ESCITALOPRAM OXALATE tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ESCITALOPRAM OXALATE (UNII: 5U85DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)
Available from:
Proficient Rx LP
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1) ]. 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. Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see   Clinical   Studies   ( 14.2)
Product summary:
Escitalopram tablets, USP 5 mg are white to off-white, round, biconvex, film coated tablets debossed with '135' on one side and '5' on other side. Bottles of 30                                           NDC 71205-313-30 Bottles of 60                                          NDC 71205-313-60 Bottles of 90                                          NDC 71205-313-90 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
71205-313-30, 71205-313-60, 71205-313-90

ESCITALOPRAM OXALATE- escitalopram oxalate tablet

Proficient Rx LP

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Medication Guide

Escitalopram (EE sye TAL o pram) Tablets, USP

Read the Medication Guide that comes with escitalopram tablets before you start taking it and each time you

get a refill. There may be new information. This Medication Guide does not take the place of talking to your

healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is

something you do not understand or want to learn more about.

What is the most important information I should know about escitalopram tablets?

Escitalopram tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Escitalopram tablets and other antidepressant medicines may increase suicidal thoughts or

actions in some children, teenagers, or young adults within the first few months of treatment or

when the dose is changed.

Depression or other serious mental illnesses are the most important causes of suicidal thoughts or

actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Pay particular attention to such changes when escitalopram tablets are started or when the dose is

changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about

symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if

an emergency, especially if they are new, worse, or worry you:

attempts to commit suicide

acting on dangerous impulses

acting aggressive or violent

thoughts about suicide or dying

new or worse depression

new or worse anxiety or panic attacks

feeling agitated, restless, angry or irritable

trouble sleeping

an increase in activity or talking more than what is normal for you

other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if

an emergency. Escitalopram tablets may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

agitation, hallucinations, coma or other changes in mental status

coordination problems or muscle twitching (overactive reflexes)

racing heartbeat, high or low blood pressure

sweating or fever

nausea, vomiting, or diarrhea

muscle rigidity

3. Severe allergic reactions:

trouble breathing

swelling of the face, tongue, eyes or mouth

rash, itchy welts (hives) or blisters, alone or with fever or joint pain

4. Abnormal bleeding: Escitalopram tablets and other antidepressant medicines may increase your risk of

bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ®, Jantoven ®), a non-

steroidal antiinflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. Manic episodes:

greatly increased energy

severe trouble sleeping

racing thoughts

reckless behavior

unusually grand ideas

excessive happiness or irritability

talking more or faster than usual

7. Changes in appetite or weight. Children and adolescents should have height and weight monitored

during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may

include:

headache

weakness or feeling unsteady

confusion, problems concentrating or thinking or memory problems

9. Visual problems

eye pain

changes in vision

swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you

are at risk and receive preventative treatment if you are.

Do not stop escitalopram tablets without first talking to your healthcare provider. Stopping

escitalopram tablets too quickly may cause serious symptoms including:

anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

headache, sweating, nausea, dizziness

electric shock-like sensations, shaking, confusion

What are escitalopram tablets?

Escitalopram tablets are a prescription medicine used to treat depression. It is important to talk with your

healthcare provider about the risks of treating depression and also the risks of not treating it. You should

discuss all treatment choices with your healthcare provider. Escitalopram tablets are also used to treat:

Major Depressive Disorder (MDD)

Generalized Anxiety Disorder (GAD)

Talk to your healthcare provider if you do not think that your condition is getting better with escitalopram

tablets treatment.

Who should not take escitalopram tablets?

Do not take escitalopram tablets if you:

are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets. See the end

of this Medication Guide for a complete list of ingredients in escitalopram tablets.

Take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or a pharmacist if you are

not sure if you take an MAOI, including linezolid.

Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your

physician

Do not start escitalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed to

do so by your physician.

People who take escitalopram tablets close in time to an MAOI may have serious or even life-

threatening side effects. Get medical help right away if you have any of these symptoms:

○ high fever

○ uncontrolled muscle spasms

○ stiff muscles

○ rapid changes in heart rate or blood pressure

○ confusion

○ loss of consciousness (pass out)

Do not take escitalopram tablets with Orap ®(pimozide) because taking these two drugs together can

cause serious heart problems.

What should I tell my healthcare provider before taking escitalopram tablets? Ask if you are not

sure.

Before starting escitalopram tablets, tell your healthcare provider if you:

Are taking certain drugs such as:

Triptans used to treat migraine headache

Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium,

SSRIs, SNRIs, amphetamines or antipsychotics

tramadol

Over-the-counter supplements such as tryptophan or St. John's Wort

have liver problems

have kidney problems

have heart problems

have or had seizures or convulsions

have bipolar disorder or mania

have low sodium levels in your blood

have a history of a stroke

have high blood pressure

have or had bleeding problems

are pregnant or plan to become pregnant. It is not known if escitalopram tablets will harm your unborn

baby. Talk to your healthcare provider about the benefits and risks of treating depression during

pregnancy

are breast-feeding or plan to breast-feed. Some escitalopram may pass into your breast milk. Talk to

your healthcare provider about the best way to feed your baby while taking escitalopram tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-

prescription medicines, vitamins, and herbal supplements. Escitalopram tablets and some medicines may

interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take escitalopram tablets with your other

medicines. Do not start or stop any medicine while taking escitalopram tablets without talking to your

healthcare provider first.

If you take escitalopram tablets, you should not take any other medicines that contain escitalopram or

citalopram including: Celexa.

How should I take escitalopram tablets?

Take escitalopram tablets exactly as prescribed. Your healthcare provider may need to change the

dose of escitalopram tablets until it is the right dose for you.

Escitalopram tablets may be taken with or without food.

If you miss a dose of escitalopram tablets, take the missed dose as soon as you remember. If it is

almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not

take two doses of escitalopram tablets at the same time.

If you take too much escitalopram tablets, call your healthcare provider or poison control center right

away, or get emergency treatment.

What should I avoid while taking escitalopram tablets?

Escitalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react

quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how

escitalopram tablets affect you. Do not drink alcohol while using escitalopram tablets.

What are the possible side effects of escitalopram tablets?

Escitalopram tablets may cause serious side effects, including all of those described in the section entitled

"What is the most important information I should know about escitalopram tablets?"

Common possible side effects in people who take escitalopram tablets include :

Nausea

Sleepiness

Weakness

Dizziness

Feeling anxious

Trouble sleeping

Sexual problems

Sweating

Shaking

Not feeling hungry

Dry mouth

Constipation

Infection

Yawning

Other side effects in children and adolescents include:

increased thirst

abnormal increase in muscle movement or agitation

nose bleed

difficult urination

heavy menstrual periods

possible slowed growth rate and weight change. Your child's height and weight should be monitored

during treatment with escitalopram tablets.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are

not all the possible side effects of escitalopram tablets. For more information, ask your healthcare provider or

pharmacist.

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 escitalopram tablets?

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

86°F) [see USP Controlled Room Temperature].

Keep escitalopram tablets bottle closed tightly.

Keep escitalopram tablets and all medicines out of the reach of children.

General information about escitalopram tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

escitalopram tablets for a condition for which it was not prescribed. Do not give escitalopram tablets to other

people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about escitalopram tablets. If you would

like more information, talk with your healthcare provider. You may ask your healthcare provider or

pharmacist for information about escitalopram tablets that is written for healthcare professionals.

For more information about escitalopram tablets call 1-800-912-9561.

What are the ingredients in escitalopram tablets?

