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Pronunciation:

(floo droe KOR ti sone)

U.S. Brand Names:

Florinef®

Synonyms:

Fludrocortisone Acetate; Fluohydrisone Acetate; Fluohydrocortisone Acetate; 9-Fluorohydrocortisone Acetate

Generic Available:

Yes

Canadian Brand Names:

Florinef®

Use:

Partial replacement therapy for primary and secondary adrenocortical insufficiency in Addison's disease; treatment of salt-losing adrenogenital syndrome

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown

Contraindications:

Hypersensitivity to fludrocortisone or any component of the formulation; systemic fungal infections

Warnings/Precautions:

Taper dose gradually when therapy is discontinued; use with caution with Addison's disease, sodium retention and potassium loss

Adverse Reactions:

Frequency not defined.

Cardiovascular: Hypertension, edema, CHF

Central nervous system: Convulsions, headache, dizziness

Dermatologic: Acne, rash, bruising

Endocrine & metabolic: Hypokalemic alkalosis, suppression of growth, hyperglycemia, HPA suppression

Gastrointestinal: Peptic ulcer

Neuromuscular & skeletal: Muscle weakness

Ocular: Cataracts

Miscellaneous: Diaphoresis, anaphylaxis (generalized)

Overdosage/Toxicology:

Symptoms of overdose include hypertension, edema, hypokalemia, excessive weight gain. When consumed in excessive quantities, systemic hypercorticism and adrenal suppression may occur. In those cases, discontinuation of the corticosteroid should be done judiciously.

Drug Interactions:

Decreased effect:

Anticholinesterases effects are antagonized

Decreased corticosteroid effects by rifampin, barbiturates, and hydantoins

Decreased salicylate levels

Mechanism of Action:

Promotes increased reabsorption of sodium and loss of potassium from renal distal tubules

Pharmacodynamics/Kinetics:

Absorption: Rapid and complete

Protein binding: 42%

Metabolism: Hepatic

Half-life elimination, plasma: 30-35 minutes; Biological: 18-36 hours

Time to peak, serum: ~1.7 hours

Dosage:

Oral:

Infants and Children: 0.05-0.1 mg/day

Adults: 0.1-0.2 mg/day with ranges of 0.1 mg 3 times/week to 0.2 mg/day

Addison's disease: Initial: 0.1 mg/day; if transient hypertension develops, reduce the dose to 0.05 mg/day. Preferred administration with cortisone (10-37.5 mg/day) or hydrocortisone (10-30 mg/day).

Salt-losing adrenogenital syndrome: 0.1-0.2 mg/day

Administration:

Administration in conjunction with a glucocorticoid is preferable

Monitoring Parameters:

Monitor blood pressure and signs of edema when patient is on chronic therapy; very potent mineralocorticoid with high glucocorticoid activity; monitor serum electrolytes, serum renin activity, and blood pressure; monitor for evidence of infection; stop treatment if a significant increase in weight or blood pressure, edema, or cardiac enlargement occurs

Dietary Considerations:

Systemic use of mineralocorticoids/corticosteroids may require a diet with increased potassium, vitamins A, B6, C, D, folate, calcium, zinc, and phosphorus, and decreased sodium. With fludrocortisone, a decrease in dietary sodium is often not required as the increased retention of sodium is usually the desired therapeutic effect.

Patient Education:

Take exactly as directed. Do not take more than prescribed dose and do not discontinue abruptly; consult prescriber. Take with or after meals. Take once-a-day dose with food in the morning. Limit intake of caffeine or stimulants. Maintain adequate nutrition; consult prescriber for possibility of special dietary recommendations. If you have diabetes, monitor serum glucose closely and notify prescriber of changes; this medication can alter glycemic response. Notify prescriber if you are experiencing higher than normal levels of stress; medication may need adjustment. Periodic ophthalmic examinations will be necessary with long-term use. You will be susceptible to infection (avoid crowds and exposure to infection). You may experience insomnia or nervousness; use caution when driving or engaging in tasks requiring alertness until response to drug is known. Report weakness, change in menstrual pattern, vision changes, signs of hyperglycemia, signs of infection (eg, fever, chills, mouth sores, perianal itching, vaginal discharge), other persistent side effects, or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Additional Information:

In patients with salt-losing forms of congenital adrenogenital syndrome, use along with cortisone or hydrocortisone. Fludrocortisone 0.1 mg has sodium retention activity equal to DOCA® 1 mg.

