ceftolozane / tazobactam
Zerbaxa · ATC code J01DI54
Also known as: Ceftolozan/Tazobactam, Seftolozan/Tazobaktam
- Key facts
- Active substance
- ceftolozane / tazobactam
- ATC code
- J01DI54
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Zerbaxa 1 g/0.5 g powder for concentrate for solution for infusion
- Marketing authorisation holder
- Merck Sharp & Dohme B.V.
- Information as of
- 2026-10-28
Key facts
Ceftolozane/tazobactam (Zerbaxa) combines a cephalosporin with a beta-lactamase inhibitor for intravenous infusion. It is used for complicated intra-abdominal and urinary tract infections and hospital-acquired pneumonia.
What it is used for
- Adults and paediatric patients: complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections.
- Adults (18 years or older): hospital-acquired pneumonia, including ventilator-associated pneumonia.
- Official guidance on the appropriate use of antibacterial agents should be considered.
Dosing
- Adults with creatinine clearance > 50 mL/min, intra-abdominal infection: 1 g ceftolozane / 0.5 g tazobactam every 8 hours as a 1-hour infusion for 4-14 days (with metronidazole when anaerobes are suspected).
- Adults, complicated urinary tract infection or pyelonephritis: 1 g / 0.5 g every 8 hours for 7 days.
- Adults, hospital-acquired pneumonia: 2 g ceftolozane / 1 g tazobactam every 8 hours for 8-14 days.
- Children with eGFR > 50 mL/min/1.73 m2: 20 mg/kg ceftolozane / 10 mg/kg tazobactam every 8 hours, up to 1 g / 0.5 g.
- Creatinine clearance ≤ 50 mL/min and haemodialysis require adjustment by table (e.g. 30 to 50 mL/min: 500 mg / 250 mg every 8 hours for urinary and intra-abdominal infections); see the full text.
Contraindications
- Hypersensitivity to the active substances, any of the excipients or any cephalosporin.
- Severe hypersensitivity (e.g. anaphylaxis, severe skin reaction) to any other beta-lactam antibacterial (e.g. penicillins, carbapenems).
Important warnings
- Serious and occasionally fatal hypersensitivity reactions are possible; discontinue if a severe allergic reaction occurs.
- A decline in renal function has been seen; adjust the dose to renal function.
- Clostridioides difficile-associated diarrhoea and pseudomembranous colitis have been reported.
- A positive direct antiglobulin (Coombs) test may develop.
- Contains 230 mg sodium per vial.
Side effects
- Most common in intra-abdominal and urinary infections: nausea, headache, constipation, diarrhoea and pyrexia, generally mild or moderate.
- Most common in hospital-acquired pneumonia: diarrhoea, ALT increased and AST increased.
Interactions
- No significant interactions via cytochrome P450 enzymes are anticipated.
- OAT1 or OAT3 inhibitors (e.g. probenecid) may increase tazobactam plasma concentrations.
Pregnancy and breastfeeding
- No data in pregnant women; use only if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ZerbaxaMerck Sharp & Dohme B.V. · EMEA/H/C/003772
Source: European Medicines Agency (EMA), product information
Turkey
- ZerbaxaMERCK SHARP DOHME İLAÇLARI LTD. ŞTİ. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Zerbaxa
- Liechtenstein
- Zerbaxa
- Norway
- Zerbaxa
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Zerbaxa – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zerbaxa-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.