April 29, 2017
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Trintellix

"The US Food and Drug Administration (FDA) has approved a brand name change for the antidepressant Brintellix (vortioxetine, Takeda) to decrease the risk of prescribing and dispensing errors due to name confusion with the antiplatelet Brilinta (ti"...

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Trintellix

TRINTELLIX
(vortioxetine) Tablet

WARNING

SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a trend toward reduced risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS].

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS].

TRINTELLIX has not been evaluated for use in pediatric patients [see Use in Specific Populations].

DRUG DESCRIPTION

TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18H22N2S, HBr with a molecular weight of 379.36 g/mol. The structural formula is:

TRINTELLIX (vortioxetine) Structural Formula Illustration

Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water.

Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).

Last reviewed on RxList: 4/13/2017
This monograph has been modified to include the generic and brand name in many instances.

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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