Betapace AF 160mg 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. This Class III effect is dose-dependent and contributes to its antiarrhythmic efficacy, but also to its proarrhythmic potential (Torsade de Pointes). The beta-blocking effects contribute to heart rate reduction and blood pressure lowering.

Urgent Side Effects: Seek Medical Attention Immediately

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 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

Additionally, this medication may increase the risk of heart failure, particularly in people with pre-existing heart disease. If you have heart disease, inform your doctor. 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 or may only have mild symptoms. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, such as:
+ Asthma or other lung or breathing problems that cause shortness of breath or wheezing
+ Heart failure (weak heart)
+ Abnormal heartbeats, 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, inform your doctor if you are breast-feeding, as you should not breast-feed while taking this medication.

This is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure it is safe to take this medication. 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 performing tasks 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 position, and exercise caution 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. You will need to undergo an electrocardiogram (ECG) 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 laboratory personnel that you are taking this medication.

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

Diabetes Management
If you have high blood sugar (diabetes), it is crucial to closely monitor your blood sugar levels. 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 worsening 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 discontinue the 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 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.

• Drugs that prolong the QT interval (e.g., Class IA and Class III antiarrhythmics, phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones, cisapride, pimozide)
• Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B) unless electrolyte imbalances are corrected
• Severe renal impairment (CrCl < 20 mL/min)
• Bronchial asthma or chronic obstructive pulmonary disease (COPD)
• Sinus bradycardia (<50 bpm), sick sinus syndrome, second- or third-degree AV block (unless functioning pacemaker is present)
• Congenital or acquired long QT syndrome
• Cardiogenic shock, uncontrolled heart failure
• Anesthesia that produces myocardial depression

• Other beta-blockers (additive bradycardia, hypotension)
• Calcium channel blockers (e.g., verapamil, diltiazem - additive bradycardia, AV block, myocardial depression)
• Digoxin (additive bradycardia, increased risk of proarrhythmia if hypokalemia occurs)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms)
• Clonidine (rebound hypertension upon withdrawal of clonidine)
• Non-steroidal anti-inflammatory drugs (NSAIDs) (may reduce antihypertensive effect)
• Sympathomimetics (e.g., epinephrine, norepinephrine - may cause hypertension, bradycardia)

• Antacids containing aluminum or magnesium (decreased sotalol absorption if taken concurrently; separate administration by at least 2 hours)
• Reserpine, guanethidine (additive hypotensive/bradycardic effects)
• Neuromuscular blockers (prolonged blockade)

• Not available

• Palpitations (may indicate proarrhythmia or recurrence of AFib)
• Dizziness, lightheadedness, syncope (may indicate bradycardia, hypotension, or Torsade de Pointes)
• Shortness of breath, fatigue, swelling (signs of worsening heart failure)
• Chest pain
• Wheezing, difficulty breathing (bronchospasm)
• Cold extremities, numbness, tingling (peripheral vasoconstriction)
• Unusual tiredness or weakness
• Changes in vision

Category C. Sotalol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placenta. Neonates of mothers treated with sotalol near term may be at risk for bradycardia, hypoglycemia, and other beta-blocker effects.

Sotalol is excreted into breast milk in significant amounts. Due to the potential for serious adverse reactions in the breastfed infant (e.g., bradycardia, hypotension, hypoglycemia), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. The American Academy of Pediatrics considers sotalol to be a drug for which the effect on nursing infants is unknown but may be of concern.

Safety and effectiveness in pediatric patients for atrial fibrillation/flutter have not been established. Use in pediatric patients for life-threatening ventricular arrhythmias is off-label and requires specialized dosing and monitoring due to increased risk of proarrhythmia and variable pharmacokinetics.

Elderly patients may have reduced renal function, which can lead to increased sotalol levels and a higher risk of adverse effects, particularly Torsade de Pointes. Dose adjustments based on creatinine clearance are crucial. Initiate at lower doses and titrate slowly with careful monitoring.

• Sotalol is unique among antiarrhythmics as it possesses both non-selective beta-blocking (Class II) and potassium channel blocking (Class III) properties.
• The most critical aspect of sotalol therapy is the risk of Torsade de Pointes (TdP), which is dose-related and increased by hypokalemia, hypomagnesemia, and prolonged baseline QTc.
• Initiation and re-initiation of sotalol (Betapace AF) MUST occur in a hospital setting with continuous ECG monitoring for at least 3 days at each dose level to monitor for QTc prolongation and proarrhythmia.
• Always correct hypokalemia and hypomagnesemia BEFORE initiating sotalol.
• Food significantly reduces sotalol absorption; instruct patients to take it on an empty stomach.
• Renal function is paramount for dosing; sotalol is primarily renally eliminated and contraindicated in severe renal impairment (CrCl < 20 mL/min).
• Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, due to the risk of exacerbating angina or myocardial infarction (beta-blocker withdrawal syndrome).

• Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• Other beta-blockers (e.g., metoprolol, carvedilol - primarily for rate control, not rhythm control as Class III)
• Calcium channel blockers (e.g., diltiazem, verapamil - primarily for rate control)
• Digoxin (primarily for rate control)
• Catheter ablation (non-pharmacological)
• Cardioversion (non-pharmacological)

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.