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Escitalopram

Medically reviewed on Sep 10, 2018

Pronunciation

See also: Ingrezza

(es sye TAL oh pram)

Index Terms

  • Escitalopram Oxalate
  • Lu-26-054
  • S-Citalopram

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Oral:

Lexapro: 5 mg/5 mL (240 mL [DSC]) [contains methylparaben, propylene glycol, propylparaben; peppermint flavor]

Generic: 5 mg/5 mL (240 mL)

Tablet, Oral:

Lexapro: 5 mg

Lexapro: 10 mg, 20 mg [scored]

Generic: 5 mg, 10 mg, 20 mg

Brand Names: U.S.

  • Lexapro

Pharmacologic Category

  • Antidepressant, Selective Serotonin Reuptake Inhibitor

Pharmacology

Escitalopram is the S-enantiomer of the racemic derivative citalopram, which selectively inhibits the reuptake of serotonin with little to no effect on norepinephrine or dopamine reuptake. It has no or very low affinity for 5-HT1-7, alpha- and beta-adrenergic, D1-5, H1-3, M1-5, and benzodiazepine receptors. Escitalopram does not bind to or has low affinity for Na+, K+, Cl-, and Ca++ ion channels.

Distribution

Vd: ~20 L/k (Søgaard 2005)

Metabolism

Hepatic via CYP2C19 and 3A4 to S-desmethylcitalopram (S-DCT); S-DCT is metabolized to S-didesmethylcitalopram (S-DDCT) via CYP2D6; in vitro data suggest metabolites do not contribute significantly to the antidepressant effects of escitalopram

Excretion

Urine (8% as unchanged drug; S-DCT 10%)

Clearance:

Hepatic impairment: Decreased by 37%

Mild to moderate renal impairment: Decreased by 17%

Severe renal impairment (CrCl <20 mL/minute): No information available

Onset of Action

Depression: The onset of action is within a week; however, individual response varies greatly and full response may not be seen until 8 to 12 weeks after initiation of treatment.

Time to Peak

Escitalopram: Adolescents: 2.9 hours; Adults: ~5 hours

Half-Life Elimination

Mean: Adolescents: 19 hours; Adults: ~27 to 32 hours (increased ~50% in the elderly and doubled in patients with hepatic impairment)

Protein Binding

~56% to plasma proteins

Special Populations: Elderly

AUC and half-life increased approximately 50%.

Use: Labeled Indications

Major depressive disorder (unipolar): Acute and maintenance treatment of unipolar major depressive disorder (MDD)

Generalized anxiety disorder: Acute treatment of generalized anxiety disorder (GAD)

Off Label Uses

Body dysmorphic disorder

Data from a limited number of patients studied suggest that escitalopram may be beneficial for the treatment of symptoms (including depression, insight, and psychosocial functioning) and prevention of relapse associated with body dysmorphic disorder [Phillips 2016].

Obsessive-compulsive disorder (OCD)

Data from a randomized, double-blind, placebo-controlled trial and a relapse prevention trial support the use of escitalopram in the treatment of OCD [Fineberg 2007], [Stein 2007].

Based on the American Psychiatric Association guidelines for the treatment of obsessive-compulsive disorder and the World Federation of Societies of Biological Psychiatry guidelines for the treatment of anxiety, obsessive-compulsive, and post-traumatic stress disorders, selective serotonin reuptake inhibitors (SSRIs) like escitalopram are first-line for the treatment of OCD [APA 2007], [WFSBP [Bandelow 2012]].

Panic disorder

Data from a double-blind, randomized, parallel-group, flexible-dose, placebo-controlled, multicenter study and an open label trial support the use of escitalopram in the treatment of panic disorder [Rampello 2006], [Stahl 2003].

Based on the American Psychiatric Association guidelines for the treatment of panic disorder and the World Federation of Societies of Biological Psychiatry guidelines for the treatment of anxiety, obsessive-compulsive, and post-traumatic stress disorders, escitalopram given for panic disorder is effective and recommended in the management of this condition.

