Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
PRAZOSIN HYDROCHLORIDE (UNII: X0Z7454B90) (PRAZOSIN - UNII:XM03YJ541D)
ANI Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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
Prazosin Hydrochloride Capsules USP are available as follows: 1 mg* hard gelatin capsules consisting of an opaque white body imprinted “580” in black ink and an opaque white cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-580-01) and 1000 capsules (62559-580-10). 2 mg* hard gelatin capsules consisting of an opaque white body imprinted “581” in black ink and an opaque pink cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-581-01) and 1000 capsules (62559-581-10). 5 mg* hard gelatin capsules consisting of an opaque white body imprinted “582” in black ink and an opaque blue cap imprinted “ANI” in black ink supplied in bottles of 100 capsules (NDC 62559-582-01) and 250 capsules (62559-582-25). *Equivalent to prazosin. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture and light.
Abbreviated New Drug Application
PRAZOSIN HYDROCHLORIDE- PRAZOSIN HYDROCHLORIDE CAPSULE ANI PHARMACEUTICALS, INC. ---------- PRAZOSIN HYDROCHLORIDE CAPSULES USP _FOR ORAL USE_ 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- dimethoxy2-quinazolinyl)-4-(2-furoyl) piperazine and its structural formula is: Molecular formula C H N O ·HCl It is a white, crystalline substance, slightly soluble in water and isotonic saline, and has a molecular weight of 419.87. Each capsule for oral use contains prazosin hydrochloride equivalent to 1 mg, 2 mg or 5 mg of prazosin. Inert ingredients in the formulations are: lactose monohydrate, polysorbate 80, hypromellose, corn starch, magnesium stearate, titanium dioxide, sodium laurel sulfate, gelatin, shellac, propylene glycol, ammonia, potassium hydroxide, and black iron oxide. In addition, the 2 mg capsules contain FD&C Blue 1 and FD&C Red 3; and the 5 mg capsules contain FD&C Blue 1. 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 clinical Lestu allt skjalið