HEMABATE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HEMABATE (HEMABATE).
HEMABATE (carboprost tromethamine) is a synthetic prostaglandin analog of PGF2α. It stimulates uterine myometrial contractions, leading to expulsion of uterine contents and control of postpartum hemorrhage.
| Metabolism | Primarily metabolized via reduction of the 15-hydroxyl group and oxidation of the 13,14-double bond; excreted mainly in urine as metabolites. |
| Excretion | Primarily metabolized in lungs, liver, and plasma to 15-keto-13,14-dihydro-PGF2α and other metabolites; approximately 30% excreted in urine and 70% in feces within 24 hours. |
| Half-life | Terminal half-life of carboprost (free acid) is approximately 8 minutes; the active metabolite 15-keto-13,14-dihydro-PGF2α has a half-life of about 30 minutes. Clinical context: rapid clearance requires continuous intramuscular administration or repeated dosing for sustained uterotonic effect. |
| Protein binding | Approximately 80% bound to plasma albumin. |
| Volume of Distribution | 0.5-1.0 L/kg; indicates extensive distribution into tissues. |
| Bioavailability | Intramuscular injection: essentially 100% (complete absorption). Oral: as carboprost tromethamine, bioavailability is approximately 20% due to first-pass metabolism; not used orally for this indication. Intra-amniotic: systemic absorption is slow and variable. |
| Onset of Action | Intramuscular administration: onset of uterine contraction within 2-5 minutes; intravenous or intra-amniotic routes produce more rapid onset (within 1-2 minutes). |
| Duration of Action | Uterotonic effect lasts approximately 2 hours following intramuscular injection; clinical monitoring for uterine hyperstimulation required. Duration may vary with dose and route. |
250 mcg (0.25 mg) intramuscularly every 1.5-3.5 hours, titrated to response; maximum 8 doses. For abortion, 250 mcg every 2 hours for up to 8 doses.
| Dosage form | INJECTABLE |
| Renal impairment | No specific dose adjustment required; however, use with caution in patients with renal impairment due to potential for elevated blood pressure and fluid retention. |
| Liver impairment | Contraindicated in patients with significant hepatic disease; avoid use in Child-Pugh class B or C. |
| Pediatric use | Not indicated for pediatric use; safety and efficacy not established. |
| Geriatric use | Use with caution due to increased risk of cardiovascular events; consider lower initial doses and monitor closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HEMABATE (HEMABATE).
| Breastfeeding | Not excreted into breast milk in significant amounts; M/P ratio unknown. Use with caution only when clearly needed, as oxytocics may cause uterine hyperstimulation and harm to the infant if transferred. |
| Teratogenic Risk | Pregnancy Category X. First trimester: Avoid use due to risk of fetal malformations. Second and third trimesters: Indicated only for postpartum hemorrhage after delivery; use during pregnancy for abortion induction causes fetal death. |
| Fetal Monitoring |
■ FDA Black Box Warning
HEMABATE should be used only by trained medical personnel in a hospital setting due to risk of serious reactions including hypertension, bronchospasm, and anaphylaxis.
| Serious Effects |
["Hypersensitivity to carboprost tromethamine or any component","Acute pelvic inflammatory disease","Active cardiac, pulmonary, renal, or hepatic disease"]
| Precautions | ["Hypotension or hypertension","Bronchospasm, especially in asthmatics","Fever and chills","Nausea, vomiting, diarrhea","Uterine rupture (rare)","Anaphylactic reactions"] |
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| Monitor uterine contractility, fetal heart rate, and maternal vital signs (blood pressure, heart rate) during administration. Watch for signs of excessive uterine stimulation (hypertonus, tetany), uterine rupture, or water intoxication. |
| Fertility Effects | No known direct effects on fertility. Potential indirect effects from uterine contractions and prostaglandin activity may theoretically interfere with implantation or early pregnancy viability if used inadvertently before pregnancy recognition. |