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Linezolid Tablets.

Effects and efficacy: This product is used to treat the following infections caused by sensitive strains of specific microorganisms: Nosocomial pneumonia: Nosocomial 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 (methicillin-sensitive strains only). Complicated skin and skin and soft tissue infections, including diabetic foot infections without concurrent osteomyelitis: Complicated skin and skin and soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive and -resistant strains), Streptococcus pyogenes, or Streptococcus agalactiae. There are no studies on the use of linezolid in the treatment of bedsores. Uncomplicated skin and skin and soft tissue infections: Uncomplicated skin and skin and soft tissue infections caused by Staphylococcus aureus (methicillin-sensitive strains only) or Streptococcus pyogenes. Vancomycin-resistant Enterococcus faecium infections, including concomitant bacteremia. To reduce the occurrence of bacterial resistance and ensure the efficacy of linezolid and other antimicrobial drugs, linezolid should only be used to treat infections caused by confirmed or highly suspected sensitive bacteria. If bacterial culture and drug sensitivity results are available, antimicrobial therapy should be selected or adjusted accordingly. If these data are lacking, local epidemiological data and drug sensitivity status may help choose empirical treatment. In controlled clinical studies, the safety and efficacy of linezolid preparations for more than 28 days have not been evaluated. Linezolid is not suitable for the treatment of Gram-negative infections. If Gram-negative infections are confirmed or suspected, it is important to start targeted anti-Gram-negative treatment immediately.
Usage and Dosage:
For specific usage and dosage for different populations and different diseases, please consult a doctor and refer to the drug instructions of different preparations. Adult patients with MRSA infection should be treated with linezolid 600 mg once every 12 hours. Intravenous linezolid glucose intravenous injection is a single-use, ready-to-use infusion bag. When administered intravenously, particulate matter should be visually inspected before use. Squeeze the infusion bag hard to check for minor leaks. Because sterility may be compromised, the solution should be discarded if leakage is detected. Linezolid IV Dextrose should be administered within 30 to 120 minutes. Do not connect this IV bag in series with other IV routes. Do not add other drugs to this solution. If linezolid IV Dextrose is to be used in combination with other drugs, each drug should be used separately according to the recommended dose and route of administration. In particular, it should be noted that linezolid IV Dextrose may be physically incompatible when co-administered with the following drugs through a Y-type interface. These drugs include: amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isothiosulfate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. In addition, linezolid IV Dextrose may be chemically incompatible when used in combination with ceftriaxone sodium. If the same intravenous line is used for the sequential administration of several drugs, flush with solutions compatible with linezolid dextrose and other drugs before and after the use of linezolid dextrose intravenous solution (see Compatible intravenous solutions). Compatible intravenous solutions: 5% dextrose injection, USP. 0.9% sodium chloride injection, USP. Lactated Ringer’s solution, USP. The outer packaging bag of the infusion bag can be removed only when in use. Store at room temperature and avoid freezing. Linezolid dextrose intravenous solution may be yellow, and it may darken over time but has no effect on the drug content.
Adverse reactions:
In adult patients, 2046 patients were enrolled in 7 phase III active drug-controlled clinical studies with a treatment duration of up to 28 days to evaluate the safety of linezolid. In patients treated for uncomplicated skin and skin and soft tissue infections (uSSSI), 25.4% of patients using linezolid and 19.6% of patients using control drugs experienced at least one drug-related adverse event. For all other indications, 20.4% of patients treated with linezolid and 14.3% of patients treated with comparators experienced at least one drug-related adverse event. In the studies, 85% of adverse events with linezolid were mild to moderate in severity. The most common adverse events with linezolid were diarrhea (2.8% to 11.0% in different studies), headache (0.5% to 11.3% in different studies), and nausea (3.4% to 9.6% in different studies). Other adverse events reported in Phase II and Phase III studies included oral candidiasis, vaginal candidiasis, hypertension, dyspepsia, local abdominal pain, pruritus, and tongue discoloration. In active-controlled clinical studies of linezolid, treatment-emergent in adult patients treated for uSSSI discontinued treatment due to drug-related adverse events in 3.5% of patients treated with linezolid and 2.4% of patients treated with comparators. For all other indications, 2.1% of patients taking linezolid and 1.7% of patients taking comparators discontinued treatment due to drug-related adverse events. The most common drug-related adverse events leading to discontinuation were nausea, headache, diarrhea, and vomiting. Adverse drug reactions that occurred at a frequency of ≥ 0.1% or were considered serious in clinical studies. These studies enrolled a total of 2000 adult patients who received linezolid at recommended doses for up to 28 days. Approximately 22% of patients experienced adverse reactions; the most common were headache (2.1%), diarrhea (4.2%), nausea (3.3%), and candidiasis (particularly oral candidiasis [0.8%] and vaginal candidiasis [1.1%]). The most common drug-related adverse events