TERAZOSIN HYDROCHLORIDE ANHYDROUS- terazosin hydrochloride anhydrous capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERAZOSIN HYDROCHLORIDE ANHYDROUS (UNII: 8QOP8Z9955) (TERAZOSIN - UNII:8L5014XET7)

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

TERAZOSIN HYDROCHLORIDE ANHYDROUS

Composition:

TERAZOSIN 2 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. 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.

Product summary:

Terazosin Capsules, USP are available containing 2 mg of terazosin as terazosin hydrochloride, USP anhydrous. The 2 mg capsule is a hard-shell gelatin with a black opaque cap and a light lavender opaque body filled with white to off-white powder. The capsule is axially imprinted with MYLAN over 2264 in white ink on both the cap and body. They are available as follows: NDC 43063-495-30 bottles of 30 capsules Store at 20° to 25°C (68° to 77°F). [See USP 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERAZOSIN HYDROCHLORIDE ANHYDROUS- TERAZOSIN HYDROCHLORIDE ANHYDROUS
CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
DESCRIPTION
Terazosin hydrochloride, an alpha-1-selective adrenoceptor blocking
agent, is a quinazoline derivative
represented by the following chemical name and structural formula:
1-(4-Amino-6,7-dimethoxy-2-
quinazolinyl)-4-(tetrahydro-2-furoyl)piperazine monohydrochloride
dehydrate.
Terazosin hydrochloride, USP is a white to pale yellow, crystalline
powder, freely soluble in water
and isotonic saline and has a molecular weight of 423.9. Each
terazosin capsule, for oral administration,
contains 1 mg, 2 mg, 5 mg or 10 mg of terazosin as terazosin
hydrochloride, USP anhydrous. Each
capsule contains the following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide, D&C
Red No. 28, D&C Red No. 33, FD&C Blue No. 1, gelatin, magnesium
stearate, microcrystalline
cellulose, pregelatinized starch (corn), sodium lauryl sulfate and
titanium dioxide. In addition, the 1 mg
capsule contains yellow iron oxide; the 2 mg and 5 mg capsules contain
black iron oxide. The black
imprinting ink for the 1 mg, 5 mg and 10 mg capsules contains the
following: black iron oxide, D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue
No. 2 Aluminum Lake,
FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. The
white imprinting ink for
the 2 mg capsules contains the following ammonium hydroxide, propylene
glycol, shellac glaze,
simethicone and titanium dioxide.
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