Duratocin RTS Special Precautions

Carbetocin is intended for use only at well-equipped specialist obstetrics units with experienced and qualified staff available at all times.
The use of carbetocin at any stage before delivery of the infant is not appropriate because its uterotonic activity persists for several hours. This is in marked contrast to the rapid reduction of effect observed after discontinuation of an oxytocin infusion.
Carbetocin is intended for single administration only, intramuscular or intravenous. In case of intravenous administration, it must be administered slowly over 1 minute. In case of persisting uterine hypotonia or atonia and the consequent excessive bleeding, additional therapy with another uterotonic should be considered. There are no data on additional doses of carbetocin or on the use of carbetocin following persisting uterine atony after oxytocin.
In general, carbetocin should be used cautiously in the presence of epilepsy, migraine, asthma and cardiovascular disease or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system. The decision of administering carbetocin can be made by the physician after carefully weighing the potential benefit carbetocin may provide in these particular cases. No data is available on the use of carbetocin in patients with eclampsia. Patients with eclampsia and pre-eclampsia should be carefully monitored.
Animal studies have shown carbetocin to possess some antidiuretic activity (vasopressin activity: <0.025 IU/vial) and therefore the possibility of hyponatraemia cannot be excluded, particularly in patients also receiving large volumes of intravenous fluids. The early signs of drowsiness, listlessness and headache should be recognised to prevent convulsions and coma.
Specific studies have not been undertaken in gestational diabetes mellitus.
Effects on ability to drive and use machines: Not relevant.