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Drug Class Description
a1A adrenoreceptor antagonistGeneric Name
Tamsulosin HydrochlorideDrug Description
Modified-release capsule, hard Orange/olive-green capsule, with the black printed mark TSL 0.4 and with a black stripe at both ends. The capsules contain white to off-white pellets.Presentation
One capsule contains 0.4 mg of tamsulosin hydrochloride.Indications
Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Adult Dosage
One capsule a day after breakfast or the first meal of the day. The capsule is swallowed whole with a glass of water while standing or sitting (not lying down).
The capsule should not be broken or pulled apart as this may have an effect on the release of the long-acting active ingredient. Tamsulosin is intended for males only.
Contra Indications
Hypersensitivity to tamsulosin, including drug-induced angio-oedema, or to any of the excipients. Orthostatic hypotension observed earlier (history of orthostatic hypotension). Severe hepatic insufficiency.
Special Precautions
The use of tamsulosin may lower blood pressure, which in rare cases may cause fainting. If initial symptoms of orthostatic hypotension start to appear (dizziness, weakness), then the patient should sit or lie down until the symptoms have gone.
The patient should be examined before commencement of therapy with tamsulosin to exclude the presence of other conditions that can produce similar symptoms to those of BPH. The prostate should be examined via the rectum and, if necessary, the PSA count determined prior to commencement of treatment and again later at regular intervals.
The treatment of severely renally impaired patients (creatinine clearance of < 10 ml/min) should be approached with caution as these patients have not been studied. Angio-oedema has been rarely reported after the use of tamsulosin. Treatment should be discontinued immediately, the patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered.
Interactions
No interactions have been observed when tamsulosin has been given concomitantly with atenolol, enalapril, nifedipine or theophylline. Concomitant cimetidine raises, and concomitant furosemide lowers, plasma concentrations of tamsulosin but, as the concentration of tamsulosin remains within the normal range, posology need not be altered.
Tamsulosin has not been found to interact with amitriptyline, salbutamol, glibenclamide or finasteride during in vitro studies with liver microsomal fractions (representing the cytochrome P450-linked metabolising enzyme system). Diclofenac and Warfarin may increase the elimination rate of tamsulosin. Concurrent administration with another a1-adrenoreceptor antagonist may lower blood pressure.
Adverse Reactions
Common >1/100, <1/10) Uncommon >1/1 000, <1/100) Rare >1/10 000, <1/1 000) Very rare (<1/10 000) Nervous system disorders Dizziness Headache Syncope Cardiac disorders Tachycardia Vascular disorders Orthostatic hypotension Respiratory, thoracic and mediastinum-related disorders Rhinitis Gastrointestinal disorders Constipation, diarrhoea, nausea, vomiting Skin and subcutaneous tissue disorders Rash, itching, urticaria Angio-oedema Reproductive systems and breast disorders Abnormal ejaculation Priapism General disorders and administration site conditions Asthenia
Manufacturer
Alpharma LimitedDrug Availability
(POM)Updated
17 August 2009