MEDICATION GUIDE
DEXEDRINE® (dextroamphetamine sulfate, USP) Tablets CII
(DĔX-ĕ-drin)

Read the Medication Guide that comes with DEXEDRINE tablets before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child's treatment with DEXEDRINE tablets.

What is the most important information I should know about DEXEDRINE tablets? The following have been reported with use of DEXEDRINE tablets 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 tablets. Your doctor should check you or your child's blood pressure and heart rate regularly during treatment with DEXEDRINE tablets. 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 tablets. 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 has any new or worsening mental symptoms or problems while taking DEXEDRINE tablets, 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 vasuclopathy, 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 tablets. DEXEDRINE tablets may not be right for you or your child. Before starting DEXEDRINE tablets tell your or your child's doctor about all health conditions (or a family history of) including: circulation problems in fingers and toes

What are DEXEDRINE tablets?

DEXEDRINE tablets are a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

DEXEDRINE tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

DEXEDRINE tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

DEXEDRINE tablets are also used in the treatment of a sleep disorder called narcolepsy.

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

DEXEDRINE tablets 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 anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• is sensitive to, allergic to, or had a reaction to other stimulant medicines

DEXEDRINE tablets are not recommended for use in children less than 3 years old.

DEXEDRINE tablets may not be right for you or your child. Before starting DEXEDRINE tablets 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)

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

Can DEXEDRINE tablets be taken with other medicines?

Tell your doctor about all of the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.

DEXEDRINE tablets 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 tablets. 

Your doctor will decide whether DEXEDRINE tablets 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 tablets without talking to your doctor first.

How should DEXEDRINE tablets be taken?

• Take DEXEDRINE tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• DEXEDRINE tablets are usually taken two to three times a day. The first dose is usually taken in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
• From time to time, your doctor may stop DEXEDRINE tablets treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking DEXEDRINE tablets. Children should have their height and weight checked often while on DEXEDRINE tablets. DEXEDRINE tablets treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much DEXEDRINE tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of DEXEDRINE tablets?

See "What is the most important information I should know about DEXEDRINE tablets?" 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
• Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as DEXEDRINE are taken with certain other medicines. Symptoms of serotonin syndrome may include:
  • agitation, hallucinations, coma or other changes in mental status
  • problems controlling your movements or muscle twitching
  • fast heartbeat
  • high or low blood pressure
  • sweating or fever
  • nausea or vomiting
  • diarrhea
  • muscle stiffness or tightness

Common side effects include:

• fast heart beat
• decreased appetite
• tremors
• headache
• trouble sleeping 
• dizziness
• stomach upset 
• weight loss 
• dry mouth

DEXEDRINE tablets may affect you 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.

How should I store DEXEDRINE tablets?

• Store DEXEDRINE tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).
• Keep DEXEDRINE tablets and all medicines out of the reach of children.

General information about DEXEDRINE tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXEDRINE tablets for a condition for which it was not prescribed. Do not give DEXEDRINE tablets to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about DEXEDRINE tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXEDRINE tablets that was written for healthcare professionals. For more information about DEXEDRINE tablets, you may also contact Amedra Pharmaceuticals LLC at 1-888-894-6528.

What are the ingredients in DEXEDRINE tablets?

Active Ingredients: dextroamphetamine sulfate

Inactive Ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and D&C Red # 27 Aluminum Lake.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

LB# 897-02                                                                    Rev. September, 2016        

Distributed by:
Amedra Pharmaceuticals LLC
Horsham, PA 19044

For additional copies of the printed patient information/medication guide, please visit www.amedrapharma.com or call 1-888-894-6528.