title: Pharmacokinetics of a new microemulsion formulation of cyclosporin A (Neoral) in young patients after renal transplantation.
abstract: Pharmacokinetics of the new galenic formulation of cyclosporin A, Neoral, (Sandoz) was examined in 12 stable young patients after renal transplantation. Six of these patients were tested before and 4 weeks after switching from the standard formulation Sandimmun to Neoral. No significant changes were observed in trough levels, Lmax, Cmax, and AUC0-12 h, but the absorption rate constant (Ka) increased (P = 0.03). Glomerular filtration rate, as assessed by inulin clearance, increased by more than 10% in three patients and decreased in two, and was usually associated with a respective drop and rise in Cmax and AUC0-12 h of cyclosporin A. The large interindividual variability in the response to the conversion to the new formulation points to a need for close monitoring of cyclosporin A trough levels and renal function after switching from Sandimmun to Neoral in this age group in order to avoid nephrotoxicity.
authors.affiliation: Division of Pediatric Nephrology, University of Heidelberg, Germany.
authors.forename: R T
authors.initials: RT
authors.lastname: Krmar
authors.forename: E
authors.initials: E
authors.lastname: Wühl
authors.forename: R
authors.initials: R
authors.lastname: Ding
authors.forename: M
authors.initials: M
authors.lastname: Aulmann
authors.forename: K
authors.initials: K
authors.lastname: Schärer
mesh_terms: D000293:Adolescent; D000328:Adult; D001682:Biological Availability; D002648:Child; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D004655:Emulsions; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D007444:Inulin; D007674:Kidney Diseases / Q000139:chemically induced / Q000503:physiopathology; D016030:Kidney Transplantation; D008297:Male
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D007444:Inulin