Gatifloxacin 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.

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

This product is a light yellow-green clear liquid.

It is 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. Acute sinusitis: caused by Streptococcus pneumoniae, Haemophilus influenzae, etc. Community-acquired pneumonia: caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Chlamydia pneumophila, Mycoplasma pneumophila, Legionella pneumophila, etc. Simple or complicated urinary tract infection (cystitis): caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, etc. Pyelonephritis: caused by Escherichia coli, etc. Simple urethral and cervical gonorrhea: caused by Neisseria gonorrhoeae. Acute simple straight

Intravenous drip, 0.2g each time (1 bottle), twice a day. This product is bioequivalent to oral tablets. During the treatment, the intravenous administration can be changed to oral tablets according to the doctor's decision without adjusting the dosage.

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, 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. 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. The incidence of laboratory abnormalities 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 for patients who are allergic to gatifloxacin and quinolones. It is contraindicated for patients with diabetes.

Precautions for children: The efficacy and safety of this product for children and adolescents (under 18 years old) have not been established, and it is recommended not to use this product. Precautions for pregnancy and lactation: The efficacy and safety of gatifloxacin for pregnant and lactating women have not been established. Pregnant women should avoid using this product, and lactating women should suspend breastfeeding when using it.

1. This product can be used in combination with probenecid to slow down the renal elimination of gatifloxacin. 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 dark, airtight, cool place (no higher than 20℃).

20ml:0.2g

Tentative 36 months

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• Founded in:

  1997-04-28

• Address:

  No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone

• Tax NO.:

  9132070070404786XB

• Registered Funds:

  6,379,002,274 yuan

• Website:

  Log in to view

• Email:

  Log in to view