Healthcare Provider Patient Information

IMPORTANT SAFETY INFORMATION
Warning: SOTYLIZE contains sotalol. Sotalol can cause
serious side effects, including a type of abnormal heartbeat
called Torsade de Pointes, that can lead to death. Please see
additional Important Safety Information below.

Patient and Caregiver Instructions

It is important that you do not run out of your supply of Sotylize. Be sure to contact your pharmacy and order Sotylize a few days ahead of time to ensure your prescription is ready when you need it.

  • Sotylize does not need to be refrigerated or shaken prior to use
  • Always take or administer Sotylize exactly as your doctor instructs
  • It is important to accurately measure each Sotylize dose. When giving Sotylize to children and infants, use an appropriate measuring device (oral syringe), which is available at your pharmacy. Do not use a teaspoon or tablespoon to measure Sotylize doses
  • If you miss a dose of Sotylize, take or administer the next dose at the usual time. Do not take two doses at the same time
  • Do not stop taking or administering Sotylize unless instructed by your doctor
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You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION

Warning: SOTYLIZE contains sotalol. Sotalol can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, that can lead to death.

Please see Important Safety Information below, as well as the full Prescribing Information.

DO NOT TAKE SOTYLIZE IF YOU:

  • have a very slow heartbeat (bradycardia) or certain heart conditions called sick sinus syndrome or heart block, and you do not have an implanted pacemaker
  • have a heart problem called congenital long QT syndrome, or develop long QT syndrome
  • have uncontrolled heart failure
  • have certain kidney problems
  • have been told by your doctor that you have a low level of potassium in your blood
  • have asthma or other lung or breathing problems that cause shortness of breath or wheezing
  • are allergic to sotalol

Tell your doctor about all your medical conditions, including if you have had severe allergic reactions to anything in the past, heart problems, kidney problems, asthma or other lung or breathing problems.

Tell your doctor if you are pregnant or plan to become pregnant. SOTYLIZE can pass into your milk and may harm your baby. You and your doctor should decide if you will take SOTYLIZE or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Taking SOTYLIZE with other medicines can cause serious side effects. Tell your doctor if you take another medicine that contains sotalol. You should not take SOTYLIZE if you also take another medicine that contains sotalol.

SOTYLIZE CAN CAUSE SERIOUS SIDE EFFECTS INCLUDING:

  • Slow heartbeat (bradycardia) which increases your risk of developing a serious abnormal heartbeat. Your doctor will check you for this problem, especially if you take the medicine digoxin.
  • New or worsening heart failure. Symptoms of worsening heart failure include shortness of breath and fatigue. If these occur, contact your doctor.
  • If you have diabetes, SOTYLIZE can make it more difficult for you to tell if you have low blood sugar (hypoglycemia). Certain important signs of low blood sugar, such as a fast heartbeat, may be hidden.
  • If you have an overactive thyroid gland (hyperthyroidism), SOTYLIZE can make it more difficult for you to tell if you are having symptoms of too much thyroid hormone in your blood. Certain signs of having too much thyroid hormone in your blood, such as a fast heartbeat, may be hidden. If you stop taking SOTYLIZE suddenly, your symptoms of having too much thyroid hormone in your blood may become much worse, and could be life-threatening.
  • Severe allergic reactions. People who have had severe allergic reactions in the past to other things may have a more severe allergic reaction when taking medicines like SOTYLIZE.
  • Possible side effects to anesthesia. SOTYLIZE may cause severe low blood pressure and heart rhythm problems in people who receive anesthesia for major surgery. Tell your doctor that you are taking SOTYLIZE if you need to have surgery during treatment with SOTYLIZE.

Call your doctor right away if you have any of the following symptoms that may be signs of an irregular heartbeat: fainting, dizziness, or fast heartbeat.

The most common side effects of SOTYLIZE include tiredness, headache, slow heart rate, and dizziness.

Changes in the level of body salts (electrolytes) in your blood can lead to serious side effects during treatment with SOTYLIZE. Call your doctor if you have any of the following symptoms: severe diarrhea, unusual sweating, vomiting, less appetite than normal, or increased thirst (drinking more than normal).

Tell your doctor if you have any side effect that bothers you or that does not go away.

Please talk to your healthcare professional and see complete Prescribing Information for SOTYLIZE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For further information, please see Prescribing Information for SOTYLIZE.