PROPAFENONE HYDROCHLORIDE · Aurobindo Pharma
Propafenone hydrochloride is an antiarrhythmic medication indicated to prolong the time to recurrence of symptomatic paroxysmal atrial fibrillation/flutter (PAF) and paroxysmal supraventricular tachycardia (PSVT) in patients without structural heart disease. It is also indicated for the treatment of life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia. Because of its proarrhythmic potential, treatment must be initiated in a hospital setting and is reserved for cases where the potential benefits outweigh the risks. It is not recommended for patients with permanent atrial fibrillation or for use as a rate-control agent.
How PROPAFENONE HYDROCHLORIDE Works
Propafenone is a Class 1C antiarrhythmic agent that stabilizes myocardial membranes by inhibiting the fast inward sodium current. This action reduces the upstroke velocity (Phase 0) of the action potential, increases the diastolic excitability threshold, and suppresses spontaneous automaticity. In addition to its sodium channel blockade, propafenone exhibits mild beta-adrenergic blocking activity (approximately 1/40th the potency of propranolol) and inhibits various cardiac potassium currents, contributing to its overall electrophysiological profile.
Details
- Status
- Prescription
- First Approved
- 1989-11-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET
Companies
PROPAFENONE HYDROCHLORIDE Approval History
What PROPAFENONE HYDROCHLORIDE Treats
5 indicationsPROPAFENONE HYDROCHLORIDE is approved for 5 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atrial Fibrillation
- Atrial Flutter
- Supraventricular Tachycardia
- Ventricular Tachycardia
- Ventricular Arrhythmias
PROPAFENONE HYDROCHLORIDE Boxed Warning
MORTALITY In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that s...
WARNING: MORTALITY In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. WARNING: MORTALITY See full prescribing information for complete boxed warning. An increased rate of death or reversed cardiac arrest rate was seen in subjects treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo. At present, it is prudent to consider any IC antiarrhythmic to have a significant risk of provoking proarrhythmic events in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
PROPAFENONE HYDROCHLORIDE 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.
What's emerging in PROPAFENONE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PROPAFENONE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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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.
PROPAFENONE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Propafenone hydrochloride tablets are indicated to: prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease. prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease. treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital. Usage Considerations: The use of propafenone...
WARNING: MORTALITY In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but ...
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Full clinical data, patents, trials, and competitive landscape for propafenone hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.