Does Dabigatran Etexilate Mesylate Interact with Ketoconazole?
CDI records a moderate classification for Dabigatran Etexilate Mesylate and Ketoconazole. The stored summary is: In patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dosage of PRADAXA to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. 7.3 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery In patients with CrCl ≥ 50 mL/min who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of PRADAXA and the P-gp inhibitor by several hours. Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This record was extracted from drug labeling through openFDA. NIH/NLM RxNorm is used for drug identities. The summary and severity classification are CDI's processed information, not a verbatim source quotation. Product, route, and patient circumstances matter.
- Severity
- Moderate
- Ketoconazole Class
- Azole Antifungal
- Management
- Monitor for effects
- Data Source
- U.S. FDA via OpenFDA
What To Tell Your Doctor or Pharmacist
If you are taking Dabigatran Etexilate Mesylate and your doctor is considering prescribing Ketoconazole (or vice versa), make sure to:
- Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
- Ask whether the benefits of combining these medications outweigh the risks for your specific situation
- Ask what symptoms to watch for that would indicate the interaction is causing problems
- Ask whether any dosage adjustments are needed
- Never stop or change either medication without first consulting your healthcare provider