Sotalol (Betapace, Sorine) Considerations for Use*

US/FDA Approved Indications: Heart Rhythm Control for Atrial Fibrillation

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Black Box Warning* Patients should be in a facility for at least 3 days with ECG monitoring, cardiac resuscitation available, and C rCl calculated when initiat ing or re - initiating . Do not substitute Betapace for Betapace AF. Abrupt cessation may exacerbate angina pectoris and MI.

Mechanism of Action

Prolongs cardiac repolarization (Class III antiarrhythmic properties).

Dosing

Maintenance: 80 to 320 mg PO every 12 hrs, based on QTC interval and renal function

Hepatic Impairment: No adjustments needed

Renal Impairment: CrCl 40 - 60 mL/min: dose every 24 hours CrCl < 40 mL/min: contraindicated

Contraindications
  • Asthma
  • AV block
  • Bradycardia
  • decompensated heart failure
  • hypokalemia
  • pulmonary edema
  • QT prolongation
  • renal failure
  • sick sinus syndrome
  • Major Side Effects

    torsades de pointes, HF, bradycardia

    Dosage forms and Strengths

    PO: 80, 120, 160, 240 mg tablets

    IV: 150mg/10ml s olution fo r i njection

    Special Notes

    Non-selective beta-blocker. Avoid in patients with asthma.

    Potassium and magnesium levels should be within normal range prior to initiating and during therapy.

    To minimize the risk of induced arrhythmia, patients initiated or re - initiated on sotalol should be placed for a minimum of 3 days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.

    Monitor serum creatinine, magnesium, potassium, heart rate, blood pressure; EKG.

    Has many drug interactions. Abrupt cessation my precipitate angina, MI, arrhythmias, or rebound HTN; discontinue by tapering over 1-2 weeks.

    Do not substitute Betapace® for Betapace AF®

    Counseling

    Do not abruptly discontinue without physician’s advice.

    Report angina or signs/symptoms of congestive heart failure, new or worsened arrhythmias, or other cardiac dysfunction.

    Consult with a healthcare provider prior to new drug use (including OTC and herbals).

    * Refer to prescribing information for more complete information.
    †Dosages given in the table may differ from those recommended by the manufacturers.


    Sources:

    1. American College of Cardiology (ACC), American Heart Association (AHA), and the European Society of Cardiology (ESC). ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation. Washington, DC: American College of Cardiology.
    2. Heart Rhythm Society. AF360 Pocket Guide: Practical Rate and Rhythm Management of Atrial Fibrillation. 2010, Washington, DC: Heart Rhythm Society.
    3. Tarascon Pocket Pharmacopoeia® 2012.