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PubMed1991

Comparative bioavailability study of cefixime administered as tablets or aqueous solution.

The relative bioavailability of cefixime was studied in 24 healthy male volunteers, with each subject receiving a single 400mg dose of cefixime administered as an aqueous solution, a 400mg tablet and two 200mg tablets, in a randomised crossover sequence. Serum and urine samples were analysed using high-performance liquid chromatography. Peak cefixime levels were achieved 3 hours after administration of the solution vs 4 hours for the 2 tablet formulations; however, the extent of absorption was only slightly improved with the solution (by 14 and 7% compared with the 1 x 400 and 2 x 200mg tablets, respectively). The 400mg and 2 x 200mg tablets were found to be bioequivalent. The pharmacokinetic profile of the 400mg cefixime tablet (mean maximum plasma concentrations of 4.4 mg/L at 4 hours, area under the concentration-time curve of 34.4 mg/L.h, and apparent terminal elimination half-life of 3.7 hours) supports the clinical evaluation of a 400mg once-daily dosage regimen for cefixime.

Adult↗
PubMed1991

Efficacy and tolerability of cefixime in otitis media. A multicentre study in over 25,000 children.

A large scale multicentre clinical study was undertaken to assess the efficacy and tolerability of cefixime in the treatment of acute otitis media in children. A total of 25,863 evaluable children with acute otitis media received cefixime 8 mg/kg once daily for at least 10 days. At the end of treatment, 86% of patients were considered to be either cured or improved. These results are consistent with those achieved with cefixime in controlled clinical trials. Adverse effects were reported in 11.5% of patients, but were judged to be related to cefixime therapy in only 9.4% of patients. The results of this study demonstrate that cefixime is an effective and well tolerated treatment for acute otitis media in children.

Acute Disease↗
PubMedDate not supplied

Treatment of sinus empyema in adults. A coordinated Nordic multicenter trial of cefixime vs. cefaclor.

In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral reaspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p less than 0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p less than 0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.

Cefaclor↗
PubMed2001

Comparative study of ceftibuten and cefixime in the treatment of complicated urinary tract infections.

Between August 1996 and May 1998, a total of 62 patients who had complicated urinary tract infections treated at the Taipei Veterans General Hospital were enrolled into this study. This prospective, randomized, open-labeled trial aimed at comparing the efficacy and safety of ceftibuten and cefixime, prescribed each at a dose of 200 mg twice daily, in treating complicated urinary tract infection. Seventeen patients were later excluded from the analysis because of resistant pathogens (7 patients), uncomplicated urinary tract infection (6), initial culture negative for bacteria (3), and infective endocarditis (1). The remaining 45 patients were categorized into ceftibuten (n=23; mean age, 71.3 years) and cefixime (n=22; mean age, 62.8 years) treatment groups. No significant difference in demographic data and clinical characteristics was found between the 2 groups. The clinical efficacy rate (78.3% vs 77.3%, p=0.9) and bacteriological eradication rate (52.2% vs 63.6%, p=0.08) were similar between the ceftibuten and the cefixime group. Adverse effects caused by ceftibuten treatment included diarrhea and slight elevation of the serum level of liver transaminase in 2 (6.5%) patients. Those caused by cefixime treatment included slight elevation of serum level of liver transaminase in 2 (6.5%) patients and skin rash in 1 (3.2%) patient. All of these adverse effects resolved quickly after the regimen had been completed, and no patient discontinued the regimen because of the adverse effects. The results suggest that oral administration of ceftibuten 200 mg twice daily is as effective and safe as oral administration of cefixime 200 mg twice daily in the treatment of complicated urinary tract infections.

Adult↗
PubMed1992

[Alteration of bacteria induced by subinhibitory concentrations of cefixime: consequences on bactericidal activity of human polynuclear neutrophils].

