Key Product Information
Pradaxa is the FDA-approved brand name under which dabigatran etexilate is marketed in the United States and internationally 1, 2, 3, 4
The medication is formulated as dabigatran etexilate, which is an orally absorbable prodrug that converts to the active form dabigatran after absorption 5, 1
Pradaxa is available in 75 mg and 150 mg capsule strengths for oral administration 1
Clinical Context
Pradaxa is a direct thrombin inhibitor (Factor IIa inhibitor) that provides predictable anticoagulation without requiring routine laboratory monitoring, unlike warfarin 2, 6, 7
The drug is approved for multiple indications including reduction of stroke risk in non-valvular atrial fibrillation, treatment of deep venous thrombosis and pulmonary embolism, and prevention of venous thromboembolism after orthopedic surgery 1, 5
Pradaxa was approved by the FDA in October 2010 for stroke prevention in patients with non-valvular atrial fibrillation 6
Important Prescribing Considerations
The medication must be stored in its original bottle to protect from moisture and should be used within 4 months of opening 1
Patients should not open capsules or place them in pill organizers, as this compromises the drug's stability 1
Renal function is critical for dosing decisions, as dabigatran is primarily eliminated renally (80% unchanged) with dose adjustments required for moderate renal impairment 5, 4, 7