MEDROXYPROGESTERONE ACETATE tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

medroxyprogesterone acetate (UNII: C2QI4IOI2G) (medroxyprogesterone - UNII:HSU1C9YRES)

Доступно од:

Cardinal Health

INN (Међународно име):

medroxyprogesterone acetate

Састав:

medroxyprogesterone 10 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

New Drug Application Authorized Generic

Карактеристике производа

MEDROXYPROGESTERONE ACETATE- MEDROXYPROGESTERONE ACETATE TABLET
CARDINAL HEALTH
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MEDROXYPROGESTERONE ACETATE TABLETS, USP
DESCRIPTION
Medroxyprogesterone acetate tablets contain medroxyprogesterone
acetate, which is a derivative of
progesterone. It is a white to off-white, odorless crystalline powder,
stable in air, melting between 200
and 210°C. It is freely soluble in chloroform, soluble in acetone and
in dioxane, sparingly soluble in
alcohol and in methanol, slightly soluble in ether, and insoluble in
water.
The chemical name for medroxyprogesterone acetate is
Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-
methyl-, (6α)-. The structural formula is:
Each tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of
medroxyprogesterone acetate.
Inactive ingredients: calcium stearate, corn starch, lactose, mineral
oil, sorbic acid, sucrose, talc. The
2.5 mg tablet contains FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY
Medroxyprogesterone acetate, administered orally or parenterally in
the recommended doses to women
with adequate endogenous estrogen, transforms proliferative into
secretory endometrium. Androgenic
and anabolic effects have been noted, but the drug is apparently
devoid of significant estrogenic
activity. While parenterally administered medroxyprogesterone acetate
inhibits gonadotropin
production, which in turn prevents follicular maturation and
ovulation, available data indicate that this
does not occur when the usually recommended oral dosage is given as
single daily doses.
PHARMACOKINETICS
The pharmacokinetics of medroxyprogesterone acetate were determined in
20 postmenopausal women
following a single-dose administration of eight medroxyprogesterone
acetate tablets 2.5 mg or a single
administration of two medroxyprogesterone acetate tablets 10 mg under
fasting conditions. In another
study, the steady-state pharmacokinetics of medroxyprogesterone
acetate were determined under fasting
conditions in 30 postmenopausal women following daily administration
of one medroxyprogesterone
acetate tablet