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 hydrochloride.

This product is 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), obstetric and gynecological 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 tests 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. For suspected mixed anaerobic infections, it is recommended to use other anti-anaerobic drugs, such as metronidazole, for initial treatment. Once the results of bacterial culture and drug sensitivity tests are known, the treatment plan should be adjusted in a timely manner. This product is suitable for preventive medication in patients undergoing abdominal surgery.

This product can be administered by intravenous drip or deep intramuscular injection. For adults and children over 16 years old or children weighing 40 kg or more, 1 to 2 grams each time, once every 12 hours, intravenous drip, for 7 to 10 days, depending on the condition; for mild to moderate urinary tract infection, 0.5 to 1 gram each time, intravenous drip or deep intramuscular injection, for 7 to 10 days; for severe urinary tract infection, 2 grams each time, once every 12 hours, intravenous drip, for 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, intravenously dripped once every 8 hours, for 7 to 10 days or until neutropenia is relieved. If the fever is relieved but the neutrophil level is still abnormally low, the need to continue 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 to 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 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 children aged 1 to 2 months. This product should be used with caution in children under 2 months of age. There is limited experience with 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 recommended maintenance dosing regimen for adult patients with renal insufficiency Creatinine clearance (ml/min) Recommended maintenance dosing regimen >60, 0.5 g each time, 1 g each time, 2 g each time, 2 g each time, Normal dosing regimen Once every 12 hours Once every 12 hours Once every 8 hours 30-60 Each time 0.5 g each time, 1 g each time, 2 g each time, 2 g each time, Once every 24 hours Once every 24 hours Once every 24 hours 11 -29 0.5 g each time, 0.5 g each time, 1 g each time, 2 g each time, once every 24 hours once every 24 hours once every 24 hours <11 0.25 g each time, 0.25 g each time, 0.5 g each time, 1 g each time, once every 24 hours once every 24 hours once every 24 hours once every 24 hours hemodialysis* 0.5 g each time, 0.5 g each time, 0.5 g each time, 0.5 g each time, once every 24 hours once every 24 hours once every 24 hours *Hemodialysis patients can be given a loading dose of 1 g on the first day of treatment, followed by 0.5 g each day. On dialysis days, cefepime should be taken after the end of dialysis. The dosing time should be as similar as possible every day. For patients who need hemodialysis while receiving cefepime, about 68% of the drug can be cleared 3 hours after the start of dialysis. The dose of Maxiprene for hemodialysis patients is shown in the table above. Patients receiving continuous peritoneal dialysis should be given regular doses every 48 hours. There is no data on the use of cefepime in children with renal insufficiency. However, since the pharmacokinetics of cefepime in adults and children are similar, the use of cefepime in children with renal insufficiency is similar to that in adults. Intravenous administration: Intravenous administration should be preferred for severe or life-threatening cases. For intravenous infusion, 1-2 grams of this product can be dissolved in 50-100 ml of 0.9% sodium chloride injection, 5% or 10% glucose injection, M/6 sodium lactate injection, 5% glucose and 0.9% sodium chloride mixed injection, lactated Ringer's and %5 glucose mixed injection. The drug concentration should not exceed 40 mg per ml. The infusion is completed in about 30 minutes. Intramuscular injection: For intramuscular injection, 0.5 grams of this product should be added to 1.5 ml of injection solution, or 1 gram should be dissolved in 3.0 ml and injected through deep muscle groups (such as gluteal muscles or lateral quadriceps femoris).

This product is generally well tolerated, with mild and mostly short-lived 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 may suffer from encephalopathy, muscle spasms, and epilepsy if the dose of cefepime is not adjusted accordingly. If epilepsy related to treatment occurs, the drug should be discontinued, and anticonvulsant treatment should be carried out 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 candida infection. Almost all antibiotics, including cefepime for injection (Maspin), have been reported to have Clostridium difficile associated diarrhea (CDAD) in their use, and the severity ranges from mild diarrhea to fatal colitis. Antimicrobial therapy alters the normal flora of the colon, leading to overgrowth of C. difficile. Toxins A and B produced by C. difficile are responsible for the development of C. difficile-associated diarrhea (CDAD). Strains of C. difficile that produce high levels of toxins are associated with increased morbidity and mortality from CDAD, and since these infections are refractory to antimicrobial therapy, colectomy may be necessary in such patients. The possibility of CADA must be considered in any patient who develops diarrhea after antibiotic therapy. There have been reports of CDAD occurring 2 months after the end of antimicrobial therapy, so a careful history of the patient is required when identifying CADA. Once CADA is suspected or confirmed, the patient may need to stop the antibiotics they are receiving (except for antibiotics that have a direct inhibitory effect on C. difficile). At the same time, appropriate fluid and electrolyte management, protein supplementation, antibiotics for C. difficile infection, and surgical evaluation should be performed as clinically indicated. Laboratory abnormalities associated with this product are mostly transient and can be recovered by stopping the drug, including increased or decreased serum phosphorus, increased transaminases (ALT and/or AST), eosinophilia, and prolonged partial prothrombin time and prothrombin time. Alkaline phosphatase, blood urea nitrogen, creatinine, blood potassium, and total bilirubin are increased, blood calcium is decreased, and hematocrit is 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 hematocytopenia.

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