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:

Morton Grove Pharmaceuticals, 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, 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 40 mg/mL is available as a creamy-white, lemon-lime flavored oral suspension, for oral administration, containing 40 mg of micronized megestrol acetate per mL. NDC 60432-126-08                Bottles of 8 fl oz (240mL) NDC 60432-126-16                Bottles of 1 Pint (480 mL)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
MORTON GROVE PHARMACEUTICALS, INC.
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MEGESTROL ACETATE
ORAL SUSPENSION, USP
40 MG/ML
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
17α-(acetyloxy)-6-methylpregna-4,6-diene-3,20-dione. Solubility at
37°C in water is 2 µg per mL,
solubility in plasma is 24 µg per mL. Its molecular weight is 384.51.
The empirical formula is
C
H O and the structural formula is represented as follows:
Megestrol Acetate Oral Suspension, USP is supplied as an oral
suspension containing 40 mg of
micronized megestrol acetate per mL. Megestrol Acetate Oral
Suspension, USP contains the following
inactive ingredients: alcohol (max. 0.34% v/v from flavor), citric
acid anhydrous, lemon-lime flavor,
poloxamer 124, propylene glycol, purified water, sodium benzoate,
sodium citrate dihydrate, sucrose
and xanthan gum. It may contain 10% citric acid solution or 10% sodium
citrate solution for pH
adjustment. The pH range is between 3.0 and 4.7.
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 l