ESCITALOPRAM OXALATE tablet
Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Pakuotės lapelis
(PIL)
29-04-2021
Prekės savybės
(SPC)
29-04-2021
Veiklioji medžiaga:
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Prieinama:
Preferred Pharmaceuticals Inc.
INN (Tarptautinis Pavadinimas):
ESCITALOPRAM OXALATE
Sudėtis:
ESCITALOPRAM 10 mg
Vartojimo būdas:
ORAL
Recepto tipas:
PRESCRIPTION DRUG
Terapinės indikacijos:
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 [ seeClinicalStudies( 14.2) ]. Generalized Anx
Produkto santrauka:
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 28 NDC 68788-6978-8 Bottles of 30 NDC 68788-6978-3 Bottles of 60 NDC 68788-6978-6 Bottles of 90 NDC 68788-6978-9 Bottles of 100 NDC 68788-6978-1 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].
Autorizacija statusas:
Abbreviated New Drug Application
Pakuotės lapelis
ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
Preferred Pharmaceuticals Inc.
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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 changes in behavior or
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Prekės savybės
ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET
PREFERRED PHARMACEUTICALS INC.
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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:
•
•
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
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
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)
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 escital
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