1. Wunderink RG, Cammarata SK, Oliphant TH, Kollef MH, for the Linezolid Nosocomial Pneumonia Study Group. Continuation of a randomized, double-blind, multicenter study of linezolid versus vancomycin in the treatment of patients with nosocomial pneumonia. Clin Ther. 2003;25(3):980-992.
   
   
2. Rubinstein E, Cammarata SK, Oliphant TH, Wunderink RG, and the Linezolid Nosocomial Pneumonia Study Group. Linezolid (PNU-100766) versus vancomycin in the treatment of hospitalized patients with nosocomial pneumonia: a randomized, double-blind, multicenter study. Clin Infect Dis. 2001;32(3):402-412.
   
   
3. Kollef MH, Rello J, Cammarata SK, Croos-Dabrera RV, Wunderink RG. Clinical cure and survival in Gram-positive ventilator-associated pneumonia: retrospective analysis of two double-blind studies comparing linezolid with vancomycin. Intensive Care Med. 2004;30(3):388-394.
   
   
4. Data on file. Pfizer Inc, New York, NY.
   
   
5. Lipsky BA, Itani K, Norden C, and the Linezolid Diabetic Foot Infections Study Group. Treating foot infections in diabetic patients: a randomized, multicenter, open-label trial of linezolid versus ampicillin-sulbactam/amoxicillin-clavulanate. Clin Infect Dis. 2004;38(1):17-24.
   
   
6. Conte JE Jr, Golden JA, Kipps J, Zurlinden E. Intrapulmonary pharmacokinetics of linezolid. Antimicrob Agents Chemother. 2002;46(5):1475-1480.
   
   
7. Boselli E, Breilh D, RimmelT, et al. Pharmacokinetics and intrapulmonary concentrations of linezolid administered to critically ill patients with ventilator-associated pneumonia. Crit Care Med. 2005;33(7):1529-1533.
   
   
8. Welshman IR, Sisson TA, Jungbluth GL, Stalker DJ, Hopkins NK. Linezolid absolute bioavailability and the effect of food on oral bioavailability. Biopharm Drug Dispos. 2001;22(3):91-97.
   
   
9. Wunderink RG, Rello J, Cammarata SK, Croos-Dabrera RV, Kollef MH. Linezolid vs vancomycin: analysis of two double-blind studies of patients with methicillin-resistant Staphylococcus aureus nosocomial pneumonia. Chest. 2003;124(5):1789-1797.
   
   
10. Farrell DJ, Mendes RE, Ross JE, Jones RN. Linezolid surveillance program results for 2008 (LEADER Program 2008). Diagn Microbiol Infect Dis. 2009;65(4):392-403.
    
    
11. Itani K, Dryden MS, Bhattacharyya H, Kunkel MJ, Baruch AM, Weigelt JA. Efficacy and safety of linezolid versus vancomycin for the treatment of complicated skin and soft-tissue infections proven to be caused by methicillin-resistant Staphylococcus aureus. Am J Surg. 2010;199(6):804-816.
    
    
12. Majcher-Peszynska J, Haase G, Saas M, et al. Pharmacokinetics and penetration of linezolid into inflamed soft tissue in diabetic foot infections. Eur J Clin Pharmacol. 2008;64(11):1093-1100.
    
    
13. Anderegg TR, Sader HS, Fritsche TR, Ross JE, Jones RN. Trends in linezolid susceptibility patterns: report from the 2002-2003 worldwide Zyvox Annual Appraisal of Potency and Spectrum (ZAAPS) Program. Int J Antimicrob Agents. 2005;26(1):13-21.
    
    
14. Draghi DC, Sheehan DJ, Hogan P, Sahm DF. In vitro activity of linezolid against key gram-positive organisms isolated in the United States: results of the LEADER 2004 surveillance program. Antimicrob Agents Chemother. 2005;49(12):5024-5032.
    
    
15. Draghi DC, Sheehan DF, Hogan P, Sahm DF. Current antimicrobial resistance profiles among methicillin-resistant Staphylococcus aureus encountered in the outpatient setting. Diagn Microbiol Infect Dis. 2006;55(2):129-133.
    
