BETAPACE AF

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Generic Name for BETAPACE AF

Sotalol HCl 80mg, 120mg, 160mg; scored tabs.

Legal Classification:

Rx

Pharmacological Class for BETAPACE AF

Class II and III antiarrhythmic.

Manufacturer of BETAPACE AF

Bayer Corp, Pharmaceutical Div.

Indications for BETAPACE AF

Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation or atrial flutter who are currently in sinus rhythm.

Adult dose for BETAPACE AF

Initiate only in appropriate clinical setting that can provide continuous ECG, creatinine clearance monitoring, and cardiac resuscitation. If QT ≤450msec and CrCl>60mL/min: initially 80mg twice daily. Renal impairment (CrCl 40–60mg/mL): initially 80mg once daily; <40mL/min: see Contraindications. See literature for dose titration and required monitoring.

Children's dosing for BETAPACE AF

Not recommended.

Contraindications for BETAPACE AF

Sinus bradycardia (<50bpm). Sick sinus syndrome. 2nd or 3rd degree AV block, unless paced. Baseline QT interval >450msec. Long QT syndromes. Cardiogenic shock. Uncontrolled heart failure (patients with NYHA Class IV may not tolerate beta-blockade; titrate slowly and give full support if attempting to use sotalol in these patients). Renal impairment (CrCl<40mL/min). Hypokalemia (<4mEq/L). Asthma.

Warnings/Precautions for BETAPACE AF

Not for use in easily-reversible AFIB/AFL. Do not use for asymptomatic atrial fibrillation/flutter. Do not substitute for Betapace. Reduce dose or discontinue if QT interval ≥500msec occurs. Correct electrolyte imbalances (esp. hypokalemia, hypomagnesemia) before starting sotalol. Bronchospastic disease. CHF. Left ventricular dysfunction. Diabetes. Acid-base imbalance. Avoid abrupt cessation (withdraw over 1–2 weeks if possible, monitor for angina and acute coronary insufficiency). Increased arrhythmia risk in females, renal impairment, excessive QTc prolongation, history of cardiomegaly or CHF, sustained ventricular tachycardia, electrolyte disturbances, or with high doses of sotalol. Hyperthyroidism. Surgery. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions for BETAPACE AF

Class IA antiarrhythmics (e.g., disopyramide, quinidine, procainamide), Class III antiarrhythmics (e.g., amiodarone), or other drugs that prolong QT interval (e.g., some phenothiazines, cisapride, bepridil, tricyclic antidepressants, macrolides): not recommended. Withhold Class I and III antiarrhythmics for at least 3 half-lives before starting sotalol. 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.

Adverse Reactions for BETAPACE AF

Fatigue, dizziness, bradycardia, new or exacerbated arrhythmias (e.g., torsade de pointes), dyspnea, ECG abnormalities, GI or visual disturbances, headache, insomnia.

How is BETAPACE AF supplied?

Tabs—60

Related Disease:

CHF and arrhythmias {CHF and arrhythmias}

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