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[Bacteriological, pharmacokinetic and clinical studies on cefpodoxime proxetil in the pediatric field]
H Kimura1, H Takeuchi, H Ishikawa
1Department of Pediatrics, Anjo Kosei Hospital.
Insights
Cefpodoxime proxetil (CPDX-PR) demonstrated superior antibacterial activity against common pediatric pathogens and showed high clinical efficacy (91.9%) with no adverse reactions in children, establishing it as a useful oral antibiotic.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and pharmacokinetics
- Microbiology and infectious diseases
Context:
- Cefpodoxime proxetil (CPDX-PR) is a novel oral cephem antibiotic.
- Pediatric infections require effective and safe oral treatment options.
Purpose:
- To evaluate the antibacterial spectrum, pharmacokinetics, and clinical efficacy of cefpodoxime proxetil in pediatric patients.
- To compare the in vitro activity of cefpodoxime (CPDX) with existing oral antibiotics.
Summary:
- Cefpodoxime proxetil exhibited potent in vitro activity against key pediatric pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, Branhamella catarrhalis, and Gram-negative rods, outperforming cefaclor, cephalexin, and cefadroxil.
- Pharmacokinetic studies revealed dose-dependent serum concentrations and half-lives, with a mean urinary recovery rate of 39.2% within 8 hours for a 3 mg/kg fasting dose.
- Clinical trials in 37 pediatric patients with various bacterial infections demonstrated an overall clinical efficacy rate of 91.9% and a bacteriological eradication rate of 91.9%.
Impact:
- Cefpodoxime proxetil is a safe and effective oral antibiotic for treating bacterial infections in children.
- The study supports the use of cefpodoxime proxetil as a valuable therapeutic option in pediatric infectious disease management.
- Favorable pharmacokinetic profile and high clinical success rates indicate good patient compliance and treatment outcomes.
Abstract:
Bacteriological, pharmacokinetic and clinical studies on cefpodoxime proxetil (CPDX-PR, CS-807), a new oral cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized as follows. 1. Antibacterial activities of R-3746 (Na-salt of cefpodoxime (CPDX] against clinically isolated strains of Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Enterococcus faecalis, Branhamella catarrhalis, Escherichia coli, Proteus mirabilis and Haemophilus influenzae were compared with those of cefaclor, cephalexin and cefadroxil. R-3746 is superior to other antibiotics against S. pneumoniae, S. pyogenes, B. catarrhalis and Gram-negative rods. 2. Serum concentrations of CPDX after administration of CPDX-PR at doses of 3 mg/kg (fasting), 6 mg/kg (non-fasting) and 6 mg/kg (fasting) were determined. Mean AUC (area under curve)'s of CPDX obtained were 9.60, 31.35 and 17.89 micrograms.hr/ml, respectively for the 3 dosages. The mean half-lives of CPDX were 3.35, 1.88 and 1.76 hours, respectively. The mean urinary recovery rate within 8 hours after administration of CPDX-PR at a dose of 3 mg/kg (fasting) was 39.2%. 3. CPDX-PR was administered to 37 pediatric patients with various bacterial infections (pyelonephritis 9, cystitis 4, pneumonia 7, acute bronchitis 3, otitis media 2, tonsillitis 10, subcutaneous abscess 1 and purulent lymphadenitis 1). The overall clinical efficacy rate was 91.9% and the overall bacteriological eradication rate was also 91.9%. 4. No adverse reactions were observed. Abnormal laboratory findings were moderate, eosinophilia in 2 and slight elevation of GOT and GPT in 1. The taste and the odor of the CPDX-PR preparation was sufficiently tolerable. From the above results we have concluded that CPDX-PR is a useful oral antibiotic in the treatment of bacterial infections in children.