Generic
Sotalol Hydrochloride
1 brands available in the market
At a glance
Sotalol Hydrochloride is a non-cardioselective beta-blocker and Class III antiarrhythmic used for the treatment of serious arrhythmias such as ventricular tachyarrhythmias and supraventricular tachycardia.
Description
Sotalol is a non-cardioselective beta-blocker that increases sinus cycle length, slows heart rate, decreases AV nodal conduction, and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. As a Class III antiarrhythmic, it controls arrhythmias by prolonging cardiac action potentials.
Indications
- Life-threatening ventricular tachyarrhythmias
- Symptomatic non-sustained ventricular tachyarrhythmias
- Paroxysmal atrial tachycardia or fibrillation
- Paroxysmal AV re-entrant tachycardias
- Maintenance of sinus rhythm after cardioversion
Therapeutic class
Anti-adrenergic (Beta-blockers)
Pharmacological class
Non-cardioselective Beta-blocker & Class III Antiarrhythmic
Pharmacology
Sotalol blocks beta-1 receptors in the sinus node to reduce heart rate and slows AV nodal conduction. It prolongs cardiac action potential phase 3 (by blocking potassium channels), increasing refractory periods and preventing re-entry arrhythmias.
Mechanism of action
Slows heart rate and prolongs cardiac refractory periods to control arrhythmias.
Dosage
Adult Dose (Oral):
- Starting: 80 mg/day (single or 2 divided doses); increase gradually every 2-3 days
- Usual dose: 160-320 mg/day in 2 divided doses
- Life-threatening ventricular arrhythmias: Start 80 mg twice daily; increase every 3 days; max 480-640 mg/day
- Dose adjustment in renal impairment
Administration
- Take orally with or without food
- Swallow tablet whole; do not chew, crush, or break
- Take at the same time each day
- Avoid milk and dairy products
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Dizziness
- Fatigue
- Slow heart rate (bradycardia)
- Breathlessness
- Weakness
- Nausea, vomiting, taste change, diarrhea
Precautions & warnings
- Do not use in bronchial asthma or history of COPD
- Do not use in sick sinus syndrome, sinus bradycardia, 2nd/3rd degree AV block
- Do not use in uncontrolled heart failure, cardiogenic shock, hypotension
- Do not use in severe renal impairment (CrCl <10)
- Caution in pregnancy and lactation
Contraindications
- Bronchial asthma or history of COPD
- Sick sinus syndrome
- Sinus bradycardia, cardiogenic shock
- 2nd and 3rd degree AV block
- Uncontrolled cardiac failure, hypotension
- Severe peripheral arterial disease, renal impairment (CrCl <10)
- Congenital or acquired long QT syndromes
Drug interactions
- Digoxin: Increased risk of bradycardia
- Diuretics: Increased risk of arrhythmias
- Clonidine: Potentiates rebound HTN
- Class I antiarrhythmics, amiodarone: Prolonged refractoriness
- TCAs, phenothiazines, terfenadine: QT prolongation
- Verapamil/diltiazem: Additive effect on AV conduction and ventricular function (potentially fatal)
Food interactions
Alcohol is unsafe with Sotalol Hydrochloride; consult your doctor.
Use in pregnancy
Use in Pregnancy: Generally safe; animal studies show low or no adverse effects; limited human data; consult your doctor.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe; limited data suggests drug may pass into breast milk and harm the baby; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Caution required in elderly patients
Renal / hepatic impairment
Renal Impairment: CrCl 30-60: half dose; CrCl 10-30: quarter dose; CrCl <10: do not use; consult your doctor.
Hepatic Impairment: Safe in liver disease; no dose adjustment needed; consult your doctor.
Overdose effects
Overdose: Excessive bradycardia, hypotension, congestive heart failure, bronchospasm, hypoglycemia; symptomatic treatment, atropine, glucagon, β-agonists, pacing.
Storage conditions
Store in a cool and dry place, protected from light; keep out of reach of children.
Chemical structure
Sotalol Hydrochloride