Carboprost

HEMABATE 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. HEMABATE is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management.

1. Abortion and Indications 1–4 An initial dose of 1 mL of HEMABATE 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. 2. For Refractory Postpartum Uterine Bleeding An initial dose of 250 micrograms of HEMABATE Sterile Solution (1 mL of HEMABATE) is to be given deep, intramuscularly.

1. Hypersensitivity (including anaphylaxis and angioedema) to HEMABATE Sterile Solution 2. Acute pelvic inflammatory disease 3. Patients with active cardiac, pulmonary, renal or hepatic disease

HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. HEMABATE Sterile Solution (carboprost tromethamine), like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. HEMABATE should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities. HEMABATE does not appear to directly affect the fetoplacental unit. Therefore, the possibility does exist that the previable fetus aborted by HEMABATE could exhibit transient life signs. HEMABATE is not indicated if the fetus in utero has reached the stage of viability.

The adverse effects of HEMABATE 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. The pretreatment or concurrent administration of antiemetic and antidiarrheal drugs decreases considerably the very high incidence of gastrointestinal effects common with all prostaglandins used for abortion. Their use should be considered an integral part of the management of patients undergoing abortion with HEMABATE. Of those patients experiencing a temperature elevation, approximately one-sixteenth had a clinical diagnosis of endometritis.

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

HEMABATE must be refrigerated at 2° to 8° C (36° to 46° F).