Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
St. Marys Medical Park Pharmacy
ESCITALOPRAM OXALATE
ESCITALOPRAM 10 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED ST. MARYS MEDICAL PARK PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESCITALOPRAM OXALATE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM OXALATE. ESCITALOPRAM TABLETS USP FOR ORAL USE 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. ESCITALOPRAM OXALATE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE ( 5.1). RECENT MAJOR CHANGES Warnings and Precautions ( 5.9) 07/2014 INDICATIONS AND USAGE Escitalopram oxalate USP 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) DOSAGE AND ADMINISTRATION Escitalopram tablets 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 severerenal impairment ( 2.3). Discontinuing escitalopram tablets: A gradual dose reduction is recommended ( 2.4). DOSAGE FORMS AND STRENGTHS Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) ( 3.1) CONT Lees het volledige document