2 DOSAGE AND ADMINISTRATION
2.1 General Dosage and Administration
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
|Adults: 400 mg oral‡ every
Adolescents: 600 mg oral‡ every 12 hours
|10 to 14|
No dose adjustment is necessary when switching from intravenous to oral administration.
2.2 Intravenous 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.
Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, and Lactated Ringer's Injection, USP.
Physical incompatibilities resulted when ZYVOX I.V. 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 ZYVOX I.V. Injection was combined with ceftriaxone sodium.
2.5 Constitution of Oral Suspension
ZYVOX for Oral Suspension is supplied as a powder/granule for constitution. Gently tap bottle to loosen powder. Add a total of 123 mL distilled water in two portions. After adding the first half, shake vigorously to wet all of the powder. Then add the second half of the water and shake vigorously to obtain a uniform suspension. After constitution, each 5 mL of the suspension contains 100 mg of linezolid. Before using, gently mix by inverting the bottle 3 to 5 times. Do not shake. Store constituted suspension at room temperature. Use within 21 days after constitution.