Generic Name: sotalol AF (SO tuh lol AF)
Brand Names: Betapace AF, Sotalol Hydrochloride AF

What is Sotalol Hydrochloride AF (sotalol AF)?

Sotalol AF is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol AF is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter.

Another form of this medicine, called sotalol, is used to treat heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol AF may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sotalol Hydrochloride AF (sotalol AF)?

You should not use this medication if you are allergic to sotalol AF, or if you have asthma, certain serious heart conditions, a history of “Long QT syndrome,” severe kidney disease, low levels of potassium in your blood, or uncontrolled congestive heart failure.

Before taking sotalol AF, tell your doctor if you have breathing problems, a history of heart disease or congestive heart failure, diabetes, kidney disease, a thyroid disorder, an electrolyte imbalance, or if you have recently had a heart attack.

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

You will receive your first few doses of sotalol AF in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before taking Sotalol Hydrochloride AF (sotalol AF)?

Do not use this medication if you are allergic to sotalol AF, or if you have:

• asthma;

• certain heart conditions, especially “AV block” or “sick sinus syndrome” (unless you have a pacemaker);

• a history of “Long QT syndrome”;

• severe kidney disease;

• low levels of potassium in your blood (hypokalemia); or

• severe or uncontrolled congestive heart failure.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take sotalol AF:

• breathing problems such as bronchitis or emphysema;

• a history of heart disease or congestive heart failure;

• diabetes;

• kidney disease;

• a thyroid disorder;

• an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

• if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol AF can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Sotalol Hydrochloride AF (sotalol AF)?

You will receive your first few doses of sotalol AF in a hospital setting where your heart can be monitored, in case the medication causes serious side effects.

Sotalol AF comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take sotalol AF exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol AF at the same time every day.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any follow-up visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol AF.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

Store sotalol AF at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Call your doctor if you miss more than two doses of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, hunger, weakness, confusion, sweating, slow or fast heartbeats, chest pain, feeling short of breath, fainting, and seizure (convulsions).

What should I avoid while taking Sotalol Hydrochloride AF (sotalol AF)?

Do not take an antacid within 2 hours before or after taking sotalol AF. Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol AF.

Sotalol Hydrochloride AF (sotalol AF) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat, chest pain, shortness of breath;

• feeling light-headed, fainting;

• slow heartbeat;

• unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Less serious side effects may include:

• mild diarrhea, nausea, vomiting;

• headache;

• sleep problems (insomnia); or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sotalol Hydrochloride AF (sotalol AF)?

Tell your doctor about all other medications you use, especially:

• clonidine (Catapres);

• digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

• reserpine;

• a diuretic (water pill);

• drugs that can affect heart rhythm, such as cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

• any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), sotalol (Betapace);

• antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

• a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), and others;

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

• a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

• a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

• medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair).

This list is not complete and there may be other drugs that can interact with sotalol AF. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about sotalol AF.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 09/24/2009 11:03:57 AM.

Generic Name: sodium tetradecyl sulfate (SOO dee um TET ra DES il SUL fate)
Brand Names: Sotradecol

What is Sotradecol (sodium tetradecyl sulfate)?

Sodium tetradecyl sulfate is a sclerosing (skler-OH-sing) agent. It works by increasing the formation of blood clots and scar tissue inside certain types of veins. This helps decrease dilation of enlarged veins.

Sodium tetradecyl sulfate is used to treat small uncomplicated varicose veins in the legs.

Sodium tetradecyl sulfate is not a cure for varicose veins and the effects of this medication may not be permanent.

Sodium tetradecyl sulfate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sotradecol (sodium tetradecyl sulfate)?

You should not be treated with sodium tetradecyl sulfate if you are allergic to it, if you are bedridden due to serious illness, or if you have a serious blood clot or a clotting disorder, allergies, cancer, severe blood infection, or any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, a blood cell disorder, or skin disease.

Sodium tetradecyl sulfate should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects. Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected. Call your doctor at once if you have a serious side effect such as pain or swelling in one or both legs, chest pain, sudden cough, wheezing, rapid breathing, fast heart rate, or skin changes where the medicine was injected.

What should I discuss with my health care provider before receiving Sotradecol (sodium tetradecyl sulfate)?

You should not receive sodium tetradecyl sulfate if you are allergic to it, or if you have:

• a blood clot disorder such as deep vein thrombosis (DVT) or thrombophlebitis (swelling of a vein caused by a blood clot);

• Buerger’s disease (a blood clotting disorder affecting the arms and legs);

• allergies;

• cancer;

• a severe infection of your blood (sepsis);

• any untreated or uncontrolled disease such as diabetes, overactive thyroid, tuberculosis, asthma, blood cell disorder, or skin disease; or

• if you are bed-ridden due to severe illness.

Sodium tetradecyl sulfate should not be used to treat varicose veins that are caused by a tumor in your stomach or pelvis area, unless the tumor has been surgically removed.

FDA pregnancy category C. It is not known whether sodium tetradecyl sulfate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether sodium tetradecyl sulfate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is sodium tetradecyl sulfate given?

Sodium tetradecyl sulfate is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

You will be watched closely for several hours after your injection, to make sure this medication is not causing harmful effects.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

You may need to wear compression stockings for several days or weeks after your treatment. Carefully follow your doctor’s instructions about caring for yourself after receiving this medication.

What happens if I miss a dose?

Since sodium tetradecyl sulfate is given as needed by a healthcare professional, you are not likely to miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose is not likely to occur in a medical setting.

What should I avoid while receiving Sotradecol (sodium tetradecyl sulfate)?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Sotradecol (sodium tetradecyl sulfate) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; sneezing, runny nose, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• pain or swelling in one or both legs;

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or

• pain, itching, peeling, skin sores, or skin changes where the medicine was injected.

Less serious side effects may include:

• mild headache;

• nausea, vomiting; or

• discolored skin along the treated vein (may be permanent).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sotradecol (sodium tetradecyl sulfate)?

Tell your doctor if you are taking birth control pills or other medications that stop or prevent ovulation (ovaries releasing eggs).

There may be other drugs that can interact with sodium tetradecyl sulfate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about sodium tetradecyl sulfate.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.01. Revision Date: 05/14/2010 9:28:33 AM.

Generic Name: sotalol AF (SO tuh lol AF)
Brand Names: Betapace AF, Sotalol Hydrochloride AF

What is sotalol AF?

Sotalol AF is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol AF is used to help keep the heart beating normally in people with certain heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter.

Another form of this medicine, called sotalol, is used to treat heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol AF may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about sotalol AF?

You should not use this medication if you are allergic to sotalol AF, or if you have asthma, certain serious heart conditions, a history of “Long QT syndrome,” severe kidney disease, low levels of potassium in your blood, or uncontrolled congestive heart failure.

