RECENT MAJOR CHANGES

Indication and Usage, Major Depressive Disorder (1.1) 03/2009

Dosage and Administration, Major Depressive Disorder (2.1) 03/2009

Warnings and Precautions, Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions (5.2) 01/2009

Warnings and Precaution, Hyponatremia (5.6) 03/2008

Warnings and Precautions, Abnormal Bleeding (5.7) 03/2008

INDICATIONS AND USAGE

Lexapro® is a selective serotonin reuptake inhibitor (SSRI) indicated for:

• Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12-17 years (1.1)
• Acute Treatment of Generalized Anxiety Disorder (GAD) in adults (1.2)

DOSAGE AND ADMINISTRATION

Lexapro should generally be administered once daily, morning or evening with or without food (2.1, 2.2).

• No additional benefits seen at 20 mg/day dose (2.1).
• 10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment (2.3).
• No dosage adjustment for patients with mild or moderate renal impairment. Use caution in patients with severe renal impairment (2.3).
• Discontinuing Lexapro: A gradual dose reduction is recommended (2.4).

DOSAGE FORMS AND STRENGTHS

• Tablets: 5 mg, 10 mg (scored) and 20 mg (scored) (3.1)
• Oral solution: 1 mg per mL (3.2)

CONTRAINDICATIONS

• Monoamine Oxidase Inhibitors: Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 14 days after stopping Lexapro before starting an MAOI (4.1, 5.10).
• Pimozide: Do not use concomitantly (4.2, 7.10).
• Known hypersensitivity to escitalopram or citalopram or any of the inactive ingredients (4.3).

WARNINGS AND PRECAUTIONS

• Clinical Worsening/Suicide Risk: Monitor for clinical worsening, suicidality and unusual change in behavior, especially, during the initial few months of therapy or at times of dose changes (5.1).
• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions: Manage with immediate discontinuation and continuing monitoring (5.2).
• Discontinuation of Treatment with Lexapro: A gradual reduction in dose rather than abrupt cessation is recommended whenever possible (5.3).
• Seizures: Prescribe with care in patients with a history of seizure (5.4).
• Activation of Mania/Hypomania: Use cautiously in patients with a history of mania (5.5).
• Hyponatremia: Can occur in association with SIADH (5.6).
• Abnormal Bleeding: Use caution in concomitant use with NSAIDs, aspirin, warfarin or other drugs that affect coagulation (5.7).
• Interference with Cognitive and Motor Performance: Use caution when operating machinery (5.8).
• Use in Patients with Concomitant Illness: Use caution in patients with diseases or conditions that produce altered metabolism or hemodynamic responses (5.9).

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 1-800-FDA-1088, or 1-800-822-7967

DRUG INTERACTIONS

Concomitant use with SSRIs, SNRIs or Tryptophan is not recommended (7.1).

Use caution when concomitant use with drugs that affect Hemostasis (NSAIDs, Aspiring, Warfarin) (7.6).

USE IN SPECIFIC POPULATIONS

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus (8.1).

Nursing Mothers: Caution should be exercised when administered to a nursing woman (8.3)

Pediatric Use: Safety and effectiveness of Lexapro has not been established in pediatric MDD patients less than 12 years of age (8.4).