Lexapro Information
Lexapro (Escitalopram oxalate)
Lexapro (Escitalopram oxalate)
Lexapro (Escitalopram oxalate) Indications And Usage
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.
Lexapro (Escitalopram oxalate) is indicated for the acute treatment of Generalized
Anxiety Disorder (GAD) in adults [].
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.
Lexapro (Escitalopram oxalate) Dosage And Administration
Lexapro (Escitalopram oxalate) should be administered once daily, in the morning or
evening, with or without food.
The recommended dose of Lexapro (Escitalopram oxalate) is 10 mg once daily. A fixed-dose trial of
Lexapro (Escitalopram oxalate) demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro (Escitalopram oxalate) , but
failed to demonstrate a greater benefit of 20 mg over 10 mg []. If the
dose is increased to 20 mg, this should occur after a minimum of one week.
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 (Escitalopram oxalate) 10 or
20 mg/day in adults patients with major depressive disorder who responded while
taking Lexapro (Escitalopram oxalate) during an 8-week, acute-treatment phase demonstrated a benefit of
such maintenance treatment [see Clinical Studies ()].
Nevertheless, the physician who elects to use Lexapro (Escitalopram oxalate) for extended periods
should periodically re-evaluate the long-term usefulness of the drug for the
individual patient. Patients should be periodically reassessed to determine the
need for maintenance treatment.
The recommended starting dose of Lexapro (Escitalopram oxalate) is 10 mg once daily. If the dose is
increased to 20 mg, this should occur after a minimum of one week.
Generalized anxiety disorder is recognized as a chronic condition. The
efficacy of Lexapro (Escitalopram oxalate) in the treatment of GAD beyond 8 weeks has not been
systematically studied. The physician who elects to use Lexapro (Escitalopram oxalate) for extended
periods should periodically re-evaluate the long-term usefulness of the drug for
the individual patient.
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 (Escitalopram oxalate) should be used with caution in patients with severe renal
impairment.
Symptoms associated with discontinuation of Lexapro (Escitalopram oxalate) and other
SSRIs and SNRIs have been reported []. 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.
At least 14 days should elapse between discontinuation of an MAOI
and initiation of Lexapro (Escitalopram oxalate) therapy. Similarly, at least 14 days should be allowed
after stopping Lexapro (Escitalopram oxalate) before starting an MAOI [].
Lexapro (Escitalopram oxalate) Dosage Forms And Strengths
Lexapro (Escitalopram oxalate) tablets are film-coated, round tablets containing
escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg
escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with "FL" on
one side and either "5", “10”, or “20” on the other side according to their
respective strengths.
Lexapro (Escitalopram oxalate) oral solution contains escitalopram oxalate equivalent to
1 mg/mL escitalopram base.
Lexapro (Escitalopram oxalate) Contraindications
Concomitant use in patients taking monoamine oxidase inhibitors
(MAOIs) is contraindicated [].
Concomitant use in patients taking pimozide is contraindicated
[].
Lexapro (Escitalopram oxalate) is contraindicated in patients with a hypersensitivity to
escitalopram or citalopram or any of the inactive ingredients in Lexapro (Escitalopram oxalate) .
Lexapro (Escitalopram oxalate) Warnings And Precautions
Patients with major depressive disorder (MDD), both adult and
pediatric, may experience worsening of their depression and/or the emergence of
suicidal ideation and behavior (suicidality) or unusual changes in behavior,
whether or not they are taking antidepressant medications, and this risk may
persist until significant remission occurs. Suicide is a known risk of
depression and certain other psychiatric disorders, and these disorders
themselves are the strongest predictors of suicide. There has been a
long-standing concern, however, that antidepressants may have a role in inducing
worsening of depression and the emergence of suicidality in certain patients
during the early phases of treatment. Pooled analyses of short-term
placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that
these drugs increase the risk of suicidal thinking and behavior (suicidality) in
children, adolescents, and young adults (ages 18-24) with major depressive
disorder (MDD) and other psychiatric disorders. Short-term studies did not show
an increase in the risk of suicidality with antidepressants compared to placebo
in adults beyond age 24; there was a reduction with antidepressants compared to
placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents
with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders
included a total of 24 short-term trials of 9 antidepressant drugs in over 4400
patients. The pooled analyses of placebo-controlled trials in adults with MDD or
other psychiatric disorders included a total of 295 short-term trials (median
duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There
was considerable variation in risk of suicidality among drugs, but a tendency
toward an increase in the younger patients for almost all drugs studied. There
were differences in absolute risk of suicidality across the different
indications, with the highest incidence in MDD. The risk differences (drug vs.
placebo), however, were relatively stable within age strata and across
indications. These risk differences (drug-placebo difference in the number of
cases of suicidality per 1000 patients treated) are provided in
No suicides occurred in any of the pediatric trials. There were suicides in
the adult trials, but the number was not sufficient to reach any conclusion
about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e.,
beyond several months. However, there is substantial evidence from
placebo-controlled maintenance trials in adults with depression that the use of
antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be
monitored appropriately and observed closely for clinical worsening,
suicidality, and unusual changes in behavior, especially during the initial few
months of a course of drug therapy, or at times of dose changes, either
increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia,
irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, and mania, have been reported in adult and pediatric
patients being treated with antidepressants for major depressive disorder as
well as for other indications, both psychiatric and nonpsychiatric. Although a
causal link between the emergence of such symptoms and either the worsening of
depression and/or the emergence of suicidal impulses has not been established,
there is concern that such symptoms may represent precursors to emerging
suicidality.
Consideration should be given to changing the therapeutic regimen, including
possibly discontinuing the medication, in patients whose depression is
persistently worse, or who are experiencing emergent suicidality or symptoms
that might be precursors to worsening depression or suicidality, especially if
these symptoms are severe, abrupt in onset, or were not part of the patient's
presenting symptoms.
