Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
NuCarePharmaceuticals, Inc.
ESCITALOPRAM OXALATE
ESCITALOPRAM 20 mg in 2
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
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. Citiți documentul complet
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 ( Citiți documentul complet