Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Hameln pharmaceuticals ltd, Gloucester, UK
Ergometrine Injection is used in the active management of the third stage of labour and in the treatment of post-partum haemorrhage. Ergometrine Injection may be given by intramuscular or intravenous injection.
Ergometrine Injection should be used under medical supervision only.
Ergometrine Injection is administered (often in combination with synthetic oxytocin 5 units) intramuscularly as a dose of 500 micrograms following the delivery of the anterior shoulder of the infant or at the latest immediately after delivery of the baby.
Doses of 200 micrograms to 500 micrograms of Ergometrine are given intramuscularly, following expulsion of the placenta or when bleeding occurs. In emergencies, Ergometrine Injection may be given intravenously at a dose of 250 micrograms to 500 micrograms.
No studies have been performed in patients with renal or hepatic impairment. However, considering the metabolic pathway of ergometrine, 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 Ergometrine Injection at a dose of 250 micrograms to 500 micrograms (by slow injection) is possible, but should be limited to use only in cases of severe haemorrhage due to uterine atony.
Symptoms of acute poisoning include nausea, vomiting, diarrhoea, extreme thirst, coldness, tingling and itching of the skin, tachycardia, vasospastic reactions, respiratory depression, confusion, convulsions and coma. Angina, hypertension or hypotension may also occur.
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 of ergometrine-containing medicinal products 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.
Shelf life: 36 months.
Ergometrine should be stored between 2°C and 8°C and protected from light.
1ml clear type I glass ampoules. Packed in cartons to contain 10 ampoules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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