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INDICATION and IMPORTANT SAFETY INFORMATION for
NUEDEXTA® (dextromethorphan HBr and quinidine sulfate)

INDICATION:

NUEDEXTA is approved for the treatment of Pseudobulbar Affect (PBA).

PBA is a medical condition that causes involuntary, sudden, and frequent episodes of crying and/or laughing in people living with certain neurologic conditions or brain injury. PBA episodes are typically exaggerated or don’t match how the person feels. PBA is distinct and different from other types of emotional changes caused by neurologic disease or injury.

NUEDEXTA is only available by prescription.

IMPORTANT SAFETY INFORMATION:

Before you take NUEDEXTA, tell your doctor:

  • If you are taking monoamine oxidase inhibitors (MAOIs), quinidine, or quinidine-related drugs. These can interact with NUEDEXTA causing serious side effects. MAOIs cannot be taken within 14 days before or after taking NUEDEXTA.
  • If you have previously had an allergic reaction to dextromethorphan, quinidine or quinidine-like drugs.
  • About all medicines, herbal supplements, and vitamins you take as NUEDEXTA and certain other medicines can interact causing side effects.
  • If you have had heart disease or have a family history of heart rhythm problems. NUEDEXTA may cause serious side effects, including changes in heart rhythm. If you have certain heart problems, NUEDEXTA may not be right for you. Your doctor may test your heart rhythm (heartbeats) before you start NUEDEXTA.
  • If you have myasthenia gravis.

IMPORTANT SAFETY INFORMATION: (Continued)

While taking NUEDEXTA, call your doctor right away:

  • If you feel faint or lose consciousness.
  • If you experience lightheadedness, chills, fever, nausea, or vomiting as these may be signs of an allergic reaction to NUEDEXTA. Hepatitis has been seen in patients taking quinidine, an ingredient in NUEDEXTA.
  • If you have unexplained bleeding or bruising. Quinidine, an ingredient in NUEDEXTA, can cause a reduction in the number of platelets in your blood which can be severe and, if left untreated, can be fatal.
  • If you feel dizzy, since it may increase your risk of falling.
  • If you have muscle twitching, confusion, high blood pressure, fever, restlessness, sweating, or shivering, as these may be signs of a potential drug interaction called serotonin syndrome.

The most common side effects of NUEDEXTA include: diarrhea, dizziness, cough, vomiting, weakness, and swelling of feet and ankles. This is not a complete list of side effects. Tell your doctor about any side effect that bothers you or does not go away.

You are encouraged to report side effects of NUEDEXTA® (dextromethorphan HBr and quinidine sulfate). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).

Please read FULL PRESCRIBING INFORMATION.