ts who discontinue steroids after concurrent high-dose aspirin therapy. monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see precautions, general ). barbiturates, phenytoin, or rifampin —increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly. anabolic steroids (particularly c-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds)—enhanced tendency toward edema. use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. vaccines —neurological complications and lack of antibody response (see warnings ). estrogen —increased levels of corticosteroid-binding globulin thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids. when estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated.

ludrocortisone acetate is a potent mineralocorticoid, both the dosage and salt intake should be carefully monitored in order to avoid the development of hypertension, edema or weight gain. periodic checking of serum electrolyte levels is advisable during prolonged therapy; dietary salt restriction and potassium supplementation may be necessary . all corticosteroids increase calcium excretion. patients should not be vaccinated against smallpox while on corticosteroid therapy. other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. the use of fludrocortisone acetate in patients with active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen. if corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. during prolonged corticosteroid therapy these patients should receive chemoprophylaxis. children who are on immunosuppressant drugs are more susceptible to infections than healthy children. chicken pox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant corticosteroids. in such children, or in adults who have not had these diseases, particular care should be taken to avoid exposure. if exposed, therapy with variicella zoster immune globulin (vzig) or pooled intravenous immunoglobulin (ivig), as appropriate, may be indicated. if chicken pox develops, treatment with antiviral agents may be considered.

y corticosteroids. aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinemia. corticosteroids should be used with caution in patients with nonspecific ulcerative colitis if there is a probability of impending perforation, abscess, or other pyogenic infection. corticosteroids should also be used cautiously in patients with diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis.

es) or hydrocortisone (10 mg to 30 mg daily in divided doses). salt-losing adrenogenital syndrome the recommended dosage for treating the salt-losing adrenogenital syndrome is 0.1 mg to 0.2 mg of fludrocortisone acetate tablets daily.

atologic —impaired wound healing, thin fragile skin, bruising, petechiae and ecchymoses, facial erythema, increased sweating, subcutaneous fat atrophy, purpura, striae, hyperpigmentation of the skin and nails, hirsutism, acneiform eruptions and hives; reactions to skin tests may be suppressed. neurological —convulsions, increased intracranial pressure with papilledema (psuedo-tumor cerebri) usually after treatment, vertigo, headache, and severe mental disturbances. endocrine —menstrual irregularities; development of the cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress (e.g., trauma, surgery, or illness); decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; and increased requirements for insulin or oral hypoglycemic agents in diabetics. ophthalmic —posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos. metabolic —hyperglycemia, glycosuria, and negative nitrogen balance due to protein catabolism. allergic reactions —allergic skin rash, maculopapular rash, and urticaria. other adverse reactions that may occur following the administration of a corticosteroid are necrotizing angiitis, thrombophlebitis, aggravation or masking of infections, insomnia, syncopal episodes, and anaphylactoid reactions. to report suspected adverse reactions, contact amneal pharmaceuticals at 1-877-835-5472 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ts who discontinue steroids after concurrent high-dose aspirin therapy. monitor salicylate levels or the therapeutic effect for which aspirin is given; adjust salicylate dosage accordingly if effect is altered (see precautions, general ). barbiturates, phenytoin, or rifampin —increased metabolic clearance of fludrocortisone acetate because of the induction of hepatic enzymes. observe the patient for possible diminished effect of steroid and increase the steroid dosage accordingly. anabolic steroids (particularly c-17 alkylated androgens such as oxymetholone, methandrostenolone, norethandrolone, and similar compounds)—enhanced tendency toward edema. use caution when giving these drugs together, especially in patients with hepatic or cardiac disease. vaccines —neurological complications and lack of antibody response (see warnings ). estrogen —increased levels of corticosteroid-binding globulin thereby increasing the bound (inactive) fraction; this effect is at least balanced by decreased metabolism of corticosteroids. when estrogen therapy is initiated, a reduction in corticosteroid dosage may be required, and increased amounts may be required when estrogen is terminated.

of physiological activities that are characteristic of mineralocorticoids. in small oral doses, fludrocortisone acetate produces marked sodium retention and increased urinary potassium excretion. it also causes a rise in blood pressure, apparently because of these effects on electrolyte levels. in larger doses, fludrocortisone acetate inhibits endogenous adrenal cortical secretion, thymic activity, and pituitary corticotropin excretion; promotes the deposition of liver glycogen; and, unless protein intake is adequate, induces negative nitrogen balance. the approximate plasma half-life of fludrocortisone (fluorohydrocortisone) is 3.5 hours or more and the biological half-life is 18 to 36 hours.

eadaches, swelling of feet or lower legs, or unusual weight gain. advise the patient to use the medicine only as directed, to take a missed dose as soon as possible, unless it is almost time for the next dose, and not to double the next dose. inform the patient to keep this medication and all drugs out of the reach of children.