Cefepime Hydrochloride for Injection

Cefepime is a broad-spectrum fourth-generation cephalosporin that achieves bactericidal effects by inhibiting the biosynthesis of bacterial cell walls. In vitro tests have shown that this product is effective against both Gram-positive and Gram-negative bacteria. This product has low affinity for beta-lactamase encoded by bacterial chromosomes, is highly resistant to hydrolysis by most beta-lactamases, and can quickly penetrate into the cells of Gram-negative bacteria. In bacterial cells, its target molecule is penicillin-binding protein (PBP). In vitro and clinical studies have confirmed that this product is active against most of the following microorganisms. Gram-negative aerobic microorganisms: Enterobacter, Klebsiella pneumoniae, Escherichia coli, Proteus mirabilis, Pseudomonas aeruginosa. Gram-positive aerobic microorganisms: Staphylococcus aureus (only for methicillin-sensitive strains), Streptococcus pyogenes (Group A streptococci), Streptococcus pneumoniae. This product is active against most of the following microorganisms in vitro, but there is no sufficient and strict support for the treatment of clinical infectious diseases. Gram-negative aerobic microorganisms: Acinetobacter calcoaceticus, Citrobacter freundii, Citrobacter heteromorphus, Enterobacter agglomerans, Haemophilus influenzae (including beta-lactamase-producing strains), Hafnia alvei, Klebsiella occidentalis, Moracata (including beta-lactamase-producing strains), Proteus vulgaris, Proteus rettii, Providencia stuartii, Serratia marcescens. This product is inactive against most strains of oligotrophomonas. Gram-positive aerobic microorganisms: Staphylococcus epidermidis (only for methicillin-sensitive strains), Staphylococcus saprophyticus, Streptococcus agalactiae (group B streptococci). Most enterococci, such as Enterococcus faecalis and methicillin-resistant Staphylococci, are resistant to this product. Anaerobic microorganisms: Gram-negative rods (including Bacteroides fragilis, other Bacteroides and Fusobacterium species), Gram-positive and Gram-negative cocci (including Peptococcus, Peptostreptococcus and Veillonella species), Gram-positive rods (including Clostridium, Eubacterium and Lactobacillus species).

Cefepime

This product is a sterile mixture of cefepime hydrochloride and an appropriate amount of L-arginine. It is a white to light yellow powder, almost odorless and hygroscopic.

This product can be used to treat moderate to severe infections caused by the above-mentioned sensitive bacteria in adults and children aged 2 months to 16 years, including lower respiratory tract infections (pneumonia and bronchitis), simple lower urinary tract infections and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin and soft tissue infections, complicated intra-abdominal infections (including peritonitis and biliary tract infections), obstetrics and gynecology infections, sepsis, and empirical treatment of patients with neutropenia and fever. It can also be used for bacterial cerebrospinal meningitis in children. Bacterial culture and drug sensitivity testing should be performed when bacterial infection is suspected, but because cefepime is a broad-spectrum bactericidal agent for Gram-positive and Gram-negative bacteria, cefepime monotherapy can be started before the results of drug sensitivity tests are known. When mixed anaerobic infections are suspected, it is recommended to use other anti-anaerobic drugs in combination.

