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Cefotaxime

A Reappraisal of its Antibacterial Activity and Pharmacokinetic Properties, and a Review of its Therapeutic Efficacy When Administered Twice Daily for the Treatment of Mild to Moderate Infections

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Summary

Synopsis

Cefotaxime is well established as an effective and well tolerated antibacterial drug for 3 times daily parenteral treatment of a variety of moderate to severe infections in hospitalised patients. Its frequency of administration has recently been reassessed with a 12-hourly regimen.

Comparative studies in hospitalised patients with nosocomial or community-acquired lower respiratory tract infections, demonstrate the similar clinical and bacteriological efficacy of twice daily cefotaxime 1 or 2g and the same daily dose of ceftriaxone, usually administered once daily. Cefotaxime 2g twice daily was also similar in efficacy to ceftriaxone 2g once daily. Retrospective and post-marketing studies also reveal the similar efficacy of cefotaxime administered twice and 3 times daily, and pharmacoeconomic studies suggest that total direct costs of treatment with cefotaxime compared is similar to that with other third generation cephalosporins in currently used dosage regimens.

When administered twice daily, cefotaxime is, thus, an effective antibacterial agent for the treatment of hospitalised patients outside the intensive care unit with a variety of mild to moderate non-CNS infections caused by susceptible organisms. When appropriately administered twice daily there is potential to lower the cost of antibacterial treatment without compromising efficacy.

Antibacterial Activity

Recent studies involving large numbers of clinical isolates of Enterobacteriaceae from intensive care and haematology and/or oncology units in Europe and medical centres in the US confirm earlier data indicating that the antibacterial activity of cefotaxime is generally similar to that of ceftazidime and ceftriaxone, and superior to that of cefuroxime, against Enterobacteriaceae. Tested strains of both ampicillin-susceptible and -resistant Haemophilus influenzae are susceptible to low concentrations (≤0.07 mg/L) of cefotaxime, and 90% of Moraxella catarrhalis and Neiserria gonorrhoeae strains (both penicillin-susceptible and -resistant) were inhibited by cefotaxime ≤0.5 mg/L.

Cefotaxime is more active than ceftazidime against methicillin-susceptible Staphylococcus aureus [minimum inhibitory concentration (MIC) ≈ 4 mg/L], S. epidermidis and Streptococcus pneumoniae, and in most studies the minimum inhibitory cefotaxime concentration for 90% (MIC90) of S. pneumoniae was ≤0.25 mg/L. The susceptibility of viridans streptococci to cefotaxime varies, but MIC90 values were generally between 0.12 and 2 mg/L. The MIC90 values of cefotaxime for Bacteroides fragilis ranged from 1.56 to 32 mg/L.

The active metabolite of cefotaxime, desacetyl-cefotaxime, exhibits antibacterial activity that is generally less than that of the parent drug. There is evidence that desacetyl-cefotaxime may prolong the microbiological action of cefotaxime, particularly when both substances have inherent activity against an organism, and the synergistic interaction between cefotaxime and desacetyl-cefotaxime against some organisms is well documented. A combination of cefotaxime and desacetyl-cefotaxime exhibited synergy or partial synergy against the majority of tested susceptible Enterobacteriaceae and the majority of B. fragilis. These findings may explain in part the enhanced activity of cefotaxime in vivo compared with that expected from in vitro microbiological results.

Synergy between cefotaxime and aminoglycosides has been shown for some Enterobacteriaceae. Cefotaxime and ampicillin have shown synergism against Listeria monocytogenes and cefotaxime and amoxicillin against Enterococcus faecalis. Similarly, combinations of cefotaxime with fosfomycin showed synergy against S. pneumoniae in vitro, a finding which was confirmed in vivo using the fibrin clot model. Recent studies have documented the in vitro synergistic effect between cefotaxime and vancomycin or teicoplanin against resistant strains of S. pneumoniae. A combination of cefotaxime and ofloxacin was synergistic against the great majority of Enterobacteriaceae and Pseudomonas aeruginosa and all tested S. pneumoniae.

Epidemiological studies have generally indicated that the susceptibility to cefotaxime of Gram-negative aerobic bacteria, particularly Enterobacteriaceae, has remained relatively stable over a period of 3 to 5 years.

