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BETAPACE AF
CHF and arrhythmias
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Drug Name:

BETAPACE AF Rx

Generic Name and Formulations:
Sotalol HCl 80mg, 120mg, 160mg; scored tabs.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

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:

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:

Not recommended.

Contraindications:

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:

Not for use in easily-reversible AFIB/AFL. Do not use for asymptomatic atrial fibrillation/flutter. Do not substitute for Betapace. 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. 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). Hyperthyroidism. Surgery. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:

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. 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.

Pharmacological Class:

Class II and III antiarrhythmic.

Adverse Reactions:

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

How Supplied:

Tabs—60

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