Sotalol Hcl 150mg/10ml Inj, 10ml

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 the delayed rectifier potassium current (IKr). It also reduces heart rate, myocardial contractility, and AV nodal conduction.

Serious Side Effects: Seek Medical Help 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 attention 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
Heart failure, which can occur even if you have no prior history of heart disease. If you have a history of 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
Injection site reactions, such as pain, irritation, or swelling

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you encounter any of the following side effects or any other symptoms that concern you or do not resolve, contact your doctor or seek medical attention:

Dizziness, fatigue, or weakness
Headache
Diarrhea, nausea, or vomiting

Reporting Side Effects

This list is not exhaustive, and you may experience other 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 and its symptoms.
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 specific 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 prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history

Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so. This will help prevent potential interactions and ensure the safe use of this medication.

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. Additionally, have your blood work checked as directed by your doctor. Discuss any concerns or questions with your doctor.

Electrocardiogram (ECG) Monitoring
You will need to undergo an ECG before starting this medication and during treatment. Consult with your doctor about this requirement.

Impact on Lab Tests
This medication may affect certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Low Blood Sugar Risk
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, undergoing surgery, or experiencing vomiting. If you have questions or 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
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 minimize side effects, your doctor will instruct you on how to gradually stop taking this medication. Seek immediate medical attention 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 risk of an even more severe reaction. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.

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, dronedarone)
• Other drugs that prolong the QT interval (e.g., phenothiazines, tricyclic antidepressants, macrolide antibiotics, fluoroquinolones, cisapride, bepridil)
• Drugs that cause hypokalemia or hypomagnesemia (e.g., loop diuretics, thiazide diuretics, laxatives, amphotericin B IV) unless electrolyte imbalance is corrected
• Calcium channel blockers (e.g., verapamil, diltiazem) due to risk of severe bradycardia, AV block, and hypotension
• Other beta-blockers

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

• NSAIDs (may reduce hypotensive effect)
• Sympathomimetics (e.g., epinephrine, norepinephrine, isoproterenol) (attenuation of beta-agonist effects, risk of hypertension and bradycardia)
• Cimetidine, ranitidine (may increase sotalol levels slightly)

• Antacids (may reduce oral sotalol absorption, but not relevant for IV)

• Palpitations
• Dizziness
• Lightheadedness
• Syncope
• Shortness of breath
• Swelling of ankles/feet
• Chest pain
• Fatigue
• Signs of new or worsening arrhythmia (e.g., irregular heartbeat, skipped beats)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Sotalol crosses the placenta. Neonates of mothers treated with sotalol near term may experience bradycardia, hypoglycemia, and respiratory depression.

Sotalol is excreted into breast milk. The American Academy of Pediatrics considers sotalol to be compatible with breastfeeding, but infant monitoring for bradycardia, hypoglycemia, and other beta-blocker effects is recommended, especially in preterm or neonates.

Safety and efficacy in pediatric patients have not been established for the IV formulation. Oral sotalol is used in pediatric patients for certain arrhythmias, but dosing is complex and requires specialized expertise.

Elderly patients may have reduced renal function, requiring dose adjustment. They may also be more susceptible to adverse effects like bradycardia, hypotension, and proarrhythmia. Careful monitoring of QTc, heart rate, blood pressure, and renal function is crucial.

• Sotalol has both beta-blocking and Class III antiarrhythmic properties, making it unique.
• Always initiate or re-initiate sotalol in a hospital setting with continuous ECG monitoring for at least 3 days (or 6 doses) to monitor for QTc prolongation and proarrhythmia.
• Correct hypokalemia and hypomagnesemia prior to and during sotalol therapy to minimize TdP risk.
• Renal function is critical for dosing; significant dose reduction or contraindication applies to impaired renal function.
• Avoid concomitant use with other QT-prolonging drugs or drugs that cause electrolyte imbalances.
• Do not abruptly discontinue sotalol, especially in patients with ischemic heart disease, due to risk of exacerbation of angina or myocardial infarction.

• Amiodarone (Class III antiarrhythmic)
• Dofetilide (Class III antiarrhythmic)
• Flecainide (Class Ic antiarrhythmic)
• Propafenone (Class Ic antiarrhythmic)
• Beta-blockers (e.g., metoprolol, carvedilol) for rate control
• Calcium channel blockers (e.g., diltiazem, verapamil) for rate control

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time of the incident to ensure prompt and effective treatment.