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Pronunciation

(SOE ta lole)

Index Terms

  • Sotalol HCl
  • Sotalol Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as hydrochloride:

Generic: 150 mg/10 mL (10 mL)

Solution, Oral, as hydrochloride:

Sotylize: 5 mg/mL (250 mL, 480 mL) [contains sodium benzoate; grape flavor]

Tablet, Oral, as hydrochloride:

Betapace: 80 mg, 120 mg, 160 mg [scored; contains fd&c blue #2 aluminum lake]

Betapace AF: 80 mg, 120 mg, 160 mg [scored]

Sorine: 80 mg, 120 mg, 160 mg, 240 mg [scored]

Generic: 80 mg, 120 mg, 160 mg, 240 mg

Brand Names: U.S.

  • Betapace
  • Betapace AF
  • Sorine
  • Sotylize

Pharmacologic Category

  • Antiarrhythmic Agent, Class II
  • Antiarrhythmic Agent, Class III
  • Beta-Adrenergic Blocker, Nonselective

Pharmacology

Beta-blocker which contains both beta-adrenoreceptor-blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) properties

Class II effects: Increased sinus cycle length, slowed heart rate, decreased AV nodal conduction, and increased AV nodal refractoriness Sotalol has both beta1- and beta2-receptor blocking activity. The beta-blocking effect of sotalol is a noncardioselective (half maximal at about 80 mg/day and maximal at doses of 320 to 640 mg/day). Significant beta-blockade occurs at oral doses as low as 25 mg/day.

Class III effects: Prolongation of the atrial and ventricular monophasic action potentials, and effective refractory prolongation of atrial muscle, ventricular muscle, and atrioventricular accessory pathways in both the antegrade and retrograde directions. Sotalol is a racemic mixture of d- and l-sotalol; both isomers have similar Class III antiarrhythmic effects while the l-isomer is responsible for virtually all of the beta-blocking activity. The Class III effects are seen only at oral doses ≥160 mg/day.

Absorption

Oral: Well absorbed (Hanyok 1993); decreased ~20% by meals compared with fasting

Distribution

Vd: 1.2 to 2.4 L/kg (Hanyok 1993)

Metabolism

None

Excretion

Urine (as unchanged drug)

Clearance (apparent) (Saul 2001b):

Neonates ≤1 month: 11 mL/minute

Infants and Children >1 month to 24 months: 32 mL/minute

Children >2 years to <7 years: 63 mL/minute

Children 7 to 12 years: 95 mL/minute

Onset of Action

Oral: Rapid; at 1 to 2 hours post dosing (steady-state), reductions in heart rate and cardiac index seen (Winters 1993)

IV: When administered IV over 5 minutes for ongoing VT, onset of action is ~5 to 10 minutes (Ho 1994)

Time to Peak

Serum: Oral: Infants and Children 3 days to 12 years: Mean range: 2 to 3 hours; Adults: 2.5 to 4 hours

Half-Life Elimination

Oral:

Neonates ≤1 month: 8.4 hours (Saul 2001b)

Infants and Children >1 month to 24 months: 7.4 hours (Saul 2001b)

Children >2 years to <7 years: 9.1 hours (Saul 2001b)

Children 7 to 12 years: 9.2 hours (Saul 2001b)

Adults: 12 hours

Adults with renal failure (anuric): Up to 69 hours

IV: Pharmacokinetics of the IV formulation (administered over 5 hours) are similar to the oral formulations (Somberg 2010).

Protein Binding

None

Special Populations: Renal Function Impairment

Terminal half-life increases with renal impairment.

