What are Betapace and Betapace AF?

Betapace and Betapace AF are antiarrhythmic drugs, which are a type of drug used to prevent and treat irregular or abnormal heartbeats (arrhythmias). Betapace and Betapace AF both contain the same active ingredient called sotalol.

Betapace and Betapace AF are Class II antiarrhythmic drugs, which are a group of drugs that act as beta blockers, under the Vaughan Williams Classification system. They also have Class III properties as they prolong the action potential duration of heart muscle cells. This increases the effective refractory period (EFP) - or rest period - that the cells have after responding to the electrical charges that signal the muscle cells to contract and enable the heart to pump blood around the body.

Betapace and Betapace AF work by slowing down the electrical signals in your heart, which helps it beat more steadily. They also lower your heat rate and make it easier for your heart to relax, fill with blood and pump that blood around your body.

Betapace was approved by the US Food and Drug Administration (FDA) in 1992 and Betapace AF was approved in 2000. Generic versions of stotalol hydrochloride tablets have since been approved, including one marketed under the brandname Sorine.

What are Betapace and Betapace AF used for?

Betapace and Betapace AF are used for:

• the treatment of life-threatening ventricular arrhythmias
• the maintenance of normal sinus rhythm - keep the heart beating normally - in patient with atrial fibrillation (AFIB) or flutter (AFL)

Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias. Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL.

Betapace and Betapace AF can cause serious side effects including a different type of abnormal heartbeat that can be dangerous, and in rare instances can even cause death. You may feel this abnormal heartbeat as a fast beating of the heart with lightheadedness and fainting. Once your healthcare provider finds the right dose for you, always take that exact amount they prescribe.

If an abnormal heartbeat occurs, it usually happens during the first few days of treatment. This is why you should be started on these medications in a hospital or another place where your heartbeat can be watched closely by health care professionals for the first few days.

When you go home, remember to watch for signs that you may have developed an abnormal heartbeat and call your healthcare provider if they occur. Call your healthcare provider right away if you:

• faint
• become dizzy
• have fast heartbeats
  If you cannot reach your healthcare provider, go to the nearest hospital emergency room.
  
  Also, call your healthcare provider 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 an abnormal heartbeat.

If you take Betapace and Betapace AF with certain other medicines, you will increase your chance of getting an abnormal heartbeat.

• When you first start taking Betapace or Betapace AF it will be administered in a hospital setting by a healthcare professional who will monitor you for about 3 days.
• Always take these medications exactly as your healthcare provider tells you to.
• Do not stop taking these medications suddenly. Talk to your healthcare provider first about the right way to stop taking these medications.
• Take tablets orally twice a day, or as directed.
• Take tablets at the same time every day.
• Take with or without food.

• Adults - ventricular arrhythmias or for prevention of recurrence of AFIB/AFL
  The recommended initial dose of Betapace and Betapace AF in adults is 80 mg twice daily. The dose should be increased in increments of 80 mg/day every 3 days to a maximum of 320 mg total daily dose.
• Pediatric patients - ventricular arrhythmias of AFIB/AFL
  The recommended initial dose for children aged about 2 years and older is 1.2 mg/kg three times a day, which may be increased up to a maximum of 2.4 mg/kg three times a day. The recommended dose in children about 2 years of age and younger is lower and based on the age of the child.

See the Full Prescribing Information for further details about Betapace and Betapace AF dosing.

Do not take Betapace or Betapace AF if you have:

• serious kidney problems or are on kidney dialysis
• symptoms of heart failure (such as shortness of breath when you exercise or are physically active and swelling of the ankles or legs) or cardiogenic shock
• sinus bradycardia (a very slow heart rate), sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present
• congenital or acquired long QT syndromes
• serum potassium <4 mEq/L
• lung disease causing shortness of breath (such as asthma, chronic bronchitis or emphysema)
• hypersensitivity to sotalol, other beta blockers, or any of the ingredients in these medications. See below for a complete list of ingredients.
• been using this treatment for AFIB/AFL and your baseline QT interval is > 450 msec

What should I tell my doctor before taking Betapace or Betapace AF?

Before taking these medications, tell your healthcare provider about all of your medications and medical conditions including if you have:

• kidney or heart problems
• low blood pressure
• lung disease such as chronic bronchitis, emphysema or asthma
• diabetes
• an overactive thyroid
• a history of allergic reactions
• low potassium or magnesium levels in your blood
• a severe or prolonged diarrhea
• a major surgical procedure planned, especially if it involves a general anesthetic

Do not start taking any new medications without talking to your healthcare provider first.

If you miss a dose of Betapace or Betapace AF take the next dose at the usual time. Do not double the dose or shorten the dosing interval.

Remember to get your prescription filled before you run out.

If you take too much Betapace or Betapace AF seek medical attention right away or call the Poison Help line at 1-800-222-1222. Taking too much of these medications can be fatal.

Avoid taking these medications within 2 hours of antacids containing aluminium oxide and magnesium hydroxide.

These medications may make you feel dizzy or tired. If you experience these side effects, avoid driving or operating heavy machinery.

The most common side effects of Betapace and Betapace AF are:

• fatigue
• a heartbeat of less than 50 bpm (bradycardia)
• Shortness of breathe (dyspnea)
• proarrhythmia
• abnormal physical weakness or lack of energy (asthenia)
• dizziness

These are not all of the side effects of these medications. Call your healthcare provider for medical advice about side effects.

To report suspected adverse reactions, contact Covis Pharma at 1-866-488-4423 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other antiarrhythmic drugs
• digoxin
• a calcium channel blocker
• insulin or anti-diabetic medications
• antacids containing aluminum or magnesium.