Active ingredient: escitalopram oxalate, USP

Inactive ingredients:

Tablets : cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium

stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and

titanium dioxide.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

Repackaged by:

PROFICIENT RX LP, Thousand Oaks, CA 91320.

8075449 Revised June 2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 3/2020

Document Id: 6542d443-5a49-4e63-9c2a-aaf099daab07

34391-3

Set id: e773030f-d07d-4bb8-9dc9-6f649688346d

Version: 3

Effective Time: 20200301

Proficient Rx LP

ESCITALOPRAM OXALATE- escitalopram oxalate tablet

Proficient Rx LP

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use escitalopram tablets safely and effectively.

See full prescribing information for escitalopram tablets.

ESCITALOPRAM tablets USP, for oral use

Initial U.S. Approval: 2002

WARNING: SUICIDALITY and ANTIDEPRESSANT DRUGS

See full prescribing information for complete boxed warning.

Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking

antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Escitalopram

tablets are not approved for use in pediatric patients less than 12 years of age (5.1).

INDICATIONS AND USAGE

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for:

DOSAGE AND ADMINISTRATION

Escitalopram tablets should generally be administered once daily, morning or evening with or without

food ( 2.1, 2.2).

Indication

Recommended Dose

MDD in Adolescents ( 2.1)

Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

MDD in Adults ( 2.1)

Initial: 10 mg once daily

Recommended: 10 mg once daily

Maximum: 20 mg once daily

GAD in Adults ( 2.2)

Initial: 10 mg once daily

Recommended: 10 mg once daily

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12

to 17 years ( 1.1)

Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2)

No additional benefits seen at 20 mg/day dose ( 2.1).

10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment ( 2.3).

No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal

impairment ( 2.3).

Discontinuing escitalopram tablets: A gradual dose reduction is recommended ( 2.4).

Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) ( 3.1)

Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with escitalopram or

within 14 days of stopping treatment with escitalopram. Do not use escitalopram within 14 days of stopping an MAOI

intended to treat psychiatric disorders. In addition, do not start escitalopram in a patient who is being treated with

linezolid or intravenous methylene blue ( 4.1).

Pimozide: Do not use concomitantly ( 4.2).

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are:

insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence,

decreased libido, and anorgasmia ( 6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-

800-FDA-1088, or www.fda.gov/medwatch .

DRUG INTERACTIONS

Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended ( 7.2).

Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) ( 7.6).

USE IN SPECIFIC POPULATIONS

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1). (8)

Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3) (8)

Pediatric Use: Safety and effectiveness of escitalopram oxalate has not been established in pediatric MDD patients less

than 12 years of age (8.4). (8)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 3/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SUICIDALITY and ANTIDEPRESSANT DRUGS

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder

1.2 Generalized Anxiety Disorder

2 DOSAGE AND ADMINISTRATION

2.1 Major Depressive Disorder

2.2 Generalized Anxiety Disorder

2.3 Special Populations

2.4 Discontinuation of Treatment with Escitalopram Tablets

2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat

Psychiatric Disorders

2.6 Use of Escitalopram Tablet with Other MAOIs such as Linezolid or Methylene Blue

Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients ( 4.3).

Clinical Worsening/Suicide Risk: Monitor for clinical worsening, suicidality and unusual change in behavior, especially,

during the initial few months of therapy or at times of dose changes ( 5.1).

Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram, both

when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic

antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such

symptoms occur, discontinue escitalopram and initiate supportive treatment. If concomitant use of escitalopram with

other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for

serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2).

Discontinuation of Treatment with Escitalopram: A gradual reduction in dose rather than abrupt cessation is

recommended whenever possible ( 5.3).

Seizures: Prescribe with care in patients with a history of seizure ( 5.4).

Activation of Mania/Hypomania: Use cautiously in patients with a history of mania ( 5.5).

Hyponatremia: Can occur in association with SIADH ( 5.6)

Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect

coagulation ( 5.7).

Interference with Cognitive and Motor Performance: Use caution when operating machinery ( 5.8).

Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles

treated with antidepressants. ( 5.9)

Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered

metabolism or hemodynamic responses ( 5.10).

3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets

4 CONTRAINDICATIONS

4.1 Monoamine oxidase inhibitors (MAOIs)

4.2 Pimozide

4.3 Hypersensitivity to escitalopram or citalopram

5 WARNINGS AND PRECAUTIONS

5.1 Clinical Worsening and Suicide Risk

5.2 Serotonin Syndrome

5.3 Discontinuation of Treatment with Escitalopram Tablets

5.4 Seizures

5.5 Activation of Mania/Hypomania

5.6 Hyponatremia

5.7 Abnormal Bleeding

5.8 Interference with Cognitive and Motor Performance

5.9 Angle Closure Glaucoma

5.10 Use in Patients with Concomitant Illness

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors (MAOIs)

7.2 Serotonergic Drugs

7.3 Triptans

7.4 CNS Drugs

7.5 Alcohol

7.6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)

7.7 Cimetidine

7.8 Digoxin

7.9 Lithium

7.10 Pimozide and Celexa

7.11 Sumatriptan

7.12 Theophylline

7.13 Warfarin

7.14 Carbamazepine

7.15 Triazolam

7.16 Ketoconazole

7.17 Ritonavir

7.18 CYP3A4 and -2C19 Inhibitors

7.19 Drugs Metabolized by Cytochrome P4502D6

7.20 Metoprolol

7.21 Electroconvulsive Therapy (ECT)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse and Dependence

10 OVERDOSAGE

10.1 Human Experience

10.2 Management of Overdose

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

14.2 Generalized Anxiety Disorder

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Tablets

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

FULL PRESCRIBING INFORMATION

WARNING: SUICIDALITY and ANTIDEPRESSANT DRUGS

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

escitalopram tablets 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. Escitalopram tablets

are not approved for use in pediatric patients less than 12 years of age. [See Warnings and

Precautions: Clinical Worsening and Suicide Risk ( 5.1), Patient Counseling Information:

Information for Patients ( 17.1), and Use in Specific Populations: Pediatric Use ( 8.4)].

1 INDICATIONS AND USAGE

1.1 Major Depressive Disorder

Escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder

in adults and in adolescents 12 to 17 years of age [ see Clinical Studies ( 14.1) ].

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.

Sections or subsections omitted from the full prescribing information are not listed.

1.2 Generalized Anxiety Disorder

Escitalopram tablets are indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in

adults [ see Clinical Studies ( 14.2) ].

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.

2 DOSAGE AND ADMINISTRATION

Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.

2.1 Major Depressive Disorder

Initial Treatment

Adoles cents

The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of

escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [ see

Clinical Studies ( 14.1) ]. If the dose is increased to 20 mg, this should occur after a minimum of three

weeks.

Adults

The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram

demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram, but failed to demonstrate a

greater benefit of 20 mg over 10 mg [ see Clinical Studies ( 14.1) ]. 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 escitalopram 10 or 20 mg/day in adults patients with major depressive disorder

who responded while taking escitalopram during an 8-week, acute-treatment phase demonstrated a

benefit of such maintenance treatment [ see Clinical Studies ( 14.1)]. Nevertheless, the physician who

elects to use escitalopram 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.

2.2 Generalized Anxiety Disorder

Initial Treatment

Adults

The recommended starting dose of escitalopram tablets 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 escitalopram in the

treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use

escitalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug

for the individual patient.

2.3 Special Populations

10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram

tablets should be used with caution in patients with severe renal impairment.

2.4 Discontinuation of Treatment with Escitalopram Tablets

Symptoms associated with discontinuation of escitalopram tablets 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.

