Pazufloxacin Mesylate for Injection

Pharmacological action: This product belongs to the quinolone antibacterial drug, and its main mechanism of action is to inhibit the activity of DNA gyrase and DNA topoisomerase IV of Staphylococcus aureus, hinder DNA synthesis and lead to bacterial death; it has weak inhibitory effect on human topoisomerase II. This product has the characteristics of 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, 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.

Active ingredient: Pazufloxacin mesylate

This product is off-white to light yellow loose lumps and powder, odorless and bitter.

The 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, cholebrachiitis, liver abscess; (5) intra-abdominal abscess, peritonitis; (6) infections of reproductive organs, such as adnexitis, endometritis and pelvic inflammatory disease.

Usage: intravenous drip. Dosage: 0.3g once, twice a day, intravenous drip time is 30-60 minutes, and the course of treatment is 7-14 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 abnormality such as dyspnea, edema, erythema, etc. occurs, 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 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 with 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 ge; 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 ge; 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.

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 open, 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 is increased, but there is no significant change in the peak blood concentration.

Keep away from light, tightly closed, in a cool place.

0.3g (calculated as pazufloxacin)

Hebei Zhitong Biopharmaceutical Co., Ltd.

• Founded in:

  1998-08-06

• Address:

  No.1 Gucheng, Dingxing County, Hebei Province

• Tax NO.:

  91130600108345190C

• Registered Funds:

  127.5 million yuan

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