An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias. .
An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias. .
What You Should Know About BETAPACE AF™
(Bay tah pace)
(generic name:sotalol hydrochloride)
|This summary contains important patient information that has been reviewed and approved by the U.S. Food and Drug Administration. This summary is not meant to take the place of your doctors instructions. Read this patient information carefully before you start taking BETAPACE AF™. Each time you get a refill, you will receive patient information. Be sure to read it because it may contain new information that you need to know.|
What is the most important information I should know about BETAPACE AF™?
Because you have irregular heartbeats (atrial fibrillation) that are troublesome to you, BETAPACE AF™ has been prescribed to help your heart to beat in a more normal way. However, in some patients BETAPACE AF™ can cause a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death. You may feel this different type of abnormal heartbeat as a fast beating of the heart with lightheadedness and fainting. The possibility of this different type of abnormal heartbeat is the reason you and your doctor have discussed whether your symptoms are troublesome enough for you to start taking BETAPACE AF™.
Clinical studies using BETAPACE AF™ have shown that the most important way to decrease your chance of getting this different type of dangerous abnormal heartbeat is for you to take the dose of BETAPACE AF™ that is right for you. If this abnormal heartbeat occurs, it usually happens during the first few days of treatment. This is why you should be started on BETAPACE AF™ in a hospital or another place where your heartbeat can be watched closely by health care professionals for the first few days. They can help you if problems occur. When BETAPACE AF™ is started this way, this different type of abnormal heartbeat is rare and the hospital staff is there to treat it.
It is important that when you go home, you take the exact dose the doctor prescribed for you. At any time while you are taking BETAPACE AF™, watch for signs that you may be getting this different type of abnormal heartbeat and call your doctor if they occur. Call your doctor right away if you:
• become dizzy, or
• have fast heartbeats.
If you cannot reach your doctor, go to the nearest hospital emergency room. Take your BETAPACE AF™ tablets with you and show them to the doctor or nurse.
Also, call your doctor right away if you have any of the following conditions:
• severe diarrhea
• unusual sweating
• less appetite than normal, or
• more thirst than normal.
These are conditions that will make you more likely to get the different type of abnormal heartbeat.
If you take BETAPACE AF™ with certain other medicines, you will increase your chance of getting this different type of abnormal heartbeat. These medicines are listed below under "Who should not take BETAPACE AF™?"
Once your doctor finds the right dose for you, always take that exact amount of BETAPACE AF™. Never take an extra dose and never skip a dose of BETAPACE AF™.
What is BETAPACE AF™?
BETAPACE AF™ is a medicine that is given to patients with atrial fibrillation (irregular heartbeats). Atrial fibrillation happens when certain parts of the heart (the chambers known as atria) beat too fast or irregularly. When this happens, your heart cannot pump blood through your body as well as it should. This may make you feel weak and tired, or get out of breath easily. You may get an uncomfortable feeling in your chest and "fluttering" or "palpitations." Atrial fibrillation can be changed back (converted) to normal heart rhythm by an electric shock or by using certain medicines. However, atrial fibrillation can return. BETAPACE AF™ may help your heart stay beating regularly for a longer period of time.
This information about BETAPACE AF™ was developed to ensure that you and your doctor get the right information about your type of irregular heartbeats. Consult your doctor before you accept any other sotalol product that does not provide this patient information.
Who should not take BETAPACE AF™?
BETAPACE AF™ is not for everyone with irregular heartbeats (atrial fibrillation). This is why you and your doctor need to discuss the benefits and risks of BETAPACE AF™ and whether your symptoms are troublesome enough for you to start taking BETAPACE AF™.
Do not take BETAPACE AF™ if you:
• have serious kidney problems or are on kidney dialysis;
• have lung disease causing shortness of breath (such as asthma, chronic bronchitis or emphysema);
• have symptoms of heart failure (such as shortness of breath when you exercise or are physically active and swelling of the ankles or legs);
• have a very slow heart beat and do not have an implanted artificial pacemaker;
Taking certain other medicines with BETAPACE AF™ can increase the chance that you will get the dangerous abnormal heartbeat discussed in "What is the most important information I should know about BETAPACE AF™?" These include medicines used to treat abnormal heart rhythms and some other heart problems as well as medicines used to treat depression and other mental problems, night-time heartburn, asthma and infections. Therefore, you should be sure to tell your health care provider about all prescription and non-prescription medicines you are taking, as well as vitamins, dietary supplements, and any natural or herbal remedies. In addition, tell your doctor about any problems you have with your heart or kidneys.
If you are pregnant, you should know that there is no information about the safety of BETAPACE AF™ in pregnant women. Some reports indicate that BETAPACE AF™ is passed into the breast milk. Women who are taking BETAPACE AF™ should not breast feed a child.
How should I take BETAPACE AF™?
Your doctor will start you on BETAPACE AF™ in the hospital and will check your heart rhythm for the first 2 or more days of treatment. This will allow your doctor to find the right dose for you. Always take the exact amount your doctor prescribes. Never change your BETAPACE AF™ dose unless your doctor tells you to. Your doctor will do regular tests to check that the amount youre taking is still right for you.
Keep taking your BETAPACE AF™ until your doctor tells you to stop. Keep taking it even if you feel fine. However, never take an extra dose of BETAPACE AF™ even if you do not feel well. When it is time to stop taking BETAPACE AF™, your doctor will give you instructions on how to gradually reduce your dose over a period of 1 to 2 weeks.
