escitalopram escitalopram oxalate 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.
apotex corp.
OVAL WHITE APO 4 0
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escitalopram escitalopram oxalate tablet film coated
apotex corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Tablets Escitalopram Tablets, USP 5 mg are available as white, round, biconvex film-coated tablets, engraved “APO” on one side, “ESC” over “5” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2780-3) Bottles of 100 (NDC 60505-2780-1) Bottles of 1,000 (NDC 60505-2780-8) Escitalopram Tablets, USP 10 mg are available as white, round, biconvex film-coated tablets, engraved “APO” on one side, “ESC” over score “10” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2781-3) Bottles of 100 (NDC 60505-2781-1) Bottles of 1,000 (NDC 60505-2781-8) Escitalopram Tablets, USP 20 mg are available as white, round, biconvex film-coated tablets, engraved “APO” on one side, “ESC” over score “20” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-2782-3) Bottles of 100 (NDC 60505-2782-1) Bottles of 1,000 (NDC 60505-2782-8) Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container [see USP].
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