Sotalol hydrochloride for intravenous use is an antiarrhythmic agent indicated for:

• Substitution for oral sotalol in patients who are unable to take sotalol orally (1.1)

Oral sotalol is indicated for:

• Maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter (1.2)
• Treatment of documented life-threatening ventricular arrhythmias (1.3)

Intravenous sotalol must be diluted. Appropriate diluents are saline, 5% dextrose in water (D5W), or Ringer’s lactate. Intravenous sotalol is administered by a volumetric infusion pump over 5 hours at a constant infusion rate. See full prescribing information for general rules and safety measures (2.1), dose selection (2.2) and preparation of infusion (2.3) Maintenance of sotalol therapy – Replacement of Oral Dosing The intravenous dose is approximately equal to the oral dose and administered at the same dosing frequency. 75 mg of intravenous sotalol is approximately equal to 80 mg of oral sotalol (2.2) Initiation of Therapy

• Calculate creatinine clearance to determine dosing interval (2.1)
• Starting adult dose is 75 mg administered twice daily. If creatinine clearance is between 60 and 40 mL/min, administer once daily, if less than 40 mg/mL, sotalol is not recommended (2.1)
• The dose can be up-titrated to maximal dose of 150 mg twice daily under close ECG and QT interval monitoring (2.5, 2.6)

• 150 mg sotalol hydrochloride in 10 mL vial (15 mg/mL) (Must be diluted prior to use)

• Sinus bradycardia (<50 bpm), sick sinus syndrome or 2nd and 3rd degree AV block unless a functioning pacemaker is present (4)
• Congenital or acquired long QT syndromes, QT interval >450 ms (4)
• Cardiogenic shock, uncontrolled heart failure (4)
• Creatinine clearance <40 mL/min (4)
• Serum potassium <4 meq/L (4)
• Bronchial asthma or related bronchospastic conditions (4)
• Known hypersensitivity to sotalol (4)

• QT prolongation and proarrhythmia: Reduce dose, reduce rate of infusion, or discontinue (5.1)
• Bradycardia, AV block, hypotension, worsening heart failure: Reduce dose as needed (5.3, 5.4, 5.5. 5.6)
• Acute exacerbation of coronary artery disease upon cessation of therapy: Do not abruptly discontinue (5.8)
• Electrolyte disturbances must be corrected (5.9)
• Monitor serum glucose in diabetic patients as sotalol may mask symptoms of hypoglycemia, or worsen hyperglycemia (5.12)

Most common adverse reactions (>10%) seen with oral sotalol (dose related) are fatigue, dizziness, lightheadedness, headache, asthenia, nausea, dyspnea, bradycardia, chest pain, and palpitation (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Academic Pharmaceuticals, Inc. at 1-(847) 735-1170 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Digoxin increases the risk of proarrhythmic events (7.1)
• Calcium blocking drugs may have additive effects on decreasing atrioventricular conduction, ventricular function, and blood pressure (7.2)
• Concomitant use of catecholamine-depleting drugs may produce hypotension, marked bradycardia, and syncope (7.3)
• Dosage of insulin or antidiabetic drugs may require adjustment (hyperglycemia). Symptoms of hypoglycemia may be masked (7.4)
• Dose of beta-2 receptor agonists may have to be increased (7.5)
• Sotalol may potentiate the rebound hypertension after discontinuation of clonidine (7.6)

• Nursing mothers: Sotalol is excreted in milk in large amounts; potential harm to the infants. Discontinue nursing or discontinue the drug (8.3)