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Selective Serotonin Reuptake Inhibitor Antidepressants, SSRIs
BOXED WARNING
Children, growth inhibition, suicidal ideation
Safety and efficacy have not been established in pediatric populations for any indication except for the treatment of major depressive disorder in children and adolescents 12 years of age and older. All antidepressants include a boxed warning detailing the risk of suicide in pediatric patients. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4,400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with SSRIs and other antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in children or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increase or decrease. It is unknown if the suicidality risk in children and young adults extends to longer-term therapy (i.e., beyond several months). The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as obsessive-compulsive disorder (OCD). All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with escitalopram. In patients who exhibit changes in symptoms, worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. All antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. The potential for growth inhibition in pediatric patients should be monitored during SSRI therapy. Monitor height and weight periodically while the patient is receiving escitalopram. Data are inadequate to determine whether the chronic use of SSRIs causes long-term growth inhibition; however, decreased weight gain has been observed in children and adolescents receiving escitalopram.
DEA CLASS
DESCRIPTION
Selective serotonin reuptake inhibitor; the S (+) enantiomer of citalopram.
FDA-approved for treating major depression in adults and adolescents and generalized anxiety disorder in adults; used off-label for anxiety disorders.
Requires close monitoring in pediatrics and young adults due to increased risk of suicidality during the initial stages of treatment.
COMMON BRAND NAMES
Escitalopram/Lexapro Oral Sol: 5mg, 5mL
Escitalopram/Lexapro Oral Tab: 5mg, 10mg, 20mg
DOSAGE & INDICATIONS
For the treatment of major depression.
Oral dosage
Adults
10 mg PO once daily initially. A dosage range of 10 to 20 mg/day is effective, but trials failed to demonstrate a greater benefit of 20 mg over 10 mg dosing. May increase to 20 mg PO once daily after a minimum of 1 week if clinically indicated. Max: 20 mg/day PO. Periodically reassess to determine the need for ongoing maintenance treatment. Head-to-head therapeutic interchange studies between escitalopram and citalopram are not available; however, studies have shown that the 10 mg/day of escitalopram is as effective as 20 mg/day or 40 mg/day of citalopram.
Geriatric Adults
10 mg PO once daily. Periodically reassess to determine the need for ongoing maintenance treatment.
Children and Adolescents 12 years and older
10 mg PO once daily is the recommended dose. Efficacy has been demonstrated in the range of 10 to 20 mg/day. The dose may be increased to 20 mg/day PO after 3 weeks of treatment if clinically indicated. Periodically reassess to determine the need for ongoing maintenance treatment.
For the treatment of generalized anxiety disorder (GAD), as well as other anxiety disorders such as panic disorder or social phobia (social anxiety disorder).
For the treatment of generalized anxiety disorder (GAD).
Oral dosage
Adults
10 mg PO once daily initially. If clinically indicated, the dose may be increased to 20 mg/day PO after a minimum of 1 week. Periodically re-evaluate the need for ongoing therapy.
Geriatric Adults
In general, the initial and maximum recommended dose in geriatric patients is 10 mg/day PO. Periodically re-evaluate the need for ongoing therapy.
For the treatment of panic disorder (panic attacks) with or without agoraphobia.
Oral dosage
Adults
5 mg PO once daily initially, then titrated to 10 to 20 mg/day PO. An unpublished, double-blind, 10-week study (n = 247) suggests escitalopram can reduce the number and severity of panic attacks. Symptoms improved within 4 weeks. By the end of the study, half of escitalopram patients were completely free of attacks vs. 39% of those in the placebo group. Mean changes in the Panic and Agoraphobia Scale vs. placebo were significant at 4 weeks and continued to improve over the 10-week study period. Reductions in anxiety were also significant. Further clinical trials are needed to define the correct dose, safety and efficacy profile, and comparative use of escitalopram for panic disorders.
Geriatric Adults
Initially, 5 mg PO once daily. The maximum suggested dose for most geriatric patients is 10 mg/day PO. An unpublished, double-blind, 10-week study in adults (n = 247) suggests escitalopram can reduce the number and severity of panic attacks. Symptoms improved within 4 weeks. Further clinical trials are needed to define the correct dose, safety and efficacy profile, and comparative use of escitalopram for panic disorders.