2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat

Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric

disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be

allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric

disorders [see Contraindications ( 4.1) ].

2.6 Use of Escitalopram Tablet with Other MAOIs such as Linezolid or Methylene Blue

Do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous

methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more

urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be

considered [ see Contraindications ( 4.1) ].

In some cases, a patient already receiving escitalopram tablets therapy may require urgent treatment with

linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene

blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue

treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram

tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered.

The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours

after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with

escitalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene

blue [ see Warnings and Precautions ( 5.2) ].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local

injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets is unclear. The

clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome

with such use [ see Warnings and Precautions ( 5.2) ].

3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets

Escitalopram tablets, USP 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. 5 mg

tablets are debossed with '135' on one side and '5' on other side. 10 mg tablets are debossed with break

line on one side, separating '11' and '36' on one side, and '10' on other side. 20 mg tablets are debossed

with break line on one side, separating '11' and '37' on one side, and '20' on other side.

4 CONTRAINDICATIONS

4.1 Monoamine oxidase inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with escitalopram tablets or within 14 days of

stopping treatment with escitalopram tablets is contraindicated because of an increased risk of serotonin

syndrome. The use of escitalopram tablets within 14 days of stopping an MAOI intended to treat

psychiatric disorders is also contraindicated [ see Dosage and Administration ( 2.5), and Warnings and

Precautions ( 5.2) ].

Starting escitalopram tablets in a patient who is being treated with MAOIs such as linezolid or

intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [

see Dosage and Administration ( 2.6), and Warnings and Precautions ( 5.2) ].

4.2 Pimozide

Concomitant use in patients taking pimozide is contraindicated [ see Drug Interactions ( 7.10) ].

4.3 Hypersensitivity to escitalopram or citalopram

Escitalopram tablets are contraindicated in patients with a hypersensitivity to escitalopram or citalopram

or any of the inactive ingredients in escitalopram tablets.

5 WARNINGS AND PRECAUTIONS

5.1 Clinical Worsening and Suicide Risk

Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of

their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes

in behavior, whether or not they are taking antidepressant medications, and this risk may persist until

significant remission occurs. Suicide is a known risk of depression and certain other psychiatric

disorders, and these disorders themselves are the strongest predictors of suicide. There has been a

longstanding concern, however, that antidepressants may have a role in inducing worsening of

depression and the emergence of suicidality in certain patients during the early phases of treatment.

Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others)

showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children,

adolescents, and young adults (ages 18 to 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 4,400 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 1,000 patients treated) are provided in Table 1.

TABLE 1

Age Range

Drug-Placebo Difference in Number of Cases of Suicidality per

1,000 Patients Treated

Increases Compared to Placebo

<18

14 additional cases

18 to 24

5 additional cases

Decreases Compared to Placebo

25 to 64

1 fewer case

≥65

6 fewer case

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the

number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months.

However, there is substantial evidence from placebo-controlled maintenance trials in adults with

depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and

observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially

during the initial few months of a course of drug therapy, or at times of dose changes, either increases

or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility,

aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been

reported in adult and pediatric patients being treated with antidepressants for major depressive disorder

as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the

emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal

impulses has not been established, there is concern that such symptoms may represent precursors to

emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing

the medication, in patients whose depression is persistently worse, or who are experiencing emergent

suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if

these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is

feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms [ see

Dosage and Administration ( 2.4) ].

Families and caregivers of patients being treated with antidepressants for major depressive disorder or

other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor

patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms

described above, as well as the emergence of suicidality, and to report such symptoms immediately to

health care providers. Such monitoring should include daily observation by families and caregivers [

see also Patient Counseling Information ( 17.1) ]. Prescriptions for escitalopram tablets 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 escitalopram is not approved for use in treating bipolar depression.

5.2 Serotonin Syndrome

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and

SSRIs, including escitalopram, alone but particularly with concomitant use of other serotonergic drugs

(including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone,

amphetamines, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular,

MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and

intravenous methylene blue).

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations,

delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness,

diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus,

hyperreflexia, incoordination) seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting,

diarrhea). Patients should be monitored for the emergence of serotonin syndrome.

The concomitant use of escitalopram with MAOIs intended to treat psychiatric disorders is

contraindicated. Escitalopram should also not be started in a patient who is being treated with MAOIs

such as linezolid or intravenous methylene blue. All reports with methylene blue that provided

information on the route of administration involved intravenous administration in the dose range of 1

mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as

oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is

necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient

taking escitalopram. Escitalopram should be discontinued before initiating treatment with the MAOI [ see

Contraindications ( 4.1) and Dosage and Administration ( 2.5 and 2.6) ].

If concomitant use of escitalopram with other serotonergic drugs including, triptans, tricyclic

antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamine and St. John's Wort is

clinically warranted, patients should be made aware of a potential increased risk for serotonin

syndrome, particularly during treatment initiation and dose increases.

Treatment with escitalopram and any concomitant serotonergic agents, should be discontinued

immediately if the above events occur and supportive symptomatic treatment should be initiated.

5.3 Discontinuation of Treatment with Escitalopram Tablets

During marketing of escitalopram tablets 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 escitalopram. A

gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If

intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then

resuming the previously prescribed dose may be considered. Subsequently, the physician may continue

decreasing the dose but at a more gradual rate [ see Dosage and Administration ( 2.4) ].

5.4 Seizures

Although anticonvulsant effects of racemic citalopram have been observed in animal studies,

escitalopram 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

escitalopram, cases of convulsion have been reported in association with escitalopram treatment. Like

other drugs effective in the treatment of major depressive disorder, escitalopram tablets should be

introduced with care in patients with a history of seizure disorder.

5.5 Activation of Mania/Hypomania

In placebo-controlled trials of escitalopram in major depressive disorder, activation of mania/hypomania

was reported in one (0.1%) of 715 patients treated with escitalopram and in none of the 592 patients

treated with placebo. One additional case of hypomania has been reported in association with

escitalopram 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, escitalopram tablets should be used cautiously in patients with a history of

mania.

5.6 Hyponatremia

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including escitalopram. In many

cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone

secretion (SIADH), and was reversible when escitalopram was discontinued. Cases with serum sodium

lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing

hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume

depleted may be at greater risk [ see Geriatric Use ( 8.5)]. Discontinuation of escitalopram should be

considered in patients with symptomatic hyponatremia and appropriate medical intervention should be

instituted.

Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment,

confusion, weakness, and unsteadiness, which may lead to falls. Signs and symptoms associated with

more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest,

and death.

5.7 Abnormal Bleeding

SSRIs and SNRIs, including escitalopram, may increase the risk of bleeding events. Concomitant use of

aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to the risk.

Case reports and epidemiological studies (case-control and cohort design) have demonstrated an

association between use of drugs that interfere with serotonin reuptake and the occurrence of

gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs use have ranged from

ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.

Patients should be cautioned about the risk of bleeding associated with the concomitant use of

escitalopram and NSAIDs, aspirin, or other drugs that affect coagulation.

5.8 Interference with Cognitive and Motor Performance

In a study in normal volunteers, escitalopram 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 escitalopram tablets therapy does not affect their

ability to engage in such activities.

5.9 Angle Closure Glaucoma

Angle Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant

drugs including escitalopram may trigger an angle closure attack in a patient with anatomically narrow

angles who does not have a patent iridectomy.

5.10 Use in Patients with Concomitant Illness

Clinical experience with escitalopram in patients with certain concomitant systemic illnesses is limited.

