Zenzedi® (dextroamphetamine sulfate, USP)
Prescribing Information & Medication Guide Important Safety Information
Indication: Zenzedi (dextroamphetamine sulfate) is a prescription medicine for the treatment of narcolepsy. Zenzedi is also indicated as a treatment for ADHD in pediatric patients ages 3 to 16 years as an integral part of a total treatment program for ADHD that may include counseling or other therapies.

Every ADHD Patient’s Needs Are Different

Indication

Zenzedi (dextroamphetamine sulfate) is a prescription medicine for the treatment of narcolepsy. Zenzedi is also indicated as a treatment for ADHD in pediatric patients ages 3 to 16 years as an integral part of a total treatment program for ADHD that may include counseling or other therapies.

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Important Safety Information

Zenzedi (dextroamphetamine sulfate) is a federally controlled substance (CII) with a high risk of abuse or dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Zenzedi may harm others and is illegal.

Do not take Zenzedi if you or your child:

  • has a history of advanced heart disease or hardening of the arteries, moderate to severe high blood pressure, hyperthyroidism, known hypersensitivity or other serious cardiac problems that may place you or your child at increased vulnerability to the sympathomimetic effects of a stimulant drug or glaucoma
  • is very anxious, tense or agitated
  • has a history of drug abuse
  • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI

Warnings and Precautions

Serious heart problems can occur when taking stimulant medicines, such as Zenzedi, and include:

  • sudden death in people who have heart problems or heart defects
  • sudden death, stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems including heart defects, abnormal heart rhythm, high blood pressure, disease known as cardiomyopathy, coronary artery disease, or a family history of these problems or sudden cardiac death. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Zenzedi.

Mental (psychiatric) problems can occur including:

  • new or worsening behavior and thought problems
  • new or worsening bipolar illness

New aggressive behavior or psychotic symptoms can occur in children and teenagers such as:

  • seeing things or hearing voices
  • believing things that are not true
  • being suspicious

Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had, or about a family history of suicide, bipolar illness, or depression, new or worsening aggressive behavior or hostility. Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Zenzendi.

Zenzedi may cause serious side effects, including:

  • slowing of growth (height and weight) in children. Your child should have his or her height and weight checked often while taking Zenzedi. The doctor may stop treatment if a problem is found during these check-ups.

The most common side effects reported with Zenzedi treatment were:

• seizures • rapid heart beat • trouble sleeping • weight loss
• blurred vision • tremors • stomach upset • dizziness
• dry mouth • decreased appetite • headache

For additional safety information, consult the Zenzedi full Prescribing Information and Medication Guide.

Talk to your doctor to see if Zenzedi is right for you or your child.

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.