If the decision has been made to discontinue treatment, medication should be
tapered, as rapidly as is feasible, but with recognition that abrupt
discontinuation can be associated with certain symptoms [].
Families and caregivers of patients being treated with antidepressants for
major depressive disorder or other indications, both psychiatric and
nonpsychiatric, should be alerted about the need to monitor patients for the
emergence of agitation, irritability, unusual changes in behavior, and the other
symptoms described above, as well as the emergence of suicidality, and to report
such symptoms immediately to health care providers. Such monitoring should
include daily observation by families and caregivers [].
Prescriptions for Lexapro (Escitalopram oxalate) should be written for the smallest quantity of tablets
consistent with good patient management, in order to reduce the risk of
overdose.
A major depressive episode may be the initial presentation of bipolar
disorder. It is generally believed (though not established in controlled trials)
that treating such an episode with an antidepressant alone may increase the
likelihood of precipitation of a mixed/manic episode in patients at risk for
bipolar disorder. Whether any of the symptoms described above represent such a
conversion is unknown. However, prior to initiating treatment with an
antidepressant, patients with depressive symptoms should be adequately screened
to determine if they are at risk for bipolar disorder; such screening should
include a detailed psychiatric history, including a family history of suicide,
bipolar disorder, and depression. It should be noted that Lexapro (Escitalopram oxalate) is not
approved for use in treating bipolar depression.
The concomitant use of Lexapro (Escitalopram oxalate) with MAOIs intended to treat depression is
contraindicated. If concomitant treatment of Lexapro (Escitalopram oxalate) with a 5-hydroxytryptamine
receptor agonist (triptan) is clinically warranted, careful observation of the
patient is advised, particularly during treatment initiation and dose
increases.
The concomitant use of Lexapro (Escitalopram oxalate) with serotonin precursors (such as tryptophan)
is not recommended. Treatment with Lexapro (Escitalopram oxalate) and any concomitant serotonergic or
antidopaminergic agents, including antipsychotics, should be discontinued
immediately if the above events occur and supportive symptomatic treatment
should be initiated.
During marketing of Lexapro (Escitalopram oxalate) and other SSRIs and SNRIs (serotonin
and norepinephrine reuptake inhibitors), there have been spontaneous reports of
adverse events occurring upon discontinuation of these drugs, particularly when
abrupt, including the following: dysphoric mood, irritability, agitation,
dizziness, sensory disturbances (e.g., paresthesias such as electric shock
sensations), anxiety, confusion, headache, lethargy, emotional lability,
insomnia, and hypomania. While these events are generally self-limiting, there
have been reports of serious discontinuation symptoms.
Patients should be monitored for these symptoms when discontinuing treatment
with Lexapro (Escitalopram oxalate) . 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 [].
Although anticonvulsant effects of racemic citalopram have been
observed in animal studies, Lexapro (Escitalopram oxalate) has not been systematically evaluated in
patients with a seizure disorder. These patients were excluded from clinical
studies during the product's premarketing testing. In clinical trials of
Lexapro (Escitalopram oxalate) , cases of convulsion have been reported in association with Lexapro (Escitalopram oxalate)
treatment. Like other drugs effective in the treatment of major depressive
disorder, Lexapro (Escitalopram oxalate) should be introduced with care in patients with a history of
seizure disorder.
In placebo-controlled trials of Lexapro (Escitalopram oxalate) in major depressive
disorder, activation of mania/hypomania was reported in one (0.1%) of 715
patients treated with Lexapro (Escitalopram oxalate) and in none of the 592 patients treated with
placebo. One additional case of hypomania has been reported in association with
Lexapro (Escitalopram oxalate) treatment. Activation of mania/hypomania has also been reported in a
small proportion of patients with major affective disorders treated with racemic
citalopram and other marketed drugs effective in the treatment of major
depressive disorder. As with all drugs effective in the treatment of major
depressive disorder, Lexapro (Escitalopram oxalate) should be used cautiously in patients with a
history of mania.
Patients should be cautioned about the risk of bleeding associated with the
concomitant use of Lexapro (Escitalopram oxalate) and NSAIDs, aspirin, or other drugs that affect
coagulation.
In a study in normal volunteers, Lexapro (Escitalopram oxalate) 10 mg/day did not
produce impairment of intellectual function or psychomotor performance. Because
any psychoactive drug may impair judgment, thinking, or motor skills, however,
patients should be cautioned about operating hazardous machinery, including
automobiles, until they are reasonably certain that Lexapro (Escitalopram oxalate) therapy does not
affect their ability to engage in such activities.
Clinical experience with Lexapro (Escitalopram oxalate) in patients with certain
concomitant systemic illnesses is limited. Caution is advisable in using Lexapro (Escitalopram oxalate)
in patients with diseases or conditions that produce altered metabolism or
hemodynamic responses.
Lexapro (Escitalopram oxalate) has not been systematically evaluated in patients with a recent
history of myocardial infarction or unstable heart disease. Patients with these
diagnoses were generally excluded from clinical studies during the product's
premarketing testing.
In subjects with hepatic impairment, clearance of racemic citalopram was
decreased and plasma concentrations were increased. The recommended dose of
Lexapro (Escitalopram oxalate) in hepatically impaired patients is 10 mg/day [].
Because escitalopram is extensively metabolized, excretion of unchanged drug
in urine is a minor route of elimination. Until adequate numbers of patients
with severe renal impairment have been evaluated during chronic treatment with
Lexapro (Escitalopram oxalate) , however, it should be used with caution in such patients [].
In patients receiving serotonin reuptake inhibitor drugs in
combination with a monoamine oxidase inhibitor (MAOI), there have been reports
of serious, sometimes fatal, reactions including hyperthermia, rigidity,
myoclonus, autonomic instability with possible rapid fluctuations of vital
signs, and mental status changes that include extreme agitation progressing to
delirium and coma. These reactions have also been reported in patients who have
recently discontinued SSRI treatment and have been started on an MAOI. Some
cases presented with features resembling neuroleptic malignant syndrome.
