Use in pregnancy is contraindicated; d/c if pregnancy occurs. Perform a sensitive test (eg, β subunit test if available) capable of determining early pregnancy immediately prior to start of therapy; use a nonhormonal method of contraception during therapy. Exposure in utero may result in androgenic effects on the female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia reported. Thromboembolism, thrombotic and thrombophlebitic events (eg, sagittal sinus thrombosis and life-threatening/fatal strokes) reported. Peliosis hepatis and benign hepatic adenoma observed with long-term use; determine the lowest dose that will provide adequate protection. Consider periodic attempts to decrease or withdraw therapy if the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress, or other cause. Associated with benign intracranial HTN (pseudotumor cerebri); early signs and symptoms include papilledema, headache, N/V, and visual disturbances. D/C immediately if papilledema is present and refer the patient to a neurologist for further diagnosis and care.
Treatment of endometriosis amenable to hormonal management. To decrease symptoms of fibrocystic breast disease (eg, nodularity, pain, tenderness). Prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
Initial: 200-400mg in 2 divided doses
Titrate: Adjust depending on response
Moderate to Severe Disease/Infertility:
Initial: 800mg in 2 divided doses
Titrate: Gradually titrate downward to maintain amenorrhea
Continue uninterrupted for 3-6 months but may extend to 9 months if necessary; may reinstitute if symptoms recur after discontinuation
Fibrocystic Breast Disease
Decreases Symptoms (eg, Breast Pain/Tenderness):
Usual Range: 100-400mg/day given in 2 divided doses, depending on patient response
Usual Duration: 4-6 months of uninterrupted therapy
A nonhormonal method of contraception is recommended
Initial: 200mg bid or tid
Maint: After a favorable initial response is obtained, continuing dose should be determined by decreasing the dose by ≤50% at intervals of ≥1-3 months
If attacks occur, the daily dose may be increased by up to 200mg
Cap: 50mg, 100mg, 200mg
Undiagnosed abnormal genital bleeding, markedly impaired hepatic/renal/cardiac function, pregnancy, breastfeeding, porphyria, androgen-dependent tumor, active and history of thrombosis or thromboembolic disease.
Temporary alteration of lipoproteins (decreased HDL and increased LDL) reported; consider potential impact on risk of atherosclerosis and coronary artery disease. Exclude breast carcinoma before initiating therapy of fibrocystic breast disease; consider carcinoma and rule out if any nodule persists or enlarges during treatment. Monitor for androgenic effects. May cause some degree of fluid retention; conditions that might be influenced by this factor (eg, epilepsy, migraine, cardiac/renal dysfunction, polycythemia, HTN) require careful observation. Caution with diabetes mellitus (DM). Hepatic dysfunction reported; perform LFTs periodically. Exacerbation of manifestations of acute intermittent porphyria reported. Consider hematologic state monitoring. Closely monitor patients with hereditary angioedema during dose adjustment, particularly if patient has a history of airway involvement. Lab test interactions may occur.
Thromboembolism, thrombotic/thrombophlebitic events, peliosis hepatis, benign hepatic adenoma, benign intracranial HTN, weight gain, acne, seborrhea, menstrual disturbances, nervousness, emotional lability.
May prolong PT with warfarin. May increase carbamazepine levels. Caution with antidiabetic drugs; may cause insulin resistance. May increase cyclosporine and tacrolimus levels leading to increased risk of renal toxicity; may need to adjust dose. May increase calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism. May increase the risk of myopathy and rhabdomyolysis with statins (eg, simvastatin, atorvastatin, and lovastatin); use with caution.
PREGNANCY AND LACTATION
Category X, not for use in nursing.
MECHANISM OF ACTION
Androgen; ethisterone derived synthetic steroid. Endometriosis: alters normal and ectopic endometrial tissue to become inactive and atrophic. Fibrocystic breast disease: produces partial to complete disappearance of nodularity and complete relief of pain and tenderness. Hereditary angioedema: prevents episodic edema of abdominal viscera, extremities, face, and airway; increases levels of deficient C1 esterase inhibitor.
Absorption: Administration of variable doses resulted in different parameters. Metabolism: 2-hydroxymethyl danazol and ethisterone (metabolites). Elimination: Urine, feces; T1/2=9.7 hrs (healthy males), 23.7 hrs (endometriosis patients).
Assess for undiagnosed abnormal genital bleeding, hepatic/renal/cardiac dysfunction, porphyria, androgen-dependent tumor, history of or active thrombosis/thromboembolic disease, hypersensitivity to drug, breast carcinoma, history of airway condition, polycythemia, epilepsy, migraine, hypertension, DM, pregnancy/nursing status, and possible drug interactions.
Monitor for thromboembolism, thrombotic/thrombophlebitic events, peliosis hepatis and hepatic adenoma with long-term use, benign intracranial HTN, alteration of lipoproteins, breast nodules (persistence or enlargement), androgenic effects, fluid retention and other adverse reactions. Monitor LFTs periodically. Consider hematologic state monitoring.
Instruct to take as prescribed. Inform of the benefits and risks of treatment. Advise to use a nonhormonal method of contraception during therapy. Apprise of the potential risks to the fetus; instruct to d/c therapy if patient becomes pregnant. Inform patients with fibrocystic breast disease that treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy. Instruct to report any adverse reactions that may develop to physician.
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