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What is Lexapro?
Lexapro Side Effects
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Lexapro Clinical Pharmacology
How to Take Lexapro
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Types of Depression
Lexapro Administration
Lexapro Storage
Lexapro Warnings
Lexapro Precautions
Lexapro Information for Patients

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Primary Disease Name: Depression
Primary Drug Name: Lexapro
Chemical Drug Name: escitalopram oxalate

What is Lexapro?

Lexapro is an antidepressant that is the newest member of the family of medications known as selective serotonin reuptake inhibitors (SSRIs). LEXAPRO was developed by isolating a part of the CELEXATM (citalopram HBr) molecule, known as an isomer. As a result, LEXAPRO is able to provide effective and well-tolerated therapy for depressed patients.

For many patients, relief from symptoms such as depressed mood or anxiety symptoms associated with depression may begin after taking LEXAPRO for 1 or 2 weeks, but most people can expect to feel the full benefits of LEXAPRO in 4 to 6 weeks.

For the greatest benefit, LEXAPRO should always be taken exactly as prescribed by a healthcare professional or doctor. It is important to continue taking LEXAPRO even after relief from depression begins. People don't suddenly become depressed, and full recovery takes time. Healthcare professionals or doctors may recommend continued LEXAPRO treatment even if symptoms are improving or resolved, to help keep the depression from coming back.

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Lexapro Side Effects

LEXAPRO is well tolerated by most people. The most frequent lexapro side effects reported with LEXAPRO are nausea, insomnia, problems with ejaculation, drowsiness, increased sweating, and fatigue. Most of the Lexapro side effects experienced by patients taking LEXAPRO are mild and transient, and they usually do not cause patients to stop taking LEXAPRO.

People taking LEXAPRO generally do not suffer from agitation, nervousness, or anxiety any morthan people not taking LEXAPRO. Furthermore, patients who were treated with LEXAPRO experienced no clinically important weight changes as a result of therapy. Patients should be sure to talk with their healthcare professional or doctor promptly if they have any side effects when taking LEXAPROT (escitalopram oxalate). A simple adjustment in dose may be all that is required.

Other Lexapro Side Effects
The following Lexapro side effects have been established in clinical trials:

Autonomic Nervous System Disorders
dry mouth
increased sweating

Central & Peripheral Nervous System Disorders
diziness

Gastrointestinal Disorders

nausea
diarrhea
constipation
indigestion
abdominal pain
general
influenza-like symptoms
fatigue
psychiatric disorders
insomnia
somnolence
appetite decreased
libido decreased

Respiratory System Disorders
rhinitis
sinusitis

Urogenital
ejaculation Disorder
impotence
anorgasmia

Lexapro Side Effects Associated with Discontinuation of Treatment:

Among the 715 depressed patients who received Lexapro in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed dose studies, the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo. The rate of discontinuation for adverse events in patients assigned to a fixed dose of 20 mg/day Lexapro was 10% which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice the placebo rate, were nausea (2%) and ejaculation disorder (2% of male patients).

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Lexapro Mechanism of Action

Lexapro is an antidepressant from the family of drugs known as selective serotonin reuptake inhibitors or SSRIs. Lexapro helps to restore the brain's chemical balance by increasing the supply of a substance in the brain called serotonin. Lexapro appears to relieve depression by increasing serotonin without affecting many of the other chemicals in the brain that influence mood. Physicians are advised to discuss the following issues with patients for whom they prescribe LEXAPRO.

In a study in normal volunteers, LEXAPRO 10 mg/day did not impair psychomotor performance. The effect of LEXAPRO on psychomotor coordination, judgment, or thinking has not been systematically examined in controlled studies. 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.
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.

Patients should be made aware that escitalopram is the active isomer of Celexa (citalopram hydrobromide) and that the two medications should not be taken concomitantly.

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.

