Download Lexapro (escitalopram)

Lexapro (escitalopram)
FDA ALERT [09/2007] - Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior
(suicidality) in children, adolescents, and young adults in short-term studies of major
depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use
of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance
this risk with the clinical need. Short-term studies did not show an increase in the risk of
suicidality with antidepressants compared to placebo in adults beyond age 24; there was a
reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves associated with
increases in the risk of suicide. Patients of all ages who are started on antidepressant
therapy should be monitored appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and caregivers should be advised of
the need for close observation and communication with the prescriber. Lexapro is not
approved for use in pediatric patients.
Available as:
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Tablets: 5 mg, 10 mg, 20 mg
Liquid: 5 mg/5mL (teaspoonful)
What is Lexapro® and what does it treat?
Escitalopram is a selective serotonin reuptake inhibitor (or "SSRI") that is used to treat
Major Depressive disorder (also, Major Depression or MDD). In addition, escitalopram is
effective, and FDA approved, for the treatment of Generalized Anxiety Disorder (GAD).
Key elements to both illnesses are that untreated symptoms remain in place over long
periods of time, and that while untreated the person’s functioning in day–to–day life is
significantly decreased.
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Major Depression is when a person experiences several of the following symptoms at the
same time: "low" or depressed mood (for example, sad, empty, tearful), decreased
interest in most or all activities, changes in appetite (usually decreased), changes in sleep
(usually poor sleep), loss of energy, feeling worthless/guilty/ hopeless/ helpless, difficulty
concentrating, thoughts of death (suicidal thinking).
Generalized anxiety disorder is when a person experiences several of the following
symptoms at the same time: excessive and difficult to control anxiety or worrying, feeling
restless or "keyed–up" or "on edge", becoming tired very easily, difficulty concentrating,
irritability, muscle tension, and difficulty falling and/or staying asleep.
Escitalopram may be used for other anxiety or mood disorders such as panic disorder,
social anxiety disorder, obsessive compulsive disorder, post-traumatic stress disorder or
bipolar depression as determined by an individual’s health care provider.
What is the most important information I should know about Lexapro®?
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After starting an SSRI and taking it every day, symptoms usually begin to
improve during the first 1–2 weeks. Maximal improvement is usually seen after
4–6 weeks. Once symptoms are under control, MDD and GAD usually require
long-term treatment. Only your healthcare provider can determine the length of
escitalopram treatment that is right for you.
Do not stop taking escitalopram or change your dose without talking with your
healthcare provider first.
Stopping escitalopram abruptly can result in one or more of the following
withdrawal effects: irritability, restlessness, dizziness, numbness, anxiety,
confusion, headache, feeling tired, “shooting” pains in the arms or legs, and
difficulty sleeping.
Patients with Major Depression or other mental illnesses may sometimes think
about, or attempt, suicide. Closely watch anyone taking antidepressants,
especially early in treatment or when the dose is changed. Patients who become
extremely irritable or anxious, or have new or increased thoughts of suicide or
other changes in mood or behavior should contact their healthcare professional
right away.
Children(18 years or younger) taking antidepressants experience suicidal thoughts or
actions in about 1 out of every 50 who are depressed. Although escitalopram is often
prescribed for children with Major Depression or anxiety disorders, the FDA has not
approved escitalopram for use in this age group.
Adults: several recent scientific publications report the possibility of an increased risk for
suicidal behavior in adults who are being treated with antidepressant medications. Even
before these reports became available, FDA began a complete review of all available data
to determine whether there is an increased risk of suicidal thinking or behavior in adults
being treated with antidepressant medications. It is expected that this review will take a
year or longer to complete. In the meantime, FDA is highlighting that adults being treated
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with antidepressant medication, particularly those being treated for Major Depression,
should be watched closely for worsening of Major Depression and for increased suicidal
thinking or behavior.
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Because depression can also be a part of Bipolar illness, people who take
antidepressants may be at risk for “switching” from depression into mania.
Symptoms of mania include “high” or irritable mood, very high self esteem,
decreased need for sleep, pressure to keep talking, racing thoughts, being easily
distracted, frequently involved in activities with a large risk for bad consequences
(for example, excessive buying sprees). Contact a healthcare professional
immediately to prevent further worsening of symptoms.
Escitalopram may interact with medications you are currently taking, or that may
be added in the future. Be sure that you know all of your medications so that your
doctor or pharmacist can know if any drug–drug interactions are occurring.
You should not drink alcohol or use illegal drugs while taking escitalopram.
Are there specific concerns about Lexapro® and pregnancy?
If you are planning on becoming pregnant, notify your healthcare provider so that he/she
can best manage your medications. People living with MDD or GAD who wish to
become pregnant face important decisions, each with risks and benefits as it relates to
how the illness, medications and the risks to the fetus may interact. This is a complex
decision as untreated MDD or GAD has risk as well to mother and fetus. There are many
dimensions to these choices, so be sure to confer with your doctor and caregivers.
Since escitalopram is a newer medication, there is less information about its use in
pregnant women. Escitalopram has caused birth defects in animals, but there are no
human studies. Most reports about SSRIs indicate that birth defects do not occur more
commonly when compared with babies born to mothers taking no medications. However,
babies born to mothers who have taken SSRIs do seem to be at risk for withdrawal
effects. These symptoms can include: breathing and eating difficulties, colicky
symptoms, increased reflexes, increased or decreased muscle tone, irritability, constant
crying, and seizures. Before your baby is born, you may wish to discuss the possibility of
decreasing, and then stopping, escitalopram with your healthcare provider in order to
decrease your baby’s risk of withdrawal.
