Carboprost Tromethamine

Carboprost Tromethamine Injection is indicated for aborting pregnancy between the 13 th and 20 th 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: Failure of expulsion of the fetus during the course of treatment by another method; Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity; Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus; 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. Studies have shown that in such cases, the use of Carboprost Tromethamine Injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome.

In a high proportion of cases, Carboprost Tromethamine Injection used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.

Hypersensitivity (including anaphylaxis and angioedema) to Carboprost Tromethamine Injection Sterile Solution [see ADVERSE REACTIONS, Post-marketing Experience] Acute pelvic inflammatory disease 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.

Carboprost Tromethamine Injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. Carboprost Tromethamine does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by Carboprost Tromethamine could exhibit transient life signs. Carboprost Tromethamine Injection is not indicated if the fetus in utero has reached the stage of viability.

Carboprost Tromethamine Injection should not be considered a feticidal agent. Evidence from animal studies has suggested that certain other prostaglandins have some teratogenic potential. Although these studies do not indicate that Carboprost Tromethamine Injection is teratogenic, any pregnancy termination with Carboprost Tromethamine Injection that fails should be completed by some other means. This product contains benzyl alcohol.