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Prescribing Information

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Treatment of Gastroesophageal Reflux Disease (GERD)
Healing of Erosive Esophagitis (EE): NEXIUM is indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE.

Maintenance of Healing of EE: NEXIUM is indicated to maintain symptom resolution and healing of EE. Controlled studies did not extend beyond 6 months.

Symptomatic GERD: NEXIUM is indicated for the treatment of heartburn and other symptoms associated with GERD.

Pediatric Use: NEXIUM is indicated for the short-term treatment (up to 8 weeks) of GERD (symptomatic GERD and healing of EE) in patients 1 to 17 years of age. Pediatric use is supported by extrapolation of results from studies that supported the approval for NEXIUM for adults and safety and pharmacokinetic studies performed in pediatric and adolescent patients. Safety and effectiveness for the treatment of symptomatic GERD in patients less than 1 year of age have not been established. Safety and effectiveness for other pediatric uses have not been established.

Important Safety Information

• NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
• In adult patients, the most frequently reported adverse events (AEs) with NEXIUM include headache, diarrhea, and abdominal pain
• In pediatric patients 1 to 17 years of age, the most frequently reported AEs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
• Symptomatic response to therapy does not preclude the presence of gastric malignancy.
• Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer
• As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other PPIs, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin)
• Concomitant use of atazanavir and PPIs is not recommended because the plasma concentrations of atazanavir are expected to substantially decrease and thereby reduce its therapeutic effect.
• NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Dosing for adults and pediatrics is provided in the Prescribing Information
• Please click here to see the full Prescribing Information (PDF – 303 KB) for NEXIUM