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Gastrointestinal System

Domperidon STADA® 10 mg

 

Pack size:

Box of 10 blisters x 10 film-coated tablets.

 

Composition:

Each film-coated tablet contain domperidone (as domperidone maleate) 10 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Relief of the symptoms of nausea and vomiting.
     
  • Domperidon STADA® 10 mg should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
  • It is recommended to take oral Domperidon STADA® 10 mg 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.
  • Hepatic impairment:
    Domperidon STADA® 10 mg 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.


Or as prescribed by physicians.

 

  • Known hypersensitivity to any ingredient of the drug.
  • Prolactin­ - releasing pituitary tumour (prolactinoma).
  • When stimulation of the gastric motility could be harmful e.g. in patients with gastro­intestinal haemorrhage, mechanical obstruction or perforation.
  • Patients with moderate or severe hepatic impairment.
  • 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).

     

Uncommon

  • Breast pain.

Rare

  • Increased prolactin levels.
  • Gastro-intestinal disorders including very rare transient intestinal cramps.
  • Galactorrhoea, gynaecomastia, amenorrhoea.

Very rare

  • Allergic reaction, including anaphylaxis, anaphylactic shock, anaphylactic reaction and angiodema.
  • Agitation, nervousness.
  • Extrapyramidal side effects, convulsion, somnolence, headache.
  • Diarrhoea.
  • Urticaria, pruritus, rashes.
  • Liver function test abnormal.

Unknown

  • Dystonia, restless leg syndrome (Exacerbation of restless legs syndrome in patients with Parkinson's disease).
  • Oculogyric crisis.
  • Reduced libido.
  • Ventricular arrhythmias, QTc prolongation, torsade de pointes, sudden cardiac death.
  • As the hypophysis is outside the blood brain barrier, domperidone may cause an increase in prolactin levels. In rare cases this hyperprolactinaemia may lead to neuro-endocrinological side effects such as galactorrhoea, gynaecomastia and amenorrhoea. Extrapyramidal side effects are exceptional in adults. These side effects reverse spontaneously and completely as soon as treatment is stopped.

Paediatric population

  • Extrapyramidal disorders occur primarily in neonates and infants.
  • Other central nervous system-related effects of convulsion, agitation and somnolence are also very rare and primarily reported in infants and children.

Reporting adverse reactions

  • Reporting adverse reactions after authorisation of the medicinal product is important to continue monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any adverse reactions to The National/Regional Centre of Drug Information and Adverse Drug Reactions Monitoring.


 

  • Renal impairment:
    The elimination half­-life of domperidone is prolonged in severe renal impairment. For repeated administration, the dosing frequency of Domperidon STADA® 10 mg should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced.
  • Cardiovascular effects:
    Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. 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.
    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 known 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.
  • Domperidon STADA® 10 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose - galactose malabsorption should not take this medicine.
  • Pregnancy: The potential risk for humans is unknown. Therefore, domperidone 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.
  • Effects on ability to drive and use machines: Taking domperidone may cause extrapyramidal reactions or drowsiness with very rare incidence. In such cases, patients should not drive cars or use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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