For the treatment of social phobia (social anxiety disorder).
Oral dosage
Adults
Results from 1 large placebo-controlled study of 839 patients showed that doses of 5 mg to 20 mg/day PO were safe and effective in the short- and long-term treatment of social anxiety disorder.
Geriatric Adults
Results from 1 large placebo-controlled study of 839 adult patients showed that doses of 5 mg/day to 20 mg/day PO were safe and effective in the short- and long-term treatment of social anxiety disorder. The recommended maximum dose for most geriatric patients is 10 mg/day PO.
Children and Adolescents 10 years and older
5 mg/day PO initially, titrated up to 10 to 20 mg/day PO. In 1 small open-label study (n = 20), escitalopram was initiated at 5 mg/day PO, increased to 10 mg/day after the first week, and subsequently titrated in 5 mg increments up to a maximum of 20 mg/day based upon efficacy and tolerability. Eighteen patients completed the 12-week trial, and 65% were considered responders. At study end, 60% of patients were receiving 10 mg/day, 20% were receiving 15 mg/day, and 20% were receiving 20 mg/day; the mean daily dose was 13 mg/day. Patients should be periodically reassessed to determine the need for ongoing maintenance treatment.
For the treatment of irritability associated with autistic disorder.
Oral dosage
Children and Adolescents 6 years and older
Effective dose range not established. Doses up to 20 mg/day PO have been studied. Results from 1 open-label, forced titration study (n = 28) suggest that escitalopram may be effective in treating some behavioral symptoms associated with autism such as irritability; however, there was large individual variability in the final dose (ranging from no treatment up to 20 mg/day). The mean final dose was 11.1 mg/day PO. The response rate was 61%, with response defined as a 50% or greater reduction in the Aberrant Behavior Checklist (ABC)-Community Version Irritability score. There was no relationship between weight and final dose. Of the 5 patients who did not complete the 10-week study, 2 were responders but had significant continuing hyperactivity, 1 was a non-responder and had continuing obsessions and compulsions, and 2 had symptoms of disinhibition and aggression. Patients should be periodically reassessed to determine the need for ongoing maintenance treatment.
Indicates off-label use
Children
12 years: 20 mg/day PO.
6 to 11 years: Safety and efficacy have not been established; however, doses up to 20 mg/day PO have been used for anxiety and pervasive developmental disorders.
1 to 5 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
DOSING CONSIDERATIONS
10 mg PO once daily is the recommended dose for patients with hepatic impairment.
Renal Impairment
CrCl 20 mL/minute or more: No dosage adjustment is necessary.
CrCl less than 20 mL/minute: Specific guidelines for dosage adjustments are not available; use with caution.
ADMINISTRATION
May administer escitalopram with or without food. If nausea occurs, administer after a meal.
Oral Solid Formulations
Tablets: The 10 mg and 20 mg tablets are scored and may be cut in half if needed.
Oral Liquid Formulations
Oral solution: Measure dosage with an oral syringe or calibrated measuring device to ensure dose accuracy.
STORAGE
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
Citalopram hypersensitivity, escitalopram hypersensitivity
Escitalopram is contraindicated for use in patients with an escitalopram hypersensitivity, citalopram hypersensitivity, or hypersensitivity to any of the formulation components. Escitalopram is the active isomer of racemic citalopram; therefore the two drugs should not be taken together as this would constitute duplicative therapy.
Abrupt discontinuation
Avoid abrupt discontinuation of escitalopram if possible. Gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of potential discontinuation symptoms. The most frequent SSRI discontinuation symptoms include dizziness, vertigo, nausea, vomiting, flu-like symptoms, sensory disturbances (e.g., paresthesias, electric shock sensation), sleep disturbances, irritability, anxiety, and/or agitation. Discontinuation symptoms are more likely to occur after withdrawal of SSRIs with a short half-life.
Bipolar disorder, mania
All effective antidepressants can transform depression into mania or hypomania in predisposed individuals. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. If a patient develops manic symptoms, escitalopram should be withheld, and appropriate therapy initiated to treat the manic symptoms. Additionally, depression may be the presenting symptom of a mixed/manic episode of bipolar disorder. Patients should be adequately screened for bipolar disorder prior to initiating an antidepressant. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Patients with depression or comorbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes. Caregivers should be advised to closely observe the patient on a daily basis and to communicate immediately with the prescriber the emergence of agitation, irritability, unusual changes in behavior, or, emergence of suicidality. It should be noted that escitalopram is not approved for use in treating bipolar depression.
