Country: United States
Language: English
Source: NLM (National Library of Medicine)
Terazosin Hydrochloride (UNII: D32S14F082) (Terazosin - UNII:8L5014XET7)
Jubilant Cadista Pharmaceuticals Inc.
Terazosin Hydrochloride
Terazosin 1 mg
ORAL
PRESCRIPTION DRUG
Terazosin capsules are 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 terazosin capsules. The long-term effects of terazosin capsules on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin capsules are also indicated for the treatment of hypertension. Terazosin capsules can be used alone or in combination with other antihypertensive agents such as diuretics or beta-adrenergic blocking agents. Terazosin capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.
Terazosin Capsules are available in four dosage strengths: 1 mg Terazosin Capsules, USP are available as Size 3 iron gray opaque capsules printed "TL 383" axially in black ink on body and cap. Bottles of 90: NDC 59746-383-90 Bottles of 100: NDC 59746-383-06 Bottles of 500: NDC 59746-383-09 Bottles of 1000: NDC 59746-383-10 2 mg Terazosin Capsules, USP are available as Size 3 ivory opaque capsules printed "TL 384" axially in black ink on body and cap. Bottles of 90: NDC 59746-384-90 Bottles of 100: NDC 59746-384-06 Bottles of 500: NDC 59746-384-09 Bottles of 1000: NDC 59746-384-10 5 mg Terazosin Capsules, USP are available as Size 3 orange opaque capsules printed "TL 385" axially in black ink on body and cap. Bottles of 90: NDC 59746-385-90 Bottles of 100: NDC 59746-385-06 Bottles of 500: NDC 59746-385-09 Bottles of 1000: NDC 59746-385-10 10 mg Terazosin Capsules, USP are available as Size 3 light green opaque capsules printed "TL 386" axially in black ink on body and cap. Bottles of 90: NDC 59746-386-90 Bottles of 100: NDC 59746-386-06 Bottles of 500: NDC 59746-386-09 Bottles of 1000: NDC 59746-386-10 Dispense in a tight, light-resistant container as defined in the USP. Recommended storage: Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Rx only Revised 01/2018 Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA For additional copies of the printed patient information/medication guide, please visit www.cadista.com or call 1-800-313-4623.
Abbreviated New Drug Application
TERAZOSIN - TERAZOSIN HYDROCHLORIDE CAPSULE JUBILANT CADISTA PHARMACEUTICALS INC. ---------- TERAZOSIN CAPSULES, USP DESCRIPTION Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative represented by the following chemical name,molecular formula and structural formula: (RS)-Piperazine, 1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-, monohydrochloride.C H ClN O Terazosin hydrochloride is a white, crystalline substance, freely soluble in water and isotonic saline and has a molecular weight of 423.93. Each capsule, for oral administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochlolde. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, and pregelatinized starch. The gelatin capsule contains gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide. The 1 mg shell also contains black iron oxide; the 2 mg capsule shell also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C Yellow #10, FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains FD&C Green #3 and D&C Yellow#10. CLINICAL PHARMACOLOGY PHARMACODYNAMICS A. Benign Prostatic Hyperplasia (BPH) The symptoms associated with BPH are related to bladder outlet obstruction, which is comprised of two underlying components: a static component and a dynamic component. The static component is a consequence of an increase in prostate size. Over time, the prostate will continue to enlarge. However, clinical studies have demonstrated that the size of the prostate does not correlate with the severity of BPH symptoms or the degree of urinary obstruction. The dynamic component is a function of an increase in smooth muscle tone in the prostate and bladder neck, leading to constriction of the bladder outlet. Smooth muscle tone is mediated by sympathetic nervous stimulation of alpha-1 adrenoceptors, which are abundant in the prostate, prostatic capsule a Read the complete document