Pharmacokinetic Properties

Single-dose intravenous administration of cefotaxime 1 and 2g results in mean maximum plasma concentrations (Cmax) of 81 to 102 and 174 to 214 mg/L, respectively. Cmax values after intramuscular administration of cefotaxime are about one-quarter to one-third of those after intravenous administration of the same dose. The plasma concentration of cefotaxime exceeds that of desacetyl-cefotaxime for about 2 hours after single-dose intravenous administration; plasma concentrations 8 hours after a 30-minute infusion of cefotaxime 2g were 0.51 and 1.09 mg/L for cefotaxime and desacetyl-cefotaxime, respectively. Compared with healthy volunteers, plasma concentrations are somewhat higher in elderly patients with bacteraemia. After 12 hours, plasma desacetyl-cefotaxime concentrations were higher than those of cefotaxime.

Earlier studies have shown, and more recent studies confirmed, that cefotaxime concentrations shown to be inhibitory to susceptible bacteria in vitro are achieved in most body tissues following administration of usual therapeutic dosages. The mean plasma elimination half-life (t½β) of 0.82 to 1.43 hours for cefotaxime and 2.02 to 2.13 hours for desacetyl-cefotaxime in healthy volunteers is prolonged in preterm and low birth-weight neonates, in elderly patients [mean creatinine clearance of 42 ml/min (2.52 L/h)], in patients with renal impairment (creatinine clearance <10 ml/min) and in patients with cirrhosis and ascites or chronic parenchymal liver disease and jaundice.

The t½β of individual third generation cephalosporins has often been used as a principal determinant for selection of dose interval, and in some instances, of a particular drug within this class. However, determinants of effective antimicrobial therapy include many other pharmacokinetic, pharmacodynamic and clinical properties. The antibacterial efficacy of β-lactam antibiotics is time-rather than concentration-dependent, and because of the importance of MIC values, surrogate relationships that relate pharmacokinetic parameters to MIC have been studied. Included among these are the time that the plasma concentration of the drug exceeds the MIC (time > MIC), Cmax to MIC ratio and area under the inhibitory concentration-time curve (AUIC24). After treatment with cefotaxime there was a correlation between the time > MIC and the numbers of bacteria remaining in the lungs of mice with K. pneumoniae infection. Also, threshold values for AUIC24 defined in animal studies are achieved for a variety of bacteria following twice daily administration of cefotaxime to healthy volunteers. Thus, it appears feasible to administer cefotaxime 1 or 2g 12-hourly as monotherapy to adults for treatment of infection caused by bacteria with an MIC of ≤1 mg/L.

Therapeutic Efficacy

The efficacy of cefotaxime intravenous or intramuscular twice daily has been studied in hospitalised patients with a variety of infections. Studies comparing cefotaxime with other antimicrobial drugs randomly allocated patients to treatment groups, but typically, microbiological documentation was available in only a minority of patients. Few studies provided details of follow-up procedures or efficacy data at specified periods after the end of treatment. Most often the efficacy of cefotaxime was compared with that of ceftriaxone. In patients with nosocomial pneumonia, the efficacy of cefotaxime 2g twice daily was similar to that of ceftriaxone 2g twice daily, and cefotaxime 2g 3 times daily initially, followed by twice daily administration, was more clinically effective than routinely used antibacterial regimens.

When administered intravenously or intramuscularly in the treatment of patients with community-acquired pneumonia, bronchopneumonia or acute exacerbation of chronic bronchitis, the efficacy of cefotaxime 1g twice daily was similar to that of ceftriaxone 1g twice or once daily administered by the same route. At the higher dosage of 2g twice daily intravenously, cefotaxime had similar clinical efficacy to ceftriaxone 2g once daily administered by the same route and a short course of cefotaxime 2g twice daily followed by cefixime 400mg once daily orally. The bacteriological efficacy of cefotaxime and ceftriaxone was also generally similar.

Patients in an intensive care unit who developed serious lower respiratory tract infections responded similarly to treatment with cefotaxime 2g twice or 3 times daily.

