Drugs List

Therapeutic Indications

Uses

Prostate cancer

Metastatic post-menopausal carcinoma of the breast

Administration

For oral administration.

Contraindications

Moderate hypertension
Cerebrovascular disorder
History of thromboembolic disorder
Severe / active hepatic disorder
Hyperlipoproteinaemia
Cardiovascular disorder
Pulmonary hypertension
Sickle cell disease
Untreated polycythaemia

Children under 18 years of age

Galactosaemia

Additional contraindications for use in women
Premenopausal women (including premenopausal women with breast cancer)
Oestrogen-dependent neoplasms - especially of the genital tract
Endometrial hyperplasia
Uterine fibromyomata
History of herpes gestationis
Undiagnosed gynaecological bleeding
Pregnancy (see Pregnancy section)
Breastfeeding ( see Lactation section )

Precautions and Warnings

Diethylstilbestrol has carcinogenic potential and should not be used in children and young adults.

Use with caution in the following conditions:
Cardiac failure
Hypertension
Diabetes mellitus
Epileptic disorder
Migraine
Depression
Cholelithiasis
Mild to moderate hepatic impairment
Jaundice
History of jaundice - from any cause e.g. after oral contraceptives/following pregnancy
Renal impairment

In diabetes mellitus glucose tolerance may be lowered and the need for insulin or other anti-diabetic drugs may be increased.

Monitor blood pressure at regular intervals. Discontinue if hypertension develops.

The high oestrogenic activity associated with diethylstilbestrol treatment increases the risk of deep vein thrombosis.
Discontinue if signs or symptoms of thrombosis occur.
Discontinue before planned surgery.

Prolonged use may increase the risk of endometrial carcinoma.

May interfere with thyroid function tests as the level of thyroid binding globulin is increased leading to increased circulating total thyroid hormone.

Contact lens wearers may experience corneal irritation or discomfort.

This medication contains lactose and therefore patients with glucose-galactose malabsorption syndrome or those who are lactose intolerant should not take this drug.

The tablet coating contains sunset yellow (E110) - may cause allergic reaction.

Pregnancy and Lactation

Pregnancy

Contraindicated.

High doses are associated with vaginal carcinoma, urogenital abnormalities and reduced fertility in female offspring.
In the male offspring there is an increased risk of hypospadias.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Contraindicated.

There are no reports of its use during lactation, but it would be expected to affect the composition of milk. Given its carcinogenic potential, it use during breastfeeding is contraindicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Nausea
Vomiting
Headache
Exacerbation of migraine
Mood changes e.g. depression, elation
Fluid retention
Sodium retention
Oedema
Weight gain
Hypertension
Venous thrombosis
Arterial thrombosis
Thromboembolism
Cerebral thrombosis
Coronary thrombosis
Cholelithiasis
Cholestatic jaundice
Decreased glucose tolerance
Breast discomfort
Breast enlargement
Breast secretion
Breast pain
Chloasma
Rash
Erythema nodosum
Corneal discomfort in contact lens wearers

In males
Testicular atrophy
Impotence
Gynaecomastia
Feminisation in men

In females
Vaginal bleeding on withdrawal
Increased size of uterine fibromyomata
Endometriosis (aggravation of)
Endometriosis
Increased risk of endometrial carcinoma
Increased cervical secretion

Hypercalcaemia and bone pain in women treated for breast cancer.

Drugs List

Therapeutic Indications

Uses

Prostate cancer

Metastatic post-menopausal carcinoma of the breast

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For oral administration.

Contraindications

Moderate hypertension
Cerebrovascular disorder
History of thromboembolic disorder
Severe / active hepatic disorder
Hyperlipoproteinaemia
Cardiovascular disorder
Pulmonary hypertension
Sickle cell disease
Untreated polycythaemia

Children under 18 years of age

Galactosaemia

Additional contraindications for use in women
Premenopausal women (including premenopausal women with breast cancer)
Oestrogen-dependent neoplasms - especially of the genital tract
Endometrial hyperplasia
Uterine fibromyomata
History of herpes gestationis
Undiagnosed gynaecological bleeding
Pregnancy (see Pregnancy section)
Breastfeeding ( see Lactation section )

Precautions and Warnings

Diethylstilbestrol has carcinogenic potential and should not be used in children and young adults.

Use with caution in the following conditions:
Cardiac failure
Hypertension
Diabetes mellitus
Epileptic disorder
Migraine
Depression
Cholelithiasis
Mild to moderate hepatic impairment
Jaundice
History of jaundice - from any cause e.g. after oral contraceptives/following pregnancy
Renal impairment

In diabetes mellitus glucose tolerance may be lowered and the need for insulin or other anti-diabetic drugs may be increased.

Monitor blood pressure at regular intervals. Discontinue if hypertension develops.

The high oestrogenic activity associated with diethylstilbestrol treatment increases the risk of deep vein thrombosis.
Discontinue if signs or symptoms of thrombosis occur.
Discontinue before planned surgery.

Prolonged use may increase the risk of endometrial carcinoma.

May interfere with thyroid function tests as the level of thyroid binding globulin is increased leading to increased circulating total thyroid hormone.

Contact lens wearers may experience corneal irritation or discomfort.

This medication contains lactose and therefore patients with glucose-galactose malabsorption syndrome or those who are lactose intolerant should not take this drug.

The tablet coating contains sunset yellow (E110) - may cause allergic reaction.

Pregnancy and Lactation

Pregnancy

Contraindicated.

High doses are associated with vaginal carcinoma, urogenital abnormalities and reduced fertility in female offspring.
In the male offspring there is an increased risk of hypospadias.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Contraindicated.

There are no reports of its use during lactation, but it would be expected to affect the composition of milk. Given its carcinogenic potential, it use during breastfeeding is contraindicated.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Nausea
Vomiting
Headache
Exacerbation of migraine
Mood changes e.g. depression, elation
Fluid retention
Sodium retention
Oedema
Weight gain
Hypertension
Venous thrombosis
Arterial thrombosis
Thromboembolism
Cerebral thrombosis
Coronary thrombosis
Cholelithiasis
Cholestatic jaundice
Decreased glucose tolerance
Breast discomfort
Breast enlargement
Breast secretion
Breast pain
Chloasma
Rash
Erythema nodosum
Corneal discomfort in contact lens wearers

In males
Testicular atrophy
Impotence
Gynaecomastia
Feminisation in men

In females
Vaginal bleeding on withdrawal
Increased size of uterine fibromyomata
Endometriosis (aggravation of)
Endometriosis
Increased risk of endometrial carcinoma
Increased cervical secretion

Hypercalcaemia and bone pain in women treated for breast cancer.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Reference Sources

British National Formulary, 60th Edition (2010) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 36th edition (2009) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Diethylstilbestrol 5mg Tablets. Teva UK Ltd. Revised November 2006.