Caution is advisable in using escitalopram tablets in patients with diseases or conditions that produce

altered metabolism or hemodynamic responses.

Escitalopram 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 escitalopram tablets in hepatically impaired

patients is 10 mg/day [ see Dosage and Administration ( 2.3) ].

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 escitalopram tablets, however, it should be used with caution in such

patients [ see Dosage and Administration ( 2.3) ].

6 ADVERSE REACTIONS

6.1 Clinical Trials 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

Pediatrics (6 to 17 years)

Adverse events were collected in 576 pediatric patients (286 escitalopram, 290 placebo) with major

depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of

escitalopram in pediatric patients less than 12 years of age has not been established.

Adults

Adverse events information for escitalopram 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 escitalopram 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 to 17 years)

Adverse events were associated with discontinuation of 3.5% of 286 patients receiving escitalopram

and 1% of 290 patients receiving placebo. The most common adverse event (incidence at least 1% for

escitalopram and greater than placebo) associated with discontinuation was insomnia (1% escitalopram,

0% placebo).

Adults

Among the 715 depressed patients who received escitalopram 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

escitalopram 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 escitalopram was 10%, which was significantly different from the rate of

discontinuation for adverse events in patients receiving 10 mg/day escitalopram (4%) and placebo (3%).

Adverse events that were associated with the discontinuation of at least 1% of patients treated with

escitalopram tablets, 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 escitalopram 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 events that were associated with the discontinuation of at least 1% of patients treated

with escitalopram, 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 to 17 years)

The overall profile of adverse reactions in pediatric patients 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 escitalopram and greater than placebo: back pain, urinary tract infection,

vomiting, and nasal congestion.

Adults

The most commonly observed adverse reactions in escitalopram 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 treatment-emergent adverse events

that occurred among 715 depressed patients who received escitalopram at doses ranging from 10 to 20

mg/day in placebo-controlled trials. Events included are those occurring in 2% or more of patients

treated with escitalopram and for which the incidence in patients treated with escitalopram was greater

than the incidence in placebo-treated patients.

TABLE 2

Treatment-Emergent Adverse Reactions observed with a frequency of 2% and

greater than placebo for

Major Depressive Disorder

Adverse Reaction

Escitalopram

Placebo

(N=715)

%

(N=592)

%

Autonomic Nervous System Disorders

Dry Mouth

Sweating Increased

Central & Peripheral Nervous System Disorders

Dizziness

Primarily ejaculatory delay.

Denominator used was for males only (N=225 escitalopram; N=188 placebo).

Denominator used was for females only (N=490 escitalopram; N=404 placebo).

Gastrointestinal Disorders

Nausea

Diarrhea

Constipation

Indigestion

Abdominal Pain

General

Influenza-like Symptoms

Fatigue

Psychiatric Disorders

Insomnia

Somnolence

Appetite Decreased

Libido Decreased

Respiratory System Disorders

Rhinitis

Sinusitis

Urogenital

Ejaculation Disorder

<1%

Impotence

<1%

Anorgasmia

<1%

Generalized Anxiety Disorder

Adults

The most commonly observed adverse reactions in escitalopram 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 events

that occurred among 429 GAD patients who received escitalopram 10 to 20 mg/day in placebo-

controlled trials. Events included are those occurring in 2% or more of patients treated with

escitalopram and for which the incidence in patients treated with escitalopram was greater than the

incidence in placebo-treated patients.

TABLE 3

Treatment-Emergent Adverse Reactions observed with a frequency of 2% and

greater than placebo for Generalized Anxiety Disorder

Adverse Reactions

Escitalopram

Placebo

(N=429)

%

(N=427)

%

Autonomic Nervous System Disorders

Dry Mouth

Sweating Increased

Central & Peripheral Nervous System Disorders

Headache

Primarily ejaculatory delay.

Denominator used was for males only (N=182 escitalopram; N=195 placebo).

Denominator used was for females only (N=247 escitalopram; N=232 placebo).

Paresthesia

Gastrointestinal Disorders

Nausea

Diarrhea

Constipation

Indigestion

Vomiting

Abdominal Pain

Flatulence

Toothache

General

Fatigue

Influenza-like Symptoms

Musculoskeletal System Disorder

Neck/Shoulder Pain

Psychiatric Disorders

Somnolence

Insomnia

Libido Decreased

Dreaming Abnormal

Appetite Decreased

Lethargy

Respiratory System Disorders

Yawning

Urogenital

Ejaculation Disorder

Anorgasmia

<1%

Menstrual Disorder

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 escitalopram groups) was examined on the basis of the combined incidence

of adverse reactions in two fixed-dose trials. The overall incidence rates of adverse events in 10 mg

escitalopram-treated patients (66%) was similar to that of the placebo-treated patients (61%), while the

incidence rate in 20 mg/day escitalopram-treated patients was greater (86%). Table 4 shows common

adverse reactions that occurred in the 20 mg/day escitalopram group with an incidence that was

approximately twice that of the 10 mg/day escitalopram 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)

Escitalopram

Escitalopram

(N=310)

(N=125)

Insomnia

Diarrhea

Dry Mouth

Somnolence

Dizziness

Sweating Increased

<1%

Constipation

Fatigue

Indigestion

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

Escitalopram

Placebo

In Males Only

(N=407)

(N=383)

Ejaculation Disorder

(primarily ejaculatory delay)

Libido Decreased

Impotence

<1%

In Females Only

(N=737)

(N=636)

Libido Decreased

Anorgasmia

<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

Escitalopram 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 escitalopram

treatment. In addition, a comparison of supine and standing vital sign measures in subjects receiving

escitalopram indicated that escitalopram treatment is not associated with orthostatic changes.

Weight Changes

Patients treated with escitalopram in controlled trials did not differ from placebo-treated patients with

regard to clinically important change in body weight.

Laboratory Changes

Escitalopram 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 escitalopram

treatment.

ECG Changes

Electrocardiograms from escitalopram (N=625) and placebo (N=527) groups were compared with

respect to outliers defined as subjects with QT

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 escitalopram group had a QT

F 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 escitalopram and the placebo group. The incidence of bradycardic outliers was 0.5% in the

escitalopram group and 0.2% in the placebo group.

F 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 QT

F change from placebo arm (95% confidence

interval) under the C

for the dose of 20 mg is 6.6 (7.9) msec. Escitalopram 30 mg given once daily

resulted in mean C

of 1.7-fold higher than the mean C

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.

Other Reactions Observed During the Premarketing Evaluation of Escitalopram Tablets

Following is a list of treatment-emergent adverse events, as defined in the introduction to the

ADVERSE REACTIONS section, reported by the 1,428 patients treated with escitalopram tablets 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 events already listed in Tables 2 & 3, those events for

which a drug cause was remote and at a rate less than 1% or lower than placebo, those events which

were so general as to be uninformative, and those events reported only once which did not have a

substantial probability of being acutely life threatening. Events are categorized by body system. Events

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 additional adverse reactions have been identified from spontaneous reports of

escitalopram received worldwide. These adverse reactions have been chosen for inclusion because of

a combination of seriousness, frequency of reporting, or potential causal connection to escitalopram and

have not been listed elsewhere in labeling. However, because these adverse reactions were 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. These events include:

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: dyspnea, epistaxis, pulmonary embolism, pulmonary

hypertension of the newborn.

Skin and Subcutaneous Tissue Disorders: alopecia, angioedema, dermatitis, 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

7.1 Monoamine Oxidase Inhibitors (MAOIs)

[See Dosage and Administration ( 2.5 and 2.6), Contraindications ( 4.1) and Warnings and Precautions (

5.2) ].

