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Sotalol Hydrochloride

Class: beta-Adrenergic Blocking Agents
VA Class: CV100
Chemical Name: Methanesulfonamide,N-[4-[1-Hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]monohydrochloride
Molecular Formula: C12H20N2O3S•ClH
CAS Number: 959-24-0
Brands: Betapace, Betapace AF, Sorine, Sotylize

Medically reviewed on Oct 29, 2018

Warning

  • Risk of life-threatening ventricular tachycardia associated with QT interval prolongation.1 402 403 404

  • Initiate or reinitiate therapy (or perform conversion from IV to oral therapy) in a facility that can provide cardiac resuscitation, continuous ECG monitoring, and Clcr calculations.1 402 403 404 (See Proarrhythmic Effects under Cautions.)

  • Do not initiate sotalol if baseline QTc >450 msec.402 403 If prolongation of QT interval to ≥500 msec occurs during therapy, reduce dose, increase dosing interval, or discontinue therapy.1 402 403 404

  • Calculate Clcr and adjust dosing interval accordingly.1 402 403 404 (See General under Dosage and Administration.)

Introduction

Nonselective β-adrenergic blocking agent; exhibits antiarrhythmic activity characteristic of class II antiarrhythmic agents and electrophysiologic effects characteristic of class III antiarrhythmic agents.1 2 7 8 12 13 14 15 402 403 404

Uses for Sotalol Hydrochloride

Ventricular Arrhythmias

Used to suppress and prevent recurrence of documented life-threatening ventricular arrhythmias (e.g., sustained ventricular tachycardia);1 4 5 6 7 8 11 12 26 400 401 402 403 404 405 designated an orphan drug by FDA for such use.9

Shown to be effective in patients with life-threatening ventricular arrhythmias (e.g., sustained ventricular tachycardia or fibrillation) as well as those with less severe arrhythmias (e.g., premature ventricular complexes [PVCs], paired PVCs, nonsustained ventricular tachycardia)1 4 5 6 7 11 12 402 403 404

Although antiarrhythmic drugs, including sotalol, may suppress the recurrence of arrhythmias and improve symptoms, there is no evidence from randomized controlled studies indicating that these drugs have a beneficial effect on mortality or sudden death.1 405

Because of arrhythmogenic potential, lack of evidence for improved survival, and risk of serious adverse effects (see Proarrhythmic Effects under Cautions), use in patients with less severe arrhythmias, even if symptomatic, generally not recommended.1 402 403

Avoid treatment of asymptomatic PVCs.1 3 4 7 8 12 14 402 403 404

Not a first-line drug of choice during cardiac arrest, but may be used for treatment of hemodynamically stable sustained monomorphic ventricular tachycardia; included in current ACLS guidelines for adult tachycardia.400 401 405

Supraventricular Arrhythmias

Used to maintain normal sinus rhythm in patients with symptomatic atrial fibrillation or flutter who are currently in sinus rhythm.1 301 402 403 404

Because of potential for life-threatening ventricular arrhythmias, reserve use for highly symptomatic atrial fibrillation/flutter.1 42 51 56 57 402 403 404 (See Proarrhythmic Effects under Cautions.) Do not use in patients with easily reversible (e.g., with Valsalva maneuver) paroxysmal atrial fibrillation.1 402 403 404

Efficacy in preventing atrial fibrillation or flutter recurrences is comparable to that of quinidine or propafenone and less than that of amiodarone.43 44 45 47 301

Also has been used for treatment of other supraventricular tachycardias (SVTs), including paroxysmal supraventricular tachycardia (PSVT) due to AV nodal reentry tachycardia (AVNRT) or AV reentry tachycardia (AVRT).64 300

Sotalol Hydrochloride Dosage and Administration

General

  • Initiate or reinitiate therapy and adjust dosage (or perform conversion from IV to oral therapy) in an institutional setting where patient can be monitored by personnel trained in the management of serious arrhythmias.1 7 8 42 48 402 403 404 (See Boxed Warning.)

