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danazol
generic
Black Box Warnings .
Pregnancy Contraindicated
contraindicated in pregnancy, use sensitive test to detect early pregnancy immediately before start tx; use non-hormonal contraception method during tx; D/C if pregnancy occurs, discuss potential fetal risk; in utero exposure may cause androgenic effects on female fetus incl. clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia
Thrombosis Risk
thromboembolism, thrombotic and thrombophlebitic events incl. sagittal sinus thrombosis and life-threatening or fatal strokes reported
Peliosis Hepatis/Benign Hepatic Adenoma
limited experience w/ long-term tx, peliosis hepatis and benign hepatic adenoma seen w/ long-term use; may be silent until complicated by acute potentially life-threatening intraabdominal hemorrhage; determine lowest dose for adequate protection; periodically consider decr. or withdraw tx if started during hereditary angioedema exacerbation due to trauma, stress, or other cause
Pseudotumor Cerebri
several cases benign intracranial HTN; early s/sx incl. papilledema, headache, nausea/vomiting, and visual disturbances; if these sx occur screen for papilledema, if present immediately D/C tx and see neurologist for further diagnosis and care
Adult Dosing .
Dosage forms: CAP: 50 mg, 100 mg, 200 mg
endometriosis, mild
- [100-200 mg PO bid x3-9mo]
- Start: during menstruation; Info: adjust dose based on response
endometriosis, mod-severe
- [400 mg PO bid x3-9mo]
- Start: during menstruation; Info: adjust dose based on response
hereditary angioedema
- [individualize dose PO bid-tid]
- Start: 200 mg PO bid-tid until response, then decr. dose 50% q1-3mo; Info: if attack occurs during tx, may incr. dose up to 200 mg/day
fibrocystic breast dz (off-label)
- [50-200 mg PO bid]
- Start: during menstruation; Info: adjust dose based on response
renal dosing
- [see below]
- marked impairment: contraindicated
- HD/PD: not defined
hepatic dosing
- [see below]
- marked impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.