PRAZOSIN HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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. NDC 68788-7849-3             Bottles of 30 capsules NDC 68788-7849-6             Bottles of 60 capsules NDC 68788-7849-9             Bottles of 90 capsules NDC 68788-7849-1             Bottles of 100 capsules 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 Repackaged By: Preferred Pharmaceuticals Inc. 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). Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
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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
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-blocker