1 INDICATIONS AND USAGE
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)
1.1 Nosocomial Pneumonia
Linezolid Injection is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies (14)].
1.2 Community-acquired Pneumonia
Linezolid Injection is indicated for the treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [see Clinical Studies (14)].
1.3 Complicated Skin and Skin Structure Infections
Linezolid Injection is indicated for the treatment of complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae. Linezolid Injection has not been studied in the treatment of decubitus ulcers [see Clinical Studies (14)].
1.4 Uncomplicated Skin and Skin Structure Infections
Linezolid Injection is indicated for the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies (14)].
1.5 Vancomycin-resistant Enterococcus faecium Infections
Linezolid Injection is indicated for the treatment of vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies (14)].
1.6 Limitations of Use
Linezolid Injection is not indicated for the treatment of Gram-negative infections. It is critical that specific Gram-negative therapy be initiated immediately if a concomitant Gram-negative pathogen is documented or suspected [see Warnings and Precautions (5.4)].
The safety and efficacy of Linezolid Injection formulations given for longer than 28 days have not been evaluated in controlled clinical trials [see Clinical Studies (14)].
1.7 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Linezolid Injection 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 susceptible bacteria. 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.