escitalopram tablet film coated
1 INDICATIONS AND USAGE Escitalopram tablets are 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.
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16 HOW SUPPLIED/STORAGE AND HANDLING Escitalopram Tablets USP, 5 mg are available as white to off-white, round, biconvex, unscored, film-coated tablets, debossed â5850â on one side and âIvax hourglass logoâ â5â on the other side, packaged in bottles of 100 (0093-5850-01) and 500 (0093-5850-05) tablets. Escitalopram Tablets USP, 10 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed â5851â on one side and âIvax hourglass logoâ, a score, and â10â on the other side, packaged in bottles of 100 (0093-5851-01) and 500 (0093-5851-05) tablets. Escitalopram Tablets USP, 20 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed â5852â on one side and âIvax hourglass logoâ, a score, and â20â on the other side, packaged in bottles of 100 (0093-5852-01) and 500 (0093-5852-05) tablets. Storage and Handling Store at 20Â° to 25Â°C (68Â° to 77Â°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure as required. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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