Composition:

PROSTA – NOR 2: Each tablet contains terazosin hydrochloride 2.188 mg equivalent to terazosin Base 2 mg.

PROSTA – NOR 5: Each tablet contains terazosin hydrochloride 5.430 mg equivalent to terazosin Base 5 mg.

PROSTA – NOR 10: Each tablet contains terazosin hydrochloride 10.941 mg equivalent to terazosin Base 10 mg.

Pharmacodynamics:

Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent.

There are relatively few alpha-1 adrenoceptors in the bladder body, terazosin is able to reduce the bladder outlet obstruction without affecting bladder contractility.

Terazosin causes a decrease in blood pressure by decreasing total peripheral vascular resistance. The vasodilatory hypotensive action of terazosin appears to be produced mainly by blockade of alpha-1 adrenoceptors. Terazosin decreases blood pressure gradually within 15 minutes following oral administration.

Indications:

Terazosin hydrochloride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH), also indicated for the treatment of hypertension.

Terazosin tablets can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

Dosage and Administration:

Benign Prostatic Hyperplasia:

Initial Dose: 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded as an initial dose.

Subsequent Doses: The dose should be increased in a stepwise fashion to 2 mg, 5 mg, or 10 mg once daily to achieve the desired improvement of symptoms and/or flow rates. Doses of 10 mg once daily are generally required for the clinical response. Therefore, treatment with 10 mg for a minimum of 4 – 6 weeks may be required to assess whether a beneficial response has been achieved.

Hypertension:

The dose of terazosin and the dose interval (12 or 24 hours) should be adjusted according to the patient’s individual blood pressure response. The following is a guide to its administration:

Initial Dose: 1 mg at bedtime is the starting dose for all patients, and this dose should not be exceeded. This initial dosing regimen should be strictly observed to minimize the potential for severe hypotensive effects.

Subsequent Doses: The dose may be slowly increased to achieve the desired blood pressure response. The usual recommended dose range is 1 mg to 5 mg administered once a day; however, some patients may benefit from doses as high as 20 mg per day.

If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen. In clinical trials, except for the initial dose, the dose was given in the morning.

Packaging:

PROSTA – NOR 2: A pack of 20 or 100 tablets.

PROSTA – NOR 5: A pack of 20 or 100 tablets.

PROSTA – NOR 10: A pack of 20 tablets.