Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).

Reduction in risk of surgery and acute urinary retention in patients with moderate to severe symptoms of BPH.

Contraindications

Children under 18 years
Females
Severe hepatic impairment

Precautions and Warnings

Mild hepatic impairment

Some products may contain soya or soya derivative
Absorbed by skin - avoid contact with leaking capsules
Evaluate for prostate cancer before and during treatment
Combination with alpha blocker: Increased incidence of cardiac failure
Establish new PSA baseline at 6 months and monitor PSA regularly thereafter
Investigate any sustained increase in PSA during treatment
Advise patient to report any breast changes e.g. lumps, pain or discharge
Causes a decrease in serum prostate specific antigen (PSA) by approx. 50%
Advise patient grapefruit products may increase plasma level
May reduce sperm count, function, motility or seminal fluid volume
Male: Use of condoms advised if partner pregnant or may become pregnant

Pregnancy and Lactation

Pregnancy

Not indicated for use in women.

Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a women carrying a male foetus, inhibit the development of the external genitalia of the foetus.

Small amounts of dutasteride have been found in the semen of men undergoing treatment. It is not known if a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with dutasteride, however the risk would be higher during the first 16 weeks of pregnancy.

Lactation

Not indicated for use in women.

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

Side Effects

Allergic reaction
Alopecia
Angioedema
Breast enlargement
Breast tenderness
Depressed mood
Ejaculation disorders
Hypertrichosis
Impotence
Oedema
Pruritus
Rash
Reduced libido
Urticaria

Presentation

Oral formulations of dutasteride.

Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia

Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).

Reduction in risk of surgery and acute urinary retention in patients with moderate to severe symptoms of BPH.

Dosage

Adults

Contraindications

Children under 18 years
Females
Severe hepatic impairment

Precautions and Warnings

Mild hepatic impairment

Some products may contain soya or soya derivative
Absorbed by skin - avoid contact with leaking capsules
Evaluate for prostate cancer before and during treatment
Combination with alpha blocker: Increased incidence of cardiac failure
Establish new PSA baseline at 6 months and monitor PSA regularly thereafter
Investigate any sustained increase in PSA during treatment
Advise patient to report any breast changes e.g. lumps, pain or discharge
Causes a decrease in serum prostate specific antigen (PSA) by approx. 50%
Advise patient grapefruit products may increase plasma level
May reduce sperm count, function, motility or seminal fluid volume
Male: Use of condoms advised if partner pregnant or may become pregnant

Pregnancy and Lactation

Pregnancy

Not indicated for use in women.

Dutasteride inhibits the conversion of testosterone to dihydrotestosterone and may, if administered to a women carrying a male foetus, inhibit the development of the external genitalia of the foetus.

Small amounts of dutasteride have been found in the semen of men undergoing treatment. It is not known if a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with dutasteride, however the risk would be higher during the first 16 weeks of pregnancy.

Lactation

Not indicated for use in women.

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

Counselling

Advise patient that dutasteride is absorbed through the skin and that women and children must avoid contact with leaking capsules. If contact is made with leaking capsules, the contact area should be washed immediately with soap and water.

Advise patients capsules should be swallowed whole and not chewed or opened as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.

Advise patient grapefruit products may increase plasma level of dutasteride.

Advise patients to report any changes in their breast tissue such as lumps or nipple discharge.

If the patient's partner is or may potentially be pregnant, it is recommended that the patient avoids exposure of his partner to semen by use of a condom.

Side Effects

Allergic reaction
Alopecia
Angioedema
Breast enlargement
Breast tenderness
Depressed mood
Ejaculation disorders
Hypertrichosis
Impotence
Oedema
Pruritus
Rash
Reduced libido
Urticaria

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: July 2019

Reference Sources

Summary of Product Characteristics: Avodart 0.5mg soft capsules. GlaxoSmithKline UK. Revised November 2017.
Summary of Product Characteristics: Dutasteride 0.5mg soft capsules. Accord Healthcare Ltd. Revised May 2019.
Summary of Product Characteristics: Avodart 0.5mg soft capsules. Dr Reddys Laboratories Ltd. Revised May 2016.
Summary of Product Characteristics: Zepron 0.5mg soft capsules. Ennogen Healthcare UK. Revised December 2017.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 July 2019