Cefpiramide Sodium for Injection

1. Antibacterial effect 1) It has strong antibacterial activity against Gram-positive bacteria, and also has broad-spectrum antibacterial activity against bacteria including Gram-negative bacteria. At the same time, it has strong antibacterial activity against non-fermenting Gram-negative bacteria such as Pseudomonas aeruginosa. The drug has a bactericidal effect and is stable to β-lactamase produced by various bacteria. 2) When used for experimental infection (mice), it shows excellent therapeutic effect. 3) It is sensitive to bacteria resistant to penicillin, other cephalosporins or aminoglycoside antibiotics, especially Pseudomonas aeruginosa. 2. Mechanism of action It has a strong affinity with 1A, 1B and 3 of penicillin binding protein (PBP), inhibits the synthesis of bacterial cell wall, and thus exerts a bactericidal effect.

The main ingredient of this product is cefpiramide sodium, and its chemical name is: [6R-[6α,7β(R)]]-7-[[[[(4-hydroxy-6-methyl-3-pyridyl)carbonyl]-amino]]-(4-hydroxyphenyl)acetyl]amino-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylate sodium.

The following infections caused by bacteria sensitive to this drug from the genera Staphylococcus aureus, Streptococcus (except enterococci), anaerobic cocci, anaerobic streptococci, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Proteus, Proteus morganii, Pseudomonas, Haemophilus influenzae, Acinetobacter, and Bacteroides: 1. Sepsis; 2. Secondary infections of burns, surgical incisions, etc.; 3. Pharyngitis (throat abscess), acute bronchitis , tonsillitis (peritonsillitis, peritonsillar abscess), chronic bronchitis, bronchiectasis (when infected), secondary infection of chronic respiratory diseases, pneumonia, lung abscess, empyema; 4. pyelitis, cholangitis; 5. peritonitis (including pelvic peritonitis, bladder and rectal pouch abscess); 6. adnexitis, intrauterine infection, pelvic inflammatory disease, parametrial connective tissue inflammation, vestibular glanditis; 7. meningitis; 8. jaw arthritis, cellulitis around the jaw.

The usual dose for adults is 1-2 g of cefpiramide per day, divided into 2 intravenous injections or intravenous drips. In case of refractory or severe infection, the dose can be increased to 4 g per day, divided into 2-3 intravenous drips, depending on the symptoms. The usual dose for children is 30-80 mg per kilogram per day, divided into 2-3 intravenous drips. In case of refractory or severe infection, the dose can be increased to 150 mg per kilogram per day, divided into 2-3 intravenous drips, depending on the symptoms. Dosage and precautions: (1) When intravenously dripping this product, add it to glucose solution, electrolyte solution, amino acid solution, etc., and The infusion should be completed in 30 to 60 minutes; (2) This drug can only be used for intravenous administration. Do not use water for injection to dissolve the drug for intravenous infusion because the solution is not isotonic; (3) When large doses are administered intravenously, vascular irritation and thrombophlebitis may sometimes occur. In order to prevent such symptoms, attention should be paid to the dissolution of the injection solution, the selection of the injection site, the injection method, etc. The injection speed should be as slow as possible; (4) After dissolution, it must be used quickly. If it needs to be stored, it must be used within 24 hours. (5) Cefpiramide should not be mixed with other drugs in the same container for intravenous infusion.

According to literature reports, in the statistical analysis of 15,442 cases of clinical studies conducted before and after the product was launched, 617 cases (4%) had adverse reactions and abnormal laboratory tests. These were mainly rare digestive symptoms such as diarrhea and nausea, as well as skin symptoms such as rash, blood abnormalities such as leukopenia and eosinophilia, renal function abnormalities such as increased BUN and creatinine, and liver function abnormalities such as increased GOT and GPT. 1. Serious adverse reactions 1. Anaphylactic shock (0.1%) Observe closely, stop the drug when symptoms occur, and take appropriate measures. 2. Severe renal dysfunction such as acute renal failure (0.1%) Check renal function and observe closely. If abnormality is found, stop taking the drug and take appropriate measures. 3. Severe colitis with bloody stools such as pseudomembranous colitis (0.1%) should stop taking the drug immediately and take appropriate measures if abdominal pain, frequent diarrhea and other symptoms occur. 4. Interstitial pneumonia, eosinophilic pulmonary infiltration syndrome (0.1% = fever, cough, dyspnea, abnormal chest X-ray, eosinophilia and other symptoms occur, stop taking the drug, give corticosteroids and take appropriate measures. 2. Serious adverse reactions of similar drugs 1. Malignant bullous erythema multiforme (Stevens-Johnson syndrome), poisoning 1. Lyell's syndrome: It has been reported that malignant bullous erythema multiforme (Stevens-Johnson syndrome) and toxic epidermal necrosis syndrome (Lyell's syndrome) have occasionally been seen when other cephalosporin antibiotics are used. Close observation is required. If abnormalities occur, the drug should be discontinued and appropriate treatment should be given. 2. Hemolytic anemia: It has been reported that hemolytic anemia has occurred when other cephalosporin antibiotics (CET, CER, etc.) are used. If abnormalities are found, the drug should be discontinued and appropriate treatment should be given. 3. Other adverse reactions: When the following adverse reactions occur, appropriate measures such as reducing the dose or discontinuing the drug should be taken as needed. 0.1 %～5%〈0.1%Allergic reactionRash, itching, feverUrticaria, redness of the skin, joint pain, etc.Hematological systemNeutropenia, eosinophiliaAnemia, thrombocytopeniaLiver GOT, GPT, AL-P, LDHElevatedBilirubin, Y-GPTElevatedDigestive systemDiarrhea, nausea, vomitingLoss of appetite, etc.Double infectionStomatitis, candidal infectionVitamin deficiencySymptoms of vitamin K deficiency (hypoprothrombinemia, bleeding tendency, etc.)Symptoms of vitamin B deficiency (glossitis, stomatitis, loss of appetite, neuritis, etc.)OthersHeadache, heat sensation, general malaise*When these symptoms occur, the drug should be discontinued and appropriate treatment should be given.

Patients with a history of anaphylactic shock caused by the ingredients of this drug are contraindicated; patients with a history of allergy to the ingredients of this drug or cephalosporin antibiotics are contraindicated.

(1) Do not drink alcohol or alcoholic beverages. (2) Taking anticoagulants together may produce synergistic effects and cause bleeding. (3) Precautions for simultaneous use Drug name Clinical symptoms and measures Mechanism, risk factors Diuretics (furanolol, azosemide, piretanide, bumetanide, etc.) It has been reported that when used in combination with other cephalosporin antibiotics, renal dysfunction is aggravated by the mechanism, which is not yet clear. It is considered that the dehydration effect of diuretics causes an increase in blood drug concentration.

Keep away from light, tightly closed, in a cool and dry place.

0.25g (calculated as C25H24N8O7S2)