Brand name: Lexapro
Drug class: Selective Serotonin-reuptake Inhibitors
- Selective Serotonin-reuptake Inhibitors
- Serotonin-reuptake Inhibitors
- SSRIs
VA class: CN609
Chemical name: 1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-S-(+)-5-isobenzofurancarbonitrile oxalate
Molecular formula: C₂₀H₂₁FN₂O•C₂H₂O₄
CAS number: 219861-08-2

Medically reviewed by Drugs.com on Jan 25, 2024. Written by ASHP.

Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI) and S-enantiomer of citalopram.

Uses for Escitalopram

Major Depressive Disorder

Acute and maintenance treatment of major depressive disorder.

APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, TCAs, MAO inhibitors, and other antidepressants (e.g., bupropion, mirtazapine, trazodone). Choose antidepressant based mainly on patient preference; nature of prior response to medication; safety, tolerability, and anticipated adverse effects; concurrent psychiatric and medical conditions; and specific properties of the medication (e.g., half-life, actions on CYP isoenzymes, other drug interactions). For most patients, an SSRI, SNRI, mirtazapine, or bupropion is considered optimal. Consult APA’s Practice Guidelines for the Treatment of Patients with Major Depressive Disorder for additional information.

Generalized Anxiety Disorder

Management of generalized anxiety disorder.

Escitalopram Dosage and Administration

General

• Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, and vice versa. (See Contraindications and also see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)

• Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)

• Sustained therapy may be required; monitor periodically for need for continued therapy.

• Avoid abrupt discontinuance. Taper dosage gradually and monitor for withdrawal symptoms. If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage, then resume more gradual dosage reductions. (See Withdrawal of Therapy under Cautions.)

Administration

Oral Administration

Administer orally once daily (morning or evening) without regard to meals.

Dosage

Available as escitalopram oxalate; dosage is expressed in terms of escitalopram.

Escitalopram dosages of 10 mg daily appear to be comparable to racemic citalopram dosages of 40 mg daily.

Pediatric Patients

Major Depressive Disorder

Oral

Adolescents 12–17 years of age: Initially, 10 mg once daily. May be increased to 20 mg once daily after ≥3 weeks; efficacy established at dosages of 10–20 mg once daily in a flexible-dose study.

Optimum duration not established; may require several months of therapy or longer.

Adults

Major Depressive Disorder

Oral

Initially, 10 mg once daily. May be increased to 20 mg once daily after ≥1 week; however, no additional therapeutic benefit with 20 mg once daily compared with 10 mg once daily.

Optimum duration not established; may require several months of therapy or longer.

Generalized Anxiety Disorder

Oral

Initially, 10 mg once daily. Dosage may be increased to 20 mg once daily after ≥1 week.

Not studied >8 weeks of therapy; periodically reevaluate need for therapy.

Special Populations

Hepatic Impairment

10 mg once daily.

Renal Impairment

No dosage adjustment required in patients with mild to moderate renal impairment; not studied in patients with severe renal impairment (Cl_cr <20 mL/minute).

Geriatric Patients

10 mg once daily.

Cautions for Escitalopram

Contraindications

• Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor. (See Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions and also see Interactions.)

• Concurrent pimozide therapy. (See Interactions.)

• Known hypersensitivity to escitalopram, citalopram, or any ingredient in the formulation.

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs. However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

Appropriately monitor and closely observe patients receiving escitalopram for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments. (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality. Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms. If decision is made to discontinue therapy, taper escitalopram dosage as rapidly as is feasible but consider risks of abrupt discontinuance. (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.

Other Warnings and Precautions

Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions reported with SSRIs, including escitalopram, and SNRIs alone, but particularly with concurrent administration of other serotonergic drugs (e.g., 5-HT₁ receptor agonists [triptans]), drugs that impair serotonin metabolism (e.g., MAO inhibitors), or antipsychotics or other dopamine antagonists. (See Contraindications under Cautions and also see Interactions.)

Symptoms of serotonin syndrome may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).

Severe serotonin syndrome may resemble NMS, which is characterized by hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation in vital signs, and mental status changes.

Monitor patients receiving escitalopram for the development of serotonin syndrome or NMS-like signs and symptoms. If signs and symptoms occur, immediately discontinue treatment with escitalopram and any concurrently administered serotonergic or antidopaminergic agents, including antipsychotic agents, and initiate supportive and symptomatic treatment.

