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ceftaroline fosamil

Zinforo · ATC code J01DI02

Also known as: Ceftarolinfosamil, Seftarolin fosamil

Key facts
Active substance
ceftaroline fosamil
ATC code
J01DI02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Zinforo 600 mg powder for concentrate for solution for infusion
Marketing authorisation holder
Pfizer Ireland Pharmaceuticals
Information as of
2026-10-28

Key facts

Ceftaroline fosamil (Zinforo) is an intravenous cephalosporin antibiotic for complicated skin and soft tissue infections and community-acquired pneumonia, from neonates to adults.

What it is used for

  • Complicated skin and soft tissue infections (cSSTI).
  • Community-acquired pneumonia (CAP).
  • In neonates, infants, children, adolescents and adults; official guidance on antibacterial use should be considered.

Dosing

  • Adults (CrCL > 50 mL/min), standard dose: 600 mg every 12 hours as a 5–60 minute infusion.
  • High dose for cSSTI caused by S. aureus with an MIC of 2 mg/L or 4 mg/L: 600 mg every 8 hours over 120 minutes.
  • Children and adolescents: by age and weight, e.g. 12 mg/kg to a maximum of 400 mg every 8 hours (2 to < 12 years), 8 mg/kg (infants from 2 months), 6 mg/kg (neonates) – see the full text.
  • Treatment duration 5-14 days for cSSTI and 5-7 days for CAP.
  • Dose adjustment when CrCL ≤ 50 mL/min (see the full text); no adjustment for the elderly with CrCL > 50 mL/min.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Hypersensitivity to cephalosporins.
  • Immediate and severe hypersensitivity (e.g. anaphylaxis) to any other beta-lactam (e.g. penicillins, carbapenems).

Important warnings

  • Serious and occasionally fatal hypersensitivity reactions are possible.
  • Severe cutaneous adverse reactions (SJS, TEN, DRESS); withdraw immediately and never restart.
  • Clostridioides difficile-associated disease may occur.
  • Direct antiglobulin test (Coombs test) seroconversion, more frequent with the high dose.

Side effects

  • Most common (≥ 3% of patients): diarrhoea, headache, nausea and pruritus, generally mild or moderate.
  • Clostridium difficile colitis and severe hypersensitivity reactions may occur.
  • Greater incidence of rash in Asian patients with 600 mg every 8 hours.

Interactions

  • No clinical interaction studies; low interaction potential via CYP450 and renal transporters is expected.

Pregnancy and breastfeeding

  • As a precaution, preferably avoid in pregnancy unless the woman's condition requires an antibiotic with this antibacterial profile.

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.

Full official text →

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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)

  • ZinforoPfizer Ireland Pharmaceuticals · EMEA/H/C/002252

Source: European Medicines Agency (EMA), product information

Germany

  • Ceftarolinfosamil QiluDr. Friedrich Eberth Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Brand names in 5 more European countries
Iceland
Zinforo
Italy
Ceftarolina Fosamil Qilu
Liechtenstein
Zinforo
Norway
Zinforo
Spain
Ceftarolina Fosamilo Qilu

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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Sources

  1. European Medicines Agency. Zinforo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zinforo-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database

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.