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Lexapro (Escitalopram Oxalate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Major Depressive Disorder

Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see Clinical Studies (14.1)].

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

Generalized Anxiety Disorder

Lexapro is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [see Clinical Studies (14.2)].

Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.

DOSAGE AND ADMINISTRATION

Lexapro should be administered once daily, in the morning or evening, with or without food.

Major Depressive Disorder

Initial Treatment

Adolescents

The recommended dose of Lexapro is 10 mg once daily. A flexible-dose trial of Lexapro (10 to 20 mg/day) demonstrated the effectiveness of Lexapro [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.

Adults

The recommended dose of Lexapro is 10 mg once daily. A fixed-dose trial of Lexapro demonstrated the effectiveness of both 10 mg and 20 mg of Lexapro, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Maintenance Treatment

It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing Lexapro 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking Lexapro during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies ]. Nevertheless, the physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.

Generalized Anxiety Disorder

Initial Treatment

Adults

The recommended starting dose of Lexapro is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Maintenance Treatment

Generalized anxiety disorder is recognized as a chronic condition. The efficacy of Lexapro in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use Lexapro for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Special Populations

10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Lexapro should be used with caution in patients with severe renal impairment.

Discontinuation of Treatment with Lexapro

Symptoms associated with discontinuation of Lexapro and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Switching Patients To or From a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of an MAOI and initiation of Lexapro therapy. Similarly, at least 14 days should be allowed after stopping Lexapro before starting an MAOI [see Contraindications and Warnings and Precautions (5.10)].

DOSAGE FORMS AND STRENGTHS

Tablets

Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. Imprinted with "FL" on one side and either "5", “10”, or “20” on the other side according to their respective strengths.

Oral Solution

Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base.

HOW SUPPLIED/STORAGE AND HANDLING

Tablets

5 mg Tablets:
Bottle of 100                     NDC # 0456-2005-01

White to off-white, round, non-scored, film-coated. Imprint "FL" on one side of the tablet and "5" on the other side.

10 mg Tablets:
Bottle of 100                     NDC # 0456-2010-01
10 x 10 Unit Dose           NDC # 0456-2010-63

White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "10".

20 mg Tablets:
Bottle of 100                     NDC # 0456-2020-01
10 x 10 Unit Dose           NDC # 0456-2020-63

White to off-white, round, scored, film-coated. Imprint on scored side with "F" on the left side and "L" on the right side. Imprint on the non-scored side with "20".

Oral Solution

5 mg/5 mL, peppermint flavor (240 mL) NDC # 0456-2101-08

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59-86°F).

PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide

Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe Lexapro.

General Information about Medication Guide

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Lexapro and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Lexapro. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Lexapro.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.1)].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Lexapro and triptans, tramadol or other serotonergic agents [see Warnings and Precautions (5.2)].

Abnormal Bleeding

Patients should be cautioned about the concomitant use of Lexapro and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.7)].

Concomitant Medications

Since escitalopram is the active isomer of racemic citalopram (Celexa), the two agents should not be coadministered. Patients should be advised to inform their physician if they are taking, or plan to take, any prescription or over-the-counter drugs, as there is a potential for interactions.

Continuing the Therapy Prescribed

While patients may notice improvement with Lexapro therapy in 1 to 4 weeks, they should be advised to continue therapy as directed.

Interference with Psychomotor Performance

Because psychoactive drugs may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that Lexapro therapy does not affect their ability to engage in such activities.

Alcohol

Patients should be told that, although Lexapro has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of Lexapro and alcohol in depressed patients is not advised.

Pregnancy and Breast Feeding

Patients should be advised to notify their physician if they

  • become pregnant or intend to become pregnant during therapy.
  • are breastfeeding an infant.

Need for Comprehensive Treatment Program

Lexapro is indicated as an integral part of a total treatment program for MDD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all adolescents with this syndrome. Safety and effectiveness of Lexapro in MDD has not been established in pediatrics patients less than 12 years of age. Antidepressants are not intended for use in the adolescent who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe antidepressant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

FDA-Approved Medication Guide

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