Product labeling drug interaction recommendations for dabigatran46-48
| Drug . | United States . | Canada . | Europe . |
|---|---|---|---|
| Pharmacokinetic inducer interactions | |||
| p-gp inducer | Should generally be avoided | Not recommended; caution is advised if used | Avoid |
| Pharmacokinetic inhibitor interactions | |||
| Amiodarone | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | No dose adjustment required | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication |
| Clarithromycin | No dose adjustment required | No dose adjustment required | Clinically relevant interaction cannot be excluded; close monitoring should be exercised |
| Dronedarone | AF indication: reduce dabigatran dose to 75 mg twice daily if CrCl 30-50 mL/min | Avoid use | Contraindicated |
| Keoconazole | AF indication: reduce dabigatran dose to 75 mg twice daily if CrCl 30-50 mL/min | Contraindicated | Contraindicated |
| Quinidine | No dose adjustment required | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | No dose adjustment required |
| Verapamil | No dose adjustment required | For AF and VTE treatment indications, give dabigatran at least 2 h before verapamil; caution should be exercised; close clinical surveillance is required | Reduce dabigatran dose to 110 mg twice daily |
| Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | |||
| Renal function | Avoid use of p-gp inhibitors if CrCl 15-30 mL/min | None | None |
| VTE treatment and prophylaxis: avoid use of p-gp inhibitors if CrCl < 50 mL/min | |||
| Drug . | United States . | Canada . | Europe . |
|---|---|---|---|
| Pharmacokinetic inducer interactions | |||
| p-gp inducer | Should generally be avoided | Not recommended; caution is advised if used | Avoid |
| Pharmacokinetic inhibitor interactions | |||
| Amiodarone | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | No dose adjustment required | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication |
| Clarithromycin | No dose adjustment required | No dose adjustment required | Clinically relevant interaction cannot be excluded; close monitoring should be exercised |
| Dronedarone | AF indication: reduce dabigatran dose to 75 mg twice daily if CrCl 30-50 mL/min | Avoid use | Contraindicated |
| Keoconazole | AF indication: reduce dabigatran dose to 75 mg twice daily if CrCl 30-50 mL/min | Contraindicated | Contraindicated |
| Quinidine | No dose adjustment required | Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | No dose adjustment required |
| Verapamil | No dose adjustment required | For AF and VTE treatment indications, give dabigatran at least 2 h before verapamil; caution should be exercised; close clinical surveillance is required | Reduce dabigatran dose to 110 mg twice daily |
| Reduce dabigatran dose to 150 mg daily for VTE orthopedic surgery prophylaxis indication | |||
| Renal function | Avoid use of p-gp inhibitors if CrCl 15-30 mL/min | None | None |
| VTE treatment and prophylaxis: avoid use of p-gp inhibitors if CrCl < 50 mL/min | |||
AF, atrial fibrillation; CrCl, creatinine clearance; VTE, venous thromboembolism.