Betapace 120mg Tablets
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).
Drug Class
Antiarrhythmic
Pharmacologic Class
Beta-adrenergic Blocker (non-selective), Potassium Channel Blocker (Class II and Class III Antiarrhythmic)
Pregnancy Category
Category C
FDA Approved
Oct 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sotalol is a medication used to treat certain types of irregular heartbeats (arrhythmias). It works by slowing down your heart rate and helping your heart beat more regularly. It's important to take this medication exactly as prescribed, usually on an empty stomach, and not to stop it suddenly.
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 maintain your treatment schedule to ensure the medication works effectively.
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.
When measuring liquid doses, use the measuring device provided with the medication or ask your pharmacist for a suitable device. Avoid using household teaspoons or tablespoons, as this may lead to inaccurate dosing and potentially harmful side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. If you have a liquid (suspension) formulation, 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 schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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 maintain your treatment schedule to ensure the medication works effectively.
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.
When measuring liquid doses, use the measuring device provided with the medication or ask your pharmacist for a suitable device. Avoid using household teaspoons or tablespoons, as this may lead to inaccurate dosing and potentially harmful side effects.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. If you have a liquid (suspension) formulation, 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 schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take sotalol on an empty stomach, at least 1 hour before or 2 hours after a meal. Avoid taking it with milk or dairy products.
- Do not stop taking sotalol suddenly, as this can worsen your heart condition. Your doctor will guide you on how to safely reduce the dose if needed.
- Avoid activities that require alertness until you know how sotalol affects you, as it can cause dizziness or lightheadedness.
- Report any new medications, including over-the-counter drugs, supplements, or herbal products, to your doctor or pharmacist, as many can interact with sotalol.
- Maintain adequate hydration and electrolyte balance, especially if you are also taking diuretics or have conditions that cause fluid loss (e.g., vomiting, diarrhea).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For ventricular arrhythmias: Initial 80 mg twice daily. For atrial fibrillation/flutter: Initial 80 mg once daily, then 80 mg twice daily.
Dose Range:
80 - 320 mg
Condition-Specific Dosing:
ventricularArrhythmias:
Initial 80 mg twice daily. May be increased to 160 mg twice daily if needed. Max 320 mg twice daily for life-threatening arrhythmias.
atrialFibrillationFlutter:
Initial 80 mg once daily (Betapace AF formulation). If tolerated and QTc < 500 ms, increase to 80 mg twice daily. Max 160 mg twice daily. Must be initiated in a hospital setting with continuous ECG monitoring for at least 3 days or 5 doses, whichever is longer.
conversionFromOtherAntiarrhythmics:
Discontinue previous antiarrhythmic therapy for at least 2-3 plasma half-lives before initiating sotalol.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Limited data; dosing is individualized based on body surface area or weight, typically 30 mg/m2 three times daily, adjusted based on response and QTc. Max 60 mg/m2 three times daily.
Adolescent:
Dosing similar to adults, but individualized based on weight and renal function.
Dose Adjustments
Renal Impairment:
Mild:
CrCl > 60 mL/min: No adjustment needed.
Moderate:
CrCl 40-60 mL/min: Administer 50% of the usual dose or extend dosing interval to 24 hours.
Severe:
CrCl 20-39 mL/min: Administer 25% of the usual dose or extend dosing interval to 36-48 hours.
Dialysis:
CrCl < 20 mL/min: Generally contraindicated due to significant accumulation and increased risk of proarrhythmia. Sotalol is dialyzable, but dosing post-dialysis is complex and not routinely recommended for chronic use.
Hepatic Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed. Sotalol is minimally metabolized by the liver.
Pharmacology
Mechanism of Action
Sotalol is a non-selective beta-adrenergic receptor blocker (Class II antiarrhythmic) and a potassium channel blocker (Class III antiarrhythmic). It prolongs the cardiac action potential duration and refractoriness in all cardiac tissues by blocking the delayed rectifier potassium current (IKr). This dual action contributes to its antiarrhythmic effects by reducing automaticity, slowing AV nodal conduction, and prolonging the effective refractory period.
