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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
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Megestrol acetate 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).
Other Treatable Causes
Therapy with megestrol acetate for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, renal disease or psychiatric diseases.
Megestrol acetate is not intended for prophylactic use to avoid weight loss.
There is currently no drug history available for this drug.
Megestrol acetate oral suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17-Hydroxy-6-methyl pregna-4,6-diene-3,20-dione acetate. Solubility at 37° C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.52.
The chemical formula is C 24H 32O 4 and the structural formula is represented as follows:
Figure 1: Megestrol Acetate Chemical Structure
Megestrol acetate oral suspension is an oral suspension containing 125 mg of megestrol acetate per mL.
Megestrol acetate oral suspension contains the following inactive ingredients: alcohol (max. 0.07% v/v from flavor), citric acid monohydrate, hypromellose, lemon flavor, lime flavor, sodium benzoate, sodium citrate dihydrate, sodium lauryl sulfate, and sucrose.
The USP dissolution test is pending.