Betapace AF (Sotalol Hydrochloride) for Heart Disease

Betapace AF (sotalol hydrochloride) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help maintain a normal heart rhythm in people with atrial fibrillation (AFib) or atrial flutter who have significant symptoms and are already in a normal heart rhythm.

How Betapace AF Works and How It’s Taken

Betapace AF is a type of medication called an antiarrhythmic. It helps control the heart’s rhythm by blocking certain signals that affect heart rate and changing how electrical signals move through the heart. These effects can slow the heart rate and help maintain a normal heart rhythm.

Doctors prescribe Betapace AF to help prevent AFib or atrial flutter from returning in people who have significant symptoms and are already in a normal heart rhythm.

Betapace AF comes as a tablet taken by mouth. How often it is taken depends on how well the kidneys work.

Typical Dosing for Heart Rhythm Problems

The recommended starting dose of Betapace AF for adults is 80 milligrams twice daily.

If needed, a doctor may increase the total daily dose by 80 milligrams every three days, based on the person’s response to treatment and heart monitoring results. Most people respond well to 120 milligrams twice daily.

People with reduced kidney function may need lower doses or more time between doses.

Treatment must be started or restarted in a hospital for at least three days or until the medicine reaches a steady level in the body. During this time, healthcare providers continuously monitor the heart’s electrical activity to check for dangerous changes in heart rhythm.

Your healthcare provider will decide the right dose based on your heart rhythm, kidney function, and heart tests. Do not change your dose or stop taking Betapace AF without medical advice.

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

Betapace AF Side Effects

In clinical studies of Betapace AF, the most common side effects occurred in about 3 percent to 20 percent of people taking the medication, depending on the side effect and dose. These include:

Fatigue
Dizziness
Dyspnea (shortness of breath)
Bradycardia (slow heart rate)
Hyperhidrosis (increased sweating)
Asthenia (weakness)
Nausea or vomiting
Diarrhea
Headache

Serious Side Effects and Warnings

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

QT prolongation and proarrhythmia — Dangerous changes in heart rhythm can include Torsade de Pointes, a life-threatening rhythm.
Bradycardia and heart block — A very slow heart rate or slowed electrical signals in the heart can cause fainting.
Hypotension — Blood pressure may drop while taking Betapace AF.
New or worsening heart failure — The heart may not pump as well, especially when starting or increasing the dose.
Bronchospasm — Tightening of the airways can worsen breathing problems such as asthma, chronic bronchitis, or emphysema.
Low blood sugar or masked low blood sugar symptoms — Hypoglycemia may be harder to recognize in people with diabetes.
Worsening thyroid symptoms after abruptly stopping Betapace AF — Suddenly stopping beta-blockers can worsen symptoms of an overactive thyroid.
Anaphylaxis — This severe allergic reaction may be harder to treat while taking a beta-blocker.

Betapace AF has a boxed warning, the FDA’s strongest safety warning, for some of the serious risks mentioned above. A boxed warning does not mean the drug is unsafe for everyone or that everyone faces the same level of risk.

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

How To Save on Betapace AF

Legacy Pharma offers the Legacy Patient Program, which provides eligible uninsured and underinsured people in the United States with Betapace AF at no cost for up to 12 months per calendar year, subject to prescription, income, residency, and insurance requirements.

You can enter your prescription and dosage details through the program’s online registration portal.

To learn more or apply, visit the Legacy Patient Program website or call 866-435-8080.

What To Know Before Taking Betapace AF

Before starting Betapace AF, your doctor will check:

Your heart’s electrical activity — An electrocardiogram (ECG) measures the QT interval, which shows how long your heart takes to recover between beats.
Your potassium and magnesium levels — Low levels must be corrected before starting treatment.
Your kidney function — Blood tests help your doctor determine the right dosing schedule.

Tell your doctor if you are allergic to sotalol or have had an allergic reaction to Betapace AF.

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

Avoid taking Betapace AF within two hours of antacids that contain aluminum oxide or magnesium hydroxide.

Do not take Betapace AF if you have:

Sinus bradycardia (a very slow heart rate), certain types of heart block, or sick sinus syndrome, unless you have a working pacemaker
Long QT syndrome, a condition that affects the heart’s electrical activity
A potassium level below 4 milliequivalents per liter
Cardiogenic shock, a condition in which the heart cannot pump enough blood to the body
Decompensated heart failure (heart failure that has become worse)
Asthma or similar conditions that cause the airways to narrow
An allergy to sotalol

If you miss a dose, take your next dose at the usual time. Do not take two doses at once or take your next dose earlier than scheduled.

If you are pregnant or planning to become pregnant, talk with your doctor about the possible risks of Betapace AF. Taking sotalol during pregnancy may affect your baby’s heart rate, blood sugar, and heart rhythm.

Do not breastfeed while taking Betapace AF. Sotalol passes into breast milk and may cause serious side effects in your baby.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Betapace AF for heart rhythm problems?

Clinical studies have shown that Betapace AF can help delay the return of AFib or atrial flutter.

In one 12-month study of people with symptomatic AFib or atrial flutter, the median time before the abnormal heart rhythm returned was:

27 days with placebo (a treatment without active medication)
106 days with Betapace AF 80 milligrams
229 days with Betapace AF 120 milligrams
175 days with Betapace AF 160 milligrams

At 12 months, the abnormal heart rhythm had returned in 67 percent of people taking placebo, compared with 58 percent, 49 percent, and 42 percent in the three Betapace AF dose groups.

In a second six-month study of people with chronic AFib, the median time before AFib or atrial flutter returned, or death occurred, was 44 days with placebo and more than 180 days with Betapace AF.

These results show that Betapace AF can help delay the return of abnormal heart rhythms, but results vary from person to person.

How long does Betapace AF take to work for heart rhythm problems?

After taking Betapace AF by mouth, the medication reaches its highest level in the blood within about two and a half to four hours.

The amount of medication in the blood usually reaches a steady level within two to three days, or after about five to six doses when taken twice daily.

However, these times do not tell exactly when a person will notice an improvement. Betapace AF is used to help maintain a normal heart rhythm and delay the return of AFib or atrial flutter.

Does Betapace AF interact with other medicines?

Yes. Betapace AF can interact with certain medications. Some interactions can increase the risk of serious side effects or affect how well the medication works.

Examples include:

Other heart rhythm medications — Certain medications, such as amiodarone, may increase the risk of dangerous changes in the heart’s electrical activity.
Medications that slow the heart rate — Digoxin, diltiazem, verapamil, and other beta-blockers may increase the risk of a slow heart rate or low blood pressure.
Diabetes medications — Insulin and other medications used to lower blood sugar may need dose adjustments.
Certain asthma medications — Medicines such as albuterol may require higher doses when used with Betapace AF.
Clonidine — Taking these medications together can increase the risk of a slow heart rate or problems with electrical signals in the heart.
Certain antacids — Antacids containing aluminum oxide or magnesium hydroxide can reduce how much Betapace AF the body absorbs. Avoid taking them within two hours of Betapace AF.

Tell your healthcare provider about all medications you take, including prescription drugs, over-the-counter medicines, vitamins, and supplements. Do not start or stop medications without medical advice.