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:

Preferred Pharmaceuticals Inc.

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Prazosin hydrochloride capsules USP 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

Περίληψη προϊόντος:

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 (NDC 68788-7335-3) Bottles of 60 (NDC 68788-7335-6) Bottles of 90 (NDC 68788-7335-9) Bottles of 100 (NDC 68788-7335-1) 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
PRAZOSIN HYDROCHLORIDE CAPSULES USP
4067
4068
4069
RX ONLY
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:
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
19
21
5
4
clinically significant change in cardi