Pharm

Danazol

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Danazol

  • See Also
  1. Endometriosis
  • Indications
  1. FDA Approved
    1. Endometriosis
    2. Fibrocystic Breast Disease
  2. Off-Label
    1. Menorrhagia
  • Contraindications
  1. Hepatic Impairment
  2. Renal Impairment
  3. Cardiac dysfunction
  4. Pregnancy
  • Mechanism
  1. Synthetic androgen derived from ethinyl Testosterone
  2. Inhibits gonadotropin (LH and FSH) secretion, resulting in decreased Estrogen secretion
  3. Danazol binds sex Hormone receptors in sensitive tissues
    1. Antiestrogenic and decreases Menstrual Bleeding
    2. Aanabolic and weakly androgenic (may affect voice)
  • Medications
  1. Danazol capsules: 50 mg, 100 mg, 200 mg
  • Dosing
  1. Endometriosis
    1. Start: 400 mg orally twice daily
    2. Titrate dose DOWN to lowest effective dose with goal Amenorrhea for 3-6 months (up to 9 months)
  2. Fibrocystic Breast Disease (or cyclical Mastalgia - off label use)
    1. Danazol 100 to 200 mg orally twice daily for up to 4 to 6 months
  • Adverse Effects
  1. Benign Intracranial Hypertension (Pseudotumor Cerebri)
  2. Peliosis hepatis
  3. Benign Hepatic Adenoma
  4. Androgenic Effects
    1. Acne Vulgaris
    2. Flushes
    3. Sweats
    4. Edema
    5. Libido changes
  • Safety
  1. Contraindicated in pregnancy (Pregnancy Category X)
    1. Associated with congenital abnormalities
    2. Use reliable non-Hormonal Contraception while taking Danazol (black box warning)
  2. Avoid in Lactation
  • Efficacy
  1. Same rate of pregnancy as with Provera or Surgery
  • Drug Interactions
  1. Insulin
    1. May increase Insulin requirements for adequate Glucose control
  2. Warfarin
    1. Increased INR with concurrent Danazol
  3. Danazol increases other drug levels
    1. Cyclosporine
    2. Tacrolimus
  4. Statins
    1. Increased risk of Statin-Induced Myopathy and Rhabdomyolysis
  • Resources
  1. Danazol (DailyMed)
    1. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e19acee5-ff33-45a5-bbbf-801756bc59b4