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:

Marlex Pharmaceuticals Inc

INN (International Name):

ACEBUTOLOL HYDROCHLORIDE

Composition:

ACEBUTOLOL 200 mg

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 HCl, USP 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 summary:

Acebutolol hydrochloride capsules, USP are available as follows: 200 mg: Hard gelatin capsules with bright orange opaque body printed radially “669” with black ink and lavender opaque cap printed radially “Amneal” with black ink. Bottles of 100       NDC 10135-0630-01 400 mg: Hard gelatin capsules with bright orange opaque body printed radially “670” with black ink and lavender opaque cap printed radially “Amneal” with black ink. Bottles of 100       NDC 10135-0631-01 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. Manufactured for and Distributed by: Marlex Pharmaceuticals New Castle, DE 19720 Rev. 10/2017AN

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ACEBUTOLOL HYDROCHLORIDE- ACEBUTOLOL HYDROCHLORIDE CAPSULE
MARLEX PHARMACEUTICALS INC
----------
ACEBUTOLOL HYDROCHLORIDE CAPSULES
ACEBUTOLOL HYDROCHLORIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Acebutolol HCl, 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
HCl capsules, USP are provided in two dosage strengths which contain
200 mg 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, stearic
acid and titanium dioxide.
Acebutolol HCl, USP has the following structural formula:
18
28
2
4
Acebutolol HCl, 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 cardio selective, β-adrenoreceptor blocking agent,
which possesses mild
intrinsic sympathomimetic activity (ISA) in its therapeutically
effective dose range.
PHARMACODYNAMICS
β
-cardio selectivity 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 isoproterenol-induced vasodilatation (β
).
In guinea pigs and cats, it is more potent in antagonizing this
tachycardia than in
antagonizing isoproterenol-induced bronchodilation (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,
C
H
N
O
•HCl
M.W. 372.89
1
1
2
2
but only with high concentrations of acebutolol.
Clinical studies have demonstrated β
-blocking activity at the recommended doses by