Carboprost

Indications

INDICATIONS AND USAGE Carboprost tromethamine injection, USP 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, unless contraindicated, intramuscular ergot preparations.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION 1. Abortion and Indications 1-4 An initial dose of 1 mL of carboprost tromethamine injection sterile solution (containing the equivalent of 250 micrograms of carboprost) is to be administered deep in the muscle with a tuberculin syringe. Subsequent doses of 250 micrograms should be administered at 1½ to 3½ hour intervals depending on uterine response. An optional test dose of 100 micrograms (0.4 mL) may be administered initially. The dose may be increased to 500 micrograms (2 mL) if uterine contractility is judged to be inadequate after several doses of 250 micrograms (1 mL).

Contraindications

CONTRAINDICATIONS 1. Hypersensitivity (including anaphylaxis and angioedema) to carboprost tromethamine injection Sterile Solution [ see ADVERSE REACTIONS, Post-marketing Experience ] 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease WARNINGS Carboprost tromethamine injection sterile solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages.

Pregnancy

Pregnancy: Teratogenic Effects: Animal studies do not indicate that carboprost tromethamine is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.

Storage and supply

HOW SUPPLIED Carboprost tromethamine injection, USP is available in the following packages: 1 mL single-dose vials NDC 43598-917-11 10 x 1 mL single-dose vials NDC 43598-917-58 Each mL of carboprost tromethamine injection contains carboprost tromethamine equivalent to 250 mcg of carboprost.

Source: Carboprost Tromethamine (Carboprost Tromethamine) — US FDA prescribing information, 2024-12-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.