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

Interactions
PK
Renal impairment
References

Esomeprazole

Generic name
Esomeprazole
Brand name
ATC Code
A02BC05

Pharmacokinetics in children

The kinetics of esomeprazole in children > 5 years are the same as those in adults. In younger children, the kinetics seem to be dose-dependent and age-dependent. Metabolization per kg bodyweight is faster in children aged 1-5 years

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

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Available formulations

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Dosages

Gastro-oesophageal reflux disease
  • Oral
    • 1 month up to 12 years and 5 up to 10 kg
      [1] [7]
      • 5 mg/day in 1 dose

      • NOTE: Fixed dosage instead of mg/kg dosage!

    • 1 month up to 12 years and ≥ 10 kg
      [1] [7]
      • 10 mg/day in 1 dose
      • Duration of treatment:

        Up to 8 weeks

      • Gastro-resistant granules

    • 12 years up to 18 years
      [1]
      • 20 mg/day in 1 dose
      • Duration of treatment:

        For a maximum of 4 weeks; in recurrent complaints, the maintenance dose is 20 mg once a day.

  • Intravenous
    • Term neonate
      [3]
      • 0.5 mg/kg/day in 1 dose
      • Directions for administration:

        Infuse over 10-30 min, inject over at least 3 minutes

    • 1 month up to 1 year
      [2] [3]
      • 0.5 - 1 mg/kg/day in 1 dose. Max: 10 mg/day.
      • Directions for administration:

        Infuse over 10-30 min, inject over at least 3 minutes

    • 1 year up to 12 years
      [2]
      • 10 mg/day in 1 dose

      • Infuse over 10-30 min, inject over at least 3 minutes

    • 12 years up to 18 years
      [2]
      • 20 mg/day in 1 dose

      • Infuse over 10-30 min, inject over at least 3 minutes
Eradication of H. pylori (triple therapy)
  • Oral
    • 1 month up to 18 years
      [9]
      • 1.5 - 2.5 mg/kg/day in 2 doses. Max: 80 mg/day.
      • Duration of treatment:

        14 days

      • Triple therapy: esomeprazole combined with:
        - clarithromycin 20-30 mg/kg/day in 2 doses, max. 1000 mg/day Or Alternatively metronidazol 20-30 mg/kg/day in 2 doses, max 1000 mg/day
        - amoxicillin 50 mg/kg/day in 2 doses, max 2000 mg/day, In clarithromycin or metronidazol resistency use high dose 80-90 mg/kg/day, max 6000 mg/day

    • 4 years up to 18 years and ≥ 30 kg
      • 40 mg/day in 2 doses.
      • Duration of treatment:

        1 week

      • Triple therapy: esomeprazole combined with:
        - clarithromycin 15 mg/kg/day in 2 doses, max. 1000 mg/day
        - amoxicillin 50 mg/kg/day in 2 doses, bodyweight 30-40 kg max. 1500 mg/day, > 40 kg max. 2000 mg/day
Reflux oesophagitis
  • Oral
    • 1 month up to 12 years and 5 up to 10 kg
      [1] [7]
      • 5 mg/day in 1 dose
    • 1 month up to 12 years and 10 up to 20 kg
      [1] [7]
      • 10 mg/day in 1 dose
    • 1 month up to 12 years and ≥ 20 kg
      [1] [7]
      • 10 - 20 mg/day in 1 dose
      • Duration of treatment:

        8 weeks

      • Gastro-resistant granules

    • 12 years up to 18 years
      [1]
      • 40 mg/day in 1 dose
      • Duration of treatment:

        Duration of treatment is 4-8 weeks. To prevent recurrences, a maintenance treatment of 20 mg/day in a single dose can be followed.

  • Intravenous
    • 1 month up to 12 years and 10 up to 20 kg
      [2]
      • 10 mg/day in 1 dose
    • 1 month up to 12 years and ≥ 20 kg
      [2]
      • 10 - 20 mg/day in 1 dose

      • Infuse over 10-30 min, inject over at least 3 minutes.

    • 12 years up to 18 years
      [2]
      • 40 mg/day in 1 dose

      • Infuse over 10-30 min, inject over at least 3 minutes.

    • 1 month up to 12 years and 5 up to 10 kg
      [5]
      • 5 mg/day in 1 dose

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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

No information is present at this moment.

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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

No information available on specific contra indications in children.

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

Dose adjustment is needed in children with severe hepatic impairment: 1-11 years: max 10 mg/day; 12-18 years: max 20 mg/d

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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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H2-receptor antagonists
A02BA02
Proton pump inhibitors
A02BC01
A02BC02

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References

  1. AstraZeneca BV, SmPC Nexium sachet (RVG 101600) 17-12-2021, www.geneesmiddelinformatiebank.nl
  2. AstraZeneca BV, SmPC Nexium IV (RVG 30091) 17-12-2021, www.geneesmiddelinformatiebank.nl
  3. Sandström M et al, Phase I, multicenter, randomized, open-label study evaluating the pharmacokinetics and safety profile of repeated once-daily doses of intravenous esomeprazole in children 0 to 17 years of age, Clin Ther., 2012 , Aug;34(8), 1828-38
  4. Zhao J et al, Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastroesophageal reflux disease: a randomized, open-label study, Clin Ther, 2006, Nov;28(11), 1868-76
  5. Omari T. et al, Pharmacokinetics and acid-suppressive effects of esomeprazole in infants 1-24 months old with symptoms of gastroesophageal reflux disease, J Pediatr Gastroenterol Nutr. , 2007, Nov;45(5):, 530-7
  6. Omari T. et al, Pharmacodynamics and systemic exposure of esomeprazole in preterm infants and term neonates with gastroesophageal reflux disease, J Pediatr., 2009, 155(2), 222-8
  7. Winter H et al., Esomeprazole for the treatment of GERD in infants ages 1-11 months, J Pediatr Gastroenterol Nutr. , 2012, Jul;55(1):, 14-20
  8. AVOXA, ABDA-Datenbank Wirkstoffdossier Esomeprazol, Letzte Bearbeitung 04/2019, aufgerufen am 08.04.2019
  9. Jones N, et al, Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016), jp, 2017, 64, 991–1003

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Changes

Changes