Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
The active management of the third stage of labour (as a means to promote separation of the placenta and to reduce blood loss), or routinely, following the birth of the placenta, to prevent or treat postpartum haemorrhage.
Syntometrine should be used under medical supervision only.
Active management of third stage of labour: Intramuscular injection of 1ml after delivery of the anterior shoulder, or at the latest, immediately after delivery of the child. Expulsion of the placenta, which is normally separated by the first strong uterine contraction, should be assisted by controlled cord traction.
Prevention and treatment of postpartum haemorrhage: Intramuscular injection of 1ml following expulsion of the placenta, or when bleeding occurs.
No studies have been performed in patients with renal or hepatic impairment. However considering the metabolic pathway of ergometrine and oxytocin, use is contraindicated in severe hepatic and renal impairment and caution is required in mild or moderate hepatic and renal impairment (see sections 4.3 Contraindications, 4.4 Special warnings and precautions for use and 5.2 Pharmacokinetic properties).
No data are available.
Not applicable.
Intramuscular injection is the recommended route.
Intravenous administration of Syntometrine (0.5 to 1 mL by slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.
In the event of maternal intoxication the most likely symptoms would be those of ergometrine intoxication: nausea, vomiting, hypertension or hypotension, vasospastic reactions, respiratory depression, convulsions, coma.
In cases of oral ingestion, although the benefit of gastric decontamination is uncertain, activated charcoal may be given to patients who present within 1 hour of ingesting a toxic dose (more than 125 micrograms/kg in adults) or any amount in a child or in adults with peripheral vascular disease, ischaemic heart disease, severe infection, or hepatic or renal impairment. Alternatively, gastric lavage may be considered in adults within 1 hour of ingesting a potentially life-threatening overdose.
In both acute and chronic poisoning by all routes, attempts must be made to maintain an adequate circulation to the affected parts of the body in order to prevent the onset of gangrene. In severe arterial vasospasm, vasodilators such as sodium nitroprusside by intravenous infusion have been given; heparin and dextran 40 have also been advocated to minimise the risk of thrombosis. Analgesics may be required for severe ischaemic pain.
Accidental administration to the newborn infant has been reported and has proved fatal. In these accidental neonatal overdosage cases, symptoms such as respiratory depression, convulsions, cyanosis, oliguria, hypertonia and heart arrhythmia have been reported. Treatment has been symptomatic in most cases; respiratory and cardiovascular support have been required.
3 years.
For prolonged periods store between 2° and 8°C. Protect from light. Syntometrine may be stored up to 25°C for 2 months when protected from light, but must then be discarded.
Uncoloured borosilicate glass Type I snap ampoule. Packs of 5 ampoules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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