erythematosus acute rheumatic carditis systemic dermatomyositis (polymyositis) 4. dermatologic diseases pemphigus bullous dermatitis herpetiformis severe erythema multiforme (stevens-johnson syndrome) exfoliative dermatitis mycosis fungoides severe psoriasis severe seborrheic dermatitis 5. allergic states control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: seasonal or perennial allergic rhinitis bronchial asthma contact dermatitis atopic dermatitis serum sickness drug hypersensitivity reactions 6. ophthalmic diseases severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis keratitis allergic corneal marginal ulcers herpes zoster ophthalmicus iritis and iridocyclitis chorioretinitis anterior segment inflammation diffuse posterior uveitis and choroiditis optic neuritis sympathetic ophthalmia 7. respiratory diseases symptomatic sarcoidosis loeffler’s syndrome not manageable by other means berylliosis fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy aspiration pneumonitis 8. hematologic disorders idiopathic thrombocytopenic purpura in adults secondary thrombocytopenia in adults acquired (autoimmune) hemolytic anemia erythroblastopenia (rbc anemia) congenital (erythroid) hypoplastic anemia 9. neoplastic diseases for palliative management of: leukemias and lymphomas in adults acute leukemia of childhood 10. edematous states to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 11. gastrointestinal diseases to tide the patient over a critical period of the disease in: ulcerative colitis regional enteritis 12. miscellaneous tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy trichinosis with neurologic or myocardial involvement

ue-tetrazolium test for bacterial infection and produce false negative results. in cerebral malaria, a double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and a higher incidence of pneumonia and gastrointestinal bleeding. corticosteroids may activate latent amebiasis. therefore, it is recommended that latent or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has time in the tropics or any patient with unexplained diarrhea. prolonged use of corticosteroids may produce posterior subsapsular 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. dietary salt restriction and potassium supplementation may be necessary. all corticosteroids increase calcium excretion. administration of live virus vaccines, including smallpox, is contraindicated in individuals receiving immunosuppressive doses of corticosteroids. if inactivated viral or bacterial vaccines are administered to individuals receiving immunosuppressive doses of corticosteroids, the expected serum antibody response may not be obtained. however, immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g., for addison’s disease. persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. chickenpox and measles, for example, can have 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 chickenpox, 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 chickenpox develops, treatment with antiviral agents may be considered. the use of cortisone 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 as reactivation of the disease may occur. during prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. usage in pregnancy: since adequate human reproduction studies have not been done with corticosteroids, use of these drugs in pregnancy or in women of childbearing potential requires that the anticipated benefits be weighed against the possible 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 appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects. mothers taking pharmacologic doses of corticosteroids should be advised not to nurse.

issions or exacerbations of the disease, individual drug responsiveness, and the effect of stress (e.g., surgery, infection, trauma). during stress it may be necessary to increase dosage temporarily. if the drug is to be stopped after more than a few days of treatment, it usually should be withdrawn gradually.

rbances endocrine menstrual irregularities development of cushingoid state suppression of growth in children secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illness decreased carbohydrate tolerance manifestations of latent diabetes mellitus increased requirements for insulin or oral hypoglycemic agents in diabetics hirsutism ophthalmic posterior subcapsular cataracts increased intraocular pressure glaucoma exophthalmos metabolic negative nitrogen balance due to protein catabolism other hypersensitivity thromboembolism weight gain increased appetite nausea malaise to report suspected adverse reactions, contact chartwell rx, llc. corp. at 1-845-232-1683, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.