Sotalol AF 120mg Tablets

Sotalol is a non-selective beta-adrenergic receptor blocker (Class II antiarrhythmic activity) and also prolongs the cardiac action potential and refractoriness in all cardiac tissues (Class III antiarrhythmic activity). It blocks potassium channels responsible for repolarization, thereby prolonging the QT interval.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
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. Contact your doctor or seek medical help if you experience:

Dizziness, fatigue, or weakness
Headache
Diarrhea, nausea, or vomiting

These are not all the possible side effects that may occur. 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 (weak heart)
+ Abnormal heart rhythms, including heart block or sick sinus syndrome
+ Slow heartbeat
Low levels of potassium or magnesium in your blood
Use of medications for irregular heartbeats
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, 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
Natural products and vitamins you are using
Any health problems you have

Do not start, stop, or change the dose of any medication without consulting your doctor first. This will help you avoid potential interactions and ensure that it is safe to take this medication with your other medications and health conditions.

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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise 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. 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 reduced appetite, or vomiting. If you have questions, consult with your doctor. If you have diabetes, closely monitor your blood sugar levels.

Managing Diabetes and Fluid Loss
If you experience fluid loss, unusual sweating, vomiting, diarrhea, decreased appetite, or excessive thirst, inform your doctor.

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 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. Discuss this with your doctor.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. 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, consult 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.

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.

• Drugs that prolong the QT interval (e.g., Class Ia and Class III antiarrhythmics, phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones, cisapride, bepridil, pimozide)
• Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives in excess)

• Other beta-blockers (additive bradycardia, hypotension)
• Calcium channel blockers (non-dihydropyridine, e.g., verapamil, diltiazem - additive negative inotropic and chronotropic effects, risk of AV block)
• Digoxin (additive bradycardia, increased risk of proarrhythmia if hypokalemia occurs)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, potentiation of hypoglycemia)
• Clonidine (rebound hypertension upon withdrawal of clonidine if sotalol is not tapered)
• Drugs affecting renal function (e.g., NSAIDs, cyclosporine - may alter sotalol excretion)

• Alpha-1 blockers (e.g., prazosin - increased risk of first-dose hypotension)
• Antacids containing aluminum or magnesium (decreased sotalol absorption if taken concurrently)
• Neuromuscular blockers (prolongation of block)
• Sympathomimetics (e.g., epinephrine - attenuated response to epinephrine, risk of hypertension and bradycardia)

• Alcohol (may enhance hypotensive effect)

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

Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sotalol crosses the placenta.

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.

Sotalol AF is not indicated for pediatric patients with atrial fibrillation. Sotalol (non-AF) is used for other pediatric arrhythmias, but dosing and monitoring are complex and require specialist supervision.

Elderly patients may have reduced renal function, which can lead to increased sotalol levels and a higher risk of adverse effects, particularly proarrhythmia. Careful dose titration and frequent monitoring of renal function and QTc are essential.

• Sotalol AF initiation and dose escalation must occur in a facility capable of continuous ECG monitoring and resuscitation, typically for at least 3 days or until QTc is stable on the maintenance dose.
• Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize the risk of Torsade de Pointes.
• Renal function is the primary determinant of sotalol clearance; dose adjustments are critical in patients with impaired renal function.
• Avoid concomitant use with other drugs known to prolong the QT interval.
• Patients should be instructed not to abruptly discontinue sotalol due to the risk of exacerbation of angina, myocardial infarction, or ventricular arrhythmias.
• Sotalol has both beta-blocking and Class III antiarrhythmic effects, which contribute to its efficacy but also its side effect profile.

• Amiodarone (Class III antiarrhythmic)
• Dronedarone (Class III antiarrhythmic)
• Flecainide (Class Ic antiarrhythmic)
• Propafenone (Class Ic antiarrhythmic)
• Dofetilide (Class III antiarrhythmic)
• Catheter ablation (non-pharmacological)
• Electrical cardioversion (non-pharmacological)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. 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 for more information. If you have any questions or concerns about your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.