To determine the relative bioavailability and plasma paracetamol concentration profiles following administration of a proprietary formulation of paracetamol suppositories to postoperative children.
Study A-eight children undergoing minor surgery had blood samples collected following the rectal administration of either a 250 mg or 500 mg paracetamol suppository on one day and an equivalent oral dose on the following day.
A mean dose of 13 mg/kg gave a mean Cmax (Tmax) of 7.7 mg/L (1.6 h) and 4.9 mg/L (2.0 h) following oral and rectal administration, respectively.
The mean relative rectal bioavailability was 78% (95% confidence interval of 55-101%). Study B-20 children undergoing tonsillectomy and/or adenoidectomy were randomly assigned to receive a postoperative dose of 500 mg of paracetamol either as 2 x 250 mg liquid filled or 1 x 500 mg hard wax Panadol suppository.
A mean dose of 25 mg/kg produced mean maximum plasma paracetamol concentrations of 13.2 mg/L and 14.5 mg/L at 2.1 and 1.9 h for the hard and liquid filled suppository, respectively.
The absorption rate constants and areas under the curves suggested no difference in the rate or extent of absorption between the two formulations.
Absorption of paracetamol following rectal administration of Panadol suppositories to postoperative children is slower and reduced as compared to oral therapy. (...)
Mots-clés Pascal : Paracétamol, Etude comparative, Biodisponibilité, Concentration, Voie orale, Voie rectale, Absorption, Enfant, Homme, Chirurgie, Analgésique, Antipyrétique, Pharmacocinétique
Mots-clés Pascal anglais : Paracetamol, Comparative study, Bioavailability, Concentration, Oral administration, Rectal administration, Absorption, Child, Human, Surgery, Analgesic, Antipyretic, Pharmacokinetics
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 98-0512366
Code Inist : 002B02B05. Création : 23/03/1999.