Cefepime

Clinical summary

Indications and usage Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia ( 1.1 ); empiric therapy for febrile neutropenic patients ( 1.2 ); uncomplicated and complicated urinary tract infections ( 1.3 ); uncomplicated skin and skin structure infections ( 1.4 ); and complicated intra-abdominal infections (used in combination with metronidazole) ( 1.5 ). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefepime Injection and other antibacterial drugs, Cefepime Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) Standard dosing Recommended Dosage in Adults With Creatinine Clearance (CrCL) Greater Than 60 mL/min ( 2.1 ) Site and Type of Infection (Adults) Dose (IV) Frequency Duration (Days) Moderate to Severe Pneumonia For Pseudomonas aeruginosa , use 2 g IV every 8 hours ( 2.1 ) 1-2 g Every 8-12 hours 10 Empiric therapy for febrile neutropenic patients 2 g Every 8 hours 7 Or until resolution of neutropenia ( 2.1 ) Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections 0.5-1 g Every 12 hours 7-10 Severe Uncomplicated or Complicated Urinary Tract Infections 2 g Every 12 hours 10 Moderate to Severe Uncomplicated Skin and Skin Structure Infections 2 g Every 12 hours 10 Complicated Intra-abdominal Infections (used in combination with metronidazole) 2 g Every 8-12 hours 7-10 • Pediatric Patients (2 months to 16 years) – Recommended dosage in pediatric with CrCL greater than 60 mL/min. ( 2.2 ) • The usual recommended dosage in pediatric patients is 50 mg per kg per dose administered every 12 hours (every 8 hours for febrile neutropenia). ( 2.2 ) • Cefepime Injection in Galaxy Container should be used only in pediatric patients who require the entire 1 gram or 2 gram dose and not any fraction thereof. ( 2.2 ) • Patients with Renal Impairment: Adjust dose in patients with CrCL less than or equal to 60 mL/min. ( 2.3 ) • Administer intravenously over approximately 30 minutes. ( 2.1 ) • Do not force thaw frozen container by immersion in water baths or by microwave irradiation. ( 2.4 ) Contraindications Cefepime Injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterials, penicillins or other beta-lactam antibacterial drugs. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products. Key warnings • Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefepime Injection occurs, discontinue the drug. ( 5.1 ) • Neurotoxicity: May occur especially in patients with renal impairment administered unadjusted doses. If neurotoxicity associated with Cefepime Injection therapy occurs, discontinue the drug. ( 5.2 ) • Clostridioides difficile Associated Diarrhea (CDAD): Evaluate if diarrhea occurs. ( 5.3 ) Drug interactions • Aminoglycosides -- increased potential of nephrotoxicity and ototoxicity. ( 7.2 ) • Diuretics -- nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. ( 7.3 ) Pregnancy guidance Risk summary There are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. Available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). Cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during the period of organogenesis. The doses used in these studies were 1.6 times (rats), approximately equal to (mice) and 0.3 times (rabbits) the maximum recommended clinical dose ( see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal data Cefepim