Source: FDA, National Drug Code (US) Revision Year: 2016
1. Endocrine Disorders:
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
2. Rheumatic Disorders:
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, Acute and subacute bursitis, Acute nonspecific tenosynovitis, Acute gouty arthritis
Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis
3. Collagen Diseases:
During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus 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:
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
For Oral Administration.
DOSAGE 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 a 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 patient’s response is satisfactory. If satisfactory clinical response does not occur after a reasonable period of time, discontinue cortisone acetate tablets and transfer the patient to other therapy.
After a 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 a few days of treatment, it usually should be withdrawn gradually.
Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. In the event of overdosage, no specific antidote is available; treatment is supportive and symptomatic.
The intraperitoneal LD50 of cortisone acetate in female mice was 1405 mg/kg.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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