Betapace AF 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 responsible for repolarization. Its beta-blocking effects include reduction in heart rate and myocardial contractility. The combination of Class II and Class III effects contributes to its antiarrhythmic properties.

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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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 heart rate, 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. 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 any other symptoms that bother you or persist, 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, 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Respiratory issues, such as asthma or other lung and breathing problems that cause shortness of breath or wheezing.
Cardiovascular conditions, including heart failure (weak heart), abnormal heartbeats (heart block or sick sinus syndrome), or a slow heartbeat.
Electrolyte imbalances, specifically low potassium or magnesium levels.
Medications you are taking for abnormal heart rhythms.
Medications that can cause a prolonged QT interval, a type of abnormal heartbeat. There are many medications that can cause this condition, so consult your doctor or pharmacist if you are unsure.

Additionally, inform your doctor if you are breast-feeding, as 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

This information will help your doctor determine if it is safe for you to take this medication with your existing health conditions and medications. 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
Avoid driving and engaging in activities 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 be cautious when climbing stairs.

Monitoring Your Condition
Regularly check your blood pressure and heart rate as instructed by your doctor. 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 or concerns, discuss them with your doctor.

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

• Class Ia antiarrhythmics (e.g., disopyramide, quinidine, procainamide)
• Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• Other beta-blockers
• Drugs that prolong the QT interval (e.g., phenothiazines, tricyclic antidepressants, macrolide antibiotics like erythromycin, fluoroquinolone antibiotics like moxifloxacin, cisapride, pimozide)
• Calcium channel blockers (e.g., verapamil, diltiazem) due to additive negative inotropic and chronotropic effects
• Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B) unless electrolyte imbalance is corrected

• Digoxin (increased risk of bradycardia, AV block)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms)
• Clonidine (risk of rebound hypertension upon withdrawal of clonidine)
• Reserpine, guanethidine (additive hypotensive and bradycardic effects)
• Neuromuscular blocking agents (prolongation of block)

• Antacids containing aluminum or magnesium (may reduce sotalol absorption if taken concurrently)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (may reduce hypotensive effect)
• Cimetidine (may increase sotalol levels by reducing renal clearance)
• Rifampin (may decrease sotalol levels)

• Not available

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

Sotalol is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, 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.

Sotalol is excreted into human breast milk in significant amounts. Due to the potential for serious adverse reactions in the nursing 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.

Safety and effectiveness of Betapace AF in pediatric patients have not been established for AF/AFL. While sotalol has been used off-label for other pediatric arrhythmias, specific dosing and monitoring guidelines for AF/AFL are not available. Use in children requires careful consideration by a pediatric cardiologist.

Elderly patients are more likely to have decreased renal function, which can lead to increased sotalol levels and an increased risk of adverse effects, particularly proarrhythmia. Dose adjustments based on creatinine clearance are crucial. Close monitoring for bradycardia, hypotension, and QTc prolongation is essential.

• Betapace AF is specifically indicated for the maintenance of normal sinus rhythm in patients with symptomatic AF/AFL who are currently in sinus rhythm. It is NOT indicated for patients with asymptomatic AF/AFL or for initial conversion of AF/AFL.
• Initiation and dose escalation of Betapace AF must occur in a hospital setting with continuous ECG monitoring for at least 3 days or until steady-state QTc is achieved on the maintenance dose.
• Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy, as these electrolyte imbalances significantly increase the risk of Torsade de Pointes.
• Renal function must be assessed prior to initiation and periodically thereafter. Sotalol is contraindicated in patients with CrCl <40 mL/min for AF/AFL indication.
• Patients should be instructed to take sotalol on an empty stomach, 1 hour before or 2 hours after meals, and to avoid dairy products within 2 hours of dosing.
• 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. Tapering is recommended.
• Monitor for signs of heart failure exacerbation, as sotalol has negative inotropic effects.

• Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• Other beta-blockers (e.g., metoprolol, carvedilol, atenolol) for rate control or other arrhythmias
• 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'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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.