HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use LINEZOLID injection safely and effectively. See full prescribing information for LINEZOLID injection.
LINEZOLID injection, for intravenous use
Initial U.S. Approval: 2000
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Linezolid 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); Vancomycin-resistant Enterococcus faecium infections. (1.4)
Limitations of Use: (1.5)
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. (1.6)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Injection: 600 mg/300 mL (2 mg/mL) linezolid. (3)
WARNINGS AND PRECAUTIONS
Most common adverse reactions (>5% of adult and pediatric patients treated with linezolid) include: diarrhea, vomiting, headache, nausea, and anemia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
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