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[Clinical and pharmacokinetic evaluation of cefpodoxime proxetil in children]
H Sakata1, H Kakehashi, K Fujita
1Department of Pediatrics, Asahikawa Medical College.
Insights
Cefpodoxime proxetil (CPDX-PR) demonstrated excellent or good clinical efficacy in 29 pediatric patients across various infections. CPDX-PR was well-tolerated, with mild side effects observed in a small number of children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology
- Clinical Microbiology
Context:
- Bacterial infections are a common concern in pediatric populations, necessitating effective and safe antimicrobial agents.
- Cefpodoxime proxetil (CPDX-PR) is a third-generation oral cephalosporin with broad-spectrum activity.
- Evaluating the clinical utility of novel antibiotic formulations in children is crucial for optimizing treatment guidelines.
Purpose:
- To assess the clinical efficacy and safety of cefpodoxime proxetil (CPDX-PR) in treating various infections in pediatric patients.
- To evaluate the pharmacokinetic profile of CPDX-PR, including serum concentrations and urinary excretion, in children.
- To determine the optimal dosage and duration of CPDX-PR therapy for common pediatric bacterial infections.
Summary:
- Twenty-nine children (2 months to 10 years) with infections including tonsillitis, otitis media, scarlet fever, bronchopneumonia, lymphadenitis, urinary tract infections, and staphylococcal scalded skin syndrome received CPDX-PR (7.5-12.0 mg/kg/day for 5-12.7 days).
- Clinical efficacy was rated as excellent in 21 patients and good in 8 patients. Adverse effects included diarrhea (3 cases) and elevated liver enzymes (2 cases).
- Pharmacokinetic studies in 9 children revealed dose-dependent serum peak concentrations and urinary excretion rates, suggesting good absorption and elimination of CPDX-PR.
Impact:
- CPDX-PR shows significant promise as an effective and generally well-tolerated oral antibiotic for a range of pediatric infections.
- The pharmacokinetic data supports the established dosing regimens and provides a basis for further therapeutic drug monitoring.
- This study contributes valuable real-world data on the use of CPDX-PR in pediatric practice, informing clinical decision-making and potentially improving patient outcomes.
Abstract:
Twenty nine children were treated with cefpodoxime proxetil (CPDX-PR, CS-807) and the clinical efficacy and side effects were evaluated. Ages of the patients ranged from 2 months to 10 years. Dose levels of CPDX-PR ranged from 7.5 to 12.0 mg/kg/day for 5 to 12.7 days. The 29 patients included 9 tonsillitis, 2 otitis media, 5 scarlet fever, 3 bronchopneumonia, 1 lymphadenitis, 8 urinary tract infections and 1 staphylococcal scalded skin syndrome, and they were evaluated for the clinical efficacy of CPDX-PR. Results were excellent in 21 and good in 8 patients. Out of the 29 patients, 3 cases showed diarrhea and 2 cases showed elevated GOT and GPT. The pharmacokinetics of CPDX-PR was studied in 9 patients whose ages ranged from 1 to 9 years. The serum peak concentrations of CPDX in 5 patients were between 1.37 and 4.10 micrograms/ml (mean: 2.53 micrograms/ml) at 1 to 6 hours after dosing 3 mg/kg before meals. Those of 4 patients ranged 3.29 to 4.88 micrograms/ml (mean: 4.36 micrograms/ml) at 2 hours after administering 6 mg/kg before meals. Portions of CPDX excreted into urine within 6 hours ranged from 20.3 to 34.3% (mean 27.1%) in 5 patients who were given 3 mg/kg, and ranged from 24.1 to 65.7% (mean 41.1%) in 4 patients given 6 mg/kg.