Sotalol

What is Sotalol?

Sotalol

• Sotalol (Betapace) is an antiarrhythmic used to treat and prevent abnormal heart rhythms.

What are the uses of this medicine?

Sotalol (Betapace) is used for:

• the treatment of life-threatening ventricular arrhythmias.
• the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL).

Limitations of Use:

• Sotalol hydrochloride has not been shown to enhance survival in patients with life threatening ventricular arrhythmias.
• Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL.

Sotalol-based-on-HCl-xtal-3D-sf

How does this medicine work?

• The hydrochloride salt form of sotalol, an ethanolamine derivative with class iii antiarrhythmic and antihypertensive properties.
• Sotalol hydrochloride is a nonselective beta adrenergic receptor and potassium channel antagonist.
• In the heart, this agent inhibits chronotropic and inotropic effects thereby slowing the heart rate and decreasing myocardial contractility.
• This agent also reduces sinus rate, slows conduction in the atria and in the atrioventricular (av) node and increases the functional refractory period of the av node.
• In the lungs, sotalol inhibits vasodilation and bronchodilation.
• In addition, this agent inhibits renin release.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present
• Congenital or acquired long QT syndromes
• [[Cardiogenic shock] or decompensated heart failure
• Serum potassium <4 mEq/L
• Bronchial asthma or related bronchospastic conditions
• Hypersensitivity to sotalol

Sotalol ball-and-stick

For the treatment of atrial fibrillation or flutter (AFIB/AFL), sotalol hydrochloride/sotalol hydrochloride AF is also contraindicated in patients with:

• Baseline QT interval >450 msec

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• medications for migraine headaches, diabetes, asthma, allergies, colds, or pain
• medications for high blood pressure or heart disease
• reserpine
• vitamins

if you are taking aluminum- or magnesium-containing antacids (Maalox, Mylanta), take them at least 2 hours before or after sotalol.

Is this medicine FDA approved?

• Sotalol was first described in 1964 and came into medical use in 1974.
• It is available as a generic medication.
• In 2020, it was the 296th most commonly prescribed medication in the United States, with more than 1 million prescriptions.

How should this medicine be used?

Recommended dosage: Adult Dose for Ventricular Arrhythmias:

• The recommended initial dose is 80 mg twice daily.
• This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec.

Adult Dose for Prevention of Recurrence of AFIB/AFL:

• The recommended initial dose is 80 mg twice daily.
• This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec.

For Children Aged About 2 Years and Older:

• For initiation of treatment, 1.2 mg/kg three times a day (3.6 mg/kg total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults.
• Subsequent titration to a maximum of 2.4 mg/kg three times a day can then occur.

For Children Aged About 2 Years or Younger:

• The initial starting dose would be 0.8 mg/kg, administered three times daily.

Administration:

• Sotalol comes as a tablet to take by mouth.
• Sotalol (Betapace) is usually taken twice a day and sotalol (Betapace AF) is usually taken once or twice a day.
• Take sotalol consistently, either with food or without food each time.
• Sotalol controls your condition but does not cure it.
• Continue to take sotalol even if you feel well.
• Do not stop taking sotalol without talking to your doctor.
• If sotalol is stopped suddenly, it may cause chest pain or heart attack.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 80 mg, 120 mg and 160 mg and 240 mg tablets

This medicine is available in fallowing brand namesː

• Betapace
• Betapace AF
• Sorine

What side effects can this medication cause?

The most common side effects of this medicine include:

• fatigue
• bradycardia
• dyspnea
• proarrhythmia
• asthenia
• dizziness

What special precautions should I follow?

• Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation. If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.
• To minimize the risk of drug-induced arrhythmia, initiate or reinitiate oral sotalol in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sotalol.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• Advise patients to avoid taking sotalol hydrochloride/sotalol hydrochloride AF tablets within two hours of taking antacids that contain aluminum oxide or magnesium hydroxide.
• Advise patients that they should not miss a dose, but if they do miss a dose they should not double the next dose to compensate for the missed dose: they should take the next dose at the regularly scheduled time.
• Sotalol produces significant reductions in both systolic and diastolic blood pressures and may result in hypotension. Monitor hemodynamics in patients with marginal cardiac compensation.
• New onset or worsening heart failure may occur during initiation or uptitration of sotalol because of its beta- blocking effects. Monitor for signs and symptoms of heart failure and discontinue treatment if symptoms occur.
• Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery.
• Avoid abrupt withdrawal of beta-blockade in patients with thyroid disease because it may lead to an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Beta-blockade may mask certain clinical signs (for example, tachycardia) of hyperthyroidism.
• Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms or cardiac palpitations.
• Advise patients to contact their healthcare provider in the event of conditions that could lead to electrolyte changes such as severe diarrhea, unusual sweating, vomiting, less appetite than normal, or excessive thirst.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• bradycardia
• congestive heart failure
• hypotension
• bronchospasm
• hypoglycemia
• hypotension
• bradycardia
• cardiac asystole
• prolongation of QT interval
• Torsade de Pointes
• ventricular tachycardia
• premature ventricular complexes

Management of overdosage:

• If overdosage occurs, therapy with sotalol should be discontinued and the patient observed closely.
• Because of the lack of protein binding, hemodialysis is useful for reducing sotalol plasma concentrations.
• Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm.

In addition, if required, the following therapeutic measures are suggested:

• Bradycardia or Cardiac Asystole: Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
• Heart Block: transvenous cardiac pacemaker.
• Hypotension: epinephrine rather than isoproterenol or norepinephrine may be useful.
• Bronchospasm: Aminophylline or aerosol beta-2-receptor stimulant. Higher than normal doses of beta-2-receptor stimulants may be required.
• Torsade de Pointes: DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.

Can this medicine be used in pregnancy?

• Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate.

Can this medicine be used in children?

• The safety and effectiveness of sotalol in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• SOTALOL HYDROCHLORIDE

Inactive ingredients:

• MAGNESIUM STEARATE
• MICROCRYSTALLINE CELLULOSE

Who manufactures and distributes this medicine?

Distributed by:

• American Health Packaging
• Columbus, OH

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Sotalol
• FDA Sotalol

List of antiarrhythmic agents:

• Amiodarone
• Disopyramide
• Dofetilide
• Dronedarone
• Flecainide
• Ivabradine
• Mexiletine
• Procainamide
• Propafenone
• Quinidine