Avycaz (ceftazidime and avibactam): Drug Safety Communication – Dose Confusion and Medication Errors
AUDIENCE: Infectious Disease, Pharmacy
ISSUE: FDA is augury health care professionals about the dare to undertake for dosing errors with the intravenous antibacterial medicine Avycaz (ceftazidime and avibactam) due to agitation about the drug strength displayed attached the vial and carton labels. Avycaz was initially approved by the vial and carton labels displaying the individual strengths of the brace active ingredients (i.e., 2 gram/0.5 gram); but, the product is dosed based without ceasing the sum of the active ingredients (i.e., 2.5 gram). To intercept medication errors, FDA revised the labels to designate that each vial contains Avycaz 2.5 gram, synonymous to ceftazidime 2 gram and avibactam 0.5 gram.
Since Avycaz’s approval in February 2015, FDA received reports of three medication error cases allied to confusion on how the excellence was displayed on the Avycaz phial and carton labels. Two cases settled that the errors occurred during qualification fitting of the dose in the pharmacy. The third part case described concern about the in posse for confusion because the strength displayed in spite of Avycaz differs from how the lustiness is displayed for other beta-lactam/beta-lactamase drugs. Based ~ward the information provided in the reports, FDA is observant that at least one of the patients believed a higher-than-intended dose of Avycaz. No calamitous events were reported.
BACKGROUND: Avycaz is approved by reason of intravenous administration to treat complicated infections in the urinary sermon, or in combination with the antibacterial physic metronidazole to treat complicated infections in the paunch in patients with limited or no alternative treatment options.
RECOMMENDATION: Due to reports of medication errata associated with Avycaz, the vial and carton labels bear been revised to indicate that each vial contains Avycaz 2.5 gram, interchangeable to ceftazidime 2 gram and avibactam 0.5 gram.
Healthcare professionals and patients are encouraged to take down adverse events or side effects cognate to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the give an account of Online: www.fda.gov/MedWatch/make minutes of
Download form or call 1-800-332-1088 to ask for a reporting form, then complete and go to the address on the pre-addressed con~ation, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
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