Subinhibitory concentrations of most parenteral cephalosporins have been reported to alter bacterial infectivity and, in particular, to increase the susceptibility of altered bacteria to the killing effects of polymorphonuclear neutrophils (PMN). Few data on this issue are available for oral cephalosporins. This study investigated the effects of sub-MIC concentrations of the new oral cephalosporin cefixime on two bacterial targets, i.e., S. aureus 209P (MIC 20 mg/l) and E. coli K12 (MIC 0.15 mg/l). After overnight incubation (18 hours) with 10 or 5 mg/l cefixime, susceptibility of S. aureus to the killing effects of PMNs was increased two-fold as compared with control organisms and susceptibility to the O2-independent PMN bactericidal system (PMN extract) was also increased. In contrast, the susceptibility of E. coli to PMN and to cell-free bactericidal systems was identical for cefixime-exposed strains (0.1 and 0.05 mg/l) and for unexposed controls. However, cefixime-exposed E. coli were filamentous, suggesting that bactericidal efficacy in terms of the bacterial mass eliminated was enhanced in exposed strains. These data show that low levels of cefixime are capable of producing major alterations in susceptible and resistant bacteria and of increasing their susceptibility to PMN. These effects may be relevant in vivo, in particular when low concentrations of antibiotics persist over long periods in infected sites.

Anti-Infective Agents, Urinary↗
PubMed1992

[Effect of the administration of cefixime on aerobic fecal flora in children].

The ecological effect of cefixime on aerobic fecal flora was evaluated in 6 children aged 2 to 5 years given oral cefixime (8 mg/kg/day in two divided doses) for five days. Serial dilutions of stools recovered at baseline (D0), 2 and 5 days after initiation of therapy (D2 and D5) and two days after completion of therapy (DC + 2) were cultured on selective media. Colonies of Enterobacteriaceae, group D streptococci, staphylococci, and Candida were counted. A moderate but significant (p less than 0.01) decrease in the Enterobacteriaceae count was seen, with a fall from 8 log 10 (4.8 to 9.4) on D0 to 6.4 (3.6-9) on D2, 6 (4.6-7.2) on D5 and 4.7 (2-8.2) on DC + 2. No cefixime-resistant Entrobacteriaceae or Pseudomonas strains were evidenced. A slight, non significant decrease in group D streptococci counts was found, with values of 7.1, 7.1, 5.8, and 8.3 log 10 at the successive time points. All children exhibited fecal staphylococcal strains which were all coagulase-negative and which did not undergo noticeable quantitative changes (mean successive values were 2.5, 1.8, 3.5, and 3.8 log 10). Candida were found in four children and also changed little over time (mean successive values: 2, 1.7, 2, and 2.6 log 10). In sum, oral administration of cefixime was associated with a modest decrease in the number of Enterobacteriaceae, with no development of resistance to cefixime.

Administration, Oral↗
PubMedDate not supplied

Oral cefixime versus intramuscular ceftriaxone in patients with uncomplicated gonococcal infections.

A randomized trial was conducted to compare cefixime (400 mg or 800 mg single oral dose) with ceftriaxone (250 mg single intramuscular dose) in terms of efficacy and safety for the treatment of uncomplicated Neisseria gonorrhoeae urethritis or cervicitis. Of 75 men and 150 women screened, 187 had positive culture results for N. gonorrhoeae. The course of treatment was evaluable in 155 cases (59 men, 96 women). Bacteriologic eradication was evident in 97% (105 out of 108) of the patients treated with cefixime and in 100% (47 out of 47) of the patients treated with ceftriaxone. N. gonorrhoeae was eliminated at 98% (143 out of 146) and 100% (72 out of 72) of the infection sites in the respective treatment groups. Of the 187 isolates, 8 were penicillinase-producing (PPNG) and 20 had high-level tetracycline resistance (TRNG). The cefixime and ceftriaxone MIC90 for all 187 study isolates was 0.008 micrograms/ml. The adverse clinical experiences reported by the patients treated with cefixime (10%) were self-limiting; no adverse experiences occurred in the patients treated with ceftriaxone. Cefixime was as well tolerated and efficacious as ceftriaxone in the treatment of the patients with uncomplicated N. gonorrhoeae urethritis or cervicitis reported here.

Administration, Oral↗
PubMed1991

Cefixime shows good effects on group A and group B beta-haemolytic streptococci.

There is continued interest in the development of oral beta-lactam compounds, which can be used clinically to treat various bacterial infections, particularly those caused by beta-haemolytic streptococci. Cefixime is a new orally active cephalosporin, with a broad spectrum of antibacterial activity, including Enterobacteriaceae, Haemophilus influenzae, Branhamella catarrhalis, Streptococcus pneumoniae and Streptococcus pyogenes. Cefixime is highly resistant to hydrolysis by most beta-lactamases. In this study the authors examined the effects of this molecule on Group A and Group B beta-haemolytic streptococci, recently isolated from clinical specimens in the authors' laboratory. MICs and the growth curves of 36 strains of Group A streptococci and the effects of sub-MICs on buccal cell adhesion were evaluated. The results show that concerning the sub-MIC cefixime effect on streptococci adherence, the treatment led to a decrease in adherence to the cells of the strains studied. Moreover cefixime showed good activity with 86.1% of the strains with MIC less than or equal to 0.5 microgram/ml, and the growth curves demonstrated that the molecule possesses a bactericidal effect after 3 h. Concerning Group B streptococci, 70.3% of the strains showed a MIC less than or equal to 2 micrograms/ml. In conclusion cefixime demonstrates good activity on beta-haemolytic streptococci, particularly those of Group A.

