Drug: Cytadren

Cytadren, aminoglutethimide tablets USP, is an inhibitor of adrenocortical steroid synthesis, available as 250-mg tablets for oral administration. Its chemical name is 3-(4-aminophenyl)-3-ethyl-2,6-piperidinedione, and its structural formula is Aminoglutethimide USP is a fine, white or creamy white, crystalline powder. It is very slightly soluble in water, and readily soluble in most organic solvents. It forms water- soluble salts with strong acids. Its molecular weight is 232.28. Inactive Ingredients. Cellulose compounds, colloidal silicon dioxide, starch, stearic acid, and talc.Last reviewed on RxList: 1/15/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Untoward effects have been reported in about 2 out of 3 patients with Cushing's syndrome who were treated for 4 or more weeks with Cytadren (aminoglutethimide) as the only adrenocortical suppressant. The most frequent and reversible side effects were drowsiness (approximately 1 in 3 patients), morbilliform skin rash (1 in 6 patients), nausea and anorexia (each approximately 1 in 8 patients), and dizziness (about 1 in 20 patients). The dizziness was possibly caused by lowered vascular resistance or orthostasis. These reactions often disappear spontaneously with continued therapy. Other Effects Observed Hematologic: Single instances of neutropenia, leukopenia (patient received concomitant o,p'-DDD), pancytopenia (patient received concomitant 5-fluorouracil), and agranulocytosis occurred in 4 of 27 patients with Cushing's syndrome caused by adrenal carcinoma who were treated for at least 4 weeks. In 1 patient with adrenal hyperplasia, hemoglobin levels and hematocrit decreased during the course of treatment with Cytadren (aminoglutethimide) . From the earlier experience with the drug used as an anticonvulsant in 1,214 patients, transient leukopenia was the only hematologic effect and was reported once; Coombs'-negative hemolytic anemia also occurred once. In approximately 300 patients with nonadrenal malignancy, 1 in 25 showed some degree of anemia, and 1 in 150 developed pancytopenia during treatment with Cytadren (aminoglutethimide) . Endocrine: Adrenal insufficiency occurred in about 1 in 30 patients with Cushing's syndrome who were treated with Cytadren (aminoglutethimide) for 4 or more weeks. This insufficiency tended to involve glucocorticoids as well as mineralocorticoids. Hypothyroidism is occasionally associated with thyroid enlargement and may be detected or confirmed by measuring plasma levels of the thyroid hormone. Masculinization and hirsutism have occasionally occurred in females, as has precocious sexual development in males. Central Nervous System: Headache was reported in about 1 in 20 patients. Cardiovascular: Hypotension, occasionally orthostatic, occurred in 1 in 30 patients receiving Cytadren (aminoglutethimide) . Tachycardia occurred in 1 in 40 patients. Gastrointestinal and Liver: Vomiting occurred in 1 in 30 patients. Isolated instances of abnormal findings on liver function tests were reported. Suspected hepatotoxicity occurred in less than 1 in 1000 patients. Skin: In addition to rash (1 in 6 patients, and often reversible with continued therapy), pruritus was reported in 1 in 20 patients. These may be allergic or hypersensitive reactions. Urticaria has occurred rarely. Miscellaneous: Fever was reported in several patients who were treated with Cytadren (aminoglutethimide) for less than 4 weeks; some of these patients also received other drugs. Myalgia occurred in 1 in 30 patients. Pulmonary hypersensitivity, including allergic alveolitis and interstitial alveolar infiltrates, has occurred rarely. Read the Cytadren (aminoglutethimide) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.

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Cytadren (aminoglutethimide) accelerates the metabolism of dexamethasone; therefore, if glucocorticoid replacement is needed, hydrocortisone should be prescribed. Aminoglutethimide diminishes the effect of coumarin and warfarin. Last reviewed on RxList: 1/15/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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.

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Cytadren (aminoglutethimide) is contraindicated in those patients with serious forms, and/or more severe manifestations, of hypersensitivity to glutethimide or aminoglutethimide. Last reviewed on RxList: 1/15/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Acute Toxicity No deaths due to overdosage with Cytadren (aminoglutethimide) have been reported. The highest known doses that have been survived are 7 g (33-year-old woman), 7.5-10 g (16-year-old girl), and 10 g (10-year-old boy). Oral LD50's (mg/kg): rats, 1800; dogs, > 100. Intravenous LD50's (mg/kg): rats, 156; dogs, > 100. Signs and Symptoms An acute overdose with Cytadren (aminoglutethimide) may reduce the production of steroids in the adrenal cortex to a degree that is clinically relevant. The following manifestations may be expected: Respiratory Function: Respiratory depression, hypoventilation. Cardiovascular System: Hypotension, hypovolemic shock due to dehydration. Central Nervous System/Muscles: Somnolence, lethargy, coma, ataxia, dizziness, fatigue. (Extreme weakness has been reported with divided doses of 3 g daily.) Gastrointestinal System: Nausea, vomiting. Renal Function: Loss of sodium and water. Laboratory Findings: Hyponatremia, hypochloremia, hyperkalemia, hypoglycemia. The signs and symptoms of acute overdosage with Cytadren (aminoglutethimide) may be aggravated or modified if alcohol, hypnotics, tranquilizers, or tricyclic antidepressants have been taken at the same time. Treatment Symptomatic treatment of overdosage is recommended. Since aminoglutethimide and glutethimide are chemically related, measures that have been used in successfully removing glutethimide from the body might be useful in removing aminoglutethimide. Gastric lavage and unspecified supportive treatment have been employed. Full consciousness following deep coma was regained 40 hours or less after ingestion of 3 or 4 g without lavage. No evidence of hematologic, renal, or hepatic effects was subsequently found. Close monitoring should be provided, and appropriate measures taken to support vital functions, if necessary. If deficiency of circulating glucocorticoid develops, an intravenous infusion of a soluble hydrocortisone preparation (100 mg of hydrocortisone sodium succinate in 500 mL of isotonic sodium chloride solution) and 50 mL of 40% glucose solution should be given within 3 hours. After the initial infusion is completed, an intravenous administration of hydrocortisone, 10 mg per hour, should be continued until the patient is able to take oral cortisone. If hypovolemia or hypotension occurs, an intravenous administration of norepinephrine, 10 mg, in 500 mL of isotonic sodium chloride should be administered according to the patient's needs and response. After rehydration, 500 mL of plasma or blood should be given for maintenance of sufficient circulatory volume. Dialysis may be considered in severe intoxication.

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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 30ºC (86ºF). 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.

Source: http://www.rxlist.com

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.

Source: http://www.rxlist.com

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