Fludrocortisone Acetate is indicated for oral mineralocorticoid replacement therapy in the following conditions:

• Primary and secondary adrenocortical insufficiency (Addison’s disease)
• Salt-losing adrenogenital syndrome
• Postural (orthostatic) hypotension

Fludrocortisone is a synthetic adrenocortical steroid that exhibits potent mineralocorticoid activity along with notable glucocorticoid effects. It is used as a partial replacement therapy in both primary and secondary adrenocortical insufficiency, including Addison’s disease, and for the treatment of salt-losing adrenogenital syndrome. Its pharmacological action is similar to that of hydrocortisone; however, fludrocortisone acetate produces more intense and prolonged effects, particularly on electrolyte balance as well as carbohydrate metabolism. Mineralocorticoids act on the distal tubules of the kidney to enhance the reabsorption of sodium ions from tubular fluid into the bloodstream, while simultaneously increasing the excretion of potassium and hydrogen ions through urine.

Fludrocortisone acts by binding to and activating the mineralocorticoid (aldosterone) receptor. Activation of this receptor enhances sodium and water reabsorption while promoting potassium excretion. As a result, extracellular fluid volume and blood pressure increase, and serum potassium levels decrease.

Primary and secondary Adrenocortical Insufficiency in Addison’s disease: Usual dose may range from 0.2 mg 3 times weekly to 0.2 mg daily. If hypertension occurs, reduce dosage to 0.05 mg daily. Administer concomitantly with Cortisone or hydrocortisone.

Salt-Losing Adrenogenital Syndrome: 0.1 to 0.2 mg/day.

Postural Hypotension: 0.1-0.4 mg daily to diabetic patients with postural hypotension; 0.05-0.2 mg daily to patients with postural hypotension secondary to Levodopa therapy.

Fludrocortisone may interact with the following medications: amphotericin B; potassium-depleting diuretics; anticholinesterases; anticoagulants; antidiabetic agents; antitubercular drugs; cyclosporine; digitalis glycosides; oral contraceptives; and ketoconazole.

In adrenal insufficiency, there are no absolute contraindications to the use of fludrocortisone. However, when it is administered in pharmacological doses for non-endocrine conditions, contraindications should be carefully evaluated. Relative contraindications include systemic fungal infections, known hypersensitivity to fludrocortisone, diabetes mellitus, osteoporosis, and acute infections.

Most adverse reactions are related to the mineralocorticoid effects of the drug, particularly sodium and water retention. These may include erythema, purpura, vertigo, pancreatitis, increased intraocular pressure, muscular weakness, hypertension, edema, cardiac enlargement, congestive heart failure, steroid myopathy, peptic ulcer, osteoporosis, convulsions, menstrual irregularities, potassium loss, hypokalemic alkalosis, and allergic or anaphylactic reactions. When fludrocortisone is administered at the low doses recommended, side effects are generally uncommon. However, the above adverse effects should be considered, especially during prolonged therapy or when used in combination with cortisone or other glucocorticoids.

Pregnancy – Category C: There are no adequate and well-controlled studies in pregnant women. Fludrocortisone should be used during pregnancy only if no safer alternatives are available and if the potential benefits justify the possible risks to the fetus.

Lactation: There is no specific information regarding the excretion of fludrocortisone into human breast milk. However, systemically administered corticosteroids are known to pass into breast milk and may cause growth suppression or other adverse effects in nursing infants. Therefore, caution is advised when fludrocortisone is administered to breastfeeding women.

Due to its pronounced sodium-retaining properties, fludrocortisone is not recommended for the treatment of conditions other than those specifically indicated. It should be used with caution in patients with infections such as tuberculosis, measles, chickenpox, herpes zoster, or threadworm infestation, as well as in those with congestive heart failure, hypertension, renal insufficiency, osteoporosis, drug-induced secondary adrenocortical insufficiency, peptic ulcer, intestinal anastomosis, or ulcerative colitis.

Overdosage is unlikely to occur; however, if it does, management should consist of supportive and symptomatic treatment.

Corticosteroid.

Store below 30°C, protected from light and moisture. Keep out of reach of children.