Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Escitalopram tablets 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 are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies (
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 70934-060-30 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
ESCITALOPRAM OXALATE- escitalopram oxalate tablet Denton Pharma, Inc. DBA Northwind Pharmaceuticals ---------- Medication Guide Escitalopram (EE sye TAL o pram) Tablets, USP Read the Medication Guide that comes with escitalopram tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about escitalopram tablets? Escitalopram tablets and other antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: • Escitalopram tablets and other antidepressant medicines may increase suicidal thoughts o ractions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • Pay particular attention to such changes when escitalopram tablets are started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual cha Прочитајте комплетан документ
ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- 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 _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN PEDIATRIC AND YOUNG ADULTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( 5.1). ESCITALOPRAM TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE ( 8.4). RECENT MAJOR CHANGES Boxed Warning 08/2020 Dosage and Administration ( 2.3) 08/2020 Warnings and Precautions ( 5.1, 5.5) 08/2020 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 in Adolescents ( 2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Adults ( 2.1) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in 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). DOS Прочитајте комплетан документ