TRINTELLIX (vortioxetine) tablets - America[美国药品]

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TRINTELLIX (vortioxetine) tablets

2016-06-22 09:58:32 来源: 作者: 【大中小】浏览:411次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use TRINTELLIX safely and effectively. See full prescribing information for TRINTELLIX.
TRINTELLIX (vortioxetine) tablets, for oral use
Initial U.S. Approval: 2013
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 (5.1).
•: Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1).
•: TRINTELLIX has not been eva luated for use in pediatric patients (8.4).

RECENT MAJOR CHANGES

: Warnings and Precautions ( 5.5) 7/2014

INDICATIONS AND USAGE

TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) (1, 14).

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 (