Betapace AF 80mg Tablets

Manufacturer COVIS PHARMA Active Ingredient Sotalol Tablets(SOE ta lole) Pronunciation SOE ta lole
WARNING: This drug may cause a life-threatening type of heartbeat that is not normal (prolonged QT interval). Talk with your doctor if you have a long QT on ECG.You will have to start and restart this drug in a setting where your heart will be watched nonstop. Talk with your doctor.If you have kidney disease, talk to your doctor. @ COMMON USES: It is used to treat certain types of life-threatening abnormal heartbeats.It is used to keep a normal heartbeat in people who have a certain type of abnormal heartbeat (atrial fibrillation or atrial flutter).
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Drug Class
Antiarrhythmic
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Pharmacologic Class
Beta-adrenergic blocker (non-selective), Potassium channel blocker (Class III antiarrhythmic)
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Pregnancy Category
Category B
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FDA Approved
Oct 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sotalol is a medication used to help keep your heart beating in a regular rhythm, especially if you have a condition called atrial fibrillation or atrial flutter. It works by slowing down certain electrical signals in your heart. Because it can affect your heart's electrical activity, it's very important to take it exactly as prescribed and to have your heart monitored closely, especially when you first start taking it.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, and it's best to take it at the same time every day.

Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better. It's essential to take your medication as prescribed to ensure its effectiveness.

Important Interactions to Avoid

Do not take antacids containing aluminum or magnesium within 2 hours of taking this medication, as they may interfere with its absorption.

Special Instructions for Liquid (Suspension) Formulation

If you have difficulty swallowing pills, your doctor or pharmacist can help you prepare a liquid (suspension) formulation. If a liquid formulation is prepared, make sure to shake it well before use.

To ensure accurate dosing, measure the liquid medication carefully using the measuring device provided with the medication. If no device is provided, ask your pharmacist for a suitable measuring device. Do not use a household teaspoon or tablespoon to measure your medication, as this may lead to an incorrect dose.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. If a liquid (suspension) formulation is prepared, store it at room temperature and discard any unused portion after 3 months.

What to Do If You Miss a Dose

If you miss a dose, skip it and return to your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed dose.
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Lifestyle & Tips

  • Avoid sudden discontinuation of the medication; it should be tapered off under medical supervision.
  • Report any symptoms of dizziness, lightheadedness, or fainting immediately.
  • Avoid activities requiring mental alertness until you know how the medication affects you.
  • Maintain adequate hydration and electrolyte balance, especially if experiencing vomiting or diarrhea.
  • Limit alcohol intake as it may enhance hypotensive effects.
  • Inform all healthcare providers, including dentists, that you are taking sotalol.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 80 mg orally once daily. May be increased to 80 mg twice daily after 3 days, then to 120 mg twice daily if needed. Max: 160 mg twice daily.
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

atrialFibrillationFlutter: Initial: 80 mg orally once daily. Dose may be increased to 80 mg twice daily after 3 days, then to 120 mg twice daily if needed. Maximum recommended dose is 160 mg twice daily. Doses must be individualized based on QTc interval and renal function. Initiation and reinitiation of therapy must occur in a hospital setting with continuous ECG monitoring for at least 3 days.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: CrCl >60 mL/min: No adjustment. CrCl 40-60 mL/min: Initial 80 mg once daily, then 80 mg twice daily if needed. CrCl 30-39 mL/min: Initial 80 mg once daily.
Moderate: CrCl 40-60 mL/min: Initial 80 mg once daily, then 80 mg twice daily if needed. CrCl 30-39 mL/min: Initial 80 mg once daily.
Severe: CrCl <30 mL/min: Contraindicated for Betapace AF.
Dialysis: Sotalol is dialyzable. Contraindicated in patients with CrCl <30 mL/min for Betapace AF. For Betapace (ventricular arrhythmias), dose reduction or extended dosing interval is required, and administration after dialysis may be considered.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.

Pharmacology

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Mechanism of Action

Sotalol is a non-selective beta-adrenergic receptor blocker that also possesses Class III antiarrhythmic properties. It prolongs the cardiac action potential duration and refractoriness in all cardiac tissues by blocking potassium channels (primarily IKr, the rapid component of the delayed rectifier potassium current). This effect is dose-dependent and contributes to its antiarrhythmic action.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 2.5-4 hours
FoodEffect: Food (especially high-fat meals) can decrease Cmax and AUC by approximately 20-30%, but this is generally not considered clinically significant for dosing.

