Maximum daily adult doses for PPIs when prescribed as acute and maintenance therapy, as well as components of combination treatments, are summarized in Tables 1-4. Dosages exceeding these recommended values will be reviewed.

Table 1. Adult Maximum Daily Acute Doses for Proton Pump Inhibitors – Monotherapy^1-9

Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
dexlansoprazole (Dexilant)	30 mg, 60 mg delayed- release capsules	erosive esophagitis (EE)	60 mg/day
		gastroesophageal reflux disease (GERD) - nonerosive	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	40 mg/day
		GERD - nonerosive	20 mg/day
		Helicobacter pylori eradication	40 mg/day*
		heartburn	20 mg/day
		hypersecretory conditions	240 mg/day in divided doses
lansoprazole (Prevacid®, generics)	15 mg, 30 mg delayed-release capsules, 15 mg, 30 mg orally disintegrating tablets	duodenal ulcer	15 mg/day
		EE	30 mg/day
		gastric ulcer	30 mg/day
		GERD - nonerosive	15 mg/day
		H. pylori eradication	90 mg/day (in divided doses)*
		heartburn	15 mg/day
		hypersecretory conditions	180 mg/day in divided doses
		NSAID-associated gastric ulcer	30 mg/day
omeprazole (Prilosec®, generics)	10 mg, 20 mg, 20.6 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet	duodenal ulcer	20 mg/day
		EE	20 mg/day
		gastric ulcer	40 mg/day
		GERD - nonerosive	20 mg/day
		heartburn	20 mg/day
		H. pylori eradication	triple therapy: 40 mg/day in divided doses* dual therapy: 40 mg/day*
		hypersecretory conditions	360 mg/day in divided doses
omeprazole magnesium (Prilosec®)	2.5 mg, 10 mg packet with delayed-release granules for suspension, 20.6 mg delayed-release capsule	duodenal ulcer	20 mg/day
		EE	20 mg/day
		gastric ulcer	40 mg/day
		GERD - nonerosive	20 mg/day
		H. pylori eradication	triple therapy: 40 mg/day in divided doses* dual therapy: 40 mg/day*
		hypersecretory conditions	360 mg/day in divided doses
pantoprazole (Protonix®, generics)	20 mg, 40 mg delayed-release tablets; 40 mg delayed-release granules for suspension	EE	40 mg/day
		hypersecretory conditions	240 mg/day in divided doses
rabeprazole (Aciphex®, generics)	20 mg delayed-release tablet; 5 mg, 10 mg delayed-release sprinkle capsule	duodenal ulcer	20 mg/day
		EE	20 mg/day
		GERD - nonerosive	20 mg/day
		H. pylori eradication	40 mg/day in divided doses*
		hypersecretory conditions	120 mg/day in divided doses

Legend:

• *Per ACG Guidelines, PPI dosing may be doubled depending on the regimen used for H. Pylori eradication¹²

Table 2. Adult Maximum Daily Acute Doses for Proton Pump Inhibitors – Combination Therapy^1,2,10

Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
omeprazole/ sodium bicarbonate (Zegerid®, generics)	20 mg/1100 mg, 40 mg/1100 mg capsules; 20 mg/1680 mg, 40 mg/1680 mg packets for suspension	duodenal ulcer	20 mg/day (as mg of omeprazole)
		EE	20 mg/day (as mg of omeprazole)
		gastric ulcer	40 mg/day (as mg of omeprazole)
		GERD - nonerosive	20 mg/day (as mg of omeprazole)
		heartburn	20 mg/day (as mg of omeprazole)
		upper GI bleed risk reduction in critically ill (suspension only)	Day 1: 80 mg (in divided doses); Days 2-14: 40 mg/day (as mg of omeprazole)

Table 3. Adult Maximum Daily Maintenance Dose for Proton Pump Inhibitors – Monotherapy^1-9

Drug Name	Dosage Form/Strength	Treatment Indication	Maximum Recommended Dosage
dexlansoprazole (Dexilant)	30 mg, 60 mg delayed- release capsules	erosive esophagitis (EE)	30 mg/day
		heartburn	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	20 mg/day
		hypersecretory conditions	240 mg/day in divided doses
		risk reduction of NSAID-associated gastric ulcer	40 mg/day
lansoprazole (Prevacid®, generics)	15 mg, 30 mg delayed-release capsules, 15 mg, 30 mg orally disintegrating tablets	duodenal ulcer	15 mg/day
		EE	15 mg/day
		hypersecretory conditions	180 mg/day in divided doses
		hypersecretory conditions	180 mg/day in divided doses
		risk reduction of NSAID-associated gastric ulcer	15 mg/day
omeprazole (Prilosec®, generics)	10 mg, 20 mg, 40 mg delayed-release capsule; 20 mg delayed-release orally disintegrating tablet	EE	20 mg/day
		hypersecretory conditions	360 mg/day in divided doses
omeprazole magnesium (Prilosec®)	2.5 mg, 10 mg packet with delayed-release granules for suspension	EE	20 mg/day
		hypersecretory conditions	360 mg/day in divided doses
pantoprazole (Protonix®, generics)	20 mg, 40 mg delayed-release tablets; 40 mg delayed-release granules for suspension	EE	40 mg/day
		hypersecretory conditions	240 mg/day in divided doses
rabeprazole (Aciphex®, generics)	20 mg delayed-release tablet; 5 mg, 10 mg delayed-release sprinkle capsule	EE	20 mg/day
		hypersecretory conditions	120 mg/day in divided doses

Caption^XXX

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	prevention of NSAID-associated gastric ulcer in patients with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis	40 mg/1000 mg/day in divided doses
omeprazole/ sodium bicarbonate (Zegerid®, generics)	20 mg/1100 mg, 40 mg/1100 mg capsules; 20 mg/1680 mg, 40 mg/1680 mg packets for suspension	EE	20 mg/day (as mg of omeprazole)

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 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 – 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 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 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 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

Dosage adjustments are not necessary when PPIs are prescribed as monotherapy to patients with renal impairment. Omeprazole/sodium bicarbonate therapy also does not require dosage adjustments in renally impaired patients. However, the esomeprazole/naproxen combination is not recommended for use in patients with a creatinine clearance below 30 ml/min due to the potential for naproxen/naproxen metabolite accumulation and increased risk for adverse events.