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Questions & Answers
Side Effects & Adverse Reactions
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. HEMABATE 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 HEMABATE is teratogenic, any pregnancy termination with HEMABATE that fails should be completed by some other means.
This product contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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:
- 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.
HEMABATE 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 HEMABATE 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, HEMABATE used in this manner has resulted in the cessation of life threatening bleeding and the avoidance of emergency surgical intervention.
There is currently no drug history available for this drug.
HEMABATE Sterile Solution, 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 is the established name for the active ingredient in HEMABATE. Four other chemical names are:
- (15S)-15-methyl prostaglandin F2α tromethamine salt
- 7-(3α,5α-dihydroxy-2ß-[(3S)-3-hydroxy-3-methyl-trans-1-octenyl]-1α-cyclopentyl]-cis-5-heptenoic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
- (15S)-9α,11α,15-trihydroxy-15-methylprosta-cis-5, trans-13-dienoic acid tromethamine salt
- (15S)-15-methyl PGF2α-THAM
The structural formula is represented below:
The molecular formula is C25H47O8N. The molecular weight of carboprost tromethamine is 489.64. It is a white to slightly off-white crystalline powder. It generally melts between 95° and 105° C, depending on the rate of heating.
Carboprost tromethamine dissolves readily in water at room temperature at a concentration greater than 75 mg/mL.
Each mL of HEMABATE Sterile Solution contains carboprost tromethamine equivalent to 250 mcg of carboprost, 83 mcg tromethamine, 9 mg sodium chloride, and 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. The solution is sterile.