Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia
Reduce the need for surgery in benign prostatic hyperplasia
Reduced risk of acute urinary retention in benign prostatic hyperplasia

Contraindications

Children under 18 years
Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
High residual volume of urine
Lactose intolerance

Contains lactose
Staff: Not to be handled by pregnant staff
Evaluate for prostate cancer before and during treatment
Investigate any sustained increase in PSA during treatment
Monitor patients with large residual urine volume for obstructive uropathy
Monitor patients with severely reduced urine flow for obstructive uropathy
Advise patient to report any breast changes e.g. lumps, pain or discharge
Advise patient to report any new or worsening depression/suicidal ideation
Causes a decrease in serum prostate specific antigen (PSA) by approx. 50%
Male: Use of condoms advised if partner pregnant or may become pregnant
Women should not handle crushed/broken tablets due to risk of absorption

Pregnancy and Lactation

Pregnancy

Not indicated for use in women.

Because of the ability of type II 5-alpha-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman. Pregnant women and women of child-bearing potential should avoid handling crushed or broken tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus.

Use of condoms is recommended if sexual partner is pregnant or is likely to become pregnant as finasteride is excreted in semen. Small amounts of finasteride have been recovered from the semen in subjects receiving finasteride 5 mg/day. It is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride.

A small amount of finasteride, less than 0.001% of a 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking finasteride. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus.

Post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for 8 live male births, and one retrospectively reported case concerned an infant with simple hypospadias which is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.

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 to 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

Not indicated for use in women.

It is not known whether finasteride is excreted in human milk.

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

Breast enlargement
Breast nodules (benign)
Breast secretion
Breast tenderness
Decrease in prostate specific antigen (PSA)
Decreased ejaculate volume
Depression
Depressive symptoms
Ejaculation disorders
Erectile dysfunction
Hypersensitivity reactions
Impotence
Increased risk of breast cancer
Increases in hepatic enzymes
Palpitations
Pruritus
Rash
Reduced libido
Suicidal tendencies
Swelling of lips and face
Testicular pain
Urticaria

Presentation

Tablets containing finasteride

Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia
Reduce the need for surgery in benign prostatic hyperplasia
Reduced risk of acute urinary retention in benign prostatic hyperplasia

Dosage

Although early improvement in symptoms may be seen, treatment for at least 6 months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued long term.

Adults

Elderly

Additional Dosage Information

Contraindications

Children under 18 years
Galactosaemia

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Hepatic impairment
High residual volume of urine
Lactose intolerance

Contains lactose
Staff: Not to be handled by pregnant staff
Evaluate for prostate cancer before and during treatment
Investigate any sustained increase in PSA during treatment
Monitor patients with large residual urine volume for obstructive uropathy
Monitor patients with severely reduced urine flow for obstructive uropathy
Advise patient to report any breast changes e.g. lumps, pain or discharge
Advise patient to report any new or worsening depression/suicidal ideation
Causes a decrease in serum prostate specific antigen (PSA) by approx. 50%
Male: Use of condoms advised if partner pregnant or may become pregnant
Women should not handle crushed/broken tablets due to risk of absorption

Pregnancy and Lactation

Pregnancy

Not indicated for use in women.

Because of the ability of type II 5-alpha-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman. Pregnant women and women of child-bearing potential should avoid handling crushed or broken tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus.

Use of condoms is recommended if sexual partner is pregnant or is likely to become pregnant as finasteride is excreted in semen. Small amounts of finasteride have been recovered from the semen in subjects receiving finasteride 5 mg/day. It is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride.

A small amount of finasteride, less than 0.001% of a 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking finasteride. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus.

Post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for 8 live male births, and one retrospectively reported case concerned an infant with simple hypospadias which is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.

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 to 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

Not indicated for use in women.

It is not known whether finasteride is excreted in human milk.

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

Counselling

Advise patient to use condoms if sexual partner is pregnant or likely to become pregnant.

Advise patient not to let women who are, or may be pregnant handle this medication due to possible adverse effects on the foetus.

Advise patient to report any breast changes e.g. lumps, pain or discharge.

Side Effects

Breast enlargement
Breast nodules (benign)
Breast secretion
Breast tenderness
Decrease in prostate specific antigen (PSA)
Decreased ejaculate volume
Depression
Depressive symptoms
Ejaculation disorders
Erectile dysfunction
Hypersensitivity reactions
Impotence
Increased risk of breast cancer
Increases in hepatic enzymes
Palpitations
Pruritus
Rash
Reduced libido
Suicidal tendencies
Swelling of lips and face
Testicular pain
Urticaria

Effects on Laboratory Tests

Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels generally decrease in patients treated with finasteride. In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilise to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with finasteride for 6 months or more, PSA values should be doubled for comparison to normal ranges in untreated men.

Percent free PSA (free to total PSA ratio) is not significantly decreased by finasteride and remains constant even under the influence of finasteride. When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment is necessary.

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 ).

Further Information

Last Full Review Date: January 2016

Reference Sources

Summary of Product Characteristics: Proscar 5mg film-coated Tablets. Merck Sharp and Dohme Ltd. Revised August 2017.

Summary of Product Characteristics: Finasteride 5 mg tablets. Actavis UK Ltd. Revised June 2015.

Summary of Product Characteristics: Finasteride 5mg tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised June 2012.

Summary of Product Characteristics: Finasteride 5 mg film-coated tablets. Teva UK Ltd. Revised November 2015.

Summary of Product Characteristics: Finasteride 5 mg film-coated tablets. Wockhardt UK Ltd. Revised July 2014.

Summary of Product Characteristics: Propecia 1mg tablets. Merck Sharp and Dohme Limited. Revised July 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 September 2017