Dronedarone · more major-labeled pairs than Dabigatran

SPL labels Dabigatran + Dronedarone as minor; Dabigatran 12 / Dronedarone 8 in that band.

Mechanism on file: Dronedarone blocks a specific protein that helps move dabigatran out of the body, which increases the amount of medicine in your blood.

FDA SPL severity: Minor

Dabigatran

Full Dabigatran label record

Direct Thrombin Inhibitor

Dronedarone

Full Dronedarone label record

Class III Antiarrhythmic

Dabigatran + Dronedarone · SPL mechanism field

Dronedarone blocks a specific protein that helps move dabigatran out of the body, which increases the amount of medicine in your blood.

Minor band excerpt · Dabigatran with Dronedarone

Dabigatran Dronedarone increases dabigatran plasma exposures by inhibiting the P-gp transporter [see Clinical Pharmacology (12.3) ] . In patients with moderate renal impairment (CrCL 30–50 mL/min), reduce the dose of dabigatran to 75 mg twice daily when concomitantly administered with dronedarone. In patients with severe renal impairment (CrCL 15–30 mL/min), concomitant use of dronedarone with dabigatran should be avoided.

Dronedarone · 9 major-labeled pairs (vs Dabigatran's 0)

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FDA Drug Labels (SPL) via openFDA. Registry display only. Not medical advice.