7.2 Serotonergic Drugs

[See Dosage and Administration ( 2.5 and 2.6), Contraindications ( 4.1) and Warnings and Precautions (

5.2) ].

7.3 Triptans

There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If

concomitant treatment of escitalopram with a triptan is clinically warranted, careful observation of the

patient is advised, particularly during treatment initiation and dose increases [ see Warnings and

Precautions ( 5.2) ].

7.4 CNS Drugs

Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination

with other centrally acting drugs.

7.5 Alcohol

Although escitalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as

with other psychotropic medications, the use of alcohol by patients taking escitalopram is not

recommended.

7.6 Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)

Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the

case-control and cohort design that have demonstrated an association between use of psychotropic

drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have

also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered

anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are

coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when

escitalopram is initiated or discontinued.

7.7 Cimetidine

In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of 400

mg twice a day cimetidine for 8 days resulted in an increase in citalopram AUC and C

of 43% and

39%, respectively. The clinical significance of these findings is unknown.

7.8 Digoxin

In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of

citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either

citalopram or digoxin.

7.9 Lithium

Coadministration of racemic citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days)

had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium

levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard

clinical practice. Because lithium may enhance the serotonergic effects of escitalopram, caution should

be exercised when escitalopram and lithium are coadministered.

7.10 Pimozide and Celexa

In a controlled study, a single dose of pimozide 2 mg co-administered with racemic citalopram 40 mg

given once daily for 11 days was associated with a mean increase in QT

values of approximately 10

msec compared to pimozide given alone. Racemic citalopram did not alter the mean AUC or C

pimozide. The mechanism of this pharmacodynamic interaction is not known.

7.11 Sumatriptan

There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and

incoordination following the use of an SSRI and sumatriptan. If concomitant treatment with sumatriptan

and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is clinically

warranted, appropriate observation of the patient is advised.

7.12 Theophylline

Combined administration of racemic citalopram (40 mg/day for 21 days) and the CYP1A2 substrate

theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of

theophylline on the pharmacokinetics of citalopram was not evaluated.

7.13 Warfarin

Administration of 40 mg/day racemic citalopram for 21 days did not affect the pharmacokinetics of

warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of

which is unknown.

7.14 Carbamazepine

Combined administration of racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to

400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4

substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing

properties of carbamazepine, the possibility that carbamazepine might increase the clearance of

escitalopram should be considered if the two drugs are coadministered.

7.15 Triazolam

Combined administration of racemic citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4

substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either

citalopram or triazolam.

7.16 Ketoconazole

Combined administration of racemic citalopram (40 mg) and ketoconazole (200 mg), a potent CYP3A4

inhibitor, decreased the C

and AUC of ketoconazole by 21% and 10%, respectively, and did not

significantly affect the pharmacokinetics of citalopram.

7.17 Ritonavir

Combined administration of a single dose of ritonavir (600 mg), both a CYP3A4 substrate and a potent

inhibitor of CYP3A4, and escitalopram (20 mg) did not affect the pharmacokinetics of either ritonavir or

escitalopram.

7.18 CYP3A4 and -2C19 Inhibitors

In vitro studies indicated that CYP3A4 and -2C19 are the primary enzymes involved in the metabolism

of escitalopram. However, coadministration of escitalopram (20 mg) and ritonavir (600 mg), a potent

inhibitor of CYP3A4, did not significantly affect the pharmacokinetics of escitalopram. Because

escitalopram is metabolized by multiple enzyme systems, inhibition of a single enzyme may not

appreciably decrease escitalopram clearance.

7.19 Drugs Metabolized by Cytochrome P4502D6

In vitro studies did not reveal an inhibitory effect of escitalopram on CYP2D6. In addition, steady state

levels of racemic citalopram were not significantly different in poor metabolizers and extensive

CYP2D6 metabolizers after multiple-dose administration of citalopram, suggesting that

coadministration, with escitalopram, of a drug that inhibits CYP2D6, is unlikely to have clinically

significant effects on escitalopram metabolism. However, there are limited in vivo data suggesting a

modest CYP2D6 inhibitory effect for escitalopram, i.e., 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 C

and a 100% increase in AUC of desipramine. The

clinical significance of this finding is unknown. Nevertheless, caution is indicated in the

coadministration of escitalopram and drugs metabolized by CYP2D6.

7.20 Metoprolol

Administration of 20 mg/day escitalopram tablets for 21 days in healthy volunteers resulted in a 50%

increase in C

and 82% increase in AUC of the beta-adrenergic blocker metoprolol (given in a

single dose of 100 mg). Increased metoprolol plasma levels have been associated with decreased

cardioselectivity. Coadministration of escitalopram and metoprolol had no clinically significant effects

on blood pressure or heart rate.

7.21 Electroconvulsive Therapy (ECT)

There are no clinical studies of the combined use of ECT and escitalopram.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

In a rat embryo/fetal development study, oral administration of escitalopram (56, 112, or 150 mg/kg/day)

to pregnant animals during the period of organogenesis resulted in decreased fetal body weight and

associated delays in ossification at the two higher doses (approximately ≥ 56 times the maximum

recommended human dose [MRHD] of 20 mg/day on a body surface area [mg/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 ≥ 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 escitalopram and other SSRIs or serotonin and norepinephrine reuptake inhibitors

(SNRIs), late in the third trimester, have developed complications requiring prolonged hospitalization,

respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature

instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor,

jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect

of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some

cases, the clinical picture is consistent with serotonin syndrome [ see Warnings and Precautions ( 5.2) ].

Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension

of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is

associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies

suggest a positive statistical association between SSRI use (including escitalopram) in pregnancy and

PPHN. Other studies do not show a significant statistical association.

Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with

a history of major depression, who were either on antidepressants or had received antidepressants less

than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued

antidepressant medication during pregnancy showed a significant increase in relapse of their major

depression compared to those women who remained on antidepressant medication throughout

pregnancy.

When treating a pregnant woman with escitalopram, the physician should carefully consider both the

potential risks of taking an SSRl, along with the established benefits of treating depression with an

antidepressant. This decision can only be made on a case by case basis [ see Dosage and Administration (

2.1) ].

8.2 Labor and Delivery

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

8.3 Nursing Mothers

Escitalopram is excreted in human breast milk. Limited data from women taking 10 to 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

escitalopram is administered to a nursing woman.

8.4 Pediatric Use

The safety and effectiveness of escitalopram have been established in adolescents (12 to 17 years of

age) for the treatment of major depressive disorder [ see Clinical Studies ( 14.1) ]. Although maintenance

efficacy in adolescent patients with major depressive disorder has not been systematically evaluated,

maintenance efficacy can be extrapolated from adult data along with comparisons of escitalopram

pharmacokinetic parameters in adults and adolescent patients.

The safety and effectiveness of escitalopram have not been established in pediatric (younger than 12

years of age) patients with major depressive disorder. In a 24-week, open-label safety study in 118

children (aged 7 to 11 years) who had major depressive disorder, the safety findings were consistent

with the known safety and tolerability profile for escitalopram.

Safety and effectiveness of escitalopram has not been established in pediatric patients less than 18 years

of age with Generalized Anxiety Disorder.

Decreased appetite and weight loss have been observed in association with the use of SSRIs.

Consequently, regular monitoring of weight and growth should be performed in children and

adolescents treated with an SSRI such as escitalopram.

8.5 Geriatric Use

Approximately 6% of the 1,144 patients receiving escitalopram in controlled trials of escitalopram in

major depressive disorder and GAD were 60 years of age or older; elderly patients in these trials

received daily doses of escitalopram 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 escitalopram

cannot be ruled out.

