Fludrocortisone Acetate

Fludrocortisone Acetate belongs to a group of medicines called steroids. It is used in the treatment of Addison's disease (inadequate production of natural steroid hormones by the adrenal glands) and congenital adrenal hyperplasia (a genetic condition that affects the adrenal glands).

Fludrocortisone is a synthetic adrenocortical steroid possessing very potent mineralocorticoid properties and high glucocorticoid activity. It is indicated as partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease.

• Addison's Disease: Used for primary and secondary adrenocortical insufficiency.
• Congenital Adrenal Hyperplasia: Used for salt-losing adrenogenital syndrome.
• Postural Hypotension: Used for orthostatic hypotension.

Corticosteroid

Mineralocorticoid

Fludrocortisone binds the mineralocorticoid receptor (aldosterone receptor). This binding (or activation of the mineralocorticoid receptor by fludrocortisone) in turn causes an increase in ion and water transport and thus raises extracellular fluid volume and blood pressure and lowers potassium levels.

Potent mineralocorticoid with high glucocorticoid activity; Fludrocortisone promotes increased reabsorption of sodium and excretion of potassium from renal distal tubules.

Adult Dose (Oral):

• Addison's Disease (Primary and Secondary Adrenocortical Insufficiency): 0.1 mg/day; range 0.1 mg 3 times weekly to 0.2 mg/day; if hypertension occurs: 0.05 mg/day.
• Salt-Losing Adrenogenital Syndrome: 0.1-0.2 mg/day.
• Postural Hypotension: 0.1-0.4 mg daily for diabetic patients; 0.05-0.2 mg daily for levodopa-induced postural hypotension.

Child Dose: Not FDA-approved for use in children.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Fludrocortisone Acetate is to be taken with food.

If you miss a dose of Fludrocortisone Acetate, take it as soon as possible; however, if it is almost time for your next dose, skip the missed dose.

Common Side Effects:

• Behavioral changes
• Weight gain
• Bone disorder
• Thinning of skin
• Altered blood sugar level
• Mood changes
• Upset stomach

Other Side Effects: 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, allergic and anaphylactic reactions.

Precautions:

• Fludrocortisone Acetate does not usually affect your ability to drive.
• Used for treatment of Addison's disease; corrects electrolyte imbalances.
• Take with food to avoid stomach upset.
• Your doctor may get regular blood tests to monitor electrolyte (sodium) levels.
• Regularly monitor your blood pressure, salt intake, and weight.
• Inform doctor before receiving any vaccines (may re-activate old infections).
• Inform doctor if you have or had hepatitis B, C, or tuberculosis.
• Do not stop taking the medication suddenly.
• Caution in patients with infections (tuberculosis, measles, chicken pox, herpes zoster), congestive cardiac failure, hypertension, renal insufficiency, osteoporosis, peptic ulcer.

Contraindications:

• Hypersensitivity
• Hyperalbuminaemia
• Hypertension
• Systemic fungal infections

Drug Interactions:

• Salicylates: May decrease levels.
• Anticholinesterases: Effects are antagonised.
• Rifampin, barbiturates, hydantoins, phenytoin: Decreased effects.
• Oral contraceptives or ritonavir: May increase plasma concentrations.
• Potassium-depleting drugs (thiazides, furosemide, amphotericin B): Increased potassium loss.
• NSAIDs: Increased risk of GI bleeding or ulceration.

Food Interactions: It is unsafe to consume alcohol with Fludrocortisone Acetate.

Use in Pregnancy: Category C; animal studies have shown harmful effects; only use when no alternatives and benefit outweighs risk.

Use in Lactation: No data on excretion into human milk; corticosteroids are distributed into breast milk and could cause growth suppression and/or other adverse effects; caution required.

Pediatric Use: Not FDA-approved; limited information available.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Limited information available; use with caution.

Hepatic Impairment: Limited information available; use with caution.

Overdose: Overdose is unlikely; however, treatment is by supportive and symptomatic therapy.

Storage: Keep below 30 degree C, away from light and moisture. Keep out of reach of children.

Fludrocortisone Acetate