TERAZOSIN HYDROCHLORIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

State of Florida DOH Central Pharmacy

INN (Tên quốc tế):

TERAZOSIN HYDROCHLORIDE

Thành phần:

TERAZOSIN HYDROCHLORIDE 1 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Terazosin hydrochloride is 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 hydrochloride. The long-term effects of terazosin hydrochloride on the incidence of surgery, acute urinary obstruction or other complications of BPH are yet to be determined. Terazosin hydrochloride is 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 hydrochloride capsules are contraindicated in patients known to be hypersensitive to terazosin hydrochloride.

Tóm tắt sản phẩm:

Terazosin Hydrochloride Capsules, 1 mg, 2 mg, 5 mg and 10 mg contain 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin hydrochloride anhydrous, respectively. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 15° to 30°C (59° to 86°F). [See USP for Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense Patient Information Leaflet with each prescription.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

TERAZOSIN HYDROCHLORIDE - TERAZOSIN HYDROCHLORIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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TERAZOSIN HYDROCHLORIDE CAPSULES
1 MG, 2 MG, 5 MG AND 10 MG
RX ONLY
1
DESCRIPTION
Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking
agent, is a quinazoline derivative
represented by the following structural formula, molecular formula and
chemical name:
Piperazine,
1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-furanyl)carbonyl]-,
monohydrochloride, anhydrous.
Terazosin hydrochloride is a white, crystalline substance, freely
soluble in water and isotonic saline
and has a molecular weight of 459.93. Each terazosin hydrochloride
capsule, for oral administration,
contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin
hydrochloride anhydrous. Each capsule
contains the following 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, gelatine, 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
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