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Sotalol


Pronunciation

 (SOE ta lole)


U.S. Brand Names

 Betapace®; Betapace AF®; Sorine®


Synonyms

 Sotalol Hydrochloride


Generic Available

 Yes


Canadian Brand Names

 Alti-Sotalol; Apo-Sotalol®; Betapace AF™; Gen-Sotalol; Lin-Sotalol; Novo-Sotalol; Nu-Sotalol; PMS-Sotalol; Rho®-Sotalol; Sotacor®


Use

 Treatment of documented ventricular arrhythmias (ie, sustained ventricular tachycardia), that in the judgment of the physician are life-threatening; maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation and atrial flutter who are currently in sinus rhythm. Manufacturer states substitutions should not be made for Betapace AF® since Betapace AF® is distributed with a patient package insert specific for atrial fibrillation/flutter.


Pregnancy Risk Factor

 B


Pregnancy Implications

 There are no adequate and well-controlled studies in pregnant women. Beta-blockers have been associated with bradycardia, hypotension, and IUGR; IUGR is probably related to maternal hypertension. Sotalol has been shown to cross the placenta, and is found in amniotic fluid; therefore, sotalol should be used during pregnancy only if the potential benefit outweighs the potential risk. Cases of neonatal hypoglycemia have been reported following maternal use of beta-blockers at parturition or during breast-feeding. Monitor breast-fed infant for symptoms of beta-blockade.


Lactation

 Enters breast milk/use caution (AAP rates "compatible")


Contraindications

 Hypersensitivity to sotalol or any component of the formulation; bronchial asthma; sinus bradycardia; second- and third-degree AV block (unless a functioning pacemaker is present); congenital or acquired long QT syndromes; cardiogenic shock; uncontrolled congestive heart failure. Betapace AF® is contraindicated in patients with significantly reduced renal filtration (Clcr<40 mL/minute).


Warnings/Precautions

 Must be initiated (or reinitiated) in a setting with continuous monitoring and staff familiar with the recognition and treatment of life-threatening arrhythmias. Patients must be monitored with continuous ECG for a minimum of 3 days (on their maintenance dose). Use cautiously in the renally-impaired (dosage adjustment required). Creatinine clearance must be calculated prior to dosing.

Monitor and adjust dose to prevent QTc prolongation. Concurrent use with other QTc-prolonging drugs (including Class I and Class III antiarrhythmics) is generally not recommended; withhold for 3 half-lives. Watch for proarrhythmic effects. Correct electrolyte imbalances before initiating (especially hypokalemia and hyperkalemia). Consider pre-existing conditions such as sick sinus syndrome before initiating. Conduction abnormalities can occur particularly sinus bradycardia. Use cautiously within the first 2 weeks post-MI (experience limited). Administer cautiously in compensated heart failure and monitor for a worsening of the condition. Use caution in patients with PVD (can aggravate arterial insufficiency). Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Use caution with concurrent use of beta-blockers and either verapamil or diltiazem; bradycardia or heart block can occur. Use cautiously in diabetics because it can mask prominent hypoglycemic symptoms. Can mask signs of thyrotoxicosis. Use care with anesthetic agents which decrease myocardial function.


Adverse Reactions

>10%:

Cardiovascular: Bradycardia (16%), chest pain (16%), palpitation (14%)

Central nervous system: Fatigue (20%), dizziness (20%), lightheadedness (12%)

Neuromuscular & skeletal: Weakness (13%)

Respiratory: Dyspnea (21%)

1% to 10%:

Cardiovascular: CHF (5%), peripheral vascular disorders (3%), edema (8%), abnormal ECG (7%), hypotension (6%), proarrhythmia (5%), syncope (5%)

Central nervous system: Mental confusion (6%), anxiety (4%), headache (8%), sleep problems (8%), depression (4%)

Dermatologic: Itching/rash (5%)

Endocrine & metabolic: Sexual ability decreased (3%)

Gastrointestinal: Diarrhea (7%), nausea/vomiting (10%), stomach discomfort (3% to 6%), flatulence (2%)

Genitourinary: Impotence (2%)

Hematologic: Bleeding (2%)

Neuromuscular & skeletal: Paresthesia (4%), extremity pain (7%), back pain (3%)

Ocular: Visual problems (5%)

Respiratory: Upper respiratory problems (5% to 8%), asthma (2%)

<1% (Limited to important or life-threatening): Alopecia, clouded sensorium, cold extremities, diaphoresis, emotional lability, eosinophilia, fever, hyperlipidemia, incoordination, leukopenia, myalgia, paralysis, phlebitis, photosensitivity reaction, pruritus, pulmonary edema, Raynaud's phenomenon, red crusted skin, serum transaminases increased, skin necrosis after extravasation, thrombocytopenia, vertigo, xerostomia

Postmarketing and/or case reports: Bronchiolitis obliterans with organized pneumonia, leukocytoclastic vasculitis, retroperitoneal fibrosis


Overdosage/Toxicology

 Symptoms of intoxication include cardiac disturbances, CNS toxicity, bronchospasm, hypoglycemia and hyperkalemia. The most common cardiac symptoms include hypotension and bradycardia; atrioventricular block, intraventricular conduction disturbances, cardiogenic shock, and asystole may occur with severe overdose, especially with membrane-depressant drugs (eg, propranolol); CNS effects include convulsions, coma, and respiratory arrest is commonly seen with propranolol and other membrane-depressant and lipid-soluble drugs.

