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:

Physicians Total Care, Inc.

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 is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. Bottles of 240 mL (8 fl. oz.)          NDC 54868-5389-0 Bottles of 480 mL (16 fl. oz.)        NDC 54868-5389-1 Store the oral suspension between 20°-25°C (68°-77°F). [See USP]. Dispense in a tight container. Protect from heat. 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 sections). Women at risk of pregnancy should avoid such exposure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE - MEGESTROL ACETATE SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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MEGESTROL ACETATE ORAL SUSPENSION
400 MG PER 10 ML - 800 MG PER 20 ML
R ONLY
DESCRIPTION
Megestrol acetate oral suspension contains megestrol acetate, a
synthetic derivative of the naturally
occurring 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 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
Several investigators have reported on the appetite enhancing property
of megestrol acetate and its
possible use in cachexia. 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,