• Treatment of moderate endometriosis that is unresponsive to conventional therapy.
• Palliative therapy of fibrocystic breast disease.
• Prophylaxis of hereditary angioedema.

Contraindicated in:

• Hypersensitivity
• Male patients with breast or prostate cancer
• Hypercalcemia
• Severe hepatic, renal, or cardiac disease
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation.

Use Cautiously in:

• Previous history of liver disease
• History of porphyria
• Coronary artery disease
• Pedi: Safety and effectiveness not established in children.

CV: edema.

Derm: acne, hirsutism, oiliness.

EENT: deepening of voice.

Endo: ↓breast size (women), amenorrhea, anovulation, ↓ libido.

GI: hepatitis (cholestatic jaundice).

GU: amenorrhea, clitoral enlargement, testicular atrophy.

Metab: weight gain.

Neuro: emotional lability.

Drug-Drug:

• May potentiate warfarin, oral hypoglycemic agents, insulins, or corticosteroids.
• May ↑ cyclosporine or carbamazepine levels and risk of toxicity.
• May ↑ the requirement for insulin in patients with diabetes.
• ↑risk of myopathy or rhabdomyolysis with HMG Co-A reductase inhibitors.

(Generic available)

• Capsules: 50 mg; 100 mg; 200 mg;

Endometriosis

• PO (Adults): 400 mg twice daily (for milder cases may initiate therapy with 100–200 mg twice daily).

Fibrocystic Breast Disease

• PO (Adults): 50–200 mg twice daily.

Hereditary Angioedema

• PO (Adults): 200 mg 2–3 times daily. Attempt to ↓ dosage by 50% or less every 1–3 mo. If acute attack occurs, ↑ dose by up to 200 mg/day.

Danocrine

• Inhibits pituitary output of gonadotropins, resulting in suppression of ovarian function. Has weak androgenic-anabolic activity.

• Atrophy of ectopic endometrial tissue in endometriosis.
• Decreased pain and nodularity in fibrocystic breast disease.
• Correction of biochemical abnormalities in hereditary angioedema.

Therapeutic Classification: hormones

Pharmacologic Classification: androgens

Absorption: Absorbed from the GI tract.

Distribution: Unknown.

Metabolism/Excretion: Metabolized by the liver.

Half-life: 4.5 hr.

Cyclomen

(disease response)

• General Info: Instruct patient to take medication exactly as directed. Take missed doses as soon as remembered, if not almost time for next dose; do not double doses.
  • Advise patient to notify health care professional if masculinizing effects occur (abnormal growth of facial hair or other body hair, deepening of the voice).
  • Advise patient to use sunscreen and protective clothing to prevent photosensitivity reactions.
  • Rep: Advise patient to use a nonhormonal form of contraception and avoid breastfeeding during therapy. Inform patient that amenorrhea is expected with higher doses. Instruct patient to notify health care professional if regular menstruation does not occur within 60–90 days after discontinuation of therapy or if pregnancy is suspected.
  • Emphasize the importance of routine visits to health care professional to check progress during therapy.
• Fibrocystic Breast Disease: Teach patient the correct technique for monthly breast self-exam. Instruct patient to report increase in size of nodules to health care professional promptly.

DA-na-zole

NDC Code^*

• 0527- Lannett Company, Inc.
  • 0527-1368- Danazol
    • 0527-1368-01- 100 CAPSULE in 1 BOTTLE (0527-1368-01)

• 0527- Lannett Company, Inc.
  • 0527-1369- Danazol
    • 0527-1369-01- 100 CAPSULE in 1 BOTTLE (0527-1369-01)

• 0527- Lannett Company, Inc.
  • 0527-1369- Danazol
    • 0527-1369-06- 60 CAPSULE in 1 BOTTLE (0527-1369-06)

• 0527- Lannett Company, Inc.
  • 0527-1392- Danazol
    • 0527-1392-01- 100 CAPSULE in 1 BOTTLE (0527-1392-01)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0633- Danazol
    • 0555-0633-02- 100 CAPSULE in 1 BOTTLE (0555-0633-02)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0634- Danazol
    • 0555-0634-02- 100 CAPSULE in 1 BOTTLE (0555-0634-02)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0635- Danazol
    • 0555-0635-02- 100 CAPSULE in 1 BOTTLE (0555-0635-02)

• 0555- Teva Pharmaceuticals USA, Inc.
  • 0555-0635- Danazol
    • 0555-0635-09- 60 CAPSULE in 1 BOTTLE (0555-0635-09)

• 42291- AvKARE, Inc.
  • 42291-243- Danazol
    • 42291-243-01- 100 CAPSULE in 1 BOTTLE (42291-243-01)