ZYVOX- linezolid tablet, film coated
ZYVOX is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. ZYVOX 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) ].
Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant isolates) or Streptococcus pneumoniae [ see Clinical Studies (14) ].
Community-acquired pneumonia caused by Streptococcus pneumoniae , including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates only) [ see Clinical Studies (14) ].
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. ZYVOX has not been studied in the treatment of decubitus ulcers [ see Clinical Studies (14) ].
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [ see Clinical Studies (14) ].
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [ see Clinical Studies (14) ].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZYVOX and other antibacterial drugs, ZYVOX should be used only to treat 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.
The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.
The recommended dosage for ZYVOX formulations for the treatment of infections is described in Table 1.
|Dosage, Route and Frequency of Administration||Recommended Duration of Treatment (consecutive days)|
|Infection *||Pediatric Patients † (Birth through 11 Years of Age)||Adults and Adolescents (12 Years and Older)|
|Community-acquired pneumonia, including concurrent bacteremia||10 mg/kg intravenously or oral ‡ every 8 hours||600 mg intravenously or oral ‡ every 12 hours||10 to 14|
|Complicated skin and skin structure infections|
|Vancomycin-resistant Enterococcus faecium infections , including concurrent bacteremia||10 mg/kg intravenously or oral ‡ every 8 hours||600 mg intravenously or oral ‡ every 12 hours||14 to 28|
|Uncomplicated skin and skin structure infections||less than 5 yrs: 10 mg/kg oral ‡ every 8 hours 5–11 yrs: 10 mg/kg oral ‡ every 12 hours||Adults: 400 mg oral ‡ every 12 hours Adolescents: 600 mg oral ‡ every 12 hours||10 to 14|
No dose adjustment is necessary when switching from intravenous to oral administration.
ZYVOX I.V. Injection is supplied in single-use, ready-to-use infusion bags. Parenteral drug products should be inspected visually for particulate matter prior to administration. Check for minute leaks by firmly squeezing the bag. If leaks are detected, discard the solution, as sterility may be impaired . Keep the infusion bags in the overwrap until ready to use. Each overwrap contains a peel-off label. Apply the peel-off label to the infusion bag for barcode scanning before use. Store at room temperature. Protect from freezing. ZYVOX I.V. Injection may exhibit a yellow color that can intensify over time without adversely affecting potency.
ZYVOX I.V. Injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous infusion bag in series connections. Additives should not be introduced into this solution. If ZYVOX I.V. Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each product.
If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of ZYVOX I.V. Injection with an infusion solution compatible with ZYVOX I.V. Injection and with any other drug(s) administered via this common line.
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