2. Duration of Therapy

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PPI acute treatment durations for both adult and pediatric patients based on FDA-approved indications are summarized in Tables 9-11.

Table 9. PPI Acute Duration of Therapy for Adult Patients – Monotherapy^1-9
Drug Name	Treatment Indication	Maximum Therapy Duration
dexlansoprazole (Dexilant®)	erosive esophagitis (EE)	8 weeks
	gastroesophageal reflux disease (GERD) - nonerosive	4 weeks
esomeprazole magnesium (Nexium®, generics)	EE	8 weeks^
	GERD	4 weeks+
	heartburn	14 days*
esomeprazole strontium	EE	8 weeks^
	GERD	4 weeks+
lansoprazole (Prevacid®, generics)	duodenal ulcer	4 weeks
	EE	8 weeks#
	gastric ulcer	8 weeks
	GERD	8 weeks
	heartburn	14 days*
	NSAID-associated gastric ulcer	without prior gastric ulcer: 8 weeks with prior gastric ulcer: 12 weeks
omeprazole (Prilosec®, generics)	duodenal ulcer	4 weeks+
	EE	8 weeks#
	gastric ulcer	8 weeks
	GERD	4 weeks
	heartburn	14 days*
omeprazole magnesium (Prilosec®)	duodenal ulcer	4 weeks+
	EE	8 weeks#
	gastric ulcer	8 weeks
	GERD	4 weeks
pantoprazole (Protonix®, generics)	EE	8 weeks#
rabeprazole (Aciphex®, generics)	duodenal ulcer	4 weeks+
	EE	8 weeks#
	GERD	4 weeks+

Legend:

^ may consider an additional 4- to 8-week treatment course in patients who do not heal with initial treatment
+ may consider an additional 4-week treatment course in patients who do not heal with initial treatment
# may consider an additional 8-week treatment course in patients with incomplete healing or EE recurrence after initial treatment
* PPI treatment duration should not exceed 14 days during a 4-month period, unless alternate instructions are provided by a physician

Table 10. PPI Acute Duration of Therapy for Adult Patients – Combination Therapy^1,2,10
Drug Name	Treatment Indication	Maximum Therapy Duration
omeprazole/sodium bicarbonate (Zegerid®, generics)	duodenal ulcer	4 weeks+
	EE	8 weeks#
	gastric ulcer	8 weeks
	GERD	4 weeks

Legend:

+ may consider an additional 4-week treatment course in patients who do not heal with initial treatment
# may consider an additional 8-week treatment course in patients with incomplete healing or EE recurrence after initial treatment

Table 11. PPI Acute Duration of Therapy for Pediatric Patients – Monotherapy^1-8,13
Drug Name	Treatment Indication	Maximum Therapy Duration
dexlansoprazole (Dexilant®)	erosive esophagitis (EE)	12 to 17 years of age: 8 weeks
esomeprazole magnesium (Nexium®, generics)	EE due to only acid-mediated GERD	1 to 11 months of age: 6 weeks
	EE	1 to 11 years of age: 8 weeks 12 to 17 years of age: 8 weeks
	symptomatic GERD - nonerosive	1 to 11 years of age: 8 weeks 12 to 17 years of age: 4 weeks
lansoprazole (Prevacid®, generics)	EE	1 to 11 years of age: 12 weeks 12 to 17 years of age: 8 weeks
	GERD	1 to 11 years of age: 12 weeks 12 to 17 years of age: 8 weeks
omeprazole (Prilosec®, generics)	EE	1 to 16 years of age: 12 weeks∞
omeprazole magnesium (Prilosec®)	EE	1 month to less than 1 year of age: 6 weeks 1 to 16 years of age: 12 weeks^
	GERD	1 to 16 years of age: 4 weeks
pantoprazole (Protonix®, generics)	EE	Greater than or equal to 5 years of age: 8 weeks
rabeprazole (Aciphex®, generics)	GERD	1 to 11 years of age: 12 weeks 12 to 17 years of age: 8 weeks

Legend:

^ may consider an additional 4- to 8-week treatment course in patients who do not heal with initial treatment
∞ may consider additional 4- to 8-week treatment course with EE or GERD recurrence

In the acute setting in both adult and pediatric patients older than 11 months of age, 8 weeks of PPI therapy will treat EE and will heal most non-H. pylori duodenal and gastric ulcers. The prescribing health care provider may continue acute dosage regimens for longer than 8 weeks in patients with hypersecretory disease states, esophagitis, or GERD, as well as those patients with risk factors for gastric ulcer treatment failure such as smoking. PPI acute dosage regimens may also exceed 8 weeks in patients with risk factors for delayed duodenal ulcer healing such as daily ethanol use, large ulcers, signs of upper GI bleeding, and/or a previous history of duodenal ulcer. Patients with refractory ulcers, defined as ulcers that do not respond to up to 12 weeks of anti-ulcer therapy, may also require extended PPI therapy. Treatment regimens at acute dosage levels lasting longer than four months (16 weeks) in patients with a diagnosis of acute duodenal or gastric ulcer will be reviewed.

Clinical trials support dexlansoprazole efficacy for maintenance of healed EE and heartburn relief for up to six months in adults and up to 16 weeks in pediatric patients 12 to 17 years of age.

Esomeprazole, when prescribed for risk reduction of NSAID-associated gastric ulcer, may be administered for up to six months, as controlled studies for this indication do not extend beyond this time. Treatment regimens for NSAID-associated gastric ulcers extending beyond designated treatment times for esomeprazole and lansoprazole will be reviewed.

Unless otherwise specified, maintenance therapy, at the recommended daily maintenance dose (Tables 2 and 4), may be continued indefinitely based on patient need. Omeprazole treatment for EE and GERD in pediatric patients may continue indefinitely.

PPI treatment duration in adults for H. pylori eradication is summarized in Table 12. PPI therapy is prescribed for a maximum of 14 days in most patients, as treatment durations exceeding 14 days do not significantly increase eradication rates. In treatment failures, retreatment with an alternate antibiotic regimen has been beneficial. In these circumstances, patients may receive PPI therapy for a maximum of 28 days.

Table 12. Proton Pump Inhibitor Recommended Therapy Duration in Adults for H. pylori Eradication^3-6,9
Drug Name	Recommended Therapy Duration
esomeprazole	with triple therapy: 10 days
lansoprazole	with dual therapy: 14 days with triple therapy: 10-14 days
lansoprazole	with dual therapy: 14 days with triple therapy: 10-14 days
omeprazole	with ulcer present at treatment initiation: dual or triple therapy: 28 days without ulcer present at treatment initiation: dual therapy: 14 days triple therapy: 10 days
rabeprazole	with triple therapy: 7 days

Pediatric treatment regimens for H. pylori eradication reported in guidelines and clinical trials should be administered for 10 to 14 days. Pediatric sequential therapy for H. pylori eradication is comprised of a PPI plus amoxicillin administered for 5 days, followed by a PPI plus metronidazole plus clarithromycin given for 5 days.