Use: Labeled Indications

Betapace/Betapace AF, Sorine, Sotylize: Treatment of documented ventricular arrhythmias (ie, sustained ventricular tachycardia), that in the judgment of the health care provider are life-threatening

Betapace/Betapace AF, Sotylize: Maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter) in patients with symptomatic atrial fibrillation/atrial flutter who are currently in sinus rhythm. Manufacturer of Sorine states substitutions should not be made for sotalol AF due to significant differences in labeling (ie, patient package insert and safety information)

According to the American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS), sotalol is not effective for conversion of atrial fibrillation to sinus rhythm but may be used to prevent atrial fibrillation (AHA/ACC/HRS [January 2014])

Injection: Substitution for oral sotalol in those who are unable to take sotalol orally

Use: Unlabeled

Fetal tachycardia; alternative antiarrhythmic for the treatment of atrial fibrillation in patients with hypertrophic cardiomyopathy (HCM)

Contraindications

Hypersensitivity to sotalol or any component of the formulation; bronchial asthma or related bronchospastic conditions; sinus bradycardia (<50 bpm during waking hours [Betapace/Betapace AF, Sotylize, sotalol injection]); second- or third-degree AV block (unless a functioning pacemaker is present); congenital or acquired long QT syndromes; cardiogenic shock; uncontrolled heart failure

Additional contraindications:

Betapace/Betapace AF: When used for atrial fibrillation/flutter, either baseline QTc interval >450 msec or CrCl <40 mL/minute; serum potassium <4 mEq/L; sick sinus syndrome

Sotylize, sotalol injection: Baseline QTc interval >450 msec (or JT >330 msec if QRS >100 msec [sotalol injection]); CrCl <40 mL/minute; serum potassium <4 mEq/L; sick sinus syndrome

Documentation of allergenic cross-reactivity for beta-adrenergic blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Baseline QTc interval and creatinine clearance must be determined prior to initiation. If CrCl ≤60 mL/minute, dosing interval adjustment is necessary. Sotalol should be initiated and doses increased in a hospital for at least 3 days with facilities for cardiac rhythm monitoring and assessment. Proarrhythmic events can occur after initiation of therapy and with each upward dosage adjustment.

Atrial fibrillation/flutter (symptomatic):

IV: Substitution for oral sotalol: Note: The effects of the initial IV dose must be monitored and the dose titrated either upward or downward, if needed, based on clinical effect, QTc interval, or adverse reactions.

Initial dose: 75 mg infused over 5 hours twice daily

Dose adjustment: If the initial dose does not reduce the frequency of relapse and excessive QTc prolongation does not occur, may increase to 112.5 mg twice daily. If at steady state this dose still does not control arrhythmia and QTc prolongation does not occur, may further increase dose to 150 mg twice daily.

Dose range: Usual therapeutic dose: 112.5 mg twice daily; maximum dose: 150 mg twice daily

Conversion from oral sotalol to IV sotalol:

80 mg oral equivalent to 75 mg IV

120 mg oral equivalent to 112.5 mg IV

160 mg oral equivalent to 150 mg IV

Oral: Betapace/Betapace AF, Sotylize: Initial: 80 mg twice daily. If the initial dose does not reduce frequency of relapse and excessive QTc prolongation does not occur after 3 days, the dose may be increased to 120 mg twice daily; may further increase to a maximum dose of 160 mg twice daily if response is inadequate and QTc prolongation is not excessive.

Ventricular arrhythmias (Betapace/Betapace AF, Sorine, Sotylize):

IV: Substitution for oral sotalol: Note: The effects of the initial IV dose must be monitored and the dose titrated either upward or downward, if needed, based on clinical effect, QTc interval, or adverse reactions.

Initial dose: 75 mg infused over 5 hours twice daily

Dose adjustment: If the initial dose does not reduce the frequency of relapse and excessive QTc prolongation does not occur, may increase after at least 3 days to 112.5 mg twice daily. May further increase dose every 3 days in increments of 75 mg/day.

Dose range: Usual therapeutic dose: 75 to 150 mg twice daily; maximum dose: 300 mg twice daily.

Conversion from oral sotalol to IV sotalol:

80 mg oral equivalent to 75 mg IV

120 mg oral equivalent to 112.5 mg IV

160 mg oral equivalent to 150 mg IV

Oral:

Initial dose: 80 mg twice daily; dose may be increased (in increments of 80 mg/day [Betapace/Betapace AF, Sotylize]) gradually to 160 to 320 mg daily; allow 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow for monitoring of QT intervals

Usual range: Most patients respond to a total daily dose of 160 to 320 mg in 2 to 3 divided doses.

