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danazol

G03XA01

Forms & Strengths

Capsules: 50 mg
Capsules: 100 mg
Capsules: 200 mg

Adult Dosing

Endometriosis: 400 mg to 800 mg daily in 2 divided doses for 3 to 9 months
Fibrocystic breast disease: 50 mg to 400 mg daily in 2 divided doses
Hereditary angioedema: Initial 200 mg every 8 hours, taper by 50% or more at 1-3 month intervals to maintenance dose

Pediatric Dosing

Safety and efficacy in pediatric patients have not been established
Hereditary angioedema (adolescents): Lowest effective dose, individualized based on clinical response

Indications

Treatment of endometriosis amenable to hormonal management
Prevention of attacks of hereditary angioedema in males and females
Treatment of severe fibrocystic breast disease not responding to other therapies

Mechanism of Action

Synthetic steroid derived from ethisterone with androgenic, anti-estrogenic, and anti-gonadotropic properties
Inhibits pituitary-ovarian axis by suppressing the surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
Increases plasma levels of C1 esterase inhibitor (C1INH) to treat hereditary angioedema

Contraindications

Undiagnosed abnormal genital bleeding
Markedly impaired hepatic, renal, or cardiac function
Pregnancy and breastfeeding
Porphyria
Active thrombosis or thromboembolic disease

Adverse Reactions

Weight gain, edema, acne, oily skin, seborrhea
Hirsutism, voice deepening, clitoral hypertrophy (androgenic effects)
Flushes, sweating, vaginal dryness, decreased breast size (hypoestrogenic effects)
Elevated hepatic transaminases, cholestatic jaundice
Benign intracranial hypertension (pseudotumor cerebri)

Drug Interactions

May increase plasma levels and risk of toxicity of carbamazepine and cyclosporine
Can potentiate the anticoagulant effect of warfarin, increasing bleeding risk
May decrease insulin requirements in diabetic patients
Concomitant use with statins increases the risk of myopathy and rhabdomyolysis

Curated Content: Needs Vetting Before Put to Clinical Use