藥物警訊

Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors

AUDIENCE: Nursing, Pharmacy, Risk Manager

ISSUE: The U.S. Food and Drug Administration (FDA) is warning health care 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.

FDA evaluated seven reported cases of medication error that occurred during preparation of the dose in the pharmacy due to confusion with the display of the strength of individual ingredients on Zerbaxa's vial labels and carton labeling. Listing the individual drug strengths led to confusion because it was different from labeling for other drugs in the beta-lactam/beta-lactamase class that express strength as the sum of the two active ingredients. In some cases, this led to administration of 50% more drug than was prescribed. No adverse events were reported among these seven cases.

BACKGROUND: 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. Antibacterial drugs work by killing or stopping the growth of bacteria that can cause illness.

Read the MedWatch safety alert, including links to the Drug Safety Communication, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA發布藥物安全警訊，提醒醫療人員應注意抗微生物製劑ZerbaxaTM（cegtolozane + tazobactam）瓶身標示之藥品成分含量，以免造成用藥錯誤。

ZerbaxaTM可單獨用於治療複雜性泌尿道感染，或與其他抗微生物製劑metronidazole併用來治療複雜性腹腔感染。抗微生物製劑可使細菌死亡或抑制其生長。

FDA接獲7起因搞錯ZerbaxaTM藥品成分含量標示之用藥錯誤案例，主要原因為藥局調劑時不清楚ZerbaxaTM瓶身標示的含量為個別成份的含量。分別標示成分含量易造成混淆主要為其他抗微生物製劑（beta-lactam/beta-lactamase類）之藥品標示皆以兩種成分之總量表示。在部分案例中，此用藥錯誤導致給藥量超過開方劑量之50%以上，但未有副作用報告。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部