ESCITALOPRAM- escitalopram oxalate tablet, film coated 
Teva Pharmaceuticals USA Inc

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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:

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.
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:
1.
New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
2.
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:

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. Escitalopram 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: 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:

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:

headache
weakness or feeling unsteady
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:

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 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:

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 escitalopram treatment.

Who should not take escitalopram?

Do not take escitalopram if you:

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.
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.
1.
Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.
2.
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)
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:

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
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 escitalopram will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
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.

If you take escitalopram, you should not take any other medicines that contain escitalopram oxalate or citalopram hydrobromide including: Celexa.

Revised: 09/2014
 
Teva Pharmaceuticals USA Inc