Some patients, with life-threatening refractory ventricular arrhythmias, may require total daily doses as high as 480 to 640 mg; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events.

Monomorphic VT (hemodynamically stable) (off-label use): IV: 1.5 mg/kg over 5 minutes (AHA [Neumar 2010]); Note: Clinical trial employed standard dose of 100 mg (Ho 1994).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Baseline QTc interval and creatinine clearance must be determined prior to initiation. If CrCl ≤60 mL/minute, dosing interval adjustment is necessary. Sotalol should be initiated and doses increased in a hospital for at least 3 days with facilities for cardiac rhythm monitoring and assessment. Proarrhythmic events can occur after initiation of therapy and with each upward dosage adjustment. Note: Dosing per manufacturer, based on pediatric pharmacokinetic data; wait at least 36 hours between dosage adjustments to allow monitoring of QTc intervals.

Atrial fibrillation/flutter (symptomatic): Oral: Betapace/Betapace AF, Sotylize:

Infants and Children ≤2 years: Dosage should be adjusted (decreased) by plotting of the child's age on a logarithmic scale; see graph or refer to manufacturer's package labeling.

Children >2 years and Adolescents: Initial: 30 mg/m2/dose every 8 hours; may increase gradually to a maximum of 60 mg/m2 every 8 hours, not to exceed adult dose (maximum adult dose: 320 mg/day)

Ventricular arrhythmias: Oral: Betapace/Betapace AF, Sorine, Sotylize:

Infants and Children ≤2 years: Dosage should be adjusted (decreased) by plotting of the child's age on a logarithmic scale; see graph or refer to manufacturer's package labeling.

Children >2 years and Adolescents: Initial: 30 mg/m2/dose every 8 hours; may increase gradually to a maximum of 60 mg/m2 every 8 hours, not to exceed adult dose (maximum adult dose: 320 mg/day)

Age factor nomogram

Dosing: Renal Impairment

Adults: Dose escalations in renal impairment should be done after administration of at least 5 to 6 doses at appropriate intervals.

CrCl >60 mL/minute: Administer every 12 hours.

CrCl 40 to 60 mL/minute: Administer every 24 hours.

CrCl <40 mL/minute: Use is contraindicated. Note: The manufacturer's labeling for some products (Betapace/Betapace AF, Sorine) recommend alternate dosing for patients with CrCl <40 mL/minute (refer to manufacturer's labeling).

Hemodialysis: Use is contraindicated in patients with CrCl <40 mL/minute. Note: The manufacturer's labeling for some products (Betapace/Betapace AF, Sorine) recommend extreme caution be employed if sotalol is used in patients with renal failure undergoing hemodialysis. Multiple cases of torsades de pointes have been reported when sotalol was used even at low dosages (eg, 80 mg daily) in patients with end-stage renal disease treated with hemodialysis (Huynh-Do 1996). Hemodialysis would be expected to reduce sotalol plasma concentrations because sotalol is not bound to plasma proteins and does not undergo extensive metabolism.

Peritoneal dialysis: Use is contraindicated in patients with CrCl <40 mL/minute. Cases of torsades de pointes have been reported when sotalol was used even at low dosages (eg, 80 mg daily) in patients with end-stage renal disease treated with peritoneal dialysis (Dancey 1997; Tang 1997).

Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer's labeling; dosing in children with renal impairment has not been investigated; use lower doses or increased dosing intervals; closely monitor clinical response, heart rate and QTc interval; allow adequate time between dosage increments to achieve new steady-state, since half-life will be prolonged with renal impairment.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely because sotalol is not metabolized by the liver.

Dosing: Adjustment for Toxicity

QTc ≥500 msec during initiation period:

Betapace/Betapace AF, Sotylize: Reduce dose, prolong the dosing interval (Sotylize), or discontinue sotalol

Sotalol injection: Reduce dose, prolong the infusion time by decreasing the infusion rate, or discontinue sotalol

QTc ≥520 msec (or JT interval ≥430 msec if the QRS >100 msec) during maintenance therapy (Betapace/Betapace AF, sotalol injection): Reduce dose and carefully monitor QTc until <520 msec. If QTc interval ≥520 msec on the lowest maintenance dose, discontinue sotalol.

