CARBOPROST TROMETHAMINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eugia US LLC

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carboprost tromethamine injection 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

Product summary:

Carboprost tromethamine injection, USP is a sterile, clear colorless solution and is available in the following package: 250 mcg per mL 1 mL Single-Dose Vials                                                          NDC 55150-459-01 Packaged in a Carton of 10                                                     NDC 55150-459-10 Each mL of carboprost tromethamine injection, USP contains carboprost tromethamine, USP equivalent to 250 mcg of carboprost. Carboprost tromethamine injection, USP must be refrigerated at 2° to 8°C (36° to 46°F). Discard unused portion. The vial stopper is not made with natural rubber latex. This product's label may have been updated. For current full prescribing information, please visit eugiaus.com. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad – 500032 India Revised: April 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CARBOPROST TROMETHAMINE - CARBOPROST TROMETHAMINE INJECTION, SOLUTION
EUGIA US LLC
----------
CARBOPROST TROMETHAMINE INJECTION, USP
RX ONLY
DESCRIPTION
Carboprost tromethamine injection, USP 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. 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 off-white powder. It generally melts
between 95° and 105° C,
depending on the rate of heating.
Carboprost tromethamine, USP 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, USP equivalent to 250 mcg of carboprost, 83 mcg
tromethamine, 9 mg
sodium chloride, and 9.45 mg benzyl alcohol added as preservative.
When necessary,
25
47
8
pH is adjusted with sodium hydroxide and/or hydrochloric acid. The
solution is sterile.
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 resultant myometrial contractions provide hemostasis
at the site of