Zyvox mg film-coated tablets 2. Qualitative and quantitative zyvox zyvox emc Each tablet contains mg linezolid. For the full list of excipients, see section 6. Pharmaceutical form Film-coated tablet. In determining whether Zyvox is see more appropriate treatment, zyvox emc results zyvox emc microbiological tests or information on the prevalence of resistance zyvox emc antibacterial agents among Gram zyvox emc bacteria should be taken into consideration see section 5.
Linezolid is not zyvox emc against infections caused by Gram negative pathogens. Specific therapy against Gram negative organisms must be initiated concomitantly if a Gram negative pathogen is documented or suspected.
Complicated skin and soft tissue infections see section 4.
Linezolid should only be used in patients with complicated skin and soft tissue infections with known or possible co-infection with Gram negative organisms if there are no alternative treatment options zyvox emc see section 4.
Zyvox emc these circumstances treatment zyvox emc Gram negative organisms must be initiated concomitantly. Linezolid should only be initiated in a zyvox emc environment and after consultation with a relevant specialist such as a microbiologist or infectious diseases specialist. Consideration should be given to zyvox emc guidance on the appropriate use of zyvox emc agents.
Zyvox solution for infusion, film-coated tablets or oral suspension zyvox emc be zyvox emc zyvox emc initial therapy. Patients who commence treatment on the zyvox emc formulation may be switched to either oral presentation when clinically indicated. Recommended dosage and duration of treatment for adults: The duration of treatment is dependent on the pathogen, the site of infection and its severity, zyvox emc on the patient's clinical response.
The following zyvox emc for duration of therapy reflect those used zyvox emc the clinical zyvox emc. Shorter zyvox emc regimens may be suitable for some types of infection but have not zyvox emc evaluated in clinical trials.
The maximum treatment duration is 28 days. The safety and zyvox emc of linezolid when administered for periods longer than 28 days have not been established. No increase in the recommended zyvox emc or duration of treatment is required for infections associated with concurrent bacteraemia. Zyvox emc available data are described in section 4. No dose adjustment is required.
No dose adjustment is required see sections 4. Severe renal impairment i.
Due to the unknown clinical zyvox emc of higher zyvox emc up to 10 fold to the two primary metabolites of linezolid in patients with severe renal insufficiency, linezolid should be used with special caution zyvox emc these patients and only when the anticipated zyvox emc is considered to outweigh the theoretical risk.
The primary metabolites of linezolid are removed to some extent by haemodialysis, but zyvox emc concentrations of these metabolites are still very considerably higher following dialysis zyvox emc those observed in patients with normal renal zyvox emc or mild to moderate renal zyvox emc. Therefore, linezolid should be zyvox emc with special zyvox emc in patients with severe renal insufficiency who are undergoing dialysis and only when the anticipated benefit is considered to outweigh the theoretical risk.
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To date, there zyvox emc no experience of linezolid administration zyvox emc patients undergoing continuous ambulatory peritoneal dialysis CAPD or alternative treatments for renal failure other than haemodialysis.
However, there are limited clinical data and it is recommended that linezolid should be used in such patients only when the anticipated benefit is considered to outweigh the theoretical continue reading see sections 4. The recommended linezolid dosage should be administered orally twice zyvox emc.
The film-coated tablets may be taken with or without zyvox emc. Linezolid should not zyvox emc used in patients taking any medicinal product which inhibits monoamine oxidases A zyvox emc B e. Unless there are facilities available zyvox emc close zyvox emc and monitoring of blood pressure, linezolid should not be administered to patients with the following underlying clinical conditions or on the following types of concomitant medications: Animal data suggest that linezolid visit web page its metabolites may zyvox emc into breast milk and, accordingly, breast-feeding should be discontinued prior to and throughout administration see section 4.
Myelosuppression including anaemia, leucopenia, pancytopenia and thrombocytopenia has been reported in patients receiving linezolid. In cases where the outcome is known, when linezolid was discontinued, the affected haematologic parameters have risen toward pretreatment levels. The risk zyvox emc these effects appears to be related here the duration of treatment.
Zyvox emc patients treated with linezolid may be at greater risk of experiencing blood dyscrasias than zyvox emc patients. Zyvox emc may occur more commonly in patients with read more renal zyvox emc, whether or not on dialysis. Zyvox emc, close monitoring of blood counts is recommended zyvox emc patients zyvox emc Linezolid should be administered to such patients only when close monitoring of haemoglobin levels, blood counts and platelet counts is possible.
If zyvox emc myelosuppression zyvox emc during zyvox emc therapy, treatment should be stopped unless it is considered absolutely necessary to continue therapy, in which case intensive monitoring of blood zyvox emc and appropriate management strategies should be implemented.
In addition, it is recommended that complete blood counts including haemoglobin levels, platelets, and total and differentiated leucocyte counts should zyvox emc monitored weekly in patients who receive linezolid regardless of baseline blood count. Zyvox emc compassionate use studies, a zyvox emc incidence of serious anaemia was reported in patients receiving linezolid for more than the maximum recommended duration of 28 days.
These patients more often required blood transfusion.
Cases of anaemia requiring blood zyvox emc have also been reported post marketing, with more cases occurring in zyvox emc zyvox emc received linezolid therapy for more than 28 days.
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