Sotalol Tablets (Betapace AF)

What is this medication?

SOTALOL (SOE ta lole) prevents and treats a fast or irregular heartbeat (arrhythmia). It is often used to treat a type of arrhythmia known as AFib (atrial fibrillation). It works by slowing down overactive electric signals in the heart, which stabilizes your heart rhythm. It also lowers your heart rate. It belongs to a group of medications called antiarrhythmics.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BETAPACE AF

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Alcohol use
• Diabetes
• Heart disease
• Heart failure
• High or low levels of electrolytes, such as magnesium or potassium, in your blood
• Irregular heartbeat or rhythm
• Kidney disease
• Low blood pressure
• Lung or breathing disease, such as asthma or COPD
• Slow heartbeat
• Thyroid disease
• An unusual or allergic reaction to sotalol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label. Keep taking it unless your care team tells you to stop.

Take antacids or products containing aluminum oxide and magnesium hydroxide at a different time of day than this medication. Take these products 2 hours before or 2 hours after this medication.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Fingolimod
• Ibutilide
• Ketoconazole
• Levoketoconazole
• Pimozide
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Antacids
• Digoxin
• Medications for diabetes
• Other medications that cause heart rhythm changes

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored closely in the hospital for at least 3 days when you start or re-start this medication. Once you are out of the hospital, visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done before or while taking this medication. Your care team may also give you a test called an electrocardiogram (ECG) to check your heart before and during treatment.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may be slowly lowered over time to avoid any side effects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Talk to your care team right away if you have diarrhea, vomiting, loss of appetite, increased thirst, or if you sweat a lot while taking this medication. A change in the level of electrolytes in your body may make it dangerous for you to take this medication.

If you are going to need surgery or a procedure, tell your care team that you are taking this medication.

This medication may affect blood glucose levels. It can also mask the symptoms of low blood sugar, such as a rapid heartbeat and tremors. If you have diabetes, it is important to check your blood sugar often while you are taking this medication.

Talk to your care team if you may be pregnant. There are benefits and risks to taking medications during pregnancy. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Raynaud syndrome—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Diarrhea
• Dizziness
• Fatigue
• Headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.