Withdrawal of Therapy

Withdrawal effects (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances [e.g., paresthesias, such as electric shock sensations], anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, seizures) reported following discontinuance of serotonergic antidepressants, particularly when discontinuance was abrupt. Events generally self-limiting, but serious cases reported.

Taper dosage gradually; monitor patients for withdrawal symptoms when discontinuing therapy. If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage then resume more gradual dosage reductions.

Seizures

Escitalopram not systematically evaluated in patients with a seizure disorder; use with caution in patients with a history of seizure disorder.

Activation of Mania/Hypomania

Possible activation of mania and hypomania; use with caution in patients with a history of mania.

Hyponatremia or SIADH

Treatment with SSRIs, including escitalopram, and SNRIs may cause hyponatremia; in many cases, SIADH is apparent cause. Increased risk in patients who are volume-depleted, elderly, or taking diuretics. Consider drug discontinuance and initiate appropriate medical intervention in patients with symptomatic hyponatremia.

Abnormal Bleeding

Possible increased risk of bleeding with SSRIs, including escitalopram, and SNRIs; events ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Concomitant use of aspirin, NSAIAs, warfarin, or other anticoagulants may increase risk. (See Drugs Affecting Hemostasis under Interactions.)

Interference with Cognitive and Motor Performance

Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery). Escitalopram did not impair intellectual function or psychomotor performance in healthy individuals. However, any psychoactive drug may impair judgment, thinking, or motor skills. (See Advice to Patients.)

Concomitant Illnesses

Limited experience; use with caution in patients with altered metabolism or hemodynamic responses.

MAO Inhibitors Interaction

Concomitant use of SSRIs and MAO inhibitors associated with serious, sometimes fatal, reactions, including hyperthermia, rigidity, myoclonus, autonomic instability, and mental status change; these reactions have resembled serotonin syndrome or neuroleptic malignant syndrome (NMS). (See Contraindications and also see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT not studied.

Specific Populations

Pregnancy

Category C.

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care reported in neonates exposed to escitalopram, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.

Conflicting findings from available studies evaluating possible risk of persistent pulmonary hypertension of the newborn (PPHN) following in utero exposure to SSRIs; currently unclear whether SSRI use during pregnancy can cause PPHN.

Consult joint APA and ACOG guidelines (at [Web]) for additional information on management of depression in women prior to conception and during pregnancy, including treatment algorithms.

Lactation

Distributed into milk; possible serious adverse reactions (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants. Use with caution and observe nursing infants for possible adverse reactions.

Pediatric Use

Safety and efficacy not established in children <12 years of age with major depressive disorder. Safety and effectiveness established in adolescents 12–17 years of age for the acute treatment of major depressive disorder. Efficacy of escitalopram as maintenance therapy in adolescent patients with major depressive disorder not systematically evaluated; however, can extrapolate such efficacy from adult data along with comparisons of pharmacokinetic parameters in adults and adolescent patients.

Safety and efficacy not established in children <18 years of age with generalized anxiety disorder.

Decreased appetite and weight loss observed with the use of SSRIs; monitor weight and growth regularly in children and adolescents treated with escitalopram.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment compared with placebo in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others). However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation. No suicides occurred in these pediatric trials.

Carefully consider these findings when assessing potential benefits and risks of escitalopram in a child or adolescent for any clinical use. (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.

In geriatric individuals, AUC and elimination half-life of escitalopram are increased by approximately 50%. (See Geriatric Patients under Dosage and Administration.)

Clinically important hyponatremia reported in geriatric patients, who may be at increased risk for this adverse effect. Some clinicians recommend periodic monitoring (especially during the first several months) of serum sodium concentrations in geriatric patients receiving SSRIs. (See Hyponatremia or SIADH under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo. (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Systemic exposure to escitalopram may be increased. (See Elimination: Special Populations, under Pharmacokinetics.) (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Use with caution in patients with severe renal impairment (Cl_cr <20 mL/minute). (See Renal Impairment under Dosage and Administration and also see Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Insomnia, nausea, increased sweating, sexual dysfunction (ejaculation disorder [primarily ejaculatory delay], decreased libido, anorgasmia), fatigue, somnolence.

