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 β-lactamase inhibitor. When used in combination with cefoperazone, it can increase the ability of cefoperazone to resist degradation by multiple β-lactamases, and produce a significant synergistic effect on cefoperazone.

This product is a sterile powder uniformly mixed with cefoperazone sodium and sulbactam sodium (1:1).

This product is white or off-white powder.

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, bacterial colony imbalance, 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. When used in combination with aminoglycoside antibiotics (gentamicin and tobramycin), it has a synergistic effect on certain sensitive strains of Enterobacteriaceae and Pseudomonas aeruginosa. However, there are physical incompatibility 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 the 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 contraindicated with the following drug injections: doxycycline, meclofenoxate, amarin (Bianmailing), hydroxyzine hydrochloride (Antai Le), procainamide, aminophylline, prochlorperazine, cytochrome C, pentazocine (Zhentongxin), aprotinin, etc.

Keep tightly closed in a cool, dark and dry place.

1.5g (C25H27N9O8S21.0g and C8H11NO5S0.5g)

24 months.

Shandong Runze Pharmaceuticals Co., Ltd.

• Founded in:

  2009-04-30

• Address:

  No. 999, University Road, High-tech Zone, Heze City, Shandong Province

• Tax NO.:

  91371700688283183B

• Registered Funds:

  277 million yuan

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