Venlafaxine Hydrochloride, Extended Release

1 INDICATIONS AND USAGE Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies ( 14.1 )] .

6 ADVERSE REACTIONS Major Depressive Disorder - Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating.

8.1 Pregnancy Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.13) and Clinical Considerations]. Teratogenic Effects Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis.

BOXED WARNING WARNING: Suicidality and antidepressant drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Venlafaxine Hydrochloride Extended-Release Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 5 WARNINGS AND PRECAUTIONS Serotonin Syndrome : Serotonin syndrome has been reported with SSRIs and SNRIs, including venlafaxine hydrochloride extended-release tablets, both when taken alone, but especially when co-administered with other serotonergic agents. If such symptoms occur, discontinue venlafaxine hydrochloride extended-release tablets and serotonergic agents and initiate supportive treatment. If concomitant use of Venlafaxine Hydrochloride Extended-Release Tablets with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2 ). Suicidality: Monitor for clinical worsening and suicide risk. ( 5.1 ) Sustained hypertension may occur. 4 CONTRAINDICATIONS Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with venlafaxine hydrochloride extended-release tablets or within 7 days of stopping treatment with Venlafaxine Hydrochloride Extended-Release Tablets. Do not use venlafaxine hydrochloride extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders.