POSOLOGY AND ADMINISTRATION OF GLUCOCORTICOID BASED COMPOSITIONS

摘要

The present invention relates to an improved method of administration of glucocorticoid based composition in glucocorticoid replacement therapies enabling an objectively based regimen for administration enabling correct individual dosing of glucocorticoids resulting in an optimized individual replacement therapy and thus an improved long-term outcome for patients with temporary or chronic adrenal insufficiency.

主权项

1. An improved method of treating glucocorticoid deficiency, the method comprising administering to a subject in need thereof once daily in the morning a composition in a dose equivalence to hydrocortisone according to the nomograms selected from a weight nomogram;Dose (mg)Body weight (kg)1555-592060-692570-793080-843585-8940 90-100 and wherein the dose is the total daily dose of hydrocortisone to be administered and the body weight is the bodyweight of the subject, and/or a pharmacokinetic nomogram;CcortisolC0 h ≦ 150 nM150 < C0 h ≦ 250 nM250 < C0 h ≦ 350 nM(nM)Dose (mg)Dose (mg)Dose (mg)≧19815105197-16120105160-141251510140-115301510114-97 351510 <97401510 and wherein the dose is the total daily dose of hydrocortisone to be administered and wherein the Ccortisol(nM) is the difference in serum cortisol concentration between 6 hours post-dose and pre-dose as defined herein.