Pharmacokinetics
Absorption:
Bioavailability:
90-100%
Tmax:
2.5-4 hours
FoodEffect:
Food, especially milk and dairy products, can reduce the bioavailability by approximately 20-30%. Should be taken on an empty stomach (1 hour before or 2 hours after meals).
Distribution:
Vd:
1.2-2.4 L/kg
ProteinBinding:
<1%
CnssPenetration:
Limited
Elimination:
HalfLife:
10-20 hours (prolonged in renal impairment)
Clearance:
Renal clearance is approximately 120 mL/min/1.73m2
ExcretionRoute:
Renal (urine)
Unchanged:
80-90%
Pharmacodynamics
OnsetOfAction:
Within 1-2 hours
PeakEffect:
2.5-4 hours
DurationOfAction:
12-24 hours
Safety & Warnings
BLACK BOX WARNING
To minimize the risk of drug-induced ventricular tachycardia (Torsade de Pointes), patients initiated on Betapace AF (sotalol hydrochloride) or reinitiated on Betapace AF must be placed for a minimum of 3 days in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring and have staff skilled in the identification and treatment of arrhythmias. Patients should not be discharged until their QTc interval is stable and acceptable. For patients with a creatinine clearance of 40-60 mL/min, the initial dose and dose increments should be halved and the dosing interval extended. For patients with a creatinine clearance of < 40 mL/min, Betapace AF is contraindicated.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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 getting or maintaining an erection
Heart failure, which can occur even if you have no prior history of heart disease; if you have pre-existing heart disease, inform your doctor, and seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ New or worsening swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor or seek medical help:
Dizziness, fatigue, or weakness
Headache
* Diarrhea, stomach upset, or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Although rare, some people may experience severe and potentially life-threatening side effects while 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 getting or maintaining an erection
Heart failure, which can occur even if you have no prior history of heart disease; if you have pre-existing heart disease, inform your doctor, and seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden weight gain
+ Abnormal heartbeat
+ New or worsening swelling in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor or seek medical help:
Dizziness, fatigue, or weakness
Headache
* Diarrhea, stomach upset, or vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting (syncope)
- Very slow heart rate (bradycardia)
- New or worsening palpitations or irregular heartbeats
- Shortness of breath, especially with exertion or lying down
- Swelling in your ankles or feet
- Unusual fatigue or weakness
- Chest pain
- Signs of low blood sugar if you are diabetic (though sotalol can mask some symptoms)
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
Use of medications for abnormal heart rhythms
* Use of medications that can cause 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.
To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to verify that it is safe for you 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.
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
Use of medications for abnormal heart rhythms
* Use of medications that can cause 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.
To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to verify that it is safe for you 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.
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
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor. Discuss any concerns or questions with your doctor.
Electrocardiogram (ECG) Monitoring
You will need to undergo an ECG before starting this medication and during treatment. Consult with your doctor about this requirement.
Impact on Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Low Blood Sugar Risk
This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This risk is higher in people with diabetes, children, and those who are fasting, undergoing surgery, or experiencing vomiting. If you have questions or concerns, discuss them with your doctor.
Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels.
Fluid Loss and Blood Sugar Control
Notify your doctor if you experience fluid loss, unusual sweating, vomiting, diarrhea, decreased appetite, or excessive thirst.
Discontinuing the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, especially in people with certain types of heart disease. To avoid side effects, your doctor will guide 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 rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor about this risk.
Allergic Reactions
If you have a history of severe allergic reactions, discuss this with your doctor, as you may be at risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as epinephrine may be less effective while taking this medication.
Gender-Specific Risk
Female patients may be at 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.
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
Until you know how this medication affects you, avoid driving and other activities that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor. Discuss any concerns or questions with your doctor.
Electrocardiogram (ECG) Monitoring
You will need to undergo an ECG before starting this medication and during treatment. Consult with your doctor about this requirement.
