Sotalol 80mg Tablets

Sotalol is a non-selective beta-adrenergic receptor blocker (Class II antiarrhythmic) and a potassium channel blocker (Class III antiarrhythmic). Its Class II effects include reduction of heart rate, myocardial contractility, and AV nodal conduction. Its Class III effects involve prolongation of the cardiac action potential duration and refractoriness in all cardiac tissues by blocking the delayed rectifier potassium current (IKr). This combined action contributes to its antiarrhythmic efficacy.

Serious 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 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
Swelling in the arms or legs that is new or worsening

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, stomach upset, 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. 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
+ Slow heartbeat
Low levels of potassium or magnesium in your blood
Use of medications for abnormal heart rhythms
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 medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
* Any health problems you have

This information will help your doctor determine if it is safe for you 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 Precautions

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 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 abnormal eating patterns, 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. 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 suddenly stop taking this medication, 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 using 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, halofantrine, mizolastine, pentamidine, terfenadine, astemizole)
• Calcium channel blockers (e.g., verapamil, diltiazem) that depress myocardial contractility or AV conduction
• Other beta-blockers
• Hypokalemia or hypomagnesemia-inducing agents (e.g., loop diuretics, thiazide diuretics, laxatives) without correction of electrolyte imbalance
• Anesthesia with agents that depress myocardial function (e.g., cyclopropane, trichloroethylene, ether)

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

• NSAIDs (may reduce antihypertensive effect)
• Alpha-blockers (e.g., prazosin, tamsulosin - increased risk of first-dose hypotension)
• Antacids containing aluminum or magnesium (decreased sotalol absorption if taken concurrently; separate administration by at least 2 hours)
• Cimetidine (increased sotalol bioavailability)

• Alcohol (may enhance hypotensive effect)

• Dizziness
• Lightheadedness
• Syncope (fainting)
• Palpitations (new or worsening)
• Shortness of breath
• Chest pain
• Fatigue
• Bradycardia (slow heart rate)
• Edema (swelling)

Sotalol is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Limited human data suggest no increased risk of major birth defects. However, sotalol crosses the placenta and can cause bradycardia, hypoglycemia, and respiratory depression in the neonate. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Sotalol is excreted into breast milk in significant amounts. Due to the potential for serious adverse effects in the breastfed infant (e.g., bradycardia, hypoglycemia, respiratory depression), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Use in pediatric patients is off-label for most indications, but it is used for supraventricular and ventricular arrhythmias. Dosing is weight-based and requires careful titration and monitoring due to the risk of proarrhythmia and other adverse effects. Renal function must be carefully assessed.

Elderly patients may be more susceptible to the adverse effects of sotalol, particularly bradycardia, hypotension, and proarrhythmia (Torsade de Pointes), due to age-related decline in renal function and increased sensitivity to beta-blockade. Dose adjustment based on renal function is crucial. Initiate at lower doses and titrate slowly with close monitoring.

• Sotalol has both Class II (beta-blocker) and Class III (potassium channel blocker) antiarrhythmic properties.
• Due to the risk of Torsade de Pointes, sotalol initiation and dose escalation must occur in a hospital setting with continuous ECG monitoring for at least 2-3 days.
• Baseline QTc interval, serum potassium, and magnesium levels must be within normal limits and corrected if abnormal before starting sotalol.
• Renal function is critical for dosing; sotalol is almost exclusively renally eliminated. Dose adjustments are mandatory for CrCl <60 mL/min.
• Avoid concomitant use with other QT-prolonging drugs.
• Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, as it can exacerbate angina or precipitate myocardial infarction.
• Patients should be educated on symptoms of bradycardia, hypotension, and proarrhythmia and instructed to seek immediate medical attention if they occur.

• Other Class III antiarrhythmics (e.g., Amiodarone, Dofetilide, Dronedarone)
• Other Class II antiarrhythmics (e.g., Metoprolol, Atenolol, Propranolol)
• Class IC antiarrhythmics (e.g., Flecainide, Propafenone - for AFib/AFlutter)
• Calcium channel blockers (e.g., Diltiazem, Verapamil - for rate control in AFib/AFlutter)
• Digoxin (for rate control in AFib/AFlutter)
• Catheter ablation (for various arrhythmias)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.