Betapace Consumer Drug Information

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

Because you have irregular heartbeats (atrial fibrillation) that are troublesome to you, BETAPACE has been prescribed to help your heart to beat in a more normal way. However, in some patients BETAPACE 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 .

Clinical studies using BETAPACE 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 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 in a hospital or another place where your heartbeat can be watched closely by healthcare professionals for the first few days. They can help you if problems occur. When BETAPACE 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 , 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:

• faint
• become dizzy
• have fast heartbeats

If you cannot reach your doctor, go to the nearest hospital emergency room. Take your BETAPACE 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
• vomiting
• less appetite than normal
• 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 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 ?"

Once your doctor finds the right dose for you, always take that exact amount of BETAPACE . Never take an extra dose and never skip a dose of BETAPACE .

You can now save hundreds of dollars by buying your Betapace prescription on our online Canadian Drug Store

PRECAUTIONS

RENAL IMPAIRMENT: BETAPACE® (sotalolhydro chloride) is mainly eliminated via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of BETAPACE®.

What is BETAPACE ?

BETAPACE 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 may help your heart stay beating regularly for a longer period of time.

This information about BETAPACE 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 ?

BETAPACE 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 and whether your symptoms are troublesome enough for you to start taking BETAPACE .

Do not take BETAPACE 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 physically active or exercising, and swelling of the ankles or legs)
• have less appetite than normal
• have a very slow heartbeat and do not have an implanted artificial pacemaker

Taking certain other medicines with BETAPACE 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 ?" 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 healthcare 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 in pregnant women. Some reports indicate that BETAPACE is passed into breast milk. Women who are taking BETAPACE should not breastfeed a child.

OVERDOSE

The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycemia. In cases of massive intentional overdosage (2-16 grams) of BETAPACE® the following clinical findings were seen: hypotension, bradycardia, cardiac asystole, prolong ation of QT interval, torsade de pointes, ventricular tachycardia, and premature ventricular complexes. If overdosage occurs, therapy with BETAPACE® should be discontinued and the patient observed closely. Because of the lack of protein binding, hemodialysis is useful for reducing sotalolplasma concentrations. Patients should be carefully observed until QT intervals are normalized and the heart rate returns to levels >50 bpm. In addition, if required, the following therapeutic measures are suggested:

Bradycardia or Cardiac Asystole:
Atropine, another anticholinergic drug, a beta-adrenergic agonist or transvenous cardiac pacing.
Heart Block:
(second and third degree) transvenous cardiac pacemaker.
Hypotension:
(depending on associated factors) epinephrine rather than isoproterenol or norepinephrine may be useful.
Bronchospasm:
Aminophylline or aerosol beta-2-receptor stimulant.
Torsade de pointes:

DC cardioversion, transvenous cardiac pacing, epinephrine, magnesium sulfate.

David's Canadian Drug Store Tells You What To Consider - Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For the beta-blockers, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to the beta-blocker medicine prescribed. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Use of some beta-blockers during pregnancy has been associated with low blood sugar, breathing problems, a lower heart rate, and low blood pressure in the newborn infant. Other reports have not shown unwanted effects on the newborn infant. Animal studies have shown some beta-blockers to cause problems in pregnancy when used in doses many times the usual human dose. Before taking any of these medicines, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether bisoprolol, carteolol, or penbutolol passes into breast milk. All other beta-blockers pass into breast milk. Problems such as low blood sugar, slow heartbeat, low blood pressure, and trouble in breathing have been reported in nursing babies. Mothers who are taking beta-blockers and who wish to breast-feed should discuss this with their doctor.

Children—Some of these medicines have been used in children and, in effective doses, have not been shown to cause different side effects or problems in children than they do in adults.

Older adults—Some side effects are more likely to occur in the elderly, who are usually more sensitive to the effects of beta-blockers. Also, beta-blockers may reduce tolerance to cold temperatures in elderly patients.

David's Canadian Drug Store Explains
How should I take BETAPACE ?
Put a checkmark on your calendar each time you take a dose. This will help you keep track of your doses.

Your doctor will start you on BETAPACE in the hospital and will check your heart rhythm for the first two 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 dose unless your doctor tells you to. Your doctor will do regular tests to check that the amount you’re taking is still right for you.

Keep taking your BETAPACE until your doctor tells you to stop. Keep taking it even if you feel fine. However, never take an extra dose of BETAPACE even if you do not feel well. When it is time to stop taking BETAPACE , your doctor will give you instructions on how to gradually reduce your dose over a period of one to two weeks.

You may take BETAPACE with or without food. However, it is important to take BETAPACE at the same time every day. This gives your heart a steady supply of the medicine. It might be helpful to take BETAPACE 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 two hours after your dose of BETAPACE before you take the antacid.

Never try to make up for a missed dose of BETAPACE . You could increase your chance of getting the different type of abnormal heartbeat. If you miss taking a dose of BETAPACE , just take your normal amount at the next scheduled time.

If you take more BETAPACE 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 tablets with you to show to the doctor or nurse.