Furthermore, limited animal data on the effects of combined use of SSRIs and
MAOIs suggest that these drugs may act synergistically to elevate blood pressure
and evoke behavioral excitation. Therefore, it is recommended that Lexapro (Escitalopram oxalate)
should not be used in combination with an MAOI, or within 14 days of
discontinuing treatment with an MAOI. Similarly, at least 14 days should be
allowed after stopping Lexapro (Escitalopram oxalate) before starting an MAOI.
Serotonin syndrome has been reported in two patients who were concomitantly
receiving linezolid, an antibiotic which is a reversible non-selective MAOI.
Lexapro (Escitalopram oxalate) Adverse Reactions
Because clinical studies are conducted under widely varying
conditions, adverse reaction rates observed in the clinical studies of a drug
cannot be directly compared to rates in the clinical studies of another drug and
may not reflect the rates observed in practice.
Adverse events were collected in 576 pediatric patients (286 Lexapro (Escitalopram oxalate) , 290
placebo) with major depressive disorder in double-blind placebo-controlled
studies. Safety and effectiveness of Lexapro (Escitalopram oxalate) in pediatric patients less than 12
years of age has not been established.
Adverse events information for Lexapro (Escitalopram oxalate) was collected from 715 patients with
major depressive disorder who were exposed to escitalopram and from 592 patients
who were exposed to placebo in double-blind, placebo-controlled trials. An
additional 284 patients with major depressive disorder were newly exposed to
escitalopram in open-label trials. The adverse event information for Lexapro (Escitalopram oxalate) in
patients with GAD was collected from 429 patients exposed to escitalopram and
from 427 patients exposed to placebo in double-blind, placebo-controlled
trials.
Adverse events during exposure were obtained primarily by general inquiry and
recorded by clinical investigators using terminology of their own choosing.
Consequently, it is not possible to provide a meaningful estimate of the
proportion of individuals experiencing adverse events without first grouping
similar types of events into a smaller number of standardized event categories.
In the tables and tabulations that follow, standard World Health Organization
(WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse reactions represent the proportion of
individuals who experienced, at least once, a treatment-emergent adverse event
of the type listed. An event was considered treatment-emergent if it occurred
for the first time or worsened while receiving therapy following baseline
evaluation.
Adverse events were associated with discontinuation of 3.5% of 286 patients
receiving Lexapro (Escitalopram oxalate) and 1% of 290 patients receiving placebo. The most common
adverse event (incidence at least 1% for Lexapro (Escitalopram oxalate) and greater than placebo)
associated with discontinuation was insomnia (1% Lexapro (Escitalopram oxalate) , 0% placebo).
Among the 715 depressed patients who received Lexapro (Escitalopram oxalate) in placebo-controlled
trials, 6% discontinued treatment due to an adverse event, as compared to 2% of
592 patients receiving placebo. In two fixed-dose studies, the rate of
discontinuation for adverse events in patients receiving 10 mg/day Lexapro (Escitalopram oxalate) was
not significantly different from the rate of discontinuation for adverse events
in patients receiving placebo. The rate of discontinuation for adverse events in
patients assigned to a fixed dose of 20 mg/day Lexapro (Escitalopram oxalate) was 10%, which was
significantly different from the rate of discontinuation for adverse events in
patients receiving 10 mg/day Lexapro (Escitalopram oxalate) (4%) and placebo (3%). Adverse events that
were associated with the discontinuation of at least 1% of patients treated with
Lexapro (Escitalopram oxalate) , and for which the rate was at least twice that of placebo, were nausea
(2%) and ejaculation disorder (2% of male patients).
Among the 429 GAD patients who received Lexapro (Escitalopram oxalate) 10-20 mg/day in
placebo-controlled trials, 8% discontinued treatment due to an adverse event, as
compared to 4% of 427 patients receiving placebo. Adverse events that were
associated with the discontinuation of at least 1% of patients treated with
Lexapro (Escitalopram oxalate) , and for which the rate was at least twice the placebo rate, were nausea
(2%), insomnia (1%), and fatigue (1%).
The overall profile of adverse reactions in pediatric patients was generally
similar to that seen in adult studies, as shown in .
However, the following adverse reactions (excluding those which appear in and those for which the coded terms were uninformative or
misleading) were reported at an incidence of at least 2% for Lexapro (Escitalopram oxalate) and greater
than placebo: back pain, urinary tract infection, vomiting, and nasal
congestion.
The most commonly observed adverse reactions in Lexapro (Escitalopram oxalate) patients (incidence
of approximately 5% or greater and approximately twice the incidence in placebo
patients) were insomnia, ejaculation disorder (primarily ejaculatory delay),
nausea, sweating increased, fatigue, and somnolence.
The most commonly observed adverse reactions in Lexapro (Escitalopram oxalate) patients (incidence
of approximately 5% or greater and approximately twice the incidence in placebo
patients) were nausea, ejaculation disorder (primarily ejaculatory delay),
insomnia, fatigue, decreased libido, and anorgasmia.
Lexapro (Escitalopram oxalate)
Lexapro (Escitalopram oxalate) Drug Interactions
Based on the mechanism of action of SNRIs and SSRIs including
Lexapro (Escitalopram oxalate) , and the potential for serotonin syndrome, caution is advised when
Lexapro (Escitalopram oxalate) is coadministered with other drugs that may affect the serotonergic
neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a
reversible non-selective MAOI), lithium, tramadol, or St. John's Wort []. The
concomitant use of Lexapro (Escitalopram oxalate) with other SSRIs, SNRIs or tryptophan is not
recommended.
There have been rare postmarketing reports of serotonin syndrome
with use of an SSRI and a triptan. If concomitant treatment of Lexapro (Escitalopram oxalate) with a
triptan is clinically warranted, careful observation of the patient is advised,
particularly during treatment initiation and dose increases [].
