Sotalol Hydrochloride

Sotalol is a beta-blocker that affects the heart and circulation within the atrium and ventricles (the upper and lower chambers of the heart that allow blood to flow into and out of the heart).

Sotalol is used to help keep the heart beating normally in people with certain heart rhythm disorders, such as atrial fibrillation, atrial flutter, ventricular tachycardia, and ventricular fibrillation.

Sotalol may also be used for purposes not listed in this medication guide.

You should not use sotalol if you are allergic to it, or if you have:

• a serious heart condition such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker);
• long QT syndrome (in you or a family member);
• severe heart failure;
• slow heartbeats that have caused you to faint;
• asthma or other breathing disorder;
• very low levels of potassium in your blood; or
• (if you take sotalol for atrial fibrillation or atrial flutter) severe kidney disease;

Do not give this medicine to a child without medical advice.

Tell your doctor if you have ever had:

• kidney disease (or if you are on dialysis);
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• congestive heart failure;
• coronary artery disease (hardened arteries);
• breathing problems such as bronchitis or emphysema;
• a thyroid disorder;
• diabetes (using sotalol can make it harder for you to tell when you have low blood sugar);
• a severe allergic reaction.

Tell your doctor if you are pregnant.

You should not breastfeed while using sotalol.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Sotalol oral is taken by mouth. Sotalol injection is given as an infusion into a vein. A healthcare provider will give you this injection if you are unable to take the medicine by mouth.

You will receive your first few doses of sotalol in a hospital setting where your heart can be monitored in case the medicine causes serious side effects.

If you already take heart rhythm medication, you may need to stop taking it when you start using sotalol. Carefully follow your doctor's instructions.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Sotalol doses are based on age and body surface area (height and weight) in children. Your child's dose needs may change if the child gains or loses weight, or is still growing.

Call your doctor if you are sick with vomiting or diarrhea, or if you have increased thirst, decreased appetite, or are sweating more than usual. You can easily become dehydrated while taking sotalol. This can lead to very low blood pressure, a serious electrolyte imbalance, or kidney failure.

You will need frequent medical tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). You may also need heart function tests for 1 to 2 weeks after your last dose.

Keep using this medicine as directed, even if you feel well. You may need to take sotalol for the rest of your life.

Do not skip doses or stop using sotalol without your doctor's advice. Stopping suddenly may make your condition worse. Follow your doctor's instructions about tapering your dose.

If you need surgery, tell your surgeon you currently use this medicine.

Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

Your pharmacist may prepare an oral suspension (liquid) form of sotalol. Keep the suspension at room temperature and throw away suspension any left over after 3 months of use.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of sotalol can be fatal.

Avoid taking an antacid within 2 hours before or 2 hours after you take sotalol. Some antacids can make it harder for your body to absorb sotalol.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;
• fast or pounding heartbeats, fluttering in your chest;
• sudden dizziness (like you might pass out);
• slow heartbeats (especially if you feel light-headed);
• swelling, rapid weight gain; or
• feeling short of breath.

Common side effects may include:

• slow heartbeats;
• trouble breathing;
• dizziness; or
• feeling weak or tired.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• other heart medications;
• blood pressure medication; or
• insulin or oral diabetes medicine.

This list is not complete. Other drugs may affect sotalol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your doctor or pharmacist can provide more information about sotalol.