Pharmacokinetics of a new microemulsion formulation of cyclosporin A (Neoral) in young patients after renal transplantation.
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.
Krmar
R T
RT
Division of Pediatric Nephrology, University of Heidelberg, Germany.
Wühl
E
E
Ding
R
R
Aulmann
M
M
Schärer
K
K
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
D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D007444:Inulin