Drug Class Description
Other Antibacterials
Generic Name
Linezolid
Drug Description
Zyvox 600 mg Film-Coated Tablets - Each tablet contains 600 mg linezolid - White, ovaloid tablet with “ZYVOX 600 mg” printed on one side.Zyvox 100 mg/5 ml Granules for Oral Suspension - Following reconstitution with 123 ml water, each 5 ml contains 100 mg linezolid - White to light-yellow, orange flavoured granules.Zyvox 2 mg/ml Solution for Infusion - 1 ml contains 2 mg linezolid. 300 ml infusion bags contain 600 mg linezolid - Isotonic, clear, colourless to yellow solution.
Presentation
Zyvox 600 mg Film-Coated Tablets, 100 mg/5 ml Granules for Oral Suspension, 2 mg/ml Solution for Infusion
Indications
ZYVOX formulatiZyvox is indicated for the treatment of the following infections when known or suspected to be caused by susceptible Gram positive bacteria. In determining whether Zyvox is an appropriate treatment, the results of microbiological tests or information on the preva lence of resistance to antibacterial agents among Gram positive bacteria should be taken into consideration.
• Nosocomial pneumonia
• Community acquired pneumonia
• Complicated skin and soft tissue infections (See Special Precautions) Linezolid should only be initiated in a hospital environment and after consultation with a relevant specialist. Combination therapy will be necessary if a concomitant Gram negative pathogen is documented or suspected. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Adult Dosage
Zyvox solution for infusion, film-coated tablets or oral suspension may be used as initial therapy. Patients who commence treatment on the parenteral formulation may be switched to either oral presentation when clinically indicated. In such circumstances, no dose adjustment is required as linezolid has an oral bioavailability of approximately 100%.
Recommended dosage and duration of treatment for adults: The duration of treatment is dependent on the pathogen, the site of infection and its severity, and on the patient's clinical response.
The following recommendations for duration of therapy reflect those used in the clinical trials. Shorter treatment regimens may be suitable for some types of infection but have not been eva luated in clinical trials.
The maximum treatment duration is 28 days. The safety and effectiveness of linezolid when administered for periods longer than 28 days have not been established.
No increase in the recommended dosage or duration of treatment is required for infections associated with concurrent bacteraemia.
The dose recommendation for the solution for infusion and the tablets/granules for oral suspension are identical and are as follows:
|
Infections |
Dosage |
Duration of treatment |
|
Nosocomial pneumonia |
600 mg twice daily |
10-14 Consecutive days |
|
Community acquired pneumonia |
600 mg twice daily |
10-14 Consecutive days |
|
Complicated skin and soft tissue infections |
600 mg twice daily |
10-14 Consecutive days |
Patients with renal insufficiency: No dose adjustment is required.
Patients with severe renal insufficiency (i.e. CLCR
