Gatifloxacin Mesylate Sodium Chloride Injection

Gatifloxacin is a racemic compound of 8-methoxyfluoroquinolone, which has a broad spectrum of activity against Gram-negative and Gram-positive microorganisms in vitro, and its R- and S-enantiomers have the same antibacterial activity. The antibacterial effect of this product is through inhibiting bacterial DNA gyrase and topoisomerase IV, thereby inhibiting bacterial DNA replication, transcription and repair processes. In vitro tests and clinical use results have shown that this product has antibacterial activity against most strains of the following microorganisms: 1. Gram-positive bacteria: Staphylococcus aureus (limited to strains sensitive to methicillin), Streptococcus pneumoniae (strains sensitive to penicillin). 2. Gram-negative bacteria: Escherichia coli, Haemophilus influenzae and parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Neisseria gonorrhoeae, Proteus mirabilis. 3. Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

Main ingredient: Gatifloxacin mesylate Chemical name: 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid methanesulfonate Molecular formula: C19H22FN3O4CH3SO3H Molecular weight: 471.50

Used to treat the following infectious diseases of moderate severity or above caused by sensitive strains: Acute exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis or Staphylococcus aureus. 1. Acute sinusitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, etc. 2. Community-acquired pneumonia: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Chlamydia pneumophila, Mycoplasma pneumophila or Legionella pneumophila, etc. 3. Simple or complicated urinary tract infection (cystitis): caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis. 4. Pyelonephritis: caused by Escherichia coli, etc. 5. Simple urethral and cervical gonorrhea: caused by Neisseria gonorrhoeae. 6. Female

Intravenous drip. 400 mg each time, once a day, please refer to the table below (Table 1) for details. This product is bioequivalent to oral tablets. During the course of treatment, it can be changed from intravenous administration to oral tablets according to the doctor's decision, and there is no need to adjust the dosage. Table 1. Dosage Guide Infection (depending on the pathogen) Daily dosage course of treatment Acute attack of chronic bronchitis 400 mg 7 to 10 days Acute sinusitis 400 mg 10 days Community-acquired pneumonia 400 mg 7 to 14 days Simple urinary tract infection 400 mg single dose or 200 mg 3 to 5 days Complicated urinary tract infection 400 mg 7 to 10 days Acute pyelonephritis 400 mg 7 to 10 days Male simple gonococcal urinary tract infection 400 mg single dose Female cervical and rectal gonococcal infection 400 mg single dose Infection (depending on the pathogen) Daily dose course of treatment: Acute exacerbation of chronic bronchitis 400mg7-10 days Acute sinusitis 400mg10 days Community-acquired pneumonia 400mg7-14 days Simple urinary tract infection 400mg single dose Or 200mg3-5 days Complex urinary tract infection 400mg7-10 days Acute pyelonephritis 400mg7-10 days Male simple gonococcal urinary tract infection 400mg single dose Female cervical and rectal gonococcal infection 400mg single dose Gatifloxacin is mainly excreted through the kidneys. Patients with creatinine clearance

Adverse reactions seen in clinical trials were mostly mild, mainly in the intravenous administration site and the gastrointestinal tract and nervous system, including phlebitis, nausea, vomiting, diarrhea, headache and dizziness. Other rare clinically related adverse events include: Systemic reactions: allergic reactions, chills, fever, back pain, chest pain, weakness and facial edema. Cardiovascular system: hypertension, palpitations. Digestive system: abdominal pain, constipation, indigestion, glossitis, candidal stomatitis, stomatitis, oral ulcers, vomiting, loss of appetite, gastritis and flatulence. Metabolic and nutritional system: peripheral edema, hyperglycemia and thirst. Musculoskeletal system: joint pain, painful cramps in the lower limbs. Nervous system: dreaminess, insomnia, paresthesia, tremor, vasodilation, dizziness, agitation, anxiety, confusion and tension. Respiration

This product is contraindicated in patients who are allergic to gatifloxacin or quinolones.

1. This product can be used in combination with probenecid to slow down the elimination of gatifloxacin through the kidney. 2. When this product is used simultaneously with digoxin, no significant changes in the pharmacokinetics of gatifloxacin are observed, but the blood concentration of digoxin is found to be increased in some subjects. Therefore, the symptoms and signs of digoxin toxicity in patients taking digoxin should be monitored. For patients who show symptoms and signs of toxicity, the blood concentration of digoxin should be measured and the digoxin dose should be adjusted appropriately. However, it is not recommended to adjust the doses of the two drugs in advance.

Keep in a light-proof and airtight container.

250ml: 0.4g (in terms of gatifloxacin) and 2.25g sodium chloride

Zhejiang Jingxin Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-13

• Address:

  No. 800, Xinchang Avenue East Road, Yulin Street, Xinchang County, Zhejiang Province

• Tax NO.:

  91330000704503984N

• Registered Funds:

  861.02914 million yuan

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