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Betapace

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Betapace




Betapace Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/25/2015

Betapace (sotalol) is an antiarrhythmic agent used for treating ventricular arrhythmias. Generic formulations are available. Common side effects of Betapace include headache, indigestion, dizziness, fatigue, weakness, tiredness, slow heart rate, chest pain, palpitations, diarrhea, nausea, vomiting, upset stomach, sleep problems (insomnia), or pain in your arms or legs.

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; difficult breathing; swelling of your face, lips, tongue, or throat.

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

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • feeling like you might pass out;
  • slow heartbeats;
  • trouble breathing;
  • unusual sweating, increased thirst; or
  • swelling, rapid weight gain.

Less serious side effects may include:

  • headache, mild dizziness;
  • feeling weak or tired;
  • mild diarrhea, nausea, vomiting;
  • upset stomach;
  • sleep problems (insomnia); or
  • pain in your arms or legs.

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

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related.

Ventricular Arrhythmias

Serious Adverse Reactions

In patients with a history of sustained ventricular tachycardia, the incidence of Torsade de Pointes during oral sotalol treatment was 4% and worsened VT was about 1%; in patients with other less serious ventricular arrhythmias the incidence of Torsade de Pointes was 1% and new or worsened VT was about 0.7%. Incidence of Torsade de Pointes arrhythmias in patients with VT/VF are shown in Table 3 below.

Table 3: Percent Incidence of Torsade de Pointes and Mean QTc Interval by Dose For Patients With Sustained VT/VF

Daily Dose (mg) Torsade de Pointes Incidence Mean QTc * (msec)
80 0 (69) 463 (17)
160 0.5 (832) 467 (181)
320 1.6 (835) 473 (344)
480 4.4 (459) 483 (234)
640 3.7 (324) 490(185)
> 640 5.8 (103) 512 (62)
( ) Number of patients assessed
*highest on-therapy value

Table 4 below relates the incidence of Torsade de Pointes to on-therapy QTc and change in QTc from baseline in patients with ventricular arrhythmias. It should be noted, however, that the highest on-therapy QTc was in many cases the one obtained at the time of the Torsade de Pointes event, so that the table overstates the predictive value of a high QTc.

Table 4: Relationship Between QTc Interval Prolongation and Torsade de Pointes

On-Therapy QTc Interval (msec) Incidence of Torsade de Pointes Change from Baseline in QTc (msec) Incidence of Torsade de Pointes
< 500 1.3% (1787) < 65 1.6% (1516)
500-525 3.4% (236) 65-80 3.2% (158)
525-550 5.6% (125) 80-100 4.1% (146)
> 550 10.8% (157) 100-130 5.2% (115)
    > 130 7.1% (99)
( ) Number of patients assessed

Table 5: Incidence (%) of Common Adverse Reactions ( ≥ 2% in the Placebo group and less frequent than in the Betapace groups) in a Placebo-controlled Parallel-group Comparison Study of Patients with Ventricular Ectopy

Body System/ Adverse Reaction (Preferred Term) Placebo
N = 37 (%)
Betapace Total Daily Dose
320 mg
N = 38 (%)
640 mg
N = 39 (%)
CARDIOVASCULAR
Chest Pain 5.4 7.9 15.4
Dyspnea 2.7 18.4 20.5
Palpitation 2.7 7.9 5.1
Vasodilation 2.7 0.0 5.1
NERVOUS SYSTEM
Asthenia 8.1 10.5 20.5
Dizziness 5.4 13.2 17.9
Fatigue 10.8 26.3 25.6
Headache 5.4 5.3 7.7
Lightheaded 8.1 15.8 5.1
Sleep Problem 2.7 2.6 7.7
RESPIRATORY
Upper Respiratory Tract Problem 2.7 2.6 12.8
SPECIAL SENSES
Visual Problem 2.7 5.3 0.0

The most common adverse reactions leading to discontinuation of Betapace in trials of patients with ventricular arrhythmias are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. Incidence of discontinuation for these adverse reactions was dose related.

One case of peripheral neuropathy that resolved on discontinuation of Betapace and recurred when the patient was rechallenged with the drug was reported in an early dose tolerance study.

Pediatric Patients

In an unblinded multicenter trial of 25 pediatric 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 prolongation (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.

Atrial Fibrillation/Atrial Flutter

Placebo-controlled Clinical Trials

In a pooled clinical trial population consisting of 4 placebo-controlled studies with 275 patients with atrial fibrillation (AFIB)/atrial flutter (AFL) treated with 160 to 320 mg doses of Betapace AF, the following adverse reactions presented in Table 6 occurred in at least 2% of placebo-treated patients and at a lesser rate than Betapace-treated patients. The data are presented by incidence of reactions in the Betapace AF and placebo groups by body system and daily dose.

Table 6: Incidence (%) of Common Adverse Reactions ( ≥ 2% in the Placebo group and less frequent than in the Betapace AF groups) in Four Placebo-controlled Studies of Patients with AFIB/AFL

Body System/ Adverse Reaction (Preferred Term) Placebo
N = 282 (%)
Betapace AF Total Daily Dose
160-240 mg
N = 153 (%)
> 240-320 mg
N = 122 (%)
CARDIOVASCULAR
Bradycardia 2.5 13.1 12.3
GASTROINTESTINAL
Diarrhea 2.1 5.2 5.7
Nausea/Vomiting 5.3 7.8 5.7
Pain abdomen 2.5 3.9 2.5
GENERAL
Fatigue 8.5 19.6 18.9
Hyperhidrosis 3.2 5.2 4.9
Weakness 3.2 5.2 4.9
MUSCULOSKELETAL/CONNECTIVE TISSUE
Pain musculoskeletal 2.8 2.6 4.1
NERVOUS SYSTEM
Dizziness 12.4 16.3 13.1
Headache 5.3 3.3 11.5
RESPIRATORY
Cough 2.5 3.3 2.5
Dyspnea 7.4 9.2 9.8

Overall, discontinuation because of unacceptable adverse events was necessary in 17% of the patients, and occurred in 10% of patients less than two weeks after starting treatment. The most common adverse reactions leading to discontinuation of Betapace AF were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

Postmarketing Experience

The following adverse drug reactions have been identified during post-approval use of sotalol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Voluntary reports since introduction include 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.

Read the entire FDA prescribing information for Betapace (Sotalol)

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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