Impact on Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Low Blood Sugar Risk
This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. This risk is higher in people with diabetes, children, and those who are fasting, undergoing surgery, or experiencing vomiting. If you have questions or concerns, discuss them with your doctor.
Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels.
Fluid Loss and Blood Sugar Control
Notify your doctor if you experience fluid loss, unusual sweating, vomiting, diarrhea, decreased appetite, or excessive thirst.
Discontinuing the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, especially in people with certain types of heart disease. To avoid side effects, your doctor will guide 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 rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor about this risk.
Allergic Reactions
If you have a history of severe allergic reactions, discuss this with your doctor, as you may be at risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as epinephrine may be less effective while taking this medication.
Gender-Specific Risk
Female patients may be at 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.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Hypotension (low blood pressure)
- Bronchospasm (difficulty breathing)
- Hypoglycemia (low blood sugar)
- Congestive heart failure
- Cardiogenic shock
- Torsade de Pointes (a dangerous type of irregular heartbeat)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may include atropine for bradycardia, isoproterenol or dobutamine for hypotension/heart failure, glucagon, intravenous fluids, and temporary pacing. For Torsade de Pointes, IV magnesium sulfate, overdrive pacing, or cardioversion may be necessary. Sotalol is dialyzable.
Drug Interactions
Contraindicated Interactions
- Class Ia antiarrhythmics (e.g., disopyramide, quinidine, procainamide)
- Class III antiarrhythmics (e.g., amiodarone, dronedarone)
- Other drugs that prolong the QT interval (e.g., phenothiazines, tricyclic antidepressants, macrolide antibiotics like erythromycin, fluoroquinolones like moxifloxacin, cisapride, bepridil)
- Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B IV) due to increased risk of Torsade de Pointes.
Major Interactions
- Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and hypotension.
- Other beta-blockers: Additive beta-blocking effects, leading to severe bradycardia, hypotension, or heart failure.
- Digoxin: Increased risk of bradycardia and AV block. Sotalol may mask signs of digoxin toxicity.
- Insulin and oral hypoglycemics: Sotalol may mask symptoms of hypoglycemia (e.g., tachycardia, palpitations) and prolong hypoglycemic episodes.
- Clonidine: May potentiate rebound hypertension upon clonidine withdrawal.
- Neuromuscular blocking agents (e.g., tubocurarine): Prolongation of neuromuscular blockade.
Moderate Interactions
- Antacids containing aluminum or magnesium: May reduce sotalol absorption if taken concurrently. Separate administration by at least 2 hours.
- Reserpine, guanethidine: Potentiation of hypotensive and bradycardic effects.
- Non-steroidal anti-inflammatory drugs (NSAIDs): May reduce the hypotensive effect of sotalol.
- Cimetidine: May increase sotalol plasma concentrations due to reduced renal clearance.
Minor Interactions
- Alcohol: May enhance hypotensive effects.
Monitoring
Baseline Monitoring
Electrocardiogram (ECG)
Rationale: To assess baseline heart rate, rhythm, PR, QRS, and especially QTc interval. QTc must be < 450 ms (or < 500 ms in patients with intraventricular conduction delay) before initiation.
Timing: Prior to first dose
Serum Electrolytes (Potassium, Magnesium)
Rationale: Hypokalemia and hypomagnesemia increase the risk of Torsade de Pointes. Must be corrected prior to initiation.
Timing: Prior to first dose
Renal Function (Creatinine Clearance)
Rationale: Sotalol is primarily renally eliminated; dose adjustment is required for impaired renal function.
Timing: Prior to first dose
Blood Pressure and Heart Rate
Rationale: To establish baseline and monitor for excessive bradycardia or hypotension.
Timing: Prior to first dose
Routine Monitoring
Electrocardiogram (ECG) with QTc interval
Frequency: Daily during initiation/dose escalation (in-hospital), then periodically (e.g., every 3-6 months or as clinically indicated) for chronic therapy.
Target: QTc < 500 ms (ideally < 480 ms)
Action Threshold: Discontinue or reduce dose if QTc prolongs to > 500 ms (or > 520 ms if QRS is wide) or if Torsade de Pointes occurs.
