"DENVER â€” New data shed more light on the specific risks of congenital birth defects associated with the Graves' disease drug methimazole (MMI) and the timing of the teratogenic effects.
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CORTEF Tablets are 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 mineralocorticoid supplementation is of particular importance)
As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:
Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
Acute and subacute bursitis
Acute nonspecific tenosynovitis
Acute gouty arthritis
Synovitis of osteoarthritis
During an exacerbation or as maintenance therapy in selected cases of:
Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:
Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:
Allergic corneal marginal ulcers
Herpes zoster ophthalmicus
Iritis and iridocyclitis
Anterior segment inflammation
Diffuse posterior uveitis and choroiditis
Loeffler's syndrome not manageable by other means
Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
For palliative management of:
To tide the patient over a critical period of the disease in:
Acute exacerbations of multiple sclerosis
DOSAGE AND ADMINISTRATION
The initial dosage of CORTEF Tablets may vary from 20 mg to 240 mg of hydrocortisone 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, CORTEF 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 CORTEF 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.
In treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective (20 mg of hydrocortisone is equivalent to 5 mg of prednisolone).
CORTEF Tablets are available in the following strengths and package sizes:
5 mg (white, round, scored, imprinted CORTEF 5) Bottles
of 50 NDC 0009-0012-01
10 mg (white, round, scored, imprinted CORTEF 10) Bottles of 100 NDC 0009-0031-01
20 mg (white, round, scored, imprinted CORTEF 20) Bottles of 100 NDC 0009-0044-01
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised: Sep 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/17/2017
Additional Cortef Information
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