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PubMed1989

[In vitro comparative bactericidal effect of cefotaxime and cefixime in a kinetic model].

The bactericidal activity of cefotaxime against Escherichia coli, Klebsiella pneumoniae and Serratia marcescens, was compared with that of cefixime in an in vitro model simulating the human pharmacokinetics of these antibiotics. Kinetic parameters in this model were T1/2 = 1.3 h and Cmax = 45 mg/l for cefotaxime; T1/2 = 3.5 h and Cmax = 5 or 3.5 mg/l for cefixime. These parameters mimicked those obtained after a 1 g intravenous infusion of cefotaxime and an oral uptake of 0.4 or 0.2 g of cefixime, respectively. Both antibiotics demonstrated a strong bactericidal activity. Against Escherichia coli, the bactericidal effect of cefotaxime was slightly more rapid and more prolonged than that of cefixime: -5 log10 CFU/ml over 4 h vs -3 log10 CFU/ml over 8 h respectively. Against Klebsiella pneumoniae and Serratia marcescens, both drugs exhibited similar bactericidal activity despite different dosages and routes of administration: -2 to -3 log10 CFU/ml over 4 h.

Cefixime↗
PubMed1989

[Effect of hepatic failure upon the pharmacokinetics of cefixime].

Modifications of cefixime kinetics due to severe impairment of liver function were determined in 9 cirrhotic patients. Cefixime was administered as a single dose of 200 mg and levels were measured by HPLC. Maximum serum concentrations and area-under-the-curves of serum concentrations were not modified. The time for maximum serum concentration was delayed and the cefixime half-life in serum was prolonged, as a reflect of increased volume of distribution resulting from ascites and hypoalbuminemia. Renal clearance increased in these patients, possibly because of reduced extra-renal clearance. No metabolite was detected in serum or urine. Modifications of cefixime kinetics resulting from impaired hepatic function were modest and did not require specific dosage adjustment.

Adult↗
PubMed1987

Cefixime: spectrum of antibacterial activity against 16,016 clinical isolates.

The spectrum of antibacterial activity of cefixime was defined by reviewing data from two multicenter studies and three independent studies that we performed within the past 3 years. Microdilution tests were performed with 16,016 bacterial isolates. An isolate was considered susceptible to cefixime if the minimal inhibitory concentration was less than or equal to 1.0 microgram/ml and resistant if the minimal inhibitory concentration was greater than or equal to 4.0 micrograms/ml. Cefixime was effective against the Enterobacteriaceae (87.7% susceptible to 1.0 microgram/ml) as well as against pathogenic Neisseria spp. (including penicillin-resistant gonococci), Haemophilus influenzae (including ampicillin-resistant strains), penicillin-susceptible Streptococcus pneumoniae and other Streptococcus species (minimal concentration inhibiting 90% of organisms less than or equal to 0.25 micrograms/ml). Species resistant to cefixime included penicillin-resistant pneumococci, Staphylococcus spp., Enterococcus spp., Listeria spp., Acinetobacter spp. and Pseudomonas spp.

Bacteria↗
PubMed1995

Clinical pharmacologic aspects of cefixime in dogs.

The minimal inhibitory concentration (MIC) of cefixime, a new third-generation orally administered caphalosporin, was determined for reference and clinical isolates from dogs. The MIC of the drug for all but 1 of the 18 Enterobacteriaceae isolates tested, 1 Pasteurella canis, 1 Rhodococcus equi, 1 Streptococcus canis, and 1 Streptococcus group G isolate, was less than 1.0 microgram/ml. The MIC for 9 Staphylococcus intermedius isolates ranged from 1.56 to 6.25 micrograms/ml and, for 8 Sta aureus isolates, the MIC values ranged from 1.56 to 12.5 micrograms/ml. Pseudomonas aeruginosa, Actinomyces sp, and a single Bordetella bronchiseptica isolate were considered resistant to cefixime. Cefixime was administered orally in 2 phases at a standard dosage of 5 mg/kg of body weight to clinically normal adult male and female dogs. In the first phase, the drug was given once as a capsule and once as a suspension. In the second phase, it was administered once per day for 6 consecutive days in capsule form. Serum drug concentration was determined by use of a microbiological assay, and the following kinetic values were estimated for each dog: area under the concentration-time curve, peak serum drug concentration (Cmax), time of Cmax, absorption half-life, and elimination half-life (t1/2el). The kinetic profile of the drug in serum after oral administration of a single dose of cefixime was similar, with mean Cmax values of 3.36 and 4.76 micrograms/ml after treatment with the capsule and suspension, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMedDate not supplied

