Names and pronunciation
(sot′ah-lahl) Betapace, Betapace AF, Sorine, Sotylize
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Drug reference
(sot′ah-lahl) Betapace, Betapace AF, Sorine, Sotylize
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Func. class.: Antidysrhythmic group III
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Chem. class.: Nonselective β-blocker
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Do not confuse: sotalol/Sudafed
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ACTION: Blockade of β1- and β2- receptors leads to antidysrhythmic effect, prolongs action potential in myocardial fibers without affecting conduction, pro- longs QT interval, no effect on QRS duration
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USES: Life-threatening ventricular dys- rhythmias; Betapace AF: to maintain sinus rhythm with symptomatic atrial fibrillation/flutter
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Unlabeled uses: Atrial fibrillation pro- phylaxis, cardiac surgery, PSVT, Wolff- Parkinson-White (WPW) syndrome
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CONTRAINDICATIONS: Hyper- sensitivity to β-blockers, cardiogenic shock, heart block (2nd/3rd degree), sinus bradycardia, HF, bronchial asthma, CCr <40 mL/min, hypokalemia
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Black Box Warning: Congenital or ac- quired long QT syndrome Precautions: Pregnancy, breastfeeding, major surgery, diabetes mellitus, renal/thy- roid disease, COPD, well-compensated heart failure, CAD, nonallergic broncho- spasm, electrolyte disturbances, bradycar- dia, peripheral vascular disease Black Box Warning: Cardiac dysrhyth- mias, torsades de pointes, ventricular dysrhythmias, ventricular fibrillation; re- quires a specialized care setting Black Box Warning: Increase: QT pro- longation—class IA/III antidysrhythmics, some phenothiazines, β agonists, local anesthetics, tricyclics, haloperidol, chlo- roquine, droperidol, pentamidine; CYP3A4 inhibitors (amiodarone, clarithromycin, erythromycin, telithromycin, troleandomy- cin), arsenic trioxide; CYP3A4 substrates (methadone, pimozide, QUEtiapine, quiNI- Dine, risperiDONE, ziprasidone) Increase: hypoglycemia effect—insulin Increase: effects of lidocaine Increase: hypotension—diuretics, other antihypertensives, nitroglycerin β-blocker Decrease: effects— sympathomimetics Decrease: bronchodilating effects of the- ophylline, β2-agonists Decrease: hypoglycemic effects of sulfonylureas Drug/Lab Test False increase: urinary catecholamines Interference: glucose, insulin tolerance tests Drug/Herb • Do not use with hawthorn Black Box Warning: Requires a special- ized care setting: for a minimum of at least 3 days on maintenance dose with continuous ECG monitoring; calculate creatinine clearance before dosing Black Box Warning: Cardiogenic shock, acute pulmonary edema: do not use, ef- fect can further depress cardiac output Black Box Warning: QT syndrome: api- cal/radial pulse before administration: no- tify prescriber of any significant changes; monitor ECG continuously (Betapace AF); use QT interval to determine patient eligi- bility; baseline QT must be ≤450 msec, if ≥500 msec, frequency or dosage must be decreased or drug discontinued S • Baselines of renal studies before ther- apy begins • Abrupt discontinuation: do not dis- continue abruptly, taper over 1-2 wk • Dose should be adjusted slowly, with at least 3 days between changes; monitor ECG for QT interval • Monitor electrolytes (hypokalemia, hypomagnesemia); may increase dys- rhythmias • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; do not breastfeed, excreted in breast milk
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SIDE EFFECTS CNS: Dizziness, mental changes, drowsi- ness, fatigue, headache, depression, anxiety, paresthesia, insomnia, decreased concentration CV: Prodysarrhythmia, prolonged QT, orthostatic hypotension, HF, ventricular dysrhythmias, AV block, palpitations, tor- sades de pointes; life-threatening ven- tricular dysrhythmias (Betapace AF) EENT: Tinnitus, visual changes GI: Nausea, vomiting, diarrhea, dry mouth, constipation, anorexia GU: Impotence, dysuria INTEG: Rash, alopecia, urticaria, pruri- tus, fever, diaphoresis MS: Arthralgia, muscle cramps RESP: Bronchospasm, wheezing
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INTERACTIONS
