Indications and contraindications for the use of emetrol (domperidone)

emetrol

Emetrol (domidone, domperidone) is used to relieve symptoms of nausea and vomiting.

Contraindications

Domidone is contraindicated: patients with a known hypersensitivity to the drug or excipients; patients with prolactin-secreting pituitary tumor (prolactinoma); patients with severe or moderate hepatic and/or renal dysfunction; patients with known prolonged cardiac conduction intervals, particularly QTc, patients with significant electrolyte imbalance or background heart disease such as congestive heart failure; patients with liver failure if stimulation of gastric motility may be dangerous, such as gastrointestinal bleeding, mechanical obstruction or perforation; concomitant use of ketoconazole, erythromycin or other potent CYP3A4 inhibitors is contraindicated; concomitant use of drugs that prolong the QT interval, such as fluconazole, erythromycin, itraconazole, oral ketoconazole, posaconazole, ritonavir, saquinavir, telaprevir, voriconazole, clarithromycin, amiodarone, telithromycin is contraindicated.

Interaction with other medicinal products

Indications and contraindications for the use of emetrol (domperidone)

Anticholinergic drugs may neutralize the antidyspeptic effect of Domidon. Due to the pharmacodynamic and/or pharmacokinetic interactions, the risk of QT interval prolongation increases. Antacids and antisecretory drugs should not be taken simultaneously with Domidone, because they reduce its bioavailability after oral administration. Domperidone is metabolized mainly by CYP3A4. According to the in vitro studies, concomitant use of drugs that significantly inhibit this enzyme may increase the plasma level of domperidone. When using domperidone together with potent CYP3A4 inhibitors that may prolong the QT interval, clinically significant changes in the QT interval were observed. Therefore, concomitant use of domperidone with certain drugs is contraindicated.

Concomitant use of the following substances requires caution

Caution is required with the drugs causing bradycardia and hypokalemia, as well as with the following macrolides that may cause prolongation of the QT interval: azithromycin and roxithromycin (clarithromycin is contraindicated, as it is a potent CYP3A4 inhibitor). Caution should be exercised when using domperidone together with potent CYP3A4 inhibitors that have not caused QT interval prolongation, such as indinavir, and the patients should be watched carefully in case of signs or symptoms of adverse reactions.
The above list of active ingredients is representative but not exhaustive.

Emetrol can be combined with:

Indications and contraindications for the use of emetrol (domperidone)

Neuroleptics, the effects of which it enhances;
Dopaminergic agonists (bromocriptine, L-dopa) whose unwanted peripheral effects such as digestive disorders, nausea, vomiting are inhibited without neutralizing the main properties. In separate studies of in vivo pharmacokinetic/pharmacodynamic interaction with concomitant oral administration of ketoconazole or erythromycin in healthy volunteers, it was confirmed that these drugs significantly inhibit CYP3A4-mediated presystemic metabolism of domperidone. In concomitant use of domperidone 10 mg orally 4 times per day and ketoconazole 200 mg orally 2 times per day during the observation period there was observed prolongation of QTc interval by 9.8 ms on the average; individual values varied from 1.2 to 17.5 ms. Concomitant administration of domperidone 10 mg 4 times per day and erythromycin 500 mg orally 3 times per day during the period of observation the QTc interval was prolonged on the average by 9.9 ms, the interval of single values ranged from 1.6 to 14.3 ms. The equilibrium Cmax and AUC values of domperidone increased approximately threefold in each of these interaction studies. The effect of increased plasma concentrations of domperidone on the observed effect on QTc is unknown. In these studies, domperidone monotherapy (10 mg orally 4 times daily) prolonged the QTc interval by an average of 1.6 ms (ketoconazole study) and 2.5 ms (erythromycin study), while the use of ketoconazole alone (200 mg 2 times daily) or erythromycin (500 mg 3 times daily) resulted in an increase in the QTc interval by 3.8 and 4.9 ms during the observation period, respectively.

Theoretically, since Domidone has a prokinetic effect on the stomach, it may affect the absorption of oral medications that are used simultaneously, in particular on sustained release or enteric soluble dosage forms. However, in patients whose condition has already stabilized against the background of using digoxin or paracetamol, concomitant use of domperidone had no effect on the blood levels of these drugs.

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