Systemic fungal infections and known hypersensitivity to components

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Immunosuppression and Increased Risk of Infection

Corticosteroids, including CORTEF, suppress the immune system and increase the risk of

infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic

pathogens. Corticosteroids can:

Corticosteroid-associated infections can be mild but can be severe and at times fatal. The

rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider CORTEF withdrawal or dosage

If CORTEF is used to treat a condition in patients with latent tuberculosis or tuberculin

reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for

reactivation. During prolonged CORTEF therapy, patients with latent tuberculosis or

tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections

Varicella and measles can have a serious or even fatal course in non-immune patients

taking corticosteroids, including CORTEF. In corticosteroid-treated patients who have

not had these diseases or are non-immune, particular care should be taken to avoid

Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including CORTEF. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with CORTEF. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections

Corticosteroids, including CORTEF, may exacerbate systemic fungal infections; therefore, avoid CORTEF use in the presence of such infections unless CORTEF is needed to control drug reactions. For patients on chronic CORTEF therapy who develop systemic fungal infections, CORTEF withdrawal or dosage reduction is recommended.

Amebiasis

Corticosteroids, including CORTEF, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating CORTEF in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation

Corticosteroids, including CORTEF, 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.

Cerebral Malaria

Avoid corticosteroids, including CORTEF, in patients with cerebral malaria.

Ophthalmic Effects

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.

Kaposi's Sarcoma

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi's sarcoma.

Hypertension, Volume Overload, and Hypokalemia

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.

Vaccinations

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.

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. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Corticosteroids have been shown to impair fertility in male rats.