ESCITALOPRAM OXALATE  - escitalopram oxalate solution 
Camber Pharmaceuticals, Inc.

----------

MEDICATION GUIDE


Read the Medication Guide that comes with escitalopram oxalate oral solution 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 oxalate oral solution?

Escitalopram oxalate oral solution and other antidepressant medicines may cause serious side effects, including:
 
1. Suicidal thoughts or actions: 
   • E scitalopram oxalate oral solution 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 oxalate oral solution 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 mod
 
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Escitalopram oxalate oral solution may be associated with these serious side effects:


2. Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. 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 oxalate oral solution 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 oxalate oral solution without first talking to your healthcare provider. Stopping escitalopram oxalate oral solution 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 oxalate oral solution?
Escitalopram oxalate oral solution 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 oxalate oral solution 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 oxalate oral solution treatment.

Who should not take escitalopram oxalate oral solution?
Do not take escitalopram oxalate oral solution if you: 
• are allergic to escitalopram oxalate or citalopram hydrobromide or any of the ingredients in escitalopram oxalate oral solution. See the end of this Medication Guide for a complete list of ingredients in escitalopram oxalate oral solution. 
• 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 14 days of stopping escitalopram oxalate oral solution. 
         • Do not start escitalopram oxalate oral solution if you stopped taking an MAOI in the last 14 days.

People who take escitalopram oxalate oral solution 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 oxalate oral solution can cause serious heart problems.

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

Before starting escitalopram oxalate oral solution, 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 oxalate oral solution 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 escitalopram oxalate oral solution may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking escitalopram oxalate oral solution.
 
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Escitalopram oxalate oral solution 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 oxalate oral solution with your other medicines. Do not start or stop any medicine while taking escitalopram oxalate oral solution without talking to your healthcare provider first.


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

 
How should I take escitalopram oxalate oral solution? 
            • Take escitalopram oxalate oral solution exactly as prescribed. Your healthcare provider may need to change the dose of escitalopram oxalate oral solution until it is the right dose for you. 
            • Escitalopram oxalate oral solution may be taken with or without food. 
            • If you miss a dose of escitalopram oxalate oral solution, 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 oxalate oral solution at the same time. 
            • If you take too much escitalopram oxalate oral solution, call your healthcare provider or poison control center right away, or get emergency treatment.
 
What should I avoid while taking escitalopram oxalate oral solution?
 Escitalopram oxalate oral solution 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 oxalate oral solution affects you. Do not drink alcohol while using escitalopram oxalate oral solution.
 
What are the possible side effects of escitalopram oxalate oral solution?
Escitalopram oxalate oral solution 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 oxalate oral solution?”
 
Common possible side effects in people who take escitalopram oxalate oral solution 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 oxalate oral solution.

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 oxalate oral solution. 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 oxalate oral solution? 
         • Store escitalopram oxalate oral solution at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature]
         • Keep escitalopram oxalate oral solution bottle closed tightly.

Keep escitalopram oxalate oral solution and all medicines out of the reach of children.

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

This Medication Guide summarizes the most important information about escitalopram oxalate oral solution. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram oxalate oral solution that is written for healthcare professionals.
 
What are the ingredients in escitalopram oxalate oral solution?
Active ingredient: escitalopram oxalate

Inactive ingredients:  anhydrous citric acid, glycerin, malic acid, methylparaben, natural peppermint flavor, non-crystallizing sorbital solution, propylene glycol, propylparaben, purified water and sodium citrate dihydrate.

Manufactured for:                         2014779
Camber Pharmaceuticals, Inc. 
Piscataway, NJ 08854

By: Hetero Labs Limited
Jeedimetla, Hyderabad – 500 055, India.  
                                        
Revised 10/2011

Coumadin ®, Jantoven ® and Orap ® are the registered trademarks of their respective owners and are not the trademarks of Hetero Labs Limited.
 
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 10/2011
Camber Pharmaceuticals, Inc.