Danazol

Danazol capsules are recommended for the treatment of: 1. Endometriosis. To control pain, pelvic tenderness and other associated symptoms and to resolve or reduce the extent of endometriotic foci. Danazol capsules may be used as sole therapy, in preparation for or following surgery or in patients not responding to other treatments.

2. Dysfunctional uterine bleeding presenting as menorrhagia. To control excessive blood loss and to control associated dysmenorrhoea. 3. For the treatment of severe cyclical mastalgia with or without nodularity (fibrocystic disease) unresponsive to counselling or simple analgesics.

To reduce pain, tenderness and nodularity. 4. For the control of benign, multiple or recurrent breast cysts in conjunction with aspiration. 5. Severe symptomatic gynaecomastia, both idiopathic as well as drug induced, to reduce the size of the breast and to control associated pain and tenderness.

6. Pre-operative thinning of the endometrium prior to hysteroscopic endometrial ablation.

AND CLINICAL USE

Endometriosis:

Cyclomen (danazol) is indicated for the treatment of endometriosis associated symptoms and/or to reduce the extent of endometriotic foci. Cyclomen may be used either in conjunction with surgery or, as sole hormonal therapy, in patients not responding to other treatments.

Benign Fibrocystic Breast Disease:

Cyclomen (danazol) is indicated for the symptomatic relief of severe pain and tenderness associated with fibrocystic disease of the breast. Cyclomen should be used in those patients who do not obtain adequate relief through other therapeutic measures or in whom such measures are otherwise inadvisable.

Carcinoma of the breast should be excluded prior to commencing treatment. The treatment course should be limited to three to six months maximum. CONTRAINDICATIONS Cyclomen (danazol) is contraindicated in patients presenting with: 1) undiagnosed abnormal genital bleeding; 2) genital neoplasia; 3) markedly impaired hepatic, renal or cardiac function; 4) pregnancy (see WARNINGS) ; 5) breast feeding; 6) porphyria - Cyclomen can induce ALA synthetase activity and should not be used in patients with known or suspected acute intermittent porphyria; 7) androgen-dependent tumor; 8) active thrombosis or thromboembolic disease and history of such events.