Adults

Non-valvular Atrial Fibrillation: 150 mg orally twice daily. DVT/PE Treatment: 150 mg orally twice daily, after 5-10 days of initial parenteral anticoagulant therapy.

Elderly

For patients 80 years or older, or with high bleeding risk, a dose of 110 mg twice daily may be considered. Renal function should be assessed.

Renal_impairment

CrCl 30-50 mL/min: 150 mg twice daily. CrCl 15-30 mL/min: 75 mg twice daily. Not recommended for CrCl <15 mL/min.

Onset

Anticoagulant effect observed within 0.5-2 hours.

Excretion

Approximately 80% of the dose is eliminated unchanged via renal excretion. The remainder is eliminated via biliary excretion.

Half life

The terminal elimination half-life is approximately 12-17 hours at steady state, extended in patients with renal impairment.

Absorption

Rapidly absorbed after oral administration of the prodrug dabigatran etexilate, which is then hydrolyzed to the active dabigatran. Absolute bioavailability is approximately 6.5%. Peak plasma concentrations reached within 0.5 to 2 hours.

Metabolism

Dabigatran etexilate is a prodrug that is rapidly and completely converted to the active dabigatran by esterase-catalyzed hydrolysis in the plasma and liver. Dabigatran itself undergoes minimal metabolism (glucuronidation) and does not involve the cytochrome P450 system.

P-gp Inducers (e.g., Rifampicin)

Decreased dabigatran exposure. Concomitant use should generally be avoided.

P-gp Inhibitors (e.g., Amiodarone, Verapamil, Quinidine, Ketoconazole, Dronedarone)

Increased dabigatran exposure and bleeding risk. Dose adjustments or avoidance may be necessary.

Other Anticoagulants (e.g., Warfarin, Heparin), Antiplatelet Agents (e.g., Aspirin, Clopidogrel), NSAIDs, SSRIs/SNRIs

Increased risk of bleeding.