Megace

Unless your doctor tells you otherwise, continue your normal diet.

The recommended dose for stimulating appetite is 800 mg per day of the regular megestrol suspension (40 mg/ml) or 625 mg per day of the ES formulation (125 mg/ml). Breast cancer is treated with 40 mg four times daily.

Tablets: 20 and 40 mg. Oral suspension: 40 mg/mL or 125 mg/mL.

Megestrol should be stored in a dry place at room temperature, 15 C-25 C (59 F-77 F).

Megace is a prescription medication used to relieve the symptoms of advanced breast cancer or endometrial cancer. It is also used to treat loss of appetite and weight loss in patients with AIDS. 

Megace belongs to a group of drugs called progestins. It is unknown exactly how Megace works, but it is thought to change the activity of female hormones that are involved in cancer growth. It promotes weight gain by increasing appetite.

This medication comes in tablet, liquid suspension, and concentrated suspension forms to be taken by mouth.

The tablets and suspension are usually taken several times a day. The concentrated suspension is usually taken once a day.

Common side effects of Megace include gas, difficulty falling asleep or staying asleep, and impotence (the inability to develop or maintain an erection of the penis during sexual activity).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Megestrol is a man-made chemical similar to the female hormone progesterone.

Megestrol is used to treat loss of appetite and weight loss in people with acquired immunodeficiency syndrome (AIDS). Megestrol is also used in the treatment of advanced breast cancer and endometrial cancer.

Megestrol may also be used for purposes not listed in this medication guide.

Administration

Oral Administration

Administer orally.138 a b

Manufacturer makes no specific recommendations regarding administration with meals.a

Oral suspensions containing 200 mg/5 mL are not bioequivalent or interchangeable on a mg-per-mg basis with the oral suspension containing 625 mg/5 mL (Megace ES).138 (See Plasma Concentrations under Pharmacokinetics.)

Dosage

Available as megestrol acetate; dosage expressed in terms of the salt.138 a b

Adults

160 mg daily in 4 equally divided doses (40 mg 4 times daily); continue therapy for at least 2 months to determine antineoplastic effectiveness.b

Dosages of 480-1600 mg daily in divided doses have been used in clinical trials.100 108 110 114

40–320 mg daily in divided doses; continue therapy for at least 2 months to determine antineoplastic effectiveness.b

Initially, 800 mg daily (20 mL per day).121 122 126 127 128 130 a

In clinical trials, 400 mg daily also has been used effectively.a

Initially, 625 mg daily.138

Clinically effective dosages are expected to range from 312.5–625 mg daily.138

480–600 mg daily generally have been used.c However, some patients may exhibit weight gain with dosages as low as 160 mg daily.c

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.138 a b

Renal Impairment

No specific dosage recommendations at this time.138 a b (See Renal Impairment under Cautions.)

Geriatric Patients

Treatment of cachexia in HIV-infected individuals: Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.138

Treatment of breast cancer or endometrial cancer: No specific dosage recommendations at this time.b

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration usually attained within 1–5 hours.c

Plasma Concentrations

Plasma concentrations achieved with a 625-mg dose of the concentrated oral suspension (Megace ES 625 mg/5 mL) are equivalent to those achieved with an 800-mg dose of the original formulation (200 mg/5 mL) under fed conditions.138

Elimination

Metabolism

Completely metabolized in the liver to free steroids and glucuronide conjugates.

Elimination Route

Excreted principally in urine (about 66%) and in feces (about 20%).138 a b

Use Megace as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Megace.
• Make sure you have the right liquid; there is more than one strength.

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Headache.
• More hungry.
• Weight gain.
• Not able to sleep.
• Gas.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Megace® (megestrol acetate tablets, USP) is available as light blue, scored tablets containing 20 mg or 40 mg megestrol acetate, USP. Bottles contain a desiccant canister.

STORAGE

Store at 25° C (77° F); excursions permitted to 15° C - 30° C (59° F - 86° F) [see USP Controlled Room Temperature]. Protect from temperatures above 40° C (104° F).

SPECIAL HANDLING

There is no threshold limit value established by OSHA, NIOSH, or ACGIH.

Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS sections). Women at risk of pregnancy should avoid such exposure.

Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Rev January 2003