[Clinical studies on cefteram pivoxil granules in pediatrics]. 1989

H Sato, and A Narita, and S Nakazawa, and H Suzuki, and K Matsumoto, and Y Nakanishi, and K Niino, and S Nakazawa
Department of Pediatrics, Tokyo Metropolitan Ebara General Hospital.

A newly developed cephalosporin, cefteram pivoxil (CFTM-PI, T-2588), was evaluated clinically in 40 patients. A pharmacokinetic study was also performed with 8 patients. CFTM-PI was administered as granules. One patient was given CFTM-PI at a dose of 1.5 mg/kg, each of 3 patients was given the drug at a dose of 3 mg/kg and each of 4 patients at a dose of 6 mg/kg. In most cases, serum concentrations of CFTM were determined at 2, 3, 4, and 6 hours after dosing. Urinary concentrations of CFTM were measured for urinary samples collected during periods of 0-2, 2-4, 4-6 and 6-8 hours after dosing. CFTM was assayed using the disk or the cup method using Klebsiella pneumoniae ATCC 10031 as the test organism. The clinical evaluation was conducted in 40 children including 13 patients of acute tonsillitis, 10 of acute lacunar tonsillitis, 10 of scarlet fever, 2 of acute bronchitis, 2 of pneumonia, and 1 each of pneumonia with enteritis, phlegmon and urinary tract infection. The patients were from 4 months to 13 years old. Daily doses were from 8.7 to 12 mg/kg. After CFTM-PI administration in doses 1.5 mg/kg, 3 mg/kg and 6 mg/kg, peak serum concentrations of CFTM were 0.38 microgram/ml, 0.73-2.25 micrograms/ml and 1.2-2.9 micrograms/ml, respectively, and half-lives were 1.55, 0.95-2.30 and 0.80-2.72 hours, respectively. Urinary excretion rates up to 6 or 8 hours after dosing were 10.8-24.7%. Clinical efficacies of CFTM-PI in 40 patients were "excellent" in 27 children, "good" in 12 children and "fair" in 1 with an efficacy rate of 97.5%. Twenty seven strains of causative organisms, including 15 strains of Streptococcus pyogenes, 1 of Escherichia coli, 1 of Salmonella 04, 6 of Haemophilus influenzae, 1 of Haemophilus parainfluenzae and 3 of Branhamella catarrhalis, were isolated. After treatment all strains except 1 strain of B. catarrhalis (unchanged), Salmonella 04 (unknown) and 1 strain of H. parainfluenzae (unknown) were eradicated. Side effects observed clinically were only 1 case of diarrhea. Eosinophilia was observed in 1 case.

UI MeSH Term Description Entries
D007223 Infant A child between 1 and 23 months of age. Infants
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
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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