TERAZOSIN capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. The long term effects of terazosin 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. They 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.

Resumen del producto:

Terazosin Capsules, USP 1 mg, are available as size 3 white opaque cap and body hard gelatin capsules, imprinted with "735" on the cap and "1 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-735-01 and NDC # 23155-735-10. Terazosin Capsules, USP 2 mg, are available as size 3 yellow opaque cap and white opaque body hard gelatin capsules, imprinted with "736" on the cap and "2 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-736-01 and NDC # 23155-736-10. Terazosin Capsules, USP 5 mg, are available as size 3 swedish orange opaque cap and white opaque body hard gelatin capsules, imprinted with "737" on the cap and "5 mg" on the body in black ink, packaged in bottles of 100 and 1000 capsules, NDC # 23155-737-01 and NDC # 23155-737-10. Terazosin Capsules, USP 10 mg, are available as size 3 aqua blue opaque cap and white opaque body hard gelatin capsules, imprinted with "738" on the cap and "10 mg" on the body in black, packaged in bottles of 100 and 1000 capsules, NDC # 23155-738-01 and NDC # 23155-738-10. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT AND MOISTURE Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784)   Revised: 08/2021

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

TERAZOSIN - terazosin capsule
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
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PATIENT INFORMATION ABOUT
TERAZOSIN CAPSULES, USP
(ter ay'zoe sin)
Rx only
When used to treat HYPERTENSION or BENIGN PROSTATIC HYPERPLASIA (BPH)
Please read this leaflet before you start taking terazosin capsules.
Also, read it each time you get a new
prescription. This is a summary and should NOT take the place of a
full discussion with your doctor who has
additional information about terazosin capsules. You and your doctor
should discuss terazosin capsules and
your condition before you start taking it and at your regular
check-ups.
Terazosin capsules are used to treat high blood pressure
(hypertension). Terazosin capsules are also used to
treat benign prostatic hyperplasia (BPH) in men. This leaflet
describes terazosin capsules as a treatment for
hypertension or BPH.
What is hypertension (high blood pressure)?
Blood pressure is the tension of the blood within the blood vessels.
If blood is pumped too forcefully, or if
the blood vessels are too narrow, the pressure of the blood against
the walls of the vessels rises.
If high blood pressure is not treated, over time, the increased
pressure can damage blood vessels or it can
cause the heart to work too hard and may decrease the flow of blood to
the heart, brain, and kidneys. As a
result, these organs may become damaged and not function correctly. If
high blood pressure is controlled,
this damage is less likely to happen.
Treatment options for hypertension
Non-drug treatments are sometimes effective in controlling mild
hypertension. The most important lifestyle
changes to lower blood pressure are to lose weight, reduce salt, fat,
and alcohol in the diet, quit smoking, and
exercise regularly. However, many hypertensive patients require one or
more ongoing medications to control
their blood pressure. There are different kinds of medications used to
treat hypertension. Your doctor has
prescribed terazosin capsules for you.
What Terazosin Capsules do to treat hyperten

Fitxa tècnica

TERAZOSIN - TERAZOSIN CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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TERAZOSIN CAPSULES, USP
DESCRIPTION
Terazosin hydrochloride, USP an alpha-1-selective adrenoceptor
blocking agent, is a
quinazoline derivative. The chemical name for terazosin hydrochloride,
USP is (RS)-
Piperazine,
1-(4-Amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetra-hydro-2-
furanyl)carbonyl]-, monohydrochloride, dihydrate. It has the following
structural
formula:
Terazosin hydrochloride, USP is a white, crystalline substance, freely
soluble in water
and isotonic saline. Each capsule for oral administration, contains
terazosin
hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg or 10 mg terazosin.
In addition, each
capsule contains the following inactive ingredients: crospovidone,
lactose monohydrate,
magnesium stearate, talc and corn starch. The capsule shells and
imprinting inks
contain: titanium dioxide, gelatin, shellac glaze, black iron oxide,
n-butyl alcohol,
propylene glycol, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum
lake, D&C
Yellow #10 aluminum lake and FD&C Blue #1. The 2 mg capsule shell also
contains D&C
Red #33.
FDA approved dissolution test specifications differ from USP.
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 an