Country: United States
Language: English
Source: NLM (National Library of Medicine)
MEGESTROL ACETATE (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M)
VistaPharm, Inc.
Megestrol Acetate
Megestrol Acetate 40 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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). History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
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 66689-020-01: 10 mL unit dose cup. NDC 66689-020-50: Case contains 50 unit dose cups of 10 mL (NDC 66689-020-01), packaged in 5 trays of 10 unit dose cups each. NDC 66689-020-99: Case contains 100 unit dose cups of 10 mL (NDC 66689-020-01), packaged in 10 trays of 10 unit dose cups each. Store at 20° to 25°C (68° to 77°F). [See USP CONTROLLED ROOM TEMP]. Dispense in a tight container. Protect from heat.
Abbreviated New Drug Application
MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION VISTAPHARM, INC. ---------- MEGESTROL ACETATE ORAL SUSPENSION, USP RX ONLY 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 H O 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. CLINICAL PHARMACOLOGY The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time. There are several analytical methods used to estimate megestrol acetate plasma concentrations, including gas chromatography-mass fragmentography (GC-MF), high 24 32 4 pressure liquid chromatography (HPLC) and radioimmunoassay (RIA). The GC-MF and HPLC methods are specific for megestrol acetate and yield equivalent concentrations. The RIA method reacts to megestrol acetate metabolites and is, therefore, nonspecific and indicates higher concentrations than the GC-MF and HPLC methods. Plasma concentrations are dependent, not only on the method used, but also on intestinal and hepatic inactivation of the drug, which may be affected by factors such as intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet and liver function. Read the complete document