No

Antiarrhythmic Agent, Class II; Antiarrhythmic Agent, Class III; Beta Blocker, Beta₁ Selective

Treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the prescriber are life-threatening

B

Clinical effects on the fetus: Although there are no adequate and well controlled studies in pregnant women, sotalol has been shown to cross the placenta, and is found in amniotic fluid. There has been a report of subnormal birth weight with sotalol, therefore, sotalol should be used during pregnancy only if the potential benefit outweighs the potential risk.

Bronchial asthma, sinus bradycardia, second and third degree A-V block (unless a functioning pacemaker is present), congenital or acquired long Q-T syndromes, cardiogenic shock, uncontrolled congestive heart failure, and previous evidence of hypersensitivity to sotalol; concurrent use with sparfloxacin. Betapace AF® is contraindicated in patients with significantly reduced renal filtration (Cl_cr <40 mL/minute).

Monitor and adjust dose to prevent QTc prolongation. 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). Avoid abrupt discontinuation in patients with a history of CAD; slowly wean while monitoring for signs and symptoms of 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 cautiously in the renally impaired (dosage adjustment required). Use care with anesthetic agents which decrease myocardial function.

>10%:

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

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

Neuromuscular & skeletal: Weakness (13%)

Respiratory: Dyspnea (21%)

1% to 10%:

Cardiovascular: Congestive heart failure (5%), reduced peripheral circulation, peripheral vascular disorders (3%) (3%), edema (8%), abnormal EKG (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: Decreased sexual ability (3%)

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

Genitourinary: Impotence (2%)

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

Case reports: Leukocytoclastic vasculitis, retroperitoneal fibrosis, bronchiolitis obliterans with organized pneumonia

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 V_d, long half-life or low intrinsic clearance (acebutolol, atenolol, nadolol, sotalol)

Antacids (aluminum/magnesium) decrease sotalol blood levels. Separate by 2 hours.

Cisapride and sotalol increases malignant arrhythmias; concurrent use is contraindicated.

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

Drugs which prolong the QT interval include amiodarone, amitriptyline, astemizole, bepridil, disopyramide, erythromycin, haloperidol, imipramine, quinidine, pimozide, procainamide, and thioridazine. Effect/toxicity may be increased; use with caution.

Sparfloxacin, gatifloxacin, and moxifloxacin may result in additional prolongation of the QT interval; concurrent use is contraindicated.

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 A-V nodal conduction, and increased A-V 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 greater than or equal to 160 mg/day

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

Bioavailability: 90% to 100%

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

Metabolism: Sotalol is not metabolized

Protein binding: Not protein bound

Half-life: 12 hours

Elimination: Unchanged through kidney

Serum concentrations have not been systematically evaluated: Concentration-effect curves for the beta-blocking and antiarrhythmic agents of sotalol are different

Serum levels of 340-3,440 ng/mL have shown a 70% to 100% reduction in PVBs

Average serum concentrations associated with significant Q-T prolongation were 2,550 ng/mL

Average serum concentrations associated with maximum heart reduction by 50% was 804 ng/mL

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.

Supraventricular arrhythmias: 2-4 mg/kg/24 hours was given in 2 equal doses every 12 hours to 18 infants ( less than or equal to 2 months of age). All infants, except one with chaotic atrial tachycardia, were successfully controlled with sotalol. Ten infants discontinued therapy between the ages of 7-18 months when it was no longer necessary. Median duration of treatment was 12.8 months.

Adults: Oral:

Ventricular arrhythmias (Betapace®):

Initial: 80 mg twice daily

Dose may be increased (gradually allowing 2-3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals) to 240-320 mg/day.

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: 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 Cl_cr <40 mL/minute.

Ventricular arrhythmias (Betapace®):

Cl_cr >60 mL/minute: Administer every 12 hours

Cl_cr 10-30 mL/minute: Administer every 24 hours

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

Cl_cr <10 mL/minute: Individualize dose

Atrial fibrillation/flutter (Betapace AF®):

Cl_cr >60 mL/minute: Administer every 12 hours

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

Cl_cr <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

Food decreases absorption; administer on an empty stomach

Food may decrease adsorption

Serum magnesium, potassium, EKG

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.

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

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

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

Noncardioselective beta-blockers (ie, propranolol, nadolol) 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.

Take exactly as directed; do not take additional doses or discontinue without consulting prescriber. You will need regular cardiac checkups and blood tests while taking this medication. You may experience dizziness, drowsiness, or visual changes (use caution when driving or engaging in tasks requiring alertness until response to drug is known); orthostatic hypotension (use caution when climbing stairs or when changing position - rising from lying or sitting position); abnormal taste, nausea or vomiting, or loss of appetite (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); decreased sexual ability (reversible); or constipation (increased exercise, dietary fiber, fruit, or fluid may help). Report chest pain, palpitation, or erratic heartbeat; difficulty breathing or unusual cough; mental depression or persistent insomnia (hallucinations); or changes in vision.

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

Tablet (Betapace®) (light blue): 80 mg, 120 mg, 160 mg, 320 mg

Tablet (Betapace AF®) (white): 80 mg, 120 mg, 160 mg

Fernandes CMB and Daya MR, "Sotalol-Induced Bradycardia Reversed by Glucagon," Can Fam Physician, 1995, 41:659-60, 663-5.

Pill MW and McCloskey WW, "Sotalol: What the Emergency Nurse Needs to Know," J Emerg Nurs, 1995, 21(3):229-31.

Sung RJ, Tan HL, Karagounis L, et al, "Intravenous Sotalol for the Termination of Supraventricular Tachycardia and Atrial Fibrillation and Flutter: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Sotalol Multicenter Study Group," Am Heart J, 1995, 129(4):739-48.