Given the primary CNS effects of escitalopram, caution should be
used when it is taken in combination with other centrally acting drugs.
Although Lexapro (Escitalopram oxalate) did not potentiate the cognitive and motor
effects of alcohol in a clinical trial, as with other psychotropic medications,
the use of alcohol by patients taking Lexapro (Escitalopram oxalate) is not recommended.
Serotonin release by platelets plays an important role in
hemostasis. Epidemiological studies of the case-control and cohort design that
have demonstrated an association between use of psychotropic drugs that
interfere with serotonin reuptake and the occurrence of upper gastrointestinal
bleeding have also shown that concurrent use of an NSAID or aspirin may
potentiate the risk of bleeding. Altered anticoagulant effects, including
increased bleeding, have been reported when SSRIs and SNRIs are coadministered
with warfarin. Patients receiving warfarin therapy should be carefully monitored
when Lexapro (Escitalopram oxalate) is initiated or discontinued.
In subjects who had received 21 days of 40 mg/day racemic
citalopram, combined administration of 400 mg/day cimetidine for 8 days resulted
in an increase in citalopram AUC and C of 43% and 39%,
respectively. The clinical significance of these findings is unknown.
In subjects who had received 21 days of 40 mg/day racemic
citalopram, combined administration of citalopram and digoxin (single dose of 1
mg) did not significantly affect the pharmacokinetics of either citalopram or
digoxin.
Coadministration of racemic citalopram (40 mg/day for 10 days)
and lithium (30 mmol/day for 5 days) had no significant effect on the
pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels
should be monitored with appropriate adjustment to the lithium dose in
accordance with standard clinical practice. Because lithium may enhance the
serotonergic effects of escitalopram, caution should be exercised when Lexapro (Escitalopram oxalate)
and lithium are coadministered.
In a controlled study, a single dose of pimozide 2 mg
co-administered with racemic citalopram 40 mg given once daily for 11 days was
associated with a mean increase in QTc values of approximately 10 msec compared
to pimozide given alone. Racemic citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic
interaction is not known.
There have been rare postmarketing reports describing patients
with weakness, hyperreflexia, and incoordination following the use of an SSRI
and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g.,
fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is
clinically warranted, appropriate observation of the patient is advised.
Combined administration of racemic citalopram (40 mg/day for 21
days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not
affect the pharmacokinetics of theophylline. The effect of theophylline on the
pharmacokinetics of citalopram was not evaluated.
Administration of 40 mg/day racemic citalopram for 21 days did
not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin
time was increased by 5%, the clinical significance of which is unknown.
Combined administration of racemic citalopram (40 mg/day for 14
days) and carbamazepine (titrated to 400 mg/day for 35 days) did not
significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate.
Although trough citalopram plasma levels were unaffected, given the
enzyme-inducing properties of carbamazepine, the possibility that carbamazepine
might increase the clearance of escitalopram should be considered if the two
drugs are coadministered.
Combined administration of racemic citalopram (titrated to 40
mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg)
did not significantly affect the pharmacokinetics of either citalopram or
triazolam.
Combined administration of racemic citalopram (40 mg) and
ketoconazole (200 mg), a potent CYP3A4 inhibitor, decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and
did not significantly affect the pharmacokinetics of citalopram.
Combined administration of a single dose of ritonavir (600 mg),
both a CYP3A4 substrate and a potent inhibitor of CYP3A4, and escitalopram (20
mg) did not affect the pharmacokinetics of either ritonavir or
escitalopram.
Administration of 20 mg/day Lexapro (Escitalopram oxalate) for 21 days in healthy
volunteers resulted in a 50% increase in C and 82%
increase in AUC of the beta-adrenergic blocker metoprolol (given in a single
dose of 100 mg). Increased metoprolol plasma levels have been associated with
decreased cardioselectivity. Coadministration of Lexapro (Escitalopram oxalate) and metoprolol had no
clinically significant effects on blood pressure or heart rate.
There are no clinical studies of the combined use of ECT and
escitalopram.
Lexapro (Escitalopram oxalate) Use In Specific Populations
Pregnancy Category C
In a rat embryo/fetal development study, oral administration of escitalopram
(56, 112, or 150 mg/kg/day) to pregnant animals during the period of
organogenesis resulted in decreased fetal body weight and associated delays in
ossification at the two higher doses (approximately greater than or equal to 56 times the maximum
recommended human dose [MRHD] of 20 mg/day on a body surface area [mg/m] basis). Maternal toxicity (clinical signs and decreased body
weight gain and food consumption), mild at 56 mg/kg/day, was present at all dose
levels. The developmental no-effect dose of 56 mg/kg/day is approximately 28
times the MRHD on a mg/m basis. No teratogenicity was
observed at any of the doses tested (as high as 75 times the MRHD on a mg/m basis).
When female rats were treated with escitalopram (6, 12, 24, or 48 mg/kg/day)
during pregnancy and through weaning, slightly increased offspring mortality and
growth retardation were noted at 48 mg/kg/day which is approximately 24 times
the MRHD on a mg/m basis. Slight maternal toxicity
(clinical signs and decreased body weight gain and food consumption) was seen at
this dose. Slightly increased offspring mortality was also seen at 24 mg/kg/day.
The no-effect dose was 12 mg/kg/day which is approximately 6 times the MRHD on a
mg/m basis.
In animal reproduction studies, racemic citalopram has been shown to have
adverse effects on embryo/fetal and postnatal development, including teratogenic
effects, when administered at doses greater than human therapeutic doses.
In two rat embryo/fetal development studies, oral administration of racemic
citalopram (32, 56, or 112 mg/kg/day) to pregnant animals during the period of
organogenesis resulted in decreased embryo/fetal growth and survival and an
increased incidence of fetal abnormalities (including cardiovascular and
skeletal defects) at the high dose. This dose was also associated with maternal
toxicity (clinical signs, decreased body weight gain). The developmental
no-effect dose was 56 mg/kg/day. In a rabbit study, no adverse effects on
embryo/fetal development were observed at doses of racemic citalopram of up to
16 mg/kg/day. Thus, teratogenic effects of racemic citalopram were observed at a
maternally toxic dose in the rat and were not observed in the rabbit.
