MEGESTROL ACETATE suspension

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Rxchange Co

INN (Nome Internazionale):

MEGESTROL ACETATE

Composizione:

MEGESTROL ACETATE 40 mg in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

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.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
RXCHANGE CO
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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
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 C24H32O4 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, which may be affected by factors such as
intestinal tract motility, intestinal
bacteri