[Bacteriological, pharmacokinetic and clinical studies on cefteram pivoxil in the pediatric field]. 1989

Y Toyonaga, and H Imai, and M Sugita, and Y Fukushima, and M Yamazaki, and M Hori
Department of Pediatrics, Jikei University School of Medicine.

Bacteriological, pharmacokinetic and clinical studies were done on the effect of cefteram pivoxil (CFTM-PI, T-2588) (10% granules), a new oral cephalosporin, in the field of pediatrics. The results are summarized below. 1. Antibacterial activities Antibacterial activities of CFTM against Staphylococcus aureus and Streptococcus pyogenes were studied comparatively with activities of cefaclor (CCL), cephalexin (CEX) and ampicillin (ABPC). MICs of CFTM against S. aureus were distributed in a range between 0.78 and 12.5 micrograms/ml, with a peak value of 3.13 micrograms/ml, which were similar to MIC ranges of CEX and CCL. MICs of CFTM against all strains of S. pyogenes were less than or equal to 0.025 microgram/ml, which were similar to MIC of ABPC. CFTM was approximately 2 to 3 folds more effective than CCL or CEX. 2. Absorption and excretion. Serum concentrations and urinary excretions of CFTM were determined in doses of 3 mg/kg (non-fasting) and 6 mg/kg (non-fasting and fasting). In non-fasting subjects, peak concentrations of CFTM in serum were dose-dependent and were 1.15-2.3 micrograms/ml and 1.8-3.6 micrograms/ml at 2-3 hours, 0.125-0.78 micrograms/ml and 0.245-0.97 micrograms/ml at 6 hours, respectively, for the 2 dose levels. Serum half-lives were 1.03-2.65 hours for the dose of 3 mg/kg and 1.07-1.83 hours for 6 mg/kg. In fasting subjects, the mean peak serum concentrations were 1.73 micrograms/ml at 2 hours and 1.13 micrograms/ml at 6 hours for the dose of 6 mg/kg. Urinary recovery rates in the first 6 hours varied 5.3-19.2%. 3. Clinical study Clinical efficacies were examined in a total of 41 cases including 9 cases of bacterial pneumonia, 10 cases of bronchitis, 11 cases of tonsillitis, 7 cases of urinary tract infections, 3 cases of scarlet fever and 1 case of otitis media. Clinical efficacies were excellent in 30 cases, good in 10 cases, poor in 1 case, hence the efficacy rate was 97.6%. All of the 28 bacteria identified in these cases were eradicated after CFTM-PI treatments. No noticeable abnormalities were found as side effects. An elevation of eosinophil, an increase of platelet count and elevations of GOT and GPT were observed in 3 patients.

UI MeSH Term Description Entries
D008297 Male Males
D008826 Microbial Sensitivity Tests Any tests that demonstrate the relative efficacy of different chemotherapeutic agents against specific microorganisms (i.e., bacteria, fungi, viruses). Bacterial Sensitivity Tests,Drug Sensitivity Assay, Microbial,Minimum Inhibitory Concentration,Antibacterial Susceptibility Breakpoint Determination,Antibiogram,Antimicrobial Susceptibility Breakpoint Determination,Bacterial Sensitivity Test,Breakpoint Determination, Antibacterial Susceptibility,Breakpoint Determination, Antimicrobial Susceptibility,Fungal Drug Sensitivity Tests,Fungus Drug Sensitivity Tests,Sensitivity Test, Bacterial,Sensitivity Tests, Bacterial,Test, Bacterial Sensitivity,Tests, Bacterial Sensitivity,Viral Drug Sensitivity Tests,Virus Drug Sensitivity Tests,Antibiograms,Concentration, Minimum Inhibitory,Concentrations, Minimum Inhibitory,Inhibitory Concentration, Minimum,Inhibitory Concentrations, Minimum,Microbial Sensitivity Test,Minimum Inhibitory Concentrations,Sensitivity Test, Microbial,Sensitivity Tests, Microbial,Test, Microbial Sensitivity,Tests, Microbial Sensitivity
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D002675 Child, Preschool A child between the ages of 2 and 5. Children, Preschool,Preschool Child,Preschool Children
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D001424 Bacterial Infections Infections by bacteria, general or unspecified. Bacterial Disease,Bacterial Infection,Infection, Bacterial,Infections, Bacterial,Bacterial Diseases
D015281 Cefmenoxime A cephalosporin antibiotic that is administered intravenously or intramuscularly. It is active against most common gram-positive and gram-negative microorganisms, is a potent inhibitor of Enterobacteriaceae, and is highly resistant to hydrolysis by beta-lactamases. The drug has a high rate of efficacy in many types of infection and to date no severe side effects have been noted. Abbott-50192,Cefmax,Cefmenoxime Hydrochloride,Cefmenoxime Hydrochloride (2:1),SCE-1365,Abbott 50192,Abbott50192,Hydrochloride, Cefmenoxime,SCE 1365,SCE1365

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