ESCITALOPRAM OXALATE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Blenheim Pharmacal, Inc.

DCI (Denominação Comum Internacional):

ESCITALOPRAM OXALATE

Composição:

ESCITALOPRAM 5 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Escitalopram tablets, USP are 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 tablets, USP are 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 persis

Resumo do produto:

Escitalopram tablets, USP 5 mg are white to off-white, round, biconvex, film coated tablets debossed with '135' on one side and '5' on other side. Bottles of 30                                             NDC 10544-224-30 Escitalopram tablets, USP 10 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '36' on one side, and '10' on other side. Bottles of 30                                             NDC 10544-225-30 Escitalopram tablets, USP 20 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '37' on one side, and '20' on other side. Bottles of 30                                             NDC 10544-230-30 Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
BLENHEIM PHARMACAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM TABLETS.
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
TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12
YEARS OF AGE (5.1).
RECENT MAJOR CHANGES
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INDICATIONS AND USAGE
ESCITALOPRAM OXALATE IS A SELECTIVE SEROTONIN REUPTAKE INHIBITOR
(SSRI) INDICATED FOR:
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DOSAGE AND ADMINISTRATION
ESCITALOPRAM TABLETS, USP SHOULD GENERALLY BE ADMINISTERED ONCE DAILY,
MORNING OR EVENING WITH OR WITHOUT FOOD (2.1, 2.2).
INDIC ATIO N
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
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions (5.9) 07/2014
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)
ACUTE TREATMENT OF GENERALIZED ANXIETY DISORDER (GAD) IN ADULTS (1.2)
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 W