PRINCIPAL DISPLAY PANEL

NDC 0456-2101-08
Lexapro
escitalopram
Oral Solution 5 mg/5mL
8 fl oz (240 mL)
Rx Only

1****INDICATIONS AND USAGE

Lexapro is indicated for the treatment of:

• major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older.

• generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older.

6**ADVERSE REACTIONS**

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.1)]

• Serotonin syndrome [see Warnings and Precautions (5.2)]

• Discontinuation syndrome [see Warnings and Precautions (5.3)]

• Seizures [see Warnings and Precautions (5.4)]

• Activation of mania or hypomania [see Warnings and Precautions (5.5)]

• Hyponatremia [see Warnings and Precautions (5.6)]

• Increased Risk of Bleeding [see Warnings and Precautions (5.7)]

• Interference with Cognitive and Motor Performance [see Warnings and Precautions (5.8)]

• Angle-closure glaucoma [see Warnings and Precautions (5.9)]

• Use in Patients with Concomitant Illness [see Warnings and Precautions (5.10)]

• Sexual Dysfunction [see Warnings and Precautions (5.11)]

6.1ClinicalTrials****Experience

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

Adults
Adverse reactions 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 reaction 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 reactions 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 reactions without first grouping similar types of reactions 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 reactions.

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.

Pediatric Patients

Adverse reaction information for pediatric patients was collected in double- blind placebo-controlled studies in 576 pediatric patients 6 to 17 years of age, (286 Lexapro, 290 placebo) with major depressive disorder and in 273 pediatric patients 7 to 17 years of age (137 Lexapro, 136 placebo) with generalized anxiety disorder.

The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD or less than 7 years of age with GAD.

Adverse****Reactions****Associated with Discontinuation of Treatment

Major Depressive Disorder

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 reactions in patients receiving 10 mg/day Lexapro was not significantly different from the rate of discontinuation for adverse reactions in patients receiving placebo. The rate of discontinuation for adverse reactions 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 reactions in patients receiving 10 mg/day Lexapro (4%) and placebo (3%). Adverse reactions 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).

Pediatric Patients

Adverse reactions in pediatric patients 6 to 17 years of age were associated with discontinuation of 3.5% of 286 patients receiving Lexapro and 1% of 290 patients receiving placebo. The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).

The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.

Generalized Anxiety Disorder

Adults
Among the 429 GAD patients who received Lexapro 10 to 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 reactions 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%).

Pediatric Patients

Adverse reactions in pediatric patients 7 to 17 years were associated with discontinuation of 2.9% of 137 patients receiving Lexapro and 1.5% of 136 patients receiving placebo. The most common adverse reaction (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was activation syndrome (1% Lexapro, 0% placebo), intentional self injury (1% Lexapro, 0% placebo), epistaxis (1% Lexapro, 0% placebo), and nausea (1% Lexapro, 0% placebo).

Incidence of AdverseReactions in Placebo-Controlled Clinical Trials

M****ajor Depressive 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 insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue, and somnolence.

Table 2 enumerates the incidence, rounded to the nearest percent, of adverse reactions that occurred among 715 depressed patients who received Lexapro at doses ranging from 10 to 20 mg/day in placebo-controlled trials. Reactions included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.

TABLE 2
Adverse Reactions observed with a frequency of≥2% and greater than placebo for Major Depressive Disorder (Adults)
Adverse Reaction	Lexapro	Placebo
	(N=715) %	(N=592) %
Autonomic Nervous****System Disorders
Dry Mouth	6%	5%
Sweating Increased	5%	2%
Central & Peripheral Nervous System Disorders
Dizziness	5%	3%
Gastrointestinal Disorders
Nausea	15%	7%
Diarrhea	8%	5%
Constipation	3%	1%
Indigestion	3%	1%
Abdominal Pain	2%	1%
General
Influenza-like Symptoms	5%	4%
Fatigue	5%	2%
Psychiatric Disorders
Insomnia	9%	4%
Somnolence	6%	2%
Appetite Decreased	3%	1%
Libido Decreased	3%	1%
Respiratory System Disorders
Rhinitis	5%	4%
Sinusitis	3%	2%
Urogenital
Ejaculation Disorder1,2	9%	<1%
Impotence2	3%	<1%
Anorgasmia3	2%	<1%

1Primarily ejaculatory delay.
2Denominator used was for males only (N=225 Lexapro; N=188 placebo).
3Denominator used was for females only (N=490 Lexapro; N=404 placebo).

Pediatric Patients

The overall profile of adverse reactions in pediatric patients 6 to 17 years in major depressive disorder was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 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.

The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.

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 enumerates the incidence, rounded to the nearest percent of treatment-emergent adverse reactions that occurred among 429 GAD patients who received Lexapro 10 to 20 mg/day in placebo-controlled trials. Reactions included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.

