4.1 Therapeutic indications
Community acquired pneumonia
Linezolid 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. In determining whether Linezolid 2 mg/ml Solution for Infusion is an appropriate treatment, the results of microbiological tests or information on the prevalence of resistance to antibacterial agents among Gram-positive bacteria should be taken into consideration. (See section 5.1 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.
Complicated skin and soft tissue infections (see section 4.4).
Linezolid 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. Linezolid should only be used in patients with complicated skin and soft tissue infections with known or possible co-infection with Gram-negative organisms if there are no alternative treatment options available (see section 4.4). 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 an infectious diseases specialist.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).