Sotalol AF 80mg Tablets

Manufacturer EPIC 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
Class III Antiarrhythmic; Non-selective Beta-Adrenergic Blocker
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Pregnancy Category
Category C
FDA Approved
Oct 2000
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sotalol AF is a medication used to help keep your heart beating in a regular rhythm, specifically for a condition called atrial fibrillation or flutter. It works by slowing down your heart rate and helping to correct irregular heartbeats. 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're feeling well. However, there are some important precautions to keep in mind. Do not take antacids that contain aluminum or magnesium within 2 hours of taking this medication.

Special Instructions for Liquid (Suspension) Formulation

If you have trouble 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 carefully using the measuring device provided with the medication. If you don't have a measuring device, ask your pharmacist for one. Never use a household teaspoon or tablespoon to measure your medication, as this can 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 you have a liquid (suspension) formulation, store it at room temperature. If you don't use the entire liquid formulation within 3 months, discard any remaining amount.

What to Do If You Miss a Dose

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

  • Take Sotalol AF on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Do not stop taking Sotalol AF suddenly, as this can worsen your heart condition. Your doctor will tell you how to slowly reduce the dose if needed.
  • Avoid grapefruit juice, as it may affect how the medication works.
  • Limit alcohol intake, as it can affect heart rhythm and blood pressure.
  • Maintain a healthy diet and exercise routine as advised by your doctor.
  • Report any new medications, supplements, or over-the-counter drugs to your doctor or pharmacist, as many can interact with Sotalol AF.
  • Carry a medical alert card or wear a bracelet indicating you are taking Sotalol AF.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 80 mg once daily. After 3 days, if QTc <500 ms, increase to 80 mg twice daily. May increase to 120 mg twice daily, then 160 mg twice daily, with 3-day intervals between increases, if QTc <500 ms and adequate renal function. Max: 160 mg twice daily.
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

Atrial Fibrillation/Flutter: Initial 80 mg once daily, then 80 mg twice daily, up to 160 mg twice daily based on QTc and renal function. Dosing interval adjusted based on CrCl.
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Pediatric Dosing

Neonatal: Not established for atrial fibrillation/flutter.
Infant: Not established for atrial fibrillation/flutter.
Child: Not established for atrial fibrillation/flutter.
Adolescent: Not established for atrial fibrillation/flutter.
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Dose Adjustments

Renal Impairment:

Mild: CrCl >60 mL/min: 80 mg twice daily. CrCl 40-60 mL/min: 80 mg once daily.
Moderate: CrCl 40-60 mL/min: 80 mg once daily.
Severe: CrCl <40 mL/min: Contraindicated due to increased risk of proarrhythmia.
Dialysis: Contraindicated. Sotalol is dialyzable, but accumulation in severe renal impairment makes it unsuitable.

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 (Class II antiarrhythmic activity) and a Class III antiarrhythmic agent. It prolongs the cardiac action potential duration and refractoriness in all cardiac tissues by blocking potassium channels involved in repolarization (primarily IKr). This combination of beta-blockade and potassium channel blockade contributes to its antiarrhythmic effects.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 2.5-4 hours
FoodEffect: Food (especially high-fat meals) can reduce the rate and extent of absorption by approximately 20-30%. Should be taken on an empty stomach.

Distribution:

Vd: 1.2-2.4 L/kg
ProteinBinding: <10%
CnssPenetration: Limited

Elimination:

HalfLife: 10-20 hours (prolonged in renal impairment)
Clearance: Renal clearance is approximately 120 mL/min/1.73 m²
ExcretionRoute: Renal (primarily unchanged)
Unchanged: >80%
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Pharmacodynamics

OnsetOfAction: Within 2-3 hours (antiarrhythmic effect)
PeakEffect: 2.5-4 hours
DurationOfAction: 12-24 hours (dose-dependent)

