dabigatran etexilate + ketoconazole

This is a **combination of dabigatran etexilate and ketoconazole**. **Dabigatran etexilate** is an oral prodrug of dabigatran, a direct thrombin (Factor IIa) inhibitor, used as an anticoagulant for prevention and treatment of thromboembolic disorders such as non-valvular atrial fibrillation, deep vein thrombosis, and pulmonary embolism. **Ketoconazole** is an imidazole antifungal agent, strong inhibitor of cytochrome P450 enzymes CYP3A4 and P-glycoprotein (P-gp); it is sometimes used for systemic and topical fungal infections but also interacts pharmacokinetically with other drugs. **When co-administered, ketoconazole significantly increases plasma concentrations of dabigatran through P-gp inhibition, thereby markedly raising the risk of bleeding.** The combination is **strongly discouraged or contraindicated** due to the interaction risk; if given, it should only be in closely monitored exceptional circumstances[2][3][4][6].

Brand names

PradaxaNizoral

Other names

dabigatran etexilate mesylateketoconazolum