TERAZOSIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RedPharm Drug, Inc.

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 Capsules are available in four dosage strengths: 1 mg Terazosin Capsules, USP are available as gray opaque cap/body printed “TL 383” in black ink. Bottles of 90: NDC 59746-383-90 Bottles of 100: NDC 59746-383-06 Bottles of 500: NDC 59746-383-09 Bottles of 1000: NDC 59746-383-10 2 mg Terazosin Capsules, USP are available as ivory opaque cap/body printed “TL 384” in black ink. Bottles of 90: NDC 59746-384-90 Bottles of 100: NDC 59746-384-06 Bottles of 500: NDC 59746-384-09 Bottles of 1000: NDC 59746-384-10 5 mg Terazosin Capsules, USP are available as bright orange opaque cap/body printed “TL 385” in black ink. Bottles of 90: NDC 59746-385-90 Bottles of 100: NDC 59746-385-06 Bottles of 500: NDC 59746-385-09 Bottles of 1000: NDC 59746-385-10 10 mg Terazosin Capsules, USP are available as light green opaque cap/body printed “TL 386” in black ink. Bottles of 90: NDC 59746-386-90 Bottles of 100: NDC 59746-386-06 Bottles of 500: NDC 59746-386-09 Bottles of 1000: NDC 59746-386-10 Dispense in a tight, light-resistant container as defined in the USP. Recommended storage: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Rx only Revised 08/12 Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA For additional copies of the printed patient information/medication guide, please visit WWW.CADISTA.COM or call 1-800-313-4623.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERAZOSIN- TERAZOSIN CAPSULE
REDPHARM DRUG, INC.
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DESCRIPTION
Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking
agent, is a
quinazoline derivative represented by the following chemical
name,molecular formula and
structural formula:
(RS)-Piperazine,
1-(4-amino-6,7-dimethoxy-2-quinazolinyl)-4-[(tetrahydro-2-
furanyl)carbonyl]-, monohydrochloride.C19H26ClN5O4
[Terazosin Hydrochloride Chemical Structure]
Terazosin hydrochloride is a white, crystalline substance, freely
soluble in water and
isotonic saline and has a molecular weight of 423.93. Each capsule,
for oral
administration, contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as
terazosin
hydrochlolde. In addition, each capsule contains the following
inactive ingredients:
colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
and pregelatinized
starch. The gelatin capsule contains gelatin, silicon dioxide, sodium
lauryl sulfate, and
titanium dioxide. The 1 mg shell also contains black iron oxide; the 2
mg capsule shell
also contains D&C Yellow #10; the 5 mg capsule shell also contains D&C
Yellow #10,
FD&C Red #40 and D&C Red #28; the 10 mg capsule shell also contains
FD&C Green
#3 and D&C Yellow#10.
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 and bladd