Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
Mylan Institutional Inc.
AMIODARONE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE 200 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET MYLAN INSTITUTIONAL INC. ---------- AMIODARONE HYDROCHLORIDE TABLETS RX ONLY DESCRIPTION Amiodarone hydrochloride is a member of a class of antiarrhythmic drugs with predominantly Class III (Vaughan Williams’ classification) effects, available for oral administration as pink, scored tablets containing 200 mg of amiodarone hydrochloride. The inactive ingredients present are: colloidal silicon dioxide, corn starch, FD&C Red 40, lactose monohydrate, magnesium stearate, and povidone. Amiodarone hydrochloride is a benzofuran derivative: 2-butyl-3-benzofuranyl 4-[2- (diethylamino)ethoxy]-3,5-diiodophenyl ketone hydrochloride. The structural formula is as follows: C H I NO •HCl M.W. 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 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: a prolongation of the myocardial cell-action potential duration and refractory period and 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 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 as they are ev Read the complete document