| Dosage Form: | Powder Injection |
|---|---|
| Dossier: | Ready |
| Usfda: | Ready |
| Transport Package: | Carton |
| Specification: | 600mg |
| Trademark: | Sinolead |
| Samples: |
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| Customization: |
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Audited Supplier 
| Generic Name | Linezolid Tablets 600mg |
| Strength | 600mg |
| Packing | 10tabs/box |
| Origin | China |
This product is used to treat the following infections caused by specific microbial sensitive strains:
Hospital-acquired pneumonia, hospital-acquired pneumonia caused by Staphylococcus aureus (methicillin-sensitive and resistant strains) or Streptococcus pneumoniae.
Community-acquired pneumonia, community-acquired pneumonia caused by Streptococcus pneumoniae, including concomitant bacteremia, or community-acquired pneumonia caused by Staphylococcus aureus (only the methicillin-sensitive strain).
Complex skin and skin soft tissue infections, including diabetic foot infections without osteomyelitis, complex skin and skin soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive and resistant strains), Streptococcus pyogenes, or Streptococcus agalactis. There have been no studies on linezolid for the treatment of bedsores.
· Uncomplicated skin and skin soft tissue infections, caused by Staphylococcus aureus (only methicillin-sensitive strains) or Streptococcus pyogenes.
· Vancomycin-resistant enterococcus faecium infections, including concomitant bacteremia.
To reduce the occurrence of bacterial resistance and to ensure the efficacy of linezolid and other antimicrobial agents, Linezolid should only be used to treat or prevent infections caused by confirmed or highly suspected sensitive bacteria. If bacterial culture and drug sensitivity results are available, consideration should be given to selecting or adjusting antimicrobial therapy accordingly. In the absence of such data, local epidemiological data and drug sensitivity status may contribute to the selection of empiric treatment.
In controlled clinical studies, the safety and efficacy of linezolid preparations over 28 days have not been evaluated.
Linezolid is not indicated for the treatment of gram-negative infections. If a combination of gram-negative bacteria is confirmed or suspected, it is important to immediately begin targeted anti-gram-negative therapy (see warnings).
Usage and dosage:
Adult patients with MRSA infection are treated with linezolid 600 mg every 12 hours.
In limited clinical experience, 5 of 6 pediatric patients (83%) were treated with linezolid with a minimum inhibitory concentration of 4μg/ml against the gram-positive pathogen they were infected with and were clinically cured after treatment with linezolid. However, the range of changes in linezolid clearance and systemic drug exposure (AUC) was wider in pediatric patients than in adults. When the clinical efficacy of pediatric patients is not optimal, especially for pathogens with a minimum inhibitory concentration of 4μg/ml of linezolid, the relatively low systemic exposure, the site of infection and its severity, and the underlying disease should be considered in the evaluation of efficacy (see Pharmacokinetics - Special populations, children, and Pediatric use).
In controlled clinical studies, the protocol for treating infections ranges from 7 to 28 days. The total course of treatment is determined by the treating physician based on the site and severity of the infection and the patient's response to treatment.
To reduce the development of resistant bacteria and to ensure the efficacy of this product and other antimicrobial agents, linezolid should only be used to treat or prevent infectious diseases that have been confirmed or are highly suspected to be caused by bacteria.
warn
Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported in patients treated with linezolid. In cases with known outcomes, blood markers can rise and return to pre-treatment levels after discontinuation of linezolid. The risk of these effects appears to be related to the course of treatment. Older patients treated with linezolid have a higher risk of blood dysplasia than younger patients. Thrombocytopenia is more common in patients with severe renal insufficiency, whether or not they are on dialysis.
Complete blood counts should be performed weekly in patients receiving linezolid, especially those who have had anemia, granulocytopenia, thrombocytopenia, myelosuppression for more than two weeks or prior to treatment, or other medications that reduce hemoglobin levels, inhibit white blood cell count, adversely affect platelet count or function, or cause myelosuppression. Patients with severe renal insufficiency; Patients who have been on treatment for more than 10 to 14 days or who have a chronic infection and have been or are currently being treated with other antibiotics. Linezolid should only be used in these patients if hemoglobin levels, white blood cell counts, and platelet counts can be closely monitored.
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