This product can be used for intravenous drip or deep intramuscular injection. For adults and children over 16 years old or children weighing more than 40 kg, 1-2 grams each time can be used according to the condition. Once every 12 hours, intravenous drip, the course of treatment is 7-10 days; mild to moderate urinary tract infection, 0.5-1 gram each time, intravenous drip or deep intramuscular injection, the course of treatment is 7-10 days; severe urinary tract infection, 2 grams each time, once every 12 hours, intravenous drip, the course of treatment is 10 days; for severe infection and life-threatening, 2 grams can be intravenously dripped every 8 hours; for empirical treatment of neutropenia with fever, 2 grams each time, intravenous drip once every 8 hours, the course of treatment is 7-10 days or until neutropenia is relieved. If the fever is relieved but the neutrophil level is still abnormally low, the need for continued antibiotic treatment should be re-evaluated. For children aged 2 months to 12 years, the maximum dose should not exceed the adult dose (i.e., 2 grams each time). For children weighing more than 40 kg, the adult dose can be used. Generally, 40 mg per kg of body weight can be intravenously dripped every 12 hours for a course of 7-14 days; for children with bacterial cerebrospinal meningitis, 50 mg per kg of body weight can be intravenously dripped once every 8 hours. The usual dose for empirical treatment of neutropenia with fever in children is 50 mg per kg of body weight once every 12 hours (treatment of neutropenia with fever is once every 8 hours), and the course of treatment is the same as that for adults. There is limited experience in the treatment of children under 2 months of age. A dose of 50 mg per kg of body weight can be used. However, data from children over 2 months of age show that 30 mg per kg once every 8 or 12 hours is sufficient for pediatric patients aged 1 to 2 months. This product should be used with caution in children under 2 months of age. There is limited experience in deep intramuscular injections in children. There is no need to adjust the dose of this product for patients with hepatic insufficiency. For patients with renal insufficiency, if the creatinine clearance rate is less than (inclusive of) 60 ml/min, the dosage of this product should be adjusted to compensate for the slowed renal clearance rate in these patients. The initial dose of cefepime for these patients is the same as that for patients with normal renal function, and the maintenance dose and dosing interval are as follows: Compared with the normal dosing regimen, the maintenance dosing regimen for adult patients with renal insufficiency with a creatinine clearance (mL/min) > 60 is recommended, the normal dosing regimen is 0.5 g once every 12 hours, 1 g once every 12 hours, 2 g once every 12 hours,

This product is generally well tolerated, with mild and mostly transient adverse reactions, and treatment termination is rare. Common adverse reactions that may be related to this product are mainly diarrhea, rash, and local injection reactions, such as phlebitis, injection site pain and inflammation. Other adverse reactions include nausea, vomiting, allergies, itching, fever, paresthesia, and headache. Patients with renal insufficiency who do not adjust the dose of cefepime accordingly may experience encephalopathy, muscle spasms, and epilepsy. If epilepsy related to treatment occurs, the drug should be discontinued, and anticonvulsant treatment should be given if necessary. This product is used to treat children with meningitis, and occasionally there are convulsions, drowsiness, nervousness, and headaches, which are mainly caused by meningitis and have no obvious relationship with this product. Occasionally, there are reports of enteritis (including pseudomembranous enteritis) and oral candidiasis. Laboratory abnormalities related to this product are mostly transient and can be recovered by stopping the drug, including increased or decreased serum phosphorus, increased aminotransferase (ALT and/or AST), increased eosinophils, and prolonged partial prothrombin time. Alkaline phosphatase, blood urea nitrogen, creatinine, blood potassium, total bilirubin increased, blood calcium decreased, and hematocrit decreased. Similar to other cephalosporin antibiotics, there are also reports of leukopenia, granulocytopenia, and thrombocytopenia. Cephalosporin antibiotics can also cause Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrosis, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, bleeding, liver dysfunction (cholestasis) and cytopenia.

This product is contraindicated in patients with an immediate hypersensitivity reaction to cefepime or L-arginine, cephalosporins, penicillins, or other beta-lactam antibiotics.

Like most beta-lactam antibiotics, cefepime solution should not be added to metronidazole, vancomycin, gentamicin, tobramycin or netilmicin sulfate, aminophylline solution due to drug interactions. Cefepime concentrations exceeding 40 mg/ml should not be added to ampicillin solution. If there is an indication for combined use with this product, these antibiotics should be used separately from this product. Cefepime can cause false positive reactions in urine glucose tests. It is recommended to use the glucose oxidase reaction detection method during treatment with this product.

Keep in a dark, airtight, dry, cool place. Valid for 2 years.

0.5 g

Tentative 18 months

Sinopharm ZHIJUN(Shenzhen)PHARMACEUTICAL Co., Ltd.

• Founded in:

  1985-12-11

• Address:

  No. 16, Lanqing 1st Road, Guanlan High-tech Park, Longhua New District, Shenzhen

• Tax NO.:

  91440300192190290M

• Registered Funds:

  200 million yuan

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