FDA

Escitalopram Oxalate

Approved 12 Jun 2013OralSolution

The FDA lists this product in 60 strengths and forms.

Indications

Escitalopram is indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s Lexapro (escitalopram) tablets and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )

Contraindications

Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. The use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration (2.7) and Warnings and Precautions (5.2) ]. Starting escitalopram 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) ]. taking pimozide [ see Drug Interactions (7) ] with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in escitalopram.

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 ) Concomitant use of pimozide ( 4 ) Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients ( 4 )

Warnings and precautions

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue escitalopram and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3 ) Seizures: Use with caution in patients with a history of seizure ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6 ) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other drugs that affect coagulation may increase risk ( 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 ) Sexual Dysfunction: Escitalopram may cause symptoms of sexual dysfunction ( 5.11 )

At a glance

Brand name: Escitalopram Oxalate
Route: Oral
Dosage form: Solution
Applicant: Chartwell Molecular
Status: Prescription
FDA approval: 12 Jun 2013
Application: ANDA090477-001

Indications

Contraindications

Warnings and precautions

Interactions

Table 6 presents clinically important drug interactions with escitalopram. TABLE 6 Clinically Important Drug Interactions with Escitalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including escitalopram, and MAOIs increases the risk of serotonin syndrome. Intervention: Escitalopram is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [ see Dosage and Administration (2.7) , Contraindications (4) , and Warnings and Precautions (5.2) ] Pimozide Clinical Impact: Concomitant use of racemic citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of racemic citalopram alone [ see Clinical Pharmacology (12.3) ].

Intervention: Escitalopram is contraindicated in patients taking pimozide [ see Contraindications (4) ]. Other Serotonergic Drugs Clinical Impact: Concomitant use of escitalopram and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John’s Wort) increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during escitalopram initiation and dosage increases.

If serotonin syndrome occurs, consider discontinuation of escitalopram and/or concomitant serotonergic drugs [ see Warnings and Precautions(5.2) ] Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) Clinical Impact: Concomitant use of escitalopram and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of escitalopram and antiplatelet agents and anticoagulants.

For patients taking warfarin, carefully monitor the internationalnormalized ratio [ see Warnings and Precautions (5.7) ]. Sumatriptan Clinical Impact: There have been postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of an SSRI and sumatriptan. Intervention: If concomitant treatment with sumatriptan and an SSRI is clinically warranted, appropriate observation of the patient is advised [ see Warnings and Precautions (5.2) ].

Carbamazepine Clinical Impact: Combined administration of racemic citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Intervention: Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of escitalopram should be considered if the two drugs are coadministered.

Drugs Metabolized by CYP2D6 Clinical Impact: Coadministration of escitalopram (20 mg/day for 21 days) with the tricyclic antidepressant desipramine (single dose of 50 mg), a substrate for CYP2D6, resulted in a 40% increase in C max and a 100% increase in AUC of desipramine. Intervention: The clinical significance of this finding is unknown. Exercise caution during coadministration of escitalopram and drugs metabolized by CYP2D6.

Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended ( 7 ) Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) ( 7 )

Adverse reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [ see Warnings and Precautions (5.1) ] Serotonin syndrome [ see Warnings and Precautions(5.2) ] Discontinuation syndrome [ see Warnings and Precautions(5.3) ] Seizures [ see Warnings and Precautions (5.4) ] Activation of mania or hypomania [ see Warnings and Precautions (5.5) ] Hyponatremia [ see Warnings and Precautions (5.6) ] Increased Risk of Bleeding [ see Warnings and Precautions (5.7) ] Interference with Cognitive and Motor Performance [ see Warnings and Precautions (5.8) ] Angle-closure glaucoma [ see Warnings and Precautions (5.9) ] Use in Patients with Concomitant Illness [ see Warnings and Precautions (5.10) ] Sexual Dysfunction [ see Warnings and Precautions (5.11) ] 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 Chartwell RX, LLC. at 1-845-232-1683, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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 Adults Adverse reactions 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 reaction 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 reactions during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing.

Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse reactions without first grouping similar types of reactions into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse reactions. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment emergent adverse event of the type listed.

An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Pediatric Patients Adverse reaction information for pediatric patients was collected in double-blind placebo-controlled studies in 576 pediatric patients 6 to 17 years of age, (286 escitalopram, 290 placebo) with major depressive disorder. The safety and effectiveness of escitalopram have not been established in pediatric patients less than 12 years of age with MDD or less than 7 years of age with GAD.

Adverse Reactions Associated with Discontinuation of Treatment Major Depressive Disorder Adults Among the 715 depressed patients who received 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 reactions in patients receiving 10 mg/day escitalopram was not significantly different from the rate of discontinuation for adverse reactions in patients receiving placebo.

The rate of discontinuation for adverse reactions in patients assigned to a fixed dose of 20 mg/day escitalopram was 10%, which was significantly different from the rate of discontinuation for adverse reactions in patients receiving 10 mg/day escitalopram (4%) and placebo (3%). Adverse reactions that were associated with the discontinuation of at least 1% of patients treated with escitalopram, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients).

Pediatric Patients Adverse reactions in pediatric patients 6 to 17 years of age were associated with discontinuation of 3.5% of 286 patients receiving escitalopram and 1% of 290 patients receiving placebo. The most common adverse reaction (incidence at least 1% for escitalopram and greater than placebo) associated with discontinuation was insomnia (1% escitalopram, 0% placebo). The safety and effectiveness of escitalopram have not been established in pediatric patients less than 12 years of age with MDD.

Generalized Anxiety Disorder Adults Among the 429 GAD patients who received 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 reactions 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 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 adverse reactions that occurred among 715 depressed patients who received escitalopram at doses ranging from 10 to 20 mg/day in placebo-controlled trials.

Reactions included are those occurring in 2% or more of patients treated with escitalopram and for which the incidence in patients treated with escitalopram was greater than the incidence in placebo-treated patients. TABLE 2 Adverse Reactions observed with a frequency of ≥ 2% and greater than placebo for Major Depressive Disorder (Adults) Adverse Reaction Escitalopram Placebo (N=715) % (N=592) % Autonomic Nervous System Disorders Dry Mouth 6% 5% Sweating Increased 5% 2% Central & Peripheral Nervous System Disorders Dizziness 5% 3% Gastrointestinal Disorders Nausea 15% 7% Diarrhea 8% 5% Constipation 3% 1% Indigestion 3% 1% Abdominal Pain 2% 1% General Influenza-like Symptoms 5% 4% Fatigue 5% 2% Psychiatric Disorders Insomnia 9% 4% Somnolence 6% 2% Appetite Decreased 3% 1% Libido Decreased 3% 1% Respiratory System Disorders Rhinitis 5% 4% Sinusitis 3% 2% Urogenital Ejaculation Disorder 1,2 9% <1% Impotence 2 3% <1% Anorgasmia 3 2% <1% 1 Primarily ejaculatory delay. 2 Denominator used was for males only (N=225 escitalopram; N=188 placebo). 3 Denominator used was for females only (N=490 escitalopram; N=404 placebo).

Pediatric Patients The overall profile of adverse reactions in pediatric patients 6 to 17 years in major depressive disorder was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading) were reported at an incidence of at least 2% for escitalopram and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion.

The safety and effectiveness of escitalopram have not been established in pediatric patients less than 12 years of age with MDD. Generalized Anxiety Disorder Adults The most commonly observed adverse reactions in escitalopram patients (incidence of approximately 5% or greater an

Our copy of this section ends here. The full text is in the official label at the FDA. Open Drugs@FDA

Escitalopram Oxalate

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Escitalopram Oxalate

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults

5.2Serotonin Syndrome

5.3Discontinuation Syndrome

5.4Seizures

5.5Activation of Mania or Hypomania

Interactions

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information