BlackBoxRX
 
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Sotalol (Oral)

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

Dose Selection, Special Cautions in Renal Impairment

  • For detailed instructions regarding dose selection, and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION.

Betapace vs Betapace AF

  • Sotalol is also indicated for the treatment of life-threatening ventricular arrhythmias and is marketed under the brand name Betapace (sotalol hydrochloride tablets).
  • Sotalol AF is not approved for atrial fibrillation or flutter indication
  • Do not substitute Betapace (sotalol hydrochloride) for Betapace AF (sotalol hydrochloride AF). Betapace does not have atrial fibrillation indication or package insert information for patient

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Creatinine clearance should be calculated prior to dosing

Patient Counseling Information

Package Inserts

Sotalol

Updated April 2020