Uropass 0.4 mg cap

Uropass 0.4 mg cap

DESCRIPTION

Tamsulosin, a selective alpha1 adrenoceptor blocking agent, exhibits its selectivity for alpha1A adrenoceptors in human prostate. Blockade of these adrenoceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow rate and a reduction in symptoms of BPH. Absorption of Tamsulosin

Hydrochloride capsules 0.4 mg is essentially complete (90%) following oral administration under fasting condition. The time to maximum concentration (Tmax) is reached by four to five hours under fasting conditions and by six to seven hours when administered with food.

Tamsulosin Hydrochloride is extremely bound to human plasma protein (94% to 99%). Tamsulosin Hydrochloride is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine as unchanged form. Following intravenous or oral administration of an immediate-release formulation the elimination halflife of Tamsulosin Hydrochloride in plasma ranges from five to seven hours. Because of the absorption rate controlled pharmacokinetics with capsules, the apparent half-life of the Tamsulosin Hydrochloride is approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target population.

COMPOSITION

Each capsule contains Tamsulosin HCl INN 0.4 mg as modified release pellets.

INDICATION

Treatment of the signs and symptoms of Benign Prostatic Hyperplasia (BPH).

DOSAGE AND ADMINISTRATION

Uropass 0.4 mg capsule is recommended once daily as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately half an hour following the same meal each day. For those patients who fail to respond to the 0.4 mg dose after two to four weeks of treatment, the dose of Uropass capsules can be increased to 0.8 mg (two capsules) once daily. If the administration of the dose either 0.4 mg or 0.8 mg is discontinued or interrupted for several days, therapy should be started again with the 0.4 mg once daily dose.

SIDE EFFECTS

The side effects reported during the use of Uropass (Tamsulosin HCl) are : dizziness, abnormal ejaculation and less frequently headache, asthenia, postural hypotension and palpitations.

CONTRAINDICATIONS

Uropass (Tamsulosin HCl) capsule is contraindicated in patients known to be hypersensitive to Tamsulosin HCl or any other components of the product.

PRECAUTION

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).

USE IN PREGNANCY AND LACTATION

Not indicated for use in woman.

PEDIATRIC USE

Uropass (Tamsulosin HCl) capsules are not indicated for use in children.

DRUG INTERACTIONS

Concurrent administration of other alpha1 adrenoceptor antagonists could lead to hypotensive effects. No interactions have been seen when Tamsulosin was given concomitantly with either atenolol, enalapril or nifedipine. Concomitant use with cimetidine brings about a rise and frusemide a fall in plasma levels of Tamsulosin, but as levels remain within the normal range, posology does not need to be changed. No interactions at the level of hepatic metabolism have been seen during in-vitro studies with live 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 Tamsuloisn.

OVERDOSAGE

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 heart rate can be 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 should also be applied.

Dialysis is unlikely to be of help as Tamsulosin HCl 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.

SUPPLY

Each box contains 5 x 4 capsules in alu-alu blister strips.