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Indications - Danazol is indicated for the following treatment- Endometriosis Benign breast disease Menorrhagia Gynecomastia Preoperative thinning of the endometrium before hysteroscopic endometrial ablation.

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

Side Effects - Oedema, weight gain, sweating, acne, hirsutism, flushing, oily skin or hair, deepening of the voice, clitoral hypertrophy, amenorrhoea, hepatic dysfunction, CNS or GI disturbances, benign intracranial hypertension, reduction in breast size, visual disturbances, elevated LFT values.

Contraindications - Pregnancy and breast-feeding Impaired hepatic, renal, or cardiac function Porphyria Thromboembolic disease Androgen-dependent tumor Abnormal vaginal bleeding that has not been fully investigated. Hypersensitivity to danazol.

Others - Pregnancy & Lactation Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.