Posttraumatic stress disorder

Data from a limited number of patients suggest that escitalopram may be beneficial for the treatment of posttraumatic stress disorder [Qi 2017], [Robert 2006].

Based on the American Psychiatric Association guidelines for the treatment of posttraumatic stress disorder, SSRIs are effective and recommended as first-line treatment for posttraumatic stress disorder. The guidelines provide no recommendations specific to escitalopram because at the time of publication no escitalopram studies were published; however, clinical consensus suggests SSRIs are equivalent in efficacy. Based on the World Federation of Societies of Biological Psychiatry (WFSBP) guidelines for the treatment of anxiety disorders, obsessive-compulsive disorder, and posttraumatic stress disorder in primary care, SSRIs like escitalopram are first line for the treatment of posttraumatic stress disorder.

Premenstrual dysphoric disorder

Data from a randomized, placebo controlled study support the use of escitalopram in the treatment of premenstrual dysphoric disorder during the luteal phase [Eriksson 2008]. Data from a small randomized, parallel-group, double-blind trial also suggest benefits for symptom based dosing [Freeman 2005].

Based on the International Society for Premenstrual Disorders auditable standards for diagnosis and management of premenstrual disorder, selective serotonin reuptake inhibitors are effective and recommended in the management of premenstrual dysphoric disorder [Ismaili 2016].

Vasomotor symptoms associated with menopause

Data from a randomized, double-blind placebo controlled trial supports the use of escitalopram in the treatment of vasomotor symptoms (hot flashes) in peri- or postmenopausal women [Carpenter 2012], [Freeman 2011].

Based on the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE) Position Statement on Menopause, the Endocrine Society (ES) Treatment of Symptoms of the Menopause guideline, and the North American Menopause Society (NAMS) Nonhormonal Management of Menopause-associated Vasomotor Symptoms guideline, SSRIs (including escitalopram) are effective and recommended alternatives for the management of vasomotor symptoms associated with menopause in patients with contraindications to hormonal therapy or who prefer not to use hormonal therapy. Based on the American Cancer Society (ACS)/American Society of Clinical Oncology (ASCO) Breast Cancer Survivorship Care guideline, SSRIs may be used to help mitigate vasomotor symptoms of premature menopause in women previously treated for breast cancer.

Contraindications

Hypersensitivity to escitalopram, citalopram, or any component of the formulation; use of MAO inhibitors intended to treat psychiatric disorders (concurrently or within 14 days of discontinuing either escitalopram or the MAO inhibitor); initiation of escitalopram in a patient receiving linezolid or intravenous methylene blue; concurrent use of pimozide

Canadian labeling: Additional contraindications (not in US labeling): Known QT-interval prolongation or congenital long QT syndrome

Dosing: Adult

Body dysmorphic disorder (off-label use): Oral: Initial: 10 mg once daily; gradually increase dose (3-week intervals were used in clinical trial) up to 30 mg once daily based on response and tolerability (Phillips 2016).

Generalized anxiety disorder: Oral: Initial: 10 mg once daily; dose may be increased after at least 1 week based on response and tolerability to a maximum of 20 mg once daily.

Major depressive disorder (unipolar): Oral: Initial: 10 mg once daily; dose may be increased in 10 mg increments after at least 1 week based on response and tolerability. Maximum dose: 20 mg once daily (according to the manufacturer’s labeling); however, doses up to 50 mg/day have been evaluated in an open-label trial. Median doses for remission were 30 mg/day; tolerability declined with doses >40 mg/day (Wade 2011).

Obsessive-compulsive disorder (off-label use): Oral: Initial: 10 mg once daily; dose may be increased in 10 mg increments at intervals no less than every 7 days up to 40 mg once daily (Fineberg 2007; Shim 2011). Higher doses up to ~60 mg/day have been evaluated in open label trials and may be considered in refractory patients; however, adverse effects may be increased (Rabinowitz 2008; Shim 2011).

