Navigation

Sotalol

Brand Name: Betapace, Betapace AF, Sorine, Sotylize

Generic Name: Sotalol

Drug Class: Antidysrhythmics, II; Antidysrhythmics, III; Beta-Blockers, Nonselective

What Is Sotalol and How Does It Work?

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

What Are Dosage of Sotalo?

Dosage of Sotalol:

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

What Are Side Effects Associated with Using Sotalol?

Common Side effects of Sotalol include:

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

What Other Drugs Interact with Sotalol?

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.

What Are Warnings and Precautions for Sotalol?

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

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

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