PRAZOSIN HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Major Pharmaceuticals

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Prazosin Hydrochloride Capsules, USP 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

Περίληψη προϊόντος:

Prazosin Hydrochloride Capsules, USP 1 mg for oral administration containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin, are supplied as follows: Hard gelatin capsule shell with dark green colored cap and light brown colored body, imprinted with white ink as 019 on cap and novitium on body, filled with white to off-white powder blend. Available in cartons of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7020-61 Prazosin Hydrochloride Capsules, USP 2 mg for oral administration containing prazosin hydrochloride, USP equivalent to 2 mg of prazosin, are supplied as follows: Hard gelatin capsule shell with brown colored cap and light brown colored body, imprinted with white ink as 020 on cap and novitium on body, filled with white to off-white powder blend. Available in cartons of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7021-61 Prazosin Hydrochloride Capsules, USP 5 mg for oral administration containing prazosin hydrochloride, USP equivalent to 5 mg of prazosin, are supplied as follows: Hard gelatin capsule shell with light blue colored cap and light brown colored body, imprinted with white ink as 021 on cap and novitium on body, filled with white to off-white powder blend. Available in cartons of 100 capsules (10 capsules per blister pack x 10), NDC 0904-7022-61 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and light. Dispense in a tight, light-resistant container as defined in the USP.  Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Distributed by: MAJOR® PHARMACEUTICALS Livonia, MI 48152 USA Refer to package label for Distributor's NDC Number Issued: 08/2021 LB4375-00 REFERENCES 1) Lubbe, WF, and Hodge, JV: New Zealand Med J, 94 (691) 169-172,1981.  2) Davey, DA, and Dommisse, J: SA. Med J, Oct.4, 1980 (551-556).

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
MAJOR PHARMACEUTICALS
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PRAZOSIN HYDROCHLORIDE CAPSULES, USP 1 MG, 2 MG AND 5 MG
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 water, practically
insoluble in chloroform and acetone and has a
molecular weight of 419.87. 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, lactose anhydrous,
magnesium stearate and microcrystalline cellulose. The empty hard
gelatin capsules contain black iron oxide,
gelatin, red iron oxide, titanium dioxide and yellow iron oxide. In
addition, the 1 mg empty gelatin capsules
contain D&C Yellow No. 10 and FD&C Green No. 3; the 2 mg empty gelatin
capsules contain D&C Red No. 28,
D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40; and the 5 mg
empty gelatin capsules contain FD&C
Blue No. 1.
The capsules shells are imprinted in edible ink which contains
concentrated ammonium solution, potassium
hydroxide, propylene glycol, shellac and titanium dioxide.
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 antihypertens