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[Clinical evaluation of norfloxacin in children]
1Department of Pediatrics, School of Medicine, Teikyo University.
Insights
Norfloxacin (NFLX) demonstrated 88% efficacy in treating pediatric bacterial infections, including those from resistant strains. This new oral quinolone showed a good safety profile, with no observed arthropathy, suggesting its potential for treating children’s infections.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Context:
- Norfloxacin (NFLX), a novel oral quinolone antibiotic, was investigated for its therapeutic potential in pediatric patients.
- Previous research on quinolone safety in pediatric populations has raised concerns regarding potential adverse effects like arthropathy.
Purpose:
- To evaluate the safety, efficacy, and pharmacokinetic profile of oral norfloxacin (NFLX) in children.
- To determine the effectiveness of NFLX against a range of common pediatric bacterial pathogens.
- To assess the safety of NFLX, specifically monitoring for adverse reactions suggestive of arthropathy.
Summary:
- Norfloxacin demonstrated an 88.0% efficacy rate in 25 pediatric cases involving pathogens such as Haemophilus influenzae, Pseudomonas aeruginosa, Escherichia coli, Campylobacter jejuni, and Staphylococcus aureus (including MRSA).
- Pharmacokinetic studies after single oral doses of 50 mg and 100 mg NFLX showed mean peak serum concentrations of 0.35 and 0.48 microgram/ml, with elimination half-life (T1/2) values of 2.2 and 2.7 hours, respectively.
- Treatment with NFLX at daily doses ranging from 4.6-35.7 mg/kg (max 600 mg/day) for 3 to 19 days did not result in any adverse reactions indicative of arthropathy.
Impact:
- These preliminary findings suggest that norfloxacin (NFLX) is a potentially valuable therapeutic option for managing various infectious diseases in children.
- The favorable safety profile, particularly the absence of arthropathy-related adverse events, supports further investigation of NFLX in pediatric infectious disease treatment.
- The study provides essential data on the efficacy and pharmacokinetics of NFLX, paving the way for its potential clinical application in pediatric populations.
Abstract:
Oral new quinolone, norfloxacin (NFLX, AM-715), was evaluated for its safety, efficacy and pharmacokinetics in children. 1. NFLX was effective in 88.0% of 25 cases infected with Haemophilus influenzae, Pseudomonas aeruginosa, Escherichia coli, Campylobacter jejuni, Staphylococcus aureus including methicillin-resistant strains, and other bacteria. 2. After single oral administration of 50 mg and 100 mg NFLX tablet at fasting, mean peak values of serum concentration were 0.35, 0.48 microgram/ml and T1/2 values were 2.2, 2.7 hours, respectively. 3. No adverse reactions suggestive for arthropathy were encountered with NFLX therapy with daily doses of 4.6-35.7 mg/kg (maximum 600 mg per day) and duration of 3 to 19 days. From these preliminary data, NFLX seems to have a place in the treatment of pediatric infectious diseases.