Drug Information Update- New Drug Safety Communication on Avycaz (ceftazidime & avibactam)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the intravenous antibacterial drug Avycaz (ceftazidime and avibactam) due to confusion about the drug strength displayed on the vial and carton labels. Avycaz was initially approved with the vial and carton labels displaying the individual strengths of the two active ingredients (i.e., 2 gram/0.5 gram); however, the product is dosed based on the sum of the active ingredients (i.e., 2.5 gram). To prevent medication errors, we have revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram (see Photos).

Avycaz is approved for intravenous administration to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen in patients with limited or no alternative treatment options. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness.

For more information, please visit: Avycaz.