Pazufloxacin Mesylate Sodium Chloride Injection

This product belongs to the quinolone antibacterial drug. Its main mechanism of action is to inhibit the activity of DNA gyrase and DNA topoisomerase IV of Staphylococcus aureus, hinder DNA synthesis and cause bacterial death; it has a weak inhibitory effect on human topoisomerase II. This product has the characteristics of a broad antibacterial spectrum and strong antibacterial effect. It has good antibacterial activity against G bacteria such as Staphylococcus, Streptococcus, Enterococcus, and G- bacteria such as Escherichia coli, Bacillus mirabilis, Klebsiella, Enterobacter cloacae, Citrobacter rodentium, Acinetobacter calcoaceticus, Haemophilus influenzae, Bacillus catarrhalis, Pseudomonas aeruginosa, etc. This product also has good antibacterial activity against some anaerobic bacteria such as Clostridium perfringens, Fusobacterium nucleatum, Propionibacterium acnes, Porphyromonas, some Peptostreptococci, Bacteroides fragilis and Prevotella. Toxicology study on repeated dose toxicity: rats were intravenously injected with 4, 13, 39, and 130 mg/kg/day for 3 consecutive months. The A/G (albumin/globulin) ratio of rats in the 130 mg/kg group increased, and cavitation of articular cartilage was observed in a few rats. However, no abnormal reactions caused by the drug were observed in monkeys after intravenous injection of 26, 52 and 104 mg/kg/day for 13 consecutive weeks.

The main ingredient of this product is pazufloxacin mesylate, its chemical name: (-)-(3S)-10-(1-aminocyclopropyl)-9-fluoro-2,3-dihydro-3-methyl-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid methanesulfonate. Molecular formula: C16H15FN2O4·CH4O3S, molecular weight: 414.41.

This product is a white to light yellow clear solution.

This product is effective for the following moderate and severe infections caused by sensitive bacteria among Staphylococcus, Streptococcus, Enterococcus, Neisseria, Haemophilus, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Morganella, Providencia, Haemophilus influenzae, Pseudomonas aeruginosa, Acinetobacter, and Bacteroides: 1. Respiratory system infections: acute bronchitis, acute infection of chronic bronchitis, purulent tonsillitis, peritonsillar abscess, pneumonia, lung abscess, chronic respiratory diseases with infection, etc.; 2. Urinary system infections: acute urethritis, acute cystitis, acute pyelonephritis, acute attack of chronic pyelonephritis, complicated urinary tract infection, acute bacterial prostatitis, etc.; 3. Gynecological infections: adnexitis, uterine adnexitis, uterine ulcer, etc.

Usage: intravenous drip. Dosage: 0.3g once, twice a day, intravenous drip time is 30 to 60 minutes, and the course of treatment is 7 to 14 days. The dosage can be adjusted according to the patient's age and condition.

