Overview
Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is an analogue of oxytocin, and its action is similar to that of oxytocin -- it causes contraction of the uterus.
Indication
Used to control postpartum hemorrhage and bleeding after giving birth.
Associated Conditions
- Postpartum Haemorrhage (PPH)
- Uterine Atony
Research Report
Carbetocin: A Comprehensive Pharmacological and Clinical Monograph
Introduction
Carbetocin is a long-acting, synthetic nonapeptide analogue of the endogenous human hormone oxytocin, engineered to possess enhanced stability and a prolonged duration of action.[1] It has established a prominent position in modern obstetric practice as a critical uterotonic agent, a class of drugs that stimulates contraction of the myometrium.[1] The principal clinical indication for Carbetocin is the prevention of postpartum hemorrhage (PPH), a life-threatening complication of childbirth characterized by excessive bleeding.[5] Its use is particularly well-established following Cesarean section and is increasingly supported for the prevention of PPH after vaginal delivery.[8]
The primary pharmacological distinction and clinical advantage of Carbetocin over oxytocin, the conventional first-line uterotonic, lies in its significantly longer biological half-life and duration of action.[10] This superior pharmacokinetic profile, a direct result of specific structural modifications to the oxytocin peptide, allows for effective uterine tone to be achieved and maintained with a single bolus injection. This contrasts sharply with the short half-life of oxytocin, which often necessitates a prolonged intravenous infusion to prevent uterine atony, the most common cause of PPH.[10]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/27 | Phase 4 | Not yet recruiting | Jordan Leitch | ||
2025/04/16 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2024/11/18 | N/A | Completed | |||
2024/05/20 | Phase 3 | ENROLLING_BY_INVITATION | |||
2024/03/27 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2024/02/29 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2024/01/22 | Phase 1 | Completed | |||
2023/12/15 | Phase 3 | Active, not recruiting | |||
2023/12/07 | N/A | Completed | Ministry of Health and Population, Egypt | ||
2023/08/14 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DURATOCIN RTS SOLUTION FOR INJECTION 100 MCG/ML | SIN15173P | INJECTION, SOLUTION | 100 mcg/ml | 2/8/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
CARBETOCIN INTERPHARMA Carbetocin 100 microgram/1 mL Solution for IV injection in pre-filled syringe | 305583 | Medicine | A | 6/27/2019 | |
DURATOCIN carbetocin 100 microgram/mL injection vial | 233671 | Medicine | A | 4/17/2015 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DURATOCIN | Ferring Inc | 02231593 | Solution - Intravenous | 100 MCG / ML | 8/1/1999 |
DURATOCIN | Ferring Inc | 02496526 | Solution - Intramuscular
,
Intravenous | 100 MCG / ML | 8/5/2020 |
CARBETOCIN INJECTION | Juno Pharmaceuticals Corp. | 02489244 | Solution - Intravenous | 100 MCG / ML | 1/21/2020 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
CARBETOCINA GP-PHARM 100 MICROGRAMOS SOLUCION INYECTABLE EN JERINGA PRECARGADA | Gp Pharm S.A. | 79228 | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Uso Hospitalario | Commercialized |
DURATOBAL 100 microgramos/ml SOLUCION INYECTABLE | Ferring S.A. | 68550 | SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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