About Dabigatran Etexilate Mesylate API
Therapeutic CategoryCardiovascular
CAS Number
872728-81-9
API Technology
Synthetic
Dose Form
Oral Solid/Capsules
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF
Mechanism of Action
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.
Indication
PRADAXA 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
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FAQs
Prevents stroke and systemic embolism in patients with non-valvular atrial fibrillation
Treats deep vein thrombosis (DVT) and pulmonary embolism (PE)
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Available as oral capsules: 75 mg, 110 mg, 150 mg
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Store at 20°C to 25°C (68°F to 77°F), in the original container, protect from moisture
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