-56, A8.47.
SURMONTIL
sanofi-aventis 2 M O
2NO TCA. Trimipramine (maleate) 25mg. White to pale yellow, circular, biconvex, film-ctd tab., marked SURMONTIL on one side and 25 reverse. 25mg-50,
ALSO TEGRETOL ORAL SUSPENSION Carbamazepine 100mg/5ml. Sugar-free liquid. 300ml, A7.27. S Treatment of mania and prophylaxis of
manic-depressive psychosis. Alcohol withdrawal symptoms. V Mania and manic-depressive illness, initially 100-200mg daily in divided doses increasing gradually until symptoms controlled; max. 1600mg daily.
2MO ALSO TEGRETOL RETARD Carbamazepine 200mg beige-orange cap.-shaped scored controlledrelease Divitab marked TEGRETOL 200 one side and HC/HC on reverse; 400mg brown-orange cap.shaped scored controlled-release Divitab marked TEGRETOL 400 one side and ENE/ENE on reverse. 200mg-50, A4.76; 400mg-50, A9.37. V Same total daily dose as above but in two divided doses. 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.
VALDOXAN
Servier
2NO Melatonergic agonist. Agomelatine 25mg. Orangeyellow, oblong, film-ctd tab. marked with company logo. 28, A37.80. S Major depressive episodes. P 25mg once daily at bedtime. After 2 weeks of treatment, if no improvement may be increased to 50mg once daily at bedtime. Treat for at least 6 months. No dosage tapering needed on discontinuation. R 65 years and over, caution. Do not use in elderly patients with dementia. Q Under 18 years, not recommended. D Hepatic impairment (i.e. cirrhosis or active liver disease). Lactation. B History of mania or hypomania (discontinue if manic symptoms develop). Monitor suicidal behaviour or thoughts. Elevations of serum transaminases (discontinue if q 3xULN);
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
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 perform liver function tests in all patients at 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. fluvoxamine, ciprofloxacin). Caution: Moderate CYP1A2 inhibitors (eg. propranolol, grepafloxacine, enoxacine), alcohol (avoid). A Headache, migraine, dizziness, somnolence, insomnia, fatigue, anxiety, GI disorders, hyperhidrosis, back pain.
MOOD
DISORDERS, BULIMIA NERVOSA,
5HT/NA reuptake inhibitor. Venlafaxine 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 VEDIXAL Rowex days between each increment. If no response after 2-4 weeks, no benefit to be gained from 2NO treatment. Treatment usually requires 4-6 months 5HT/NA reuptake inhibitor. Venlafaxine (as of therapy or longer. Renal impairment (GFR 10hydrochloride) 37.5mg, 75mg. Pale red-brown 70ml/min): Reduce dose by 25-50%. Haemodialysis: oblong tab. coded 3 and scored tab. coded 7 on Half dose, postpone administration until dialysis is each half, resp. 37.5mg-56, A18.07; 75mg-56, completed. Mild-moderate hepatic impairment: A30.13. S Treatment of depressive illness including Reduce dose by 50%; further reduction may be depression accompanied by anxiety. Prevention of required in some patients. R Start on lowest recommended dose. relapses of the intial episode of depression or Q Under 18 years, not recommended. prevention of the recurrence of new episodes. B For prescribing information, see P To be taken with food. Initiation and venlafaxine Drug Presc. Notes. Contains sucrose. maintenance: 75mg. May be increased to 150mg 37.5mg cap. contains ponceau 4R red. 75mg and per day in 2 divided doses if needed. In more severely depressed or hospitalised patients, 150mg 150mg cap. contain sunset yellow. in 2 divided doses may be given initially and VENLAFAXINE TEVA Teva increased by up to 75mg every 2 or 3 days until desired response achieved. Max dose: 375mg/day. 2 N O Gradually reduce to usual dosage according to 5HT/NA reuptake inhibitor. Venlafaxine (HCl) patient response and tolerance. Moderate renal/ 37.5mg, 75mg. Contains lactose. Mottled peach, hepatic impairment, reduce dose by 50%. round, flat bevelled tabs scored and marked 9 on R Use lowest effective dose. one side of score and 3 on reverse. On opposite Q Under 18 years, not recommended. side of tab: 37.5mg marked with 7380; 75mg D Children and adolescents under 18 years marked with 7382. Only 75mg can be divided into with Major Depressive Disorder. For other equal halves. 37.5mg-56, A21.67; 75mg-56, prescribing information, see venlafaxine Drug A36.12. Presc. Notes. S Major depressive episodes. P Swallow whole with liquid once daily VEDIXAL XL Rowex same time each day during meal. Initially, 75mg. 2NO May be increased to 150mg, then to 225mg. Patients not responding, doses up to 375mg 5HT/NA reuptake inhibitor. Venlafaxine (as (limited experience). Increase doses at intervals of hydrochloride) 37.5mg, 75mg, 150mg. Resp. light grey, flesh-coloured and orange prolonged-release 2 weeks or more with min. 4 days between each hard caps. containing white to off-white pellets. increment. If no response after 2-4 weeks, no 37.5mg-7, A3.04; 75mg-28, A17.47; 150mg-28, benefit to be gained from treatment. Duration 4-6 A29.45. months or longer in some cases. Hepatic/renal impairment, reduce dose 25-50% (see SPC). S Major depressive episodes. Q Under 18 years, not recommended. P Swallow whole with food. Effective B For prescribing information, see dose 75-225mg. Initially, 75mg. May be increased venlafaxine Drug Presc. Notes. to 150mg, then to 225mg if unsatisfactory response. Patients not responding, doses up to VENLIFT Ranbaxy 375mg (limited experience). Increase doses at intervals of 2 weeks or more with a minimum of 4 2 N O days between each increment. If no response after 5HT/NA reuptake inhibitor. Venlafaxine 37.5mg, 2-4 weeks, no benefit to be gained from 75mg. Peach coloured, mottled, uncoated, shieldtreatment. Treatment usually requires 4-6 months shaped tab. debossed with V and 2 or V and 4, of therapy or longer in some cases. Hepatic/renal resp., on one side. 37.5mg-56, A19.94; 75mg-56, impairment, reduce dose (see SPC). Patients with A33.26. cardiovascular disorder/ hypertension, as per S Treatment of major depressive disorder elderly. incl. depression accompanied by anxiety. Following R Start with lowest effective dose. initial response, prevention of relapses of the Q Under 18 years, not recommended. initial episode of depression or prevention of D Patients at high risk of a serious cardiac recurrence of new episodes. ventricular arrhythmia or uncontrolled P Take with food and sufficient fluid at hypertension. Children and adolescents under 18 same time each day. 75mg/day in 2 divided doses. years. Other 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 evaluation and at least 3-4 weeks of therapy. VENEX XL Clonmel Maintain lowest effective dose. In more severely 2NO depressed or hospitalised patients, may be
OCD
3.4
increased by up to 75mg/day every 2 or 3 days until desired response achieved (close supervision). In patients requiring r300mg, initiate treatment under specialist supervision. Max 375mg/day. Prevention of relapse or for prevention of recurrence of a new episode: Dosage similar to that used during index episode; regularly re-assess benefit of long-term therapy. Renal impairment (GFR 10-70mg/ml): Reduce dose by 25-50%. Moderate hepatic impairment (PT 14-18 seconds): Reduce dose by 50%. Severe renal/hepatic impairment: Insufficient data, consider reducing dose by q 50%. Not suitable for haemodialysis patients. R Start with lowest effective dose. Q Under 18 years, not recommended (increased risk of suicide related behaviours).
2NO ALSO VENLIFT XL Venlafaxine 75mg, 150mg. Resp. size 1 or size 0 cap. with pink or caramel opaque cap and body marked RVn on cap and strength on body in black ink. 75mg-28, A19.28; 150mg-28, A32.51. S Treatment of major depressive episodes. Prevention of recurrence of major depressive episodes. P 75mg once daily with food and sufficient fluid at the same time each day. May be increased to 375mg/day maximum at interval of 2 weeks or more. If clinically warranted, dosage increased intervals may be more frequent, but not less than 4 days. Maintain lowest effective dose. Continue treatment for at least 6 months following remission. Mild and moderate hepatic
WARNINGS D Contraindications: Conditions where the product should not be given. Hypersensitivity to a drug (and/or excipients) or its class is assumed to be a contraindication in all entries.
B Special Precautions: Conditions where special attention is required, or tests are to be performed. Serious side effects that need attention.
C Drug Interactions: Drugs which may affect, or be affected by, the product if prescribed together.
A
Adverse Drug Reactions: Most frequently reported side effects.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
109
3.5 NAUSEA,
VOMITING, VERTIGO
impairment: consider 50% dose reduction. Severe hepatic impairment: Caution, consider q50% dose reduction. Renal impairment: 30ml/minQccQ70ml/ min, caution. ccQ30ml/min, 50% dose reduction. R Use lowest effective dose; careful monitoring. Q Not recommended. D Identified very high risk of serious cardiac ventricular arrhythmia (significant left ventricular dysfunction, NYHA Class III/IV) or uncontrolled hypertension, closed-angle glaucoma, micturition disorders (obstruction of urinary flow). B For prescribing information, see venlafaxine Drug Presc. Notes.
CNS
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.
S Episode of major depression. P Initially 15mg daily. Titrate according to response, usually 15-45mg. Q Not recommended.
XANAX
ALSO ZISPIN SOLTAB Mirtazapine 15mg, 30mg,
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, A3.52; 0.5mg100, A6.77; 1mg-100, A14.13. S Anxiety when the disorder is severe, disabling or causing extreme distress. VENLOFEX Gerard P 0.5-1mg daily in divided doses, 2NO increasing in increments not greater than 1mg 5HT/NA reuptake inhibitor. Venlafaxine HCl eq. to every 3-4 days to 3-4 daily. Max. treatment duration, 8-12 weeks. 75mg, 150mg. Resp. flesh or scarlet opaque hard R 0.25mg twice daily. prolonged-release cap. marked VEN on one side Q Not recommended. and 75 or 150 on the other. 75mg-28, A22.79; D Myaesthenia gravis, severe respiratory 150mg-28, A38.48. or hepatic insufficiency sleep apnoea syndrome. S Major depressive episodes. B Tolerance, physical and psychic P Swallow whole with food. Effective pendence, anterograde amnesia, psychiatric and dose 75-225mg. Initially, 75mg. May be increased paradoxical reactions (e.g restlessness, agitation, to 150mg, then to 225mg. Patients not irritability, aggressiveness, delusion, rages, responding, doses up to 375mg (limited experience). Increase doses at intervals of 2 weeks nightmares) C Alcohol, CNS depressants. or more with 4 days min between increments. If A Amnesia, drowsiness, depression, no response after 2-4 weeks, no benefit to be gained from treatment. Treatment usually requires pychiatric and paradoxical reactions, dependence. 4-6 months of therapy or longer in some cases. Gerard Renal impairment (GFR 10-70ml/min): Reduce dose ZISMIRT by 25-50%. Severe renal impairment (cc Q 30ml/ 2NO min) and haemodialysis: Half dose, postpone Presynaptic a2-antagonist. Mirtazapine 30mg. administration until dialysis is completed. MildNormal convex, buff film-ctd tab. debossed MR moderate hepatic impairment: Reduce dose by scoreline 30 on one side and G on reverse. 28, A19.29. 50%. R Start on the lowest recommended dose. 2 N O Q Under 18 years, not recommended. ALSO ZISMIRT OROTAB Mirtazapine, 15mg, 30mg, B For prescribing information, see or 45mg. White, round, orodispersible tabs venlafaxine Drug Presc. Notes. marked 36, 37 or 38 resp. 15mg-30, A11.04; 30mg30, A22.53; 45mg-30, A33.99. VENSIR XL Morningside S Episode of major depression. P Initially 15 or 30mg. Effective dose 2NO usually between 15 and 45mg daily. May be given 5HT/NA reuptake inhibitor. Venlafaxine (as HCl) 75mg, 150mg. 75mg: Peach opaque hard cap. with in sub doses equally divided over the day (once in the morning, once at night-time). Discontinue red radial circular bands, filled with 6 white to gradually if no response within 2-4 weeks, or if off-white round biconvex film-ctd mini tabs. patient completely symptom-free for 4-6 months. 150mg: Dark orange hard cap. with white radial Swallow tab. with sufficient amount of water. circular bands, filled with 12 white to off-white Q Under 18 years, not recommended. round biconvex film-ctd mini tas. 75mg-28, D Pregnancy (unless essential), lactation. A17.47; 150mg-28, A29.45. S Major depressive disorder. Prevention of B Monitor for signs of bone marrow depression. Caution: Epilepsy and organic brain relapses of initial episode of depression or syndrome, hepatic or renal insufficiency, cardiac prevention of recurrence of new episodes. diseases, hypotension, micturition disturbances, P Swallow whole with liquid. Take with food. Major depressive disorder: Effective dose 75- acute narrow-angle glaucoma and increased intraocular pressure, diabetes mellitus, schizophrenia, 150mg/day. Initially, 75mg. If clinical response unsatisfactory, may be increased after 3 weeks. In history of mania/hypomania, elderly. Discontinue if jaundice occurs. Contains lactose. Driving/using more severely depressed or hospitalised patients, daily dose may be increased by up to 75mg every machines. C MAOIs (contraindicated), alcohol 2 or 3 days. Max recommended dose: 375mg. (avoid). Caution: Benzodiazepines, other SSRIs, Prevention of relapse or recurrence: Dose similar potent CYP3A4 inhibitors, CYP3A4 inducers, to that used during index episode; re-assess regularly benefit of long-term therapy. Moderate warfarin. renal impairment (GFR 10-30ml/min): Reduce dose A Increase in appetite and weight gain, somnolence, dizziness, headache, oedema. 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.
110
2NO
Pharmacia 45mg. Round, white, standard bevelled-edge
ZISPIN
Schering-Plough
2NO Presynaptic a2-antagonist. Mirtazapine 30mg. Redbrown oval scored tab. marked Organon and coded TZ/5. 28, A19.30.
orodispersible tabs. with a code on one side: 15mg (TZ/1), 30mg (TZ/2), 45mg (TZ/4) 30(15mg), A14.48; 30(30mg), A28.94; 30(45mg), A43.41. 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).
3.5 NAUSEA, VOMITING, VERTIGO
ALOXI
Helsinn Birex
2JNO 5-HT3 antagonist. Palonosetron (HCl) 250mcg/5ml. Soln for inj. in vial. 5ml, A89.25. S Prevention of: Acute nausea and vomiting associated with highly emetogenic cancer chemotherapy; nausea and vomiting associated with moderately emetogenic cancer chemotherapy. P 250mcg admin. as single IV bolus over 30 secs approx. 30 mins before start of chemotherapy. Do not repeat within 7 days. Highly emetogenic chemotherapy: Efficacy may be enhanced by corticosteroid admin. prior to chemotherapy. Q Under 18 years, not recommended. D Lactation, pregnancy (unless essential). B History of constipation or signs of subacute intestinal obstruction; monitor. Existent/ risk of prolongation of QT interval; caution. Driving/operating machines. C Caution: Drugs increasing QT interval. A Headache, GI disorders, dizziness.
BY-VERTIN
Ergha
2MO H1 agonist. Betahistine (HCl) 8mg, 16mg. 8mg white tab marked B8, 16mg white scored tab marked B16. 8mg-120, A9.40; 16mg-84, A13.18. 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.
DOMERID
Rowex
2MO Dopamine antagonist. Domperidone (maleate) 12.72mg equiv. 10mg of domperidone. White,
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 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.
NAUSEA,
round biconvex film-ctd tabs. marked PA on one side and 933 and 934 resp. on reverse. 4mg-30, 8mg-30, A187.61. S Nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for prevention and treatment of post-operative nausea and vomiting (PONV). P Emetogenic chemo/radiotherapy: Range 8-32mg a day. 8mg 1-2 hrs before treatment, followed by 8mg 12 hrs later. Then 8mg twice daily for up to 5 days. Highly emetogenic chemotherapy: Rectal, IV or IM administration on day of treatment. Continue for up to 5 days with 8mg orally twice daily. PONV: Prevention, 16mg 1 hr prior to anaesthesia; or 8mg 1 hr prior to anaesthesia followed by 2 further doses of 8mg at eight hourly intervals. Treatment, IV or IM admin. recommended. Moderate/severe hepatic impairment: Max. 8mg daily. R PONV: Limited experience. EMEND MSD Q Emetogenic chemo/radiotherapy: 2-18 years, single IV dose of 5mg/m2 over 15 min just 2NO before chemotherapy, followed by 4mg orally 12 Anti-emetic. Aprepitant 125mg, 80mg. Both hrs later. Then admin. oral treatment according to opaque hard caps. 125mg: White body and pink body area for up to 5 days: 0.6-1.2m2, 4mg three cap marked with 462 and 125mg. 80mg: White times a day; q1.2m2, 8mg three times a day. body and cap marked with 461 and 80mg. 3 day Under 2 years or body area Q0.6m2, not pack: 125mg-1 and 80mg-2, A60.91; 125mg-5, recommended. PONV: Slow IV inj. recommended. A101.53; 80mg-2, A40.61. D Children after intra-abdominal surgery. S As combination therapy for the Pregnancy, lactation. prevention of acute and delayed nausea and B Hypersensitivity to other 5HT3 receptor vomiting associated with highly emetogenic antagonists. Sub acute intestinal obstruction, cisplatin-based cancer chemotherapy and the adenotonsillar surgery (may mask occult bleeding). prevention of nausea and vomiting associated Contain lactose. with moderately emetogenic cancer C Caution: Tramadol, potent CYP3A4 chemotherapy. inducers (i.e. phenytoin, carbamazepine, P 125mg swallowed whole on day 1 and rifampicin). 80mg once daily days 2 and 3 as part of regimen A Constipation, headache, sensations of incl. a corticosteroid and a 5-HT3 antagonist (see flushing or warmth, hiccups. SPC). Admin. orally 1 hour prior to chemotherapy on day 1 and in the morning on days 2 and 3. EMIZOF Gerard Q Under 18 years, not recommended.
2J
A126.16;
2NO
Selective 5HT3 receptor-antagonist. Ondansetron (HCl dihydrate) 4mg, 8mg. Film-ctd yellow, round biconvex tab.; marked 41, 42 resp. 4mg-30, A140.17; 8mg-10, A69.49. S Management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. Prevention and treatment of postoperative nausea and vomiting (PONV). 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, 4mg 3 times a day; over 1.2m2, 8mg 3 times a day. EMITAL Teva PONV: Parenteral administration recommended, 2NO see relevant SPC. D Hypersensitivity to other 5HT3 receptor Selective 5HT3 receptor-antagonist. Ondansetron (as HCl dihydrate) 4mg, 8mg. White to off-white, antagonists. Pregnancy, lactation.
ALSO IVEMEND Fosaprepitant 115mg. White to off-white powder for solution for infusion. 10ml-1, A33.64. P 115mg by IV infusion over 15 mins on Day 1 only as part of regimen incl. a corticosteroid and a 5-HT3 antagonist. Admin 30 mins prior to chemotherapy. See SPC and Emend for Day 2 and 3. 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
3.5
B Monitor patients with signs of subacute intestinal obstruction. Not indicated in children after intra-abdominal surgery. Arrhythmias or cardiac conduction disorders (no data). Adenotonsillar surgery (may mask occult bleeding). C Caution: Antiarrhythmic agents or bblockers, phenytoin, carbamazepine, rifampicin, tramadol. A Constipation, headache, flushing, IV inj. site reactions.
KYTRIL
Roche
2N 5HT3 antagonist. Granisetron (HCl) 1mg/ml. 1ml, 3ml amps. for IV inf. 1ml, A82.73; 3ml, A209.38. S Prophylaxis or treatment of nausea and vomiting induced by cytostatic therapy. 1mg/ml also indicated for management of post operative nausea and vomiting. P Post-operative nausea and vomiting: 1mg diluted to 5ml, by slow IV inj. (over 30secs.). Repeat at intervals of 10mins. if necessary; max. 3mg in 24 hours. Chemotherapy induced nausea and vomiting: 3mg diluted to 15ml infusion, by slow IV inj. (over 30secs.) OR diluted to 20-50ml inf. by IV inf. over 5 mins. Repeat at intervals of 10 min if necessary; max. dose 9mg in 24 hours. Q Single dose of 40mcg/kg body weights (up to 3mg) by IV inf. diluted in 10-30ml inf. fluid and admin. over 5 mins. prior to start of cytostatic therapy. One additional dose of 40mcg/kg body weight (up to 3mg) may be admin. within a 24hours period if required and not until at least 10 mins. after initial inf.
2NO ALSO KYTRIL TABLETS Granisetron (HCl) 1mg, 2mg. White triangular film-ctd tabs. 1mg-10, A89.62; 2mg-5, A89.62. S Prevention of acute and delayed nausea and vomiting associated with cytostatic therapy. P 1mg twice daily or 2mg once daily for up to 1 week following therapy. First dose within 1 hour before start of cytostatic therapy. Q Not recommended. D Lactation. B Pregnancy. Subacute intestinal obstruction. A Headache, constipation, lassitude, rash. Transient rise in liver enzymes.
MAXOLON
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
111
3.5 NAUSEA,
VOMITING, VERTIGO
CNS
Q Over 12 years and weighing 35kg or more, as per adults. Less than 5kg, not recommended. 5-15kg, 10mg twice daily. More than 15kg, 30mg twice daily. D Pregnancy (unless essential), lactation. Patients with prolactin releasing pituitary tumours, B Not for use in the immediate postGI haemorrhage, mechanical obstruction or operative period (up to 3-4 days) following pyloroplasty or gut anastomosis. Assess risk/benefit: perforation. Hepatic impairment. B Severe renal insufficiency, especially if Significant hepatic or renal impairment, prolonged use. Parkinsonâ&#x20AC;&#x2122;s disease. If vomiting persists, reassess C Anticholinergics, CYP3A4 inhibitors, patient to exclude underlying disorder (e.g. antacids or antisecretory agents, phenothiazines or cerebral irritation). Caution: History of atopy other neuroleptics, dopaminergic agonists. (including asthma) or porphyria. May occur: A Raised serum prolactin. Neuroleptic malignant syndrome, elevation of serum prolactin levels. Rare hereditary problems of ONDANSETRON (INN) Teva galactose intolerance, Lapp lactose deficiency of glucose-galactose malabsorption. 2NO C Anticholinergics, phenothiazines, CNS Selective 5HT3 receptor-antagonist. Ondansetron drugs (MAOIs, sympathomimetics), serotonergic (as hydrochloride dihydrate) 4mg, 8mg. Yellow, drugs, alcohol. oblong film ctd tabs marked with 4 and 8 resp. A Extrapyramidal reactions. 8mg scored on reverse, not to be broken for half dose admin. 4mg-30, A126.16; 8mg-10, A55.60; MOTILIUM McNeil Healthcare 8mg-50, A 277.00. twice daily. D Phaeochromocytoma. Epilepsy. GI haemorrhage, mechanical obstruction or perforation. Pregnancy, lactation (unless essential).
D Hypersensitivity to other 5HT3 receptor antagonists. Children with body surface Q 0.6 m2. Lactation. B Monitor patients with signs of subacute intestinal obstruction. Arrhythmias or cardiac conduction disorders (no data). Adenotonsillar surgery (may mask occult bleeding). Contains lactose (tabs). Pregnancy. C Caution: Antiarrhythmic agents or bblockers, phenytoin, carbamazepine, rifampicin, tramadol. A Constipation, local burning sensation following insertion of suppositories, headache, flushing, IV inj. site reactions.
ROWEX DOMERID
Rowex
2Y
Dopamine antagonist. Domperidone (maleate) 12.72mg equiv. 10mg of domperidone. White, round, biconvex tab. marked Dm10. 10, A2.87; 20, A4.62. S Nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort, 2K regurgitation of gastric contents. 2NO P 1-2 three to four times daily before Antidopaminergic. Domperidone 10mg. White to ALSO ONDANSETRON AMPOULES Ondansetron meal. Max. daily dose: 80mg. Initial duration: 4 faintly cream circular biconvex film-ctd tabs. 10, (HCl dihydrate) 2mg per ml. Soln for inj. 2ml, A3.67; 20, A6.43. weeks. Severe renal insufficiency (prolonged A58.70; 4ml, A83.84. therapy), reduce dose to once or twice daily. 2K 2NO Q Over 12 years and weighing 35kg or ALSO MOTILIUM FASTMELTS Domperidone 10mg. ALSO ONDANSETRON TABLETS (INN) more, as for adults. Less than 35kg, unsuitable. White or off-white circular orodispersible tab. 10, Ondansetron (HCl dihydrate) 4mg, 8mg. Film-ctd A3.99; 20, A7.00. oval tab. marked O on one side and 4 or 8 on the D Prolactin-releasing pituitary tumour S Nausea. other. 4mg-30, A140.12; 8mg-10, A69.49; 8mg-30, (prolactinoma). GI haemorrhage, mechanical obstruction or perforation. P Up to 10mg 3 times daily and at night A208.42. B Lactose intolerance, galactosaemia or for 2 weeks max. Q Under 16 years, not recommended. Over ONDRAN Pinewood glucose/galactose malabsorption (unsuitable). Pregnancy. Lactation, hepatic impairment (not 16 years, as per adults. 2NO recommended). D Prolactin-releasing pituitary tumour Selective 5HT3 receptor-antagonist. Ondansetron C CYP3A4 inhibitors. (prolactinoma). GI haemorrhage, mechanical (HCl dihydrate) 2mg/ml. Soln for inj. and inf. 2ml-5 A Increase in prolactin levels. obstruction or perforation. Hepatic and/or renal amp., A57.55; 4ml-5 amp., A82.74. impairment. Pregnancy, lactation. 2NO SERC Solvay B Contains aspartame. ALSO ONDRAN TABLETS Ondansetron (HCl C Strong CYP3A4 inhibitors (e.g. 2MO dihydrate) 4mg, 8mg. Film-ctd yellow, round ketoconazole, ritonavir, erythromycin). Histamine analogue. Betahistine (diHCl) 8mg. biconvex tab.; marked 41, 42 resp. 4mg-10, A Raised serum prolactin. White tab. marked with symbol and 256. 120, A45.30; 8mg-10, A69.45. A9.71. S Management of nausea and vomiting
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. 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.
2MO ALSO MOTILIUM SUSPENSION Domperidone 1mg per ml. Oral susp. 200ml, A2.08. S Nausea and vomiting. P 10-20ml 3 to 4 times daily before meals. Max 80ml daily. Reevaluate after 4 weeks. Q 0.25-0.5mg/kg body weight 3-4 times daily before meals to max. 2.4mg/kg daily. Do not exceed 80mg daily. Over 12 years and weighing 35kg or more, as per adults.
2MO ALSO MOTILIUM SUPPOSITORIES Domperidone 10mg, 30mg, 60mg. 10mg-6, A1.80; 30mg-6, A1.81; 60mg-6, A7.31. S Nausea and vomiting. P 1 (60mg) suppos. 2 times daily.
112
induced by cytotoxic chemotherapy and radiotherapy. Prevention and treatment of postoperative nausea and vomiting (PONV). P Emetogenic chemo/radiotherapy: IV or orally (8mg twice daily for up to 5 days). Highly 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/ glucocorticoids. PONV: Prevention, orally (16mg 1 hr prior to anaesthesia) or 8mg 1 hr prior to anaesthesia followed by 2 doses of 8mg at 8 hr intervals. 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 body area 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, 4mg 3 times a day; over 1.2m2, 8mg 3 times a day. PONV: Treatment and prevention, slow IV inj.
2MO
ALSO SERC-16 Betahistine (diHCl) 16mg. White tab. marked 267 and symbol on reverse. 84 (Cal/ Pk), A13.58. S Vertigo, tinnitus and hearing loss due to 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.
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,
VOMITING, VERTIGO
3.5
origin. P 1 three times daily. Q Not recommended.
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 2K ALSO STUGERON 15MG Cinnarizine 15mg. White 20 min. before end of surgery. Regurgitation during emergency surgery: 25mg by IV before scored tab. marked JANSSEN one side S/15 on anesthesia. reverse. 15, A2.61. Q Not indicated. S Motion sickness. P 2 two hours before, then 1 eight hourly D Pregnancy, lactation (limited data). B Glaucoma, obstructive disease of GI during journey. tract, prostatic hypertrophy, severe HF. Driving or 2NO Q Under 5 years, not recommended; 5-12 operating machines. Abrupt withdrawal. ALSO STEMETIL INJECTION Prochlorperazine years, half adult dose. C Additive effects with alcohol, mesylate 12.5mg/ml; Amps. 10 x 1ml, A4.03; 10 x D See SPC. barbiturates, other CNS depressants. Pethidine. 2ml, A5.08. P 12.5mg by deep IM inj. VALOID Amdipharm Other anticholinergics (enhance side-effects). A Urticaria, drug rash, drowsiness, dry Q Not recommended. 2MO mouth, nose and throat, blurred vision, D Comatose states, bone marrow Antihistamine. Cyclizine (HCl) 50mg. White, tachycardia, urinary retention, constipation, depression. Liver damage. biconvex branded scored tabs. coded T4A. 100, restlessness, nervousness, insomnia, auditory/ visual B Undiagnosed and prolonged vomiting. A4.39. hallucinations, cholestatic jaundice. Warn patients of impaired dexterity. CVD. S Prevention and treatment of nausea Pregnancy. and vomiting due to motion sickness, narcotic VERTIGON Gerard C CNS depressants, alcohol, analgesics, analgesics, radiotherapy, Meniere’s disease and antihypertensives, antidepressants, antidiabetics. 2MO other forms of vestibular disturbance. A CNS disturbances. Anticholinergic Histamine analogue. Betahistine (diHCl) 8mg white P 50mg orally, up to 3 times a day. effects. ECG and endocrine changes, allergic tab. marked BH 8 one side, G on reverse; 16mg effects and extrapyramidal symptoms occur rarely Q 6-12 years, 25mg orally up to 3 times a white tab. marked BH 16 and 256. 8mg-120, day. Under 6 years, not recommended. Over 12 at low doses. A9.70; 16mg-84, A13.57. years, as per adults. S Vertigo, tinnitus and hearing loss due to STUGERON McNeil Healthcare 2 M O Meniere’s syndrome. 2MO ALSO VALOID INJECTION Cyclizine (lactate) 50mg. P Initially 8-16mg three times daily; maintenance, 24-48mg daily. Selective calcium entry blocker. Cinnarizine 25mg. Ampoules containing 1ml soln. for inj. 5, A10.14. Q Not recommended. White scored tab. marked JANSSEN one side, S/25 S Prevention and treatment of nausea A D Phaeochromocytoma. and vomiting due to narcotic analgesics, general on reverse. 50, 4.11. B Bronchial asthma. Peptic ulcer. S Vertigo of vestibular or cerebrovascular anaesthetics, radiotherapy, Meniere’s disease and A Gastric upset. White tab. marked with tab. name and strength. 5mg-250, A11.09. S Vertigo due to Meniere’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.
Anti-doping: A Guide for Prescribers Classifications
2........This medicinal product is permitted for use in sport. 5........ This medicinal product contains substance(s) prohibited
for use in sport. Athletes requesting to use this product are required to apply for a TUE. m.. This medicinal product contains substance(s) prohibited for use in sport, in men only. Male Athletes requesting to use this product are required to apply for a TUE. c. This medicinal product contains substance(s) prohibited for use in sport during the competition period only. Athletes requesting to use this product in-competition are required to apply for a TUE. 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. d.....This medicine is permitted but should be declared on the Doping Control Form at the time of testing. 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.
Despite granting of 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.
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, A140.18; 8mg-10, A69.50; 8mg-30, A208.46. S Management of nausea and vomiting due to cytotoxic chemotherapy and radiotherapy. Prevention of post-operative nausea and vomiting.
2NO ALSO ZOFRAN ZYDIS Ondansetron 4mg, 8mg. Oral lyophilisate. White round tab. 4mg-10, A50.73; 8mg-10, A101.45. P Emetogenic chemo/radiotherapy: 8mg 12 hours before treatment. Then 8mg orally after 12 hours. Highly emetogenic chemotherapy: 24mg orally, (taken with 12mg oral dexamethasone), 1-2 hours before treatment. Post-operative nausea and vomiting prevention: 16mg orally, 1 hour prior to anaesthesia. Treatment, use IV route. 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/
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
113
3.6 EPILEPSY,
CNS
SEIZURES
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.
P Initially 400-800mg IV inf., followed by continuous inf. of up to 10mg/kg/day. Max. 2.5g daily. Q Usually 20-30mg/kg/day IV inf. Max 40mg/kg/day but only if valproic acid levels monitored. D Active liver disease, personal or family history of severe hepatic dysfunction (esp. drug related), porphyria. B Risk of severe liver damage (incl. hepatic failure); increased risk in children Q 3 years. Liver function tests advised before therapy and in first 6 months, especially when risk or history of liver disease. Pancreatitis may occur, esp. in young children (prompt medical evaluation in patients with acute abdominal pain). Monotherapy recommended in children Q 3 years at risk of liver toxicity and pancreatitis. Blood cell count, bleeding time and coagulation tests advised before therapy. Monitor for suicidal thoughts/ 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 protein bound agents (eg. aspirin), cimetidine, 2MO erythromycin, carbapenem antibiotics, EPANUTIN Parke-Davis ALSO EIPLIM SYRUP Sodium valproate 200mg/5ml. colestyramine, rifampicin, newer anti-epileptics 2MO Clear, cherry red syrup. 300ml, A7.00. (e.g. topiramate). Hydantoin. Phenytoin Na+ 25mg, 50mg, 100mg, 2MO A Congenital disorders, transient GI 300mg. White/purple cap., white/pink cap., white/ ALSO EPILIM LIQUID Sodium valproate 200mg/ disorders, increased alertness, aggression, orange cap. and white/green cap. resp. All marked 5ml. Sugar-free. 300ml, A7.00. hyperactivity, behavioural deterioration, confusion, with cap. name and strength. 25mg-28, A1.10; 2MO thrombocytopenia, transient hair loss, 25mg-500, A11.39; 50mg-28, A1.11; 50mg-500, ALSO EPILIM CHRONO Sodium valproate (as amenorrhoea, dysmenorrhoea, allergic reactions, A11.63; 100mg-84, A6.95; 100mg-500, A15.17; valproate and valproic acid) 200mg, 300mg, increased weight. 300mg-28, A6.95; 300mg-100, A10.00. 500mg. Violet oblong, film-ctd prolonged release S Tonic-clonic seizures, partial seizures. tab. 200mg-100, A8.25; 300mg-100, A12.38; FRISIUM sanofi-aventis Prevention and treatment of seizures following 500mg-100, A20.64. 2NO neurosurgery or head injury. Trigeminal neuralgia 2 M O Benzodiazepine. Clobazam 10mg. White tab. (2nd line). ALSO EPILIM CHRONOSPHERE Sodium valproate marked Hoechst one side, scored and coded B/GL P Initially 3-4mg/kg daily increasing (as valproate and valproic acid) 100mg, 250mg, gradually until control; maintenance, usually 200- 500mg, 750mg, 1000mg. Prolong. release granules on reverse. 100, A9.44. S Adjunct in epilepsy. 500mg daily in single or divided doses. in sachets. 100mg-30, A9.79; 250mg-30, A10.02; P 10-20mg daily with increases of 10mg Q Neonates, titrate according to serum 500mg-30, A13.03; 750mg-30, A19.38; 1000mg-30, increments. Max. 60mg daily. Reassess after 4 levels. Others, initially 5mg/kg daily in two divided A18.72. weeks. doses; maintenance, usually 4-8mg/kg daily. Max. S Generalised, partial or other epilepsy. Q Under 3 years, not recommended; 3-12 300mg daily. P Initially 600mg daily increasing by years, up to half adult dose. 2MO 200mg at three day intervals or for Chronosphere D Myasthenia gravis, severe respiratory ALSO EPANUTIN SUSPENSION Phenytoin 30mg/ initially 10-15mg/kg/day increasing at 2-3 day insufficiency, sleep apnoea, severe hepatic 5ml. Oral susp. 500ml, A7.32. intervals. Usual maintenance, 1-2g daily (20-30mg/ insufficiency, drug or alcohol dependence. P Initially 15ml three times daily. kg/day). Max. 2.5g daily. Epilim Chrono and Pregnancy, lactation (use only if essential). Q Under 6 years, 5ml twice daily, Chronosphere may be given once or twice daily. Children (6 months-3 years) other than in increasing to 5ml three or four times daily; 6-12 Q Under 20kg, initially 20mg/kg/day. Over exceptional cases. years, same as adult. 20kg, initially 400mg daily. Max. 40mg/kg daily. B Tolerance, dependence, anterograde 2MO Chronosphere, see adults. Usual maintenance, 20- amnesia, psychiatric and paradoxical reactions may ALSO EPANUTIN INFATABS Phenytoin 50mg. 30mg/kg/day. See SPC. Epilim Chrono not suitable occur. Caution: Pre-existing muscle weakness, Yellow scored triangular chewable tab. 100, for children under 20kg. spinal/cerebellar ataxia. Elderly, acute respiratory A6.37; 112, A12.13. 2N insufficiency, renal/hepatic impairment; reduce P 2 two to four times daily. ALSO EPILIM INTRAVENOUS Sodium valproate dose. Driving/operating machinery. Q Under 6 years, v tab.; 7-12 years, 1 tab. 400mg. Powder in vial plus 4ml WFI. 1, A12.19. C Not recommended: Alcohol. Caution: Both two to four times daily. CNS depressants. S Generalised, partial or other epilepsy, 2NO A Drowsiness, reduced alertness, numbed where oral treatment is not possible. 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. diazepam, disulfiram, oestrogens, H2-antagonists, 112, A15.56. 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. Johnâ&#x20AC;&#x2122;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, C Folic acid antagonists, hypoglycaemics, 500mg. Lilac ent-ctd tabs. 200mg-100, A7.65; oral anticoagulants. 500mg-100, A19.07. A Flushing, thirst, headache, drowsiness, 2MO polyuria, paraesthesia, blood dyscrasias, ALSO EPILIM CRUSHABLE Sodium valproate excitement, rash. 100mg. White circular scored tab. 100, A4.62.
114
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 Q 6 years and over: Initially, 10-15mg/kg/ day; titrate over approx. 3 days to 25-35mg/kg/ day. Admin. in three divided doses with max. 12 GABAPENTIN TEVA Teva hrs between each dose. D Pregnancy, lactation (unless benefit 2MO outweighs risk). GABA analogue. Gabapentin 600mg, 800mg. B Acute pancreatitis (discontinue). Mixed White to off-white, oval shaped, bevelled edged, seizures including absences (caution). Long-term film-ctd tab. engraved 7173 (600mg) or 7174 therapy (q 36 weeks) in children and adolescents (800mg) on 1 side and 93 the other. 600mg-100, (no data). False positive in dipstick tests (total A83.64; 800mg-100, A101.66. urine protein). Driving/operating machines. S Adjunctive therapy in treatment of Contains lactose. partial seizures with and without secondary C Morphine (caution). Take min. 2 hrs generalisation in adults and children r 6 years . after antacid. As monotherapy in treatment of partial seizures A CNS effects eg. somnolence, dizziness, with and without secondary generalisation in ataxia. Infections eg. viral, RTI, UTI. Psychiatric adults and adolescents r 12 years. P Effective dose, 900-3600mg/day. Initiate disorders eg. hostility, confusion, emotional lability. Fatigue, fever, oedema, abnormal gait, by dose titration: 300mg once daily on day 1, pain, flu syndrome, arthralgia, myalgia, purpura, increasing to 300mg twice daily on day 2, then rash, vertigo. Hypertension, vasodilatation, visual 300mg three times daily on day 3. Alternatively disturbances. Respiratory/GI disorders. initiate with 300mg 3 times/day on day 1. Incontinence, impotence. WBC decreased, Thereafter, can be increased in 300mg/day leucopenia, weight gain, appetite change. increments every 2-3 days up to 3600mg/day max. Accidental injury. Aggressive behaviour and Renal impairment, haemodialysis: See SPC. hyperkinesias in children. R Adjust according to renal function. Q q12 years, as per adults. r 6 years: GABITRIL Cephalon Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ kg/day reached by upward titration over a approx. 2 M O Selective inhibitor of GABA uptake. Tiagabine 3 days. Doses up to 50mg/kg/day well tolerated. 5mg, 10mg, 15mg. White film-ctd scored tabs Divide total daily dose in 3 single doses with 12 marked 251, 252 or 253. 5mg-100, A72.26;10mghour interval (max) between doses. 100, A104.16; 15mg-100, A156.24. D Pregnancy, lactation (unless benefit outweighs risk). S Add-on therapy for partial seizures with B Consider discontinuation if acute or without secondary generalisation not controlled pancreatitis develops. Caution in patients with with other AEDs. mixed seizures incl. absences. Assess risks/benefits P Initially 7.5-15mg/day in three divided of prolonged therapy in children and adolescents. doses increasing with weekly increments of 5Monitor for signs of suicidal ideation and 15mg/day. Usual maintenance, 30-50mg/day; max. behaviours. False positive in dipstick tests (total 70mg/day. urine protein). Withdraw gradually. Pregnancy, Q Not recommended. lactation. Driving/operating machinery. D Severely impaired liver function. C Morphine, antacids. Generalised epilepsy, particularly idiopathic forms A IInfections (e.g. viral, UTI, RTI, otitis with absences. media, pneumonia), leucopenia, anorexia, B Withdraw gradually; patients with a increased appetite, psychiatric and nervous system history of serious behavioural problems; perforrm disorders, visual disturbances, vertigo, full blood count if ecchymoses are observed. hypertension, vasodilatation, dyspnoea, bronchitis, Pregnancy, lactation. pharyngitis, cough, rhinitis, GI disorders, facial A Dizziness, tiredness, somnolence. oedema, purpura, rash, pruritus, acne, arthralgia, GERICARB SR Gerard myalgia, back pain, twitching, incontinence, impotence, fatigue, fever, peripheral or 2MO generalized oedema, abnormal gait, asthenia, Dibenzazepine. Carbamazepine 200mg, 400mg. pain, malaise, flu syndrome, decreased WBC, White to yellowish, round, flat, cloverleaf shaped weight gain. prolonged release tabs with bevelled edge, double-sided cross break-mark, 4 notches on band. GABIN Rowex Can be divided into equal halves. 200mg-56 2MO A4.48; 400mg-56, A8.85. GABA analogue. Gabapentin 100mg, 300mg, S Epilepsy. Generalised tonic-clonic. Partial 400mg. Hard gelatine caps. with white (100mg), seizures. yellow (300mg) or orange (400mg) opaque body. P Initially 100-200mg once or twice daily 100mg-100, A16.92; 300mg-100, A39.20; 400mgincreasing slowly to 400-600mg morning and A 100, 45.36. night. Max daily dose of 1600-2000mg may be S Partial seizures with and without required. secondary generalisation as adjunctive therapy Q Not suitable under 5 years. 5-10 years: (r6 years) or as monotherapy (r12 years). Initially 200mg at night (or 100mg morning and P 12 years and over, 900-3600mg/day night). Maintenance: 100-200mg morning and 200swallowed whole with water. Titrate 300mg once 400mg at night. 10-15 years: Initially 200mg at daily (Day 1), twice daily (Day 2) and three times night (or 100mg morning and night); maintenance: daily (Day 3); alternatively 300mg three times daily 100-400mg morning and 400-600mg at night. on Day 1. Can then be increased in 300mg/day D Bone marrow depression, AV increments every 2-3 days up to max. 3600mg/day. conduction abnormalities, acute intermittent Admin. in three divided doses with max. 12 hrs porphyria. between each dose. Discontinue gradually over B Evaluate benefit/risk: Haematological min. 1 week. Renal impairment: See SPC. disturbances, disturbed Na+ metabolism, severe emotions, confusion, fatigue, headache, dizziness, muscle weakness, fine tremor, double vision.
EPILEPSY,
SEIZURES
3.6
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.
INOVELON
Eisai
2MO Carboxamide derivative. Rufinamide 100mg, 200mg, 400mg. Pink, ovaloid, slightly convex, filmctd tabs. scored on both sides, marked A261, A262, A263 resp. 100mg-10, A6.39; 200mg-60, A61.94; 400mg-60, A121.55. S Adjunctive therapy in treatment of seizures associated with Lennox-Gastaut syndrome. P Initially 400mg preferably with food; may be increased by 400mg/day increments every 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
115
3.6 EPILEPSY,
CNS
SEIZURES
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.
behaviour. C Phenytoin, carbamazepine, phenobarbitone, primidone, rifampicin, lopinavir/ ritonavir, ethinyloestradiol/levonorgestrel LAMICTAL GSK combination may increase dose requirement. Valproate reduces dose requirement. 2MO Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. A Aggression, irritability, headache, somnolence, dizziness, tremor, insomnia, ataxia, Pale yellow, multi-faceted, superelliptical tabs. marked with strength and code on reverse. 25mg- nystagmus, diplopia, blurred vision, GI disorders, 56, A25.21; 50mg-56, A39.57; 100mg-56, A68.26; skin rash, tiredness. 200mg-56, A122.88. accidental injury, myalgia, infection, nasopharyngitis, cough increased, rash, thrombocytopenia.
LAMORO
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, 2NO A123.91. Pyrrolidone derivative. Levetiracetam 250mg, S r 13 years: Adjunctive or monotherapy 500mg, 1000mg. Blue, yellow and white scored treatment of partial seizures and generalised 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 A69.18; 1000mg-60, A134.93. adjunctive therapy; may also be given as initial 2NO antiepileptic drug). Children aged 2 to 12 years: 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, 250mg twice daily increased to 500mg twice daily for 2 weeks, followed by 25mg once daily for 2 after 2 weeks; can be further increased by 250mg weeks; maintenance 100-200mg once daily or in 2 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. 2NO Q Under 2 years, not recommended. 2-12 ALSO KEPPRA CONCENTRATE Levetiracetam years: Monotherapy: Initially 0.3 mg/kg/day (once 100mg/ml. Soln for inf. 10-100mg/ml, A190.98. a day or two divided doses) for 2 weeks; followed S Monotherapy in partial onset seizures by 0.6 mg/kg/day (once a day or two divided with or without secondary generalisation (r 16 doses) for 2 weeks; thereafter usual maintenance years) in newly diagnosed epilepsy. Adjunctive 1-10 mg/kg/day (once a day or two divided doses), therapy when oral admin. is temporarily not higher doses up to 15 mg/kg/day may be required. feasible. Adjunctive therapy: With valproate: Initially 0.15 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 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 twice daily every 2 weeks depending upon divided doses). With enzyme inducers (except response. Max. 1500mg twice daily. Adjunctive valproate): Initially 0.6 mg/kg/day (two divided therapy: As IV inf. over 15 min; dose as per doses) for 2 weeks; followed by 1.2 mg/kg/day Keppra Oral Soln. Renal impairment, see SPC. (two divided doses) for 2 weeks; thereafter usual Q As IV inf; dose as per Keppra Oral Soln. maintenance 5-15 mg/kg/day (once a day or two D Pregnancy (unless clearly necessary), divided doses). Without valproate or enzyme lactation. inducers: Initially 0.3 mg/kg/day (once a day or B Severe hepatic impairment, driving or two divided doses) for 2 weeks; followed by 0.6 operating machines. Withdraw gradually. Soln. mg/kg/day (once a day or two divided doses); contains glycerol. Concentrate contains sodium. thereafter usual maintenance 1-10 mg/kg/day C Caution: Probenecid, NSAIDs, (once a day or two divided doses). See SPC for sulfonamides, methotrexate. dose escalation in all cases. A Asthenia, somnolence, amnesia, ataxia, B Renal/hepatic impairment. Rare skin convulsion, dizziness, headache, tremor, reactions e.g. Stevens Johnson syndrome. Promptly depression, emotional lability, hostility, insomnia, evaluate patients who develop rash. Pregnancy, nervousness, diarrhoea, dyspepsia, nausea, lactation. Hypersensitivity syndrome. Withdraw gradually. Monitor for suicidal ideation and anorexia, weight increase, vertigo, diplopia,
116
Pinewood
2MO Triazine Lamotrigine 25mg, 50mg, 100mg, 200mg. Dispersible white to off-white round tabs. 25mg60, A19.53; 50mg-60, A30.50; 100mg-60, A52.92; 200mg-60, A96.11. S Epilepsy, partial and generalised seizures incl. tonic-clonic seizures and the seizures associated with Lennox Gastaut Syndrome. P Monotherapy: Initially 25mg once daily for 2 weeks, followed by 50mg once daily for 2 weeks; thereafter usual maintenance, 100-200mg daily, once daily or in 2 divided doses; max. 500mg daily. Add on therapy: Patients taking valproate: Initially 25mg on alternate days for 2 weeks, followed by 25mg once daily for 2 weeks; maintenance 100-200mg once daily or in 2 divided doses. Patients not taking valproate but taking inducers of lamotrigine glucoronidation: Initially 50mg once daily for 2 weeks, followed by 100mg daily in 2 divided doses for 2 weeks; thereafter usual maintenance dose 200-500mg daily in 2 divided doses; max. 700mg daily. Patients not taking valproate but taking oxcarbazepine and without inducers or inhibitors of lamotrigine glucuronidation: 25mg once daily for 2 weeks, followed by 50mg once daily for 2 weeks; thereafter usual maintenance dose 100-200mg once daily or in 2 divided doses. See SPC for dose escalation in all cases. Special patient populations: Refer to SPC. Q Under 2 years, not recommended; 2-12 years: Patients taking valproate with/without any other AED: Initially 0.15mg/kg once daily for 2 weeks, followed by 0.3mg/kg daily once daily for 2 weeks; thereafter increase by max. 0.3mg/kg every 1-2 weeks until optimal response; usual maintenance 1-5mg/kg once daily or in 2 divided doses; max. 200mg daily. Patients not taking valproate but taking inducers of lamotrigine glucoronidation: Initially 0.6mg/kg daily in 2 divided doses for 2 weeks, followed by 1.2mg/kg daily in 2 divided doses for 2 weeks; thereafter increase by max. 1.2mg/kg every 1-2 weeks until optimum response; usual maintenance 5-15mg/kg daily given in 2 divided doses; max. 400mg daily. Patients taking oxcarbazepine without any 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,
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 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 somnolence, dizziness, tremor, insomnia, ataxia, Lamotrigine 25mg, 50mg, 100mg, 200mg. White nystagmus, tremor, diplopia, blurred vision, GI to off-white round tab., debossed with L12, L13, disorders, tiredness. L14 or L15 (resp.) on one side. 25mg-56, A13.44; 50mg-56, A21.10 ; 100mg-56, A36.40; 200mg-56, LARIG Rowex A66.51. 2MO S Adults and adolescents q 13 years: As adjunctive or monotherapy treatment of partial Triazine. Lamotrigine 25mg, 50mg, 100mg, 200mg. seizures and generalised seizures, incl. tonic-clonic White, square dispersible tab. marked L and seizures; seizures associated with Lennox-Gastaut strength. 25mg-56, A19.57; 50mg-56, A30.56; syndrome; as adjunctive therapy in Lennox-Gastaut 100mg-56, A52.97; 200mg-56, A96.15. syndrome (may also be the initial antiepileptic S As adjunctive or monotherapy in the drug). Children and adolescents aged 2-12 years: treatment of epilepsy, for partial seizures and Adjunctive treatment of partial seizures and generalised seizures, incl. tonic-clonic seizures and generalised seizures, incl. tonic-clonic seizures and the seizures associated with Lennox-Gastaut seizures associated with Lennox-Gastaut syndrome; Syndrome. monotherapy of typical absence seizures. P Monotherapy: Initially 25mg once daily P Monotherapy: Initially 25mg once daily for 2 weeks; usual maintenance, 100-200mg once for 2 weeks, followed by 50mg once daily for 2 daily or in 2 divided doses; max. 500mg daily. Add weeks; thereafter usual maintenance, 100-200mg on therapy: Initially in those taking enzyme daily, once daily or in 2 divided doses; max. inducing anti-epileptic drugs (AEDs) and not 500mg daily. Adjunctive therapy with valproate: taking Na+ valproate: 50mg once daily for 2 Initially 12.5mg/day (or 25mg on alternate days) weeks; usual maintenance dose 200-500mg/day in for 2 weeks, followed by 25mg once daily for 2 2 divided doses; max. 700mg daily. Patients taking weeks; maintenance 100-200mg once daily or in 2 valproate (or AEDs with interaction unknown): divided doses. Adjunctive therapy with enzyme Initially 25mg on alternate days for 2 weeks; inducers (except valproate): Initially 50mg once maintenance 100-200mg once daily or in 2 divided daily for 2 weeks, followed by 100mg daily in 2 doses. See SPC for dose escalation in all cases. divided doses for 2 weeks; thereafter usual Hepatic impairment: Moderate, half adult dose; maintenance dose 200-400mg daily in 2 divided severe, 1/4 adult dose. doses; max. 700mg daily. Adjunctive therapy Q Under 2 years, not recommended. Over without valproate or enzyme inducers: Initially 12 years, as per adults. 2-12 years: Only as add-on 25mg once daily for 2 weeks, followed by 50mg therapy. Initially in those taking enzyme inducing daily in 2 divided doses for 2 weeks; thereafter AEDs and not taking valproate, 0.6mg/kg daily in usual maintenance dose 100-200mg daily in 2 2 divided doses for 2 weeks; usual maintenance 5divided doses. See SPC for dose escalation in all 15mg/kg daily in 2 divided doses; max. 400mg cases. daily. In those taking valproate, initially 0.15mg/kg Q Under 2 years, not recommended. 2-12 once daily for 2 weeks; usual maintenance 1-5mg/ years: Monotherapy: Initially 0.3 mg/kg/day (once 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 0.6 mg/kg/day (once a day or 2 divided doses) for calculated dose 1-2mg, 2mg may be taken on 2 weeks; thereafter usual maintenance 1-10 mg/ alternate days for first 2 weeks. If calculated dose kg/day (once a day or 2 divided doses), higher Q 1mg, do not admin. doses up to 15 mg/kg/day may be required. B Renal/hepatic impairment. Rare skin Adjunctive therapy: With valproate: Initially 0.15 reactions eg. Stevens Johnson syndrome. Promptly 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 Hypersensitivity syndrome. Pregnancy, lactation maintenance 1-5 mg/kg/day (once a day or 2 (only if benefit outweighs risk). Driving/using divided doses); maximum 200mg/day. With machines. Withdraw gradually. enzyme inducers (except valproate): Initially 0.6 C Enzyme inducing anti-epileptic drugs mg/kg/day (2 divided doses) for 2 weeks; followed (AEDs) (eg. phenytoin, primidone, carbamazepine, by 1.2 mg/kg/day (2 divided doses) for 2 weeks; phenobarbitone) may increase dose requirement. thereafter usual maintenance 5-15 mg/kg/day A Rash, irritability, headache, drowsiness, (once a day or 2 divided doses). Without valproate insomnia, dizziness, tremor, vision disorders, GI or enzyme inducers: Initially 0.3 mg/kg/day (once a disorders, tiredness, arthralgia, pain, back pain. 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 Pfizer reactions eg. Stevens Johnson syndrome. Promptly LYRICA 2MO evaluate patients who develop rash. Hypersensitivity syndrome. Withdraw gradually. GABA analogue. Pregabalin 25mg, 50mg, 75mg, Monitor for suicidality (increased risk below 18 100mg, 150mg, 200mg, 300mg. Hard gelatine cap.,
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.
EPILEPSY,
SEIZURES
3.6
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 Adjunctive therapy in adults with partial seizures with or without secondary generalisation. P Initially, 150mg per day in either two or three divided doses. May be increased to 300mg per day after 1 week and to max. 600mg per day after an additional week. Discontinue gradually over a min. of 1 week. Renal impairment: Adjust dosage (see SPC). R Reduce dose in renal dysfunction. 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.
MYSOLINE
Acorus
2MO Pyrimidinedione. Primidone 250mg. White scored tab. marked MM. 100, A16.00; 1000, A18.79. S Grand mal and psychomotor (temporal lobe) epilepsy. Also of value in focal or Jacksonian seizures, myoclonic jerks and akinetic attacks. P Initially 125mg at night increasing at 3 day intervals by 125mg to 500mg daily, then increase by 250mg to max. 1.5g daily. Usually twice daily. Q Initially same regimen as adults but use 125mg increments. Maintenance: up to 2 years, 250-500mg; 2-5 years, 500-750mg; 6-9 years, 750mg-1g; 9-12 years, 750mg-1.5g. All as daily doses, best divided in 2 equal amounts morning and evening. D Porphyria. Pregnancy (only if essential; vit K1 suppl). B Children, elderly, debilitated patients. Impaired renal, hepatic or respiratory function. Metabolised to phenobarbitone; potential for tolerance/ dependance. Withdraw gradually. Vit. D suppl. in long term therapy. Megaloblastic anaemia requiring discontinuation. Lactation (monitor baby for sedation). C Caution: Other anticonvulsants, coumarin anticoagulants, oral contraceptive steroids, other CNS depressants (eg. alcohol, barbiturates), St John’s Wort. A Drowsiness, listlessness, ataxia, visual disturbances, nystagmus, nausea; all usually transient.
NEURONTIN
Pfizer
2MO 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. S Partial seizures with and without secondary generalisation as adjunctive therapy (r6 years) or as monotherapy (r12 years).
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
117
3.6 EPILEPSY,
CNS
SEIZURES
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 NEUROSTIL Teva healing drugs, analgesics, antacids, antipsychotics, antidepressants, tolbutamide. 2MO A Cardiovascular complications, CNS GABA analogue. Gabapentin 100mg, 300mg, effects, blood dyscrasias, hepatitis, liver damage, 400mg. Resp. grey, orange or brown hard cap. intestinal nephritis, GI upset, pruritus, headache, marked resp. 93 and 38, 93 and 39 or 93 and 40. hirsutism, hypersensitivity reactions. 100mg-100, A19.89; 300mg-100, A46.12; 400mg100, A53.37. RANGABAX Ranbaxy S Partial seizures with and without 2MO secondary generalisation as adjunctive therapy GABA analogue Gabapentin 100mg, 300mg, (r3 years) or as monotherapy (r12 years). 400mg, 800mg. 100mg: White opaque hard cap. P Initially 900mg/day. Titrate by 300mg (size 4) marked G100 on cap and body. 300mg: once daily on day 1, 300mg twice daily on day 2, Ivory opaque hard cap. (size 0) marked G300 on 300mg three times daily on day 3. Can be cap and body. 400mg: Orange opaque hard cap. increased by 300mg/day increments in 3 equally (size 0) marked G400 on cap and body. 800mg: divided doses, up to 3600mg/day max. Effective White to off-white, oval, biconvex film-ctd tab. dose range 900-3600mg daily. Max 12 hours between doses. Renal impairement, haemodialysis: marked G800 on one side. 100mg-100, A14.48; 300mg-100, A30.93; 400mg-100, A37.47; 800mgSee SPC. 100, A82.91. R Adjust according to renal function. Q 3-12 years, initially 10-15mg/kg/day in 3 S As adjunctive therapy in the treatment of partial seizures with and without secondary divided doses; titrate over 3 days. r 5 years: 25generalisation in adults and children r 6 years. As 35mg/kg/day in 3 divided doses. 3-5 years: 40mg/ monotherapy in treatment of partial seizures with kg/day in 3 divided doses. Doses up to 50mg/kg/ and without secondary generalisation in adults day well tolerated. Max 12 hours between doses. and adolescents r 12 years. B Mood and behavioural disturbances P Effective dose, 900-3600mg/day. Initiate may occur. Monitor for suicidal ideation. by dose titration: 300mg once daily on day 1, Withdraw gradually over at least 1 week. Not increasing to 300mg twice daily on day 2, then effective in absence seizures. Pregnancy (only use 300mg three times daily on day 3. Alternatively, if clearly needed), lactation. Driving/using initiate with 300mg 3 times/day on day 1. machines. Thereafter, can be increased in 300mg/day C Caution: Morphine, antacids. False increments every 2-3 days up to 3600mg/day max. positive readings reported with Ames N-Multistix See SPC. Renal impairment, haemodialysis: See SG dipstick test. SPC. A Fatigue, ataxia, dizziness, somnolence. R Adjust according to renal function. See SPC. Q q 12 years, as per adults. r 6 years: Initially, 10-15 mg/kg/day. Effective dose: 25-35mg/ PRO-EPANUTIN Parke-Davis kg/day. Doses up to 50mg/kg/day well tolerated. 2NO Divide total daily dose in 3 single doses with a 12 Hydantoin. Fosphenytoin Na+ 75mg per ml (equiv. hour interval (max) between doses. to 50mg PE). Clear, colourless to pale yellow soln. B Consider discontinuation if acute in vial. 10 x 10ml, A439.08. pancreatitis develops. Caution in patients with mixed seizures incl. absences. Assess risks/benefits S Status epilepticus of tonic-clonic type. of prolonged therapy in children and adolescents. Prevention and treatment of seizures connected with neurosurgery or head trauma. Substitute for Monitor for signs of suicidal ideation and behaviours. False positives in dipstick tests (total oral phenytoin where oral admin. is not possible. urine protein). Withdraw gradually. Driving/ P Status epilepticus: initially 15mg PE/kg operating machinery. by IV inf. at a rate of 100-150mg PE/min. C Morphine (monitor for CNS depression). Maintenance: 4-5mg PE/kg daily by IV inf. or IM inj. Treatment and prophylaxis of seizures: initially Antacids.
P Initially 300mg once daily on day 1, increasing to 300mg twice daily on day 2, then 300mg three times daily on day 3. Thereafter dose can be increased using increments of 300mg per day given in three divided doses to a max. of 3600mg per day. Effective dose range is 9003600mg daily. Q Under 6 years, not recommended; 6-12 years, 25-35mg/kg/day given in three divided doses. Initially 10mg/kg/day on day 1, 20mg/kg/day on day 2 and 25-35mg/kg/day on day 3. B Elderly, haemodialysis, renal impairment (see SPC), mood and behavioural disturbances. Ability to drive or operate machinery may be affected. Pregnancy, lactation. Discontinuation of gabapentin and/or additional or substitution of alternative therapy should be gradual over a minimum of 1 week. Not effective in absence seizures. C Caution: Morphine, antacids. A CNS effects (somnolence, dizziness, ataxia, nystagmus, tremor), fatigue, headache, diplopia, GI disturbances (nausea, vomiting), rhinitis, amblyopia.
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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.
RIVOTRIL
Roche
2NO Benzodiazepine. Clonazepam 0.5mg, 2mg. Pinkish or white tab. resp. Both quarter-scored marked ROCHE and tab. strength on one side. 0.5mg-100, A5.12; 2mg-100, A10.68. S All forms of epilepsy. P Initial R1mg daily. Increase gradually to maintenance dose, usually 4-8mg daily. R Initially R 0.5mg daily. Q Up to 1 year, initially R 0.25mg daily, maintenance, 0.5-1mg daily. 1-5 years, R 0.25mg daily, maintenance, 1-3mg daily. 5-12 years, initially R 0.5mg daily, maintenance, 3-6mg daily. For all ages increase gradually to maintenance dose.
2NO ALSO RIVOTRIL INJECTION Clonazepam 1mg in solvent plus 1ml diluent. Amp. 5, A3.80; 10, A7.59. S Status epilepticus. P 1mg by slow IV inj. Q 0.5mg by slow IV inj. See lit. D Acute pulmonary insufficiency, severe respiratory insufficiency, sleep apnoea, myasthenia gravis, severe hepatic insufficiency. Pregnancy, lactation. B Elderly, debilitated, spinal or cerebellar ataxia, alcohol/drug abuse, cirrhosis. Withdraw gradually. May modify reaction times. Closely monitor for depressive illness/suicidal ideation (or history of). Driving/operating machinery. Contains lactose. C Alcohol, hydantoins, phenobarbital, Na+ valproate. CYP450 inhibitors/inducers. Phenytoin, primidone. Anaesthetics, hypnotics, psychoactive drugs, analgesics, muscle relaxants. A Fatigue, muscle weakness, dizziness, ataxia, light-headedness, somnolence, muscular hypotonia, co-ordination disturbances.
SABRIL
sanofi-aventis
2MO GABA transaminase inhibitor. Vigabatrin 500mg. 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 (Westâ&#x20AC;&#x2122;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
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
CNS 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 disorder, headache, dizziness, paraesthesia, disturbance in attention and memory impairment, mental impairment (thought disturbance), tremor, visual field defect, vision blurred, diplopia, nystagmus, GI disorders, fatigue, oedema, irritability, excitation (children), agitation, aggression, nervousness, depression, paranoid reaction.
EPILEPSY, 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
SEIZURES
3.6
chest pain, myalgia, hypersensitivity, fatigue, asthenia, abnormal feeling, gait disturbance, irritability, malaise, pyrexia, weight decreased/ increased.
TRILEPTAL
Novartis
Janssen-Cilag 2 N O
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 TEGRETOL Novartis Syndrome seizures. 2MO P Initially 25mg daily for 1 week, then Dibenzazepine. Carbamazepine 100mg white increased by 25-50mg daily, in 2 divided doses at scored tab. marked B/W on one side and GEIGY 1-2 week intervals. Target dose: Monotherapy, on reverse; 200mg white scored tab. Marked C/G 100-200mg/day; maximum 500mg. Adjunctive on one side and G/K on reverse; 400mg white therapy, 200mg-400mg in 2 divided doses; oblong tab. scored and marked CG/CG one side maximum 1600mg/day. Migraine: Initially 25mg and scored with tab. name on reverse. 100mg-100, daily for 1 week, then increased by 25mg/day at 1A4.16. 200mg-100, A7.69. 400mg-50, A7.57; week intervals. Recommended dose 100mg/day in 400mg-56, A8.47. 2 divided doses. Maximum 200mg/day. Tab. should 2MO not be broken. Q Aged 4 to 16 years: Begin titration at ALSO TEGRETOL ORAL SUSPENSION 25mg nightly for 1 week, then increase at 1 or 2 Carbamazepine 100mg/5ml. Sugar-free liquid. week intervals by 1 to 3mg/kg/day in 2 divided 300ml, A7.27. doses; recommended daily dose 5-9mg/kg/day in 2 S Epilepsy, generalised tonic clonic and divided doses. Doses up to 30mg/kg/day generally partial seizures. well tolerated. Under 4 years: Not recommended. P Initially 100-200mg once or twice daily D Pregnancy (unless benefits outweigh increasing slowly to 800mg-1.2g daily; in some risks), lactation. cases 1600mg daily may be necessary. B Caution: Hepatic and moderate to Q Liquid is recommended for children severe renal impairment. Patients at risk of under 5 years. Up to 1 year, 5-10ml daily; 1-5 nephrolithiasis; maintain adequate hydration. May years, 10-20ml daily; 5-10 years, 400-600mg daily; occur: increased incidence of mood disturbances 10-15 years, 600mg-1g daily. and depression, acute myopia with secondary 2MO angle-closure glaucoma (rare). Monitor serum ALSO TEGRETOL RETARD Carbamazepine 200mg bicarbonate; reduce dose or withdraw if metabolic beige-orange cap.-shaped scored controlledacidosis develops. Monitor for weight loss. release Divitab marked TEGRETOL 200 one side Hereditary problems of galactose intolerance, the and HC/HC on reverse; 400mg brown-orange cap.Lapp lactase deficiency or glucose-galactose shaped scored controlled-release Divitab marked malabsorption. Driving/using machine. Withdraw TEGRETOL 400 one side and ENE/ENE on reverse. gradually. 200mg-50, A4.76; 400mg-50, A9.37. C Caution: Phenytoin, carbamazepine, V Same total daily dose as above but in digoxin, oral contraceptives, lithium, two divided doses. hydrochlorothiazide, metformin, pioglitazone, 2MO glibenclamide, agents causing nephrolithiasis. ALSO TEGRETOL SUPPOSITORIES Carbamazepine A Nasopharyngitis, anaemia, anorexia, 125mg, 250mg. Suppos. 125mg-5, A7.05; 250mg-5, decreased appetite, depression, abnormal A9.16. behaviour, aggression, agitation, anger, anxiety, S Short term (max. 7 days) treatment of bradyphrenia, confusional state, depressed mood, patients for whom oral therapy is not possible. disorientation, expressive language disorder, V When switching from oral therapy insomnia, altered mood, mood swings, dizziness, increase dose by 25%; max. 1g daily in divided parathesia, somnolence, amnesia, balance disorder, doses rectally. cognitive disorder, convulsion, abnormal D AV conduction abnormalities unless coordination, attention disturbance, dysarthria, paced. dysgeusia, hypoaesthesia, intention tremor, B Cardiac, hepatic or renal disease. lethargy, memory impairment, mental impairment, Perform liver function tests periodically. Blood nystagmus, impaired psychomotor skills, sedation, dyscrasias. Pregnancy, lactation. Test blood tremor, diplopia, blurred vision, visual disturbance, regularly. ear pain, tinnitus, vertigo, dyspnoea, epistaxis, C MAOIs, anticoagulants, antiepileptics, nasal congestion, rhinorrhoea, GI disorders, lithium, macrolide antibiotics (erythromycin), some dysuria, nephrolithiasis, pollakiuria, alopecia, Ca++ antagonists (verapamil, diltiazem), pruritus, rash, arthralgia, muscle spasms, muscle twitching, muscular weakness, musculoskeletal dextropropoxyphene, viloxazine, cimetidine,
Dibenzazepine. Oxcarbazepine 150mg, 300mg, 600mg. Pale grey green, yellow and pink oval film-ctd tabs. scored both sides. 150mg-50, A8.85; 300mg-50, A18.41; 600mg-50, A36.71.
2NO ALSO TRILEPTAL ORAL SUSPENSION Oxcarbazepine 60mg/ml. Susp. with oral dosing syringe. 250ml, A36.50. S Partial seizures with or without secondary generalised tonic clonic seizures. For use as monotherapy or adjunctive therapy. P Initially 600mg daily in two divided doses. Increase if necessary at weekly intervals using increment of up to 600mg daily. Usual daily dose 600-2400mg daily. Q Under 6 years, not recommended; over 6 years, initially 8-10mg/kg daily in two divided doses. Increase if necessary at weekly intervals using increments of up to 10mg/kg daily. Max. 46mg/kg daily. B History of hypersensitivity to carbamazepine. Monitor Na+ levels in at risk patients prior and during therapy. Cardiac disease. Pregnancy, lactation. C Phenobarbitone, phenytoin, carbamazepine, Na+ valproate, lamotrigine, contraceptives, felodipine, verapamil, lithium. A Fatigue, asthenia, dizziness, headache, somnolence, agitation, amnesia, apathy, ataxia, impaired concentration, confusion, depression, emotional lability, nystagmus, tremor, nausea, vomiting, constipation, diarrhoea, abdominal pain, hyponatraemia, acne, alopecia, rash, diplopia, vertigo, vision disorders.
VIMPAT
UCB
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.
2O ALSO VIMPAT SYRUP Lacosamide 15 mg/ml. Clear, slightly yellow to yellow-brown sln. 200ml, A50.75.
2O ALSO VIMPAT SOLUTION FOR INFUSION 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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3.7 PARKINSON’S, ALZHEIMER’S 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 myocardial infarction or heart failure). Syrup contains Na+ propylhydroxybenzoate, Na+ methylhydroxybenzoate, sorbitol and aspartame. Sln for inf. contains Na+. Tabs contain soya lecithin. C Caution: Carbamazepine, lamotrigine, pregabalin, starting or ending treatment with rifampicin or St John’s Wort, phenytoin, phenobarbital. A Depression, dizziness, balance disorder, headache, abnormal coordination, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, diplopia, blurred vision, vertigo, nausea, vomiting, constipation, flatulence, pruritus, gait disturbance, asthenia, fatigue, fall, skin laceration.
ZARONTIN
Parke-Davis
2MO Succinimide. Ethosuximide 250mg/5ml. Clear slightly yellow to slightly pink raspberry flavoured syrup. 200ml, A4.33. S Petit mal. P 500mg daily increased as necessary by 250mg daily at intervals of 4-7 days up to 2g daily. Q Under 6 years, initially 250mg daily adjusted by small increments to optimum response; 6-12years, same as adult. B Pregnancy, lactation. Hepatic or renal impairment. Withdraw gradually. C Phenytoin, valproic acid. A Gastric and CNS disturbances. Skin rashes, blood dyscrasias, SLE.
ZONEGRAN
Eisai
2NO 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 weekly intervals in increments of up to 100mg. Renal/hepatic impairment and patients not receiving CYP3A4-inducing agents: Consider two weekly intervals. Can be admin. once or twice daily after titration phase. Q Under 18 years, not recommended. 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.
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AND
MS
CNS
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. 3.7 PARKINSON’S, ALZHEIMER’S AND C Other anticholinergic psychotropics, antihistamines, antiparkinsonian drugs, MS antispasmodics, quinidine, levodopa, carbidopa, ADARTREL GSK metoclopramide, alcohol. A Anticholinergic effects. Confusion in 2MO high doses. Dopamine agonist. Ropinirole (as HCI) 0.25mg, 0.5mg, 2mg. White, yellow and pink resp. oval Clonmel shaped film-cted tabs., marked GS on one side and APO-GO MLE, TES, and GYG resp. on the other. 0.25mg-12, 2 M A2.89; 0.5mg-28, A12.26; 2mg-28, A33.87. Dopamine agonist. Apomorphine HCI 10mg/ml. S Moderate to severe idiopathic restless Soln for inj. in prefilled syringe, Penject. 30mg/ legs syndrome. 3ml-5, price on request. P Initially 0.25mg once daily for 2 days. If S Disabling motor fluctuations (’on-off’ well tolerated can increase to 0.5mg once daily for phenomena) in patients with Parkinson’s disease, remainder of week 1. Week 2: 1mg once a day. which persist despite individually titrated The dose may be increased by 0.5mg/week over treatment with levodopa and/or other dopamine next 2 weeks to 2mg once a day (average dose). agonists. In some patients, dose may be increased gradually P Initially 1mg (0.1ml) by SC inj. If to a max. of 4mg once a day. Evaluate response inadequate response after 30 min., admin. 2nd dose after 3 months. of 2mg (0.2ml) by SC inj. Dose may be increased R Clearance decreased in patients over 65 incrementally with r 40 min. between inj., until years of age. Increase dose gradually, titrate satisfactory motor response obtained. against response. Maintenance: Once appropriate dose determined, Q Under 18 years, not recommended. admin. single SC inj. at 1st signs of an ’off’ D Severe renal or hepatic impairment. episode. Max. total daily dose is 100mg and max. Lactation. Pregnancy (unless benefits outweigh individual bolus inj. is 10mg. Levodopa/ risks). domperidone dose may be reduced in some B Not for neuroleptic akathisia, tasikinesia patients. Continuous Infusion: Patients with a or secondary restless legs syndrome. May cause good ’on’ period response during initiation, but worsening of symptoms with earlier onset, and whose overall control remains unsatisfactory, or reoccurrence of symptoms in early morning hours who require many and frequent inj. may be (review if occurs). Major psychotic disorders (do commenced on or transferred to continuous SC not use unless benefits outweigh risks). Impulse inf. For dose, see SPC. control disorders reported at high doses. Caution: Q Under 18 years, contraindicated. Moderate hepatic impairment, severe D Respiratory depression, dementia, cardiovascular disease. Driving/operating machines. psychotic diseases, hepatic insufficiency. Contains lactose. Intermittent treatment in patients who have an C CYP1A2 inhibitors. May require dose ’on’ response to levodopa marred by severe adjustment if HRT or smoking stopped or dyskinesia or dystonia. Children and adolescents. introduced. Avoid neuroleptics and other centrally Pregnancy, lactation. active dopamine antagonists. B Renal, pulmonary or cardiovascular A GI disorders, nervousness, syncope, disease, persons prone to nausea and vomiting. somnolence, dizziness (incl. vertigo), fatigue. Initiation in elderly/debilitated patients. Preexisting cardiac disease/postural hypotension. AKINETON L Farmaceutico SIT Perform regular haematology tests with concomitant levodopa use. May cause 2MO exacerbations of neuropsychiatric disturbances. Anticholinergic. Biperiden (HCl) 2mg. White circular, biplanar tab. with bisecting score on one Consider dose reduction/termination of therapy if somnolence experienced. Driving / operating side. 100, A5.48. machines. Contains Na+ metabisulphite (ampoules) S Parkinsonism, drug-induced or bisulphite (pen). extrapyramidal symptoms. C Neuroleptics, clozapine, drugs with a P Parkinsonism: Initially: 1mg twice daily. narrow therapeutic range, antihypertensives. Can increase by 2mg a day to a max. of 16mg daily. Spread doses evenly throughout day. Drug- A Inj. site reactions, nausea, vomiting, transient sedation, somnolence, transient mild induced movement disorder: 1-4mg, one to four confusion, visual hallucinations. times daily as comcomitant medication to the neuroleptic. ARICEPT Pfizer Q 1-2mg one to three times daily.
A Anorexia, agitation, irritability, confusional state, depression, ataxia, dizziness, memory impairment, speech disorder, somnolence, diplopia, weight loss, hypersensitivity, rash, GI disorders, pyrexia.
2MO
2NO
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,
Acetylcholinesterase inhibitor. Donepezil (HCl) 5mg, 10mg. White and yellow round biconvex film-ctd tab marked Aricept on one side and 5 and 10 resp. on reverse. 5mg-28, A64.66; 10mg-28, A90.62. S Mild to moderate severe Alzheimer’s dementia. P Initially 5mg once daily at bedtime. Increase if necessary to 10mg at bedtime after 1
2
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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
month. Initiated and supervised by an experienced physician. Maintain as long as therapeutic benefit. Q Not recommended. D Pregnancy (unless clearly necessary), lactation. B Supraventricular conduction disturbances, history of GI ulceration, bladder outflow obstruction, seizures, asthma, COPD, hepatic impairment. Contains lactose. Driving or using machines. C Avoid cholinergics and anticholinergics. Caution: Neuromuscular blockers, CYP3A4 inducers and inhibitors, CYP2D6 inhibitors (eg fluoxetine), alcohol, anaesthetics. A Diarrhoea, muscle cramps, fatigue, nausea, vomiting, insomnia, cold, anorexia, hallucinations, agitation, aggressive behaviour, syncope, dizziness, rash, urinary incontinence, headache, pain, accident.
ARIPEZ
Teva
2NO Acetylcholinesterase inhibitor. Donepezil (HCl) 5mg, 10mg. White and yellow film-ctd oval tabs, marked 93 on one side and 7320 and 7321 on reverse resp. 5mg-28, A49.68; 10mg-28, A70.66. S Symptomatic treatment of mild to moderately severe Alzheimer’s dementia. P Initially 5mg once daily in the evening, just prior to retiring. Can be increased after one month to 10mg once daily. Max. daily dose, 10mg.Initiated and supervised by experienced physician. Q Not recommended. D Hypersensitivity to piperidine derivatives. Lactation, pregnancy (unless clearly necessary). B Anaesthesia, cardiovascular conditions (vagotonic), GI conditions, history of asthma or obstructive pulmonary disease (caution). May cause bladder outflow obstruction, seizures. Contains lactose. Withdraw gradually. C Avoid other acetylcholinesterase inhibitors, cholinergics and anticholinergics. Caution: CYP3A4 inhibitors and CYP2D6 inhibitors (e.g. fluoxetine), succinylcholine, neuro-muscular blockers, b-blockers. A GI/abdominal disturbances, muscle cramps, fatigue, insomnia, headache. Common cold, anorexia, hallucinations, agitation, aggressive behaviour, syncope, dizziness, rash, pruritus, urinary incontinence, pain, accident. Extrapyramidal symptoms.
AVONEX
Biogen
2NT Immunomodulator. Interferon b1a 30mcg. Prefilled syringe: 30mcg/0.5ml; vial with BIO-SET device: 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 without evidence of progression between relapses. Treatment of patients who have a single demyelinating event with an active inflammatory process if severe enough to warrant treatment with IV corticosteroids, if alternative diagnoses have been excluded, and if high risk of developing clinically definite MS. P 30mcg once weekly by IM inj. Discontinue if patient develops chronic progressive disease. Q Under 12 years, not recommended.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
121
3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
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, AZILECT Lundbeck CABASER Pharmacia increased libido and hypersexuality have been reported. Contains lactose. Pregnancy, lactation. 2NO 2NO C Dopamine antagonists, Irreversible MAO-B selective inhibitor. Rasagiline D2 agonist. Cabergoline 1mg, 2mg, 4mg. White, (as mesilate) 1mg. White, round, flat, bevelled oval, concave scored tabs., engraved 7 on the left antihypertensives, anticoagulants, other drugs tab., marked with GIL and 1 underneath on one of breakline and 01, 02, or 03 resp. on the right of known to affect protein binding. A Pain, abdominal pain, GI disorders, side. 28, A92.96. it. 1mg-20, A79.80; 2mg-20, A92.87; 4mg-16, pyskinesia, hallucinations, somnolence. A86.67. S Idiopathic Parkinson’s disease as monotherapy (without levodopa) or as adjunct S Parkinson’s disease, as 2nd line therapy somnolence, rhinitis, dyspnoea, diplopia, cardiac valvulopathy (incl. regurgitation) and related therapy (with levodopa) in patients with end of where non-ergot compound inappropriate, as disorders (pericarditis, pericardial effusion). dose fluctuations. monotherapy, or as adjunctive treatment to P 1mg once daily with or without levodopa plus dopa-decarboxylase inhibitor. COMTESS Orion levodopa. P Initially 1mg once daily, increase with Q Under 18 years, not recommended. 0.5-1mg/day increments every week (initial weeks) 2 M O Cathecol-o-methyl transferase inhibitor. D Severe hepatic insufficiency. or bi-weekly to 2-3mg/day. Entacapone 200mg. Brown-orange oval film-ctd B Moderate hepatic impairment (avoid). D Hypersensitivity to ergot alkaloids. tab. marked Comtess one side. 100, A75.97. Mild hepatic insufficiency (caution). Pregnancy, History of pulmonary, pericardial and S As an adjunct to levodopa/benserazide lactation. retroperitoneal fibrotic disorders. Anatomical or levodopa/carbidopa in patients with Parkinson’s C Other MAOIs or pethidine (contra evidence of cardiac valvulopathy of any valve. disease and end-of-dose motor fluctuations, who within 14 days of rasagiline discontinuation). Pregnancy, lactation. cannot be stabilised on those combinations. Avoid fluvoxamine, fluoxetine (See SPC), B End-stage renal failure, patients on P 200mg taken with each dose of dextromethorphan, sympathomimetics (eg. nasal/ haemodialysis. Severe hepatic insufficiency. levodopa/dopa decarboxylase inhibitor. Max. dose oral decongestants or cold medications containing Respiratory disorders, CVD (or history of). 200mg ten times daily. See SPC. ephedrine or pseudoephedrine). Caution: SSRIs, Raynaud’s syndrome, peptic ulcer, GI bleeding, tricyclic, tetracylic antidepressants, potent CYP1A2 psychosis. Driving/using machines. Contains lactose. Q Not applicable. D Liver impairment, phaeochromocytoma. inhibitors (e.g. ciprofloxacin), smoking, C Avoid ergot alkaloids, macrolide Pregnancy, lactation. Previous history of entacapone. antibiotics and drugs with dopamine antagonist Neuroleptic Malignant Syndrome and/or nonA Monotherapy: Headache, flu syndrome, activity. malaise, neck pain, allergic reaction, fever, angina A Dyskinesia, hyperkinesia, hallucinations, traumatic rhabdomyolysis. B Rhabdomyolysis 2ndary to severe pectoris, dyspepsia, anorexia, leucopenia, confusion, dizziness, hypotension, symptomatic dyskinesias or Neuroleptic Malignant Syndrome arthralgia, arthritis, depression, vertigo, rhinitis, pleural effusion/fibrosis, nausea, vomiting, (NMS) reported. May aggravate levodopa-induced conjunctivitis, contact dermatitis, vesiculobullous dyspepsia, gastritis, decreased BP in minority. orthostatic hypotension. Withdraw slowly. Driving/ rash, skin carcinoma, urinary urgency. Adjunct CELANCE Lilly using machines. therapy: Dyskinesia, dystonia, abnormal dreams, C Non-selective MAOIs, TCADs, NA ataxia, abdominal and neck pain, falls, postural 2MO reuptake inhibitors, catechol-like drugs hypotension, GI disorders, anorexia, dry mouth, Dopamine agonist. Pergolide (mesilate) 50mcg, arthralgia, tenosynovitis, weight loss, rash. 250mcg, 1000mcg. Ivory, green or pink rectangular metabolised by COMT, iron preparations. scored tabs. marked LILLY and 4131, 4133 or 4135 A Dyskinesias, nausea, GI disorders, BETAFERON Bayer Schering discoloured urine. Slight decrease in Hb, resp. 50mcg-100, A41.48; 250mcg-100, A49.80; erythrocyte count and haematocrit. 2NT 1000mcg-100, A169.81.
D Natural or recombinant interferon beta, history of severe depression or suicidal tendencies, uncontrolled epilepsy. Pregnancy, lactation. B History of seizures or depression, severe hepatic or renal impairment, cardiac disease. Monitor blood chemistry, haematology and liver function tests. C Drugs metabolised by liver enzymes (e.g. antiepileptics and some antidepressants), caution. A Influenza-like syndrome, GI upset, arthralgia, insomnia, dizziness, anxiety, rash, inj. site reactions, hypersensitivity.
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.
Antiviral/immunoregulator. Interferon beta-1b 0.25mg/ml. Powder in vial plus pre-filled glass syringe of solvent containing 1.2ml sterile sodium chloride sln (0.54% w/v). 1 month’s supply-15 x 3ml. Price available on request. 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
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; 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
122
COPAXONE
sanofi-aventis
2NT Immunomodulator. Glatiramer acetate 20mg (equiv. 18mg glatiramer base). 28 pre-filled 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.
2
5
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Permitted
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Prohibited in specific sports
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3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
combinations of Parkinson medicinal products have not given satisfactory results. P Gel for continuous intestinal admin. 3 Acetylcholinesterase inhibitor. Donepezil (HCl) doses/day divided into the following. The morning 5mg, 10mg. White and yellow round biconvex dose: Usually 5-10ml (max. 15ml) admin. by pump. film-ctd tab marked D9EI on one side and 5 and Continuous maintenance dose: Range, 1-10ml/ 10 resp. on reverse. 5mg-28, A44.49, 10mg-28, hour; usually 2-6ml/hour. Extra bolus doses: A62.36. Normally 0.5-2.0ml as required. If the need for S Mild to moderate severe Alzheimer’s extra bolus doses q 5/day the maintenance dose dementia. should be increased. See SPC. P Initially 5mg once daily at bedtime. Q Not recommended. Increase if necessary to 10mg at bedtime after 1 D Narrow-angle glaucoma, severe liver/ month. Initiated and supervised by experienced renal insufficiency, severe HF, severe cardiac physician. Maintain as long as therapeutic benefit. arrhythmia, acute stroke. Lactation. Q Not recommended. B Not for drug-induced extrapyramidal DONECEPT Actavis D Pregnancy (unless clearly necessary), reactions. Caution: Severe cardiovascular or lactation. pulmonary disease; bronchial asthma, renal, 2NO B Supraventricular conduction hepatic or endocrine disease, or history of peptic, Acetylcholinesterase inhibitor. Donepezil (HCl) disturbances, history of GI ulceration, bladder ulcer disease or of convulsions, chronic wide-angle 5mg, 10mg. White and pale yellow, round, outflow obstruction, seizures, asthma, COPD, glaucoma (control IOP), abrupt dosage changes. biconvex film-ctd tabs marked DZ 5 and DZ 10 hepatic impairment. Contains lactose. Driving or History of MI. Monitor for mental changes, resp. 5mg-28, A47.43; 10mg-28, A68.53. using machines. depression with suicidal tendencies. Psychosis (or S Mild to moderate severe Alzheimer’s C Avoid cholinergics and anticholinergics. history of). General anaesthesia (patients must be dementia. Caution: Neuromuscular blockers, CYP3A4 inducers permitted to take fluids and medicinal products by P Initially 5mg once daily at bedtime. and inhibitors, CYP2D6 inhibitors (eg. fluoxetine), mouth). Evaluate hepatic, haematopoietic, Increase if necessary to 10mg at bedtime after 1 alcohol, anaesthetics. cardiovascular and renal function periodically. month. Initiated and supervised by experienced A Diarrhoea, muscle cramps, fatigue, Previous surgery in upper abdomen may lead to physician. Maintain as long as therapeutic benefit. nausea, vomiting and insomnia, headache. difficulty in performing gastrostomy or Q Not recommended. Common cold, anorexia, hallucinations, agitation, jejunostomy. Reduced ability to handle the system D Pregnancy, lactation. aggressive behaviour, syncope, dizziness, rash, can lead to complications (caregiver should assist). B May cause vagotonia, supraventricular pruritis, urinary incontinence, pain, accident. Worsening of bradykinesia may indicate an conduction disturbances, ulcers, bladder outflow obstruction in device. Pregnancy (unless clearly obstruction, seizures. Caution with asthma, COPD. DOZEPT Rowex necessary). Contains lactose. Driving or using machines. C Contra: Non-selective MAOIs and 2NO C Avoid cholinergics and anticholinergics. Acetylcholinesterase inhibitor. Donepezil HCl 5mg, selective MAO type A inhibitors. Caution: Caution: CYP3A4 inducers and inhibitors (see Antihypertensives, TCAs, anticholinergics, 10mg. Resp., white (diameter 7mm) or yellow Appendix I), CYP2D6 inhibitors (eg. fluoxetine), dopamine receptor antagonists, benzodiazepines, (diameter 9mm) film-ctd tabs. 10mg tabs have a neuromuscular blockers, b-blockers, alcohol, isoniazide, phenytoin, papaverine, selegiline, score line and can be divided into equal halves. anaesthesia. COMT inhibitors (tolcapone, entacapone), A A 5mg-28, 45.65; 10mg-28, 64.01. A GI disorders, headache. Common cold, amantadine, sympathicomimetics, iron, protein S Symptomatic treatment of mild to anorexia, hallucinations, agitation, aggressive rich diet. moderately severe Alzheimer’s dementia. behaviour, syncope, dizziness, insomnia, rash, A Anorexia, hallucinations, confusion, P Initially 5mg once daily at bedtime. pruritis, urinary incontinence, muscle cramps, nightmares, sleepiness, fatigue, sleeplessness, Increase if necessary to 10mg at bedtime after 1 fatigue, pain, accident. month. Initiated and supervised by an experienced depression, euphoria, dementia, psychotic episodes, feeling of stimulation, dyskinesias, DONELINN Helsinn Birex physician. Maintain as long as therapeutic benefit. choreatic movements and dystonia, ‘‘ON-OFF’’ D Hypersensitivity to piperidine 2NO episodes, dizziness, palpitations, irregular derivatives. Lactation, pregnancy (unless clearly heartbeat, orthostatic hypotension, syncope, Acetylcholinesterase inhibitor. Donepezil (HCl) necessary). nausea, vomiting, dry mouth, bitter taste. 5mg, 10mg. Resp. white or pale yellow, round, B Caution: Anaesthesia, cardiovascular biconvex film-ctd tabs, marked DZ5 or DZ10. 5mg- conditions (sick sinus syndrome, sinoatrial or EBIXA Lundbeck 28, A45.68; 10mg-28, A64.02. atrioventricular block), patients at risk of S Mild or moderate dementia in developing ulcers (monitor), asthma or obstructive 2 N O Alzheimer’s disease. pulmonary disease. May occur: Bladder outflow NMDA-receptor antagonist. Memantine (HCl) P Initially 5mg once daily at bedtime. If obstruction, seizures, exacerbation or induction of 10mg. White to off-white oblong film-ctd tab. extrapyramidal symptoms. Driving/operating necessary increase to 10mg (max) after 1 month. scored both sides. 28, A50.40; 56, A100.80. machines. Contains lactose. Maintain as long as therapeutic benefit exists. S Moderate to severe Alzheimer’s disease. C CYP3A4 inducers and inhibitors (see Hepatic impairment: Mild to moderate, adjust P Initially, 5mg daily (week 1); 2nd week, according to individual tolerance; severe, no data. Appendix I), CYP2D6 inhibitors (e.g. fluoxetine), 10mg daily; 3rd week, 15mg daily. From week 4 succinylcholine, other neuro-muscular blocking Q Not recommended. onwards, 20mg once daily. Maintenance dose: agents, cholinergic agonists, b-blocking agents. D Hypersensitivity to piperidine 20mg once daily (max dose). Moderate renal A Common cold, anorexia, hallucinations, impairment: 10mg/day, can be increased to 20mg derivatives. Pregnancy, lactation. agitation, aggressive behaviour, syncope, dizziness, using standard titration if well tolerated after 7 B Caution: Anaesthesia, cardiovascular insomnia, GI disorders, rash, pruritis, muscle conditions, patients at risk of ulcers (monitor), days. Severe renal impairment: 10mg/day. asthma or COPD. May occur: Urethral obstruction, cramps, urinary incontinence, headache, fatigue, Q Under 18 yrs, not recommended. pain, accident. 2NO seizures, exacerbation or induction of extrapyramidal symptoms. Driving/using machines. ALSO EBIXA ORAL DROPS Memantine (HCl) 10mg/ DUODOPA Solvay g. Soln. 50g, A90.00; 100g, A180.00. Contains lactose. 2M C Caution: CYP3A4 inducers and P Initially, 10 drops (5mg) daily (week 1); inhibitors, alcohol, anticholinergics, CYP2D6 Dopamine precursor/dopa decarboxylase inhibitor. 2nd week, 20 drops (10mg) daily; 3rd week, 30 inhibitors, succinylcholine, other neuro-muscular Levodopa 20mg, carbidopa (as monohydrate) 5mg/ drops (15mg) daily. From week 4 onwards: 40 blocking agents, cholinergic agonists, b-blockers. ml. White to slightly yellow intestinal gel. 100ml-7, drops (20mg) once daily. Maintenance dose: 40 A Cold, anorexia, hallucinations, agitation, price available on request. drops (20mg) once daily max. Moderate renal aggression, syncope, dizziness, sleep disturbances, S Treatment of advanced levodopaimpairment: 20 drops (10mg) daily, can be GI disorders, rash, pruritus, muscle spasms, responsive Parkinson’s disease with severe motor increased to 40 drops (20mg) using standard fluctuations and hyper-/dyskinesia when available titration if well tolerated after 7 days. Severe renal incontinence, headache, fatigue, pain, accident. 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).
124
DONESYN
Clonmel
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
3.7 PARKINSON’S, ALZHEIMER’S
AND
MS
CNS
(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.
alone or in combination with levodopa. Moderate to severe idiopathic Restless Legs Syndrome (RLS). P PD: Initially 0.088mg base (0.125mg salt) three times daily, doubling the dose every 5-7 days to 0.36mg base (0.5mg salt) three times daily. If necessary, increase further by 0.54mg base (0.75mg salt) daily at weekly intervals to achieve optimal effect; max. 3.3mg base (4.5mg salt) daily. When co-prescribed, reduce dose of levodopa while titrating pramipexole. RLS: Initially 0.088mg base (0.125mg salt) once daily 2-3 hrs before KEMADRIN GSK bedtime; may be increased every 4-7 days to max. 0.54mg base (0.75mg salt) per day. 2MO Q Under 18 years, not recommended. Anticholinergic. Procyclidine (HCl) 5mg. White 2 MO scored tab. marked WELLCOME S3A. 100, A6.75. ELDEPRYL Orion S Parkinsonism, particularly drug-induced. ALSO MIRAPEXIN PROLONGED RELEASE Pramipexole (dihydrochloride monohydrate) 0MO P Initially 2.5mg three times daily after meals increasing at intervals of 2 or 3 days by 2.5- 0.26mg, 0.52mg, 1.05mg, 2.1mg, 3.15mg. White to Monoamine oxidase-B inhibitor. Selegiline (HCl) off white tablets embossed with Boehringer 5mg daily; usual max. 30mg daily. 5mg. White scored tab. 100, A68.05. Ingelheim company symbol on one side and either Q Not recommended. S Parkinson’s disease or symptomatic P1, P2, P3, P4 or P5 on the other side. 0.26mg-30, D Tardive dyskinesia. parkinsonism, alone to delay the need for B GI obstruction. Narrow angle glaucoma. A28.28; 0.52mg-30, A56.57; 1.05mg-30, A113.14; levodopa or in conjunction with levodopa Prostatic hypertrophy. Cardiac disorders. Withdraw 2.1mg-30, A226.28, 3.15mg-30, A339.41. particularly in patients on levodopa who develop S Idiopathic Parkinson’s disease, alone slowly. on-off symptoms or other dyskinesias. (without levodopa) or in combination with C Phenothiazines, antihistamines, P Initially 1 increasing to 2 if necessary. levodopa. antidepressants, amantadine, butyrophenones. Q Not applicable. A Anticholinergic effects. Dizziness, mental P Initial titration: Week 1: 0.26mg base D Pregnancy, lactation. (0.375mg salt) daily; Week 2: 0.52mg base (0.75mg confusion, impaired cognition and memory, B Peptic/duodenal ulcer, labile disorientation, anxiety, agitation, hallucinations in salt) daily; Week 3: 1.05mg base (1.5mg salt) daily; hypertension, cardiac arrhythmias, severe angina if necessary, increase by 0.52mg base (0.75mg salt) high doses. pectoris, severe liver or kidney dysfunction, daily up to 3.15mg base (4.5mg salt) max. Patients psychosis. already taking Mirapexin tab. can be switched to MADOPAR Roche C Non-specific MAOIs (contra). Avoid prolonged-release tab. at same daily dose. fluoxetine, sertraline, paroxetine, venlafaxine, 2MO Maintenance: 0.26mg-3.15mg base (0.375mgpethidine. Caution: Moclobemide, TCAs, oral Dopamine precursor/dopa decarboxylase inhibitor. 4.5mg salt); Withdraw gradually. Renal contraceptives. ’62.5’: levodopa 50mg, benserazide (HCl) 12.5mg. impairment: ccq50ml/min, no dose adjustment. A Postural hypotension, involuntary ’125’: levodopa 100mg, benserazide (HCl) 25mg. 30QccQ50ml/min: Initially 0.26mg every other movements , cardiac arrhythmias, vertigo (reduce ’250’: levodopa 200mg, benserazide (HCl) 50mg. day; increasing by 0.26mg base (0.375mg salt) if levodopa dose). Dry mouth, transient ALAT ’62.5’ and ’125’, white scored dispersible tabs. necessary at weekly intervals up to max 1.57mg increase, sleeping disorders. marked with strength. ’250’, brown/blue hard cap. base (2.25mg salt); ccQ30ml/min, not All marked ROCHE. ’62.5’-100,A9.61; ’125’-100, recommended. EXELON Novartis A 17.05; ’250’-100, A26.04. Q Under 18 years, not recommended. 2N S Idiopathic post-encephalitic D Pregnancy (unless clearly necessary), Parkinsonism. Acetylcholinesterase inhibitor. Rivastigmine (as lactation. P Patients not receiving levodopa, initially hydrogen tartrate) 1.5mg, 3mg, 4.5mg, 6mg. B Caution: Severe CVD, renal impairment. 1 x ’62.5’ three or four times daily after meals Yellow, orange, red or orange/red caps. marked Inform patients that hallucinations can occur. In increasing by 1 x ’125’ daily once or twice weekly. with cap. name and strength. 1.5mg-28, A36.33; combination with levodopa, dyskinesia can occur Usual maintenance, 4-8 x ’125’ daily in divided 1.5mg-56, A72.65; 3mg, 4.5mg and 6mg-28; during Mirapexin initial titration; decrease A37.33; 3mg, 4.5mg and 6mg-56, A74.66. doses. See SPC. Not recommended for patients levodopa dose if occurs. Pathological gambling, under 25 years. 2NO increased libido and hypersexuality reported. Only R Initially 1 x ’62.5’ once or twice daily ALSO EXELON ORAL SOLUTION Rivastigmine (as treat patients with psychotic disorders if benefits hydrogen tartrate) 2mg/ml. Soln. with oral dosing increasing by 1 x ’62.5’ every third or fourth day. outweigh risks. Ophthalmologic monitoring Q Not recommended. A syringe. 120ml, 149.83. recommended at regular intervals or if vision D Patients Q 25 yrs, severe psychoses, S Symptomatic treatment of mild to abnormalities occur. Monitor BP. Neuroleptic narrow angle glaucoma, history of malignant moderately severe Alzheimer’s dementia or malignant syndrome reported with abrupt melanoma. Pregnancy, lactation. dementia associated with idiopathic Parkinson’s withdrawal. Driving/operating machinery B Cardiovascular, hepatic, renal, disease. (somnolence and sudden sleep onset may occur). pulmonary or endocrine disease. Peptic ulceration. C Avoid antipsychotics. Caution: Drugs P Initially 1.5mg morning and evening with meals; may be increased by 1.5mg twice daily Psychiatric disturbances. Wide angle glaucoma. inhibiting or eliminated by renal tubular secretion Osteomalacia. Monitor blood values and hepatic, at min. 2 week intervals. Maintain patient on (eg. cimetidine, amantadine, mexiletine), sedating renal and cardiovascular function. highest tolerated dose; up to max. 6mg twice drugs, alcohol. Levodopa and other antiC Drugs affecting central amines. MAOIs, daily. Oral soln. and caps. may be interchanged at parkinsonian products, caution during Mirapexin antihypertensives and sympathomimetics. equal doses. titration. A Nausea, vomitimg, anorexia. Postural Q Not applicable. A Abnormal dreams, behavioural hypotension. Involuntary movements. Cardiac and symptoms of impulse control disorders and 2NO compulsions, confusion, hallucinations, insomnia, ALSO EXELON PATCH Rivastigmine 4.6mg, 9.5mg CNS disturbances. Urine discolouration. restlessness, dizziness, dyskinesia, somnolence, per 24 hours. Transdermal patches. Both strengthsMIRAPEXIN Boehringer Ing. amnesia, headache, visual disturbance including 30, A102.61. vision blurred and visual acuity reduced, 2MO S Symptomatic treatment of mild to hypotension, nausea, constipation, vomiting, Selective dopamine agonist. Pramipexole (mg moderately severe Alzheimer’s dementia. P Initially 4.6mg/24 h. After min. 4 weeks 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; should be increased to 9.5mg/24 h (maintenance NEUPRO UCB others scores on both sides. 0.088mg-30, A9.16; dose). Switching from caps or soln, see SPC. 2MO 0.18mg-100, A60.86; 0.7mg-100, A243.98. Q Not applicable. Dopamine agonist. Rotigotine 1mg, 2mg, 3mg, D Severe liver impairment. Pregnancy S Idiopathic Parkinson’s disease (PD), impairment: 20 drops (10mg) daily. Q Under 18 yrs, not recommended. B Severe hepatic impairment. Epilepsy. Conditions in which urine pH is elevated. MI, CHF, uncontrolled hypertension (closely supervise). Contains lactose (tablets) / sorbitol (drops). C Amantadine, ketamine, dextromethorphan, L-dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, dantrolene, baclofen, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide A Dizziness, constipation, hypertension, headache, somnolence.
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Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
3.7 PARKINSON’S, ALZHEIMER’S 4mg, 6mg, 8mg per 24 hrs. Transdermal patch. 1mg/24h-28, A101.31; 2mg/24h-28, A104.56; 3mg/ 24h -28, A138.01; 4mg/24h-28, A121.61; 6mg/24h28, A140.63; 8mg/24h-28, A158.94. S Signs and symptoms of early-stage idiopathic Parkinson’s disease as monotherapy (i.e. without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages (end of dose or ’on-off’ fluctuations). Moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. P Apply patch daily and replace every 24 hrs. PD: Early stage: Initially, 2mg/24h, then increase in weekly increments of 2mg/24h to max. 8mg/24h. Advanced stage: Initially, 4mg/24h, then increase in weekly increments of 2mg/24h to max. 16mg/24h. For doses q 8mg/24h use multiple patches. Discontinue gradually in decrements of 2mg/24h every other day. RLS: Initially 1mg/24h; then increase in weekly increments of 1mg/24h, up to max. 3mg/24h. Reconsider treatment duration every 6 months. Discontinue gradually in 1mg/24h decrements daily every other day. Q Children and adolescents, not recommended. D MRI or cardioversion. Pregnancy, lactation. B Monitor BP esp. at start of treatment. May cause somnolence/sudden sleep onset; consider dose reduction/discontinuation if occurs. Compulsive disorders have been reported. May occur: Hallucinations, fibrotic complications. Monitor eyes regularly and if vision abnormalities occur. Do not apply external heat to patch area. Rotate appl. site (do not use same site within 14 days). Assess if persistent appl. site reactions occur. Discontinue if generalised skin reaction occurs. Severe hepatic impairment. Unexpected accumulation of rotigotine may occur at acute worsening of renal function. Withdraw gradually. Driving / using machinery. C Avoid dopamine antagonists. Caution: CNS depressants, alcohol. A PD: Anorexia, hallucination, anxiety, dizziness, dyskinesia, lethargia, orthostatic hypotension, cough, hiccup, hyperhydrosis, erythema, peripheral oedema, asthenic conditions, hepatic enzyme increased. RLS: Fatigue, irritability, hypersensitivity, sleep disorder, sexual desire disorder, hypertension. Both indications: Sleep attacks, abnormal dreams, insomnia, somnolence, headache, GI disorders, pruritus, appl. site reactions.
AND
MS
PARLODEL
CNS 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.
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.
REMINYL XL
Shire
2NO Antidementia drug. Galantamine (hydrobromide) 8mg, 16mg, 24mg. White, pink and caramel opaque hard caps. marked G8, G16 and G24 resp. 8mg-28, A64.97; 16mg-28, A80.69; 24mg-28, A99.72. S Symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. P Initially 8mg once-daily in the morning preferably with food for 4 weeks. Initial maintenance dose, 16mg/day for at least 4 weeks. Consider increase to maintenance dose of 24mg/ day. Moderate hepatic impairment: Initially 8mg once every other day for 1 week; thereafter 8mg once-daily for 4 weeks; max. 16mg daily. Q Not recommended.
2NO
ALSO REMINYL Galantamine (hydrobromide) 8mg, 12mg. Off-white, pink and orange-brown tabs. marked JANSSEN one side and G8 or G12 on reverse. 8mg-56, A80.69; 12mg-56, A99.72; 12mg168, A299.17. P Starting dose 4mg twice a day morning and evening for four weeks. Initial maintenance dose 8mg twice a day for at least 4 weeks; consider increase to maintenance dose of 12mg twice a day after assessment. If this increase REBIF Merck Serono inefficient or not tolerated, reduce dose to 16mg 2NT daily. Continue maintenance therapy as long as Immunomodulator. Interferon beta-1a, 8.8mcg/ therapeutic benefit exists. Moderate hepatic 0.2ml, 22mcg/0.5ml, 44mcg/0.5ml. Clear to impairment: Initially 4mg once daily in the opalescent soln. in pre-filled syringe or cartridge. morning for 1 week followed by 4mg twice daily Syringes: 8.8mcg-6 and 22mcg-6 (initiation pack), for 4 weeks; max. 8mg twice daily. A1092.57; 22mcg-12, A1042.19; 44mcg-12, Q Not recommended. A1428.68. Cartridges: Initiation Pack-2, A714.42; 2NO A A 22mcg -4, 1042.3; 44mcg -4, 1428.84. ALSO REMINYL ORAL SOLUTION Galantamine S Treatment of relapsing multiple 4mg/ml. 100ml, A91.67. sclerosis. P As per Reminyl. P Weeks 1 and 2, 8.8mcg by SC inj. 3 D Severe hepatic or severe renal times weekly. Weeks 3 and 4, 22mcg 3 times impairment. Lactation. weekly. From week 5 onwards, 44mcg. B Sick sinus syndrome, other Q Under 12 years, not recommended. 12supraventricular cardiac conduction disturbances, NITOMAN Cambridge 16 years, 22mcg 3 times weekly. history of ulcer disease, history of severe asthma D Current severe depression and/or or obstructive pulmonary disease, anaesthesia. 2MO suicidal ideation. Pregnancy, lactation. Urinary outflow obstruction or patients recovering Benzoquinolizine. Tetrabenazine 25mg. Yellowish- B Caution: Previous or current depressive from bladder surgery (not recommended). buff, circular, bevel-edged scored tab. marked disorders, antecedents of suicidal ideation, history Pregnancy. CL25. 112, A155.17. of seizures, treatment with anti-epileptics C Cholinomimetics (not recommended). S Control of disorders of movement (particularly uncontrolled epilepsy), severe renal/ Caution: Potent inhibitors of CYP2D6 (eg. associated with organic disease of the CNS, such as hepatic failure, severe myelosuppression, cardiac quinidine, paroxetine, fluoxetine) or CYP3A4 (eg. Huntington’s chorea, hemiballismus and senile disease (monitor during therapy initiation). To heart rate chorea. prevent injection site necrosis, rotate injection site ketoconazole, ritonavir), drugs reducing (eg. digoxin, b-blockers, certain Ca++-channel P Initially, v-1 three time daily; can be and use aseptic technique. Increases in hepatic blockers, amiodarone), drugs likely to cause increased by 25mg a day every three or four days transaminases (particularly ALT) may occur, torsades de pointes. up to 200mg daily or until limit of tolerance. If no monitor prior to treatment and at months 1, 3, 6 A Rhinitis, anorexia, weight decrease, and periodically thereafter; if ALTq5xULN improvement at max. dose in 7 days, benefit is insomnia, confusion, depression, dizziness, consider dose reduction. May cause severe liver unlikely. somnolence, tremor, GI disorders, dyspepsia, UTIs, injury and dysfunction (discontinue). Prior to inj. B Pregnancy, lactation (avoid). Driving/ fever, headache, malaise, fatigue, fall, injury. and for 24 hrs after, an antipyretic analgesic is using machines. Neuroleptic malignant syndrome advised to decrease flu-like symptoms. Evaluate (discontinue if occurs). Contains lactose. REQUIP GSK patients at least every 2nd year. Driving/operating C Contra: Reserpine, MAOIs (within 2 2MO machinery. weeks). Caution: Levodopa. C Drugs with a narrow therapeutic index A Drowsiness, hypotension, depression. Dopamine agonist. Ropinirole (as HCl) 0.25mg,
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CNS
PARKINSON’S, ALZHEIMER’S
AND
MS 3.7
lactation. B Severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or Dopamine precursor/dopa decarboxylase inhibitor. endocrine disease, history of peptic ulcer or of Carbidopa/levodopa 12.5mg/50mg, 10mg/100mg, convulsions, past or current psychosis. History of 25mg/100mg (’Plus’), 25mg/250mg. Yellow, dapple- MI (monitor cardiac function). Monitor mental blue, yellow, light-dapple-blue, oval scored tabs changes, depression with suicidal tendencies, and marked 520, 647, 650, 654 resp. Scoreline only to other serious antisocial behaviour. Past or current facilitate breaking, not for dosing. 12.5/50-90, psychosis. Wide-angle glaucoma (control intraA8.60; 10/100-90, A8.99; ’Plus’-90, A13.27; 25/250- ocular pressure). May induce orthostatic 90, A18.81. hypotension. Periodic evaluation of hepatic, S Idiopathic, post-encephalitic and haematopoietic, cardiovascular and renal function 2MO arteriosclerotic Parkinsonism. is recommended during extended therapy. Driving ALSO REQUIP MODUTAB Ropinirole 2mg, 4mg, P Patients not receiving levodopa: Plus, or operating machines. Avoid abrupt dosage 8mg. Pink, light brown or red resp. cap-shaped, 12.5/50, 10/100; initially 1 tab. three (Plus) to four reduction. Monitor for weight loss. Pathological film-ctd, prolonged-release tab., marked GS one times daily increased by 1 tab. every day or every gambling and increased libido have been side and either 3V2, WXG or 5CC resp. on the other day up to max. 8 daily. 25/250; initially v reported. Not for treatment of drug-induced other. 2mg-84, A106; 4mg-84, A192.33; 8mg-84, tab. once or twice daily; if necessary, add v tab. extrapyramidal reactions. Contains sucrose. A375.78. every day or every other day. See SPC. C Caution: Antihypertensives, S Parkinson’s disease, as initial antidepressants, D2 receptor antagonists, monotherapy in order to delay the introduction of Q Under 18 years, not recommended. 2MO phenytoin, iron, papaverine, warfarin, high l-dopa, or in combination with l-dopa when the protein diet. ALSO SINEMET CR PROLONGED RELEASE effect of l-dopa wears off or fluctuates. A Dyskinesias, nausea, diarrhoea, mental Levodopa 200mg, carbidopa (as monohydrate) P Week 1: 2mg once daily. Week 2: 4mg changes (paranoid ideation, psychotic episodes, 50mg. Mottled peach oval cont.-release tab. once daily. If sufficient symptomatic control not depression, with or without development of marked DPP 521. 60, A26.48. achieved or maintained, increase to 8mg/day by suicidal tendencies,cognitive dysfunction), 2mg weekly or longer intervals. May be increased 2 M O Parkinsonism aggravated, dizziness, dystonia, to max 24mg/day if 8mg/day still not sufficient. ALSO HALF SINEMET CR PROLONGED RELEASE hyperkinesia, GI upset, urine discolouration, See SPC when switching from immediate-release Levodopa 100mg, carbidopa (as monohydrate) fatigue, increased sweating, falls, insomnia, ropinirole tablets. As adjunct to l-dopa, l-dopa 25mg. Pink oval cont.-release tab. marked DPP hallucinations, confusion, paroniria. dose may be reduced gradually by approx. 30%. and 601. 60, A22.36. R Consider slower titration during P Over 18 years, patients not receiving TASMAR Meda treatment initiation. levodopa, initially 1 CR tab. twice daily. Titrate Q Under 18 years, not recommended. according to response. Patients receiving 2NO D Severe renal or hepatic impairment. levodopa, see SPC. COMT inhibitor. Tolcapone 100mg. Light yellow, Pregnancy, lactation. Q Not recommended hexagonal, biconvex, film-ctd tab. marked B Severe CVD in particular coronary D Narrow angle glaucoma, history of TASMAR and 100. 100, A116.17. insufficiency. Monitor BP, particularly at start of malignant melanoma. Lactation. S In combination with levodopa/ treatment (risk of postural hypotension). B Cardiovascular, hepatic, renal, benserazide or levodopa/carbidopa for use in Psychiatric or psychotic disorders (only if benefit pulmonary or endocrine disease. Psychoses. Peptic patients with levodopa-responsive idiopathic outweighs risk). Sudden onset of sleep may occur ulceration. Wide angle glaucoma. Pregnancy. Parkinson’s disease and motor fluctuations, who (warn patients). Driving/ operating machines. Monitor blood values and hepatic, renal and failed to respond to or are intolerant of other Impulse control disorders may occur. Withdraw cardiovascular function. COMT inhibitors. gradually over 1 week. Contains lactose. Contains C Drugs affecting central amines. MAOIs. P 100mg three times daily. Take 1st dose sunset yellow (4mg-modutab only). Antihypertensives and sympathomimetics. with 1st levodopa dose, and subsequent doses 6 C Avoid: Neuroleptics and other centrally A Nausea, vomiting, anorexia. Postural and 12 hrs later. May be exceptionally increased active dopamine antagonists (sulpiride, hypotension. Involuntary movements. Cardiac and to 200mg three times daily if benefit outweighs metoclopramide). Adjust ropinirole dose: CNS disturbances. Urine discolouration. hepatic risk. Discontinue if substantial benefits are Concomitant CYP1A2 inhibitors (ciprofloxacin, not seen within 3 weeks. STALEVO Orion Q Not recommended. enoxacin, fluvoxamine), if HRT is introduced or stopped during treatment or if patients start or D Because of risk of potentially fatal, 2MO stop smoking. Dopamine precursor/dopa decarboxylase inhibitor/ acute liver injury, should not be considered as A Somnolence, syncope, nausea, COMT inhibitor. Levodopa/carbidopa/entacapone: first-line adjunct therapy. Liver disease or hallucinations, dizziness (incl. vertigo), confusion increased liver enzymes, severe dyskinesia, history 50/12.5/200mg, 75/18.75/200mg, 100/25/200mg, (in adjunct therapy), vomiting, heartburn, of Neuroleptic Malignant Syndrome Symptom 125/31.25/200mg, 150/37.5/200mg, 200/50/200mg. abdominal pain, constipation, oedema peripheral. Film-ctd tabs. Resp., round greyish/brownish-red, Complex (NMS) and /or rhabdomyolysis or hyperthermia, phaeochromocytoma. Pregnancy, oval light brownish red, oval greyish/brownish-red, RILUTEK sanofi-aventis oval light brownish red, ellipse-shaped greyish/ lactation. B Check liver function before treatment 2NT brownish-red and oval dark brownish-red; all Antiglutamate. Riluzole 50mg. White cap.-shaped marked LCE followed with levodopa strength. All and every 2 weeks for 1st year, every 4 weeks for next 6 months and every 8 weeks thereafter. A A strengths-100, 103.00. film-ctd tab. marked RPR 202. 56, 335.21. Changes in dose should be preceded by liver S Amyotrophic lateral sclerosis (motor S Parkinson’s disease and end-of-dose enzyme testing and then monitoring to commence neurone disease). motor fluctuations not stabilised on levodopa/ following sequence above. Discontinued if ALT P 50mg every 12 hrs. dopa decarboxylase inhibitor treatment. and/or ASTqULN or if signs of hepatic failure. Q Not recommended. P Adjust dose as required. Max: 10 tabs. Severe renal impairment. Contains lactose. D Hepatic disease or baseline transaminase daily for all strengths except 200/50/200 (max 7 C Consider levodopa dose reduction. Non q 3x ULN. Pregnancy, lactation. tabs.). Hepatic impairment, may need dose selective MAOIs (contraindicated). Caution: B Initiate treatment under specialist reduction. See SPC. Selective MAO-B inhibitors, benserazide, warfarin, supervision. Risk of hepatitis: monitor ALT before Q Under 18 years, not recommended. potent NA uptake inhibitors. and during treatment, discontinue if 5x ULN. D Severe hepatic impairment, A GI disorders, dyskinesia, syncope, Renal impairment. Neutropenia. pheochromocytoma, narrow-angle glaucoma, orthostatic complains, sleep disorders, somnolence, C Metabolised via CYP 1A2. previous history of Neuroleptic Malignant hallucination. A Abnormal liver function tests, GI Syndrome (NMS) and/or non-traumatic disorders, asthenia, pain, headache, dizziness, rhabdomyolysis. Non-selective MAOIs (e.g. Biogen tachycardia, somnolence, oral paraesthesia, phenelzine, tranylcypromine). Concomitant use of TYSABRI neutropenia. selective MAO-A and MAO-B inhibitors. Pregnancy, 2 J 1mg, 2mg, 5mg. White, green, pink and blue pentagonal film-ctd tabs. 0.25mg-210, A43.52; 1mg-84, A51.29; 2mg-84, A102.55; 5mg-84, A205.11. P Week 1: 0.25mg three times daily with meals. Week 2: 0.5mg three times daily. Week 3: 0.75mg three times daily. Week 4: 1mg three times daily. If necessary, continue to titrate in weekly increments of up to 3mg daily. Max. 24mg daily. As adjunct to l-dopa, l-dopa dose may be reduced gradually by around 20%.
SINEMET
MSD
2MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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NARCOLEPSY
Selective adhesion-molecule inhibitor. Natalizumab 20mg/ml. Concentrate for soln for inf. S Single disease modifying therapy in highly active relapsing remitting multiple sclerosis (MS) for patients with high disease activity despite treatment with a b-interferon and patients with rapidly evolving severe relapsing remitting MS. P 300mg by iv. inf. once every 4 weeks. Admin. over 1 hour, monitor patients during inf. and for up to 1 hour after. Reconsider continued therapy if no evidence of therapeutic benefit beyond 6 months. Q Under 18 years, contraindicated. D Progressive Multifocal Leukoencephalopathy (PML). Patients with increased risk for opportunistic infections, including immunocompromised patients. Known active malignancies (except cutaneous basal cell carcinoma). Children and adolescents. Pregnancy (unless clearly necessary), lactation. B Risk of PML. Before initiation recent MRI (within 3 mths) should be available and monitor patients regularly thereafter for neurological signs/symptoms of PML. Other opportunistic infections may occur. If either of these conditions suspected discontinue and only resume when excluded. Risk of hypersensitivity reactions (including serious systemic reactions); discontinue if occur. Inform patients of risks involved and give patients the special alert card. Pharmacodynamic effects last for 12 weeks following the last dose. Antibodies against natalizumab may develop. C Contra: b-interferons, glatiramer acetate, immunosuppressive and antineoplastic therapies. A UTIs, nasopharyngitis, urticaria, headache, dizziness, vomiting, nausea, arthralgia, rigors, pyrexia, fatigue.
for tics. do not use to prevent or treat normal fatigue states. Care with withdrawal after chronic use. May lower seizure threshold, discontinue if seizures. Monitor for emergence or worsening of aggressive behaviour. FBC, differential and platelet counts advised during prolonged use. Visual disturbances may occur. Monitor long-term patients for weight and/or height. Effective contraception required in females post-menarche. Contains lactose. C Contra: MAOIs. Caution: Vasopressor agents, coumarin anticoagulants, anticonvulsants (e.g. Phenobarbital, phenytoin, primidone), some antidepressans (tricyclics, SSRIs). Halogenated anaesthetics. Avoid alcohol. A Nasopharyngitis, aggression, anxiety, affect lability, tic, insomnia, headache, dizziness, cough, pharyngolaryngeal pain, GI disorders, irritability, pyrexia, decreased weight.
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.
PROVIGIL
Cephalon
0NO
Non-amphetamine wake promoter. Modafinil 100mg, 200mg. White to off-white tabs. debossed with 100 or 200 on one side. 100mg-30, A75.55; 200mg-30, A148.16. S Excessive sleepiness associated with chronic pathological conditions incl. narcolepsy, obstructive sleep apnoea/hypopnoea syndrome and moderate/severe chronic shift work sleep disorder. P Obstructive sleep apnoea/Narcolepsy: 200mg-400mg daily in two divided doses (morning EQUASYM Shire and noon), or as a single dose in the morning. 0LO Shift work sleep disorder: 200mg daily as single CNS stimulant. Methylphenidate (HCl) 5mg, 10mg, dose 1 hour prior to shift. 20mg. Tab. with breakline, with Medeva and R Over 65 years, initially 100mg daily. strength embossed on one side. 5mg-30, A3.50; Max. 400mg daily. 10mg-30, A6.39; 20mg-30, A12.77. Q Not recommended. 0LO D Pregnancy, lactation, uncontrolled ALSO EQUASYM XL Methylphenidate (HCl) 10mg, hypertension, or arrhythmia. 20mg, 30mg. Modified release opaque caps. Dark B Monitor BP and heart rate in hypertensive patients. History of LV hypertrophy green/white, blue/white, reddish-brown/white or ischaemic ECG changes, chest pain, arrhythmias resp. marked with Celltech 574, Celltech 575 or Celltech 576 on cap and 10mg, 20mg or 30mg on or other significant manifestations of mitral valve A A prolapse in association with CNS stimulant use. body. 10mg-30, 31.92; 20mg-30, 38.28; 30mgC Oral contraceptives, TCADs, 30, A44.67. anticonvulsants, warfarin. S Attention-deficit hyperactivity disorder A Nervousness, anxiety, headache, where remedial measures prove insufficient. insomnia, abdominal pain, nausea, dry mouth, Q Over 6 years: Initially, 5mg once or tachycardia, palpitation, asthenia, chest pain, twice daily, increasing if necessary by weekly blurred vision, abnormal liver function tests. increments of 5-10mg in daily dose. Admin daily dose of Equasym in divided doses. 10mg once 3.8 ADHD, NARCOLEPSY RITALIN Novartis daily may be used in place of Equasym 5mg twice 0LO CONCERTA XL Janssen-Cilag daily from the beginning of treatment where appropriate. Patients established on an immediate CNS stimulant. Methylphenidate (HCl) 10mg. 0LNO release methylphenidate may be switched to White, circular, flat scored tabs. marked CG one CNS stimulant. Methylphenidate (HCl) 18mg, equivalent daily dose of Equasym XL. Max: 60mg side, AB on reverse. 30, A5.40. 27mg, 36mg. 18mg-30, A37.43; 27mg-30, A45.06; daily. Swallow cap. whole with liquid, or open S Attention-deficit hyperactivity disorder 36mg-30, A50.94. cap. and swallow contents immediately after where remedial measures prove insufficient. S Attention Deficit Hyperactivity Disorder sprinkling on soft food, followed by a drink. P Not applicable. (ADHD) when remedial measures alone Discontinue periodically to assess child’s condition. Q Over 6 years: Initially, 5mg once or insufficient. Under 6 years, not indicated. twice daily, increasing if necessary by weekly P Not applicable. D Marked anxiety, agitation or tension. increments of 5-10mg in daily dose. Max: 40mg Q Under 6 years, not recommended; over Current or history of drug dependence, daily. Administer total daily dose in divided doses. 6 years, dosage should be individualised. Once alcoholism, severe depression, schizophrenic Discontinue periodically to assess child’s condition. daily in the morning, increasing weekly by 18mg symptoms, psychopathological personality Under 6 years, not indicated. to max. 54mg daily. New patients, limited structure, aggression, or suicidal tendency. Heart 0LO experience, start 18mg daily. Patients taking failure, MI, severe hypertension, hyperthyroidism, ALSO RITALIN LA Methylphenidate (HCl) 20mg, methylphenidate 3 times daily formulations: severe angina pectoris, cardiac arrhythmia, 30mg, 40mg; prolonged-release. White to off18mg 3 x 5mg; 36mg 3 x 10mg; 54mg 3 x glaucoma, thyrotoxicosis. white beads in white, yellow or light brown 15mg. Swallow whole with liquid. B Use in psychotic children. Can lead to opaque hard gelatin cap. with imprint R20, R30, D Marked anxiety and tension; glaucoma; marked tolerance, psychological dependence. R40 (body) resp. and NVR (cap). 20mg-30, A33.59; family history or diagnosis of Tourette’s syndrome; Monitor: Growth, BP, long-term use. Caution: in combination with non-selective irreversible Anorexia, emotionally unstable patients, epileptics, 30mg-30, A45.95; 40mg-A57.03. MAOIs (and within 14 days of their P Not applicable. withdrawal. May exacerbate tics and Tourette’s discontinuation); hyperthyroidism; severe angina Q 6 years and over: Once daily in syndrome. Contains sucrose. Driving or using pectoris; cardiac arrhythmias; severe hypertension; machinery. Pregnancy (unless clearly necessary), morning, with daily dose similar to short-acting severe depression, anorexia nervosa, psychotic methylphenidate daily dose (cf. Ritalin tabs. for lactation. symptoms or suicidal tendency; known drug initial dose). Max. daily dose: 40mg. Swallow as C Contra: MAOIs (or within 2 weeks). dependence or alcoholism. Pregnancy, lactation. whole cap. or sprinkle entire cap. content on Alcohol (avoid). Reduce dosage: Coumarin B Not recommended: Known structural anticoagulants, some anticonvulsants, TCAs, SSRIs. food. Under 6 years, not recommended. cardiac abnormalities, pre-existing severe GI D Anxiety, agitation or tension. Motor tics Caution: Vasopressor agents, clonidine or other narrowing (pathologic or iatrogenic), dysphagia, in patient or sibblings, family history or diagnosis centrally acting a-2 agonists, haloperidol, significant difficulty in swallowing tabs. Caution: of Tourette’s syndrome. Hyperthyroidism, severe thioridazine, guanethidine. Halogenated Hypertension (monitor BP), underlying medical angina pectoris, cardiac arrhythmias, glaucoma, anaesthetics. conditions that might be compromised by BP and A Nervousness, insomnia, decreased thyrotoxicosis. Lactation, pregnancy. appetite, arrhythmia, palpitations, tachycardia, heart rate increases, psychotic patients. Evaluate B History of drug dependance, epilepsy.
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Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA 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: Coumarin anticoagulants, anticonvulsants (phenobarbitone, phenytoin, primidone), phenylbutazone, tricyclic antidepressants. Caution: Pressor agents, MAOIs. Guanethidine (reduce antihypertensive effect). A Slight growth retardation. Transient decreased appetite, nervousness, insomnia, headache, dizziness, dyskinesia. GI disturbances. Cardiovascular disorders (tachycardia, palpitations, change in BP). Rash, pruritus, urticaria, fever, arthralgia, hair loss.
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, STRATTERA Lilly discontinuation, elderly. Epilepsy, not recommended. Contains Na+. Pregnancy, lactation; 2MO not recommended. Driving or using machines NA reuptake inhibitor. Atomoxetine (HCl) 10mg, (wait r 6 hours). 18mg, 25mg, 40mg, 60mg, 80mg. Opaque caps. White, gold/white, blue/white, blue and blue/gold, C Contra: Opoids, barbiturates. Avoid: Alcohol, benzodiazepines. Sedative hypnotics or brown/white resp. marked strength and Lilly followed by number. 7 day pack: 10mg and 25mg, other CNS depressants. GHB dehydrogenase stimulants or inhibititors (e.g. valproate, phenytoin A19.69; 28 day pack: 10mg, 18mg, 25mg, 40mg, or ethosuximide). TCAs. and 60mg, A77.68. S Attention-Deficit/Hyperactivity Disorder A Hypersensitivity, anorexia, sleep disorders, abnormal thinking, confusion, (ADHD) in children of 6 years and older and in adolescents as part of a comprehensive treatment depression, hallucination, agitation, dizziness, headache, sleep paralysis, somnolence, tremor, programme. amnesia, blurred vision, GI disorders, sweating, P Start of treatment not recommended. Q Under 6 years, not recommended. Up to rash, muscle cramps, enuresis nocturna, asthenia, fatigue, feeling drunk, increased BP. 70kg body weight: Initially, 0.5mg/kg as single daily dose in the morning. Maintenance, approx. 4.1 PAIN, PYREXIA 1.2mg/kg/day. Max. 1.8mg/kg/day. Over 70kg: Initial daily dose, 40mg. Maintenance, 80mg daily. ABSTRAL Fannin Max. 100mg daily. Maintain initial dose up to 7 days before upward dose titration. In some cases, 0 L O Opioid. Fentanyl (as citrate) 50mcg, 100mcg, consider treatment into adulthood. Some may 200mcg, 300mcg, 400mcg, 600mcg, 800mcg. White benefit from twice daily treatment in evenly divided doses. Stop abruptly in cases of significant sublingual tabs. Pentagon, round, oval, triangle, diamond, D and caps. shaped, resp. All strenghs: adverse effects; otherwise discontinue gradually. 10, A59.74; 30, A175.63. Treatment q 1 year; re-evaluation of therapy by S Breakthrough pain in patients using an ADHD specialist recommended. Hepatic opioid therapy for chronic cancer pain. insufficiency: v dose (if moderate); t dose (if P Initially, 100mcg; titrating upwards as severe). Patients with a known poor metaboliser genotype: Consider lower starting dose and slower necessary through the range of available dosage strengths (see SPC). Maintain established up titration of dose. appropriate dose with max. 4 doses/day. D Narrow angle glaucoma. Lactation, Q Under 18 years, not recommended. pregnancy (unless benefit outweighs risk). B Caution: Hypertension, tachycardia, CVD D Opioid-naive patients. Severe respiratory depression, severe obstructive lung conditions. or cerebrovascular disease, structural cardiac abnormalities, patients susceptible to hypotension, Lactation, pregnancy (unless clearly necessary). B Caution: COPD , myasthenia gravis, history of QT prolongation, history of seizure. susceptibility to intracranial effects of hyperkapnia Monitor BP and pulse, growth and development, (e.g. raised intracranial pressure, reduced cognition and sexual maturation (long-term consciousness, coma, brain tumours), head injury therapy). Allergic events. Jaundice (discontinue). (avoid), bradyarrhythmias, hypovolaemia, Monitor for suicide-related behaviour, hostility, hypotension, mouth wounds or mucositis. Kidney emotional lability, psychotic/manic symptoms. or liver dysfunction, elderly, cachectic/ debilitated C Contra: MAOIs (min. 2 weeks apart). patients; monitor for signs of fentanyl toxicity. Caution: High dose (nebulised or systemic) Driving/using machines. salbutamol (or other b2 agonists), QT prolonging C Caution: CYP3A4 inhibitors (see drugs, drugs causing electrolyte imbalance, CYP2D6 inhibitors, drugs lowering seizure Appendix I), other CNS depressants (eg. morphine threshold, pressor agents, drugs affecting NA. derivatives, general anaesthetics, skeletal muscle A Decreased appetite and weight, GI relaxants, sedative antidepressants, sedative H1 disorders, anorexia, influenza, early morning antihistamines, barbiturates, anxiolytics, hypnotics, awakening, irritability, mood swings, dizziness, antipsychotics, clonidine). Not recommended: somnolence, mydriasis, dyspepsia, nausea, skin Alcohol, MAOIs (within 14 days), partial opioid disorders, fatigue. Adults: GI disorders, insomnia. agonists/antagonists. A Dizziness, somnolence, headache, XYREM UCB fatigue. Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis, vision abnormal, 2MT
PAIN,
PYREXIA
4.1
respiratory depression, rhinitis, pharyngitis, GI disorders, Rash, pruritus, orthostatic hypotension, flushing, hot flush, asthenia, application site irritation, depression, anorexia, concentration impaired, euphoria.
ACTIQ
Cephalon
0LO Opioid agonist. Fentanyl 200mcg, 400mcg, 600mcg, 800mcg, 1200mcg, 1600mcg. Compressed lozenges with oromucosal applicator. 3 units, A27.51; 30 units, A275.15. S Management of breakthrough pain (BTP) in patients 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 oromuccosal admin. unit placed against the cheek and moved around the mouth for max. mucosal exposure. Initially 200mcg, titrated upwards through 200, 400, 600, 800, 1200, 1600mcg as necessary. Each unit should be consumed over 15 mins. and individually titrated to a ’successful’ dose. Monitor patients until a ’successful’ dose is reached. During treatment a second unit of the same strength may be consumed. Max. 2 units per episode and 4 units per day. See SPC. Q Under 18 years, not recommended. D MAOIs or within two weeks of use. Severe respiratory depression, severe obstructive lung conditions. Hypersensitivity. B Tolerance/dependence may develop. respiratory depression, COPD, head injury, increased intracranial pressure or impaired consciousness. Bradyarrhythmias, hepatic or renal impairment, hypovolaemia, hypotension. Oral hygiene recommended to avoid potential harm to teeth. Pregnancy, lactation. C CYP3A4 inhibitors such as macrolide antibiotics eg erythromycin, ketoconazole; certain protease inhibitors eg ritonavir; grapefruit juice, other CNS depressants incl. other opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines, alcohol. A Nausea, vomiting, constipation, dyspepsia, asthenia, headache, anxiety, confusion, dizziness, dry mouth, insomnia, somnolence, dyspnoea, pruritus, sweating, abnormal vision.
ACUPAN
Meda
2NO 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
Wyeth Healthcare
2K NSAID. Ibuprofen 200mg. Green translucent, oval soft gelatin cap. marked Advil one side in white
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
131
4.1 PAIN,
ANALGESIA
PYREXIA
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 hours. Q Under 12 years, not recommended. 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.
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 ANADIN Wyeth Healthcare enlargement. Severe hepatic impairment, moderate/severe renal impairment. Driving/ 2K Salicylate/xanthine. Aspirin 325mg, caffeine 15mg, operating machines. quinine sulphate 1mg. White film ctd tab. marked C MAOIs (contra). Caution: Alcohol, other CNS depressants, anticholinergics, TCAs, ANADIN. 12, A1.03; 24, A1.96. S Pain of headache, neuralgia, rheumatic sympathomimetics, bretylium bethanide, guanethidine, debrisoquine, methyldopa, a- and bpain, period pain, dental pain, toothache. adrenergic blockers, anticonvulsants, oral Common cold. contraceptives, metoclopramide, domperidone, P 2 three to four hourly as required. Max. cholestyramine, warfarin, other coumarins. 12 in 24 hours. A Drowsiness, dizziness, blurred vision, GI Q Under 16 years, not recommended. disturbances, dry mouth, nose and throat, urinary 2K ALSO ANADIN EXTRA Aspirin 300mg, paracetamol retention. 200mg, caffeine 45mg. White film ctd scored tab. BIODOL Niche with a break bar on one side and A and E 2MO embossed on reverse. 24, A2.74. S Headache, neuralgia, myalgia, Opiate analogue. Tramadol (HCl) 50mg. Olive and rheumatism, toothache, dysmenorrhoea, common yellow hard capsule containing a white powder. cold or flu. 100, A11.54. P 1-2 four hourly. Max. 6 in 24 hours. S Management (treatment and Q Under 16 years, not recommended. prevention) of severe pain. P Acute pain: 100mg initially, followed by 2K doses of 50-100mg every 4 hours. Chronic pain: ALSO ANADIN MAXIMUM STRENGTH Aspirin 500mg, caffeine 32mg. Yellow/green cap. marked 50mg initially; titrate according to severity. Max. 400mg per day. Anadin 500 both sides. 12, A1.35. S Headaches, neuralgia, rheumatic, period R As for adult dose. Q Under 12 years, not recommended. and dental pain, colds and flu. D Acute intoxication. P 1 three to four hourly; max. 8 in 24 B History of epilepsy, seizures. Head hours. injury, increased intracranial pressure, shock. Q Under 16 years, not recommended. Hepatic or renal insufficiency. Respiratory D Peptic ulceration, bleeding disorders. depression. Anaesthesia. Late pregnancy, lactation. C Alcohol, centrally acting drugs, MAOIs, B IBD, coagulation disorders, asthma. carbamazepine, lithium. SSRIs and TCAs (may Prolonged use. Elderly. Renal, cardiac or hepatic increase potential). impairment. C Warfarin, heparin. Caution: As with A Nausea, vomiting. Dry mouth, other NSAIDs. constipation (rare). Drowsiness, fatigue, dizziness, A Hypersensitivity reactions, asthma, renal headache. Rarely cardiovascular effects, rash, GI urate calculi formation, bleeding and tinnitus. GI irritation. Urinary retention. disorders or ulceration.
film-ctd tab. marked BRUFEN 600. 400mg-250, 600mg-100, A7.28.
A11.45;
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 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, ANADIN PARACETAMOL asthenia, pain, oedema, appl. site reaction. 2MO Wyeth Healthcare NSAID. Ibuprofen 800mg. White pillow-shaped, Ergha 2K film-ctd sust.-release tab. marked BRUFEN RETARD. BY-MADOL 2MO Analgesic. Paracetamol 500mg. White cap. shaped 56, A13.89. film-ctd scored tab. marked Anadin-P. 12, A1.24. S Mild to moderate pain. Dental and post Opiate analogue. Tramadol HCl 50mg. Yellow/ S Analgesic and antipyretic. green cap. marked TRA50. 100, A12.58. operative pain. Dysmenorrhoea. P 2 four hourly; max. 8 in twenty four P 2 as a single dose, preferably in the S Management of severe pain. hours. early evening, swallowed whole with plenty of P 50-100mg three or four times daily, Q Under 6 years, not recommended; 6-12 fluid. In severe or acute conditions, max. 3 daily in max. 400mg daily. years, 1 four hourly; max. 4 in twenty four hours. two divided doses. Q Under 12 years, not recommended; over B Renal and hepatic impairment. Q Under 12 years, not recommended. 12 years, as per adults.
BENYLIN DAY AND NIGHT
2MO
2MO
ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta ALSO BY-MADOL SR Tramadol HCI 100mg, 150mg, 200mg. Prolonged-release hard cap.
McNeil Healthcare sug-ctd tab. marked BRUFEN 400; magenta oval
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 100mg: Opaque yellow cap and natural transparent body; 150mg: Opaque yellow cap and body; 200mg: Opaque yellow cap and opaque white body. 100mg-60, A16.43; 150mg-60, A24.56; 200mg-60, A32.83. 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.
PAIN, 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.
PYREXIA
4.1
0LO
Opiate/anti-emetic Cyclimorph 10: Morphine tartrate 10mg, cyclizine tartrate 50mg. Cyclimorph 15: Morphine tartrate 15mg, cyclizine tartrate 50mg. Ampoules containing 1ml soln. for inj. 10mg-5, A6.71, 15mg-5, A6.96. S Moderate to severe pain where antiemesis is needed. CAPRIN Pinewood P 10-20 mg by SC, IM or IV inj.. Max. frequency: 4 hourly; not more than 3 doses/day. 2MO Salicylate. Aspirin 300mg. Pink ent-ctd tab. marked R Reduce dose. Q 1-5 years, 2.5-5 mg; 6-12 years, 5-10mg. CAPRIN. 100, A3.72. Both as max. single dose. Over 12 years, as for S Analgesic and antipyretic. adults. P 3 tabs (900mg) 3-4 times daily. D Respiratory depression, obstructed Q Not recommended. airways, excessive bronchial secretions. Attack of D Active peptic ulceration, coagulation bronchial asthma, HF secondary to chronic lung deficiency disorders, lactation. disease. Head injury or raised intra-cranial B Reye’s syndrome in children. Avoid: pressure. Moderate or severe renal impairment. Stroke patients, severe hepatic/renal impairment, Severe hepatic impairment. Ulcerative colitis. history of peptic ulceration or coagulation Biliary and renal tract spasm, patients immediately abnormalities, dehydration. Pregnancy (avoid at after operation of biliary tract. Acute alcohol term). Elderly. intoxication, MAOIs (wait 14 days after stopping). C Hypoglycaemic agents Pregnancy, lactation (insufficient data). (esp.sulphonylureas), uricosuric agents, B Hypothyroidism, adrenocortical methotrexate, antacids, antiepilectic agents insufficiency, hypopituitarism, myxoedema, (phenytoin & Na+ valproate), sulphonamides, prostatic hypertrophy, shock and diabetes mellitus, antihypertensives, iron salts and alkali. phaeochromocytoma, severe HF, glaucoma, A Allergic or asthmatic reactions. obstructive disease of GI tract. Elderly, debilitated Bronchospasm. patients. Driving or operating machine. Abrupt CATAFLAM Novartis withdrawal. C MAOIs. Phenothiazines, hypnotics, 2MO neuroleptics, alcohol, muscle relaxants (enhanced Phenylacetic acid. Diclofenac (K+) 25mg, 50mg. depressant effect). Anticholinergic drugs, Circular, biconvex, sugar ctd tabs. 25mg pale red; dexamphetamine, hydroxyzine, propranolol, 50mg reddish brown. 25mg-30, A1.90 ; 50mg-30, diuretics. A3.69. A Respiratory depression, raised intraS All grades of pain and inflammation cranial pressure, orthostatic hypotension, incl. acute musculo-skeletal disorders, painful CALPOL SUSPENSION drowsiness, confusion, dysphoria, restlessness, McNeil Healthcare conditions resulting from trauma, including low miosis, constipation, nausea, vomiting, skin back pain, fracture, sprains, strains, orthopaedic, reactions, biliary tract and renal spasm, vertigo, 2 dental and other minor surgery. Migraine, acute dry mouth, nose and throat, blurred vision, Analgesic. Paracetamol 120mg/5ml. Susp. 60ml, gout. Dysmenorrhoea. tachycardia, urinary retention, insomnia, auditory A2.17; 70ml, A2.40; 140ml, A4.29; Sachets: 12 x P 100-150mg in two or three divided and visual hallucinations, cholestatic jaundice. 5ml, A3.12. doses. Max. 150mg daily. S Pain (incl. teething pain), antipyretic. Q Under 14 years, not recommended; over CYMBALTA Lilly Q 6-12 years: 10-20 ml. 1-6 years: 5-10 ml. 14 years, 75-100mg in two or three divided doses. 2NO 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. 5HT/NA reuptake inhibitor. Duloxetine (HCl) 30mg, 60mg. Opaque caps. White body marked 30mg months: 2.5 ml for post-vaccination fever at 2 B Renal, cardiac or hepatic impairment. with blue cap marked 9543; green body marked months, followed if necessary by same dose 4 to 6 Elderly. Pregnancy, lactation. 60mg with blue cap marked 9542 resp. 30mg-28, hours later; other, consult doctor. C Lithium, digoxin, anticoagulants, A 20.50; 60mg-28, A 34.15. 2 antidiabetic agents, cyclosporin, methotrexate, S Diabetic peripheral neuropathic pain. quinolone antimicrobials, other NSAIDs, ALSO CALPOL SUGAR-FREE Paracetamol 120mg/ P Recommended dose, 60mg once daily. 5ml. 60ml, A2.17; 140ml, A4.29; Sachets: 12 x 5ml, corticosteroids, diuretics. Max. 120mg daily given in evenly divided doses. A Epigastric pain, nausea, headache, A3.12. Evaluate response after 2 months; reassess at least Q 1-6 years: 5-10 ml. 3 months-1 year: 2.5- dizziness, rash, elevation of liver enzymes. every 3 months. Discontinue gradually over 1-2 5 ml. Both, repeat every 4 hours, if necessary; max. weeks. CODANT Antigen 4 doses per 24 hours. Under 3 months: 2.5 ml for Q Under 18 years, not recommended. 2NO post-vaccination fever at 2 months, followed if D Liver disease resulting in hepatic necessary by same dose 4 to 6 hours later; other, Opiate. Codeine phos. 30mg. White tab. 100, impairment, severe renal impairment (ccQ30ml/ A9.73. consult doctor. min), uncontrolled hypertension. Pregnancy (unless 2 S Mild to moderate pain. essential), lactation. P 1 four hourly as required. ALSO CALPOL SIX PLUS Paracetamol 250mg/5ml. B History of mania, bipolar disorder, Q Not recommended. Susp. 70ml, A3.10; Sugar-free, 70ml, A3.10. seizures, increased IOP or risk of acute narrowD Intestinal obstruction, Respiratory P 10-20ml every four hours. Max. 80ml angle glaucoma. Hypertensive crisis reported. depression. per day. Hypertension, cardiac disease; monitor BP at least B UC. Pregnancy. Codine may cause Q Under 6 years, not recommended. 6-12 1st month. Elderly. Suicidal thoughts; monitor constipation. Tolerance/dependence may occur years, 5-10ml every four hours; max. 4 doses per carefully. May occur: Liver injury, incl. severe with repeated use. day. elevations of liver enzymes, hepatitis and jaundice. C Alcohol and other CNS depressants. 2 Akathisia may develop. Driving/using machines. A Dizziness, sedation, constipation, ALSO CALPOL FASTMELTS Paracetamol 250mg. Contains sucrose. nausea, pruritus. Orodispersible tabs. 12, A2.04; 24, A3.30. C Non-selective, irreversible MAOIs and P As for children over 12 years. potent CYP1A2 inhibitors, eg. fluvoxamine, CYCLIMORPH Amdipharm ciprofloxacin, or enoxacine (all contraindicated), Q Over 12 years: 2-4; 6-12 years: 1-2. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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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, musculoskeletal pain, muscle tightness, muscle spasm, decreased appetite, flushing, fatigue, abdominal pain, erectile dysfunction, insomnia, agitation, decreased libido, anxiety, abnormal orgasm, abnormal dreams.
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. DF 118 Galen P 1 dissolved in water every 3-4 hours., 2LO max. 8 in twenty-four hours. Opiate. Dihydrocodeine tartrate 30mg. White tab. Q Under 16 years, not recommended. A A marked with tab. name. 100, 4.53; 500, 20.77. D See SPC. S Moderate to severe pain. DOZOL Ricesteele P 1 four to six hourly after meals. Q Not recommended. 2K D Respiratory depression, obstructive Analgesic/antihistamine. Paracetamol 120mg, airways disease. diphenhydramine (HCl) 12.5mg per 5ml. Clear B Chronic hepatic disease. Renal amber oral soln with caramel odour. 30ml, A1.42; insufficiency. Allergy, hypothyroidism. Pregnancy. 100ml, A2.98. Elderly. S Teething pains, irritability associated C Alcohol, CNS depressants, MAOIs. with injections or feverishness, aches or pains, A Constipation, nausea, headache, vertigo. colds and flu, associated sleeplessness. See SPC. Q Under 2 years, contraindicated; 2-6 years, 5-10ml (1-2 teaspoonsful) three or four DIFENE Astellas times daily; over 6 years, 10-20ml three times 2NO daily. D Epilepsy, fructose intolerance. Phenylacetic acid. Diclofenac Na+ 25mg/ml. 3ml B Driving/using machines (may cause amp. 10 x 3ml, A5.60. drowsiness). Pregnancy (no data). S Acute back pain, post-operative pain, C Contra: Cough and cold medicines, renal colic. paracetamol containing products. Caution: P 75mg IM once or twice daily by deep Alcohol, sedatives. intragluteal inj. for max. 2 days. Post- operative A Rare but hypersensitivity incl. rash may pain: Admin. 75mg IV diluted in 300ml normal occur. saline and inf. over min. 30 mins; a second dose can be given 8 hrs later; max. 2 inf. in 24 hrs. DUROGESIC DTRANS Janssen-Cilag Continue if necessary with tabs. or suppos. Q Not applicable. 0LO D History of GI bleeding or perforation, Opiate. Fentanyl 12, 25, 50, 75, 100mcg/hr. related to previous NSAID therapy. Active, or Transdermal matrix patches. 12mcg-5,A24.68; history of, recurrent peptic ulcer/haemorrhage. 25mcg-5; A35.70; 50mcg-5, A66.68; 75mcg-5, Aspirin/anti-inflammatory induced allergy. Severe A92.96; 100mcg-5, A114.57. HF. In ulcerative or acute inflammatory conditions S Chronic intractable pain in patients of the anus, rectum (proctitis) and sigmoid colon. requiring opioid analgesia. B Use lowest effective dose. Elderly. P New opioid patients: Initially one History of GI disease/toxicity. Risk of GI bleeding, 25mcg/hr patch. May subsequently be titrated up ulceration or perforation. Risk of hypersensitivity or down, in increments of 12 or 25mcg/hr reactions. May mask infection. Serious skin depending on response. Opioid tolerant patients: reactions have been reported rarely. Renal, cardiac Apply strength of patch according to previous or hepatic impairment. Bleeding abnormalities. analgesics; see SPC. Apply patch to non-hairy area Long-term use. May impair female fertility; not of chest or upper arm. Analgesic effect should not recommended in women attempting to conceive. be evaluated until patch worn for 24 hrs. Remove Pregnancy, lactation. and replace with new patch every 72 hrs using C Lithium, digoxin, anticoagulants, antidifferent site. Consider other analgesics if dose platelets, SSRIs, cyclosporin, methotrexate, exceeds 300mcg/hr. quinolones, other NSAIDs and steroids, Q Under 2 years, not recommended. corticosteroid, diuretics, cardiac glycosides, antiOpioid-tolerant paediatric patients ages 2-16 years: hypertensives, aminoglycosides, probenecid. Dose based upon daily oral morphine dose,12mcg/ A GI disorders, headache, dizziness, h patch if morphine 30-44mg/day; 25mcg/h patch vertigo, rashes or skin eruptions, raised ALT, AST. if morphine 45-134mg/day. Apply to upper back. D Acute pain. Pregnancy, lactation. DISPRIN Reckitt Benckiser B Respiratory depression, chronic 2K pulmonary disease, increased intracranial pressure, Salicylate. Aspirin 300mg. White soluble tab. brain tumour, bradyarrhythmias, renal or hepatic marked with logo and DISPRIN one side. 12, impairment, fever or direct heat. Use in patients A1.54; 24, A2.37. who showed opioid tolerance. Tolerance and S Mild to moderate pain, pyrexia, dependence may develop rarely. Elderly or headache, toothace, neuralgia, lumbago. debilitated patients. Different brands of fentanyl P 1-2 in water four hourly. Max. 12 in patches are not interchangeable. Dispose of twenty-four hours. patches with care. Do not admin. in opioid-naive
134
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.
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.
EFFENTORA
Cephalon
0LO 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
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,
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). B Keep out of reach of children. Closely monitor during titration. The long acting opioid treatment should be stabilised before beginning therapy. Caution: Non-severe COPD or other conditions predisposing to respiratory depression, evidence of increased intracranial pressure or impaired consciousness, pre-existing bradyarrhythmias, hepatic or renal impairment. Hypovolaemia and hypotension. Tolerance and physical and/or psychological dependence may develop. Use in head injury patients only if clinically warranted. Lactation (if benefits outweigh risks). C CYP3A4 inducers and inhibitors, CNS depressants. Not recommended: Within 14 days of MAOIs, partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine). A Dizziness, dysgeusia, somnolence, lethargy, headache, tremor, sedation, nausea, vomiting, constipation, stomatitis, dry mouth, diarrhoea, pruritis, hyperhydrosis, application site reactions (incl. pain, ulcer, irritation, paraesthesia, anaesthesia, erythema, oedema, swelling and vesicles), fatigue, disorientation, euphoric mood.
FEMINAX
Bayer HealthCare
2 Compound analgesic/anticholinergic. Paracetamol 500mg, codeine phos. 8mg, caffeine 50mg, hyoscine hydrobrom. 0.1mg. White cap.-shaped scored tab. marked FEMINAX. 20, A3.63. S Menstrual cramps. P Over 12 years, 1-2 four hourly; max. 6 in 24 hrs. Q Not applicable. D Glaucoma. Pregnancy. B Renal or hepatic impairment. 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
PYREXIA
4.1
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.
Antiepileptic. Gabapentin 100mg, 300mg, 400mg. Hard gelatine caps. with white (100mg), yellow (300mg) or orange (400mg) opaque body. 100mg100, A16.92; 300mg-100, A39.20; 400mg-100, A45.36. S Peripheral neuropathic pain such as painful diabetic neuropathy and post-herpetic neuralgia. P Titrate 300mg once daily (Day 1), twice daily (Day 2) and three times daily (Day 3); alternatively 300mg three times daily on Day 1 swallowed whole with water. Can then be increased in 300mg/day increments every 2-3 days up to max. 3600mg/day. Renal impairment: See SPC. D Pregnancy, lactation (unless benefit outweighs risk). B Acute pancreatitis (discontinue). Mixed seizures including absences (caution). Long-term therapy (q 36 weeks) in children and adolescents (no data). False positive in dipstick tests (total urine protein). Driving/operating machines. Contains lactose. C Morphine (caution). Take min. 2 hrs after antacid. A CNS effects eg. somnolence, dizziness, ataxia. Infections eg. viral, RTI, UTI. Psychiatric disorders eg. hostility, confusion, emotional lability. Fatigue, fever, oedema, abnormal gait, pain, flu syndrome, arthralgia, myalgia, purpura, GABAPENTIN TEVA Teva rash, vertigo. Hypertension, vasodilatation, visual disturbances. Respiratory/GI disorders. 2MO Incontinence, impotence. WBC decreased, GABA analogue. Gabapentin 600mg, 800mg. leucopenia, weight gain, appetite change. White to off-white, oval shaped, bevelled edged, Accidental injury. Aggressive behaviour and film-ctd tab. engraved 7173 (600mg) or 7174 hyperkinesias in children. (800mg) on 1 side and 93 the other. 600mg-100, A83.64; 800mg-100, A101.66. GERICARB SR Gerard S Treatment of peripheral neuropathic pain (e.g. painful diabetic neuropathy, post2MO herpetic neuralgia) in adults. Dibenzazepine. Carbamazepine 200mg, 400mg. P Initiate by dose titration: 300mg once White to yellowish, round, flat, cloverleaf shaped daily on day 1, increasing to 300mg twice daily on prolonged release tabs with bevelled edge, day 2, then 300mg 3 times daily on day 3. double-sided cross break-mark, 4 notches on band. Alternatively initiate with 900mg/day given as 3 Can be divided into equal halves. 200mg-56 equally divided doses. Thereafter, can be increased A4.48; 400mg-56, A8.85. in 300mg/day increments every 2-3 days up to S Paroxysmal pain of trigeminal neuralgia. 3600mg/day maximum. Renal impairment, P Initially 100-400mg in divided doses haemodialysis: See SPC. increasing gradually to control, usually 600-800mg R Adjust according to renal function. daily taken in 1-2 doses. Max. 1600mg daily. May D Pregnancy, lactation (unless benefit be gradually reduced if patient is pain-free. outweighs risk). Q Not applicable. B Consider discontinuation if acute D Bone marrow depression, AV pancreatitis develops. Caution in patients with conduction abnormalities, acute intermittent mixed seizures incl. absences. Assess risks/benefits porphyria. of prolonged therapy in children and adolescents. B Evaluate benefit/risk: Haematological Monitor for signs of suicidal ideation and disturbances, disturbed Na+ metabolism, severe behaviours. False positive in dipstick tests (total cardiac, liver and kidney dysfunction, myotonic urine protein). Withdraw gradually. Pregnancy, dystrophia, pregnancy, lactation. Patients should lactation. Driving/operating machinery. consult immediately if fever, sore throat, rash, C Morphine, antacids. ulcers in the mouth, easy bruising, petechial or A IInfections (e.g. viral, UTI, RTI, otitis purpuric haemorrhage, nausea, skin yellowing and media, pneumonia), leucopenia, anorexia, liver enlargement occurs. Caution: Severe cardioincreased appetite, psychiatric and nervous system vascular disease, liver disease or renal damage, disorders, visual disturbances, vertigo, elderly, glaucoma (regulary check IOP), high doses. hypertension, vasodilatation, dyspnoea, bronchitis, May trigger or exacerbate absences. Increase in pharyngitis, cough, rhinitis, GI disorders, facial seizure frequency or the onset of new types of oedema, purpura, rash, pruritus, acne, arthralgia, seizures may occur. Test blood regularly; myalgia, back pain, twitching, incontinence, discontinue if severe leucopenia or impotence, fatigue, fever, peripheral or thrombocytopenia appear. Perform liver function generalized oedema, abnormal gait, asthenia, tests periodically. Discontinue if severe pain, malaise, flu syndrome, decreased WBC, dermatological reactions, severe hypersensitivity weight gain. occur. Avoid sunlight exposure. Driving/operating machines. GABIN Rowex C Not recommended: MAOIs. Caution: Anticonvulsants, CYP450 inducers/inhibitors, 2MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
135
4.1 PAIN,
ANALGESIA
PYREXIA
digoxin, theophylline, cisplatin, doxorubicin, clonazepam, St. Johnâ&#x20AC;&#x2122;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.