Before taking sotalol AF, tell your doctor if you have breathing problems, a history of heart disease or congestive heart failure, diabetes, kidney disease, a thyroid disorder, an electrolyte imbalance, or if you have recently had a heart attack.

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

You will receive your first few doses of sotalol AF in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

What should I discuss with my healthcare provider before taking sotalol AF?

Do not use this medication if you are allergic to sotalol AF, or if you have:

• asthma;

• certain heart conditions, especially “AV block” or “sick sinus syndrome” (unless you have a pacemaker);

• a history of “Long QT syndrome”;

• severe kidney disease;

• low levels of potassium in your blood (hypokalemia); or

• severe or uncontrolled congestive heart failure.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take sotalol AF:

• breathing problems such as bronchitis or emphysema;

• a history of heart disease or congestive heart failure;

• diabetes;

• kidney disease;

• a thyroid disorder;

• an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

• if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol AF can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sotalol AF?

You will receive your first few doses of sotalol AF in a hospital setting where your heart can be monitored, in case the medication causes serious side effects.

Sotalol AF comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take sotalol AF exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol AF at the same time every day.

Do not skip doses or stop taking sotalol AF without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely. Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medication, which can lead to severely low blood pressure or a serious electrolyte imbalance.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any follow-up visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol AF.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using sotalol AF. You may need to stop using the medicine for a short time.

Store sotalol AF at room temperature away from moisture and heat.

See also: Sotalol AF dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Call your doctor if you miss more than two doses of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, hunger, weakness, confusion, sweating, slow or fast heartbeats, chest pain, feeling short of breath, fainting, and seizure (convulsions).

What should I avoid while taking sotalol AF?

Do not take an antacid within 2 hours before or after taking sotalol AF. Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol AF.

Sotalol AF side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat, chest pain, shortness of breath;

• feeling light-headed, fainting;

• slow heartbeat;

• unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Less serious side effects may include:

• mild diarrhea, nausea, vomiting;

• headache;

• sleep problems (insomnia); or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sotalol AF Dosing Information

Usual Adult Dose for Atrial Fibrillation:

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Atrial Flutter:

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Ventricular Arrhythmia:

Oral (Betapace):

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 intravenous sotalol 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.

Usual Pediatric Dose for Atrial Fibrillation:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally adminis
tered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

Usual Pediatric Dose for Atrial Flutter:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

Usual Pediatric Dose for Ventricular Arrhythmia:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

What other drugs will affect sotalol AF?

Tell your doctor about all other medications you use, especially:

• clonidine (Catapres);

• digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

• reserpine;

• a diuretic (water pill);

• drugs that can affect heart rhythm, such as cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

• any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Cardioquin, Quinaglute), sotalol (Betapace);

• antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

• a phenothiazine such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), and others;

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

• a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

• a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

• medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair).

This list is not complete and there may be other drugs that can interact with sotalol AF. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about sotalol AF.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 2.01. Revision Date: 09/24/2009 11:03:57 AM.

Pronunciation: (SOE-ta-lol HYE-droe-KLOR-ide)
Class: Beta-adrenergic blocking agent

Trade Names:
Betapace
- Tablets 80 mg
- Tablets 120 mg
- Tablets 160 mg
- Tablets 240 mg

Trade Names:
Betapace AF
- Tablets 80 mg
- Tablets 120 mg
- Tablets 160 mg

Trade Names:
Sotalol Hydrochloride
- Injection, solution, concentrate 15 mg/mL

Apo-Sotalol (Canada)
CO Sotalol (Canada)
Gen-Sotalol (Canada)
PMS-Sotalol (Canada)
ratio-Sotalol (Canada)
Sandoz Sotalol (Canada)

Pharmacology

Blocks beta receptors, which primarily affect heart (slows rate), lungs (reduces function), and vascular musculature (decreases BP), and prolongs the duration of cardiac action potential.

Pharmacokinetics

Absorption

Oral bioavailability is 90% to 100% and T _max is 2.5 to 4 h. Absorption was reduced approximately 20% compared to fasting when administered with a standard meal. Steady state is reached after 2 to 3 days (oral) and 1 to 2 days (IV).

Distribution

Does not bind to plasma proteins and crosses the blood-brain barrier poorly.

Metabolism

Sotalol is not metabolized.

Elimination

Half-life is 12 h (oral) and 9.5 h (IV). It is excreted unchanged predominantly via the kidney.

Special Populations

Renal Function Impairment

Lower doses are necessary in renal function impairment.

Hepatic Function Impairment

Patients with hepatic function impairment show no alteration in sotalol Cl.

Indications and Usage

Betapace

Management or prevention of life-threatening ventricular arrhythmias.

Betapace AF

Maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/atrial flutter (AFIB/AFL).

Sotalol IV

Maintenance of normal sinus rhythm in patients with symptomatic AFIB/AFL; treatment of documented life-threatening ventricular arrhythmias.

Contraindications

Betapace

Hypersensitivity to beta-blockers; greater than first-degree heart block; CHF unless secondary to tachyarrhythmia treatable with beta-blockers; overt cardiac failure; sinus bradycardia; cardiogenic shock; bronchial asthma or bronchospasm, including severe COPD; congenital or acquired long QT syndromes.

Betapace AF , sotalol IV

Sinus bradycardia (less than 50 bpm during waking hours); sick sinus syndrome or second- and third-degree AV block (unless a functioning pacemaker is present); congenital or acquired QT syndromes; baseline QT interval greater than 450 msec; cardiogenic shock; uncontrolled heart failure; hypokalemia (less than 4 mEq/L); CrCl less than 40 mL/min; bronchial asthma; previous evidence of hypersensitivity to sotalol.

Dosage and Administration

Do not substitute Betapace for Betapace AF because of significant differences in labeling (eg, patient package insert, dosing administration, safety information).

Betapace
Adults

PO 80 mg twice daily; may increase up to 320 mg/day in 2 or 3 divided doses. Patients with a history of symptomatic AFIB/AFL currently receiving Betapace should be transferred to Betapace AF because of the significant differences in labeling.

Betapace AF
Adults

PO Initiate therapy at 80 mg twice daily if CrCl is greater than 60 mL/min, and 80 mg once daily if the CrCl is 40 to 60 mL/min. Begin continuous ECG monitoring with QT interval measurements 2 to 4 h after each dose. If the 80 mg dose level is tolerated and QT interval remains less than 500 msec after at least 3 days, the patient may be discharged. Alternatively, during hospitalization, if 80 mg level does not reduce the frequency of relapse of AFIB/AFL and is tolerated without excessive QT interval prolongation (ie, greater than 520 msec), after following the patient for 3 days, the dose level may be increased to 120 mg (once or twice daily depending on CrCl). The max recommended dosage in patients with CrCl greater than 60 mL/min is 160 mg twice daily.