  • Closely monitor patient for ≥3 days (or until steady-state plasma concentrations are achieved) whenever treatment is initiated, reinitiated, or dosage is increased.1 402 403 404

  • Prior to treatment, calculate Clcr and determine QTc interval.1 402 403 404 (See Contraindications under Cautions.) When titrating dosage, monitor QT interval 2–4 hours after each dose increase (if given orally) or after completion of each IV infusion.1 402 403 404

  • Individualize dosage according to Clcr and QTc.1 403 404 Discontinue therapy, reduce dose, or increase dosing interval if QTc ≥500 msec.1 403 404

  • Measure serum potassium and magnesium concentrations prior to initiating therapy and correct any imbalances.1 404

  • Ensure adequate anticoagulation in patients with atrial fibrillation/flutter.402

Conversion from Other Antiarrhythmic Agents

  • A transition period is recommended for patients converting from another antiarrhythmic agent to sotalol.1 404

  • In general, delay initiation of sotalol for a period of at least 2–3 elimination half-lives of the previously administered antiarrhythmic drug; monitor patients carefully during transition.1 404 (See Specific Drugs under Interactions.)

Administration

Administer orally or by IV infusion (when oral administration not feasible).1 402 403 404

Oral Administration

Administer orally as a tablet or oral solution (using the commercially available oral solution or an extemporaneously prepared solution).1 403 404

Administer oral solution using appropriate measuring device (e.g., oral dosing syringe); use of a teaspoon or tablespoon may result in dosing errors and is not recommended.403

Do not administer aluminum oxide and magnesium hydroxide-containing antacids within 2 hours of administration of sotalol.1 (See Specific Drugs under Interactions.)

Extemporaneous Oral Solution

To prepare extemporaneous oral solution, add 5 tablets (120 mg each) to a 180-mL polyethylene terephthalate (PET) prescription bottle containing 120 mL of simple syrup with 0.1% sodium benzoate (syrup NF); an oversized bottle is used to allow more effective shaking of the mixture.1 404

May add tablets intact to syrup, add syrup to tablets, or crush tablets (making sure to add entire quantity of tablet powder to syrup).1 404

Shake mixture to wet tablets, allow to hydrate for ≥2 hours, then shake intermittently over another 2 hours until dispersion of fine particles is obtained; may hydrate overnight to simplify disintegration process.1 404

If tablets are crushed, shake until a dispersion of fine particles is obtained.1 404

Resulting preparation contains 5 mg/mL of sotalol hydrochloride in solution with suspended inactive solid particles (water-insoluble tablet ingredients).1 (See Storage under Stability.)

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion over 5 hours.402 Use a volumetric pump to ensure that drug is delivered at a constant rate.402

Must dilute commercially available injection concentrate with a suitable diluent (i.e., 0.9% sodium chloride injection, 5% dextrose injection, lactated Ringer’s injection) prior to administration.402 Manufacturer recommends that the volume of injection concentrate used to prepare the infusion solution and the final infusion solution volume exceed those required for the intended dose to account for dead space in infusion set.402 Preparation of a final volume of 120 or 300 mL is recommended; however, actual volume that should be infused is 100 or 250 mL, respectively.402 (See Table 1.)

Table 1. Sotalol Infusion Preparation Guidelines to Compensate for Dead Space in Infusion Set

Target IV Dose

Amount of Injection Concentrate (mL)

Amount of Diluent (mL)

Total Volume Prepared (mL)

Volume to Infuse (mL)

75 mg

6

114

120

100

6

294

300

250

112.5 mg

9

111

120

100

9

291

300

250

150 mg

12

108

120

100

12

288

300

250

Dosage

Available as sotalol hydrochloride; dosage expressed in terms of the salt.1 402 403 404 Adjust dosage carefully according to individual requirements and response, patient tolerance, renal function, and QT interval.1 4 8 402 403 404

If a dose is missed, skip dose and take next dose at regularly scheduled time.1 403 404 Do not take a double dose or increase dosing frequency to compensate for missed dose.1 403 404

