DEXEDRINE SPANSULE- dextroamphetamine sulfate capsule, extended release
Amedra Pharmaceuticals LLC
(dextroamphetamine sulfate) SPANSULE® sustained release capsules
Read the Medication Guide that comes with DEXEDRINE 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.
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:
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:
Children and Teenagers
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]:
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.
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.
DEXEDRINE should not be taken if you or your child:
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:
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:
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.
How should DEXEDRINE be taken?
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:
Common side effects include:
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.
How should I store DEXEDRINE?
General information about DEXEDRINE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use DEXEDRINE for a condition for which it was not prescribed. Do not give DEXEDRINE 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. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DEXEDRINE that was written for healthcare professionals. For more information about DEXEDRINE, please contact Amedra Pharmaceuticals at 1-888-894-6528 or visit www.amedrapharma.com.
What are the ingredients in DEXEDRINE?
Active Ingredient: Dextroamphetamine sulfate
SPANSULE Capsules: Cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres and trace amounts of other inactive ingredients.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Catalent Pharma Solutions
Winchester, KY 40391
Amedra Pharmaceuticals LLC
Horsham, PA 19044
LB# 797-07 Rev. October, 2013
For additional copies of the printed patient information/medication guide, please visit www.amedrapharma.com or contact us at 1-888-894-6528.