Escitalopram 5 mg Tablets — Generic For Lexapro — Rising Pharma

These highlights do not include all the information needed to use ESCITALOPRAM TABLETS safely and effectively. See full prescribing information for ESCITALOPRAM TABLETS.

ESCITALOPRAM tablets, for oral use

Initial U.S. Approval: 2002

Warning: Suicidal Thoughts And Behaviors

See full prescribing information for complete boxed warning.

Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). Escitalopram tablets is not approved for use in pediatric patients less than 7 years of age (8.4).

Recent Major Changes

Indications (1) 5/2023

Dosage and Administration (2.2, 2.3, 2.5) 5/2023

Dosage and Administration, Use of Escitalopram tablets with Other MAOIs

such as Linezolid or Methylene Blue (2.7) – Removed 5/2023

Warnings and Precautions (5.2, 5.7) 5/2023

Indications And Usage

Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for:

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 And Administration

Indication and Population

Recommended Dose

MDD in Adolescents (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 tablets, reduce dose gradually whenever possible (2.5)

Dosage Forms And Strengths

Tablets: 5 mg, 10 mg (scored) and 20 mg (scored)

Contraindications

Do not use MAOIs intended to treat psychiatric disorders with Escitalopram tablets or within 14 days of stopping treatment with Escitalopram tablets. Do not use Escitalopram tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start Escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue (4)

Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4)

Warnings And Precautions

• (5.2, 5.7) 5/2023 INDICATIONS AND USAGE Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for:
• 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 AND ADMINISTRATION Indication and Population Recommended Dose MDD in Adolescents (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 tablets, reduce dose gradually whenever possible (2.5) DOSAGE FORMS AND STRENGTHS

• (5.2, 5.7) 5/2023 INDICATIONS AND USAGE Escitalopram tablets are a selective serotonin reuptake inhibitor (SSRI) indicated for:
• 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 AND ADMINISTRATION Indication and Population Recommended Dose MDD in Adolescents (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 tablets, reduce dose gradually whenever possible (2.5) DOSAGE FORMS AND STRENGTHS

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue Escitalopram tablets and initiate supportive treatment (4, 5.2)

Discontinuation syndrome: When discontinuing Escitalopram tablets, reduce dosage gradually whenever possible, and monitor for discontinuation symptoms (5.3)

Seizures: Use with care 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 drugs that affect coagulation may increase risk (5.7).

Interference with Cognitive and Motor Performance: Use caution when operating machinery (5.8).

Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. (5.9)

Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses (5.10).

Sexual Dysfunction: Escitalopram tablets may cause symptoms of sexual dysfunction (5.11).

Adverse Reactions

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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended (7).

Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspirin, Warfarin) (7).

Use In Specific Populations

● Pregnancy: SSRI use, particularly later in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate. (8.1).

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.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 8/2024