Children, growth inhibition, suicidal ideation
Safety and efficacy have not been established in pediatric populations for any indication except for the treatment of major depressive disorder in children and adolescents 12 years of age and older. All antidepressants include a boxed warning detailing the risk of suicide in pediatric patients. A causal role has been established for antidepressants in inducing suicidality in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n = 4,400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Pooled analysis of short-term clinical trials during early phase treatment with SSRIs and other antidepressants in young adults (18 to 24 years) also showed an increased risk of suicidal thinking and behavior. The clinical need for an antidepressant in children or young adults for any use must be weighed against the risk of increased suicidality; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increase or decrease. It is unknown if the suicidality risk in children and young adults extends to longer-term therapy (i.e., beyond several months). The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as obsessive-compulsive disorder (OCD). All patients with a history of suicidal ideation or behaviors and those with a prominence of suicidal ideation prior to treatment are considered at an increased risk for suicidal ideation or attempts, and should be closely monitored during treatment with escitalopram. In patients who exhibit changes in symptoms, worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. All antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. The potential for growth inhibition in pediatric patients should be monitored during SSRI therapy. Monitor height and weight periodically while the patient is receiving escitalopram. Data are inadequate to determine whether the chronic use of SSRIs causes long-term growth inhibition; however, decreased weight gain has been observed in children and adolescents receiving escitalopram.
MAOI therapy
Escitalopram is contraindicated for concomitant use in patients receiving MAOI therapy, due to the risk for serotonin syndrome. Escitalopram should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI intended to treat psychiatric disorders. Conversely, at least 14 days should be allowed after stopping escitalopram before starting an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram in a patient who is being treated with linezolid or intravenous methylene blue. Serotonin syndrome has been reported with SSRIs and SNRIs, including escitalopram, 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 such symptoms occur, discontinue escitalopram and initiate supportive treatment. If concomitant use of escitalopram with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
Electroconvulsive therapy (ECT), seizure disorder, seizures
Escitalopram should be used with caution in patients with a history of seizure disorder. These patients were excluded from clinical studies during the premarketing testing. Seizures have been reported rarely in patients taking SSRIs. In clinical trials of escitalopram, cases of convulsion have been reported in association with escitalopram treatment. Escitalopram's effects during electroconvulsive therapy (ECT) have not been evaluated in clinical studies to date.
Dehydration, hyponatremia, hypovolemia
Selective serotonin reuptake inhibitors (SSRIs), including escitalopram, may cause hyponatremia. This is frequently the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), and is reversible when the causative agent is discontinued. In some cases, serum sodium levels less than 110 mmol/L have been reported. Older patients, those receiving diuretics or prone to dehydration, and those who are otherwise volume depleted (e.g., hypovolemia) appear to be at greatest risk. Hyponatremia may manifest as headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness which may result in falls. Severe manifestations include hallucinations, syncope, seizure, coma, respiratory arrest, and death. Symptomatic hyponatremia may require discontinuation of escitalopram, as well as implementation of the appropriate medical interventions.
Alcoholism, bradycardia, cardiac arrhythmias, cardiac disease, coronary artery disease, diabetes mellitus, females, heart failure, hypertension, hypocalcemia, hypokalemia, hypomagnesemia, long QT syndrome, malnutrition, myocardial infarction, QT prolongation, thyroid disease
In rare instances, QT prolongation and torsade de pointes (TdP) have been reported during therapeutic use of escitalopram and following overdose. Because escitalopram is considered a drug with a known risk of TdP, use is not recommended in patients with congenital long QT syndrome. Escitalopram has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable cardiac disease; patients with these conditions were generally excluded from clinical studies during premarketing testing. Use escitalopram with caution in patients with cardiac disease or other conditions that may increase the risk of QT prolongation including cardiac arrhythmias, heart failure, bradycardia, myocardial infarction, hypertension, coronary artery disease, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances. Females, elderly patients, patients with diabetes mellitus, thyroid disease, malnutrition, alcoholism, or hepatic dysfunction may also be at increased risk for QT prolongation. It is advisable to correct electrolyte imbalances prior to treatment initiation. Because QT prolongation can occur following an overdose, an electrocardiogram should be obtained in cases of overdose.
