Trintellix 5 mg/1
vortioxetine · TABLET, FILM COATED · Takeda Pharmaceuticals America, Inc.
Trintellix is a tablet, film coated containing vortioxetine at 5 mg/1, taken oral. Manufactured by Takeda Pharmaceuticals America, Inc..
Key Facts
- Brand Name
- Trintellix
- Generic Name
- vortioxetine
- NDC Code (Product)
64764-720- Manufacturer
- Takeda Pharmaceuticals America, Inc.
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA204447
- Marketing Start
- 10/02/2013
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults. TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 , 14 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose is 10 mg administered orally once daily without regard to meals ( 2.1 ). The dose should then be increased to 20 mg/day, as tolerated ( 2.1 ). Consider 5 mg/day for patients who do not tolerate higher doses ( 2.1 ). 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 ( 2.3 ). The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers ( 2.5 ). 2.1 Recommended Dosage The recommended starting dose is 10 mg administered orally once daily without regard to meals. Dosage should then be increased to 20 mg/day, as tolerated. The efficacy and safety of doses above 20 mg/day have not been evaluated in controlled clinical trials. A dose decrease down to 5 mg/day may be considered for patients who do not tolerate higher doses [see Clinical Studies (14) ] . 2.2 Screen for Bipolar Disorder Prior to Starting TRINTELLIX Prior to initiating treatment with TRINTELLIX or another antidepressant, screen patients for personal or family history of bipolar disorder, mania, or hypomania [see Warnings an…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to vortioxetine or any component of the formulation. Hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in patients treated with TRINTELLIX [see Adverse Reactions (6.2) ] . The use of MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX is contraindicated because of an increased risk of serotonin syndrome. The use of TRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.4) , Warnings and Precautions (5.2) ] . Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) ] . Hypersensitivity to vortioxetine or any components of the TRINTELLIX formulation ( 4 ). Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with TRINTELLIX or within 21 days of stopping treatment with TRINTELLIX. Do not use TRINTELLIX within 14 days of stopping an MAOI intended t…
Drug Interactions
7 DRUG INTERACTIONS Strong inhibitors of CYP2D6: Reduce TRINTELLIX dose by half when coadministered ( 2.5 , 7.1 ). Strong CYP Inducers: Consider dose increase of TRINTELLIX dose when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose ( 2.6 , 7.1 ). 7.1 Drugs Having Clinically Important Interactions with TRINTELLIX Table 4: Clinically Important Drug Interactions with TRINTELLIX Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact The concomitant use of SSRIs and SNRIs including TRINTELLIX with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of TRINTELLIX is contraindicated: With an MAOI intended to treat psychiatric disorders or within 21 days of stopping treatment with TRINTELLIX. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. In a patient who is being treated with linezolid or intravenous methylene blue. [see Dosage and Administration (2.4) , Contraindications (4) , Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of TRINTELLIX with ot…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see Contraindications (4) ] Clinical Worsening and Suicide Risk [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Increased Risk of Bleeding [see Warnings and Precautions (5.3) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.4) ] Discontinuation Syndrome [see Warnings and Precautions (5.5) ] Angle Closure Glaucoma [see Warnings and Precautions (5.6) ] Hyponatremia [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were: nausea, constipation and vomiting ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical pra…
Frequently Asked Questions
What is Trintellix used for?
Trintellix contains vortioxetine. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Trintellix a controlled substance?
Trintellix is not classified as a controlled substance by the DEA.
What is the generic name for Trintellix?
The generic name for Trintellix is vortioxetine. There are no other listed brand versions of vortioxetine.
What is the NDC code for Trintellix 5 mg/1?
The NDC (National Drug Code) for Trintellix 5 mg/1 is 64764-720, listed by Takeda Pharmaceuticals America, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)