TABLE 3
Adverse Reactions Observed with a Frequency of ≥ 2% and > placebo for Generalized Anxiety Disorder (Adults)
Adverse Reactions****	Lexapro	Placebo
	(N=429) %	**(**N=427) %
Autonomic Nervous System Disorders
Dry Mouth	9%	5%
Sweating Increased	4%	1%
Central & Peripheral Nervous System Disorders
Headache	24%	17%
Paresthesia	2%	1%
Gastrointestinal Disorders
Nausea	18%	8%
Diarrhea	8%	6%
Constipation	5%	4%
Indigestion	3%	2%
Vomiting	3%	1%
Abdominal Pain	2%	1%
Flatulence	2%	1%
Toothache	2%	0%
General
Fatigue	8%	2%
Influenza-like Symptoms	5%	4%
Musculoskeletal System Disorder
Neck/Shoulder Pain	3%	1%
Psychiatric Disorders
Somnolence	13%	7%
Insomnia	12%	6%
Libido Decreased	7%	2%
Dreaming Abnormal	3%	2%
Appetite Decreased	3%	1%
Lethargy	3%	1%
Respiratory System Disorders
Yawning	2%	1%
Urogenital
Ejaculation Disorder1,2	14%	2%
Anorgasmia3	6%	<1%
Menstrual Disorder	2%	1%

1Primarily ejaculatory delay.
2Denominator used was for males only (N=182 Lexapro; N=195 placebo).
3Denominator used was for females only (N=247 Lexapro; N=232 placebo).

Pediatric Patients

The overall profile of adverse reactions in pediatric patients 7 to 17 years in generalized anxiety disorder was generally similar to that seen in adult studies, as shown in Table 3. However, the following adverse reactions (excluding those which appear in Table 3) were reported at an incidence of at least 2% for Lexapro and greater than placebo: dizziness (3% Lexapro and 2% placebo), nasopharyngitis (3% Lexapro and 1% placebo), abdominal discomfort (3% Lexapro and 1% placebo), anxiety (3% Lexapro and 1% placebo), irritability (2% Lexapro and 1% placebo), and anger (2% Lexapro and 0% placebo).

Dose Dependency of Adverse****Reactions
The potential dose dependency of common adverse reactions (defined as an incidence rate of ≥5% in either the 10 mg or 20 mg Lexapro groups) was examined on the basis of the combined incidence of adverse reactions in two fixed-dose trials. The overall incidence rates of adverse reactions in 10 mg Lexapro-treated patients (66%) was similar to that of the placebo-treated patients (61%), while the incidence rate in 20 mg/day Lexapro-treated patients was greater (86%). Table 4 shows common adverse reactions that occurred in the 20 mg/day Lexapro group with an incidence that was approximately twice that of the 10 mg/day Lexapro group and approximately twice that of the placebo group.

TABLE 4
Incidence of Common Adverse****Reactions****in Patients with Major Depressive Disorder
Adverse Reaction	Placebo	10 mg/day	20 mg/day
	(N=311)	Lexapro	Lexapro
		(N=310)	(N=125)
Insomnia	4%	7%	14%
Diarrhea	5%	6%	14%
Dry Mouth	3%	4%	9%
Somnolence	1%	4%	9%
Dizziness	2%	4%	7%
Sweating Increased	<1%	3%	8%
Constipation	1%	3%	6%
Fatigue	2%	2%	6%
Indigestion	1%	2%	6%

Male and Female Sexual Dysfunction with SSRIs
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.

Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.

TABLE 5
Incidence of Sexual Side Effects in Placebo-Controlled Clinical Trials
Adverse Event	Lexapro	Placebo
	In Males Only
	(N=407)	(N=383)
Ejaculation Disorder (primarily ejaculatory delay)	12%	1%
Libido Decreased	6%	2%
Impotence	2%	<1%
	In Females Only
	(N=737)	(N=636)
Libido Decreased	3%	1%
Anorgasmia	3%	<1%

There are no adequately designed studies examining sexual dysfunction with escitalopram treatment.

Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Vital Sign Changes
Lexapro and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Lexapro treatment. In addition, a comparison of supine and standing vital sign measures in subjects receiving Lexapro indicated that Lexapro treatment is not associated with orthostatic changes.

Weight Changes
Patients treated with Lexapro in controlled trials did not differ from placebo-treated patients with regard to clinically important change in body weight.

Laboratory Changes
Lexapro and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Lexapro treatment.

ECG Changes
Electrocardiograms from Lexapro (N=625) and placebo (N=527) groups were compared with respect to outliers defined as subjects with QTc changes over 60 msec from baseline or absolute values over 500 msec post-dose, and subjects with heart rate increases to over 100 bpm or decreases to less than 50 bpm with a 25% change from baseline (tachycardic or bradycardic outliers, respectively). None of the patients in the Lexapro group had a QTcF interval

500 msec or a prolongation >60 msec compared to 0.2% of patients in the placebo group. The incidence of tachycardic outliers was 0.2% in the Lexapro and the placebo group. The incidence of bradycardic outliers was 0.5% in the Lexapro group and 0.2% in the placebo group.

