GENERAL PRECAUTIONS
- Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses.
To avoid drug-induced adrenal insufficiency, supportive ...
GENERAL PRECAUTIONS
Adverse reactions to corticosteroids may be produced by too rapid withdrawal or by continued use of large doses.
To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with fludrocortisone acetate and for a year afterwards.
There is an enhanced corticosteroid effect in patients with hypothyroidism and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.
The lowest possible dose of corticosteroid should be used to control the condition being treated. A gradual reduction in dosage should be made when possible.
Psychic derangements may appear when corticosteroids are used. These may range from euphoria, insomnia, mood swings, personality changes, and severe depression to frank psychotic manifestations. Existing emotional instability or psychotic tendencies may also be aggravated by 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.
INFORMATION FOR PATIENTS
The physician should advise the patient to report any medical history of heart disease, high blood pressure, or kidney or liver disease and to report current use of any medicines to determine if these medicines might interact adversely with fludrocortisone acetate (see Drug Interactions).
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice.
The patient’s understanding of his steroid-dependent status and increased dosage requirement under widely variable conditions of stress is vital. Advise the patient to carry medical identification indicating his dependence on steroid medication and, if necessary, instruct him to carry an adequate supply of medication for use in emergencies.
Stress to the patient the importance of regular follow-up visits to check his progress and the need to promptly notify the physician of dizziness, severe or continuing headaches, 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.
LABORATORY TESTS
Patients should be monitored regularly for blood pressure determinations and serum electrolyte determinations (see WARNINGS).
DRUG INTERACTIONS
When administered concurrently, the following drugs may interact with adrenal corticosteroids.
Amphotericin B or potassium-depleting diuretics (benzothiadiazines and related drugs, ethacrynic acid and furosemide)—enhanced hypokalemia. Check serum potassium levels at frequent intervals; use potassium supplements if necessary (see WARNINGS).
Digitalis glycosides— enhanced possibility of arrhythmias or digitalis toxicity associated with hypokalemia. Monitor serum potassium levels; use potassium supplements if necessary.
Oral anticoagulants— decreased prothrombin time response. Monitor prothrombin levels and adjust anticoagulant dosage accordingly.
Antidiabetic drugs (oral agents and insulin)—diminished antidiabetic effect. Monitor for symptoms of hyperglycemia; adjust dosage of antidiabetic drug upward if necessary.
Aspirin— increased ulcerogenic effect; decreased pharmacologic effect of aspirin. Rarely salicylate toxicity may occur in patients 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.
DRUG & OR LABORATORY TEST INTERACTIONS
Corticosteroids may affect the nitroblue tetrazolium test for bacterial infection and produce false- negative results.
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Adequate studies have not been performed in animals to determine whether fludrocortisone acetate has carcinogenic or mutagenic activity or whether it affects fertility in males or females.
PREGNANCY
Teratogenic Effects: Category C
Adequate animal reproduction studies have not been conducted with fludrocortisone acetate. However, many corticosteroids have been shown to be teratogenic in laboratory animals at low doses. Teratogenicity of these agents in man has not been demonstrated. It is not known whether fludrocortisone acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Fludrocortisone acetate should be given to a pregnant woman only if clearly needed.
Pregnancy: Nonteratogenic Effects
Infants born of mothers who have received substantial doses of fludrocortisone acetate during pregnancy should be carefully observed for signs of hypoadrenalism.
Maternal treatment with corticosteroids should be carefully documented in the infant’s medical records to assist in follow up.
NURSING MOTHERS
Corticosteroids are found in the breast milk of lactating women receiving systemic therapy with these agents. Caution should be exercised when fludrocortisone acetate is administered to a nursing woman.
PEDIATRIC USE
Safety and effectiveness in children have not been established.
Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.
GERIATRIC USE
Elderly subjects may commonly have conditions that may be exacerbated by fludrocortisone therapy including, but not limited to, hypertension, edema, hypokalemia, congestive heart failure, cataracts, glaucoma, increased intraocular pressure, renal insufficiency, and osteoporosis (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS). Elderly subjects may also commonly be taking concomitant drug therapy such as digitalis glycosides, oral anticoagulants, antidiabetic drugs (oral agents and insulin), and aspirin which may interact with fludrocortisone (see PRECAUTIONS - Drug Interactions).
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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