PRAZOSIN HYDROCHLORIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Aurobindo Pharma Limited

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Prazosin hydrochloride capsules 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 and

Toote kokkuvõte:

Prazosin Hydrochloride Capsules USP, 1 mg are yellow opaque cap and yellow opaque body, hard gelatin capsule shell imprinted “PRA” on cap and “1” on the body filled with white to off white granules.                  Bottles of 100                  NDC 59651-271-01                  Bottles of 1,000               NDC 59651-271-99 Prazosin Hydrochloride Capsules USP, 2 mg are yellow opaque cap and pink opaque body, hard gelatin capsule shell imprinted “PRA” on cap and “2” on the body filled with white to off white granules.                  Bottles of 100                  NDC 59651-272-01                  Bottles of 1,000               NDC 59651-272-99 Prazosin Hydrochloride Capsules USP, 5 mg are yellow opaque cap and blue opaque body, hard gelatin capsule shell imprinted “PRA” on cap and “5” on the body filled with white to off white granules.                  Bottles of 100                   NDC 59651-273-01                  Bottles of 250                   NDC 59651-273-25 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PRAZOSIN HYDROCHLORIDE - PRAZOSIN HYDROCHLORIDE CAPSULE
AUROBINDO PHARMA LIMITED
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PRAZOSIN HYDROCHLORIDE CAPSULES USP
_FOR ORAL USE_
RX ONLY
DESCRIPTION
Prazosin hydrochloride, 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 or almost white crystalline powder, very slightly
soluble in water, slightly
soluble in alcohol and methanol, practically insoluble in acetone and
has a molecular
weight of 419.87. Each 1 mg capsule of prazosin hydrochloride USP, for
oral use
contains drug equivalent to 1 mg free base.
Prazosin hydrochloride capsules USP contains the following inactive
ingredients: corn
starch, magnesium stearate, sodium lauryl sulfate, sucrose. The hard
gelatin capsules
contain gelatin and titanium dioxide. In addition, the 1 mg hard
gelatin capsules contain
D&C Yellow 10 and FD&C Yellow 6; the 2 mg hard gelatin capsules
contain D&C Yellow
10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6; the 5 mg hard gelatin
capsules
contains D&C Yellow 10, FD&C Blue 1, FD&C Red 3 and FD&C Yellow 6.
The capsule shells are imprinted with black ink which contains black
iron oxide,
potassium hydroxide 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
19
21
5
4
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 prazosi