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FDA Cautions Against Dosing Errors for Antibacterial Drug Zerbaxa


Last week, the U.S. Food and Drug Administration published a Drug Safety Communication warning healthcare professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.

Zerbaxa's vial label was initially approved with a strength that reflects each individual active ingredient. However, the product is dosed based on the sum of these ingredients, which caused confusion and errors. In some cases, this led to administration of 50% more drug than was prescribed.

To prevent future medication errors, the strength on the drug labeling has been revised to reflect the sum of the two active ingredients. Thus, one vial of Zerbaxa will now list the strength as 1.5 grams equivalent to ceftolozane 1 gram and tazobactam 0.5 gram

Zerbaxa is used to treat complicated infections in the urinary tract, or in combination with the antibacterial drug metronidazole to treat complicated infections in the abdomen.

If you or a loved one has experienced complications resulting from defective drugs, please visit our Defective Drug & Medical Device page to learn more about such claims or click here to contact us for a free legal consultation.

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