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, INSTANYL Nycomed altered state of consciousness, problems affecting 0L respiratory centre or respiratory function, Opioid. Fentanyl (as citrate) 50mcg, 100mcg, increased intracranial pressure. Withdrawal 200mcg/dose nasal spray. Sln. For all strengths: 10, symptoms may occur. Avoid use during light A91.70; 20, A183.40. planes of anaesthesia. S Breakthrough pain in patients using C Contra: MAO inhibitors up to 2 weeks opioid therapy for chronic cancer pain. after withdrawal, acute intoxication with alcohol, P Initially, 50mcg in one nostril, titrating hypnotic drugs, centrally-acting analgesics, opioids upwards as necessary. Max. daily dose: Treatment or psychotropic drugs. Not recommended: of up to 4 breakthrough pain episodes, each with Carbamazepine and other enzyme inducers, opioid no more than 2 doses separated by at least 10 agonists-antagonists (buprenorphine, nalbuphine, mins. Maintain with established adequate dose. pentazocine). Caution: SSRIs, triptans, other opioid Wait at least 4 hours before treating new episode. derivatives, benzodiazepines, barbiturates, Q Under 18 years, not recommended. anxiolytics, hypnotics, sedative antidepressants, D Use in opioid-naive patients. Severe sedative antihistamines, neuroleptics, centrallyrespiratory depression or severe obstructive lung acting antihypertensive drugs, thalidomide, conditions. Previous facial radiotherapy. Recurrent baclofen, warfarin-like compounds, CYP3A4 episodes of epistaxis. Lactation, pregnancy (unless inhibitors, seizure threshold reducing products clearly necessary). (e.g. bupropion, TCAs, neuroleptics), B Respiratory/circulatory depression, metoclopramide, domperidone, cholestyramine, hypotension and shock may occur (monitor ondansetron. closely). Caution: Elderly, cachectic, or debilitated A Dizziness, somnolence, headache, patients, moderate to severe renal/hepatic trembling, confusion, mood changes, sleep impairment, COPD, increased intracranial pressure, disorders, GI disorders, sweating, pruritus. impaired consciousness or coma, cerebral tumour, head injury, bradyarrhythmias, hypotonia, KAPAKE Galen hypovolaemia. Driving/using machines. 2NO C Avoid: MAOIs (within 14 days), nasal decongestants, partial opioid agonists/ antagonists Compound analgesic. Paracetamol 500mg, codeine phosphate 30mg. White oval scored tab. marked (e.g. buprenorphine, nalbuphine, pentazocine). KAPAKE. 100, A8.11. Caution: Moderate / strong CYP3A4 inhibitors, S Treatment of severe pain. CYP3A4 inducers (see Appendix I), other CNS P 1-2 four hourly as required; max. 8 in depressants, eg. other opioids, sedatives or twenty-four hours. hypnotics, general anaesthetics, phenothiazines, Q Under 12 years, not recommended. tranquillisers, skeletal muscle relaxants, sedating D Respiratory depression, obstructed antihistamines, alcohol. airways, raised intracranial pressure. Acute A Dizziness, somnolence, headache, alcoholism. vertigo, flushing, hot flush, throat irritation, B Renal or hepatic impairment, nausea, vomiting, hyperhidrosis. hypothyroidism, BPH, inflammatory or obstructive bowel disease. Elderly. Labour. Pregnancy, lactation. C Alcohol or CNS depressants may increase any sedative effect. A Tolerance, dependence, constipation, dizziness, sedation, nausea, dry mouth, blurred IXPRIM Grunenthal Pharma vision.
136
KERAL
A. Menarini
2MO NSAID. Dexketoprofen (as trometamol) 25mg. White scored film-ctd tab. 50, A12.62. S Musculoskeletal pain, dysmenorrhoea, dental pain. (topical gel see Fastum). P 12.5mg every 4-6 hours or 25mg eight hourly given 30 mins. before food. Max. 75mg daily. R Initially 50mg daily. Q Not recommended. D Severe renal or hepatic dysfunction. Active peptic ulcer or history of recurrent GI ulcer. Crohnâ&#x20AC;&#x2122;s disease or ulcerative colitis. Asthma. Severe HF. Aspirin/anti-inflammatory induced allergy. Pregnancy, lactation. B History of allergic conditions, haematopoietic disorders. Impaired hepatic, renal or cardiac function. Elderly. C Anticoagulants, lithium, methotrexate, hydantoin, sulphonylureas, b-blockers, cyclosporin, probenecid. A Dyspepsia, heartburn, abdominal pain, headache, dizziness.
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 ulceration or bleeding). History of GI bleeding or perforation, related to previous NSAID therapy. Severe heart failure, hepatic failure and renal failure. Pregnancy. Contains soya. B Caution: Elderly, bronchial asthma, asthma, seasonal allergic rhinitis, swelling of nasal mucosa, COPD, chronic RTIs, long-term treatment, hepatic porphyria, severe hepatic impairment, defects of haemostasis, bleeding diathesis, haematological abnormalities, history of GI toxicity. Discontinue if liver function worsens. Monitor renal function: Impaired renal/ liver function, cardiac impairment, elderly, patients recovering from major surgery. Use after careful consideration: Uncontrolled hypertension, CHF, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease, hyperlipidaemia, diabetes mellitus, smoking. Increased risk of aseptic meningitis with systemic lupus erythematosus (SLE) and mixed connective tissue disorders. May occur: Allergic reactions; GI bleeding, ulceration or perforation (withdraw);
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 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, LEMSIP Reckitt Benckiser antidiabetics (adjust dose). A Dizziness, tiredness. Increased appetite, 2 Analgesic and antipyretic. Paracetamol 500mg per weight gain, euphoric mood, confusion, change in libido, irritability, attention disturbances, sachet. Powder for oral soln. with lemon taste. 5, clumsiness, memory impairment, tremor, speech A2.56; 10, A3.81. difficulty, paraesthesia, visual disturbances, S Common cold and flu. vertigo, dry mouth, GI disorders, erectile 2 dysfunction, peripheral oedema, drunken feeling, ALSO LEMSIP COLD & FLU HEADCOLD abnormal gait. Paracetamol 500mg per sachet. Powder for oral soln. 5, A2.77; 10, A3.98. MATRIFEN Nycomed P 1 sachet every 4 hours, if necessary, up 0LO to max. of 6 sachets in 24 hrs. Opiate. Fentanyl 12, 25, 50, 75, 100mcg/hr. Q Under 12 years, not recommended. Transdermal patches. 12mcg/hr-5, A20.39; 25mcg/ 2 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 Paracetamol 1000mg, pseudoephedrine HCI 60mg Chronic pulmonary disease, increased intracranial pressure, coma, brain tumour, bradyarrhythmias, per sachet. Powder for oral soln. 6, A5.31. hypovolemia, hypotonia, renal or hepatic S Sinusitis, common cold and flu. P 1 sachet up to three times daily. Max. of impairment, fever or direct heat. Tolerance and dependence. Elderly or debilitated patients. 3 sachets in 24 hrs. Driving/using machines. Q Not recommended. C Contra: MAOIs (within 14 days). Avoid D Hepatic or renal impairment. barbituric acid derivatives, potent CYP3A7 B Impaired kidney and liver function, inhibitors (e.g. ritonavir, ketoconazol, itraconazol, diabetics, prolonged use. Pregnancy, lactation. macrolide antibiotics). Caution: Other CNS Capsules: Caution, history of peptic ulcer. Lemsip Max: Caution, thyrotoxicosis, glaucoma or urinary depressants, pentazocine, buprenorphine. A GI disorders, somnolence, headache, retention. sedation, depression, anxiety, confusion, C Chloramphenicol, coumarin anticoagulants, other drugs affecting liver. Lemsip hallucinations, lowered appetite, xerostomia, dyspepsia, pruritus, sweating, skin reaction. Max: MAOIs, sympathomimetics. serious skin reactions (rarely), fluid retention, oedema (caution with hypertension and CHF). May impair female fertility. Lactation (avoid). C Avoid other NSAIDs. Caution: Diuretics, antihypertensive agents, cardiac glycosides, lithium, digoxin, methotrexate, ciclosporin, mifepristone, corticosteroids, anti-coagulants, quinolones, anti-platelet agents, antidiabetics, tacrolimus, zidovudine, SSRIs. A Headache, dizziness, vertigo, GI disorders, increased transaminases, rash.
PAIN,
PYREXIA
4.1
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.
MEFAC
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.
MEPTID
Shire
2NO
Opiate partial agonist. Meptazinol (HCl) 200mg. Orange film-ctd oval tab. marked MPL023. 100, A24.16; 112, A27.06. S Short term treatment of moderate pain. MAXILIEF Clonmel P 1 three to six hourly as required. 2KO Q Not recommended. Compound analgesic. Paracetamol 500mg, codeine 2 N O phos. 8mg, caffeine 30mg. White effervesc. scored ALSO MEPTID INJECTION Meptazinol (HCl) 100mg/ tab. 12, A2.15; 24, A2.91. ml. Amp. 10 x 1ml, A21.14. LYRICA Pfizer S Moderate to severe pain, incl. postS Headache, musculoskeletal pain, 2MO operative pain, obstetric pain and pain of renal toothache, backache, common cold, influenza, GABA analogue. Pregabalin 25mg, 50mg, 75mg, colic. menstrual pain. 100mg, 150mg, 200mg, 300mg. Hard gelatine cap., P 2 dissolved in water three or four times P 75-100mg IM or 50-100mg IV Repeat marked Pfizer on cap., and PGN and strength on every two to four hours as required. Obstetric daily. body. 25mg-56, A81.70; 84, A122.55; 50mg-84, pain, 2mg/kg body weight IM Q Under 7 years, not recommended; 7-12 A122.55; 75mg-56, A81.70; 100mg-84, A122.55; Q Not recommended. years, v-1 in water three or four times daily. 150mg-56, A81.70; 200mg-84, A122.55; 300mg-56, B Renal or hepatic impairment. Elderly, B Hepatic or renal insufficiency. Severe A81.70. prostate hypertrophy, inflammatory or obstructive respiratory depression. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
137
4.1 PAIN,
ANALGESIA
PYREXIA 100, A53.37. S Neuropathic pain.
A Dizziness, nausea.
MST CONTINUS
2K
Mundipharma P Initially 900mg/day in 3 divided doses,
0LO Opiate. Morphine sulph. 5mg white tab.; 10mg brown tab.; 15mg light green tab.: 30mg purple tab.; 60mg orange tab.; 100mg grey tab. All filmctd sust.-release tabs. marked with strength and NAPP. 5mg-60, A4.75; 10mg-60, A8.94; 15mg-60, A13.88; 30mg-60, A21.46; 60mg-60, A41.83; 100mg-60, A66.24.
0LO ALSO MST CONTINUS SUSP Morphine (equiv. to morphine sulph. 20mg, 30mg, 60mg, 100mg, 200mg). Grans. in sachet for raspberry flavoured cont.-release susp. 20mg-30, A30.17; 30mg-30, A31.89; 60mg-30, A65.92; 100mg-30, A109.87; 200mg-30, A219.74. S Prolonged relief of severe pain. P Initially 10-20mg twelve hourly. Severe pain, 30mg twelve hourly increasing to 60mg twelve hourly when required. If higher doses are necessary they should be made in 25%-50% increments. Mix contents of sachet with min. 10ml water. Q A starting dose in the range of 0.20.8mg/kg twelve hourly. Doses should be titrated as for adults. D Pregnancy, lactation. Respiratory depression, obstructive airways disease. Acute hepatic disease. Acute alcoholism, head injury, coma, convulsive disorders, raised intracranial pressure. Paralytic ileus. B Hypothyroidism, renal and chronic hepatic disease. Elderly. Shock, adrenocortical insufficiency. C MAOIs, CNS depressants. Phenothiazines, anaesthetics, hypnotics, alcohol. A Tolerance, dependence. Constipation, nausea, vomiting.
titrated by 300mg once daily on day 1, 300mg twice daily on day 2, 300mg three times daily on day 3. May be titrated up to max. 3600mg per day. Renal impairement, haemodialysis: See SPC. R Adjust according to renal function. Q Under 18 years, not recommended. B Mood and behavioural disturbances may occur. Monitor for suicidal ideation. Withdraw gradually over at least 1 week. Pregnancy (only use if clearly needed), lactation. Driving/using machines. C Caution: Morphine, antacids. False positive readings reported with Ames N-Multistix SG dipstick test. A Dizziness, somnolence. See SPC.
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. NU-SEALS 300 Alliance Q Over 6 years only. 20-30mg/kg body 2MO weight in divided doses, as follows; 6-9 years: Initially 2 tab., then if necessary 2 tab. every 4-6 Salicylate. Aspirin 300mg. White ent-ctd tab. hours. Max. 6 tab. in 24 hours. 10-12 years: marked 300 in red. 100, A4.76. Initially 3 tab., then if necessary 3 tab. every 4-6 S Prolonged pain. hours. Max. 9 tab. in 24 hours. P 300-900mg 3 or 4 times daily. Max. 8g 2K daily. Q Under 16 years, not recommended. ALSO NUROFEN FOR CHILDREN SUPPOSITORIES D Hypoprothrombinaemia, haemophilia, AGE 3 MONTHS-2 YEARS Ibuprofen 60mg. White cerebral haemorrhage, active peptic ulceration, or yellowy-white cylindrical suppositories. 10, A4.66. lactation. B Not for short-term pain relief. Renal, S Reduction of fever and relief of mild to cardiac or hepatic impairment. May induce GI moderate pain, such as teething pain, toothache, haemorrhage. Long-term use, elderly; review headache, sprains and strains and to ease the pain regularly. Caution: History of IBD, coagulation of sore throats and earache. Relief of pain and abnormalities. Hypertension, monitor. Pregnancy fever associated with colds and influenza. (avoid at term). Q For rectal use only. 3 - 9 months (6 C AAvoid: Warfarin, heparin, other 8kg), 1 suppositary 3 times daily at 6 - 8 hours NSAIDs, antacids (simultaneous use). Caution: Anti- interval. 9 months - 2 years (8 - 12kg), 1 hypertensives, diuretics, cardiac glycosides, lithium, suppositary 4 times daily at 6 hours interval. methotrexate, ciclosporine, tacrolimus, D History of/or existing stomach ulcer, corticosteroids, aminoglycosides, probenecid, oral other GI disorders. History of asthma, rhinitis, NEURONTIN Pfizer hypoglycemics, anticoagulants, antiplatelets, urticaria associated with aspirin or other NSAIDs. fibrinolytics, carbonic anhydrase inhibitors, In case of Nurofen Plus only, chronic constipation, 2MO ibuprofen. breathing difficulties. GABA analogue. Gabapentin 100mg white cap.; A Asthma, urate kidney stones, chronic GI B Asthma, renal, cardiac or hepatic 300mg yellow cap.; 400mg orange cap.; 600mg blood loss, tinnitus, nausea, vomiting. impairment, intracranial haemorrhage and white tab.; 800mg white tab. All marked with bleeding diathesis, history of GI disease (ulcerative name and strength. 100mg-100, A24.86; 300mgNUROFEN Reckitt Benckiser colitis, Crohnâ&#x20AC;&#x2122;s disease), elderly. Pregnancy, 100, A57.65; 400mg-100, A66.71; 600mg-100, lactation. (In addition for Plus only, low BP, head 2K A104.55; 800mg-100, A127.08. injury, thyroid disease). May occur: GI bleeding, NSAID. Ibuprofen 200mg. White sug-ctd tab. 12, S Treatment of neuropathic pain. ulceration or perforation, arterial thrombotic A2.12; 24, A3.53; 48, A5.86. P Initially 300mg once daily on day 1, events, serious skin reactions (discontinue). 2K increasing to 300mg twice daily on day 2, then Meltlets contain aspartame. 300mg three times daily on day 3. Thereafter dose ALSO NUROFEN LIQUID CAPSULES Ibuprofen C Warfarin, heparin, anti-hypertensives, can be increased using increments of 300mg per 200mg. Liquid in red cap. marked NUROFEN. 16, diuretics, cardiac glycosides, lithium, methotrexate, day given in three equally divided doses to a max. A3.24. cyclosporin, NSAIDs, corticosteroids, of 3600mg per day. Effective dose range is 900S Mild to moderate pain such as aminoglycosides, probenecid, oral hypoglycaemics, 3600mg daily. headache, dental pain, backache, feverishness, anti platelet agents, SSRIs. (In addition for Plus Q Under 18 years, not recommended. period pain, muscle strain, neuralgia, rheumatic B Elderly, haemodialysis, renal impairment pain, migraine, management of symptoms of head only, MAOIs). A GI disturbance/bleeding, peptic ulcer, (see SPC), mood and behavioural disturbances. cold and influenza. allergic reactions, thrombocytopaenia. In addition Ability to drive or operate machinery may be P Initially 2 followed by 1-2 four hourly. for Plus, constipation, breathing difficulties). affected. Pregnancy, lactation. Max. 6 in 24 hours. C Caution: Morphine, antacids. Q Under 12 years, see Nurofen for ORAMORPH ORAL SOLUTION A CNS effect (somnolence, dizziness, dry children. Over 12 years, same as adults. Boehringer Ing. mouth), GI disturbances (diarrhoea, nausea), 2K headache, asthenia, infection, accidental injury, 0LO ALSO NUROFEN PLUS Ibuprofen 200mg, codeine abdominal pain. Opiate. Morphine sulph. 10mg/5ml. Sugar-based phosphate 12.8mg. White cap.-shaped tab. 12, oral soln. 100ml, A2.85; 300ml, A7.56; 500ml, A3.09; 24, A5.26. NEUROSTIL Teva S Migraine, cramping period pain, dental A11.40. 0 LO 2MO pain, sciatica, lumbago, rheumatic pain. ALSO ORAMORPH CONC. ORAL SOLUTION GABA analogue. Gabapentin 100mg, 300mg, P Initially 2 followed by 1-2 four hourly. Morphine sulph. 20mg/ml. Sugar-free oral soln. 400mg. Resp. grey, orange or brown hard cap. Max. 6 in 24 hours. marked resp. 93 and 38, 93 and 39 or 93 and 40. Q Under 12 years, not recommended.Over 30ml, A7.60; 120ml, A28.40. 100mg-100, A19.89; 300mg-100, A46.12; 400mgS Relief of severe and intractable pain 12 years, same as adults.
138
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c
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA
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.
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, tolerated for a full 12 hours. In debilitated elderly prostatic hypertrophy, adrenocortical insufficiency, patients or opioid naive patients the usual starting acute alcoholism, chronic renal and hepatic dose is 10mg twelve hourly. The dose should be disease, debilitated patients. Abdominal surgery, titrated in 25-50% increments. possibility of paralytic ileus occurring. Q Under 20 years, not recommended. C Contra: MAOIs or within 2 weeks of use. D Respiratory depression, head injury, Caution: CNS depressants, phenothiazine, TCADs, paralytic ileus, acute abdomen, delayed gastric anaesthetics, hynotics, sedatives, alcohol, emptying, severe obstructive airways disease, musclerelaxants, antihypertensives, quinidine, severe bronchial asthma, hypercarbia. Concurrent cimetidine, CYP3A4 substrates/inhibitors. admin. of MAOIs or within 2 weeks of A GI disorders, dry mouth, dizziness, discontinuation of use. Pre-operatively and for 24 headache, somnolence, anxiety, confusion, hours post-operatively. Sensitivity to morphine or insomnia, asthenia, dyspnoea, bronchospasm, other opioids. Acute hepatic disease. Pregnancy, orthostatic hypotension, pruritus, urinary lactation. disorders, fever, chills. Tolerance, withdrawal B Hypothyroidism, opioid dependent syndrome. patients, raised intracranial pressure, hypotension, PALLADONE SR Mundipharma hypovolaemia, diseases of the biliary tract, pancreatitis inflammatory bowel disorders, 0LO prostatic hypertrophy, adrenocortical insufficiency, Opiate. Hydromorphone (HCl) 2mg yellow/clear acute alcoholism, chronic renal and hepatic cap.; 4mg pale blue/clear cap. marked HCR4; 8mg disease, debilitated patients. Abdominal surgery, pink/clear cap. marked HCR8; 16mg brown/clear possibility of paralytic ileus occurring. cap. marked HCR16; 24mg dark blue/clear cap. C MAOIs, CNS depressants, phenothiazine, marked HCR24. 2mg-56, A24.75; 4mg-56, A26.03; TCADs, anaesthetics, hynotics, sedatives, alcohol, 8mg-56, A50.76; 16mg-56, A95.43; 24mg-56, musclerelaxants, antihypertensives, cimetidine. A137.43. A Respiratory depression, tolerance, S Relief of severe pain. constipation, nausea, dizziness, vomiting, P Caps. may be swallowed whole or headache, dry mouth, sweating, drowsiness, contents sprinkled onto soft food, taken at 12 asthenia. Abrupt withdrawal may result in a hourly intervals. Dosage depends on severity of withdrawal syndrome. pain. See SPC. Q Under 12 years, not recommended.
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.
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.
PYREXIA
4.1
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.
PANADEINE
GSK
2 Compound analgesic. Paracetamol 500mg, codeine phos. 8mg. White scored tab. marked PANADEINE. 24, A3.20; 48, A4.69. S Painful and febrile conditions. P 1-2 three to four times daily. Q Under 7 years, not recommended; 7-12 years, v-1 three or four times daily. B Renal or hepatic impairment.
PANADOL
GSK
2 Analgesic. Paracetamol 500mg. White film-ctd cap.-shaped scored tab. marked PANADOL in blue both sides. 12, A1.16; 24, A2.00; 96, A5.01.
2 ALSO PANADOL SOLUBLE Paracetamol 500mg. White scored effervescent tab. 24, A3.03. S Analgesic and antipyretic. P 2 three or four times daily. Q Under 6 years, use elixir or Junior; 6-12 years, v-1 tab.
2
ALSO PANADOL EXTRA Paracetamol 500mg, caffeine 65mg. White cap.-shaped film-ctd tab. 12, A1.36; 24, A2.36. P 2 up to four times daily; max. 8 in twenty-four hours. Q Under 12 years, not recommended.
2 ALSO PANADOL BABY & INFANT Paracetamol 120mg/5ml. Strawberry flavoured sugar-free susp. 100ml, A2.52. P Up to 20ml four times daily. Q 3 months-1 year, 2.5-5ml; 1-6years, 510ml; 6-12years, same as adult. All four times daily. B Renal or hepatic impairment.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
139
4.1 PAIN,
ANALGESIA
PYREXIA
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. Max. 4 tabs. in 24 hours. Under 6 years: Tabs. not PARALINK Ricesteele recommended, use elixir. B Lactation (excreted in breast milk, 2K 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 impairment or alcohol dependence (caution). S Analgesic and antipyretic. Mild to moderate pain; for the relief of symptoms of colds C Other paracetamol-containing products (not recommended). Cholestyramine, warfarin, and influenza and to lower temperature. Q 3 months-1 year, 5ml. 1-5 years, 5-10ml. zidovudine, domperidone, metoclopramine. A Rashes, blood disorders and acute Over 6 years, 10-20ml. All 3 or 4 times daily. pancreatitis reported. 2KO
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 Johnâ&#x20AC;&#x2122;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, ALSO PARALINK SUPPOSITORIES Paracetamol PERFALGAN BMS mineralocorticoid hormones, nelfinavir, 180mg, 500mg. Suppos. 180mg-10, A4.42; 500mgzidovudine, fluconazole, desipramine, other 2JN 10, A5.38. centrally-acting agents (alcohol, barbiturates, Analgesic. Paracetamol 1g/100ml. Vial containing S Pain and fever associated with such neuromuscular blocking agents, phenothiazines 100 ml of soln. for infusion. 12, A54.72. conditions as influenza, common cold, headache, and tranquillisers, some psychotropic drugs). S Moderate pain (especially following rheumatism, teething and post operative A Confusion, dizziness, drowsiness, lightsurgery) and fever, when admin. by IV route discomfort. clinically justified and/or when other admin. routes headedness, GI disorders, sweating, urinary P 1-2 x 500mg six hourly. retention/hesitancy. not possible. Q 3 months-1 year (5-10kg body weight), P 15-min. IV infusion. More than 50kg: 1g v x 180mg. 1-3years (10-15kg body weight), 1 x Antigen up to 4 times a day. Less than 50kg: 15 mg/kg per PONALGIC 180mg. 3-6years (15-20kg body weight), 1v x 2MO admin. Max. daily dose: 60mg/kg, not exceeding 180mg. 6-12 years (20-90kg), 1 x 500mg. All 6 NSAID. Mefenamic acid 250mg. Yellow/blue cap. 4g. Minimum interval between each admin: 4 hourly. marked ANTIGEN and coded MA250. 100, A4.67; hours. Severe renal impairment, 6 hrs interval B Renal or hepatic impairment. 500, A23.81. minimum. Hepatocellular insufficiency, chronic A Rare but hypersensitivity incl. skin rash 2MO alcoholism, chronic malnutrition, dehydration: 3g may occur. Some reports of blood dyscrasias incl. thrombocytopoenia and agranulocytosis but not max daily. ALSO PONALGIC FORTE TABLETS Mefenamic acid necessarily causally related to paracetamol. Q More than 33 kg (approx. 11 years old), 500mg. Yellow film-ctd tab. marked with logo and as for adults weighing less than 50kg. coded MA500. 100, A9.31. PARAMOL Galen D Severe hepatocellular insufficiency. S Mild to moderate pain incl. headache, B Hepatocellular insufficiency, severe renal dental or post-op pain, rheumatic, muscular or 2NO arthritic pain. Primary dysmenorrhoea. insufficiency, chronic alcoholism, chronic Compound analgesic. Paracetamol 500mg, dihydrocodeine tartrate 10mg. White tab. marked malnutrition (low reserves of hepatic gluthatione), Dysfunctional menorrhagia. P 500mg three times daily. dehydration. Very serious liver damage risk at PARAMOL. 100, A2.45; 500, A11.64. Q Not recommended. doses higher than recommended. Pregnancy. S Mild to moderate pain. D Ulcerative lesions or inflammation of GI C Probenecid, salicylamide, enzymeP 1 four hourly during or after meals tract. Renal or hepatic impairment. Pregnancy, inducing substances, oral anticoagulants. increasing to 2 four times daily if necessary. lactation. Aspirin/NSAID induced bronchospasm, Q Not recommended. rhinitis or urticaria. PHYMET DTF GSK D Respiratory depression, obstructive B Elderly. Renal dysfunction. Regular airways disease. 0L surveillence if therapy is prolonged. Discontinue if B Allergic disorders. Renal or hepatic Opiate. Methadone HCl, 1mg/ml. Clear green liver dysfunction, rash, blood dyscrasias or impairment, hypothyroidism. Elderly. Pregnancy. viscous oral solution. diarrhoea occur. Cardiac or hepatic impairment. C Alcohol, CNS depressants. S Relief of severe pain in conditions History of peptic ulcer or inflamatory bowel A Constipation. Rarely nausea, headache. where morphine may be a reasonable alternative disease. Intracranial haemorrhage or bleeding See SPC. (severe cancer pain). diathesis. P Initially, 5-10mg admin. orally. Adjust C Anticoagulants, other plasma protein PARAPAED JUNIOR Pinewood according to individual response. Twice daily max. bound drugs. Antihypertensives, diuretics, 2 in chronic use. May be used in combination with cardiacglycosides, lithium, methotrexate, Analgesic. Paracetamol 120mg/5ml. Sugar-free non-narcotic analgesics. Renal impairment: cyclosporin, other NSAIDs, corticosteroids, susp. 140ml, A5.05. Caution. GFR 10-50ml/min, dosage interval 8 aminoglycosides, probenecid, oral hypoglycaemics. S Analgesic and antipyretic. hourly minimum; GFRQ10ml/min, dosage interval A GI disturbance, diarhoea, headache, Q Under 3 months, 2.5ml; 3 months-1 12 hourly minimum. Hepatic impairment: Use less bronchospasm, rash, renal dysfunction, year, 2.5-5ml; 1-6 years, 5-10ml; 6-12 years, 10than normal recommended dose, using patientâ&#x20AC;&#x2122;s thrombocytopenia and other blood dyscrasias. 20ml. All three or four times daily. response as guide. 2 R Careful monitoring advised. PONSTAN Chemidex ALSO PARAPAED SIX PLUS Paracetamol 250mg/ Q Not recommended. 2MO 5ml. Sugar-free susp. 70ml, A4.30. D Respiratory depression (esp. cyanosis, NSAID. Mefenamic acid 250mg. Ivory/blue cap. P 10-20ml four to six hourly; max. 4g excessive bronchial secretions), bronchial asthma marked PONSTAN 250. 100, A5.70; 500, A25.61. daily. attack, acute alcoholism, head injury, raised S Pain associated with rheumatic, Q Under 6 years, not recommended; 6-12 intracranial pressure, ulcerative colitis, severe years, 5-10ml four to six hourly; max. 2g daily. hepatic impairment, biliary and renal tract spasm, muscular or arthritic disorders, trauma, headaches, B Renal or hepatic impairment dental pain, post-operative or post-partum states. labour. Pyrexia in children. B May occur: Deaths due to cardiac PARATABS Pinewood arrhythmias and respiratory depression (caution 2MO 2K during dose initiation and adjustment period), QT ALSO PONSTAN FORTE Mefenamic acid 500mg. Yellow film-ctd tab. 100, A10.40. Analgesic. Paracetamol 500mg. White cap.-shaped interval prolongation and serious arrhythmia A A S Pain associated with rheumatic, (particularly at high doses; caution and careful tab., scored on one side. 12, 1.10; 24, 1.55. muscular or arthritic disorders, trauma, headaches, S Management of symptoms of headache, monitoring of patients at risk of prolonged QT dental pain, post-operative or post-partum states. interval, known history, advanced heart disease, toothache, common cold, influenza, menstrual pain and musculo-skeletal disorders. P Daily dose, 1500mg in divided doses. ischaemic heart and liver disease, concomitant
A Skin rashes and other allergic reations occur occasionally. Haematological reactions have been reported.
140
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA 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.
PAIN, Q Under 7kg or under 6 months, not recommended. Pain and fever: 20mg/kg/day in divided doses. Infants 6-12 months: 2.5ml three times a day. 1-2 years: 2.5ml three to four times a day. 3-7 years: 5ml three to four times a day. 8-12 years: 10ml three to four times a day. D Peptic ulceration (or history). Patients in whom NSAIDs induce symptoms of asthma, rhinitis or urticaria. Severe hepatic/renal failure or HF. B Elderly. Use lowest effective dose. May cause dose dependent renal toxicity in at risk patients. Impaired renal/heart failure or liver dysfunction. Coagulation defects. Bronchial asthma or allergic disease. If symptoms persist q 3 days, consult your doctor. Do not exceed the stated dose. Pregnancy (avoid). C Avoid: Other analgesics. Caution: Antihypertensives, diurectics, cardiac glycosides, lithium, methotrexate, cyclosporin, mifepristone (or within 8-12 days), corticosteroids, anticoagulants, quinolone antibiotics. A GI disorders, peptic ulceration, GI bleeding.
PYREXIA
4.1
10, A2.52; 300mg-10, A2.85. S Antipyretic, analgesic and antiinflammatory agent in the management of mild to moderate pain, e.g. headache, toothache, rheumatism etc. P 600-900mg four to six hourly. D Known hypersensitivity to any of the ingredients. B Use in children, particularly under 12 years, should be avoided unless essential. Particular caution necessary in the presence of viral infections. C Anticoagulants, uricosurics, insulin A Bronchospasm, attacks of asthma in susceptible individuals.
SEVREDOL
Mundipharma
0LO
Opiate. Morphine sulph. 10mg, 20mg, 50mg. Blue, pink or green film-ctd cap.-shaped, scored tabs. marked IR and tab. strength. 10mg-56, A7.68; 20mg-56, A15.36; 50mg-56, A34.17. S Acute and chronic, severe pain. P Initially 10mg four hourly, then adjusted RANGABAX Ranbaxy according to response. The dosage can be 2MO increased under medical supervision according to the severity of the pain and the patient’s previous GABA analogue Gabapentin 100mg, 300mg, history of analgesic requirements. 400mg, 800mg. 100mg: White opaque hard cap. Q Under 3 years, not recommended; 3-5 (size 4) marked G100 on cap and body. 300mg: PRIALT Eisai years, 5mg four hourly; 6-12 years, 5-10mg four Ivory opaque hard cap. (size 0) marked G300 on 2NO hourly. cap and body. 400mg: Orange opaque hard cap. ++ D Pregnancy, lactation. Respiratory Ca channel blocker. Ziconotide (as ziconotide (size 0) marked G400 on cap and body. 800mg: A depression, obstructive airways disease. Acute acetate) 100mcg/ml. Sln for inf. 1ml, 339.29; 5ml, White to off-white, oval, biconvex film-ctd tab. hepatic disease. Acute alcoholism, head injury, A1,696.43. marked G800 on one side. 100mg-100, A14.48; coma, convulsive disorders, raised intracranial S Severe, chronic pain in patients who 300mg-100, A30.93; 400mg-100, A37.47; 800mgpressure. Paralytic ileus. require intrathecal (IT) analgesia. 100, A82.91. B Hypothyroidism, renal and chronic P Initially 2.4mcg/day. Titrate individually S Treatment of peripheral neuropathic hepatic disease. Elderly. Shock, adrenocortical in increments of R 2.4mcg/day up to 21.6mcg/day pain (e.g. painful diabetic neuropathy and postinsufficiency. (max). Min. interval between dose increases is 24 herpetic neuralgia ) in adults. C MAOIs, CNS depressants, hrs; recommended interval is r 48 hrs. P Initiate by dose titration: 300mg once Q Under 18 years, not recommended. daily on day 1, increasing to 300mg twice daily on phenothiazines, anaesthetics, hypnotics, alcohol. A Tolerance, dependence. Constipation, D Pregnancy, lactation (unless clearly day 2, then 300mg three times daily on day 3. nausea, vomiting. necessary). Alternatively initiate with 900mg/day given as 3 B Long-term use, systemic chemotherapy. equally divided doses. Thereafter, can be increased SOLPADEINE GSK Monitor: For meningitis; myopathy (creatine in 300mg/day increments every 2-3 days up to 2 kinase levels). Consider catheter tip placement 3600mg/day max. See SPC. Renal impairment, SOLPADEINE SOLUBLE TABLETS Compound carefully. Discontinue if signs/symptoms of haemodialysis: See SPC. analgesic. Paracetamol 500mg, codeine phos. 8mg, cognitive impairment or neuropsychiatric adverse R Adjust according to renal funtion. caffeine 30mg. White effervescent tab. 12, A2.46; reactions develop. Depressed levels of B Consider discontinuation if acute 24, A4.04; (GMS) 60, A6.89. consciousness, discontinue if occurs.May cause/ pancreatitis develops. Caution in patients with P 2, three or four times daily in water. worsen depression with risk of suicide in mixed seizures incl. absences. Assess risks/benefits susceptible patients. of prolonged therapy in children and adolescents. Q Under 7 years, not recommended. 7-12 years, v-1, three or four times daily. C Contra: IT chemotherapy. Caution: Monitor for signs of suicidal ideation and 2O Systemic chemotherapy, IT morphine, opiates, behaviours. False positives in dipstick tests (total systemic baclofen, clonidine, bupivacaine or urine protein). Withdraw gradually. Driving/ ALSO SOLPADEINE CAPSULES Paracetamol 500mg, propofol, CNS depressants. Partial opioid agonists, operating machinery. codeine phos. 8mg, caffeine 30mg. Red/white cap. no data. C Morphine (monitor for CNS depression). marked Solpadeine. 12, A1.92; (GMS)24, A1.79; A Anorexia, confusional state, psychiatric Antacids. (GMS)32, A3.03. disorders, dizziness, memory impairment, A Infections (e.g. viral, UTI, RTI, otitis P 2, three or four times daily. headache, eye disorders, vertigo, tinnitus, media, pneumonia), leucopenia, anorexia, Q Under 12 years, not recommended. hypotension, dyspnoea, GI disorders, sweating, increased appetite, psychiatric and nervous system 2 rash, pain, muscle disorders, arthralgia, urinary disorders, visual disturbances, vertigo, ALSO SOLPADEINE TABLETS Paracetamol 500mg, disorders, gait abnormal, fatigue, pyrexia, oedema hypertension, vasodilatation, dyspnoea, bronchitis, codeine phos. 8mg, caffeine 30mg. White cap. peripheral, rigors, fall, feeling cold, jittery. pharyngitis, cough, rhinitis, GI disorders, facial shaped tab. marked Solpadeine. 12, A2.18; 24, oedema, purpura, rash, pruritus, acne, arthralgia, A3.58. PROVIN McNeil Healthcare myalgia, back pain, twitching, incontinence, S Rheumatic and musculo-skeletal pain; impotence, fatigue, fever, peripheral or 2K headaches, sinusitis and influenza. generalised oedema, abnormal gait, asthenia, NSAID. Ibuprofen 100mg/5ml. Oral suspension. P 2, three or four times daily. pain, malaise, flu syndrome, decreased WBC, Sugar free, colour free and strawberry flavour. Q Under 12 years, not recommended. weight gain. A A 100ml- 3.12; 150ml- 4.38. D Lactation. S Mild to moderate muscular pain. B Renal or hepatic impairment. Patients RESPRIN Ricesteele Headache, earache, dental pain and backache. on salt restriction. 2KO Minor injuries such as sprains and strains. C Alcohol or CNS depressants may Feverishness and symptoms of colds and influenza. Salicylate. Aspirin 150mg, 300mg. Suppos. 150mg- increase any sedative effect. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
141
4.1 PAIN,
ANALGESIA
PYREXIA 400mg-56, A8.47.
one 200mg twice daily. Swallowed whole. Total daily dose of q 400mg not usually required. Q Under 12 years, not recommended. D Pregnancy (unless benefit outweighs Carbamazepine 100mg/5ml. Sugar-free liquid. 2NO risk), lactation. Severe renal impairment (ccQ10ml/ A 300ml, 7.27. Compound analgesic. Paracetamol 500mg, codeine S Trigeminal neuralgia and other forms of min). phos. hemihydrate 30mg. White effervescent B Caution: Head injury, increased deafferentation pain. scored tab. 100, A11.56. intracranial pressure, severe hepatic impairment, P Initially 100mg once or twice daily 2NO biliary tract disorders, patients prone to increasing gradually to control, usually 600-800mg ALSO SOLPADOL CAPLETS Paracetamol 500mg, convulsions or in shock, respiratory depression. daily. Max. 1.6g daily. codeine phos. 30mg. White cap.-shaped tab. Contains lactose. Not suitable as a substitute in Q Not applicable. marked SOLPADOL. 100, A9.32. opiate-dependent patients. Driving/operating 2 M O S Severe pain. machines. ALSO TEGRETOL RETARD Carbamazepine 200mg P 2 tabs four hourly; max 8 in 24 hours. C Acute intoxication with alcohol or other beige-orange cap.-shaped scored controlledR Dose may need to be reduced. CNS agents, MAOIs (or within 2 weeks of release Divitab marked H/C one side and C/G on Q Under 12 yrs, not recommended. reverse; 400mg brown-orange cap.-shaped scored withdrawal), under general anaesthesia. Caution: D Respiratory depression, acute asthma, controlled-release Divitab marked CG/CG one side CNS depressants, antipsychotics known to induce acute alcoholism, head injury, raised intracranial and ENE/ENE on reverse. 200mg-50, A4.76; 400mg- convulsions, TCAs, SSRIs, carbamazepine, pressure, following biliary tract surgery, patients cimetidine. 50, A9.37. currently receiving or within 14 days of stopping A Nausea, vomiting, dry mouth, dizziness, P Same total daily dose as above but in MAOI. Pregnancy, lactation. drowsiness, sweating, headache, flushing, fatigue, two divided doses. B Severe renal or hepatic impairment. dependence. Prostatic hypertrophy, inflammatory or obstructive Q Not applicable. D AV conduction abnormalities unless bowel disorders. Elderly. Concurrent CNS TRAMAKE Galen paced. depressant drugs. Prolonged use. Tolerance and 2NO B Severe cardiac disease, renal or hepatic dependence. Withdrawal symptoms may occur. impairment. Perform liver function tests Opiate analogue. Tramadol (HCl) 50mg, 100mg. Driving/operating machinery. Overdose. periodically. Blood dyscrasias. Pregnancy, lactation. White scored tabs. marked T50 or TRAMAKE 100. Effervescent tabs contain sorbitol. Test blood regularly. 50mg-100, A14.20. 100mg-60, A17.05. C Chloramphenicol, oral contraceptives, C MAOIs, anticoagulants, antiepileptics, S Treatment and prevention of severe metoclopramide, domperidone, colestyramine, lithium, macrolide antibiotics (erythromycin), some pain. warfarin and other coumarins. Alcohol. Avoid Ca++ antagonists (verapamil, diltiazem), P 50-100mg 4-6 hourly. Max. 400mg daily. other paracetamol containing products. dextropropoxyphene, viloxazine, cimetidine, Q Not recommended. A Codeine: Constipation, nausea, isoniazid, oral contraceptives, alcohol. D Pregnancy, lactation. vomiting, dizziness, light-headedness, confusion, A Gastric upset, diplopia, dry mouth, B Elderly. Severe renal or hepatic drowsiness and urinary retention. Paracetamol: impairment. Head injury, raised intracranial Skin rash, blood dyscrasias, thrombocytopenia and drowsiness and dizziness. Oedema and hyponatraemia. Blood dyscrasias, rashes, acute pressure. Previous history of convulsions. agranulocytosis. Pancreatitis very rarely. renal failure, hepatitis. See SPC. Respiratory depression. SYNDOL SSL Healthcare C Alcohol, CNS depressants, MAOIs, TRADOL Rowex carbamazepine. 2 A Nausea, vomiting, dry mouth, 2NO Compound analgesic/antihistamine. Paracetamol drowsiness, fatigue, dizziness, rash, diaphoresis, Opiate analgesic. Tramadol (HCl) 50mg. Green/ 450mg, codeine (phos.) 10mg, doxylamine hallucinations, confusion, headache. Rarely, A (succinate) 5mg, caffeine 30mg. Yellow scored tab. yellow cap. 100, 12.10. cardiovascular effects, respiratory depression, 2NO marked S. 10, A2.53; 20, A3.93. convulsions, dependence, dysphoria, blood ALSO TRADOL EFFERVESCENT Tramadol (HCI) S Tension headache. Relief of pain dyscrasias. 50mg. White scored effervescent tab. 50, A9.44. following surgical and dental operation and P Depending on severity of pain, initially procedures. TRAMAPINE Pinewood 50-100mg followed by 50-100mg at 4-6 hrly P 1-2 tabs. 4 to 6 hourly. Max. 8 tabs. in 2NO intervals. Acute pain, initially 100mg. Chronic 24 hours. conditions, initially 50mg. Max. 400mg daily. Q Under 12 years, not recommended. 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, B Do not take other paracetamol containing products. Not to be taken continuously hrly intervals. A12.96. 2NO over long periods. S Management (treatment and C Alcohol. ALSO TRADOL INJECTION Tramadol (HCI) 50mg/ prevention) of severe pain. A Drowsiness, constipation. ml, 50mg/2ml. Amps. 50mg/ml-5, A2.16; 100mg/ P Depending on the severity of the pain, 2ml-5, A4.32. initial dose 50-100mg every 4-6 hours. Acute pain, TEEDEX Ricesteele P Usually initial bolus of 100mg by IM or initial dose 100mg. Chronic conditions, initial dose 2K slow IV inj. followed by 50-100mg at 4-6 hrly 50mg. Max. daily dose 400mg. intervals. Total daily dose q 400mg not usually Q Under 1 year, not recommended. 1-14 Analgesic/antihistamine. Paracetamol 120mg, years, 1-2mg/kg body weight at 4-6 hourly. diphenhydramine (HCl) 12.5mg per 5ml. Clear red required. Max. 600mg. May be diluted in soln. or admin by inf. or Patient Controlled Analgesia 2NO oral soln with raspberry odour. 100ml, A2.98. (PCA). S Teething pains, irritability associated ALSO TRAMAPINE PROLONGED RELEASE Q See lit. with injections or feverishness, aches or pains, Tramadol (HCI) 100mg. Prolonged-release off2NO colds and flu, associated sleeplessness. See Dozol white, round biconvex tab. 60, A16.73. in same section for prescribing information. 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 TEGRETOL Novartis prolonged release bi-layer tab. Initial layer white; twice daily if necessary. Leave a min. interval of 8 2MO 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 Dibenzazepine. Carbamazepine 100mg white A34.79. sufficient liquid. scored tab. marked B/W on one side and GEIGY S Treatment and prevention of moderate R As per adults. Over 75 years, elimination on reverse; 200mg white scored tab. Marked C/G to severe pain. may be prolonged. on one side and G/K on reverse; 400mg white P Depending on severity of pain. Usual Q Under 12 years, not recommended. oblong tab. scored and marked CG/CG one side D Uncontrolled epilepsy. Pregnancy, and scored with tab. name on reverse. 100mg-100, initial dose one 100mg tab. twice daily, morning A4.16. 200mg-100, A7.69. 400mg-50, A7.57; and evening. May be increased to one 150mg or lactation. A Constipation.
2MO
SOLPADOL
142
sanofi-aventis ALSO TEGRETOL ORAL SUSPENSION
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 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.
PAIN, 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.
PYREXIA
4.1
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.
ZAMADOL SR
Meda
2MO
Opiate analogue. Tramadol (HCl) 50mg, 100mg, 150mg, 200mg. Hard prolonged release caps. Dark green marked T50SR, white marked T100SR, dark green marked T150SR and yellow marked T200SR resp. 50mg-60, A10.17; 100mg-60, A19.38; 150mg60, A29.08; 200mg-60, A38.76. VEGANIN PLUS Chefaro S Severe pain. P Initially, 50-100mg twice daily; may be 2 Compound analgesic. Paracetamol 500mg, codeine titrated up to 150-200mg twice daily. Max. 400mg. Treatment should be short and intermittent phos. 8mg, caffeine 30mg. White, film-ctd. cap.(dependence). shaped tab. debossed on one side with PCC. 10, R Over 75 years, adjust dosage. A1.92; 20, A3.28. TRAMIL Wyeth Healthcare Q Under 12 years, not recommended. Over S Mild to moderate pain, rheumatism, 2K 12 years, as per adults. dysmenorrhoea, symptomatic relief of colds and Analgesic/xanthine. Paracetamol 500mg, caffeine 2MO influenza. 32mg. Yellow/blue cap. marked TRAMIL. 10, P 2 with water every 4-6 hours. Max. 8 in ALSO ZAMADOL CAPSULES Tramadol (HCl) 50mg. A1.35. 24 hours. White, opaque, oblong hard gel. cap. marked T50. S Mild to moderate pain, pyrexia. Q Under 12 years, not recommended. 50mg-100, A12.16. P 1-2 four hourly as necessary. Max. 8 in D Acute asthma, respiratory depression, S Treatment and prevention of severe 24 hours. acute alcoholism, head injuries, raised intracranial pain. Q Under 12 years, not recommended. pressure, biliary tract surgery. P Acute pain: Initially 100mg then 50mg D Children Q12 years. B Severe renal/hepatic impairment. or 100mg r 4 hours apart. Duration should be B Renal or hepatic impairment. Do not Elderly. Prostatic hypertrophy, inflammatory or matched to clinical need. Pain associated with take with other paracetamol containing products. obstructive bowel disorders. chronic conditions: Initially 50mg, then titrate Do not exceed stated dose. Prolonged use may be C CNS depressants, metoclopramide, according to pain severity. Regularly assess need harmful. domperidone, cholestyramine, warfarin, for continued treatment. Max. 400mg daily. Severe C Cholestyramine. Metoclopramide, anticonvulsants, oral contraceptives, alcohol, hepatic impairment/renal insufficiency (ccQ30 ml/ domperidone. Warfarin. Chloramphenicol. barbiturates, MAOIs (or within 2 weeks of min): 12 hourly. A Skin rash, GI disturbances, tremor, treatment cessation), antidiarrhoeal/antiperistaltic R Over 75 years, adjust dosage. palpitations. Rarely: Thrombocytopenia purpura, agents, antimuscarinics, quinidine, mexiletine, Q Under 14 years, not recommended. Over methaemoglobinaemia, agranulocytosis. cimetidine. 14 years, as per adults. A Skin rash, constipation, drowsiness, D Uncontrolled epilepsy, narcotic TRANSTEC Mundipharma headache, tremor, nervousness, irritability. withdrawal treatment. Pregnancy, lactation. 0LO B Tendency to drug abuse or dependence. XYMEL 50 Clonmel Can induce convulsions. History of epilepsy or Opiate. Buprenorphine 35mch/hour, 52.5mcg/hour, 70mcg/hour over a period of 96 hours. patients susceptible to seizures; only if essential. 2NO Transdermal patches. 35mcg/hour-4, A39.73; Hypersensitivity to opiates. Renal/hepatic Opiate analogue. Tramadol (HCl) 50mg. Green/ 52.5mcg/hour-4, A59.60; 70mcg/hour-4, A79.46. impairment (not recommended if severe), head yellow cap. marked TRA 50. 100, A11.13. injury, decreased level of consciousness, increased S Moderate to severe cancer pain and S Management (treatment and intracranial pressure, shock, respiratory depression, severe pain that does not respond to non-opioid prevention) of severe pain. analgesics. P 1-2 four to six hourly. Max. 400mg daily. excessive bronchial secretion. Mild anaesthesia, not recommended. Driving/using machines. P The lowest dose providing adequate Q Under 1 year, not recommended; 1-14 C Contra: Acute intoxication with pain relief should be given. Initially 35mcg/hour years, 1-2mg/kg body weight four to six hourly. hypnotics, centrally acting analgesics, opioids, and titrate individully replacing every 96 hours. 2NO psychotropic drugs, alcohol; MAOIs (within 2 Patients requiring a suppl.ary analgesic may take ALSO XYMEL PROLONGED RELEASE TABLET weeks). Mixed agonist-antagonists, eg. 1-2 x 0.2mg buprenorphine sublingual tabs. every Tramadol (HCl) 100mg. Prolonged-release white, buprenorphine, nalbuphine, pentazocine (avoid). 24 hours in addition to the patch. round, film ctd tab. 60, A16.32. Q Under 18 years, not recommended. P Initially 100mg twice daily morning and Caution: CNS depressants, SSRIs, TCAs, antipsychotics, other seizure threshold lowering drugs, D Opioid dependence, severe respiratory evening. May titrate up to 150 or 200mg twice carbamazepine, courmarin derivatives. impairment, MAOIs, myasthenia gravis, delirium daily if necessary. Doses q 400mg daily, not A Fatigue, dizziness, headache, confusion, tremens. Pregnancy, lactation. usually required. Swallow tab. whole with GI disorders, pruritis, urticaria, skin rashes, B Alcohol intoxication, impaired sufficient liquid. hallucinations, dysphoria, dependence, abuse, respiratory function, hepatic impairment. Ability to Q Under 12 years, not recommended. withdrawal reactions. operate machinery may be impaired. D Lactation. C MAOIs, CNS depressants. B Drug dependence may occur. Not ZYDOL SR Grunenthal Pharma A Nausea, dizziness, tiredness, vomiting, suitable as a substitute in opioid-dependent constipation, diaphoresis, dyspnoea, erythema, 2NO patients. Head injury, increased intracranial pruritus, headache. Opiate analogue. Tramadol (HCl) 50mg, 100mg, pressure, severely impaired liver or kidney 150mg, 200mg. Yellow, white, peach and orange function, convulsive disorders, respiratory TYLEX UCB film-ctd sust.-release tabs. marked T0, T1, T2 or T3, depression or shock. Avoid during light planes of 2NO and with logo. 50mg-60, A7.41; 100mg-60, general anaesthesia. Driving or operating Compound analgesic. Paracetamol 500mg, codeine machinery, if drowsiness occurs. Pregnancy (unless A16.80; 150mg-60, A25.21; 200mg-60, A33.61. phos. 30mg. White/red cap. marked C30. 24, S Treatment of moderate to severe pain. benefit outweighs risk). AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
143
4.2 MIGRAINE
ANALGESIA
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.
one side. 50mg-100, A3.51; 100mg-100, A6.52. 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.
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 2NO YE7 and 100 resp. 50mg-2, A9.77; 6, A29.29; 100mg-2, A17.23; 6, A51.68. ALSO ZYDOL CAPSULES Tramadol (HCl) 50mg DIXARIT Boehringer Ing. A Green/yellow cap. 100, 13.00. P Single 50-100mg dose at onset of attack. Patients who do not respond should not S Treatment of moderate to severe pain. 2MO P Initially 1 or 2 caps., then 1 or 2 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 more frequently than four hourly; max. 8 daily. ctd tab. 112, A7.85. hrs. Max. 300mg in 24 hours. Q Under 1 year, not recommended; over 1 S Prophylaxis of migraine or recurrent W Over 65 years or under 18 years, not year, see below. vascular headache. Menopausal flushing. recommended. 2NO P 2-3 morning and evening. D Ischaemic heart disease, severe hepatic ALSO ZYDOL INJECTION Tramadol (HCl) 50mg/ml. Q Not recommended. impairment, previous myocardial infarction, A 2ml amp. 5 x 2ml, 6.24. B Depressive illness. Lactation. coronary vasospasm (Prinzmetal’s angina), S Treatment of moderate to severe pain. C Anti-hypertensives. peripheral vascular disease, history of P 50-100mg by IM or IV inj. 4 to 6 hourly; A Sedation, dry mouth, dizziness, cerebrovascular accident (CVA) or transient max. 600mg daily. sleeplessness. ischaemic attack (TIA), diabetes, uncontrolled Q Q1 year, not recommended; q1 year, 1FROVEX A. Menarini hypertension. 2mg/kg body weight every 4-6 hours. B Hypertension, patients predisposed to 2NO 2MO thrombotic episodes (patients receiving HRT), risk ALSO ZYDOL XL Tramadol (HCl) 150mg. White 5HT receptor agonist. Frovatriptan (succinate factors for coronary artery disease; assess patients prolonged release, film-ctd tab., marked T 150. 30, monohydrate) 2.5mg. Biconvex, white film-ctd. before initial therapy. History of epilepsy, hepatic A17.61. tab. debossed M one side and 2.5 the other. 6or renal impairment. Overuse of acute migraine S Management (treatment and 2.5mg, A29.50; 2-2.5mg, A9.83. treatments associated with exacerbation of prevention) of severe pain. S Acute treatment of headache phase of headache in susceptible patients; withdrawal of P 1 tab. daily, increase if necessary. Take migraine attacks, with or without aura. Not for treatment may be necessary. Pregnancy, lactation. at 24-hourly intervals and swallow whole. Over prophylaxis. Driving or operating machinery. 400mg daily, not usually required. P All adults, 2.5mg. If migraine recurs C MAOIs, other acute migraine therapies, Q Over 12 years: As per adults. Under 12 after initial relief a second dose of 2.5mg may be 5HT re-uptake inhibitors, lithium, ergotamine (all years: Not recommended. given; interval between doses, 2 hours min. contraindicated). D Epilepsy not adequately controlled by R Over 65 years, insufficient data to A Transient pain, sensation of heaviness, treatment. Not for use in narcotic withdrawal recommend. pressure or tightness, fatigue, dizziness, treatment. Pregnancy, lactation. Q Not recommended. drowsiness, weakness. Increase in BP, flushing, B May cause physical dependence. Not a D History of MI, ischaemic heart disease, dyspnoea. substitute in opioid-dependent patients. History of coronary vasospasm (Prinzmetal’s angina), addiction or dependence. Hypersensitivity to peripheral vascular disease, hypertension IMITAG Pinewood codeine, respiratory depression. Head injuries, (moderate/severe or uncontrolled mild), previous 2MO raised intra-cranial pressure, severe hepatic or CVA or TIA, severe hepatic impairment. renal impairment, in shock, epilepsy or patients B Not indicated for hemiplegic, basilar or 5-HT agonist. Sumatriptan (succinate) 50mg, prone to convulsive disorders. Contains lactose. 100mg. Pink/white resp. oval-shaped biconvex ophthalmoplegic migraine. Not for prophylaxis. tabs. 50mg tab. is scored. 50mg-6, A18.46; 100mgDriving, using machines. Cardiac disease, hypertension, predisposition to 6, A32.93. C Contra: MAOIs (or within 2 weeks), thrombotic episodes (HRT), Pregnancy, lactation. other centrally acting drugs, including alcohol. Driving/operating machinery. Hereditary galactose S Acute migraine attacks, with or without aura. Caution: SSRIs, TCAs, carbamazepine, antiintolerance, Lapp lactase deficiency, glucoseP Single 50-100mg dose at onset of psychotics, ritonavir, digoxin, other morphine galactose malabsorption. attack. Patients who do not respond should not derivatives, benzodiazepines, barbiturates, mixed C Other acute migraine therapies, take 2nd dose for same attack. If symptoms recur agonists/ antagonists, anticoagulants, lithium, 5HT ergotamine/ergotamine derivatives (incl. in patients who respond, repeat dose 1 or 2 times or NA potentiating anti-depressants. methysergide), other 5-HT1 receptor antagonists, after min. 2 hrs. Max. 300mg in 24 hours. MildA Dizziness, headache, somnolence, MAOIs, St John’s wort (hypericum perforatum), moderate liver impairment: Consider 25mg-50mg. sweating, nausea, vomiting, dry mouth, SSRIs, methylergomatrine, gluvoxamine, oral W Over 65 years or under 18 years, not constipation, fatigue. contraceptives. recommended. A Dizziness, headache, somnolence, 4.2 MIGRAINE D MI, ischemic heart disease (or symptoms/ parasthesia. Nausea, dry mouth, dyspepsia, signs), coronary vasospasm (Prinzmetal’s angina), abdominal pain, skeletal pain. Fatigue, sensation BETA-PROGRANE Tillomed peripheral vascular disease. History of of abnormal temperature, flushing, chest pain, cerebrovascular accident or transient ischemic 3MO palpitation, throat tightness. attack. Severe hepatic dysfunction, moderate or Non-cardioselective b-blocker. Propranolol (HCl) GSK severe hypertension or mild uncontrolled 80mg, 160mg. White hard prolonged.-release cap. IMIGRAN NASAL SPRAY hypertension. 160mg-28, A8.13; 80mg (HALF BETA-PROGRANE)- 2 M O B Not indicated for basilar, hemiplegic or 28, A6.27. 5-HT agonist. Sumatriptan 10mg, 20mg/0.1ml. ophthalmoplegic migraine. Exclude neurological S Prophylaxis of migraine. Single dose nasal spray. 10mg-2, A12.90; 6, conditions. Patients at risk of ischaemic heart P 80mg every morning or evening; may A38.48; 20mg-2, A15.39; 6, A46.17. disease (e.g. diabetics, heavy smokers, patients on be increased if necessary to 160mg daily up to S Acute migraine attacks, with or without nicotine substitution, postmenopausal women and 240mg daily. aura, unresponsive to conventional therapy. Not menq40 with risk factors). History of seizures. Q Not recommended. to be used prophylactically. Hepatic/renal insufficiency. Hypersensitivity to D See 2.4, b-blockers Drug Presc. Notes. P Optimal dose, 20mg dose into one sulphonamides. Controlled hypertension. Overuse. nostril at onset of attack; 10mg effective in some Contains lactose. Pregnancy, lactation. Driving, BETALOC AstraZeneca patients. If migraine recurs in patients who using machines. 3MO respond, repeat dose at minimum interval of 2 C Contra: Ergotamine (take sumatriptan Cardioselective b-blocker. Metoprolol tartrate. hours. Max. 40mg in 24 hours (in 2 x 20mg doses). 24 hours after ergotamine and ergotamine 6 50mg white tab. scored and marked A/BB one Patients who fail to respond initially should not hours after sumatriptan) MAOIs. Caution: SSRIs, triptans, lithium, St. John’s Wort. side; 100mg white tab. scored and marked A/ME receive a second dose for same attack.
144
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANALGESIA 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 INDERAL LA AstraZeneca after min. 2 hrs. Max. 300mg in 24 hrs. W Over 65 years or under 18 years, not 3MO recommended. Non-cardioselective b-blocker. Propranolol (HCl) D Severe hepatic impairment, ischaemic 160mg. Lavender/pink sust.-release cap. marked heart disease, previous MI. Coronary vasospasm INDERAL LA. Lavender/pink hard prolong.-release (Prinzmetal’s disease), peripheral vascular disease, cap. marked INDERAL LA. 28, A8.41. diabetics, uncontrolled hypertension. History of 3MO cerebrovascular accident or transient ischaemic ALSO HALF-INDERAL LA Propranolol (HCl) 80mg. attack (TIA). Lavender/pink hard prolong.-release cap. marked B Not indicated for basilar or hemiplegic/ HALF-INDERAL LA. 28, A6.13. ophthalmoplegic migraine. Exclude neurological S Migraine prophylaxis. conditions. Migraine patients are at higher risk of P 80-160mg daily. Max. 240mg daily. stroke and TIA. Underlying cardiac disorders; Q Not recommended. patients at risk of coronary artery disease or 3MO thrombotic episodes. Symptoms consistent with ALSO INDERAL TABLETS Propanolol (HCl) 10mg. angina, interrupt until further investigated. Pink film-ctd tab. marked Inderal 10. 10mg-100, Caution: Controlled hypertension, hepatic/renal A1.20. impairment. History of seizures. Hypersensitivity to P 40mg two or three times daily. Max. sulphonamides. Contains lactose. Pregnancy, 160mg/day. lactation. Driving/using machines. Q Under 12 years, half adult dose. C Contra: Ergotamine (take sumatriptan D See 2.4, b-blockers Drug Presc. Notes. 24 hrs after ergotamine and ergotamine 6 hrs Tabs contain lactose. after sumatriptan) MAOIs. Caution: SSRIs, lithium, triptans, St. John’s Wort, HRT. METOCOR Rowex A Tingling, dizziness, increases in BP, 3MO flushing, nausea, vomiting, sensations of Cardioselective b-blocker. Metoprolol tartrate heaviness/heat, pain, pressure or tightness, 50mg, 100mg. White tabs. scored one side. 50mg- weakness, fatigue. 100, A3.50; 100mg-100, A6.50. NARAMERG Teva S Migraine prophylaxis. P 100-200mg daily in divided doses. 2MO Q Not recommended. 5-HT receptor agonist. Naratriptan 2.5mg (as HCl) D See 2.4, b-blockers Drug Presc. Notes. Green, biconvex, round, film-ctd tab. debossed with NT 2.5 on one side. 6, A26.40; 12, A52.80. METOP Gerard S Acute treatment of headache phase of 3MO migraine attacks with or without aura. Cardioselective b-blocker. Metoprolol tartrate P 1 tab. To be taken as early as possible 50mg, 100mg. White tabs. Both marked ml and after onset of migraine headache, but effective if strength one side, G on reverse. 50mg-100, A3.50; taken at later stage. If symptoms recur following 100mg-100, A6.51. initial response, a 2nd dose may be taken S Migraine prophylaxis. (minimum 4-hour interval between doses). Max: 2 P 100-200mg daily in divided doses. tab. in any 24-hour period. If patient does not Q Not recommended. respond to 1st dose, a 2nd dose should not be D See 2.4, b-blockers Drug Presc. Notes. taken for same attack. Subsequent migraine attacks may be treated. Not for prophylactic use. MIGRALEVE McNeil Healthcare Mild-moderate renal/hepatic impairment, maximum total daily dose: 1 tab. 2 R Over 65 years, not recommended. Analgesic/antihistamine. Pink tabs: buclizine (HCl) Q Not recommended. 6.25mg, paracetamol 500mg, codeine phos. 8mg. D Previous MI, ischaemic heart disease, Yellow tabs: paracetamol 500mg, codeine phos. Prinzmetal’s angina/coronary vasospasm, 8mg. Both film-ctd tabs marked mgE. Duo-pack: peripheral vascular disease, symptoms or signs 12, A4.88; 24, A8.44; 48, A9.37; Pink: 12, A5.07; consistent with ischaemic heart disease. History of 24, A9.31; Yellow: 12, A4.38. cerebrovascular accident or transient ischaemic S Migraine. attack. Moderate or severe hypertension, mild P 2 pink tabs. at onset of attack. If uncontrolled hypertension. Severely impaired renal symptoms persist 2 yellow tabs. every four hours. (cc Q15 ml/min) or hepatic function (Child-Pugh Max. 2 pink and 6 yellow in 24 hours. grade C). Pregnancy (unless benefit outweighs Q Under 10 years, not recommended; 10risk), lactation (avoid for 24h). 14 years, half adult dose. B Use only with a clear diagnosis of B Renal or hepatic impairment. migraine. Not indicated for hemiplegic, basilar or A Drowsiness. ophthalmoplegic migraine. Exclude other potentially serious neurological conditions. Safety MIGRASTAT Gerard and efficacy during aura phase not established. 2MO Cardiac evaluation prior to treatment: Risk factors 5-HT agonist. Sumatriptan (succinate) 50mg, for ischaemic heart disease incl. heavy smokers or 100mg. Pink/white resp. round tab. marked SU50 users of nicotine substitution therapy (particularly or SU100 on one side and G on reverse. 50mg-2, postmenopausal women and males q 40 years). A6.16; 100mg-2, A10.98. Serious cardiac events may also occur in the S Acute migraine attacks (with or without absence of underlying CVD. Discontinue and A Tingling, dizziness, drowsiness, transient increase in BP, flushing, nausea, vomiting, sensation of heaviness, pain, heat, pressure or tightness, feelings of weakness, fatigue.
MIGRAINE 4.2 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.
PARAMAX
sanofi-aventis
2MO Analgesic/anti-emetic. Paracetamol 500mg, metoclopramide (HCl) 5mg. White round scored tab. marked PARAMAX. 14, A1.44. S Symptoms of pain, nausea and vomiting associated with a migraine attack. P Over 20 yrs: 2 tabs. at onset of migraine, thereafter 2 tabs at 4-hourly intervals (max 6 in 24-hrs). 15-20 yrs: 1-2 at onset (max 5 in 24 hrs). Severe renal impairment: Reduce to 1/3 of usual daily dose. Moderate renal impairment/ severe hepatic impairment: Reduce to v of usual daily dose. Q 12-14 yrs: 1 tab. at onset of migraine (max 3 in 24 hrs). Under 12 yrs, not recommended. D Gastro-intestinal haemorrhage, obstruction or perforation. Post-operative period. History of neuroleptic or metoclopramide induced tardive dyskinesia. Epilepsy. Phaeochromocytoma. B Parkinson’s disease, history of atopy (incl. asthma), porphyria. Neuroleptic Malignant Syndrome. Extrapyramidal disorders. Severe impaired renal or hepatic function. Methemoglobinemia. C Contra: Levodopa. Alcohol, chloramphenicol, oral contraceptives, domeperidone, colestyramine, warfarin/coumarins, anticholinergics, CNS depressants, neuroleptics, digoxin, cyclosporine. Avoid other paracetamol containing products. A Extrapyramidal reactions. Drowsiness, confusion, hallucination. Skin rash. Asthenia. Anxiety, depression. Diarrhoea. Amenorrhea, galactorrhea, gynaecomastia.
RELPAX
Pfizer
2MO 5-HT receptor agonist. Eletriptan 40mg (as hydrobromide). Round, convex, orange film-ctd tab. debossed with REP 40 one side and Pfizer the other. 6, A27.34. S Acute treatment of the headache phase of migraine attacks, with or without aura. P Initially, 40mg. If headache recurs within 24 hours, repeat dose at minimum interval of 2 hours. Non responsive patients should not take 2nd dose for same attack. If no satisfactory efficacy obtained after appropriate trial of 40mg, 80mg dose (2 x 40mg) may be taken for subsequent attacks. Max daily dose: 80mg. R Over 65 years, not recommended. Q Not recommended. D Severe hepatic/renal impairment. Moderately severe or severe hypertension, or untreated mild hypertension. Confirmed coronary 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
145
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AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
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 without prior evaluation if unrecognised cardiac disease likely, or in patient at risk of coronary artery disease. Slight and transient increases in BP may occur at doses q60mg (esp. renally impaired and elderly). Excessive use of any anti-migraine medicine can lead to daily chronic headaches requiring therapeutic window. Contains lactose and sunset yellow. C Contra: Potent CYP3A4 inhibitors; ergotamine or its derivatives (including methysergide) within 24 hours before or after treatment; other 5-HT1 receptor agonists. Caution: SSRIs, SNRIs, St. John’s wort. A Pharyngitis, rhinitis, somnolence, headache, dizziness, tingling or abnormal sensation, hypertonia, hypoaesthesia, myasthenia, vertigo, palpitation, tachycardia, flushing, throat tightness, abdominal pain, nausea, dry mouth, dyspepsia, sweating, back pain, myalgia, sensation of warmth, asthenia, chest symptoms (pain, tightness, pressure), chills.
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.
RHEUMATOLOGY
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.
ZOMIG
AstraZeneca
2MO 5HT1 agonist. Zolmitriptan 2.5mg. Yellow film-ctd tab. 3, A14.62; 6, A29.26.
2MO
ALSO ZOMIG RAPIMELT Zolmitriptan 2.5mg. White, round, orodispersible tab marked Z on one side with a bevelled edge. 2, A9.76; 6, A29.26. S Acute treatment of migraine headache with or without aura. P Initially 2.5mg as soon as possible after the onset of an attack. If symptoms persist or return, a repeat dose may be given at an interval of at least 2 hrs. If the response is inadequate, TOPAMAX Janssen-Cilag increase to 5mg for subsequent attacks. Max. 10mg daily. Severe hepatic impairment, max. 5mg 2MO in 24 hours. Sulphamate. Topiramate 25mg, 50mg, 100mg, R Over 65 years, not recommended. 200mg. White, light yellow, yellow or salmon film- Q Under 18 years, not recommended. ctd tabs marked with TOP and tab. strength. D Uncontrolled hypertension, MI, 25mg-60, A26.55; 50mg-60, A43.62; 100mg-60, Prinzmetal’s angina, ischaemic heart disease or A77.85; 200mg-60, A146.35. peripheral vascular disease; concomitant admin. of SANOMIGRAN Novartis 2 M O ergotamine and other 5HT agonists; history of 2MO ALSO TOPAMAX SPRINKLE Topiramate 15mg, cerebrovascular accident or transient ischaemic 5-HT antagonist. Pizotifen (as hydrogen malate) 25mg. Sprinkle cap. 15mg-60, A22.44; 25mg-60, attack; cc q15ml/min. A33.65. 0.5mg ivory/yellow sug-ctd tab. marked SMG; B Exclude serious neurological conditions; 1.5mg ivory/yellow sug-ctd tab. marked SMG and S Migraine prophylaxis in adult patients Wolff-Parkinson-White syndrome; phenylketonuria 1.5. 0.5mg-60, A5.25; 1.5mg-28, A8.76. intolerant of or unresponsive to other migraine (Rapimelt only). Prolonged use. Pregnancy, D Pregnancy, lactation. treatments. lactation. Tab contains lactose. Orodispersible tab B Epilepsy. Glaucoma. Urinary retention. P Initially 25mg daily for 1 week, then contains aspartame. C MAOIs, CNS depressants, alcohol. increased by 25mg/day at 1-week intervals. C Ergotamine (interval of min. 24 hrs if A Drowsiness, weight gain. Dizziness, dry Recommended dose 100mg/day in 2 divided doses. taken together). Caution: Moclobemide, other mouth, nausea, constipation. CNS stimulation in Maximum 200mg/day. Tab. should not be broken. MAOIs, cimetidine, fluvoxamine, quinolones. SSRIs, children. Q Not recommended. SNRIs (serotonine syndrome reported). D Pregnancy (unless benefits outweigh A Abnormalities or disturbances of SIBELIUM Janssen-Cilag risks), lactation. sensation, dizziness, paraesthesia, somnolence, B Caution: Hepatic and moderate to warm sensation, palpitations, abdominal pain, 2MO ++ severe renal impairment. Patients at risk of nausea, dry mouth, vomiting, muscle weakness, Selective Ca entry blocker. Flunarizine 5mg. Dark nephrolithiasis; maintain adequate hydration. May myalgia, asthenia, heaviness in limbs, chest and A grey body with red cap. 20, 10.41. neck; tightness in throat, neck, limbs and chest; S Prophylaxis and treatment of migraine. occur: increased incidence of mood disturbances pain or pressure in throat, jaw, neck and chest. P 1 twice daily or 2 at bedtime. Elderly, 1 and depression, acute myopia with secondary angle-closure glaucoma (rare). Monitor serum at night. 5.1 PAIN AND INFLAMMATION OF bicarbonate; reduce dose or withdraw if metabolic Q Not recommended. acidosis develops. Monitor for weight loss. MUSCULO-SKELETAL SYSTEM D Patients with current depressive illness Hereditary problems of galactose intolerance, the or with a history of recurrent depression. Lapp lactase deficiency or glucose-galactose ADVIL LIQUIGELS Wyeth Healthcare Pregnancy. malabsorption. Driving/using machine. Withdraw B Drowsiness may occur, and patients 2K gradually. should not drive or operate machinery. NSAID. Ibuprofen 200mg. Green translucent, oval C Caution: Phenytoin, carbamazepine, C Antihypertensives. soft gelatin cap. marked Advil one side in white digoxin, oral contraceptives, lithium, A Fatigue. Rarely depression and ink. 20, A3.20. hydrochlorothiazide, metformin, pioglitazone, extrapyramidal reactions. S Mild to moderate pain (rheumatic/ glibenclamide, agents causing nephrolithiasis. muscular pain, backache, headache, dental pain, SUMATRAN Rowex A Nasopharyngitis, anaemia, anorexia, dysmenorrhoea), feverishness, cold and flu decreased appetite, depression, abnormal 2MO symptoms. behaviour, aggression, agitation, anger, anxiety, 5-HT agonist. Sumatriptan (succinate) 50mg, bradyphrenia, confusional state, depressed mood, P 1-2 caps. every 4-6 hours. Max. 6 in 24 100mg. Pink/white resp. biconvex oblong scored hours. disorientation, expressive language disorder, tab. 50mg-2, A6.15; 50mg-6, A18.45; 100mg-2, Q Under 12 years, not recommended. insomnia, altered mood, mood swings, dizziness, A10.97; 100mg-6, A32.90. parathesia, somnolence, amnesia, balance disorder, D Aspirin/NSAID induced allergies. Peptic ulcer, other GI disorders. Pregnancy (1st and 3rd S Acute migraine attacks, with or without cognitive disorder, convulsion, abnormal trimester). aura. coordination, attention disturbance, dysarthria, B Asthma, cardiac/renal/hepatic P Single 50-100mg dose at onset of dysgeusia, hypoaesthesia, intention tremor, attack. Patients who do not respond should not lethargy, memory impairment, mental impairment, insufficiency. Elderly. nystagmus, impaired psychomotor skills, sedation, C Other analgesics. Caution: Oraltake 2nd dose for same attack. If symptoms recur
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RHEUMATOLOGY
PAIN
A Anaemia, lightheadedness, headache, GI disorders, pruritus, rash, oedema.
anticoagulants, thiazide diuretics. A GI disturbances. Rash, pruritus. Easy bruising or bleeding. Abnormal liver function tests.
ARCOXIA 2MO
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
ARTHRIMEL
5.1
sug-ctd tabs marked BRUFEN 400; magenta oval film-ctd tab. marked BRUFEN 600. 400mg-250, A11.45; 600mg-100, A7.28.
Clonmel 2 M O
ALSO BRUFEN SYRUP Ibuprofen 100mg/5ml. 200ml, A1.90. P 1200-1800mg daily in three divided equiv. glucosamine sulfate 500mg. Off-white doses. Max. 2400mg daily. oblong film-ctd tab. 90, A21.32. Q 1-2 years, 2.5ml three or four times S Osteoarthritis of low to moderate daily; 8-12 years, 10ml three or four times daily. degree. (Based on 20mg/kg body weight daily). Dose P 1 three times daily. should not exceed 500mg in twenty four hours for Q Under 18 years, not recommended. children weighing less than 30kg. Juvenile B Allergy to shellfish. Contain lactose. rheumatoid arthritis, up to 40mg/kg body weight Severe renal/hepatic insufficiency. Pregnancy daily in divided doses. (avoid 1st 3 months), lactation; if benefit D Active peptic ulcer. outweighs risk. B Aspirin/anti-inflammatory induced C Caution: Hypoglycaemic agents. allergy. Asthma. Pregnancy. A Transient GI disorders, heartburn, C Caution: Antihypertensives, diuretics, nausea. cardiac glycosides, lithium, methotrexate, ARTHROTEC 50 Pfizer cyclosporin, other NSAIDs, corticosteroids, anticoagulants, anti-platelet agents, SSRIs, 2NO quinolone antibiotics, probenacid, oral Phenylacetic acid/prostaglandin analogue. hypoglycaemics, Ginkgo biloba extracts. Diclofenac (Na+) 50mg, misoprostol 200mcg. White A Dyspepsia, GI bleeding, rash, rarely tab. marked with symbol one side, Searle 1411 on thrombocytopenia. reverse. 60, A17.15.
2MO
MSD Amino-monosaccharide. Glucosamine sulfate NaCl
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 resp. one side and coded 101, 200, 202 and 204 resp. on reverse. 30mg-28, A29.68; 60mg, 90mg28, A31.49; 120mg-7, A7.88; 28, A31.49. S Symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS). P OA: 30mg once daily up to 60mg once daily. RA and AS: 90mg once daily. Hepatic insufficiency: mild, max. 60mg once daily; moderate, max. 60mg every other day. Q Under 16 years, not recommended. D Active peptic ulceration or GI bleeding, severe hepatic / severe renal dysfunction, IBD, severe CHF. Aspirin/ant-inflammatory induced asthma or allergies. Pregnancy or women attempting to conceive, lactation. B Renal or hepatic impairment. History of ischaemic heart disease, cardiac failure, LV dysfunction, hypertension, pre-existing oedema. History of GI perforation. Elderly. Dehydration. Monitor patients on anticoagulants. C Caution: Diuretics, ACE inhibitors, AIIAs, cyclosporin, tacrolimus, lithium, rifampicin, oral contraceptives, HRT, oral anticoagulants, high dose aspirin or other NSAIDs (avoid), methotrexate, digoxin, salbutamol, minoxidil. A Dizziness, headache, GI disorders, oedema, hypertension, asthenia/fatigue, flu-like disease.
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 ARELOGER Gerard effective contraception. Gastroduodenal ulceration, renal, cardiac or hepatic impairment. 2MO Monitor patients on long term therapy. NSAID. Meloxicam 7.5 mg, 15mg. Pale yellow Cerebrovascular, coronary or peripheral vascular round tabs. with score line on one side. 7.5mg-30, disease. A7.01; 15mg-30, A9.52. C Avoid: Other NSAIDs (incl. COX-2 S Short-term treatment of exacerbations inhibitors). Caution: Oral hypoglycaemics, K+of osteoarthrosis. Long-term treatment of rheumatoid arthritis (RA) or ankylosing spondylitis sparing diuretics, steroids, lithium, anticoagulants, methotrexate, ciclosporin, tacrolimus, digoxin, (AS). P Osteoarthrosis: 7.5mg/day as single dose ketoconazole, anti-hypertensives. Not to be taken for 8-12 days after mifepristone. Antacids may with water or other liquid during meal; may be delay absorption. increased to 15mg/day. RA/AS: 15mg/day; may be A GI upset, erosion. Insomnia, headache, reduced to 7.5mg/day. Max. 15mg/day. Dialysis dizziness, erythema multiforme, rash, pruritus, patients with severe renal failure: 7.5mg/day. increased blood alkaline phosphatase, increased R 7.5mg/day ALT. Q Under 15 years, not recommended. D Pregnancy, lactation. History of or active BRUFEN RETARD Abbott GI ulcer, severely impaired liver function, non2MO dialysed severe renal failure, GI/cerebrovascular NSAID. Ibuprofen 800mg. White pillow-shaped, bleeding or other bleeding disorders, severe film-ctd sust.-release tab. marked BRUFEN RETARD. uncontrolled HF. B History of oesophagitis, gastritis and/or 56, A13.89. peptic ulcer, GI symptoms or history of GI disease. S Rheumatoid arthritis (incl. Still’s disease), Bronchial asthma. Elderly, cardiac failure, cirrhosis, ankylosing spondylitis, osteoarthritis, sero-negative arthropathies, peri-articular disorders, soft tissue nephrotic syndrome or renal failure, major surgery; monitor diuresis and renal function. May injuries. P 2 as a single dose, preferably in the impair women fertility. Contains lactose. early evening, swallowed whole with plenty of C Not recommended: Other NSAIDs, fluid. In severe or acute conditions, max. 3 daily in lithium, oral anticoagulants. Caution: Thrombolytics and antiplatelet drugs, diuretics, AII two divided doses. Q Under 12 years, not recommended. receptor antagonists, ACE inhibitors, b-blockers, 2MO cyclosporin, intrauterine devices, glucocorticoids, ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta methotrexate, cholestyramine.
CAPRIN
Pinewood
2MO Salicylate. Aspirin 300mg. Pink ent-ctd tab. marked CAPRIN. 100, A3.72. S Rheumatic and associated conditions. 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, A1.90 ; 50mg-30, A3.69. S All grades of pain and inflammation incl. acute musculo-skeletal disorders. P 100-150mg in two or three divided doses. Max. 150mg daily. Q Under 14 years, not recommended; over 14 years, 75-100mg in two or three divided doses. D Active or suspected peptic ulcer. Asthma, aspirin/anti-inflammatory induced allergy. B Renal, cardiac or hepatic impairment. Elderly. Pregnancy, lactation. C Lithium, digoxin, anticoagulants, antidiabetic agents, cyclosporin, methotrexate, quinolone antimicrobials, other NSAIDs, corticosteroids, diuretics. A Epigastric pain, nausea, headache, dizziness, rash, elevation of liver enzymes.
CELEBREX
Pharmacia
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
147
5.1 PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
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. 100mg-60, A26.85; 100mg-100, A44.74; 200mg-30, A26.85; 200mg-100, A89.51. S Symptomatic relief in osteoarthritis or rheumatoid arthritis. P Osteoarthritis: 200mg once daily or in two divided doses; 200mg twice daily may be used. Rheumatoid arhtritis: 200-400mg in two divided doses. Max. 400mg daily. Q Not recommended. D Active peptic ulceration or GI bleeding, IBD, severe CHF, severe hepatic disease, aspirin/ anti-inflammatory induced asthma or allergy. Patients with estimated cc Q 30ml/min. Pregnancy and women of childbearing potential unless using an effective method of contraception, lactation. Hypersensitivity to sulphonamides. B Renal or hepatic impairment, cardiac failure, LV dysfunction hypertension, pre-existing oedema, risk of hypovolaemia. History of GI ulceration or inflammation. Elderly (q 65 years) and black patients should use lower dose. Advise women of childbearing age to use effective nonhormonal contraceptive measures. Monitor patients on anticoagulants. C Drugs metabolised by CYP2D6 or CYP2C19, diuretics, antihypertensives, ACE inhibitors, cyclosporin, tacrolimus, lithium, fluconazole, rifampicin, carbamazepine, barbiturates, fluconazole. No data with oral contraceptives. A Abdominal pain, diarrhoea, dyspepsia, flatulence, dizziness, peripheral oedema, fluid retention, insomnia, pharyngitis, rhinitis, sinusitis, upper respiratory infection, rash.
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. Crohnâ&#x20AC;&#x2122;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.
RHEUMATOLOGY
2MO 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, A3.00; 50mg-56, A7.26. 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, A2.30. 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. Phenylacetic acid. Diclofenac (sodium) 50mg. Tan P 1 once daily. circular biconvex ent.-ctd tab. engraved 50/0519 Q Not applicable. on one side. 100, A14.41. 2MO 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, pain. dysmenorrhoea, dental and minor surgery. P 75-150mg daily in 2-3 divided doses P 1 twice daily. swallowed with liquid before meals Q Not applicable. Q 1-3mg/kg body weight daily in divided 2NO doses. ALSO DIFENE INJECTION Diclofenac Na+ 25mg/ml. DICLAC Rowex 2MO 3ml amp. 10 x 3ml, A5.60. 2MO S Acute back pain, post-operative pain, ALSO DICLO 75 PROLONGED RELEASE Diclofenac Phenylacetic acid. Diclofenac (Na+) 25mg, 50mg. renal colic. (sodium) 75mg, prolonged release. Round flat Yellow-brown ent-ctd tabs. 25mg-100, A5.37; P 75mg IM once or twice daily by deep two-layered pink and white, prolonged release 50mg-100, A12.92. A intragluteal inj. for max. 2 days. Post operative tabs. 75mg Prolonged Release-60, 15.20. S Musculo-skeletal disorders, rheumatoid pain: Admin. 75mg IV diluted in 300ml normal S Osteoarthritis, pain/inflammation arthritis, osteo-arthrosis, ankylosing spondylitis, saline and infuse over min. 30 mins.; a second associated with musculo-skeletal disorders acute gout. Chronic juvenile arthritis. dose can be given 8 hours later; max. 2 inf. in 24 (rheumatoid arthritis, ankylosing spondylitis, Management of post-operative pain and hrs. Continue if necessary with tabs. or suppos. psoriatic arthropathy, periarthritis, tendinitis, inflammation in orthopaedic, dental and minor tenosynovitis, bursitis). Trauma and post-operative Q Not applicable. surgery. Dysmenorrhoea and associated D History of GI bleeding or perforation, pain. Dysmenorrhoea. menorrhagia. related to previous NSAID therapy. Active, or P 1 or 2 tabs. daily, taken whole with P 100-150mg daily in divided doses. Max. liquid. history of, recurrent peptic ulcer/haemorrhage. total daily dose should not exceed 150mg. Aspirin/anti-inflammatory induced allergy. Severe Q Not recommended. Q 1-3mg/kg body weight daily in divided D Active peptic ulcer, GI bleeding. Aspirin/ HF. In ulcerative or acute inflammatory conditions doses. of the anus, rectum (proctitis) and sigmoid colon. other non steroidal anti-inflammatory induced 2MO B Use lowest effective dose. Elderly. allergy. Pregnancy. ALSO DICLAC RETARD 75MG Diclofenac (Na+) History of GI disease/toxicity. Risk of GI bleeding, B Renal, severe hepatic or cardiac 75mg (12.5mg immediate release and 62.5mg ulceration or perforation. Risk of hypersensitivity insufficiency. Lactation. Elderly (prolonged use). prolonged release). Two layered, pink and white, reactions. May mask infection. Serious skin Anaphylactic reactions, discontinue if liver prolonged release tab. 60, A15.35. function worsens. Medical surveillance in patients reactions have been reported rarely. Renal, cardiac P 1-2 daily. or hepatic impairment. Bleeding abnormalities. with symptoms of GI disorders. Caution: Q Not applicable. Long-term use. May impair female fertility; not Intracranial haemorrhage and bleeding diathesis, 2MO recommended in women attempting to conceive. long term treatment. Avoid driving/operating Pregnancy, lactation. ALSO DICLAC RETARD 100MG Diclofenac (Na+) machinery if dizziness or other CNS disturbances C Lithium, digoxin, anticoagulants, anti100mg. White, round, prolonged release tab. 30, occur. A10.75. platelets, SSRIs, cyclosporin, methotrexate, C Lithium, digoxin, anticoagulants, quinolones, other NSAIDs and steroids, P 1 once daily. antidiabetic agents, cyclosporin, methotrexate, corticosteroid, diuretics, cardiac glycosides, antiQ Not applicable. quinolone antimicrobials, other NSAIDs, hypertensives, aminoglycosides, probenecid. 2MO corticosteroids, diuretics, salicylates, oral + A GI disorders, headache, dizziness, hypoglycemic agents, antihypertensives, cardiac ALSO DICLAC SUPPOSITORIES Diclofenac (Na ) vertigo, rashes or skin eruptions, raised ALT, AST. glycosides, aminoglycosides, probenecid. 100mg. 10, A2.30. P 1 at night alone or in combination with A GI disturbances, headache, dizziness, DONA Helsinn Birex vertigo, rash, elevated liver enzymes. oral admin. 2MO Q Not applicable. DIFENE Astellas Amino-monosaccharide. Crystaline glucosamine 2NO
148
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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
RHEUMATOLOGY
PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
5.1
initially 40mg as a single dose then 40mg daily in single or divided doses for next 4-6 days. Q Juvenile chronic arthritis (Still’s disease). 2MO Less than 15kg body weight, 5mg; 16-25kg body ALSO DONA CAPSULES Crystaline glucosamine weight, 10mg; 26-45kg body weight, 15mg; over sulphate 628mg (equiv. to glucosamine sulphate 500mg), Na+Cl- 128mg. Hard gelatine, snap-fit, red- 46kg body weight, 20mg. All as single daily dose. D Aspirin/anti-inflammatory induced red capsules, marked ROTTA on body and head. allergy. Active peptic ulcer, history of recurrent 90-A21.89. S Symptoms of osteoarthritis, i.e. pain and ulceration. B Impaired renal or hepatic function, function limitation. elderly. Intracranial haemorrhage and bleeding P Dissolve content of one sachet in glass of water, taken once daily, preferably at meal, or diathesis. History of upper GI disease. Interstitial one capsule three times daily, preferably at meals. nephritis, glomerulonephritis, papillary necrosis and nephrotic syndrome reported rarely. Monitor Max. recommended duration 3 years. patients with CHF, liver cirrhosis, nephrotic Q Not recommended. syndrome, overt renal disease and in long term D Lactation, pregnancy (unless benefit use. Pregnancy, lactation. Contains galactose. outweighs risk, avoid in first trimester). Sachets: Perform ophthalmic evaluation if visual Phenylketonuria (contains aspartame). complaints. B Impaired glucose tolerance (caution). C Warfarin, heparin; not recommended. Closer monitoring of blood sugar levels in Caution: Oral anticoagulants, anti-hypertensives, diabetics at start of treatment. Severe hepatic / diuretics, cardiac glycosides, lithium, methotrexate, renal insufficiency. Obtained from shellfish ciclosporin, NSAIDs, corticosteroids, (potential allergen). Contains sodium. Sachets aminoglycosides, probenecid, oral hypoglycemics, contain sorbitol. other protein-bound drugs. C Caution: Warfarin, tetracyclines. A GI disturbances, oedema, CNS effects, A Stomach pain, flatulence, diarrhoea, rash and pruritus. constipation, headache, somnolence, nausea, dyspepsia.
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.
DYNASTAT
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.
sulphate 1884mg (equiv. to glucosamine sulphate 1500mg), Na+Cl- 384mg. Sachets-30, A21.89.
2N
FENOPINE
Pinewood
Pharmacia 2 M O
NSAID. Ibuprofen 200mg, 400mg, 600mg. 200mg, 400mg: Pink, circular, film-ctd tab. marked IBU200 COX-2 inhibitor. Parecoxib 40mg per vial. After or IBU400. 600mg: Pink, biconvex, coated tab. reconstitution 20mg/ml. Powder for soln for inj. 200mg-100, A3.45; 500, A17.27; 400mg-100, Vials: 1 x 10, A83.28. A5.20; 500, A22.89; 600mg-100, A7.27. S Short term treatment of postoperative pain. S Various arthroses such as rheumatoid P 40mg IV or IM, followed every 6-12 arthritis (incl. Stills disease), osteoarthritis, hours by 20-40mg as required. Max. 80mg daily. fibrositis, ankylosing spondylitis, and other Q Under 18 years, not recommended. muscular syndromes such as low back pain, soft D Bronchospasm, acute rhinitis, nasal tissue trauma and various inflammations of the polyps, angioneurotic oedema, urticaria or tendon, joint capsules and ligaments. Mild to allergic-type reactions after taking acetylsalicylic moderate pain such as dysmenorrhoea, dental and acid or NSAIDs or other COX-2 inhibitors. Severe post-operative pain. hepatic impairment, active peptic ulceration or GI P 1200-1600mg daily in divided doses. bleeding, IBD, severe CHF. Women attempting to Max. daily dose: 2400mg. conceive. Third trimester of pregnancy, lactation. Q Body weight over 30kg, 20mg/kg daily B Impaired renal function, hypertension, in divided doses; 20-30kg, max. daily dose 400mg; compromised cardiac or hepatic function or other under 20kg, not recommended. conditions predisposing to fluid retention. D Hypersensitivity to aspirin or other Moderate hepatic impairment. Caution following NSAIDs. Active peptic ulceration or history of CABG surgery. History of upper GI perforations, severe ulceration. ulcers or bleeds (PUBS). B Renal, cardiac, hepatic impairment C Warfarin, diuretics, antihypertensives, (monitor renal function). Elderly (prolonged use ACE inhibitors, cyclosporin, tacrolimus, drug not recommended). Pregnancy. History or evidence metabolised by CYP2D6 or CYP2C19, lithium, of peptic or intestinal ulceration, asthma, fluconazole, rifampicin, carbamazepine, phenytoin. intracranial haemorrhage and bleeding diathesis, A Hypertension, hypotension, back pain, atopic patients or patients who have developed peripheral oedema, hypoaesthesia, alveolar osteitis bronchospasm with other NSAIDs. (dry socket), dyspepsia, flatulence, creatinine C Protein binding drugs incl. increase, hypokalaemia, agitation, insomnia, post- anticoagulants (warfarin, heparin), sulphonamides operative anaemia, pharyngitis, respiratory and hydantoins; caution. Enhance effects of insufficiency, pruritus, oliguria. Lithium. A GI disturbances. Headache, dizziness, FELDENE McNeil Healthcare vertigo, hearing disturbances, rash, oedema, blurred vision, hypersensitivity, haematuria or 2MO thrombocytopenia. NSAID. Piroxicam 10mg, 20mg. Red/blue cap. marked Pfizer and FEL 10. 10mg-30, A4.48; 10mgGERINAP EC Gerard 56, A7.43; 20mg-28; A7.43. 2MO S Rheumatoid arthritis, osteoarthrosis, Propionic acid. Naproxen 250mg, 500mg. White ankylosing spondylitis, acute musculo-skeletal film-ctd. tabs. 250mg-100, A5.19; 500mg-100, disorders, acute gout. Juvenile chronic arthritis. A10.40. P 20mg daily as a single dose. Acute musculo-skeletal disorders, initially 40mg daily for S Rheumatoid arthritis, osteoarthrosis, 2 days then 20mg daily for 7-14 days. Acute gout, spondylitis, acute gout. Juvenile rheumatoid
GLUCOSAMINE PHARMA NORD Pharma Nord
2MO
B Exclude presence of joint disease requiring alternative treatments. Diabetes (monitor more closely at start of treatment). Contains K+ (caution, patients on controlled K+ diet or with reduced kidney function). Hypercholesterolaermia (rare). A GI disorders, headache, tiredness.
MEFAC
Rowex
2MO NSAID. Mefenamic acid 250mg blue/white cap. marked MEFAC 250. 500mg yellow oval-shaped film-ctd tab. marked MEF 500. 250mg-100, A5.21; 500, A25.42; 500mg-100, A9.23. S Rheumatic, muscular or arthritic disorders incl. rheumatoid arthritis, Still’s disease and osteoarthritis. P 500mg three times daily. Q Not recommended. D Ulcerative lesions of GI tract. Pregnancy, lactation. Renal or hepatic impairment. B Elderly. Bronchial asthma and allergic disorders. C Anticoagulants. A Diarrhoea, skin rash, headache, bronchospasm, GI disturbance. Renal impairment. Thrombocytopenia.
MELCAM
Rowex
2MO NSAID. Meloxicam 7.5mg, 15mg. Pale yellow 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
149
5.1 PAIN
AND INFLAMMATION OF MUSCULO-SKELETAL SYSTEM
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, methotrexate, cholestyramine. A Anaemia, lightheadedness, headache, GI disorders, pruritus, rash, oedema.
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.
RHEUMATOLOGY
of the lower limbs.
MOBIGLAN
Niche
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 MELFEN Clonmel surgery; monitor diuresis and renal function. May MOBICAM Pinewood mask symptoms of underlying infectious disease. 2MO NSAID. Ibuprofen 200mg, 400mg, bright pink sug- 2 M O May impair women fertility. Contains lactose. ctd tabs. marked with logo and coded 178 or 179. NSAID. Meloxicam 7.5mg, 15mg. Pale yellow C Not recommended: Other NSAIDs, round tab. scored on one side. 7.5mg-30, A7.01; 200mg-100, A2.79; 400mg-100, A4.51; 250, lithium, oral anticoagulants. Caution: A11.23; 500, A22.06. 15mg-30, A9.82. Thrombolytics and antiplatelet drugs, diuretics, AII S Short-term symptomatic treatment of receptor antagonists, ACE inhibitors, b-blockers, S Rheumatoid arthritis, osteoarthritis, exacerbations of osteoarthrosis. Long-term cyclosporin, intrauterine devices, methotrexate, ankylosing spondylitis, acute articular and symptomatic treatment of rheumatoid arthritis cholestyramine. periarticular disorders, fibrositis, cervical (RA) or ankylosing spondylitis (AS). A Anaemia, lightheadedness, headache, GI spondylitis, low back pain, painful musculoP Osteoarthrosis: 7.5 mg/day. May be disorders, pruritus, rash, oedema. skeletal disorders. increased to 15 mg/day. RA and AS: 15mg/day. P 1200_1800mg daily in divided doses. Increased risks for adverse reactions, 7.5mg/day MOVOX Teva Max. 2400mg daily. initially . Dialysis patients with severe renal failure, 2 M O Q 20mg/kg body-wt. daily. Dose should not exceed 500mg daily for children weighing less max 7.5mg/day. round R Osteoarthritis: As per adults. RA and AS: NSAID Meloxicam 7.5mg, 15mg. Pale yellow A than 30 kg. tabs. with score line on one side. 7.5mg-30, 6.31; D Active peptic ulcer. Continuous use over 7.5mg/day. A8.84. 15mg-30, Q Under 15 years, not recommended. prolonged periods in the elderly. S Short-term treatment of exacerbations D Hypersensitivity to NSAIDs and aspirin. B Aspirin/anti-inflammatory induced of osteoarthrosis. Long-term treatment of Active GI ulcer or history of recurrent GI ulcer. allergies. Asthma. Pregnancy. Intracranial rheumatoid arthritis or ankylosing spondylitis. Severely impaired liver function. Non-dialysed haemorrhage, bleeding diathesis. P Exacerbations of osteoarthrosis: 7.5mg/ severe renal failure. GI bleeding, cerebrovascular C Oral anticoagulants, thiazide diuretics, day as a single dose with water or other liquid bleeding or other bleeding disorders. Severe HF. lithium. Anti-hypertensives diuretics, cardiac during meal; may be increased to 15mg/day. Severe CHF. Pregnancy, lactation. glycosides, methotrexate, cyclosporin, other B Uncontrolled hypertension, CHF, history Rheumatoid arthritis, ankylosing spondylitis: 15mg/ NSAIDs, corticosteroids, aminoglycosides, day; may be reduced to 7.5mg/day. Max. 15mg/ of oesophagitis, gastritis and/or peptic ulcer, GI probenecid, oral hypoglycaemic agents. day. Dialysis patients with severe renal failure: symptoms or history of GI disease, bronchial A Dyspepsia, GI bleeding, rash, rarely asthma. Monitor diuresis and renal function. May 7.5mg/day. thrombocytopenia. Headache, oedema, blurred R 7.5mg/day. occur: GI bleeding (withdraw), severe skin vision, hypersensitivity, abnormal liver function Q Under 15 years, not recommended. reactions (discontinue), interstitial nephritis, and renal impairment. D Pregnancy, lactation. History of or active glomerulonephritis, renal medullary necrosis or + GI ulcer, severely impaired liver function, nonnephrotic symptoms, Na and water retention, MOBIC Boehringer Ing. hyperkalaemia, transient increases in liver function dialysed severe renal failure, GI/cerebrovascular 2MO bleeding or other bleeding disorders, severe parameters, serum creatine and blood urea NSAID. Meloxicam 7.5mg, 15mg; pale yellow uncontrolled HF. nitrogen. May mask symptoms of underlying scored tabs. marked with company logo and B History of oesophagitis, gastritis and/or infectious disease. May impair fertility of women. coded 59D or 77C. 7.5mg-30, A7.02; 15mg-30, peptic ulcer, GI symptoms or history of GI disease. Contains lactose. A9.83. Bronchial asthma. Congestive cardiac failure, C Not recommended: Other NSAIDs, S Short term treatment of exacerbations cirrhosis, nephrotic syndrome or renal failure, lithium, oral anticoagulants, high dose of osteoarthritis. Long term treatment of major surgery; monitor diuresis and renal function. methotrexate, Caution: Thrombolytics and rheumatoid arthritis, ankylosing spondylitis. Elderly. Contains lactose. antiplatelet drugs, diuretics, aII receptor P Osteoarthritis: 7.5mg once daily, antagonists, ACE inhibitors, b-blockers, cyclosporin, C Not recommended: Other NSAIDs, increased if necessary to max. 15mg once daily. lithium, oral anticoagulants. Caution: glucocorticoids, intrauterine devices, Rheumatoid arthritis, ankylosing spondylitis: 15mg cholestyramine. Thrombolytics and antiplatelet drugs, diuretics, AII once daily. tab. should be taken with a meal. receptor antagonists, ACE inhibitors, b-blockers, A Anaemia, light-headedness, headache, GI disorders, pruritus, rash, oedema incl. oedema R 7.5mg once daily. cyclosporin, intrauterine devices, glucocorticoids,
150
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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
trimester of pregnancy. B Hypertension. Heart failure. Arterial thrombotic events. Cardiovascular disease. Oedema. GI toxicity. Visual disturbances. NAPROSYN EC Roche Impairment of female fertility. Serious skin reactions. Patients with intracranial haemorrhage 2MO and bleeding diathesis. Asthma. Elderly. Driving/ Propionic acid. Naproxen 250mg, 500mg. White operating machinery. ent-ctd tab. marked NAPROSYN EC one side, SYNTEX 250 on reverse and oblong white ent-ctd C Not recommended: Anticoagulants, antiplatelet agents, other NSAIDs, SSRIs, lithium, tab. marked NAPROSYN EC and SYNTEX. 250mgmethotrexate. Diuretics, pentoxifylline, 56, A5.20; 500mg-56, A10.41. corticosteroids, b-blockers, ACE inhibitors and S Rheumatoid arthritis, osteoarthrosis, angiotensin II antagonists, amino and cardiac ankylosing spondylitis, acute gout. P 500mg-1g daily in two divided doses 12 glycosides, cyclosporin, probenecid, thrombolytics, hourly or as a single dose morning or evening. 1g sulphonylureas. A GI intolerance, hypersensitivity reactions, daily should not be used for longer than 6 haematology disorders, headache, weight gain, months. taste perversion, tinnitus, dizziness, paresthesia, Q Juvenile rheumatoid arthritis only: convulsions, somnolence, mood disorders, oedema. Under 5 years, not recommended; 5-16 years, 10mg/kg body weight daily in two divided doses. D Active peptic ulcer or GI inflammation. OSTEOEZE Galen Aspirin/anti-inflammatory induced allergy. 2MO B Elderly. History of GI lesions. Renal or hepatic impairment. Asthma. Pregnancy, lactation. Amino-monosaccharide. Glucosamine HCI (equiv. C Anticoagulants, hydantoins, to 625mg glucosamine) 750mg. Yellow, oblong, sulphonylureas, lithium, b-blockers, methotrexate, film-ctd tab. printed with A. 60, A25.46. probenecid, frusemide. S Mild to moderate osteoarthritis. A Rash, GI intolerance, headache, tinnitus, P Initially 1 tab. twice daily. Clinical effect vertigo, blood dyscrasias. usually seen within 4 weeks. Once symptoms have been relieved, dose may be reduced to 1 tablet NU-SEALS 300 Alliance daily. Q Under 18 years, not recommended. 2MO D Allergy to shellfish. Salicylate. Aspirin 300mg. White ent-ctd tab. B Exclude presence of joint disease. marked 300 in red. 100, A4.76. Diabetes mellitus (monitor more closely at start of S Rheumatism, rheumatoid arthritis. treatment). Pregnancy, lactation; not P 300-900mg 3 or 4 times daily. Max. 8g recommended. daily. A Headache, drowsiness, dyspepsia, skin Q Under 16 years, not recommended. rash, pruritus, erythema. D Hypoprothrombinaemia, haemophilia, cerebral haemorrhage, active peptic ulceration, OSTEOLE Pinewood lactation. 2MO B Not for short-term pain relief. Renal, cardiac or hepatic impairment. May induce GI Amino-monosaccharide. Glucosamine sulfate haemorrhage. Long-term use, elderly; review 1500mg. White to slightly yellow crystalline regularly. Caution: History of IBD, coagulation odourless powder for oral solution. 30, A20.28. abnormalities. Hypertension, monitor. Pregnancy S Symptoms of osteoarthritis (i.e. pain and (avoid at term). function limitation). P 1 sachet once daily, preferably at meals. C AAvoid: Warfarin, heparin, other NSAIDs, antacids (simultaneous use). Caution: Anti- Safety and efficacy confirmed for treatment of up hypertensives, diuretics, cardiac glycosides, lithium, to 3 years. Q Safety and efficacy not established. methotrexate, ciclosporine, tacrolimus, D Phenylketonuria. corticosteroids, aminoglycosides, probenecid, oral B Renal or hepatic insufficiency: Admin hypoglycemics, anticoagulants, antiplatelets, under medical supervision. Caution: Shellfish fibrinolytics, carbonic anhydrase inhibitors, allergy. Contains sodium. ibuprofen. A Asthma, urate kidney stones, chronic GI C Warfarin. A GI disturbances. blood loss, tinnitus, nausea, vomiting. methotrexate, cholestyramine. A Anaemia, lightheadedness, headache, GI disorders, pruritus, rash, oedema.
ORUVAIL
sanofi-aventis
PONALGIC
Antigen
5.1
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
Meda
2MO Alkanone. Nabumetone 500mg. Red film-ctd tab. marked RELIFEX 500. 56, 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. C Caution: Oral anticoagulants, antihypertensives, diuretics, cardiac glycosides, lithium, methotrexate, ciclosporin, other NSAIDs, corticosteroids, aminoglycosides, progenicid, oral hypoglycemics, sulphonamines, hydantoins. A GI disorders including gastric ulcer and GI bleeding, headache, dizziness, confusion, sedation, hypersensitivity, anaphylaxis, angioedema.
SANDIMMUN
Novartis
2MT Fungal metabolite immunosuppressant. Cyclosporin 25mg pale pink oval cap., 50mg yellow oblong cap.; 100mg dusky pink oblong cap. 25mg-30, A29.01; 50mg-30, A53.77; 100mg-30, A105.50.
2NT
ALSO SANDIMMUN ORAL SOLUTION Cyclosporin 100mg/ml; oral soln. 50ml, A163.91. S Severe active rheumatoid arthritis refractory to other agents. V See lit. 2MO D Impaired renal function, uncontrolled ALSO PONALGIC FORTE TABLETS Mefenamic acid hypertension, uncontrolled infection. Malignancy. 500mg. Yellow film-ctd tab. marked with logo and B Monitor renal and liver function, BP and coded MA500. 100, A9.31. serum lipids. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. S Mild to moderate pain incl. headache, C Systemic antibiotics, live vaccines, dental or post-op pain, rheumatic, muscular or phenytoin, ketoconazole, fluconazole, arthritic pain. Primary dysmenorrhoea. itraconazole, erythromycin, rifampicin, Dysfunctional menorrhagia. carbamazepine, barbiturates, Ca++ antagonists, P 500mg three times daily. HMG-CoA reductase inhibitors, colchicine, Q Not recommended. D Ulcerative lesions or inflammation of GI nephrotoxic drugs, oral contraceptives,
2MO
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. 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
NSAID. Mefenamic acid 250mg. Yellow/blue cap. marked ANTIGEN and coded MA250. 100, A4.67; 500, A23.81.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
151
5.2 SEVERE
RHEUMATOLOGY
ACTIVE RHEUMATOID ARTHRITIS
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.
injury.
ARAVA
sanofi-aventis A Thrombocytopenia, proteinuria.
2NO
DMARD. Leflunomide 10mg white film-ctd tab. marked ZBN, 20mg yellow triangular film-ctd tab. marked ZBO, 100mg white film-ctd tab. marked ZBP. 10mg-30, A63.47; 20mg-30, A63.47;100mg-3, A31.73. S Active rheumatoid arthritis. P Loading dose 100mg once daily for 3 days. Maintenance, 10-20mg once daily. Q Under 18 years, not recommended. D Severe immunodeficiency, bone marrow dysfunction, blood dyscrasias, serious infections, hepatic or moderate to severe renal insufficiency, severe hypoproteinaemia, ulcerative stomatitsis. VOLTAROL Novartis Pregnancy; contraception must be used by men and women during and for 2 years after use or 2MO until plasma levels fall below 0.02 mg/l. Lactation NSAID. Diclofenac Na+ 25mg, 50mg. Yellow entctd tab. and brown ent-ctd tab. Both marked with B Use under specialist supervision. Monitor AST, ALT, BP before and regularly during tab. name and strength one side, GEIGY on reverse. 25mg-84, A8.64, 25mg-100, A5.38; 50mg- therapy. Take complete differential blood counts every 2 weeks for first 6 months, then every 8 50, A6.49. weeks. A washout procedure must be done if S Musculo-skeletal disorders, rheumatoid toxicity develops when switching to another arthritis, osteoarthritis, ankylosing spondylitis, DMARD or for a desired pregnancy; See SPC. acute gout. Chronic juvenile arthritis. Advise patient to report signs of infection. Dysmenorrhoea. C Other DMARDs, alcohol, hepatotoxic or P 75-150mg daily in 2 or 3 divided doses haematoxic drugs, methotrexate, drugs taken with liquid. metabolised by CYP2C9 (not NSAIDs), live vaccines, Q 1-3mg/kg body weight daily in divided cholestyramine, activated charcoal. doses. A Increased BP, GI upset, oral mucosal 2MO disorders, abdominal pain, altered liver function, ALSO VOLTAROL RETARD Diclofenac Na+ 75mg, leucopenia, tenosynovitis, headache, dizziness, 100mg. Pink triangular sust.-release tab. marked asthenia, paraesthesia, weight loss, allergy. Rarely, CG one side, ID on reverse and red sust.-release Stevens-Johnson syndrome, erythema multiforme. tab. marked VOLTAROL R one side, GEIGY on reverse. 75mg-30, A11.29; 100mg-28, A14.46; DISTAMINE Alliance 100mg-30, A15.48. 2MO P 1 x 75mg once daily or 1 x 75mg twice Penicillin deriv. Penicillamine base 125mg, 250mg. daily, alternatively 1 x 100mg once daily. Both White film-ctd tab. marked DS and 125 or DM and strengths taken whole at mealtime. 250. 125mg-100, A12.44; 250mg-100, A21.45. Q Use paed. suppos. S Severe active rheumatoid arthritis incl. 2MO juvenile forms. ALSO VOLTAROL SUPPS Diclofenac Na+ 100mg. P Initially 125-250mg daily for four weeks 10, A2.31. increasing by same amount at 4-12 week intervals P 1 at night. until remission. Usual maintenance, 500-750mg Q Use paed. suppos. daily. Max. 1.5g daily. 2MO R Initially 125mg (max) daily increasing to ALSO VOLTAROL PAED. SUPPS Diclofenac Na+ maintenance, max. 1g daily. 12.5mg. 10, 68c. Q Under 8 years, not recommended; 8 Q 1-3mg/kg body weight daily in divided years and over, 2.5-5mg/kg body weight daily for doses. one month increasing at four weekly interval; 2NO maintenance 15-20mg/kg daily. ALSO VOLTAROL INJECTION Diclofenac Na+ D Agranulocytosis or severe 75mg/3ml. Amp. 10 x 3ml, A5.61. thrombocytopenia due to penicillamine. Lupus S Acute back pain and trauma, posterythematosus. Lactation. Persistent proteinuria. operative pain, renal colic. Moderate/ severe renal impairment. Pregnancy. P 75mg IM once or in severe cases twice B Renal insufficiency. Monitor blood, daily by deep intra-gluteal inj. for max. of 2 days. urine and renal function before and frequently Q Not applicable. during treatment. Consider withdrawal if platelets D Active or suspected peptic ulcer. fall Q 120,000 or white blood cells Q 2,500/mm3, Asthma, aspirin/anti-inflammatory induced allergy. or if 3 successive falls noted within the normal B Renal, cardiac or hepatic impairment. range. Use antihistamines, steroid cover, or Elderly. Pregnancy, lactation. Recent proctitis. temporary reduction of dose to control urticarial C Lithium, digoxin, anticoagulants, reactions. Reversible loss of taste may occur. Stop antidiabetic agents, cyclosporin, methotrexate, treatment immediately if haematuria occurs in the quinolone antimicrobials, other NSAIDs, absence of renal stones or other known cause. A corticosteroids, diuretics. late rash may occur after several months or years A Epigastric pain, nausea, headache, of therapy (dose may need to be reduced). Breast dizziness, rash, elevation of liver enzymes. enlargement may occur in men and women. DMARDs linked with septic arthritis in RA patients. 5.2 SEVERE ACTIVE RHEUMATOID C Gold salts, anti-inflammatory, oral iron, ARTHRITIS drugs known to cause bone marrow or renal
152
ENBREL
Wyeth
2MT Tumour necrosis factor (TNF) antagonist. Etanercept 25mg, 50mg. 25mg: Vials containing powder and solvent for soln. for inj. or pre-filled syringe. 50mg: prefilled syringe. Prices available on request. S Adult rheumatoid arthritis (RA): When response to other agents incl. methotrexate (MTX) has been inadequate or patients not previously treated with MTX, in combination with MTX or as monotherapy where necessary. Polyarticular-course juvenile idiopathic arthritis in children (4-17 years) where MTX is ineffective or contraindicated. Adult psoriatic arthritis, adult severe active ankylosing spondylitis; when response to other agents has been inadequate. P 25mg SC twice weekly or 50mg SC once weekly. Q 4-18 years: 0.4mg/kg SC twice weekly (34 day interval between doses). D Sepsis or risk of sepsis. Active infections incl. chronic or localised infections. Treatment of Wegenerâ&#x20AC;&#x2122;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.
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 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.
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 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.
SEVERE
ACTIVE RHEUMATOID ARTHRITIS
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.
METHOTREXATE
NEORAL
5.2 Novartis
2MT
Fungal metabolite immunosuppressant. Cyclosporin 25mg blue-grey oval cap., 50mg yellow-white oblong cap.; 100mg blue-grey oblong cap. All marked with S in a triangle and cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; Goldshield 100mg-30, A96.03;
2NO
2MT
ALSO NEORAL ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A143.89. S Severe active rheumatoid arthritis refractory to other agents. P Initially 3mg/kg daily in two divided doses for 6 weeks. Increase gradually over next 6 weeks according to response; max. 5mg/kg daily in two divided doses. Q Not recommended. D Impaired renal function, uncontrolled hypertension, uncontrolled infection. Malignancy. B Only use under specialist supervision. Closely monitor renal and liver function, BP and METOJECT Fannin serum lipids, serum K+. Hyperkalaemia, 2NO hyperuricaemia. Pregnancy, lactation. Active Folic acid antagonist. Methotrexate (as herpes simplex infections should be cleared before methotrexate disodium) 10mg/ml. Sln for inj., pre- treatment. Not bioequivalent to Sandimmun; filled syringe. 10mg/1ml-1, A16.97; 10mg/1.5ml-1, specify brand when prescribing. KINERET Biovitrum A21.02; 10mg/2ml-1, A22.83; 10mg/2.5ml-1, C Systemic antibiotics, live vaccines, A23.36. phenytoin, ketoconazole, fluconazole, 2NT S Severe, active rheumatoid arthritis. itraconazole, erythromycin, rifampicin, Interleukin-1 receptor antagonist. Anakinra P Initially 7.5mg once weekly by SC, IM or carbamazepine, barbiturates, Ca++ antagonists, 100mg/0.67ml (150mg/ml). Soln. for inj. in preIV. May increase by 2.5mg/week up to 25mg/week HMG-CoA reductase inhibitors, colchicine, filled syringe. 28 pre-filled syringes, A1032.11. (max.). Expect response after 4-8 weeks. nephrotoxic drugs, oral contraceptives, S Treatment of signs and symptoms of Maintenance: Reduce gradually to lowest effective propafenone, prednisolone, methylprednisolone, rheumatoid arthritis (RA) in combination with dose. Renal impairment: cc: 20-50ml/min: 1/2 dose. K+suppl., K+sparing diuretics, lipid solutions, methotrexate in patients with inadequate R Consider dose reduction. NSAIDs, doxycycline, sulphadiazine, IV response to methotrexate alone. D Severe liver/renal insufficiency, alcohol sulphadimidine, IV trimethoprim, diclofenac, P 100mg once daily by SC inj. abuse, pre-existing blood dycrasias, severe acute/ nifedipine, grapefruit juice. R As for adults. chronic infections, oral cavity ulcers and known A Renal and hepatic dysfunction, Q Not recommended. active GI ulcer disease, pregnancy, lactation, hypertension, tremor, GI disturbances, D Pregnancy, lactation. Renal impairment. concurrent vaccination with live vaccines, hypertrichosis, gingival hypertrophy, malignancies, Hypersensitivity to E. coli derived proteins. immunodeficiency syndromes. lymphoproliferative disorders, burning sensations B Serious/chronic infections, neutropenia B Use under specialist supervision. Before (feet and hands), fatigue, muscle weakness or (ANC Q1.5x109/L, discontinue), cramp, myopathy. Rarely hyperkalaemia, use perform complete blood count, liver/renal immunosuppression, malignancy. Elderly. Live hyperuricaemia, hypomagnesaemia, function tests, chest x-ray. Exclude tuberculosis vaccines. Ensure adequate contraception. Needle hypercholesterolaemia, oedema, convulsions, and hepatitis. Dosesq20mg/week (risk of cover contains dry natural rubber. headache, rash, mild anaemia, haemolytic uraemic increased toxicity). During, regularly monitor: A Inj. site reactions, headache, syndrome, weight gain, pancreatitis, colitis, Mouth/throat for mucosal changes, blood count, neutropenia, serious infections (requiring paraesthesia, neuropathy, confusion, liver/renal function, respiratory system (risk of hospitalisation). dysmenorrhoea, amenorrhoea, gynaecomastia, interstitial pneumonitis often with eosinophilia, encephalopathy. fatalities reported). Discontinue/decrease dose MABTHERA Roche where necessary. If methotrexate induced lung ORENCIA BMS 2N disease suspected, treat with corticosteroids and Monoclonal antibody. Rituximab 10mg/ml. Soln. in discontinue. Caution: Inactive, chronic infections. 2N vial. 2x10ml, A653.14; 1x50ml, A1632.79. Risk of malignant lymphomas, discontinue if Immunosuppressant. Abatacept 250mg. Powder S In combination with methotrexate in occurs. Drain pleural effusions and ascites prior to for concentrate for soln for inf. 1, A439.43. adults with severe active rheumatoid arthritis use. If diarrhoea and ulcerative stomatitis occur S Moderate to severe active rheumatoid where other disease-modifying anti-rheumatic interrupt therapy. arthritis in combination with methotrexate in drugs (DMARDs) including one or more tumour C Alcohol, other hepatotoxics, retinoids, adult patients who have had an insufficient necrosis factor (TNF) inhibitor therapies are oral antibiotics (e.g. tetracyclines, response or intolerance to other DMARDs inappropriate. chloramphenicol), antibiotics (e.g. penicillines, including at least one tumour necrosis factor P 1 course: 1000mg by IV inf. followed by glycopeptides, sulfonamides, ciprofloxacin, inhibitor. 2nd 1000mg IV inf. two weeks later. 1st inf. rate: cefalotin), other protein bound drugs, probenecid, P Patients Q 60kg: 500mg (2 vials); 50mg/hr for 30 min increasing in 50mg/hr weak organic acids, NSAIDs, sulphasalazine, PPIs. patients r 60kg to R 100kg: 750mg (3 vials); increments every 30 min to max. 400mg/hr. 2nd Medicines that cause: Bone marrow depression; patients q100kg: 1,000mg (4 vials). Admin. as a inf: 100mg/hr for 30 min increasing in 100mg/hr folate deficiency. Products containing folic/folinic 30-minute IV inf. Following initial inf, admin. at 2 and 4 weeks, then every 4 weeks thereafter. If no increments at 30 min intervals to max. 400mg/hr. acid. Avoid: Excessive caffeine/theophylline response within 6 months, consider the potential Consider repeat course after benefit/risk containing beverages. benefits of continuing treatment. evaluation and with at least 16-week interval. A GI disorders, exanthema, erythema, Q Not recommended. Q Not recommended. pruritus, inj. site reactions, headache, tiredness, D Severe and uncontrolled infections such D Lactation, pregnancy (unless benefit drowsiness, pneumonia, interstitial alveolitis/ as sepsis and opportunistic infections. Pregnancy outweighs risk). Active, severe infections, severe pneumonitis often with eosinophilia, leukopenia, (unless clearly necessary), lactation. Women should HF or severe, uncontrolled cardiac disease. anaemia, thrombocytopenia. Elevated use contraception and not breast feed during B Inf. reactions (consider premedication transaminases. 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 intervals for 3 doses as a course once weekly. Max 20mg weekly. Psoriasis: 10-25mg orally once a week.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
153
5.3 PROPHYLAXIS
RHEUMATOLOGY
AND TREATMENT OF GOUT
treatment and up to 14 weeks after last dose. B History of recurrent infections or underlying conditions predisposing to infections. Monitor patients who develop a new infection during treatment; discontinue if serious. Screen for latent tuberculosis and viral hepatitis before initiating. Potential role in the development of malignancies is unknown. Do not admin. live vaccines during treatment or within 3 months of discontinuation. Use in elderly. Theoretically use might increase the risk for autoimmune processes. Allergic reactions may occur. Contains maltose (may interfere with the readings of blood glucose monitors). Contains 8.625mg Na+/vial. C Not recommended: TNF blocking agents and leflunomide. A BP increased, abnormal liver function tests, headache, dizziness, cough, abdominal pain, diarrhoea, nausea, dyspepsia, rash, lower and upper RTIs, UTIs, herpes simplex, rhinitis, hypertension, flushing, fatigue, asthenia.
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.
PLAQUENIL
;J
Sanofi
ROACTEMRA
5.3 PROPHYLAXIS AND TREATMENT OF GOUT
Roche
Interleukin inhibitor. Tocilizumab 20mg/ml. 2MO Concentrate for soln for inf. in vial. 80mg/4ml, A167.53; 200mg/10ml, A418.82; 400mg/20ml, Aminoquinoline. Hydroxychloroquine sulph. A837.65. 200mg white film-ctd tab. marked HCQ one side S Moderate to severe active rheumatoid and 200 on reverse. 60, A24.37. arthritis (RA) where DMARDs or TNF antagonists S Rheumatoid arthritis, juvenile ineffective or inappropriate, in combination with rheumatoid arthritis, lupus erythematosus. MTX or as monotherapy if MTX inappropriate. P Initially 400mg daily in divided doses P 8mg/kg body weight, but no lower than reducing to 200mg when no improvement is evident. Discontinue treatment after six months if 480mg, as IV infusion over an hour given once every four weeks. Doses above 1.2g have not been no improvement occurs. evaluated. Adjustment due to abnormalities in Q See literature. liver enzymes, neutrophil or platelet counts, see D Maculopathy. B Porphyria. Renal or hepatic impairment. SPC. Q Under 18 years, not recommended. History of GI, neurological or blood disorders. D Active, severe infections. Pregnancy Psoriasis. Perform regular eye tests before and (unless clearly necessary), lactation. Use during long-term therapy. Pregnancy, lactation. C Drugs causing ocular damage, antacids, contraception up to 6 months after treatment. B Moderate to severe renal impairment, aminoglycosides. monitor renal function. History of infections or A Retinal changes, corneal opacity. predisposing conditions (e.g. diverticulitis, Impaired visual accommodation (discontinue if diabetes), history of intestinal ulceration or occur). Skin reactions, bleaching of the hair, diverticulitis. Screen for TB prior to therapy. Active alopecia, GI intolerance. hepatic disease or hepatic impairment, ALT or AST REMICADE Schering-Plough q 1.5 x ULN (not recommended if q5; interrupt if q3-5). Monitor ALT and AST levels every 4-8 2N weeks for 1st 6 months and every 12 weeks Monoclonal antibody. Infliximab 100mg. Powder thereafter. Monitor neutrophils, platelets, lipid for conc. for soln in vial. 1, A690.43. parameters every 4-8 weeks. Increased risk of S Rheumatoid arthritis in combination malignancy, central demyelinating disorders. with methotrexate. Psoriatic arthritis (PA) in Contains Na+. combination with methotrexate or alone if C Live and live attenuated vaccines, other contraindicated/ intolerant. Severe active biological agents (not recommended). Caution: ankylosing spondylitis where conventional therapy CYP450 3A4, 1A2, 2C9 or 2C19. failed. A Upper RTIs, cellulitis, pneumonia, oral P RA: 3mg/kg, IV inf. over 2 hrs followed herpes simplex, herpes zoster, mouth ulceration, by additional 3mg/kg inf. at 2 and 6 weeks after gastritis, headache, dizziness, increased hepatic first inf., then every 8 weeks. Ankylosing transaminases/ bilirubin, hypertension, spondylitis, PA: 5mg/kg IV over 2 hrs followed by leucopoenia, neutropenia, hypercholesterolaemia. additional 5mg/kg inf. at 2 and 6 weeks after first inf. Then every 6-8 weeks for Ankylosing SALAZOPYRIN Pharmacia spondylitis; every 8 weeks for PA (if no response 2MO by 6 weeks, discontinue). Salicylate-sulphonamide. Sulphasalazine 500mg. Q Under 17 years, not recommended. Orange/yellow round tab. marked kPh one side D TB (must be screened for active/ and 101 on other. 112, A9.41. inactive), severe infections eg. sepsis, abscesses. Moderate/severe HF. Women should use adequate 2 M O ALSO SALAZOPYRIN SUSPENSION Sulphasalazine contraception and should not breastfeed during 250mg/5ml. Orange-lemon flavoured susp. 500ml, treatment and within 6 months of last dose. B Monitor for acute inf. reactions during/ A18.50. S Rheumatoid arthritis not responding to within a few hours of inf. If necessary interrupt NSAIDs. immediately. Ensure emergency equip. and 2MO treatment available. Monitor patients retreated
154
ALSO SALAZOPYRIN EN-TABS Sulphasalazine 500mg. Orange/yellow ent-ctd oval tab. marked KPh one side and 102 on reverse. 112, A13.27. P Initially 1 tab. or 10ml daily for one week, increasing by 1 or 10ml each week to max. 6 or 60ml daily in divided doses. Q Not recommended. 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.
ALOPUR
Rowex
2MO Xanthine oxidase inhibitor. Allopurinol 100mg, 300mg. White biconvex tab., round with singlesided score notch and oblong with both-sided breaking notch resp. 100mg-100, A6.45; 300mg100, A17.93. S Adults: Hyperuricaemia not controllable 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 hyperuricaemia. Adults and children: Secondary hyperuricaemia of differing origin. Adolescents and children: Uric acid nephropathy during treatment of leukaemia, hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome, adenine phosphoribosyl transferase deficiency. P Initially, low dosage eg. 100 mg/day with plenty of liquid after meal. Mild conditions, 100mg-200mg; moderately severe, 300mg-600mg; severe, 700mg-900mg daily. Or use 2-10mg/kg/day. Admin. dosage q 300mg in divided doses not exceeding 300mg at any time. Impaired renal or hepatic function: 300mg dose not suitable. Haemodialysis, 300mg-400mg immediately after every treatment session. Q 15kg and over, 10mg/kg daily (max. 400mg daily) given in 3 divided doses. Must use Alopur 100mg in children Q45kg. Under 15kg, contraindicated. D Lactation, pregnancy (unless explicitly necessary). Alopur 300mg: Severe renal dysfunction (ccQ20ml/min). B Hypersensitivity reactions, discontinue immediately. Monitor closely if impaired renal/ hepatic function or haematopoiesis disorders. Do not start until acute attack of gout completely subsided. Elderly. C Avoid ampicillin or amoxicillin. Caution: ACE inhibitors, diuretics, mercaptopurine, azathioprine, vidarabine, probenecid, salicylate, chlorpropamide, anticoagulants, phenytoin, theophylline, ciclosporin, didanosine, captopril. A Skin reactions.
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
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 resp. one side and coded 101, 200, 202 and 204 resp. on reverse. 30mg-28, A29.68; 60mg, 90mg28, A31.49; 120mg-7, A7.88; 28, A31.49. S Symptomatic relief of pain and signs of inflammation associated with acute gouty arthritis. P 120mg once daily, usually for 7 days. Hepatic insufficiency: mild, max. 60mg once daily; moderate, max. 60mg every other day. Q Under 16 years, not recommended. D Active peptic ulceration or GI bleeding, severe hepatic / severe renal dysfunction, IBD, severe CHF. Aspirin/ant-inflammatory induced asthma or allergies. Pregnancy or women attempting to conceive, lactation. B Renal or hepatic impairment. History of ischaemic heart disease, cardiac failure, LV dysfunction, hypertension, pre-existing oedema. History of GI perforation. Elderly. Dehydration. Monitor patients on anticoagulants. C Caution: Diuretics, ACE inhibitors, AIIAs, cyclosporin, tacrolimus, lithium, rifampicin, oral contraceptives, HRT, oral anticoagulants, high dose aspirin or other NSAIDs (avoid), methotrexate, digoxin, salbutamol, minoxidil. A Dizziness, headache, GI disorders, oedema, hypertension, asthenia/fatigue, flu-like disease.
PROPHYLAXIS AND 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
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. S Musculosketal disorders, 2MO 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. ALSO DIFENE INJECTION Diclofenac Na+ 25mg/ml. P 75-150mg daily in 2-3 divided doses, 3ml amp. 10 x 3ml, A5.60. with liquid before meals. R Lowest effective dosage in low BW frail S Acute back pain, post-operative pain, renal colic. patients. P 75mg IM once or twice daily by deep Q 1-3mg/kg body weight daily in divided intragluteal inj. for max. 2 days. Post operative doses. pain: Admin. 75mg IV diluted in 300ml normal 2NO ALSO DICLO 75 PROLONGED RELEASE Diclofenac saline and infuse over min. 30 mins.; a second dose can be given 8 hours later; max. 2 inf. in 24 (sodium) 75mg, prolonged release. Round flat hrs. Continue if necessary with tabs. or suppos. two-layered pink and white, prolonged release Q Not applicable. tabs. 75mg Prolonged Release-60, A15.20. D History of GI bleeding or perforation, S Acute gout. related to previous NSAID therapy. Active, or P 1 or 2 tabs. daily, taken whole with history of, recurrent peptic ulcer/haemorrhage. liquid. Aspirin/anti-inflammatory induced allergy. Severe Q Not recommended. D Active peptic ulcer, GI bleeding. Aspirin/ HF. In ulcerative or acute inflammatory conditions DICLAC Rowex of the anus, rectum (proctitis) and sigmoid colon. other non steroidal anti-inflammatory induced 2MO B Use lowest effective dose. Elderly. allergy. Pregnancy. + History of GI disease/toxicity. Risk of GI bleeding, Phenylacetic acid. Diclofenac (Na ) 25mg, 50mg. B Renal, severe hepatic or cardiac ulceration or perforation. Risk of hypersensitivity Yellow-brown ent-ctd tabs. 25mg-100, A5.37; insufficiency. Lactation. Elderly (prolonged use). reactions. May mask infection. Serious skin 50mg-100, A12.92. Anaphylactic reactions, discontinue if liver S Acute gout. function worsens. Medical surveillance in patients reactions have been reported rarely. Renal, cardiac or hepatic impairment. Bleeding abnormalities. P 100-150mg daily in divided doses. Max. with symptoms of GI disorders. Caution: Long-term use. May impair female fertility; not total daily dose should not exceed 150mg. Intracranial haemorrhage and bleeding diathesis, recommended in women attempting to conceive. Q Not applicable. long term treatment. Avoid driving/operating Pregnancy, lactation. 2MO machinery if dizziness or other CNS disturbances C Lithium, digoxin, anticoagulants, antioccur. ALSO DICLAC RETARD 75MG Diclofenac (Na+) platelets, SSRIs, cyclosporin, methotrexate, C Lithium, digoxin, anticoagulants, 75mg (12.5mg immediate release and 62.5mg quinolones, other NSAIDs and steroids, antidiabetic agents, cyclosporin, methotrexate, prolonged release). Two layered, pink and white, corticosteroid, diuretics, cardiac glycosides, antiquinolone antimicrobials, other NSAIDs, prolonged release tab. 60, A15.35. hypertensives, aminoglycosides, probenecid. corticosteroids, diuretics, salicylates, oral P 1-2 daily. A GI disorders, headache, dizziness, hypoglycemic agents, antihypertensives, cardiac Q Not applicable. vertigo, rashes or skin eruptions, raised ALT, AST. glycosides, aminoglycosides, probenecid. 2MO A GI disturbances, headache, dizziness, ALSO DICLAC RETARD 100MG Diclofenac (Na+) GERINAP EC Gerard vertigo, rash, elevated liver enzymes. 100mg. White, round, prolonged release tab. 30, 2MO A10.75. DIFENE Astellas Propionic acid. Naproxen 250mg, 500mg. White P 1 once daily. 2MO film-ctd. tabs. 250mg-100, A5.19; 500mg-100, Q Not applicable. A10.40. 2MO Phenylacetic acid. Diclofenac Na+ 25mg, 50mg. S Acute gout. Blue/transparent cap. containing ent-ctd pellets, ALSO DICLAC SUPPOSITORIES Diclofenac (Na+) marked D25 and blue/transparent cap. containing P 750mg initially, then 250mg eight 100mg. 10, A2.30. hourly. P 1 at night alone or in combination with ent-ctd pellets, marked D50. 25mg-56, A3.00; Q Not applicable. 50mg-56, A7.26. oral admin. D Peptic ulcer disease, active peptic ulcer, S Musculo-skeletal disorders, rheumatoid Q Not applicable. intestinal inflammatory disease. Hypersensitivity to arthritis, osteo-arthrosis, ankylosing spondylitis, 2NO naproxen. Aspirin/NSAID induced allergy. acute gout. Chronic juvenile arthritis. ALSO DICLAC INJECTION Diclofenac (Na+) 25mg/ B Elderly. History of GI disease. Renal or P 75-150mg daily in three divided doses. ml. 3ml amp. 10 x 3ml, A5.61. hepatic impairment. Asthma, allergic disease. Max. total daily dose should not exceed 150mg. P 75mg IM once or twice daily by deep Congestive cardiac failure. Platelet aggregation is Q 1-3mg/kg body weight daily in divided intragluteal inj. for 2-3 days. Continue if necessary decreased and bleeding time is prolonged. doses. Not applicable for gout. with tabs. or suppos. Pregnancy, lactation. 2MO Q Not applicable. C Anticoagulants, hydantoins, D Active peptic ulcer. Asthma, aspirin/anti- ALSO DIFENE SUPPOSITORIES Diclofenac Na+ sulphonamides, lithium, b-blockers, methotrexate, A 100mg. 10, 2.30. inflammatory induced allergy. Last trimester of probenecid, frusemide. P 1 at night. pregnancy. Severe hepatic, renal, cardiac failure. A GI intolerance (nausea, vomiting, Q Not applicable. B History of GI lesions. Renal or hepatic epigastic distress), Hypersensitivity/skin reactions 2MO dysfunction. Pregnancy, lactation. Crohn’s, UC, (rash, urticaria, anaphylaxis, angio-oedema). ALSO DIFENE 100MG DUAL RELEASE Diclofenac proctitis. May impair female fertility; not Headache, tinnitus, vertigo, blood dyscrasias. recommended in women attempting to conceive. 100mg (25mg rapid release and 75mg sust.-release pellets). Blue/transparent cap. marked D100M. 28, Tabs contain lactose. NAPROSYN EC Roche A11.93. C Lithium, digoxin, anticoagulants, 2MO antidiabetic agents, cyclosporin, methotrexate, S Musculosketal disorders, quinolone antimicrobials, other NSAIDs, Propionic acid. Naproxen 250mg, 500mg. White dysmenorrhoea, dental and minor surgery. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
155
5.4 MUSCLE
RHEUMATOLOGY
SPASM
ent-ctd tab. marked NAPROSYN EC one side, SYNTEX 250 on reverse and oblong white ent-ctd tab. marked NAPROSYN EC and SYNTEX. 250mg56, A5.20; 500mg-56, A10.41. 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.
anti-inflammatory agent for 1 month. Ensure adequate fluid intake. C Anticoagulants, chlorpropamide, mercaptopurine, azathioprine, vidarabine, salicylates and uricosuric agents, didansine, ciclosporin, ampicillin/amoxicillin, theopylline. A Skin reactions (withdraw if occur). Nausea, acute gout.
dizziness, rash, elevation of liver enzymes.
ZYLORIC
Aspen
2MO
Xanthine oxidase inhibitor. Allopurinol 100mg, 300mg. White, biconvex, scored tabs. coded GXCM2 or GXCM7 resp. 100mg-100, A8.07; 300mg-28, A6.27. S Gout, prophylaxis of uric acid and TIPURIC Clonmel calcium oxalate stones. 2MO P Initially 100mg daily. Maintenance: Mild 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 ORUVAIL sanofi-aventis maintenance 200-600mg daily. Doses in excess of B Pregnancy. Elderly. Renal or hepatic 2MO 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. Propionic acid. Ketoprofen 200mg. White/pink month. Ensure adequate fluid intake. D Acute gout. controlled-release caps. marked with Oruvail 200. C Anticoagulants, chlorpropamide, B Pregnancy. Elderly. Renal or hepatic 200mg-28, A19.61. mercaptopurine, azathioprine. dysfunction. When initiating therapy also give S Gout. A Skin reactions (withdraw if occur). colchicine or an anti-inflammatory agent for 1 P 100-200mg once daily with food. Nausea. month. Ensure adequate fluid intake. Q Not recommended. D Hypersensitivity to NSAIDs. Severe renal C Anticoagulants, chlorpropamide, 5.4 MUSCLE SPASM or hepatic dysfunction. Active or history of peptic mercaptopurine, azathioprine. A Skin reactions (withdraw if occur). ulcer haemorrage or GI bleeding/perforation ANXICALM Clonmel related to NSAID therapy. Severe heart failure. 3rd Nausea. 2NO trimester of pregnancy. VOLTAROL Novartis Long-acting benzodiazepine. Diazepam 2mg, 5mg, B Hypertension. Heart failure. Arterial 10mg. White scored tab. marked D2, yellow scored thrombotic events. Cardiovascular disease. 2MO tab. marked D5, and blue scored tab. marked D10. Oedema. GI toxicity. Visual disturbances. Phenylacetic acid. Diclofenac Na+ 25mg, 50mg. 2mg-90, A1.01; 5mg-90, A1.54; 10mg-90, A3.81. Impairment of female fertility. Serious skin Yellow ent-ctd tab. and brown ent-ctd tab. Both S Muscle spasm. Cerebral palsy, spasticity. reactions. Patients with intracranial haemorrhage marked with tab. name and strength one side, P Muscle spasm: 2-15mg daily in divided and bleeding diathesis. Asthma. Elderly. Driving/ GEIGY on reverse. 25mg-84, A8.64; 25mg-100, A5.38; 50mg-50, A6.49. doses. Management of cerebral spasticity: 2-60mg operating machinery. daily in divided doses. C Not recommended: Anticoagulants, anti- S Acute gout. platelet agents, other NSAIDs, SSRIs, lithium, P 75-150mg daily in two or three divided Q Control of tension and irritability in cerebral spasticity in selected cases: 2-40mg daily methotrexate. Diuretics, pentoxifylline, doses taken with liquid. in divided doses. Muscle spasm: as for adults. corticosteroids, b-blockers, ACE inhibitors and Q Not applicable. D See SPC. angiotensin II antagonists, amino and cardiac 2MO C Compounds which can inhibit certain glycosides, cyclosporin, probenecid, thrombolytics, ALSO VOLTAROL RETARD Diclofenac Na+ 75mg, hepatic enzymes. sulphonylureas. 100mg. Pink triangular sust.-release tab. marked A GI intolerance, hypersensitivity reactions, CG one side, ID on reverse and red sust.-release BACLOPAR Gerard haematology disorders, headache, weight gain, tab. marked VOLTAROL R one side GEIGY on taste perversion, tinnitus, dizziness, paresthesia, reverse. 75mg-30, A11.29; 100mg-28, A14.46; 2MO convulsions, somnolence, mood disorders, oedema. 100mg-30, A15.48. GABA deriv. Baclofen 10mg. White scored tab. P 1 x 75mg once daily or 1 x 75mg twice marked BN/10 one side and G on reverse. 100, daily, alternatively 1 x 100mg once daily. Both A8.89. PURINOL Pinewood strengths taken whole at mealtime. S Relief of voluntary muscle spasticity in Q Not applicable. 2MO multiple sclerosis, spinal cord lesions and motor 2MO Xanthine oxidase inhibitor. Allopurinol 100mg, neurone disease. Spasticity of cerebral origin incl. 300mg. White biconvex tabs. Engraved 1K1or 2K1 ALSO VOLTAROL SUPPOSITORIES Diclofenac Na+ meningitis, cerebral palsy, traumatic head injury, A 100mg. 10, 2.31. one side. 100 mg: Breakline on reverse. 100mgcerebrovascular accident. P 1 at night. 100, A8.07; 500, A58.20; 300mg-100, A22.39. P Initially 5mg three times daily for 3 Q Not applicable. S Urate/Uric acid deposition. Management days, increasing as required by 5mg three times 2NO of 2,8- DHA renal stones related to deficiency daily at 3 day intervals. Max. 100mg daily. ALSO VOLTAROL INJECTION Diclofenac Na+ activity of adenine phoshoribosyltransferase. Q Under 12 months, not recommended; 1++ 75mg/3ml. Amp. 10 x 3ml, A5.61. Management of recurrent mixed Ca oxalate 10 years, 0.75-2mg/kg body weight daily; over 10 renal stones in presence of hyperuricosuria, when P 75mg IM once or twice daily by deep years, max. 2.5mg/kg daily. Maintenance: 1-2 intragluteal inj. for 2 or 3 days. Continue if fluid, dietary and similar measures have failed. years, 10-20mg daily; 2-6 years, 20-30mg daily; 6necessary with tabs. or suppos. P Initially 100-300mg daily as a single 10 years, 30-60mg daily. The daily dose should be dose, increasing to maintenance, 200-600mg daily. Q Not applicable. given in at least 4 divided doses. D Active or suspected peptic ulcer. R Use lowest dosage which produces D Pulmonary insufficiency. Asthma, aspirin/anti-inflammatory induced allergy. B Psychotic disorders, schizophrenia, satisfactory urate reduction. B Renal, cardiac or hepatic dysfunction. Q Rarely indicated, except in malignant confused states, epilepsy, history of convulsions. Elderly. Pregnancy, lactation. Recent proctitis. conditions (especially Leukaemia) and certain Cerebrovascular disease, peptic ulcer, renal or enzyme disorders such as Lesch- Nyhan Syndrome. C Lithium, digoxin, anticoagulants, hepatic impairment. Urinary sphincter hypertonia. antidiabetic agents, cyclosporin, methotrexate, D Acute gout. Lactation Pregnancy. Withdraw drug gradually. Monitor quinolone antimicrobials, other NSAIDs, B Pregnancy. Elderly. Renal or hepatic blood sugar and liver function. Ability to drive or dysfunction. Asymptomatic hyperuricaemia. When corticosteroids, diuretics. operate machinery may be impaired. A Epigastric pain, nausea, headache, initiating therapy always give colchicine or an C Other CNS acting drugs, alcohol,
156
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
MUSCLE
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. BOTOX Allergan D Pregnancy, generalised muscle disorders. See SPC. 2N B Should only be used by specialists. See Bacterial toxin. Clostridium botulinum type A SPC. neurotoxin complex 100 units. Powder in vial for sln for inj. 1, A205.69. LIORESAL Novartis S Blepharospasm, hemifacial spasm, 2MO associated focal dystonias, spasmodic torticollis. Focal spasticity: a) associated with dynamic GABA deriv. Baclofen 10mg. White tab.scored and equinus foot deformity due to spasticity in marked KJ one side, C-G on reverse. 100, A8.90. paediatric cerebral palsy patients r2 years; b) of 2M wrist and hand in adult post stroke patients. ALSO LIORESAL ORAL SOLN. Baclofen 5mg/5ml. Persistent severe primary hyperhidrosis of the Sugar-free. 300ml, A7.21. axillae resistant to topical treatment. S Voluntary muscle spasticity due to P 0.05-0.1ml (blepharospasm, hemifacial cerebrovascular accidents, cerebral palsy, spasm) or 0.1-0.5ml (cervical dystonia, cerebral meningitis, multiple sclerosis, spinal lesions. palsy) inj. in muscle site. 0.1-0.2&nbsp per Treatment should not be started until spastic state intradermal inj. in primary axillary hyperhidrosis. has become stabilised. See SPC. P Initially 5mg three times daily, Q Cerebral palsy: Hemiplegia, initially 4 increasing as required by 5mg three times daily at units/kg body weight in the affected limb. 3 day intervals. Max. 100mg daily. Diplegia, initially 6 units/kg body weight divided Q 0.75-2mg/kg body weight. Initially: between the affected limbs. Total dose 200 units 2.5mg four times daily, increased at 3 day intervals max. to maintenance dose. Maintenance: 12 months-2 D Lactation, pregnancy (unless essential). years, 10-20mg daily; 2-10 years, 30-60mg daily. Infection at inj. sites. The daily dosage should be given in at least 4 B History of dysphagia and aspiration, divided doses. neurological disorders including swallowing D Respiratory impairment. difficulties, peripheral motor neuropathic diseases, B Psychotic disorders, schizophrenia, neuromuscular disorders. Angle closure glaucoma confusional states. Epilepsy, peptic ulcer disease, (blepharospasm). cerebrovascular disease, hepatic or renal C Aminoglycoside antibiotics, impairment. Urinary spincter hypertonia. spectinomycin, or other drugs interfering with Pregnancy. Withdraw drug gradually. Monitor neuromuscular transmission. blood sugar and liver function. A Dysphagia, muscle weakness, pain. C Lithium, tricyclic antidepressants, Blepharospasm: Eyelid ptosis, other eye disorders. anithypertensives, levodopa, carbidopa, fentanyl, Cervical dystonia: URI, dizziness, hypertonia, ibuprofen. hypoaesthesia, somnolence, headache. Cerebral A Sedation, drowsiness, nausea. palsy: Viral infection, ear infection, somnolence, Neurological and/or psychiatric manifestations. paraesthesia, urinary incontinence, rash, gait Hypotension. Dysuria, frequency or enuresis. disturbance. Muscle fatigue. Epileptic attacks, visual disturbances, skin rash. fentanyl, TCADs, antihypertensives, levodopa, ibuprofen. A Sedation, drowsiness, nausea. Neurological and/or psychiatric manifestations. Hypotension, dysuria, frequency of micturition, enuresis. Paradoxical increased spasticity.
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.
SPASM
5.4
White, circular sug-ctd tab. marked QD and C on one side. 28, A8.41. S Treatment and prevention of nocturnal leg cramps in adults (indication contraindicated in pregnancy). P 300mg at bedtime. May take up to 4 weeks to be effective. Closely monitor patients in the early stages of treatment. Reassess treatment at 3 months intervals. D Red blood cell enzyme deficiencies, Hburia, optic neuritis, tinnitus, fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. B Caution: Atrial fibrillation or other serious heart disease, myasthenia gravis, glucose-6phospate dehydrogenase deficiency, inadequately control malarial infection. Driving, operating machinery. Pregnancy, lactation. C Amiodarone, flecainide, quinidine, anticoagulants, terfenadine, other anti-malarial (chloroquine, artemether with lumefantrine, mefloquine), pimozide or thioridazine, cardiac glycosides, cimetidine. A Blood disorders, hypersensitivity reactions, acute renal failure, hypoglycaemia, cardiovascular effects, cinchonism (tinnitus, headache, nausea, abdominal pain, flushing, rash, visual disturbance, confusion), muscle weakness, deafness, vomiting, pruritis, excitement.
TIZAFLEX
Actavis
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. NEUROBLOC Eisai Pregnancy (unless benefit outweighs risk), lactation. 2N B Hypotension may occur. Withdraw Botulinum toxin. Botulinum toxin type B 5000 U/ ml. sln for injection. 2500 U-0.5ml, A152.55; 5000 gradually. Caution: Renal impairment, cardiovascular disorders, coronary artery disease or U-1ml, A203.40; 10000 U-2ml, A271.19. renal or hepatic disorders. Monitor liver function S Cervical dystonia (toricollis). P Initially 10000 U IM divided between 2-4 before and during treatment. Contains lactose. C Contra: Strong CYP1A2 inhibitors most affected muscles. (fluvoxamine, ciprofloxacin). Not recommended: R See lit. CYP1A2 inhibitors e.g. some antiarrhythmics Q Not recommended. (amiodarone, mexiletine, propafenone), D Other neuromuscular disease or cimetidine, some fluoroquinolones (enoxacin, neuromuscular junctional disorders. Pregnancy, pefloxacin, norfloxacin), rofecoxib, oral lactation. contraceptives, ticlopidine. Caution: Substances B Bleeding disorders or anticoagulant increasing QT interval, antihypertensives, alcohol. therapy. Do not inject into a blood vessel. A Bradycardia, tachycardia, drowsiness, C Co-administration of NeuroBloc and fatigue, dizziness, GI disorders, BP reduction, aminoglycosides or agents interfering with rebound hypertension. neuromuscular transmission should be considered with caution. TIZANIDINE (INN) Niche A Dry mouth, dysphagia, worsening torticollis, myasthenia. 2NO Central a2-agonist. Tizanidine 2mg, 4mg. White, QUININE SULPHATE Actavis round tab. marked resp. N62 or N63 on one side. 2MO 4mg scored on other side. 2mg-120 A63.33; 4mg120, A73.95. Blood schizontocide. Quinine sulphate 300mg.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
157
5.5 TOPICAL
AND INTRA-ARTICULAR ANALGESIA
RHEUMATOLOGY
ALSO DICLAC RELIEF Diclofenac (Na+) 1% w/w. Gel. 30g, A3.30. S Pain and inflammation in trauma of the Benzodiazepine. Diazepam 5mg. Scored yellow tendons, ligaments, muscles and joints e.g. due to tab.and marked with 5 and ROCHE. 5mg-100, sprains, strains and bruises. Localised forms of soft A1.80. tissue rheumatism. S Muscle spasm, epilepsy. P Massage 2-4g (3-4 times daily). P Elderly, 1-30mg daily; others, 2-60mg Q Under 12 years, not recommended. daily. Both in divided doses. See SPC. D Aspirin/anti-inflammatory induced Q 2-40mg daily in divided doses. allergies. Patients in whom attacks of asthma, D See SPC. urticaria or acute rhinitis are precipitated by NSAIDs. Pregnancy, lactation (no experience). ZANAFLEX Cephalon B Avoid broken skin, occlusive dressings, eyes and mucous membranes. History of, or active 2NO peptic ulceration. Can precipitate bronchoplasm in Central a2-agonist. Tizanidine (HCl) 2mg, 4mg. patients with bronchial asthma. White tabs. cross-scored marked with logo and C Other drugs containing diclofenac coded 592 or 594. 2mg-120 A70.94; 4mg-120 (avoid). Caution: Oral NSAIDs. A88.68. A Itching, mild local reactions, rash, S Spasticity associated with multiple isolated photosensitivity reactions. sclerosis, spinal cord injury or disease. P Initially 2mg increasing in 2mg Astellas increments at not less than 3-4 day intervals. Give DIFENE SPRAY GEL in divided doses 3 or 4 times daily. Titrate 2MO according to response, usually up to 24mg daily; Topical NSAID. Diclofenac Na+ 40mg/1g soln. (4%). max. 36mg daily in divided doses. Golden-yellow transparent soln. 30ml, A8.06. Q Not recommended. S Local symptomatic relief of mild to D Hepatic impairment. moderate pain and inflammation following acute B Renal impairment. Pregnancy, lactation. blunt trauma of small and medium-sized joints Exclude liver disease. and periarticular structures. C Diuretics, b-blockers, antihypertensives, P 4-5 sprays 3 times daily. digoxin, oral contraceptives, alcohol. Q Under 15 years, not recommended. A Drowsiness, fatigue, dizziness, dry 2MO mouth, GI upset, hypotension, insomnia, ALSO DIFENE GEL Diclofenac Na+ 1%. Gel. 50g, bradycardia, hallucinations. A2.78. S Local symptomatic relief of pain and 5.5 TOPICAL AND INTRA-ARTICULAR inflammation in joints, tendons, muscles, ligaments ANALGESIA and soft tissue injury. P 2-4g (2-2.5 cm) applied 2-4 times daily. AULIN GEL Helsinn Birex Q Not recommended. 2MO D Aspirin/anti-inflammatory induced allergy. Last trimester of pregnancy. Lactation. Selective COX-2 inhibitor. Nimesulide 3%. Gel. B Should only be admin. to intact skin. 50g, A2.46. 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 hepatic dysfunction, severe coagulation disorders 2O 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. 2MO D Pregnancy, lactation (unless essential). Topical analgesic. Capsaicin 0.075%. Cream. 45g, B Donâ&#x20AC;&#x2122;t apply to eyes or mucosal surfaces. A16.22. Risk of allergic reactions to some excipients. S Post-herpetic neuralgia and painful diabetic neuropathy. DUROLANE Smith & Nephew P Apply sparingly 3-4 times daily. Hyaluronan. Non-animal, stabilised, hyaluronic Q Not recommended. acid 60mg. Sterile, transparent viscoelastic gel D Broken or irritated skin. supplied in a 3ml glass syringe. 20mg/ml-1, A307. B Keep away from eyes. S Symptomatic treatment of mild to A Transient burning on application. moderate knee or hip osteoarthritis. Before or after applying Axsain, avoid hot bath or P 3ml intra-articularly per knee or hip shower. joint. DICLAC GEL 1% Rowex B Not recommended: Infected or severely inflamed knee or hip joint, presence of active skin 2MO disease or infection at or near the injection site. NSAID. Diclofenac (Na+) 1% w/w. Gel. 50g, A2.78. Should not be injected intravascularly or extra2K articularly or in the synovial tissues or capsule.
VALIUM
Roche
2NO
158
Caution: Venous or lymphatic stasis in the leg. Use a separate syringe or each knee or hip. Small risk of infection. Pregnancy, lactation. A Mild and transient arthralgia.
ETOFLAM
Phoenix
2MO Flufenamic acid derivative. Etofenamate 5%. A nearly transparent yellowish gel. 100g, A8.46. S Inflammatory disorders of the musculoskeletal system. P Topical use only. Apply a 5-10cm strip of gel (according to the area affected) and rub gently. Q Not recommended. D Hypersensitivity to NSAIDs including aspirin. Use with: Occlusive dressings; any other topical preparation on the same site. Local infection, broken skin. Pregnancy, lactation. B Contains alcohol (avoid contact with eyes/mucous membranes). Wash hands after use. Do not apply to irritated/broken skin. If irritation develops discontinue. Consult doctor if no improvement/aggravation develops.
EUFLEXXA
Ferring
O Hyaluronan. Hyaluronic acid (Na+ salt) 10mg/ml. Soln in prefilled syringe. 1, A155.61. S Pain caused by osteoarthritis of the knee. P 2ml injected into the affected knee 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
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
TOPICAL
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 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.
MESULID GEL
Ergha
2MO Selective COX-2 inhibitor. Nimesulide 3%. Gel. 50g, A2.39. S Symptomatic relief of pain associated with sprains and acute traumatic tendinitis. P 3g (6-7 cm) rubbed into affected area two or three times daily. Duration 7-15 days. Q Under 12 years, contraindicated. D Aspirin/anti-inflammatory induced allergy. Pregnancy, lactation (unless clearly necessary). Use on skin wounds or infections. B Avoid contact with eyes, mucous membranes. GI bleeding, peptic ulcer, severe renal or hepatic dysfunction, severe coagulation disorders or severe/non controlled HF. Exposure to direct and solarium sunlight. A Itching, erythema.
NUROFEN GEL
Reckitt Benckiser
2 NSAID. Ibuprofen 5% WW gel. Gel. 30g, A4.29. S Pain and inflammation in the trauma of the tendons, ligaments, muscles and joints and in localised forms of soft tissue rheumatism. P Apply to affected area and massage in up to 3 times a day. Review treatment after 2 weeks. Q Under 14 years, not recommended except under medical advice. D Aspirin/anti-inflammatory induced allergies. B Avoid eyes, mucous membranes, inflamed or broken skin, occlusive dressings.
