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About Dabigatran Etexilate Mesylate API

Product
  • 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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Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.