AMIODARONE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

AMIODARONE HYDROCHLORIDE

Composition:

AMIODARONE HYDROCHLORIDE 200 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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AMIODARONE HYDROCHLORIDE TABLETS
DESCRIPTION
Amiodarone hydrochloride is a member of a class of antiarrhythmic
drugs with predominantly Class III
(Vaughan Williams' classification) effects. Amiodarone is a benzofuran
derivative: 2-butyl-3-
benzofuranyl 4-[2-(diethylamino)-ethoxy]-3,5-diiodophenyl ketone
hydrochloride.
The structural formula is as follows:
Amiodarone hydrochloride, USP 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.
Each amiodarone hydrochloride tablet intended 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 sodium starch glycolate.
CLINICAL PHARMACOLOGY
ELECTROPHYSIOLOGY/MECHANISMS OF ACTION:
In animals, amiodarone is effective in the prevention or suppression
of experimentally induced
arrhythmias. The antiarrhythmic effect of amiodarone may be due to at
least two major properties:
1. a prolongation of the myocardial cell-action potential duration and
refractory period and
2. non-competitive antagonism of α- and β-adrenoceptors.
Amiodarone 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 increases the cardiac
refractory period without
influencing resting membrane potential, except in automatic cells
where the slope of the prepotential is
reduced, generally reducing automaticity. These electrophysiologic
effects are reflected in a
decreased sinus rate of 15 to 20%, increased PR and QT intervals of
about 10%, the development of U-
waves, and changes in T-wave contour. These changes should not require
discontinuation of
amiodarone a