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Sotalol

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Warning

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.

Precautions

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.

Side Effects

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.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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