Omeprazole

Generic name
Omeprazole
Brand name
ATC Code
A02BC01
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Omeprazole

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

From 1 year:
tmax = 1.5-2 hours (sometimes also outliers to 6 hours)
t½ = 0.5-2.5 hours (shorter in young children than in older children)
Cmax and AUC (also after correcting for the dosage) are lower in young children

Neonates of < 10 days:
t½ = 3-10 hours

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Eradication of H. pylori (triple therapy)
  • Oral
    • 1 month up to 18 years
      [20]
      • 1.5 - 2.5 mg/kg/day in 2 doses. Max: 80 mg/day.
      • Duration of treatment:

        14 days

      • Triple therapy: omeprazole combined with:
        - clarithromycin 20-30 mg/kg/day in 2 doses, max 1000 mg/dag OR alternatively metronidazole 20-30 mg/kg/day in 2 doses, max 1000 mg/dag
        - amoxicillin 50 mg/kg/day in 2 doses. In clarithromycin and metronidazole resistency use high dose amoxicillin 80-90 mg/kg/day

        <Insert hyperlinks to drug monographs>
Gastro-oesophageal reflux disease (GERD/GORD), reflux oesophagitis, duodenal or peptic ulcers, bleeding ulcers. Prophylaxis of stress ulcers and/or high intestinal bleeding on admission to IC
  • Oral
    • Term neonate
      [17]
      • 1 mg/kg/day in 1 dose. Max: 3 mg/kg/day.
        • Split over 2 doses if the effect is insufficient
        • If the effect is then still insufficient, increase the does in steps of 0.5 mg/kg/day to a maximum of 3 mg/kg/day.
    • 1 month up to 1 year
      [4] [14] [16] [17]
      • 1 mg/kg/day in 1 dose. Max: 3 mg/kg/day.
        • Split over 2 doses if the effect is insufficient
        • If the effect is then still insufficient, increase the does in steps of 0.5 mg/kg/day to a maximum of 3 mg/kg/day.
    • 1 year up to 18 years
      [4] [14] [16]
      • 1.5 - 3 mg/kg/day in 1 - 2 doses. Max: 80 mg/day.
  • Intravenous
    • Term neonate
      [17]
      • 1 - 2 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.

      • The aim of the therapy is to keep the pH of the stomach above 4 for ≥ 94% of the day. If there is doubt about the effectiveness of the therapy, the pH of the stomach can be determined, taking account of fluctuations.

    • 1 month up to 18 years
      [6] [15] [17]
      • 1 - 2 mg/kg/day in 1 - 2 doses. Max: 40 mg/day.

      • The aim of the therapy is to keep the pH of the stomach above 4 for ≥ 94% of the day. If there is doubt about the effectiveness of the therapy, the pH of the stomach can be determined, taking account of fluctuations.

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.

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

Respiratory side effects and fever (particularly < 2 years). Possibly elevated risk of infections by the oral route, particularly in the high-risk group. The side effects are otherwise the same as in adults.

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

The aim of the therapy is to keep the pH of the stomach above 4 for ≥ 94% of the day. If there is doubt about the effectiveness of the therapy, the pH of the stomach can be determined, taking account of fluctuations.

When omeprazole is used, the stomach contents may turn a purple colour. In the tablets and capsules, the omeprazole is contained in granules that are incorporated into the tablets and capsules.  In the suspension, the omeprazole is in an alkaline liquid. When omeprazole is broken down too early in an acidic environment such as the stomach, the stomach contents may turn purple. This discoloration is not harmful but may indicate reduced activity. 

The Pedippi suspension is thick and this can cause problems in swallowing in young children. Dilute the suspension with a small amount of formula or breastmilk (20-30ml) to prevent choking.

