Descriptions in prescribing information | Criteria |
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Indication | • Prevention of strokes and systemic thromboembolic complications in patients with non-valvular atrial fibrillation |
Contraindications | • Severe renal dysfunction (CLcr < 30 mL/min or eGFR < 30 mL/min/1.73 m2a) • Active bleeding or hemorrhagic diathesis • Clinical complications associated with high-risk of bleeding (cerebral hemorrhage) within 6 months • Concomitant indwelling of spinal or epidural catheter • Concomitant oral administration of itraconazole • History of serious hypersensitivity reaction to Prazaxa® |
Instruction of dose reduction (300 mg/day to 220 mg/day) | • Moderate renal dysfunction (CLcr 30–50 mL/min or eGFR 30–50 mL/min/1.73 m2a) • Concomitant oral administration of P-glycoprotein inhibitorsb • Age ≥ 70 years • Previous history of gastrointestinal bleeding |
Instruction for timing of initiating dabigatran therapy after withdrawal of warfarin | • Dabigatran should be started after PT-INR decreases < 2.0 |