ESCITALOPRAM OXALATE 5 mg/1
escitalopram · TABLET · Ascent Pharmaceuticals, Inc
Escitalopram is a prescription medication taken by mouth used to treat depression and anxiety disorders. It belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
Key Facts
- Brand Name
- ESCITALOPRAM OXALATE
- Generic Name
- escitalopram
- NDC Code (Product)
43602-473- Manufacturer
- Ascent Pharmaceuticals, Inc
- Strength
- 5 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA215177
- Marketing Start
- 07/15/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Escitalopram oral solution 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) oral solution. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram oral solution 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 & Administration
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 oral solution, reduce dose gradually whenever possible. (2.5) 2.1 Major Depressive Disorder Adults The recommended dosage of escitalopram oral solution in adults is 10 mg once daily. A fixed-dose trial of escitalopram oral solution demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram oral solution, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1) ] . Depending on clinical response and tolerability, dosage may be increased to…
Contraindications
4 CONTRAINDICATIONS Escitalopram oxalate is contraindicated in patients: taking MAOIs with escitalopram oxalate or within 14 days of stopping treatment with escitalopram oxalate because of an increased risk of serotonin syndrome. The use of escitalopram oxalate 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 oxalate 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 oral solution. Do not use MAOIs intended to treat psychiatric disorders with escitalopram oxalate or within 14 days of stopping treatment with escitalopram oxalate. Do not use escitalopram oxalate within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start escitalopram oxalate in a patient who …
Drug Interactions
7 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, opioi…
Adverse Reactions
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 Precautions (5.10) ] Sexual Dysfunction [see Warnings and Precautions (5.11) ] Most commonly observed adverse reactions (incidence ≥ 5% and at least twice the incidence of placebo patients) are: insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue and somnolence, decreased libido, and anorgasmia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceutical…
Frequently Asked Questions
What is ESCITALOPRAM OXALATE used for?
Escitalopram is a prescription medication taken by mouth used to treat depression and anxiety disorders. It belongs to a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
Is ESCITALOPRAM OXALATE a controlled substance?
ESCITALOPRAM OXALATE is not classified as a controlled substance by the DEA.
What is the generic name for ESCITALOPRAM OXALATE?
The generic name for ESCITALOPRAM OXALATE is escitalopram. There are 11 other brand versions of escitalopram.
What is the NDC code for ESCITALOPRAM OXALATE 5 mg/1?
The NDC (National Drug Code) for ESCITALOPRAM OXALATE 5 mg/1 is 43602-473, listed by Ascent Pharmaceuticals, Inc.
Other ESCITALOPRAM OXALATE Dosages
Other Escitalopram Brands
See all →- Lexapro5 mg/10456-2005
- escitalopram10 mg/172162-2241
- Escitalopram Oxalate5 mg/172603-149
- Escitalopram oxalate20 mg/176282-251
- escitalopram20 mg/10904-6427
- Escitalopram Oxalate5 mg/5mL16571-769
- Escitalopram10 mg/116729-169
- Escitalopram20 mg/143063-661
- Escitalopram Oxalate10 mg/153746-020
- Escitalopram20 mg/168071-5248
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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