Cefepime. Aifa: "Risk of serious adverse effects in patients with renal impairment with doses other than those recommended"



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"However, cases have been reported in patients with normal renal function and receiving doses higher than those recommended.In general, neurotoxicity symptoms disappeared after discontinuation of treatment and / or after treatment. hemodialysis, but some have had a fatal outcome. "This was announced in an urgent briefing note, Bristol-Myers Squibb, Polifarma and Bruno Farmaceutici, in agreement with AIFA.

November 26 – Inappropriate doses of cefepime may cause severe neurological adverse events in patients with renal impairment. This was announced in an urgent briefing note, Bristol-Myers Squibb, Polifarma and Bruno Farmaceutici, in agreement with the Italian Medicines Agency (AIFA).

"Most cases of neurotoxicity, it is said, have occurred in patients with renal impairment who have received higher doses than those recommended, particularly in elderly patients, but have been reported in patients normal renal function and that they received higher doses than those recommended.In general, the symptoms of neurotoxicity disappeared after discontinuation of treatment and / or after hemodialysis, but some cases had a fatal outcome ".

"In case of concomitant use of potentially nephrotoxic drugs such as aminoglycosides and potent diuretics, it is necessary to closely monitor renal function.In case of neurological disorders or worsening thereof, one can suspect an overdose of cefepime, the diagnosis being confirmed by plasma concentrations of cefepime ".

November 26, 2018
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