Lexapro (Escitalopram Oxalate): Side Effects, Interactions, Warning, Dosage & Uses

Clinical Worsening And Suicide Risk

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 longstanding
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 Table 1.

TABLE 1

Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
Increases Compared to Placebo
<18 14 additional cases
18-24 5 additional cases
Decreases Compared to Placebo
25-64 1 fewer case
≥65 6 fewer cases

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 [see DOSAGE
AND ADMINISTRATION
].

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 [see also Patient
Counseling Information
]. Prescriptions for Lexapro should be written for
the smallest quantity of tablets consistent with good patient management, in
order to reduce the risk of overdose.

Screening Patients For Bipolar Disorder

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 is not approved for use in treating bipolar depression.

Serotonin Syndrome

The development of a potentially life-threatening
serotonin syndrome has been reported with SNRIs and SSRIs, including Lexapro, alone
but particularly with concomitant use of other serotonergic drugs (including
triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,
buspirone, amphetamines, and St. John’s Wort) and with drugs that impair
metabolism of serotonin (in particular, MAOIs, both those intended to treat
psychiatric disorders and also others, such as linezolid and intravenous
methylene blue).

Serotonin syndrome symptoms may include mental status
changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability
(e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing,
hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus,
hyperreflexia, incoordination) seizures, and/or gastrointestinal symptoms
(e.g., nausea, vomiting, diarrhea). Patients should be monitored for the
emergence of serotonin syndrome.

The concomitant use of Lexapro with MAOIs intended to
treat psychiatric disorders is contraindicated. Lexapro should also not be started
in a patient who is being treated with MAOIs such as linezolid or intravenous
methylene blue. All reports with methylene blue that provided information on
the route of administration involved intravenous administration in the dose
range of 1 mg/kg to 8 mg/kg. No reports involved the administration of
methylene blue by other routes (such as oral tablets or local tissue injection)
or at lower doses. There may be circumstances when it is necessary to initiate
treatment with an MAOI such as linezolid or intravenous methylene blue in a
patient taking Lexapro. Lexapro should be discontinued before initiating
treatment with the MAOI [see CONTRAINDICATIONS and DOSAGE AND
ADMINISTRATION
].

If concomitant use of Lexapro with other serotonergic
drugs including, triptans, tricyclic antidepressants, fentanyl, lithium,
tramadol, buspirone, tryptophan, amphetamine and St. John’s Wort is clinically
warranted, patients should be made aware of a potential increased risk for
serotonin syndrome, particularly during treatment initiation and dose
increases.

Treatment with Lexapro and any concomitant serotonergic
agents, should be discontinued immediately if the above events occur and supportive
symptomatic treatment should be initiated.

Discontinuation Of Treatment With Lexapro

During marketing of Lexapro 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. 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 [see DOSAGE
AND ADMINISTRATION
].

Although anticonvulsant effects of racemic citalopram
have been observed in animal studies, Lexapro 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, cases of convulsion have been reported in association with Lexapro
treatment. Like other drugs effective in the treatment of major depressive
disorder, Lexapro should be introduced with care in patients with a history of
seizure disorder.

Activation Of Mania/Hypomania

In placebo-controlled trials of Lexapro in major
depressive disorder, activation of mania/hypomania was reported in one (0.1%)
of 715 patients treated with Lexapro and in none of the 592 patients treated
with placebo. One additional case of hypomania has been reported in association
with Lexapro 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 should be used cautiously in patients with a
history of mania.

Hyponatremia may occur as a result of treatment with
SSRIs and SNRIs, including Lexapro. In many cases, this hyponatremia appears to
be the result of the syndrome of inappropriate antidiuretic hormone secretion
(SIADH), and was reversible when Lexapro was discontinued. Cases with serum
sodium lower than 110 mmol/L have been reported. Elderly patients may be at
greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients
taking diuretics or who are otherwise volume depleted may be at greater risk [see
Geriatric Use]. Discontinuation of Lexapro should be considered in
patients with symptomatic hyponatremia and appropriate medical intervention
should be instituted.

Signs and symptoms of hyponatremia include headache,
difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness,
which may lead to falls. Signs and symptoms associated with more severe and/or
acute cases have included hallucination, syncope, seizure, coma, respiratory arrest,
and death.

Abnormal Bleeding

SSRIs and SNRIs, including Lexapro, may increase the risk
of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs,
warfarin, and other anticoagulants may add to the risk. Case reports and epidemiological
studies (case-control and cohort design) have demonstrated an association
between use of drugs that interfere with serotonin reuptake and the occurrence of
gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have
ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening
hemorrhages.

Patients should be cautioned about the risk of bleeding
associated with the concomitant use of Lexapro and NSAIDs, aspirin, or other drugs
that affect coagulation.

Interference With Cognitive And Motor Performance

In a study in normal volunteers, Lexapro 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 therapy
does not affect their ability to engage in such activities.

Angle Closure Glaucoma

Angle Closure Glaucoma: The pupillary dilation that
occurs following use of many antidepressant drugs including Lexapro may trigger
an angle closure attack in a patient with anatomically narrow angles who does
not have a patent iridectomy.

Use In Patients With Concomitant Illness

Clinical experience with Lexapro in patients with certain
concomitant systemic illnesses is limited. Caution is advisable in using Lexapro
in patients with diseases or conditions that produce altered metabolism or
hemodynamic responses.

Lexapro 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 in hepatically impaired patients is 10 mg/day [see DOSAGE
AND ADMINISTRATION
].

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, however, it should be used with caution
in such patients [see DOSAGE AND ADMINISTRATION].

