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.
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
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dexlansoprazole (Dexilant®) | 30 mg, 60 mg delayed- release capsules | erosive esophagitis (EE) |
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gastroesophageal reflux disease (GERD) - nonerosive |
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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 |
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EE |
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GERD - nonerosive |
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lansoprazole (Prevacid®, generics) | 15 mg, 30 mg delayed-release capsules, 15 mg, 30 mg orally disintegrating tablets | EE |
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GERD - nonerosive |
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omeprazole (Prilosec®, generics) | 10 mg, 20 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet | EE |
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GERD - nonerosive |
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omeprazole magnesium (Prilosec®) | 2.5 mg, 10 mg packet with delayed-release granules for suspension | EE |
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GERD - nonerosive |
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pantoprazole (Protonix®, generics) | 20 mg, 40 mg delayed-release tablets; 40 mg delayed-release granules for suspension | EE |
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rabeprazole (Aciphex®, generics) | 20 mg delayed-release tablet; 5 mg, 10 mg delayed-release sprinkle capsule | GERD - nonerosive |
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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
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
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dexlansoprazole (Dexilant®) | 30 mg, 60 mg delayed- release capsules | erosive esophagitis (EE) |
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omeprazole (Prilosec®, generics) | 10 mg, 20 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet | EE |
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omeprazole magnesium (Prilosec®) | 2.5 mg, 10 mg packet with delayed-release granules for suspension | EE |
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Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
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esomeprazole/ naproxen (Vimovo®, generics) | 20 mg immediate-release/375 mg delayed-release, 20 mg immediate-release/500 mg delayed-release tablets | juvenile idiopathic arthritis |
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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.
Treatment Option | Maximum Recommended Dosage |
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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