Linebiotic is an antibacterial agent for systemic use.
Treatment of infections caused by susceptible strains of specified microorganisms in the following conditions:
nosocomial pneumonia; community-acquired pneumonia; complicated skin and skin structure infections, including diabetic foot infections without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, or Streptococcus agalactiae (linezolid has not been studied in the treatment of pressure ulcers); uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes; vancomycin-resistant infections caused by strains of Enterococcus faecium, including infections accompanied by bacteremia.
Warehouse
1 ml of solution contains 2 mg of linezolid; excipients: sodium citrate, citric acid anhydrous, glucose monohydrate, sodium chloride, sodium hydroxide, water for injections.
Contraindication
Known hypersensitivity to linezolid or any of the excipients. Linebiotic should not be used in patients taking any monoamine oxidase A or B inhibitor (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) or within two weeks of taking such medicinal products. Unless close observation and monitoring of blood pressure are possible, Linebiotic should not be used in patients with the following concomitant clinical conditions or concomitantly with the following medicinal products:
uncontrolled arterial hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute episodes of dizziness;
Method of application
The duration of treatment depends on the pathogen, location and severity of the infection, as well as the clinical effect.
The duration of therapy recommendations below have been used in clinical trials. For some types of infections, shorter durations of treatment may be appropriate, but have not been evaluated in clinical trials.
The maximum duration of treatment is 28 days.
The safety and efficacy of linezolid for use beyond 28 days have not been studied. No increase in recommended doses or duration of treatment is necessary for infections accompanied by bacteremia.
Patients initiated on intravenous linezolid may be switched to oral linezolid. In this case, dose adjustment is not necessary since the oral bioavailability of linezolid is nearly 100%.
Application features
If significant myelosuppression develops during treatment with linezolid, treatment should be discontinued unless continued treatment is considered essential. In such situations, close monitoring of complete blood counts and appropriate treatment strategies should be implemented.
Pregnant women
Linebiotic should not be used during pregnancy unless the expected benefit outweighs the potential risk.
Children
Used from the first days of life.
Drivers
Patients should be warned about the possibility of developing dizziness or visual symptoms while taking linezolid and advised not to drive or operate machinery if these symptoms occur.
Overdose
No cases of overdose have been reported.
Side effects
Infections and infestations: candidiasis, oral candidiasis, vaginal candidiasis, fungal infections, vaginitis, antibiotic-associated colitis including pseudomembranous colitis.
From the blood and lymphatic system: anemia, leukopenia, neutropenia, thrombocytopenia, eosinophilia, pancytopenia, myelosuppression, sideroblastic anemia.
Immune system disorders: anaphylaxis.
Storage conditions
Store in original packaging at a temperature not exceeding 25°C. Keep out of the reach of children.
