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Sotalol Hcl Injection Generic Name & Formulations
Legal Class
Rx
General Description
Sotalol HCl 15mg/mL; soln for IV infusion after dilution.
Pharmacological Class
Class II and III antiarrhythmic.
How Supplied
Single-dose vial (10mL)—1
Manufacturer
Sotalol Hcl Injection Indications
Indications
Maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation/atrial flutter (AFIB/AFL) who are currently in sinus rhythm. Life-threatening ventricular arrhythmia.
Sotalol Hcl Injection Dosage and Administration
Adult
May substitute for oral sotalol in those unable to take oral drugs or to achieve steady state concentration faster. For oral substitution: use same dosing frequency as oral sotalol and infuse IV over 5hrs. Oral dose 80mg: infuse IV 75mg; oral dose 120mg: infuse IV 112.5mg; oral dose 160mg: infuse IV 150mg. For loading dose: initiate and uptitrate in a facility with appropriate monitoring. Infuse over 1hr. Monitor QTc interval every 15mins during infusion. Continue to monitor QTc around Tmax after 1st (all patients) and 2nd oral dose (patients with CrCl ≥60mL/min). Based IV loading dose on target oral dose and CrCl: see full labeling.
Children
See full labeling. Starting doses: 3 days: 0.32mg/kg. 6 days: 0.51mg/kg. 9 days: 0.69mg/kg. 12 days: 0.81mg/kg. 2 weeks: 0.90mg/kg. 3 weeks: 1mg/kg. 1mo–6yrs: 1.2mg/kg. 6–12yrs: 1.1mg/kg. >12yrs: 0.95mg/kg. Renal impairment: initiate at lower dose and titrate less frequently.
Sotalol Hcl Injection Contraindications
Contraindications
Sinus bradycardia. Sick sinus syndrome. 2nd or 3rd degree AV block, unless paced. Long QT syndromes. QT interval >450msec. Cardiogenic shock. Decompensated heart failure. Serum potassium (<4mEq/L). Bronchial asthma or related bronchospastic conditions.
Sotalol Hcl Injection Boxed Warnings
Boxed Warning
Life-threatening proarrhythmia.
Sotalol Hcl Injection Warnings/Precautions
Warnings/Precautions
Increased arrhythmia risk in females, reduced CrCl, higher doses, bradycardia, history of sustained ventricular tachycardia/flutter, atrial fibrillation with sinus node dysfunction, heart failure, electrolyte disorders. Correct electrolyte imbalances (esp. hypokalemia, hypomagnesemia) and withdraw other antiarrhythmics prior to initiation. If QTc interval ≥500msec; reduce dose, lengthen the dosing interval, or discontinue therapy. Monitor hemodynamics in those with marginal cardiac compensation. Discontinue if symptoms of heart failure occurs. Bronchospastic disease. Diabetes. Acid-base imbalance. Hyperthyroidism. History of anaphylaxis. Surgery. Avoid abrupt cessation. Neonates. Labor & delivery: monitor. Pregnancy. Nursing mothers: not recommended.
Sotalol Hcl Injection Pharmacokinetics
See Literature
Sotalol Hcl Injection Interactions
Interactions
Avoid concomitant other drugs known to prolong QT interval. Increased risk of bradycardia or hypotension with negative chronotropes (eg, digitalis glycosides, diltiazem, verapamil, β-blockers); monitor ECG. Hypotension, marked bradycardia with reserpine, guanethidine, other catecholamine-depleting drugs. Increased rebound hypertension when withdrawing clonidine. Diuretics (monitor electrolytes). Antagonizes β-agonists (eg, albuterol, terbutaline, isoproterenol). Monitor antidiabetic agents. May block epinephrine. May result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.
Sotalol Hcl Injection Adverse Reactions
Adverse Reactions
Bradycardia, dyspnea, fatigue, QTc prolongation; hypotension, erectile dysfunction.
Sotalol Hcl Injection Clinical Trials
See Literature
Sotalol Hcl Injection Note
Not Applicable
Sotalol Hcl Injection Patient Counseling
See Literature
