Drug Facts
Composition & Profile
Identifiers & Packaging
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 #64380-158-01). 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 #64380-159-01), 250's (NDC #64380-159-02) and 500's (NDC #64380-159-03). STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from temperatures above 40 0 C (104 0 F).; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 158 -01 Megestrol Acetate Tablets, USP 20 mg Strides Pharma Inc. 100 Tablets Rx only 64380-158-01; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -01 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 100 Tablets Rx only 64380-159-01; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -02 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 250 Tablets Rx only 40 mg label - 250 tablets; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -03 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 500 Tablets Rx only 40 mg label - 500 tablets
- 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 #64380-158-01). 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 #64380-159-01), 250's (NDC #64380-159-02) and 500's (NDC #64380-159-03). STORAGE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from temperatures above 40 0 C (104 0 F).
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 158 -01 Megestrol Acetate Tablets, USP 20 mg Strides Pharma Inc. 100 Tablets Rx only 64380-158-01
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -01 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 100 Tablets Rx only 64380-159-01
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -02 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 250 Tablets Rx only 40 mg label - 250 tablets
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 64380- 159 -03 Megestrol Acetate Tablets, USP 40 mg Strides Pharma Inc. 500 Tablets Rx only 40 mg label - 500 tablets
Overview
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
Indications & Usage
Megestrol acetate tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (ie, recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.
Dosage & 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.
Warnings & Precautions
WARNINGS Megestrol acetate may cause fetal harm when administered to a pregnant woman. Fertility and reproduction studies with high doses of megestrol acetate have shown a reversible feminizing effect on some male rat fetuses. 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 (receiving) 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. The use of megestrol in other types of neoplastic disease is not recommended. (See also PRECAUTIONS, Carcinogenesis, Mutagenesis, Impairment of Fertility section.) The glucocorticoid activity of megestrol acetate tablets has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness. (e.g., surgery, infection).
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.
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