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:

Aidarex Pharmaceuticals LLC

INN (International Name):

PRAZOSIN HYDROCHLORIDE

Composition:

PRAZOSIN 1 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 as follows: 1 mg: An ivory opaque capsule, filled with white powder, imprinted with "TEVA" on the cap and "4067" on the body, containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin, packaged in bottles of 30 and 60 capsules. 2 mg: A pink opaque capsule, filled with white powder, imprinted with "TEVA" on the cap and "4068" on the body, containing prazosin hydrochloride, USP equivalent to 2 mg of prazosin, packaged in bottles of 30 capsules. Dispense in a well-closed, light-resistant container as defined in the USP. Use child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
AIDAREX PHARMACEUTICALS LLC
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PRAZOSIN HYDROCHLORIDE CAPSULES USP
4067
4068
4069
RX ONLY
DESCRIPTION
Prazosin hydrochloride, 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:
C
H N O •HCl M.W. 419.87
It is a white, crystalline substance, slightly soluble in water and
isotonic saline.
Each capsule for oral administration, contains prazosin hydrochloride,
USP equivalent to 1 mg, 2 mg or
5 mg of prazosin. Inactive ingredients include: anhydrous lactose,
magnesium stearate, and
pregelatinized starch. Additional inactive ingredients for the gelatin
capsule include: 1 mg (Ivory): D&C
Yellow No. 10 and titanium dioxide; 2 mg (Pink): FD&C Blue No. 1, FD&C
Red No. 40, D&C Red No.
28, and titanium dioxide; 5 mg (Light Blue): FD&C Blue No. 1 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 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 clinically significant
change in cardiac output, heart r