CARBOPROST TROMETHAMINE injection, solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

CARBOPROST TROMETHAMINE (UNII: U4526F86FJ) (CARBOPROST - UNII:7B5032XT6O)

可用日期:

Alembic Pharmaceuticals Inc.

给药途径:

INTRAMUSCULAR

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Carboprost tromethamine injection, USP sterile solution is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion: 1. Failure of expulsion of the fetus during the course of treatment by another method; 2. Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; 3. Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 4. Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion. Carboprost tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unl

產品總結:

Carboprost tromethamine injection USP, 250 mcg/mL sterile solution is available in the following packages: 1 mL single-dose vial           NDC 62332-777-01 10 x 1 mL single-dose vials  NDC 62332-777-10 Each mL of carboprost tromethamine injection USP, 250 mcg/mL  contains carboprost tromethamine equivalent to 250 mcg of carboprost. Carboprost tromethamine injection USP, 250 mcg/mL  must be refrigerated at 2° to 8° C (36° to 46° F). Discard unused portion. 1 Duff, Sanders, and Gibbs; The course of labor in term patients with chorioamnionitis; Am. J. Obstet. Gynecol.; vol. 147, no. 4, October 15, 1983 pp 391–395. Rx Only Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Made in India. Manufactured by: Alembic Pharmaceuticals Limited Karakhadi - 391450, Gujarat, India. Issued: 01/2023

授权状态:

Abbreviated New Drug Application

产品特点

CARBOPROST TROMETHAMINE - CARBOPROST TROMETHAMINE INJECTION, SOLUTION
ALEMBIC PHARMACEUTICALS INC.
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CARBOPROST TROMETHAMINE INJECTION, USP
DESCRIPTION
Carboprost tromethamine injection, USP is a sterile solution, an
oxytocic, contains the
tromethamine salt of the (15S)-15 methyl analogue of naturally
occurring prostaglandin
F2α in a solution suitable for intramuscular injection.
Carboprost tromethamine is the established name for the active
ingredient in carboprost
tromethamine injection, USP. Four other chemical names are:
1. (15S)-15-methyl prostaglandin F2α tromethamine salt
2.
7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-_trans_-1-octenyl]-1α-
cyclopentyl]-_cis_-5-heptenoic acid compound with
2-amino-2-(hydroxymethyl)1,3-
propanediol
3. (15S)-9α,11α,15-trihydroxy-15-methylprosta-_cis_-5,_
trans_-13-dienoic acid
tromethamine salt
4. (15S)-15-methyl PGF2α-THAM
The structural formula is represented below:
The molecular formula is C
H
O N. The molecular weight of carboprost tromethamine
is 489.64. It is a white to slightly off-white crystalline powder. It
generally melts between
95° and 105° C, depending on the rate of heating.
Carboprost tromethamine dissolves readily in water at room temperature
at a
concentration greater than 75 mg/mL.
Each mL of carboprost tromethamine injection, USP sterile solution
contains carboprost
tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine,
9 mg
sodium chloride, and 9.45 mg benzyl alcohol added as preservative.
When necessary,
pH is adjusted with sodium hydroxide and/or hydrochloric acid. The
solution is sterile.
25
47
8
CLINICAL PHARMACOLOGY
Carboprost tromethamine administered intramuscularly stimulates in the
gravid uterus
myometrial contractions similar to labor contractions at the end of a
full term
pregnancy. Whether or not these contractions result from a direct
effect of carboprost
on the myometrium has not been determined. Nonetheless, they evacuate
the products
of conception from the uterus in most cases.
Postpartum, the result