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.
