Levofloxacin Mesylate for Injection

This product is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase (bacterial topoisomerase II) and hinder the replication of bacterial DNA to achieve antibacterial effect. This product has the characteristics of broad antibacterial spectrum and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter, and Gram-negative bacteria such as Pseudomonas aeruginosa, Haemophilus influenzae, and Neisseria gonorrhoeae. It also has good antibacterial effect on some methicillin-sensitive Staphylococci, Streptococcus pneumoniae, Streptococcus pyogenes, hemolytic Streptococci, and Legionella, Mycoplasma, and Chlamydia, but has poor effect on anaerobic bacteria and enterococci.

The main ingredients of this product are: Levofloxacin mesylate

This product is a yellow or yellow-green clear liquid.

To reduce the emergence of drug-resistant bacteria and ensure the effectiveness of levofloxacin mesylate and other antimicrobial drugs, levofloxacin is only used to treat or prevent infections that have been proven or highly suspected to be caused by sensitive bacteria. The results of bacterial culture and drug sensitivity tests should be considered when selecting or modifying antimicrobial treatment regimens. If there are no data from these tests for reference, empirical treatment should be carried out based on local epidemiology and pathogen sensitivity. Before treatment, bacterial culture and drug sensitivity tests should be performed to isolate and identify the infecting pathogens and determine their sensitivity to levofloxacin mesylate. Levofloxacin can be used for treatment before the above test results are obtained, and appropriate treatment methods can be selected after the test results are obtained. Like other drugs in this class, some strains of Pseudomonas aeruginosa can quickly develop drug resistance when levofloxacin mesylate is used for treatment. Bacterial culture and drug sensitivity tests should be performed regularly during treatment to understand whether the pathogens are continuously sensitive to antimicrobial drugs and to detect drug resistance in a timely manner after the bacteria develop resistance. Levofloxacin mesylate oral preparations and injections can be used to treat the following mild, moderate and severe infections caused by sensitive strains of the following bacteria in adults (≥18 years old). Levofloxacin mesylate injection can be used when intravenous drip is more beneficial to the patient (such as the patient cannot tolerate oral administration, etc.). 1. Hospital-acquired pneumonia is used to treat hospital-acquired pneumonia caused by methicillin-sensitive Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae or Streptococcus pneumoniae. At the same time, other auxiliary treatment measures should be taken according to clinical needs. If Pseudomonas aeruginosa infection has been proven or suspected, it is recommended to combine anti-pseudomonal β-lactam drugs for treatment. 2. 7-14-day treatment regimen for community-acquired pneumonia: Treatment of community-acquired pneumonia caused by methicillin-sensitive Staphylococcus aureus, Streptococcus pneumoniae [including multidrug-resistant strains (MDRSP*)], Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumococcus, or Mycoplasma pneumoniae. Note: MDRSP (multidrug-resistant Streptococcus pneumoniae) refers to strains resistant to two or more of the following antimicrobial drugs: penicillin (MIC ≥ 2µg/mL), second-generation cephalosporins (such as cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. 5-day treatment regimen: Treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydia pneumoniae. 3. 5-day treatment regimen for acute bacterial sinusitis: Treatment of acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. 10-14 days treatment plan: Treatment of acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. 4. Acute bacterial exacerbations of chronic bronchitis Treatment of acute bacterial exacerbations of chronic bronchitis caused by methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. 5. Complicated skin and skin structure infections Treatment of complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis. 6. Uncomplicated skin and skin and soft tissue infections Treatment of uncomplicated skin and skin structure infections (mild to moderate) caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes, including abscesses, cellulitis, furuncle, impetigo, pyoderma, and wound infections. 7. Chronic bacterial prostatitis Treatment of chronic bacterial prostatitis caused by Escherichia coli, Enterococcus faecalis, or methicillin-sensitive Staphylococcus epidermidis. 8. 5-day treatment regimen for complicated urinary tract infection: Treatment of complicated urinary tract infection caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. 10-day treatment regimen: Treatment of complicated urinary tract infection (mild to moderate) caused by Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa. 9. 5-day treatment regimen for acute pyelonephritis: Treatment of acute pyelonephritis caused by Escherichia coli, including names with bacteremia. 10-day treatment regimen: Treatment of acute pyelonephritis caused by Escherichia coli, including names with bacteremia. 10. Uncomplicated urinary tract infection: Treatment of uncomplicated urinary tract infection (mild to moderate) caused by Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. 11. Inhalation anthrax (post-exposure) is indicated for the treatment of inhalation anthrax (post-exposure), to reduce the occurrence of the disease or slow the progression of the disease after exposure to anthrax spray. The effectiveness of levofloxacin is based on the human plasma concentration as a surrogate endpoint to predict clinical efficacy. The preventive effect of levofloxacin after anthrax inhalation exposure has not been tested in humans. The safety of levofloxacin for treatment of more than 28 days in adults has not been studied. Levofloxacin can only be used for long-term treatment when the benefits outweigh the risks.

This product should be prepared before use. First dissolve it with 5-10ml of 5% glucose injection or 5% glucose sodium chloride injection, then add it to 100ml of 5% glucose injection or 5% glucose sodium chloride injection for intravenous drip. This preparation is specially for intravenous drip, and the drip time is at least 60 minutes for every 100ml. This preparation should not be mixed with other drugs in the same bottle for intravenous drip, or for intravenous drip in one intravenous infusion line. Recommended dose: 400mg per day for adults, divided into 2 intravenous drips. For patients with severe infections and those with poor sensitivity of pathogens to this product (such as Pseudomonas aeruginosa), the maximum daily dose can be increased to 600mg, divided into 2 intravenous drips. For patients with impaired renal function, the dosage is determined according to the creatinine clearance rate. Creatinine clearance 50-80ml/minNormal dose 20-49ml/minFirst dose 400mg, then 200mg every 24 hours10-19ml/minFirst dose 400mg, then 200mg every 48 hours

During medication, you may experience symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, and bloating; neurological symptoms such as insomnia, dizziness, and headache; rash, itching, erythema, and redness and itching at the injection site, or phlebitis. Transient liver function abnormalities may also occur, such as increased blood transaminase and increased serum total bilirubin. The incidence of the above adverse reactions is between 0.1 and 5%. Occasionally, blood urea nitrogen rises, fatigue, fever, palpitations, and abnormal taste are seen, which are generally tolerated and disappear quickly after the end of the course of treatment.

It is contraindicated for patients who are allergic to quinolones, pregnant or lactating women, and patients under 18 years of age.

1. This product cannot be used in the same infusion tube with polyvalent metal ion solutions such as magnesium and calcium. Avoid using it simultaneously with theophylline. If it is necessary to use it simultaneously, the blood concentration of theophylline should be monitored and the dosage should be adjusted accordingly. 2. When used simultaneously with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 3. When used simultaneously with non-steroidal anti-inflammatory drugs, convulsions may be induced. 4. When used simultaneously with oral hypoglycemic drugs, hypoglycemia may be caused. Therefore, attention should be paid to monitoring blood sugar concentration during medication. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given.

Keep away from light and store in a sealed container.

0.3g (based on C18H20FN3O4)

Jilin Province Xidian Pharmaceutical Sci-Tech Development Co., Ltd.

• Founded in:

  1990-03-21

• Address:

  No. 777, Xidian Street, Panshi Economic Development Zone, Jilin Province

• Tax NO.:

  912202011239483018

• Registered Funds:

  76.494685 million yuan

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