Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+ ,K+ )-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+,K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested.

PROTONIX® Delayed-Release Tablets and PROTONIX® For Delayed-Release Oral Suspension are indicated for: Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD) PROTONIX® is indicated for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. See package insert for complete information.

Treatment of Erosive Esophagitis: The recommended adult oral dose is 40 mg given once daily for up to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. See package insert for complete information.

Worldwide, more than 11,100 patients have been treated with pantoprazole in clinical trials involving various dosages and duration of treatment. In general, pantoprazole has been well tolerated in both short-term and long-term trials. The adverse reaction profile for PROTONIX® (pantoprazole sodium) For Delayed-Release Oral Suspension is similar to the established safety profile of PROTONIX® (pantoprazole sodium) Delayed-Release Tablets. In two U.S. controlled clinical trials involving PROTONIX 10-, 20-, or 40-mg doses for up to 8 weeks, there were no dose-related effects on the incidence of adverse events. The following adverse events considered by investigators to be possibly, probably, or definitely related to drug occurred in 1% or more in the individual studies of GERD patients on therapy with PROTONIX.

PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation.

Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric malignancy. Owing to the chronic nature of erosive esophagitis, there may be a potential for prolonged administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and caused rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown. See package insert for complete information.