Drug Interactions

Extensively metabolized in the liver, principally by CYP2C19 and 3A4. Does not inhibit CYP1A2, 2C9, 2C19, 2E1, or 3A4 in vitro and exhibits only modest inhibition against CYP2D6.

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of CYP2C19 and 3A4: clinically important pharmacokinetic interaction unlikely since escitalopram is metabolized by multiple enzyme systems.

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP2D6: potential pharmacokinetic (increased peak plasma concentrations and AUC of the substrate) interactions. Use with caution.

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis. Use with caution. (See Abnormal Bleeding under Cautions.)

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions) with serotonergic agents. Avoid such use, or use with caution. (See Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.) If serotonin syndrome or NMS occurs, immediately discontinue escitalopram and any concurrently administered serotonergic or antidopaminergic agents and initiate supportive and symptomatic treatment.

Specific Drugs

Escitalopram Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration, with peak plasma concentration usually attained within 5 hours.

Commercially available tablets and oral solution are bioequivalent.

Onset

Antidepressant effect usually occurs within 1–4 weeks.

Food

Food does not affect absorption.

Special Populations

In geriatric patients, AUC is increased approximately 50%.

Distribution

Extent

Crosses the placenta.

Distributed into breast milk.

Plasma Protein Binding

Approximately 56%.

Elimination

Metabolism

Extensively metabolized in the liver to less pharmacologically active metabolites by multiple enzyme systems, including CYP3A4 and CYP2C19.

Elimination Route

Eliminated principally in urine.

Half-life

27–32 hours.

Special Populations

In geriatric individuals, half-life is increased by approximately 50%.

Hepatic impairment decreases racemic citalopram oral clearance by 37% and doubles its half-life.

Mild to moderate renal impairment decreases racemic citalopram oral clearance by 17%. Pharmacokinetics not studied in patients with severe renal impairment (Cl_cr <20 mL/minute).

Stability

Storage

Oral

Solution and Tablets

25°C; excursions permitted to 15–30°C.

Actions

• S-enantiomer of citalopram, an SSRI that occurs as a 50:50 racemic mixture of the R- and S-enantiomers.

• At least 100-fold more potent as an inhibitor of serotonin (5-hydroxytryptamine [5-HT]) reuptake at presynaptic membranes and 5-HT neuronal firing rate than R-enantiomer and is twice as potent as racemic mixture.

• Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).

• Highly selective; minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake and little or no affinity for α- or β-adrenergic, dopamine D_1–5, histamine H_1–3, GABA-benzodiazepine, muscarinic M_1–5, or 5-HT_1–7 receptors or various ion channels (e.g., calcium, chloride, potassium, sodium channels).

Advice to Patients

• Importance of providing copy of written patient information (medication guide) each time escitalopram is dispensed. Importance of advising patients to read the patient information before taking escitalopram and each time the prescription is refilled.

• Risk of suicidality; importance of patients, families, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment. (See Worsening of Depression and Suicidality Risk under Cautions.)

• Importance of informing patients of potential risk of serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions, particularly with concurrent use of escitalopram and 5-HT₁ receptor agonists (also called triptans), tramadol, tryptophan, other serotonergic agents, or antipsychotic agents. Importance of immediately contacting clinician if signs and symptoms of these syndromes develop (e.g., restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, muscle stiffness, labile BP, diarrhea, coma, nausea, vomiting, confusion).

• Risk of psychomotor impairment; importance of exercising caution while operating hazardous machinery, including automobile driving, until patients gain experience with the drug’s effects.

• Importance of patients being aware that withdrawal effects may occur when stopping escitalopram, especially with abrupt discontinuance of the drug.

• Risks associated with concomitant use of escitalopram with alcohol or racemic citalopram.

• Importance of continuing escitalopram therapy even if a response is not evident within 1–4 weeks, unless directed otherwise.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs or herbal supplements, as well as any concomitant illnesses (e.g., bipolar disorder) or personal or family history of suicidality or bipolar disorder.

• Importance of advising patients about the risk of bleeding or bruising associated with concomitant use of escitalopram with aspirin or other NSAIAs, warfarin, or other drugs that affect coagulation.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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