Pediatric Patients

Life-threatening Ventricular Arrhythmias or Atrial Fibrillation/Flutter

Dosage in pediatric patients is based on pharmacokinetic data; safety and efficacy not evaluated in this population.1 402 403 404 Take the same precautions as in adults.1 402 403 404 Individualize dosage based on clinical response, heart rate, and QTc.1 402 404

There are no studies of IV sotalol in pediatric patients.402

Oral

Children ≥2 years of age with normal renal function: Initially, 30 mg/m2 3 times daily (total daily dose of 90 mg/m2).1 402 403 404 May titrate dosage to maximum of 60 mg/m2 3 times daily (equivalent to total daily dose of 360 mg in adults).1 402 403 404 Allow ≥36 hours to elapse between dosage escalations to achieve steady-state concentrations.1 402 403 404

Children ≤2 years of age: Calculate dosage by multiplying the recommended initial dosage for children ≥2 years of age (i.e., 30 mg/m2 3 times daily) by an age-dependent factor obtained from manufacturer’s prescribing information.1 402 403 404 The age-dependent factor is approximately 0.3 in neonates 1 week old, 0.68 in infants 1 month of age, and 0.97 in infants 20 months of age.1 402 403 404 (See Table 2.) Use similar calculations for dosage increases.402 403 404

To obtain dosages for ages not mentioned in this table, see age/factor graph in manufacturer’s prescribing information

See age/factor graph in manufacturer’s prescribing information for age-dependent factor

Table 2. Initial Pediatric Dosages (age-adjusted) for Children ≤2 Years of Age 1402403404

Age

Initial Dosage Calculation (dosage for children ≥2 years of age [30 mg/m2 3 times daily] multiplied by an age-dependent factor)1 402 403 404

Neonates about 1 week of age

30 mg/m2 × 0.3 = 9 mg/m2 administered 3 times daily

Infants 1 month of age

30 mg/m2 × 0.68 = 20 mg/m2 administered 3 times daily

Infants 20 months of age

30 mg/m2 × 0.97 = 29.1 mg/m2 administered 3 times daily

Adults

Life-threatening Ventricular Arrhythmias
Oral

Initially, 80 mg twice daily in adults with normal renal function (Clcr >60 mL/minute).1 403 404 405 May increase dosage in increments of 80 mg per day every 3 days if QTc <500 msec.1 403 404

Usual maintenance dosage: 160–320 mg daily in 2 or 3 divided doses;1 404 dosing >2 times a day usually not necessary.1 404

Dosages as high as 480–640 mg daily have been used in patients with refractory life-threatening arrhythmias; however, risk of arrhythmic events increases with increasing dosage.1 8 403 404 (See Proarrhythmic Effects under Cautions.)

IV

Equivalent IV doses of sotalol hydrochloride are lower than oral doses; corresponding IV doses are as follows: 75 mg for an oral dose of 80 mg, 112.5 mg for an oral dose of 120 mg, and 150 mg for an oral dose of 160 mg.402

Initially, 75 mg once or twice daily (depending on Clcr) by IV infusion over 5 hours.402 405 (See Renal Impairment under Dosage and Administration.) If desired response not achieved and drug is well tolerated without excessive QT interval prolongation, may increase dosage to 112.5 mg once or twice daily (depending on Clcr); manufacturer recommends that dosage be increased in increments of 75 mg daily every 3 days.402 Closely monitor ECG and QT interval during dose increases.402

Based on experience with oral sotalol hydrochloride, the usual therapeutic effect should be observed with IV dosages of 75–150 mg once or twice daily; however, patients with life-threatening refractory ventricular arrhythmias have received higher dosages (e.g., oral dosages of 240–320 mg once or twice daily corresponding to IV dosages of 225–300 mg once or twice daily).402

