Gatifloxacin Tablets

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 replication, transcription and repair process of bacterial DNA by inhibiting bacterial DNA gyrase and topoisomerase IV. The results of antibacterial experiments 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 Staphylococci, 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 is gatifloxacin, and its chemical name is: 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid racemate sesquihydrate. The molecular formula is: C19H22FN3O4times;1.5H2O, molecular weight: 40

This product is a light yellow tablet or film-coated tablet, which appears white to slightly yellowish after removing the coating.

This product is used to treat infections caused by the following sensitive strains: 1. Acute exacerbation of chronic bronchitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, and Staphylococcus aureus. 2. Acute sinusitis: caused by Streptococcus pneumoniae and Haemophilus influenzae. 3. Community-acquired pneumonia: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Chlamydia pneumophila, Mycoplasma pneumophila, and Legionella pneumophila. 4. Uncomplicated and complicated urinary tract infections (cystitis) caused by Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. 5. Pyelonephritis: caused by Escherichia coli. 6. Uncomplicated urinary tract infections in men: caused by Neisseria gonorrhoeae. 7. Uncomplicated cervical and rectal infections in women.

Oral administration, once daily, 200-400 mg, 2-4 tablets each time.

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 incidence include: Systemic reactions: allergic reactions, chills, fever, back pain and chest pain. Cardiovascular system: palpitations. Digestive system: diarrhea, constipation, indigestion, glossitis, candidal stomatitis, stomatitis, oral ulcers, vomiting. Metabolic and nutritional system: peripheral edema. Nervous system: dreaminess, insomnia, paresthesia, tremor, vasodilation, dizziness. Respiratory system: dyspnea, pharyngitis. Skin and skin soft tissue: rash, sweating. Special senses: abnormal vision, abnormal taste, tinnitus. Urogenital system: dysuria, hematuria. Other rare adverse events include: abnormal thinking, irritability, alcohol intolerance, loss of appetite, anxiety, arthralgia, arthritis, asthenia, asthma (bronchospasm), ataxia, bone pain, bradycardia, breast pain, cheilitis, colitis, confusion, convulsions, cyanosis, depersonalization, depression, diabetes, hypertension, dry skin, dysphagia, ear disease, ecchymosis, edema, epistaxis, euphoria, eye pain, facial edema, flatulence, gastritis, gastrointestinal bleeding, Gingivitis, halitosis, hallucination, hematemesis, hostility, hyperesthesia, hyperglycemia, hypertension, increased muscle tension, hyperventilation, hypoglycemia, leg cramps, lymphadenopathy, maculopapular rash, uterine bleeding, migraine, mouth edema, myalgia, muscle weakness, neck pain, nervousness, panic, paranoia, parosmia, pruritus, pseudomembranous colitis, psychosis, ptosis, rectal bleeding, drowsiness, tension, substernal chest pain, tachycardia, loss of taste, dry mouth, swollen tongue, herpes, etc. The incidence of abnormal changes in laboratory tests is low, including: leukopenia, thrombocytopenia, increased ALT or AST, and abnormal alkaline phosphatase, total bilirubin, serum amylase, electrolytes, etc.

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

Precautions for children: The efficacy and safety of this product for children and adolescents (under 18 years old) have not been established, and its use is not recommended at present. Precautions for pregnancy and lactation: The efficacy and safety of gatifloxacin for pregnant and lactating women have not been established. Pregnant and lactating women should use this product with caution. It can only be considered when the benefits of using this product outweigh the possible risks to the fetus and infant. Precautions for the elderly: Elderly patients are more likely to suffer from reduced renal function and may also be at greater risk of toxic reactions. Therefore, caution should be exercised when selecting the dosage, and monitoring renal function will be helpful. After gatifloxacin was launched, it has been reported that elderly patients treated with gatifloxacin had significant abnormal blood sugar. Elderly patients may have undetected diabetes, age-related reduced renal function, underlying diseases, and/or are taking concomitant medications that affect glucose metabolism, which may pose a special risk for abnormal blood sugar. When preparing to use gatifloxacin for patients, it is recommended that doctors discuss with patients who may be at risk of hypoglycemia and/or hyperglycemia (abnormal blood sugar metabolism events) so that patients know how to monitor their blood sugar changes and what measures should be taken when such changes occur.

1. This product can be used in combination with probenecid to alleviate the renal excretion of gatifloxacin. 2. When ferrous sulfate, aluminum or magnesium antacids and dehydroxyglycosides (didanoxine, Huituz) are used in combination with this product, the bioavailability of gatifloxacin is reduced. However, taking this product 4 hours before taking ferrous sulfate, dietary supplements containing zinc, magnesium, iron, etc. (such as multivitamins), or aluminum/magnesium antacids or dehydroxyglycosides (didanoxine, Huituz) does not affect the pharmacokinetic process of gatifloxacin. 3. No interaction was observed when milk, calcium carbonate, cimetidine, theophylline, warfarin, glyburide or midazolam were taken at the same time with this product. 4. When this product was used simultaneously with digoxin, no significant changes in the pharmacokinetic parameters of gatifloxacin were observed, but the blood concentration of digoxin was found to be increased in some subjects. Therefore, the symptoms and signs of digoxin toxicity should be monitored in patients taking digoxin. For patients who exhibit signs and symptoms of toxicity, digoxin plasma concentrations should be measured and the digoxin dose adjusted appropriately.

Store at 15-30℃, do not freeze. Valid for 2 years.

0.4g (calculated as C19H22FN3O4)

36 months

Hainan Hailing Chemipharma Corporation Ltd.

• Founded in:

  2004-04-01

• Address:

  No. 281 Nanhai Avenue, Haikou City

• Tax NO.:

  91460000760353116G

• Registered Funds:

  116.669422 million yuan

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