Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+ /K+ -ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.

NEXIUM is a proton pump inhibitor indicated for the following: • Treatment of gastroesophageal reflux disease (GERD). • Risk reduction of NSAID-associated gastric ulcer. • H. pylori eradication to reduce the risk of duodenal ulcer recurrence. • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

See package insert for complete information.

Most common adverse reactions: • Adults (≥ 18 years) (incidence > 1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth • Pediatric (1 to 17 years) (incidence > 2%) are headache, diarrhea, abdominal pain, nausea, and somnolence • Pediatric (1 month to less than 1 year) (incidence 1%) are abdominal pain, regurgitation, tachypnea, and increased ALT

Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred)

• Symptomatic response does not preclude the presence of gastric malignancy. • Atrophic gastritis has been noted with long-term omeprazole therapy. • Acute interstitial nephritis has been observed in patients taking PPIs. • Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. • PPI therapy may be associated with increased risk of Clostridiu difficile associated diarrhea. • Avoid concomitant use of NEXIUM with clopidogrel. • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. See package insert for complete information.