Atrial Fibrillation or Flutter
Oral

For maintenance of normal sinus rhythm in adults with atrial fibrillation or flutter who have normal renal function (Clcr >60 mL/minute): Initially, 80 mg twice daily.1 42 61 403 404 May increase dosage in increments of 80 mg per day every 3 days if QTc <500 msec.1 403 404

In a dose-response study, the most effective dosage was 120 mg once or twice daily.1 42 45 403 404 Some clinicians state that dosage may be increased up to a maximum of 160 mg twice daily (provided drug is well tolerated and QTc <500 msec).26 47 50 403

IV

Equivalent IV doses of sotalol hydrochloride are lower than oral doses; corresponding IV doses are as follows: 75 mg for an oral dose of 80 mg, 112.5 mg for an oral dose of 120 mg, and 150 mg for an oral dose of 160 mg.402

For maintenance of normal sinus rhythm in adults with atrial fibrillation or flutter: Initially, 75 mg once or twice daily (depending on Clcr) by IV infusion over 5 hours.402 (See Renal Impairment under Dosage and Administration.)

If desired response not achieved and drug is well tolerated without excessive QT interval prolongation, may increase dosage after at least 3 days to 112.5 mg once or twice daily (depending on Clcr).402 Closely monitor ECG and QT interval during dose increases.402

Based on experience with oral sotalol hydrochloride, the usual therapeutic effect should be observed with an IV dosage of 112.5 mg once or twice daily; however, manufacturer states that dosage may be increased up to 150 mg once or twice daily if necessary provided drug is well tolerated.402

Prescribing Limits

Pediatric Patients

Life-threatening Ventricular Arrhythmias or Atrial Fibrillation/Flutter
Oral

Children ≥2 years of age: Maximum of 60 mg/m2 3 times daily.1

Children ≤2 years of age: Reduce maximum dosage in children ≥2 years of age (i.e., 60 mg/m2 3 times daily) by an age-dependent factor obtained from manufacturer’s prescribing information.1 (See Dosage: Pediatric Patients, under Dosage and Administration.)

Adults

Atrial Fibrillation or Flutter
Oral

Some clinicians recommend maximum of 320 mg daily (160 mg twice daily);26 47 50 404 increased incidence of torsades de pointes with higher dosages.1 47 403 (See Proarrhythmic Effects under Cautions.)

Special Populations

Hepatic Impairment

Manufacturers make no specific dosage recommendations.1 402 403 404

Renal Impairment

Reduce dose or dosing frequency to minimize risk of proarrhythmia; as in patients with normal renal function, closely monitor QT interval and heart rate.1 26 402 403 404 (See Proarrhythmic Effects under Cautions.)

Modify dosing interval according to Clcr.1 402 403 404 In general, administer the initial oral adult dose of 80 mg and subsequent doses twice daily in adults with Clcr>60 mL/minute and once daily in adults with Clcr 40–60 mL/minute.402 403 Generally contraindicated in patients with Clcr<40 mL/minute.1 402 403 404 In patients with ventricular arrhythmias, some manufacturers recommend a dosing interval of 36–48 hours in adults with Clcr 10–29 mL/minute and individualized dosing in those with Clcr<10 mL/minute.1 404

Since elimination half-life is prolonged in patients with renal impairment, dosage increases generally should be made after administration of at least 5 doses at appropriate intervals.1 8 404

Dosage in children with renal impairment not established.1 404 However, reduced doses and increased dosing intervals recommended for all age groups with renal impairment.1 404

Sotalol is partially removed by dialysis; however, manufacturers make no dosing recommendations for patients undergoing dialysis.1 404

Geriatric Patients

Modification of dosage based on age alone is not necessary.1

Because geriatric patients may have decreased renal function and because patients with renal impairment may be at increased risk of sotalol-induced toxicity, monitor closely and adjust dosage accordingly.1 (See Renal Impairment under Dosage and Administration.)

