Betapace AF Tablet

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved February 2000

Specific Treatments:

For the prolongation of time to recurrence of symptomatic AFIB/AFL

Therapeutic Areas

General Information

Betapace AF is a medication for the treatment of atrial fibrillation/flutter (AFIB/AFL) in patients with symptomatic AFIB/AFL, with or without structural heart disease but in the absence of uncompensated congestive heart failure. This drug will help maintain the heart in sinus rhythm.

Clinical Results

Two primary studies of Betapace were conducted in patients with symptomatic AFIB/AFL. The first of these studies investigated patients with primarily paroxysmal AFIB/AFL. No structural heart disease was present in 43% of the patients. Patients were given either one or two doses daily, depending on renal function. Results indicated that the drug prolonged the time to the first symptomatic recurrence of AFIB/AFL and also reduced the risk of recurrence at six and twelve months. The 120 mg dose was shown to be more effective than the 80 mg dose. However, there were no significant differences between the 160 mg and 120 mg doses.

The second study investigated patients whose AFIB/AFL was chronic. Structural heart disease was present in 49% of the patients. All patients had chronic AFIB for more than two weeks and less than one year. Results showed that compared to a placebo, there was a longer time to recurrence of AFIB and there was a reduced risk of recurrence at six months.

Further trials also investigated the effect of Betapace's active ingredient, sotalol, on post- myocardial infarction (MI) patients. The drug did not significantly decrease the mortality rate in patients taking the drug, compared to a placebo. However, the investigation determined that there was no increased risk for post-MI patients receiving the drug.

In eight clinical trials with a total of 659 patients, there were four cases of torsade de pointes (TdP), a serious and dangerous ventricular arrhythmia.

Side Effects

Betapace AF can cause serious ventricular arrhythmias, primarily torsade de pointes (TdP). Patients taking this drug should be monitored carefully with electrocardiogram.

Side effects may include:

  • Bradycardia
  • Fatigue
  • Fainting
  • Dizziness
  • Tachycardia
  • Severe diarrhea
  • Unusual sweating
  • Vomiting
  • Decreased appetite
  • Increased thirst

Contraindications to Betapace AF include:

  • chronic renal failure
  • chronic lung disease (such as asthma, chronic bronchitis, or emphysema)
  • heart failure
  • bradycardia

Mechanism of Action

Betapace AF (sotalol hydrochloride) has both beta-andrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Betapace AF (sotalol hydrochloride) is a racemic mixture of d- and l-sotalol. Both isomers have similar Class III antiarrhythmic effects, while the l-isomer is responsible for virtually all of the beta-blocking activity. The beta-blocking effect of sotalol is non-cardioselective, half maximal at about 80 mg/day and maximal at doses between 320 and 360 mg/day. Sotalol does not have partial agonist or membrane stabilizing activity. Although significant beta-blockade occurs at oral doses as low as 25 mg, significant Class III effects are seen only at daily doses of 160 mg or above.

Additional Information

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