Tamsulosin hydrochloride oral modified release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of tamsulosin hydrochloride.
Drugs List
Therapeutic Indications
Uses
Benign prostatic hyperplasia
Treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
Unlicensed Uses
Dysfunctional voiding of urine
Treatment of dysfunctional voiding in children.
Dosage
Adults
400 micrograms once daily.
The 'Pharmacy' product is licensed for men aged 45 to 75.
Children
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.
Contraindications
Females
Micturition syncope
History of postural hypotension
Peri-operative period in ocular surgery
Severe hepatic impairment
Precautions and Warnings
Cataract
Galactosaemia
Glaucoma
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:
Postural hypotension
Cardiac disease
Renal impairment
Hepatic impairment
Uncontrolled diabetes
History of prostate surgery
Urinary incontinence
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
Pregnancy
Not indicated for use in women.
Lactation
Not indicated for use in women.
Counselling
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.
Side Effects
Angioedema
Arrhythmias
Asthenia
Atrial fibrillation
Blurred vision
Constipation
Diarrhoea
Dizziness
Drowsiness
Dry mouth
Dyspnoea
Ejaculation disorders
Epistaxis
Erythema multiforme
Exfoliative dermatitis
Failure of ejaculation
Headache
Hypersensitivity reactions
Intraoperative floppy iris syndrome
Nausea
Oedema
Palpitations
Postural hypotension
Priapism
Pruritus
Rash
Retrograde ejaculation
Rhinitis
Stevens-Johnson syndrome
Syncope
Tachycardia
Urticaria
Visual disturbances
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: January 2020
Reference Sources
Summary of Product Characteristics: Contiflo XL 400 microgram prolonged-release capsules. Ranbaxy (UK) Ltd. Revised October 2019.
Summary of Product Characteristics: Cositam XL 400 microgram prolonged-release tablets. Consilient Health Ltd. Revised December 2013.
Summary of Product Characteristics: Faramsil 400 microgram prolonged-release tablets. Sandoz Ltd. Revised December 2017.
Summary of Product Characteristics: Flectone XL 400 microgram prolonged release tablets. Teva UK Ltd. Revised March 2014.
Summary of Product Characteristics: Flomax Relief MR. Sanofi. Revised July 2018.
Summary of Product Characteristics: Flomaxtra XL 400 micrograms film-coated prolonged release tablet. Astellas Pharma Ltd. Revised November 2019.
Summary of Product Characteristics: Losinate MR 400 microgram modified-release capsules. Synthon BV. Revised September 2015.
Summary of Product Characteristics: Omsula 0.4mg prolonged-release capsules, hard. Gedeon Richter (UK) Ltd. Revised January 2021.
Summary of Product Characteristics: Pamsvax XL 400 micrograms capsules. Accord-UK Ltd. November 2019.
Summary of Product Characteristics: Pinexel PR 400 micrograms prolonged-release hard capsules. Wockhardt UK Ltd. Revised January 2017.
Summary of Product Characteristics: Prosurin XL 400 micrograms capsules. Generics UK T/A Mylan. Revised May 2016.
Summary of Product Characteristics: Tabphyn MR 400 microgram. Genus Pharmaceuticals Ltd. Revised January 2015.
Summary of Product Characteristics: Tamfrex XL 400 microgram capsules. Aurobindo Pharma-Milpharm Ltd. Revised February 2019.
Summary of Product Characteristics: Tamsumac 0.4mg prolonged release capsules, hard. Macleods Pharma UK Limited. Revised June 2016.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 16 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.