Linezolid solution for infusion is indicated for the treatment of infections caused by susceptible strains of anaerobic or aerobic gram-positive microorganisms, including infections accompanied by bacteremia, such as:
nosocomial pneumonia; community-acquired pneumonia; complicated skin and skin structure infections, especially diabetic foot infections without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin and methicillin-resistant isolates), Streptococcus pyogenes or Streptococcus agalactiae; uncomplicated skin and skin structure infections caused by Staphylococcus aureus (methicillin isolates only) or Streptococcus pyogenes; infections caused by enterococci, including vancomycin-resistant strains of Enterococcus faecium and faecalis.
If the causative agents of the infection include gram-negative microorganisms, the appointment of combination therapy is clinically indicated.
Composition
active ingredient: linezolid;
1 ml 2 mg linezolid; 300 ml of solution for infusion in the system contains 600 mg linezolid;
Excipients: sodium citrate dihydrate, citric acid, glucose monohydrate, hydrochloric acid *, sodium hydroxide *, water for injections.
* Used in the production process to set the pH of the solution within 4.6-5.2.
Contraindication
Known hypersensitivity to linezolid or any of the excipients. Linezolid should not be administered to patients taking any monoamine oxidase A or B inhibitor (e.g. phenelzine, isocarboxazid, selegiline, moclobemide) or within two weeks of taking such agents.
Unless close observation and monitoring of blood pressure are possible, Linezolid should not be administered to patients with the following concomitant clinical conditions or concomitant use of the following drugs:
uncontrolled arterial hypertension, pheochromocytoma, carcinoid, thyrotoxicosis, bipolar depression, schizoaffective disorder, acute episodes of dizziness; serotonin reuptake inhibitors, tricyclic antidepressants, 5-HT 1 serotonin receptor agonists (triptans), direct and indirect sympathomimetics (including adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine), vasopressors (epinephrine, norepinephrine), dopaminergic compounds (dopamine, dobutamine), pethidine or buspirone.
Method of administration and doses
Patients who have been initiated on Linezolid solution for intravenous infusion may be switched to oral linezolid. In this case, dose adjustment is not necessary because oral bioavailability of linezolid is nearly 100%.
The infusion is carried out over 30-120 minutes.
When Linezolid for intravenous injection is administered concomitantly with other drugs, each drug should be administered separately, according to the recommended dose and route of administration for each drug.
When using the same intravenous system for sequential administration of several drugs, this system should be flushed with an infusion solution compatible with linezolid and with the other drug being administered through this system before and after administration of Linezolid for intravenous infusion.
Compatible infusion solutions: 0.9% sodium chloride solution for injection, 5% glucose solution for injection, lactated Ringer's solution for injection.
Application features
Pregnant women
Linezolid should not be taken during pregnancy unless the expected benefit outweighs the potential risk.
Children
Apply from the first days of life.
Drivers
Patients should be warned about the possibility of developing dizziness or visual symptoms (see Sections "Special Precautions" and "Adverse Reactions") while taking linezolid and advised not to drive or operate other machinery if these symptoms occur.
Overdose
There is no specific antidote.
No cases of overdose have been reported.
In case of overdose, symptomatic treatment is indicated, with measures to maintain glomerular filtration rate. Approximately 30% of the administered dose is removed during 3 hours of hemodialysis, but there are no data on the removal of linezolid during peritoneal dialysis or hemoperfusion. The two primary metabolites of linezolid are also removed by hemodialysis.
Side effects
The most common adverse reactions leading to drug withdrawal were headache, diarrhea, nausea, and vomiting.
Interaction
Linezolid is not used in patients taking drugs that inhibit monoamine oxidase A and B (e.g. phenelzine, isocarboxazid, selegiline, moclobemide), and within 2 weeks after taking them.
Storage conditions
Store in the original (primary and secondary) packaging to protect from light at a temperature not exceeding 30 °C.
Keep out of reach of children.
Shelf life - 2 years.
