Ready-to-Use Ephedrine Injection Gets FDA Approval

The Food and Drug Administration has approved the New Drug Application (NDA) for Emerphed (Nexus Pharmaceuticals), a premixed, ready-to-use formulation of ephedrine sulfate. 

Emerphed, a sympathomimetic amine, is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. It will be available as 50mg of ephedrine sulfate per 10mL; this is equivalent to 38mg of ephedrine base per 10mL vial. As the product is a ready-to-use formulation, it must not be diluted before administration.

Ephedrine sulfate works by directly acting as an alpha- and beta-adrenergic agonist and indirectly causing the release of norepinephrine. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Ephedrine sulfate stimulates heart rate and cardiac output and variably increases peripheral resistance, resulting in increased blood pressure.  

“With the approval of our Emerphed Injection, Nexus Pharmaceuticals is looking to streamline the standard of care in the operating room,” said Mariam S. Darsot, CEO of Nexus Pharmaceuticals.

For more information visit nexuspharma.net.