ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. Fluid and Electrolyte DisturbancesSodium retentionFluid retentionCongestive heart failure in susceptible patientsPotassium lossHypokalemic alkalosisHypertensionMusculoskeletalMuscle weaknessSteroid myopathyLoss of muscle massOsteoporosisVertebral compression fracturesAseptic necrosis of femoral and humeral headsPathologic fracture of long bonesTendon ruptureGastrointestinalPeptic ulcer with possible perforation and hemorrhagePerforation of the small and large bowel, particularly in patients with inflammatory bowel diseasePancreatitisAbdominal distentionUlcerative esophagitisDermatologicImpaired wound healingThin fragile skinPetechiae and ecchymosesErythemaIncreased sweatingMay suppress reactions to skin testsOther cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edemaNeurologicConvulsionsIncreased intracranial pressure with papilledema (pseudotumor cerbri) usually after treatmentVertigoHeadachePsychic disturbancesEndocrineMenstrual irregularitiesDevelopment of cushingoid stateSuppression of growth in childrenSecondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery, or illnessDecreased carbohydrate toleranceManifestations of latent diabetes mellitusIncreased requirements for insulin or oral hypoglycemic agents in diabeticsHirsutismOphthalmicPosterior subcapsular cataractsIncreased intraocular pressureGlaucomaExophthalmosMetabolicNegative nitrogen balance due to protein catabolismOtherHypersensitivityThromboembolismWeight gainIncreased appetiteNauseaMalaiseTo 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.. Sodium retention. Fluid retention. Congestive heart failure in susceptible patients. Potassium loss. Hypokalemic alkalosis. Hypertension. Muscle weakness. Steroid myopathy. Loss of muscle mass. Osteoporosis. Vertebral compression fractures. Aseptic necrosis of femoral and humeral heads. Pathologic fracture of long bones. Tendon rupture. Peptic ulcer with possible perforation and hemorrhage. Perforation of the small and large bowel, particularly in patients with inflammatory bowel disease. Pancreatitis. Abdominal distention. Ulcerative esophagitis. Impaired wound healing. Thin fragile skin. Petechiae and ecchymoses. Erythema. Increased sweating. May suppress reactions to skin tests. Other cutaneous reactions, such as allergic dermatitis, urticaria, angioneurotic edema. Convulsions. Increased intracranial pressure with papilledema (pseudotumor cerbri) usually after treatment. Vertigo. Headache. Psychic disturbances. 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. Posterior subcapsular cataracts. Increased intraocular pressure. Glaucoma. Exophthalmos. Negative nitrogen balance due to protein catabolism. Hypersensitivity. Thromboembolism. Weight gain. Increased appetite. Nausea. Malaise.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. For Oral AdministrationDOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE AND THE RESPONSE OF THE PATIENT.The initial dosage varies from 25 to 300 mg day depending on the disease being treated. In less severe diseases doses lower than 25 mg may suffice, while in severe diseases doses higher than 300 mg may be required. The initial dosage should be maintained or adjusted until the patients response is satisfactory. If satisfactory clinical response does not occur after reasonable period of time, discontinue cortisone acetate tablets and transfer the patient to other therapy.After favorable initial response, the proper maintenance dosage should be determined by decreasing the initial dosage in small amounts to the lowest dosage that maintains an adequate clinical response.Patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions 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 few days of treatment, it usually should be withdrawn gradually.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. When oral therapy is not feasible:1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).Congenital adrenal hyperplasiaNonsuppurative thyroiditisHypercalcemia associated with cancer2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosusAcute rheumatic carditisSystemic dermatomyositis (polymyositis)4. Dermatologic DiseasesPemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: Allergic conjunctivitisKeratitisAllergic corneal marginal ulcersHerpes zoster ophthalmicusIritis and iridocyclitisChorioretinitisAnterior segment inflammationDiffuse posterior uveitis and choroiditisOptic neuritisSympathetic ophthalmia7. Respiratory DiseasesSymptomatic sarcoidosisLoefflers syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapyAspiration pneumonitis8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adultsAcute leukemia of childhood10. Edematous StatesTo induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus11. Gastrointestinal DiseasesTo tide the patient over critical period of the disease in:Ulcerative colitisRegional enteritis12. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance).. Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute nonspecific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. Systemic lupus erythematosus. Acute rheumatic carditis. Systemic dermatomyositis (polymyositis). Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. Seasonal or perennial allergic rhinitis. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Serum sickness. Drug hypersensitivity reactions. 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. Symptomatic sarcoidosis. Loefflers syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculosis chemotherapy. Aspiration pneumonitis. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. Leukemias and lymphomas in adults. Acute leukemia of childhood. To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. Ulcerative colitis. Regional enteritis. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.

PRECAUTIONS SECTION.

PRECAUTIONS:. General:Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including fever, myalgia, arthralgia, and malaise. This may occur in patients even without evidence of adrenal insufficiency.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 because of possible 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 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.Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.Steroids should be used with caution in nonspecific ulcerative colitis, if there is 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. Signs of peritoneal irritation following gastrointestinal perforation in patients receiving large doses of corticosteroids may be minimal or absent. Fat embolism has been reported as possible complication of hypercortisonism.When large doses are given, some authorities advise that corticosteroids be taken with meals and antacids taken between meals to help to prevent peptic ulcer.Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.Steroids may increase or decrease motility and number of spermatozoa in some patients.Phenytoin, phenobarbital, ephedrine, and rifampin may enhance the metabolic clearance of corticosteroids, resulting in decreased blood levels and lessened physiologic activity, thus requiring adjustment in corticosteroid dosage.The prothrombin time should be checked frequently in patients who are receiving corticosteroids and coumarin anticoagulants at the same time because of reports that corticosteroids have altered the response to these anticoagulants. Studies have shown that the usual effect produced by adding corticosteroids is inhibition of response to coumarins, although there have been some conflicting reports of potentiation not substantiated by studies.When corticosteroids are administered concomitantly with potassium-depleting diuretics, patients should be observed closely for development of hypokalemia.Information for Patients:Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

WARNINGS SECTION.

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.Drug-induced secondary adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and 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. If the patient is receiving steroids already, dosage may have to be increased. Since mineralocorticoid secretion may be impaired, salt and/or mineralocorticoid should be administered concurrently.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. Moreover, corticosteroids may affect the nitroblue-tetrazolium test for bacterial infection and produce false negative results.In cerebral malaria, double-blind trial has shown that the use of corticosteroids is associated with prolongation of coma and 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 Addisons 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 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 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.