Fludrocortisone Acetate

Fludrocortisone, a corticosteroid, is used to help control the amount of sodium and fluids in your body. It is used to treat Addison's disease and syndromes where excessive amounts of sodium are lost in the urine. It works by decreasing the amount of sodium that is lost (excreted) in your urine.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Fludrocortisone is also used to increase blood pressure. Talk to your doctor about the possible risks of using this drug for your condition.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Used for oral mineralocorticoid replacement therapy; use is contraindicated in all conditions except those that require a high degree of mineralocorticoid activity.b

Adrenocortical Insufficiency

Partial replacement therapy, in combination with hydrocortisone or cortisone, for treatment of primary and secondary adrenocortical insufficiency in Addison’s disease after electrolyte balance has been restored.a b

Hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy; concomitant administration of fludrocortisone may be required in some patients.

Adrenogenital Syndrome

Treatment of salt-losing congenital adrenogenital syndrome after electrolyte balance has been restored.a b

Postural Hypotension

Has been used with some success to increase SBP and DBP in patients with severe, chronic postural hypotension† (e.g., secondary to autonomic dysfunction, levodopa therapy) that does not respond adequately to nondrug therapy.b

General

• Dosage depends on the severity of the disease and patient response.a b

• Titrate dosage to the lowest effective level.a Gradually reduce dosage when possible.a

• Patients should be continually monitored for signs that indicate dosage adjustment is necessary (e.g., remissions or exacerbations of the disease, stress [surgery, infection, trauma]).a b

Administration

Oral Administration

Administer orally.a b

Manufacturer makes no specific recommendations regarding administration with meals.a

Dosage

Available as fludrocortisone acetate; dosage expressed in terms of the salt.a

Adults

Usually, 0.1 mg daily; dosage may range from 0.1 mg 3 times weekly to 0.2 mg daily.a b

If hypertension occurs, reduce dosage to 0.05 mg daily.a b

Administer concomitantly with cortisone (10–37.5 mg daily in divided doses) or hydrocortisone (10–30 mg daily in divided doses).a b

0.1–0.2 mg daily.a b

0.1–0.4 mg daily has been given to diabetic patients with postural hypotension†.b

0.05–0.2 mg daily has been given to patients with postural hypotension secondary to levodopa therapy†.b

Prescribing Limits

Adults

Maximum 0.2 mg daily.a b

Maximum 0.2 mg daily.a b

Special Populations

Hepatic Impairment

No special population dosage recommendations at this time.a

Renal Impairment

No special population dosage recommendations at this time.a

Geriatric Patients

Careful dosage selection recommended due to possible age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.a

Contraindications

• Systemic fungal infections.a

• Known hypersensitivity to fludrocortisone or any ingredient in the formulation.a

Warnings/Precautions

Warnings

When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause decreased secretion of endogenous corticosteroids by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).a c

The degree and duration of adrenocortical insufficiency is highly variable among patients and depends on the dose, frequency and time of administration, and duration of glucocorticoid therapy.c

Withdraw fludrocortisone gradually following long-term therapy with pharmacologic dosages.a c

Adrenal suppression may persist up to 12 months in patients who receive large dosages for prolonged periods.a c

Until recovery occurs, signs and symptoms of adrenal insufficiency may develop if subjected to stress (e.g., infection, surgery, trauma), and replacement therapy may be required.a

Increased susceptibility to infections secondary to glucocorticoid-induced immunosuppression.a Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.a (See Increased Susceptibility to Infection under Warnings.)

