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June 16, 2021Rezipres Approved to Treat Hypotension in Patients Under Anesthesia
June 15, 2021 – The U.S. FDA has approved Rezipres® (ephedrine hydrochloride injection), manufactured by Eton Pharmaceuticals, to treat clinically important hypotension occurring in the setting of anesthesia.
Hypotension, or low blood pressure, can occur under anesthesia due to factors such as blood loss or anesthesia side effects. It can put patients at risk regardless of whether they receive general anesthesia, in which a patient is unconscious during a procedure, or anesthesia that prevents pain without rendering a patient unconscious, such as an epidural used for C-sections.
In clinical studies, ephedrine produced increases in blood pressure in patients under general anesthesia or neuraxial anesthesia – when local anesthetics are used around the nerves of the central nervous system. Examples of neuraxial anesthesia include epidural, spinal, and caudal anesthesia.
Recommended dosing is an initial dose of 4.7mg to 9.4mg of Rezipres administered by intravenous (IV) bolus (a rapid IV injection) followed by additional boluses as needed. Dosage should be titrated according to the blood pressure goal. Total dosage should not exceed 47mg.
Launch and pricing information are not yet available.