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Lexapro
Overview
What is Lexapro?
Lexapro® (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 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 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.
What does Lexapro look like?
What are the available doses of Lexapro?
Lexapro 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 oral solution contains escitalopram oxalate equivalent to
1 mg/mL escitalopram base.
What should I talk to my health care provider before I take Lexapro?
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 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 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 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 is
administered to a nursing woman.
Safety and effectiveness of Lexapro has not been established in
pediatric patients (less than 12 years of age) with Major Depressive Disorder.
Safety and effectiveness of Lexapro 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 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 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 ].
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.
How should I use Lexapro?
see Clinical Studies ()
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 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 should be administered once daily, in the morning or
evening, with or without food.
Initial Treatment
Adolescents
see Clinical
Studies ()
Adults
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 []. If the
dose is increased to 20 mg, this should occur after a minimum of one week.
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 in adults 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 Studies ()].
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. Patients should be periodically reassessed to determine the
need for maintenance treatment.
Initial Treatment
Adults
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.
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 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 should be used with caution in patients with severe renal
impairment.
Symptoms associated with discontinuation of Lexapro 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 therapy. Similarly, at least 14 days should be allowed
after stopping Lexapro before starting an MAOI [].
What interacts with Lexapro?
Sorry No Records found
What are the warnings of Lexapro?
Sorry No Records found
What are the precautions of Lexapro?
Sorry No Records found
What are the side effects of Lexapro?
Sorry No records found
What should I look out for while using Lexapro?
Concomitant use in patients taking monoamine oxidase inhibitors
(MAOIs) is contraindicated [].
Concomitant use in patients taking pimozide is contraindicated
[].
Lexapro is contraindicated in patients with a hypersensitivity to
escitalopram or citalopram or any of the inactive ingredients in Lexapro.
Antidepressants increased the risk compared to
placebo of suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults in short-term studies of major depressive disorder
(MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or
any other antidepressant in a child, adolescent, or young adult must balance
this risk with the clinical need. 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 in risk with antidepressants compared to
placebo in adults aged 65 and older. Depression and certain other psychiatric
disorders are themselves associated with increases in the risk of suicide.
Patients of all ages who are started on antidepressant therapy should be
monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should be
advised of the need for close observation and communication with the prescriber.
Lexapro is not approved for use in pediatric patients less than 12 years of
age.
[See Warnings and Precautions: Clinical
Worsening and Suicide Risk (), Patient Counseling
Information: Information for Patients (), and Used in
Specific Populations: Pediatric Use ()].
What might happen if I take too much Lexapro?
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
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.
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.
How should I store and handle Lexapro?
Store bottles of 1000 SINGULAIR 5-mg chewable tablets and 8000 SINGULAIR 10-mg film-coated tablets at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture and light. Store in original container. When product container is subdivided, repackage into a well-closed, light resistant container. 16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).16.1 Tablets5 mg Tablets:Bottle of 10 NDC # 54868-5951-1Bottle of 30 NDC # 54868-5951-2Bottle of 90 NDC # 54868-5951-0White 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 # 54868-4700-3White 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 # 54868-4775-2White 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 HandlingStore at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).
Clinical Information
Chemical Structure
No Image foundClinical 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).
In vitro
in
vivo
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.
In vitro
Population Subgroups
Age
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 [].
Gender
Reduced hepatic function
see Dosage and Administration ()
Reduced renal function
Drug-Drug Interactions
In vitro
in vitro
in vivo
in vivo
Drug Interactions ()
Non-Clinical Toxicology
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated [].Concomitant use in patients taking pimozide is contraindicated [].
Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro.
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients less than 12 years of age.
[See Warnings and Precautions: Clinical Worsening and Suicide Risk (), Patient Counseling Information: Information for Patients (), and Used in Specific Populations: Pediatric Use ()].
Increased nephrotoxicity has been reported following concomitant administration of cephalosporins and aminoglycoside antibiotics.
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 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.
The concomitant use of Lexapro with MAOIs intended to treat depression is contraindicated. If concomitant treatment of Lexapro 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 with serotonin precursors (such as tryptophan) is not recommended. Treatment with Lexapro 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 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 [].
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.
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.
see Geriatric Use (
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.
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.
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 [].
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 [].
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 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 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.
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.
Clinical Trial Data Sources
Pediatrics (6 -17 years)
Adverse events were collected in 576 pediatric patients (286 Lexapro, 290 placebo) with major depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of Lexapro in pediatric patients less than 12 years of age has not been established.
Adults
Adverse events information for Lexapro 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 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 Associated with Discontinuation of Treatment
Major Depressive Disorder
Pediatrics (6 -17 years)
Adverse events were associated with discontinuation of 3.5% of 286 patients receiving Lexapro and 1% of 290 patients receiving placebo. The most common adverse event (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).
Adults
Among the 715 depressed patients who received Lexapro 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 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 was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients).
Generalized Anxiety Disorder
Adults
Among the 429 GAD patients who received Lexapro 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, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and fatigue (1%).
Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials
Major Depressive Disorder
Pediatrics (6 -17 years)
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 and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion.
Adults
The most commonly observed adverse reactions in Lexapro 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.
Table 2
TABLE 2 Treatment-Emergent Adverse Reactions observed with a frequency of ≥ 2% and greater than placebo for Major Depressive Disorder
Generalized Anxiety Disorder
Adults
The most commonly observed adverse reactions in Lexapro 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.
Table 3
TABLE 3 Treatment-Emergent Adverse Reactions observed with a frequency of greater than or equal to 2% and greater than placebo for
Generalized Anxiety Disorder
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).