    
16. Jones RN, Kohno S, Ono Y, Ross JE, Yanagihara K. ZAAPS International Surveillance Program (2007) for linezolid resistance: results from 5591 Gram-positive clinical isolates in 23 countries. Diagn Microbiol Infect Dis. 2009;64(2):191-201.
    
    
17. Jones RN, Fritsche TR, Sader HS, Ross JE. LEADER surveillance program results for 2006: an activity and spectrum analysis of linezolid using clinical isolates from the United States (50 medical centers). Diagn Microbiol Infect Dis. 2007;59(3):309-317.
    
    
18. Jones RN, Ballow CH, Biedenbach DJ; ZAPS Study Group Medical Centers. Multi-laboratory assessment of the linezolid spectrum of activity using the Kirby-Bauer disk diffusion method: report of the Zyvox Antimicrobial Potency Study (ZAPS) in the United States. Diagn Microbiol Infect Dis. 2001;40(1-2):59-66.
    
    
19. Gerson SL, Kaplan SL, Bruss JB, et al. Hematologic effects of linezolid: summary of clinical experience. Antimicrob Agents Chemother. 2002;46(8):2723-2726.
    
    
20. Kumar S. Inflammation and infection: implication for chronic and end-stage kidney disease. Medscape. http://cme.medscape.com/viewarticle/465461-print. Published December 4, 2003. Accessed September 13, 2009.
    
    
21. American Thoracic Society/Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005;171(4):388-416.
    
    
22. American Diabetes Association. Kidney disease (nephropathy). American Diabetes Association. http://www.diabetes.org/living-with-diabetes/complications/kidney-disease-nephropathy.html. Accessed August 12, 2009.
    
    

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

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains) or Streptococcus pneumoniae.

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.

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

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

Community-acquired pneumonia caused by Streptococcus pneumoniae, 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.

ZYVOX use is contraindicated in patients with known hypersensitivity to linezolid or any of the other product components.

ZYVOX should not be used in patients taking any medicinal product which inhibits monoamine oxidases A or B (e.g. phenelzine, isocarboxazid) or within 2 weeks of taking any such product.

Unless patients are monitored for potential increases in blood pressure, ZYVOX should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis and/or patients taking any of the following: directly and indirectly acting sympathomimetic, vasopressive, and dopaminergic agents.

Unless patients are carefully observed for signs and/or symptoms of serotonin syndrome, ZYVOX should not be administered to patients with carcinoid syndrome and/or patients taking any of the following medications: serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists, meperidine, or buspirone.

Spontaneous reports of serotonin syndrome have been reported with the coadministration of ZYVOX and serotonergic agents. If signs or symptoms of serotonin syndrome, such as cognitive dysfunction, hyperpyrexia, hyperreflexia, and incoordination occur, discontinuation of one or both agents should be considered.

Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients receiving ZYVOX. In cases where the outcome is known, when ZYVOX was discontinued, the affected hematologic parameters returned to pretreatment levels. Complete blood counts should be monitored weekly, particularly in patients who receive ZYVOX for longer than 2 weeks.

ZYVOX is not approved and should not be used for the treatment of patients with catheter-related bloodstream infections or catheter-site infections.

ZYVOX has no clinical activity against Gram-negative pathogens and 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.

Clostridium difficile associated diarrhea has been reported with use of nearly all antibacterial agents, including ZYVOX, and may range in severity from mild diarrhea to fatal colitis.

Lactic acidosis has been reported with the use of ZYVOX. Patients receiving ZYVOX who develop recurrent nausea, vomiting, unexplained acidosis, or a low bicarbonate level should receive immediate medical evaluation.

Peripheral and optic neuropathy have been reported primarily in patients treated with ZYVOX for longer than the maximum recommended duration of 28 days. If patients experience symptoms of visual impairment, prompt ophthalmic evaluation is recommended.

Convulsions have been reported in patients treated with ZYVOX. In some of these cases, a history of seizures or risk factors for seizures was reported.

The most commonly reported adverse events in adults across phase 3 clinical trials were diarrhea, nausea, and headache.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

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