Sotalex

• Life-threatening Ventricular Arrhythmias:
  Treatment and prevention of documented ventricular arrhythmias, including sustained ventricular tachycardia and ventricular fibrillation.
• Supraventricular Arrhythmias:
  Maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation or atrial flutter after conversion to sinus rhythm.
• Off-label Uses:
  Used occasionally for other arrhythmias under specialist guidance.

• Adults:
  Initial dose usually 80 mg orally twice daily.
  Dosage is adjusted based on clinical response and ECG findings, with typical maintenance doses ranging from 80 mg to 160 mg twice daily.
  Maximum dose generally not to exceed 640 mg per day divided into two doses.
• Route:
  Oral administration with or without food. Tablets should be swallowed whole.
• Special Populations:
• Renal impairment: Dose adjustment required according to creatinine clearance; contraindicated in severe impairment.
• Elderly: Start at lower doses with close monitoring due to increased sensitivity.
• Pediatric: Safety and efficacy not established.
• Duration:
  Long-term therapy for arrhythmia control, individualized per patient.

Sotalol hydrochloride is a non-selective beta-adrenergic blocker (Class II antiarrhythmic) with additional Class III antiarrhythmic activity. It inhibits beta-1 and beta-2 adrenergic receptors, reducing sympathetic stimulation of the heart, thereby decreasing heart rate, myocardial contractility, and conduction velocity. Concurrently, it blocks potassium channels responsible for cardiac repolarization, prolonging the action potential duration and refractory period. This dual action helps suppress abnormal electrical impulses and prevents reentrant arrhythmias, stabilizing the cardiac rhythm.

• Absorption: Well absorbed orally with about 90% bioavailability; peak plasma levels reached within 2 to 4 hours.
• Distribution: Volume of distribution approximately 2.7 L/kg; plasma protein binding about 30%.
• Metabolism: Minimal hepatic metabolism.
• Half-life: Approximately 12 hours in normal renal function; prolonged in renal impairment.
• Excretion: Primarily excreted unchanged by the kidneys (~60-70%).

• Pregnancy: FDA category B. Animal studies show no teratogenic effects; however, well-controlled human studies are lacking. Use only if clearly needed.
• Lactation: Excreted in breast milk; caution advised when administered to breastfeeding mothers.

• Primary Class: Antiarrhythmic agent
• Subclass: Class II (beta-blocker) and Class III (potassium channel blocker)

• Hypersensitivity to sotalol or any excipients
• Congenital or acquired long QT syndrome
• Second- or third-degree atrioventricular block without pacemaker
• Sinus bradycardia (<50 bpm)
• Cardiogenic shock
• Severe bronchial asthma or COPD
• Uncontrolled heart failure
• Bradycardia-associated syncope

• Risk of life-threatening arrhythmias including torsades de pointes; ECG monitoring mandatory.
• Adjust dose or avoid use in renal impairment due to drug accumulation.
• Use cautiously in heart failure patients; may worsen symptoms.
• Monitor for bronchospasm in patients with reactive airway disease.
• Hypoglycemia signs may be masked in diabetic patients.
• Correct electrolyte imbalances before and during treatment.
• Regular monitoring of ECG, renal function, and electrolytes is recommended.

• Common: Fatigue, dizziness, bradycardia, hypotension, headache, dyspnea
• Serious: Torsades de pointes, heart block, exacerbation of heart failure, bronchospasm, hypoglycemia masking, hypersensitivity reactions

• Additive effects with other QT-prolonging agents (e.g., amiodarone, certain antibiotics).
• Interaction with calcium channel blockers (verapamil, diltiazem) may increase bradycardia risk.
• Digoxin levels may increase; monitor for toxicity.
• Beta-agonist effects may be antagonized.
• Diuretics can alter electrolytes, increasing arrhythmia risk.

• Current guidelines recommend sotalol for select arrhythmias with caution due to proarrhythmia risk.
• FDA warnings emphasize careful dosing and monitoring to prevent torsades de pointes.
• Renal function assessment is critical prior to initiation and during therapy.

• Store tablets at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in original container, tightly closed.
• Do not freeze.
• Keep out of reach of children.