PRAZOSIN HYDROCHLORIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Biocon Pharma Inc.

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Prazosin hydrochloride capsules is 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 and w

Toote kokkuvõte:

Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin.                  bottles of 100 capsules (NDC 70377-066-11)                                   bottles of 100 capsules (NDC 70377-067-11)                                     bottles of 100 capsules (NDC 70377-068-11)                    Store at 25o C (77o F); excursions permitted to 15 to 30o C (59 to 86o F) [See USP Controlled Room Temperature]. Protect from moisture and light.   Dispense in a well-closed, light-resistant container as defined by the USP using a child-resistant closure.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PRAZOSIN HYDROCHLORIDE - PRAZOSIN HYDROCHLORIDE CAPSULE
BIOCON PHARMA INC.
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_FOR ORAL USE_
DESCRIPTION
Prazosin hydrochloride capsules, 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 white or almost white crystalline powder, very slightly soluble
in water, slightly
soluble in methanol, in dimethylformamide, in dimethylacetamide and in
alcohol;
practically insoluble in chloroform and in acetone, and has a
molecular weight of 419.87.
Each capsule, for oral use, contains prazosin hydrochloride, USP
equivalent to 1 mg, 2
mg or 5 mg of prazosin.
Inert ingredients in the formulations are: colloidal silicon dioxide,
magnesium stearate,
sodium starch glycolate, sucrose. The empty hard gelatin capsule
shells contain gelatin
and titanium dioxide. In addition, the 2 mg and 5 mg empty hard
gelatin capsule shells
contains D&C Red 28, FD&C Blue 1, FD&C Red 3 and FD&C Red 40. The
Imprint ink
contains black iron oxide, potassium hydroxide, propylene glycol and
shellac.
FDA approved dissolution test specifications differ from USP.
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
19
21
5
4
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.
Tolerance has not been observed to develop in long termtherapy.
Hemodynamic studies have been ca