2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
The recommended dosage for linezolid injection for the treatment of infections is described in Table 1. No dose adjustment is necessary when switching from intravenous to oral administration.
|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)|
|Nosocomial pneumonia||10 mg/kg intravenously every 8 hours||600 mg intravenously every 12 hours||10 to 14|
|Community-acquired pneumonia, including concurrent bacteremia|
|Complicated skin and skin structure infections|
|Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia||10 mg/kg intravenously every 8 hours||600 mg intravenously every 12 hours||14 to 28|
The maximum dose for pediatric patients should not exceed the recommended adult dose. The recommended dose is 10 mg per kg intravenously every 8 hours. Linezolid injection in a single use VisIV™ Container should be used only in pediatric patients who require the entire 600 mg dose and not any fraction thereof.
2.2 Intravenous Administration
Linezolid injection is supplied in single-dose, ready-to-use container (VisIV™ Container) [see How Supplied/Storage and Handling (16)]. 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 containers in the overwrap until ready to use. Store at room temperature. Protect from freezing. Linezolid injection may exhibit a yellow color that can intensify over time without adversely affecting potency.
Linezolid injection should be administered by intravenous infusion over a period of 30 to 120 minutes. Do not use this intravenous container in series connections. Additives should not be introduced into this solution. If Linezolid 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. Discard unused portion.
If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Linezolid injection with an infusion solution compatible with Linezolid injection and with any other drug(s) administered via this common line.
Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer's Injection, USP.
Physical incompatibilities resulted when Linezolid injection was combined with the following drugs during simulated Y-site administration: amphotericin B, chlorpromazine HCl, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when Linezolid injection was combined with ceftriaxone sodium.