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:

Strides Pharma Science Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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 64380-160-01 Bottles of 240 mL (8 fl. oz.) NDC 64380-160-02 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. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Revised: 10/21 OS907-01-1-14

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE - MEGESTROL ACETATE SUSPENSION
STRIDES PHARMA SCIENCE LIMITED
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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:
CHEMICAL FORMULA
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
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