ESCITALOPRAM OXALATE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Macleods Pharmaceuticals Limited

INN (Nama Internasional):

ESCITALOPRAM OXALATE

Komposisi:

ESCITALOPRAM 5 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Escitalopram tablets 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 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 anxiety and worry (apprehensive expectation) that is persistent for at leas

Ringkasan produk:

Tablets 5 mg Tablets: Bottle of 100                       NDC 33342-036-11 Bottle of 500                       NDC 33342-036-15 100 (10 x 10) Unit-Dose Tablets   NDC  33342-036-12 White to off-white, circular, biconvex film coated tablet having ML 59 debossed on one side and plain on other side.. 10 mg Tablets: Bottle of 100                      NDC 33342-037-11 Bottle of 500                      NDC 33342-037-15 100 (10 x 10) Unit Dose Tablets    NDC 33342-037-12 White to off-white, circular, biconvex, film coated tablet having ML 60 debossed on one side, breakline on opposite side and having notches on either ends of breakline. 20 mg Tablets: Bottle of 100               NDC 33342-038-11 Bottle of 500               NDC 33342-038-15 100 (10 x 10) Unit Dose Tablets        NDC 33342-038-12 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. 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].

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

ESCITALOPRAM OXALATE- ESCITALOPRAM OXALATE TABLET, FILM COATED
Macleods Pharmaceuticals Limited
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SPL MEDGUIDE SECTION
Medication Guide
Escitalopram Tablets
(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 tablet
is 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
• oth

Karakteristik produk

ESCITALOPRAM OXALATE - ESCITALOPRAM OXALATE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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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 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).
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 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).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not us