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FDA Labeling Changes
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Oleptro™ is indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of Oleptro has been established in a trial of outpatients with MDD as well as in trials with the immediate release formulation of trazodone [see Clinical Studies (14)].
There is currently no drug history available for this drug.
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.
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Colloidal silicon dioxide
Iron Oxide Yellow
Iron Oxide Red
Polyethylene Glycol 3350
Black ink (food grade)