1.2. Pediatrics

Printer-friendly version

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 – Monotherapy^1-8,13
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/day 5 kg to 7.5 kg: 5 mg/day 7.5 kg to 12 kg: 10 mg/day
		EE	1 to 11 years of age: Less than 20 kg: 10 mg/day Greater than or equal to 20 kg: 20 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: Less than or equal to 30 kg: 15 mg/day Greater than 30 kg: 30 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 due to acid-mediated GERD	1 to 16 years of age: 5 kg to less than 10 kg: 5 mg/day 10 kg to less than 20 kg: 10 mg/day Greater than or equal to 20 kg: 20 mg/day
		GERD	1 to 16 years of age: 5 kg to less than 10 kg: 5 mg/day 10 kg to less than 20 kg: 10 mg/day Greater than or equal to 20 kg: 20 mg/day
omeprazole magnesium (Prilosec)	2.5 mg, 10 mg packet with delayed-release granules for suspension	EE due to acid-mediated GERD	1 month to less than 1 year of age: 3 kg to less than 5 kg: 2.5 mg/day 5 kg to less than 10 kg: 5 mg/day Greater than 10 kg: 10 mg/day 1 to 16 years of age: 5 kg to less than 10 kg: 5 mg/day 10 kg to less than 20 kg: 10 mg/day Greater than 20 kg: 20 mg/day
		GERD	1 to 16 years of age: 5 kg to less than 10 kg: 5 mg/day 10 kg to less than 20 kg: 10 mg/day Greater than or equal to 20 kg: 20 mg/day
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	GERD - nonerosive	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 conditions [5]

Table 6. Pediatric Maximum Daily Maintenance Doses for Proton Pump Inhibitors – Monotherapy^1,2,4,5,8
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/day 10 kg to less than 20 kg: 10 mg/day Greater than or equal to 20 kg: 20 mg/day
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/day 10 kg to less than 20 kg: 10 mg/day Greater than of equal to 20 kg: 20 mg/day

Table 7. Pediatric Maximum Daily Maintenance Doses for Proton Pump Inhibitors – Combination Therapy^1,2,11
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 2023 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
clarithromycin sensitive amoxicillin clarithromycin PPI*	15-24 kg: 500 mg three times daily; 25-34 kg: 750 mg three times daily; Greater than or equal to 35 kg: 1 g three times 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
clarithromycin resistant amoxicillin metronidazole PPI*	15-24 kg: 500 mg three times daily; 25-34 kg: 750 mg three times daily; Greater than or equal to 35 kg: 1 g three times daily 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg+ in evening; 35-49 kg: 500 mg twice daily; greater than 50 kg: 750 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
clarithromycin resistant bismuth subsalicylate 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 three times daily; 25-34 kg: 750 mg three times daily; greater than or equal to 35 kg: 1 g three times daily 15-24 kg: 250 mg twice daily; 25-34 kg: 500 mg in morning, 250 mg+ in evening; 35–49 kg: 500 mg twice daily; greater than or equal to 50 kg: 750 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

Legend:

* PPI dosing is based on esomeprazole. Esomeprazole is preferred in the guideline since it is less susceptible to degradation by rapid metabolizers with relevant cytochrome polymorphisms
+ if oral metronidazole suspension used, dose may be divided equally every 12 hours
# if patient is resistant or allergic to amoxicillin and is > 8 years old, may substitute amoxicillin with a tetracycline antibiotic