David's Canadian Drug Store Tells You
What should you avoid while taking BETAPACE ?

Certain other medicines taken with BETAPACE may increase the chance that you will get the dangerous abnormal heartbeat (see "Who should not take BETAPACE ?") Do not take BETAPACE with these medicines. Before you start taking BETAPACE tell your doctor about all prescription and non-prescription medicines you are taking (see also "Who should not take BETAPACE ?"). Once you begin taking BETAPACE , 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 healthcare providers, tell them you are taking BETAPACE 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 before you have an operation or dental surgery. BETAPACE can affect how well some anesthetics work.

David's Canadian Drug Store Lets You Know The

Proper Use of This Medicine
For patients taking the extended-release capsule or tablet form of this medicine:

Swallow the capsule or tablet whole.
Do not crush, break (except metoprolol succinate extended-release tablets, which may be broken in half), or chew before swallowing.

For patients taking the concentrated oral solution form of propranolol :

This medicine is to be taken by mouth even though it comes in a dropper bottle. The amount you should take is to be measured only with the specially marked dropper.
Mix the medicine with some water, juice, or a carbonated drink. After drinking all the liquid containing the medicine, rinse the glass with a little more liquid and drink that also, to make sure you get all the medicine.
If you prefer, you may mix this medicine with applesauce or pudding instead.
Mix the medicine immediately before you are going to take it. Throw away any mixed medicine that you do not take immediately. Do not save medicine that has been mixed.

Ask your doctor about checking your pulse rate before and after taking beta-blocking agents. If your doctor tells you to check your pulse regularly while you are taking this medicine, and it is much slower than the rate your doctor has designated, check with your doctor. A pulse rate that is too slow may cause circulation problems.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

For patients taking this medicine for high blood pressure :

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. However, if high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Remember that this medicine will not cure your high blood pressure but it does help control it. It is very important that you take your medicine exactly as directed , even if you feel well. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life . Also, it is very important to keep your appointments with your doctor, even if you feel well.

David's Canadian Drug Store Explains

What are the possible side effects of BETAPACE ?

BETAPACE’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 ?" Dangerous abnormal heartbeats happen rarely. But they can be serious and, in rare instances, can even cause death.

BETAPACE ’s most common side effects are tiredness, slow heart rate, shortness of breath, and dizziness. BETAPACE can also cause other side effects. If you are concerned about these or any other side effects, ask your doctor.

David's Canadian Drug Store Warns

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Breathing difficulty and/or wheezing; cold hands and feet; mental depression; shortness of breath; slow heartbeat (especially less than 50 beats per minute); swelling of ankles, feet, and/or lower legs

Rare

Back pain or joint pain; chest pain; confusion (especially in elderly patients); dark urine—for acebutolol, bisoprolol, or labetalol; dizziness or lightheadedness when getting up from a lying or sitting position; fever and sore throat; hallucinations (seeing, hearing, or feeling things that are not there); irregular heartbeat; red, scaling, or crusted skin; skin rash; unusual bleeding and bruising; yellow eyes or skin—for acebutolol, bisoprolol, or labetalol

Signs and symptoms of overdose (in the order in which they may occur)

Slow heartbeat; dizziness (severe) or fainting; fast or irregular heartbeat; difficulty in breathing; bluish-colored fingernails or palms of hands; convulsions (seizures)

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Decreased sexual ability; dizziness or lightheadedness; drowsiness (slight); trouble in sleeping; unusual tiredness or weakness

Less common or rare

Anxiety and/or nervousness; changes in taste—for labetalol only; constipation; diarrhea; dry, sore eyes; frequent urination—for acebutolol and carteolol only; itching of skin; nausea or vomiting; nightmares and vivid dreams; numbness and/or tingling of fingers and/or toes; numbness and/or tingling of skin, especially on scalp—for labetalol only; stomach discomfort; stuffy nose

Although not all of the side effects listed above have been reported for all of these medicines, they have been reported for at least one of them. Since all of the beta-adrenergic blocking agents are very similar, any of the above side effects may occur with any of these medicines. However, they may be more or less common with some agents than with others.

After you have been taking a beta-blocker for a while, it may cause unpleasant or even harmful effects if you stop taking it too suddenly. After you stop taking this medicine or while you are gradually reducing the amount you are taking, check with your doctor right away if any of the following occur:

Chest pain; fast or irregular heartbeat; general feeling of discomfort or illness or weakness; headache; shortness of breath (sudden); sweating; trembling

For patients taking labetalol :

You may notice a tingling feeling on your scalp when you first begin to take labetalol. This is to be expected and usually goes away after you have been taking labetalol for a while.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

David's Canadian Drug Store Tells You

Important points about BETAPACE

BETAPACE 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 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 until your doctor tells you to stop.

David's Canadian Drug Store - Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, some beta-blockers are used in certain patients with the following medical conditions:

Glaucoma

Neuroleptic-induced akathisia (restlessness or the need to keep moving caused by some medicines used to treat nervousness or mental and emotional disorders)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.