ESCITALOPRAM tablet film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

St. Marys Medical Park Pharmacy

INN (Internationale Bezeichnung):

ESCITALOPRAM OXALATE

Zusammensetzung:

ESCITALOPRAM 10 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
ST. MARYS MEDICAL PARK PHARMACY
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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