Patient Counseling Information

Information For Patients

Physicians are advised to discuss the following issues
with patients for whom they prescribe Lexapro.

General Information About Medication Guide

Prescribers or other health professionals should inform
patients, their families, and their caregivers about the benefits and risks associated
with treatment with Lexapro and should counsel them in its appropriate use. A
patient about “Antidepressant Medicines, Depression and other
Serious Mental Illness, and Suicidal Thoughts or Actions” is available for
Lexapro. 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.

Clinical Worsening And Suicide Risk

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 [see WARNINGS AND PRECAUTIONS].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin
syndrome with the concomitant use of Lexapro with other serotonergic drugs including
triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,
buspirone, amphetamines and St. John’s Wort, and with drugs that impair
metabolism of serotonin (in particular, MAOIs, both those intended to treat
psychiatric disorders and also others, such as linezolid) [see WARNINGS AND
PRECAUTIONS
].

Abnormal Bleeding

Patients should be cautioned about the concomitant use of
Lexapro 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 [see
WARNINGS AND PRECAUTIONS
].

Angle Closure Glaucoma

Patients should be advised that taking Lexapro can cause
mild pupillary dilation, which in susceptible individuals, can lead to an episode
of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle
glaucoma because angle closure glaucoma, when diagnosed, can be treated
definitively with iridectomy. Open-angle glaucoma is not a risk factor for
angle closure glaucoma. Patients may wish to be examined to determine whether
they are susceptible to angle closure, and have a prophylactic procedure (e.g.,
iridectomy), if they are susceptible [see WARNINGS AND PRECAUTIONS].

Concomitant Medications

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.

Continuing The Therapy Prescribed

While patients may notice improvement with Lexapro
therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.

Interference With Psychomotor Performance

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 therapy
does not affect their ability to engage in such activities.

Patients should be told that, although Lexapro 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 and alcohol
in depressed patients is not advised.

Pregnancy And Breast Feeding

Patients should be advised to notify their physician if
they

Need For Comprehensive Treatment Program

Lexapro 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 in
MDD has not been established in pediatric 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.

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.

Racemic citalopram was mutagenic in the in vitro 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 in
vitro Chinese hamster lung cell assay for chromosomal aberrations in the
presence and absence of metabolic activation. Racemic citalopram was not
mutagenic in the in vitro mammalian forward gene mutation assay (HPRT) in mouse
lymphoma cells or in a coupled in vitro/in vivo unscheduled DNA synthesis (UDS)
assay in rat liver. It was not clastogenic in the in vitro chromosomal
aberration assay in human lymphocytes or in two in vivo 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.

Use In Specific Populations

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
≥ 56 times the maximum recommended human dose [MRHD] of 20 mg/day on a
body surface area [mg/m²] 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/m² basis. No teratogenicity was
observed at any of the doses tested (as high as 75 times the MRHD on a mg/m²
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/m² 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/m² 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 ≥ 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 and other SSRIs or serotonin and
norepinephrine reuptake inhibitors (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 [see WARNINGS AND PRECAUTIONS].

Infants exposed to SSRIs in pregnancy may have an
increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN
occurs in 1 – 2 per 1,000 live births in the general population and is
associated with substantial neonatal morbidity and mortality. Several recent
epidemiologic studies suggest a positive statistical association between SSRI
use (including Lexapro) in pregnancy and PPHN. Other studies do not show a
significant statistical association.

Physicians should also note the results of a prospective
longitudinal study of 201 pregnant women with a history of major depression, who
were either on antidepressants or had received antidepressants less than 12
weeks prior to their last menstrual period, and were in remission. Women who
discontinued antidepressant medication during pregnancy showed a significant
increase in relapse of their major depression compared to those women who
remained on antidepressant medication throughout pregnancy.

When treating a pregnant woman with Lexapro, the
physician should carefully consider both the potential risks of taking an SSRl,
along with the established benefits of treating depression with an
antidepressant. This decision can only be made on a case by case basis [see DOSAGE
AND ADMINISTRATION
].

Labor And Delivery

The effect of Lexapro on labor and delivery in humans is
unknown.

Nursing Mothers

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 is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Lexapro have been
established in adolescents (12 to 17 years of age) for the treatment of major depressive
disorder [see Clinical Studies]. 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.

The safety and effectiveness of Lexapro have not been
established in pediatric (younger than 12 years of age) patients with major depressive
disorder. In a 24-week, open- label safety study in 118 children (aged 7 to 11
years) who had major depressive disorder, the safety findings were consistent
with the known safety and tolerability profile for Lexapro.

Safety and effectiveness of Lexapro has not been
established in pediatric patients less than 18 years of age with Generalized
Anxiety Disorder.

Decreased appetite and weight loss have been observed in
association with the use of SSRIs. Consequently, regular monitoring of weight
and growth should be performed in children and adolescents treated with an SSRI
such as Lexapro.

Geriatric Use

Approximately 6% of the 1144 patients receiving
escitalopram in controlled trials of Lexapro in major depressive disorder and
GAD were 60 years of age or older; elderly patients in these trials received
daily doses of Lexapro 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 cannot be ruled
out.

SSRIs and SNRIs, including Lexapro, have been associated
with cases of clinically significant hyponatremia in elderly patients, who may
be at greater risk for this adverse event [see Hyponatremia].

In two pharmacokinetic studies, escitalopram half-life
was increased by approximately 50% in elderly subjects as compared to young subjects
and Cmax was unchanged [see CLINICAL PHARMACOLOGY]. 10 mg/day is the
recommended dose for elderly patients [see DOSAGE AND ADMINISTRATION].

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.

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