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:

Precision Dose 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 is available as a milky white, lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL. NDC 68094-250-61 10 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-250-62 10 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-361-62 20 mL per unit dose cup Thirty (30) cups per shipper Store the oral suspension between 20° to 25°C (68° to 77°F). [See USP]. Dispense in a tight container. Protect from heat. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MEGESTROL ACETATE- MEGESTROL ACETATE SUSPENSION
PRECISION DOSE INC.
----------
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
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
24
32
4
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