Cautions for Sotalol Hydrochloride

Contraindications

  • Bronchial asthma or related bronchospastic conditions.1 42 43 44 47 48 49 402 403 404

  • Sinus bradycardia (<50 bpm while awake).1 42 43 44 47 48 49 402 403 404

  • Sick sinus syndrome or second or third degree AV block unless a functioning pacemaker is present.1 42 43 44 45 47 48 49 402 403 404

  • Congenital or acquired long QT interval syndromes.1 42 43 44 47 48 49 402 403 404

  • Baseline QT interval >450 msec (some manufacturers state this is a contraindication only in patients being treated for atrial fibrillation or flutter).1 42 402 403 404

  • Cardiogenic shock.1 42 43 44 47 48 49 402 403 404

  • Decompensated heart failure.1 42 43 44 47 48 49 402 403 404

  • Hypokalemia (serum potassium <4 mEq/L).1 402 403 404

  • Clcr <40 mL/minute (some manufacturers state this is a contraindication only in patients being treated for atrial fibrillation or flutter).1 402 403 404

  • Known hypersensitivity to sotalol or any ingredient in the formulation.1 42 43 44 47 48 49 403 404

Warnings/Precautions

Warnings

Proarrhythmic Effects

Can cause serious ventricular arrhythmias, principally torsades de pointes, associated with prolonged QT interval; risk increases progressively with QT interval prolongation.1 6 8 28 402 403 404 (See Boxed Warning.)

Arrhythmogenic events occur not only when initiating therapy, but with every upward dosage adjustment.1 3 4 7 47 402 404

QT interval prolongation is dose related.1 402 403 404

Risk of torsades de pointes increases with decreased Clcr, female gender, larger doses, reduction of heart rate, hypokalemia,1 3 402 404 presence of sustained ventricular tachycardia, excessive QTc interval prolongation, history of cardiomegaly or heart failure.1 402 Decrease risk by adjusting dosage based on Clcr and monitoring ECG for excessive QT interval prolongation.1 402 404 Take appropriate precautions during administration.1 402 403 404 (See General under Dosage and Administration.)

Heart Failure

New onset or worsening heart failure may occur.1 403 404 Use contraindicated in patients with decompensated heart failure.1 403 404 (See Contraindications under Cautions.)

Monitor for signs and symptoms of heart failure and discontinue therapy if symptoms occur.1

Electrolyte Disturbances

Electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia) may exaggerate the degree of QT interval prolongation and increase the risk of torsades de pointes.1 3 403 404 Use not recommended until these imbalances are corrected.1 42 45 48 403 404

Carefully monitor electrolyte and acid-base balance in patients with severe or prolonged diarrhea and in patients receiving diuretics concomitantly.1 45 47 50 402 403 404

Bradycardia

Potential bradycardia in patients treated for supraventricular arrhythmias; associated with increased risk of torsades de pointes.1 403 404

Abrupt Withdrawal of Therapy

Abrupt withdrawal may exacerbate angina symptoms and/or precipitate MI, particularly in patients with ischemic heart disease, or may precipitate thyroid storm in patients with thyroid disease.1 402 403 404

Avoid abrupt discontinuance.1 402 403 404 If possible, gradually decrease dosage over a period of 1–2 weeks when discontinuing therapy, particularly in patients with ischemic heart disease; monitor patients.1 402 403 404

If exacerbation of angina occurs or acute coronary insufficiency develops, initiate appropriate treatment (e.g., temporary use of another β-blocker).1 403 404

Bronchospastic Disease

Use contraindicated in patients with bronchial asthma or related bronchospastic conditions.1 402 403 404 (See Contraindications under Cautions.)

