Sotalol 160mg 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
Non-selective Beta-adrenergic 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 it exactly as prescribed, as stopping it suddenly can be dangerous.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions closely.
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 directed by your doctor or healthcare provider, even if you start feeling well.
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 liquid 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 you have a liquid (suspension) formulation, store it at room temperature.
If you prepared a liquid formulation from tablets, discard any unused portion 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 the missed dose.
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Lifestyle & Tips

  • Take sotalol at the same time each day, preferably on an empty stomach (1 hour before or 2 hours after meals).
  • Do not stop taking sotalol suddenly without consulting your doctor, as this can worsen your heart condition.
  • Avoid antacids containing aluminum or magnesium within 2 hours of taking sotalol.
  • Monitor your pulse daily and report any significant slowing (e.g., below 50 beats per minute) to your doctor.
  • Be aware of symptoms of low blood sugar if you have diabetes, as sotalol can mask them.
  • Avoid activities requiring mental alertness until you know how sotalol affects you, as it can cause dizziness or lightheadedness.

Dosing & Administration

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Adult Dosing

Standard Dose: 80 mg orally twice daily
Dose Range: 80 - 320 mg

Condition-Specific Dosing:

ventricular_arrhythmias: Initial: 80 mg orally twice daily. May be increased to 160 mg twice daily after 3 days, then to 240 mg twice daily if needed. Max: 320 mg twice daily.
atrial_fibrillation_flutter: Initial: 80 mg orally twice daily. May be increased to 120 mg twice daily after 3 days, then to 160 mg twice daily if needed. Max: 160 mg twice daily for AF/AFL.
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Pediatric Dosing

Neonatal: Not established for routine use; specialized dosing for life-threatening arrhythmias, often 1-2 mg/kg/dose 3 times daily, titrated based on response and QTc.
Infant: Initial: 1-2 mg/kg/dose 3 times daily. Titrate based on response and QTc. Max: 4-8 mg/kg/day.
Child: Initial: 1-2 mg/kg/dose 3 times daily. Titrate based on response and QTc. Max: 4-8 mg/kg/day.
Adolescent: Initial: 1-2 mg/kg/dose 3 times daily. Titrate based on response and QTc. Max: 4-8 mg/kg/day or adult dose if weight > 60 kg.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 60 mL/min: No adjustment. CrCl 40-60 mL/min: Administer 50% of the dose or extend dosing interval to 24 hours.
Moderate: CrCl 20-39 mL/min: Administer 25% of the dose or extend dosing interval to 36-48 hours.
Severe: CrCl < 20 mL/min: Avoid use or administer 12.5% of the dose or extend dosing interval to 48-72 hours with extreme caution and close monitoring.
Dialysis: Sotalol is dialyzable. Administer dose after dialysis session. Avoid use if possible due to risk of proarrhythmia.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Sotalol is a non-selective beta-adrenergic receptor blocker (Class II antiarrhythmic activity) and also possesses Class III antiarrhythmic activity by prolonging the cardiac action potential duration and refractoriness in all cardiac tissues. This is achieved by blocking potassium channels responsible for repolarization, specifically the delayed rectifier potassium current (IKr).
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Pharmacokinetics

Absorption:

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

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/1.73m^2
ExcretionRoute: Renal (urine)
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 ventricular arrhythmia (Torsade de Pointes), patients initiated on sotalol or whose dose is increased must be placed in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring for a minimum of 3 days. Sotalol is contraindicated in patients with baseline QTc > 450 ms.
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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 can cause heart failure or worsen existing heart failure. Seek immediate medical attention if you experience:

Shortness of breath
Sudden weight gain
Abnormal heartbeat
Swelling in the arms or legs that is new or worsening

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 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 fainting (syncope)
  • Very slow heart rate (bradycardia)
  • Shortness of breath or difficulty breathing
  • Swelling in your ankles or feet
  • Unusual weight gain
  • New or worsening chest pain
  • New or worsening palpitations (feeling your heart race or skip beats)
  • Severe 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. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Asthma or other respiratory problems that cause shortness of breath or wheezing
+ Heart failure (a weakened 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 be sure to 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 complete medical history, including any health problems you have

Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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Precautions & Cautions

Important Warnings and Precautions

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 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 about this requirement.

Impact on Laboratory Tests
This medication may affect certain lab tests. Inform all your healthcare providers and laboratory 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 people with diabetes, children, and those who are fasting, including individuals undergoing surgery, experiencing abnormal eating habits, or vomiting. If you have 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. Notify your doctor if you experience fluid loss, excessive sweating, vomiting, diarrhea, decreased appetite, or unusual thirst.

Discontinuing 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 higher in individuals with certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually discontinue the medication. Seek immediate medical attention if you experience new or worsening chest pain or other heart problems.

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 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, 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:

  • Profound bradycardia (very slow heart rate)
  • Hypotension (very low blood pressure)
  • Bronchospasm (difficulty breathing)
  • 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 poison control, call 1-800-222-1222. Treatment may involve atropine for bradycardia, intravenous fluids and vasopressors for hypotension, glucagon, and potentially temporary pacing or magnesium for TdP.

