Lexapro ESCITALOPRAM OXALATE
Refer to the “Also Known As” section to reference different products that include the same medication as Lexapro.
Brand Name: Lexapro
Generic Name: ESCITALOPRAM OXALATE
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET, FILM COATED
Data Current As Of: 2019-01-21
indications & 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.
drug abuse & dependence
abuse & dependence
Physical and Psychological Dependence
Animal studies suggest that the abuse liability of racemic citalopram is low. Lexapro has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with Lexapro did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate Lexapro patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).
patient counseling information
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 )].
Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of Lexapro with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid) [see Warnings and Precautions ( 5.2 )].
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 )].
Angle Closure Glaucoma
Patients should be advised that taking Lexapro can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions ( 5.9 )].
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.
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.
Pregnan c y 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 pediatric 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.
2 fda-approved medication guide
Read the Medication Guide that comes with Lexapro before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about Lexapro?
Lexapro and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- Lexapro and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice:
∙ New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
∙ Pay particular attention to such changes when Lexapro is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety or panic attacks
- feeling agitated, restless, angry or irritable
- trouble sleeping
- an increase in activity or talking more than what is normal for you
- other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Lexapro may be associated with these serious side effects:
2. Serotonin Syndrome. This condition can be life-threatening and may include:
- agitation, hallucinations, coma or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity
3. Severe allergic reactions:
- trouble breathing
- swelling of the face, tongue, eyes or mouth
- rash, itchy welts (hives) or blisters, alone or with fever or joint pain
4. Abnormal bleeding: Lexapro and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. Seizures or convulsions
6. Manic episodes:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
9. Visual problems
- eye pain
- changes in vision
- swelling or redness in or around the eye
Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
Do not stop Lexapro without first talking to your healthcare provider. Stopping Lexapro too quickly may cause serious symptoms including:
- anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
- headache, sweating, nausea, dizziness
- electric shock-like sensations, shaking, confusion
What is Lexapro?
Lexapro is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Lexapro is also used to treat:
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
Talk to your healthcare provider if you do not think that your condition is getting better with Lexapro treatment.
Who should not take Lexapro?
Do not take Lexapro if you:
- are allergic to escitalopram or citalopram or any of the ingredients in Lexapro. See the end of this Medication Guide for a complete list of ingredients in Lexapro.
- take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or a pharmacist if you are not sure if you take an MAOI, including linezolid.
- Do not take an MAOI within 2 weeks of stopping Lexapro unless directed to do so by your physician.
- Do not start Lexapro if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take Lexapro close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- loss of consciousness (pass out)
- Do not take Lexapro with Orap® (pimozide) because taking these two drugs together can cause serious heart problems.
What should I tell my healthcare provider before taking Lexapro? Ask if you are not sure.
Before starting Lexapro, tell your healthcare provider if you:
- Are taking certain drugs such as:
∙ Triptans used to treat migraine headache
∙ Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, amphetamines, or antipsychotics
∙ Over-the-counter supplements such as tryptophan or St. John’s Wort
- have liver problems
- have kidney problems
- have heart problems
- have or had seizures or convulsions
- have bipolar disorder or mania
- have low sodium levels in your blood
- have a history of a stroke
- have high blood pressure
- have or had bleeding problems
- are pregnant or plan to become pregnant. It is not known if Lexapro will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
- are breast-feeding or plan to breast-feed. Some Lexapro may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Lexapro.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Lexapro and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take Lexapro with your other medicines. Do not start or stop any medicine while taking Lexapro without talking to your healthcare provider first.
|If you take Lexapro, you should not take any other medicines that contain escitalopram or citalopram including: Celexa|
How should I take Lexapro?
- Take Lexapro exactly as prescribed. Your healthcare provider may need to change the dose of Lexapro until it is the right dose for you.
- Lexapro may be taken with or without food.
- If you miss a dose of Lexapro, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Lexapro at the same time.
- If you take too much Lexapro, call your healthcare provider or poison control center right away, or get emergency treatment.
What should I avoid while taking Lexapro?
Lexapro can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Lexapro affects you. Do not drink alcohol while using Lexapro.
What are the possible side effects of Lexapro?
Lexapro may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about Lexapro?”
Common possible side effects in people who take Lexapro include:
- Feeling anxious
- Trouble sleeping
- Sexual problems
- Not feeling hungry
- Dry mouth
Other side effects in children and adolescents include:
- increased thirst
- abnormal increase in muscle movement or agitation
- nose bleed
- difficult urination
- heavy menstrual periods
- possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with Lexapro.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Lexapro. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
How should I store Lexapro?
- Store Lexapro at 68°F to 77°F (20°C to 25°C) ; excursions permitted to 59°F to 86°F (15°C to 30°C) .
- Keep Lexapro bottle closed tightly.
Keep Lexapro and all medicines out of the reach of children.
General information about Lexapro
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lexapro for a condition for which it was not prescribed. Do not give Lexapro to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about Lexapro. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Lexapro that is written for healthcare professionals.
For more information about Lexapro call 1-800-678-1605 or go to www.Lexapro.com.
What are the ingredients in Lexapro?
Active ingredient: escitalopram oxalate
- Tablets: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.
- Oral Solution: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.
Allergan USA, Inc.
Madison, NJ 07940
Licensed from H. Lundbeck A/S
This Medication Guide has been approved by the U.S. Food and Drug Administration.
© 2019 Allergan. All rights reserved.
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