SOTALOL HYDROCHLORIDE
Sotalol hydrochloride treats serious, life-threatening heart rhythm disturbances such as sustained ventricular tachycardia. It also helps patients with highly symptomatic atrial fibrillation or flutter maintain a normal heart rhythm once it has been restored. This medication is specifically used for patients with significant symptoms and is not typically used for those whose heart rhythm issues are easily corrected or cause minimal distress.
How SOTALOL HYDROCHLORIDE Works
Sotalol hydrochloride works by combining beta-blocking activity with the ability to prolong the duration of the heart's electrical action potential. By targeting these pathways, the drug helps stabilize heart rhythms and slow the resting heart rate. While its beta-blocking effects are seen at lower doses, the stabilization of the heart's electrical timing typically occurs at higher dosage levels.
Details
- Status
- Discontinued
- First Approved
- 2000-05-01
- Patent Cliff
- 2039
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- TABLET, SOLUTION
Companies
SOTALOL HYDROCHLORIDE Approval History
What SOTALOL HYDROCHLORIDE Treats
4 indicationsSOTALOL HYDROCHLORIDE is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Arrhythmias
- Ventricular Tachycardia
- Atrial Fibrillation
- Atrial Flutter
SOTALOL HYDROCHLORIDE 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. 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. Initiate or reinitiate in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Adjust the dosing interval based on creatinine clearance.
SOTALOL HYDROCHLORIDE 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 SOTALOL HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SOTALOL HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SOTALOL HYDROCHLORIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
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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.
SOTALOL HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)SOTALOL HYDROCHLORIDE is indicated for the treatment of Ventricular Arrhythmias; Ventricular Tachycardia; 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...
SOTALOL HYDROCHLORIDE Patents & Exclusivity
Patents (7 active)
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Revenue Insights
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Patent Timeline
- • Cliff: 2039
- • 9 active patents
Trial Analysis
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- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.