Adult Dosing
Moderate to severe endometriosis
- Initial dose: 800 mg PO divided bid x 3-9 months; adjust dose based on patient response
Mild endometriosis
- Initial dose: 200-400 mg PO divided bid x 3-9 months, dose modified depending upon patient response
Fibrocystic breast disease
- Usual dose: 100-400 mg PO divided bid x 4-6 months, dose modifications based upon patient response
Notes:
- Therapy should begin during menstruation and appropriate tests should be performed to rule out pregnancy during therapy
- If symptoms recur after termination of therapy, treatment may be re-instituted
Hereditary angioedema
- Starting dose 200 mg PO bid or tid; after a favorable initial response, decrease dose by 50% or less at intervals of 1-3 months or longer
- Increase dose up to 200 mg/day PO; if an edematous attack occurs during treatment
Note:
- Monitor the patient's response closely during dose modifications, especially if the patient has a history of airway involvement
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Avoid use of danazol in pregnancy; discontinue therapy if the patient becomes pregnant while on treatment and apprise the patient about the potential risk to the fetus. In utero exposure to danazol may result in androgenic effects on the female fetus such as clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia [US Black Box Warning]
- Peliosis hepatis and benign hepatic adenoma have occurred during long-term use, and these may be silent until complicated by acute, potentially life-threatening intra-abdominal hemorrhage [US Black Box Warning]
- Temporary alteration of lipoproteins in the form of decreased HDL and increased LDL has been reported during therapy. Consider the potential impact on the risk of atherosclerosis and coronary artery disease in accordance with the potential benefit of the therapy to the patient
- Prior to therapy of fibrocystic breast disease with danazol, carcinoma of the breast should be ruled out. However, nodularity, pain, tenderness due to fibrocystic breast disease may prevent recognition of underlying carcinoma prior to therapy. Thus, if any nodule persists or enlarges during treatment, carcinoma should be considered and ruled out
- Closely monitor patients for signs of androgenic effects, some of which may not be reversible even after the drug is stopped
- Exacerbation of acute intermittent porphyria has been reported after administration of danazol
- Perform periodic liver function tests because hepatic dysfunction manifested by modest increases in serum transaminase levels may occur in patients treated with danazol
Cautions: Use cautiously in
- Migraine
- Epilepsy
- Congestive heart failure
- Renal dysfunction
Pregnancy Category:X
Breastfeeding: Contraindicated
Pricing data from www.DrugStore.com in U.S.A.
- Danazol 50 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $55.99
90 mg = $155.98 - Danazol 100 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $69.99
90 mg = $199.98 - Danazol 200 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $110.76
90 mg = $322.63
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.