Panic disorder (off-label use): Oral: Initial: 5 mg once daily for 7 days, then increase dose to 10 mg once daily. May further increase at intervals no less than 7 days up to 20 mg once daily based on response and tolerability; mean dose in clinical trials was ~10 mg once daily (Stahl 2003).

Posttraumatic stress disorder (off-label use): Oral: Initial: 10 mg once daily; may gradually increase dose (4-week intervals used in some trials) based on response and tolerability up to 40 mg once daily (Qi 2017; Robert 2006).

Premenstrual dysphoric disorder (off-label use): Note: Escitalopram continuous daily dosing regimens have not been evaluated in clinical trials.

Luteal phase dosing regimen: Oral: 10 mg once daily during the luteal phase of menstrual cycle (beginning therapy 14 days before anticipated onset of menstruation and continued to the onset of menses); may increase dose to 20 mg once daily after first menstrual cycle based on response and tolerability (Freeman 2005). May initiate each cycle with 5 mg and increase over several days if needed to improve tolerability (Eriksson 2008).

Symptom triggered dosing regimen: Oral: 10 mg once daily from the day of symptom onset until a few days after the start of menses; may increase dose to 20 mg once daily after first menstrual cycle based on response and tolerability (Freeman 2005).

Vasomotor symptoms associated with menopause (alternative agent) (off-label use): Note: Non-hormonal alternative in patients unable or unwilling to take estrogen (AACE [Goodman 2011]). Oral: Initial: 10 mg once daily, increase to 20 mg once daily after 4 weeks if symptoms not adequately controlled (Carpenter 2012; Freeman 2011; NAMS 2015).

Discontinuation of therapy:When discontinuing antidepressants, gradually taper the dose (eg, over 2 to 4 weeks) to minimize the incidence of withdrawal symptoms and allow for the detection of re-emerging symptoms (APA 2010; WFSBP [Bauer 2015]); antidepressants with a shorter half-life may need to be tapered more slowly (APA 2010) (eg, 4 weeks [Hirsch 2018a]). If intolerable withdrawal symptoms occur following a dose reduction, resume the previously prescribed dose and/or decrease dose at a more gradual rate (Shelton 2001). Selected patients (eg, those with a history of discontinuation syndrome) on long-term treatment (>6 months) may benefit from tapering over >3 months (WFSBP [Bauer 2015]). Evidence supporting ideal taper rates is limited (Shelton 2001; WFSBP [Bauer 2015]).

Switching antidepressants: Evidence for ideal antidepressant switching strategies is limited; strategies include cross-titration (gradually discontinuing the first antidepressant while at the same time gradually increasing the new antidepressant) and direct switch (abruptly discontinuing the first antidepressant and then starting the new antidepressant at an equivalent dose or lower dose and increasing it gradually). Cross-titration (eg, over 1 to 4 weeks depending upon sensitivity to discontinuation symptoms and adverse effects) is standard for most switches, but is contraindicated when switching to or from an MAOI. A direct switch may be an appropriate approach when switching to another agent in the same or similar class (eg, when switching between two SSRIs), when the antidepressant to be discontinued has been used for <1 week, or when the discontinuation is for adverse effects. When choosing the switch strategy, consider the risk of discontinuation symptoms, potential for drug interactions, other antidepressant properties (eg, half-life, adverse effects, and pharmacodynamics), and the degree of symptom control desired (Hirsch 2018b; Ogle 2013; WFSBP [Bauer 2013]).

Switching to or from an MAOI:

Allow 14 days to elapse between discontinuing an MAOI and initiation of escitalopram.

Allow 14 days to elapse between discontinuing escitalopram and initiation of an MAOI.

Dosing: Geriatric

Major depressive disorder (unipolar), generalized anxiety disorder: Oral: 10 mg once daily; lower initial doses of 5 mg once daily have been suggested for depression (VA/DoD 2016).

