SECTRAL- acebutolol hydrochloride capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

ACEBUTOLOL HYDROCHLORIDE (UNII: B025Y34C54) (ACEBUTOLOL - UNII:67P356D8GH)

Доступна с:

Promius Pharma, LLC

ИНН (Международная Имя):

ACEBUTOLOL HYDROCHLORIDE

состав:

ACEBUTOLOL 200 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Sectral is indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Sectral is indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats. Sectral is contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See WARNINGS .) Safety and effectiveness in pediatric patients have not been established. Clinical studies of Sectral and other reported clinical experience is inadequate to determine whether there are differences in safety or effectiveness between patients above or below age 65. Elderly subjects evidence greater bioavailability of acebutolol (see CLINICAL PHARMACOLOGY—Pharmac

Обзор продуктов:

Sectral® (acebutolol HCl) is available in the following dosage strengths: 200 mg, opaque purple and orange capsule marked "RP 700" and "Sectral® 200" NDC 67857-700-01, in bottles of 100 capsules. 400 mg, opaque brown and orange capsule marked "RP 701" and "Sectral® 400" NDC 67857-701-01, in bottles of 100 capsules. Keep tightly closed Store at controlled room temperature 20° to 25°C (68° to 77°F) Protect from light Dispense in a light-resistant, tight container Use carton to protect contents from light Distributed by: Promius Pharma, LLC Bridgewater, NJ 08807 Manufactured by: PATHEON, Puerto Rico, Inc. Manatí, Puerto Rico 00674, USA Revised April 2008

Статус Авторизация:

New Drug Application

Характеристики продукта

SECTRAL - ACEBUTOLOL HYDROCHLORIDE CAPSULE
PROMIUS PHARMA, LLC
----------
DESCRIPTION
Sectral (acebutolol HCl) is a selective, hydrophilic
beta-adrenoreceptor blocking agent with mild
intrinsic sympathomimetic activity for use in treating patients with
hypertension and ventricular
arrhythmias. It is marketed in capsule form for oral administration.
Sectral capsules are provided in two
dosage strengths which contain 200 or 400 mg of acebutolol as the
hydrochloride salt. The inactive
ingredients present are D&C Red 22, FD&C Blue 1, FD&C Yellow 6,
gelatin, povidone, starch, stearic
acid, and titanium dioxide. The 200 mg dosage strength also contains
D&C Red 28 and the 400 mg
dosage strength also contains FD&C Red 40.
Acebutolol HCl has the following structural formula:
Acebutolol HCl is a white or slightly off-white powder freely soluble
in water, and less soluble in
alcohol. Chemically it is defined as the hydrochloride salt of
(±)N-[3-Acetyl-4-[2- hydroxy-3-[(1-
methylethyl)amino]propoxy]phenyl] butanamide.
CLINICAL PHARMACOLOGY
Sectral is a cardioselective, β-adrenoreceptor blocking agent, which
possesses mild intrinsic
sympathomimetic activity (ISA) in its therapeutically effective dose
range.
PHARMACODYNAMICS
β -cardioselectivity has been demonstrated in experimental animal
studies. In anesthetized dogs and cats,
Sectral is more potent in antagonizing isoproterenol-induced
tachycardia (β ) than in antagonizing
isoproterenol-induced vasodilatation (β ).In guinea pigs and cats, it
is more potent in antagonizing this
tachycardia than in antagonizing isoproterenol- induced
bronchodilatation (β ). ISA of Sectral has been
demonstrated in catecholamine-depleted rats by tachycardia induced by
intravenous administration of
this agent. A membrane-stabilizing effect has been detected in
animals, but only with high concentrations
of Sectral.
Clinical studies have demonstrated β -blocking activity at the
recommended doses by: a) reduction in the
resting heart rate and decrease in exercise-induced tachycardia; b)
redu