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PiramalModel 66794-219-43 -Linezolid Injection

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These highlights do not include all the information needed to use LINEZOLID INJECTION safely and effectively. See full prescribing information for LINEZOLID INJECTION.

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Linezolid Injection is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1); Community-acquired pneumonia ( 1.2); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1.3); Uncomplicated skin and skin structure infections ( 1.4); Vancomycin-resistant Enterococcus faecium infections. ( 1.5)

Limitations of Use ( 1.6):

  • Linezolid Injection is not indicated for the treatment of Gram-negative infections.
  • The safety and efficacy of Linezolid Injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid Injection formulations and other antibacterial drugs, Linezolid Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.7)