Discontinuation of therapy: Refer to adult dosing.

Switching antidepressants: Refer to adult dosing.

Dosing: Pediatric

Major depressive disorder (unipolar): Oral: Children ≥12 years of age: Initial: 10 mg once daily; dose may be increased to a maximum of 20 mg once daily after at least 3 weeks.

Discontinuation of therapy: Refer to adult dosing.

Switching antidepressants: Refer to adult dosing.

Dosing: Renal Impairment

Mild to moderate impairment: No dosage adjustment is necessary

Severe impairment: CrCl <20 mL/minute: Use with caution.

Dosing: Hepatic Impairment

10 mg once daily

Administration

Oral: Administer once daily (morning or evening), with or without food.

Cipralex MELTZ [Canadian product] should be dissolved on the tongue and swallowed without water.

Storage

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Cipralex MELTZ [Canadian product] should be stored in original package and protected from light.

Drug Interactions

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the antiplatelet effect of other Agents with Antiplatelet Properties. Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Management: Patients receiving selective serotonin reuptake inhibitors should be advised to avoid alcohol. Monitor for increased psychomotor impairment in patients who consume alcohol during treatment with selective serotonin reuptake inhibitors. Consider therapy modification

Amifampridine: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, both drugs have the potential to decrease the seizure threshold, possibly increasing the risk for seizures. Monitor therapy

Anticoagulants: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Apixaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Apixaban. Specifically, the risk for bleeding may be increased. Management: Carefully consider risks and benefits of this combination and monitor closely. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Aspirin: Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Aspirin. Monitor therapy

Blood Glucose Lowering Agents: Selective Serotonin Reuptake Inhibitors may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Boceprevir: May decrease the serum concentration of Escitalopram. Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Bromopride: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Avoid combination

BusPIRone: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Selective Serotonin Reuptake Inhibitors may decrease the metabolism of BusPIRone. Management: The combination of a selective serotonin reuptake inhibitor and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Cephalothin: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Cephalothin. Specifically, the risk for bleeding may be increased. Monitor therapy

Cimetidine: May increase the serum concentration of Escitalopram. Management: Consider using an alternative H2-antagonist to avoid the risk of escitalopram toxicity. Escitalopram Canadian product labeling recommends limiting escitalopram dose to 10 mg/day with concomitant use of cimetidine. Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Collagenase (Systemic): Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Collagenase (Systemic). Specifically, the risk of injection site bruising and/or bleeding may be increased. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP2C19 Inhibitors (Moderate): May decrease the metabolism of CYP2C19 Substrates (High risk with Inhibitors). Monitor therapy

CYP2C19 Inhibitors (Strong): May decrease the metabolism of CYP2C19 Substrates (High risk with Inhibitors). Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). Consider therapy modification

Cyproheptadine: May diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Monitor therapy

Dabigatran Etexilate: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Dabigatran Etexilate. Agents with Antiplatelet Properties may increase the serum concentration of Dabigatran Etexilate. This mechanism applies specifically to clopidogrel. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Dasatinib: May enhance the anticoagulant effect of Agents with Antiplatelet Properties. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Deoxycholic Acid: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Deoxycholic Acid. Specifically, the risk for bleeding or bruising in the treatment area may be increased. Monitor therapy

Desmopressin: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Desmopressin. Monitor therapy

Dextromethorphan: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Dextromethorphan. Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Dextromethorphan. Management: Avoid the concurrent use of dextromethorphan and SSRIs, particularly fluoxetine and paroxetine, when possible. The risk for this interaction may persist for several weeks following discontinuation of fluoxetine or paroxetine. Consider therapy modification

Dosulepin: Selective Serotonin Reuptake Inhibitors may increase the serum concentration of Dosulepin. Avoid combination

Edoxaban: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Edoxaban. Specifically, the risk of bleeding may be increased. Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Consider therapy modification

Fat Emulsion (Fish Oil Based): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

