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Ceftaroline fosamil

Also known as: Zinforo · Teflaro

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In short

In the European Union, ceftaroline fosamil is indicated for the treatment of complicated skin and soft tissue infections and community-acquired pneumonia in neonates, infants, children, adolescents, and adults. In the United States, it is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of acute bacterial skin and skin structure infections, as well as community-acquired bacterial pneumonia in patients two months of age and older. To reduce the development of drug-resistant bacteria and maintain effectiveness, it should be used only to treat or prevent infections proven or strongly suspected to be caused by bacteria.

From: Source: European Medicines Agency (EMA), Zinforo — EPAR, 09/09/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1040004 ceftaroline fosamil
EMA
EMEA/H/C/002252

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) Ceftaroline Fosamil

1. INDICATIONS AND USAGE Ceftaroline fosamil for injection is a cephalosporin antibacterial indicated in adult and pediatric patients for the treatment of the following infection caused by designated susceptible bacteria: Acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) ( 1.1 ) Community-acquired bacterial pneumonia (CABP) in adult and pediatric patients 2 months of age and older ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 ) 1.1 Acute Bacterial Skin and Skin Structure Infections Ceftaroline fosamil for injection is indicated in adult and pediatric patients (at least 34 weeks gestational age and 12 days postnatal age) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes , Streptococcus agalactiae , Escherichia coli , Klebsiella pneumoniae, and Klebsiella oxytoca [see Dosage and Administration (2.2) and Use in Specific Populations ( 8.4 )]. 1.2 Community-Acquired Bacterial Pneumonia Ceftaroline fosamil for injection is indicated in adult and pediatric patients 2 months of age and older for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli. 1.3 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftaroline fosamil for injection and other antibacterial drugs, ceftaroline fosamil for injection should be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260529 · Official document →

EMA (EU) Zinforo

Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Source: European Medicines Agency (EMA), Zinforo — EPAR, 09/09/2025. © European Medicines Agency.

Document date: 09/09/2025 · Official document →

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Questions

What is Ceftaroline fosamil approved for in the European Union?

Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults: Complicated skin and soft tissue infections (cSSTI) Community-acquired pneumonia (CAP) Consideration should be given to official guidance on the appropriate use of antibacterial agents. (Source: European Medicines Agency (EMA), Zinforo — EPAR, 09/09/2025. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Zinforo — EPAR, 09/09/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →