Dabigatran Etexilate Mesylate is a direct thrombin inhibitor indicated:

• To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
• For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have received 5–10 days of parenteral anticoagulation.
• To reduce the risk of recurrence of DVT and PE in previously treated patients.
• For the prevention of DVT and PE in patients undergoing hip replacement surgery.

Dabigatran and its acyl glucuronide metabolites act as competitive, direct thrombin inhibitors. By inhibiting thrombin (a serine protease responsible for converting fibrinogen to fibrin in the coagulation cascade), they prevent clot formation. These active components inhibit both free and clot-bound thrombin, as well as thrombin-induced platelet aggregation.

Reduction in the Risk of Stroke and Systemic Embolism in Patients with 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.

Treatment of 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 prior treatment.

Prophylaxis of DVT and PE Following Hip Replacement Surgery: For patients with CrCl >30 mL/min: 110 mg orally on the first day, followed by 220 mg once daily. Dabigatran Etexilate Mesylate should be temporarily discontinued prior to invasive or surgical procedures when possible, and restarted promptly afterward.

Pediatric Use: Safety and effectiveness of Dabigatran Etexilate in pediatric patients have not been established.

Geriatric Use: In the RE-LY study, 82% of patients were aged 65 years or older and 40% were 75 years or older. Although the risk of stroke and bleeding increases with age, the overall benefit-risk profile remains favorable across all age groups.

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: Concomitant use of Dabigatran Etexilate with P-gp inducers (e.g., rifampin) decreases dabigatran exposure and should generally be avoided.

Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism: Avoid using Dabigatran Etexilate with P-gp inhibitors in patients with CrCl <50 mL/min.

Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism Following Hip Replacement Surgery: In patients with CrCl ≥50 mL/min receiving P-gp inhibitors (such as ড্রোনেডারোন বা সিস্টেমিক কেটোকোনাজল), it may be useful to separate the administration times of dabigatran and the P-gp inhibitor by several hours. Avoid coadministration in patients with CrCl <50 mL/min.

Dabigatran Etexilate is contraindicated in patients with active pathological bleeding, a history of severe hypersensitivity reactions to Dabigatran Etexilate, or in those with mechanical prosthetic heart valves.

Premature discontinuation of Dabigatran Etexilate may increase the risk of thrombotic events. It also increases the risk of bleeding and may cause serious, sometimes fatal, hemorrhage. Common adverse effects include dyspepsia, stomach discomfort or burning, and abdominal pain. In some cases, Dabigatran Etexilate may cause allergic reactions.

 safety of Dabigatran Etexilate during pregnancy has not been established. Breastfeeding is not recommended while receiving treatment with Dabigatran Etexilate.

Premature discontinuation of Dabigatran Etexilate increases the risk of thrombotic events. It also increases the risk of bleeding and may lead to serious or even fatal hemorrhage. Epidural or spinal hematomas may develop in patients receiving Dabigatran Etexilate who undergo neuraxial anesthesia or spinal puncture, potentially resulting in long-term or permanent paralysis. Dabigatran Etexilate is contraindicated in patients with mechanical prosthetic heart valves. Concomitant use with P-gp inducers (e.g., rifampin) reduces dabigatran exposure and should generally be avoided. In patients with triple-positive antiphospholipid syndrome, Dabigatran Etexilate may increase the risk of thrombosis.

Accidental overdose may result in bleeding complications. If bleeding occurs, appropriate supportive treatment should be started, Dabigatran Etexilate should be discontinued, and the source of bleeding should be identified. A specific reversal agent (idarucizumab) is available.

Anticoagulants, Antiplatelet drugs, Fibrinolytics (Thrombolytics)

Store in a dry place at a temperature not exceeding 30°C. Protect from light and moisture.