psychiatric disorders with escitalopram or within 14 days of discontinuation Use of escitalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders Starting escitalopram in a patients being treated with MAOIs such as linezolid or IV methylene blue Cautions Increased risk of suicidal thoughts and behaviors in adolescents and young adults; monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during initial few months of drug therapy Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy In a study in normal volunteers, escitalopram10 mg/day did not impair intellectual function or psychomotor performance; because any psychoactive drug may impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including automobiles, until they are they know how the drug affects their cognition Increased risk of bleeding events related to drugs that interfere with serotonin reuptake; symptoms may include ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages; for patients taking warfarin, carefully monitor international normalized ratio Limited information on use in patients with concomitant illness; caution advised with diseases or conditions that alter metabolism or hemodynamic responses Serotonin syndrome Serotonin syndrome reported with SNRIs and SSRIs, particularly when coadministered with other serotonergic drugs Serotonin syndrome symptoms may include mental status changes (eg, agitation, hallucinations, delirium, and coma), autonomic instability (eg, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea); monitor for emergence of serotonin syndrome Hyponatremia Hyponatremia may occur with SSRIs and SNRIs In many cases, hyponatremia appears to be result of syndrome of inappropriate antidiuretic hormone secretion (SIADH), and was reversible when discontinued Cases with serum sodium <110 mmol/L reported Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs; also, patients taking diuretics or are otherwise volume depleted may be at greater risk Consider discontinuation if symptomatic hyponatremia occurs and institute appropriate medical intervention Signs and symptoms include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls Signs and symptoms associated with more severe and/or acute cases include hallucination, syncope, seizure, coma, respiratory arrest, and death Seizures Anticonvulsant effects of racemic citalopram observed in animal studies; however, escitalopram has not been systematically evaluated in patients with a seizure disorder Patients with seizures were excluded from clinical studies during the product's premarketing testing In clinical trials, cases of convulsion reported in association with escitalopram treatment Introduce SSRIs and SNRIs with care in patients with history of seizures Sexual dysfunction Use may cause symptoms of sexual dysfunction in both male and female patients; inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider In males, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction In females SSRI use may result in decreased libido and delayed or absent orgasm Inquire about sexual function before initiating therapy and inquire specifically about changes in sexual function during treatment, as it may not be spontaneously reported Obtain detailed history (including timing of symptom onset) to assess other causes, including underlying psychiatric disorder Discuss potential management strategies to support patients in making informed decisions about treatment Discontinuation syndrome Spontaneous reports of adverse events occurring upon discontinuation of SSRIs and SRNIs, particularly when abrupt Symptoms may include dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesia such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania Although these events are generally self-limiting, there have been reports of serious discontinuation symptoms Monitor for these symptoms when discontinuing; gradually reduce dose rather than abruptly discontinue when possible If intolerable symptoms occur after decreasing dose or upon discontinuation, consider resuming previously prescribed dose and subsequently decreasing dose at a more gradual rate Activation of mania or hypomania Activation of mania/hypomania reported in a small proportion of patients with major affective disorders treated with antidepressants Before initiating, screen for any personal or family history of bipolar disorder, mania, or hypomania Drug interaction overview Escitalopram is a CYP3A4 and CYP2C19 substrate MAOIs Contraindicated Coadministration or within 14 days of stopping either a MAOI or escitalopram is contraindicated owing to increased risk for serotonin syndrome Pimozide Contraindicated A single dose of pimozide 2 mg coadministered with racemic citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of ~10 msec compared with pimozide given alone Racemic citalopram did not alter the mean AUC or Cmax of pimozide; mechanism of this pharmacodynamic interaction is unknown Serotonergic drugs Caution, monitor Risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SSRIs and SNRIs both when taken alone, but especially