Generic: Tamsulosin Hydrochloride  |  Dosage Form: Capsule (Modified Release)  |  Manufacturer: Chemist Laboratories Ltd.

Indications

Tamsulosin Hydrochloride is indicated for the treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH).

Dosage & Administration

Tamsulosin Hydrochloride 0.4 mg (one capsule) daily, to be taken after meal at night. The dose may be increased after 2 to 4 weeks, if necessary, to Tamsulosin Hydrochloride 0.8 mg (two capsules) once daily. If Tamsulosin Hydrochloride administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the Tamsulosin Hydrochloride 0.4 mg (one capsule) once daily dose. The capsule should be swallowed whole with a glass of water (about 150 ml) in the standing or sitting position. The capsule should not be crunched or chewed, as this will interfere with the modified release of the active ingredient.

Interaction

Concurrent administration of other alfa1-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-metabolizing enzyme system), involving amitriptyline, salbutamol, glibenclamide, and finasteride. Diclofenac and warfarin, however, may increase the elimination rate of Tamsulosin.

Contraindications

Tamsulosin hydrochloride is contraindicated in patients with hypersensitivity to it; history of orthostatic hypotension; severe hepatic insufficiency.

As with other alpha1 blockers, a reduction in blood pressure can occur in individual cases during treatment with Tamsulosin, as a result of which, rarely, syncope can occur, at the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared. And they should be cautioned to avoid situations where injury could result (like driving, operating machinery or performing hazardous tasks).

Before therapy with Tamsulosin is initiated the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as Benign Prostatic hyperplasia. Digital rectal examination and when the necessary determination of Prostate Specific Antigen (PSA) should be performed before treatment and at regular intervals afterwards.

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.

Precautions & Warnings

Rarely, transient postural symptoms have occurred during orthostatic provocation testing after the first dose. Use in patients with micturition syncope is not advised.

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.

Overdose Effects

No case of acute overdosage has been reported. However, acute hypotension is likely to occur after overdosage in which case cardiovascular support should be given. Blood pressure can be restored and the 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 employed. 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.

Therapeutic Class

BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

Store in a cool and dry place, below 30°C, protected from light.