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LEXAPRO(escitalopram oxalate)tablet, film coated
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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use Lexapro® safely and effectively. See full prescribing information for Lexapro®
Lexapro® (escitalopram oxalate) Tablets
Lexapro® (escitalopram oxalate) Oral Solution
Initial U.S. Approval: 2002
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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. Lexapro is not approved for use in pediatric patients less than 12 years of age (5.1).
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INDICATIONS AND USAGE
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Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for:
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Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1)
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Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)
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DOSAGE AND ADMINISTRATION
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Lexapro should generally be administered once daily, morning or evening with or without food (2.1, 2.2).
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Indication
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Recommended Dose
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MDD (2.1)
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Adolescents (2.1)
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Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
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Adults (2.1)
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Initial: 10 mg once daily
Recommended: 10 mg once daily
Maximum: 20 mg once daily
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GAD (2.2)
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Adults (2.2)
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Initial: 10 mg once daily
Recommended: 10 mg once daily
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No additional benefits seen at 20 mg/day dose (2.1).
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10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment (2.3).
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No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment (2.3).
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Discontinuing Lexapro: A gradual dose reduction is recommended (2.4).
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DOSAGE FORMS AND STRENGTHS
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Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1)
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Oral solution: 1 mg per mL (3.2)
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CONTRAINDICATIONS
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Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping Lexapro before starting an MAOI (4.1, 5.10).
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Pimozide: Do not use concomitantly (4.2, 7.10).
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Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4.3).
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WARNINGS AND PRECAUTIONS
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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).
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Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Manage with immediate discontinuation and continuing monitoring (5.2).
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Discontinuation of Treatment with Lexapro: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible (5.3).
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Seizures: Prescribe with care in patients with a history of seizure (5.4).
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Activation of Mania/Hypomania: Use cautiously in patients with a history of mania (5.5).
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Hyponatremia: Can occur in association with SIADH (5.6).
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Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation (5.7).
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Interference with Cognitive and Motor Performance: Use caution when operating machinery (5.8).
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Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses (5.9).
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ADVERSE REACTIONS
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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 Forest Laboratories Inc. at 1-800-678-1605, or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
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DRUG INTERACTIONS
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Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended (7.1).
Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) (7.6).
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USE IN SPECIFIC POPULATIONS
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Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1).
Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3)
Pediatric Use: Safety and effectiveness of Lexapro has not been established in pediatric MDD patients less than 12 years of age (8.4).
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See 17 for PATIENT COUNSELING INFORMATION and Medication Guide |
Revised: 06/2011 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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WARNINGS: 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 Lexapro
2.5 Switching Patients To or From a Monoamine Oxidase Inhibitor
3 DOSAGE FORMS AND STRENGTHS
3.1 Tablets
3.2 Oral Solution
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 or Neuroleptic Malignant Syndrome (NMS)-like Reactions
5.3 Discontinuation of Treatment with Lexapro
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 Use in Patients with Concomitant Illness
5.10 Potential for Interaction with Monoamine Oxidase Inhibitors
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Serotonergic Drugs
7.2 Triptans
7.3 CNS Drugs
7.4 Alcohol
7.5 Monoamine Oxidase Inhibitors (MAOIs)
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
16.2 Oral Solution
17 PATIENT COUNSELING INFORMATION
17.1 Information for Patients
17.2 FDA-Approved Medication Guide
PACKAGE LABEL - LEXAPRO 5 MG TABLET
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FULL PRESCRIBING INFORMATION
WARNINGS: 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 Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients less than 12 years of age.[See Warnings and Precautions: Clinical Worsening and Suicide Risk (5.1), Patient Counseling Information: Information for Patients (17.1), and Used in Specific Populations: Pediatric Use (8.4)].
1 INDICATIONS AND USAGE
1.1 Major Depressive Disorder
Lexapro (escitalopram) is 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.
1.2 Generalized Anxiety Disorder
Lexapro is 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
Lexapro should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive Disorder
Initial Treatment
Adolescents
The recommended dose of Lexapro is 10 mg once daily. A flexible-dose trial of Lexapro (10 to 20 mg/day) demonstrated the effectiveness of Lexapro [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 Lexapro is 10 mg once daily. A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg [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 eva luation of continuing Lexapro 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking Lexapro during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-eva luate 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 Lexapro is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.
Maintenance Treatment
Generalized anxiety disorder is recognized as a chronic condition. The efficacy of Lexapro in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use Lexapro for extended periods should periodically re-eva luate 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. Lexapro should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Lexapro
Symptoms associated with discontinuation of Lexapro and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.5 Switching Patients To or From a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of Lexapro therapy. Similarly, at least 14 days should be allowed after stopping Lexapro before starting an MAOI [see Contraindications (4.1) and Warnings and Precautions (5.10)].
3 DOSAGE FORMS AND STRENGTHS
3.1 Tablets
Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with "FL" on one side and either "5", “10”, or “20” on the other side according to their respective strengths.
3.2 Oral Solution
Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base.
4 CONTRAINDICATIONS
4.1 Monoamine oxidase inhibitors (MAOIs)
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated [see Warnings and Precautions (5.10)].
4.2 Pimozide
Concomitant use in patients taking pimozide is contraindicated [see Drug Interactions (7.10)].
4.3 Hypersensitivity to escitalopram or citalopram
Lexapro is contraindicated in patients with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in Lexapro.
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 long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1.
TABLE 1
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Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated |
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Increases Compared to Placebo |
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<18 |
14 additional cases |
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18-24 |
5 additional cases |
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Decreases Compared to Placebo |
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25-64 |
1 fewer case |
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≥65 |
6 fewer cases |
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or a |
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