Sotalol 240mg Tablets

Manufacturer APOTEX USA 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 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sotalol is a medication used to treat 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, as incorrect use can lead to serious side effects.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take this medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Avoid taking antacids that contain aluminum or magnesium within 2 hours of taking this medication.

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:

Shake the suspension well before using it.
Measure your liquid dose carefully using the measuring device provided with the medication. If you don't have one, ask your pharmacist for a device to measure your medication accurately.
Do not 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 a liquid (suspension) formulation is prepared, store it at room temperature.
Discard any unused portion of the liquid formulation after 3 months.

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 a missed dose.
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Lifestyle & Tips

  • Do not stop taking sotalol suddenly, as this can worsen your heart condition. Your doctor will tell you how to slowly reduce your dose if needed.
  • Take your pulse regularly as instructed by your doctor. Report if your pulse is too slow.
  • Avoid activities requiring alertness (e.g., driving, operating machinery) until you know how sotalol affects you, as it can cause dizziness or lightheadedness.
  • Avoid grapefruit juice, as it may affect how sotalol works.
  • Maintain adequate hydration and electrolyte balance, especially if you experience vomiting or diarrhea.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 80 mg orally twice daily. May be increased to 160 mg twice daily after 3 days. Further increases to 240 mg twice daily, then 320 mg twice daily may be considered if needed and tolerated, with 3 days between dose increments. Max dose for life-threatening ventricular arrhythmias: 480-640 mg/day in 2-3 divided doses. For AFib/flutter: Max 160 mg twice daily.
Dose Range: 80 - 640 mg

Condition-Specific Dosing:

ventricular_arrhythmias: Initial 80 mg BID, titrate up to 160-320 mg BID. Max 640 mg/day.
atrial_fibrillation_flutter: Initial 80 mg BID, titrate up to 160 mg BID. Max 320 mg/day (off-label for some patients, but generally 160 mg BID is max for AFib/flutter).
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Pediatric Dosing

Neonatal: Not established (limited data, use with extreme caution, individualized dosing based on body surface area or weight).
Infant: Not established (limited data, use with extreme caution, individualized dosing based on body surface area or weight).
Child: Initial 2 mg/kg/day orally in 3 divided doses. May be increased gradually to 5 mg/kg/day. Max 10 mg/kg/day or 640 mg/day, whichever is less. Dosing interval adjusted for renal function.
Adolescent: Similar to adult dosing, but consider weight and renal function. Initial 80 mg orally twice daily, titrate as per adult guidelines.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 60 mL/min: No adjustment. CrCl 40-60 mL/min: Dose interval every 24 hours (or 50% of normal dose).
Moderate: CrCl 20-39 mL/min: Dose interval every 36-48 hours (or 25% of normal dose).
Severe: CrCl < 20 mL/min: Not recommended or contraindicated due to high risk of proarrhythmia.
Dialysis: Sotalol is dialyzable. Administer dose after dialysis. Not recommended for patients on chronic dialysis due to significant accumulation and proarrhythmic risk.

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 potassium channel blocker (Class III antiarrhythmic activity). It prolongs the cardiac action potential duration and refractoriness in all cardiac tissues by blocking the delayed rectifier potassium current (IKr). It also reduces heart rate, myocardial contractility, and blood pressure due to its beta-blocking effects.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100%
Tmax: 2.5-4 hours
FoodEffect: Food (especially high-fat meals) can reduce absorption by approximately 20-30%.

Distribution:

Vd: 1.2-2.4 L/kg
ProteinBinding: Not significant (<1%)
CnssPenetration: Limited (low lipid solubility)

Elimination:

HalfLife: 10-20 hours (prolonged in renal impairment)
Clearance: Renal clearance is approximately 120 mL/min/1.73m^2
ExcretionRoute: Renal (unchanged drug)
Unchanged: 80-90%
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: 2.5-4 hours
DurationOfAction: 12-24 hours (dose-dependent)

Safety & Warnings

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BLACK BOX WARNING

To minimize the risk of drug-induced arrhythmia (Torsade de Pointes), patients initiated on sotalol or whose dose is increased must be hospitalized for a minimum of 3 days and be placed on continuous ECG monitoring. A 12-lead ECG should be performed 2-4 hours after each dose and prior to discharge to assess the QT interval. Sotalol is contraindicated in patients with a baseline QTc > 450 ms. Sotalol should not be used in patients with hypokalemia or hypomagnesemia prior to correction of these conditions.
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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
Erectile dysfunction

If you have a history of heart disease, inform your doctor. Be aware that this medication may cause or worsen heart failure. If you experience any of the following symptoms, contact your doctor immediately:

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. While 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 any other symptoms that bother you or do not go away, 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, contact 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)
  • Shortness of breath, especially with exertion or lying down
  • Swelling in your ankles or feet
  • New or worsening chest pain
  • New or worsening palpitations (feeling your heart skip a beat or beat irregularly)
  • Unusual fatigue or weakness
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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 and breathing 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.

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
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down 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 lab 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 a 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, discuss them with your doctor.

Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels.

