Dabigatran ve Dronedaron etkileşimi

Avoid use of PRADAXA Capsules and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) [see Drug Interactions (7.1) and Use in Specific Populations (8.6) ] .

Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Avoid use of PRADAXA Capsules and concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see Drug Interactions (7.2) and Use in Specific Populations (8.6) ] .

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery Avoid use of PRADAXA Capsules and concomitant P-gp inhibitors in patients with CrCl < 50 mL/min [see Drug Interactions (7.3) and Use in Specific Populations (8.6) ] .

P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid ( 7 )

P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended ( 7 )

In patients with severe renal impairment (CrCL 15–30 mL/min), concomitant use of dronedarone with dabigatran should be avoided.

Dabigatran Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter [see Clinical Pharmacology (12.3) ] .

In patients with moderate renal impairment (CrCL 30–50 mL/min), reduce the dose of dabigatran to 75 mg twice daily when concomitantly administered with dronedarone.

More patients experienced clinically significant INR elevations (≥5) usually within 1 week after starting dronedarone versus placebo in patients taking oral anticoagulants in ATHENA.