TERAZOSIN- terazosin hydrochloride capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

REMEDYREPACK 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 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.

Resumen del producto:

Terazosin Capsules are available in four dosage strengths: 2 mg Terazosin Capsules, USP are available as Size 3 ivory opaque capsules printed "TL 384" axially in black ink on body and cap. NDC: 70518-1875-00 PACKAGING: 30 in 1 BLISTER PACK Repackaged and Distributed By : Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 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 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

TERAZOSIN- TERAZOSIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
----------
TERAZOSIN CAPSULES, USP
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
B. Hypertension
In animals, terazosin causes a decrease in blood pressure by
decreasing total peripheral
vascular resistance. The vasodilatory hypotensive action of terazosin
appears to be
produced mainly by blockade of alpha-1 adrenoceptors. Terazosin
decreases blood
pressure gradually within 15 minutes following oral administration.
Patients in clinical trials of terazosin were administered once daily
(the great majority)
and twice daily regimens with total doses usually in the range of 5 to
20 mg/day, and
had mild (about 77%, diastolic pressure 95 to 105 mmHg) or moderate
(23%, diastolic
pressure 105 to 115 mmHg) hypertension. Because terazosin, like all
alpha antagonists,
can cause unusually large falls in blood pressure after the first dose
or first few doses,
the initial dose was 1 mg in virtually all trials, with subsequent
titration to a specified fixed
dose or titration to some specified blood pressure end point (usually
a supine diastolic
pressure of 90 mmHg).
Blood pressure responses were measured at the end of the dosing
interval (usually 24
hours) and effects were shown to persist throughout the interval, with
the usual supine
responses 5 to 10 mmHg systolic and 3.5 to 8 mmHg diastolic greater
than placebo.
The responses in the standing position tended to be somewhat larger,
by 1 to 3 mmHg,
although this was not true in all studies. The magnitude of the blood
pressure responses
was similar to prazosin and less than hydrochlorothiazide (in a single
study of
hypertensive patients). In measurements 24 hours after dosing, heart
rate was
unchanged.
Limited measurements of peak response (2 to 3 hours after dosing)
during chronic
terazosin administration indicate that it is greater than about twice
the trough (24 hour)
response, suggesting some attenuation of response at 24 hours,
presumably due to a
fall in blood terazosin concentrations at the end of the dose
interval. Thi