CAS: 959-24-0

Melting Point: 206.5-207°C dec

Appearance: White Crystalline Solid

Application Notes:

A potent -adrenergic receptor antagonist. A class III antiarrythmic. It has been shown to prolong action potential and increases the refractory period.

What is the most important information I should know about sotalol?
· Sotalol is not appropriate for everyone with irregular heartbeats. If you have atrial fibrillation (a specific type of irregular heartbeat), you and your doctor should carefully discuss the benefits and risks of sotalol and whether your symptoms are troublesome enough for you to start taking sotalol. In some patients treated with sotalol for atrial fibrillation, sotalol may cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death.
·Do not skip doses, take more doses, change your dosing schedule, or stop taking sotalol without first talking to your doctor. Changing your medication schedule could make your condition worse.
·Call your doctor immediately if you experience shortness of breath, fainting, become dizzy, or have fast heartbeats. If you cannot reach your doctor, go to the nearest hospital emergency room. Also, call your doctor right away if you have severe diarrhea, unusual sweating, vomiting, less appetite than normal, or more thirst than normal.
·Use caution when driving, operating machinery, or performing other hazardous activities. Sotalol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
·Tell your doctor or dentist that you are taking sotalol before you have an operation or dental surgery.
·Betapace and Betapace AF are both products containing sotalol. However, because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information), your doctor will determine which medication is appropriate for your condition.

What is sotalol?
·Sotalol is in a class of drugs called beta-blockers. Beta-blockers affect the heart and circulatory system.
·Sotalol is used to treat irregular heartbeat patterns.
· Sotalol is not appropriate for everyone with irregular heartbeats. If you have atrial fibrillation (a specific type of irregular heartbeat), you and your doctor should carefully discuss the benefits and risks of sotalol and whether your symptoms are troublesome enough for you to start taking sotalol. In some patients treated with sotalol for atrial fibrillation, sotalol may cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death.
· Sotalol may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking sotalol?
· Do not take sotalol without first talking to your doctor if you have
· asthma, chronic bronchitis, emphysema, or any other condition that affects the lungs or causes shortness of breath;
· heart problems such as low blood pressure, a very slow heart rate (and do not have an implanted pacemaker), heart block, sick sinus syndrome, heart failure, recent heart attack, and others;
· kidney disease or are on kidney dialysis;
· diabetes;
· thyroid disease;
·· less appetite than normal;
· a history of anaphylactic reactions; or
· low levels of potassium or magnesium in the blood.
· You may not be able to take sotalol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
· Sotalol is not appropriate for everyone with irregular heartbeats. If you have atrial fibrillation (a specific type of irregular heartbeat), you and your doctor should carefully discuss the benefits and risks of sotalol and whether your symptoms are troublesome enough for you to start taking sotalol. In some patients treated with sotalol for atrial fibrillation, sotalol may cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death.
· Sotalol is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take sotalol without first talking to your doctor if you are pregnant.
· Sotalol passes into breast milk and may affect a nursing infant. Do not take sotalol without first talking to your doctor if you are breast-feeding a baby.

How should I take sotalol?
· Take sotalol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
· Take each dose with water.
· Sotalol can be taken with or without food. The way you take it should be consistent. Either always take it with food or always take it without food. Try to take your doses at the same time each day.
· Do not skip doses, take more doses, change your dosing schedule, or stop taking sotalol without first talking to your doctor. Changing your medication schedule could make your condition worse. When it is time to stop taking sotalol, your doctor will give you instructions on how to gradually reduce your dose over a period of 1 to 2 weeks.
· Betapace and Betapace AF are both products containing sotalol. However, because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information), your doctor will determine which medication is appropriate for your condition.
· Do not take antacids containing aluminum or magnesium (e.g., Rolaids, Maalox, Mylanta, Gelusil, Milk of Magnesia, and others) within 2 hours of a dose of sotalol.
· Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?
· Try not to miss any doses of this medication. Missing doses could be very dangerous.
· If you do miss a dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication. A double dose could be dangerous.

