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Ceftriaxone

A Reappraisal of its Antibacterial Activity and Pharmacokinetic Properties, and an Update on its Therapeutic Use with Particular Reference to Once-Daily Administration

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Summary

Synopsis

Since ceftriaxone was first reviewed in the Journal, further studies have confirmed its broad antibacterial spectrum in vitro and extended its clinical documentation in comparative studies with other widely used drugs in infections of the urinary and lower respiratory tract, meningitis in infants and children, uncomplicated gonorrhoea, perioperative prophylaxis in patients undergoing surgery, and in several other types of infection. As in earlier studies, which primarily used a twice-daily dosage regimen, few significant differences were found between therapeutic groups in comparative studies and results have demonstrated the efficacy of once-daily ceftriaxone in all but the most serious infections, such as sole antibiotic therapy in pseudomonal infections. Wider clinical experience has established that ceftriaxone is generally well tolerated.

Thus, ceftriaxone now has a well-defined place as an appropriate alternative for the parenteral treatment of a variety of infections due to susceptible organisms, as well as for perioperative prophylaxis of surgery, and may offer advantages of greater convenience over other parenteral antibiotics which are administered more frequently.

Antibacterial Activity

Ceftriaxone has a broad spectrum of activity in vitro which includes Gram-positive and Gram-negative aerobic and some anaerobic bacteria. Both penicillin-sensitive and-resistant strains of Staphylococcus aureus are sensitive to ceftriaxone (MIC90 2 to 8 mg/ L), but the drug is poorly active against methicillin- or oxacillin-resistant strains. Ceftriaxone is similar in activity to several penicillins and other cephalosporins against Streptococcus pneumoniae and Streptococcus pyogenes, and is also active in low concentrations against other Streptococcus species (S. agalactiae and viridans streptococci). However, Staphylococcus epidermidis is only moderately sensitive and Streptococcus faecalis is usually resistant to ceftriaxone.

Ceftriaxone is generally more active than cefoperazone (except against Pseudomonas aeruginosa), and is similar in activity to cefotaxime and latamoxef (moxalactam) against Gram-negative bacilli. 90% of tested strains of most Enterobacteriaceae were inhibited by a ceftriaxone concentration of ≤ 1 mg/L, but Enterobacter cloacae is less sensitive. The reported activity of ceftriaxone against Pseudomonas aeruginosa varies widely, but generally at least 32 mg/L is required to inhibit most strains, and is thus usually less active than the aminoglycosides, aztreonam, imipenem, cefoperazone, ceftazidime, carumonam and piperacillin. The combination of ceftriaxone and an aminoglycoside is usually synergistic against P. aeruginosa in vitro (20 to 80% of tested strains). However, synergy is less common against aminoglycoside-resistant and/or multidrug-resistant strains. Ceftriaxone is active at very low concentrations against β-lactamase-positive and -negative strains of Haemophilus influenzae and Neisseria gonorrhoeae and N. meningitidis (all with MIC90 ≤ 0.025 mg/L).

Clostridium difficile and several species of Bacteroides, including B. fragilis, are only moderately sensitive or insensitive to ceftriaxone, but some other anaerobic bacteria are inhibited by the drug.

Ceftriaxone is stable to inactivation by β-lactamases produced by many bacteria, but not to those produced by B. fragilis or by some strains of Klebsiella species, Proteus vulgaris and Pseudomonas cepacia. In general, the β-lactamase stability of ceftriaxone is similar to that of cefotaxime and cefuroxime, which are inactivated by fewer β-lactamases than cefamandole, cephalothin and cephaloridine, but by more β-lactamases than latamoxef and cefoxitin.

Pharmacokinetics

Mean peak plasma concentrations of ceftriaxone were 151 and 286 mg/L following bolus intravenous administration of 0.5 and 1.5g, respectively, and 82, 151 and 257 mg/ L after 30-minute infusions of 0.5, 1 and 2g, respectively. Due to saturable plasma protein binding the plasma concentration and the area under the plasma concentration-time curve (AUC) of total ceftriaxone increased less than dose-proportionally after intravenous doses greater than 1g. However, the peak free (unbound) plasma concentration increased disproportionally, thus supporting once daily administration of ceftriaxone in large doses rather than the same daily dose as divided smaller doses. Mean peak plasma ceftriaxone concentrations after intramuscular injection were around one-half those after intravenous administration of the same dose, and bioavailability was similar to that after intravenous injection. Accumulation of ceftriaxone in plasma was around 40% after 12-hourly intravenous injection, but only 8% when administered at 24-hour intervals.

The volume of distribution of total (bound plus unbound) ceftriaxone during the terminal elimination phase increased with increasing dose, but the volume of distribution of the free fraction remained relatively constant. Recent studies have confirmed that mean ceftriaxone concentrations inhibitory for most Gram-negative bacteria were present in many body fluids and tissues, and particularly in cerebrospinal fluid of patients with meningitis, 24 hours after 1 to 2g administered intravenously. Ceftriaxone is excreted in breast milk (around 3 to 4% of that in serum). High concentrations of ceftriaxone are attained in bile.

