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    / Janssen


    Active Ingredient
    Domperidone 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 10 mg

    full basket chart 20473 13036

    Related information


    Dosage

    This product should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting. It is recommended to take oral tablet before meals. If taken after meals, absorption of the drug is somewhat delayed. Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose. Usually, the maximum treatment duration should not exceed one week. Adults, and adolescents (12 years of age and older and weighing 35 kg or more) one 10 mg tablet up to three times per day, with a maximum dose of 30 mg per day. Neonates, infants, children (less than 12 years of age) and adolescents weighing less than 35 kg – Due to the need for accurate dosing, Film-coated tablets, are unsuitable for use in children and adolescents weighing less than 35 kg.
    Hepatic impairment: This product is contraindicated in moderate or severe hepatic impairment. Dose modification in mild hepatic impairment is however not needed.
    Renal impairment: Since the elimination half-life of domperidone is prolonged in severe renal impairment, 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.
    For full details see prescribing information.


    Indications

    For the relief of the symptoms of nausea and vomiting.


    Contra-Indications

    Known hypersensitivity to domperidone or any of the excipients. Prolactin-releasing pituitary tumor (prolactinoma). When stimulation of gastric motility could be harmful, e.g. in the presence of gastro-intestinal hemorrhage, mechanical obstruction or perforation. In patients with moderate or severe hepatic impairment in patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure co-administration with QT-prolonging drugs co-administration with potent CYP3A4 inhibitors (regardless of their QT-prolonging effects).        


    Special Precautions

    Renal impairment: Since the elimination half-life of domperidone is prolonged in severe renal impairment, 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.
    Cardiovascular effects: Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing 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. Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death. 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. Domperidone should be used at the lowest effective dose in adults and children. Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia.
    Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are know to be conditions increasing the proarrythmic risk. Treatment with domperidone should be stopped if signs or symptoms occur that may be associated with cardiac arrhythmia, and the patients should consult their physician.Patients should be advised to promptly report any cardiac symptoms.
    Paediatric population: Although neurological side effects are 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. Therefore, it is recommended that the dose be determined accurately and strictly followed in neonates, infants and children. Due to the need for accurate dosing, tablets are unsuitable for use in children and adolescents weighing less than 35 kg. Overdosing may cause extrapyramidal disorders in children, but other causes should be taken into consideration.
    Lactose: The film-coated tablets contain lactose and may be unsuitable for patients with lactose intolerance, galactosemia or glucose/galactose malabsorption.


    Side Effects

    Common: Dry mouth.
    For full details see prescribing information.


    Drug interactions

    When antacids or antisecretory drugs are used concomitantly, they should not be taken simultaneously with oral formulations of domperidone base, i.e., they should be taken after meals and not before meals. The main metabolic pathway of domperidone is through CYP3A4. In vitro data suggest that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of domperidone. Increased risk of occurrence of QT interval prolongation, due to pharmacodynamic and/or pharmacokinetic interactions.
    Concomitant use of the the following substances is contraindicated: QTc-prolonging medicinal products:  anti-arrhythmics class IA (e.g., disopyramide, hydroquinidine, quinidine) anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol), certain antipsychotics (e.g., haloperidol, pimozide, sertindole), certain antidepressants (e.g., citalopram, escitalopram), certain antibiotics (e.g., erythromycin, levofloxacin, moxifloxacin, spiramycin), certain antifungal agents (e.g., pentamidine), certain antimalarial agents (in particular halofantrine, lumefantrine), certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride), certain antihistaminics (e.g., mequitazine, mizolastine), certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine), certain other medicines (e.g., bepridil, diphemanil, methadone), Potent CYP3A4 inhibitors (regardless of their QT-prolonging effects), i.e.: protease inhibitors systemic azole antifungals some macrolides (erythromycin, clarithromycin, telithromycin).
    Concomitant use of the following substances is not recommended: Moderate CYP3A4 inhibitors i.e., diltiazem, verapamil and some macrolides.
    Concomitant use of the following substances requires caution with use: Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor). The above list of substances is representative and not exhaustive.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: There are limited post-marketing data on the use of domperidone in pregnant women. This product should only be used during pregnancy when justified by the anticipated therapeutic benefit.
    Lactation: Domperidone is excreted in human milk and breast-fed infants receive less than 0.1% of the maternal weight-adjusted dose. Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from domperidone therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Caution should be exercised in case of QTc-prolongation risk factors in breast-fed infants.
    For full details see prescribing information.


    Overdose

    Symptoms: Overdose has been reported primarily in infants and children. Symptoms of overdose may include agitation, altered consciousness, convulsion, disorientation somnolence and extrapyramidal reactions.
    Treatment: There is no specific antidote to domperidone. In the event of overdose, standard symptomatic treatment should be given immediately. ECG monitoring should be undertaken, because of the possibility of QTc interval prolongation. Gastric lavage as well as the administration of activated charcoal may be useful. Close medical supervision and supportive therapy is recommended. Anticholinergic or anti-Parkinson drugs may be helpful in controlling the extrapyramidal disorder.


    Important notes

    Storage: Store between 15 and 30°C.


    Manufacturer
    Janssen Cilag SA – Val de Reuil, France
    Licence holder
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