Escitalopram (Page 9 of 10)

14.2 Generalized Anxiety Disorder

The efficacy of escitalopram in the acute treatment of Generalized Anxiety Disorder (GAD) was demonstrated in three, 8 week, multicenter, flexible-dose, placebo-controlled studies that compared escitalopram 10 to 20 mg/day to placebo in adult outpatients between 18 and 80 years of age who met DSM-IV criteria for GAD. In all three studies, escitalopram showed statistically significant greater mean improvement compared to placebo on the Hamilton Anxiety Scale (HAM-A).

There were too few patients in differing ethnic and age groups to adequately assess whether or not escitalopram has differential effects in these groups. There was no difference in response to escitalopram between men and women.

16 HOW SUPPLIED/STORAGE AND HANDLING

Escitalopram Tablets USP, 10 mg are available as white to off-white, round, biconvex, scored, film-coated tablets, debossed “5851” on one side and “company logo”, a score, and “10” on the other side, packaged in bottles of 30 tablets.

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure as required.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Medication Guide

17.1 Information for Patients

Physicians are advised to discuss the following issues with patients for whom they prescribe escitalopram.

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 escitalopram 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 escitalopram. 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 escitalopram.

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) ].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of escitalopram with other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol tryptophan, buspirone 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) ].

Abnormal Bleeding

Patients should be cautioned about the concomitant use of escitalopram 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) ].

Concomitant Medications

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 escitalopram 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 escitalopram therapy does not affect their ability to engage in such activities.

Alcohol

Patients should be told that, although escitalopram has not been shown in experiments with normal subjects to increase the mental and motor skill impairments caused by alcohol, the concomitant use of escitalopram and alcohol in depressed patients is not advised.

Pregnancy and Breastfeeding

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

Escitalopram 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 escitalopram in MDD has not been established in pediatrics 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.

Manufactured In India By:

CIPLA LTD.

Kurkumbh, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 12/2012

Repackaged by:

REBEL DISTRIBUTORS CORP.

Thousand Oaks, CA 91320

Medguide

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

How should I take escitalopram?

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

What should I avoid while taking escitalopram?

Escitalopram 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 affects you. Do not drink alcohol while using escitalopram.

What are the possible side effects of escitalopram?

Escitalopram 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?

Common possible side effects in people who take escitalopram 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.

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. 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?

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

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

General information about escitalopram

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

escitalopram for a condition for which it was not prescribed. Do not give escitalopram to other people, even if they have the same condition. It may harm them.

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

For more information about escitalopram call Teva Pharmaceuticals Medical Affairs at 1-888-838-2872.

What are the ingredients in escitalopram?

Active ingredient: escitalopram oxalate, USP

Inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

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

Manufactured In India By:

CIPLA LTD.

Kurkumbh, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 12/2012

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Repackaged by:

REBEL DISTRIBUTORS CORP.

Thousand Oaks, CA 91320

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