title: Neoral monitoring by limited sampling area under the concentration time curve in stable indian renal transplant recipients.
abstract: The optimization of cyclosporine (CsA) immunosuppression remains a challenge because of the narrow therapeutic window and highly variable pharmacokinetics (PK). The highly variable PK were improved by the introduction of the current microemulsion preparation Neoral. However, the best clinical benefit of this CsA microemulsion can only be obtained by regular PK monitoring. During the past decade, various PK strategies have been proposed, such as C(0), C(2), level monitoring, abbreviated or limited sampling approach, and various prediction algorithms to replace the conventional area under the curve (AUC). In this study we evaluated the Neoral PK in stable Indian renal transplant recipients using a limited sampling approach. The C(0) (mean +/- SE) was 175 +/- 15 ng. mL(-1); C(max) 970 +/- 101 ng. mL(-1), and the AUC (0-4) 2734 +/- 258 ng. h. mL(-1). The C(0) showed a poor relationship to AUC (0-4) (r =.65) but high correlations were obtained with C(2) (r = 0.93) and C(3) (r =.96). Our finding suggest that stable Indian renal transplant recipients should either be monitored using C(2) or C(3).
authors.affiliation: Pharmacokinetic Division, Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: J
authors.initials: J
authors.lastname: Jaiswal
authors.forename: S K
authors.initials: SK
authors.lastname: Gupta
authors.forename: S C
authors.initials: SC
authors.lastname: Dash
authors.forename: S C
authors.initials: SC
authors.lastname: Tiwari
authors.forename: S N
authors.initials: SN
authors.lastname: Mehta
authors.forename: Y K
authors.initials: YK
authors.lastname: Gupta
authors.forename: T
authors.initials: T
authors.lastname: Velpandian
mesh_terms: D019540:Area Under Curve; D016572:Cyclosporine / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D016903:Drug Monitoring; D004655:Emulsions; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use; D007194:India; D016030:Kidney Transplantation / Q000502:physiology*; D008657:Metabolic Clearance Rate
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine