<p><strong>Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation</strong>: The concomitant use of Dabigatran Etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone. In patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dose of Dabigatran Etexilate to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dose adjustment of Dabigatran Etexilate. These results should not be extrapolated to other P-gp inhibitors. The concomitant use of Dabigatran Etexilate and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) should be avoided.<br />
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<strong>Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism</strong>: Avoid use of Dabigatran Etexilate and P-gp inhibitors in patients with CrCl &lt;50 mL/min.<br />
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<strong>Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery</strong>: In patients with CrCl &ge;50 mL/min who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of dabigatran and the P-gp inhibitor by several hours. The concomitant use of Dabigatran Etexilate and P-gp inhibitors in patients with CrCl &lt;50 mL/min should be avoided.</p>