FDA Warns of Possible Dosing Error for Combo Antibiotic
The Food and Drug Administration (FDA) is warning healthcare professionals about possible dosing errors with Avycaz (ceftazidime and avibactam; Actavis) injection due to confusion about the drug strength shown on the vial and carton labels.
Avycaz was approved in February 2015 with the individual strengths of the active ingredients (eg, 2g/0.5g) on the vial and carton labels. However, the drug's dose is based on the sum of the active ingredients (eg, 2.5g). Since its approval, the FDA has received three medication error reports related to confusion over the strengths displayed on the Avycaz vial and carton labels. Two cases occurred during preparation of the dose in the pharmacy. The patients were prescribed 1.25g, the recommended dose for their level of renal impairment. The pharmacies prepared the Avycaz dose based on the ceftazidime portion alone rather than the intended 1g of ceftazidime and 250mg of avibactam. No adverse events were reported, but based on the information provided in the postmarketing reports, the FDA is aware that at least one of the two patients received a higher-than-intended dose. The third case described a concern that the strength displayed for Avycaz differed from how drug strengths are displayed for other beta-lactam/beta-lactamase drugs such as Zosyn and Unasyn.
Avycaz is a cephalosporin and beta-lactamase inhibitor combination antibiotic indicated to treat susceptible infections including complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including pyelonephritis.
Following these reports, the manufacturer has revised the labels to display that each vial contains Avycaz 2.5g, equivalent to ceftazidime 2g and avibactam 0.5g.
For more information call (855) 543-3784 or visit FDA.gov.