Fludrocortisone

Adrenal insufficiency, primary (Addison disease): Oral: Initial: 0.05 to 0.1 mg once daily in the morning (in combination with glucocorticoid therapy). Usual maintenance dose: 0.05 to 0.2 mg once daily. If hypertension develops, dose reduction is suggested; an antihypertensive may be necessary if hypertension remains uncontrolled

Congenital adrenal hyperplasia, classic (salt-losing adrenogenital syndrome): Oral: 0.05 to 0.2 mg/day in 1 or 2 divided doses (in combination with glucocorticoid therapy)

Orthostatic hypotension (off-label use): Oral: Initial: 0.05 to 0.1 mg once daily. May adjust dose (eg, in 0.05 to 0.1 mg/day increments) at weekly intervals if needed based on response; usual dose range: 0.05 to 0.2 mg/day administered in 1 or 2 divided daily doses

Postural orthostatic tachycardia syndrome (off-label use):

Oral: Initial: 0.05 to 0.1 mg once daily. May increase slowly based on response and tolerability up to 0.1 to 0.2 mg/day

Contraindications

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

Interactions

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Management: Consider separating doses by 2 or more hours. Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid, with unknown impact on budesonide therapeutic effects. Risk D: Consider therapy modification

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Cladribine: Corticosteroids (Systemic) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Influenza Virus Vaccines: Corticosteroids (Systemic) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiation of systemic corticosteroids at immunosuppressive doses. Influenza vaccines administered less than 14 days prior to or during such therapy should be repeated 3 months after therapy. Risk D: Consider therapy modification

Pregnancy and Lactation

Systemic corticosteroids may influence fetal growth (decreased birth weight); however, information is conflicting.

It is not known if fludrocortisone is excreted in breast milk; corticosteroids are excreted in breast milk. It is recommended that caution should be exercised when administering fludrocortisone to nursing women.

Warning and Precaution

• Adrenal suppression: May cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully.
• Anaphylactoid reactions: rare cases of anaphylactoid reactions have been observed in patients receiving corticosteroids.
• Immunosuppression: Prolonged use may increase risk of infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to killed or inactivated vaccines. Exposure to chickenpox or measles should be avoided. Corticosteroids should not be used for cerebral malaria or viral hepatitis. Close observation is required in patients with latent tuberculosis (TB) and/or TB reactivity. Restrict use in active TB (only fulminating or disseminated TB in conjunction with antituberculosis treatment). Amebiasis should be ruled out in any patient with recent travel to tropic climates or unexplained diarrhea prior to initiation of corticosteroids. Use with extreme caution in patients with Strongyloides infections; hyperinfection, dissemination and fatalities have occurred.
• Myopathy: Acute myopathy has been reported with high-dose corticosteroids, usually in patients with neuromuscular transmission disorders; may involve ocular and/or respiratory muscles; monitor creatine kinase; recovery may be delayed.
• Psychiatric disturbances: Corticosteroid use may cause psychiatric disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression to psychotic manifestation. Preexisting psychiatric conditions may be exacerbated by corticosteroid use.

Adverse Reactions

Cardiomegaly, edema, heart failure, Allergic skin rash, atrophic striae, diaphoresis, ecchymoses, facial erythema, hyperpigmentation (skin and nails), maculopapular rash, skin atrophy, subcutaneous atrophy, urticaria, Cushing syndrome, growth retardation, hirsutism, HPA-axis suppression, hyperglycemia, hypokalemia, Abdominal distention, esophageal ulcer, pancreatitis, peptic ulcer

Storage

Store below 30°C and protect from light and moisture.