Hepatic disease
Escitalopram should be used with caution in patients with hepatic disease because the drug is extensively metabolized in the liver, resulting in decreased clearance and increased plasma concentrations in patients with hepatic dysfunction. A lower maximum escitalopram dosage is recommended for patients with hepatic dysfunction. Patients with hepatic dysfunction may also be at increased risk for QT prolongation.
Renal failure, renal impairment
Excretion of unchanged escitalopram in the urine is a minor route of elimination. Ten percent of escitalopram is excreted unchanged in the urine. Escitalopram should be used with caution in patients with severe renal impairment (i.e., CrCl less than 20 mL/minute) until pharmacokinetic data are available for this population. There is no information on the use of escitalopram in patients with chronic renal failure who receive hemodialysis.
Anticoagulant therapy, bleeding, thrombolytic therapy
Monitor patients taking an SSRI for signs and symptoms of bleeding. Platelet aggregation may be impaired by selective serotonin reuptake inhibitors (SSRIs) due to platelet serotonin depletion, possibly increasing the risk of a bleeding complication (e.g., gastrointestinal bleeding, ecchymoses, epistaxis, hematomas, petechiae, hemorrhage). Concurrent use of aspirin, NSAIDs, anticoagulant therapy, thrombolytic therapy, or other medications that enhance bleeding potential may increase this risk. Patients taking escitalopram should be instructed to promptly report any bleeding events to the practitioner.
Bone fractures, osteoporosis
Use selective serotonin reuptake inhibitors (SSRIs), including escitalopram, cautiously in patients with osteoporosis. Epidemiological studies on bone fracture risk following exposure to SSRIs have reported an association between SSRI treatment and bone fractures. It is unknown to what extent fracture risk is directly attributable to SSRI treatment. If an escitalopram-treated patient presents with unexplained bone pain, point tenderness, swelling, or bruising, consider the possibility of a fragility fracture. Patients at risk for osteoporosis, such as postmenopausal females, may benefit from more frequent monitoring of bone density during long-term use of an SSRI.
Closed-angle glaucoma, increased intraocular pressure
Caution is recommended when prescribing escitalopram to patients with closed-angle glaucoma. The pupillary dilation that can occur with antidepressants may precipitate a closed-angle glaucoma attack in patients with anatomically narrow angles who do not have a patent iridectomy. An acute attack of closed-angle glaucoma is considered a medical emergency because the increased intraocular pressure is rapid and severe, and may quickly result in blindness if left untreated.
Akathisia
The use of escitalopram or other SSRIs has been associated with the development of akathisia, which is characterized by an inner sense of restlessness and psychomotor agitation such as an inability to sit or stand still usually associated with subjective distress. This is most likely to occur within the first few weeks of treatment. It is generally recommended to discontinue SSRI treatment if akathisia occurs.
Anorexia nervosa
Decreased appetite and weight loss have been observed during administration of SSRIs. Therefore, caution is advisable when administering escitalopram to patients with anorexia nervosa or other conditions where weight loss is undesirable.
Driving or operating machinery, ethanol ingestion
Because any psychoactive drug may impair judgment, thinking, or motor skills, patients should use caution when driving or operating machinery, until the full effect of escitalopram is determined. Although escitalopram has not been shown to increase the impairment of mental and motor skills caused by alcohol, patients should be advised to avoid ethanol ingestion while taking escitalopram. Additionally, other coadministered centrally-acting drugs may augment cognitive impairment.
