SOTYLIZE (sotalol hydrochloride)

The pharmacokinetics of the d- and l-enantiomers of sotalol are essentially identical.

AbsorptionIn healthy subjects, the oral bioavailability of sotalol is 90 to100%. After oral administration, peak plasma concentrations are reached in 2.5 to 4 hours, and steady-state plasma concentrations are attained within 2 to3 days (that is, after 5-6 doses when administered twice daily). Over the oral dosage range 160 to640 mg/day, sotalol displays dose proportionality with respect to plasma concentratio...

14.1 Ventricular Arrhythmias In patients with life-threatening arrhythmias [sustained ventricular tachycardia/fibrillation (VT/VF)], sotalol was studied acutely [by suppression of programmed electrical stimulation (PES) induced VT and by suppression of Holter monitor evidence of sustained VT] and, in acute responders, chronically. In a double-blind, randomized comparison of sotalol and procainamide in 104 patients given intravenously (total of 2 mg/kg sotalol vs. 19 mg/kg of procainamide over 90 minutes), sotalol suppressed PES induction in 30% of patients vs. 20% for procainamide (p=0.2). In ...

Most common adverse reactions (≥2%) for SOTYLIZE are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly co...

For the treatment of AFIB/AFL or ventricular arrhythmias, SOTYLIZE is contraindicated in patients with: Baseline QT interval ˃450 msec Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronch...

QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose as needed ( 5.1 ) Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue ( 5.5 ) Correct any electrolyte disturbances ( 5.5 ) May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.7 ) 5.1 QT Prolongation and Proarrhythmia SOTYLIZE can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Point...

7 DRUG INTERACTIONS Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use ( 7.1 ) Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure ( 7.2 ) Dosage of insulin or antidiabetic drugs may need adjustment ( 7.4 ) Aluminum or magnesium-based antacids reduce sotalol exposure ( 7.7 ) 7.1 Antiarrhythmics and Other QT Prol...