Children 2 years of age and older

PO 30 mg/m ² 3 times a day initially (approximately equivalent to the initial 160 mg total oral daily dose in adults). Titrate to a maximum of 60 mg/m ² (approximately equivalent to the 360 mg total daily dose for adults) based on clinical response, heart rate, and QTc. Allow at least 36 h between dose increases.

Children 2 years of age and younger

PO Reduce the dosage provided above by a factor that depends heavily upon age. Please refer to the graph in the Betapace package insert. For example, for a child 20 mo of age, the initial starting dose would be 30 mg/m ² × 0.97 = 29.1 mg/m ² , administered orally 3 times daily.

Sotalol Injection
AFIB/AFL Adults

IV 75 mg infused over 5 h twice daily if CrCl is greater than 60 mL/min or once daily if CrCl is 40 to 60 mL/min, initially. If after at least 3 days the 75 mg dose does not reduce the frequency of relapses of symptomatic AFIB/AFL and is tolerated without excessive (to greater than 500 msec) QTc prolongation, increase the dosage to 112.5 mg once or twice daily depending on the CrCl. An additional increase to 150 mg once or twice daily depending on the CrCl may be made after at least 3 days if necessary and if previous dose is tolerated without excessive QTc prolongation (greater than 520 msec).

Ventricular Arrhythmias Adults

IV 75 mg infused over 5 h twice daily if CrCl is greater than 60 mL/min or once daily if CrCl is 40 to 60 mL/min, initially. If after at least 3 days, the 75 mg dose does not reduce the frequency of relapses of symptomatic AFIB/AFL and is tolerated without excessive (to greater than 500 msec) QTc prolongation, increase the dosage to 112.5 mg once or twice daily depending on the CrCl. Additional increases in increments of 75 mg/day may be made every 3 days if necessary. Dosages as high as 225 to 300 mg once or twice daily depending on CrCl have been used in patients with refractory life-threatening arrhythmias.

Conversion From Oral to IV Sotalol

The 80 mg oral dose is equivalent to 75 mg of sotalol IV. 120 mg orally is equivalent to 112.5 mg of sotalol IV. 160 mg orally is equivalent to 150 mg of sotalol IV.

General Advice

• Therapy with Betapace AF or sotalol injection must be initiated and, if necessary, titrated in a setting that provides continuous ECG monitoring and personnel trained in the management of serious ventricular arrhythmias. Monitor patients in this way for a minimum of 3 days on the maintenance dose and do not discharge within 12 h of electrical or pharmacological conversion to normal sinus rhythm.
• Sotalol injection is for IV infusion only; not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Infuse sotalol IV over 5 h.
• Dilute solution for injection prior to administration following manufacturer’s guidelines using sodium chloride 0.9% injection, dextrose 5% injection, or Ringer’s lactate injection.

Storage/Stability

Store at 59° to 86°F. Protect from light.

Drug Interactions

Alpha-1 adrenergic blocking agents (eg, prazosin)

The severity and duration of hypotension following the first dose of an alpha-1 adrenergic blocker may be enhanced in patients receiving sotalol. Patients already receiving an alpha-1 adrenergic blocker may not be affected by addition of sotalol. Use with caution, closely monitoring the clinical response of the patient.

Aluminum salts

Bioavailability of sotalol may be decreased, reducing the pharmacologic effects. Administration of aluminum salts at least 2 h after sotalol may minimize this interaction.

Anticholinesterases (eg, neostigmine)

Severe or prolonged bradycardia may occur in patients receiving sotalol. Use with caution.

Beta-2 receptor stimulants (eg, albuterol, isoproterenol, terbutaline)

Beta-2 receptor stimulant efficacy may be reduced. Increased dosage may be needed when sotalol is coadministered.

Calcium channel blockers (eg, diltiazem, verapamil)

Increased risk of hypotension; possible increased effect on AV conduction or ventricular function. Use with caution. Monitor the clinical response of the patient.

Clonidine

May enhance or reverse antihypertensive effects; may increase clonidine rebound hypertension. Use with caution.

Cocaine

Pharmacologic and cardiotoxic effects of cocaine may be increased by sotalol. Avoid coadministration in patients with cocaine-induced myocardial ischemia or infarction.

Digoxin

Proarrhythmic events are more common when digoxin and sotalol are coadministered. Use with caution.

Drugs that prolong the QT interval (eg, antiarrhythmic agents [eg, amiodarone, disopyramide, dofetilide, procainamide, quinidine], arsenic trioxide, chloroquine, chlorpromazine, cisapride, dolasetron, droperidol, fluconazole, halofantrine, haloperidol, macrolide and related antibiotics [eg, clarithromycin, telithromycin], maprotiline, mefloquine, mesoridazine, methadone, nilotinib, paliperidone, pentamidine, perflutren, phosphodiesterase type 5 inhibitors [eg, sildenafil], pimozide, propafenone, quinolone antibiotics [ie, gatifloxacin, moxifloxacin], tacrolimus, tetrabenazine, thioridazine, tricyclic antidepressants [eg, doxepin, nortriptyline], tyrosine kinase receptor antagonists [eg, lapatinib], ziprasidone

The risk of CV toxicity, including prolongation of the QT interval and fatal cardiac arrhythmias (torsades de pointes), may be increased. Coadministration is not recommended.

Epinephrine

Increased BP and bradycardia may occur as a result of unopposed alpha-adrenergic effects of epinephrine. Avoid coadministration.

Guanethidine, reserpine

Increased risk of hypotension or bradycardia. Monitor the clinical response of the patient.

Insulin, meglitinide antidiabetic agents (eg, repaglinide), oral sulfonylurea hypoglycemic agents (eg, glyburide, tolbutamide)

Hyperglycemia; symptoms of hypoglycemia may be masked. Antidiabetic dosage may require adjustments.

NSAIDs (ie, ibuprofen, indomethacin, naproxen, piroxicam)

Some agents may impair antihypertensive effect. Monitor BP and adjust the sotalol dose as needed.

Theophyllines (eg, aminophylline, theophylline)

The bronchodilating effect of theophyllines may be impaired. Avoid coadministration.

Laboratory Test Interactions

May interfere with glucose or insulin tolerance tests; may result in falsely elevated urinary levels of metanephrine.

