DIETHYLSTILBESTROL

Posology Adults:

Management of prostatic carcinoma: 1 - 3 mg daily. Management of post-menopausal breast carcinoma: 10 - 20 mg daily.

Children:

Diethylstilbestrol should not be used in children.

Elderly:

The recommended adult dose is appropriate. Method of administration For oral administration

As high doses of diethylstilbestrol in early pregnancy have caused vaginal carcinoma in female offspring 16-20 years later, it should not be used in pre-menopausal women. As with other oestrogens the following hormonal disturbances may occur, fluid retention, headache, nausea and vomiting, weight gain, hypertension, breast discomfort, chloasma, skin rashes, erythema nodosum, cholelithiasis and cholestatic jaundice.

Venous and arterial thrombosis, thromboembolism and possibly cerebral and coronary thrombosis are also risks. In women, diethylstilbestrol may cause an increase in the size of uterine fibromyomata, endometrial proliferation and/or an aggravation or recurrence of endometriosis and an excessive production of cervical mucous.

The risk of endometrial neoplasia is increased significantly. In both sexes the use of diethylstilbestrol may cause tenderness, pain, enlargement and secretion of milk-like fluid from the breast. It also may aggravate corneal discomfort in patients with contact lenses and be associated with fluctuating moods (both elation and depression) and headaches including an increase in incidence of migraine.

The general metabolic effects of diethylstilbestrol include sodium and water retention, reduced glucose tolerance and changes in body weight (usually increases). g. gynaecomastia and testicular atrophy, and impotence. Other effects may be withdrawal bleeding in women and an increased incidence of cholelithiasis.

In the event of prolonged usage there is an increased risk of endometrial carcinoma. Hypercalcaemia and bone pain may occur in women treated for breast cancer. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Diethylstilbestrol should not be used in children or young adults because it has carcinogenic potential. g. jaundice of pregnancy or following the use of oral contraceptives. During treatment with diethylstilbestrol blood pressure should be monitored at regular intervals and if hypertension develops, treatment should be stopped.

In addition, if surgery is contemplated or signs or symptoms of thrombosis develop treatment should be discontinued. This is because of the significant increase in risk of deep vein thrombosis in the presence of high oestrogen activity.

In patients who suffer from diabetes, glucose tolerance may be lowered, and the need for insulin or other anti-diabetic drugs may be increased. In thyroid disease or investigations of thyroid function, thyroid hormone binding globulin may be increased leading to increased circulating total thyroid hormone, which may lead to difficulty in interpreting thyroid function tests.

Excipients Patient with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Diethylstilbestrol is contra-indicated in those who are pregnant (it is not suitable for pre-menopausal women); and children. It is also contra-indicated in the following conditions; oestrogen-dependent neoplasms especially of the genital tract; pre- menopausal carcinoma of the breast; endometrial hyperplasia or uterine fibromyomata (fibroids).

Diethylstilbestrol should not be given where there is undiagnosed vaginal bleeding; a history of herpes gestationis; porphyria; moderate to severe hypertension; severe or active liver disease; hyperlipoproteinaemia; any cardiovascular or cerebrovascular disorder or a history of thrombo-embolism or conditions predisposing to it such as sickle cell anaemia, untreated polycythaemia and pulmonary hypertension.