Neonates, pregnancy
There are no adequate and well-controlled studies in pregnant women; escitalopram should be used in pregnancy only when the benefits to the mother outweigh the potential risk to the fetus. There is some evidence that SSRI use may cause non-teratogenic fetal harm during human pregnancy. Neonates exposed to escitalopram and other SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Symptoms have included 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 either serotonin syndrome or, possibly, a drug discontinuation syndrome. Epidemiologic reports suggest a possible association between maternal use of SSRIs after 20 weeks gestation and the development of persistent pulmonary hypertension (PPHN) of the newborn. More recent retrospective studies have not shown an increased risk of PPHN with SSRI exposure. In December 2011, the FDA issued a safety announcement stating that based on conflicting data, an increased risk of PPHN from SSRI exposure cannot be determined. The FDA advises that healthcare professionals should not alter their current practice of treating depression in pregnancy at this time. Women who are pregnant, or are planning a pregnancy, and currently taking escitalopram should consult with their physician about whether to continue taking it. When treating a pregnant woman with an SSRI during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. If clinically feasible, tapering of the medication prior to delivery may be considered. A prospective study of pregnant women receiving antidepressant treatment found that only 26% of those maintained on their antidepressant had relapsed versus 68% of those who had discontinued their medication. Increasing evidence suggests an association between antidepressant use during pregnancy and a subsequent diagnosis of autism spectrum disorder (ASD) in the offspring. In 2 separate population based case-control studies, an approximate 2-fold increased risk of autism spectrum disorder was observed. One study found the increased risk was associated only with SSRI use, while the other study found an increased risk associated with use of SSRIs and tricyclic antidepressants. In rat embryo/fetal developmental studies, escitalopram has been shown to have adverse effects on embryo/fetal and postnatal development when administered at doses 56 times or more the human maximum therapeutic dose (20 mg/m2/day). Decreased fetal body weight and delays in ossification were noted. Maternal toxicity (decreased feeding and decreased weight gain) was present at all dose levels. The developmental no effect dose of 56 mg/kg/day is roughly 28 times the recommended human dose. No teratogenicity was noted at any escitalopram dose; however, teratogenicity has been observed in citalopram animal studies. In general, animal studies have shown that SSRIs down-regulate the serotonin receptors in the fetal cortex and that these changes can be present for a period of time after birth. The effect of escitalopram on labor and delivery is unknown.
Breast-feeding
Use escitalopram with caution during breast-feeding because the drug is excreted into human breast milk. One study assessing escitalopram breast milk concentrations from 8 women taking escitalopram 10 to 20 mg daily estimated that exclusively breast-fed infants would receive 3.9% and 1.7% of the maternal weight-adjusted dose of escitalopram and its active metabolite desmethylescitalopram, respectively. Assessments of the infants in this study revealed normal development after a median of 55 days of escitalopram exposure (range 23 to 240 days). There were 2 reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breast-feeding from a racemic citalopram-treated mother; in 1 case, the infant was reported to recover completely upon discontinuation of racemic citalopram by the mother and, in the second case, no follow-up information was available. A case report has noted infant sleep disturbances; the effect subsided after dividing the mothers medication in 2 doses daily and replacing 2 of the daily infant feeds with formula. Patients should advise their physician of their intention to breast-feed. If escitalopram must be continued during lactation due to the benefit of the drug to the mother, it has been suggested that infant breast-feedings be avoided during the times of maximum maternal serum concentrations (i.e., within 4 hours of the daily dose). If agreeable with the mother and health care provider, the mother may pump breast-milk during times of lowest maternal serum concentrations (right before the next dose) and use this breast milk for feedings during the times of maximum maternal serum concentrations. Also, substitution of formula during times of maximal escitalopram concentrations should help limit the potential for adverse effects in the infant. Alternatively, discontinuation of escitalopram during lactation or the use of formula for all feeds may be indicated. A pooled analysis found that maternal use of sertraline, along with nortriptyline and paroxetine, usually produced undetectable or low drug concentrations in infant serum and, therefore, may be the preferred antidepressants in breast-feeding mothers. Consider the benefits of breast-feeding, the risk of potential drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding baby experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Geriatric