Administration of live virus vaccines, including smallpox, is contraindicated in patients receiving immunosuppressive dosages of glucocorticoids.a If inactivated viral or bacterial vaccines are administered to such patients, the expected serum antibody response may not be obtained.a

Glucocorticoids, especially in large doses, increase susceptibility to and mask symptoms of infection.a

Infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections in any organ system, may be associated with glucocorticoids alone or in combination with other immunosuppressive agents.a c

Infections may be mild, but they can be severe or fatal, and localized infections may disseminate.c

Do not use, except in life-threatening situations, in patients with viral infections or bacterial infections not controlled by anti-infectives.c

Some infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome, particularly in children.a c

Children and any adult who are not likely to have been exposed to varicella or measles should avoid exposure to these infections while receiving glucocorticoids.a

If exposure to varicella or measles occurs in susceptible patients, treat appropriately (e.g., VZIG, IG, acyclovir).a

Fatal outcome (e.g., in those developing hemorrhagic varicella) may not always be avoided even if appropriate therapy is initiated aggressively.c

Can reactivate tuberculosis.a Include chemoprophylaxis in patients with a history of active tuberculosis undergoing prolonged glucocorticoid therapy.a Observe closely for evidence of reactivation.a Restrict use in active tuberculosis to those with fulminating or disseminated tuberculosis in which glucocorticoids are used in conjunction with appropriate chemoprophylaxis.a

Marked sodium retention with resultant edema, potassium loss, and elevation of BP may occur with small doses of fludrocortisone.a Edema and CHF (in susceptible patients) may occur.a

During long-term therapy, perform periodic electrolyte evaluations.a c

Dietary salt restriction is advisable, and potassium supplementation may be necessary.a

Increased calcium excretion and possible hypocalcemia.a

Prolonged use may result in posterior subcapsular cataracts, exophthalmos, and/or increased IOP which may result in glaucoma or may occasionally damage the optic nerve.a c

May enhance the establishment of secondary fungal and viral infections of the eye.a

Use with caution in patients with active ocular herpes simplex infections for fear of corneal perforation.a

General Precautions

During therapy, perform periodic electrolyte and BP evaluations.a (See Fluid and Electrolyte Disturbances under Cautions.)

Administration over a prolonged period may produce various endocrine disorders, including hypercorticism (cushingoid state) or menstrual difficulties; decrease glucose tolerance; produce hyperglycemia; or aggravate or precipitate diabetes mellitus.a c

If glucocorticoid therapy is required in patients with diabetes mellitus, changes in insulin or oral antidiabetic agent dosage or diet may be necessary.b

Exaggerated response to glucocorticoids in hypothyroidism.a

Muscle weakness, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones may occur during prolonged therapy with glucocorticoids.a c These adverse effects may be especially serious in geriatric or debilitated patients.c

Use with caution in patients with osteoporosis or myasthenia gravis.a

May precipitate mental disturbances ranging from euphoria, insomnia, mood swings, depression and anxiety, and personality changes to frank psychoses.a Use may aggravate emotional instability or psychotic tendencies.a

Corticosteroids should be used with caution in patients with diverticulitis, nonspecific ulcerative colitis (if there is a probability of impending perforation, abscess, or other pyogenic infection), recent intestinal anastomoses, or active or latent peptic ulcer.a

Specific Populations

Category C.a

Glucocorticoids are distributed into milk.a Caution if used in nursing women.a

Safety and efficacy not established.a

With long-term use, may delay growth and maturation in children and adolescents.c Monitor carefully the growth and development of pediatric patients receiving prolonged corticosteroid therapy.c Titrate dosage to the lowest effective level.c

With prolonged therapy, muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones may occur.a c May be especially serious in geriatric or debilitated patients.a c

Use with caution due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.a

Exaggerated glucocorticoid response in patients with cirrhosis.a

Use with caution in patients with renal insufficiency.a

Common Adverse Effects

Hypertension, edema, cardiac enlargement, CHF, potassium loss, hypokalemic alkalosis.a

Specific Drugs

Absorption

Bioavailability

Readily absorbed after oral administration.c

Distribution

Extent

Most corticosteroids are rapidly removed from the blood and distributed to muscles, liver, skin, intestines, and kidneys.c Corticosteroids cross the placenta and are distributed into milk.a

Elimination

Metabolism

Metabolized in most tissues, but primarily in the liver, to biologically inactive compounds.a

Half-life

Plasma half-life is ≥3.5 hours.a Biologic half-life is 18–36 hours.a