Safety & Warnings

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BLACK BOX WARNING

Sotalol AF can cause life-threatening proarrhythmia, including Torsade de Pointes (TdP). The risk of TdP is dose-related and increases with QT interval prolongation, female gender, and history of sustained ventricular tachycardia/fibrillation. Sotalol AF must be initiated in a hospital setting with continuous ECG monitoring and availability of resuscitation equipment. Patients must be monitored for a minimum of 3 days (or 6 doses) on the maintenance dose. Dosing must be individualized based on creatinine clearance and QTc interval. Sotalol AF is contraindicated in patients with a baseline QTc >450 ms (or >500 ms in patients with intraventricular conduction delay), uncorrected hypokalemia or hypomagnesemia, sinus bradycardia (<50 bpm), sick sinus syndrome, second- or third-degree AV block (unless paced), congenital or acquired long QT syndromes, cardiogenic shock, uncontrolled heart failure, or bronchial asthma/COPD.
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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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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 has been reported in people taking this medication. If you have a history of heart disease, inform your doctor. 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 side effects or only minor ones, it's 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 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness, especially when standing up
  • Fainting or passing out (syncope)
  • Very slow heart rate (less than 50 beats per minute)
  • New or worsening shortness of breath
  • Swelling in your ankles, feet, or legs
  • Unusual weight gain
  • Chest pain
  • New or worsening irregular heartbeats (palpitations)
  • Muscle weakness or cramps (could indicate low potassium or magnesium)
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Asthma or other respiratory problems that cause shortness of breath or wheezing
+ Heart failure (a weak heart)
+ Abnormal heart rhythms, including heart block or sick sinus syndrome
+ A slow heartbeat
Low levels of potassium or magnesium in your blood
If you are taking medications for an irregular 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, if you are breast-feeding, please note that you should not breast-feed while taking this medication.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems, including any medical conditions or allergies

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so. This will help prevent potential interactions between this medication and other substances you are taking.
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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 down 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.

Electrocardiogram (ECG) Monitoring
You will need to undergo an ECG before starting this medication and during treatment. Consult with your doctor to discuss the details.

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 individuals 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 while taking this medication. Inform your doctor if you experience fluid loss, excessive sweating, vomiting, diarrhea, decreased appetite, or unusual thirst.

Stopping the Medication
Do not stop taking this medication abruptly, as this can lead to worsened chest pain or even heart attack, particularly in individuals with certain types of heart disease. To avoid side effects, your doctor will guide you on how to gradually stop the 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 to discuss the risks.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. You may be at a higher 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 be at a higher risk of side effects. Discuss this with your doctor to understand the potential risks.

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

Overdose Symptoms:

  • Bradycardia (severe slowing of heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm (difficulty breathing)
  • Hypoglycemia (low blood sugar)
  • Hypokalemia (low potassium)
  • Torsade de Pointes (a specific type of dangerous irregular heartbeat)
  • Cardiogenic shock
  • Asystole (cardiac arrest)

What to Do:

Seek immediate medical attention or call 911. For suspected overdose, call Poison Control at 1-800-222-1222. Treatment is supportive and may include atropine for bradycardia, intravenous fluids and vasopressors for hypotension, isoproterenol or transvenous pacing for TdP, and glucagon for severe beta-blockade effects. Hemodialysis can remove sotalol from the body.

Drug Interactions

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Contraindicated Interactions

  • QT-prolonging drugs (e.g., Class IA and Class III antiarrhythmics, phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolone antibiotics, cisapride, bepridil, halofantrine, pimozide)
  • Drugs that cause hypokalemia or hypomagnesemia (e.g., diuretics, laxatives, amphotericin B IV) unless electrolyte imbalance is corrected
  • Other beta-blockers (additive effects)
  • Calcium channel blockers (e.g., verapamil, diltiazem) that depress myocardial contractility or AV conduction
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Major Interactions

  • Digoxin (increased risk of bradycardia, AV block)
  • Insulin and oral hypoglycemics (mask symptoms of hypoglycemia, potentiate hypoglycemic effect)
  • Clonidine (exacerbation of rebound hypertension upon withdrawal of clonidine)
  • Reserpine, guanethidine (additive hypotensive and bradycardic effects)
  • Neuromuscular blockers (prolongation of neuromuscular blockade)
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Moderate Interactions

  • Antacids containing aluminum or magnesium (decreased sotalol absorption if taken concurrently)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (may blunt antihypertensive effect)
  • Cimetidine (may increase sotalol bioavailability)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline QTc interval and identify pre-existing conduction abnormalities. QTc must be <450 ms (or <500 ms in patients with intraventricular conduction delay) before initiation.

Timing: Prior to first dose and after 2-3 days on initial dose, and after each dose increment.

