Home About

DABIGATRAN

DABIGATRAN ETEXILATE

Manufacturer: AvKARE

Score: 148.0

Quick Summary

Dabigatran etexilate is a direct thrombin inhibitor used to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, treat deep vein thrombosis and pulmonary embolism, and prevent recurrence of these conditions. The drug has several key clinical findings and indications, including a reduced risk of stroke and systemic embolism, and is generally well-tolerated but can cause bleeding and other adverse reactions. Important safety information includes warnings about premature discontinuation, spinal/epidural hematoma, and bleeding risks, as well as contraindications for patients with active pathological bleeding, serious hypersensitivity reactions, or mechanical prosthetic heart valves. The main dosing recommendations vary depending on the condition being treated and patient factors such as renal function, with dose adjustments needed for patients with renal impairment. Special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use, with careful monitoring and dose adjustment recommended as needed.

Key Clinical Findings and Indications

  • Reduces risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
  • Treats deep vein thrombosis and pulmonary embolism
  • Prevents recurrence of deep vein thrombosis and pulmonary embolism
  • Reduces risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

Important Safety Information

Warning

Premature discontinuation of dabigatran increases the risk of thrombotic events, and spinal/epidural hematoma can occur in patients treated with dabigatran who are receiving neuraxial anesthesia or undergoing spinal puncture

Contraindications

  • Active pathological bleeding
  • Serious hypersensitivity reaction to dabigatran or its ingredients
  • Mechanical prosthetic heart valve

Adverse Reactions

  • Bleeding
  • Gastrointestinal adverse reactions
  • Hypersensitivity reactions

Dosing Recommendations

General Guidance

Dose adjustments needed for patients with renal impairment, with reduced doses recommended for patients with severe renal impairment

Non-valvular atrial fibrillation

Adult Dose

150 mg orally, twice daily

Pediatric Dose

Not established

Deep vein thrombosis and pulmonary embolism

Adult Dose

150 mg orally, twice daily after 5-10 days of parenteral anticoagulation

Pediatric Dose

Not established

Prevention of deep vein thrombosis and pulmonary embolism following hip replacement surgery

Adult Dose

110 mg orally, first day, then 220 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy only if potential benefit justifies potential risk to fetus
  • Limited data available on use in pregnant women

Nursing Mothers

  • Caution recommended when using in nursing mothers
  • Limited data available on use in nursing mothers

Pediatric Use

  • Not established for pediatric patients
  • Limited data available on use in pediatric patients

Geriatric Use

  • No dose adjustment recommended for geriatric patients with normal renal function
  • Careful monitoring recommended for geriatric patients with renal impairment