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The most comprehensive introduction for Megestrol acetate powder (595335) .pdf

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The most comprehensive introduction for Megestrol acetate
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.




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. 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

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


It has properties that interfere with the normal estrogen

This interferes with the stimulation of cell growth in estrogen



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.




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.




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








acetate powder, call your doctor immediately. megestrol acetate powder
may harm the fetus. Do not breast-feed while you are taking megestrol
acetate powder.




♦ 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.











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.



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



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.




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.



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:

· weight gain

· changes in appetite

· stomach upset

· diarrhea



· gas

· skin rash

· trouble sleeping (insomnia)

· weakness

· decreased sexual ability/desire

· impotence

· trouble having an orgasm

· fever









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



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

Megestrol acetate (595-33-5) is a progestational agent with a powerful effect
on appetite. It was

initially used as a contraceptive agent; however, the


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.




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




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.




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®

♣ www.aasraw.com



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