1.2. Pediatrics

The safety and efficacy of dexlansoprazole and esomeprazole/naproxen in patients less than 12 years of age as well as omeprazole/sodium bicarbonate in patients less than 18 years of age have not been established.

Esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole are FDA-approved for acute use in pediatric patients; doses are age-dependent. Omeprazole is the only PPI approved for erosive esophagitis maintenance therapy in pediatric patients. The maximum recommended daily pediatric doses for these PPIs are summarized in Tables 5-7. Dosages exceeding these recommendations will be reviewed.

Table 5. Pediatric Maximum Daily Acute Doses for Proton Pump Inhibitors – Monotherapy1-8,13
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
dexlansoprazole (Dexilant®) 30 mg, 60 mg delayed- release capsules erosive esophagitis (EE)
  • 12 to 17 years of age:
    • 60 mg/day
    gastroesophageal reflux disease (GERD) - nonerosive
  • 12 to 17 years of age:
    • 30 mg/day
esomeprazole magnesium (Nexium®, generics) 20 mg, 40 mg delayed-release capsules; 2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg delayed-release powder for suspension EE due to only acid-mediated GERD
  • 1 to 11 months of age:
    • 3 kg to 5 kg:
      • 2.5 mg once daily
    • 5 kg to 7.5 kg:
      • 5 mg once daily
    • 7.5 kg to 12 kg:
      • 10 mg once daily
    EE
  • 1 to 11 years of age:
    • Greater than or equal to 20 kg:
      • 20 mg/day 
    • Less than 20 kg:
      • 10 mg/day
  • 12 to 17 years of age: 40 mg/day
    GERD - nonerosive
  • 1 to 11 years of age:
    • 10 mg/day
  • 12 to 17 years of age:
    • 20 mg/day
lansoprazole (Prevacid®, generics) 15 mg, 30 mg delayed-release capsules, 15 mg, 30 mg orally disintegrating tablets EE
  • 1 to 11 years of age:
    • Greater than or equal to 30 kg:
      • 30 mg/day* 
  • Less than 30 kg: 15 mg/day
    • 12 to 17 years of age:
      • 30 mg/day*
    GERD - nonerosive
  • 1 to 11 years of age:
    • Less than or equal to 30 kg:
      • 15 mg/day
    • Greater than 30 kg:
      • 30 mg/day 
  • 12 to 17 years of age:
    • 15 mg/day
omeprazole (Prilosec®, generics) 10 mg, 20 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet EE
  • 1 to 16 years of age:
    • 5 kg to less than 10 kg:
      • 5 mg once daily
    • 10 kg to less than 20 kg:
      • 10 mg once daily
  • Greater than or equal to 20 kg:
    • 20 mg once daily
    GERD - nonerosive
  • 1 to 16 years of age:
    • 5 kg to less than 10 kg:
      • 5 mg once daily
    • 10 kg to less than 20 kg:
    • 10 mg once daily
  • Greater than or equal to 20 kg:
    • 20 mg once daily
omeprazole magnesium (Prilosec®) 2.5 mg, 10 mg packet with delayed-release granules for suspension EE
  • 1 month to less than 1 year of age:
    • 3 kg to less than 5 kg:
      • 2.5 mg once daily
  • 5 kg to less than 10 kg: 5 mg once daily
  • Greater than or equal to 10 kg: 10 mg once daily
  • 1 to 16 years of age:
  • 5 kg to less than 10 kg: 5 mg once daily
  • 10 kg to less than 20 kg:  10 mg once daily
  • Greater than equal to 20 kg: 20 mg once daily
    GERD - nonerosive
  • 1 to 16 years of age:
    • 5 kg to less than 10 kg:
      • 5 mg once daily
    • 10 kg to less than 20 kg:
      • 10 mg once daily
  • Greater than or equal to 20 kg:
    • 20 mg once daily
pantoprazole (Protonix®, generics) 20 mg, 40 mg delayed-release tablets; 40 mg delayed-release granules for suspension EE
  • Greater than or equal to 5 years of age:
    • 15 kg to less than 40 kg:
      • 20 mg/day
  • Greater than or equal to 40 kg:
    • 40 mg/day 
rabeprazole (Aciphex®, generics) 20 mg delayed-release tablet; 5 mg, 10 mg delayed-release sprinkle capsule GERD - nonerosive
  • 1 to 11 years of age: 
    • Less than 15 kg:
      • 5 mg/day+
    • Greater than or equal to 15 kg:
      • 10 mg/day 
  • Greater than or equal to 12 years of age:
    • 20 mg/day

Legend:

