HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SOTYLIZE™ safely and effectively. See full prescribing information for SOTYLIZE.
SOTYLIZE (sotalol hydrochloride) oral solution
Initial U.S. Approval: 1992
WARNING: LIFE-THREATENING PROARRHYTHMIA
See full prescribing information for complete boxed warning.
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Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation
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Do not initiate sotalol therapy if the baseline QTc is longer than 450 ms. If the QT interval prolongs to 500 ms or greater, the dose must be reduced, the interval between doses prolonged, or the drug discontinued.
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Patient should be hospitalized in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring
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Adjust the dosing interval based on creatinine clearance
INDICATIONS AND USAGE
SOTYLIZE is an antiarrhythmic indicated for:
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The treatment of life-threatening ventricular arrhythmias (1.1)
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The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) (1.2)
DOSAGE AND ADMINISTRATION
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If creatinine clearance is between 60 and 40 mL/min, administer once daily, if less than 40 mL/min, sotalol is not recommended (2.1)
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Ventricular Arrhythmia: Initiate therapy at 80 mg. Increase the dose as needed in increments of 80 mg, every 3 days to a maximum 320 mg (2.2)
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Symptomatic AFIB/AFL: Initiate therapy at 80 mg. Increase the dose as needed in increments of 40 mg, every 3 days to a maximum 160 mg (2.3)
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Pediatrics: Dosage depends on age (2.2)
DOSAGE FORMS AND STRENGTHS
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5 mg/mL oral solution (3)
CONTRAINDICATIONS
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Sinus bradycardia (<50 bpm), sick sinus syndrome or 2nd or 3rd degree AV block unless a functioning pacemaker is present (4)
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Congenital or acquired long QT syndromes, QT interval >450 ms (4)
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Cardiogenic shock, uncontrolled heart failure (4)
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Creatinine clearance <40 mL/min (4)
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Serum potassium <4 meq/L (4)
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Bronchial asthma or related bronchospastic conditions (4)
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Hypersensitivity to sotalol (4
WARNINGS AND PRECAUTIONS
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QT prolongation, bradycardia, AV block, hypotension, worsening heart failure: Reduce dose as needed (5.1, 5.2, 5.3, 5.4, 5.5)
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Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue (5.6)
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Correct any electrolyte disturbances (5.7)
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May mask symptoms of hypoglycemia or worsen hyperglycemia in diabetic patients; monitor (5.10)
Most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, bradycardia, dizziness, and headache (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Arbor Pharmaceuticals, LLC at 1-866-516-4950 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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