Anti-Infective Agents, Urinary↗
PubMed1989

[Pharmacokinetic properties of cefixime].

After a 200 mg intravenous or oral dose, the absolute bioavailability of cefixime, evaluated by comparison of areas under the serum concentration-time curve values, is 50 per cent. Because food has no effect on peak serum concentrations or on the extent of drug absorption, cefixime can be taken with or without meals. Protein binding is 70 per cent. Cefixime is cleared, mainly unchanged, partly by the liver (60 per cent) and partly by the kidneys (40 per cent). The elimination half-life varies between 3 and 4 hours. Plasma concentrations increase linearly but not proportionally to doses. No significant accumulation was observed after repeated administration in young and elderly subjects. The pharmacokinetic profile of cefixime is significantly altered in patients with marked renal impairment (creatinine clearance less than 20 ml/min), and in such cases dosage should be reduced from 400 to 200 mg/day. Haemodialysis or peritoneal dialysis do not remove significant amounts of the drug from the body. In cirrhotic patients, no dosage adjustment is needed, although the elimination half-life is increased twofold (congruent to 6.5 hours). The extravascular and tissue diffusion of cefixime is satisfactory in those areas where the organisms need to be eradicated.

Administration, Oral↗
PubMed1989

[Pulmonary diffusion of cefixime in man].

We measured the concentrations of cefixime in the human lung in vivo in order to evaluate indirectly the effectiveness of this antibiotic in the treatment of pulmonary infections. Twenty-three patients undergoing lung surgery entered the study and received cefixime either 200 mg 12-hourly (4 times) or 400 mg every 24 hours (twice). Blood samples and tissue specimens were collected simultaneously during surgery 4 or 8 hours after the last dose. Cefixime concentrations were measured by HPLC. The penetration of cefixime in both normal and neoplastic lung tissue was significant. Four or 8 hours after a 200 or 400 mg oral dose, lung concentrations were higher than the MIC90 values for sensitive strains and therefore consistent with effective therapeutic activity. The pharmacokinetics of cefixime in blood and in lung tissue suggest that pulmonary infections could be treated with a 400 mg dose once a day.

Cefixime↗
PubMed1989

[Tonsillar diffusion of cefixime in children].

Cefixime was assayed by a microbiological method in the tonsils of 21 children (mean age 59 months). Tonsillectomy was performed 5 hours after a third dose of 4 mg/kg administered 12-hourly. Plasma cefixime levels were evaluated 10 hours after the second dose with a mean value of 0.84 mg/l (range: 0 to 1.35) and again after a third dose during amygdalectomy with a mean value of 1.24 mg/l (range: 0.1 to 3.9). Cefixime concentrations were 0.74 micrograms/g in the right tonsils and 0.53 micrograms/g in the left tonsils. The antibiotics could not be detected in both tonsils in 6 children and in one of the two tonsils in 11 children. The tissue penetration of cefixime in tonsils therefore was about 1 micrograms/g in those cases where cefixime was detectable. As with other beta-lactam antibiotics, this penetration is not regular, being dependent on the degree of tonsillar fibrosis inhibitin their diffusion.

Biological Transport↗
PubMed1989

[Efficacy and tolerability of cefixime in international and French studies].

