Pazufloxacin Mesylate for Injection

1. This product is a new type of fluoroquinolone antibacterial drug. Its main mechanism of action is to inhibit the activity of bacterial DNA helicase enzyme topoisomerase IV and hinder the replication of bacterial DNA to achieve antibacterial effect. 2. Pazufloxacin is effective against aerobic bacteria, general anaerobic bacteria, and anaerobic Gram-positive bacteria and Gram-negative bacteria. It has the same antibacterial effect as imipenem and ciprofloxacin, and its antibacterial spectrum is the same as ceftazidime and gentamicin. It has strong antibacterial activity against clinically isolated Staphylococcus, Enterobacter, Pseudomonas aeruginosa, various Gram-negative bacteria, Pseudomonas and Prevotella bacteria. This product has strong antibacterial activity against resistant bacteria to imipenem, cefazolin, ceftazidime, intestinal bacterial flora, ampicillin-resistant bacteria - Haemophilus influenzae, resistant bacteria produced by imipenem, gentamicin, Pseudomonas aeruginosa when used alone or in combination with ceftazidime, and β-lactamase hydrolysis of imipenem to produce resistant bacteria - Serratia marcescens. 3. Antibacterial effect This product has a killing effect on Pseudomonas aeruginosa, Escherichia coli, and Staphylococcus aureus. This product has a strong killing effect on Pseudomonas aeruginosa in the stationary phase, logarithmic growth phase, and stable phase, and the intensity of action is stronger than ceftazidime and gentamicin. The antibacterial effect of this product on Staphylococcus aureus in the stable phase is the same as that of ceftazidime and gentamicin, and the killing effect on Staphylococcus aureus in the stationary phase and growth phase is stronger than that of ceftazidime.

Active ingredient: Pazufloxacin mesylate

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, 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: Dissolve 0.3g of this product in 100ml 0.9% sodium chloride injection and drip intravenously. 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 increased ALT, AST, ALP, r-GTP, and increased eosinophils. (1) Clinical adverse reactions: 1) Acute renal failure: It may cause acute renal failure. 2) Abnormal liver function, jaundice. 3) Pseudomembranous colitis: Severe enteritis accompanied by 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), or increased 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 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.

Not yet clear

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

0.5g (calculated as pazufloxacin)

Nanjing Cuccess Pharmaceutical Co., Ltd.

• Founded in:

  2002-03-20

• Address:

  No. 20, Xingang Avenue, Nanjing Economic and Technological Development Zone

• Tax NO.:

  913201926089285606

• Registered Funds:

  60 million yuan

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