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Cefoperazone Sodium and Sulbactam Sodium for Injection

September 20,2022

Composition

This product is a compound preparation, and its components are as follows: (1)0.75g: a bottle of sterile powder containing cefoperazone sodiumand sulbactam sodium [0.5g of cefoperazone (C25H27N9O8S2) and 0.25g of sulbactam (C8H11NO5s)] uniformly mixed. (2)1.5g: each bottle contains sterile powder which is evenly mixed with cefoperazone sodium and sulbactam sodium [1.0g of cefoperazone (C25H27n9O8S2) and 0.5g of sulbactam (C8H11NO5s)]. (3)2.25g: each bottle contains sterile powder which is evenly mixed with cefoperazone sodium and sulbactam sodium [1.5g of cefoperazone (C25H27n9O8S2) and 0.75g of sulbactam (C8H11NO5s)]. (4)3.0g: each bottle contains sterile powder which is evenly mixed with cefoperazone sodium and sulbactam sodium [2.0g of cefoperazone (C25H27n9O8s2) and 1.0g of sulbactam (C8H11NO5s)].

Character

This product is white or white-like powder.

Indication
This product is used to treat the following infections caused by sensitive bacteria: respiratory tract infection (upper respiratory tract and lower respiratory tract); Urinary tract infection (upper urinary tract and lower urinary tract); Peritonitis, cholecystitis, cholangitis and other intra-abdominal infections; Sepsis, meningitis; And skin and soft tissue infection, eye infection, bone and joint infection; Pelvic inflammatory disease, endometritis, gonorrhea and other genital tract infections; Prevent postoperative infection caused by abdominal, gynecological, cardiovascular, orthopedic and plastic surgery.

As a generic drug supplier in China, Feiyue Pharmaceutical can provide finished drugs such as Injection of Cefoperazone Sodium and Sulbactam Sodium for Injection
Packaging: 10ml tubular vial with filp-off, 1’s/box, 10’s/box, 50’s/box
FEIYUE recruits agents worldwide, we can provide complete registration documents.

Adverse effect
Patients usually tolerate cefoperazone-sulbactam well. Most adverse reactions are mild or moderate, which can be tolerated and will not affect the continued treatment. 1. The common adverse reactions are diarrhea, diarrhea, transient increase of stool, ALT, AST, ALP and blood bilirubin; 2. Less common adverse reactions (

Taboo

Those allergic to penicillin or cephalosporin antibiotics are prohibited.

Drug interaction
This product has synergistic effect with aminoglycoside antibiotics, but they are incompatible. If they need to be used together, they should be dissolved and diluted separately and then infused.

Pharmacology
Cefoperazone can kill bacteria by inhibiting the cell wall synthesis of bacteria. Sulbactam not only has antibacterial activity against Neisseria gonorrhoeae and Acinetobacter, but also acts as an irreversible inhibitor against β -lactamase produced by drug-resistant strains. Therefore, the two components of this product have obvious synergistic antibacterial effect on various drug-resistant bacteria, and are harmful to various common pathogenic bacteria. Such as: Haemophilus influenzae, Escherichia coli, Staphylococcus, Aeromonas, Proteus mirabilis, Klebsiella, Morganella, Acinetobacter calcoaceticus, Enterobacter, Citric acid-producing bacteria, etc. have extremely significant synergistic effect (MIC value can be reduced by more than four times compared with cefoperazone alone).

Dosage

1. Adult medication: the ratio is 1: 1, cefoperazone/sulbactam 2.0-4.0g, cefoperazone 1.0-2.0g and sulbactam 1.0-2.0g. The above doses are divided into equal amounts and administered every 12 hours. In the treatment of severe or refractory infections, the daily dose of cefoperazone/sulbactam can be increased to 8g (1: 1 cefoperazone/sulbactam, that is, 4g cefoperazone). When the condition requires, patients who receive 1: 1 cefoperazone/sulbactam treatment can separately increase the dosage of cefoperazone, and the dosage used should be divided into equal parts and administered every 12 hours. The recommended maximum daily dose of sulbactam is 4g.
2. Medication for patients with liver dysfunction: please refer to the “Precautions” section.
3. Medication for patients with renal dysfunction: The clearance of sulbactam in patients with significantly reduced renal function (creatinine clearance rate 4. Intravenous administration:
(1) When intermittent intravenous drip is used, each bottle of cefoperazone/sulbactam is dissolved with an appropriate amount of 5% glucose solution or 0.9% sodium chloride solution for injection or sterilized water for injection (see [Usage and Dosage] for the dissolution of this product), and then diluted to 20ml with the same solution mentioned above. The intravenous drip time should be at least 15-60 minutes. Although sodium lactate Ringer injection can be used as the solvent of cefoperazone/sulbactam intravenous injection, it can’t be used in the initial dissolution process of this product (see [Drug Interaction] incompatibility of sodium lactate Ringer injection and [Usage and Dosage] instructions for use/operation of sodium lactate Ringer injection).
(2) When intravenous injection is used, each bottle of cefoperazone/sulbactam should be dissolved according to the above method, and the intravenous injection time should be at least more than 3 minutes.
5. Intramuscular injection: Although 2% lidocaine hydrochloride injection can be used as the solvent of cefoperazone/sulbactam intramuscular injection, it can’t be used in the initial dissolution process of this product (see [Drug Interaction] incompatibility lidocaine section and [Usage and Dosage] usage/operation instructions lidocaine section).
6. Instructions for use/operation:
(1) Dissolution of this product: 1.0g cefoperazone/sulbactam is contained in each bottle of this product. Cefoperazone/sulbactam can be compatible with water for injection, 5% glucose injection, normal saline, 5% glucose and 0.225% sodium chloride injection, 5% glucose and 0.9% sodium chloride injection, etc. in the concentration range of cefoperazone and sulbactam respectively.
(2) Sodium lactate Ringer’s injection: cefoperazone/sulbactam should be dissolved with sterilized water for injection (see the incompatibility of sodium lactate Ringer’s injection in Drug Interaction). Two-step dilution method is adopted: firstly, it is dissolved with sterilized water for injection (as shown in the above table), and then diluted with sodium lactate Ringer’s injection to sulbactam solution with a concentration of 5mg/ml (diluted with 2ml initial solution to 50ml sodium lactate Ringer’s injection or 4ml initial solution to 100ml sodium lactate Ringer’s injection).
(3) Lidocaine: Cefoperazone/sulbactam should be dissolved with sterilized water for injection (see [Drug Interaction] Contraindications of Lidocaine Compatibility). Two-step dilution method should be adopted: firstly, it is dissolved with sterilized water for injection (as shown in the above table), and then diluted with 2% lidocaine solution, so that the concentrations of cefoperazone and sulbactam in about 0.5% lidocaine hydrochloride solution reach 125mg/ml and 125mg/ml respectively.