From the Guidelines
Pradaxa (dabigatran) for atrial fibrillation is typically prescribed at 150 mg taken twice daily for most patients, with a reduced dose of 110 mg twice daily recommended for elderly patients (age 80 and above) or those with increased bleeding risk, as well as patients with moderate kidney impairment (creatinine clearance 30-50 mL/min) 1. The recommended dosage is based on the patient's individual risk factors and kidney function.
- For patients with severe renal impairment (creatinine clearance 15-30 mL/min), a dose of 75 mg twice daily may be considered, but its safety and effectiveness have not been established 1.
- The dosage should be adjusted based on the patient's kidney function, with a creatinine clearance of 30-50 mL/min requiring a reduced dose of 110 mg twice daily 1.
- It is essential to take Pradaxa with a full glass of water, with or without food, at approximately the same times each day to maintain consistent blood levels.
- Patients should never stop taking Pradaxa without consulting their doctor, as this could increase stroke risk.
- Pradaxa works as a direct thrombin inhibitor to prevent blood clots that can cause strokes in people with atrial fibrillation, and unlike warfarin, it does not require regular blood monitoring but does need kidney function assessment before starting and periodically during treatment 1.
From the FDA Drug Label
2.2 Recommended Dabigatran Etexilate Capsules Dose for Adults IndicationDosage Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF CrCl >30 mL/min: 150 mg twice daily CrCl 15 to 30 mL/min: 75 mg twice daily CrCl <15 mL/min or on dialysis: Dosing recommendations cannot be provided CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: Reduce dose to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration
The recommended dosage of Pradaxa (dabigatran) for atrial fibrillation (AFib) is:
- 150 mg twice daily for patients with creatinine clearance (CrCl) >30 mL/min
- 75 mg twice daily for patients with severe renal impairment (CrCl 15 to 30 mL/min)
- No dosing recommendations can be provided for patients with CrCl <15 mL/min or on dialysis 2
From the Research
Recommended Dosage of Pradaxa (Dabigatran) for Atrial Fibrillation (AFib)
The recommended dosage of Pradaxa (dabigatran) for atrial fibrillation (AFib) is:
- 150 mg twice daily, as shown in studies 3, 4, 5, 6, 7 Some key points to consider:
- Dabigatran 150 mg twice daily has been shown to be effective in preventing stroke and systemic embolism in patients with AFib 4, 7
- This dosage has been associated with lower rates of intracranial bleeding compared to warfarin 4, 6
- However, it may be associated with a higher rate of gastrointestinal bleeding compared to warfarin 4, 6
- The incidence of hepatotoxicity did not significantly differ across treatment groups 3, 4
Patient-Specific Considerations
When choosing a dosage for a patient with AFib, consider the following:
- Patients with a high risk of embolism and a low risk of bleeding may be suitable for dabigatran 150 mg twice daily 5
- Patients with a higher risk of bleeding may be considered for apixaban 5 mg twice daily instead 5
- Older patients and those with kidney disease may have higher gastrointestinal bleeding rates with dabigatran 6