TERAZOSIN HYDROCHLORIDE- 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:

Major Pharmaceuticals

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. Terazosin capsules, USP 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 as: 1 mg: White capsules imprinted GG 621 in black ink, filled with white powder are supplied as follows: Carton of 100 tablets (10 capsules each blister pack x 10) NDC 0904-6126-61 2 mg: Yellow capsules imprinted GG 622 in black ink, filled with white powder are supplied as follows: Carton of 100 tablets (10 capsules each blister pack x 10) NDC 0904-6127-61 5 mg: Pink capsules imprinted GG 623 in black ink, filled with white powder are supplied as follows: Carton of 100 tablets (10 capsules each blister pack x 10) NDC 0904-6128-61 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERAZOSIN HYDROCHLORIDE- TERAZOSIN HYDROCHLORIDE CAPSULE
MAJOR PHARMACEUTICALS
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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 and structural formula:
(RS)-Piperazine, 1-(4-amino-6,7-
dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-furanyl)carbonyl]-,
monohydrochloride. It has the
following structural formula:
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 administration, are supplied in
four dosage strengths containing terazosin hydrochloride, USP
equivalent to 1 mg, 2 mg, 5 mg, or 10
mg of terazosin. Inactive ingredients: Crospovidone, lactose
(monohydrate), magnesium stearate, and
microcrystalline cellulose. May contain corn starch. The capsule
shells and imprinting inks contain: D &
C Yellow #10 Aluminum Lake, FD & C Blue #1 Aluminum Lake, FD & C Blue
#2 Aluminum Lake, FD
& C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac,
synthetic black iron oxide, and
titanium dioxide. The 5 MG also contains: D & C Red #28.
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 bladd