LEXAPRO escitalopram oxalate tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)

Commercializzato da:

Cardinal Health

INN (Nome Internazionale):

ESCITALOPRAM OXALATE

Composizione:

ESCITALOPRAM 10 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

LEXAPRO- ESCITALOPRAM OXALATE TABLET, FILM COATED
CARDINAL HEALTH
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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).
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
Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14
day