Sotalol AF 160mg Tablets

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

Urgent Side Effects: Seek Medical Help Right Away

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 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. If you experience any of the following symptoms, contact your doctor 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 if they persist or bother you, contact your doctor:

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

This is not an exhaustive list of possible 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.
Certain health conditions, such as:
+ Asthma or other lung and breathing 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, inform your doctor if you are breast-feeding, as you should not breast-feed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health 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
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
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 laboratory 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 particularly higher in individuals with diabetes, children, and those who are fasting, including people undergoing surgery, experiencing reduced appetite, or vomiting. If you have concerns, discuss them with your doctor.

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

Fluid Loss and Electrolyte Imbalance
Notify your doctor if you experience fluid loss, excessive sweating, vomiting, diarrhea, decreased appetite, or unusual thirst.

Stopping the Medication
Do not abruptly stop taking this medication, 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. Immediately contact your doctor if you experience new or worsening chest pain or other heart problems.

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 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, 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, ibutilide)
• Phenothiazines (e.g., thioridazine, chlorpromazine)
• Tricyclic antidepressants (e.g., amitriptyline, imipramine)
• Macrolide antibiotics (e.g., erythromycin, clarithromycin)
• Fluoroquinolone antibiotics (e.g., moxifloxacin, levofloxacin)
• Other drugs known to prolong the QT interval and/or cause Torsade de Pointes (e.g., cisapride, bepridil, haloperidol, pimozide, sparfloxacin)
• Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B) unless electrolyte imbalance is corrected.

• Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and hypotension.
• Other beta-blockers (e.g., propranolol, metoprolol): Additive beta-blocking effects, increased risk of bradycardia and hypotension.
• Digoxin: Increased risk of bradycardia and AV block.
• Insulin and oral hypoglycemics: Sotalol may mask symptoms of hypoglycemia (e.g., tachycardia).
• Clonidine: May potentiate rebound hypertension upon clonidine withdrawal.
• Reserpine, guanethidine, alpha-methyldopa: May cause excessive reduction of sympathetic tone, leading to bradycardia, hypotension, syncope.

• Antacids containing aluminum or magnesium: May reduce sotalol absorption; administer sotalol at least 2 hours before antacids.
• Diuretics (non-potassium sparing): May cause hypokalemia or hypomagnesemia, increasing risk of Torsade de Pointes.

• Not many specific minor interactions; general caution with drugs affecting heart rate or blood pressure.

• Dizziness
• Lightheadedness
• Syncope (fainting)
• Palpitations (new or worsening)
• Shortness of breath
• Chest pain
• Swelling in ankles or feet (signs of heart failure)
• Unusual fatigue
• Signs of hypoglycemia (e.g., sweating, tremor, anxiety - note: sotalol may mask tachycardia)

Sotalol is Pregnancy Category C. 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 breast milk. The decision to discontinue nursing or discontinue the drug should take into account the importance of the drug to the mother. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypoglycemia).

Safety and efficacy of Sotalol AF for atrial fibrillation/flutter have not been established in pediatric patients. While sotalol is used off-label for other pediatric arrhythmias, specific dosing and safety for AF/AFL in children are not defined.

Elderly patients are at increased risk of adverse effects, particularly Torsade de Pointes, due to age-related decline in renal function. Dosing should be initiated cautiously with careful monitoring of renal function and QTc interval. Lower initial doses and slower titration may be necessary.

• Sotalol AF initiation and dose escalation require hospitalization with continuous ECG monitoring due to the significant risk of Torsade de Pointes.
• Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize TdP risk.
• Strict adherence to renal dose adjustments is crucial, as sotalol is primarily renally eliminated.
• Do not abruptly discontinue sotalol, as this can exacerbate angina, myocardial infarction, or ventricular arrhythmias.
• Sotalol has both Class II (beta-blocker) and Class III (potassium channel blocker) antiarrhythmic properties.
• The 160mg tablet strength is a common maintenance dose for AF/AFL, but titration from 80mg BID is standard.

• Other Class III antiarrhythmics (e.g., amiodarone, dofetilide, dronedarone)
• Class Ic antiarrhythmics (e.g., flecainide, propafenone) - generally avoided in structural heart disease
• Beta-blockers (e.g., metoprolol, carvedilol) - for rate control
• Calcium channel blockers (e.g., diltiazem, verapamil) - for rate control
• Digoxin - for rate control
• Catheter ablation
• Electrical cardioversion

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further 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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.