Danazol

Indications

Danazol is used for: Endometriosis, Benign breast disorders, Gynaecomastia, Hereditary angioedema, Menorrhagia.

Adult Dose

Oral Endometriosis Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 mth or if necessary, up to 9 mth. Benign breast disorders Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 mth. Gynaecomastia Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 mth if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 mth. Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 mth if no response occurs. Treatment usually up to 6 months. Hereditary angioedema Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response. Preoperative thinning of the endometrium Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 wk. Menorrhagia Adult: 200 mg once daily. Review treatment 3 mth later.

Child Dose

Renal Dose

Administration

May be taken with or without food. Take consistently either always w/ or always w/o meals.

Contra Indications

Hypersensitivity, pregnancy, lactation, porphyria, thromboembolic disorders; undiagnosed genital bleeding, markedly impaired renal, cardiac or hepatic dysfunction.

Precautions

Danazol may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, polycythemia and hypertension require careful observation. Use with caution in patients with diabetes mellitus. Since hepatic dysfunction manifested by modest increases in serum transaminases levels has been reported in patients treated with Danazol, periodic liver function tests should be performed Administration of danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria. Lactation: enters breast milk/contraindicated

Pregnancy-Lactation

Pregnancy Category: X Lactation: enters breast milk/contraindicated

Interactions

Increased serum levels of ciclosporin, warfarin, carbamazepine and tacrolimus. Potentially Fatal: Increased incidence of insulin resistance in diabetic patients.

Adverse Effects

Side effects of Danazol : Frequency Not Defined Intracranial hypertension, Increased blood pressure, Thromboembolism, Anxiety, Depression, Dizziness, Urticaria Androgenic Effects (common) Mild hirsutism, Decreased breast size, Voice changes, Sore throat, acne, Increased oiliness of skin or hair, Hair loss, Menstrual irregularities (common), Gastroenteritis, Nausea, Vomiting, Elevated LFTs, Joint pain, Muscle spasm Potentially Fatal: Thromboembolic events and fatal strokes have been reported.

Mechanism of Action

Danazol suppresses the pituitary-ovarian axis by reducing the release of follicle-stimulating hormone and luteinizing hormone. This causes the regression and atrophy of endometrial tissue, decreases growth rate of abnormal breast tissue and reduces attacks in hereditary angioedema.