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Escitalopram 10 MG Oral Tablet

1 INDICATIONS AND USAGE Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 to 17 years ( 1.1 ) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2 ) 1.1 Major Depressive Disorder Escitalopram tablet, is indicated for the acute and maintenance Treatment of Major Depressive Disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1 ) ]. A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. 1.2 Generalized Anxiety Disorder Escitalopram tablet, is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies ( 14.2 ) ]. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

rpk pharmaceuticals, inc.


9 months ago ROUND WHITE 10 Escitalopram 10 MG Oral Tablet

ROUND WHITE 10

9 months ago ROUND WHITE 10 Escitalopram 10 MG Oral Tablet

10 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 53002-1438 NDC: 53002-1438-3 30 TABLET, film coated in a BOTTLE NDC: 53002-1438-6 60 TABLET, film coated in a BOTTLE NDC: 53002-1438-0 100 TABLET, film coated in a BOTTLE Product: 53002-1453 NDC: 53002-1453-3 30 TABLET, film coated in a BOTTLE NDC: 53002-1453-6 60 TABLET, film coated in a BOTTLE NDC: 53002-1453-0 100 TABLET, film coated in a BOTTLE


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