SSRIs and SNRIs, including escitalopram, have been associated with cases of clinically significant

hyponatremia in elderly patients, who may be at greater risk for this adverse event [ see Hyponatremia (

5.6) ].

In two pharmacokinetic studies, escitalopram half-life was increased by approximately 50% in elderly

subjects as compared to young subjects and C

was unchanged [ see Clinical Pharmacology ( 12.3) ].

10 mg/day is the recommended dose for elderly patients [ see Dosage and Administration ( 2.3) ].

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 elderly and younger patients, but again, greater sensitivity of some

elderly individuals cannot be ruled out.

9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse and Dependence

Physical and Psychological Dependence

Animal studies suggest that the abuse liability of racemic citalopram is low. Escitalopram has not been

systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The

premarketing clinical experience with escitalopram did not reveal any drug-seeking behavior. However,

these observations were not systematic and it is not possible to predict on the basis of this limited

experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once

marketed. Consequently, physicians should carefully evaluate escitalopram patients for history of drug

abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development

of tolerance, incrementations of dose, drug-seeking behavior).

10 OVERDOSAGE

10.1 Human Experience

In clinical trials of escitalopram, there were reports of escitalopram overdose, including overdoses of

up to 600 mg, with no associated fatalities. During the postmarketing evaluation of escitalopram,

escitalopram overdoses involving overdoses of over 1,000 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.

10.2 Management of 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 escitalopram.

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.

11 DESCRIPTION

Escitalopram tablets contain escitalopram oxalate, 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-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:

The molecular formula is C

O C

and the molecular weight is 414.40.

Escitalopram oxalate, USP 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.

Escitalopram oxalate, USP is available as tablets.

Escitalopram tablets, USP are white to off-white, round, biconvex, film-coated tablets containing 6.38

mg, 12.75 mg And 25.55 mg escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg,

respectively, of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the

following inactive ingredients: cellulose microcrystalline, colloidal silicon dioxide, croscarmellose

sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene

glycol 400 and titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

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).

12.2 Pharmacodynamics

In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake

inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram

is at least 100-fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and

inhibition of 5-HT neuronal firing rate. Tolerance to a model of antidepressant effect in rats was not

induced by long-term (up to 5 weeks) treatment with escitalopram. Escitalopram has 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.

Escitalopram also does not bind to, or has low affinity for, various ion channels including Na

, Cl

, and Ca

channels. Antagonism of muscarinic, histaminergic, and adrenergic receptors has been

hypothesized to be associated with various anticholinergic, sedative, and cardiovascular side effects of

other psychotropic drugs.

12.3 Pharmacokinetics

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 to 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 to 2.5 times the plasma concentrations observed after a

single dose. The tablet and the oral solution dosage forms of escitalopram are bioequivalent.

Absorption and Distribution

Following a single oral dose (20 mg tablet) 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. In vitro studies show that escitalopram is at least 7 and 27

1 to 7

1 to 5

1 to 3

1 to 5

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

, Cl , and Ca

channels.

In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary

isozymes involved in the Ndemethylation of escitalopram.

Population Subgroups

Adolescents - In a single dose study of 10 mg escitalopram, AUC of escitalopram decreased by 19%,

and C

increased by 26% in healthy adolescent subjects (12 to 17 years of age) compared to adults.

Following multiple dosing of 40 mg/day citalopram, escitalopram elimination half-life, steady-state C

and AUC were similar in patients with MDD (12 to 17 years of age) compared to adult patients. No

adjustment of dosage is needed in adolescent patients.

Elderly - Escitalopram pharmacokinetics in subjects ≥ 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 [ see Dosage and Administration ( 2.3) ].

Gender - Based on data from single- and multiple-dose studies measuring escitalopram in elderly,

young adults, and adolescents, no dosage adjustment on the basis of gender is needed.

Reduced hepatic function - Citalopram oral clearance was reduced by 37% and half-life was doubled in

patients with reduced hepatic function compared to normal subjects. 10 mg is the recommended dose of

escitalopram for most hepatically impaired patients [ see Dosage and Administration ( 2.3) ].

Reduced renal function - In patients with mild to moderate renal function impairment, oral clearance of

citalopram was reduced by 17% compared to normal subjects. No adjustment of dosage for such patients

is recommended. No information is available about the pharmacokinetics of escitalopram in patients with

severely reduced renal function (creatinine clearance < 20 mL/min).

Drug-Drug Interactions

In vitro enzyme inhibition data did not reveal an inhibitory effect of escitalopram on CYP3A4, -1A2, -

2C9, -2C19, and -2E1. Based on in vitro data, escitalopram would be expected to have little inhibitory

effect on in vivo metabolism mediated by these cytochromes. While in vivo data to address this question

are limited, results from drug interaction studies suggest that escitalopram, at a dose of 20 mg, has no

3A4 inhibitory effect and a modest 2D6 inhibitory effect. See Drug Interactions ( 7.18) for more

detailed information on available drug interaction data.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Racemic citalopram was administered in the diet to NMRI/BOM strain mice and COBS WI strain rats for

18 and 24 months, respectively. There was no evidence for carcinogenicity of racemic citalopram in

mice receiving up to 240 mg/kg/day. There was an increased incidence of small intestine carcinoma in

rats receiving 8 or 24 mg/kg/day racemic citalopram. A no-effect dose for this finding was not

established. The relevance of these findings to humans is unknown.

Mutagenesis

1 to 7

1 to 5

1 to 3

1 to 5

Racemic citalopram was mutagenic in the in vitro bacterial reverse mutation assay (Ames test) in 2 of 5

bacterial strains (Salmonella TA98 and TA1537) in the absence of metabolic activation. It was

clastogenic in the in vitro Chinese hamster lung cell assay for chromosomal aberrations in the presence

and absence of metabolic activation. Racemic citalopram was not mutagenic in the in vitro mammalian

forward gene mutation assay (HPRT) in mouse lymphoma cells or in a coupled in vitro/in vivo

unscheduled DNA synthesis (UDS) assay in rat liver. It was not clastogenic in the in vitro chromosomal

aberration assay in human lymphocytes or in two in vivo mouse micronucleus assays.

Impairment of Fertility

When racemic citalopram was administered orally to 16 male and 24 female rats prior to and throughout

mating and gestation at doses of 32, 48, and 72 mg/kg/day, mating was decreased at all doses, and

fertility was decreased at doses ≥ 32 mg/kg/day. Gestation duration was increased at 48 mg/kg/day.

13.2 Animal Toxicology and/or Pharmacology

Retinal Changes in Rats

Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year

carcinogenicity study with racemic citalopram. There was an increase in both incidence and severity of

retinal pathology in both male and female rats receiving 80 mg/kg/day. Similar findings were not present

in rats receiving 24 mg/kg/day of racemic citalopram for two years, in mice receiving up to 240

mg/kg/day of racemic citalopram for 18 months, or in dogs receiving up to 20 mg/kg/day of racemic

citalopram for one year.

Additional studies to investigate the mechanism for this pathology have not been performed, and the

potential significance of this effect in humans has not been established.

Cardiovascular Changes in Dogs

In a one-year toxicology study, 5 of 10 beagle dogs receiving oral racemic citalopram doses of 8

mg/kg/day died suddenly between weeks 17 and 31 following initiation of treatment. Sudden deaths were

not observed in rats at doses of racemic citalopram up to 120 mg/kg/day, which produced plasma levels

of citalopram and its metabolites demethylcitalopram and didemethylcitalopram (DDCT) similar to those

observed in dogs at 8 mg/kg/day. A subsequent intravenous dosing study demonstrated that in beagle

dogs, racemic DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs.

