Beta-Cardone
sotalol hydrochloride
Pharmacologic class: Beta-adrenergic blocker (nonselective)
Therapeutic class: Antiarrhythmic (classes II and III)
Pregnancy risk category B
FDA Box Warning
• To minimize risk of induced arrhythmia, patients starting or restarting drug should be placed for at least 3 days (on maintenance dosage) in facility that can provide cardiac resuscitation, continuous ECG monitoring, and creatinine clearance calculations.
• Drug also is indicated to treat documented life-threatening ventricular arrhythmias and marketed as Betapace. However, don't substitute Betapace for Betapace AF because of significant labeling differences.
Action
Blocks stimulation of cardiac beta1-adrenergic and pulmonary, vascular, and uterine beta2-adrenergic receptor sites. This action reduces cardiac output and blood pressure, depresses sinus heart rate, and prolongs refractory period in atria and ventricles.
Availability
Tablets: 80 mg, 120 mg, 160 mg, 240 mg
Tablets (Betapace AF): 80 mg, 120 mg, 160 mg
Indications and dosages
➣ Ventricular arrhythmias
Adults: 80 mg P.O. b.i.d. (Betapace); may increase dosage gradually. For maintenance, 160 to 320 mg/day in two to three divided doses; some patients may require 240 to 320 mg/day in divided doses. For refractory ventricular fibrillation, may increase to 480 to 640 mg/day in divided doses.
➣ Atrial fibrillation or atrial flutter
Adults: 80 mg P.O. b.i.d. (Betapace AF). With careful monitoring, may increase to 120 mg b.i.d. p.r.n., to a maximum of 160 P.O. b.i.d.
Dosage adjustment
• Renal impairment
Contraindications
• Hypersensitivity to drug
• Uncontrolled heart failure
• Bronchial asthma, chronic obstructive pulmonary disease
• Congenital or acquired long-QT syndrome
• Sinus bradycardia, second- or third-degree atrioventricular (AV) block (unless patient has pacemaker)
• Sick sinus syndrome
• Cardiogenic shock
• Hypokalemia
• Creatinine clearance below 40 ml/minute
Precautions
Use cautiously in:
• renal or hepatic impairment, diabetes mellitus, hyperthyroidism, patients undergoing major surgery
• history of severe allergic reactions
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).
Administration
• Give 1 hour before or 2 hours after meals or antacids.
• Keep in mind that Betapace and Betapace AF have different indications and are not interchangeable or therapeutically equivalent.
Adverse reactions
CNS: fatigue, weakness, anxiety, dizziness, drowsiness, insomnia, memory loss, depression, mental status changes, nervousness, paresthesia, nightmares
CV: orthostatic hypotension, peripheral vasoconstriction, bradycardia, arrhythmias, heart failure, AV block
EENT: blurred vision, dry eyes, nasal stuffiness
GI: nausea, constipation, diarrhea
GU: erectile dysfunction, decreased libido
Metabolic: hyperglycemia, hypoglycemia
Musculoskeletal: joint pain, back pain, muscle cramps
Respiratory: wheezing, bronchospasm
Skin: itching, rash
Other: lupus syndrome, hypersensitivity reaction
Interactions
Drug-drug. Amphetamines, ephedrine, epinephrine, norepinephrine, phenylephrine, pseudoephedrine: unopposed alpha-adrenergic stimulation, causing excessive hypotension and bradycardia
Beta-adrenergic bronchodilators, theophylline: decreased efficacy of these drugs
Calcium channel blockers: increased risk of adverse cardiovascular reactions
Class IA antiarrhythmics (such as amiodarone, quinidine): increased risk of arrhythmias
Clonidine: excessive rebound hypertension with clonidine withdrawal
Ergot alkaloids: peripheral ischemia or gangrene
General anesthestics, phenytoin (I.V.), verapamil: additive myocardial depression
Lidocaine: increased lidocaine blood level, resulting in toxicity
Sulfonylureas: increased hypoglycemic effect
Drug-diagnostic tests. Antinuclear antibody: increased titers
Blood urea nitrogen, glucose, lipoproteins, potassium, triglycerides, uric acid: increased levels
Drug-food. Any food: decreased drug absorption
Patient monitoring
• Monitor ECG, electrolyte levels, and vital signs closely for first 3 days of therapy.
• Assess patient closely for signs and symptoms of heart failure.
• In long-term use, watch for signs and symptoms of drug-induced lupus syndrome.
Patient teaching
• Tell patient drug may cause significant cardiac effects. Explain need for ECG monitoring during first few days of therapy.
See Teach patient to recognize and immediately report signs and symptoms of heart failure and electrolyte imbalances.
• Inform patient that drug can cause serious interactions with many common drugs. Instruct him to tell all prescribers he's taking it.
See Teach patient to recognize and promptly report signs and symptoms of drug-induced lupus syndrome.
• Advise patient that drug may cause CNS effects that increase his injury risk. Encourage him to use appropriate safety precautions.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.