17.2 FDA APPROVED MEDICATION GUIDE

MEDICATION GUIDE

Escitalopram (ES-sye-TAL-oh-pram) Tablets USP

Read the Medication Guide that comes with escitalopram 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 escitalopram?

Escitalopram and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

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Escitalopram 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.

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Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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Watch for these changes and call your healthcare provider right away if you notice:

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New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.

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Pay particular attention to such changes when escitalopram 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:

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attempts to commit suicide

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acting on dangerous impulses

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acting aggressive or violent

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thoughts about suicide or dying

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new or worse depression

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new or worse anxiety or panic attacks

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feeling agitated, restless, angry or irritable

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trouble sleeping

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an increase in activity or talking more than what is normal for you

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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. Escitalopram may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:

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agitation, hallucinations, coma or other changes in mental status

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coordination problems or muscle twitching (overactive reflexes)

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racing heartbeat, high or low blood pressure

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sweating or fever

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nausea, vomiting, or diarrhea

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muscle rigidity

3. Severe allergic reactions:

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trouble breathing

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swelling of the face, tongue, eyes or mouth

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rash, itchy welts (hives) or blisters, alone or with fever or joint pain

 

4. Abnormal bleeding: Escitalopram and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

5. Seizures or convulsions

6. Manic episodes:

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greatly increased energy

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severe trouble sleeping

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racing thoughts

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reckless behavior

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unusually grand ideas

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excessive happiness or irritability

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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:

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headache

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weakness or feeling unsteady

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confusion, problems concentrating or thinking or memory problems

Do not stop escitalopram without first talking to your healthcare provider. Stopping escitalopram too quickly may cause serious symptoms including:

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anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

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headache, sweating, nausea, dizziness

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electric shock-like sensations, shaking, confusion

What is escitalopram?

Escitalopram 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. Escitalopram is also used to treat:

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Major Depressive Disorder (MDD)

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Generalized Anxiety Disorder (GAD)

Talk to your healthcare provider if you do not think that your condition is getting better with escitalopram treatment.

Who should not take escitalopram?

Do not take escitalopram if you:

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are allergic to escitalopram oxalate or citalopram hydrobromide or any of the ingredients in escitalopram. See the end of this Medication Guide for a complete list of ingredients in escitalopram.

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If you take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.

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Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.

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Do not start escitalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take escitalopram 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

 

confusion

 

loss of consciousness (pass out)

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take the antipsychotic medicine pimozide (Orap®) because taking this drug with escitalopram can cause serious heart problems. 

What should I tell my healthcare provider before taking escitalopram? Ask if you are not sure.

Before starting escitalopram, tell your healthcare provider if you:

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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, or antipsychotics

 

tramadol

 

Over-the-counter supplements such as tryptophan or St. John’s Wort

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have liver problems

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have kidney problems

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have heart problems

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have or had seizures or convulsions

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have bipolar disorder or mania

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have low sodium levels in your blood

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have a history of a stroke

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have high blood pressure

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have or had bleeding problems

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are pregnant or plan to become pregnant. It is not known if escitalopram will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy

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are breastfeeding or plan to breastfeed. Some escitalopram may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking escitalopram.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Escitalopram 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 escitalopram with your other medicines. Do not start or stop any medicine while taking escitalopram without talking to your healthcare provider first.