14 CLINICAL STUDIES

14.1 Major Depressive Disorder

Adolescents

The efficacy of escitalopram as an acute treatment for major depressive disorder in adolescent patients

was established in an 8-week, flexible-dose, placebo-controlled study that compared escitalopram 10 to

20 mg/day to placebo in outpatients 12 to 17 years of age inclusive who met DSM-IV criteria for major

depressive disorder. The primary outcome was change from baseline to endpoint in the Children's

Depression Rating Scale - Revised (CDRS-R). In this study, escitalopram showed statistically

significant greater mean improvement compared to placebo on the CDRS-R.

The efficacy of escitalopram in the acute treatment of major depressive disorder in adolescents was

established, in part, on the basis of extrapolation from the 8-week, flexible-dose, placebo-controlled

study with racemic citalopram 20 to 40 mg/day. In this outpatient study in children and adolescents 7 to

17 years of age who met DSM-IV criteria for major depressive disorder, citalopram treatment showed

statistically significant greater mean improvement from baseline, compared to placebo, on the CDRS-R;

the positive results for this trial largely came from the adolescent subgroup.

Two additional flexible-dose, placebo-controlled MDD studies (one escitalopram study in patients ages

7 to 17 and one citalopram study in adolescents) did not demonstrate efficacy.

Although maintenance efficacy in adolescent patients has not been systematically evaluated, maintenance

efficacy can be extrapolated from adult data along with comparisons of escitalopram pharmacokinetic

parameters in adults and adolescent patients.

Adults

The efficacy of escitalopram as a treatment for major depressive disorder was established in three, 8-

week, placebo-controlled studies conducted in outpatients between 18 and 65 years of age who met

DSM-IV criteria for major depressive disorder. The primary outcome in all three studies was change

from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS).

A fixed-dose study compared 10 mg/day escitalopram and 20 mg/day escitalopram to placebo and 40

mg/day citalopram. The 10 mg/day and 20 mg/day escitalopram treatment groups showed statistically

significant greater mean improvement compared to placebo on the MADRS. The 10 mg and 20 mg

escitalopram groups were similar on this outcome measure.

In a second fixed-dose study of 10 mg/day escitalopram and placebo, the 10 mg/day escitalopram

treatment group showed statistically significant greater mean improvement compared to placebo on the

MADRS.

In a flexible-dose study, comparing escitalopram, titrated between 10 and 20 mg/day, to placebo and

citalopram, titrated between 20 and 40 mg/day, the escitalopram 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 escitalopram 10 or 20 mg/day, were

randomized to continuation of escitalopram 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 escitalopram experienced a statistically significant longer time to relapse compared to those

receiving placebo.

14.2 Generalized Anxiety Disorder

The efficacy of escitalopram in the acute treatment of Generalized Anxiety Disorder (GAD) was

demonstrated in three, 8-week, multicenter, flexible-dose, placebo-controlled studies that compared

escitalopram 10 to 20 mg/day to placebo in adult outpatients between 18 and 80 years of age who met

DSM-IV criteria for GAD. In all three studies, escitalopram 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

escitalopram has differential effects in these groups. There was no difference in response to

escitalopram between men and women.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Tablets

Escitalopram tablets, USP 5 mg are white to off-white, round, biconvex, film coated tablets debossed

with '135' on one side and '5' on other side.

Bottles of 30 NDC 71205-313-30

Bottles of 60 NDC 71205-313-60

Bottles of 90 NDC 71205-313-90

Storage and Handling

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

Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide

17.1 Information for Patients

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

escitalopram tablets.

General Information about Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers

about the benefits and risks associated with treatment with escitalopram and should counsel them in its

appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other

Serious Mental Illness, and Suicidal Thoughts or Actions" is available for escitalopram tablets. The

prescriber or health professional should instruct patients, their families, and their caregivers to read the

Medication Guide and should assist them in understanding its contents. Patients should be given the

opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they

may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur

while taking escitalopram tablets.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of

anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia

(psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of

depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is

adjusted up or down. Families and caregivers of patients should be advised to look for the emergence

of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be

reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset,

or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an

increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and

possibly changes in the medication [ see Warnings and Precautions ( 5.1) ].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of

escitalopram with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl,

lithium, tramadol, tryptophan, buspirone, amphetamines and St. John's Wort, and with drugs that impair

metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and

also others, such as linezolid) [ see Warnings and Precautions ( 5.2) ].

Abnormal Bleeding

Patients should be cautioned about the concomitant use of escitalopram and NSAIDs, aspirin, warfarin,

or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with

serotonin reuptake and these agents has been associated with an increased risk of bleeding [ see

Warnings and Precautions ( 5.7) ].

Angle Closure Glaucoma

Patients should be advised that taking escitalopram tablets 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) ].

Concomitant Medications

Since escitalopram is the active isomer of racemic citalopram (Celexa), the two agents should not be

coadministered. Patients should be advised to inform their physician if they are taking, or plan to take,

any prescription or over-the-counter drugs, as there is a potential for interactions.

Continuing the Therapy Prescribed

While patients may notice improvement with escitalopram tablets therapy in 1 to 4 weeks, they should be

advised to continue therapy as directed.

Interference with Psychomotor Performance

Because psychoactive drugs may impair judgment, thinking, or motor skills, patients should be cautioned

about operating hazardous machinery, including automobiles, until they are reasonably certain that

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

Alcohol

Patients should be told that, although escitalopram has not been shown in experiments with normal

subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of

escitalopram and alcohol in depressed patients is not advised.

Pregnancy and Breast Feeding

Patients should be advised to notify their physician if they

o become pregnant or intend to become pregnant during therapy.

o are breastfeeding an infant.

Need for Comprehensive Treatment Program

Escitalopram tablets are indicated as an integral part of a total treatment program for MDD that may

include other measures (psychological, educational, social) for patients with this syndrome. Drug

treatment may not be indicated for all adolescents with this syndrome. Safety and effectiveness of

escitalopram in MDD has not been established in pediatric patients less than 12 years of age.

Antidepressants are not intended for use in the adolescent who exhibits symptoms secondary to

environmental factors and/or other primary psychiatric disorders. Appropriate educational placement is

essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient,

the decision to prescribe antidepressant medication will depend upon the physician's assessment of the

chronicity and severity of the patient's symptoms.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8075448 Revised June 2019

17.2 FDA-Approved Medication Guide

Medication Guide

Escitalopram (EE sye TAL o pram) Tablets, USP

Read the Medication Guide that comes with escitalopram tablets before you start taking it and each time

you get a refill. There may be new information. This Medication Guide does not take the place of

talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare

provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about escitalopram tablets?

Escitalopram tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Keep all follow-up visits with your healthcare provider and call between visits if you are worried

about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or

call 911 if an emergency, especially if they are new, worse, or worry you:

Call your healthcare provider right away if you have any of the following symptoms, or

call 911 if an emergency. Escitalopram tablets may be associated with these serious side

effects :

2. Serotonin Syndrome. This condition can be life-threatening and may include:

Escitalopram tablets and other antidepressant medicines may increase suicidal

thoughts or actions in some children, teenagers, or young adults within the first few months

of treatment or when the dose is changed.

Depression or other serious mental illnesses are the most important causes of suicidal thoughts

or actions.