QTcF interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg) controlled cross-over, escalating multiple dose study in 113 healthy subjects. The maximum mean (95% upper confidence bound) difference from placebo arm were 4.5 (6.4) and 10.7 (12.7) msec for 10 mg and supratherapeutic 30 mg escitalopram given once daily, respectively. Based on the established exposure-response relationship, the predicted QTcF change from placebo arm (95% confidence interval) under the Cmax for the dose of 20 mg is 6.6 (7.9) msec. Escitalopram 30 mg given once daily resulted in mean Cmax of 1.7-fold higher than the mean Cmax for the maximum recommended therapeutic dose at steady state (20 mg). The exposure under supratherapeutic 30 mg dose is similar to the steady state concentrations expected in CYP2C19 poor metabolizers following a therapeutic dose of 20 mg.

OtherReactionsObserved During the Premarketing Evaluation of Lexapro
Following is a list of treatment-emergent adverse reactions, as defined in the introduction to theADVERSE REACTIONS section, reported by the 1428 patients treated with Lexapro for periods of up to one year in double-blind or open-label clinical trials during its premarketing evaluation. The listing does not include those reactions already listed in**Tables 2**** &**3, those reactions for which a drug cause was remote and at a rate less than 1% or lower than placebo, those reactions which were so general as to be uninformative, and those reactions reported only once which did not have a substantial probability of being acutely life threatening. Reactions are categorized by body system. Reactions of major clinical importance are described in the Warnings and Precautions section (5).

Cardiovascular: hypertension, palpitation.

Central and Peripheral Nervous System Disorders: light-headed feeling, migraine.

Gastrointestinal Disorders: abdominal cramp, heartburn, gastroenteritis.

General: allergy, chest pain, fever, hot flushes, pain in limb.

Metabolic and Nutritional Disorders: increased weight.

Musculoskeletal System Disorders: arthralgia, myalgia jaw stiffness.

Psychiatric Disorders: appetite increased, concentration impaired, irritability.

Reproductive Disorders/Female: menstrual cramps, menstrual disorder.

Respiratory System Disorders: bronchitis, coughing, nasal congestion, sinus congestion, sinus headache.

Skin and Appendages Disorders: rash.

Special Senses: vision blurred, tinnitus.

Urinary System Disorders: urinary frequency, urinary tract infection.

6.2****Post-Marketing Experience

Adverse Reactions****Reported Subsequent to the Marketing of Escitalopram
The following adverse reactions have been identified during post-approval use of Lexapro. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: anemia, agranulocytis, aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, leukopenia, thrombocytopenia.

Cardiac Disorders: atrial fibrillation, bradycardia, cardiac failure, myocardial infarction, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia.

Ear and labyrinth disorders: vertigo

Endocrine Disorders: diabetes mellitus, hyperprolactinemia, SIADH.

Eye Disorders: angle closure glaucoma, diplopia, mydriasis, visual disturbance.

Gastrointestinal Disorder: dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage.
General Disorders and Administration Site Conditions: abnormal gait, asthenia, edema, fall, feeling abnormal, malaise.

Hepatobiliary Disorders: fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis.

Immune System Disorders: allergic reaction, anaphylaxis.

Investigations: bilirubin increased, decreased weight, electrocardiogram QT prolongation, hepatic enzymes increased, hypercholesterolemia, INR increased, prothrombin decreased.

Metabolism and Nutrition Disorders: hyperglycemia, hypoglycemia, hypokalemia, hyponatremia.

Musculoskeletal and Connective Tissue Disorders: muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis.

Nervous System Disorders: akathisia, amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions), hypoaesthesia, myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor.

Pregnancy, Puerperium and Perinatal Conditions: spontaneous abortion.

Psychiatric Disorders: acute psychosis, aggression, agitation, anger, anxiety, apathy, completed suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt, suicidal ideation, suicidal tendency.

Renal and Urinary Disorders: acute renal failure, dysuria, urinary retention.

Reproductive System and Breast Disorders: menorrhagia, priapism.

Respiratory, Thoracic and Mediastinal Disorders: anosmia, dyspnea, epistaxis, pulmonary embolism, hyposmia, pulmonary hypertension of the newborn.

Skin and Subcutaneous Tissue Disorders: alopecia, angioedema, dermatitis, drug reaction with eosinophilia and systemic symptoms (DRESS), ecchymosis, erythema multiforme, photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis, urticaria.

Vascular Disorders: deep vein thrombosis, flushing, hypertensive crisis, hypotension, orthostatic hypotension, phlebitis, thrombosis.

