[Fundamental and clinical studies on cefixime in pediatrics]
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Cefixime fine granules demonstrated 100% effectiveness in treating pediatric infections, with excellent or good responses in all patients. This pharmacokinetic and therapeutic evaluation suggests cefixime is a promising antibiotic for children.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacokinetics and Therapeutics
- Antibiotic Efficacy
Context:
- Bacterial infections are a significant concern in pediatric populations.
- Evaluating new antibiotic formulations is crucial for effective treatment.
- Cefixime fine granules offer a potential new therapeutic option.
Purpose:
- To assess the pharmacokinetics of cefixime fine granules in a child.
- To evaluate the therapeutic effectiveness of cefixime fine granules in pediatric patients with various infections.
- To determine the safety profile of cefixime fine granules in children.
Summary:
- Pharmacokinetic analysis in one child showed dose-dependent peak serum concentrations and predictable half-lives.
- A clinical study involving 19 children with diverse bacterial infections demonstrated a 100% therapeutic effectiveness rate.
- Treatment with cefixime fine granules resulted in excellent or good responses in all participants, with minimal and transient laboratory abnormalities observed.
Impact:
- Cefixime fine granules show significant promise as a safe and effective treatment for bacterial infections in children.
- The study supports the use of cefixime fine granules in pediatric infectious disease management.
- Further research may solidify cefixime's role in pediatric antibiotic therapy.
Abstract:
We have evaluated cefixime (CFIX) fine granules for pharmacokinetics and therapeutic effectiveness in children with infections. The results were summarized as follows. Pharmacokinetic parameters after the oral administration of single doses of 1.5 mg and 6.0 mg per kg body weight in a cross-over design in 1 child were as follows: The peak serum CFIX concentrations were 0.65 microgram/ml at 2 to 3 hours and 3.33 micrograms/ml at 4 hours for the low and the high doses, respectively; the respective biological half-lives were 2.4 hours and 2.5 hours, and urinary recovery was 10.3% at 8 hours and 5.2% at 12 hours, respectively. A clinical study was performed on 19 children with infections, including 7 with bronchitis; 3 each with tonsillitis, UTI, and cervical lymphadenitis; and 1 each with pharyngitis, retroauricular lymphadenitis, and enteritis. Doses ranging from 1.8 to 7.8 mg/kg body weight were given b.i.d. or t.i.d. The period of treatment ranged from 3 to 13 days. The therapeutic response was considered "excellent" in 15 and "good" in 4, with an effectiveness rate of 100%. No side effects were observed. The only abnormal laboratory findings was a slight elevation of GOT and GTP recorded in 1 child. It was concluded that CFIX was a promising drug for the treatment of bacterial infections in children.