Megestrol Acetate

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Megestrol Acetate Recall

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Side Effects & Adverse Reactions

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, 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 pre-existing diabetes mellitus, and overt Cushing’s syndrome have been reported in association with the chronic use of megestrol. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol therapy in the stressed and non-stressed state.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 therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or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 Finally, in patients who are receiving or being withdrawn from chronic megestrol therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions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 (eg., surgery, infection).

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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Uses

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.

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History

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Other Information

Megestrol acetate, is a synthetic, antineoplastic and progestational drug. Megestrol acetate is a white, crystalline solid chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. 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 empirical formula is C24 H32O4 and the structural formula is represented as follows:

Megestrol acetate tablets are supplied for oral administration containing 20 mg or 40 mg megestrol acetate and the following inactive ingredients: acacia, colloidal silicon dioxide, dibasic calcium phosphate, lactose monohydrate, magnesium stearate, and starch (corn).

Sources

Megestrol Acetate Manufacturers

Roxane Laboratories, Inc

Megestrol Acetate | Roxane Laboratories, Inc

Breast Cancer: 160 mg/day (40 mg q.i.d.).

Endometrial Carcinoma: 40 mg/day 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.

No Recall
State Of Florida Doh Central Pharmacy

Megestrol Acetate | State Of Florida Doh Central Pharmacy

Breast cancer: 160 mg/day (40 mg q.i.d.).

Endometrial carcinoma: 40 mg/day 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.

No Recall
Udl Laboratories, Inc.

Megestrol Acetate | Walgreens

adults and children 6 years and over 1 suppository per day or as directed by a doctor
children 2 to under 6 years use Walgreens Infants & Children suppositories
children under 2 years ask a doctor

-Insert 1 suppository well up into the rectum and retain for 15 minutes
-It need not melt to produce laxative action

No Recall
Par Pharmaceutical Inc

Megestrol Acetate | Par Pharmaceutical Inc

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.

No Recall
Major Pharmaceuticals

Megestrol Acetate | Major Pharmaceuticals

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.

No Recall
Physicians Total Care, Inc.

Megestrol Acetate | Physicians Total Care, Inc.

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.

No Recall
Cardinal Health

Megestrol Acetate | Cardinal Health

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.

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Megestrol Acetate | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

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.

No Recall
Barr Laboratories Inc.

Megestrol Acetate | Barr Laboratories Inc.

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 USP.

No Recall
Mckesson Packaging Services A Business Unit Of Mckesson Corporation

Megestrol Acetate | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

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.

No Recall
Cardinal Health

Megestrol Acetate | Cardinal Health

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 USP.

No Recall
Cardinal Health

Megestrol Acetate | Cardinal Health

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 USP.

No Recall