ESCITALOPRAM tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Aidarex Pharmaceuticals LLC

INN（国際名）:

ESCITALOPRAM OXALATE

構図:

ESCITALOPRAM 10 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Escitalopram is 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. Escitalopram is 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 six mo

製品概要:

10 mg Tablets: White, film coated, round, biconvex tablets debossed with I on left side and G on right side of bisect and 250 on other. Storage and Handling: Store at 20°C to 25°C (68° F to 77°F). [See USP Controlled Room Temperature. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ESCITALOPRAM- ESCITALOPRAM TABLET
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
ESCITALOPRAM TABLETS, USP
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ESCITALOPRAM.
ESCITALOPRAM (ESCITALOPRAM) TABLET 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 IS
NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE
(5.1).
INDICATIONS AND USAGE
Escitalopram 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 severe renal
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)
CONTRAINDICATIONS
Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14
days of s