Betapace 160mg Tablets

Sotalol is a non-selective beta-adrenergic receptor blocker that also possesses Class III antiarrhythmic properties. It prolongs the cardiac action potential duration and refractoriness in all cardiac tissues by blocking potassium channels (specifically the delayed rectifier potassium current, IKr). This dual action contributes to its antiarrhythmic effects.

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 a fast or slow heartbeat, or a new or worsening irregular heartbeat
Excessive sweating
Changes in vision
Difficulty getting or maintaining an erection
Heart failure, which can occur in people taking this medication, including those 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 do not go away, contact your doctor or seek medical help:

Dizziness, fatigue, or weakness
Headache
* Diarrhea, stomach upset, or vomiting

This is not an exhaustive list of all 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 you experienced, including any 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 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 and medications. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 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. You will also need to have regular blood tests as directed by your doctor. Additionally, an electrocardiogram (ECG) will be required before starting this medication and during treatment. Discuss any concerns or questions with your doctor.

Interference with Lab Tests
This medication may affect certain laboratory tests. Be sure to 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 is particularly concerning for individuals with diabetes, children, and those who are fasting, undergoing surgery, or experiencing vomiting. If you have questions or concerns, consult your doctor.

Managing Diabetes
If you have high blood sugar (diabetes), it is crucial to closely monitor your blood sugar levels 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 or even a heart attack, especially 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 risk with your doctor.

Allergic Reactions
If you have a history of severe allergic reactions, inform your doctor. 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, consult your doctor, as this medication may reduce the effectiveness of epinephrine.

Special Considerations
Female patients may be at a higher risk of side effects. Discuss this with your doctor. If you are pregnant or plan to become pregnant, you will need to weigh the benefits and risks of taking this medication with your doctor.

• Drugs that prolong QT interval (e.g., Class IA and Class III antiarrhythmics, phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones, cisapride, bepridil)
• Calcium channel blockers (e.g., verapamil, diltiazem) due to additive negative inotropic/chronotropic effects
• Other beta-blockers
• Hypokalemia or hypomagnesemia (uncorrected)
• Sinus bradycardia (<50 bpm), sick sinus syndrome, second- or third-degree AV block (unless with a functioning pacemaker)
• Congenital or acquired long QT syndrome
• Cardiogenic shock, uncontrolled heart failure
• Bronchial asthma or chronic obstructive pulmonary disease (COPD)
• Renal failure (CrCl <20 mL/min)

• Digoxin (increased risk of bradycardia, AV block)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms)
• Clonidine (rebound hypertension upon withdrawal of clonidine)
• Diuretics (increased risk of hypokalemia/hypomagnesemia, exacerbating QT prolongation)
• Drugs affecting renal function (e.g., NSAIDs, cyclosporine)
• Sympathomimetics (e.g., epinephrine, norepinephrine) - may antagonize beta-blocker effects

• Antacids containing aluminum or magnesium (may reduce sotalol absorption)
• Neuromuscular blockers (prolongation of blockade)
• Rifampin (may reduce sotalol levels, though sotalol is minimally metabolized)

• Alcohol (may enhance hypotensive effects)

• Palpitations
• Dizziness
• Lightheadedness
• Syncope
• Shortness of breath
• Chest pain
• Fatigue
• Swelling in ankles/feet (signs of heart failure exacerbation)
• Wheezing or difficulty breathing (bronchospasm)

Sotalol is classified as 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. Sotalol crosses the placenta.

Sotalol is excreted into human 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 to discontinue the drug, taking into account the importance of the drug to the mother. Infant monitoring for signs of beta-blockade is recommended if breastfeeding continues.

Safety and effectiveness in pediatric patients have not been established for all indications. Use in pediatric patients for life-threatening ventricular arrhythmias has been described, but dosing is complex and requires specialized expertise. Not approved for pediatric use in atrial fibrillation/flutter.

Elderly patients may have reduced renal function, leading to increased sotalol exposure and a higher risk of adverse effects, particularly QT prolongation and Torsades de Pointes. Dose adjustments based on creatinine clearance are crucial. Start with lower doses and titrate slowly with careful monitoring.

• Sotalol has a unique dual mechanism: non-selective beta-blockade and Class III antiarrhythmic (potassium channel blockade).
• Initiation and re-initiation of sotalol (especially Betapace AF) must occur in a hospital setting with continuous ECG monitoring for at least 3 days to monitor for QT prolongation and Torsades de Pointes.
• The risk of Torsades de Pointes is dose-dependent and inversely related to creatinine clearance. Renal function must be assessed before and during therapy.
• Hypokalemia and hypomagnesemia must be corrected prior to and during sotalol therapy, as they significantly increase the risk of TdP.
• Avoid concomitant use with other QT-prolonging drugs.
• Do not abruptly discontinue sotalol, as this can exacerbate angina or precipitate myocardial infarction.
• Food, especially dairy products, can reduce sotalol absorption; administer consistently with or without food.

• Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• Other beta-blockers (e.g., metoprolol, carvedilol, atenolol) for rate control or other indications without Class III effects
• Calcium channel blockers (e.g., diltiazem, verapamil) for rate control
• Digoxin for rate control
• Catheter ablation (for certain arrhythmias)
• Implantable cardioverter-defibrillator (ICD) for life-threatening ventricular arrhythmias

If your symptoms or health condition do not improve or worsen over time, 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, as this information will be crucial in determining the best course of treatment.