Linezolid

Nosocomial pneumonia Community acquired pneumonia Zyvox is indicated in adults for the treatment of community acquired pneumonia and nosocomial pneumonia when known or suspected to be caused by susceptible Gram positive bacteria. 1 for the appropriate organisms).

Linezolid is not active against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected. 4) Zyvox is indicated in adults for the treatment of complicated skin and soft tissue infections only when microbiological testing has established that the infection is known to be caused by susceptible Gram positive bacteria.

Linezolid is not active against infections caused by Gram negative pathogens. 4). In these circumstances treatment against Gram negative organisms must be initiated concomitantly. Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist such as a microbiologist or infectious diseases specialist.

APO-LINEZOLID (linezolid) tablets are indicated for:

Treatment of adult patients with the following infections, when caused by susceptible strains of the designated aerobic Gram-positive micro-organisms: Note: APO-LINEZOLID 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 7 WARNINGS AND PRECAUTIONS).

Vancomycin-Resistant Enterococcus faecium (VREF) Infections:

APO-LINEZOLID is indicated for the treatment of the following infections when due to VREF: • Intra-abdominal, skin and skin-structure, and urinary tract infections (including cases associated with concurrent bacteremia) (see 14 CLINICAL TRIALS).

Note:

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. 6 ): • Linezolid is not indicated for the treatment of Gram-negative infections. • The safety and efficacy of linezolid 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 formulations and other antibacterial drugs, linezolid should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

1 Nosocomial Pneumonia Linezolid is indicated for the treatment of nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [see Clinical Studies ( 14 )]. 2 Community-acquired Pneumonia Linezolid 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 )].