ceftolozane sulfate + tazobactam sodium: clinical use

Prescribing considerations

• Reserve for bacterial infections within licensed indications and use microbiology results where available.
• Review renal function before and during treatment, particularly if impaired or changing.
• Consider the sodium contribution in patients requiring sodium restriction.
• Consider spectrum limitations: tazobactam does not inhibit all beta-lactamases, and activity is unreliable against some important Gram-positive organisms.
• Investigate diarrhoea during or after therapy for possible Clostridioides difficile infection.

Contraindications and cautions

• Hypersensitivity to ceftolozane, tazobactam or an excipient.
• Hypersensitivity to any cephalosporin antibacterial.
• Previous severe hypersensitivity, including anaphylaxis or a severe skin reaction, to another beta-lactam antibacterial such as a penicillin or carbapenem.

Monitoring

• Renal function and relevant changes during therapy.
• Clinical and microbiological response, including possible superinfection.
• Liver enzymes and blood counts when clinically indicated.
• Direct antiglobulin test results in context; seroconversion can occur without demonstrated haemolysis in trials.
• Symptoms of hypersensitivity or antibiotic-associated colitis.

Clinical pharmacology

Ceftolozane inhibits bacterial cell-wall synthesis. Tazobactam inhibits several class A beta-lactamases. Both are cleared mainly by the kidneys; ceftolozane is excreted largely unchanged, while tazobactam also forms an inactive metabolite.

Formulation and product differences

• Single-use powder for concentrate requiring reconstitution and further dilution before intravenous administration.
• The concentrate is not for direct injection.
• Each vial contains sodium; sodium chloride used for reconstitution increases the total sodium content.