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Direct Oral Anticoagulant / AF

Dabigatran (AF / VTE)

Brand names: Pradaxa

Used in: Atrial Fibrillation

Dabigatran is a direct oral anticoagulant (a direct thrombin inhibitor) used for stroke prevention in non-valvular atrial fibrillation and for venous thromboembolism.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

• Non-valvular Atrial Fibrillation in Adult Patients: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily ( 2.2 ) o For patients with CrCl 15 to 30 mL/min: 75 mg orally, twice daily ( 2.2 ) • Treatment of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5 to 10 days of parenteral anticoagulation ( 2.2 ) • Reduction in the Risk of Recurrence of DVT and PE in Adult Patients : o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) • Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients : o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-11-20. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Clinical monograph

How it works

Dabigatran directly and reversibly inhibits thrombin (factor IIa), preventing conversion of fibrinogen to fibrin.

Prescribing in practice

  • Capsules must be kept in the original blister/bottle and swallowed whole — do not break or recapsulate, as this greatly increases absorption.
  • It is substantially renally cleared — avoid in severe renal impairment and reduce/monitor in older patients; check renal function before and during treatment.
  • Dyspepsia is common; a specific reversal agent (idarucizumab) is available for emergencies.

Monitoring

No routine coagulation monitoring; assess renal function at baseline and at least annually (more often if impaired, elderly, or unwell).

Counselling the patient

  • Keep capsules in their original packaging and swallow whole with water.
  • Report unusual bleeding or indigestion.
  • Tell clinicians or dentists you take an anticoagulant.

Evidence & guidelines

DOACs are first-line for non-valvular AF (NICE NG196); dabigatran's AF evidence comes from RE-LY.

Reference: RE-LY Trial (Connolly et al. NEJM 2009); RE-ALIGN Trial; REVERSE-AD Trial; NICE TA249; SPC Pradaxa; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.