ESCITALOPRAM OXALATE- escitalopram oxalate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCarePharmaceuticals, Inc.

INN (International Name):

ESCITALOPRAM OXALATE

Composition:

ESCITALOPRAM 20 mg in 2

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram tablet 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 tablet 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 persist

Product summary:

20 mg Tablets: White to off-white, circular, biconvex, film coated tablet having ML 61 debossed on one side, breakline on opposite side and having notches on either ends of breakline. Bottles of 28 NDC 68071-3283-8 Bottles of 30 NDC 68071-3283-3 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCarePharmaceuticals, Inc.
----------
SPL MEDGUIDE SECTION
.
Revised: 5/2017
Document Id: 5023aab4-7832-4380-e054-00144ff88e88
34391-3
Set id: 5023aab4-7831-4380-e054-00144ff88e88
Version: 1
Effective Time: 20170522
NuCarePharmaceuticals, Inc.

Summary of Product characteristics

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET, FILM COATED
NUCAREPHARMACEUTICALS, 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 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).
RECENT MAJOR CHANGES
• Warnings and Precautions ( 5.2) 01/2017
INDICATIONS AND USAGE
Escitalopram tablet 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
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 (