MEDICATION GUIDE
ABILIFY® (a
BIL ĭ fī)
Generic name: aripiprazole
Antidepressant Medicines, Depression and other Serious
Mental Illnesses, and Suicidal Thoughts or Actions
Read the Medication Guide that comes with your or your family member’s
antidepressant medicine. This Medication Guide is only about the risk of
suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider
about:
- all risks and benefits of treatment with antidepressant medicines
- all treatment choices for depression or other serious mental illness
What is the most important information I should know about
antidepressant medicines, depression and other serious mental illnesses, and
suicidal thoughts or actions?
-
Antidepressant medicines may increase suicidal thoughts or
actions in some children, teenagers, and young adults within the first few
months of treatment.
-
Depression and other serious mental illnesses are the most
important causes of suicidal thoughts and actions. Some people may have a
particularly high risk of having suicidal thoughts or actions. These
include people who have (or have a family history of) bipolar illness (also
called manic-depressive illness) or suicidal thoughts or actions.
-
How can I watch for and try to prevent suicidal thoughts
and actions in myself or a family member?
- Pay close attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings. This is very important when an antidepressant
medicine is started or when the dose is changed.
- Call the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with the healthcare provider as scheduled. Call
the healthcare provider between visits as needed, especially if you have
concerns about symptoms.
Call a healthcare provider right away if you or your family
member has any of the following symptoms, especially if they are new, worse, or
worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
What else do I need to know about antidepressant
medicines?
-
Never stop an antidepressant medicine without first talking
to a healthcare provider. Stopping an antidepressant medicine suddenly
can cause other symptoms.
-
Antidepressants are medicines used to treat depression and
other illnesses. It is important to discuss all the risks of treating
depression and also the risks of not treating it.
Patients and their families or other caregivers should discuss all treatment
choices with the healthcare provider, not just the use of antidepressants.
-
Antidepressant medicines have other side effects.
Talk to the healthcare provider about the side effects of the medicine
prescribed for you or your family member.
-
Antidepressant medicines can interact with other
medicines. Know all of the medicines that you or your family member
takes. Keep a list of all medicines to show the healthcare provider. Do not
start new medicines without first checking with your healthcare provider.
-
Not all antidepressant medicines prescribed for children
are FDA approved for use in children. Talk to your child’s healthcare
provider for more information.
This Medication Guide has been approved by the U.S. Food and Drug
Administration for all antidepressants.
It should be noted that ABILIFY is approved to be added to an antidepressant
when the response from the antidepressant alone is not adequate. ABILIFY is not
approved for pediatric patients with depression.
Call your doctor for medical advice about side effects. You may report side
effects to FDA at 1-800-FDA-1088.
ABILIFY is a trademark of Otsuka Pharmaceutical Company.
1239550A7 0309L-2745C Rev November 2009
© 2009, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan
---------------------------------------------
REPRESENTATIVE
PACKAGING
See How Supplied section for a complete list of
available packages of ABILIFY®
30 Tablets NDC 59148-006-13
ABILIFY®
(aripiprazole)
TABLETS
2 mg
DISPENSE WITH MEDICATION GUIDE
Rx
only
Otsuka America Pharmaceutical, Inc.
Bristol-Myers Squibb