Esomeprazole

Esomeprazole Gastro-resistant tablets are indicated in adults for:

Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis. - Long-term management of patients with healed esophagitis to prevent relapse. - Symptomatic treatment of gastroesophageal reflux disease (GERD). In combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and - Healing of Helicobacter pylori associated duodenal ulcer.

- Prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers. Patients requiring continued NSAID therapy - Healing of gastric ulcers associated with NSAID therapy. - Prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk.

V. induced prevention of rebleeding of peptic ulcers Treatment of Zollinger Ellison Syndrome Esomeprazole gastro-resistant tablets are indicated in adolescents from the age of 12 years for: Gastroesophageal Reflux Disease (GERD) - Treatment of erosive reflux esophagitis.

e. heartburn and regurgitation)  healing of NSAID*-associated gastric ulcers  reduction of risk of NSAID-associated gastric ulcers  treatment of pathological hypersecretory conditions, including Zollinger -Ellison syndrome  Helicobacter pylori (H.

pylori) eradication NEXIUM, in combination with clarithromycin and amoxicillin, is indicated for the treatment of patients with duodenal ulcer disease associated with Helicobacter pylori infection to eradicate the H. pylori and heal ulcers.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. *Note: Superiority of NEXIUM over ranitidine 150 mg BID with the use of non -selective NSAIDs was demonstrated. Superiority was not established with the use of COX-2 selective NSAIDs alone due to the small number of patients analyzed in this subgroup (see Table 16).

1 Pediatrics Pediatrics (1-17 years of age) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of NEXIUM in pediatric patients has been established. Therefore, Health Canada has authorized the following indication for pediatric use.

1 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI).

Esomeprazole magnesium delayed-release capsules are indicated for the:

Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. 1 ) Maintenance of healing of EE in adults. 2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.

3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. 4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.

5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. 1 Healing of Erosive Esophagitis (EE) Adults Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults.

g. heartburn and acid regurgitation) in adults.