Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (a 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, as well as thrombin-induced platelet aggregation, are inhibited by the active moieties.

Dabiran® is a direct thrombin inhibitor indicated for:
Reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
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.
Reducing the risk of recurrence of DVT and PE in patients who have been previously treated.
The prophylaxis of DVT and PE in patients who have undergone hip replacement surgery.

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 on the first day, then 220 mg once daily. Temporarily discontinue Dabiran® before invasive or surgical procedures when possible, then restart promptly.

Dabigatran etexilate is contraindicated in patients with active pathological bleeding, a history of serious hypersensitivity reactions to Dabigatran etexilate, and those with mechanical prosthetic heart valves.

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

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

Pregnancy: Safety has not been established during pregnancy.
Lactation: Breastfeeding is not recommended during treatment with Dabigatran etexilate.
Pediatric Use: The 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 aged 65 and over, while 40% were 75 and over. The risk of stroke and bleeding increases with age, but the risk-benefit profile remains favorable in all age groups.

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 are receiving concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be beneficial 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.

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 a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