leading to treatment discontinuation were headache, diarrhea, nausea, and vomiting. Approximately 3% of patients discontinued treatment due to drug-related adverse events. Anemia was reported in less than 0.1% of patients in controlled clinical trials of linezolid for up to 28 days. In patients with life-threatening infections and underlying comorbidities who received linezolid under the compassionate use program, anemia occurred in 2.5% (33/1326) of patients at ≤28 days compared to 12.3% (53/430) of patients treated for >28 days. Drug-related severe anemia requiring transfusion was reported in 9% (3/33) of patients treated for ≤28 days and 15% (8/53) of patients treated for >28 days. Pediatric Patients Safety data based on clinical studies in approximately 500 pediatric patients (from birth to 17 years of age) did not indicate that the safety profile of linezolid in pediatric patients differs from that in adults. The safety of linezolid was evaluated in 215 pediatric patients aged birth to 11 years and 248 pediatric patients aged 5 to 17 years (146 of whom were 5 to 11 years of age and 102 of whom were 12 to 17 years of age). Patients were enrolled in two Phase III active-controlled clinical studies with a maximum of 28 days of treatment. In the study, 83% and 99% of the adverse events reported in the linezolid group were classified as mild or moderate in severity. In a study of hospitalized pediatric patients with Gram-positive infections (patients aged from birth to 11 years), patients were randomized 2:1 to linezolid vs vancomycin, and the mortality rate was 6.0% (13/215) in the linezolid group and 3.0% (3/101) in the vancomycin group. Given the serious underlying medical conditions in these patients, a causal relationship could not be established. In pediatric patients treated for uSSSI, 19.2% of patients treated with linezolid and 14.1% of patients treated with the comparator experienced at least one drug-related adverse event. For all other indications, 18.8% of patients treated with linezolid and 34.3% of patients treated with the comparator experienced at least one drug-related adverse event. Pediatric patients 5 to 11 years: linezolid 10 mg/kg orally every 12 hours or cefadroxil 15 mg/kg orally every 12 hours. Pediatric patients 12 years or older: linezolid 600 mg orally every 12 hours or cefadroxil 500 mg orally every 12 hours. Pediatric patients from birth to 11 years: linezolid 10 mg/kg orally or intravenously every 8 hours; vancomycin 10-15 mg/kg intravenously every 6-24 hours depending on age and renal clearance. In pediatric patients treated for uSSSI, 1.6% of patients treated with linezolid and 2.4% of patients treated with the comparator discontinued treatment due to drug-related adverse events. For all other indications, 0.9% of patients treated with linezolid and 6.1% of patients treated with the comparator discontinued treatment due to drug-related adverse events. Laboratory Changes Linezolid has been associated with thrombocytopenia at doses up to 600 mg every 12 hours for up to 28 days. In active-controlled phase III clinical studies, the percentage of adults with marked thrombocytopenia (defined as less than 75% of normal or baseline) was 2.4% in the linezolid group (range, 0.3%-10.0%) and 1.5% in the control group (range, 0.4%-7.0%). In a study of hospitalized pediatric patients aged birth to 11 years, the percentage of patients with marked thrombocytopenia (defined as less than 75% of normal or baseline) was 12.9% in the linezolid group and 13.4% in the vancomycin group. In another study of outpatient pediatric patients aged 5 to 17 years, the percentage of patients with marked thrombocytopenia (defined as less than 75% of normal or baseline) was 0% in the linezolid group and 0.4% in the cefadroxil group. Linezolid-associated thrombocytopenia appears to be related to the duration of treatment (usually for more than 2 weeks). Platelet counts returned to normal/basal levels in most patients during the follow-up period. In Phase III clinical studies, no clinically relevant adverse events were observed in patients with thrombocytopenia. Bleeding events were only seen in patients with thrombocytopenia in the linezolid compassionate use program; the role of linezolid in these adverse events cannot be determined. Post-marketing experience Bone marrow suppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia); sideroblastic anemia. Peripheral neuropathy and optic neuropathy, sometimes progressing to visual loss. Lactic acidosis. Although the above reports mainly occurred in patients who used linezolid for more than the recommended maximum application time (28 days), they have also been reported in patients with shorter medication durations. Serotonin syndrome has been reported in patients who have taken linezolid in combination with serotonergic drugs, including antidepressants such as selective serotonin reuptake inhibitors (SSRIs). Convulsions. Anaphylactic reactions, angioedema, and skin blisters, including severe cutaneous adverse reactions (SCARs), such as toxic epidermal necrolysis and Stevens-Johnson syndrome. There have been reports of tooth and tongue discoloration after linezolid use. In cases with known results, tooth discoloration can be removed by professional dental cleaning (manual descaling). Hypoglycemia, including symptomatic onset. These adverse events may be listed due to their severity, frequency of reporting, possible relevance to linezolid, or a combination of these factors. Because the above events are spontaneously reported, it is unknown how large a sample of patients they come from, so their incidence cannot be estimated, and their causal relationship with medication cannot be accurately determined.
Drug contraindications:
Allergic to this product is contraindicated and should be used with caution during lactation.

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