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Drug Catalog - Product Detail

MEGESTROL ACETATE ORAL SUSPENSION 40MG/ML 240ML

NDC Mfr Size Str Form
50383-0859-24 AKORN 240 40MG/ML SUSPENSION
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Description
DESCRIPTION Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. 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 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.51. The empirical formula is C 24 H 32 O 4 and the structural formula is represented as follows: megestrol acetate, USP Megestrol acetate oral suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol acetate oral suspension contains the following inactive ingredients: citric acid, natural and artificial lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chemical Structure
How Supplied
HOW SUPPLIED Megestrol Acetate Oral Suspension, USP is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. It is available as follows: Bottles of 240 mL (8 fl. oz.) ………………NDC 50383-859-24 10 mL unit dose in trays of ten cups ………NDC 50383-859-10 Case of 40 ………………………………….NDC 50383-859-11 Case of 100 …………………………………NDC 50383-859-12 20 mL unit dose in trays of ten cups ………..NDC 50383-859-20 Case of 40 …………………………………..NDC 50383-859-21 Case of 100 …………………………………NDC 50383-859-22
Indications & Usage
INDICATIONS AND USAGE 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).
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective. A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience in the 240 mL carton.