Dabigatran Etexilate
Generic Name: dabigatran etexilate
Brand Names:
Dabigatran
Dabigatran etexilate mesylate is a direct thrombin inhibitor available in 75 mg, 110 mg, and 150 mg capsule strengths with inactive ingredients including croscarmellose sodium and magnesium stearate.
Overview
Dabigatran etexilate mesylate is a direct thrombin inhibitor available in 75 mg, 110 mg, and 150 mg capsule strengths with inactive ingredients including croscarmellose sodium and magnesium stearate.
Uses
Indicated for reducing stroke and systemic embolism risk in non-valvular atrial fibrillation; treating DVT and PE after parenteral anticoagulation; reducing recurrence risk of DVT/PE; and prophylaxis of DVT/PE following hip replacement surgery in adult patients.
Dosage
Dosing varies by indication and renal function. For atrial fibrillation: 150 mg twice daily (CrCl greater than 30) or 75 mg twice daily (CrCl 15-30). Capsules must be swallowed whole with water; breaking increases exposure.
Side Effects
Most common adverse reactions include gastrointestinal effects and bleeding. Major bleeding rate comparable to warfarin at 3.47% annually; higher GI bleeding at 1.59% annually versus 1.05% with warfarin.
Interactions
Avoid P-gp inducers (rifampin). Manage P-gp inhibitor use based on renal function; dose reduction or avoidance required with severe renal impairment.
Warnings
Two critical warnings: (A) premature discontinuation increases thrombotic event risk; (B) spinal/epidural hematoma risk with neuraxial anesthesia, potentially causing permanent paralysis. Contraindicated in active pathological bleeding, serious hypersensitivity reactions, and mechanical prosthetic heart valves.
Pregnancy
Limited human data. Animal studies showed increased fetal death, bleeding, and ossification delays at exposures 2.6-8 times human levels.
Frequently Asked Questions
What is Dabigatran Etexilate used for?▼
Indicated for reducing stroke and systemic embolism risk in non-valvular atrial fibrillation; treating DVT and PE after parenteral anticoagulation; reducing recurrence risk of DVT/PE; and prophylaxis of DVT/PE following hip replacement surgery in adult patients.
What are the side effects of Dabigatran Etexilate?▼
Most common adverse reactions include gastrointestinal effects and bleeding. Major bleeding rate comparable to warfarin at 3.47% annually; higher GI bleeding at 1.59% annually versus 1.05% with warfarin.
Can I take Dabigatran Etexilate during pregnancy?▼
Limited human data. Animal studies showed increased fetal death, bleeding, and ossification delays at exposures 2.6-8 times human levels.
What are the important warnings for Dabigatran Etexilate?▼
Two critical warnings: (A) premature discontinuation increases thrombotic event risk; (B) spinal/epidural hematoma risk with neuraxial anesthesia, potentially causing permanent paralysis. Contraindicated in active pathological bleeding, serious hypersensitivity reactions, and mechanical prosthetic heart valves.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.