PRAZOSIN HYDROCHLORIDE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

PRAZOSIN HYDROCHLORIDE (UNII: X0Z7454B90) (PRAZOSIN - UNII:XM03YJ541D)

זמין מ:

Granules Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Prazosin hydrochloride capsules, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes

leaflet_short:

Prazosin hydrochloride capsules, USP are available as follows: 1 mg Hard gelatin capsules, white opaque cap printed with "GPI (over) 1 mg" and white opaque body printed with "084" contains white to off-white blend.  Bottles of 100     70010-084-01  Bottles of 1000    70010-084-10 2 mg Hard gelatin capsules, pink opaque cap printed with "GPI (over) 2 mg" and white opaque body printed with "085" contains white to off-white blend.   Bottles of 100         70010-085-01 Bottles of 1000       70010-085-10 5 mg Hard gelatin capsules, dark blue opaque cap printed with "GPI (over) 5 mg" and white opaque body printed with "086" contains white to off-white blend. Bottles of 100          70010-086-01 Bottles of 250          70010-086-25 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 with a child-resistant closure. References 1. Lubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169–172, 1981. 2.Davey, DA, and Dommisse, J: S.A. Med J , Oct. 4, 1980 (551–556). Manufactured by: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Rev. 10/2020   

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
GRANULES PHARMACEUTICALS INC.
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PRAZOSIN HYDROCHLORIDE CAPSULES, USP.
DESCRIPTION
Prazosin hydrochloride, USP a quinazoline-derivative, is the first of
a new chemical class
of antihypertensives. It is the hydrochloride salt of
1-(4-amino-6,7-dimethoxy-2-
quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is:
Molecular formula C
H
N
O
.HCl
It is a white, crystalline substance, very slightly soluble in water,
slightly soluble in
methanol, dimethylformamide, dimethylacetamide and alcohol,
practically insoluble in
chloroform and acetone, and has a molecular weight of 419.87. Each
capsule for oral
administration contains prazosin hydrochloride, USP equivalent to 1
mg, 2 mg or 5 mg
of prazosin.
Inactive ingredients in the formulations are: anhydrous lactose,
lactose monohydrate,
magnesium stearate and silicified microcrystalline cellulose. The
empty gelatin capsules
contain gelatin and titanium dioxide; the 2 mg capsules contain FD&C
red # 3 and FD&C
blue # 1 and the 5 mg capsules contain FD&C Red # 40 and FD&C Blue #
1. In addition,
capsule imprinting ink contains ammonium hydroxide, black iron oxide,
propylene glycol
and shellac glaze.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
The exact mechanism of the hypotensive action of prazosin is unknown.
Prazosin
causes a decrease in total peripheral resistance and was originally
thought to have a
direct relaxant action on vascular smooth muscle. Recent animal
studies, however, have
suggested that the vasodilator effect of prazosin is also related to
blockade of
postsynaptic alpha-adrenoceptors. The results of dog forelimb
experiments
demonstrate that the peripheral vasodilator effect of prazosin is
confined mainly to the
level of the resistance vessels (arterioles). Unlike conventional
alpha-blockers, the
antihypertensive action of prazosin is usually not accompanied by a
reflex tachycardia.
19
21
5
4
Tolerance has not been observed to develop in long term therapy.
Hemodynamic studies hav