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:

Akorn

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 is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. It is available as follows: Bottles of 240 mL (8 fl. oz.) ………………NDC 50383-859-24 10 mL unit dose in trays of ten cups ………NDC 50383-859-10 Case of 40 ………………………………….NDC 50383-859-11 Case of 100 …………………………………NDC 50383-859-12 20 mL unit dose in trays of ten cups ………..NDC 50383-859-20 Case of 40 …………………………………..NDC 50383-859-21 Case of 100 …………………………………NDC 50383-859-22

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
AKORN
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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 naturally occurring 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, 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: citric acid,
natural and artificial lemon-lime flavor, polyethylene glycol,
polysorbate 80, purified
water, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
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
24
32
4
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,