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DEXILANT (dexlansoprazole) Product Information Updated Regarding Coadministration with Plavix (clopidogrel bisulfate)
Date:11/17/2011

cs of clopidogrel in healthy subjects. The study showed that the area under the curve (AUC) of the active metabolite of clopidogrel was reduced by approximately 9 percent (mean AUC ratio was 91 percent, with 90 percent CI of 86-97 percent) when DEXILANT was coadministered compared to administration of clopidogrel alone.

Pharmacodynamic parameters were also measured and demonstrated that the change in inhibition of platelet aggregation (induced by 5 mcM ADP) was related to the change in the exposure to clopidogrel active metabolite. The clinical significance of this finding is not clear. These results were presented at the American College of Cardiology (ACC) 2011 60th Annual Scientific Session in April 2011.

Takeda worked with the FDA to determine the appropriate information to be included in the revised DEXILANT product labeling. This information can be found in the labeling's Drug Interactions and Clinical Pharmacology sections. The Drug Interactions section specifically states that no dose adjustment of Plavix is necessary when administered with an approved dose of DEXILANT.

"We are pleased to add this information into the DEXILANT labeling enabling us to provide a clearer understanding for health care prescribers about the co-administration of DEXILANT and Plavix," said Gilles Delecoeuillerie, M.D., Ph.D., executive medical director, Medical & Scientific Affairs, Gastroenterology and Internal Medicine, Takeda. "Takeda conducted this study to further understand how DEXILANT may interact with clopidogrel and to ensure that patients with GERD, who are treated with both medications, have the most up to date coadministration information."

About DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed release capsules

DEXILANT is a PPI, which decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. DEXIL
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SOURCE Takeda Pharmaceuticals North America, Inc.
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