Danazol

Drugs affecting Gonadotrophin · Androgen

Indications

Endometriosis, fibrocystic breast disease, hereditary angioedema.

Dosage

Hereditary Angioedema: Adults: Initial: 200 mg b.i.d- t.i.d. After favourable response, decrease up to 50% at intervals of >1-3 mth depending on frequency of attacks. Increase up to 200 mg if attack occurs. Endometriosis: Adults: Mild: 100-200 mg b.i.d. Moderate-Severe: 400 mg b.i.d. Start during menstruation & continue for 3-6 mth; may extend to 9 mth. Fibrocystic Breast Disease: Adults: 50-200 mg b.i.d. Start during menstruation. Children: Not applicable.

Adverse Effects

Nausea, dizziness, rashes, back ache, flushing, muscle spasm androgenic effects, weight gain, fluid retention, headache, emotional lability, cholestatic jaundice, benign intracranial hypertension, vertigo, migraine, fatigue, menstrual disturbances, sexual dysfunction, cardiovascular reactions, haematological and thyroid effects, hepatic and pancreatic reactions, thrombotic events, aggravation of epilepsy, carpal tunnel syndrome, pleuritic pain, interstitial pneumonitis, skin reactions, insulin resistance, changes in glucose tolerance, visual disturbances.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Porphyria, thromboembolic disease, undiagnosed genital bleeding androgen dependent tumours. Severe hepatic, cardiac or renal dysfunction. Precautions: Severe hepatic, cardiac and renal dysfunction, epilepsy, migraine. Diabetes. Susceptibility to weight gain, hypertension or other cardiovascular disease, lipoprotein disorders, states exacerbated by fluid retention, polycythaemia, known or suspected malignancy, androgenic reactions to previous gonadal steroid therapy. Monitor patient, hepatic function, haematology; withdraw if androgenic reactions, symptoms of raised intracranial pressure, liver dysfunction, thrombosis or significant adverse events occur.

Interactions

Oral contraceptives, anticoagulants, carbamazepine, cyclosporin, anticonvulsants, cyclosporin, tacrolimus, hypoglycaemics, antihypertensives, simvastatin, other statins, alfacalcidol, alcohol.

Advice to Patient

Take consistently either with or without meals. Contact prescriber if there is deepening of voice; unusual growth of body hair; changes in menstrual pattern; constant penile erections; swelling of ankles, feet or hands; difficulty in breathing; sudden weight gain; change in colour of urine or stool; unusual bruising or bleeding; yellowing of eyes or skin. Check serum glucose level regularly if you have diabetes and inform prescriber about changes. For self-breast examination techniques, contact prescriber.

Pharmacokinetics

Absorption: Absorbed from the GI tract. Metabolism: Hepatic. Half-life elimination: Single dose: 3-6 hrs. Repeated dosing: About 26 hrs. Time to peak, plasma: 2-3 hrs. Excretion: Urine. Faeces.

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.