Drug Interaction Report

MONITOR: Coadministration with inhibitors of P-glycoprotein (P-gp) such as carvedilol may increase the plasma concentration of dabigatran etexilate, a substrate of the efflux transporter. When digoxin (0.25 mg once a day), a P-gp probe substrate, was administered with carvedilol (25 mg once a day) in hypertensive patients for 14 days, digoxin steady state AUC and trough concentrations increased by 14% and 16%, respectively. According to some authorities, digoxin exposure has increased by up to 56% when given with carvedilol in various studies involving healthy subjects and patients with heart failure.

MANAGEMENT: Product labeling advises that use of dabigatran with P-gp inhibitors in patients with severe renal impairment (CrCl less than 30 mL/min) should be avoided. In patients taking dabigatran for the treatment or prophylaxis of deep venous thrombosis (DVT) or pulmonary embolism (PE), use of dabigatran with P-gp inhibitors in moderate renal impairment (CrCl 30 to 50 mL/min) should be avoided.