Cefoperazone Sodium and Sulbactam Sodium for Injection

The antibacterial components of this compound are cefoperazone and sulbactam. Cefoperazone is a third-generation cephalosporin that achieves bactericidal effects by inhibiting the biosynthesis of sensitive bacterial cell walls. Sulbactam has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter, but sulbactam has an irreversible inhibitory effect on most important β-lactamases produced by β-lactam antibiotic-resistant strains, thus protecting β-lactam antibiotics from hydrolysis and destruction by β-lactamases of resistant bacteria. When the two are used together, there is a significant synergistic effect. Because sulbactam can bind to certain penicillin-binding proteins, sensitive strains are usually more sensitive to this compound preparation than when cefoperazone is used alone. This compound preparation has antibacterial activity against all bacteria that are sensitive to cefoperazone. It is mainly active against the following microorganisms in vitro. Gram-positive aerobic bacteria: Staphylococcus aureus (penicillinase-producing and non-producing strains), Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes (group A-hemolytic streptococci), Streptococcus agalactiae (group B-hemolytic streptococci), most hemolytic streptococci, Enterococci (Streptococcus faecalis, Streptococcus parahaemolyticus, Streptococcus perseverant). Gram-negative aerobic bacteria: Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Citrobacter spp., Haemophilus influenzae, Proteus mirabilis, Proteus vulgaris, Morganella, Providencia rettgeri, Serratia spp. (including Serratia marcescens), Salmonella and Shigella spp., Pseudomonas aeruginosa and certain other Pseudomonas spp., Acinetobacter calcoaceticus, Neisseria meningitidis, Bordetella pertussis, Yersinia enterocolitica. Anaerobic microorganisms: Gram-negative rods (including Bacteroides fragilis, other Bacteroides and Fusobacterium), Gram-positive and Gram-negative cocci (including Peptococcus, Peptostreptococcus and Veillonella), Gram-positive rods (including Clostridium, Eubacterium and Lactobacillus).

This product is a compound preparation, and its components are: each vial contains 0.5g of cefoperazone sodium calculated as cefoperazone and 0.5g of sulbactam sodium calculated as sulbactam.

This product is white or off-white powder.

This product is suitable for the treatment of the following infections caused by sensitive bacteria: 1) upper and lower respiratory tract infections; 2) upper and lower urinary tract infections; 3) peritonitis, cholecystitis, cholangitis and other intra-abdominal infections; 4) sepsis; 5) meningitis; 6) skin and soft tissue infections; 7) bone and joint infections; 8) pelvic inflammatory disease, endometritis, gonorrhea and other reproductive system infections. Since cefoperazone/sulbactam has a broad spectrum of antibacterial activity, this product alone can treat most infections, but sometimes cefoperazone/sulbactam needs to be used in combination with other antibiotics. When this product is used in combination with aminoglycoside antibiotics (see the section on incompatibility and interactions of aminoglycoside antibiotics), the patient's renal function should be monitored during treatment (see the section on medication for patients with renal dysfunction in the section on dosage and administration).

1 Adult use: The recommended daily dose of cefoperazone/sulbactam for adults (ratio 1:1) is as follows: Cefoperazone/sulbactam (g) 2.0-4.0 Cefoperazone (g) 1.0-2.0 Sulbactam (g) 1.0-2.0 The above doses are divided into equal parts and administered once every 12 hours. In severe or refractory infections, the daily dose of cefoperazone/sulbactam can be increased to 8 grams (1:1 cefoperazone/sulbactam, i.e. 4 grams of cefoperazone and 4 grams of sulbactam each). If necessary, patients receiving 1:1 cefoperazone/sulbactam treatment can increase the dose of cefoperazone separately. The dose should be divided into equal parts and administered once every 12 hours. The recommended maximum daily dose of sulbactam is

1. Generally speaking, patients tolerate this product well. Most adverse reactions are mild to moderate, can be tolerated, and do not affect continued treatment. The following adverse reactions were observed from a comparative or non-comparative clinical trial database with about 2,500 patients: Gastrointestinal reactions: Like other antibiotics, the most common side effect when using this product is gastrointestinal reactions. According to reports, diarrhea (loose stools) and abdominal pain are the most common, followed by nausea and vomiting, with an incidence of 3.6% to 10.8%. Skin reactions: Like all penicillins and cephalosporins, this product can cause allergic reactions, manifested as maculopapular rash, urticaria, eosinophilia and drug fever. The incidence is 0.8% to 1.3%, which is prone to occur in patients with a history of allergies, especially those with a mild decrease in neutrophils who are allergic to penicillin. Blood system: Like other β-lactam antibiotics, long-term use of this product may lead to reversible neutropenia. Some patients have a positive reaction to the direct Coombs test. A decrease in hemoglobin and hematocrit has been reported. Transient eosinophilia and thrombocytopenia have been found. Hypoprothrombinemia has also been reported. Other adverse reactions: Headache, fever, pain at the injection site, chills, etc. occur in less than 1% of patients. Those who drink alcohol or take alcoholic drugs during the use of this product may experience a disulfiram-like reaction (disulfirm reaction). Laboratory abnormalities: In 6.3% to 10% of the reported cases, there was a transient increase in aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or blood bilirubin, increased urea nitrogen and creatinine, dysbacteriosis, etc. Local reactions: When injected intramuscularly, this product is well tolerated, with occasional transient pain at the injection site. Like other cephalosporins and penicillins, some patients will develop phlebitis at the infusion site when infused with an intravenous cannula. 2. It has been reported that the following adverse reactions have also occurred after this product was marketed: (1) General adverse reactions: allergic reactions (including shock), etc. (2) Cardiovascular system: hypotension, etc. (3) Gastrointestinal tract: pseudomembranous colitis, etc. (4) Hematopoietic system: lymphocytopenia, etc. (5) Skin/appendages: pruritus, Stevens-Johnson syndrome, etc. (6) Urinary system: hematuria, etc. (7) Vascular system: vasculitis.

