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ATC codes: G02AB03
Indication
Postpartum haemorrhage ICD11 code: JA43.Z
INN
Ergometrine
Medicine type
Chemical agent
List type
Core
Formulations
Parenteral > General injections > unspecified: 200 µg in 1 mL ampoule (hydrogen maleate)
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 2005 (TRS 933)
Sex
Female
Age
Adolescents and adults
Therapeutic equivalence
Medicines within the same pharmacological class can be used
Patent information
Patents have expired in most jurisdictions
Summary of evidence and Expert Committee recommendations
During its meeting in 2003, the Committee recommended that ergometrine be reviewed for possible fast-track deletion at the meeting in 2005. Comments were received from the WHO Department of Reproductive Health and Research. A review of the evidence found that there was no robust clinical evidence to establish the effectiveness and safety of ergometrine used alone for active management of labour. A Cochrane review (1) of trials of oxytocin alone showed that it reduced postpartum haemorrhage, and that the combination of ergometrine with oxytocin was slightly superior for this outcome. Maternal side-effects were more frequent in women treated with the combination regimen. There was no clinical trial evidence to support the efficacy and safety of ergometrine used alone or in combination with oxytocin for the treatment of postpartum haemorrhage. The Committee recommended that ergometrine injection for the treatment of acute postpartum haemorrhage be retained on the Model List, mainly due to the potential benefits offered by its different pharmacological action (tonic versus periodic contractions that occur with oxytocin). The Committee also recommended that more clinical studies be performed in this area. The Committee saw no indication for ergometrine tablets and recommended that these be deleted from the Model List. 1. 15. McDonald S. Abbot JM, Higgins SP. Prophylactic ergometrine-oxytocin versus oxytocin for the third stage of labour (Cochrane Review). In Cochrane Library, issue 2. Chichester, John Wiley & Sons, 2005 (http://www.cochrane.org/cochrane/revabstr/AB000201.htm).