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Deltasone
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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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination With other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1
These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 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 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.
Administration of live or live, attenuated vaccines is contraindicated in patients
receiving immunosuppressive doses of corticosteroids. Killed or inactivated
vaccines may be administered to patients receiving immunosuppressive doses of
corticosteroids; however, the response to such vaccines may be diminished. Indicated
immunization procedures may be undertaken in patients receiving nonimmunosuppressive
doses of corticosteroids.
The use of DELTASONE (prednisone) 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
anti-tuberculous 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.
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. Similarly, corticosteroids. should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
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 on patients with hypothyroidism
and in those with cirrhosis.
Corticosteroids should be used cautiously in patients with ocular herpes simplex
because of possible cornmeal 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 should
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.
Steroids should be used with caution in nonspecific ulcerative colitis, if
there is a probability of impending perforation, abscess or other pyogenic infection;
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 observed.
Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid
therapy. Discontinuation of corticosteroids may result in clinical remission.
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 the 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.
Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.
REFERENCES
1 Fekety R. Infections associated with corticosteroids and immunosuppressive
therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases.
Philadelphia: WBSaunders Company 1992:1050-1.
2 Stuck AE, Minder CE, Frey FJ. Risk of infectious complications
in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63.
Last reviewed on RxList: 4/20/2007
This monograph has been modified to include the generic and brand name in many instances.
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