ACEBUTOLOL HYDROCHLORIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Amneal Pharmaceuticals of New York LLC

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Hypertension Acebutolol HCl 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 HCl 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 ).

Rezumat produs:

Acebutolol HCl 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 53746-669-01 Bottles of 500                         NDC 53746-669-05 400 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 30                           NDC 53746-670-30 Bottles of 100                         NDC 53746-670-01 Bottles of 500                         NDC 53746-670-05 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. Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad, 382213 India Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2017-00

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

ACEBUTOLOL HYDROCHLORIDE- ACEBUTOLOL HYDROCHLORIDE CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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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:
C
H
N O •HCl
M.W. 372.89
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 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 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
acebutolol has been
18
28
2
4
1
1
2
2
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 res