When female rats were treated with racemic citalopram (4.8, 12.8, or 32
mg/kg/day) from late gestation through weaning, increased offspring mortality
during the first 4 days after birth and persistent offspring growth retardation
were observed at the highest dose. The no-effect dose was 12.8 mg/kg/day.
Similar effects on offspring mortality and growth were seen when dams were
treated throughout gestation and early lactation at doses greater than or equal to 24 mg/kg/day. A
no-effect dose was not determined in that study.
There are no adequate and well-controlled studies in pregnant women;
therefore, escitalopram should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Pregnancy-Nonteratogenic Effects
Neonates exposed to Lexapro (Escitalopram oxalate) and other SSRIs or SNRIs, late in the third
trimester, have developed complications requiring prolonged hospitalization,
respiratory support, and tube feeding. Such complications can arise immediately
upon delivery. Reported clinical findings have included respiratory distress,
cyanosis, apnea, seizures, temperature instability, feeding difficulty,
vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor,
jitteriness, irritability, and constant crying. These features are consistent
with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug
discontinuation syndrome. It should be noted that, in some cases, the clinical
picture is consistent with serotonin syndrome [].
Infants exposed to SSRIs in late pregnancy may have an increased risk for
persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1—2 per
1000 live births in the general population and is associated with substantial
neonatal morbidity and mortality. In a retrospective, case-control study of 377
women whose infants were born with PPHN and 836 women whose infants were born
healthy, the risk for developing PPHN was approximately six-fold higher for
infants exposed to SSRIs after the 20th week of gestation compared to infants
who had not been exposed to antidepressants during pregnancy. There is currently
no corroborative evidence regarding the risk for PPHN following exposure to
SSRIs in pregnancy; this is the first study that has investigated the potential
risk. The study did not include enough cases with exposure to individual SSRIs
to determine if all SSRIs posed similar levels of PPHN risk.
When treating a pregnant woman with Lexapro (Escitalopram oxalate) during the third trimester, the
physician should carefully consider both the potential risks and benefits of
treatment []. Physicians should note that in a prospective
longitudinal study of 201 women with a history of major depression who were
euthymic at the beginning of pregnancy, women who discontinued antidepressant
medication during pregnancy were more likely to experience a relapse of major
depression than women who continued antidepressant medication.
The effect of Lexapro (Escitalopram oxalate) on labor and delivery in humans is
unknown.
Escitalopram is excreted in human breast milk. Limited data from
women taking 10-20 mg escitalopram showed that exclusively breast-fed infants
receive approximately 3.9% of the maternal weight-adjusted dose of escitalopram
and 1.7% of the maternal weight-adjusted dose of desmethylcitalopram. There were
two reports of infants experiencing excessive somnolence, decreased feeding, and
weight loss in association with breastfeeding from a racemic citalopram-treated
mother; in one case, the infant was reported to recover completely upon
discontinuation of racemic citalopram by its mother and, in the second case, no
follow-up information was available. Caution should be exercised and
breastfeeding infants should be observed for adverse reactions when Lexapro (Escitalopram oxalate) is
administered to a nursing woman.
Safety and effectiveness of Lexapro (Escitalopram oxalate) has not been established in
pediatric patients (less than 12 years of age) with Major Depressive Disorder.
Safety and effectiveness of Lexapro (Escitalopram oxalate) has been established in adolescents (12 to
17 years of age) for the treatment of major depressive disorder []. Although
maintenance efficacy in adolescent patients with Major Depressive Disorder has
not been systematically evaluated, maintenance efficacy can be extrapolated from
adult data along with comparisons of escitalopram pharmacokinetic parameters in
adults and adolescent patients.
Safety and effectiveness of Lexapro (Escitalopram oxalate) has not been established in pediatric
patients less than 18 years of age with Generalized Anxiety Disorder.
Approximately 6% of the 1144 patients receiving escitalopram in
controlled trials of Lexapro (Escitalopram oxalate) in major depressive disorder and GAD were 60 years
of age or older; elderly patients in these trials received daily doses of
Lexapro (Escitalopram oxalate) between 10 and 20 mg. The number of elderly patients in these trials was
insufficient to adequately assess for possible differential efficacy and safety
measures on the basis of age. Nevertheless, greater sensitivity of some elderly
individuals to effects of Lexapro (Escitalopram oxalate) cannot be ruled out.
SSRIs and SNRIs, including Lexapro (Escitalopram oxalate) , have been associated with cases of
clinically significant hyponatremia in elderly patients, who may be at greater
risk for this adverse event [see ].
In two pharmacokinetic studies, escitalopram half-life was increased by
approximately 50% in elderly subjects as compared to young subjects and C was unchanged []. 10 mg/day is the recommended
dose for elderly patients [].
Of 4422 patients in clinical studies of racemic citalopram, 1357 were 60 and
over, 1034 were 65 and over, and 457 were 75 and over. No overall differences in
safety or effectiveness were observed between these subjects and younger
subjects, and other reported clinical experience has not identified differences
in responses between the elderly and younger patients, but again, greater
sensitivity of some elderly individuals cannot be ruled out.
Lexapro (Escitalopram oxalate) Drug Abuse And Dependence
9.2 Abuse and Dependence
Physical and Psychological Dependence
Animal studies suggest that the abuse liability of racemic citalopram is low.
Lexapro (Escitalopram oxalate) has not been systematically studied in humans for its potential for
abuse, tolerance, or physical dependence. The premarketing clinical experience
with Lexapro (Escitalopram oxalate) did not reveal any drug-seeking behavior. However, these
observations were not systematic and it is not possible to predict on the basis
of this limited experience the extent to which a CNS-active drug will be
misused, diverted, and/or abused once marketed. Consequently, physicians should
carefully evaluate Lexapro (Escitalopram oxalate) patients for history of drug abuse and follow such
patients closely, observing them for signs of misuse or abuse (e.g., development
of tolerance, incrementations of dose, drug-seeking behavior).