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, halofantrine, pimozide)
  • Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem) due to additive negative chronotropic and inotropic effects
  • Other beta-blockers
  • Hypokalemia or hypomagnesemia (must be corrected before initiation)
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Major Interactions

  • Digoxin (increased risk of bradycardia, AV block)
  • Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, potential for prolonged hypoglycemia)
  • Clonidine (rebound hypertension upon withdrawal of clonidine)
  • Diuretics (increased risk of electrolyte disturbances, e.g., hypokalemia, hypomagnesemia, which can predispose to TdP)
  • Drugs that cause bradycardia (e.g., ivabradine, amiodarone, digoxin, clonidine)
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Moderate Interactions

  • Antacids containing aluminum or magnesium (decreased sotalol absorption)
  • Neuromuscular blockers (prolongation of block)
  • NSAIDs (may reduce antihypertensive effect)
  • Sympathomimetics (reduced beta-blocker effect)
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Minor Interactions

  • Alcohol (additive hypotensive effects)

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline heart rhythm, PR interval, QRS duration, and QTc interval. QTc must be <450 ms (or <500 ms in patients with bundle branch block) before initiation.

Timing: Prior to first dose

Serum Potassium (K+)

Rationale: Hypokalemia increases the risk of Torsade de Pointes (TdP). Must be corrected to >4 mEq/L.

Timing: Prior to first dose

Serum Magnesium (Mg2+)

Rationale: Hypomagnesemia increases the risk of TdP. Must be corrected.

Timing: Prior to first dose

Renal Function (CrCl)

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

Timing: Prior to first dose

Heart Rate (HR) and Blood Pressure (BP)

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

Timing: Prior to first dose

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Routine Monitoring

Electrocardiogram (ECG) with QTc measurement

Frequency: Before each dose increase, 2-3 days after reaching target dose, then periodically (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 increases by >60 ms from baseline, consider dose reduction.

Serum Potassium (K+) and Magnesium (Mg2+)

Frequency: Periodically, especially if on diuretics or experiencing vomiting/diarrhea.

Target: K+ > 4 mEq/L, Mg2+ within normal limits

Action Threshold: Correct abnormalities promptly.

Renal Function (CrCl)

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

Target: Not applicable

Action Threshold: Adjust dose if CrCl declines.

Heart Rate (HR) and Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and if symptoms of bradycardia or hypotension occur.

Target: HR > 50 bpm, BP within acceptable limits

Action Threshold: If HR < 50 bpm or symptomatic bradycardia/hypotension, reduce dose or discontinue.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Syncope (fainting)
  • Palpitations (new or worsening)
  • 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 Pregnancy Category B. Studies in animals have shown no evidence of teratogenicity, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show no teratogenicity. Risk appears low.
Second Trimester: Risk of fetal bradycardia and growth restriction, though not consistently reported.
Third Trimester: Risk of fetal/neonatal bradycardia, hypoglycemia, and respiratory depression due to beta-blockade. Monitor neonate for signs of beta-blockade.
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Lactation

Sotalol is excreted into 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 discontinue the drug, taking into account the importance of the drug to the mother.

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

Use in pediatric patients is limited to life-threatening arrhythmias and requires specialized expertise. Dosing is weight-based and requires careful titration with continuous ECG monitoring due to the risk of proarrhythmia and other adverse effects. Renal function must be carefully assessed.

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Geriatric Use

Elderly patients may be more sensitive to the effects of sotalol, particularly bradycardia and hypotension. Renal function often declines with age, necessitating dose adjustments based on creatinine clearance. Increased risk of Torsade de Pointes due to age-related changes in cardiac repolarization and polypharmacy.

Clinical Information

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Clinical Pearls

  • Sotalol initiation and dose escalation must occur in a hospital setting with continuous ECG monitoring for at least 3 days due to the risk of Torsade de Pointes (TdP).
  • Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize TdP risk.
  • QTc interval must be <450 ms (or <500 ms in patients with bundle branch block) before starting sotalol. Discontinue if QTc prolongs to >500 ms.
  • Sotalol is renally eliminated; significant dose adjustments are required for renal impairment. Avoid in severe renal failure.
  • Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, due to the risk of exacerbation of angina, myocardial infarction, or ventricular arrhythmias.
  • Food decreases sotalol absorption; administer 1 hour before or 2 hours after meals.
  • Monitor for signs of heart failure exacerbation, as sotalol has negative inotropic effects.
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Alternative Therapies

  • Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
  • Other beta-blockers (e.g., metoprolol, carvedilol, atenolol) for rate control or other indications, but without Class III effects
  • Class IC antiarrhythmics (e.g., flecainide, propafenone) for AF/AFL in patients without structural heart disease
  • Calcium channel blockers (e.g., diltiazem, verapamil) for rate control in AF/AFL
  • Digoxin for rate control in AF/AFL
  • Catheter ablation procedures for arrhythmias
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Cost & Coverage

Average Cost: $20 - $100 per 30 tablets (160mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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.