国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Unit Dose Services
ESCITALOPRAM OXALATE
ESCITALOPRAM 10 mg
PRESCRIPTION DRUG
New Drug Application
LEXAPRO- ESCITALOPRAM OXALATE TABLET, FILM COATED UNIT DOSE SERVICES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEXAPRO® SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEXAPRO® LEXAPRO® (ESCITALOPRAM OXALATE) TABLETS LEXAPRO® (ESCITALOPRAM OXALATE) ORAL SOLUTION INITIAL U.S. APPROVAL: 2002 WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN, ADOLESCENTS AND YOUNG ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. LEXAPRO IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE (5.1). RECENT MAJOR CHANGES Warnings and Precautions (5.2) 01/2017 INDICATIONS AND USAGE Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for: Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1) Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2) DOSAGE AND ADMINISTRATION Lexapro should generally be administered once daily, morning or evening with or without food (2.1, 2.2). Indication Recommended Dose MDD (2.1) Adolescents (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily Adults (2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD (2.2) Adults (2.2) Initial: 10 mg once daily Recommended: 10 mg once daily No additional benefits seen at 20 mg/day dose (2.1). 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment (2.3). No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment (2.3). Discontinuing Lexapro: A gradual dose reduction is recommended (2.4). DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1) Oral solution: 1 mg per mL (3.2) CONTRAINDICATIONS Seroton 阅读完整的文件