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Cefepime

A Review of its Antibacterial Activity, Pharmacokinetic Properties and Therapeutic Use

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Abstract

Synopsis

Cefepime is a ‘fourth’ generation Cephalosporin that has a broader spectrum of antibacterial activity than the third generation Cephalosporins and is more active in vitro against Gram-positive aerobic bacteria. The fact that cefepime is stable to hydrolysis by many of the common plasmid and chromosomally-mediated β-lactamases, and that it is a poor inducer of type I β-lactamases, indicates that cefepime may be useful for treatment of infections resistant to earlier Cephalosporins.

In comparative trials, cefepime 1 to 2g, usually administered intravenously twice daily, was as effective as ceftazidime 1 to 2g, usually administered 3 times daily, for treatment ofbacteraemia and infections of the lower respiratory tract, urinary tract, pelvis and skin and skin structures. Furthermore, cefepime was as effective as ceftazidime and piperacillin or mezlocillin in combination with gentamicin when administered as empirical treatment for fever in patients with neutropenia. A limited number of trials have found cefepime to be as effective as cefotaxime for the treatment of gynaecological and lower respiratory tract infections. Similarly, cefepime 2g twice daily intravenously (alone or in combination with metronidazole) was as effective as gentamicin in combination with mezlocillin or Clindamycin, respectively, for the treatment of intra-abdominal infection.

Cefepime has a linear pharmacokinetic profile, an elimination half-life of approximately 2 hours and is primarily excreted by renal mechanisms as unchanged drug. Cefepime has a tolerability profile similar to that of other parenteral Cephalosporins; adverse events are primarily gastrointestinal in nature. A total of 1.4 and 2.9% of patients receiving cefepime ≤2 g/day and =2 g/day, respectively, required treatment withdrawal as a result of any adverse event.

Thus, cefepime has the advantage of an improved spectrum of antibacterial activity, and is less susceptible to hydrolysis by some β-lactamases, compared with third generation Cephalosporins. Despite these advantages, cefepime has not been found to be more effective than ceftazidime and cefotaxime in clinical trials, although most trials selected patients with organisms sensitive in vitro to both comparator agents. Further trials, particularly in areas of widespread bacterial resistance, are required to confirm the positioning of cefepime for treatment of serious infection, and in particular to further explore whether its potential advantages result in clinical benefits.

Antibacterial Activity

Cefepime is a Cephalosporin with activity against both Gram-positive and Gram-negative aerobic bacteria. In common with other β-lactam agents, cefepime exerts its antibacterial effects by binding to penicillin-binding proteins.

Cefepime has greater inhibitory activity than ceftazidime against Streptococcus pneumoniae and most other streptococcal species, and against staphylococcal species. Although cefepime is active against methicillin-sensitive strains, it is not active against methicillin-resistant Staphylococcus aureus or S. epidermidis. Cefepime demonstrates useful inhibitory activity against all common pathogens from the family Enterobacteriaceae, including those that commonly produce chromosomally-mediated β-lactamases. Cefepime also has excellent inhibitory activity against Haemophilus influenzae, regardless of the α-lactamase-producing ability of the organism. In common with most other Cephalosporins, cefepime has limited inhibitory activity against non-fermentative bacteria, although the majority of tested isolates of Pseudomonas aeruginosa were susceptible or moderately susceptible to cefepime, Cefepime has minimal inhibitory activity against enterococci, Bacteroides fragilis and Clostridium difficile.

Type I β-lactamases have a low affinity for cefepime, and therefore cefepime retains its inhibitory activity against de-repressed bacteria. In addition, cefepime is not susceptible to hydrolysis by plasmid-mediated β-lactamases expressed by Gram-negative bacteria, particularly Enterobacter species. Furthermore, unlike imipenem and some second generation Cephalosporins, cefepime is a poor inducer of type I β-lactamases.

Experimental models of infection have generally found cefepime to have activity superior to that of ceftazidime and cefotaxime against most clinically important Gram-positive and Gram-negative organisms. However, against infections caused by P. aeruginosa, cefepime had activity similar to that of ceftazidime.

Pharmacokinetic Properties

In healthy volunteers, cefepime reaches maximum serum concentrations (Cmax) of approximately 57.5 mg/L after administration of a 2g dose by intramuscular injection. The same dose of cefepime administered intravenously over a period of 30 minutes achieves higher serum concentrations than intramuscular administration, with Cmax values ranging from 126 to 193 mg/L. The drug has linear pharmacokinetics and an elimination half-life (t1/2β) of approximately 2 hours. Plasma protein binding is low, and the drug distributes widely into body tissues and fluids. Cefepime is primarily excreted by renal mechanisms as unchanged drug. The t1/2β of cefepime increases and clearance decreases progressively as renal function declines, necessitating dosage reduction in patients with renal impairment. Haemodialysis and haemofiltration remove cefepime from the systemic circulation with a t1/2β approximating that observed in individuals with normal renal function. Cefepime is removed to a lesser extent by continuous peritoneal dialysis.

Differences observed in the pharmacokinetic profile of cefepime in patients with lower respiratory tract infections, sepsis, or cystic fibrosis were not sufficient enough to require modified dosage recommendations for these patients.

Therapeutic Efficacy

Although the results of few comparative trials have been published to date, cefepime, administered intravenously or intramuscularly, has demonstrated efficacy in the treatment of bacteraemia, upper and lower respiratory tract infections, urinary tract infections, skin, skin structure and bone infections and gynaecological infections. Trials have been undertaken in US, European and Japanese patients.

