Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Domperidone

Generic name
Domperidone
Brand name
ATC Code
A03FA03

Pharmacokinetics in children

Premature neonates:
Clearance (Cl/F) 0.92 l/h, volume of distribution (Vd/F) 0.405 litres.
 

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

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Dosages

Nausea and vomiting NOT caused by acute gastro-enteritis (not effective for vomiting with a cerebral origin)
  • Oral
    • 1 month up to 18 years and < 35 kg
      • 0.25 mg/kg/dose, as required, max. 3x daily. Max: 0.75 mg/kg/day.
    • 1 month up to 18 years and ≥ 35 kg
      • 10 mg/dose, as required, max. 3x daily. Max: 30 mg/day.
    • 1 month up to 18 years and < 35 kg
      [2] [13] [14] [16]
      • 0.25 mg/kg/dose, as required, max. 3x daily. Max: 0.75 mg/kg/day.
    • 1 month up to 18 years and ≥ 35 kg
      [2] [13] [14]
      • 10 mg/dose, as required, max. 3x daily. Max: 30 mg/day.
  • Rectal
    • 12 years up to 18 years
      • 30 mg/dose, as required, max. twice daily. Max: 60 mg/day.
Important information DHPC
  • Route of administration not applicable
    • 0 years up to 18 years

      • The paediatric Formulary has reviewed it's dosing recommendations in concordance with the DHPC. The Formulary maintain the dosing recommendations fo domperidone, but only for gastro-esophageal reflux disease and nausea and vomiting which is NOT caused by gastro-enteritis (without cerebral cause). It has been taken into account that metocloprmaide as an alternative for domperidone in nausea and vomiting has a greater risk for extrpyramidal side effects. There is no new evidence on the safety of domperidone in children.

        The Formulary already recommended against use of domperidone for nausea and vomiting in acute gastro-enteritis. (see warnings & precautions section)

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: dose adjustment is not needed.

GFR <10 ml/min/1.73m2: decrease frequency of administration to 1-2 times daily. It might be needed to lower the dose. 

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

(reversible) Extrapyramidal side effects, especially in young children because the blood-brain barrier is not yet fully developed in them. In addition to extrapyramidal disorders, urinary retention and gynaecomastia have also been described. Extended QT interval

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in children

Hypersensitivity, extended QTc interval, hepatic function disorders and gastrointestinal bleeding, mechanical obstruction or gastrointestinal perforation where stimulation of gastrointestinal motility is a risk.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Domperidone has no place in the treatment of acute gastroenteritis. Vomiting disappears soon after rehydration therapy is started. Antiemetics can easily cause central side effects in young children in particular, and severe dystonic reactions have been described in particular when using domperidone for dehydration.
Domperidone only has a place in the treatment of reflux complaints in very occasional cases (source: Dutch Association for Paediatric Medicine (NVK) guideline for Treatment of Reflux symtoms, 2012)

Caution is needed in children aged under one year. The metabolic functions and the blood-brain barrier are not fully developed in premature babies and neonates. The risk of neurological side effects such as sleepiness or extrapyramidal disorders is greater in this group. For that reason, it is recommended that the dosage should be carefully determined and strictly followed in babies, infants, toddlers and young children. In severe renal function disorders, lower the dosing frequency to 1-2x daily.

Domperidone can extend the QTc interval. Caution is therefore needed when there are risk factors for QTc interval extension (hypokalaemia/impaired renal function/diabetes mellitus/other medication that extends QTc or increases the concentrations/high dose/pre-existing extended QT interval or long QT syndrome). If there are risk factors, an ECG check should be done prior to the therapy.

 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Propulsives
A03FA01

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References

  1. Hunsel F van, et al, Risico bij kinderen. Domperidon en extrapiramidale stoornissen, PW, 2007, 39, 33
  2. Johnson&Johnson, SPC Motilium (RVG 07679) 02-05-2019, www.cbg-meb.nl
  3. Rademaker C.M.A., Geneesmiddelen Formularium voor Kinderen WKZ, 2008
  4. Meyboom RH, et al, Acute extrapyramidal movement disorders in young children and adults during administration of domperidone, Ned Tijdschr Geneeskd, 1988, 132, 1981-3
  5. Cresi F, et al, Short-term effect of domperidone on gastroesophageal reflux in newborns assessed by combined intraluminal impedance and pH monitoring, J Perinatol, 2008, 28, 766-70
  6. Dailly E, et al, Population pharmacokinetics of domperidone in preterm neonates, Eur J Clin Pharmacol, 2008, 64, 1197-1200
  7. DeCamp LR, et al, Use of antiemetic agents in acute gastroenteritis: a systematic review and meta-analysis, Arch Pediatr Adolesc Med, 2008, 162, 858-65
  8. Djeddi D, et al, Effect of domperidone on QT interval in neonates, J Pediatr, 2008, 153, 663-6
  9. Günlemez A, et al, Effect of domperidone on the QTc interval in premature infants, J Perinatol, 2010, 30, 50-3
  10. Scott B, Question 2. How effective is domperidone at reducing symptoms of gastro-oesophageal reflux in infants?, Arch Dis Child, 2012, Aug;97(8), 752-5
  11. Tighe MP, et al, Current pharmacological management of gastro-esophageal reflux in children: an evidence-based systematic review, Pediatric Drugs, 2009, 11, 185-202
  12. Vandenplas Y et al, Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint recommendations of the North American Society of Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society of Pediatric Gastroenterology, Hepatology, and Nutri, Pediatr Gastroenterol Nutr, 2009, 49, 498-547
  13. EMA Pharmacovigilance Risk Assessment Committee (PRAC), EMA/129231/2014, www.ema.europa.eu, 7 maart 2014
  14. Nederlandse Vereniging voor Kindergeneeskunde, Richtlijn Palliatieve zorg voor kinderen, 2013, Versie 1.0 Augustus
  15. Leitz G et al, Safety and efficacy of low dose domperidone for treating nausea and vomiting due to acute gastroenteritis in children, J Pediatr Gastroenterol Nutr, 2019, Epub Ahead of Print
  16. Joint Marketing Authorisation Holders, DHPC Domperidon 25-06-2019, www.geneesmiddeleninformatiebank.nl

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Changes

Changes