Prescribing Information/Medication Guide
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DEXEDRINE
DEXEDRINE


Important Safety Information

What is the most important information I should know about DEXEDRINE?
The following have been reported with use of DEXEDRINE and other stimulant medicines.

1. Heart-related problems:

  • Sudden death in patients who have heart problems or heart defects
  • Stroke and heart attack in adults
  • Increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.
Your doctor should check you or your child carefully for heart problems before starting DEXEDRINE.
Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with DEXEDRINE.

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 DEXEDRINE.

2. Mental (Psychiatric) problems:

All Patients

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking DEXEDRINE, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:

  • fingers or toes may feel numb, cool, 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 your fingers or toes.
Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking DEXEDRINE.

What is DEXEDRINE?
DEXEDRINE is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).
DEXEDRINE may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. DEXEDRINE should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. DEXEDRINE is also used in the treatment of a sleep disorder called narcolepsy.

DEXEDRINE is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DEXEDRINE in a safe place to prevent misuse and abuse. Selling or giving away DEXEDRINE 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.

Who should not take DEXEDRINE?
DEXEDRINE 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

DEXEDRINE is not recommended for use in children younger than 6 years old. DEXEDRINE may not be right for you or your child. Before starting DEXEDRINE 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 and toes

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can DEXEDRINE be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. DEXEDRINE and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking DEXEDRINE.

Your doctor will decide whether DEXEDRINE can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • Anti-depression medicines including MAOIs
  • Blood pressure medicines
  • Antacids
  • Seizure medicines

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist. Do not start any new medicine while taking DEXEDRINE without talking to your doctor first.

If you or your child takes too much DEXEDRINE or overdoses, call your doctor or poison control center right away, or get emergency treatment

What are possible side effects of DEXEDRINE?

See "What is the most important information I should know about DEXEDRINE?" for information on reported heart and mental problems.

Other serious side effects include:

  • Slowing of growth (height and weight) in children
  • Seizures, mainly in patients with a history of seizures
  • Eyesight changes or blurred vision

Common side effects include:

  • Fast heart beat
  • Decreased appetite
  • Tremors
  • Headache
  • Trouble sleeping
  • Dizziness
  • Stomach upset
  • Weight loss
  • Dry mouth

DEXEDRINE may affect your or your child's ability to drive or do other dangerous activities. Talk to your doctor if you or your child has side effects that are bothersome or do not go away. This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about DEXEDRINE
Do not give DEXEDRINE to other people, even if they have the same condition. It may harm them and it is against the law.

For a complete copy of the printed patient information/medication guide, please contact us at 1-888-894-6528.

Click here for full Prescribing Information/Medication Guide for DEXEDRINE.

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