SORINE (sotalol hydrochloride)
SORINE is indicated for the treatment of Ventricular Arrhythmia; Atrial Fibrillation; Atrial Flutter; Ventricular Tachycardia.
How SORINE Works
This medication works by combining two distinct antiarrhythmic actions: it blocks beta-adrenoreceptors and prolongs the duration of the cardiac action potential. While the beta-blocking effect reduces the heart rate, the prolongation of the action potential helps stabilize the heart's electrical signals to prevent irregular rhythms.
Details
- Status
- Prescription
- First Approved
- 2001-04-27
- Routes
- ORAL
- Dosage Forms
- TABLET
SORINE Approval History
What SORINE Treats
4 indicationsSORINE is approved for 4 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Ventricular Arrhythmia
- Atrial Fibrillation
- Atrial Flutter
- Ventricular Tachycardia
SORINE 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.
SORINE 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 SORINE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SORINE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SORINE
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.
SORINE FDA Label Details
Indications & Usage
SORINE is indicated for the treatment of Ventricular Arrhythmia; Atrial Fibrillation; Atrial Flutter; Ventricular Tachycardia.
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.