Sotalol Oral Solution

• If you have an allergy to sotalol or any other part of sotalol oral solution.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Asthma or other lung or breathing problems that cause shortness of breath or wheezing, heart failure (weak heart), certain types of abnormal heartbeats called heart block or sick sinus syndrome, or a slow heartbeat.
• If you have any of these health problems: Low potassium or magnesium levels.
• If you are taking any drugs used for a heartbeat that is not normal.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

This is not a list of all drugs or health problems that interact with sotalol oral solution.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take sotalol oral solution. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need an ECG before starting sotalol oral solution and during treatment. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine may hide the signs of low blood sugar. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, loose stools (diarrhea), not hungry, or more thirst.
• Do not stop taking sotalol oral solution all of a sudden. If you do, chest pain that is worse and in some cases heart attack may occur. The risk may be greater if you have certain types of heart disease. To avoid side effects, you will want to slowly stop this medicine as ordered by your doctor. Call your doctor right away if you have new or worse chest pain or if other heart problems occur.
• This medicine may make it harder to tell if you have signs of an overactive thyroid like fast heartbeat. If you have an overactive thyroid and stop taking sotalol oral solution all of a sudden, it may get worse and could be life-threatening. Talk with your doctor.
• If you have had a very bad allergic reaction, talk with your doctor. You may have a chance of an even worse reaction if you come into contact with what caused your allergy. If you use epinephrine to treat very bad allergic reactions, talk with your doctor. Epinephrine may not work as well while you are taking this medicine.
• The chance of side effects may be higher in female patients. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using sotalol oral solution while you are pregnant.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure.
• Fast or slow heartbeat.
• A new or worse heartbeat that does not feel normal.
• Feeling very tired or weak.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Sweating a lot.
• Change in eyesight.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Loose stools (diarrhea).
• Upset stomach or throwing up.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Do not take this medicine with any of the following medications:

• amoxapine
• arsenic trioxide
• certain antibiotics like gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, sparfloxacin, telithromycin
• cisapride
• droperidol
• haloperidol
• hawthorn
• maprotiline
• medicines for malaria like chloroquine and halofantrine
• medicines to control heart rhythm
• methadone
• pentamidine
• phenothiazines like prochlorperazine, perphenazine, thioridazine, and others
• pimozide
• ranolazine
• tricyclic antidepressants like amitriptyline, imipramine, nortriptyline, and others
• vardenafil
• ziprasidone

This medicine may also interact with the following medications:

• antacids
• certain antibiotics such as clarithromycin and erythromycin
• clonidine
• digoxin
• medicines for angina or high blood pressure
• medicines for colds and breathing difficulties
• medicines for diabetes
• other beta-blockers like atenolol, metoprolol, propranolol and others

Take this medicine by mouth. Follow the directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly. This could lead to serious heart-related effects.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this medicine may be used in children for selected conditions precautions do apply.

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
• history of low levels of potassium or magnesium
• kidney disease
• liver disease
• lung or breathing disease, like asthma or emphysema
• pheochromocytoma
• recent heart attack
• thyroid disease
• an unusual or allergic reaction to sotalol, other beta-blockers, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

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.

Visit your doctor or health care professional for regular checks on your progress. Check your heart rate and blood pressure regularly while you are taking this medicine. Ask your doctor or health care professional what your heart rate and blood pressure should be, and when you should contact him or her. Your doctor or health care professional also may schedule regular blood tests and electrocardiograms to check your progress.

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

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug 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 medicine without asking your doctor or health care professional for advice. Some ingredients may increase your blood pressure.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.