Ceftriaxone is excreted unchanged both by the kidney and by the liver, the proportion excreted by the kidney being higher in those aged less than 6 years than in older persons. Renal clearance of total ceftriaxone varied with both dose and time, but that of the free ceftriaxone fraction did not. Renal clearance of ceftriaxone is governed mainly by glomerular filtration. The elimination half-life of ceftriaxone was generally about 6 to 9 hours in healthy adult subjects, and was only slightly to moderately affected in the presence of decreased renal or hepatic function, although half-life was increased in neonates and in patients over 70 years. Mean systemic clearance of the free ceftriaxone fraction was decreased in neonates compared with that in young or middle-aged adults, indicating the immaturity of ceftriaxone clearance mechanisms. Only functionally anephric patients with markedly decreased non-renal clearance will require dose adjustments of ceftriaxone to avoid major drug accumulation. In patients undergoing chronic ambulatory peritoneal dialysis, plasma and dialysate concentrations above the MIC90 for most pathogens are achieved and sustained over 24 hours after either intravenous or intraperitoneal administration.

Therapeutic Trials

Since ceftriaxone was first reviewed in the Journal, therapeutic studies have concentrated on comparing the efficacy of once daily ceftriaxone 1 to 2g with that of other antibiotics given in standard therapeutic regimens in severe or complicated urinary tract infections, lower respiratory tract infections, uncomplicated gonorrhoea, gonococcal ophthalmia neonatorum, bacterial meningitis, bacteraemia, connective tissue infections, infections in neutropenic patients, primary syphilis, typhoid fever, shigellosis, pelvic inflammatory disease, generalised peritonitis and Lyme disease. Ceftriaxone has also been extensively studied as a prophylactic antibiotic for use in patients undergoing various types of surgery.

Ceftriaxone 1 or 2g once daily intravenously or intramuscularly for a mean period of 5 to 7 days was not significantly different in efficacy from ceftizoxime 2g twice daily or cefoxitin 2g twice daily intravenously in severe or complicated urinary tract infections, but was significantly better than cefotaxime 1 to 2g twice daily, cefuroxime 0.75g 3 times daily, cefazolin 1g 3 times daily or netilmicin 2 mg/kg twice daily intravenously or intramuscularly in acute and complicated urinary tract infections.

Ceftriaxone alone administered once or twice daily was effective in eradicating 100% of S. pneumoniae, H. influenzae, S. aureus and Proteus mirabilis and about 50% of the small numbers of isolates of P. aeruginosa and Serratia species from patients with pneumonia. Ceftriaxone 1 to 2g once daily was similar in clinical efficacy to cefamandole 1.5g 6-hourly, cefonicid 1g once daily, amoxycillin 1g 4 times daily intravenously, and amoxycillin 50 mg/kg daily orally plus tobramycin 5 mg/kg/day intramuscularly in patients with acute pneumonia, and with cefotaxime 2g twice daily in patients with either acute pneumonia or acute exacerbation of chronic pneumonia.

In earlier studies bacteriological results were reported for only a few patients with septicaemia/bacteraemia who were treated with ceftriaxone, but ceftriaxone-sensitive Enterobacteriaceae (Escherichia coli, P. mirabilis, Serratia marcescens, Klebsiella pneumoniae, Enterobacter aerogenes and Citrobacter species) were isolated most frequently and all of the isolated strains were eradicated. Combined clinical and bacteriological ‘cure’ (definition varied) was reported in 43 to 91% of patients. However, the cure rate varied with the site of origin of the bacteraemia/septicaemia. Satisfactory clinical responses were obtained in over 88% of patients treated with ceftriaxone (usual dosage 2 g/day as 1 or 2 administrations daily) often in conjunction with surgical procedures for skin, soft tissue, bone or joint infections caused by Gram-positive aerobes (e.g. Staphylococcus aureus), Gram-negative aerobes and, in a few cases, anaerobes. With once daily ceftriaxone, the few non-comparative studies conducted in small numbers of patients with bacteraemia/ septicaemia, bone and joint infections or skin and soft tissue infections have reported satisfactory clinical and/or bacteriological results in 80 to 100% of patients.

Uncomplicated anorectal or urethral gonorrhoea in males and in females, and cervical gonorrhoea in females has been cured in 92 to 100% of patients treated with a single dose of ceftriaxone 0.125 to 0.5g intramuscularly and in 92 to 100% treated with spectinomycin 2g, procaine penicillin 3g plus benzylpenicillin 0.6g, enoxacin 0.4g or procaine penicillin plus probenecid lg. In patients with pharyngeal gonorrhoea, ceftriaxone has been significantly more effective than spectinomycin (cure rates of 90 to 94% vs 43 to 50%).

Infections of the lower respiratory tract or urinary tract, and bacteraemia in non-neutropenic cancer patients, responded similarly to ceftriaxone (2g once or twice daily), cefoperazone (2g 8-hourly) or ceftizoxime (2g 8-hourly).