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Lexapro Clinical Pharmacology

The mechanism of antidepressant action of escitalopram, the S-enantiomer of racemic citalopram, is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT). In vitro and in vivo studies in animals suggest that escitalopram is a highly selective serotonin reuptake inhibitor (SSRI) with minimal effects on norepinephrine and dopamine neuronal reuptake. Escitalopram is at least 100 fold more potent than the R-enantiomer with respect to inhibition of 5-HT reuptake and inhibition of 5-HT neuronal firing rate. Tolerance to a model of antidepressant effect in rats was not induced by long-term (up to 5 weeks) treatment with escitalopram. Escitalopram has no or very low affinity for serotonergic (5-HT1-7) or other receptors including alpha- and beta-adrenergic, dopamine (D1-5), histamine (H1-3), muscarinic (M1-5), and benzodiazepine receptors. Escitalopram also does not bind to or has low affinity for various ion channels including Na+, K+, Cl- and Ca++ channels. Antagonism of muscarinic, histaminergic and adrenergic receptors has been hypothesized to be associated with various anticholinergic, sedative and cardiovascular side effects of other psychotropic drugs.

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How to Take Lexapro

LEXAPRO is easy to take. It should be taken once a day with a full glass (8 ounces) of water, at any time of day, with or without food. For best results, LEXAPRO should be taken every day-and prescriptions should be filled ahead oftime to avoid missing a dose.

LEXAPRO can be taken with most other medications. An exception is another family of antidepressants called monoamine oxidase inhibitors (MAOIs),* such as Nardil® (phenelzine sulfate tablets, USP)? and Parnate® (tranylcypromine sulfate).? LEXAPRO and MAOIs should not be taken together or within 14 days of each other. Before taking LEXAPRO, it is important for patients to tell their healthcare professional or doctor if they are taking any other medications, including over-the-counter medications, herbal remedies, diet supplements, etc.

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Lexapro Dose / Supply

LEXAPRO is available in two doses. LEXAPRO comes as a 10mg tablet, and 20mg tablet

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Types of Depression

Depressive disorders come in different forms. There are several different diagnoses for depression, mostly determined by the intensity of the symptoms, the duration of the symptoms, and the specific cause of the symptoms, if that is known.

Psychology Information Online provides information on the following depressive disorders. Follow the title link for more information about each type of depression:

1. Major Depression - This is the most serious type of depression, in terms of number of symptoms and severity of symptoms, but there are significant individual differences in the symptoms and severity. You do not need to feel suicidal to have a major depression, and you do not need to have a history of hospitalizations either, although both of these factors are present in some people with major depression. There is no official diagnosis of "moderate depression."

2. Dysthymic Disorder - This refers to a low to moderate level of depression that persists for at least two years, and often longer. While the symptoms are not as severe as a major depression, they are more enduring and resistant to treatment. Some people with dysthymia develop a major depression at some time during the course of their depression.

3. Unspecified Depression - This category is used to help researchers who are studying other specific types of depression, and do not want their data confounded with marginal diagnoses. It includes people with a serious depression, but not quite severe enough to have a diagnosis of a major depression. It also includes people with chronic, moderate depression, which has not been present long enough for a diagnosis of a Dysthymic disorder. (You get the idea!)

4. Adjustment Disorder, with Depression - This category describes depression that occurs in response to a major life stressor or crisis.

5. Bipolar Depression - This type includes both high and low mood swings, as well as a variety of other significant symptoms not present in other depressions.

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Lexapro Dosage and Administration

Major Depressive Disorder Initial Treatment
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 Efficacy Trials under Clinical Pharmacology). If the dose is increased to 20 mg, this should occur after a minimum of one week.

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

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.

Treatment of Pregnant Women During the Third Trimester
Neonates exposed to LEXAPRO and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with LEXAPRO during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering LEXAPRO in the third trimester.

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 for periods of up to 36 weeks in 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 Efficacy Trials, under Clinical Pharmacology). Nevertheless, patients should be periodically reassessed to determine the need for maintenance treatment.

Generalized Anxiety Disorder
Initial Treatment

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

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 reevaluate the long term usefulness of the drug for the individual patient.

