Sotalol

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Generic Name: Sotalol Brand Name(s): Generics only. No brands available.

Uses

What is Sotalol used for?

Sotalol is used to treat a serious (possibly life-threatening) type of fast heartbeat called sustained ventricular tachycardia. It is also used to treat certain fast/irregular heartbeats (atrial fibrillation/flutter) in patients with severe symptoms such as weakness and shortness of breath. Sotalol helps to lessen these symptoms. It slows the heart rate and helps the heart to beat more normally and regularly. This medication is both a beta blocker and an anti-arrhythmic.

How should I take Sotalol?

Take this medication by mouth as directed by your doctor, usually once or twice a day. You may take it with or without food, but it is important to choose one way and take it the same way with each dose.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

Dosage is based on your medical condition and response to treatment. In children, dosage is also based on age, height, and weight.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

If you use antacids containing aluminum or magnesium, do not take them at the same time as sotalol. These antacids can bind to sotalol and decrease its absorption and effectiveness. Separate doses of these antacids and sotalol by at least 2 hours to reduce this interaction.

Do not take more of this drug than prescribed because you may increase your risk of side effects, including a new serious abnormal heartbeat. Do not take less of this medication or skip doses unless directed by your doctor. Your fast/irregular heartbeat is more likely to return if you do not take sotalol properly. Also, do not run out of this medication. Order your refills several days early to avoid running out of pills.

Tell your doctor if your condition does not improve or if it worsens.

How do I store Sotalol?

Sotalol is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Sotalol in the bathroom or the freezer. There may be different brands of Sotalol that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Sotalol down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Sotalol?

Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block unless you have a heart pacemaker), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, treated stable heart failure, very recent heart attack (within 2 weeks), other irregular heartbeat problems (such as sick sinus syndrome), overactive thyroid disease (hyperthyroidism), serious allergic reactions needing treatment with epinephrine.

Sotalol may cause a condition that affects the heart rhythm (QT prolongation in the EKG). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sotalol, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (QT prolongation in the EKG, history of torsade de pointes), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”), if you are unable to eat or drink fluids as you normally would, or if you have conditions such as severe/prolonged sweating, diarrhea, or vomiting. Talk to your doctor about using sotalol safely.

If you have diabetes, this product may mask the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness and sweating, are unaffected by this drug. This product may also make it harder to control your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, tiredness, and QT prolongation.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Sotalol during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Sotalol. Sotalol is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Sotalol?

Tiredness, slow heartbeat, and dizziness may occur. Less common side effects include headache, diarrhea, and decreased sexual ability. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Seek immediate medical attention if any of these unlikely but serious side effects occur: severe dizziness, fainting, sudden change in heartbeat (unusually faster/slower/more irregular), chest/jaw/left arm pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Sotalol?

A product that may interact with this drug is: fingolimod.

Many drugs besides sotalol may affect the heart rhythm (QT prolongation in the EKG), including amiodarone, disopyramide, dofetilide, pimozide, procainamide, quinidine, macrolide antibiotics (such as clarithromycin, erythromycin), among others.

Some products have ingredients that could raise your heart rate. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

This medication may interfere with certain medical/laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Sotalol may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Sotalol?

Sotalol may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Sotalol?

Sotalol may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Sotalol.

What is the dose of Sotalol for an adult?

Usual Adult Dose for Atrial Fibrillation

Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):

-Initial dose: 80 mg orally 2 times a day

-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.

-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).

-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.

Comment:

-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL [BETAPACE AF (R)}: (ATRIAL FIBRILLATION):

-(STEP 1) Electrocardiographic assessment: Prior to administration of the first dose, the CrCl and the QT interval should be determined. If the baseline QT is greater than 450 msec, Betapace AF (R) is contraindicated:

-(STEP 2): Calculate the CrCl for the patient.

-(STEP 3):

Initial dose:

-If the CrCl is less than 40 mL/day: Betapace AF (R) is contraindicated

-If the CrCl is 40 to 60 mL/min: 80 mg once a day

-If the CrCl is greater than 60 mL/min: 80 mg orally 2 times a day

-(STEP 4): Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

-(STEP 5); If the 80 mg dose level is tolerated and the QT interval remains less than 500 msec after at least 3 days (after 5 or 6 doses if patient receiving once-daily dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg twice daily and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving once-daily dosing).

