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omeprazol nexium esomeprazole

Esomeprazole (Nexium, Nexium IV) Linked to Antiretroviral Drug Interactions

On January 15, the FDA approved safety labeling revisions for esomeprazole sodium injection (Nexium IV, AstraZeneca) and esomeprazole magnesium delayed-release capsules and oral suspension (Nexium, AstraZeneca) to warn of antiretroviral drug interactions.

Esomeprazole is the S-enantiomer of omeprazole, which has been reported to interact with some antiretroviral drugs. For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported.

Pharmacokinetic study data have demonstrated that multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily) produce significant decreases in nelfinavir and M8 exposure (area under the curve [AUC], 36% and 92%, respectively), maximum concentration (Cmax, 37% and 89%, respectively), and trough concentration (Cmin, 39% and 75%, respectively). With multiple doses of atazanavir (400 mg daily) and omeprazole (40 mg daily, 2 hours before atazanavir), atazanavir AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%.

Concomitant administration of omeprazole and other proton pump inhibitors with atazanavir and nelfinavir is therefore not recommended because of an expected loss of antiretroviral therapeutic effect.

For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported with an 82% increase in AUC, 75% increase in Cmax, and 106% increase in Cmin after multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily coadministered on days 11 to 15.

Patients receiving esomeprazole and saquinavir should therefore be monitored regularly for saquinavir toxicity and may require reduced doses of the protease inhibitor.

Oral esomeprazole is indicated for the treatment of symptomatic gastroesophageal reflux disease, for the healing of erosive esophagitis, to reduce the risk for nonsteroidal anti-inflammatory drug–associated gastric cancer, and for the treatment of pathologic hypersecretory conditions such as Zollinger-Ellison syndrome. It is also indicated for use in triple therapy for Helicobacter pylori eradication to reduce the risk for duodenal ulcer recurrence.

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