Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y)
American Regent, Inc.
PROGESTERONE
PROGESTERONE 50 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
PROGESTERONE - PROGESTERONE INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- 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 Lugege kogu dokumenti