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Betapace

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Betapace

Betapace Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Betapace (sotalol) is an antiarrhythmic agent used for treating ventricular arrhythmias. Generic formulations are available. Common side effects include dyspnea, dizziness, fatigue, bradycardia, chest pain, palpitations, nausea, and vomiting.

The recommended dose for adults is 80 to 160 mg twice daily. Betapace may interact with amiodarone, ketoconazole, itraconazole, calcium channel blockers, beta-blockers, beta-agonists, tricyclic antidepressants, and antacids containing aluminum or magnesium. Abrupt withdrawal may lead to to myocardial infarction due to catecholamine sensitivity. Betapace has not been adequately evaluated in pregnant women and it is secreted in breast milk.

Our Betapace (sotalol) 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Betapace in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeat, chest pain, shortness of breath;
  • feeling light-headed, fainting;
  • slow heartbeat;
  • unusual sweating, increased thirst; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • mild diarrhea, nausea, vomiting;
  • headache;
  • sleep problems (insomnia); or
  • tired feeling.

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 (Sotalol) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Betapace Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Tiredness, slow heartbeat, and dizziness may occur. Less common side effects include headache, diarrhea, and decreased sexual ability. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening symptoms of heart failure (such as swelling ankles/feet, severe tiredness, shortness of breath, unexplained/sudden weight gain).

Seek immediate medical attention if any of these unlikely but serious side effects occur: severe dizziness, fainting, sudden change in heartbeat (unusually faster/slower/more irregular), chest/jaw/left arm pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Betapace (Sotalol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Betapace FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

During premarketing trials, 3186 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral Betapace (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 Betapace (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 Betapace (sotalol) therapy but no cause and effect relationship has been established. One case of peripheral neuropathy which resolved on discontinuation of Betapace (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

Body System DAILYDOSE
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 Betapace (sotalol) during investigational use and foreign marketing experience.

Read the entire FDA prescribing information for Betapace (Sotalol) »

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Betapace - User Reviews

Betapace User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Betapace sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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