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:

ANI Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acebutolol Hydrochloride Capsules USP 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. Acebutolol Hydrochloride Capsules USP 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 hydrochloride capsules are contraindicated in: 1) persistently severe bradycardia; 2) second- and third-degree heart block; 3) overt cardiac failure; and 4) cardiogenic shock. (See WARNINGS .)

Product summary:

Acebutolol Hydrochloride Capsules USP are available in the following dosage strengths: 200 mg (acebutolol hydrochloride equivalent to 200 mg of acebutolol): hard gelatin capsule with a gray opaque body and red opaque cap imprinted with “ANI 255” in black ink. NDC 62559-255-01       Bottles of 100 capsules. 400 mg (acebutolol hydrochloride equivalent to 400 mg of acebutolol): hard gelatin capsule with a green opaque body and maroon opaque cap imprinted with “ANI 256” in white ink. NDC 62559-256-01       Bottles of 100 capsules. Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 08/2022 LB4527-00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACEBUTOLOL HYDROCHLORIDE- ACEBUTOLOL HYDROCHLORIDE CAPSULE
ANI PHARMACEUTICALS, INC.
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ACEBUTOLOL HYDROCHLORIDE CAPSULES USP
DESCRIPTION
Acebutolol hydrochloride USP 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 Hydrochloride Capsules USP are provided in
two dosage
strengths which contain 200 mg or 400 mg of acebutolol as the
hydrochloride salt. The
inactive ingredients are povidone, corn starch, pregelatinized starch,
and stearic acid.
The capsule shells and imprinting ink for the 200 mg dosage strength
also contain FD&C
Blue 1, FD&C Red 40, titanium dioxide, black iron oxide, yellow iron
oxide, sodium lauryl
sulfate, gelatin, carboxymethylcellulose, shellac, ammonium hydroxide,
propylene glycol,
and potassium hydroxide. The capsule shells and imprinting ink for the
400 mg dosage
strength also contain FD&C Blue 1, FD&C Red 3, titanium dioxide, FD&C
Yellow 6, D&C
Yellow 10, sodium lauryl sulfate, gelatin, shellac, ammonium
hydroxide, propylene glycol,
simethicone, and sodium hydroxide.
Acebutolol hydrochloride USP has the following structural formula:
C
H
N O •HCl M.W. 372.9
Acebutolol hydrochloride USP 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
18
28
2
4
anesthetized dogs and cats, acebutolol is more potent in antagonizing
isoproterenol-
induced tachycardia (β1) than in antagonizing isoproterenol-induced
vasodilatation (β2).
In g