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.

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.

Adverse events are usually collected from reports during clinical trials and after the product is marketed. Many events may be caused by factors other than medication, such as latent diseases. Since it is impossible to determine a specific causal relationship in most cases (even many adverse events are not adverse drug reactions), all adverse events collected are reported here even if it is not certain whether they are caused by this product. This product is generally well tolerated, and most adverse reactions are mild or 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 with approximately 2,500 patients: 1. Gastrointestinal reactions: Like other antibiotics, the most common side effect of this product is gastrointestinal reactions. It has been reported that diarrhea/loose stools are the most common (3.9%), followed by nausea and vomiting (0.6%). 2. Skin reactions: It has been reported that, like all penicillins and cephalosporins, allergic reactions manifest as maculopapular rash (0.6%) and urticaria (0.08%). These allergic reactions are prone to occur in patients with a history of allergies, especially those allergic to penicillin. 3. Hematological system: Some patients have been reported to have a slight decrease in neutrophils (0.4%, 5/1131). Like other beta-lactam antibiotics, long-term use of this product may cause reversible neutropenia (0.5%, 9/1696). During treatment, some patients may have a positive direct Coombs test reaction (5.5%, 15/269). As reported in the literature about other cephalosporins, this product can reduce hemoglobin (0.9%, 13/1416) and hematocrit (0.9%, 13/1409). Transient eosinophilia (3.5%, 40/1130) and thrombocytopenia (0.8%, 11/1414) have occurred. There have been reports of hypoprothrombinemia (3.8%, 10/262). 4. Others: headache (0.04%), fever (0.5%), pain at the injection site (0.08%) and chills (0.04%). Laboratory abnormalities: Transient elevation of liver function was found, serum aspartate aminotransferase (SGOT) was 5.7% (94/1638), serum pyruvate aminotransferase (SGPT) was 6.2% (95/1529), alkaline phosphatase was 2.4% (37/1518), bilirubin was 1.2% (12/1040). Local reactions: This product is well tolerated for intramuscular injection, and transient pain at the injection site may occur occasionally after injection. Like other penicillins and cephalosporins, phlebitis (0.1%) may occur at the injection site in some patients when this product is injected through an intravenous cannula. It has been reported that the following adverse reactions have occurred after this product was marketed: general adverse reactions: allergic reactions (including shock), cardiovascular system: hypotension, gastrointestinal tract: pseudomembranous colitis, hematopoietic system: lymphocytopenia, skin/appendages: pruritus, Stevens-Johnson syndrome, urinary system: hematuria, vascular system: vasculitis.

This product is contraindicated in patients who are allergic to cephalosporins or have a history of anaphylactic shock or immediate reaction to penicillin.

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.

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, patients should be particularly careful when drinking alcoholic beverages while using cefoperazone/sulbactam. When patients require enteral or parenteral nutrition, liquids containing alcohol should be avoided. Drug interactions in laboratory tests False positive reactions may occur when using Bennedict solution or Fehling reagent to test urine sugar.

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

3.0g (C25H27N9O8S22.0g and C8H11NO5S1.0g)

24 months.

Honz Pharmaceutical Co., Ltd.

• Founded in:

  1994-01-20

• Address:

  No. 6, Yaogu 3rd Road, Yaogu Industrial Park, Haikou National High-tech Industrial Development Zone, Hainan Province

• Tax NO.:

  91460000708873536T

• Registered Funds:

  455.124411 yuan

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