Adverse Reactions

Cardiovascular

Bradycardia, chest pain (16%); palpitation (14%); subjective rhythm disturbance (10%); ECG abnormal (7%); hypotension (6%); heart failure, nonanginal cardiac chest pain, proarrhythmia, syncope (5%); presyncope, torsade de pointes (4%); automatic implantable cardiac defibrillator discharge, CV disorder, vasodilation (3%); angina pectoris, atrial rhythm disturbance, hypertension (2%); worsened ventricular tachycardia (1%).

CNS

Dizziness, fatigue (20%); asthenia (13%); headache, light-headedness (12%); sleep problem (8%); perspiration (6%); weakness (5%); altered consciousness, anxiety, depression, insomnia, paresthesia (4%); mood change (3%); stroke (1%); paralysis (postmarketing).

Dermatologic

Rash (5%).

EENT

Vision problem (5%).

GI

Nausea/vomiting (10%); diarrhea (7%); dyspepsia (6%); abdominal pain (4%); abdominal distension, appetite disorder, colon problem, dyspepsia/heartburn (3%); flatulence (2%).

Genitourinary

GU disorder, sexual dysfunction (3%).

Hematologic

Eosinophilia, leukopenia, thrombocytopenia (postmarketing).

Hepatic

Elevated serum liver enzymes.

Metabolic-Nutritional

Edema (8%); abnormal lab (4%); weight change (2%); elevated blood glucose levels; hyperlipidemia (postmarketing).

Musculoskeletal

Extremity pain (7%); pain, musculoskeletal (4%); back pain, chest pain, (3%).

Respiratory

Dyspnea (21%); pulmonary problem (8%); upper respiratory tract problem (5%); cough, tracheobronchitis, upper respiratory tract infection (3%); asthma (2%); pulmonary edema (postmarketing).

Miscellaneous

Hyperhidrosis (5%); fever, infection (4%); cold sensation, localized pain (3%); bleeding, influenza (2%).

Precautions

Warnings Life-threatening proarrhythmia To minimize risk of induced arrhythmia, initiate or reinitiate therapy for at least 3 days in facility that can provide cardiac resuscitation and ECG monitoring. Sotalol can cause life-threatening ventricular tachycardia associated with QT-interval prolongation. Do not initiate sotalol therapy if the baseline QTc is longer than 450 msec. If the QTc interval prolongs to 500 msec or greater, reduce the dose, prolong the duration of IV infusion, or discontinue the medicine. Do not substitute Betapace for Betapace AF . Betapace does not have an atrial fibrillation indication or package insert information for patient.

Monitor Perform a baseline ECG to determine QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy. Measure serum creatinine and calculate an estimated CrCl to establish the appropriate dosing interval for sotalol. During initiation and titration, monitor QT interval after the completion of each infusion. Monitor heart rate frequently and monitor hemodynamics in patients with marginal cardiac compensation as deterioration in cardiac performance may occur.

Pregnancy

Category B . Category D if used in the second or third trimester (per Briggs’ Drugs in Pregnancy and Lactation ).

Lactation

Excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

May occur in patients withdrawn from beta-blockers. Patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge and may be unresponsive to usual doses of epinephrine.

Renal Function

Alteration of dosage interval and reduced daily dose are advised.

Abrupt withdrawal

Has been associated with adverse effects, including exacerbation of angina pectoris, arrhythmias, and MI; gradually decrease dose over 1 to 2 wk. Carefully monitor patients, especially those with ischemic heart disease, and consider temporary use of an alternative beta-blocker if appropriate.

Anesthesia

Severe hypotension and difficulty in restoring and maintaining cardiac rhythm after anesthesia have been reported.

Bradycardia

May occur and increase the risk of torsades de pointes.

CHF

New or worsening heart failure has occurred. Administer cautiously in patients with CHF controlled by digitalis and diuretics.

Diabetic patients

Drug may mask signs and symptoms of hypoglycemia (eg, tachycardia, BP changes). Drug may potentiate insulin-induced hypoglycemia.

Electrolyte disturbances

Do not use in patients with uncorrected hypokalemia or hypomagnesemia. Give special attention to electrolyte and acid base balance in patients experiencing severe or prolonged diarrhea.

Hypotension

Significant reductions in both systolic and diastolic BP may occur.

Nonallergic bronchospasm

Give drug with caution in patients with bronchospastic disease.

Thyrotoxicosis

May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm.

Overdosage

Symptoms

Bradycardia, bronchospasm, cardiac asystole, CHF, hypoglycemia, hypotension, premature ventricular complexes, prolongation of QT interval, torsades de pointes, ventricular tachycardia.

Patient Information

• Explain importance of not discontinuing drug suddenly, and advise that dosage will be decreased over 1 to 2 wk.
• Explain that drug may mask signs and symptoms of hypoglycemia.
• Teach patient to take pulse daily and to notify health care provider if pulse is less than 60.
• Tell patient to call health care provider if adverse reaction occurs.
• Instruct patients to report syncopal events or new presyncopal symptoms.

Copyright © 2009 Wolters Kluwer Health.

Generic Name: Acitretin with Moisturizer (A-si-TRE-tin)
Brand Name: Soriatane CK

Soriatane CK is used for:

Treating severe psoriasis.

Soriatane CK is a kit that contains a vitamin A derivative (retinoid) and moisturizing foam. Exactly how the retinoid works is not known. The moisturizing foam relieves dry and chapped skin.

Do NOT use Soriatane CK if:

• you are allergic to any ingredient in Soriatane CK or to another retinoid (eg, tretinoin)
• you are pregnant, planning to become pregnant, or are breast-feeding
• you have severe liver or kidney problems
• you have persistent high blood lipid levels
• you are taking methotrexate, a tetracycline, or vitamin A

Contact your doctor or health care provider right away if any of these apply to you.

Before using Soriatane CK:

Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetes or high blood lipid levels, are very overweight, or have a family member with any of these problems
• if you have a history of liver or kidney problems, bone problems, pancreas problems (eg, pancreatitis), heart disease, or mental or mood problems (eg, depression, suicidal thoughts or actions)
• if you receive phototherapy or drink alcohol
• if you take St. John’s wort; it may decrease the effectiveness of hormonal contraceptives (eg, birth control pills)
• if you take a progestin-only birth control pill (mini-pill); your doctor may need to prescribe a different form of hormonal birth control

Some MEDICINES MAY INTERACT with Soriatane CK. Tell your health care provider if you are taking any of the following medicines.

