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NEXIUM provides a continuum of care from hospital to home. Flexible administration options include
NEXIUM I.V. for Injection
NEXIUM for Delayed-Release Oral Suspension
NEXIUM Delayed-Release Capsules
In two studies, NEXIUM I.V. demonstrated acid control
NEXIUM I.V. provided faster and more pronounced acid control than pantoprazole I.V.
Greater number of hours with pH > 4 after dosing with NEXIUM I.V. 40 mg vs pantoprazole I.V. 40 mg when both given by 15-minute infusion (11.8 vs 5.6 hours, respectively; P <0.0001)2
Greater number of hours with pH > 4 after dosing with NEXIUM I.V. 40 mg given by 15-minute infusion vs pantoprazole I.V. 40 mg when both given by 15-minute bolus (11.8 vs 7.2 hours, respectively; P <0.001)2
Data from a randomized, open-label, 3-way crossover study comparing pharmacodynamic parameters in healthy subjects treated with NEXIUM I.V. 40 mg, pantoprazole I.V. 40 mg, both by 15-minute infusion, and pantoprazole I.V. 40 mg given as a 5-minute bolus injection. There was a washout period of at least 14 days between each treatment2
Adapted from Hartmann et al, 2007.
Proven acid control with NEXIUM I.V. vs NEXIUM oral: impressive mean duration with intragastric pH >4
Day 1: 10.1 hours with NEXIUM I.V. 40 mg vs 8.8 hours with NEXIUM oral 40 mg3
Day 5: 15.9 hours with NEXIUM I.V. 40 mg vs 15.3 hours with NEXIUM oral 40 mg3
Data from a randomized, double-blind, 2-way crossover study comparing pharmacodynamic parameters in healthy subjects treated for 5 days with at least a 13-day washout period. All infusions administered over a period of 30 minutes.
NEXIUM 40 mg and NEXIUM 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE.
Maintenance of Healing of EE
NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE. Controlled studies did not extend beyond 6 months.
Symptomatic GERD
NEXIUM 20 mg is indicated for the short-term treatment (4 to 8 weeks) 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.
Effectiveness has not been demonstrated in patients less than 1 year of age. Safety and effectiveness for other pediatric uses have not been established.
Important Safety Information
NEXIUM® (esomeprazole magnesium) 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
Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. 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 NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced
NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
NEXIUM may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.
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
(PDF – 303 KB) for NEXIUM.
