ATC Class:H02AA02

VA Class:HS502

AHFS Class:

• Adrenals 68:04

Generic Name(s):

• Fludrocortisone Acetate

Fludrocortisone acetate is a synthetic glucocorticoid with very potent mineralocorticoid properties.

Mineralocorticoid Replacement

Fludrocortisone acetate is used for oral mineralocorticoid replacement therapy in patients with adrenocortical insufficiency or salt-losing forms of congenital adrenogenital syndrome after electrolyte balance has been restored. Because of its intense sodium-retaining activity, the drug is contraindicated in all conditions except those which require a high degree of mineralocorticoid activity.

In patients with adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) is usually the corticosteroid of choice for replacement therapy. Concomitant administration of a more potent mineralocorticoid (fludrocortisone) may be required in some patients. In salt-losing forms of congenital adrenogenital syndrome, cortisone or hydrocortisone should be administered in conjunction with liberal salt intake. If sodium loss and hypotension are not adequately controlled, fludrocortisone should also be given.

Postural Hypotension

Fludrocortisone acetate has been used with some success to increase systolic and diastolic blood pressure in patients with severe, chronic postural hypotension† (e.g., secondary to autonomic dysfunction, levodopa therapy) that does not respond adequately to nondrug therapy.

Fludrocortisone acetate is administered orally. Dosage depends on the severity of the disease and the response of the patient. Patients should be continually monitored for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).

Mineralocorticoid Replacement

Adrenocortical Insufficiency

For the treatment of adrenocortical insufficiency, the usual dosage of fludrocortisone acetate is 0.1 mg daily, although dosage may range from 0.1 mg 3 times weekly to 0.2 mg daily. If hypertension occurs, 0.05 mg of the drug is given daily. Cortisone (10-37.5 mg daily in divided doses) or hydrocortisone (10-30 mg daily in divided doses) is usually given orally concomitantly with fludrocortisone.

Salt-Losing Forms of Congenital Adrenogenital Syndrome

In the management of salt-losing forms of congenital adrenogenital syndrome, the usual dosage of fludrocortisone acetate is 0.1-0.2 mg daily.

Postural Hypotension

When fludrocortisone acetate was used to increase blood pressure in the management of diabetic patients with postural hypotension†,   0.1-0.4 mg of the drug was given daily. In patients with postural hypotension secondary to levodopa therapy†,   0.05-0.2 mg of fludrocortisone acetate has been given daily.

Chemistry and Stability

Chemistry

Fludrocortisone acetate is a synthetic glucocorticoid with very potent mineralocorticoid properties. Fludrocortisone acetate occurs as hygroscopic, white to pale yellow crystals or crystalline powder and is insoluble in water and sparingly soluble in alcohol. The drug is odorless or practically odorless.

Stability

Fludrocortisone acetate tablets should be stored in well-closed containers at room temperature; excessive heat should be avoided.

Additional Information

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, drug interactions, laboratory test interferences, and dosage and administration of fludrocortisone acetate, see the Corticosteroids General Statement 68:04.