Interactions

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

DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

H2-receptor antagonists
A02BA02
Proton pump inhibitors
A02BC05
A02BC02

References

  1. Andersson T, et al, Pharmacokinetics of orally administered omeprazole in children. International Pediatric Omeprazole Pharmacokinetic Group. , Am J Gastroenterol., 2000, Nov;95(11), 3101-6
  2. Marier JF, et al, Pharmacokinetics of omeprazole in healthy adults and in children with gastroesophageal reflux disease. , Ther Drug Monit., 2004, Feb;26(1), 3-8
  3. Jacqz-Aigrain E, et al, Pharmacokinetics of intravenous omeprazole in children., Eur J Clin Pharmacol, 1994, 47(2), 181-5
  4. Hassall E, et al, Omeprazole for treatment of chronic erosive esophagitis in children: a multicenter study of efficacy, safety, tolerability and dose requirements. International Pediatric Omeprazole Study Group, J Pediatr, 2000, Dec;137(6), 800-7
  5. Boccia G, et al, Maintenance therapy for erosive esophagitis in children after healing by omeprazole: is it advisable?, Am J Gastroenterol, 2007, Jun;102(6), 1291-7
  6. Faure C, et al, Intravenous omeprazole in children: pharmacokinetics and effect on 24-hour intragastric pH, J Pediatr Gastroenterol Nutr, 2001, Aug;33(2), 144-8
  7. Litalien C, et al, Pharmacokinetics of proton pump inhibitors in children, Clin Pharmacokinet, 2005, 44(5), 441-66
  8. Kaufman SS, et al, Omeprozole therapy in pediatric patients after liver and intestinal transplantation., J Pediatr Gastroenterol Nutr, 2002, Feb;34(2), 194-8
  9. Bahremand S, et al, Evaluation of triple and quadruple Helicobacter pylori eradication therapies in Iranian children: a randomized clinical trial. , Eur J Gastroenterol Hepatol., 2006, May;18(5), 511-4
  10. Francavilla R, et al , Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial., Gastroenterology, 2005, Nov;129(5), 1414-9
  11. Gottrand F, et al, Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial., J Pediatr. , 2001, Nov;139(5), 664-8
  12. Behrens R, et al, Dual versus triple therapy of Helicobacter pylori infection: results of a multicentre trial., Arch Dis Child. , 1999, Jul;81(1), 68-70
  13. AstraZeneca BV. , SPC Losec MUPS en Losec Infuus. 21-5-2013, www.CBG-MEB.nl
  14. Bishop J, et al, Omeprazole for gastroesophageal reflux disease in the first 2 years of life: a dose-finding study with dual-channel pH monitoring, J Pediatr Gastroenterol Nutr, 2007, Jul;45(1), 50-5
  15. Solana MJ, et al, 0.5 mg/kg versus 1 mg/kg of intravenous omeprazole for the prophylaxis of gastrointestinal bleeding in critically ill children: a randomized study, J Pediatr, 2013, Apr 162(4), 776-782
  16. Ummarino D, et al, Impact of antisecretory treatment on respiratory symptoms of gastroesophageal reflux disease in children, Dis Esophagus, 2012, Nov-Dec;25(8), 671-7
  17. P.Bestebreurtje, Expertopinie dosering omeprazol < 1 jaar., 04 feb 2014
  18. NVK. , Richtlijn Helicobacter Pylori-infectie bij kinderen van 0-18 jaar., 2012
  19. Lareb Signalering, Omeprazole suspension and regurgitated gastric content discoloured, www.lareb.nl, 01 november 2017
  20. Jones N, et al, Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016), JPGN, 2017, 64, 991–1003
  21. UpToDate, Lexicomp® Drug Interactions: Omeprazole, 04/2018
  22. STADA, SmPC Omeprazol STADA® 10 mg/20 mg/40 mg magensaftresistente Hartkapseln (72556.00.00, 72557.00.00, 72558.00.00), 04/2017
  23. DAZ.online, Individuell für Kinder, Accessed March 19, 2018
  24. Breitkreutz J, Boos J, Paediatric and geriatric drug delivery. Expert opinion on drug delivery, 2007;4(1)
  25. MMI, Gelbe Liste Online, Accessed March 19, 2018
  26. Hexal, SmPC OMEP® HEXAL 20 mg, magensaftresistente Hartkapseln (47677.00.00), 03/2017
  27. STADA, SmPC Omeprazol STADA® 40 mg magensaftresistente Tabletten (50280.00.00), 02/2017
  28. Hexal, SmPC OMEP® 40 mg Pulver zur Herstellung einer Infusionslösung (72931.00.00), 03/2017
  29. STADA, SmPC Omeprazol STADA® 10 mg/ 20 mg/ 40 mg magensaftresistente Hartkapseln (72556.00.00, 72557.00.00, 72558.00.00), 04/2017
  30. Hexal, SmPC OMEP® 10 mg/ 40 mg magensaftresistente Hartkapseln (72641.00.00, 72643.00.00), 03/2017
  31. STADA, SmPC Omeprazol STADA® 20 mg magensaftresistente Tabletten (50201.00.00), 02/2017
  32. Hexal, SmPC OMEP® MUT® 10 mg/ 20 mg/ 40 mg magensaftresistente Tabletten (77273.00.00, 77274.00.00, 77275.00.00), 03/2017
  33. AstraZeneca, SmPC Antra MUPS® 10 mg/20 mg magensaftresistente Tabletten (40292.02.00, 39993.00.00), 01/2017
  34. Bijwerkingencentrum LAREB (Dutch Pharmacovigilance center), Signals 2021: Omeprazole suspension and product physical consistency issues, https://databankws.lareb.nl/Downloads/Signals_2021_omeprazol_suspension_quality-issue.pdf, 2021, Dec, 20

Changes

Therapeutic Drug Monitoring


Overdose