MEDROXYPROGESTERONE ACETATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Cardinal Health

INN (Tên quốc tế):

medroxyprogesterone acetate

Thành phần:

medroxyprogesterone 10 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

New Drug Application Authorized Generic

Đặc tính sản phẩm

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