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[Clinical evaluation of cefteram pivoxil fine granules in pediatric infections]
Y Wagatsuma1, A Takase, N Fukushima
1Department of Pediatrics, Sapporo City General Hospital.
Insights
Cefditoren pivoxil (CFTM-PI) fine granules demonstrate effectiveness in treating pediatric infections. This study details its pharmacokinetics and clinical efficacy in children, supporting its use in pediatric infectious disease management.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Infectious Diseases
Context:
- Pediatric infections pose a significant health challenge, necessitating effective and safe antimicrobial agents.
- Cefditoren pivoxil (CFTM-PI) is an oral third-generation cephalosporin antibiotic with broad-spectrum activity.
Purpose:
- To evaluate the pharmacokinetics and clinical efficacy of Cefditoren pivoxil (CFTM-PI) in fine granular form for treating pediatric infections.
- To establish optimal dosing and assess therapeutic outcomes in young patients.
Summary:
- Pharmacokinetic studies in pediatric patients aged 9-15 years showed varying serum concentrations and elimination half-lives (T1/2) based on dosage (3-6 mg/kg) and administration (fasting vs. post-meal).
- Clinical evaluation in 18 pediatric patients (3 months-12 years) demonstrated good to excellent efficacy for CFTM-PI fine granules in treating conditions such as bronchitis, tonsillitis/pharyngitis, and scarlet fever, with fair to good results in bronchopneumonia and urinary tract infections.
- Higher dosages (20 mg/kg/day) showed good clinical efficacy in treating bronchopneumonia, bronchitis, and tonsillitis/pharyngitis.
Impact:
- The findings support the use of Cefditoren pivoxil (CFTM-PI) fine granules as an effective therapeutic option for a range of pediatric infections.
- This study provides valuable data for clinicians prescribing CFTM-PI for pediatric populations, aiding in treatment decisions and dosage adjustments.
Abstract:
Cefteram pivoxil (CFTM-PI), in fine granules, was studied in pediatric infections and the results obtained are summarized below. It is concluded that CFTM-PI fine granule is an effective drug for the treatment of pediatric infections. 1. The pharmacokinetics of CFTM-PI fine granules was studied in 7 patients (5 males, 2 females) whose ages ranged from 9 to 15 years. (1) In 2 patients, administered with the drug at a dose of 3 mg/kg in the fasting state, serum peak concentrations of CFTM at 2 hours after administration were 0.66 and 0.53 micrograms/ml, and T 1/2 were 1.40 and 1.32 hours, respectively. Urinary recovery rates in the first 8 hours were relatively low at 5.8 and 10.8%, respectively. (2) In 1 patient, the drug administered at a dose of 6 mg/kg in the fasting state, serum peak concentration of CFTM at 2 hours after administration was 3.0 micrograms/ml, T 1/2 was 2.16 hours, and urinary recovery rate in the first 8 hours was 13.8%. In another 2 patients, CFTM-PI administered at a dose of 6 mg/kg after meal, serum peak concentrations of CFTM at 4 hours after administration were 5.8 and 2.5 micrograms/ml, T 1/2 of the latter was 1.93 hours, and urinary recovery rates in the first 8 hours were 27.0 and 14.4%, respectively. (3) In yet another 2 patients, CFTM-PI tablets was administered at a dose level of 150 mg after meal. Serum peak concentrations of CFTM were 1.7 and 1.6 micrograms/ml at 2 hours and 4 hours after administration, respectively, T 1/2 of the former was 1.38 hours, and urinary recovery rates were 24.1 and 15.5%, respectively. 2. Clinical results CFTM-PI as fine granules was administered to 18 patients, and the following results were obtained. (1) 12 cases (6 males, 6 females) with their ages ranged from 3 months to 12 years were administered with the drug at a dose of 10 mg/kg/day, divided into 3 equal portions. Clinical efficacies were fair in 1 case with bronchopneumonia, good in 3 cases with bronchitis and in 4 cases with tonsillitis/pharyngitis, excellent in 1 and good in another with scarlet fever, and good in 1 and poor in another with urinary tract infection (UTI) (2) Six cases (4 males, 2 females) with their ages were 6 and 7 years were administered with CFTM-PI at a dose of 20 mg/kg/day divided into 3 equal portions. Clinical efficacies were good in 1 case with bronchopneumonia, 2 cases with bronchitis and 3 cases with tonsillitis/pharyngitis.