Distribution:

Vd: 1.6-2.4 L/kg
ProteinBinding: <1%
CnssPenetration: Limited

Elimination:

HalfLife: 10-20 hours (prolonged in renal impairment)
Clearance: Approximately 130 mL/min/1.73 m^2 (renal clearance)
ExcretionRoute: Renal (primarily unchanged)
Unchanged: 80-90%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours (beta-blocking effects); antiarrhythmic effects may take longer to stabilize with titration.
PeakEffect: 2.5-4 hours (plasma concentration); full antiarrhythmic effect may be seen after several days of stable dosing.
DurationOfAction: 12-24 hours (due to half-life, allows for twice-daily dosing)
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

To minimize the risk of drug-induced ventricular arrhythmia (Torsade de Pointes), patients initiated or reinitiated on Betapace AF must be placed in a facility that can provide continuous electrocardiographic monitoring and where a physician is available who is experienced in the treatment of arrhythmias and in the initiation of antiarrhythmic therapy. Patients should be discharged only after their QTc interval remains stable on the maintenance dose for at least 3 days. For patients with a creatinine clearance of 40-60 mL/min, the dose of Betapace AF should be initiated at 80 mg once daily. For patients with a creatinine clearance of 30-39 mL/min, the dose of Betapace AF should be initiated at 80 mg once daily. Betapace AF is contraindicated in patients with a creatinine clearance of less than 30 mL/min.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Chest pain or pressure
Abnormal heartbeat, including a fast or slow heartbeat, or a new or worsening irregular heartbeat
Excessive sweating
Changes in vision
Difficulty achieving or maintaining an erection
Heart failure, including worsening of existing heart failure, which may cause symptoms such as:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ Swelling in the arms or legs (new or worsening)

If you have a history of heart disease, inform your doctor, and seek immediate medical attention if you experience any of these symptoms.

Other Possible Side Effects

As with any medication, you may experience side effects. While many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:

Dizziness, fatigue, or weakness
Headache
* Diarrhea, stomach upset, or vomiting

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting (syncope)
  • Very slow heart rate (bradycardia)
  • New or worsening shortness of breath
  • Swelling in the ankles or feet
  • Chest pain
  • Severe fatigue or weakness
  • Any new or worsening irregular heartbeats (palpitations)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Asthma or other lung or breathing problems that cause shortness of breath or wheezing
+ Heart failure (weak heart)
+ Abnormal heartbeats, including heart block or sick sinus syndrome
+ Slow heartbeat
Low levels of potassium or magnesium in your blood
If you are taking medications for an abnormal heartbeat
* If you are taking any medications that can cause a prolonged QT interval, a type of abnormal heartbeat. There are many medications that can cause this condition, so ask your doctor or pharmacist if you are unsure.

Additionally, inform your doctor if you are breast-feeding, as you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have blood work done as directed by your doctor, and discuss the results with them. An electrocardiogram (ECG) is required before starting this medication and during treatment; consult with your doctor about this.

Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Risk of Low Blood Sugar
This medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This risk is higher in individuals with diabetes, children, and those who are fasting, including people undergoing surgery, experiencing reduced appetite, or vomiting. If you have questions, consult with your doctor. If you have diabetes, closely monitor your blood sugar levels.

Managing Blood Sugar and Fluid Loss
If you experience fluid loss, unusual sweating, vomiting, diarrhea, decreased appetite, or excessive thirst, notify your doctor.

Stopping the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain and, in some cases, heart attack. The risk is greater if you have certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.

Overactive Thyroid
This medication may make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Discuss this with your doctor.

Allergic Reactions
If you have a history of severe allergic reactions, consult with your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as epinephrine may be less effective while taking this medication.

Gender-Specific Risks
Female patients may have a higher risk of side effects; discuss this with your doctor.

Pregnancy and Breastfeeding
If you are pregnant or plan to become pregnant, consult with your doctor to weigh the benefits and risks of taking this medication during pregnancy.
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Overdose Information

Overdose Symptoms:

  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm
  • Hypoglycemia
  • Torsade de Pointes
  • Ventricular tachycardia
  • Asystole
  • Cardiogenic shock

What to Do:

Call 911 or your local emergency number immediately. For non-emergencies, call Poison Control at 1-800-222-1222. Treatment is supportive and may include atropine for bradycardia, isoproterenol, intravenous fluids, vasopressors, glucagon, and temporary pacing. Torsade de Pointes may require magnesium sulfate, overdrive pacing, or cardioversion.

Drug Interactions

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Contraindicated Interactions

  • Drugs that prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics, phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolone antibiotics, cisapride, bepridil, pimozide)
  • Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B IV)
  • Calcium channel blockers (e.g., verapamil, diltiazem) due to additive negative inotropic and chronotropic effects
  • Other beta-blockers
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Major Interactions

  • Digoxin (increased risk of bradycardia, AV block)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, potentiation of hypoglycemia)
  • Clonidine (rebound hypertension upon withdrawal of clonidine)
  • Reserpine, guanethidine (additive hypotensive and bradycardic effects)
  • Neuromuscular blocking agents (prolongation of block)
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Moderate Interactions

  • Antacids containing aluminum or magnesium (decreased sotalol absorption)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (may reduce antihypertensive effect)
  • Cimetidine (increased sotalol bioavailability)
  • Rifampin (decreased sotalol exposure)
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Minor Interactions

  • Alcohol (may enhance hypotensive effect)

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG) with QTc interval measurement

Rationale: To establish baseline QTc and identify pre-existing prolonged QT, which is a contraindication. Essential for assessing proarrhythmic risk.

