ACEBUTOLOL HYDROCHLORIDE- acebutolol hydrochloride capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

AvKARE, Inc.

INN (Algemene Internationale Benaming):

ACEBUTOLOL HYDROCHLORIDE

Samenstelling:

ACEBUTOLOL 200 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

HYPERTENSION: Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. VENTRICULAR ARRHYTHMIAS: Acebutolol hydrochloride capsules are 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. Acebutolol HCl is contraindicated in: 1) persistently severe bradycardia; 2) second-and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See Warnings.)

Product samenvatting:

Acebutolol hydrochloride capsules are available as follows: 200 mg: Size "2" hard gelatin capsules with bright orange opaque body printed radially "669" with black ink and lavender opaque cap printed radially "Amneal" with black ink. NDC 42291-101-90 Bottles of 90 400 mg: Size "2" hard gelatin capsules with bright orange opaque body printed radially "670" with black ink and lavender opaque cap printed radially "Amneal" with black ink. NDC 42291-102-90 Bottles of 90 Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Keep tightly closed. Dispense in a light resistant, tight container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ACEBUTOLOL HYDROCHLORIDE- ACEBUTOLOL HYDROCHLORIDE CAPSULE
AVKARE, INC.
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ACEBUTOLOL HYDROCHLORIDE CAPSULES
DESCRIPTION
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. Acebutolol HCl
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 28, D&C Yellow 10, FD&C Blue 1, FD&C
Red 40, gelatin, maize
starch, povidone, titanium dioxide and stearic acid.
Acebutolol HCl has the following structural formula:
C
H
N
O
•HCl M.W. 372.89
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
Acebutolol 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, acebutolol is more potent in antagonizing isoproterenol-induced
tachycardia (β
) than in
antagonizing isoproterenolinduced vasodilatation (β
). In guinea pigs and cats, it is more potent in
antagonizing this tachycardia than in antagonizing
isoproterenol-induced bronchodilatation (β
). ISA of
acebutolol 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 acebutolol.
Clinical studies have demonstrated β
-blocking activity at the recommended doses by: a) reduction in
the resting heart rate and decrease in exerciseinduced tachycardia; b)
reduction in car