7****DRUG INTERACTIONS

Table 6 presents clinically important drug interactions with Lexapro.

TABLE 6 Clinically Important Drug Interactions with Lexapro

Monoamine Oxidase Inhibitors (MAOIs)
Clinical Impact:	Concomitant use of SSRIs, including Lexapro, and MAOIs increases the risk of serotonin syndrome.
Intervention:	Lexapro is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.7), Contraindications (4), and Warnings and Precautions (5.2)].
Pimozide
Clinical Impact:	Concomitant use of racemic citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of racemic citalopram alone [see Clinical Pharmacology (12.3)].
Intervention:	Lexapro is contraindicated in patients taking pimozide [see Contraindications (4)].
Other****Serotonergic Drugs
Clinical Impact:	Concomitant use of Lexapro and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome.
Intervention:	Monitor patients for signs and symptoms of serotonin syndrome, particularly during Lexapro initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of Lexapro and/or concomitant serotonergic drugs [see Warning and Precautions (5.2)].
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
Clinical Impact:	Concomitant use of Lexapro and an antiplatelet or anticoagulant may potentiate the risk of bleeding.
Intervention:	Inform patients of the increased risk of bleeding associated with the concomitant use of Lexapro and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio [see Warning and Precautions (5.7)].
Sumatriptan
Clinical Impact:	There have been postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of an SSRI and sumatriptan.
Intervention:	If concomitant treatment with sumatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised [see Warning and Precautions (5.2)].
Carbamazepine
Clinical Impact:	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.
Intervention:	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.
Drugs Metabolized by CYP2D6
Clinical Impact:	Coadministration of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single dose of 50 mg), a substrate for CYP2D6, resulted in a 40% increase in Cmax and a 100% increase in AUC of desipramine.
Intervention:	The clinical significance of this finding is unknown. Exercise caution during coadministration of escitalopram and drugs metabolized by CYP2D6.

RECENT MAJOR CHANGES

Indications (1)	5/2023
Dosage and Administration (2.2, 2.3, 2.5) Dosage and Administration, Use of Lexapro with Other MAOIs such as Linezolid or Methylene Blue (2.7) - Removed	5/2023 5/2023
Warnings and Precautions (5.2, 5.7)	8/2023

2****DOSAGE AND ADMINISTRATION

2.1****Major Depressive Disorder

Adults

The recommended dosage of Lexapro in adults is 10 mg once daily. A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.

Pediatric Patients 12 years of age and older

The recommended dosage of Lexapro in pediatric patients 12 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 3 weeks.****

2.2****Generalized Anxiety Disorder

Adults

The recommended starting dosage of Lexapro in adults is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 1 week.

Pediatric Patients 7 years of age and older

The recommended starting dosage of Lexapro for pediatric patients ages 7 years of age and older is 10 mg once daily. Depending on clinical response and tolerability, dosage may be increased to the maximum recommended dosage of 20 mg once daily at an interval of no less than 2 weeks.

2.3****Administration Information

Administer Lexapro orally once daily, in the morning or evening, with or without food.

2.4Screen for Bipolar Disorder Prior to Starting Lexapro

Prior to initiating treatment with Lexapro or another antidepressant, screen patients for a personal family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.5)].

2.5Recommended Dosage for Specific Populations

The recommended dosage for most elderly patients and patients with hepatic impairment is 10 mg once daily [see Use in Specific Populations (8.5, 8.6)].

The recommended dosage for Lexapro in adults with a creatinine clearance less than 20 mL/minute has not been determined. No dosage adjustment is necessary for patients with mild or moderate renal impairment [see Use in Specific Populations (8.7)].

2.6Discontinuation of Treatment with Lexapro

Symptoms associated with discontinuation of Lexapro and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. 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.

**2.7Switching Patients to or from a Monoamine Oxidase Inhibitor

(MAOI) Antidepressant**

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Lexapro. Conversely, at least 14 days should be allowed after stopping Lexapro before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4)].

3****DOSAGE FORMS AND STRENGTHS

Tablets

5 mg: 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: 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: 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".

Oral Solution

1 mg/mL: Clear, colorless to opalescent liquid, peppermint flavor (not currently being marketed).

8**USE IN SPECIFIC POPULATIONS**

8.1****Pregnancy

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.

Risk Summary

Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.7) and Clinical Considerations].

Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage. There are risks of persistent pulmonary hypertension of the newborn (PPHN) (see Data) and poor neonatal adaptation (see Clinical Considerations) with exposure to selective serotonin reuptake inhibitors (SSRIs), including LEXAPRO, during pregnancy. There are risks associated with untreated depression in pregnancy (see Clinical Considerations).

