Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia

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

Risk reduction of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.

Contraindications

Children under 18 years
Females
Micturition syncope
History of postural hypotension
Peri-operative period in ocular surgery
Severe hepatic impairment

Precautions and Warnings

Cataract
Glaucoma
Mild hepatic impairment
Renal impairment - creatinine clearance below 10ml/minute

Advise hypotension/syncope may affect ability to drive/operate machinery
Contains propylene glycol: may cause irritation
Contains soya or soya derivative
Capsule contents may cause irritation of the oropharyngeal mucosa
Absorbed by skin - avoid contact with leaking capsules
Establish new PSA baseline at 6 months and monitor PSA regularly thereafter
Investigate any sustained increase in PSA during treatment
Regular examination of prostate advised to exclude prostatic cancer
Advise patient to report any breast changes e.g. lumps, pain or discharge
Advise patient to sit or lie down at first signs of orthostatic hypotension
Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
Intraoperative Floppy Iris Syndrome has been reported in glaucoma surgery
Discontinue 1 to 2 weeks prior to cataract surgery
Discontinue if angioedema occurs
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

Dutasteride causes a decrease (of approximately 50%) in serum prostate-specific antigen (PSA) levels after 6 months of treatment. Increase from the lowest PSA level whilst on dutasteride with tamsulosin may indicate presence of prostate cancer or non-compliance to therapy, which should be evaluated. Previous PSA values should be sought for comparison when interpreting the PSA value for a patient.

During the pre-operative assessment prior to cataract surgery, surgeons must ascertain whether the patients have ever received tamsulosin. If they have, appropriate measures should be in place to manage any occurrence of Intraoperative Floppy Iris Syndrome (IFIS) during the procedure.

Breast cancer has been reported in men taking dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of dutasteride.

Incidence of cardiac failure was higher among subjects taking the combinations of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination.

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, inhibits the development of the external genitalia of the foetus.

Small amounts of dutasteride have been found in the semen of men undergoing treatment. Animal studies have shown that it is unlikely to have any adverse effect on a male foetus if the mother is exposed to the semen of a man undergoing treatment with dutasteride (the greatest risk is within the first 16 weeks of pregnancy). However, it is recommended that a condom is used in order to avoid exposure to pregnant or potentially pregnant women.

Animal studies showed no evidence of foetal harm after administration of tamsulosin.

Lactation

Not indicated for use in women.

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

Side Effects

Abnormal ejaculation
Allergic reaction
Alopecia
Angioedema
Asthenia
Breast enlargement
Breast tenderness
Cardiac failure
Constipation
Diarrhoea
Dizziness
Ejaculation disorders
Headache
Hypertrichosis
Impotence
Increased risk of breast cancer
Intraoperative floppy iris syndrome
Nausea
Oedema
Palpitations
Postural hypotension
Priapism
Pruritus
Rash
Reduced libido
Reduction in sperm count and volume
Rhinitis
Stevens-Johnson syndrome
Syncope
Urticaria
Vomiting

Presentation

Oral formulation containing dutasteride and tamsulosin hydrochloride.

Drugs List

Therapeutic Indications

Uses

Benign prostatic hyperplasia

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

Risk reduction of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.

Dosage

Adults

Contraindications

Children under 18 years
Females
Micturition syncope
History of postural hypotension
Peri-operative period in ocular surgery
Severe hepatic impairment

Precautions and Warnings

Cataract
Glaucoma
Mild hepatic impairment
Renal impairment - creatinine clearance below 10ml/minute

Advise hypotension/syncope may affect ability to drive/operate machinery
Contains propylene glycol: may cause irritation
Contains soya or soya derivative
Capsule contents may cause irritation of the oropharyngeal mucosa
Absorbed by skin - avoid contact with leaking capsules
Establish new PSA baseline at 6 months and monitor PSA regularly thereafter
Investigate any sustained increase in PSA during treatment
Regular examination of prostate advised to exclude prostatic cancer
Advise patient to report any breast changes e.g. lumps, pain or discharge
Advise patient to sit or lie down at first signs of orthostatic hypotension
Intraoperative Floppy Iris Syndrome has been reported in cataract surgery
Intraoperative Floppy Iris Syndrome has been reported in glaucoma surgery
Discontinue 1 to 2 weeks prior to cataract surgery
Discontinue if angioedema occurs
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

Dutasteride causes a decrease (of approximately 50%) in serum prostate-specific antigen (PSA) levels after 6 months of treatment. Increase from the lowest PSA level whilst on dutasteride with tamsulosin may indicate presence of prostate cancer or non-compliance to therapy, which should be evaluated. Previous PSA values should be sought for comparison when interpreting the PSA value for a patient.

During the pre-operative assessment prior to cataract surgery, surgeons must ascertain whether the patients have ever received tamsulosin. If they have, appropriate measures should be in place to manage any occurrence of Intraoperative Floppy Iris Syndrome (IFIS) during the procedure.

Breast cancer has been reported in men taking dutasteride in clinical trials and during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of dutasteride.

Incidence of cardiac failure was higher among subjects taking the combinations of dutasteride and an alpha blocker, primarily tamsulosin, than it was among subjects not taking the combination.

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, inhibits the development of the external genitalia of the foetus.

Small amounts of dutasteride have been found in the semen of men undergoing treatment. Animal studies have shown that it is unlikely to have any adverse effect on a male foetus if the mother is exposed to the semen of a man undergoing treatment with dutasteride (the greatest risk is within the first 16 weeks of pregnancy). However, it is recommended that a condom is used in order to avoid exposure to pregnant or potentially pregnant women.

Animal studies showed no evidence of foetal harm after administration of tamsulosin.

Lactation

Not indicated for use in women.

It is not known whether dutasteride or tamsulosin 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

Abnormal ejaculation
Allergic reaction
Alopecia
Angioedema
Asthenia
Breast enlargement
Breast tenderness
Cardiac failure
Constipation
Diarrhoea
Dizziness
Ejaculation disorders
Headache
Hypertrichosis
Impotence
Increased risk of breast cancer
Intraoperative floppy iris syndrome
Nausea
Oedema
Palpitations
Postural hypotension
Priapism
Pruritus
Rash
Reduced libido
Reduction in sperm count and volume
Rhinitis
Stevens-Johnson syndrome
Syncope
Urticaria
Vomiting

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: June 2020

Reference Sources

Summary of Product Characteristics: Combodart 0.5mg/0.4mg capsules. GlaxoSmithKline UK Ltd. Revised March 2020.

Summary of Product Characteristics: Dutrozen 0.5mg/0.4mg capsules. Zentiva Pharma UK Ltd. Revised February 2020.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 June 2020