Dabigatran

Administration

• Type: Anticoagulant, Direct Thrombin Inhibitor
• Dosage Forms: capsule
• Dosage Strengths: 75mg, 110mg, 150mg
• Routes of Administration: Oral
• Common Trade Names: Pradaxa

Adult Dosing

Stroke prevention in atrial fibrillation (nonvalvular)

• 150mg PO BID (CrCl >30)
• 75mg PO BID (CrCl 15-30)

DVT/PE Treatment

• 150mg PO BID after 5-10 days of parenteral anticoagulation

DVT/PE Prophylaxis (post hip replacement)

• 110mg PO on day of surgery (1-4h post-op), then 220mg PO QD x28-35 days

Pediatric Dosing

Safety/efficacy not established

Special Populations

• Pregnancy Rating: C
• Lactation risk: Infant risk cannot be ruled out
• Renal dosing:
  • Afib: 75mg BID if CrCl 15-30; avoid if CrCl <15
  • DVT/PE treatment: avoid if CrCl <30
• Hepatic dosing: No adjustment required; avoid in severe impairment
• Decrease dose if concomitant use of P-gp inhibitors (e.g., dronedarone, systemic ketoconazole) with CrCl 30-50

Contraindications

• Allergy to class/drug
• Active pathological bleeding
• Mechanical prosthetic heart valve
• CrCl <30 (DVT/PE treatment)
• Concomitant use of P-gp inhibitors with CrCl <30

Adverse Reactions

Serious

• Bleeding, severe
  • Idarucizumab (Praxbind): specific reversal agent
• Epidural/spinal hematoma
• GI hemorrhage

Common

• Dyspepsia, GI discomfort (most common reason for discontinuation)
• Easy bruising, epistaxis

Pharmacology

• Half-life: 12-17 hours (prolonged with renal impairment)
• Metabolism: Conjugation (not CYP450 dependent)
• Excretion: 80% renal
• Bioavailability: 3-7% (capsules must not be crushed or opened)

Mechanism of Action

• Direct, competitive, reversible inhibitor of free and clot-bound thrombin (factor IIa)

Comments

• Only NOAC with a specific reversal agent: Idarucizumab (Praxbind) 5g IV
• Must be stored in original packaging (sensitive to moisture)
• Cannot be crushed, chewed, or placed in feeding tubes (bioavailability changes dramatically)
• Higher rate of GI bleeding compared to warfarin; lower rate of intracranial hemorrhage
• aPTT provides qualitative assessment of anticoagulant effect; Thrombin Time (TT) is most sensitive — normal TT excludes significant drug effect
• Dialyzable (~60% removed over 2-3h)

Indications by Condition

The following table is automatically generated from disease/condition pages across WikEM.

Indication	Dose	Context	Route	Population
Atrial fibrillation (main)	150 mg BID (reduced: 75 mg BID if CrCl 15-30)	Anticoagulation (NOAC)	PO	Adult

See Also

• Dabigatran reversal
• Idarucizumab
• Anticoagulant reversal for life-threatening bleeds
• Procedures in patients with coagulopathies
• Atrial fibrillation (main)