Label Changes for:

Prilosec (omeprazole magnesium) for delayed-release oral suspension and delayed-release capsules

June 2011

Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January and June 2011

 

 

June 2011  

5 WARNING AND PRECAUTIONS

5.4 Diminished Anti-platelet Activity of Clopidogrel Due to Impaired CYP2C19 Function by Omeprazole
  • 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 omeprazole, that interfere with CYP2C19 activity. Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Drug Interactions (7)]
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