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Betapace AF

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Betapace AF

Betapace AF Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Betapace AF (sotalol hydrochloride) is 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. It is a beta-blocker. This medication is available in generic form. Common side effects include tiredness, slow heartbeat, and dizziness. Less common side effects include headache, diarrhea, and decreased sexual ability.

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

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.

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 AF 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;
  • heartburn, stomach pain, loss of appetite;
  • joint or muscle pain; or
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough.

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) »

What is Patient Information Overview?

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

Betapace AF 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 AF (Sotalol Hcl)»

What is Prescribing information?

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

Betapace AF FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse events that are clearly related to BETAPACE AF (sotalol hcl) are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects. The common documented beta-blocking adverse events (bradycardia, dyspnea, and fatigue) and Class III effects (QT interval prolongation) are dose related.

In a pooled clinical trial population consisting of four placebocontrolled studies with 275 patients with AFIB/AFL treated with 160-320 mg doses of BETAPACE AF, the following adverse events were reported at a rate of 2% or more in the 160-240 mg treated patients and greater than the rate in placebo patients (See Table 8). The data are presented by incidence of events in the BETAPACE AF and placebo groups by body system and daily dose. No significant irreversible non-cardiac end-organ toxicity was observed.

Table 8: Incidence (%) of Common Adverse Events ( ≥ 2% in the 160-240 mg group and more frequent than on placebo) in Four Placebo-Controlled Studies of Patients with AFIB/AFL

Body System/Adverse Event
(Preferred Term)
Placebo
N=282
BETAPACE AF Total Daily Dose
160-240
N=153
>240-320
N=122
CARDIO VASCULAR
  Abnormality ECG 0.4 3.3 2.5
  Angina Pectoris 1.1 2.0 1.6
  Bradycardia 2.5 13.1 12.3
  Chest Pain Cardiac/Non-Anginal 4.6 4.6 2.5
  Disturbance Rhythm Atrial 2.1 2.0 1.6
  Disturbance Rhythm Subjective 9.9 9.8 7.4
GASTROINTESTINAL
  Appetite Decreased 0.4 2.0 1.6
  Diarrhea 2.1 5.2 5.7
  Distention Abdomen 0.4 0.7 2.5
  Dyspepsia/Heartburn 1.8 2.0 2.5
  Nausea/Vomiting 5.3 7.8 5.7
  Pain Abdomen 2.5 3.9 2.5
GENERAL
  Fatigue 8.5 19.6 18.9
  Fever 0.7 0.7 3.3
  Hyperhidrosis 3.2 5.2 4.9
  Influenza 0.4 2.0 0.8
  Sensation Cold 0.7 2.0 2.5
  Weakness 3.2 5.2 4.9
MUSCULOSKELETAL/CONNECTIVE TISSUE
  Pain Chest Musculoskeletal 1.4 2.0 2.5
  Pain Musculoskeletal 2.8 2.6 4.1
NERVOUS SYSTEM
  Dizziness 12.4 16.3 13.1
  Headache 5.3 3.3 11.5
  Insomnia 1.1 2.6 4.1
RESPIRATORY
  Cough 2.5 3.3 2.5
  Dyspnea 7.4 9.2 9.8
  Infection Upper Respiratory 1.1 2.6 3.3
  Tracheobronchitis 0.7 0.7 3.3
SPECIAL SENSES
  Disturbance Vision 0.7 2.6 0.8

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 events leading to discontinuation of BETAPACE AF (sotalol hcl) were: fatigue 4.6%, bradycardia 2.4%, proarrhythmia 2.2%, dyspnea 2%, and QT interval prolongation 1.4%.

In clinical trials involving 1292 patients with sustained VT/VF, the common adverse events (occurring in ≥ 2% of patients) were similar to those described for the AFIB/AFL population.

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.

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, Torsades de Pointe, 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 also include rare reports of: emotional liability, 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 AF (sotalol hcl) during investigational use and foreign marketing experience.

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

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Betapace AF - User Reviews

Betapace AF 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 AF 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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