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Zyvox (Linezolid) - Summary

 
 



ZYVOX SUMMARY

ZYVOX®
(linezolid) injection
(linezolid) tablets
(linezolid) for oral suspension

ZYVOX I.V. Injection, ZYVOX Tablets, and ZYVOX for Oral Suspension contain linezolid, which is a synthetic antibacterial agent of the oxazolidinone class.

ZYVOX formulations are indicated in the treatment of the following infections caused by susceptible strains of the designated microorganisms (see PRECAUTIONS, Pediatric Use and DOSAGE AND ADMINISTRATION).

Vancomycin-Resistant Enterococcus faecium infections, including cases with concurrent bacteremia (see CLINICAL STUDIES).

Nosocomial pneumonia caused by Staphylococcus aureus (methicillin-susceptible and -resistant strains), or Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]). Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organisms (see CLINICAL STUDIES).

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. Combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organisms (see CLINICAL STUDIES).

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] *), 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.


*MDRSP refers to isolates resistant to two or more of the following antibiotics: penicillin, second-generation cephalosporins, macrolides, tetracycline, and trimethoprim/sulfamethoxazole.


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NEWS HIGHLIGHTS

Media Articles Related to Zyvox (Linezolid)

Zyvox® shows cost savings for treatment of skin infections
Source: The Doctors Lounge - Infections
Oral Zyvox® shows cost savings for outpatient treatment of skin and other infections when compared to vancomycin.

more news >>

Published Studies Related to Zyvox (Linezolid)

Linezolid in methicillin-resistant Staphylococcus aureus nosocomial pneumonia: a randomized, controlled study. [2012]
vancomycin regimen, for treatment of MRSA nosocomial pneumonia... CONCLUSIONS: For the treatment of MRSA nosocomial pneumonia, clinical response at

A randomised, double-blind trial comparing ceftobiprole medocaril with ceftriaxone with or without linezolid for the treatment of patients with community-acquired pneumonia requiring hospitalisation. [2012]
Community-acquired pneumonia (CAP) is a serious infection requiring hospitalisation in 20% of cases. The novel cephalosporin ceftobiprole has microbiological activity against the major bacterial pathogens causing CAP, including Streptococcus pneumoniae, Haemophilus influenzae and Klebsiella pneumoniae, as well as against Staphylococcus aureus, including meticillin-resistant S...

Comparison of serotonin toxicity with concomitant use of either linezolid or comparators and serotonergic agents: an analysis of Phase III and IV randomized clinical trial data. [2011.12.02]
Objectives and methodsThe present study's objective was to evaluate serotonin toxicity with concomitant use of linezolid or comparators and serotonergic agents from 20 Phase III and IV comparator-controlled clinical studies on treatment of various Gram-positive infections.Based on the large database of Phase III and IV studies included in our analysis, we did not find enough evidence to conclude that linezolid-induced serotonin toxicity was different from that of comparators.

Pharmacokinetics of intravenous and oral linezolid in adults with cystic fibrosis. [2011.07]
Linezolid is a treatment option for methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis (CF) patients. Little is known, however, about its pharmacokinetics in this population... and oral dosing regimens should be sufficient to reliably attain pharmacodynamic targets against most MRSA isolates; however, more frequent dosing may be required for isolates with MICs of >/= 2 mug/ml.

A randomized, double-blind phase 2 study comparing the efficacy and safety of an oral fusidic acid loading-dose regimen to oral linezolid for the treatment of acute bacterial skin and skin structure infections. [2011.06]
Fusidic acid (CEM-102), an orally bioavailable fusidane antibiotic with a unique mode of action, is under development for treatment of acute gram-positive bacterial skin and skin structure infections, including those caused by methicillin-susceptible and methicillin-resistant Staphylococcus aureus and streptococci.

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Clinical Trials Related to Zyvox (Linezolid)

Study to Evaluate Eye Function in Patients Taking Linezolid for Six Weeks or Greater [Recruiting]
To understand and characterize the effects of linezolid on the optic nerve by observing and following patients who have been treated with linezolid for six weeks or longer for the development of signs or symptoms of visual disturbance or eye disorders.

Drug Use Investigation of Linezolid (Regulatory Post Marketing Commitment Plan) [Enrolling by invitation]
Drug use investigation of Zyvox for patients with MRSA infection desease. The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Pharmacokinetics of Linezolid in Children With Cystic Fibrosis [Recruiting]
To determine the pharmacokinetic profile of IV (intravenous) and PO (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.

Cost Effectiveness Of Linezolid In Central America [Recruiting]
The therapy with Linezolid (LIN) represents better cost-effectiveness vs. Vancomycin (VAN) for the treatment of nosocomial Pneumonia associate to ventilator (VAP).

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection [Recruiting]
This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

more trials >>

Reports of Suspected Zyvox (Linezolid) Side Effects

Nausea (36)Drug Interaction (31)Vomiting (31)Platelet Count Decreased (29)Diarrhoea (27)Death (25)Renal Failure Acute (25)Hyponatraemia (25)Anaemia (24)Serotonin Syndrome (23)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Zyvox has an overall score of 9. The effectiveness score is 10 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
 

Zyvox review by 48 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   MRSA
Dosage & duration:   600 mg taken twice a day for the period of 10 days
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   It cured the MRSA. Major downside was high price. The resulting yeast infection was a bit irritating but not unexpected.I would highly recmmend zyvox to anyone with this particular strain of MRSA.
Side effects:   Yeast infection and minor queasiness.
Comments:   Pill form, 2 a day. It was pretty simple. I had been receiving it in the hospital as a drip (liquid).

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Page last updated: 2013-02-10

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