BETAPACE (sotalol hydrochloride)
BETAPACE is indicated for the treatment of Ventricular Arrhythmia; Atrial Fibrillation; Atrial Flutter.
How BETAPACE Works
Sotalol hydrochloride is a non-cardioselective beta-adrenergic blocker that exhibits both Vaughan Williams Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) antiarrhythmic properties. By inhibiting beta-receptors and prolonging the refractory period of cardiac tissue, it slows the heart rate and stabilizes cardiac rhythm. While beta-blockade is evident at low doses, significant Class III electrophysiologic effects are dose-dependent and typically seen at higher daily doses.
Details
- Status
- Prescription
- First Approved
- 1992-10-30
- Routes
- ORAL
- Dosage Forms
- TABLET
BETAPACE Approval History
What BETAPACE Treats
3 indicationsBETAPACE is approved for 3 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Arrhythmia
- Atrial Fibrillation
- Atrial Flutter
BETAPACE Boxed Warning
LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate do...
WARNING: LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Calculate creatinine clearance to determine appropriate dosing [see Dosage and Administration ( 2.5 ) ] . WARNING: LIFE-THREATENING PROARRHYTHMIA See full prescribing information for complete boxed warning. Betapace/Betapace AF can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.
BETAPACE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 BETAPACE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BETAPACE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BETAPACE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
BETAPACE FDA Label Details
Indications & Usage
FDA Label (PDF)BETAPACE is indicated for the treatment of Ventricular Arrhythmia; Atrial Fibrillation; Atrial Flutter.
WARNING: LIFE-THREATENING PROARRHYTHMIA To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.