Treatment includes symptomatic treatment of seizures, hypotension, hyperkalemia and hypoglycemia. Bradycardia and hypotension resistant to atropine, isoproterenol or pacing may respond to glucagon. Wide QRS defects caused by the membrane-depressant poisoning may respond to hypertonic sodium bicarbonate. Repeat-dose charcoal, hemoperfusion, or hemodialysis may be helpful in removal of only those beta-blockers with a small Vd, long half-life, or low intrinsic clearance (acebutolol, atenolol, nadolol, sotalol).


Drug Interactions

Amiodarone: May cause additive effects on QTc prolongation as well as decreased heart rate, and has been associated with cardiac arrest in patients receiving beta-blockers.

Antacids (aluminum/magnesium) decrease sotalol blood levels; separate administration by 2 hours.

Antiarrhythmics: Concurrent use of Class Ia or Class III antiarrhythmics may result in additive QTc prolongation; concurrent use is not recommended.

Beta2 agonists: Effects may be diminished by concurrent sotalol; use caution.

Beta-blockers: Due to shared pharmacological effects, heart rate reductions may be additive; concurrent use is not recommended.

Calcium channel blockers: Concurrent use may lead to additive effects on AV conduction, ventricular contractility, and/or hypotension; use caution.

Cisapride: Concurrent use with sotalol increases malignant arrhythmias; contraindicated.

Clonidine: Sotalol may cause rebound hypertension after discontinuation of clonidine.

QTc-prolonging drugs: Concurrent use may result in additive QTc prolongation, potentially increasing the risk of malignant arrhythmias. Use of cisapride, mesoridazine, thioridazine, and pimozide with other QTc-prolonging agents is contraindicated. Concurrent use of sotalol with Class I and Class III antiarrhythmics is not recommended; withhold for 3 half-lives. Use caution with other QTc-prolonging agents (including bepridil, erythromycin, clarithromycin), fluoroquinolones (including sparfloxacin, gatifloxacin, and moxifloxacin), haloperidol, and TCAs.

Phenothiazines (mesoridazine and thioridazine): Concurrent use may result in additive QTc prolongation, potentially increasing the risk of malignant arrhythmias; contraindicated.

Pimozide: Concurrent use may result in additive QTc prolongation, potentially increasing the risk of malignant arrhythmias; contraindicated.


Ethanol/Nutrition/Herb Interactions

Food: Sotalol peak serum concentrations may be decreased if taken with food.

Herb/Nutraceutical: Avoid ephedra (may worsen arrhythmia).


Stability

 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)


Mechanism of Action

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

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

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 320-640 mg/day]. Significant beta-blockade occurs at oral doses as low as 25 mg/day.

The Class III effects are seen only at oral doses 160 mg/day


Pharmacodynamics/Kinetics

Onset of action: Rapid, 1-2 hours

Peak effect: 2.5-4 hours

Duration: 8-16 hours

Absorption: Decreased 20% to 30% by meals compared to fasting

Distribution: Low lipid solubility; enters milk of laboratory animals and is reported to be present in human milk

Protein binding: None

Metabolism: None

Bioavailability: 90% to 100%

Half-life elimination: 12 hours; Children: 9.5 hours; terminal half-life decreases with age <2 years (may by 1 week in neonates)

Excretion: Urine (as unchanged drug)


Dosage

 Sotalol should be initiated and doses increased in a hospital with facilities for cardiac rhythm monitoring and assessment. Proarrhythmic events can occur after initiation of therapy and with each upward dosage adjustment.

Children: Oral: The safety and efficacy of sotalol in children have not been established

Note: Dosing per manufacturer, based on pediatric pharmacokinetic data; wait at least 36 hours between dosage adjustments to allow monitoring of QT intervals

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.

>2 years: Initial: 90 mg/m 2 /day in 3 divided doses; may be incrementally increased to a maximum of 180 mg/m 2 /day

Adults: Oral:

Ventricular arrhythmias (Betapace®, Sorine®):

Initial: 80 mg twice daily

Dose may be increased gradually to 240-320 mg/day; allow 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals

Most patients respond to a total daily dose of 160-320 mg/day in 2-3 divided doses.

