Buy Zivox (Linezolid)

The main active agent of linezolid is a protein synthesis inhibitor: these substances stop the growth and reproduction of bacteria by disrupting the translation of proteins on ribosomes. Although the mechanism of action is not fully understood, linezolid appears to act at the first step in protein synthesis—initiation—unlike most other protein synthesis inhibitors that interfere with elongation.

The drug does this by preventing the formation of an initiation complex consisting of the 30S and 50S subunits of the ribosome, tRNA, and mRNA. Linezolid binds to the 23S portion of the 50S subunit (peptidyl transferase site of action), adjacent to the binding site for chloramphenicol, lincomycin, and other antibiotics. Due to this unique mechanism of action, cross-resistance between linezolid and other protein synthesis inhibitors is very rare or non-existent.

Treatment of infectious inflammatory diseases known or suspected to be caused by linezolid-susceptible aerobic and anaerobic Gram-positive organisms (including infections accompanied by bacteremia):

• community-acquired pneumonia caused by Streptococcus pneumoniae (including multidrug-resistant strains), including cases accompanied by bacteremia, or Staphylococcus aureus (only methicillin-susceptible strains);
• nosocomial pneumonia caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains);
• complicated infections of the skin and soft tissues, including infections with diabetic foot syndrome, not accompanied by osteomyelitis, caused by Staphylococcus aureus (including methicillin-sensitive and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agalactiae;
• uncomplicated infections of the skin and soft tissues caused by Staphylococcus aureus (only methicillin-sensitive strains) or Streptococcus pyogenes;
• vancomycin-resistant infections caused by Enterococcus faecium, including those accompanied by bacteremia.

Adverse events associated with taking linezolid are usually mild or moderate in severity. Diarrhea, headache and nausea are the most common.

Adult patients.

• From the digestive system: often diarrhea, nausea, vomiting, constipation, abdominal pain (including spastic), flatulence, candidiasis of the oral mucosa; infrequent change in coloration of the tongue.
• Laboratory indicators: often thrombocytopenia; infrequently, an increase in the concentration of triglycerides in the blood, an increase in the activity of “liver” enzymes (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), lactate dehydrogenase (LDH), lipase, amylase, concentrations of total bilirubin and creatinine), an increase in the concentration of prolactin.
• From the nervous system: often headache, dizziness, convulsions; infrequently a perversion of taste.
• From the side of the central nervous system: often insomnia.
• From the genitourinary system: often vaginal candidiasis.
• On the part of the skin: often rash.
• Other: often fever; infrequently opportunistic fungal infection.
• Also were noted: increased blood pressure, dyspepsia, itching.

Teenagers (from 12 to 17 years old).

• From the digestive system: often diarrhea, nausea, vomiting, abdominal pain (local and generalized), loose stools.
• Laboratory indicators: infrequently, eosinophilia, an increase in the concentration of triglycerides in the blood, an increase in the activity of alanine aminotransferase (ALT), lipase, creatinine concentration.
• From the nervous system: often headache, vertigo.
• On the part of the skin: often a rash; not often itching.
• From the respiratory system: often infections of the upper respiratory tract, pharyngitis, cough.
• Other: often fever, pain of unspecified localization.

Spontaneous (post-marketing) data.

• Laboratory indicators: reversible myelosuppression (thrombocytopenia, anemia, leukopenia, pancytopenia)
• From the senses: cases of optic neuropathy, sometimes leading to loss of vision.
• Allergic reactions: anaphylaxis.
• From the side of the skin: rash, angioedema; bullous skin lesions similar to Stevens-Johnson syndrome.
• From the nervous system: peripheral neuropathy, convulsions.
• From the digestive system: discoloration of tooth enamel.
• Other: chills, fatigue, serotonin syndrome

• Hypersensitivity to linezolid and / or other components of the drug.
• Hypersensitivity to aspartame. Phenylketonuria.
• Concomitant use of linezolid with drugs that inhibit monoamine oxidase A or B (for example, phenelzine, isocarboxazid), as well as within two weeks after stopping these drugs.
• In the absence of blood pressure monitoring, linezolid should not be administered to patients with uncontrolled hypertension, pheochromocytoma, thyrotoxicosis, and/or patients receiving the following types of drugs: adrenomimetics (eg, pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine), dopaminomimetics (eg, dopamine).
• In the absence of careful monitoring of patients with possible development of serotonin syndrome, linezolid should not be administered to persons with carcinoid syndrome and / or patients receiving the following drugs: serotonin reuptake inhibitors, tricyclic antidepressants, 5-HT1 receptor agonists (triptans), meperidine or buspirone.
• The use of linezolid in children under 12 years of age in the form of tablets is contraindicated due to the impossibility of an adequate dose selection.

