Information to healthcare professionals

In order to minimise the risks of neurological and other adverse reactions, metoclopramide should only be prescribed for short-term use (up to 5 days).
It should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures.

In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapy-induced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).

In children, metoclopramide should only be used as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV. Use is contra-indicated in children under 1 year of age.

For adults and children the maximum dose in 24 hours is 0.5 mg per kg body weight;
in adults, the usual dose of conventional formulations (all routes) is 10 mg up to 3 times daily.

In children the recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily. A dosing table for use in children will be included in the product information.
Oral liquid formulations have been particularly associated with overdose in children.
Oral liquids containing more than 1 mg/ml will be withdrawn from the market, and oral doses of remaining formulations should be administered using an appropriately designed graduated oral syringe to ensure accuracy.

Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.

Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.

Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.

Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.

EUROPEAN MEDICINE REGULATORY AGENCY. JULY 2013.

G.Mohan.