Betapace AF 80 mg tablet

Generic name:
Sotalol - oral

Pronunciation
(SO-tuh-lol)

Brand name(s)
Betapace , Betapace AF

Sotalol should be used only in certain patients. Before taking sotalol, discuss the risks and benefits of treatment with your doctor. Although sotalol is effective for treating certain types of fast/irregular heartbeats, it can rarely cause a new serious abnormal heart rhythm (QT prolongation in the EKG). This problem can lead to a new type of abnormal (possibly fatal) heartbeat (torsade de pointes). If this new serious heart rhythm occurs, it is usually when sotalol treatment is first started or when the dose is increased. To reduce the risk of this side effect, you should begin sotalol treatment in a hospital so your doctor can monitor your heart rhythm for several days and treat the problems if they occur. Patients usually start with a low dose of sotalol. Your doctor will then slowly increase your dose depending on how you respond to the medication and how well your kidneys work. If you respond well to this medication, during this time in the hospital your doctor can determine the right dose of sotalol for you.

Some sotalol products are used to treat certain types of fast/irregular heartbeats (atrial fibrillation/flutter). These products come with additional written information from the manufacturer for patients with atrial fibrillation/flutter. If you have these conditions, read the provided information carefully. Do not switch brands of sotalol without checking with your doctor.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Some people who have suddenly stopped taking similar drugs have had chest pain, heart attack, and irregular heartbeat. If your doctor decides you should no longer use this drug, your doctor may direct you to gradually decrease your dose over 1 to 2 weeks.

When gradually stopping this medication, it is recommended that you temporarily limit physical activity to decrease strain on the heart. Get medical help right away if you develop: chest pain/tightness/pressure, chest pain spreading to the jaw/neck/arm, unusual sweating, trouble breathing, fast/irregular heartbeat.

This medication is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

See also Warning section.

Read the Patient Information Leaflet if available from your pharmacist before you start using sotalol and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 1 to 3 to times a day. You may take it with or without food, but it is important to choose one way and take it the same way with each dose.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. Children's dosage is also based on age and body size.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

If you use antacids containing aluminum or magnesium, do not take them at the same time as sotalol. These antacids can bind to sotalol and decrease its absorption and effectiveness. Separate doses of these antacids and sotalol by at least 2 hours to reduce this interaction.

Do not take more of this drug than prescribed because you may increase your risk of side effects, including a new serious abnormal heartbeat. Do not take less of this medication or skip doses unless directed by your doctor. Your fast/irregular heartbeat is more likely to return if you do not take sotalol properly. Also, do not run out of this medication. Order your refills several days early to avoid running out of pills.

Tell your doctor if your condition does not get better or if it gets worse.

See also Warning section.

Tiredness, slow heartbeat, and dizziness may occur. Less common side effects include headache, diarrhea, and decreased sexual ability. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Get medical help right away if you have any very serious side effects, including:

• severe dizziness
• fainting
• sudden change in heartbeat (unusually faster/slower/more irregular)
• chest/jaw/left arm pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• certain heart rhythm problems (such as a slow heartbeat, sick sinus syndrome, second- or third-degree atrioventricular block unless you have a heart pacemaker)
• kidney problems
• heart problems (such as heart failure, recent heart attack)
• breathing problems (such as asthma, chronic bronchitis, emphysema)
• overactive thyroid disease (hyperthyroidism)
• serious allergic reactions needing treatment with epinephrine

Sotalol may cause a condition that affects the heart rhythm (QT prolongation in the EKG). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sotalol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (QT prolongation in the EKG, history of torsade de pointes)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills"), if you are unable to eat or drink fluids as you normally would, or if you have conditions such as severe/prolonged sweating, diarrhea, or vomiting. Talk to your doctor about using sotalol safely.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). The risk is higher if you have diabetes, or are vomiting, fasting, or not eating regularly. Other symptoms of low blood sugar level, such as dizziness and sweating, are not affected by this drug.

If you have diabetes, this product may make it harder to control your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Children may be at greater risk for low blood sugar (hypoglycemia) while using this drug, especially if they are vomiting or not eating regularly. To help prevent low blood sugar, make sure children eat regularly. If your child cannot eat regularly, is vomiting, or has symptoms of low blood sugar (such as sweating, shaking), tell the doctor right away.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, tiredness, and QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also How to Use and Precautions sections.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• fingolimod

Many drugs besides sotalol may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, disopyramide, dofetilide, pimozide, procainamide, quinidine, macrolide antibiotics (such as clarithromycin, erythromycin), among others.

Some products have ingredients that could raise your heart rate. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

This medication may interfere with certain medical/lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe dizziness, fainting, unusually slower/faster/more irregular heartbeat, shortness of breath.

Do not share this medication with others.

Lab and/or medical tests (such as EKG, kidney function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.