In animal reproduction studies, both escitalopram and racemic citalopram have been shown to have adverse effects on embryo/fetal and postnatal development, including fetal structural abnormalities, when administered at doses greater than human therapeutic doses (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-associated maternal risk and/or embryo/fetal risk

Women who discontinue antidepressants are more likely to experience a relapse of major depression than women who continue antidepressants. This finding is from a prospective longitudinal study of 201 pregnant women with a history of major depression, who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

Maternal Adverse Reactions

Use of Lexapro in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.7)].

Fetal/Neonatal adverse reactions

Neonates exposed to SSRIs or SNRIs, including Lexapro, late in 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 (5.2)].

Data

Human Data

Exposure to SSRIs, particularly later in pregnancy, may increase the risk for PPHN. PPHN occurs in 1-2 per 1000 live births in the general populations and is associated with substantial neonatal morbidity and mortality.

Animal Data

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 ≥ 55 times the maximum recommended human dose (MRHD) of 20 mg/day on a 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 27 times the MRHD of 20 mg on a mg/m2 basis. No malformations were observed at any of the doses tested (as high as 73 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 23 times the MRHD of 20 mg 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 of 20 mg on a mg/m2 basis.

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, which is approximately 18 times the MRHD of 60 mg/day on a mg/m2 basis. This dose was also associated with maternal toxicity (clinical signs, decreased body weight gain). The developmental no- effect dose was 56 mg/kg/day is approximately 9 times the MRHD on a mg/m2 basis. 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, or approximately 5 times the MRHD on a mg/m2 basis. Thus, developmental 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, which is approximately 5 times the MRHD of 60 mg on a mg/m2 basis. The no-effect dose was 12.8 mg/kg/day is approximately 2 times the MRHD on a mg/m2 basis. Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses ≥ 24 mg/kg/day, approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study.

8.2****Lactation

Risk Summary

Data from the published literature report the presence of escitalopram and desmethylescitalopram in human milk (see Data). There are reports of excessive sedation, restlessness, agitation, poor feeding and poor weight gain in infants exposed to escitalopram, through breast milk (see Clinical Considerations). There are no data on the effects of escitalopram or its metabolites on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LEXAPRO and any potential adverse effects on the breastfed child from LEXAPRO or from the underlying maternal condition.

Clinical Considerations

Infants exposed to LEXAPRO should be monitored for excess sedation, restlessness, agitation, poor feeding and poor weight gain.

Data

A study of 8 nursing mothers on escitalopram with daily doses of 10-20 mg/day 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.

8.4****Pediatric Use

Major Depressive Disorder

The safety and effectiveness of Lexapro for the treatment of major depressive disorder have been established in pediatric patients 12 years of age and older. Use of Lexapro for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared Lexapro 10 mg to 20 mg once daily to placebo in pediatric patients 12 to 17 years of age with major depressive disorder [see Clinical Studies (14.1)]. The safety of Lexapro was similar to adult patients with MDD [see Adverse Reactions (6.1)].

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

Generalized Anxiety Disorder

The safety and effectiveness of Lexapro for the treatment of generalized anxiety disorder have been established in pediatric patients 7 years of age and older. Use of Lexapro for this indication is supported by evidence from adequate and well-controlled studies in adults with additional evidence from an 8-week, flexible-dose, placebo-controlled study that compared Lexapro 10 mg to 20 mg once daily to placebo in pediatric patients 7 to 17 years of age with GAD [see Clinical Studies (14.2)]. The safety of Lexapro was similar to adult patients with GAD [see Adverse Reactions (6.1)].

The safety and effectiveness of Lexapro for the treatment of generalized anxiety disorder have not been established in pediatric patients younger than 7 years of age.

Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see Warnings and Precautions (5.1)]. 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.

Juvenile Animal Toxicity Data

In a juvenile animal study, male and female rats were administered escitalopram at 5, 40, or 80 mg/kg/day by oral gavage from postnatal day (PND) 21 to PND 69. A delay in sexual maturation was observed in both males and females at ≥ 40 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 5 mg/kg/day. This NOAEL was associated with plasma AUC levels less than those measured at the maximum recommended dose (MRHD) in pediatrics (20 mg). However, there was no effect on reproductive function. Increased motor activity (both ambulatory and fine movements) was observed in females prior to daily dosing at ≥ 40 mg/kg/day (3.5 times the MRHD based on AUC levels). A reversible disruption of learning and memory function was observed in males at 80 mg/kg/day with a NOAEL of 40 mg/kg/day, which was associated with an AUC level 3.5 times those measured at the MRHD in pediatrics. There was no effect on learning and memory function in treated female rats.

8.5****Geriatric Use

Approximately 69 patients (6%) of the 1,144 patients receiving escitalopram in controlled trials of Lexapro in major depressive disorder and GAD were 60 years of age or older [see Clinical Studies (14.1, 14.2)]. 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.

