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[Laboratory and clinical studies of cefteram pivoxil in pediatric field]
T Nishimura1, K Tabuki, T Takashima
1Department of Pediatrics, Osaka Medical College.
Insights
Cefteram pivoxil (CFTM-PI) demonstrated favorable pharmacokinetics and high efficacy in pediatric bacterial infections, with excellent or good results in all 36 cases and no significant side effects observed.
Area of Science:
- Pharmacology
- Pediatric Infectious Diseases
Context:
- Cefteram pivoxil (CFTM-PI) is an oral antibiotic.
- Pediatric bacterial infections require effective and safe treatment options.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of cefteram pivoxil in pediatric patients.
- To assess the safety profile of CFTM-PI in children.
Summary:
- Laboratory and clinical studies were conducted on cefteram pivoxil (CFTM-PI).
- Oral administration in children at doses of 1.5, 3, and 6 mg/kg showed dose-dependent peak serum levels and half-lives.
- Urinary excretion rates varied with dosage.
- CFTM-PI was administered to 36 children with various bacterial infections, including tonsillitis, bronchitis, and UTI.
- Excellent or good clinical outcomes were achieved in all cases, with no significant adverse effects reported.
Impact:
- Cefteram pivoxil shows promise as an effective and safe oral antibiotic for treating pediatric bacterial infections.
- The findings support the further investigation and potential clinical use of CFTM-PI in pediatric populations.
Abstract:
We have carried out laboratory and clinical studies on cefteram pivoxil (CFTM-PI, T-2588). The results are summarized as follows. CFTM-PI was given through oral administration to 2 children each at dose levels of 1.5 mg/kg, 3 mg/kg and 6 mg/kg. After administration, mean peak serum levels of CFTM obtained for the 3 dose levels were 0.66 +/- 0.01 microgram/ml, 1.26 +/- 1.05 micrograms/ml and 2.28 +/- 0.95 micrograms/ml at 2 hours, respectively, and mean half-lives were 1.07 +/- 0.52 hours, 1.32 +/- 0.76 hours and 2.53 +/- 1.70 hours, respectively. Mean urinary excretion rates of CFTM were 19.0 +/- 4.0%, 9.4 +/- 1.5% and 19.9 +/- 4.0% in the first 8 hours after administration of 1.5 mg/kg, 3 mg/kg, 6 mg/kg, respectively. Treatment with CFTM-PI was made in 36 cases of pediatric bacterial infections including 20 cases of tonsillitis, 3 cases of bronchitis, 6 cases of scarlet fever, 3 cases of UTI and 1 case each of bronchopneumonia, abscess, staphylococcal scalded skin syndrome and vaginitis. Results obtained were excellent in 22 cases, good in 14 cases. No significant side effect due to the drug was observed in any cases.