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[Fundamental and clinical studies of cefixime in children]
Insights
Cefixime (CFIX) demonstrated high efficacy and safety in pediatric patients with respiratory and urinary tract infections. Pharmacokinetic studies showed comparable serum and urinary levels between capsule and granule formulations.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Clinical Pharmacy
Background:
- Cefixime (CFIX) is a novel oral cephalosporin antibiotic.
- Pediatric dosing and formulation comparisons are essential for effective treatment.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of Cefixime in children.
- To compare serum and urinary levels of Cefixime administered via capsules versus granules.
Main Methods:
- Cefixime was administered to 12 children (2 months to 14 years) at daily doses of 3.4-10.4 mg/kg.
- A separate study compared serum/urinary CFIX levels in 3 children using capsule vs. 5% granule formulations (100 mg dose).
- Therapeutic outcomes and adverse reactions were monitored.
Main Results:
- Peak serum levels averaged 1.4 µg/ml for capsules and 1.9 µg/ml for granules (statistically insignificant difference).
- Cefixime half-life was 5.13 hours (capsules) and 4.17 hours (granules).
- Urinary excretion was 14-18% over 12 hours for both forms. 100% effective rate in respiratory infections, excellent/good in urinary tract infections. No adverse reactions reported.
Conclusions:
- Cefixime exhibits high efficacy and a favorable safety profile in children for moderate respiratory and urinary tract infections.
- Both capsule and granule formulations are effective, with comparable pharmacokinetic profiles.
- Cefixime is a promising therapeutic option for pediatric infections.
Abstract:
Cefixime (CFIX), a new oral cephalosporin, was administered clinically at a daily dose of 3.4 mg/kg to 10.4 mg/kg to each of 12 children, aged from 2 months to 14 years old. An additional separate study was done to compare the serum and urinary levels of CFIX in 3 children when each was administered with 100 mg of the drug in capsule with the serum and urinary levels of the drug in the same children when each was given the same amount of drug in the form of 5% granules. The results of these trials are summarized below. Peak serum levels of CFIX administered in capsules and 5% granules averaged 1.4 micrograms/ml and 1.9 micrograms/ml, respectively. The half-life of the former was 5.13 hours, while that of the latter was 4.17 hours. The difference in the peak levels was statistically insignificant. The urinary excretion of CFIX in either form of the drug (capsules and granules) was about 14-18% in 12 hours. In 9 cases of respiratory infections, therapeutic results were excellent in 3 cases, good in 6 cases, and the effective rate was 100%. In 2 cases of urinary tract infection, results were excellent in 1 case and good in 1 case. The drug efficacy was poor in 1 case of purulent cervical lymphadenitis, probably caused by Staphylococcus aureus. No adverse reactions attributable to the drug were observed. CFIX may be expected to be a highly effective and safe agent in moderate respiratory and urinary tract infections of children.