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[Laboratory and clinical studies of cefpodoxime proxetil in pediatric field]
T Nishimura1, K Tabuki, S Aoki
1Department of Pediatrics, Osaka Medical College.
Insights
Cefpodoxime proxetil (CPDX-PR) demonstrated favorable pharmacokinetics and efficacy in pediatric bacterial infections. Clinical studies showed good to excellent treatment outcomes with no significant side effects observed.
Area of Science:
- Pharmacology
- Clinical Microbiology
Context:
- Cefpodoxime proxetil (CPDX-PR) is an oral third-generation cephalosporin antibiotic.
- Pediatric bacterial infections require effective and safe therapeutic options.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of cefpodoxime proxetil in pediatric patients.
- To assess the safety profile of cefpodoxime proxetil in children.
Summary:
- Laboratory and clinical studies were conducted on cefpodoxime proxetil (CPDX-PR).
- Oral administration in children showed peak serum levels of cefpodoxime (CPDX) at 2 hours and mean half-lives of approximately 1.3-1.5 hours.
- Urinary excretion rates varied, with a mean of 32.8% in 12 hours for the 3 mg/kg dose.
- CPDX-PR was administered to 38 children with various bacterial infections, including tonsillitis, pneumonia, and UTI.
- Treatment outcomes were excellent in 23 cases and good in 15 cases, with no significant adverse effects reported.
Impact:
- Cefpodoxime proxetil exhibits promising pharmacokinetic properties for pediatric use.
- The drug demonstrated high efficacy in treating a range of common pediatric bacterial infections.
- CPDX-PR appears to be a safe and well-tolerated antibiotic option for children.
Abstract:
We have carried out laboratory and clinical studies on cefpodoxime proxetil (CS-807, CPDX-PR). The results are summarized as follows. CPDX-PR was given via oral administration to each 2 children at a single dose of 3 mg/kg and to each of 3 children in a 100 mg tablet. After the oral administration, mean peak serum levels of CPDX obtained for the 2 dose levels were 1.86 +/- 0.35 micrograms/ml and 2.16 +/- 0.63 micrograms/ml at 2 hours, respectively, and mean half-lives were 1.31 +/- 0.02 hours and 1.47 +/- 0.18 hours, respectively. The mean urinary excretion rate of CPDX was 32.8 +/- 1.0% in the first 12 hours after the oral administration of 3 mg/kg. When a dose of 100 mg tablet was given to each of the 3 children, urinary excretion rates in the first 12 hours were 43.5%, 48.6% and 24.8%, respectively. Treatment with CPDX-PR was done in 38 cases of pediatric bacterial infections; 19 cases of tonsillitis, 3 cases of pharyngitis, 1 case of bronchitis, 3 cases of pneumonia, 3 cases of scarlet fever, 2 cases of impetigo, 4 cases of UTI and 1 case each of phlegmone, subcutaneous abscess and balanitis. Results obtained were excellent in 23 cases, good in 15 cases. No significant side effect due to the drug was observed in any cases.