Dabigatran
PRADAXA
Pronunciation: da-bi-GAT-ran (pra-DAX-a)
“The Big-a-Tron’s Prada”
What it isDirect thrombin inhibitor; atrial fibrillation and VTE.
Why this oneIt has a specific reversal agent, idarucizumab, which acts within minutes.
What limits itDyspepsia is common, and the capsules must not be opened. Renally cleared, so it is the DOAC least suited to CKD; P-gp interactions matter.
FDA-approved for
- stroke prevention in AF (2010)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Nonvalvular AF — reduce stroke/systemic embolism risk | Adults, CrCl >30 mL/min | 150 mg BID | 150 mg BID | |
| Nonvalvular AF — reduce stroke/systemic embolism risk | Adults, CrCl 15–30 mL/min | 75 mg BID | 75 mg BID | |
| Treatment of DVT/PE | Adults, CrCl >30 (after 5–10 d parenteral anticoagulant) | 150 mg BID | 150 mg BID | |
| Reduce risk of recurrence of DVT/PE | Adults, CrCl >30 | 150 mg BID | 150 mg BID | |
| DVT/PE prophylaxis after hip replacement surgery | Adults, CrCl >30 | 110 mg day 1, then 220 mg QD | 220 mg QD | |
| Treatment / recurrence reduction of VTE | Pediatrics 8–<18 yr (after ≥5 d parenteral) | Weight-based BID (75–260 mg per Table 1) |
Renal Severe (CrCl 15–30): 75 mg BID for AF; CrCl ≤30 or dialysis: no dosing recommendation for DVT/PE/hip; reduce or avoid with concomitant P-gp inhibitors per renal function
Hepatic Undefined
Do not substitute dosage forms mg-to-mg and do not combine more than one dosage form to reach the total dose
Instructions
- Swallow capsules whole with a full glass of water; do not break, chew, or empty contents
- Take with food if GI distress occurs
- Missed dose: take same day if ≥6 h before next dose; do not double
- If discontinued for a reason other than bleeding or completed therapy, consider alternative anticoagulant
Available strengths
- cap 75, 110, 150 mg
- pellet 20, 30, 40, 50, 110, 150 mg
- pellets 20, 30, 40, 50, 110, 150 mg/packet
Contraindications
- Active pathological bleeding
- Mechanical prosthetic heart valve
Cautions
- Serious/fatal bleeding — risk increased with renal impairment and concomitant antithrombotics
- Spinal/epidural hematoma with neuraxial procedures
- Not recommended with bioprosthetic heart valves
- Not recommended in triple-positive antiphospholipid syndrome
- P-gp inducers reduce and inhibitors increase dabigatran exposure
Adverse reactions
- Bleeding
- Gastrointestinal reactions (dyspepsia, gastritis-like symptoms)
Pregnancy Insufficient data; anticoagulant use carries risk of maternal/fetal hemorrhage
Lactation Breastfeeding not recommended
Cost
Generic entry2022
⚠ BOXED WARNINGS
- Premature discontinuation increases thrombotic risk
- Spinal or epidural hematoma
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityMajor bleeding; renal function, age and interacting drugs materially influence risk.
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