Product Description.:
TL 383, TL 383
capsule , gray , oblong oblong
OpaqueBlack ink
HYTRIN (terazosin hydrochloride), an alpha-1-selective adrenoceptor blocking agent
Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 459.93. HYTRIN tablets (terazosin hydrochloride tablets) for oral ingestion are supplied in four dosage strengths containing terazosin hydrochloride equivalent to 1 mg, 2 mg, 5 mg, or 10 mg of terazosin.
Inactive Ingredients
1 mg tablet: corn starch, lactose, magnesium stearate, povidone and talc.
2 mg tablet: corn starch, FD&C Yellow No. 6, lactose, magnesium stearate, povidone and talc.
5 mg tablet: corn starch, iron oxide, lactose, magnesium stearate, povidone and talc.
10 mg tablet: corn starch, D&C Yellow No. 10, FD&C Blue No. 2, lactose, magnesium stearate, povidone and talc.
INDICATIONS
HYTRIN (terazosin hydrochloride) is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH). There is a rapid response, with approximately 70% of patients experiencing an increase in urinary flow and improvement in symptoms of BPH when treated with HYTRIN. The long-term effects of HYTRIN on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined.
HYTRIN tablets are also indicated for the treatment of hypertension. HYTRIN tablets can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents.
SIDE EFFECTS
Benign Prostatic Hyperplasia
The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1% and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.
