Drug Catalog - Product Detail
MEGESTROL ACETATE ORAL SUSPENSION SUSP 40MG/ML 473ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 60432-0126-16 | MORTON GROVE PHARMACEUTICALS | 480 | 40MG/ML | SUSPENSION |
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Description
DESCRIPTION Megestrol Acetate Oral Suspension, USP contains megestrol acetate, a synthetic derivative of the 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 Oral Suspension, USP is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL. Megestrol Acetate Oral Suspension, USP contains the following inactive ingredients: alcohol (max. 0.34% v/v from flavor), citric acid anhydrous, lemon-lime flavor, poloxamer 124, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 4.7. Megestrol-01
How Supplied
HOW SUPPLIED Megestrol Acetate Oral Suspension, USP 40 mg/mL is available as a creamy-white, lemon-lime flavored oral suspension, for oral administration, containing 40 mg of micronized megestrol acetate per mL. NDC 60432-126-08 Bottles of 8 fl oz (240mL) NDC 60432-126-16 Bottles of 1 Pint (480 mL)
Indications & Usage
INDICATIONS AND USAGE Megestrol Acetate Oral Suspension, USP 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, USP is 800mg/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.