Watch for these changes and call your healthcare provider right away if you notice:

New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

Pay particular attention to such changes when escitalopram tablets are started or when the dose is

changed.

attempts to commit suicide

acting on dangerous impulses

acting aggressive or violent

thoughts about suicide or dying

new or worse depression

new or worse anxiety or panic attacks

feeling agitated, restless, angry or irritable

trouble sleeping

an increase in activity or talking more than what is normal for you

other unusual changes in behavior or mood

agitation, hallucinations, coma or other changes in mental status

coordination problems or muscle twitching (overactive reflexes)

3. Severe allergic reactions:

4. Abnormal bleeding: Escitalopram tablets and other antidepressant medicines may increase your risk

of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin

, Jantoven

), a

non-steroidal antiinflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. Manic episodes:

7. Changes in appetite or weight. Children and adolescents should have height and weight

monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms

may include:

9. Visual problems

Only some people are at risk for these problems. You may want to undergo an eye examination to see if

you are at risk and receive preventative treatment if you are.

Do not stop escitalopram tablets without first talking to your healthcare provider. Stopping

escitalopram tablets too quickly may cause serious symptoms including:

racing heartbeat, high or low blood pressure

sweating or fever

nausea, vomiting, or diarrhea

muscle rigidity

trouble breathing

swelling of the face, tongue, eyes or mouth

rash, itchy welts (hives) or blisters, alone or with fever or joint pain

greatly increased energy

severe trouble sleeping

racing thoughts

reckless behavior

unusually grand ideas

excessive happiness or irritability

talking more or faster than usual

headache

weakness or feeling unsteady

confusion, problems concentrating or thinking or memory problems

eye pain

changes in vision

swelling or redness in or around the eye

anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

headache, sweating, nausea, dizziness

electric shock-like sensations, shaking, confusion

What are escitalopram tablets?

Escitalopram tablets are a prescription medicine used to treat depression. It is important to talk with your

healthcare provider about the risks of treating depression and also the risks of not treating it. You

should discuss all treatment choices with your healthcare provider. Escitalopram tablets are also used

to treat:

Talk to your healthcare provider if you do not think that your condition is getting better with

escitalopram tablets treatment.

Who should not take escitalopram tablets?

Do not take escitalopram tablets if you:

People who take escitalopram tablets close in time to an MAOI may have serious or

even life-threatening side effects. Get medical help right away if you have any of these

s ymptoms :

○ high fever

○ uncontrolled muscle spasms

○ stiff muscles

○ rapid changes in heart rate or blood pressure

○ confusion

○ loss of consciousness (pass out)

What should I tell my healthcare provider before taking escitalopram tablets? Ask if you

are not sure.

Before starting escitalopram tablets, tell your healthcare provider if you:

Major Depressive Disorder (MDD)

Generalized Anxiety Disorder (GAD)

are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets. See the

end of this Medication Guide for a complete list of ingredients in escitalopram tablets.

Take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or a pharmacist if you

are not sure if you take an MAOI, including linezolid.

Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by

your physician

Do not start escitalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed

to do so by your physician.

Do not take escitalopram tablets with Orap

(pimozide) because taking these two drugs together

can cause serious heart problems.

Are taking certain drugs such as:

Triptans used to treat migraine headache

Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics,

lithium, SSRIs, SNRIs, amphetamines or antipsychotics

tramadol

Over-the-counter supplements such as tryptophan or St. John's Wort

have liver problems

Tell your healthcare provider about all the medicines that you take, including prescription and

non-prescription medicines, vitamins, and herbal supplements. Escitalopram tablets and some medicines

may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take escitalopram tablets with your

other medicines. Do not start or stop any medicine while taking escitalopram tablets without talking to

your healthcare provider first.

If you take escitalopram tablets, you should not take any other medicines that contain escitalopram or

citalopram including: Celexa.

How should I take escitalopram tablets?

What should I avoid while taking escitalopram tablets?

Escitalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or

react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you

know how escitalopram tablets affect you. Do not drink alcohol while using escitalopram tablets.

What are the possible side effects of escitalopram tablets?

Escitalopram tablets may cause serious side effects, including all of those described in the

section entitled "What is the most important information I should know about escitalopram tablets?"

Common possible side effects in people who take escitalopram tablets include :

have kidney problems

have heart problems

have or had seizures or convulsions

have bipolar disorder or mania

have low sodium levels in your blood

have a history of a stroke

have high blood pressure

have or had bleeding problems

are pregnant or plan to become pregnant. It is not known if escitalopram tablets will harm your

unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression

during pregnancy

are breast-feeding or plan to breast-feed. Some escitalopram may pass into your breast milk. Talk

to your healthcare provider about the best way to feed your baby while taking escitalopram

tablets.

Take escitalopram tablets exactly as prescribed. Your healthcare provider may need to change

the dose of escitalopram tablets until it is the right dose for you.

Escitalopram tablets may be taken with or without food.

If you miss a dose of escitalopram tablets, take the missed dose as soon as you remember. If it is

almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do

not take two doses of escitalopram tablets at the same time.

If you take too much escitalopram tablets, call your healthcare provider or poison control center

right away, or get emergency treatment.

Nausea

Sleepiness

Weakness

Other side effects in children and adolescents include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of escitalopram tablets. For more information, ask your

healthcare provider or pharmacist.

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 escitalopram tablets?

Keep escitalopram tablets and all medicines out of the reach of children.

General information about escitalopram tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not

use escitalopram tablets for a condition for which it was not prescribed. Do not give escitalopram

tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about escitalopram tablets. If you

would like more information, talk with your healthcare provider. You may ask your healthcare provider

or pharmacist for information about escitalopram tablets that is written for healthcare professionals.

For more information about escitalopram tablets call 1-800-912-9561.

What are the ingredients in escitalopram tablets?

Active ingredient: escitalopram oxalate, USP

Inactive ingredients:

Dizziness

Feeling anxious

Trouble sleeping

Sexual problems

Sweating

Shaking

Not feeling hungry

Dry mouth

Constipation

Infection

Yawning

increased thirst

abnormal increase in muscle movement or agitation

nose bleed

difficult urination

heavy menstrual periods

possible slowed growth rate and weight change. Your child's height and weight should be

monitored during treatment with escitalopram tablets.

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

to 86°F) [see USP Controlled Room Temperature].

Keep escitalopram tablets bottle closed tightly.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., INDIA.

Manufactured For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

Repackaged by:

PROFICIENT RX LP, Thousand Oaks, CA 91320.

8075449 Revised June 2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Escitalopram Tablets USP 5 mg

ESCITALOPRAM OXALATE

escitalopram oxalate tablet

Tablets : cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium,

magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene

glycol 400 and titanium dioxide.

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:7120 5-313(NDC:136 6 8 -135)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ESCITALO PRAM O XALATE (UNII: 5U8 5DBW7LO) (ESCITALOPRAM - UNII:4O4S742ANY)

ESCITALOPRAM

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

TALC (UNII: 7SEV7J4R1U)

HYPRO MELLO SE 2 9 10 ( 6 MPA.S) (UNII: 0 WZ8 WG20 P6 )

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (white)

S core

no sco re

S hap e

ROUND (ro und)

S iz e

6 mm

Flavor

Imprint Code

135;5

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7120 5-313-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

2

NDC:7120 5-313-6 0

6 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

3

NDC:7120 5-313-9 0

9 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 9 0 9 39

0 9 /11/20 12

Labeler -

Proficient Rx LP (079196022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Proficient Rx LP

Pro ficient Rx LP

0 79 19 6 0 22

REPACK(7120 5-313) , RELABEL(7120 5-313)

Revised: 3/2020

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