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Betapace

Generic name: sotalol hydrochloride
Brand names: Betapace, Betapace AF
Dosage form: oral tablet
Drug classes: Group III antiarrhythmics, Non-cardioselective beta blockers

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 23, 2023.

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:

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.

Important information

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:

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

Who should not take Betapace and Betapace AF?

Do not take Betapace or Betapace AF if you have:

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:

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

How should I take Betapace and Betapace AF?

What happens if I miss a dose?

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.

What happens if I overdose?

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.

What should I avoid while taking Betapace and Betapace AF?

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.

Dosing information

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

What are the side effects of Betapace and Betapace AF?

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

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.

Interactions

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:

Pregnancy and breastfeeding

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.

Storage

What are the ingredients in Betapace and Betapace AF?

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.

Popular FAQ

Betapace and Betapace AF are essentially the same but they differ in their appearance and approved uses:

  • Betapace is a light-blue tablet and Betapace AF is a white tablet.
  • Betapace is approved for the treatment of life-threatening ventricular arrhythmias, while Betapace AF is approved for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.
  • Both tablets contain the same active ingredient called sotalol.
Continue reading

Sotalol AF is specifically used for maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Plain Sotalol is not approved for AFIB/AFL indication and should not be substituted for Sotalol AF because only Sotalol AF is distributed with a patient package insert that is appropriate for patients with AFIB/AFL. Continue reading

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.