MEGACE ES- 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:

Stat Rx USA

INN (International Name):

MEGESTROL ACETATE

Composition:

MEGESTROL ACETATE 125 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Megace ® ES (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:

Megace ® ES (megestrol acetate) oral suspension is a concentrated formula available as a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL. Store Megace ® ES (megestrol acetate) oral suspension between 15º to 25º C (59º to 77º F) and dispense in a tight container. Protect from heat. Health Hazard Data 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 sections). Women at risk of pregnancy should avoid such exposure. Manufactured by: PAR PHARMACEUTICAL COMPANIES, INC. Spring Valley, New York 10977 Megace ® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.

Authorization status:

New Drug Application

Summary of Product characteristics

MEGACE ES - MEGESTROL ACETATE SUSPENSION
STAT RX USA
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MEGACE ES (MEGESTROL ACETATE ORAL SUSPENSION) SUSPENSION
DESCRIPTION
Megace
ES (megestrol acetate) oral suspension 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:
Megace
ES (megestrol acetate) is a concentrated formula supplied as an oral
suspension containing
125 mg of megestrol acetate per mL.
Megace
ES (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,
hydroxypropyl methylcellulose (hypromellose), natural and artificial
lemon flavor, purified water,
sodium benzoate, sodium citrate dihydrate, and sucrose.
CLINICAL PHARMACOLOGY
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 liver
function.
Mechanism of Action
Several investigators have reported on the appetite enhancing property
of megestrol acetate and its
possible use in cachexia. The precise mechan