TERAZOSIN HYDROCHLORIDE- terazosin capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International Name):

TERAZOSIN HYDROCHLORIDE

Composition:

TERAZOSIN 1 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 Hydrochloride Capsules are available as: 1 mg: White capsules imprinted GG 621 in black ink, filled with white powder are supplied as follows: NDC 0615-1337-39 blisterpacks of 30 capsules 2 mg: Yellow capsules imprinted GG 622 in black ink, filled with white powder.  5 mg: Pink capsules imprinted GG 623 in black ink, filled with white powder. Store at 20°-25°C (68°-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 CAPSULE
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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TERAZOSIN HYDROCHLORIDE CAPSULES
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 hydrochloride
capsules, for oral administration, are
supplied in four dosage strengths containing terazosin hydrochloride
equivalent to 1 mg, 2 mg, 5 mg, or
10 mg of terazosin. Inactive ingredients: Crospovidone, lactose
(monohydrate), magnesium stearate, and
microcrystalline cellulose. 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, pharmaceutical glaze, propylene glycol,
silicon dioxide, sodium lauryl sulfate,
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 abu