QTc ≥550 msec (Betapace/Betapace AF, Sorine): Reduce dose or discontinue sotalol.

Reconstitution

To prepare sotalol infusion, see manufacturer’s prescribing information. Usually prepared in a volume of 100 to 250 mL; appropriate diluents are NS, D5W, or LR.

Extemporaneously Prepared

Note: Commercial oral solution is available (5 mg/mL)

A 5 mg/mL sotalol syrup may be made with Betapace, Sorine, or Betapace AF tablets and Simple Syrup containing sodium benzoate 0.1% (Syrup, NF). Place 120 mL Syrup, NF in a 6-ounce amber plastic (polyethylene terephthalate) prescription bottle; add five Betapace, Sorine, or Betapace AF 120 mg tablets and shake the bottle to wet the tablets. Allow tablets to hydrate for at least 2 hours, then shake intermittently over ≥2 hours until the tablets are completely disintegrated; a dispersion of fine particles (water-insoluble inactive ingredients) in syrup should be obtained. Note: To simplify the disintegration process, tablets can hydrate overnight; tablets may also be crushed, carefully transferred into the bottle and shaken well until a dispersion of fine particles in syrup is obtained. Label "shake well". Stable for 3 months at 15°C to 30°C (59°F to 86°F) and ambient humidity.

Betapace/Betapace AF prescribing information, Zug, Switzerland: Covis Pharmaceuticals; May 2016.Sorine prescribing information, Upsher-Smith, Minneapolis, MN, 2012.

Administration

Oral: Administer without regard to meals.

IV:

Substitution for oral: Administer over 5 hours; may prolong duration of infusion if QT interval prolongs to ≥500 msec.

Hemodynamically stable monomorphic VT: Administer IV push over 5 minutes; use with caution because of increased risk of adverse events (eg, bradycardia, hypotension, torsade de pointes) (ACLS 2010).

Compatibility

Stable in D5W, NS, or LR.

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). Protect injection from freezing and light.

Drug Interactions

Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

Alpha-/Beta-Agonists (Direct-Acting): Beta-Blockers may enhance the vasopressor effect of Alpha-/Beta-Agonists (Direct-Acting). Epinephrine used as a local anesthetic for dental procedures will not likely cause clinically relevant problems. Some beta-adrenoceptor mediated effects of Alpha-/Beta-Agonists (Direct-Acting), including anti-anaphylactic effects of epinephrine, may be diminished by Beta-Blockers. Management: Cardioselective beta-blockers and lower doses of epinephrine may confer a more limited risk. Patients who may require acute subcutaneous epinephrine (e.g., bee sting kits) should probably avoid beta blockers. Exceptions: Dipivefrin. Consider therapy modification

Alpha1-Blockers: Beta-Blockers may enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Monitor therapy

Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Exceptions: Apraclonidine. Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Anilidopiperidine Opioids: May enhance the bradycardic effect of Beta-Blockers. Anilidopiperidine Opioids may enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Antacids: May decrease the serum concentration of Sotalol. Management: Avoid simultaneous administration of sotalol and antacids. Administer antacids 2 hours after sotalol. Consider therapy modification

Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May decrease the serum concentration of Beta-Blockers. Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Beta2-Agonists: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Beta2-Agonists. Avoid combination

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bupivacaine: Beta-Blockers may increase the serum concentration of Bupivacaine. Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have also been reported. Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Beta-Blockers. Exceptions: Bepridil. Monitor therapy

Cardiac Glycosides: Beta-Blockers may enhance the bradycardic effect of Cardiac Glycosides. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Avoid combination

Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Management: Administer these agents in combination with caution, and monitor for conduction disturbances. Avoid methacholine with any beta blocker due to the potential for additive bronchoconstriction. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Ergot Derivatives: Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives. Exceptions: Nicergoline. Consider therapy modification

