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Sotalol Hydrochloride

Pronouncation: (SOTT-uh-lahl HIGH-droe-KLOR-ide)
Class: Beta-adrenergic blocking agent

Trade Names:
Betapace
- Tablets 80 mg
- Tablets 120 mg
- Tablets 160 mg
- Tablets 240 mg

Trade Names:
Betapace AF
- Tablets 80 mg
- Tablets 120 mg
- Tablets 160 mg

Apo-Sotalol (Canada)
Gen-Sotalol (Canada)
Novo-Sotalol (Canada)
Nu-Sotalol (Canada)
PMS-Sotalol (Canada)
ratio-Sotalol (Canada)
Rhoxal-sotalol (Canada)
Sotacor (Canada)

Pharmacology

Feedback for Sotalol Hydrochloride

As a treatment for...	Avg User Ratings [?]
Atrial Fibrillation	7.0 2 comments Rate it!
Atrial Flutter	Be the first to rate it 0 comments
Ventricular Arrhythmia	Be the first to rate it 1 comments

Compare with other drugs.

Blocks beta receptors, which primarily affect heart (slows rate), vascular musculature (decreases blood pressure), and lungs (reduces function).

Pharmacokinetics

Absorption

Oral bioavailability of sotalol is 90% to 100% and T _max is 2.5 to 4 h. Absorption was reduced approximately 20% compared to fasting when administered with a standard meal. Steady state is reached after 1 to 2 days.

Distribution

Sotalol does not bind to plasma proteins.

Metabolism

Sotalol is not metabolized.

Elimination

Sotalol t _½ is 12 h and it is excreted predominantly via the kidney in unchanged form.

Special Populations

Renal Function Impairment

Lower doses are necessary in renal function impairment.

Hepatic Function Impairment

Patients with hepatic function impairment show no alteration in sotalol clearance.

Indications and Usage

Betapace

Management or prevention of life-threatening ventricular arrhythmias.

Betapace AF

Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter (AFIB/AFL) ( Betapace AF ).

Contraindications

Betapace

Hypersensitivity to beta-blockers; greater than first-degree heart block; CHF unless secondary to tachyarrhythmia treatable with beta-blockers; overt cardiac failure; sinus bradycardia; cardiogenic shock; bronchial asthma or bronchospasm, including severe COPD; congenital or acquired long QT syndromes.

Betapace AF

Sinus bradycardia (less than 50 bpm during waking hours); sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present); congenital or acquired QT syndromes; baseline QT interval greater than 450ߙmsec; cardiogenic shock; uncontrolled heart failure; hypokalemia (less than 4ߙmEq/L); CrCl less than 40ߙmL/min; bronchial asthma; previous evidence of hypersensitivity to sotalol.

Dosage and Administration

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

Betapace
Adults

PO 80 mg twice daily; may increase up to 320 mg/day in 2 or 3ߙdivided doses. Patients with a history of symptomatic AFIB/AFL currently receiving Betapace should be transferred to Betapace AF because of the significant differences in labeling.

Betapace AF

Therapy with Betapace AF must be initiated and, if necessary, titrated in a setting that provides continuous ECG monitoring and in the presence of personnel trained in the management of serious ventricular arrhythmias. Monitor patients in this way for a minimum of 3ߙdays on the maintenance dose and do not discharge within 12 h of electrical or pharmacological conversion to normal sinus rhythm.

Adults

PO Initiate therapy at 80 mg twice daily if CrCl is greater than 60ߙmL/min, and 80 mg once daily if the CrCl is 40 to 60 mL/min. Begin continuous ECG monitoring with QT interval measurements 2 to 4 h after each dose. If the 80ߙmg dose level is tolerated and QT interval remains less than 500 msec after at least 3 days, the patient may be discharged. Alternatively, during hospitalization, if 80 mg level does not reduce the frequency of relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (ie, greater than 520 msec), after following the patient for 3 days, the dose level may be increased to 120 mg (once or twice daily depending on CrCl). The max recommended dose in patients with CrCl greater than 60ߙmL/min is 160 mg twice daily.

Storage/Stability

Store at room temperature.

Drug Interactions

Amiodarone, disopyramide, procainamide, quinidine

May prolong cardiac refractoriness.

Calcium channel blockers

Increased risk of hypotension; possible increased effect on atrioventricular conduction or ventricular function.

Clonidine

May enhance or reverse antihypertensive effects; may enhance clonidine rebound hypertension.

Gatifloxacin, moxifloxacin, sparfloxacin

Do not use in patients receiving sotalol because of increased risk of life-threatening cardiac arrhythmias.

Guanethidine, reserpine

Increased hypotension or bradycardia.

Insulin, oral sulfonylurea hypoglycemic agents

Hyperglycemia; symptoms of hypoglycemia may be masked.

NSAIDs

Some agents may impair antihypertensive effect.

Laboratory Test Interactions

May interfere with glucose or insulin tolerance tests, may result in falsely elevated urinary levels of metanephrine.

Adverse Reactions

Cardiovascular

Arrhythmias; sustained ventricular tachycardia or fibrillation; torsades de pointes.

CNS

Depression; dizziness; headache; lethargy; paresthesias; vivid dreams.

Dermatologic

Rash.

GI

Anorexia; constipation; diarrhea; dry mouth; dyspepsia; flatulence; nausea; vomiting.

Genitourinary

Decreased libido; dysuria; impotence; nocturia; urinary retention or frequency; urinary tract infection.

Hematologic

May increase or decrease blood glucose.

Hepatic

Elevated liver enzymes.

Respiratory

Bronchospasm; difficulty breathing; wheezing.

Precautions

Warnings

Equipped facility

To minimize risk of induced arrhythmia, initiate or re-initiate therapy for at least 3 days in facility that can provide cardiac resuscitation and EKG monitoring.

Do not substitute Betapace for Betapace AF . Betapace does not have an atrial fibrillation indication or package insert information for patient.

Pregnancy

Category B .

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Renal Function

Alteration of dosage interval and reduced daily dose are advised.

Hepatic Function

Alteration of dosage interval and reduced daily dose are advised.

Abrupt withdrawal

Has been associated with adverse effects; gradually decrease dose over 1 to 2 wk.

Anaphylaxis

Deaths have occurred; aggressive therapy may be required.

CHF

Administer cautiously in patients with CHF controlled by digitalis and diuretics.

Diabetic patients

Drug may mask signs and symptoms of hypoglycemia (eg, tachycardia, BP changes). Drug may potentiate insulin-induced hypoglycemia.

Nonallergic bronchospasm

Give drug with caution in patients with bronchospastic disease.

Peripheral vascular disease

May precipitate or aggravate symptoms of atrial insufficiency.

Proarrhythmia

May provoke new or worsened arrhythmias. Correct hypokalemia or hypomagnesemia before administering sotalol. Anticipate proarrhythmic events with initial dose and with every dose adjustment.

Thyrotoxicosis

May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm.

Overdosage

Symptoms

Bradycardia, CHF, hypotension, bronchospasm, prolongation of QT interval, torsades de pointes, ventricular tachycardia, premature ventricular complexes, hypoglycemia.

Patient Information

Explain importance of not discontinuing drug suddenly, and advise that dosage will be decreased over 1 to 2 wk.
Explain that drug may mask signs and symptoms of hypoglycemia.
Teach patient to take pulse daily and to notify health care provider if pulse is less than 60.
Tell patient to call health care provider if adverse reaction occurs.