Escitalopram Escitalopram 5 MG Oral Tablet
1 INDICATIONS AND USAGE Escitalopram 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 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 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 six months and which the person finds difficult to control. It must be associated with at least three 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.
Camber Pharmaceuticals
ROUND WHITE IG 249
IG 249 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Tablets: Escitalopram Tablets, USP 5 mg, 10 mg and 20 mg are supplied as follows: 5 mg Tablets: white, film coated, round, biconvex tablets debossed with IG on one side and 249 on other. Bottle of 30 NDC # 31722-249-30 Bottle of 90 NDC # 31722-249-90 Bottle of 100 NDC # 31722-249-01 Bottle of 500 NDC # 31722-249-05 Bottle of 1000 NDC # 31722-249-10 10 mg Tablets: white, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 250 on other. Bottle of 30 NDC # 31722-250-30 Bottle of 90 NDC # 31722-250-90 Bottle of 100 NDC # 31722-250-01 Bottle of 500 NDC # 31722-250-05 Bottle of 1000 NDC # 31722-250-10 20 mg Tablets: white, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 251 on other. Bottle of 30 NDC # 31722-251-30 Bottle of 90 NDC # 31722-251-90 Bottle of 100 NDC # 31722-251-01 Bottle of 500 NDC # 31722-251-05 Bottle of 1000 NDC # 31722-251-10 Storage and Handling: Store at 20°C to 25°C (68° F to 77°F). [See USP Controlled Room Temperature. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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