PACERONE (amiodarone hydrochloride)
PACERONE is indicated for the treatment of Ventricular Fibrillation; Ventricular Tachycardia.
How PACERONE Works
Amiodarone is a Class III antiarrhythmic that exhibits electrophysiologic characteristics of all four Vaughan Williams classes. It blocks sodium (Class I), potassium (Class III), and calcium channels (Class IV), and exerts noncompetitive antisympathetic activity (Class II). These actions result in slowed conduction, prolongation of the cardiac action potential, and an increased refractory period in all cardiac tissues. Additionally, its vasodilatory properties reduce cardiac workload and myocardial oxygen consumption.
Details
- Status
- Prescription
- First Approved
- 1998-04-30
- Routes
- ORAL
- Dosage Forms
- TABLET
PACERONE Approval History
What PACERONE Treats
2 indicationsPACERONE is approved for 2 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Fibrillation
- Ventricular Tachycardia
PACERONE Boxed Warning
PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Pacerone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time . Obtain a ba...
WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Pacerone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time . Obtain a baseline chest X-ray and pulmonary-function tests, including diffusion capacity, when Pacerone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months [see Warnings and Precautions 5.2) ] . Pacerone can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue Pacerone if the patient experiences signs or symptoms of clinical liver injury [see Warnings and Precautions (5.3) ] . Pacerone can exacerbate arrhythmias. Initiate amiodarone hydrochloride in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available [see Warnings and Precautions (5.4) ] . WARNING: PULMONARY, HEPATIC, and CARDIAC TOXICITY See full prescribing information for complete boxed warning. Reserve Pacerone for patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity, some also life-threatening. Utilize alternative agents first. ( 1 ) Pacerone' s life-threatening toxicities include pulmonary ( 5.2 ), hepatic ( 5.3 ), and proarrhythmic ( 5.4 ). Initiate under hospital or specialist supervision. ( 5 )
PACERONE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PACERONE
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04594746 AAA | REB20-1555 | Ph 4 | terminated | Oral Amiodarone for Acute Cardioversion of Atrial Fibrillation Study |
| NCT06067438 | STUDY00021572 NCI-2023-03642, STUDY00021572 | Ph 2 | recruiting | Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PACERONE FDA Label Details
Indications & Usage
FDA Label (PDF)PACERONE is indicated for the treatment of Ventricular Fibrillation; Ventricular Tachycardia.
WARNING: PULMONARY, HEPATIC and CARDIAC TOXICITY Pacerone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity [see Indications and Usage (1) ] . Pacerone can cause pulmonary toxicity (hypersensitivity pneumonitis...
Track PACERONE with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.