NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION

_____________________________________________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEXIUM safely and effectively. See full prescribing information for NEXIUM. NEXIUM (esomeprazole magnesium) DELAYED-RELEASE CAPSULES NEXIUM (esomeprazole magnesium) FOR DELAYED-RELEASE ORAL SUSPENSION INITIAL US APPROVAL: 1989 (omeprazole) -----------------------RECENT MAJOR CHANGES---------------------Dosage and Administration, Pediatric (2) February, 2008 -----------------------INDICATIONS AND USAGE-----------------------NEXIUM is a proton pump inhibitor indicated for the following: • • • • • Treatment of Gastroesophageal Reflux Disease (GERD) (1.1) Risk Reduction of NSAID-Associated Gastric Ulcer (1.2) H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.3) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.4) The safety and effectiveness of NEXIUM in pediatric patients < 1 year of age have not been established. (8.4) --------------------DOSAGE AND ADMINISTRATION-------------------Indication Dose Frequency Treatment of Gastroesophageal Reflux Disease (GERD) (1.1) Adult Dosing 20 mg or 40 mg Once Daily for 4 to 8 Weeks Pediatric Dosing (8.4) 1-11 years 10 mg or 20 mg Once Daily, up to 8 Weeks 12-17 years 20 mg or 40 mg Risk Reduction of NSAID-Associated Gastric Ulcer (1.2) 20 mg or 40 mg Once Daily for up to 6 months H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.3) Triple Therapy: NEXIUM 40 mg Once Daily for 10 Days Amoxicillin 1000 mg Twice Daily for 10 Days Clarithromycin 500 mg Twice Daily for 10 Days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.4) NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. (4) Hypersensitivity reactions e.g., angioedema and anaphylactic reaction/shock have been reported with NEXIUM use. (4) ------------------------WARNINGS AND PRECAUTIONS----------------• Symptomatic response to NEXIUM does not preclude the presence of gastric malignancy (5.1) • Atrophic gastritis has been noted on biopsy with long-term omeprazole therapy (5.1) ------------------------------ADVERSE REACTIONS-------------------------Most common adverse reactions: Adult use (≥ 18 years of age) (incidence > 1%): • Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth (6.1) Pediatric use (1 17 years of age) (incidence > 1-2%): • Headache, diarrhea, abdominal pain, nausea, and somnolence (6.1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ---------------------------------DRUG INTERACTIONS-----------------------• NEXIUM inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin) (7) • Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time (7) • NEXIUM may reduce the plasma levels of atazanavir and nelfinavir (7) • Nexium may increase the plasma levels of saquinavir (7) • Concomitant treatment with a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure (7). ------------------------USE IN SPECIFIC POPULATIONS--------------------• Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded. (2) ----------SEE 17 FOR PATIENT COUNSELING INFORMATION--------REVISE 12/2008