Pazufloxacin Mesylate Sodium Chloride Injection

This product belongs to the quinolone antibacterial drug. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase and DNA topoisomerase IV, while its inhibitory effect on human DNA topoisomerase II is weak. This product has the characteristics of a broad antibacterial spectrum and strong antibacterial activity. Its antibacterial activity against aerobic, facultative anaerobic and anaerobic Gram-positive and -negative bacteria is the same as that of imipenem and ciprofloxacin, and it has a wider antibacterial spectrum than ceftazidime and gentamicin sulfate. It has strong antibacterial activity against various Gram-positive bacteria including clinically isolated Staphylococcus, Enterococcus, Pseudomonas aeruginosa, Bacteroides fragilis and Prevotella. In addition, this product shows strong antibacterial activity against intestinal bacteria resistant to imipenem, cefazolin or ceftazidime, ampicillin-resistant Haemophilus influenzae, Pseudomonas aeruginosa resistant to single-dose imipenem and gentamicin or two or three-dose drugs with ceftazidime added, imipenem-degrading β-lactamase-producing Serratia marcescens and Pseudomonas aeruginosa. This product has a bactericidal effect on Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa, especially this product has a stronger bactericidal effect than ceftazidime and gentamicin in any period of the initial stationary period, logarithmic growth period, and stable period of Pseudomonas aeruginosa.

【Ingredients】Pazufloxacin mesylate. Chemical name: (-)-(S)-10-(1-aminocyclopropyl)-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid methanesulfonate. Chemical structure: Molecular formula: C16H15FN2O4·CH4O3S Molecular weight: 414.41

This product is suitable for the following infections caused by sensitive bacteria: 1. Secondary infections of chronic respiratory diseases, such as chronic bronchitis, diffuse bronchiolitis, bronchiectasis, emphysema, pulmonary interstitial fibrosis, bronchial asthma, old pulmonary tuberculosis, etc.; pneumonia, lung abscess; 2. Pyelonephritis, complicated cystitis, prostatitis; 3. Burn wound infection, surgical wound infection; 4. Cholecystitis, cholangitis, liver abscess; 5. Intra-abdominal abscess, peritonitis; 6. Reproductive organ infection, such as adnexitis, endometritis, pelvic inflammatory disease.

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 increased 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, increased creatine phosphokinase (CPK), and increased myosin in blood or urine occur, 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) 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 has occurred 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, occult blood in urine (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. Pregnant and lactating women are contraindicated. The safety of children's use has not been established, and it is recommended that children not use this product. Elderly patients should check the blood concentration and urine excretion results when using this product. When Cmax increases, AUC increases, and urine recovery rate decreases, pay attention to the dosage and use the drug with caution.

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, diethyl ketoacids, and non-steroidal anti-inflammatory analgesics, so it should be closely observed. If symptoms occur, the drug should be discontinued immediately and spasmolytic treatment should be taken. When spasms occur, the combination of the two drugs should be terminated. Keep breathing unobstructed and use spasm-relieving drugs 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 propanesulfonic acid, 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: 0.5g of pazufloxacin mesylate (calculated as C16H15FN2O4) and 0.9g of sodium chloride

Liaoning Hishen Liansheng Pharmaceutical Co., Ltd.

• Founded in:

  2001-02-27

• Address:

  No. 3, Jinquan Road, Langtou Town, Dandong City

• Tax NO.:

  912106007268406746

• Registered Funds:

  30 million yuan

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