ACEBUTOLOL HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

ACEBUTOLOL HYDROCHLORIDE

Composition:

ACEBUTOLOL 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hear t block; 3) over t cardiac failure; and 4) cardiogenic shock. (See Warnings.)

Product summary:

Acebutolol hydrochloride capsules are available as follows: 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. Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from light. Keep tightly closed. Dispense in a light resistant, tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACEBUTOLOL HYDROCHLORIDE - ACEBUTOLOL HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, 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_
β1-cardioselectivity has been demonstrated in experimental animal
studies. In anesthetized dogs and cats,
acebutolol is more potent in antagonizing isoproterenol-induced
tachycardia (β1) than in antagonizing
isoproterenolinduced vasodilatation (β2). In guinea pigs and cats, it
is more potent in antagonizing this
tachycardia than in antagonizing isoproterenol-induced
bronchodilatation (β2). 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 β1-blocking activity at the
recommended doses by: a) reduction in
the resting heart rate and decrease in exerciseinduced tachycardia; b)