PRAZOSIN HYDROCHLORIDE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Contract Pharmacy Services-PA

Designació comuna internacional (DCI):

PRAZOSIN HYDROCHLORIDE

Composición:

PRAZOSIN 1 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Prazosin Hydrochloride Capsules, USP are available containing prazosin hydrochloride, USP equivalent to 1 mg, 2 mg, or 5 mg of prazosin. The 1 mg capsule is a hard-shell gelatin capsule with a dark green 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 1101 in white ink on both the cap and body. They are available as follows: NDC 67046-209-07 blisterpacks of 7 NDC 67046-209-14 blisterpacks of 14 NDC 67046-209-15 blisterpacks of 15 NDC 67046-209-20 blisterpacks of 20 NDC 67046-209-21 blisterpacks of 21 NDC 67046-209-28 blisterpacks of 28 NDC 67046-209-30 blisterpacks of 30 NDC 67046-209-60 blisterpacks of 60 The 2 mg capsule is a hard-shell gelatin capsule 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 67046-208-07 blisterpacks of 7 NDC 67046-208-14 blisterpacks of 14 NDC 67046-208-15 blisterpacks of 15 NDC 67046-208-20 blisterpacks of 20 NDC 67046-208-21 blisterpacks of 21 NDC 67046-208-28 blisterpacks of 28 NDC 67046-208-30 blisterpacks of 30 NDC 67046-208-60 blisterpacks of 60 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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
CONTRACT PHARMACY SERVICES-PA
----------
208 PRAZOSIN 2 MG
209 PRAZOSIN 1 MG
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:
Molecular formula is C
H
N
O
• HCl
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 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, 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
pr