Linezolid Canon, 10 pcs., 600 mg, film-coated tablets


Linezolid Canon, 10 pcs., 600 mg, film-coated tablets

In an open-label study of critically ill patients with intravascular catheter-associated infections, there was an excess of mortality in patients receiving linezolid compared with patients receiving vancomycin/dicloxacillin/oxacillin [78/363 (21.5%) vs 58/363 (16.5%). 0%)].

The main factor influencing mortality was the gram-positive pathogen at the initial stage. The mortality rate was similar among patients whose infections were caused only by gram-positive organisms, but was significantly higher in the linezolid group when other organisms were also detected or were not initially detected. The greatest imbalance was noted during treatment and within 7 days after the end of antibiotic therapy. Many patients in the linezolid group developed Gram-negative organisms during the study and died from Gram-negative or polymicrobial infections.

Therefore, for complicated skin and soft tissue infections, linezolid should be used in patients with known or possible co-infection with Gram-negative organisms only if no alternative treatment options are available. In these cases, additional use of drugs acting on gram-negative microflora is simultaneously indicated.

Some patients taking linezolid may develop reversible myelosuppression (with anemia, thrombocytopenia, leukopenia and pancytopenia), depending on the duration of therapy.

Older patients are also at increased risk of developing this condition.

Thrombocytopenia occurred more often in patients with severe renal failure, regardless of the patient's use of hemodialysis. In this regard, during treatment it is necessary to monitor blood counts in patients with an increased risk of bleeding, a history of myelosuppression, as well as with simultaneous use of drugs that reduce hemoglobin or platelet count and/or their functional properties, with severe renal failure, as well as in patients taking linezolid for more than 2 weeks. Linezolid is used in such patients only when close monitoring of hemoglobin, white blood cell and platelet counts is possible.

If significant myelosuppression develops during linezolid therapy, treatment should be discontinued unless continued therapy is considered absolutely necessary. In this case, intensive monitoring of blood counts and appropriate treatment are necessary.

In addition, it is recommended that blood tests (including hemoglobin, platelet count, and white blood cell count (with leukocyte count calculation)) be performed weekly in patients receiving linezolid, regardless of baseline blood test values.

A higher incidence of severe anemia was observed in patients receiving linezolid for more than the maximum recommended duration of 28 days. These patients were more likely to require blood transfusions.

Cases of sideroblastic anemia have been reported in the post-marketing period. In most cases, the duration of linezolid therapy exceeded 28 days. In most patients, symptoms were fully or partially reversible after discontinuation of linezolid treatment with or without specific anemia treatment.

In patients taking antibacterial drugs, including linezolid, the risk of developing pseudomembranous colitis of varying severity should be considered. Cases of Clostridium difficile-associated diarrhea have been reported in association with the use of virtually all antibacterial drugs, including linezolid. The severity of diarrhea can vary from mild to severe. Treatment with antibacterial drugs disrupts the normal intestinal microflora, which leads to excessive growth of Clostridium difficile. Clostridium difficile produces toxins A and B, which lead to Clostridium difficile-associated diarrhea. Excessive amounts of toxins produced by Clostridium difficile strains may cause increased mortality in patients, as such infections may be resistant to antimicrobial therapy and may require colectomy. Do not use medications that inhibit intestinal motility. The possibility of developing Clostridium difficile-associated diarrhea should be considered in all patients with diarrhea following antibiotic use. Close medical observation for 2 months is necessary for patients who experience diarrhea associated with Clostridium difficile after administration of antibacterial drugs.

If symptoms of deterioration in visual function appear, such as changes in visual acuity, changes in color perception, blurred vision, visual field defects, it is recommended to immediately consult an ophthalmologist for consultation. Visual function should be monitored in all patients taking linezolid long-term (more than 28 days) and in all patients with new-onset visual symptoms, regardless of the duration of therapy.

In the event of development of peripheral neuropathy and optic neuropathy, the risk/benefit ratio of continuing linezolid therapy in these patients should be assessed. The risk of developing neuropathy is higher if linezolid is used in patients who are currently using or who have recently taken antimycobacterial drugs to treat tuberculosis.

Lactic acidosis has been reported in association with linezolid use. Patients who experience repeated nausea or vomiting, abdominal pain, unexplained acidosis, or a decrease in bicarbonate anion concentrations while taking linezolid require careful monitoring by a physician.

Linezolid inhibits mitochondrial protein synthesis. Side effects such as lactic acidosis, anemia and neuropathy (peripheral and optic) may occur as a result of this inhibition; these effects are more common when the drug is used for more than 28 days.

Convulsions have been reported in patients taking linezolid, with most cases having a history of convulsions or risk factors for their development. Patients should obtain a detailed history regarding previous episodes of seizures.

If it is necessary to use the drug in combination with selective serotonin reuptake inhibitors, patients should be constantly monitored to identify signs and symptoms of serotonin syndrome, such as impaired cognitive function, hyperpyrexia, hyperreflexia and impaired motor coordination. If these symptoms appear, one or both medications should be discontinued. When you stop taking a serotonergic drug, symptoms of “diabetic moaning” syndrome, pressure ulcers or ischemic disorders, severe burns or gangrenous lesions may occur. Thus, experience with linezolid in the treatment of these conditions is limited.

