Linezolid KRKA – antibacterial agent for system use.

Treatment of the infections caused by sensitive strains of certain microorganisms at such states:

• nozokomialny pneumonia;
• not hospital pneumonia;
• complicated infections of skin and its structures, in particular infections against the background of diabetic foot without the accompanying osteomyelitis, are caused by Staphylococcus aureus (metitsillinchuvstvitelny and metitsillinrezistentny isolates), Streptococcus pyogenes or Streptococcus agalactiae. Linezolid was not studied in treatment of ulcer decubituses;
• uncomplicated infections of skin and its structures caused by Staphylococcus aureus (only metitsillinchuvstvitelny isolates) or Streptococcus pyogenes;
• infections, resistant to Vancomycinum, caused by Enterococcus faecium strains including the infections which are followed by bacteremia.

for treatment of the infections caused by gram-negative microorganisms. In case of suspicion or detection of the gram-negative activator it is necessary to start specific gram-negative therapy immediately.

Structure

• active ingredient: linezolid;
• 1 tablet, film coated, contains 600 mg of a linezolid;
• other components: microcrystalline cellulose, starch corn, krakhmalglikolit sodium (type A), hydroxypropyl cellulose, magnesium stearate;
• cover: gipromelloza, titan dioxide (E 171), macrogoal 6000, talc.

Contraindication

Hypersensitivity to a linezolid or any other component of drug.

Linezolid should not be applied to the patients taking any medications suppressing a monoaminooxidase And yes In (for example, fenelzin, an isocarboxazid, selegilin, moklobemid) and during 2 weeks after intake of such drugs.

except for cases when there is a possibility of careful observation and monitoring of the ABP in the following cases:

• uncontrollable arterial hypertension, pheochromocytoma, carcinoid syndrome, thyrotoxicosis, bipolar depression, schizoaffective disorder, sharp episodes of dizziness;
• accompanying intake of inhibitors of the return serotonin reuptake, tricyclic antidepressants, agonists 5-HT1 of receptors of serotonin (triptanes), direct and indirect sympathomimetics (including adrenergic bronchodilators, pseudoephedrine, a fenilpropayenofrin, fenilpropayenopin or a buspirona.

Should stop feeding by a breast during medicament use.

Side reactions

Most frequent side reactions about which reported were headaches, diarrhea, nausea and vomiting. About 3% of patients stopped treatment because of development of the side reactions caused by drug.

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to the Linezolid KRKA medicament treatment for oral administration. In that case selection of a dose is not required as the bioavailability of a linezolid at intake is nearly 100%.

Duration of treatment depends on the activator, localization and weight of an infection and also clinical effect. Tablets can be applied irrespective of food.

Maximum dose for adults and children should not exceed 600 mg 2 times a day.

Feature of use

Use during pregnancy or feeding by a breast

Use during pregnancy. There are no sufficient data on use of a linezolid to pregnant women. Results of researches on animals showed presence of reproductive toxicity. There is a potential risk for the person. Linezolid it is not necessary to apply during pregnancy, except cases when the expected advantage exceeds potential risk.

Use during feeding by a breast. Results of researches on animals showed that linezolid and its metabolites can get into breast milk. Therefore, it is necessary to stop feeding by a breast during medicament treatment.

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to children of 12 years.

Ability to influence speed of response at control of motor transport or other mechanisms

needs to warn patients about a possibility of development of dizziness or symptoms of a disorder of vision during reception of a linezolid and to recommend to them not to drive the car and not to work with mechanisms at emergence of the specified symptoms.

Specific antidote is unknown to

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did Not register overdose cases.

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At overdose showed symptomatic treatment with holding actions for maintenance of level of glomerular filtration. About 30% of the accepted dose of medicament are removed within 3 hours of a hemodialysis, but there are no data on removal of a linezolid during the procedures of peritoneal dialysis or hemoperfusion. Two primary metabolites of a linezolid are also removed by a hemodialysis.

Storage conditions

For medicine special storage conditions.

out of children's reach.