AND INTRA-ARTICULAR ANALGESIA
5.5
Discontinue if rash develops. Pregnancy, lactation. C Aspirin or other NSAIDs. A Application site reactions, rashes, pruritis, urticaria, abdominal pain, dyspepsia.
B Should only be injected by healthcare professionals trained in the procedure. Must not be injected into blood vessels. Do not inject if inj. site is inflamed, infected or if evidence of acute or 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. Q Under 12 years, contraindicated. S As replacement for synovial fluid 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, SYNVISC Genzyme intracranial haemorrhage or bleeding diathesis. 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 inj. Max. recommended dosage, 6 inj. within 6 2 months, with 4 weeks minimum between NSAID. Ketoprofen 2.5%. 30g, A4.20; 10 x 30g, treatment regimens. Osteoarthritis of the hip / A39.00. S Backache, muscular and rheumatic pain, ankle / shoulder. Initially, single inj. If adequate symptomatic relief not achieved, 2nd inj. sprains, strains and sports injuries. P Apply thin layer of gel to affected area recommended (between 1 and 3 months after 1st inj.). 3 times daily for up to 7 days. Q Not recommended. Q Under 12 yrs, contraindicated. ALSO SYNVISC-ONE Hylan G-F 20, 6ml. 1 syringe, D Hypersensitivity reactions to NSAIDs. A264. Eczema, acne, infectious skin or open wounds. S Temporary replacement and supplement Active peptic ulceration. Use with occlusive for synovial fluid. dressings. Simultaneous use to same site with P Osteoarthritis of the knee. One inj. in other topical cream. 3rd trimester of pregnancy, the knee. May be repeated 6 months after. lactation. Q Not recommended. B Renal, cardiac or hepatic impairment. D Venous or lymphatic stasis. Infected or Rash. Pregnancy. Avoid broken skin, eyes and severely inflamed joints, skin diseases or infections mucous membranes. Direct sunlight or solarium should be avoided. Elderly. History of peptic ulcer in the area of the injection site. Hypersensitivity to avian proteins. or IBD, intracranial haemorrhage or bleeding B Do not inject IV, extra-articularly or into diathesis. A Mild local irritation. Erythema, pruritus, synovial tissues and capsule. Do not use in case of large intra-articular effusion prior to injection. photosensitivity reactions. Pregnancy. PHORPAIN Goldshield C Avoid disinfectants containing quaternary ammonium salts for skin preparation. 2O A Transient pain and/or, swelling and/or NSAID. Ibuprofen 5%. Gel. 100g, A3.77. effusion in the injected joint. S Systemic relief of backache, rheumatic and muscular pain, sprains, strains and neuralgia. TRANSVASIN Thornton & Ross P Massage in up to 3 times dailly. Review 2K therapy after 2 weeks. Rubefacient. Tetrahydrofurfuryl salicylate 14%, Q Not recommended. ethyl nicotinate 2%, hexyl nicotinate 2%. Cream. D Aspirnin/anti-inflammatory induced 40g, A1.64. allergies. History of asthma. Pregnancy, lactation. S Rheumatic and muscular pain, strains B Avoid broken skin, occlusive dressings, and sprains. eyes and mucous membranes. V Massage in gently at least twice daily. A Mild local irritation, rash. B Broken or sensitive skin, mucous SPORTVIS Movianto membranes. A Localised sensitisation reactions. Hyaluronan Hyaluronic acid (Na+ salt), 1%. Clear sln in prefilled syringe. 2, A139.50. TRAXAM GEL Goldshield S To relieve pain and optimise recovery of the ankle following first or second degree sprain. 2 M O NSAID. Felbinac 3%. Gel. 7.5g, A1.78; 100g, P 1 peri-articular inj. within 48 hours of A10.21. ankle sprain injury followed by a 2nd inj. 2-3 days st 2MO after the 1 inj.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
159
5.6 MYASTHENIA
RHEUMATOLOGY
GRAVIS
Q Under 18 years, not recommended. D Co-admin. with nitrates, cardiac disease when sexual activity is inadvisable, MI within 90 days, unstable angina or angina occurring during 6.1 HYPOGONADISM, ERECTILE sexual intercourse, HF, uncontrolled arrhythmias, hypotension, uncontrolled hypertension, stroke DYSFUNCTION, OTHER SEXUAL within 6 months, loss of vision in one eye caused DISORDERS by non-arteritic anterior ischaemic optic ANDROCUR 100 Bayer Schering neuropathy (NAION). B Medical history/physical examination 2NO should be undertaken to diagnose erectile Anti-androgen. Cyproterone (acetate) 100mg. Off- dysfunction. Consider cardiovascular status of white cap.-shaped scored tab. marked LA each patient prior to treatment. Serious cardiovascular side of score, hexagon on reverse. 60, A82.14. events reported. May induce a BP decrease. Visual S Severe hypersexuality and sexual VOLTAROL EMULGEL defects and cases of NAION may occur. Severe deviation in the male. Prostatic carcinoma. Hot hepatic impairment. Renal insufficiency (not Novartis Consumer flushes. recommended). Conditions which predispose 2M P Severe hypersexuality and sexual patients to priapism (sickle cell anaemia, multiple Diclofenac diethylammonium equiv. diclofenac Na+ deviation in males: usually 50mg morning and myeloma, leukaemia). Continuous daily use not 1% w/w. Gel. 30g, A4.38. evening. Hot flushes: 100mg daily, increase to recommended. Contains lactose. S Trauma of the tendons, ligaments, 200mg if necessary. Prostatic carcinoma, C Not recommended: a-blockers, other ED muscles and joints, eg. due to sprains, strains and monotherapy: 100mg twice or three times daily. treatments. CYP3A4 inhibitors, CYP3A4 inducers. bruises; soft tissue rheumatism. Reduction of LHRH agonist tumour flare: initially A Headache, dizziness, palpitations, P 2-4g gel rubbed gently into affected 100mg twice daily alone for 5-7 days, followed by flushing, nasal congestion, GI disorders, back pain, area 3 or 4 times daily. Max. duration 7 days. 100mg twice daily for 3-4 weeks, with LHRH myalgia. Q Not recommended. agonist in dosage recommended by manufacturer. 2MO Elimination of effect of adrenocortical androgens DECAPEPTYL 3 MONTHS Ipsen with LHRH agonist/orchiectomy: 100mg once or ALSO VOLTAROL EMULGEL Diclofenac 6NT twice daily. diethylammonium equiv. diclofenac Na+ 1% w/w. Gn-RH analogue. Triptorelin 11.25mg. Powder in Q Not applicable. Gel. 50g, A2.79. vial plus 2ml diluent. 1, A431.71. D Acute liver disease. Malignant/wasting S Trauma of the tendons, ligaments, S Precocious puberty (onset before 8 years diseases (other than prostatic carcinoma); severe muscles and joints, eg. due to sprains, strains and in girls and 9 years in boys). chronic depression; history of thrombosis/ bruises; soft tissue rheumatism. Osteoarthritis of embolism. Age Q 18 or incomplete bone/testicular P 1 vial (11.25mg) as single IM inj. at 3 superficial joints such as the knee. month intervals. See SPC. development. P 2-4g gel rubbed gently into affected Q Not applicable. B See SPC. area 3 or 4 times daily (max. 6 weeks). Review D Pregnancy. C See SPC. treatment after 14 days, in OA review after 4 A Site reactions, arthralgia. Mild or A See SPC. weeks. moderate withdrawal bleeding in girls (1st Q Not recommended. CAVERJECT Pharmacia month). D Aspirin/anti-inflammatory induced allergy. 2NO GONAL-F Merck Serono B Use only on intact skin. Avoid occlusive Prostaglandin. Alprostadil 5mcg, 10mcg, 20mcg. 2N dressings, eyes and mucosa. Pregnancy, lactation Powder and solvent for soln. 5mcg-1, A6.89; (not recommended). Gonadotrophin. Follitropin alfa 75 IU (5.5mcg)/ml, 10mcg-1, A8.25; 20mcg-1, A10.74. A Itching, skin rash. Rarely photosensitivity S Treatment and diagnosis of erectile 300 IU (22mcg)/0.5ml; 450 IU (33mcg)/0.75ml, 900 reactions. IU (66mcg)/1.5ml, 1050 IU (77mcg)/1.75ml. Single/ dysfunction. P Initially 2.5mcg by intracavernous inj. If multidose vials or pre-filled pen. Single dose: 75 ZACIN Cephalon necessary increase in 2.5mcg increments to max. IU-1, A38.20; 5, A192.67. Multidose: 450 IU-1, A231.20; 1050 IU-1, A539.48. Pre-filled pen: 300 2MO 60mcg. Max. once daily and 3 times per week. IU-1, A162.55; 450 IU-1, A243.83; 900 IU-1, Q Not applicable. Topical analgesic. Capsaicin 0.025%. Cream. 45g, A487.66. A16.22. D Sickle cell anaemia, multiple myeloma, leukaemia. Penile angulation or fibrosis. Petronieâ&#x20AC;&#x2122;s S Stimulation of spermatogenesis in men S Symptomatic relief of pain associated with congenital or acquired hypogonadotrophic disease. with osteoarthritis. hypogonadism in combination with human B Advise patients to seek medical P Apply sparingly 4 times daily. Chorionic Gonadotrophin (hCG). attention if erection persists q 4 hours. Q Not recommended. P 150 IU three times a week, C Warfarin, heparin. D Broken or irritated skin. concomitantly with hCG, for minimum 4 months. A Penile pain, priapism, fibrosis, B Keep away from eyes. Before or after 18 months may be necessary. angulation, inj. site reactions, headache, applying Zacin, avoid hot bath or shower. D Pituitary or hypothalamus tumours. hypertension, dizziness. A Transient burning on application. Primary testicular insufficiency. 5.6 MYASTHENIA GRAVIS CIALIS Lilly B Semen analysis recommended 4 to 6 months after beginning of treatment. 2NO MESTINON Meda A Gynaecomastia, acne, weight gain. Phosphodiesterase type 5 inhibitor. Tadalafil
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.
C Depolarising muscle relaxants, cyclopropane, halothane. A Nausea, salivation, diarrhoea, colic.
2MO
10mg, 20mg. Film-ctd almond-shaped tabs. light yellow marked C10 and yellow marked C20, resp. 10mg-4, A25.79; 20mg-4, A25.79. S Treatment of erectile dysfunction. In order to be effective, sexual stimulation is required. Not indicated for use by women. P Males:10mg taken at least 30 min before sexual activity. The dose may be increased to 20mg if 10mg does not produce adequate effect. Efficacy may last for up to 36 hrs post-dose. Severe renal impairment, 10mg max. Continuous daily use not recommended.
Anticholinesterase. Pyridostigmine bromide 60mg. White quarter-scored tab. marked ICN. 200, A53.85. S Myasthenia gravis. P Usually 5-20 tabs. daily in divided doses. Q Neonates, 5-10mg four hourly. Under 6 years, initially 30mg; 6-12 years, initially 60mg increasing by 15-30mg daily until control. D Intestinal or urinary obstruction. B Bronchial asthma, cardiac disease, vagotonia, epilepsy, Parkinsonism.
160
GONAPEPTYL DEPOT
Ferring
6NT Gn-RH analogue. Triptorelin (acetate) 3.75mg. Powder and solvent for inj. prolonged release in pre-filled syringe. 1, A183.98. S Precocious puberty (girls under 9 years, boys under 10 years). Q One inj. on days 0, 14, and 28 by SC or deep IM inj. Thereafter one every 28 days; if effect insufficient, inj. may be given every 21 days. Dose should be based on body weight: Q20kg, half
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
HYPOGONADISM, ERECTILE
DYSFUNCTION, OTHER SEXUAL DISORDERS
dose; between 20-30kg, (2/3 dose); q30kg, full dose. D Progressive brain tumours. B Preclude pseudo-precocious puberty and gonadotropin-independent precocious puberty. Allergic and anaphylactic reactions reported. C Oestrogen. A Bone pain, libido decreased, hot flushes, dysuria, impotence, mood changes, headache, vaginal disorders, perspiration. Hypersensitivity, depressive mood, irritability, nausea, myalgia, arthralgia, tiredness, sleep disorders, inj. site pain/ reaction, gynecomastia.
decreased to 5mg. Max. dose 20mg; max. frequency, once daily. Mild and moderate hepatic impairment/severe renal impairment: Consider 5mg initially; moderate hepatic impairment: Max. 10mg. R Initially 5mg. Q Under 18 years, not recommended. D Cardiac disease for whom sexual activity 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 LEVITRA Bayer Schering ED. Anatomical deformation of penis, conditions 2NO which predispose to priapism (sickle cell anaemia, Phosphodiesterase type 5 inhibitor. Vardenafil multiple myeloma, leukaemia). Bleeding disorders, 5mg, 10mg, 20mg. Orange film-ctd tabs. marked active peptic ulcer. Sudden visual defect, with BAYER cross one side and 5, 10 or 20 on discontinue and consult physician immediately. reverse. 5mg-4, A20.93; 10mg-4, A24.40; 20mg-4, C Nitrates or nitric oxide donors, A29.64. ketoconazole and itraconazole (men q75 years), S Erectile dysfunction. protease inhibitors. Avoid potent CYP3A4 P 10mg taken approx. 25-60 mins. before inhibitors, grapefruit juice, antiarrhythmic sexual activity. May be increased to 20mg or 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
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
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 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
161
6.1 HYPOGONADISM,
ERECTILE DYSFUNCTION, OTHER SEXUAL DISORDERS
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.
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 PUREGON Schering-Plough periodically. May accelerate progression of sub2NO clinical prostate cancer and BPH. Irritability, Gonadotropin. Recombinant FSH 50 IU, 100 IU, nervousness, weight gain, prolonged or frequent 150 IU, 300 IU, 600 IU, 900 IU FSH activity. Soln for erections may indicate excessive androgen exposure requiring dosage adjustment. Contains inj. in vials 0.5ml (50 IU-150 IU), or cartridges propylene glycol. 0.36ml (300 IU), 0.72ml (600 IU), 1.08ml (900 IU). C Caution: Anti-coagulants, ACTH, 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 corticosteroids, propranolol. A Worsened hypertension, headache, IU-1, A477.90. acne, appl. site reaction (incl. erythema, rash, S Deficient spermatogenesis due to pruritus). Increased: PSA, haematocrit, Hb, red hypogonadotrophic hypogonadism. P 450 IU/week, preferably in 3 dosages of blood cell count. 150 IU, concomitantly with hCG, for at least 3 to 4 TESTOGEL Bayer Schering months. 18 months or longer may be necessary. All by SC inj. (cartridges and vials) or SM inj. 5NO (vials). Androgen. Testosterone 50mg/5g. Gel. 30 x 5g, A41.17. Q Not applicable. D Tumours of pituitary, hypothalamus, S Testosterone replacement therapy for testis. Primary testicular failure. male hypogonadism. B Exclude uncontrolled non-gonadal P 5g applied once daily. endocrinopathies. Analyse semen 4 to 6 months Q Under 18 years, not recommended. after beginning of treatment. D Prostatic or breast carcinoma. Use in A Inj. site reactions. women. B Examine prostate and breast at least RESTANDOL TESTOCAPS Schering- annually, or twice yearly in elderly/at risk patients. Plough Not a treatment for male sterility or impotence. Cancer patients at risk of hypercalcaemia. Severe 5NO cardiac, hepatic or renal insufficiency; ischaemic Androgen. Testosterone (undecanoate) 40mg. heart disease, hypertension, epilepsy, migraine. Soft, oval, orange, transparent, glossy cap. with Perform regular tests for testosterone, Hb, yellow oily fill marked Org DV3. 60, A18.31. haematocrit and liver function. Increased risk of S Male hypogonadism and osteoporosis sleep apnoea. Improved insulin sensitivity may due to androgen deficiency. occur. P Prepubertal and adult males: Initially 3-4 C Oral anticoagulants, ACTH, daily for two to three weeks with morning and corticosteroids. evening meal, adjusting to 1-3 daily. A Reaction at application site, erythema, Q Not applicable. acne, dry skin. Changes in lab. tests, headache, D Prostatic or breast cacinoma. prostatic disorders, gynaecomastia, mastodynia, Hypercalciuria, hypercalcaemia, nephrosis. IHD, dizziness, paresthesia, amnesia, hyperaesthesia, untreated HF. mood disorders, hypertension, diarrhoea, alopecia. B Cardiac, renal or hepatic impairment. Reactions to oral or injectable testosterone include Epilepsy, migraine, hypertension. prostatic changes and progression of sub-clinical C Caution: Barbiturates and prostatic cancer, urinary obstruction, pruritus, phenylbutazone. arterial vasodilation, nausea, cholestatic jaundice, A Oedema, premature closure of changes in liver function tests, increased libido, depression, nervousness, myalgia. During high epiphyses, priapism, decreased fertility.
162
HORMONES
dose prolonged treatment, electrolyte changes, oligospermia, priapism.
TOSTRAN
Clonmel
5NO Androgen. Testosterone 20mg/g. Gel in metered dose canister. 60g, A36.30. S Testosterone replacement therapy for male hypogonadism. P Initially 3g of gel applied once daily to abdomen or both inner thighs, at the same time in the morning. Dose titration should be based on serum testosterone levels and the existence of clinical signs and symptoms of androgen deficiency. Daily range: 2-4g of gel. Q Not applicable. D Carcinoma of breast or prostate. Use in women. B Not indicated for male infertility or sexual dysfunction/impotence. Exclude risk of preexisting prostate cancer. Progression of sub-clinical prostatic cancer and benign prostatic hyperplasia may be accelerated. Caution in patients with renal or hepatic impairment, skeletal metastases (monitor Ca++), hypertension, ischaemic heart disease, epilepsy, migraine. Increased risk of sleep apnoea. Perform full blood count, lipid profile and liver function tests periodically. May cause improved insulin sensitivity. Dose adjustment may be required if symptoms of excessive androgen exposure occur. Inform patients about the risk of 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,
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 one site. Q Under 6 years, not recommended. Older children, adjust dose suitably. D Active peptic ulcer (or history). Active/ latent/healed tuberculosis; viral infection, systemic fungal infections or active bacterial infections not controlled by antibiotics. Acute psychoses. Admin. VIRIDAL DUO UCB by IV, intrathecal or intraocular inj. B Recent intestinal anastomoses, 2NO thrombophlebitis, psychotic tendencies, Prostaglandin. Alprostadil 10, 20, 40mcg. Powder exanthematous disease, chronic nephritis, plus diluent in dual chamber cartridges, needles. metastatic carcinoma, osteoporosis, acute Starter packs (with applicator): 10mcg-2, A35.24 glomerulonephritis, hypertension, CHF, glaucoma (hospital only). 20mcg-2, A42.97 (hospital only). (or history), previous steroid myopathy, epilepsy, 40mcg-2, A50.05, (hospital only). Continuation liver failure, diabetes, hypothyroidism, cirrhosis. packs (without applicator): 10mcg-2, A21.51. Menstrual irregularities may occur. Anaphylactoid 20mcg-2, A25.84. 40mcg-2, A35.28. Applicator reactions have occurred rarely. Prolonged therapy: (free of charge from Schwarz). Particularly in children; withdraw gradually. Risk S Treatment and diagnosis of erectile of increased susceptibility to infections and their dysfunction. severity. Contains benzyl alcohol. Intra-turbinal, P See SPC. subconjunctival, sub-tenons, retrobulbar and Q Not applicable. intraocular inj.; no adequate safety data. IntraD Sickle cell disease, leukaemia, multiple articular Inj.: Avoid over-use of joints in which myeloma, anatomical deformation of the penis symptomatic benefit has been obtained; if inj. is (e.g. cavernosal fibrosis, Peyronie’s disease). Penis given into tendon sheaths, avoid inj. into tendon implants. Men for whom sexual activity is itself; avoid repeated inj. into inflamed tendons. contraindicated. Do not inj. achilles tendon. Pregnancy, lactation; B Caution: Coronary heart disease, CHF, not recommended. See SPC. pulmonary disease, history of transient ischaemic C Amphotericin B inj., K+ depleting attacks, blood clotting disorders. Advise patients agents, anticholinesterases, oral anticoagulants, to seek medical attention if erection persists q4 antidiabetics, antihypertensives incl. diuretics, antihrs. Evaluate risk-benefit: Pre-existing scarring, nodules of the cavernous body, pre-existing penile tubercular drugs, cyclosporin, digitalis glycosides, oestrogens, hepatic enzyme inducers, human deviation, clinically relevant phimosis. Increased growth hormone, ketoconazole, nondepolarising risk of penile scarring if excessive use. muscle relaxants, NSAIDs, thyroid drugs, vaccines. C Not recommended: a-adrenergic blocking agents, papaverine. Caution: MAOIs with A Fluid and electrolyte disturbances, increased susceptibility and severity of infections. a-adrenergic drugs, BP lowering and vasodilating Hypersensitivity reactions. GI, musculoskeletal, skin, drugs. A Burning sensation during and after inj., eye, endocrine and neurological disorders. See sensation of tension in the penis, pain at inj. site, SPC. fibrotic alterations. grapefruit juice), alpha-blockers (not within 4 hours). Other treatments for erectile dysfunction, not recommended (no data). A Headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision. Serious cardiovascular events. Rarely priapism.
CORTICOIDS 6.2 V 5-60mg daily, see SPC. Maintenance: Reduce to min. effective dose. D Untreated systemic infections, ocular herpes simplex, Cushing’s disease. B Caution with:Tuberculosis, hypertension, CHF, liver failure, renal insufficiency, family history of diabetes, osteoporosis, history of severe affective disorders or steroid-induced psychoses, epilepsy, hypothyroidism, cirrhosis, peptic ulceration, previous steroid myopathy, thromboembolic disorders, patients with myasthenia gravis receiving anticholinesterase therapy; elderly, children. Risk of adrenocortical insufficiency. Avoid exposure to chickenpox, herpes zoster, measles. Pregnancy, lactation (only if benefit outweighs risk). C Live vaccines (wait 3 months). Caution: CYP3A4 inducers/inhibitors, antidiabetic drugs, NSAIDs, rifamycins, erythromycin, anticoagulants, amphotericin, ritonavir, cardiac glycosides, ciclosporin, methotrexate, mifepristone, oestrogens, somatropin, sympathomimetics, antihypertensives, diuretics. A See SPC.
DEPO-MEDRONE
Pharmacia
4NO
Glucocorticoid (Prohibited in Competition when given by intra-muscular route see Section 14.1). 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 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, BETNELAN UCB ulcerative colitis and Crohn’s disease. P Intra-articular: 10-80mg depending on 6.2 CORTICOIDS 0NO joint size and severity of condition. Periarticular: 4Glucocorticoid. Betamethasone 0.5mg. White 30mg. Intralesional: 20-60mg. See SPC. ADCORTYL BMS scored tab. marked with tab. name and EVANS. (Intramuscular: Allergic conditions see Section 100, A4.22. 4NO 14.1) S Severe asthma, allergic conditions, hay Glucocorticoid. Triamcinolone (acetonide) 10mg/ Q Dose depends on condition and to a fever, RA, collagen diseases. ml. Aqueous susp. 1ml and 5ml vials. 5 x 1ml, lesser extent body weight and patient age. P 0.5mg-5mg daily, reduce maintenance A5.94; 1 x 5ml, A4.81. 4NO to min. effective dose. S Intra-articular joint pain, swelling and ALSO DEPO-MEDRONE WITH LIDOCAINE PERI/ stiffness associated with rheumatoid arthritis (RA) Q Under 1 year, not recommended; 1-7 INTRA ARTICULAR Methylprednisolone (acetate) years, t-v adult dose; 7-12 years, v-x adult dose. and osteoarthrosis. Bursitis, epicondylitis, 40mg, lidocaine (HCl) 10mg/ml. Susp. for inj. in tenosynovitis. Intradermal lichen simplex chronicus, D See SPC. vials. 10 x 1ml, A29.36; 1 x 2ml, A5.33. granuloma annulare, lichen planus, keloid, S Local use in inflammatory or rheumatic BETNESOL UCB alopecia areata, hypertrophic scars. conditions. 0NO P Intra-articular: 2.5-15mg depending on P Intra articular: 10-80mg depending severity of condition and joint size. Intradermal: 2- Glucocorticoid. Betamethasone Na+ phos. 0.5mg. upon joint size and severity of condition. 3mg depending on size of lesion. Max. 5mg in Pink scored tab. marked with tab. name and Periarticular: 4-30mg. See SPC. EVANS. 100, A3.71. Q Dose depends on condition and to a S Severe asthma, allergic conditions, RA, lesser extent body weight and patient age. collagen diseases. D See SPC. Do not give via intrathecal or P 0.5mg-5mg daily in water; reduce IV routes. Do not inject into achilles tendon. maintenance to min. effective dose. B Elderly, children, diabetes, chronic Q Under 1 year, not recommended; 1-7 psychoses, CHF, renal insufficiency, glaucoma, years, t-v adult dose; 7-12 years, v-x adult dose. osteoporosis. See SPC. D See SPC. C Cyclosporin, warfarin, salicylates. Hypersensitivity, GI disorders, elevated DELTACORTRIL ENTERIC Phoenix A liver function tests, anti-inflammatory and 0NO immunosuppressive effects, musculoskeletal Glucocorticoid. Prednisolone 2.5mg, 5mg. Brown effects, fluid and electrolyte disturbances, skin and maroon ent-ctd tabs. 2.5mg-30, A2.01; 2.5mg- disorders, endocrine and metabolic disorders, 100, A5.40; 5mg-30, A3.54; 5mg-100, A9.90. neuropsychiatric disorders, ophthalmic disorders, S Conditions requiring systemic leucocytosis, thromboembolism, malaise, corticosteroid therapy. See SPC. withdrawal symptoms.
Anti-Doping Information d This medicine is permitted but should be declared on the Doping Control Form at the time of testing.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
163
6.3 GROWTH
HORMONES
FAILURE AND ACROMEGALY
posterior subcapsular cataracts, glaucoma, vertigo, convulsions, headache, psychic disturbances, thin fragile skin, impaired healing, skin reactions, Mineralocorticoid. Fludrocortisone (acetate) 0.1mg. endocrine disorders, GI disorders, muskuloskelal Pink scored tab. marked SQUIBB and coded 429. effects. 56, A3.13; 100, A10.80. S Replacement therapy in Addison’s KENALOG BMS disease. Treatment of salt losing adrenogenital 4NO syndrome. Glucocorticoid (Prohibited in Competition when P Addison’s disease: 0.05-0.3mg daily. given by intra-muscular route see Section 14.1). Adrenal hyperplasia: 1-2mg daily. Restrictions of Triamcinolone (acetonide) 40mg/ml. Pre-filled Na+ intake and K+ suppl. may be required. syringe. 1ml, A2.46; 2ml, A4.26. Q Adjust adult dose according to age, S Intra-articular: Joint inflammation such weight and severity. as seen with RA, OA, psoriatic arthropathy, bursae D Peptic ulcer, active TB, acute psychosis, and tendons. Intramuscular: Corticosteroid bacterial/viral infections. Pregnancy (only if responsive conditions incl. allergic asthma, RA, essential). certain connective tissue disorders, where depot B Adrenal cortical atrophy-develops with therapy is indicated. prolonged therapy. Withdraw gradually. Chicken P Intra-articular: 5-10mg for smaller joints; pox, shingles, measles. Diverticulitis, recent up to 40mg for larger joints depending on specific intestinal anastomoses, thrombophlebitis, severe disease being treate. (Intramuscular: Allergic affective disorders (or history of), renal conditions see Section 14.1). insufficiency, chronic nephritis, exanthematous D Systemic infections unless specific antidisease, metastatic carcinoma, osteoporosis, infective therapy is employed. Admin. by IV, myasthenia gravis, latent or healed TB, systemic intrathecal or intraocular inj. fungal infections, hypertension, CHF, glaucoma, B Risk of increased susceptibility to previous steroid myopathy, epilepsy, hypo/ infections and their severity. Recent intestinal hyperthyroidism, cirrhosis, diabetes. Menstrual anastomoses, thrombophlebitis, psychotic irregularities may occur. Anaphylactoid reactions tendencies, exanthematous disease, chronic have occured rarely. Children, elderly. nephritis, metastatic carcinoma, osteoporosis, C Amphoteracin B inj. And K+ depleting active peptic ulcer (or history); latent or healed agents. Anticholinesterases, oral anticoagulants, tuberculosis; in acute glomerulonephritis. antidiabetics, antihypertensives and diuretics, Hypertension; glaucoma (or history), previous Isoniazid, cyclosporin, Digitalis glycosides, steroid myopathy or epilepsy, diabetes, oestrogens, CYP450 inducers, ketokonazole, nonhypothyroidism, cirrhosis. Do not carry out intradepolarising muscle relaxants, NSAIDs, vaccines. articular inj. in the presence of active infection in A Electrolyte disturbance, mineral or near joints. Intra-turbinal, subconjunctival, submetabolism, glucose metabolism and tenons, retrobulbar and intraocular inj.; no gluconeogenesis, nitrogen depletion, diminished adequate safety data. Anaphylactoid reactions lymphoid tissue and immune response, inhibition reported rarely. Withdraw gradually. Contains of pituitary function, Cushingoid Syndrome, benzyl alcohol. Prolonged use; particularly in increase in blood coagulability, diminished children. Intra-articular inj.: Avoid over-use of inflammatory response. 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
FLORINEF
BMS
0NO
insufficiency, hypertension, diabetes, CHF, recent MI, previous steroid myopathy, glaucoma, osteoporosis, myasthenia gravis, cerebral malaria, hypothyroidism, cirrosis, latent amoebiasis, strongyloidiasis, ocular herpes simplex. Growth retardation. Pregnancy. Driving/using machines. C Live virus vaccines (contra). Caution: Phenytoin, ephedrine, rifabutin, carbamazepine, aminoglutethimide, barbiturates, rifampicin, ketoconazole, coumarin anticoagulants, K+depleting diuretics, acetylsalicylic acid. A Hypersensitivity, leucocytosis, thromboembolism, weight gain, increased appetite, nausea, elevation of BP, salt and water retention,
164
PREDNESOL
Phoenix
0NO Glucocorticoid. Prednisolone (disodium phos.) 5mg. Soluble pink scored tab. marked PRED SOV. 20, A6.67. S Allergic, rheumatic and inflammatory conditions. P Initially 10-100mg in water daily in divided doses reducing to min. effective dose. See SPC. Q Under 1 year, not recommended; 1-7 years, t-v adult dose; 7-12 years, v-x adult dose. D See SPC.
SOLU-CORTEF
Pharmacia
0NO Glucocorticoid-mineralocorticoid. Hydrocortisone (sodium succinate) 100mg. Rubber capped vial with white to off white powder and water for injections. 10 x 100mg without diluent, A5.24. S Conditions where rapid corticosteroid effect is required. P 100-500mg by slow IV inj. over 1-10 mins. Repeat 2 to 6 hourly as necessary. Q Dose may be reduced according to severity of condition and response but should not fall below 25mg daily. D Systemic infections. Lactation. B Withdraw therapy gradually. Salt and/or mineralocorticoid admin. concurrently. May mask signs of infections. Monitor: Use of corticosteroids in TB. Avoid IM inj. in deltoid area. Caution: Osteoporosis, hypertension, CHF, severe affective disorders, diabetes mellitus, glaucoma, cirrhosis, renal insufficiency, epilepsy, peptic ulceration. UC, diverticulitis, myasthenia gravis, hypothyroidism, Cushing’s syndrome. Children: Keep treatment to min. Elderly. C Cyclosporin, CYP450 inhibitors/inducers, anticholinesterases, hypoglycaemic agents, antihypertensives, diuretics, acetazolamide, loop diuretics, thiazide diuretics, carbenoxolone. Anticoagulants, salicylates, neuromuscular blockers. 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
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
GROWTH
FAILURE AND ACROMEGALY
deficiencies before treatment. Caution: History of hypoglycaemia, inconsistent food intake; glucagon inj. may be required if a person with severe hypoglycaemia is uncounscious or unable to ingest food normally, doses of insulin and/or other hypoglycaemic agents may need to be reduced. May have insulin-like hypoglycaemic effects; admin shortly before or after a meal or snack. Echocardiogram recommended before initiation, 5NT after treatment and regularly in case of abnormal ALSO GENOTROPIN 5.3MG CARTRIDGE echocardiogram findings. May occur: Lymphoid Somatropin (human growth hormone). 1, tissue hypertrophy associated with complications, A166.49. For use in Genotropin Pen, Genotropin intracranial hypertension with papilloedema, visual Mixer or Genotropin Zip-Tip Needle-Free device. changes, headache, nausea and/or vomiting, 5NT ALSO GENOTROPIN 12MG CARTRIDGE Somatropin slipped capital femoral epiphysis and progression A (human growth hormone). 1, 374.59. For use in of scoliosis in patients who experience rapid Genotropin Pen, Genotropin Mixer or Genotropin growth, local or systemic allergic reactions. Reconsider treatment if patient remains nonZip-Tip Needle-Free device. responsive after a year. Contains benzyl alcohol. 5NT A Thymus hypertrophy, headache, ALSO GENOTROPIN MINIQUICK Somatropin. Powder and solvent for soln. for inj. Two chamber hypoacusis, tonsillar hypertrophy, snoring, hypoglycaemia, injection site hypertrophy. See syringe. Other chamber contains 0.25ml WFI. SPC. Preservative-free single use device, room temp. storage by patient. 0.2mg-7, A47.17; 0.4mg-7, NORDITROPIN SimpleXx A94.37; 0.6mg-7, A141.54; 0.8mg-7, A188.72; Novo Nordisk 1mg-7, A235.90; 1.2mg-7, A283.08; 1.4mg-7, A330.26; 1.6mg-7, A377.44; 1.8mg-7, A424.63; 5NT 2.0mg-7, A471.81. Human growth hormone. Somatropin. Premixed P Initially, 0.15-0.3mg per day. Increase sln. Cartridges: 5mg/1.5ml, A242.09; 10mg/1.5ml, A485.05; 15mg/1.5ml, A533.54. Cartridge for use gradually as determined by IGF-I concentration. Seldom exceeds 1mg daily. with NordiPen 5, 10, 15 resp. and NovoFine Q Admin. by SC inj. Dosage is individual. needles. Inj. device (NordiPen) provided free by GH deficiency: 0.025-0.035mg/kg body weight per Novo Nordisk. S Growth failure due to hormone day (0.7-1mg/m2 body surface per day). Turner’s insufficiency, Turner’s syndrome or chronic renal syndrome/chronic renal insufficiency: 0.0452 0.05mg/kg per day (1.4mg/m ). PWS/SGA: 0.035mg/ disease. Replacement therapy in adults with 2 growth hormone insufficiency. kg daily (1mg/m ); PWS, max. 2.7mg daily. P Start with low dose 0.15-3mg/day (equal D Active tumour. Closed epiphyses in to 0.45-0.9 IU/day). Increase gradually at monthly children treated for growth failure. Acute critical intervals based on clinical response and patient illness. Pregnancy. experience of adverse events. Maintenance doses B Test thyroid function after starting vary considerably, seldom exceed 1mg/day (3 IU/ treatment. Monitor for evidence of glucose day). intolerance. Diabetes mellitus. In SGA children, Q Growth hormone insufficiency: 25measure fasting insulin, blood glucose, IGF-I level 35mcg/kg/day or 0.7-1mg/m2/day, equal to 0.07-0.1 and avoid starting treatment near onset of IU/kg/day (2-3 IU/m2/day). Turner’s syndrome/ puberty. Monitor for respiratory infections. chronic renal disease, 50mcg/kg/day or 1.4mg/m2/ Monitor for: Upper airway obstruction, scoliosis, day equal to 0.14 IU/kg/day (4.3 IU/m2/day). sleep apnoea in patients with PWS. PWS: Ensure D Tumour, pregnancy and lactation, renal effective weight control before and during transplantation. treatment. Chronic renal insufficiency. Elderly, B Monitor for development of diabetes, prolonged treatment. C Caution: Substrates of cytochrome P450. hypothyroidism, slipped capital femoral ephyses, intracranial hypertension. A Adults: Fluid retention, paraesthesia, A Oedema, local inj. site reactions. arthralgia, myalgia, stiffness in the extremities. Children: Transient skin reactions. Both: Formation NUTROPINAQ Ipsen of antibodies. 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.
6.3
lowest efficacious dose. In older or overweight patients, lower doses may be necessary. Q Admin. by 1 daily SC injection rotating injection site. Children with inadequate GH secretion: 0.025-0.035mg/kg bodyweight daily.Turner syndrome: Up to 0.05mg/kg bodyweight daily. Growth failure with CRI: Up to 0.05mg/kg bodyweight daily. D Closed epiphyses. Active neoplasm. Discontinue if evidence of tumour growth develops. Acute critical illness due to complications following open-heart or abdominal surgery, multiple accidental traumas or to treat patients having acute respiratory failure. Pregnancy. B In adults with GH deficiency, confirm diagnosis depending on etiology. Previous malignant disease, history or intracranial lesion. Not indicated for children with growth failure due to Prader-Will syndrome unless GH deficiency diagnosed. Monitor: Evidence of glucose intolerance, progression of renal osteodystrophy (growth failure secondary to CRI), signs of scoliosis (children). Intracranial hypertension may occur. Monitor thyroid function. Terminate treatment following renal transplantation. Lactation. C Caution: Substrates of CYP450. A All indications: Antibody building, hypothyroidism, impaired glucose tolerance, headache, hypertonia, arthralgia, myalgia, oedema, peripheral oedema, injection site reactions, asthenia. Children with inadequate GH 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. 5NT INCRELEX Ipsen Hypersensitivity to ergot alkaloids. Recombinant human growth hormone. 5NT Somatropin 10mg (30 IU). Clear, colourless, sterile B Usage requies regular surveillance. History of peptic ulceration, psychotic or severe sln for inj. 2ml cartridge pack-1, A355.19. Recombinant IGF-1. Mecasermin 40mg. Aqueous, cardiovascular disorders. Perform regular clear and colourless sln for inj. 10mg/m, A704.78. S Children: Long-term treatment of gynaecological assessment for women receiving S Long-term treatment of growth failure growth failure due to inadequate endogenous prolonged therapy. Observe patients on long-term in children and adolescents with severe primary growth hormone (GH) secretion; long-term doses for manifestations of retroperitoneal IGF-1 deficiency (Primary IGFD). treatment of growth failure associated with fibrosis. Q Initially 0.04mg/kg twice daily by SC inj., Turner syndrome; treatment of prepubertal C Alcohol, erythromycin, psychoactive shortly before a meal or snack and rotating inj. children with growth failure associated with agents, drugs effecting BP. sites. May be raised in increments of 0.04mg/kg to chronic renal insufficiency (CRI) up to the time of max 0.12mg/kg twice daily. renal transplantation. Adults: Replacement therapy A Postural hypotension, nausea, vomiting, D IV admin. Active or suspected neoplasia in confirmed GH deficiency of either childhood or mild constipation, dry mouth, leg cramps, hypertension, MI, stroke, drowsiness, confusion, (discontinue if develops). Premature babies or adult-onset etiology. hallucinations, headache, dizziness, seizures, neonates. Pregnancy, lactation. P Admin. by 1 daily SC injection rotating B Not a substitute for GH treatment. Not injection site. Initially 0.15-0.3mg/day. Adjust dose episodes of reversible pallor of fingers and toes induced by cold, psychomotor exitation, to be used for growth promotion in patients with gradually as determined by serum IGF-1 closed epiphyses. Correct thyroid and nutritional concentration. Seldom exceeds 1mg/day. Admin. dyskinesia, retroperitoneal fibrosis. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
165
6.4 DIABETES
HORMONES
MELLITUS
SAIZEN
Merck Serono
5NT Growth hormone. Somatropin 1.33mg, 3.33mg, 8mg. Powder in vials plus diluent. 1.33mg-1, A41.11; 3.33mg-1, A102.79; 8mg Click.easy-1, A265.87. One.click (automatic injector) and Cool.click (needle free) devices free from company. S Growth failure in children due to deficiency of endogenous growth hormone. Turner syndrome. Growth failure in prepubertal children due to chronic renal failure. Replacement therapy in adults with pronounced growth hormone deficiency as diagnosed by a single dynamic test. P Growth hormone defeciency, low doses of 0.15-0.3mg daily by SC inj. Max. 1mg daily. Q Growth hormone deficiency, 0.0250.035mg/kg body weight daily by SC inj. Turner syndrome, 0.045-0.05mg/kg daily by SC inj. Renal failure, 0.045-0.05mg/kg daily by SC inj. D Epiphyseal fusion, tumour. Pregnancy, lactation. B Intracranial lesion, intracranial hypertension, diabetes, ACTH deficiency. Monitor thyroid function. A Hypothyroidism, oedema, pain at inj. site, lipoatrophy.
P Initially 60-120mg every 28 days adjust according to response (as judged by symptomatology and/or biochemical monitoring). 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.
critical illness with complications following abdominal/ open heart surgery, multiple accidental/ trauma, acute respiratory failure or similar. B Intracranial lesion, diabetes, ACTH deficiency. Monitor thyroid function, signs of scoliosis. Renal transplantation (discontinue). Children Q 3years (contains benzyl alcohol). C Caution: Glucocorticoids, androgens, oestrogens or anabolic steroids, insulin, cyto P450 substrates. A Antibodies formation, transient skin reactions.
6.4 DIABETES MELLITUS
ACTOS
Takeda
2MO
Thiazolidinedione. Pioglitazone (HCl) 15mg, 30mg; 45mg. White round tabs. marked 15, 30, or 45 resp. onone side and ACTOS on reverse. 15mg-28, A39.50; 30mg-28, A58.75; 45mg-28, A60.52. SOMAVERT Pfizer S Type 2 diabetes mellitus: 1) as monotherapy in patients inadequately controlled 2NT by diet and exercise for whom metformin is Other anterior pituitary lobe hormones and inappropriate. 2) As combination therapy in analogues. Pegvisomant 10mg, 15mg, 20mg. Vials patients with insufficient glycaemic control with containing white to slightly off white powder and either metformin or sulphonylurea (with solvent for soln. for inj. 10mg-30, A2,647.05; metformin particularly in overweight patients, or SANDOSTATIN Novartis 15mg-30, A3,970.58; 20mg-30, A5,294.11; 20mg-1, with a sulphonylurea only where metformin is A176.60. inappropriate). 3) In combination with metformin 2NT S Acromegaly with inadequate response and a sulphonylurea, in patients (particularly Somatostatin analogue. Octreotide (acetate) 50, to surgery and/or radiation therapy and where overweight patients) with insufficient glycaemic 100, 500mcg per ml. Soln. in vials. 50mcg-5 x 1ml, treatment with somatostatin analogues did not control despite dual oral therapy. 4) In A20.79; 100mcg-5 x 1ml, A39.12; 500mcg-5 x 1ml, normalise IGF-1 concentrations or was not combination with insulin in patients with A189.51. tolerated. insufficient glycaemic control on insulin for whom S Acromegaly. P Initially, 80mg loading dose admin. as metformin is inappropriate. P 100-200mcg three times daily by SC inj. SC inj., followed by 10mg reconstituted in 1ml of P Initially, 15-30mg once daily; may be Q Not recommended. solvent by SC inj. once daily. Adjust dose in 5mg/ increased in increments up to 45mg once daily. In 2NT day increments based on serum IGF-1 levels . Max. combination with insulin, current insulin dose can ALSO SANDOSTATIN LAR Octreotide (acetate) R 30mg/day. be continued. If hypoglycaemia occurs, decrease 10mg, 20mg, 30mg. Microspheres for susp. 4Q No experience. insulin dose. weekly depot inj. 10mg-1, A899.00; 20mgB Growth hormone-secreting pituitary Q Under 18 years, not recommended. 1,A1198.66; 30mg-1, A1498.33. tumours. Monitor: Serum IGF-1 concentrations, D Cardiac failure (or history of) NYHA S Treatment of acromegaly in patients serum ALT, serum AST. Liver disease, diabetes stages I to IV, hepatic impairment, diabetic controlled by subcutaneous Sandostatin in whom mellitus. Potential increased female fertility, advise ketoacidosis. Pregnancy, lactation. surgery, dopamine agonists or radiotherapy are adequate contraception. Pregnancy (unless clearly B Can cause fluid retention; monitor for ineffective or inappropriate, or in interim period necessary), lactation. HF and discontinue if deterioration in cardiac until radiotherapy becomes effective. C Insulin, oral hypoglycaemic agents. May status. Caution, over 75 years. Monitor weight P When control established, initially 20mg affect growth hormone assays. gain. Check liver enzymes prior to initiation and by deep intragluteal inj. every 4-weeks for 3 A Headache, dizziness, somnolence, periodically thereafter; do not initiate if ALT q months. Admin. by deep intragluteal inj. only. tremor, GI disorders, sweating, pruritis, rash, 2.5xULN and discontinue if ALT remains q 3xULN Adjust subsequent doses according to levels of GH arthralgia, myalgia, peripheral swelling, or if jaundice occurs. Long term use: Consider risk or IGF-1 and clinical response. hypercholesterolemia, weight gain, hyperglycemia, of fractures. Q Not recommended. hunger, hypertension, influenza, fatigue, injection C Gemfibrozil, rifampicin. B Use only under hospital specialist site bruising/bleeding/reaction/hypertrophy, A Visual disturbance, upper RTI, weight supervision. Pregnancy, lactation. Diabetics may abnormal liver function tests, abnormal dreams, increase, hypoaesthesia. Also with metformin: show reduced hypoglycaemic requirements. In sleep disorder. Anaemia, arthralgia, headache, haematuria, long term therapy, monitor thyroid and hepatic erectile dysfunction. With sulphonylurea: ZOMACTON Ferring function, gall stone development. Flatulence, dizziness, weight gain, increase in C Cyclosporin, cimetidine, bromocriptine. creatinine phospokinase. With insulin: 5NT A Inj. site reactions, GI upset, gall stones, Growth hormone. Somatropin (rbe) 4mg. Powder Hypoglycaemia, oedema, bronchitis, back pain, biliary colic. Rarely persistent hyperglycaemia. arthralgia, dyspnoea, HF, weight increase. A in vial plus diluent. 1, 102.57. Hepatitic dysfunction. S Growth failure in children due to Novo Nordisk deficiency of endogenous growth hormone. Long- ACTRAPID SOMATULINE AUTOGEL Ipsen 5MO term treatment of growth retardation due to 2NT Fast-acting human soluble insulin. Insulin 100 IU/ Turnerâ&#x20AC;&#x2122;s syndrome confirmed by chromosome ml. 10ml. 1, A11.03. Somatostatin analogue. Lanreotide (acetate) analysis. S Diabetes mellitus. 60mg, 90mg, 120mg. Pre-filled syringe. 60mg-1, P Not applicable. A900.48; 90mg-1, A1199.54; 120mg-1, A1548.44. V By SC, IM or IV inj. in accordance with Q GH deficiency: 0.17-0.23mg/kg body individual requirements. Duration approx. 8 hrs weight per week divided into 6-7 SC inj.; max. S Treatment of acromegaly when the following SC inj. 0.27mg/kg weekly. Turnerâ&#x20AC;&#x2122;s syndrome: 0.33mg/kg level of growth hormone and IGF-l remains D Hypoglycaemia. abnormal after surgery and/or radiotherapy, or in body weight per week divided into 6-7 SC inj. D Epiphyseal fusion, tumour, pregnancy, patients requiring treatment before such AMARYL sanofi-aventis lactation. Premature babies, neonates. Acute intervention.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES
DIABETES
MELLITUS
6.4
Monitor for fluid retention, other signs of cardiac failure. Monitor liver enzymes prior to initiation and periodically thereafter. Lactic acidosis (discontinue if suspected). Monitor weight. Discontinue 48 hrs before surgery and resume 48 hrs after. Contains lactose. C Discontinue before IV inj. of iodinated contrast agents and resume 48 hrs after. Not reommended: Insulin (use only in exceptional cases and under close supervision). Avoid alcohol. Caution: Gemfibrozil, rifampicin, other CYP2C8 inducers, glucocorticoids, b-2-agonists, diuretics, ACE inhibitors. A Anaemia, GI upset, hypoglycaemia, APROVEL sanofi-aventis/BMS weight gain, oedema, cardiac ischaemia, hypercholesterolaemia. 2MO Angiotensin II antagonist. Irbesartan 75mg,150mg, AVANDIA GSK 300mg. White oval tabs. marked with heart 2NO symbol and 2771, 2772 or 2773 resp. 75mg-28, A16.49; 150mg-28, A18.33; 300mg-28, A24.74. Thiazolidinedione. Rosiglitazone (maleate) 4mg, S Renal disease in patient with 8mg. Orange, red/brown film-ctd tabs marked hypertension and type 2 diabetes mellitus. with SB and strength. 4mg-28, A35.36; 56, P Initially 150mg once daily and titrate up A70.71; 8mg-28, A63.78. to 300mg once daily. Haemodialyses patients S Oral monotherapy treatment of type 2 consider using initial dose of 75mg once daily. diabetes in patients (particularly overweight R Over 75 years, initiate with 75mg once patients) inadequately controlled by diet and daily. exercise for whom metformin is inappropriate. In D Pregnancy. dual/triple therapy combination with metformin B Renovascular hypertension, renal and/or sulphonylurea. impairment, hyperkalaemia, aortic or mitral valve P Initially 4mg daily. Monotherapy and stenosis, obstructive hypertrophic cardiomyopathy, combination therapy with metformin/ primary aldosteronism. If inadvertently taken sulphonylurea: Increase to 8mg daily after 8 weeks during pregnancy, check skull and renal function if greater glycaemic control required. with echography. Lactation not recommended Q Under 18 years, not recommended. (esp. newborn or preterm infants). Contains D Cardiac failure or history of cardiac lactose. failure (NYHA class I to IV), Acute Coronary + + C K sparing diuretics, K suppl., lithium. Syndrome (unstable angina, NSTEMI and STEMI), A Headache, musculo-skeletal trauma, hepatic impairment, raised liver enzymes, diabetic flushing. 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 APIDRA sanofi-aventis 500mg, 2mg/1000mg, 4mg/1000mg. Film-ctd tabs. marked gsk on one side. Yellow, pale pink, yellow initiation and periodically thereafter. Monitor 5MO weight gain, Hb levels. and pink marked 1/500, 2/500, 2/1000 and 4/1000 C Not reommended: Insulin (use only in Rapid acting insulin analogue. Insulin glulisine resp. on reverse. 1mg/500mg-112, A32.10; 2mg/ 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. soln for inj. Pre-filled pens: Optiset 5 x 3ml, A35.70; 4mg/1000mg-56, A65.45. A39.00; SoloStar 5 x 3ml, A33.41. Cartridges: 5 x A Hypercholesterolaemia, anaemia S Type 2 diabetes mellitus patients, 3ml, A39.00. Vial 1 x 10ml, A25.99. particularly overweight patients, unable to achieve (monotherapy). Hypoglycaemia, anaemia, GI S Diabetes mellitus where insulin is sufficient glycaemic control at maximally tolerated disorders (with metformin). Hypoglycaemia, thrombocytopenia, anaemia, hyperlipidaemia , required. dose of oral metformin alone. weight increase, oedema, dizziness (with P Admin. shortly (0-15 min) before or P Initially, 2mg/1000mg twice a day. May soon after meals by SC inj. in abdominal wall, be increased to 8mg/day after 8 weeks if required. sulphonylureas). 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. Q Under 6 years, not recommended. 6 5NO 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), dehydration, severe infection, shock, intravascular P Initially 5mcg twice daily, for at least 1 PRESCRIBING NOTES month. Can then increase to 10mcg twice daily. administration of iodinated contrast agents. DIABETES Doses q 10mcg twice daily, not recommended. Pregnancy, lactation. All insulin-dependent diabetic athletes are Admin. as SC inj. in thigh, abdomen, or upper B Ischaemic heart disease and/or required to apply for a standard Therapeutic Use arm, within 60 min. before morning and evening peripheral arterial disease (not recommended). Exemption (TUE) to cover their insulin use. See Monitor renal function at least once a year, and 2- meal. When added to metformin therapy, Summary of WADA list. continue current metformin dose. When added to 4 times a year in elderly or patients at risk.
2NO
Sulphonylurea. Glimepiride (INN) 1mg, 2mg, 3mg, 4mg. Pink, green, light-yellow and light-blue oblong tabs. resp. All scored on both sides. 1mg30, A3.37; 2mg-30, A5.86; 3mg-30, A11.85; 4mg30, A9.47. S Type II diabetes mellitus. P 1mg daily increasing at 1-2 week intervals to 2mg, 3mg or 4mg daily. Max. 6mg daily. Take tabs. before or during first main meal. Renal impairment, see SPC. Q Not recommended. D Insulin dependent diabetes, diabetic coma, ketoacidosis, severe renal and liver insufficiency. B Elderly, endocrine disorders, stress, G6PD-deficiency, Lapp lactase deficiency. Pregnancy, lactation. Avoid hypoglycaemia while driving. C Phenylbutazone, azapropazone, oxyfenbutazone. Insulin and oral antidiabetic products. Salicylates and PA salicylic acid, anabolic steroids and male sex hormones, chloramphenicol, certain long acting sulfonamides, tetracyclines, quinolone antibiotics and clarithromycin. Coumarin anticoagulants, fenfluramine, fibrates, ACE inhibitors, fluoxetine, MAO-inhibitors. Allopurinol, probenecid, sulfinpyrazone, sympatholytics. Cyclophosphamide, trophosphamide and iphosphamides. Miconazol, fluconazole, pentoxifylline (high dose parenteral). Tritoqualine. Oestrogens, progestogens, saluretics, 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.
lactation. Avoid hypoglycaemia while driving. C Oral antidiabetic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, propoxyphene, salicylates, sulphonamides. Corticosteroids, danazol, diazoxide, diuretics, glucagons, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics, thyroid hormones, estrogens, progestins, protease inhibitors, atypical antipsychotics, b-blockers, clonidine, lithium, alcohol, pentamidine guanethidine, reserpine. A Hypoglycaemia, inj. site reactions, local hypersensitivity reactions.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
167
6.4 DIABETES
HORMONES
MELLITUS 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, Takeda erectile dysfunction, oedema, upper RTIs, hypoaesthesia, taste disturbance, GI disorders.
sulphonylurea therapy, consider sulphonylurea dose reduction. Moderate renal impairment: Caution, increasing 5mcg-10mcg. R Caution, increasing 5mcg-10mcg in patients q70 years. Over q 75 years, limited experience. Q Under 18 years, not recommended. D Pregnancy, lactation. B Not for use in Type 1 diabetes, diabetic ketoacidosis or Type 2 diabetes patients who require insulin. IV/IM inj., not recommended. Endstage renal disease or severe renal impairment (ccQ30ml/min), severe GI disease; not recommended. Patients with BMI R 25, limited experience. May rarely occur: Altered renal function, acute pancreatitis (discontinue if occurs); resolution of pancreatitis has been observed with supportive treatment but very rare cases of necrotizing or hemorrhagic pancreatitis and/or death reported. Contains metacresol. Avoid hypoglycaemia while driving/using machines. C Not recommended: Insulin, Dphenylalanine derivatives, meglitinides, aglucosidase inhibitors; no data. Caution: Oral medicines requiring rapid GI absorption, or with a narrow therapeutic ratio, or dependent on threshold concentrations for efficacy; see SPC. Gastro-resistant formulations containing substances sensitive for degradation in the stomach e.g. PPIs, take r 1 hour before or q 4 hours after. Caution: Warfarin/cumarol derivatives. A Hypoglycaemia, decreased appetite, headache, dizziness, GI disorders, hyperhidrosis, feeling jittery, asthenia.
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 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. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorbtion. 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.
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 2MO inadequately to dietary measures. Thiazolidinedione/biguanide Pioglitazone (HCI) COZAAR MSD P Initially 5mg once daily at breakfast. 15mg, metformin (HCI) 850mg. White, oblong, Adjust at weekly intervals to max. 15mg daily, if 2MO film-ctd tab., marked 15/850 on one face and necessary. Angiotensin II antagonist. Losartan (K+) 12.5mg, 4833M on reverse. 56, A48.10. Q Not applicable. S Type 2 diabetes mellitus, particularly in 50mg, 100mg. White film-ctd scored tab. marked D Diabetic ketoacidosis, diabetic coma/pre952, white film-ctd teardrop-shaped tab. marked overweight patients, who are unable to achieve coma, type 1 diabetes, renal, hepatic or sufficient glycaemic control at their max. tolerated 960. 12.5mg-28, A9.60; 50mg-28, A18.32; 100mgadrenocortical impairment, circumstances of 28, A30.80. dose of oral metformin alone. unusual stress (e.g. surgical operations). P One tab., taken twice a day. Take with, 2 M O Sulphonylurea or sulphonamide intolerance. Brittle ALSO COZAAR ORAL SUSPENSION Losartan K+, or just after food. Consider dose titration with or juvenile diabetes, pregnancy, lactation, 2.5mg/ml (reconstituted susp.). White to off-white children, treatment with bosentan. pioglitazone (added to optimal metformin dose) B Stress situations (e.g. trauma, surgery, PRESCRIBING NOTES infection): may be necessary to discontinue and Interaction between insulin and other medicinal products admin insulin. G6PD deficiency. Risk of A number of substances are known to interact with glucose metabolism. When administered in diabetic hypoglycaemia or haemolytic anaemia. Contains patients in combination with insulin, insulin dosage may need to be adjusted. lactose. Substances that have a hyperglycaemic activity and may increase insulin requirements: C Bosentan (contra). Insulin, other oral oral contraceptives anti-diabetics, ACE inhibitors, anabolic steroids, thiazides male sex hormones, chloramphenicol, coumarin glucocorticoids derivatives, cyclophosphamide, disopyramide, thyroid hormones fenfluramine, fenyramidol, fibrates, fluoxetine, sympathomimetics ifosfamide, MAOIs, miconazole, PAS acid, danazol pentoxifylline, phenylbutazone, azapropazone, Substances that have a hypoglycaemic activity and may decrease insulin requirements: oxyphenbutazone, probenecid, quinolones, oral hypoglycaemics, salicylates, sulphinyrazone, sulfonamides, octreotide, lanreotide sympatholytic agents, b-blockers, guanethidine, certain antidepressants (MAOIs, SSRIs) clarithromycin, tetracyclines, tritoqualine, non-selective b-blockers trosfosfamide. Acetazolamide, barbiturates, certain ACE inhibitors (captopril, enalapril) corticosteroids, diazoxide, diuretics, epinephrine angiotensin II receptor blockers and other sympathomimetic agents, glucagon, salicylates laxatives, nicotinic acid, oestrogens, progestogens, alcohol phenothiazines, phenytoin, thyroid hormones, anabolic steroids rifampicin, H2-receptor antagonists, clonidine, sulphonamides reserpine, cyclosporine, alcohol. Keep in mind that b-blocking agents may mask the symptoms of hypoglycaemia and alcohol may A Hypoglycaemia, temporary visual intensify and prolong the hypoglycaemic effect of insulin. impairment, gastrointestinal disturbances, liver Updated August 2007. function disturbances, cholestatic jaundice,
COMPETACT
168
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
HORMONES DIA 30 on reverse. 60, A7.09. S Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise DIABREZIDE Helsinn Birex and weight loss alone are not sufficient to control blood glucose. 2MO Sulphonylurea. Gliclazide 80mg. White scored tab. P 1-4 once daily with breakfast, depending on response. 60, A4.87. Q Not applicable. S Treatment of type II diabetes mellitus, D See SPC. inadequately controlled by non-pharmaceutical means. EUCREAS Novartis P v-1 daily increasing to a max. of 4 daily 2MO where necessary. Daily doses of 2 tabs. or more should be taken in 2 divided doses. DPP-4 inhibitor/biguanide. Vildagliptin 50mg; Q Not recommended. metformin HCl 850mg (eq. to metformin 660mg) D See SPC. or 1000mg (eq. to metformin 780mg). Resp. yellow or dark yellow, ovaloid film-ctd tab. with DIACLIDE Gerard bevelled edge, imprinted with NVR one side and SEH or FLO the other. 50mg/850mg-60, A46.18; 2MO Sulphonylurea. Gliclazide 80mg. White scored tab. 50mg/1000mg-60, A46.18. S Treatment of type 2 diabetes mellitus marked GZ80 one side and G on reverse. 60, patients unable to achieve sufficient glycaemic A5.04. control at their max tolerated oral metformin dose S Treatment of maturity onset diabetes mellitus, where insulin therapy is not required and alone or who are already treated with the combination of vildagliptin and metformin as dietary modifications have failed to control separate tabs. hyperglycaemia. P Initially, either one 50mg/850mg or P 40-320mg total daily dose. Single dose should not exceed 160mg, when higher doses are 50mg/1000mg tab. strength twice daily (1 tab. morning; 1 tab. evening), based on patient’s required dose should be divided twice daily with main meals and in conjunction with a calorie and current metformin dose. Recommended daily dose: 100mg vildagliptin + 2000mg metformin HCl. carbohydrate restricted diet. May be used in Patients receiving vildagliptin and metformin from combination with biguanide if necessary. separate tabs may be switched to Eucreas Q Not recommended. containing same doses of each. Doses q 100mg D See SPC. vildagliptin not recommended. No clinical DIAGLYC Teva experience of vildagliptin and metformin in triple combination with other antidiabetics. Taking 2MO Eucreas with or just after food may reduce GI Sulphonylurea. Gliclazide 30mg. White, oval, symptoms. biconvex modified-release tab. 60, A 6.03. R Monitor renal function regularly. q 75 S Non insulin-dependent diabetes (type 2) years, not recommended. in adults when dietary measures, physical exercise Q Not recommended. and weight loss alone are not sufficient to control D Diabetic ketoacidosis or diabetic preblood glucose. coma. Renal failure/dysfunction (ccQ 60 ml/min). P 30-120mg in a single intake at breakfast Acute conditions with potential to alter renal time. Initially 30mg daily. If blood glucose is not function, (dehydration, severe infection, shock, adequately controlled, the dose may be increased intravascular administration of iodinated contrast in successive steps to 60, 90 or 120mg daily. agents). Acute or chronic disease which may cause Switching from 80mg immediate release tablet: tissue hypoxia (cardiac or respiratory failure, Monitor blood glucose carefully. Patients at risk of recent MI, shock). Hepatic impairment. Acute hypoglycaemia: 30mg. Switching from other oral alcohol intoxication, alcoholism. Lactation. antidiabetics and in combination with other Pregnancy. antidiabetics: See SPC. B Not for type 1 diabetes. Lactic acidosis Q Under 18 years, not recommended. may occur (discontinue and hospitalise if D Type 1 diabetes. Diabetic pre-coma and suspected). Monitor serum creatinine coma, diabetic keto-acidosis. Severe renal or concentration regularly (once a year in patients hepatic insufficiency. Treatment with miconazole. with normal renal function; 2 to 4 times a year if Lactation. Pregnancy. serum creatinine levels at the upper limit of B Hepatic insufficiency, severe renal normal and in elderly). Monitor liver function failure. Careful selection of patients needed to before and during treatment (at 3-month intervals reduce risk of hypoglycaemic episodes. Contains during the first year and periodically thereafter). If lactose. transaminase levels increase, frequent monitoring C Contra: Miconazole. Not recommended: required until levels return to normal; withdrawal Phenylbutazone, alcohol, danazol. Caution: Other recommended if AST or ALT levels of 3x ULN or antidiabetics, b-blockers, fluconazole, angiotensin greater persist. Discontinue if jaundice or other converting enzyme inhibitors (captopril, enalapril), signs suggestive of liver dysfunction occur. Not H2-receptor antagonists, MAOIs, sulfonamides, recommended: CHF NYHA Class III-IV. Caution: CHF NSAIDs, chlorpromazine, glucocorticoids, ritodrine, NYHA Class I-II. Monitor for skin disorders, such as salbutamol, intravenous terbutaline, anticoagulant blistering or ulceration. Discontinue 48 hours therapy (e.g. warfarin). before elective surgery with general anaesthesia A Hypoglycaemia. and for 48 hours afterwards. C Not recommended: Iodinated contrast DIAMICRON MR Servier media. Avoid alcohol. Cationic active substances 2MO eliminated by renal tubular secretion (e.g. cimetidine). Caution: Glucocorticoids, b2-agonists, Sulphonylurea. Gliclazide 30mg. Modified release white oblong tab. marked with logo one side and diuretics, ACE inhibitors, thiazides, corticosteroids, changes in blood picture, purpura, skin rashes, allergic vasculitis, photosensitivity.
DIABETES
MELLITUS
6.4
thyroid products and sympathomimetics, antihypertensive, diuretic, NSAID. A Tremor, headache, dizziness, fatigue, GI disorders, metallic taste, hypoglycaemia.
GALVUS
Novartis
2MO DPP-4 inhibitor. Vildagliptin 50mg. White to light yellowish, round (8mm diameter), flat-faced, bevelled-edge tab. debossed with NVR one side, FB the other. 56, A43.10. S Type 2 diabetes mellitus. As dual oral therapy in combination with: metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin; a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance; a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate. P Wth metformin or a thiazolidinedione: 100mg (50mg morning; 50mg evening). With a sulphonylurea: 50mg once daily (morning). Safety and efficacy not established as triple oral therapy in combination with metformin and a thiazolidinedione or with metformin and a sulphonylurea. R r75 years, caution. Q Not recommended. D Pregnancy, lactation. B Not for type 1 diabetes or diabetic ketoacidosis. Not recommended: Moderate to severe renal impairment; patients with end-stage renal disease on haemodialysis, hepatic impairment (including patients with pre-treatment ALT or AST q 3x ULN), CHF of NYHA class III-IV. Monitor liver function before and during treatment (at 3-month intervals during 1st year and periodically thereafter). If transaminase levels increase, frequent monitoring required until return to normal; withdrawal recommended if AST or ALT levels of 3x ULN or greater persist. Discontinue if jaundice or other signs suggestive of liver dysfunction occur. Caution: Congestive heart failure of NYHA functional class I-II. Monitor for skin disorders, such as blistering or ulceration. Hepatic dysfunction (incl. hepatitis) and angioedema reported rarely. Contains lactose. C Hypoglycaemic effect may be reduced by thiazides, corticosteroids, thyroid products, sympathomimetics. A With metformin: Hypoglycaemia, tremor, headache, dizziness, fatigue, nausea. With a sulphonylurea: Hypoglycaemia, tremor, headache, dizziness, asthenia. With a thiazolidinedione: Weight increase, oedema peripheral.
GLIBENESE
Pfizer
2MO Sulphonylurea. Glipizide 5mg. White, capsularshaped, 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
169
6.4 DIABETES
HORMONES
MELLITUS
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. B Lactic acidosis (discontinue if suspected). GLUCAGEN HYPOKIT Novo Nordisk Impaired renal function. Monitor serum cc levels at least annually if normal renal function, and 2-4 2NO times a year if cc levels at ULN and in elderly. Hyperglycaemic. Glucagon 1mg. Lyophilised Children (especially pre-pubescent), general powder in vials plus solvent in syringe and vial. anaesthesia (within 48 hrs). 1mg vial plus solvent in syringe A19.19. C Not recommended: Iodinated contrast S Diabetic hypoglycaemia. agents, alcohol. Caution: Insulin, sulfonylureas, V 1-2mg SC, IM or IV; may be repeated glucocorticoids, b2-agonists, ACE inhibitors, after 20 minutes. antihypertensives, diuretics, NSAIDs. D See SPC. A Taste disturbance, GI disorders.
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.
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 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,
170
A1.96;
HUMALOG
Lilly
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.
HUMALOG MIX 25
Lilly
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.
5MO 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.
INSULATARD
Novo Nordisk
5MO
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.
Intermediate-acting insulin. Insulin isophane inj. 100 IU/ml. Vial. 1x10ml, A11.03.
5MO ALSO HUMALOG MIX 50 Insulin lispro (50% insulin lispro soln.; 50% insulin lispro protamine
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
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
DIABETES
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.
JANUMET 2MO
MSD
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) b2agonists, 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
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 JANUVIA and exercise in patients inadequately controlled 2MO on their max. tolerated metformin dose alone or
MELLITUS
6.4
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 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, MSD pentoxifylline, propoxyphene, salicylates, sulphonamides. Corticosteroids, danazol,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
171
6.4 DIABETES
HORMONES
MELLITUS
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, P 10mg once daily; may be increased to 20mg. Slightly red scored tabs. 5mg-30, A8.13; 20mg once daily if necessary. Renal impairment, 10mg-30, A10.03; 20mg-30, A11.51. ccQ10ml/min, initially 2.5mg; 10QccQ30ml/min, S Early nephropathy in diabetics. initially 2.5-5mg; 31QccQ80ml/min, initially 5P Initially 10mg once daily, increasing to 10mg/day. 20mg once daily if necessary. Q Not recommended. R Initially 2.5mg increasing to 5-10mg D History of angioedema associated with once daily. previous ACE inhibitor therapy. Hereditary or Q Not recommended. idiopathic angioedema. Pregnancy, lactation. D History of angioneurotic oedema B Caution: Acute MI (do not use: Renal related to previous ACE-inhibitor treatment. dysfunction, systolic BP R100mmHg, cardiogenic Pregnancy, lactation. shock), mitral stenosis and left ventricle outflow B Renal impairment, hypotension (1st obstruction (aortal stenosis, hypertrophic dose), aortic stenosis, acute MI, multiple or high myocardiopathy), bilateral renal artery stenosis or dose diuretic therapy. stenosis of the artery in a single kidney (strict C K+ suppl., antihypertensive agents, supervision with low doses; careful dose sympathomimetics, lithium, antacids, NSAIDs, adjustment), pre-existing renal impairment alcohol, anaesthetics, narcotics, hypnotics, oral (monitor blood K+, creatinine), major surgery, hypoglycaemic agents, diuretics, NaCl. anaesthesia, renal insufficiency, diabetes. May A Hypotension, dry cough, sore throat, occur: Systemic hypotension, angioedema bronchitis, dizziness, feeling weak, impaired vision, (withdraw immediately if occurs), anaphylactoid nausea, stomach pain, indigestion, rash, headache, reactions in haemodialysis patients or during tiredness, palpitations, renal failure. desensitisation treatment, acute renal insufficiency in patients with HF (usually reversible), hepatic LOAVEL sanofi-aventis 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, A5.29; acid r 3g/day), other antihypertensives, injectable 2.5mg-28, A7.48; 5mg-28, A10.41; 10mg-28, gold, certain anaesthetic drugs, TCAs, A14.13. antipsychotic agents, sympathicomimetics, antiS Non diabetic and diabetic overt/ diabetics. incipient nephropathy. Prevention of progression A Dizziness, headache, cough, diarrhoea, of microalbuminuria to overt nephropathy. vomiting, renal dysfunction, orthostatic effects P Non diabetic and diabetic overt/ (incl. hypotension). incipient nephropathy: Initially 1.25mg once daily LEVEMIR Novo Nordisk titrate according to response; max. 5mg once daily. Discontinue diuretic at least 2-3 days. 5MO Hepatic impairment, max. 2.5mg once daily. Long-acting insulin analogue. Insulin detemir 100 Prevention of progression of microalbuminuria to U/ml (recombinant DNA origin, S. cerevisiae). 1 U overt nephropathy: Initially 2.5mg once daily 1 IU human insulin. Soln. for inj. in 3ml preincreasing gradually to double the dose after 1 filled pen (FlexPen) or penfill cartridge for use week and after another 3 weeks to 10mg usual with NovoPen 3 metered dose inj. device. FlexPen: maintenance dose. 5x3ml, A54.43. Cartridge: 5x3 ml, A52.87. R Consider initial dose of 1.25mg daily. NovoPen 3 supplied free of charge by Novo Titrate according to need for BP control. Nordisk, tel. 1850 665 665. Q Not recommended. S Diabetes mellitus. D History of angiooedema. Aortic stenosis 5MO or outflow obstruction. Renal artery stenosis, ALSO LEVEMIR INNOLET Insulin detemir 100 U/ml. hypotensive or haemodynamically unstable states. Pre-filled multi-dose injection device. 5 x 3ml, Pregnancy, lactation. A51.76. B CHF, hepatic impairment, blood S Diabetes mellitus. dyscrasias. Renal impairment: Reduce dose and P Once or twice daily by SC inj. If twice assess renal function prior to and during daily, 2nd dose in the evening or at bedtime. In treatment. Caution: Patients with hyper stimulated 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.
172
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.
MIXTARD 30
Novo Nordisk
5MO Premixed insulin. Insulin mixture, 3 parts soluble to 7 parts isophane insulin 100 IU/ml. Vial. 1 x 10ml, A11.03.
5MO ALSO MIXTARD 30 PENFILL Insulin as isophane insulin 100 IU/ml. Cartridge 5 x 3ml, A30.48. NovoPen 3 supplied free of charge by Novo Nordisk, freephone 1850 665 665.
5MO ALSO MIXTARD 30 INNOLET Insulin as isophane insulin 100 IU/ml. 3ml pre-loaded multi-dose inj. device. 5, A35.73. S Diabetes mellitus. V By SC inj. In accordance with individual requirements. Duration approx. 24 hrs. D Hypoglycaemia.
NOVOMIX 30 FLEXPEN
Novo Nordisk
5MO Biphasic insulin analogue. Soluble insulin aspart/ protamine-crystallised insulin aspart 100 U/ml in the ratio of 30/70. (Recombinant DNA origin, S. cerevisiae) in a pre-filled disposable pen comprising a pen injector with a 3ml cartridge. 5 x 3ml, A42.47.
5MO ALSO NOVOMIX 30 PENFILL Soluble insulin aspart/ protamine-crystallised insulin aspart 100 IU/ml in the ratio of 30/70. (Recombinant DNA origin, S. cerevisiae) in a 3ml cartridge for use with NovoPen 3 metered dose inj. device. Cartridge-5 x 3ml, A38.45; NovoPen 3 supplied free of charge by NovoNordisk phone 1850 665 665. S Diabetes mellitus. P Dosage is individualised according to patient need. NovoMix 30 should be given immediately before or immediately after a meal. Q Can be used in children aged 10 years and older. D Hypoglycaemia.
NOVONORM
Novo Nordisk
2MO Prandial glucose regulator. Repaglinide 0.5mg, 1mg, 2mg. White, yellow and red tabs. 0.5mg-120, A30.58; 1mg-120, A33.07; 2mg-120, A35.53. S Type 2 diabetes (monotherapy). Also in combination with metformin. P Initial dose, 0.5mg before each main meal (1mg is the max. recommended starting dose if transfered from another oral hypoglycaemic agent). Allow 1-2 weeks between titration steps, as determined by blood glucose response. Maintenance, max. single dose 4mg with main meals. Total max. daily dose should not exceed 16mg. Combination with metformin, maintain metformin dose and admin. repaglinide concomitantly, starting dose 0.5mg.
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
THYROID
HORMONES AND ANTITHYROID DRUGS
6.5
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).
A Nausea, vomiting, dizziness, fatigue, headache, abdominal pain, diarrhoea, cough. Liver dysfunction, renal impairment, hypersensitivity reactions. Rarely, symptomatic hypotension, angioneurotic oedema, syncope.
STARLIX
VICTOZA
NOVORAPID FLEXPEN
2NO
Novo Nordisk
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, A28.28; 180mg-84, A28.28. 5MO ALSO NOVORAPID PENFILL Insulin aspart. 100 IU/ S Combination therapy with metformin in type 2 diabetic patients inadequately controlled ml. (Recombinant DNA origin, S. cervisiae)in 3ml with max. tolerated dose of metformin alone. cartridge for use with NovoPen 3 metered dose 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 supplied free of charge by Novo Nordisk, phone three times daily taken within 1-30 minutes before 1850 665 665. meals. Max. single dose is 180mg taken before the 5MO three main meals. ALSO NOVORAPID VIAL Insulin aspart. 100IU/ml. Recombinant DNA (origin, S. cerevisiae) in a 10ml Q Under 18 years, not recommended. D Type I diabetes, diabetic ketoacidosis, vial. 1 x 10ml, A22.45. with or without coma, severe hepatic impairment. S Diabetes mellitus. Pregnancy, lactation. V Dosage individualised in accordance B Moderate hepatic impairment. Elderly. with patient need. NovoRapid should be given Should not be used as monotherapy. immediately before or immediately after a meal. Hypoglycaemia. Under 2 years, no data. C ACE inhibitors, diuretics, corticosteroids, D Hypoglycaemia. B Avoid hypoglycaemia whilst driving. Can b2-agonists. A Hypersensitivity reactions, elevation in be used in pregnancy (monitor), lactation (adjust liver enzymes. dose). C Substances that may affect insulin TRITACE sanofi-aventis requirements: See prescribing note.
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.
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, A4.31; 2.5mg-28, A6.10; 5mg-28, A8.50; 10mg-28, A11.57. S Non diabetic and diabetic overt/ ONGLYZA BMS/AstraZeneca incipient nephropathy. Prevention of progression 2 of microalbuminuria to overt nephropathy. DPP-4 inhibitor. Saxagliptin (HCl) 5mg. Pink, P Non diabetic and diabetic overt/ biconvex, round, film-ctd tab., with 5 printed on incipient nephropathy, the initial dose is 1.25mg one side and 4215 on the other. 28, A38.47. once daily titrate according to response; max. 5mg S Add-on therapy in adults with type 2 one daily. Discontinue diuretic at least 2-3 days. diabetes mellitus: With metformin, when Hepatic impairment, max. 2.5mg once daily. metformin alone, with diet and exercise, does not Prevention of progression of microalbuminuria to provide adequate glycaemic control; with a overt nephropathy, the initial dose is 2.5mg once sulphonylurea, when the sulphonylurea alone, daily increasing gradually to double the dose after with diet and exercise, does not provide adequate 1 week and after another 3 weeks to 10mg usual glycaemic control in patients for whom metformin maintenance dose. is inappropriate. With a thiazolidinedione, when R No special dosage recommendations for the thiazolidinedione alone with diet and exercise, elderly patients apart from general warning about does not provide adequate glycaemic control in patients with renal or hepatic insufficiency or CHF patients for whom a thiazolidinedione is which may be common in elderly and concomitant considered appropriate. use of diuretic drugs. Dose titrated according to P 5 mg once daily as add-on therapy. need for BP control. Safety and efficacy not established as part of Q Not recommended. triple therapy. D History of angioneurotic oedema. Aortic Q Not recommended. stenosis, outflow obstruction. Pregnancy, lactation. D Pregnancy (unless necessary), lactation. Hypersensitivity to ramipril. B Not for type 1 diabetes mellitus or for B CHF, hepatic impairment, blood the treatment of diabetic ketoacidosis. Not dyscrasias. Renal impairment: reduce dose and recommended: Moderate to severe renal assess renal function prior to and during impairment, severe hepatic impairment. Safety not treatment. Haemodialysis (avoid in patients established: Cardiac failure (NYHA class III-IV), dialysed with high flux membranes). Use with immunocompromised. Caution: Moderate hepatic caution in surgery and during anaesthesia. impairment, elderly, NYHA class I-II. Monitoring C Antihypertensive agents, K+sparing diuretics, K+suppl., lithium, antidiabetic agents, for skin disorders (blistering, ulceration or rash) NSAIDs. recommended. Contains lactose.
Novo Nordisk
5MO Human GLP-1 analogue. Liraglutide 6mg/ml. Clear, colourless, isotonic sln for inj. in pre-filled pen. 2, A89.06; 3, A133.59. S Type 2 diabetes mellitus in adults, to achieve glycaemic control. In combination with metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea. In combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy. P Admin by SC inj. in the abdomen, thigh or upper arm, once daily preferably at same time every day. Initially, 0.6mg. Allowing minimum 1 week intervals, increase to 1.2mg and if necessary to 1.8mg max. In combination with a sulphonylurea, consider reducing sulphonylurea dose (risk of hypoglycaemia, blood glucose selfmonitoring may be necessary). Hepatic impairment/moderate to severe renal impairment: Not recommended. R r75 years, limited therapeutic experience. Q Under 18 years, not recommended. D Pregnancy, lactation. B Not for type 1 diabetes or diabetic ketoacidosis. Caution: CHF NYHA class I-II (limited experience), NYHA class III-IV (no experience). Not recommended: IBD, diabetic gastroparesis. Risk of pancreatitis (inform patients; discontinue if occurs). Thyroid adverse events (increased blood calcitonin, goitre, thyroid neoplasm) reported in particular in patients with pre-existing thyroid disease. C Not recommended: Insulin. Caution: Warfarin. A With metformin: Decreased appetite, headache, dizziness. With glimepiride: Nasopharyngitis, hypoglycaemia. With metformin and glimepiride: Bronchitis, hypoglycaemia, headache. With metformin and rosiglitazone: Nasopharyngitis, hypoglycaemia, headache, fatigue, pyrexia. All combinations: Anorexia, GI disorders.
6.5 THYROID HORMONES AND ANTITHYROID DRUGS
ELTROXIN
Goldshield
2MO Thyroid hormone. Levothyroxine (Na+) 25mcg, 50mcg, 100mcg. White scored tabs. 25mcg marked with FW 41 and others marked with tab. name and strength. 25mcg-28, A1.12; 50mcg-28, A1.52; 100mcg-28, A1.67. S Hypothyroidism, congenital hypothyroidism and juvenile myxoedema. P Initially 50-100mcg daily preferably before breakfast increasing by 50mcg at 3-4 week intervals to maintenance. Max. 100-200mcg daily. Cardiac disease: Initially, 25mcg daily or 50mcg on alternate days; may be increased by 25mcg at 4 week intervals. Over 50 years, initially 50mcg daily; adjust dosage according to clinical response rather than serum levels.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
173
6.6 PAGET’S
HORMONES
DISEASE
R As per over 50 years. 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. B Myocardial or adrenal insufficiency, diabetes mellitus, diabetes insipidus. Elderly. Pregnancy, lactation. Withdraw gradually. C Caution: Anticoagulants, antidiabetic agents, anticonvulsants, tricyclics, cholestyramine, cardiac glycosides, sympathomimetics, oral contraceptives. A Anginal pain, arrhythmias, tachycardia, headache, muscular weakness or cramps, restlessness, excitability, insomnia, flushing, sweats, GI disorders, weight loss.
NEO-MERCAZOLE
Amdipharm
2MO Antithyroid. Carbimazole 5mg, 20mg. Pink tabs. marked Neo and tab. strength one side, plain on reverse. 5mg-100, A5.88; 20mg-100, A21.85. S Thyrotoxicosis. P Initially, 20-60mg daily in 2 or 3 divided doses until patient is euthyroid. Maintenance, 515mg daily for 6-18 months. Alternatively, continue with 20-60mg daily and suppl.al thyroxine 50-150mcg daily for 6-18 months. Q Initially, 5-15mg daily in divided doses. D Tracheal obstruction. Lactation. B Pregnancy; See SPC. A Rashes, nausea, headache, arthralgia. Bone marrow depression-advise patients to report sore throats, mouth ulcers; discontinue drug.
6.6 PAGET’S DISEASE
ACLASTA
Novartis
2JN Bisphosphonate. Zoledronic acid anhydrous 5mg/ 100ml. Soln for inf. 100ml, A499.84. S Paget’s disease of the bone. P One IV inf. of 5mg in 100ml aqueous soln over at least 15 min, admin. via vented inf. line at constant inf. rate. Q Children and adolescents, not recommended. 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. 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.
ACTONEL
P & GP/sanofi aventis
2NT Biphosphonate. Risedronate (Na+) 30mg. White oval film-ctd tab. marked RSN and tab. strength. 28, A233.40. S Paget’s disease of the bone. P 30mg daily for 2 months. Swallow tab. whole in upright position, with glass of water, at least 30 mins. before 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.
174
single 40mcg dose. 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 AREDIA Novartis according to urinary osmolality. Avoid ingesting water while swimming. Discontinue during an 2N episode of vomiting and/or diarrhoea. Avoid fluid Bisphosphonate. Pamidronate disodium 15mg, overload. Severe bladder dysfunction and outlet 30mg. Powder in vials and solvent (WFI) in amps. obstruction. Pregnancy. A A 15mg-4, 137.36; 30mg-2, 137.36; 90mg-1, C Indomethacin, NSAIDs, substances A242.63. suspected to induce SIADH (e.g. TCAs, SSRIs, S Tumour-induced hypercalcaemia (TIH) chlorpromazine, carbamazepine). and tumour-induced osteolysis (TIO). Paget’s A Headache, stomach pain and nausea, disease of bone. fluid retention/hyponatraemia with accompanying P TIH: Total dosage is determined by symptoms (headache, nausea, vomiting, weight patient’s initial plasma Ca++ levels. Single IV inf. gain, decreased serum Na+ and in serious cases, of 30-60mg over 2-4 hours is adequate for mild convulsions). Nasal drops only: Nasal congestion/ hypercalcaemia. Severe hypercalcaemia requires rhinitis, epistaxis. 90mg. TIO: Initially single IV inf. of 30mg weekly adjusting after reassessment of the patient. Ferring Paget’s: 180mg IV inf., as 30mg once weekly for 6 DESMOSPRAY weeks or initial 30mg dose followed by 60mg 2MO every other week over 3 weeks. Max. 360mg, can Vasopressin analogue. Desmopressin acetate repeat every 6 months if required. Dilute before 100mcg/ml (10mcg/spray). Metered dose nasal use. Do not give as a bolus inj. spray. 6ml, A31.08. Q Not recommended. S Diagnosis and treatment of vasopressinB Pregnancy. Severe renal insufficiency. sensitive cranial diabetes insipidus. Possibility of precipitating convulsions due to V Diabetes insipidus treatment: 1-2 sprays electrolyte changes. once or twice daily according to requirements. C Infusion solutions containing Ca++, Diabetes insipidus diagnosis: 2 sprays. Limit fluid hypocalcaemic therapy, other bisphosphonates, intake to 0.5L from 1 hour before to 8 hours after plicamycin. admin. A Asymptomatic hypocalcaemia. Mild D Habitual or psychogenic polydipsia, transient pyrexia. Transient lymphocytopenia. alcohol abuse. Suspected cardiac insufficiency and Oliguria. other conditions requiring treatment with diuretic agents. Hyponatraemia. Syndrome of 6.7 PITUITARY DISORDERS inappropriate ADH secretion (SIADH). Moderate DDAVP DESMOPRESSIN Ferring and severe renal insufficiency. Hypertension, CVD. Patients over the age of 65. 2JN B Only use where orally admin. Vasopressin analogue. Desmopressin acetate 4mcg/ formulations are not feasible. Very young, elderly ml. Amp. 10 x 1ml, A134.12. patients, fluid and/or electrolyte imbalance, S Diagnosis and treatment of cranial patients at risk for increased intracranial pressure, diabetes insipidus. Renal function testing. reduced renal function, CVD, CF. Avoid ingesting P Diabetes insipidus treatment: 1-4mcg water while swimming. Discontinue during an IM, SC or IM once daily. episode of vomiting and/or diarrhoea. Avoid fluid Q Diabetes insipidus: doses from 0.4mcg overload. Severe hypanatraemia may occur. Severe may be used. V Diagnosis of diabetes insipidus: 2mcg SC bladder dysfunction and outlet obstruction. or IM. Renal function testing, single 2mcg dose SC Contains benzalkonium chloride (may cause bronchospasm). Pregnancy. or IM. Limit fluid intake to a max. of 0.5L from 1 C Indomethacin, NSAIDs, substances hour before until 8 hours after admin. suspected to induce SIADH (e.g. TCAs, SSRIs, 2MO chlorpromazine, carbamazepine). ALSO DDAVP DESMOPRESSIN NASAL DROPS, SOLUTION Desmopressin acetate100mcg/ml. Nasal A Headache, abdominal pain, nausea, nasal congestion/rhinitis, epistaxis. drops. 2.5ml dropper bottle, A10.85. Q Not recommended. 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.
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
GLYPRESSIN
Ferring
2N Vasopressin analogue. Terlipressin acetate 1mg. Powder and solvent for soln for inj. 5 vials,
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
GENITAL
A180.20.
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.
and nostrils. Do not use occlusive dressings. 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 2MO
2Y
ALDARA
Imidazole antifungal. Clotrimazole 500mg (pessary) plus 200mg (cream). White convex Meda pessary marked BAYER on one side and MU on
2MO Immunomodulator. Imiquimod 5%. Cream in single use sachets. Box of 12, A70.99. S External genital and perianal warts (condylomata acuminata). P Apply 3 times per week at bedtime until clearance of warts or for max. 16 weeks per episode of warts. Leave 6-10 hrs before removing by washing. Q Not recommended. D Urethral, intra-vaginal, cervical, rectal or intra-anal warts. B Caution: Autoimmune conditions, organ transplant patients. Uncircumcised men with foreskin associated warts; discontinue if local reactions occur. Avoid: Open wounds, eyes, lips
7.1
S Candidal and mixed candidal/ 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.
2MO ALSO CANESTEN DUOPAK Clotrimazole 100mg (pessary) plus 200mg (cream). White biconvex,
Ergha oblong pessaries marked Bayer on one side and
Triazole. Fluconazole 50mg, 150mg. Opaque caps; 50mg, light blue cap/ white body;150mg, light blue cap and body. 50mg-7, A12.56; 150mg-1, A5.31. 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 alkaline phosphatase, bilirubin, SGOTand SGPT. 0.1mg at bedtime increasing up to 0.2mg and subsequently 0.4mg by weekly dose escalations. CANAZOLE Pinewood Fluid restriction should be observed. D Habitual or psychogenic polydipsia. 2OY History of cardiac insufficiency, hyponatraemia, Imidazole antifungal. Clotrimazole 1%. Smooth conditions requiring treatment with diuretics. white cream. 20g, A4.48 (20g not GMS Moderate to severe renal insufficiency. Elderly, reimbursable); 50g, A4.00. older than 65 years. S Fungal skin infections due to candida, B Reduced renal function, CVD, cystic most commonly Candida albicans eg. vaginal fibrosis. Fluid and/or electrolyte imbalance. discharge and nappy rash. 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 twice daily for at least 1 month diarrhoea, vomiting. Avoid fluid overload. B Treat male partner to avoid recurrence Contains lactose. Pregnancy. of vaginal candidiasis. Cetostearyl alcohol (local C TCADs, SSRIs, chlorpromazine, skin reactions). Pregnancy (avoid, especially first carbamazepine, NSAIDs, loperamide. Food intake trimester). may reduce the intensity/duration of the C Latex contraceptives; use alternative antidiuretic effect at low doses. precautions for at least five days after. A Headache, stomach pain, nausea, vomiting, hyponatraemia, dizziness, dry mouth, CANESTEN COMBI Bayer HealthCare weight gain, in severe cases convulsions.
7.1 GENITAL INFECTIONS
INFECTIONS
reverse with vaginal applicator plus white cream. Combi (1 pessary, 10g cream), A9.36. S Pessary: Candidal vaginitis. Cream: Associated vulvitis and treatment of partner to prevent reinfection. P Pessary: Insert into vagina using applicator, preferably at night. Cream: Apply to vulva 2-3 times daily. For treatment of sexual partner: Apply to penis 2-3 times daily for 2 weeks. Q Not recommended.
2MO ALSO CANESTEN PESSARY Clotrimazole 100mg, 200mg, 500mg. Pessary with vaginal applicator. 100mg-6, A3.59; 200mg-3, A3.50; 500mg-1, A9.87. (trade price, non-GMS)
AD on reverse with vaginal applicator plus smooth, white, oil-in-water type cream. Duopak (6 pessaries, 20g cream), A5.05. S Pessaries: Candidal vaginitis. Cream: Associated vulvitis and treatment of partner to prevent reinfection. P Insert one pessary daily, preferably at night, for six consecutive days, or 2 pessaries for three consecutive days. Apply cream 2 or 3 times daily. Q Not recommended.
2OY ALSO CANESTEN CREAM Clotrimazole 1%, 2%. Cream. 1%-20g, A3.98 (20g not GMS reimbursable); 50g, A5.83. 2%-30g, A4.61. S Vulvitis, balanitis; treatment of partner to prevent reinfection. P Apply 2 or 3 times daily. V Not applicable.
2K ALSO CANESTEN THRUSH CREAM Clotrimazole 2%. 20g, A6.44. S Candidal vulvitis. P Apply 2-3 times daily. Q Not applicable. B Only on medical advice: More than 2 candidal infections in last 6 months, history of STDs, pregnancy, age under 16 or over 60 years. Abnormal vaginal bleeding/discharge, vulval or vaginal ulcers, dysuria. C May damage latex contraceptives (use alternative precautions for five days after treatment). A Local burning or irritation.
CANORAL
Bayer HealthCare
2MO Azole antifungal. Fluconazole 150mg. Opaque, light blue hard cap. (size 1) printed CAN 150. 1, A5.49. S Acute or recurrent genital candidiasis (candidal vaginitis, candidal balanitis). Consider treating partners of patients. P 1 cap. swallowed whole. Q Not recommended. D Pregnancy (use contraception), lactation. B May occur: Abnormalities in haematological, hepatic, renal and other biochemical function tests (particularly in AIDS and cancer patients); monitor for development of more serious hepatic injury. Exfoliative cutaneous reactions (e.g. Steven-Johnson syndrome, toxic epidermal necrolysis) may rarely occur. If rash develops, further fluconazole therapy not recommended. Anaphylaxis reported rarely. Contains lactose. C Contra: Terfenadine, cisapride. Caution: Coumarin anticoagulants, oral sulphonylureas, hydrochlorothiazide, midazolam, phenytoin , rifampicin, cyclosporin, theophylline, zidovudine, rufabutin, tacrolimus, astemizole or other drugs metabolised by cytochrome P450.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
175
7.1 GENITAL
UROLOGY
INFECTIONS
D Pregnancy. 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, leucopenia, neutropenia, agranulocytosis, CONDYLINE Nycomed thrombocytopenia, angioedema, face oedema, pruritus, urticaria. 2MO Cytotoxic. Podophyllotoxin 0.5%. Soln. 3.5ml (plus FAMCICLOVIR TEVA Teva applicators), A15.30. 2NO S Genital warts affecting the penis or female external genitalia. Antiviral. Famciclovir 125mg, 250mg. White to offP Apply twice daily for 3 days directly to white, round, film-ctd tabs marked 93 on one side the warts. Repeat if necessary at weekly intervals and 8117 or 8118 resp. on reverse. 125mg-10, (i.e. 4 days later) for max. 5 weeks. Max. 50 loops A19.01; 250mg-15, A 57.01. per application. S First episode and acute recurrent genital Q Not recommended. herpes infections. D Open wounds. Pregnancy, lactation. P First attack, 250mg three times daily for A Local irritation. 5 days. Recurrent attacks, 250mg twice daily for 5 days. Start during prodromal period or asap after DALACIN CREAM Pharmacia onset of lesion. Suppression, 250mg twice daily; interrupt at intervals of 6 to 12 months to observe 2N Antibacterial. Clindamycin (phosphate) 2%. Cream. possible changes in natural disease history. Q Not recommended. 40g + 7 applicators, A12.42. B Renal impairment (see SPC). S Bacterial vaginosis. P 1 applicator full intravaginally at night FAMVIR Novartis for 7 days. W People under 15 and over 60 years, not 2 N O recommended. Antiviral. Famciclovir 125mg, 250mg. White round D Lincomycin sensitivity. film-ctd tabs. marked FV on one side and strength B Discontinue use if persistent diarrhoea on reverse. 125mg-10, A21.11; 250mg-15, A63.34. or colitis appear. Renal or hepatic impairment. S First episode and acute recurrent genital C Neuromuscular blocking agents. herpes infections. A GI disturbances incl. pseudomembranous P First attack, 250mg three times daily for colitis. Jaundice and blood disorders. 5 days. Recurrent attacks, 125mg twice daily for 5 days. Start during prodromal period or asap after DIFLAZOLE Pinewood onset of lesion. Q Not recommended. 2MO B Renal impairment. Triazole. Fluconazole 50mg, 150mg, 200mg. Green-white, yellow and white capsules resp. FLAGYL sanofi-aventis 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, 2MO A51.60. S Genital candidiasis (acute or recurrent Nitromidazole. Antiprotozoal-antibacterial. vaginal candidiasis, candidal balanitis). Metronidazole 200mg, 400mg. Off-white film-ctd. 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, A1.66; 250, A19.65; 400mg-14, A2.35; 100, Q Under 16 years, not recommended A16.75. unless no alternative. D Pregnancy, lactation. 2MO B Discontinue if liver disease, rash ALSO FLAGYL-S ORAL SUSPENSION (superficial infection) or bullous lesions/erythema Metronidazole benzoate 200mg/5ml. 100ml, multiforme (systemic infection) occur. Exfolliative A6.17. cutaneous reactions, toxic epidermal necrolysis S Urogenital trichomoniasis. Non-specific (AIDS patients). vaginitis. C Terfenadine or cisapride P Trichomoniasis: 600mg daily in divided (contraindicated). Caution: Anticoagulants, doses for 7 days or 1g twice daily for 2 days or a benzodiazepines, sulphonylureas, HCTZ, single dose of 2g. Vaginitis: 400mg twice daily for phenytoin, rifampicin, ciclosporin, theophylline, 7 days or a single dose of 2g. zidovudine, rifabutin, tacrolimus, other substrates Q Trichomoniasis: Over 10 years, as per of cyt P450. adult. 7-10 years, 300mg daily in 3 divided doses. A Headache, rash, GI disorders. 3-7 years, 200mg daily in 2 divided doses. 1-3 years, 150mg daily in 3 divided doses. All for 7 DIFLUCAN Pfizer days. Vaginitis: Over 10 years, as per adult. 2MO D Active or chronic severe Peripheral and Triazole. Fluconazole 150mg. Blue cap. coded FLU Central Nervous System diseases. 150 and PFIZER. 1, A6.81. B Peripheral or central neuropathy. S Acute or recurrent vaginal candidiasis. Leucopenia. Transient epileptiform seizures. Candidal balanitis. Monitor during prolonged use. Hepatic P Single dose of 150mg orally. insufficiency or encephalopathy. Alcohol. Removed Q Do not exceed max. adult dose. during haemodialysis. Fructose intolerance. Elderly. A GI symptoms. Also reported: Dizziness, 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.
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Darkens urine. Pregnancy, lactation. 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.
FLUCOL
Rowex
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.
GYNO-DAKTARIN
Janssen-Cilag
2MO Imidazole antifungal-antibacterial. Miconazole nitrate 1200mg. Soft white vaginal cap. 1, A4.57. S Treatment of vulvo-vaginal candida infections in females incl. those with superinfection due to susceptible gram positive bacteria. P 1 cap. inserted high into the vagina before retiring at night as a single dose. Q Not recommended.
2MO ALSO GYNO-DAKTARIN CREAM Miconazole nitrate 2%. Vaginal cream. 78g with 16 applicators, A5.75. S Treatment of vulvovaginal candidosis and superinfection due to susceptible gram positive bacteria. P 2 applicators (10g) for 7 days or 1 applicator once daily before retiring for 14 days, applied deeply into vagina. Full course of treatments must be continued although sympomatic relief may occur. Q Not recommended.
2MO ALSO GYNO-DAKTARIN PESSARIES Miconazole nitrate 100mg. White pessary. 14, A4.39. S Local treatment of vulvovaginal candidosis infections and superinfections due to gram positive microorganisms. P 1 pessary inserted deep into vagina at night or 2 nightly for seven days. Repeat for 2 weeks even after symptoms disappear. Q Not recommended. D Hypersensitivity to imidzoles, incl. miconzole. B Absorption of antifungal may occur
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
UROLOGY
GENITAL
through denuded mucosa with possible toxicity. 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.
GYNO-PEVARYL ONCE
Janssen-Cilag
2MO 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.
IMUNOVIR
Newport Pharmaceuticals
2NO Immunomodulator. Inosine pranobex 500mg. White ovoid tab. 100, A42.68. S Management of patients with immunodepression suffering from viral infections incl. subacute sclerosing panencephalitis (SSPE), varicella and herpes simplex (type I and II). Genital warts, as adjunctive therapy to podophyllin or CO2 laser. P 50mg/kg of body weight up to a maximum of 4g (usually 2 tabs 3-4 times a day). SSPE: 100mg/kg of body weight up to a maximum of 3-4g continuously with regular monitoring. 3g daily in divided doses for 28 days. Q Under 1 year, not recommended; over 1 year, 50-100mg/kg body weight daily in four divided doses; over 12 years, as for adults. D Patients presently suffering from gout or elevated uric acid blood levels. B May be administered with caution in patients with a history of gout, hyperuricaemia, hepatic dysfunction, urolithiasis or in patients with impaired renal function. C Xanthine oxidase inhibitors, corticosteroids, uricosuric agents. A Elevated levels of uric acid.
METRONIDE
Clonmel
2MO Antiprotozoal-antibacterial. Metronidazole 200mg. White tab. scored and coded MZL 200 on one side, twin triangle logo on reverse and white tab. scored and coded MZL 400 on one side, twin triangle logo on reverse. 21, A1.62. S Trichomonal infestation in both sexes. P 600mg daily in divided doses or short two day course of 2g in divided doses or 2g as a single dose. Q Under 1 year, not recommended; 1-3 years, 50mg three times daily; 2-7 years, 100mg twice daily; 7-10 years, 100mg three times daily; 10-12 years, same as adult. B Short high dose treatment not recommended in pregnancy or lactation. Liver disease. C Alcohol, phenobarbitone, oral anticoagulants. Cimetidine, lithium.
INFECTIONS
7.1
A GI distress, furred tongue, unpleasant taste. Urticaria, angioedema, CNS disturbances, dark urine. Neuropathy, epileptiform seizures and leucopenia on long term therapy.
fluticasone and methylprednisolone, digoxin , cilostazol, disopyramide, carbamazepine, buspirone, alfentanil, alprazolam, brotizolam, midazolam IV, rifabutin , ebastine, repaglinide, fentanyl, reboxetine, halofantrine, loperamide. RELACTAGEL KoRa A Hypokalemia, headache, dizziness, nausea, GI disturbances, hepatitis, jaundice, 2K hyperbilirubinaemia, increased hepatic enzymes, Vaginal pH regulator. Lactic acid 4.5% w/w, glycogen 0.1% w/w. Soft colourless viscous gel. 7 x rash, pruritus, oedema. 5ml single dose applicator tubes, A7.29. VALHERP Ergha S Management of vaginal discharge 2NO through the regulation of vaginal pH. P Prevention: 1 single tube daily for 2-3 Antiviral. Herpes-specific enzyme inhibitor. days at bedtime after menstruation. Treatment: 1 Valaciclovir (HCl) 500mg. Creamy, oblong film-ctd single tube daily for 7 days at bedtime. tab. 10, A18.50; 30, A55.49; 42, A77.66. Q Not recommended. S Treatment and prevention (suppression) B Avoid when trying to conceive. of herpes simplex infections of skin and mucous A Stinging pain during fungal infections membranes, incl. initial and recurrent genital of the vagina or when there are tears in the herpes. vaginal tissue. P Treatment: 500mg twice daily. May be extended to 10 days for initial episodes. For SPORANOX Janssen-Cilag recurrent episodes, treatment should be for 5 days. Begin treatment as early as possible; ideally 2MO during the prodromal period or immediately after Azole antifungal. Itraconazole 100mg. blue/ 1st signs or symptoms appear for recurrent transparent cap. and pink body, size 0. 15, episodes. Suppression of recurrences : In A26.04. immunocompetent patients, 500mg once daily. For S Onychomycosis, systemic mycoses, immunocompromised HIV infected patients, pityriasis versicolor, dermatophytoses, oral 500mg twice daily. Renal impairment: See SPC. candidosis. vulvovaginal candidosis. B Caution: Renal impairment, elderly, P Onychomycosis, 200mg once daily for 3 hepatic impairment and liver transplantation (high months or 2 pulse treatments for fingernail doses). Ensure adequate fluid intake in patients at infections or 3 pulse treatments for toenail risk of dehydration (particularly the elderly). Use infections. A pulse treatment consists of 2 caps. in genital herpes: Safer sex practices also (200mg) twice daily for 7 days. Pulse treatments recommended. Pregnancy, lactation. Contains are separated by a 3-week drug-free interval. lactose. Pityriasis versicolor, 200mg once daily for 7 days. C Caution at high valaciclovir doses (8g/ Tinea corporis, tinea cruris, 100mg once daily for 2 day): Ciclosporin, tacrolimus, mycophenolate weeks. Tinea pedis, tinea manuum, 100mg once mofetil. daily for 4 weeks. Fungal keratitis, 200mg once A Nausea, headache. daily for 3 weeks. Oral candidosis, 100mg once daily for 2 weeks. Vulvovaginal candidosis 200mg VALOTIX Rowex twice daily for 1 day or 200mg once daily for 3 2NO days. Antiviral. Herpes-specific enzyme inhibitor. W Not recommended. Valaciclovir (HCl) 500mg. White to off-white cap.D Pregnancy-contraception must be used shaped film-ctd tab. with 500 debossed on one during, and for one menstrual cycle after side. 10, A19.14. treatment. Lactation. S Treatment of initial and recurrent B CHF or history of: Use only if benefit outweighs risks. CHF risk increases with total daily genital Herpes simplex infections. P 500mg twice daily for 10 days for the dose. Transient LV ejection fraction may occur. initial episode; 1g per day in 1 or 2 divided doses Caution: Hepatic, renal impairment. Monitor liver for 5 days for recurrent episodes. Initiate asap, function, patient should report signs of hepatitis; preferably at prodromal stage or when lesions if occurs stop immediately. Discontinue if appear. Renal impairment: See SPC. neuropathy occurs. Oral solution not recommended for severe neutropenia. Transient or B Caution: History of renal impairment, elderly, hepatic impairment, liver transplantation. permanent hearing loss may occur. Not Maintain adequate hydration. Use in genital recommended: Fructose intolerance, glucoseherpes: Safer sex practices also recommended. galactose malabsorption, sucrase-isomaltase Pregnancy, lactation (consider topical treatment). insufficiency. C Caution if impaired renal function C Contraindicated: Astemizole, bepridil, (regular monitoring recommended): cisapride, dofetilide, levacetylmethadol Immunosuppressants, aminoglycosides, (levomethadyl), mizolastine, pimozide, quinidine, organoplatins, iodinated contrast media, sertindole, terfenadine, CYP3A4 metabolized methotrexate, pentamidine, foscarnet. Caution at HMG-CoA reductase inhibitors (e.g. atorvastatin, lovastatin, simvastatin), triazolam, oral midazolam, high valaciclovir doses (8g/day): Cimetidine, probenecid, mycophenolate mofetil. ergot alkaloids (e.g. dihydroergotamine, A Headache, nausea. 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,
VALTREX
GSK
2NO Antiviral. Herpes-specific enzyme inhibitor. Valaciclovir (HCl) 500mg. White tab. marked GXCF1. Herpes simplex treatment pack-10, A25.52. Herpes simplex suppression pack-30, A76.54.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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7.2 URINARY
UROLOGY
TRACT INFECTIONS
S Treatment of Herpes simplex infections 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. Q Not applicable. B Caution: Severe renal impairment, elderly, liver disease. Maintain adequate hydration. Use in genital herpes: Safer sex practices also recommended. Pregnancy, lactation. A Mild headache. Nausea.
D Pregnancy, lactation. Cardiac disease, 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.
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.
CYSTOPURIN
2MO
Roche Consumer
MACRODANTIN
Goldshield
Nitrofuran. Macrocrystaline nitrofurantoin 50mg, 100mg. Yellow/white cap and yellow cap. both Alkalising agent. K+ citrate 3g. Powder. Sachet-6 x marked with name and strength. 50mg-30, A3.63; A 3g, 4.66. 100mg-30, A6.23. WARTICON Stiefel S Symptomatic management of mild S Urinary tract infections spontaneous or 2MO lower urinary tract infection. after surgery or instrumentation. P Dose should be taken with food or Cytotoxic. Podophyllotoxin 0.15%. Cream. 5g (plus P Each sachet should be disolved in at least 200ml cold water. One sachet 3 times daily milk. Acute UTI, 50mg four times dailly for 7 days. mirror), A22.15. for 2 days. Severe recurrent UTI, 100mg four times daily for 7 S Genital warts affecting external Q Under 6 years, not recommended; over days. Long term suppression, 50-100mg once daily genitalia. 6 years, same as adults. at bedtime. Prophylaxis, 50mg four times daily P Apply twice daily for 3 days. If warts D Patients with hyperaloemica or renal during procedure and 3 days after. persist, 3 day treatment may be repeated weekly insufficiency. Q Under 3 months, not recommended; 3 for up to 4 weeks in total. B Renal dysfunction, cardiac disease, GI months-10 years: Acute UTI, 3mg/kg daily in four Q Not recommended. inflammation. divided doses for 7 days. Suppressive therapy, D Open wounds. Pregnancy, lactation. 1mg/kg once daily. Over 10 years, same as adult. A Local irritation. FURADANTIN Goldshield D Anuria, oliguria. renal impairment. ZOVIRAX GSK 2 M O Pregnant patients at term. B Monitor pulmonary, neurological and 2NO Nitrofuran. Nitrofurantoin 50mg, 100mg. Yellow hepatic function during long term therapy and in pentagonal scored tabs. marked with tab. Antiviral. Aciclovir 200mg. White, round film-ctd the elderly. Anaemia, diabetes, electrolyte strength. 50mg-100, A11.33; 100mg-100, A19.10. tab. marked GXCF3 on one side. 25, A33.56. imbalance, vit. B deficiency, debilitation. Lactation. S Urinary tract infections spontaneous or 2NO C Magnesium trisilate, probenecid, ALSO ZOVIRAX SUSPENSION Aciclovir 200mg/5ml. after surgery or instrumentation. sulphinpyrazone, quinolones. P Acute UTI, 50mg four times daily for 7 125ml, A33.33. A Withdraw if symptoms of pulmonary S Treatment and longterm suppression of days. Severe recurrent UTI, 100mg four times daily for 7 days.Long term suppression, 50-100mg once reactions, hepatitis, haemolysis or peripheral genital herpes. Prophylaxis of genital herpes in neuropathy occur. GI upset, anorexia, allergic daily at bedtime. Prophylaxys, 50mg four times immunocompromised patients. reactions, blood dyscrasias. daily during procedure and 3 days after. P Treatment-200mg five times daily at Q Under 3 months, not recommended; 3 four hourly intervals for 5 days. Prophylaxis and 7.3 RENAL AND BLADDER DISORDERS months-10 years: Acute UTI, 3mg/kg daily in 4 suppression-200mg four times daily at six hourly divided doses for 7 days with food or milk. intervals. See SPC. ALFU Rowex Suppressive therapy, 1mg/kg once daily. Over 10 Q Treatment: Under 2 years, 2.5ml five 2MO years, same as adult. times daily at four hourly intervals for 5 days. D Anuria, oliguria, renal impairment. Selective a1-blocker. Alfuzosin (HCl) 10mg. White, Over 2 years, same as adult. Prophylaxis: Under 2 round, bevelled-edge, prolonged release tab. years, 2.5ml four times daily at six hourly intervals. Pregnant patients at term. B Monitor pulmonary, neurological and 10mg-30, A21.29. Over 2 years, as adult. hepatic function during long term therapy and in S Moderate to severe functional 2NO the elderly. Anaemia, diabetes, electrolyte symptoms of BPH. ALSO ZOVIRAX CREAM Aciclovir 5%. (GMS)2g, imbalance, vit. B deficiency, debilitation. Lactation. P 10mg daily immediately after the same A3.56; 10g, A17.84; 2g, A3.56; Pump pack 2g, C Magnesium trisilate, probenecid, meal each day. Tab. should be swallowed whole A4.89. with fluid. V Apply 5 times daily at 4 hourly intervals sulphinpyrazone, quinolones. A Withdraw if symptoms of pulmonary Q Not applicable. for 5 days. reactions, hepatitis, haemolysis or peripheral D Conditions with orthostatic hypotension. B Severe renal impairments. neuropathy occur. GI upset, anorexia, allergic Hepatic insufficiency. C Probenecid reactions, blood dyscrasias. B Severe renal impairment (not A Transient irritation, mild drying and recommended). Transient postural hypotension flaking of skin during topical use. MACROBID Goldshield may develop. Caution: Hypersensitivity to other a17.2 URINARY TRACT INFECTIONS blockers, patients who developed pronounced 2MO hypotension with other a1-blockers; acute cardiac Nitrofuran. Nitrofurantoin (as macrocrystals and CYMALON Actavis failure. If angina pectoris recurs/worsens, monohydrate) 100mg. Blue/yellow modifieddiscontinue. Contains lactose. 2 release cap. marked Eaton BID. 14, A4.53. C Contra: Other a1-blockers. Caution: Alkalising agent. Sodium citrate 2.8g, citric acid S Urinary tract infections, pyelitis, Antihypertensives, nitrates, potent CYP3A4 (anhydrous) 1g, Na+ bicarbonate 1.2g, sodium prophylaxis in genito-urinary surgery, long term inhibitors. Anaesthetics (withdraw tab. 24 hrs carbonate 0.1g with a combined alkalinity suppressive therapy. previously). equivalent to 4.4g sodium citrate with added P 1 twice daily with food or milk for 7 sucrose and saccharin. Granules. Sachets-6, A4.50. days. Prophylaxis, 1 twice daily for 4 days, starting A Dizziness, headache, vertigo, malaise, postural hypotension, GI disorders, asthenia. on day of procedure. Long term suppression, 1 S Relief of symptoms due to cystitis in daily at bedtime. adult females only. ARANESP Amgen Q Under 12 years not applicable. P One sachet in water 3 times daily for 2 5NT D Anuria, oliguria, renal impairment. days. Human erythropoietin. Darbepoetin alfa 10, 15, Pregnant patients at term. Q Not recommended.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
UROLOGY
RENAL
AND BLADDER DISORDERS
7.3
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 5NT concurrently. With renal impairment, collagen ALSO ARANESP SURECLICK Darbepoetin alfa 20, vascular disease, immunosuppressant therapy or 40, 60, 80, 100, 150, 300 and 500mcg. Soln. for inj. leukopenic drugs, monitor white cell count and in pre-filled pen. 20mcg/0.5ml x1, A48.53; 40mcg/ BYTRITE Helsinn Birex urinary protein. Contains lactose. 0.4ml x1, A97.06; 60mcg/0.3ml x1, A145.59; C K+sparing diuretics or K+suppl., NSAIDs, A 80mcg/0.4ml x1, 194.12; 100mcg/0.5ml x1, 2MO vasodilators, clonidine, allopurinol, procainamide, A242.65; 150mcg/0.3ml x1, A363.98; 300mcg/0.6ml ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, probenecid, immunosuppressants. x1, A727.95; 500mcg/1ml x1, A1091.93. 10mg. Opaque hard gelatin caps. Yellow, light A Rash, loss of taste, cough. Rarely S Anaemia associated with chronic renal orange, pink and blue cap with white bodies neutropenia, agranulocytosis, proteinuria. failure in adults and paediatric patients. printed 93 and 7209, 7210, 7211, 7212 resp. P Correction phase: Initially 0.45mcg/kg by 1.25mg-28, A4.14; 2.5mg-28, A5.89; 5mg-28, CARDURA Pfizer SC or IV inj. once weekly, or 0.75mcg/kg SC once A8.23; 10mg-28, A11.22. every 2 weeks if patient not on dialysis. Adjust 2MO S Non-diabetic/diabetic overt and dose as necessary, increase by approx. 25% if Hb incipient nephropathy. Prevention of progression Selective a-blocker. Doxazosin mesylate (equiv. increase is Q1g/dL in 4 weeks or decrease by 25of microalbuminuria to overt nephropathy. doxazosin) 1mg, 2mg. White round and oblong 50%, if rise in Hb is q2.5g/dL in 4 weeks. If Hb P Nephropathy: Initially, 1.25mg once biconvex tabs. marked CN1 and CN2 resp. with q14g/dL, discontinue until Q13g/dL then restart daily. If tolerated, should be doubled at intervals Pfizer logo on reverse. 2mg tab. scored. 1mg-28 at approx. 25% below previous dose. Maintenance: of 2-3 weeks. Max. 5mg daily. Microalbuminuria (Cal/Pk), A8.21; 2mg-28, A10.95. Not on dialysis, once monthly dose equal to twice to overt nephropathy: Initially 2.5mg once daily. If S Adjunct in treatment of urinary outflow previous once every 2 week dose by SC; dialysis tolerated, double after 1 week and after another obstruction and symptoms associated with BPH. patients, if switching from once weekly to once 3 weeks up to 10mg. Usual maintenance: 10mg P Initially 1mg once daily; may be every other week should initially receive dose daily. Discontinue diuretic 2-3 days prior to increased to 2mg, then 4mg, up to max. 8mg equivalent to twice the previous once weekly therapy; if not possible, reduce diuretic dose. daily. Titration interval, 1-2 weeks. Usual dose. Patients receiving r-HuEPO 1, 2 or 3 times Q Not recommended. recommended dose, 2-4mg once daily. weekly may switch to once weekly or once every D History of angioneurotic oedema Q Under 12 years, not recommended. other week. If switching from r-HuEPO, calculate relating to previous ACE inhibitor treatment. D Lactation. initial weekly dose (mcg) by dividing total weekly Pregnancy, lactation. Use in children. B Pregnancy. Renal/hepatic impairment, dose of r-HuEPO by 200. Determine initial every B Aortic stenosis, outflow obstruction (not LV failure, elderly. Driving/using machines. Postural other week dose by dividing the total cumulative recommended). Assess renal function prior to and hypotension (warn patients), cataract surgery. dose of r-HuEPO admin. over a 2 week period by during treatment. Impaired renal/liver function; Contain lactose. 200. See SPC. reduce dose and monitor closely. Haemodialysis C Caution: PDE-5 inhibitors. Q Correction phase, no guidance for using high-flux membranes (avoid). Correct A Vertigo, nausea, asthenia, oedema, patients aged 1-10 years. Over 11 years; Correction volume/salt depletion before initiating therapy. fatigue, malaise, dizziness, headache, postural phase as per adults. Maintenance; over 11 years as Collagen vascular disease; monitor white blood dizziness, somnolence, syncope, rhinitis. per adults. Paediatric patients 1-18 years receiving cell counts and protein levels in urine. r-HuEPO 2-3 times a week can convert to once Hyperkalaemia, angioneurotic oedema have been CARSEM XL Teva weekly Aranesp. Those receiving r-HuEPO once reported rarely. Surgery/anaesthesia. Driving or 2MO weekly can convert to Aranesp once every other operating machines. Selective a-blocker. Doxazosin (as mesilate), 4mg. week. The initial weekly or once every other week C Caution: Antidiabetics, NSAIDs. White, round biconvex film-ctd prolonged-release dose (mcg/kg) can be determined by dividing the A Nausea, dizziness and headache, GI tab. with DL bossing on one side. 28, A12.82. total weekly dose of r-HuEPO (IU/week) by 240. disturbances, cough, skin/mucosal reactions. S Symptomatic treatment of BPH. D Poorly controlled hypertension. Patients suspected or confirmed to have neutralising CALCIUM RESONIUM Sanofi P 4mg once daily. May be increased to 8 mg once daily. antibodies to erythropoietin. Lactation. 2O Q Not recommended. B Evaluate iron status prior and during Ion-exchange resin. Ca++ polystyrene sulphonate. treatment. Iron suppl. may be required. Monitor D Benign hyperplasia and concomitant Flavoured powder. 300g, A51.82. BP. Ischaemic heart disease, CHF, sickle cell congestion of upper urinary tract, chronic UTIs, S Hyperkalaemia associated with anuria or anaemia, epilepsy. Liver disease (no data). Monitor bladder stones. Overflow bladder, anuria, severe oliguria. Hyperkalaemia in patients + K levels. PCRA (discontinue if occurs). Pregnancy. progressive renal impairment. History of requiring acute dialysis and in patients on regular oesophageal or GI obstruction, decreased GI tract C Caution: Cyclosporin, tacrolimus. haemodialysis or on prolonged peritoneal dialysis. lumen diameter. Lactation. Pregnancy (unless A Headache, hypertension, thrombosis of P Usually 15g three or four times daily; vascular access, inj. site pain. clearly needed). see SPC. B Severe hepatic impairment, not AVODART GSK Q 1g/kg daily in divided doses; recommended. Monitor for postural effects when maintenance, 0.5g/kg daily. initiating therapy; caution in hypotensive patients 2NO D Hyperparathyroidism, multiple myeloma, or patients with known orthostatic dysregulation. Testosterone-5-a-reductase inhibitor. Dutasteride sarcoidosis. Caution: Acute heart disease, mild-moderate 0.5mg. Opaque, yellow, oblong soft gelatin cap. B Monitor serum K+ and Ca++. hepatic impairment, Diabetic Autonomic marked GX CE2. 30, A29.69. A Hypercalcaemia. Neuropathy, cataract surgery. May influence S Moderate to severe symptoms of BPH. plasma renin activity and urinary excretion of Reduction in risk of acute urinary retention and CAPOTEN BMS vanillylmandelic acid. Driving/operating machinery. surgery in patients with moderate to severe 2MO C Not recommended: Tadalafil. Caution: symptoms of BPH. ACE inhibitor. Captopril 12.5mg, 25mg, 50mg. Sildenafil, vardenafil, other antihypertensives, nonP Use alone (1 once a day, swallowed Mottled white cap. shaped scored tab. marked steroidal antirheumatics, estrogens, whole) or in combination with 0.4mg tamsulosin. SQUIBB 450, mottled white quarter scored square sympathomimetics, medicinal products which may Response can take up to 6 months. Q Contraindicated. tab. coded 452 and SQUIBB, mottled white oval influence hepatic metabolism (e.g. cimetidine). 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.
D Women, children and adolescents. Severe hepatic impairment. B Mild to moderate hepatic impairment; caution. Perform evaluations for prostate cancer (eg. digital rectal examination) before therapy and periodically thereafter. PSA levels decreased by 50% after 6 months (double values for comparison with normal ranges in untreated men). C Caution: Potent CYP3A4 inhibitors, verapamil or diltiazem. A Impotence, decreased libido, ejaculation disorders, gynecomastia.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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P Diabetes insipidus: Dose range, 120mcg720mcg daily. Initially 60mcg sublingually three times daily. Usual maintenance dose, 60mcg120mcg sublingually three times daily. Primary nocturnal enuresis: Initially, 120mcg sublingually at bedtime; may be increased up to 240mcg. 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 A A resp. 3mg-100, 19.01; 5mg-100, 33.78. 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 Reduced renal function, CVD, cystic B Thyrotoxicosis, cardiac insufficiency, fibrosis, severe bladder dysfunction, outlet cardiac surgery, GIT pathology, neurological disorders. obstruction. Signs of water retention/ C Anticholinergics. hyponatraemia (interrupt treatment). Nocturnal enuresis or nocturia: Limit fluid intake to min. DESMOSPRAY Ferring from 1 hr before until 8 hrs after admin; discontinue if diarrhoea, vomiting until fluid 2MO balance normal. Systemic infections, fever, Vasopressin analogue. Desmopressin acetate gastroenteritis (interrupt treatment). Pregnancy. 100mcg/ml (10mcg/spray). Metered dose nasal C Caution: TCAs, SSRIs, chlorpromazine, spray. 6ml, A31.08. carbamazepine, NSAIDs, loperamide. S Nocturia associated with multiple A Headache, stomach pain, nausea, sclerosis. Renal function testing. P Nocturia: 1 or 2 sprays at bedtime max. hyponatraemia, dizziness, dry mouth. Long-term 1 dose in 24 hours. Renal function testing: 2 sprays treament: Peripheral oedema, micturition frequency, weight increase. in each nostril. Q Renal function testing, up to 1 year, 1 DETRUNORM XL Ferring spray; 1-15 years, 1 spray in each nostril. D Habitual or psychogenic polydipsia, 2MO alcohol abuse. Suspected cardiac insufficiency and Spasmolytic/anticholinergic. Propiverine HCI other conditions requiring treatment with diuretic (equivalent to 27.28mg propiverine) 30mg. Orange agents. Hyponatraemia. Syndrome of and white modified-release hard cap., containing inappropriate ADH secretion (SIADH). Moderate white pellets. 28, A34.94. and severe renal insufficiency. Hypertension, CVD. S Urinary incontinence and/or increased Patients over the age of 65. urinary frequency and urgency as may occur in B Only use where orally admin. patients with overactive bladder. formulations are not feasible. Very young, elderly P One cap. once a day, swallowed whole. patients, fluid and/or electrolyte imbalance, Q Not recommended. patients at risk for increased intracranial pressure, D Obstruction of the bowel. Significant reduced renal function, CVD, CF. Avoid ingesting degree of bladder outflow obstruction where water while swimming. Discontinue during an urinary retention may be anticipated. Myasthenia episode of vomiting and/or diarrhoea. Avoid fluid gravis, intestinal atony, severe UC, toxic overload. Severe hypanatraemia may occur. Severe megacolon, uncontrolled angle closure glaucoma, bladder dysfunction and outlet obstruction. moderate or severe hepatic impairment, Contains benzalkonium chloride (may cause tachyarrhythmias. Pregnancy, lactation. bronchospasm). Pregnancy. B Caution: Autonomic neuropathy, severe C Indomethacin, NSAIDs, substances renal impairment, moderate or severe hepatic suspected to induce SIADH (e.g. TCAs, SSRIs, impairment. May aggravate severe CHF, prostatic chlorpromazine, carbamazepine). hypertrophy, hiatus hernia with reflux A Headache, abdominal pain, nausea, oesophagitis, cardiac arrhythmia, tachycardia. nasal congestion/rhinitis, epistaxis. Induces mydriasis. May induce or precipitate acute angle-closure glaucoma. Exclude pollakiuria and DESMOTABS MELT Ferring nocturia due to renal disease or CHF as well as 2MO organic bladder diseases before treatment. Vasopressin analogue. Desmopressin (free base) Contains lactose. 120mcg (as desmopressin acetate). White, round, C TCAs, tranquillisers, systemic oral lyophilisate marked with two drop shaped anticholinergics, amantadine, neuroleptics and bfigures. 30, A39.13. adrenoceptor agonists, cholinergics, isoniazid. S Diagnosis/treatment of cranial diabetes Possibly metoclopramide, other CYP3A4 substrates insipidus incl. post-hypophysectomy polyuria/ and CYP3A4 inhibitors. polydipsia and treatment of primary nocturnal A Dry mouth, accommodation abnormal, enuresis in patients with normal ability to accommodation disturbances, vision abnormal, concentrate urine. Nocturia in adults, associated fatigue, headache, abdominal pain, dyspepsia, with nocturnal polyuria. constipation. A Apathia, muscle cramps, fatigue, malaise, headache, somnolence, accomodation disturbances, palpitations, chest pain, giddiness, dizziness, oedema, orthostatic dysregulation, dyspnoea, rhinitis, GI disorders, frequent desire to micturate, increased micturation, delayed ejaculation, asthenia.
180
DETRUSITOL
Pfizer
2MO Anticholinergic. Tolterodine tartrate 1mg, 2mg White film-ctd tabs. marked TO or DT. 1mg-56, A35.97. 2mg-56, A39.98. S Treatment of unstable bladder with symptoms of urgency, frequency or urge incontinence. P 2mg twice daily. Impaired liver function/ severely impaired renal function: 1mg twice daily. If troublesome side effects occur dose may be reduced from 2mg to 1mg twice daily. Re-evaluate after 2-3 months. Q Not recommended.
2MO ALSO DETRUSITOL SR Tolterodine tartrate 2mg, 4mg. Blue/green cap. and blue cap. resp. Both prolonged release caps. marked with symbol and 2 or 4 in white. 2mg-28, A38.32; 4mg-28, A39.97. P 4mg once daily. Impaired liver/severely 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, abnormal vision, vertigo, palpitations, GI disorders, dry skin, dysuria, urinary retention, fatigue, headache, chest pain, peripheral oedema. Detrusitol only: Bronchitis, paresthesia, increased weight. Detrusitol SR only: Sinusitis.
DITROPAN
Sanofi
2MO Antispasmodic-anticholinergic. Oxybutynin (HCl) 2.5mg, 5mg. Pale blue oval tab., pale blue tab. Both marked DITROPAN one side, scored and marked S&N 2.5 or S&N 5 on reverse resp. 2.5mg84, A14.15; 5mg-84, A27.76.
2MO ALSO DITROPAN ELIXIR Oxybutynin (HCl) 2.5mg/ 5ml. 150ml, A6.35. S Urinary incontinence, frequency and urgency in patients with an unstable bladder. Neurogenic bladder disorders causing detrusor hyper-reflexia in conditions such as multiple sclerosis and spina bifida. Children over 5 years, neurogenic bladder disorders and voiding symptoms due to detrusor instability. Noctural enuresis. Vesicoureteric reflux. P 5mg two or three times daily, adjusting according to response. Max. 5mg four times daily. R Frail patients, max. 10mg daily in divided doses. Q Over 5 years, 10mg daily in divided doses. Under 5 years, not recommended. D Bowel obstruction, significant bladder outflow obstruction. Intestinal atony, severe ulcerative colitis or toxic megacolon, myasthenia gravis, glaucoma. Hyperpyrexia and hiatus hernia. B Autonomic neuropathy, hepatic or renal disease. Pregnancy, lactation. Alertness may be impaired. C Anticholinergics, phenothiazines,
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
AND BLADDER DISORDERS
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 DORALESE Chemidex patients on peritoneal dialysis. Treatment of severe anaemia of renal origin accompanied by 2MO clinical symptoms in adult patients with renal Selective a1 blocker. Indoramin 20mg. Yellow triangular film-ctd ’Tiltab’ tab. 60 (4 x 15), A9.97. insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of S Urinary obstruction due to benign transfusion requirements in adult patients prostatic hypertrophy particularly in patients in receiving chemotherapy for solid tumours, whom surgery is contraindicated or delayed. malignant lymphoma or multiple myeloma, and at P 1 twice daily, increasing by 1 daily at fortnightly intervals; max. 5 daily in divided doses. risk of transfusion as assessed by the patient’s general status (e.g. cardiovascular status, preR 1 at night. existing anaemias at the start of chemotherapy). Q Not applicable. To increase yield of autologous blood. To reduce D Cardiac failure. exposure to allogeneic blood transfusions prior to B If drowsiness occurs, avoid driving or operating machinery and CNS depressants. Hepatic major elective orthopaedic surgery with high risk or renal insufficiency, Parkinson’s disease, epilepsy of transfusion complications. P Haemodialysis: Initially 50 IU/kg three or history of seizures. History of depression. Control incipient cardiac failure before treatment. times per week by IV inj. following dialysis. C MAOIs, antihypertensives (incl. thiazide Increase if necessary by 25 IU/kg three times per week every 4 weeks to achieve a Hb 10-12g/dL. diuretics, b-blockers, vasodilators). Combination Maintenance, recommended total weekly dose, with other protein-bound drugs. 75-300 IU/kg. Peritoneal dialysis: 50 IU/kg twice A Initially drowsiness or sedation. Less weekly by IV inj. Increase if necessary by 25 IU/kg commonly dry mouth, nasal congestion, weight gain, dizziness, retrograde ejaculation, depression, twice weekly every 4 weeks to achieve a Hb 1012g/dL. Maintenance, 25-50 IU/kg per week in two sleep disturbances, vivid dreams. equal doses. Non-dialysis: Initially 50 IU/kg 3 times DOXANE XL Rowex per week by IV inj. Increase if necessary by 25 IU/ kg 3 times/week every 4 weeks to achieve a Hb 2MO 10-12g/dL. Maintenance 17-33 IU/kg/week in 3 Selective a-blocker. Doxazosin (as mesilate) 4mg. divided doses; max. 200 IU/kg 3 times/week. May Prolonged release tab. White, round, biconvex admin. by SC inj. where IV not readily available. tab. embossed DL. 28, A12.66. Chemotherapy, autologous predonation and major S Symptomatic treatment of BPH. elective orthopaedic surgery: See SPC. P 4mg once daily. May be increased to Q Haemodialysis: Initially 50 IU/kg 3 times 8mg once daily if necessary. per week by IV inj. following dialysis. Increase if Q Not recommended. necessary by 25 IU/kg 3 times per week every 4 D Benign hyperplasia and concomitant weeks to achieve a Hb 9.5-11g/dL. Maintenance, congestion of the upper urinary tract, chronic UTIs under 10kg, 75-150 IU/kg; 10-30kg, 60-150 IU/kg; or bladder stones. Overflow bladder, anuria or over 30kg, 30-100 IU/kg. All 3 times per week. progressive renal insufficiency. History of D Uncontrolled hypertension. Severe oesophageal or GI obstruction or decreased lumen coronary, peripheral arterial, carotid or cerebral diameter of the GI tract or patients at increased vascular disease in patients scheduled for major risk for such obstruction. Pregnancy (only if elective orthopaedic surgery and not participating benefit outweighs risk), lactation. in autologous blood donation. Patients unable to B Not considered appropriate as first line receive antithrombotic prophylaxis. Patients who treatment in hypertension. Monitor on initiation have developed Pure Red Cell Aplasia (PRCA) (risk of postural effects). Caution: Acute heart following erythropoietin treatment. disease; minor/moderate hepatic impairment, B Caution: Hypertension, ischaemic diabetic autonomic neuropathy. Severe hepatic vascular disease, thrombocytosis, history of impairment, not recommended. Driving/ using epilepsy, liver failure, increased risk of thrombotic machines. vascular events in cancer patients, porphyria. C Caution: NSAIDs, oestrogens, Correct other causes of anaemia; iron suppl. may sympathomimetics, PDE-5 inhibitors. be required. Monitor BP, Hb, blood count, serum A Apathia, muscle cramps, fatigue, electrolytes. Limit Hb rise to Q2g/dL per month. malaise, headache, somnolence, accommodation Chronic renal failure patients treated by SC route: disturbances, palpitations, chest pain, giddiness, Monitor regularly for loss of efficacy. Theoretically dizziness, oedema, orthostatic dysregulation, could stimulate malignant growth. Pregnancy, dyspnoea, rhinitis, constipation, dyspepsia, lactation. increased micturation (or desire to), delayed C Cyclosporin. ejaculation, asthenia. A Hypertension, headache, deep vein thrombosis, pulmonary embolism, flu-like EPREX Janssen-Cilag symptoms, seizures, rash, palpebral oedema, diarrhoea, vomiting, arthralgia, pyrexia, shunt 5NT thromboses. Rarely, PRCA, withdraw and do not Erythropoietin. Epoetin alfa. Range of 1-6 thousand IU, 8000 IU, 10000 IU as well as 40000 IU transfer to other erythropoietins. human recombinant erythropoietin. (r-HuEPO). FASTURTEC Sanofi Soln. in pre-filled syringe. 1000 IU/0.5ml-6x0.5ml, 2JN A72.79; 2000 IU/0.5ml-6x0.5ml, A145.59; 3000 IU/ 0.3ml-6x0.3ml, A218.38; 4000 IU/0.4ml-6x0.4ml, Uricolytic agent. Rasburicase 1.5mg/ml. Powder A291.18; 5000 IU/0.5ml-6x0.5ml, A363.97; 6000 IU/ and solvent for soln. for inf. 1.5mg/ml-3, A228.71. amantadine, haloperidol, L-dopa, digitalis, tricyclic antidepressants. A Dry mouth, blurred vision, facial flushing, weakness, drowsiness, dizziness, nausea, constipation, tachycardia, palpitations.
7.3
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.
FINASTERIDE RANBAXY
Ranbaxy
2NO Selective 5 a reductase inhibitor. Finasteride 5mg. White, round, biconvex, film-ctd tab., diameter 7mm, embossed F and 5 on one side. 28, A17.88. S Treatment and control of BPH to cause regression of the enlarged prostate, improve urinary flow and improve symptoms associated with BPH; to reduce incidence of acute urinary retention and need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Only for patients with an enlarged prostate (prostate volume q 40ml). P 5mg tablet daily, swallowed whole and not divided or crushed. Treatment for at least 6 months may be necessary. D Women or children. B Caution: Impaired hepatic function. Carefully monitor patients for obstructive uropathy (patients with large residual urine volume and/or severely diminished urinary flow). Exclude obstruction due to trilobular growth pattern of the prostate before initiating. Exclude prostate cancer by digital rectal examination and, if necessary, determination of PSA, prior to and during therapy. Women who are pregnant or may become pregnant should not handle crushed or broken tablets. Contains lactose. 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
181
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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 patients at risk of obstructive uropathy. Impaired hepatic function. Pregnant women should not handle crushed or broken tablets. Contains lactose. A Impotence, reduced libido, reduced volume of ejaculate, breast tenderness/breast enlargement.
FINTEX
Helsinn Birex
2NO Selective 5-a reductase inhibitor. Finasteride 5mg. Blue, 7mm, round biconvex, film-ctd tab. marked F5 on one side. 28, A16.56. S Treatment and control of benign prostatic hyperplasia (BPH) and prevention of urologic events to reduce the risk of acute urinary retention, reduce the risk of surgery including transurethral resection of the prostate (TURP) and prostatectomy. P 1 tab. daily for at least 6 months.
Q Contraindicated. D Women and children. B Carefully monitor patients for obstructive uropathy. Exclude prostate cancer by digital rectal examination and, if necessary, determination of PSA, prior to and during therapy. Contains lactose. A Impotence, decreased libido, ejaculation disorders, decreased volume of ejaculate, breast tenderness, breast enlargement and rash.
FINTRID
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 necessary, determination of PSA. A Impotence, reduced libido, reduced volume of ejaculation.
FLOLAN
GSK
2NO Prostaglandin. Epoprostenol 500mcg (as Na salt). Powder and solvent for soln for inf. 1 each, A122.69. S In renal dialysis when use of heparin carries a high risk of causing or exacerbating bleeding or when heparin is otherwise contraindicated. P Prior to dialysis, 4ng/kg/min IV for 15 mins. During dialysis, 4ng/kg/min into arterial inlet of the dialyser. D CHF arising from severe LV dysfunction. Do not use chronically in patients who develop pulmonary oedema during dose-ranging. B Monitor BP and heart rate during admin. Pregnancy and lactation (only if essential). C Caution: Anticoagulants, other vasodilators, NSAIDs. A Facial flushing, headache, GI disorders, jaw pain, dry mouth, lassitude, inf. site reaction, chest pain, decreased platelet count, tachycardia, bradycardia, anxiety, agitation. +
FLOTROS
Galen
2O Anticholinergic. Trospium Cl 20mg. Round, white film-ctd tab. 60, A19.72 S Urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (e.g. idiopathic or neurologic detrusor overactivity). P 1 tab. twice a day. Severe kidney dysfunction: 1 tab. once a day or every second day. Reassess every 3-6 months. Q Under 12 years, not recommended. D Urinary retention, severe GI dysfunctions (incl. toxic megacolon, severe colitis ulcerosa), myasthenia gravis, narrow-angle glaucoma, tachyarrhythmias. B Exclude organic causes of frequency, urgency and urge incontinence (heart or kidney diseases, polydipsia, urinary organs infections and tumours) before starting treatment. Caution: GI tract obstructions (e.g. pyloric stenosis), urinary obstructions (with risk of residual urine formation), autonomous neuropathy, hiatus hernia, oesophagitis, hyperthyroidism, coronary diseases, CHF, slight to moderate liver insufficiency, renal insufficiency. Pregnancy, lactation. Contains lactose. C Anticholinergics , b-sympathomimetics, prokinetics (e.g. metoclopramide, cisapride). Avoid medications containing guar, cholestyramine and colestipol. A GI disorders.
FOZNOL
Shire
2MO Phosphate binder. Lanthanum (as carbonate hydrate) 250mg, 500mg, 750mg, 1000mg. White, round, beveled-edge flat tabs. marked S405/ strength. 250mg-90, A120.60; 500mg-90, A161.01; 750mg-90, A214.68; 1000mg-90, A227.55. S Hyperphosphataemia: In chronic renal
182
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
AND BLADDER DISORDERS
7.3
P Non diabetic and diabetic overt/ incipient nephropathy: Initially 1.25mg once daily titrate according to response; max. 5mg once Selective a1 blocker. Terazosin (HCl dihydrate) daily. Discontinue diuretic at least 2-3 days. 1mg, 2mg, 5mg, 10mg. White, yellow, brown and Hepatic impairment: Max. 2.5mg once daily. blue tabs. resp. marked with logo and triangular Prevention of progression of microalbuminuria to symbols. Starter pack-7 x 1mg plus 7 x 2mg, overt nephropathy: Initially 2.5mg once daily A8.45; 2mg-28, A15.35; 5mg-28, A20.73; 10mgincreasing gradually to double the dose after 1 28, A29.16. week and after another 3 weeks to 10mg usual S BPH. maintenance dose. P Initially 1mg at bedtime increasing to 5- R Consider initial dose of 1.25mg daily. 10mg once daily at bedtime. Dose titrated according to need for BP control. Q Not recommended. Q Not recommended. B History of syncope. Hepatic impairment. D History of angiooedema. Aortic stenosis C Antihypertensives, diuretics. or outflow obstruction. Renal artery stenosis, A Syncope with initial dose. Dizziness, hypotensive or haemodynamically unstable states. postural hypotension, lassitude, peripheral Pregnancy, lactation. oedema. B CHF, hepatic impairment, blood dyscrasias. Renal impairment: Reduce dose and INSTILLAGEL Farco assess renal function prior to and during treatment. Caution: Patients with hyper stimulated 2O angiotension system. Electrolyte monitoring Local anaesthetic/disinfectant. Lignocaine (HCl) recommended. Haemodialysis (avoid in patients 2%, chlorhexidine gluconate 0.05%, methyl hydroxybenzoate 0.06%, propyl hydroxybenzoate dialysed with high flux membranes). Malignant 0.025%. Gel in disposable syringe. 6ml, 98c; 11ml, hypertension: Initiate in hospital under close supervision. Symotomatic hypotension, A1.23. agranulocytosis/bone marrow depression, S Local anaesthesia disinfection and hyperkalaemia have been reported rarely. Caution: instrument lubrication in urethral catheterisation GLYPRESSIN Ferring Surgery and during anaesthesia. and cystoscopy. 2N C Antihypertensive agents, K+sparing V Instil 6-11ml into the urethra after Vasopressin analogue. Terlipressin acetate 1mg. diuretics, K+suppl., lithium, sympathomimetics, external disinfection; see SPC. Powder and solvent for soln for inj. 5 vials, antidiabetic agents, NSAIDs. B Severe local haemorrhage. A180.20. A Nausea, dizziness, headache, dry tickling S Emergency treatment of type 1 KENTERA Recordati cough. hepatorenal syndrome, as defined by IAC 2MO LYRINEL XL Janssen-Cilag (International Ascites Club). Antispasmodic-anticholinergic. Oxybutynin 36mg P 3-4mg every 24 hours as 3 or 4 admin. 2MO releasing 3.9mg / 24 hrs. Transdermal patch. 8, Continue until serum creatinine falls below Anticholinergic-antispasmodic. Oxybutynin (HCl) A37.10. 130mcmol/litre or by r 30%. If no reduction in 5mg, 10mg. Round yellow or pink prolongedS Urge incontinence and/or increased serum creatinine after 3 days stop treatment. release tabs. marked 5 XL or 10 XL resp. 5mg-30, urinary frequency and urgency as may occur in Duration: Approx. 10 days. A18.42; 10mg-30, A36.84. patients with unstable bladder. Q Not recommended. S Adults and elerly: Urge incontinence P 1 applied twice weekly to dry, intact D Septic shock. Pregnancy, lactation. and/or increased urinary frequency associated with skin on abdomen, hip, or buttock. Avoid B Hypertension, dysrhythmias, renal urgency as may occur in patients with unstable reapplication to same site within 7 days. dysfunction, cerebral or peripheral vascular bladder. Children over 6 years: Symptomatic Q Children or adolescents, not disease, asthma, respiratory failure or coronary treatment of detrusor hyperreflexia secondary to a recommended. insufficiency. Elderly. Monitor cardiovascular neurogenic condition. D Urinary retention, severe GI condition, system, haematology and electrolytes regularly. myasthenia gravis, narrow-angle glaucoma and in P Initially, 5mg once daily swallowed Prior to therapy confirm patient has acute whole with liquid. After one week, may be patients at risk for these conditions. Pregnancy functional renal failure (and that it is unresponsive (unless clearly necessary), lactation. increased to 10mg once daily, with subsequent to a suitable plasma expansion therapy). increments or decrements of 5mg/day, with min. B Caution: Hepatic or renal impairment, C b-blockers and drugs known to induce one-week interval between dose changes. Max. bladder outflow obstruction, GI obstructive 20mg daily. bradycardia e.g. propofol. disorders, UC, intestinal atony, hiatus hernia/GI Q 5mg once daily, increased in 5mg A Paleness, increased BP, abdominal pain, reflux, autonomic neuropathy, cognitive nausea, diarrhoea, headache. impairment or Parkinson’s disease. Elderly. Driving/ increments up to max. of 15mg once daily. D Narrow-angle glaucoma or shallow operating machines. anterior chamber, myasthenia gravis, urinary HYPOVASE Pfizer C Caution: CYP3A4 substrates or retention, GI obstructive disorder, paralytic ileus, 2MO inhibitors, other anticholinergics, antihistamines, intestinal atony, severe ulcerative colitis, toxic antipsychotics, quinidine, TCAs, atropine, Selective a-blocker. Prazosin (HCl) 500mcg, 1mg. megacolon, urinary frequency and nocturia due to prokinetic therapies, bisphosphonates. White tab. marked Pfizer and white tab. scored heart or renal failure. Porphyria. Lactation. A Appl. site reactions, UTIs, vision and marked M6, resp. B.D. Starter pack (8 x B Monitor for anticholinergic CNS effects 500mcg plus 32 x 1mg), A4.49; 500mcg-56, A3.17;. abnormalities, dizziness, somnolence, headache, (particularly after beginning treatment or dose dry mouth, GI disorders. 1mg-56, A4.07. increases). Caution: Frail elderly, GI mobility S BPH. disorders, hepatic or renal impairment, bladder sanofi-aventis P Initially 500mcg twice daily for 3-7 days LOAVEL outflow obstruction, GORD and/or patients taking 2MO initial dose admin. in the evening; maintenance drugs that can cause or exacerbate esophagitis, 2mg twice daily. ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, pre-existing dementia treated with cholinesterase Q Not recommended. 10mg. White, yellow, red and white oblong tabs. inhibitors, UTI. May aggravate hyperthyroidism, D Sensitivity other quinazolines. with score line on both sides. 1.25mg-28, A5.29; CHF, cardiac arrhythmia, tachycardia, hypertension, A A B Pregnancy, lactation. Initial low dose 2.5mg-28, 7.48; 5mg-28, 10.41; 10mg-28, prostatic hypertrophy. May lead to decreased A14.13. and gradual titration is recommended, monitor salivary secretions. Monitor visual acuity and BP. intraocular pressure; advise patients to seek advice S Non diabetic and diabetic overt/ C Other antihypertensives. Caution: PDE-5 incipient nephropathy. Prevention of progression immediately in case of sudden loss of visual acuity. Pregnancy (only if benefit outweighs risk). Driving/ of microalbuminuria to overt nephropathy. inhibitors.
failure patients on haemodialysis or continuous ambulatory peritoneal dialysis and in adults with chronic kidney disease, not on dialysis, with serum phosphate levels r1.78 mmol/L in whom a low phosphate diet alone is insufficient to control 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/ L 750mg; 2.4-2.9mmol/L 1500mg; q2.9mmol/ L 2250mg). Titrate every 2-3 weeks until acceptable serum phosphate level reached. Q Under 18 years, not recommended. D Hypophosphataemia. Pregnancy, lactation. B Monitoring of liver function tests recommended. Renal insufficiency (monitor serum Ca+ levels). Acute peptic ulcer, UC, Crohn’s disease or bowel obstruction. Long-term admin. (q2 yrs). Discontinue if hypophosphataemia develops. May cause abdominal x-rays to have a radio-opaque appearance. Driving/using machines. C 2 hrs apart: Drugs interacting with antacids (e.g. chloroquine, hydroxychloroquine, ketoconazole), tetracycline, doxycycline, floxacins. A GI disorders, hypocalcaemia.
HYTRIN
Amdipharm
2MO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
183
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
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 MIMPARA Amgen history of bleeding requiring transfusions, platelet 2NT levels q500x109/l. Not indicated for cancer patients. Hb in excess associated with life Anti-parathyroid agent. Cinacalcet 30mg, 60mg, threatening cardiovascular complications. 90mg. Light green, oval, film-ctd tabs. marked AMGEN on one side and 30, 60 and 90 resp. on Pregnancy. Lactation (assess risk benefit). the other. 30mg-28, A214.11; 60mg-28, A395.27; A Hypertension. 90mg-28, A592.91. S Secondary hyperparathyroidism (HPT) in NEORAL Novartis patients with end-stage renal disease on 2MT maintenance dialysis therapy, as part of a regimen Fungal metabolite immunosuppressant. with phosphate binders and vit. D sterols as Cyclosporin 25mg blue-grey oval cap., 50mg appropriate. Reduction of hypercalcaemia in yellow-white oblong cap.; 100mg blue-grey patients with parathyroid carcinoma. P HPT: Initially, 30mg once per day taken oblong cap. All marked with S in a triangle and cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; whole with food or shortly after meal. Titrate 100mg-30, A96.03. every 2-4 weeks to max. 180mg once daily to
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, 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.
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 severe hepatic impairment. Do not initiate if serum Ca++ below the lower limit of the normal range. Monitor for hypocalcaemia. May cause isolated cases of hypotension and/or worsening HF. Pregnancy, lactation (only if benefit outweighs risk). C Caution: Strong inhibitors or inducers of CYP3A4 and/or CYP1A2, substrates of CYP2D6 with narrow therapeutic index, smoking. A Nausea, vomiting, anorexia, dizziness, paraesthesia, rash, myalgia, asthenia, hypocalcaemia, reduced testosterone levels.
2MT
ALSO NEORAL ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A143.89. S Steroid dependent and steroid resistant nephrotic syndrome due to glomerular diseases. V See lit. D Uncontrolled hypertension, uncontrolled infection. Malignancy. B Only use under specialist supervision. Closely monitor renal and liver function, BP and serum lipids, serum K+. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. Active herpes simplex infections should be cleared before treatment. Not 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, nephrotoxic drugs, oral contraceptives, MIRCERA Roche propafenone, prednisolone, methylprednisolone, K+suppl., K+sparing diuretics, lipid solutions, 5NT NSAIDs, doxycycline, sulphadiazine, IV Continuous erythropoietin receptor activator. Methoxy polyethylene glycol-epoetin beta 30, 50, sulphadimidine, IV trimethoprim, diclofenac, nifedipine, grapefruit juice. 75, 100, 120, 150, 200 and 250mcg in 0.3ml. Soln A Renal and hepatic dysfunction, for inj. in pre-filled syringe. Pack of 1, price on hypertension, tremor, GI disturbances, request. hypertrichosis, gingival hypertrophy, malignancies, S Symptomatic anaemia associated with lymphoproliferative disorders, burning sensations chronic kidney disease. P Erythropoiesis Stimulating Agent (ESA)- (feet and hands), fatigue, muscle weakness or cramp, myopathy. Rarely hyperkalaemia, naive patients: 0.6mcg/kg once every two weeks hyperuricaemia, hypomagnesaemia, until Hb q10g/dL by single inj. IV or SC. Increase hypercholesterolaemia, oedema, convulsions, dose by approx. 25% if Hb rise Q 1g/dL/month. headache, rash, mild anaemia, haemolytic uraemic Continue 25% increase at monthly intervals until syndrome, weight gain, pancreatitis, colitis, Hb target is reached ; then switch to monthly dosing at double the fortnightly dose. Converting paraesthesia, neuropathy, confusion, dysmenorrhoea, amenorrhoea, gynaecomastia, from current ESA: Start as single injection once monthly at next scheduled dose (see SPC). encephalopathy.
184
NEORECORMON
Roche
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 MI, stroke, have unstable angina, are at risk of DVT. B Hypertension, thrombocytosis. History of epilepsy. Chronic hepatic failure. Correct other causes of anaemia; iron suppl. may be necessary. Monitor Hb, BP, platelet count, serum electrolytes. 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.
NORDURINE
Ferring
2MO Vasopressin and analogues. Desmopressin (acetate) 0.1mg, 0.2mg. White, oval, convex tab. with single score, engraved 0.1 or 0.2. 0.1mg-30, A19.57; 90, A58.65; 0.2mg-30, A39.13; 90, A117.39. S Cranial diabetes insipidus incl. posthypophysectomy polyuria/polydipsia, primary nocturnal enuresis in patients from 5-65 years. Symptomatic treatment of nocturia in adults up to 65 years only, associated with nocturnal polyuria. R Over 65 years, contraindicated. V Diabetes insipidus: Initially 0.1mg three times daily; maintenance 0.1-0.2mg three times daily. Primary nocturnal enuresis: Initially 0.2mg at bedtime increasing up to 0.4mg. Nocturia: Initially 0.1mg at bedtime increasing up to 0.2mg and subsequently 0.4mg by weekly dose escalations. 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,
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 the day. Q Not applicable. D History of orthostatic hypotension, severe hepatic insufficiency. outweigh risks). Contains sucrose, Na+. B Hypotension may occur. Perform rectal C Avoid other oral medicinal products within 2 hrs before and 3 hrs after admin. Caution: examination, and if necessary PSA determination before therapy and periodically thereafter. Severe Tetracyclines, biphosphonates, fluorides, some renal impairment (Q10ml/min). quinolones (e.g. ciprofloxacin), some C Caution: Diclofenac and warfarin, other cephalosporins (e.g. cefpodoxime, cefuroxime), a1-adrenoceptor antagonists. ketoconazole, estramustine-preparations, anticholinergics, zinc, urso- and chenodesoxycholic A Dizziness. acids, halofantrine, iron, vit. D and derivatives, PROSCAR MSD thiazide diuretics, glycosides, adrenaline, levothyroxine, oestrogens, digoxin, nitrofurantoin, 2 N O penicillamine. Selective 5-a reductase inhibitor. Finasteride 5mg. A GI disorders, hypercalcaemia, Blue apple-shaped film-ctd tab. marked with tab. asymptomatic hypermagnesaemia. name and MSD 72. 28, A28.49. S Treatment and control of benign PHOSEX Biofact prostate hypertrophy (BPH) to cause regression of 2MO the enlarged prostate, improve urinary flow, and improve symptoms associated with BPH in patients Phosphate binder. Ca++ acetate 1g (equiv to Ca++ who have enlarged prostate and are not 250mg). Yellow oval tab. marked PHOS-EX. 180, A27.29. immediate candidates for surgery. Prevention of S Correction of hyperphosphataemia with urological events to reduce risk of acute urinary retention and need for surgery in patients with chronic renal failure in patients undergoing BPH. dialysis. P Initially, 1 tab, swallowed whole during P Males only, 1 daily for at least six months to assess response. Thereafter treatment meals, 3 times daily. Titrate to desired serum 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. A GI disorders, hypocalcaemia. enlargement, rash, hypersensitivity reactions incl. pruritus, urticaria, swelling of lips and face, PROFAL Actavis testicular pain.
Astellas if diarrhoea occurs. Pregnancy (only use if benefits
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
7.3
digitalis glycosides, only admin. under ECG control and monitoring of serum Ca++ level. Reduce dose
weight gain, in severe cases convulsions.
OMNEXEL
AND BLADDER DISORDERS
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.
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 OSVAREN Fresenius Medical Care improve the symptoms associated with BPH and to reduce the incidence of acute urinary retention 2MO and the need for surgery including transurethral Phosphate binder. Ca++ acetate, 435mg (eq. to 110mg Ca++ ), Mg++ carbonate, 235mg (eq. to 60mg resection of the prostate (TURP) and prostatectomy. Only for patients with an enlarged ++ Mg ) White to yellowish, oblong film-ctd tab. prostate (prostate volume q ca. 40ml). with single score line. 180, A30.13. P 5mg daily. Treatment for at least 6 S Hyperphosphataemia associated with chronic renal insufficiency in patients undergoing months may be necessary. D Women, children. dialysis (haemodialysis, peritoneal dialysis). P Initially, 3 tab. per day with a meal; may B Caution: Impaired hepatic function. be increased to 12 tab./day max. Divide daily dose Carefully monitor patients for obstructive uropathy. Exclude prostate cancer by digital rectal according to number of meals. examination and, if necessary, determination of Q Under 18 years, not recommended. PSA, prior to and during therapy. Causes decreases D Hypophosphataemia. Hypercalcaemia with or without clinical symptoms. Elevated serum in serum PSA levels (consider when evaluating PSA data). Contains lactose. Mg++ levels q 2mmol/l, and/or symptoms of A Impotence, reduced libido, reduced hypermagnesaemia. AV-block III. Myasthenia volume of ejaculate. gravis. Lactation (not recommended). B Caution (continuous monitoring of PROLOSIN Niche serum Ca++, Mg++ and phosphate): Severe 2MO hyperphosphataemia refractory to therapy, Selective a1-blocker. Tamsulosin (HCl) 400mcg. refractory hyperkalaemia, clinical relevant Brown/buff opaque prolonged release cap., bradycardia or AV-block II with bradycardia. containing white pellets. 30, A16.52. May occur: Hypermagnesaemia, vascular and soft tissue calcifications (long-term use). Risk of S Lower urinary tract symptoms associated hypercalcaemic episodes; warn patient of possible with benign prostatic hyperplasia. symptoms of hypercalcaemia. With concomitant P 1 daily swallowed whole after 1st meal
RAMIC
Pinewood
2MO ACE inhibitor. Ramipril 2.5mg, 5mg. Hard caps. with light grey body and light green and green cap marked R on cap and strength on body. 2.5mg-28, A6.07; 5mg-28, A8.46. S Overt glomerular nephropathy. Nondiabetic/diabetic overt and incipient nephropathy. Prevention of progression of microalbuminuria to overt nephropathy.
