PRAZOSIN- 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:

REMEDYREPACK INC.

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 with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Prazosin hydrochloride capsules can be used alone or in combination with other antihypertensive drugs such as diuretics or beta-adrenergic blocking agents. Prazosin hydrochloride capsules are contraindicated in patients with known sensitivity to quinazolines, prazosin, or any of the inert ingredients.

Product summary:

Prazosin hydrochloride 5 mg Blue and White capsule code: 438 NDC: 70518-1884-00 NDC: 70518-1884-01 NDC: 70518-1884-02 NDC: 70518-1884-03 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

PRAZOSIN- PRAZOSIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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PRAZOSIN HYDROCHLORIDE
CAPSULES
_FOR ORAL USE_
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:
It is a white, crystalline substance, slightly soluble in water and
isotonic saline, and has a
molecular weight of 419.87. Each 1 mg capsule of prazosin
hydrochloride for oral use
contains drug equivalent to 1 mg free base.
Inert ingredients in the formulations are: hard gelatin capsules
(which may contain Blue
1, Red 3, Red 28, Red 40, and other inert ingredients); magnesium
stearate; sodium
lauryl sulfate; starch; sucrose.
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 rate, renal
blood flow and glomerular
filtration rate. There is no measurable negative chronotropic effect.
In clinical studies to date, prazosin hydrochloride has not increased
plasma renin activ