Neoral a equoral
Several bioequivalence studies with a total of healthy volunteers and a pharmacokinetic conversion study with 70 stable adult renal transplant recipients compared the brand leader Neoral with Equoral.
Number of times cited: Abstract According to the US Food and Drug Administration FDAif a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted switchable for that drug product.
Histologically confirmed acute rejection episodes were treated with methylprednisolone boluses. Graft loss was defined as death or return to hemodialysis.
Reduced inter- and intraindividual variability in Cyclosporin pharmacokinetics from a microemulsion formulation. This hematologic side effect was mild and reversible with reduction in cyclosporin dose. Mean serum creatinine level decreased significantly after transplantation.
Didn't get the message? Previous article in issue: Equoral treatment demonstrated an acceptable safety profile, with maintenance of satisfactory and stable graft function.
Patients with adverse events recovered without sequelae, and the adverse events resolved with a reduction in cyclosporin dose; thus, cyclosporin dosage was readjusted in some cases. Over the month post-transplant period, graft function was very good and stable. Didn't get the message? Additional concentrations were measured on days -7, 18, and A novel microemulsion formulation, Neoral Novartis, Bern, Switzerlandwas therefore developed to circumvent these problems.
These findings are in agreement with those of several other studies that identified good results with Equoral treatment in the prevention of acute rejection and patient and graft survival after renal transplantation. The first original calcineurin inhibitor, Sandimmune Novartis, Bern, Switzerlandwas characterized by high intrapatient and interpatient pharmacokinetic variability, with poor bioavailability to many patients. Monoclonal antibodies were not used as induction agents in this study.
Generate a file for use with external citation management software. With the exception of hypertension, there were no reports of other frequent Cyclosporin-related adverse events, such as hirsutism, tremor, gastrointestinal disturbance, and renal dysfunction indicated by increased creatinine levels.
Choose an option to locate/access this article:
The inhibition of calcineurin phosphatase suppresses activation of mainly T cells but also other molecules involved in cell-mediated immunity. The evaluation of the safety and tolerability of two formulations of Cyclosporin: The progressive decrease in cyclosporin doses The causes of their end-stage renal disease before transplantation varied: Corticosteroid treatment comprised methylprednisolone boluses day 0, mg; day 1, mgfollowed by a rapid prednisone taper from 30 mg, on day 2, to 20 mg, on day 15, to 15 mg, in month 3, to 10 mg, in month 6 and thereafter.
On day 14 a hour PK profile included predose, 30 minutes; 1 hour; 1 hour 30 minutes; 2 hours; 3 hours; 4 hours; 5 hours; 6 hours; 8 hours; hours and hour samples. According to the US Food and Drug Administration FDAif a drug product contains a drug substance that is chemically identical and is delivered to the site of action at the same rate and extent as another drug product, then it is equivalent and can be substituted switchable for that drug product.