[Kinetics of cefixime biliary clearance in cholecystectomized patients].

Cefixime is an orally administered cephalosporin with physicochemical properties able to account for a possibly significant biliary excretion. In addition, over 50% of total clearance of the drug has been shown to operate through extra renal pathways in healthy volunteers. The aim of the study was to quantify and to delineate the kinetics of cefixime biliary elimination in ten patients provided with external drainage. Following a single 200 mg oral dose of cefixime, biliary clearance of the drug appears to vary from 0.85 to 27.3 ml/min. Contribution of the latter to the apparent total clearance is relatively low since ranging from 0.8 to 18.6% (mean 5%). Additionally, biliary clearance kinetics of the drug proves non linear and well described according to a sigmoidal model. On account of these results, and given the dianionic charge of the molecule as well as the absence of any metabolite reported so far, an intrahepatic binding and accumulating process, mediated by ligandin, seems to underlie the hepatobiliary excretion of cefixime, as previously reported for other anionic beta-lactam antibiotics.

Adult↗
PubMed1997

In vitro activity of cefixime versus ceftizoxime against Salmonella typhi.

Emergence of multi-resistant strains of Salmonella typhi is a major problem in treatment of typhoid fever and requires an excessive hospitalization period. Therefore, the present study was carried out to estimate the degree of the resistance of S. typhi strains to various antibiotics such as cefixime. Fifty two strains of Salmonella typhi isolated from patients with typhoid fever and their sensitivity to various antibiotics was determined. MICs of cefixime and chloramphenicol were also determined according to comitee de l'antibiogramme français. Results indicated that 41.9%, 33.9%, 38.7%, 58.1% and 1.6% of isolated strains were resistant to chloramphenicol, co-trimoxazole, ampicillin, tetracycline and gentamycin respectively. About one third (33.9%) of strains showed multiple resistance to the first four mentioned antibiotics. All strains were susceptible to ceftizoxime and cefixime (MICs 1 and less than 1 mcg/ml). It could be concluded that cefixime due to its effectiveness, oral administration and shorter courses of treatment could be the therapy of choice in cases of typhoid fever caused by multiple resistant strains especially when we have a shortage of hospital beds.

Anti-Bacterial Agents↗
PubMed1993

Efficacy of cefixime in the treatment of acute otitis media in children.

OBJECTIVE: To compare the efficacy of cefixime with amoxicillin in the treatment of acute otitis media in children. DESIGN: Randomized, nonblinded study. SETTING: General pediatric clinic at a university hospital in Texas. PARTICIPANTS: A volunteer sample of 201 children, aged 2 months through 6 years. INTERVENTIONS: A 10-day oral course of cefixime (8 mg/kg per day administered once daily) or amoxicillin (40 mg/kg per day administered in three divided doses [every 8 hours]). MEASUREMENTS/MAIN RESULTS: Tympanocentesis for bacterial culture was performed on all affected ears on enrollment and after 4 to 6 days of therapy. The patients were evaluated clinically 4 to 6 days after starting therapy, at the end of therapy, and 3 to 4 weeks after therapy was completed. Using Fisher's Exact Test, no significant difference was found between the two treatment groups for rate of clinical improvement or rate of eradication of Haemophilus influenzae and Streptococcus pneumoniae. However, combining the results from this study and two previously reported studies, cefixime was found to be more effective in eradication of H influenzae and less effective in eradication of S pneumoniae.

Acute Disease↗
PubMedDate not supplied

Phase I study of cefixime, a new oral cephalosporin.

The tolerance to and pharmacokinetics of cefixime, a new oral cephalosporin, were evaluated in healthy volunteers given the drug in single doses of 50, 100 and 200 mg and repeated doses of 200 mg bid for 14 days. In the repeated-dose study, there were mild and transient subjective symptoms such as soft stools, diarrhea, and anorexia, which disappeared without additional treatment during the dosing period. Slight increases in eosinophil and serum amylase levels were also observed. The serum concentrations of cefixime peaked at 0.71, 1.17, and 2.08 micrograms/mL on average, four to five hours after dosing with 50, 100, and 200 mg, respectively, and the half-lives were 2.54, 2.38, and 2.29 hours. Serum concentrations and urinary recoveries after dosing with 100 mg were little affected by food ingestion. There was no evidence of cefixime accumulation in the body by repeated dosing since mean serum concentrations and urinary recoveries were almost the same on the first, third, seventh, and 14th days of dosing.

Adult↗
PubMed1987

Degradation kinetics and mechanisms of a new cephalosporin, cefixime, in aqueous solution.

Hydrolysis of cefixime in buffer solutions (pH 1-9) at 25 degrees C and a constant ionic strength of 0.3 was investigated using ion-pair reversed-phase HPLC. Hydrolysis rates followed pseudo first-order kinetics; the rate of hydrolysis of cefixime was very slow at pH 4-7, slightly faster at lower pH, and quite rapid at higher pH. In the early stages of hydrolysis, six major degradation products were isolated and identified: a beta-lactam ring-opened product and a 7-epimer (basic conditions), three lactones derived from intramolecular cyclization between the 2-carboxyl and 3-vinyl groups (acidic conditions), and an aldehyde derivative involving a 7-acyl moiety (neutral conditions). Principal degradation pathways for cefixime were found to involve initial cleavage of the beta-lactam ring.

Cefixime↗
PubMed1990

[Pharmacokinetics of cefixime in volunteers and a literature comparison with the new ester prodrug cephalosporins].

The pharmacokinetic parameters of cefixime were determined in healthy volunteers following oral administration of 200 mg cefixime as tablet, syrup and dry suspension, respectively. All three galenic formulations showed reliable absorption. Mean peak plasma concentrations amounted to 2.4-3.4 mg/l and were reached after 3.3-3.5 h. Mean terminal half-lives were 2.9-3.1 h. The mean areas under the plasma concentration-time curves ranged between 18 and 26 mg/l.h; 18-24% of the dose administered were recovered unchanged in the urine. The best bioavailability was obtained with the dry suspension followed by the tablet and the syrup. With respect to the ester pro-drug cephalosporins, cefuroxime axetil, cefetamet pivoxyl and cefotiam hexetil, cefixime exhibits higher plasma half-life and area under the curve as well as, comparable absolute bioavailability but consistently lower urinary recovery which indicates higher non-renal clearance.

Administration, Oral↗
PubMed1995

Safety and efficacy of cefixime in treatment of respiratory tract infections in Germany.

From October, 1993 to August, 1994, a post-marketing surveillance study enrolled 9,568 adults and children treated for respiratory tract infections with cefixime in a daily dose of 400 mg or 8 mg/kg body weight, respectively. Twice daily dosage was preferred with adults (60.4%) and children (54.4%). Bronchitis (45.5%) and otitis media (48.0%) were the most frequent indications given for cefixime use in adults and children, respectively. Bacterial analysis was done in 5.4% of adults and in 6.5% of children. With a median therapy of 6 days, cure or improvement was reported in 98.7% of adult patients and in 98.0% of children. Symptoms rapidly improved in a majority of patients. Adverse events occurred in 1.12% of adult patients and 1.92% of children. In 96.7% of all cases the dry syrup was very well or well accepted by children. In conclusion, high efficacy and low incidence of side effects make cefixime a drug of choice for treatment of respiratory tract infections.