2MO ALSO RAMIC 10MG Ramipril 10mg. Hard caps. with light grey body and dark green cap marked R on cap and 10 on body. 28, A11.54. S Prevention of progression of microalbuminuria to overt nephropathy. 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 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
185
7.3 RENAL
UROLOGY
AND BLADDER DISORDERS
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. RAMYTE Actavis Hypocalcaemia or hypercalcaemia may occur (monitor Ca++ levels). Monitor serum bicarbonate 2MO and serum chloride levels. Peritonitis may occur in ACE inhibitor. Ramipril 2.5mg, 5mg, 10mg. Size 4 patients on peritoneal dialysis (monitor). Not hard cap. containing white powder, with light indicated for hyperparathyroidism. Pregnancy grey body and resp. light green, green or dark (only use if clearly needed), lactation. green cap, marked R on cap and strength on C Not recommended: Ciprofloxacin. body. 2.5mg-28, A5.76; 5mg-28, A8.02; 10mg-28, Caution: Ciclosporin, mycophenolate mofetil, A10.92. tacrolimus, levothyroxine, anti-arrhythmics, antiS Prevention of progression of seizure medications. May affect bioavailability of microalbuminuria to overt nephropathy. P Initially, 2.5mg once daily. Double dose other medicinal products. A GI disorders. after 1 week, after 3 further weeks increase to 10mg. Maintenance: 10mg daily. Renal/hepatic RENVELA Genzyme impairment, see SPC. 2NO R Caution. Phosphate binder. Sevelamer carbonate 800mg. D History of angioneurotic oedema White to off-white tab. 180, A184.53. relating to previous ACE inhibitor treatment. 2NO Pregnancy, lactation. Use in children. B Aortic stenosis or outlaw obstruction ALSO RENVELA SUSPENSION Sevelamer carbonate (not recommended). Renal impairment risk 2.4g. Pale yellow powder. 60, A184.53. (dosage reduction and/or discontinue); assess renal S Hyperphosphataemia: In adults receiving function prior to and during treatment. Caution: haemodialysis or peritoneal dialysis and in adults Impaired liver function, volume- and salt-depletion with chronic kidney disease, not on dialysis with (symptomatic hypotension risk), anaesthesia, serum phosphorus r1.78mmol/l. surgery. May occur rarely: Agranulocytosis and P Initially 2.4g or 4.8g per day based on bone marrow depression, reduction in red cell clinical needs and serum phosphorus level (see count, haemoglobin content and platelet count, SPC). Must be taken 3 times/day with meals. hyperkalaemia, hyperkalaemia (hypertensive Monitor serum phosphorus levels and titrate patients), angioneurotic oedema. Avoid sevelamer carbonate every 2-4 weeks until haemodialysis using high flux polyacrylonitrile acceptable serum phosphorus level reached, with membranes and low-density lipoprotein apheresis regular monitoring thereafter. with dextran sulphate. Q Under 18 years, not recommended. C Caution: Antidiabetics, NSAIDs. D Hypophosphataemia. Bowel obstruction. A Nausea, dizziness, headache, B Not recommended for chronic kidney symptomatic hypotension, MI, cerebrovascular disease patients not on dialysis with serum accident, chest pain, palpitations, rhythm phosphorus Q1.78mmol/l. Caution: Dysphagia, disturbances, angina pectoris, impaired renal swallowing disorders, severe GI motility disorders, function, GI disorders, hypersensitivity reactions, gastric contents retention,abnormal / irregular cutaneous and mucosal reactions, vasculitis, muscle bowel motion, active IBD, major GI tract surgery, and joint pains, fever or eosinophilia, dry tickling long-term chronic treatment. Intestinal obstruction cough, disturbances of balance, nervousness, or ileus/subileus may occur; monitor constipated restlessness, terror, sleep disorders, confusion, loss patients and re-evaluate treatment if severe of appetite, depressed mood, feeling of anxiety, constipation or other severe GI symptoms occur. paraesthesiae, taste change/reduction/loss, muscle Monitor fat-soluble vitamins, folic acid. cramps, erectile impotence, reduced sexual desire, Hypocalcaemia or hypercalcaemia may occur increased blood urea nitrogen and serum (monitor Ca++ levels). Monitor serum bicarbonate creatinine, deterioration of pre-existing levels. Peritonitis may occur in patients on proteinuria. peritoneal dialysis (monitor). Not indicated for hyperparathyroidism. Pregnancy (only use if clearly RENAGEL Genzyme needed), lactation. C Not recommended: Ciprofloxacin. 2NO Caution: Ciclosporin, mycophenolate mofetil, Phosphate binder. Sevelamer HCl 800mg. Offtacrolimus, levothyroxine, anti-arrhythmics, antiwhite oval film-ctd. tab. marked with tab. name seizure medications. May affect bioavailability of and strength. 180, A184.53. S Hyperphosphataemia in adults receiving other medicinal products. A GI disorders. haemodialysis or peritoneal dialysis, as part of multiple therapeutic approach to control renal RETACRIT Hospira bone disease development. 5NT P Initially 2.4g or 4.8g per day based on Erythropoietin. Epoetin zeta. Clear, colourless sln clinical needs and serum phosphorus level (see for inj. in pre-filled syringe. 1000 IU/0.3ml-6, SPC). Must be taken 3 times/day with meals. A54.59; 2000 IU/0.6ml-6, A104.82; 3000 IU/0.9ml-6, Monitor serum phosphorus levels; adjust Renagel dose accordingly. Test serum phosphate every 2-3 A155.05; 4000 IU/0.4ml-6, A203.83; 5000 IU/0.5mlweeks until stable serum phosphate level reached 6, A272.98; 6000 IU/0.6ml-6, A314.47; 8000 IU/ 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.
186
0.8ml-6, A436.76; 10,000 IU/1ml-6, A509.56; 20000IU/0.5ml-1, A182.01; 30000IU/0.75m-1, 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 accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. P 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. 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. Q Haemodialysis: Correction phase as per adults. Maintenance, see SPC. D Patients with Pure Red Cell Aplasia (PRCA) following treatment with erythropoietin. Uncontrolled hypertension. Patients unable to receive adequate antithrombotic prophylaxis. 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. 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. A273.01;
ROWATINEX
Rowa
2 Volatile oils. Essential oils a pbinenes 3.1g, camphene 1.5g, borneol 1g, anethol 400mg, fenchone 400mg, cineole 300mg, olive oil to 10g. Yellow ent-ctd spherical gelatin cap. 50, A5.97. S Urolithiasis. Renal disorders. Prevention of urinary stone formation. P 1-2 caps four or five times daily before meals. In presence of colic, 2-3 caps four or five times daily. Q Under 6 years, not recommended; 6-14 years, 1 cap twice daily before meals. D Pregnancy, lactation. B Oral anticoagulants and other agents metabolised by the liver. C Oral anticoagulants and other agents metabolised by the liver.
SANDIMMUN
Novartis
2MT Fungal metabolite immunosuppressant. Cyclosporin 25mg pale pink oval cap., 50mg yellow oblong cap.; 100mg dusky pink oblong cap. 1 25mg-30, A29.01; 50mg-30, A53.77; 100mg-30, A105.50.
2NT ALSO SANDIMMUN ORAL SOLUTION Cyclosporin
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
100mg/ml. Oral soln. 50ml, A163.91. S Steroid dependent and steroid resistant nephrotic syndrome owing to glomerular diseases. V See lit. D Hypersensitivity to cyclosporin. Impaired renal function, uncontrolled hypertension, uncontrolled infection. Malignancy other than of skin. B Monitor renal and liver function, BP and serum lipids. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. C Systemic antibiotics, live vaccines, phenytoin, ketoconazole, fluconazole, 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.
TAMNIC
Clonmel
2MO 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, A15.07. S Lower urinary tract symptoms associated with BPH. P 1 daily swallowed whole after 1st meal of the day. 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. Cataract surgery (discontinue 1-2 weeks prior; do not initiate if surgery scheduled). C Caution: Diclofenac and warfarin, other a1-adrenoceptor antagonists. A Dizziness.
TAMSU
Rowex
2MO 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
AND BLADDER DISORDERS
7.3
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 symptoms of BPH. ACE inhibitor. Ramipril 1.25mg, 2.5mg, 5mg, P 10mg daily, taken immediately after the 10mg. White, yellow, red and white oblong tabs. same meal each day. Swallow tab. whole with with score line on both sides. 1.25mg-28, A4.31; fluid and take initial dose at bedtime. 2.5mg-28, A6.10; 5mg-28, A8.50; 10mg-28, A11.57. Q Not recommended. D Conditions with orthostatic hypotension. S Non diabetic and diabetic overt/ Hepatic insufficiency. Severe renal impairment (no incipient nephropathy. Prevention of progression data). of microalbuminuria to overt nephropathy. B Transient postural hypotension may P Non diabetic and diabetic overt/ develop. Caution: Hypersensitivity to other a1incipient nephropathy, the initial dose is 1.25mg once daily titrate according to response; max. 5mg blockers, 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 TOVIAZ Pfizer stenosis, outflow obstruction. Pregnancy, lactation. Hypersensitivity to ramipril. 2NO B CHF, hepatic impairment, blood Anticholinergic. Fesoterodine 4mg, 8mg. Resp., dyscrasias. Renal impairment: reduce dose and light blue or blue, oval, biconvex, film-ctd, assess renal function prior to and during prolonged-release tabs, engraved FS or FT on one treatment. Haemodialysis (avoid in patients side. 4mg-28, A40.00; 8mg-28, A43.39. dialysed with high flux membranes). Use with S Symptoms (increased urinary frequency caution in surgery and during anaesthesia. and/or urgency and/or urgency incontinence) that C Antihypertensive agents, K+sparing may occur in patients with overactive bladder diuretics, K+suppl., lithium, antidiabetic agents, syndrome. NSAIDs. P Initially, 4mg once daily. May be A Nausea, vomiting, dizziness, fatigue, increased to 8mg once daily (max daily dose). Full headache, abdominal pain, diarrhoea, cough. Liver treatment effect between 2-8 weeks; re-evaluate dysfunction, renal impairment, hypersensitivity efficacy after 8 weeks. Concomitant potent reactions. Rarely, symptomatic hypotension, CYP3A4 inhibitors: Normal hepatic/renal function, angioneurotic oedema, syncope. max dose 4mg once daily; impaired hepatic/renal function, see SPC. URISPAS Recordati Q Under 18 years, not recommended. 2MO D Urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia Antispasmodic. Flavoxate (HCl) 200mg. White sugctd tab. marked URISPAS 200. 90, A11.53. gravis, severe hepatic impairment (Child Pugh C), S Incontinence, frequency, urgency, concomitant potent CYP3A4 inhibitors (moderate nocturia and dysuria. to severe hepatic or renal impairment), severe ulcerative colitis, toxic megacolon. Hypersensitivity P 1 three times daily. Q Not recommended. to peanut or soya. Pregnancy, lactation. D Obstructive conditions of GI or urinary B Assess other causes of frequent tracts. urination (incl. organic) before initiating. Neurogenic cause for detrusor overactivity (safety B Suspected glaucoma. Pregnancy. A Headache, nausea, fatigue, diarrhoea, and efficacy not established). Treat infection if blurred vision, dry mouth. present. Caution: Bladder outflow obstruction at a1-adrenoceptor antagonists. A Dizziness.
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,
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
187
8.1 ANTIBACTERIAL
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. Q Not applicable. D Conditions with orthostatic hypotension. Hepatic insufficiency. B Severe renal impairment (not recommended). Transient postural hypotension may develop. Caution: Hypersensitivity to other a1blockers, 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.
XATRAL
Sanofi
2MO Selective a1-blocker. Alfuzosin (HCl) 2.5mg. White film-ctd tab. marked XATRAL 2.5. 60, A20.67.
188
ANTI-INFECTIVES
DRUGS S Functional symptoms of BPH. P 1 three times daily. Max. 4 daily. Renal insufficiency: Initially 1 twice daily. Hepatic insufficiency: Initially 1 daily, increased to 2 depending on response. R Initial dose 1 morning and evening.
2MO
sweating, decreased appetite, flushing, abdominal pain, chills, insomnia, anxiety, sleep disorder, agitation, decreased libido.
ZEMPLAR
Abbott
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. C Phosphate or vit. D-related compounds, YENTREVE Lilly alum.- or magn.-containing preparations; do not 2NO take concomitantly. Caution: Digitalis, Ca++containing preparations or thiazide diuretics. 5-HT/NA reuptake inhibitor. Duloxetine (HCl) A Hypercalcaemia, hyperphosphataemia, 20mg, 40mg. Hard gastro-resistant caps. Opaque parathyroid disorder, pruritus, taste perversion. blue cap and body marked 20mg and 9544. Opaque orange body and blue cap marked 40mg 8.1 ANTIBACTERIAL DRUGS A A and 9545. 20mg-28, 19.58; 40mg-56, 39.96. S Moderate to severe stress urinary ALTARGO GSK incontinence (SUI) in women. 2NO P 40mg twice daily. A starting dose of 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 have been reported. Hyponatraemia reported area q100cm2, impetiginous lesions q10 with rarely in elderly. Suicidal ideation and behaviour total surface area q100cm2. Sensitisation or severe (monitor for depressive symptoms). Akathisia may local irritation (discontinue if occurs). Contains develop during the first few weeks. Contains butylated hydroxytoluene. Keep away from eyes/ sucrose. mucous membranes. Do not use to treat MRSA C Contra: Non-selective irreversible MAOIs infections, nor abscesses. Pregnancy, lactation (or within 14 days of discontinuation), CYP1A2 (assess risk/benefit). inhibitors (fluvoxamine, ciprofloxacin, enoxacin). C Avoid other topical products to same Avoid antidepressants (especially SSRIs, SNRIs, area. reversible MAOIs but also clomipramine, A Application site reactions, irritation. amitriptyline, venlafaxine, triptans, tramadol, tryptophan), other duloxetine-containing drugs. AMIKIN BMS Caution: Anticoagulants, alcohol, CYP2D6 2NO substrates (TCAs), sedatives (benzodiazepines, Aminoglycoside. Amikacin (sulph.) 100mg/2ml, morphinomimetics, antipsychotics, phenobarbital, 500mg/2ml. Vial. 50mg/2ml x 5- A13.75; 250mg/ sedative antihistamines), flecainide, lecainide, 2ml x 5- A59.03. propafenone, metoprolol, smoking. St Johnâ&#x20AC;&#x2122;s S Serious infections due to amikacin Wort. A GI disorders, fatigue/asthenia, headache, sensitive organisms. P 15mg/kg IM or IV daily in two divided dizziness, tremor, lethargy, somnolence, paraesthesia, blurred vision, vertigo, increased doses for up to 10 days; total max. 15g. UTI, 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.
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 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.
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 AMOCLAV Rowex suspension 3 times daily. 2-6 years, 5ml paediatric suspension 3 times daily. Renal impairment, 2NO haemodialysis patients, see SPC. b-lactamase inhibitor/broad-spectrum penicillin. D Hypersensitivity to penicillin or Amoxicillin (as amoxicillin trihydrate) / clavulanic cephalosporins. Previous history of amoxicillin+ acid (as K clavulanate) 250/125mg. Oblong, clavulanate associated jaundice or hepatic convex, off-white, scored film-ctd tab. embossed dysfunction. AXC375, one side and G twice on the other. 21, B Not recommended: Infectious A6.08. mononucleosis, lymphatic leukaemia. Caution: 2NO Long term use, history of allergic reactions (risk of ALSO AMOCLAV DUO Amoxicillin (as amoxicillin anaphylaxis), asthma, liver and renal dysfunction, trihydrate) / clavulanic acid (as K+ clavulanate) 500/ elderly; monitor regularly. In case of severe GI 125mg. White, oblong, biconvex film-ctd tab. disturbances parenteral therapy is recommended. scored on both sides. 14, A6.88. May occur: Pseudomembranous colitis, S Infections of the respiratory tract, ENT, epileptiform convulsions, superinfections. May genito-urinary tract, abdominal, skin and soft prolong bleeding time and prothrombin time. tissue. May precipitate in the bladder catheter at high P One 250mg/125mg tab. 3 times daily or urinary concentrations. Pregnancy (avoid unless one 500mg/125mg tab. twice a day taken at start necessary), lactation. Suspension contains of meal. Severe cases: May increase to two 250mg/ aspartame. 125mg tabs. 3 times a day. Duration: Should not C Not recommended: Bacteriostatic exceed 14 days without review. Renal impairment: chemotherapeutics/antibiotics (e.g. tetracyclines, Moderate, cc: 10-30ml/min: One 250mg/125mg macrolides, sulphonamides, chloramphenicol), tab. or one 500mg/125mg tab. 12 hourly; severe, disulfiram. Caution: Probenecid, allopurinol, ccQ 10ml/min: One 250mg/125mg tablet 12 digoxin, anticoagulants, hormonal contraceptives. hourly. Haemodialysis patients: One 500mg/125mg May affect laboratory tests (non-enzymatic tab. every 24 hours plus 1 during dialysis; to be methods for determining urinary sugar, repeated at end of dialysis. urobilinogen test). Q Over 12 years, as per adults; under 12 A Hypersensitivity reactions, skin reactions years, not recommended. (exanthema, pruritus). GI disorders, increased liver 2NO enzymes levels, haematological changes.
ANTIBACTERIAL DRUGS 8.1 AMOXIL
GSK
2NO Broad-spectrum penicillin. Amoxycillin (trihydrate) 250mg, 500mg. Maroon/gold caps. marked with cap. name and strength. 250mg-21, A3.18; 500mg21, A5.16; 500mg-100, A24.58.
2NO ALSO AMOXIL SYRUP Amoxycillin (trihydrate) 125mg/5ml. Susp. Powder for 100ml, A1.54.
2NO ALSO AMOXIL SYRUP FORTE Amoxycillin (trihydrate) 250mg/5ml. Powder for susp. Powder for 100ml, A3.09.
2NO ALSO AMOXIL PAED. SUSP. Amoxycillin (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 ALSO AMOXIL 3G SACHET Amoxycillin (trihydrate) 3g. 2, A5.12. P 250mg-500mg three times daily. High dosage therapy: 3g twice daily. Short course therapy: Two 3g doses with 10-12 hours between doses. Gonorrhoea: 3g as a single dose. Dental Abscess: Two 3g doses, 8 hours apart. Prophylaxis of Endocarditis: 3g orally, 1 hour before procedure. A 2nd dose may be given 6 hours later, if considered necessary or 1g IM inj. if oral dose not tolerated. Q Up 10 years: 125mg orally, three times daily; may increase in severe infection. Severe/ recurrent acute otitis media: 750mg orally, twice a day for 2 days may be used as alternative in age 3-10 years. Prophylaxis of Endocarditis: Under 10: v adult dose. Under 5: t adult dose.
2NO
Anti-infectives: The ideal prevention and control of infections should be based on multi-disciplinary
ALSO AMOXIL INJECTION Amoxycillin (Na+) 500mg. Powder in vials. 500mg-10, A7.77. P 500mg IM eight hourly, or 1g IV six hourly for severe infections. Q 50-100mg/kg daily in divided doses. D Hypersensitivity to penicillins or cephalosporins. B Infectious mononucleosis. A Erythematous rash.
teams implementing infection control through guidelines.
AUGMENTIN DUO
Clinical: The likely source and diagnosis of the infection, whether disseminated or localised, as well as
2NO
the underlying patient condition needs to be established.
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, A7.52; 50, A33.58. 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).
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 >38°C or <36°C in uncomplicated localised infections, tachycardia >90 bpm, tachypnoea, resp. rate >20/min, WBC, <12.0 or 4.0 x 109/L, local inflammation/purulence, hypotension, hyperglyceamia, raised ESR/plasma viscosity, raised serum complement, raised C-reactive protein. Monotherapy with a single agent is preferred. A combination of agents can be used for broad spectrum 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.
GSK
2NO ALSO AUGMENTIN DUO SUSPENSION Clavulanic acid (K+ salt) 57mg,amoxicillin (trihydrate) 400mg/ 5ml. Sugar-free. Powder for-35ml, A5.12; 70ml, A8.25. Q 7-12 years, 5ml twice daily; 2-6 years, 2.5ml twice daily; 2 months-2 years, dose according to age and body weight, 25/3.6mg/kg/ day to 45/6.4mg/kg/day, see SPC. Under 2 months, not recommended.
2NO ALSO AUGMENTIN 250/125MG Clavulanic acid (K+ salt) 125mg, amoxicillin (trihydrate) 250mg. White to off-white oval-shaped film-ctd tab. 21, A6.14;
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
189
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
100, A29.19. S Infections of the respiratory tract, ENT, UTI, skin and soft tissue. P 1-2 three times daily. Q Over 12 years, as adults; under 12 years, use susp.
arrhythmias. Impaired liver function. Severely impaired renal function. Pregnancy, lactation. B Alertness may be impaired. Predisposition to seizures, G6PD defects. Ongoing proarrhythmic conditions. Sunlight or UV rays. Tendon inflammation (discontinue). Investigate if vision becomes impaired. Elderly with renal disorders. Tabs contain lactose. Contains Na+. Driving or using machines. C Products inducing QT prolongation i.e. antiarrhythmics class Ia and III, neuroleptics, terfenadine, macrolides, antimalarials, azole antimycotics, TCADs, antimicrobials, antihistaminics, cisapride, vincamine IV, bepridil, diphemanil (all contraindicated). Drugs containing bivalent or trivalent cations (not within 6 hrs), charcoal. Caution: Anticoagulants. A Superinfection, headache, dizziness, QT prolongation in patients with hypokaleamia, GI disorders, diarrhea, abnormal liver function tests, inj. site reaction.
B Caution: Epileptics, CNS disorders, history of convulsive disorders, defects in G6PD activity, renal insufficiency, severe dehydration. Monitor: Pre-existent significant renal or hepatic disorders. Risk: Pseudomembranous colitis (discontinue), crystalluria (patients should be well hydrated). Avoid direct exposure to UV-light. 2NO + Tendon inflammation and rupture, particularly ALSO AUGMENTIN PAEDIATRIC Clavulanic acid (K elderly or concurrent treatment with salt) 31.25mg, amoxicillin (trihydrate) 125mg/5ml. corticosteriods. Powder for susp. Powder for 100ml, A3.42. C Theophylline (monitor plasma levels, Q Under 3 months, no oral presentation potentially life-threatening). Phenytoin, currently available; 3-9 months, 2.5ml half glibenclamide, cyclosporine, methotrexate, NSAIDs, strength paediatric susp. three times daily; 9 metoclopramide, anticoagulants, probenecid. months-2 years, 5ml half strength paediatric susp. Cationic drugs, mineral suppl., sucralfate, antacids, three times daily; 2-6 years, 5ml paediatric susp. highly buffered drugs; do not use within 4 hrs. three times daily. 2-6 years, severe infections, 10ml Avoid: Concurrent admin. of dairy products or Ca++ three times daily. fortified drinks. 2N A GI and CNS disturbances, cardiovascular ALSO AUGMENTIN INTRAVENOUS Clavulanic acid disorders, hypersensitivity/skin reactions, hepatic/ (K+ salt) 100mg, amoxicillin (Na+ salt) 500mg. renal disturbances, moniliasis, asthenia, Clavulanic acid (K+ salt) 200mg, amoxicillin (Na+ hyperglycaemia, abnormal gait, pain, salt) 1g. Powder in vials. 600mg-10, A19.23; 1.2gAZACTAM BMS thrombophlebitis, reversible arthralgia, joint 10, A38.47. swelling, myalgia, effects on haematological 2N V See SPC. parameters, abnormal laboratory findings. 2NO Monobactam. Aztreonam 500mg, 1g, 2g. Powder ALSO AUGMENTIN 875/125MG Clavulanic acid (as in vials. Vials-5 x 500mg, A30.67; 1 x 1g, A12.26; 1 BIRAVID Ergha x 2g, A24.50. K+) 125mg, amoxicillin (trihydrate) 875mg. White 2NO to off white film ctd tab. marked Augmentin. 14, S Gram-negative infections. A27.95. 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 P Mild to moderate infection: 1 twice FXN and 200. 20, A10.81. daily at the start of a meal. Severe infections: 1 six to eight hourly IV; max. 8g daily. UTI, 0.5-1g three times daily. Moderate or severe renal S Acute, chronic or recurrent respiratory eight to twelve hourly IM or IV. Gonorrhoea/ impairment: See SPC. tract infections (RTI), e.g. bronchitis. Acute and cystitis, 1g single dose IM. Q Under 12 years, not recommended. Q Under 1 week, not recommended; over chronic urinary tract infections (UTI). D Hypersensitivity to penicillin or 1 week, 30mg/kg eight hourly; over 2 years, severe Uncomplicated non-gonococcal gonorrhoea, noncephalosporins, previous history of co-amoxiclavgonococcal urethritis and cervicitis. Infection infections, max. 50mg/kg six hourly. Max. total associated jaundice/hepatic dysfunction. prophylaxis in neutropenic patients. Skin and soft daily dose 8g. B Pregnancy, lactation. Liver or renal tissue infection. D Pregnancy. impairment. Avoid in infectious mononucleosis. P RTI: 400mg daily; may be increased to B Renal or hepatic dysfunction. Penicillin Monitor organ system functions during prolonged or cephalosporin sensitivity. Lactation. 400mg twice daily. UTI: 200-400mg daily; upper therapy. UTI, increase if necessary to 400mg twice a day. A Skin rashes, diarrhoea, vomiting. Local C Probenecid (not recommended). Caution: reactions at inj. site. Superinfections. Gonorrhoea: Single dose of 400mg. Urethritis/ Anticoagulants, allopurinol, oral contraceptives. Haematological and hepatobiliary reactions (rare). cervicitis: 400mg daily in single or divided doses. A Mucocutaneous candidiasis, diarrhoea, Neutropenia: 400-800mg daily for up to 2 months. nausea, vomiting. BIOFLOXCIN Niche Skin and soft tissue: 400mg twice a day. Renal impairment: See SPC. Up to 400mg may be given 2NO AVELOX Bayer Schering as single dose, preferably in the morning. 4-quinolone. Ciprofloxacin 250mg, 500mg. White Q Contraindicated. 2NO round/oval (respect.) film-ctd scored tab. 250mgD Children or adolescents before Quinolone antibacterial. Moxifloxacin (HCl) 10, A5.21; 20, A10.47; 500mg-10, A9.73; 20, epiphyseal closures. Pregnancy, lactation. History 400mg. Dull red film-ctd tab. marked M400 one A19.48. of quinolone-induced tendon disorder. side and Bayer on reverse. 5, A16.07. S Infections caused by sensitive bacteria B Not recommended as 1st-line therapy S Respiratory infections: Acute such as gonorrhoea, RTIs, UTIs, GI infections. for pneumococcal pneumonia. Defects in G-6-PD exacerbation of chronic bronchitis (AECB). P 100-750mg twice daily, swallowed activity. Avoid strong sunlight and UV rays. Renal Community-acquired pneumonia (CAP), except whole with liquid, for 5-10 days. Determined by severe cases. Acute bacterial sinusitis. severity and infection type. Continue for at least 3 or hepatic disorders, history of psychiatric disease; caution. Tendinitis or ruptured tendon may occur. P 400mg once daily. AECB, 5-10 days; CAP, days after symptoms have disappeared. Acute Driving/ operating machines. 10 days; acute sinusitis, 7 days. cystitis: 100mg or 250mg twice daily. Other UTIs: C magn./alum. containing antacids, Q Children and growing adolescents, 250-500mg twice daily. RTIs: 250-750mg twice sucralfate or iron preparations (2 hrs apart). contraindicated. daily. Pneumococcal pneumonia: 750mg twice Caution: Hypotensive agents, anticoagulants, 2NO daily; not recommended as first-line treatment. drugs lowering seizure threshold (e.g. ALSO AVELOX IV Moxifloxacin 400mg. 250ml Cystic fibrosis lower RTIs: 750mg twice daily. theophylline), glibenclamide, phenylpropionic acid bottle. 5, A154.36. Gonorrhoea: single dose of 250mg. GI infections: S Community-acquired pneumonia. 500-750mg twice daily. Inhalation anthrax: 500mg derived NSAIDs. A Allergic reactions. Occasional CNS Complicated skin and skin structure infections in twice daily. Severe renal impairment (ccQ20ml/ disturbances. patients requiring initial parenteral therapy. min): Half total daily dose. P 400mg once daily by inf. over 60 min; Q Cystic fibrosis: (aged 5-17 years) with BRAMITOB Chiesi may be followed by oral tab. admin. CAP, 7-14 acute pulmonary exacerbation associated with P. 2NT days; skin infection, 7-21 days. aeruginosa infection, 20mg/kg twice daily (max. Q Children and growing adolescents, 1500mg) for 10-14 days. Inhalation anthrax: 15mg/ Aminoglycoside antibiotic. Tobramycin 300mg/4ml. Nebuliser solution in single-dose container. Price contraindicated. kg twice daily (max. 1000mg) for 60 days. Other on request. D History of tendon disease related to indications, only if benefit outweighs risk. quinolone treatment. QT prolongation, electrolyte D Children and adolescents unless S Chronic pulmonary infection due to disturbances particularly hypokalaemia, Pseudomonas aeruginosa in patients with cystic epiphyseal closures of long bones have occurred. bradycardia, HF, history of symptomatic fibrosis. Pregnancy, lactation.
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2
5
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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
ANTIBACTERIAL DRUGS 8.1
125-250mg twice daily; acute otitis media: 250mg twice daily. Under 5 years, oral suspension advised. 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 BY-MYCIN Ergha pyelonephritis, gonorrhoea and uncomplicated Aminoglycoside. Gentamicin (as sulph.) 10mg/ml. 2NO gonococcal urethritis. Skin and soft tissue 2ml vial. 5, A3.99. Tetracycline. Doxycycline (hyclate) 100mg. Opaque infections. S Serious systemic infections (UTIs, chest dark blue/white cap. 8, A3.12. P 100-200mg twice daily taken during or infections, bacteraemia, septicaemia, severe S Infections due to doxycycline-sensitive immediately after meals. neonatal infections). micro-organisms (pneumonia, respiratory, GI tract, Q Use paediatric suspension. Q Up to 2 weeks, 3mg/kg twelve hourly; soft tissue, ophthalmic, UTI). STDs incl. acute over 2 weeks, 2mg/kg eight hourly. 2NO gonococcal infections. D Pregnancy. ALSO CEFODOX PAEDIATRIC SUSPENSION P Usually 200mg with food or fluid on the Cefpodoxime proxetil 52mg (equiv. cefpodoxime B Caution: Existent ear disease, previous first day then 100-200mg daily. STDs, see SPC. aminoglycosides use. Renal impairment: Monitor 40mg) per 5ml. Banana flavoured granules to Q Not recommended. renal, auditory and vestibular function. prepare susp. 100ml, A11.58. D Pregnancy, lactation. Obstructive S Lower respiratory tract infections. Acute C Contra: Other nephrotoxic or ototoxic oesophageal disorders. otitis media, sinusitis. Other upper respirtory tract drug substances. Caution: Curare muscle relaxants, B Hepatic impairment. Oesophageal reflux infections incl. tonsillitis and pharyngitis where anaesthetics. Cephalosporins, loop diuretics, disorders. Take with plenty of water and remain penicillins, neomycin, kanamycin, amphotericin, infection is recurrent or chronic or caused by upright. Prolonged use. organisms resistant to commonly used antibiotics. cyclosporin, cisplatin, oral anticoagulants. C Penicillin (avoid), methoxyflurane (fatal Q Under 6 months, 8mg/kg daily in 2 A Ototoxicity and nephrotoxicity. renal toxicity). Antacids, Ca++, iron, coumarin divided doses (not recommended for infants under anticoagulants, barbiturates, carbamazepine, CIFLOXAGER Gerard 15 days); 6 months-2 years, 5ml twice daily; 3-8 phenytoin. years, 10ml twice daily; over 9 years, 12.5ml susp. 2NO A Tooth discolouration, enamel or 1 tab. twice daily. 4-quinolone. Ciprofloxacin (HCl) 250mg, 500mg. hypoplasia, GI disturbances, oesophagitis, allergic B Pregnancy. White, biconvex cap-shaped, film-ctd tab. marked reactions, photosensitivity, superinfections. 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; CALVEPEN Clonmel Pseudomembranous colitis. Headache, dizziness. 250mg-20, A10.84; 500mg-10, A10.51; 500mg-20, Rash, pruritus, urticaria. Thrombocytopenia, 2NO A21.04. leukopenia, eosinophilia. Penicillinase sensitive penicillin. Penicillin V Ca++ S Infections of the respiratory, GI and 333mg. White oval film-ctd tab. coded 105 one urinary tract incl. urethral, rectal and pharyngeal CEFTAL Rowex side, marked with lion symbol on reverse. 100, gonorrhea caused by sensitive bacteria. A7.80. 2NO P 100-750mg twice daily swallowed whole S Penicillin sensitive infections. Cephalosporin. Cefuroxime 125mg, 250mg, 500mg with liquid, depending on severity and type of Prophylactic management of patients with (equiv. cefuroxime axetil 150.36mg, 300.72mg, infection (see SPC). Duration 5-10 days (acute rheumatic fever. 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 tabs. 250 and 500mg scored on both sides. 125mg- symptoms have disappeared. doses before meals. 14, A5.25; 250mg-14, A9.44; 500mg-14, A17.94. Q Children and growing adolescents, not Q Over 6 years, 500-1000mg daily in three S Upper RTIs, bronchitis (acute and recommended. If benefit outweighs risk, 7.5-15mg/ or four divided doses before meals. (Use Calvepen exacerbations); skin and soft tissue infections; kg/day depending on severity in 2 divided doses. 333 tabs. or Calvepen 250 susp. as appropriate). uncomplicated lower UTIs and gonorrhoea; early D History of quinolone-induced tendon Aged 1-6 years, 250-500mg daily in three to four stage Lyme disease and prevention of late disorder. Children/growing adolescents unless divided doses before meals. Aged under 1 year, complications (q12 years). epiphyseal closures of long bones have occurred. 125-250mg daily in three to four divided doses P Upper RTIs: 250mg (-500mg) twice daily Pregnancy, lactation. before meals. swallowed whole shortly after meal. Lower RTIs: B CNS disorders (eg. epilepsy, history of 2NO 500mg twice daily. Lower UTIs: 125mg-250mg convulsive disease), defects in G6PD activity, renal ALSO CALVEPEN 250 SUSPENSION Penicillin V twice daily. Skin and soft tissue infections: 250or hepatic disorders, severe dehydration. Not A Ca++ 250mg/5ml. 100ml, 2.84. 500mg twice daily. Early Lyme disease: 500mg recommended as 1st-line therapy for twice daily during 20 days. Gonorrhoea: Single P 20-40ml daily in three to four divided pneumococcal pneumonia. Patients should be well 1000mg dose; 1000mg probenecid orally may be doses. before meals. hydrated. Tendon inflammation/rupture added. Duration usually 5-10 days. Q Over 6 years, 10-20ml daily in divided (discontinue). Q Over 12 years, as per adults. 5-12 years, C Drugs containing magn., alum., Ca++ or doses. 1-6 years, 5-10ml daily in divided doses. 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.
Under 1 year, 2.5-5ml in divided doses.
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
191
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
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 CIFOX Rowex 24 hours. Q CF: 20mg/kg twice daily with max. 2NO 750mg per dose for 10-14 days. Complicated UTIs 4-quinolone. Ciprofloxacin (HCl) 250mg, 500mg, and pyelonephritis: 10-20mg/kg twice daily with 750mg. White, round, scored, film-ctd tab. max. 750mg per dose for 10-21 days. Anthrax: 10embossed with cip 250 or white, oblong, scored, 15mg/kg twice daily with max. 500mg per dose for film-ctd tab. embossed with cip 500 or cip 750 resp. 250mg-10, A5.69; 250mg-20, A11.39; 500mg- 60 days. Other severe infections: 20mg/kg twice 10, A10.60; 500mg-20, A21.20; 750mg-10, A18.31. daily with max. 750mg per dose. D History of quinolone-induced tendon S Infections of the respiratory, GI and disorder (unless clearly necessary). Pregnancy, urinary tract incl. urethral, rectal and pharyngeal gonorrhea caused by sensitive bacteria. Inhalation lactation. B Children and growing adolescents (only anthrax. Acute pulmonary exacerbation of cystic if benefit outweighs risk due to risk of fibrosis associated with P. aeruginosa infection in arthropathy). Discontinue if: Severe and persistent paediatric patients aged 5-17 years. P 100-750mg twice daily swallowed whole diarrhea, tendinitis and tendon rupture, seizures, polyneuropathy, hepatic necrosis/ failure. Patients with liquid, depending on severity and type of infection (see SPC). Continue for min. 3 days after at risk for torsades de pointes arrhythmia. Hydrate well and avoid excessive alkalinity of the urine symptoms have disappeared. Gonorrhoea: 250mg (risk of crystalluria). G6PD deficiency (avoid). Avoid single dose. prolonged exposure to sunlight or UV radiation. Q Children and growing adolescents, Driving/using machines. generally not recommended. Paediatric cystic C Contra: Tizanidine. Avoid methotrexate. fibrosis: 20mg/kg twice daily for 10-14 days; Dairy products, multivalent cation-containing maximum daily dose: 1500mg. Inhalation of ++ anthrax: 15mg/kg twice daily (max. 1000mg daily) drugs and mineral suppls (eg. Ca , magn., alum., iron), polymeric phosphate binders (eg. for 60 days. sevelamer), sucralfate or antacids, highly buffered D History of quinolone-induced tendon drugs (eg. didanosine); administer ciprofloxacin 1disorder. Children and growing adolescents unless 2 hours before of 4 hours after. Caution: CYP1A2 epiphyseal closures of long bones have occurred. substrates (eg. theophylline, clozapine, ropinirole), Pregnancy, lactation. probenecid, caffeine, pentoxifylline, phenytoin, B CNS disorders (eg. epilepsy, history of oral anticoagulants, clozapine. convulsive disease), defects in G6PD activity, renal A Nausea, diarrhoea. or hepatic disorders, severe dehydration. Not recommended as 1st-line therapy for CIPROFLOXACIN TEVA Teva pneumococcal pneumonia. Crystalluria has been 2NO reported. Patients should be well hydrated. 4-quinolone. Ciprofloxacin 250mg, 500mg. White, Tendon inflammation and rupture (discontinue). film-ctd tabs, marked CIP 250 or CIP500 and Risk of pseudomembranous colitis, discontinue if breakline. 250mg round biconvex; 500mg capssuspected. Avoid direct exposure to excessive shaped. 250mg-10, A5.08; 250mg-20, A10.17; sunlight or UV-light. Abnormal lab. findings. 500mg-10, A9.46; 500mg-20, A18.94. Driving or operating machinery. S Gram(-) infections includ. RTI, UTI (acute C Contra: Tizanidine. Caution: uncomplicated cystitis, pyelonephritis), acute, Theophylline, phenytoin, anticoagulants, NSAIDs, uncomplicated gonorrhoea, prostatitis, severe cyclosporin, glibenclamide, methothrexate, probenecid, metoclopramide, omeprazole. Cationic bacterial enteritis, skin and soft tissue infections, osteomyelitis, severe systemic infections (eg. drugs, mineral suppl., sucralfate, antacids, highly septicaemia, peritonitis). Children: Acute buffered drugs (wait 4 hours); avoid concurrent pulmonary exacerbation of cystic fibrosis (CF) admin. of dairy or Ca++ fortified products. associated with P. aeruginosa infection. A Nausea, diarrhoea, rash. P 100-750mg twice daily. Dosage CIPLOX Actavis determined by severity and type of infection, sensitivity of causative organism and age, weight, 2NO renal function of the patient (see SPC). Should be 4-quinolone. Ciprofloxacin (as HCl) 250mg, 500mg, continued for at least 3 days after body 750mg. White or yellowish, biconvex, scored film- temperature returned to normal. Usual duration 3ctd tab. marked C followed by strength. Can be 14 days. Up to 28 days for prostatitis and 4-6 divided into equal halves. 250mg-10, A5.26; weeks or longer for osteomyelitis. 250mg-20, A10.39; 500mg-10, A9.93; 500mg-20, Q 5-17 years: CF: 20mg/kg twice daily for A19.87; 750mg-10, A17.35. 10-14 days; max. 1500mg daily. Other indications: S Upper and lower RTIs. UTIs. GI/intraContraindicated. D History of quinolone-related tendon abdominal infections. Genital tract infections disorder. Pregnancy, lactation. Children under 5 including gonococcal uretritis and cervicitis. years. Infections of the skin, soft tissue, bones, joints. B CNS disorders incl. epilepsy, myasthenia Treatment and prophylaxis of infections in gravis, patients at risk for torsade de pointes neutropenic patients. Prophylaxis of invasive arrhythmia. Crystalluria reported (patients should infections due to Neisseria meningitides. Inhalation anthrax (post-exposure prophylaxis and be well hydrated). Risk of pseudomembranous colitis (discontinue). G6PD deficiency. Significant curative treatment).
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.
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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.
CIPROXIN
Bayer Schering
2NO 4-quinolone. Ciprofloxacin 250mg, 500mg, 750mg. White film-ctd tabs. marked with Bayer cross and CIP 250 on reverse or marked with Bayer and CIP 500 or CIP 750 on reverse. 250mg-10, A5.65; 20, A11.31; 100, A56.54; 500mg-10, A10.52; 20, A21.05; 100, A105.24; 750mg-10, A22.93. S Infections of the respiratory, gastrointestinal and urinary tract. Gonorrhoea, inhalation anthrax. Acute pulmonary exacerbation of cystic fibrosis associated with P. aeruginosa infection in paediatric patients (5-17 years). P 100-750mg twice daily. Gonorrhoea, single dose of 250mg. Upper and lower RTIs, 250750mg twice daily. Pneumococcal pneumonia infections (second-line), 750mg twice daily. Cystic fibrosis pseudomonal lower RTIs, 750mg twice daily. Other infections, 500-750mg twice daily. Severe infections, 750mg twice daily. Upper and lower UTIs 250-500mg twice daily. Acute uncomplicated cystitis, 100-250mg twice daily for 3 days. Other acute infections, duration 5 to 10 days; continue at least 3 days after symptom remission. Inhalation anthrax, 500mg twice daily for 60 days. Renal impairment: moderate, max. 1000mg daily; severe, max. 500mg daily. R Dose as low as possible. Q Cystic fibrosis (5-17 years), 20mg/kg orally twice daily for 10 to 14 days; max. 1500mg daily. Eradication of infection due to Pseudomonas only occurs in minority of cases. Inhalation anthrax, 15mg/kg orally twice daily for 60 days; max. 1000mg daily. Other indications, not recommended in paediatric patients unless benefit outweighs risk.
2N ALSO CIPROXIN INFUSION Ciprofloxacin (as lactate) 2mg/ml. Soln. for inf. in bottle. 100ml, A27.84; 200ml, A31.35. P 100-400mg twice daily. 400mg three times daily for severe life threatening infections. Admin. 400mg dose over 60 mins., other doses 3060 mins. Duration usually 5 to 7 days; continue at least 3 days after symptom remission. Upper and 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
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 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 CLAFORAN sanofi-aventis quinidine or disopyramide, oral midazolam. Caution: CYP3A4 inducers, drugs with potential to 2N prolong QT, HMG-CoA reductase inhibitors Cephalosporin. Cefotaxime (as Na+ salt) 500mg, (simvastatin, atorvastatin or cerivastatin), IV 1g, 2g. Powder in vials. Price on application. S Septicaemia, respiratory tract infections. midazolam and other benzodiazepines metabolised by CYP3A4 (incl. triazolam and Meningitis. Soft tissue infections. UTI. alprazolam), cyclosporine, tacrolimus, sirolimus, P 1g IV or IM every 12 hours; serious digoxin, warfarin, carbamazepine, theophylline, infections, 3-6g daily in three or four divided zidovudine, rifabutin. doses; max. 12g daily. Use 2g by IV route. A Oral monilia, headache, smell alteration, Q Neonates, 50mg/kg daily; others, 100150mg/kg daily. Both in two to four divided doses; GI disorders, elevated blood urea nitrogen. max. 200mg/kg daily. CLARYL Pinewood B Penicillin sensitivity. Severe renal failure. 2NO Pregnancy, lactation. Macrolide. Clarithromycin 250mg, 500mg. Yellow, C Loop diuretics, aminoglycosides. oval, biconvex, film-ctd tab marked 250 or 500 on A Pain at inj. site, hypersensitivity reactions. GI disturbances, candidiasis, eosinophilia, one side and CL on the other. 250mg-14, A10.67; 500mg-14, A18.15. neutropenia, leucopenia, thrombocytopenia, rise in liver enzymes and blood urea. Positive Coomb’s S Lower and upper respiratory tract infections, skin and soft tissue infections and test. disseminated or localised mycobacterial infections due to Mycobacterium avium/intracellulare. CLARITHROMYCIN RANBAXY Ranbaxy Localised infections due to Mycobacterium chelonae/fortuitum/kansasii. The prevention of 2NO disseminated Mycobacterium avium complex Macrolide. Clarithromycin 250mg, 500mg. Light (MAC) infection in HIV - infected patients with yellow, oval shaped biconvex film-ctd tab., CD4 lymphocyte counts R 100/mm3. Eradication of embossed with C1 one side (250mg) or embossed Helicobacter pylori (Hp) in the presence of acid with C and 2 on either side of a breakline one suppression resulting in decreased recurrence of side and notched both sides (500mg). 500mg tab. duodenal ulcer. can be divided into equal halves. 250mg-14, P 250mg twice daily; if severe can be A9.10; 500mg-14, A15.22. increased to 500mg twice daily. Duration: 6-14 S Lower RTIs: Acute and chronic days. Mycobacterial infections: 500mg twice daily bronchitis, and pneumonia; upper RTIs: Sinusitis (with other antimycobacterial agents); increased to and pharyngitis; skin and soft tissue infections of 1000mg twice daily after 3-4 weeks if necessary. mild to moderate severity. Eradication of H. pylori MAC prophylaxis: 500mg twice daily. Hp eradication: 500mg twice daily for 7-10 days as in patients with duodenal ulcers in appropriate part of triple therapy or 500mg three times daily combination with antibacterial therapeutic for 14 days as part of dual therapy, see SPC. regimens and omeprazole or lansoprazole. Severe renal impairment: Half dose if necessary; P RTIs /skin and soft tissue infections: 250mg twice daily for 7 days. May be increased to max treatment 14 days. B Hepatic and renal impairment. 500mg twice daily for up to 14 days in severe infections. H. pylori eradication, 500mg twice daily Prolonged use may cause super-infection.
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. Tendon inflammation and rupture especially in elderly or concurrent treatment with corticosteroids. Avoid direct exposure to excessive sunlight or UV-light. Abnormal lab. findings. Na+ intake of medical concern (900mg/100ml). Driving or operating machinery. C Contra: Tizanidine. Theophylline (potentially life-threatening, monitor plasma levels). CYP450 1A2 inhibitors, phenytoin, anticoagulants, NSAIDs, glibenclamide, cyclosporin, probenecid, methothrexate, omeprazole. For tab. only: Cationic drugs, polymeric phosphate binders, mineral suppl., sucralfate, antacids, highly buffered drugs (wait 4 hours); avoid concurrent admin. of dairy or Ca++ fortified products. A Nausea, diarrhoea. Inj./inf. site reactions.
ANTIBACTERIAL DRUGS 8.1 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.
CLAVAMEL FORTE
Clonmel
2NO b-lactamase inhibitor/broad spectrum penicillin. Clavulanic acid (as K+ salt) 125mg, amoxicillin (as trihydrate) 500mg. Yellow oblong tab. marked 625. 14, A7.29. S Infections of the respiratory tract, ENT, UTI, skin and soft tissue. P 1 three times daily. Q Over 12 years, same as adults; under 12 years, use susp.
2NO ALSO CLAVAMEL TABLETS Clavulanic acid (as K+ salt) 125mg, amoxicillin (as trihydrate) 250mg. White oval film-ctd tab. 21, A5.90; 100, A28.11. P 1-2 three times daily. Q Over 12 years, same as adults; under 12 years, use susp.
2NO ALSO CLAVAMEL PAEDIATRIC SUSPENSION Clavulanic acid (as K+ salt) 31mg, amoxicillin (as trihydrate) 125mg per 5ml. Powder for susp. Powder for 100ml, A3.71. Q Under 3 months, not recommended; 3-9 months, 2.5ml HALF-STRENGTH paed. susp. three times daily; 9 months-2 years, 5ml HALF-STRENGTH paed. susp. three times daily (or 2.5ml FULL STRENGTH paed. susp.); 2-6 years 5ml FULL STRENGTH paed. susp. three times daily (or 2.5ml FULL-STRENGTH paed. susp. three times daily). In severe infections doses may be doubled. D Hypersensitivity to penicillin or cephalosporins, previous history of co-amoxiclavassociated jaundice/hepatic dysfunction. B Liver or renal dysfunction. Infectious mononucleosis, lymphatic leukaemia, use in severe GI complaints, severe allergies or asthma. Pregnancy, lactation. A Diarrhoea, indigestion, nausea, vomiting, candidiasis. Urticarial and erythematous rashes, transient leucopenia, anaemia. Rarely 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
193
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
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 CLONAMP Clonmel tooth and tongue discoloration, taste perversion, GI disorders, oral monilia, elevated BUN. 2NO Broad spectrum penicillin. Ampicillin 250mg, Rowex 500mg. Grey/red caps. marked CLONAMP. 250mg- CLOROM 2NO 100, A6.12; 500mg-100, A11.16. 2NO Macrolide. Clarithromycin 250mg, 500mg. White, ALSO CLONAMP SYRUP Ampicillin 125mg, 250mg/ oblong, convex, film-ctd tab. scored on both faces. 70ml-125mg/5ml, A4.39; 70ml- 250mg/5ml, A8.77. 5ml. 125mg-Powder to prepare 100ml, A0.80; S Lower and upper RTIs, skin and soft 250mg-Powder to prepare 100ml, A1.46. tissue infections of mild to moderate severity. S Respiratory, urinary tract and other Eradication of H. pylori (Hp) in patients with Hp Gram-positive and Gram-negative infections. associated ulcers in combination with appropriate P 250-500mg six hourly. antibacterial and ulcer healing agents. Q Half adult dose. P 250mg twice daily during 7-14 days. In B Infectious mononucleosis. severe infections, can be increased to 500mg twice C Oral contraceptives. daily. Streptococcus pyogenes infections, duration A Hypersensitivity reactions. GI min. 10 days. Continue therapy min. for 2 days disturbances. after symptoms subsided. Hp eradication: 500mg CLONOCID Clonmel twice daily in combination with amoxicillin 1000mg twice daily and omeprazole 20mg twice 2NO daily during 7 days. Macrolide. Clarithromycin 250mg, 500mg. Light Q 12 years and under with weight Q30kg, yellow, oval, biconvex, film-ctd tabs. 250mg not suitable. marked C1; 500mg marked C and 2 on either side 2NO of breakline. 250mg-14, A9.31; 500mg-14, A18.57. S Infections of upper or lower respiratory ALSO CLOROM SUSPENSION Clarithromycin 125mg/5ml, 250mg/5ml. White granules for oral tract, skin and soft tissue infections of mild to susp. 70ml-125mg/5ml, A4.39; 70ml- 250mg/5ml, moderate severity where penicillin is A8.77. inappropriate. In combination with appropriate S Infections in children including lower agents for the eradication of H. pylori (Hp) in and upper RTIs, skin and soft tissue infections of patients with Hp associated ulcers. P 250mg twice daily for 6-14 days; may be mild to moderate severity. Acute otitis media. Q 1-12 years: Oral susp. only, approx. increased to 500mg twice daily in severe 7.5mg/kg (i.e. 8-11kg: 62.5mg; 12-19kg: 125mg; 20infections. Continue at least for 2 days after symptoms have subsided. Streptococcus pyogenes 29kg: 187.5mg; 30-40kg: 250mg) twice daily, 12 hours apart, for 5-10 days. infections, duration at least 10 days. Hp eradication: 500mg twice daily when given as part D Hypersensitivity to other macrolides, of 1st line triple therapy. Severe renal impairment: lincosamide and azalide antibacterial agents. Severe hepatic/renal impairment. Hypokalemic Half dose; max. 14 days. Q 12 years or younger less than 30kg, not patients (risk of prolongation of QT-time). B Hepatic and renal impairment. suitable. Pseudomembranous colitis reported. Prolonged 2NO use may cause superinfection.Due to a risk of ALSO CLONOCID SUSPENSION. Clarithromycin increased QT-interval, caution with coronary vessel 250mg per 5ml. Granules for oral susp. 250mgdisease, history of ventricular arrhythmia, severe 70ml, A8.49. cardiac insufficiency, hypomagnesemia, S Streptococcal tonsillitis, otitis media, skin and soft tissue infections of mild to moderate bradycardia (Q 50 bpm). Do not use in patients with congenital or acquired QT prolongation. May severity where penicillin is inappropriate. Q 6 months or older, 7.5 mg/kg twice daily cause exacerbation or aggravation of myasthenia gravis. Pregnancy (unless clearly necessary), for 6-14 days. 125mg dosage : 1-2 years/8-11kg: lactation. Tab. contains lactose. Susp. contains: 2.5mlx2; 2-4 years/12-19kg: 5mlx2; 4-8 years/2029kg: 7.5mlx2; 8-12 years/30-40kg: 10mlx2. 250mg Sucrose, aspartame. C Contra: Ergot vasoconstrictors, cisapride, dosage : 2-12 years, half 125mg dosage. Severe pimozide and terfenadine; substrates of CYP3A4 renal impairment: Half dose up to 14 days. (unless clearly indicated). Caution: Astemizole and D Hypokalemic patients. other macrolides, quinidine, disopyramid, drugs B Impaired hepatic function; with potential to prolong QT, cyclosporin, hypersensitivity to other macrolides, clindamycin and lincomycin; coronary vessel disease, history of tacrolimus, sirolimus, digoxin, theophylline, ventricular arrhythmia, severe cardiac insufficiency, warfarin, zidovudine, inducers / strong inhibitors of CYP3A4. HMG Co-A reductase inhibitors. non-compensated hypokalemia and/or hypomagnesemia, bradycardia; Myasthenia gravis. A Oral monilia, headache, smell alteration, GI disorders. Elevated BUN. Pseudomembranous colitis, superinfections with tissue infections. P 250mg three times daily. Q Half adult dose. B Infectious mononucleosis. A Hypersensitivity reactions. GI disturbances.
surgery, burns and wounds. Aerosol therapy. P (Over 60 kg): 2 mega units eight hourly. Q 50,000 units/kg daily in three divided doses.
2NO ALSO COLOMYCIN TABLETS Colistin sulph. 1.5 mega units. White quarter scored tab. marked with P in a hexagon. 50, A87.00.
2NO ALSO COLOMYCIN SYRUP Colistin sulph. 0.25 mega units/5ml. Powder to prepare 80ml, A5.18. S Gram-negative GI infections, preoperative bowel preparations. P 1-2 tabs. eight hourly. Q Up to 15 kg, 5-10ml; 15-30kg, 15-30ml; over 30 kg, same as adult. All eight hourly. D Pregnancy, lactation. B Renal dysfunction, shock, superinfections. C Caution: Cuaraniform muscle relaxants, antibiotics. A Perioral parasthesia, vertigo.
CRYSTAPEN
Britannia
2NO Penicillinase-sensitive penicillin. Penicillin G Na+ 600mg (1 mega). Unbuffered powder in vial. 1, A0.51. S Infections of skin, soft tissue, respiratory tract, ENT. P 600-1200mg IM or IV daily in two or four divided doses. Q Newborn infants, 50mg/kg/day in 2 divided doses; Infants 1-4 weeks, 75mg/kg/day in 3 divided doses; 1 month-12 years, 100mg/kg in 4 divided doses; max. 4g/day B See SPC. A Hypersensitivity reactions. GI disturbances.
CUBICIN
Novartis
2N
Antibacterial. Daptomycin 350mg, 500mg. Powder for conc sol for inf, in vial. 350-mg-1, A79.56; 500mg-1, A118.57. S Complicated skin and soft-tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to S. aureus, S. aureus bacteraemia (SAB) when associated with RIE or cSSTI. P cSSTI without concurrent SAB: 4mg/kg admin once every 24 hrs for 7-14 days or until infection is resolved. cSSTI with concurrent SAB: 6mg/kg admin once every 24 hrs. Known or suspected S. aureus RIE: 6mg/kg admin once every 24 hrs. Renal insufficiency: See SPC for dose adjustment. Q Under 18 years, not recommended. D Pregnancy (unless clearly necessary), lactation. B If S. aureus infection focus other than 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 insusceptible organisms (discontinue if occurs). pains and/or weakness and myositis, COLOMYCIN Forest Pregnancy and lactation (only if benefit outweighs myoglobinaemia and rhabdomyolysis; monitor 2 N O risk). Suspension contains sucrose and source of plasma CPK at least once weekly, or more often Polymyxin. Colistin sulphomethate Na+ 1 mega phenylalanine. (CPK q5x ULN, severe renal impairment, unit. Powder in vials. 1 mega unit-10, A25.04. C Ergot derivatives, cisapride, pimozide, concurrent medications associated with S Gram -ve systemic and ENT infections, terfenadine, simvastatin or atorvastatin (all myopathy); if symptoms occur, monitor CPK every
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d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
ANTI-INFECTIVES
ANTIBACTERIAL DRUGS 8.1
2 days; discontinue if CPK q5x ULN with unexplained muscle symptoms. If peripheral neuropathy symptoms occur, consider discontinuation. Renal insuffiency: Caution, adjust dosage. May occur: Superinfection, antibioticassociated colitis and pseudomembranous colitis. C Discontinue medications associated with myopathy; if cannot avoid, monitor for myopathy symptoms and monitor CPK more than once weekly. Caution: Medicinal products reducing renal filtration (e.g. NSAIDs, COX-2 inhibitors). May cause apparent prolongation in Prothrombin Time/International Normalised Ratio assays. A Fungal infections, headache, nausea, vomiting, diarrhoea, rash, infusion site reactions, abnormal liver function tests, increased CPK.
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 DALACIN C Pharmacia disturbances. Fever. Vaginal moniliasis, vaginitis, genital pruritus. Haematological changes, 2NO abnormal urinalysis. Transient increase in BUN or Lincosamide. Clindamycin (HCl) 150mg. Hard gel creatinine. Nervousness, insomnia, dizziness, cap. with opaque lavender body and opaque somnolence. maroon cap, marked ’P & U 225’. 150mg-24, A13.10; 100, A52.59. ERYTHROCIN Amdipharm S Serious clindamycin-sensitive infections. 2NO P 150-450mg six hourly. Q Over 1 month: 12-24mg/kg daily in 4 Macrolide. Erythromycin stearate 250mg, 500mg. divided doses. Under 1 year of age or weighing White oblong film-ctd tabs. with maker’s symbol. R10kg: Min 37.5mg 8 hourly. 250mg-100, A14.00; 500, A68.20; 500mg-100, A28.12. 2NO S Erythromycin-sensitive infections. ALSO DALACIN C PHOSPHATE Clindamycin (phosphate) 150mg/ml. Soln for inf or inj. 5 x 2ml, P 1-2g daily in divided doses. Max 4g daily in severe infections. A29.61; 5 x 4ml, A58.96. Q Mild to moderate infections: 30mg/kg/ P 600mg-2.7g by IM or IV inj. daily in day in divided doses. For severe infections, up to divided doses. 50mg/kg/day in divided doses. Q Over 1 month, 15-40mg/kg daily in 2NO divided doses. D Lincomycin sensitivity. ALSO ERYTHROCINE IV LACTOBIONATE B Discontinue use if persistent diarrhoea Erythromycin (as lactobionate) 1g. Powder in vial. or colitis appear. Renal or hepatic impairment. 1, A9.85. C Neuromuscular blocking agents. V Severe and immunocompromised A GI disturbances incl. pseudomembranous infections: 50mg/kg/day, preferably by continuous colitis. Jaundice and blood disorders. inf., (equiv. 4g/day for adults). Mild to moderate infections (oral route compromised): 25mg/kg/day. DISTACLOR LA Clonmel D Serious hepatic impairment. Lactation, pregnancy (unless essential). 2NO B Liver impairment. Hypertrophic pyloric Cephalosporin. Cefaclor 375mg. Sust-release blue stenosis reported in infants. A tab. marked TA422O and LILLY. 14, 7.48. C Contra: Terfenadine, astemizole, 2NO cisapride, pimozide, ergotamine and ALSO DISTACLOR LA FORTE Cefaclor 500mg. Blue, dihydroergotamine. Caution: Theophylline, capsule-shaped, film coated, prolonged-released digoxin, oral anticoagulants, lovastatin, tablets. 28, A10.84. simvastatin, triazolobenzodiazepines, colchicine, S Acute bronchitis, pharyngitis and CYP 3A4 substrates. tonsillitis, pneumonia, lower UTI, skin and skin A Gl disturbances. Allergic reactions. structure infections. Adjust antimicrobial therapy according to causative organism. ERYTHROPED SF Amdipharm P Pharyngitis, tonsillitis, skin and skin structure infections: 375mg twice daily. Lower UTI: 2 N O 375mg twice daily or 500mg once daily. Bronchitis: Macrolide. Erythromycin (as ethyl succinate) 375mg or 500mg twice daily. Pneumonia: 750 mg 250mg/5ml. Sugar-free susp. Granules for 140ml20, A7.32. twice daily. Infections caused by S. pyogenes, admin. for at least 10 days. Dose safety of 4g/day 2 N O demonstrated for 28 days. Haemodialysis: Loading ALSO ERYTHROPED PI SF Erythromycin (as ethyl dose of 250 to 1000mg prior to dialysis and 250 to succinate) 125mg/5ml. Sugar-free susp. Granules 500mg every 6 to 8h between dialyses. Absorption for 140ml-20, A3.76. S Prophylaxis and treatment of enhanced with food. erythromycin sensitive infections. Q Not recommended.
2NO
2NO
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;
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.
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
sanofi-aventis
2MO Nitromidazole. Antibacterial. Metronidazole 200mg. Off-white film-ctd tab. and off-white cap.shaped film-ctd tab. Both marked with name and strength. 200mg-21, A1.66; 250, A19.65; 400mg14, A2.35; 100, A16.75.
2MO ALSO FLAGYL-S ORAL SUSPENSION Metronidazole benzoate 200mg/5ml. Susp. 100ml, A6.17. S Prevention and treatment of infections due to anaerobic bacteria (esp. bacteroides sp, anaerobic streptococci, fusobacteria, clostridia). Chronic pressure sores and ulcers with possible anaerobic infection. P Anaerobic Infections: Treatment: 800mg followed by 400mg 8 hourly. Prophylaxis: 400mg 8 hourly 24 hrs pre-operatively followed by IV or rectal admin. post-operatively until oral dosing resumed. Pressure sores: 1200mg in 3 divided doses. Q Anaerobic Infections, treatment and prophylaxis: 7.5mg/kg 8 hourly.
2MO ALSO FLAGYL SUPPS Metronidazole 500mg. 500mg-10, A7.85. S Prevention and treatment of infections due to anaerobic bacteria (esp. bacteroides sp., anaerobic streptococci, fusobacteria, clostridia). P Treatment: 1g 8 hourly for 3 days, then 1g 12 hourly or switch to oral therapy. Prophylaxis: 1g 8 hourly. Q Treatment: 7.5mg/kg 8 hourly. Prophylaxis: 125-250mg 8 hourly.
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). 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
195
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
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 crossFLOXAPEN Actavis sensitisation. Driving or operating machinery. Take v-1 hr before meals or on empty stomach. 2NO Penicillinase-resistant penicillin. Flucloxacillin (Na+) Contains sodium. C Probenecid. 250mg, 500mg. Black/caramel caps. marked with A Hypersensitivity reactions. Angioedema, name and strength. 250mg-28, A4.45; 500mg-28, thrombocytopenia, neutropenia, erythema A8.89. multiforme, Stevens-Johnson syndrome, toxic 2NO epidermal necrolysis, interstitial nephritis. Minor GI ALSO FLOXAPEN SYRUP Flucloxacillin (as disturbances. magnesium salt) 125mg/5ml, 250mg/5ml. 125mg/ 5ml, powder for 100ml, A2.56. 250mg/5ml, FLUCLON Clonmel powder for 100ml, A7.88. 2NO S Skin, soft tissue, ENT and other Penicillinase-resistant penicillin. Flucloxacillin Na+ infections due to Gram-positive organisms (incl. 250mg, 500mg. Both blue/blue caps. marked with resistant staphylococci). As prophylactic agent twin triangle logo and FXN 250 or FXN 500. during major surgery. 250mg-250, A38.38. 500mg-250, A76.75. 2NO S Skin, soft tissue, ENT and other ALSO FLOXAPEN INJECTION Flucloxacillin (as Na+ infections due to Gram-positive organisms (incl. salt) 250mg, 500mg. Powder in vials. 250mg-10, resistant staphylococci). A11.02; 500mg-10, A22.05. P 250-500mg three times daily v-1 hour P 250-500mg three times daily taken before meals. orally or by IM or IV route. Osteomyelitis, Q Under 10 years, not recommended; over endocarditis: up to 8g daily in divided doses, 6-8 10 years, same as adults. hr. Surgical prophylaxis: 1g - 2g IV at start of A Hypersensitivity reactions, GI anaesthesia followed by 500mg 6hr IV, IM or orally 6 hr intervals for up to 3 days. Oral dose to disturbances. be taken v-1 hour before meals. GSK Q Over 10 years, as per adults. 2-10 years, FORTUM 2NO v adult dose; under 2 years, t adult dose. D Hypersensitivity to blactam antibiotics. Cephalosporin. Ceftazidime (as pentahydrate) History of flucloxacillin-associated jaundice/hepatic 500mg, 1g, 2g. Powder in vials. 500mg-1, A5.75; dysfunction. Ocular or subconjunctival admin. 1g-1, A11.46; 2g-1, A22.94. from Floxapen IV S Infections of the respiratory tract, ENT, B Pregnancy, lactation. Newborns. skin and soft tissues, bone and joints, biliary and Hepatic/renal impairment. Cap. and inj. contain GI tract. UTI. Septicaemia, meningitis. Infections in Na+. immunocompromised patients. C Probenecid. May affect gut flora. V See lit. A Minor GI disturbances. Hypersensitivity B Penicillin sensitivity. Impaired renal reactions. function. Pregnancy. C Aminoglycosides, loop diuretics. FLUCILLIN Pinewood A Hypersensitivity reactions, GI disturbances. See SPC. 2NO Penicillinase-resistant penicillin. Flucloxacillin Na+ LEO Pharma 250mg, 500mg. Caramel coloured body with grey FUCIDIN 2NO caps. with FXN250 and FXN500, logo on reverse. Fusidic acid salt. Sodium fusidate 250mg. White 250mg-100, A15.48; 500, A86.42; 500mg-100, A30.98; 500, A158.74. film-ctd ovoid tab. coded 121 one side, lion symbol on reverse. 100, A81.07. P 250mg, 4 times daily. Severe renal failure, reduce dose or extend dose interval. S Staphylococcal infections. Q Under 2 years, a quarter of the adult P 500mg three times daily. Severe dose. 2-10 years, half the adult dose. infections, doses may be doubled. 2NO Q Use susp. 20-50mg/kg in divided doses. 2NO ALSO FLUCILLIN SUSPENSION Flucloxacillin (as A Na+) 125mg/5ml. 100ml, 2.56. ALSO FUCIDIN SUSPENSION Fusidic acid 250mg/ S Infections due to penicillinase producing 5ml. 50ml, A9.07. staphylococci and other susceptible Gram+ P 10-15mls three times daily. organisms. Q Under 1 year, 1ml/kg daily in three P 750mg-1500mg daily in divided doses. divided doses; 1-6 years, 5ml three times daily; 6Dosage may be increased if necessary. Severe renal 12 years, 10ml three times daily. failure, reduce dose or extend dose interval. D Tabs only: Biliary tract obstruction. Q Under 2 years, not recommended; 2-12 B Perform periodic liver function tests. years, 50mg/kg BW in divided doses; over 12 years, Pregnancy (theoretical risk of kernicterus), 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.
196
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.
GERAMOX
Gerard
2NO Broad spectrum penicillin. Amoxycillin (as trihydrate) 250mg, 500mg. Red/ivory caps. marked Ax and strength also G. 250mg-15, A1.84; 50, A6.14; 500, A61.41; 500mg-15, A3.68; 100, A24.57; 500, A122.87.
GERIFLOX
Gerard
2NO Penicillinase-resistant penicillin. Flucloxacillin (Na+) 250mg, 500mg. Grey/brown caps. coded G and FN250 or G and FN500. 250mg-100, A14.46; 500mg-100, A28.92. S Infections due to penicillinase producing staphylococci and other gram-positive organisms susceptible to this anti-infective. P 250-500mg three times daily v-1 hour before meals. Q 4-12 years, 25mg/kg body weight in divided doses.
2NO ALSO GERIFLOX ELIXIR Flucloxacillin (Na+) 125mg/ 5ml. 100ml bottle of pink, pineapple flavoured granular powder for reconstitution to oral suspension. 1, A2.55. P Orally administrated v-1 hour before meals. 750mg-1500mg daily in divided doses (ie. 2 to 4 5ml teaspoons three times a day). Double if necessary. Q 2-12 years, 50mg/kg body weight in divided doses (or half adult dose). D Hypersensitivity to penicillins. Pregnancy, lactation. B Severe renal failure (reduction in dose or extension of dose intervals). Potential superinfection due to resistant organisms (prolonged use). A Skin rashes (discontinue), GI disturbances.
GERMENTIN
Gerard
2NO b-lactamase inhibitor/broad-spectrum penicillin. Amoxicillin (as trihydrate) 500mg / clavulanic acid (as K+ salt) 125mg. Oval, biconvex, off-white, filmctd tab. scored on both sides. 16, A8.55.
2NO ALSO GERMENTIN TABLETS Amoxicillin (as trihydrate) 250mg / clavulanic acid (as K+ salt) 125mg. Oblong, convex, off-white, film-ctd tab. marked AXC 375 on one side and twice G on reverse. 21, A6.13. 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
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 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).
once daily for 5 days. Q Not recommended. D History of long QT syndrome, known or aquired QT interval prolongation. Pregnancy, lactation. B Coronary heart disease, ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, bradycardia (Q50bpm). INVANZ MSD Monitor patients on pravastatin, rosuvastatin or fluvastatin for signs and symptoms of myopathy 2JN and rhabdomyolysis. b-lactam. Ertapenem 1g. Powder for soln. 1, C Contra: Simvastatin, atorvastatin, A52.94. lovastastin; strong CYP3A4 inhibitors in patients S Intra-abdominal infections, community with renal impairment. Caution: Macrolides, acquired pneumonia, acute gynaecological cisapride, ergot alkaloid derivatives, pimozide, infections and diabetic foot infections of the skin astemizole, terfenadine, rifampicin, phenytoin, and soft tissue. Prophylaxis of surgical site carbamazepine, cyclosporin, tacrolimus, serolimus, infection following elective colorectal surgery in digoxin, statins, benzodiazepines, CYP3A4 adults. P 1g once daily by IV inf. over 30 mins for inhibitors, St.John’s wort. See SPC. 3-14 days. Prophylaxis of surgical site infection: 1g A Diarrhoea, nausea, vomiting, GI pain, increased lliver enzymes, flush, palpitations, as single IV dose to be completed within 1 hour dizziness, headache, taste disturbances, blurred prior to surgical incision. vision, vaginal moniliasis, rash, pruritus. Q 13-17 years, as per adults. Under 3 months, not recommended. 3 months-12 years, Abbott 15mg/kg twice daily by IV inf. over 30 mins for 3- KLACID LA 2NO 14 days. Max 1g/day. HOSPIRA PIPERACILLIN/ D Hypersensitivty to penicillin, Macrolide. Clarithromycin 500mg. Modified release TAZOBACTAM Hospira cephalosporins, other b-lactams. Advanced renal yellow ovaloid film-ctd tab. marked with logo. 7 2N insufficiency, haemodiaylysis (no data). Lactation. (Cal/Pk), A14.16; Severe infection pack-14 (Cal/Pk), A28.32. Broad spectrum penicillin/beta-lactamase inhibitor. B May occur: Superinfection, colitis and pseudomembranous colitis, seizures (esp. elderly S Upper and lower respiratory tract Piperacillin (Na+)/ tazobactam (Na+), 2g/0.25g; 4g/ patients, pre-existing CNS disorders and/or infections. Skin and soft tissue infections. 0.5g. Powder for sln for inj. or inf. Prices on compromised renal function). Pregnancy. Contains P 1 daily. Severe infections: 2 tabs. once request. Na+. Driving/operating machines. daily for up to 7 days. S Moderate to severe systemic and/or C Not recommended: Valproic acid. Q Use paediatric susp. local bacterial infections in which betalactamase producing bacteria suspected or detected. Adults/ A GI disorders, infused vein complication, 2 N O headache, rash, pruritus, inf. site pain. Raised ALT/ Adolescents/elderly: Nosocomial pneumonia, ALSO KLACID Clarithromycin 250mg. Yellow oval AST, alkaline phosphatase and platelet count. complicated UTIs (incl. pyelonephritis), intrafilm-ctd tab. marked with logo. 14 (Cal/Pk), A9.71. abdominal infections, skin and soft tissue P 250mg twice daily. Severe infections, KEFLEX Clonmel infections, bacterial infections in neutropenic 500mg twice daily for 7 days. adults. Children (2-12 years): Bacterial infections in 2 N O Q Use paediatric susp. neutropenic children. 2NO Cephalosporin. Cephalexin monohydrate 250mg. P By slow IV injection (over at least 3-5 Dark green/white cap. coded LILLY H69. 28, A4.11; ALSO KLACID SUSPENSION Clarithromycin 250mg/ min) or slow IV infusion (over 20-30 min). Usual 5ml. Fruity-flavoured. Granules for 70ml, A8.79. 100, A14.00. dose 4g/500mg every 8 hours. Total daily dose 2NO Q Under 1 year (8kg), 0.15ml/kg; 1-2 years depends on severity and localisation of infection: (8-11kg), 1.25ml; 3-6 years (12-19kg), 2.5ml; 7-9 ALSO KEFLEX TABLETS Cephalexin monohydrate From 2g/250mg to 4g/500mg admin. every 6 or 8 years (20-29kg), 3.75ml; 10-12 years (30-40kg), 5ml. 500mg. Peach oval tab. coded LILLY U49. 21, hours. Neutropenia: 4g/500mg every 6 hours in A5.99; 100, A27.40. All twice daily. combination with an aminoglycoside. Renal 2NO 2NO insufficiency: See SPC. ALSO KLACID PAED. SUSP Clarithromycin 125mg/ ALSO KEFLEX SUSPENSION Cephalexin 125mg, Q Under 2 years, not recommended. 2-12 5ml. Fruity flavoured. Granules for 100ml, A10.22; 250mg/5ml. Powder for 100ml-125mg, A1.45; years, neutropenia: Q40 kg, adjust dose to 90mg/ A 70ml, A4.39. 250mg, 2.93. kg (80mg/10mg) every 6 hours in combination S Respiratory tract, soft tissue and skin Q Under 1 year (8kg), 0.3ml/kg; 1-2 years with an aminoglycoside, not exceeding 4g/500mg infections. UTI. Otitis media, bone and joint (8-11kg), 2.5ml; 3-6 years (12-19kg), 5ml; 7-9 years every 6 hours. Renal insufficiency: See SPC. Over infections. Dental infections. (20-29kg), 7.5ml; 10-12 years (30-40kg), 10ml. All 12 years, as per adults. P 1-4g daily in divided doses. twice daily. B Hypersensitivity reactions to penicillins, Q 25-50mg/kg daily in divided doses. 2 NO cephalosporins, other allergens; discontinue if B Hypersensitivity to penicillins. Renal ALSO KLACID IV Clarithromycin 500mg (for allergic reaction occurs. May occur: insufficiency. infusion only, should not be given as bolus or IM) Pseudomembranous colitis, leucopenia and C Loop diuretics, aminoglycosides. Vial. 1, A13.95. neutropenia (esp. prolonged therapy; periodic full A Hypersensitivity reactions. GI S Upper/lower respiratory tract infections, blood count), bleeding manifestations, disturbances, eosinophilia, neutropenia, rise in + skin and soft tissure infections where parenteral hypokalaemia (low K reserves; periodic electrolyte liver enzymes. Positive Coomb’s test. therapy is required. determinations), modest elevation of liver function P 500mg twice daily by IV infusion over indices, emergence of resistant organisms, KETEK sanofi-aventis 60 mins. using soln. concentration of 2mg/ml. neuromuscular excitability or convulsions (at 2 N O R As for adults. higher doses by IV). Prolonged therapy: Assess Ketolide antibiotic. Telithromycin 400mg. Light Q Not recommended, insufficient data. organ system functions periodically (incl. renal, orange film-ctd tab. marked H3647 one side, 400 D Serious hepatic impairment (IV only) hepatic). Increased incidence of fever and rash in on reverse. 10; A27.86. B Renal or hepatic impairment. Pregnancy, cystic fibrosis patients associated with piperacillin therapy. Not for use in children who do not have S Community acquired pneumonia, acute lactation. exacerbations of chronic bronchitis, acute sinusitis, C Theophylline, oral anticoagulants, neutropenia or complicated appendicitis. carbamazepine, digoxin, terfenadine, drugs tonsilitis/pharyngitis. Pregnancy, lactation (only if clearly indicated). metabolised by P450 (e.g.warfarin, ergot alkaloids, P Community acquired pneumonia, Contains Na+. C Caution: Probenecid, tobramycin and phenytoin, cyclosporin, tracrolimus, rifabutin). 800mg once daily for 7-10 days. Others, 800mg 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. Admin. at 8-hour intervals. Renal impairment: see SPC. D Hypersensitivity to penicillin or cephalosporins, previous history of co-amoxiclavassociated jaundice/hepatic dysfunction. B Lactation, pregnancy (increased risk of necrotising enterocolitis in neonates). Liver or renal dysfunction, severe allergies or asthma. Infectious mononucleosis, lymphatic leukaemia (not recommended). Elderly, long-term use. C Bacteriostatic chemotherapeutics/ antibiotics, disulfiram, hormonal contraceptives. Caution: Probenecid, allopurinol, digoxin, anticoagulants. A GI upset, exanthemas, pruritus, superinfections, moderate increase in liver enzymes.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
197
8.1 ANTIBACTERIAL
ANTI-INFECTIVES
DRUGS
A Nausea, vomiting, abdominal pain and diarrhoea, headache, rash, transient CNS effects, inj. site reactions, taste perversion, transient liver enzyme elevation.
alteration.
MINOX 50
KOPEN 2NO
Penicillinase sensitive penicillin. Phenoxymethyl KLARAM Actavis penicillin 250mg. White tab. marked Pen 250. 100, 2NO A4.05. Macrolide. Clarithromycin 250mg, 500mg. Yellow, 2 N O oval, biconvex film-ctd tabs marked 250 and 500 ALSO KOPEN POWDER FOR ORAL SOLUTION resp. on one side and CL on reverse. 250mg-14, Phenoxymethyl penicillin 125mg/ 5ml, 250mg/5ml. A8.81; 500mg-14, A17.63. Off-white sugar-free granular powder. 125mg/5mlS Lower and upper RTIs; skin and soft 100ml, A1.45; 250mg/5ml-100ml, A2.32. tissue infections. Disseminated or localised S Penicillin sensitive gram positive mycobacterial infections due to M. avium or infections. intracellulare; localised infections due to M. P 250-500mg every 6 hours depending on chelonae, fortuitum or kansasii. Prevention of the severity of the condition. Long term disseminated M. avium complex (MAC) infection in prophylaxis of rheumatic fever: 250mg twice daily. HIV patients with CD4 counts R100/mm3. H. pylori R Reduce dose if renal function is eradication. markedly impaired. P 250mg twice daily; can be increased to Q Oral Solution: Under 1 year, 62.5mg six 500mg twice daily if more severe. Usual duration, hourly, max. 250mg daily. 1- 5 years, 125mg six 6-14 days. Renal impairment (cc Q 30ml/min): Half hourly, max. 500mg daily. Over 5 years, as per dose for max. 14 days. Mycobacterial infections: adult. Initially 500mg twice daily. If no response in 3-4 D Penicillin hypersensitivity. Pregnancy, weeks, may be increased to 1000mg twice daily. lactation. MAC prophylaxis: 500mg twice daily. H. pylori B History of significant allergies and/or eradication: See SPC. asthma. Impaired renal function, prolonged use D Known hypersensitivity to macrolides. (may cause superinfection). Lactation. C Bacteriostatic anti-infective agents, not B Caution: Renal/hepatic impairment, recommended. Indomethacin, salicylate. possible cross resistance with other macrolides, A Skin eruptions, sensitivity reactions, lincomycin or clindamycin. Overgrowth of nonfever, eosinophilia, GI upset. susceptible bacteria (discontinue if superinfection occurs). Pregnancy. MERONEM AstraZeneca C Contra: Cisapride, pimozide, terfenadine, astemizole and other macrolides (risk 2 N Carbapenem. Meropenem 500mg, 1g. Powder in of QT prolongation), ergot derivatives. Caution: vial. 500mg, A186.65; 1g, A373.30. Theophylline, carbamazepine, P450 substrates, S Pneumonia, UTI, intra-abdominal, digoxin, zidovudine, ritonavir. gynaecological, skin and soft tissue infections, A GI disorders, headache, altered taste, meningitis, septicaemia, febrile neutropenia. transient elevations of liver enzymes. P 500mg-1g by IV bolus inj. over 5 mins or KLARIGER Gerard by IV inf. over 15-30 mins every 8 hrs. Meningitis, 2g every 8 hrs. 2NO Macrolide. Clarithromycin 250mg, 500mg. Yellow, Q Under 3 months, not recommended; oval, biconvex, film-ctd tab. marked C250 or C500 over 3 months, 10-20mg/kg by IV bolus inj. over 5 mins or by IV inf. over 15-30 mins every 8 hrs. on one side and G on reverse. 250mg-14, A9.70; Meningitis, 40mg/kg every 8 hrs. 500mg-7, A9.34. S Lower and upper RTIs and skin and soft B Hepatic impairment. Infections caused by methicillin resistant staphylococci. Pregnancy, tissue infections of mild to moderate severity. lactation. Pseudomembranous colitis has been Eradication of H. pylori in patients with Hp associated ulcers in combination with appropriate reported rarely. C Nephrotoxic drugs, probenecid. agents. A Nausea, diarrhoea, thrombocythaemia, P 250mg twice daily for 7 days; if severe vomiting, inflammation, thrombophlebitis, pain. can be increased to 500mg twice daily for up to Increased serum transaminases, bilirubin, alkaline 14 days. Hp eradication: 500mg twice daily for 7phosphatase, lactic dehydrogenase. 14 days as part of triple therapy or 500mg three times daily for 14 days as part of dual therapy. Severe renal impairment: Half dose if necessary. Q Under 12 years, not recommended. 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
198
Rowex
Athlone 2 N O
Tetracycline. Minocycline 50mg. Yellow-brown 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.
MONOTRIM
Chemidex
2NO Folic acid inhibitor. Trimethoprim 10mg/ml. Susp. 100ml, A25.31. S Trimethoprim-sensitive infections incl. UTIs, RTIs and prophylaxis of recurrent UTIs. P 200mg twice daily for 7-10 days. Prophylaxis of recurrent UTIs: 100mg at night and if necessary 100mg in the morning. Renal Impairment: See SPC. Q Based on 6mg/kg/day in two divided dosages as follows: 6 weeks to 5 months, 25mg; 6 months-3 years, 25-50mg; 4-7 years, 50-75mg; 8-12 years, 75-125mg. All twice daily for 7-10 days. Prophylaxis of recurrent UTIs in children under 12 years: 2.5mg/kg once daily in the evening.
2NO
ALSO MONOTRIM TABLETS Trimethoprim, 100mg, 200mg. White, round tab. with score line with resp. AE and 2 or DE and 5 on each side of score line. 100mg-100, A4.59; 200mg-100, A9.88. P RTIs and UTIs treatment: 200mg twice daily for 7-10 days; 1st dosage on 1st day may be doubled. Prophylaxis of recurrent UTIs: Usual dose, 100mg at night; an extra 100mg may be taken in the morning, if necessary. Renal impairment, see SPC. Q Children: Under 12 years, not recommended. Over 12 years, as per adults. D Blood dyscrasias, severe renal insufficiency where blood levels cannot be monitored. Pregnancy, premature infants and neonates Q 6 weeks. B May cause depression of haemopoiesis. METRONIDE Clonmel Perform regular haematological tests during long 2MO term therapy. Caution: Folate deficiency. May Nitroimidazole. Metronidazole 200mg. White cause hyperkalaemia (monitor serum electrolytes). scored tab. coded MZL 200 and white scored tab. Monitor blood glucose if used with concomitant coded MZL 400. Both marked with twin triangle repaglinide. Lactation. logo on reverse. 200mg-21, A1.62. C Caution: Folate antagonists, S Infections due to anaerobic pathogens. anticonvulsants, bone marrow depressant, phenytoin, digoxin, ciclosporin, warfarin and other P 400mg three times daily. coumarins, ACE inhibitors, procainamide, Q 7.5mg/kg body weight 3 times daily. oestrogens, dapsone, repaglinide. Diuretics (K+ B Pregnancy, lactation, liver disease. sparing diuretics, eplerenone and thiazides). C Alcohol, oral anticoagulants, A GI, dermatological, hypersensitivity, phenobarbitone, cimetitdine and lithium. hepatic reactions. A GI distress, furred tongue, unpleasant taste. Urticaria, angioedema, CNS disturbances, Antigen dark urine. Neuropathy, epileptiform seizures and ORAMOX 2NO leucopenia on long term therapy.
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 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. S Treatment of infections due to organisms sensitive to amoxycillin. Oral prophylaxis of endocarditis related to dental procedures. Uncomplicated gonorrhoea. P Usual dosage, 250mg three times daily. In severe infections dosage may be doubled. Oral prophylaxis, a single 3g dose prior to dental procedure. Gonorrhoea, single 3g dose. Q Up to 10 years, half the adult dosage. Oral prophylaxis, single dose of 1-1.5 g prior to dental procedure. Over 10 years, same as adult. D Hypersensitivity to penicillins, or cephalosporins. B Infectious mononucleosis. Prolonged use. Pregnancy, lactation. C Probenecid. Methotrexate. A Nausea, vomiting, diarrhoea, skin rashes, urticaria, angioedema, anaphylaxis, pseudomembranous colitis.
ANTIBACTERIAL DRUGS 8.1 recommended. Probenecid, allopurinol, digoxin, anticoagulants, oral contraceptives; caution. A Hypersensitivity reactions; skin reactions (exanthema, pruritis). Dry mouth, taste disturbance, GI disorders, increased hepatic enzymes.
PINACLOR
Pinewood
2NO
C Chloramphenicol, erythromycins, sulfonamides, tetracyclines, probenecid, copper sulphate laboratory tests. A Hypersensitivity reactions. GI disturbances.
PIPERCIN
Clonmel
2N
Broad spectrum penicillin/beta-lactamase inhibitor. Piperacillin (Na+)/ tazobactam (Na+), 4g/500mg. Powder for sln for inj. or inf. 1 vial, price on 2NO request. ALSO PINACLOR SUSPENSION Cefaclor 125mg, S Moderate to severe systemic and/or 250mg/5ml. Powder to prepare strawberry local bacterial infections in which betalactamase flavoured susp. 125mg/5ml-100ml, A3.67; 250mg/ producing bacteria suspected or detected. Adults/ 5ml-100ml, A6.56. Adolescents/elderly: Nosocomial pneumonia, S Infections of the upper and lower complicated UTIs (incl. pyelonephritis), intrarespiratory tract and middle ear incl. Streptococcus abdominal infections, skin and soft tissue pyogens (group A beta haemolytic streptococci), infections, bacterial infections in neutropenic Branhamella catarrhalis. UTIs. adults. Children (2-12 years): Bacterial infections in P 250mg eight hourly, max. 4g daily. neutropenic children. Haemodialysis: 250mg -1g prior to dialysis P By slow IV injection (over at least 3-5 followed by 250-500mg every 6-8 hrs 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 1 month, 20mg/kg daily in divided doses every depends on severity and localisation of infection: eight hours. This may be increased to 40mg/kg 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 may be divided and given 12 hourly. Max. 1g combination with an aminoglycoside. Renal daily. insufficiency: See SPC. PINACLAV Pinewood D Pregnancy, lactation. Q Under 2 years, not recommended. 2-12 B Hypersensitivity to penicillins, GI disease years, neutropenia: Q40 kg, adjust dose to 90mg/ 2NO particularly colitis, impaired renal function. b-lactamase inhibitor/broad-spectrum penicillin. kg (80mg/10mg) every 6 hours in combination Superinfection after prolonged usage, positive 250mg/125mg: Amoxicillin 250mg (as amoxicillin with an aminoglycoside, not exceeding 4g/500mg Coomb’s test, false positive Benedicts/Fehling’s trihydrate), clavulanic acid 125mg (as K+ every 6 hours. Renal insufficiency: See SPC. Over clavulanate). 500mg/125mg: Amoxicillin 500mg (as Copper Sulphate test. Avoid: History of fructose 12 years, as per adults. intolerance, glucose-galactose malabsorption, amoxicillin trihydrate), clavulanic acid 125mg (as B Hypersensitivity reactions to penicillins, sucrase-isomaltase insufficiency. K+ clavulanate). Both light yellow oblong tabs. cephalosporins, other allergens. May occur: scored one side and marked 375 or 625 on other. C Warfarin, probenecid. Pseudomembranous colitis, leucopenia and A Allergic reactions, GI disturbances, A 250mg/125mg-21, 6.10; 250mg/125mg-100, neutropenia (esp. prolonged therapy; periodic full haematological reactions, hepatitis, jaundice, A29.15; 500mg/125mg-15, A7.94. blood count), bleeding manifestations, nephritis, nervousness, confusion, insomnia, S Infections of the respiratory tract, ENT, hypokalaemia (low K+ reserves; periodic electrolyte dizziness, reversible hyperactivity, hypertonia, UTI, skin and soft tissue. determinations), modest elevation of liver function hallucinations, somnolence, genital puritus, P 250mg/125mg: 1 tab. three times daily. indices, emergence of resistant organisms. vaginitis. 500mg/125mg: 1 tab. twice daily. Swallow tabs. Prolonged therapy: Assess organ system functions whole with water at start of meal. Impaired renal PINAMOX Pinewood periodically (incl. renal, hepatic). Increased function: See SPC. Hemodialysis patients: 1 tab. incidence of fever and rash in cystic fibrosis 2NO daily. patients associated with piperacillin therapy. Broad spectrum penicillin. Amoxycillin 250mg, Q Over 12 years with body weight r Pregnancy, lactation (only if clearly indicated). 500mg. Ivory/red caps. marked with cap. name 40kg, as per adults. Contains Na+. 2NO and strength. 250mg-100, A12.26; 500, A61.43; C Caution: Probenecid, tobramycin and 1000, A122.88; 500mg-100, A24.55; 500, A122.88. gentamicin (severe renal dysfunction), vecuronium, ALSO PINACLAV SUSPENSION Amoxycillin 2NO (trihydrate) 125mg, clavulanic acid (as K+ methotrexate, heparin, oral anticoagulants and clavulanate) 31.25mg per 5ml. Powder for susp. ALSO PINAMOX SUSPENSION Amoxycillin 125mg/ other drugs affecting coagulation incl. Powder for 100ml, A3.56. 5ml, 250mg/5ml. 125mg-100ml, A1.54; 250mgthrombocyte function. Possible cross reaction with Q Under 3 months, not recommended; 3-9 100ml, A3.07. Bio-Rad Lab Platelia Aspergillus EIA test. S Infections due to organisms sensitive to A GI disorders, rash (incl. maculopapular months, 2.5ml half-strength susp.; 9 months-2 amoxicillin, oral prophylaxis of endocarditis from years, 2.5ml full strength susp. or 5ml halfrash). strength susp.; 2-6 years, 5ml full strength susp. All dental procedures, acute uncomplicated gonorrhoea. three times daily. PRIMACINE Pinewood P Usual, total daily dose is 750mg in 3 D Hypersensitivity to penicillin or 2NO divided doses. Uncomplicated gonorrhoea: 3g cephalosporins, severe hepatic impairment, Macrolide. Erythromycin (ethyl succinate) 125mg, single dose. Dental procedures: 3g single dose previous history of amoxicillin-clavulanateprior to procedure. Renal Insufficiency: Total daily 250mg, 500mg/5ml. 125mg-100ml, A1.96; 250mgassociated hepatic dysfunction. 100ml, A3.03; 500mg-100ml, A5.59. dose may need reduction if excretion of drug is B Hepatic dysfunction. Severe GI S Erythromycin sensitive infections. complaints, glandular fever, lymphatic leukaemia; delayed. P 1g twice daily. Severe infections, max. Q Over 10 years: 750mg in 3 divided not recommended. Caution: Severe allergies or doses. 6-10 years: 375-750mg in divided doses, 2-5 4g daily. asthma, elderly. Long term use; monitor kidney/ years: 375mg daily in divided doses. Under 2 years: Q Under 2 years, 125mg six hourly; 2-8 liver functions and hematological controls years, 250mg six hourly; over 8 years, same as 100-300mg daily in divided doses. Dental regularly. Pregnancy (only if benefit outweigh + adults. risk), lactation. Susp. contains aspartame, Na and procedures: 3g single dose prior to procedure. B Liver impairment. sucrose. Tabs. contain sucrose. D Pregnancy, lactation. C Theophylline, oral anticoagulants, C Bacteriostatic chemotherapeutics/ B Infectious mononucleosis. carbamazepine. antibiotics (tetracyclines, macrolides, sulfonamides Superinfection, anaphylaxis. Suspension contains or chloramphenicol), disulfiram; not sucrose and sodium. A GI disturbance. Allergic reactions. Cephalosporin. Cefaclor 250mg. Purple/white cap. Marked CEFACLOR 250. 100, A31.73.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
199
8.1 ANTIBACTERIAL 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. S Infections of the respiratory, GI and urinary tract incl. urethral, rectal and pharyngeal gonorrhea caused by sensitive bacteria. P 100-750mg twice daily swallowed whole with liquid, depending on severity and type of infection (see SPC). Duration 5-10 days. Continue for min. 3 days after symptoms have disappeared. Q Children and growing adolescents, not recommended. If benefit outweighs risk, dosage depends on severity of infection; admin. in two divided doses. 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. Patients should be well hydrated. Tendon inflammation and rupture (discontinue). C Drugs containing magn., alum., Ca++ or iron salts (not within 4 hours). Caution: Theophylline, some NSAIDs, anticoagulants, cyclosporin, glibenclamide, probenecid, metoclopramide. A GI disturbances, CNS disturbances, hypersensitivity/skin reactions, hepatic and renal disturbances, arthralgia, joint swelling, myalgia, effects on haematological parameters.
ROCEPHIN
ANTI-INFECTIVES
DRUGS
Roche
2NO
soln. for infusion. 1, A69.60. S Nosocomial pneumonia, skin and soft tissue infections, and clinically significant infections due to vancomycin resistant E. faecium, when no other treatment is appropriate. P Administer by central venous catheter in 5% glucose soln. over 60min. then flush with 5% 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 100ml, A2.30. 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.
80mg, sulphamethoxazole 400mg per 5ml. 100ml, A5.07. S Infections of respiratory and urinary tract. Otitis media. P 2 tabs. or 10ml twice daily. Q Under 6 years, use paed. susp.; 6_12 years, 1 tab. or 5ml twice daily.
2NO
SUPRAX
sanofi-aventis Glycopeptide. Teicoplanin 200mg, 400mg. Vials
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 2NO followed by 200mg I.V. or I.M. daily. Prophylaxis: ALSO SUPRAX PAEDIATRIC SUSP. Cefixime 400mg I.V. at induction of anaesthesia. Dosage in 100mg/5ml. Powder for oral susp. 50ml, A9.33; elderly, CAPD patients and renal impairment, see 100ml, A16.74. SPC. Q 9-12 years, 15ml daily as single or two Q Over 2 months: Severe infections and divided doses; 5-8 years, 10ml daily; 2-4 years, 5ml neutropenia 10mg/kg every 12 hours I.V. for first 3 daily; 6 months-2 years, 8mg/kg daily; under 6 doses followed by 10mg/kg I.V. or I.M. daily. months, not recommended. Moderate infections: 10mg/kg I.V. every 12 hours B Renal impairment, severe GI for the first 3 doses followed by 6mg/kg I.V. or disturbances, parenteral or poor nutrition, I.M. dose. Neonates: 16mg/kg on first day, then predisposition to allergic reaction; caution. Elderly 8mg/kg once daily I.V. inf. over 30 mins. or debilitated. Pregnancy, lactation (only if D Hypersensitivity to teicoplanin. essential). B Cross hypersensitivity with vancomycin, C Caution: Penicillins, anticoagulants, may occur. Thrombocytopenia, hepatic, renal or aminoglycoside antibiotic, polymyxin B, colistin or auditory impairment. Possibility of ototoxicity and high-dosed loop diuretics. superinfection. Pregnancy, lactation. SEPTRIN GSK A GI disturbances, headaches, dizziness, C Caution: Other nephrotoxic or ototoxic rashes. 2NO drugs, e.g. streptomycin, neomycin, kanamycin, Folic acid inhibitor/sulphonamide. Trimethoprim gentamicin, amikacin, tobramycin, cephaloridine SYNERCID Nordic 80mg, sulphamethoxazole 400mg; white tab. and colistin. coded Y2B and marked WELLCOME. 100, A12.88. 2 J A Erythema, local pain, thrombophlebitis, 2NO injection site abscess. Rash, pruritis, fever, Streptogramin. Quinupristin 150mg and bronchospasm, anaphylactic reactions and ALSO SEPTRIN ADULT SUSPENSION Trimethoprim dalfopristin 350mg. Vial containing powder for
Cephalosporin. Ceftriaxone (as disodium) 1g. Powder in vials plus solvent amps. (GMS)1g: (IM)-1, A10.68; (IM/IV)-1, A10.68. S Septicaemia, respiratory tract infections, renal and urinary tract infections, abdominal infections, and soft tissue infections, meningitis, gonorrhoea. Prophylaxis of surgical infections. P 1g once daily by IM or IV inj. Severe infections: 2-4g once daily. Gonorrhoea: 250500mg IM or IV as a single dose. Q Neonates, max. 50mg/kg daily. standard dose, 20-50mg/kg daily. Severe infections, max. 80mg/kg once daily. D Cephalosporin hypersensitivity. Safety in pregnancy has not been established. B Care is required in patients with a history of hypersensitivity (especially anaphylactic reaction) to penicillins. Severe renal impairment. Patients with radio-opaque gallstones or obstructive biliary tract disease should be carefully monitored. A Gastrointestinal, nausea, vomiting, stomatitis and glossitis, maculopapular rash, pruritus, urticaria and allergic dermatitis, anaemia, thrombocytopenia.
200
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.
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 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.
ANTIBACTERIAL DRUGS 8.1 2NO
ALSO TAVANIC INFUSION Levofloxacin 5mg/ml. Soln. in vial. 100ml. P Community-acquired pneumonia: 500mg once or twice daily. Complicated UTIs including pyelonephritis: 250mg once daily. Chronic bacterial prostatitis: 500mg once daily. Skin and soft tissue infections: 500mg twice daily. Renal insufficiency, TARIVID sanofi-aventis see SPC. D Children and growing 2NO adolescents.Epilepsy, history of tendon disorders Quinolone antibacterial. Ofloxacin 200mg with a fluoroquinolone. Pregnancy, lactation. yellowish-white film-ctd oblong tab. 20, A11.15. S Respiratory and urinary tract infections, B Tendinitis and tendon rupture, Clostridium difficile-associated disease, skin and soft tissue infections due to Gram pseudomembranous colitis, predisposition to positive or Gram negative organisms sensitive to seizures, haemolytic reactions in glucose-6-PD ofloxacin. patients, and hypoglycaemia. Avoid exposure to P Respiratory tract infections, usually UV radiation. Psychotic reactions, QT interval 400mg daily increasing if necessary to 400mg twice daily. Upper UTI, 200-400mg daily increasing prolongation, peripheral neuropathy and hepatobillary disorders. if necessary to 400mg twice daily. Lower UTI, 200C Magnesium or aluminium containing 400mg daily for 3-10 days. Severe infections 300antacids, iron salts, sucralfate, theophylline, 400mg daily. Non-gonococcal urethritis and fenbufen or similar NSAIDs, probenecid and cervicitis, 400mg daily in single or divided doses. Uncomplicated gonorrhoea, single dose of 400mg. cimetidine, ciclosporin, vitamin K antagonists. Skin and soft tissue infections, 400mg twice daily. Drugs known to prolong QT interval. A Diarrhoea, nausea, hepatic enzyme Q Not recommended. increased, phlebitis, infusion site reaction. 2N ALSO TARIVID INFUSION SOLUTION (Hospitals TAZOCIN Wyeth only) Ofloxacin 100mg (as ofloxacin (HCl) 110mg) 2NO in 50ml soln. 200mg (as ofloxacin hydrochlor. 220mg) in 100ml soln. 100mg_50ml, A11.73. Beta-lactamase inhibitor/broad-spectrum penicillin. 200mg_100ml, A23.46. Piperacillin (as Na+) with tazobactam (as Na+) 2.25g (2g: 250mg); 4.5g (4g:500mg). 4.5g (4g: S Acute and chronic respiratory and 500mg); powder in vial. Price available on request. urinary tract infections. S Adults and elderly: Lower respiratory P Respiratory tract infections, 200mg tract infections, complicated and uncomplicated twice daily. UTIs, 100mg once daily to 100mg twice daily. Skin and soft tissue infections, 400mg UTI, intra-abdominal infections, skin and skin structure infections, bacterial septicaemia. Bacterial i.v. twice daily. infections in neutropenic adults and children incl. Q Not recommended. D Epilepsy. Pregnancy, lactation or women neonates in combination with an aminoglycoside. Children: Appendicitis complicated by rupture with at risk of pregnancy. peritonitis and/or abscess formation in children B Alertness may be impaired. Renal or hepatic disorders. Exposure to sunlight or UV rays. aged 2-12 years. P 4.5g by slow IV inj. or inf. eight hourly. C Anticoagulants, mineral antacids, Neutropenia: 4.5g every 6 hrs in combination with phenylpropionic acid derived NSAIDs. A Hypersensitivity reactions, CNS disorders an aminoglycoside. Renal insufficiency: See SPC. Q Neutropenia, incl. neonates, 90mg/kg incl. headache, dizziness, sleep disturbances, every 6 hours; max. 4.5g every 6 hours. tremor, visual disturbances, psychotic reactions. Joint and muscle pains. GI upset. Changes in blood Complicated appendicitis: Under 2 years, not recommended; 2-12 years, 112.5mg/kg every 8 count. hours; max. 4.5g every 8 hours. Renal insufficiency: TAVANIC sanofi-aventis See SPC. B Assess haematopoietic function 2NO periodically; in long term therapy, also renal/ Fluoroquinolone antibiotic. Levofloxacin 250mg, hepatic function. Patients with low K+ reserves. 500mg. Yellowish-white to reddish-white oblong Bleeding, pseudomembranous colitis (discontinue scored film-ctd tabs. 250mg-10, A21.88; 500mg-10, if occurs). Evaluate patients with gonorrhoea for A31.71. S Acute bacterial sinusitis, acute bacterial syphilis. Pregnancy, lactation (only if benefit outweighs risk). exacerbations of chronic bronchitis, communityC Probenecid, drugs affecting coagulation, acquired pneumonia, uncomplicated UTIs, complicated UTIs including pyelonephritis, chronic non-depolarising muscle relaxants, methotrexate. Bio-Rad Lab. Platelia Aspergillus EIA test. bacterial prostatitis and skin and soft tissue Hartmann’s or Lactated Ringer’s solns compatible infections. P Acute sinusitis: 500mg once daily for 10- with Tazocin containing EDTA only. 14 days. Chronic bronchitis: 250mg to 500mg once A Diarrhoea, nausea, vomiting, rash. 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.
TETRALYSAL
D Advanced renal insufficiency. Pregnancy, lactation. B Hepatic or renal insufficiency. C Antacids/iron preps., anticoagulants. A GI disturbances, diarrhoea, superinfection, photosensitivity.
TOBI
Novartis
2NT Aminoglycoside antibiotic. Tobramycin 300mg/5ml. Nebuliser soln in 5ml ampoules. 56, A2947.09. S Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients. Q Under 6 years, not recommended. V 1 ampoule twice daily for 28 days with 12 hrs (and not less than 6 hrs) between doses. Stop for the next 28 days. Repeat cycle. D Pregnancy, lactation. B Renal, auditory, vestibular or neuromuscular dysfunction, severe haemoptysis; caution. Monitor tobramycin levels only through venepunture. Bronchospasm can occur. C Avoid nephrotoxic or ototoxic drugs, frusemide, urea or mannitol. A Voice alteration, transient tinnitus.
TRIMOPTIN
Athlone
2NO 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, procainamide, cyclosporin. Diagnostic tests (serum methotrexate assay with use of dihydrofolate reductase, Jaffe reaction).
TRUOXIN
Helsinn Birex
Galderma 2 N O
2NO 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.
4-quinolone. Ciprofloxacin 250mg, 500mg. White or yellowish scored film-ctd tabs. marked C250 or C500. 250mg-10, A5.42; 20, A10.97; 500mg-10, A10.19; 20, A20.45. S Infections of the respiratory tract, UTI, GI tract incl. gonorrhoea caused by sensitive bacteria.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
201
MIMS Ireland
A fundamental part of every doctorâ&#x20AC;&#x2122;s working day
ANTI-INFECTIVES 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.
ANTIBACTERIAL DRUGS 8.1 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.
TYGACIL 2NO
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).
VELOSEF
BMS
2NO
Cephalosporin. Cephradine 250mg orange/blue cap. coded SQUIBB 113. 500mg blue cap. coded SQUIBB 114. 250mg-20, A4.13; 100, A19.88; Wyeth 500mg-20, A8.15; 100, A39.26.
Tetracyclines. Tigecycline 50mg. Powder for soln for inf. Price on request. S Complicated skin and soft tissue infections. Complicated intra-abdominal infections. P Initially 100mg followed by 50mg every 12 hours for 5-14 days depending on severity, infection site, and clinical response. Severe hepatic impairment: 25mg every 12 hours following the 100mg loading dose. Q Under 18 years, not recommended. D Pregnancy (unless clearly recommended). B Severe underlying diseases, limited data. TRUOXIN I.V. Helsinn Birex Consider combination antibacterial therapy in severely ill patients with complicated intra2J abdominal infections secondary to clinically 4-quinolone. Ciprofloxacin 2mg/ml. Clear, apparent intestinal perforation or patients with colourless to slightly yellow sln for inf. Vials: incipient sepsis or septic shock. May occur: A 200mg/100ml-10, 180.00; bags: 400mg/200ml-1, Pseudomembranous colitis, acute pancreatitis A20.00. (consider discontinuation), anaphylaxis, cholestasis S Adults: Lower RTIs due to Gram-ve (monitor). May cause overgrowth of nonbacteria; chronic suppurative otitis media; acute susceptible organisms. May cause permanent tooth exacerbation of chronic sinusitis esp. if caused by discolouration in humans if used during tooth Gram-ve bacteria; UTIs; epididymo-orchitis incl. development. Lactation. Driving or using machines cases due to N. gonorrhoeae; pelvic inflammatory if dizziness occurs. disease incl. cases due to N. gonorrhoeae; GI tract C Warfarin. Oral contraceptives. infections; intra-abdominal infections; skin and A Abscess, infections, prolonged activated soft tissue infections caused by Gram-ve bacteria; partial thromboplastin time, prolonged malignant external otitis, infections of bones and prothrombin time, dizziness, phlebitis, GI joints; treatment and prophylaxis of infections in disorders, elevated AST/ALT/amylase, neutropenic patients; inhalation anthrax (posthyperbilirubinaemia, pruritus, rash, headache, exposure prophylaxis; curative treatment). Children increased BUN. and adolescents: Broncho-pulmonary infections in cystic fibrosis caused by P. aeruginosa; complicated VANCOCIN Flynn UTIs and pyelonephritis; inhalation anthrax (postexposure prophylaxis and curative treatment). May 2 J N be used to treat severe infections when necessary. Glycopeptide. Vancomycin (HCl) equiv. vancomycin 500mg (525,000 IU). Powder for concentrate for P 400mg two to three times daily. Duration of treatment depends on indication, see soln for inf. and powder for oral soln. in vial. 1, A12.30. SPC. After IV initiation of treatment, can be S Staphylococcal enterocolitis and switched to oral treatment with tab. or susp. if clinically indicated. Renal impairment: 30QccQ 60 pseudomembranous colitis. P 500mg every six hours or 1g every 12 ml/min, 200-400 every 12 h; ccQ30ml/min/ haemodialysis/peritoneal dialysis, 200-400mg every hours, in NaCl or 5% dextrose IV inf. BP. Admin. each dose at no more than 10mg/min. Max. conc. 24 h. R Adjust dose based on cc and severity of 5mg/ml, or 10mg/ml in selected patients but with disease increased risk of inf.-related events. Admin. each Q CF: 10mg/kg three times daily with max dose over 60 mins. Usually response within 48-72 400mg per dose for 10-14 days. Complicated UTIs hours. Staphylococcal endocarditis, duration 3 and pyelonephritis: 6-10mg/kg three times daily weeks or longer. with max. 400mg per dose for 10-21 days. Anthrax: Q 10mg/kg per dose, every 6 hours (total 10-15mg twice daily with max. 400mg per dose for daily dosage 40mg/kg). Neonates and young 60 days. Other severe infections: 10mg/kg three infants: Initially 15mg/kg, followed by 10mg/kg times daily with max. 400mg per dose. every 12 hours in 1st week of life and every 8
2NO ALSO VELOSEF SYRUP Cephradine 250mg per 5ml; powder for susp. 100ml, A4.91. S Infections of respiratory and gastrointestinal tracts and of skin and soft tissues, bones and joints. Septicaemia, endocarditis. Prophylaxis in surgery. UTI. P 1-2g daily in 2 or 4 divided doses; max. 4g daily. Q 25-50mg/kg daily in 2 or 4 divided doses. Otitis media: 75-100mg/kg daily in divided doses; max. 4 g daily. Continue in all cases for 4872hours after patient is asymptomatic.
2NO ALSO VELOSEF INJECTION Cephradine 500mg, 1g. Powder in vials. 500mg-5, A5.78; 1g-1, A2.27. P 2-4g IM, IV or IV inf. daily in divided doses. 8g in severe infections. Q 50-100mg/kg daily in divided doses. Severe infections, 200-300mg/kg daily. B Hypersensitivity to penicillins. Renal impairment. C Loop diuretics, aminoglycosides. A Hypersensitivity reactions. GI disturbances. Rarely, pain at inj. site, candidiasis, eosinophilia, neutropenia, leucopenia, thrombocytopenia, rise in liver enzymes and blood urea. Positive Coomb’s test.
VIBRAMYCIN
Pfizer
2NO Tetracycline. Doxycycline (HCl) 50mg, 100mg. Green cap. marked PFIZER and Vibracina. 50mg-28, A6.01; 100mg-8, A3.26; 100mg-12, A4.89. S Pneumonia; respiratory, gastro-intestinal tract, soft tissue and ophthalmic infections. UTI. STD. P Usually 200mg with food or fluid on the first day then 100-200mg daily. STD, see SPC. Q Under 12 years, not recommended. 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
203
8.2 ANTIFUNGAL
ANTI-INFECTIVES
DRUGS
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, heparin therapy r 15 international units/kg/h, severe hepatic disease, increased risk of bleeding, low platelet count Q30,000 x 106/L. B Recent ischaemic stroke. Monitor haemostasis during inf. Uncontrolled or worsening coagulopathy. Possibility of allergic reactions. Pregnancy, lactation (only if essential). Contains sodium. C Protein C, thrombolytics, oral anticoagulants, hirudins, antithrombin, aspirin, other antiplatelets agents eg. NSAIDs, prostacyclins. A Risk of bleeding, serious bleeding events (ecchymosis, GI tract/CNS bleeding), headache, pain.
confusional states. Lactation. B Complete blood counts (incl. Hb levels, platelets, and total and differentiated leucocyte counts) should be monitored weekly. Risk of myelosuppression (including anaemia, leucopenia, pancytopenia and thrombocytopenia). Lactic acidosis, pseudomembranous colitis, peripheral and optic neuropathy have been reported. Severe renal or hepatic insufficiency. Pregnancy (unless ZITHROMAX Pfizer benefit outweighs risk). Sln for inf. contains glucose. Oral suspension contains aspartame 2NO + 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, C Contra: MAOIs (or within 2 weeks), A16.13. 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 with otitis media or more serious infections, 250mg twice daily. B Penicillin hypersensitivity. Pregnancy, lactation. A GI disturbances. Hypersensitivity reactions. Pseudomembranous colitis. Eosinophilia, transient candidiasis. Increase in liver enzymes and positive Coombâ&#x20AC;&#x2122;s test.
ALSO ZITHROMAX SUSPENSION Azithromycin (dihydrate) 200mg/5ml; Powder for susp. Reconstituted in water to give cherry/banana flavoured susp. Powder for 15ml (with spoon + 10ml oral syringe), A5.75; Powder for 22.5ml (with A8.63. spoon), ZINACEF GSK Q Under 3 years (Q15kg), 10mg/kg; 3-7 2NO years, 5ml; 8-11years, 7.5ml; 12-14 years, 10ml. All Cephalosporin. Cefuroxime (sodium salt) 250mg, as single daily dose for 3 days taken with food. 750mg, 1.5g. Vials. (GMS)250mg (IM or IV use)-5, D Hepatic disease. A5.12; (GMS)750mg (IM or IV use)-5, A15.33; 1.5g B Renal or hepatic impairment. Pregnancy, A for IV inj.-1, 7.22. lactation. S Respiratory tract and soft tissue C Ergot derivatives, antacids, cyclosporin, infections, serious infections pending bacteriology. digoxin, warfarin, terfenadine. Meningitis. Prophylaxis against infection in surgical A GI upset, anorexia, allergic reactions, procedures. UTI and gonorrhoea. photosensitivity, arthralgia, oedema, angioneurotic V See lit. oedema, anaphylaxis, abnormal liver function, B Loop diuretics. Mild to moderate hepatitis, cholestatic jaundice, dizziness, vertigo, hearing loss reported in paediatric patients. convulsions, headache, somnolence, intestinal C Oral contraceptives. Avoid: Dilution in nephritis, acute renal failure, palpitations, Na+ bicarbonate, admixture with other arrythmias, asthenia, paraesthesia. medications in sln during IV admin. Interferes with tests for glycosuria depending on copper ZYVOX Pharmacia reduction. 2NT A Hypersensitivity, GI reactions. See SPC. Oxazolidinone. Linezolid 600mg. White film-ctd
ZINNAT
GSK
2NO
2NT
Cephalosporin. Cefuroxime (axetil) 125mg, 250mg, 500mg. White biconvex capsule shaped film-ctd tabs. marked GXES5, GXES7 or GXEG2 resp. 125mg-14, A7.28; 250mg-14, A9.49; 500mg-14, A18.03.
2NO ALSO ZINNAT ORAL SUSPENSION Cefuroxime (axetil) 125mg/5ml. 70ml, A8.40.
2NO ALSO ZINNAT 250MG ORAL SUSPENSION Cefuroxime (axetil) 250mg/5ml. 70ml, A15.11. S Otitis media. Infections of upper and lower respiratory tract e.g. tonsillitis, pharyngitis, bronchitis and pneumonia. Skin and soft tissues. UTI. Gonorrhoea. Prevention and treatment of Lyme disease. P Tabs. are best taken after food. Most infections, 250mg twice daily. Severe infections, 500mg twice daily. Gonorrhoea, 1g as a single dose. Q Under 3 months, not recommended; over 3 months, 125mg twice daily. Over 2 years
204
ovaloid tab. marked Zyvox 600mg one side. 10, A617.61. ALSO ZYVOX ORAL SUSPENSION Linezolid 100mg/5ml. White to light yellow orange flavoured granules. 150ml, A308.80.
2NO ALSO ZYVOX INFUSION Linezolid 600mg per 300ml. Isotonic clear colourless to yellow soln. 10 x 300ml, A617.74. S Nosocomial pneumonia, community acquired pneumonia and complicated skin and soft tissue infections when known or suspected to be caused by susceptible Gram positive bacteria. P 600mg twice daily for 10-14 days. Max. duration: 28 days. Duration is dependent on pathogen, infection site, severity, and patient clinical response. Initiate in hospital, after consultation with relevant specialist. Combination therapy necessary if concomitant Gram negative pathogen suspected. Q Under 18 years, not recommended. D Uncontrolled hypertension, phaeochromocytoma, carcinoid thyrotoxicosis, bipolar depression, schizoaffective disorder, acute
8.2 ANTIFUNGAL DRUGS
ABELCET
Cephalon
2N Polyene antibiotic. Amphotericin B lipid complex (ABLC) 5mg (5000 units/ml). Susp. in 20 ml (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 inf.-related ad-events. C Nephrotoxic drugs, cyclosporin (monitor renal function). Zidovudine (monitor renal and haematologic function). A Mild/moderate (first 2 inf.). Chills, fever, nausea, vomiting, increased BP, dyspnea.
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
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
ANTIFUNGAL DRUGS 8.2
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 blue cap and body. 50mg-7, A12.56; 150mg-1, A5.31. 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.
rufabutin, tacrolimus, astemizole or other drugs metabolised by cytochrome P450. A GI symptoms. Also reported: Dizziness, seizures, alopecia, exfoliative skin disorders, toxic CANCIDAS MSD epidermal necrolysis, dyspepsia, vomiting, leucopenia, thrombocytopenia, immunological 2JN anaphylaxis (incl. angioedema, face oedema, Systemic antifungal. Caspofungin (as caspofungin pruritus), hepatic failure, hepatitis, hepatocellular acetate) 50mg , 70mg. Vial containing white to off-white compact, lyophilised powder concentrate necrosis, jaundice, hypercholesterolaemia, hypertriglyceridaemia, hypokalaemia and taste for soln. for infusion. 50mg-1, A537.11; 70mg-1, perversion. A683.18. S Invasive candidiasis (adults and DIFLAZOLE Pinewood paediatric patients), invasive aspergillosis in adults and paediatric patients refractory to/intolerant of 2 M O Triazole. Fluconazole 50mg, 150mg, 200mg. amphotericin B or itraconazole, presumed fungal Green-white, yellow and white capsules resp. infections (eg. Candida or Aspergillus) in febrile, 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, neutropenic adult or paediatric patients. P Under 80kg, 70mg on day 1, then 50mg A51.60. daily. Over 80kg, 70mg on day 1, then 70mg daily. S Genital candidiasis (acute or recurrent Invasive candidiasis: Duration at least 14 days after vaginal candidiasis, candidal balanitis). Mucosal candidiasis. Tinea pedis, tinea corporis, tinea cruris, last positive culture (consider oral therapy with tinea versicolor and dermal Candida infections. other antifungal during this time). Invasive Systemic candidiasis incl. candidaemia, aspergillosis/fungal infection: Duration at least 7 disseminated candidiasis and other forms of days after resolution of symptoms. Moderate invasive candidal infection. Cryptococcosis, hepatic insufficiency: 35mg daily. including cryptococcal meningitis and infections of R Limited treatment experience in other sites (pulmonary, cutaneous). Prevention of patients 65 years and older. 2 relapse of cryptococcal disease in AIDS patients. Q 12 months to 17 years: single 70mg/m loading dose (not to exceed actual dose of 70mg) Prevention of fungal infections in at risk immunocompromised patients. on day 1, followed by 50mg/m2 daily (not to exceed actual dose of 70mg). If well tolerated but P Genital: 150mg single oral dose. 2 Mucosal: Oropharyngeal, 50mg daily for 7-14 days. inadequate response increase to 70mg/m Others, 50mg daily, for 14-30 days; or 100mg daily D Pregnancy, lactation. Diluents in difficult cases. Tinea and dermal: 50mg once containing glucose, co-infusion with other daily. Duration 2-4 weeks; tinea pedis, up to 6 medicinals. weeks. Systemic: 400mg on day 1 followed by B Mild/moderate hepatic impairment. Severe hepatic impairment (no clinical experience). 200mg daily; max., 400mg daily. Cryptococcal: 400mg on the 1st day followed by 200-400 mg C Cyclosporin (monitor liver enzymes), tacrolimus, metabolic enzyme inducers (efavirenz, once daily; duration at least 6-8 weeks for nevirapine, rifampicin, dexamethasone, phenytoin, cryptococcal meningitis. Prevention of cryptococcal relapse in AIDS, 100-200mg daily. Prevention of carbamazepine). A Fever, hypotension, anaemia, headache, fungal infections in immunocompromised: 50400mg once daily based on patient’s risk. Start tachycardia, inj. site reactions, chills, GI disorders, several days before anticipated onset of rash, pruritis, sweating, arthralgia, dyspnoea, neutropenia; continue for 7 days after neutrophil elevated liver enzymes and creatinine, decreased count rises q1000 cells/mm3. Renal impairment, + Hb, haematocrit, blood albumin and serum K , (11-50 ml/min) 100% dose on day 1, 50% increased glucose, decreased phosphorus, thereafter (if no dialysis), or 100% after each increased phosphorus, and increased eosinophils. 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. A5.49. 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. recommended unless no alternative. D Pregnancy (use contraception), lactation. D Pregnancy, lactation. B May occur: Abnormalities in B Discontinue if liver disease, rash haematological, hepatic, renal and other (superficial infection) or bullous lesions/erythema biochemical function tests (particularly in AIDS and multiforme (systemic infection) occur. Exfolliative cutaneous reactions, toxic epidermal necrolysis cancer patients); monitor for development of more serious hepatic injury. Exfoliative cutaneous (AIDS patients). C Terfenadine or cisapride reactions (e.g. Steven-Johnson syndrome, toxic (contraindicated). Caution: Anticoagulants, epidermal necrolysis) may rarely occur. If rash benzodiazepines, sulphonylureas, HCTZ, develops, further fluconazole therapy not phenytoin, rifampicin, ciclosporin, theophylline, recommended. Anaphylaxis reported rarely. zidovudine, rifabutin, tacrolimus, other substrates Contains lactose. C Contra: Terfenadine, cisapride. Caution: of cyt P450. A Headache, rash, GI disorders. Coumarin anticoagulants, oral sulphonylureas, hydrochlorothiazide, midazolam, phenytoin , DIFLUCAN Pfizer rifampicin, cyclosporin, theophylline, zidovudine,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
205
8.2 ANTIFUNGAL
ANTI-INFECTIVES
DRUGS
2MO
2MO
Triazole. Fluconazole 50mg, 200mg Blue/white cap. and purple/white cap. Both marked FLU, cap. strength and PFIZER. 50mg-7 (Cal/Pk), A12.91; 200mg-7 (Cal/Pk), A51.63.
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 Mycoses caused by yeast fungi (Candida 2MO and cryptococci), incl. systemic candidiasis (eg. ALSO DIFLUCAN ORAL SUSP. Fluconazole 50mg, 200mg/5ml. White powder which yields an orange candidaemia, candiduria), cryptococcal meningitis, superficial mucosal candidiasis. Relapse prophylaxis flavoured susp. 50mg/5ml-35ml, A19.85; 200mg/ of cryptococcal meningitis in AIDS patients, 5ml-35ml, A79.40. prevention of candidiasis in patients with S Mucosal candidiasis. Systemic malignancies during chemotherapy or candidiasis, cryptococcosis. Prevention of fungal radiotherapy and in immunocompromised infections in immunocompromised patients patients. Fungal infections of the skin. following cytotoxic chemotherapy, radiotherapy. P Systemic, 400mg on first day, then 200- P Systemic candidiasis/ cryptococcal meningitis: 400mg once daily on day 1, then 400mg once daily. Mucosal, 50mg daily for 14-30 200mg once daily; may be increased to 400mg days; max. 100mg daily in difficult cases. once daily. Duration: Cryptococcal meningitis, 6-8 Prophylaxis in immunocomppromised, 50-400mg weeks. Candiduria: 50mg once daily for 14-30 once daily starting several days before onset of days. If severe, may be increased to 100mg once neutropenia. Prevention of relapse of cryptoccal daily. Mucosal candidiasis: 50mg once daily for 14meningitis, 100-200mg daily. 30 days (oropharyngeal, 7-14 days); may be Q Mucosal: neonates, 3mg/kg every 72 increased to 100mg once daily if severe (except for hours; 2-4 weeks, 3mg/kg every 48 hours; over 4 chronic-atrophic condition). Relapse prophylaxis of weeks, 3mg/kg daily. Loading dose of 6mg/kg. Systemic: neonates, 6-12mg/kg every 72 hours; 2-4 cryptococcal meningitis: 100-200mg once daily weeks, 6-12mg/kg 48 hours; over 4 weeks, 6-12mg/ while monitoring laboratory values. Prevention of candidiasis: Immunocompromised, 50mg once kg daily. Prophylaxis in immunocomprimised: neonates, 3-12mg/kg every 72 hours; 2-4 weeks, 3- daily; during chemotherapy or radiotherapy, 12mg/kg every 48 hours; over 4 weeks, 3-12mg/kg 400mg once daily, initiated 2-3 days prior to anticipated onset of neutropenia and continued a daily. further 7 days after neutrophile number q1000 2NO cells/mm3. Renal impairment (Q 50ml/min): 50ALSO DIFLUCAN IV INFUSION Fluconazole 2mg/ 400mg/day on day 1, then 50% or 48 hours 100% A A ml. Soln. 25ml, 8.76; 100ml, 35.04. P IV inf. at a rate of 5-10ml/min. See SPC. thereafter (if no dialysis), or 100% after each dialysis. Fungal infections of the skin: Tinea Q Not recommended. corporis/cruris, pityriasis versicolor: 50mg once D Pregnancy. daily or 150mg once weekly for 2-4 weeks. Tinea B Impairment in hepatic, renal or pedis: 50mg once daily for up to 6 weeks. haematological function, lactation. Q Under 16 years, not recommended C Cisapride, terfenadine, anticoagulants, except in case of no therapeutic alternative. oral hypoglycaemics, phenytoin, rifampicin, Mucosal candidiasis: 3mg/kg daily. 6mg/kg may be benzodiazepines, cyclosporin, theophylline, used on day 1. Systemic candidal/ cryptococcal tacrolimus, rifabutin. A GI disorder, headache, anaphylaxis, rash, infections: 6-12mg/kg daily. Prevention of candida infections in neutropenic children: 3-12mg/kg daily dizziness, seizures, alopecia, exfoliative skin depending on extent and duration of neutropenia disorders, dyspepsia, vomiting, hepatitis, (see adult dosing). leucopenia, neutropenia, agranulocytosis, 2MO thrombocytopenia, angioedema, facial oedema, ALSO FLUCOL SOLUTION Fluconazole 2mg/ml. pruritus, urticaria. 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. dose as children (max. 12mg/kg) but admin. every Duration usually at least 14 days after last positive 72 hrs (1st two weeks) or 48 hrs (weeks 3 and 4). culture. Max. inf. rate 1.1mg/min (equiv. 3ml/min). 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 eg. QT prolongation, cardiomyopathy, sinus risk/benefit). bradycardia, arrhythmias. Caps. contain lactose. B Hepatic dysfunction reported. Contains Lactation (use only as single 200mg dose). fructose. C Contra: Drugs known to prolong QTC Caution: Anaesthetics. interval and metabolised by CYP3A4, eg. cisapride, A Coagulopathy, convulsion, headache, terfenadine, astemizole, pimozide, quinidine and nausea, GI disorders, rash, pruritus, hypokalaemia, halofantrine. Caution: Other substrates of CYP3A4 flushing, increased blood creatinine and hepatic or CYP2C9 (sulphonyl urea, phenytoin, losartan, enzymes. celecoxib, fluvastatin, anticoagulants), HCTZ, rifampicin, nevirapine, amitriptyline, didanosine, FLUCOL Rowex theophylline, trimetrexate, zidovudine,
206
amphotericin B. A Skin rash, headache, GI upset, increase of AST, ALT and alkaline phosphatase.
FUNGAFINE
Teva
2MO Allylamine antifungal. Terbinafine 250mg (as terbinafine HCl). White, round, flat, tab., scored on both sides with side scores, marked T above and 1 below score. 250mg-28, A29.50. S Fungal infections such as tinea corporis, tinea cruris and tinea pedis. Onychomycosis (nail infections) caused by dermatophytes. P 250mg once daily. Skin infections: 2-4 weeks. Tinea pedis, may be up to 6 weeks. Onychomycosis: 6-12 weeks. Toenail infections, usually 12 weeks but up to 6 months. Impaired renal function (ccQ50ml/min): Half dose. Q Not recommended. D Severe hepatic or renal impairment. Pregnancy (unless clearly necessary), lactation. B Chronic or active liver disease (not recommended). Cholestasis, hepatitis may occur. Psoriasis (caution). High fever or sore throat (possible haematological reaction). C Caution: CYP2D6 substrates with narrow therapeutic window, cytochrome P450 inducers (eg. rifampicin) and inhibitors, oral contraceptives. A Loss of appetite, headache, GI disorders, rash, urticaria.
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
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
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. LAMISIL Novartis Admin. for at least 1 week after neutrophil recovery. Oesophageal Candidiasis (adults only): 2MO q40kg, 150mg/day. Q40kg, 3mg/kg/day. Admin. Allyamine antifungal. Terbinafine (HCl) 250mg. for at least 1 week after resolution of clinical signs White scored tab. coded Lamisil 250. 14, A16.99; and symptoms 28, A32.78. D Pregnancy, lactation (unless clearly S Fungal infections of the skin and nails necessary). caused by Trichophyton where oral therapy is B Foci of altered hepatocytes and indicated. hepatocellular tumours observed in rats; carefully P 1 daily for 2-6 weeks in T. pedis, 2-4 monitor liver function; assess risk/benefit weeks in T. cruris, 4 weeks in T. corporis and particularly in severe liver function impairment or between 6 weeks and 3 months for finger-nail chronic liver diseases. Severe hepatic impairment: infections and 3-6 months for toe-nail infections. Insufficient data. Haemolysis and haemolytic Q Not recommended. anaemia rarely reported. Monitor renal function. D Chronic, active liver disease (avoid). Contains lactose. Pregnancy, lactation. C Mycamine in combination with B Signs for hepatotoxicity; discontinue sirolimus, nifedipine, itraconazole. and evaluate liver function. High fever or sore A All patients: Leukopenia, neutropenia, throat, evaluate for possible haematological anaemia, hypokalaemia, hypomagnesaemia, reaction. Renal impairment (ccQ50ml/min). C Caution: P450 inhibitors or inducers (eg. hypocalcaemia, headache, phlebitis, GI disorders, increased blood AP, increased AST, increased ALT, cimetidine, rifampicin), CYP2D6 substrates (eg. increased blood bilirubin (incl. TCAs, b-blockers, SSRIs, antiarrhythmics class IC, MAO-Is Type B), caffeine, desipramine, ciclosporin. hyperbilirubinaemia), abnormal liver function test, rash, pyrexia, rigors. Paediatric patients: A Headache, GI disorders, rash, urticaria, Thrombocytopenia, tachycardia, hypertension, arthralgia, myalgia. hypotension, hyperbilirubinaemia, hepatomegaly, LANAFINE Niche acute renal failure, increased blood urea.
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.
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.
NOXAFIL
Schering-Plough
2NT
Antimycotic. Posaconazole 40mg/ml. White oral suspension. 105ml, A751.55. S Invasive aspergillosis, fusariosis, chromoblastomycosis, mycetoma, coccidioidomycosis, in adults with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicines. Oropharyngeal candidiasis as 1st line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. Prophylaxis of invasive fungal infections (IFI) in: 1) Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing IFI; 2) Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high 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 2MO days before onset of neutropenia and continue MYCOSTATIN ORAL BMS for 7 days after the neutrophil count q 500 cells/ Allylamine antifungal. Terbinafine (as HCl) 250mg. mm3. Almost white, round, biconvex, scored tab. marked 2 M O Antifungal. Nystatin 100 000 units/ml. Ready Q Under 18 years, not recommended. 250. 28, A29.14. mixed susp. 30ml with dropper, A2.91. D Lactation. S Fungal infections of skin caused by S Oral and oesophageal candidosis. B Hypersensitivity to other azoles. Severe Trichophyton, Microsporum canis and V 1ml four times daily held in contact hepatic impairment. Monitor patients who Epidermophyton floccosum, ringworm (tinea with lesions. Continue for 48 hours after clinical develop abnormal liver function tests. Procorporis/cruris/pedis/capitis), onychomycosis (nail cure to prevent relapse. arrhythmic conditions. Monitor for electrolyte infections) caused by dermatophyte fungi. B Should not be used for systemic disturbances. Pregnancy. P 250mg once daily. Tinea pedis, 2-6 mycoses. Pregnancy, lactation. C Contra: Terfenadine, astemizole, weeks; corporis, 4 weeks; cruris, 2-4 weeks. cisapride, pimozide, halofantrine or quinidine, Onychmycosis: Usually 6 weeks-3 months, although A Rarely oral irritation or sensitivity, nausea. ergot alkaloids, HMG-CoA reductase inhibitors some may require 6 months or longer. Renal metabolised through CYP3A4. Avoid: Vinca impairment (ccQ50ml/min): Usually half normal NAILDERM Gerard alkaloids, rifabutin, rifampicin and similar inducers, dose. phenytoin and similar anticonvulsants, efavirenz, D Chronic or active liver disease. 2MO Pregnancy (unless benefit outweighs risk), Antifungal allylamine. Terbinafine (as HCl) 250mg. cimetidine, H2 receptor antagonists and PPIs. lactation. White, round, biconvex scored tab. marked TF 250 Caution: Medicines known to prolong the QTc interval, ciclosporin, tacrolimus, sirolimus, other B Cholestasis and hepatitis rarely and G on reverse. 14, A16.98; 28, A32.77. reported. Monitor for signs of hepatotoxicity. S Fungal infections such as tinea corporis, CYP3A4 substrates, CYP3A4 inhibitors and inducers. Psoriasis (caution). tinea cruris, tinea pedis and onychomycosis (nail A Neutropenia, electrolyte imbalance, C Caution: CYP2D6 substrates (eg. TCAs, infection) caused by dermatophytes. anorexia, paresthesia, dizziness, somnolence, SSRIs, b1-blockers, antiarrhythmics, MAOIs type B, P 250mg once daily. Skin infections: 2-4 headache, GI disorders, elevated liver function antipsychotics), inhibitors/inducers of P450 weeks; tinea pedis: Up to 6 weeks. Fingernail tests, rash, pyrexia, asthenia, fatigue. enzymes (e.g. rifampicin, cimetidine). onychomycosis: 6 weeks. Toenail onychomycosis: A GI symptoms, rash, urticaria, arthralgia, 12 weeks, sometimes up to 6 months. Impaired SPORANOX Janssen-Cilag myalgia, headache, malaise, tiredness. renal function (cc Q 50ml/min): Half normal dose. 2MO Q Not recommended. MYCAMINE Astellas Azole antifungal. Itraconazole 100mg. blue/ D Severe renal/hepatic impairment. 2J transparent cap. and pink body, size 0. 15, Pregnancy (unless clearly necessary), lactation. A26.04. B Cholestasis and hepatitis rarely Echinocandin. Micafungin (Na+), 50mg, 100mg. reported. Possible haematological reactions. White compact powder for sln for inf. in vial. S Onychomycosis, systemic mycoses,
208
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
ANTI-INFECTIVES pityriasis versicolor, dermatophytoses, oral candidosis. vulvovaginal candidosis. P Onychomycosis, 200mg once daily for 3 months or 2 pulse treatments for fingernail infections or 3 pulse treatments for toenail infections. A pulse treatment consists of 2 caps. (200mg) twice daily for 7 days. Pulse treatments are separated by a 3-week drug-free interval. Pityriasis versicolor, 200mg once daily for 7 days. Tinea corporis, tinea cruris, 100mg once daily for 2 weeks. Tinea pedis, tinea manuum, 100mg once daily for 4 weeks. Fungal keratitis, 200mg once daily for 3 weeks. Oral candidosis, 100mg once daily for 2 weeks. Vulvovaginal candidosis 200mg twice daily for 1 day or 200mg once daily for 3 days. W Not recommended.
ANTITUBERCULOUS AND 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.
ANTILEPROTIC DRUGS
8.3
VOR50 on reverse. White, cap.-shaped tab. marked Pfizer on one side, VOR200 on reverse. 50mg-28, 200mg-28, A1932.00.
A484.40;
2JN ALSO VFEND INFUSION Voriconazole 200mg. White lyophilised powder in a 30ml clear glass vial. 1 x 30ml, A153.00.
2JN
ALSO VFEND ORAL SUSPENSION Voriconazole 40 mg/ml. White to off white powder for oral suspension. Orange flavoured suspension when reconstituted. 75ml, A760.64. S Treatment of invasive aspergillosis, fluconazole-resistant serious invasive Candida TERBASIL Actavis infections (incl. Candida krusei), serious fungal 2MO infections caused by Scedosporium spp. and Fusarium spp. Admin. primarily to Allylamine antifungal. Terbinafine (HCl) 250mg. 2MO immunocompromised patients with progressive, White scored tab. marked T above and 1 below ALSO SPORANOX ORAL SOLUTION Itraconazole possibly life-threatening infections. score. 28, A30.96. 10mg/ml. Soln. 150ml, A59.80. P Infusion: Loading dose, 6mg/kg 12 S Fungal infections of the skin and nails S Oral and oesophageal candidiasis in caused by Trichophyton, M. canis and E. floccosum hourly (1st 24 hrs); maintenance, 4mg/kg twice HIV-positive or immunocompromised patients. daily. Other: Over 40kg body weight, loading where oral therapy is indicated. Prophylaxis of deep fungal infections anticipated dose, 400mg 12 hourly (1st 24 hrs); maintenance P 1 daily for 2-6 weeks in T. pedis, 2-4 to be itraconazole-susceptible, in patients with 200mg (5ml) twice daily. Under 40kg body weight, weeks in T. cruris, 4 weeks in T. corporis and haematological malignancy or undergoing bone, loading dose 200mg (5ml) 12 hourly (1st 24 hrs); between 6 weeks and 3 months (sometimes 6 marrow transplant and expected to become maintenance 100mg (2.5ml) twice daily. months) for onychomycosis. Impaired renal neutropenic (when standard therapy Q Under 2 years, not recommended. Over function (cc Q 50ml/min): Half dose. inappropriate). 2 years, 7mg/kg twice daily inf. or 200mg (5ml) Q Not recommended. P 200mg once daily or 100mg twice daily D Chronic, active liver disease (avoid). twice daily; Over 12 years, as per adults. for 1 week. Repeat if necessary. In fluconazole D Pregnancy, lactation. Lactation, pregnancy (unless benefit outweighs resistant patients up to 400mg daily may be taken risk). B Inf. related reactions, hepatic toxicity, for 2 weeks and repeated if necessary. monitor hepatic and renal function. Renal adverse B Signs for hepatotoxicity; discontinue W Not recommended. events, dermatological reactions. Proarrhythmic and evaluate liver function. High fever or sore 2NO conditions (caution). Women of child-bearing throat, evaluate for possible haematological potential must use effective contraception. ALSO SPORANOX IV Itraconazole 10mg/ml reaction. + (diluted, 3.33mg/ml). Contains Na . Conc. for soln. C Caution: P450 inhibitors or inducers (eg. Prolonged visual disturbances may occur. Driving/ using machinery. Contains lactose (tab.), sucrose for inf. 25ml, A104.25. cimetidine, rifampicin), CYP2D6 substrates (eg. S Treatment of histoplasmosis. Systemic (oral soln.). TCAs, b-blockers, SSRIs, antiarrhythmics class IC, aspergillosis, candidosis, cryptococcosis (incl. MAO-Is Type B), caffeine, desipramine, ciclosporin. C Contra: Tefenadine, astemizole, st cryptococcal meningitis) when 1 -line therapy A Headache, GI disorders, rash, urticaria, cisapride, pimozide, quinidine, rifampicin, inappropriate. arthralgia, myalgia. carbamazepine, phenobarbital, ergot alkaloids P Loading: 200mg as 1-hour inf. Initial (ergotamine, dihydroergotamine), Rowex sirolimus,efavirenz, ritonavir (r400mg twice daily). loading dose, twice daily (2 days); then once daily; TERNAF max. 14 days. Renal impairment: Moderate, Caution: Astemizole, cyclosporin, tacrolimus, 2MO consider dose adjustment; severe, not warfarin, oral anticoagulants, sulphonylureas, Allylamine antifungal. Terbinafine 250mg (as recommended. statins, benzodiazepines, vinca alkaloids, terbinafine HCl). White, round, scored, convex R If benefit outweighs risk. phenytoin, rifabutin, methadone, omeprazole, HIV 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), nonrisk. NRTIs. tinea cruris and tinea pedis. Onychomycosis (nail D Pregnancy-contraception must be used A Headache, asthenia, flu syndrome, back/ infections) caused by dermatophytes. during, and for one menstrual cycle after chest pain, oedema, hypotension, phlebitis, GI P 250mg once daily. Skin infections: 2-4 treatment. Lactation. disorders, elevated liver function, jaundice, weeks. Tinea pedis, may be up to 6 weeks. B CHF or history of: Use only if benefit cheilitis, gastroenteritis, haemic and lymphatic Onychomycosis: 6 weeks-3 months. Toenail outweighs risks. CHF risk increases with total daily disorders, haematuria, hypokalaemia, creatinine infections, usually 3 months; sometimes 6 months dose. Transient LV ejection fraction may occur. increased, hypoglycaemia, dizziness, hallucinations, or longer. Impaired renal function (ccQ50ml/min): Caution: Hepatic, renal impairment. Monitor liver confusion, depression, anxiety, tremor, Half dose. function, patient should report signs of hepatitis; paraesthesia, respiratory distress syndrome, Q Under 18 years, not recommended. if occurs stop immediately. Discontinue if sinusitis, skin reactions, alopecia, visual D Severe hepatic/renal impairment. neuropathy occurs. Oral solution not disturbances (incl. blurred vision chromatopsia and recommended for severe neutropenia. Transient or Pregnancy (unless essential), lactation. photophobia), acute kidney failure, altered taste B Chronic/active liver disease (not permanent hearing loss may occur. Not perception (oral soln.). recommended). Cholestasis, hepatitis may occur. recommended: Fructose intolerance, glucosePsoriasis. Cutaneous disorders. Discontinue if high galactose malabsorption, sucrase-isomaltase 8.3 ANTITUBERCULOUS AND fever or sore throat. insufficiency. C Caution: CYP2D6 substrates with narrow ANTILEPROTIC DRUGS C Contraindicated: Astemizole, bepridil, therapeutic window, eg. metoprolol, cisapride, dofetilide, levacetylmethadol RIFADIN sanofi-aventis antiarrhythmics. Cytochrome P450 inducers (eg. (levomethadyl), mizolastine, pimozide, quinidine, rifampicin). 2NO sertindole, terfenadine, CYP3A4 metabolized A Decreased appetite, headache, GI Rifamycin. Rifampicin 150mg, 300mg Resp. blue/ HMG-CoA reductase inhibitors (e.g. atorvastatin, red cap and red cap. 150mg-100, A22.16; 300mglovastatin, simvastatin), triazolam, oral midazolam, disorders, rash, urticaria. A44.32. 100, 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 metabolised calcium channel blockers (e.g. Triazole antimycotic. Voriconazole 200mg, 50mg. dihydropyridines, verapamil), oral anticoagulants, White, round tab. marked Pfizer on one side, S Tuberculosis. Certain mycobacterial AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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8.4 ANTIMALARIAL
ANTI-INFECTIVES
DRUGS
infections. Gram positive organisms. N. gonorrhoea. P 450-600mg daily (10mg/kg). Impaired liver function, 8mg/kg. All as a single dose 30 min before or 2 hrs after food. Q 10-20 mg/kg daily (max. 600mg) as a single dose. Under 2 yrs, not recommended. D Jaundice. Concurrent use with saquinavir/ritonavir combination. B Impaired liver function, hyperbilirubinaemia. Hypersensitivity and anaphylaxis (avoid dosage interruption). Elderly. Malnourished. Porphyria. Reddish colouration of tears, urine, sweat and sputum. Pregnancy, lactation. C All drugs metabolised by cytochrome P450 enzyme system, especially CYP 3A4. Others: atovaquone, antacids, certain contrast media, enalapril, halothane, isoniazid, ketoconazole, oral contraceptives, p-aminosalicyclic acid. A Skin reactions. GI reactions incl. pseudomembranous colitis. Hepatitis. Thrombocytopenia. Cerebral haemorrhage. Eosinophilia, leucopenia. Oedema, muscle weakness, myopathy, acute haemolytic anaemia. Flu syndrome, shortness of breath/wheezing, hypotension and shock. Acute renal failure. Disturbances of menstrual cycle.
Rifamycin/isonicotinic acid. ’150’-rifampicin 150mg, isoniazid 100mg; pink tab. coded RH 150. ’300’rifampicin 300mg, isoniazid 150mg. Orange oblong tab. coded RH300. ’150’-84, A19.22; ’300’56, A25.44. S Tuberculosis and other mycobacterial infections. P 450-600mg rifampicin (10mg/kg) daily combined with 5mg/kg isoniazid. Impaired liver function: 8mg/kg/day. All as a single dose 30 mins. before or 2 hrs after food. Q Not recommended. D Jaundice. Concurrent use with saquinavir/ritonavir combination or paraaminosalicyclic acid. Psychosis. B Impaired renal or hepatic function. Chronic alcoholism. Hyperbilirubinaemia. Hepatitis. Immunological reactions with intermittent or interrupted therapy. Elderly. Slow aceylators. Malnourished. Porphyria. Convulsion disorders. 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, carbamazepine, certain contrast media, enalapril, halothane, isoniazid, ketoconazole, oral contraceptives, phenytoin. A Skin reactions. GI reactions incl. RIFATER sanofi-aventis pseudomembranous colitis. Thrombocytopenia. Cerebral haemorrhage. Eosinophilia, leucopenia, 2NO agranulocytosis. Oedema, muscle weakness, Isonicotinic acid deriv./nicotinic acid deriv./ myopathy, acute haemolytic anaemia. Flu rifamycin. Isoniazid 50mg, pyrazinamide 300mg, syndrome, shortness of breath/wheezing, rifampicin 120mg Light pink sug-ctd tab. 100, hypotension and shock. Acute renal failure. A25.49. Pancreatitis, nausea, vomiting. Pellagra, systemic S Treatment of pulmonary tuberculosis. lupus erythematosus-like syndrome. Polyneuritis P Over 65kg, 6 tablets daily; 50-64kg, 5 and other neurotoxic effects. Disturbances of daily; 40-49kg, 4 daily; under 40kg, 3 daily. Single menstrual cycle. daily dose 1-2 hrs before a meal for 2 months. Q Not recommended. 8.4 ANTIMALARIAL DRUGS D Jaundice and hepatic disease. Concurrent use with saquinavir/ritonavir BY-MYCIN Ergha combination. Pregnancy, lactation. 2NO B Impaired liver function, Tetracycline. Doxycycline (hyclate) 100mg. Opaque hyperbilirubinaemia, hepatitis. Elderly or dark blue/white cap. 8, A3.12. malnourished patients. Slow aceylators. S Prophylaxis and treatment of Anaphylaxis (avoid dosage interruption). Gout. chloroquine-resistant falciparum malaria. Renal insufficiency. Diabetes mellitus, alcoholism, P Treatment: 200mg daily for at least 7 convulsive disorders, manic or hypomanic days in conjunction with a rapid-acting psychosis. Haemoptysis. Reddish colouration of schizonticide (e.g. quinine). Prophylaxis: 100mg tears, urine, sweat and sputum. Tyramine and daily 1-2 days before travelling to malarious area. histamine containing foods. Pregnancy, lactation. Continue during travel and for 4 weeks thereafter. C All drugs metabolised by cytochrome Q Not recommended. P450 enzyme system, especially CYP 3A4. Others: D Pregnancy, lactation. Obstructive atovaquone, antacids, certain contrast media, oesophageal disorders. enalapril, halothane, ketoconazole, oral B Hepatic impairment. Oesophageal reflux contraceptives, p-aminosalicyclic acid. disorders. Take with plenty of water and remain A Skin reactions. Gastrointestinal upright. Prolonged use. reactions, including Pseudomembranous colitis. C Penicillin (avoid), methoxyflurane (fatal Thrombocytopenia. Cerebral haemorrhage. renal toxicity). Antacids, Ca++, iron, coumarin Eosinophilia, leucopenia, agranulocytosis. Oedema, anticoagulants, barbiturates, carbamazepine, muscle weakness, myopathy, acute haemolytic phenytoin. anaemia. Flu syndrome, shortness of breath/ A Tooth discolouration, enamel wheezing, hypotension and shock. Acute renal hypoplasia, GI disturbances, oesophagitis, allergic failure. Arthralagia. Anorexia, nausea, vomiting. reactions, photosensitivity, superinfections. Aggravation of peptic ulcer. Fever. Polyneuritis Roche and other neurotoxic effects. Rash, acne, Stevens- LARIAM Johnson syndrome, exfoliative dermatitis, 2MO pemphigoid reactions, pellagra, systemic lupus 4-aminoquinoline. Mefloquine (HCl) 250mg. erythematosus-like syndrome, sideroblastic Quarter scored white tab. 8, A16.13. anaemia. Disturbances of menstrual cycle. S Therapy and prophylaxis of malaria. Especially P. falciparum malaria resistant to other RIFINAH sanofi-aventis antimalarial agents. 2NO V Prophylaxis: Over 45kg, 1 tab. weekly
210
started at least 1 week and up to 2-3 weeks before travel; 31-45 kg, x tab; 20-30 kg, v tab. 519 kg, t tab; under 5 kg, not recommended. Continue during travel and 4 weeks after (min. 6 weeks). Max. 12 months. Treatment based on body weight (see SPC). D When for prophylaxis: Renal or hepatic impairment, history of psychiatric disturbances or convulsions, pregnancy, lactation. B Contraceptive measures should be taken by women of child-bearing age during therapy and for 3 months after. Epilepsy (increased risk of convulsions). Cardiac conduction disorders. C Delay admin. for at least 12 hours after quinine or related compounds. Na+ valproate, typhoid vaccination. A Nausea, vomiting, GI upset, loss of appetite, rarely headache, dizziness, alertness may be impaired, loss of balance, somnolence, sleep disorders. Depression, anxiety, confusion, hallucinations, panic attacks-seek medical advice before next dose. Bradycardia, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome; discontinue immediately).
MALARONE
GSK
2NO Blood schizonticide. Atovaquone 250mg, proguanil (HCl) 100mg. Round, biconvex, pink film-ctd tab. 12, A29.22. S Prophylaxis of P. falciparum malaria. Treatment of acute, uncomplicated P. falciparum 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 recommended for prophylaxis. Treatment: 4 as single dose for 3 consecutive days. Q Treatment: 11-20kg, 1 daily for 3 consecutive days; 21-30kg, 2 as single dose for 3 consecutive days; 31-40kg, 3 as single dose for 3 consecutive days; q 40kg, as per adults; Q11kg, not recommended. D Prophylaxis if severe renal impairment (ccQ30ml/min). Lactation. B Acute malaria with diarrhoea or vomiting, severe renal impairment; consider alternative for treatment. Severe allergic reactions reported. Driving/using machines. Pregnancy (if benefit outweighs risk). C Avoid rifampicin or rifabutin. Caution: Indinavir, metoclopramide, tetracycline, coumarin anticoagulants. A Anaemia, neutropenia, allergic reactions (rash), hyponatraemia, anorexia, abnormal dreams, depression, headache, insomnia, dizziness, GI disorders, elevated liver enzymes, fever, cough.
QUININE SULPHATE
Actavis
2MO Blood schizontocide. Quinine sulphate 300mg. White, circular sug-ctd tab. marked QD and C on one side. 28, A8.41. S Malignant tertian malaria, incl. treatment of chloroquine-resistant malaria. P 600mg eight hourly for 7 days. Q Under 12 years, 10mg/kg BW eight hourly for 7 days. D Red blood cell enzyme deficiencies, Hburia, optic neuritis, tinnitus, fructose intolerance, glucose-galactose malabsorption or
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
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
211
8.5 ANTHELMINTIC
sucrase-isomaltase insufficiency. B Caution: Atrial fibrillation or other serious heart disease, myasthenia gravis, glucose-6phospate dehydrogenase deficiency, inadequately control malarial infection. Driving, operating machinery. Pregnancy, lactation. C Amiodarone, flecainide, quinidine, anticoagulants, terfenadine, other anti-malarial (chloroquine, artemether with lumefantrine, mefloquine), pimozide or thioridazine, cardiac glycosides, cimetidine. A Blood disorders, hypersensitivity reactions, acute renal failure, hypoglycaemia, cardiovascular effects, cinchonism (tinnitus, headache, nausea, abdominal pain, flushing, rash, visual disturbance, confusion), muscle weakness, deafness, vomiting, pruritis, excitement.
VIBRAMYCIN
Pfizer
2NO Tetracycline. Doxycycline (HCl) 50mg, 100mg. Green cap. marked PFIZER and Vibracina. 50mg-28, A6.01; 100mg-8, A3.26; 100mg-12, A4.89. S Chloroquine-resistant falciparum malaria. P Treatment: 200mg daily for at least 7 days in conjonction with rapid-acting schizonticide such as quinine. Prophylaxis: 100mg daily in adults. Can begin 1-2 days before travel to malarious areas; continue daily during travel and for 4 weeks thereafter. Q Under 12 years, contraindicated. 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.
8.5 ANTHELMINTIC AND AMOEBICIDE DRUGS
FLAGYL
sanofi-aventis
2MO Nitromidazole. Anti-protozoal. Amoebicide. Metronidazole 200mg, 400mg Off-white film-ctd tab. and off-white cap. shaped film-coated tab. Both marked with name and strength. 200mg-21, A1.66; 250, A19.65; 400mg-14, A2.35; 100, A16.75.
2MO ALSO FLAGYL-S ORAL SUSPENSION Metronidazole benzoate 200mg/5ml. Susp. 100ml, A6.17. S Infections due to E. histolytica or G. lamblia (including carrier states). P E. histolytica: 1200-2400mg daily in 3 divided doses for 5-10 days. G. lamblia: 2000mg once daily for 3 days. Q E. histolytica: Over 10 years, as adult. 710 years, 600-1200mg daily in 3 divided doses. 3-7 years, 400-800mg daily in 4 divided doses. 1-3 years, 300-600mg daily in 3 divided doses. All for 5-10 days. G. lamblia: Over 10 years, as per adult. 7-10 years, 1000mg once daily. 3-7 years, 600mg once daily. 1-3 years, 400-500mg once daily. All for 3 days. D Active or chronic severe Peripheral and Central Nervous System diseases. B Peripheral or central neuropathy. Leucopenia. Transient epileptiform seizures.
212
ANTI-INFECTIVES
AND AMOEBICIDE DRUGS
multiple protease inhibitors. Only for patients with no other therapeutic options. Q Under 2 years, not recommended. 2-12 years: 375mg/m2 co-administered with 150mg/m2 ritonavir, twice daily. Max dose 500mg/200mg. See SPC. D Moderate or severe hepatic impairment. B Monitor hepatic tests prior to therapy, after 2, 4 and then every 4 weeks until 24 weeks, and every 8-12 weeks thereafter. Mild hepatic impairment, chronic hepatitis B or C (use only if benefits outweigh risks), elevated ASAT and ALAT METRONIDE Clonmel levels, other liver disease; increase monitoring. ASAT/ALAT q 5X ULN, do not initiate; if q10X 2MO ULN, discontinue. Risk of clinical hepatitis and Amoebicide. Metronidazole 200mg. White scored hepatic decompensation. Caution: Elderly, tab. coded MZL 200 and white scored tab. coded MZL 400. Both marked with twin triangle logo on haemophiliacs, patients at risk of increased bleeding. Risk of lipodystrophy, osteonecrosis, reverse. 200mg-21, A1.62. diabetes mellitus, hyperglycaemia or exacerbations S All forms of amoebiasis. of existing diabetes mellitus, immune reaction P 1200-2400mg daily in 3 divided doses. syndrome. Hepatic, triglyceride and cholesterol Q 1-3 years, 300-600mg daily in three testing, prior to treatment and regularly divided doses; 3-7 years, 400-800mg daily in four thereafter. Rashes may occur. Patients using divided doses, 7-10 years, 600-1200mg daily in oestrogens as HRT, monitor for oestrogen three divided doses, over 10 years, as for adults. deficiency. Tab. contain sorbitol and small amount Treatment is usually continued for 5-10 days. of alcohol. B Pregnancy, lactation, liver disease. C Contra: Rifampicin, St Johnâ&#x20AC;&#x2122;s wort, C Alcohol, oral anticoagulants and substances highly dependent on CYP3A/CYP2D6 phenobarbitone. Cimetidine, lithium. for clearance such as antiarrhythmics, A GI distress, furred tongue, unpleasant antihistamines, ergot derivatives, GI motility taste. Urticaria, angioedema, CNS disturbances, dark urine. Neuropathy, epileptiform seizures and agents, neuroleptics, sedatives/hypnotics, simvastatin, lovastatin. Not recommended: leucopenia on long term therapy. Zidovudine, abacavir, halofantrine, lumefantrine, VERMOX McNeil Healthcare fluticasone or other glucocorticoids that are metabolised by CYP3A4, atorvastatin, omeprazole, 2O esomeprazole other PPIs.Caution: carbamazepine, Anthelmintic. Mebendazole 100mg/5ml. Susp. phenobarbital, and phenytoin. See SPC 30ml, A2.11. A Hypertriglyceridaemia, hyperlipidaemia, 2OY anorexia, headache, GI disorders, rash, pruritus, ALSO VERMOX TABLETS Mebendazole 100mg. fatigue. Faintly orange, circular tab. marked ME100 one side, Janssen on reverse. 6, A1.83. ATRIPLA Gilead/BMS S GI infestations caused by nematodes 2J and cestodes. Combination antiretroviral. Efavirenz 600mg, P Ascariasis, trichuriasis, ankylostomiasis, emtricitabine 200mg, tenofovir disoproxil (as mixed infections: 100mg twice daily for 3 days. fumarate) 245mg. Pink, capsule shaped, film-ctd Enterobiasis: Single 100mg dose repeated at 2-4 tablet, marked 123. 30, A1028.02. weeks. Taeniasis, strongyloidiasis: 200mg twice S HIV-1 infection in adults with virologic daily for 3 days. suppression to HIV-1 RNA levels Q 50 copies/ml Q Under 2 years, not recommended. Over for over 3months. 2 years, as per adult except taeniasis, P 1 tab. once daily on empty stomach, at strongyloidiasis: 100mg twice daily for 3 days. bedtime. Co-administration with rifampicin: Add D Pregnancy, lactation. 200mg/day (800mg total) efavirenz. ModerateB High parasitic burdens. severe renal impairment (cc Q50ml/min): Not C Metronidazole. Caution: Cimetidine. recommended. Q Under 18 years, not recommended. 8.6 ANTIVIRAL DRUGS D Severe hepatic impairment (CPT grade APTIVUS Boehringer Ing. C). Pregnancy (unless clearly necessary), lactation. B Risk of lactic acidosis (discontinue if 2JN symptomatic hyperlactataemia and metabolic/lactic Protease inhibitor. Tipranavir 250mg. Pink cap. acidosis, progressive hepatomegaly, or rapidly marked TPV 250. 120, A725.00. elevating aminotransferase levels occur). Caution: S Co-administered with low dose Mild-to-moderate liver disease, pre-existing liver ritonavir, HIV-1 infection in highly pre-treated dysfunction incl. chronic active hepatitis, chronic adults with virus resistant to multiple protease HBV or HCV co-infection (increased risk of serious inhibitors. hepatic reactions), history of seizures. Prior history P 500mg (taken with 200mg ritonavir) of psychiatric disorders. Reported: Renal failure/ twice daily with food. impairment, elevated creatinine, Q Not recommended. hypophosphataemia and proximal tubulopathy; 2JN monitor renal function. Discontinue if severe rash ALSO APTIVUS ORAL SOLUTION Tipranavir associated with blistering, desquamation, mucosal 100mg/ml. Clear yellow viscous liquid. A229.59. involvement or fever occurs. May occur: Mitochondrial dysfunction in child exposed in S Co-administered with low dose utero and/or postnatally, liposdystrophy, immune ritonavir, HIV-1 infection in highly pre-treated reactivation syndrome, osteonecrosis. Contains children from 2-12 years with virus resistant to 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. A GI distress, furred tongue, unpleasant taste. Rash, urticaria, flushing, angioedema, CNS disturbances, headache, dizziness, confusion, hallucinations, vision and blood disorders.
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
ANTIVIRAL DRUGS 8.6
Na+. C Contra: Terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, ergot alkaloids St. John’s wort, voriconazole, cytidine analogues (e.g. lamivudine), adefovir dipivoxil. Not recommended: Atazanavir/ritonavir, didanosine, renally eliminated drugs (e.g. cidofovir), nephrotoxic drugs (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, interleukin2). See SPC. A Anorexia, nightmare, depression, depressed mood, anxiety, insomnia, mood altered, abnormal dreams, sleep disorder, dizziness, somnolence, headache, hot flush, GI disorders, rash, night sweats, increased blood creatinine, fatigue, increased energy.
BARACLUDE
BMS
2NT Nucleoside analogue. Entecavir (as monohydrate) 0.5mg, 1mg. White/pink triangular-shaped film-ctd tab. with BMS debossed on one side and 1611/ 1612 resp. on the other. Price on request.
2NT ALSO BARACLUDE ORAL SOLUTION Entecavir (as monohydrate) 0.05mg/ml. Oral sln. Price available on request. S Chronic hepatitis B virus (HBV) infection in adults with compensated liver disease and evidence of active viral replication, persistently 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.
BELLVIRAX
Ranbaxy
2MO Herpes-specific enzyme inhibitor. Aciclovir 200mg, 800mg. Cap.-shaped biconvex uncoated white to off-white tab. with strength embossed one side
and ACV the other. 200mg-25, A21.50; 800mg-35, A65.43. S Treatment of herpes simplex virus infections involving skin and mucous membranes, incl. initial and recurrent genital herpes. Suppression of recurrence of herpes simplex infections in immunocompetent patients. Prophylaxis against herpes simplex infections in immunocompromised individuals. Treatment of herpes zoster (shingles) and varicella (chicken pox) infections. P Herpes simplex infections: 200mg 5 times/day at 4-hourly intervals, omitting night-time dose, for 5 days. Can be extended, depending on severity. May be increased to 400mg in severely immunocompromised patients or patients with malabsorption. Renal impairment, ccQ10ml/min, max 200mg twice daily at 12-hourly interval. Suppression of recurrent herpes simplex infections in immunocompetent patients: 200mg, 4 times/day at 6-hourly intervals or 400mg twice daily at 12hourly intervals. May be reduced to 200mg, 3 times daily at 8-hourly intervals or twice daily at 12-hourly intervals. 800mg/day or less may be associated with breakthrough viral infection. Stop treatment temporarily after 6-12 months to assess patient. Prophylaxis of herpes simplex infections in immunocompromised individuals: 200mg, 4 times daily at 6-hourly intervals. May be increased to 400mg in patients with severe immune system impairment or impaired GI absorption. Consider IV dose as alternative. Herpes zoster and varicella infections: 800mg, 5 times daily at 4-hourly 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).
patients infected with only CCR5-tropic HIV-1 detectable. P 150mg, 300mg or 600mg twice daily depending on co-administrated antiretrovirals and other medicinal products (see SPC). Q Not recommended. D Peanut and soy allergies. Pregnancy (unless benefit outweighs risk), lactation. B Use when only CCR5-tropic HIV-1 is detectable (i.e. CXCR4 or dual/mixed tropic virus not detected) as determined by tropism test on newly drawn blood sample. Consider discontinuation in patients with symptoms of acute hepatitis, particularly with suspected drugrelated hypersensitivity or with increased liver transaminases combined with rash or other systemic symptoms of hypersensitivity. Monitor patients with pre-existing liver dysfunction. Renal impairment, dose adjustment only recommended in patients receiving potent CYP3A4 inhibitors (see SPC). Caution: Hepatitis B/C co-infection, severe CVD, patients with history of postural hypotension or on concomitant drugs known to lower BP. Osteonecrosis, immune reconstitution syndrome may occur. C Avoid St John’s wort, rifampicin with efavirenz. Caution: CYP3A4 inhibitors/ inducers (see SPC). A Headaches, nausea, GI disorders, weight decrease, dizziness, paraesthesia, dysgeusia, somnolence, cough, rash, pruritus, muscle spasms, back pain, asthenia, insomnia. Increased ALT, AST, gamma-glutamyl transferase.
CELSENTRI
Nucleoside analogue. Ribavirin 200mg, 400mg.
2J
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
Pfizer Resp. light pink or reddish brown flat oval film-ctd
CCR5 antagonist. Maraviroc 150mg, 300mg. Blue, biconvex, oval film-ctd tabs marked Pfizer and MVC150 or MVC300 resp. 60, A966. S In combination with other antiretrovirals in treatment-experienced adult
tab. marked RIB 200 or 400 one side, ROCHE on 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
213
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
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 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.
syndrome. Contains lactose. C Contra: CYP3A4 substrates with narrow therapeutic window, amiodarone, terfenadine, cisapride, astemizole, alprazolam, triazolam, oral midazolam, pimozide, ergot derivatives, simvastatin or lovastatin, rifampicin, St Johnâ&#x20AC;&#x2122;s wort. Contra with ritonavir: Alfuzosin, meperidine, piroxicam, propoxyphene, bepridil, encainide, flecanide, propafenone, quinidine, fusidic acid, clozapine, clorazepate, diazepam, estazolam and flurazepam. Caution: Other inducers/inhibitors or substrates of CYP3A4. See SPC. A Headache, dizziness, GI disturbances, skin disturbances, nephrolithiasis. Insomnia, hypoaesthesia, parasthesia, myalgia, dysuria. Lipodystrophy, asthenia/fatigue, taste perversion, hepatic disorders, renal failure, hypersensitivity reactions. Pyelonephritis, renal insufficiency.
CYMEVENE
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.
2JN
Nucleoside analogue. Ganciclovir 500mg. Powder in vial. 5, A234.34. S Treatment of life-threatening or sightthreatening cytomegalovirus (CMV) infections in immunocompromised individuals. These states might include acquired immunodeficiency syndrome (AIDS), iatrogenic immunosuppression associated with organ transplantation, or chemotherapy for neoplasia. Prevention of CMV infection in patients on immunosuppressive therapy following organ transplantation. P Treatment: initially 5mg/kg IV over 1 hour every 12 hours for 14-21 days. Long term IV 6mg/kg daily for 5 days or 5mg/kg daily for 7 days. Prevention: initially 5mg/kg IV 12 hourly for 7-14 days, 6mg/kg daily for 5 days or 5mg/kg daily for 7 days. For doses in renal impairment see SmPC. D Hypersensitivity to acyclovir. Pregnancy, lactation. B Contraceptive measures should be taken by women of child-bearing age during therapy and males advised to practice barrier contraception during and for at least 90 days following therapy. Renal impairment ensure adequate hydration during IV admin. Limited experience in children, potential for long-term carcinogenicity and reproductive toxicity. C See SPC A GI upset, mouth ulceration, anorexia, dyspnoea, pruritus, rash, fever, headache, CRIXIVAN MSD infections, malaise, photosensitivity reaction, arrhythmias, hypertension, hypotension, anxiety, 2JN ataxia, confusion, depression, abnormal liver Protease inhibitor. Indinavir 200mg, 400mg. White function tests, pancreatitis. caps. marked with name and strength. 200mg-360, A322.96; 400mg-180, A322.96. EMTRIVA Gilead S In combination with antiretroviral 2MT nucleoside analogues for the treatment of HIV-1 NRTI. Emtricitabine 200mg. Hard opaque cap. with infected patients. white body and light blue cap, printed with P 800mg every 8 hours swallowed whole 200mg on cap and GILEAD and Gilead logo on with water 1 hour before or 2 hours after food. body. 30, A276.59. Mild to moderate hepatic impairment due to S HIV-1 infection in adults and children in cirrhosis: 600mg every 8 hours. combination with other antiretroviral agents. Q Under 4 years not recommended; 4-17 2 P 1 daily. Renal insufficiency (cc Q50ml/ years 500mg/m eight hourly. min): Dose interval adjustment required. D Pregnancy, lactation. See Drug-Int. B Nephrolithiasis, interstitial nephritis with R As for adults. Q Over 4 months and over 33kg, as for medullary calcification and cortical atrophy adults. Under 4 months, not recommended. (ensure adequate hydration, interrupt or 2MT discontinue therapy in acute episodes), acute ALSO EMTRIVA ORAL SOLUTION Emtricitabine haemolytic anaemia, diabetes mellitus, increased 10mg/ml. 170ml, A76.88. bleeding in haemophiliac patients, osteonecrosis. Renal or hepatic impairment. Immune reactivation P 240mg (24ml) once daily.
214
EPIVIR
GSK
2JN NRTI. Lamivudine 150mg, 300mg. Film-ctd diamond-shaped tabs. 150mg, white marked GX CJ7. 300mg, grey marked GX EJ7. 150mg-60, A207.83; 300mg-30, A207.83.
2JN ALSO EPIVIR ORAL SOLUTION Lamivudine 10mg/ ml. 240ml, A55.45. S Part of antiretroviral combination therapy for HIV infected adults and children. P 150mg twice daily or 300mg once daily. Q Under 3 months, not recommended; 3 months-12 years 4mg/kg body weight daily. Max. 300mg daily. D Lactation. B Renal impairment, hepatitis, co-infection with hepatitis C. Discontinue if symptomatic hyperlactatemia and metabolic acidosis, progressive hepatomegaly, or elevating aminotransferase levels occur. Monitor liver function tests. C Other lamivudine or emtricitabine containing drugs, co-trimoxazole (avoid). Caution: Trimethoprim, sulfamethoxazole. A Headache, insomnia, cough, nasal symptoms, nausea, GI disorders, rash, alopecia, arthralgia, muscle disorders, fatigue, malaise, fever.
FAMCICLOVIR TEVA
Teva
2NO Nucleoside analogue. Famciclovir 125mg, 250mg. White to off-white, round, film-ctd tabs marked 93 on one side and 8117 or 8118 resp. on reverse. 125mg-10, A19.01; 250mg-15, A 57.01. S Herpes zoster of the skin and mucous membranes in immunocompetent patients with severe course of infection anticipated, including herpes zoster ophthalmicus. Herpes zoster and herpes simplex in immunocompromised patients. P 500mg three times daily. Herpes zoster: Initiate asap (within 48 hours) of onset of rash; duration 7 days in immunocompetent and 10 days in immunocompromised patients. Herpes simplex: Initiate asap after onset of lesions; duration 7 days. Q Not recommended. B Renal impairment (see SPC).
FAMVIR
Novartis
2NO Nucleoside analogue. Famciclovir 250mg, 750mg.
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 White film-ctd tab. marked FV and 250 on reverse and FAMVIR 750 resp. Shingles treatment pack 250mg-21, A130.40; 750mg-7, A110.84. S Herpes zoster. P 750mg once daily or 250mg three times daily for 7 days. Q Not recommended. B Renal impairment.
ANTIVIRAL DRUGS 8.6 IMMUKIN
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). FUZEON Roche Inj. given SC, preferably in evening, 3 times 2JN weekly. Fusion inhibitor. Enfuvirtide 90mg/ml. Powder in Q Under 6 months, not recommended for vial for soln. 60, A1835.29. CGD. S In combination with other D Hypersensitivity to closely related antiretrovirals for treatment of HIV-1 patients who interferons. failed on regimens containing at least one B Cardiac disease, history of seizures and/ antiretroviral (among PI, NNRTI or nRTI) or are or compromised CNS function, severe renal intolerant to previous antiretroviral regimens. insufficiency. Monitor haematology. Pregnancy, R q65 years, not recommended. lactation. V Under 16 years, see SPC; over 16 years, C Co-admin. with other serum protein/ 90mg twice daily by SC inj. into upper arm, immunological products. anterior thigh or abdomen. A Headache, nausea/vomiting, rash, B Does not reduce risk of HIV transmission myalgia, fever, inj. site reactions. to others. Increased rate of some bacterial infections, pneumonia, hypersensitivity reactions, IMUNOVIR Newport Pharmaceuticals liver disease, chronic hepatitis B and C. Admin. to 2NO non-HIV-1 infected patients may result in false positive HIV test with HIC ELISA test. Severe renal Immunomodulator. Inosine pranobex 500mg. White ovoid tab. 100, A42.68. impairment and patients on dialysis, reduced S Management of patients with hepatic function. Immune reactivation syndrome. immunodepression suffering from viral infections Pregnancy, Lactation. Osteonecrosis. incl. subacute sclerosing panencephalitis (SSPE), A Inj. site reactions, sinusitis, skin varicella and herpes simplex (type I and II). Genital papilloma, flu, ear infection, lymphadenopathy, decreased appetite and weight, anorexia, anxiety, warts, as adjunctive therapy to podophyllin or CO2 laser. nightmare, irritability, peripheral neuropathy, conjuctivitis, pneumonia, GI disorders, pancreatitis, P 50mg/kg of body weight up to a maximum of 4g (usually 2 tabs 3-4 times a day). pruritus and other skin disorders, myalgia, SSPE: 100mg/kg of body weight up to a maximum asthenia, hypertriglyceridaemia, diabetes, of 3-4g continuously with regular monitoring. 3g attention disturbance, tremor, vertigo, nasal daily in divided doses for 28 days. congestion, calculus renal, haematuria. Q Under 1 year, not recommended; over 1 HEPSERA Gilead year, 50-100mg/kg body weight daily in four divided doses; over 12 years, as for adults. 2NT D Patients presently suffering from gout Acyclic nucleotide phosphonate analogue. or elevated uric acid blood levels. Adefovir dipivoxil 10mg (equiv. adefovir 5.45mg). B May be administered with caution in White, round, bevelled-edge tab. marked GILEAD patients with a history of gout, hyperuricaemia, 10 one side and liver shape on reverse. 30, hepatic dysfunction, urolithiasis or in patients with A549.06. impaired renal function. S Chronic hepatitis B in adults with: C Xanthine oxidase inhibitors, (a)Compensated liver disease with evidence of corticosteroids, uricosuric agents. active viral replication, persistently elevated serum A Elevated levels of uric acid. ALT levels and histological evidence of active liver Janssen-Cilag inflammation and fibrosis. (b)Decompensated liver INTELENCE disease. 2JM P 1 once daily. Monitor every 6 months NNRTI. Etravirine 100mg. White to off-white oval for hepatitis B biochemical, virological and tab. debossed with T125 one side and 100 on the serological markers. other. 120, A547.06. Q Under 18 years, not recommended. S Treatment of HIV-1 infection in D Lactation. antiretroviral treatment-experienced adult patients B Monitor normal renal function every 3 in combination with a boosted protease inhibitor months. Dose adjustment necessary if ccQ50ml/ and other antiretroviral medicinal products. min. Cirrhosis. Co-infection with hepatitis C or D, P 200mg twice daily following a meal. HIV. Risk of lactic acidosis, sometimes fatal in Only in combination with other antiretrovirals. patients (particularly obese women) with Q Not recommended. hepatomegaly, hepatitis, or other known risk D Lactation. factors of liver disease. Elderly. Women of childB Decreased virologic response for some bearing potential, use effective contraception. viral strains, see SPC. Not recommended: Severe Pregnancy (if benefit outweighs risk). Monitor for hepatic impairment. Discontinue if severe exacerbations of hepatitis after discontinuation of cutaneous reactions, Stevens-Johnson Syndrome, treatment. severe hypersensitivity syndrome or erythema C Products excreted renally, or which multiforme occur. May also occur: Lipodystrophy, affect renal function (incl. hOAT1). See SPC immune reconstitution syndrome, osteonecrosis. A GI disturbances, asthenia, abdominal Caution: Elderly, moderate hepatic impairment, HBV or HCV co-infection. Contains lactose. pain, headache. Renal disturbances.
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.
INTRONA
Schering-Plough
2NT Single-subtype recombinant interferon. Interferon alpha-2b (rbe) 10 MIU. Powder in vial plus WFI. 1 syringe, 2 needles, 1 cleansing swab. 1, A77.48.
2NT ALSO INTRONA MULTIDOSE VIALS Interferon alfa2b (rbe) 10 MIU/ml (2.5ml). Plus syringe kits containing syringe, needles, sterets and plasters. 10 MIU/ml-1 x 2.5ml, A190.23.
2NT ALSO INTRONA MULTIDOSE INJECTION PENS 18 MIU (15 MIU/ml), A139.47; 30 MIU (25 MIU/ml), A232.44; 60 MIU (50 MIU/ml), A464.88. S Chronic hepatitis B and C, hairy cell and chronic myeloid leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumours, malignant melanoma. V See SPC. D History of severe pre-existing cardiac disease. Severe renal/hepatic dysfunction. Epilepsy, compromised CNS. Chronic hepatitis with decompensated cirrhosis or in patients being or have been treated recently with immunosuppressives excluding short term corticosteroid withdrawal. Autoimmune hepatitis; or history of autoimmune disease; immunosuppressed transplant recipients. Uncontrolled pre-existing thyroid disease. Severe psychiatric conditions (or history of) in children. Pregnancy, lactation. B Caution: History of pulmonary disease, diabetes prone to ketoacidosis, coagulation disorders, severe myelosuppression, psoriasis/ sarcoidosis, patients predisposed to autoimmune disorders, adults with severe psychiatric conditions. 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, tinnitus, vertigo, palpitation, tachycardia, hypertension, weight decrease. See SPC.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
215
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
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 Protease inhibitor. Saquinavir 500mg. Light orange body weight up to a maximum of 3-4g to greyish or brownish orange biconvex film-ctd continuously with regular monitoring. Genital tab. marked ROCHE and SQV 500. 500mg-120, Warts dosage 3g (20ml x 3 times a day) for a total A409.58. of 14-28 days S HIV-1 infections in adults, in Q Under 1 year, not recommended; over 1 combination with ritonavir and other year, 50mg/kg body weight daily in four divided antiretroviral drugs. doses ( 1 tab./10kg up to 20kg); over 12 years, as P 1000mg twice daily (taken with 100mg for adults. ritonavir) in combination with other antiretroviral D Patients presently suffering from gout agents, within 2 hrs of a meal. or elevated uric acid blood levels. R Over 60 years, limited experience. B Renal impairment, gout or Q Under 16 years, limited experience. hyperuricaemia, hepatic dysfunction. Pregnancy, D Severe hepatic impairment. Lactation. lactation. B Severe renal/moderate hepatic C Xanthine oxidase inhibitors, uricosuric impairment, chronic diarrhoea or malabsorption, agents. haemophiliac patients, diabetes mellitus, A Elevated levels of uric acid. hyperglycaemia, hepatitis B/C, cirrhosis; caution. Lipodystrophy, Immune Reactivation Syndrome. KIVEXA GSK Pregnancy (only if essential). Contain lactose. 2JN C Contra: Terfenadine, astemizole, NRTIs. Abacavir (as sulfate) 600mg and lamivudine pimozide, cisapride, amiodarone, propafenone, 300mg. Orange, film-ctd, cap.-shaped tab. marked flecainide, midazolam, triazolam, simvastatin, GS FC2. 30, A591.95. lovastatin, ergot alkaloids, rifampicin, garlic caps. S Antiretroviral combination therapy for Caution: Some other PIs, atorvastatin, oral the treatment of HIV infection. Not for use in contraceptives, substrates/ inhibitors/ inducers of patients carrying the HLA-B*5701 allele, unless no CYP3A4 and/or P-gp, See SPC other therapeutic option available. A GI disorders, headache, peripheral P 1 once daily. neuropathy, numbness extremities, paraesthesia, Q Under 12 years or under 40kg, not dizziness, rash, pruritus, asthenia, fatigue, fever, recommended. pain. D Severe hepatic impairment. Pregnancy, ISENTRESS MSD lactation. B cc Q50ml/min; not recommended. 2N Moderate hepatic impairment, not recommended Integrase strand transfer inhibitor. Raltegravir (as unless judged necessary. Monitor for K+) 400mg. Pink, oval film-ctd tab. marked 227. 60, hypersensitivity reaction symptoms; discontinue A810.00. immediately if occurs. Risk of lactic acidosis. S In combination with other antiCaution with hepatomegaly, hepatitis or other risk retrovirals for HIV-1 infection in adults. factors for liver disease and hepatic steatosis. P 400mg administered twice daily. Lipodystrophy, Immune Reactivation Syndrome, Q Under 16 years, not recommended. opportunistic infections may occur. Child exposed D Pregnancy, lactation. in utero; monitor for signs of mitochondrial B Caution: Severe hepatic impairment, dysfunction. Contain azo colouring agent sunset chronic hepatitis B or C (monitor), elderly. ARTyellow. naive patients. Reported: Osteonecrosis (monitor C Ganciclovir, foscarnet, zalcitabine (not for signs of joint aches), immune reactivation recommended). Caution: Methadone, rifampicin, syndrome (monitor for inflammatory symptoms), phenobarbital, phenytoin, drugs eliminated via myopathy and rhabdomyolysis. Contains lactose. active renal secretion (e.g. trimethoprim), coC Caution: Strong uridine diphosphate trimoxazole, tenofovir. glucuronosyltransferase (UGT) 1A1 inducers, eg A Potentially life-threatening rifampicin (if unavoidable, double Isentress dose); hypersensitivity reaction, anorexia, headache, strong enzyme inducers, eg. phenytoin, insomnia, GI disorders, rash, alopecia, arthralgia, phenobarbital, no data. Avoid drugs increasing muscle disorders, fever, fatigue. gastric pH (eg. PPIs, H2 antagonists). A Dizziness, vertigo, GI disorders, fatigue, PEGASYS Roche asthenia. Stevens Johnson syndrome, rash, 2NT headache, insomnia, abnormal dreams, increased Antiviral/immunomodulator. Peginterferon alfa-2a AST/ALT/triglycerides. 135mcg, 180mcg. 0.5ml soln. in pre-filled syringe. 135mcg-1, A220.29. 180mcg-4, A1021.00. ISOPRINOSINE Newport Pharmaceuticals S HBeAg-positive or HBeAg-negative 2NO chronic hepatitis B. Chronic hepatitis C, incl. Immunomodulator. Inosine pranobex 500mg white patients with compensated cirrhosis, with optimal scored tab. 24, A10.28. use in combination with ribavirin; monotherapy 2NO indicated mainly in case of intolerance or ALSO ISOPRINOSINE SYRUP Inosine pranobex contraindication to ribavirin. 250mg/5ml. Syrup. 120ml, A6.26. P 180mcg once weekly by SC inj. in abdomen or thigh. Hepatitis B: Duration 48 weeks. S Management of patients with Hepatitis C: Duration of combination therapy immunodepression suffering from viral infections depends on viral genotype. Genotype-1, 48 weeks; incl. subacutesclerosing panencephalitis, varicella. Herpes simplex (type I and II) and management of genotype 2/3, 24 weeks. Duration for monotherapy, 48 weeks. End stage renal disease: recurring Herpes simplex (type I and II). The Initially 135mcg. treatment of Genital Warts.
INVIRASE
Roche
2JN
216
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 reactions, asthenia, pain, GI disorders, anorexia, weight loss, myalgia, arthralgia, headache, insomnia, irritability, depression, dizziness, concentration impairment, anxiety, dyspnoea, cough, alopecia, pruritus, dermatitis, dry skin, flulike syndrome, ocular changes.
PREZISTA
Janssen-Cilag
2JM Protease inhibitor. Darunavir (as ethanolate) 75mg, 150mg, 400mg, 600mg. Resp., white capletshaped, white oval-shaped, light orange ovalshaped or orange oval-shaped tab, debossed with strength on one side and TMC on the other side. 75mg-480, A776.47; 150mg-240, A776.47. 400mg60, A625.21; 600mg-60, A776.47. S HIV-1 infection. In antiretroviral therapy (ART) naive adults, co-administered with low dose ritonavir in combination with other antiretrovirals. In treatment-experienced adults and children q 6 years and q20kg, incl. those that have been highly pre-treated, co-administered with low dose ritonavir in combination with other antiretrovirals. P To be taken with food. ART-naive patients: 800mg with 100mg ritonavir once daily. ART-experienced patients: 600mg taken with 100mg ritonavir twice daily. Q ART-naive: Not recommended. ART experienced: r20 kg-Q30 kg: 375mg with 50mg ritonavir twice daily. r30kg-Q40kg: 450mg with 60mg ritonavir twice daily. r40kg: 600mg with 100mg ritonavir twice daily. D Severe hepatic impairment. Lactation. B Caution: Elderly, known sulphonamide allergy, mild/moderate hepatic impairment, chronic hepatitis B or C, haemophiliac patients (increased bleeding risk). May occur: Severe skin rash (may be accompanied by fever and/or transaminases elevations), erythema multiforme and Stevens Johnson syndrome, new onset diabetes mellitus, hyperglycaemia, or exacerbation of existing diabetes mellitus, lipodystrophy, osteonecrosis, immune reactivation syndrome. Pregnancy (use only if benefit outweighs risk). Driving or using machines if dizziness occurs. C Contra: Rifampicin, lopinavir/ritonavir combination, herbal preparations containing St Johnâ&#x20AC;&#x2122;s wort, antiarrhythmics (amiodarone, bepridil, quinidine, systemic lidocaine), antihistamines (astemizole, terfenadine), ergot derivatives (e.g. dihydroergotamine, ergonovine, ergotamine, methylergonovine), GI motility agents (cisapride), neuroleptics (pimozide, sertindole), sedatives/ hypnotics (triazolam, midazolam administered orally and HMG-CoA reductase inhibitors
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 (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.
ANTIVIRAL DRUGS 8.6 cap. marked 100 and Y9C, with company logo and blue securiband. 100mg-100, A140.15.
2JN ALSO RETROVIR TABLETS Zidovudine 300mg. White scored film-ctd tab. marked WELLCOME X4F. 60, A252.27.
2JN
ALSO RETROVIR SYRUP Zidovudine 50mg/5ml. Sugar-free soln. 200ml, A33.47. S Use in combination with other REBETOL Schering-Plough antiretrovir agents (except in pregnancy) for 2NT treatment of HIV infection. Monotherapy in HIVpositive pregnant patients (over 14 weeks Nucleoside analogue. Ribavirin 200mg. Opaque gestation) and their newborn infants. white hard cap. marked with blue ink. 84, A466.69; 140, A777.83; 168, A933.40. P In combination, 500-600mg daily in 2-3 divided doses. Pregnant women, see SPC. 2NT Q Under 3 months, see lit. 3 months-12 ALSO REBETOL ORAL SOLUTION Ribavirin 40mg/ years, 360-480mg/m2 daily in 3-4 divided doses in ml. Clear, colourless to pale or light yellow oral combination with other agents. soln. S Chronic hepatitis C in combination with 2 J N peginterferon a-2b (adults previously untreated or ALSO RETROVIR IV Zidovudine 200mg/20ml. Soln. for inf. Vial-5 x 20ml, A81.42. who failed previous a-interferon therapy (caps S Use only when oral treatment is not only)) or interferon a-2b (previously untreated possible. adults and children). Do not use monotherapy. P Dilute prior to admin. 1-2mg/kg body P Q65kg, 800mg daily divided into 2 in weight every 4 hours. See SPC. the morning and 2 in the evening; 65-85kg, Q 80-160mg/m2 every 6 hours. See lit. 1000mg daily divided 2 morning and 3 evening; D Low neutrophil cell counts (Q 0.75 x 86-105kg 1200mg daily divided 3 morning and 3 evening. q105kg 1400mg daily divided 3 morning 109/L) or low Hb levels (Q7.5g/decilitre). Newborn and 4 evening. Duration depends on drug used in infants with hyperbilirubinaemia. Lactation. B Perform blood tests at least every 2 combination and patient genotype (see SPC). weeks for the first 3 months of therapy and at Dosage modification guidelines (see SPC). least monthly thereafter. Adjust dose if anaemia Q Adolescents, children over 3 years: Ribavirin 15mg/kg/day + interferon a-2b 3 MIU/m2 or myelosuppression occurs or is present. Renal or 3 times a week. Genotype 1: 1 year; genotype 2, 3: hepatic impairment. Elderly. Pregnancy. C Chronic admin. of analgesics, 24 weeks. particularly paracetamol. Drugs affecting hepatic D Cardiac disease, haemoglobinopathies (eg. thalassemia, sickle-cell anaemia), chronic renal glucuronidation or inhibiting hepatic microsomal enzymes. Other potentially nephrotoxic or failure, ccQ50ml/min, haemodialysis, severe psychiatric conditions, severe hepatic dysfunction, myelosuppressive drugs. Probenecid, valproic acid, fluconazole, methadone, ribavirin, stavudine. liver cirrhosis, autoimmune disease, thyroid disease. Lactation. Pregnancy: Negative pregnancy Caution patients about concomitant use of selfadministered drugs. test then effective contraceptive up to 4 months A Anaemia, neutropenia, leucopenia. after treatment for female patients, and up to 7 Nausea, headache, rash, abdominal pain, fever, months after treatment for male patients and paraesthesia, anorexia, myalgia, insomnia. female partners. Men whose partners are pregnant must use a condom to minimise delivery REYATAZ BMS of ribavirin to partner. Perform routine monthly pregnancy tests. 2JN B Assess cardiac status at start. Monitor Protease inhibitor. Atazanavir (as sulphate) 150mg, liver function, haematological values and blood 200mg, 300mg. Hard, opaque blue (150, 200mg) chemistry before, at 2 and 4 weeks, and or red and blue (300mg) caps. printed with BMS periodically thereafter. CHF, MI, arrhythmias; 150, 200 or 300 on one half and 3624, 3631 or perform ECG prior and during therapy. Renal 3622 resp. on other half. 150mg-60, A575.15; impairment; monitor for anaemia. HIV-positive 200mg-60, A602.81; 300mg-30, price on request. subjects. Withdraw if acute hypersensitivity S Treatment of HIV-1 infected adults, in reactions develop. Potential risk of dose reduction. combination with other antiretrovirals. Gout. Dental disorder. Monitor for CNS effects, P 300mg once daily taken with ritonavir particularly depression and suicidal ideation. 100mg once daily and with food. Growth; monitor thyroid every 3 months (children, Q Children and adolescents, not adolescents). Contains lactose. recommended. C Antacids, nucleoside analogues D Moderate to severe hepatic (caution). Didanosine not recommended. insufficiency. Lactation. A Viral infection, pharyngitis, rhinitis, B Mild hepatic insufficiency, chronic anaemia, haemolysis, neutropenia, hepatitis, liver dysfunction; discontinue if hypothyroidism, anorexia, weight decrease, condition worsens. Conduction problems (2nd depression, insomnia, anxiety, dry mouth, degree or higher atrioventricular or complex headache, dizziness, cough, dyspnoea, myalgia, bundle-branch block), haemophiliac patients, arthralgia, musculoskeletal pain, flu-like symptoms, nephrolithiasis, diabetes, bradycardia, long asthenia, inj. site reaction. congenital QT, electrolyte imbalances. Inflammatory reaction (immune reactivation RETROVIR GSK syndrome) may arise. Contains lactose. Risk of 2JN hyperbilirubinemia. Osteonecrosis has been Nucleoside analogue. Zidovudine 100mg. White reported. Not recommended in patients
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.
ROFERON-A
Roche
2NT Single-subtype recombinant. Interferon alfa-2a (rbe) 3, 4.5, 6, and 9 mega units. Pre-filled syringes, cartridge for Roferon-Pen. 3 mega units-1 x 0.5ml, A22.83; 4.5 mega units-1 x 0.5ml, A34.23; 6 mega units-1 x 0.5ml, A45.65; 9 mega units-1 x 0.5ml, A68.48. S AIDS-related Kaposi’s sarcoma. Chronic active hepatitis B (patients positive for HBV-DNA), chronic hepatitis C (patients positive to HCV antibodies with elevated ALT levels), malignant melanoma, chronic myeloid leukaemia, cutaneous T-cell lymphoma, hairy cell leukaemia. P Hepatitis B: 2.5-5 mega units/m2 by SC inj. 3 times per week for 4-6 months. Increase dose after 1 month if response not adequate, discontinue after 3-4 months if no improvement. Hepatitis C: initially 6 mega units by SC or deep IM inj. 3 times per week for 3 months. Maintenance: 3 mega units 3 times per week for further 3 months. For remaining indications See SPC. Q Not recommended. D Severe renal, hepatic or myeloid dysfunction, epilepsy or CNS impairment, cardiac disease, decompensated hepatic disease, liver cirrhosis. Lactation. B Should only be used by physicians experienced in the indications. Patients with suicidal tendencies. Severe myelosuppression (monitor blood counts). Moderate renal or hepatic impairment (monitor function). Pregnancy (ensure effective contraception). C Immunosuppressants, theophylline. A Influenza-like symptoms, GI and CNS effects, alterations of hepatic function.
SEBIVO
Novartis
2MT Nucleoside analogue. Telbivudine 600mg. White to slightly yellowish, oval film-ctd tab, with LDT on one side. 28, A427.08. S Treatment of chronic hepatitis B in adults with compensated liver disease and evidence of viral replication, persistently elevated serum ALT and histological evidence of active inflammation and/or fibrosis. P 600mg once daily. Renal impairment: Dose adjustment necessary if ccQ50ml/min, see SPC. R Above 65 years, no data. Q Under 16 years, not recommended. D Lactation. B Severe acute exacerbations of chronic hepatitis B may occur; monitor hepatic function
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
217
8.6 ANTIVIRAL
ANTI-INFECTIVES
DRUGS
for at least 6 months after treatment. Monitor for lactic acidosis (usually associated with severe hepatomegaly with steatosis). Myalgia and myopathy may occur (discontinue). Carefully weigh potential benefit and risks of concomitant treatment with products associated with myopathy (e.g. statins, fibrates, ciclosporin). Peripheral neuropathy may occur (particularly with concomitant pegylated interferon alfa-2a); reconsider treatment options if symptoms develop. Cirrhosis: With decompensation, not indicated; without decompensation, caution. Clinical efficacy not established for antiviral resistant HBV. Pregnancy (only if benefits outweigh risk). C Caution: Substances affecting renal function, subcutaneous pegylated interferon alfa2a. Not recommended for use with lamivudine. A Dizziness, headache, cough, diarrhoea, nausea, abdominal pain, rash, fatigue. Increased amylase, lipase, alanine aminotransferase, creatine phosphokinase. See SPC.
raised liver enzymes, lipodystrophy.
2N Protease inhibitor. Fosamprenavir 700mg. Pink film
SYNAGIS
Abbott coated, cap. shaped, biconvex tab., marked GXLL7
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. BMS A Nervousness, fever, inj. site reaction.
on one side. 700mg-60, A455.92. S HIV-1 infected adults in combination with low dose ritonavir and other antiretroviral medicinal drugs. P 700mg twice daily with 100mg ritonavir twice daily, with other antiretroviral agents. R Over 65 years, no data. Q Under 18 years, not recommended.
2N
ALSO TELZIR SUSPENSION Fosamprenavir 50mg as fosamprenavir Ca++ (equivalent to approximately 43mg amprenavir) per ml. Oral suspension. 225ml, A114.47. P 700mg twice daily with 100mg ritonavir twice daily, with other antiretroviral medicinal products. Take without food on empty stomach. Shake bottle for 20 sec before 1st dose and 5 sec before each subsequent dose. R Over 65 years, no data. SUSTIVA Q Under 18 years, not recommended. 2N D Severe hepatic impairment. Pregnancy Roche (unless essential), lactation. Non-NRTI (NNRTI). Efavirenz 50mg, 100mg, 200mg, TAMIFLU B Mild or moderate hepatic impairment, 600mg. Dark yellow/whitecap., white cap., dark 2NO sulphonamide allergy, chronic hepatitis. yellow cap. and dark yellow tab. resp. All caps. Neuraminidase inhibitor. Oseltamivir (as phos.) C Substrates of CYP3A4 or CYP2D6 (e.g. marked with SUSTIVA and strength. 600mg, cap.30mg, 45mg, 75mg. Hard caps. Resp. light yellow flecainide and propafenone), rifampicin, St Johnâ&#x20AC;&#x2122;s shaped, film-ctd tab. marked with SUSTIVA on opaque body/light yellow opaque cap; grey both sides. 50mg-30, A29.47; 100mg-30, A58.94; opaque body/grey opaque cap; grey opaque body/ wort, halofantrine, oral contraceptives. Caution: Lopinavir, rifabutin, anticonvulsants, 200mg-90, A352.96; 600mg-30, A335.19. light yellow opaque cap. All marked ROCHE on S In combination with other antiretroviral body and strength on cap. 30mg, 45mg, prices on immunosuppresants, TCAs, oral anticoagulants. A Headache, dizziness, GI disorders, rash agents for the treatment of HIV-1 infected request. 75mg-10, A20.88. and fatigue. patients. 2NO P In combination with NRTI with or ALSO TAMIFLU SUSPENSION Oseltamivir (phos.) TRIZIVIR GSK without a PI, 600mg once daily on empty stomach. 12mg/ml. Powder for oral suspension. 10 doses of Q Under 3 years or under 13 kg, not 2JN 75mg, A20.88. recommended; 13-15kg, 200mg once daily; 15S Treatment of influenza virus in presence NRTIs. Abacavir sulph. 300mg, lamivudine 150mg, 20kg, 250mg once daily; 20-25kg, 300mg once of symptoms typical of influenza, when influenza zidovudine 300mg. Blue-green cap-shaped film-ctd daily; 25-32.5kg, 350mg once daily; 32.5-40kg, tab. marked GX LL1 one side. 60, A803.57. virus is circulating in the community. Post 400mg once daily; over 40kg or over 17 years, as S HIV infection in adults. Not for use in exposure prevention. Not a substitute for per adults. patients carrying the HLA-B*5701 allele, unless no influenza vaccination. 2N other therapeutic option available. P Treatment: Initiate within 2 days of first ALSO SUSTIVA ORAL SOLUTION Efavirenz 30mg/ P 1 twice daily. onset of symptoms. 75mg twice daily for 5 days. A ml. 180ml, 98.15. Post exposure prevention: Initiate within 2 days of Q Under 18 years, not recommended. P 24ml once daily, in patients unable to D End-stage renal disease, hepatic exposure. 75mg once daily for 10 days. Severe swallow tabs or caps. renal impairment, see SPC. Susp: An oral dispenser impairment. Neutrophil counts (Q0.75 x 109/L) or V 3-17 years, see SPC. Hb level (Q7.5g/dl or 4.65 mmol). Pregnancy, with 30mg, 45mg and 60mg graduations is D Severe hepatic impairment. Pregnancy lactation. provided for dosing. (adequate contraception for 12 weeks after Q Treatment: Initiate within 2 days of first B Hypersensitivity reactions. Discontinue if discontinuation), lactation. onset of symptoms. Duration: 5 days. 13-17 years: symptomatic hyperlactatemia, metabolic/lactic B Mild to moderate hepatic impairment, acidosis, or elevating aminotranferase level occur. 75mg twice daily. 1-12 years: R15kg, 30mg twice hepatitis B or C; monitor liver enzymes, consider daily; q15kg-23kg, 45mg twice daily; q23kg-40kg, Co-infection with hepatitis B. withdrawal if transaminase 5 x normal. Severe 60mg twice daily; q40kg, 75mg twice daily. Under C Drugs mainly eliminated via cationic renal failure; monitor patient closely. History of 1 year (in case of H1N1 pandemic): 2-3mg/kg twice transport eg trimethoprim. Ganciclovir, foscarnet, seizures. Inflammatory reaction (immune phenytoin, aspirin, codeine, morphine, daily under medical supervision. Post exposure reactivation syndrome) may arise. Cases of indomethacin, ketoprofen, naproxen, oxazepam, prevention: Initiate within 2 days of exposure. osteonecrosis have been reported. Driving/ Duration: 10 days. 13-17 years: 75mg once daily. 1- lorazepam, cimetidine, clofibrate, dapsone, operating machines. isoprinosine. Systemic pentamidine, 12 years: R15kg, 30mg once daily; q15kg-23kg, C Terfenadine, astemizole, cisapride, pyrimethamine, co-trimoxazole, amphoteracin, 45mg once daily; q23kg-40kg, 60mg once daily; midazolam, triazolam, pimozide, bepridil, ergot flucytosine, interferon, vincristine, vinblastin, q40kg, 75mg once daily. Under 1 year (in case of alkaloids, voriconazole, St Johnâ&#x20AC;&#x2122;s wort (all dozorubicin. Tribavirin, probenecid. contraindicated), saquinavir, itraconazole. Caution: H1N1 pandemic): 2-3mg/kg once daily under A Nausea, vomiting, diarrhoea, abdominal medical supervision. Other substrates of CYP3A4, indinavir, lopinavir/ pain, Headache, elevated liver function tests, ritonavir, ritonavir, grapefruit juice, rifabutin, oral B Safety and efficacy not established: Severe or unstable medical condition at imminent myalgia, dyspnoea, cough, rash, fever lethargy, contraceptives (also use reliable barrier malaise. risk of requiring hospitalisation, contraceptive), anticonvulsants, methadone, statins. Not recommended with fixed combination immunocompromised, chronic cardiac disease and/ TRUVADA Gilead or respiratory disease. Severe renal impairment. tab. Pregnancy, lactation. 2JN containing efavirenz, emtricitabine, tenofovir C Chlorpropamide, methotrexate, NRTIs. Emtricitabine 200mg and tenofovir disoproxil fumarate (Atripla). phenylbutazone. disoproxil 245mg (equiv. tenofovir disoproxil A Skin rash; discontinue if severe. CNS A Vomiting, nausea, headache. fumarate 300mg or tenofovir 136mg). Blue, cap.reactions (dizziness, insomnia, impaired shaped, film-ctd tab. marked GILEAD on one side concentration, abnormal dreams, somnolence), TELZIR GSK and 701 on reverse. 30, A691.74. anxiety, depression, GI upset, headache, fatigue,
218
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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 VALCYTE Roche lactose. C Caution at high valaciclovir doses (8g/ 2JNT day): Ciclosporin, tacrolimus, mycophenolate Nucleoside analogue. Valganciclovir (HCl) 450mg. mofetil. Pink oval film-ctd tab. marked VGC one side, 450 A Nausea, headache. on reverse. 60, A1953.95. S Induction and maintenance treatment VALOTIX Rowex of cytomegalovirus (CMV) retinitis in patients with 2NO AIDs. Antiviral. Herpes-specific enzyme inhibitor. P 2 twice daily for 21 days with food. Valaciclovir (HCl) 500mg. White to off-white cap.Maintenance 2 once daily. shaped film-ctd tab. with 500 debossed on one R Not recommended. side. 10, A19.14. Q Not recommended. S In immunocompetent patients: D Hypersensitivity to aciclovir and Treatment of Herpes zoster in patients q50 years; valaciclovir. Lactation. B Women of child bearing potential must treatment of initial and recurrent genital Herpes simplex infections. Prophylaxis of cytomegalovirus use contraception. Men must use barrier (CMV) infection and disease, in particular after contraception during treatment and for 90 days renal transplantation, except after lung after. Do not initiate therapy if absolute transplantation. neutrophil count Q 500 cells/microL, platelet P Prevention of zoster-associated pain: 1g count Q 25000/microL, Hb Q 8g/dL, pre-existing or drug relayed haematological cytopenia, patient three times daily for 7 days. Initiate asap after start of infection, within 72 hrs of appearance of receiving radiotherapy. Monitor patients with skin lesions. Genital herpes simplex: 500mg twice renal impairment. Life-threatening adverse daily for 10 days for initial episode; 1g per day in reactions. 1 or 2 divided doses for 5 days for recurrent C Imipenem-cilastatin, didanosine, episodes. Initiate asap, preferably at prodromal myelosuppressive drugs e.g. zidovudine, drugs stage or when lesions appear. CMV infections affecting renal function. prophylaxis : 2g four times daily. Initiate asap A GI upset, anorexia, mouth ulceration, after transplant. Adapt dose according to cc (see neutropenia, anaemia, thrombocytopenia, SPC). Treatment duration: 90 days (longer leukopenia, pancytopenia, abnormal hepatic treatment may be necessary in high risk patients). function, diarrhoea, dermatitis, depression, Renal impairment: See SPC. anxiety, headache, fatigue. Q Prophylaxis of CMV infections: Over 12 years: As per adults. Under 12 years, not VALHERP Ergha recommended. 2NO B Caution: History of renal impairment, Antiviral. Herpes-specific enzyme inhibitor. elderly, hepatic impairment, liver transplantation. Valaciclovir (HCl) 500mg. Creamy, oblong film-ctd Maintain adequate hydration. Use in genital A A A tab. 10, 18.50; 30, 55.49; 42, 77.66. herpes: Safer sex practices also recommended. Pregnancy, lactation (consider topical treatment). S Treatment of herpes zoster (shingles). Treatment and prevention (suppression) of herpes C Caution if impaired renal function simplex infections of skin and mucous membranes, (regular monitoring recommended): Immunosuppressants, aminoglycosides, incl. initial and recurrent genital herpes.
S In antiretroviral combination therapy for the treatment of HIV-1 infected adults. P 1 once daily with food. Renal impairment (cc 30-49ml/min): 1 every 48 hrs. Q Under 18 years, not recommended. D Pregnancy (unless no alternative), lactation. B Renal impairment; not recommended if severe or in haemodialysis. Monitor for signs of toxicity. Monitor renal function before therapy, every 4 weeks during 1st year, then 3 monthly. Prexisting liver dysfunction, monitor. HBV/HCV coinfection, monitor several months after stopping drug. Antiretroviral-experienced patients with HIV1 with K65R mutation; avoid. Lactic acidosis, lipodystrophy, decreased BMD, osteonecrosis. Child exposed in utero; possible mitochondrial dysfunction. Immune Reactivation Syndrome. Contains lactose. C Avoid co-admin. with nephrotoxic drugs, emtricitabine, tenofovir disoproxil (as fumarate) or other cytidine analogues, eg. lamivudine and zalcitabine. Caution: Triple nucleoside therapy, didanosine, atazanavir, drugs eliminated by active tubular secretion. A Neutropenia, allergic reaction, hypophosphataemia, insomnia, headache, dizziness, GI disorders, elevated serum lipase and amylase, hypertriglyceridaemia, hyperglycaemia, increased liver enzymes, skin disorders, elevated CK, pain.
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
GSK
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. Impaired renal function, see SPC. Q Not recommended. B Caution: Severe renal impairment, elderly, liver disease. Maintain adequate hydration. Use in genital herpes: Safer sex practices also recommended. Pregnancy, lactation. A Mild headache. Nausea.
VIDEX
BMS
2N Nucleoside analogue. Didanosine 125mg, 200mg, 250mg, 400mg. White caps. marked 6671, 6672, 6673 or 6674 one half and BMS and strength on other. 125mg-30, A82.94; 200mg-30, A130.12; 250mg-30, A165.89; 400mg-30, A265.43. S Combination therapy for antiviral treatment of HIV infection. P Under 60kg, 250mg daily; over 60kg, 400mg daily, as single dose or two doses 12 hrs apart. Take at least 2 hrs before/after meals. Q Over 6 years, initially 240mg/m2 daily (or 180mg/m2 daily in combination with zidovudine). D Children Q 6 years. B Pregnancy, lactation. Renal impairment or neuropathy (adjust dose; see SPC), hepatic impairment. Pancreatitis; monitor serum amylase levels before and during therapy. Monitor triglyceride and liver enzymes. May occur: Lactic acidosis, lipodystrophy, osteonecrosis, immune reactivation syndrome. Monitor for mitochondrial dysfunction. Phenylketonurics, patients on Na+ restricted diets. Retinal or optical nerve lesions may occur, consider yearly ophtalmologic examination. C Tenofovir disoproxil fumarate, lamivudine, tetracyclines, drugs that affect or are affected by gastric pH, ganciclovir. Drugs causing
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
219
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 VIRACEPT Roche marked with logo on the other side. 60, A 252.36. lactose. C Avoid: Nephrotoxic products and drugs 2N S In combination with other antisecreted via hOAT1 (e.g. cidofovir), didanosine. retrovirals for treatment of HIV-1 infected adults, Protease inhibitors. Nelfinavir. tab. 250mg, oral Caution: Some other antiretrovirals (e.g. lopinavir/ powder 50mg/g. 250mg-300, A483.54; 50mg-144g, adolescents, and children. ritonavir, atazanavir). A46.41. P 200mg daily for first 14 days, then A GI disturbances, hypophosphataemia, S HIV infection in combination with other 200mg twice daily. Take in combination with at dizziness, asthenia, pancreatitis, lactic acidosis, least two other antiretroviral agents. Renal antiretroviral drugs. dyspnoea, rash, renal disturbances. dysfunction requiring dialysis: Additional 200mg P 1250mg twice daily or 750mg three following each dialysis treatment recommended; times daily. ZEFFIX GSK ccr20ml/min, no dose adjustment. Q 3-13 years, 25-30mg/kg three times 2NT Q 50kg or above, as for adults. Under daily. See lit. for oral powder. 50kg, see suspension. D Lactation. Nucleoside analogue. Lamivudine 100mg B Impaired renal and hepatic function, butterscotch cap-shaped film-ctd tab marked GX 2N patients with phenylketonuria diabetes, CG5. 28, A97.00. ALSO VIRAMUNE SUSPENSION Nevirapine haemophilia. 2NT (hemihydrate) 50mg per 5ml; susp. 240ml (with C See SPC. oral syringe and adaptor), A78.42. ALSO ZEFFIX ORAL SOLUTION Lamivudine 5mg/ A Diarrhoea, nausea, vomiting, flatulence, P 16 years and older, 20ml once daily for ml; soln. 240ml, A36.59. abdominal pain, rash, elevated creatinine kinase, 1st 14 days, then 20ml twice daily, taken in S Chronic hepatitis B and evidence of viral hepatitis, neutropenia, hypersensitivity reactions. 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. VIRAFERONPEG Schering-Plough Additional 200mg following each dialysis P 100mg once daily. See data sheet for treatment recommended; ccr20ml/min, no dose treatment duration. 2NT adjustment. Q Under 16 years, not recommended. Pegylated interferon alfa-2b. Peginterferon alfa-2b Q Dose by body surface area or body D First trimester of pregnancy, lactation. (rbe) 50mcg, 80mcg, 100mcg, 120mcg, 150mcg. 2 weight. Under 8 years, 4mg/kg or 150mg/m once B Renal impairment, co-infection with Powder and solvent for soln. for inj. in pre-filled 2 delta hepatitis or hepatitis C, cancer daily for 2 weeks, then 7mg/kg or 150mg/m twice pen. ViraferonPeg Pen: 50mcg-1, A107.62; 80mcg2 chemotherapy, transplant patients, HIV patients, daily; 8-16 years, 4mg/kg or 150mg/m once daily 1, A172.21; 100mcg-1, A215.25; 120mcg-1, 2 for 2 weeks, then 4mg/kg or 150mg/m twice daily. advanced liver disease, diabetes. Monitor levels of A264.68; 150mcg-1, A313.68. ALT every 3 months, HBV DNA and HBsAg every 6 Max. 400mg daily. S Monotherapy and combination with months. D Severe hepatic impairment. Preribavirin for adult chronic hepatitis C serum HCVC Trimethoprim, sulphamethoxazole. treatment ASAT or ALATq5ULN. St Johnâ&#x20AC;&#x2122;s Wort, RNA positive patients or anti-HCV. A Malaise, fatigue, RTIs, sore throat, rifampicin. Previous rash, rash with constitution P Once weekly SC inj. Dose depends on headache, abdominal pain, GI disturbance. whether used in combination or as monotherapy. symptoms. Lactation. B Monitor for severe rash or rash with Monotherapy: 0.5-1mcg/kg once weekly for at ZERIT BMS fever, blistering, oral lesions, swelling, least 6 months. Combination therapy: 1.5mcg/kg/ week with ribavirin caps. admin. orally each day in conjunctivitis, facial oedema, muscle or joint pain, 2 N malaise; discontinue. Monitor blood chemistry, Reverse transcriptase inhibitor. 20mg brown cap.; 2 divided doses with food morning and evening incl. liver function, before and during treatment; 30mg light orange/dark orange cap.; 40mg dark for at least 6 months. Mono and combination: discontinue with moderate or severe liver function orange. All marked with company initials, code Continue for additional 6 months in patients abnormalities. Do not initiate if CD4 q250 cells/ and cap. strength. 20mg-56, A226.29; 30mg-56, showing loss of HCV-RNA at 6 months. See SPC. 3 3 in adult females or q400 cells/mm in adult mm A234.63; 40mg-56, A242.82. Q Under 18 years, not recommended. males. Renal or hepatic impairment. Pregnancy. S HIV infection in combination with other D Autoimmune hepatitis, autoimmune Contains lactose (tabs). antiretroviral. disease, severe psychiatric disorders, thyroid C Drugs affecting cyt. P450 eg. efavirenz, P Under 60kg, initially 30mg twice daily; abnormalities, cardiac disease, severe renal or indinavir, lopinavir, methadone, cimetidine (adjust over 60kg, initially 40mg twice daily. Take 1 hr hepatic dysfunction, epilepsy, CNS dysfunction. dose). Rifampicin, ketoconazole (not before meals. Pregnancy, lactation. recommended). Fluconazole, warfarin (monitor Q Under 30kg, 1mg/kg twice daily; over B Monitor patients with CHF, MI, closely). Oral contraceptives (barrier contraception 30kg, adult dosing. taken 1 hr before meals. Take arrhythmias, occular changes. Maintain adequate recommended). 1 hr before meals hydration. Debilitating medical conditions, A Rash, hypersensitivity, GI disorders, 2N coagulation disorders, psoriasis. Combination headache, myalgia, fever, fatigue, hepatitis, ALSO ZERIT POWDER Stavudine 200mg. Powder therapy: Mild/moderate impaired renal function, abnormal liver function, hepatitis, for oral soln. 200ml, A37.13. not recommended (monitor for anaemia). Organ granulocytopenia. P Under 60kg, initially 30mg twice daily; transplant recipients: Alone/combination with over 60kg, initially 40mg twice daily. Take 1 hr ribavirin may be associated with increased rate of VIREAD Gilead before meals. kidney graft rejection. Liver graft rejection also 2N Q Birth-13 days, 0.5mg/kg twice daily; 14 reported. Nucleotide reverse transcriptase inhibitor (NtRTI). days-30kg, 1mg/kg twice daily; over 30kg, adult C Caution: CYP2D6 and CYP2C8/9 Tenofovir disoproxil fumarate 300mg (equiv. dosing. Take 1 hr before meals. substrates, especially those with narrow tenofovir disoproxil 245mg). Light blue, almondD Pregnancy (unless clearly necessary), therapeutic window (eg. warfarin, phenytoin, shaped, film-ctd tab. marked GILEAD 4331 one lactation. Lactose intolerance (caps). flecainide). Methadone (consider risk of QTc side 300 on reverse. 30, A490.60. B Renal impairment (see SPC), elderly, prolongation). Didanosine with ribavirin not S In combination with other antiretroviral history of pancreatitis. Peripheral neuropathy recommended. A Headache, viral infection, fatigue, fever, 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. myalgia, rigors, anorexia, nausea, depression, reactivation syndrome, lipoatrophy, osteonecrosis Q Under 18 years, not recommended. insomnia, alopecia, flu-like symptoms, reported. Powder contains sucrose. D Lactation. inflammation at inj. site. Discontinue if acute
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 dyscrasias, retinal depigmentation.
220
hypersensitivity, prolongation of coagulation markers, or severe CNS effects occur.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
IMMUNOLOGY C Hydroxyurea, zidovudine (avoid), doxorubicine, ribavirin (caution). A Raised ALT/AST, lactic acidosis, hepatitis, lipodystrophy, headache, fatigue, GI/CNS disorders, skin irritations. Lymphadenopathy, neoplasia.
VACCINES
AND IMMUNOGLOBULIN PRODUCTS
times daily at 6 hourly intervals. Over 2 years, same as adult.
2JN
ALSO ZOVIRAX INFUSION Aciclovir 250mg. Powder in vial. 5, A72.82. S Herpes simplex and varicella zoster ZIAGEN GSK infections in normal and immunocompromised patients. 2JN NRTI. Abacavir sulph. 300mg. Yellow film-ctd cap- V 5mg/kg body weight every 8 hours or shaped tab. marked GX623 one side. 60, A341.98. 10mg/kg body weight every 8 hours in immunocompromised patients with varicella 2JN zoster. Both by slow IV inf. ALSO ZIAGEN ORAL SOLUTION Abacavir sulph. B Renal impairment. Maintain adequate 20mg/ml. 240ml, A98.18. hydration. S Antiretroviral combination therapy for C Probenecid. the treatment of HIV infection. Not for use in patients carrying the HLA-B*5701 allele, unless no A Neurological reactions and rashes. Renal impairment with Zovirax IV. other therapeutic option available. P 300mg twice daily or 600mg once daily. 9.1 VACCINES AND IMMUNOGLOBULIN Q Under 3 months, not recommended; 3 months-12 years, 8mg/kg body weight twice daily. PRODUCTS Max. 600mg daily. ACT-HIB Sanofi Pasteur MSD D Severe hepatic impairment. Pregnancy, 2N lactation. B Monitor closely for hypersensitivity Inactivated surface antigen. Capsular reactions (discontinue immediately). Symptomatic polysaccharide of H. influenzae type b conjugated hyperlactatemia, metabolic/lactic acidosis, to tetanus protein 10mcg/0.5ml. Powder in vial hepatomegaly, rapidly elevating hyperlactatemia, plus diluent in amp. 10 x 0.5ml, price available on co-infected with hepatitis C. Hepatic or renal request. impairment. S Active immunisation against invasive C Methadone, phenobarbital, rifampicin, diseases caused by H. influenzae type b such as phenytoin. meningitis and epiglottitis. A Rash, nausea, anorexia, vomiting, P Not applicable. diarrhoea, abdominal pain, dyspnoea, cough, Q Under 2 months, not recommended. 2fever, lethargy, malaise, headache, elevated liver 12 months, three separate inj. each of 0.5ml by function tests, myalgia. deep SC or IM inj. at intervals of 4 weeks usually at the same time as DTP immunisation. 13 monthsZOVIRAX GSK 4 years, 0.5ml as a single dose. D Acute infections. 2NO Herpes-specific enzyme inhibitor. Aciclovir 800mg. A Local erythema. White, biconvex, elongated film-ctd tab. marked AGRIPPAL Chiron Vaccines GX CG1 on one face. 35, A130.36. 2N S Treatment of acute herpes zoster infections. Inactivated surface antigen. Influenza virus A/New P 1 five times daily at 4 hourly intervals Caledonia/20/99 (H1N1)-like strain (A/New for 7 days. Tab. may be swallowed whole or Caledonia/20/99 IVR-116), A/Moscow/10/99 (H3N2)dispersed in water. like strain (A/Panama/2007/99 RESVIR 17), B/Hong Q Not applicable. Kong/330/2001-like strain (B/Shangdong/7/97); 15mcg of each per 0.5ml. Susp. in pre-filled 2NO syringe. 1, A3.00. ALSO ZOVIRAX DOUBLE STRENGTH SUSPENSION S Prophylaxis of influenza, especially in Aciclovir 400mg/5ml. 100ml, A30.82. those over 65 years and those who run an S Treatment of varicella (chickenpox). increased risk of associated complications. P As for Zovirax 800mg above. V 6-35 months, clinical data limited, doses Q Dosage four times daily for 5 days. 0-2 of 0.25ml or 0.5ml have been used; adults and years, 2.5ml. 2-6 years, 5ml. 6-12 years, 10ml. children from 36 months, 0.5ml. For children not Dosage based on 20mg/kg body weight (not to previously vaccinated a second dose should be exceed 800mg) four times daily. given after an interval of 4 weeks. All by IM or 2NO deep SC inj. ALSO ZOVIRAX 200MG Aciclovir 200mg. Blue D Allergy to eggs. Febrile illness, acute shield-shaped tab. marked ZOVIRAX and with infection. triangle. 25, A33.56. B Pregnant high risk patients (weigh risk 2NO ALSO ZOVIRAX SUSPENSION Aciclovir 200mg/5ml. of clinical infection against possible vaccination risk). Response in patients with endogenous/ 125ml, A33.33. S Treatment and long term suppression of iatrogenic immunosuppresion may be insufficient. Not for intravascular use. herpes simplex infections of skin and mucous A Local reactions, fever, headache, membranes. Prophylaxis in immunocompromised malaise, shivering, fatigue, sweating, myalgia, patients. arthralgia (transient, disappearing within 1-2 days P Treatment: 200mg five times daily at 4 of treatment completion). hourly intervals for 5 days. Prophylaxis, (immunocompromised) suppression: 200mg 4 times AVAXIM Sanofi Pasteur MSD daily at 6 hourly intervals. 2N Q Treatment: under 2 years, 2.5ml susp. Inactivated vaccine. Inactivated hepatitis A virus five times daily, for 5 days. Over 2 years, same as 160 antigen units per 0.5ml. Susp. in pre-filled adult. Prophylaxis: under 2 years, 100mg four
9.1
syringe. Price available on request. S Active immunisation against infection caused by hepatitis A virus. P 0.5ml by IM inj. in the deltoid region. A booster should be given 6-12 months later. Q Under 16 years, not recommended. D Severe febrile infections. Pregnancy, lactation. B Hypersensitivity to neomycin. Liver disease. A Mild local pain, asthenia, myalgia, headache, GI disorders, mild fever.
BOOSTRIX
GSK
2N 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. 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 febrile illness. B Review medical history (previous vaccination and occurrence of undesirable events). Caution: To r 40oC, collapse or shock-like state, or crying for r 3 hours (all within 48 hrs of vaccination with pertussis containing vaccine), convulsions within 3 days; bleeding disorder, thrombocytopenia. New onset or progression of severe neurological disorder. Do not admin. intravascularly. Pregnancy (avoid), lactation. A Somnolence, anorexia, pyrexia, inj. site reactions and pain, oedematous swelling of injected limb, irritability, headache, fatigue, GI disorders.
CERVARIX
GSK
2N Viral Vaccine. Human Papillomavirus (HPV) L1 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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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). 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.
following schedule may be used: 0, 7, 21 days followed by a booster at 12 months. Q 0-15 years: 10mcg (0.5ml) IM repeated at 1 month and 6 months. In neonates born to HBsAG positive mothers, hepatitis B immunoglobin may be given simultaneously at different sites within a few hours of birth. Over 16 years same as adults. D Severe febrile infections. B Cardiac or pulmonary insufficiency; debilitated patients; those for whom a systemic reaction might be a serious risk. Adrenaline 1:1000 should be available in case of anaphylaxis. Haemodialysis, immunocompromised. Pregnancy. See SPC. A Mild transient local soreness, erythema and induration at inj. site. Low grade fever, malaise, fatigue, headache, nausea, dizziness. See SPC.
GSK
2
Inactivated split viron. Influenza virus. Complies with WHO recommendation (northern hemisphere) and EU decision for the current season. See SPC. Susp. in pre-filled syringe. Price available on request. S Prophylaxis of influenza. V 0.5ml by IM or deep SC inj. 6-35 months: 0.25-0.5ml and repeat after min. 4 weeks if not previously vaccinated. D Hypersensitivity to egg, to chicken protein, formaldehyde, gentamicin sulphate, Na+ deoxycholate. Febrile illness or acute infection (postpone). B Not to be administered intravascularly. Pregnancy. A Local reactions, fever, malaise, GSK headache.
FENDRIX 2N
Inactivated surface antigen. Hepatitis B surface antigen 20mcg adjuvanted by AS04C and adsorbed on aluminium phosphate. Turbid white suspension for inj. in a pre-filled syringe. 1, price on request. S Active immunisation against hepatitis B ENGERIX B GSK virus infection (HBV) caused by all known subtypes 2N for patients with renal insufficiency (including prehaemodialysis and haemodialysis patients), from Genetically derived surface antigen. Hepatitis B the age of 15 years onwards. surface antigen 20mcg/ml adsorbed onto alum. hydrox. Susp. in single dose prefilled syringe. 1ml- P 0.5ml by IM inj. in the deltoid region, repeated 1 month, 2 months and 6 months later. 1, 0.5ml-1; prices available on request. S Active immunisation against hepatitis B Q Under 15 years, not recommended. D Hypersensitivity after previous virus particularly for those exposed to blood administration of other hepatitis B vaccines. Acute products or in high endemic areas. Booster or to complete course in patients previously immunised severe febrile illness. B Will not prevent infection caused by with other hepatitis B vaccines. hepatitis A, hepatitis C and hepatitis E or other P 1ml by IM inj. into the deltoid muscle, pathogens known to infect the liver. Immune repeated 1 month and 6 months later. Where response to hepatitis B vaccines may be reduced more rapid immunisation is needed, repeat at 1 by old age, male gender, obesity, smoking, admin. month and 2 months, with a booster at 12 months. Booster doses as required after 2 or more route, some chronic underlying diseases. Do not inject intradermally or intravenously. Avoid IM years. Immunocompromised and dialysis patients: admin. into the gluteal muscle. Pregnancy, 40mcg (2ml) in 1ml volumes at different sites, repeated at 1 month and 6 months later. Booster lactation (use only if benefits outweigh risks). doses as required. In exceptional circumstances the A Headache, GI disorder, pain, fatigue, 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
222
fever, redness, injection site swelling.
FLUARIX
GARDASIL
Sanofi Pasteur MSD
2 Viral Vaccine. Human Papillomavirus (HPV) L1 protein type 6, 20mcg; type 11, 40mcg; type 16, 40mcg; type 18, 20mcg. Susp. for inj. in pre-filled syringe. 0.5ml-1, price available on request. S Vaccine for the prevention of highgrade cervical dysplasia (CIN 2/3), cervical carcinoma, high-grade vulvar dysplastic lesions (VIN 2/3), and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18 in 16-26 year old females and 9-15 year old children and adolescents. P 3 separate 0.5 ml doses admin. by IM inj. at 0, 2, and 6 months. If alternate vaccination schedule necessary, admin. 2nd dose r 1 month after 1st dose and 3rd dose r 3 months after 2nd dose. All 3 doses should be given within a 1-year period. Need for booster has not been established. Preferred site: Deltoid area or higher anterolateral area of thigh. Q Under 9 years, not recommended. Over 9 years, as per adults. D Acute severe febrile illness. Must not inj. intravascularly. B Not indicated for treatment of cervical cancer, high-grade cervical, vulvar and vaginal dysplastic lesions or genital warts. Not a substitute for routine cervical screening. Impaired immune responsiveness (no data). Caution: Thrombocytopaenia or any coagulation disorder due to bleeding risk following IM inj. Duration of protection unknown; observed for 4.5 years after completion of 3-dose series. Protective efficacy has not been evaluated in males. Pregnancy (postpone vaccination). A Pyrexia, injection site reactions including erythema, pain, swelling, bleeding, pruritus.
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 Monodose.
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
IMMUNOLOGY
VACCINES
AND IMMUNOGLOBULIN PRODUCTS
9.1
B Live vaccines. C Live vaccines.
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 HBVAXPRO Sanofi Pasteur MSD 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, 2N A Pain, erythema, swelling at inj. site. purified capsular polysaccharide of Hib 10mcg and Recombinant vaccine. Hepatitis B virus surface Malaise, headache, general aches, nausea, itching. conjugated to tetanus toxoid approximately antigen, recombinant (HBsAg) 10mcg/ml. Susp. in 30mcg per 0.5ml. Powder for susp. for inj. in vial. Price available on request. HIBERIX GSK single dose vial and prefilled syringe. Price S Active immunisation of adults and available on request. adolescents 16 years and over against hepatitis B 2N S Active immunisation against diphtheria, virus. Inactivated vaccine. Capsular polysaccharide of P 1ml by IM inj. into the deltoid muscle Haemophilus influenzae type b, covalently bound tetanus, pertussis, poliomyelitis and H. influenzae type b disease from the age of 2 months. Not repeated 1 month and 6 months later. Rapid to tetanus toxoid (PRP-T) 10mcg per 0.5ml. Pellet suitable for children over 36 months. immunisation, 1 ml by IM inj. repeated 1 month, 2 in vial with diluent in amp. Price available on Q 0.5ml by deep IM inj. Primary months and 12 months later. request. Q Under 16 years, not recommended. vaccination schedule: 2 or 3 doses from the age of S Active immunisation against disease 2N 2 months. At least 4 weeks interval between caused by Haemophilus influenzae type b in subsequent doses. Booster vaccination: After ALSO HBVAXPRO 40MCG/ML Hepatitis B virus infants from the age of two months. primary vaccination with 2 doses, booster must be surface antigen, recombinant (HBsAG) 40mcg/ml. P Not applicable. given at least 6 months after last priming dose, Susp. in vial. Price available on request. Q Primary immunisation starts at two S Active immunisation against hepatitis B months of age and consists of three doses with an preferably between 11 and 13 months of age. virus in predialysis and dialysis patients. interval of two months between each dose. 0.5ml After primary vaccination with 3 doses, a booster dose of Hib conjugate vaccine (monovalent or P 1ml by IM inj. into the deltoid muscle by IM inj. combined) must be administered with a timing in repeated 1 month and 6 months later. A booster D Severe febrile illness. dose may be given if antibody level Q10 IU/L. B In subjects with thrombocytopenia and accordance with official recommendations. Q Not recommended. D Known hypersensitivity to neomycin, bleeding disorders, deep SC admin. may be 2N polymyxin and polysorbate 80. Encephalopathy of considered. A Local reactions, mild erythema, pain and unknown aetiology within 7 days following ALSO HBVAXPRO 5MCG/ML Hepatitis B virus mild swelling, fever, loss of appetite, restlessness, previous vaccination with pertussis containing surface antigen, recombinant (HBsAg) 5mcg/0.5ml. vomiting, diarrhoea, unusual crying. vaccine. Acute severe febrile illness. Susp. in vial. Price available on request. B Risk of apnoea in very premature S Active immunisation of children and GSK infants. Caution: Events following previous adolescents up to and incl. 15 years of age against INFANRIX HEXA pertussis vaccine (e.g. temperature r40oC; hepatitis B virus. 2N collapse/shock-like state; persistent, inconsolable P Not recommended. Toxoid/inactivated/genetically-derived surface crying; convulsions). Q 0.5ml by IM inj. into the deltoid muscle antigen/polysaccharide conjugate vaccine. repeated 1 month and 6 months later. 0.5ml by IM Diphtheria toxoid r30IU; tetanus toxoid r40IU; A Pain, swelling, redness at inj. site, fever, inj. repeated 1 month, 2 months and 12 months unusual crying, vomiting, diarrhoea, loss of pertussis toxoid 25mcg, filamentous later. haemagglutinin 25mcg, pertactin 8mcg; hepatitis B appetite, restlessness, nervousness, somnolence. D Severe febrile illness. surface antigen 10mcg; inactivated poliovirus type Solvay B May occur: Apnoea in very premature 1 40D-antigen unit, type 2 8D-antigen unit, type 3 INFLUVAC infants. Pregnancy. 2N 32D-antigen unit; Haemophilus type b A Local reactions, eczema, polyarteritis polysaccharide 10mcg. Powder in vial and susp. for Inactivated surface antigen. Influenza virus A/ nodosa. Wisconsin/67/2005 (H3N2)-like (A/Hiroshima/52/2005 inj. in pre-filled syringe. 10. Price available on IVR-142 reass.) A/New Caledonia/20/99 (H1N1)-like request. HEPATECT Intra Pharma (A/New Caledonia/20/99 IVR-116 reass.) B/Malaysia/ S Primary and booster vaccination of 2N 2506/2004-like strain (B/Malaysia/2506/2004). infants against diphtheria, tetanus, pertussis, IV immunoglobulin. Human hepatitis B Ig. Inj. hepatitis B, poliomyelitis and H. influenzae type b. 15mcg of each per 0.5ml. Pre-filled syringe. 1 A A single unit. Price available on request. Amps-2ml, 123.75; 10ml, 530.36. P Not applicable. S Postexposure prophylaxis following Q Primary vaccination schedule: 3 doses of S Prophylaxis of influenza. V From 36 months, 0.5ml; 6-35 months, parenteral exposure, direct mucous membrane 0.5ml by deep IM injection. Booster doses: In clinical data limited, doses of 0.25-0.5ml have been contact or oral ingestion of hepatitis B positive accordance with official recommendations. Not used. For children not previously vaccinated or material. Prophylaxis in newborns of HBs-antigen intended for children over 36 months. positive mothers, dialysis patients or those D Hypersensitivity to neomycin, polymyxin infected a second dose should be given after at receiving multiple transfusions of blood or previous diphtheria, tetanus, pertussis, hepatitis least 4 weeks. IM or deep SC inj. should be used. D Allergy to eggs, poultry, gentamycin components. B, polio or Hib vaccines. Encephalopathy of and other vaccine contents. Febrile illness. Acute V By IV inj. only. See SPC. unknown aetiology within 7 days of previous
2N
ALSO HAVRIX JUNIOR MONODOSE Hepatitis A virus HM175 strain 720 ELISA units/0.5ml adsorbed 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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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 INTRAGLOBIN F Intra Pharma IM inj. in deltoid region. Do not mix with other vaccines. 2N IV immuoglobulin. Human normal Ig 5%. Soln. in D Acute severe febrile illness, hypersensitivity to diphtheria toxoid. amp. and inf. in bottle. Amp.-20ml, A94.48; Inf. B Pregnancy, lactation. bottles-50ml, A160.62; 100ml, A306.12; 200ml, Thrombocytopenia/coagulation disorders. Will not A600.90. protect against other groups of Neisseria S Replacement therapy for primary and meningitidis or other organisms that cause secondary immunodeficiency states incl. congenital meningitis/septicaemia. agammaglobinaemia and C Acellular pertussis components. Caution: hypogammaglobinaemia. Idiopathic thrombocytopenic purpura in adults or children at 7-valent pneumococcal conjugate vaccine high risk of bleeding or prior to surgery to correct (Prevenar). A Inj. site reactions, fever. Infants: 1st-2nd platelet count. Prophylaxis of recurrent bacterial year, anorexia, irritability, crying, drowsiness, infection in children with symptomatic HIV impaired sleeping, GI disorders. Children: 3.5-6 infection. years, irritability, headache, somnolence. Adults: V Replacement therapy: 100-400mg/kg Headache, somnolence, myalgia. every 2-4 weeks.Thrombocytopenic purpura400mg/kg by IV inf. on five successive days. MENJUGATE Sanofi Pasteur MSD Maintenance, 400mg/kg as required. 2N D Selective IgA deficiencies. B Monitor for signs of anaphylactoid Conjugated vaccine. Meningococcal group C reactions during inf. oligosaccharide 10mcg conjugated to C Live vaccines. Corynebacterium diphtheriae CRM197 protein A Headache, fever, chills, nausea, 12.5-25mcg per 0.5ml. Powder and solvent for vomiting, allergic reactions, rash, arthralgia, back susp. in vials or in kit (vial and syringe). Prices pain. Rarely, hypotension. available on request. S Active immunisation of children (from 2 M-M-RVAXPRO Sanofi Pasteur MSD months), and adults, for prevention of invasive disease caused by Neisseria meningitidis serogroup 2N C. Live attenuated virus. Measles vaccine (Enders attenuated Edmonston strain) 1000 CCID50, mumps V Under 12 months, three doses each of 0.5ml by deep IM inj. in anterolateral thigh, 1st vaccine (Jeryl Lynn strain) 12500 CCID50, rubella dose given not earlier than 2 months and with vaccine (Wistar RA27/3 strain) 1000 CCID50 per dose. Powder and solvent for suspension for inj. in interval of at least 1 month between doses; over 12 months, single 0.5ml dose by deep IM inj. in pre-filled syringe. Price on request. deltoid region. Do not mix with other vaccines. S Active immunisation against measles, Use separate inj. site if more than one vaccine is mumps and rubella. V Over 12 months: One dose inj. IM or SC admin. D Acute severe febrile illness. at elected date. If no response, 2nd dose may be admin. at least 4 weeks after 1st dose. B Pregnancy, lactation, elderly. Thrombocytopenia, coagulation disorder: Admin. C Hepatitis B and pneumococcal SC. Under 12 months, no data. conjugate vaccines (only if medically important). D Pregnancy (within 3 months of A Inj. site reactions, fever. Irritability, vaccination), hypersensitivity to neomycin, drowsiness, impaired sleeping, crying, anorexia, immunodeficiency, febrile illness, untreated TB, diarrhoea, vomiting in younger children, blood dyscrasias, leukaemia, lymphomas of any headache, malaise, myalgia and arthralgia in older type. recipients. B Hypersensitivity to eggs, family history PNEUMOVAX II Sanofi Pasteur MSD of convulsions, history of cerebral injury, thrombocytopenia. Contains sucrose, traces of 2N recombinant human albumin. Pneumococcal vaccine. Purified mix of capsular C Contra: Immunosuppressive therapy. polysaccharides from 23 pneumococcal serotypes Defer blood or plasma transfusions or admin. of 25mcg of each type in 0.5ml. 1 x 0.5ml, price human immune serum globulin for 3 months. Do available on request. not give within 1 month of other live vaccines. S Active immunisation against Tuberculin skin test. pneumococcal disease. A Inj. site reaction, fever, rash. V Over 2 years, 0.5ml by SC or IM inj. D Less than 10 days prior to or during MENINGITEC Wyeth immunosuppressive therapy. Patients with 2N Hodgkinâ&#x20AC;&#x2122;s disease who have received extensive Conjugate vaccine. Meningococcal group C chemotherapy and/or nodal irradiation. Pregnancy, oligosaccharide 10mcg conjugated to lactation. Corynebacterium diphtheriae CRM197 protein B Severely compromised cardiac and approx. 15mcg/0.5ml. Susp. for injection in PFS. 10; pulmonary function. Febrile respiratory illness or price on request. active infection. Revaccination, See SPC.. A Local reactions, fever, relapse of S Active immunisation for prevention of patients who stabilised idiopathic invasive disease caused by Neisseria meningitidis infection. B Anaphylaxis (rare). Immunnosuppressed patients. A Fever, malaise, shivering, fatigue, headache, sweating, myalgia, arthralgia, local reactions.
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thrombocytopenic purpura.
PREVENAR
Wyeth
2N Conjugate vaccine. Pneumococcal saccharide conjugate vaccine containing 2mcg each of saccharide serotypes 4, 9V, 14, 18C, 19F, 23F and 4mcg of saccharide 6B/0.5ml conjugated to CRM197 carrier protein and adsorbed on alum. phos. Susp. for inj. in vial and prefilled syringe. Price available on request. S Active immunisation against disease (incl. sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) caused by the strains of Streptococcus pneumoniae contained in the vaccine. P Not applicable. Q By IM inj. 2-6 months, 3 doses starting at 2 months of age with at least 1 month interval between doses, a 4th dose is recommended in 2nd year of life; Routine infant immunisation programme: 1st dose at 2 months, 2nd dose at least 2 months later, 3rd (booster) dose at 11-15 months ; 7-11 months, 2 doses with at least 1 month interval between doses, a 3rd dose recommended in 2nd year of life; 12-23 months, 2 doses with interval of at least 2 months between doses; 24 months-5 years, one single dose. The need for a booster dose after these immunisation schedules has not been established. D Acute febrile illness. Hypersensitivity to diphtheria toxoid. B Immunocompromised patients may have reduced antibody response. Immune response has been demonstrated in infants with sickle cell disease. Other high-risk groups, data not available. Vaccination in high-risk groups should be considered on an individual basis. Prophylactic antipyretic medication recommended for children receiving simultaneous vaccines containing whole cell pertussis and/or with seizure disorders or history of febrile seizures. Do not admin. intravenously. Protection against all otitis media expected to be low. See SPC. C MnCC vaccines (no data but possible immune interference). A Local reactions, fever.
PRIORIX
GSK
2N Live attenuated virus. Measles virus (Schwarz strain) at least 103.0 CCID503, mumps virus (RIT 4385 strain derived from Jeryl Lynn strain) at least 103.7 CCID503, rubella virus (Wistar RA 27/3 strain) at least 103.0 CCID503. Powder in vial and solvent in pre-filled syringe. 10. Price available on request. S Active immunisation of children 11 months or older, adolescents and adults against measles, mumps and rubella. Use in infants 9-10 months under special circumstances (see SPC). V 0.5 ml by SC inj., can also be given IM. For primary immunisation and/or revaccination according to recommended schedules. D Acute severe febrile illness; hypersensitivity to neomycin; impaired immune responses (primary or secondary); pregnancy. Avoid pregnancy within 3 months after vaccination. B CNS disorder, susceptibility to febrile convulsions or family history of convulsions. Supervision and treatment available in case of a rare anaphylactic event. May contain traces of egg protein: enhanced risk of immediate-type hypersensitivity reactions if history of anaphylactic,
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Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
IMMUNOLOGY
VACCINES
AND IMMUNOGLOBULIN PRODUCTS
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 RABIES VACCINE Sanofi Pasteur MSD immunodeficient close contacts. Contacts of recent vaccinees should observe personal hygiene. A 2N protective immune response may not be elicited in Inactivated virus. Wistar rabies strain PM/WI 38 all vaccinees. Does not protect against gastro1503-3M 2.5 IU/ml. Powder in vial plus WFI. Price enteritis due to other pathogens than rotavirus. available on request. Post-exposure prophylaxis, no data. Risk of apnoea S Prophylaxis and treatment of rabies. in very premature infants. Contains sucrose and Prophylaxis, 3 doses of 1ml by deep SC or IM inj. sorbitol. Must not be injected. on days 0, 7 and 28. Avoid gluteal region; use C None known. deltoid region. Reinforcing doses of 1ml once every 2-3 years. Treatment, if previously primed, 2 A Irritability, loss of appetite, diarrhoea, doses of 1ml at day 0 and between days 3-7 after vomiting, flatulence, abdominal pain, regurgitation of food, fever, fatigue. contact with infected animal. If no previous prophylaxis, 1ml by SC or IM inj. as soon as STAMARIL Sanofi Pasteur MSD possible after contact with infected animal and 5 2N further doses of 1ml given on days 3, 7, 14, 30 and 90. Live stabilised vaccine. Yellow fever vaccine (live). A Local reactions, fever, malaise. Powder for inj. after susp. with NaCl. Price available on request. REVAXIS Sanofi Pasteur MSD S Active immunisation against yellow fever. 2N V Under 9 months, not recommended; Toxoid/inactivated vaccine. Diphtheria toxoid q2 over 9 months, after reconstitution of vaccine, IU, tetanus toxoid q20 IU, inactivated poliomyelitis vaccine per 0.5ml dose. Susp. for inj. single dose should be given by deep SC inj. D Fever, acute disease, malignant in pre-filled syringe. Price available on request. S Active immunisation against diphtheria, conditions. Organ transplant recipients, immunosuppressive treatments, bone marrow tetanus and poliomyelitis in adults and transplant, impaired cell mediated immunity. adolescents, as a booster following primary Pregnancy, lactation. vaccination. A Local reactions, fever, myalgia, rash, P 0.5ml admin. by IM inj. in deltoid urticaria, lymphadenopathy, tiredness, asthenia, region, under certain conditions may be given by headache. SC inj. Booster doses according to local recommendation. TETABULIN Baxter Q Over 6 years, as per adults. 2N D Hypersensitivity to neomycin, streptomycin or polymyxin B. Acute severe febrile Tetanus immunoglobulin. Human tetanus Ig 250 illness. Neurological complications following an IU per 1ml. Liquid in prefilled syringe. 1, A22.41. earlier immunisation against diphtheria and/or S Prophylaxis and and treatment of tetanus. Pregnancy (unless necessary). tetanus. B Not for IV admin. Patients having a V Prophylaxis, single dose of 250 IU IM inj. primary vaccination course or having received a for passive immunisation. A second dose of 250 IU booster containing diphtheria or tetanus toxoid, is recommended 3-4 weeks after first dose in during the 5 years preceding. Thrombocytopenia patients with antibody defeciency or to protect or a bleeding disorder against delayed tetanus.Treatment, usually 3000C Immunosuppressive agents. 6000 IU in combination with other clinical A Pain, erythema, induration, oedema, procedures. fever, malaise, headache, vertigo, nausea/vomiting, B Hypersensitivity reactions. Possibility of pyrexia. transmission of infectious agents. A Local pain and tenderness, fever, ROTARIX GSK cutaneous reactions, nausea, vomiting, hypotension, tachycardia, allergies, anaphylactic2N Viral vaccine. Human rotavirus RIX4414 strain, not type reactions. 6 . less than 10 CCID50 Powder and solvent for oral TETRAVAC Sanofi Pasteur MSD susp. 1, price available on request. S Active immunisation of infants from the 2 N Toxoid/inactivated vaccine. Diphtheria toxoid 30 age of 6 weeks for prevention of gastro-enteritis IU, tetanus toxoid 40 IU, pertussis toxoid 25mcg, due to rotavirus infection. Q Infants (incl. preterm infants born after filamentous haemagglutinin 25mcg, inactivated 27 weeks of gestational age): 2 doses given orally: poliovirus type 1, 2 and 3 80 units/0.5ml. Pre-filled single dose syringe. Price available on request. 1st dose may be admin. from the age of 6 weeks. Leave r4 weeks between doses. Course should S Active immunisation against diphtheria, preferably be given before 16 weeks of age, and tetanus, pertussis and poliomyelitis. completed by 24 weeks of age. It is recommended P Not applicable. that infants who receive a 1st dose of Rotarix Q Primary immunisation can be given as 3 complete the 2-dose regimen with Rotarix. doses at intervals of 1-2 months starting at 2-3 D Hypersensitivity after previous rotavirus months of age, or as 2 doses at an interval of 2 anaphylactoid, or other immediate reactions to eggs; vaccinate with extreme caution. Do not administer intravascularly. C Do not give within 1 month of other live vaccines, or within 3 months of blood transfusion or human gammaglobulins. A Local redness/pain/swelling, fever, URTIs, rash.
9.1
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.
TWINRIX ADULT
GSK
2N Inactivated virus. Not less than 720 ELISA units of inactivated hepatitis A virus and 20mcg of recombinant HBsAg protein per 1ml dose. Susp. for inj. Price available on request. S Immunisation of non-immune adults and adolescents (16 years and over) who are at risk of both hepatitis A and hepatitis B infections. P Primary vaccination consists of three doses: Initially 1ml dose followed by 1ml dose one month later and the third 1ml dose six months after the first (0, 1 and 6 months). In exceptional circumstances the following schedule may be used: 0, 7, 21 days followed by a booster at 12 months. Q Not recommended.
2N ALSO TWINRIX PAEDIATRIC Not less than 360 ELISA units of inactivated hepatitis A virus and 10mcg of recombinant HBsAg protein per 0.5ml dose. Susp. for inj. in prefilled syringe. Price available on request. S Immunisation of non-immune infants, children and adolescents (from 1 year up to and incl. 15 years) who are at risk of both hepatitis A and hepatitis B infections. Q Primary vaccination consists of three doses: Initially 0.5ml dose followed by 0.5ml dose one month later and the third 0.5ml dose six months after the first (0, 1 and 6 months). D Acute severe febrile illness. B Not for post-exposure prophylaxis; not tested in patients with impaired immunity. Does not prevent infection caused by hepatitis C and hepatitis E or other pathogens known to infect the liver. Immune response to hepatitis B vaccines may be reduced by older age, male gender, obesity, smoking, admin. route, some chronic underlying diseases. Avoid intradermal injection or IM admin. into gluteal muscle. Exceptionally, SC admin. to subjects with thrombocytopenia or bleeding disorders. Pregnancy, lactation (only if benefits outweigh risks). C Not to be given at the same time as other vaccines (Paediatric only). A Headache, GI disorders, injection site reactions injection site swelling/pain/redness, fatigue. Paediatric only: Drowsiness, loss of appetite, malaise, fever, irritability.
TYPHERIX
GSK
2N Inactivated surface antigen. Vi polysaccharide antigen of Salmonella typhi (Ty2 strain) 25mcg/ 0.5ml. Sln for inj. in prefilled syringe. 0.5ml-1; price on request. S Active immunisation against typhoid. P 0.5ml by IM inj. at least 2 weeks prior to risk of exposure to typhoid fever. Q Under 2 years, not recommended; over 2 years, as per adult. D Severe febrile illness. B Pregnancy, lactation (only if high infection risk). Caution: Thrombocytopenia or
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
225
9.2 IMMUNOLOGICAL
bleeding disorders. A Local reactions, fever, malaise, general aches, headache, nausea, itching.
TYPHIM VI
IMMUNOLOGY
DRUGS
VIATIM
Sanofi Pasteur MSD
2N Purified and inactivated vaccines. Combined
Sanofi Pasteur MSD 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 VARITECT Intra Pharma (no data). B Hypersensitivity to neomycin. Pregnancy. 2N A Pain, induration/oedema, eryhthema at IV immunoglobulins. Human varicella-zoster Ig. Inj. inj. site, asthenia, headache, GI disorders, myalgia, A A Amps.-5ml, 231.00; 20ml, 938.20. arthralgia, malaise, fever, dizziness. S Prevention of varicella for children 9.2 IMMUNOLOGICAL DRUGS under immunosuppressive treatment, neonates whose mothers contacted chicken pox within 5 ADVAGRAF Astellas days before birth or shortly afterwards. Children suffering from other infectious diseases during 2NT suspected infection with chicken pox. Pregnant Macrolide immunosuppressant. Tacrolimus women after suspected infection with the (monohydrate) 0.5mg, 1mg, 3mg, 5mg. Gelatin pathogens of chicken pox/zoster who lack varicella cap. containing white powder. Marked with antibodies. Treatment of zoster infections in high- strength on resp. light yellow, white, orange, risk patients. Chicken pox prevention: 1ml/kg body greyish red caps and *647, *677, *637, *687 on weight. Zoster infection treatment: 2ml/kg body orange body. 50, prices on request. weight. See SPC. S Prophylaxis of transplant rejection in B Live vaccines. adult kidney or liver allograft recipients. C Live vaccines. Treatment of allograft rejection resistant to treatment with other immunosuppressive VARIVAX Sanofi Pasteur MSD medicinal products. 2N P See SPC. Q Not recommended. Live attenuated virus. Live attenuated varicella B Severe liver impairment. During initial virus (Oka/Merck strain) r1350 PFU per 0.5ml. Powder and solvent for suspension for inj. Price on post-transplant period, monitor BP, ECG, request. neurological and visual status, fasting blood S Vaccination against varicella from 12 glucose levels, electrolytes (particularly K+), liver / months of age. Prevention of infection in renal function, haematology, coagulation values, susceptible individuals who have been exposed to plasma proteins. EBV-associated varicella within 3-5 days. Vaccination up to 5 days lymphoproliferative disorders, ventricular after exposure may modify course of infection. hypertrophy reported (monitor high-risk patients). P r 13 years: Two 0.5 ml doses 4-8 weeks Limit exposure to sunlight / UV light. Discontinue apart, by IM or SC inj. in deltoid region or higher if posterior reversible encephalopathy syndrome anterolateral region of thigh. (PRES) occurs. Increased risk for opportunistic R Over 65 years, no data. infections (incl. BK virus associated nephropathy, Q 1-12 years: Two 0.5ml doses at least 1 JC virus associated progressive multifocal month apart; asymptomatic HIV infection (ageleukoencephalopathy (PML). Medication errors specific CD4+ T-lymphocyte r25%), two 0.5ml (incl. substitution of immediate- or prolongeddoses 12 weeks apart. release tacrolimus formulations) observed; D Blood dyscrasias, leukaemia, lymphomas, alterations in formulation/regimen should only or other malignant neoplasms affecting hemic and occur under supervision of transplant specialist. lymphatic systems. Immunosuppressive therapy, Contains lactose, soya lecithin. Avoid live family history of/existing humoral or cellular attenuated vaccines. Pregnancy (if benefits o immunodeficiency, tuberculosis, fever q38,5 C. outweighs risk). Do not breast-feed. See SPC. Pregnancy, lactation. C Avoid St. Johnâ&#x20AC;&#x2122;s Wort, ciclosporin, B Use contraception for 3 months grapefruit juice, K+ suppls., K+ sparing diuretics. following vaccination. Avoid close association with Caution: CYP3A4 inhibitors/ inducers/ substrates susceptible high-risk individuals for up to 6 weeks (see Appendix I; adjust dose to maintain following vaccination. tacrolimus levels), nephrotoxic/ neurotoxic drugs C Avoid salicylates for 6 weeks after (aminoglycosides, gyrase inhibitors, vancomycin, vaccination. Defer vaccination for 5 months cotrimoxazole, NSAIDs, ganciclovir, aciclovir), oral following blood/plasma transfusions or admin. of contraceptives, plasma protein bound drugs (eg normal human immune globulin or varicella zoster oral anticoagulants, oral antidiabetics). immune globulin (VZIG). A Headache, tremor, GI disorders, renal A Fever, upper respiratory infection, impairment, diabetes, hyperglycaemia, irritability, pruritus, rash, inj. site reactions. hyperkalaemia, hypertension, abnormal liver
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. P 0.5ml by deep SC or IM inj. Q Under 18 months, suboptimal response; asses risk of exposure. Over 18 months, same as adult. D Acute infections. B Pregnancy, lactation. A Local reactions, fever, malaise, headache.
226
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 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
Gerard
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.
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
IMMUNOLOGICAL
DRUGS
9.2
propafenone, prednisolone, methylprednisolone, 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 MYFORTIC Novartis cramp, myopathy. Rarely hyperkalaemia, hyperuricaemia, hypomagnesaemia, 2MT hypercholesterolaemia, oedema, convulsions, Immunosuppressant. Mycophenolic acid (as headache, rash, mild anaemia, haemolytic uraemic IMURAN Aspen mycophenolate Na+) 180mg, 360mg. Lime green, round tab. marked C and pale orange ovaloid tab. syndrome, weight gain, pancreatitis, colitis, 2NO paraesthesia, neuropathy, confusion, Cytotoxic immunosuppressant. Azathioprine 25mg, marked CT resp. Both film-ctd. 180mg-120, 360mg- dysmenorrhoea, amenorrhoea, gynaecomastia, 120; price available on request. 50mg. Round, biconvex, film-ctd tabs. 25mg: encephalopathy. S In combination with cyclosporin and Orange marked GXEL5. 50mg: Yellow marked corticosteroids for the prophylaxis of acute GXCH1. 25mg-100, A29.52; 50mg-100, A44.91. PROGRAF Astellas transplant rejection in adult patients receiving 2JNO 2NT allogeneic renal transplants. + ALSO IMURAN INJECTION Azathioprine (Na salt) P 720mg twice daily with or without food Macrolide lactone immunosuppressant. Tacrolimus 50mg. Powder in vial. 1, A19.08. (adhere to selected option). De-novo patients, 0.5mg, 1mg, 5mg. Light yellow, white, grey-red S Transplantations; certain auto-immune initiate treatment within 72 hours following cap. marked with strength and 607, 617 and diseases. transplantation. Tab. should not be crushed. 657 resp. 50, prices on request. V Transplant: Loading dose up to 5mg/kg Q Children and adolescents, not 2NT daily; maintenance 1-4mg/kg daily. Other recommended. ALSO PROGRAF CONCENTRATE FOR INFUSION D Pregnancy, lactation. Tacrolimus 5mg/ml. Conc. soln. in amp. 10, price PRESCRIBING NOTES B Increased risk of lymphomas and other on request. IMMUNOSUPPRESSANTS malignancies; limit exposure to sun and UV. S Immunosuppression in liver, kidney and Monitor for neutropenia; complete blood counts Immunosuppressants are used to suppress the heart allograft recipients. Treatment of allograft weekly during 1st month, twice monthly for 2nd rejection resistant to other immunosuppressive rejection of transplanted organs, but are also and 3rd months, then monthly through 1st year. regimens. useful in the treatment of a range of other Severe renal impairment, serious digestive system V See SPC. inflammatory and auto-immune states. disease. Rare hereditary deficiency of D Hypersensitivity to polyoxyethylene Azathioprine is widely used in transplantation, hypoxanthine-guanine phosphoribosyl-transferase hydrogenated castor oil (IV only). and for a range of auto-immune conditions. It is (HGPRT); avoid. Contains lactose. B Severe liver impairment. During initial cytotoxic, and inhibits DNA synthesis, preventing C Live attenuated vaccines, azathioprine post-transplant period, monitor BP, ECG, the multiplication of lymphocytes that are (not recommended). Caution: Aciclovir or neurological and visual status, fasting blood ganciclovir, Mg-Al containing antacids, drugs that glucose levels, electrolytes (particularly K+), liver induced by the introduction of a new allergen bind bile acids (eg. colestyramine, oral activated and renal function, haematology, coagulation into the body, as occurs in transplantation. Its charcoal). values, plasma proteins. EBV-associated actions are non-specific. Side effects include A Opportunistic infections, leukopenia, lymphoproliferative disorders, ventricular myelosuppression, mainly leucopenia and anaemia, thrombocytopenia, headache, cough, GI hypertrophy reported (monitor high-risk patients). thrombocytopenia. disorders, fatigue, pyrexia, abnormal hepatic Limit exposure to sunlight and UV light. Contains Mycophenolic acid (as mycophenolate mofetil function tests, increased blood creatinine. lactose. Pregnancy (if benefits outweighs risk). Do or mycophenolate sodium) is more specific in its not breast-feed. action. It is used prophylactically as a treatment NEORAL Novartis C Avoid grapefruit juice, St John’s wort, for acute allogeneic renal transplant rejection, live vaccines, K+ suppls., K+ sparing diuretics, 2MT ciclosporin. Caution: CYP3A4 substrates/ inhibitors/ usually in combination with cyclosporin and Fungal metabolite immunosuppressant. inducers (eg macrolide antibiotics, see Appendix I), corticosteroids. Cyclosporin 25mg blue-grey oval cap., 50mg nephrotoxic/neurotoxic drugs (aminoglycosides, Cyclosporin is also more specific in action than yellow-white oblong cap.; 100mg blue-grey gyrase inhibitors, vancomycin, cotrimoxazole, oblong cap. All marked with S in a triangle and azathioprine, It inhibits lymphocyte replication cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; NSAIDs, ganciclovir, aciclovir), oral contraceptives, and the production of interleukin 2. It has fewer plasma protein bound drugs (eg oral 100mg-30, A96.03. side effects on bone marrow but is significantly anticoagulants, oral antidiabetics). 2MT nephrotoxic, so kidney function should be A GI disorders, renal impairment, ALSO NEORAL ORAL SOLUTION Cyclosporin monitored. The absorption of cyclosporin is hyperglycaemia, diabetes mellitus, hyperkalaemia, 100mg/ml. Oral soln. 50ml, A143.89. insomnia, tremor, headache, seizures, disturbances dependant on the presence of bile in the gut and S Immunosuppression in organ and bone in consciousness, paraesthesias and dysaesthesias, as the brands vary in their bioavailability, the marrow transplantation; prophylaxis and peripheral neuropathies, dizziness, ischaemic brand must be specified when prescribing. treatment of graft-versus-host disease. coronary artery disorders, tachycardia, tinnitus, Tacromilus is a macrolide lactone V See lit. vision blurred, rash, arthralgia, muscle cramps, immunosuppressant, used as a first line B Only use under specialist supervision. pain in limb/ back. See SPC. Closely monitor renal and liver function, BP and treatment or in those patients resistant to other serum lipids, serum K+. Hyperkalaemia, immunosuppressive regimens. It has a similar RAPAMUNE Wyeth hyperuricaemia. Pregnancy, lactation. Not mode of action to cyclosporin and similar side bioequivalent to Sandimmun; specify brand when 2 N T effects. It also has cardiac effects and can cause Immunosuppressant. Sirolimus 1mg, 2mg. White prescribing. cardiomyopathy, it is recommended that those and yellow triangular ctd tabs. marked C Systemic antibiotics, live vaccines, patients receiving the drug should be monitored RAPAMUNE and strength. 30. Price available on phenytoin, ketoconazole, fluconazole, carefully by echocardiography. request. itraconazole, erythromycin, rifampicin, 2NT References available on request. carbamazepine, barbiturates, Ca++ antagonists, HMG-CoA reductase inhibitors, colchicine, ALSO RAPAMUNE ORAL SOLUTION Sirolimus Revised November 04 nephrotoxic drugs, oral contraceptives, 1mg/ml. 60ml. Price available on request.
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.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
227
10.1 TONICS
DIETETICS
AND BITTERS
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. Q Under 18 years, not recommended. D Pregnancy, lactation. Use effective contraception during therapy and for 12 weeks after use. B Hepatic impairment. Increased susceptibility to infections; development of lymphoma and other malignancies, particularly of the skin, exposure to sun and UV light; new onset nephrosis. Antimicrobial prophylaxis for Pneumocystis carinii pneumonia, admin. for 12 months; cytomegalovirus (CMV) prophylaxis, admin. for 3 months. Monitor for hyperlipidemia, initate therapy if necessary. Monitor urinary protein excretion periodically. Reports of fluid accumulation and hypersensitivity reactions. Severe hepatic impairment: After a loading dose or a change of dose, perform therapeutic drug monitoring for a prolonged period of time until stable concentrations are reached. Contain sucrose and lactose. C Not recommended: Strong inhibitors of CYP3A4 (e.g. ketoconazole, voriconazole) or inducers of CYP3A4 (e.g. rifampicin, rifabutin), ciclosporin, mycophenolate mofetil and corticosteroids combined with Il-2 receptor antibody induction. Caution: Other inducers/ inhibitors of CYP3A4, cisapride, metoclopramide, oral contraceptives, calcineurin inhibitors. A UTI, sepsis, pneumonia, pyelonephritis, herpes simplex, fungal, viral, and bacterial infections, skin cancer, thrombocytopenia, anaemia, thrombotic thrombocytopenic purpura/ haemolytic uraemic syndrome, leukopenia, neutropenia, abnormal liver function tests, hypokalaemia, hypophosphataemia, hypercholesterolaemia, hyperglycaemia, hypertriglyceridaemia, tachycardia, lymphocele, DVT, pneumonitis, epistaxis, abdominal pain, diarrhoea, stomatitis, acne, rash, arthralgia, osteonecrosis, proteinuria, peripheral oedema, impaired healing, oedema, pyrexia, blood lactate dehydrogenase increased, AST/ALT increased.
50mg/ml; amps. 10 x 1ml, A25.36. S Immunosuppression in organ and bone marrow transplantation; prophylaxis and treatment of graft-versus-host disease. V See lit. D Hypersensitivity to cyclosporin or to polyethoxylated castor oils (IV only). B Monitor renal and liver function, BP and serum lipids. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. C Systemic antibiotics, live vaccines, phenytoin, ketoconazole, fluconazole, 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 Anaphylactoid reactions may occur with infusion. 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.
request. S Immunosuppression in solid organ transplantation, in conjunction with other immunosuppressive drugs: Prevention of graft rejection in renal or heart transplantation; treatment of steroid resistant graft rejection in renal transplantation. P Graft rejection prophylaxis: 1-1.5mg/kg/ day for 3-9 days after kidney transplantation. 12.5mg/kg/day for 3-5 days after heart transplantation. Steroid resistant graft rejection: 1.5mg/kg/day for 7-14 days after kidney transplantation. Obese patients, base dosing on ideal weight rather than actual weight. See SPC. Q As per adults; no data for graft rejection in renal transplantation. D Hypersensitivity to rabbit proteins. Active acute or chronic infections. Lactation. B Serious immune-mediated reactions (anaphylaxis, severe cytokine release syndrome) may occur rarely. May occur: Infections, reactivation of infection, sepsis, injection site reactions. Monitor blood cell and platelet count during and after treatment. May increase incidence of malignancies, lymphoma or posttransplant lymphoproliferative disease. Immunisation with live attenuated vaccines not recommended. Pregnancy (only use if clearly needed). Driving/operating machines. C May interfere with ELISA tests. A Lymphopenia, neutropenia, thrombocytopenia, GI disorders, fever, shivering, serum sickness, infection, myalgia, malignancy, Novartis dyspnoea, prutitus, rash, hypotension.
SIMULECT 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 SANDIMMUN Novartis wound complication, weight increase, increased 2MT serum creatinine, hypophosphataemia, diarrhoea and upper RTI (in adults), UTIs, hypertrichosis, Fungal metabolite immunosuppressant. rhinitis, fever, hypertension, upper respiratory Cyclosporin 25mg pale pink oval cap., 50mg 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 ALSO SANDIMMUN ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A129.09.
2NT ALSO SANDIMMUN IV INFUSION Cyclosporin
228
10.1 TONICS AND BITTERS
EFFICO
Ocean
2 Tonic. Thiamine (HCl) 0.18mg, nicotinamide 2.1mg, caffeine 20.2mg per 5ml. Syrup. 300ml, A3.29. S As an adjunct during convalescence, 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 THYMOGLOBULINE Genzyme weight). Admin. IV drip inf. or slow IV inj. or as 2N undiluted soln. IM. Immunoglobulin. Rabbit anti-human thymocyte Q Under 14 years, not recommended. D Non-iron deficiency anaemia, iron immunoglobulin 25mg (5mg/ml in reconstituted overload/utilisation disturbances. Iron mono/ sln). Powder for sln for inf. in vial. 1. Price on
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 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 ironcarbohydrate complexes A Dyspnoea, GI disturbances, flushing, pruritus, rash, blurred vision, feeling hot, cramps, numbness, local inj. site reactions. Hypotension (IV given too rapidly).
ELECTROLYTES, FLUIDS
AND PARENTERAL NUTRITION
C Tetracyclines, antacids. A Mild GI upset.
FER-IN-SOL
10.3
2O ALSO GALFER SYRUP Ferrous fumarate 140mg/ 5ml. 100ml, A3.12.
BMS S Iron-deficiency anaemia.
2O 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.
P 1 cap. or 10ml once or twice daily before meals. Q Infants and young, 2.5-5ml once or twice daily.
2O
ALSO GALFER FA Ferrous fumarate 305mg, folic acid 350mcg. Red/yellow cap. marked GALFER F.A. 28, A1.49. FERROGRAD Teofarma S Prophylaxis of iron and folic acid deficiencies in pregnancy. 2O Haematinic. Ferrous sulf. 325mg (equiv. 105mg Fe). P 1 daily before meals. Q Not applicable. FEFOL SPANSULE Intrapharm Labs. Red sust.-release film-ctd tab. marked with maker’s C Tetracyclines. symbol. 30, A1.66, 150, A7.06. 2 S Iron deficiency anaemia. May be used in A Nausea, constipation. Haematinic. Ferrous sulphate 150mg (equiv. 47mg pregnancy after 13 weeks. 10.3 ELECTROLYTES, FLUIDS AND Fe), folic acid 0.5mg. Green/clear sust.-release cap. P 1 daily before food. PARENTERAL NUTRITION with red, yellow and white pellets. 30, A2.10. Q Not recommended. S Prophylaxis of iron and folic acid 2 ADDIPHOS Fresenius Kabi deficiencies in 2nd and 3rd trimesters of ALSO FERROGRAD C Ferrous sulf. 325mg (equiv. pregnancy. 2N 105mg Fe), ascorbic acid 500mg. Red sust.-release P 1 daily. Phosphate suppl. K+ (phos.) 170.1mg, Na+ (phos.) film-ctd oblong tab. 30, A4.05, 150, A20.25. Q Not applicable. 133.5mg, potassium (hydrox.) 14mg, sorbitol 1mg S Iron deficiency anaemia, especially D Active peptic ulcer, regional enteritis, per ml (providing 2mmol phosphate, 1.5mmol where absorption is a problem. ulcerative colitis, vit. B12 deficiency, paroxysmal P 1 daily before food. nocturnal Hburia, haemosiderosis, PRESCRIBING NOTES Q Not recommended. haemochromatosis, repeated blood transfusion. ANAEMIAS 2O B First trimester. History of peptic ulcer, IRON: Oral iron preparations can be given as ALSO FERROGRAD FOLIC Ferrous sulf. 325mg folate dependent tumours. either the ferrous or ferric salts. The ferrous salts C Tetracyclines, antacids, co-trimaxoazole, (equiv. 105mg Fe), folic acid 350mcg. Two-layer are better absorbed and the type of salt chosen red/yellow sust.-release film-ctd tab. marked with anticonvulsants, penicillamine, chloramphenicol, is not clinically important but usually based on maker’s symbol. 30, A1.71; 150, A7.27. sulphasalazine, cholestyramine. incidence of side effects and costs. Ferrous S Anaemia of pregnancy after 13 weeks. A GI upset, allergic reactions. sulphate (100mg of ferrous sulphate equivalent P 1 daily before food. to 32.5mg of elemental iron) is most commonly FEOSPAN SPANSULE Intrapharm Labs. Q Not applicable. used. Side effects of treatment include a range D Diverticular disease, intestinal 2 of GI disturbances and consequently treatment obstruction, haemochromatosis and iron overload Haematinic. Ferrous sulph. 150mg (equiv. 47mg should be avoided in patients with GI syndromes, sensitivity to some sugars. Vit. B12 Fe). Clear/red sust.-release cap. with green and red deficiency (Ferrograd Folic). obstruction or ulceration. Side effects can be pellets. 30, A1.88. controlled by utilising sustained-release B Delayed intestinal transit. S Iron deficiency anaemias. C Antacids, tetracyclines, captopril. preparations, slowly increasing the dose over P 1-2 daily. Clinistix urine test (Ferrograd C). time and taking the preparations after food. Q Under 1 year, not recommended; 2-12 Changing the salt used can also reduce side years, 1 daily under direction of physician. FERRUM Hausmann effects but may be due to a decrease in the D Undiagnosed anaemia. amount of elemental iron being administered B Haemochromatosis, haemolytic anaemia. 2 with the new preparation. Patients should also Haematinic. Iron hydroxide polymaltose Prolonged or execessive use in children, 1st be warned that iron supplements can also lead (equiv.100mg Fe). Brown/white mottled chewable trimester of pregnancy. to constipation and/or diarrhoea and discolour tab. 30, A4.11. stools. The absorption of iron preparations is S Iron-deficiency anaemia. PRESCRIBING NOTES decreased by concurrent administration of P 1-3 daily. TONICS AND BITTERS antacids and tetracyclines. Q Not recommended. 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.
2 ALSO FERRUM SYRUP Iron hydroxide polymaltose (equiv. 50mg Fe) per 5ml. 150ml, A3.63. P 100-200mg (10-20ml) iron daily. Q 1-12 years, 50-100mg (5-10ml) iron daily; over 12 years, same as adult. D Iron storage or assimilation disease. B Antacids. C Antacids. A GI upset.
GALFER
Thornton & Ross
2O Haematinic. Ferrous fumarate 305mg. Red/green cap. marked GALFER. 28, A1.43. S Prevention and treatment of iron deficiency states. P Prophylaxis: 1 daily. Treatment: 1 twice daily. Q Not recommended
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
229
10.3 ELECTROLYTES,
potassium, 1.5mmol sodium per ml). Soln. in vial. 10 x 20ml, A16.05.
deficiencies in the elderly. Supply of vit. D and Ca++ as adjunct to specific treatments for osteoporosis, in patients with diagnosed or at ADDITRACE Fresenius Kabi high risk of combined vit. D and Ca++ deficiencies. P 1 tab. twice a day with a large glass of 2N water. Pregnant women: 1 tab. a day. Trace elements. Trace elements for addition to Q Not recommended. adult vit. solns. 20 x 10ml, A48.86. D Renal failure. Hypercalciuria and CALCICHEW D3 FORTE Shire hypercalcaemia and diseases / conditions leading to hypercalcaemia and/or hypercalciuria (e.g. 2O myeloma, bone metastases, primary Calcium/vit. D suppl. Ca++ carb. 1.25g (equiv. Ca++ hyperparathyroidism). Kidney stones 500mg), vit. D3 400 IU. White chewable tab. 100, (nephrolitiasis, nephrocalcinosis). Hypervitaminosis A12.31. D. Soya/peanut hypersensitivity. S Vit. D/calcium deficiency in elderly, B Caution: Prolonged treatment, adjunct in osteoporosis, pregnancy, vit. D immobilised patients, sarcoidosis, decreased renal dependent osteomalacia. function. Reduce or interrupt treatment P 2 daily preferably 1 morning and temporarily if urine Ca++ q 7.5mmol/24h (300mg/ evening. 24h). Pregnancy, lactation. Contains sucrose. Q Under 12 years, not recommended. C Caution: Thiazide diuretics, systemic 2O corticosteroids, orlistat, combined ion-exchange ++ ++ ALSO CALCICHEW Ca carb. 1.25g (equiv. Ca resin, paraffin, cardiac glycosides, phenytoin, A 500mg). White chewable tab. 100, 13.49. barbiturates. Absorption may be reduced by S Calcium deficiency states in Caltrate: Tetracycline, iron, zinc, strontium, osteoporosis, osteomalacia, rickets, tetany, estramustin, thyroid hormones, bisphosphonate, malabsorption states, pregnancy and lactation. sodium fluoride, fluoroquinolone. Foods rich in May be used as phosphate binding agent in renal oxalic or phytic acid may inhibit absorption. failure in patients on renal dialysis. CALVIDIN Ergha P 2-6 daily. Q Half adult dose. 2OY D Hypercalcaemia, hypercalciuria. Calcium/vit. D suppl. Ca++ carb. 1500mg (equiv. C Tetracyclines, fluoride, iron, cardiac Ca++ 600mg), cholecalciferol 4mg (equiv. vit. D3 glycosides, thiazide diuretics. 10mcg/400 IU). White chewable scored tab. A Mild GI disturbance, hypercalcaemia. marked C/D. 60, A8.51. S Correction of combined vit. D and CALTRATE Wyeth Healthcare calcium deficiency in elderly, adjunct to specific 2OY treatment for osteoporosis. ++ Calcium/vit. D suppl. Ca (as carbonate) 600mg, P 1-2 daily. cholecalciferol 10mcg (eq. to 400 I.U. vit. D3). Cap.- Q Not recommended. shaped grey/beige tab. scored on 1 side and D Hypercalcaemia, hypercalciuria. engraved with D 600 on each side of score. Other C Tetracycline, fluoride, iron, cardiac side is engraved with Caltrate. 90, A7.84. glycosides, thiazide diuretics. S Correction of combined vit. D and Ca++ A Mild GI disturbances, hypercalcaemia. 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.
230
DIETETICS
FLUIDS AND PARENTERAL NUTRITION
DECAL
Ricesteele
2K Calcium/vit. D suppl. Ca++ lactate 235mg, calcium gluconate 100mg, calcium phosphate 235mg (providing calcium 120mg), vit. D2 50 IU. White tab. scored one side. 50, A1.52. S Calcium and vitamin D supplement. P 1-6 daily. Q 1-3 daily. B History of renal stones.
DIORALYTE
sanofi-aventis
2O Electrolytes. Sodium Cl 0.47g, K+ Cl 0.30g, disodium hydrogen citrate 0.53g, glucose 3.5g. Powder in sachet (plain, flavoured). 20, A4.68. S Oral correction of fluid and electrolyte loss and management of watery diarrhoea. P 20-40ml/kg daily. (Approx. 1-2 sachets after every loose motion). Reconstitute 1 sachet with 200ml fresh drinking water. Q Children: As per adults except 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 stated. Severe renal/hepatic impairment or other conditions where normal electrolyte balance is distributed. If nausea and vomiting present, drink small but frequent amounts at first. If no improvement within 24-36 hr consult physician.
DIPEPTIVEN
Fresenius Kabi
2J Parenteral nutritional. N(2)-L-alanyl-L-glutamine 200mg/ml Concentrate for soln for inf. 50ml, A41.90; 100ml, A71.74. S Intravenous parenteral nutrition regimen as a supplement to amino acid solutions or an amino acid containing inf. regimen, e.g. in patients in hypercatabolic and/or hypermetabolic states. P 1.5 - 2.0ml/kg body weight by central venous inf. Max. daily dose: 2.0ml/kg body weight. Inf. rate R 0.1g amino acids/kg body weight per hour. Duration: Max. 3 weeks. D Severe renal/hepatic insufficiency, severe metabolic acidosis. B Hepatic insufficiency. Pregnancy, lactation. Control serum electrolytes, serum osmolarity, water balance, acid-base status, liver function tests, possible symptoms of hyperammonaemia. Monitor the enzymes alkaline phosphatase, GPT, GOT, bilirubin level and the acid-base status. The choice of a peripheral or central vein depends on the final osmolarity of mixture. Experience q 9 days is limited.
ELECTROLADE
Eastern
2 Electrolytes. Sodium chlor. 236mg, K+ chlor. 300mg, Na+ bicarb. 500mg, glucose 4g. Powder (flavoured) in sachets. 6, A1.39; 20, A4.43. S Replacement of fluid and electrolyte loss. P 1-2 sachets after every loose motion, PRESCRIBING NOTES INFUSIONS
Intravenous infusions are prohibited except for those legitimately received in the course of hospital admissions or clinical investigations.
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
AND PARENTERAL NUTRITION
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 IDEOS Helsinn Birex access to haemofiltration or dialysis. Acute shock hyperglycaemia. Elevated serum levels of any 2Y Calcium/vit. D suppl. Ca++ carbonate 1.25g (equiv. included electrolytes. General contra to infusion therapy. Haemophagocytotic syndrome. Unstable Ca++ 500mg), vit. D3 400 IU. Lemon flavoured conditions. white square chewable tab. 60, A8.61. B Monitor serum triglycerides. Correct S Calcium/vit. D deficiency in elderly, electrolyte and fluid balance disturbances before adjunct in osteoporosis. starting. Caution: Conditions of impaired lipid P 1 twice a day. metabolism (see SPC), metabolic acidosis, Q Not recommended. insufficient cellular oxygen supply, increased D Hypercalcaemia, hypercalciuria, Ca++ serum osmolarity, electrolyte retention. Monitor lithiasis, tissue calcification. Prolonged serum glucose, electrolytes, osmolarity, fluid immobilisation. Vit. D overdose, myeloma and balance, acid-base status and liver enzyme tests. bone metastases, renal insufficiency. Monitor blood cell count and coagulation if fat B Mild to moderate renal failure. Renal insufficiency: C Tetracyclines, vit. D, etidronate, cardiac given for longer period. Control phos. and K+ intake. Addition of trace glycosides, fluoride, thiazide diuretics. elements and vitamins required. Anaphylactic A Hypercalciuria, hypophosphataemia, reaction, interrupt immediately. Initiate slowly. nausea, mild GI disturbance. Obese patients, base dose on estimated ideal INTRALIPID 20% Fresenius Kabi weight. C Insulin, heparin, soybean oil may 2N interact. Parenteral fat emuls. Soya bean oil 100g, egg A Fat overload syndrome (e.g. phospholipids 6g, glycerol 11g per 500ml. hyperlipaemia, fever, fat infiltration, blood Emulsion 2000 kcal/L. Osmolality 350mosmol/kg disorders, coma). Excess amino acid inf (e.g. water. 12 x 100ml, A89.39; 10 x 500ml, A235.71. nausea, vomiting, sweating, rise in body 2N temperature). Hyperglycaemia. ALSO INTRALIPID 10% Soya bean oil 50g, egg phospholipids 6g, glycerol 11g per 500ml. KAY-CEE-L Geistlich Emulsion 1100 kcal/L. Osmolality 350mosmol/kg 2O water. 12 x 100ml, A59.42; 10 x 500ml, A158.01. K+ suppl. K+ chlor. 75mg (equiv. 1mmol K+) per ml. A KABIVEN Fresenius Kabi Mixture. 500ml, 3.04. S Potassium deficiency. 2J P 10-50ml daily in divided doses after Parenteral nutritional. Glucose 19%, amino acids food. and electrolytes (Vamin 18 Novum), fat emulsion Q Contact manufacturer. (Intralipid 20%). Kabiven 8 - 4, A281.88; Kabiven D Renal impairment, dehydration. 11- 4, A298.84; Kabiven 14 -3, A234.42. S Parenteral nutrition for patients when MAGNESIUM VERLA Rowa oral or enteral nutrition is impossible, insufficient 2 or contraindicated. Magnesium suppl. Magnesium aspartate 5g equiv. P 19-38ml/kg body weight/day by IV inf. 121.56mg (5mmol) magnesium. Granules in sachet. into central vein over 12-24 hours. Max. inf. rate Sachets-20, A6.47. 2.6ml/kg/hour. Max. dose 40ml/kg/day. S Correction of magnesium deficiency Q Under 2 years: Contraindicated. 2-10 occuring in association with diuresis, diabetic years: Initially 12.5-25ml/kg and increased by 10acidosis, renal tubular dysfunction, disordered 15ml/kg/day up to max. 40ml/kg/day. Over 10 nutrition. years: As per adults. P One sachet (5g) disolved in water, 1-3 2J times daily. ALSO KABIVEN PERIPHERAL Glucose 11%, amino Q Under 2 years, not recommended; 2-10 acids and electrolytes (Vamin 18 Novum), fat years, one sachet (5g) dissolved in water daily; emulsion (Intralipid 20%). Emulsion for inf. over 10 years, same as adult. Kabiven 5 Peripheral - 4, A262.52; Kabiven 7 D Anuria, oliguria. Peripheral - 4, A273.72; Kabiven 9 Peripheral -3, B Renal dysfunction, diabetes. A220.14. 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.
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, A448.48. P 13-31ml/kg/day by IV inf. over 14-24
10.3
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%
Baxter
2 Amino acids. Essential/non-essential amino acids; electrolyte free. Soln. 100ml, A8.16; 250ml, A11.20. S Formulated for paediatric use.
SANDOCAL 400
Novartis Consumer
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. Q Half adult dose. D Severe hypercalcaemia, hypercalciuria (e.g. hyperparathyroidism, vit. D overdose, decalcifying tumours such as plasmocytoma and skeletal metastases, immobilisation osteoporosis, sarcoidosis), severe renal failure, milk-alkali syndrome, galactosaemia. B Renal impairment, electrolyte imbalance. Monitor for nephrocalcinosis. Avoid vit. D. C Digoxin, cardiac glycosides, tetracyclines. A Mild GI disturbances (constipation, diarrhoea). Symptoms indicating hypercalcaemia (nausea, vomiting, anorexia, constipation, abdominal pain, bone pain, thirst, polyuria, muscle weakness, drowsiness, confusion).
SLOW-K
Novartis
2O
K+suppl. K+ Cl 600mg. Orange round, biconvex, sug-ctd tab. 500, A2.96. S Potassium depletion, especially during diuretic therapy. P Prophylaxis, 2-3 daily. Hypokalaemia, 5-6 daily in divided doses. Max. 12 daily in severe depletion. Q Not recommended. D Advanced renal failure. Untreated Addison’s disease, hypo-reninaemic hypoaldosteronism, acute dehydration, extensive cell destruction, metabolic acidosis, K+ sparing diuretics. B Peptic ulcer. Impaired renal function. Hypomagnasaemia. OSTEOFOS D3 A. Menarini C Lithium, digitalis, antihypertensives, K+ containing diuretics, ACE inhibitors, insulin, oral 2MO hypoglycaemics, NSAIDs. Calcium/vit. D suppl. Ca++ phos. 3100mg (equiv. ++ Ca 1200mg), cholecalciferol 20mcg (equiv. vit. D3 A Ulceration or obstruction of the small bowel (discontinue). Solid dosage forms of K+ salts 800 IU). Sachet, containing powder for oral susp. (may rarely lead to haemorrhage, ulceration or 30 sachets, A9.53. stenosis of the GI). GI upset. S Correction of combined vit. D and calcium deficiency in elderly. As an adjunct to SYNTHAMIN 9 Baxter specific treatment for osteoporosis. 2N R 1 sachet daily. Parenteral nutritional. Amino acids 55g, Q Not recommended. electrolytes providing 9.1g N per litre. Soln. 500ml, D Hypercalcaemia, hypercalciuria, severe
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
231
10.4 VITAMINS A9.40;
AND
DIETARY SUPPLEMENTS
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 ALSO SYNTHAMIN 17 Amino acids 100g, electrolytes providing 16.5g N per litre. Soln. 500ml, A17.89; 1L, A32.49.
VAMIN 9 GLUCOSE
DIETETICS
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.
years: 5ml three times daily. 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.
DECAVIT
NAUDICELLE
Rowa
O
Multivitamin. Vit. A 800mcg, vit. E 10mg, thiamine
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.
Fresenius Kabi (B1) 1.4mg, riboflavin (B2) 1.6mg , vit. B6 2mg, vit.
B12 1mcg, folic acid 200mcg, niacin (B3) 18mg, vit. C 60mg. Orange-red soft gelatin cap. 30, A2.67; 60, A5.08. S Vitamin deficiency, diet supplementation. VAMINOLACT Fresenius Kabi P 1 daily, or as directed. Q Under 6 years, not recommended. 2N B Pregnancy. Parenteral nutritional. Amino acids 65.3g, C Levodopa. electrolytes; providing 9.3g/1 MJ/L. 100ml, A5.17; 500ml, A11.86. HALIBORANGE Seven Seas
2N
Parenteral nutritional. Amino acids 70.2g, glucose 100g, electrolytes; providing 9.4g N, 2.7 MJ/L. 100ml, A4.65; 500ml, A9.66.
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, A1.47 (non-GMS); 98, A3.51. 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 reactions.
CYTAMEN
UCB
2N Vit. B12 suppl. Cyanocobalamin 1000mcg/ml. 1ml amp. 5, A1.95. S Megaloblastic anaemia, other B12 responsive macrocytic anaemias.
232
Bio Oil Research
2
NEO-CYTAMEN
UCB
2N
Vit. B12 suppl. Hydroxocobalamin 1000mcg/ml. 1ml amp. 5, A12.27. S Megaloblastic anaemia, other B12 responsive macrocytic anaemias, tobacco 2 amblyopia, Leberâ&#x20AC;&#x2122;s disease. Vit. C Suppl. Ascorbic acid 1000mg. White, round, V Initially 250-1000mcg IM on alternate flat bevelled-edge effervescent tab. for dissolution, days for 1-2 weeks then 250mcg weekly until blood count is normal. Maintenance, 1000mcg with citrus odour. 20, A3.27. S Prophylaxis and treatment of vitamin C every 2-3months. See lit. for amblyopias. D Megaloblastic anaemia of pregnancy. deficiency. See SPC. V Adult and children q 12 years: 1 tab. C Chloramphenicol, oral contraceptives. dissolved in water daily. D Ascorbic acid q1g daily in patients with A Rare hypersensitivity reactions. hyperoxaluria. OCUVITE LUTEIN Dr. Mann B Large dose may cause diarrhoea. Patients at risk of hyperoxaluria. G6PD deficiency. Vinamins/minerals/carotenoids. Ascorbic acid 30mg, Prolonged use. Caution: Patients with increased vit E 4.4mg, zinc 2.5mg, selenium 10mcg, lutein plasma iron. 3mg, zeaxanthin 0.25mg. Orange film-ctd tab. 60, A9.97. C Fluphenazine. A Nausea, vomiting, abdominal cramping, S To promote healthy nutrition of the eye headache. and to increase macular density and help prevent oxidative damage by free radicals in age related KIDDI PHARMATON Boehringer Ing. SM eye diseases. P 1 twice daily with meals. 2 Q Not applicable. Vit./mineral suppl. Each 7.5ml contains: lysine 150mg, thiamine 1.5mg, riboflavin 1.7mg, ONE-ALPHA LEO Pharma pyridoxine 3mg, nicotinamide 10mg, dexpanthenol 2MO 5mg, cholecalciferol (vit D3) 7.5mcg (300 IU), alpha-tocopherol (acetate) 7.5mg, Ca++ Vit. D suppl. Alfacalcidol 0.25mcg, 1mcg. White, glycerophosphate soln. (equiv. to calcium 65mg, brown cap. 0.25mcg-30, A4.23. 1mcg-30, A12.61. phosphorus 100mg). Orange flavoured syrup. 2MO 100ml, A3.22; 200ml, A4.62. ALSO ONE-ALPHA DROPS Alfacalcidol 2mcg/ml S Supplement for persons requiring a (0.1mcg per drop). 10ml, A30.31. dietary adjunct (convalescence, loss of appetite, S Renal bone disease, correction of specific vitamin deficiencies). hypoparathyroidism, prior to parathyroidectomy P 15ml daily. to minimise post-operative hypocalcaemia. Q 1-5 years: 7.5ml daily; over 5 years: 15ml Nutritional, malabsorptive and vit. D resistant per day. Taken v-1 hours before meals, ideally rickets; osteomalacia. Neonatal hypocalcaemia. breakfast or lunch. May be diluted with water or Osteoporosis. Treatment should be initiated in mixed with food. hospital by specialist. D Hypercalcaemia, hypercalciuria, renal P Initially 1mcg daily adjusting according insufficiency, vit. D containing products, to response. See SPC. hypervitaminosis D. R 0.5mcg daily may be sufficient. B Hypervitaminosis. Pregnancy, lactation. Q Under 20kg, initially 0.05mcg/kg daily; neonates and premature infants 0.05-0.1mcg/kg/ MINADEX TONIC Seven Seas day. V Over 20kg initially 1mcg daily. See lit. 2 D First trimester of pregnancy. Vit./mineral suppl. Vit. A 0.650mg, colecalciferol B Monitor plasma Ca++. 0.065mg, iron 12mg, K+ 2.25mg, Ca++ 11.25mg, C Barbiturates, anticonvulsants. manganese 0.38mg, copper 0.5mg. Oral emulsion A with orange odour and taste. 200ml, 2.63. PABRINEX IV Archimedes S Vitamin and mineral deficiency and as 2N an appetite stimulant during and after illness. P 10ml three times daily. Vit. suppl. Thiamine 250mg, riboflavine 4mg, Q 6 months-3 years: 5ml twice daily. 3-12 pyridoxine 50mg (amp No.1); nicotinamide 160mg,
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
METABOLISM DISORDERS
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.
PHARMATON
depressants or stimulants, levodopa, antihypertensives.
REDOXON
Vit./mineral suppl. Panax ginseng extract 40mg, vit. A 2667 IU, vit. B1 1.4mg, vit. B2 1.6mg, vit. B6 2mg, folic acid 100mcg, vit. B12 1mcg, vit. C 60mg, vit. D3 200 IU, vit. E 10mg, nicotinamide 18mg, iron 10mg, Ca++ 100mg, copper 2mg, magnesium 10mg, zinc 1mg, lecithin 100mg, biotin 150mcg, selenium 50mcg. Cap. 30, A9.24; 100, A24.63. S Fatigue and weakness associated with stress, convalescence, or symptoms of ageing, impaired general health. P 1-2 daily for 8-12 weeks. Q Not recommended. D Pregnancy, lactation. Hypercalcaemia, hypercalciuria, haemochromatosis, iron overload syndrome, hypervitaminosis A or D, renal insufficiency. B Family history of haemochromatosis. Prolonged use. Consult doctor if no improvement within 4 weeks. Peanut or soya allergy. C Retinoid (e.g. against acne) or vitamin D therapy (contraindicated). Caution: CNS
10.5
2K ALSO RUBEX CHEWABLE Ascorbic acid 250mg. Orange flavour tab. 50, A1.76; 150, A4.32.
Bayer HealthCare 2 K
2 Vit. suppl. Ascorbic acid 1g. White effervescent tab. blackcurrent, orange and lemon flavoured. 15, A3.32; 30, A5.32. S Vitamin C deficiency. P Up to 3g daily. Q Under 4 years, not recommeded. 4-12 years, half adult dose. Over 12 years, threequarters adult dose. A Diarrhoea.
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 daily), diabetics. B Risk of hyperoxaluria, G6PD deficiency. C Fluphenazine. A Nausea, vomiting, abdominal cramping, headaches, renal Ca++ calculi.
ROCALTROL
SERAVIT
Roche
2MO Vit. D suppl. Calcitriol 0.25mcg. Caps. One half
Boehringer Ing. SM brown-red to orange-grey opaque, the other
2
AND OBESITY
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. B Withhold other vit. D preps. Pregnancy. Monitor serum Ca++ levels regularly. A Hypercalcaemia, hypercalciuria.
SHS
1O Vit/mineral suppl. Carbohydrate (maltodextrin) 67%, vitamins, trace elements, minerals; Na+ and K+ low. Powder 268kcals/100g. 200g, A19.59. S Therapeutic restricitve diets in infants/ children.
SLOW-K
Novartis
2O
K+suppl. K+ Cl 600mg. Orange round, biconvex, sug-ctd tab. 500, A2.96. S Potassium depletion, especially during diuretic therapy. P Prophylaxis, 2-3 daily. Hypokalaemia, 5-6 daily in divided doses. Max. 12 daily in severe depletion. Q Not recommended. D Advanced renal failure. Untreated RUBEX Ricesteele Addison’s disease, hypo-reninaemic hypoaldosteronism, acute dehydration, extensive 2K cell destruction, metabolic acidosis, K+ sparing Vit. C suppl. Ascorbic acid 50mg, 100mg, 200mg, diuretics. 500mg. Tab. 50mg-100, A1.04; 100mg-100, A1.68; B Peptic ulcer. Impaired renal function. 200mg-100, A2.26; 500mg-100, A4.85. Hypomagnasaemia. S Prophylaxis and treatment of ascorbic C Lithium, digitalis, antihypertensives, K+ acid deficiency. containing diuretics, ACE inhibitors, insulin, oral hypoglycaemics, NSAIDs. PRESCRIBING NOTES A Ulceration or obstruction of the small VITAMINS bowel (discontinue). Solid dosage forms of K+ salts Vitamin A (retinol) (may rarely lead to haemorrhage, ulceration or Deficiency causes ocular defects and increased susceptibility to infections. There is evidence to suggest it stenosis of the GI). GI upset. 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 acid…) 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.
SOLIVITO N
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
XENICAL
Roche
2NO Lipase inhibitor. Orlistat 120mg. Turquoise cap. marked ROCHE XENICAL 120. 84, A55.93. 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
233
10.6 FOODS
DIETETICS
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.
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 Crohnâ&#x20AC;&#x2122;s Disease. For children over 5 years old.
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 UCB suffering from malnutrition). Q Under 1 year, unsuitable.
AMINOGRAN Oral nutritional. Essential, non-essential amino
SHS acids, phenylalanine-free. Powder 1.68 MJ/100g.
ADAMIN-G
500g, A66.71. S Phenylketonuria.
1O
Fresenius Kabi
1O
1O
10.6 FOODS
CALSHAKE
CAPRILON
SHS
1O
Oral nutritional (paediatric). Fat (75% medium chain triglycerides, C8 and C10 fatty acids 28%), ANAMIX SHS protein 12%, carbohydrate 55% (glucose syrup 44%, lactose 11%), vitamins, minerals, trace 1O elements. Whey based infant formula containing PKU ANAMIX INFANT (Formerly known as XP MCT fat. 522kcals/100g. Nutritionally complete. ANALOG LCP). Oral nutritional (paediatric). 420g, A18.73. ADD-INS SHS Carbohydrate 54%, protein equiv. 13%, fat 23% (arachidonic acid, docosahexaenoic acid), vitamins, S Hepato-biliary or pancreatic disease, 1 stagnant loop syndrome. Conditions where minerals, trace elements. Phenylanaline-free digestion, absorption or transport of normal Oral nutritional. Flavourless phenylalanine free powder. 475kcals/100g. 400g, A33.97. dietary fat is disrupted, leading to steatorrhoea. protein substitute containing essential and non S Phenylketonuria in infants 0-1 years essential amino acids, carbohydrates, fat, vitamins, 1 O CAROBEL-INSTANT Cow & Gate calcium, phosphorous, magnesium and trace ALSO HCU ANAMIX INFANT Carbohydrate 54%, 1O elements. 60 x 18.2g, A430.01 protein equiv. 13%, fat 23%, vitamins, minerals, S Dietary treatment of phenylketonuria. trace elements. Methionine free powder. 475kcals/ Thickening agent. Maltodextrin, carob bean gum, V Aged 4 years and above. Ca++ lactate. Powder 251kcal/100g. 135g, A4.18. 100g. 400g, A38.74. S Infantile vomiting and posseting when S Vit.B6 non-responsive homocystinuria no organic cause known. Habitual and recurrent and hypermethioninaemia in infants, aged 0-1 vomiting, e.g. gastrooesophageal reflux. year. Q Suitable for infants and children. 1O D Obstructive lesions (e.g. pyloric stenosis, ALSO MSUD ANAMIX INFANT Essential/non essential amino acids, carbohydrate, fat, vitamins, gastroenteritis), galactosaemic infants (monitor red cell galactose-1-phosphate). minerals and trace elements. Leucine, isoleucine, valine free. Powder. 400g, A38.74. CUBITAN Nutricia S Maple syrup urine disease in infants age 1O D Contraindications: 0-1 years. Oral nutritional. Protein 20g, arginine enriched 3g, Conditions where the product ANTOX Pharma Nord vitamins, minerals, trace elements per 200ml. should not be given. Y Nutritionally balanced sip feed. (3 flavours). 1.25 kcal/ml. Plastic bottle with straw- 200ml, A2.07. Hypersensitivity to a drug Oral nutritional. L-Methionine 480mg, vit. C S Assist the healing of pressure sores. (and/or excipients) or its class 120mg, vit. E 35mg, selenium 50mcg. Yellow oval Q Under 3 years, not recommended. tab. 180, A79.46. is assumed to be a S Chronic pancreatitis. CYSTINE AA SUPPLEMENT Vitaflo P Up to 6 daily. contraindication in all entries. 1O Q Under 16 years, at discretion of Oral nutritional. L-Cystine 500mg on a physician. Under 5 years, not recommended. carbohydrate base. Sachets. 30 x 4g, A58.23. B Special Precautions: D Suspected or proven schizophrenia. S Inborn errors of protein metabolism in Renal insufficiency. Parenteral use. Pregnancy, Conditions where special people from 12 months to 10 years of age. lactation. attention is required, or tests B Use under medical supervision. Not DIALAMINE SHS are to be performed. Serious suitable as sole source of nutrition. Oral nutritional. L-Glutamine. Powder. 20x5g, A21.61. S Conditions requiring increased LGlutamine e.g. catabolic stress, post surgery, multiple trauma, sepsis, chemo/radiotherapy.
WARNINGS
side effects attention.
that
need
1O
Oral nutritional. 30% essential amino acids, carbohydrate, flavourings and low levels of minerals. Orange flavoured powder. 200g, A37.74. Oral nutritional. Arginine 500mg on a S Advanced chronic renal failure and carbohydrate base. Powder. 30, A58.23. certain urea cycle disorders e.g. OTC/CPS deficiency S Dietary management of Inborn Errors of in infants over 6 months, children and adults. Protein Metabolism. Q Infants under 6 months, not suitable.
1O
C Drug Interactions: Drugs which may affect, or be affected by, the product if prescribed together. A
Adverse Drug Reactions: Most frequently reported side effects.
234
ARGININE AA SUPPLEMENT Vitaflo
CALOGEN
Nutricia
1O Oral nutritional. A high energy, long chain triglyceride fat emulsion. 450kcals and 50g fat per 100ml (2 flavours and neutral). 200ml, A5.24; 500ml A12.71. S Renal failure, other conditions requiring a high energy diet, with/without fluid and electrolyte restrictions.
DIASIP
Nutricia
1O Oral nutritional. Protein 4.9g, fat 3.8g, carbohydrate 11.7g, fibre 2g per 100ml; gluten free. 1kcal/ml (3 flavours). Nutritionally complete.
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
Plastic bottle with straw-200ml, A2.50. S Nutritionally complete supplement suitable for patients with hyperglycaemia, impaired glucose tolerance, Type 1 and Type 2 diabetes mellitus. Q Under 3 years, unsuitable.
DIBEN
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 Fresenius Kabi requiring high energy/low fluid diet.
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 feed500ml EasyBag 1kcal/ml, A 5.64. S Diabetes mellitus, impaired glucose tolerance in malnourished patients or those at risk of malnutrition. Q Under 3 years, not suitable.
EAA SUPPLEMENT 1O
P Not applicable.
ENFAMIL O-LAC WITH LIPIL Mead Johnson
1O
Oral nutritional. Protein (milk) 10.9g, carbohydrate (glucose polymers) 55g, fat (vegetable oils, LCPs) 28g, vitamins, minerals, trace elements. Lactose-, sucrose-, fructose- and gluten-free. Powder. Vitaflo 520kcal/100g. Nutritionally complete. 400g, A5.26. S Lactose intolerance.
Oral nutritional. Essential amino acids, carbohydrate, vitamins, minerals and trace elements. Tropical flavoured powder. 50 x 12.5g sachets, A290.94. S Disorders of protein metabolism where essential amino acids are required; urea cycle disorders. Q Suitable for children from 3 years of age.
ENSHAKE
Abbott
1O
Oral nutritional. Energy 434 kcal. Protein 8.1g, fat 15.1g, carbohydrate 66.6g, vitamins and minerals per 96.5g sachet. Powder. Unsuitable as a sole nutritional source. Gluten free. Box of 6 x 96.5g sachets (2 flavours), A16.62. S Increased energy and protein requirements (malnutrition, post operative, DUOBAR SHS EASIPHEN SHS oncology, cystic fibrosis). 1O 1O P Mix 1 sachet with 240ml whole milk. Oral nutritional. Fat, carbohydrate. High energy Oral nutritional. Essential/non-essential amino Q Under 6 years, half sachet mixed with bar, 292 kcal/45g in 3 flavours. 8x42g, A16.16. acids, carbohydrates, fat, vitamins, minerals and 240 ml milk. Under 1 year, not recommended. S Conditions requiring a high calorie, low trace elements. Ready to drink phenylalanine free B Not lactose free. A liquid in 2 flavours. 250ml, 10.13. fluid diet e.g. amino acid metabolism disorders, protein restricted diets, renal and liver diseases in S Phenylketonuria in children over 8 years ENSURE Abbott children and adults. and adults. 1O Q Children under 8 years, not suitable. Oral nutritional. Protein 10.0g, fat 8.4g, DUOCAL SUPER SOLUBLE SHS carbohydrate 33.9g per 250ml. Gluten- and ELEMENTAL 028 EXTRA SHS 1O clinically lactose-free. 1.0kcal/ml. Nutritionally 1 K O Oral nutritional. Carbohydrate 72.7%, fat (35% complete. 250ml can (3 flavours), A3.05. Oral nutritional. Protein (essential, non-essential MCT, 65% LCT) 22.3%, gluten-, protein- and S Disease related malnutrition, pre and amino acids) 12.5g, carbohydrate (sugar, dried lactose-free, electrolyte low. Powder. 492 kcal/ post operatively undernourished patients, glucose syrup) 55g (flavoured), fat (35% MCT, inflammatory bowel disease, total gastrectomy, 100g. Not nutritionally complete. 400g, A18.59. 65% LCT)17.45g, vitamins, minerals, trace elements dysphagia, bowel fistulae, anorexia nervosa, short 1O per 100g. 427kcals/100g (flavoured); 443kcals/100g bowel syndrome, intractable malabsorption. ALSO DUOCAL LIQUID Carbohydrate 23.4%, fat (unflavoured). 100g A7.41. Q Under 5 years, caution. Under 1 year, (30% MCT, 70% LCT) 7.1%, gluten-, protein- and S GI tract impairment (e.g. Crohns disease, not recommended. lactose-free, electrolyte low. Liquid. 158 kcal/ inflammatory bowel disease, short bowel 100ml. Not nutritionally complete. 250ml, A4.13. ENSURE PLUS Abbott syndrome, bowel fistula). 1O ALSO MCT DUOCAL Carbohydrate 74%, fat (83% PRESCRIBING NOTES FOODS Products can be classified into those indicated for disease states, allergic conditions, malnutrition 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.
1O
1O
ALSO ELEMENTAL 028 EXTRA LIQUID Protein (essential, non-essemtial amino acids) 2.5g, carbohydrate (dried glucose syrup, sugar) 11g, fat (coconut, hybrid safflower and rapeseed oil) 3.5g, vitamins, minerals, trace elements per 100ml. 215kcals/250ml (3 flavours) 250ml, A3.83. S GI tract impairment (e.g.Crohns disease, intractable malabsorption, short bowel syndrome, bowel fistula).
Oral/enteral nutritional. Energy 150kcal. Protein 6.25g, fat 4.9g, carbohydrate 20.2g per 100ml; gluten- and clinically lactose-free. 1.5 kcal/ml. Nutritionally complete. Oral: 200 bottle with straw attached (12 milkshake and 3 yoghurt style flavours), A2.26. Enteral: Ready-to-Hang -500ml (flavoured), A6.21; 1L, A12.11; 1.5L, A18.16.
1O
Oral nutritional. Carbohydrate 60%; fat (83% MCT, 17% LCT) 16.4%; protein equiv. 12.5% with vitamins, minerals, trace elements. Powder 438kcal/100g (flavoured and unflavoured). Nutritionally complete. 100g, A7.57. S Severe malabsorption (e.g. cystic fibrosis, HIV infection), where very long chain triglycerides are poorly tolerated. Q Under 1 year, unsuitable.
ALSO ENSURE PLUS SAVOURY Energy 375kcal, protein 15.6g, fat 12.3g, carbohydrate 50.5g. Gluten- and clinically lactose- free. 1.5kcal/ml. Nutritionally complete. 250ml can (2 flavours), A2.26. 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, poor appetite. Q Under 6 years, caution. Under 1 year, not recommended.
ENERGIVIT
ENSURE PLUS CRE`ME
EMSOGEN
SHS
1O
SHS
Abbott
1O
1O
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.
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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
235
10.6 FOODS
DIETETICS
swallowing difficulties, total gastrectomy, pre and postoperative preparation of patients who are malnourished or patients who are looking for an alternative mouth feel. Q Under 6 years, caution. Under 1 year, not recommended.
ENSURE PLUS FIBRE
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
Abbott 1 O
1O (FORMERLY KNOWN AS ENRICH PLUS). Oral nutritional. Energy 305kcal. Protein 12.5g, fat 9.84g, carbohydrate 40.4g, fibre 5.0g (of which FOS 2.5g) per 200ml; gluten- and clinically lactosefree. 1.5kcal/ml. Nutritionally complete. 200ml bottle with straw attached (6 flavours), A2.52. S Disease related malnutrition, pre and postoperative undernourished patients, inflammatory bowel disease, total gastrectomy, post-operative dysphagia, bowel fistulae, anorexia nervosa, short bowel syndrome, intractable malabsorption, immobile patients and the elderly. Q Under 6 years, caution. Under 1 year, not recommended.
1O ALSO ENRICH Energy 256kcal. Protein 9.4g, fat 8.8g, carbohydrate 34.9g, dietary fibre 3.4g per 250ml; gluten- and clinically lactose-free. 1 kcal/ml. Nutritionally complete. 250ml can (1 flavour), A3.56. S Disease related malnutrition, pre- and post-operative undernourished patients, inflammatory bowel disease, total gastrectomy, dysphagia, short bowel syndrome, intractable malabsorption and immobile patients Q Under 5 years, caution. Under 1 year, not recommended.
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.
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.
ENSURE TWOCAL
FORTIMEL
1O
FORTISIP
Nutricia
1O Oral nutritional. Protein 6g, fat 5.8g, carbohydrate 18.4g/100ml. Lactose, gluten free. 1.5kcal/ml (7 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 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. S As for Fortisip. Suitable for patients with diabetes if sipped slowly over a period of 20 mins. or more. Q Children under 6 years, not suitable. D Galactosaemia. B Not suitable for patients requiring fibre free diet.
FORTISIP YOGURT STYLE
Nutricia
1O 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.
FREBINI ENERGY
Fresenius Kabi
1O Oral/enteral nutritional. Protein (milk) 3.75g,
Nutricia carbohydrate (maltodextrin) 18.8g, fat (vegetable,
1
1O
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.
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
236
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.
Nutricia Oral nutritional. Protein 6g, fat 5.8g, carbohydrate
(FORMERLY KNOWN AS ENLIVE PLUS). Oral nutritional. Energy 305kcal. Protein 9.6g, fat 0g, carbohydrate 65.4g per 200ml. Gluten and clinically lactose free. 1.5 kcal/ml. Unsuitable as a sole nutritional source. 200ml bottle with straw attached (4 flavours), A2.42. S Disease related malnutrition, pre and post operative undernourished patients, inflammatory bowel disease, total gastrectomy, dysphagia, bowel fistulae, anorexia nervosa, short bowel syndrome, intractable malabsorption, fat intolerance, convalescence, oncology, taste alterations/aversions to ’milky’ supplements. Q Under 5 years, caution. Under 1 year, not recommended. Abbott
1O
Nutricia flavours and neutral). Nutritionally complete.
1O
FORTIJUCE
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. ALSO FORTINI MULTI FIBRE As above with 1.5g
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 Tetra, A2.63. S Energy dense, low volume, EPA enriched feed indicated for the dietary management of patients with cancer related ENSURE PLUS HP Abbott malnutrition. Q 3-6 years, caution. Under 3 years, not 1O suitable. Oral nutritional. Energy 250kcal. Protein 15.8g, fat 6.6g, carbohydrate 31.8g per 200ml. Gluten- and FORTICREME COMPLETE Nutricia clinically lactose-free. 1.25 kcal/ml. Nutritionally 1O complete. 200ml bottle with straw attached (2 Oral nutritional. Protein 12g, fat 6g, carbohydrate flavours), A2.07. 24g per 125g, vitamins, minerals, trace elements, S Acute or chronic wounds or patients gluten-free. 201kcal/125g (4 flavours). 125g, with poor wound healing. A2.34. Q Under 6 years, caution. Under 1 year, S Patients with swallowing difficulties, not recommended. elderly patients with poor appetite. ENSURE PLUS JUCE Abbott B Not lactose-free.
1O
Nutricia
Vitaflo multi fibre per 100ml. Gluten-, lactose-free.
1O
FORTICARE
FORTINI
Nestle Clinical 1 O
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
bottle with straw. 200ml, A2.07. S Dietary management of hypoproteinaemia, wound healing, continuous ambulatory peritoneal dialysis.
MCT) 6.7g per 100ml. Lactose- and gluten- free. Nutritionally complete. Oral- Easy bottle with straw 200ml (2 flavours) 1.5kcal/ml, A3.13. Liquid tube feed- 500ml Easy Bag, A8.49.
1O ALSO FREBINI ENERGY FIBRE Protein (milk) 3.75g,
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 carbohydrate (maltodextrin) 18.8g, fat (vegetable, MCT) 6.7g, fibre 1.1g per 100ml Lactose- and gluten- free. Nutritionally complete. OralEasyBottle with straw 200ml (2 flavours) 1.5kcal/ ml, A3.20.Liquid tube feed- 500ml EasyBag, A9.09.
1O ALSO FREBINI ORIGINAL Protein (milk) 2.5g, carbohydrate (maltodextrin) 13.5g, fat (vegetable, MCT) 4g, fibre 1.1g per 100ml. lactose- and gluten- free. Nutritionally complete. Liquid tube feed. Easybag 500ml, A7.22.
1O ALSO FREBINI ORIGINAL FIBRE Protein (milk) 2.5g, carbohydrate (maltodextrin) 12.5g, fat (vegetable MCT) 4g, fibre 1.1g per 100ml. Lactose- and gluten- free. Nutritionally complete. Liquid tube feed. Easybag 500ml, A7.52. S Disease related malnutrition. Suitable for children 1-10 years or 8-30kg. P Unsuitable. Q Under 1 year or 8kg, unsuitable.
FOODS 10.6 complete. Oral- EasyBottle with straw 200ml (6 flavours) 1.0kcal/ml, A1.90. Liquid tube feed500ml EasyBag, A4.60; 1L, A9.21; 1.5L, A13.81.
1O ALSO FRESUBIN ORIGINAL FIBRE Protein (milk) 3.8g, carbohydrate (maltodextrin) 13.8g, fat (vegetable, MCT) 3.4g, fibre (inulin, wheat dextrin fibre, cellulose) 1.5g,Gluten- and lactose-free. Nutritionally complete. Liquid tube feed 500ml EasyBag, A5.57; 1L, A10.92; 1.5L, A15.72. 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.
1O
ALSO FRESUBIN HP ENERGY Protein (milk) 7.5g, carbohydrate (maltodextrin) 17g, fat (sunflower oil, MCT) 6g, vitamins, minerals, trace elements per 100ml, lactose-low (0.03%), gluten-free. Liquid 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, short bowel syndrome, intractable malabsorption, ALSO FRESUBIN 1000 COMPLETE Protein (milk, soya) 5.5g, carbohydrate (maltodextrin) 12.5g, fat pre-operative preparation of undernourished (vegetables oils, MCT) 3.1g, fibre (inulin, wheat patients, IBD, total gastrectomy, bowel fistulae. dextrin fibre, cellulose) 2g, vitamins, minerals per CAPD and haemodialysis. Elderly. 100ml, lactose- and gluten- free liquid feed. Liquid Q Under 5 years, caution. Under 1 year, tube feed (neutral). 100kcal/100ml. Nutritionally unsuitable. complete. EasyBag tube feed 1L, A13.02. 1O S Short bowel syndrome, intractable ALSO FRESUBIN ENERGY Protein (milk) 5.6g, fat malabsorption, pre-operative preparation of (vegetable, MCT) 5.8g, carbohydrate (maltodextrin) 18.8g per 100ml, lactose and gluten patients who are undernourished, IBD, total free. Nutritionally complete. Oral- EasyBottle with gastrectomy, bowl fistulae and disease related malnutrition. straw 200ml (8 flavours and neutral) 1.5kcal/ml, Q Under 5 years, caution. Under 1 year, A2.26. Liquid tube feed- 500ml EasyBag A5.99; unsuitable. A 1L, 11.87; 1.5L, 14.04. 1O S Short bowel syndrome, intractable ALSO FRESUBIN 1200 COMPLETE Protein (milk) malabsorption, pre-operative preparation of 6g,carbohydrate (maltodextrin) 15g, fat (vegetable patients who are undernourished, IBD, total oil, fish oil) 4.1g, fibre (inulin,wheat dextrin fibre, gastrectomy, bowel fistulae and disease related cellulose) 2g, vitamins, minerals and trace malnutrition. CAPD and haemodialysis. elements per 100mls. Lactose and gluten free Q Under 5 years, caution. Under 1 year, liquid tube feed.120kcal/100ml. Nutritionally unsuitable. complete. EasyBag 1L, A15.12. 1O S As per Fresubin 1000 Complete. ALSO FRESUBIN ENERGY FIBRE Protein (milk) Q Under 5 years, caution. Under 1 year, 5.6g, fat (vegetable, MCT) 5.8g, carbohydrate unsuitable. (maltodextrin) 18.8g, fibre (inulin, wheat dextrin 1 O fibre, cellulose) 2g. Lactose and gluten free. ALSO FRESUBIN 2250 COMPLETE Protein (milk) Nutritionally complete. Oral- EasyBottle with straw 5.6g, carbohydrate (maltodextrin) 18.8g, fat 200ml (6 flavours) 1.5kcal/ml, A2.52.Liquid tube feed- 500ml EasyBag, A6.16; 1L, A12.32; 1.5L, See (vegetable, MCT) 5.8g. Fibre (inulin, wheat dextrin, cellulose) 2g. Lactose and gluten free. Nutritionally Fresubin 2250 Complete. complete. Liquid tube feed 1.5L EasyBag, A15.72. S Short bowel syndrome, intractable S Short bowel syndrome, intractable malabsorption, pre-operative preparation of malabsorption, pre-operative preparation of patients who are undernourished, IBD, following patients who are undernourished, IBD, following total gastrectomy, bowl fistulae and disease total gastrectomy, bowel fistulae and disease related malnutrition. related malnutrition. Q Under 5 years, caution. Under 1 year, Q Under 5 years, caution. Under 1 year, unsuitable. unsuitable. 1O ALSO FRESUBIN ORIGINAL Protein (milk) 3.8g, GA GEL Vitaflo carbohydrate (maltodextrin) 13.8g, fat (vegetable, 1O MCT) 3.4g. lLactose and gluten free. Nutritionally
Oral nutritional. Powdered lysine free tryptophane low protein substitute. 30 x 20g, A203.69. S Glutaric aciduria type 1. Q Suitable 12 months-10 years.
