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Megestrol Acetate Tablets

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Megestrol Acetate Tablets

INDICATIONS

Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., 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

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.

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 #49884-290-04) 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 40°C (104°F).

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 COMPANIES, INC. Spring Valley, NY 10977. Revised: 09/07. FDA Rev date: 1/16/2003

Last reviewed on RxList: 6/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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