Apit

Megestrol Acetate USP


Composition:
Apit-40: Each film coated tablet contains Megestrol Acetate USP 40mg.
Apit-160: Each film coated tablet contains Megestrol Acetate USP 160mg.

Indications: Megestrol Acetate is 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. It is also indicated for the treatment of anorexia, cachexia, or weight loss secondary to metastatic cancer.

Dosage and Administration:

Breast Cancer: 160mg/day (160mg taken once daily). Endometrial Carcinoma: 40 to 320mg/day in divided doses (40-80mg one to four times daily or one to two 160mg tablets daily). At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of Megestrol Acetate. Cachexia: 400 to 800mg/day. Use in Children: Safety and effectiveness in pediatric patients have not been established. Use in the Elderly: Insufficient data from clinical studies of Megestrol Acetate are available for patients 65 years of age 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. Maximu Tolerated Daily Dose: Breast Cancer: 160mg/day. Endometrial Carcinoma: 320mg/day. Cachexia: 800mg/day. Or, as directed by the registered physicians.

Use in Pregnancy: Pregnancy Category D. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Use in Lactation: Because many drugs are excreted in human breast milk and because of the potential for adverse reactions in nursing infants, nursing should be discontinued when receiving Megestrol Acetate therapy.

Packing:

Apit-40: Each box contains 30 tablets in Alu-Alu blister pack.

Apit-160: Each box contains 30 tablets in Alu-Alu blister pack.

Prescribing Description

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