Premix Cephalosporin Approved by FDA

The FDA has approved Baxter and Water Street’s cefazolin 2 g injection in a frozen premix, providing another cephalosporin antibacterial option for preoperative prophylaxis treatment.

“The availability of cefazolin 2 gram in an efficient, ready-to-use, flexible premix container that can improve pharmacy efficiency will provide additional supply options of an important antibiotic,” stated Brik Eyre, president of Baxter’s hospital products business.

Cefazolin has been on the FDA’s drug shortage list for more than a year because of high demand. To help fulfill this need, Baxter is aiming to launch the 2-gram injection in its 100-mL Galaxy container in the United States in the fourth quarter of this year.

When used for preoperative prevention, cefazolin may reduce the incidence of certain postoperative infections for high-risk patients undergoing surgical procedures. To reduce the development of drug-resistant bacteria, it should only be used to prevent infections that are strongly believed to be caused by bacteria.

An alternative cefazolin product should be used when lengthy surgical procedures require supplemental doses and when postoperative dosing is required.

The most common adverse reactions reported in patients who receive cefazolin are nausea, vomiting, diarrhea, and skin rash.