In two pharmacokinetic studies, escitalopram half-life was increased by approximately 50% in subjects 65 years and older as compared to young subjects and Cmax was unchanged [see Clinical Pharmacology (12.3)]. The recommended dosage of LEXAPRO for elderly patients is 10 mg daily [see Dosage and Administration (2.5)].

SSRIs, including Lexapro, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.6)].

Of 4,422 patients in clinical studies of racemic citalopram, 1,357 were 60 and over, 1,034 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 geriatric and younger patients, but again, greater sensitivity of some elderly individuals cannot be ruled out.

8.6****Hepatic Impairment

Increased citalopram exposure occurs in patients with hepatic impairment [see Clinical Pharmacology (12.3)]. The recommended dosage of LEXAPRO in patients with hepatic impairment is 10 mg daily [see Dosage and Administration (2.5)].

8.7****Renal Impairment

Pharmacokinetics of Lexapro in patients with a creatinine clearance less than 20 mL/minute has not been evaluated. No dosage adjustment is necessary for patients with mild or moderate renal impairment [see Dosage and Administration (2.5), Clinical Pharmacology (12.3)].

14****CLINICAL STUDIES

14.1****Major Depressive Disorder

Adults
The efficacy of Lexapro 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 daily Lexapro and 20 mg daily Lexapro to placebo and 40 mg daily citalopram. The 10 mg daily and 20 mg daily Lexapro treatment groups showed statistically significant greater mean improvement compared to placebo on the MADRS. The 10 mg and 20 mg Lexapro groups were similar on this outcome measure.

In a second fixed-dose study of 10 mg daily Lexapro and placebo, the 10 mg daily Lexapro treatment group showed statistically significant greater mean improvement compared to placebo on the MADRS.

In a flexible-dose study, comparing Lexapro, titrated between 10 mg and 20 mg daily, to placebo and citalopram, titrated between 20 mg and 40 mg daily, the Lexapro 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 10 mg or 20 mg daily, were randomized to continuation of Lexapro 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 experienced a statistically significant longer time to relapse compared to those receiving placebo.

Pediatric Patients 12 years of age and older

The efficacy of Lexapro as a treatment for major depressive disorder in pediatric patients 12 to 17 years was established in an 8-week, flexible-dose, placebo-controlled study that compared Lexapro (10 mg to 20 mg daily) to placebo in outpatients 12 to 17 years of age inclusive who met DSM-IV criteria for major depressive disorder (MDD). The primary outcome was change from baseline to endpoint in the Children’s Depression Rating Scale - Revised (CDRS-R). In this study, Lexapro showed statistically significant greater mean improvement compared to placebo on the CDRS-R.

The efficacy of Lexapro in the treatment of major depressive disorder in pediatric patients 12 to 17 years was established, in part, on the basis of extrapolation from the 8-week, flexible-dose, placebo-controlled study with racemic citalopram 20 mg to 40 mg daily. In this outpatient study in pediatric patients 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 12 to 17 year subgroup.

Two additional flexible-dose, placebo-controlled MDD studies (one Lexapro study in patients ages 7 to 17 years and one citalopram study patients 13 to 18 years) did not demonstrate efficacy. The safety and effectiveness of Lexapro have not been established in pediatric patients less than 12 years of age with MDD.

14.2****Generalized Anxiety Disorder

Adults

The efficacy of Lexapro in the treatment of generalized anxiety disorder (GAD) in adults was demonstrated in three, 8-week, multicenter, flexible-dose, placebo-controlled studies that compared Lexapro (10 mg to 20 mg daily) to placebo in outpatients between 18 and 80 years of age who met DSM-IV criteria for GAD. In all three studies, Lexapro 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 has differential effects in these groups. There was no difference in response to Lexapro between men and women.

Pediatric Patients 7 years of age and older

The efficacy of Lexapro in the treatment for generalized anxiety disorder (GAD) in pediatric patients 7 to 17 years was established in an 8-week, flexible-dose, placebo-controlled study that compared Lexapro (10 mg to 20 mg daily) to placebo in outpatients 7 to 17 years of age who met DSM-V criteria for GAD. The primary outcome was change from baseline to Week 8 in the Pediatric Anxiety Rating Scale (PARS) severity score for GAD. In this study, Lexapro showed a statistically significant treatment difference when compared to placebo on the PARS severity score for GAD (Least squares mean difference: −1.42, 95% confidence interval [−2.69, −0.15]).

