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What is the most important information I should know about sotalol?

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

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, you may need to temporarily stop using sotalol. Be sure the surgeon knows ahead of time that you are using sotalol.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is sotalol?

Sotalol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation.

Another form of this medicine, called Sotalol AF, is used to treat heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol may also be used for purposes other than those listed in this medication guide.

Precautions

Do not use this medication if you are allergic to sotalol, or if you have:

  • asthma;
  • certain heart conditions, especially "AV block" (unless you have a pacemaker);
  • a history of "Long QT syndrome"; or
  • severe or uncontrolled congestive heart failure.

Before using sotalol, tell your doctor if you are allergic to any drugs, or if you have:

  • breathing problems such as bronchitis or emphysema;
  • a history of heart disease or congestive heart failure;
  • diabetes;
  • kidney disease;
  • a thyroid disorder;
  • an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or
  • if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use sotalol, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Sotalol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not take an antacid within 2 hours before or after taking sotalol. Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol.

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Instructions

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a sotalol overdose may include slow or fast heartbeats, shortness of breath, chest pain, swelling, hunger, weakness, confusion, sweating, feeling light-headed, fainting, or seizure (convulsions).

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeat, chest pain, shortness of breath;
  • feeling light-headed, fainting;
  • slow heartbeat;
  • unusual sweating, increased thirst; or
  • swelling, rapid weight gain.

Other less serious side effects are more likely to occur, such as:

  • mild diarrhea, nausea, vomiting;
  • headache;
  • sleep problems (insomnia); or
  • tired feeling.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking sotalol, tell your doctor if you are using:

  • clonidine (Catapres);
  • digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);
  • guanethidine (Ismelin);
  • reserpine;
  • a diuretic (water pill);
  • drugs that can affect heart rhythm, such as bepridil (Vascor), cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);
  • any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), sotalol (Betapace);
  • antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);
  • medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);
  • a phenothiazine such as chlorpromazine (Thorazine), mesoridazine (Serentil), thioridazine (Mellaril), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine), trifluoperazine (Stelazine);
  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), trimipramine (Surmontil);
  • a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);
  • a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Procardia, Adalat), nimodipine (Nimotop), nisoldipine (Sular), verapamil (Calan, Covera, Isoptin, Verelan); or
  • medicine for asthma other breathing disorders, such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair).

If you are using any of these drugs, you may not be able to take sotalol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect sotalol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04