PROGESTERONE - progesterone injection, solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)

Доступна с:

American Regent, Inc.

ИНН (Международная Имя):

PROGESTERONE

состав:

PROGESTERONE 50 mg in 1 mL

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

This drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. - Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. - Liver dysfunction or disease. - Known or suspected malignancy of breast or genital organs. - Undiagnosed vaginal bleeding. - Missed abortion. - Known sensitivity to progesterone injection, USP.

Обзор продуктов:

Progesterone Injection USP, 50 mg/mL is available in 10 mL multiple dose vials, individually boxed. (NDC 0517-0750-01) Store at 20° C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature]. Revised: December  2009

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

PROGESTERONE - PROGESTERONE INJECTION, SOLUTION
AMERICAN REGENT, INC.
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PROGESTERONE INJECTION, USP
IN SESAME OIL
FOR INTRAMUSCULAR USE ONLY
RX ONLY
DESCRIPTION
Progesterone injection, USP, a progestin, is a sterile solution of
progesterone in a suitable vegetable
oil available for intramuscular use.
Progesterone occurs as a white or creamy white, crystalline powder. It
is odorless and is stable in air.
Practically insoluble in water, it is soluble in alcohol, acetone, and
dioxane and sparingly soluble in
vegetable oils.
It has the following structural formula:
C H O M.W. 314 .4 7 PREG N-4 -ENE-3, 20-DIONE
Each mL contains: Progesterone 50 mg, Benzyl Alcohol 10% as
preservative in Sesame Oil q.s.
CLINICAL PHARMACOLOGY
Transforms proliferative endometrium into secretory endometrium.
Inhibits (at the usual dose range) the secretion of pituitary
gonadotropins, which in turn prevents
follicular maturation and ovulation.
PHARMACOKINETICS
_Absorption:_
21
30
2
After intramuscular administration of 10 mg of progesterone in oil
maximum plasma concentrations
(geometric mean of 7 ng/mL) were reached within approximately 8 hours
after injection and plasma
concentrations remained above baseline for about 24 hours after
injection. Injection of 10, 25, and 50
mg resulted in geometric mean values for maximum plasma concentration
(C
) of 7, 28, and 50
ng/mL, respectively.
_Distribution:_
Progesterone is extensively bound to plasma proteins, primarily
albumin (50 to 54%) and cortisol-
binding protein (43 to 48%).
_Metabolism:_
Progesterone is metabolized primarily in the liver by reduction to
pregnanediol, pregnanetriol and
pregnanolone. Subsequent conjugation results in the formation of
glucuronide and sulfate metabolites.
The mean plasma metabolic clearance rate in cycling women is 2510 ±
135 (SEM) L/day.
_Excretion:_
The glucuronide and sulfate conjugates of pregnanediol and
pregnanolone are excreted in the urine and
bile. Progesterone metabolites which are excreted in the bile may
undergo enterohepatic recycling or