• Certain medicines for diabetes (eg, glyburide) because the risk of low blood sugar may be increased
• Methotrexate or tetracyclines (eg, doxycycline) because liver damage or increased pressure in the brain may occur
• Vitamin A because it may increase the risk of Soriatane CK’s side effects
• Phenytoin because the risk of its side effects may be increased by Soriatane CK
• Certain hormonal contraceptives (eg, low-dose progestin-only birth control pill, mini-pill) because their effectiveness may be decreased by Soriatane CK

This may not be a complete list of all interactions that may occur. Ask your health care provider if Soriatane CK may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Soriatane CK:

Use Soriatane CK as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Soriatane CK comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Soriatane CK refilled.
• Take the capsule(s) by mouth with a meal at about the same time each day, or as directed by your doctor.
• To use the foam, shake well before each use. Point the canister down and dispense a small amount onto the affected area as needed. Gently message the area until the foam disappears. Repeat as needed.
• Continue to use Soriatane CK even if your condition does not improve right away. Your condition may become worse for a short time before it improves. It may take 2 to 3 months before you see the full benefits of Soriatane CK.
• If you miss a dose of Soriatane CK, you may take it later the same day. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Soriatane CK.

Important safety information:

• Soriatane CK may cause drowsiness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Soriatane CK with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Soriatane CK may cause decreased night vision. Use caution or avoid driving at night if you experience this effect.
• Do not drink alcohol while you are taking Soriatane CK without first checking with your doctor.
• Your condition may return after you stop treatment with Soriatane CK. Check with your doctor if this occurs. Do not use any leftover medicine to treat your skin condition.
• Soriatane CK is similar to vitamin A. Before you start any new medicine, check the label to see if it has vitamin A in it too. Do not take other medicines that contain vitamin A without checking with your doctor.
• Soriatane CK may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Soriatane CK. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Dental problems (eg, mouth sores, gum bleeding) may occur while you take Soriatane CK. Contact your doctor or dentist if these problems persist or become bothersome.
• If you wear contact lenses, you may notice increased irritation with them while you are taking Soriatane CK. If these effects continue, check with your doctor.
• The foam is for external use only. Do not get it into your eyes, nose, mouth, lips, or near your genital area. If you get the foam in one of these areas, rinse the area right away with water.
• The foam is flammable. Do not store or use near and open flame, or while you are smoking.
• Women who are able to become pregnant must use 2 effective forms of birth control for at least 1 month before they start Soriatane CK, while they take it, and for at least 3 years after they stop treatment.
• Diabetes patients – Soriatane CK may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including monthly pregnancy tests, liver function tests, x-rays, and lipid tests, may be performed while you use Soriatane CK. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Soriatane CK with caution in the ELDERLY; they may be more sensitive to its effects.
• Soriatane CK is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Soriatane CK if you are pregnant. If you think that you may be pregnant, contact your doctor right away. Women of childbearing age should either abstain from sexual intercourse or use 2 effective methods of birth control for at least 1 month before, while taking, and for 3 years after taking Soriatane CK. Do not breast-feed while you are using Soriatane CK and for at least 3 years after stopping treatment.

Possible side effects of Soriatane CK:

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dry mouth, lips, or nose; dry or irritated eyes; hair loss; runny nose; thinning of the eyebrows or eyelashes; thinning, peeling, or scaling of the skin; weak nails.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or joint pain or stiffness; blurred vision or other vision changes; bone pain; calf or leg pain or swelling; chest pain; dark urine; eye pain; loss of appetite; mental or mood changes (eg, aggressiveness, depression); muscle pain, stiffness, or weakness; numbness or tingling of the hands or feet; one-sided weakness; pale stools; red, blistered, swollen skin; severe dizziness; severe or persistent headache; severe or persistent stomach pain, nausea, or vomiting; shortness of breath; signs of high blood sugar (eg, frequent hunger, thirst, or urination); slurred speech; suicidal thoughts or actions; vaginal itching, odor, or discharge; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include severe or persistent headache or dizziness.

Proper storage of Soriatane CK:

Store Soriatane CK at room temperature, between 59 and 77 degrees F (15 and 25 degrees C) in a tightly closed container. Avoid temperatures above 120 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Soriatane CK out of the reach of children and away from pets.

General information:

• If you have any questions about Soriatane CK, please talk with your doctor, pharmacist, or other health care provider.
• Soriatane CK is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Soriatane CK. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: sotalol (SOE ta lol)
Brand Names: Betapace, Sorine

What is Sorine (sotalol)?

Sotalol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation.

Another form of this medicine, called Sotalol AF, is used to treat heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Sorine (sotalol)?

You will receive your first few doses of sotalol in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, you may need to temporarily stop using sotalol. Be sure the surgeon knows ahead of time that you are using sotalol.

What should I discuss with my healthcare provider before taking Sorine (sotalol)?

Do not use this medication if you are allergic to sotalol, or if you have:

• asthma;

• certain heart conditions, especially “AV block” (unless you have a pacemaker);

• a history of “Long QT syndrome”; or

• severe or uncontrolled congestive heart failure.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take sotalol:

• breathing problems such as bronchitis or emphysema;

• a history of heart disease or congestive heart failure;

• diabetes;

• kidney disease;

• a thyroid disorder;

• an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

• if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Sorine (sotalol)?

You will receive your first few doses of sotalol in a hospital setting where your heart can be monitored in case the medication causes serious side effects.

Take sotalol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol at the same time every day.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

Tell your doctor if you have an illness that involves diarrhea or vomiting lasting more than a few hours. Prolonged diarrhea or vomiting can lower your potassium levels, making it dangerous for you to use sotalol.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol.

If you need to have any type of surgery, tell the surgeon that you are using sotalol. You may need to briefly stop using sotalol before having surgery.

Store sotalol at room temperature away from moisture and heat.

See also: Sorine dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow or fast heartbeats, shortness of breath, chest pain, swelling, hunger, weakness, confusion, sweating, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while taking Sorine (sotalol)?

Do not take an antacid within 2 hours before or after taking sotalol. Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol.

Sorine (sotalol) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat, chest pain, shortness of breath;

• feeling light-headed, fainting;

• slow heartbeat;

• unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Less serious side effects may include:

• mild diarrhea, nausea, vomiting;

• headache;

• sleep problems (insomnia); or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Sorine (sotalol)?

Tell your doctor about all other medications you use, especially:

• clonidine (Catapres);

• digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

• reserpine;

• a diuretic (water pill);

• drugs that can affect heart rhythm, such as cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

• any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Quinaglute, Quinidex, Quin-Release);

• antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

• a phenothiazine such as chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine), trifluoperazine (Stelazine);

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

• a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

• a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

• medicine for asthma other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Elixophyllin, Theo-24, Uniphyl).

This list is not complete and there may be other drugs that can interact with sotalol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about sotalol.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.01. Revision Date: 12/04/2009 10:18:16 AM.

Generic Name: sotalol (SOE ta lol)
Brand Names: Betapace, Sorine

What is sotalol?

Sotalol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Sotalol is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart). Sotalol is used in people with ventricular tachycardia or ventricular fibrillation.

