NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Medicines
Medicines Update

Safety Update: Domperidone (July 2014)

The MHRA has recently recommended changes to the use of domperidone, including restricting the dose and duration of use, to minimise the known risks of potentially serious cardiac adverse effects.

 

There are now no drugs on the UK market licensed as prokinetic agents. Metoclopramide has also recently had restrictions placed on its use due to extrapyramidal adverse effects. It should only be used short-term (up to 5 days) and should not be used in chronic conditions such as gastroparesis, dyspepsia and GORD, nor as an adjunct in surgical and radiological procedures.

 

  • Domperidone is now only licensed for nausea and vomiting.
  • Domperidone should be used at the lowest effective dose for the shortest possible duration. The maximum treatment duration should not usually exceed one week.
  • The new recommended dose in adults (and adolescents ≥ 35kg where licensed) is 10mg orally up to three times daily (maximum dose of 30mg daily). Adults and adolescents weighing ≥ 35kg may be given 30mg twice daily rectally as suppositories.
  • In children under 12 years of age and less than 35kg, the recommended maximum oral dose is 0.25mg/kg body weight up to three times a day.
  • Domperidone is contraindicated in severe hepatic impairment, conditions where cardiac conduction is, or could be, impaired or where there is underlying cardiac disease, and when co-administered with QT-prolonging medicines or potent CYP3A4 inhibitors.

 

Advice on alternative management of patients with GORD / dyspepsia and gastroparesis has been produced by UKMI and is available at http://www.midlandsmedicines.nhs.uk/filestore/domperidone%20GI%20restrictions%20May%202014.pdf

 

Medicines for Children, a partnership of bodies including the Royal College of Paediatrics and Child Health and the Neonatal and Paediatric Pharmacists’ Group has information on use of domperidone in children at http://www.medicinesforchildren.org.uk/search-for-a-leaflet/domperidone-for-gastro-oesophageal-reflux/.

 

Practices have already been advised on appropriate timescales and mechanisms for managing this change.