Peculiarities of use of emetrol (domperidone)

Emetrol (domidone, domperidone) is used to relieve the symptoms of nausea and vomiting. But it is not recommended to use it for motion sickness. Domidone should be used with caution in elderly patients or patients with a history or history of heart disease.

Cardiovascular effects. Emetrol has been associated with prolongation of the QT interval on ECG. During the post-marketing follow-up, very rare cases of QT prolongation and ventricular flutter-fibrillation in patients taking domperidone have been recorded. These reports included information on patients with other adverse risk factors, electrolyte disturbances and concomitant therapy that may contribute to this condition.

Peculiarities of use of emetrol (domperidone)

Caution. Domperidone should be used with caution in patients with mild hepatic and/or renal impairment. Because of the increased risk of ventricular arrhythmia, Domidone is contraindicated in patients with prolonged intervals of cardiac conduction, particularly QTc, patients with significant electrolyte imbalance (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 or symptoms that may be associated with cardiac arrhythmia, the use of Domidon should be discontinued and the patient should immediately consult a physician.

Impaired renal function. The half-life of domperidone in severe renal impairment is prolonged. In long-term use, the dosage frequency of domperidone should be reduced to one or two times per day, depending on the severity of the impairment. It may also be necessary to reduce the dose.
Antacids or antisecretory drugs should not be taken concomitantly with oral forms of Domidone, since they reduce oral bioavailability of domperidone. When concomitant use, the drug Domidon should be taken before meals, and antacids or antisecretory drugs – after meals.

Domidon tablets contain lactose, therefore, the drug should not be used in patients with lactose intolerance, galactosemia and glucose/galactose malabsorption.

The following information about 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 serious ventricular arrhythmias or sudden cardiac death, the risk of serious ventricular arrhythmias or sudden cardiac death may be higher in patients older than 60 years or when using oral doses of the drug greater than 30 mg daily. Therefore, caution should be exercised when using Domidone in elderly patients. Patients over 60 years of age should consult a physician before taking Domidone, domperidone should be prescribed in adults and children in the lowest effective dose.

Use during pregnancy or lactation

Peculiarities of use of emetrol (domperidone)

Pregnancy. The data of postmarketing use of domperidone in pregnant women are limited. Therefore, Domidone during pregnancy should be prescribed only when, in the opinion of the physician, the expected beneficial effects for the mother exceed the potential risk to the fetus.

Breastfeeding. The amount of domperidone that may enter the infant’s body with breast milk is very 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 if it is harmful to the infant, so mothers taking Domidone 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 with breast milk, the occurrence of side effects, particularly cardiac effects, cannot be excluded.

Influence on the reaction rate when driving motor transport or operating other mechanisms

After using domperidone, dizziness and somnolence were observed. Therefore, patients should be advised to refrain from driving motor transport, operating other mechanisms or other activities that require concentration and coordination until they establish how Domidone affects them.