Adult↗
PubMed1995

Acute otitis media in children: a study of nasopharyngeal carriage of potential pathogens and therapeutic efficacy of cefixime and amoxicillin-clavulanate.

We conducted a large, multicenter, randomized, open-label study throughout France comparing the efficacy and safety of cefixime suspension (8 mg/kg/day, b.i.d., for 10 days) versus amoxicillin-clavulanate suspension (80 mg/kg/day, t.i.d., for 10 days) in 510 children (ages 6 to 36 months) with acute otitis media. The most frequent microorganisms colonizing the nasopharynx at the start of treatment were Streptococcus pneumoniae (51.5%), Haemophilus influenzae (45%) and Moraxella catarrhalis (30.2%). Rates of beta-lactamase positivity were 32.1% and 95.3% for H. influenzae and M. catarrhalis, respectively. Decreased susceptibility of S. pneumoniae to penicillin was found in 39.7% of isolates. Clinical efficacy was 87.8% (223/254) for cefixime and 87.0% (215/247) for amoxicillin-clavulanate. At the 5-week follow-up visit, relapse had occurred in 15.7% (31/197) of cefixime-treated patients and in 15.6% (32/205) of those treated with amoxicillin-clavulanate. We conclude that these two regimens are equally effective in acute otitis media in children.

Acute Disease↗
PubMed1990

In vitro susceptibility of Helicobacter pylori to the new oral cephalosporins cefpodoxime, ceftibuten and cefixime.

The in vitro activity against 30 Helicobacter pylori strains of three new third generation cephalosporins, cefpodoxime, ceftibuten and cefixime, which can be administered orally, was determined using an agar dilution technique under microaerophilic conditions. The MIC50 and MIC90 of cefpodoxime was 0.5 and 4.0 micrograms/ml respectively, of ceftibuten 2.0 and 8.0 micrograms/ml, and of cefixime 0.06 and 0.5 microgram/ml. All antibiotics showed good activity against Helicobacter pylori, cefixime having the highest activity of the three agents.

Administration, Oral↗
PubMed2005

Sensitive liquid chromatography-tandem mass spectrometry method for the determination of cefixime in human plasma: application to a pharmacokinetic study.

A sensitive and selective liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method was developed to determine cefixime ((6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-(carboxymethoxyimino)acetamido]-8-oxo-3-vinyl-5-thia-1-azabicyclo-[4,2,0]-oct-2-ene-2-carboxylic acid) in human plasma. After a simple protein precipitation using acetonitrile, the post-treatment samples were analyzed on a C(8) column interfaced with a triple quadrupole tandem mass spectrometer. Positive electrospray ionization was employed as the ionization source. The mobile phase consisted of acetonitrile-water-formic acid (40:60:0.5, v/v/v). The analyte and internal standard cefetamet were both detected by use of selected reaction monitoring mode. The method was linear in the concentration range of 0.05-8.0 microg/ml. The lower limit of quantification was 0.05 microg/ml. The intra- and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 12.7%. The accuracy determined at three concentrations (0.05, 0.80 and 7.2 microg/ml for cefixime) was within +/-2.0% in terms of relative error. Each plasma sample was chromatographed within 3.5 min. The method herein described was successfully applied for the evaluation of pharmacokinetic profiles of cefixime capsule in 24 healthy volunteers.

Anti-Bacterial Agents↗
PubMed2003

Evaluation of increased incubation temperature and cefixime-tellurite treatment for the isolation of Escherichia coli O157:H7 from minced beef.

To improve enrichment and isolation of Escherichia coli O157:H7, this study evaluated increased incubation temperature and cefixime-tellurite (CT) on five strains of each of the following bacteria, E. coli, Hafnia alvei, Enterobacter spp., Citrobacter freundii and E. coli O157:H7, and two strains of E. coli O157:nH7. These were grown in pure culture in LST broth with varying cefixime-tellurite concentrations. A range of incubation temperatures from 37 to 46 degrees C was investigated for the inhibition of cohabitant microorganisms. Minced beef, spiked with E. coli O157:H7 and cohabitant microorganisms was investigated. Increased incubation temperature (42 degrees C) and treatment with half of the prescribed amount of cefixime-tellurite by BAM for SMAC agar in enrichment step were the most effective in selectively growing E. coli O157:H7. The results show that E. coli O157:H7 is more resistant to these two conditions than the other cohabitant bacteria.