In clinical trials with escitalopram, 31% of patients were age 60 or older, 23% were 65 or older, and 10% were 75 or older. Greater sensitivity of the geriatric patient to escitalopram may occur; a lower dosage has been recommended for the geriatric adult. Selective serotonin reuptake inhibitors (SSRIs) may cause hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH); elderly patients appear to be at greater risk. According to the Beers Criteria, SSRIs are considered potentially inappropriate medications (PIMs) in elderly patients with a history of falls or fractures and should be avoided, unless safer alternatives are not available, since SSRIs can produce ataxia, impaired psychomotor function, syncope, and additional falls; if escitalopram must be used, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk. In addition, the Beers expert panel recommends caution when using SSRIs in older adults because SSRIs can cause or exacerbate hyponatremia and SIADH and the elderly are at increased risk of developing these conditions. Sodium levels should be closely monitored when starting or changing dosages in older adults. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of antidepressants in residents of long-term care facilities. According to OBRA, the duration of therapy should be in accordance with pertinent literature for the condition being treated, including clinical practice guidelines. All residents being treated for depression with any antidepressant should be monitored closely for worsening of depression and/or suicidal behavior or thinking, especially during initiation of therapy and during dose changes. Antidepressants may cause dizziness, nausea, diarrhea, anxiety, nervousness, insomnia, somnolence, weight gain, anorexia, or increased appetite. Many of these effects can increase the risk for falls. Prior to discontinuation, many antidepressants may need a taper to avoid a withdrawal syndrome. Concurrent use of 2 or more antidepressants may increase the risk of side effects; in such cases there should be documentation of expected benefits that outweigh the associated risks and monitoring for any increase in side effects. Monitoring should consist of a review for continued need at least quarterly, and documentation of the rationale for continuation. When the drug is being used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt to taper the medication as outlined in the OBRA guidelines, unless a taper is clinically contraindicated.
ADVERSE REACTIONS
pancreatitis / Delayed / Incidence not known
tardive dyskinesia / Delayed / Incidence not known
seizures / Delayed / Incidence not known
suicidal ideation / Delayed / Incidence not known
SIADH / Delayed / Incidence not known
hemolytic anemia / Delayed / Incidence not known
agranulocytosis / Delayed / Incidence not known
GI bleeding / Delayed / Incidence not known
aplastic anemia / Delayed / Incidence not known
heart failure / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
hypertensive crisis / Early / Incidence not known
torsade de pointes / Rapid / Incidence not known
thrombosis / Delayed / Incidence not known
atrial fibrillation / Early / Incidence not known
stroke / Early / Incidence not known
myocardial infarction / Delayed / Incidence not known
ventricular tachycardia / Early / Incidence not known
angioedema / Rapid / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
pulmonary embolism / Delayed / Incidence not known
visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known
hepatic failure / Delayed / Incidence not known
hepatic necrosis / Delayed / Incidence not known
fetal abortion / Delayed / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
rhabdomyolysis / Delayed / Incidence not known
serotonin syndrome / Delayed / Incidence not known
bone fractures / Delayed / Incidence not known
persistent pulmonary hypertension of the newborn / Delayed / Incidence not known
neonatal abstinence syndrome / Early / Incidence not known
Moderate
impotence (erectile dysfunction) / Delayed / 2.0-2.0
dysphagia / Delayed / Incidence not known
akathisia / Delayed / Incidence not known
choreoathetosis / Delayed / Incidence not known
pseudoparkinsonism / Delayed / Incidence not known
dysarthria / Delayed / Incidence not known
ataxia / Delayed / Incidence not known
migraine / Early / Incidence not known
myoclonia / Delayed / Incidence not known
dystonic reaction / Delayed / Incidence not known
nystagmus / Delayed / Incidence not known
amnesia / Delayed / Incidence not known
delirium / Early / Incidence not known
psychosis / Early / Incidence not known
depression / Delayed / Incidence not known
impulse control symptoms / Delayed / Incidence not known
confusion / Early / Incidence not known
mania / Early / Incidence not known
hallucinations / Early / Incidence not known
