Overview
DESCRIPTION Carboprost tromethamine injection, USP 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 injection, USP is the established name for the active ingredient carboprost tromethamine, USP. Four other chemical names are: 1.
Mechanism of Action
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 placentation. Carboprost tromethamine also stimulates the smooth muscle of the human gastrointestinal tract. This activity may produce the vomiting or diarrhea or both that is common when carboprost tromethamine is used to terminate pregnancy and for use postpartum.
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.
Common Doses
- 1 mL
- 0.4 mL
- 2 mL
Dosage
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.
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.
Side Effects
- ADVERSE REACTIONS The adverse effects of carboprost tromethamine sterile solution are generally transient and reversible when therapy ends. The most frequent adverse reactions observed are related to its contractile effect on smooth muscle. In patients studied, approximately two-thirds experienced vomiting and diarrhea, approximately one-third had nausea, one-eighth had a temperature increase greater than 2° F, and one-fourteenth experienced flushing.
Interactions
- Drug Interactions Carboprost tromethamine may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.