Generic Name and Formulations:
Sotalol HCl 80mg, 120mg, 160mg, 240mg; scored tabs.
Indications for BETAPACE:
Documented life-threatening ventricular arrhythmias.
Initiate and titrate up in hospital with appropriate monitoring. Initially 80mg twice daily. Increase at 3-day intervals to usual maintenance 120–160mg twice daily; usual range 160–320mg/day divided in 2 or 3 doses (refractory patients may need 480–640mg/day). Renal impairment (CrCl <60mL/min): prolong dosing interval (see full labeling).
Sinus bradycardia. 2nd or 3rd degree AV block unless paced. Long QT syndromes. Cardiogenic shock. Uncontrolled CHF (patients with NYHA Class IV may not tolerate beta-blockade; titrate slowly and give full support if attempting to use sotalol in these patients). Asthma.
Do not substitute for Betapace AF. Increased arrhythmia risk in females, sustained ventricular tachycardia, electrolyte disorders (esp. hypokalemia, hypomagnesemia), excessive QT prolongation, history of cardiomegaly, CHF, renal impairment, and high doses. Correct electrolyte imbalances and withdraw other antiarrhythmics before starting. Baseline QTc interval >500msec; consider lowering dose or discontinuing if QTc interval exceeds 550msec. Sick sinus syndrome. Bronchospastic disease. CHF. Left ventricular dysfunction. Recent acute MI. Diabetes. Acid-base imbalance. Hyperthyroidism. History of anaphylaxis. Surgery. Avoid abrupt cessation (withdraw over 1–2 weeks if possible, monitor for angina and acute coronary insufficiency). Pregnancy (Cat.B). Nursing mothers: not recommended.
Class IA antiarrhythmics (eg, disopyramide, quinidine, procainamide), Class III antiarrhythmics (eg, amiodarone), or other drugs that prolong QT interval (eg, some phenothiazines, cisapride, bepridil, tricyclic antidepressants, macrolides): not recommended. Caution with Class IB and IC antiarrhythmics. Additive conduction abnormalities and hypotension with digitalis, β-blockers, calcium channel blockers. Hypotension, bradycardia with reserpine, guanethidine, other catecholamine-depleting drugs. Increased rebound hypertension when withdrawing clonidine. Diuretics (monitor electrolytes). Antagonizes albuterol, other β-agonists. Monitor antidiabetic agents. May block epinephrine. Avoid within 2 hours of aluminum- or magnesium-containing antacids.
Class II and III antiarrhythmic.
Dyspnea, fatigue, nervousness, bradycardia, chest pain, palpitation, asthenia, light-headedness, GI disturbances; sleep, respiratory, vascular or visual disorders; edema, headache, ECG abnormalities, hypotension, new or exacerbated arrhythmias (eg, torsade de pointes), syncope.
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