Cefoperazone Sodium and Sulbactam Sodium for Injection

Pharmacological action: The antibacterial components of this compound are cefoperazone and sulbactam. Cefoperazone is a third-generation cephalosporin that achieves its bactericidal effect by inhibiting the biosynthesis of the cell wall of sensitive bacteria. Sulbactam has no antibacterial activity against other bacteria except Neisseriaceae and Acinetobacter. However, sulbactam has an irreversible inhibitory effect on most important β-lactamases produced by β-lactam antibiotic-resistant strains, thus protecting β-lactam antibiotics from hydrolytic destruction by β-lactamases of resistant bacteria. When the two are used in combination, they have 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 is effective against all bacteria that are sensitive to cefoperazone.

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 Incompatibility and Interactions Aminoglucoside

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, and most adverse reactions are mild to moderate, which can be tolerated and do not affect continued treatment. The following adverse reactions were observed from a comparative or non-comparative clinical trial database involving approximately 2,500 patients: Gastrointestinal reactions: Like other antibiotics, the most common adverse reactions when using this product are gastrointestinal reactions. It has been reported that diarrhea (loose stools) and abdominal pain are the most common, followed by nausea and vomiting with an incidence of 3.6-10.8%. Skin reactions: Like all penicillins and cephalosporins, this product can cause allergic reactions, manifested as maculopapular rash, urticaria, eosinophilia and drug fever. The incidence rate is 0.8-1.3%, which is prone to occur in patients with a history of allergies, especially to

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 the occurrence of a disulfiram-like reaction. 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 require nasogastric feeding or parenteral nutrition, alcohol should be avoided in fluid or infused nutrient solutions. 2 Aminoglycoside antibiotics cannot be used in the same

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

2.0g

24 months.

Hainan New Way Pharmaceufical Co., Ltd.

• Founded in:

  1994-07-29

• Address:

  No. 168, Nanhai Avenue, Haikou City, Haikou Free Trade Zone Yi Road

• Tax NO.:

  9146000029388198X2

• Registered Funds:

  33.1818 million yuan

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