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[Fundamental and clinical studies on cefadroxil dry syrup in children (author's transl)]
Insights
Cefadroxil dry syrup, a new oral cephalosporin, demonstrates potent antibacterial activity and high efficacy in treating pediatric infections. This study confirms its safety and palatability for children, establishing an appropriate dosage regimen.
Area of Science:
- Pharmacology
- Microbiology
- Pediatrics
Context:
- Cefadroxil is a novel oral cephalosporin antibiotic.
- Evaluation of cefadroxil's efficacy and safety in pediatric patients is crucial for expanding treatment options.
Purpose:
- To assess the antibacterial spectrum and potency of cefadroxil.
- To determine the pharmacokinetic profile of cefadroxil dry syrup in children.
- To evaluate the clinical efficacy and safety of cefadroxil in treating pediatric bacterial infections.
Summary:
- Cefadroxil exhibited comparable antibacterial activity to cephalexin against common pathogens like S. aureus and E. coli, with higher MICs for certain Gram-negative bacteria.
- Oral administration resulted in peak serum concentrations within 1-2 hours, sustained levels, and high urinary recovery rates (75-96%).
- Clinical trials showed 100% efficacy in treating tonsillitis and urinary tract infections in children, with no significant adverse reactions reported besides mild liver enzyme elevation in one case.
Impact:
- Cefadroxil dry syrup is a safe and effective oral cephalosporin for pediatric bacterial infections.
- The study provides evidence supporting a recommended daily dosage of 40 mg/kg in 3-4 divided doses for children.
- Favorable palatability suggests improved patient compliance in pediatric populations.
Abstract:
Fundamental and clinical studies were made on cefadroxil, a new oral cephalosporin, and the following results were obtained. (1) Antibacterial activity of the drug against S. aureus, S. epidermidis, E. coli, Klebsiella, Salmonella and P. mirabilis was almost equal to that of cephalexin. The MIC of indole positive Proteus. Enterobacter, Citrobacter, S. marcescens and P. aeruginosa to cefadroxil was higher than 100 microgram/ml in almost all strains. (2) Serum concentrations following an oral administration of 10.0 to 14.3 mg/kg of cefadroxil dry syrup was highest at 2 hours in 2 cases and 1 hour in 1 case, respectively, which were 13.4 to 17.1 microgram/ml, and 1.8 to 6.8 microgram/ml at 4 hours with an T 1/2 of 1.04 to 1.62 hours and apparently longer continuation of serum concentration than that of cephalexin. Urinary recovery rate was 75-96% up to 6 hours. (3) Fourteen patients, i.e., 6 with tonsillitis and 8 with urinary tract infection, were treated with a daily oral dose of 30-50 mg/kg divided in 4 doses except 1 case divided in 3 doses. The overall efficacy rate was 100%, i.e., excellent in 13, good in 1 and no failure. Causative organisms disappeared in all cases. (4) Adverse reactions, such as diarrhea and skin rash, were not noted at all and 1 case presented a mild elevation of GOT and GPT. (5) Taste and flavor of the drug was well palatable to children. (6) Based on the above results, it is concluded cefadroxil dry syrup is a new potent cephalosporin for oral use in the treatment of acute bacterial infection in children. Daily dose of 40 mg/kg in 3-4 divided doses appeared to be appropriate.