Escitalopram Oxalate (3 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, SOLUTION, CAPSULE.
Routes of administration: ORAL.
Brand Names
- ESCITALOPRAM
- ESCITALOPRAM OXALATE
- LEXAPRO
Boxed Warning
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Escitalopram oxalate is not approved for use in pediatric patients less than 7 years of age [see Use in Specific Populations (8.4)].
Indications and Usage
Escitalopram tablets are indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.’s LEXAPRO (escitalopram) tablets. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.
Contraindications
Escitalopram tablets is contraindicated in patients: taking MAOIs with escitalopram tablets or within 14 days of stopping treatment with escitalopram tablets because of an increased risk of serotonin syndrome. The use of escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.7) and Warnings and Precautions (5.2)]. Starting escitalopram tablets 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 [see Dosage and Administration (2.6) and Warnings and Precautions (5.2)]. taking pimozide [see Drug Interactions (7)]. with a hypersensitivity to escitalopram or citalopram or any of the inactive ingredients in escitalopram tablets.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the labeling: Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.1)] Serotonin syndrome [see Warnings and Precautions (5.2)] Discontinuation syndrome [see Warnings and Precautions (5.3)] Seizures [see Warnings and Precautions (5.4)] Activation of mania or hypomania [see Warnings and Precautions (5.5)] Hyponatremia [see Warnings and Precautions (5.6)] Increased Risk of Bleeding [see Warnings and Precautions (5.7)] Interference with Cognitive and Motor Performance [see Warnings and Precautions (5.8)] Angle-closure glaucoma [see Warnings and Precautions (5.9)] Use in Patients with Concomitant Illness [see Warnings and Precautions (5.10)] Sexual Dysfunction [see Warnings and Precautions (5.11)]
Drug Interactions
Table 6 presents clinically important drug interactions with escitalopram oxalate. TABLE 6 Clinically Important Drug Interactions with Escitalopram Oxalate Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including escitalopram oxalate, and MAOIs increases the risk of serotonin syndrome. Intervention: Escitalopram oxalate is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.7), Contraindications (4), and Warnings and Precautions (5.2)]. Pimozide Clinical Impact: Concomitant use of racemic citalopram with pimozide increases plasma concentrations of pimozide, a drug with a narrow therapeutic index, and may increase the risk of QT prolongation and/or ventricular arrhythmias compared to use of racemic citalopram alone [see Clinical Pharmacology (12.3)]. Intervention: Escitalopram oxalate is contraindicated in patients taking pimozide [see Contraindications (4)]. Other Serotonergic Drugs Clinical Impact: Concomitant use of escitalopram oxalate and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John’s Wort) increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during escitalopram oxalate initiation and dosage increases. If serotonin syndrome occurs, consider discontinuation of escitalopram oxalate and/or concomitant serotonergic drugs [see Warning and Precautions (5.2)]. Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.) Clinical Impact: Concomitant use of escitalopram oxalate and an antiplatelet or anticoagulant may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding associated with the concomitant use of escitalopram oxalate and antiplatelet agents and anticoagulants. For patients taking warfarin, carefu
Mechanism of Action
The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system (CNS) resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).
Overdosage
The following have been reported with escitalopram tablet overdosage: Seizures, which may be delayed, and altered mental status including coma. Cardiovascular toxicity, which may be delayed, including QRS and QTc interval prolongation, wide complex tachyarrhythmias, and torsade de pointes. Hypertension most commonly seen, but rarely can see hypotension alone or with co-ingestants including alcohol. Serotonin syndrome (patients with a multiple drug overdosage with other proserotonergic drugs may have a higher risk). Prolonged cardiac monitoring is recommended in escitalopram oxalate overdosage ingestions due to the arrhythmia risk. Gastrointestinal decontamination with activated charcoal should be considered in patients who present early after a escitalopram oxalate overdose. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.