Escitalopram Oral
Generic Name: escitalopram oral
Brand Names:
Escitalopram Oral Solution
11 DESCRIPTION Escitalopram Oral Solution, USP contains escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.
Overview
11 DESCRIPTION Escitalopram Oral Solution, USP contains escitalopram oxalate, an orally administered selective serotonin reuptake inhibitor (SSRI), present as escitalopram oxalate salt. Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.
Uses
1 INDICATIONS AND USAGE Escitalopram is 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 and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Indication and Population Recommended Dosage MDD in Adults ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily MDD in Pediatric Patients 12 years and older ( 2.1 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily GAD in Adults ( 2.2 ) Initial: 10 mg once daily Recommended: 10 mg once daily Maximum: 20 mg once daily No additional benefits were seen at 20 mg once daily ( 2.1 ) Administer once daily, morning or evening, with or without food ( 2.3 ) Elderly patients: recommended dosage is 10 mg once daily ( 2.4 ) Hepatic impairment: recommended dosage is 10 mg once daily ( 2.4 , 8.6 ) When discontinuing escitalopram, reduce dose gradually whenever possible ( 2.5 ) 2.1 Major Depressive Disorder Ad...
Side Effects
6 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 Precaut...
Interactions
7 DRUG INTERACTIONS Table 6 presents clinically important drug interactions with escitalopram. TABLE 6 Clinically Important Drug Interactions with Escitalopram Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: Concomitant use of SSRIs, including escitalopram, and MAOIs increases the risk of serotonin syndrome. Intervention: Escitalopram 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) ].
Warnings
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 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 is not approved for use in pediatric patients less than 7 years of age [ see Use in Specific Populations (8.4) ] . 5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3 ) Seizures: Use with caution in patients with a history of seizure ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6 ) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other dr... 4 CONTRAINDICATIONS Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Escitalopram Oral Solution, USP, 5 mg/5 mL, a clear, colorless liquid with peppermint flavor Unit Dose Cup of 10 mL NDC # 68999-729-10 20 Unit Dose Cups of 10 mL NDC # 68999-729-24 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Escitalopram Oral used for?▼
1 INDICATIONS AND USAGE Escitalopram is 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 and LEXAPRO (escitalopram) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )
What are the side effects of Escitalopram Oral?▼
6 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 Precaut...
What are the important warnings for Escitalopram Oral?▼
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS 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 is not approved for use in pediatric patients less than 7 years of age [ see Use in Specific Populations (8.4) ] . 5 WARNINGS AND PRECAUTIONS Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents but also when taken alone. If it occurs, discontinue escitalopram and serotonergic agents and initiate supportive treatment ( 4 , 5.2 ) Discontinuation syndrome: When discontinuing escitalopram, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms ( 5.3 ) Seizures: Use with caution in patients with a history of seizure ( 5.4 ) Activation of Mania/Hypomania: Screen patients for bipolar disorder ( 5.5 ) Hyponatremia: Can occur in association with syndrome of inappropriate antidiuretic hormone secretion ( 5.6 ) Increased Risk of Bleeding: Concomitant use of nonsteroidal anti-inflammatory drugs, aspirin, other antiplatelet drugs, warfarin and other dr... 4 CONTRAINDICATIONS Escitalopram is contraindicated in patients: taking MAOIs with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.