Dabixta 75 mg

INDICATIONS

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 venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days. ... Read moreDabigatran 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 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.

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

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.

INTERACTION

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.

SIDE EFFECTS

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, or burning, stomach pain. In some people Dabigatran Etexilate can cause symptoms of an allergic reaction.

PREGNANCY & LACTATION

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

PRECAUTIONS & WARNINGS

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 valves. The concomitant use of Dabigatran 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 Dabigatran Etexilate increases the risk of thrombosis.

THERAPEUTIC CLASS

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

STORAGE CONDITIONS

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