Tamsulosin hydrochloride oral modified release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of tamsulosin hydrochloride.
Benign prostatic hyperplasia
Treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Dysfunctional voiding of urine
Treatment of dysfunctional voiding in children.
400 micrograms once daily.
The 'Pharmacy' product is licensed for men aged 45 to 75.
Dysfunctional voiding (unlicensed)
Children aged 12 to 18 years
400 micrograms once daily.
Additional Dosage Information
Tamsulosin hydrochloride should not be used in combination with strong inhibitors of CPY3A4 in patients with poor metaboliser CYP2D6 phenotype.
History of postural hypotension
Peri-operative period in ocular surgery
Severe hepatic impairment
Precautions and Warnings
Glucose-galactose malabsorption syndrome
Renal impairment - creatinine clearance below 10ml/minute
Advise ability to drive/operate machinery may be affected by side effects
Advise hypotension/syncope may affect ability to drive/operate machinery
Not all available brands are licensed for all age groups
Some brands contain Carmoisine (E122) - can trigger allergic reactions
Some brands contain Quinoline Yellow (E104) : May cause allergic reactions
Some formulations contain lactose
Some formulations contain Ponceau 4R (E124)-may cause allergic reactions
Some formulations contain sunset yellow (E110); may cause allergic reaction
Perform digital rectal examination & PSA prior to and following treatment
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 1 to 2 weeks prior to glaucoma surgery
Discontinue if angioedema occurs
May have additive effects with antihypertensives
Advise patient grapefruit products may increase plasma level
Patients undergoing cataract or glaucoma surgery who are taking tamsulosin hydrochloride or have received this drug previously may develop Intraoperative Floppy Iris Syndrome (IFIS), which is a variant of small pupil syndrome. IFIS may cause complications during surgery. Tamsulosin therapy should not be initiated in patients who are scheduled to undergo ocular surgery.
During the pre-operative assessment prior to ocular surgery, surgeons must ascertain whether the patient has ever received tamsulosin hydrochloride. If they have, appropriate measures should be in place to manage any occurrence of IFIS during the procedure.
Additional warnings for the 'Pharmacy' product
Tamsulosin is not suitable for self-medication in men with the following conditions:
History of prostate surgery
Symptoms suggestive of urinary tract infection (dysuria, haematuria, cloudy urine, fever) or urinary tract infection in the last 3 months.
Tamsulosin should not be self-prescribed by men where symptoms of BPH have been present for less than 3 months.
Pregnancy and Lactation
Not indicated for use in women.
Not indicated for use in women.
Advise patients that capsules and tablets should be swallowed whole (not chewed, crushed or broken).
For the 'Pharmacy' product advise patients that if symptoms have not improved within 14 days of starting treatment, or have become worse, the patient should stop treatment and consult a doctor. Advise the patient to see a doctor within 6 weeks of starting treatment to assess for symptoms of BPH. Every 12 months patients should be advised to consult a doctor for a clinical review.
Advise patient grapefruit products may increase plasma levels of tamsulosin.
Patients should be aware that dizziness, drowsiness, blurred vision and syncope can occur which may effect the ability to drive or operate machinery.
Failure of ejaculation
Intraoperative floppy iris syndrome
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 ).
Last Full Review Date: January 2020
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NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 March 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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