Linessa tablets are 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, 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; infections caused by enterococci, including vancomycin-resistant strains of Enterococcus faecium and faecalis.
Composition
Active ingredient: linezolid.
1 film-coated tablet contains 600 mg of linezolid.
Excipients: microcrystalline cellulose; lactose, monohydrate; povidone; talc; croscarmellose sodium; magnesium stearate; colloidal anhydrous silica; sodium starch glycolate (type A); hypromellose E-15; titanium dioxide E 171; polyethylene glycol-6000; propylene glycol.
Contraindication
Known hypersensitivity to linezolid or any other component of the drug.
The drug should not be prescribed to patients who are taking or have taken any medications that inhibit monoamine oxidase A and B (e.g., phenelzine, isocarboxazid, selegiline, moclobemide) or within 2 weeks of taking such medications.
Unless close observation and monitoring of blood pressure is possible, the drug should not be prescribed to patients with the following concomitant clinical conditions or concomitant use of the following drugs:
uncontrolled hypertension, thyrotoxicosis, pheochromocytoma, carcinoid, bipolar depression, schizoaffective disorder, acute episodes of dizziness; serotonin reuptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 receptor agonists (triptans), direct and indirect sympathomimetics (including adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine), vasopressors (epinephrine, norepinephrine), dopaminergic compounds (dopamine, dobutamine), pethidine or buspirone.
Method of application
Patients initiated on intravenous linezolid may be switched to oral linezolid. In this case, no dose adjustment is necessary since the oral bioavailability of linezolid is nearly 100%.
Application features
Pregnant women
Should not be administered during pregnancy unless the expected benefit to the mother outweighs the potential risk to the fetus.
Children
The drug is not prescribed to children under 12 years of age.
Drivers
With caution.
Overdose
No specific antidote is known.
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 at a temperature not exceeding 25°C.
Keep out of reach of children.
Shelf life: 3 years.
