Betapace AF

Last updated on RxList: 6/21/2021
Betapace AF Side Effects Center

What Is Betapace AF?

Betapace AF (sotalol hydrochloride) is a beta-blocker used to help keep the heart beating normally in people with heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Betapace AF is used in people with atrial fibrillation or atrial flutter. Another form of this medicine, called Betapace (sotalol), is used to treat heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Betapace is used in people with ventricular tachycardia or ventricular fibrillation. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for. Betapace AF is available in generic form.

What Are Side Effects of Betapace AF?

Common side effects of Betapace AF include:

Tell your doctor if you have unlikely but serious side effects of Betapace AF including:

  • new or worsening symptoms of heart failure (such as swelling ankles or feet, severe tiredness, shortness of breath, or unexplained or sudden weight gain).

Dosage for Betapace AF

The dose of Betapace AF is determined by a physician based on clinical factors.

What Drugs, Substances, or Supplements Interact with Betapace AF?

Betapace AF may interact with clonidine, digoxin, reserpine, diuretics (water pills), drugs that can affect heart rhythm, other heart rhythm medications, antibiotics, medicines to treat psychiatric disorders, phenothiazines, antidepressants, diabetes medications, calcium channel blockers, medicine for asthma or other breathing disorders. Tell your doctor all medications you use.

Betapace AF During Pregnancy or Breastfeeding

During pregnancy, Betapace AF should be used only when prescribed. It may harm a fetus. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Additional Information

Our Betapace AF (sotalol hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Atrial fibrillation is a(n) ... See Answer
Betapace AF Consumer Information

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • slow heartbeats;
  • a light-headed feeling, like you might pass out;
  • trouble breathing;
  • severe diarrhea or vomiting, loss of appetite;
  • dry mouth, unusual sweating, increased thirst; or
  • swelling, rapid weight gain.

Common side effects may include:

  • slow heartbeats;
  • feeling weak or tired;
  • dizziness; or
  • cough, trouble breathing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Betapace AF (Sotalol Hcl)

SLIDESHOW

Heart Disease: Causes of a Heart Attack See Slideshow
Betapace AF Professional Information

SIDE EFFECTS

During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral sotalol, of whom 2451 received the drug for at least two weeks. The most important adverse effects are Torsade de Pointes and other serious new ventricular arrhythmias (see WARNINGS), occurring at rates of almost 4% and 1%, respectively, in the VT/VF population. Overall, discontinuation because of unacceptable side-effects was necessary in 17% of all patients in clinical trials, and in 13% of patients treated for at least two weeks. The most common adverse reactions leading to discontinuation of sotalol are as follows: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%.

Occasional reports of elevated serum liver enzymes have occurred with sotalol therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of sotalol and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study. Elevated blood glucose levels and increased insulin requirements can occur in diabetic patients.

The following table lists as a function of dosage the most common (incidence of 2% or greater) adverse events, regardless of relationship to therapy and the percent of patients discontinued due to the event, as collected from clinical trials involving 1292 patients with sustained VT/VF.

Incidence (%) of Adverse Events and Discontinuations DAILY DOSE

Incidence (%) of Adverse Events and Discontinuations
DAILY DOSE
Body System 160 mg
(n=832)
240 mg
(n=263)
320 mg
(n=835)
480 mg
(n=459)
640 mg
(n=324)
Any Dosea
(n=1292)
% Patients Discontinued
(n=1292)
Body as a whole
infection 1 2 2 2 3 4 < 1
fever 1 2 3 2 2 4 < 1
localized pain 1 1 2 2 2 3 < 1
Cardiovascular
dyspnea 5 8 11 15 15 21 2
bradycardia 8 8 9 7 5 16 2
chest pain 4 3 10 10 14 16 < 1
palpitation 3 3 8 9 12 14 < 1
edema 2 2 5 3 5 8 1
ECG abnormal 4 2 4 2 2 7 1
hypotension 3 4 3 2 3 6 2
proarrhythmia < 1 < 1 2 4 5 5 3
syncope 1 1 3 2 5 5 1
heart failure 2 3 2 2 2 5 1
presyncope 1 2 2 4 3 4 < 1
peripheral vascular disorder 1 2 1 1 2 3 < 1
cardiovascular disorder 1 < 1 2 2 2 3 < 1
vasodilation 1 < 1 1 2 1 3 < 1
AICD discharge < 1 2 2 2 2 3 < 1
hypertension < 1 1 1 1 2 2 < 1
Nervous
fatigue 5 8 12 12 13 20 2
dizziness 7 6 11 11 14 20 1
asthenia 4 5 7 8 10 13 1
light-headed 4 3 6 6 9 12 1
headache 3 2 4 4 4 8 < 1
sleep problem 1 1 5 5 6 8 < 1
perspiration 1 2 3 4 5 6 < 1
altered consciousness 2 3 1 2 3 4 < 1
depression 1 2 2 2 3 4 < 1
paresthesia 1 1 2 3 2 4 < 1
anxiety 2 2 2 3 2 4 < 1
mood change < 1 < 1 1 3 2 3 < 1
appetite disorder 1 2 2 1 3 3 < 1
stroke < 1 < 1 1 1 < 1 1 < 1
Digestive
nausea/vomiting 5 4 4 6 6 10 1
diarrhea 2 3 3 3 5 7 < 1
dyspepsia 2 3 3 3 3 6 < 1
abdominal pain < 1 < 1 2 2 2 3 < 1
colon problem 2 1 1 < 1 2 3 < 1
flatulence 1 < 1 1 1 2 2 < 1
Respiratory
pulmonary problem 3 3 5 3 4 8 < 1
upper respiratory tract problem 1 1 3 4 3 5 < 1
asthma 1 < 1 1 1 1 2 < 1
Urogenital
genitourinary disorder 1 0 1 1 2 3 < 1
sexual dysfunction < 1 1 1 1 3 2 < 1
Metabolic
abnormal lab value 1 2 3 2 1 4 < 1
weight change 1 1 1 < 1 2 2 < 1
Musculoskeletal
extremity pain 2 2 4 5 3 7 < 1
back pain 1 < 1 2 2 2 3 < 1
Skin and Appendages
rash 2 3 2 3 4 5 < 1
Hematologic
bleeding 1 < 1 1 < 1 2 2 < 1
Special Senses
visual problem 1 1 2 4 5 5 < 1
a Because patients are counted at each dose level tested, the Any Dose column cannot be determined by adding across the doses.

In an unblinded multicenter trial of 25 patients with SVT and/or VT receiving daily doses of 30, 90 and 210 mg/m² with dosing every 8 hours for a total of 9 doses, no Torsade de Pointes or other serious new arrhythmias were observed. One (1) patient, receiving 30 mg/m² daily, was discontinued because of increased frequency of sinus pauses/bradycardia. Additional cardiovascular AEs were seen at the 90 and 210 mg/m² daily dose levels. They included QT prolongations (2 patients), sinus pauses/bradycardia (1 patient), increased severity of atrial flutter and reported chest pain (1 patient). Values for QTC ≥ 525 msec were seen in 2 patients at the 210 mg/m² daily dose level. Serious adverse events including death, Torsade de Pointes, other proarrhythmias, high-degree A-V blocks and bradycardia have been reported in infants and/or children.

Potential Adverse Effects

Foreign marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, incoordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritis, alopecia.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been associated with sotalol during investigational use and foreign marketing experience.

Read the entire FDA prescribing information for Betapace AF (Sotalol Hcl)

© Betapace AF Patient Information is supplied by Cerner Multum, Inc. and Betapace AF Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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