Clinical and pharmacokinetic study of nimesulide in children

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.