Linezolid

In an open-label study of critically ill patients with intravascular catheter-associated infections, there was an excess of mortality in patients receiving linezolid compared with patients receiving vancomycin/dicloxacillin/oxacillin [78/363 (21.5%) vs 58/363 (16.5%). 0%)].

The main factor influencing mortality was the gram-positive pathogen at the initial stage. The mortality rate was similar among patients whose infections were caused only by gram-positive organisms, but was significantly higher in the linezolid group when other organisms were also detected or were not initially detected. The greatest imbalance was noted during treatment and within 7 days after the end of antibiotic therapy. Many patients in the linezolid group developed Gram-negative organisms during the study and died from Gram-negative or polymicrobial infections. Therefore, for complicated skin and soft tissue infections, linezolid should be used in patients with known or possible co-infection with Gram-negative organisms only if no alternative treatment options are available. In these cases, additional use of drugs acting on gram-negative microflora is simultaneously indicated.

Some patients taking linezolid may develop reversible myelosuppression (with anemia, thrombocytopenia, leukopenia and pancytopenia), depending on the duration of therapy. Older patients are also at increased risk of developing this condition. Thrombocytopenia occurred more often in patients with severe renal failure, regardless of the patient's use of hemodialysis. In this regard, during treatment it is necessary to monitor blood counts in patients with an increased risk of bleeding, a history of myelosuppression, as well as with simultaneous use of drugs that reduce hemoglobin or platelet count and/or their functional properties, with severe renal failure, as well as in patients taking linezolid for more than 2 weeks. Linezolid is used in such patients only when close monitoring of hemoglobin, white blood cell and platelet counts is possible. If significant myelosuppression develops during linezolid therapy, treatment should be discontinued unless continued therapy is considered absolutely necessary. In this case, intensive monitoring of blood counts and appropriate treatment are necessary. In addition, it is recommended that blood tests (including hemoglobin, platelet count, and white blood cell count (with leukocyte count calculation)) be performed weekly in patients receiving linezolid, regardless of baseline blood test values. A higher incidence of severe anemia was observed in patients receiving linezolid for more than the maximum recommended duration of 28 days. These patients were more likely to require blood transfusions. Cases of sideroblastic anemia have been reported in the post-marketing period. In most cases, the duration of linezolid therapy exceeded 28 days. In most patients, manifestations were completely or partially reversible after discontinuation of linezolid treatment with or without specific anemia treatment.

In patients taking antibacterial drugs, including linezolid, the risk of developing pseudomembranous colitis of varying severity should be considered. Cases of Clostridium difficile-associated diarrhea have been reported in association with the use of virtually all antibacterial drugs, including linezolid. The severity of diarrhea can vary from mild to severe. Treatment with antibacterial drugs disrupts the normal intestinal microflora, which leads to excessive growth of Clostridium difficile. Clostridium difficile produces toxins A and B, which lead to Clostridium difficile-associated diarrhea. Excessive amounts of toxins produced by Clostridium difficile strains may cause increased mortality in patients, as such infections may be resistant to antimicrobial therapy and may require colonectomy. Do not use medications that inhibit intestinal motility. The possibility of developing Clostridium difficile-associated diarrhea should be considered in all patients with diarrhea following antibiotic use. Close medical observation for 2 months is necessary for patients who experience diarrhea associated with Clostridium difficile after administration of antibacterial drugs.

If symptoms of deterioration in visual function appear, such as changes in visual acuity, changes in color perception, blurred vision, visual field defects, it is recommended to immediately consult an ophthalmologist for consultation. Visual function should be monitored in all patients taking linezolid long-term (more than 28 days) and in all patients with new-onset symptoms of visual impairment, regardless of the duration of therapy.

In the event of development of peripheral neuropathy and optic neuropathy, the risk/benefit ratio of continuing linezolid therapy in these patients should be assessed. The risk of developing neuropathy is higher if linezolid is used in patients who are currently using or who have recently taken antimycobacterial drugs to treat tuberculosis.

Lactic acidosis has been reported in association with linezolid use. Patients who experience repeated nausea or vomiting, abdominal pain, unexplained acidosis, or a decrease in bicarbonate anion concentrations while taking linezolid require careful monitoring by a physician.

Linezolid inhibits mitochondrial protein synthesis. Side effects such as lactic acidosis, anemia, and neuropathy (peripheral or optic) may result from this inhibition; these effects are more common when the drug is used for more than 28 days.

Convulsions have been reported in patients taking linezolid, with most cases having a history of convulsions or risk factors for their development. Patients should obtain a detailed history regarding previous episodes of seizures.

If it is necessary to use the drug in combination with selective serotonin reuptake inhibitors, patients should be constantly monitored to identify signs and symptoms of serotonin syndrome, such as impaired cognitive function, hyperpyrexia, hyperreflexia and impaired motor coordination. If these symptoms appear, one or both medications should be discontinued. When you stop taking a serotonergic drug, symptoms of diabetic foot syndrome, pressure ulcers or ischemic disorders, severe burns or gangrenous lesions may occur. Thus, experience with linezolid in the treatment of these conditions is limited.

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** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use Linezolid-Teva, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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