Serum Potassium (K+)

Rationale: Hypokalemia increases the risk of Torsade de Pointes. Must be corrected to >4.0 mEq/L.

Timing: Prior to first dose.

Serum Magnesium (Mg2+)

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

Timing: Prior to first dose.

Renal Function (CrCl)

Rationale: Sotalol is primarily renally eliminated; dose adjustment is required for impaired renal function.

Timing: Prior to first dose.

Heart Rate and Blood Pressure

Rationale: To assess baseline cardiovascular status and identify contraindications (e.g., sinus bradycardia, hypotension).

Timing: Prior to first dose.

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Routine Monitoring

Electrocardiogram (ECG) with QTc measurement

Frequency: After 2-3 days on initial dose, after each dose increment, and periodically thereafter (e.g., every 3-6 months or as clinically indicated).

Target: QTc <500 ms (absolute limit for continuation)

Action Threshold: If QTc ≥500 ms, reduce dose or discontinue. If QTc ≥520 ms, discontinue immediately.

Serum Potassium (K+)

Frequency: Periodically, especially if on diuretics or other drugs affecting electrolytes.

Target: >4.0 mEq/L

Action Threshold: Correct hypokalemia immediately.

Serum Magnesium (Mg2+)

Frequency: Periodically, especially if on diuretics or other drugs affecting electrolytes.

Target: Normal range

Action Threshold: Correct hypomagnesemia immediately.

Renal Function (CrCl)

Frequency: Periodically, especially in elderly or those with risk factors for renal decline.

Target: Not applicable

Action Threshold: Adjust dose or discontinue if CrCl falls below 40 mL/min.

Heart Rate

Frequency: Daily during initiation, then periodically.

Target: >50 bpm (unless clinically indicated for lower rates)

Action Threshold: If symptomatic bradycardia (<50 bpm), reduce dose or discontinue.

Blood Pressure

Frequency: Daily during initiation, then periodically.

Target: Within normal limits for patient

Action Threshold: If symptomatic hypotension, reduce dose or discontinue.

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Symptom Monitoring

  • Palpitations
  • Dizziness
  • Lightheadedness
  • Syncope
  • Shortness of breath
  • Chest pain
  • Fatigue
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Signs of heart failure exacerbation (e.g., edema, weight gain)

Special Patient Groups

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Pregnancy

Sotalol is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Sotalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm based on animal data; human data limited.
Second Trimester: Potential for fetal harm; monitor fetal heart rate and growth.
Third Trimester: Potential for fetal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate for these effects if exposed near term.
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Lactation

Sotalol is excreted into breast milk. The amount ingested by the infant is significant. 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 discontinue the drug, taking into account the importance of the drug to the mother. Lactation Risk Category L3 (Moderately Safe).

Infant Risk: Risk of 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 of Sotalol AF for atrial fibrillation/flutter have not been established in pediatric patients. Sotalol (Betapace) is approved for pediatric use for life-threatening ventricular arrhythmias, with dosing based on body surface area and careful monitoring.

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Geriatric Use

Elderly patients are more likely to have decreased renal function, which can lead to increased sotalol levels and an increased risk of proarrhythmia. Dose adjustments based on creatinine clearance are crucial. Initiate at lower doses and titrate slowly with careful monitoring.

Clinical Information

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Clinical Pearls

  • Sotalol AF initiation requires hospitalization for at least 3 days with continuous ECG monitoring due to the risk of Torsade de Pointes.
  • Always check baseline QTc, potassium, and magnesium levels before starting and during therapy. Correct any electrolyte imbalances.
  • Dose adjustments are critical for renal impairment; Sotalol AF is contraindicated if CrCl <40 mL/min.
  • Instruct patients to take Sotalol AF on an empty stomach to ensure consistent absorption.
  • Never abruptly discontinue sotalol due to the risk of exacerbating arrhythmias or angina.
  • Be vigilant for signs of proarrhythmia (e.g., new palpitations, dizziness, syncope) and bradycardia.
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Alternative Therapies

  • Other Class III antiarrhythmics (e.g., amiodarone, dronedarone, dofetilide)
  • Other beta-blockers (e.g., metoprolol, carvedilol) for rate control
  • Calcium channel blockers (e.g., diltiazem, verapamil) for rate control
  • Digoxin for rate control
  • Catheter ablation
  • Electrical cardioversion
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic 80mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.