PRAZOSIN HYDROCHLORIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Alembic Pharmaceuticals 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 are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is opaque white cap/opaque white body hard gelatin capsules size “4” having imprinting “A” on cap with black ink and “320” on body with black ink filled with white to off white granular powder. They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 46708-691-31 Bottle of 250 capsules, NDC 46708-691-61 Bottle of 1000 capsules, NDC 46708-691-91 The 2 mg capsule is opaque pink cap/opaque white body hard gelatin capsules size “2” having imprinting “A” on cap with black ink and “321” on body with black ink filled with white to off white granular powder. They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 46708-692-31 Bottle of 250 capsules, NDC 46708-692-61 Bottle of 1000 capsules, NDC 46708-692-91 The 5 mg capsule is opaque blue cap/opaque white body hard gelatin capsules size “0” having imprinting “A” on cap with black ink and “322” on body with black ink filled with white to off white granular powder. They are available as follows: Bottle of 100 capsules with child-resistant closure, NDC 46708-693-31 Bottle of 250 capsules, NDC 46708-693-61 Bottle of 1000 capsules, NDC 46708-693-91 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant containers (USP). 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: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India      Revised: 11/2022

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

PRAZOSIN HYDROCHLORIDE - PRAZOSIN HYDROCHLORIDE CAPSULE
ALEMBIC PHARMACEUTICALS LIMITED
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PRAZOSIN HYDROCHLORIDE CAPSULES, USP
_FOR ORAL USE_
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 to tan powder, slightly soluble in methanol, in dimethyl
formamide, in
dimethyl acetamide, very slightly soluble in alcohol, practically
insoluble in chloroform and
in acetone. It 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.
Inert ingredients in the formulations are: sucrose, corn starch,
sodium lauryl sulfate,
microcrystalline cellulose, colloidal silicon dioxide and magnesium
stearate. The empty
hard gelatin capsule shell contains gelatin and titanium dioxide. In
addition, the 2 mg and
5 mg empty hard gelatin capsule shell also contain FD&C Blue 1 and
FD&C Red 3. The
empty hard gelatin capsule shells are imprinted with edible black ink
containing shellac,
potassium hydroxide and black iron oxide.
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
19
21
5
4•
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.
Tolerance has