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:
âEUR¢ Sudden death in patients who have heart problems or
heart defects
âEUR¢ Stroke and heart attack in adults
âEUR¢ 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 childâEUR(TM)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
âEUR¢ new or worse behavior and thought problems
âEUR¢ new or worse bipolar illness
âEUR¢ new or worse aggressive behavior or hostility
Children and Teenagers
âEUR¢ 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.
What Is DEXEDRINE?
DEXEDRINE is a central nervous system stimulant
prescription medicine. It is used for the treatment of
Attention-Deficit Hyperactivity Disorder (ADHD).
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:
âEUR¢ Have heart disease or hardening of the arteries
âEUR¢ Have moderate to severe high blood pressure
âEUR¢ Have hyperthyroidism
âEUR¢ Have an eye problem called glaucoma
âEUR¢ Are very anxious, tense, or agitated
âEUR¢ Have a history of drug abuse
âEUR¢ Are taking or have taken within the past 14 days an
antidepression medicine called a monoamine oxidase
inhibitor or MAOI.
âEUR¢ Is sensitive to, allergic to, or had a reaction to other
stimulant medicines
DEXEDRINE is not recommended for use in children less than
3 years old.
DEXEDRINE may not be right for you or your child.
Before starting DEXEDRINE tell your or your childâEUR(TM)s
doctor about all health conditions (or a family history of)
including:
âEUR¢ Heart problems, heart defects, high blood pressure
âEUR¢ Mental problems including psychosis, mania, bipolar
illness, or depression
âEUR¢ Tics or TouretteâEUR(TM)s syndrome
âEUR¢ Thyroid problems
âEUR¢ 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 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:
âEUR¢ Anti-depression medicines including MAOIs
âEUR¢ Blood pressure medicines
âEUR¢ Antacids
âEUR¢ 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.
How should DEXEDRINE be taken?
âEUR¢ Take DEXEDRINE exactly as prescribed. Your doctor
may adjust the dose until it is right for you or your child.
âEUR¢ DEXEDRINE comes as a capsule or tablet.
o DEXEDRINE SPANSULE capsules are usually taken
once a day in the morning. DEXEDRINE SPANSULE
is an extended release capsule. It releases medicine into
your body throughout the day.
o 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.
âEUR¢ From time to time, your doctor may stop DEXEDRINE®
treatment for a while to check ADHD symptoms.
âEUR¢ Your doctor may do regular checks of the blood, heart, and
blood pressure while taking DEXEDRINE. Children should
have their height and weight checked often while taking
DEXEDRINE. DEXEDRINE treatment may be stopped if a
problem is found during these check-ups.
âEUR¢ 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 âEURoeWhat is the most important information I should
know about DEXEDRINE?âEUR for information on reported
heart and mental problems.
Other serious side effects include:
âEUR¢ Slowing of growth (height and weight) in children
âEUR¢ Seizures, mainly in patients with a history of seizures
âEUR¢ Eyesight changes or blurred vision
Common side effects include:
âEUR¢ Fast heart beat âEUR¢ Decreased appetite
âEUR¢ Tremors âEUR¢ Headache
âEUR¢ Trouble sleeping âEUR¢ Dizziness
âEUR¢ Stomach upset âEUR¢ Weight loss
âEUR¢ Dry mouth
DEXEDRINE may affect you or your childâEUR(TM)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.
How should I store DEXEDRINE?
âEUR¢ Store DEXEDRINE SPANSULE capsules in a safe place at
room temperature, 68 to 77°F (20 to 25°C). Protect from
light.
âEUR¢ Store DEXEDRINE Tablets in a safe place at room
temperature, 59 to 86°F (15 to 30°C). Protect from light.
âEUR¢ Keep DEXEDRINE and all medicines out of the reach of
children.
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 GlaxoSmithKline (makers
of DEXEDRINE) at 1-888-825-5249 or visit www.gsk.com.
What are the ingredients in DEXEDRINE?
Active Ingredient: Dextroamphetamine sulfate
Inactive Ingredients:
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, propylene glycol, povidone,
silicon dioxide, sodium laurate sulfate, and sugar spheres
Tablets: Calcium sulfate, FD&C Yellow No. 5, FD&C Yellow
No. 6, gelatin, lactose, mineral oil, starch, stearic acid, sucrose,
and talc


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