-If the 80 mg dose level (given twice a day or once-daily depending upon CrCl) does not reduce the frequency of relapses of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (i.e., greater than or equal to 520 msec), the dose level may be increased to 120 mg (twice a day or once-daily depending upon CrCl).

-If the 120 mg dose does not reduce the frequency of early relapse of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (greater than or equal to 520 msec), an increase to 160 mg (2 times a day or daily) depending upon CrCl), can be considered.

-Any increases in dosage should be done in a step-wise fashion as outlined above.

-Maintenance dose: 120 to 160 mg orally 2 times a day. Renal function and QT should be reevaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is greater than 100 msec), the dose should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is greater than or equal to 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued.

PARENTERAL:

-Initial: 112.5 mg IV once or twice daily

-Maintenance: 112.5 to 150 mg IV once or twice daily

-If 112.5 mg IV once or twice daily, at steady state, does not reduce the frequency of early relapse of arrhythmia and is tolerated without excessive QTc prolongation (greater than 520 msec), increase the dose to 150 mg IV once or twice daily.

-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: For the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Usual Adult Dose for Atrial Flutter

Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):

-Initial dose: 80 mg orally 2 times a day

-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.

-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).

-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.

Comment:

-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL [BETAPACE AF (R)}: (ATRIAL FIBRILLATION):

-(STEP 1) Electrocardiographic assessment: Prior to administration of the first dose, the CrCl and the QT interval should be determined. If the baseline QT is greater than 450 msec, Betapace AF (R) is contraindicated:

-(STEP 2): Calculate the CrCl for the patient.

-(STEP 3):

Initial dose:

-If the CrCl is less than 40 mL/day: Betapace AF (R) is contraindicated

-If the CrCl is 40 to 60 mL/min: 80 mg once a day

-If the CrCl is greater than 60 mL/min: 80 mg orally 2 times a day

-(STEP 4): Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

-(STEP 5); If the 80 mg dose level is tolerated and the QT interval remains less than 500 msec after at least 3 days (after 5 or 6 doses if patient receiving once-daily dosing), the patient can be discharged. Alternatively, during hospitalization, the dose can be increased to 120 mg twice daily and the patient followed for 3 days on this dose (followed for 5 or 6 doses if patient receiving once-daily dosing).

-If the 80 mg dose level (given twice a day or once-daily depending upon CrCl) does not reduce the frequency of relapses of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (i.e., greater than or equal to 520 msec), the dose level may be increased to 120 mg (twice a day or once-daily depending upon CrCl).

-If the 120 mg dose does not reduce the frequency of early relapse of atrial fibrillation/atrial flutter and is tolerated without excessive QT interval prolongation (greater than or equal to 520 msec), an increase to 160 mg (2 times a day or daily) depending upon CrCl), can be considered.

-Any increases in dosage should be done in a step-wise fashion as outlined above.

-Maintenance dose: 120 to 160 mg orally 2 times a day. Renal function and QT should be reevaluated regularly if medically warranted. If QT is 520 msec or greater (JT 430 msec or greater if QRS is greater than 100 msec), the dose should be reduced and patients should be carefully monitored until QT returns to less than 520 msec. If the QT interval is greater than or equal to 520 msec while on the lowest maintenance dose level (80 mg) the drug should be discontinued.

PARENTERAL:

-Initial: 112.5 mg IV once or twice daily

-Maintenance: 112.5 to 150 mg IV once or twice daily

-If 112.5 mg IV once or twice daily, at steady state, does not reduce the frequency of early relapse of arrhythmia and is tolerated without excessive QTc prolongation (greater than 520 msec), increase the dose to 150 mg IV once or twice daily.

-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: For the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm.

