HYTRIN TABLET 5 MG [SIN11676P]

Product Info

HYTRIN TABLET 5 MG

[SIN11676P]

INDICATIONS
Hytrin (terazosin hydrochloride) is indicated for the relief of the manifestations of mild to moderate benign prostatic hyperplasia (BPH). Treatment should be stopped if patients have not responded after three months of therapy.

Terazosin is also indicated in the treatment of hypertension. It can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.

DOSAGE AND ADMINISTRATION
The dose of terazosin should be adjusted according to the patient's individual 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:
Benign Prostatic Hyperplasia (BPH):
The dose may be slowly increased to achieve the desired clinical response in BPH patients. The usual recommended dose range is 5 to 10 mg administered once a day. Treatment should commence with one tablet of 1 mg taken at bedtime for the first 4 days, then every morning for the next 3 days. For the next seven days, the dosage is one tablet of 2 mg every morning. In the third week, the dosage is increased to one tablet of 5 mg every morning. As from the fourth week, a maintenance dosage of 5–10 mg is taken daily each morning.

Urine flow rate measured approximately 24 hours after the last dose has shown that the beneficial effect in BPH persists for the recommended dosing interval. Symptom improvements have been detected as early as two weeks after starting treatment with terazosin. Improvements in flow rate may be seen somewhat later.

Maximal benefit appears to occur after 3 to 6 months of treatment, but it appears that there is little to be gained by continuing treatment for more than 6 months if there has been no clinical response. Efficacy has been demonstrated in clinical studies of up to 18 months but data on longer term use is not yet available. If terazosin administration is discontinued for several days or longer, therapy should be reinstituted using the initial dosing regimen.

Hypertension: 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. Doses over 20 mg do not appear to provide further blood pressure effect and doses over 40 mg have not been studied. Blood pressure should be monitored at the end of the dosing interval to be sure control is maintained throughout the interval. It may also be helpful to measure blood pressure 2–3 hours after dosing to see if the maximum and minimum responses are similar, and to evaluate symptoms such as dizziness or palpitations which can result from excessive hypotensive response. If the response is substantially diminished at 24 hours, an increased dose or use of a twice daily regimen can be considered. 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.

CONTRAINDICATIONS
Terazosin is contraindicated in patients known to be hypersensitive to terazosin hydrochloride or its analogues.