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escitalopram tablet film coated

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.

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1 year ago ROUND WHITE 20 escitalopram tablet film coated

ROUND WHITE 20

1 year ago ROUND WHITE 20 escitalopram tablet film coated

20 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING Tablets 5 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-168-10 Bottle of 100’s count with child-resistant closure NDC 16729-168-01 Bottle of 500’s count NDC 16729-168-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-168-17 10 x 10 Unit Dose NDC 16729-168-17 white to off-white, round, biconvex, film coated tablets, debossed with “5” on one side and plain on other side. 10 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-169-10 Bottle of 100’s count with child-resistant closure NDC 16729-169-01 Bottle of 500’s count NDC 16729-169-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-169-17 10 x 10 Unit Dose NDC 16729-169-43 white to off-white, round, biconvex, film -coated tablets, debossed with "10” on one side and break line on other side. 20 mg Tablets: Bottle of 30’s count with child-resistant closure NDC 16729-170-10 Bottle of 100’s count with child-resistant closure NDC 16729-170-01 Bottle of 500’s count NDC 16729-170-16 Bottle of 1,000’s count with child-resistant closure NDC 16729-170-17 10 x 10 Unit Dose NDC 16729-170-43 white to off-white, round, biconvex, film coated tablets, debossed with “20” on one side and break line on other side. Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature].

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