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DOSAGE AND ROUTES Atrial fibrillation/atrial flutter • Adult: PO Initially, 80 mg bid; may in- crease in increments of 80 mg/day q3days if QTc is <500 msec; 320 mg/day; IV Initially, 75 mg bid; may increase by 75 mg/day q3days if the QTc is <500 msec; max 300 mg/day Life-threatening tachycardia • Adult: PO Initially, 80 mg bid; may in- crease by 80 mg/day q3days if the QTc is <500 msec to 160-320 mg/day. 480- 640 mg/day may be used in refractory life-threatening arrhythmias; IV Initially, 75 mg bid; may increase by 75 mg/day q3days if the QTc is <500 msec to 150- 300 mg/day. 550-600 mg/day may be used in refractory life-threatening arrhythmias • Adolescent/child 6-17 yr (unlabeled): PO Initially, 30 mg/m2/dose tid titrated up as needed at intervals of ≥36 hr (max 60 mg/m2/dose tid) Renal dose • Betapace/Betapace AF and Sorine (both for ventricular arrhythmias) • Adult: CCr ≥60 mL/min: no change; CCr 30-59 mL/min: extend dosage interval to q24hr. Dose may be titrated after at least 5 doses; CCr 10-29 mL/min: extend dos- age interval to 36-48 hr according to clinical response. Dose may be titrated after at least 5 doses; CCr <10 mL/min: individualize Betapace/Betapace AF (for atrial fibrillation/atrial flutter), Sotylize, and intravenous (IV) sotalol • Adult: CCr ≥60 mL/min: no change; CCr 40-59 mL/min: extend dosage inter- val to q24hr. Dose may be titrated after at least 5 doses; CCr <40 mL/min: use is contraindicated
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Available forms: Tabs 80, 120, 160, 240 mg; (Betapace AF) 80, 120, 160 mg; inj 150 mg/10 mL (15 mg/mL)
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Administer: PO route • Before, at bedtime; tab may be crushed or swallowed whole; give 1 hr before or 2 hr after meals • Reduced dosage in renal dysfunction • Betapace and Betapace AF are not in- terchangeable • Do not give within 2 hr of antacids • Store in dry area at room temperature; do not freeze IV route • Dilute to vol of either 120 mL or 300 mL with D5W, LR • 75-mg dose: withdraw 6 mL sotalol inj (90 mg), add 114 mL diluent to make 120 mL (0.75 mg/mL); or withdraw 6 mL sotalol inj (90 mg), add 294 mL diluent to make 300 mL (0.3 mg/mL) • 112.5-mg dose: withdraw 9 mL so- talol inj (135 mL), add 111 mL diluent to make 120 mL (1.125 mg/mL); or withdraw 9 mL sotalol (135 mg), add 291 mL diluent to make 300 mL (0.45 mg/mL) • 150-mg dose: withdraw 12 mL of so- talol (180 mg), add 108 mL diluent to make 120 mL (1.5 mg/mL); or withdraw 12 mL sotalol (180 mg), add 288 mL diluent to make 300 mL (0.6 mg/mL) • Use infusion pump and infuse 100 or 250 mL over 5 hr at a constant rate
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Assess: • I&O, weight daily; edema in feet, legs daily • B/P, pulse q4hr; note rate, rhythm, quality • Potassium, magnesium levels
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Evaluate: • Therapeutic response: absence of life- threatening dysrhythmias
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Not to discontinue product abruptly; to taper over 2 wk or may precipitate an- gina; to take exactly as prescribed • Not to use antacids or OTC products containing α-adrenergic stimulants (na- sal decongestants, OTC cold prepara- tions) unless directed by prescriber • To report bradycardia, dizziness, con- fusion, depression, fever • To take pulse at home; advise patient when to notify prescriber • To avoid alcohol, smoking, sodium intake • To carry emergency ID to identify prod- uct being taken, allergies • To avoid hazardous activities if dizzi- ness present • To report symptoms of HF, including difficulty breathing, especially on exertion or when lying down; night cough, swelling of extremities • To wear support hose to minimize ef- fects of orthostatic hypotension • To monitor blood glucose if diabetic • That hospitalization will be required for ≥3 days
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PHARMACOKINETICS PO: Onset 1-2 hr, peak 2-4 hr, duration 8-12 hr; IV: onset 5-10 min, peak/duration unknown; half-life 12 hr, excreted unchanged in urine, crosses placenta, excreted in breast milk, protein binding 0%
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• Adolescent/child 6-17 yr (unlabeled): PO Initially, 30 mg/m2/dose tid titrated up as needed at intervals of ≥36 hr (max 60 mg/m2/dose tid) Renal dose
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