4 Drug-Drug Interactions). , gastrointestinal hemorrhage, mechanical obstruction or perforation. • Patients with a prolactin-releasing pituitory tumour (prolactinoma). 5 Post-Market Adverse Reactions). The risk may be higher in patients older than 60 years or in patients taking a daily dose of more than 30 mg.
4 Drug-Drug Interactions). Domperidone should be used at the lowest possible dose for the shortest duration necessary. One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily doses> 30 mg.
4 Drug-Drug Interactions). Patients at a higher risk of QT interval prolongation and/or cardiac arrhythmia should be considered for cardiac assessment including ECG before initiation of domperidone therapy and during the treatment. 1 Dosing Considerations Important considerations: • The expected benefit of an increased dose should out weight the potential risks.
• Recent post-market epidemiological studies and review of post-market safety data have shown that the risk of serious ventricular arrhythmias or sudden cardiac death may be JAMP Domperidone Tablets (Domperidone Tablets) Page 6 of 37 higher in patients older than 60 years of age or in patients taking a daily dose of more than 30 mg.
4 Drug-Drug Interactions). • JAMP Domperidone Tablets should be used at the lowest possible dose for the shortest duration necessary. 2 Recommended Dose and Dosage Adjustment One 10 mg tablet three times per day with a maximum dose of 30 mg per day is recommended for all indications as the risk of serious cardiac events may be increased in association with daily doses> 30 mg (see 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX).
Patients with renal impairment Since very little unchanged drug is excreted via the kidneys, it is unlikely that a single administration needs to be adjusted in patients with renal insufficiency. However, on repeated administration, the dosing frequency should be reduced to once or twice daily, depending on the severity of the impairment, and the dose may need to be reduced.
Generally, patients on prolonged therapy should be reviewed regularly (see 7 WARNINGS AND PRECAUTIONS, Renal). Patients with hepatic impairment JAMP Domperidone Tablets (domperidone maleate) is contraindicated in patients with moderate or severe liver impairment (see 2 CONTRAINDICATIONS).
Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use. 4 Administration JAMP Domperidone Tablets are for oral administration and should be taken 15 to 30 minutes before the meals. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember.
If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for the forgotten dose. JAMP Domperidone Tablets (Domperidone Tablets) Page 7 of 37 5 OVERDOSAGE Symptoms Based on the pharmacological properties of domperidone, symptoms of overdosage may include CNS effects (such as drowsiness, disorientation and extrapyramidal reactions, especially in children) and cardiovascular effects (arrhythmia, hypotension) might possibly occur.