Fluid Loss and Dehydration
Notify 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 a heart attack, especially if you have certain types of heart disease. To minimize 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. 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 an even 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 Risks
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.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Hypotension (very low blood pressure)
  • Bronchospasm (difficulty breathing, wheezing)
  • Hypoglycemia (low blood sugar)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Torsade de Pointes (a specific type of dangerous irregular heartbeat)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Class Ia antiarrhythmics (e.g., disopyramide, quinidine, procainamide)
  • Class III antiarrhythmics (e.g., amiodarone, dronedarone)
  • Other drugs that prolong QT interval (e.g., phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones, cisapride, terfenadine, astemizole, bepridil)
  • Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B IV) unless electrolyte imbalance is corrected
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Major Interactions

  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem) - risk of severe bradycardia, AV block, hypotension, heart failure
  • Digoxin - increased risk of bradycardia, AV block; sotalol can mask signs of digoxin toxicity
  • Other beta-blockers - additive beta-blocking effects (bradycardia, hypotension)
  • Insulin and oral hypoglycemics - sotalol can mask symptoms of hypoglycemia (tachycardia, palpitations) and prolong hypoglycemic episodes
  • Clonidine - risk of rebound hypertension upon clonidine withdrawal if sotalol is not tapered first
  • General anesthetics - enhanced myocardial depression and hypotension
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin) - increased risk of hypotension
  • NSAIDs - may reduce antihypertensive effect of sotalol
  • Cimetidine - may increase sotalol bioavailability (minor effect)
  • Aluminum and magnesium containing antacids - may reduce sotalol absorption (administer sotalol 2 hours before antacids)
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Minor Interactions

  • Not typically categorized as minor interactions with significant clinical impact.

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline QTc interval, heart rhythm, and identify pre-existing conduction abnormalities. QTc > 450 ms (or > 460 ms in females) is a contraindication.

Timing: Before initiation of therapy.

Serum Electrolytes (Potassium, Magnesium)

Rationale: Hypokalemia and hypomagnesemia increase the risk of Torsade de Pointes. Must be corrected before initiation.

Timing: Before initiation of therapy.

Renal Function (Creatinine Clearance)

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

Timing: Before initiation of therapy.

Heart Rate and Blood Pressure

Rationale: To establish baseline and monitor for bradycardia and hypotension.

Timing: Before initiation of therapy.

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Routine Monitoring

Electrocardiogram (ECG) - QTc interval

Frequency: Prior to each dose increase, 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 > 520 ms in patients with pre-existing wide QRS) or if QTc increases by > 60 ms from baseline. Consider dose reduction if QTc approaches 500 ms.

Serum Electrolytes (Potassium, Magnesium)

Frequency: Periodically, especially if patient is on diuretics or has GI losses.

Target: Potassium > 4.0 mEq/L, Magnesium > 2.0 mEq/L.

Action Threshold: Correct imbalances immediately.

Renal Function (Creatinine Clearance)

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

Target: Not applicable (used for dose adjustment).

Action Threshold: Adjust dose or discontinue if CrCl declines.

Heart Rate and Blood Pressure

Frequency: Regularly, especially during dose titration and with changes in clinical status.

Target: Heart rate > 50 bpm (unless otherwise clinically indicated), BP within target range.

Action Threshold: Bradycardia (< 50 bpm) or symptomatic hypotension may require dose reduction or discontinuation.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Syncope (fainting)
  • Palpitations (new or worsening)
  • Shortness of breath
  • Fatigue
  • Chest pain
  • Swelling of ankles/feet (signs of heart failure)
  • Cold extremities
  • Wheezing (bronchospasm)

Special Patient Groups

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Pregnancy

Category B. Animal studies have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefits outweigh potential risks. Sotalol crosses the placenta.

Trimester-Specific Risks:

First Trimester: Low risk based on animal data, but human data limited.
Second Trimester: Potential for fetal bradycardia, hypoglycemia, and growth restriction.
Third Trimester: Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression if used close to delivery.
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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 infant for bradycardia, hypotension, and hypoglycemia.

Infant Risk: L3 (Moderately safe) - Potential for infant bradycardia, hypoglycemia, and other beta-blocker effects. Monitor closely.
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Pediatric Use

Use with caution. Dosing is weight-based and requires careful titration and monitoring due to the risk of proarrhythmia and other adverse effects. Renal function must be carefully assessed.

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Geriatric Use

Increased risk of adverse effects, particularly bradycardia, hypotension, and proarrhythmia (Torsade de Pointes), due to age-related decline in renal function and increased sensitivity to drug effects. Initiate at lower doses and titrate slowly with careful monitoring of QTc and renal function.

Clinical Information

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Clinical Pearls

  • Sotalol requires hospitalization for initiation and dose escalation due to the significant risk of Torsade de Pointes (TdP).
  • Always correct hypokalemia and hypomagnesemia before initiating sotalol.
  • The QTc interval is the most critical monitoring parameter; discontinue if QTc exceeds 500 ms (or 520 ms with wide QRS) or increases by >60 ms from baseline.
  • Sotalol is primarily renally eliminated; significant dose adjustments are required for renal impairment. It is generally not recommended for severe renal impairment (CrCl < 20 mL/min).
  • Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, as it can exacerbate angina or precipitate myocardial infarction.
  • Food can reduce sotalol absorption; consistent administration relative to meals (e.g., always with food or always without) is recommended.
  • Sotalol has both Class II (beta-blocker) and Class III (potassium channel blocker) antiarrhythmic properties, making it unique among antiarrhythmics.
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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
  • Class Ic antiarrhythmics (e.g., flecainide, propafenone) for rhythm control in structurally normal hearts
  • Calcium channel blockers (e.g., verapamil, diltiazem) for rate control
  • Digoxin for rate control
  • Catheter ablation (non-pharmacological)
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (240mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (generic) or Tier 2 (preferred brand) on most formularies.
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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 this 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.