Uses

Major Depressive Disorder

Management of major depressive disorder.

Efficacy in hospital settings not established.

Generalized Anxiety Disorder

Management of generalized anxiety disorder.

Dosage and Administration

General

• Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, and vice versa.
• 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 of therapy. To avoid withdrawal reactions, taper dosage gradually. (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)
• Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Fetal/Neonatal Morbidity and Mortality 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.

Adults

Major Depressive Disorder

Oral

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

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

Generalized Anxiety Disorder

Oral

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

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

Special Populations

Dosage in Hepatic Impairment

10 mg daily.

Dosage in 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 daily.

Cautions

Contraindications

• Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor. (See MAO Inhibitors under Warnings and see Specific Drugs under Interactions.)
• Concurrent pimozide therapy. (See Specific Drugs under Interactions.)
• Known hypersensitivity to escitalopram, citalopram, or any ingredient in the formulation.

Warnings/Precautions

Warnings

MAO Inhibitors

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS). (See Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”] or drugs that impair serotonin metabolism (e.g., MAO inhibitors). Symptoms 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). (See Specific Drugs under Interactions.)

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 Withdrawal of Therapy under Cautions.)

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.

Bipolar Disorder

May unmask bipolar disorder. (See Activation of Mania or Hypomania under Cautions.) Escitalopram is not approved for use in treating bipolar depression.

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.

Fetal/Neonatal Morbidity and Mortality

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.

Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial morbidity and mortality.

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.

Sensitivity Reactions

Hypersensitivity Reactions

Possible anaphylaxis, allergic reactions, and angioedema.

General Precautions

Withdrawal of Therapy

Possibly severe withdrawal reactions (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania); avoid abrupt discontinuance of therapy. Taper dosage gradually (e.g., over a period of several weeks).

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding; use with caution.

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk. (See Interactions.)

SIADH or Hyponatremia

Possible SIADH secretion or hyponatremia requiring medical intervention and/or escitalopram discontinuance.

Activation of Mania or Hypomania

Possible activation of mania and hypomania in major depressive disorder; use with caution in patients with a history of mania. (See Bipolar Disorder under Cautions.)

Seizures

Risk of seizures not systematically evaluated; use with caution in patients with a history of seizures.

Cognitive/Physical Impairment

Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery).

Concomitant Disease

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

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT not studied.

Specific Populations

Pregnancy

Category C. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.

Lactation

Distributed into milk; possible serious adverse reactions (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants. Discontinue nursing or the drug.

Pediatric Use

Safety and efficacy not established in children <18 years of age. The manufacturer states that escitalopram was not demonstrated to be effective in a placebo-controlled trial in children and adolescents with major depressive disorder.

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) 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 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.

Titrate dosage carefully. (See Geriatric Patients under Dosage and Administration.)

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.) Use with caution.

Renal Impairment

Use with caution in patients with severe renal impairment (Cl_cr <20 mL/minute). (See Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

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