Abstract
Introduction: The treatment of chronic Pseudomonas aeruginosa infections is challenging, with resistance and antibiogram diversity accumulating during successive therapies. Some isolates are resistant to all licensed agents, creating treatment problems and an urgent need for new therapies. Among antibiotics in advanced development, ceftolozane/tazobactam has potent in vitro antipseudomonal activity, with low MICs even for strains with AmpC β‐lactamase‐, impermeability‐ and efflux‐mediated resistance to other β‐lactams. Case presentation: A bronchiectasis exacerbation in a 59‐year‐old man involved pan‐resistant P. aeruginosa. Meropenem/colistin therapy failed. Named‐patient ceftolozane/tazobactam 2+1 g every 8 h for 14 days restored baseline respiratory and inflammatory marker status, and the patient was discharged; the ceftolozane/tazobactam MIC was 8 µg ml−1, with most growth inhibited at 2 µg ml−1. Conclusion: A positive outcome in this difficult infection due to an otherwise pan‐resistant P. aeruginosa is notable, especially as the patient had failed prior therapy with other agents. We urge formal evaluation of ceftolozane/tazobactam in chronic pseudomonal lung infections.
Highlights
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria
ZERBAXA for Injection, 1.5 g (1 g/0.5 g) every 8 hours by intravenous infusion administered over 1 hour for patients 18 years or older with creatinine clearance (CrCl) greater than 50 mL/min. (2.1)
No dose adjustment is recommended for ZERBAXA in subjects with hepatic impairment
Summary
5.1 Decreased Efficacy in Patients with Baseline Creatinine Clearance of 30 to ≤ 50 mL/min. The recommended dosage regimen of ZERBAXA (ceftolozane/tazobactam) for Injection is 1.5 g (1 g/0.5 g) administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older and with normal renal function or mild renal impairment. In an embryo-fetal study in rats, tazobactam administered intravenously at doses up to 3000 mg/kg/day (approximately 19 times the recommended human dose based on body surface area comparison) produced maternal toxicity (decreased food consumption and body weight gain) but was not associated with fetal toxicity. The NOAEL for reduced F1 body weights was considered to be 40 mg/kg/day (approximately 0.3 times the recommended human dose based on body surface area comparison) It is not known whether ceftolozane or tazobactam is excreted in human milk. The product contains sodium chloride (487 mg/vial) as a stabilizing agent, citric acid (21 mg/vial), and L-arginine (approximately 600 mg/vial) as excipients
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