FLUoxetine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Glucosamine: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Bleeding may occur. Consider therapy modification

Hydroxychloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Ibritumomab Tiuxetan: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Ibritumomab Tiuxetan. Both agents may contribute to impaired platelet function and an increased risk of bleeding. Monitor therapy

Ibrutinib: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ioflupane I 123: Selective Serotonin Reuptake Inhibitors may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Limaprost: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Linezolid: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This could result in serotonin syndrome. Avoid combination

Lithium: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This could increase the risk of serotonin toxicity/serotonin syndrome. Management: This combination should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Macimorelin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methylene Blue: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Avoid combination

Methylene Blue: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Monitor therapy

Metoclopramide: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving metoclopramide with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification

MetyroSINE: May enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Monitor therapy

Mexiletine: Selective Serotonin Reuptake Inhibitors may decrease the metabolism of Mexiletine. Consider therapy modification

MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. While methylene blue and linezolid are expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Methylene Blue; Tedizolid. Avoid combination

Multivitamins/Fluoride (with ADE): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Nonselective): Selective Serotonin Reuptake Inhibitors may enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Management: Consider using alternative analgesics, when appropriate, and/or addition of a gastroprotective agent. Monitor patients closely for signs/symptoms of bleeding, and for evidence of diminished SSRI effectiveness with concurrent use. Consider therapy modification

Obinutuzumab: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Obinutuzumab. Specifically, the risk of serious bleeding-related events may be increased. Monitor therapy

Omega-3 Fatty Acids: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Omeprazole: May increase the serum concentration of Escitalopram. Management: Monitor for increased escitalopram toxicity with concomitant use of omeprazole. Recommendations for management of this interaction found in product labeling may differ by country. Consult appropriate labeling. Consider therapy modification

Opioid Analgesics: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Pentosan Polysulfate Sodium: May enhance the adverse/toxic effect of Agents with Antiplatelet Properties. Specifically, the risk of bleeding may be increased by concurrent use of these agents. Monitor therapy

Pentoxifylline: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Perhexiline: CYP2D6 Inhibitors (Weak) may increase the serum concentration of Perhexiline. Monitor therapy

Pimozide: Selective Serotonin Reuptake Inhibitors may enhance the adverse/toxic effect of Pimozide. Avoid combination

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Consider therapy modification

Probucol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Promazine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Prostacyclin Analogues: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

QTc-Prolonging Agents (Highest Risk): QTc-Prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of QTc-Prolonging Agents (Highest Risk). Avoid combination

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy

QTc-Prolonging Agents (Moderate Risk): May enhance the QTc-prolonging effect of other QTc-Prolonging Agents (Moderate Risk). Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Rivaroxaban: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Rivaroxaban. Management: Carefully consider risks and benefits of this combination and monitor closely; Canadian labeling recommends avoiding prasugrel or ticagrelor. Monitor therapy

Salicylates: Agents with Antiplatelet Properties may enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

Serotonin Reuptake Inhibitor/Antagonists: Selective Serotonin Reuptake Inhibitors may enhance the serotonergic effect of Serotonin Reuptake Inhibitor/Antagonists. This may cause serotonin syndrome. Management: Consider alternatives, and use conservative initial dosing. Monitor patients receiving these combinations for signs/symptoms of serotonin toxicity. Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: Escitalopram may decrease the serum concentration of Simeprevir. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Tedizolid: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Telaprevir: May decrease the serum concentration of Escitalopram. Monitor therapy

Thiazide and Thiazide-Like Diuretics: Selective Serotonin Reuptake Inhibitors may enhance the hyponatremic effect of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Thrombolytic Agents: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Thrombolytic Agents. Monitor therapy

Thyroid Products: Selective Serotonin Reuptake Inhibitors may diminish the therapeutic effect of Thyroid Products. Thyroid product dose requirements may be increased. Monitor therapy

