CONTRAINDICATIONS
Corticosteroids are contraindicated in patients with systemic fungal infections and in those with a
history of possible or known hypersensitivity to these agents.
WARNINGS
BECAUSE OF ITS MARKED EFFECT ON SODIUM RETENTION, THE USE OF
FLUDROCORTISONE ACETATE IN THE TREATMENT OF CONDITIONS OTHER
THAN THOSE INDICATED HEREIN IS NOT ADVISED.
Corticosteroids may mask some signs of infection, and new infections may appear during their use.
There may be decreased resistance and inability to localize infection when corticosteroids are used.
If an infection occurs during fludrocortisone acetate therapy, it should be promptly controlled by
suitable antimicrobial therapy.
Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with
possible damage to the optic nerves, and may enhance the establishment of secondary ocular
infections due to fungi or viruses.
Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt
and water retention, and increased excretion of potassium. These effects are less likely to occur
with the synthetic derivatives except when used in large doses. However, since fludrocortisone
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 tablets in 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 varicella
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.
PRECAUTIONS
General
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 pyrogenic 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 the Patient
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/Laboratory Test Interactions
Corticosteroids may affect the nitrobluetetrazolium test for bacterial infection and produce
false-negative results.
Carcinogenesis, Mutagenesis, and 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 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.
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.