November 17, 2011
Dexilant Labeling Updated with Plavix Coadministration InformationTakeda announced that it has updated the product labeling for Dexilant (dexlansoprazole) to include information demonstrating that Dexilant had no clinically important effect on exposure to the active metabolite of clopidogrel (Plavix; Bristol-Myers Squibb and Sanofi) or clopidogrel-induced platelet inhibition. The labeling indicates that no dose adjustment of clopidogrel is necessary when administered with an approved dose of Dexilant.
The effect of Dexilant on the pharmacokinetics and pharmacodynamics of clopidogrel was evaluated in a randomized, open-label, two-period, crossover study. The study showed that the area under the curve (AUC) of the active metabolite of clopidogrel was reduced by approximately 9% (mean AUC ratio was 91% [90% CI 86–97%] when Dexilant was coadministered compared to administration of clopidogrel alone.
Dexilant is indicated for the treatment of erosive esophagitis (EE) and heartburn related to non-erosive gastroesophageal reflux disease, as well as maintenance of healing of EE. Plavix is indicated for the reduction of atherosclerotic events in: recent myocardial infarction (MI) or stroke, peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) or ST-segment elevation acute MI.
For more information call (877) 825-3327 or visit www.dexilant.com.