Megestrol Acetate

Indications

INDICATIONS AND 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 and administration (summary)

DOSAGE AND 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.

Contraindications

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

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.

Pregnancy

Pregnancy Pregnancy Category D. (See WARNINGS section.)

Storage and supply

HOW SUPPLIED Megestrol acetate tablets, 40 mg, are white, round, flat-faced, beveled-edged, bisected, debossed with "Par 290" on one side. They are supplied Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7236-61 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only.

Source: Megestrol Acetate (Megestrol Acetate) — US FDA prescribing information, 2025-09-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.