Sotalol

Sotalol is a prescription drug indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT).

• Sotalol is available under the following different brand names: Betapace, Betapace AF, Sorine, and Sotylize.

Adult and Pediatric Dosages:

Tablet

• 80 mg
• 120 mg
• 160 mg
• 240 mg

Oral solution

• 5 mg/ml

Injectable solution

• 15 mg/ml

Dosing Considerations – Should be Given as Follows:

Ventricular and Supraventricular Arrhythmias

• Betapace or Sorine: 80 mg orally every 12 hours initially; increased as needed to 120-160 mg every 12 hours (2-3 days between increments)
• Intravenous (substitute for oral): 75 mg over 5 hours every 12 hours initially; adjusted if necessary (on basis of monitoring of clinical efficacy, quarterly interval, and adverse effects) every 3 days; not to exceed 150 mg every 12 hours

Supraventricular Tachycardia

Pediatric

• Children under 2 years old: reduce dose; see manufacturer's package insert for details
• Children 2 years and older: 30 mg/m2 orally every 8 hours initially; may be titrated up to 180 mg/m2/day orally

Refractory Life-Threatening Ventricular Arrhythmias

• Betapace or Sorine: 80 mg orally every 12 hours initially; increased as needed to 120-160 mg every 12 hours (2-3 days between increments) to 160-320 mg/day divided every 8-12 hours; up to 480-640 mg/day may be required if benefits outweigh increased adverse effects

Atrial Fibrillation/Flutter

• 75 mg intravenously over 5 hours every 12 hours initially; adjusted if necessary every 3 days; not to exceed 150 mg intravenously every 12 hours
• Betapace AF: 80 mg orally every 12 hours; increased as needed to 120-160 mg every 12 hours

Dosing modification

Renal impairment in Atrial Fibrillation/Flutter (Betapace AF)

• Creatinine Clearance greater than 60 ml/min: give every 12 hours
• Creatinine Clearance of 40-60 ml/min: give once daily
• Creatinine Clearance under 40 ml/min: contraindicated

Renal impairment in Ventricular Arrhythmia (Betapace, Sorine)

• Creatinine Clearance greater than 60 ml/min: give every 12 hours
• Creatinine Clearance of 30-59 ml/min: give once daily
• Creatinine Clearance of 10-29 ml/min: give every 36-48 hours
• Creatinine Clearance under 10 ml/min: individualize dosing

Common Side effects of Sotalol include:

• serious difficulty breathing
• dizziness
• fatigue
• slow heart rate
• chest pain
• strong, irregular heartbeat
• weakness
• lightheadedness
• nausea
• vomiting
• swelling
• headache
• sleep disturbances
• abnormal ECG
• diarrhea
• extremity pain
• low blood pressure
• mental confusion
• congestive heart failure
• itching
• rash
• fainting
• anxiety
• depression
• torsades de pointes or new ventricular tachycardia/fibrillation in patients with supraventricular arrhythmia
• torsades de pointes with a history of sustained ventricular tachycardia
• peripheral vascular disorders
• impotence
• proarrhythmic effectcatechol hypersensitivity after abrupt withdrawal
• increased insulin requirement in diabetics

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sotalol has severe interactions with at least 56 different drugs.
• Sotalol has serious interactions with at least 65 different drugs.
• Sotalol has moderate interactions with at least 189 different drugs.
• Sotalol has mild interactions with at least 34 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• Hospitalize patient at least 3 days while on maintenance dose in a facility that provides cardiac resuscitation, continuous ECG monitoring, and estimated creatinine clearance
• Calculate creatinine clearance before initiating sotalol therapy
• Sotalol has proarrhythmic effects and can cause life-threatening ventricular tachycardia associated with quarterly interval prolongation; reduce dose, prolong infusion time, or discontinue use if QTc is greater than 500 msec during therapy
• Do not substitute sotalol for sotalol AF, because of significant differences in labeling (patient package insert, dosing administration, safety information)
• Betapace AF was indicated for atrial fibrillation; Betapace indicated for ventricular arrhythmias
• This medication contains sotalol
• Do not take Betaspace, Betaspace AF, Sorine, or Sotylize if you are allergic to sotalol or any ingredients contained in this drug
• Keep out of reach of children
• In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Asthma, sinus bradycardia, sick sinus syndrome or 2°/3° atrioventricular block unless pacemaker in place
• Prolonged quarter syndromes, cardiogenic shock, uncontrolled congestive heart failure, hypersensitivity, hypokalemia (under 4 mEq/L), and hypomagnesemia
• Betapace AF and intravenously: creatinine clearance under 40 mL/min
• Easily reversible atrial fibrillation/flutter
• Quarterly interval greater than 450 ms when treating for atrial fibrillation (AFIB)

Effects of Drug Abuse

• Catechol hypersensitivity after abrupt withdrawal

Short-Term Effects

• See "What Are Side Effects Associated with Using Sotalol?"

Long-Term Effects

• Risk of osteoporosis, myopathy, delayed wound healing
• See "What Are Side Effects Associated with Using Sotalol?"

Cautions

• May worsen arrhythmias
• May cause or worsen congestive heart failure
• Long-term administration of beta-blockers should not be routinely discontinued before major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures
• Formulations indicated for ventricular and atrial arrhythmias are different (Betapace versus Betapace AF); follow instructions as applicable
• Antacids given 2 hours or less before sotalol may reduce the bioavailability
• Reduce or discontinue therapy if quarterly prolongation, slow heart rate (bradycardia), atrioventricular block, low blood pressure (hypotension), worsening of heart failure occur
• Do not discontinue abruptly; acute exacerbation of coronary artery disease may occur upon abrupt cessation of therapy
• Correct any electrolyte disturbances
• May mask symptoms of low blood sugar (hypoglycemia) or worsen high blood sugar (hyperglycemia) in diabetic patients; monitor

Pregnancy and Lactation

• Sotalol use during pregnancy may be acceptable
• Either animal studies show no risk but human studies are not available or animal studies showed minor risks and human studies were done and showed no risk
• Sotalol is present in breast milk; do not breastfeed while taking this drug