Sotalol 120mg Tablets

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 potassium channels, and it also reduces heart rate and myocardial contractility by blocking beta-adrenergic receptors.

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 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. If you experience any of the following symptoms, seek medical attention 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, nausea, or vomiting

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

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 your medications, including:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins

Share information about all your health problems with your doctor and pharmacist to verify that it is safe to take this medication with your existing conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.

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 blood work done as directed by your doctor, and discuss the results with them. An electrocardiogram (ECG) is required before starting this medication and during treatment; consult with your doctor about this.

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

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

Diabetes Management
If you have high blood sugar (diabetes), it is crucial to monitor your blood sugar levels closely 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 and, in some cases, heart attack. The risk is greater if you have certain types of heart disease. To avoid side effects, your doctor will 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 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 have a higher risk of side effects; discuss this with your doctor.

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

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

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, AV block, hypotension
• Digoxin - additive bradycardia, increased digoxin levels
• Other beta-blockers - additive beta-blockade effects (bradycardia, hypotension)
• Insulin and oral hypoglycemics - masking of hypoglycemia symptoms (tachycardia, tremors)
• Clonidine - risk of rebound hypertension upon clonidine withdrawal if sotalol is not tapered first

• Alpha-1 blockers (e.g., prazosin) - increased risk of first-dose hypotension
• NSAIDs - may reduce antihypertensive effect of sotalol
• Cimetidine - may increase sotalol bioavailability
• Aluminum/magnesium-containing antacids - may reduce sotalol absorption

• Not available

• Dizziness
• Lightheadedness
• Syncope (fainting)
• Palpitations (new or worsening)
• Shortness of breath
• Chest pain
• Fatigue
• Swelling of ankles/feet

Sotalol is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sotalol crosses the placenta.

Sotalol is excreted into breast milk. The American Academy of Pediatrics considers sotalol to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypoglycemia).

Safety and efficacy have not been established for most pediatric indications. Use in children is generally off-label and requires highly individualized dosing and close monitoring due to varying pharmacokinetics and increased sensitivity to adverse effects.

Elderly patients are at increased risk of adverse effects, particularly proarrhythmia, due to age-related decline in renal function. Dose adjustments based on creatinine clearance are crucial. Initiate with lower doses and titrate slowly with careful monitoring.

• Initiation and dose escalation of sotalol (Betapace AF and Sorine) for AFib/AFL must occur in a hospital setting with continuous ECG monitoring for at least 3 days to assess QTc prolongation and risk of Torsade de Pointes.
• Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize the risk of proarrhythmia.
• Sotalol should be taken on an empty stomach (at least 1 hour before or 2 hours after meals) to ensure consistent absorption.
• Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, as it can exacerbate angina or precipitate myocardial infarction.
• Regular monitoring of QTc interval, serum electrolytes (K+, Mg2+), heart rate, blood pressure, and renal function is essential throughout therapy.
• Patients should be educated on symptoms of proarrhythmia (e.g., syncope, severe dizziness, palpitations) and instructed to seek immediate medical attention if they occur.

• Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• 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 procedures
• Cardioversion

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; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 details about the overdose, including the substance taken, the amount, and the time it occurred.