Another form of this medicine, called Sotalol AF, is used to treat heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart). Sotalol AF is used in people with atrial fibrillation or atrial flutter. Sotalol (Betapace and Sorine) is not used for the same conditions that sotalol AF (Betapace AF) is used for.

Sotalol may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about sotalol?

You will receive your first few doses of sotalol in a hospital setting where your heart rhythm can be monitored, in case the medication causes serious side effects.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

If you need to have any type of surgery, you may need to temporarily stop using sotalol. Be sure the surgeon knows ahead of time that you are using sotalol.

What should I discuss with my healthcare provider before taking sotalol?

Do not use this medication if you are allergic to sotalol, or if you have:

• asthma;

• certain heart conditions, especially “AV block” (unless you have a pacemaker);

• a history of “Long QT syndrome”; or

• severe or uncontrolled congestive heart failure.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take sotalol:

• breathing problems such as bronchitis or emphysema;

• a history of heart disease or congestive heart failure;

• diabetes;

• kidney disease;

• a thyroid disorder;

• an electrolyte imbalance such as low levels of potassium or magnesium in your blood; or

• if you have recently had a heart attack.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Sotalol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take sotalol?

You will receive your first few doses of sotalol in a hospital setting where your heart can be monitored in case the medication causes serious side effects.

Take sotalol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

If there are any changes in the brand or strength of sotalol you use, your dosage needs may change. Betapace and Sorine are not used for the same conditions that Betapace AF is used for. Always check your medicine when it is refilled to make sure you have received the correct brand and type as prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine given to you at the pharmacy.

Take this medication with a full glass of water.

Take sotalol at the same time every day.

Do not skip doses or stop taking sotalol without first talking to your doctor. Stopping suddenly may make your condition worse. You may need to use less and less before you stop the medication completely.

Tell your doctor if you have an illness that involves diarrhea or vomiting lasting more than a few hours. Prolonged diarrhea or vomiting can lower your potassium levels, making it dangerous for you to use sotalol.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Your heart and kidney function will also need to be tested. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using sotalol.

If you need to have any type of surgery, tell the surgeon that you are using sotalol. You may need to briefly stop using sotalol before having surgery.

Store sotalol at room temperature away from moisture and heat.

See also: Sotalol dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include slow or fast heartbeats, shortness of breath, chest pain, swelling, hunger, weakness, confusion, sweating, feeling light-headed, fainting, or seizure (convulsions).

What should I avoid while taking sotalol?

Do not take an antacid within 2 hours before or after taking sotalol. Avoid using antacids without your doctor’s advice. Use only the specific type of antacid your doctor recommends. Antacids contain different medicines and some types can make it harder for your body to absorb sotalol.

Sotalol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• fast or pounding heartbeat, chest pain, shortness of breath;

• feeling light-headed, fainting;

• slow heartbeat;

• unusual sweating, increased thirst; or

• swelling, rapid weight gain.

Less serious side effects may include:

• mild diarrhea, nausea, vomiting;

• headache;

• sleep problems (insomnia); or

• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sotalol Dosing Information

Usual Adult Dose for Atrial Fibrillation:

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Atrial Flutter:

Oral (Betapace AF):

Initial dose: 80 mg orally twice a day. Continuous ECG monitoring with QT interval measurements should begin after the first dose and every 2 to 4 hours after each additional dose.

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 the creatinine clearance) 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 the creatinine clearance).

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 the creatinine clearance), 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 of sotalol 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 intravenous sotalol 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.

Usual Adult Dose for Ventricular Arrhythmia:

Oral (Betapace):

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 intravenous sotalol 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.

Usual Pediatric Dose for Atrial Fibrillation:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally adminis
tered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

Usual Pediatric Dose for Atrial Flutter:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

Usual Pediatric Dose for Ventricular Arrhythmia:

2 years and older:

Initial: 30 mg/m2 orally three times a day (90 mg/m2/day) is approximately equivalent to the initial 160 mg total daily dose for adults.

Maintenance: The initial dose can be titrated to a maximum of 60 mg/m2 (approximately equivalent to the 360 mg total daily dose for adults) according to clinical response, heart rate, and QTc. Dose increments can be made at least 36 hours apart in order to attain steady-state plasma concentrations in patients with age-adjusted normal renal function.

2 years or younger:

The dosage recommended for children less than two years of age should be reduced by a factor that depends heavily upon age, determined using the manufacturer’s logarithmic scale. For example, a child 20 months of age would receive the dosing suggested for children with normal renal function aged 2 years or greater multiplied by about 0.97; therefore, the initial starting dose would be 29.1 mg/m2 orally administered three times daily. Likewise, the initial starting dose for children 1 month of age should be multiplied by 0.68; therefore, the initial starting dose would be 20 mg/m2 orally administered three times daily. The initial starting dose for children 1 week of age should be multiplied by 0.3; therefore, the starting dose would be 9 mg/m2 orally administered three times daily. Refer to the manufacturer’s labeling for exact dosing.

Time to steady-state increases in patients less than 2 years of age (as the half-life of sotalol decreases with decreasing age). Therefore, the time to steady-state in neonates may be as long as a week or longer.

Parenteral sotalol has not been studied in pediatric patients (less than 18 years of age).

What other drugs will affect sotalol?

Tell your doctor about all other medications you use, especially:

• clonidine (Catapres);

• digoxin (digitalis, Digitek, Lanoxicaps, Lanoxin);

• reserpine;

• a diuretic (water pill);

• drugs that can affect heart rhythm, such as cisapride (Propulsid), droperidol (Inapsine), methadone (Methadose), pentamidine (NebuPent, Pentam);

• any other heart rhythm medications, especially amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procan), quinidine (Quinaglute, Quinidex, Quin-Release);

• antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), telithromycin (Ketek);

• medicines to treat psychiatric disorder, such as pimozide (Orap), haloperidol (Haldol), thioridazine (Mellaril);

• a phenothiazine such as chlorpromazine (Thorazine), thioridazine (Mellaril), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine), trifluoperazine (Stelazine);

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others;

• a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), metformin (Glucophage);

• a calcium channel blocker such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or

• medicine for asthma other breathing disorders, such as albuterol (Ventolin, Proventil), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Elixophyllin, Theo-24, Uniphyl).

This list is not complete and there may be other drugs that can interact with sotalol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about sotalol.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.01. Revision Date: 12/04/2009 10:18:16 AM.

SOE-ta-lol

Commonly used brand name(s):

In the U.S.

• Betapace
• Betapace AF
• Sorine

Available Dosage Forms:

• Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Beta-Adrenergic Blocker, Nonselective

Uses For sotalol

Sotalol is used to control rapid heartbeats and abnormal heart rhythms .

sotalol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and at a regular rhythm .

sotalol is available only with your doctor’s prescription .