What happens if I overdose?
· Seek emergency medical attention if you have taken more sotalol than was prescribed. Call your doctor right away or if you cannot reach your doctor, go to the nearest hospital emergency room.
· Symptoms of a sotalol overdose include a slow heartbeat, wheezing, shortness of breath, fainting, dizziness, weakness, and confusion.

What should I avoid while taking sotalol?
· Use caution when driving, operating machinery, or performing other hazardous activities. Sotalol may cause drowsiness, dizziness, and blood pressure changes. If you experience drowsiness or dizziness, avoid these activities.
· Do not start to take any other prescription medicines or over-the-counter products (including vitamins, natural supplements, and natural or herbal remedies) without first talking to your doctor or pharmacist.
· Tell your doctor or dentist that you are taking sotalol before you have an operation or dental surgery.

What are the possible side effects of sotalol?
· Call your doctor immediately if you experience shortness of breath, fainting, become dizzy, or have fast heartbeats. If you cannot reach your doctor, go to the nearest hospital emergency room. Also, call your doctor right away if you have severe diarrhea, unusual sweating, vomiting, less appetite than normal, or more thirst than normal.
· If you experience any of the following serious side effects, stop taking sotalol and contact your doctor immediately or seek emergency medical treatment:
· an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; hives);
· wheezing or shortness of breath;
·· dizziness or fainting;
· a slow or fast heartbeat;
· swelling of the feet and lower legs;
· chest (heart) pain;
· severe diarrhea;
· unusual sweating;
· vomiting;
· less appetite than normal;
· more thirst than normal;
· blue or cold feet and hands; or
· a rash.
· If you experience any of the following less serious side effects, continue taking sotalol and talk to your doctor:
· fatigue, weakness, or confusion;
· headache or dizziness;
· nausea;
· depression;
· insomnia (difficulty in falling asleep or staying asleep);
· nightmares; or
· impotence (difficulty obtaining or maintaining an erection).
· 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.

What other drugs will affect sotalol?
· Before taking sotalol, tell your doctor if you are taking any of the following medicines:
· a calcium channel blocker such as amlodipine (Norvasc), bepridil (Vascor), diltiazem (Cardizem, Dilacor XR), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nimodipine (Nimotop), or verapamil (Calan, Verelan, Isoptin);
· disopyramide (Norpace), quinidine (Cardioquin, Quinaglute, Quinidex, others), procainamide (Pronestyl, Procan SR), or amiodarone (Cordarone);
· reserpine, hydralazine (Apresoline, others), guanethidine (Ismelin), guanfacine (Tenex), guanadrel (Hylorel), or guanabenz;
· doxazosin (Cardura), terazosin (Hytrin), or prazosin (Minipress);
· insulin or an oral diabetes medicine such as glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), tolbutamide (Orinase), acetohexamide (Dymelor), or tolazamide (Tolinase);
· a phenothiazine such as chlorpromazine (Thorazine), prochlorperazine (Compazine), promethazine (Phenergan), and others;
· a tricyclic antidepressant such as amitriptyline (Elavil), imipramine (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and others;
· albuterol (Ventolin, Proventil, Volmax, others), terbutaline (Brethine), bitolterol (Tornalate), salmeterol (Serevent), and others;
· clonidine (Catapres);
· digoxin (Lanoxin);
· antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tab, E.E.S., E-Mycin, others), troleandomycin (TAO), sparfloxacin (Zagam), moxifloxacin (Avelox), gatifloxacin (Tequin), and others; or
· cisapride (Propulsid).
· You may not be able to take sotalol, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medications listed above.
· Do not take antacids containing aluminum or magnesium (e.g., Rolaids, Maalox, Mylanta, Gelusil, Milk of Magnesia, and others) within 2 hours of a dose of sotalol.
· Drugs other than those listed here may also interact with sotalol or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines (including vitamins, natural supplements, and natural or herbal remedies).