Tipranavir: May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

TraMADol: Serotonin Modulators may enhance the adverse/toxic effect of TraMADol. The risk of seizures may be increased. TraMADol may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Escitalopram. Escitalopram may increase the serum concentration of Tricyclic Antidepressants. Management: Consider alternatives to this combination when possible. Monitor for adverse effects of tricyclic antidepressants (TCAs), including serotonin syndrome and QT-interval prolongation, when a TCA is being used in combination with escitalopram. Consider therapy modification

Tryptophan: May enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Avoid combination

Urokinase: Agents with Antiplatelet Properties may enhance the anticoagulant effect of Urokinase. Avoid combination

Vinflunine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Avoid combination

Vitamin E (Systemic): May enhance the antiplatelet effect of Agents with Antiplatelet Properties. Monitor therapy

Vitamin K Antagonists (eg, warfarin): Selective Serotonin Reuptake Inhibitors may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Xipamide: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Moderate Risk). Monitor therapy

Adverse Reactions

>10%:

Central nervous system: Headache (24%), insomnia (7% to 14%), drowsiness (4% to 13%)

Gastrointestinal: Nausea (15% to 18%), diarrhea (6% to 14%)

Genitourinary: Ejaculatory disorder (9% to 14%)

1% to 10%:

Central nervous system: Fatigue (2% to 8%), dizziness (4% to 7%), anorgasmia (2% to 6%), abnormal dreams (3%), lethargy (3%), paresthesia (2%), yawning (2%)

Dermatologic: Diaphoresis (3% to 8%)

Endocrine & metabolic: Decreased libido (3% to 7%), menstrual disease (2%)

Gastrointestinal: Xerostomia (4% to 9%), constipation (3% to 6%), dyspepsia (2% to 6%), decreased appetite (3%), vomiting (3%), abdominal pain (2%), flatulence (2%), toothache (2%)

Genitourinary: Impotence (2% to 3%), urinary tract infection (children ≥2%)

Neuromuscular & skeletal: Neck pain (≤3%), shoulder pain (≤3%), back pain (children ≥2%)

Respiratory: Flu-like symptoms (5%), rhinitis (5%), sinusitis (3%), nasal congestion (children ≥2%)

<1%, postmarketing, and/or case reports: Abdominal cramps, abnormal gait, acute renal failure, aggressive behavior, agitated depression, agitation, agranulocytosis, akathisia, alopecia, amnesia, anaphylaxis, anemia, angioedema, angle-closure glaucoma, anxiety, apathy, aplastic anemia, arthralgia, ataxia, atrial fibrillation, blurred vision, bradycardia, bronchitis, cardiac failure, cerebrovascular accident, chest pain, choreoathetosis, cough, deep vein thrombosis, delirium, delusions, depersonalization, dermatitis, diabetes mellitus, diplopia, dyskinesia, dysmenorrhea, dysphagia, dyspnea, dystonia, dysuria, ecchymoses, edema, epistaxis, erythema multiforme, extrapyramidal reaction, fever, flushing, gastroenteritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, hallucination, heartburn, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis, hot flash, hypercholesterolemia, hyperglycemia, hypermenorrhea, hyperprolactinemia, hypersensitivity reaction, hypertension, hypertensive crisis, hypoesthesia, hypoglycemia, hypokalemia, hyponatremia, hypoprothrombinemia, hypotension, immune thrombocytopenia, increased appetite, increased INR, increased liver enzymes, increased serum bilirubin, irritability, jaw tightness, lack of concentration, leukopenia, limb pain, migraine, myalgia, myasthenia, mydriasis, myocardial infarction, myoclonus, neuroleptic malignant syndrome (Stevens 2008), nightmares, nystagmus, orthostatic hypotension, palpitations, pancreatitis, panic, paranoia, Parkinsonian-like syndrome, phlebitis, priapism, prolonged Q-T interval on ECG, psychosis, pulmonary embolism, rectal hemorrhage, restless leg syndrome, rhabdomyolysis, seizure, serotonin syndrome, SIADH, sinus congestion, sinus headache, skin photosensitivity, skin rash, spontaneous abortion, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, syncope, tachycardia, tardive dyskinesia, thrombocytopenia, thrombosis, tinnitus, torsades de pointes, toxic epidermal necrolysis, tremor, urinary frequency, urinary retention, urticaria, ventricular arrhythmia, ventricular tachycardia, vertigo, visual disturbance, weight gain, withdrawal syndrome

