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Danazol Generic Name & Formulations
Legal Class
Rx
General Description
Danazol 50mg, 100mg, 200mg; caps.
Pharmacological Class
Androgen.
How Supplied
Contact supplier.
Manufacturer
Danazol Indications
Indications
Endometriosis amenable to hormonal management.
Danazol Dosage and Administration
Adult
Start therapy during menstruation, continue uninterrupted for 3–6 months but may be extended to 9 months if necessary. Mild: initially 200–400mg/day in 2 divided doses; may adjust based on response. Moderate to severe, or infertile: initially 800mg/day in 2 divided doses; gradually titrate downward to maintain amenorrhea based on response.
Children
Not established.
Danazol Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function. Pregnancy. Nursing mothers. Porphyria. Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events.
Danazol Boxed Warnings
Boxed Warning
Teratogenic effects. Thromboembolism, thrombotic, and thrombophlebitic events. Peliosis hepatis and hepatic adenoma. Benign intracranial hypertension also known as pseudotumor cerebri.
Danazol Warnings/Precautions
Warnings/Precautions
See Contraindications. Pregnancy: exclude status prior to initiation; use sensitive tests (eg, beta subunit tests). Advise to use nonhormonal method of contraception during therapy. Risk of peliosis hepatis and benign hepatic adenoma with long-term use: determine the lowest effective dose. Consider reduction or discontinuation if treatment was initiated during exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause. Screen for papilledema in those with benign intracranial hypertension symptoms. Discontinue immediately if papilledema is present; refer to a neurologist for evaluation. Alteration of lipoproteins. Potential risk of atherosclerosis, coronary artery disease. Monitor closely for androgenic effects. Epilepsy, migraine, cardiac or renal dysfunction, polycythemia, hypertension; monitor for fluid retention. Diabetes mellitus. Obtain periodic liver function and hematology tests.
Danazol Pharmacokinetics
See Literature
Danazol Interactions
Interactions
May prolong prothrombin time with warfarin. May potentiate carbamazepine. May cause insulin resistance; caution with antidiabetic drugs. May potentiate cyclosporine, tacrolimus; monitor for renal toxicity and dose adjustments may be needed. May potentiate the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism. Increased risk of myopathy and rhabdomyolysis with statins (eg, simvastatin, atorvastatin, lovastatin); use caution. May interfere with laboratory tests of testosterone, androstenedione, and dehydroepiandrosterone. May reduce thyroid binding globulin and T4 with increased uptake of T3.
Danazol Adverse Reactions
Adverse Reactions
Weight gain, acne, seborrhea, mild hirsutism, edema, hair loss, voice change, menstrual disturbances, flushing, sweating, vaginal dryness, irritation/reduction in breast size, nervousness, emotional lability, reduction in spermatogenesis, hepatic dysfunction.
Danazol Clinical Trials
See Literature
Danazol Note
Notes
Formerly known under the brand name Danocrine.
Danazol Patient Counseling
See Literature
Danazol Generic Name & Formulations
Legal Class
Rx
General Description
Danazol 50mg, 100mg, 200mg; caps.
Pharmacological Class
Androgen.
How Supplied
Contact supplier.
Manufacturer
Danazol Indications
Indications
Prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal).
Danazol Dosage and Administration
Adult
Individualize based on response. Initially 200mg two to three times daily. If favorable initial response, continue by reducing dose by 50% or less at 1–3 month intervals or longer as needed. If an attack occurs, may increase daily dosage by up to 200mg. Monitor closely during dose adjustment (esp. in those with a history of airway involvement).
Children
Not established.
Danazol Contraindications
Contraindications
Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function. Pregnancy. Nursing mothers. Porphyria. Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events.
Danazol Boxed Warnings
Boxed Warning
Teratogenic effects. Thromboembolism, thrombotic, and thrombophlebitic events. Peliosis hepatis and hepatic adenoma. Benign intracranial hypertension also known as pseudotumor cerebri.
Danazol Warnings/Precautions
Warnings/Precautions
See Contraindications. Pregnancy: exclude status prior to initiation; use sensitive tests (eg, beta subunit tests). Advise to use nonhormonal method of contraception during therapy. Risk of peliosis hepatis and benign hepatic adenoma with long-term use: determine the lowest effective dose. Consider reduction or discontinuation if treatment was initiated during exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause. Screen for papilledema in those with benign intracranial hypertension symptoms. Discontinue immediately if papilledema is present; refer to a neurologist for evaluation. Alteration of lipoproteins. Potential risk of atherosclerosis, coronary artery disease. Monitor closely for androgenic effects. Epilepsy, migraine, cardiac or renal dysfunction, polycythemia, hypertension; monitor for fluid retention. Diabetes mellitus. Obtain periodic liver function and hematology tests.
Danazol Pharmacokinetics
See Literature
Danazol Interactions
Interactions
May prolong prothrombin time with warfarin. May potentiate carbamazepine. May cause insulin resistance; caution with antidiabetic drugs. May potentiate cyclosporine, tacrolimus; monitor for renal toxicity and dose adjustments may be needed. May potentiate the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism. Increased risk of myopathy and rhabdomyolysis with statins (eg, simvastatin, atorvastatin, lovastatin); use caution. May interfere with laboratory tests of testosterone, androstenedione, and dehydroepiandrosterone. May reduce thyroid binding globulin and T4 with increased uptake of T3.
Danazol Adverse Reactions
Adverse Reactions
Weight gain, acne, seborrhea, mild hirsutism, edema, hair loss, voice change, menstrual disturbances, flushing, sweating, vaginal dryness, irritation/reduction in breast size, nervousness, emotional lability, reduction in spermatogenesis, hepatic dysfunction.
Danazol Clinical Trials
See Literature
Danazol Note
Notes
Formerly known under the brand name Danocrine.
Danazol Patient Counseling
See Literature
