dabigatran and amiodarone

Amiodarone inhibits the P-glycoprotein (P-gp) efflux transporter. Dabigatran etexilate is a substrate of P-gp, which mediates its intestinal absorption and renal tubular secretion. Inhibition of P-gp by amiodarone increases dabigatran plasma concentrations.

Increased dabigatran exposure raises the risk of bleeding, including gastrointestinal and intracranial haemorrhage. Patients may experience prolonged bleeding, epistaxis, or anaemia. The effect is more pronounced in patients with renal impairment.

If coadministration is necessary, reduce the dabigatran dose to 150 mg daily for patients with creatinine clearance 30-50 mL/min. For other patients, consider dose reduction or increased monitoring for bleeding. Avoid in severe renal impairment. Alternative anticoagulants should be considered.

Well-established. The interaction is documented in the product information for dabigatran and in multiple pharmacokinetic studies. Guidelines recommend caution and dose adjustment.