Cefoperazone Sodium and Sulbactam Sodium for Injection

This product has good antibacterial effect on Escherichia coli, Klebsiella, Proteus, Salmonella typhi, Shigella, Citrobacter and other Enterobacteriaceae and Pseudomonas aeruginosa. Haemophilus influenzae, Neisseria gonorrhoeae and Neisseria meningitidis are highly sensitive to this product. This product also has a good effect on all groups of streptococci and pneumococci, and has only a moderate effect on Staphylococcus aureus (methicillin-sensitive strains). Cefoperazone has a good effect on most Gram-positive anaerobes and some Gram-negative anaerobes. Cefoperazone mainly inhibits the synthesis of bacterial cell walls. Sulbactam itself has a weak antibacterial effect and is a competitive, irreversible beta-lactamase inhibitor. When used in combination with cefoperazone, it can increase the ability of cefoperazone to resist degradation by multiple beta-lactamases, and produce a significant synergistic effect on cefoperazone.

This product is a compound preparation, its components are 0.5g each of cefoperazone sodium and sulbactam sodium.

Cefpirome is available as a powder for reconstitution, in small vials for intravenous injection and in larger vials for intravenous infusion.

Used for respiratory tract infections, urinary tract infections, peritonitis, cholecystitis, cholangitis and other intra-abdominal infections, sepsis, meningitis, skin and soft tissue infections, bone and joint infections, pelvic inflammatory disease, endometritis, gonorrhea and other reproductive system infections caused by sensitive bacteria.

Intravenous drip. First dissolve an appropriate amount of 5% glucose injection or sodium chloride injection, and then dilute with the same solvent to 50-100 ml for intravenous drip, the drip time is 30-60 minutes. 1 Adults: The usual dose is 2-4g per day, which can be increased to 8g per day for severe or refractory infections. Divide into equal amounts and drip intravenously once every 12 hours. The maximum daily dose of sulbactam does not exceed 4g. 2 Children: The usual dose is 40-80mg/kg per day, divided into 2-4 drips. Severe or refractory infections can be increased to 160mg/kg per day. Divide into 2-4 drips. In the first week after birth, the newborn should be given once every 12 hours. The maximum daily dose of sulbactam does not exceed 80mg/kg.

1 Mainly gastrointestinal reactions, such as loose stools or mild diarrhea, nausea, vomiting, etc. 2 Allergic reactions: maculopapular rash, urticaria, eosinophilia, drug fever. These allergic reactions are prone to occur in patients with a history of allergies, especially those allergic to penicillin. 3 Blood system: neutropenia, decreased hemoglobin, thrombocytopenia, hypoprothrombinemia, eosinophilia, etc. 4 Laboratory tests: increased alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and blood bilirubin, increased urea nitrogen or creatinine, mostly transient. 5 Other reactions: headache, fever, chills, pain at the injection site, phlebitis, dyscolexy, etc.

Patients who are allergic to this product or cephalosporins are contraindicated.

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. Combined use with aminoglycoside antibiotics (gentamicin and tobramycin) has a synergistic effect on certain sensitive strains of Enterobacteriaceae and Pseudomonas aeruginosa. However, there are physical incompatibility taboos between this product and aminoglycoside antibiotics, so the two liquids cannot be directly mixed. If combined use is required, the two drugs can be injected intravenously in sequence. Different intravenous infusion tubes should be used for injection, or the previously used intravenous infusion tube should be fully flushed with another approved diluent during the injection interval. In addition, the interval between the administration of the two drugs should be extended as much as possible. 2. When used simultaneously with the following drugs, bleeding may occur: anticoagulant heparin, coumarin or indandione derivatives, thrombolytic drugs, non-steroidal anti-inflammatory analgesics (especially aspirin, diflunisal or other salicylic acid preparations) and sulfinpyrazone, etc. 3. This product is incompatible with compound sodium lactate injection or lidocaine hydrochloride injection. Therefore, the use of this solution during initial dissolution should be avoided, but a two-step dilution method can be used. That is, it is first dissolved with sterile water for injection, and then further diluted with compound sodium lactate injection or lidocaine hydrochloride injection to obtain a mixed solution that can be compatible with each other. 4 It is also incompatible with the following drug injections: doxycycline, meclofenoxate, amarin (Bianmailing), hydroxyzine hydrochloride (Antai Le), procainamide, aminophylline, prochlorperazine, cytochrome C, pentazocine (Zhentongxin), aprotinin, etc.

Finished product Store the finished product (sterile powder) in the dark at a temperature below 25°C. The color may darken during storage, but if the recommended storage conditions are followed, it will not have an adverse effect on the potency and safety of the drug. Reconstituted solution To maintain good efficacy, it is best to use freshly prepared drugs. This drug can be refrigerated (2-8°C) for up to 24 hours after being reconstituted with water for injection. This drug is miscible with several other commonly used intravenous injection solutions. It can be stored in the following liquids and refrigerated (2-8°C) for 24 hours: water for injection; 0.9% sodium chloride injection; 5% glucose solution; 10% glucose solution; 5% fructose solution; Ringer's solution. The reconstituted solution may darken during storage, but if the recommended storage conditions are followed, it will not have an adverse effect on the potency and safety of the drug. There is no data to support the use of reconstituted solution of this drug mixed with any drug or infusion solution other than specific drugs.

1 gram (C25H27N908S20.5 grams and C8H11N05S0.5 grams)

24 months.

Shanghai SPH New ASIA Pharmaceutical Co., Ltd.

• Founded in:

  1993-08-11

• Address:

  No. 978 Chuansha Road, Pudong New Area, Shanghai

• Tax NO.:

  91310115133738906M

• Registered Funds:

  1,052,429,132 yuan

• Website:

  Log in to view

• Email:

  Log in to view