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Clinical and pharmacokinetic study of nimesulide in children
A G Ugazio1, S Guarnaccia, M Berardi
1Clinica Pediatrica dell'Università, Spedali Civili, Brescia, Italy.
Insights
Nimesulide demonstrated rapid absorption and effective fever reduction in children. This non-steroidal anti-inflammatory drug (NSAID) showed superior antipyretic and anti-inflammatory effects compared to paracetamol.
Area of Science:
- Pharmacology
- Pediatrics
- Clinical Medicine
Background:
- Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with antipyretic properties.
- Pediatric studies are crucial for understanding drug safety and efficacy in younger populations.
Purpose of the Study:
- To evaluate the pharmacokinetic profile of nimesulide in children with hypoglycemia.
- To assess the efficacy and tolerability of nimesulide compared to paracetamol in children with upper respiratory tract infections and fever.
Main Methods:
- Pharmacokinetic study: Oral administration of nimesulide 50mg granules to 14 hypoglycemic children, with plasma concentration monitoring over 12 hours.
- Efficacy study: Randomized clinical trial involving 100 hospitalized children with acute upper respiratory infections and fever, comparing nimesulide oral suspension (5 mg/kg/day) with paracetamol (26 mg/kg/day) for 3 to 9 days.
Main Results:
- Nimesulide was rapidly absorbed, reaching a mean peak plasma concentration of 3.5 mg/L within 2 hours in hypoglycemic children.
- Nimesulide was metabolized to its hydroxy metabolite, detectable from 0.5 hours post-administration, with metabolite levels exceeding parent drug levels by 9 hours.
- Nimesulide demonstrated significantly superior antipyretic and anti-inflammatory effects compared to paracetamol (p < 0.01) in children with upper respiratory infections and fever.
- Both nimesulide and paracetamol were equally well tolerated in the pediatric population studied.
Conclusions:
- Nimesulide exhibits favorable pharmacokinetics and potent antipyretic and anti-inflammatory activity in pediatric patients.
- Nimesulide represents a potentially more effective therapeutic option than paracetamol for managing fever and inflammation in children with acute upper respiratory infections.
- Further research may explore optimal dosing and long-term safety profiles of nimesulide in pediatric populations.
Abstract:
The pharmacokinetic profile and efficacy of nimesulide were assessed in 2 separate studies that recruited children with hypoglycaemia or upper respiratory tract infection and fever, respectively. A single dose of nimesulide 50mg (granules) administered orally to 14 hypoglycaemic children was rapidly absorbed. A mean maximum nimesulide plasma concentration of 3.5 mg/L was achieved within 2 hours of administration, which subsequently declined over the following 12 hours. Nimesulide was metabolised to its principal hydroxy metabolite, which was detectable in samples obtained 0.5 hours after giving the parent drug. Levels of this metabolite steadily increased, surpassing those of intact nimesulide at the 9-hour sampling point. In a randomised nonblind clinical investigation, 100 hospitalised children with acute upper respiratory infections and fever received nimesulide oral suspension (5 mg/kg/day) or paracetamol (26 mg/kg/day) for 3 to 9 days. The antipyretic and anti-inflammatory effects of nimesulide were superior to those observed with paracetamol (p < 0.01) and both drugs were equally well tolerated.