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[Pharmacokinetic and clinical studies on cefprozil granules in the pediatric field]
1Department of Pediatrics, School of Medicine, Kurume University.
Insights
Cefprozil (CFPZ), a new oral cephalosporin, demonstrated significant antimicrobial activity against common pediatric bacterial pathogens. Clinical studies confirmed its efficacy and tolerability in treating various childhood infections.
Area of Science:
- Pharmacology
- Microbiology
- Pediatrics
Background:
- Cefprozil (CFPZ) is a novel oral cephalosporin developed for pediatric use.
- Bacterial infections in children require effective and safe antimicrobial agents.
Purpose of the Study:
- To evaluate the in vitro antimicrobial activity of Cefprozil (CFPZ) against clinical isolates from pediatric patients.
- To assess the pharmacokinetics and clinical efficacy of Cefprozil (CFPZ) in children with bacterial infections.
Main Methods:
- Minimum Inhibitory Concentrations (MICs) were determined for CFPZ and other antibiotics against Gram-positive cocci and Gram-negative bacilli.
- Pharmacokinetic parameters including serum and urinary concentrations were analyzed using bioassay and HPLC.
- Clinical and bacteriological efficacy, along with adverse reactions, were evaluated in 160 pediatric cases.
Main Results:
- CFPZ exhibited potent activity against Streptococcus pyogenes (MIC < 0.025 µg/ml) and moderate activity against Staphylococcus aureus.
- Pharmacokinetic studies showed measurable serum and urinary concentrations of CFPZ.
- Clinical studies reported favorable efficacy in treating diverse infections like scarlet fever and urinary tract infections.
Conclusions:
- Cefprozil (CFPZ) is an effective oral cephalosporin for treating bacterial infections in children.
- The drug demonstrated a good safety profile with acceptable pharmacokinetic properties.
Abstract:
Cefprozil (CFPZ), a newly developed oral cephalosporin in a fine granular form for pediatric use, was administered to children with bacterial infections. MICs were determined for 6 drugs including CFPZ, cephalexin (CEX), cefaclor (CCL), ampicillin (ABPC), methicillin (DMPPC) and cloxacillin (MCIPC) against the following 84 strains isolated from cases to which CFPZ was administered; 55 strains of Gram-positive cocci (GPC) including 2 strains of Staphylococcus aureus, 49 strains of Streptococcus pyogenes, 4 strains of Streptococcus pneumoniae, and 29 strains of Gram-negative bacilli (GNB) including 10 strains of Haemophilus influenzae, 18 strains of Escherichia coli, and 1 strain of Proteus mirabilis. MIC determination of these strains was done with an inoculum size of 10(6) CFU/ml. In pharmacokinetic studies, serum concentrations, urinary concentrations and urinary recovery rates were investigated using bioassay and high-performance liquid chromatography (HPLC). CFPZ was orally administered 30 minutes before meals to 9 children with ages ranging from 7 years and 1 month to 12 years and 3 months. Three groups of 3 children were tested with doses of 4.0, 7.5 and 15.0 mg/kg, respectively. In addition to the above, clinical and bacteriological studies were performed in a total of 160 cases consisting of children with ages ranging 5 months to 12 years and 5 months. A mean dose of 8.6 mg/kg in 3-4 divided doses (130 cases of t.i.d. and 30 cases of q.i.d.) was administered for an average of 7 days. The 160 cases included 34 cases of pharyngitis, 5 cases of tonsillitis, 8 cases of acute bronchitis, 8 cases of pneumonia, 52 cases of scarlet fever, 4 cases of acute purulent otitis media, 47 cases of urinary tract infection, 1 case of purulent lymphadenitis and 1 case of posthitis. Adverse reactions and abnormal clinical laboratory test results were also examined in 166 cases, including 6 cases excluded from the evaluation of clinical efficacy. The results obtained are summarized as follows: 1. With regard to GPC, MICs of CFPZ against 2 strains of S. aureus were 0.78 or 1.56 micrograms/ml and CFPZ showed the second highest activity to MCIPC. MICs of CFPZ against 49 strains of S. pyogenes were all less than 0.025 micrograms/ml.(ABSTRACT TRUNCATED AT 400 WORDS)