Emetrol (domperidone) is not recommended to use in case of motion sickness. Emetrol should be used with caution in elderly patients or patients with existing heart disease or with a history of heart disease.
Cardiovascular effects. Domperidone has been associated with prolongation of the QT interval on ECG. During the post-marketing follow-up, very rare cases of QT prolongation and torsade de pointes ventricular fibrillation have been observed in patients taking domperidone. These reports included information on patients with other adverse risk factors, electrolyte disturbances and concomitant therapy that may be contributing factors.QT interval prolongation observed in healthy individuals when they used domperidone according to the recommended dosing regimen in the usual therapeutic doses (10 or 20 mg 4 times daily) had no clinical significance.
Emetrol (Domperidone) should be used with caution in patients with mild hepatic and/or renal dysfunction. Because of the increased risk of ventricular arrhythmia, the drug is not recommended for use in patients with prolonged intervals of cardiac conduction, particularly QTc, patients with significant electrolyte imbalances (hypokalemia, hyperkalemia, hypomagnesemia) or bradycardia, or patients with background heart disease, such as congestive heart failure. Electrolyte imbalances (hypokalemia, hyperkalemia, hypomagnesemia) and bradycardia are known to be conditions that increase proarrhythmogenic risk. In case of signs and symptoms that may be associated with cardiac arrhythmia, the use of the drug emetrol should be stopped, and the patient should immediately consult a physician.
Renal function impairment. The half-life of domperidone in severe renal impairment is prolonged. In long-term use, the dosing frequency of domperidone should be reduced to one or two times per day, depending on the severity of the impairment. Dose reduction may also be required.
Antacids or antisecretory drugs should not be taken simultaneously with the drug, since they reduce oral bioavailability of domperidone. When concomitant use, Domperidone should be taken before meals, and antacids or antisecretory drugs – after meals.
Administration with ketoconazole. In studies of interaction with oral form of ketoconazole, prolongation of the QT interval was observed. Although the significance of this study is not clearly established, alternative treatment should be chosen if antifungal therapy with ketoconazole is indicated. The following information regarding the risk of cardiovascular complications due to the medicinal products containing domperidone should be considered.
Some epidemiological studies have shown that domperidone may be associated with an increased risk of severe ventricular arrhythmias or sudden cardiac death.
The risk of severe ventricular arrhythmias or sudden cardiac death may be higher in patients aged over 60 years or when using oral doses of the drug more than 30 mg per day. Therefore, Domperidone should be used with caution in elderly patients. Patients over 60 years of age should consult their physician before taking the drug.
Domperidone should be administered in adults and children in the lowest effective dose. The risk/benefit ratio of domperidone use remains favorable. If you have intolerance to some sugars, consult your doctor before taking this medicinal product, as the drug contains lactose.
Use during pregnancy or lactation
There are limited data regarding the post-marketing use of domperidone in pregnant women. Therefore, Domperidone during pregnancy should be administered only when, in the opinion of the doctor, the expected positive effect for the mother exceeds the potential risk for the fetus. The amount of domperidone that can be absorbed by the infant through breast milk is extremely low. The maximum relative dose for infants (%) is estimated to be about 0.1% of the maternal dose, adjusted for body weight. It is not known whether it is harmful to the infant, so mothers who take Domperidone should refrain from breastfeeding. Caution should be exercised if there are risk factors for QTc interval prolongation in breastfed infants. After exposure due to penetration of the drug into the breast milk, the occurrence of side effects, particularly cardiac effects, cannot be excluded.