ALERT: U.S. Boxed Warning

Suicidality and antidepressant drugs:

Antidepressants increased the risk compared with 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 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 with placebo in adults older than 24 years; there was a reduction in risk with antidepressants compared with placebo in adults 65 years and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Appropriately monitor patients of all ages who are started on antidepressant therapy and closely observe for clinical worsening, suicidality, or unusual changes in behavior. Advise families and caregivers of the need for close observation and communication with the health care provider. Escitalopram is not approved for use in pediatric patients younger than 12 years.

Warnings/Precautions

Major psychiatric warnings:

• Suicidal thinking/behavior: [US Boxed Warning]: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder (MDD) and other psychiatric disorders; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years. Closely monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1 to 2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient's family or caregiver should be instructed to closely observe the patient and communicate condition with health care provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription. Escitalopram is not FDA approved for use in children <12 years of age.

• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.

• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient's family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their health care provider if any of these symptoms or worsening depression or psychosis occur.

Concerns related to adverse effects:

• Bleeding risk: Use with caution in patients who are hemodynamically unstable. May impair platelet aggregation resulting in increased risk of bleeding events (including GI bleeding), particularly if used concomitantly with aspirin, NSAIDs, warfarin, or other anticoagulants. Bleeding related to SSRI or SNRI use has been reported to range from relatively minor bruising and epistaxis to life-threatening hemorrhage.

• Cardiovascular effects: Use has been associated with dose-dependent QT interval prolongation with doses of 10 mg and 30 mg/day in healthy subjects (mean change from baseline: 4.3 msec and 10.7 msec, respectively); prolongation of QT interval and ventricular arrhythmia (including torsades de pointes) have been reported, particularly in females with preexisting QT prolongation or other risk factors (eg, hypokalemia, other cardiac disease).

• CNS depression: Has a low potential to impair cognitive or motor performance; caution operating hazardous machinery or driving.

• Fractures: Bone fractures have been associated with antidepressant treatment. Consider the possibility of a fragility fracture if an antidepressant-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising (Rabenda 2013; Rizzoli 2012).

• Ocular effects: May cause mild pupillary dilation which in susceptible individuals can lead to an episode of narrow-angle glaucoma. Consider evaluating patients who have not had an iridectomy for narrow-angle glaucoma risk factors

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) has occurred with serotonergic agents (eg, SSRIs, SNRIs), particularly when used in combination with other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St John's wort, tryptophan) or agents that impair metabolism of serotonin (eg, MAO inhibitors intended to treat psychiatric disorders, other MAO inhibitors [ie, linezolid and intravenous methylene blue]). Monitor patients closely for signs of SS such as mental status changes (eg, agitation, hallucinations, delirium, coma); autonomic instability (eg, tachycardia, labile blood pressure, diaphoresis); neuromuscular changes (eg, tremor, rigidity, myoclonus); GI symptoms (eg, nausea, vomiting, diarrhea); and/or seizures. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

• Sexual dysfunction: May cause or exacerbate sexual dysfunction.

• SIADH and hyponatremia: SSRIs and SNRIs have been associated with the development of SIADH; hyponatremia has been reported rarely (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. Hyponatremia is reversible with discontinuation of treatment. Volume depletion and/or concurrent use of diuretics likely increases risk.

Disease-related concerns:

• Cardiovascular disease: Patients with a recent history of MI or unstable heart disease were excluded from clinical trials; use with caution.

