Danazol: Effective Androgen Therapy for Hormonal Disorders
Danazol
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| Product dosage: 200mg | |||
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| Product dosage: 50mg | |||
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Synonyms | |||
Danazol is a synthetic androgen derivative with antigonadotropic properties, widely utilized in clinical endocrinology and gynecology for managing a spectrum of hormone-mediated conditions. It functions by suppressing pituitary-ovarian axis activity, leading to reduced secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This mechanism underpins its efficacy in treating endometriosis, hereditary angioedema, and certain benign breast disorders. Available in oral formulation, danazol offers a targeted therapeutic approach for patients requiring hormonal modulation under specialist supervision.
Features
- Synthetic steroid derived from ethisterone
- Exhibits androgenic, antiestrogenic, and antigonadotropic activity
- Oral administration with bioavailability ranging from 30-50%
- Plasma half-life approximately 15 hours
- Metabolized extensively in the liver
- Excreted primarily in urine and feces
Benefits
- Effectively reduces pelvic pain and lesion size in endometriosis
- Prevents attacks of hereditary angioedema by increasing C1 esterase inhibitor levels
- Alleviates symptoms of fibrocystic breast disease
- May improve hematologic parameters in certain cytopenias
- Provides symptomatic relief in gynecomastia
- Offers alternative therapy when conventional treatments are contraindicated
Common use
Danazol is primarily indicated for the treatment of endometriosis, providing significant relief from pain and reducing endometrial implant growth. It serves as first-line prophylaxis for hereditary angioedema, preventing potentially life-threatening swelling episodes. The medication finds application in managing fibrocystic breast disease when severe symptoms persist despite conservative measures. Off-label uses include treatment of precocious puberty, menorrhagia, and certain autoimmune disorders, though these applications require careful risk-benefit assessment.
Dosage and direction
Initial dosing for endometriosis typically ranges from 200-800 mg daily, divided into two to four doses, titrated to the lowest effective dose. For hereditary angioedema prophylaxis, starting doses of 200 mg two or three times daily are common, with maintenance doses adjusted based on clinical response. Administration should occur with food to minimize gastrointestinal discomfort. Treatment duration varies by indication, typically spanning 3-9 months for endometriosis, with periodic evaluation of therapeutic efficacy and adverse effects. Dosage adjustments are necessary in hepatic impairment.
Precautions
Liver function tests must be monitored regularly due to potential hepatotoxicity. Patients should undergo baseline and periodic lipid profile assessment given danazol’s atherogenic potential. Blood counts require monitoring for possible hematologic changes. Caution is warranted in patients with cardiac, renal, or hepatic impairment. Women of childbearing potential must use non-hormonal contraception during therapy. Patients should be advised about potential androgenic effects and the possibility of voice changes, which may be irreversible.
Contraindications
Danazol is contraindicated in patients with pregnancy or attempting conception due to teratogenic risks. It must not be used in individuals with undiagnosed abnormal genital bleeding, severe hepatic impairment, or porphyria. Contraindications include history of thromboembolic disorders and androgen-dependent neoplasms. Patients with known hypersensitivity to danazol or its components should avoid therapy. It is not recommended during breastfeeding or in patients with severe cardiac or renal disease.
Possible side effect
Common adverse effects include weight gain, acne, oily skin, and hirsutism resulting from androgenic activity. Patients may experience hot flashes, sweating, and menstrual irregularities. Gastrointestinal disturbances such as nausea and dyspepsia occur frequently. Less common effects include voice deepening, clitoral enlargement, and hepatic enzyme elevations. Rare but serious side effects include hepatitis, peliosis hepatis, and benign intracranial hypertension. Hematologic changes such as erythrocytosis and leukopenia may occur with prolonged therapy.
Drug interaction
Danazol may potentiate effects of warfarin, requiring careful INR monitoring. It can increase blood levels of carbamazepine, cyclosporine, and tacrolimus through CYP3A4 inhibition. Concurrent use with insulin or oral hypoglycemics may alter glycemic control. Danazol may reduce the efficacy of hormone replacement therapy and oral contraceptives. Concomitant administration with other hepatotoxic drugs increases risk of liver injury. Statin therapy may require adjustment due to danazol’s effect on lipid metabolism.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless approaching the time for the next scheduled dose. Patients should not double the dose to make up for missed administration. Consistent timing maintains stable drug levels, particularly important for angioedema prophylaxis. If multiple doses are missed, patients should contact their healthcare provider for guidance on resumption of therapy. Maintenance of a medication diary or use of pill organizers can improve adherence.
Overdose
Symptoms of overdose may include exaggerated androgenic effects, nausea, vomiting, and dizziness. Hepatic toxicity manifestations might include jaundice and abdominal pain. Management involves immediate gastric lavage if ingestion occurred within two hours, followed by supportive care. There is no specific antidote; treatment focuses on symptom management and monitoring of hepatic and hematologic parameters. Hemodialysis is not effective due to danazol’s high protein binding and extensive tissue distribution.
Storage
Store at controlled room temperature (20-25°C/68-77°F) in the original container, protected from light and moisture. Keep tightly closed and away from heat sources. Do not store in bathroom cabinets due to humidity fluctuations. Keep out of reach of children and pets. Do not use beyond the expiration date printed on packaging. Proper disposal of unused medication through take-back programs is recommended to prevent environmental contamination.
Disclaimer
This information serves educational purposes and does not replace professional medical advice. Treatment decisions must be made by qualified healthcare providers considering individual patient circumstances. Dosage and administration should follow prescribing information and local guidelines. Patients should report any adverse effects to their healthcare provider promptly. The manufacturer’s complete prescribing information contains comprehensive details about risks and benefits.
Reviews
Clinical studies demonstrate danazol’s efficacy in reducing endometriosis-associated pain scores by 60-80% within 3-6 months of therapy. For hereditary angioedema prophylaxis, clinical trials show attack frequency reduction of 70-90% at appropriate doses. Patient-reported outcomes indicate significant improvement in quality of life measures, though androgenic side effects remain a treatment-limiting factor for some individuals. Long-term follow-up data support its relative safety when used appropriately under specialist supervision with regular monitoring.