NEXIUM is a proton pump inhibitor indicated for the following:

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Treatment of gastroesophageal reflux disease (GERD). (1.1)

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Risk reduction of NSAID-associated gastric ulcer. (1.2)

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H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3)

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Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. (1.4)

See full prescribing information for administration options. (2)

Patients with severe liver impairment-do not exceed dose of 20 mg. (2)

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NEXIUM Delayed-Release Capsules: 20 mg and 40 mg. ( 3)

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NEXIUM For Delayed-Release Oral Suspension: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg. ( 3)

Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred). (4)

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Symptomatic response does not preclude the presence of gastric malignancy. ( 5.1)

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Atrophic gastritis has been noted with long-term omeprazole therapy. ( 5.2)

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Acute interstitial nephritis has been observed in patients taking PPIs. (5.3)

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Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.4)

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PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. (5.5)

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Avoid concomitant use of NEXIUM with clopidogrel. (5.6)

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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. (5.7)

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Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.8)

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Avoid concomitant use of NEXIUM with St. John’s Wort or rifampin due to the potential reduction in esomeprazole levels. ( 5.9, 7.3)

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Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. ( 5.10, 12.2)

Most common adverse reactions (6.1):

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Adults (≥ 18 years) (incidence >1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.

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Pediatric (1 to 17 years) (incidence >2%) are headache, diarrhea, abdominal pain, nausea, and somnolence.

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Pediatric (1 month to less than 1 year) (incidence 1%) are abdominal pain, regurgitation, tachypnea, and increased ALT.

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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May affect plasma levels of antiretroviral drugs – use with atazanavir and nelfinavir is not recommended; if saquinavir is used with NEXIUM, monitor for toxicity and consider saquinavir dose reduction. ( 7.1)

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May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, erlotinib, digoxin and mycophenolate mofetil). Patients treated with NEXIUM and digoxin may need to be monitored for digoxin toxicity. ( 7.2)

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Combined inhibitor of CYP2C19 and 3A4 may raise esomeprazole levels. ( 7.3)

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Clopidogrel: NEXIUM decreases exposure to the active metabolite of clopidogrel. ( 7.3)

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May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction. ( 7.3)

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Tacrolimus: NEXIUM may increase serum levels of tacrolimus. ( 7.5)

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Methotrexate: NEXIUM may increase serum levels of methotrexate. ( 7.7)

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Pregnancy: Based on animal data, may cause fetal harm. (8.1)