|WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
•Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
|TRINTELLIX (vortioxetine) tablets, for oral use
Initial U.S. Approval: 2013
TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (ß) 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 C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol.
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, 19.065 mg, or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, 15 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, 15 mg, and 20 mg) and iron oxide yellow (10 mg and 15 mg).
| Mechanism of Action:
The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established.
|INDICATIONS AND USAGE:
TRINTELLIX is indicated for the treatment of major depressive disorder (MDD)
|Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation.
Monoamine Oxidase Inhibitors (MAOIs):
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
>Strong CYP Inducers: Consider increasing TRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose.
USE IN SPECIFIC POPULATIONS
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
|DOSAGE AND ADMINISTRATION:
The recommended starting dose is 10 mg administered orally once daily without regard to meals.
The dose should then be increased to 20 mg/day, as tolerated.
TRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible.
The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers
|DOSAGE FORMS AND STRENGTHS
TRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets
|Package insert data: [Accessed:: Jan 2014]
Distributed and Marketed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015
TRINTELLIX is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America, Inc.
All other trademarks are the property of their respective owners.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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