Using Pradaxa - Dose adjustments

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How do I identify and evaluate risk factors for bleeding?

Factors that may increase bleeding risk are shown in the table. Patients with an increased bleeding risk should be closely observed clinically (looking for signs of bleeding or anemia). Dose adjustment should be decided at the discretion of the physician, following assessment of the potential benefit and risk to an individual patient.

A coagulation test may help to identify patients with an increased bleeding risk caused by excessive Pradaxa exposure. When excessive Pradaxa exposure is identified in patients at high risk of bleeds, a dose of 220 mg given as one 110 mg capsule twice daily is recommended. When clinically relevant bleeding occurs, treatment should be interrupted.1

Summary of factors that may increase haemorrhagic risk*

An image showing the pharmacodynamic and pharmacokinetic factors of Pradaxa (Dabigatran)
  1. Pradaxa Summary of Product Characteristics 2016. Boehringer Ingelheim.