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DOMPERIDONE is a brand name for Domperidone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
4 Drug-Drug Interactions). Patients at a higher risk of QT interval prolongation and/or cardiac arrhythmia should be considered for cardiac assessment including Electrogastrographic (EGG) before initiation of domperidone therapy and during the treatment.
______________________________________________________________________________ DOMPERIDONE (Domperidone Tablets) Page 6 of 35 • 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 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). • Domperidone 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 dose > 30 mg.
(see 2 CONTRAINDICATIONS and 3 SERIOUS WARNINGS AND PRECAUTIONS BOX) Patient 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 adminstration, 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 Domperidone maleate is contraindicated in patients with moderate to severe hepatic impairment (see 2 CONTRAINDICATIONS). Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use.
4 Administration 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. ______________________________________________________________________________ DOMPERIDONE (Domperidone Tablets) Page 7 of 35 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 (arrythmia, hypotension) might possibly occur.
Treatment Anticholinergic, anti-parkinsonian drugs or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. There is no specific antidote to domperidone but in the event of overdosage, gastric lavage as well as the administration of activated charcoal may be useful.
2 Breast-feeding 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1. INDICATIONS ............................................................................................................... 1 Pediatrics ...........................................................................................................................
2 Geriatrics ........................................................................................................................... 4 2. CONTRAINDICATIONS ..................................................................................................
4 3. SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4. DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .......................................................................................................
2 Recommended Dose and Dosage Adjustment .................................................................. 4 Administration ...................................................................................................................
5 Missed Dose....................................................................................................................... 6 5. OVERDOSAGE ..............................................................................................................
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 dose > 30 mg.
(see 2 CONTRAINDICATIONS;
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Domperidone in Canada.
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Close observation including ECG monitoring and supportive therapy are recommended. For management of a suspected drug overdose, contact your regional poison control centre. 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients oral tablet 10 mg of domperidone maleate Cornstarch, croscarmelose sodium, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium docusate 85%- sodium benzoate 15% and, titanium dioxide, triacetin.
73 mg of domperidone maleate equivalent to 10 mg of domperidone and available in bottles of 500 tablets. 7. WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. ______________________________________________________________________________ DOMPERIDONE (Domperidone Tablets) Page 8 of 35 Carcinogenesis and Mutagenesis See 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity.
Cardiovascular In an interaction study, when domperidone was administered with ketoconazole, an increase in the QT interval was observed. 4 Drug-Drug Interactions). Co-administration of ketoconazole with domperidone is contraindicated.
, twice the maximum recommended daily therapeutic dose. It is noteworthy that cardiac arrhythmia and death were reported following very high parenteral doses of domperidone. These results should be considered when domperidone is prescribed with other CYP3A4 inhibitors because they may increase plasma levels of domperidone.
4 Drug-Drug Interactions). Concomitant use of domperidone with moderate CYP3A4 inhibitors such as diltiazem, verapamil and some macrolides is not recommended. Co-administration with QT prolonging drugs (see list below*) is contraindicated (see 2 CONTRAINDICATIONS).
, erythromycin, levofloxacin, moxifloxacin, spiramycin), • […]
7 6. DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING................................... 7 7. WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations ..........................................................................................................
1 Pregnant Women ......................................................................................................... 2 Breast-feeding ..............................................................................................................
3 Pediatrics ...................................................................................................................... 4 Geriatrics ......................................................................................................................
10 8. ADVERSE REACTIONS .................................................................................................. 1 Adverse Reaction Overview.............................................................................................
2 Clinical Trial Adverse Reactions ....................................................................................... 3 Less Common Clinical Trial Adverse Reactions ...............................................................
12 9. 14 10. 16 11. 17 12. 18 13. 18 14. 18 15. […]