PRAZOSIN HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 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, USP 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.

Περίληψη προϊόντος:

Prazosin Hydrochloride Capsules, USP 1 mg for oral administration containing prazosin hydrochloride, USP equivalent to 1 mg of prazosin, are supplied as follows: Hard gelatin capsule shell with dark green colored cap and light brown colored body, imprinted with white ink as 019 on cap and novitium on body, filled with white to off-white powder blend. NDC: 70518-2177-00 NDC: 70518-2177-01 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
----------
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
19
21
5
4
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
antihy