Lexapro (Escitalopram oxalate) Overdosage
10.1 Human Experience
In clinical trials of escitalopram, there were reports of
escitalopram overdose, including overdoses of up to 600 mg, with no associated
fatalities. During the postmarketing evaluation of escitalopram, Lexapro (Escitalopram oxalate)
overdoses involving overdoses of over 1000 mg have been reported. As with other
SSRIs, a fatal outcome in a patient who has taken an overdose of escitalopram
has been rarely reported.
Symptoms most often accompanying escitalopram overdose, alone or in
combination with other drugs and/or alcohol, included convulsions, coma,
dizziness, hypotension, insomnia, nausea, vomiting, sinus tachycardia,
somnolence, and ECG changes (including QT prolongation and very rare cases of
torsade de pointes). Acute renal failure has been very rarely reported
accompanying overdose.
Establish and maintain an airway to ensure adequate ventilation
and oxygenation. Gastric evacuation by lavage and use of activated charcoal
should be considered. Careful observation and cardiac and vital sign monitoring
are recommended, along with general symptomatic and supportive care. Due to the
large volume of distribution of escitalopram, forced diuresis, dialysis,
hemoperfusion, and exchange transfusion are unlikely to be of benefit. There are
no specific antidotes for Lexapro (Escitalopram oxalate) .
In managing overdosage, consider the possibility of multiple-drug
involvement. The physician should consider contacting a poison control center
for additional information on the treatment of any overdose.
Lexapro (Escitalopram oxalate) Description
Lexapro (Escitalopram oxalate) ® (escitalopram oxalate) is an orally administered selective serotonin
reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer)
of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is
designated S-(+)-1-[3-(dimethyl-amino)propyl]-1-(-fluorophenyl)-5-phthalancarbonitrile oxalate with the
following structural formula:
The molecular formula is CHFN • CHO and the molecular weight is
414.40.
Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is
freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic
saline solution, sparingly soluble in water and ethanol, slightly soluble in
ethyl acetate, and insoluble in heptane.
Lexapro (Escitalopram oxalate) is available as tablets or as an oral
solution.
Lexapro (Escitalopram oxalate) tablets are film-coated, round tablets containing escitalopram
oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The
10 and 20 mg tablets are scored. The tablets also contain the following inactive
ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal
silicon dioxide, and magnesium stearate. The film coating contains hypromellose,
titanium dioxide, and polyethylene glycol.
Lexapro (Escitalopram oxalate) oral solution contains escitalopram oxalate equivalent to 1 mg/mL
escitalopram base. It also contains the following inactive ingredients:
sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin,
propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.
Lexapro (Escitalopram oxalate) Clinical Pharmacology
The mechanism of antidepressant action of escitalopram, the
S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of
serotonergic activity in the central nervous system (CNS) resulting from its
inhibition of CNS neuronal reuptake of serotonin (5-HT).
The single- and multiple-dose pharmacokinetics of escitalopram
are linear and dose-proportional in a dose range of 10 to 30 mg/day.
Biotransformation of escitalopram is mainly hepatic, with a mean terminal
half-life of about 27-32 hours. With once-daily dosing, steady state plasma
concentrations are achieved within approximately one week. At steady state, the
extent of accumulation of escitalopram in plasma in young healthy subjects was
2.2-2.5 times the plasma concentrations observed after a single dose. The tablet
and the oral solution dosage forms of escitalopram oxalate are
bioequivalent.
Absorption and Distribution
Following a single oral dose (20 mg tablet or solution) of escitalopram, peak
blood levels occur at about 5 hours. Absorption of escitalopram is not affected
by food.
The absolute bioavailability of citalopram is about 80% relative to an
intravenous dose, and the volume of distribution of citalopram is about 12 L/kg.
Data specific on escitalopram are unavailable.
The binding of escitalopram to human plasma proteins is approximately
56%.
Metabolism and Elimination
Following oral administrations of escitalopram, the fraction of drug
recovered in the urine as escitalopram and S-demethylcitalopram (S-DCT) is about
8% and 10%, respectively. The oral clearance of escitalopram is 600 mL/min, with
approximately 7% of that due to renal clearance.
Escitalopram is metabolized to S-DCT and S-didemethylcitalopram (S-DDCT). In
humans, unchanged escitalopram is the predominant compound in plasma. At steady
state, the concentration of the escitalopram metabolite S-DCT in plasma is
approximately one-third that of escitalopram. The level of S-DDCT was not
detectable in most subjects. studies show
that escitalopram is at least 7 and 27 times more potent than S-DCT and S-DDCT,
respectively, in the inhibition of serotonin reuptake, suggesting that the
metabolites of escitalopram do not contribute significantly to the
antidepressant actions of escitalopram. S-DCT and S-DDCT also have no or very
low affinity for serotonergic (5-HT) or other
receptors including alpha- and beta-adrenergic, dopamine (D), histamine (H), muscarinic
(M), and benzodiazepine receptors. S-DCT and S-DDCT
also do not bind to various ion channels including Na,
K, Cl, and Ca channels.
Population Subgroups
Adolescents - In a single dose study of 10 mg escitalopram, AUC
of escitalopram decreased by 19%, and C increased by
26% in healthy adolescent subjects (12 to 17 years of age) compared to adults.
Following multiple dosing of 40 mg/day citalopram, escitalopram elimination
half-life, steady-state C and AUC were similar in
patients with MDD (12 to 17 years of age) compared to adult patients. No
adjustment of dosage is needed in adolescent patients.
Elderly - Escitalopram pharmacokinetics in subjects greater than or equal to 65 years of
age were compared to younger subjects in a single-dose and a multiple-dose
study. Escitalopram AUC and half-life were increased by approximately 50% in
elderly subjects, and C was unchanged. 10 mg is the
recommended dose for elderly patients [].
