www.aasraw.com
The most comprehensive introduction for Megestrol acetate powder(595-33-5) The most comprehensive introduction for Megestrol acetate powder(595-33-5)............................1 1. Megestrol acetate reviews(CAS:595-33-5)..................................................................................... 1 2. How Does Megestrol acetate work?............................................................................................... 3 3. How is megestrol acetate powder best taken?...............................................................................5 4. What special precautions Before taking megestrol acetate powder?........................................... 6 5. How should I take megestrol acetate powder?.............................................................................. 7 6. Use Megestrol acetate Powder in specific populations..................................................................8 7. What should I know about storage and disposal of this medication?......................................... 11 8. Megestrol acetate side effects...................................................................................................... 12 9. Megestrol Acetate Use for Weight Gain Should Be Carefully Considered................................... 14 10. What is the most important information I should know about Megestrol Acetate powder?...17 11. Where can I get more information on Megestrol Acetate?....................................................... 18
1. Megestrol acetate reviews(CAS:595-33-5)
Megestrol acetate powder is a type of hormone treatment. It is also called Megace or megestrol(595-33-5). It is a man made version of the hormone progesterone. Progesterone is one of the female hormones but men also produce a small amount of it.
1
aas11@aasraw.com
www.aasraw.com
Megestrol acetate powder is a treatment for the following cancers that have come back or spread from where they started.
♌ breast cancer ♌ womb cancer
It is also a treatment for poor appetite. Your doctor might suggest you take it if you have lost weight because of cancer or its treatment. Doctors might also use it as a treatment for women who have hot flushes due to their cancer or its treatment.
2
aas11@aasraw.com
www.aasraw.com
2. How Does Megestrol acetate work?
Megestrol acetate is a type of hormone therapy. Hormones are chemical substances that are produced by glands in the body, which enter the bloodstream and cause effects in other tissues. (For example, the hormone testosterone made in the testicles is responsible for male characteristics such as deepening voice and increased body hair). The use of hormone therapy to treat cancer is based on the observation that receptors for specific hormones that are needed for cell growth are on the surface of some tumor cells.
Hormone therapies work by; stopping the production of a certain
hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell. The different types of hormone therapies are categorized by their function and/or the type of hormone that is effected.
Megestrol acetate is a progestin (a man-made form of the hormone progesterone). cycle.
3
It has properties that interfere with the normal estrogen
This interferes with the stimulation of cell growth in estrogen
aas11@aasraw.com
www.aasraw.com
dependent tumor cells. There is also thought to be some direct effect on the lining of the uterine wall (endometrium).
A side effect of Megestrol acetate has been weight gain.
The exact
mechanism of this effect is unclear, however the effects lead to an increase in body fat. Taking advantage of this side effect, Megestrol acetate has been studied and used to treat severe appetite loss (anorexia), muscle wasting (cachexia) and weight loss associated with cancer and AIDS.
4
aas11@aasraw.com
www.aasraw.com
3. How is megestrol acetate powder best taken?
Use this medicine (Megestrol acetate powder) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
♦ To gain the most benefit, do not miss doses. ♦ Keep taking this medicine (Megestrol acetate powder) as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
♦ Take a missed dose as soon as you think about it. ♦ If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
♦ Do not take 2 doses at the same time or extra doses.
5
aas11@aasraw.com
www.aasraw.com
4. What special precautions Before taking megestrol acetate powder?
♦
tell your doctor and pharmacist if you are allergic to megestrol
acetate powder, any other medications, or any of the inactive ingredients in megestrol acetate powder, suspension, or concentrated suspension. Ask your doctor or pharmacist for a list of the inactive ingredients.
♦ tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention antibiotics and indinavir (Crixivan). Your doctor may need to adjust the doses of your medications or monitor you carefully for side effects.
♦ tell your doctor if you have or have ever had a blood clot anywhere in the body, a stroke, diabetes, or kidney or liver disease.
♦ tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.
If
you
become
pregnant
while
taking
megestrol
acetate powder, call your doctor immediately. megestrol acetate powder may harm the fetus. Do not breast-feed while you are taking megestrol acetate powder.
6
aas11@aasraw.com
www.aasraw.com
♌ you should know that megestrol acetate powder may interfere with the normal menstrual cycle (period) in women. However, you should not assume that you cannot become pregnant. Use a reliable method of birth control to prevent pregnancy.
♌ if you are having surgery, including dental surgery, during or shortly after your treatment, tell the doctor or dentist that you are taking megestrol acetate powder.
5. How should I take megestrol acetate powder?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. 7
aas11@aasraw.com
www.aasraw.com
Megace
ES
contains
a
higher
concentration
of
megestrol
acetate powder than Megace. If your doctor changes your brand, strength, or type of megestrol acetate powder, your dosage needs may change. Ask your pharmacist if you have any questions about the medicine you receive at the pharmacy.
Your dosage needs may change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice. Store at room temperature away from moisture and heat.
6. Use Megestrol acetate Powder in specific populations
♣ Pregnancy
Pregnancy Category X [see Warnings and Precautions (5.2)]. No adequate animal teratology information is available at clinically relevant doses. 8
aas11@aasraw.com
www.aasraw.com
Pregnant rats treated with low doses of Megestrol acetate powder (0.02-fold the recommended clinical dose) resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses.
♣ Nursing Mothers
Because of the potential for adverse effects on the newborn, nursing should be discontinued if Megestrol acetate powder is required.
