TERAZOSIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERAZOSIN HYDROCHLORIDE (UNII: D32S14F082) (TERAZOSIN - UNII:8L5014XET7)

Available from:

Aidarex Pharmaceuticals LLC

INN (International Name):

TERAZOSIN HYDROCHLORIDE

Composition:

TERAZOSIN 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terazosin Capsules, USP 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, USP. The long-term effects of Terazosin Capsules, USP on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin Capsules, USP are also indicated for the treatment of hypertension. It 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.

Product summary:

Terazosin Capsules, USP are available for oral administration as 1 mg, 2 mg and 10 mg capsules. Terazosin Capsules, USP 1 mg: Hard gelatin capsules with a beige opaque body and a beige opaque cap. “APO 115” is imprinted on each capsule in black ink; supplied in bottles of 30 (NDC 33261-0211-30). Terazosin Capsules, USP 2 mg: Hard gelatin capsules with a yellow opaque body and a yellow opaque cap. “APO 116” is imprinted on each capsule in black ink; supplied in bottles of 30 (NDC 33261-0212-30). Terazosin Capsules, USP 10 mg: Hard gelatin capsules with a blue opaque body and a blue opaque cap. “APO 118” is imprinted on each capsule in black ink; supplied in bottles of 30 (NDC 33261-0870-30). Recommended storage: Store at 20º to 25°C (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. APOTEX INC. TERAZOSIN CAPSULES, USP 1 MG, 2 MG AND 10 MG Repackaged By: Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Revised: June 2011 Revision 2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERAZOSIN- TERAZOSIN CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
TERAZOSIN CAPSULES, 1MG, 2MG, 5MG AND 10 MG
DESCRIPTION
Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking
agent, is a quinazoline derivative
represented by the following chemical name and structural formula:
(RS)-Piperazine, 1-(4-amino-6,7-
dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-,
monohydrochloride, dihydrate.
Terazosin hydrochloride is a white, crystalline substance, freely
soluble in water and isotonic saline
and has a molecular weight of 459.93. Terazosin Capsules, USP 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
The 1 mg, 2 mg, 5 mg and 10 mg capsules contain the following inactive
ingredients: lactose
monohydrate, starch, stearic acid and talc. The 1 mg, 2 mg, 5 mg and
10 mg capsule imprinting ink
contains ammonium hydroxide, black iron oxide, potassium hydroxide,
propylene glycol and shellac.
The 1 mg capsule shell contains black iron oxide, gelatin, titanium
dioxide and yellow iron oxide.
The 2 mg capsule shell contains D&C yellow #10, FD&C red #40, gelatin
and titanium dioxide.
The 5 mg capsule shell contains D&C red #28, FD&C red #40, gelatin and
titanium dioxide.
The 10 mg capsule shell contains D&C red #28, D&C yellow #10, FD&C
blue #1, gelatin and titanium
dioxide.
USP Dissolution Test 2
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 m