FDA approves ready-to-use 750-mg dosage of vancomycin

FDA has approved the premix formulation of vancomycin injection, USP (750 mg/150 mL) (Baxter). Vancomycin is an antibiotic used to treat severe infections caused by susceptible strains of methicillin-resistant Staphylococcus aureus and/or treat patients who are penicillin-resistant.

Previously offered in a concentrated vial format, this additional ready-to-use option in Baxter’s proprietary frozen GALAXY containers provides clinicians a frequently requested dosing option in a convenient premix formulation. This product will be available for clinician use early in 2011.

Baxter now offers 3 dosing options for premix vancomycin injection, USP, including 500 mg/100 mL, 750 mL/150 mL, and 1g/200 mL, in an effort to offer healthcare providers important therapies in formats that help minimize preparation time.

According to Scott Bojan, marketing manager for vancomycin, Baxter Healthcare, the 750-mg vancomycin dose represents a significant unmet need in the hospital setting for this antibiotic.

“With approval of the premix formulation, hospitals and managed care decision-makers now have a new option that is designed with more convenience in mind, with fewer steps required to prepare the product for administration,” Bojan told Formulary.

“Pharmacy and hospital workers are moving fast to deliver important products to their patients every day. The availability of a premix formulation in this frequently requested dosing size means fewer steps and possibly, fewer errors related to preparation and administration to patients. We believe this product will be a valuable addition to the portfolio of antibiotics available in the hospital setting,” Bojan said.

“Following many other premix products available on the market, this provides a common dosage product that offers convenience for use in all clinical settings,” said F. Randy Vogenberg, PhD, RPh, strategic pharmacy advisor, Business Group Pharmacy Collaborative, Greenbelt, Md., and Sharon, Mass., and senior fellow, Jefferson School of Population Health, Philadelphia. “In general, having premix products saves labor time while also ensuring properly prepared product in standard marked infusion bags that can assist in avoiding medication errors.”