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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].
Skin and Skin Structure Infections
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].
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes [see Clinical Studies].
Vancomycin-resistant Enterococcus faecium Infections
Vancomycin-resistant Enterococcus faecium infections, including cases with concurrent bacteremia [see Clinical Studies].
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 or prevent 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.
DOSAGE AND ADMINISTRATION
General Dosage and Administration
The recommended dosage for ZYVOX formulations for the treatment of infections is described in Table 1.
Table 1: Dosage Guidelines for ZYVOX
|Infection*||Dosage and Route of Administration||Recommended Duration of Treatment (consecutive days)|
|Pediatric Patients† (Birth through 11 Years of Age)||Adults and Adolescents (12 Years and Older)|
|Nosocomial pneumonia||10 mg/kg intravenously or oral‡ every 8 hours||600 mg intravenously or oral‡ 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 or oral‡ every 8 hours||600 mg intravenously or oral‡ every 12 hours||14 to 28|
|Uncomplicated skin and skin structure infections||< 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|
|* Due to the designated
pathogens [see INDICATIONS AND USAGE]
† Neonates < 7 days: Most pre-term neonates < 7 days of age (gestational age < 34 weeks) have lower systemic linezolid clearance values and larger AUC values than many full-term neonates and older infants. These neonates should be initiated with a dosing regimen of 10 mg/kg every 12 hours. Consideration may be given to the use of 10 mg/kg every 8 hours regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg every 8 hours by 7 days of life [see Use in Specific Populations and CLINICAL PHARMACOLOGY].
‡ Oral dosing using either ZYVOX Tablets or ZYVOX for Oral Suspension [see HOW SUPPLIED/Storage and Handling].
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. 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.
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.
Dosage Forms And Strengths
ZYVOX I.V. Injection: 100-mL (200 mg linezolid), 200-mL (400 mg linezolid) and 300-mL (600 mg linezolid) single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free.
ZYVOX 600 mg Tablet: white, capsule-shaped, film-coated tablet printed with “ZYVOX 600 mg”
ZYVOX for Oral Suspension: dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL.
Storage And Handling
ZYVOX I.V. Injection is available in single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap. The infusion bags and ports are latex-free. The infusion bags are available in the following package sizes:
100 mL bag (200 mg linezolid) NDC 0009-5137-01
200 mL bag (400 mg linezolid) NDC 0009-5139-01
300 mL bag (600 mg linezolid) NDC 0009-5140-01
ZYVOX Tablets are available as follows: 600 mg (white, capsule-shaped, film-coated tablets printed with “ZYVOX 600 mg”)
100 tablets in HDPE bottle NDC 0009-5135-01
20 tablets in HDPE bottle NDC 0009-5135-02
Unit dose packages of 30 tablets NDC 0009-5135-03
ZYVOX for Oral Suspension is available as a dry, white to off-white, orange-flavored granule/powder. When constituted as directed, each bottle will contain 150 mL of a suspension providing the equivalent of 100 mg of linezolid per each 5 mL. ZYVOX for Oral Suspension is supplied as follows:
100 mg/5 mL in 240-mL glass bottles NDC 0009-5136-01
Store at 25°C (77°F). Protect from light. Keep bottles tightly closed to protect from moisture. It is recommended that the infusion bags be kept in the overwrap until ready to use. Protect infusion bags from freezing.
Distributed by : Pharmacia & Upjohn Company Division of Pfizer Inc, NY, NY 10017. Revised: May 2013
Last reviewed on RxList: 5/31/2013
This monograph has been modified to include the generic and brand name in many instances.
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