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Betapace AF

Generic Name: sotalol (SOE-ta-lol)
Brand Name: Betapace AF

Betapace AF may sometimes cause a new or worsened irregular heartbeat (prolonged QT interval), which could be life-threatening. Talk with your doctor if you have prolonged QT interval or kidney problems.

Patients who begin taking or restart Betapace AF should be observed in a hospital or similar setting in which heart and kidney function monitoring may be performed for at least 3 days after starting Betapace AF. Close monitoring of your heart or kidney function may also be needed if your dose is changed.

Do not change from 1 brand, generic version, or form of Betapace AF to another without consulting your doctor. Betapace AF is labeled specifically for atrial fibrillation or atrial flutter.

Betapace AF is used for:

Maintaining a normal heartbeat in patients who have atrial fibrillation or atrial flutter (certain types of abnormal heartbeat).

Betapace AF is an antiarrhythmic medicine. It works by helping the heart beat regularly for a longer period of time.

Do NOT use Betapace AF if:

  • you are allergic to any ingredient in Betapace AF
  • you have certain types of irregular heartbeat (eg, long QT syndrome, prolonged QT interval), shock caused by serious heart problems, uncontrolled heart failure, low blood potassium or magnesium levels, severe kidney problems, or asthma or other lung or breathing problems that cause shortness of breath or wheezing
  • you have a very slow heartbeat or certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree heart block) and you do not have a permanent pacemaker
  • you are taking another medicine that has sotalol in it
  • you are taking certain antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, procainamide, quinidine), a tricyclic antidepressant (eg, amitriptyline), or any other medicine that can cause a certain type of irregular heartbeat (prolonged QT interval). There are many medicines that can do this. Ask your doctor or pharmacist if you are not sure.

Contact your doctor or health care provider right away if any of these apply to you.

Before using Betapace AF:

Some medical conditions may interact with Betapace AF. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have breathing or lung problems (eg, chronic obstructive pulmonary disorder [COPD], an overactive thyroid, kidney problems, diabetes, blood flow problems, or a tumor on your adrenal gland
  • if you have a history of other heart problems (eg, heart failure, slow or irregular heartbeat, a recent heart attack), blood electrolyte problems (eg, low blood potassium or magnesium levels), low blood pressure, problems with the acid or base levels in your body, or episodes of low blood sugar
  • if you have recently taken an antiarrhythmic medicine
  • if you are scheduled for surgery

Some MEDICINES MAY INTERACT with Betapace AF. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Calcium channel blockers (eg, diltiazem, verapamil), clonidine, digoxin, diuretics (eg, furosemide, hydrochlorothiazide), guanethidine, or reserpine because the risk of side effects, such as low blood pressure or heart problems, may be increased
  • Antiarrhythmics (eg, dronedarone, propafenone), macrolides and ketolides (eg, erythromycin), phenothiazines (eg, chlorpromazine, thioridazine), quinolones (eg, ciprofloxacin), or tricyclic antidepressants (eg, amitriptyline) because the risk of abnormal heart rhythms may be increased
  • Beta-agonists (eg, albuterol, isoproterenol, terbutaline), epinephrine (when used to treat allergic reactions), or insulin or other medicines for diabetes (eg, nateglinide) because their effectiveness may be decreased by Betapace AF

This may not be a complete list of all interactions that may occur. Ask your health care provider if Betapace AF may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Betapace AF:

Use Betapace AF as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Betapace AF. Talk to your pharmacist if you have questions about this information.
  • Take Betapace AF by mouth with or without food.
  • Do not take an antacid that has aluminum or magnesium in it within 2 hours before or after you take Betapace AF.
  • Betapace AF works best if it is taken at the same time each day. Taking Betapace AF at the same time each day will also help you remember to take it.
  • Continue to use Betapace AF even if you feel well. Do not miss any doses.
  • A suspension can be made if you cannot swallow Betapace AF. Talk with your doctor or pharmacist.
  • If a suspension has been prepared, shake well before use. Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of Betapace AF, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Betapace AF.

Important safety information:

  • Tell your doctor or dentist that you take Betapace AF before you receive any medical or dental care, emergency care, or surgery.
  • Betapace AF may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Betapace AF with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Betapace AF may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do NOT take more than the recommended dose or change your dose without checking with your doctor.
  • If you have less appetite than normal, increased thirst, severe diarrhea, unusual sweating, or vomiting, talk with your doctor. These may increase the risk of blood electrolyte problems. Electrolyte problems may lead to serious side effects while taking Betapace AF. Talk with your doctor.
  • Do not suddenly stop taking Betapace AF. Sharp chest pain, irregular heartbeat, and, sometimes, heart attack may occur if you suddenly stop Betapace AF. The risk may be greater if you have certain types of heart disease. Heart disease is common and you may not know you have it. Your doctor should slowly lower your dose over several weeks if you need to stop taking it. Limit physical activity while you are lowering your dose. If new or worsened chest pain or other heart problems occur, contact your doctor right away. You may need to start taking Betapace AF again.
  • Diabetes patients - Betapace AF may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Diabetes patients - Betapace AF may hide signs of low blood sugar, such as rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Betapace AF may make it harder to tell if you have symptoms of an overactive thyroid (eg, fast heartbeat). If you have an overactive thyroid and stop taking Betapace AF all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
  • If you have a history of any severe allergic reaction, talk with your doctor. You may be at risk of an even more severe allergic reaction if you come into contact with the substance that caused your allergy. Some medicines used to treat severe allergies may also not work as well while you are taking Betapace AF.
  • Betapace AF may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Betapace AF.
  • You will need to have your blood pressure and heart rate checked often. Talk with your doctor.
  • You will need to have an electrocardiogram (ECG) before starting Betapace AF and during treatment. Talk with your doctor.
  • Use with care in women. They may have a higher risk of serious irregular heartbeat.
  • Lab tests may be performed while you take Betapace AF. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Betapace AF while you are pregnant. Betapace AF is found in breast milk. Do not breast-feed while taking Betapace AF.

Possible side effects of Betapace AF:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or slow heartbeat; irregular heartbeat that is new or worse; severe or persistent dizziness or tiredness; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; unusual sweating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Betapace AF:

Store Betapace AF at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. If a suspension has been prepared, store at room temperature, between 59 and 86 degrees F (15 and 30 degrees C) for up to 3 months. Keep all Betapace AFs out of the reach of children and away from pets.

General information:

  • If you have any questions about Betapace AF, please talk with your doctor, pharmacist, or other health care provider.
  • Betapace AF is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Betapace AF or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Betapace AF. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Betapace AF. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Betapace AF.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.