Cefixime, the first oral third generation cephalosporin, was administered to 2,832 patients in the USA, UK, FRG and France. 478/1063 patients were treated for urinary tract infections (upper or lower UTI) with 200 mg cefixime bid; clinical cure was obtained in 92 and 96 per cent of upper and lower UTI respectively, and bacteriological cure in 97.5 and 89 per cent of the cases; among 142 patients with a 1 month follow-up, no relapse or reinfection was observed in 78 per cent of cases. Of 521 patients treated for lower respiratory tract infection, 355 received 200 mg cefixime bid and 166 received a single daily dose of 400 mg. Clinical cure was obtained in 88 per cent and 93 per cent patients with pneumonia or bronchitis respectively, with bacteriological cure in 93.2 and 93.8 per cent. Among ENT infections, the most interesting study was in the treatment of sinusitis and otitis. Good clinical results were shown in nearly 95 per cent of cases, with bacteriological cure in more than 90 per cent. The safety studies demonstrated a global 6.6 per cent incidence of undesirable effect. These manifestations were mild and reversible, consisting of abdominal discomfort and minor diarrhea in most cases. The overall effectiveness of cefixime appears to be similar to that of established compounds as far as susceptible pathogens are concerned. However, in clinical trials, cefixime seemed to be effective on isolated bacteria unresponsive to conventional antibiotics.

Cefixime↗
PubMed1989

Cefixime versus amoxicillin/clavulanic acid in lower respiratory tract infections.

Sixty patients with lower respiratory tract infections, mainly acute bronchitis were treated for 14 days with either cefixime 200 mg twice daily (plus placebo once daily) or amoxicillin/clavulanic acid 500 mg/125 mg thrice daily in a double-blind manner. The sputum cultures indicated that all isolated pathogens (notably Hemophilus species, S. pneumoniae and B. catarrhalis, including the beta-lactamase producing species) were sensitive to cefixime, with the exception of Pseudomonas species. The bacteriological eradication rates were 54% and 52% for cefixime and amoxicillin/clavulanic acid, respectively. The positive clinical response (cured or improved) was 71% for the cefixime treated group and 74% in the amoxicillin/clavulanic acid group. There were no side effects and no significant adverse laboratory changes in both groups. The results indicate that cefixime twice daily is comparable in safety and efficacy with amoxicillin/clavulanic acid, thrice daily in acute bronchitis.

Adult↗
PubMed1989

A general practice comparative study of a new third-generation oral cephalosporin, cefixime, with amoxycillin in the treatment of acute paediatric otitis media.

A total of 325 eligible paediatric patients were entered into an open, randomised, multicentre general practice study to assess the comparative efficacy of a new third-generation oral cephalosporin, cefixime, with respect to that of amoxycillin in the treatment of acute otitis media. The dose of cefixime was 100 mg once daily (six months to five years), 200 mg once daily (five to 10 years) and 300 mg once daily (10 to 16 years). The dose of amoxycillin was as currently used by the participating general practitioners: 62.5 mg tds (six months to one year), 125 mg tds (one to seven years) and 250 mg tds (seven to 16 years). Both were in the form of an oral suspension. The two groups (160 patients on cefixime and 165 on amoxycillin) were comparable at study entry with respect to all parameters assessed. Overall there was a 95 per cent favourable clinical response seen in both groups (95 per cent confidence limits: 92 and 98 per cent respectively). Adverse events were comparable in both groups, except that there were more gastrointestinal side effects seen with cefixime (13 per cent) compared with amoxycillin (4 per cent), but only three patients in each group had to be withdrawn because of side effects. These results demonstrate that cefixime given once daily is a safe and effective alternative to amoxycillin in the treatment of acute otitis media in children, and also has the advantage of less frequent dosing.

Acute Disease↗
PubMedDate not supplied

Comparative pharmacokinetics of oral ceftibuten, cefixime, cefaclor, and cefuroxime axetil in healthy volunteers.

STUDY OBJECTIVE: To compare the pharmacokinetics of ceftibuten, cefixime, ceturoxime axetil, and cefaclor after oral administration. DESIGN: Randomized, four-period, crossover study. SETTING: Hospital-based clinical research center. SUBJECTS: Healthy adult men and women volunteers. INTERVENTIONS: Single 400-mg doses of cefixime and ceftibuten, and 500-mg doses of cefuroxime axetil and cefaclor. MEASUREMENTS AND MAIN RESULTS: Serum concentrations were determined by high-performance liquid chromatography methods. The mean oral clearances of cefixime, cefuroxime axetil, and cefaclor were similar, ranging from 20.4-27.0 L/hour; clearance of ceftibuten was approximately 4-fold less, 5.45 L/hour. The serum half-lives of ceftibuten (2.35 hrs) and cefixime (2.38 hrs) were prolonged compared with those of cefuroxime axetil (1.30 hrs) and cefaclor (0.693 hr). These agents also differed in terms of time to maximum concentration, time to peak plasma level, area under the curve, and apparent volume of distribution, the last reflecting differences in biovailability. CONCLUSION: Ceftibuten had a relatively high time to maximum concentration and long half-life, resulting in a 3.5-fold higher area under the curve than cefixime, cefuroxime axetil, and cefaclor. These pharmacokinetic data can be used as a basis to compare the four oral cephalosporins; however, comparative susceptibility data must also be considered.

