A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Lexapro Indications, Dosage, Storage, Stability - Escitalopram Oxalate
Lexapro Indications, Dosage, Storage, Stability - Escitalopram Oxalate
INDICATIONS AND USAGE
Major Depressive Disorder
LEXAPRO (escitalopram) is indicated for the treatment of major
depressive disorder.
The efficacy of LEXAPRO in the treatment of major depressive
disorder was established in three, 8-week, placebo-controlled trials of outpatients
whose diagnoses corresponded most closely to the DSM-IV category of major depressive
disorder (see Clinical Pharmacology).
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.
The efficacy of LEXAPRO in hospitalized patients with major
depressive disorders has not been adequately studied.
The efficacy of LEXAPRO in maintaining a response, in patients
with major depressive disorder who responded during an 8-week, acute-treatment
phase while taking LEXAPRO and were then observed for relapse during a period
of up to 36 weeks, was demonstrated in a placebo-controlled trial (see Clinical
Efficacy Trials, under Clinical Pharmacology).
Nevertheless, the physician who elects to use LEXAPRO for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the individual
patient (see Dosage and Administration).
Generalized Anxiety Disorder
LEXAPRO is indicated for the treatment of Generalized Anxiety
Disorder (GAD).
The efficacy of LEXAPRO was established in three, 8-week, placebo-controlled
trials in patients with GAD (see Clinical Pharmacology).
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive
anxiety and worry (apprehensive expectation) that is persistent for at least
6 months and which the person finds difficult to control. It must be associated
with at least 3 of the following symptoms: restlessness or feeling keyed up
or on edge, being easily fatigued, difficulty concentrating or mind going blank,
irritability, muscle tension, and sleep disturbance.
The efficacy of LEXAPRO in the long-term treatment of GAD,
that is, for more than 8 weeks, has not been systematically evaluated in controlled
trials. The physician who elects to use LEXAPRO for extended periods should
periodically re-evaluate the long-term usefulness of the drug for the individual
patient.
DOSAGE AND ADMINISTRATION
Major Depressive Disorder Initial Treatment
The recommended dose of LEXAPRO is 10 mg once daily. A fixed
dose trial of LEXAPRO demonstrated the effectiveness of both 10 mg and 20 mg
of LEXAPRO, but failed to demonstrate a greater benefit of 20 mg over 10 mg
(see Clinical Efficacy Trials under Clinical Pharmacology).
If the dose is increased to 20 mg, this should occur after a minimum of one
week.
LEXAPRO should be administered once daily, in the morning or
evening, with or without food.
Special Populations
10 mg/day is the recommended dose for most elderly patients
and patients with hepatic impairment.
No dosage adjustment is necessary for patients with mild or
moderate renal impairment. LEXAPRO should be used with caution in patients with
severe renal impairment.
Treatment of Pregnant Women During the Third Trimester
Neonates exposed to LEXAPRO and other SSRIs or SNRIs, late
in the third trimester, have developed complications requiring prolonged hospitalization,
respiratory support, and tube feeding (see PRECAUTIONS).
When treating pregnant women with LEXAPRO during the third trimester, the physician
should carefully consider the potential risks and benefits of treatment. The
physician may consider tapering LEXAPRO in the third trimester.
Maintenance Treatment
It is generally agreed that acute episodes of major depressive
disorder require several months or longer of sustained pharmacological therapy
beyond response to the acute episode. Systematic evaluation of continuing LEXAPRO
10 or 20 mg/day for periods of up to 36 weeks in patients with major depressive
disorder who responded while taking LEXAPRO during an 8-week, acute-treatment
phase demonstrated a benefit of such maintenance treatment (see Clinical Efficacy
Trials, under Clinical Pharmacology). Nevertheless,
patients should be periodically reassessed to determine the need for maintenance
treatment.
Generalized Anxiety Disorder Initial Treatment
The recommended starting dose of LEXAPRO is 10 mg once daily.
If the dose is increased to 20 mg, this should occur after a minimum of one
week.
LEXAPRO should be administered once daily, in the morning or
evening, with or without food.
Maintenance Treatment
Generalized anxiety disorder is recognized as a chronic condition.
The efficacy of LEXAPRO in the treatment of GAD beyond 8 weeks has not been
systematically studied. The physician who elects to use LEXAPRO for extended
periods should periodically reevaluate the long-term usefulness of the drug
for the individual patient.
Discontinuation of Treatment with LEXAPRO
Symptoms associated with discontinuation of LEXAPRO and other
SSRIs and SNRIs, have been reported (see PRECAUTIONS).
Patients should be monitored for these symptoms when discontinuing treatment.
A gradual reduction in the dose rather than abrupt cessation is recommended
whenever possible. If intolerable symptoms occur following a decrease in the
dose or upon discontinuation of treatment, then resuming the previously prescribed
dose may be considered. Subsequently, the physician may continue decreasing
the dose but at a more gradual rate.
Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of a
MAOI and initiation of LEXAPRO therapy. Similarly, at least 14 days should be
allowed after stopping LEXAPRO before starting a MAOI (see Contraindications
and Warnings).
HOW SUPPLIED
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5 mg Tablets:
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|
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Bottle of 100
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NDC # 0456-2005-01
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White to off-white, round, non-scored, film-coated. Imprint
"FL" on one side of the tablet and "5" on the other side.
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10 mg Tablets:
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Bottle of 100
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NDC # 0456-2010-01
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10 x 10 Unit Dose
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NDC # 0456-2010-63
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White to off-white, round, scored, film-coated. Imprint
on scored side with "F" on the left side and "L" on the right side.
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Imprint on the non-scored side with "10".
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20 mg Tablets:
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Bottle of 100
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NDC # 0456-2020-01
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|
10 x 10 Unit Dose
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NDC # 0456-2020-63
|
|
White to off-white, round, scored, film-coated. Imprint
on scored side with "F" on the left side and "L" on the right side.
|
|
Imprint on the non-scored side with "20".
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Oral Solution:
5 mg/5 mL, peppermint flavor (240 mL) NDC # 0456-2101-08
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).
ANIMAL TOXICOLOGY
Retinal Changes in Rats
Pathologic changes (degeneration/atrophy) were observed in
the retinas of albino rats in the 2-year carcinogenicity study with racemic
citalopram. There was an increase in both incidence and severity of retinal
pathology in both male and female rats receiving 80 mg/kg/day. Similar findings
were not present in rats receiving 24 mg/kg/day of racemic citalopram for two
years, in mice receiving up to 240 mg/kg/day of racemic citalopram for 18 months,
or in dogs receiving up to 20 mg/kg/day of racemic citalopram for one year.
Additional studies to investigate the mechanism for this pathology
have not been performed, and the potential significance of this effect in humans
has not been established.
Cardiovascular Changes in Dogs
In a one year toxicology study, 5 of 10 beagle dogs receiving
oral racemic citalopram doses of 8 mg/kg/day died suddenly between weeks 17
and 31 following initiation of treatment. Sudden deaths were not observed in
rats at doses of racemic citalopram up to 120 mg/kg/day, which produced plasma
levels of citalopram and its metabolites demethylcitalopram and didemethylcitalopram
(DDCT) similar to those observed in dogs at 8 mg/kg/day. A subsequent intravenous
dosing study demonstrated that in beagle dogs, racemic DDCT caused QT prolongation,
a known risk factor for the observed outcome in dogs.
Forest Pharmaceuticals, Inc. Subsidiary of
Forest Laboratories, Inc. St. Louis, MO 63045 USA Licensed from H. Lundbeck
A/S, Rev. 12/03 © 2003 Forest Laboratories, Inc. MG #17541(04)
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