Gatifloxacin 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. 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. Toxicological studies Genetic toxicity: This product has no mutagenic effect on multiple strains in the Ames test. However, it has a mutagenic effect on Salmonella strain TA102 in vitro. The results of gene mutation tests in Chinese hamster V79 cells and genetic tests in Chinese hamster CHL/IU cells were both positive. Similar results can also be seen in other quinolone drugs, which may be due to the inhibitory effect of this product on type II DNA topoisomerase in eukaryotes at high concentrations. The results of the mouse micronucleus test, rat oral cytogenetic test, and rat oral DNA repair test of this product were all negative. Reproductive toxicity: The oral dose of rats was up to 200 mg/kg (equivalent to the maximum recommended dose for humans based on daily systemic exposure [AUC]), and there was no adverse effect on rat fertility and reproduction. The oral doses of rats and rabbits reached 150 mg/kg and 50 mg/kg, respectively (based on AUC, approximately 0.7 and 1.9 times the maximum recommended dose for humans in clinical practice), and no teratogenic effect was observed. However, during the organogenesis period, oral or intravenous administration of 200 mg/kg and 60 mg/kg, respectively, can cause fetal skeletal malformations in rats; oral or intravenous administration of ≥150 mg/kg and ≥30 mg/kg, respectively, can cause delayed fetal skeletal ossification, including the appearance of wavy ribs. This suggests that at this dose, there is mild fetal toxicity. This toxicity can also be seen in other quinolones. Rats were given oral doses of 200 mg/kg in the initial stage of late pregnancy and continued to be administered until lactation. Increased post-implantation embryo loss and increased mortality in newborn rats and perinatal periods were observed. These findings also suggest the fetal toxicity of this product. Carcinogenicity: B6C3F1 mice were administered with the drug by mixing it with food for 18 months, with the doses of female and male animals being 90 mg/kg and 81 mg/kg respectively (based on AUC, it is approximately 0.13 and 0.18 times the maximum recommended dose for humans in clinical practice); Fischer344 rats were administered with the drug by mixing it with food for 2 years, with the doses of female and male animals being 139 mg/kg and 47 mg/kg respectively (based on AUC, it is 0.81 and 0.36 times the maximum recommended dose for humans in clinical practice). The results did not indicate that this product has the effect of promoting tumor growth. However, when the dose of male animals reached 100 mg/kg (based on AUC, it is approximately 0.74 times the maximum recommended dose for humans), the incidence of giant granulocyte lymphoblastic (1GL) leukemia was increased compared with the control group. Although this increase was slightly higher than the range of historical controls, it cannot be considered that these findings at high doses in male animals will affect the safety of this product in clinical use.

The main ingredient of this product is gatifloxacin, and its chemical name is: (plusmn;)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid hemihydrate.

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

Intravenous drip: 200 mg per time, twice a day for adults. The course of treatment is generally 3-14 days.

Adverse reactions seen in clinical trials are mostly mild, mainly seen in the intravenous administration site and the gastrointestinal tract and nervous system, including phlebitis, nausea, vomiting, diarrhea, headache and dizziness. Other rare clinically relevant 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, hyperlipidemia 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. Respiratory system: dyspnea, pharyngitis. Skin and skin soft tissue: rash, sweating, dry skin and itching. Special senses: visual abnormalities, taste abnormalities, tinnitus. Urogenital system; dysuria. Rare related adverse events include: abnormal thinking, alcohol intolerance, arthritis, weakness, asthma (bronchial spasm), ataxia, bone pain, bradycardia, chest pain, cheilitis, colitis, confusion, convulsions, cyanosis, depersonalization, depression, diabetes, dysphagia, ear pain, congestion, edema, epistaxis, euphoria, eye pain, photosensitivity, systemic water, rib bleeding, gingivitis, halitosis, hallucination, hematemesis, hematuria, hostility, hyperesthesia, hyperglycemia, increased muscle tension, hyperventilation, hypoglycemia, lymphadenopathy, papules, uterine bleeding, migraine, oral edema, myalgia, myasthenia, neck pain, panic, paranoia, parosmia, photophobia, pseudomembranous colitis, psychosis, ptosis, rectal bleeding, tension, substernal chest pain, tachycardia, loss of taste, tongue swelling, herpes, etc. The incidence of abnormal changes in laboratory tests is low, including: leukopenia, neutropenia, decreased hemoglobin, increased ALT and/or AST, as well as alkaline phosphatase, total bilirubin, blood sugar, serum amylase and electrolyte disorders.

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 should be monitored in patients taking digoxin. 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 tightly closed.

100ml: Gatifloxacin 0.2g and sodium chloride 0.9g

Foshan Haolang Pharmaceutical Co., Ltd.

• Founded in:

  1995-01-10

• Address:

  Hecun Development Zone, Lishui Town, Nanhai District, Foshan City

• Tax NO.:

  91440605280031572M

• Registered Funds:

  30 million yuan

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