Ceftaroline indications and usage

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Ceftaroline fosamil
TEFLARO® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Clinical Studies
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Teflaro® (ceftaroline fosamil) is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms.

1. Acute Bacterial Skin and Skin Structure Infections

Teflaro is indicated 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.

2. Community-Acquired Bacterial Pneumonia

Teflaro is indicated 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,andEscherichia coli.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat only ABSSSI or CABP 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.

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200327s001lbl.pdf