GALACTOMIN 17
SHS
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.
1O ALSO GALACTOMIN 19 FRUCTOSE FORMULA Protein/casein 14.6%; carbohydrate 49.7%; fat/ vegetable oils 30.8%; with vitamins, minerals, trace elements 534kcal/100g. Nutritionally complete formula containing fructose, minimal levels of lactose, glucose and galactose. 400g, A45.45. S Glucose with galactose intolerance.
GENERAID
SHS
1O Whey protein (branched chain amino acids, essential amino acids), carbohydrates, fat, vitamins, minerals (low in Na+) and trace elements. Powder. 400g, A22.48. S Hepatic disorders; as sole source of nutrition or supplementary feed in children over 1 and adults. Q Children under 1 years, unsuitable.
GLUCERNA SR
Abbott
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.
1O ALSO GLUCERNA Energy 98kcal. Protein 4.18g, fat 5.44g, carbohydrate 8.14g, fibre 1.44g per 100ml. Gluten- and clinically lactose-free. 1.0kcal/ml. Nutritionally complete. Oral: 250ml can (flavoured), A2.60. Enteral: Ready-to-hang-500ml, A5.20. S Impaired glucose tolerance, type I and type II diabetes mellitus and stress-induced hyperglycaemia. Q Under 2 years, not recommended. Under 6 years, use with caution.
GLUTAFIN
Nutricia
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.
HCU EXPRESS
Vitaflo
1O Oral nutritional. Essential/non-essential amino
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
237
10.6 FOODS
DIETETICS free. 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.
acids, carbohydrates, minerals, trace elements, vitamins and DHA. Methionine free. Sachets (unflavoured). Not nutritionally complete. 30 x 25g, A335.27. S Proven homocystinuria. Q Under 8 years, not recommended.
1O ALSO HCU GEL Sachets (unflavoured). Not nutritionally complete. 30 x 20g, A199.23. Q Under 12 months, not recommended.
1O
ALSO JEVITY 1.5KCAL Energy 152 kcal. Protein 6.38g, carbohydrate 20.1g, fat 4.9g, fibre 2.2g (of 1O 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, A19.07. V Suitable for people aged 3 years and above. S Conditions requiring long-term feeding with increased needs, impaired bowel function, HCU LV SHS neurological disorders. Q Under 10 years, caution. Under 2 years, 1O not recommended. Oral nutritional. Concentrated, low volume, 1O methionine-free formula. Sachets (2 flavours). 30x28g, A497.66. ALSO JEVITY PROMOTE Energy 101 kcal. Protein S Homocystinuria in children over 8 years 5.55g, fat 3.32g, carbohydrate 12.0g, fibre 1.7g (of and adults. which FOS 0.7g) per 100ml. Gluten- and clinically lactose-free. Nutritionally complete in 1000ml. INFASOY Cow & Gate Ready to hang-1L , A12.22. S Long term feeding for stroke, elderly, 1O Oral nutritional. Protein (soya, methionine) 15.4%, neurological disorders, post operative, weight maintenance. carbohydrate (glucose syrup) 53%, fat (vegetable oils) 52%, vitamins and minerals (28.3%). Milk free Q Under 10 years, caution. Under 2 years, not recommended. soya based protein formula. Suitable from birth and for lacto-vegetarians. 499Kcal/100g. JUVELA SHS Nutritionally complete. (OTC)900g, A9.52. S Cowsâ&#x20AC;&#x2122; milk intolerance, galactosaemia, 1O galactokinase deficiency, lactose intolerance. JUVELA GLUTEN FREE. Oral nutritional. Gluten free products. White/fibre loaf (sliced)-400g, INFATRINI Nutricia A 2.82; white/fibre rolls-5x85g-A4.88; fibre mix1O 500g, A3.55. Oral/enteral nutrition. Protein 2.6g, carbohydrate 1O 10.3g, fat 5.4g, prebiotics 0.8g, vitamins, minerals, ALSO JUVELA LOW PROTEIN Low phenylalanine trace elements per 100ml; gluten-free. 100kcal/ products. Bread rolls-5x70g, A5.10; loaf-400g, 100ml. Nutritionally complete. Glass bottle 100ml, A2.74, mix-500g, A8.70; cookies (variety)-125g, A1.51 (non-GMS); plastic bottle 200ml, A2.65 A6.49. (GMS); tube feed pack 500ml, A6.63 (GMS). S Disease related malnutrition, failure to KETOCAL SHS thrive, increased energy requirements and/or fluid 1O restrictions. Oral nutritional. Milk protein with amino acids, Q Suitable for infants from birth to 12 vitamins, minerals and trace elements. High fat, months or up to 8kg body weight. low carbohydrate powder in 2 flavours. 300g, A30.86. ISOLEUCINE AA SUPPLEMENT S Used to administer classical ketogenic Vitaflo diet for epilepsy in children over 1 year and 1O adults. Oral nutritional. Isoleucine 50mg on carbohydrate Q Infants under 1 year, unsuitable. base. Sachets. Not nutritionally complete. 30 x 4g, A56.32. KEYOMEGA Vitaflo S Maple syrup urine disease. 1O Q Under 12 months, not suitable. Oral nutritional. Powdered blend of arachidonic JEVITY Abbott acid and decosahexanoic acid. Sachets of powder. 30 x 4g, A40.95. 1O S Disorders where supplementation of Enteral nutritional. Protein 4.0g, fat 3.47g, AA/DHA is required. 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.
1O 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 lactose-
238
LEUCINE AA SUPPLEMENT
Vitaflo
1O Oral nutritional. Leucine 100mg on a carbohydrate base. Sachets of powder. 30 x 4g, A60.78. S Inborn errors of protein metabolism.
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
SHS
1O 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
SHS
1O 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.
1O ALSO PKU LOPHLEX LQ Essential and nonessential amino acids, carbohydrates, vitamins, minerals and trace elements. Low calorie, low volume, ready to drink phenylalanine free protein substitute. 4 flavours. PKU Lophlex LQ10 (10g protein): 60 x 62.5ml, A327.61; PKU Lophlex LQ20 (20g protein): 30 x 125ml, A327.61. S Phenylketonuria in children over 4 years and adults. Q Under 4 years, not suitable.
LOPROFIN
SHS
1O
Oral nutritional. Lactose-free, gluten-free, low phenylalanine, low protein products. Loaf (sliced)400g, A2.74; wafers-100g, A2.65; biscuits: Sweet150g, A2.75; choc-125g, A2.75; cookies-100g, A5.08; crackers (plain/herb): 150g, A3.75; crunch bar-8x41g, A16.15; duobar (variety) -8x45g, A16.15; wafers (variety)-100g,A2.65; breakfast cereal-375g, A8.49; part baked rolls/rolls-4 x 65g, A4.06; PKU milk-200ml, 79c; snopro-200ml, A1.29; mix-500g A8.70; snack pots-47g, A4.80; rice- 500g, KINDERGEN SHS A 9.06; 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. S Phenylketonuria, other amino acid vitamins, minerals and trace elements with low abnormalities, renal and liver failure, liver levels of K+, Cl, Ca++, phosphorus and vitamin A. cirrhosis. Nutritionally complete powdered feed. 400g, A29.85. MAPLEFLEX SHS S Chronic renal failure in infants and 1O children. Oral nutritional. Essential and non-essential amino P Unsuitable.
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 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.
acids, carbohydrate, fat, vitamins, minerals and trace elements. Leucine-, isoleucine- and valinefree. Protein 29g/100g. 390kcal/100g. 30x29g, A213.53. S Maple syrup urine disease in children aged 1-10 years.
MAXAMAID 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 (flavoured and unflavoured) Age range 1-8 years. 500g, A60.30. S Phenylketonuria
MCT DUOCAL 1O
MCT OIL
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
1O
XP MAXAMUM. Oral nutritional. Essential/non 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).
Oral nutritional. Carbohydrate (maltodextrin) 59%, 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.
1O
ALSO MCT PEPDITE 1+ Carbohydrate (maltodextrin) 59%, fat (83% MCT, 17% LCT) 1O (sunflower, coconut oil) 18%, protein 13.8%, vitamins, minerals, trace elements. Lactose, ALSO MSUD MAXAMUM Essential/non-essential amino acids, carbohydrate, vitamins, minerals and sucrose, milk protein free powder. 453kcals/ trace elements. Leucine, isoleucine and valine free 100mls. Nutritionally complete for children 2 years and older. 400g, A20.99. powder (2 flavours). 500g, A161.75. S Whole protein intolerance, short bowel S Maple syrup urine disease (patients syndrome, intractable malabsorption, aged over 8 years). inflammatory bowel disease, bowel fistulae, fat MAXIJUL SUPER SOLUBLE SHS absorption difficulties.
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.
ALSO MMA/PA GEL Methionine, threonine, valine free and isoleucine low protein substitute containing essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. Unflavoured powder in sachets. 20g-30, A184.42 S MMA and PA. Q Aged 12 months to 10 years.
MODJUL FLAVOUR
SHS
SHS 1 O
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).
Vitaflo
1O
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.
1O
1O
MMA/PA EXPRESS
Oral nutritional. Methionine, threonine, valinefree and isoleucine low protein substitute. Powder. 25g-30, A349.13. S Methylmalonic acidaemia (MMA) and propionic acidaemia (PA). Nutricia V Aged 8 years and above.
1O
SHS
Q Over 10 years, not suitable.
METABOLIC MINERAL MIXTURE SHS
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
Nestle Clinical
1O 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 Crohn’s disease. Q Under 5 years, caution. Infants under 1 year, unsuitable.
MONOGEN
SHS
1O Oral nutritional. Whole whey protein, low in long chain triglycerides (LCT) and high in medium chain triglycerides (MCT). Nutritionally complete low fat powdered feed. 400g A20.88. S Lymphatic disorders such as hyperlipoproteinaemia type 1, intestinal lymphangiectasia, chylothorax, intractable malabsorption with steatorrhea and post operative feeding in short gut syndrome. As complete nutritional support or supplement in infants and children.
MSUD EXPRESS
Vitaflo
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 MCT STEP 1 Vitaflo trace elements. Phenylalanine free drink in 3 1O flavours. 30x29g, A133.16. Oral nutritional. Nutritionally complete powdered S Phenylketonuria in children aged 1-10 feed, containing whole protein, carbohydrate, fat years. high in medium chain triglycerides and low in P Not suitable.
MSUD III
SHS
1O Oral nutritional. Essential/non-essential amino acids, Ca++, phosphorus. Leucine, isoleucine and
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
239
10.6 FOODS
DIETETICS
valine-free. Powder 326kcals/100ml. Not nutritionally complete. 500g, A200.11. S Maple syrup urine disease.
NEOCATE 1O
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. Protein 13%, carbohydrate (maltodextrin) 54%, fat (coconut oil, sunflower oil, canola oil, LCPs), minerals, vitamins and trace elements. Amino acid based nutritionally complete hypoallergenic infant formula. Lactose-, sucroseand gluten free. 70kcal/100ml when reconstituted. 400g, A31.23. S Infants up to 1 year of age with whole protein intolerance including cowâ&#x20AC;&#x2122;s milk and other food allergy, short bowel syndrome, intractable malabsorption, inflammatory bowel disease, bowel fistulae.
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.
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. NUTRINI Nutricia Nutritionally complete. 500ml, A10.15. S Disease related malnutrition and 1O 1O patients who require fluid restriction. ALSO NEOCATE ACTIVE Carbohydrate 45.5%, Enteral nutritional. Protein (caseinate) 2.75g, 1 O Protein (amino acids) 11%, Fat 43.5% minerals, carbohydrate (maltodextrin) 12.3g, fat 4.4g per vitamins and trace elements with enhanced levels 100ml plus vitamins, minerals, trace elenents. ALSO NUTRISON MCT Protein (whey, casein) 5g, of iron, calcium and phosphate. Amino acid based Gluten and lactose free. 1kcal/ml. Nutritionally carbohydrate 12.6g, fat 3.3g (MCT 2.3g)/100ml hypoallergenic formula. 100kcal/100ml when plus vitamins, minerals, trace elements. Glutencomplete. 200ml glass bottle, A3.01; 500ml pack, A A reconstituted. 63g sachets, 5.13 (2 flavours: and lactose-low. 1kcal/ml (flavoured). 1L, A10.53. 7.54. unflavoured and blackcurrant). S Short bowel syndrome, intractable S Disease related malnutrition. S As a supplement to the diet for children Q Infants under 1 year, unsuitable. malabsorption, pre-operative preparation of aged 1-10 years with the following: Whole protein 1 O undernourished patients. Inflammatory bowel intolerance, food allergy, intractable disease, total gastrectomy. Dysphagia, bowel ALSO NUTRINI ENERGY Protein (caseinate) 4.1g, malabsorption, inflammatory bowel disease, short carbohydrate (maltodextrin) 18.5g, fat 6.7g/100ml fistulae, anorexia nervosa. Neoplastic related bowel syndrome and bowel fistulae. plus vitamins, minerals, trace elenents. Gluten and cachexia. 1O 1O lactose free. 200ml glass bottle, A3.70; 500ml ALSO NEOCATE ADVANCE Carbohydrates 58.4%, pack, A9.45. ALSO NUTRISON PROTEIN PLUS Protein (casein) protein 10%, fat 14% (MCT 35%, LCT 65%) 6.3g, carbohydrate (maltodextrin) 14.2g, fat 4.9g/ S Children with disease related vitamins, minerals and trace elements. Amino acid malnutrition on a fluid restricted and/or with 100ml plus vitamins, minerals, trace elements. based nutritionally complete hypoallergenic Gluten- and lactose-free.1.25kcal/ml. 500ml, A5.43; increased nutritional requirements. formula. 100kcal/100ml when reconstituted. 1L, A11.58. Q Infants under 1 year, unsuitable. A Banana/vanilla 50g, 3.43; unflavoured 100g, S Disease related malnutrition combined 1O A7.90. with moderate stress. ALSO NUTRINI MULTI FIBRE Protein 2.75g, S Whole protein intolerance, food allergy, carbohydrate (maltodextrin) 12.3g, fat 4.4g, fibre 1O intractable malabsorption, inflammatory bowel ALSO NUTRISON PROTEIN PLUS MULTI FIBRE (soy, arabic gum, starch, cellulose, inulin, disease, short bowel syndrome and bowel fistulae. oligofructose) 0.75g/100ml plus vitamins, minerals, Protein (caseinates) 6.3g, carbohydrate Can be used as a sole source of nutrition in (maltodextrin) 14.1g, fat 4.9g, fibre 1.5g (soy trace elements. Gluten and lactose free. 1kcal/ml. children age 1-10 years. polysaccharide, arabic gum, starch, inulin, 200ml glass bottle, A3.35; 500ml pack, A8.38. cellulose, oligofructose) 1.5g/100ml plus vitamins, S Disease related malnutrition/impaired NEPRO Abbott bowel function in children ages 1-6 years or 8minerals, trace elements. Gluten- and lactosefree.1.25kcal/ml. 1L, A12.73. 1O 20kg body weight. S Disease malnutrition combined with Q Infants under 1 year, unsuitable. Oral/enteral nutritional. 200kcal. Protein 7.0g, fat moderate stress. 9.6g, carbohydrate 20.6g, fibre 1.56g (of which NUTRISON RANGE Nutricia 1 O FOS 1.56g) per 100ml; gluten- and clinically lactose-free. 2.0kcal/ml. Nutritionally complete. ALSO NUTRISON 1200 COMPLETE MULTI FIBRE 1O Oral: 200ml pack with straw attached (2 flavours), NUTRISON STANDARD. Enteral nutritional. Protein Protein 5.5g, carbohydrate 15g, fat 4.3g, multi A3.33, Enteral: Ready-to-Hang- 500ml, A7.64. fibre 2g per 100ml plus vitamins, minerals and 4g, carbohydrate 12.3g, fat 3.9g/100ml plus trace elements. Gluten- and lactose-free. 1.2kcal/ S Acute or chronic renal disease, renal vitamins, minerals, trace elements. Gluten- and ml. 500ml, A6.40; 1L, A12.78; 1.5L, A18.65. failure and dialysis patients. lactose-free. 1kcal/ml. 500ml, A5.41; 1L, A9.51; Q Under 5 years, caution. Under 1, year S Long term feeding for critically ill, 1.5L, A14.25. not recommended. S Disease related malnutrition, patients at stroke, elderly, CVA, neurological disorders. D Infants under 1 year, unsuitable. risk of disease related malnutrition. NUTILIS Nutricia 1 O B Children 1-6 years, caution. 1O ALSO NUTRISON ENERGY Protein 6g, NUTRODRIP STANDARD Novartis Thickening agent. Carbohydrate (modified maize carbohydrate 18.5g, fat 5.8g/100ml plus vitamins, starch) 90g per 100g; gluten and lactose free; minerals and trace elements. Gluten- and lactose- 1 O powder. 360kcal/100g. Instant food and fluid Oral nutritional. Protein 20.3g, fat 17.4g, free. 1.5kcal/ml. 500ml, A6.32; 1L, A11.62; 1.5L, A17.43. thickener 9gx20, A 7.31; 225g, A5.81; 500g, carbohydrate 70.4g per 500ml; lactose- and A12.90. gluten-free. Nutritionally complete. Flexibag-15 x S Increased energy and protein S Thickening of food and fluid in 0.5L, A59.23; 6 x 1.5L, A71.00. requirements e.g. burns, sepsis, trauma, patients dysphagia. S Existing malnutrition or those at risk of requiring fluid restriction or overnight feeding. Q Under 3 years, unsuitable. malnutrition e.g. dysphagia, short bowel 1O syndrome, intractable malabsorption, preoperative ALSO NUTRISON ENERGY MULTI FIBRE Protein NUTRAMIGEN 1 Mead Johnson (casein) 6g, carbohydrate (maltodextrin) 18.5g, fat preparation of patients who are undernourished, inflammatory bowel disease, total gastrectomy, 1O 5.8g, fibre 1.5g (soy, arabic gum, starch, inulin, bowel fistulae, disease related to malnutrition. cellulose, oligofructose) 1.5g/100ml plus vitamins, Oral nutritional. Protein (casein, amino acids)14g, minerals, trace elements. Gluten- and lactose-free. 1 O carbohydrate (glucose, corn starch) 55g, fat (vegetable oils) 25g, vitamins, minerals, trace 1.5 kcal/ml. 500ml, A6.99; 1L, A12.92; 1.5L, ALSO NUTRODRIP ENERGY Protein 29g, fat 31g,
240
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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
DIETETICS
FOODS 10.6
carbhydrate 100g with vitamins, minerals and trace elements per 500ml. 1.6kcal/ml. Nutritionally complete. Flexibag-15 x 0.5L, A69.33. S When a high energy diet is required eg catabolic and burn patients, polytrauma sepsis, postoperative complications, cancer, malnutrition or patients requiring fluid retention.
OSMOLITE
S Feed suitable for children 8-30kg (110years) for use in disease related malnutrition, failure to thrive, malignancy, pre and postoperative, trauma, fluid restriction and/or increased nutritional requirements. P Not applicable. Q Under 1year, not recommended.
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
LCT, vegetable oils), carbohydrate (38% lactose, 62% glucose syrup), vitamins, minerals. Whole milk protein- and soya-free. Iron enriched followon formula. Use as part of mixed diet from 6 months. 450g, A7.83. S Cows’ milk protein allergy/soya allergy in older infants, children and adults.
PEPTI-JUNIOR
Cow & Gate
1O Oral nutritional. Protein (whey 80%, short chain peptide 20%, free amino acids), carbohydrate (q99% glucose syrup), fat (50% MCT, 50% LCT), vitamins, minerals, clinically insignificant lactose. 450g, A13.05. S Multiple/severe food intolerance, short bowel syndrome, cystic fibrosis, inflammatory bowel disease, severe protein-energy malnutrition, pre- and post-operative nutrition.
PEPTISORB
Nutricia
1O Enteral Nutritional. Protein 4g (whey hydrolysate),
SHS carbohydrate (17.6g), fat 1.7g (MCT 0.8g)/100ml
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. S Infants with severe impairment of the 1O Oral nutritional. Essential and non-essential amino gastrointestinal tract e.g. malabsorption, bowel fistulae, short bowel syndrome, protracted acids, phenylalanine-free. 334kcals/100g. Suitable diarrhoea. for all age ranges. 500g A148.34. 1O S Phenylketonuria. ALSO PEPDITE 1+ Low molecular weight peptides PAEDIASURE Abbott (non-milk derived), essential amino acids, carbohydrate, fat, vitamins, minerals and trace 1O elements. Nutritionally complete powder. 15x57g, Oral/enteral nutritional (paediatric). Energy A50.61; banana flavour. 400g, A20.26; 202kcal. Protein 5.6g, fat 9.96g, carbohydrate unflavoured. 22.4g per 200ml. Gluten- and clinically lactoseS Severe gastrointestinal tract impairment free. 1.0kcal/ml. Nutritionally complete. Oral: requiring a semi-elemental diet e.g. crohn’s 200ml pack with straw attached (4 flavours), disease, malabsorption, bowel fistulae or short A2.98. Enteral: Ready-to-Hang- 500ml (flavoured), bowel syndrome in children over 1 year. A7.45. Q Children under 1 year, not suitable. S Feed suitable for children 8-30kg (110years) for use in disease related malnutrition, PEPTAMEN Nestle Clinical failure to thrive, malignancy, pre and 1O postoperative, trauma, poor appetite. Oral nutritional. Protein 4g, carbohydrate 12.7g, P Not applicable. fat 3.7g, vitamins, minerals per 100ml, gluten- and Q Under 1 year, not recommended. lactose-free. Liquid 100kcal/100ml (flavoured and 1O ALSO PAEDIASURE FIBRE Energy 200kcal. Protein unflavoured). Nutritionally complete. Flavoured-4 x 200ml, A14.52; Unflavoured-375ml, A5.96; 5.6g, fat 9.96g, carbohydrate 21.8g, fibre 01.46g Dripac-flex- 500ml, A7.38. (of which FOS 0.46g) per 200ml. Gluten- and S Acute inflammatory bowel disease, clinically lactose-free. 1.0kcal/ml. Nutritionally complete. Oral: 200ml pack with straw attached (2 intractable malabsorption, pancreatic insufficiency, radiation enteropathy, short bowel syndrome. flavours), A3.30. Enteral: Ready-to-Hang -500ml Q Under 5 years, caution. Infants under 1 (flavoured), A8.26. year, unsuitable. S Feed suitable for children 8-30kg (110years) for use in disease related malnutrition, PEPTI FIRST Cow & Gate failure to thrive, malignancy, pre and 1O postoperative, trauma with impaired bowel function. Oral nutritional. Whey protein (85% short chain P Not applicable. peptides, 15% free amino acids), fat (100% LCT, Q Under 1 year, not recommended. vegetable oils), carbohydrate (38% lactose, 62% glucose syrup), vitamins, minerals. Whole milk 1O protein- and soya-free. Nutritionally complete. ALSO PAEDIASURE PLUS Energy 302kcal. Protein Suitable from 0-6 months. 450g, A9.09. 8.4g, fat 14.9g, carbohydrate 33.4g per 200ml. S Cows’ milk protein allergy. Soya allergy. Gluten and clinically lactose free. 1.5 kcal/ml. 1O Nutritionally complete. Oral: 200ml pack with straw attached (2 flavours), A3.65. Enteral: Ready- ALSO PEPTI FOLLOW ON Whey protein (8% shortto-Hang -500ml (flavoured), A9.32. chain peptides, 15% free amino acids), fat (100%
plus vitamins, minerals and trace elements. Gluten free and low-lactose. 1 kcal/ml. 500ml, A8.08; 1L, A14.86. S Intractable malabsorption, short bowel syndrome, inflammatory bowel disease, bowel fistualae, disease related malnutrition. D Infants under 1 year of age. Galactosaemia. B Children aged 1-6 years.
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, not recommended.
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
SHS
1O Oral nutritional. Essential and non-essential amino acids, carbohydrate, vitamins, minerals and trace elements. 292kcals/100g (3 flavours). 30x19g, A144.72. S Phenylketonuria in children aged 1-10
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
241
10.6 FOODS
DIETETICS S Galactosaemia, galactokinase deficiency, sucrose and/or lactose intolerance with protein
years.
PKU ANAMIX JUNIOR LQ
elements in 2 x 200ml/day. Gluten, lactose, milk and fat free. Oral- EasyBottle with straw 200ml (8 sweet flavours, 1 savoury) 1.5kcal/ml A2.42. protein intolerance. S Short bowel syndrome, intractable malabsorbtion, pre-operative preparation of PRO-CAL POWDER Vitaflo undernourished patients, inflammatory bowel disease, total gastrectomy, bowl fistulae, disease 1O related malnutrition. Oral nutritional. Protein (casein) 13.5g, carbohydrate (lactose) 26.8g, fat (vegetable) 56.2g Q Under 5 years, caution. Infants under 1 year, unsuitable. per 100g. Powder 667kcal/100g. Not nutritionally complete. 510g, A15.49.
SHS intolerance. Impaired fat absorption, with/without
1 Oral nutritional. Liquid phenylalanine free protein substitute containing essential and non essential amino acids, carbohydrates, fat, vitamins, minerals and trace elements in 2 flavours. 36 x 125mls, A208. S Phenylketonuria in children aged 110years. P Not Suitable Q Over 10 years, not suitable
PULMOCARE
1O
ALSO PRO-CAL SHOT Protein (casein) 6.7g, carbohydrate (lactose) 13.4g, fat (vegetable) 28.2g PKU COOLER SYSTEM Vitaflo per 100ml. Creamy white liquid 334kcal/100ml. Available in neutral, strawberry or banana 1O Oral nutritional. Liquid phenylalanine free protein flavours. Not nutritionally complete. 6 x 250ml, A35.55. substitute containing essential and non-essential amino acids, carbohydrate, vitamins, minerals trace S Disease related malnutrition, malabsorption states, other conditions requiring elements and DHA. Foil pouches (4 options). PKU fortification with energy and protein. cooler10 (protein 10g): 30 x 87ml, A149.19. PKU cooler15 (protein 15g): 30 x 130ml, A222.22. PKU Q Infants under 1 year, unsuitable. Strawberry and banana flavour unsuitable under 3 A cooler20 (protein 20g): 30 x 174ml, 298.38. years. S For the dietary management of phenylketonuria in children over 3 years. Firstplay Q PKU Cooler20 not recommended under PROMIN 8 years due to its volume. 1O Oral nutritional. Essential and non-essential amino PKU RANGE Vitaflo acids, carbohydrate, fat, vitamins, minerals and trace elements. Low protein products. Rice 1O PKU EXPRESS POWDER. Oral nutritional. Essential/ pudding mix (4 flavours)-4 x 69g, A7.31; pasta (6 A8.57; pasta imitation rice-500g, types)-500g, non-essential amino acids, carbohydrates, minerals, A8.57; pasta tri-colour (3 types)-500g, A8.57; low trace elements and vitamins. Phenylalanine free. protein & GF cous cous -500g, A8.23; pasta in Sachets (4 flavours, 1 unflavoured). 30 x 25g, sauce (2 flavours) - 4 x 72g, A9.11; burger mix-2 x A209.55. A7.31. 62g, S For the dietary management of 1O phenylketonuria. ALSO PROMIN LOW PROTEIN Essential and nonQ Under 8 years, not recommended. essential amino acids, carbohydrate, fat, vitamins, 1O ALSO PKU START A ready to feed phenylalanine minerals and trace elements. Low protein products. Hot breakfast (4 flavours)-6 x 57g, free infant formula. 6 x 500ml bottles, A43.88. Q Infants from diagnosis to 12 months of A9.11; low protein & GF lasagne sheets-200g, A3.53. age. S Inherited metabolic disorders, renal or 1O liver failure requiring a low-protein diet including ALSO PKU GEL Sachets (2 flavours, 1 phenylketonuria. unflavoured). 30 x 20g, A116.21. S Phenylketonuria in children. Abbott Q Recommended only: 6 months-10 years PROSURE 1O (unflavoured) or 12 months-10 years (flavoured). Oral/enteral nutritional. Energy 125kcal. Protein POLYCAL Nutricia 6.65g, fat 2.56g, carbohydrate 18.3g, fibre 2.07g (of which FOS 1.1g), per 100ml. Gluten- and 1O clinically lactose-free. 1.25kcal/ml. Nutritionally Oral nutritional. Maltodextrin 61.5%. 250kcal/ complete. Oral: 240ml pack with straw attached (2 100ml ready to use high energy carbohydrate flavours), A4.29. Enteral: Ready-to-Hang based drink, lactose, galactose, sucrose, gluten, (flavoured) -500ml, A.8.94. protein free, low electrolyte (1 flavour and neutral). Not nutritionally complete. 200ml, A1.68. S Dietary management of cancer induced S Renal failure, liver cirrhosis, disaccharide weight loss. Q Under 4 years, caution. Under 1 year, intolerance (without isomaltose intolerance), not recommended. hypoglycaemia, amino acid metabolism disorders and protein intolerance, malabsorption states, PROTIFAR Nutricia conditions requiring a high energy, low fluid 1O intake. Oral nutritional. Protein 88.5%. Powder 370kcal/ PREGESTIMIL Mead Johnson 100g. 225g, A9.67. S Hypoproteinaemia, high protein 1O Oral nutritional. Protein (casein, amino acids) 14g, requirements e.g. impaired wound healing. carbohydrates (glucose, corn starch) 51g, fat PROVIDE XTRA Fresenius Kabi (medium chain triglycerides, vegetable oils) 28g, 1O vitamins, minerals, trace elements. Lactose-, sucrose-, fructose- and gluten-free. Powder Oral nutritional. Protein (soya, pea) 500kcal/100g. Nutritionally complete. 400g, 3.75g,carbohydrate (sucrose, maltodextrin) 27.5g. A12.80. Nutritionally complete for vitamins and trace
242
Abbott
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.
QUICKCAL
Vitaflo
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.
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
Novartis
1O Thickening agent. Instant food thickener with vitamins and minerals (neutral). Tin-12 x 227g, A68.26. S Thickening of foods in dysphagia.
RESPIFOR
Nutricia
1O Oral nutritional. Protein 7.5g, carbohydrate 22.5g, fat 3.3g per 100ml. Gluten free. 1.5kcal/ml. Tetra (3 flavours)-125ml, A2.55. S High protein and carbohydrate, low fat feed for patients with respiratory disease/ insufficiency. Q 3-6 years, caution. Under 3 years, not suitable.
SANDOSOURCE GI CONTROL Novartis
1 Oral/enteral nutritional. Protein 20.5g, fat 17.5g, carbhydrate 72g, soluble fibre 10.8g (Benefiber), vitamins, minerals, trace elements per 500ml. Flexibag-15 x 0.5L, A87.99; 6 x 1.5L, A105.67. S Gut mucosal growth and support in the treatment of diarrhoea, long term enteral feeding.
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
DIETETICS SCANDISHAKE MIX
FOODS 10.6 Nutricia
TENTRINI RANGE
Nutricia
1O
1O
Oral nutritional. Protein 4g, carbohydrate 58g, fat 21g, vitamins, minerals per 85g (one serving). 437kcals/89g sachet (5 flavours, 1 unflavoured). 6, A17.61. S Increased energy requirements e.g. postop, oncology, cystic fibrosis. P Mix sachet with 240ml whole milk. Q Under 5 years, half sachet mixed with 240ml milk.
TENTRINI. Enteral nutritional. Protein 3.3g, carbohydrate 12.3g, fat 4.2g per 100ml plus vitamins, minerals, trace elements. Gluten-, lactose-free. 1kcal/ml. 500ml, A6.35.
SMA HIGH ENERGY
1O
VITAJOULE
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. Q Suitable for children aged 0-18 months.
1O
1O ALSO TENTRINI ENERGY Protein 4.9g, carbohydrate 18.5g, fat 6.3g per 100ml plus vitamins, minerals, trace elements. Gluten-, lactose-free. 1.5kcal/ml. 500ml, A7.86. 1.1g multi fibre per 100ml. Gluten-, lactose-free. 1kcal/ml. 500ml, A6.95.
1O
1O
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 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.
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
Abbott ALSO TYR GEL Unflavoured powder. 30 x 20g,
1O 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), A3.62. S Acute or chronic renal failure (without dialysis), acute and chronic liver disease or any condition requiring a high protein, low electrolyte, high calorie supplement. Q Under 5 years, caution. Under 1 year, not unsuitable.
VITAQUICK
Vitaflo
1O
Thickening agent. Carbohydrate (modified maize) 95g, Na+ 5mmol, K+ 0.01mmol, protein and fat traces only. Powder 400kcal/100g. Not nutritionally complete. 10 x 300g, A86.40. S Dietary management of dysphagia. Vitaflo Q Under 1 year, not recommended.
1O
SUPLENA
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.
ALSO TENTRINI ENERGY MULTI FIBRE As for Tentrini Energy with 1.1g multi fibre/100ml. Gluten-, lactose-free. 1.5kcal/ml. 500ml, A8.64. Vitaflo S Disease related malnutrition for children VITAPRO 7-12 years (or 21-45kg). 1O D Infants under 1year. Oral nutritonal. Whey protein. Powder. 225g tub, A9.67. THICK & EASY Fresenius Kabi S Hypoproteinaemia.
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. SHS
Vitaflo
1O
SMA ALSO TENTRINI MULTI FIBRE As for Tentrini with
1O
A8.26. S Protein restricted diet. Q Under 1 year, not recommended.
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.
WYSOY
Wyeth
1O Oral nutritional. Protein (soya, L-methionine) 16%, carbohydrate (corn syrup, sucrose) 52%, fat (oleic, soya, coconut oil) 27%, vitamins, minerals, trace elements. Milk protein-, lactose- and gluten-free. Powder. 2.11MJ/100g. Nutritionally complete. (GMS) 430g, A4.76; (OTC) 860g, A9.96. S Milk or lactose intolerance, galactosaemia, galactokinase deficiency.
XMET HOMIDON
SHS
1O
Oral nutritional. Essential and non-essential amino acids, taurine and carnitine. Methionine-free. White powder. Protein 77g/100g. 326kcal/100g. 500g A200.10. Dietary management of vitamin B6 nonTYROSINE AA SUPPLEMENTVitaflo S responsive homocystinuria or 1O hypermethioninaemia. Oral nutritional. L-Tyrosine 1g on a carbohydrate base. Sachets of powder. 30 x 4g, A58.23. ZAVESCA Actelion SURVIMED OPD Fresenius Kabi S Inborn errors of protein metabolism. 2MT Q From 12 months of age. 1O Enzyme inhibitor. Miglustat 100mg. White cap. Oral nutritional. Protein (amino acids, VALINE AA SUPPLEMENT Vitaflo with OGT A918 printed on the cap and 100 on the body. 84, 6767. oligopeptides) 4.5g, carbohydrate (maltodextrin, 1O S Mild to moderate type 1 Gaucher starch) 15g, fat (MCT, soya oil) 2.4g, minerals, Oral nutritional. Valine 50mg on carbohydrate disease. vitamins, trace elements per 100ml, lactose-free. base. Sachets. Not nutritionally complete. 30 x 4g, P 100mg three times a day. 100mg once Liquid tube feed, 100kcal/100ml. Nutritionally A56.32. or twice a day may be necessary in some patients complete. Bottle-500ml, A7.70; EasyBag-500ml, S Maple syrup urine disease. A7.70. because of diarrhoea. Renal impairment: cc 50Q Under 12 months, not suitable. 70ml/min, 100mg twice daily; cc 30-50ml/min, S Short bowel syndrome, intractable 100mg/day. malabsorption, pre-operative preparation of VITABITE Vitaflo R Over 70 years, no experience. undernourished patients, inflammatory bowel 1 O Q Under 18 years, not recommended. disease, total gastrectomy, bowel fistulae and Oral nutritional. Lactose, hydrogenated vegetable B Severe Gaucher disease, no data. disease related malnutrition. Monitor vitamin B12 level regularly. Perform Q Under 5 years, caution. Infants under 1 oil, sucrose, carob flour, lecithin. Chocolate flavoured bar. Not nutritionally complete. 7 x 25g, baseline and repeat neurological evaluation and year, unsuitable. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
243
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
RESPIRATORY
serum transaminases. Increased incidence of mild infection in elderly.
S Acute attacks of bronchial asthma. Treatment of reversible airways obstruction. Prophylactic use before exercise-induced asthma. AEROLIN AUTOHALER CFC-FREE V Acute bronchospasm: 1-2 puffs. Teva Prophylaxis: 1-2 puffs before exercise. Max. 8 puffs in 24 hours. 9MO B Hyperthyroidism. Myocardial Selective b2-agonist. Salbutamol (sulph.) 100mcg/ insufficiency, angina, cardiac arrhythmia, dose. Breath-actuated metered dose aerosol. 200hypertension. Pregnancy, lactation. dose unit-1, A7.55. C Sympathomimetics, b-blockers. S Treatment of reversible airways A Fine tremor, headache, tachycardia, Prophylaxis of exercise-induced 11.1 BRONCHODILATORS, OTHER ANTI- obstruction. palpitations, hypokalaemia, paradoxical asthma. bronchospasm, hypersensitivity, angiodema. ASTHMATICS V Reversible airways obstruction: 100mcg increasing to 200mcg as a single dose if necessary. ALUPENT Boehringer Ing. ACCOLATE AstraZeneca Exercise induced asthma: 100mcg increasing to 200mcg before exercise. Max. 8 puffs in 24 hours. 5 M O 2MO Partially selective b-agonist. Orciprenaline (sulph.) Leukotriene receptor antagonist. Zafirlukast 20mg. B Thyrotoxicosis, angina, severe 10mg/5ml. Sugar-free. 300ml, A2.95. tachycardia. Pregnancy, lactation. White/off-white tab. 56, A23.98. S Bronchospasm in chronic bronchitis, C Non-selective b-blockers, anaesthetics. S Prophylaxis and chronic treatment of asthma, emphysema. A Fine tremor, headache, palpitations, asthma. 1st-line maintenance therapy in patients P 10ml four times daily. tachycardia, hypokalaemia, paradoxical requiring more than prn. bronchodilator. Q Up to 1 year, 2.5-5ml three times daily. bronchospasm. Hypersensitivity and hyperactivity P Initial dose 20mg twice daily. Usual 1-3 years 2.5-5ml four times daily. 3-12 years, 5ml in children. maintenance dose 20mg twice daily; max. 40mg four times daily to 10ml three times daily. twice daily. Teva D Acute coronary disease, Q Under 12 years, not recommended. Over AIROMIR hyperthyroidism, cardiac asthma. 9MO 12 years, same as adults. B Hypertension, diabetes. B Not evaluated in brittle/unstable Selective b2-agonist. Salbutamol (sulph.) 100mcg/ C MAOIs, tricyclics, sympathomimetics. asthma. Pregnancy, lactation. dose. CFC-free metered dose aerosol. 200-dose A Arrhythmias, fine tremor, nervous unit-1, A2.48. A Headache, GI disturbance, elevated tension, headache, peripheral vasodilatation, tachycardia.
assessment of cognitive functions. Male and female patients should use adequate contraception. Pregnancy, lactation. Caution: Renal/hepatic impairment. Severe renal impairment, not recommended. C Cerezyme. A Weight loss/increase, decreased appetite, tremor, dizziness, headache, leg cramps, paraesthesia, peripheral neuropathy, cognitive dysfunction, visual disturbance, GI disorders.
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
244
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 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
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
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
untreated fungal, bacterial, systemic viral infections, ocular herpes simplex. Pregnancy, lactation. C Ketoconazole. A Candidiasis, dysphonia, pharyngitis, headache.
ASMASAL CLICKHALER
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,
11.1
glycosides. A Mild tremor, nervous tension, headache, peripheral vasodilation, hypokalaemia, palpitations, muscle cramps, oropharyngeal irritation, hypersensitivity reaction, paradoxical bronchospasm. UCB
ATROVENT INHALER CFC-FREE Boehringer Ing.
9MO Selective b -agonist. Salbutamol (sulph.) 95mcg per
2 Schering- dose. Dry powder breath-actuated inhaler. 200Plough dose unit, A7.56.
4NO
ANTI-ASTHMATICS
2MO
Anticholinergic. Ipratropium bromide 20mcg/dose. Metered dose inhaler. 200-dose unit, A4.94. S Treatment of bronchospasm in bronchial S Bronchospasm in COPD (chronic asthma, reversible airways obstruction. bronchitis, emphysema) and asthma. P Acute attack, 1 or 2 puffs as necessary. P 1 or 2 puffs three or four times daily. Allergic or exercise-induced asthma, 2 puffs 15 Max. 4 puffs at a time. mins. before challenge. On demand, max. 2 puffs Q Under 6 years, 1 puff. 6-12 years, 1 or 2 four times daily. puffs. Both 3 times daily. Q Acute attack or before exercise, 1 puff 2MO as necessary. If response is inadequate, higher ALSO ATROVENT UDVS 1ML Ipratropium bromide doses can be used.On demand, max. 1 puff four 0.025% (250mcg/ml). Unit dose vials (UDVs) times daily. preservative free. 1ml vial-20, A4.77; 60, A17.70. B Hyperthyroidism, diabetes, severe 2MO cardiovascular disorders, hypertension, ALSO ATROVENT UDVS 2ML Ipratropium bromide phaeochromocytoma. Pregnancy. 0.025% (250mcg/ml). Unit dose vials (UDVs) C Sympathomimetics, b-blockers, preservative free. 2ml vials-20, A5.67; 60, A20.93. xanthines, steroids, diuretics, anaesthetics, cardiac 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.
Anti-Doping Information d
This medicine is permitted but should be declared on the Doping Control Form at the time of testing.
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.
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 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.
BECOTIDE EVOHALER
A&H
4MO AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
245
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
RESPIRATORY
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 4MO dose up to 2mg daily for patients in maintenance ALSO BECOTIDE 250 Beclomethasone therapy with oral steroids. Maintenance: 0.25-1mg dipropionate 250mcg per dose. Metered dose daily. aerosol. 200-dose unit (CFC free), A26.78. B Not indicated for acute dyspnoea or P 1 puff twice daily increasing to 2 puffs status asthmaticus. Caution when switching from two to four times daily according to response. systemic treatment. Systemic effects of inhaled Q Not recommended. corticosteroids may occur, particularly at high B Active or quiescent pulmonary tuberculosis. Pregnancy. Transferring from systemic doses, for prolonged periods. Discontinue immediately if paradoxical bronchospasm occurs. steroids. Monitor HPA axis function regularly in patients at A Hoarseness, candidiasis of mouth and risk of impaired adrenal function (previous throat. Hypersensitivity reactions. prolonged systemic corticosteroid therapy, severe BRICANYL TURBOHALER AstraZeneca hepatic dysfunction). Advise patients to rinse out their mouth properly/brush their teeth after each 5MO admin. to reduce risk of oral candidiasis and Selective b2-agonist. Terbutaline sulph. 0.5mg per hoarseness. Treat acute respiratory tract bacterial dose. Breath-actuated, metered-dose dry powder infections with appropriate antibiotics. Caution: inhaler. 100-dose unit, A10.62 Active and quiescent pulmonary tuberculosis, S Relief and prevention of bronchospasm fungal, viral or other airways infections in bronchial asthma and in chronic bronchitis and (concomitant treatment required). Monitor height other bronchopulmonary disorders in which of children receiving prolonged treatment. bronchospasm is a complicating factor. Pregnancy, lactation (if benefits outweigh risks). V 1 inhalation (0.5mg) as required. Not C Avoid: Ketoconazole, potent CYP3A4 more than 4 inhalations should be necessary in inhibitors (erythromycin, clarithromycin, any 24 hour period. itraconazole, ketoconazole, ritonavir, saquinavir). 5MO Systemic or intranasal steroids. b-2ALSO BRICANYL RESPULES Terbutaline sulph. 5mg sympathomimetics. per 2ml soln. Single dose unit. 20, A4.36. A Oropharyngeal candidiasis, hoarseness, P 5-10mg two to four times daily in cough, oral mucosal irritation, difficulty in nebuliser. swallowing. Q Under 25 kg, use multidose bottles; over 25 kg, 5mg two to four times daily in a nebuliser. COMBINEB Clonmel Corticosteroid. Beclomethasone dipropionate 50mcg, 100mcg per dose. CFC free metered dose aerosol. 50mcg-200-dose unit, A6.43; 100mcg-200dose unit, A12.53. S Bronchial asthma. P 400mcg daily in two, three or four divided doses. Severe cases, initially 600-800mcg daily, reducing according to response. Q 50-100mcg two to four times daily.
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 tocolytic therapy). P Bronchodilation: 0.25mg-0.5mg SC, IM or slow IV inj. up to 4 times daily or 1.5-2.5mg by IV inf. Premature labour: See SPC. Q Over 2 years, 10mcg/kg body weight SC, IM or slow IV inj. up to 4 times daily. Max. single dose 300mcg. B Hyperthyroidism, myocardial insufficiency, thyrotoxicosis, cardiac arrhythmias, severe heart disease (monitor symptoms of worsening), diabetes, acute sever asthma. Pregnancy. Do not use in case of hypertrophic cardiomyopathy. C Avoid non-selective b-blockers. Caution: Sympathomimetics; xanthine derivatives, corticosteroids, diuretics (hypokalaemia). A Tremor, headache, tachycardia, palpitations, muscle spasms, hypokalaemia.
9MO
Selective b2-agonist/anticholinergic. Ipratropium bromide (monohydrate) / salbutamol (sulphate), 0.5mg/2.5mg per 2.5ml. Colourless nebuliser sln in amp. 2.5ml-60, A26.40. S Bronchospasm in patients with COPD who require regular treatment with both ipratropium bromide and salbutamol. P 1 amp. 3 or 4 times daily. Q Over 12 years, as per adults. D Hypertrophic obstructive cardiomyopathy or tachyarrhythmia. B Advise to consult doctor immediately if acute, rapidly worsening dyspnoea or reduced response to treatment occurs. Discontinue immediately if inhalation-induced bronchoconstriction or paradoxical bronchospasm occurs. Assess benefit vs risk: Inadequately controlled diabetes, recent MI, severe organic heart / vascular disorders, hyperthyroidism, phaeochromocytoma, prostatic hypertrophy, bladder outflow obstruction, narrow-angle glaucoma risk. Warn patients not to let Combineb enter the eyes. If acute narrow-angle glaucoma develops, initiate treatment with miotic eye drops and seek specialist advice immediately. May occur: Immediate hypersensitivity reactions, potentially BUDESITAN Clonmel serious hypokalaemia (monitor K+ levels). Caution: 4MO CF (risk of GI disturbances). Pregnancy (esp. 1st Corticosteroid. Budesonide 0.5mg/2ml, 1mg/2ml. trimester), lactation. White to off-white suspension. 0.5mg/2ml-20, C Caution: b2-agonists, corticosteroids, A25.49; 1mg/2ml-20, A36.78. anticholinergics, xanthine derivatives, MAOIs, TCAs, diuretics, digoxin. Anaesthetics containing S Persistent bronchial asthma in patients
246
halogenated hydrocarbons: Monitor closely or consider discontinuing Combineb prior to surgery. A Accommodation disorders, palpitations, tachycardia, coughing, dysphonia, dryness of mouth, nausea, headache.
COMBIVENT UDV
Boehringer Ing.
9MO Selective b2-agonist/anticholinergic. Salbutamol (as sulph.) 2.5mg, ipratropium bromide 500mcg per 2.5ml single dose unit. Nebuliser soln. 20, A9.26; 60, A27.79. S Bronchospasm in patients with COPD who require regular treatment with both ipratropium bromide and salbutamol. P 1 unit nebulised three or four times daily. Q Under 12 years, not recommended. Over 12 years. as per adults. D Hypertrophic obstructive cardiomyopathy or tachyarrhythmia. Pregancy, lactation (unless benefit outweighs risk). B Caution: Severe vascular or heart disorders, recent MI, diabetes, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy, bladder-neck obstruction, severe airway obstruction. May occur: Immediate hypersensitivity reactions, potentially serious hypokalaemia, ocular complications (when sprayed inadvertently in eye). Advise patient to seek medical advice if dyspnoea worsens. Warn patients with underlying severe heart disease to seek medical advice if symptoms of worsening heart disease occur. C b-blockers, corticosteroids, xanthine derivatives, other b-agonists, anticholinergics, inhalation of halogenated hydrocarbon anaesthetics. A Dry mouth.
DUOVENT
Boehringer Ing.
5MO Selective b2-agonist/anticholinergic. Fenoterol hydrobromide 1.25mg, ipratropium bromide 500mcg per 4ml. Preservative-free soln. in single dose units. 20 x 4ml, A10.79. S Acute asthma or reversible airways disorders. P Over 14 years, 1 vial nebulised immediately. Repeat dose, max.4 vials in 24 hours. B Hyperthyroidism, myocardial insufficiency, angina, cardiac arrhythmias, hypertension. Glaucoma, prostatic hypertrophy. C Sympathomimetics. A Headache, peripheral vasodilatation. Dry mouth.
FLIXOTIDE EVOHALER
A&H
4MO Corticosteroid. Fluticasone propionate 50mcg, 125mcg, 250mcg per dose. CFC-free metered dose inhaler. 50mcg-120-dose unit, A8.19; 125mcg-60dose unit, A12.44; 120-dose unit, A24.86; 250mcg60-dose unit, A21.13; 120-dose unit, A42.26. S Treatment and prevention of bronchial asthma and COPD. P Asthma, 100-1000mcg twice daily. COPD, 500mcg twice daily. Q Asthma, under 4 years, not recommended; over 4 years, 50-100mcg twice daily.
4MO ALSO FLIXOTIDE DISKUS Fluticasone propionate 50mcg, 100mcg, 250mcg, 500mcg per dose. Breath
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 actuated inhaler. 50mcg-60 dose unit, A6.97; 100mcg-60 dose unit, A12.19; 250mcg-60 dose unit, A25.33; 500mcg-60 dose unit, A42.96. S Prophylactic management of asthma and treatment of COPD. P Asthma, 100-1000mcg twice daily. COPD, 500mcg twice daily. Q Asthma, under 4 years, not recommended; over 4 years, 50-100mcg twice daily.
BRONCHODILATORS, OTHER
ANTI-ASTHMATICS
11.1
Q 6-12 years, initially 200mcg twice or 200400mcg once daily; max. 400mcg twice daily. Over 12 years, as per adults. B Not indicated for treatment of acute 9MO Anticholinergic/b2-agonist. Ipratropium bromide (as dyspnoea or status asthmaticus. Severe hepatic monohydrate) 0.5mg and salbutamol (as sulphate) dysfunction. Active and quiescent pulmonary tuberculosis, fungal, viral or other infections of 2.5mg. Nebuliser sln 20, A7.87; 60, A23.62. the airways (concomitant treatment required). S Bronchospasm in patients with COPD Monitor height of children receiving prolonged who require regular treatment with both treatment. Caution when switching from systemic ipratropium bromide and salbutamol. treatment. Should not be stopped abruptly. 4MO P 1 three or four times daily. Pregnancy, lactation (only if benefit outweighs ALSO FLIXOTIDE NEBULES Fluticasone propionate Q Over 12 years, as per adults; under 12 risk). Contains lactose. 0.5mg, 2mg per 2ml. Susp. in single use amps. for years, not recommended. C Ketoconazole (avoid). Caution: Other inhalation by nebulisation. 0.5mg/2ml-10 x 2ml, D Hypertrophic obstructive potent inhibitors of CYP3A4. A9.77; 2mg/2ml-10 x 2ml, A39.07. cardiomyopathy or tachyarrhythmia. Pregnancy, A Oropharyngeal candidiasis, hoarseness, S Prophylactic management in severe lactation (unless benefit outweighs risk). asthma. Treatment of acute exacerbations of B Monitor for signs of acute narrow-angle cough, oral mucosal irritation, swallowing difficulty. asthma. glaucoma. Inadequately controlled diabetes P 500-2000mcg twice daily via a nebuliser. mellitus, recent MI, severe organic heart/vascular NOVOLIZER SALBUTAMOL Meda Q Under 4 years, not recommended; 4-16 disorders, hyperthyroidism, pheochromocytoma, years, 1000mcg twice daily. 9MO prostatic hypertrophy; careful assessment of risk/ B Active or quiescent pulmonary benefit. Hypersensitivity reaction, potentially Selective b2-agonist. Salbutamol 100mcg (as the tuberculosis. Pregnancy, lactation. Transferring serious hypokalaemia may occur. Cystic fibrosis sulphate) per delivered dose. Inhalation powder. from systemic steroids. (risk of GI disturbances). 200-dose unit, A8.24; refill, A5.96. A Hoarseness, candidiasis of mouth and C Caution: Corticosteroids, S Conditions with associated reversible throat. Paradoxical bronchospasm. Rarely rash, anticholinergics, xanthine derivatives, MAOIs, airway obstruction, e.g. asthma or chronic peripheral oedema. TCAs, anaesthetics containing halogenated obstructive pulmonary disease with a substantial hydrocarbons. component of reversibility. Prevention of asthma FORADIL Novartis A Headache, palpitations, tachycardia, dry attacks induced by exercise or exposure to mouth, nausea, coughing, dysphonia, allergens. 5MO accommodation disorders. P Symptomatic treatment, 1 inhalation Selective long-acting b2-agonist. Formoterol (100mcg) as starting dose. If no improvement after fumarate 12mcg. Dry powder capsules; breath IPRAVENT Clonmel 5-10 mins, a 2nd inhalation may be taken. At least actuated inhaler device. 60 with inhaler device, 4 hours should elapse between each dose. A26.09. 2MO S Maintenance treatment of reversible Anticholinergic. Ipratropium bromide 250mcg/1ml. Prevention, 2 inhalations taken 10-15 mins prior to challenge with interval of min. 1 min. Max. 8 obstructive airways disease in asthma, chronic Nebuliser sln. 1ml-20, A4.08; 2ml-20, A4.85. inhalations in 24 hrs. bronchitis and emphysema. Limited use for relief S Reversible bronchospasm associated of breakthrough symptoms. with COPD. With concomitant inhaled b2-agonists, Q 6-12 years: Symptomatic treatment, as P Maintenance: 1-2 inhalation caps. twice for treatment of reversible airways obstruction as per adults. Prevention, one inhalation (100mcg) taken 10-15 mins prior to challenge and a further daily.Relief of breakthrough symptoms: 1-2 extra in acute and chronic asthma. inhalation if necessary. Max. 4 inhalations in 24 inhalation caps. per day on not more than 2 days P 250-500mcg 3 to 4 times daily. Acute hrs. per week. bronchospasm: 500mcg. Repeated doses can be B Should not be only treatment in Q Not recommended admin. until patient stable. Daily doses q 2mg moderate to severe or unstable asthma. Instruct B Ischaemic heart disease, cardiac only under medical supervision. arrythmias, pregnancy, lactation. Q Over 12 years, as per adults. 6-12 years: patient in regular measurement of PEFR. Seek medical advice if asthma control not improved or C b-blockers, sympathomimetics. 250mcg, up to 1mg total daily dose. 0-5 years (acute asthma only): 125-250mcg, up to 1mg total more inhalations are required. Caution: Serious A Tremor, headache, palpitations. cardiac disorders, CHD, hypertrophic obstructive daily dose, with at least 6 hourly intervals cardiomyopathy, tachyarrhythmia, severe and GERIVENT Gerard between doses. untreated hypertension, aneurysm, B Caution: Narrow-angle glaucoma 9MO hyperthyroidism, diabetes, phaeochromocytoma. (protect eyes), prostatic hyperplasia, bladderSelective b-agonist. Salbutamol 100mcg per dose; Risk of potentially serious hypokalaemia; caution outflow obstruction, cystic fibrosis (risk of GI metered-dose aerosol. 200-dose CFC Free, A2.80. disturbances). Immediate hypersensitivity reactions in acute severe asthma. Pregnancy, lactation (only S Treatment and prophylaxis of bronchial if benefit outweighs risk). may occur. Warn patients not to let sln or mist asthma. Treatment of reversible airways C Avoid non-selective b-receptor blocking enter eyes. Pregnancy, lactation. obstruction with chronic bronchitis and drugs. Caution: Xanthine derivatives, C b-adrenergic drugs, xanthine emphysema. glucocorticoids, diuretics, cardiac glycosides; preparations. P Acute attack 1-2 puffs. Prophylaxis 2 A Headache, cough, local irritation, GI monitor serum K+. Halogenated anaesthetics; use puffs, not more than every 4 hrs. Max. 8 puffs in disorders. salbutamol 6 hours before. MAOIs, TCAs. 24 hrs. A Restlessness, fine tremor, dizziness, Q Acute attack and prophylaxis: 1 puff NOVOLIZER BUDESONIDE Meda cough, nausea, taste alteration, sweating, increasing to 2 if necessary. Max. 8 puffs in 24 hrs. headache, appl. site reaction. 4MO D Preterm labour and threatened Corticosteroid. Budesonide 200mcg per dose. abortion. NUELIN SA Meda Inhalation powder. 100-dose unit, A18.52; refill, B Risk of potentially serious 2MO A12.37. hypokalaemia, unwanted stimulation of cardiac 4MO Xanthine. Theophylline 175mg white sust.-release adrenergic receptors. Do not increase dose tab. marked NLS 175 and 3M. 60, A3.66. ALSO NOVOLIZER BUDESONIDE 400 Budesonide without medical advice. Caution: Angina, severe 400mcg per dose. Inhalation powder. 50-dose unit, S Bronchospasm. tachycardia, thyrotoxicosis. Pregnancy, lactation P 1-2 twice daily after food. A18.52. (only if benefit outweighs risk). Q Under 6 years, not recommended; over S Persistent asthma. C Avoid b-blockers. Caution: Xanthine 6 years, 1 twice daily after food. derivatives, steroids, diuretics, long-term laxatives, P Initially, 200-400mcg once daily halogenated anaesthetics, guanethidine, reserpine, (evening) or twice daily. Max. 800mcg twice daily. 2 M O ALSO NUELIN SA-250 Theophylline 250mg white For maintenance titrate to lowest effective dose. methyldopa, MAOIs, TCAs. scored sust.-release tab. marked NLS 250 and 3M. Admin. regularly even when asymptomatic. A Mild tremor, headache, palpitations, tachycardia.
IPRAMOL STERI-NEBS
Teva
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
247
11.1 BRONCHODILATORS,
OTHER ANTI-ASTHMATICS
An Option* for Mild Asthma!
*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.
RESPIRATORY
60, A5.13. P 1-2 twice daily after food. Q Under 6 years, not recommended; over 6 years, half adult dose after food. B Cardiac or liver disease, peptic ulcer, insomnia, hyperthyroidism, severe hypertension, epilepsy. Pregnancy, lactation. C Cimetidine, allopurinol, corticosteroids, frusemide, isoprenaline, oral contraceptives, thiabendazole, ciprofloxacin, erythromycin or other macrolide antibiotics, phenytoin, carbamazepine, barbiturates, lithium, rifampicin, sulpnpyrazone, fluvoxamine, adrenergic agonists, glucagon, xanthines, St John’s wort. A Tachycardia, nausea, GI distress, headache, insomnia, arrhythmias.
serum alpha1-proteinase inhibitor level constantly over 80mg/dl which correlates with pulmonary levels of 1.3mcM. 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 OXIS TURBOHALER AstraZeneca regular repeated receipt of human plasma-derived proteinase inhibitors. Smoking cessation 5MO recommended. Pregnancy (caution), lactation. Selective b2-agonist. Formoterol fumarate 6mcg, Contains Na+. 12mcg per dose. Breath-actuated metered-dose A Fever, flu-like symptoms, dyspnoea, powder inhaler. 6mcg-60 dose unit, A20.11; urticaria, nausea. 12mcg-60 dose unit, A25.24. S Relief of broncho-obstructive symptoms in asthma patients when corticosteroids alone are PULMICORT TURBOHALER AstraZeneca not adequate. Exercise induced asthma. P 6-12mcg once or twice daily in the 4MO morning and/or night; max. 72mcg daily. Corticosteroid. Budesonide 100mcg, 200mcg, Q Over 6 years, 12mcg once or twice daily; 400mcg per dose. Breath-actuated, metered-dose max. 24mcg. dry powder inhalers. 100mcg per dose-200 doses, B Severe cardiovascular disorders, A20.37; 200mcg per dose-100 doses, A20.42; diabetes. Pregnancy, lactation. 400mcg per dose-50 doses, A20.42. C b-blockers, sympathomimetics, S Bronchial asthma in patients who have anaesthetics. not previously been controlled on bronchodilators A Rare tremor, palpitations, headache. and/or anti-allergic agents. COPD. P The dosage should be individualised PHYLLOCONTIN CONTINUS according to asthma severity. Max. 1600mcg daily Mundipharma in divided doses. In less severe cases 200-800mcg daily may be used. COPD: 400mcg twice daily. 2MO Xanthine. Aminophylline 225mg. Pale yellow film- Q 200-800mcg daily in divided doses. During periods of severe asthma, daily dose may ctd sust.-release tab. marked SA one side, Napp be increased to 800mcg. Maintenance dose should logo on reverse. 56, A3.91. S Bronchospasm associated with asthmas, be lowest possible. 4MO emphysema and chronic bronchitis. P Initially 1 12-hourly for one week, then ALSO PULMICORT CFC-FREE INHALER Budesonide maintenance 2 twice daily. 100mcg, 200mcg. Metered dose aerosol. 120 dose. Q Use paed. tabs. 100mcg, A10.68; 200mcg, A16.69. D Hypersensitivity to xanthine group of S Bronchial asthma, not previously well drugs. Pregnancy (only if essential), lactation. controlled on bronchodilators and/or anti-allergic B Cardiac or liver disease, viral infection, agents. elderly; reduce dose. History of seizure (not P 200mcg twice daily morning and advised), insomnia. evening. Severe asthma, up to 1600mcg daily. Well C Cimetidine, erythromycin, controlled patients, daily dose may be reduced sympathomimetics in children. b-adrenergic below 400mcg but not below 200mcg. Not for use agonists, glucagon, ephedrine. in acute attacks. A Nausea, gastric irritation, headache, CNS Q Under 12 years, 100-400mcg twice daily, stimulation. max 800mcg/day. Over 12 years, as per adults.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK.
PROLASTIN
Full prescribing Information is available from: Merck Sharp & Dohme Ireland (Human Health) Limited, Pelham House, South County Business Park, Leopardstown, Dublin 18.
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
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
248
SBL Vaccin AB
2J
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
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
S Regular treatment of asthma where use of a bronchodilator and inhaled corticosteroid together is considered appropriate. COPD in adults. PULMOZYME Genentech/Roche P Asthma in adults and children 12 years and older: 1 puff twice daily. COPD: 1 puff twice 2NT daily (Seretide 500). Recombinant human deoxyribonuclease. Dornase Q 4-12 years, 1 puff twice daily (Seretide alfa 2.5mg/2.5ml. Plastic amp. containing 2500 U (2.5mg) per 2.5ml admin. by compressed air-driven 100); under 4 years, not recommended. 4MO nebuliser. 6, A171.00. ALSO SERETIDE EVOHALER Salmeterol (xinafoate) S Management of cystic fibrosis patients 25mcg, plus fluticasone (propionate). CFC-free with a forced vital capacity (FVC) of greater than MDI. Seretide 50 Evohaler (25mcg salmeterol/ 40% of predicted and to improve pulmonary 50mcg fluticasone) 120 dose unit, A26.96; Seretide function. P 2.5mg once daily by inhalation. Patients 125 Evohaler (25mcg salmeterol/125mcg fluticasone) 120 dose unit, A44.70; Seretide 250 over 21 years may benefit from a twice daily Evohaler (25mcg salmeterol/250mcg fluticasone) dosage. 120 dose unit, A66.71. B Pregnancy, lactation. P Asthma in adults and children 12 years A Pharyngitis, voice changes, chest pain, and older: 2 puffs twice daily. occasionally laryngitis, rashes, urticaria, and Q 4-12 years: 2 puffs of 25/50mcg twice conjunctivitis. daily. Max. fluticasone dose, 100mcg twice daily. QVAR Teva Under 4 years, not recommended. B Acute asthma symptoms - use short 4MO acting b-agonist. Severe cardiovascular disorders, Corticosteroid. Beclomethosone dipropionate diabetes mellitus, untreated hypokalaemia, 50mcg,100mcg/dose. CFC-free metered dose thytoroticosis, pulmonary tuberculosis, transferring aerosol or autohaler. AeroChamber Plus device from systematic steroids. Pregnancy, lactation. compatible with aerosol. 200-dose 50mcg-1, C b-blockers, b-agonists. A10.34; 200-dose 100mcg-1, A22.09. A Candidiasis of the mouth and throat, S Prophylactic anti-inflammatory headache, palpitations, tremor, throat irritation, treatment of reversible obstructive airway disease. hoarseness/dysphonia, muscle cramps. P Starting/maintenance: Mild/moderate asthma, 50-200mcg twice daily; severe, up to SEREVENT A&H 400mcg twice daily. Max. 800mcg daily. 4MO Q Under 5 years, not recommended; 5-11 Selective b2-agonist. Salmeterol (as xinafoate) years, 50mcg twice daily. Reduce to min. 25mcg per dose; metered dose aerosol. 120-dose maintenance control dose. unit, A28.13. B Active or quiescent pulmonary S Long-term regular treatment of tuberculosis. Transferring from systemic steroids. obstructive airways disease, due to asthma (incl. A Hoarseness, candidiasis of mouth and nocturnal and exercise-induced asthma), and throat. COPD. SALAMOL EASI-BREATHE Teva P Asthma, 2 puffs twice daily. Severe cases, up to 4 puffs twice daily. COPD, 2 puffs 9MO twice daily. Selective b2-agonist. Salbutamol 100mcg per dose. Q Not recommended. Breath-actuated inhaler, both CFC and CFC-free. 4MO 200-dose unit, A7.56. ALSO SEREVENT DISKUS Salmeterol (as xinafoate) 9MO 50mcg per dose; breath operated inhaler. 60 dose ALSO SALAMOL CFC-FREE INHALER Salbutamol unit, A27.26. 100mcg per dose. 200-dose, A2.81. P Asthma, 1 blister twice daily. Severe S Treatment and prophylaxis of cases, up to 2 blisters twice daily. COPD, 1 blister bronchospasm, treatment of bronchitis and twice daily. emphysema, relief of acute dyspnoea. Q Not recommended. P Acute attack, 1-2 puffs. Prophylaxis, 2 B Pregnancy, lactation. puffs three or four times daily. C b-blockers. Q Half adult dose. A Rarely tremor, headache, subjective B Hyperthyroidism, serious cardiovascular palpitations. disorders, hypertension, pregnancy, diabetes. See
ANTI-ASTHMATICS
11.1
steroids. A Hoarseness, candidiasis of mouth and throat.
SPC. C Sympathomimetics. b-blockers. A Fine tremor, slight tachycardia, nervous tension, headache, peripheral vasodilation, hypokalaemia, hypersensitivity reactions.
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 asthma inadequately controlled by inhaled 4MO corticosteroids and short-acting b-agonists. Selective long-acting b2-agonist/corticosteroid. Symptomatic relief of concomitant seasonal Salmeterol (xinafoate) 50mcg, and fluticasone (propionate). Breath-actuated inhaler. Seretide 100 allergic rhinitis in adult asthma patients (15 years and older). Exercise induced bronchoconstriction. Diskus (50mcg salmeterol/100mcg fluticasone) 60 2NO dose unit, A32.06; Seretide 250 Diskus (50mcg ALSO SINGULAIR PAEDIATRIC Montelukast (as salmeterol/250mcg fluticasone) 60 dose unit, 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,
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
249
11.1 BRONCHODILATORS, A32.94.
OTHER ANTI-ASTHMATICS
5mg-28, A32.94. S Add-on therapy in mild to moderate asthma inadequately controlled by inhaled corticosteroids and short-acting b-agonists. Alternative to low-dose inhaled corticosteroids in patients (2 years and older) with mild persistent asthma without a recent history of serious asthma attacks that required oral corticosteroid use, and are incapable of using inhaled corticosteroids. Exercise induced bronchoconstriction in patients 2 years and older. P 10mg daily in the evening with or without food. Q Under 2 years, see Singulair Paediatric Granules, below. 2-5 years, 4mg in the evening. 614 years, 5mg in the evening. If with food, take 1 hour before or 2 hours after.
RESPIRATORY
Anticholinergic. Ipratropium bromide 250mcg/ml; preservative free single dose nebuliser soln. in vials. 20 x 1ml, A4.29; 20 x 2ml, A5.10. S Reversible airways obstruction. P 0.4-2ml by nebuliser up to four times daily. Q Under 3 years, not recommended; over 3 years, 0.4-2ml by nebuliser up to three times daily. B Glaucoma, prostatic hypertrophy. A Occasional paradoxical bronchospasm, dry mouth, constipation, urinary retention.
Q Not recommended.
5MO
ALSO SYMBICORT TURBOHALER 100/6 Budesonide 100mcg, formoterol fumarate dihydrate 6mcg per inhalation dose. White inhalation powder. 100/6-120 doses, A45.11. S Regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta-agonist) is appropriate. Not appropriate for severe asthma. P Maintenance, 1-2 inhalations twice daily. Max. 4 inhalations twice daily. Maintenance and reliever therapy, see 200/6. STERI-NEB SALAMOL Teva Q 12-17 years, 1-2 inhalations twice daily. 6 years and older, 2 inhalations twice daily. Under 9MO 6 years, not recommended. Selective b2-agonist. Salbutamol (as sulphate) B Withdraw gradually. Caution patients 2.5mg, 5mg per 2.5ml; preservative-free soln. in 2NO with: Thyrotoxicosis, phaeochromocytoma, single dose units. 2.5mg/2.5ml_20, A3.01; 5mg/ cardiovascular disorders, diabetes, hypokalaemia, ALSO SINGULAIR PAEDIATRIC GRANULES 2.5ml_20, A6.07. risk factors for osteoporosis. Pregnancy and Montelukast (as Na+) 4mg. Granules in sachets. 28, S Management of chronic bronchospasm A32.94. lactation (only if benefit outweighs risk). unresponsive to conventional therapy. Treatment Transferring patients from systemic steroids. Not S As per Singulair Paediatric. of acute severe asthma. for initial management of asthma. Children: Q 6 months-5 years: One sachet daily in V 2.5mg nebulised up to three or four Monitor height regularly. Contains lactose (incl. the evening. Under 6 months, not recommended. times daily. If necessary, increase to 5mg up to small amounts of milk proteins). Admin. directly in mouth, or mixed with spoonful three or four times daily. C Avoid: Itraconazole, ritonavir, other of cold or room temperature soft food. When B Hyperthyroidism. Myocardial potent CYP3A4 inhibitors, b-blockers. Caution: mixed, do not store for future use. Continue insufficiency, angina, cardiac arrhythmias, Quinidine, disopyramide, procainamide, treatment even if asthma is under control. hypertension. Pregnancy. phenothiazines, antihistamines, MAOIs, TCAs, LB Singulair: Do not substitute for inhaled C Sympathomimetics. Dopa, L-thyroxine, oxytocin, alcohol, halogenated or oral steroid therapy. Paediatric Singulair: Do A Fine tremor, headache, peripheral HC, digitalis glycosides. not abruptly substitute for inhaled or oral vasodilation, hypokalaemia. A Headache, palpitations, tremor, corticosteroids. Do not use for relief of acute asthma symptoms. Discontinue if symptoms of STERI-NEB SALINE Teva coughing, hoarseness, candidiasis of mouth and throat. Churg-Strauss syndrome appear. Pregnancy, 2OY lactation (only if essential). Chewable tabs. contain Nebuliser diluent. Sodium Cl 0.9%; preservative UNIPHYLLIN CONTINUS aspartame. 10mg tabs. contain lactose. free soln in single dose unit. 20 x 2.5ml, A3.95. C Caution: CYP3A4 inducers (see Apx I). Mundipharma S Dilution of solutions for nebulisation. A Abdominal pain, headache, thirst. Very 2MO V As required. rarely, suicidal thinking and behaviour (suicidality). Xanthine. Theophylline 200mg white cap. -shaped SYMBICORT TURBOHALER scored sust.-release tab. marked U200; 300mg SPIRIVA Boehringer Ing. AstraZeneca white cap.-shaped scored sust.-release tab. marked 2NO U300; 400mg white cap.-shaped scored sust.5MO Anticholinergic. Tiotropium bromide monohydrate release tab. marked NAPP U400 one side, 22.5mcg (equiv. tiotropium 18mcg) with delivered SYMBICORT TURBOHALER 200/6. Corticosteroid/ UNIPHYLLIN on reverse. 200mg-56, A4.17; 300mgselective long acting b -agonist. Budesonide 2 dose of 10mcg with HandiHaler. Light green hard 56, A6.38; 400mg-56, A8.72. 200mcg, formoterol fumarate dihydrate 6mcg per cap. containing white inhalation powder marked S Asthma, emphysema, chronic bronchitis. with company logo and product code for use with inhalation dose. White inhalation powder. 120 P Asthma: 200mg 12 hourly, in more doses, A46.40. HandiHaler device. 30 + HandiHaler, A42.55; 30 severe cases 300mg or 400mg 12 hourly. S Regular treatment of asthma where use A (refill pack), 40.35. of a combination (inhaled corticosteroid and long Emphysema, chronic bronchitis: less than 70kg, S Maintenance treatment of chronic 200mg 12 hourly for 1 week, then 300mg 12 acting b-agonist) is appropriate. Severe COPD in obstructive pulmonary disease (COPD). hourly. Over 7- kg, 200 or 300mg 12 hourly for 1 adults. P Inhale 1 cap. at the same time once week, then 400mg 12 hourly. P Asthma: Maintenance, 1-2 inhalations daily using the HandiHaler. Q Asthma, under 7 years, not twice daily. Max. 4 inhalations twice daily. When Q Under 18 years, not recommended. recommended; over 7 years, usual maintenance control achieved with twice daily, consider once 2NO 200mg 12 hourly. Chronic asthma may require daily treatment. Maintenance and reliever ALSO SPIRIVA RESPIMAT Tiotropium bromide 300mg 12 hourly. therapy, 2 inhalations daily plus 1 additional monohydrate 3.124mcg equiv. tiotropium 2.5mcg D Hypersensitivity to xanthine group of inhalation as needed in response to symptoms. If per puff. Sln for inhalation. Respimat Soft Mist drugs. Lactation. symptoms persist after a few mins, an additional A Inhaler (60 puffs), 48.79. inhalation should be taken. Max. 6 inhalations on B Cardiac or liver disease. Peptic ulceration, pregnancy, viral disease. P 5mcg given as two puffs at the same any single occasion. Max. daily: 8 inhalations; 12 time once daily using Respimat inhaler. inhalations may be used for a limited period with C Cimetidine, erythromycin, b-adrenergic agonists, glucagon, ephedrine, ciprofloxacin, Q Under 18 years, not recommended. medical advice. COPD: 2 inhalations twice daily. fluvoxamine, interferon, steroids, diuretics. See B Acute episodes of bronchospasm, Q 12-17 year olds: Maintenance, 1-2 SPC. narrow-angle glaucoma, prostatic hyperplasia, inhalations twice daily. Maintenance and reliever A Nausea, gastric irritation, headache, CNS bladder-neck obstruction, moderate to severe therapy: Not indicated. stimulation. renal impairment. Pregnancy, lactation (only if 5MO benefit outweighs risk). Caps. contain lactose. ALSO SYMBICORT TURBOHALER 400/12 VENTAMOL CFC-FREE Pinewood Driving/ using machines (if headache, dizziness or Budesonide 400mcg, formoterol fumarate blurred vision occur). 9MO dihydrate 12mcg per inhalation dose. White C Other anticholinergic drugs. inhalation powder. 60-dose, A46.40. Selective b2-agonist. Salbutamol 100mcg per A Dry mouth. actuation. Aerosol. 200 doses, A3.30. P Asthma: Maintenance, 1 inhalation S Management of asthma symptoms, twice daily. Max. 2 inhalations twice daily. STERI-NEB IPRATROPIUM Teva relief of wheezing and shortness of breath. Maintenance and reliever therapy: Not indicated. 2MO Treatment of reversible airways obstruction. COPD: 1 inhalation twice daily.
250
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
PREPARATIONS
11.2
P 1-2mg twice daily with food. Q Under 2 years, not recommended; over 2 years, 1mg twice daily with food. D Pregnancy, lactation. B Withdraw over 2-4 weeks. Intercurrent 9MO ALSO VENTOLIN DISKUS Salbutamol 200mcg/dose. infections should be treated with specific antimicrobial therapy. Reactions may be impaired. Breath actuated inhaler. 60 dose unit, A6.16. C Alcohol, CNS depressants, oral V Acute attacks, 200mcg as required. Chronic maintenance or prophylaxis, 200mcg up to hypoglycaemics, antihistamines. four times daily. Prevent exercise-induced asthma, A Drowsiness, impaired reactions, dry mouth, dizziness. Occasionally CNS stimulation, 200mcg before challenge. weight gain. B Hyperthyroidism, serious cardiovascular disorders, hypertension, diabetes. Pregnancy. See ZEPHOLIN SR Astellas SPC. C Sympathomimetics, b-blockers, MAOIs, 2MO anaesthetics. Xanthine. Theophylline 100mg, 200mg, 350mg. A Fine tremor, slight tachycardia, nervous Prolonged release caps. marked TH100, TH 200 VENTOLIN EVOHALER A & H tension, headache, peripheral vasodilation, and TH 350, resp. 100mg, blue/white; others, hypokalaemia, hypersensitivity reactions. Cardiac 9MO green. 100mg-56, A2.15; 200mg-56, A4.25; arrhythmias (incl. atria fibrillation, supraventricular 350mg-56, A7.73. Selective b2-agonist. Salbutamol 100mcg/dose. CFCtachycardia and extrasystoles) may occur, usually S Symptomatic or prophylactic relief of free metered dose aerosol. 200-dose unit, A3.03. in susceptible patients. bronchospasm associated with asthma, chronic S Prophylaxis and treatment of airways bronchitis and emphysema. obstruction due to bronchial asthma and chronic VOLUMATIC A & H P Usually 400-1000mg daily in two divided obstructive airways disease. doses adjusting according to response. P Acute attack: 1-2 puffs; chronic therapy: O Q Under 10kg body weight, not 2 puffs up to four times daily; prevention of Two-piece 750ml large volume reservoir chamber recognised allergen or exercise induced device to take aerosol with actuator i.e. Becotide, recommended; 10-20kg, 100mg twice daily; 2040kg, 200mg twice daily. bronchospasm: 2 puffs. Flixotide, Serevent, Seretide or Ventolin inhalers. D Hypersensitivity to xanthine group of Q Half adult dose, up to adult dose if 1, A3.09. drugs. Pregnancy, lactation. required. 5MO XOLAIR Novartis B Cardiac or liver disease, peptic ulceration, insomnia. ALSO VENTOLIN TABLETS Salbutamol (sulph.) 2M 2mg, 4mg. White round tabs. marked with a score Monoclonal antibody. Omalizumab150mg. Powder C Cimetidine, erythromycin, ciprofloxacin, allopurinol, oral contraceptives, b-adrenergic line and GX CN3 or GX CN5 resp. on one side. and solvent for soln. for inj. 1, A444.93. agonists, glucagon. 2mg-100, A1.36; 4mg-100, A2.61. S Add-on therapy in patients with severe A GI disturbances (nausea, vomiting, 5MO persistent allergic asthma despite daily high-dose ALSO VENTOLIN SYRUP Salbutamol (sulph.) 2mg/ inhaled corticosteroids, plus a long-acting inhaled anorexia). CNS stimulation, insomnia. Cramps, convulsions, supraventricular tachycardia, 5ml. Sugar-, colouring-free. 150ml, 85c. b2-agonist (and with convincing IgE mediated arrhythmias. P 4-8mg three or four times daily. asthma). Q Under 2 years, not recommended. 2-6 P 75-375mg in 1 to 3 sc inj., depending on 11.2 COUGH PREPARATIONS years: 3-8mg in three or four divided doses. 6-12 baseline IgE and body weight, see SPC for detailed years: 6-8mg in divided doses. Over 12 years: 6dosage. Max. 375mg every 2 weeks. Assess at 16 ACTIFED TABLETS McNeil Healthcare 16mg in divided doses. weeks, continue if marked improvement in overall 0 K 5NO asthma control. Use initial dose determination Antihistamine/sympathomimetic. Triprolidine (HCl) ALSO VENTOLIN CONCENTRATE SOLUTION FOR IV following dose interruptions Q 1 year. 2.5mg, pseudoephedrine (HCl) 60mg. White scored INFUSION Salbutamol (sulph.) 1mg/ml. Amp. for R Over 65 years, limited data. tab. marked WELLCOME M2A. 12, A3.67. IV inf. 5ml, A35.77. Q Under 12 years, not recommended. S Upper respiratory tract disorders such as S Severe bronchospasm and status B Not indicated for acute asthma allergic rhinitis, vasomoter rhinitis and common asthmaticus. Management of uncomplicated exacerbations, acute bronchospasm or status cold. premature labour in last trimester. asthmaticus. Hyperimmunoglobulin E syndrome, P 1 every 4-6 hours, up to four times a P Bronchospasm and status asthmaticus: 3- allergic bronchopulmonary aspergillosis and day. 20mcg/min (start with 5mcg/min) by IV slow inj. prevention of anaphylactic reactions; no data. Q Under 12 years, not recommended. using a 10mcg/ml dose (5ml of sln + 500ml of an Caution: Autoimmune diseases, immune complex0K inf. sln), adjust according to response. For mediated conditions, renal/hepatic impairment, ALSO ACTIFED SYRUP 10ml equiv. to 1 tab. premature labour: 10mcg/min by IV inf. Increase transferring from systemic or inhaled 100ml, A3.99. rate until evidence of response; usual range: 10-45 corticosteroids, patients at high risk of helminth S Upper respiratory tract conditions such mcg/min. Once uterine contractions have ceased infection, diabetics. Contains sucrose. Local or as common cold, hay fever, allergic and vasomaintain inf. rate at same level for 1 hour and systemic allergic reactions may occur. Rarely motor rhinitis and aerotitis. then reduce by 50% decrements at 6-hourly antibodies to omalizumab may develop. intervals. Treatment may be continued orally. A Headache, inj. site reactions, erythema, P 10ml every 4-6 hours, up to four times a day. Q Not recommended. pruritus, swelling. Q Under 2 years, not recommended. 2-5 5NO ZADITEN Novartis years, 2.5ml. 6-12 years, 5ml. Both every 4-6 hours, ALSO VENTOLIN INJECTION Salbutamol (sulph.) up to four times a day. 5mcg/ml. Sln for inj. 10 x 5ml, A2.47. 2MO D Severe hypertension or severe coronary P Bronchospasm and status asthmaticus: Antihistamine/mast cell stabiliser. Ketotifen artery disease. 8mcg/kg SC or IM four hourly, or 4mcg/kg by slow (hydrogen fumarate) 1mg. White scored tab. B Severe hepatic impairment or moderate IV inj. repeated if necessary. For premature labour: coded ZADITEN 1. 60, A9.92. to severe renal impairment. Caution as with other 100-250mcg by IV or IM single inj. 2MO sympathomimetics. Epileptic patients. Risk of Q Not recommended. ALSO ZADITEN CAPS Ketotifen (hydrogen drowsiness and mental alertness impairment. 9MO fumarate) 1mg. White cap marked CS. 56, A10.89. Pregnancy, lactation. ALSO VENTOLIN RESPIRATOR SOLUTION 2MO C MAOIs, furazolidone, other Salbutamol (sulph.) 5mg/ml. Bottle. 20ml, A3.14. ALSO ZADITEN ORAL SOLN. Ketotifen (hydrogen sympathomimetics. Caution: Alcohol or other CNS 9MO fumarate) 1mg/5ml. 300ml, A10.88. depressants, antihypertensive agents, anticholinergics and TCAs. S Prophylaxis of bronchial asthma. ALSO VENTOLIN NEBULES Salbutamol (sulph.)
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.
5mg/2.5ml. Preservative-free soln. in single dose unit. 2.5mg-20, A2.81; 5mg-20, A8.23. V 2.5-5mg up to four times daily via nebuliser.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
251
11.2 COUGH
RESPIRATORY
PREPARATIONS
(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. ADVIL COLD & FLU Wyeth Healthcare Q Under 6 years, not recommended; 6-12 years, 5ml three or four times daily. 0K 2 NSAID/sympathomimetic. Ibuprofen 200mg, pseudoephedrine (HCl) 30mg. Brown oval sug-ctd ALSO BENYLIN DRY NON DROWSY Dextromethorphan 7.5mg/5ml. Syrup. 125ml, A tab. marked with tab. name. 20, 4.13. A3.93. S Relief of common cold and flu S Dry, non productive cough. symptoms incl. blocked sinuses. P 1-2 every four to six hours. Max. 6 in 24 P 10ml three or four times daily. Q Under 6 year, not recommended; 6-12 hours. years, 5ml three or four times daily. Q Under 12 years, not recommended. 2 D Aspirin/NSAID induced allergies. Active ALSO BENYLIN WITH CODEINE Diphenhydramine peptic ulcer, diabetes or thyroid disease. Heart (HCl) 14mg, codeine phos. 5.7mg, menthol 1.1mg/ disease, circulatory problems, hypertension or 5ml. Syrup. 125ml, A4.65. coronary artery disease. Pregnancy, lactation. S Dry, irritating cough. B Renal, cardiac or hepatic impairment. Elderly. Asthma, prostatic hypertrophy. Caution as P 10ml three or four times daily. Q Under 6 year, not recommended; 6-12 with other NSAIDs. years, 5ml three or four times daily. C MAOIs, TCAs, painkillers or 2 decongestants, warfarin, heparin, other sympathomimetics, furazoline. Caution: ALSO BENYLIN CHILDREN’S CHESTY Guaifenesin Guanethidine, reserpine, methyldopa, 50mg/5ml. Syrup. 125ml, A3.19. guanethidine, digitalis, quinidine and as with S Productive cough. other NSAIDS. Q Under 2 years, not recommended; 2-5 A Dyspepsia, GI bleeding, rash. Anxiety, years, 5ml four times daily; 6-12 years, 10ml four tremor, tachycardia, arrythmias, dry mouth, CNS times daily. stimulation. 2 BENYLIN CHILDREN’S DRY COUGH BENYLIN CHESTY COUGH NON ALSO Diphenhydramine (HCl) 7mg, menthol 0.55mg/ DROWSY McNeil Healthcare 5ml. Syrup. 125ml, A3.29. S Non-productive cough. Relief of allergic 2 conditions or reactions. Expectorant/demulcents. Guaiphenesin 100mg, Q Under 2 year, not recommended; 2-5 menthol 1.1mg/5ml. Syrup. 125ml, A3.69; 300ml, years, 5ml; over 6 years, 10ml. Both three or four A5.75. times daily. P 10ml four times daily. 2 Q Under 6 years, not recommended; 6-12 years, 5ml four times daily. ALSO BENYLIN CHILDREN’S COUGH & COLD 2 Dextromethorphan (hydrobromide) 5mg, triprolidine (HCl) 0.625mg per 5ml. Syrup. 125ml, ALSO BENYLIN COUGH TRADITIONAL A3.29. Diphenhydramine (HCl) 14mg, menthol 1.1mg/ S Dry unproductive cough and 5ml. Syrup. 125ml, A3.93. rhinorrhoea associated with common cold and S Cough, bronchial congestion. influenza. P 5-10ml three or four times daily. Q Under 6 years, not recommended; 6-12 Q Under 2 years, not recommended; 2-5 years, 5ml three or four times daily. years, 5ml three or four times daily; 6-12 years, 2 10ml three or four times daily. 0 ALSO BENYLIN DRY COUGH Diphenhydramine A Insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions (CNS stimulant, particularly in children).
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.
252
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 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
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
RESPIRATORY
COUGH
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.
tranquillisers, alcohol, MAOI’s, TCAs. A Drowsiness, dizziness, ataxia, paraesthesia, headache, restlessness.
ERDOTIN
2O
PREPARATIONS
11.2
blocked nose and sinuses. V Under 12 years: contra. Over 12 years: Initially 2, then 1-2 every four hours. Max. 6 in twenty-four hours. KARVOL Reckitt Benckiser D Stomach ulcer (or history of), other GI disorders. History of asthma, rhinitis, urticaria 2 associated with aspirin or other NSAIDs. Volatile oils. Levomenthol 36.55mg, chlorbutol 2.25mg, thymol 3.15mg, terpineol 66.6mg, pumilio Cardiovascular disease, hypertension, diabetes, pine oil 103.05mg, pine oil sylvestris 9mg. Inhalent phaeochromocytoma, closed angle glaucoma, prostatic enlargement. soln. in cap. 12, A2.22. B Asthma, renal, cardiac or hepatic S Congestion of respiratory tract. DELSYM Bayer HealthCare V Under 3 months not recommended; impairment. Elderly. Pregnancy, lactation. 2 over 3 months, express contents into hot water or C Contra: MAOIs (or within 14 days), sympathomimetics, TCAs. Not recommended: handkerchief and inhale vapour. Avoid contact Antitussive. Dextromethorphan (resin complex Warfarin, heparin, guanethidine, reserpine, with the skin. equiv. dextromethorphan hydrobromide) 30mg/ methyldopa, quinidine. Caution: Zidovudine, anti5ml. Susp. 89ml, A6.46. MUCODYNE sanofi-aventis hypertensives, diuretics, cardiac glycosides, lithium, S Cough. methotrexate, cyclosporin, NSAIDs, corticosteroids, P 5ml, twelve hourly, max. 15ml in twenty 2 O aminoglycosides, probenocid, oral hypoglycaemics. four hours. Mucolytic. Carbocisteine 250mg/5ml; syrup. 100ml, A GI disorders, headache, dizziness, muscle Q 6-12 years, 5ml twelve hourly, max. A1.39; 250ml A3.48; 300ml, A3.40. weakness, palpitations, tremors, acute renal 10ml daily. 2-5 years, 2.5ml twelve hourly, max. S Excessive or viscous mucus, glue ear in failure, liver disorders, haematopoietic disorders. 5ml daily; under 2 years, not recommended. children. Exacerbation of bronchospasm. Restlessness, B Persistent or chronic cough. Excessive P 750mg three times daily reducing to insomnia, hearing disturbance, anxiety, secretions. Pregnancy. 500mg three times daily. hallucinations, chest pain, thirst. A Drowsiness may occur. Q Use paed. syrup. 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 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
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. B History of peptic ulcer. Pregnancy. A GI distress. Nausea. Rash.
NON-DROWSY SINUTAB McNeil Healthcare
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 ILVICO Seven Seas disease, hyperthyroidism, raised intraocular pressure, enlarged prostate. Severe hepatic 2 impairment, moderate/severe renal impairment. Analgesic/antihistamine. Paracetemol 250mg, Ca++ Pregnancy (if benefit outweighs risk), lactation (no ascorbate 36mg, caffeine monohydrate 10mg, data). brompheniramine maleate 3mg. White, round, C TCADs, sympathomimetics, MAOIs, biconvex sugar-ctd tab. 20, A4.17. furazolidone. Hypotensives which interfere with S Common cold, influenza and upper RTIs. sympathetic activity (bretylium, bethanidine, V Over 12 years: 1 or 2 tab. with water 3 guanethidine, debrisoquine, methyldopa, alphatimes daily. and beta-adrenergic blocking agents. W 6-12 years and elderly: 1 tab. two or A CNS excitation. four times daily with water. D Narrow angle glaucoma, NUROFEN COLD & FLU tachyarrhythmias, G6PD deficiency. Pregnancy, Reckitt Benckiser 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). C Hypnotics, antiepileptics, propantheline, 12, A3.46; 24, A5.85. metoclopramide, chloramphenicol, warfarin, S Symptoms of cold and influenza incl. coumarin, AZT, salycamide, analgesics, aches and pains, headache, fever, sore throat,
2O
Mucolytic. Carbocisteine 250mg/5ml. Orange flavoured, sugar-free linctus. 100ml, A1.25; 300ml, A3.12; 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.
PARACODIN
Teofarma
2N 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 yrs) 2.5-5ml. All up to three times daily.
2NO ALSO PARACODIN TABLETS Dihydrocodeine hydrogen tartrate 10mg. White tab. marked with star. 20, A2.90. 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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
253
11.3 RESPIRATORY 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.
0K 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 daily.
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
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.
254
RESPIRATORY
STIMULANTS corticosteroids. P See SPC.
SUDAFED NASAL SPRAY
McNeil Healthcare B Stabilise babyâ&#x20AC;&#x2122;s general condition.
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.
Correction of acidosis, hypotension, anaemia, hypoglycaemia and hypothermia is recommended.
12.1 NASAL PREPARATIONS
AVAMYS
GSK
2NO
Corticosteroid. Fluticasone fuorate, 27.5mcg/spray. Nasal spray, suspension. 1 pack (120 sprays), A11.38. S Allergic rhinitis symptoms. P 12 years and over: Initially, 2 sprays in each nostril once daily (total daily dose, 110mcg); once control achieved, reduce to 1 spray in each TIXYLIX CHESTY COUGH 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. VISCLAIR Sinclair Pregnancy, lactation (only if benefits outweigh risks). 2OY C Not recommended: Ritonavir. Caution: Mucolytic. Methyl cysteine (HCl) 100mg. yellow Potent CYP3A4 inhibitors. sug-ctd tab. 100, A18.33. A Epistaxis (adults and adolescents, more S Chronic bronchitis, viscid or excessive frequent in longer-term use), nasal ulceration. mucus. P 2 three or four times daily for 6 weeks BACTROBAN NASAL GSK then 2 twice daily. 2NO Q Under 5 years, not recommended; over Topical broad spectrum antibiotic. Mupirocin 2%. 5 years, 1 three times daily. Nasal oint. 3g, A6.11. B Pregnancy. S Nasal carriage of staphylococci, incl. A GI distress. methicillin resistant S. aureus. VISCOLEX SYRUP Pinewood V Apply to the anterior nares two or three times daily for 5-7 days. 2O D Pregnancy. Mucolytic. Carbocisteine 250mg/5ml syrup. 100ml, A3.35; 250ml, A3.48. BECONASE A&H S Lower respiratory tract disorders 2KO characterised by excessive viscous mucus. P Initially 15ml three times daily, reducing AQUEOUS NASAL SPRAY. Corticosteroid. 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, A3.87. 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 ALSO CUROSURF Poractant alfa 80mg/ml; susp. in History of, or existent tuberculosis. Patients with immunosuppression. Long-term use. Pregnancy, single-dose vials. 120mg/1.5ml, A530.00; 240mg/ lactation. 3ml, A1060.00. S Treatment of respiratory distress syndrome (RDS) in newborn premature infants with a birthweight of 700g or greater. Prophylaxis in premature infants between 24 and 31 weeks gestational age at risk from RDS or with evidence of surfactant deficiency, where the mother has not received appropriate ante-natal
BETNESOL
UCB
2MO Corticosteroid. Betamethasone Na+ phos. 0.1%. Drops. 10ml, A1.53. S Non-infected inflammatory nasal conditions.
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
OTOLARYNGOLOGY
NASAL
PREPARATIONS
12.1
transferring patients from systemic steroids, untreated nasal infection. A Epistaxis, nasal irritation, dry mucous membranes, naso-sinus congestion, sneezing.
dose). Maintenance, 1 spray per nostril once a day. Max. relief may only be obtained after 3-4 days. Q 4-11 years: 1 spray into each nostril once a day (100mcg), preferably in the morning. In some cases, 1 spray into each nostril twice a day NASEPTIN NASAL CREAM Alliance (max. daily dose). Under 4 years, not recommended. 2NO B Impaired adrenal function (caution Antibacterial. Chlorhexidine (DiHCl) 0.1%, when transferring patients from systemic steroid A neomycin (sulph.) 0.5%. Cream. 15g, 2.44. S Staphylococcal infections and carriage in treatment). Monitor height of children. Pregnancy, lactation (if benefit outweighs risk). the nose. C Avoid potent CYP3A4 inhibitors (eg. V Apply small amount to inside of each ketoconazole, ritonavir). nostril. Prophylaxis, twice daily; eradication, four A Epistaxis, headache, unpleasant taste or times daily for 10 days. smell, nasal and throat dryness/ irritation. B Prolonged use can lead to ototoxicity and nephrotoxicity. NASONEX Schering-Plough C Soap and anionic agents. FLIXONASE A&H 2NO 2MO NASOBEC Teva Corticosteroid. Mometasone furoate 50mcg per dose; metered-dose pump nasal spray. 140-dose Corticosteroid. Fluticasone propionate 0.05% 2MO A unit, A14.65. metered dose nasal spray. 120-dose unit, 8.74. Corticosteroid. Beclomethasone dipropionate S Treatment and prophylaxis of seasonal S Prophylaxis and treatment of seasonal A3.48. 50mcg per dose; aqueous spray. 200-dose, allergic rhinitis, treatment of perennial rhinitis. allergic rhinitis and perennial rhinitis. Nasal polyps in adults (18 years and older). P 2 sprays in each nostril once daily in the S Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. P Allergic rhinitis: 2 sprays in each nostril morning; max. 4 sprays in each nostril daily. P 2 sprays twice daily into each nostril or once daily. If necessary increase to 4 sprays in each Q Under 4 years, not recommended; 4-11 1 single spray into eash nostril three or four times nostril once daily. Reduce to 1 spray in each nostril years, 1 spray in each nostril daily; max. 2 sprays in daily; max. 8 sprays in 24 hours. once daily when controlled. Prophylaxis, start each nostril daily. Q Under 6 years, not recommended; over treatment 2-4 weeks before pollen season. Nasal B Pregnancy, lactation. Caution when 6 years, same as adult. polyposis: Initially 2 sprays in each nostril once transferring patients from systemic steroids. daily. If not controlled after 5-6 weeks, increase to A Irritation of the nasal mucosa, epistaxis, B Caution when transferring from systemic steroids. Pregnancy, lactation. 2 sprays in each nostril twice daily; reduce once taste and smell disturbances. A Nasal and throat irritation, taste and controlled. If no improvement after 5-6 weeks of NASACORT sanofi-aventis smell distrurbances. twice daily dose, consider alternative. Q Under 6 years, not recommended; 6-11 2NO NASOFAN AQUEOUS Teva years, one spray in each nostril once daily. Corticosteroid. Triamcinolone acetonide 55mcg per D Untreated nasal infections, nasal surgery 2MO dose. Unscented nasal spray, susp. 120-dose unit, A11.65. Glucocorticosteroid. Fluticasone propionate 50mcg or trauma. B Tuberculous infections of the respiratory S Seasonal and perennial allergic rhinitis. per 100mcL metered spray. Nasal spray. 120 dose tract, untreated infections or ocular herpes unit, A7.43. P Initially 2 sprays per nostril once daily. simplex. Caution when transferring from systemic S Prophylaxis and treatment of seasonal Maintenance, 1 spray per nostril once daily. steroids. Monitor height of children receiving allergic rhinitis (incl. hay fever) and perennial Q Under 6 years, not recommended; 6-12 prolonged treatment. Pregnancy, lactation. rhinitis. years, 1 spray per nostril once daily. Severe A Headache, pharyngitis, epistaxis, nasal P 2 sprays into each nostril once a day symptoms 2 sprays per nostril once daily. Not (200mcg) preferably in the morning. In some cases, irritation/ ulceration. recommended for long term use in children. B Pregnancy, lactation. Caution when 2 sprays into each nostril twice a day (max. daily
2NO
ALSO BETNESOL-N NOSE DROPS Betamethasone Na+ phos. 0.1%, neomycin sulph. 0.5%. Drops. 10ml, A1.56. S Inflammatory conditions where infection is present or suspected. V 2-3 drops in each nostril two or three times daily. D Viral, fungal or tuberculous conditions. B Prolonged use. Pregnancy, lactation. A Nasal irritation, dryness, sneezing, headache, lightheadedness, urticaria, nausea, epistaxis, rebound congestion, bronchial asthma, perforation of the nasal septum. Sensitisation, cross resistance to neomycin; avoid unnecessary use.
OTRIVINE
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.
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
255
12.2 OROPHARYNGEAL
OTOLARYNGOLOGY
PREPARATIONS
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 BONJELA Reckitt Benckiser handicapped patients). Also for use in a postperiodontal surgery or treatment regimen to 2K Analgesic. Choline salicylate 8.7%, cetalkonium Cl promote gingival healing. Useful in the RHINOCORT TURBOHALER management of aphthous ulceration and oral 0.01%, ethanol (96%) 33.45%, menthol 0.057%, candidal infections (e.g. denture stomatitis and AstraZeneca glycerin 4.6%; gel. 15g, A3.00. S Infant teething, mouth ulcers and sores, thrush). 2MO Q Under 12 years, only use if cold sores, denture irritation. Corticosteroid. Budesonide metered dose dry recommended by a healthcare professional. P Massage approx. half inch of gel not powder inhaler; 100mcg per dose. 200 dose, V Rinse with 10ml for 1 min. twice daily. more than once every three hours. A20.37. 2 S Seasonal and perennial allergic rhinitis, Q Under 4 months, not recommended; ALSO CORSODYL GEL Chlorhexidine gluconate over 4 months, massage approx. quarter inch not vasomotor rhinitis and nasal polyps. more than once every three hours; max. 6 doses in 1%; gel. 50g, A1.93. P Rhinitis: 2 applications in each nostril S Inhibition of the formation of dental twenty four hours. once daily in the morning.Nasal polyps: 1 plaque. Adjunct in treatment and prevention of application in each nostril morning and evening. BYFLUC Ergha gingivitis. Adjunct in maintaining oral hygiene. For Q Not recommended. use in a post-periodontal surgery or treatment 2MO B Pregnancy. Fungal, viral or tuberculous infections. Triazole. Fluconazole 50mg, 150mg. Opaque caps; regimen to promote gingival healing. Useful in the management of recurrent aphthous ulceration A Sneezing, nasal dryness, slight 50mg, light blue cap/ white body;150mg, light and recurrent oral candidal infections. As part of a haemorrhagic secretion. blue cap and body. 50mg-7, A12.56; 150mg-1, preventative programme to help reduce caries A5.31. activity. RHINOLAST Meda S Oropharyngeal candidiasis, chronic oral Q Under 12 years, only use if atrophic candidiasis (denture sore mouth). 2MO 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 Renal impairment: See section 8.2. A13.57. 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. soreness, swelling or mouth irritation occur, stop Q Under 5 years, not recommended; over B Discontinue if symptoms of liver disease 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, DAKTARIN McNeil Healthcare metered dose; (CFC-free) pump spray. 15ml (180astemizole or other P450 substrates, zidovudine, doses) unit and nasal applicator, A4.91. 2MO tacrolimus, rifabutin, benzodiazepines. S Symptomatic relief of rhinorrhoea and Imidazole anti-fungal. Miconazole 20mg per g; A Headache, rash, GI disorders. Hepatic non-allergic rhinitis. oral gel. 40g, A2.91. toxicity incl. rare cases of fatalities, elevated P 2 sprays in each nostril two or three S Fungal infections of oropharynx. alkaline phosphatase, bilirubin, SGOTand SGPT. 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. S Lip sores and mouth ulcers. Herpes C Caution: Other anticholinergics. simplex infections. A Nasal drying, epistaxis, blurring of DEQUACAINE Reckitt Benckiser P Apply thickly to lesions four times daily, vision, headache, nausea, local irritation. 2 preferably after meals and at bedtime. Pharyngitis, sinusitis. Q Under 3 years, not recommended; over Local anaesthetic/anti-bacterial. Benzocaine 10mg, dequalinium Cl 0.25mg. lozenge. 24, A2.73. VIVIDRIN Dr. Mann 3 years, same as adults. 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. Corticosteroid. Hydrocortisone (as Na+ succinate) S Allergic rhinitis (perennial), seasonal DIFFLAM ORAL RINSE Meda 2.5mg pellet marked CORLAN and EVANS. 20, allergic rhinitis, hay fever. 2 V Prophylactic and therapeutic, one spray A1.62. Analgesic, anti-inflammatory. Benzydamine (HCl) S Aphthous ulceration. into each nostril four times daily. V 1 dissolved in the mouth, in contact 0.15%. Soln. 300ml, A5.56. A Transient nasal irritation. 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.
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.
CORSODYL
2K Local anaesthetic/antiseptic. Lidocaine (HCl) 0.9%, chlorocresol 0.1%, cetylpyridinium Cl 0.02%,
256
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.
GSK 2 Y
2 Antibacterial. Chlorhexidine gluconate 0.2%.
ALSO DIFFLAM SPRAY Benzydamine (HCl) 0.15%. Soln. in metered dose pump. 30ml, A4.47.
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
OROPHARYNGEAL PREPARATIONS 12.2
if required. Atrophic candidiasis, 50mg daily for 14 days. Treatment may exceed 14 days in the immunocompromised. Q Neonates, 3mg/kg every 72 hours, aged 2-4 weeks, 3mg/kg every 48 hours; over 4 weeks, 3mg/kg daily. D Pregnancy. B Impairment in hepatic or renal function, DIFLAZOLE Pinewood lactation. C Cisapride, terfenadine, anticoagulants, 2MO oral hypoglycaemics, phenytoin, rifampicin, Triazole. Fluconazole 50mg, 150mg, 200mg. benzodiazepines, cyclosporin, theophylline, Green-white, yellow and white capsules resp. tacrolimus, rifabutin. 50mg-7, A12.85; 150mg-1, A5.50; 200mg-7, A GI disorder, headache, anaphylaxis, rash, A51.60. S Oropharyngeal candidiasis, chronic oral dizziness, seizures, alopecia, exfoliative skin disorders, dyspepsia, vomiting, hepatitis, atrophic candidiasis (denture sore mouth). P 50mg once daily for 7-14 days; max. 14 leucopenia, neutropenia, agranulocytosis, thrombocytopenia, angioedema, face oedema, days except in severely immunocompromised. Associated with dentures, 50mg once daily for 14 pruritus, urticaria. days admin. concurrently with local antiseptic. FLAGYL sanofi-aventis Renal impairment: See section 8.2. 2MO Q Over 4 weeks: 3mg/kg daily; 6mg/kg may be used on day 1. Neonates: 1st two weeks Nitromidazole. Antibacterial. Metronidazole of life, 3mg/kg daily but given every 72 hrs; 200mg, 400mg. Off-white film-ctd tab. and offmax.12mg/kg every 72 hrs. 3rd and 4th weeks of white cap. shaped film-coated tab. Both marked life, same dose but given every 48 hrs; max. 12mg/ with name and strength. 200mg-21, A1.66; 250, A19.65; 400mg-14, A2.35; 100, A16.75. kg every 48 hrs. D Pregnancy, lactation. 2MO B Discontinue if liver disease, rash ALSO FLAGYL-S ORAL SUSPENSION (superficial infection) or bullous lesions/erythema Metronidazole benzoate 200mg/5ml. Susp. 100ml, multiforme (systemic infection) occur. Exfolliative A6.17. cutaneous reactions, toxic epidermal necrolysis S Acute ulcerative gingivitis. Acute dental (AIDS patients). infections. C Terfenadine or cisapride P Gingivitis: 600mg daily in divided doses (contraindicated). Caution: Anticoagulants, for 3 days. Dental infections: 600-800mg daily in benzodiazepines, sulphonylureas, HCTZ, divided doses for 3-7 days. phenytoin, rifampicin, ciclosporin, theophylline, Q Gingivitis: Over 10 years, as per adult. 7zidovudine, rifabutin, tacrolimus, other substrates 10 years, 300mg daily in 3 divided doses. 3-7 years, of cyt P450. 200mg daily in 2 divided doses. 1-3 years, 150mg A Headache, rash, GI disorders. in 3 divided doses. All for 3 days. D Active or chronic severe Peripheral and DIFLUCAN Pfizer Central Nervous System diseases. 2MO B Peripheral or central neuropathy. Leucopenia. Transient epileptiform seizures. Antifungal. Fluconazole 50mg. Blue/white cap. coded FLU 50 and PFIZER. 7 (Cal/Pk), A12.91. Monitor during prolonged use. Hepatic 2MO insufficiency or encephalopathy. Alcohol. Removed during haemodialysis. Fructose intolerance. Elderly. ALSO DIFLUCAN ORAL SUSP. Fluconazole 50mg, 200mg/5ml. White powder which yields an orange Darkens urine. Pregnancy, lactation. C Phenytoin, phenobarbital, flavoured susp. 50mg/5ml-35ml, A19.85; 200mg/ anticoagulants, disulfiram, lithium, cyclosporin, 55ml-35ml, A79.40. fluorouracil, busulfan. S Oropharyngeal candidiasis incl. that A GI distress, furred tongue, unpleasant occurring in immunocompromised patients. Atrophic oral candidiasis associated with dentures. taste. Rash, urticaria, flushing, angioedema, CNS P 50mg once daily for 7-14 days or longer disturbances, headache, dizziness, confusion, 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.
PRESCRIBING NOTES OROPHARYNGEAL PREPARATIONS Povidone iodine preparations used to treat mucosal infections, should not be used over prolonged periods due to possible systemic absorption of iodine. Antiseptic solutions including chlorhexidine, hexetidine are useful in gingivitis and other oral infections. Systemic administration of metronidazole is also indictated for acute ulcerative gingivitis. Treatment of ulceration and inflammation can include the use of gargles and mouthwashes. Other treatments include the use of a mechanical protectants such as carmellose and carbenoloxone, which provide a physical barrier over the ulcer to relieve discomfort but can be difficult to apply. Corticosteroids (triamcinolone, hydrocortisone) are an effective treatment of some forms of ulceration; systemic administration reserved for severe conditions. Local analgesics (lidocaine, choline salicylate) have a more limited role in ulcer treatment but can provide some local pain relief; choline salicylate can cause irritation and salicylate poisoning if used excessively. Lozenges containing antiseptics and analgesics are available to treat sore throats and mouths are of dubious clinical benefit but may provide symptomatic relief for patients. Preparations for the treatment of dry mouth and pharynx are based on carmellose salts or similar compounds and resemble artificial saliva. Antifungals (nystatin, amphotericin, 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.
hallucinations, vision and blood disorders.
FLUCOL
Rowex
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 Recurrent oropharyngeal candidiasis, 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.
2MO 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). 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.
LOCABIOTAL
Servier
2NO Anti-inflammatory/antibiotic. Fusafungine 500mcg per dose in metered dose pump. 50-dose unit, plus nasal and oral adaptors, A1.88. S Upper respiratory tract infection and inflammation. P 1 spray orally and/or in each nostril four hourly. Q Under 30 months, not recommended; over 30 months, 1 spray orally and/or in each nostril 6 hourly. B Pump should be primed before the first use.
MEROCAINE
SSL Healthcare
2K Local anaesthetic/antiseptic. Cetylpyridinium chlor. 1.4mg, benzocaine 10mg; green lozenge. 24, A2.53. S Relief of pain and discomfort in the mouth. P 1 dissolved in mouth every two hours; max. 8 in 24 hours. Q Under 12 years, not recommended. D Hypersensitivity to the active ingredients. B If symptoms persist, are severe, or are
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
257
12.2 OROPHARYNGEAL
OTOLARYNGOLOGY
PREPARATIONS
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. MEROCETS SSL Healthcare Q Up to 12 years, contraindicated. D Achlorhydria. Pregnancy, lactation. 2K B Predisposition to oral candidosis, hepatic Antiseptic. Cetylpyridinium Cl 1.4mg Lozenge 24, impairment, myasthenia gravis. Avoid excessive A2.33. sunlight or UV (discontinue if phototoxicity S Symptomatic relief of sore throats. occurs). Possibility of oesophageal irritation and Minor irritations of the mouth and throat. ulceration, pseudomembranous colitis, anaphylaxis. V Over 6 years, 1 lozenge sucked three C Drug/food containing bi- or tri-valent hourly or as required. Allow lozenge to dissolve ions, eg. alum., zinc, Ca++, magn., iron, activated slowly in mouth A Rare urticaria, burning sensation of the charcoal, cholestyramine, bismuth chelates, sucralfate, didanosine; take 2-3 hours following mouth. doxycycline. Avoid isotretinoin, penicillin, METRONIDE Clonmel betalactam antibiotics. Caution: Hepatotoxic drugs, methoxyflurane, quinapril, sulfonylurea oral 2MO antidiabetics, anticoagulants, oral contraceptives, Antibacterial. Metronidazole 200mg. White tab. CYP3A4 inducers, ciclosporin, chronic alcohol scored and coded MZL 200 and white scored tab. abuse. coded MZL400. Both marked with twin triangle A Headache, common cold, flu symptoms, logo on reverse. 200mg-21, A1.62. sinusitis, coughing, bronchitis, infection, S Acute ulcerative gingivitis. periodontal abscess, tooth disorder, sore throat, GI P 600mg daily in divided doses for 3 days. disorders, rash, joint, back and tooth pain, Q Under 1 year, not recommended; 1-3 menstrual cramps, accidental injury. years, quarter adult dose; 3-7 years, v tab. twice daily; 7-10 years, half adult dose; over 10 years, as SPORANOX Janssen-Cilag for adults. 2MO B Pregnancy, lactation, liver disease. Azole antifungal. Itraconazole 100mg. blue/ C Alcohol, cimetidine, lithium, oral anti transparent cap. and pink body, size 0. 15, coagulants, phenobarbitone. A26.04. A GI distress, furred tongue, unpleasant S Onychomycosis, systemic mycoses, taste. Urticaria, angioedema, CNS disturbances, dark urine. Neuropathy, epileptiform seizures and pityriasis versicolor, dermatophytoses, oral candidosis. vulvovaginal candidosis. leucopenia on long term therapy. P Onychomycosis, 200mg once daily for 3 MYCOSTATIN ORAL BMS months or 2 pulse treatments for fingernail infections or 3 pulse treatments for toenail 2MO infections. A pulse treatment consists of 2 caps. Antifungal. Nystatin 100 000 units/ml. Ready (200mg) twice daily for 7 days. Pulse treatments mixed susp. 30ml with dropper, A2.91. are separated by a 3-week drug-free interval. S Oral and oesophageal candidosis. Pityriasis versicolor, 200mg once daily for 7 days. V 1ml four times daily held in contact Tinea corporis, tinea cruris, 100mg once daily for 2 with lesions. Continue for 48 hours after clinical weeks. Tinea pedis, tinea manuum, 100mg once cure to prevent relapse. daily for 4 weeks. Fungal keratitis, 200mg once B Should not be used for systemic daily for 3 weeks. Oral candidosis, 100mg once mycoses. Pregnancy, lactation. daily for 2 weeks. Vulvovaginal candidosis 200mg A Rarely oral irritation or sensitivity, twice daily for 1 day or 200mg once daily for 3 nausea. days. W Not recommended. accompanied by fever, headache, nausea and vomiting consult a doctor. C None known. A Allergic reactions, metHbaemia. Sensitisation.
ORABASE
BMS
2
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, ORALDENE McNeil Healthcare marrow transplant and expected to become neutropenic (when standard therapy 2 inappropriate). Antiseptic. Hexetidine 0.1%; soln. 200ml (liq and P 200mg once daily or 100mg twice daily icemint), A2.96. for 1 week. Repeat if necessary. In fluconazole S Oral thrush, gingivitis, stomatitis, resistant patients up to 400mg daily may be taken aphthous and dental ulcers, halitosis. for 2 weeks and repeated if necessary. V Rinse mouth or gargle with 15ml two or W Not recommended. three times daily. D Pregnancy-contraception must be used A Local irritation. during, and for one menstrual cycle after treatment. Lactation. PERIOSTAT Alliance B CHF or history of: Use only if benefit 2M outweighs risks. CHF risk increases with total daily Tetracycline. Doxycycline (hyclate) 20mg. White dose. Transient LV ejection fraction may occur. round tabl. marked PS-20. 56, A 24.07. Caution: Hepatic, renal impairment. Monitor liver
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.
258
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.
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
AURAL 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 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. UCB
PREPARATIONS
12.3
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, nausea, vomiting, diarrhoea, dyspepsia, GI bleeding, peptic ulceration, rash. Very rarely thrombocytopenia.
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. B Limit use to 10 days if ear is perforated. Avoid long-term use in infants. A Superinfection.
12.3 AURAL PREPARATIONS
SOFRADEX
BETNESOL 2MO
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.
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.
EXTEROL
OTOSPORIN
GSK
2NO
sanofi-aventis
2NO Corticosteroid/aminoglycoside/antibiotic.
Dermal Dexamethasone 0.05%, framycetin sulph. 0.5%,
2 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.
2NO
V 4-6 drops 3 or 4 times daily. D Perforated ear drum.
Amdipharm S Otitis media. Removal of ear wax.
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. Leave for at least 20 minutes. Repeat twice daily 2NO for 3 days. Antibiotic/corticosteroid. Gentamicin (as sulph.) D Otitis externa, seborrhoeic dermatitis, 0.3%, hydrocortisone acetate 1%. Drops. 10ml, eczema affecting external ear. Perforated A4.63. eardrum. Allergy to peanuts. S Otitis externa, chronic suppurative otitis B Not to be taken internally. Do not use media. Post-op infected mastoid cavities. for more than 3 days. V 2-4 drops three or four times daily and at night. CILOXAN EAR DROPS Alcon D Perforated ear drum. 2NO B Pregnancy, lactation. Avoid prolonged 4-quinolone. Ciprofloxacin (HCl) 3mg/ml. Clear, use in infants. colourless to pale yellow sln. 5ml, A4.38. A Superinfection. 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.
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.
2 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
259
13.2 ANTI-INFLAMMATORY 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).
EXOCIN
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.
FUCITHALMIC
LEO Pharma
D Sensitivity to acetylsalicylic acid and other NSAIDs. B Coagulagion disorders. Soft contact lenses. Pregnancy, lactation. A Transient stinging, burning and ocular irritation. Blurring and diminished vision.
ALOMIDE
Alcon
2MO
GENTICIN EYE/EAR DROPS
Mast cell stabilisers. Lodoxamide (tometamol)
Amdipharm 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.
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.
BETNESOL
MINIMS CHLORAMPHENICOL
UCB
2MO
Chauvin Corticosteroid. Betamethasone Na+ phos. 0.1%.
2NO 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 Rise in IOP, corneal thinning, cataract, preservatice free; single dose eye drops. 20, A6.93. 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
POLYFAX
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 drops. 5ml, A2.04. 13.2 ANTI-INFLAMMATORY EYE S Non-infected inflammatory ocular PREPARATIONS conditions.
2NO
2NO Fusidic acid. Fusidic acid 1%; viscous eye drops. 5g, A2.63.
2NO ALSO FUCITHALMIC UNIT DOSE Fusidic acid 1% 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.
260
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.
Allergan 2 N O
2NO
OPHTHALMOLOGY
EYE PREPARATIONS
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.
Allergan Q Under 2 years, safety not established.
ACULAR 2MO
NSAID. Ketorolac (trometamol) 0.5%. Sterile soln. 5ml, A8.08. S Prophylaxis and reduction of inflammation following ocular surgery. P One drop instilled into eye 3 times daily starting 24 hours before surgery and continuing for 3 or 4 weeks. Q Not recommended.
V Over 2 years, 1-2 drops into conjuntival sac two to four times daily. D Viral (e.g. keratitis dendritica, varicellazoster infections), bacterial (e.g. tuberculosis) and fungal infections of the eye. Pregnancy, lactation (unless clearly necessary). B Not for use q 1 week except under specialist surveillance and regular IOP measurements. May aggravate herpes simplex virus infections. Contains benzalkonium chloride;
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
total lesion area; or a performed or planned intraocular surgery within previous or next 28 days. If rhegmatogenous retinal detachment or stage 3 or 4 macular holes, discontinue. Pregnancy, lactation; not recommended. If visual disturbances occur, do not drive or use machines until resolved. A Eye disorders: Conjunctival 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. Modified oligonucleotide. Pegaptanib (Na+) V 1-2 drops into each affected eye up to 1.65mg (equiv. 0.3mg free acid form of four times daily. oligonucleotide). Sln for inj. in vial. 1, A640. D Soft contact lenses. S Neovascular (wet) age-related macular A Transient burning or stinging. degeneration (AMD). P One intravitreal inj. every six weeks into LUCENTIS Novartis affected eye. 2J Q Under 18 years, not recommended. Monoclonal antibody. Ranibizumab, 10mg/ml. Soln D Active or suspected ocular or periocular for inj. 1- 0.3ml vial, A1100. 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. outweighs risk). Driving/using machines if blurred dose. Interval between 2 doses r1 month. Patient vision. should self-admin. antimicrobial drops 4 times A Eye disorders, eg. anterior chamber daily for 3 days before and after each inj. inflammation, eye pain, increased intraocular Q Not recommended. pressure, punctate keratitis, vitreous floaters, D Active or suspected ocular or periocular vitreous opacities. Headache, rhinorrhea. infections. Active severe intraocular inflammation. B Intravitreal inj only. Monitor for: MAXIDEX Alcon Infections during week following inj.; IOP and perfusion of optic nerve head. Bilateral treatment, 2 M O previous intravitreal inj.; not studied. Potential for Corticosteroid/lubricant. Dexamethasone 0.1%, hypromellose 0.5%; drops. 5ml, A1.83. immunogenicity. Do not admin. with other antiS Inflammation of anterior segment. VEGF agents. Withhold dose until next scheduled V 1-2 drops hourly for 3-4 days. treatment in event of: Decreased best-corrected 2MO visual acuity of r30 letters; IOP r30mmHg; ALSO MAXIDEX OINTMENT Dexamethasone 0.1%. retinal break; subretinal haemorrhage involving 3g, A2.29. fovea centre, or, if haemorrhage size r50% of avoid contact with soft contact lenses. Remove contact lenses before use; wait for at least 15 min before reinsertion. Adverse topical effects of steroid treatment may occur on facial skin. Admin concomitant ocular medication 5 min prior to FML. If transient blurring of vision occurs, wait before driving/operating machines. A Increased IOP, eye irritation, 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.
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.
PREPARATIONS
13.2
V Apply small amount up to 4 times daily, reducing gradually to once daily for several days. 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,
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
261
13.2 ANTI-INFLAMMATORY opening. A Transient stinging, blurred vision.
OPTREX
OPHTHALMOLOGY
EYE PREPARATIONS
PRED FORTE
Allergan
2NO
Reckitt Benckiser Corticosteroid. Prednisolone (acetate) 1% w/v. Eye
2 Astringent/lubricant. Distilled Witch Hazel 13%. Eye Drops. 10ml, A2.55. 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.
drops. 5ml-A1.78. S Short-term treatment of steroidresponsive inflammatory conditions of the eye, 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 Q Under 2 years, not recommended. infection. Use with soft contact lenses (or 15 mins D Acute untreated purulent ocular before insertion for lotion). infections, superficial herpes simplex (dendritic vaccinia, varicella and most other viral OPTREX CLEAR EYES Reckitt Benckiser keratitis), 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. simplex,prolonged use, glaucoma. May lead to P 1 or 2 drops into each eye, no more perforation in the presence of thin corneal or than 4 times daily. scleral tissue. Not effective in mustard gas keratitis D Glaucoma, serious eye disease, previous and Sjogrenâ&#x20AC;&#x2122;s keratoconjunctivitis. Acute purulent eye surgery. Use with contact lenses except under untreated infection may be masked or activity medical supervision. enhanced by steroids. Contains benzalkonium B Caution: Use on an inflamed eye. High chloride, remove contact lenses and reinsert 15 BP, depression, heart disease, diabetes or mins after. Pred Mild contains Na+ metabisulphite. increased thyroid activity; consult doctor before Driving/using machines (transient blurred vision). use. Consult doctor if: Severe eye pain, changes of A Local irritation, rise in intra-ocular vision or discharge from eye, condition worsens or pressure, posterior subcapsular cataract, secondary persists q 1 day. infection, systemic effects with prolonged use. C Contra: MAOIs (or within 14 days). Caution: Other topically applied autonomic drugs, RELESTAT Allergan antihypertensives, cardiac glycosides, quinidine, 2NO TCAs. Antihistamine/mast cell stabiliser. Epinastine (HCl) (equiv. 0.436mg epinastine). Drops. 5ml, OTRIVINE-ANTISTIN Novartis Consumer A0.5mg/ml 19.72. 2 S Seasonal allergic conjunctivitis. Sympathomimetic/antihistamine. Xylometazoline P 1 drop instilled in affected eye(s) twice (HCl) 0.05%, antazoline sulph. 0.5%. Clear, daily. colourless aqueous eye drops sln. 10ml, A3.52. Q 12 years and older, as for adults. S Symptomatic relief of conjunctival B Remove contact lenses before hyperaemia and oedema associated with allergic application, re-insert after 15 mins. Pregnancy, conjunctivitis. lactation. P 1 or 2 drops, 2 to 3 times daily. A Burning sensation in eye. R 1 drop, 2 or 3 times daily Q Under 12 years, not recommended. SOFRADEX sanofi-aventis D Narrow angle glaucoma. Contact lenses. 2 N O B Hypertension, hyperthyroidism, Corticosteroid/aminoglycoside/antibiotic. diabetes, coronary disease, dry eyes. Caution: sulph. 0.5%, Elderly patients with severe cardiovascular disease Dexamethasone 0.05%, framycetin gramicidin 0.005%; drops. 10ml, A4.85. (incl. arrhythmia); hypertension; diabetes; S Infected ocular inflammation. phaeochromocytoma; conditions causing urinary V 1 or 2 drops three or four times daily. retention (e.g. prostatic hypertrophy). D Viral, fungal, tuberculous or purulent C Contra: MAOIs. Caution: CNS infections. Glaucoma. depressants, other anti-muscarinics, digitalis, bB Prolonged use in pregnancy or infants. adrenergic blockers, guanetidine, reserpine, A Rise in IOP, corneal thinning, cataract, methyldopa, anti-hypertensives, other sympathomimetic drugs. Halogenated anaesthetic fungal infection.
2
agents. A Transient stinging, tachycardia, palpitations, arrythmia, hypertension occipital headache, nausea, paleness and sweating.
262
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.
VISUDYNE
Novartis
2JN Antineovascularisation agent. Verteporfin 15mg. Powder for sln for inf. 15mg vial, A1180.46. S Exudative (wet) age-related macular degeneration (AMD) with predominantly classic subfoveal choroidal neovascularisation (CNV). Subfoveal choroidal neovascularisation secondary to pathological myopia. P 1st step: 10-min IV inf. 6mg/m2, diluted in 30ml inf. sln. 2nd step: Light activation 15 min after start of inf. Re-evaluated every 3 months. In the event of recurrent CNV leakage, may be given up to 4 times per year. Q Not recommended. D Porphyria, severe hepatic impairment. Pregnancy (unless clearly necessary), lactation. B Photosensitivity for 48 hours after inf. Avoid sunlight but not ambient indoor light (help eliminate drug). Caution: Moderate hepatic impairment or biliary obstruction, general anaesthesia. Unstable heart disease, uncontrolled arterial hypertension (no data). Driving/using machines. C Caution: Other photosensitising agents. A Abnormal vision, severe vision decrease, pain, oedema, inflammation, extravasation, infrelated back/chest pain, nausea, photosensitivity reaction, asthenia, hypercholesteraemia. Vasovagal and hypersensitivity reaction.
VIVIDRIN
Dr. Mann
2O
Mast cell stabiliser. Sodium chromoglycate 2 %. Sterile eye drops. 13.5ml, A5.85. S Prevention and treatment of acute allergic conjuntivitis (hay fever), chronic allergic conjunctivitis (inflammation) of the eye lids and vernal kerato-conjunctivitis (vernal or spring catarrh). Alcon V One drop into each eye four times daily.
VEXOL 2MO
2O
Corticosteroid. Rimexolone 1%; drops. 5ml, A5.49.
ALSO VIVIDRIN SINGLE DOSE Sodium
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 P 1 drop twice daily approx. 12 hours apart. Q Under 12 years, not recommended. D Neonates and infants under 2 years. Lactation. B Severe CVD. Depression, cerebral or coronary insufficiency, Raynaud’s syndrome, orthostatic hypotension, thromboangiitis obliterans. Renal / hepatic impairment. Children 2VOLTAROL OPHTHA Novartis 7years and/or weighing Q 20 kg: Caution, high incidence of somnolence. Pregnancy (only if 2MO benefit outweighs risk). Discolours soft contact NSAID. Diclofenac Na+ 0.1%. Drops. 5ml, A5.39. lenses. Remove contact lenses prior to application S Inhibition of miosis in cataract surgery, post-op. inflammation. Non-infective inflammatory and wait 15min before reinsertion.Driving/ conditions of the anterior segment, inflammation operating machinery. C Contra: MAOIs, antidepressants following trauma, pain post-PRK surgery, affecting NA transmission (eg. TCAs, mianserin). prophylaxis of cystoid macula oedema. Caution: CNS depressants, antihypertensives, ZADITEN Novartis cardiac glycosides, drugs affecting circulating amines (chlorpromazine, methylphenidate, 2MO reserpine), sympathomimetics agonists or Antihistamine/mast cell stabiliser. Ketotifen 0.25%. antagonists. Eye drops. 5ml, A9.79. A Eye disorders incl. allergic reactions S Seasonal allergic conjunctivitis. (hyperaemia, stinging, conjunctival follicles, P 1 drop twice daily. pruritis). Dry mouth, headache, fatigue, Q Under 12 years, not recommended. drowsiness, dizziness, abnormal taste, upper D Soft contact lenses - reinsert after 15 respiratory symptoms. mins. B Caution in pregnancy. AZARGA Alcon A Burning/stinging, blurring of vision, dry eyes, headache, somnolence, skin rash, dry mouth, 3 O Carbonic anhydrase II inhibitor/b-blocker. allegic reaction. Brinzolamide 10mg and timolol (as maleate) 5mg. 13.3 GLAUCOMA Eye drops. White to off-white uniform suspension, pH 7.2. 5ml, A15.13. ALPHAGAN Allergan P 1 drop in conjunctival sac of affected 2MO eye(s) twice daily. Max dose: 1 drop twice daily. Q Under 18 years, not recommended. a2-agonist. Brimonidine (tartrate) 0.2% (2mg/ml, D Bronchial asthma, history of bronchial equiv. brimonidine 1.3mg/ml). Eye drops, clear asthma, or severe chronic obstructive pulmonary greenish-yellow sln. 5ml, A13.17. disease. Sinus bradycardia, 2nd or 3rd degree S Reduction of elevated intraocular atrioventricular block, overt cardiac failure, or pressure (IOP) in open-angle glaucoma or ocular cardiogenic shock. Severe allergic rhinitis and hypertension . As monotherapy where b-blockers bronchial hyperreactivity; Hyperchloraemic contraindicated or as adjunctive therapy where target IOP not achieved with a single agent. acidosis. Severe renal impairment. Hypersensitivity 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.
PRESCRIBING NOTES GLAUCOMA Approved first line treatments for chronic simple glaucoma include beta-blockers and prostaglandins latanoprost and travoprost. Other 1st choice treatments include carbonic anhydrase inhibitors and selective alpha2-agonist while 2nd choice agents include adrenergics, cholinergics and guanethidine. If the first choice monotherapy alone is not effective on intraocular pressure (IOP) or not tolerated, it is preferable to switch to any of the other topical agents that can be initiated as monotherapy. If the 1st 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
GLAUCOMA 13.3 to sulphonamides. Pregnancy (unless clearly necessary). B Adverse reactions as seen with systemic b-blockers may occur (See 2.4 b-blockers Drug Prescribing Note). Acid-base disturbances reported. Discontinue if signs of serious reactions or hypersensitivity occur. Caution: Pseudoexfoliative glaucoma, pigmentary glaucoma (monitoring of IOP recommended). Not recommended for narrow-angle glaucoma. May impair mental alertness and/or physical coordination in elderly. Careful monitoring recommended: Contact lenses wearers, patients with compromised corneas. Contains benzalkonium chloride (monitor with frequent or prolonged use, remove contact lenses before application, wait 15 min to reinsert). May temporarily blur vision, caution if driving/ operating machines. C Not recommended: Concomittant oral carbonic anhydrase inhibitors. Caution: CYP3A4 inhibitors, oral Ca++ channel blockers, guanethidine or b-blockers, antiarrhythmics, digitalis glycosides or parasympathomimetics, clonidine, CYP2D6 inhibitors, antidiabetic agents. A Dysgeusia, blurred vision, eye pain, eye irritation, foreign body sensation in eyes. See also 2.4 b-blockers Drug Prescribing Note.
AZOPT
Alcon
2NO Carbonic anhydrase II inhibitor. Brinzolamide 10mg/ml. Drops. 5ml, A10.05. S Ocular hypertension, open angle glaucoma as monotherapy in patients unresponsive to b-blockers or as adjunctive therapy to b-blockers. P One drop instilled into affected eye(s) twice daily increase if necessary to one drop three times daily. Q Not recommended. D Hypersensitivity to sulphonamides. 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.
BETAGAN
Allergan
3MO b-blocker. Levobunolol (HCl) 0.5%; drops with compliance device. 5ml, A5.79, 15ml (3x5ml), A13.88.
3MO ALSO BETAGAN UNIT DOSE Levobunolol (HCl) 0.5%; preservative-free soln. in single dose units. 30 x 0.4ml, A10.67. S Control of intraocular pressure in chronic open angle glaucoma and ocular hypertension. P 1 drop once or twice daily. Q Not recommended. D Reactive airway disease incl. bronchial asthma, severe COPD. Sinus bradycardia, 2nd and 3rd-degree AV block not controlled with pace maker, overt cardiac failure, cardiogenic shock. Pregnancy, lactation. B In angle-closure glaucoma use with a miotic. Caution: Severe / unstable and uncontrolled CV disease (incl. 1st degree AV block), haemodialysis, metabolic acidosis, untreated phaeochromocytoma, spontaneous hypoglycaemia / uncontrolled diabetes, depression,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
263
13.3 GLAUCOMA
OPHTHALMOLOGY
cerebral / coronary insufficiency, Raynaudâ&#x20AC;&#x2122;s phenomenon, orthostatic hypotension, thromboangiitis obliterans, chronic eye inflammation and corneal dystrophy (only use in stringent diagnosis; monitor continuously), history of atopy/severe anaphylactic reaction. May occur: Cardiac and respiratory reactions, choroidal detachment (after filtration procedures). May mask signs of hyperthyroidism and cause worsening of Prinzmetal angina, severe peripheral, central circulatory disorders, hypotension. Contains 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, IV lidocaine, cimetidine, chlorpromazine, methylphenidate, reserpine, prostamides, prostaglandins, a-agonists, carbonic anhydrase inhibitors, pilocarpine. A Eye irritation, conjunctival irritation, blepharitis, conjunctivitis.
D Sinus bradycardia, cardiogenic shock, uncompensated cardiac failure, soft lenses. B History of obstructive airways disease, diabetes, thyrotoxicosis. General anaesthesia. A Transient discomfort. Rarely decreased corneal sensitivity, erythema, corneal punctate staining, keratitis.
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
COMBIGAN
Allergan (as HCL) 20mg/ml and timolol (as maleate) 5mg/ml.
3MO
a2 adrenergic agonist/b-blocker. Brimonidine tartrate 2mg/ml, timolol 5mg/ml. Eye drops, clear greenish-yellow soln. 5ml, A14.55. S Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently 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. BETOPTIC Alcon Remove contact lenses prior to use; reinsert after 15 mins. 3MO C Contra: MAOIs (within 14 days), Cardio-selective b-blocker. Betaxolol (HCl) 0.5%; antidepressants affecting NA transmission (e.g. drops. 5ml, A7.34. TCAs, mianserin). See 2.4 b-blockers Drug Presc. 3MO Notes. ALSO BETOPTIC SUSP. Betaxolol (HCl) 0.25%. A Allergic reactions (discontinue), Clear, colourless to pale yellow sterile, eye drops conjunctival hyperaemia, burning sensation, eye/ A solution. 0.25ml single dose-50, 11.61. eyelid disorders, depression, somnolence, S Ocular hypertension, chronic open-angle headache, hypertension, oral dryness, asthenic glaucoma. conditions, LFTs abnormal. P 1 drop twice daily. Q Not recommended.
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. P 1 drop in the affected eye twice daily. R Not recommended. D See 2.4 b-b-blockers Drug Presc. Notes. Severe renal impairment, hyperchloraemic acidosis. B See 2.4 b-b-blockers Drug Presc. Notes. History of renal calculi, hypersensitivity to sulphonamides. Pre-existing chronic corneal defects, history of intraocular surgery. Acute angle-closure glaucoma, no data. Soft contact lenses (no data on preservative-free). C Leave an interval of 10 minutes if applying other topical ophthalmic agents. Oral bBlockers, quinidine and SSRIs. Caution: See Prescribing Notes on b-blockers section 2.4. A Headache, eye burning and stinging, eyelid inflammation/ irritation, ocular irritation, sinusitis, taste perversion, nausea, fatigue.
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 Beta-blockers Unless otherwise specified, beta-blockers are prohibited in-competition only in the following sports:
Aeronautic (FAI)
5NO
Automobile (FIA)
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, diabetes, pregnancy, monitor fluid, electrolytes and blood. C Folic acid antagonists. A Flushing, thirst, headache, drowsiness, polyuria paraesthesia excitement, bloody dyscrasias, rash.
Billiards and Snooker (WCBS) Bobsleigh (FIBT) Boules (CMSB) Bridge (FMB) Curling (WCF) Golf (IGF) Gymnastics (FIG) Motorcycling (FIM) Modern Pentathlon (UIPM) for disiplines involving shooting
DUOTRAV
Ninepin and Tenpin bowling (FIQ)
Alcon
3MO
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)
264
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.
Prostaglandin analogue/b-blocker. Travoprost 40mcg, timolol 5mg/ml. Clear eye drops. 2.5ml, A16.71. S Decrease of IOP in patients with openangle glaucoma or ocular hypertension who are insufficiently responsive to topical b-blockers or prostaglandin analogues. P 1 drop once daily, in the morning or evening, at the same time each day. Q Under 18 years, not recommended. D See 2.4 b-blockers Drug Presc. Notes. Corneal dystrophies.
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 B See 2.4 b-blockers Drug Presc. Notes. Rarely respiratory/cardiac reactions can cause death. Caution: Diabetics, aphakia, pseudophakic, risk factors for spontaneous hypoglycaemia, cystoid macular oedema or iritis/uveitis. May change eye colour, eyelashes and cause permanent heterochromia. Contains benzalkonium chloride, polyoxyethylene hydrogenated castor oil 40. Remove contact lenses prior to use, wait 15 min. to reinsert. Pregnancy (unless clearly necessary), lactation. C See 2.4 b-blockers Drug Presc. Notes. A Nervousness, dizziness, headache, eye disorders (See SPC), irregular heart rate, BP increase/decrease, heart rate decrease, bronchospasm, urticaria, skin hyperpigmentation, pain in extremity.
GLAUCOMA 13.3 uncontrolled CVD. Soft contact lenses. B Angina, severe coronary insufficiency, recent MI, cardiac failure, cerebrovascular disease, chronic renal failure, Raynaud’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.
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. LUMIGAN Allergan Q Not recommended. 2NO D Closed angle glaucoma. Soft contact Prostaglandin analogue. Bimatoprost 0.3mg/ml. lenses. A Eye-drops, soln. in 3 ml bottle. 1, 16.24; 3, B Narrow angles. Aphakia. A38.34. A Transient stinging. Rebound GANDA 3 + 0.5% Chauvin S Reduction of elevated intraocular hyperaemia. Allergic reactions (rare). 2MO pressure in chronic open angle glaucoma and ocular hypertension as monotherapy or adjunctive TIMOPTOL Adrenergic neurone blocker/sympathomimetic. MSD therapy to b-blockers. Guanethidine monosulph. 3%, adrenaline 0.5%. 3MO P 1 drop in affected eye(s) once daily, in Sterile eye drops. 7.5ml, A8.32. b-blocker. Timolol (as maleate) 0.25%, 0.5% w/v. the evening. S Glaucoma. Metered dose-0.25% x 5ml, A4.67; 0.5% x 5ml, Q Under 18 years, not recommended. P 1 drop once or twice daily. A4.67. D Pregnancy, lactation. Q As instructed by the practitioner. S Ocular hypertension, chronic open angle B Renal, respiratory impairment. D Narrow angle glaucoma. glaucoma, secondary glaucoma. B Examine conjunctiva and cornea every 6 Moderate to severe hepatic impairment. Patients P Initially 1 drop of 0.25% soln. twice at risk of macular oedema. Monitor dry eye months during long term use; discontinue if daily changing to 0.5% soln. twice daily if patients (keratopathy). Contact lenses (remove damage is seen. Pregnancy, lactation. required. prior to admin., wait 15min before reinsertion). C MAOIs. Q Not recommended. A Eyelash growth, darkening of eyelids, A Conjunctival vasodilation, burning D See 2.4 b-blockers Drug Presc. Notes. increased iris pigmentation (warn patient). sensation. Systemic effects (rare). Paradoxical rise Soft lenses (metered dose and LA). Conjunctival hyperaemia/oedema, allergic in pressure, ptosis, superficial punctate keratitis. B Withdraw gradually. Advise patients to conjonctivis, asthenopia, bepharitis, cataract, report any intercurrent ocular conditions. Monitor GANFORT Allergan corneal erosion, eyelid erythema/pruritus, ocular cardiac function and treatment following filtration pruritus or irritation/discomfort, superficial 3MO procedures. Diabetes. Pregnancy, lactation. punctate keratitis, visual disturbance, worsening Prostamide/b-blocker. Bimatoprost 0.3mg/ml, C See 2.4 b-blockers Drug Presc. Notes. timolol (as maleate) 5mg/ml. Colourless eye drops. visual acuity. Headache, elevated liver function, Other topical and systemic b-blockers. hypertension. 3ml, A21.29. S Decrease of IOP in patients with openAlcon MINIMS PILOCARPINE Chauvin TRAVATAN angle glaucoma or ocular hypertension who are 2NO 2MO insufficiently responsive to topical b-blockers or Prostaglandin analogue. Travoprost 40mcg/ml. prostaglandin analogues. Cholinergic. Pilocarpine nitrate 2% and 4%, P 1 drop once daily, in the morning. preservative free; single dose eye drops. 20, A5.93. Drops. 2.5ml, A16.29. S Decrease of elevated intraocular Q Under 18 years, not recommended. S Emergency treatment of glaucoma. As a pressure in patients with ocular hypertension or D See 2.4 b-blockers Drug Presc. Notes. miotic to reverse weaker mydriatics. open-angle glaucoma who are intolerant or P 1-2 drops as required. B See 2.4 b-blockers Drug Presc. Notes. insufficiently responsive to other intraocular D Acute iritis, anterior uveitis. Rarely respiratory/cardiac reactions can cause pressure lowering medications, as monotherapy or death. Caution: Diabetics, aphakia, pseudophakic, B Caution with use in inflamed eye. as adjunctive therapy. C Corticosteroids, anticholinergics. known risk factors for cystoid macular oedema. A Can cause spasm of the ciliary muscle. P One drop in the conjunctival sac of May change eye colour, eyelashes, eye lid skin Local irritation, headache. affected eye(s) once daily preferably in the (may be permanent). Contains benzalkonium evening. chloride. Remove contact lenses prior to use, wait NYOGEL Novartis Q Not recommended. 15 min. to reinsert. Monitor frequent/prolonged D Pregnancy, lactation. Soft contact lenses. use in dry eye patients or where cornea 3MO compromised. Pregnancy (unless clearly necessary), b-blocker. Timolol 0.1%; gel. 5ml, A3.19. lactation. S Ocular hypertension, chronic open-angle C See 2.4-b-blockers Drug Presc. Notes. glaucoma. A Eye disorders, blepharal pigmentation. P 1 drop into each affeted eye once daily in the morning. IOPIDINE 0.5% Alcon Q Not recommended. D See 4.2 b-b-blockers Drug Presc. Notes. 2NO This medicinal product contains Corneal dystrophies, severe allergic rhinitis. a2-adrenergic agonist. Apraclonidine (HCl) 0.5% substance(s) prohibited for use and benzalkonium (Cl ) as preservative. 5ml, PILOGEL Alcon A12.29. in specific sports only (as listed 2MO S Short term adjunctive treatment of in WADA Prohibited List 2010). Cholinergic. Pilocarpine (HCl) 4%; ophthalmic gel. chronic glaucoma to delay laser treatment or Athletes requesting to use this 5g, A7.60. surgical procedures. P 1 drop in the affecred eye(s) three times S Glaucoma. product in these specific sports daily. Allow 5 min, interval between instillation of P Apply approx. 1-1.5 cm gel to lower are required to apply for a TUE. different medications. conjunctival sac once daily at bedtime. Q Not recommended. Q Not recommended. D History of severe, unstable or D Acute iritis, soft contact lenses.
Anti-Doping Information
s
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
265
13.4 OCULAR
OPHTHALMOLOGY
LUBRICANTS
Eye drops soln. 2.5ml, A17.11. S Reduction of elevated IOP in patients with open angle glaucoma and ocular hypertension. P 1 drop in affected eye(s) once daily, preferably in the evening. Q Not recommended. D Contact lenses. Pregnancy, lactation. B Inflammatory, neovascular, angle closure or congenital glaucoma, pigmentary 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 Treatment of all forms of dry eye. Instill hyperchloraemic acidosis. B Hepatic impairment, acute angle-closure one drop into conjunctival sac 3 to 5 times daily as required. glaucoma. History of renal calculi. Consider B Gradual change in eye colour. Macular oedema, incl. cystoid macular oedema. Avoid skin contact. Prolonged use in dry eyes or where cornea is compromised. Do not drive or operate machinery if blurred vision occurs. A Ocular hyperaemia, ocular pruritus, irritation and discomfort, iris discolouration, photophobia, keratitis, flare, tearing, blurred vision, conjunctivitis, iritis, lid oedema. Hypotension, bradycardia, periorbital skin discolouration.
discontinuation if allergic reactions occur. Caution: 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
Pfizer
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. D See 2.4 b-blockers Drug Presc. Notes. B See 2.4 b-blockers Drug Presc. Notes. Latanoprost may gradually change eye colour, increasing the amount of brown pigment; advise patient. Caution in inflammatory, neovascular, chronic angle closure or congenital glaucoma; in open angle glaucoma of pseodophakic patients, pigmentary glaucoma and in closed angle glaucoma (acute attacks). Soft contact lenses. Pregnancy, lactation. C See 2.4 b-blockers Drug Presc. Notes. A Increased iris pigmentation. Darkening, thickening and lengthening of eyelashes. Eye irritation. See 2.4 b-blockers Drug Presc. Notes.
XALATAN
Pfizer
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). 0.5ml x 30, A5.18; 0.5ml x 60, A8.88. S 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 administered.
CELLUVISC 2OY
2OY ALSO CELLUVISC 0.5% Carmellose Na+ 5mg/ml (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. Chauvin
2NO
2O
Prostaglandin analogue. Latanoprost 50mcg/ml.
Lubricant/tear substitute. Carbomer 980 0.2%; gel.
266
ILUBE
Alcon
2NO Lubricant/tear substitute. Acetylcysteine 5%, hypromellose 0.35%; drops. 10ml with dropper, A4.92. S Dry eye syndromes particularly associated with abnormal mucous production. V 1 or 2 drops three or four times daily. D Soft contact lenses.
LACRI-LUBE
Allergan
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.
LIPOSIC
Dr. Mann
2KO Lubricant/tear substitute. Carbomer 2mg/g. Also containing triglycerides. Gel. 10g, A3.38. S All forms of dry eye, particularly where lipid layer is deficient. V Admin. up to 5 times daily and at night.
LIQUIFILM TEARS
Allergan
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.
LIQUIVISC
Allergan
Allergan 2 O Y
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.
GELTEARS
10g, A2.68. S Dry eye conditions. V 1 drop 3-4 times daily. D Soft contact lenses.
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 inferior conjunctival cul-de-sac 1 to 4 times daily according to the degree of ocular trouble. Q Not recommended. B Contact lenses (reinsert 30 min. after instillation). Pregnancy, lactation (not studied). C Other eye drops, wait 15 min. and instil Liquivisc last. A Transient stinging or burning. Blurred vision until gel is evenly distributed over eye.
MINIMS ARTIFICIAL TEARS Chauvin 2O 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 required.
MINIMS SODIUM CHLORIDE Chauvin
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
MYDRIATICS, ANAESTHETICS
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 REFRESH OPHTHALMIC Allergan more frequently during the day and before retiring at night. 2Y Lubricant. Polyvinyl alcohol 1.4%, povidone 0.6%. D Undiagnosed conjunctivitis. Use with contact lenses. Soln. in unit dose vial. 30 x 0.4ml, A4.33. B Use 5 mins. after use of other S Artificial tear in dry eye and other conjunctival medications. ocular irritation syndromes. C Use 5 mins. after use of other V 1-2 drop in each eye as required or conjunctival medications. directed. A Blurring of vision especially when B Remove contact lenses before application, re-insert after 15min. Discontinue and administered. consult doctor if irritation, pain, redness and 13.5 MYDRIATICS, ANAESTHETICS AND changes in vision occur or worsen. Driving/using STAINS machines. C Admin. concomitant ocular medication FLUORETS Chauvin 15 mins. prior to use. 2NO A Transient stinging or irritation. Diagnostic strip. Fluorescein Na+ 1mg; SNO TEARS Chauvin impregnated strip. 100, A8.39. S Diagnostic examinations, incl. Goldmann 2O tonometry and contact lens fitting. Lubricant/tear substitute. Polyvinyl alcohol 1.4%; V One moistened strip stroked across Eye drops. 10ml, A1.28. S Ocular lubrication for relief of dry eyes. eyeball. B Use once only and discard. V One or more drops as required. D Soft contact lenses.
2
Isotonic saline. Sodium Cl 0.9%, preservative free. single dose drops. 20, A6.98. S Irrigation of the eye. V As required.
AND STAINS
13.5
Anticholinergic. Cyclopentolate (HCl) 1%, preservative free; single dose eye drops. 20, A5.93. S Mydriatic and cycloplegic for ophthalmic examination and treatment. V 1 or more drops as required; see lit. D Narrow angle glaucoma or shallow anterior chamber. Neonates. B Use with caution in inflamed eye. A Local irritation, hyperaemia, oedema, conjunctivitis. Systemic effects (rare).
MINIMS FLUORESCEIN
Chauvin
2NO Stain. Fluorescein Na+ 1%, 2%, preservative free; single dose eye drops. 20, A5.93. S Diagnostic stain for locating abrasions and foreign particles, Goldmann tonometry; fitting of hard contact lenses. V 1 or more drops as required. D Soft contact lenses. B Avoid microbial contamination.
MINIMS LIGNOCAINE AND FLUORESCEIN Chauvin 2N
Local anaesthetic/stain. Lignocaine (HCl) 4%, fluorescein Na+ 0.25%, preservative free. single dose eye drops. 20, A9.84. S Ophthalmic procedures incl. tonometry. 1 or more drops as required. MINIMS AMETHOCAINE Chauvin P Q At discretion of physician. TEARS NATURALE Alcon 2 N O B Cornea may be damaged by prolonged Topical anaesthetic. Amethocaine (HCl) 0.5%, 1%, use. Protect eye from dust and contamination. 2O preservative free. Single dose eye drops. 20, Hyperaemia. Tear substitute. Dextran 70 0.1%, hypromellose A6.55. 0.3%; drops. 15ml, A2.04. S Topical anaesthesia for ophthalmic MINIMS PHENYLEPHRINE Chauvin S Tear deficiencies. procedures. 2MO V 1 or 2 drops as required. V 1 drop or as required. D Soft lenses. Sympathomimetic. Phenylephrine (HCl) 2.5%, 10%, B Protect eye from dust and preservative free. single dose drops. 20, A6.93. VIDISIC GEL Dr. Mann contamination. Corneal damage after prolonged S Mydriatic for diagnostic or therapeutic use. Hyperaemia. 2O procedures. C Sulphonamides. P 1 drop of either strength as required. Tear substitute. Polyacrylic acid 0.2%, cetrimide A Dermatitis, transient burning sensation. Q 1 drop of 2.5% soln. as required. 0.01%, sorbitol 4%, Na+ edetate 0.01%, sodium hydroxide 0.084%; aqueous gel. 10g, A2.93. MINIMS ATROPINE Chauvin D Narrow angle glaucoma, hypertension, coronary disease, contact lenses, long term insulin 2O 2M dependant diabetes, hyperthyroidism. ALSO VIDISIC SINGLE DOSE UNIT PRESERVATIVE Anticholinergic. Atropine sulph, 1%, preservative B Hyperaemia. free; single dose drops. 20, A6.98. C b blockers, MAOIs, tricyclic PRESCRIBING NOTES S Mydriatic and cycloplegic. antidepressants, adrenergic-blockers, OCULAR LUBRICANTS V 1 drop as required. phenothiazines. Are used to correct tear deficiency caused by D Narrow angle glaucoma or shallow A Irritation, punctate keratitis, corneal reduced or abnormal tear secretion. anterior chamber. oedema, pigment floaters. Hypromellose is the most popular preparation B Cornea may be damaged by prolonged but for the patient the frequent application may use. Protect eye from dust and contamination. MINIMS ROSE BENGAL Chauvin prove problematic. In comparison carbomers Hyperaemia. 2 (polyacrylic acid), polyvinyl alcohol, polyethylene A Local irritation, hyperaemia, oedema, Stain. Rose Bengal 1%w/v, preservative free; single glycol and dextran preparations increase the conjunctivitis dose, sterile eye drops. 20, A8.15. persistence of the tear film and are especially MINIMS BENOXINATE Chauvin S As a diagnostic stain. Location of useful when the mucin layer is inadequate and degenerated cells in dry eye syndrome, particularly tear distribution patchy. They may be more 2MO Sjr¨gren’s syndrome. acceptable to patients as the number of Topical anaesthetic. Oxybuprocaine (HCl) 0.4%, V 1 or 2 drops as required. applications is reduced. preservative free; single dose eye drops. 20, A5.93. D Dry eyes. Pregnancy, lactation (only if Acetylcysteine is able to breakdown the mucous S Anaesthesia of cornea and conjunctiva essential). molecules, and is useful when there is an for ophthalmic procedures. B Contact lenses, driving or operating V 1 or more drops as required. overproduction of mucus and in cases where hazardous machinery. B Cornea may be damaged by prolonged A May discolour the eyelids/conjunctiva. surface mucin is abnormal. It is often combined use. Protect eye from dust and contamination. in preparations with hypromellose. Sodium Hyperaemia. MINIMS TROPICAMIDE Chauvin chloride is indicated for general eye irrigation. C Chlorhexidine acetate. 2N Eye ointments containing paraffin can also lubricate the eye. As they cause visual disturbance, they are best applied before sleep. References available on request.
