PROGESTERONE- progesterone injection, solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Fresenius Kabi USA, LLC

INN (Kansainvälinen yleisnimi):

PROGESTERONE

Koostumus:

PROGESTERONE 50 mg in 1 mL

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. 1.       Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. 2.       Liver dysfunction or disease. 3.       Known or suspected malignancy of breast or genital organs. 4.       Undiagnosed vaginal bleeding. 5.       Missed abortion. 6.       Known sensitivity to progesterone injection.

Tuoteyhteenveto:

The container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F)  [see USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PROGESTERONE - PROGESTERONE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
----------
PROGESTERONE INJECTION, USP
IN SESAME OIL
For intramuscular use only.
Rx only
DESCRIPTION:
Progesterone injection, 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. 314.47
PREGN-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 AND METABOLISM_
ABS ORPTION
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.
DIS TRIBUTION
21
30
2
max
Progesterone is extensively bound to plasma proteins, primarily
albumin (50 to 54%) and cortisol-
binding protein (43 to 48%).
METABOLIS M
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 recyc