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Sotylize Generic Name & Formulations
Legal Class
Rx
General Description
Sotalol HCl 5mg/mL; oral soln; grape flavor.
Pharmacological Class
Class II and III antiarrhythmic.
How Supplied
Soln—250mL, 480mL
Manufacturer
Generic Availability
NO
Sotylize Indications
Indications
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.
Sotylize Dosage and Administration
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.
Sotylize Contraindications
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.
Sotylize Boxed Warnings
Boxed Warning
Life-threatening proarrhythmia. Should be hospitalized in a facility that can provide cardiac resuscitation, continuous ECG monitoring, and calculations of creatinine clearance. Do not start if baseline QTc >450msec; if QT prolongs ≥500msec, reduce dose, increase dosing interval, or discontinue.
Sotylize Warnings/Precautions
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 during initiation and titration. Correct electrolyte imbalances (esp. hypokalemia, hypomagnesemia) before starting. Monitor hemodynamics in those with marginal cardiac compensation. 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.
Sotylize Pharmacokinetics
See Literature
Sotylize Interactions
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.
Sotylize Adverse Reactions
Adverse Reactions
Fatigue, bradycardia, dizziness, headache, dyspnea, nausea, vomiting, diarrhea; QT prolongation, Torsade de Pointes, hypotension (monitor).
Sotylize Clinical Trials
See Literature
Sotylize Note
Not Applicable
Sotylize Patient Counseling
See Literature
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