Pradaxa

Pradaxa Drug Interactions

dabigatran

Manufacturer:

Boehringer Ingelheim
Full Prescribing Info
Drug Interactions
The concomitant use of PRADAXA with treatments that act on haemostasis or coagulation including Vitamin K antagonists can markedly increase the risk of bleeding. See Precautions.
Dabigatran etexilate and dabigatran are not metabolized by the cytochrome P450 system and had no effects in vitro on human cytochrome P450 enzymes. Therefore related drug-drug interactions are not expected with dabigatran etexilate or dabigatran.
P-gp interactions: P-glycoprotein inhibitors: Dabigatran etexilate is a substrate for the efflux transporter P-gp. Concomitant administration of P-gp inhibitors (such as amiodarone, verapamil, quinidine, systemic ketoconazole, dronedarone, ticagrelor and clarithromycin) is expected to result in increased dabigatran plasma concentrations.
Concomitant administration of systemic ketoconazole is contraindicated.
Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery: For the concomitant use of P-gp inhibitors and dosing of PRADAXA in this indication see Dosage & Administration.
Prevention of stroke and systemic embolism in patients with atrial fibrillation with at least one additional risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack [TIA], or systemic embolism; left ventricular dysfunction): For the P-gp inhibitors listed above no dose adjustments are required for PRADAXA in this indication.
Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE): For the P-gp inhibitors listed above no dose adjustments are required for PRADAXA in this indication.
Amiodarone: Dabigatran exposure in healthy subjects was increased by 1.6 fold (+60 %) in the presence of amiodarone.
Prevention of stroke and systemic embolism in patients with atrial fibrillation with at least one additional risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack [TIA], or systemic embolism; left ventricular dysfunction): In patients in the RE-LY trial concentrations were increased by no more than 14% and no increased risk of bleeding was observed.
Verapamil: When PRADAXA (150 mg) was coadministered with oral verapamil, the Cmax and AUC of dabigatran were increased but the magnitude of this change differs, depending on timing of administration and formulation of verapamil.
Prevention of stroke and systemic embolism in patients with atrial fibrillation with at least one additional risk factor for stroke (i.e., previous ischemic stroke, transient ischemic attack [TIA], or systemic embolism; left ventricular dysfunction): In patients in the RE-LY trial concentrations were increased by no more than 21% and no increased risk of bleeding was observed.
Quinidine: Dabigatran exposure in healthy subjects was increased by 1.5 fold (+53 %) in the presence of quinidine.
Clarithromycin: Dabigatan exposure in healthy subjects was increased by about 19 % in the presence of clarithromycine without any clinical safety concern.
Ketoconazole: Dabigatran exposure was increased by 2.5 fold (+150%) after single and multiple doses of systemic ketoconazole (see Contraindications).
Dronedarone: Dabigatran exposure was increased by 2.1 fold (+114%) after single or 2.4 fold (+136%) after multiple doses of dronedarone, respectively.
Ticagrelor: Dabigatran exposure in healthy subjects was increased by 1.46 fold (+ 46%) in the presence of ticagrelor at steady state or by 1.73 fold (+73%) when a loading dose of ticagrelor was administered simultaneously with a single dose of 75 mg dabigatran etexilate.
Dabigatran steady state exposure in healthy subjects was increased by 1.26 fold (+ 26 %) in the presence of ticagrelor at steady state or by 1.49 fold (+49%) when a loading dose of ticagrelor was administered simultaneously with 110 mg dabigatran etexilate. The increase in exposure was less pronounced when the 180 mg ticagrelor loading dose was given two hours after dabigatran intake (+27%).
P- glycoprotein substrate: Digoxin: In a study performed with 24 healthy subjects, when PRADAXA was coadministered with digoxin, no changes on digoxin and no clinical relevant changes on dabigatran exposure have been observed.
P-glycoprotein inducers: After 7 days of treatment with 600 mg rifampicin qd total dabigatran AUC0-∞ and Cmax were reduced by 67% and 66% compared to the reference treatment, respectively.
The concomitant use with P-gp inducers (e.g., rifampicin) reduces exposure to dabigatran and should be avoided (see Precautions).
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