  • * dose increased to 30 mg twice daily in some children who remained symptomatic after 2 weeks of therapy at lower doses conditions5
  • + may increase to 10 mg daily in those with inadequate response to 5 mg dose using the delayed-release sprinkle capsule13
Table 6. Pediatric Maximum Daily Maintenance Doses for Proton Pump Inhibitors – Monotherapy1,2,4,5,8
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
dexlansoprazole (Dexilant®) 30 mg, 60 mg delayed- release capsules erosive esophagitis (EE)
  • 12 to 17 years of age:
    • 30 mg/day
omeprazole (Prilosec®, generics) 10 mg, 20 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet     EE
  • 1 to 16 years of age:
    • 5 kg to less than 10 kg:
      • 5 mg once daily
    • 10 kg to less than 20 kg:
      • 10 mg once daily
  • Greater than or equal to 20 kg:
    • 20 mg once daily
omeprazole magnesium (Prilosec®) 2.5 mg, 10 mg packet with delayed-release granules for suspension EE
  • 1 to 16 years of age:
    • 5 kg to less than 10 kg:
      • 5 mg once daily
    • 10 kg to less than 20 kg:
      • 10 mg once daily
  • Greater than or equal to 20 kg:
    • 20 mg once daily
Table 7. Pediatric Maximum Daily Maintenance Doses for Proton Pump Inhibitors – Combination Therapy1,2,11
Drug Name Dosage Form/Strength Treatment Indication Maximum Recommended Dosage
esomeprazole/ naproxen (Vimovo®, generics) 20 mg immediate-release/375 mg delayed-release, 20 mg immediate-release/500 mg delayed-release tablets juvenile idiopathic arthritis
  • Greater than or equal to 12 years: 
    • 38 kg to less than 50 kg:
      • 40 mg/750 mg/day in two divided doses
    • Greater than or equal to 50 kg:
      • 40 mg/1000 mg/day in two divided doses

Although not FDA-approved due to limited availability of guidelines and well-designed clinical trials, select proton pump inhibitors have been utilized in combination with antibiotic therapy to manage H. pylori in pediatric patients. The 2016 European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines for H. pylori management in pediatric patients recommend PPI doses of 1-2 mg/kg/day for 10 to 14 days as combination therapy or sequential therapy. Pediatric dosage recommendations for H. pylori management are summarized in Table 8.

Table 8. ESPGHAN/NASPGHAN Pediatric H. pylori Treatment Recommendations14
Treatment Option Maximum Recommended Dosage
  • Option 1:  
    • amoxicillin 
    • clarithromycin
    • PPI
  • 15-24 kg: 500 mg twice daily; 25-34 kg: 750 mg twice daily; Greater than or equal to 35 kg: 1 g twice daily
  • 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg in evening; Greater than or equal to 35 kg: 500 mg twice daily
  • 15-24 kg: 20 mg twice daily; 25-34 kg: 30 mg twice daily; Greater than or equal to 35 kg: 40 mg twice daily
  • Option 2:  
    • amoxicillin
    • metronidazole 
    • PPI
  • 15-24 kg: 500 mg twice daily; 25-34 kg: 750 mg twice daily; Greater than or equal to 35 kg: 1 g twice daily
  • 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg+ in evening; Greater than or equal to 35 kg: 500 mg twice daily
  • 15-24 kg: 20 mg twice daily; 25-34 kg: 30 mg twice daily; Greater than or equal to 35 kg: 40 mg twice daily 
  • Option 3:
    • bismuth salts
    • amoxicillin#
    • metronidazole
    • PPI
  • less than 10 years:  262 mg four times daily; greater than or equal to 10 years: 524 mg four times daily
  • 15-24 kg: 500 mg twice daily; 25-34 kg: 750 mg twice daily: greater than or equal to 35 kg: 1 g twice daily
  • 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg+ in evening; Greater than or equal to 35 kg: 500 mg twice daily
  • 15-24 kg: 20 mg twice daily; 25-34 kg: 30 mg twice daily; Greater than or equal to 35 kg: 40 mg twice daily
  • Sequential therapy*:
    • PPI + amoxicillin
    • followed by
    • PPI + metronidazole + clarithromycin
  • 15-24 kg: 20 mg twice daily; 25-34 kg: 30 mg twice daily; Greater than or equal to 35 kg: 40 mg twice daily
  • 15-24 kg: 500 mg twice daily; 25-34 kg: 750 mg twice daily; Greater than or equal to 35 kg: 1 g twice daily
  • 15-24 kg: 20 mg twice daily; 25-34 kg: 30 mg twice daily; Greater than or equal to 35 kg: 40 mg twice daily
  • 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg+ in evening; Greater than or equal to 35 kg: 500 mg twice daily
  • 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg in evening; Greater than or equal to 35 kg: 500 mg twice daily

Legend:

  • * sequential therapy = PPI + amoxicillin x 5 days followed by PPI + metronidazole + clarithromycin x 5 days
  • + if oral metronidazole suspension used, dose may be divided equally every 12 hours
  • # if patient is resistant or allergic to amoxicillin and is greater than  8 years old, may substitute amoxicillin with a tetracycline antibiotic