Use not recommended in patients with nonallergic bronchospasm (e.g., chronic bronchitis, emphysema);1 402 404 use smallest effective dosage to minimize inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of β2-adrenergic receptors.1 402 403 404

History of Anaphylactic Reactions

Possible increased reactivity to a variety of allergens; patients may be unresponsive to usual doses of epinephrine used to treat anaphylactic reactions.1 402 403 404

Surgery

Some controversy exists regarding use of β-blockers during surgery.34 402 Hypotension, bradycardia, and stroke have occurred; in addition, it is unclear whether such use confers mortality benefits or risks.34 35 402

Generally continue β-blockers during surgery in patients who are already receiving these drugs for a chronic condition.1 34 404 Consider risks versus benefits in individual patients.1 34 404

Hypotension

Hypotension reported;1 402 403 404 monitor BP in patients with marginal cardiac compensation.1 402 403 404

Diabetes Mellitus

Possible decreased signs and symptoms of acute hypoglycemia (e.g., tachycardia).1 402 404 May increase blood glucose concentrations and insulin requirements in diabetic patients.1 402 404

Sick Sinus Syndrome

Possible increased risk of torsades de pointes in patients with atrial fibrillation and sinus node dysfunction, especially after cardioversion.49 50 402 403 Use contraindicated in patients with sick sinus syndrome unless a functioning pacemaker is present due to risk of sinus bradycardia, sinus pause, or sinus arrest.1 45 48 402 403 (See Contraindications under Cautions.)

Thyroid Abnormalities

Signs of hyperthyroidism (e.g., tachycardia) may be masked.1 402 403 404

Possible thyroid storm if therapy is abruptly withdrawn.1 402 403 404 (See Abrupt Withdrawal of Therapy under Cautions.)

General Precautions

Other Precautions

Shares the toxic potentials of other nonselective β-adrenergic blocking agents; observe usual precautions of these agents.1 3 4 5 6 7 8

Specific Populations

Pregnancy

Category B.1 402 403 404

Lactation

Distributed into milk.1 402 403 404 Discontinue nursing or the drug.1 403 404

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 26 402 403 404

Class III electrophysiologic and β-blocking effects, pharmacokinetics and the relationship between plasma concentrations and effects (e.g., QTc intervals, resting heart rate) have been evaluated in children 3 days to 12 years of age.1 402 403 404

Has been effective in a limited number of infants <3 months of age29 30 and children <18 years of age30 for supraventricular arrhythmias; 29 30 less effective for ventricular arrhythmias.30 Mild sinus bradycardia occurred in most infants;29 fatigue occurred in several children and required discontinuance in a few.30

Similar to adults, serious adverse events including death, torsades de pointes, other proarrhythmias, AV block, and bradycardia have been reported in infants and children; usual precautions in adults should also be observed in pediatric patients.1 402

Geriatric Use

Insufficient experience in geriatric patients to determine whether safety and efficacy in geriatric patients differ from safety and efficacy in younger adults; however clinical trials of sotalol included many patients >50 years of age.3 4 5 6 8

Overall risk of cardiac death was associated with increasing age in clinical trials.8

Monitor closely and adjust dosage accordingly due to greater frequency of decreased renal function and increased risk of toxicity observed in the elderly.1 403

Hepatic Impairment

Clearance of sotalol not altered by hepatic impairment.1 402 403 404

Renal Impairment

Clearance is decreased depending on degree of renal impairment.1 (See Special Populations under Pharmacokinetics.)

Dosage adjustments necessary based on degree of renal impairment.1 404 (See Renal Impairment under Dosage and Administration.)

Partially removed by dialysis;1 404 monitor closely for efficacy of arrhythmia control and adverse effects (changes in heart rate and/or QT interval).1

Common Adverse Effects

Common adverse effects based on use of oral sotalol: Sinus bradycardia (heart rate <50 bpm),1 3 4 5 28 402 arrhythmogenic effects,1 402 chest pain,1 3 28 402 palpitation,1 3 28 402 hypotension,1 402 fatigue,1 3 28 42 402 dizziness,1 3 28 42 asthenia,1 3 28 hyperhidrosis,1 402 lightheadedness,1 402 upper respiratory tract problems,1 visual problems,1 sleep problems,1 402 weakness,1 402 dyspnea,1 3 28 402 headache,1 402 cough,1 nausea,1 3 vomiting,1 3 402 diarrhea,1 402 abdominal pain,1 edema,402 extremity pain.402