hostility / Early / Incidence not known
hyponatremia / Delayed / Incidence not known
platelet dysfunction / Delayed / Incidence not known
hypoprothrombinemia / Delayed / Incidence not known
anemia / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
bleeding / Early / Incidence not known
leukopenia / Delayed / Incidence not known
hematoma / Early / Incidence not known
hypertension / Early / Incidence not known
peripheral vasodilation / Rapid / Incidence not known
chest pain (unspecified) / Early / Incidence not known
phlebitis / Rapid / Incidence not known
QT prolongation / Rapid / Incidence not known
hypotension / Rapid / Incidence not known
orthostatic hypotension / Delayed / Incidence not known
sinus tachycardia / Rapid / Incidence not known
palpitations / Early / Incidence not known
edema / Delayed / Incidence not known
dyspnea / Early / Incidence not known
blurred vision / Early / Incidence not known
hyperbilirubinemia / Delayed / Incidence not known
hepatitis / Delayed / Incidence not known
elevated hepatic enzymes / Delayed / Incidence not known
hyperprolactinemia / Delayed / Incidence not known
priapism / Early / Incidence not known
urinary retention / Early / Incidence not known
dysuria / Early / Incidence not known
myasthenia / Delayed / Incidence not known
hyperglycemia / Delayed / Incidence not known
diabetes mellitus / Delayed / Incidence not known
hypoglycemia / Early / Incidence not known
hypokalemia / Delayed / Incidence not known
hypercholesterolemia / Delayed / Incidence not known
osteopenia / Delayed / Incidence not known
withdrawal / Early / Incidence not known
growth inhibition / Delayed / Incidence not known
Mild
flatulence / Early / Incidence not known
weight loss / Delayed / Incidence not known
pyrosis (heartburn) / Early / Incidence not known
gastroesophageal reflux / Delayed / Incidence not known
hypoesthesia / Delayed / Incidence not known
asthenia / Delayed / Incidence not known
nightmares / Early / Incidence not known
tremor / Early / Incidence not known
vertigo / Early / Incidence not known
restless legs syndrome (RLS) / Delayed / Incidence not known
agitation / Early / Incidence not known
emotional lability / Early / Incidence not known
anxiety / Delayed / Incidence not known
paranoia / Early / Incidence not known
restlessness / Early / Incidence not known
irritability / Delayed / Incidence not known
purpura / Delayed / Incidence not known
epistaxis / Delayed / Incidence not known
ecchymosis / Delayed / Incidence not known
syncope / Early / Incidence not known
malaise / Early / Incidence not known
fever / Early / Incidence not known
urticaria / Rapid / Incidence not known
flushing / Rapid / Incidence not known
photosensitivity / Delayed / Incidence not known
rash (unspecified) / Early / Incidence not known
alopecia / Delayed / Incidence not known
cough / Delayed / Incidence not known
nasal congestion / Early / Incidence not known
diplopia / Early / Incidence not known
mydriasis / Early / Incidence not known
tinnitus / Delayed / Incidence not known
dysmenorrhea / Delayed / Incidence not known
menorrhagia / Delayed / Incidence not known
increased urinary frequency / Early / Incidence not known
muscle cramps / Delayed / Incidence not known
arthralgia / Delayed / Incidence not known
myalgia / Early / Incidence not known
back pain / Delayed / Incidence not known
DRUG INTERACTIONS
Abciximab: (Moderate) Platelet aggregation may be impaired by selective serotonin reuptake inhibitors (SSRIs) due to platelet serotonin depletion, possibly increasing the risk of a bleeding complication in patients receiving abciximab. Monitor closely for signs and symptoms of bleeding.
Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) The combined use of selective serotonin reuptake inhibitors and aspirin, ASA may elevate the risk for an upper GI bleed. SSRIs may inhibit serotonin uptake by platelets, augmenting the antiplatelet effects of aspirin. Additionally, aspirin impairs the gastric mucosa defenses by inhibiting prostaglandin formation.
Acetaminophen; Butalbital: (Moderate) Escitalopram is metabolized by CYP2C19 and CYP3A4. Barbiturates can induce the metabolism of various CYP 450 isoenzymes, including those involved in escitalopram metabolism. Although no clinical data are available to support a clinically significant interaction, escitalopram may need to be administered in higher doses in patients chronically taking barbiturates.
Acetaminophen; Butalbital; Caffeine: (Moderate) Escitalopram is metabolized by CYP2C19 and CYP3A4. Barbiturates can induce the metabolism of various CYP 450 isoenzymes, including those involved in escitalopram metabolism. Although no clinical data are available to support a clinically significant interaction, escitalopram may need to be administered in higher doses in patients chronically taking barbiturates.
Acetaminophen; Butalbital; Caffeine; Codeine: (Moderate) Escitalopram is metabolized by CYP2C19 and CYP3A4. Barbiturates can induce the metabolism of various CYP 450 isoenzymes, including those involved in escitalopram metabolism. Although