GMP Certified / Cefoperazone Sodium and Tazobactam Sodium for Injection

• Quality Standard: USP, Bp
• Usage Mode: Injection
• Factory Certified: GMP
• Transport Package: Carton
• Specification: 1g
• Trademark: Sinolead
• Model NO.: injection
• Origin: China
• Production Capacity: 100000ctns Per Month

Product Description

Generic Name	Cefoperazone Sodium and Tazobactam Sodium for Injection
Strength	1g
Packing	10 vials /box
Origin	China

 

 

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Product name:
Cefoperazone Sodium and Tazobactam Sodium for Injection

Character:
This product is a compound preparation, each antibiotic bottle contains 1.6g cefoperazone sodium (cefoperazone) and 0.4g tazobactam sodium (tazobactam).

Indications:
For the treatment of moderate and severe infections caused by β-lactamase-producing bacteria that are resistant to cefoperazone and sensitive to this product. Additional antibiotics are not necessary for the treatment of mixed infections caused by cefoperazone sensitive bacteria and β-lactamase resistant bacteria sensitive to cefoperazone.
Lower respiratory tract infections: pneumonia, acute onset of chronic bronchitis, acute bronchitis, pulmonary abscess and other lung infections caused by sensitive bacteria such as Pseudomonas aeruginosa, Streptococcus pneumoniae and other Klebsiella genera, Haemophilus influenzae, Staphylococcus aureus, which produce β-lactamase.
Urinary and reproductive system infections: acute pyelonephritis, acute onset of chronic pyelonephritis, complex urinary tract infections, endometritis, gonorrhea and other reproductive tract infections caused by β-lactamase-producing Escherichia coli, Proteus, Klebsiella, Pseudomonas aeruginosa, Staphylococcus and other sensitive bacteria.
Abdominal and pelvic infections: peritonitis, cholecystitis, cholangitis and other abdominal infections and pelvic inflammation caused by Enterobacteria, Escherichia coli, Klebsiella, Pseudomonas aeruginosa, Citrobacter, Bacteroides peptostreptococcus and Clostridium.
Other infections: septicaemia caused by the above beta-lactamase-producing gram-positive and gram-negative bacteria, meningitis caused by diplococcus meningitidis and Haemophilus influenzae, severe skin and soft tissue infections.

Adverse reactions:
This product is generally well tolerated by patients, and most adverse reactions are mild and will disappear after discontinuation.
(1) Gastrointestinal tract: As with other beta-lactam antibiotics, the most common side effect of this product is gastrointestinal tract reaction. The most common are loose stools, diarrhea, followed by nausea and vomiting.
(2) Skin reaction: This product can cause allergic reactions, manifested as maculopapules, urticaria, eosinophilia and drug fever.
(3) Blood: Long-term use of this product can lead to reversible neutropenia, thrombocytopenia, prothrombin time extension, reduced prothrombin activity, can be seen in individual cases, bleeding phenomenon is rare, can be prevented and controlled by vitamin K.
(4) Laboratory anomalies: a few cases have glutamic oxalic aminotransferase, alanine aminotransferase, blood bilirubin transient increase.
(5) Other adverse reactions: occasional headache, chills and fever, pain at the infusion site and phlebitis.

Pharmacology and toxicology:
Pharmacological action
The antibacterial components of this compound are cefoperazone and tazobactam. Cefoperazone, a third-generation cephalosporin, has bactericidal effects by inhibiting the biosynthesis of sensitive bacterial cell walls. Tazobactam has no antibacterial activity against other bacteria except Neisseraceae and acinetobacter, but it irreversibly inhibits most important β-lactam enzymes produced by β-lactam antibiotic resistant strains. Tazobactam can prevent the destruction of penicillin and cephalosporin antibiotics by drug-resistant bacteria, and tazobactam has obvious synergistic effect with penicillin and cephalosporin antibiotics. Because tazobactam can bind to certain penicillin-binding proteins, sensitive strains may be more sensitive to this compound formulation than to cefoperazone alone.
Toxicological study
At present, there is no research data on genotoxicity, reproductive toxicity and carcinogenicity of this compound. For toxicological studies of each single drug, please refer to the following relevant data.
Genotoxicity:
Cefoperazone: In vivo and in vitro genotoxicity studies have not found that this product has mutagenic effect; The chromosome aberration test of human lymphocytes was negative, but chromosome breakage was found to increase during the whole blood cell culture of this product.
Tazobactam sodium: Tazobactam sodium at 333μg/ml blood concentration, the results of microbial mutation test were negative; When the concentration was 2000μg/ml, the results of DNA synthesis were negative. At 5000μg/ml, the HPRT point mutation test of Chinese hamster egg cells was negative. In the point mutation test with mouse lymphoma cells, tazobactam sodium was positive when ≥3000μg/ml; BALB/c-3T3 cell conversion test was negative at 900μg/ml. In vitro cytogenetic tests on Chinese hamster lung cells, Tazobactam sodium at 3000μg/ml was negative. There was no chromosomal aberration in rats given intravenous tazobactam sodium at a dose of up to 5000mg/kg (mg/m2 by body surface area, equivalent to 23 times the recommended daily maximum dose for humans).
Reproductive toxicity:
Cefoperazone: Subcutaneous injection of cefoperazone 1000mg/kg/ day (about 16 times the average adult dose) resulted in decreased testicular weight, inhibited spermatogenesis, decreased germ cell count and formation of cytoplasmic vacuoles in trophoblast cells in rats. In the dose range of 100-1000 mg/kg/ day, the severity of the damage is dose-dependent. Low doses caused a slight reduction in sperm cells, which was not observed in adult rats. This histological lesion was reversible in all but the highest dose groups. However, these tests did not evaluate later reproductive function in the rats. The relationship of these findings to humans has not yet been determined.
Tazobactam sodium: When the dose of tazobactam sodium is about 3 times the maximum recommended dose for humans (1.5g/ day) (by body surface area), there is no damage to the fertility of rats. Teratological studies have shown that tazobactam sodium given to mice and rats at 6 and 14 times the human dose (measured by body surface area) does not harm the fetus. Tazobactam sodium penetrates the rat placental barrier, and the concentration of tazobactam sodium in the fetus is about 10% or less of the maternal plasma concentration of the drug.

Storage:
Keep in a cool, dark and dry place.