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Lexapro

Generic Name: Escitalopram Oxalate
Drug Category: SSRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 12 years old for a maximum duration of 8 weeks.

Approved Uses

Indicated for:

Major Depressive Disorder:

• For the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age.

Generalized Anxiety Disorder:

• For the acute treatment of Generalized Anxiety Disorder (GAD) in adults.

It should be noted that Lexapro is not approved for use in treating bipolar depression.

A major depressive episode may be the initial presentation of bipolar disorder. 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.

Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, Lexapro should be used cautiously in patients with a history of mania.

10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

Antidepressants increased the risk compared to 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 Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.

The use of MAOIs intended to treat psychiatric disorders with Lexapro or within 14 days of stopping treatment with Lexapro is contraindicated because of an increased risk of serotonin syndrome. The use of Lexapro within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting Lexapro in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

Concomitant use in patients taking pimozide is contraindicated.

No additional benefits seen at 20 mg/day dose.10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

SSRIs and SNRIs, including Lexapro, may increase the risk of bleeding events.

Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.

The pupillary dilation that occurs following use of many antidepressant drugs including Lexapro may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Although anticonvulsant effects of racemic citalopram have been observed in animal studies, Lexapro has not been systematically evaluated in patients with a seizure disorder.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Lexapro. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), and was reversible when Lexapro was discontinued.

Clinical experience with Lexapro in patients with certain concomitant systemic illnesses is limited. Caution is advisable in using Lexapro in patients with diseases or conditions that produce altered metabolism or hemodynamic responses.

Serotonin syndrome has been reported with SSRIs and SNRIs, including Lexapro, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Patients should be cautioned about the risk of bleeding associated with the concomitant use of Lexapro and NSAIDs, aspirin, or other drugs that affect coagulation.

Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when Lexapro is initiated or discontinued.

There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of Lexapro with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Given the primary CNS effects of escitalopram, caution should be used when it is taken in combination with other centrally acting drugs.

Although Lexapro did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by patients taking Lexapro is not recommended.

In subjects who had received 21 days of 40 mg/day racemic citalopram, combined administration of 400 mg twice a day cimetidine for 8 days resulted in an increase in citalopram AUC and Cmax of 43% and 39%, respectively.

Because lithium may enhance the serotonergic effects of escitalopram, caution should be exercised when Lexapro and lithium are co-administered.

There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of an SSRI and sumatriptan.

Carbamazepine might increase the clearance of escitalopram should be considered if the two drugs are co-administered.

Caution is indicated in the co-administration of escitalopram and drugs metabolized by CYP2D6.

Administration of 20 mg/day Lexapro for 21 days in healthy volunteers resulted in a 50% increase in Cmax and 82% increase in AUC of the beta-adrenergic blocker metoprolol (given in a single dose of 100 mg). Increased metoprolol plasma levels have been associated with decreased cardioselectivity.

There are no adequate and well-controlled studies in pregnant women. Neonates exposed to Lexapro and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings 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 a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.

Escitalopram is excreted in human breast milk.

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Off-label Uses

• Premature ejaculation, migraine headaches, diabetic neuropathy, fibromyalgia and neurocardiogenic syncope. GoToSource   

• Alcoholism. GoToSource

• Autism. GoToSource

• Alzheimer’s disease, dementia or vascular dementia. GoToSource

• Eating disorders. GoToSource

• Hot flashes. GoToSource

• Tourette syndrome. GoToSource

• Narcolepsy. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Pathological skin picking. GoToSource

• Pervasive developmental disorders. GoToSource

• Body dysmorphic disorder. GoToSource

• Post-traumatic stress disorder. GoToSource 

• Pathological gambling. GoToSource

• Social anxiety disorder. GoToSource

• Panic disorder. GoToSource

• Agoraphobia. GoToSource

• Premenstrual dysphoric disorder. GoToSource

• Bipolar depression. GoToSource

• Raynaud’s syndrome. GoToSource

• Trichotillomania (hair-pulling). GoToSource 

• Prevention of chronic postoperative pain. GoToSource 

• Charles bonnet syndrome. GoToSource  

• Fatigue in multiple sclerosis. GoToSource  

• Night eating syndrome. GoToSource  

• Sleep disorders. GoToSource 

• Prevention of psychiatric side-effects during interferon-based treatment of hepatitis C. GoToSource 

• Chronic low back pain. GoToSource

Adverse Events

Birth defects. GoToSource

Significant decrease in sperm concentration, motility and morphology. GoToSource

Suicidal thoughts and behavior. GoToSource

Prolonged QT interval, sudden cardiac death and torsade de pointes. GoToSource

Weight gain and significant increases in triglyceride levels. GoToSource 

Hyponatremia (low blood sodium). GoToSource 

SSRI use is associated with doubled the odds of upper gastrointestinal bleeding and increased risk of bleeding with surgical procedures. GoToSource

Serotonin syndrome (life-threatening drug reaction). GoToSource

Deep vein thrombosis. GoToSource

Angle-closure glaucoma. GoToSource

Akathisia (movement disorder). GoToSource 

Hyperglycemia (high blood sugar). GoToSource 

Liver toxicity. GoToSource 

Drug-induced parkinsonism. GoToSource

Acute urinary retention. GoToSource 

Galactorrhea (milky discharge). GoToSource 

Drug-induced restless legs syndrome. GoToSource 

Decreased platelet count. GoToSource 

Word finding difficulty. GoToSource 

Subclinical hypothyroidism. GoToSource 

Gastroesophageal reflux disease. GoToSource 

Extrapyramidal symptoms. GoToSource 

Hypomania (mild form of mania). GoToSource  

Discontinuation syndrome (condition following the interruption, dose reduction, or discontinuation of antidepressant drugs, common symptoms include flu-like symptoms, insomnia, nausea, imbalance and sensory disturbances). GoToSource   

Seizures. GoToSource 

Bilateral peripheral edema (excessive fluid in the tissues). GoToSource

Litigation

Lawsuits filed for birth defects and suicide. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated March 28, 2024