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.
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).
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).
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