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• certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3). Caution should be exercised in case of QTc prolongation risk factor in breast-fed infants.Domperidone has no or negligible influence on the ability to drive or use machines.The safety of domperidone was evaluated in clinical trials and in postmarketing experience.

ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

A multicentre, double-blind, randomised, placebo-controlled, parallel-group, prospective study was conducted to evaluate the safety and efficacy of domperidone in 292 children with acute gastroenteritis aged 6 months to 12 years (median age 7 years). Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The plasma half life after a single oral dose is 7-9 hours in healthy subjects but is prolonged in patients with severe renal insufficiency.

Article date: May 2014. A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.Domperidone should be used at the lowest effective dose in adults and children.Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patient with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3). In these studies domperidone monotherapy at 10mg given orally four times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while Ketoconazole monotherapy (200mg twice daily) led to increases in QTc of 3.8 and 4.9 msec, respectively, over the observation period.There are limited post-marketing data on the use of domperidone in pregnant women. The clinical trials included 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GORD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. Domperidone is a dopamine antagonist with antiemetic properties.

diltiazem, verapamil and some macrolides.Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).The above list of substances is representative and not exhaustive. Please refer to the apomorphine SmPCTreatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patient should consult their physician.Patient should be advised to promptly report any cardiac symptoms.The main metabolic pathway of domperidone is through CYP3A4. Subjects with severe hepatic impairment were not studied. Domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose. It is written for patients and gives information about taking or using a medicine. Since metabolic functions and the blood-brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children.Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration. • anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol) • anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine) A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.The low absolute bioavailability of oral domperidone (approximately 15%) is due to an extensive first-pass metabolism in the gut wall and liver. Distribution studies with radiolabelled drug in animals have shown wide tissue distribution, but low brain concentration. Domperidone is no longer indicated for the relief of nausea and vomiting in children aged under 12 years or those weighing less than 35 kg. A side effect is an unwanted response to a medication when it is taken in normal doses. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9. In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.The unbound fraction is increased by 25%, and the terminal elimination half-life is prolonged from 15 to 23 hours. In domperidone users, especially in adults, extrapyramidal side effects are very rare, but domperidone promotes the release of prolactin from the pituitary. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors (see section 4.8).Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8). This site uses cookies. • Known hypersensitivity to domperidone or any of the excipients.

At a high, maternally toxic dose (more than 40 times the recommended human dose), teratogenic effects were seen in the rat.

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