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 tablets are 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 tablets are 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.
aurobindo pharma limited
16 HOW SUPPLIED/STORAGE AND HANDLING Escitalopram Tablets USP, 5 mg are white to off-white, round, biconvex film-coated tablets debossed with âFâ on one side and â53â on the other side. Bottles of 30 NDC 65862-373-30 Bottles of 90 NDC 65862-373-90 Bottles of 100 NDC 65862-373-01 Bottles of 500 NDC 65862-373-05 Bottles of 10,000 NDC 65862-373-19 10 x 10 Unit-dose Tablets NDC 65862-373-10 Escitalopram Tablets USP, 10 mg are white to off-white, oval shaped, biconvex film-coated tablets debossed with âFâ on one side and â54â on the other side with a deep scoreline between â5â and â4â. Bottles of 30 NDC 65862-374-30 Bottles of 90 NDC 65862-374-90 Bottles of 100 NDC 65862-374-01 Bottles of 500 NDC 65862-374-05 Bottles of 5,000 NDC 65862-374-59 10 x 10 Unit-dose Tablets NDC 65862-374-10 Escitalopram Tablets USP, 20 mg are white to off-white, oval shaped, biconvex film-coated tablets debossed with âFâ on one side and â56â on the other side with a deep scoreline between â5â and â6â. Bottles of 30 NDC 65862-375-30 Bottles of 90 NDC 65862-375-90 Bottles of 100 NDC 65862-375-01 Bottles of 500 NDC 65862-375-05 Bottles of 3,000 NDC 65862-375-39 10 x 10 Unit-dose Tablets NDC 65862-375-10 Storage and Handling Store at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted to 15Â° to 30Â°C (59Â° to 86Â°F) [see USP Controlled Room Temperature].
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