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Cytadren

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Cytadren

Cytadren

WARNINGS

Cytadren (aminoglutethimide) may cause adrenocortical hypofunction, especially under conditions of stress, such as surgery, trauma, or acute illness. Patients should be carefully monitored and given hydrocortisone and mineralocorticoid supplements as indicated. Dexamethasone should not be used. (See PRECAUTIONS: DRUG INTERACTIONS.)

Cytadren (aminoglutethimide) also may suppress aldosterone production by the adrenal cortex and may cause orthostatic or persistent hypotension. The blood pressure should be monitored in all patients at appropriate intervals. Patients should be advised of the possible occurrence of weakness and dizziness as symptoms of hypotension, and of measures to be taken should they occur.

The effects of Cytadren (aminoglutethimide) may be potentiated if it is taken in combination with alcohol.

Cytadren (aminoglutethimide) can cause fetal harm when administered to a pregnant woman. In the earlier experience with the drug in about 5000 patients, two cases of pseudohermaphroditism were reported in female infants whose mothers were treated with Cytadren (aminoglutethimide) and concomitant anticonvulsants. Normal pregnancies have also occurred in patients treated with Cytadren (aminoglutethimide) .

When administered to rats at doses 1/2 and 1 1/4 times the maximum daily human dose, Cytadren (aminoglutethimide) caused a decrease in fetal implantation, an increase in fetal deaths, and a variety of teratogenic effects. The compound also caused pseudohermaphroditism in rats treated with approximately 3 times the maximum daily human dose. If this drug must be used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be apprised of the potential hazard to the fetus.

PRECAUTIONS

General

This drug should be administered only by physicians familiar with its use and hazards. Therapy should be initiated in a hospital. (See DOSAGE AND ADMINISTRATION.)

Laboratory Tests

Hypothyroidism may occur in association with Cytadren (aminoglutethimide) ; hence, appropriate clinical observations should be made and laboratory studies of thyroid function performed as indicated. Supplementary thyroid hormone may be required.

Hematologic abnormalities in patients receiving Cytadren have been reported (see ADVERSE REACTIONS). Therefore, baseline hematologic studies should be performed, followed by periodic hematologic evaluation.

Since elevations in SGOT, alkaline phosphatase, and bilirubin have been reported, appropriate clinical observations and regular laboratory studies should be performed before and during therapy.

Serum electrolyte levels should be determined periodically.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 2-year carcinogenicity study of Cytadren (aminoglutethimide) conducted in rats at doses of 10-60 mg/kg/day (approximately 0.04 to 0.2 times the maximum daily therapeutic dose based on surface area, mg/m2) revealed a highly statistically significant dose-related trend in the incidence of benign and malignant neoplasms of the adrenal cortex and thyroid follicular cells in both sexes. A borderline statistically significant increase (0.05 level) in ovarian tubular adenomas was observed at 60 mg/kg/day. Urinary bladder papillomas also showed a statistically significant dose-related trend in males.

Cytadren (aminoglutethimide) affects fertility in female rats (see WARNINGS). The relevance of these findings to humans is not known.

Pregnancy Category D

See WARNINGS.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Cytadren (aminoglutethimide) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established (see Clinical Studies In Children).

Geriatric Use

Clinical studies of Cytadren (aminoglutethimide) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Spontaneous post-marketing adverse event reports and reports from the published literature have not identified obvious differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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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