1 INDICATIONS AND USAGE
Linezolid for oral suspension 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 for oral suspension is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of Linezolid for oral suspension 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 for oral suspension formulations and other antibacterial drugs, linezolid should be used only treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
1.7)
1.1 Nosocomial Pneumonia
Linezolid for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension has not been studied in the treatment of decubitus ulcers [
see
Clinical Studies (14)
].
1.4 Uncomplicated Skin and Skin Structure Infections
Linezolid for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension 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 for oral suspension and other antibacterial drugs, linezolid for oral suspension 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.