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U.S. Department of Health and Human Services

Safety

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Interaction between Esomeprazole/Omeprazole and Clopidogrel Label Change

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

November 2012

Summary View

added:

Zegerid (omeprazole/sodium bicarbonate) Powder for Oral Suspension
Zegerid (omeprazole/sodium bicarbonate) Capsules 

 

October 2012

Summary View

 

  • Nexium I.V. (esomeprazole sodium) for Injection
  • Nexium (esomeprazole magnesium) Delayed-Release Capsules and Oral Suspension
  • Prilosec (omeprazole) Delayed-Release Capsules and Oral Suspension
  • Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets
 

WARNINGS AND PRECAUTIONS

Interaction with Clopidogrel
  • Avoid concomitant use of esomeprazole/omeprazole with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole/omeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole/omeprazole, consider alternative anti-platelet therapy.
 

DRUG INTERACTIONS

Effects on Hepatic Metabolism/Cytochrome P-450 pathways
  • Clopidogrel: Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole/omeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of esomeprazole/Omeprazole with clopidogrel. When using esomeprazole/omeprazole, consider use of alternative anti-platelet therapy.

 

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