Risk factors for gastric ulcer

Important Information

Approved Uses

Pathological Hypersecretory Conditions
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions. Dosage regimens should be adjusted to individual patient needs.

Risk Reduction of NSAID-Associated Gastric Ulcer
NEXIUM (esomeprazole magnesium) is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered at risk due to their age (≥60 years) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.

Important Safety Information
NEXIUM and NEXIUM I.V. are contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. Injection site reactions have also been reported with NEXIUM I.V.

In patients aged 12 to 17 years, the most frequently reported adverse events with NEXIUM include headache, diarrhea, abdominal pain, and nausea.

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 proton pump inhibitors, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin).

Concomitant administration of esomeprazole may reduce the plasma levels of atazanavir.

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Please see full Prescribing Information for NEXIUM.