MINIMS CYCLOPENTOLATE Chauvin
2MO
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
267
14.1 ANTI-ALLERGIC
ALLERGY
DRUGS
supervision. Begin 4 months before pollen season (efficacy may also occur if start 2-3 months before season). Continue daily for 3 years (progressive immunomodulatory effect). Do not continue if no relevant improvement occurs in 1st year. W No data. D Malignancy or systemic diseases 14.1 ANTI-ALLERGIC DRUGS affecting immune system. Inflammatory conditions in oral cavity with severe symptoms. Uncontrolled/ Rowex severe asthma. MYDRIACYL Alcon CETRINE 2MO B Oral surgery. If local adverse reactions 2NO occur consider anti-allergic medication. Non-sedative antihistamine. Cetirizine (diHCl) Anticholinergic. Tropicamide 0.5%, 1%; drops. Discontinue and consult physician if: Severe 10mg. White oblong film-ctd tab. scored on one 0.5%-5ml, A1.59; 1%-5ml, A1.96. systemic reactions occur; deterioration in asthma side. 10mg-30, A6.08. S Mydriatic and cycloplegic (with rapid signs/symptoms. Severe allergic reactions may be 2K recovery of accommodation) for refraction. treated with adrenaline. Simultaneous vaccination. ALSO CETRINE ALLERGY Cetirizine (diHCl) 10mg. V 1 or 2 drops of either strength at 1-5 Contains fish derived gelatine. Pregnancy. White oblong film-ctd tab. scored on one side. 7, min. intervals. If patient not examined within 30 C Use with symptomatic anti-allergics may A3.10; 28, A6.65. min. an additional drop should be used. S Seasonal and perennial allergic rhinitis, increase patients tolerance. D Narrow angle glaucoma. Soft lenses. A Headache, oral paraesthesia, eye/ear/ urticaria, senile pruritus. B Unknown IOP. In infants put pressure skin pruritus, conjunctivitis, throat irritation, Q Under 6 years, not recommended. over lachrymal sac for 1 min. sneezing, cough, asthma, pharyngitis, rhinorrhoea, V 1 daily. Moderate renal impairment: A Transient stinging, dry mouth, blurred nasal congestion/passage irritation, rhinitis, throat 5mg once daily. Severe renal impairment: 5mg vision, photohobia, tachycardia, headache. tightness, GI disorders, fatigue. once every 2 days. Psychotic reactions, behavioural changes. D Lactation. End-stage renal disease HISTACLAR Gerard MYDRILATE Intrapharm Labs. (ccQ10ml/min). B Significant renal impairment or 2MO 2MO decreased hepatic function. Pregnancy. Contains Antihistamine. Loratadine 10mg. White film-ctd Anticholinergic. Cyclopentolate (HCl) 0.5% and lactose. tab. scored one side, marked LR10 on reverse. 7, 1%; drops. 0.5%-5ml, A1.45; 1%-5ml, A1.67. C Caution: CNS depressants (insufficient A3.32 (OTC, non-GMS); 30, A8.49. S Cycloplegic and mydriatic for refraction. data). S Relief of symptoms associated with P Refraction-1 drop of 0.5% soln. A Minor CNS disturbances, eg. allergic rhinitis (perennial and seasonal), idiopathic repeated 15-20 min. later if necessary. somnolence, fatigue, dizziness, headache. chronic urticaria. Q Refraction-under 6 years, 1 or 2 drops P 1 once daily before food. of 1% soln; over 6 years, 1 drop of 1% soln. DEPO-MEDRONE Pharmacia Q Under 12 years, not recommended; over 12 years, same as adults. 0NO PRESCRIBING NOTES B Severe hepatic disorders. Discontinue 4 MYDRIATICS, ANAESTHETICS AND STAINS Glucocorticoid: (Prohibited in Competition when days prior to skin test. Dry mouth with risk of LOCAL ANAESTHETICS: The two main local given by intra-muscular route. See monograph in anaesthetics employed are oxybuprocaine and caries during long-term treatment. Section 6.2 for peri- and intra-articular amethocaine, which act within a few seconds administration) Methylprednisolone acetate 40mg/ A Fatigue, headache, increased appetite, and their effect wears off after a few hours. They GI disorders such as nausea, gastritis, dyspepsia, ml. Susp. for inj. in vials. 1 x 1ml, A2.97; 1 x 2ml, produce adequate anaesthesia for removal of dry mouth and nose bleeding, pharyngitis. A5.33; 1 x 3ml, A7.73. foreign objects and applanation tonometry. A S Severe seasonal and perennial allergic compound preparation of lignocaine and HISTEK Helsinn Birex rhinitis. fluorescein is can also be used for tonometry. 2MO P 80-120mg (2-3ml) IM See SPC. MYDRIATICS act on the eye by dilating the Antihistamine. Cetirizine (diHCl)10mg. White oval Q Dose depends on condition and to a pupil and paralysing the ciliary muscle. They are scored tab. 7 (OTC), A2.21; 30, A5.84. lesser extent body weight and patient age. either antimuscarinic (atropine, cyclopentolate, S Treatment of perennial rhinitis, seasonal D See SPC. Do not give via intrathecal or homatropine, tropicamide) or sympathomimetic allergic rhinitis (hay fever), chronic idiopathic IV routes. (phenylephrine) in action. They differ in their urticaria. B Elderly, children, diabetes, chronic potency and duration of action. Tropicamide is short acting, lasting only a few hours, and P 1 daily. Renal or hepatic impairment, psychoses, CHF, renal insufficiency, glaucoma, causes little cycloplegia. Atropine can work for 5mg daily. osteoporosis. See SPC. up to a couple of weeks and produces a Q Under 12 years, not allowed; over 12 C Cyclosporin, warfarin, salicylates. profound cycloplegia; it can also be used in years, same as adult. A Hypersensitivity, GI disorders, elevated conjunction with phenylephrine when maximum D Lactation. liver function tests, anti-inflammatory and cycloplegia is required. Mydriasis can cause B Moderate to severe renal impairment, immunosuppressive effects, musculoskeletal acute angle closure glaucoma, usually in hepatic impairment. Pregnancy. effects, fluid and electrolyte disturbances, skin patients over 60 who are long sighted and have C Alcohol and CNS depressants (avoid). disorders, endocrine and metabolic disorders, a shallow anterior chamber making them Theophylline. neuropsychiatric disorders, ophthalmic disorders, susceptible to this effect. Patients should be A Headache, dizziness, drowsiness, leucocytosis, thromboembolism, malaise, warned not to drive until the effects of the drugs agitation, rash, nausea, palpitations, dry mouth, GI withdrawal symptoms. have worn off. DIAGNOSTICS: Fluorescein discomfort. sodium and rose bengal are used to detect 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.
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.
268
V Mydriasis-1 drop 0.5% or 1% as required. D Paralytic ileus. B Raised IOP. Prostatic enlargement, coronary insufficiency. A Systemic anticholinergic effects.
GRAZAX
ALK
2M Allergen extract. Standardised allergen extract of grass pollen from Timothy (Phleum pratense) 75,000 SQ-T. White circular oral lyophilisate debossed with an image on one side. 30, A75.00 (GMS-restricted prescriber list). S Grass pollen induced rhinitis and conjunctivitis in adults with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen. P 1 daily. 1st dose under medical
KENALOG
BMS
0NO Glucocorticoid (Prohibited in Competition when given by intra-muscular route. See monograph in Section 6.2 for intra-articular administration). Triamcinolone acetonide 40mg/ml. 1ml, 2ml prefilled syringes for IM use only. 1ml, A2.46; 2ml, A4.26. S Allergic states, adrenocortical insufficiency, collagen disorders, severe dermatitis. P Initially 40mg injected deeply into
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 gluteal muscle, then according to response. Hay fever or pollen asthma, 40-100mg as single inj. Q Under 6 years, not recommended; 6-12 years, adjust adult dose according to age, weight and severity. D Systemic infections unless specific antiinfective therapy is employed. Admin. by IV, intrathecal or intraocular inj. B Risk of increased susceptibility to infections and their severity. Recent intestinal anastomoses, thrombophlebitis, psychotic tendencies, exanthematous disease, chronic nephritis, metastatic carcinoma, osteoporosis, active peptic ulcer (or history); latent or healed 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 obtained; avoid inj. into the tendon itself if inj. are given into tendon sheaths; avoid repeated inj. into inflamed tendons. Do not inj. into achilles tendon. IM inj.: During prolonged therapy a liberal protein intake is essential. Pregnancy (only if essential), lactation. See SPC. C Amphotericin B inj. and K+ depleting agents, anticholinesterases, oral anticoagulants, antidiabetics, antihypertensives incl. diuretics, antitubercular drugs, cyclosporin, digitalis glycosides, oestrogens, hepatic enzyme inducers, human growth hormone, ketonconazole, nondepolarising muscle relaxants, NSAIDs, thyroid drugs, vaccines. A Fluid and electrolyte disturbances. Hypersensitivity reactions. GI, musculoskeletal, skin, eye, endocrine and neurological disorders. See SPC.
ANTI-ALLERGIC
DRUGS
14.1
recommended). A Fatigue, headache, nervousness (children). Somnolence, headache, increased appetite (adults).
PHENERGAN
NALCROM
Antihistamine (phenothiazine type). Promethazine
2MO
children. sanofi-aventis
2O
Italchimici (HCl) 25mg. Blue sug-ctd tab. marked PHENERGAN
Mast cell stabiliser. Cromoglycate (Na+) 100mg. Clear hard cap. containing white powder and marked Sodium Cromoglicate 100mg. 100, A15.92. S Food allergy. P 2, four times daily before meals. Q Under 2 years, not recommended; over 2 years, half adult dose. A Nausea, rash, joint pain.
25. 56, A1.77. S Allergic conditions. P Initially 1 at night increasing to 2-3 at night if necessary. Q Use elixir.
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 NEOCLARITYN Schering-Plough years, 5-15mg; over 5 years, 10-25mg. If 2 doses in 24 hours are required use lower amount stated. 2NO 2NO H1-antagonist. Desloratadine 5mg. Pale blue tab. ALSO PHENERGAN INJECTION Promethazine (HCl) marked with logo. 30, A10.35. 25mg/ml; amp. 10 x 1ml, A3.25. P 1 daily. Q Under 12 years, not recommended; over P 25-50mg by deep i.m. inj. or slow i.v. inj. after dilution. 12 years, same as adult. Q Under 5 years, not recommended; over 2NO 5 years, 6.25-12.5mg by deep i.m. inj. ALSO NEOCLARITYN ORAL SOLUTION B Alcohol, CNS depressants, MAOIs. Desloratadine 0.5mg/ml. 100ml, A5.98. 150ml, C Alcohol, CNS depressants, MAOIs. A9.25. A Drowsiness, impaired reactions. S Allergic rhinitis. Urticaria. Dizziness, disorientation, photosensitivity. P 10ml once daily. Extrapyramidal reactions, convulsions (high doses). Q Under 1 year, not recommended; 1-5 years, 2.5ml once daily; 6-11 years, 5ml once daily. PIRITON GSK Over 12 years, same as adult. B Severe renal insufficiency. Pregnancy, 2 lactation; not recommended.Oral solution contains Antihistamine (arylalkylamine type) sucralose and sorbitol. Chlorpheniramine maleate 4mg. Cream tab. A Fatigue, dry mouth, headache, marked Piriton AH. 30, A2.25. diarrhoea, fever, insomnia. S Allergic conditions. P 1 tab. 3 or 4 times daily. PERIACTIN MSD Q Under 6 years, not recommended; 6-12 2 years, v-1 tab. 3 or 4 times daily. D Pre-coma states. Antihistamine/5-HT antagonist. Cyproheptadine (HCl) 4mg. White scored tab. marked MSD 62. 30, B Lactation (sust.-release prep.). A1.21. Pregnancy. LORAT Rowex S Allergic disorders and pruritic C Alcohol, CNS depressants, MAOIs. A Drowsiness, impaired reactions. dermatoses. 2MO Dizziness. P 4mg-20mg daily. Antihistamine. Loratadine 10mg. White oval Q Under 2 years, not recommended; 2-6 tablets scored and marked LT 10. 7, A2.95; 30, sanofi-aventis years, 2mg; 7-14years, 4mg. Both three times daily. TELFAST A8.07. D Glaucoma, prostatic hypertrophy, S Symptomatic treatment of allergic 2MO bladder neck obstruction, urinary retention, rhinitis and chronic idiopathic urticaria. Antihistamine (piperidine type). Fexofenadine pyloroduodenal obstruction, stenosing peptic P 1 once daily. Severe liver impairment: (HCl) 120mg peach cap.-shaped film-ctd tab. 30, ulcer, elderly debilitated patients, lactation, Admin. every other day. A9.35. neonates, acute asthma attack. Q Under 2 years, not recommended. 2-12 S Seasonal allergic rhinitis. B Bronchial asthma, pregnancy, raised years: R30kg, 10mg not appropriate; q30kg or P 1 daily. intraocular pressure, hyperthyroidism, CVD, over 12 years, as per adults. Q Not recommended. hypertension, young childrenq2 years. B Caution: Severe hepatic impairment, 2MO C Alcohol, CNS depressants, MAOIs. prostatic hypertrophy, urinary retention, ALSO TELFAST 180 Fexofenadine (HCl) 180mg A Drowsiness, impaired reactions. glaucoma. Discontinue at least 48 hrs before skin peach cap.-shaped film-ctd tab. 30, A12.16. test. Contains lactose. Pregnancy, lactation (not Anticholinergic effects, paradoxical excitation in S Chronic idiopathic urticaria. P 1 daily. PRESCRIBING NOTES ANTI-ALLERGIC DRUGS Q Not recommended. ANTIHISTAMINES act by blocking histamine receptors. They are best used prophylatically before an allergic B Pregnancy, lactation. reaction has occurred to a stimulus. They are of no use in the treatment of asthma. They can be used to relieve A Headache, nausea, dizziness, fatigue. 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.
TIRITEK ALLERGY
Gerard
2K Antihistamine. Cetirizine (diHCl) 10mg. White, circular, biconvex film-ctd tab, embossed A on one side and scored on the other. 10mg-7, A2.30. S Seasonal and perennial allergic rhinitis, chronic idiopathic urticaria. P 10mg daily. Moderate renal impairment: 5mg once daily.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
269
14.1 ANTI-ALLERGIC
ALLERGY
DRUGS
Q Under 12 years, not recommended. D Lactation. B Impaired hepatic and renal function. Pregnancy (avoid). Contains lactose. C Caution: Alcohol, CNS depressants. A Minor CNS disturbances incl. XYZAL UCB somnolence, fatigue, dizziness and headache. If affected take dose half morning and evening. 2MO H1-antagonist. Levocetirizine diHCL 5mg. White ZIRTEK UCB oval film-ctd tab. marked with a Y logo. 30, UCERAX UCB A10.04. 2MO 2NO 2MO Non-sedative antihistamine. Cetirizine (diHCl) 10mg. White oblong film-ctd scored tab. marked Nonbenzodiazepine anxiolytic. Hydroxyzine HCI ALSO XYZAL ORAL DROPS Levocetirizine diHCL Y/Y. 7, A3.59; 30, A6.10 . 25mg. White, oblong, film-ctd biconvex scored 5mg/ml. Oral drops. 20ml, A17.82. tabs. 25, A1.31. S Seasonal and perennial allergic rhinitis, S Allergic rhinitis and chronic idiopathic urticaria, senile pruritus. 2NO urticaria. Q Under 6 years, not recommended. ALSO UCERAX SYRUP Hydroxyzine HCI 10mg/5ml. 2 M O V 1 daily. Moderate renal impairment: Clear to slightly yellow syrup (2 flavours). 200ml, ALSO XYZAL SOLUTION Levocetirizine diHCL 5mg once daily. Severe renal impairment: 5mg A2.75. 0.5mg/ml. Oral solution. 200ml, A9.04. once every 2 days. S Anxiety/tension states, psychomotor P 5mg daily (1 tab or 10ml soln or 20 2 K agitation and acute stress situations e.g. minor drops). Renal impairment: Moderate (cc: 30-49ml/ surgical procedures or allergic states. Pruritus due min), 5mg once every 2 days; severe (ccQ30ml/ ALSO ZIRTEK SOLUTION Cetirizine (diHCl) 1mg/ml. to allergic conditions e.g. chronic urticaria, atopic/ min), 5mg once every 3 days. Duration: Hay fever, Banana-flavoured, sugar-free sln. 100ml, A7.20. contact dermatitis, histamine-mediated pruritus. P 5ml (spoonful) twice daily or 10ml once 3-6 weeks; short-term pollen exposure, 1 week. P Anxiety: 50mg daily in 3 doses of daily. Q 2-6 years: 2.5mg daily (oral drops/soln 12.5mg-12.5mg-25mg. More severe cases, up to Q Under 2 years, not recommended. 2-6 only), taken in 2 divided doses (2.5ml soln twice 300mg daily. Pruritus: Initially 25mg before daily or 5 drops twice daily). 6-12 years: 5mg daily years, dose based on body weight. 10kg, 1.5ml resting, then if necessary up to 25mg, 3-4 times twice daily; 15kg, 2.5ml twice daily; 20kg, 3ml (1 tab or 10ml soln or 20 drops). Under 2 years, daily. Max.: Single dose, 200mg; daily dose, twice daily; 25kg, 4ml twice daily; 30kg, 4.5ml not recommended. Renal impairment: Adjust 300mg. Hepatic dysfunction, reduce daily dose by according to body weight. twice daily. 6-12 years, 5ml twice daily. 33%. D Lactation. End-stage renal disease D Severe renal impairment (ccQ10 ml/ R Initially, half recommended dose. (Q10ml/min cc). min). Q Over 6 years: 1mg/kg up to 2mg/kg B Significant renal impairment or B Pregnancy, lactation. Tab. contain daily in divided doses. decreased hepatic function. Pregnancy (insufficient lactose. Oral drops/soln contain methyl/propyl D Pregnancy and lactation. Porphyria. data). parahydroxybenzoate. Soln contains maltitol. B Caution: Glaucoma, bladder outflow C Caution: CNS depressants (insufficient C Caution: Alcohol, other CNS obstruction, decreased GI motility, myasthenia data). depressants. gravis, dementia. Increased potential for A Minor CNS disturbances, incl. A Headache, somnolence, dry mouth, convulsions; known predisposing factor to cardiac fatigue. somnolence, fatigue, dizziness and headache. arrhythmia or concomitant treatment with ZIRTEK PLUS DECONGESTANT Novartis potentially arrhythmogenic drugs. Young children, ZADITEN elderly, moderate/severe renal impairment (reduce 2 M O UCB dose). Stop at least 5 days before allergy testing. 0K Antihistamine/mast cell stabiliser. Ketotifen Contains ethanol, sucrose. Driving or using (hydrogen fumarate) 1mg. White scored tab Antihistamine/sympathomimetic. Cetirizine HCl machines. marked ZADITEN 1. 60, A9.92. (immediate release)/ pseudoephedrine HCl C Avoid: MAOIs, alcohol. Barbiturates, 2MO (prolonged release), 5mg/120mg. White to off other CNS depressants, anticholinergics, ALSO ZADITEN CAPS Ketotifen (hydrogen white prolonged release tab. 10, A7.31. betahistine, anticholinesterases, phenytoin, fumarate) 1mg. White cap. marked CS. 56, A10.89. S Symptoms (e.g. nasal congestion, cimetidine, CYP2D6 substrates. 2MO sneezing, rhinorrhoea, nasal and ocular pruritus) associated with seasonal or perennial allergic VALLERGAN sanofi-aventis ALSO ZADITEN ORAL SOLN. Ketotifen (hydrogen rhinitis in adults and children over 12 years. fumarate) 1mg/5ml. 300ml, A10.88. 2M P 1 tab. twice daily (morning and S Allergic rhinitis and conjunctivitis. Antihistamine (phenothiazine type). Trimeprazine P 1-2mg twice daily with food. evening). Swallowed whole with liquid, without (tartrate) 7.5mg/5ml. 100ml, A3.38. Q Under 2 years, not recommended; over crunching or chewing. Duration not to exceed 2M 2 years, 1mg twice daily with food. period of symptoms; 2-3 weeks max. After D Pregnancy, lactation. ALSO VALLERGAN FORTE SYRUP Trimeprazine disappearance of nasal symptoms, continue with A B Withdraw over 2-4 weeks. Intercurrent (tartrate) 30mg/5ml. 100ml, 6.48. antihistamine alone. Moderate renal / hepatic infections should be treated with specific S Pruritus, urticaria. Short term sedation insufficiency: 1 tab. daily. antimicrobial therapy. Reactions may be impaired. Q Over 12 years, as per adults. Under 12 and pre-anaesthetic medication in children. C Alcohol, CNS depressants, oral P 30-40mg daily in divided doses. years, not recommended. hypoglycaemics, antihistamines. Q Urticaria/pruritus: 7.5-20mg (5-13ml) D hypertension, ischaemic heart disease; A Drowsiness, impaired reactions, dry daily in divided doses. Sedation: 7-12 years, 60severe renal insufficiency, incontrolled mouth, dizziness. Occasionally CNS stimulation, 90mg daily in divided doses. 3-6 years: 15-60mg hyperthyroidism, severe arrhythmias, daily in divided doses. Pre-anaesthetic medication weight gain. pheochromocytoma, elevated intraocular pressure, (2-7 years): Max. 2mg/kg. urinary retention. Pregnancy, lactation. ZIRPINE Pinewood D Coma. Lactation. B Caution: Patients q 50 years, diabetes, 2MO B History of jaundice, liver dysfunction, hyperthyroidism, tachycardia, arrhythmia, angina, blood dsycrasias. Coronary insufficiency, cardiac moderate hepatic/renal insufficiency, prostatic H1 antagonist. Cetirizine (diHCl) 10mg. White disease. Extremes of temperature. Jaundice round film-ctd tab. marked AG one side, scored on hypertrophy, urethral dysfunction, history/high risk (discontinue if occurs). Pregnancy (only if of stroke, hypercoagulability risk (inflammatory reverse. 30, A6.05; 7 (OTC, non-GMS), A3.10. essential). Long-term use. bowel disease). May act as cerebral stimulant. S Perennial and seasonal allergic rhinitis, C Drugs potentially haemotoxic (contra), Contains lactose. Driving/operating machinery. urticaria. alcohol, CNS depressants, antihypertensives, C Not recommended: MAOIs (within 2 P 1 daily. Hepatic/severe renal impairment, reduce dose to 5mg daily. anticholinergics, MAOIs, antidepressants, weeks), b-blockers, sympathomimetics, Q 6-12 years: 1/2 tab. twice daily or 1 tab. daily. Over 12 years, as per adults. D Severe renal impairment. Avoid lactation. B Significant renal impairment or decreased hepatic function. Contains lactose. Pregnancy. C Caution: CNS depressants. A Mouth dryness, somnolence.
270
analgesics, desferrixoamine. A Nasal stuffiness, dry mouth, insomnia, agitation, drowsiness, skin rashes, respiratory depression. Extrapyramidal reactions, photosensitivity, convulsions (high doses).
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
dihydroergotamine, amphetamines; vasocontrictors and other decongestants (in case of stroke or factors which could increase haemorrhagic stroke risk). Not advised in digitalised patients. Caution: Sedatives, halogenated anaesthetic agents, alcohol ingestion, CNS depressants, NSAIDs. Antacids and PPIs increase pseudoephedrine absorption, kaolin reduces absorption. Can interfere with cutaneous tests for allergies (appropriate wash out period required). A Tachycardia, dry mouth, nausea, weakness, vertigo, dizziness, headaches, drowsiness, nervousness, insomnia.
ZIRTENE
Gerard
2MO Antihistamine. Cetirizine (diHCl) 10mg. White, capsule shaped, film-ctd tab, scored and marked CZ and 10 on one side and marked G on reverse. 10mg-30, A7.16. S Seasonal and perennial allergic rhinitis, urticaria, senile pruritus. P 1 daily. Moderate renal impairment: 5mg once daily. Severe renal impairment: 5mg once every 2 days. Q Over 12 years, as per adults. D End-stage renal disease (ccQ10ml/min). Avoid pregnancy, lactation. B Significant renal impairment or decreased hepatic function. Contains lactose. C Caution: CNS depressants (insufficient data). A Minor CNS disturbances, eg. somnolence, fatigue, dizziness, headache.
ZYNOR
Teva
2MO Antihistamine. Cetirizine (diHCl) 10mg. White filmctd tab. marked CTZ 10 one side scored on reverse. 30, A7.51.
2K ALSO ZYNOR ALLERGY Cetirizine (diHCl) 10mg. 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
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).
skin conditions requiring hydrating effect. V Apply twice daily to affected area. D Acute erythroderma, acute inflammatory, oozing or infected skin lesions. Broken or inflamed skin.
EMULSIDERM EMOLLIENT
Dermal
2 Emollient antiseptic. Liquid paraffin 25%,
Roche Consumer isopropyl myristate 25%, benzalkonium Cl 0.5%;
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
ALSO ITCH RELIEF CREAM FROM E45 Lauromacrogols 3%, urea 5%. Cream. 50g, A3.47.
Alliance S Pruritus, eczema, dermatitis and scaling
2
CALDEASE
2
emulsion. 300ml, A7.99; 1l, A18.89. S As an adjunct in the management of dry skin, by rehydration with antisepsis. V Add 7-30ml to bath of warm water and soak for 5-10 mins., or rub small amount into skin.
EUCERIN INTENSIVE 10%
Beiersdorf
2 Hydrating/keratolytic agent. Urea 10%. Cutaneous emulsion. 250ml, A8.52.
Galderma S Ichthyosis, xeroderma (especially in the
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.
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.
DERMAMIST DRY SKIN SPRAY
EURAX
2
Novartis Consumer
Alliance 2
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
HYDROMOL BATH AND SHOWER EMOLLIENT
Alliance
2K Emollient. Light liquid paraffin 37.80%, isopropyl
Schering-Plough myristate 13%, iso-octyl stearate 15.95%, laureth-3
2 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
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.
11.25%, macrogol-7 glycerol cocoate 22%. Clear, 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
Goldshield
Reckitt Benckiser 2
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, itching, chapped skin, nappy soreness, sunburn and detergent hands. Apply two or three times 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.
MORHULIN
Actavis
2K Emollient. Cod liver oil 11.4% w/w, zinc oxide 38%
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
271
15.2 ANTI-INFECTIVE
DERMATOLOGY
TOPICAL SKIN PREPARATIONS
w/w. Oint. 50g, A2.65. S Management of superficial trauma V Apply to the affected area as required. B Contains wool fat - may cause contact dermatitis. A Rarely, rash.
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.
2K
Herpes-specific enzyme inhibitor. Aciclovir 5%. White cream. 2g tube, A4.10. S Treatment of cold sores. V Apply 5 times daily at 4 hour intervals for 5 days. Continue for further 5 days if healing not complete. OILATUM EMOLLIENT Stiefel B Not for use on mucous membranes ORABASE BMS (mouth, eye, vagina). Consider oral dosing in 2 severely immune-compromised patients. Pregnancy 2 Emollient. Acetylated wool alcohols 5%, liquid (only if benefit outweighs risk), lactation. paraffin 63.4%. Liquid. 150ml, A3.45; 250ml, Skin protectant. Carmellose Na+, pectin and A4.55; 500ml, A7.12. gelatin, equal parts in Plastibase. Oint. 30g, A1.89. A Transient burning or stinging following application. Mild drying or flaking of the skin. S Contact dermatitis, atopic dermatitis, S Protection for lesions of oral mucosa Erythema and itching. Rarely contact dermatitis. senile pruritus, ichthyosis and related dry skin and moist body surfaces. V Cover the affected area with a thin film; conditions. BACTROBAN GSK do not rub in. P Add 1-3 capfuls to bath and soak for 2NO 10-20 mins. or apply small amount directly to wet R.B.C. Rybar Topical broad-spectrum antibiotic. Mupirocin 2%. skin, rub in, then rinse and dry. Q Infants, add v -2 capfuls to wash-basin Oint. 15g, A4.47. 2 and apply over entire body; others, same as adult. Antipruritic. Antazoline (HCl) 1.8%, calamine 8%, S Acute primary bacterial skin infections 2 e.g. impetigo and folliculitis. cetrimide 0.5% in emollient base. Cream. 25g, V Apply to affected area up to three ALSO OILATUM CREAM Light liquid paraffin 6%, A1.41. white soft paraffin 15%. Cream. 40g, A2.36. S Sunburn, insect bites, allergic or pruritic times daily. B Avoid eyes. Intranasal use. Pregnancy skin conditions. V Apply after washing and as required. V Apply every three hours or as required. and lactation. 2 Repeat once after 10 mins. to intensify relief. ALSO OILATUM JUNIOR Light liquid paraffin CALDESENE Clonmel 63.4%. Liquid. 150ml, A3.45; 300ml, A6.48; 350ml SPRILON Smith & Nephew 2 A pump pack, 5.48. Antifungal/antibacterial powder. Ca++ P Add 1-3 capfuls to bath; soak for 10-20 2 undecylenate 10% powder. 55g, A3.21. mins. pat dry. Barrier spray. Barrier Spray. Dimethicone 1.04%, S Nappy rash, prickly heat and chafing. Q Infants, add v-2 capfuls to basin of zinc oxide 12.5%. Aerosol. 115g-1, A4.24. water; apply over entire body and pat dry; others, S Protection of skin from faeces and CANAZOLE Pinewood same as adult. urine. Eczema, leg ulcers, spontaneous fissures, 2 pressure sores. 2OY V Spray from 20cm for 2-3 secs. Imidazole antifungal. Clotrimazole 1%. Smooth ALSO OILATUM EMOLLIENT SHOWER GEL Liquid white cream. 20g, A4.48 (20g not GMS paraffin 70%. Gel. 150g, A4.57. VASOGEN Ocean reimbursable); 50g, A4.00. V Apply to wet skin, massage in, then S Fungal skin infections due to candida, 2O rinse and dry. most commonly Candida albicans eg. vaginal 2 Emollient. Dimethicone 20%, zinc oxide 7.5%, discharge and nappy rash. Dermatophytoses eg. calamine 1.5%. Cream. 50g, 71c; 100g, A1.20. ALSO OILATUM JUNIOR FLARE-UP Light liquid ringworm and tinea pedis (athletes foot). S Barrier cream in dermatoses, pruritus, paraffin 52.5%, benzalkonium Cl 6%, triclosan Commensal yeast infections eg. Pityriasis versicolor colostomies, ileostomies, nappy rash, eczema, 2%. Colour- and fragrance-free bath oil. 150ml, (tinea versicolor). A4.19. bedsores. P Apply thinly and evenly to affected area S Infected eczemas and eczemas at risk of V Rub in gently, apply as required. twice daily. Duration at least 1 month for infection. 15.2 A NTI INFECTIVE TOPICAL SKIN dermatophyte infections and dermal Candidal Q Over 6 months, 1 capful to 10cm bath. infections; 2 weeks for Tinea versicolor. Soak for 15 mins. and pat skin dry. Use once daily. PREPARATIONS B Treat male partner to avoid recurrence 2 Rowex of vaginal candidiasis. Cetostearyl alcohol (local ALSO OILATUM PLUS Light liquid paraffin 52.5%, ACIC CREAM skin reactions). Pregnancy (avoid, especially first trimester). PRESCRIBING NOTES C Latex contraceptives; use alternative EMOLLIENTS AND OTHER SKIN PREPARATIONS precautions for at least five days after. 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.
272
CANESTEN CREAM
Bayer HealthCare
2OY Imidazole antifungal. Clotrimazole 1%. Cream. 20g, A4.51 (trade price, non-GMS); 50g, A3.96. S Fungal and Gram-positive bacterial infections of the skin incl. candidal nappy rash. V Apply sparingly 2 or 3 times daily until 2 weeks after apparent cure. A Local mild burning or irritation.
DAKTARIN
McNeil Healthcare
2O Imidazole antifungal. Miconazole nitrate 2%, cream. 30g, A2.60.
2O ALSO DAKTARIN POWDER Miconazole nitrate 2%; dusting powder. 20g, A1.70. S Topical treatment of fungal infections of the skin and secondary infections due to gram-
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
SKIN PREPARATIONS
15.2
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 FUCIDIN LEO Pharma versicolor) weeks. DESENEX Clonmel 2 N O Q Not recommended. 2 Antibacterial. Fusidic acid 2%. Cream. 15g, A3.43; 2 M ALSO LAMISIL AT CREAM Terbinafine (HCl) 1%. 30g, A5.79. Antifungal. Zinc undecenoate 20% undecenoic 7.5g, A4.62. acid 2%. Powder. 55g, A3.84. 2NO S Tinea pedis (athlete’s foot) and tinea S Athlete’s foot. ALSO FUCIDIN OINTMENT Sodium fusidate 2%. cruris (dhobie itch/jock itch) caused by P Dust hosiery and shoes. Use as required. 15g, A2.81; 30g, A4.75. Trichophyton and Epidermophyton floccosum. Q Under 2 years, not recommended. S Bacterial skin infections. P Massage into affected area once or 2 V Apply three or four times daily. Less twice daily for 1 (tinea pedis) or 1-2 (tinea cruris) frequent application if dressing used. ALSO DESENEX OINTMENT Zinc undecenoate weeks. B Avoid use in or near eye (oint). 20%, undecenoic acid 5%. Oint. 30g, A2.70. Q Under 16 years, not recommended. Pregnancy (only if essential). P Use as required. 2 N Q Under 2 years, not recommended. FUNGASIL Clonmel ALSO LAMISIL ONCE Terbinafine (HCl) 1%. Sln. B Nail or scalp infections. 4g-A8.79. 2MO S Tinea pedis (athlete’s foot). DRAPOLENE Chefaro Antifungal allylamine. Terbinafine (HCI) 10mg/g. P Apply once on both feet (even if lesions Cream. 7.5 g, A2.06. 2 only visible on one foot) and do not wash for 24h. S Fungal infections of the skin, caused by Antiseptic. Benzalkonium Cl 0.01%, cetrimide Q Under 18 years, not recommended. Trichophyton, Microsporum canis and 0.2%; cream. 100g, A3.16; 200g, A4.53. D Lactation, pregnancy (unless benefits Epidermophyton floccosum. Yeast infections of the S Napkin dermatitis, minor burns and outweigh risks). skin, principally caused by the genus Candida. wounds. Pityriasis (tinea) versicolor caused by Pityrosporum V Apply twice daily or at each nappy LANAFINE 1% CREAM Niche orbiculare. change. P Apply to affected skin and surrounding 2 M O Allylamine antifungal. Terbinafine (as HCl) 10mg FLAMAZINE Smith & Nephew area. Tinea pedis/cruris/corporis: Once daily for 1 per 1g. White cream. 15g, A3.31; 30g, A6.95. week. Cutaneous candidiasis: Once daily for 1-2 2N weeks. Pityriasis versicolor: Once or twice daily for S Fungal infections of the skin caused by Antibacterial. Silver sulphadiazine 1%. Cream. Trichophyton, Microsporum canis, Epidermophyton 2 weeks. If no improvement after 2 weeks, verify (GMS) 50g, A5.18; 250g, A13.89; 500g, A24.60. floccosum. Yeast infections of the skin, principally diagnosis. S Burns, infected wounds, infected leg those caused by Candida. Pityriasis (tinea) Q Under 12 years, not recommended. D Pregnancy, lactation; not recommended. versicolor due to Pityrosporum orbiculare. PRESCRIBING NOTES 2OY B External use only. Avoid contact with ANTI-INFECTIVE SKIN PREPARATIONS ALSO LANAFINE AFR 1% CREAM Terbinafine (as eyes. Contains cetyl alcohol and cetostearyl ANTIBIOTICS: To minimise resistance it is HCl) 10mg per 1g. White cream. 7.5g, A2.13. alcohol. advisable only to use topical antibacterials, S Tinea pedis, tinea cruris caused by A Application site reactions. Trichophyton and Epidermophyton floccosum. which are not also administered systemically. GRANEODIN BMS P Apply once or twice daily to affected Some can cause sensitivity (neomycin) and some skin and surrounding area. Tinea pedis: 1 week. can have systemic side-effects (ototoxicity with 2NO Tinea cruris, Cutaneous candidiasis, Pityriasis aminogycoside). Mupirocin is not related to any Aminoglycoside. Neomycin sulph. 0.25%, versicolor: 2 weeks. If no improvement after 2 other antibacterial in use and is effective in gramicidin 0.025%; oint. 25g, A1.71. weeks, verify diagnosis. gram-positive skin infections. Silver S Bacterial infections incl. impetigo and Q Not recommended. sycosis barbae. sulphadiazine is indicated in the treatment of D Pregnancy (unless benefit outweighs V Apply two to four times daily. infected burns. Tetracyclines and risk), lactation. D Fungal or viral infections; deep-seated aminoglycosides are both broad spectrum and B External use only. infections. active topically for a range of infections. A Application site reactions. B Avoid use of dressings. Large areas of ANTIFUNGALS: Fungal infections can be damaged skin. LOCERYL Galderma treated effectively with topical preparations A Ototoxicity, sensitisation. positive bacteria (staphylococcus and streptococcus spp.). V Apply once or twice daily to affected areas until lesions have completely healed. Powder can be used seperately or with cream. B If reaction suggesting irritation occurs, treatment should be discontinued. Avoid contact with eyes.
unless there is a nail or scalp infection or the affected area is large, in which case systemic treatment may be indicated. Tinea infections can be treated with imidazoles (e.g. clotrimoxazole, econazole, miconazole, sulconazole) or other antifungals including terbinafine, amorolfine and the undecenoates. Benzoic acid preparations are also effective but less acceptable to patients. Imidazole antifungals and nystatin can be used 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.
ulcers, pressure sores. P Apply in layer 3-5mm thick. Change dressing 3 times weekly for ulcers; daily for burns. Q Up to 3 months, not recommended; other, as for adult. D Pregnancy. B Impaired renal or hepatic function.
2MO
KETOZOL
Rowex Antimycotic. Amorolfine (HCl) 5%. Nail lacquer
Ketoconazole 2%. Clear reddish shampoo. 120ml, A6.59. S Seborrhoeic dermatitis of the scalp in adults. P Wash affected areas with shampoo, rinse after 3-5 minutes. Repeat twice weekly for 24 weeks. Prophylaxis, once every 1-2 weeks. B Avoid eyes. A Skin irritation, dry fragile hair, slight hair loss.
soln. 5ml, A24.15. S Onychomycoses caused by dermatophytes, yeasts and moulds. P Apply to affected nail once weekly. Twice weekly applications may be beneficial in some cases. Q Not recommended. D Hypersensitivity. Pregnancy, lactation (unless considered appropriate by physician). B Avoid contact with eyes, ears and mucous membranes. A Rarely pruritus, transient burning.
LAMISIL
MYCIL
2KO
Novartis Consumer
Reckitt Benckiser
2MO
2
Allyamine antifungal. Terbinafine (HCl) 1%.
Antifungal. Tolnaftate 1%, chlorhexidine (HCl)
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
273
15.3 SCABIES
DERMATOLOGY
TREATMENTS
0.25%. Powder. 55g, A3.80. S Athleteâ&#x20AC;&#x2122;s foot. V Apply night and morning, continue treatment for at least one week after infection has cleared.
2K
ALSO SAVLON ANTISEPTIC LIQUID Cetrimide 2.25%, chlorhexidine gluconate 0.225%. Concentrate for cutaneous solution. 250ml, A1.52; 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 morning. Continue treatment for at least a week water before use. after infection has cleared. 2K 2 ALSO SAVLON DRY ANTISEPTIC Povidone iodine ALSO MYCIL SPRAY Tolnaftate 1%. 150ml, A3.80. 1.14% (5% available iodine content in the V Apply night and morning.Continue powder). Pressurised cutaneous spray powder. treatment for at least one week after infection Orange/brown micronised powder and has cleared. propellants. A3.40. S Topical prophylaxis and treatment of MYCOSTATIN BMS superficial infections or injuries of skin. 2OY Q Not recommended for regular use in neonates. Antifungal. Nystatin 100 000 units/g. Cream. 15g, A1.58. V Apply to affected area by spraying from 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). NIZORAL McNeil Healthcare B Spray: Iodine absorption may interfere with thyroid function tests. Application to 2O extensive areas of broken skin may lead to Imidazole antifungal. Ketoconazole 2%; white, excessive absorption of iodine. odourless cream. 30g, A4.41. C Spray: Avoid lithium. S Dermatophyte infections of skin incl. A Spray: Skin irritation. Tinea spp., Trichophyton spp., Microsporum spp. and Epidermophyton spp. Cutaneous candidosis TROSYL Pfizer and pityriasis versicolor. V Apply once or twice daily. 2MO 2O Imidazole antifungal. Tioconazole 28%; Clear, pale ALSO NIZORAL SHAMPOO Ketoconazole 2%. Pink yellow soln. for topical application. 12ml with viscous shampoo. 120ml, A6.60. applicator, A29.89. S Seborrhoeic dermatitis of the scalp and S Topical treatment of nail infections due body and pityriasis versicolor. to susceptible fungi (dermatophytes, yeasts). V Wash affected area and leave for 3-5 V Apply to affected nails and surrounding min. before rinsing. Treatment should be repeated skin 12 hourly. Duration of treatment 6-12 months twice weekly for 2-4 weeks. Prophylaxis, use once according to response. every 1-2 weeks. D Pregnancy, lactation. B Avoid eyes. B Not for opthalmic use. C To prevent rebound effect after A Local iritation. stopping prolonged treatment with topical corticosteroids, continue applying steroid and VIRALIEF Clonmel reduce over 2-3 weeks. 2K A Skin irritation. Herpes-specific enzyme inhibitor. Aciclovir 5% 2g, A3.74. POLYFAX Teva S Herpes simplex infections of the skin. 2NO V Apply 5 times daily at 4 hour intervals Peptide antibiotics. Polymyxin B sulph. 10,000 for 5 days. Continue for further 5 days if healing units, bacitracin zinc 500 units per g; oint. 20g, not complete. A7.63. B Not for use in eyes. Pregnancy, S Skin infections. lactation. V Apply sparingly two or more times A Transient burning or stinging following daily. application. Erthema and flaking with tropical use. B Large open wounds. Rarely contact dermatitis. A Nephrotoxicity, rarely allergic reactions. 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. S Cleansing and prevention of infection of all types of lesions incl. minor skin disorders or blisters and minor burns and wounds. V Apply to affected area.
274
DERBAC-M
SSL Healthcare
2KO 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.
EURAX
Novartis Consumer
2 Scabicide. Crotamiton 10% lotion and cream. Lotion-100ml, A3.83; Cream-30g, A3.09; 100g, 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
Chefaro
2 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.
LYCLEAR DERMAL CREAM
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. GSK A Burning, stinging.
ZOVIRAX
SAVLON ANTISEPTIC CREAM
15.3 SCABIES TREATMENTS
2NO 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.
QUELLADA M
Stafford-Miller
2O Pediculicide/scabicide. Malathion 0.5%; liquid. 200ml, A5.05. S Head and pubic lice. Scabies. Head lice, apply liberally and leave for 12 hours then shampoo hair. Pubic lice, apply to all areas incl. beard and moustache. Leave for 1-12 hours before washing off. Scabies, apply to whole body except
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
VIRALIEF
DELTASORALEN
Clonmel 2
2K Herpes-specific enzyme inhibitor. Aciclovir 5% 2g, A3.74. 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.
15.4 PSORIASIS AND ECZEMA PREPARATIONS
CAPASAL SHAMPOO
Dermal
2K 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 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.
COCOIS
UCB
2O 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. PRESCRIBING NOTES SCABIES Scabies is caused by the mite Sarcoptes scabei, and can be treated with benzyl benzoate, malathion, permethrin and crotamiton. All members of the household should be treated together. Treatment should be applied to the whole body. Patients should not wash their hands as it will require reapplication. Itching associated with scabies can persist for some weeks after infestation eliminated; treatment with crotamiton can be useful in controlling itching. Head and pubic lice, Pediculus humanus capitis are treated with carbaryl, malathion, permethrin and phenothrin. Resistance is 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.
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, diabetes mellitus, lupus erythematosus or porphyria. B Concurrent admin. of drugs which cause photosensitisation. Protect eyes from U.V. A Slight nausea _ relieved by milk.
DITHROCREAM
DOVONEX
LEO Pharma
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 Dermal ALSO DOVONEX SCALP SOLUTION Calcipotriol
2MO Antipsoriatic. Dithranol 0.1%, 0.25%; cream. 0.1%50g, A4.71; 0.25%-50g, A5.05. S Sub-acute and chronic psoriasis.
2MO ALSO DITHROCREAM FORTE Dithranol 0.5%; cream. 50g, A5.81. V Start treatment with 0.1% cream. Increase strength according to tolerance and response. For short contact use, apply once daily and wash off after v _1 hour. Alternatively, apply at night and wash off in the morning.
2MO ALSO DITHROCREAM HP 1% Dithranol 1%; cream. 50g, A6.77.
2MO
15.4
genitals, avoid long-term use. Pregnancy, lactation (do not use on breast). C Other steroids (avoid). Delta A Pruritus, rash, local reactions.
B Avoid contact with eyes, mucous membranes, acutely inflammed areas.
face and scalp and leave for 24 hours before washing off. off during the 24 hours. B Infants under 6 months. Avoid eyes.
ECZEMA PREPARATIONS
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 use on face. Severe renal failure or severe hepatic 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. LEO Pharma A Local irritation.
ALSO DITHROCREAM 2% Dithranol 2%; cream. 50g, A8.47. V Apply as above but usually only for 30 mins._1 hour before washing off. D Acute psoriasis. A Skin irritation, hypersensitivity.
DOVOBET 2NO
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 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
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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
275
15.4 PSORIASIS
DERMATOLOGY
AND ECZEMA PREPARATIONS
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.
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/ rectal areas. Pregnancy, lactation. A Skin irritation, photosensitivity.
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 HUMIRA Abbott reactivation, pancytopenia reported. C Increased antibody formation and 2NT Humira clearance when admin. without Tumour necrosis factor (TNF) antagonist. Adalimumab 40mg. Soln for inj in 0.8-ml pre-filled methotrexate. Live vaccines, anakinra (not recommended), immunosupressants (caution). pen or pre-filled syringe (2 per pack). Price on A Inj. site reaction, upper and lower request. respiratory infections, viral/bacterial infections, S Moderate to severe chronic plaque psoriasis where response to other systemic therapy candidiasis, dizziness, headache, neurological including cyclosporine, methotrexate or PUVA was sensation disorders. Cough, nasopharyngeal pain, EXOREX Forest diarrhoea, abdominal pain, stomatitis and mouth inadequate. ulceration, nausea, hepatic enzymes increased, 2KO P 80mg at week 0, followed by 40mg at rash, pruritus, dermatitis, eczema, hair loss, Antipsoriatic. Coal tar 5%. Alcoholic extract, week 1; and then 40mg once fortnightly via SC musculoskeletal pain, pyrexia, fatigue. cutaneous emulsion. 100ml, A13.65, 250ml, injection. A27.30. Q Under 18 years, not recommended. METED Alliance S Treatment of psoriasis of skin and scalp. D Active tuberculosis, other severe 2 P Apply thin layer 2 or 3 times daily. infections (sepsis), uncontrolled / opportunistic Antiseptic/keratolytic. Salicylic acid 3%, colloidal R Dilute lotion with few drops boiled infections. Moderate to severe HF. Pregnancy, sulphur 5%; liquid. 120ml, A5.28. water and apply as for adults. lactation. S Seborrhoeic dermatitis, psoriasis of the scalp, dandruff. PRESCRIBING NOTES P Use as shampoo at least twice weekly. PSORIASIS A Irritation. 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 skinâ&#x20AC;&#x2122;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 treatmentâ&#x20AC;&#x2122;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
276
NEORAL
Novartis
2MT Fungal metabolite immunosuppressant. Cyclosporin 25mg blue-grey oval cap., 50mg yellow-white oblong cap.; 100mg blue-grey oblong cap. All marked with S in a triangle and cap. strength. 25mg-30, A25.84; 50mg-30, A50.60; 100mg-30, A96.03.
2MT ALSO NEORAL ORAL SOLUTION Cyclosporin 100mg/ml. Oral soln. 50ml, A143.89. S Severe psoriasis or severe atopic dermatitis where standard therapy is ineffective or inappropriate. P Psoriasis, initially 1.25mg/kg twice daily. If necessary after 1 month, increase gradually up to max. 5mg/kg daily in two divided doses. Discontinue therapy if ineffective within 6 weeks on 5mg/kg daily. An initial dose of 5mg/kg daily in two divided doses when rapid improvement required. Dermatitis, 1.25-2.5mg/kg twice daily for max. 8 weeks. An initial dose of 5mg/kg per day in two divided doses may be used when rapid improvement is required. Q Not recommended. D Impaired renal function, uncontrolled hypertension, uncontrolled infection. Malignancy other than of the skin. B Only use under specialist supervision. PUVA or UVB therapy. Closely monitor renal and liver function, BP and serum lipids, serum K+. Hyperkalaemia, hyperuricaemia. Skin malignancy. Active herpes simplex infections should be cleared before treatment. Advise patients to avoid sunbathing. Pregnancy, lactation. Not 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,
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
nephrotoxic drugs, oral contraceptives, propafenone, prednisolone, methylprednisolone, 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.
NEOTIGASON
Actavis
benefit outweighs risk).
PENTRAX
15.4
PSORIDERM BATH EMULSION 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
ECZEMA PREPARATIONS
Dermal
2O Antipsoriatic. Coal tar 40%; bath emulsion. 200ml, A3.49. S Sub-acute and chronic psoriasis.
2O ALSO PSORIDERM CREAM Coal tar 6%, lecithin 0.4%. 225ml, A3.96. V Rub in twice daily.
Stiefel 2
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.
ALSO PSORIDERM SCALP LOTION Coal tar 2.5%, lecithin 0.3%. 250ml, A8.35. V Wet hair and use as a shampoo. D Acute psoriasis. A Skin irritation, photosensitivity.
REMICADE
Schering-Plough
2N
Monoclonal antibody. Infliximab 100mg. Powder for conc. for soln in vial. 1, A690.43. S Moderate-severe plaque psoriasis in adults failing to respond/with a contraindication/ Topical immunomodulator. Tacrolimus intolerant to other systemic therapy incl. monohydrate 0.03%, 0.1%; oint. 0.03%-30g, A27.54; 60g, A52.32; 0.1%-30g, A30.60; 60g, cyclosporine, methotrexate, PUVA. A58.19. P 5mg/kg IV inf. over 2 hrs followed by S Treatment of moderate to severe atopic 5mg/kg inf. at 2 and 6 weeks, then every 8 weeks. If no response after 14 weeks, discontinue. dermatitis in adults who are not adequately Q Under 17 years, not recommended. responsive to or are intolerant of conventional D TB (must be screened for active/ therapies (e.g. topical corticosteroids). inactive), severe infections eg. sepsis, abscesses. Maintenance treatment to prevent flares and to Moderate/severe HF. Women should use adequate prolong flare-free intervals in patients contraception and should not breastfeed during experiencing a high frequency of disease treatment and within 6 months of last dose. exacerbations (q 4 or more times per year) who B Monitor for acute inf. reactions during/ have had an initial response to a max of 6 weeks within a few hours of inf. If necessary interrupt treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected). immediately. Ensure emergency equip. and treatment available. Monitor patients retreated P Treatment: Start treatment with 0.1% after a long period. Caution: Chronic infection or twice a day until clearance of the lesion. If symptoms recur, restart twice daily treatment with recurrent infections. Discontinue if patient 0.1%. Consider reducing frequency or strength to develops symptoms of lupus-like syndrome, antinuclear antibodies or serious infection. Elderly, 0.03% if clinical condition allows. Consider other hepatic impairment, mild heart failure. Increased treatment options if no signs of improvement risk of malignancies (caution with heavy smokers, after 2 weeks. Maintenance: Apply 0.1% to commonly affected areas once a day, twice weekly history of malignancy). UC patients: Regularly screen for dysplasia. Crohn’s: Rare cases of leaving 2-3 days between applications. If flare reoccurs, re-initiate twice daily treatment. Review hepatosplenic T-cell lymphoma reported. Paediatric Crohn’s: If possible, bring up to date treatment after 12 months. Q r2 years:Treatment: 0.03% twice a day with all vaccinations before initiating Remicade therapy. for up to 3 weeks. Thereafter reduce to once a C Anakinra, live vaccines (not day until clearance of lesion. Maintenance: Apply recommended). 0.03% to commonly affected areas once a day, A Viral infection, serum sickness-like twice weekly leaving 2-3 days between reactions, headache, vertigo, flushing, RTIs, applications. If flare reoccurs, re-initiate twice daily NEUTROGENA T-GEL dyspnoea, sinusitis, GI disorders, dyspepsia, skin/SC treatment. Review treatment after 12 months. r tissue disorders, fatigue, chest pain, fever, elevated SHAMPOO McNeil Healthcare 16 years, as per adults. hepatic transaminases, inf. reactions. 2K D Hypersensitivity to macrolides. Pregnancy, lactation. Patients with genetic Keratolytic/antipruritic/antiseptic. Refined coal tar SANDIMMUN Novartis epidermal barrier defects. Occlusive dressings. 5mg/ml. Shampoo. 125ml, A3.49; 250ml, A5.59. 2MT S Symptomatic treatment of dandruff and Congenital or acquired immunodeficiencies, Fungal metabolite immunosuppressant. immunosuppression. seborrhoeic dermatitis of the scalp. Cyclosporin 25mg pale pink oval cap., 50mg P Cutaneous use only. Apply liberally and B Protect from sunlight or UV light. yellow oblong cap.; 100mg dusky pink oblong cap. Concomitant use with other topical preparation. massage into wet scalp, leave for several min. 25mg-30, A29.01. 50mg-30, A53.77. 100mg-30, Hepatic failure, erythroderma. Clinical infections Rinse, repeat application and rinse thoroughly. A105.50. Use once or twice weekly for 4 weeks. Treatment should be cleared before use. Malignancies (incl. 2NT cutaneous and other types of lymphoma, skin q 4 weeks, under medical supervision. cancers) reported. ALSO SANDIMMUN ORAL SOLUTION Cyclosporin Q Under 12 years, contra. 100mg/ml. Oral soln. 50ml, A129.09. D Acutely inflamed or broken skin. Use in C Caution: Vaccination. A Application site reactions (e.g. burning, S Severe psoriasis or severe atropic children under 12 years. pruritus, irritation, pain), paraesthesias, dermatitis where standard therapy is ineffective or B If irritation develops, discontinue and in appropriate. consult physician. Avoid contact with eyes. Rarely, dysaesthesias, alcohol intolerance (facial flushing or skin irritation), folliculitis, herpes simplex V See lit. temporary discoloration of blond, bleached or D Hypersensitivity to cyclosporin. tinted hair may occur. Pregnancy, lactation (only if infections.
2NO
PROTOPIC
Vitamin A derivative. Acitretin 10mg; 25mg. Resp. brown cap/white body or brown cap/yellow body. Both with actavis logo on cap and strength on body. 10mg-60, A31.35. 25mg-60, A72.80. S Severe, extensive refractory psoriasis; palmo-plantar pustular psoriasis; severe congenital ichthyosis; severe Darier’s disease; severe lichen planus. P Initially 25-30mg daily with food, adjusting according to response. Max. 75mg daily. Maintenance, 25-50mg daily. Q 0.5mg/kg daily. Max. 1mg/kg daily for a limited time only. D Pregnancy, lactation. Renal or hepatic impairment. Elevated blood lipid values. B Teratogenic. Contraceptive measures must be taken during and for at least 2 years after treatment. Avoid blood donation for min. 1 year after treatment. Diabetes. Monitor liver function and serum cholesterol and triglycerides. Bone changes on long term therapy. Contains glucose. C Tetracyclines, high dose vit. A, methotrexate. A Paronychia, headache, dry eyes, flushing, nasal dryness, epistaxis, rhinitis, dry mouth, gingivitis, stomatisis, GI disorder, dry skin, erythema, pruritus, alopecia, skin exfoliation, skin atrophy, skin fragility, sticky skin, dermatitis, abnormal hair texture, onychoclasis, hyperhydrosis, arthralgia, myalgia, oedema peripheral, increased blood cholesterol, increased triglycerides, abnormal liver function test.
2NO
Astellas
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
277
15.5 ACNE
DERMATOLOGY
AND ROSACEA PREPARATIONS
Uncontrolled hypertension, uncontrolled infection. Malignancy. B Monitor renal and liver function, BP and serum lipids. Hyperkalaemia, hyperuricaemia. Pregnancy, lactation. C Systemic antibiotics, live vaccines, phenytoin, ketoconazole, fluconazole, 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.
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.
STIEPROX
Stiefel
2MO
Broad spectrum antifungal. Ciclopiroxolamine 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. SELSUN Chattem Q Not recommended. B Avoid contact with eyes. Pregnancy, 2 lactation. Antidandruff agent. Selenium sulphide 2.5%. A Rarely skin irritation. Shampoo. 50ml x 6, A11.25; 100ml x6, A16.90. S Dandruff and seborrhoea capitis. XAMIOL LEO Pharma Q Under 5 years, not recommended. 2NO V Massage and leave for 2-3 mins. Use twice weekly for 2 weeks, then weekly for next 2 Antipsoriatic (vit. D derivative)/potent steroid. weeks. Calcipotriol (monohydrate) 50mcg/g, D Pregnancy (1st trim.), lactation. betamethasone (dipropionate) 0.5mg/g. Almost B Do not use within 2 days of perming or clear, colourless to slightly off-white gel. 60g, A46.20. dyeing. Discontinue if irritation occurs. S Topical treatment of scalp psoriasis. SILKIS Galderma P Apply to affected area once daily for 4 weeks. Repeat treatment under supervision. 2NO Vit. D analogue. Calcitriol 3mcg per g. Oint. 100g, Q Under 18 years, not recommended. D Known disorders of calcium metabolism. A21.29. S Topical treatment of mild to moderately Viral (e.g. herpes or varicella) lesions of the skin, severe plaque psoriasis (psoriasis vulgaris) with up fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to to 35% of body surface involvement. tuberculosis or syphilis, perioral dermatitis, P Apply to affected area twice daily, in the morning and evening before retiring and after atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, washing. It is recommended that not more than rosacea, ulcers and wounds. Guttate, 35% of body surface be exposed to daily treatment. Max. 30g per day for no more than 6 erythrodermic, exfoliative and pustular psoriasis. weeks. Severe renal insufficiency or severe hepatic Q Not recommended. disorders. D Patients on systemic treatment of Ca++ B Avoid concurrent treatment with other homeostasis, kidney or liver dysfunction, steroids on the scalp. Avoid use on more than hypercalcaemia, abnormal calcium metabolism. 30% of body surface, large areas of damaged skin, B Apply to the face with caution, avoid under occlusive dressings, mucous membranes, contact with eyes. Wash hands after application. skin folds. Increased risk of local and systemic Do not cover with occlusive dressing. Sensitivity or corticosteroid undesirable effects with long-term severe irritation. use. If lesions become secondarily infected, treat C Medications known to increase the with antimicrobiological therapy; stop treatment if serum Ca++ level, such as thiazide diuretics. infection worsens. Risk of generalised pustular Caution in patients receiving calcium suppl. or psoriasis or of rebound effects when discontinuing high doses of vit. D. treatment, continue medical supervision after A Skin irritation (reddening, itching), discontinuation. Hypercalcaemia may occur if the discontinue if severe irritation occurs. maximum weekly dose (100g) is exceeded. Avoid excessive exposure to natural or artificial sunlight. SOLARAZE Shire Contains butylated hydroxytoluene. Pregnancy, 2MO lactation. NSAID. Diclofenac Na+ 3% w/w. Gel. 25g, A20.32. A Pruritus, local reactions. S Actinic keratoses. P Apply locally to skin twice daily. Usually 15.5 ACNE AND ROSACEA PREPARATIONS 0.5g on 5cm x 5cm lesion site. Duration 60-90
278
ACNECIDE
Galderma
2K Antibacterial-keratolytic. Hydrous benzoyl peroxide equiv. benzoyl peroxide 5% w/w. Gel. 60g, A5.99. S Acne vulgaris. V Apply once or twice daily. D Pregnancy, lactation (unless essential). B Avoid eyes, mucous membranes. Do not apply to damaged skin. Avoid sunlight, UV. C Drugs with desquamative, irritant and drying effects. A Transient irritation and peeling.
ACNISAL
Alliance
2 Antibacterial-keratolytic. Salicylic acid 2%. Soln. 177ml, A5.66. S Acne. P Lather with warm water, massage into skin two or three times daily, then rinse. A Irritation, salicylism.
BREVOXYL
Stiefel
2 Anti-bacterial-keratolytic. Benzoyl peroxide 4%; cream. 40g, A4.30. S Mild to moderate acne. P Wash affected area, then apply once or twice daily. Q Not recommended. B Avoid eyes, mouth and mucous membranes. A Transient irritation and peeling.
BY-MYCIN
Ergha
2NO Tetracycline. Doxycycline (hyclate) 50mg. Opaque pale green/white cap. 28, A5.80. S Acne vulgaris. P 1 daily with food or fluid for a min. of 6 weeks. 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.
DALACIN T
Pharmacia
2NO Antibiotic. Clindamycin phos. 10mg/ml. White emulsion or soln. Rollerball lotion -30ml, A7.89; 50ml, A13.15; Soln-30ml, A6.93; 50ml, A11.55. S Acne vulgaris, particularly of papular or pustular type. V Apply thin film twice daily to affected area. D Lincomycin sensitivity. B Avoid eyes and mucous membranes. Pregnancy. C Keratolytics. A Dry skin, dermatitis, folliculitis (soln.). Diarrhoea or colitis (discontinue immediately).
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 DIANETTE
ACNE Bayer Schering
2MO Oestrogen/progestogen. Ethinyloestradiol 35mcg, cyproterone acetate 2mg; beige sug-ctd biconvex tab. 21, A5.58. S Severe acne vulgaris in females; contraception for females with severe acne vulgaris. P Acne: males, not recommended. Females, 1 daily. First course begins on first day of menses, with seven day interval between 21 day courses. Q Not recommended. D As for combined oral contraceptives. See SPC.
AND ROSACEA PREPARATIONS
Q Not recommended. D Severe acne, broken skin, eczema. Pregnancy (unless essential); adequate contraception must be used. B Avoid eyes, lips, angle of nose, mucous membranes, excessive exposure to sunlight. Lactation. C Retinoids. A Dry skin, skin irritation, skin burning sensation, erythema. Reduce application or withdraw if severe.
DUAC ONCE DAILY
15.5
risk). C Avoid topical acne products containing vit. A. Caution: Other topical antibiotics, medicated or abrasive soaps/cleansers, products with strong drying effect, with alcohol or astringents. A Erythema, peeling, dryness, burning, pruritus.
EFRACEA
Galderma
2NO Doxycycline 40mg (monohydrate). Beige, size 2
Stiefel modified-release hard cap. marked CGPI 40. 56,
2NO
Antibiotic/antibacterial. Clindamycin phosphate 1%, anhydrous benzoyl peroxide (as hydrous benzoyl peroxide) 5%. Gel. 25g, A12.92. DIFFERIN Galderma S Mild to moderate acne vulgaris, 2NO particularly inflammatory lesions. Retinoid-like. Adapalene 0.1%. Aqu. gel. 30g, P Apply once daily in the evening. A7.95. Q Under 12 years, not recommended. 2NO D Lincomycin sensitivity. Lactation. B Avoid contact with mouth, eyes, mucous ALSO DIFFERIN CREAM Adapalene 0.1%. Cream. A 30g, 7.95. membranes, abraded or eczematous skin. Caution: History of regional enteritis, ulcerative or S Mild to moderate acne vulgaris where antibiotic-associated colitis (discontinue if occurs), comedones, papules and pustules predominate. P Wash and dry affected area. Apply thin atopic patients. Minimise exposure to sun or sunlamps. Advise patients that 4-6 week treatment film once daily at bedtime. Reassess after 3 may be required. Pregnancy (if benefit outweighs months. PRESCRIBING NOTES ACNE Acne is a disease of the sebaceous hair follicle. Under normal circumstances, sebum travels up the hair 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.
A30.10 . S To reduce papulopustular lesions in adult patients with facial rosacea. P 40mg daily in morning with adequate amounts of water. Consider stopping treatment if no effect seen after 6 weeks. Assess patients 4 weeks after stopping treatment. D Infants and children up to 12 years. 2nd, 3rd trimesters of pregnancy. Known or suspected achlorhydria; surgery that bypasses or excludes duodenum. Lactation (long term use). B Must not be used to treat infections. Not for use in ocular manifestations of rosacea (ocular rosacea and/or blepharitis/meibomianitis). Caution: Predisposition to candidosis, hepatic impairment, myasthenia gravis. May occur: Oesophageal irritation / ulceration, pseudomembranous colitis. Avoid excessive sunlight or UV (discontinue if phototoxicity occurs). Discontinue if severe acute hypersensitivity reaction occurs. Contains sucrose. C Drug/food containing bi- or tri-valent ions (e.g. alum., zinc, Ca++, Mg++, iron, activated charcoal, cholestyramine, bismuth chelates); take 2-3 hrs following doxycycline. Caution: Quinapril, 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.
ISOTREX
Stiefel
2N Vitamin A derivative. Isotretinoin 0.05%; alc. gel. 30g, A10.67. S Mild to moderate acne vulgaris. P Apply sparingly once or twice daily for min. 6_8 weeks. Q Not recommended. D History, or family history of cutaneous epithelioma. Pregnancy, lactation. B Avoid eyes, mouth, mucous membranes, abraded or sun burnt skin. Avoid UV light. C Keratolytics. A Local irritation.
ISOTREXIN
Stiefel
2NO 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,
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
279
15.5 ACNE
DERMATOLOGY
AND ROSACEA PREPARATIONS
Colourless translucent gel. 60g, A11.95. S Topical treatment of mild to moderate acne vulgaris. P V Apply sparingly twice daily. Reduce to MINOCIN SA Meda once daily or alternate days, if irritation or peeling occurs. 2NO B For external use only. Avoid eyes and Antibiotic. Minocycline (HCl) 100mg. Orange/ brown sust. action cap. marked LEDERLE and 8560. mucous membranes. Pregnancy and lactation (caution). 56 (8 week Cal/Pk), A33.01. A Skin dryness or irritation. S Acne. P 1 daily swallowed whole. Stiefel Q Under 12 years, not recommended; over PANOXYL 2 12 years, same as adults. Antibacterial-keratolytic. Benzoyl peroxide 5%, D Pregnancy, lactation. 10%; alc. gel. 5%-40g, A3.14. 10%-40g, A3.50. B Hepatic impairment. S Acne vulgaris. C Antacids, mineral suppl., penicillin, V Commence treatment with lowest anticoagulants. strength. Wash, then apply once daily. A GI disturbances, allergic reactions. B Avoid eyes, mouth and mucous Superinfections. membranes. MINOSIL Pinewood A Transient irritation and peeling.
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.
2NO
2MO
abraded or sun burnt skin, build up in skin fold areas. Pregnancy, lactation. C Keratolytics. A Local irritation.
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. Q Over 12 years, as per adults. Under 12 years, not recommended. D Complete renal failure, severe liver disease. Pregnancy, lactation. B Caution: Mild to moderate hepatic dysfunction, severe renal insufficiency, myasthenia gravis, elderly. Monitor organ system function periodically (haematopoietic, renal, hepatic). Reported: Auto-immune hepatotoxicity, SLE, hyperpigmentation, tooth discolouration (childrenQ12), photosensitivity, intracranial hypertension with vision disturbances. Crossresistance between tetracyclines. Driving/using machines. C Caution: Alcohol, other hepatotoxic drugs, oral contraceptives, anticoagulants, diuretics, ergot alkaloids. Avoid penicillin. Antacids, suppl. with iron, Ca++, magn., alum., bismuth and zinc salts; take 3 hours apart. Avoid isotretinoin before, during and shortly after therapy. Urinary catecholamine tests. A Dizziness (lightheadedness).
MINOX 50
QUINODERM CREAM
Galderma
2MO Nitroimidazole antibiotic. Metronidazole 0.75%; aqu. gel. 30g, A5.49. S Acne rosacea.
Quinoderm ALSO ROZEX CREAM Metronidazole 0.75%. 30g, A5.49.
2
S Acne rosacea in dry/sensitive skin types. P Applya thin film twice daily after washing. Q Not recommended. 2 ALSO QUINODERM CREAM 5 K+ hydroxyquinoline D Pregnancy, lactation. B Avoid contact with eyes, avoid UV A sulph. 0.5%, benzoyl peroxide 5%. 50g, 3.21. exposure, history of blood dyscrasia. S Acne vulgaris, acneform eruptions, A Local irritation. folliculitis. B Avoid eyes, mouth and mucous SKINOREN 15% GEL Bayer Schering membranes. 2MO A Transient irritation and peeling. Antibacterial/keratolytic. Azelaic acid 15%. Topical RETIN-A 0.05% Janssen-Cilag gel. 30g, A8.10. S Relief of mild/moderate papular2M Vitamin A derivative. Tretinoin 0.05%; cream. 20g, pustular acne of facial area. Topical treatment of papulopustular rosacea. A14.78. P Cutaneous use only. Cleanse skin before S For the management of acne vulgaris application. Apply sparingly to affected skin areas and other keratotic conditions. twice daily (morning and evening) and massage P Apply once or twice daily. 6-8 weeks gently into the skin. Approximately 0.5g ( 2.5cm) therapy may be needed before improvement is of gel is sufficient for the entire facial area. seen. Occlusive dressing or wrappings should not be D History of cutaneous epitheliomata or used, and hands should be washed after eczema, damaged skin.Pregnancy. B Avoid excessive sunlight and use of U-V application. Q Under 12 years, not recommended. lamps. Contact with eyes, mucosa and open D Propylene glycol hypersensitivity. wounds. Lactation (caution). B External use only. Avoid contact with C Keratolytics. eyes, mouth and other mucous membranes. A Erythema, irritation. Contact dermatitis Pregnancy. Infants must not come into contact (rare). with treated skin/breast. ROACCUTANE Roche A Burning/stinging, pruritus, erythema/skin irritation, dry skin, scaling. Antibacterial/keratolytic. K+ hydroxyquinoline sulph. 0.5%, benzoyl peroxide 10%. 25g, A2.10; 50g, A3.49.
Rowex 2 N O
Vitamin A derivative. Isotretinoin 10mg, 20mg. Oval, opaque, reddish violet (10mg) or pale redviolet and white (20mg) cap. imprinted with ROA 10 or ROA 20 resp. 10mg-30, A17.08; 20mg-60, A68.31. S Cystic and conglobate acne, severe acne unresponsive to antibiotic therapy. P Initially 0.5mg/kg body-wt. daily as a single dose or in two divided doses with food for 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. NICAM GEL Dermal D Hepatic and renal impairment. 2K Pregnancy, lactation. B Exclude pregnancy before starting Topical anti-inflammatory. Nicotinamide 4%.
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.
280
ROZEX
STIEMYCIN
Stiefel
2NO Antibiotic. Erythromycin 2%; alc. soln. 50ml, A10.44. S Acne. V Apply twice daily after washing. A Local irritation, dryness.
TETRALYSAL
Galderma
2NO 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,
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 lactation. B Hepatic or renal insufficiency. C Antacids/iron preps., anticoagulants. A GI disturbances, diarrhoea, superinfection, photosensitivity.
WART 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. ZINDACLIN Crawford V Apply one or two drops to dry wart at night after soaking. Remove elastic film in 2NO Antibacterial. Clindamycin (as phosphate) 1%. Gel. morning and re-apply. Rub with pumice between applications. 30g, A9.50. D Facial and anogenital warts. S Mild to moderate acne vulgaris. B Avoid healthy skin. P Apply thin film once daily. Q Under 12 years, not recommended. DUOFILM Stiefel D Lincomycin sensitivity. B Avoid contact with eyes and mucous 2 membranes. Pregnancy. Keratolytics. Salicylic acid 16.7%, lactic acid 16.7%; C In vitro erythromycin, metronidazole, liquid. 15ml with applicator, A3.49. aminoglycosides. S Plantar and mosaic warts. A Dry skin, erythema, irritation, acne V Apply daily, avoiding normal skin. Allow exacerbation, pruritus. Rarely, diarrhoea or colitis to dry and cover with plaster. Pare down surface (discontinue immediately). of wart between applications. D Facial and anogenital warts. ZINERYT Astellas B Avoid healthy skin.
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.
GLUTAROL 2
TREATMENTS
15.6
lesion disappears. D Inflamed or broken skin. Diabetes. A Localised pain and redness.
15.7 WOUND MANAGEMENT
CUBITAN
Nutricia
1O Oral nutritional. Protein 20g, arginine enriched 3g, vitamins, minerals, trace elements per 200ml. Nutritionally balanced sip feed. (3 flavours). 1.25 kcal/ml. Plastic bottle with straw- 200ml, A2.07. S Assist the healing of pressure sores. Q Under 3 years, 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 complete. 200ml bottle with straw attached (2 flavours), A2.07. S Acute or chronic wounds or patients with poor wound healing. Dermal Q Under 6 years, caution. Under 1 year, not recommended.
Virucidal-anhidrotic. Glutaraldehyde 10%; soln. 10ml with applicator, A4.04. S Warts, particularly plantar warts. V Apply twice daily (a plaster is unnecessary). Pare down hard skin. D Facial and anogenital warts. B Avoid healthy skin. A Stains skin during treatment.
EPIGLU
Synapse
Tissue adhesive. Ethyl-2-cyanoacrylate 95 45mg, polymethylmethacrylate. Epiglu 01:1 x 3g vial, 20 applications, 20 pipets, 1 dosage tray, A53.00; Epiglue 02: 2 x 3g vial, 40 applications, 40 pipets, 2 dosage trays, A82.00; Epiglu 04: 4 x 3g vial, 80 applications, 80 pipets, 4 dosage trays, A120.00. S Tissue adhesive for external use. Apply OCCLUSAL Alliance to fresh incisions and lacerations (also postoperative). For the closure of wounds after careful 2 15.6 WART TREATMENTS adaptation of the wound edges, as a suture Keratolytic. Salicylic acid 26%; soln. 10ml, A4.94. substitute, and for additional suture support. COMPOUND W SSL Healthcare S Warts. Apply two applications allowing D Do not use on contaminated ot to dry between each. Repeat daily, abrading wart 2K inflamed tissue. before applying. B Avoid contact with eyes. Keratolytic. Salicylic acid 17%; sln 6.5ml with D Facial and anogenital warts. applicator, A3.39. B Avoid healthy skin. IRUXOL MONO Smith & Nephew S Warts and verrucas. V Rub the hard skin from the surface and SALACTOL Dermal 2 N O apply to wart/verruca once daily for up to 4 weeks Clostridiopeptidase A 1.2 units/g, associated 2 and cover with plaster. enzymes 0.24 units/g. Oint. 20g, A10.99. Keratolytics. Salicylic acid 16.7%, lactic acid 16.7%. S Debridement of necrotic wounds and D Moles, birth marks, genital or facial Paint. 10ml with applicator, A4.02. warts. varicose ulcers, diabetic ulcers, bed sores. S Warts, verrucae, corns and calluses. B Avoid eyes and mucous membranes. D Major burns. V Apply to wart once daily and, for Consult doctor if diabetic. Children under 6 years B Antiseptic solns. and soaps not to be (only on medical advice). Flammable. Do not apply plantar warts, cover with a plaster. Rub with used. pumice between applications. to healthy skin or broken or inflamed skin. C Tyrothricin, gramicidin, tetracyclines. D Facial and anogenital warts. A Local pain, burning, pruritus. CUPLEX Smith & Nephew B Avoid healthy skin. 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.
SALATAC GEL
Dermal
2
REGRANEX
Janssen-Cilag
;N
rhPDGF. Becaplermin 100mcg/ml gel. 15g tube, A488.79. S Granulation and thereby healing of fullthickness, neuropathic, chronic, diabetic ulcers R 5cm2. P Apply as thin layer to ulcerated area once daily using clean application aid. Cover by moist saline gauze dressing. Max 20 weeks. Q Not recommended. D Known neoplasm at or near appl. site, VERICAPS Ovelle infected ulcers, ulcers not of primarily neuropathic 2 origin. Pregnancy, lactation. Keratolytic. Salicylic acid 10%. Paste in adhesive B Treat infection, exclude/treat felt plaster. 1 treatment pack, A4.19. osteomyelitis and peripheral arteriopathy first. Under supervision of physicians experienced in V Apply medicated centre to wart, leave management of diabetic wounds. in place for two days, scrape away loose debris. C Topical drugs at same site. Apply fresh plaster and repeat treatment until
Keratolytics. Salicylic acid 12%, lactic acid 4%. Gel. 8g (plus applicator, emery board and instructions), A5.86. S Warts, verrucae, corns and calluses. V Apply to wart once daily. Abrade, using emery board supplied, once a week. D Facial and anogenital warts. B Avoid healthy skin.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
281
15.8 TOPICAL
DERMATOLOGY
CORTICOSTEROIDS
children Q1 year; untreated bacterial, viral, tuberculosis or fungal infections. Pregnancy, lactation. Neomycine: Otitis externa when ear drum perforated. ROWAROLAN B Long term therapy (avoid). Use with occlusive dressing. Avoid eyes. Psoriasis (caution). 2 BETNOVATE GSK Possibility of hypercortisolism, adrenocortical Exudate absorbant. Koraterrit (Creta Praep.) 90%. suppression, growth suppression, especially in 2MO powder. 20g, A3.60. Potent steroid. Betamethasone (as valerate) 0.1%. children. S Leg ulcers, bed sores and similar A Local skin burning and pruritus. Cream and oint. 30g, A1.64; 100g, A4.57. conditions. S Psoriasis, lichen simplex and planus, P Sprinkle powder at least 3 times daily UCB eczema, prurigo nodularis, seborrhoeic dermatitis, BETTAMOUSSE on affected area. 2NO contact dermatitis, discoid lupus erythematosus. ZIPZOC Smith & Nephew Adjunct to systemic steroid therapy in generalized Potent steroid. Betamethasone (as valerate) 0.1%; erythroderma, insect bite reactions and prickly scalp application. 100g, A9.36. 2 heat. S Steroid responsive dermatoses of the Zinc oxide 20%. Sterile rayon stocking V Apply sparingly 1-3 times daily. Under 3 scalp. impregnated with oint. Case-4, A21.33; Case-10, years, max. duration 3 weeks. P Apply no more than a golf ball sized A53.33. 2 M O amount to scalp morning and night until S Aid in treatment of chronic leg ulcers. noticeable improvement. If no improvement after P Apply to lower leg and cover with outer ALSO BETNOVATE RD Betamethasone (as A 7 days, discontinue. Maintenance, apply once daily valerate) 0.025%. Cream and oint. 100g, 3.81. bandage. In chronic venous insufficiency apply or less frequently. S Maintenance treatment when control under compression bandaging. Change stocking as Q Under 6 years, not recommended; over has been achieved with Betnovate. required, max. weekly. 6 years, in proportion to dose for adults. Limit use V Apply 1-3 times daily. Under 3 years, D Arterial leg ulcers. for 5-7 days. max. duration 3 weeks. A Rash, erythema, itching, maceration of D See SPC. 2 M O wound edge. ALSO BETNOVATE-C Betamethasone (as valerate) B Avoid eyes, open wounds, mucous membranes. Do not use with occlusive dressings. 15.8 TOPICAL CORTICOSTEROIDS 0.1%, clioquinol 3%; cream. 30g, A2.00. S As Betnovate when infection due to Galderma ALPHADERM Alliance micro-organisms sensitive to anti-infective is likely. CALMURID HC 2MO V Apply sparingly 2-3 times daily. 2MO Maintenance, apply once daily or less. Hydrating/keratolytic agents/mildly potent steroid. Moderately potent steroid/hydrating agent. Urea 10%, lactic acid 5%, hydrocortisone 1%; Hydrocortisone 1%, urea 10%. Cream. 30g A2.88; 2 M O cream. 100g, A11.35. ALSO BETNOVATE SCALP APPLICATION 100g, A8.93. S Eczema, dermatitis. Betamethasone (as valerate) 0.1%. Soln. 100ml, S Treatment of all dry ichthyotic, A5.99. V Apply twice daily after washing. eczematous conditions of the skin. D See SPC. S Steroid-responsive dermatoses of the V Apply twice daily to dry cleansed skin. scalp, eg. psoriasis, seborrhoea capitis and D See SPC. CANESTEN-HC Bayer HealthCare inflammation associated with severe dandruff. BETACAP SCALP APPLICATION V Apply sparingly morning and evening. 2 M O Maintenance, apply once daily or less. Under 3 Antifungal/mildly potent steroid. Clotrimazole 1%, Dermal years, max. duration 3 weeks. hydrocortisone 1%. Cream. 30g, A3.68. 2MO D Rosacea, acne vulgaris, peri-oral S Fungal infections accompanied by Potent steroid. Betamethasone (as valerate) 0.1% dermatitis; peri-anal and genital pruritus; primary inflammation. with coconut oil derivative 100ml, A4.79. cutaneous viral infections; widespread plaque V Apply twice daily, thinly and evenly. psoriasis, except single lesions; dermatoses in S Steroid responsive dermatoses of the D Bacterial/viral skin diseases, vaccination reactions, perioral dermatitis, broken skin, acne. PRESCRIBING NOTES Large areas, long-term use, under occlusive TOPICAL CORTICOSTEROIDS dressing. Topical corticosteroids are effective in inflammatory dermatoses, not caused by infection, such as eczema B Pregnancy, lactation (only if essential). and psoriasis. They act by reducing the inflammatory response but do not cure the condition, which often A Irritation/burning, hypersensitivity returns on cessation of treatment. There are guidelines to their appropriate use. Apply an appropriately reactions. 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. Rowa D See SPC.
A Infection, osteomyelitis, cellulitis, skin ulceration, skin disorder (including erythema), pain.
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.
282
CLARELUX
Pierre Fabre
2MO Very potent steroid. Clobetasol propionate 500mcg/g. White foam. 100g. S Steroid responsive dermatoses of the scalp such as psoriasis, which do not respond satisfactorily to less active steroids. P Apply to affected area twice daily for no more than 2 consecutive weeks. Max. 50g/ week. Q Not recommended. D Burns, rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus. Primary infected skin lesions caused by viruses, fungi or bacteria. Use on face. Pregnancy, lactation (unless clearly necessary). B Avoid long-term therapy. Chronic intermittent use, assess Hypothalamic-PituitaryAdrenal (HPA) axis function periodically. Secondary infection may develop. Caution: Liver impairment. Rebound relapses can follow
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
TOPICAL
development of tolerance. Risk of developing generalised pustular psoriasis and local or systemic toxicity. Cataracts may develop. Should not be used with occlusive dressings (unless supervised by a physician). Contains propylene glycol, cetyl alcohol and stearyl alcohol. A Application site reactions.
CORTOPIN HYDROCORTISONE
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
Pinewood ALSO DIPROSALIC SCALP APPLICATION
2K Mildly potent steroid. Hydrocortisone 1%; cream. 15g, A2.45. S Contact dermatitis, irritant dermatitis, mild to moderate eczema, insect bite reactions. V Apply twice daily to affected area for not more than 7 days. D See SPC.
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
CORTICOSTEROIDS
15.8
resistance to treatment. Abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. If use required below 18 years, review treatment weekly. Do not treat skin areas other than scalp. If product enters the eye, rinse with copious amounts of water. A Skin discomfort, acne/folliculitis, eye stinging/burning. Very rarely: Hypercortisolism (Cushing syndrome) or HPA axis suppression (prolonged use, treatment of extensive areas, use of large amounts).
EUMOVATE
GSK
2MO Moderately potent steroid. Clobetasone butyrate 0.05%; cream and oint. 30g, A2.03.
Schering-Plough S Mild eczema, seborrhoeic dermatitis and
2MO
Potent steroid. Betamethasone dipropionate DAKTACORT Janssen-Cilag 0.05%. Cream and oint. 30g, A2.99; 100g, A8.52. S Steroid responsive dermatoses of the 2MO skin. Antifungal-antibacterial. Miconazole nitrate 2%, V Apply sparingly once or twice daily. hydrocortisone 1%; cream. 30g, A2.60. S Skin conditions where inflammation and 2 M O ALSO DIPROSONE LOTION Betamethasone infection by susceptible organisms co-exist. dipropionate 0.05%. Acoholic soln. 30ml, A3.79; V Apply one or three times daily. Avoid 100ml, A10.84. treatment for longer than 3 weeks in children S Serious steroid responsive dermatoses of under 3 years. the scalp. D See SPC. V Apply a few drops twice daily. DERMOVATE GSK D See SPC.
other steroid-responsive disorders. Maintenance therapy between courses of more potent topical steroids in the more resistant dermatoses. V Apply up to four times daily. D See SPC.
EURAX-HYDROCORTISONE Novartis Consumer
2MO
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 2MO ELOCON Schering-Plough caution in infants and for not more than 7 days. Potent steroid. Clobetasol propionate 0.05%; D Acute exudative dermatoses, skin 2NO cream and oint. 30g, A2.97; 100g, A8.71. S Psoriasis, intractable eczemas and other Potent steroid. Mometasone furoate 0.1%. Cream, infections. See SPC. oint. and scalp lotion. Cream and oint.-30g, A5.78; inflammatory dermatoses. FUCIBET LEO Pharma P Apply sparingly once or twice daily; for Cream and oint.-100mg, A15.00; Scalp lotion2NO A5.78. 30ml, max. four weeks, then review. Potent steroid/antibacterial. Betamethasone Q Same as adult but review weekly. Under S Inflammatory and pruritic valerate 0.1% and fusidic acid 2%. Fucibet Cream: manifestations of psoriasis (excluding widespread 3 years, max. duration 3 weeks. Homogenous cream; Fucibet Lipid: Viscous oil-inplaque psoriasis) and atopic dermatitis. Scalp 2MO water emulsion cream (equiv. ointment). 15g, psoriasis and seborrhoeic dermatitis. ALSO DERMOVATE SCALP APPLICATION A4.51; 30g, A7.57. P Apply once daily to affected area. Clobetasol propionate 0.05%. alcoholic soln. Q Under 2 years, not recommended; over S Inflammatory dermatoses where 100ml, A11.48. bacterial infection is present or suspected. 2 years, same as adult. V Apply sparingly once or twice daily. V Apply twice daily. Usual max. duration, D See SPC. Under 3 years, max. duration 3 weeks. 2 weeks. D Rosacea, acne vulgaris and peri-oral ETRIVEX Galderma D Skin infections primarily caused by dermatoses; peri-anal and genital pruritus; primary bacteria, fungi or virus, skin manifestations in 2O cutaneous viral infections; widespread plaque relation to tuberculosis or syphilis, acne vulgaris, Very potent steroid. Clobetasol propionate psoriasis, except single lesions; dermatoses in perioral dermatitis and rosacea. Pregnancy, 500mcg/g. Shampoo, 125 ml. A16.08. children Q1 year; untreated bacterial, viral, lactation (unless clearly necessary). S Topical treatment of moderate scalp tuberculosis or fungal infections. Extensive use in B Prolonged use, large areas. Avoid: psoriasis in adults. pregnancy. P Apply approx. 7.5 ml (half a tablespoon) Atrophic skin, cutaneous ulcers, acne vulgaris, B Long term therapy (avoid). Use with fragility of skin veins, perianal/genital pruritus. once daily. Max treatment duration: 4 weeks. occlusive dressing. Avoid eyes. Psoriasis (caution). Avoid open wounds and mucous membranes. When improvement observed, space out Possibility of adrenocortical suppression, growth applications or replace by alternative treatment if A Appl. site irritation, allergic reaction. suppression, hypercortisolism, especially in needed. If no improvement in 4 weeks, reassess children. Lactation. FUCIDIN H LEO Pharma diagnosis. Repeated courses may be used to A Local hypersensitivity reactions. Striae, 2NO thinning of the skin, dilatation of superficial blood control exacerbations. Antibacterial/mildly potent steroid. Sodium Q Under 2 years, contra-indicated. Under vessels (prolonged use). fusidate 2%, hydrocortisone acetate 1%. 18 years, not recommended. Ointment. 15g, A3.15; 30g, A5.47. DIODERM Dermal D Skin areas affected by bacterial, viral, 2NO fungal or parasitic infections and specific skin 2MO diseases (skin tuberculosis, skin diseases caused by ALSO FUCIDIN H CREAM Fusidic acid 2%, Mildly potent steroid. Hydrocortisone 0.1%; cream. lues). Do not apply to the eye (risk of glaucoma) hydrocortisone acetate 1%. Cream. 15g, A3.85; 30g, A3.16. or to ulcerous wounds. Pregnancy, lactation 30g, A6.65. S Inflammatory, pruritic and allergic skin (unless clearly necessary). S Inflammatory dermatoses where conditions. B May occur: Post treatment rebound bacterial infection is present or suspected. V Apply sparingly and rub in well twice relapses, tolerance (tachyphylaxis) and local or V Apply one to four times daily or as daily. systemic toxicity; use with caution. Intensive and required. Under 3 years, max. duration 3 weeks. D See SPC. prolonged use: Evaluate regularly for HPA axis D Infections due to non-sensitive suppression signs; generalised pustular psoriasis organisms. Pregnancy. DIPROSALIC Schering-Plough may occur. Suspect hypersensitivity in case of B Prolonged use. Lactation. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
283
15.9 MISCELLANEOUS
DERMATOLOGY
HC45 HYDROCORTISONE
Potent steroid/antifungal. Betamethasone (dipropionate) 0.064%, clotrimazole 1%. Cream. 30g, A9.03. 2 S Short term treatment of cutaneous Mildly potent steroid. Hydrocortisone acetate 1%; fungal infections. cream. 15g, A2.63. V Apply morning and evening for 2 weeks S Mild to moderate eczema, irritant in tinea cruris, tinea corporis and candidiasis, and contact dermatitis, allergic contact dermatitis, for 4 weeks in tinea pedis; under 12 years, not insect bite reactions. recommended. V Over 10 years, use sparingly on small D Facial rosacea, acne vulgaris, perioral areas, once or twice daily, for max. 7 days; under dermatitis, napkin eruptions, bacterial or viral 10 years, under medical supervision. infections. D See SPC. B Continued use on large areas, damaged skin, in flexures, occlusive dressing. Pregnancy, HYDROCORTISYL CREAM sanofi- lactation. aventis A Local mild burning, irritation. Hypersensitivity reactions. 2OY Mildly potent steroid. Hydrocortisone 1%. 15g, MODRASONE Teva A1.75. 2MO S Corticosteroid-sensitive superficial dermatoses (Prescription). Contact dermatitis, Moderately potent steroid. Alclometasone irritant dermatitis and insect bite reactions dipropionate 0.05%. Cream and oint. 15g, A1.97; (Pharmacy). 50g, A5.59. 2MO S Corticosteroid responsive dermatoses. ALSO HYDROCORTISYL OINTMENT Hydrocortisone V Apply two or three times daily. A D See SPC. 1%. 15g, 1.75. S Corticosteroid-sensitive superficial TRAVOCORT Bayer Schering dermatoses. V Apply one to four times daily. Under 12 2 M O yrs: Apply sparingly over small area once or twice Antifungal/potent steroid. Isoconazole nitrate 1%, daily for max. 1 week (under medical supervision). difluocortolone valerate 0.1%; cream. 15g, A2.97. D Untreated bacterial, viral, tuberculous or S Fungal and Gram-positive bacterial fungal infections. Acne rosacea. Perioral infections accompanied by inflammation. dermatoses. Plaque psoriasis. Use on eye, face, V Massage into affected area morning anogenital region, broken/infected skin, cold and evening. sores, acne and athletes foot. D See SPC. B Use with occlusive dressings. Continuous application without interruption may lead to local VIOFORM HYDROCORTISONE atrophy, striae, superficial vascular dilation, Novartis Consumer adrenocortical suppression or growth retardation. 2MO Prolonged use for acne vulgaris. Use in psoriasis Antibiotic-antifungal/mildly potent steroid. may lead to generalisation, excessive systemic Clioquinol 3%, hydrocortisone 1%. Cream and absorption and rebound relapse on cessation. oint. 30g, A1.83. Local skin reaction. S Eczema, dermatosis, ano-genital A Striae, hypersensitivity. pruritus, infected insect bite reactions. LOCOID Astellas V Apply sparingly 1-3 times daily. Not for use in children under 2 years. 2MO D See SPC. Medium potent steroid. Hydrocortisone 17Reckitt Benckiser
butyrate 0.1%; cream and oint. 30g, A2.58; 100 g, A7.89.
S Corticosteroid sensitive dermatoses. V Apply two to three times daily.
15.9 MISCELLANEOUS
ANHYDROL FORTE 2
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
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
McNeil Healthcare
2 Vasodilator. Minoxidil 2%, 5%; proof liquid. 2%60ml, A17.78; 5%-60ml, A20.95; 3 x 60ml, A45.81. S Male and female alopecia androgenetica. P 18-65 years, 1ml applied to the affected area of the scalp twice daily. D Pregnancy. B Avoid eyes, mucous membranes, sensitive or damaged skin. A Local irritation, allergic reactions.
VANIQA
Shire
2NO
Ornithine decarboxylase inhibitor. Eflornithine (as monohydrate Cl) 11.5% w/w. Cream. 30g, A29.78. S Facial hirsutism in women. P Apply twice daily, at least eight hours apart. Rub in thoroughly. Do not cleanse within four hours of application. Max.: 30g per month. Continued treatment necessary to maintain beneficial effects. Q Under 12 years, not recommended. D Pregnancy, lactation (no data). B Consider underlying cause (e.g. PCOS, androgen secreting neoplasm, certain medications). Cutaneous use on areas of face and Dermal under chin only. Avoid contact with eyes or mucous membranes (e.g. nose or mouth). Severe
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.
2MO
284
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
COMBINED ORAL
CONTRACEPTIVES
16.1
contraceptive effectiveness, all tablets should be renal impairment. A Acne, pseudofolliculitis barbae, alopecia, taken at approximately the same time each day. D See Drug Prescribing Notes. rash, folliculitis, pruritis, erythema. Dry, irritated, stinging, burning, or tingling skin.
LEONORE
16.1 COMBINED ORAL CONTRACEPTIVES
coated tabs. 3 x 21, A9.00 (1 month 21, A3.00). S Oral contraception. P One daily for 21 consecutive days starting on the first day of menstruation, followed by 7 tablet-free days. D See Drug Prescribing Notes. B Contains lactose.
DIANETTE
Janssen-Cilag
2MO Progestogen/oestrogen. Norgestimate 0.25mg, ethinyloestradiol 35mcg. dark blue tab. marked C 250 each side. 21, A2.17. S Oral contraception. 1 daily for 21 days starting on the first day of the menstruation, then 7 tablet-free days. To obtain maximal
Oestrogen/progestogen. Levonorgestrel 100mcg,
Bayer Schering ethinylestradiol 20mcg. White round biconvex
2MO
BREVINOR Pharmacia Oestrogen/progestogen. Ethinyloestradiol 35mcg, cyproterone acetate 2mg. Beige sug-ctd biconvex 2MO tab. 21, A5.58. Oestrogen/progestogen. Ethinyloestradiol 35mcg, S Contraceptive for females with severe norethisterone 0.5mg. Blue round, flat beveledacne vulgaris. edge tab. marked SEARLE on one side and BX on P 1 daily. First course begins on first day the other. 21, 67c. of menses, with seven day interval between 21 S Oral contraceptive. 1 daily for 21 days day courses. starting on first day of menstruation, then 7 D See SPC. tablet-free days. D See Drug Prescribing Notes. ESTELLE Clonmel CILEST
Rowex
2MO
2MO Oestrogen/progestogen. Ethinylestradiol 30mcg, gestodene 75mcg. White, round, biconvex sugarctd tabs. 21, A2.14. S Oral contraception. 1 daily for 21 days, starting on first day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes. B Contains lactose and sucrose.
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
LOGYNON
Bayer Schering
2MO Oestrogen/progestogen. Ethinyloestradiol 30mcg, levonorgestrel 50mcg (6 brown tabs.); ethinyloestradiol 40mcg, levonorgestrel 75mcg (5 white tabs.); ethinyloestradiol 30mcg, levonorgestrel 125mcg (10 ochre tabs.); sug-ctd tabs. 21, A3.71. S Oral contraception. P 1 daily for 21 days starting on 1st day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
MARVIOL
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.
MICROLITE
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.
MINULET
Wyeth
2MO Oestrogen/progestogen. Ethinyloestradiol 30mcg, gestodene 75mcg; white sug-ctd tab. 3 x 21, A6.54. S Oral contraception. 1 daily for 21 days, starting on first day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
OVRANETTE
Wyeth
2MO Oestrogen/progestogen. Ethinyloestradiol 30mcg, levonorgestrel 150mcg. Round white sugar-ctd tab. 21, A0.71. S Oral contraception.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
285
16.2 PROGESTOGEN-ONLY
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
CONTRACEPTION
CONTRACEPTIVES
Bayer Schering
2MO Oestrogen/progestogen. Estradiol valerate 3mg (2 dark yellow tabs marked DD), estradiol valerate 2mg and dienogest 2mg (5 medium red tabs marked DJ), estradiol valerate 2mg and dienogest 3mg (17 light yellow tabs marked DH), estradiol valerate 1mg (2 dark red tabs marked DN). 2 white tabs marked DT without active substance. 1 wallet (28 tabs), A8.49. S Oral contraception. P Start on day 1 of natural cycle. Take tabs in directed order every day for 28 days at about same time with liquid. Start subsequent pack day after last tab. of previous wallet. D See Drug Prescribing Notes.
during and for 28 days after admin. Medical charcoal. A Bleeding irregularity, acne, mood changes, breast pain, nausea, weight increase, Bayer Schering headache, libido decrease.
starting on first day of menstruation, then 7 tablet-free days. D See Drug Prescribing Notes.
YAZ 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.
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 16.2 PROGESTOGEN-ONLY activity of virus. CONTRACEPTIVES P 150mg every 3 months by IM inj. in gluteal muscle. Initial inj. during 1st 5 days after CERAZETTE Schering-Plough onset of menstrual period; or within 5 days postpartum if not breast-feeding or after 6 weeks 2MO if breast-feeding. Progestogen. Desogestrel 75mg. White, round, Q Not indicated before menarche. biconvex film-ctd tab. with one side coded KV D Thrombo-embolic disorders. Breast or YASMIN Bayer Schering above 2 and Organon on reverse. 28, A5.90. genital cancer (known or suspected to be S Contraception. 2MO P 1 every day at about same time with 1st oestrogen dependent). Impaired liver function, Oestrogen/progestogen. Ethinyloestradiol 30mcg tab. taken on 1st day of menstrual bleeding. Start active liver disease. Undiagnosed abnormal vaginal drospirenone 3mg. Light yellow film-ctd tab. bleeding. Pregnancy. marked DO in a hexagon one side. 3 x 21, A16.89 new blister directly the day after previous one. B Diabetes, depression, cardiovascular or D Pregnancy, active venous (1 month 21, A5.63). renal disease, asthma, epilepsy. Associated with thromboembolic disorder, presence/ history of S Oral Contraception. 1 daily for 21 days loss of BMD. Use long-term (q 2 yrs) only if other severe hepatic disease as long as liver function starting on first day of menstruation, then 7 birth control methods unsuitable. Small increase in values not normal, sex-steroid sensitive tablet-free days. breast cancer risk, especially in older women. malignancies, undiagnosed vaginal bleeding. D See Drug Prescribing Notes. Potential for delay in return to full fertility B Benefit/risk assessment required if following use. Sudden loss of vision, proptosis, YASMINELLE Bayer Schering presence/ appearance/ aggravation of: Breast cancer, liver cancer, disturbances of liver function. diplopia, migraine, jaundice; do not re-admin. 2MO pending examination. Caution: History of thrombo-embolic disorders, C Aminoglutethimide. Oestrogen/progestogen. Ethinylestradiol 0.020mg diabetes. Discontinue if: Thrombosis, long-term (as betadex clathrate), drospirenone 3mg. Light immobilisation due to surgery or illness, sustained A Amenorrhoea, oligomenorrhoea, dysmenorrhoea, back pain, fluid retention. pink, round film-ctd tab. with convex faces, hypertension. Avoid sun/UV if tendency to embossed DS in a regular hexagon. 3 x 21, chloasma. Contains lactose. NORIDAY Pharmacia A19.50. (1 month, 21 A6.50). C Microsomal enzyme-inducing drugs (see Drug Prescribing Notes), use a barrier method S Oral Contraception. 1 daily for 21 days 2MO Progestogen. Norethisterone 350mcg. White tab. PRESCRIBING NOTES marked SEARLE and NY. 28, A3.14. PROGESTERONE-ONLY ORAL CONTRACEPTIVES S Oral contraception. Starting on first day Progesterone-only Pills (POP). Oral progesterone only contraceptives can be used as an alternative in of menstruation, 1 at the same time daily without those women where estrogens are contra-indicated i.e. patients with family history of venous thrombosis. any break in medication. They are suitable for older women, smokers, hypertensives, those with diabetes mellitus and those who D Confirmed or suspected pregnancy. Acute or chronic liver disease, jaundice, pruritus, suffer from migraine. Some women, experience severe headaches or high blood pressure from the Dubin-Johnson syndrome, Rotor syndrome. oestrogen in the combined pill and must take the progesterone-only pill. Progesterone-only pills must be Thromboembolic disorders, steroid dependent taken at precisely the same time each day to maintain top effectiveness. If a woman deviates from her pill neoplasia. Disorders of lipid metabolism, schedule for even three hours, she must take the missed pill immediately and then resume the normal undiagnosed vaginal bleeding. schedule; she must also use back-up contraception for the next seven days. B Pain and tightness in chest, migraine If changing from a combined preparation, commence pill taking immediately after the completion of the headaches, vision/hearing disturbances. previous combined pack, omit any inactive pills if present (ED brands). Following childbirth, administration Discontinue 6 weeks before elective surgery. can commence 3 weeks postpartum, and there is no effect on lactation. Epileptic seizures, elevated BP, onset of severe Progesterone-only pill users will experience lighter periods than those taking combination pills; some may depression. Caution: Diabetes mellitus, varicose not have periods at all. Spotting and bleeding between periods (break-through bleeding) however are side veins, tetany, Syndenhamâ&#x20AC;&#x2122;s chorea, breast cancer (or history of). Asthma. Reassess therapy after age effects of progesterone. This hormone may also produce fatigue, decreased sex drive, acne, and depression. of 35 years. See SPC. Effectiveness is not reduced by broad-spectrum antibiotics but is affected by enzyme inducing drugs. The C Rifampicin or other antibiotics, antiFamily Planning Association recommends that additional precautions should be taken whist taking such epileptics, barbiturates, sedatives, steroids, TCAs, drugs and for seven days following. Rifampicin and rifabutin are so potent these precautions should be anticoagulants, corticosteroids. continued for at least 4 weeks after cessation of treatment. There is no need to withdraw a POP before A Headaches, GI disturbances, breast surgery. Vomiting within three hours of taking a pill or severe diarrhoea should be considered as a tenderness, weight changes, fluid retention, potential threat to contraceptive cover, consequently additional precautions should be used during, and depressed mood, candidiasis, rash, urticaria, until seven days after recovery. erythema nodosum, erythema multiform, alopecia, Use of the progesterone-only pill leads to a small increase in risk of breast cancer, The most important risk irregular menstrual pattern. 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.
286
16.3 LONG-TERM CONTRACEPTIVES
IMPLANON
Schering-Plough
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
CONTRACEPTION Progestogen. Etonogestrel 68mg per implant 1, A120.47. S Contraception. P 1 implant inserted subdermally; see SPC. D Active venous thromboembolic disorder, progestagen-dependent tumours, presence or history of severe hepatic disease as long as liver function values have not returned to normal. Known or suspected pregnancy, undiagnosed vaginal bleeding. B Hypertension, presence or history of thromboembolic disorders. Hormone dependent carcinoma. Liver dysfunction, glucose tolerance. Women with tendency to chloasma should avoid exposure to sun or UV. Ectopic pregnancy. Changes in vaginal bleeding pattern. Examine BP, pelvic organs and breasts before and regularly during treatment. C Hydantoins, barbiturates, primidone, carbamazepine or rifampicin, oxcarbazepine, rifabutin, troglitazone, griseofulvin. A Acne, headache, increase in body weight, breast tenderness and pain, alopecia, depressive moods, emotional lability, changes in libido, abdominal pain, dysmenorrhoea.
EMERGENCY CONTRACEPTION 16.4 cystocele/rectocele, severe/chronic constipation. C Microsomal enzyme inducers (phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, possibly oxcarbazepine, topiramate, flebamate, ritonavir, griseofulvin, St John’s wort). Penicillins, tetracyclines. A Acne, headache/migraine, depression, mood swings, decreased libido, abdominal pain, nausea, weight gain, breast pain, device related problems, dysmenorrhoea, leukorrhoea, vaginal discomfort, vaginitis.
heavy menses, diarrhoea, bleeding, delay of menses.
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 16.4 EMERGENCY CONTRACEPTION (1 month), A10.90; 9 patches (3 months), A29.78. S Female contraception. LEVONELLE Berlipharm P 1 patch weekly for 3 consecutive weeks, 2NO starting 1st day of menstruation, followed by 1 patch-free week. Progestogen. Levonorgestrel 1500mcg. Round Q Not recommended. white tab. marked G00. 1, A6.32. D Presence or history of or hereditary S Emergency contraception within 72 hours of unprotected sexual intercourse or failure predisposition for venous/arterial thrombosis. Prodromi of a thrombosis. Multiple risk factor(s) of a contraceptive method. for arterial thrombosis. Migraine with focal aura. P 1 taken as soon as possible (preferably within 12 hours and no later than 72 hours) after Carcinoma of the breast or endometrium or other unprotected intercourse. If vomiting occurs within estrogen-dependent neoplasia 3 hours of taking tab., take another immediately. Hepatocellular disease. Hepatic adenomas/ Q Under 16 years, not recommended (very carcinomas. Undiagnosed abnormal genital MIRENA Bayer Schering limited data). bleeding. Pregnancy, lactation. B Thromboembolic and other vascular D Pregnancy. 2NO B Repeated admin. within menstrual cycle disorders. Increased risk of venous IUS. Levonorgestrel 52mg. T-shaped intrauterine not advisable. If pregnancy occurs after treatment, thromboembolism (VTE). Caution: Smoking, system. 1, A107.88. evaluate for ectopic pregnancy. History of ectopic hypertension, obesity, increasing age, family S Contraception. history. Monitor renal and liver function. pregnancy, severe hepatic dysfunction; not P To be inserted into the uterine cavity Depression, epilepsy, Crohn’s disease, UC, recommended. Severe malabsorption syndrome within 7 days of the onset of menstruation. chloasma may worsen. Irregular blood loss, esp. Replace after 5 years. Delay post-partum use until e.g. Crohn’s disease. Lactation. Contains lactose. initial months of use. Amenorrhoea or C Liver enzyme inducers e.g. barbiturates 6 weeks after delivery. oligomenorrhoea may occur after discontinuing. (incl. primidone), phenytoin, carbamazepine, St. D Pregnancy, pelvic inflammatory disease, C Certain antibiotics (e.g. ampicillin, John’s Wort, rifampicin, ritonavir, rifabutin, postpartum endometritis, infected miscarriage tetracycline), hepatic enzyme inducers (rifampicin, griseofulvin. May increase ciclosporin toxicity. (past 3 months), cervicitis, cervical dysplasia, hydantoins, barbiturates, primidone, A Fatigue, headache, dizziness, breast uterine or cervical malignancy, undiagnosed carbamazepine, rifampicin, bosentan, tenderness, GI disorders, bleeding pattern genital bleeding, uterine anomaly, genital oxcarbazepine, topiramate, felbamate, ritonavir, disturbances. infection, acute liver tumour, severe hepatic griseofulvin, modafinil, phenyl butazone, St John’s disease, progestogen-dependent tumours. NORLEVO Ferring Wort), lamotrigine, ciclosporin. Take additional B Severe arterial disease, migraine, non-hormonal contraceptive during concurrent 2 N O exceptionally severe headache, jaundice, marked medication and for 7 days after (up to 28 days increase of BP, hormone dependent neoplasia incl. Progestogen. Levonorgestrel 1.5mg. White, round after for hepatic enzyme inducers). biconvex tab. marked NL 1.5. 1, A6.22. breast cancer, history of thromboembolism, may A Dizziness, migraine, GI disturbances, S Emergency contraception within 72 affect glucose tolerance. Lactation. hours of unprotected sexual intercourse or failure weight increase, myalgia, depression, emotional C Caution: Liver enzyme inducing drugs. lability, reproductive disorders, sinusitis, upper RTI, A Weight gain, oedema, headache, lower of a contraceptive method. acne, pruritis, rash, UTI, +ve cervical smear test, P 1 tab. as soon as possible, preferably abdominal pain, back pain, acne, vaginal within 12 hours after unprotected intercourse and breast fibroadenosis. discharge, cervicitis, dysmenorrhea, mastalgia, breast tension, depression, mood changes, nausea, Q72 hours. May be taken anytime during 17.1 DYSMENORRHOEA menstrual cycle. If vomiting occurs within 3 hours expulsion. of taking tab., take another tab. immediately. ADVIL LIQUIGELS Wyeth Healthcare NUVARING Schering-Plough Q Not applicable. 2K B Emergency contraception is an 2NO NSAID. Ibuprofen 200mg. Green translucent, oval occasional method. If unprotected intercourse Oestrogen/progestogen device. Each ring: 11.7mg q72 hours earlier in same menstrual cycle, soft gelatin cap. marked Advil one side in white etonogestrel, 2.7mg ethinylestradiol (releasing ink. 20, A3.20. conception may have occurred. If no period 120mcg etonogestrel, 15mcg ethinylestradiol per S Mild to moderate pain (rheumatic/ occurs, exclude pregnancy. If pregnancy occurs day). Flexible transparent, colourless vaginal ring. muscular pain, backache, headache, dental pain, exclude ectopic pregnancy. Severe hepatic Diameter 54mm, cross sectional diameter, 4mm. 1 dysfunction, history of ectopic pregnancy; not dysmenorrhoea), feverishness, cold and flu Ring, A8.00; 3 Rings, A24.00. symptoms. recommended. Severe malabsorption syndromes S Contraception. P 1-2 caps. every 4-6 hours. Max. 6 in 24 (e.g. Crohn’s disease) might impair efficacy. P Each ring should be used continuously hours. Thromboembolic events may occur (to be for 21 days followed by removal for 7 days. considered in case of thromboembolic risk factors). Q Under 12 years, not recommended. D Venous/arterial thrombosis, diabetes Repeated admin. not advisable, consider long-term D Aspirin/NSAID induced allergies. Peptic with vascular involvement, severe hepatic disease, methods of contraception. Contains lactose. ulcer, other GI disorders. Pregnancy (1st and 3rd liver tumors, steroid influenced genital organ/ trimester). Pregnancy, lactation. breast malignancies, undiagnosed vaginal B Asthma, cardiac/renal/hepatic C Liver enzyme inducers e.g. anticonvulsants (phenobarbital, phenytoin, bleeding. Pregnancy. insufficiency. Elderly. primidone, carbamazepine), rifabutin, rifampicin, B Circulatory disorders, migraine, C Other analgesics. Caution: Oralgriseofulvin, ritonavir, St. John’s wort. hormone-dependent tumours, anticoagulants, thiazide diuretics. A Nausea, low abdominal pain, fatigue, hypertriglyceridemia, hypertension, Crohn’s A GI disturbances. Rash, pruritus. Easy headache, dizziness, breast tenderness, vomiting, disease, UC, vaginitis. Prolapse of uterine cervix, bruising or bleeding. Abnormal liver function AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
287
17.2 MENORRHAGIA
OBSTETRICS AND
tests.
FELDENE
BRUFEN RETARD
McNeil Healthcare
Abbott 2 M O
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. D Aspirin/anti-inflammatory induced allergy. Active peptic ulcer, history of recurrent ulceration. B Impaired renal or hepatic function, 2MO elderly. Intracranial haemorrhage and bleeding ALSO BRUFEN Ibuprofen 400mg, 600mg. Magenta diathesis. History of upper GI disease. Interstitial sug-ctd tab. marked BRUFEN 400, magenta oval nephritis, glomerulonephritis, papillary necrosis film-ctd tab. marked BRUFEN 600. 400mg-250, and nephrotic syndrome reported rarely. Monitor A11.45; 600mg-100, A7.28. patients with CHF, liver cirrhosis, nephrotic P 1200-1800mg daily in three divided syndrome, overt renal disease and in long term doses. Max. 2400mg daily. use. Pregnancy, lactation. Contains galactose. Q Not applicable. Perform ophthalmic evaluation if visual D Active peptic ulcer. complaints. B Aspirin/anti-inflammatory induced C Warfarin, heparin; not recommended. allergy. Asthma. Pregnancy. Caution: Oral anticoagulants, anti-hypertensives, C Caution: Antihypertensives, diuretics, diuretics, cardiac glycosides, lithium, methotrexate, cardiac glycosides, lithium, methotrexate, ciclosporin, NSAIDs, corticosteroids, cyclosporin, other NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycemics, anticoagulants, anti-platelet agents, SSRIs, other protein-bound drugs. quinolone antibiotics, probenacid, oral A GI disturbances, oedema, CNS effects, hypoglycaemics, Ginkgo biloba extracts. rash and pruritus. A Dyspepsia, GI bleeding, rash, rarely thrombocytopenia. MEFAC Rowex
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 fluid. In severe or acute conditions, max. 3 daily in two divided doses. Q Not applicable.
Solvay 2 M O
DUPHASTON 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.
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.
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 function. Haematuria in haemophilia. History of thromboembolic disease. Perform regular eye tests in patients with angioneurotic oedema. Rapid IV Chemidex infusion may cause dizziness and/or hypertension. A GI upset. Colour vision disturbance.
Fenamate. 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 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 and allergic disorders. C Anticoagulants. A Diarrhoea, skin rash, headache, bronchospasm, GI disturbance. Renal impairment. Thrombocytopenia.
PONSTAN 2MO
NSAID. Mefenamic acid 250mg. Ivory/blue cap. marked PONSTAN 250. 100, A5.70; 500, A25.61.
DECAPEPTYL SR
Ipsen
2MO
6NT
ALSO PONSTAN FORTE Mefenamic acid 500mg. Yellow film-ctd tab. 100, A10.40. S Primary dysmenorrhoea. Pre-menstrual syndrome.
Gn-RH analogue. Triptorelin 3mg. 5ml vial containing powder plus 2ml diluent. 1, A157.61. S Uterine fibromyomas. P 1 vial (3mg) as single IM inj. every 28 days. Start in to 5 days of cycle. See SPC. Q Not applicable. D Pregnancy. B See SPC. A Hot flushes, vaginal dryness, loss of libido, rash, hair loss, asthenia, headache. See SPC.
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
288
GYNAECOLOGY
DUPHASTON
Solvay
2NO Progestogen. Dydrogesterone 10mg. White scored tab. marked S and 155. 42, A8.16. S Dysfunctional bleeding. P To arrest bleeding, 1 twice daily together with an oestrogen for 5-7 days. To prevent bleeding, 1 twice daily together with an
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
exceptionally severe headache, jaundice, marked increase of BP, hormone dependent neoplasia incl. breast cancer, history of thromboembolism, may GONAPEPTYL DEPOT Ferring affect glucose tolerance. Lactation. C Caution: Liver enzyme inducing drugs. 6NT A Weight gain, oedema, headache, lower Gn-RH analogue. Triptorelin (acetate) 3.75mg. abdominal pain, back pain, acne, vaginal Powder and solvent for inj. prolonged release in discharge, cervicitis, dysmenorrhea, mastalgia, pre-filled syringe 1, A183.98. breast tension, depression, mood changes, nausea, S Preoperative reduction of myoma size expulsion. to reduce bleeding and pain. P One syringe (3.75mg) by SC or deep IM PONALGIC Antigen inj. every 28 days, initiated in the first 5 days of 2MO cycle; change inj. site each time. Q Not applicable. NSAID. Mefenamic acid 250mg. Yellow/blue cap. D Osteoporosis. Pregnancy, lactation. marked ANTIGEN and coded MA250. 100, A4.67; B Careful diagnosis (e.g. laparoscopy). 500, A23.81. Supervening metrorrhagia during treatment is 2MO abnormal (apart from 1st month); check oestrogen ALSO PONALGIC FORTE TABLETS Mefenamic acid level if occurs (see SPC). Use non-hormonal 500mg. Yellow film-ctd tab. marked with logo and contraception during initial month of treatment. coded MA500. 100, A9.31. Uterine myomas: Determine size of uterus and S Mild to moderate pain incl. headache, myoma regularly (see SPC). Decrease of bone dental or post-op pain, rheumatic, muscular or density, allergic and anaphylactic reactions arthritic pain. Primary dysmenorrhoea. reported. Dysfunctional menorrhagia. C Oestrogen. P 500mg three times daily. A Bone pain, libido decreased, hot flushes, Q Not recommended. mood changes, headache, vaginal disorders, D Ulcerative lesions or inflammation of GI perspiration. Hypersensitivity, depressive mood, tract. Renal or hepatic impairment. Pregnancy, irritability, nausea, myalgia, arthralgia, tiredness, lactation. Aspirin/NSAID induced bronchospasm, sleep disorders, inj. site pain/reaction. rhinitis or urticaria. B Elderly. Renal dysfunction. Regular MIRENA Bayer Schering surveillence if therapy is prolonged. Discontinue if liver dysfunction, rash, blood dyscrasias or 2NO diarrhoea occur. Cardiac or hepatic impairment. IUS. Levonorgestrel 52mg. T-shaped intrauterine History of peptic ulcer or inflamatory bowel A system. 1, 107.88. disease. Intracranial haemorrhage or bleeding S Idiopathic menorrhagia. diathesis. P To be inserted into the uterine cavity C Anticoagulants, other plasma protein within 7 days of the onset of menstruation. Replace after 5 years. Delay post-partum use until bound drugs. Antihypertensives, diuretics, cardiacglycosides, lithium, methotrexate, 6 weeks after delivery. D Pregnancy, pelvic inflammatory disease, cyclosporin, other NSAIDs, corticosteroids, aminoglycosides, probenecid, oral hypoglycaemics. postpartum endometritis, infected miscarriage A GI disturbance, diarhoea, headache, (past 3 months), cervicitis, cervical dysplasia, bronchospasm, rash, renal dysfunction, uterine or cervical malignancy, undiagnosed thrombocytopenia and other blood dyscrasias. genital bleeding, uterine anomaly, genital infection, acute liver tumour, severe hepatic PONSTAN Chemidex disease, progestogen-dependent tumours. 2MO B Severe arterial disease, migraine, oestrogen from day 11 to 25 of the cycle. D See section 17.1.
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.
MENORRHAGIA 17.2 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 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.
PRIMOLUT N
Bayer Schering
2NO Progestogen. Norethisterone 5mg. White tab. marked AN in a hexagon. 30, A3.21; 100, A10.71. S Dysfunctional bleeding, endometriosis. 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. B Diabetes, epilepsy, migraine, asthma, hypertension, cardiac dysfunction. A Liver disturbances, nausea, hypersensitivity reactions.
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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
289
17.3 ENDOMETRIOSIS
OBSTETRICS AND
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.
17.3 ENDOMETRIOSIS
DECAPEPTYL SR
Ipsen
6NT Gn-RH analogue. Triptorelin 3mg. 5ml vial containing powder plus 2ml diluent. 1, A157.61. S Endometriosis. P 1 vial (3mg) as single IM inj. every 28 days. Start in first 5 days of cycle. See SPC. Q Not applicable.
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. Start in first five days of cycle. See SPC. Q Not applicable. D Pregnancy B See SPC. A Hot flushes, vaginal dryness, decrased libido, rash, hair loss, asthenia, headache, transient hypertension, transient sight disturbances may occur. See SPC.
290
DUPHASTON
Solvay
2NO
GYNAECOLOGY
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. GONAPEPTYL DEPOT Ferring B Diabetics (monitor blood glucose). 6NT Regular menstruation, fibroids (confirm diagnosis), ovarian mass (exclude prior to treatment), Gn-RH analogue. Triptorelin 3.75mg. Powder and increased uterine cervical resistance, major risk solvent for inj. prolonged release in pre-filled factors for decreased bone mineral content. syringe. 1, A183.98. Hepatic dysfunction and jaundice reported; close S Symptomatic endometriosis. P One syringe (3.75mg) by SC or deep IM observation. Spinal fracture, paralysis, hypotension and worsening of depression have been reported. inj. every 28 days, initiated in the first 5 days of A Oedema, hypertension, palpitations, cycle; change inj, site each time. fatigue, muscle weakness, GI upsets, headache, Q Not applicable. bone/muscle pain, dizziness, insomnia, liver D Osteoporosis. Pregnancy, lactation. function test increases, inj. site reactions, changes B Careful diagnosis (e.g. laparoscopy). in blood lipids/glucose. Hot flushes, depression, Supervening metrorrhagia during treatment is abnormal (apart from 1st month); check oestrogen vaginal dryness. level if occurs (see SPC). Use non-hormonal PROVERA Pharmacia contraception during initial month of treatment. Uterine myomas: Determine size of uterus and 2NO myoma regularly (see SPC). Decrease of bone Progestogen. Medroxyprogesterone acetate 2.5mg, density, allergic and anaphylactic reactions 5mg, 10mg. Orange scored tab. marked U64, blue reported. scored tab. marked 286 and white scored tab. C Oestrogen. marked UPJOHN 50. 2.5mg-30, A2.18; 5mg-30, A Bone pain, libido decreased, hot flushes, A4.43; 5mg-100, A14.75; 10mg-90, A27.51. mood changes, headache, vaginal disorders, S Dysfunctional (anovulatory) uterine perspiration. Hypersensitivity, depressive mood, bleeding.Mild to moderate irritability, nausea, myalgia, arthralgia, tiredness, endometriosis.Secondary amenorrhoea. sleep disorders, inj. site pain/reaction. P Endometriosis: 10mg three times daily starting on the first day of cycle for 90 consecutive PRIMOLUT N Bayer Schering days. Dysfunctional uterine bleeding: 2.5-10mg 2NO daily for 5-10 days commencing day 16-21 of cycle Progestogen. Norethisterone 5mg. White tab. and given for 2 consecutive cycles. Secondary marked AN in a hexagon. 30, A3.21; 100, A10.71. amenorrhea: 2.5-10mg daily for 5-10 days S Dysfunctional bleeding, endometriosis. commencing day 16-21 of cycle and repeated for 3 P Dysfunctional bleeding, 1 three times consecutive cycles. daily over 10 days. To prevent recurrence, admin. Q Not applicable. prophylactically during next 3 cycles (1 twice or D History of thromboembolic disorders. three times daily from day 19-26). Endometriosis, 1 Liver dysfunction, pregnancy. twice daily starting on day 5 increasing to 2 twice B History of depression, diabetes, epilepsy, daily if spotting occurs. Continue with initial dose migrane, asthma, cardiac or renal dysfunction. for 4-6 months. C Aminoglutethimide. Q Not applicable. A Thromboembolic disorders, insomnia, D Pregnancy, liver dysfunction. History fatigue, rash, weight gain. during pregnancy of general pruritus or idiopathic SUPRECUR sanofi-aventis jaundice, Dubin-Johnson and Rotor syndromes, history of thromboembolic disorders. 6NO B Diabetes, epilepsy, migraine, asthma, LH-RH analogue. Buserelin 150mcg (acetate) per hypertension, cardiac dysfunction. dose; nasal spray. 2 x 10g with nebuliser type A Liver disturbances, nausea, metered dose pump, A90.79. hypersensitivity reactions. S Endometriosis in cases that do not require surgery or primary therapy. PROSTAP SR Takeda P Women over 18 years, 1 application in 6NT each nostril in the morning, at midday and in the LHRH analogue. Leuprorelin acetate 3.75mg. evening for a max. 6 months. Start therapy on Powder and 1ml solvent for prolonged-release first or second day of cycle. suspension for inj. 1, A163.01. Q Not applicable. S Management of oestrogen dependent D Post menopausal women, pregnancy, gynaecological disorders: pain/lesions associated lactation. Undiagnosed vaginal bleeding, hormone with endometriosis, uterine fibroids to reduce size dependant neoplasms. and associated bleeding (preoperative), B Pregnancy test if there is a possibility of endometrial preparation prior to intrauterine pregnancy. Impaired renal or liver function. surgery (endometrial ablation/resection). C Oral contraceptives. P 3.75mg admin. by SC or IM inj. once A Menopause like symptoms and monthly. Initiate during days 3-5 of menstrual withdrawal bleeding, bone mineral loss with cycle. Max. 6 months. Co-admin. with HRT: prolonged use. Recovery of HPG function usually treatment up to 12 months for chronic occurs within 8 weeks of discontinuing treatment. 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.
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
BREAST DISORDERS 17.4
AND GYNAECOLOGY
SYNAREL NASAL SPRAY
Pharmacia
6NT GnRH analogue. Nafarelin (as acetate) 2mg/ml; Clear, colourless to slightly yellow nasal spray soln. 200mcg per metered spray soln. 60 dose unit, A79.36. S Endometriosis. P 1 spray (200mcg) twice daily as one spray to one nostril in the morning and 1 spray in the other nostril in the evening. Initiate treatment between days 2 and 4 of the menstrual cycle. The recommended duration of treatment is 6 months. Do not retreat. Q Not applicable. D Hormone dependent neoplasms. Pregnancy, lactation. Undiagnosed vaginal
bleeding. B Missed doses potential for conception. A Hot flushes, vaginal dryness, headache, changes in libido, emotional lability, myalgia, decreased breast size, irritation of nasal mucosa, small reduction in bone density.
ZOLADEX
AstraZeneca
6NT GnRH analogue. Goserelin 3.6mg in a biodegradable depot. Single-dose syringe applicator. 1 (month course), A159.50. S Endometriosis. P Initial treatment should be in hospital. One 3.6mg depot SC inj. into anterior abdominal wall every 28 days for max. 6 months. Q Not applicable.
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.
D Pregnancy; non-hormonal methods of contraception should be used throughout treatment. Lactation. B Patients at risk of osteoporosis. A Hot flushes, loss of libido, headaches, mood changes and vaginal dryness, change in breast size, rashes.
17.4 BREAST DISORDERS
ARIMIDEX
AstraZeneca
5NO Aromatase inhibitor. Anastrozole 1mg. White biconvex film-ctd. tab. embossed with logo on one side and strength on reverse. 28, A89.08. S Treatment of early breast cancer in hormone receptive post-menopausal women. Treatment of advanced breast cancer in post menopausal women. P 1mg once daily. No dose change in renal or hepatic impairment. Q Not recommended. D Pregnancy, lactation. B Children/pre-menopausal women (safety 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.
AROMASIN
Pharmacia
5NO Irreversible aromatase inhibitor. Exemestane 25mg. Round, biconvex, white ctd tab. marked 7663. 30, A135.00. S Adjuvant treatment of post-menopausal women with oestrogen receptor positive invasive early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy. Advanced breast cancer in post-menopausal women where disease has progressed following anti-oestrogen therapy. P 1 daily preferably after meal. Early breast cancer, continue until completion of 5 years sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) or tumour relapse. Advanced, continue until tumour progression. Q Not recommended. D Pre-menopausal women. Pregnancy, lactation. B Caution: Hepatic/ renal impairment; osteoporosis (or at risk of), assess bone mineral density before use. Contains sucrose, methyl-phydroxybenzoate. Hepatitis/ cholestatic hepatitis reported. C Oestrogen-containing drugs (contra). CYP3A4 substrates and inducers (caution). A Anorexia, hot flushes, depression, headache, GI disorders, fatigue, sweating, rash, alopecia, joint/ musculoskeletal pain, dizziness, carpal tunnel syndrome, pain, peripheral oedema.
DOSTINEX
Pharmacia
2NO Dopamine agonist. Cabergoline 0.5mg. White capsule shaped flat scored tabs. marked P and U on one face and 700 on the other. 8, A34.01. S Hyperprolactinaemic disorders incl. amenorrhoea, oligomenorrhoea, anovulation and
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
291
17.4 BREAST
OBSTETRICS AND
DISORDERS
galactorrhoea. Prolactin secreting pituitary adenomas, empty sella syndrome with associated idiopathic hyperprolactinaemia and idiopathic hyperprolactinoma. P Initially 1 tab. per week in one or two doses. If necessary, increase gradually by 1 tab. per week at monthly intervals. Usual maintenance dose 2 tabs. per week in single or divided doses; max. 9 tabs. per week. Tabs. should be taken with food. Q Not recommended. D Hypersensitivity to ergot alkaloids. Hepatic insufficiency, toxaemia of pregnancy. Lactation. Do not co-administer with antipsychotics. B Evaluate pituitary prior to treatment. Renal, hepatic or cardiac disease, Raynaudâ&#x20AC;&#x2122;s syndrome, GI ulceration or bleeding. Psychotic 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.
292
GYNAECOLOGY
S Treatment of patients with metastatic breast cancer whose tumours overexpress HER2 (see SPC). Treatment of HER2 positive early breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy. P Initial loading dose: 4mg/kg body 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 FARESTON Orion subsequent inf. for symptoms (fever, chills, other infusion-related symptoms). Interruption of inf. 5MO may help control such symptoms, inf. may be Anti-oestrogen. Toremifene 60mg. White tab. resumed when symptoms abate. marked TO60. 30, A34.31. Q Under 18 years, not recommended. S First line hormone treatment of D Severe dyspnoea at rest due to hormone dependent metastatic breast cancer in complications of advanced malignancy or postmenopausal patients. requiring supplementary oxygen therapy. P 1 daily Lactation. Q Not applicable. B Monitor for cardiotoxicity and inf. D Pre-existing endometrial hyperplasia, severe hepatic failure, QT prolongation, electrolyte reactions. Pulmonary events (dyspnoea, bronchospasm, asthma, hypoxia) can occur as part disturbances (eg. hypokalaemia), bradycardia, heart failure with reduced left-ventricular ejection of inf. reaction. Pregnancy. A Fever, chills, abdominal pain, asthenia, fraction, history of symptomatic arrhythmias. chest pain, headache, diarrhoea, nausea, vomiting, Pregnancy, lactation. anorexia, constipation, dyspepsia, dry mouth, B Proarrhythmic conditions (especially in arthralgia, myalgia, rash, allergic reaction, elderly) eg. acute myocardial ischaemia or QT infection, pain, vasodilation, tachycardia, prolongation; monitor for cardiac arrhythmia hypotension, heart failure, cardiomyopathy, (discontinue if occurs). Non-compensated cardiac palpitation, leucopenia, peripheral oedema, leg insufficiency, severe angina, bone metastases, severe thromboembolic disease (avoid), additional cramps, arthritis, anxiety, depression, dizziness, insomnia, asthma, cough, UTI. risk of endometrial cancer, liver impairment. C Contra: Drugs prolonging QT interval. MEGACE BMS Avoid warfarin-type anticoagulants. Caution: 2NO Thiazide diuretics, enzyme inducers (eg. phenobarbital, phenytoin and carbamazepine), Progestogen. Megestrol acetate 160mg. Off-white CYP3A4 inhibitors (see annexe). oval scored tab. marked 160. 160mg-30, A34.10. A Hot flushes, depression, sweating, rash, S Certain hormone dependent neoplasms nausea, vomiting, leukorrhoea, dizziness, oedema, (e.g. endometrial or breast carcinoma). Cachexia: uterine bleeding, fatigue. See Megace Oral Suspension section 20.1. P Breast carcinoma, 160mg daily in single FEMARA Novartis or divided doses for min. period of 2 months. Endometrial, see 20.1. 5NO Q Not applicable. Aromatase inhibitor. Letrozole 2.5mg. Yellow round coated tab. marked FV on one side and CG D Pregnancy, lactation. B Thrombophlebitis. on reverse. 30, A93.26. A Weight gain, nausea, vomiting, oedema, S Extended adjuvant treatment of breakthrough uterine bleeding, urticaria. hormone dependent early breast cancer in postmenopausal women having received 5 years NOLVADEX-D AstraZeneca of tamoxifen therapy. Treatment of hormone 5MO dependent advanced breast cancer in postAnti-oestrogen. Tamoxifen (citrate) 20mg. White menopausal women (1st line or after relapse/ octagonal film-ctd tab. marked NOLVADEX-D. 30, progression with antiestrogens). A7.23. P 1 daily. Q Not applicable. S Breast cancer. D Premenopausal endocrine status. P 20-40mg daily; as single dose or divided Pregnancy, lactation. in 2. B Severe renal or hepatic impairment. If Q Not recommended. risk of osteoporosis, assess BMD and monitor. D Pregnancy, lactation. C Caution: CYP2A6 and 2C19 substrates B Increased incidence of endometrial with narrow therapeutic index. cancer, uterine sarcoma. Second primary tumours A Increased sweating, hot flushes, fatigue, reported. Contains lactose. weight increase, appetite change, C Caution: Coumarin-type anticoagulants, hypercholesterolaemia, headache, dizziness, GI cytotoxic agents. CYP3A4 inducers, CYP2D6 disorders, alopecia, rash, oedema, myalgia, bone inhibitors. pain, arthralgia, arthritis, osteoporosis, bone A Hot flushes, thrombolitic/ fractures. cerebrovascular events, vaginal bleeding/discharge, pruritus vulvae, endometrial changes, GI distress, HERCEPTIN Roche dizziness, fluid retention, headache, rash, alopecia, tumour flare, leg cramps. 2N Monoclonal antibody. Trastuzumab 150mg. PARLODEL Meda Powder for soln. for inf. in vial. 1 vial. Price on 2MO request. disorders. Monitor gynaecological changes. Discontinue at least 1 month before trying to conceive. Use mechanical contraception if conception is not desired. See SPC. C Long-term ergot alkaloids, dopamine agonists, dopamine antagonists, macrolide antibiotics, anti-psychotics. A Nausea, headache, dizziness, abdominal pain, fatigue, constipation, vomiting, breast pain, hot flushes, depression, paresthesia.
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
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.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 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 agents, drugs effecting BP. A Postural hypotension, nausea, vomiting, mild constipation, dry mouth, leg cramps, vasospasm, hypertension, MI, strokes, drowsiness, confusion, hallucinations, headache, dizziness, seizures, episodes of reversible pallor of fingers and toea induced by cold, psychomotor exitation, dyskinesia, retroperitoneal fibrosis.
TAMOX
Rowex
5MO Anti-oestrogen. Tamoxifen (citrate) 10mg, 20mg. White film-ctd tabs. 10mg-30, A6.08; 20mg-30, A7.21. S Palliative management of breast cancer. P 20-40mg once daily. Q Not applicable. D Pregnancy. B Lactation. Contains lactose. C Coumarin-type anticoagulants, cytotoxic agents (increased risk of thromboembolic events). A Hot flushes, vaginal bleeding/discharge, pruritus vulvae, GI intolerance, dizziness, tumour flare, visual disturbances, skin rash, pulmonary embolism.
ZOLADEX
AstraZeneca
6NT GnRH. Goserelin (acetate) 3.6mg in a biodegradable depot. Single-dose syringe applicator. 1 (month course), A159.50. S Breast cancer in pre and perimenopausal women suitable for hormone manipulations. P One 3.6mg depot SC inj. into anterior abdominal wall every 28 days. Q Not applicable. D Pregnancy, lactation. A Hot flushes, decreased libido, breast swelling and tenderness, rashes, headache,
MENOPAUSAL DISORDERS,
OSTEOPOROSIS
17.5
emotional lability, vaginal dryness, hypercalcaemia. metabolism first. Mild to moderate renal impairment, history of absorptive or renal 17.5 MENOPAUSAL DISORDERS, hypercalciuria, nephrocalcinosis, kidney stone formation, hypophosphataemia; monitor renal OSTEOPOROSIS function, serum and urinary Ca++ and phosphate. ACLASTA Novartis Contains lactose. C Caution: Products containing polyvalent 2JN cations, thiazide diuretics, systemic corticosteroids, Bisphosphonate. Zoledronic acid anhydrous 5mg/ cardiac glycosides, bisphosphonates or Na+ A 100ml. Soln for inf. 100ml, 499.84. fluoride, tetracycline, oxalic acid, phytic acid. S Osteoporosis in post-menopausal A Headache, GI disorders, musculoskeletal women and in men at increased risk of fracture pain. including those with recent low-trauma hip fracture. Osteoporosis associated with long-term ACTONEL ONCE A WEEK P & GP/ systemic glucocorticoid therapy. sanofi aventis P Once a year IV inf. of 5mg in 100ml soln over at least 15 min, admin. via vented inf. line at 2 N O + constant inf. rate. Bisphosphonate. Risedronate (Na ) 35mg. Oval D Hypocalcaemia. Pregnancy, lactation. light-orange film-ctd tab. marked RSN one side, B Severe renal impairment (avoid). Ensure 35mg on reverse. 4, A30.84. adequate hydration. Treat disturbances of mineral S Treatment of postmenopausal metabolism first. Vit D intake recommended osteoporosis, to reduce the risk of vertebral following inf. Ensure adequate Ca++ suppl. (at least fractures. Treatment of established 500mg Ca++ twice daily for min. 10 days following postmenopausal osteoporosis, to reduce the risk of inf). Monitor for symptoms of hypocalcaemia. hip fractures. C Caution: Drugs impacting renal function P 35mg once weekly taken 30 mins. (e.g. aminoglycosides, diuretics). before the first food, other medicines or drink A Flu-like symptoms, hypocalcaemia, (except water) of the day, on the same day each headache, lethargy, dyspnoea, diarrhoea, nausea, week and swallowed whole. dyspepsia, bone pain, arthralgia, myalgia, pyrexia, Q Not recommended. rigors, fatigue, pain, asthenia. 2NO ALSO ACTONEL Risedronate (Na+) 5mg. Yellow ACTIVELLE Novo Nordisk oval film-ctd tab. marked RSN on one side and 2NO 5mg on reverse. 28, A28.34. S Treatment of postmenopausal Oestrogen/progestogen (continuous combined). osteoporosis to reduce the risk of vertebral Estradiol (hemihydrate) 1.03mg (equiv. to anhydrous estradiol 1mg), norethisterone (acetate) fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of 0.5mg. White film-ctd tab. 28, A11.20. S HRT for oestrogen deficiency symptoms hip fractured. Prevention of osteoporosis in in women more than 1 year after menopause with postmenopausal women with increased risk of osteoporosis. To maintain or increase bone mass in an intact uterus. Prevention of osteoporosis in postmenopausal women undergoing long-term post menopausal women. systemic corticosteroid therapy. P 1 daily without break starting at P 5mg daily. Tab. should be swallowed anytime if not menstruating or if transferring from other continuous combined HRT products. In whole in an upright position, with a glass of water, at least 30 mins. before the first food or women transferring from sequential regimens drink of the day or at least 2 hours from any start right after withdrawal bleeding has ended. other food or drink at other times and at least 30 Q Not applicable. mins. before retiring. D See SPC. Q Not recommended. ACTONEL COMBI sanofi-aventis D Hypocalcaemia, severe renal impairment (Q30ml/min). Pregnancy, lactation. 2NO B Caution: History of oesophageal Bisphosphonate/Ca++. Risedronate Na+ 35mg disorders (e.g. stricture, achalasia), patients unable (equiv. risedronic acid 32.5mg), Ca++ carbonate to stay in upright position for at least 30 min, 1250mg (equiv. Ca++ 500mg). Film-ctd tabs. active or recent oesophageal or upper GI Risedronate Na+, oval, light-orange with RSN on problems, disturbance of bone and mineral one side and 35mg on reverse; Ca++, caps.-shaped, metabolism. Hypocalcaemia, inadequate dietary blue with NE 2 on both sides. 1 Actonel and 6 intake of Ca++ and vit. D. Ca++, A34.86. C Medications containing Ca++, S Postmenopausal osteoporosis, to reduce magnesium, iron, alum. risk of vertebral/hip fractures. A GI disturbance, musculoskeletal pain, P 1 Actonel 35mg tab. on 1st day with headache. water at least 30 min before 1st food of the day, followed on the next day by 1 Ca++ tab. daily for 6 ACTONEL PLUS Ca & D P & GP/ days taken with meal. Repeat this 7 day sequence sanofi aventis each week. Take Actonel 35mg in upright position 2MO and do not lie down for 30 min. Bisphosphonate/Ca++/vit D3. Tabs. contain D Hypocalcaemia, hypercalcaemia, risedronate Na+ 35mg (equiv. 32.5mg risedronic hypercalciuria, nephrolithiasis, severe renal acid). Effervescent granules contain Ca++ carbonate impairment. Pregnancy, lactation. 2500mg (equiv. Ca++ 1000mg and colecalciferol B Caution: History of oesophageal disorders (e.g. stricture, achalasia), patients unable (vit. D3) 22mcg (880 IU)). Oval, light-orange, filmctd tab. with RSN on one side and 35mg on to stay in upright position for at least 30 min, reverse. White effervescent granules. 4 tabs and active or recent oesophageal or upper GI problems. Treat disturbances of bone and mineral 24 sachets, A32.05.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
293
17.5 MENOPAUSAL
DISORDERS, OSTEOPOROSIS
S Postmenopausal osteoporosis, to reduce risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce risk of hip fractures. P 1 tab on day 1 followed the next day by 1 sachet daily for 6 days. Repeat 7 day sequence each week. Swallow tab whole on the same day each week with water 30 min before 1st food, other medicinal product or other drink. Do not lie down until 30 min after taking tab. D Hypocalcaemia, hypercalcemia, hypercalciuria. Diseases and/or conditions associated with hypercalcaemia/hypercalciuria. Nephrolithiasis. Pregnancy, lactation. Severe renal impairment. Hypervitaminosis D. B Caution: Very elderly, 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. Correct disturbances of bone/ mineral metabolism before treatment. Osteonecrosis of the jaw reported; consider dental examination with appropriate preventive dentistry prior to treatment in at risk patients. Avoid invasive dental procedures while on treatment. Monitor renal function, serum and urinary Ca++ and phosphate regularly in patients with mildmoderate renal impairment, or history of absorptive or renal hypercalciuris, nephrocalcinosis, kidney stone formation, or hypohosphataemia. Long term treatment (monitor). Use with other 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
OBSTETRICS AND
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
Drug Prescribing Notes ● ALENDRONATE Contraindications Abnormalities of the oesophagus and other factors which delay oesophageal emptying, such as stricture or achalasia ● Inability to stand or sit upright for at least 30 minutes ● Hypocalcaemia. Special Precautions Not recommended for renally insufficient patients (cc< 35ml/min) ● Causes of osteoporosis other than oestrogen deficiency and ageing should be considered ● May cause local irritation of mucous membranes in upper GI tract ● Caution: Existing active upper GI problems (dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, barrett’s oesophagus) ● Warn patients of side effects (sometimes severe and requiring hospitalisation) in the oesophagus (oesophagitis, oesophageal ulcer, oesophageal erosion, rarely followed by oesophageal stricture). Patients should discontinue and report symptoms of oesophageal irritation such as dysphagia, pain when swallowing, retrosternal pain, new or intensified heartburn. Greater risk in patients not taking dose correctly or continuing treatment despite symptoms ● Rare cases of gastric and duodenal ulcers (some severe and with complications) ● Treat hypocalcaemia and other disturbances of mineral metabolism (e.g. vitamin D deficiency and hypoparathyroidism) before initiating treatment ● Symptomatic hypocalcaemia reported rarely; severe cases in patients with an underlying predispose condition (e.g. hypoparathyroidism, vitamin D deficiency or calcium malabsorption) ● Ensure sufficient intake of calcium and vitamin D in patients receiving glucocorticoids ● Osteonecrosis of the jaw reported. Dental examination with appropriate preventive dentistry should be considered prior to treatment in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, periodontal disease). Avoid invasive dental procedures if possible ● Femoral stress fractures may occur (long-term treatment). Pregnancy: No adequate data. Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/ fetal development, or postnatal development. Alendronate given during pregnancy in rats caused dystocia related to hypocalcemia. Given the indication, alendronate should not be used during pregnancy. Lactation: It is not known whether alendronate is excreted into human breast milk. Given the indication, alendronate should not be used by breast-feeding women. Drug Interactions Wait at least 30 min after taking alendronate before taking any other oral product (Ca++ supps, antacids). Side-Effects Headache, GI upset, oesophageal ulcer, dysphagia, abdominal distension/pain, acid regurgitation, musculoskeletal pain. Revised November 2009
294
GYNAECOLOGY
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. John’s wort, aldosterone antagonists or K+-sparing diuretics. A Abdominal pain or bloating, asthenia, pain in extremity, nausea, headache, mood swings, hot flushes, nervousness. Uterine fibroids enlarged, cervix neoplasm, leukorrhea, breakthrough bleeding, benign breast neoplasms, breast enlargement.
BONVIVA
Roche
2NO Bisphosphonate. Ibandronic acid (as Na+ monohydrate) 150mg. White, oblong, film-ctd tab. marked BNVA on one side and 150 on reverse. 1, A27.73. S Osteoporosis in postmenopausal women at increased risk of fractures. Demonstrated efficacy on vertebral fractures; efficacy on femoral neck fractures not established. P 1 monthly on same date each month after overnight fast (at least 6 hrs) and 1 hr before 1st food, other drug or drink of day. Swallow whole in upright position and do not lie down for 1 hr. Q Children and adolescents, not recommended.
2J ALSO BONVIVA IV Ibandronic acid (as Na+ monohydrate) 3mg. Pre-filled syringe. 3ml, A103.89. P 3mg as an IV inj. over 15-30 sec every 3 months. Q Children and adolescents, not recommended. D Hypocalcaemia, renal impairment (ccQ30ml/min). B Treat hypocalcaemia and disturbances of bone and mineral metabolism first. Ensure adequate Ca++ and vit. D intake. Osteonecrosis of the jaw has been reported; consider dental examination in patients at risk. Tab: History of prolonged oesophageal transit time. Discontinue if oesophageal reaction occurs. C Tab: Products containing Ca++ and other multivalent cations (e.g. alum., magn., iron). A GI disturbances, flu-like illness, fatigue, myalgia, arthralgia. Rash (IV).
CALCICHEW D3 FORTE
Shire
2O 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.
2
5
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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
OBSTETRICS
AND GYNAECOLOGY
MENOPAUSAL DISORDERS,
trunk or buttocks. Do not apply on or near the breasts or use unopposed estrogen (except after hysterectomy). If a progestogen is necessary, use at least for 12-14 days each month. Continuous 2O use: Apply weekly. ALSO CALCICHEW Ca++ carb. 1.25g (equiv. Ca++ Q Not applicable. 500mg). White chewable tab. 100, A13.49. D Current or past breast cancer, oestrogen P 2-6 daily. dependent malignant tumours, undiagnosed Q Not applicable. genital bleeding, untreated endometrial D Hypercalcaemia, hypercalciuria. hyperplasia, previous idiopathic or current venous C Tetracyclines, fluoride, iron, cardiac thromboembolism, active or recent arterial glycosides, thiazide diuretics. thromboembolic disease (e.g. angina, MI), acute or A Mild GI disturbance, hypercalcaemia. past liver disease, as long as liver function tests CALTRATE Wyeth Healthcare have failed to return to normal, porphyria. Pregnancy, lactation. 2OY B Uterine fibroids or endometriosis, risk Calcium/vit. D suppl. Ca++ (as carbonate) 600mg, factors for thromboembolic disorders or oestrogen cholecalciferol 10mcg (eq. to 400 I.U. vit. D3). Cap.dependent tumours, hypertension, liver disorders, shaped grey/beige tab. scored on 1 side and diabetes mellitus with or without vascular engraved with D 600 on each side of score. Other involvement, cholelithiasis, migraine or severe side is engraved with Caltrate. 90, A7.84. headache, systemic lupus erythematosus, history of S Correction of combined vit. D and Ca++ endometrial hyperplasia, epilepsy, asthma, deficiencies in the elderly. Supply of vit. D and otosclerosis. Discontinue if: Jaundice, BP increase, Ca++ as adjunct to specific treatments for migraine onset. osteoporosis, in patients with diagnosed or at C Inducers of P450 enzymes, ritonavir, high risk of combined vit. D and Ca++ deficiencies. nelfinavir, St.John’s wort. P 1 tab. twice a day with a large glass of A Pain, flatulence, nausea, oedema, water. Pregnant women: 1 tab. a day. weight gain, depression, dizziness, nervousness, Q Not recommended. lethargy, headache, sweating, pruritus, rash, D Renal failure. Hypercalciuria and menstrual disorder, vulva/ vagina disorder. hypercalcaemia and diseases / conditions leading to hypercalcaemia and/or hypercalciuria (e.g. DIDRONEL PMO P & GP myeloma, bone metastases, primary 2MO hyperparathyroidism). Kidney stones (nephrolitiasis, nephrocalcinosis). Hypervitaminosis Bisphosphonate. Etidronate disodium 400mg and Ca++ carb. 1250mg. 14 Didronel tabs (white cap. D. Soya/peanut hypersensitivity. shaped tabs marked NE and 406) and 76 Cacit tabs B Caution: Prolonged treatment, (pink, orange flavoured, efferv.) resp. 1 x 3 month immobilised patients, sarcoidosis, decreased renal pack, A51.92; (A17.31 per month). function. Reduce or interrupt treatment S Treatment of osteoporosis and temporarily if urine Ca++ q 7.5mmol/24h (300mg/ prevention of bone loss in post menopausal 24h). Pregnancy, lactation. Contains sucrose. women considered at risk of developing C Caution: Thiazide diuretics, systemic osteoporosis. Patients who are unable or unwilling corticosteroids, orlistat, combined ion-exchange to take oestrogen replacement therapy. resin, paraffin, cardiac glycosides, phenytoin, Prevention and treatment of corticosteroid barbiturates. Absorption may be reduced by induced osteoporosis. Caltrate: Tetracycline, iron, zinc, strontium, P 1 Didronel 400mg tab. daily taken with estramustin, thyroid hormones, bisphosphonate, water in the middle of a 4 hour fast for 14 days, sodium fluoride, fluoroquinolone. Foods rich in followed by 1 Cacit tab. daily in water for 76 days. oxalic or phytic acid may inhibit absorption. Repeat 90 day cycle as required. CALVIDIN Ergha Q Not recommended. D Severe renal impairment. 2OY B Moderate renal impairment. Calcium/vit. D suppl. Ca++ carb. 1500mg (equiv. Enterocolitis. Pregnancy, lactation. Ca++ 600mg), cholecalciferol 4mg (equiv. vit. D3 A Nausea, diarrhoea. 10mcg/400 IU). White chewable scored tab. P 2 daily preferably 1 morning and evening. Q Not applicable.
OSTEOPOROSIS
17.5
tab. marked S and 155. 42, A8.16. S Adjunct to oppose oestrogen in HRT. P 1 daily for last 14 days of each cycle. Increasing if necessary to 1 twice daily. D See section 17.1.
ESTRADERM TTS
Novartis
2NO Oestrogen. Oestradiol 25 per 24 hours. Transdermal reservoir patches. 25mcg-8, A6.18. S Oestrogen replacement therapy for hysterectomised patients with menopausal 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. 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. Withdraw if: Jaundice or deterioration in liver function, significant increase in BP, new onset of migraine-type headache. May increase risk of endometrial hyperplasia, carcinoma, breast cancer, VTE, ovarian cancer. Contact sensitisation may occur. C CYP450 inducers, protease inhibitors, St. John’s wort. A Headache, migraine, GI disturbances.
ESTRADOT
Novartis
2NO
Oestrogen. Estradiol (as hemihydrate) 37.5mcg, 50mcg, 75mcg, 100mcg per 24 hours. Transdermal patches. 37.5mcg/24 hours-8, A6.27; 50mcg/24 hours-8, A7.00; 75mcg/24 hours-8, A8.37; 100mcg/ 24 hours-8, A8.37. S Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women. Prevention of postmenopausal osteoporosis in women with increased risk for future osteoporotic fractures. P Oestrogen deficiency symptoms: Initiate marked C/D. 60, A8.7451. DIVIGEL Orion usually with 50mcg/24 hours every 3-4 days (twice S As an adjunct to specific treatment for weekly) adjusting to individual needs. Prevention 2NO osteoporosis. of postmenopausal osteoporosis: Initiate with P 1-2 daily. Oestrogen. Oestradiol 0.1%. Gel. Sachets-28 x 1g, 50mcg/24 hours every 3-4 days (twice weekly), A8.64. Q Not recommended. adjust using 50, 75 and 100mcg strengths. D Hypercalcaemia, hypercalciuria. S HRT for climateric syndrome after Q Not applicable. C Tetracycline, fluoride, iron, cardiac natural or artificial menopause. Prevention of post D Oestrogen dependent tumours, glycosides, thiazide diuretics. menopausal osteoporosis. undiagnosed vaginal bleeding, untreated A Mild GI disturbances, hypercalcaemia. P 0.5-1.5mg daily used cyclically or endometrial hyperplasia, thromboembolic continuously. Normal starting dose 1mg daily. disorders, severe liver disease, porphyria. CLIMARA Berlipharm Apply once daily to the skin of lower trunk or Pregnancy, lactation. See SPC. thigh changing the application site daily (e.g. left B Migraine or severe headache, sudden 2NO Oestrogen. Estradiol 3.9mg (releasing 50mcg/day). and right sides alternate days) If uterus is intact, hearing loss, liver disorders, history or risk of also give a progestogen for 12 days of each cycle. thromboembolic disorders, leiomyoma, Transdermal patch. 4, A7.08. D See SPC. Do not apply to breasts, face, 2NO hypertension, diabetes mellitus with vascular ALSO CLIMARA FORTE Estradiol 7.8mg (releasing irritated skin or vaginal area. involvement, cholelithiasis, systemic lupus 100mcg/day). Transdermal patch. 4, A9.16. erythematosus, hyperplasia of endometrium, DUPHASTON Solvay S Oestrogen replacement therapy. cardiac or renal dysfunction, asthma, epilepsy, 2NO Prevention of postmenopausal osteoporosis. familial hypertriglyceridaemia. P Use lowest effective dose. Apply on the Progestogen. Dydrogesterone 10mg. White scored C Substances known to induce drugAAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
295
17.5 MENOPAUSAL
DISORDERS, OSTEOPOROSIS
OBSTETRICS AND
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, new onset of migraine-type headache, pregnancy. 2NO Not to be used for contraception. May increase Oestrogen. Estradiol 2mg. blue film-ctd tab. risk of endometrial hyperplasia, breast cancer, VTE, marked NOVO 280. Blue film-ctd tab. marked ovarian cancer. See SPC. NOVO 280. 28, A4.61. C CYP450 inducers, protease inhibitors, S Oestrogen deficiency symptoms due to steroids, St. John’s wort, lamotrigine. menopause or oophorectomy. Prevention of A Breast cancer, weight increase, osteoporosis. Women with a uterus, progestogen palpitations, nausea, rash, generalised and local must be considered. pain, breast pain, genital candidiasis, uterine P 1 daily without break in medication. If bleeding, application site erythema, irritation and clinical response is inadequate, dosage may be increased to 2 daily, reducing to 1 daily as soon as oedema. practicable. EVOREL CONTI Janssen-Cilag Q Not applicable. 2NO D See SPC. Oestrogen/progestogen (continuous combined). EVISTA Daiichi Sankyo Oestradiol hemihydrate 50mcg and norethisterone acetate 170mcg per 24 hours. Transdermal patch. 5MO 8, A17.00. Selective oestrogen receptor modulator (SERM). S HRT for relief of postmenopausal Raloxifene (HCl) 60mg. White elliptical film-ctd symptoms in post-menopausal women q 6 tab. marked 4165. 28, A25.41; 84, A76.22. months post-menopause. S Treatment and prevention of P Apply patch to clean, non-hairy area of osteoporosis in post menopausal women. skin below waist and replace with new patch P 1 daily, for long-term use. every 3-4 days using a different site. Q Not applicable. Q Not applicable. D Women with child-bearing potential, D Breast cancer, oestrogen dependent lactation. Prolonged immobilisation or history of venous thromboembolic events, hepatic or severe malignant tumours. Genital bleeding, untreated endometrial hyperplasia, thromboembolism, renal impairment, undiagnosed vaginal bleeding, thrombophlebitis. Arterial thromboembolic endometrial cancer. disease, acute liver disease (or history). Severe B Moderate and mild renal impairment. renal disease, porphyria. Pregnancy, lactation. History of oral oestrogen-induced B Leiomyoma or endometriosis, hypertriglyceridaemia. History of (or risk factors for) stroke. Safety in breast cancer not adequately thromboembolic disorders (history or risk factors for), risk factors for estrogen dependend tumours studied. Ensure adequate Ca++ and vit. D intake. (e.g. 1st degree heredity for breast Contains lactose. C Systemic oestrogens, not recommended. cancer),hypertension, liver disorders (e.g. liver adenoma), kidney disorders, diabetes mellitus Cholestyramine. (with or without vascular involvement), A Hot flushes, leg cramps, flu-syndrome, cholelithiasis, migraine or severe headache, SLE, peripheral oedema, venous thromboembolic epilepsy, asthma, hereditary or idiopathic events. angioedema, otosclerosis, mastopathy. Fluid EVOREL Janssen-Cilag retention: Observe in cardiac and renal dysfunction. Monitor patients with terminal renal 2NO insufficiency, pre-existing hypertriglyceridemia. Oestrogen. Oestradiol 50mcg per 24 hours. Immediate withdrawal: Jaundice or worsening Transdermal patch. 8, A8.37. liver function, increase BP, new onset of migraineS HRT for symptomatic relief of estrogen type headache, pregnancy. Not to be used for defiency. Osteoporosis prevention in contraception. May increase risk of endometrial postmenopausal women at high risk of fractures hyperplasia, breast cancer, VTE, ovarian cancer. intolerant of, or contraindicated for, other See SPC. C CYP450 inducers, protease inhibitors, medicines for osteoporosis prevention. P Apply patch to clean, non-hairy area of steroids, St. John’s wort, lamotrigine. A Weight increase, decreased libido, skin below waist and replace with new patch migraine, paraesthesia, hypertension, nausea, every 3-4 days using a different site. In nonpruritus, general and local pain, breast pain, hysterectomised patients give a progestogen for dysmenorrhoea incl lower abdominal pain, 12 days per month. See SPC. leukorrhoea, application site erythema/irritation/ Q Not applicable. oedema. D Breast cancer, oestrogen dependent malignant tumours. Genital bleeding, untreated FEMATAB Solvay endometrial hyperplasia, thromboembolism, thrombophlebitis. Arterial thromboembolic 2NO metabolising enzymes, specifically cytochrome P450 enzymes e.g. anticonvulsants (phenobarbital, phenytoin, carbamazepine), anti-infectives (rifampicin, rifabutin, nevirapine, efavirenz), ritonavir, nelfinavir, St. John’s Wort. A Depression, headache, nervousness, mood changes, insomnia, nausea, dyspepsia, diarrhoea, abdominal pain, application site reactions, erythema, itching, breast tension and pain, dysmenorrhoea, menstrual disorders, back pain, asthenia, peripheral oedema, weight changes.
