AMIODARONE HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
12-01-2018

유효 성분:

AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)

제공처:

McKesson Contract Packaging

INN (국제 이름):

AMIODARONE HYDROCHLORIDE

구성:

AMIODARONE HYDROCHLORIDE 200 mg

처방전 유형:

PRESCRIPTION DRUG

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

                                AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
MCKESSON CONTRACT PACKAGING
----------
AMIODARONE HYDROCHLORIDE TABLETS, 200 MG
RX ONLY
DESCRIPTION
Amiodarone hydrochloride tablets are a member of a new class of
antiarrhythmic drugs with
predominantly Class III (Vaughan Williams’ classification) effects,
available for oral administration as
yellow, scored tablets. Each tablet for oral administration contains
200 mg of amiodarone
hydrochloride. In addition, each tablet contains the following
inactive ingredients: colloidal silicon
dioxide, corn starch, lactose monohydrate, magnesium stearate,
povidone, and D&C yellow No. 10
aluminum lake. Amiodarone hydrochloride tablets are a benzofuran
derivative: 2-butyl-3-benzofuranyl
4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone hydrochloride. It
is not chemically related to any
other available antiarrhythmic drug.
The structural formula is as follows:
C
H I NO • HCl Molecular Weight: 681.8
Amiodarone hydrochloride is a white to cream-colored crystalline
powder. It is slightly soluble in
water, soluble in alcohol, and freely soluble in chloroform. It
contains 37.3% iodine by weight.
CLINICAL PHARMACOLOGY
ELECTROPHYSIOLOGY/MECHANISMS OF ACTION
In animals, amiodarone hydrochloride is effective in the prevention or
suppression of experimentally
induced arrhythmias. The antiarrhythmic effect of amiodarone
hydrochloride may be due to at least two
major properties: 1) a prolongation of the myocardial cell-action
potential duration and refractory
period and 2) noncompetitive α- and β-adrenergic inhibition.
Amiodarone hydrochloride prolongs the duration of the action potential
of all cardiac fibers while
causing minimal reduction of dV/dt (maximal upstroke velocity of the
action potential). The refractory
period is prolonged in all cardiac tissues. Amiodarone hydrochloride
increases the cardiac refractory
period without influencing resting membrane potential, except in
automatic cells where the slope of the
prepotential is reduced, generally reducing automaticit
                                
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