You may take BETAPACE AF™ with or without food. However, it is important to take BETAPACE AF™ at the same time every day. This gives your heart a steady supply of the medicine. It might be helpful to take BETAPACE AF™ at the same time as something you regularly do every day.
If you are taking an antacid containing aluminum or magnesium to treat heartburn or upset stomach wait at least 2 hours after your dose of BETAPACE AF™ before you take the antacid.
Never try to make up for a missed dose of BETAPACE AF™. You could increase your chance of getting the different type of abnormal heartbeat. If you miss taking a dose of BETAPACE AF™, just take your normal amount at the next scheduled time.
If you take more BETAPACE AF™ than you should have, call your doctor right away. If you cannot reach your doctor, go to the nearest hospital emergency room. Take your BETAPACE AF™ tablets with you to show to the doctor or nurse.
What should I avoid while taking BETAPACE AF™?
Certain other medicines taken with BETAPACE AF™ may increase the chance that you will get the dangerous abnormal heartbeat. Do not take BETAPACE AF™ with these medicines. Before you start taking BETAPACE AF™ tell your doctor about all prescription and nonprescription medicines you are taking. Once you begin taking BETAPACE AF™, do not start taking any new medicines until you check with your doctor.
Carry a list of all the medicines and supplements you take. If you have to go to the hospital or are treated by new or different health care providers, tell them you are taking BETAPACE AF™ and show them the list of other medicines you take. They need this information to make sure your medicines are safe to take at the same time.
Tell your doctor or dentist you are taking BETAPACE AF™ before you have an operation or dental surgery. BETAPACE AF™ can affect how well some anesthetics work.
What are the possible side effects of BETAPACE AF™?
BETAPACE AF™s most serious side effect, a different type of dangerous abnormal heartbeat, is discussed in "What is the most important information I should know about BETAPACE AF™?" Dangerous abnormal heartbeats happen rarely. But they can be serious and, in rare instances, can even cause death.
BETAPACE AF™s most common side effects are tiredness, slow rate, shortness of breath, and dizziness. BETAPACE AF™ can also cause other side effects. If you are concerned about these or any other side effects, ask your doctor.
Important points about BETAPACE AF™
BETAPACE AF™ can help you best if you take it as your doctor has prescribed it.
• Take your medicine every day as prescribed.
• Do not miss doses or take extra doses.
• Call your doctor right away if you feel new fast heartbeats with lightheadedness and fainting. These can be serious and in rare instances can even cause death.
• Do not take BETAPACE AF™ if you have serious kidney problems, lung disease causing shortness of breath, symptoms of heart failure.
• Tell your doctor and pharmacist the name of all medications (prescription, non-prescription, and natural/herbal remedies) you are taking.
• Do not start taking any other medicines without telling your doctor.
• Go for all your regular checkups.
• Get your refills on time.
• Do not stop taking BETAPACE AF™ until your doctor tells you to stop.
This leaflet provides a summary of information about BETAPACE AF™. Your doctor or pharmacist has a longer leaflet written for healthcare professionals that you can ask to read. BETAPACE AF™ was prescribed for your particular condition. Do not use it for another condition or give it to others.
Drugs undergoing CYP450 metabolism
Betapace is primarily eliminated by renal excretion; therefore, drugs that are metabolized by CYP450 are not expected to alter the pharmacokinetics of sotalol.
Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; it is not clear whether this represents an interaction or is related to the presence of CHF, a known risk factor for proarrhythmia, in the patients receiving digoxin.
Calcium blocking drugs
BETAPACE AF™ should be administered with caution in conjunction with calcium blocking drugs because of possible additive effects on atrioventricular conduction or ventricular function. Additionally, concomitant use of these drugs may have additive effects on blood pressure, possibly leading to hypotension.
Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients treated with BETAPACE AF™ plus a catecholamine depletor should therefore be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.
Insulin and oral antidiabetics
Hyperglycemia may occur, and the dosage of insulin or antidiabetic drugs may require adjustment. Symptoms of hypoglycemia may be masked.
Beta-agonists such as salbutamol, terbutaline and isoprenaline may have to be administered in increased dosages when used concomitantly with BETAPACE AF™.
Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, caution is advised when discontinuing clonidine in patients receiving BETAPACE AF™.
No pharmacokinetic interactions were observed with hydrochlorothiazide or warfarin.
Administration of BETAPACE AF™ within 2 hours of antacids containing aluminum oxide and magnesium hydroxide should be avoided because it may result in a reduction in Cmax and AUC of 26% and 20%, respectively and consequently in a 25% reduction in the bradycardic effect at rest. Administration of the antacid two hours after BETAPACEAF™ has no effect on the pharmacoki-netics or pharmacodynamics of sotalol.
Drug/Laboratory Test Interactions
The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by fluorimetric or photometric methods. In screening patients suspected of having a pheochromocytoma and being treated with sotalol, a specific method, such as a high performance liquid chromato-graphic assay with solid phase extraction (e.g., J. Chromatogr. 385:241, 1987) should be employed in determining levels of catecholamines.
BETAPACE AF™ (sotalol hydrochloride) is contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present), congenital or acquired long QT syndromes, baseline QT interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/L), creati-nine clearance <40 mL/min, bronchial asthma and previous evidence of hypersensitivity to sotalol.