Schedule H

Intravenous (IV), Intramuscular (IM)

• Injection: 100 micrograms/mL (1 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Prevention of Uterine Atony and Postpartum Haemorrhage (PPH) Following Caesarean Section Under Regional Anaesthesia

Step Dose Clinical Notes

Starting dose 100 micrograms (1 mL) IV bolus Administer slowly over 1 minute immediately after delivery of infant

Titration Not applicable Single-dose regimen

Usual maintenance dose Not applicable No repeat dosing required due to prolonged duration of action

Maximum dose 100 micrograms (single dose only) Do not repeat; no additional dose indicated

Key points:

• Administer only after delivery of the baby — NEVER before delivery

• Longer duration of action (~60 minutes) compared to oxytocin (~15–30 minutes)

• Not indicated for treatment of established PPH — use oxytocin or other uterotonics

• Cold chain storage required (2–8°C) for standard formulation

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Prevention of PPH after vaginal delivery 100 micrograms IM immediately after delivery of anterior shoulder or placenta Single dose OFF-LABEL in India; Specialist only; Evidence: WHO recommendation as alternative to oxytocin; CHAMPION trial (Lancet 2018); Cochrane meta-analysis supports equivalence to oxytocin

Note: Heat-stable carbetocin formulation (not requiring cold chain) has WHO recommendation for vaginal delivery PPH prevention but availability in India is limited; verify cold chain capability before use

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable. Carbetocin is not indicated in paediatric patients. Use is exclusively restricted to postpartum women following delivery.

Secondary Indications — Paediatrics (Off-label)

Not applicable.

Mild-moderate impairment No specific data available; use with caution

Severe impairment (eGFR <30) Avoid use unless benefit clearly outweighs risk; specialist supervision required

Dialysis No data available; not expected to be dialysable (peptide structure)

Note: Limited pharmacokinetic data in renal impairment; carbetocin is a peptide hormone with primarily hepatic metabolism

• Use during pregnancy before delivery of the infant (induces uterine contractions — risk of uterine rupture and fetal distress)

• Use during labour or for induction/augmentation of labour

• Known hypersensitivity to carbetocin, oxytocin, or any excipient

• Severe pre-eclampsia or eclampsia

• Serious cardiovascular disorders (severe hypertension, cardiac disease with haemodynamic instability)

• Severe hepatic or renal impairment

• Epilepsy (uncontrolled)

• Mild-to-moderate hypertension or pre-eclampsia — monitor blood pressure closely

• Cardiac disease (mild-moderate) — risk of hypotension and cardiovascular effects

• History of migraine — may exacerbate

• Asthma — potential mild bronchoconstrictive effect (theoretical)

• Multiple pregnancy or polyhydramnios — assess uterine response

• Concurrent use with other uterotonics — avoid unless necessary for refractory atony

• Temperature-sensitive drug — verify cold chain integrity before administration

Parameter Recommendation

Safety category Used exclusively after delivery of the infant; contraindicated during pregnancy and labour

Preferred alternatives Not applicable — carbetocin is itself an alternative to oxytocin for PPH prophylaxis

When it may be used Immediately after delivery for prevention of uterine atony and PPH following caesarean section

Monitoring Maternal: blood pressure, heart rate, uterine tone, vaginal bleeding; fetal monitoring not applicable (postpartum use only)

Note: Carbetocin must NEVER be administered before delivery of the infant — causes tetanic uterine contraction risking uterine rupture and fetal death

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Negligible (peptide hormone — minimal oral bioavailability in infant even if present)

Preferred alternatives Not applicable — carbetocin is used as single postpartum dose

Infant monitoring No specific monitoring required; theoretical possibility of delayed lactogenesis onset — monitor milk production and breastfeeding initiation

Not applicable. Carbetocin is used exclusively in postpartum women; not indicated in elderly population.

