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 beta-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), inhibiting the synthesis of bacterial cell wall, thereby exerting a bactericidal effect.

Cefpiramide sodium.

This product is white to off-white lump or powder.

It is suitable for the following infections caused by bacteria sensitive to this drug from the genera of Staphylococcus aureus, Streptococcus (except enterococci), anaerobic cocci, anaerobic streptococci, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Proteus, Morganella, Pseudomonas, Haemophilus influenzae, Acinetobacter, and Bacteroides: 1. Sepsis; 2. Secondary infections such as burns and surgical incisions; 3. Pharyngitis (throat abscess), acute bronchitis 1. Chronic bronchitis, bronchiectasis (when infected), secondary infection of chronic respiratory diseases, pneumonia, lung abscess, empyema; 2. Pyelonephritis, cholangitis; 3. Peritonitis (including pelvic peritonitis and bladder and rectal pouch abscess); 4. Adnexitis, intrauterine infection, pelvic inflammatory disease, parametrial connective tissue inflammation, Bartholinitis; 5. Meningitis; 6. Jaw arthritis and perimandibular cellulitis.

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, it can be increased to 4 g per day, divided into 2-3 intravenous drips according to different 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, it can be increased to 150 mg per kilogram per day, divided into 2-3 intravenous drips according to different symptoms.

According to literature reports, among the 15,442 cases of clinical studies conducted before and after the product was marketed, 617 cases (4%) had adverse reactions and laboratory abnormalities. 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, creatine, and creatinine, and liver function abnormalities such as increased GOT and GPT. 1 Serious adverse reactions (1) Anaphylactic shock (0.1%) Closely observe, discontinue the drug when symptoms occur, and take appropriate measures. (2) Severe renal dysfunction such as acute renal failure (0.1%) Regularly check renal function, closely observe, and discontinue the drug when abnormalities are found, and take appropriate measures. (3) Severe colitis with bloody stools such as pseudomembranous colitis (0.1%) When abdominal pain, frequent diarrhea, and other symptoms occur, discontinue the drug immediately and take appropriate measures. (4) Interstitial pneumonia, eosinophilic lung infiltration syndrome (0.1%) When fever, cough, dyspnea, abnormal chest X-ray, eosinophilia and other symptoms occur, the drug should be discontinued, corticosteroids should be given, and appropriate treatment should be carried out. 2 Serious adverse reactions of similar drugs (1) Malignant bullous erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrosis syndrome (Lyell syndrome) It has been reported that malignant bullous erythema multiforme (Stevens-Johnson syndrome) and toxic epidermal necrosis syndrome (Lyell syndrome) are occasionally seen when other cephalosporin antibiotics are used. Close observation should be made. If abnormalities occur, the drug should be discontinued and appropriate treatment should be carried out. (2) Hemolytic anemia It has been reported that hemolytic anemia occurs when other cephalosporin antibiotics (CET, CER, etc.) are used. If abnormalities are found, the drug should be discontinued and appropriate treatment should be carried out. (3) Other adverse reactions When the following adverse reactions occur, appropriate measures such as reducing the dose and stopping the drug should be taken as needed. 0.1～5%0.1%Allergic reaction※Rash, itching, fever urticaria, fine spots, redness of the skin, joint pain, etc.Hematological systemNuclear cell decrease, eosinophiliaAnemia, thrombocytopeniaLiverGOT, GPT, AL-P, LDH increaseBilirubin, gamma;-GPT increaseDigestive systemDiarrhea, nausea, vomitingLoss of appetite, etc.Double infectionStomatitis, Candida 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 fatigueWhen such symptoms occur, the drug should be discontinued and appropriate treatment should be taken.

It is contraindicated for patients with a history of anaphylactic shock caused by the ingredients of this drug; it is contraindicated for patients with a history of allergy to the ingredients of this drug or cephalosporin antibiotics.

1. Do not drink alcohol or alcoholic beverages. When taken at the same time, symptoms such as facial flushing, nausea, tachycardia, sweating, and headache may occur. The mechanism is not clear yet, and it may be disulfiram-like symptoms caused by the N-methylthiotetrazolyl thiomethyl group connected to the 3rd position of the cephalosporin structure. 2. Taking anticoagulants at the same time may produce synergistic effects and cause bleeding. 3. Precautions for simultaneous use Drug name, etc. Clinical symptoms and measures Mechanism, risk factors Diuretics (furanosemide, azosemide, piretanide, bumetanide, etc.) have been reported to aggravate renal dysfunction when used in combination with other cephalosporin antibiotics. The mechanism is not yet clear, and it is considered to be caused by the increase in blood drug concentration caused by the dehydration effect of diuretics.

Sealed, store in a cool, dark and dry place.

0.5g (calculated as C25H24N8O7S2)