Administration, Oral↗
PubMed1998

A comparative study of cefixime and chloramphenicol in children with typhoid fever.

We compared cefixime with chloramphenicol in a randomized trial for treatment of children with culture positive typhoid fever. Twenty children were given cefixime 10 mg/kg/day orally and twenty received chloramphenicol 50 mg/kg/day orally. On entry in the study, the clinical characteristics of the two groups were comparable. Duration of therapy was 14 days. Clinical cure was observed in 18 (90%) patients treated with cefixime and 9 (45%) treated with chloramphenical. Out of the 11 patients who did not respond to chloramphenicol, 10 were switched over to cefixime and all of them were cured. Over all 28 cases out of 30 (93.3%) P = 0.0049 were cured by cefixime.

Anti-Bacterial Agents↗
PubMed1998

A comparative study of cefixime and chloramphenicol in children with typhoid fever.

We compared cefixime with chloramphenicol in a trial for treatment of children with culture positive typhoid fever. Twenty children were given cefixime 10 mg/kg/day orally for 14 days and twenty received chloramphenicol 50 mg/kg/day orally for 14 days. On entry the clinical characteristics of the two groups were comparable. Clinical cure was observed in 18 (90%) patients treated with cefixime and 9 (45%) treated with chloramphenicol. Of 11 patients who did not respond to chloramphenicol, 10 were switched over to cefixime and all were cured. Overall 28 out of 30 cases (93.3%) were cured by cefixime.

Anti-Bacterial Agents↗
PubMedDate not supplied

Antibacterial activity of cefpodoxime in comparison with cefixime, cefdinir, cefetamet, ceftibuten, loracarbef, cefprozil, BAY 3522, cefuroxime, cefaclor and cefadroxil.

The new oral cephalosporins cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten demonstrate enhanced activity against Enterobacteriaceae susceptible to the established compounds as well (e.g. cefuroxime, cefaclor, cefadroxil). In addition, cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten include in their spectrum species hitherto resistant to oral cephalosporins (Proteus vulgaris, Providencia spp., Yersinia enterocolitica). Besides, the majority of these compounds demonstrate relevant activity (MIC50 equal to or below 2 mg/l) against Enterobacter spp., Citrobacter freundii, Serratia spp. and Morganella morganii. Ceftibuten is the most potent oral cephalosporin against most of the Enterobacteriaceae. Non-fermentative bacilli (Acinetobacter spp., Pseudomonas spp.) remain completely resistant to oral cephalosporins (except some Acinetobacter species against cefdinir and Pseudomonas cepacia against ceftibuten). Antistaphylococcal activity for oral cephalosporins is highest for cefdinir followed by BAY 3522, cefprozil, cefuroxime and cefpodoxime. Loracarbef, cefaclor and cefadroxil are about equally active, while the other compounds are only weakly active (cefixime) or inactive (cefetamet, ceftibuten). Enterococci are insensitive to new generation oral cephalosporins as they have been to established compounds. The most active oral cephalosporins against hemolytic streptococci are cefdinir and cefprozil. Streptococcus pneumoniae, Streptococcus milleri and Streptococcus mitior are most susceptible to cefpodoxime, cefdinir, cefuroxime and BAY 3522. Penicillin resistant pneumococci have to be regarded as resistant to all oral cephalosporins. Fastidious pathogens like Haemophilus spp., Moraxella catarrhalis and Neisseria gonorrhoeae are more susceptible to cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten than to the other oral cephalosporins. The activity of oral cephalosporins is only weak against Listeria spp., Helicobacter pylori and anaerobic pathogens (except BAY 3522). Bordetella pertussis remains resistant to all absorbable cephalosporins. Progress in antibacterial activity of oral cephalosporins was mainly achieved by cefpodoxime, cefixime, cefdinir, cefetamet and ceftibuten against Enterobacteriaceae and the fastidious pathogens and against staphylococci and the nonenterococcal streptococci by cefdinir, BAY 3522, cefprozil and cefpodoxime.

Bacteria↗