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Direct Thrombin Inhibitor (DOAC)

Dabigatran (Elderly AF — DOAC)

Brand names: Pradaxa

Dabigatran is a direct oral anticoagulant (a direct thrombin inhibitor) used for stroke prevention in 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

It directly and reversibly inhibits thrombin (factor IIa), preventing the conversion of fibrinogen to fibrin and reducing clot formation.

Prescribing in practice

  • Bleeding is the main risk; it is substantially renally cleared, so assess renal function and avoid or reduce in renal impairment, especially in older patients.
  • Dyspepsia is common; a specific reversal agent, idarucizumab, is available for emergencies.
  • The capsules must be swallowed whole and must not be removed from the blister or opened, as this greatly increases drug exposure.

Monitoring

Monitor renal function and for signs of bleeding, and reassess renal function during illness or when it may deteriorate.

Counselling the patient

  • Report unusual bruising or bleeding, black stools or blood in the urine.
  • Take the capsules whole and store them in the original blister, removing one only when about to take it.

Evidence & guidelines

Non-inferior to warfarin for stroke prevention in atrial fibrillation (RE-LY) and recommended in UK guidance (NICE NG196).

Reference: RE-LY Trial (Connolly et al. NEJM 2009); REVERSE-AD Trial (Pollack et al. NEJM 2017); NICE NG196 (AF); MHRA Drug Safety Update 2011; 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.