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NEXTERONE contains amiodarone HCl (C₂₅H₂₉I₂NO₃•HCl), a class III antiarrhythmic drug. Amiodarone HC1 is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanonehydrochloride.

Amiodarone HC1 has the following structural formula:

Amiodarone HC1 is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. NEXTERONE is a sterile clear, colorless to slightly yellow solution visually free from particulates. Each mL of NEXTERONE contains 50 mg of amiodarone HC1,225 mg sulfobutylether beta-cyclodextrin sodium, 3.8 mg citric acid monohydrate, 2.1 mg sodium citrate dihydrate and water for injection. Sodium hydroxide or citric acid monohydrate may have been added to adjust pH. NEXTERONE does not contain polysorbate 80 or benzyl alcohol.

Last reviewed on RxList: 1/6/2012
This monograph has been modified to include the generic and brand name in many instances.