Sotylize (Sotalol Hydrochloride) for Heart Rhythm Problems

Sotylize (sotalol hydrochloride) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat certain serious heart rhythm problems.

How Sotylize Works and How It’s Taken

Sotylize is an anti-arrhythmic medicine. It blocks beta receptors and changes the heart’s electrical activity. These effects can slow the heart rate and help prevent abnormal heart rhythms.

Doctors prescribe Sotylize to treat life-threatening ventricular arrhythmias. They also prescribe it to help delay the return of highly symptomatic atrial fibrillation or atrial flutter in people who are already in a normal heart rhythm.

Sotylize is a liquid taken by mouth. Treatment must be started or restarted in a medical facility that can provide continuous electrocardiogram (ECG) monitoring and cardiac resuscitation. Do not stop taking Sotylize or change your dose without talking with your healthcare provider.

Typical Dosing for Heart Rhythm Problems

Adults with life-threatening ventricular arrhythmias

The usual starting dose is 80 milligrams two times a day. A doctor may raise the total daily dose by 80 milligrams every three days if the QTc interval remains below 500 milliseconds. Most people respond to a total of 160 to 320 milligrams each day, divided into two or three doses.

Higher doses may be used when serious heart rhythms do not improve with usual treatment.

Adults with atrial fibrillation or atrial flutter

Treatment should not be started if the QTc interval is greater than 450 milliseconds.

Children about age 2 and older with normal kidney function

The starting dose is 1.2 milligrams per kilogram of body weight three times a day. A doctor may slowly raise the dose to no more than 2.4 milligrams per kilogram three times a day. There should be at least 36 hours between dose increases.

Children age 2 and younger

The dose is lowered based on the child’s age. For example, a 1-month-old child may receive 0.8 milligrams per kilogram three times a day. A baby about 1 week old may receive 0.4 milligrams per kilogram three times a day.

People with kidney problems

People with kidney problems may need more time between doses based on how well their kidneys work. They need close monitoring, and the dose should not be raised until at least five doses have been given on the correct schedule.

This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Sotylize Side Effects

In clinical studies, common side effects occurred in about 2 percent to 20 percent of people. These include:

Bradycardia (slow heart rate)
Fatigue (tiredness)
Dizziness
Dyspnea (shortness of breath)
Proarrhythmia (new or worsened abnormal heart rhythms)
Asthenia (weakness)
Diarrhea
Nausea and vomiting
Hyperhidrosis (excessive sweating)
Headache

Serious Side Effects and Warnings

Sotylize can cause serious side effects that may require immediate medical attention. These include:

Life-threatening proarrhythmia — Sotylize can cause serious and potentially fatal ventricular arrhythmias, primarily torsade de pointes, a fast heart rhythm associated with QT prolongation.
QT prolongation — Changes in the heart’s electrical timing can trigger dangerous abnormal rhythms.
Bradycardia and heart block — The heart may beat too slowly, or electrical signals may not travel normally through the heart.
Hypotension — Blood pressure can fall too low.
New or worsening heart failure — The heart may not pump as well, especially when treatment starts or the dose increases.
Bronchospasm — The airways can tighten, making breathing difficult.
Severe or prolonged hypoglycemia — Low blood sugar can occur, especially in people with diabetes, children, and people who are fasting or vomiting. Sotylize can also mask early warning signs such as tachycardia (fast heartbeat).
Severe allergic reactions — Anaphylaxis can be harder to treat while taking a beta-blocker.
Worsening hyperthyroidism after abrupt withdrawal — Stopping Sotylize suddenly can worsen hyperthyroidism and may trigger thyroid storm.
Cardiac ischemia after abrupt withdrawal — Angina or a heart attack may occur after Sotylize is stopped suddenly, especially in people with ischemic heart disease.

Get medical help right away if you think you are having a serious reaction.

What To Know Before Taking Sotylize

Before starting Sotylize, your doctor will:

Use an ECG to check your heart rhythm and QT interval
Measure your potassium and magnesium levels and correct them if needed
Check how well your kidneys work

Tell your doctor if you are allergic to sotalol or any ingredient in Sotylize. Also tell your doctor if you have heart problems, kidney problems, asthma, other breathing problems, or a history of severe allergic reactions.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Do not take Sotylize within two hours of antacids that contain aluminum oxide or magnesium hydroxide.

Do not take Sotylize if you have:

A baseline QT interval greater than 450 milliseconds
A very slow heartbeat, sick sinus syndrome, or certain types of heart block without a working pacemaker
Congenital or acquired long QT syndrome
Cardiogenic shock or decompensated heart failure
A blood potassium level below 4 mEq/L
Bronchial asthma or a related breathing condition
An allergy to sotalol

Kidney problems do not always prevent treatment, but your doctor may give Sotylize less often and monitor you closely.

If you miss a dose, take the next dose at the usual time. Do not take two doses at once or take doses closer together.

If you are pregnant, planning to become pregnant, or breastfeeding, talk with your doctor about the risks and benefits. Sotylize passes into breast milk and may harm your baby. Do not breastfeed while taking Sotylize.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Sotylize for heart rhythm problems?

In studies of people who had already returned to a normal heart rhythm, sotalol helped delay the return of atrial fibrillation or atrial flutter.

In one 12-month study, the abnormal rhythm returned in 49 percent of people taking 120 milligrams two times a day and 42 percent taking 160 milligrams two times a day, compared with 67 percent of people taking placebo (an inactive treatment). The median time before the rhythm returned was 229 days, 175 days, and 27 days, respectively.

In another six-month study conducted after cardioversion, 45 percent of people taking sotalol remained in a normal heart rhythm without a recurrence, compared with 29 percent taking placebo. The median time before recurrence was more than 180 days with sotalol and 44 days with placebo.

How long does Sotylize take to reach steady levels?

After a dose, Sotylize reaches its highest blood level in about 2.5 to 4 hours. It usually takes about two to three days of regular dosing to reach a steady level in the body. The prescribing information does not say exactly when a person will notice an improvement in their heart rhythm.

What tests or monitoring are needed with Sotylize for heart disease?

Starting or restarting Sotylize requires at least three days in a hospital or another medical facility, or until steady drug levels are reached. The facility must provide continuous ECG monitoring and be able to provide emergency cardiac care.

Before starting treatment, your doctor will:

Use an ECG to check your QT interval
Measure your potassium and magnesium levels and correct them if needed
Check your kidney function by measuring serum creatinine and calculating creatinine clearance

Your QTc interval should also be checked two to four hours after each dose increase.