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IMPORTANT SAFETY INFORMATION
Warning: LIFE THREATENING PROARRHYTHMIA
Please see complete boxed warning and additional
Important Safety Information below.

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INDICATIONS

SOTYLIZE® is a prescription medicine used to treat life-threatening heart rhythm problems called ventricular arrhythmias. SOTYLIZE is also used to increase the amount of time between having symptoms of heart rhythm disorders called atrial fibrillation or atrial flutter.

IMPORTANT SAFETY INFORMATION

WARNING: LIFE-THREATENING PROARRHYTHMIA

See full prescribing information for complete boxed warning.

  • Sotalol can cause life-threatening ventricular tachycardia associated with QT interval prolongation.
  • If the QT interval prolongs to 500 msec or greater, reduce the dose, lengthen the dosing interval, or discontinue the drug.
  • Initiate or reinitiate in facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring.
  • Adjust the dosing interval based on creatinine clearance.

DO NOT TAKE SOTYLIZE IF YOU:

  • have a very slow heartbeat 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 or acquired long QT syndrome or have a baseline QT interval of more than 450 msec
  • have a life-threatening heart condition called cardiogenic shock decompensated 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

Contact your healthcare provider in the event of:

  • Syncope, pre-syncopal symptoms, and cardiac palpitations
  • Conditions conducive to electrolyte changes such as severe diarrhea, unusual sweating, vomiting, less appetite than normal or excessive thirst
  • Hypoglycemia symptoms. There is a risk of hypoglycemia when SOTYLIZE is given to patients who are fasting or who are vomiting
  • Any side effect that bothers you or that does not go away

Do not change the SOTYLIZE dose prescribed by your healthcare provider. You should not miss a dose, but if you do miss a dose you should not double the next dose to compensate for the missed dose. You should take the next dose at the regularly scheduled time.

Do not interrupt or discontinue SOTYLIZE without your healthcare provider’s advice. You should fill and refill your prescription of SOTYLIZE on time, to avoid interruptions in treatment.

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

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Tell your healthcare provider before starting other medications. Taking SOTYLIZE with other medicines can cause serious side effects. Avoid taking SOTYLIZE within 2 hours of taking antacids that contain aluminum oxide or magnesium hydroxide.

SOTYLIZE can cause serious side effects including:

  • Slow heartbeat (bradycardia which increases your risk of developing a serious abnormal heartbeat. Your healthcare provider 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 healthcare provider.
  • 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 healthcare provider that you are taking SOTYLIZE if you need to have surgery during treatment with SOTYLIZE.

The most common side effects of SOTYLIZE include tiredness, headache, slow heart rate, shortness of breath, development of a new irregular heartbeat or worsen of an existing one, weakness, and dizziness.

The Important Safety Information does not include all the information needed to use SOTYLIZE safely and effectively.

For further information, please see accompanying complete Prescribing Information for SOTYLIZE.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

SOTYLIZE® is a registered trademark of Azurity Pharmaceuticals, Inc.

© 2024 Azurity Pharmaceuticals, Inc.

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