WARNINGS
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.
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HEMABATE SUMMARY
Hemabate®
carboprost tromethamine
injection, USP
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.
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.
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NEWS HIGHLIGHTS
Published Studies Related to Hemabate (Carboprost)
Method to determine stability and recovery of carboprost and misoprostol in infusion preparations. [2007.09.15]
The two synthetic prostaglandin analogues, carboprost and misoprostol, are used extensively in obstetric and gynaecological practice.
Treatment of early cervical pregnancy with cerclage, carboprost, curettage, and balloon tamponade. [2007.02]
CONCLUSION: Early cervical pregnancy was treated with combined cervical cerclage, intracervical infiltration of carboprost, curettage, and balloon tamponade. Severe hemorrhage during suction curettage and the adverse effects and complications of systemic methotrexate treatment were avoided.
Clinical Trials Related to Hemabate (Carboprost)
Impact of Uterotonic Agents on Isolated Human Myometrium [Recruiting]
The purpose of this study is to compare the ability of a sample of uterine muscle tissue to
contract in the presence of various drugs. The drugs studied are typically used to contract
the uterus when a pregnant patient continues to bleed after delivery. Amongst the
uterotonic drugs (used to contract the uterus), namely oxytocin, ergonovine and carboprost,
the most effective one to use is not known.
The investigators will be testing uterine muscle samples in the presence of these drugs at
various concentrations, to see what their contractility measures over time, as compared with
a control sample, in which no drugs will be applied.
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Page last updated: 2008-01-02
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