Lizolid-600 (linezolid) coated tablets 600 mg. №10

Description

Lizolid-600 composition
active substance: linezolid;
1 film-coated tablet contains 600 mg of linezolid;
excipients: microcrystalline cellulose; sodium starch glycolate (type A); povidone; castor oil polyethoxylated, hydrogenated; crospovidone; colloidal anhydrous silica; magnesium stearate; hydroxypropylmethylcellulose; talc; titanium dioxide (E 171); polyethylene glycol 6000.

Dosage form
Film-coated tablets.

Pharmacological properties
This drug Lizolid-600 belongs to the group of antibacterial drugs intended for systemic use.
The active component of this drug is linezolid, a synthetic antibacterial agent, which is part of the group of a new class of antimicrobial drugs – oxazolidinins.
Shows activity in in vitro application against gram-positive aerobic, anaerobic, as well as a certain amount of gram-negative bacteria and microorganisms.
Linezolid has the unique ability to selectively inhibit protein synthesis within bacterial cells.
Some types of enterococci, streptococci, staphylococci, as well as clostridia and other anaerobes with gram-positive activity are sensitive to linezolid. Shows efficiency in the fight against some resistant microorganisms – hemophilic infection, others.

Indications
This drug Lizolid-600 is used in the treatment of infections caused by sensitive anaerobic and aerobic gram-positive microorganisms, including those associated with bacteremia. In particular, such as:

• nosocomial pneumonia;
• community-acquired pneumonia;
• complicated infections of the skin and its structures, in particular infections against the background of a diabetic foot without concomitant osteomyelitis, caused by Staphylococcus aureus (methicillin-sensitive and methicillin isolates), Streptococcus pyogenes or Streptococcus agalactiae;
• uncomplicated infections of the skin and its structures caused by Staphylococcus aureus (only methicillin-sensitive isolates) or Streptococcus pyogenes;
• infections caused by enterococci, including vancomycin-resistant strains of Enterococcus faecium and faecalis.

If infectious agents include gram-negative organisms, combination therapy is recommended.

Contraindications
Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
It is also contraindicated in:

• uncontrolled arterial hypertension;
• pheochromocytoma;
• carcinoid;
• thyrotoxicosis;
• bipolar depression;
• schizoaffective disorder;
• attacks of dizziness.

The simultaneous administration of any drugs that inhibit monoamine oxidase A and B (in particular phenelzine, isocarboxazid, selegiline, moclobemide), or within two weeks after taking such drugs, is contraindicated.
It is not recommended to take it simultaneously with drugs – serotonin reuptake inhibitors, tricyclic antidepressants, 5-HT 1 serotonin receptor agonists (tryptans), direct and indirect sympathomimetics (including adrenergic bronchodilators, pseudoephedrine, phenylpropanolamine) (epinephenergic drugs) dopamine, dobutamine), pethidine or buspirone.

Children
It is not used in pediatrics until the age of 12.

Application during pregnancy and lactation
Not intended for use in pregnant women.
Also not used during lactation.

Method of administration and dosage
This drug Lizolid-600 is recommended to take 1 tablet of 600 mg 2 times a day, regardless of food intake.
The duration of treatment is determined by the attending physician, depending on the response of the patient’s body to treatment, the course of the disease.
The maximum duration of treatment is 28 days.
Recommended duration of treatment for:

• hospital and community-based pneumonia, complicated infections of the skin and its structures – 10-14 days;
• infections caused by Enterococcusfaecium resistant to vancomycin, in particular infections accompanied by bacteremia – from 14 to 28 days.

In the treatment of uncomplicated infections of the skin and its structures, the dosage for adults can be reduced to 400 mg 2 times a day, the duration of treatment is 10-14 days.
Elderly patients and patients with renal and hepatic insufficiency do not need to adjust the dosage and duration of treatment with this drug.

Overdose
Cases of overdose with this drug have not yet been observed.
In case of overdose, it is recommended to use hemodialysis to remove the drug from the body.

Side effects
Therapy with this drug can cause side reactions in the form of:

• oral, vaginal candidiasis, fungal infections, vaginitis, colitis, including pseudomembranous;
• eosinophilia, leukopenia, neutropenia, thrombocytopenia, myelosuppression, pancytopenia, sideroblastic anemia;
• anaphylactic shock;
• lactic acidosis, hyponatremia;
• insomnia;
• headache, taste perversion, dizziness, hypesthesia, paresthesia, serotonin syndrome, seizures, peripheral neuropathy;
• visual impairment, optic neuritis, optic neuropathy, changes in color perception, visual sensations, visual field defect;
• ringing in the ears;
• arrhythmias, tachycardia;
• arterial hypertension, phlebitis, thrombophlebitis, transient ischemic attack;
• diarrhea, nausea, vomiting, abdominal pain, constipation, dry mouth, dyspepsia, gastritis, bloating, glossitis, loose stools, pancreatitis, stomatitis, discoloration of the tongue;
• polyuria, renal failure;
• other adverse reactions.

Storage conditions and periods
The shelf life of the drug is no more than 2 years from the production date indicated on the package.
Store in a dry place out of the reach of children, at a temperature not exceeding 25 ° C.