Generic

Carboprost Tromethamine

Indications

Carboprost 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:

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.

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.

Dosage & Administration

Abortion and Indications 1-4: An initial dose of 1 mL of Carboprost 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).

The total dose administered of carboprost tromethamine should not exceed 12 milligrams and continuous administration of the drug for more than two days is not recommended.

Interaction

Carboprost may augment the activity of other oxytocic agents. Concomitant use with other oxytocic agents is not recommended.

Contraindications

Hypersensitivity (including anaphylaxis and angioedema) to Carboprost Sterile Solution

Acute pelvic inflammatory disease

Patients with active cardiac, pulmonary, renal or hepatic disease

Side Effects

The most frequent adverse reactions observed are related to its contractile effect on smooth muscle, especially gastrointestinal effects like vomiting, nausea, diarrhea and pyrexia. Endometritis, retained placental fragments, and excessive uterine bleeding occurred as the most common complications after abortion with Carboprost.

Pregnancy & Lactation

Pregnancy category C. Animal studies do not indicate that Carboprost 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

Precautions & Warnings

Use Carboprost by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Use Carboprost cautiously in patients with a history of asthma, hypo- or hypertension, cardiovascular, renal or hepatic disease, anemia, jaundice, diabetes or epilepsy and compromised (scarred) uteri.

In few patients with chorioamnionitis, uterus may not respond to Carboprost.

Cervix should always be carefully examined immediately post-abortion.

Therapeutic Class

Drugs acting on the Uterus

Storage Conditions

No information available.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.