Megestrol Acetate

INDICATIONS AND USAGE 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 qid). 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 tablets.

CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation.

ADVERSE REACTIONS Weight Gain Weight gain is a frequent side effect of megestrol. This gain has been associated with increased appetite and is not necessarily associated with fluid retention. Thromboembolic Phenomena Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported. Glucocorticoid Effects (See WARNINGS section.) Other Adverse Reactions Heart failure, nausea and vomiting, edema, breakthrough menstrual bleeding, dyspnea, tumor flare (with or without hypercalcemia), hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash. To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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. Chemical structure

OVERDOSAGE No serious unexpected side effects have resulted from studies involving megestrol acetate administered in dosages as high as 1600 mg/day. Oral administration of large, single doses of megestrol acetate (5 g/kg) did not produce toxic effects in mice. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility it is postulated that this would not be an effective means of treating overdose.

HOW SUPPLIED Megestrol acetate tablets, USP are available as: 20 mg: White, round, flat-faced, beveled-edge, scored tablet. Debossed with 555/606 on one side and stylized b on the other side. Available in bottles of 100 (NDC 0555-0606-02) Tablets. 40 mg: White, round, flat-faced, beveled-edge, scored tablet. Debossed with 555/607 on one side and stylized barr on the other side. Available in bottles of 100 (NDC 0555-0607-02) Tablets. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children.