Betapace

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.

• 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.

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.

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

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.

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.

• 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.

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.

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.

Tell your healthcare provider if you are pregnant or plan to become pregnant. You should not take Betapace or Betapace AF during pregnancy unless your healthcare provider considers it essential.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. These medications pass into breastmilk. You should not breastfeed while taking this medication.

• Store Betapace and Betapace AF tablets at 25°C (77°F).
• Keep out of sight and reach of children.

Active ingredient: sotalol hydrochloride

Inactive ingredients:

Betapace: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue color #2 (aluminum lake, conc.).

Betapace AF: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.