Hypothetical patient portrayal

INDICATION AND USAGE

ProCentra (dextroamphetamine sulfate) Oral Solution CII is a central nervous system stimulant prescription medicine. It is used in patients (3 to 16 years of age) for the treatment of Attention-Deficit Disorder with Hyperactivity (ADHD). ProCentra may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
ProCentra should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

IMPORTANT SAFETY INFORMATION
ProCentra (dextroamphetamine sulfate) Oral Solution is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep ProCentra in a safe place to prevent misuse and abuse. Selling or giving away ProCentra may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

  • • ProCentra should not be taken if you or your child:
    • – have heart disease or hardening of the arteries
    • – have moderate to severe high blood pressure
    • – have hyperthyroidism
    • – have an eye problem called glaucoma
    • – are very anxious, tense, or agitated
    • – have a history of drug abuse
    • – are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI
    • – is sensitive to, allergic to, or had a reaction to other stimulant medicines
  • • Before starting ProCentra tell your or your child’s doctor about all health conditions (or a family history of) including:
    • – heart problems, heart defects, high blood pressure
    • – mental problems including psychosis, mania, bipolar illness, or depression
    • – tics or Tourette’s syndrome
    • – thyroid problems
    • – seizures or have had an abnormal brain wave test (EEG)
    • – circulation problems in fingers or toes, and or sensitivity to temperature in fingers or toes
  • • Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
  • • 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 ProCentra.
  • • Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking ProCentra, especially seeing things or hearing voices that are not real, believing things that are not real, or being suspicious.
  • • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon) have been reported with methylphenidate hydrochloride and other stimulant medicines:
    • · Fingers or toes may feel numb, cool, or painful
    • · Fingers or toes may change color from pale, to blue, to red
  • • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
  • • Call your physician right away if you or your child experience any heart-related symptoms, such as chest pain, shortness of breath or fainting, new or worsening mental (psychiatric) symptoms or new manic symptoms, or signs of unexplained wounds appearing on fingers or toes while taking Procentra.
  • • Other potential side effects of stimulant medications include aggressive behavior or hostility; new abnormal behaviors/thoughts; seizures; muscle pain and muscle weakness; and blurred vision. Tell your doctor immediately if you or your child experience any of these symptoms while taking ProCentra.
  • • Stimulants may adversely affect you or your child’s ability to drive or operate potentially dangerous machinery. Caution should be taken while engaging in these types of activities.
  • The most common side effects associated with stimulants like ProCentra are: rapid heartbeat; tremors; trouble sleeping; upset stomach; dry mouth; decreased appetite; headache; dizziness; and weight loss. Talk with your doctor if you or your child experience any side effects that may be bothersome or do not go away.
  • • Especially tell your doctor if you or your child takes:
    • – Anti-depression medicines including MAOIs
    • – antacids
    • – blood pressure medicines
    • – seizure medicines

 

This is not a complete summary of safety information. For additional safety information, please click here for Full Prescribing Information and Medication Guide and discuss with your doctor.
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.