Interactions for Sotalol Hydrochloride

Drugs metabolized by CYP isoenzymes do not alter the pharmacokinetics of sotalol; sotalol does not induce or inhibit any CYP isoenzymes.1 404

Specific Drugs

Drug or Test

Interaction

Comments

Antacids (aluminum- or magnesium-containing)

Decreased absorption of sotalol and reduced bradycardic effect1 403 404

Do not administer within 2 hours of sotalol;1 403 404 no effects on sotalol pharmacokinetics or pharmacodynamics observed when administered 2 hours after sotalol1 404

Antiarrhythmics, class Ia (e.g., disopyramide, quinidine, procainamide)

May prolong refractoriness and increase risk of QT interval prolongation1 402 403 404

Concomitant use not recommended; withhold for at least 3 half-lives before initiating sotalol1 1 402 403 404

Antiarrhythmics, class Ib or Ic

Limited experience with concomitant use1 403 404

Withhold for at least 3 half-lives before initiating sotalol1

Antiarrhythmics, class II (β-blockers)

Possible additive class II (β-adrenergic receptor blocking) effects1 404

Antiarrhythmics, class III (e.g., amiodarone)

May prolong refractoriness and increase risk of QT interval prolongation1 402 403 404

Concomitant use not recommended;1 42 402 404 withhold for at least 3 half-lives before initiating sotalol1 402 403 404

Antidepressants, tricyclics

Prolongs QT interval1 42 403 404

Concomitant use not recommended1 403 404

Antidiabetic agents (oral)

May cause hyperglycemia1 403 404

May require antidiabetic agent dosage adjustment 1 403 404

Calcium-channel blocking agents

Possible additive effects on AV conduction or ventricular function; also potential for additive bradycardia and hypotensive effects1 402 403 404

Use concomitantly with caution1 404

Clonidine

Increased risk of bradycardia; in addition, β-blockers may potentiate rebound hypertension that occasionally occurs after discontinuance of clonidine1 402 403 404

To reduce risk of rebound hypertension, withdraw sotalol several days before the gradual withdrawal of clonidine1 404

Digoxin

Possible increased proarrhythmic events1 402 403 404

Concomitant use increases risk of bradycardia1 404

Unclear if proarrhythmias are the result of interaction or presence of heart failure (known proarrhythmia risk factor)1

Hydrochlorothiazide

No pharmacokinetic interaction observed1

Insulin

May cause hyperglycemia;1 402 403 404 may mask hypoglycemic symptoms402

Adjust insulin dosage, if necessary 1 402 403 404

Macrolides (e.g., azithromycin, clarithromycin)

Possible prolonged QT interval1 403 404 405

Concomitant use not recommended1 403 404 405

Phenothiazines

May prolong QT interval1 403 404

Concomitant use not recommended1 42 404

Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin)

May prolong QT interval1 42 403 404 405

Concomitant use not recommended1 42 403 404 405

β2-Receptor agonists (e.g., albuterol, terbutaline, isoproterenol)

Increased dosages of β2-receptor agonists may be required403

Reserpine

Concomitant use may cause excessive decrease in resting sympathetic tone1 402 404

Monitor closely for evidence of hypotension or marked bradycardia that may produce syncope1 402 404

Warfarin

No pharmacokinetic interaction observed1 402

Sotalol Hydrochloride Pharmacokinetics

Absorption

Bioavailability

90–100%.1 403 404

Peak plasma concentrations are reached in 2.5–4 hours following oral administration.1 403 404

Steady-state plasma concentrations are reached in 2–3 days following twice-daily oral administration.1 403 404

Food

Food reduces oral bioavailability by about 20%.1 403 404

Distribution

Extent

Crosses the placenta; found in amniotic fluid.402 404

Does not readily cross blood-brain barrier.1 403 404

Plasma Protein Binding

Does not bind to plasma proteins.1 403 404

Elimination

Metabolism

Not metabolized.1 404

Elimination Route

Eliminated principally by glomerular filtration and tubular secretion; excreted principally unchanged in urine.1 403 404

Half-life

12 hours.1 403 404

Special Populations

Renal impairment may reduce clearance.1 404 Elimination half-life in anuric patients may be prolonged (up to 69 hours).1 404 (See Renal Impairment under Dosage and Administration.)

