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Cardiovascular Effects: Domperidone has been associated with prolongation of the QT interval. During postmarketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors.
Domperidone should be used with caution in older patients or those with current or history of cardiac disease. An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in some epidemiology studies. 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.
Treatment with domperidone should be discontinued if signs or symptoms occur that may be associated with cardiac arrhythmia. Patients should be advised to promptly report any cardiac symptoms to their physician.
Concomitant Use with Antacids or Secretory Agents: Antacids or antisecretory agents should not be taken simultaneously with domperidone since they lower the oral bioavailability of domperidone. When used concomitantly, domperidone should be taken before meals and antacids or antisecretory agents after meals.
Prolactin Levels: Domperidone produces an increase in plasma prolactin which persists with chronic administration but falls to normal upon discontinuation of the drug. During chronic oral administration of 30 mg daily for two weeks, the plasma prolactin level measured 90 minutes after medicine intake remained fairly constant at 25 ng/mL in males (normal value was 5 ng/mL), while in females, the level of 117 ng/mL after the first dose decreased to 56 ng/mL after 14 doses (pretreatment normal value was 9 ng/mL).
Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the administration of domperidone is contemplated in a patient with a past history of breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have been reported with other prolactin-elevating medicines, the clinical significance of elevated serum prolactin levels is unknown. An increase in mammary neoplasms has been found in rodents after chronic administration of domperidone and other prolactin-stimulating medicines. Neither clinical studies nor epidemiological studies have shown an association between chronic administration of these medicines and mammary tumorigenesis. Domperidone does not affect plasma growth hormone or aldosterone levels.
Lactose Intolerance: This medicine contains lactose as one of its excipients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Use in Children: Domperidone tablets are unsuitable for use in children weighing less than 35 kg. Although rare, the risk of neurological side effects is higher in young children since metabolic functions and the blood-brain barrier are not fully developed in the first months of life.
Use in the Elderly: No special precautions are necessary in older patients.
