Zivox solution for infusion is indicated for the 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; 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.
Composition
Active ingredient: linezolid;
1 ml of solution contains 2 mg of linezolid;
Excipients: sodium citrate dihydrate, citric acid, glucose monohydrate, sodium hydroxide, diluted hydrochloric acid, water for injections.
Contraindication
Known hypersensitivity to linezolid or any of the other ingredients of the product. The product should not be used in patients taking any drugs that inhibit monoamine oxidase A and B (e.g. phenelzine, isocarboxazid, selegiline, moclobemide), or within two weeks of taking such drugs.
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
The duration of treatment depends on the pathogen, location and severity of the infection, as well as the clinical effect.
The recommendations for duration of therapy below were used in clinical trials.
The maximum duration of treatment is 28 days.
Application features
Pregnant women
The drug should not be used 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 while taking linezolid and advised not to drive or operate 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 discontinuation were headache, diarrhea, nausea, and vomiting. Approximately 3% of patients discontinued treatment due to drug-related adverse reactions.
Interaction
Aztreonam: The pharmacokinetics of linezolid or aztreonam are not altered by co-administration of these drugs.
Gentamicin: The pharmacokinetics of linezolid or gentamicin are not altered by co-administration of these drugs.
When used simultaneously with vitamin C or vitamin E, dose adjustment of linezolid is not recommended.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
The contents of the package must be used immediately after opening.
Shelf life - 3 years.
