Drug Information for EPOPROSTENOL (GeneraMedix Inc ): DESCRIPTION

Epoprostenol for Injection is a sterile sodium salt formulated for intravenous (IV) administration. Each vial of Epoprostenol for Injection contains epoprostenol sodium equivalent to 1.5 mg (1,500,000 ng) epoprostenol, 50 mg arginine, and 50 mg mannitol. Sodium hydroxide is added to adjust pH.

Epoprostenol (PGI2, PGX, prostacyclin), a metabolite of arachidonic acid, is a naturally occurring prostaglandin with potent vasodilatory activity and inhibitory activity of platelet aggregation.

Epoprostenol is (5 Z,9a,11a,13E,15S)-6,9-epoxy-11,15-dihydroxyprosta-5,13-dien-1-oic acid. Epoprostenol sodium has a molecular weight of 374.45 and a molecular formula of C₂₀H₃₁NaO₅. The structural formula is:

Epoprostenol for Injection is a white to off-white lyophilized material that may be translucent. It is reconstituted with Sterile Water for Injection, USP, or Sodium Chloride 0.9% Injection, USP.

The reconstituted solution of Epoprostenol for Injection has a pH of >11.0 and is increasingly unstable at a lower pH.