Sotalol Tablets (Betapace)

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, BETAPACE AF, Sorine

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

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

• Diabetes
• Heart or vessel disease like slow heart rate, worsening heart failure, heart block, sick sinus syndrome or Raynaud's disease
• Kidney disease
• Liver disease
• History of low levels of potassium or magnesium
• Lung or breathing disease, like asthma or emphysema
• Pheochromocytoma
• Recent heart attack
• Thyroid disease
• An unusual or allergic reaction to sotalol, other beta blockers, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication suddenly. This could lead to serious heart-related effects.

Talk to your care team regarding the use of this medication in children. Special care may be needed. While this medication may be used in 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:

• Amoxapine
• Arsenic trioxide
• Certain antibiotics like gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, sparfloxacin, telithromycin
• Cisapride
• Droperidol
• Haloperidol
• Hawthorn
• Maprotiline
• Medications for malaria like chloroquine and halofantrine
• Medications to control heart rhythm
• Methadone
• Pentamidine
• Phenothiazines like prochlorperazine, perphenazine, thioridazine
• Pimozide
• Ranolazine
• Tricyclic antidepressants like amitriptyline, imipramine, nortriptyline
• Vardenafil

This medication may also interact with the following:

• Antacids
• Certain antibiotics such as clarithromycin and erythromycin
• Clonidine
• Digoxin
• Medications for angina or high blood pressure
• Medications for colds and breathing difficulties
• Medications for diabetes
• Other beta blockers like atenolol, metoprolol, propranolol
• Ziprasidone

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?

Visit your care team for regular checks on your progress. Check your heart rate and blood pressure regularly while you are taking this medication. Ask your care team what your heart rate and blood pressure should be, and when you should contact them. Your care team also may schedule regular blood tests and electrocardiograms to check your progress.

Because your condition and the use of this medication carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and care team.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can make you more drowsy and dizzy. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or pain while you are taking this medication without asking your care team for advice. Some ingredients may increase your blood pressure.

If you are going to have surgery, tell your care team that you are 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's—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
• Worsening mood, feelings of depression

Side effects that usually do not require medical attention (report 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 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

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.