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

Atrial fibrillation or atrial flutter (Betapace AF®): Initial: 80 mg twice daily

If the initial dose does not reduce the frequency of relapses of atrial fibrillation/flutter and is tolerated without excessive QT prolongation (not >520 msec) after 3 days, the dose may be increased to 120 mg twice daily. This may be further increased to 160 mg twice daily if response is inadequate and QT prolongation is not excessive.

Elderly: Age does not significantly alter the pharmacokinetics of sotalol, but impaired renal function in elderly patients can increase the terminal half-life, resulting in increased drug accumulation

Dosage adjustment in renal impairment: Adults: Impaired renal function can increase the terminal half-life, resulting in increased drug accumulation. Sotalol (Betapace AF®) is contraindicated per the manufacturer for treatment of atrial fibrillation/flutter in patients with a Clcr<40 mL/minute.

Ventricular arrhythmias (Betapace®, Sorine®):

Clcr >60 mL/minute: Administer every 12 hours

Clcr 30-60 mL/minute: Administer every 24 hours

Clcr 10-30 mL/minute: Administer every 36-48 hours

Clcr<10 mL/minute: Individualize dose

Atrial fibrillation/flutter (Betapace AF®):

Clcr >60 mL/minute: Administer every 12 hours

Clcr 40-60 mL/minute: Administer every 24 hours

Clcr<40 mL/minute: Use is contraindicated

Dialysis: Hemodialysis would be expected to reduce sotalol plasma concentrations because sotalol is not bound to plasma proteins and does not undergo extensive metabolism; administer dose postdialysis or administer supplemental 80 mg dose; peritoneal dialysis does not remove sotalol; supplemental dose is not necessary


Administration

 Food may decrease adsorption


Monitoring Parameters

 Serum magnesium, potassium, ECG


Dietary Considerations

 Administer on an empty stomach.


Patient Education

 Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medications without consulting prescriber. Take exactly as directed; do not adjust dosage or discontinue without consulting prescriber. Take pulse daily (prior to medication) and follow prescriber's instruction about holding of medication. If you have diabetes, monitor serum sugar closely (drug may alter glucose tolerance or mask signs of hypoglycemia). May cause fatigue, dizziness, lightheadedness, or postural hypotension (use caution when changing position from lying or sitting to standing, when driving, or climbing stairs until response to medication is known); alteration in sexual performance (reversible); nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (boiled milk, buttermilk, or yogurt may help). Report immediately any chest pain, palpitations, irregular heartbeat; swelling of extremities, respiratory difficulty, new cough, or unusual fatigue; persistent nausea, vomiting, or diarrhea; or unusual muscle weakness. Breast-feeding precaution: Consult prescriber if breast-feeding.


Nursing Implications

 Initiation of therapy and dose escalation should be done in a hospital with cardiac monitoring; lidocaine and other resuscitative measures should be available


Additional Information

 Pharmacokinetics in children are more relevant for BSA than age.


Anesthesia and Critical Care Concerns/Other Considerations

 Withdrawal: Beta-blocker therapy should not be withdrawn abruptly, but gradually tapered to avoid acute tachycardia and hypertension.


Cardiovascular Considerations

 As with other antiarrhythmics, sotalol is proarrhythmic (eg, torsade de pointes) and therapy with the d-isomer (d-sotalol) increased mortality, presumably due to arrhythmias, in patients with heart failure and myocardial infarction. It is therefore prudent to carefully select and monitor patients on sotalol and avoid its use in patients with a history of heart failure or myocardial infarction. Therapy should be initiated in a monitored setting with close attention to heart rate, QT interval, serum potassium and magnesium, and renal failure.


Dental Health: Effects on Dental Treatment

 Sotalol is a nonselective beta-blocker and may enhance the pressor response to epinephrine, resulting in hypertension and bradycardia. Many nonsteroidal anti-inflammatory drugs, such as ibuprofen and indomethacin, can reduce the hypotensive effect of beta-blockers after 3 or more weeks of therapy with the NSAID. Short-term NSAID use (ie, 3 days) requires no special precautions in patients taking beta-blockers.


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 Use with caution; epinephrine has interacted with nonselective beta-blockers to result in initial hypertensive episode followed by bradycardia


Mental Health: Effects on Mental Status

 Dizziness and drowsiness are common; may cause confusion, anxiety, or depression


Mental Health: Effects on Psychiatric Treatment

 Contraindicated with ziprasidone. May rarely cause leukopenia; use caution with clozapine and carbamazepine. Barbiturates may decrease the effects of beta-blockers; beta-blockers may alter the effects antipsychotics; monitor for altered response.


