Megestrol Acetate
FDA Drug Information • Also known as: Megestrol Acetate
- Brand Names
- Megestrol Acetate
- Route
- ORAL
- Dosage Form
- SUSPENSION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Megestrol Acetate Tablets USP are a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as 17α-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. The structural formula is represented as follows: C 24 H 32 O 4 M.W. 384.51 Megestrol Acetate Tablets USP are supplied as tablets for oral administration containing 20 mg or 40 mg megestrol acetate. Inactive Ingredients: Anhydrous lactose, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
What Is Megestrol Acetate Used For?
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
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.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS Weight Gain Weight gain is a frequent side effect of megestrol acetate. 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.
Warnings and 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 acetate in other types of neoplastic disease is not recommended. (See also PRECAUTIONS, Carcinogenesis, Mutagenesis, and 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 preexisting 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
CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation.
Pregnancy and Breastfeeding
Pregnancy Pregnancy Category D. (See WARNINGS section.)
Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate is required for treatment of cancer.
Overdosage
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
HOW SUPPLIED Megestrol Acetate Tablets USP 40 mg: White, round, flat-faced, beveled-edge, scored tablet. Debossed with 555/607 on one side and stylized barr on the other side. NDC: 71335-2544-3: 15 TABLETs in a BOTTLE NDC: 71335-2544-1: 30 TABLETs in a BOTTLE NDC: 71335-2544-2: 100 TABLETs in a BOTTLE 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. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.