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Table 1 An audit checklist for dabigatran prescription

From: Impact of Pharmacists’ audit on improving the quality of prescription of dabigatran etexilate methanesulfonate: a retrospective study

Descriptions in prescribing information

Criteria

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

  1. CLcr creatinine clearance
  2. aAccording to the prescribing information of Prazaxa® [1] CLcr is recommended for evaluating renal function, but eGFR was used as an alternative when body weight was unavailable
  3. bVerapamil, amiodarone, quinidine, tacrolimus, cyclosporine, ritonavir, nelfinavir, saquinavir and others