Before Using sotalol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For sotalol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sotalol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sotalol in the pediatric population. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of sotalol in geriatric patients .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using sotalol with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Grepafloxacin
• Levomethadyl
• Mesoridazine
• Pimozide
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using sotalol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acecainide
• Acetazolamide
• Ajmaline
• Albuterol
• Amiloride
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Aprindine
• Arformoterol
• Arsenic Trioxide
• Asenapine
• Astemizole
• Azimilide
• Azithromycin
• Azosemide
• Bambuterol
• Bemetizide
• Bendroflumethiazide
• Benzthiazide
• Bitolterol
• Bretylium
• Broxaterol
• Bumetanide
• Canrenoate
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Chlorthalidone
• Ciprofloxacin
• Clarithromycin
• Clenbuterol
• Clonidine
• Clopamide
• Colterol
• Cyclothiazide
• Desipramine
• Dibenzepin
• Diltiazem
• Disopyramide
• Dofetilide
• Dolasetron
• Doxepin
• Dronedarone
• Droperidol
• Enflurane
• Epinephrine
• Erythromycin
• Ethacrynic Acid
• Etozolin
• Fenoldopam
• Fenoterol
• Fenquizone
• Fentanyl
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Halofantrine
• Haloperidol
• Halothane
• Hexoprenaline
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroquinidine
• Ibutilide
• Iloperidone
• Imipramine
• Indapamide
• Isoetharine
• Isoflurane
• Isradipine
• Itraconazole
• Ketoconazole
• Lapatinib
• Levalbuterol
• Levofloxacin
• Lidocaine
• Lidoflazine
• Lorcainide
• Lumefantrine
• Mannitol
• Mefloquine
• Metaproterenol
• Methadone
• Metolazone
• Moxifloxacin
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Paliperidone
• Pazopanib
• Pentamidine
• Pirbuterol
• Piretanide
• Pirmenol
• Polythiazide
• Prajmaline
• Prilocaine
• Probucol
• Procainamide
• Procaterol
• Propafenone
• Quetiapine
• Quinethazone
• Quinidine
• Ranolazine
• Reproterol
• Rimiterol
• Risperidone
• Ritodrine
• Salmeterol
• Sematilide
• Sertindole
• Sotalol
• Spiramycin
• Spironolactone
• Sulfamethoxazole
• Sultopride
• Sunitinib
• Tedisamil
• Telavancin
• Telithromycin
• Terbutaline
• Tetrabenazine
• Ticrynafen
• Torsemide
• Tretoquinol
• Triamterene
• Trichlormethiazide
• Trimethoprim
• Trimipramine
• Tulobuterol
• Vardenafil
• Vasopressin
• Verapamil
• Voriconazole
• Xipamide
• Zolmitriptan
• Zotepine

Using sotalol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abarelix
• Acarbose
• Acetohexamide
• Alfuzosin
• Amlodipine
• Arbutamine
• Benfluorex
• Bunazosin
• Chlorpropamide
• Digoxin
• Doxazosin
• Felodipine
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glyburide
• Guar Gum
• Insulin
• Insulin Aspart, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Lacidipine
• Lercanidipine
• Manidipine
• Metformin
• Methyldopa
• Mibefradil
• Miglitol
• Moxisylyte
• Nicardipine
• Nifedipine
• Nilvadipine
• Nimodipine
• Nisoldipine
• Nitrendipine
• Phenoxybenzamine
• Phentolamine
• Pranidipine
• Prazosin
• Repaglinide
• St John’s Wort
• Tamsulosin
• Terazosin
• Tolazamide
• Tolbutamide
• Trimazosin
• Troglitazone
• Urapidil

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of sotalol. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma or
• Bradycardia (slow heartbeat) or
• Heart block or
• Heart failure or
• Long QT syndrome (heart rhythm problem)—Should not use in patients with these conditions .

• Diabetes or
• Hyperthyroidism (overactive thyroid) or
• Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Lung disease (e.g., bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

• Sick sinus syndrome (heart rhythm problem)—Use with caution. May make this condition worse .

Proper Use of sotalol

For the first three days, you will receive sotalol in a hospital where your heart rhythm can be monitored .

Do not interrupt or stop taking sotalol without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

Dosing

The dose of sotalol will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of sotalol. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For abnormal heart rhythms:
    • Adults—At first, 80 milligrams (mg) two times a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor .

Missed 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 go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using sotalol

It is very important that your doctor check your progress at regular visits to make sure sotalol is working properly and to check for unwanted effects .

Sotalol may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

sotalol may cause changes in your blood sugar levels. Also, sotalol may cover up signs of low blood sugar, such as a rapid pulse rate. Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using sotalol. You may need to stop using sotalol several days before having surgery or medical tests .

sotalol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Blurred vision
• chest pain or discomfort
• confusion
• diarrhea
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• lightheadedness, dizziness, or fainting
• nausea and vomiting
• shortness of breath
• sweating
• swelling of face, fingers, feet, or lower legs
• tightness in chest
• unusual tiredness or weakness
• wheezing

Less common

• Abdominal pain or swelling
• back pain
• black, tarry stools
• blood in eyes
• blood in urine
• body aches or pain
• bruising or purple areas on skin
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• change in consciousness
• cold hands and feet
• cough or hoarseness
• coughing up blood
• decreased alertness
• decreased urine output
• difficulty in speaking
• dilated neck veins
• double vision
• ear congestion
• extreme fatigue
• feeling of warmth or heat
• fever or chills
• flushing or redness of skin, especially on face and neck
• headache
• inability to move arms, legs, or facial muscles
• inability to speak
• irregular breathing
• joint pain or swelling
• loss of voice
• lower back or side pain
• nasal congestion
• nervousness
• noisy breathing
• nosebleeds
• painful, burning, or difficult urination
• pounding in the ears
• runny nose
• slow speech
• sneezing
• sore throat
• troubled breathing
• weight gain

Rare

• Bleeding gums
• fast breathing, sometimes with wheezing
• large amount of fat in the blood
• not able to move
• pinpoint red spots on skin
• sores, ulcers, or white spots on lips or in mouth
• swollen glands
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• cold sweats
• coma
• cool, pale skin
• depression
• increased hunger
• nightmares
• no heartbeat
• seizures
• shakiness
• slurred speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Acid or sour stomach
• belching
• difficulty in sleeping
• heartburn
• indigestion
• lack or loss of strength
• pain in arms or legs
• stomach discomfort or upset

Less common

• Abnormal ejaculation
• bloated
• decreased sexual performance or desire
• disturbed color perception
• double vision
• excess air or gas in stomach or intestines
• full feeling
• halos around lights
• loss of appetite
• loss of vision
• mood changes
• night blindness
• overbright appearance of lights
• passing gas
• skin rash
• tunnel vision
• weight changes

Rare

• Crying
• depersonalization
• difficulty in moving
• dysphoria
• euphoria
• feeling of constant movement of self or surroundings
• hair loss, thinning of hair
• increased sensitivity of skin to sunlight
• itching skin
• lack of coordination
• mental depression
• muscle aching or cramping
• muscle pains or stiffness
• paranoia
• quick to react or overreact emotionally
• rapidly changing moods
• redness or other discoloration of skin
• sensation of spinning
• severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Generic Name: acitretin (A si TRE tin)
Brand Names: Soriatane

What is Soriatane (acitretin)?

