PRAZOSIN HYDROCHLORIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Lifestar Pharma LLC

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 are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is White opaque cap/ white opaque body, hard gelatin capsule imprinted with on cap and "429" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-429-11  bottles of 100 capsules. This package is child resistant  NDC 70756-429-12  bottles of 1000 capsules. This package is not child resistant  The 2 mg capsule is Pink opaque cap/ Pink opaque body, hard gelatin capsule imprinted with on cap and "430" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-430-11  bottles of 100 capsules. This package is child resistant NDC 70756-430-12  bottles of 1000 capsules. This package is not child resistant  The 5 mg capsule is Blue opaque cap/ Blue opaque body, hard gelatin capsule imprinted with  on cap and "440" on body with black ink containing white to off white powder. They are available as follows: NDC 70756-440-11  bottles of 100 capsules. This package is child resistant NDC 70756-440-12  bottles of 1000 capsules. This package is not child resistant  Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP Keep this and all medication out of the reach of children.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PRAZOSIN HYDROCHLORIDE - PRAZOSIN HYDROCHLORIDE CAPSULE
LIFESTAR PHARMA LLC
----------
PRAZOSIN HYDROCHLORIDE CAPSULES, USP
_FOR ORAL USE_
RX ONLY
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 white to tan powder, slightly soluble in water, in methanol, in
dimethyl formamide, in
dimethyl acetamide, very slightly soluble in alcohol, practically
insoluble in isotonic saline,
in chloroform and in acetone and has a molecular weight of 419.86.
Each capsule, for
oral administration, contains prazosin hydrochloride, USP equivalent
(as the polyhydrate)
to 1 mg, 2 mg or 5 mg of prazosin.
Inert ingredients in the formulations are: colloidal silicon dioxide,
lactose monohydrate,
magnesium stearate, microcrystalline cellulose and sodium lauryl
sulfate. The hard
gelatin capsules contain gelatin and titanium dioxide. In addition,
the 2 mg empty gelatin
capsules contain FD&C Red No. 40, FD&C Red No. 3 and FD&C Blue No. 1;
and the 5 mg
empty gelatin capsules contain FD&C Red 3 and FD&C Blue No. 1.
The imprinting ink also contains Black Iron Oxide, Potassium
Hydroxide, Shellac.
FDA approved dissolution test specifications differ from USP.
CLINICAL PHARMACOLOGY
The exact mechanism of the hypotensive action of prazosin is unknown.
Prazosin
19
21
5
4•
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