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(trazodone hydrochloride) Extended-release Tablets
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 [see WARNINGS AND PRECAUTIONS and PATIENT INFORMATION].
Oleptro (trazodone hydrochloride) is a triazolopyridine. It is a white, odorless crystalline powder which is freely soluble in water.
Chemical Name: 2-[3-[4-(m-Chlorophenyl)-1-piperazinyl]propyl]-s-triazolo[4,3-a]pyridin-3(2H)-one monohydrochloride
Molecular Formula: C19H22ClN5O •HCl
Molecular Weight: 408.32
Oleptro tablets containing 150 mg or 300 mg of trazodone hydrochloride are designed to release their drug content over a 24-hour period and are intended for once-a-day dosing.
Hydroxypropyl distarch phosphate (Contramid®)
Sodium stearyl fumarate
Colloidal silicon dioxide
Iron Oxide Yellow
Iron Oxide Red
Polyethylene Glycol 3350
Black ink (food grade)
What are the possible side effects of trazodone (Desyrel, Oleptro)?
Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 6 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable,...
Last reviewed on RxList: 8/1/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Oleptro Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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