Fingolimod: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Avoid combination

Floctafenine: May enhance the adverse/toxic effect of Beta-Blockers. Avoid combination

Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Consider therapy modification

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Highest Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Highest Risk QTc-Prolonging Agents. Avoid combination

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Indapamide: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Consider therapy modification

Insulin: Beta-Blockers may enhance the hypoglycemic effect of Insulin. Monitor therapy

Ivabradine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lidocaine (Systemic): Beta-Blockers may increase the serum concentration of Lidocaine (Systemic). Monitor therapy

Lidocaine (Topical): Beta-Blockers may increase the serum concentration of Lidocaine (Topical). Monitor therapy

Lidocaine (Topical): May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Antiarrhythmic Agents (Class III) may increase the serum concentration of Lidocaine (Topical). This mechanism specifically applies to amiodarone and dronedarone. Monitor therapy

Mepivacaine: Beta-Blockers may increase the serum concentration of Mepivacaine. Monitor therapy

Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Avoid combination

Midodrine: Beta-Blockers may enhance the bradycardic effect of Midodrine. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Propafenone: May enhance the arrhythmogenic effect of Antiarrhythmic Agents (Class III). Management: Concurrent use of propafenone with quinidine, amiodarone, or other class IA or class III antiarrhythmics should be avoided. Treatment with such agents should be withheld for at least 5 half-lives prior to initiation of propafenone. Avoid combination

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Regorafenib: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

Reserpine: May enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of Beta-Blockers. Exceptions: Rifabutin. Monitor therapy

Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Avoid combination

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy

Sulfonylureas: Beta-Blockers may enhance the hypoglycemic effect of Sulfonylureas. Cardioselective beta-blockers (eg, acebutolol, atenolol, metoprolol, and penbutolol) may be safer than nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial symptom of hypoglycemia. Ophthalmic beta-blockers are probably associated with lower risk than systemic agents. Monitor therapy

Theophylline Derivatives: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Theophylline Derivatives. Consider therapy modification

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Vinflunine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Test Interactions

May falsely increase urinary metanephrine values when fluorimetric or photometric methods are used; does not interact with HPLC assay with solid phase extraction for determination of urinary catecholamines

Adverse Reactions

There is minimal clinical experience with IV sotalol; however, since exposure is similar between IV and oral sotalol, adverse reactions are expected to be similar.

>10%:

Cardiovascular: Bradycardia (dose related; 8% to 16%), chest pain (3% to 16%), palpitations (3% to 14%)

Central nervous system: Fatigue (dose related; 5% to 20%), dizziness (3% to 20%), headache (2% to 12%)

Neuromuscular & skeletal: Weakness (4% to 13%)

Respiratory: Dyspnea (dose related; 5% to 21%)

1% to 10%:

Cardiovascular: Edema (2% to 8%), ECG abnormality (2% to 7%), hypotension (3% to 6%), congestive heart failure (1% to 5%; incidence may be higher in patients with risk factors), syncope (1% to 5%), proarrhythmia (<1% to 5%), torsades de pointes (dose related; 1% to 4%), peripheral vascular disorder (1% to 3%), angina pectoris (2%), presyncope (1% to 2%), cardiovascular signs and symptoms (<1% to 2%), worsened ventricular tachycardia (1%), cerebrovascular accident (≤1%), hypertension (≤1%), vasodilation (≤1%), prolonged Q-T interval on ECG (dose related)

Central nervous system: Sleep disorder (1% to 8%), insomnia (3% to 4%), anxiety (2% to 4%), depression (1% to 4%), paresthesia (1% to 4%), sensation of cold (2% to 3%), impaired consciousness (1% to 3%), mood changes (≤1%)

Dermatologic: Hyperhidrosis (5%), skin rash (2% to 5%), diaphoresis (1% to 3%)

Endocrine & metabolic: Weight changes (1%)

Gastrointestinal: Nausea and vomiting (4% to 10%), diarrhea (2% to 7%), abdominal pain (<1% to 4%), dyspepsia (2% to 3%), abdominal distention (<1% to 3%), decreased appetite (2%), change in appetite (1% to 2%), colonic disease (1% to 2%), flatulence (<1% to 2%)

