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About Treprostinil API

Product
  • Therapeutic CategoryCardiovascular

  • CAS Number

    81846-19-7

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Tablets, Injectable, Solution

  • Dr Reddy's Development Status

    Available

  • Available Regulatory Filing

    USDMF, EUDMF, Canada DMF, Israel DMF

Mechanism of Action

The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

Indication

Remodulin is a prostacyclin vasodilator indicated for:

  • Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).
  • Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

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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.