Xinliwei Cefepime Hydrochloride for Injection

1. Indications and Usage
Serious Infections: Treatment of moderate to severe infections caused by susceptible bacteria, including pneumonia, urinary tract infections, skin and soft tissue infections, and pyogenic infections.
Sepsis and Meningitis: Treatment of septicemia and meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Neisseria meningitidis.
Complicated Intrapertoneal Infections: Treatment of complicated intra-abdominal infections in combination with metronidazole.
Prophylactic Use: Preoperative prophylaxis to reduce the risk of postoperative infections.
2. Dosage and Administration
Adults: The usual dosage is 1 g administered every 8 to 12 hours. For severe infections, 2 g every 8 hours may be used.
Pediatrics: The usual pediatric dosage is 50 mg/kg/day divided into 3 or 4 equal doses. For meningitis, 150 mg/kg/day may be used.
Renal Impairment: Dosage must be adjusted based on creatinine clearance to prevent drug accumulation.
Administration: Can be administered via intramuscular injection or intravenous infusion (infusion over 15 to 30 minutes).
3. Mechanism of Action
Cell Wall Inhibition: Cefepime is a bactericidal agent that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
Spectrum: It demonstrates broad-spectrum activity against many Gram-positive and Gram-negative bacteria, including Pseudomonas aeruginosa, and is highly stable against many beta-lactamases.
4. Safety and Warnings
Hypersensitivity: Severe and occasionally fatal hypersensitivity reactions have been reported. It should not be used in patients with a history of immediate hypersensitivity to cephalosporins.
Neurotoxicity: In patients with severe renal impairment, high doses may lead to central nervous system toxicity, including seizures.
Pseudomembranous Colitis: Broad-spectrum antibiotics may cause pseudomembranous colitis; use with caution in patients with a history of gastrointestinal disease.
Coagulation: Cephalosporins may interfere with vitamin K metabolism, potentially increasing the risk of bleeding.
5. Adverse Reactions and Clinical Research
Common: Gastrointestinal symptoms such as diarrhea, nausea, vomiting, injection site reactions, and transient elevation of liver enzymes.
Serious: Hypersensitivity reactions (including anaphylaxis), seizures, eosinophilia, and pseudomembranous colitis.
Clinical Research: Pivotal clinical trials have demonstrated high efficacy and safety against resistant pathogens and in immunocompromised patients.
6. Drug Interactions
Aminoglycosides: Concomitant use may enhance the risk of nephrotoxicity.
Probenecid: Can delay the renal excretion of cefepime, increasing blood concentrations and half-life.
Warfarin: May enhance the anticoagulant effect; prothrombin time should be monitored.
7. Pharmaceutical Information
Active Ingredient: Cefepime Hydrochloride.
Excipients: Sodium acetate.
Appearance: White to yellowish-white lyophilized powder or crystals.
Storage: Store in a well-closed container, protected from light and moisture.