It is contraindicated for patients who are allergic to penicillins, sulbactam, cefoperazone and other cephalosporin antibiotics.

Precautions for children: This product has been effectively used to treat infections in infants. However, extensive studies have not been conducted on premature infants and newborns, so this product must be used with caution after weighing the pros and cons before use in newborns and premature infants. Precautions for pregnancy and lactation: Animal experiments have not found that this product harms reproductive capacity and the fetus, but there is still a lack of sufficient controlled research data in humans. Therefore, pregnant women should use this product with caution and only use this product when it is clearly indicated. Cefoperazone and sulbactam can be secreted into breast milk in small amounts, so lactating women should use it with caution. Precautions for the elderly: The elderly have physiological liver and kidney function impairment, so this product should be used with caution and the dosage needs to be adjusted.

1. Drinking alcohol or intravenous injection of ethanol-containing drugs will inhibit the activity of acetaldehyde deoxygenase, causing acetaldehyde accumulation in the blood and disulfiram-like reactions. It has been reported that drinking alcohol during the use of cefoperazone and within 5 days after stopping the drug can cause characteristic reactions such as facial flushing, sweating, headache and tachycardia. Similar reactions have also been reported for some other cephalosporins. Therefore, when patients use this product, they should avoid using alcohol-containing drugs and drinking alcohol to avoid disulfiram-like reactions. For patients who need nasogastric feeding or parenteral nutrition, alcohol should be avoided in the fluid or infusion of nutrient solution. 2. Aminoglycoside antibiotics cannot be used in the same container because there are physical incompatibility taboos between cefoperazone/sulbactam and aminoglycoside antibiotics, and the antibacterial activity of direct mixing decreases. If cefoperazone/sulbactam and aminoglycoside antibiotics are really needed, sequential intermittent intravenous infusion can be used for administration, but different intravenous infusion tubes must be used, or the previously used intravenous infusion tube must be fully flushed with an appropriate diluent during the infusion interval. In addition, it is recommended that the interval between the administration of cefoperazone/sulbactam and aminoglycoside antibiotics should be as long as possible during the whole day's medication. 3. Lidocaine Since this product is incompatible with 2% lidocaine hydrochloride injection, this solution should be avoided during the initial dissolution. In the two-step dilution method, the initial dissolution is first performed with injection water, and then further diluted with 2% lidocaine hydrochloride injection to obtain a mixed solution that can be compatible with each other. 4. When this product is used in combination with drugs that cause bleeding tendency such as anticoagulants, thrombolytics, non-steroidal anti-inflammatory drugs, etc., the cumulative or multiple effects on human coagulation function and bleeding risk should be considered. 5. This product cannot be mixed with amikacin, gentamicin, kanamycin B, doxycycline, chlorpromazine, amarin, diphenhydramine, potassium magnesium aspartate to avoid precipitation. This product changes in appearance 6 hours after mixing with Antalol, procainamide, aminophylline, prochlorperazine, cytochrome C, analgesic, and aprotinin. This product precipitates when combined with acid preparations, amine-containing, and amine-base preparations, and reduces its potency when combined with alkali preparations. 6. Drug laboratory test interactions: Using Benedict or Fehling's solution to check for glucose in urine may result in a false reaction. The direct antiglobulin test is positive. If this product is used by pregnant women before delivery, this test may also be positive for newborns. Occasionally, alkaline phosphatase, serum alanine aminotransferase, serum aspartate aminotransferase, serum creatinine, and blood urea nitrogen increase.

Sealed, stored in a cool, dark and dry place. Validity period: 24 months

2.0g(C25H27N9O8S21.0g and C8H11NO5S1.0g)

24 months.

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• Founded in:

  1997-04-28

• Address:

  No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone

• Tax NO.:

  9132070070404786XB

• Registered Funds:

  6,379,002,274 yuan

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