sotalol (Betapace, Betapace AF, Sorine, Sotylize)

Dosing and uses of Betapace, Betapace AF (sotalol)

• Adult
• Pediatric

 

Adult dosage forms and strengths

tablet

• 80mg
• 120mg
• 160mg
• 240mg

oral solution

• 5mg/mL

injectable solution

• 15mg/mL

 

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

 

Atrial Fibrillation/Flutter

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

 

Dosing Modifications

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

 

Pediatric dosage forms and strengths

tablet

• 80mg
• 120mg
• 160mg
• 240mg

oral solution

• 5mg/mL

injectable solution

• 15mg/mL

 

Supraventricular Tachycardia

<2 years old: Reduce dose; see manufacturer's package insert for details

≥2 years old: 30 mg/m² PO q8hr initially; may be titrated up to 180 mg/m²/day PO

 

Ventricular Arrhythmias (Orphan)

Orphan designation for treatment of life-threatening ventricular arrhythmias in pediatric patients

Orphan sponsor

• Arbor Pharmaceuticals, LLC; 980 Hammond Drive, Bldg Two, Suite 1250; Atlanta, GA 30328

 

Betapace, Betapace AF (sotalol) adverse (side) effects

>10%

Dyspnea (21%)

Dizziness (20%)

Fatigue (20%)

Bradycardia (16%)

Chest pain (16%)

Palpitation (14%)

Weakness (13%)

Lightheadedness (12%)

 

1-10%

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%)

 

Frequency not defined

Catechol hypersensitivity after abrupt withdrawaL

Increased insulin requirement in diabetics

 

Warnings

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

 

Contraindications

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

 

Cautions

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 and lactation

Pregnancy category: B

Lactation: Drug present in breast milk; do not nurse while taking

 

Pregnancy categories

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.

 

Pharmacology of Betapace, Betapace AF (sotalol)

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

 

Absorption

Bioavailability: 90-100%

Onset: IV, 1-2 hr; 5-10 min for ongoing Vt

Peak plasma time: 2.5-4 hr

 

Distribution

Protein bound: None

Vd: 1.2-2.4 L/kg

 

Metabolism

None

 

Elimination

Half-life: Adults, 12 hr; children, 9.5 hr; prolonged in renal impairment

Excretion: Urine (unchanged)

 

Administration

IV Preparation

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

 

IV Administration

Infuse over 5 hours

Monitor QT intervaL