Genitourinary: Sexual disorder (≤3%), genitourinary complaint (≤1%)

Hematologic & oncologic: Hemorrhage (<1% to 2%)

Infection: Infection (1% to 2%), influenza (1% to 2%)

Local: Local pain (1% to 2%)

Neuromuscular & skeletal: Limb pain (2% to 7%), musculoskeletal pain (3% to 4%), musculoskeletal chest pain (2% to 3%), back pain (<1% to 3%)

Ophthalmic: Visual disturbance (1% to 5%)

Respiratory: Upper respiratory complaint (1% to 8%), pulmonary disease (3% to 5%), tracheobronchitis (1% to 3%), asthma (<1% to 2%)

Miscellaneous: Fever (1% to 3%), laboratory test abnormality (1% to 3%), AICD discharge (<1% to 2%)

<1% (Limited to important or life-threatening): Alopecia, eosinophilia, increased liver enzymes, leukopenia, paralysis, phlebitis, pruritus, pulmonary edema, skin photosensitivity, thrombocytopenia

ALERT: U.S. Boxed Warning

Life threatening proarrhythmia:

Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of induced arrhythmia, patients initiated or reinitiated on sotalol or sotalol AF and patients who are converted from IV to oral administration should be placed for a minimum of 3 days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic (ECG) monitoring. Do not initiate if baseline QTc interval is longer than 450 msec (Betapace/Betapace AF [when used for atrial fibrillation/atrial flutter], Sotylize, or sotalol injection). If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, prolong the duration of the infusion (injection) or discontinue the drug.

Renal impairment:

Calculate creatinine clearance (CrCl) prior to dosing; adjust dose based on CrCl.

Product interchange:

Do not substitute Sorine for sotalol AF because of significant differences in labeling (ie, patient package insert, dosing administration, safety information).

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

• Bradycardia/hypotension: May cause bradycardia (including heart block) and hypotension. Dose adjustments of agents that slow AV nodal conduction may be necessary when sotalol is initiated.

• Proarrhythmic effects: [US Boxed Warning]: Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation (ie, torsades de pointes). Do not initiate if baseline QTc interval is >450 msec (Betapace/Betapace AF, Sotylize, or sotalol injection). If QTc interval prolongs to 500 msec or exceeds 500 msec during therapy, reduce the dose, prolong the interval between doses, prolong the duration of the infusion (sotalol injection), or discontinue use (Betapace/Betapace AF, Sotylize, sotalol injection). Adjust the dosing interval based on creatinine clearance (CrCl). QTc prolongation is directly related to the concentration of sotalol; reduced CrCl, female gender, reduced heart rate, and large doses increase the risk of QTc prolongation and subsequent torsades de pointes. Patients initiated or reinitiated on sotalol or sotalol AF and patients who are converted from IV to oral administration should be placed for a minimum of 3 days (on their maintenance dose) in a facility that can provide cardiac resuscitation and continuous electrocardiographic (ECG) monitoring. Some experts will initiate oral therapy on an outpatient basis if the patient is in sinus rhythm provided the QT interval and serum potassium are normal and the patient is not receiving any other QT-interval prolonging medications but require inpatient hospitalization if the patient is in atrial fibrillation (AHA/ACC/HRS [January 2014]). Calculation of CrCl must occur prior to administration of the first dose. Dosage should be adjusted gradually with 3 days between dosing increments to achieve steady-state concentrations, and to allow time to monitor QT intervals. Monitor and adjust dose to prevent QTc prolongation.

Disease-related concerns:

• Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta-blockers; if used at all, should be used cautiously with close monitoring. Sotalol is contraindicated in patients with bronchial asthma or related bronchospastic conditions.

• Conduction abnormality: Consider preexisting conditions such as sick sinus syndrome before initiating.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

• Electrolyte imbalances: Correct electrolyte imbalances before initiating (especially hypokalemia and hypomagnesemia) because these conditions increase the risk of torsades de pointes.