Anesthesia and Critical Care Concerns/Other Considerations:

In patients with salt-losing forms of congenital adrenogenital syndrome, use along with cortisone or hydrocortisone. Fludrocortisone 0.1 mg has sodium retention activity equal to DOCA® 1 mg.

Adrenal Insufficiency: Patients on long-term steroid supplementation will require higher corticosteroid doses when subject to stress (ie, trauma, surgery, severe infection). This agent has significant mineralocorticoid activity with consequent hemodynamic effects. Fludrocortisone has been used to treat severe orthostatic hypotension. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia. A recent randomized, double-blind, placebo controlled trial assessed whether low dose corticosteroid administration could improve 28-day survival in patients with septic shock and acquired adrenal insufficiency. A lack of adrenal reserves is defined by an increase in serum cortisol of 9 mcg/dL in response to corticotropin administration. Cortisol levels were drawn immediately before corticotropin administration and 30 to 60 minutes afterwards. Three hundred adult septic shock patients requiring mechanical ventilation and vasopressor support were randomized to either hydrocortisone (50 mg IVP every 6 hours) and fludrocortisone (50 mcg tablet daily via nasogastric tube) or matching placebos for 7 days. Patients included had severe sepsis requiring vasopressor support and mechanical ventilation. In patients who did not appropriately respond to corticotropin (nonresponders), there were significantly fewer deaths in the active treatment group. Vasopressor therapy was withdrawn more frequently in this subset of the active treatment group. Adverse events were similar in both groups. Patients who lack adrenal reserve and thus have acquired adrenal insufficiency during the stress of septic shock may benefit from physiologic steroid replacement. Further study is required to better characterize the patient populations who may benefit.

Cardiovascular Considerations:

Long-term steroid therapy is associated with fluid retention and hypertension. This agent has some mineralocorticoid activity with consequent hemodynamic effects. Fludrocortisone has been used to treat severe orthostatic hypotension. Patients will often have steroid-induced adverse effects on glucose tolerance and lipid profiles. In discontinuing steroid therapy in patients on long-term steroid supplementation, it is important that steroid therapy be discontinued gradually. Abrupt withdrawal may result in adrenal insufficiency with hypotension and hyperkalemia.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause dizziness

Mental Health: Effects on Psychiatric Treatment:

Barbiturates and carbamazepine may decrease corticosteroid effects; useful in the management of psychotropic-induced hypotension

Dosage Forms:

Tablet, as acetate: 0.1 mg

International Brand Names:

Astonin® (DE); Astonin-H® (AT, DE, HR, HU, LU, RO); Astonin Merck® (ES); Florinef® (CA); Lonikan® (AR)

References

Abraham E and Evans T, "Corticosteroids and Septic Shock (editorial),"JAMA, 2002, 288(7):886-7.

Annane D, Sebille V, Charpentier C, et al, "Effect of Treatment With Low Doses of Hydrocortisone and Fludrocortisone on Mortality in Patients With Septic Shock,"JAMA, 2002, 288(7):862-71.

Coursin DB and Wood KE, "Corticosteroid Supplementation for Adrenal Insufficiency,"JAMA, 2002, 287(2):236-40.

Cooper MS and Stewart PM, "Corticosteroid Insufficiency in Acutely Ill Patients,"N Engl J Med, 2003, 348(8):727-34.

Hotchkiss RS and Karl IE, "The Pathophysiology and Treatment of Sepsis,"N Engl J Med, 2003, 348(2):138-50.

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