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Direct Oral Anticoagulant — Thrombin Inhibitor Pregnancy: Contraindicated — crosses placenta; LMWH preferred throughout pregnancy

Dabigatran (Stroke Prevention — AF)

Brand names: Pradaxa

Adult dose

Dose: 150 mg twice daily (standard); 110 mg twice daily (age ≥80, or age ≥75 with bleeding risk)
Route: Oral
Frequency: Twice daily
Max: 300 mg/day (150 mg BD)
Licensed for stroke/systemic embolism prevention in non-valvular AF and treatment/prevention of DVT/PE. RE-LY trial: 150 mg BD superior to warfarin for stroke prevention; 110 mg BD non-inferior with less major bleeding. NOT suitable for mechanical heart valves or haemodynamically significant mitral stenosis.

Paediatric dose

Route:
Seek specialist opinion — limited paediatric data. Some paediatric VTE dosing protocols exist under haematology.

Dose adjustments

Renal

Avoid if CrCl <30 mL/min. Reduce to 110 mg BD if CrCl 30–49 mL/min in AF. Monitor renal function at least annually (more frequently if elderly or intercurrent illness).

Hepatic

Avoid in hepatic impairment associated with coagulopathy.

Clinical pearls

  • Antidote: IDARUCIZUMAB (Praxbind) — 5 g IV (2 × 2.5 g), fully reverses dabigatran within minutes. Licensed for life-threatening bleeding or urgent surgery.
  • Dyspepsia is the most common reason for discontinuation — advise to take with food and consider PPI co-prescription
  • Capsules must not be opened or crushed — tartaric acid core increases local absorption; crushing alters pharmacokinetics significantly

Contraindications

  • Active bleeding
  • Mechanical prosthetic heart valve
  • Significant mitral stenosis
  • CrCl <30 mL/min
  • Severe hepatic impairment

Side effects

  • Bleeding (major risk)
  • Dyspepsia (common — due to tartaric acid core; take with food or PPI)
  • GI bleeding (higher rate than warfarin)
  • Anaemia

Interactions

  • P-gp inhibitors — amiodarone, verapamil, dronedarone (increase dabigatran levels)
  • P-gp inducers — rifampicin, carbamazepine, phenytoin (reduce dabigatran levels — avoid)
  • Aspirin/NSAIDs (increased bleeding risk)

Monitoring

  • Renal function annually (or more frequently)
  • Signs of bleeding
  • Dabigatran levels (dilute thrombin time or ecarin clotting time) if bleeding or peri-operative assessment needed

Reference: BNFc; BNF 90; RE-LY Trial (NEJM 2009); NICE NG196 (AF); MHRA DOAC Safety Update. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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