SOTYLIZE Dosage & Rx Info | Uses, Side Effects

Sotylize Generic Name & Formulations

Legal Class

General Description

Sotalol HCl 5mg/mL; oral soln; grape flavor.

Pharmacological Class

Class II and III antiarrhythmic.

How Supplied

Soln—250mL, 480mL

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

Manufacturer

Azurity Pharmaceuticals

Generic Availability

Mechanism of Action

Sotalol has both beta-adrenoreceptor blocking and cardiac action potential duration prolongation antiarrhythmic properties. Sotalol HCl is a racemic mixture of two isomers, both of which have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity.

Sotylize Indications

Indications

Documented life-threatening ventricular arrhythmias (eg, sustained ventricular tachycardia). Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation or atrial flutter (AFIB/AFL) who are currently in sinus rhythm.

Limitations of Use

Not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. Reserve its use for those in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reserved (eg, by Valsalva maneuver) should usually not be given Sotylize.

Sotylize Dosage and Administration

Adult

Initiate only in appropriate clinical setting that can provide cardiac resuscitation, continuous ECG, and creatinine clearance monitoring. Perform baseline ECG and calculate creatinine clearance. Ventricular arrhythmia (if QT <450msec and CrCl >60mL/min): initially 80mg twice daily. May increase in increments of 80mg/day every 3 days as needed, provided QT <500msec. Usual range 160–320mg/day, given in 2 or 3 divided doses (refractory patients may need 480–640mg once or twice daily). AFIB/AFL (if QT <450msec and CrCl >60mL/min): initially 80mg twice daily. May increase in increments of 80mg/day every 3 days as needed, provided QT <500msec. Usually 120mg twice daily. Both: renal impairment (CrCl <60mL/min): see full labeling.

Children

Initiate only in appropriate clinical setting that can provide cardiac resuscitation, continuous ECG, and creatinine clearance monitoring. Perform baseline ECG and calculate creatinine clearance. <2yrs: see full labeling for dose reductions. ≥2yrs: initially 1.2mg/kg three times daily (3.6mg/kg/day). Titrate up to max 2.4mg/kg three times daily; adjust based on clinical response, heart rate, and QTc. Allow at least 36hrs between dose increments to attain steady-state concentration.

Sotylize Contraindications

Contraindications

Baseline QT interval >450msec. Sinus bradycardia. Sick sinus syndrome. 2^nd or 3^rd degree AV block, unless paced. Congenital or acquired long QT syndromes. Cardiogenic shock. Decompensated heart failure. Serum potassium (<4mEq/L). Bronchial asthma or related bronchospastic conditions.

Sotylize Boxed Warnings

Boxed Warning

Life-threatening proarrhythmia.

Sotylize Warnings/Precautions

Not Applicable

Sotylize Pharmacokinetics

Absorption

Oral bioavailability: 90–100%. Peak plasma concentrations are reached in 2.5–4 hours; steady-state concentrations are attained within 2–3 days.

Elimination

Renal. Half-life: 12 hours.

Sotylize Interactions

Interactions

Class IA antiarrhythmics (eg, disopyramide, quinidine, procainamide), Class III antiarrhythmics (eg, amiodarone), or other drugs that prolong QT interval: not recommended. Discontinue Class I and III antiarrhythmics for at least 3 half-lives before starting. Increased risk of bradycardia or hypotension with negative chronotropes (eg, digitalis glycosides, diltiazem, verapamil, β-blockers). Hypotension, bradycardia with reserpine, guanethidine, other catecholamine-depleting drugs. Increased rebound hypertension when withdrawing clonidine. Diuretics (monitor electrolytes). Antagonizes albuterol, terbutaline, isoproterenol, other β-agonists. Monitor antidiabetic agents. May block epinephrine. Avoid within 2 hours of aluminum- or magnesium-containing antacids. May result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods.

Sotylize Adverse Reactions

Adverse Reactions

Fatigue, bradycardia, dyspnea, proarrhythmia, asthenia, dizziness, headache, nausea, vomiting, diarrhea; QT prolongation, Torsade de Pointes, hypotension (monitor).

Sotylize Clinical Trials

See Literature

Sotylize Note