CAREFULLY.

• Patients with renal insufficiency. Due to the unexplored clinical relevance of linezolid's two primary metabolites in patients with severe renal impairment, linezolid should be used with caution in such patients and only if the potential benefit outweighs the potential risk.
• There are also no data on the use of linezolid in patients on ambulatory peritoneal dialysis or other alternative treatments for renal failure.
• Patients with liver failure. There are limited clinical data recommending the use of linezolid in these patients only if the perceived benefit outweighs the potential risk.
• Linezolid should be used with caution in patients with life-threatening systemic infections such as those associated with venous catheters in intensive care units.

USE IN PREGNANCY AND DURING BREASTFEEDING.

There have been no studies on the safety of linezolid during pregnancy, so the use of ZIVOX during pregnancy is possible only if the expected benefit of therapy for the mother outweighs the potential risk to the fetus. It is not known whether linezolid is excreted in the breast milk of lactating women, so breastfeeding should be discontinued when prescribing the drug to the mother during lactation.

The drug can be taken both during meals and between meals. Patients who received the drug intravenously at the beginning of therapy can later be transferred to any dosage form of the drug for oral administration, while dose selection is not required, because. The bioavailability of linezolid when taken orally is almost 100%.

The duration of treatment depends on the pathogen, the location and severity of the infection, as well as the clinical effect.

Adults and children (12 years and older):

• community-acquired pneumonia caused by Streptococcus pneumoniae (including multi-resistant strains), including cases accompanied by bacteremia, or Staphylococcus aureus (methicillin-susceptible strains only): 600 mg orally every 12 hours, duration of treatment 10-14 days.
• nosocomial pneumonia caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) or Streptococcus pneumoniae (including multidrug-resistant strains): 600 mg orally every 12 hours, duration of treatment 10-14 days.
• Complicated infections of the skin and soft tissues, including infections with diabetic foot syndrome, not accompanied by osteomyelitis, caused by Stapfiybcoccus aureus (including methicillin-sensitive and methicillin-resistant strains), Streptococcus pyogenes or Streptococcus agaluctiae: 600 mg orally every 12 hours, duration of treatment 10-14 days.
• Uncomplicated skin and soft tissue infections caused by Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes: adults: 600 mg orally every 12 hours, duration of treatment 10-14 days.
•  infections caused by Enterococcus faecium resistant to vancomycin, including those accompanied by bacteremia: 600 mg orally every 12 hours, duration of treatment 14-28 days.

Elderly patients: dose adjustment is not required.

Patients with renal insufficiency: dose adjustment is not required. Due to the fact that 30% of linezolid is removed by hemodialysis within 3 hours, linezolid should be taken after dialysis in patients requiring it.

Patients with hepatic insufficiency: dose adjustment is not required.

Drugs such as warfarin and phenytoin, which are substrates of the CYP2C9 isoenzyme, can be used simultaneously with linezolid without dose adjustment.

Monoamine oxidase inhibitors.

Linezolid is a non-selective reversible monoamine oxidase inhibitor, therefore, some patients receiving linezolid may experience a moderate reversible increase in the pressor effects of pseudoephedrine and phenylpropanolamine. In this regard, it is recommended to reduce the initial doses of the following groups of drugs: adrenomimetics (for example, pseudoephedrine, phenylpropanolamine, epinephrine, norepinephrine, dobutamine), dopaminomimetics (for example, dopamine) and further dose selection by titration. In phase I, II and III studies, the development of serotonin syndrome was not observed in patients who received linezolid in conjunction with serotonergic drugs. However, there have been several reports of the development of serotonin syndrome during the use of linezolid and antidepressants - selective serotonin reuptake inhibitors. With simultaneous use with aztreonam and gentamicin, no changes in the pharmacokinetics of linezolid were observed. Rifampicin caused a decrease in the maximum concentration and AUC of linezolid by an average of 21% and 32%, respectively.

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