MEDICATION GUIDE Lexapro**®**** (leks-a-pro)** (escitalopram) tablets ** oral solution**
What is the most important information I should know about Lexapro? Lexapro may cause serious side effects, including: *Increased risk of suicidal thoughts or actions.Lexapro and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger,especially within the first few months of treatment or when the dose is changed. ○Depression or other mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? **○**Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. ○ Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your child develop suicidal thoughts or actions. ○ Keep all follow-up visits with your healthcare provider as scheduled and call your healthcare provider between visits if you are worried about symptoms. Call your healthcare provider or get emergency medical help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you:
attempts to commit suicide	acting on dangerous impulses
acting aggressive, being angry or violent	thoughts about suicide or dying
new or worse depression	new or worsening anxiety
panic attacks	feeling very agitated or restless
new or worse irritability	trouble sleeping
an extreme increase in activity or talking (mania)	other unusual changes in behavior or mood
What is Lexapro? Lexapro is a prescription medicine used to treat: a certain type of depression called Major Depressive Disorder (MDD) in adults and children 12 years of age and older Generalized Anxiety Disorder (GAD) in adults and children 7 years of age and older It is not known if Lexapro is safe and effective for use in children under 12 years of age with MDD or children under 7 years of age with GAD.
Do not take Lexapro if you or your child: are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue are taking the antipsychotic medicine pimozide are allergic to escitalopram or citalopram or any of the ingredients in Lexapro. See the end of this Medication Guide for a complete list of ingredients in Lexapro. Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Lexapro.
Before taking Lexapro, tell your healthcare provider about all your medical conditions, including if you or your child: have or had seizures or convulsions have, or have a family history of bipolar disorder, mania, or hypomania have low blood sodium levels have or had bleeding problems have high pressure in the eye (glaucoma) have heart, liver, or kidney problems are pregnant or plan to become pregnant. Lexapro may harm the unborn baby. Taking Lexapro during the third trimester of pregnancy may cause the baby to have withdrawal symptoms, or breathing, temperature control, feeding, or other problems after birth. Talk to your healthcare provider about the risks to the baby if you or your child take Lexapro during pregnancy. ○ Tell your healthcare provider right away if you or your child become pregnant or think you may be pregnant during treatment with Lexapro. ○ There is a pregnancy registry for females who are exposed to Lexapro during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Lexapro and their baby. If you or your child become pregnant during treatment with Lexapro, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research- programs/pregnancyregistry/antidepressants/. are breastfeeding or plan to breastfeed. Lexapro passes into breast milk and may harm the baby. Talk to your healthcare provider about the best way to feed the baby during treatment with Lexapro. ○ If you or your child breastfeed during treatment with Lexapro, call your healthcare provider if the baby develops sleepiness or fussiness, or is not feeding or gaining weight well. Tell your healthcare provider about all the medicines you or your child take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Lexapro and some medicines may affect each other and may cause serious side effects. Lexapro may affect the way other medicines work and other medicines may affect the way Lexapro works. Especially tell your healthcare provider if you take: medicines used to treat migraine headache known as triptans tricyclic antidepressants lithium tramadol, fentanyl, meperidine, methadone, or other opioids tryptophan buspirone amphetamines St. John’s Wort medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) diuretics medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin Ask your healthcare provider if you are not sure if you or your child are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Lexapro with your other medicines. Do not start or stop any other medicines during treatment with Lexapro without talking to your healthcare provider first. Stopping Lexapro suddenly may cause you or your child to have serious side effects. See,** “What are the possible side effects of Lexapro?”** Know the medicines you or your child take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine.
How should I take Lexapro? Take Lexapro exactly as prescribed. Your healthcare provider may need to change the dose of Lexapro until it is the right dose for you or your child. Take Lexapro 1 time each day, in the morning or the evening. Take Lexapro with or without food. If you or your child take too much Lexapro, call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What should I avoid while taking Lexapro? *Do not drive, operate heavy machinery, or do other dangerous activities until you know how Lexapro affects you. Lexapro can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. *Do not drink alcohol during treatment with Lexapro.
What are the possible side effects of Lexapro? Lexapro****may cause serious side effects, including: See** “What is the most important information I should know about Lexapro?”** ***Serotonin syndrome.A potentially life-threatening problem called serotonin syndrome can happen when Lexapro is taken with certain other medicines. See“Do not take Lexapro if you?”**Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome:
agitation	seeing or hearing things that are not real (hallucinations)
confusion	coma
fast heartbeat	blood pressure changes
sweating	shaking (tremors), stiff muscles, or muscle twitching
flushing	dizziness
seizures	high body temperature (hyperthermia)
nausea, vomiting, diarrhea	loss of coordination
***Discontinuation syndrome.**Suddenly stopping Lexapro may cause you or your child to have serious side effects. Your healthcare provider may want to decrease the dose slowly. Symptoms may include:
changes in mood	headache
irritability and agitation	tiredness
dizziness	problems sleeping
electric shock sensation (paresthesia)	hypomania
anxiety	ringing in your ears (tinnitus)
confusion	seizures
*Seizures (convulsions).
***Manic episodes.**Manic episodes may happen in people with bipolar disorder who take Lexapro. Symptoms may include:
greatly increased energy	severe trouble sleeping
racing thoughts	reckless behavior
unusually grand ideas	excessive happiness or irritability
talking more or faster than usual
*Low sodium levels in the blood (hyponatremia). Low sodium levels in the blood that may be serious and may cause death can happen during treatment with Lexapro.****Elderly people and people who take certain medicines may be at greater risk for developing low sodium levels in the blood. Signs and symptoms may include:
headache	problems concentrating or thinking
weakness or feeling unsteady which can lead to falls	confusion
memory problems
In more severe or more sudden cases, signs and symptoms include:
seeing or hearing things that are not real (hallucinations)	fainting
seizures	coma
stopping breathing (respiratory arrest)
*Increased risk of bleeding:**Taking**Lexapro with aspirin, NSAIDS, warfarin, or other blood thinners may add to this risk. Tell your healthcare provider if you have any unusual bleeding or bruising.
*Visual problems (angle-closure glaucoma). Lexapro may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems.****You or your child may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you or your child have:
eye pain	changes in vision	swelling or redness in or around the eye
***Sexual problems (dysfunction).**Taking Lexapro may cause sexual problems. Symptoms in males may include:
delayed ejaculation or inability to have an ejaculation	decreased sex drive
problems getting or keeping an erection
Symptoms in females may include:
decreased sex drive	delayed orgasm or inability to have an orgasm
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Lexapro. There may be treatments your healthcare provider can suggest.
The most common side effects of Lexapro include:
trouble sleeping	sweating	decreased sex drive
delayed ejaculation nausea	tiredness sleepiness	delayed orgasm or inability to have an orgasm
Height and weight changes in children may happen during treatment with Lexapro. Your child’s height and weight should be monitored during treatment with LEXAPRO. These are not all the possible side effects of Lexapro. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Lexapro? Store Lexapro at room temperature between 68°F to 77°F (20°C to 25°C). *Keep Lexapro and all medicines out of the reach of children.
General information about the safe and effective use of Lexapro. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lexapro for a condition for which it was not prescribed. Do not give Lexapro to other people, even if they have the same symptoms that you have. It may harm them. You may ask your pharmacist or healthcare provider for information about Lexapro that is written for health professionals.
What are the ingredients in Lexapro? **Active ingredient:**escitalopram oxalate Inactive ingredients: Tablets: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol Oral solution: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor Distributed by: AbbVie Inc. 1 N Waukegan Rd. North Chicago, IL 60064 Licensed from H. Lundbeck A/S ©2023 AbbVie. All rights reserved. LEXAPRO and its design are trademarks of H. Lundbeck A/S, used under license by AbbVie. For more information about Lexapro, call 1-800-678-1605 or go to www.Lexapro.com

