The Food and Drug Administration (FDA) has approved Biorphen (phenylephrine HCl; Eton) injection for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. Biorphen is the first ready-to-use injectable formulation of phenylephrine approved for this use.

The approval of Biorphen was based on studies of phenylephrine, an α-1 adrenergic receptor agonist, in published literature. Following the development of hypotension during anesthesia, the administration of phenylephrine has been shown to raise systolic and mean blood pressure.

Biorphen is supplied as a 0.1mg/mL solution in 5mL single-dose ampules; this corresponds to 0.5mg of phenylephrine HCl per ampule, equivalent to 0.41mg of phenylephrine base. As the product is a ready-to-use formulation, it must not be diluted before administration. 

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Commenting on the approval, Heather Nixon, MD, Associate Professor Anesthesiology, University of Illinois at Chicago Hospital said, “The availability of Biorphen will help address many of the underlying causes for risk and error associated with compounded phenylephrine while also reducing potential for waste associated with overdrawing medications. This will be an important new tool for anesthesiologists, pharmacists and other hospital providers in their efforts to enhance patient safety and prevent patient harm.”

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