WARNINGS
In severe ulcerative colitis, it is hazardous to delay
needed surgery while awaiting response to medical treatment.
Damage to the rectal wall can result from careless or
improper insertion of an enema tip.
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 child-bearing potential requires that the possible benefits of the
drug be weighed against the potential hazards to the mother and embryo or
fetus. Neonates born of mothers who have received substantial doses of
corticosteroid during pregnancy should be carefully observed for signs of
hypoadrenalism.
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. 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.
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
pediatric patients or adults on corticosteroids. In such pediatric patients 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.
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.