Product Information
 



Dosing flexibility

Before prescribing NEXIUM, clarithromycin, or amoxicillin, please see important prescribing considerations below.

*The majority of patients are healed within 4-8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered.

†Controlled studies did not extend beyond 6 months.

‡If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment
may be considered.

The most frequently reported adverse events with NEXIUM are headache, diarrhea, and abdominal pain. Symptomatic response to therapy does not preclude the presence of gastric malignancy. As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time.

PRESCRIBING CONSIDERATIONS1
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 digoxin serum 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 adverse events with NEXIUM are headache, diarrhea, and abdominal pain. The most frequently reported drug-related adverse events for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%).

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Before prescribing NEXIUM, please see accompanying full Prescribing Information

References: 1. Prescribing Information for NEXIUM. 2. Lind T, Rydberg L, Kylebäck A, et al. Esomeprazole provides improved acid control vs. omeprazole in patients with symptoms of gastro-oesophageal reflux disease. Aliment Pharmacol Ther. 2000;14:861-867. 3. Kahrilas PJ, Falk GW, Johnson DA, et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomised controlled trial. Aliment Pharmacol Ther. 2000;14:1249-1258. 4. Richter JE, Kahrilas PJ, Johnson J, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol. 2001;96(3):656-665.

§ Biaxin is a registered trademark of Abbott Laboratories.
II Orap is a registered trademark of Gate Pharmaceuticals.

 



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NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.
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