TERAZOSIN- terazosin hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

TERAZOSIN HYDROCHLORIDE

Composition:

TERAZOSIN 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERAZOSIN- TERAZOSIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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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 and bladder
neck. The