296
GYNAECOLOGY
Oestrogen. Estradiol hemihydrate (equivalent to estradiol) 1mg, 2mg. White or brick-red resp., round, biconvex, film-ctd tab. marked with symbol on one side and 379 on the other. 1mg-28, A2.55; 2mg-28, A2.59. S HRT for estrogen deficiency symptoms in menopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures where other drugs are inappropriate. P 1mg daily, taken continuously, depending on response can increase to 2mg daily. Women with a uterus, admin. progestagen for 1214 days each month. Women transferring from cyclic/continuous sequential HRT regimen, begin treatment the day following completion of prior regimen. Start treatment within 5 days of the start of menses. Q Not applicable. D Non hysterectomized women without opposing progestogen, breast cancer, estrogendependent malignant tumours; undiagnosed genital bleeding; untreated endometrial hyperplasia; previous idiopathic/current venous thromboembolism; active/recent arterial thromboembolic disease (e.g. angina, MI, CVA); acute liver disease, or a history of liver disease 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.
FEMOSTON 2/10
Solvay
2NO Oestrogen/progestogen (sequential combined). Oestradiol 2mg (14 brick-red tabs); oestradiol 2mg, dydrogesterone 10mg (14 yellow tabs). Round, biconvex, film-ctd tabs. with 379 on one side and S on reverse. 28, A5.39. S Oestrogen deficiency symptoms in menopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures where other drugs are inappropriate. P 1 daily without break starting with brick-red tabs. Start by 5th day of menstruation if present or at any time if not. Q Under 18 years, not recommended. D Pregnancy, lactation. Current or past breast cancer, progesterone dependant neoplasma, estrogen-dependent malignant tumours, undiagnosed genital bleeding, endometrial hyperplasia, previous idiopathic or current venous thromboembolism, active or recent arterial thromboembolic disease, acute or past liver disease as long as liver function tests still abnormal, porphyria. B Conduct regular breast examinations. Caution: Leiomyoma or endometriosis, hypertension, liver disorders, diabetes mellitus, cholelithiasis, migraine, systemic lupus erythematosus, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis, cardiac or renal dysfunction, hypertriglyceridemia, surgery.
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
AND GYNAECOLOGY
FEMOSTON-CONTI 1/5
P 1 tab 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 at least 30 mins. after taking tab. Q Not recommended. D For other prescribing information, see alendronate Drug Presc. Notes.
FOSAMAX
MSD
Solvay 2 M O
2NO Oestrogen/progesteogen (continuous combined). Oestradiol 1mg, dydrogesterone 5mg. Salmon film-ctd tab. marked with logo one side, 379 on reverse. 28, A9.19. S Symptoms due to oestrogen deficiency in post menopausal woman more than 12 months after menopause with a uterus. Prophylaxis of postmenopausal osteoporosis in women with a uterus at risk of developing fractures. P 1 daily without break in medication. Q Not applicable. D See SPC.
Bisphosphonate. Alendronate Na+ (equiv. alendronic acid 10mg). White oval tab. marked 936. 28 (Cal/Pk), A27.74. S Treatment of osteoporosis in postmenopausal women and in men. P 1 daily. Swallow tab. upon rising with full glass of tap water, at least 30 mins. before food, drink or other oral medication. Remain upright for 30 mins. after dose. Q Not recommended.
2MO Bisphosphonate. Alendronic acid 70mg (as Na alendronate trihydrate). White to off-white, oval tab, embossed AN 70 on one side and logo on the other. 4, A22.91. S Postmenopausal osteoporosis; also reduces risk of vertebral or hip fractures.
17.5
2MO
ALSO FOSAMAX ONCE WEEKLY Alendronate Na+ trihydrate (equiv. alendronic acid 70mg). White oval tab. marked with an outline of a bone image FORSTEO Lilly one side, 31 on reverse. 4, A29.97. S Treatment of postmenopausal 2NT Parathyroid hormone. Teriparatide 750mcg (equiv. osteoporosis. Reduces the risk of vertebral and hip fractures. 250mcg/ml); 20mcg/dose. Colourless clear sln for P One 70mg tab. once weekly. Swallow at inj. in a 3ml pre-filled pen. 1, A454.58. S Osteoporosis in postmenopausal women least 30 mins. before first food, beverage, or medicinal product of the day with plain water and in men at increased risk of fracture (in postmenopausal women, demonstrated significant only. Remain upright for 30 mins. after dose. reduction of vertebral and non-vertebral fractures Q Not recommended. D For other prescribing information, see but not hip fractures). Osteoporosis associated alendronate Drug Presc. Notes. with sustained systemic glucocorticoid therapy in B Contains lactose. 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 patientâ&#x20AC;&#x2122;s lifetime. Q Not recommended. FOSAVANCE MSD D Pregnancy, lactation. Pre-existing 2MO hypercalcaemia. Severe renal impairment. Metabolic bone diseases (incl. Bisphosphonate. Alendronic acid (as alendronate hyperparathyroidism, Pagetâ&#x20AC;&#x2122;s disease of the bone) Na+ trihydrate) / colecalciferol (vit. D3) 70mg/70mcg other than primary osteoporosis or glucorticoid(2800 IU), 70mg/140mcg (5600 IU). White tabs. marked with bone image on one side. 70mg/2800 induced osteoporosis. Unexplained elevations of IU, cap.-shaped marked 710 on reverse. 70mg/5600 alkaline phosphatase. Prior external beam or IU, modified rectangle-shaped marked 270 on implant radiation therapy to skeleton. Skeletal reverse. 70mg/2800 IU-4, A29.44; 70mg/5600 IU-4, malignancies or bone metastases. A29.64. B Moderate renal impairment, active or recent urolithiasis. Any blood sampling should be S Postmenopausal osteoporosis in patients done at least 16 hrs after last Forsteo inj. at risk of vit. D insufficiency; reduces the risk of (elevations of serum Ca++). Limited experience in vertebral and hip fractures. younger adult population (pre-menopausal P 1 once weekly taken with plenty of women). Women of child-bearing age should use water (not mineral water) at least 30 mins. before contraception. Potential transient orthostatic 1st food/beverage or medicinal product of the hypotension; refrain from driving. day. Do not lie down until after 1st food which C Digitalis (caution). should be min. 30 mins. after taking tab. A Palpitations, anaemia, GI disorders, limb Q Children and adolescents, not pain, muscle cramps, headache, dizziness, sciatica, recommended. vertigo, dyspnoea, increased sweating, B Contains lactose and sucrose. For other hypercholesterolaemia, hypotension, fatigue, prescribing information, see alendronate Drug depression, inj. site reactions. Presc. Notes. C Olestra, mineral oils, orlistat, bile acid FOSALEN Pinewood sequestrants, anticonvulsants, cimetidine, thiazides. +
OSTEOPOROSIS
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,
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AAdverse Reaction â&#x20AC;˘ DContraindications â&#x20AC;˘ BSpecial precautions â&#x20AC;˘ CDrug interactions
Discontinue if: Jaundice or deterioration in liver function, significant increase in BP, new onset of migraine. Contains lactose. C Inducers of P450 enzymes (anticonvulsants, anti-infectives), ritonavir and nelfinavir, St Johnâ&#x20AC;&#x2122;s wort. A Breakthrough bleeding or breast changes, nausea, bloating, headache, leg cramps, weight change, asthenia.
MENOPAUSAL DISORDERS,
OBSTETRICS
297
17.5 MENOPAUSAL
DISORDERS, OSTEOPOROSIS
A22.93.
OBSTETRICS AND
5O
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.
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. Q Not indicated. 2MO D Known, suspected or past history of Bisphosphonate. Alendronic acid 70mg. Round, breast cancer or oestrogen-dependent neoplasia, white, biconvex tab. marked 70. 4, A19.50. or any condition where oestrogen use is S Postmenopausal osteoporosis. Reduces contraindicated. Pregnancy, lactation. risk of vertebral and hip fractures. B Not recommended: Naturally P 70mg once weekly, at least 30 min before 1st food, beverage, or medicinal product of menopausal women, women on concomitant conjugated equine oestrogens. Monitor for the day with plain water only (r 200ml). Do not potential androgenic undesirable effects; signs of lie down until after 1st food of the day (at least virilisation may be irreversible, consider 30 min after taking tab). discontinuation. Discontinue if local Q Children and adolescents, not hypersensitivity occurs. Little information available recommended. on long-term safety. Monitor for breast cancer. D For other prescribing information, see Caution: Cardiovascular risk factors, cardiovascular alendronate Drug Presc. Notes. disease; monitor carefully (particularly changes in IDEOS Helsinn Birex BP and weight). May decrease thyroxin-binding globulin levels. Pre-existing cardiac, renal, or 2Y hepatic disease: Oedema may occur (at doses Calcium/vit. D suppl. Ca++ carbonate 1.25g (equiv. higher than delivered by the patch). Ca++ 500mg), vit. D3 400 IU. Lemon flavoured C Anticoagulants. white square chewable tab. 60, A8.61. A Insomnia, migraine, voice deepening, S Calcium/vit. D deficiency in elderly, acne, alopecia, hirsutism, breast pain, increased adjunct in osteoporosis. weight. P 1 twice a day. Q Not recommended. KLIOGEST Novo Nordisk D Hypercalcaemia, hypercalciuria, Ca++ 2NO lithiasis, tissue calcification. Prolonged Oestrogen/progestogen (continuous combined). immobilisation. Vit. D overdose, myeloma and Oestradiol 2mg, norethisterone acetate 1mg. bone metastases, renal insufficiency. White tab. 28, A5.75. B Mild to moderate renal failure. C Tetracyclines, vit. D, etidronate, cardiac S Treatment of climacteric symptoms and prevention of osteoporosis in post menopausal glycosides, fluoride, thiazide diuretics. women. A Hypercalciuria, hypophosphataemia, P One taken daily without interruption at nausea, mild GI disturbance. the same time each day. INDIVINA Orion Q Not applicable. D Porphyria. See SPC. 2NO Oestrogen/progestogen (continuous combined). LIVIAL Schering-Plough Oestradiol valerate 1mg, medroxyprogesterone acetate 2.5mg white tab. marked 1+2.5; oestradiol 5 N O valerate 1mg; medroxyprogesterone acetate 5mg Gonadomimetic. Tibolone 2.5mg. White round white tab. marked 1+5; oestradiol valerate 2mg, tab. marked ORGANON one side, MK/2 on reverse. medroxyprogesterone acetate 5mg white tab. 28, A15.14. A marked 2+5. 1mg/2.5mg-1 x 28, 8.80; 1mg/5mg-3 S Oestrogen deficiency symptoms in x 28, A26.39; 2mg/5mg-3 x 28, A26.39. postmenopausal women, q1 year after S Replacement therapy for oestrogen menopause. 2nd line therapy for prevention of deficiency symptoms and prophylaxis of osteoporosis in postmenopausal women at high osteoporosis in women more than three years risk of future fractures. after menopause with an intact uterus. P 1 daily swallowed with water preferably P 1 tab. daily without a break between at same time each day. packs. Initiate therapy with 1mg/2.5mg tab. D Pregnancy, lactation. OestrogenDepending on clinical response to treatment the dependent tumours, current or past breast cancer, dosage can then be adjusted according to undiagnosed vaginal bleeding, endometrial individual needs. Change to 1mg/5mg if hyperplasia, previous idiopathic or current venous breakthrough bleeding occurs; change to 2mg/ thromboembolism, history of arterial 5mg if oestrogen deficiency symptoms not thromboembolic disease (eg. angina, MI, stroke or adequately controlled. For maintenance therapy, TIA), liver disease, porphyria. lowest effective doses should be used. B Carefully assess risks of stroke, breast Q Not applicable and endometrial cancers. Caution: Leiomyoma, D See SPC. endometriosis, hypertension, 1st degree heredity for breast cancer, risk factors for thromboembolic INTRINSA P & GP disorders, hypertension, liver disorders, diabetes,
298
GYNAECOLOGY
cholelithiasis, migraine, SLE, history of endometrial hyperplasia, epilepsy, asthma, otosclerosis. Discontinue if jaundice, new migraine onset, significant BP increase, elective surgery followed by prolonged confinement. C Caution: Anticoagulants, midazolam, other CYP3A4 substrates, certain antibiotics, antiepileptic drugs or sedatives. A Abnormal hair growth, endometrial wall thickening, postmenopausal/vaginal haemorrhage, breast tenderness, genital pruritus/discharge, vaginal candidiasis, pelvic/ lower abdominal pain, cervical dysplasia, vulvovaginitis.
MIRENA
Bayer Schering
2NO IUS. Levonorgestrel 52mg. T-shaped intrauterine system. 1, A107.88. S Protection from endometrial hyperplasia during estrogen replacement therapy. P To be inserted into the uterine cavity at any time in amenorrheic women, or during last 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. A Weight gain, oedema, headache, lower abdominal pain, back pain, acne, vaginal discharge, cervicitis, dysmenorrhea, mastalgia, breast tension, depression, mood changes, nausea, expulsion.
NOVOFEM
Novo Nordisk
2NO Oestrogen/progestogen (sequential combined). Estradiol hemihydrate 1mg (16 red film-ctd tabs). Estradiol hemihydrate 1mg, norethisterone acetate 1mg (12 white film-ctd tabs). 3 x 28, A19.30. S HRT for oestrogen deficiency in post menopausal women with an intact uterus. Prevention of postmenopausal osteoporosis in women with an incresed risk for future osteoporotic fractures. P 1 daily without a break between packs, taken in the following order: (red tabs.) over 16 days, followed by 12 days (white tabs). Q Not applicable D Breast cancer, oestrogen-dependent tumours, undiagnosed genital bleeding, active or recent thromboembolic events, liver disease. Pregnancy. B Take personal and family history before initiation of HRT, leiomyoma, endometriosis, hypertension, diabetes mellitus with vascular involement, sudden hearing loss, migraine or severe headache. History of thromboembolism, hyperplasia of the endometrium, fibrocystic disease of the breast, history of liver disease. See SPC.. C See SPC A Breast tenderness, vaginal candidiasis, dizziness, insomnia, depression, increased BP, dyspepsia, abdominal pain, nausea, rash, pruritus,
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,
vaginal haemorrhage, uterine fibroids aggrevated, oedema, weight increase.
Oestrogen/progestogen (sequential combined). Conjugated oestrogens 0.625mg (28 maroon oval tabs.) or 1.25mg (28 yellow oval tabs.) norgestrel OSTEOFOS D3 A. Menarini 0.15mg (12 brown tabs.). All sug-ctd tabs. 0.625mg-40, A4.73. 1.25mg-40, A4.73. 2MO S Menopausal and post-menopausal Calcium/vit. D suppl. Ca++ phos. 3100mg (equiv. Ca++ 1200mg), cholecalciferol 20mcg (equiv. vit. D3 hormone replacement in women with an intact uterus, post menopausal osteoporosis, atrophic 800 IU). Sachet, containing powder for oral susp. vaginitis or urethritis. 30 sachets, A9.53. D See SPC. S Correction of combined vit. D and calcium deficiency in elderly. As an adjunct to PREOTACT Nycomed specific treatment for osteoporosis. 2NT R 1 sachet daily. Q Not recommended. Parathyroid hormone. Parathyroid hormone D Hypercalcaemia, hypercalciuria, severe 100mcg per dose. Powder and solvent for soln for renal insufficiency. Pregnancy, lactation. inj. in cartridge (14 doses). 2, A415.29. B CVD. Sarcoidosis. S Osteoporosis in postmenopausal women C Tetracycline, penicillin, neomycin, at high risk of fractures (evidence for vertebral, chloramphenical, fluoride, bisphosphonates, not hip fractures). thiazide diuretics, frusemide, ethacrynic acid, P 100mcg daily as SC injection into the cardiac glycosides. abdomen. Duration, up to 24 months. Following A Mild GI disturbances, hypercalcaemia. treatment patients can be treated with a bisphosphonate to further increase bone mineral OSTEOMEL Clonmel density. Q Under 18 years, not recommended. 2MO D Previous radiation therapy to the Bisphosphonate. Alendronic acid 70mg (as skeleton, pre-existing hypercalcemia and other alendronate Na+ trihydrate). Oval, white tab., disturbances in phosphocalcic metabolism, marked AN70 and logo on reverse. 4, A22.17. metabolic bone diseases other than primary S Postmenopausal osteoporosis. osteoporosis, unexplained elevations of boneP 1 once weekly taken with plenty of water (not mineral water) at least 30 mins. before specific alkaline phosphatase. Severe renal/severe hepatic impairment. 1st food/beverage or medicinal product of the B Monitor at months 1, 3 and 6 for day. Do not lie down until after 1st food which elevated serum/urinary Ca++. Persistent above UNL, should be min. 30 mins. after taking tab. reduce frequency or discontinue. Supp. Ca++ and Q Children and adolescents, not vit D if dietary intake inadequate. Active or recommended. previous urolithiasis (caution). Contains metacresol. B Contains lactose. For other prescribing Driving / using machines. information, see alendronate Drug Presc. Notes. C Caution: Cardiac glucosides. PREMARIN Wyeth Alendronate (no additional benefit). A Hypercalcemia, hypercalciuria, nausea, 2NO GI disorders, headache, dizziness, palpitations, Oestrogen. Conjugated oestrogens 0.625mg muscle cramp, pain, fatigue, inj. site reactions. maroon oval sug-ctd tab. 1.25mg yellow oval sugctd tab. Both either unmarked or marked PROTELOS Servier PREMARIN. 0.625mg-28, A2.49; 1.25mg-28, A3.36. 2MO S Menopausal and post-menopausal oestrogen replacement in hysterectomised women; Dual Action Bone Agent (DABA). Strontium ranelate 2g. Granules for oral suspension. Sachetspost-menopausal osteoporosis, atrophic vaginitis 28, A39.21. or urethritis. Palliation of selected cases of breast S Postmenopausal osteoporosis to reduce cancer. risk of vertebral and hip fractures. P Menopause, usually 0.625-1.25mg daily where continuous admin. is recommended. In non- P 2g once daily taken in water at bedtime, preferably at least 2 hours after eating. hysterectomised women the addition of a Q Children and adolescents, not progestogen 12-14days per cycle is essential. recommended. Q Not applicable. D Pregnancy, lactation. D See SPC. B Severe renal impairment, not PREMIQUE 5 Wyeth recommended. Chronic renal impairment, monitor renal function. Increased risk of venous 2NO thromboembolism (caution). Drug rash with Oestrogen/progestogen (continuous combined). eosinophilia and systemic symptoms (DRESS) Conjugated oestrogens 0.625mg, medroxyprogesterone acetate 5mg. Blue oval sug- (withdraw if occur). Interferes with colorimetric methods of Ca++ determination. Contains ctd tab. 28, A9.64. aspartame. S Period-free HRT for menopausal C Products containing Ca++ (take 2 hours symptoms and prevention of osteoporosis in post apart). Oral tetracycline or quinolone antibiotics menopausal women with an intact uterus. (not recommended). Antacids (take q2 hours after P 1 daily without break starting on 1st Protelos). day of cycle or at anytime if not menstruating A Headache, GI disorders, dermatitis, regularly. eczema, transient increases in creatine kinase Q Not applicable. activity. D See SPC.
PREMPAK-C 2NO
Wyeth
ROCALTROL 2MO
Roche
OSTEOPOROSIS
17.5
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 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.
SANDOCAL 400
Novartis Consumer
2 Calcium suppl. Ca++ lactate gluconate 931mg, calcium carbonate 700mg providing calcium 400mg (10 mmol), citric acid. White efferv. tab. 5 x 20, A10.30. S Osteoporosis. P 3-5 daily. Q Not applicable. D Severe hypercalcaemia, hypercalciuria (e.g. hyperparathyroidism, vit. D overdose, decalcifying tumours such as plasmocytoma and skeletal metastases, immobilisation osteoporosis, sarcoidosis), severe renal failure, milk-alkali syndrome, galactosaemia. B Renal impairment, electrolyte imbalance. Monitor for nephrocalcinosis. Avoid vit. D. C Digoxin, cardiac glycosides, tetracyclines. A Mild GI disturbances (constipation, diarrhoea). Symptoms indicating hypercalcaemia (nausea, vomiting, anorexia, constipation, abdominal pain, bone pain, thirst, polyuria, muscle weakness, drowsiness, confusion).
TEVANATE
Teva
2MO Bisphosphonate. Alendronic acid 70mg (as alendronate Na+ monohydrate). White, flat-faced bevel-edged round tablet, debossed with T on one side. 4, A20.30. 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.
TRISEQUENS
Novo Nordisk
2NO
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
299
17.6 OBSTETRICS
OBSTETRICS AND
Oestrogen/progestrogen. Estradiol 2mg (12 blue tabs.); estradiol 2mg, norethisterone acetate 1mg (10 white tabs.); estradiol 1mg (6 red tabs.). All film-ctd, biconvex tabs. marked with NOVO 280, 281 and 282 resp. 28, A4.59. S Oestrogen deficiency. Prevention of osteoporosis in postmenopausal women at high risk of future fractures where other drugs are inappropriate. P 1 daily without interruption. Q Not applicable. D Known, past or suspected breast cancer, oestrogen-dependent malignant tumours, undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism, active or recent arterial thromboembolic disease (e.g. angina, MI), acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal, porphyria. Pregnancy, lactation. B Periodic check-ups are recommended. Monitor changes in breasts. Caution: Leiomyoma 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, significant increase in BP, new onset of migraine, pregnancy. C Inducers of P450 enzymes such as anticonvulsants and anti-infectives, ritonavir and nelfinavir, St Johnâ&#x20AC;&#x2122;s wort, ketoconazole. A Genital candidiasis or vaginitis, fluid retention, depression, headache, migraine, abdominal pain or discomfort, nausea, back pain, leg cramps, breast pain, breast oedema or enlargement, menstruation disorders, uterine fibroids, oedema peripheral, weight gain.
D Porphyria, past or active breast cancer, oestrogen-dependent malignant tumours (e.g. endometrial cancer), undiagnosed genital bleeding, untreated endometrial hyperplasia, previous idiopathic or current venous thromboembolism. Pregnancy, lactation. B Periodic check-ups (incl. pelvic and breast) recommended. See SPC. C Caution: CYP 450 enzymes inducers. A Genital candidiasis or vaginitis, vaginal discharge or bleeding, breast disorders, headache, GI disorders, oedema.
GYNAECOLOGY
2 ALSO PROSTIN E2 VAGINAL TABS. Dinoprostone 3mg white vag. tab. marked UPJOHN and 715. 8, A87.66.
2 ALSO PROSTIN E2 SOLUTIONS Dinoprostone 1mg/ ml. Clear, colourless alcoholic soln. in amps. 1mg/ ml (IV), A10.02. 10mg/ml, A21.64.
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 17.6 OBSTETRICS fetal and maternal contraindications. BRICANYL INJECTION AstraZeneca P See SPC. D Previous Caesarean sections or major 5NO uterine surgery, major degrees of cephalopelvic Selective b2 -agonist. Terbutaline sulph. 0.5mg/ml. disproportion, fetal malpresentation, pre-existing Amp. 5 x 1ml, A1.61. fetal distress, history of difficult or traumatic S Uncomplicated premature labour. delivery, multiparae with over five previous term P 10-25mcg per minute by IV inf.; see SPC. pregnancies, past history of, or existing, pelvic Q Not applicable. inflammatory disease. D Antepartum haemorrhage; toxaemia of B Monitor uterine activity, fetal status and pregnancy; cord compression; threatened progression of cervical dilation regularly. History abortion; conditions where prolongation of of uterine hypertonic contractility or tetanic pregnancy is hazardous. uterine contractions. Patients in whom oxytocic B Maternal thyrotoxicosis or CVD, drugs are contraindicated or prolonged uterine diabetes. Monitor maternal and foetal heart rate. contractions are undesirable. Glaucoma, increased C b-blockers, other b-agonists. IOP, asthma (or history of), questionably adequate A Tachycardia, anxiety, rise in blood sugar. cephalopelvic proportions. C Oxytocin. PABAL Ferring A Nausea, vomiting, diarrhoea, flushing, 2J shivering, headaches. Oxytocin agonist. Carbetocin 100mcg/ml. Clear SYNTOCINON Novartis colourless sln for inj. in amp. 1ml-5, A135.33. S Prevention of uterine atony following 2N 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 UTROGESTAN Besins D During pregnancy and labour before postpartum uterine atony and haemorrhage. As 2N delivery of the infant (do not use to induce an adjunct for the management of incomplete or Progestogen. Micronised progesterone 100mg. labour). Hepatic or renal disease. Pre-eclampsia, missed abortions. White soft gelatin cap. 30, A6.05. eclampsia. Serious cardiovascular disorders. P Induction of labour: IV inf. rate 1S Hormonal replacement therapy for the Epilepsy. 4milliunits/min increased if necessary at intervals menopause. B Not appropriate for use at any stage r20 min. Pregnancy near term: Inf. Q P Usually 300mg daily as a single or in before delivery. If uterine bleeding persists, 10milliunits/min; max. rate 20milliunits/min. divided doses for 10-14 consecutive days with determine causes (e.g. retained placental Caesarean section: 5 IU by slow IV inj. immediately concurrent admin. of oestrogen during the last 10- fragments, inadequate emptying or repair of the after delivery. Prevention of postpartum uterine 14 days of cycle. uterus, or disorders of blood coagulation). haemorrhage: 5 IU slowly IV after delivery of Q Not applicable. Intended for single admin. only; if uterine placenta. Treatment of postpartum uterine D History of thromboembolic disorders. hypotonia/atonia with consequent excessive haemorrhage: 5 IU slowly IV, severe cases followed Pregnancy. Mammary or genital carcinoma. Liver bleeding persists, consider additional therapy with by IV inf. containing 5-20 IU oxytocin in 500ml dysfunction. Vascular disease. Undiagnosed oxytocin and/or ergometrine. Hyponatraemia may electrolyte containing diluent. Incomplete or abnormal vaginal bleeding. occur. Caution: Migraine, asthma, cardiovascular missed abortion: 5 IU slowly IV followed by IV inf. B Antibiotics, anti-epileptic drugs, disease or any state in which a rapid addition to rate 20-40milliunits/min or higher. sedatives. extracellular water may produce hazard for an D Hypertonic uterine contractions, C Antibiotics, anti-epileptic drugs, already overburdened system. mechanical obstruction to delivery, foetal distress. sedatives. C Not recommended: Prostaglandins. Any condition where spontaneous labour is Caution: Vasoconstrictor in conjunction with inadvisable or vaginal delivery contraindicated. VAGIFEM Novo Nordisk caudal-block anaesthesia. Inhalation anesthetics (e.g. halothane cyclopropane), ergot-alkaloids (e.g. 2NO PRESCRIBING NOTES methylergometrine, oxytocin). OBSTETRICS Oestrogen. Oestradiol 0.025mg. White film-ctd A Headache, tremor, hypotension, BETA AGONISTS. Terbutaline causes vaginal tab. marked NOVO 279. 3 x 5 applicators, relaxation of uterine muscles and is used to flushing, GI disorders, pruritus, feeling of warmth. A13.41. inhibit premature labour. Anaemia, dizziness, chest pain, dyspnoea, metallic S Atrophic vaginitis due to oestrogen Oxytocin, ergometrine and prostaglandin, taste, vomiting, back pain, chills, pain. deficiency. all induce uterine contraction and are used to P Initially 1 daily for two weeks. induce abortion, induce or augment labour and PROSTIN E2 Pfizer Maintenance, 1 twice weekly. Treatment should minimise blood loss from the placental site 2J be limited to as short a time as possible. following delivery. Prostaglandin. Dinoprostone 0.5mg white R Over 65 years, limited experience. References available on request. rectangular tab. marked U 76. 10, A20.13. Q Not applicable.
300
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
B Do not use for long periods in patients with oxytocin resistant uterine inertia, severe preeclamptic toxaemia or severe CVD. Excessive doses may cause foetal distress, asphyxia, or death. Monitor foetal HR and uterine motility carefully. Caution: Borderline cephalopelvic disproportion, 2o uterine inertia, pregnancy-induced hypertension or CVD, patients q 35 yrs or a history of lower uterine segment caesarean section. Avoid rapid IV bolus inj. Driving/operating machinery. C Prostaglandins, inhalation anaesthetics, sympathomimetic vasoconstrictors. A Headache, GI disturbances, tachycardia, bradycardia.
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 SYNTOMETRINE Novartis after start of agonist treatment in protocols 2NO involving downregulation with GnRH agonists, or Uterotropic. Ergometrine maleate 0.5mg, synthetic in protocols not involving downregulation, start oxytocin 5 units per ml; 1ml amp. 5, A1.11. on day 2-3 of cycle. 150-225 IU daily for at least 1st S Prevention and control of post-partum 5 days, increase by R 150 IU increments. Max. haemorrhage. Active management of 3rd stage of daily R 450 IU. Duration: Up to 12 days. At labour. optimal response admin. 10,000 IU hCG by a single P 1ml by IM inj. inj. 1 day following the last inj. Q Not applicable. D Tumours of the pituitary or D Severe kidney, liver or cardiac hypothalamic glands. Ovarian, uterine or dysfunction, severe hypertension, pregnancy, mammary carcinoma. Pregnancy, lactation. obliterative vascular disease, sepsis. Gynaecological haemorrhage of unknown B Malnutrition, Raynaud’s disease. Mild to aetiology. Primary ovarian failure. Ovarian cysts or moderate hypertension, cardiac, liver or kidney enlarged ovaries not due to polycystic ovarian disease. disease. Malformation of sexual organs or fibroid C Sympathomimetic amines, tumours of the uterus incompatible with vasoconstrictors, prostaglandins, halothane. pregnancy. A Nausea, vomiting, abdominal pain, B Monitor ovarian response with headache, dizziness, rash, hypertension, ultrasound and serum oestradiol levels, regularly. bradycardia, cardiac arrythmias, chest pain, Hypothyroidism, adrenocortical deficiency, anaphylactoid reactions. hyperprolactinemia and pituitary or hypothalamic TRACTOCILE Ferring tumours. Risk of ovarian enlargement, Ovarian Hyperstimulation Syndrome (OHSS), multiple 2N pregnancy. Personal or family history of Oxytocin antagonist. Atosiban (as acetate) 7.5mg/ thromboembolic events, severe obesity. ml; soln. in vial. Injection_0.9ml, A36.44; C Clomiphene citrate may enhance Infusion_5ml, A104.72. follicular response. GnRH agonist (may increase S To delay imminent pre-term birth in dosage needed). women with regular uterine contractions of at A UTI, nasopharyngitis, headache, hot least 30 seconds duration at a rate equal or greater than 4/30 mins. with cervical dilation of 1- flushes, GI disorders, rash, muscle spasms, vaginal haemorrhage, OHSS, pelvic pain, breast 3 cm (0-3 cm for nulliparous) and effacement of tenderness, vaginal discharge, pain, inj. site pain 50% or more, a gestational age from 24 until 33 and reactions. complete weeks, and a normal foetal heart rate. P Initially, a bolus dose of 6.75mg by i.v. CETROTIDE Merck Serono inj. over 1 min. started as soon as possible after diagnosis of pre-term labour, immediately 2N followed by a continuous high dose loading i.v. LH-RH antagonist. Cetrorelix (as acetate) 0.25mg, inf. of 300 microgram/min. over 3 hours, followed 3mg. Powder in vials plus solvent in pre-filled by a lower dose subsequent i.v. inf. of 100 syringe. 0.25mg-1, A36.16; 7, A253.19; 3mg-1, microgram/min. for up to 45 hours. Max. duration A253.19. of treatment 48 hours; max. total dose, 330mg. S Prevention of premature ovulation in Discontinue if uterine contractions persist. controlled ovarian stimulation, followed by oocyte Q Under 18 years, not recommended. pick-up and assisted reproductive techniques. D Gestation Q24 or q33 complete weeks. P 0.25mg once daily by SC inj. into lower Premature rupture of the membranes over 30 abdominal wall given within 96-120 hours of weeks. Any conditions of the mother or foetus, in starting ovarian stimulation with gonadotrophins. which continuation of pregnancy is hazardous. Continue up to and incl. day of ovulation B Suspected premature rupture of induction. Alternatively, a single 3mg SC inj. on membrane, abnormal placental site. Retreatment day 7 of ovarian stimulation. If ovulation is not experience limited to three treatments. Monitor possible on 5th day after inj., additionally 0.25mg uterine contractions and foetal heart rate during inj. once daily until day of ovulation induction. treatment and for blood loss after delivery. Q Not applicable. A Nausea, headache, dizziness, vomiting, D Moderate to severe renal or hepatic hot flushes, tachycardia, hypotension, impairment. Postmenopause. Pregnancy, lactation. hyperglycaemia, inj. site reactions. B Repeated cycles. Active allergic 17.7 INFERTILITY conditions. A Inj. site reactions, nausea, headache, BRAVELLE Ferring hypersensitivity reactions.
CLOMID
sanofi-aventis
5NO Antioestrogen. Clomiphene citrate 50mg. Beige scored tab. marked M within two circles. 30, A13.40. S Ovulatory failure in women desiring pregnancy. P 1 tab. daily for 5 consecutive days, starting on fifth day of menstruation if possible. Do not use for longer than 3 cycles in absence of an ovulatory response. See SPC. Q Not applicable. D Pregnancy. Liver dysfunction. Ovarian dysgenesis. Menopause. Ovarian cyst. Abnormal uterine bleeding. B Ovarian Hyperstimulation Syndrome, visual symptoms, multiple pregnancy, ectopic pregnancy, uterine fibroids, birth anomalies, ovarian cancer. Contains lactose and sucrose. A Ovarian enlargement, vasomotor flushes, abdominal/pelvic discomfort, convulsions (patients with history of seizures may be predisposed), nausea and vomiting, breast discomfort, headaches, intermenstrual spotting or menorrhagia, endometriosis, dermatitis and rash.
CRINONE
Merck Serono
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.
DECAPEPTYL SR
Ipsen
6NT Gn-RH analogue. Triptorelin 3mg. 5ml vial containing powder plus 2ml diluent. 1, A157.61. S Female infertility. P 1 vial (3mg) as single IM inj. Start on day 2 of cycle. Stimulation by gonadotrophins should be performed when the blood oestrogen level is less than 50 pg/ml, which is usually around day 15 of cycle. See SPC. Q Not applicable. D Pregnancy. B See SPC. A Hot flushes, headache, asthenia. Combined treatment with gonadotrophins may induce an ovarian hyperstimulation. See SPC.
DOSTINEX
Pharmacia
2NO Dopamine agonist. Cabergoline 0.5mg. White capsule shaped flat scored tabs. marked P and U on one face and 700 on the other. 8, A34.01. S Hyperprolactinaemic disorders incl. amenorrhoea, oligomenorrhoea, anovulation and galactorrhoea. Prolactin secreting pituitary adenomas, empty sella syndrome with associated
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
301
17.7 INFERTILITY
OBSTETRICS AND
GYNAECOLOGY
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 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 LUVERIS Merck Serono carcinoma. B Before treatment evaluate for 6N hypothyroidism, adrenocortical deficiency, Gonadotrophin. Lutropin alfa (recombinant human LH) 75 IU. Powder and solvent for soln for hyperprolactinaemia, pituitary or hypothalamic tumours and treat accordingly. Monitor ovarian inj. in vial. 75 IU, A57.15. activity and oestrogen response to avoid S In association with a FSH preparation hyperstimulation. In males, elevated for the stimulation of follicular development in gonadotrophin levels indicate primary testicular women with severe LH and FSH deficiency. failure; do not usually respond to this therapy. P 75 IU daily by SC inj. with 75-150 IU Ovarian enlargement, hyperstimulation, Ovarian FSH. May be increased at 7-14 day intervals and Hyperstimulation Syndrome (OHSS) may occur. Risk preferably by 37.5 IU-75 IU increments. hCG factors for thromboembolic events. Contains should be admin. 24-48 hours after last inj. lactose. D Ovarian, uterine, or mammary C Clomiphene citrate, GnRH agonist carcinoma, untreated tumours of hypothalamus (adjust dose). and pituitary gland, ovarian enlargement or cyst A Nausea, abdominal/pelvic pain, enlarged not due to polycystic ovarian disease (PCOD), DUPHASTON Solvay gynaecological haemorrhages of unknown origin. abdomen, inj. site reaction/pain, headache, OHSS. 2NO Conditions incompatible with pregnancy. ORGALUTRAN Schering-Plough Progestogen. Dydrogesterone 10mg. White scored B Hypothyroidism, adrenocortical 2NO deficiency, hyperprolactinemia and pituitary or tab. marked S and 155. 42, A8.16. hypothalamic tumours. Increased risk of GnRH antagonist. Ganirelix 0.25ml/0.5ml. Sln for S Infertility due to inadequate luteal hyperstimulation, ovarian hyperstimulation inj. 0.5ml syringe, A30.19. phase. syndrome (OHSS), multiple pregnancies. Monitor S Prevention of premature LH surges in P See SPC. ovarian response prior to and during therapy controlled ovarian hyperstimulation for assisted D See section 17.1. especially in patients with PCOD; ultrasound scans reproduction techniques (ART). GONAL-F Merck Serono and oestradiol measurements are recommended. P SC inj. once daily preferably in the C Do not mix with other drugs, except upper leg, starting on day 6 of FSH admin. See 2N follitropin alfa. SPC. Gonadotrophin. Follitropin alfa 75 IU (5.5mcg)/ml, A Inj. site reaction, headache, somnolence, D Hypersensitivity to GnRH or analogues. 300 IU (22mcg)/0.5ml; 450 IU (33mcg)/0.75ml, 900 nausea, abdominal pain, pelvic pain, OHSS, Moderate or severe renal or hepatic impairment. IU (66mcg)/1.5ml, 1050 IU (77mcg)/1.75ml. Single/ ovarian cyst, breast pain. Pregnancy, lactation. multidose vials or pre-filled pen. Single dose: 75 B Ovarian hyperstimulation syndrome may IU-1, A38.20; 5, A192.67. Multidose: 450 IU-1, MENOPUR Ferring occur. Severe allergic conditions (avoid), women A231.20; 1050 IU-1, A539.48. Pre-filled pen: 300 Q50kg or q90kg (no data). 6N IU-1, A162.55; 450 IU-1, A243.83; 900 IU-1, A Local skin reaction. A487.66. Gonadotropin Menotrophin (human menopausal gonadotrophin HMG), human follicle stimulating S Anovulation (incl. PCOD) in women Merck Serono hormone (FSH) 75 IU, human luteinising hormone OVITRELLE unresponsive to treatment with clomiphene. 6N (LH) 75 IU 10, A232.50. Multifollicular stimulation in superovulation for Gonadotropin. Choriogonadotropin alfa 250mcg/ S Anovulation, including polycystic IVF, GIFT and ZIFT. Severe LH and FSH deficiency 0.5ml (equiv. 6500 IU). Soln. in pre-filled syringe. ovarian disease (PCOD), if no response to (serum LH levelQ1.2 IU/l) in association with LH 1, A43.88. clomiphene citrate; controlled ovarian preparation. S Superovulation in assisted reproductive P Anovulation: Start within first 7 days of hyperstimulation for assisted reproductive techniques such as IVF. Anovulatory infertility. cycle. 75-150 IU FSH daily SC, increased preferably technologies (ART). Hypogonadotrophic P Superovulation, 250mcg by SC inj. 24-48 hypogonadism in men. by 37.5 IU, or 75 IU at 7 or preferably 14 day intervals if necessary. Max. daily dose: 225 IU FSH. P Anovulatory infertility: Start within first hours after last admin. of FSH or hMG. Superovulation: 150-225 IU, starting on days 2 or 3 7 days of menstrual cycle. Initially, 75-150 IU daily Anovulation, 250mcg by SC inj. 24-48 hours after of cycle. Max.: 450 IU daily. Duration 5-20 days. LH for at least 7 days. Adjust with increments of 37.5 optimal stimulation of follicular growth. Q Not applicable. IU (max. 75 IU) with at least 7 day intervals. Max. and FSH deficiency: 75 IU of lutropin alfa daily D Tumours of hypothalamus and pituitary with 75-150 IU FSH, increased by 37.5 IU- 75 IU at daily dose, 225 IU. Abandon treatment course if gland, ovarian enlargement, or cyst due to reasons 7-14 day intervals if necessary. All three indications: no response in 4 weeks, and restart at higher starting dose. Optimal response, admin. hCG 5000- other than polycystic ovarian disease, At optimal response, admin. 5000 IU- 10000 IU gynaecological haemorrhages of unknown 10000 IU 1 day after last Menopur inj. hCG by single inj. 24-48 hours after. aetiology, ovarian, uterine or mammary Superovulation: Start approx. 2 weeks after start D Pituitary or hypothalamus tumours. carcinoma. Extra uterine pregnancy in the previous of GnRH agonist or on day 2 or 3 of menstrual Ovarian cyst or enlargement not associated with 3 months, active thrombo-embolic disorders, PCOD. Gynaecological haemorrhages of unknown cycle if GnRH agonist not involved. Initially, 150primary ovarian failure. Malformations of sexual 225 IU daily for at least 5 days. Adjust with aetiology, ovarian, uterine or mammary organs incompatible with pregnancy. Fibroid carcinoma. Primary ovarian failure, malformations increments of max. 150 IU. Max. daily dose, 450 tumours of the uterus incompatible with IU; max. recommended duration 20 days. Follow of sexual organs or fibroid tumours of uterus pregnancy, postmenopausal women. Pregnancy, by single inj. of up to 10,000 IU hCG. Male incompatible with pregnancy. Pregnancy, lactation. infertility: Spermatogenesis stimulated with CG lactation. 1000-2000 IU 2-3 times a week and then Menopur B Before treatment patients should be B Hypothyroidism, adrenocortical evaluated for hypothyroidism, adrenocortical dose of 75 or 150 units of FSH with 75 or 150 deficiency, hyperprolactinemia. Monitor ovarian units of LH 2-3 times weekly. Continue for at least deficiency, hyperprolactinemia, pituitary or response with ultrasound and oestradiol idiopathic hyperprolactinaemia and idiopathic hyperprolactinoma. P Initially 1 tab. per week in one or two doses. If necessary, increase gradually by 1 tab. per week at monthly intervals. Usual maintenance dose 2 tabs. per week in single or divided doses; max. 9 tabs. per week. Tabs. should be taken with food. Q Not recommended. D Hypersensitivity to ergot alkaloids. Hepatic insufficiency, toxaemia of pregnancy. Lactation. Do not co-administer with antipsychotics. B Evaluate pituitary prior to treatment. Renal, hepatic or cardiac disease, Raynaudâ&#x20AC;&#x2122;s syndrome, GI ulceration or bleeding. Psychotic disorders. Monitor gynaecological changes. Discontinue at least 1 month before trying to conceive. Use mechanical contraception if conception is not desired. See SPC. C Long-term ergot alkaloids, dopamine agonists, dopamine antagonists, macrolide antibiotics, anti-psychotics. A Nausea, headache, dizziness, abdominal pain, fatigue, constipation, vomiting, breast pain, hot flushes, depression, paresthesia.
302
measurements. Risk of ovarian enlargement, Ovarian Hyperstimulation Syndrome (OHSS), multiple pregnancy. Personal or family history of thrombo-embolic events. C Clomiphene citrate, hCG (may potentiate follicular response). GnRH agonist or antagonist (may increase dosage needed). A Ovarian cysts, inj. site reaction, headache, mild to moderate OHSS, abdominal pain and GI 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
TOXICOLOGY hypothalamic tumours. Increase risk of developing ovarian hyperstimulation syndrome (OHSS). Monitor oestradiol levels prior and during therapy. Risk of multiple pregnancy. A Local reactions/pain at inj. site. Headache, nausea, vomiting, abdominal pain, mild to moderate ovarian hyperstimulation syndrome.
TOXICOLOGY 18.1 pituitary, hypothalamus, ovary, breast or uterus. Fibroid tumours of uterus or malformation of
pain and GI symptoms.
PREGNYL
Schering-Plough sexual organs incompatible with pregnancy.
6NO
Gonadotrophin. Human chorionic gonadotrophin 5000 IU. Powder and solvent for soln. for inj. 1, A3.91. S Anovulatory sterility and secondary PARLODEL Meda amenorrhoea (induce ovulation in ovary previously 2MO primed with FSH, and facilitate subsequent corpus luteum production). Controlled hyperstimulation Dopamine agonist. Bromocriptine (as mesylate) 2.5mg. White tab. scored and marked XC one side regimens (prepare the follicles for harvesting). A A P Anovulatory Sterility and controlled Sandoz on reverse. 30, 6.44; 100, 21.47. hyperstimulation regimens: One IM or SC inj. 50002MO 10000 IU for 1 or 3 days in sequence to HMG. Up ALSO PARLODEL CAPSULES Bromocriptine (as to 3 repeat inj. 5000 IU each may be given within mesylate) 5mg. Blue/white cap. marked P5. 100, the following 7 days to prevent insufficiency of A41.84. corpus luteum. S Endocrine-based infertility. Q Not applicable. P Initially, 1.25mg at bedtime. Titrate gradually at 2 to 3 day intervals to 7.5mg daily in B Asthma, migraine, epilepsy, cardiac/renal dysfunction. Allergic diathesis. divided doses with meals; max 30mg daily. A Growth spurt (particularly if epiphyseal Q Not applicable. growth potentially active). Fluid retention. Ovarian D Hypersensitivity to ergot alkaloids. enlargement or cysts, acute abdominal pain, super B Usage requires regular surveillance. ovulation, multiple pregnancies. History of peptic ulceration, psychotic or severe cardiovascular disorders. If pregnancy is undesired, Pharmacia use contraception, Perform regular gynaecological PROVERA assessment for women receiving prolonged 2NO therapy. Observe patients on long term high doses Progestogen. Medroxyprogesterone acetate 2.5mg, for manifestations of retroperitoneal fibrosis. 5mg, 10mg. Orange scored tab. marked U64, blue C Alcohol, erythromycin, psychoactive scored tab. marked 286 and white scored tab. agents, drugs effecting BP. marked UPJOHN 50. 2.5mg-30, A2.18; 5mg-30, A Postural hypotension, nausea, vomiting, A4.43; 5mg-100, A14.75; 10mg-90, A27.51. mild constipation, dry mouth, leg cramps, rarely S Dysfunctional (anovulatory) uterine hypertension, MI, strokes, drowsiness, confusion, bleeding.Mild to moderate hallucinations, headache, dizziness, seizures, endometriosis.Secondary amenorrhoea. episodes of reversible pallor of fingers and toes P Endometriosis: 10mg three times daily induced by cold, psychomotor exitation, starting on the first day of cycle for 90 consecutive dyskinesia, retroperitoneal fibeosis. days. Dysfunctional uterine bleeding: 2.5-10mg daily for 5-10 days commencing day 16-21 of cycle PERGOVERIS Merck Serono and given for 2 consecutive cycles. Secondary amenorrhea: 2.5-10mg daily for 5-10 days 6N commencing day 16-21 of cycle and repeated for 3 Gonadotrophins. Follitropin alfa (r-h FSH), 150IU consecutive cycles. (equiv. 11mcg) and lutropin alfa (r-h LH), 75IU Q Not applicable. (equiv. 3mcg). Powder and solvent for D History of thromboembolic disorders. subcutaneous injection. 1, A91.00; 10, A909.98. S Stimulation of follicular development in Liver dysfunction, pregnancy. B History of depression, diabetes, epilepsy, women with severe LH and FSH deficiency. migrane, asthma, cardiac or renal dysfunction. P Initially, one vial daily with additional C Aminoglutethimide. FSH if necessary. See SPC. A Thromboembolic disorders, insomnia, Q Not applicable. fatigue, rash, weight gain. D Hypothalamus and pituitary gland tumours, ovarian enlargement or cyst not due to PUREGON Schering-Plough polycystic ovarian disease, gynaecological 2NO haemorrhages, ovarian, uterine or mammary Gonadotropin. Recombinant FSH 50 IU, 100 IU, carcinoma or when an effective response cannot 150 IU, 300 IU, 600 IU, 900 IU FSH activity. Soln for be obtained (e.g. primary ovarian failure, sexual inj. in vials 0.5ml (50 IU-150 IU), or cartridges organs malformations or fibroid tumours of the 0.36ml (300 IU), 0.72ml (600 IU), 1.08ml (900 IU). uterus incompatible with pregnancy). Pregnancy, 50 IU-1, A26.55; 100 IU-1, A53.10; 150 IU-1, lactation. A79.65; 300 IU-1, A159.30; 600 IU-1, A318.60; 900 B Regularly monitor ovarian response IU-1, A477.90. with ultrasound alone or in combination with serum oestradiol levels measurements to minimise S Anovulary infertility (incl. PCOD) ovarian hyperstimulation syndrome (OHSS). hCG unresponsive to clomiphene citrate. Multifollicular administration to induce ovulation increases OHSS stimulation in superovulation for IVF/ET/GIFT and risk. Porphyria (or family history): Closely monitor. ICSI. Slightly higher prevalence of congenital P Anovulation: Initially 50 IU daily for at malformations in women with thrombo-embolic least 7 days. Monitor response; see SPC. events risk factors. Ectopic pregnancies may occur. Superovulation: Initially 100-225 IU daily for at Increased incidence of multiple pregancies and least 4 days, alone or in combination with a births. GnRH; See SPC. All by SC inj. (cartridges and vials) A Ovarian cysts, mild to severe injection or SM inj. (vials). site reactions, headache, mild to moderate OHSS, Q Not applicable. breast pain, pelvic pain, somnolence, abdominal D Pregnancy, lactation. Tumours of
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.
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 Pituitary desensitisation in preparation for ovulation induction regimes using gonadotrophins. P See data sheet. 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.
SYNAREL NASAL SPRAY
Pharmacia
6NT GnRH analogue. Nafarelin (as acetate) 2mg/ml; Clear, colourless to slightly yellow nasal spray soln. 200mcg per metered spray soln. 60 dose unit, A79.36. S Pituitary desensitisation in controlled ovarian stimulation programmes prior to IVF. P 1 spray (200mcg) to each nostril in the morning and evening until ovarian downregulation is achieved then administer gonadotrophin; see data sheet. Q Not applicable. D Discontinue at least 3 days before embryos are placed in utero. Lactation. Undiagnosed vaginal bleeding. B Patients at risk of osteoporosis. A Hot flushes, vaginal dryness, headache, changes in libido, emotional lability, myalgia, decreased breast size, irritation of nasal mucosa, small reduction in bone density.
18.1 TOXICOLOGY
ANEXATE
Roche
2N Benzodiazepine antagonist. Flumazenil 100mcg/ml. Amp. 5 x 5ml, A111.33. S Reversal of the central sedative effects of benzodiazepines. P 200mcg IV over 15 sec, with repeat doses of 100mcg until desired level of consciousness is obtained; max 1mg or 2mg in intensive care setting. As an infusion of 100400mcg/hour adjusting rate to achieve desired
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
303
18.1 TOXICOLOGY
TOXICOLOGY
be required. Driving/operating machinery. C Alcohol (admin. at least 24 hrs after last ingestion). Caution: Paraldehyde, phenytoin, barbiturates, amphetamines, morphine, diazepam, rifampicin, chlordiazepoxide, oral hypoglycaemics, courmarin anti-coagulants, metronidazole, isoniazid, chlorpromazine, amitriphyline, pimozide. ANTABUSE Actavis A Drowsiness, fatigue, headache, GI disorders, halitosis, taste disorders, reduced libido. 2MO Elevations in liver enzyme levels (transaminases Aldehyde. Disulfiram 400mg. White, flat, circular and S- GT) including icterus. effervescent tab. 50, A22.26. S Adjunct in chronic alcoholism. To be CALMAX Ergha used in conjunction with appropriate psychiatric 2NO treatment. Medium-acting benzodiazepine. Alprazolam P On 1st day 800mg in one dose. Then 0.25mg, 0.5mg, 1mg. White tab. marked ’apzm 600mg (2nd day), 400mg (3rd day), 200mg (4th and 5th day). Subsequently 200mg or 100mg daily or 2- 0.25’, pink tab. marked ’apzm 0.5’, light blue tab. marked ’apzm 1’ resp. All tabs. oblong, scored. 3 times weekly until patient restored to social 0.25mg-100, A3.38. 0.5mg-100, A6.53. 1mg-100, order. An alcohol challenge may be performed A13.64. from the fifth day of dosage onwards (see SPC). S Anxiety disorders. Q Not recommended. P 0.25-0.5mg three times daily. Max. 4mg D Decompensated cardiac disease, severe daily. hypertension, psychoses. Pregnancy, lactation R 0.25mg two or three times daily. B Caution: Renal, hepatic or respiratory Q Not recommended. disease, diabetes, mellitus, epilepsy, peripheral D See SPC. neuropathy, hypothyroidism, irreversible brain damage. On no account drink alcohol (during CAMPRAL EC Merck Serono treatment and for 1 week after cessation), unless 2MO given as challenge dose by physician. Supportive measures to counteract hypotension should be GABA analogue. Acamprosate (Ca++) 333mg. White available; a pressor agent (e.g. noradrenaline) may ent-ctd tab. marked 333. 84, A27.57. level of arousal. B Tricyclic antidepressants, epileptic patients receiving benzodiazepine treatment for prolonged periods. Pregnancy. A Nausea, vomiting, flushing, rarely seizures, transient increase in BP.
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.
304
S Adjunct to counselling to maintain abstinence in alcohol-dependent patients. P Over 60kg, 2 three times daily with meals; under 60kg, 2 in the morning, 1 at noon and 1 at night with meals. Commence treatment as soon as possible after alcohol withdrawal and maintain for 1 year. W Not recommended. D Renal insufficuency, severe hepatic failure. Pregnancy, lactation. B Not a treatment for withdrawal period. Initiation only under direct supervision of consultant or clinician experienced in the field, in a hospital clinic or alcohol treatment unit. GPs with interest in treating alcohol dependent patients are permitted to initiate or pursue Campral treatment. Monitor for symptoms of suicidality. A GI disturbances, skin reactions, impotence, altered libido.
CHAMPIX
Pfizer
2NO Partial agonist. Varenicline (as tartrate) 0.5mg, 1mg. White and light blue resp. capsular-shaped, biconvex film-ctd tab. debossed with Pfizer on one side and CHX 0.5 or CHX 1.0 on reverse. 4 week starter pack: 0.5mg -11 and 1mg -42, A70.56. 4 week, 0.5mg-56, A73.25. 4 week, 1mg continuation pack: 1mg x 56, A72.79. S Smoking cessation in adults. P 1mg, twice daily, swallowed whole with water. Titrated as follows: Days 1-3, 0.5mg once daily; days 4-7, 0.5mg twice daily and day 8 onwards, 1mg twice daily. Begin 1-2 weeks before desired quit date. If adverse effects not tolerated dose may be lowered to 0.5 mg twice daily. Duration: 12 weeks; if successful consider additional 12 week course at 1mg twice daily. Renal impairment: Moderate, dose may be reduced to 1mg once daily; severe, 1mg once daily (0.5 mg once daily for the first 3 days then, 1 mg once daily). Q Not recommended. D Pregnancy. B Smoking cessation may increase plasma 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.
DESFERAL
Novartis
2NO Chelating agent. Desferrioxamine (mesylate) 500mg. Powder in vial. 10, A36.48. S Aluminium overload: patients under maintenance dialysis for end stage renal failure with aluminium-related bone disease and/or anaemia, dialysis encephalopathy, diagnosis of aluminium overload. Iron overload: acute iron poisoning, primary and secondary haemochromatosis incl. thalassaemia and transfusional haemosiderosis, in patients in whom concomitant disorders (e.g. severe anaemia, hypoproteinaemia, renal failure) preclude phlebotomy. Treatment of corneal rust stains and ocular siderosis. Diagnosis of iron storage disease,
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
18.1 TOXICOLOGY
TOXICOLOGY
certain anaemias. V See lit. B Impaired renal function. Neurological dysfunction in patients with aluminium-related encephalopathy occurs when used alone; avoid with pretreatment with clonazepam. Local irritations may occur more frequently if given SC 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. A Shock with rapid IV inj. Rarely allergic reactions, Cardiovascular, neurological and Gl disturbances. Red colouration of urine. Lens and retinal changes. Hepatic and renal dysfunction. Blood dyscrasias. Hearing disturbances.
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.
NICORETTE GUM. Alkaloid. Nicotine 2mg, 4mg. Chewing gum. Classic/ mint/ freshmint/ freshfruit: 2mg-30, A5.75; 105, A17.98; 4mg-30, A7.18; 105, A22.01. Also: Classic: 2mg-210, A24.91 (GMS); 4mg-210, A30.74 (GMS). Mint: 2mg-210, A29.31; 4mg-210, A36.16. S Relief of nicotine craving and withdrawal symptoms, facilitating cessation in NALOXONE Antigen smokers motivated to quit or helping smokers temporarily abstain from smoking. 2N 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 regular intervals to prevent craving occurring. 10, A51.66. Chew slowly then rest to allow nicotine to be 2N absorbed. Max. 15 pieces daily. May be used for ALSO NALOXONE PAEDIATRIC Naloxone (HCl) 40 up to 3 months. mcg/ml; Soln. for inj. in a glass vial. 5, A20.81. 2O S Reversal of opioid depression, incl. that due to nalbuphine and pentazocine. Diagnosis of ALSO NICORETTE INHALER Nicotine 10mg. Inhalation cartridge plus mouthpiece. 18, A9.32; acute opioid overdosage. 42, A16.34. P Postoperatively: 100-200mcg IV at 2-3 DISTAMINE Alliance P Cessation: 3 month course. 6-12 min intervals. Additional doses may be necessary cartridges daily for 8 weeks, followed by gradual 2MO at 1-2 hr intervals. Opioid overdosage: 400reduction to zero cartridges at 12 weeks. Chelating agent. Penicillamine base 125mg, 2,000mcg IV at 2-3 min intervals. May admin. IM Abstinence: Max. 12 cartridges in 24 hours. 250mg. White film-ctd tab. marked DS and 125 or or SC if IV route cannot be used. 2 O DM and 250. 125mg-100, A12.44; 250mg-100, Q Initially 10mcg/kg body weight IV; max. A21.45. ALSO NICORETTE MICROTAB Nicotine 2mg. 100mcg/kg body weight. May admin. IM or SC if S Cystinuria, Wilson’s disease, heavy metal IV route is unavailable. Opioid depression: 10mcg/ Sublingual tab. 30 (OTC), A7.21; 105, A14.93. P Cessation: 1-2 tabs. per hour placed poisoning, chronic active hepatitis. kg body weight IV, IM or SC inj. repeated at 2-3 V See SPC. min intervals. Single IM dose of 60mcg/kg may be under the tongue; max. 40 tabs daily. Use for 3 months while gradually reducing dosage. Stop D Agranulocytosis or severe given at birth. treatment when only 1-2 tabs. are taken each day. thrombocytopenia due to penicillamine. Lupus D Pregnancy, lactation. erythematosus. Lactation. Persistent proteinuria. B Opioid dependent patients, or patients Abstinence, 1-2 tabs per hour. 2O Moderate/ severe renal impairment. Pregnancy. who have received large doses of opioids. Avoid ALSO NICORETTE INVISIPATCH Nicotine 10mg, excessive dosage following surgery. CVD, B Renal insufficiency. Monitor blood, cardiotoxic drugs, elderly. Ineffective against non- 15mg, 25mg per 16 hours. Transdermal patches. urine and renal function before and frequently 10mg-7, A10.77; 15mg-7, A10.77; 25mg-7, during treatment. Consider withdrawal if platelets opioid induced respiratory depression. Monitor A10.77. carefully. fall Q 120,000 or white blood cells Q 2,500/mm3, A GI disturbances, sweating, tachycardia, S Relief of nicotine craving and or if 3 successive falls noted within the normal fibrillation, hyperventilation, hypo/hypertension, withdrawal symptoms, facilitating cessation in range. Use antihistamines, steroid cover, or tremulousness, pulmonary oedema. smokers motivated to quit. temporary reduction of dose to control urticarial P Apply 1 patch once daily on waking and reactions. Reversible loss of taste may occur. Stop NICOPASS Clonmel removed at bedtime. Heavy smokers: Initially use treatment immediately if haematuria occurs in the 25mg patch for 8 weeks, then 15mg patch for 2 absence of renal stones or other known cause. A 2 weeks, followed by 10mg patch for 2 weeks. Light late rash may occur after several months or years Alkaloid. Nicotine 1.5mg equiv. 8.33mg nicotine smokers: Start with 15mg patch for 8 weeks and of therapy (dose may need to be reduced). Breast resinate. Opaque, square lozenge. Beige decrease to 10mg for final 4 weeks. enlargement may occur in men and women. (freshmint) or brown (liquorice mint). 12, A2.61; Q Under 18 years, not recommended Deterioration of Wilson’s disease neurological A 36, 6.92. symptoms (dystonia, rigidity, tremor, dysarthria) S Relief of nicotine withdrawal symptoms, without physician’s advice. D Non-smokers. Pregnancy (except on reported. in nicotine dependency as an aid to smoking doctors advise), lactation. C Gold salts, anti-inflammatory, oral iron, cessation. drugs known to cause bone marrow or renal P 8-12 daily for about 3 months (max. 20 B CVD, uncontrolled hypertension, severe/ moderate hepatic impairment, severe renal injury. daily), reducing gradually down to 1-2 daily then impairment, active and duodenal ulcers, A Thrombocytopenia, proteinuria. stop. Max: 6 months. hyperthyroidism or pheochromocytoma. Diabetes D Non-smoker or occasional smoker. NALOREX BMS Hypersensitivity to peanut or soya. mellitus (lower dose of insulin may be required). C Smoking cessation may alter B Recent MI, unstable or worsening 2NO pharmacokinetics of certain drugs. angina incl. Prinzmetal’s angina, severe cardiac Narcotic antagonist. Naltrexone (HCl) 50mg. arrhythmias, uncontrolled hypertensions or recent A Local irritation, headache, dizziness, GI Yellow film-ctd scored tab. marked R11 on one discomfort. Itching, erythma (patch). cerebrovascular accident (close medical side and 50 on reverse. 28 (Cal/Pk), A63.45. supervision). Caution: Stable CVD, diabetes S Maintenance therapy in detoxified, NICOTINELL Novartis Consumer mellitus, hyperthyroidism or phaeochromocytoma, formerly opioid-dependent patients. severe hepatic / renal impairment. Active 2O P Initially 25mg, then 50mg daily. Initial oesophagitis, oral or pharyngeal inflammation, Alkaloid. Nicotinell TTS10, TTS20, TTS30 providing treatment in drug addiction centre and a gastritis or peptic ulcer. Contains aspartame and 7mg, 14mg and 21mg nicotine per 24 hours. treatment period of three months should be isomalt. Pregnancy, lactation (avoid). Transdermal patch. TTS10-7, A10.54; TTS20-7, considered. C Tobacco cessation: CYP1A2 substrates A11.01; TTS30-7, A11.48; 21, A27.64. Q Under 18 years, not recommended. incl. caffeine, theophylline. Nicotine: Nifedipine, b- S Nicotine dependency as an aid to D Acute hepatitis or liver failure; blockers, insulin, diuretics, H2 antihistamines, dependence to opioids; acute opoid withdrawal; smoking cessation. oestrogen-progestagen combinations. in conjunction with an opioid-containing P Subject should be advised to stop A Slight irritation of the throat, salivation, medication; positive screening for opioids or smoking completely when starting treatment. hiccup, dizziness, headache, GI disorders. failure of the Narcan Challenge. More than 20 cigarettes per day, initially 21mg/24 B Renal or hepatic impairment. Ability to hour patch once daily; less than 20 cigarettes per NICORETTE McNeil Healthcare drive or operate machinery may be impaired. day, initially 14mg/24 hour patch once daily. 2 Pregnancy, lactation. Reduce dose at intervals of 3-4 weeks. Max.
306
2
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m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
TOXICOLOGY 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 2O ALSO NICOTINELL GUM Nicotine 2mg, 4mg. Mint waking. 3 step tereatment. Step 1 (weeks 1-6) start with 1 every 1-2 hours. Step 2 (weeks7-9) 1 or fruit flavoured chewing gum. 2mg-24, A3.34; every 2-4 hours. Step 3 (weeks 10-12) 1 every 4-8 96, A10.74. 4mg-24, A3.68; 96, A13.32. hours. Over the next 12 weeks, use 1-2 per day P Use 2mg gum if Q20 cigarettes a day only on occasions when strongly tempted to and 4mg gum if q 30 cigarettes a day; either in between. Chew each piece for 30 mins. when urge smoke. During weeks 1-6 itis recommended that to smoke; max. 25 x 2mg or 15 x 4mg pieces daily. users take a min. of 9 per day. Users should not exceed 15 per day and use for max. 24 weeks (6 Stop smoking completely. Withdraw gradually months). after 3 months. Q Not recommended. 2O ALSO NICOTINELL MINT LOZENGES Nicotine 1mg, D Non-smokers, occasional smokers. 2mg. Mint flavoured compressed lozenge. 1mg-36, Myocardial infarction, unstable or worsening angina pectoris, Prinzmetal’s angina, severe cardia A5.55; 96, A11.79. 2mg (non GMS yet)-36, A7.60; arrythmias, recent cardiovascular accident. 96, A16.13. B CVD e.g. stable angina pectoris, HF, P Use 1mg lozenge if Q20 cigarettes a cerebrovascular disease, vasospastic disease, severe day or 2mg if q 30 cigarettes a day; either in between. Suck 1 lozenge over 30 minutes every 1- peripheral disease, uncontrolled hypertension, atopic or eczemalous dermatitis, severe renal or 2 hours when urge to smoke. Usual dose 8-12 hepatic impairment or active peptic ulcers, lozenges per day, max. 30mg a day. Reduce hyperthyroidism, pheochromocytoma, insulingradually after 3 months. dependent diabetes. Q Under 18 years, not recommended C Theophylline, insulin, See SPC. without physician’s advice. A Local irritation, See SPC. D Non smokers. Patch only: Acute MI, unstable angina, severe cardiac arrhythmias, recent PARVOLEX UCB stroke, skin disease. 2N B Hypertension, angina, cerebrovascular or occlusive peripheral vascular disease, HF, Paracetamol antidote. Acetylcysteine 200mg/ml. diabetes mellitus, hyperthyroidism, Amps. containing clear colourless soln. for inf. pheochromocytoma, renal/hepatic impairment, 10ml x 10, A36.10. peptic ulcer. Oral: MI, severe cardiac arrhythmias, S Treatment of paracetamol overdose. stroke, fructose intolerance, oesophagitis, gastritis. P Admin. by IV inf. Initially, 150mg/kg Oral nicotine replacement beyond 6 months, not body weight infused in 200ml over 15 mins. recommended; beyond 9 months, seek medical Followed by, 50mg/kg infused in 500ml over next advice. Lozenges contain aspartame. Gums contain 4 hrs. Then, 100mg/kg in 1L over next 16 hrs. Total: sweeteners, incl. sorbitol. 300mg/kg in 20hrs. C Caution: Propoxyphene, furosemide, R r20kg: Initially, 150mg/kg in 100ml propranolol, nifedipine, adrenergics, H2 over 15 mins. Followed by, 50mg/kg in 250ml over antagonists. Smoking cessation decreases CYP1A2 4 hrs. Then 100mg/kg in 500ml over 16 hrs. Under activity. 20kg: Infusion volumes responsibility of prescriber. A Headache, dizziness, GI disorders, dry D Pregnancy (assess risk/benefit). mouth. Jaw muscle ache (gum). Local skin B Asthma, history of bronchospasm. Liver reactions (patch). enzyme inducing drugs, chronic alcohol abuse (consult treatment normogram). NIQUITIN CQ GSK A Anaphylactoid, hypersensitivity-like reactions. 2O Alkaloid. Nicotine 21mg, 14mg, 7mg per 24 hrs. GSK Transdermal patches. 21mg-1 week kit, A11.86; 2 PHYMET DTF week kit, A21.38; 14mg-1 week kit, A11.86; 7mg- 0 L 1 week kit, A11.86. Opiate. Methadone HCl, 1mg/ml. Clear green S Relief of nicotine withdrawal symptoms viscous oral solution. incl. craving associated with smoking cessation. S Opioid drug addictions (as narcotic Should be used with the CQ behavioural support abstinence syndrome suppressant), as substitution programme which is available free. or maintenance therapy, within broader treatment P Users should stop smoking completely protocol/programme, accompanied by regular during a cessation attempt. No other form of reviews and reassessment. nicotine should be taken at the same time. More P Initially 10-20mg by mouth. Increase as than 10 cigarettes, initially 21mg/24 hrs patch once necessary by 10-20mg daily until there are no daily for 6 weeks. Reduce dose to 14mg/24 hrs for signs of withdrawal or intoxication. After 2 weeks followed by 7mg/24 hrs for last two stabilisation (often achieved with 40-60mg daily), weeks. Those who smoke Q 10 cigarettes per day gradually decrease until total withdrawal start with 14mg/24 hrs for 6 weeks followed by achieved. Renal impairment: Caution. GFR 107mg/24 hrs for final two weeks. Max treatment 50ml/min, dosage interval 8 hourly minimum; period 10 consecutive weeks. Patches may be GFRQ10ml/min, dosage interval 12 hourly removed before going to bed. However use for 24 minimum. Hepatic impairment: Use less than hrs is recommended. normal recommended dose, using patient’s Q Not recommended. response as guide. 2O R Careful monitoring advised. ALSO NIQUITIN CQ MINT LOZENGE Nicotine 2mg, Q Not recommended. 4mg. White lozenges marked NL2 or NL4. 2mg-36, D Respiratory depression (esp. cyanosis, A9.01; 72, A14.73; 4mg-36, A9.01; 72, A14.73. excessive bronchial secretions), bronchial asthma treatment period 3 months. Apply patch to non hairy area of skin on trunk or upper arm. Do not remove at night.
TOXICOLOGY 18.1 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.
PINADONE DTF
Pinewood
0L Opiate. Methadone (HCl) 1mg/ml; sugar-free liquid. 500ml, A12.70. S Opioid addiction as substitution or maintenance therapy, within a broader treatment protocol/programme accompanied by regular reviews and reassessment. P Initially 10-20mg daily, increasing by 1020mg daily until there are no signs of withdrawal or intoxication. Usually 40-60mg daily. See SPC.Treatment must be supervised by specialist services. Q Not recommended. D Respiratory disease, obstructive airways disease. Obstetrics. B Pregnancy. Impaired liver or kidney function. C MAOIs, CNS depressants. A Nausea, vomiting, constipation, drowsiness, blurred vision, dizziness.
PROTAMINE SULPHATE LEO PHARMA LEO Pharma 2NO Heparin antagonist. Protamine sulphate 1400 antiheparin IU/ml (equiv. 10mg/ml). Preservative free. Amp. 5 x 5ml, A43.02. S Heparin or tinzaparin antidote. P 1ml (10mg) neutralises 1,400 IU of heparin. 1ml (10mg) partially neutralises 1,000 anti-Xa IU LMWH (tinzaparin). B Excessive dosage may prolong the coagulation time, thrombocytopenia. Pregnancy, lactation. A Anaphylactic reactions.
REVIA
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
BMS
307
19.1 DIAGNOSTIC
DIAGNOSTIC
AGENTS
2NO Narcotic antagonist. Naltrexone (HCl) 50mg. Pale yellow, film-ctd, cap.-shaped tab. scored and marked R11on one side, 50 on reverse. 28, A62.09. S For use with a comprehensive treatment programme for alcohol dependence to reduce the 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.
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.
33.3mmol/l range. Suitable for use only with AccuChek Advantage meter.
ACCU-CHEK AVIVA
Roche Diagnostics
OU Test strip. 50, A22.10.
U ALSO ACCU-CHEK AVIVA CONTROLS 1, A11.35.
U
GSK ALSO ACCU-CHEK SYSTEM 1, price available on
ZYBAN 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. SUBUTEX Schering-Plough D Current/history of seizure disorder, bulimia, anorexia nervosa, severe hepatic cirrhosis, 0JL bipolar disorder, CNS tumour, abrupt alcohol/ Opiate. Buprenorphine (HCl) 0.4mg, 2mg, 8mg. benzodiazepines withdrawal. Pregnancy, lactation. Sublingual tab. Prices on request. S Substitution treatment for major opioid B Predisposition to lowered seizure threshold/increased risk of seizures (previous head drug dependence, within a comprehensive injury, medications lowering seizure threshold, therapeutic monitoring framework of medical, diabetes, stimulant use or anorectic products), use social and psychological treatment. if benefit outweighs risk (max. 150mg daily). P Initially 0.8-4mg single daily dose Hypertension, depressed mood, hypersensitivity. sublingually. The dose should be increased C Contra: MAOIs (irreversible, 14 days progressively up to max. 32mg single daily dose. apart; reversible, 24 hrs). Alcohol, avoid. Caution: After stabilisation reduce gradually to a lower Substrates of CYP2D6 (antidepressants, maintenance dose; when deemed appropriate, antipsychotics, b-blockers, type 1C antiarrhythmics) treatment may be discontinued. or CYP1A2, orphenadrine, cyclophosphamide, Q Under 15 years, not recommended. ifosfamide, metabolism inducers/inhibitors, D Severe respiratory or hepatic insufficiency, acute alcoholism or delirium tremens, levodopa or amantadine. A Dry mouth, GI abdominal disorders, acute asthma attack, head injury, increased insomnia, tremor, concentration disturbance, intracranial pressure. Lactation. 2nd and 3rd headache, dizziness, depression, agitation, anxiety, trimester of pregnancy. rash, pruritus, urticaria, sweating, fever, taste B Hepatitis, hypotension, prostatic disorders. hypertrophy, urethral stenosis, asthma or respiratory insufficiency, renal or hepatic 19.1 DIAGNOSTIC AGENTS insufficiency. Driving, using machines. C Alcohol. Caution: Benzodiazepines, ACCU-CHEK ACTIVE Roche Diagnostics other CNS depressants, other opioid derivatives, OU certain antidepressants, sedative H1-receptor A antagonists, barbiturates, anxiolytics, neuroleptics, Test strip. 50, 23.00. U clonidine, MAOIs. ALSO ACCU-CHEK ACTIVE GLUCOSE CONTROLS 1, A Constipation, headache, insomnia, A11.35. asthenia, drowsiness, nausea, vomiting, fainting, U dizziness, orthostatic hypotension, sweating. ALSO ACCU-CHEK ACTIVE SYSTEM 1, price XANAX Pharmacia available on request. S Detection of blood glucose levels in 0.62NO 33.3mmol/l range, test time 10 secs. Suitable for Medium-acting benzodiazepine. Alprazolam use with Glucotrend meters. 0.25mg, 0.5mg, 1mg. White, pink and lavender oval scored tabs. marked UPJOHN 29, UPJOHN 55 ACCU-CHEK ADVANTAGE PLUS and UPJOHN 90 resp. 0.25mg-100, A3.52; 0.5mgRoche Diagnostics 100, A6.77; 1mg-100, A14.13. OU S Anxiety when the disorder is severe, Test strip. 50, A23.00. disabling or causing extreme distress. U P 0.5-1mg daily in divided doses, ALSO ACCU-CHEK ADVANTAGE II CONTROLS 1, increasing in increments not greater than 1mg A11.35. every 3-4 days to 3-4 daily. Max. treatment U duration, 8-12 weeks. R 0.25mg twice daily. ALSO ACCU-CHEK ADVANTAGE SYSTEM 1. Price available on request. Q Not recommended. S Detection of blood glucose levels in 0.6D Myaesthenia gravis, severe respiratory
308
AGENTS
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.
ACCU-CHEK COMPACT Roche Diagnostics
OU Test strip. 51 (3 x 17), A23.19.
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.
ACCU-CHEK MULTICLIX Roche Diagnostics
OU Blood lancet 0.3m/30 gauge. 200 (+4), A12.62. S Suitable for use with Accu-Chek Multiclix finger pricker.
ACCU-CHEK SOFTCLIX Roche Diagnostics
OU Blood lancet 0.4 mm/28 gauge. 200, A10.30. S Suitable for use with Softclix finger pricker.
ACETEST
Siemens Diagnostics
OU Tablet. 100, A5.52. S Detection of ketones in urine, plasma and serum.
ALBUSTIX
Siemens Diagnostics
OU Test strip. 50, A6.06. S Detection of protein in urine.
BM-ACCUTEST
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
Bayer HealthCare
OU 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
2
5
m
c
s
b
d
Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
Omega
DIAGNOSTIC
DIAGNOSTIC
AGENTS
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
AGENTS
19.1
6U Diagnostic. Gonadorelin 0.1mg. Powder and solvent for soln. for inj. in single unit vial. 1, A
Bayer HealthCare 22.61.
S Evaluation and assessment of the functional capacity and response of gonadotrophic CLINISTIX pituitary reserve of luteinising hormone and follicle stimulating hormone in patients with OU possible impairment of pituitary function or DRUG SCREEN Omega Test strip. 50, A4.89. hypothalamopituitary function. U S Detection of glucose in urine. 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 CLINITEST Bayer HealthCare S Simultaneous rapid testing for 10 1-7). different drugs of abuse: amphetamines, OU Q Under 1 year, not recommended. barbiturates, benzodiazedines, cocaine, Tablet. Pocket set-1, A6.29; Refills-36, A3.13. D Pregnancy, lactation. methamphetamine, methadone, opiates, TCAs, S Estimation of reducing substances in C Drugs affecting pituitary gonadotrophin THC, phencyclidine. urine. production incl. oestrogens, progestogens, U androgens and glucocorticoids. Digoxin, COMBINA Omega ALSO DRUG SCREEN 2 10 test cards, A164.32. phenothiazines, levodopa, spironolactone and S Simultaneous rapid testing for 5 OU dopamine. different drugs of abuse: cocaine, THC, Urine test strips. 50 strips, A11.81. benzodiazepines, methadone, opiates. HEMA-COMBISTIX Siemens Diagnostics S Detection of; glucose, ketone, nitrates, U pH, specific gravity, bilirubin, urobilinogen, OU ALSO DRUG SCREEN 1 10 test cards, A164.32. protein or blood in urine Test strip. 50, A19.51. S Simultaneous rapid testing for 5 OU S Detection of pH, glucose, protein, blood different drugs of abuse: amphetamines, ALSO COMBINA 3 50 strips, A6.60. in urine. barbiturates, benzodiazepines, S Detection of protein, pH, glucose in U opiates,methamphetamine. urine ALSO HEMASTIX 50, A15.55. U FREESTYLE LITE Abbott S Detection of blood in urine. ALSO COMBINA 2 50 strips, A5.21. OU S Detection of glucose and ketones in HEXAGON Omega Blood glucose monitoring systems. FreeStyle Lite: urine. U No Coding Required. Small meter using 0.3mcl OU blood sample. Coulometric technology. Average 5 Rapid test. 20 tests, A80.00. ALSO COMBINA GLUCOSE 50 strips, A4.19. S Detection of anti-bodies to Helicobacter sec. test time. Backlit for easy testing day and S Detection of glucose in urine pylori in whole blood/serum or plasma. night. 400 reading memory. FreeStyle Freedom COMBUR-3 TEST Roche Diagnostics Lite: No Coding Required. Blood sample of 0.3mcl KETO-DIABUR TEST Roche Diagnostics required. Average 5 sec. test time. Larger, easy to U OU use buttons. Curved shape comfortable to hold. Test strip with 3 test areas. 50 strips, A8.43. Freestyle Lite test strips only to be used with Test strip with 2 test areas. 50, A8.14. S Detection of pH, protein and glucose in Freestyle Lite/Freedom Lite meters. Freestyle Lite/ S Quantitative estimation of ketone and urine. Freedom Lite blood glucose monitoring systems, glucose in urine. OU prices on request; Freestyle Lite test strips, A21.25; ALSO COMBUR-5 TEST D 50, A11.97. Freestyle Lancets, A8.29. KETO-DIASTIX Bayer HealthCare S Detection of pH, protein, ketone, S Monitoring of blood glucose in the OU glucose and blood in urine. range of 1.1-27.8mmol/L. Test strip. 50, A7.29.
OU
Test strip. 50, A4.16. Siemens Diagnostics S Detection of glucose in urine.
OU
ALSO COMBUR-7 TEST 100, A23.73. S Detection of pH, leucocytes, nitrite, protein, glucose, ketones and blood in urine.
OU A19.78;
A28.52.
GLUCOMEN
A. Menarini Diagnostics
U 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.
ALSO COMBUR-9 TEST 50, 100, S Detection of nitrite, pH, protein, glucose, ketone, urobilinogen, bilirubin, blood and U leucocytes in urine. ALSO GLUCOMEN LANCETS FINE Longitudinally OU fluted cylindrical mount 0.45mm 26 gauge. 200, A8.29. ALSO COMBUR-10 TEST 100, A37.31. S Detection of specific gravity, pH, S For use with GlucoJect Plus 2 Pen. leucocytes, nitrite, protein, glucose, ketones, GLUCOMETER ELITE TEST urobilinogen, bilirubin and blood in urine.
CONTOUR
Bayer HealthCare
OU Blood Glucose Monitoring System. With No 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
SENSORS
Bayer HealthCare
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.
GLUCOSTIX
Test strip with 1 test area. 50 strips, A4.04.
OU
H.R.F
KETOSTIX
Bayer HealthCare
OU Test strip. 50, A4.41. S Detection of ketones in urine, plasma and serum.
KETUR TEST
Roche Diagnostics
OU Test strip with 1 test area. 50, A3.89. S Detection of ketones in urine.
LABSTIX
Siemens Diagnostics
OU Test strip. 100, A32.23. S Detection of pH, protein, glucose, ketones and blood in urine.
OU
Siemens Diagnostics ALSO LABSTIX SG 100, A32.24.
Test strip. 50, A24.77. S Semi-quantitive estimation of blood Roche Diagnostics glucose. Visual or meter reading.
OU
S Detection of ketones and glucose in urine.
S Detection of pH, protein, glucose, ketones, blood and specific gravity in urine.
MICRAL-TEST
Roche Diagnostics
OU Intrapharm Labs. Test strip. 30, A52.50.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
309
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
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.
S Rapid detection of microalbuminuria in urine.
MICROALBUSTIX OU
Test strip. 25, A52.64. S Detection of albumin and creatinine in urine; provides a semi-quantitative albumin/ creatinine ratio. Test time 1 min.
MICROLET
Bayer HealthCare
OU 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.
OU
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.
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
QED
Omega
U Rapid test. A130.71, 10 tests. S Determination of alcohol in saliva.
RAPIGNOST BASIC SCREEN PLUS Advance Test strip. 100, A15.00. S Rapid determination of ascorbic acid, glucose, protein, blood, pH and nitrites in urine.
OU ALSO MULTISTIX GP 25, A10.32. S Detection of glucose, ketones, specific gravity, bleed, pH, protein, nitrites and leucocytes.
OU ALSO RAPIGNOST DIABETES PROFILE 50, A6.90. S Rapid determination of ketones, ascorbic acid and glucose in urine.
N LABSTIX
Siemens Diagnostics O U
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 Siemens Diagnostics ascorbic acid in urine.
Test strip. 100, A37.64. S Detection of pH, protein, glucose, ketones, blood and nitrite in urine.
N MULTISTIX SG OU
REFLOTRON PLUS
Test strip. 100, A44.28. S Detection of pH protein glucose, ketones, bilirubin, blood, nitrite and specific gravity in urine.
Roche Diagnostics
U
Quantitative diagnostic. The system features an integrated multifunctional Cardiac Risk Assessment programme. Samples are applied directly to preNMP22 BLADDERCHEK RB-Medical calibrated test strips with results being available within 2-3 mins. Price available on request. U S Quantitative determination of 16 clinical Point of care test. Test cassette for urine sample. chemistry parameters in whole blood, serum or Box of 24 test kits, A552.00 (A23.00 per test kit). plasma. S Screening for bladder cancer.
TESTPACK hCG-URINE OMEGA 1-STEP PREGNANCY TEST Omega U 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
Abbott
Immunoassay. Double monoclonal antibody immunoassay. Test kits, 20, A59.68. S Pregnancy testing.
THINPREP PAP TEST
Cytyc
Omega U
Lancet. 200, A8.29. S Suitable for use with a number of finger pricking devices such as Autoclix, Soft Touch, Autolet, Penlet, Glucolet.
Diagnostic. Approved replacement for Conventional Pap Smear. S Cervical screening with further testing from the ThinPrep vial (e.g. additional cytology preparations, HPV testing).
ONETOUCH RANGE
TODAY OVULATION TEST
OU
Omega
U
OU
310
Lifescan
Siemens Diagnostics
OU
OU
ALSO MULTISTIX SG 100, A36.69. S Detection of pH, protein, glucose, ketones, bilirubin, blood and urobillinogen.
URISTIX
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 Siemens Diagnostics Thin lancets, A8.23. S Monitoring of blood glucose and blood ketones.
MULTISTIX 10 SG
Diagnostic agent. 7-Tests, A17.78. S Detection of an increase in LH in female urine
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.
ACTAVIS GEMCITABINE
Actavis
2JN Nucleoside analogue. Gemcitabine (as HCl) 200mg, 1g. Concentrate for soln for inf. Prices on request. S Locally advanced or metastatic bladder
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
cancer in combination with cisplatin. Locally advanced or metastatic adenocarcinoma of pancreas. In combination with cisplatin, 1st line treatment of locally advanced or metastatic nonsmall cell lung cancer (NSCLC). Monotherapy can be considered in elderly patients or those with 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.
Pregnancy and lactation. Bilirubin q3 x ULN, severe bone marrow failure, WHO performance status q 2. B Monitor complete blood cell counts weekly. Perform liver function tests at baseline and before each cycle. Antiemetics recommended 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.
A Infection (UTI, RTI), myelosuppression, neutropenia, anaemia, thrombocytopenia, leucopoenia, bleeding, minor hypersensitivity reactions, neurotoxicity (peripheral neuropathy), bradycardia, hypotension, GI disturbances, alopecia, arthralgia, myalgia, inj. site reactions, severe elevation in AST and alkaline phosphatase.
AFINITOR
Novartis
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 S Ovarian cancer: 1st line treatment of impairment: 5mg daily. advanced ovarian cancer or with residual disease Q Under 18 years, not recommended. (q1cm), in combination with cisplatin. 2nd line D Pregnancy, lactation. treatment of metastatic ovarian cancer where B May occur: Non-infectious pneumonitis platinum therapy has failed. Breast cancer: (advise to promptly report new or worsening Adjuvant treatment of node-positive breast respiratory symptoms; discontinue if severe), 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, ACTAVIS IRINOTECAN Actavis antihistamines and H -antagonists. Immunomodulator. Imiquimod 5%. Cream in 2 2JN 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 Topoisomerase 1 inhibitor. Irinotecan HCl (sBCCs). Actinic keratoses (AKs) on face or scalp in trihydrate 20mg/ml. Concentrate for soln for inf. contraception up to 1 month after treatment for immunocompetent adult patients when size or S Advanced colorectal cancer, in women and 6 months for men), lactation. KS: number of lesions limit efficacy and/or combination with 5-fluorouracil and folinic acid in Serious uncontrolled infections. patients without prior chemotherapy. B Caution: Hepatic impairment (if severe, acceptability of cryotherapy and other topical treatments are contraindicated/less appropriate. Monotherapy if established 5-fluorouracil do not use). Discontinue if significant containing treatment regimen failed. hypersensivity reactions occur. Monitor blood P sBCCs: Apply 5 times per week for 6 P Monotherapy: 350mg/m2 as an IV inf. counts. May occur: Cardiac conduction weeks at bedtime, and leave for approx. 8 hrs. abnormalities (monitor), pseudomembranous over 30-90 min every three weeks. Combination AKs: Apply 3 times per week for 4 weeks at 2 colitis, interstitial pneumonitis, severe mucositis therapy: 180mg/m every 2 weeks by IV inf. over bedtime and leave for approx. 8 hrs. Assess after a 30-90 min followed by inf. with folinic acid and 5- (KS). Contains ethanol, macrogolglycerol 4-week treatment-free period. If any lesions ricinoleate. fluorouracil. Impaired hepatic function: See SPC. persist, repeat treatment for another 4 weeks. C Caution: Inducers or inhibitors of Q Not recommended. Max dose: 1 sachet. Max duration: 8 weeks. CYP3A4 or CYP2C8 (see Appendix I). D Chronic IBD, bowel obstruction. Q Not recommended. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
311
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
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 ALIMTA Lilly folic acid (at least 5 doses in the 7 days prior 1st Alimta dose) and vit. B12 (IM inj.) to reduce 2JN treatment-related toxicity. Adequate anti-emetic Folic acid analogue. Pemetrexed 500mg (as treatment and hydration required. cc Q45ml/min pemetrexed disodium). Powder for concentrate for (not recommended). Serious renal events, colitis, soln for inf. Vial, price available on request. interstitial pneumonitis, radiation pneumonitis S In combination with cisplatin for reported. Clinically significant third space fluid. treatment of chemotherapy naive patients with Males advised not to father child during treatment unresectable malignant pleural mesothelioma. In and up to 6 months thereafter. Driving/ using combination with cisplatin for 1st-line treatment of machines. patients with locally advanced or metastatic nonC Live attenuated vaccines, not small cell lung cancer (NSCLC) other than recommended. Avoid NSAIDS (5 days prior and 2 predominantly squamous cell histology. As days after). Caution: Nephrotoxic drugs or monotherapy for maintenance treatment of locally substances tubularly secreted (eg, probenecid, advanced or metastatic NSCLC other than penicillin), oral anticoagulants, radiation, predominantly squamous cell histology in patients radiosensitising agents. A Decreased neutrophils, leucocytes, whose disease has not progressed immediately granulocytes, Hb, platelets. GI disorders, following platinum-based chemotherapy (1st-line conjunctivitis, fatigue, fever, dehydration, treatment should be platinum doublet with neuropathy-sensory, taste disturbance, creatinine gemcitabine, paclitaxel or docetaxel). As elevation, cc decreased, rash/desquamation, monotherapy for 2nd-line treatment of patients alopecia, increased AST/ALT. with locally advanced or metastatic NSCLC other B Avoid: Open wounds, 1cm of eyelids, nose, lips or hairline. Do not use occlusive dressings. Caution: Autoimmune conditions, organ transplant patients. Protect from sun. Use for previously treated tumours (not recommended). Rarely, intense local inflammatory reactions may occur. Pregnancy. Contains methyl/ propylhydroxybenzoate, cetyl/stearyl alcohol. A Local skin reactions, skin colour changes, infection, pustules, back pain, lymphadenopathy.
ALKERAN MIMS Ireland current policy for drug inclusion
GSK
2NO Alkylating agent. Melphalan 2mg. White film-ctd tab. coded GXEH3 one side, A on reverse. 25, A12.31.
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 Symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy. P 500mcg once every three weeks by SC inj; if response inadequate after 9 weeks, further therapy may not be effective. Alternatively, 2.25mcg/kg once weekly. Continue therapy for approx. 4 weeks after end of chemotherapy. Hb should not exceed 13g/dl. Reduce the dose by 2550% once target achieved or if rise in Hb is q2g/ dl in 4 weeks. 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.
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, ALSO ALKERAN INJECTION Melphalan 50mg. Vial. A242.63. 1, A62.10. S Tumour-induced hypercalcaemia (TIH) and tumour-induced osteolysis (TIO). Paget’s ANDROCUR 100 Bayer Schering disease of bone. P TIH: Total dosage is determined by 2NO Anti-androgen. Cyproterone (acetate) 100mg. Off- patient’s initial plasma Ca++ levels. Single IV inf. of 30-60mg over 2-4 hours is adequate for mild white cap.-shaped scored tab. marked LA each hypercalcaemia. Severe hypercalcaemia requires side of score, hexagon on reverse. 60, A82.14. 90mg. TIO: Initially single IV inf. of 30mg weekly S Prostatic carcinoma. adjusting after reassessment of the patient. P Prostatic carcinoma, monotherapy: Paget’s: 180mg IV inf., as 30mg once weekly for 6 100mg two or three times daily. Reduction of weeks or initial 30mg dose followed by 60mg LHRH agonist tumour flare: initially 100mg twice daily alone for 5-7 days, followed by 100mg twice every other week over 3 weeks. Max. 360mg, can repeat every 6 months if required. Dilute before daily for 3-4 weeks, with LHRH agonist in dosage use. Do not give as a bolus inj. recommended by manufacturer. Elimination of Q Not recommended. effect of adrenocortical androgens with LHRH B Pregnancy. Severe renal insufficiency. agonist/orchiectomy: 100mg once or twice daily. Possibility of precipitating convulsions due to D Acute liver disease. Malignant/wasting electrolyte changes. diseases (other than prostatic carcinoma); severe C Infusion solutions containing Ca++, chronic depression; history of thrombosis/ embolism. Age Q 18 or incomplete bone/testicular hypocalcaemic therapy, other bisphosphonates, plicamycin. development. A Asymptomatic hypocalcaemia. Mild B See SPC. transient pyrexia. Transient lymphocytopenia. C See SPC. Oliguria. A See SPC.
2N
The current editorial policy in MIMS Ireland is to include only drugs with Product Authorisations (PA number) or unlicensed drugs that are GMS reimbursed. Consequently, all drugs 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.
312
ARANESP
Amgen
ARIMIDEX
AstraZeneca
5NT
5NO
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/
Aromatase inhibitor. Anastrozole 1mg. White biconvex film-ctd. tab. embossed with logo on one side and strength on reverse. 28, A89.08. S Treatment of early breast cancer in hormone receptive post-menopausal women.
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
recommended. Consider use of allopurinol in hyperuricemia. Elderly, increased rates of neurological adverse events. Known to be genotoxic to mammalian cells. Contains Na+. Pregnancy, lactation (not recommended). C Immunisations with live organism vaccines, adenosine deaminase inhibitors. A Infection, tumour lysis syndrome, febrile neutropenia, neutropenia, leukopenia, thrombocytopenia, anaemia, hypoglycaemia, hypocalcaemia, hypomagnesaemia, hypokalaemia, anorexia, confusional state, seizures, amnesia, somnolence, hypoesthesia, paresthesia, ataxia, balance disorder, tremor, dizziness, headache, dysgeusia, blurred vision, hypotension, pleural effusion, wheezing, dyspnea, cough, GI disorders, hyperbilirubinaemia, increased transaminases/AST increased, muscle weakness, myalgia, arthralgia, back pain, pain in extremity, blood creatinine AROMASIN Pharmacia increased, oedema, gait abnormal, oedema peripheral, pyrexia, pain, fatigue, asthenia. 5NO Irreversible aromatase inhibitor. Exemestane 25mg. AVASTIN Roche Round, biconvex, white ctd tab. marked 7663. 30, 2JN A135.00. S Adjuvant treatment of post-menopausal Monoclonal antibody. Bevacizumab 25mg per ml. Concentrate for soln for inf. in 100mg and 400mg women with oestrogen receptor positive invasive vials. Price available on request. early breast cancer, following 2-3 years of initial S In combination with fluoropyrimidineadjuvant tamoxifen therapy. Advanced breast based chemotherapy for treatment of metastatic cancer in post-menopausal women where disease carcinoma of the colon or rectum. In combination has progressed following anti-oestrogen therapy. with paclitaxel for 1st-line treatment of breast P 1 daily preferably after meal. Early breast cancer, continue until completion of 5 years cancer. In addition to platinum-based sequential adjuvant hormonal therapy (tamoxifen chemotherapy for 1st-line treatment of unresectable advanced, metastatic or recurrent followed by Aromasin) or tumour relapse. non-small cell lung cancer (NSCLC) other than Advanced, continue until tumour progression. predominantly squamous cell histology. In Q Not recommended. combination with interferon a-2a for 1st line D Pre-menopausal women. Pregnancy, treatment of advanced and/or metastatic renal cell lactation. cancer (mRCC). B Caution: Hepatic/ renal impairment; P Colon: Either 5mg or 10mg/kg BW once osteoporosis (or at risk of), assess bone mineral every 2 weeks, or 7.5mg or 15mg/kg once every 3 density before use. Contains sucrose, methyl-pweeks Breast: 10mg/kg once every 2 weeks or hydroxybenzoate. Hepatitis/ cholestatic hepatitis 15mg/kg once every 3 weeks as IV inf. NSCLC: reported. 7.5mg/kg or 15mg/kg once every 3 weeks as IV inf. C Oestrogen-containing drugs (contra). in addition to platinum-based chemotherapy for CYP3A4 substrates and inducers (caution). up to 6 cycles followed by Avastin as single agent. A Anorexia, hot flushes, depression, mRCC: 10mg/kg once every 2 weeks as IV inf. headache, GI disorders, fatigue, sweating, rash, General: 1st inf. over 90 mins; if well tolerated alopecia, joint/ musculoskeletal pain, dizziness, carpal tunnel syndrome, pain, peripheral oedema. 2nd inf. over 60 mins and subsequent infs. over 30 mins. Admin. 1st dose following chemotherapy, ATRIANCE GSK and subsequent doses before or after chemo. Q Children and adolescents, not 2J recommended. Nucleoside analogue. Nelarabine 5mg/ml. Soln for D Untreated CNS metastases. Pregnancy, inf. 6-50ml, price available on request. lactation. S T-cell acute lymphoblastic leukaemia B Wound healing complications. and T-cell lymphoblastic lymphoma whose disease Hypertension; monitor BP. Monitor for proteinuria has not responded to or has relapsed following prior to and during therapy. Caution: Intratreatment with at least two chemotherapy abdominal inflammation, elderly or history of regimens. arterial thromboembolic events, congenital P 1,500mg/m2 intravenously over 2 hours bleeding diathesis or acquired coagulopathy, CHF, on days 1, 3 and 5 and repeated every 21 days. prior anthracycline exposure or prior radiation to 2 Q Under 16 years: 650mg/m intravenously chest wall. Increased risk of tumour-associated over 1 hour daily for 5 consecutive days, repeated haemorrhage, fistula. Renal and hepatic impairment (not studied). Women must use every 21 days. Over 16 years: As per adults. contraceptive measures and not breast feed up to B Severe neurological events, 6 months following therapy. demyelination events, and ascending peripheral A Peripheral sensory neuropathy, neuropathies have been reported. Close headache, fatigue, syncope, CHF, tachycardia, GI monitoring for neurological events is strongly disorders, pain, hypertension, GI perforations, recommended (discontinue at the first sign of haemorrhage, arterial thromboembolism, palmarevents of NCI CTCAE Grade 2 or greater). plantar, muscular weakness, proteinuria, UTI. Concomitant intrathecal therapy and/ or Leucopenia, thrombocytopenia, neutropenia. craniospinal irradiation is not recommended (increased risk of neurotoxicity). Perform complete BICALINN Helsinn Birex blood counts regularly. IV hydration
Treatment of advanced breast cancer in post menopausal women. P 1mg once daily. No dose change in renal or hepatic impairment. Q Not recommended. D Pregnancy, lactation. B Children/pre-menopausal women (safety 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.
NEOPLASTIC DISORDERS 20.1 2T Anti-androgen. Bicalutamide 50mg. White round biconvex film-ctd tab. 28, A123.53. S Advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. P 50mg once daily. Start treatment at the same time as commencing treatment with LHRH analogue or surgical castration. D Females and children. B Caution: Moderate to severe hepatic impairment. Consider periodic liver function monitoring. Discontinue if severe hepatic changes occur. Contains lactose. C Coumarin anticoagulants. A Breast tenderness, gynaecomastia, GI disorders, hepatic changes (elevated transaminases levels, jaundice), hot flushes, asthenia, pruritus.
BICALUTAMIDE TEVA
Teva
2NT Anti-androgen. Bicalutamide 50mg. White to offwhite biconvex, film-ctd tab., debossed with 93 one side and 220 the other. 28, A107.67. S Advanced prostatic carcinoma in 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
BMS
2NO 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).
BILUTA
Rowex
2NT Anti-androgen. Bicalutamide 50mg. White round film-ctd tab. 28, A103.95. S Advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. P 50mg once daily. Start treatment either 3 days before or concomitantly with LHRH analogue treatment, or concomitantly with surgical castration. Q Not recommended. B Caution: Moderate to severe hepatic impairment, severe renal impairment. Consider periodic liver function monitoring. Discontinue if severe hepatic changes occur. Contains lactose.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
313
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
(pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Treatment of tumour-induced hypercalcaemia with or without metastases. P Prevention of skeletal events: 6mg IV given every 3-4 weeks by 1 hour infusion. Tumourinduced hypercalcaemia: Severe, 4mg as single dose. Moderate, 2mg as single dose. Q Not recommended (insufficient evidence). BONDRONAT Roche D Bisphosphonate hypersensitivity (IV form). Pregnancy. 2N B Dysphagia, oesophagitis, oesophageal or Bisphosphonate. Ibandronic acid (Na+ monohydrate ) 50mg. White to off-white, oblong, gastric ulcers, pain on swallowing, retrosternal pain, heartburn. Contains lactose (oral form). film-ctd tabs. engraved L2/IT. 28, A302.68. Monitor renal function, serum Ca++, phosphate S Prevention of skeletal events and magnesium. Severe hepatic insufficiency (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with (insufficient data), lactation. C Products containing Ca++, aluminium, breast cancer and bone metastases. magnesium, iron. NSAID, aminoglycosides. P 50mg daily taken after an overnight fast (at least 6 hours); before first food or drink of A Oral: Hypocalcaemia, GI disturbances, asthenia. IV: Prevention of skeletal events: the day. Medicinals and suppl. (incl. Ca++) should Infection, parathyroid disorders, headache, be avoided prior to dosing. Fasting should be continued for at least 30 minutes after taking the dizziness, taste perversion, cataracts, bundle branch block, pharyngitis, GI disorders, musculotab.. Plain water may be taken at any time. tabs. skeletal and skin disorders, asthenia, flu-like should be swallowed whole with a full glass of plain water (180-240ml) with the patient standing/ illness, peripheral oedema, thirst, elevated creatinine and gamma-GT. IV: Treatment of sitting in an upright position. Patients should not tumour-induced hypercalcaemia: Hypocalcaemia, lie down for 60 minutes after dosing. bone pain, pyrexia. 2J ALSO BONDRONAT IV Ibandronic acid (Na+ BONEFOS Bayer Schering monohydrate) 2mg/2ml. Ampoules/vials containing 2MT clear colourless soln. for infusion. 2mg/2ml-1 vial, A145.48; 2mg/2ml-5 ampoules, A727.41. Bisphosphonate. Sodium clodronate 800mg. White oval scored film-ctd tab. marked L134. 800mg-60, S Prevention of skeletal events
C Drugs with narrow therapeutic index (terfenadine, astemizole, cisapride, cyclosporin, Ca++ channel blockers), cimetidine, ketoconazole, coumarin anticoagulants. 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.
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. 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.
BUSILVEX
Pierre Fabre
2N Alkylating agent. Busulfan 6mg/ml; after dilution: 0.5mg/ml. Concentrate for soln for inf. S Conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT). Followed by cyclophosphamide (BuCy2) in adults, and by cyclophosphamide (BuCy4) or melphalan (BuMel) in paediatric patients. P 0.8mg/kg BW as a 2-hour inf. every 6 hours over 4 consecutive days for a total of 16 doses. Followed by cyclophosphamide at 60mg/kg/
Anti-doping: A Guide for Prescribers Classifications
2.......... This medicinal product is permitted for use in sport. 5.......... This medicinal product contains substance(s) prohibited for use in sport. Athletes requesting to use this product are required to apply for a TUE. m.....
c..... s........ d.......
This medicinal product contains substance(s) prohibited for use in sport, in men only. Male Athletes requesting to use this product are required to apply for a TUE. This medicinal product contains substance(s) prohibited for use in sport during the competition period only. Athletes requesting to use this product in-competition are required to apply for a TUE. 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. This medicine is permitted but should be declared on the Doping Control Form at the time of testing. 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 â&#x20AC;&#x201C; 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.
b........
*All TUE applications for asthma medications must be accompanied with a medical file meeting the minimum requirements as defined by WADA (refer to www.irishsportscouncil.ie/Anti-Doping) and must reflect current best medical practice to include: 1) A complete medical history in relation to asthma 2) A comprehensive report of the clinical examination with specific focus on the respiratory system 3) A report of spirometry with the measure of the Forced Expiratory Volume in 1 second (FEV1) 4) If airway obstruction is present, the spirometry will be repeated after inhalation of a short acting beta-2 agonist to demonstrate the reversibility of bronchoconstriction 5) In the absence of reversible airway obstruction, a bronchial provocation test is required to establish the presence of airway hyperresponsiveness 6) Exact name, speciality, address (including telephone, e-mail, fax) of examining physician.
314
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5
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Permitted
Prohibited
Prohibited in men
Prohibited in competition
Prohibited in specific sports
Restricted b2 agonists
Declaration required
NEOPLASTIC
DISORDERS
regimen. EGFR-expressing, KRAS wild-type metastatic colorectal cancer in combination with cetuximab if no prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy. 1st-line treatment of metastatic carcinoma of the colon or rectum in combination with 5-fluorouracil, folinic acid and bevacizumab. 1st- line treatment of metastatic colorectal carcinoma in combination with capecitabine with or without bevacizumab. P Monotherapy: 350mg/m2 as an IV inf. over 30-90 mins. every three weeks or 125mg/m2 as an IV inf. over 90 mins. for 4 consecutive weeks followed by a 2 week rest. The weekly regimen is suitable for patients who need closer follow up or who are at particular risk of severe neutropenia. Combination therapy: 180mg/m2 every 2 weeks by IV inf. over 30-90 mins. followed by inf. with folinic acid and 5-fluorouracil. Other combinaisons, see SPC. Q Not recommended. D Chronic IBD, bowel obstruction, bilirubin q 3 x ULN, severe bone marrow failure, WHO performance status q 2, impaired renal failure. Pregnancy (up to 3 months after therapy), lactation. 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 CYP3A4 inhibitors/ inducers. Drugs with cancer, where there is increased cardiac risk. AIDSanticholinesterase activity (caution). related Kaposi’s sarcoma. Advanced ovarian cancer A Delayed diarrhoea, nausea, vomiting, in women who have failed 1st-line platinum-based constipation, neutropenia, anaemia, chemotherapy. In combination with bortezomib thrombocyctopenia, dyspnoea, muscular for progressive multiple myeloma in patients with 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 Taxane. Paclitaxel 6mg/ml. Clear colourless or Myeloma: 30mg/m2 on day 4 of the bortezomib 3 slightly yellow viscous soln for inf. in vial. 5ml, week regimen as a 1 hour inf. See SPC. A18.85; 16.7ml, A61.10; 25ml, A88.95; 50ml, Q Under 18 years, not recommended. A177.89. D Not be used to treat AIDS-KS that may S Ovarian cancer: 1st line treatment of be treated effectively with local therapy or advanced ovarian cancer or with residual disease systemic a-interferon. Avoid pregnancy up to 6 (q1cm), in combination with cisplatin. 2nd line months after discontinuation. Lactation. treatment of metastatic ovarian cancer where B Frequent ECG monitoring necessary. platinum therapy has failed. Breast cancer: Impaired cardiac function (caution). Adjuvant treatment of node-positive breast Myelosuppression, sometimes life-threatening inf. carcinoma following anthracycline and reactions (discontinue immediately). Contains cyclophosphamide (AC) therapy (as alternative to sucrose. extended AC therapy). Initial treatment of locally C Caution: Anthracyclines, cytotoxic advanced or metastatic breast cancer in agents, especially myelotoxic. combination with either anthracycline or A Palmar-plantar erythrodysesthesia, trastuzumab (in patients over-expressing HER2 at a stomatitis/mucositis, nausea, alopecia, rash, 3+ level when anthracycline is not suitable). As fatigue. Upper respiratory tract infection, single agent, metastatic breast cancer where leukopaenia, anaemia, paresthesia, anorexia, GI anthracycline has failed or is not suitable. disorders. See SPC. Advanced non-small cell lung carcinoma (NSCLC): In combination with cisplatin where surgery and/ CAMPTO Pfizer or radiation therapy not suitable. AIDS-related 2JN Kaposi’s sarcoma (KS) where liposomal Topoisomerase 1 inhibitor. Irinotecan (HCl anthracycline therapy has failed. P By IV infusion, repeated every 3 weeks trihydrate) 20mg/ml. Soln. in vials. 1 x 2ml; 1 x (except for KS). Ovarian cancer, 1st line: 175mg/ 5ml; 1 x 15ml. Prices on request. m2over 3 hrs followed by cisplatin 75mg/m2, or S Advanced colorectal cancer, in combination with 5-fluorouracil and folinic acid in 135mg/m2 over 24 hrs followed by cisplatin 75mg/ m2. Ovarian and breast cancer, 2nd line: 175mg/m2 patients without prior chemotherapy; over 3 hrs. Breast cancer, adjuvant: 175mg/m2 over monotherapy in patients who have failed an 3 hrs, for 4 courses following AC therapy. Breast established 5-fluorouracil containing treatment
day over 2 days initiated for a least 24 hours following the 16th dose of Busilvex. Obese patients: Use adjusted ideal BW (see SPC). Q See SPC. D Pregnancy, lactation. B Profound myelosuppression; monitor frequent complete blood counts, including differential white blood cell and platelet. Prophylactic or empiric use of anti-infectives during neutropenic period. Caution: Renal impairment (monitor), hepatic impairement (if severe, monitor serum transaminase, alkaline phosphatase, bilirubin for one month), Fanconi anemia, history of mediastinal or pulmonary radiation, of seizures. Monitor cardiac function. Can impair fertility. Men advised not to father a child during and up to 6 months after and to seek advice on cryo-conservation of sperm prior to treatment. C Caution: Paracetamol, itraconazole. A Myelosuppression, depression, dizziness, anxiety, insomnia, anorexia, hyperglycaemia, serum electrolyte disorders, GI / cardiac / respiratory / renal and urinary disorders, cough, rash, alopecia, back pain, myalgia, arthralgia, fever, pain, headache, allergic reaction, oedema general, weight increase, hepatomegaly, jaundice.
NEOPLASTIC DISORDERS 20.1 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 carcinoma of the lung. D Severe myelosuppression, pre-existing severe renal impairment, history of severe allergies to carboplatin, other platinum containing compounds or mannitol.
CARDIOXANE
Novartis
2J EDTA analogue. Dexrazoxane 500mg (as HCl salt). Lyophilized powder for soln for inf. in vial. 1, A217.09. S Prevention of cardiotoxicity in cancer patients receiving anthracycline-containing chemotherapy. P Admin. by short IV inf. over 15 min, approx. 30 min prior to each anthracycline admin., leaving 15 min between treatments. Use 20 x doxorubicin dose and 10 x epirubicin dose. Q Not recommended. D Risk of pregnancy, lactation. B Monitor haematology regularly, particularly during 1st two cycles. Liver impairment (monitor liver function), renal impairment. A Leukopenia, thrombocytopenia, inj. site reactions.
CASODEX
AstraZeneca
2NT Anti-androgen. Bicalutamide 50mg. White film-ctd tab. marked CDX50 and logo. 28, A129.94.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
315
20.1 NEOPLASTIC
S Advanced prostate cancer in combination with LHRH analogue therapy or surgical castration. P 1 daily commencing on day of initiation of LHRH analogue therapy or concomitantly with surgical castration. Q Contraindicated. D Women, children. B Moderate to severe hepatic impairment. Consider periodic liver function tests. Discontinue if severe hepatic changes or hepatic failure occur. Reduction in glucose tolerance may occur; consider monitoring blood glucose. Contains lactose. C Contra: Terfenadine, astemizole, cisapride. Caution: Ciclosporin, Ca++ channel blockers, other drugs which may inhibit drug oxidation (e.g. cimetidine, ketoconazole), coumarin anticoagulants. A Anaemia, anorexia, decreased libido, dizziness, somnolence, hot flush, GI disorders, dyspepsia, flatulence, hepatic changes/ hepatobiliary disorders, skin disorders, haematuria, gynaecomastia, breast tenderness, impotence, asthenia, chest pain, oedema, weight gain.
CASOMIDE
Clonmel
2NT Anti-androgen. Bicalutamide 50mg. White round biconvex film-ctd tab. 28, A38.25. S Advanced prostate cancer: In combination with LHRH analogue therapy or surgical castration. Locally advanced prostate cancer: Alone or as adjuvant therapy to radical prostactectomy or radiotherapy in patients at high risk for disease progression. P Advanced prostate cancer: 50mg, once daily. Start treatment at least 3 days before treatment with LHRH analogue or same time as surgical castration. Locally advanced prostate cancer: 150mg once daily continuously for at least 2 years or until disease progression. D Females and children. History of hepatic toxicity with bicalutamide. 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. C Contra: Terfenadine, astemizole, cisapride. Caution: Ciclosporin, Ca++ channel blockers, medicinal products that inhibit the oxidation process in the liver (e.g. cimetidine, ketoconazole), coumarin anticoagulants. A Breast tenderness, gynaecomastia, GI disorders, hepatic changes, hot flushes, asthenia, pruritus, dry skin, rash, maculopapular rash, sweating, hirsutism, alopecia, diabetes mellitus, weight gain, anaemia, dizziness, somnolence, oedema, general/pelvic pain, chills, decreased libido, erectile dysfunction, impotence.
CERUBIDIN
sanofi-aventis
2N Anthracycline. Daunorubicin (HCl) 20mg. Powder in vial. 1, A44.80. S Remission in acute lymphatic and myelogenous leukaemia. V Under 2 years or Q 0.5 m2 body surface area, 1mg/kg/day; over 2 years, 40-60mg/m2 on alternate days for a course of up to 3 inj. Acute myelogenous leukaemia and acute lymphatic leukaemia, 45mg/m2 daily.
316
NEOPLASTIC DISORDERS
DISORDERS D Non-malignant disease, acute infections, marked bone marrow suppression, oropharyngeal ulceration, chicken-pox, herpes zoster, intramuscular or subcutaneously. B Monitor blood counts, uric acid, cardiotoxicity. Reduce by 25% if bilirubin 1.2-3mg/ 100ml and by 50% if bilirubin q3mg/100ml. A Leucopenia, thrombocytopenia, GI disturbances, headache, allergic reactions, fever, weakness, alopecia, stomatitis, rash. Urine may be temporarily coloured red.
CISPLATIN
Hospira
2NO Alkylating cytotoxic. Cisplatin 10mg, 50mg, 100mg. Soln. in vials. 10mg-1, A15.05; 50mg-1, A22.47; 100mg-1, A34.79. S Management of neoplastic disease, metastic testicular tumours, refractory ovarian carcinoma, bladder carcinoma, squamous cell carcinoma of head and neck. V See lit. D Renal impairment, hearing impairment, myelosuppression. Pregnancy, lactation.
CYTARABINE
Hospira
2NO Nucleoside analogue. Cytarabine 100mg/ml, 100mg/5ml, 1g/10ml. 100mg/1ml-5, A74.12; 100mg/5ml-5, A74.71; 1g/10ml-1, A32.70.
DAUNOXOME
Gilead
2N Anthracycline. Daunorubicin (HCl) in liposomes 50mg (2mg/ml). Emuls. in vial. 1, A226.00. S AIDS-related Kaposiâ&#x20AC;&#x2122;s sarcoma in patients with low CD4 cell counts (Q200cells/mm3) and extensive mucocutaneous or visceral disease. P 0,2mg-1mg/ml of soln. diluted with 5% dextrose admin. IV over 30-60 mins. Initially, 40 mg/m2 every two weeks. D Pregnancy, lactation. B Risk of myelosuppression (monitor bone marrow function). Frequent ECG monitoring. 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
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. C Avoid: Hepatotoxic drugs, excessive alcohol consumption. Anticoagulants, steroids, theophylline. A Increased appetite, insomnia, diarrhea, nausea, vomiting, gynecomastia and/or breast tenderness, galactorrhea, tiredness, transient abnormal liver function and hepatitis.
EFUDIX
Meda
2NO Nucleoside analogue. Fluorouracil 5%. Cream. 20g, A19.26; 40g, A38.52. S Superficial pre-malignant and malignant skin lesions. Keratoses, Bowenâ&#x20AC;&#x2122;s disease, superficial basal-cell carcinoma. P Apply thinly once or twice daily to lesion. Duration: Usually 3-4 weeks. Q Not recommended. D Pregnancy, lactaction. 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
Astellas
6NT
6MT
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.
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
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.
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
NEOPLASTIC
DISORDERS
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 Q Not applicable. ALSO ENDOXANA TABLETS Cyclophosphamide D Pre-existing endometrial hyperplasia, 50mg. White, round, bi-convex sug-ctd tab. 100, A9.21. severe hepatic failure, QT prolongation, electrolyte disturbances (eg. hypokalaemia), bradycardia, P See SPC. 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: C Sulphonylurea drugs, marrow Thiazide diuretics, enzyme inducers (eg. depressant drugs, allopurinol, suxamethonium, phenobarbital, phenytoin and carbamazepine), concurrent radiotherapy or cytotoxic agents. CYP3A4 inhibitors (see annexe). A Anorexia, nausea and vomiting and A Hot flushes, depression, sweating, rash, mucosal ulceration, alopecia, acute sterile nausea, vomiting, leukorrhoea, dizziness, oedema, haemorrhagic cystitis. uterine bleeding, fatigue.
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.
NEOPLASTIC DISORDERS 20.1 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: 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 ERBITUX Merck Serono FASLODEX AstraZeneca class III (amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, cisapride, 2JN 5NT moxifloxacine, antipsychotics. Monoclonal antibody. Cetuximab 2mg/ml, 5mg/ml. Anti-oestrogen. Fulvestrant 250mg. 5ml soln. in A Hot flush, inj. site adverse events. Sln for inf. 2mg/ml-50ml vial; 5mg/ml-20ml and pre-filled syringe. A507.88. 100ml vials. Price on request. S Postmenopausal women with oestrogen Anaemia, weight increase, insomnia, dizziness, headache, diarrhoea, nausea, increased liver receptor positive, locally advanced or metastatic S Treatment of epidermal growth factor transaminases, hyperhidrosis, rash, musculoskeletal breast cancer for disease relapse on or after receptor (EGFR)-expressing, KRAS wild-type pain, gynaecomastia, testicular atrophy, ED, chills, adjuvant antioestrogen therapy or disease metastatic colorectal cancer, in combination with pyrexia, fatigue, flu-like illness. progression on therapy with an antioestrogen. chemotherapy or as single agent in patients who P 250mg at intervals of 1 month by IM have failed oxaliplatin- and irinotecan-based FLUDARA ORAL Genzyme inj. slowly into buttock. therapy and who are intolerant to irinotecan. 2NT Q Children or adolescents, not Treatment of locally advanced squamous cell Nucleoside analogue. Fludarabine (phos.) 10mg. recommended. cancer of the head and neck (SCCHN) in Salmon-pink film-ctd cap.-shaped tab. marked D Severe hepatic impairment. Pregnancy, combination with radiation therapy. with LN in a hexagon one side. 15; 20. Prices P Initially, 400mg/m2 body surface area by lactation. available on request. IV inf. over 120 mins. Then 250mg/m2 once a week B Mild to moderate hepatic impairment. by 60 min inf. Max infusion rate:10mg/min. Severe renal impairment (cc Q30ml/min). Bleeding S B-cell chronic lymphocytic leukaemia Premedicate with antihistamine and corticosteroid diatheses, thrombocytopenia or patients taking (CLL) with sufficient bone marrow reserve and prior to 1st inf; also recommended for subsequent anticoagulant treatment. Risk of thromboembolic who have not responded to or whose disease has ones. Colorectal: Concomitant chemotherapy must events and osteoporosis. progressed during or after treatment with at least not be administered earlier than 1 hr after end of A Hot flushes, inj. site reactions. GI one standard alkylating agent containing regimen. cetuximab infusion, see relevant SPC for dosage. P 40mg/m2 body surface area given daily disturbance incl. nausea, vomiting, diarrhoea and AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
317
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
Limited data exists on the effect of dose increases from 400-600mg in patients progressing at the lower dose. (see SPC). ALSO FLUDARA IV Fludarabine (phos.) 50mg. Nucleoside analogue. Gemcitabine (HCl) equiv. Q Not applicable. Powder for soln. in vial. 5, A950.63. 200mg or 1g gemcitabine. 200mg and 1g vials D Lactation. S Initial treatment of B-cell chronic containing powder for soln. for infusion. Prices on B Hepatic impairment. Severe fluid lymphocytic leukaemia (CLL) or after first line request. retention. Weigh patients regularly. Regular therapy, in patients with sufficient bone marrow S In combination with cisplatin for locally monitoring of complete blood counts and liver reserve. advanced or metastatic bladder cancer. Locally function tests. Cardiac disease. Should not be used P 25mg/m2 body surface area given daily advanced or metastatic adenocarcinoma of the during pregnancy unless necessary. for 5 consecutive days every 28 days for 6 cycles. pancreas. In combination with cisplatin, as firstC CYP3A4 inhibitors, inducers or D Renal impairment, cc Q30ml/min. line treatment of locally advanced or metastatic substrates (see Appendix I), triazoloDecompensated haemolytic anaemia. Pregnancy, non-small cell lung cancer (NSCLC); monotherapy benzodiazepines, dihydropyridine, Ca++ channel lactation. can be considered in elderly patients or those with blockers, certain HMG-CoA reductase inhibitors B See SPC. performance status 2. Locally advanced or (i.e. statins), paracetamol, drugs being substrates of CYP2D6, warfarin. FLUOROURACIL Hospira metastatic epithelial ovarian carcinoma, in combination with carboplatin, in patients with A Headache, nausea, vomiting, diarrhoea, 2NO relapsed disease following a recurrence-free dyspepsia, abdominal pain, fatigue, myalgia, Nucleoside analogue. Fluorouracil 250mg/10ml; interval of at least 6 months after platinum-based, muscle spasm and cramps, musculo-skeletal pain, 500mg/20ml; 500mg/10ml; 2.5g/100ml; 2.5g/50ml. first-line therapy. In combination with paclitaxel, joint swelling, periorbital oedema, dermatitis, rash, Vials. 250mg/10ml-5, A41.18; 500mg/10ml-5, for unresectable, locally recurrent or metastatic fluid retention, neutropenia, thrombocytopenia, A63.67; 500mg/20ml-10, A65.88; 2.5g/100ml-1, breast cancer in patients who have relapsed anaemia. A18.08; 2.5g/50ml, A43.58. following adjuvant/neoadjuvant chemotherapy; S Alone or in combination for palliative prior chemotherapy should have included an GONAPEPTYL DEPOT Ferring action in managment of common malignancies anthracycline unless clinically contra-indicated. 6NT particularly cancer of colon/breast. P See SPC. Gn-RH analogue. Triptorelin (acetate) 3.75mg. V See lit. Q Not recommended. Powder and solvent for inj. prolonged release in D Non-malignant disease, patients D Pregnancy, lactation. pre-filled syringe. 1, A183.98. seriously debilitated or with bone marrow B Increased toxicity with prolongation of S Advanced, hormone-dependent prostate depression after radiotherapy or treatment with inf. time and increased dosing frequency. Bone carcinoma. other anti-neoplastic agents. Pregnancy, lactation. marrow function suppression may occur; monitor P One syringe (3.75mg) SC or deep IM inj. prior to each dose for platelet, leucocyte, and FOLINIC ACID Hospira every 28 days; change inj. site each time. granulocyte counts. Discontinue if serious 2NO pulmonary effects or microangiopathic haemolytic Q Not applicable. D Hormone independent prostate Folic acid derivative. Folinic acid (Ca++ folinate) anaemia occur. Radiotherapy (toxicity and carcinoma. Sole treatment in prostate cancer 3mg/ml, 15mg/2ml, 50mg/5ml, 100mg/10ml. Amps. radiation injury reported). May affect male fertility. Caution: History of cardiovascular events, patients with spinal cord compression or evidence and vials. Amps.: 3mg/ml x 5, A6.35; 15mg/2ml x of spinal metastases. After orchiectomy. hepatic insufficiency, impaired renal function. 5, A21.58; Vials: 50mg/5ml x 1, A19.05; 100mg/ B Premonitory signs of medullary Contains Na+. 10ml x 1, A37.97; 300mg/30ml x 1, A113.89. compression. Urinary tract obstructions. Monitor C Not recommended: Yellow fever and 2NO prostate-specific antigen (PSA) and testosterone other live attenuated vaccines. ALSO CALCIUM FOLINATE TABLETS Folinic acid A Myelosuppresssion (anaemia, leucopenia during treatment. Allergic and anaphylactic (Ca++ folinate) 15mg. Light yellow scored tab. reactions reported. and thrombocytopenia), anorexia, febrile marked cf one side. 10, A48.27. C Oestrogen. neutropenia. GI disorders, dyspnoea, cough, S Reduce/counteract toxicity of folic acid A Bone pain, libido decreased, hot flushes, antagonists eg. methotrexate (Calcium Leucovorin rhinitis, headache, somnolence, insomnia, rash, dysuria, impotence, headache, perspiration. alopecia, back pain, myalgia, flu-like symptoms, Rescue). Megaloblastic anaemias due to folate Hypersensitivity, depressive mood, irritability, oedema, fever, asthenia, chills, elevation of liver deficiency. nausea, myalgia, arthralgia, tiredness, sleep enzymes, mild proteinuria, haematuria. V Calcium Leucovorin Rescue: Initiate 24 disorders, inj. site pain/reaction, gynecomastia. hrs after beginning of methotrexate inf. Usually, GLIVEC Novartis 15mg (approx. 10mg/m2) every 6 hrs for 10 doses, GRANOCYTE Chugai 2NT either parenterally by IM inj., bolus IV inj. or IV 5NT Tyrosine kinase inhibitor. Imatinib (mesilate) inf., or orally using tabs. Do not administer 100mg, 400mg. Round tab. with ’NVR’ on one side Recombinant human granulocyte-colony intrathecally. Ensure prompt excretion of stimulating factor, rHu G-CSF. Lenograstim. methotrexate (see SPC). Folate Deficiency: Over 12 and scored on the other (100mg). Ovaloid, years, 10-20mg daily (usually 1 tab. daily); up to 12 biconvex tab. with bevelled edges, debossed ’NVR’ Powder in vial plus prefilled syringe with WFI. Granocyte-34: 33.6 MIU/vial. 5 x 1ml vial plus 5 x on one side and ’SL’ on the other (400mg). Both years, 0.25mg/kg/day. 1ml pre-filled syringe WFI or inf. Granocyte-13: D Treatment of pernicious anaemia/other film-ctd., very dark yellow to brownish-orange. 13.4 MIU/vial. 5 x 1ml vial plus 5 x 1ml pre-filled megaloblastic anaemia where vit. B12 is deficient. 100mg-60, A1384.87; 400mg-30, A2769.74. S Patients with Philadelphia chromosome syringe WFI or inf. Price available on request. B Lactation, pregnancy (only if benefit (bcr-abl) positive (Ph+) chronic myeloid leukaemia S Non-myeloid malignancy: reduction in outweighs risk). duration of neutropenia and associated C Do not admin. simultaneously with anti- (CML) for whom bone marrow transplantation is not considered as first line treatment. Patients complications following bone-marrow neoplastic folic acid antagonist (e.g. with Ph+ CML in chronic phase after failure of transplantation or following treatment with methotrexate). Phenobarbitone, phenytoin, interferon-alpha therapy, or in accelerated phase cytotoxic chemotherapy associated with significant primidone. or blast crisis. Patients with Kit (CD 117) positive incidence of febrile neutropenia. Granocyte may PRICES unresectable and/or metastatic malignant GI be admin. to patients with de novo acute myeloid The prices listed in MIMS Ireland stromal tumours (GIST). leukaemia aged above 55 years. Mobilisation of P CML: 400mg/day for chronic phase CML. peripheral blood progenitor cells (PBPCs). are trade prices and do not include 600mg/day for accelerated phase or blast crisis. P Cytotoxic-induced neutropenia: 150mcg/ pharmacist dispensing fees. They Dose increase to 600mg for chronic phase or m2/day (equiv. 5mcg/kg/day) by SC inj. started on are included as a guide to relative day after completion of chemotherapy, continue 800mg for accelerated phase or blast crisis if no cost and should not be regarded as haematological response is seen after 3 months, or until neutrophil count stable in acceptable range having any direct relationship with (max. 28 days). Bone marrow transplantation: if disease progresses. Take with food and a large 150mcg/m2/day (equiv. 5mcg/kg/day) by IV inf. glass of water. GIST: 400mg/day for patients with retail prices. started on day after completion of chemotherapy; unresectable and/or metastatic malignant GIST. for 5 consecutive days every 28 days for 6 cycles.
2N
318
GEMZAR
Lilly
2JN
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
or metastatic breast cancer in relapsed disease following adjuvant/ neoadjuvant chemotherapy including an anthracycline. Locally advanced or metastatic non-small cell lung cancer (in combination with other cytostatics or paliative treatment as single agent). Locally advanced or metastatic adenocarcinoma of the pancreas in patients with good general condition and adequate bone marrow reserves. P 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: Either gemcitabine 1250mg/m2 given by IV inf. over 30 min. on days 1 and 8 of each 21 day cycle or gemcitabine 1000mg/m2 by IV infusion over 30 min. on days 1,8,15 of each 28 day cycle. Cisplatin dose range: 75-100mg/m2 once every 3 or 4 weeks. 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. Bladder cancer: 1000mg/m2 by IV infusion over 30 min. on days 1,8,15 of each 28 day cycle and cisplatin 70mg/m2 on day 1 following gemcitabine on day 2. 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 HERCEPTIN Roche 1 and 8 of each 21 day cycle. Adjust dose according to blood counts (see SPC). 2N Q Not recommended. Monoclonal antibody. Trastuzumab 150mg. D Pregnancy, lactation. Powder for soln. for inf. in vial. 1 vial. Price on B Prolongation of inf. time, increased request. dosing frequency (increase toxicity). Compromised S Treatment of patients with metastatic bone marrow function. Monitor thrombocyte, breast cancer whose tumours overexpress HER2 leucocyte and granulocyte counts prior to each (see SPC). Treatment of HER2 positive early breast dose. Impaired hepatic/renal function (check cancer following surgery, chemotherapy periodically). Serious pulmonary effects, (neoadjuvant or adjuvant) and radiotherapy. microangiopathic haemolytic anaemia P Initial loading dose: 4mg/kg body (discontinue). weight followed by weekly dose of 2mg/kg body C Contra: Yellow fever vaccine. Caution: weight beginning one week after loading dose. Radiotherapy (risk of oesophagitis, pneumonitis, Doses should be administered as a 90-minute IV colitis), ciclosporin, tacrolimus. Avoid live inf. Observe patients for at least 6 hours after the attenuated vaccines and phenytoin. first inf. and for 2 hours after the start of A Myelosuppression, incl. leucopenia, subsequent inf. for symptoms (fever, chills, other thrombocytopenia, neutropenia. Anorexia, infusion-related symptoms). Interruption of inf. headache, somnolence, insomnia, GI disorders, may help control such symptoms, inf. may be dyspnoea, cough, rhinitis, rash, alopecia, sweating, resumed when symptoms abate. itching, myalgia, back pain, fever, asthenia, facial Q Under 18 years, not recommended. oedema. Elevation of liver enzymes, mild D Severe dyspnoea at rest due to proteinuria/ haematuria. complications of advanced malignancy or requiring supplementary oxygen therapy. HOSPIRA OXALIPLATIN Hospira Lactation. 2JN B Monitor for cardiotoxicity and inf. Alkylating agent. Oxaliplatin 5mg/ml. Soln: 10ml, reactions. Pulmonary events (dyspnoea, bronchospasm, asthma, hypoxia) can occur as part 20ml, 40ml. Powder: 50mg, 100mg - price on request. of inf. reaction. Pregnancy. S In combination with 5-fluorouracil (5A Fever, chills, abdominal pain, asthenia, FU) and folinic acid for: (a) adjuvant treatment of chest pain, headache, diarrhoea, nausea, vomiting, stage III (Duke’s C) colon cancer after complete anorexia, constipation, dyspepsia, dry mouth, resection of primary tumour; (b) metastatic arthralgia, myalgia, rash, allergic reaction, colorectal cancer. infection, pain, vasodilation, tachycardia, P 85mg/m2 as a 2-6 hour IV inf. in 250hypotension, heart failure, cardiomyopathy, 500ml of 5% glucose soln, repeated every 2 palpitation, leucopenia, peripheral oedema, leg weeks. Duration in adjuvant setting: 6 months (12 cramps, arthritis, anxiety, depression, dizziness, cycles). insomnia, asthma, cough, UTI. D Myelosuppression or peripheral sensitive neuropathy with functional impairment. Severe HOSPIRA GEMCITABINE Hospira renal impairment. Lactation, pregnancy 2JN (contraception recommended up to 4 months Nucleoside analogue. Gemcitabine (as HCl) 200mg, after therapy for women and 6 months for men). 1g, 2g. 200mg, 1g and 2g vials containing powder B Use only in specialised oncology for soln. for infusion. Prices available on request. departments. Moderate renal impairment. History of allergic reaction to platinum compounds. If S Locally advanced or metastatic bladder oxaliplatin extravasation occurs stop inf. Perform cancer in combination with cisplatin. In neurological examination before admin. and combination with paclitaxel, for locally advanced
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.
NEOPLASTIC DISORDERS 20.1 periodically thereafter. If acute laryngopharyngeal dysaesthesia develops with 2-hour inf., admin. next inf. over 6 hours. If neurological symptoms occur, adjust dose, see SPC. If haematological toxicity occurs postpone next course until normal levels return. Perform full blood count before each course. Reduce dose if grade 4 diarrhoea, grade 34 neutropenia or thrombocytopenia. A Infection, rhinitis, upper RTI, blood and lymphatic disorders, allergic reaction, anorexia, hyperglycaemia, hypokalaemia, hyponatremia, dehydration, depression, insomnia, peripheral sensory neuropathy, sensory disturbance, dysgeusia, headache, dizziness, motor neuritis, meningism, conjunctivitis, vision abnormal, haemorrhage, flushing, DVT, dyspnoea, coughing, epistaxis, pulmonary embolism, hiccups, GI disorders, skin and SC tissue disorders, alopecia, pain (chest/back/bone), arthralgia, dysuria, micturition disorder, haematuria, fatigue, fever, asthenia, pain, inj. site reaction.
HOSPIRA PACLITAXEL
Hospira
2N Taxane. Paclitaxel 6mg/ml. Soln. for infusion in vials. 30mg/5ml, A155.00; 100mg/16.7ml, A465.00; 150mg/25ml, A696.50; 300mg/50ml, A1393.00. S Advanced AIDS-related Kaposi’s sarcoma (KS) when liposomal anthracycline therapy has failed. Metastatic carcinoma of the breast (MBC) when standard anthracycline-containing therapy has failed or is inappropriate. Metastatic carcinoma of the ovary (MOC) after failure of platinum-containing combination therapy without taxanes. P KS: 100mg/m2 as 3-hour IV inf. every two weeks. MBC/MOC: 175mg/m2 as 3-hour IV inf. every three weeks. Adjustment during treatment, see SPC. Severe neutropenia, peripheral neuropathy or mucositis, reduce dose by 25%. Q Under 18 years, not recommended. D Severe hepatic impairment. Baseline neutropenia Q1000 cells/mm3 (KS) or Q1500 cells/ mm3 (MBC and MOC). Serious, uncontrolled infections. Pregnancy, lactation. B Perform frequent complete blood counts. Premedication with corticosteroid, antihistamine, and H2-receptor antagonist required (see SPC). Severe hypersensitivity reactions, discontinue. Cardiac conduction abnormalities and arrhythmias (monitor signs). Contains polyoxyl castor oil and ethanol. C Caution: Inhibitors or inducers of CYP3A4 and 2C8. A Bone marrow suppression. Hypersensitivity reaction. Vasodilatation, 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.
HYCAMTIN
GSK
2N Topoisomerase I inhibitor. Topotecan 4mg. Powder in vial. 1. Price on request. S Metastatic ovarian cancer where other therapies have failed. P 1.5mg/m2 daily by IV inf. over 30 mins. for 5 consecutive days. Repeat every 3 weeks. Q Not recommended.
2T
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
319
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
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.
with other myelosuppressive agents may require dose adjustments. 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 liver function (prior and during treatment), uric acid levels. Maintain a high fluid intake. Driving/ operating machinery. C Previous or concomitant radiotherapy or cytotoxic therapy may potentiate activity. Antiretroviral agents (e.g. didanosine, stavudine, indinavir). A Bone-marrow suppression, leucopenia, thrombocytopenia, anaemia.
frequency, reproductive/breast disorders, chest pain, hepatomegaly, blood/lymphatic disorders, tinnitus, vertigo, palpitation, tachycardia, hypertension, weight decrease. See SPC.
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
LEUKERAN
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). A 10 MIU/ml-1 x 2.5ml, 190.23. 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 HYDREA BMS chronic myeloid leukaemia, multiple myeloma, follicular lymphoma, carcinoid tumours, malignant Guanine analogue. Thioguanine 40mg. Pale green2NO yellow circular tab. marked WELLCOME U3B on DNA reactive cytotoxic. Hydroxycarbamide 500mg. melanoma. one side and a score line on the other. 25, V See SPC. Green/pink cap. marked BMS 303. 100, A13.91. A43.24. D History of severe pre-existing cardiac S Malignant neoplastic disease incl. disease. Severe renal/hepatic dysfunction. Epilepsy, S Acute myeloblastic leukaemia and acute chronic myeloid leukaemia. Cancer of the cervix lymphoblastic leukaemia. Also used in the compromised CNS. Chronic hepatitis with and other solid type tumours in conjunction with treatment of chronic granulocytic leukaemia. decompensated cirrhosis or in patients being or radiotherapy. V 60-200mg/m2 body surface area per day. have been treated recently with P Start 7 days before irradiation therapy. D Non-malignant disease. Pregnancy, immunosuppressives excluding short term Evaluate antineoplastic effect after 6 weeks. corticosteroid withdrawal. Autoimmune hepatitis; lactation. Significant response: Continue indefinitely under B Not recommended for maintenance or or history of autoimmune disease; observation. Interrupt if WBCs (WBC)Q 2.5x109/L long term therapy. Regularly monitor blood cell immunosuppressed transplant recipients. or platelet count Q 100x109/L. Continuous counts and liver function tests. Myelosuppressant: (suitable for chronic myeloid leukaemia): 20-30mg/ Uncontrolled pre-existing thyroid disease. Severe Monitor during therapy. Lesch-Nyhan syndrome; psychiatric conditions (or history of) in children. kg daily in single doses. Based on actual or ideal monitor for resistance. Pregnancy, lactation. weight, whichever less. Intermittent (solid type C Not recommended: Live organism tumours): 80mg/kg in single doses every third day. B Caution: History of pulmonary disease, vaccinations. Allopurinol. Caution: diabetes prone to ketoacidosis, coagulation If low WBC produced, omit 1 or more doses. Use 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.
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.
320
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
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
6-12mg daily until leucopenia occurs, followed by 2-8mg daily indefinitely. 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.
Price available on request. Q Not applicable. S Combination with cyclophosphamide, D Pregnancy, lactation. first-line treatment of metastatic cancer in women. B Thrombophlebitis. A Weight gain, nausea, vomiting, oedema, NAVELBINE ORAL Pierre Fabre breakthrough uterine bleeding, urticaria.
METHOTREXATE 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 weeks. Initial rate: 50mg/hr for 30 mins. increasing D Bone marrow aplasia, myelosuppression, urinary tract obstruction, acute infections incl. to max 400mg/hr as tolerated. Subsequent infusions: 100mg/hr for 30 mins. increasing to max. UTIs, urothelial toxicity, renal/hepatic impairment, 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.
2NT
Goldshield 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-Hodgkin’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
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
321
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
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, 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 NEXAVAR Bayer Schering count and haematocrit. Needle cover contains dry 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. Johnâ&#x20AC;&#x2122;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 causes of anaemia; iron suppl. may be necessary. Monitor Hb, BP, platelet count, serum electrolytes. 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.
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
322
Q Not recommended. D Pregnancy, lactation. 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-Hodgkinâ&#x20AC;&#x2122;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. A7.23. Haematuria, UTIs, inflammation of bladder. Pregnancy, lactation (only if essential). S Breast cancer. P 20-40mg daily; as single dose or divided B Special attention at high doses. Monitor haematological function freq. Assess cardiac in 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
NEOPLASTIC
DISORDERS
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 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. 6 P SC inj: 18x10 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 2NO days, followed by 2-6 days without active 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 Q Not applicable. organ dysfunction, CNS metastases (unless treated 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, Nucleoside analogue. Mercaptopurine 50mg. Fawn nephrotoxic, myelotoxic, or cardiotoxic effects, scored tab. coded GX above score and EX2 below CNS acting drugs, antihypertensives, antineoplastic score. 25, A17.88. agents, cis-platinum, vinblastine, dacarbazine, S Acute leukaemia. Maintenance therapy interferon-alfa. in: Acute lymphoblastic leukaemia, acute A Fever, headache, pain, weight change, myelogenous leukaemia, chronic granulocytic GI disorders, dyspnoea, cough, hypotension, chest leukaemia. pain incl. angina pectoris, hypertension, R Reduce dose in renal and hepatic tachycardia, dizziness. Mental status changes eg. impairment. See SPC. irritability, confusion, depression. Inj. site reaction, V Usual dose: 2.5mg/kg/day or 50-75mg/m2 skin exfoliation, pruritus. Arthralgia, oedema, body surface area per day depending on dose of dehydration, myalgia, hypothermia. Elevated other cytotoxic drugs given with puri-nethol. A hepatic enzymes and serum urea/creatinine, quarter of the usual dose given if co-admin. with oliguria, anaemia, thrombocytopenia, leukopenia, allopurinol. hyperglycaemia. D Acute untreated infections. Pregnancy, PROSTAP SR Takeda lactation. B Mylosuppressant: Monitor during and 6NT after therapy. Full blood counts must be taken LHRH analogue. Leuprorelin acetate 3.75mg. during remission induction. Monitor liver function Powder and 1ml solvent for prolonged-release weekly. Dose reduction in renal transplant suspension for inj. 1, A163.01. patients. Monitor uric acid levels. Mutagenicity S Management of prostatic carcinoma and carcinogenicity reported rarely. when testosterone suppression is indicated. C Not recommended: Live organism P 3.75mg admin. by SC or IM inj. once vaccinations. Allopurinol, warfarin. Caution: monthly. Aminosalicylates. 6NT A Bone marrow suppression, leucopenia, ALSO PROSTAP 3 Leuprorelin (acetate) 11.25mg. thrombocytopenia. GI disturbances, pancreatitis, function before therapy. Check liver function tests regularly. Local pain and swelling may occur at inj. 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.
NEOPLASTIC DISORDERS 20.1 biliary stasis, hepatotoxicity.
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 patient’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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
323
20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
neutrophil counts. Renal impairment: See SPC. 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 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.
324
by SC inj. Depending on response, increase to 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
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
whole. Accelerated, myeloid or lymphoid blast 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.
metastatic renal cell carcinoma (MRCC). 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.
CYP1B1 substrates and modulators, UGT1A1 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 ’Targretin’. 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. Avoid donating blood. SUPREFACT DEPOT sanofi-aventis Anti-oestrogen. Tamoxifen (citrate) 10mg, 20mg. 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. A Implant (2 controlled release rods). 1, 295.77. 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 A (acetate) 100mcg/dose. 4 x 100 dose unit, 136.33. 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 A 50mg, caramel. 12.5mg-28, 1222.06; 25mg-28, persistent diarrhoea/vomiting (interrupt therapy for first 2 months; then monthly or as indicated. A2444.12; 50mg-28, A4888.24. 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 AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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20.1 NEOPLASTIC
NEOPLASTIC DISORDERS
DISORDERS
pancreatitis, relevant cardiac disorders. Contains 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.
Immunosuppressive agent. Thalidomide 50mg. White opaque hard cap. marked Thalidomide 50mg Pharmion. 28, A336. Alkylating agent. Temozolomide 5mg, 20mg, S In combination with melphalan and 100mg, 250mg. White/coloured caps. marked in prednisone as 1st-line treatment of patients with black ink with Temodal on cap and strength, the untreated multiple myeloma, aged r 65 years or Schering-Plough logo and two stripes on the ineligible for high dose chemotherapy. Prescribe body. 5mg-5, A25.76; 20mg-5, A103.05; 100mg-5, and dispense according to the Thalidomide A515.26; 250mg-5, A1288.17. Pharmion Pregnancy Prevention Programme (see S Newly diagnosed glioblastoma SPC). multiforme concomitantly with radiotherapy (RT) P 200mg/day in single dose at bedtime. and subsequently as monotherapy. Malignant Max duration: 12 cycles of 6 weeks. glioma, such as glioblastoma multiforme or Antithrombotic prophylaxis recommended for anaplastic astrocytoma, showing recurrence or patients at risk of thromboembolic events. progression after standard therapy. Peripheral neuropathy: See SPC for dose P Swallow caps. whole with water in adjustment. 2 fasting state. Concomitant phase: 75mg/m daily Q Not recommended. for 42 days with focal RT, see SPC. Monotherapy D Pregnant women, women of phase: Start 4 weeks after completing concomitant childbearing potential unless all conditions of the phase and admin. for up to 6 cycles. Cycle 1: Thalidomide Pharmion Pregnancy Prevention 150mg/m2 once daily for 5 days + 23 days without Programme are met, patients unable to follow or treatment. Cycle 2, increase to 200mg/m2 according comply with required contraceptive measures. to toxicity, see SPC. Once escalated, dose remains Lactation. at 200mg/m2 per day for 1st 5 days of each B Powerful teratogen, all patients must subsequent cycle except if toxicity occurs. If dose fulfil the conditions of the Thalidomide Pharmion not increased at Cycle 2, do not increase in Pregancy Prevention Programme, see SPC. subsequent cycles. Dose reductions and Increased risk of DVT and pulmonary embolus. discontinuations during the monotherapy phase, Monitor for symptoms of peripheral neuropathy, see SPC. Recurrent or progressive malignant syncope and bradycardia. Discontinue if toxic skin TAXOTERE sanofi-aventis glioma: Treatment cycle: 28 days. Patients reactions (e.g. Stevens-Johnson syndrome) occur. 2JN previously untreated with chemotherapy, 200mg/ Caution: Renal or hepatic impairment. Driving/ Taxane. Docetaxel 20mg, 80mg. Concentrate and m2 once daily for 5 days + 23 day treatment operating machines. Contains lactose. solvent for soln, for inf. Price available on request. interruption. Patients previously treated with C Not recommended: Combined hormonal S Locally advanced or metastatic breast chemotherapy, initially 150mg/m2 once daily, contraceptives. Caution: Anxiolytics, hypnotics, cancer in combination with doxorubicin for increased in the second cycle to 200mg/m2 once antipsychotics, H1 anti-histamines, opiate daily, for 5 days if there is no haematological patients who have not previously received derivatives, barbiturates, alcohol, drugs inducing toxicity. cytotoxic therapy for this condition. Locally torsade de pointes, beta blockers, advanced or metastatic breast cancer after failure Q Recurrent or progressive malignant anticholinesterase agents, vincristine, bortezomib, of cytotoxic therapy, which should have contained glioma: Patients 3 years of age or older, as per warfarin (with prednisone). adults. an anthracycline or alkylating agent. Locally A Cardiac failure, bradycardia, D Hypersensitivity to dacarbazine. Severe advanced or metastatic breast cancer in neutropenia, leukopenia, anaemia, lymphopenia, myelosuppression. Pregnancy, lactation. combination with capecitabine after failure of thrombocytopenia, peripheral neuropathy, tremor, anthracycline-containing cytotoxic therapy. Locally B Monitor for Pneumocystis carinii dizziness, paraesthesia, dysaesthesia, somnolence, advanced or metastatic non-small cell lung cancer pneumonia (PCP); concomitant regimen: abnormal coordination, pulmonary embolism, Prophylaxis against PCP required. Anti-emetic (NSCLC) in combination with cisplatin in patients interstitial lung disease, bronchopneumopathy, therapy may be required, see SPC. Prior to dosing who have not previously received chemotherapy dyspnea, GI disturbances, toxic skin eruption, rash, the following must be met: ANCr1.5x109/l and for this condition. Locally advanced or metastatic dry skin, pneumonia, deep vein thrombosis, platelet count r100x109/l. A complete blood NSCLC after failure of prior chemotherapy. peripheral oedema, pyrexia, asthenia, malaise, count should be obtained on Day 22 and weekly Hormone refractory metastatic prostate cancer in confusional state, depression. until ANC q1.5x109/l and platelet count q100x109/ combination with prednisone or prednisolone. 9 P Admin as a 1-hour IV inf. every 3 weeks. l. If ANC falls Q1.0x10 /l or platelet count is TOMUDEX AstraZeneca Q50x109/l during any cycle, the next cycle should Breast cancer monotherapy: 100mg/m2. Breast 2NO be reduced one dose level. Caution: Elderly. Men cancer in combination, NSCLC mono or Folate analogue. Raltitrexed 2mg. Powder in vial. should not father a child during and up to 6 combination, or prostate cancer in combination: 1 x 5ml. Price available on request months after treatment. Contains lactose. 75mg/m2. S Treatment of advanced colorectal cancer C Valproic acid. Q Not recommended. P 3mg/m2 as a 15 min. IV inf. Repeat if A Both: Infection, oral candidiasis, D Previous severe hypersensitivity to necessary at 3 week intervals. See SPC. thrombocytopenia, leukopenia, anorexia, weight docetaxel or excipients. Baseline neutrophils Q Not recommended. decreased, anxiety, emotional lability, insomnia, Q1500 cells/mm3 . Severe liver impairment. D Severe renal impairment. Pregnancy, nervous system disorders, hearing impaired, eye Pregnancy, lactation. disorders, haemorrhage, dyspnoea, coughing, GI lactation. B Pretreat with oral corticosteroid to disorders, skin and SC tissue disorders, muscle B Monitor patients for toxic effects during reduce incidence of fluid retention (see SPC). weakness, arthralgia, urinary incontinence, treatment. Depressed bone marrow function, prior Monitor blood counts. Monitor patients during fatigue, oedema leg, allergic reaction, fever, to radiotherapy. Elderly. Conception should be inf. for hypersensitivity reactions. Patients with radiation injury, pain, taste perversion, ALT avoided during and for at least 6 months after liver impairment require liver function tests. increased. TMZ + concomitant RT only: Herpes cessation. Ability to drive or operate machinery Contraception required during and for 3 months simplex, wound infection, pharyngitis, may be impaired. after therapy. neutropenia, lyphopenia, hyperglycaemia, C Folinic acid, folic acid, vitamins. C Caution: Cyclosporin, ketoconazole, oedema, erythema, micturition frequency, face A Nausea, vomiting, diarrhoea, anorexia, erythromycin, troleandomycin, terfenadine. oedema. TMZ monotherapy only: Febril leucopenia, anaemia, thrombocytopenia, athralgia, A Neutropenia, febrile neutropenia, neutropenia, anaemia, depression, tinnitus, DVT, hypertonia, rash, pruritus, asthenia, fever. thrombocytopenia, anaemia, hypersensitivity musculoskeletal pain, myalgia. reactions, cutaneous reactions, fluid retention, TORISEL Wyeth nausea, vomiting, diarrhoea, stomatitis, peripheral THALIDOMIDE PHARMION Celgene 2 J neuropathy, increase in liver enzymes, alopecia, 2T mTOR inhibitor. Temsirolimus 25mg/ml (10mg/ml myalgia, mucositis.
326
TEMODAL
Schering-Plough
2NT
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 hyperglycaemia, hypokalaemia, paraesthesia, pleuritic pain, dyspnoea, bone pain, arthralgia, pyrexia, fatigue, ECG QT prolonged, ALT/AST increased.
expressing metastatic colorectal carcinoma with 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 treatment of advanced or metastatic breast cancer fibrosis. Pregnancy (use contraception during 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 treatment and 8 weeks after treatment. Contains that could impair LV function. Evaluate LVEF in all + 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 failure, elderly. Monitor electrolyte and glycaemia patients treated with ifosfamide or 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 when diluted). Clear, colourless to light-yellow 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.
AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
327
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DISORDERS
diffuse infiltrative pulmonary and pericardial 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.
2JN
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.
VEPESID 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 R No specific dose adjustments days. 21 day interval and satisfactory blood picture recommended, monitor renal function. (i.e. no evidence of myelosupression) between Q Below 18 years, not recommended. courses. Avoid extravasation. Do not give as intra- D 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
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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
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
therapy which should have included an 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.
C Contra: Yellow fever vaccine. Avoid: 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.
B Bone marrow depletion. Not 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 applicator. 1(month course), A159.50. ZAVEDOS Pharmacia S Prostate cancer suitable for hormone 2NT manipulation. Breast cancer in pre- and perimenopausal women suitable for hormone Anthracycline. Idarubicin 5mg, 10mg. Orange-red 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 abdominal wall every 28 days. S Remission induction of acute nonlymphocytic 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/ Q Not applicable. YONDELIS Pharma Mar m2/day x 3 days. Monitor haematological status D Pregnancy, lactation. 2J prior to admin. B Male patients at risk from ureteric 2 T Alkylating agent. Trabectedin 0.25mg, 1mg. White obstruction or spinal cord compression; monitor ALSO ZAVEDOS CAPS Idarubicin 5mg, 10mg. Red for 4 weeks. Transient exacerbation of condition to off-white powder for conc for soln for inf. in which can be prevented by prophylactic use of cap. and white body marked IDARUBICIN 5 and vial. 0.25mg-1, A530; 1mg-1, A1994. antiandrogens. IDARUBICIN 10 resp. 5mg-1, A38.03; 10mg-1, S Advanced soft tissue sarcoma, where A A Hot flushes, decreased libido, breast 76.08. anthracyclines and ifosfamide are inappropriate. In swelling and tenderness, rashes. Also in females, combination with pegylated liposomal doxorubicin S Remission induction of AML in elderly headache, emotioal lability, vaginal dryness, untreated patients when IV treatment cannot be (PLD) in relapsed platinum-sensitive ovarian hypercalcaemia. employed. cancer. 2 2 P 30mg/m orally for 3 days daily as a P 1.5mg/m body surface area, admin. as 2 ZOMETA Novartis single agent or between 15-30mg/m orally for 3 IV infusion over 24 hrs with a 3-week interval 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, Concentrate for sln for infusion. Price available on severe liver or renal impairment, uncontrolled Q Not recommended. request. infection or patients hypersensitive to D Concurrent serious or uncontrolled S Prevention of skeletal related events anthracyclins. Pregnancy, lactation. infection. Pregnancy (unless clearly necessary); (pathological fractures, spinal compression, B Care during prep. and admin. Assess contraception for men and women up to 3 radiation or surgery to bone, or tumour-induced haematological profiles before/during therapy. months after treatment). Lactation (up to 3 hypercalcaemia) in patients with advanced Monitor cardiac and renal/liver function. May months after treatment). malignancies involving bone. Treatment of B Criteria required prior to treatment and colour urine red for 1-2 days after admin. tumour-induced hypercalcaemia (TIH). A Nausea, vomiting, mucositis, reversible re-treatment: ANCr1500/mm3, platelet count P 4mg/5ml reconstituted and diluted with alopecia, myelosuppression, cardiac toxicity, 3 r100,000/mm , bilirubin RULN, alkaline 100ml infusion solution and given as a single 15diarrhoea, raised liver function tests. phosphatase (AP)R2.5xULN, albumin r25g/l, ALT min. IV inf. Q Not applicable. and ASTR2.5xULN, cc r30ml/min, CPKR2.5xULN, Bayer Schering D Severe renal impairment. Pregnancy, hbr9g/dl. Weekly monitor bilirubin, AP, ALT, AST ZEVALIN 2JN lactation. and CPK during cycles 1 and 2 and at least once Murine monoclonal antibody. Ibritumomab B Monitor hypercalcaemia-related between treatments in further cycles. Clinically metabolic parameters and renal function. relevant liver disease: Closely monitor; adjust dose tiuxetan 1.6mg/ml. Kit for radiopharmaceutical preparation for inf. Price available on request. Maintain patients well hydrated prior to and if needed. Neutropenia and thrombocytopenia following admin. Avoid over-hydration in patients may occur: Full blood cell count weekly in cycles 1 S Adults with rituximab relapsed or at risk of cardiac failure. Caution in patients with refractory CD20+ follicular B-cell non-Hodgkin’s and 2 and once between further cycles. Patients severe hepatic insufficiency. lymphoma (NHL). developing fever should promptly seek medical P Platelets counts r150,000/mm3: 15MBq C Caution when administering with attention, start active supportive therapy aminoglycosides, nephrotoxic drugs, thalidomide. immediately. Rhabdomyolysis may occur; establish per kg body weight. Platelets counts Q150,000 A Anaemia, headache, nausea, vomiting, and q100,000/mm3: 11MBq per kg body weight. parenteral hydration, urine alkalinisation and anorexia, bone pain, myalgia, arthralgia, renal Max: 1200MBq. See SPC. dialysis as indicated and discontinue. Admin. impairment, fever, flu-like syndrome, Q Under 18 years, not established. through central venous line strongly hypophosphataemia. D Pregnancy, lactation. recommended. AAdverse Reaction • DContraindications • BSpecial precautions • CDrug interactions
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