Cortisone acetate is indicated in the following conditions:

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 mineralocor-ticoid supplementation is of particular importance)

Congenital adrenal hyperplasia

Hypercalcemia associated with cancer

Nonsuppurative thyroiditis

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)

Ankylosing spondylitis

Post-traumatic osteoarthritis

Acute and subacute bursitis

Synovitis of osteoarthritis

Acute nonspecific tenosynovitis

Epicondylitis Acute gouty arthritis

During an exacerbation or as maintenance therapy in selected cases of:

Systemic lupus erythematosus

Acute rheumatic carditis

Systemic dermatomyositis (polymyositis)

Pemphigus

Exfoliative dermatitis

Bullous dermatitis herpetiformis

Mycosis fungoides Severe erythema multiforme (Stevens-Johnson syndrome)

Severe psoriasis

Severe seborrheic dermatitis

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment.

Seasonal or perennial allergic rhinitis

Contact dermatitis

Atopic dermatitis

Serum sickness

Drug hypersensitivity reactions

Bronchial asthma

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:

Allergic conjunctivitis

Anterior segment inflammation

Keratitis

Allergic corneal marginal ulcers

Diffuse posterior uveitis and choroiditis

Herpes zoster ophthalmicus

Iritis and iridocyclitis

Optic neuritis

Chorioretinitis

Sympathetic ophthalmia

Symptomatic sarcoidosis

Loeffler’s syndrome not manageable by other means

Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy

Berylliosis

Aspiration pneumonitis

Idiopathic thrombocytopenic purpura in adults

Acquired (autoimmune) hemolytic anemia

Secondary thrombocytopenia in adults

Erythroblastopenia (RBC anemia)

Congenital (erythroid) hypoplastic anemia

For palliative management of:

Leukemias and lymphomas in adults

Acute leukemia of childhood

To induce a diuresis or remission of protein-uria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

To tide the patient over a critical period of the disease in: 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

The initial dosage of cortisone acetate may vary from 25 to 300 mg per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice; while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, cortisone acetate should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of cortisone acetate for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Cortisone Acetate Tablets, USP are available in the following strengths and package sizes:

(white, round, scored, imprinted UPJOHN 15)

Bottles of 50 …………………………………………….. NDC 0009-0015-01

(white, round, scored, imprinted UPJOHN 23)

Bottles of 100 …………………………………………….. NDC 0009-0023-01

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation Kalamazoo, MI 49001, USA, Revised February 2002, 810 931 813 692851

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