Rt. Krmar et al., PHARMACOKINETICS OF A NEW MICROEMULSION FORMULATION OF CYCLOSPORINE-A(NEORAL) IN YOUNG-PATIENTS AFTER RENAL-TRANSPLANTATION, Transplant international, 9(5), 1996, pp. 476-480
Pharmacokinetics of the new galenic formulation of cyclosporin A, Neor
al, (Sandoz) was examined in 12 stable young patients after renal tran
splantation. Six of these patients were tested before and 4 weeks afte
r switching from the standard formulation Sandimmun to Neoral. No sign
ificant changes were observed in trough levels, t(max), C-max, and AUC
(0-12h), but the absorption rate constant (K-a) 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 usua
lly associated with a respective drop and rise in C-max and AUG(0-12h)
, of cyclosporin A. The large interindividual variability in the respo
nse to the conversion to the new formulation points to a need for clos
e monitoring of cyclosporin A trough levels and renal function after s
witching from Sandimmun to Neoral in this age group in order to avoid
nephrotoxicity.