ACEBUTOLOL HYDROCHLORIDE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Pharmaceuticals Inc.

INN (Algemene Internationale Benaming):

ACEBUTOLOL HYDROCHLORIDE

Samenstelling:

ACEBUTOLOL 200 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. They may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. 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 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 samenvatting:

Acebutolol Hydrochloride Capsules, USP are available containing 200 mg or 400 mg of acebutolol as the hydrochloride salt. The 200 mg capsule is a hard-shell gelatin capsule with a medium orange opaque cap and medium orange opaque body filled with a white powder blend. The capsule is axially printed with MYLAN over 1200 in black ink on both the cap and the body. They are available as follows: NDC 0378-1200-01 bottles of 100 capsules The 400 mg capsule is a hard-shell gelatin capsule with a medium orange opaque cap and medium orange opaque body filled with a white powder blend. The capsule is axially printed with MYLAN over 1400 in black ink on both the cap and the body. They are available as follows: NDC 0378-1400-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. REVISED SEPTEMBER 2012 ACEB:R10

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ACEBUTOLOL HYDROCHLORIDE- ACEBUTOLOL HYDROCHLORIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Acebutolol hydrochloride 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 available in two strengths which contain 200 mg or 400 mg of
acebutolol as the hydrochloride
salt. The inactive ingredients are povidone, pregelatinized starch and
stearic acid. The empty gelatin
capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1,
FD&C Red No. 40,
gelatin, sodium lauryl sulfate and titanium dioxide. In addition, the
imprinting ink contains black iron
oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake,
FD&C Blue No. 2
Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and
shellac glaze.
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, beta-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 demonstrated in catecholamine-depleted rats by tachycardia
induced by intravenous administration
of this agent. A membrane-stabilizing effect has be