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Serum concentrations and safety of rimantadine in paediatric patients
Insights
Rimantadine is safe for infants with influenza A at a daily dose of 3 mg/kg. Pediatric studies show varied serum concentrations, with potential adverse effects linked to high levels or prolonged use.
Area of Science:
- Pharmacology
- Pediatric Infectious Diseases
Background:
- Rimantadine demonstrates superior in vitro activity and lower toxicity compared to amantadine in adult influenza A treatment.
- Limited research exists on rimantadine's efficacy and safety in pediatric populations, particularly infants.
Purpose of the Study:
- To assess serum concentrations and adverse effects of repeated oral doses of rimantadine in infants.
- To establish a safe and effective dosing regimen for rimantadine in pediatric patients.
Main Methods:
- Fourteen infants (1-10 months) received 3 mg/kg/day of rimantadine syrup for 10 days.
- Serum concentrations were measured at various intervals post-dose during days 5-9.
- Adverse effects were monitored through clinical assessment and laboratory parameters.
Main Results:
- Steady-state peak serum rimantadine concentrations ranged from 100-574 ng/ml, with Tmax between 2.5-6.0 hours.
- Hematuria was observed in one infant with the highest concentration and longest treatment duration; it resolved post-therapy.
- No other adverse effects were noted in the study cohort.
Conclusions:
- Rimantadine, at 3 mg/kg/day once daily, appears safe for infants.
- Significant inter-individual variability in serum concentrations and Tmax was observed.
- Further investigation is warranted to explore the association between high serum concentrations, prolonged treatment, and adverse events in infants.
Abstract:
Rimantadine has been shown to be more active in vitro and less toxic than amantadine in adults with influenza A disease. Because of a lack of studies in pediatric patients, we designed a study to evaluate serum concentrations and adverse effects of rimantadine in infants receiving repeated doses. Fourteen hospitalized infants (ages 1-10 months) were given rimantadine syrup at 3 mg/kg/dose in single daily doses during influenza season. Blood samples were obtained prior to dose and at various intervals up to 8 h after doses on the fifth to ninth days of therapy. Adverse effects were assessed based on clinical status, activity level, hematologic and biochemical parameters during 10-day therapy. Steady-state rimantadine peak serum concentration ranged from 100 to 574 ng/ml and time to achieve peak concentration ranged from 2.5 to 6.0 h after the doses. No adverse effects were seen except hematuria in one infant; this patient had the highest rimantadine concentration and longest treatment duration. Hematuria resolved during a follow-up evaluation on the ninth day after stopping therapy. Our data suggest that rimantadine can be given safely at repeated doses of 3 mg/kg/dose in a convenient once-daily regimen; the steady-state peak serum concentrations and time to achieve peak concentration may vary substantially in infants receiving same oral doses; and possible association of adverse effects and high serum concentration or long treatment duration of rimantadine needs further evaluation in small infants.