It 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 venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days . ? To reduce the risk of recurrence of DVT and PE in patients who have been previously treated . ? For the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery
Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics)
Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.
Non-valvular Atrial Fibrillation: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily . o For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily .Treatment of DVT and PE: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation (2.1) ? Reduction in the Risk of Recurrence of DVT and PE: o For patients with CrCl >30 mL/min: 150 mg orally, twice daily after previous treatment (2.1) ? Prophylaxis of DVT and PE Following Hip Replacement Surgery: o For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily. ? Review recommendations for converting to or from other oral or parenteral anticoagulants . ? Temporarily discontinue it before invasive or surgical procedures when possible, then restart promptly
Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: The concomitant use of Dabigatran Etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided.
Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism: Avoid use of Dabigatran Etexilate and 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 who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of dabigatran and the P-gp inhibitor by several hours. The concomitant use of Dabigatran Etexilate and P-gp inhibitors in patients with CrCl <50 mL/min should be avoided.
Active pathological bleeding ? History of serious hypersensitivity reaction to it ? Mechanical prosthetic heart valve
Gastritis-like symptoms and bleeding
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Safety and effectiveness of Dabigatran during labor and delivery have not been studied in clinical trialsLactation: Breastfeeding not recommended
Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, appropriate clinical support must be initiated, treatment with Dabigatran Etexilate should be discontinued, and the source of bleeding should be investigated. A specific reversal agent (idarucizumab) is available.
Store at temperature not exceeding 30°C in dry place. Protect from light and moisture.
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