Pradaxa Capsule

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.

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 previous treatment.

Prophylaxis of DVT and PE Following Hip Replacement Surgery: For patients with CrCl >30 mL/min: 110 mg orally first day, then 220 mg once daily. Temporarily discontinue Dabigatran Etexilate Mesylate before invasive or surgical procedures when possible, then restart promptly.

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

Geriatric Use: Of the total number of patients in the RE-LY study, 82% were 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile is favorable in all age groups.

Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation: The concomitant use of Pradaxa 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 Pradaxa 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 Pradaxa Etexilate and P-gp inhibitors in patients with CrCl <50 mL/min should be avoided.

Dabigatran Etexilate is contraindicated in patients with active pathological bleeding, patients with history of
serious hypersensitivity reaction to Dabigatran Etexilate and patients with mechanical prosthetic heart valve.

Premature discontinuation of Pradaxa Etexilate increases the risk of thrombotic events. Pradaxa Etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Common side effects of Pradaxa Etexilate include indigestion, upset stomach, or burning, stomach pain. In some people Pradaxa Etexilate can cause symptoms of an allergic reaction.

Safety has not been established during pregnancy. Breastfeeding is not recommended during treatment with Dabigatran Etexilate.

Premature discontinuation of Pradaxa Etexilate increases the risk of thrombotic events. Pradaxa Etexilate increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding. Epidural or spinal hematomas may occur in patients treated with Pradaxa Etexilate who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. The use of Pradaxa Etexilate is contraindicated in patients with mechanical prosthetic valves. The concomitant use of Pradaxa Etexilate with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. For patients with triple-positive antiphospholipid syndrome, treatment with Pradaxa Etexilate increases the risk of thrombosis.

Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, appropriate clinical support must be initiated, treatment with Pradaxa Etexilate should be discontinued, and the source of bleeding should be investigated. A specific reversal agent (idarucizumab) is available.

Anti-coagulants, Anti-platelet drugs, Fibrinolytics (Thrombolytics)

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