ESCITALOPRAM- escitalopram tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Escitalopram tablets USP 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) ]. Information related to usage of e scitalopram in adolescents is approved for Forest Laboratories, Inc.'s Escitalopram Oxalate Tablets and Oral Solution. However, due to Forest Laboratories, Inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information. 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 attem

Product summary:

Escitalopram Tablets USP, 5 mg are available as white to off-white, round, biconvex, unscored, film-coated tablets, debossed “5850” on one side and “” “5” on the other side. Escitalopram Tablets USP, 10 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5851” on one side and “”, a score, and “10” on the other side.. Escitalopram Tablets USP, 20 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5852” on one side and “”, a score, and “20” on the other side. Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure as required. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDGUIDE
Escitalopram (ES-sye-TAL-oh-pram) Tablets USP
Read the Medication Guide that comes with escitalopram 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?
Escitalopram and other antidepressant medicines may cause serious side
effects, including:
1. Suicidal thoughts or actions:
•
Escitalopram 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 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
•
other unusual changes in behavior or mood
Call your healthcare provider

Summary of Product characteristics

ESCITALOPRAM- ESCITALOPRAM TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESCITALOPRAM TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESCITALOPRAM TABLETS
USP.
INITIAL U.S. APPROVAL: 2002
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 USP 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)
Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
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: A gradual dose reduction is recommended
(2.4).
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3)
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat
psychiatric disorders with escitalopram or within
14 days of stopping treatment with escitalopram. Do not use
escitalopram within 14 days of stopping an MAOI intended
to treat psychiatric disorders. In addition, do not start escitalopram
in a patient who is being treated with linezolid or
intravenous methylene blue (4.1).
Pimozide: Do