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Amiodarone

Generic Name
Amiodarone
Brand Names
Nexterone, Pacerone
Drug Type
Small Molecule
Chemical Formula
C25H29I2NO3
CAS Number
1951-25-3
Unique Ingredient Identifier
N3RQ532IUT

Overview

Amiodarone is a benzofuran derivative, anti-arrhythmic drug used commonly in a variety of settings. Most known for its approved indication in life-threatening ventricular arrhythmias, it is also used off-label in the outpatient and inpatient setting for atrial fibrillation. Because of its ability to cause serious toxicity and possibly death, amiodarone use should be reserved for its approved indications, according to prescribing information.

Background

Amiodarone is a benzofuran derivative, anti-arrhythmic drug used commonly in a variety of settings. Most known for its approved indication in life-threatening ventricular arrhythmias, it is also used off-label in the outpatient and inpatient setting for atrial fibrillation. Because of its ability to cause serious toxicity and possibly death, amiodarone use should be reserved for its approved indications, according to prescribing information.

Indication

The FDA approved indications for amiodarone are recurrent ventricular fibrillation (VF) and recurrent hemodynamically unstable ventricular tachycardia (VT). The FDA emphasizes that this drug should only be given in these conditions when they are clinically documented and have not responded to normal therapeutic doses of other antiarrhythmic agents, or when other drugs are not tolerated by the patient. Off-label indications include atrial fibrillation and supraventricular tachycardia.

Associated Conditions

  • Atrial Fibrillation
  • Supraventricular Tachycardia (SVT)
  • Recurrent Ventricular fibrillation
  • Recurrent hemodynamically unstable Ventricular tachycardia

FDA Approved Products

Amiodarone Hydrochloride
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2010/11/17
NDC:54868-4618
Amiodarone Hydrochloride
Manufacturer:Wockhardt Limited
Route:INTRAVENOUS
Strength:50 mg in 1 mL
Approved: 2012/11/06
NDC:55648-780
Amiodarone Hydrochloride
Manufacturer:Cardinal Health 107, LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2021/06/28
NDC:55154-3365
NEXTERONE (AMIODARONE HCI)
Manufacturer:HF Acquisition Co LLC, DBA HealthFirst
Route:INTRAVENOUS
Strength:1.5 mg in 1 mL
Approved: 2024/02/19
NDC:51662-1480
PACERONE
Manufacturer:Physicians Total Care, Inc.
Route:ORAL
Strength:200 mg in 1 1
Approved: 2011/05/12
NDC:54868-5186

Singapore Approved Products

CORDARONE INJECTION 150 mg/3 ml
Manufacturer:SANOFI WINTHROP INDUSTRIE, Delpharm Dijon
Form:INJECTION
Strength:150 mg/3 ml
Online:Yes
Approved: 1988/05/06
Approval:SIN00852P
CORDARONE TABLET 200 mg
Manufacturer:SANOFI WINTHROP INDUSTRIE
Form:TABLET
Strength:200 mg
Online:Yes
Approved: 1998/05/27
Approval:SIN09784P
DIOLUX CONCENTRATE FOR SOLUTION FOR INJECTION 50MG/ML
Manufacturer:Gland Pharma Ltd.
Form:INJECTION, SOLUTION, CONCENTRATE
Strength:50mg/mL
Online:Yes
Approved: 2019/08/16
Approval:SIN15782P

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