Clarithromycin and Dabigatran interaction

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 )

Oral Anticoagulants: There is a risk of serious hemorrhage and significant elevations in INR and prothrombin time when clarithromycin is co-administered with warfarin.

Monitor INR and prothrombin times frequently while patients are receiving clarithromycin tablets and oral anticoagulants concurrently [see Drug Interactions ( 7 )] .

Oral Anticoagulants: Warfarin Use With Caution Oral anticoagulants: Spontaneous reports in the postmarketing period suggest that concomitant administration of clarithromycin and oral anticoagulants may potentiate the effects of the oral anticoagulants.

Prothrombin times should be carefully monitored while patients are receiving clarithromycin and oral anticoagulants simultaneously [see Warnings and Precautions ( 5.4 )] .