Auro-Pantoprazole

Gastroesophageal Reflux Disease (GERD)

For the treatment of erosive GERD or upper GI malignancy; OR

For the treatment of non-erosive GERD after failure of H2-receptor antagonist therapy.

Patients with GERD should be reassessed within 6 months after initial treatment with a PPI.  The reassessment could include confirmation of need for PPI with endoscopy, a trial of PPI withdrawal, or step-down therapy to H2-receptor antagonist therapy.

Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.

H. pylori-positive Peptic Ulcers

For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, urea breath test or endoscopy, for a course of up to 14 days in combination with antimicrobial therapy. Retreatment of H. pylori-positive peptic ulcers must be documented by persistent H. pylori infection on urea breath test or endoscopy.

Maximum duration: 14 days (for retreatment, a four-week period must elapse since the end of the previous treatment).

Confirmed Peptic Ulcers or NSAID-induced Ulcer Prophylaxis:

For the treatment of confirmed peptic ulcers and NSAID-induced ulcers; OR

For the prophylaxis of NSAID-induced ulcers for patients at increased risk of GI bleeding.

Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.

Other Gastrointestinal Disorders:

For the treatment of gastroduodenal Crohn's disease, short-gut syndrome, scleroderma, or pancreatitis.

Note: There is a lack of published evidence to support double-dose PPI therapy in these settings.

Severe Conditions:

For the treatment of severe esophagitis, Zollinger-Ellison syndrome, esophageal stricture, persistent symptoms of GERD or persistent erosive esophagitis, or upon hospital discharge following a gastrointestinal bleed.

For patients receiving double-dose therapy, the need to continue treatment at higher doses should be reassessed after eight weeks. For re-treatment at higher doses, a four-week period should have elapsed from the end of the previous treatment. Reassessment could include a procedural assessment of the condition or step-down therapy to lower-dose proton pump inhibitor (PPI) therapy.