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.
|
ZYVOX 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.
Published Studies Related to Zyvox (Linezolid)
Complicated skin and skin-structure infections and catheter-related bloodstream infections: noninferiority of linezolid in a phase 3 study. [2009.01.15]
BACKGROUND: Catheter-related bloodstream infection (CRBSI) causes substantial morbidity and mortality, but few randomized, controlled studies have been conducted to guide therapeutic interventions... CONCLUSIONS: Linezolid [generic for Zyvox] demonstrated microbiologic success rates noninferior to those for vancomycin in patients with cSSSIs and CRBSIs caused by gram-positive organisms. Patients with catheter-related infections must be carefully investigated for the heterogeneous underlying causes of high morbidity and mortality, particularly for infections with gram-negative organisms.
Early and extended early bactericidal activity of linezolid in pulmonary tuberculosis. [2008.12.01]
RATIONALE: Linezolid [generic for Zyvox], the first oxazolidinone approved for clinical use, has effective in vitro and promising in vivo activity against Mycobacterium tuberculosis. OBJECTIVES: To evaluate the early and extended early bactericidal activity of linezolid in patients with pulmonary tuberculosis... CONCLUSIONS: Linezolid has modest early bactericidal activity against rapidly dividing tubercle bacilli in patients with cavitary pulmonary tuberculosis during the first 2 days of administration, but little extended early bactericidal activity. Clinical trial registered with www.clinicaltrials.gov (NCT00396084).
Early microbiological response to linezolid vs vancomycin in ventilator-associated pneumonia due to methicillin-resistant Staphylococcus aureus. [2008.12]
BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is a common cause of ventilator-associated pneumonia (VAP). This prospective, open-label, multicenter clinical trial compared the early microbiological efficacy of linezolid [generic for Zyvox] (LZD) therapy with that of vancomycin (VAN) therapy in patients with MRSA VAP... CONCLUSION: Early microbiological cure rates were not statistically significantly higher with LZD therapy than with VAN therapy despite trends in all secondary clinical outcomes favoring LZD therapy. These results suggest that any beneficial effect of LZD therapy may be due to factors other than increased bacterial clearance. Trial registration: Clinicaltrials.gov Identifier: NCT00572559.
Efficacy and safety of tigecycline compared with vancomycin or linezolid for treatment of serious infections with methicillin-resistant Staphylococcus aureus or vancomycin-resistant enterococci: a Phase 3, multicentre, double-blind, randomized study. [2008.09]
INTRODUCTION: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) are causing serious nosocomial infections. Tigecycline was evaluated in hospitalized patients with MRSA or VRE infection... CONCLUSIONS: Tigecycline is safe and effective in hospitalized patients with serious infection caused by MRSA. There were too few cases of VRE to draw any conclusions.
Linezolid for the treatment of infections caused by Gram-positive pathogens in China. [2008.09]
In this randomised, double-blind, comparator-controlled, multicentre study conducted in China, 142 hospitalised patients aged 18-75 years with pneumonia (n=80) or complicated skin and soft-tissue infection (cSSTI) (n=62) due to suspected or known Gram-positive pathogens were randomised (1:1) to receive either linezolid [generic for Zyvox] 600mg (n=71) or vancomycin 1g in patients aged < or =60 years or 0.75g in patients aged >60 years (n=71) intravenously every 12h...
Clinical Trials Related to Zyvox (Linezolid)
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.
A Study To Assess The Effect Of Linezolid On QTc Interval [Recruiting]
The FDA has asked Pfizer to assess the risk of linezolid on QT interval (obtained from ECG
readings) which could predispose patients to ventricular arrhythmias. This study is
conducted to satisfy this requirement.
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB) [Not yet recruiting]
This is a one-period, double-blind, single-center pharmacokinetic study of linezolid in
patients with MDR or XDR tuberculosis treated with linezolid and an Optimized Background
Therapy (defined as treatment with > 4 drugs with activity against tuberculosis to which the
patient's isolate is believed to be sensitive by history or based on drug sensitivity
testing).
Study to Evaluate Eye Function in Patients Taking Linezolid for Two Months 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 two months or longer for the
development of signs or symptoms of visual disturbance or eye disorders
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.
|
ZYVOX PATIENT REVIEWS / RATINGS / COMMENTSBased 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). |
|
|
|
Page last updated: 2009-02-08
|
