Dabigatran and Ketoconazole (Systemic)

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Ketoconazole can increase the blood levels and effects of dabigatran. Combining these medications may increase the risk of anemia and bleeding complications. Let your doctor know if you have kidney disease, as you may need a dose adjustment of dabigatran, or you may not be able to take the medication at all. Call your doctor promptly if you experience paleness, fatigue, dizziness, fainting, unusual bleeding or bruising, swelling, vomiting, blood in your urine or stools, headache, or weakness during treatment with these medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

MONITOR CLOSELY: Coadministration with potent inhibitors of P-glycoprotein such as ketoconazole may significantly increase the bioavailability of dabigatran following oral administration of dabigatran etexilate, which is a substrate of the efflux transporter. In pharmacokinetic studies, dabigatran peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 135% and 138%, respectively, after a single ketoconazole dose of 400 mg, and 149% and 153%, respectively, after multiple daily ketoconazole doses of 400 mg.

MANAGEMENT: Caution is advised if dabigatran is used in combination with ketoconazole. Pharmacologic response to dabigatran should be monitored more closely whenever ketoconazole is added to or withdrawn from therapy, and the dabigatran dosage adjusted as necessary. Patients should be monitored for the development of anemia and bleeding complications during coadministration. In patients with moderate renal impairment (CrCl 30 to 50 mL/min), concomitant use with ketoconazole can be expected to produce dabigatran exposure similar to that observed in severe renal impairment. Therefore, a reduction in the dabigatran dosage to 75 mg twice daily should be considered. The use of dabigatran in combination with ketoconazole in patients with severe renal impairment (CrCl 15 to 30 mL/min) should be avoided.

Dabigatran

Generic Name: dabigatran

Brand name: Pradaxa

Synonyms: Dabigatran Etexilate

What is Dabigatran?

Ketoconazole (Systemic)

Generic Name: ketoconazole

Brand name: Nizoral

Synonyms: Ketoconazole

What is Ketoconazole (Systemic)?