MEGESTROL ACETATE suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MEGESTROL ACETATE (UNII: TJ2M0FR8ES) (MEGESTROL - UNII:EA6LD1M70M)

Available from:

West-Ward Pharmaceuticals Corp.

INN (International Name):

MEGESTROL ACETATE

Composition:

MEGESTROL ACETATE 40 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.

Product summary:

Megestrol Acetate Oral Suspension USP 40 mg per mL oral suspension is supplied as a (lemon-lime flavored) smooth, viscous, white suspension. NDC 0054-3542-58: Bottle of 240 mL (8 fl. oz). Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. Protect from heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
WEST-WARD PHARMACEUTICALS CORP.
REFERENCE LABEL SET ID: B0BACE37-4056-4CA5-9505-8144EDCE403F
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MEGESTROL ACETATE ORAL SUSPENSION USP
DESCRIPTION
Megestrol acetate, is a synthetic derivative of the steroid hormone,
progesterone. Megestrol acetate is
a white to creamy white, crystalline powder chemically designated as
pregna-4,6-diene-3,20-dione, 17-
(acetyloxy)-6-methyl-. Solubility at 37°C in water is 2 mcg per mL,
solubility in plasma is 24 mcg per
mL. Its molecular weight is 384.5. The empirical formula is C
H O and the structural formula is
represented as follows:
Each mL of Megestrol Acetate Oral Suspension USP contains 40 mg of
micronized megestrol acetate
USP and the following inactive ingredients: anhydrous citric acid,
lemon-lime flavor, microcrystalline
cellulose and carboxymethylcellulose sodium, polyoxl 35 castor oil,
purified water, sodium benzoate,
sodium citrate and sucrose.
The suspension meets the requirements of USP Dissolution Test 3 in the
USP monograph for
Megestrol Acetate Oral Suspension USP.
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
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, non-specific 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.
The major route of drug elimination in humans is urin