• Heart failure (HF): New onset or worsening heart failure may occur during initiation or titration. Use with caution in patients with compensated heart failure; monitor for a worsening of the condition and discontinue if symptoms of heart failure occur. Use is contraindicated in patients with uncontrolled (or decompensated) heart failure.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may worsen disease.

• Myocardial infarction: Use with caution within the first 2 weeks post-MI, especially in patients with markedly impaired ventricular function (experience limited).

• Peripheral vascular disease (PVD) and Raynaud disease: Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.

• Pheochromocytoma (untreated): Adequate alpha-blockade is required prior to use of any beta-blocker.

• Psychiatric disease: Use with caution in patients with a history of psychiatric illness; may cause or exacerbate CNS depression.

• Renal impairment: [US Boxed Warning]: Adjust dosing interval based on CrCl to decrease risk of proarrhythmia; QT interval prolongation is directly related to sotalol concentration. CrCl must be calculated with dose initiation and dose increases. The use of sotalol is contraindicated in patients with CrCl <40 mL/minute (sotalol injection, Sotylize, and Betapace/Betapace AF [when used for atrial fibrillation/atrial flutter]).

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If thyrotoxicosis is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Elderly: Bradycardia may be observed more frequently in elderly patients (>65 years of age); dosage reductions may be necessary.

Dosage form specific issues:

• Product interchange: Oral: [US Boxed Warning]: Sotalol is indicated for both the treatment of documented life-threatening ventricular arrhythmias (marketed as Betapace/Betapace AF, Sorine, and Sotylize) and for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation/flutter who are currently in sinus rhythm (marketed as Betapace/Betapace AF and Sotylize). Sorine should not be substituted for sotalol AF.

Other warnings/precautions:

• Abrupt withdrawal: Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency. When QTc prolongation occurs, consider weighing the risk of abrupt withdrawal of sotalol with the risk of QTc prolongation. Use of an alternative beta-blocker may be indicated if worsening angina or acute coronary insufficiency occurs when sotalol is withdrawn abruptly due to QTc prolongation.

• Major surgery: Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.

Monitoring Parameters

Serum creatinine (creatinine clearance), magnesium, potassium; heart rate, blood pressure; ECG (eg, QTc interval, PR interval). If baseline QTc >450 msec (or JT interval >330 msec if QRS over 100 msec [sotalol injection]), sotalol (Betapace/Betapace AF, Sotylize) is contraindicated.

Betapace/Betapace AF, Sotylize: During initiation and titration period, monitor QTc interval 2 to 4 hours after each dose. If QTc interval is ≥500 msec, reduce dose, prolong the dosing interval, or discontinue sotalol. If the QTc interval is <500 msec after 3 days (after fifth or sixth dose if patient receiving once-daily dosing), patient may be discharged on current regimen. Monitor QTc interval periodically thereafter.

For IV use, measure QTc interval after completion of each infusion.

Consult individual institutional policies and procedures.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in the initial animal reproduction studies. Sotalol crosses the placenta and is found in amniotic fluid. Adverse events, such as fetal/neonatal bradycardia, hypoglycemia, and reduced birth weight have been observed following in utero exposure to beta-blockers as a class. Adequate facilities for monitoring infants at birth are generally recommended.

Sotalol crosses the placenta in concentrations similar to the maternal serum and it is generally preferred for the treatment of fetal atrial flutter (Namouz-Haddad 2013).

The clearance of sotalol is increased during the third trimester of pregnancy, but other pharmacokinetic parameters do not significantly differ from nonpregnant values (O’Hare 1983). Use of sotalol may be considered for some cardiac arrhythmias when use of a beta-blocker is needed during pregnancy (ESC [Regitz-Zagrosek 2011]).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, diarrhea, vomiting, or nausea. Have patient report immediately to prescriber severe dizziness; passing out; angina; bradycardia; tachycardia; abnormal heartbeat; severe loss of strength and energy; vision changes; shortness of breath; excessive weight gain; swelling of arms or legs; injection site pain, irritation, or edema; or sweating a lot (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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