Regulatory status and indications

Regulatory status and indications

Ceftazidime/avibactam (Zavicefta, Pfizer Limited) received a marketing authorisation in June 2016 and was launched in the UK in March 2017. Ceftazidime/avibactam is a combination antimicrobial that consists of a third generation cephalosporin, ceftazidime and a non‑beta‑lactam, beta‑lactamase inhibitor, avibactam.

Ceftazidime/avibactam is indicated for treating complicated intra-abdominal infections, complicated urinary tract infections, including pyelonephritis, hospital‑acquired pneumonia, including ventilator‑associated pneumonia, and infections due to aerobic gram‑negative organisms in adults with limited treatment options.

For full information see the summary of product characteristic (SPC): ceftazidime/avibactam.

Adults aged 18 years and over

Antimicrobial

Dosage and course length a in adults with estimated creatinine clearance of 51 ml/min or more

Ceftazidime/avibactam

2 g/0.5 g every 8 hours administered by intravenous infusion over 2 hours

  • Complicated intra‑abdominal infectionsb,c: duration 5 to 14 days

  • Complicated urinary tract infectionsc including pyelonephritis: duration 5 to 10 daysd

  • Hospital acquired pneumonia, including ventilator‑associated pneumoniac: duration 7 to 14 days

  • Infections due to aerobic gram‑negative organisms in adults with limited treatment optionsb,c: duration is guided by severity of the infection, the pathogen(s) and the person's clinical and bacteriological progresse

a Dose and course length taken from the SPC for ceftazidime/avibactam. Adults with an estimated creatinine clearance of 50 ml/min or less require the dose of ceftazidime/avibactam to be adjusted.

b Use in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process.

c Use in combination with an antibacterial agent active against gram-positive pathogens when these are known or suspected to be contributing to the infectious process.

d The total duration shown may include intravenous ceftazidime/avibactam followed by appropriate oral therapy.

e There is very limited experience with the use of ceftazidime/avibactam for more than 14 days.