ESCITALOPRAM- escitalopram oxalate tablet, film coated 
American Health Packaging

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17.2 FDA-Approved Medication Guide


Medication Guide

Escitalopram Tablets USP

Read the Medication Guide that comes with escitalopram tablets before you start taking them 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 tablets?

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

1.  Suicidal thoughts or actions: 

Escitalopram tablets 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 escitalopram tablets are 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 tablets 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 tablets 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: 

headache
weakness or feeling unsteady
confusion, problems concentrating or thinking or memory problems

Do not stop escitalopram tablets without first talking to your healthcare provider. Stopping escitalopram tablets 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 are escitalopram tablets?

Escitalopram tablets are 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 tablets are 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 tablets treatment.

Who should not take escitalopram tablets?

Do not take escitalopram tablets if you: 

are allergic to escitalopram oxalate or citalopram hydrobromide or any of the ingredients in escitalopram tablets. See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets.
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.
Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.
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 tablets 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 tablets can cause serious heart problems.


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

Before starting escitalopram tablets, 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 tablets 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 oxalate may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking escitalopram tablets.


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


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

How should I take escitalopram tablets? 

Take escitalopram tablets exactly as prescribed. Your healthcare provider may need to change the dose of escitalopram tablets until it is the right dose for you.
Escitalopram tablets may be taken with or without food.
If you miss a dose of escitalopram tablets, 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 escitalopram tablets at the same time.
If you take too much escitalopram oxalate, call your healthcare provider or poison control center right away, or get emergency treatment.


What should I avoid while taking escitalopram tablets?

Escitalopram tablets 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 escitalopram tablets affect you. Do not drink alcohol while using escitalopram tablets.

What are the possible side effects of escitalopram tablets?

Escitalopram tablets may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about escitalopram tablets?”

Common possible side effects in people who take escitalopram tablets include: 

Nausea
Sleepiness
Weakness
Dizziness
Feeling anxious
Trouble sleeping
Sexual problems
Sweating
Shaking
Not feeling hungry
Dry mouth
Constipation
Infection
Yawning

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 escitalopram tablets.


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 escitalopram tablets. 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 escitalopram tablets? 

Store escitalopram tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).


Keep escitalopram tablets and all medicines out of the reach of children.

General information about escitalopram tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use escitalopram tablets for a condition for which it was not prescribed. Do not give escitalopram tablets to other people, even if they have the same condition. They may harm them.

This Medication Guide summarizes the most important information about escitalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram tablets that is written for healthcare professionals.

For more information about escitalopram tablets call Aurobindo Pharma USA 1-866-850-2876.

What are the ingredients in escitalopram tablets?

Active ingredient: escitalopram oxalate

Inactive ingredients: butylated hydroxyl anisole, butylated hydroxy toluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and talc. The film coating contains hypromellose, polyethylene glycol 400, and titanium dioxide.

Coumadin® is a registered trademark of Bristol Myers Squibb.
Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.
Orap® is a registered trademark of Teva Pharmaceuticals USA.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Packaged and Distributed by:

American Health Packaging

Columbus, OH 43217

8261701/0413

Revised: 07/2013
 
American Health Packaging