Lexapro (Escitalopram oxalate) Nonclinical Toxicology
13.1 Carcinogenesis, Mutagenesis, Impairment of
Fertility
Carcinogenesis
Racemic citalopram was administered in the diet to NMRI/BOM strain mice and
COBS WI strain rats for 18 and 24 months, respectively. There was no evidence
for carcinogenicity of racemic citalopram in mice receiving up to 240 mg/kg/day.
There was an increased incidence of small intestine carcinoma in rats receiving
8 or 24 mg/kg/day racemic citalopram. A no-effect dose for this finding was not
established. The relevance of these findings to humans is unknown.
Mutagenesis
Racemic citalopram was mutagenic in the
bacterial reverse mutation assay (Ames test) in 2 of 5 bacterial strains
(Salmonella TA98 and TA1537) in the absence of metabolic activation. It was
clastogenic in the Chinese hamster lung cell
assay for chromosomal aberrations in the presence and absence of metabolic
activation. Racemic citalopram was not mutagenic in the mammalian forward gene mutation assay (HPRT) in mouse lymphoma
cells or in a coupled unscheduled
DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the chromosomal aberration assay in human lymphocytes
or in two mouse micronucleus assays.
Impairment of Fertility
When racemic citalopram was administered orally to 16 male and 24 female rats
prior to and throughout mating and gestation at doses of 32, 48, and 72
mg/kg/day, mating was decreased at all doses, and fertility was decreased at
doses ≥ 32 mg/kg/day. Gestation duration was increased at 48 mg/kg/day.
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.
Lexapro (Escitalopram oxalate) Clinical Studies
14.1 Major Depressive Disorder
The efficacy of Lexapro (Escitalopram oxalate) as an acute treatment for major depressive disorder
in adolescent patients was established in an 8-week, flexible-dose,
placebo-controlled study that compared Lexapro (Escitalopram oxalate) 10-20 mg/day to placebo in
outpatients 12 to 17 years of age inclusive who met DSM-IV criteria for major
depressive disorder. The primary outcome was change from baseline to endpoint in
the Children's Depression Rating Scale - Revised (CDRS-R). In this study,
Lexapro (Escitalopram oxalate) showed statistically significant greater mean improvement compared to
placebo on the CDRS-R.
The efficacy of Lexapro (Escitalopram oxalate) in the acute treatment of major depressive disorder
in adolescents was established, in part, on the basis of extrapolation from the
8-week, flexible-dose, placebo-controlled study with racemic citalopram 20-40
mg/day. In this outpatient study in children and adolescents 7 to 17 years of
age who met DSM-IV criteria for major depressive disorder, citalopram treatment
showed statistically significant greater mean improvement from baseline,
compared to placebo, on the CDRS-R; the positive results for this trial largely
came from the adolescent subgroup.
Two additional flexible-dose, placebo-controlled MDD studies (one Lexapro (Escitalopram oxalate)
study in patients ages 7 to 17 and one citalopram study in adolescents) did not
demonstrate efficacy.
Although maintenance efficacy in adolescent patients has not been
systematically evaluated, maintenance efficacy can be extrapolated from adult
data along with comparisons of escitalopram pharmacokinetic parameters in adults
and adolescent patients.
The efficacy of Lexapro (Escitalopram oxalate) as a treatment for major depressive disorder was
established in three, 8-week, placebo-controlled studies conducted in
outpatients between 18 and 65 years of age who met DSM-IV criteria for major
depressive disorder. The primary outcome in all three studies was change from
baseline to endpoint in the Montgomery Asberg Depression Rating Scale
(MADRS).
A fixed-dose study compared 10 mg/day Lexapro (Escitalopram oxalate) and 20 mg/day Lexapro (Escitalopram oxalate) to
placebo and 40 mg/day citalopram. The 10 mg/day and 20 mg/day Lexapro (Escitalopram oxalate) treatment
groups showed statistically significant greater mean improvement compared to
placebo on the MADRS. The 10 mg and 20 mg Lexapro (Escitalopram oxalate) groups were similar on this
outcome measure.
In a second fixed-dose study of 10 mg/day Lexapro (Escitalopram oxalate) and placebo, the 10 mg/day
Lexapro (Escitalopram oxalate) treatment group showed statistically significant greater mean
improvement compared to placebo on the MADRS.
In a flexible-dose study, comparing Lexapro (Escitalopram oxalate) , titrated between 10 and 20
mg/day, to placebo and citalopram, titrated between 20 and 40 mg/day, the
Lexapro (Escitalopram oxalate) treatment group showed statistically significant greater mean
improvement compared to placebo on the MADRS.
Analyses of the relationship between treatment outcome and age, gender, and
race did not suggest any differential responsiveness on the basis of these
patient characteristics.
In a longer-term trial, 274 patients meeting (DSM-IV) criteria for major
depressive disorder, who had responded during an initial 8-week, open-label
treatment phase with Lexapro (Escitalopram oxalate) 10 or 20 mg/day, were randomized to continuation of
Lexapro (Escitalopram oxalate) at their same dose, or to placebo, for up to 36 weeks of observation for
relapse. Response during the open-label phase was defined by having a decrease
of the MADRS total score to ≤ 12. Relapse during the double-blind phase was
defined as an increase of the MADRS total score to ≥ 22, or discontinuation due
to insufficient clinical response. Patients receiving continued Lexapro (Escitalopram oxalate)
experienced a statistically significant longer time to relapse compared to those
receiving placebo.
The efficacy of Lexapro (Escitalopram oxalate) in the acute treatment of Generalized
Anxiety Disorder (GAD) was demonstrated in three, 8-week, multicenter,
flexible-dose, placebo-controlled studies that compared Lexapro (Escitalopram oxalate) 10-20 mg/day to
placebo in adult outpatients between 18 and 80 years of age who met DSM-IV
criteria for GAD. In all three studies, Lexapro (Escitalopram oxalate) showed statistically significant
greater mean improvement compared to placebo on the Hamilton Anxiety Scale
(HAM-A).
