Application Nr Approved Date Route Status External Links
ANDA079029 2008-09-16 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Because Of Its Life-Threatening Side Effects And The Substantial Management Difficulties Associated With Its Use (see Warnings Below), Amiodarone Is Indicated Only For The Treatment Of The Following Documented, Life-Threatening Recurrent Ventricular Arrhythmias When These Have Not Responded To Documented Adequate Doses Of Other Available Antiarrhythmics Or When Alternative Agents Could Not Be Tolerated. Recurrent Ventricular Fibrillation. Recurrent Hemodynamically Unstable Ventricular Tachycardia. As Is The Case For Other Antiarrhythmic Agents, There Is No Evidence From Controlled Trials That The Use Of Amiodarone Hydrochloride Tablets Favorably Affects Survival. Amiodarone Should Be Used Only By Physicians Familiar With And With Access To (directly Or Through Referral) The Use Of All Available Modalities For Treating Recurrent Life-Threatening Ventricular Arrhythmias, And Who Have Access To Appropriate Monitoring Facilities, Including In-Hospital And Ambulatory Continuous Electrocardiographic Monitoring And Electrophysiologic Techniques. Because Of The Life-Threatening Nature Of The Arrhythmias Treated, Potential Interactions With Prior Therapy, And Potential Exacerbation Of The Arrhythmia, Initiation Of Therapy With Amiodarone Should Be Carried Out In The Hospital.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE ZINC3830212