Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
REMEDYREPACK INC.
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 (14.2) ]. Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiet
Escitalopram Tablets, USP are available containing escitalopram oxalate, USP equivalent to 5 mg, 10 mg or 20 mg of escitalopram base. The 5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and EC5 on the other side. They are available as follows: NDC 0378-3855-77 bottles of 90 tablets The 10 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M on one side of the tablet and EC above the score and 10 below the score on the other side. They are available as follows: NDC 0378-3856-77 bottles of 90 tablets NDC 0378-3856-10 bottles of 1000 tablets The 20 mg tablets are white to off-white, film-coated, round, scored tablets debossed with M on one side of the tablet and EC above the score and 20 below the score on the other side. They are available as follows: NDC 0378-3857-77 bottles of 90 tablets NDC 0378-3857-10 bottles of 1000 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
New Drug Application Authorized Generic
ESCITALOPRAM OXALATE- ESCITALOPRAM TABLET, FILM COATED REMEDYREPACK INC. ---------- MEDICATION GUIDE Escitalopram Tablets, USP (es″ sye tal′ oh pram) 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 or actions 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 changes in behavior or Perskaitykite visą dokumentą
ESCITALOPRAM OXALATE- ESCITALOPRAM TABLET, FILM COATED REMEDYREPACK 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 TABLETS ARE NOT APPROVED FOR USE IN PEDIATRIC PATIENTS LESS THAN 12 YEARS OF AGE ( 5.1). RECENT MAJOR CHANGES Warnings and Precautions-Serotonin Syndrome (5.2) 10/2016 INDICATIONS AND USAGE Escitalopram tablets are 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 ( 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 (scored) ( 3 Perskaitykite visą dokumentą