when coadministered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort); if symptoms occur, discontinue therapy and initiate supportive treatment If concomitant use of escitalopram with other serotonergic drugs is clinically warranted, be aware of the increased risk for serotonin syndrome, particularly during treatment initiation and dose increases Antiplatelet agents or anticoagulants Caution, monitor May impair platelet aggregation that can result in increased risk of bleeding events including GI bleeding especially if taken concomitantly with aspirin, warfarin, or NSAIDs CNS depressants Caution, monitor Owing to primary CNS effects, caution when coadministered with other centrally acting drugs Did not potentiate cognitive and motor effects of alcohol in a clinical trial; however, as with other psychotropic medications, alcohol is not recommended CYP3A4 and -2C19 inhibitors Insignificant interaction Coadministration of escitalopram 20 mg and ritonavir 600 mg, a potent CYP3A4 inhibitor, did not significantly affect escitalopram pharmacokinetics Pregnancy Available data from published epidemiologic studies and postmarketing reports have not established an increased risk of major birth defects or miscarriage There are risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (SSRIs) during pregnancy There are risks associated with untreated depression in pregnancy Pregnancy exposure registry There is a pregnancy exposure registry that monitors outcomes in women exposed to antidepressants during pregnancy Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185, OR Online at womensmentalhealth.org/clnical-and-research-programs/pregnancyregistry/antidepressants/ Neonates exposed to escitalopram and other SSRIs/SNRIs Neonates exposed to SSRIs/SNRIs late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding Such complications can arise immediately upon delivery Reported clinical findings include respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying These features are consistent with toxic effects of SSRIs and SNRIs or, possibly, drug discontinuation syndrome Disease-associated maternal risk and/or embryo/fetal risk Women who discontinue antidepressants are more likely to experience a relapse of major depression than women who continue antidepressants This finding is from a prospective longitudinal study of 201 pregnant women with a history of major depression, who were euthymic and taking antidepressants at the beginning of pregnancy Consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum Lactation Escitalopram is excreted in human breast milk There are reports of excessive sedation, restlessness, agitation, poor feeding and poor weight gain in infants exposed to escitalopram, through breast milk Limited data from women taking 10-20 mg escitalopram showed that exclusively breast-fed infants receive a ~3.9% of the maternal weight-adjusted dose of escitalopram and 1.7% of the maternal weight-adjusted dose of desmethylcitalopram Caution should be exercised and breastfeeding infants should be observed for adverse reactions when administered to a nursing womanPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action S-enantiomer of racemic citalopram; inhibits the reuptake of serotonin, with little or no effect on norepinephrine or dopamine reuptake Absorption Peak plasma time: 5 hr (single 20-mg dose) Bioavailability: 80% (IV citalopram) Distribution Protein bound: 56% Vd: 12 L/kg (citalopram) Metabolism CYP3A4, CYP2C19 Metabolites: Insignificant potency Enzymes inhibited: CYP2D6 (moderate) Elimination Half-life: 27-32 hr Dialyzable: No Renal clearance: 42 mL/min Total body clearance: 600 mL/min Excretion: Urine (8%) Oral Administrationº Administer once daily, in the morning or evening, with or without food Storage Store at 20-25ºC (68-77ºF); excursions permitted to 15-30°C (59-86ºF) BRAND FORM. UNIT PRICE PILL IMAGE escitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 5 mg/5 mL solutionescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 20 mg tabletescitalopram oxalate oral- 10 mg tabletescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 5 mg/5 mL solutionescitalopram oxalate oral- 5 mg/5 mL solutionescitalopram oxalate oral- 5 mg/5 mL solutionescitalopram oxalate oral- 5 mg tabletescitalopram oxalate oral- 10 mg tabletLexapro oral- 20 mg tabletLexapro oral- 10 mg tabletLexapro oral- 5 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationescitalopram oxalate oral ESCITALOPRAM - ORAL (ES-sye-TAL-oh-pram) COMMON BRAND NAME(S): Lexapro WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. USES: Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI). It may improve your energy level and feelings of well-being and decrease nervousness. HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking escitalopram and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning or evening. The dosage is based on your medical condition, response to treatment, age, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.To reduce your risk of side effects, your doctor may direct you to start