Fludrocortisone (Fludrocortisone Acetate) - Indications and Dosage

INDICATIONS AND USAGE

Fludrocortisone acetate tablets USP, 0.1 mg are 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 AND ADMINISTRATION

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 remission 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 fludrocortisone acetate tablets 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 fludrocortisone acetate tablets 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. Fludrocortisone acetate tablets are 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 fludrocortisone acetate tablets daily.

HOW SUPPLIED

Fludrocortisone Acetate Tablets USP, 0.1 mg—Each white to off-white, round, convex tablet debossed with a "7033" on one side and with a bisect on the other side.

Bottles of 100........................................NDC 0115-7033-01
Bottles of 500........................................NDC 0115-7033-02
Bottles of 1000......................................NDC 0115-7033-03

Store at controlled room temperature 15° to 30°C (59° to 86°F)(see USP). Avoid excessive heat.

Dispense in a tightly-closed, light-resistant container (USP).

Mfg. by:
IMPAX Laboratories, Inc.
30831 Huntwood Avenue
Hayward, California 94544

Dist. by:
Global Pharmaceuticals
Division of IMPAX Laboratories, Inc.
Philadelphia, PA 19124

218-01
rev. 7/01