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:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Prazosin Hydrochloride Capsules USP 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

Product summary:

Prazosin Hydrochloride Capsules USP are available as follows: 1 mg* hard gelatin capsules consisting of an opaque white body imprinted “580” in black ink and an opaque white cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-580-01) and 1000 capsules (62559-580-10). 2 mg* hard gelatin capsules consisting of an opaque white body imprinted “581” in black ink and an opaque pink cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-581-01) and 1000 capsules (62559-581-10). 5 mg* hard gelatin capsules consisting of an opaque white body imprinted “582” in black ink and an opaque blue cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-582-01) and 250 capsules (62559-582-25). *Equivalent to prazosin. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
ANI PHARMACEUTICALS, INC.
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PRAZOSIN HYDROCHLORIDE CAPSULES USP
_FOR ORAL USE_
DESCRIPTION
Prazosin Hydrochloride Capsules 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-
dimethoxy2-quinazolinyl)-4-(2-furoyl) piperazine and its structural
formula is:
Molecular formula C
H
N O ·HCl
It is a white, crystalline substance, slightly soluble in water and
isotonic saline, and has a
molecular weight of 419.87. Each capsule for oral use contains
prazosin hydrochloride
equivalent to 1 mg, 2 mg or 5 mg of prazosin.
Inert ingredients in the formulations are: lactose monohydrate,
polysorbate 80,
hypromellose, corn starch, magnesium stearate, titanium dioxide,
sodium laurel sulfate,
gelatin, shellac, propylene glycol, ammonia, potassium hydroxide, and
black iron oxide.
In addition, the 2 mg capsules contain FD&C Blue 1 and FD&C Red 3; and
the 5 mg
capsules contain FD&C Blue 1.
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
antihypertensive action of prazosin is usually not accompanied by a
reflex tachycardia.
Tolerance has not been observed to develop in long term therapy.
Hemodynamic studies have been carried out in man following acute
single dose
administration and during the course of long term maintenance therapy.
The results
confirm that the therapeutic effect is a fall in blood pressure
unaccompanied by a
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