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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

PRAZOSIN HYDROCHLORIDE

Composition:

PRAZOSIN 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 2 mg of prazosin. The 2 mg capsules are hard-shell gelatin capsules with a brown opaque cap and a light brown opaque body filled with a white to off-white powder blend. The capsule is axially printed with MYLAN over 2302 in white ink on both the cap and body. They are available as follows: NDC 43063-260-30 bottles of 30 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 by the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
PD-RX PHARMACEUTICALS, INC.
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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-
dimethoxy-2-quinazolinyl)-4-(2-furoyl) piperazine and its structural
formula is:
It is a white to tan powder, slightly soluble in water and methanol,
very slightly soluble in
alcohol, practically insoluble in chloroform and acetone and has a
molecular weight of
419.87. Each capsule, for oral use, 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 and microcrystalline cellulose. The empty 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 imprinting ink also contains ammonium hydroxide, propylene glycol,
shellac glaze,
simethicone 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
antihypertensive action of prazosin is usually not accompanied by a
reflex tachycardia.
Tolerance has not been observed