"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
(Generic versions may still be available.)
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)
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)
Synovitis of osteoarthritis
Acute nonspecific tenosynovitis
During an exacerbation or as maintenance therapy in selected cases of:
Acute rheumatic carditis
Bullous dermatitis herpetiformis
Severe seborrheic dermatitis
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment.
Seasonal or perennial allergic rhinitis
Drug hypersensitivity reactions
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Loeffler’s syndrome not manageable by other means
Idiopathic thrombocytopenic purpura in adults
Secondary thrombocytopenia in adults
Congenital (erythroid) hypoplastic anemia
For palliative management of:
Leukemias and lymphomas in adults
Trichinosis with neurologic or myocardial involvement
DOSAGE AND ADMINISTRATION
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 692851This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/6/2005
Additional Cortone Information
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