The majority of comparative trials have compared the efficacy of cefepime with that of a third generation Cephalosporin ceftazidime. In most trials, equigravimetric doses were given; however, generally cefepime was administered intravenously twice daily and ceftazidime was administered intravenously 3 times daily. As treatment for nosocomial and community-acquired lower respiratory tract infections, cefepime is as effective as ceftazidime; both clinical (62 to 90% vs 64 to 94%) and bacteriological (69 to 97 vs 63 to 100%) efficacy rates were comparable in all studies. Although S. aureus and P. aeruginosa persisted most frequently, the numbers of pathogens were insufficient to differentiate between the comparator agents. Similarly, the efficacy of cefepime and ceftazidime could not be differentiated on the basis of recurrence of infection, which was rare. Cefepime also has efficacy comparable to that of ceftazidime in the treatment of bacteraemia, urinary tract infection and skin and skin structure infection. For example, clinical cure rates in patients with complicated urinary tract infection were 72 to 89% for patients receiving cefepime and 60 to 88% for ceftazidime-treated patients.

Cefepime 2g twice daily has been compared with cefotaxime 2g three times daily in patients with nosocomial lower respiratory tract infections and in patients with gynaecological infection. In these trials, the clinical and microbiological efficacy of cefepime and cefotaxime were comparable. Similarly, as treatment of intra-abdominal infection, the clinical efficacy of intravenous cefepime 2g twice daily (alone or in combination with metronidazole) was similar to that of a standard dosage of gentamicin in combination with either mezlocillin 3 to 4g every 4 to 6 hours or Clindamycin 0.9g every 8 hours, respectively.

Importantly, cefepime 2g three times daily was as effective as ceftazidime 2g three times daily, or a standard dosage regimen of piperacillin or mezlocillin in combination with gentamicin, as empirical treatment for fever in patients with neutropenia.

Tolerability

Cefepime has been well tolerated by adults in clinical trials conducted worldwide. Tolerability data pooled from clinical trials undertaken in North America and Europe indicate that cefepime has a tolerability profile similar to that of ceftazidime. The incidence of treatment withdrawal appeared to be dosage-related; therapy was discontinued because of an adverse event in 1.4% of patients receiving cefepime ≤2 g/day and in 2.9% of patients receiving cefepime =2 g/day.

A total of 20.3% of patients receiving cefepime in comparative trials experienced an adverse event, an incidence comparable to that observed in patients receiving ceftazidime. Gastrointestinal symptoms, including nausea (1.8%), diarrhoea (1.7%), vomiting (1.5%) and constipation (1.2%), and headache (3.2%) and rash (1.8%) were the most commonly occurring adverse events experienced by cefepime-treated patients.

Clinically relevant laboratory abnormalities were observed infrequently. Abnormal liver function tests were reported in ≤2.4% of patients receiving cefepime. A positive Coombs’ test was the most commonly occurring laboratory abnormality, but the clinical significance of this is unclear as no episodes of haemolysis were reported.

Intravenous and intramuscular administration of cefepime appeared to be well tolerated locally.

Dosage and Administration

Cefepime is generally administered by short intravenous infusion, but may also be administered by intramuscular injection. The most common dosage of cefepime in clinical trials was 2 or 4g daily administered in 2 divided doses; however, daily dosages as low as 1g and as high as 6g have been administered to adult patients.

The daily dosage of cefepime should be modified in patients with renal impairment. Depending on the severity of infection, the dosage and/or frequency of administration should be reduced in patients with Creatinine clearance (CLCR) values below 1.8 L/h (30 ml/min). For patients with a CLCR of between 0.66 and 1.8 L/h (11 and 30 ml/min) a dose of 1g once or twice daily or 0.5g twice daily is recommended, while 0.25 to 1g daily is recommended for patients with a CLCR of <0.6 L/h (10 ml/min). Patients undergoing haemodialysis or haemofiltration should be given a supplementary dose of cefepime 0.25g following every dialysis period. Patients undergoing peritoneal dialysis should receive cefepime 0.25 to 1g every 48 hours to maintain therapeutic cefepime concentrations.

Insufficient data are available to make any recommendations concerning the optimal dosage of cefepime in children; however, cefepime 50 mg/kg every 8 hours (to a maximum dose of 2g) has been administered to children with cystic fibrosis.

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Various sections of the manuscript reviewed by: R.B. Ellis-Pegler, Infectious Disease Unit, Auckland Hospital, Auckland, New Zealand; F. Fraschini, Dipartimento di Farmacologia, Chemioterapia E Tossicologia Medica, Milano, Italy; G. Gialdroni Grassi, Facolta di Medicina e Chirurgia, Università di Privia, Milano, Italy; A.M. Hoepelman, Department of Internal Medicine, Section of Clinical Immunology and Infectious Diseases, University Hospital Utrecht, Utrecht, The Netherlands; J.E. Hoppe, University Children’s Hospital, Tübingen, Germany; J. Kumazawa, Department of Urology, Faculty of Medicine, Kyushu University, Fukuoka, Japan; D.R Levine, Department of Medicine, Division of Infectious Diseases, Detroit Receiving Hospital and University Health Center, Detroit, Michigan, USA; M.P. Okamoto, Clinical Research Division, Kaiser Permanente, Southern California Region, Downey, California, USA; A. Saito, The First Department of Internal Medicine, Faculty of Medicine, University Ryukyus, Okinawa, Japan; C.C. Sanders, Department of Medical Microbiology, Creighton University School of Medicine, Omaha, Nebraska, USA.

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Barradell, L.B., Bryson, H.M. Cefepime. Drugs 47, 471–505 (1994). https://doi.org/10.2165/00003495-199447030-00007

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