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Drug Catalog - Product Detail

MEGESTROL ACETATE ORAL SUSPENSION SUSP 40MG/ML 473ML

NDC Mfr Size Str Form
49884-0907-61 PAR PHARMACEUTICAL 480 40MG/ML SUSPENSION
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Generic Name
MEGESTROL ACETATE
Substance Name
MEGESTROL ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075671
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 17-Hydroxy-6-methylpregna-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 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: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, glycerin, natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, sucrose and xanthan gum. Megestrol acetate oral suspension, 40 mg/mL complies with USP Dissolution Test 2. this is the 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. NDC 49884-907-38 Bottles of 240 mL (8 fl. oz.) NDC 49884-907-61 Bottles of 480 mL (16 fl. oz.) STORAGE Store the oral suspension between 20° to 25°C (68° to 77°F). [See USP]. Dispense in a tight container. Protect from heat. SPECIAL HANDLING Health Hazard Data: There is no threshold limit value established by OSHA, NIOSH, or ACGIH. Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS ). Women at risk of pregnancy should avoid such exposure. Manufactured by: PAR PHARMACEUTICAL Chestnut Ridge, NY 10977 Revised: 10/2019 OS907-01-1-13
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 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.