Trade Names:Danazol- Capsules 50 mg- Capsules 100 mg- Capsules 200 mgCyclomen (Canada)
Suppresses pituitary-ovarian axis by inhibiting output of pituitary gonadotropins; has weak, dose-related androgenic activity with no estrogenic or progestational activity.
Extent of availability and C max increase 3- to 4-fold, respectively, following food. T max delayed by 30 min after food.
Treatment of endometriosis; symptomatic treatment of fibrocystic breast disease; prevention of attacks of hereditary angioedema.
Treatment of precocious puberty, gynecomastia, and menorrhagia; treatment of idiopathic immune thrombocytopenia, lupus-associated thrombocytopenia, and autoimmune hemolytic anemia.
Pregnancy; lactation; undiagnosed abnormal genital bleeding; markedly impaired hepatic, renal, or cardiac function.
PO 800 mg/day in 2 divided doses.Fibrocystic Breast DiseaseAdults
PO 100 to 400 mg/day in 2 divided doses.Hereditary AngioedemaAdults
PO 200 mg 2 or 3 times daily.
Store drug in closed, light-resistant container at room temperature.
May increase anticoagulant effects.Carbamazepine
May increase carbamazepine concentration.Cyclosporine
May increase cyclosporine levels, thus increasing risk of nephrotoxicity.Insulin
Diabetic patients may need increased insulin doses.
May interfere with tests for determination of testosterone, androstenedione, and dehydroepiandrosterone levels.
Acne; mild hirsutism; oily skin or hair.
Jaundice; elevated LFT results; hepatic function impairment.
Edema; decreased breast size; deepening of voice; weight gain; flushing; sweating; vaginitis; nervousness; emotional lability; amenorrhea; anovulation; breakthrough bleeding.
Contraindicated in pregnancy. Negative pregnancy test must be obtained immediately prior to therapy. Nonhormonal method of contraception is recommended during therapy.Intracranial hypertension
Benign intracranial hypertension (pseudotumor cerebri) has been reported. Screen for early signs of intracranial hypertension (eg, headache, nausea, vomiting, visual disturbances).Peliosis hepatitis and benign hepatic adenoma
Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use.Thromboembolism and thrombotic events
Thromboembolism and thrombotic events have been reported, including life-threatening or fatal strokes.
Category X .
Drug contraindicated in breast-feeding women.
Safety and efficacy not established.
Hepatic function impairment may occur; observe patient; monitor LFTs periodically.
May not be reversible even when drug is discontinued.
Exclude before treatment of fibrocystic breast disease.
Carefully observe patients who cannot tolerate edema (eg, those with epilepsy, cardiac/renal dysfunction, migraine).
Limited. Similar drugs have been associated with serious toxicity (eg, cholestatic jaundice, peliosis hepatitis). Use lowest effective dose and consider decreasing dose or withdrawing therapy periodically.
Copyright © 2009 Wolters Kluwer Health.