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 9/2023

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16****HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Tablets

5 mg Tablets:

Bottle of 100 NDC # 0456-2005-01

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 100 NDC # 0456-2010-01

10 x 10 Unit Dose NDC # 0456-2010-63

White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "10".

20 mg Tablets:

Bottle of 100 NDC # 0456-2020-01

10 x 10 Unit Dose NDC # 0456-2020-63

White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "20".

Oral Solution

5 mg/5 mL, peppermint flavor (240 mL) NDC # 0456-2101-08. The oral solution is not currently being marketed.

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15 to 30°C (59° to 86°F).

17****PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors

Advise patients, their families and caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].

Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the with the concomitant use of Lexapro with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, 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). Instruct patients to contact their health care provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)].

Discontinuation Syndrome

Advise patients not to abruptly discontinue Lexapro and to discuss any tapering regimen with their healthcare provider. Inform patients that adverse reactions can occur when Lexapro is discontinued [see Warnings and Precautions (5.3)].

Activation of Mania or Hypomania
Advise patients and their caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions (5.5)].

Increased Risk of Bleeding

Inform patients about the concomitant use of Lexapro with NSAIDs, aspirin, warfarin, other antiplatelet drugs, or other anticoagulants because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their healthcare providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions (5.7)].

Angle Closure Glaucoma
Advise patients 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 (5.9)].

Sexual Dysfunction
Advise patients that use of Lexapro may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.11)].

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.

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.

Alcohol
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
Advise pregnant women to notify their healthcare providers if they become pregnant or intend to become pregnant during treatment with LEXAPRO.

Advise patients that LEXAPRO use later in pregnancy may lead to increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, tube feeding, and/or persistent pulmonary hypertension (PPHN) of the newborn [see Use in Specific Populations (8.1)].

Advise women that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LEXAPRO during pregnancy [see Use in Specific Populations (8.1)].

Lactation
Advise breastfeeding women using LEXAPRO to monitor infants for excess sedation, restlessness, agitation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].

Distributed by:
Abbvie Inc.
1 N Waukegan Rd.
North Chicago, IL 60064

Licensed from H. Lundbeck A/S
©2023 AbbVie. All rights reserved.
LEXAPRO and its design are trademarks of H. Lundbeck A/S, used under license by AbbVie.
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