Timing: Prior to initiation of therapy

Serum Potassium (K+)

Rationale: Hypokalemia increases the risk of Torsade de Pointes. Must be corrected prior to initiation.

Timing: Prior to initiation of therapy

Serum Magnesium (Mg2+)

Rationale: Hypomagnesemia increases the risk of Torsade de Pointes. Must be corrected prior to initiation.

Timing: Prior to initiation of therapy

Renal function (Creatinine Clearance)

Rationale: Sotalol is primarily renally excreted; dose adjustment is required based on CrCl. Contraindicated if CrCl <30 mL/min for Betapace AF.

Timing: Prior to initiation of therapy

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Routine Monitoring

Electrocardiogram (ECG) with QTc interval measurement

Frequency: Daily during initiation/reinitiation (for at least 3 days in hospital), then periodically (e.g., every 3-6 months or as clinically indicated)

Target: <500 ms (absolute); <60 ms increase from baseline

Action Threshold: Discontinue if QTc >500 ms or if QTc increases by >60 ms from baseline. Re-evaluate if QTc >480 ms.

Heart Rate

Frequency: Daily during initiation/reinitiation, then periodically (e.g., at each visit)

Target: Typically >50 bpm

Action Threshold: Bradycardia (<50 bpm) or symptomatic bradycardia.

Blood Pressure

Frequency: Daily during initiation/reinitiation, then periodically (e.g., at each visit)

Target: Individualized

Action Threshold: Symptomatic hypotension.

Serum Potassium (K+)

Frequency: Periodically, especially if on diuretics or with GI illness

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L (correct immediately)

Serum Magnesium (Mg2+)

Frequency: Periodically, especially if on diuretics or with GI illness

Target: 1.7-2.2 mg/dL

Action Threshold: <1.7 mg/dL (correct immediately)

Renal function (Creatinine Clearance)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated, especially in elderly or with changes in renal status)

Target: Individualized

Action Threshold: Significant decline in CrCl requiring dose adjustment or discontinuation.

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Symptom Monitoring

  • Palpitations
  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Shortness of breath
  • Chest pain
  • Fatigue
  • Swelling in ankles/feet
  • Cold hands/feet
  • Wheezing or difficulty breathing

Special Patient Groups

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Pregnancy

Sotalol (Betapace AF) is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show no teratogenicity.
Second Trimester: Limited human data.
Third Trimester: May cause bradycardia, hypoglycemia, or respiratory depression in the neonate if used near term. Monitor neonate for these effects.
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Lactation

Sotalol is excreted into human breast milk. Due to the potential for serious adverse reactions in the breastfed infant (e.g., bradycardia, hypoglycemia), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: L3 (Moderate risk) - Potential for bradycardia, hypoglycemia, and other beta-blocker effects in the infant. Monitor infant for signs of beta-blockade.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for Betapace AF. Use of sotalol in pediatric patients for ventricular arrhythmias (Betapace) has been studied, but dosing and monitoring are complex and require specialized expertise.

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Geriatric Use

Elderly patients may be more susceptible to the adverse effects of sotalol, particularly bradycardia and proarrhythmia, due to age-related decline in renal function. Dose selection should be cautious, usually starting at the low end of the dosing range, and should be guided by renal function and careful monitoring of QTc interval.

Clinical Information

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Clinical Pearls

  • Sotalol has both beta-blocking (Class II) and potassium channel blocking (Class III) antiarrhythmic properties.
  • Initiation and reinitiation of Betapace AF must occur in a hospital setting with continuous ECG monitoring for at least 3 days due to the significant risk of Torsade de Pointes.
  • QTc interval must be carefully monitored before and during therapy; discontinue if QTc exceeds 500 ms.
  • Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize proarrhythmic risk.
  • Dose adjustments are critical in patients with renal impairment; Betapace AF is contraindicated if CrCl <30 mL/min.
  • Avoid concomitant use with other QT-prolonging drugs or drugs that cause electrolyte imbalances.
  • Patients should be instructed not to abruptly discontinue sotalol due to the risk of exacerbation of angina or arrhythmias.
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Alternative Therapies

  • Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
  • Other beta-blockers (e.g., metoprolol, carvedilol) for rate control or other indications, but without Class III properties
  • Calcium channel blockers (e.g., diltiazem, verapamil) for rate control
  • Catheter ablation for atrial fibrillation
  • Electrical cardioversion
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Cost & Coverage

Average Cost: $50 - $200 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.