♣ Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
♣ Geriatric Use
Clinical studies of Megestrol acetate powder in the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses 9
aas11@aasraw.com
www.aasraw.com
between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Megestrol acetate powder
is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
♣ Use in Women
Megestrol acetate powder has had limited use in HIV infected women. All 10 women in the clinical trials reported breakthrough bleeding. Megestrol acetate powder is a progesterone derivative, which may induce vaginal bleeding in women.
10
aas11@aasraw.com
www.aasraw.com
7. What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. 11
aas11@aasraw.com
www.aasraw.com
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. find www.aasraw.com for more information if you do not have access to a take-back program.
8. Megestrol acetate side effects
Megace (megestrol acetate, USP) Oral Suspension is a man-made chemical similar to the female hormone progesterone used to treat loss of appetite and weight loss because of disease, and is also used in the treatment of advanced breast cancer and endometrial cancer. Megace is available in generic form. Common side effects of Megace include:
路 weight gain
路 changes in appetite
路 stomach upset
路 diarrhea 12
aas11@aasraw.com
www.aasraw.com
· gas
· skin rash
· trouble sleeping (insomnia)
· weakness
· decreased sexual ability/desire
· impotence
· trouble having an orgasm
· fever
Women
may
experience
changes
in
menstrual
periods,
including
unpredictable vaginal bleeding.The recommended adult initial dosage of Megace Oral Suspension is 800 mg/day (20 mL/day). Megace may interact with insulin or oral diabetes medicine and may decrease the effects of these medications, and blood sugar levels may increase. If you have diabetes, monitor blood sugar and talk to your doctor if you notice unusual changes. Megace may interact with indinavir, or insulin or oral diabetes medications. Tell your doctor all medications and supplements you use. Megace must not 13
aas11@aasraw.com
www.aasraw.com
be used during pregnancy. It may cause harm to a fetus. Women of childbearing age should use birth control while using this medication. This medication may pass into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug.
Our Megace (megestrol acetate, USP) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
9. Megestrol Acetate Use for Weight Gain Should Be Carefully Considered
Megestrol acetate (595-33-5) is a progestational agent with a powerful effect on appetite. It was 14
initially used as a contraceptive agent; however, the aas11@aasraw.com
www.aasraw.com
common side effect of weight gain led to its current use as an orexigenic agent. Administration of MA results in substantial increases in appetite and body weight in patients with HIV-associated wasting and in those with cancer. MA is currently Food and Drug Administration (FDA) approved for HIV-associated weight loss. In addition, both in healthy, community-dwelling older individuals and elderly people residing in long-term care facilities, the use of MA results in a robust increase in body weight. The use of orexigenic agents such as MA in these settings is appropriate because involuntary weight loss has been associated with increased mortality. Indeed, MA has a greater effect on body weight and appetite than other orexigenic agents such as dronabinol and eicospentaenoic acid. However, in older people and patients with cancer or renal failure, fat is the principal or the only constituent of weight gain, with little accrual of skeletal muscle or other components of fat-free mass. Among the many side effects of the use of MA, suppression of testosterone and estrogen production is prominent. Before the common use of other effective androgen suppressive treatments (flutamide, bicalutamide) in men with prostate cancer, MA was commonly used in this setting. Indeed, in older men, use of MA results in near-castrate levels of testosterone. MA has also been used to suppress estrogen levels in women with breast cancer.
15
aas11@aasraw.com
www.aasraw.com
The study published this month in JCEM examined the combined effects of testosterone and MA on the composition of weight gain in patients with HIV-associated wasting. This study demonstrates, once again, that MA has a substantial effect on appetite and body weight, with fat gain the principal component of the increase in body weight. However, fat-free mass was also increased along with total body weight in this trial, similar to a previous examination of the effect of MA on weight gain in patients with HIV-associated weight loss. Mulligan et al.showed that testosterone was suppressed, and testosterone replacement had no effect on the composition of the weight gain; furthermore, MA administration resulted in decreased libido. This suppressive effect of MA on testosterone production and in blocking the effects of testosterone on lean body mass accrual should be
16
aas11@aasraw.com
www.aasraw.com
carefully considered before using MA in this patient population. Loss of lean mass in HIV patients is strongly linked to low androgen levels.
A number of unanswered questions concerning the effects of MA remain. Its use must be carefully considered and carefully managed. If an improvement in appetite and a gain in fat mass are desirable goals in the management of cachexia or involuntary weight loss, MA remains one of the most potent orexigenic agents currently available. Its use must be weighed against the potential for adrenal suppression and suppression of androgen production. Because of its antiandrogen properties, the antianabolic effects of MA are not ameliorated by testosterone administration.
10. What is the most important information I should know about Megestrol Acetate powder?
Megestrol acetate powder can harm an unborn baby or cause birth defects. Do not use megestrol if you are pregnant.
17
aas11@aasraw.com
www.aasraw.com
Before you take megestrol acetate powder, tell your doctor if you have diabetes or a history of stroke or blood clot.
Your dosage needs may change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice.
Megace ES contains a higher concentration of megestrol acetate powder than Megace. Ask your pharmacist if you have any questions about the medicine you receive at the pharmacy.
11. Where can I get more information on Megestrol Acetate?
♣ CAS: 595-33-5
♣ Brand name: Megace®, Megace® ES
♣ www.aasraw.com
18
aas11@aasraw.com