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Cytadren

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Cytadren

Cytadren

INDICATIONS

Cytadren (aminoglutethimide) is indicated for the suppression of adrenal function in selected patients with Cushing's syndrome. Morning levels of plasma cortisol in patients with adrenal carcinoma and ectopic ACTH-producing tumors were reduced on the average to about one half of the pretreatment levels, and in patients with adrenal hyperplasia to about two thirds of the pretreatment levels, during 1-3 months of therapy with Cytadren (aminoglutethimide) . Data available from the few patients with adrenal adenoma suggest similar reductions in plasma cortisol levels. Measurements of plasma cortisol showed reductions to at least 50% of baseline or to normal levels in one third or more of the patients studied, depending on diagnostic groups and time of measurement.

Because Cytadren (aminoglutethimide) does not affect the underlying disease process, it is used primarily as an interim measure until more definitive therapy such as surgery can be undertaken or in cases where such therapy is not appropriate. Only small numbers of patients have been treated for longer than 3 months. A decreased effect or “escape phenomenon” seems to occur more frequently in patients with pituitary-dependent Cushing's syndrome, probably because of increasing ACTH levels in response to decreasing glucocorticoid levels.

Cytadren (aminoglutethimide) should be used only in those patients who are responsive to treatment.

DOSAGE AND ADMINISTRATION

Adults

Treatment should be instituted in a hospital until a stable dosage regimen is achieved. Therapy should be initiated with 250 mg orally four times daily, preferably at 6-hour intervals. Adrenocortical response should be followed by careful monitoring of plasma cortisol levels until the desired level of suppression is achieved. If the level of cortisol suppression is inadequate, the dosage may be increased in increments of 250 mg daily at intervals of 1-2 weeks to a total daily dose of 2 g. Dose reduction or temporary discontinuation of therapy may be required in the event of adverse effects, including extreme drowsiness, severe skin rash, or excessively low cortisol levels. If a skin rash persists for longer than 5-8 days or becomes severe, the drug should be discontinued. It may be possible to reinstate therapy at a lower dosage following the disappearance of a mild or moderate rash. Mineralocorticoid replacement (e.g., fludrocortisone) may be necessary. If glucocorticoid replacement therapy is needed, 20-30 mg of hydrocortisone orally in the morning will replace endogenous secretion.

HOW SUPPLIED

Tablets 250 mg — white, round, scored into quarters (imprinted CIBA 24)

Bottles of 100 ...................................................... NDC 0083-0024-30

Protect from light.

Do not store above 30C (86F).

Dispense in tight, light-resistant container (USP).

Manufactured by: Patheon Whitby Inc. Whitby Ontario, Canada L1N 5Z5. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA Rev date: 5/7/2003

Last reviewed on RxList: 1/15/2009
This monograph has been modified to include the generic and brand name in many instances.

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