Approved Uses
Healing of Erosive Esophagitis (EE)
NEXIUM oral 40 mg and NEXUM 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 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.
Effectiveness has not been demonstrated in patients less than 1 year of age. Safety and effectiveness for other pediatric uses have not been established.
Risk Reduction of NSAID-associated Gastric Ulcer
NEXIUM 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 to be at risk due to their age (≥60 years) and/or documented history of gastric ulcers. Controlled studies did not extend beyond 6 months.
Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy (NEXIUM plus amoxicillin and clarithromycin): NEXIUM, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H pylori. Eradication of H pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
NEXIUM is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
NEXIUM® I.V. (esomeprazole sodium) for Injection
NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of adult GERD patients with a history of erosive esophagitis (EE) as an alternative to oral therapy when therapy with NEXIUM Delayed-Release Capsules is not possible or appropriate.
Treatment with NEXIUM I.V. should be discontinued as soon as the patient is able to continue treatment with NEXIUM Delayed-Release Capsules.
Important Safety Information
- NEXIUM and NEXIUM I.V. are contraindicated in patients with known hypersensitivity to any component of the formulations or to substituted benzimidazoles.
- In adult patients, the most frequently reported adverse events (AEs) with NEXIUM include headache, diarrhea, and abdominal pain. Injection site reactions have also been reported with NEXIUM I.V.
- 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 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 and NEXIUM I.V. 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 see the full Prescribing Information for each product.
PRESCRIBING CONSIDERATIONS for H pylori eradication with NEXIUM
CLARITHROMYCIN PRESCRIBING CONSIDERATIONS
Because of the risk of potentially serious drug interactions, concomitant administration of clarithromycin with pimozide is contraindicated. Clarithromycin is contraindicated in patients with a known hypersensitivity to any macrolide antibiotic. Clarithromycin may elevate serum digoxin concentrations. Patients should be carefully monitored while taking clarithromycin and digoxin concomitantly.
WARNING: CLARITHROMYCIN SHOULD NOT BE USED IN PREGNANT WOMEN EXCEPT IN CLINICAL CIRCUMSTANCES WHERE NO ALTERNATIVE THERAPY IS APPROPRIATE. IF PREGNANCY OCCURS WHILE TAKING CLARITHROMYCIN, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. (See WARNINGS in Prescribing Information for clarithromycin.)
- Amoxicillin is contraindicated in patients with a known hypersensitivity to any penicillin.
- Eradication of H pylori reduces the risk of duodenal ulcer recurrence. In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
- NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.
- Consult complete Prescribing Information for clarithromycin and amoxicillin.
- The most frequently reported drug-related AEs for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%).
- In adults, the most frequently reported AEs with NEXIUM include headache, diarrhea, and abdominal pain.
- Symptomatic response to therapy does not preclude the presence of gastric malignancy.
Please click here for the full Prescribing Information 
(PDF – 303 KB) for NEXIUM.
Please click here for the full Prescribing Information (PDF – 82 KB) for NEXIUM I.V.