Drug Interaction Management

Ergot alkaloids (ergometrine, methylergometrine) Additive uterotonic effect + synergistic vasoconstriction → severe hypertension, coronary vasospasm, stroke risk AVOID concurrent use; if sequential use essential for refractory atony, allow adequate interval and monitor BP closely

Prostaglandins (misoprostol, carboprost, dinoprostone) Synergistic uterotonic effect → risk of uterine hyperstimulation, tetanic contraction, uterine rupture AVOID concurrent use; if sequential use for refractory PPH, use with extreme caution under specialist supervision

Other oxytocic agents Additive effects; increased risk of uterine hyperstimulation Avoid combination; carbetocin's long duration reduces need for additional uterotonics

Drug Interaction Management

Inhalational anaesthetics (halothane, sevoflurane, isoflurane) May attenuate uterotonic effect of carbetocin Monitor uterine tone closely; may need to assess uterine response

Spinal/epidural anaesthesia Additive hypotensive effect Monitor blood pressure; administer carbetocin slowly

Vasopressors (ephedrine, phenylephrine) Additive cardiovascular effects Use lowest effective doses; monitor blood pressure

• Nausea and vomiting

• Abdominal pain / cramping

• Flushing

• Headache

• Tremor

• Hypotension

• Sensation of warmth

• Pruritus

• Metallic taste

Reaction Action Required

Uterine hyperstimulation / Tetanic contraction Should not occur with proper single-dose use; if occurs (usually with oxytocic combination), discontinue any ongoing infusions; supportive care

Uterine rupture Surgical emergency; immediate laparotomy

Severe hypotension Stop administration if ongoing; IV fluids; vasopressors if required

Bradycardia / Cardiac arrhythmia Supportive care; cardiology input if persistent

Anaphylaxis / Severe allergic reaction Discontinue immediately; standard anaphylaxis management

Chest pain / Myocardial ischaemia Discontinue; ECG; cardiology review

Immediately after administration Blood pressure and heart rate (may cause transient hypotension); observe for allergic reaction

First 1–2 hours post-administration Uterine tone (fundal assessment); vaginal bleeding; maternal vital signs every 15–30 minutes

Before discharge Confirm uterine involution; no excessive bleeding; breastfeeding initiation

Note: No laboratory monitoring required for single-dose use

Single-ingredient products:

• Duratocin (Ferring Pharmaceuticals) — most widely available

• Pabal (Ferring — alternate brand name)

• Carbitocin (generic — limited availability)

Note: Heat-stable carbetocin formulation is available internationally but verify current availability in India

NLEM status: Not included in NLEM 2022 — not under NPPA price ceiling

Storage: Requires cold chain (2–8°C); standard formulation loses potency if exposed to heat

• Single-dose advantage: Long duration of action (~60 minutes) eliminates need for IV infusion or repeat dosing — reduces dosing errors and nursing workload compared to oxytocin

• Cold chain critical: Standard carbetocin requires refrigeration (2–8°C); verify cold chain integrity before use; heat-stable formulation not widely available in India yet

• Not for PPH treatment: Carbetocin is for prevention only; if PPH occurs despite carbetocin, treat with oxytocin infusion, ergometrine (if not contraindicated), carboprost, or misoprostol as per protocol

• Caesarean section preference: Primary indication is PPH prevention following elective caesarean under regional anaesthesia; vaginal delivery use is emerging but currently off-label in India

• Cost consideration: Significantly more expensive than oxytocin; reserve for settings where advantages (single dose, no infusion pump needed, longer action) justify cost

• Never before delivery: Absolute contraindication to administer before infant delivery — causes tetanic uterine contraction with catastrophic consequences

carbetocin; uterotonic; PPH prevention; caesarean section; oxytocin analogue; single-dose; cold-chain; postpartum; not-for-treatment; not-NLEM

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• AIIMS Obstetrics Protocols

• FOGSI Guidelines on Management of PPH

• MoHFW Guidelines on Prevention of PPH

• WHO Recommendations on Uterotonics for Prevention of PPH (2018 update)

• CHAMPION Trial (Lancet 2018) — for off-label vaginal delivery indication

• Cochrane Review: Carbetocin versus oxytocin for preventing postpartum haemorrhage