Dilution Zyvox ® -linezolid

Linezolid (Zyvox ®)

The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.

Usual Diluents

(Pre-made) Isotonic D5W

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[600 mg] [300 ml] [60 min]
[400 mg] [200 ml] [60 min]
(Infusion range: 30-120 min)

Stability / Miscellaneous

Usual dose: 600 mg q12 hours for 10 to 28 days.
Store at room temperature / Protect from light / Do not freeze.

Dosage adjustment not required in renal failure.
ZYVOX has been shown to be clinically active against key Gram-positive pathogens, including vancomycin-resistant strains of Enterococcus species (VRE).

INDICATIONS AND USAGE
ZYVOX formulations are indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms. Linezolid 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.

Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia.

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]).

Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. ZYVOX has not been studied in the treatment of decubitus ulcers.

Uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible only) or Streptococcus pyogenes.

Community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]1), including cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only).

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.

Dosage Guidelines for ZYVOX:

Infection	Dosage and Route of Administration		Recommended Duration of Treatment (consecutive days)
Infection	Pediatric Patients (Birth through 11 Years of Age)	Adults and Adolescents (12 Years and Older)	Recommended Duration of Treatment (consecutive days)
Complicated skin and skin structure infections	10 mg/kg IV or oral q8h	600 mg IV or oral q12h	10 to 14
Community-acquired pneumonia, including concurrent bacteremia	10 mg/kg IV or oral q8h	600 mg IV or oral q12h	10 to 14
Nosocomial pneumonia
Vancomycin-resistant Enterococcus faecium infections, including concurrent bacteremia	10 mg/kg IV or oral q8h	600 mg IV or oral q12h	14 to 28
Uncomplicated skin and skin structure infections	<5 yrs: 10 mg/kg oral q8h 5–11 yrs: 10 mg/kg oral q12h	Adults: 400 mg oral q12h Adolescents: 600 mg oral q12h	10 to 14
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 q12h. Consideration may be given to the use of 10 mg/kg q8h regimen in neonates with a sub-optimal clinical response. All neonatal patients should receive 10 mg/kg q8h by 7 days of life. Oral dosing: Use either ZYVOX Tablets or ZYVOX for Oral Suspension

Adult patients with infection due to MRSA should be treated with ZYVOX 600 mg q12h.

In limited clinical experience, 5 out of 6 (83%) pediatric patients with infections due to Gram-positive pathogens with MICs of 4 µg/mL treated with ZYVOX had clinical cures. However, pediatric patients exhibit wider variability in linezolid clearance and systemic exposure (AUC) compared with adults. In pediatric patients with a sub-optimal clinical response, particularly those with pathogens with MIC of 4 µg/mL, lower systemic exposure, site and severity of infection, and the underlying medical condition should be considered when assessing clinical response.

In controlled clinical trials, the protocol-defined duration of treatment for all infections ranged from 7 to 28 days. Total treatment duration was determined by the treating physician based on site and severity of the infection, and on the patient's clinical response.

No dose adjustment is necessary when switching from intravenous to oral administration. Patients whose therapy is started with ZYVOX I.V. Injection may be switched to either ZYVOX Tablets or Oral Suspension at the discretion of the physician, when clinically indicated.

Intravenous Administration
ZYVOX I.V. Injection is supplied in single-use, ready-to-use infusion bags (see HOW SUPPLIED for container sizes). 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.

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. In particular, 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.

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 (see Compatible Intravenous Solutions).

Compatible Intravenous Solutions
* 5% Dextrose Injection, USP
* 0.9% Sodium Chloride Injection, USP
* Lactated Ringer's Injection, USP

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.

HOW SUPPLIED

Injection
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

Pfizer
LAB-0139-17.0

May 2008

Source: [package insert]