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:

Golden State Medical Supply, 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
GOLDEN STATE MEDICAL SUPPLY, INC.
----------
AMIODARONE HCL TABLETS, USP
RX ONLY
DESCRIPTION
Amiodarone HCl is a member of a new class of antiarrhythmic drugs with
predominantly Class III
(Vaughan Williams' classification) effects, available for oral
administration as light orange scored
tablets containing 200 mg of amiodarone hydrochloride, and light
yellow, scored tablets containing 400
mg of amiodarone hydrochloride. The inactive ingredients present are
colloidal silicon dioxide, corn
starch, D&C Lake yellow No. 10 (400 mg only), FD&C yellow #6 lake (200
mg only), FD&C yellow
#10 lake (200 mg only), anhydrous lactose, magnesium stearate and
povidone. Amiodarone is 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 I2NO •HCL MOLECULAR WEIGHT: 681.8
Amiodarone HCl 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 HCl 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)
noncompetitive α- and β-adrenergic inhibition.
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 electrophysiolo