The main clinical adverse reactions of this product are diarrhea, rash, nausea, and vomiting. Laboratory tests show elevated ALT, AST, ALP, r-GTP, and increased eosinophils. 1 Clinical adverse reactions: 1) Acute renal failure: may cause acute renal failure. 2) Abnormal liver function, jaundice. 3) Pseudomembranous colitis: severe enteritis with bloody stools may occur. If abdominal pain or frequent diarrhea occurs, the drug should be discontinued immediately and appropriate preventive measures should be taken. 4) Granulocytopenia, thrombocytopenia. 5) Rhabdomyolysis: If myalgia, weakness, elevated creatine phosphokinase (CPK), or elevated myosin in blood or urine occurs, the drug should be discontinued immediately. Rhabdomyolysis can also lead to acute renal failure. 6) Spasm. 7) Shock, allergic reaction. If any abnormalities such as dyspnea, edema, erythema, etc. occur, the drug should be discontinued and appropriate treatment measures should be taken. 8) Epidermal exfoliation necrosis (Lyell syndrome), eye, mucous membrane, skin syndrome (Stevens Johnson syndrome). 9) Interstitial pneumonia: pneumonia with fever, cough, dyspnea, and abnormal chest X-ray. 10) Hypoglycemia: Severe hypoglycemia is prone to occur in elderly patients and patients with renal failure, and should be carefully observed. 11) Achilles tendonitis and tendon rupture. Close observation should be made during administration. If the above adverse reactions occur, the drug should be discontinued immediately and appropriate treatment measures should be taken. 2 Adverse reactions of similar drugs: PIE syndrome: PIE syndrome accompanied by fever, cough, dyspnea, abnormal chest X-ray, and eosinophilia has been reported in other new quinolone drugs used in clinical practice. If the above adverse reactions occur, the drug should be discontinued immediately and appropriate treatment measures should be taken. 3 Other adverse reactions: Take appropriate treatment measures if the following adverse reactions are observed: 1) Allergic reactions: rash, fever (incidence 0.1-5%), urticaria, itching, facial skin flushing (incidence 0.1%). 2) Kidney damage: increased BUN, proteinuria, bilirubinuria, tubular urine, urinary occult blood (incidence 0.1-5%), increased blood creatinine (incidence 0.1%). 3) Liver damage: increased ALT (GPT) (incidence ≥5%), increased AST (GOT), ALT, r-GTP, LAP, LDH and bilirubin (incidence 0.1-5%). 4) Blood: eosinophilia, leukopenia, thrombocytopenia, anemia (incidence 0.1-5%). 5) Gastrointestinal reactions: diarrhea or soft stools, nausea, vomiting (incidence 0.1-5%), upper abdominal discomfort, abdominal distension, black stools (incidence 0.1%). 6) Mental and nervous system: headache, dizziness (incidence 0.1-5%), transient impaired consciousness, transient mental disorder, mental abnormality (incidence 0.1%). 7) Others: phlebitis (incidence ≥5%), increased CK (CPK), electrolyte imbalance (incidence 0.1-5%), dry mouth, glossitis (incidence 0.1%).

Patients with a history of allergy to pazufloxacin and quinolones are contraindicated.

Precautions for children: The safety of the drug for children has not been established, and it is recommended that children should not use this product. Precautions for pregnancy and lactation: Pregnant women and women who may become pregnant should not use this product; because the drug can be secreted through breast milk, lactating women should stop breastfeeding when using this product.

1. This product can inhibit the metabolism of theophylline in the liver, increase the blood concentration of theophylline, and may cause symptoms of theophylline poisoning, such as gastrointestinal reactions, headaches, arrhythmias, spasms, etc., so patients need to be closely observed, and the blood concentration of theophylline should be closely observed when the two drugs are used together. 2. This product may cause spasms when used in combination with phenylacetic acid, diacetyl ketoacid, and non-steroidal anti-inflammatory analgesics, so it should be closely observed. If symptoms occur, the drug should be discontinued immediately and antispasmodic treatment should be taken. When spasms occur, the combination of the two drugs should be terminated, the respiratory tract should be kept unobstructed, and antispasmodic drugs should be used for treatment. 3. When this product is used in combination with warfarin, it can enhance the effect of warfarin, thereby prolonging the coagulation time, so it should be closely observed and a coagulation time test should be performed when using the drug. 4. When this product is used in combination with probenecid, the serum half-life is prolonged and the AUC increases, but there is no significant change in the peak blood concentration.

Keep away from light, sealed and stored in a dry place.

100ml: 0.3g of pazufloxacin mesylate (calculated as pazufloxacin) and 0.9g of sodium chloride

24 months

NORTHEAST Pharmaceutical Group Shenyang NO.1 Pharmaceutical Co., Ltd.

• Founded in:

  1989-01-25

• Address:

  No. 8 Kunming Lake Street, Shenyang Economic and Technological Development Zone

• Tax NO.:

  91210106242656694M

• Registered Funds:

  80 million yuan

• Website:

  Log in to view

• Email:

  Log in to view