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Dosage/Direction for Use
Oral Endometriosis Adult: 200-800 mg daily in 2-4 divided doses, adjust according to response. Duration of treatment: 3-6 mth, up to 9 mth if necessary. Renal impairment: Severe: Contraindicated. Hepatic impairment: Severe: Contraindicated. Oral Benign breast disorders Adult: Initially, 100-400 mg daily in 2 divided doses, adjust according to response. Duration of therapy: 3-6 mth. Renal impairment: Severe: Contraindicated. Hepatic impairment: Severe: Contraindicated. Oral Hereditary angioedema Adult: Initially, 200 mg bid or tid. After an initial response is obtained, reduced by ≤50% at intervals of 1-3 mth or longer depending on the frequency of attack prior to initiation; if an attack occurs during treatment, may increase by up to 200 mg daily. Renal impairment: Severe: Contraindicated. Hepatic impairment: Severe: Contraindicated. |
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Administration
May be taken with or without food. Take consistently either always w/ or always w/o meals.
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Contraindications
Undiagnosed abnormal genital bleeding, androgen-dependent tumour, thromboembolic disease or history of thrombosis, severe cardiac impairment. Severe hepatic and renal impairment. Pregnancy and lactation.
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Special Precautions
Patient w/ epilepsy, migraine, DM, polycythaemia, HTN and other CV disease, porphyria, lipoprotein disorder. Hepatic or renal impairment. Monitoring Parameters Perform LFT and renal function test periodically. Monitor haematologic parameters, lipid panel, signs and symptoms of intracranial HTN, androgenic changes, and/or fluid retention.
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Adverse Reactions
Significant: Androgenic effects (e.g. acne, seborrhoea, wt gain, hair loss, voice change, clitoral hyperthrophy), peliosis hepatis, benign hepatic adenoma, cholestatic jaundice, benign intracranial HTN.
Nervous: Nervousness, emotional lability, headache.
CV: Palpitations, tachycardia.
Resp: Interstitial pneumonitis.
Genitourinary: Vaginal dryness and irritation; abnormal semen volume, sperm count, viscosity and motility.
Endocrine: Menstrual disturbances.
Dermatologic: Rash, Steven-Johnsons syndrome, erythema multiforme.
Potentially Fatal: Thromboembolism, thrombotic and thrombophlebitic events, including sagittal sinus thrombosis and stroke. |
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Drug Interactions
May prolong prothrombin time when used w/ warfarin. May increase serum concentrations of carbamazepine, ciclosporin, tacrolimus. Increased risk of myopathy and rhabdomyolysis when concurrently administered w/ statins (e.g. simvastatin, atorvastatin, lovastatin). May increase calcaemic response to synthetic vit D analogs. May cause insulin resistance.
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Food Interaction
Food, particularly high-fat meal, increases plasma concentration and extent of availability.
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Lab Interference
May interfere w/ determination of testosterone, androstenedione, dehydroepiandrosterone or plasma proteins.
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Action
Danazol is an antigonadotropic agent which suppresses the pituitary-ovarian axis by inhibiting the pituitary output of FSH and LH, resulting in regression and atrophy of normal and ectopic endometrial tissue. It decreases growth rate of abnormal breast tissues, and also reduces attacks in hereditary angioedema by increasing C4 levels of the complement system.
Onset: Benign breast disorder: 1 mth (pain relief); 4-6 mth (nodule elimination). Absorption: Absorbed from the GI tract. Increased absorption w/ food. Time to peak plasma concentration: 4 hr. Metabolism: Extensively metabolised in the liver to 2-hydroxymethyl danazol and ethisterone. Excretion: Via urine and faeces. Elimination half-life: Approx 10 hr. |
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Storage
Oral: Store between 20-25°C. Protect from light.
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CIMS Class
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ATC Classification
G03XA01 - danazol ; Belongs to the class of antigonadotropins and similar agents.
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