Fludrocortisone Acetate

Indications

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 (summary)

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 gluco-corticoid such as hydrocortisone or cortisone provides substitution therapy approximating normal adrenal activity with minimal risks of unwanted effects.

Contraindications

CONTRAINDICATIONS Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a history of possible or known hypersensitivity to these agents.

Warnings and precautions

WARNINGS BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION THE USE OF FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER THAN THOSE INDICATED HEREIN IS NOT ADVISED. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used. If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by suitable antimicrobial therapy.

Pregnancy

Pregnancy Teratogenic Effects: Category C Adequate animal reproduction studies have not been conducted with fludrocortisone acetate. However, many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Teratogenicity of these agents in man has not been demonstrated.

Storage and supply

Store at controlled room temperature 15° to 30°C (59° to 86°F)(see USP). Avoid excessive heat. Dispensed in Unit Dose Package. For Institutional Use Only. Keep out of the reach of children.

Source: Fludrocortisone Acetate (Fludrocortisone Acetate) — US FDA prescribing information, 2026-01-08, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.