Abridged prescribing information ZERBAXA® (ceftolozane/tazobactam)

ZERBAXA^®: AI: ceftolozane 1 g/tazobactam 0.5 g. I (Adults): Indicated for the treatment of the following infections in which microorganisms recognised as susceptible are confirmed or suspected: Complicated intra-abdominal Infections (cIAI), in combination with metronidazole; Complicated urinary tract infections (cUTI), incl. pyelonephritis; Nosocomial pneumonia, incl. ventilator-associated pneumonia (VAP). D: i.v. infusion administered over 1 h, every 8 h. Creatinine clearance (CrCL) >50 ml/min: cIAI: 1,5 g (1 g ceftolozane/0,5 g tazobactam), 4-14 days; cUTI incl. pyelonephritis: 1,5 g (1 g ceftolozane/0,5 g tazobactam), 7 days; Nosocomial pneumonia, incl. VAP: 3 g (2 g ceftolozane/1 g tazobactam), 8-14 days. In patients suffering from moderate or severe renal impairment, as well as patients with end stage renal disease on haemodialysis, the dosage must be adjusted as indicated in the full prescribing information. For further indications and the corresponding dosages for adults and pediatric patients, please refer to the prescribing information. CI: Hypersensitivity to the active substances/excipients, antibiotics of the cephalosporin class. Severe hypersensitivity to other beta-lactam antibiotics. Pr: The occurrence of a serious allergic reaction, which may also be related to Kounis syndrome, requires discontinuation of the drug and implementation of appropriate measures.If severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme and acute generalized exanthematous pustulosis (AGEP) occur: use of ZERBAXA^® has to be discontinued immediately and an alternative therapy has to be considered. In patients with diarrhea during or subsequent to administration: consider antibiotic-associated colitis or pseudomembranous colitis. Use may lead to proliferation of non-susceptible microorganisms. In the case of a superinfection on treatment, start appropriate therapy. Very limited effect on certain Gram-positive organisms and anaerobes (additional antibacterial agents must be considered). Zerbaxa is considered rich in sodium. To be considered in patients on a low-sodium diet. DDI: OAT1 and OAT3 inhibitors may increase the plasma tazobactam concentrations. No interactions with substrates, inhibitors and inducers of CYP450 enzymes. P/L: Not recommended. UDE: cIAI/ cUTI, incl. pyelonephritis: common: nausea, headache, diarrhea, pyrexia, constipation, insomnia, vomiting, hypokalemia, ALT increased, AST increased, anemia, thrombocytosis, abdominal pain, anxiety, dizziness, hypotension, atrial fibrillation, rash, infusion site reactions. Nosocomial pneumonia, incl. VAP: common: diarrhea, vomiting, Clostridium difficile colitis, ALT increased, AST increased, transaminases increased, liver function test abnormal, blood alkaline phosphatase increased, gamma-glutamyltransferase increased, intracranial hemorrhage, renal impairment/renal failure. P: 10 vials containing 1.5 g. C: A. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, 6005 Lucerne, Switzerland. (V5.0); CH-ZER-00009.

Before prescribing, please consult the full prescribing information, published on the website of Swissmedic (www.swissmedicinfo.ch).