Dabilong Capsules (Dabigatran Etexilate)

• Composition :
  Each capsule contains Dabigatran 75/110/150 mg.
• Indications :
  For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation, prevention of venous thromboembolic events in patients who have undergone orthopedic surgery. Treatment of acute deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and prevention of related death, prevention of recurrent deep vein thrombosis (DVT) and /or pulmonary embolism (PE) and related death.
• Pharmacodynamics :
  Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors which prevent the development of a thrombus.
• Dosage and administration :
  Non-valvular Atrial Fibrillation: For patients with CrCl >30 mL/min: 150 mg orally, twice daily, For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily, DVT and PE: For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation, Reduction in the Risk of Recurrence of DVT and PE. For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment, DVT and PE Following Hip Replacement Surgery: For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily, Discontinue Dabigatran temporarily before invasive or surgical procedures, then restart promptly.
• Contraindications :
  Contraindicated in active pathological bleeding, dabigatran hypersensitivity and mechanical prosthetic heart valve.
• Precautions and warnings :
  Increased risk of thrombotic events, risk of bleeding, spinal/epidural anesthesia or puncture, bioprosthetic heart valves-use is not recommended. Temporary discontinuation: Avoid lapses in therapy to minimize risk of stroke.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy category C. There are no adequate and well-controlled studies established for safety and efficacy in this population. It is not known whether dabigatran is excreted in human milk. Hence, caution should be exercised on administering to nursing women. Safety and effectiveness of dabigatran in pediatric patients have not been established.
• Drug interactions :
  Concomitant use with P-gp inducers (e.g. rifampin), P-gp inhibitor (e.g. dronedarone and systemic ketoconazole) and in patients with CrCl <50 mL/min should be avoided.
• Adverse reactions :
  The most common adverse events are gastritis-like symptoms and bleeding.
• Therapy Area :
  Anti-Coagulants