Drug Catalog - Product Detail
MEGESTROL ACETATE TB 40MG 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0290-05 | PAR PHARMACEUTICAL | 500 | 40MG | TABLET |
PACKAGE FILES
Generic Name
MEGESTROL ACETATE
Substance Name
MEGESTROL ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA072423
Description
DESCRIPTION Megestrol acetate is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17(alpha)-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.51. The molecular formula is C 24 H 32 O 4 and the structural formula is represented as follows: Megestrol acetate is supplied as tablets for oral administration containing 20 mg and 40 mg megestrol acetate. Megestrol acetate tablets contain the following inactive ingredients: acacia spray dried, colloidal silicon dioxide, corn starch, di-calcium phosphate dihydrate powder, lactose hydrous impalpable, magnesium stearate and pregelatinized starch. This is the formula
How Supplied
HOW SUPPLIED Megestrol acetate tablets, 20 mg, are white, round, flat-faced, beveled-edged, bisected, debossed with “Par 289” on one side. They are supplied in bottles of 100’s (NDC #49884-289-01). Megestrol acetate tablets, 40 mg, are white, round, flat-faced, beveled-edged, bisected, debossed with “Par 290” on one side. They are supplied in bottles of 100’s (NDC #49884-290-01), 250’s (NDC #49884-290-04) and 500’s (NDC #49884-290-05). STORAGE Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Protect from temperatures above 40ْC (104ْF). SPECIAL HANDLING Health Hazard Data 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). Women at risk of pregnancy should avoid such exposure. Manufactured by: PAR PHARMACEUTICAL Chestnut Ridge, N.Y. 10977
Indications & Usage
INDICATIONS AND USAGE Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.
Dosage and Administration
DOSAGE AND ADMINISTRATION Breast cancer: 160 mg/day (40 mg q.i.d.). Endometrial carcinoma: 40 to 320 mg/day in divided doses. At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of megestrol acetate.