Florinef Acetate is indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease and for the treatment of salt-losing adrenogenital syndrome.

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) (see WARNINGS and PRECAUTIONS, General).

Addison's Disease

In Addison's disease, the combination of Florinef Acetate (Fludrocortisone Acetate Tablets USP) with a glucocorticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects.

The usual dose is 0.1 mg of Florinef Acetate daily, although dosage ranging from 0.1 mg three times a week to 0.2 mg daily has been employed. In the event transient hypertension develops as a consequence of therapy, the dose should be reduced to 0.05 mg daily. Florinef Acetate is preferably administered in conjunction with cortisone (10 mg to 37.5 mg daily in divided doses) or hydrocortisone (10 mg to 30 mg daily in divided doses).

Salt-Losing Adrenogenital Syndrome

The recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of Florinef Acetate daily.

Florinef Acetate Tablets (Fludrocortisone Acetate Tablets USP), 0.1 mg/tablet: white, round, biconvex, scored tablets in bottles of 100 (NDC 61570-190-01); identification no. 429.

Storage

Store at room temperature; avoid excessive heat.

Prescribing Information as of July 2003. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. (A wholly wned subsidiary of King Pharmaceuticals, Inc.) Manufactured by: Bristol-Myers Squibb Company, Princeton, NJ 08540 USA. FDA Rev date: 6/9/2004

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