Dosage Forms

 Tablet, as hydrochloride: 80 mg, 80 mg [AF], 120 mg, 120 mg [AF], 160 mg, 160 mg [AF], 240 mg

Betapace® [light blue]: 80 mg, 120 mg, 160 mg, 240 mg

Betapace AF® [white]: 80 mg, 120 mg, 160 mg

Sorine® [white]: 80 mg, 120 mg, 160 mg, 240 mg


Extemporaneously Prepared

 To make a 5 mg/mL oral solution, using a 6-ounce amber plastic prescription bottle, add five sotalol 120 mg tablets to 120 mL of simple syrup containing 0.1% sodium benzoate (tablets do not need to be crushed). Shake well. Allow tablets to hydrate for ~2 hours; shake intermittently until tablets completely disintegrate. Store at room temperature; shake well before use. Stable for 3 months. (Refer to manufacturer's current labeling.)


References

"A Comparison of Antiarrhythmic-Drug Therapy With Implantable Defibrillators in Patients Resuscitated From Near-Fatal Ventricular Arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators," N Engl J Med , 1997, 337(22):1576-83.

"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics , 2001, 108(3):776-89.

Kuhlkamp V, Mewis C, Mermi J, et al, "Suppression of Sustained Ventricular Tachyarrhythmias: A Comparison of d,1-Sotalol With No Antiarrhythmic Drug Treatment," J Am Coll Cardiol , 1999, 33(1):46-52.

Mason JW, "A Comparison of Seven Antiarrhythmic Drugs in Patients With Ventricular Tachyarrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring Investigators," N Engl J Med , 1993, 329(7):452-8.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

Pacifico A, Hohnloser SH, Williams JH, et al, "Prevention of Implantable-Defibrillator Shocks by Treatment With Sotalol. d,1-Sotalol Implantable Cardioverter-Defibrillator Study Group," N Engl J Med , 1999, 340(24):1855-62.

Waldo AL, Camm AJ, deRuyter H, et al, "Effect of d-sotalol on Mortality in Patients With Left Ventricular Dysfunction After Recent and Remote Myocardial Infarction. The SWORD Investigators. Survival With Oral d-Sotalol," Lancet , 1996, 348(9019):7-12.


International Brand Names

 Alti-Sotalol (CA); Apo-Sotalol® (CA, NZ, SG); Beta Cardone® (GB); Betapace AF™ (CA); Biosotal® (PL); Cardol® (AU); Chem mart Sotalol® (AU); Cloridrato de Sotalol® (BR); CorSotalol® (DE); Darob® (AR, AT, DE, HR, PL, PT, RO, RU, SI, TR); Darob mite® (HR); DBL Sotalol (AU); Dutacor® (DK); Favorex® (DE); GenRX Sotalol® (AU); Gen-Sotalol (CA); Gilucor® (BG, DE, HR, PL, RO, YU); Healthsense Sotalol® (AU); Hipecor® (CL); Jutalex® (DE); Lin-Sotalol (CA); Merck-Sotalol® (BE); MTW-Sotalol® (DE); Novo-Sotalol (CA); Nu-Sotalol (CA); PMS-Sotalol (CA); Rentibloc® (DE); Rho®-Sotalol (CA); Rytmobeta® (IT); Sota AbZ® (DE); Sotab® (AU); Sotabeta® (DE); Sotacor® (AR, AT, AU, BR, CA, CO, DK, FI, GB, ID, IE, IL, NL, NO, NZ, SE, SG, ZA); Sotagamma® (DE); Sotahexal® (AT, AU, CZ, DE, HU, PL, RU, ZA); Sota Knoll® (DE); Sotalex® (BE, BG, CH, CZ, DE, FR, HU, IT, LU, PL, RO); Sota Lich® (DE); Sotalin® (FI); Sotalodoc® (DE); Sotalol 1A-Pharma® (DE); Sotalol acis® (DE); Sotalol AL® (CZ, DE, RO); Sotalol Arcana® (AT); Sotalol Basics® (DE); Sotalol-BC® (AU); Sotalol BC® (BE); Sotalol Biochemie® (FI); Sotalol Carinopharm® (DE); sotalol corax® (DE); Sotalol® (CZ, GB, NO, NZ, RO); Sotalol Dumex-Alpharma® (DK); Sotalol Ebewe® (AT); Sotalol Generics® (FI); Sotalol GM® (IL); Sotalol Heumann® (DE); Sotalol Lindo® (DE); Sotalol-Mepha® (CH); Sotalol NM® (DK); Sotalol NM Pharma® (SE); Sotalolo Hexan® (IT); Sotalolo Merck® (IT); Sotalol ratiopharm® (DE, SE); Sotalol Sandoz® (DE); Sotalol Verla® (DE); sotalol von ct® (DE); Sotamed® (AT); Sotapor® (ES); Sota-Puren® (DE); Sotarit® (DO, TR); Sotaryt® (DE); Sota-saar® (DE); Sotastad® (AT, DE); Sotoger® (IE); Talozin® (TR); Terry White Chemists Sotalol® (AU)


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