Presentation
Uromax capsule: Standard brown opaque cap and buff opaque body capsule; each capsule contains Tamsulosin Hydrochloride USP 0.4mg modified release pellets.
Indication
Treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).
Dosage and administration
Tamsulosin Hydrochloride 0.4mg (one Uromax capsule) daily, to be taken after breakfast. The dose may be increased after 2 to 4 weeks, if necessary, to tamsulosin Hydrochloride 0.8mg (two Uromax capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4mg or 0.8mg dose, therapy should be started again with the 0.4mg Tamsulosin Hydrochloride (one Uromax capsule) once daily dose. The capsule should be swallowed whole with a drink of water (about 150ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with modified release of the active ingredient.
Contra-indications, warnings, etc.
Contra-indications
Tamsulosin is contra-indicated in patients with hypersensitivity to tamsulosin.
Warnings
Rarely, transient postural symptoms have occured during orthostatic provocationtesting after the first dose. Use in patients with micturition syncope is not advised.
Drug interactions
Concurrent administration of other alfa 1-adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant cimetidine brings about a rise and frusemide a fall in plasma levels of tamsulosin, but as levels remain within the normal range posology need not be changed. No interactions at the level of hepatic metabolism have been seen during in vitro studies with liver microsomal fractions (representative of the cytochrome P450-linked drug metabolising enzyme system), involving amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin.
Use in pregnancy and laction
Not recommended in pregnancy and lactation. Effects on ability to drive and use machines: no data is available on whether tamsulosin adversely affects the ability to drive or operate machines. However, in this respect, patients should be aware of the fact that dizziness can occur.
Side-effects
The following adverse reactions have been reported during the use of tamsulosin: dizziness, abnormal ejaculation and; less frequently headache, asthenia, postural hypotension and palpitations.
Overdose
No case of acute overdosage have been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovasculer support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders, and when necessary, vasopressors could be emplyed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.
Pharmaceutical precautions
Store in a cool and dry place, protected from light
Packaging quantity
Uromax capsule: Cartons containing 28 capsules in alu-alu blister.