• Hepatic impairment: Use with caution in patients with hepatic impairment; clearance is decreased and plasma concentrations are increased; a lower dosage may be needed.

• Mania/hypomania: May precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder. Escitalopram is not FDA approved for the treatment of bipolar depression.

• Metabolic disease: Use with caution; limited data in patients with altered metabolism.

• Renal impairment: Use with caution in patients with severe renal impairment.

• Seizure disorders: Use with caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage or alcoholism.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• CYP2C19 poor metabolizers: Escitalopram systemic exposure may be increased in CYP2C19 poor metabolizers.

• Elderly: Bioavailability and half-life are increased by 50% in the elderly.

Dosage form specific issues:

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Discontinuation syndrome: Abrupt discontinuation or interruption of antidepressant therapy has been associated with a discontinuation syndrome. Symptoms arising may vary with antidepressant however commonly include nausea, vomiting, diarrhea, headaches, light-headedness, dizziness, diminished appetite, sweating, chills, tremors, paresthesias, fatigue, somnolence, and sleep disturbances (eg, vivid dreams, insomnia). Less common symptoms include electric shock-like sensations, cardiac arrhythmias (more common with tricyclic antidepressants), myalgias, parkinsonism, arthralgias, and balance difficulties. Psychological symptoms may also emerge such as agitation, anxiety, akathisia, panic attacks, irritability, aggressiveness, worsening of mood, dysphoria, mood lability, hyperactivity, mania/hypomania, depersonalization, decreased concentration, slowed thinking, confusion, and memory or concentration difficulties. Greater risks for developing a discontinuation syndrome have been associated with antidepressants with shorter half-lives, longer durations of treatment, and abrupt discontinuation. For antidepressants of short or intermediate half-lives, symptoms may emerge within 2 to 5 days after treatment discontinuation and last 7 to 14 days (APA 2010; Fava 2006; Haddad 2001; Shelton 2001; Warner 2006).

• Electroconvulsive therapy (ECT): Use with caution; no clinical studies have assessed the combined use of escitalopram and electroconvulsive therapy; may increase the risks (eg, cognitive adverse effects) associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.

Monitoring Parameters

Mental status for depression, suicidal ideation (especially at the beginning of therapy or when doses are increased or decreased), anxiety, social functioning, mania, panic attacks; akathisia; signs/symptoms of serotonin syndrome

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Escitalopram crosses the placenta and is distributed into the amniotic fluid. An increased risk of teratogenic effects, including cardiovascular defects, may be associated with maternal use of escitalopram or other SSRIs; however, available information is conflicting. Nonteratogenic effects in the newborn following SSRI/SNRI exposure late in the third trimester include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo- or hypertonia, hyper-reflexia, jitteriness, irritability, constant crying, and tremor. Symptoms may be due to the toxicity of the SSRIs/SNRIs or a discontinuation syndrome and may be consistent with serotonin syndrome associated with SSRI treatment. Persistent pulmonary hypertension of the newborn (PPHN) has also been reported with SSRI exposure. The long-term effects of in utero SSRI exposure on infant development and behavior are not known. Escitalopram is the S-enantiomer of the racemic derivative citalopram; also refer to the Citalopram monograph.

Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of escitalopram may be altered. The ACOG recommends that therapy with SSRIs or SNRIs during pregnancy be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary health care provider, and pediatrician. According to the American Psychiatric Association (APA), the risks of medication treatment should be weighed against other treatment options and untreated depression. For women who discontinue antidepressant medications during pregnancy and who may be at high risk for postpartum depression, the medications can be restarted following delivery. Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy.

Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, dizziness, diarrhea, constipation, dry mouth, insomnia, sweating a lot, flu-like signs, headache, loss of strength and energy, fatigue, rhinorrhea, or yawning. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), agitation, panic attacks, mood changes, signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), seizures, chills, sexual dysfunction, decreased libido, vision changes, eye pain, eye redness, eye edema, signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

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