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SOTYLIZE
CHF and arrhythmias
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Drug Name:

SOTYLIZE Rx

Generic Name and Formulations:
Sotalol HCl 5mg/mL; oral soln; grape flavor.

Company:
Arbor Pharmaceuticals, LLC

Therapeutic Use:

Indications for SOTYLIZE:

Documented life-threatening ventricular arrhythmias. Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation or atrial flutter (AFIB/AFL) who are currently in sinus rhythm.

Limitations Of use:

Use in less severe arrhythmias even if symptomatic is not recommended. Avoid in asymptomatic ventricular premature contractions. Paroxysmal atrial fibrillation where AFIB/AFL is easily reversed (eg, Valsalva maneuver): not recommended.

Adult:

Initiate only in appropriate clinical setting that can provide cardiac resuscitation, continuous ECG, and creatinine clearance monitoring. Perform baseline ECG and calculate creatinine clearance. Ventricular arrhythmia: if QT <450msec and CrCl >60mL/min: initially 80mg twice daily. Renal impairment: (CrCl 40–60mL/min): initially 80mg once daily; (CrCl <40mL/min): not recommended. May increase in increments of 80mg/day every 3 days as needed, provided QT <500msec. Usual range 80–160mg once or twice daily; refractory patients may need 240–320mg once or twice daily. AFIB/AFL: if QT <450msec and CrCl >60mL/min: initially 80mg twice daily. Renal impairment: (CrCl 40–60mL/min): initially 80mg once daily; (CrCl <40mL/min): not recommended. If inadequate response and is tolerated with QT <520msec, may Increase at 3-day intervals to 160mg once or twice daily.

Children:

Initiate only in appropriate clinical setting that can provide cardiac resuscitation, continuous ECG, and creatinine clearance monitoring. Perform baseline ECG and calculate creatinine clearance. Ventricular arrhythmia: <2yrs: see full labeling for dose reductions. ≥2yrs: 30mg/m2 three times daily (90mg/m2 total daily dose). May titrate to max 60mg/m2. Allow at least 36hrs between dose increments to attain steady-state concentration.

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. Renal impairment (CrCl<40mL/min). Hypokalemia (<4mEq/L). Asthma.

Warnings/Precautions:

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. Monitor QT interval after each dose; reduce dose, increase interval, or discontinue if QT interval ≥500msec. Correct electrolyte imbalances (esp. hypokalemia, hypomagnesemia) before starting. Acid-base imbalance. CHF. Recent acute MI. Bronchospastic diseases. Diabetes. 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.

Interactions:

Class IA antiarrhythmics (eg, disopyramide, quinidine, procainamide), Class III antiarrhythmics (eg, amiodarone), or other drugs that prolong QT interval (eg, some phenothiazines, tricyclic antidepressants, certain oral macrolides or quinolones): not recommended. Withhold Class I and III antiarrhythmics for at least 3 half-lives before starting. Caution with Class IB and IC antiarrhythmics. Additive conduction abnormalities and hypotension with digoxin, 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, terbutaline, isoproterenol, 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, bradycardia, dizziness, headache, dyspnea, nausea, vomiting, diarrhea; QT prolongation, Torsade de Pointes, hypotension (monitor).

Generic Availability:

NO

How Supplied:

Soln—250mL, 480mL

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