OLEPTRO? is indicated for the treatment of major depressive disorder (MDD) in adults.
What is the most important information I should know about OLEPTRO??
Important Safety Information for Patients
The following information does not include everything you should know about OLEPTRO?. For more complete information about the use of OLEPTRO?, please see the enclosed Medication Guide. Read the Medication Guide that comes with OLEPTRO? before you start taking this medication and each time you get a refill. There may be new information.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Oleptro or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Oleptro is not approved for use in pediatric patients.
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 higher 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?
Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
This is especially important when an antidepressant medicine is started or when the dose is changed.
Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings.
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Call a healthcare provider right away if you have 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
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. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of your medicines.
Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.
OLEPTRO? is not approved for use in children. Talk to your healthcare provider for more information.
What should I tell my healthcare provider before taking OLEPTRO??
Before you take OLEPTRO?, tell your healthcare provider if you:
Have heart problems, including QT prolongation (irregular or fast heartbeat or fainting) or a family history of it
Have ever had a heart attack
Have bipolar disorder
Have liver or kidney problems