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:

Cardinal Health 107, LLC

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 and is available in the following oral dosage forms: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from heat. Shake well immediately before dosing . 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
CARDINAL HEALTH 107, LLC
----------
MEGESTROL ACETATE ORAL SUSPENSION USP
40 MG/ML
I07761019 R10/19
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,
poloxamer124, 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.
24
32
4
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
weigh