Usual Adult Dose for Ventricular Arrhythmia

Usual Adult Dose: Ventricular Arrhythmia:

(CA, US):

Note: The generic form of this drug is used for atrial fibrillation or ventricular arrhythmia. The trade name Betapace (R) is for ventricular arrhythmia only and the trade name Betapace AF (R) is for atrial fibrillation only. These two trade names are not interchangeable.

SOTALOL: (ATRIAL FIBRILLATION, VENTRICULAR ARRHYTHMIA):

-Initial dose: 80 mg orally 2 times a day

-Doses should be adjusted gradually every 3 days in order to attain steady state plasma concentrations and allow for monitoring of QT intervals.

-Maintenance dose: The initial dose may be increased, if needed, to 240 or 320 mg orally per day (120 to 160 mg orally 2 times a day).

-Some patients with life-threatening refractory ventricular arrhythmias may require 480 to 640 mg per day in divided doses.

Comment:

-Because of the long terminal elimination half-life of this drug, dosing on more than a twice a day regimen is usually not necessary.

ORAL (BETAPACE): (VENTRICULAR ARRHYTHMIA):

-Initial: 80 mg twice daily

-The initial dose may be increased 120 to 160 mg twice daily. The dosage should be adjusted gradually allowing 3 days between dosing increments in order to attain steady-state plasma concentrations and to allow monitoring of QT intervals. Graded dose adjustment will help prevent doses that are higher than necessary to control the arrhythmia. Most patients obtain a therapeutic response with a total daily dose of 160 to 320 mg given in two or three divided doses.

PARENTERAL:

-Initial: 75 mg IV infused over 5 hours once or twice daily based on the creatinine clearance.

-Maintenance: 75 to 300 mg infused over 5 hours once or twice daily based on the creatinine clearance.

-The dose may be increased in increments of 75 mg/day every 3 days. Doses as high as 225 or 300 mg IV have been utilized in patients with refractory life-threatening arrhythmias.

-Start IV therapy only if the baseline QT interval is less than 450 msec. During initiation and titration, monitor the QT interval after the completion of each infusion. If the QT interval prolongs to 500 msec or greater, reduce the dose, decrease the infusion rate, or discontinue the drug.

Use: Documented life-threatening ventricular arrhythmia

Renal Dose Adjustments

Adults:

Oral [Betapace(R)]:

-CrCl less than 10 mL/min: Dose should be individualized

-CrCl 10 to 29 mL/min: The dosage interval should be increased to 36 to 48 hours.

-CrCl 30 to 59 mL/min: The dosage interval should be increased to 24 hours.

-CrCl greater than 60 mL/min: The dosage interval should be decreased to 12 hours.

Oral [Betapace AF (R)]:

-CrCl less than 40 mL/min: Contraindicated

-CrCl 40 to 60 mL/min: 80 mg every 24 hours

Parenteral:

-CrCl less than 40 mL/min: Contraindicated

-CrCl 40 to 60 mL/min: The dosage interval should be once daily

-CrCl greater than 60 mL/min: The dosage interval should be twice daily

Dose Adjustments

Dose adjustments should be done gradually allowing 2 to 3 days between dosing increments.

Dialysis

Extreme caution should be exercised in patients with renal failure undergoing hemodialysis. The half-life of this drug is prolonged (up to 69 hours) in anuric patients. However, this drug can be partly removed by dialysis with subsequent partial rebound in concentrations when dialysis is completed. Both safety (heart rate, QT interval) and efficacy (arrhythmia control) should be closely monitored.

Other Comments

Sotalol is available as the trade name Betapace and Betapace AF. These two trade names have different indications and one product should never be substituted for the other product because of significant differences in labeling (i.e., indications, dosing administration, safety information, and patient package insert information).

Administration advice:

-This drug should be given 1 to 2 hours before food.

-Dosing on more than a twice daily regimen is not usually necessary.

Patient advice:

-Patients should be instructed NOT to double the next dose if a dose is missed. The next dose should be taken at the usual time.

What is the dose of Sotalol for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Sotalol available?

Sotalol is available in the following dosage forms and strengths:

  • Oral tablet,
  • Oral solution,
  • Intravenous solution.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Sotalol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: April 27, 2018 | Last Modified: April 27, 2018

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