Generic Name

Sotalol Hydrochloride

---

Classification

FDA Approved Indications

• Treatment of ventricular arrhythmias (including life-threatening ventricular arrhythmias)
• Maintenance of normal sinus rhythm in atrial fibrillation or flutter

Mechanism of Action

Sotalol has non-selective beta-adrenergic blocking properties and exhibits class III antiarrhythmic activity by prolonging the cardiac action potential duration and refractory period, thus reducing abnormal electrical activity in the heart.

Dosage and Administration

Adult: Initial: 80-160 mg twice daily; doses may be titrated based on response and tolerability.

Pediatric: Not typically used in pediatric population due to lack of extensive safety data.

Geriatric: Start at lower doses due to increased sensitivity and slower metabolism; monitor closely.

Renal Impairment: Adjust dose based on renal function; contraindicated in severe renal impairment (creatinine clearance <40 mL/min).

Hepatic Impairment: Use with caution; no specific dosage adjustments established.

Pharmacokinetics

Absorption: Well absorbed orally, with bioavailability of approximately 90%.

Distribution: Widely distributed; crosses the placenta, small amounts in breast milk.

Metabolism: Minimal hepatic metabolism; primarily excreted unchanged in urine.

Excretion: Renal excretion (primarily unchanged).

Half Life: About 12 hours in individuals with normal renal function; prolongs with renal impairment.

Contraindications

• Severe bradycardia
• AV block (second or third degree) without pacemaker
• Untreated congestive heart failure
• Hypersensitivity to sotalol

Precautions

• Renal impairment
• History of bronchospasm or asthma
• Electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia)
• Diabetes (may mask hypoglycemia symptoms)

Adverse Reactions - Common

• Fatigue (Common)
• Dizziness or lightheadedness (Common)
• Bradycardia (Common)
• Dyspnea or bronchospasm (Common)

Adverse Reactions - Serious

• Prolonged QT interval / Torsades de Pointes (Serious)
• Heart failure exacerbation (Serious)
• Severe arrhythmias including ventricular tachycardia or fibrillation (Serious)

Drug-Drug Interactions

• Other QT-prolonging agents (e.g., amiodarone, macrolides, fluoroquinolones)
• Calcium channel blockers (diltiazem, verapamil)
• Other beta-blockers

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed.
• Do not discontinue abruptly to avoid rebound arrhythmias.
• Report signs of dizziness, fainting, or shortness of breath.
• Avoid activities requiring alertness if experiencing side effects.
• Limit intake of potassium and magnesium-rich foods to prevent electrolyte imbalances.

Special Considerations

Black Box Warnings:

• Arrhythmias, including torsades de pointes, may occur, especially with QT prolongation.
• Use with caution in patients with impaired renal function.

Genetic Factors: Genetic variations may affect drug metabolism and response.

Lab Test Interference: May interfere with serum glucose and thyroid function tests.

Overdose Management

Signs/Symptoms: Severe bradycardia, hypotension, heart failure, arrhythmias including torsades de pointes.

Treatment: Discontinue sotalol immediately. Supportive care; may include intravenous atropine for bradycardia, magnesium sulfate for torsades, temporary pacing, or vasopressors for hypotension.

Storage and Handling

Storage: Store at controlled room temperature (68-77°F, 20-25°C).

Stability: Stable in original container for specified shelf life; avoid moisture and direct sunlight.