Dosing & Uses
Dosage Forms & Strengths
Ventricular & Supraventricular Arrhythmias
Betapace or Sorine: 80 mg PO q12hr initially; increased PRN to 120-160 mg q12hr (2-3 days between increments)
IV (substitute for PO): 75 mg over 5 hr q12hr initially; adjusted if necessary (on basis of monitoring of clinical efficacy, QTc interval, and adverse effects) every 3 days; not to exceed 150 mg q12hr
Refractory Life-Threatening Ventricular Arrhythmias
Betapace or Sorine: 80 mg PO q12hr initially; increased PRN to 120-160 mg q12hr (2-3 days between increments) to 160-320 mg/day divided q8-12hr; up to 480-640 mg/day may be required if benefits outweigh increased adverse effects
75 mg IV over 5 hr q12hr initially; adjusted if necessary every 3 days; not to exceed 150 mg IV q12hr
Betapace AF: 80 mg PO q12hr; increased PRN to 120-160 mg q12hr
Renal Impairment in Atrial Fibrillation/Flutter (Betapace AF)
- CrCl >60 mL/min: Give q12hr
- CrCl 40-60 mL/min: Give once daily
- CrCl <40 mL/min: Contraindicated
Renal Impairment in Ventricular Arrhythmia (Betapace, Sorine)
- CrCl >60 mL/min: Give q12hr
- CrCl 30-59 mL/min: Give once daily
- CrCl 10-29 mL/min: Give q36-48hr
- CrCl <10 mL/min: Individualize dosing
Dosage Forms & Strengths
<2 years old: Reduce dose; see manufacturer's package insert for details
Ventricular Arrhythmias (Orphan)
Orphan designation for treatment of life-threatening ventricular arrhythmias in pediatric patients
- Arbor Pharmaceuticals, LLC; 980 Hammond Drive, Bldg Two, Suite 1250; Atlanta, GA 30328
Serious - Use Alternative
Significant - Monitor Closely
Chest pain (16%)
Sleep disturbances (8%)
Abnormal ECG (7%)
Extremity pain (7%)
Mental confusion (6%)
Congestive heart failure (5%)
Torsades de pointes or new ventricular tachycardia/fibrillation in patients with supraventricular arrhythmia (4%)
Peripheral vascular disorders (3%)
Proarrhythmic effect (1.5-2%)
Torsades de pointes with history of sustained ventricular tachycardia (1%)
Frequency Not Defined
Catechol hypersensitivity after abrupt withdrawal
Increased insulin requirement in diabetics
Black Box Warnings
Hospitalize patient at least 3 days while on maintenance dose in facility that provides cardiac resuscitation, continuous ECG monitoring, and estimated CrCl
Calculate CrCl before initiating sotalol therapy
Sotalol has proarrhythmic effects and can cause life-threatening ventricular tachycardia associated with QT interval prolongation; reduce dose, prolong infusion time, or discontinue use if QTc is greater than 500 msec during therapy
Do not substitute sotalol for sotalol AF, because of significant differences in labeling (ie, patient package insert, dosing administration, safety information)
Betapace AF indicated for atrial fibrillation; Betapace indicated for ventricular arrhythmias
Asthma, sinus bradycardia, sick sinus syndrome or 2°/3° AV block unless pacemaker in place
Prolonged QT syndromes, cardiogenic shock, uncontrolled congestive heart failure, hypersensitivity, hypokalemia (<4 mEq/L), hypomagnesemia
Betapace AF & IV: CrCl <40 mL/min
Easily reversible atrial fibrillation/flutter
QT interval >450 ms when treating for AFIB
May worsen arrhythmias
May cause or worsen congestive heart failure
Long-term administration of beta blockers should not be routinely discontinued before major surgery; however, impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures
Formulations indicated for ventricular and atrial arrhythmias are different (eg, Betapace versus Betapace AF); follow instructions as applicable
Antacids given 2 hours or less before sotalol may reduce bioavailability
Reduce or discontinue therapy if QT prolongation, bradycardia, AV block, hypotension, worsening or heart failure occur
Do not discontinue abruptly; acute exacerbation of coronary artery disease may occur upon abrupt cessation of therapy
Correct any electrolyte disturbances
May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor
Pregnancy & Lactation
Pregnancy category: B
Lactation: Drug present in breast milk; do not nurse while taking
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Antiarrhythmic: Class II (beta blockade) and class III (action potential prolongation) properties
Has adrenoceptor-blocking effect and markedly prolongs action potential and repolarization
Onset: IV, 1-2 hr; 5-10 min for ongoing VT
Peak plasma time: 2.5-4 hr
Protein bound: None
Vd: 1.2-2.4 L/kg
Half-life: Adults, 12 hr; children, 9.5 hr; prolonged in renal impairment
Excretion: Urine (unchanged)
Vial is 10 mL
Dilute with NS, D5W, or lactated Ringer solution to 100-250 mL
80 mg PO = 75 mg IV; 120 mg PO = 112.5 mg IV; 160 mg PO = 150 mg IV
Infuse over 5 hours
Monitor QT interval
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