Dosing and uses of Florinef, Florinef Acetate (fludrocortisone)
Adult dosage forms and strengths
tablet
- 0.1mg
Adrenocortical Insufficiency/Addison Disease
Primary and secondary adrenocortical insufficiency in Addison disease
Usual, 0.1 mg/day PO; range, 0.1 mg PO 3 times weekly to 0.2 mg/day PO
If hypertension occurs: 0.05 mg/day PO
Salt-Losing Forms of Congenital Adrenogenital Syndrome
0.1-0.2 mg/day PO
Severe Orthostatic Hypotension (Off-label)
0.1 mg/day PO in combination with high salt diet and adequate fluid intake; may be increased in increments of 0.1 mg/wk; not to exceed 1 mg/day
Dosages >0.3 mg/day have not been shown to be beneficial and predispose patient to adverse effects
Pediatric dosage forms and strengths
tablet
- 0.1mg
Not FDA-approved for use in children
Adrenocortical Insufficiency/Addison Disease (Off-label)
0.05-0.1 mg/day PO in single daily dose or divided q12hr in combination with sodium chloride supplementation
Congenital Adrenal Hyperplasia (Off-label)
0.05-0.3 mg/day PO
Florinef, Florinef Acetate (fludrocortisone) adverse (side) effects
Frequency not defined
Acne
Adrenal suppression
Change in spermatogenesis
Delayed wound healing
Diabetes mellitus
GI perforation
Glucose intolerance
Hepatomegaly
Hypokalemic alkalosis
Increased transaminases
Insomnia
Menstrual irregularity
Myopathy
Neuritis
Osteoporosis
Peptic ulcer
Perianal pruritus
Pituitary adrenal axis suppression
Pseudotumor cerebri (on withdrawal)
Psychosis
Seizure
Ulcerative esophagitis
Urticaria
Vertigo
Weight gain
Warnings
Contraindications
Systemic fungal infection
Documented hypersensitivity
Receipt of live or attenuated live vaccine; Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP) state that administration of live virus vaccines usually is not contraindicated in patients receiving corticosteroid therapy as short-term (<2 weeks) treatment, in low-to-moderate dosages, as long-term alternate-day treatment with short-acting preparations, or in maintenance of physiologic dosages (replacement therapy)
Cautions
Use with caution in diabetes mellitus, hypertension, hypothyroidism, electrolyte abnormalities, sodium and water retention, infections, immunizations, ocular herpes simplex, myasthenia gravis, peptic ulcer disease, psychosis, renal insufficiency
Thromboembolic disorders and myopathy may occur
Delayed wound healing is possible
Patients receiving corticosteroids should avoid chickenpox or measles-infected persons if unvaccinated
Latent tuberculosis may be reactivated (patients with positive tuberculin test should be monitored)
Some suggestion (not fully substantiated) of slightly increased cleft palate risk if corticosteroids are used in pregnancy
Prolonged corticosteroid use may result in elevated intraocular pressure, glaucoma, or cataracts and has been associated with development of Kaposi sarcoma
Myopathy has been reported
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether drug is excreted in milk; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Florinef, Florinef Acetate (fludrocortisone)
Mechanism of action
Potent mineralocorticoid with high glucocorticoid activity; promotes increased reabsorption of sodium and excretion of potassium from renal distal tubules
Absorption
Bioavailability: 100%
Peak plasma time: ≤1.7 hr
Distribution
Protein bound: 42%
Metabolism
Metabolized in liver
Elimination
Half-life: Plasma, 3.5 hr; biologic, 18-36 hr
