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In four Phase III clinical trials, the adverse-event profile of ZAVICEFTA® was similar to that seen with either best available therapy, doripenem or meropenem 1-4
In vitro drug combination studies with ZAVICEFTA® have demonstrated neither synergy nor antagonism with the following drugs: metronidazole, tobramycin, levofloxacin, vancomycin, linezolid and colistin and tigecycline.
Interaction with other antimicrobial agents: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function. Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but due to the possibility of antagonism in vivo this drug combination should be avoided.
Interaction with other medicinal products and other forms of interaction: In vitro, probenecid, a potent OAT inhibitor, inhibits avibactam uptake by 56-70 %. potentially altering the elimination of avibactam. Since
a clinical interaction trial of avibactam and probenecid has not been conducted, co-administration is not recommended.
Avibactam showed no significant inhibition of cytochrome P450 enzymes in vitro. Avibactam and ceftazidime showed no in vitro cytochrome P450 induction at clinically relevant concentrations. Avibactam and ceftazidime do not inhibit the major renal or hepatic transporters in the clinically relevant exposure range, therefore the interaction potential via these mechanisms is considered low.
Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam and between ZAVICEFTA® and metronidazole.
Serious and occasionally fatal hypersensitivity reactions have been reported. In severe hypersensitivity reactions, treatment with ZAVICEFTA® must be discontinued immediately and adequate emergency measures must be initiated.
Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam medicine. Caution should be used if ZAVICEFTA® is given to patients with a history of non-severe hypersensitivity to other β-lactam medicines.
Clostridium difficile-associated diarrhoea (CDAD)
Antibacterial medicine-associated colitis and pseudo-membranous colitis have been reported with ZAVICEFTA® and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ZAVICEFTA®. Discontinuation of therapy with ZAVICEFTA® and the administration of specific treatment for Clostridium difficile should be considered. Medicines that inhibit peristalsis should not be given.
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