Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Blenheim Pharmacal, Inc.
ESCITALOPRAM OXALATE
ESCITALOPRAM 5 mg
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET BLENHEIM PHARMACAL, INC. ---------- 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 • INDICATIONS AND USAGE ESCITALOPRAM OXALATE IS A SELECTIVE SEROTONIN REUPTAKE INHIBITOR (SSRI) INDICATED FOR: • • 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 • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • • • • • 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 Belgenin tamamını okuyun