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Basic Drug Info
Drug Name:MEGACE
Manufacturer:Bristol-Myers Squibb
Other Info:Distributed by:Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA51-029626-01Revised March 2007



Clinical Trials:


Indications and Usage
MEGACE Oral Suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Cachexia -- General ill health, malnutrition, and weight loss, usually associated with chronic disease.

Acquired Immunodeficiency Syndrome -- An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.

Contraindications

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

Known or suspected pregnancy.
Warnings

Megestrol acetate may cause fetal harm when administered to a pregnant woman.

For animal data on fetal effects, see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility. 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.

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