TERAZOSIN capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Blenheim Pharmacal, Inc.

INN (mednarodno ime):

TERAZOSIN HYDROCHLORIDE

Sestava:

TERAZOSIN 10 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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. It 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.

Povzetek izdelek:

Terazosin Capsules, USP are available for oral administration as 1 mg, 2 mg, 5 mg and 10 mg capsules. Terazosin Capsules, USP 1 mg: Hard gelatin capsules with a beige opaque body and a beige opaque cap. “APO 115” is imprinted on each capsule in black ink; supplied in bottles of 100 (NDC 60505-0115-0), bottles of 500 (NDC 60505-0115-5) and bottles of 1000 (NDC 60505-0115-1).  Terazosin Capsules, USP 2 mg: Hard gelatin capsules with a yellow opaque body and a yellow opaque cap. “APO 116” is imprinted on each capsule in black ink; supplied in bottles of 100 (NDC 60505-0116-0), bottles of 500 (NDC 60505-0116-5), bottles of 1000 (NDC 60505-0116-1) and bottles of 7,000 (NDC 60505-0116-7). Terazosin Capsules, USP 5 mg: Hard gelatin capsules with a red opaque body and a red opaque cap. “APO 117” is imprinted on each capsule in black ink; supplied in bottles of 100 (NDC 60505-0117-0), bottles of 500 (NDC 60505-0117-5), bottles of 1000 (NDC 60505-0117-1) and bottles of 7,000 (NDC 60505-0117-7). Terazosin Capsules, USP 10 mg: Hard gelatin capsules with a blue opaque body and a blue opaque cap. “APO 118” is imprinted on each capsule in black ink; supplied in bottles of 100 (NDC 60505-0118-0), bottles of 500 (NDC 60505-0118-5) and bottles of 1000 (NDC 60505-0118-1). Recommended storage: Store at 20º to 25°C (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. APOTEX INC. TERAZOSIN CAPSULES, USP 1 MG, 2 MG, 5 MG AND 10 MG Revised: June 2011 Revision 2

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

TERAZOSIN- TERAZOSIN CAPSULE
BLENHEIM PHARMACAL, INC.
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TERAZOSIN CAPSULES, 1MG, 2MG, 5MG AND 10 MG
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-l adrenoceptors, which are abundant in
the prostate, prostatic capsule and
bladder neck. The reduction in symptoms and improvement in urine flow
rates following administration
of terazosin is related to relaxation of smooth muscle produced by
blockade of alpha-l adrenoceptors in
the bladder neck and prostate. Because there are relatively few
alpha-l adrenoceptors in the bladder
body, terazosin is able to reduce the bladder outlet obstruction
without affecting bladder contractility.
Terazosin has been studied in 1222 men with symptomatic BPH. In three
placebo-controlled studies,
symptom evaluation and uroflowmetric measurements were performed
approximately 24 hours
following dosing. Symptoms were quantified using the Boyarsky Index.
The questionnaire evaluated
both obstructive (hesitancy, intermittency, terminal dribbling,
impairment of size and force of stream,
sensation of incomplete bladder emptying) and irritative (nocturia,
daytime frequency, urgency, dysuria)
symptoms by rating each of the 9 symptoms from 0-3, for a total score
of 27 points. Results from these
studies indicated that terazosin statistically significantly improved
symptoms and peak urine