Acitretin is a retinoid, which is a form of vitamin A.

Acitretin is used to treat severe psoriasis in adults. It is usually given after other psoriasis medicines have been tried without successful treatment of symptoms.

Acitretin is not a cure for psoriasis, and you may relapse after you stop taking this medication.

Acitretin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Soriatane (acitretin)?

This medication can cause birth defects. Do not use if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. You must use 2 forms of birth control together starting at least 1 month before treatment with acitretin, and for at least 3 years after you stop taking this medication. For women taking acitretin: Before and during treatment, and for 3 years after treatment, you must have negative pregnancy tests at regular intervals to make sure you are not pregnant. No testing is needed if you have had a hysterectomy or have gone completely through menopause. Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). acitretin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol.

Acitretin is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.

What should I discuss with my healthcare provider before taking Soriatane (acitretin)?

Do not use this medication if you are allergic to acitretin or similar medications such as Accutane, Altinac, Avita, Renova, Retin-A, and others. Do not use acitretin if you are pregnant, or if you have:

• severe kidney disease;
• severe liver disease;

• high levels of triglycerides (lipids) in your blood;

• if you are also using methotrexate (Rheumatrex, Trexall); or

• if you are also using a tetracycline antibiotic, including demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), tetracycline (Brodspec, Panmycin, Sumycin, Tetracap), and others.

Acitretin is available only under an agreement that you will use birth control and undergo required pregnancy testing, and that you will not consume alcohol while you are taking acitretin and for 2 months after you stop taking it.

If you have any of the following conditions, you may need a dose adjustment or special tests to safely take acitretin:

• kidney or liver disease;

• heart disease;

• high cholesterol;

• diabetes (you may need to check your blood sugar more often);

• depression; or

• if you drink large amounts of alcohol.

Acitretin can cause birth defects. Do not use if you are pregnant or plan to become pregnant within 3 years after you stop taking acitretin. You must use 2 effective forms of birth control starting at least 1 month before treatment with acitretin, and for at least 3 years after you stop taking this medication. Use both forms of birth control together every time you have sex.

The first birth control method should include one of the following forms: birth control pills (but not the “mini-pill”), an intrauterine device (IUD), birth control shots, inserts, skin patches, or implants, a tubal ligation, or your male partner’s vasectomy.

The second birth control method should include one of the following forms: a latex condom, or a diaphragm or cervical cap used together with a spermicide cream or gel.

For women taking acitretin: Before using acitretin, you must have 2 negative pregnancy tests. The first test is given when your doctor prescribes acitretin. The second test must be given during the first 5 days of your menstrual period just before you start taking acitretin. No testing is needed if you have had a hysterectomy or have gone completely through menopause.

You will need monthly pregnancy tests while you are taking acitretin. If you are not menstruating, your pregnancy test should be done at least 11 days after you last had sex without using 2 effective forms of birth control.

Do not miss a scheduled pregnancy test or you may not be able to continue taking acitretin.

You will also need pregnancy tests every 3 months for at least 3 years after you stop taking this medication.

Call your doctor right away if you think you might be pregnant, if you miss a period, or if you have had sex without using the 2 recommended forms of birth control within 3 years of taking acitretin. Do not take acitretin if you are breast-feeding a baby. Acitretin may pass into breast milk and harm a nursing baby.

How should I take Soriatane (acitretin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Acitretin comes with patient instructions for safe and effective use. You will also be required to read and sign an agreement stating you will follow these directions carefully. Ask your doctor if you have any questions.

Acitretin is usually taken with your main meal of the day. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Your psoriasis may seem to get worse at the start of therapy. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after one course of acitretin treatment.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Never share this medicine with another person, even if they have the same symptoms you have.

Store acitretin at room temperature away from moisture, heat, and light.

See also: Soriatane dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, dizziness or spinning sensation, and nausea or vomiting.

What should I avoid while taking Soriatane (acitretin)?

Women taking acitretin must not drink alcohol during treatment and for at least 2 months after treatment ends. Alcohol can cause acitretin to convert to another substance in your body that can take 3 years or longer to clear from your body. Read the labels of all foods and medicines you consume to make sure they do not contain alcohol. Do not donate blood while taking acitretin and for at least 3 years after you stop taking it. Donated blood may be given to a pregnant woman and could cause birth defects if the blood contains acitretin.

Avoid taking vitamin supplements that contain vitamin A. Acitretin is a form of vitamin A, and taking too much can cause side effects similar to overdose symptoms.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Acitretin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Acitretin can cause side effects that may impair your vision, especially at night. Be careful if you drive or do anything that requires you to see clearly.

Soriatane (acitretin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acitretin and call your doctor at once if you have any of these serious side effects:

• blurred vision, headache or pain behind your eyes, sometimes with vomiting;

• sudden decrease in night vision;

• depressed mood, aggression, unusual thoughts or behavior, thoughts of hurting yourself;

• chest pain or heavy feeling, spreading to the arm or shoulder, sweating, shortness of breath;

• sudden headache, confusion, problems with speech or balance, numbness or weakness (especially on one side of the body);

• sudden cough, wheezing, rapid breathing, fast heart rate;

• pain or swelling in one or both legs;

• jaundice (yellowing of the skin or eyes); or

• loss of feeling in your hands or feet, trouble moving, pain in your back, joints, muscles, or bones.

Less serious side effects may include:

• dry or irritated eyes, thinning eyebrows or lashes;

• chapped or peeling skin, hair loss;

• dry mouth, dry or runny nose, nosebleeds;

• warmth, redness, or tingly feeling under your skin;

• nausea, diarrhea, stomach pain, loss of appetite;

• mouth sores, swollen or bleeding gums;

• headache;

• sleep problems (insomnia); or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Soriatane (acitretin)?

Before taking acitretin, tell your doctor if you are taking any of the following medicines:

• phenytoin (Dilantin); or

• St. John’s wort.

This list is not complete and there may be other drugs that can interact with acitretin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acitretin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.02. Revision Date: 11/17/2009 3:29:41 PM.