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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/19 | Phase 3 | Not yet recruiting | Versailles Hospital | ||
2024/12/19 | Not Applicable | Not yet recruiting | |||
2024/12/09 | Phase 3 | Not yet recruiting | Jilin Heart Hospital | ||
2024/11/08 | Phase 3 | Recruiting | |||
2024/10/16 | Phase 4 | Not yet recruiting | Institut Investigacio Sanitaria Pere Virgili | ||
2024/02/16 | Phase 4 | Completed | Police General Hospital, Thailand | ||
2023/10/04 | Phase 2 | Recruiting | |||
2023/05/03 | Phase 3 | Recruiting | |||
2022/09/22 | Phase 3 | Recruiting | Hippocration General Hospital | ||
2022/09/16 | Phase 4 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-1231 | INTRAVENOUS | 50 mg in 1 mL | 5/7/2025 | |
| Aphena Pharma Solutions - Tennessee, LLC | 67544-570 | ORAL | 200 mg in 1 1 | 5/9/2014 | |
| Medical Purchasing Solutions, LLC | 71872-7149 | INTRAVENOUS | 150 mg in 3 mL | 5/16/2023 | |
| Bryant Ranch Prepack | 71335-0881 | ORAL | 200 mg in 1 1 | 6/30/2020 | |
| Advagen Pharma Limited | 72888-039 | ORAL | 200 mg in 1 1 | 4/14/2021 | |
| Upsher-Smith Laboratories, LLC | 0245-0144 | ORAL | 100 mg in 1 1 | 9/24/2020 | |
| Dr. Reddy's Labratories Inc. | 75907-007 | ORAL | 400 mg in 1 1 | 3/15/2024 | |
| Chartwell RX, LLC | 62135-576 | ORAL | 100 mg in 1 1 | 8/23/2023 | |
| Upsher-Smith Laboratories, LLC | 0245-1645 | ORAL | 400 mg in 1 1 | 9/24/2020 | |
| American Health Packaging | 60687-437 | ORAL | 200 mg in 1 1 | 9/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| CORDARONE INJECTION 150 mg/3 ml | SIN00852P | INJECTION | 150 mg/3 ml | 5/6/1988 | |
| CORDARONE TABLET 200 mg | SIN09784P | TABLET | 200 mg | 5/27/1998 | |
| DIOLUX CONCENTRATE FOR SOLUTION FOR INJECTION 50MG/ML | SIN15782P | INJECTION, SOLUTION, CONCENTRATE | 50mg/mL | 8/16/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amiodarone Hydrochloride Capsules | 国药准字H32023766 | 化学药品 | 胶囊剂 | 7/22/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H11020705 | 化学药品 | 胶囊剂 | 11/2/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H50020462 | 化学药品 | 胶囊剂 | 4/20/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H44020429 | 化学药品 | 胶囊剂 | 4/13/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H32023765 | 化学药品 | 胶囊剂 | 7/22/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H23021766 | 化学药品 | 胶囊剂 | 4/25/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H13020798 | 化学药品 | 胶囊剂 | 7/31/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H41021026 | 化学药品 | 胶囊剂 | 4/22/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H50020463 | 化学药品 | 胶囊剂 | 5/6/2020 | |
| Amiodarone Hydrochloride Capsules | 国药准字H44020430 | 化学药品 | 胶囊剂 | 4/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| AMIODARONE SANDOZ amiodarone hydrochloride 200mg tablet blister pack | 77739 | Medicine | A | 3/2/2001 | |
| CORDARONE X 100 amiodarone hydrochloride 100mg tablet blister pack | 15359 | Medicine | A | 9/30/1991 | |
| AMIODARONE JUNO amiodarone hydrochloride 150mg/3mL solution for injection ampoule | 233673 | Medicine | A | 2/4/2016 | |
| CORDARONE X 200 amiodarone hydrochloride 200mg tablet blister pack | 15361 | Medicine | A | 9/30/1991 | |
| Cordarone X Intravenous 150mg/3mL Injection | 15360 | Medicine | A | 9/30/1991 | |
| AMDARONE amiodarone hydrochloride 200 mg tablet blister pack | 339110 | Medicine | A | 7/23/2020 | |
| Amiodarone hydrochloride 200 mg tablet bulk | 381191 | Medicine | A | 12/22/2021 | |
| ARATAC 100 Tablet | 32519 | Medicine | A | 10/30/1991 | |
| ARATAC 200 Tablet | 32514 | Medicine | A | 10/30/1991 |