WARNINGS
In patients on corticosteroid therapy subjected to
unusual stress, increased dosage of rapidly acting corticosteroids
before, during, and after the stressful situation is indicated.
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.
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.
Usage in pregnancy
. Since adequate human
reproduction studies have not been done with corticosteroids, the
use of these drugs in pregnancy, nursing mothers, or women of childbearing
potential requires that the possible benefits of the drug be weighed
against the potential hazards to the mother and embryo or fetus. Infants
born of mothers who have received substantial doses of corticosteroids
during pregnancy should be carefully observed for signs of hypoadrenalism.
Average and large doses of hydrocortisone 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. Dietary salt restriction
and potassium supplementation may be necessary. All corticosteroids
increase calcium excretion.
While on corticosteroid therapy patients should not
be vaccinated against smallpox. 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 A-Hydrocort sterile powder 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 appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent
tuberculosis or tuberculin reactivity, close observation is necessary
as reactivation of the disease may occur. During prolonged corticosteroid
therapy, these patients should receive chemoprophylaxis.
Because rare instances of anaphylactoid reactions (eg,
bronchospasm) have occurred in patients receiving parenteral corticosteroid
therapy, appropriate precautionary measures should be taken prior
to administration, especially when the patient has a history of allergy
to any drug.
Persons who are on drugs which
suppress the immune system are more susceptible to infections than
healthy individuals. Chicken pox and measles, for example, can have
a more serious or even fatal course in non-immune children or adults
on corticosteroids. In such children or adults who have not had these
diseases, particular care should be taken to avoid exposure. How the
dose, route and duration of corticosteroid administration affects
the risk of developing a disseminated infection is not known. The
contribution of the underlying disease and/or prior corticosteroid
treatment to the risk is also not known. If exposed to chicken pox,
prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin
(IG) may be indicated. (See the respective package inserts for complete
VZIG and IG prescribing information.) If chicken pox develops, treatment
with antiviral agents may be considered.
PRECAUTIONS
General Precautions
Drug-induced secondary adrenocortical insufficiency
may be minimized by gradual reduction of dosage. This type of relative
insufficiency may persist for months after discontinuation of therapy;
therefore, in any situation of stress occurring during that period,
hormone therapy should be reinstituted. Since mineralocorticoid secretion
may be impaired, salt and/or a mineralocorticoid should be administered
concurrently.
There is an enhanced effect of
corticosteroids in patients with hypothyroidism and in those with
cirrhosis.
Corticosteroids should be used cautiously
in patients with ocular herpes simplex for fear of corneal perforation.
The lowest possible dose of corticosteroid should be used
to control the condition under treatment, and when reduction in dosage
is possible, the reduction must be gradual.
Psychic derangements may appear when corticosteroids are used, ranging
from euphoria, insomnia, mood swings, personality changes, and severe
depression, to frank psychotic manifestations. Also, existing emotional
instability or psychotic tendencies may be aggravated by corticosteroids.
Aspirin should be used cautiously in conjunction with
corticosteroids in hypoprothrombinemia.
Steroids
should be used with caution in nonspecific ulcerative colitis, if
there is a probability of impending perforation, abscess or other
pyogenic infection, also in diverticulitis, fresh intestinal anastomoses,
active or latent peptic ulcer, renal insufficiency, hypertension,
osteoporosis, and myasthenia gravis.
Growth
and development of infants and children on prolonged corticosteroid
therapy should be carefully followed.
Although
controlled clinical trials have shown corticosteroids to be effective
in speeding the resolution of acute exacerbations of multiple sclerosis,
they do not show that corticosteroids affect the ultimate outcome
or natural history of the disease. The studies do show that relatively
high doses of corticosteroids are necessary to demonstrate a significant
effect. (See
DOSAGE AND ADMINISTRATION
).
Since complications of treatment with glucocorticoids are dependent
on the size of the dose and duration of treatment, a risk/benefit
decision must be made in each individual case as to dose and duration
of treatment and as to whether daily or intermittent therapy should
be used.
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