In pediatric patients, half-life decreases with decreasing age <2 years of age.402

Stability

Storage

Oral

Solution

Commercially available oral solution: 20–25°C (may be exposed to 15–30°C).403

Extemporaneous oral solution: 15–30°C at ambient humidity; stable for ≤3 months after preparation.1

Tablets

Tight, light-resistant container at 20–25°C (may be exposed to 15–30°C).1 404

Parenteral

Injection

20–25°C.402 Protect from freezing and light.402

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility402

Compatible

Dextrose 5%

Ringer’s injection, lactated

Sodium chloride 0.9%

Actions

  • Inhibits response to adrenergic stimuli by competitively blocking β1-adrenergic receptors within the myocardium and β2-adrenergic receptors within bronchial and vascular smooth muscle.2 7 8

  • Exhibits antiarrhythmic activity characteristic of class II antiarrhythmic agents.1 2 7 8 404

  • Does not exhibit membrane-stabilizing activity,1 8 but exhibits electrophysiologic effects characteristic of class III antiarrhythmic agents (e.g., prolongs repolarization and refractoriness without affecting conduction).1 2 7 8 12 13 14 15

  • Does not exhibit intrinsic sympathomimetic activity.8

  • Selectively inhibits the rapidly activating component of the potassium channel involved in repolarization of cardiac cells (i.e., the rapidly activated inward component of the delayed rectifier potassium current IKr) in vitro.12 13 14 15

  • Does not appear to block sodium channels at usual doses (although it may at relatively high doses).12 16 26 27

  • Racemic mixture of 2 optical isomers that both exhibit class III antiarrhythmic activity,1 7 11 14 15 but only the l-isomer exhibits β-blocking activity.1 7 11 14 404

Advice to Patients

  • If a dose is missed, importance of taking next scheduled dose at the usual time and not doubling the dose to make up for missed dose.1 403

  • Importance of patients immediately contacting their clinician if syncope, pre-syncopal symptoms, or cardiac palpitations occur.1 402 403 404

  • Importance of advising patients that their electrolytes and ECG will be monitored during treatment.1 404

  • Importance of informing patients (especially those with ischemic heart disease) not to interrupt or discontinue therapy without consulting clinician and to fill their prescriptions on time to avoid treatment interruption.1 404

  • Importance of informing patients not to take sotalol tablets or oral solution 2 hours before or after administration of an antacid containing aluminum oxide or magnesium hydroxide (e.g., Maalox, Mylanta).1 403 404

  • Importance of immediately reporting to their clinician any conditions, concomitant therapy (e.g., diuretics), and/or manifestations associated with altered electrolyte balance (e.g., severe or prolonged diarrhea, unusual sweating, vomiting, loss of appetite, excessive thirst).1 403 404

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sotalol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

25 mg/5 mL

Sotylize

Arbor

Tablets

80 mg*

Betapace (scored)

Covis

Betapace AF (scored)

Covis

Sorine (scored)

Upsher-Smith

Sotalol Hydrochloride Tablets (scored)

120 mg*

Betapace (scored)

Covis

Betapace AF (scored)

Covis

Sorine (scored)

Upsher-Smith

Sotalol Hydrochloride Tablets (scored)

160 mg*

Betapace (scored)

Covis

Betapace AF (scored)

Covis

Sorine (scored)

Upsher-Smith

Sotalol Hydrochloride Tablets (scored)

240 mg*

Sorine (scored)

Upsher-Smith

Sotalol Hydrochloride Tablets (scored)

Parenteral

Injection concentrate, for IV infusion

15 mg/mL*

Sotalol Hydrochloride Injection

AHFS DI Essentials™. © Copyright 2018, Selected Revisions October 29, 2018. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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