FLUDROCORTISONE ACETATE ACCORD (acétate de fludrocortisone)

Key points

Positive opinion for reimbursement in the treatment, in cases of mineralocorticoid deficiency, of primary adrenocortical insufficiency (Addison's disease) and classic congenital hyperplasia of the suprarenals (adrenogenital syndrome with salt loss) in combination with a glucocorticoid.

Therapeutic improvement?

No improvement compared to FLUCORTAC (fludrocortisone) 50 µg, scored tablet, an already-listed fludrocortisone-based proprietary medicinal product.

Role in therapeutic strategy?

Treatment of suspected adrenocortical insufficiency should be started without waiting for the results of hormone assays. Management includes replacement therapy, treatment of the cause, if appropriate, therapeutic education of the patient and close monitoring.

It is based on the combined administration of the deficient hormones:

• hydrocortisone to correct glucocorticoid deficiency;
• fludrocortisone to correct mineralocorticoid deficiency when established (classic form with salt-loss).

Role of the medicinal product

Fludrocortisone is an essential replacement therapy. Fludrocortisone, in combination with a glucocorticoid, is a first-line treatment, in cases of mineralocorticoid deficiency, for primary adrenocortical insufficiency (Addison's disease) and congenital hyperplasia of the suprarenals with salt loss in all age groups.

Fludrocortisone is an aldosterone analogue. It must be systematically combined with hydrocortisone for the treatment of adrenocortical insufficiency, as its glucocorticoid activity is too weak for it to be used as a monotherapy at the usual dosages. In primary adrenocortical insufficiency, fludrocortisone is the essential replacement therapy.

FLUDROCORTISONE ACETATE ACCORD 0.1 mg, scored tablet, is an additional therapeutic option for replacement therapy, in cases of mineralocorticoid deficiency, for primary adrenocortical insufficiency (Addison's disease) and classical congenital hyperplasia of the suprarenals (adrenogenital syndrome with salt loss). However, it is not suitable for newborns or infants.

Note that for corticotropic insufficiency, only hydrocortisone is necessary.