There were too few patients in differing ethnic and age groups to adequately
assess whether or not Lexapro (Escitalopram oxalate) has differential effects in these groups. There
was no difference in response to Lexapro (Escitalopram oxalate) between men and women.
Lexapro (Escitalopram oxalate) How Supplied/storage And Handling
16.1 Tablets
5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0
White to off-white, round, non-scored, film-coated. Imprint "FL" on one side
of the tablet and "5" on the other side.
10 mg Tablets:Bottle of 10 NDC # 54868-4700-0Bottle of 20 NDC # 54868-4700-4Bottle of 30 NDC # 54868-4700-1Bottle of 45 NDC # 54868-4700-5Bottle of 60 NDC # 54868-4700-2Bottle of 90 NDC # 54868-4700-6Bottle of 100 NDC # 54868-4700-3
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 "10".
20 mg Tablets:Bottle of 10 NDC # 54868-4775-0Bottle of 30 NDC # 54868-4775-1Bottle of 45 NDC # 54868-4775-3Bottle of 60 NDC # 54868-4775-4Bottle of 90 NDC # 54868-4775-5Bottle of 100 NDC # 54868-4775-2
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".
Storage and Handling
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).
Lexapro (Escitalopram oxalate) Patient Counseling Information
See FDA-approved Medication Guide
Physicians are advised to discuss the following issues with
patients for whom they prescribe Lexapro (Escitalopram oxalate) .
Prescribers or other health professionals should inform patients, their
families, and their caregivers about the benefits and risks associated with
treatment with Lexapro (Escitalopram oxalate) and should counsel them in its appropriate use. A patient
Medication Guide about “Antidepressant Medicines, Depression and other Serious
Mental Illness, and Suicidal Thoughts or Actions” is available for Lexapro (Escitalopram oxalate) . The
prescriber or health professional should instruct patients, their families, and
their caregivers to read the Medication Guide and should assist them in
understanding its contents. Patients should be given the opportunity to discuss
the contents of the Medication Guide and to obtain answers to any questions they
may have. The complete text of the Medication Guide is reprinted at the end of
this document.
Patients should be advised of the following issues and asked to alert their
prescriber if these occur while taking Lexapro (Escitalopram oxalate) .
Patients, their families, and their caregivers should be encouraged to be
alert to the emergence of anxiety, agitation, panic attacks, insomnia,
irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor
restlessness), hypomania, mania, other unusual changes in behavior, worsening of
depression, and suicidal ideation, especially early during antidepressant
treatment and when the dose is adjusted up or down. Families and caregivers of
patients should be advised to look for the emergence of such symptoms on a
day-to-day basis, since changes may be abrupt. Such symptoms should be reported
to the patient's prescriber or health professional, especially if they are
severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Symptoms such as these may be associated with an increased risk for suicidal
thinking and behavior and indicate a need for very close monitoring and possibly
changes in the medication [].
Patients should be cautioned about the risk of serotonin syndrome with the
concomitant use of and triptans, tramadol or
other serotonergic agents [].
Patients should be cautioned about the concomitant use of Lexapro (Escitalopram oxalate) and NSAIDs,
aspirin, warfarin, or other drugs that affect coagulation since combined use of
psychotropic drugs that interfere with serotonin reuptake and these agents has
been associated with an increased risk of bleeding [].
Since escitalopram is the active isomer of racemic citalopram (Celexa), the
two agents should not be coadministered. Patients should be advised to inform
their physician if they are taking, or plan to take, any prescription or
over-the-counter drugs, as there is a potential for interactions.
While patients may notice improvement with Lexapro (Escitalopram oxalate) therapy in 1 to 4 weeks,
they should be advised to continue therapy as directed.
Because psychoactive drugs may impair judgment, thinking, or motor skills,
patients should be cautioned about operating hazardous machinery, including
automobiles, until they are reasonably certain that Lexapro (Escitalopram oxalate) therapy does not
affect their ability to engage in such activities.
Patients should be told that, although Lexapro (Escitalopram oxalate) has not been shown in
experiments with normal subjects to increase the mental and motor skill
impairments caused by alcohol, the concomitant use of Lexapro (Escitalopram oxalate) and alcohol in
depressed patients is not advised.
Patients should be advised to notify their physician if they
Lexapro (Escitalopram oxalate) is indicated as an integral part of a total treatment program for MDD
that may include other measures (psychological, educational, social) for
patients with this syndrome. Drug treatment may not be indicated for all
adolescents with this syndrome. Safety and effectiveness of Lexapro (Escitalopram oxalate) in MDD has
not been established in pediatrics patients less than 12 years of age.
Antidepressants are not intended for use in the adolescent who exhibits symptoms
secondary to environmental factors and/or other primary psychiatric disorders.
Appropriate educational placement is essential and psychosocial intervention is
often helpful. When remedial measures alone are insufficient, the decision to
prescribe antidepressant medication will depend upon the physician's assessment
of the chronicity and severity of the patient's symptoms.
Read the Medication Guide that comes with you or your family member's
antidepressant medicine. This Medication Guide is only about the risk of
suicidal thoughts and actions with antidepressant medicines.
This Medication Guide has been approved by the U.S. Food and Drug
Administration for all antidepressants.
Forest Pharmaceuticals, Inc.Subsidiary of Forest Laboratories,
Inc.St. Louis, MO 63045 USALicensed from H. Lundbeck A/S
© 2009 Forest Laboratories, Inc.Rev. 01/09
Lexapro (Escitalopram oxalate) Principal Display Panel
Lexapro (Escitalopram oxalate) , 5 mg
Lexapro (Escitalopram oxalate) , 10 mg
Lexapro (Escitalopram oxalate) , 20 mg