Discontinuation of Treatment with LEXAPRO
Symptoms associated with discontinuation of LEXAPRO and other SSRIs and SNRIs, have been reported (see PRECAUTIONS). 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 a MAOI and initiation of LEXAPRO therapy. Similarly, at least 14 days should be allowed after stopping LEXAPRO before starting a MAOI (see Contraindications and Warnings).

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Lexapro Storage

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

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Lexapro Warnings


Potential for Interaction with Monoamine Oxidase Inhibitors

In patients receiving serotonin reuptake inhibitor drugs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on a MAOI. Some cases presented with features resembling neuroleptic malignant syndrome.

Furthermore, limited animal data on the effects of combined use of SSRIs and MAOIs suggest that these drugs may act synergistically to elevate blood pressure and evoke behavioral excitation. Therefore, it is recommended that LEXAPRO should not be used in combination with a MAOI, or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should be allowed after stopping LEXAPRO before starting a MAOI.

Serotonin syndrome has been reported in two patients who were concomitantly receiving linezolid an antibiotic which is a reversible non-selective MAOI.

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Lexapro Precautions

General

Discontinuation of Treatment with LEXAPRO
During marketing of Lexapro and other SSRIs and SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.

Patients should be monitored for these symptoms when discontinuing treatment with LEXAPRO. 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

Abnormal Bleeding
Published case reports have documented the occurrence of bleeding episodes in patients treated with psychotropic drugs that interfere with serotonin reuptake. Subsequent epidemiological studies, both of the case-control and cohort design, have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding. In two studies, concurrent use of a nonsteroidal anti-inflammatory drug (NSAID) or aspirin potentiated the risk of bleeding. Although these studies focused on upper gastrointestinal bleeding, there is reason to believe that bleeding at other sites may be similarly potentiated. Patients should be cautioned regarding the risk of bleeding associated with the concomitant use of LEXAPRO with NSAIDS, aspirin, or other drugs that affect coagulation.

Hyponatremia
One case of hyponatremia has been reported in association with LEXAPRO treatment. Several cases of hyponatremia or SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported in association with racemic citalopram. All patients with these events have recovered with discontinuation of escitalopram or citalopram and/or medical intervention. Hyponatremia and SIADH have also been reported in association with other marketed drugs effective in the treatment of major depressive disorder.

Activation of Mania/Hypomania
In placebo-controlled trials of LEXAPRO in major depressive disorder, activation of mania/hypomania was reported in one (0.1%) of 715 patients treated with LEXAPRO and in none of the 592 patients treated with placebo. One additional case of hypomania has been reported in association with LEXAPRO treatment. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorders treated with racemic citalopram and other marketed drugs effective in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, LEXAPRO should be used cautiously in patients with a history of mania.

Seizures
Although anticonvulsant effects of racemic citalopram have been observed in animal studies, LEXAPRO has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies during the product's premarketing testing. In clinical trials of LEXAPRO, cases of convulsion have been reported in association with LEXAPRO treatment. Like other drugs effective in the treatment of major depressive disorder, LEXAPRO should be introduced with care in patients with a history of seizure disorder.

Suicide
The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high risk patients should accompany initial drug therapy. As with all drugs effective in the treatment of major depressive disorder, prescriptions for LEXAPRO should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Interference with Cognitive and Motor Performance
In a study in normal volunteers, LEXAPRO 10 mg/day did not produce impairment of intellectual function or psychomotor performance. Because any psychoactive drug may impair judgment, thinking, or motor skills, however, 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.

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Lexapro Information for Patients

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

In a study in normal volunteers, LEXAPRO 10 mg/day did not impair psychomotor performance. The effect of LEXAPRO on psychomotor coordination, judgment, or thinking has not been systematically examined in controlled studies. 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.

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.

Patients should be made aware that escitalopram is the active isomer of Celexa (citalopram hydrobromide) and that the two medications should not be taken concomitantly.

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.

Patients should be cautioned about the concomitant use of LEXAPRO and NSAIDs, aspirin, or other drugs that affect coagulation since the combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding.
Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.
Patients should be advised to notify their physician if they are breast feeding an infant.

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

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