Gatifloxacin Capsules

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 to inhibit the DNA gyrase and topoisomerase IV of bacteria, thereby inhibiting the replication, transcription and repair process of bacterial DNA. The results of antibacterial experiments all show 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), coagulase-negative Staphylococcus, Streptococcus pneumoniae and other Streptococcus strains. 2. Gram-negative bacteria: Haemophilus (influenza and parainfluenza), Moraxella catarrhalis, Neisseria, Acinetobacter, Klebsiella pneumoniae, Enterobacter cloacae, Proteus (Proteus mirabilis and Proteus vulgaris), Pseudomonas aeruginosa, Citrobacter and Escherichia coli. 3. Other microorganisms: Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.

The main ingredient of this product is gatifloxacin, chemical name: (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(-3-methyl-1-piperazine)-4-keto-3-quinolinecarboxylic acid sesquihydrate. Chemical structure: Molecular formula: C19H22FN3O4·1.5H2O Molecular weight: 402.42

This product is a hard capsule, and the contents are off-white or light yellow granules.

This product is mainly used for various infectious diseases caused by sensitive pathogens, including acute exacerbation of chronic bronchitis, acute sinusitis, community-acquired pneumonia, simple urinary tract infection (cystitis) and complicated urinary tract infection, acute pyelonephritis, male gonococcal urinary tract inflammation or rectal infection and female gonococcal cervical infection.

Oral, once daily, 400 mg (2 tablets) each time. The recommended dose is shown in the table below (Table 1). Table 1 Dosage Guide Infection (depending on the pathogen) Daily dose Course of treatment Acute exacerbation of chronic bronchitis 400 mg 7-10 days Acute sinusitis 400 mg 10 days Community-acquired pneumonia 400 mg 7-14 days Simple urinary tract infection 400 mg single dose or 200 mg 3-5 days Complicated urinary tract infection 400 mg 7-10 days Acute pyelonephritis 400 mg 7-10 days Male simple gonococcal urinary tract infection 400 mg single dose Female cervical and rectal gonococcal infection 400 mg single dose Gatifloxacin is mainly excreted through the kidneys. Patients with creatinine clearance < 40 ml/min, including hemodialysis and long-term peritoneal dialysis patients, should adjust the dose of this product. Hemodialysis patients should take the drug after each hemodialysis. The dosage and administration for patients with renal insufficiency can refer to the following table (Table 2). Table 2 Recommended dosage for patients with renal insufficiency Recommended dosage of this product for patients with renal insufficiency Creatinine clearance Initial dosage Maintenance dosage ≥40ml/min400mg400mg/day<40ml/min400mg200mg/day Hemodialysis 400mg200mg/day Peritoneal dialysis 400mg200mg/day Maintenance dosage starts from the second day of medication Patients with renal insufficiency use a single dose of 400mg to treat simple urinary tract infection or gonorrhea, and 200mg daily for 3 days to treat simple urinary tract infection. There is no need to adjust the dosage of this product.

Common adverse reactions in domestic and international clinical trials of this product are nausea, vaginitis, diarrhea, headache, and dizziness. Drug-related adverse events with lower incidences include: Systemic reactions: allergic reactions, chills, fever, back pain, and chest pain. Cardiovascular system: palpitations. Digestive system: abdominal pain, constipation, indigestion, glossitis, candidal stomatitis, stomatitis, oral ulcers, and vomiting. Metabolic and nutritional system: peripheral edema. Nervous system: dreaminess, insomnia, paresthesia, tremor, vasodilation, and dizziness. Respiratory system: dyspnea, pharyngitis. Skin and soft tissue: rash, sweating. Special senses: abnormal vision, abnormal taste, and tinnitus. Urogenital system: dysuria, hematuria. Other rare related adverse reactions

This product is contraindicated for patients who are allergic to gatifloxacin or quinolones. It is contraindicated for patients with diabetes.

Precautions for children: The efficacy and safety of this drug for children or adolescents under 18 years of age have not been established, and its use is not recommended. Precautions for pregnancy and lactation: The efficacy and safety of this drug for pregnant and lactating women have not been established, and pregnant and lactating women should use this drug with caution. Precautions for the elderly: Although there are slight pharmacokinetic differences between elderly female subjects and young women, this difference is mainly due to the physiological decline of renal function with age, and the dosage should be determined according to their renal function.

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 increased digoxin blood concentrations are found in some subjects. Therefore, patients taking digoxin should be monitored for symptoms and signs of digoxin toxicity. For patients showing toxic symptoms and signs, 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. 3. The simultaneous use of gatifloxacin and drugs that affect glucose metabolism can increase the risk of abnormal blood glucose metabolism in patients (see Contraindications and Warnings: Abnormal Blood Glucose). Antidiabetic drugs: Pharmacodynamic changes that affect glucose metabolism have been observed after the combined use of glibenclamide and other hypoglycemic drugs. No significant pharmacokinetic interactions were observed when glibenclamide was used in combination with gatifloxacin.

Keep in a dry place and sealed in a dark place. Valid for 24 months.

200 mg

24 months

Xiuzheng Pharmaceutical Group Co., Ltd.

• Founded in:

  1999-03-29

• Address:

  No. 36, Zhengxiu Road, Tonghua City, Jilin Province

• Tax NO.:

  91220501244585084W

• Registered Funds:

  50 million yuan

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