Animals↗
PubMed1998

Combinations of orally administered beta-lactams to maximize spectrum and activity against drug-resistant respiratory tract pathogens: I. Synergy studies of amoxicillin and cefixime with Streptococcus pneumoniae.

Streptococcus pneumoniae strains have emerged that are resistant to penicillin (MICs >0.06 microg/mL) and many other beta-lactams. However, some older compounds such as amoxicillin have potency against these pneumococci with altered penicillin-binding proteins, but are labile to beta-lactamases produced by other prevalent respiratory tract pathogens. The interactions of amoxicillin with an enzyme-stable cephalosporin (cefixime) with a long elimination half-life were examined by the checkerboard dilution method versus 39 S. pneumoniae strains (13 resistant, 15 intermediate, and 11 susceptible to penicillin). Among 24 strains with evaluable drug interaction tests, 17 (71%) demonstrated partial or complete synergy. This favorable interaction produces a cefixime susceptibility category change from resistant or intermediate to susceptible for 16 of 28 strains (57%), when combined with < or = 1 microg/mL amoxicillin. Thus, the use of two currently available oral beta-lactams (amoxicillin twice a day + cefixime once a day; three total doses) appears to be a potential alternative treatment with greater spectrum for community-acquired respiratory tract infections pending clinical trial results.

Administration, Oral↗
PubMed2001

A randomized trial that compared oral cefixime and intramuscular ceftriaxone for the treatment of gonorrhea in pregnancy.

OBJECTIVE: The purpose of this study was to evaluate prospectively the Centers for Disease Control recommendations for the treatment of gonococcal infection in pregnancy. STUDY DESIGN: One hundred sixty-one women who were referred with probable endocervical gonorrhea underwent pretreatment endocervical, anal, and oral cultures for Neisseria gonorrhoeae. The women were randomly assigned to receive ceftriaxone 125 mg intramuscularly or cefixime 400 mg orally. Treatment was open and in a 1:1 distribution. There were 95 evaluable patients. The tests of cure cultures were performed 4 to 10 days after treatment. RESULTS: Eighty-six women (91%) had endocervical infection; 39 women (41%) had anal infection, and 11 women (12%) had pharyngeal infection. Fifty of 95 women (53%) had concomitant endocervical chlamydial infection. The overall efficacy was 91 of 95 subjects (95.8%; 95% CI, 89.6%-98.8%). Ceftriaxone was effective in 41 of 43 cases (95%; 95% CI, 84.2%-99.4%), and cefixime was effective in 50 of 52 cases (96%; 95% CI, 86.8%-99.5%). No significant difference was noted in the overall efficacy or by site of infection. Three of the 4 women who experienced treatment failures admitted to unprotected intercourse before their test of cure culture. CONCLUSION: Both intramuscular ceftriaxone 125 mg and oral cefixime 400 mg appear to be effective for the treatment of gonococcal infection in pregnancy.

Administration, Oral↗
PubMed1989

Safety and efficacy of cefixime versus cefaclor in respiratory tract infections.

A randomized controlled study design was used to compare the efficacy of cefixime versus cefaclor in 30 patients suffering from lower respiratory tract infections. Patients were treated with a 10 to 11 day course of cefixime 200 mg b.i.d. or cefaclor 500 mg t.i.d. The overall clinical response (cured and improved) in the 13 evaluable patients of the cefixime group was 100%. 12 of the 14 patients of the cefaclor group were cured or improved. In the two other patients the symptoms remained unchanged. The bacteriological efficacy in both groups was comparable. Adverse effects were not reported during the study.

Adult↗