Serum Electrolytes (Potassium, Magnesium)
Frequency: Periodically, especially if patient is on diuretics or has conditions predisposing to electrolyte imbalance.
Target: Potassium > 4.0 mEq/L, Magnesium > 2.0 mEq/L
Action Threshold: Correct imbalances promptly.
Renal Function (Creatinine Clearance)
Frequency: Periodically (e.g., every 6-12 months or more frequently in elderly or those with worsening renal function).
Target: Maintain appropriate CrCl for dose
Action Threshold: Adjust dose if CrCl declines.
Blood Pressure and Heart Rate
Frequency: Regularly during therapy.
Target: Systolic BP > 90 mmHg, Heart Rate > 50 bpm (unless otherwise clinically indicated)
Action Threshold: Reduce dose or discontinue if symptomatic bradycardia or hypotension occurs.
Symptom Monitoring
- Dizziness
- Lightheadedness
- Syncope (fainting)
- Palpitations (new or worsening)
- Shortness of breath
- Fatigue
- Chest pain
- Swelling in ankles/feet (signs of heart failure)
- Cold hands/feet
- Depression
- Sleep disturbances
Special Patient Groups
Pregnancy
Category C. Sotalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placenta.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless clearly necessary.
Second Trimester:
Potential for fetal bradycardia, hypoglycemia, and growth restriction.
Third Trimester:
Increased risk of fetal/neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate for signs of beta-blockade.
Lactation
Sotalol is excreted into breast milk in significant amounts. The American Academy of Pediatrics considers sotalol to be compatible with breastfeeding, but caution is advised. Monitor the infant for signs of beta-blockade (e.g., bradycardia, cyanosis, hypoglycemia).
Infant Risk:
Moderate risk (L3). Potential for bradycardia, hypoglycemia, and other beta-blocker effects in the infant. Consider alternative agents or monitor infant closely.
Pediatric Use
Use in pediatric patients is generally limited to life-threatening arrhythmias due to lack of extensive safety and efficacy data. Dosing is complex and individualized based on body surface area or weight, with careful monitoring of heart rate, blood pressure, and QTc interval. Renal function must be assessed.
Geriatric Use
Elderly patients are at increased risk of adverse effects, particularly bradycardia, hypotension, and proarrhythmia (Torsade de Pointes), due to age-related decline in renal function and potential for multiple comorbidities and polypharmacy. Renal function should be carefully assessed and dose adjusted accordingly. Initiate at lower doses and titrate slowly with close monitoring.
Clinical Information
Clinical Pearls
- Sotalol has both Class II (beta-blocker) and Class III (potassium channel blocker) antiarrhythmic properties.
- Initiation and dose escalation of sotalol for atrial fibrillation/flutter (Betapace AF) must occur in a hospital setting with continuous ECG monitoring due to the significant risk of Torsade de Pointes.
- Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize the risk of proarrhythmia.
- Take sotalol on an empty stomach (1 hour before or 2 hours after meals) to optimize absorption.
- Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, as it can exacerbate angina or precipitate myocardial infarction.
- Monitor QTc interval closely; discontinue or reduce dose if QTc prolongs significantly (>500 ms).
- Renal function is critical for sotalol dosing; dose adjustments are mandatory for impaired renal function.
- Sotalol can mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism.
Alternative Therapies
- Other Class III antiarrhythmics (e.g., amiodarone, dronedarone, dofetilide)
- Other beta-blockers (e.g., metoprolol, carvedilol, atenolol) for rate control or other indications
- Calcium channel blockers (e.g., diltiazem, verapamil) for rate control
- Digoxin for rate control
- Catheter ablation for atrial fibrillation or ventricular arrhythmias
- Implantable cardioverter-defibrillator (ICD) for prevention of sudden cardiac death in high-risk patients with ventricular arrhythmias
Cost & Coverage
Average Cost:
Varies widely by strength and quantity (e.g., $10-$100+) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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.