CHF and arrhythmias:

Indications for: Sotalol HCl Injection

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.

Adult Dosage:

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 Dosage:

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:

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.

Boxed Warning:

Life-threatening proarrhythmia.

Sotalol HCl Injection 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 Classification:

Class II and III antiarrhythmic.

Sotalol HCl Injection 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.

Adverse Reactions:

Bradycardia, dyspnea, fatigue, QTc prolongation; hypotension, erectile dysfunction.

How Supplied:

Single-dose vial (10mL)—1