In several recent studies in neutropenic cancer patients with confirmed or suspected secondary infection, ceftriaxone has proven particularly effective. At doses of 2 to 3g (or 50 mg/kg in children) once-daily ceftriaxone (sometimes in combination with an aminoglycoside) was associated with a successful clinical outcome in 62.5 to 94% of patients, and was invariably at least as effective as various other parenteral antibacterial regimens.

A high degree of efficacy (almost 100%) against bacterial meningitis in infants and children was demonstrated by ceftriaxone 50 to 100 mg/kg daily given intravenously as a single dose or (more often) twice daily, and ceftriaxone was of similar efficacy to ampicillin 50 mg/kg 4- to 6-hourly plus chloramphenicol 25 mg/kg 6-hourly, or cefuroxime 240 mg/kg daily in 4 divided doses.

Several recent comparative studies in relatively large numbers of patients have demonstrated the efficacy of a single preoperative dose of ceftriaxone in preventing postoperative infections. Thus, ceftriaxone 1 or 2g usually administered intravenously at induction of anaesthesia was as effective as one preoperative dose and several postoperative doses of cefazolin or cefuroxime in cardiac and vascular surgery, and as effective as cefazolin or cefotaxime in gynaecological and obstetric surgery. Ceftriaxone 2g plus metronidazole 1.5g given as a single dose before colorectal surgery was more effective in preventing infection than a single dose of gentamicin 120mg plus metronidazole 1.5g or neomycin 1g plus erythromycin 1g orally 3 times daily the day before operation. A single dose of ceftriaxone 1g intravenously was more effective than placebo in preventing wound infection after elective gallbladder surgery. There was no significant difference in prophylactic efficacy between ceftriaxone 2g (single dose) and cefotaxime 1.5g preoperatively plus two subsequent doses of 0.75g in patients who underwent endoscopic prostatectomy, or between a single 1 or 2g dose of ceftriaxone compared with cefotaxime and cefotiam 2g twice daily for 1 or 5 days in preventing infection following maxillofacial surgery.

Adverse Effects

Ceftriaxone has generally been well tolerated by adults and children following intravenous and intramuscular injection. The overall incidence of adverse events is about 7 to 8%, with the most commonly occurring types being typical of the parenteral cephalosporins — gastrointestinal disturbances (about 3%, mostly diarrhoea, nausea and/or vomiting), dermatological reactions (1 to 2%) and reactions at the injection site such as phlebitis and pain on intramuscular injection. During ceftriaxone therapy overgrowth with Candida albicans has occasionally been reported while isolation of Clostridium difficile or its toxin has rarely occurred. Variations in laboratory test results, including transient eosinophilia and elevations of renal and liver function tests, occur in about 4% of patients, but symptomatic drug-related nephrotoxicity or hepatotoxicity have not been reported.

Side effects and laboratory abnormalities severe enough to warrant treatment withdrawal occurred in 0.6 to 1.8% of patients.

Dosage and Administration

Ceftriaxone can be administered intravenously or intramuscularly. For adults the recommended dosage is 1 to 2g once daily (or in equally divided doses twice a day). In severe infections and in cases in which the pathogens are only moderately sensitive the daily dose may be increased but should not exceed 4g. For the treatment of uncomplicated gonorrhoea a single intramuscular dose of 250mg is recommended, and for prevention of surgical infection the recommended dose is a single dose of 1g 0.5 to 2 hours before surgery. In infants and young children the recommended daily dose is 50 to 75 mg/kg for infections other than meningitis, for which the dosage is 100 mg/kg given in divided doses every 12 hours (not to exceed 4g).

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Various sections of the manuscript reviewed by: V. Fainstein, University of Texas Cancer Institute, Houston, Texas, USA; G. Gialdrani Grassi, Facolta di Medicina e Chirurgia, Universitadi Pavia, Pavia, Italy; D. Greenwood, Department of Microbiology, Queens Medical Centre, Nottingham, England; R.- M. Harnoss, Universitätsklinikum Steglitz, Freie Universität, Berlin, West Germany; R.N. Jones, Clinical Microbiology Institute, Tualatin, Oregon, USA; F.N. Judson, Department of Health and Hospitals, Disease Control Service, Denver, Colorado, USA; Y. Kawada, Department of Urology, Gifu University School of Medicine, Gifu-shi, Japan; S. Lang, Department of Clinical Microbiology, Middlemore Hospital, Auckland, New Zealand; J. de Louvois, Department of Microbiology, Queen Charlottes Hospital for Women, London, England; J. Modai, Faculté de Medicine, L’Hôpital Saint-Louis, Paris, France; H.C. Neu, Department of Medicine, College of Physicians and Surgeons of Columbia University, New York, USA; S.R. Norrby, Department of Infectious Diseases, University Hospital of Lund, Lund, Sweden; A.D. Russell, The Welsh School of Pharmacy, University of Wales Institute of Science and Technology, Cardiff, Wales; J. Shimada, Department of Medicine, Jikei University School of Medicine, Tokyo, Japan; R. Wise, Department of Medical Microbiology, Dudley Road Hospital, Birmingham, England.

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Brogden, R.N., Ward, A. Ceftriaxone. Drugs 35, 604–645 (1988). https://doi.org/10.2165/00003495-198835060-00002

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