In drug-drug interaction studies, NEXIUM showed
no clinically relevant interactions with these commonly
prescribed medications that use the same metabolic
pathway as NEXIUM
| amoxicillin | diazepam | quinidine |
| clarithromycin | phenytoin | warfarin |
Postmarketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. 14 Patients treated with proton pump inhibitors and warfarin concomitantly 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). For more information, see accompanying full Prescribing Information.
Common adverse events with NEXIUM
- In comparative clinical trials, the most frequently occurring adverse events were headache and diarrhea for patients treated with NEXIUM
- Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients treated with NEXIUM
Symptomatic response to therapy does not preclude the presence of gastric malignancy.
The safety and tolerability of NEXIUM have been
well established
- The safety of NEXIUM was evaluated in over 10,000 patients (aged 18-84 years) during worldwide clinical trials
- In over 1000 patients treated with NEXIUM for up to 6-12 months, the prevalence of ECL cell hyperplasia increased with time and dose, which is a finding consistent with the pharmacologic action of a proton pump inhibitor. No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa
- Atrophic gastritis has been noted occasionally in gastric corpus biopsies from
patients treated long-term with omeprazole, of which NEXIUM is an enantiomer - Clinical studies did not extend beyond 12 months; controlled studies did not extend beyond 6 months
- NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
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
