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Sotalol

    Brands

    DEA Class; Rx

    Common Brand Names; Betapace, Betapace AF, Sorine, Sotylize

    • Antidysrhythmics, II; 
    • Antidysrhythmics, III; 
    • Beta-Blockers, Nonselective

    Nonselective beta-adrenergic blocking agent and class III antiarrhythmic
    Used for the treatment of atrial fibrillation, atrial flutter, and life-threatening ventricular arrhythmias
    May induce QT prolongation and torsade de pointes

    Indicated for treatment of life-threatening ventricular tachycardia; antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias

    Indicated for maintenance of normal sinus rhythm in patient with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) who are currently in sinus rhythm

    Indicated for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm.

    Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemaker

    Congenital or acquired long QT syndromes, QT interval >450 ms

    Cardiogenic shock, decompensated heart failure

    Serum potassium <4 mEq/L

    Bronchial asthma or related bronchospastic conditions

    Known hypersensitivity to sotalol

    • Dyspnea (21%)
    • Dizziness (20%)
    • Fatigue (20%)
    • Bradycardia (16%)
    • Chest pain (16%)
    • Palpitation (14%)
    • Weakness (13%)
    • Lightheadedness (12%)
    • Nausea/vomiting (10%)
    • Edema (8%)
    • Headache (8%)
    • Sleep disturbances (8%)
    • Abnormal ECG (7%)
    • Diarrhea (7%)
    • Extremity pain (7%)
    • Hypotension (6%)
    • Mental confusion (6%)
    • Congestive heart failure (5%)
    • Itching/rash (5%)
    • Syncope (5%)
    • Anxiety (4%)
    • Depression (4%)
    • Torsades de pointes or new ventricular tachycardia/fibrillation in patients with supraventricular arrhythmia (4%)
    • Peripheral vascular disorders (3%)
    • Impotence (2%)
    • Proarrhythmic effect (1.5-2%)
    • Torsades de pointes with history of sustained ventricular tachycardia (1%)
    • Catechol hypersensitivity after abrupt withdrawal
    • Increased insulin requirement in diabetics

    Significant reductions of both systolic and diastolic blood pressure may occur; monitor hemodynamics in patients with marginal cardiac compensation

    New onset or worsening heart failure may occur during initiation or uptitration of sotalol owing to its beta-blocking effects; monitor for signs and symptoms of heart failure and discontinue treatment if symptoms occur

    Patients with bronchospastic diseases (eg, chronic bronchitis, emphysema) should not receive beta-blockers; if sotalol must be used, use smallest effective dose to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta2 receptors

    May mask sign of hypoglycemia (ie, tachycardia)

    Avoid abrupt withdrawal in patients with thyroid disease, as it may exacerbate symptoms of hyperthyroidism

    While taking beta-blockers, patients with a history of anaphylactic reaction to allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic; may be unresponsive to usual epinephrine doses

    Chronically administered beta-blocking therapy should not be routinely withdrawn before major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures

    This drug should not be administered to a pregnant woman unless clinical benefit outweighs potential risk to fetus

    The excretion of ibutilide into breast milk has not been studied; accordingly, breastfeeding should be discouraged during therapy with this drug

    Adults

    320 mg/day PO for atrial fibrillation/atrial flutter; 640 mg/day PO for life-threatening ventricular arrhythmias; 600 mg/day IV.

    Geriatric

    320 mg/day PO for atrial fibrillation/atrial flutter; 640 mg/day PO for life-threatening ventricular arrhythmias; 600 mg/day IV.

    Adolescents

    Safety and efficacy have not been established; 180 mg/m2/day or 7.2 mg/kg/day PO is the maximum dosage recommended by FDA-approved labeling; alternatively, doses up to 10 mg/kg/day PO have been used for the management of various tachyarrhythmias.

    Children

    2 to 12 years: Safety and efficacy have not been established; 180 mg/m2/day or 7.2 mg/kg/day PO is the maximum dosage recommended by FDA-approved labeling; alternatively, doses up to 10 mg/kg/day PO have been used for the management of various tachyarrhythmias.
    1 year: Safety and efficacy have not been established; see full prescribing information for age-specific dosing chart; doses up to 10 mg/kg/day PO have been used for the management of various tachyarrhythmias.

    Infants

    Safety and efficacy have not been established; see full prescribing information for age-specific dosing chart; doses up to 10 mg/kg/day PO have been used for the management of various tachyarrhythmias.

    Neonates

    Safety and efficacy have not been established; see full prescribing information for age-specific dosing chart; doses up to 10 mg/kg/day PO have been used for the management of various tachyarrhythmias.

    Sotalol hydrochloride

    tablet (Betapace, Betapace AF, Sorine, generic)

    • 80mg
    • 120mg
    • 160mg

    oral solution

    • 5mg/mL (Sotylize)

    injectable solution

    • 15mg/mL