Cefotaxime 2g twice daily had similar clinical and bacteriological efficacy to the same dosage regimen of aztreonam in patients with complicated and/or nosocomial urinary tract infection. In another study, the rate of eradication or presumed eradication of pathogens in patients with serious urinary tract infections treated with cefotaxime 2g twice daily was not significantly different compared with that with ceftriaxone 2g once daily.

Twice daily intravenous administration of cefotaxime 2g has also been shown to be at least as effective as ceftriaxone in the treatment of skin and soft tissue infections.

A postmarketing surveillance study in hospitalised patients (n=1636) revealed that clinical and bacteriological response rates were similar following treatment with cefotaxime 2g twice or 3 times daily. Similarly, retrospective analysis of results of treatment of bacteraemia, septicaemia, urogenital, intra-abdominal, CNS or lower respiratory tract infections with cefotaxime showed a clinical response rate in 97 and 96% of patients treated with cefotaxime 1 and 2g twice daily, respectively. Retrospective clinical evaluation of the same regimens in elderly Japanese patients with pneumonia indicated that clinical efficacy was not influenced by underlying hepatic, renal, haematological or neurological disease, but was decreased in patients with initially poor health status and in those with concomitant lung neoplasm.

Tolerability

The majority of adverse events associated with cefotaxime are mild and transient. There is no reliable indication of the relative incidence of adverse events during twice daily versus more frequent administration of cefotaxime. However, the tolerability profile appears similar with twice daily and more frequent regimens, with mild gastrointestinal complaints being the most common events, followed by pruritus, rash and phlebitis at the injection site. The incidence of adverse events in patients treated with a variety of regimens of cefotaxime was between 5 and 8%, with discontinuation necessary in only 1 to 2%.

In comparative studies, the incidence of adverse events was reported to be similar with cefotaxime and ceftriaxone, or in some instances greater with ceftriaxone, which caused a higher incidence of digestive adverse events.

Pharmacoeconomic Considerations

The relative costs of treatment with the third generation cephalosporins have been determined from known acquisition costs alone, from acquisition, preparation and administration costs, and from total direct costs including acquisition, preparation, monitoring and estimated costs arising from complications. Whether there are real cost differences between cefotaxime and ceftriaxone with respect to laboratory monitoring and adverse events is debatable. Comparative cost information from direct measurement of difference in disease course or outcome is not yet available. When assessed by each of these methods, the averaged cost of treatment with cefotaxime (mostly 3 times daily) has mostly been lower than that with ceftriaxone once or twice daily. Substitution of cefotaxime for ceftriaxone has also been associated with cost savings, although contrary findings have also been reported. There appears to be further potential for cost containment if cefotaxime is administered twice daily.

Dosage and Administration

When administered twice daily (12-hourly), the recommended dose of cefotaxime is usually 1 to 2g, intravenously or intramuscularly. Twice daily administration should be considered in the treatment of monomicrobial infections caused by susceptible organisms, in patients without neutropenia and not in an intensive care unit. Twice daily administration may also be considered in the treatment of moderately serious infection caused by susceptible organisms in elderly patients, who would be expected to eliminate the drug more slowly than younger patients.

It is not yet clear how long administration should be continued after patients become afebrile or have other evidence of bacterial elimination. Prudence and anecdotal experience suggest that administration for an additional 48 to 72 hours is appropriate.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    Rex N. Brogden & Caroline M. Spencer

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  1. Rex N. Brogden
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Correspondence to Rex N. Brogden.

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Various sections of the manuscript reviewed by: W.R. Bowie, Division of Infectious Diseases, University of British Columbia, Vancouver, British Columbia, Canada; R.G. Finch, Department of Microbial Diseases, The City Hospital, Nottingham, England; D.H.E. Gladen, Valley Medical Center, Fresno, California, USA; R.N. Jones, Department of Pathology, University of Iowa College of Medicine, Iowa City, Iowa, USA; U, Kumazawa, Faculty of Medicine, Kyushu University, Fukuoka, Japan; S.W.B Newsom, Departments of Geriatrics and Bacteriology, Papworth Hospital, Cambridge, England; A. Rimola, Liver Unit, Hospital Clinic i Provincial, Villarroel, Barcelona, Spain.

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Brogden, R.N., Spencer, C.M. Cefotaxime. Drugs 53, 483–510 (1997). https://doi.org/10.2165/00003495-199753030-00009

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