Finished product reference

Carbetocin

Injection, Solution · Parenteral · 100 µg/1mL · 1 mL

List code
16416
Pharmacologic class
Uterotonic; long-acting oxytocin receptor agonist

What it is and how it works

Carbetocin is a synthetic analogue of oxytocin that binds to oxytocin receptors in uterine smooth muscle, producing rhythmic contractions and increased uterine tone. It has a longer duration of action than oxytocin after a single injection.

Indications

Prevention of uterine atony and postpartum haemorrhage following delivery of the infant, by caesarean section under epidural or spinal anaesthesia and, for heat-stable formulations, after vaginal birth.

Dosage and administration (summary)

Single dose of 100 micrograms by slow intravenous injection over 1 minute (or intramuscularly for some products), given as soon as possible after delivery of the infant, preferably before removal of the placenta.

Contraindications

Use during pregnancy or labour before delivery of the infant, including for induction or augmentation of labour; hepatic or renal disease; serious cardiovascular disorders; pre-eclampsia and eclampsia; epilepsy; hypersensitivity to carbetocin or oxytocin.

Warnings and precautions

Not to be repeated; if uterine atony persists, additional treatment with other uterotonics should be considered. Can cause hypotension, flushing, tachycardia and, rarely, myocardial ischaemia; use with caution in cardiovascular disease and migraine. Water intoxication and hyponatraemia are possible because of antidiuretic activity.

Pregnancy

Contraindicated before delivery of the infant.

Storage and supply

Refrigerated formulations: 2–8 °C, protected from light; heat-stable formulations: below 30 °C, do not freeze.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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