For mothers who have taken SSRIs during their pregnancy, there appears to be less than a
1% chance of infants developing persistent pulmonary hypertension. This is a potentially
fatal condition that is associated with use of the antidepressant in the second half of
pregnancy. However, women who discontinued antidepressant therapy were five times
more likely to have a depression relapse than those who continued their antidepressant. If
you are pregnant, please discuss the risks and benefits of antidepressant use with your
healthcare provider.
Regarding breast-feeding, caution is advised since escitalopram does pass into breast
milk.
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What should I discuss with my healthcare provider before taking Lexapro®?
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Symptoms that are most bothersome to you about your condition
If you have thoughts of suicide
Medications you have taken in the past to treat MDD or GAD
All other medications you are currently taking and any medication allergies you
have.
Any medication side effects that you may have experienced in the past, or are
currently experiencing
If you are pregnant, plan to become pregnant, or are breast-feeding
If you drink alcohol or use illegal drugs
Any medical problems you have.
How should I take Lexapro®?
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Escitalopram is usually taken once a day, and may be taken with or without food.
Your healthcare provider will determine the dose that is right for you based upon
your response.
Use a pillbox or calendar to help you remember to take your medication.
What happens if I miss a dose of Lexapro®?
If you miss a dose of escitalopram, take it as soon as you remember to. But only if it is
not too close to when your next dose is due. If it is close to your next dose, wait until then
to take the medication and skip the missed dose. Do not double your next dose or take
more than your prescribed dose. Discussing this scenario with your healthcare provider
ahead of time is advised.
What should I avoid while taking Lexapro®?
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In some patients, escitalopram may cause dizziness or drowsiness. Make sure you
know how you react to this medication before you drive, operate machinery, or do
other activities that may be dangerous if you are not alert.
Avoid drinking alcohol or using illegal drugs while you are taking escitalopram.
Avoid skipping or missing doses of this medication. Escitalopram is meant to be
taken on a daily basis in order to get your symptoms under control. Once
symptoms are controlled, escitalopram should still be taken on a daily basis for
the best long-term results in treating treating symptoms and preventing relapse.
What happens if I overdose with Lexapro®?
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If an overdose occurs, whether intentional or accidental, immediate medical
attention is necessary. Call your doctor or emergency medical service (911).
Symptoms that may occur in an overdose: seizures, coma, dizziness, low blood
pressure, insomnia, nausea, vomiting, rapid heart rate, drowsiness, and changes in
heart rhythm. In rare instances, death has occurred.
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What are the possible side effects of Lexapro®?
Common side effects of escitalopram include: dry mouth, increased sweating, dizziness,
nausea, diarrhea or constipation, feeling tired, insomnia, and sexual side effects. For
women, sexual side effects include being unable to experience an orgasm. For men,
sexual side effects include not being unable to gain or maintain an erection (impotence),
delayed ejaculation, or anorgasmia. If you are experiencing a decreased interest in having
sexual activity, then this may be more likely to be an untreated symptom of your Major
Depression.
Rare, but serious, side effects of escitalopram include: bleeding, decreased sodium levels
in the blood (risk for seizures), “switching” from depression to mania, and seizures. As
stated above, people being treated for MDD are at risk for suicidal thinking—careful
attention is needed for patients who are either starting antidepressants, or who are having
the dose of their antidepressant increased.
Another rare, but serious side effect of SSRIs is the Serotonin Syndrome. When this
occurs, people experience several of the following symptoms at the same time: inner
restlessness, tremor (shaking), confusion, muscle spasms/jerking, muscle stiffness, and
increased body temperature. Serotonin syndrome in rare cases is life threatening.
Talk with your healthcare provider if you experience any side effects that are bothersome
to you.
Are there any risks for taking Lexapro® for long periods of time?
There are no known risks for taking escitalopram for long periods of time.
What other drugs may interact with Lexapro®?
Escitalopram may increase the medication levels of several other medications by slowing
down their breakdown and elimination from the body. Examples of these medications
include the following:
Beta Blockers
Lopressor (metoprolol)
Inderal (propranolol)
Antidepressants
Tricyclic antidepressants (older)– Elavil (amitriptyline), Pamelor (nortriptyline), Tofranil
(imipramine), Norpramin (desipramine), Anafranil (clomipramine)
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Newer antidepressants– Cymbalta (duloxetine), Prozac (fluoxetine), Paxil (paroxetine),
Effexor (venlafaxine)
Antipsychotics
Typical (older)– Thorazine (chlorpromazine), Mellaril (thioridazine), Trilafon
(perphenazine), Haldol (haloperidol)
Atypical (newer)– Abilify (aripiprazole), Risperdal (risperidone)
Other
Dexedrine (dextroamphetamine)
Strattera (atomoxetine)
Codeine
Ultram (tramadol)
Meridia (sibutramine)
Emsam, Eldepryl (selegeline)
Some medications, such as Prozac (fluoxetine) and Luvox (fluvoxamine) may increase
the blood levels of escitalopram. It is possible that patients taking escitalopram with
either of these agents may experience a change in side effects. Tell your doctor if you
begin or stop taking fluoxetine or fluvoxamine therapy. Biaxin (clarithromycin),
erythromycin, Cardizem (diltiazem), Nizoral (ketoconazole), Calan (verapamil), Accolate
(zafirlukast) may also increase blood levels of escitalopram.
Studies have shown that Tegretol (carbamazepine; an anticonvulsant commonly used as a
mood stabilizer to treat bipolar disorder) can decrease the amount of escitalopramin the
blood. Medications with similar effects to carbamazepine include: Sustiva (efavirenz),
Fulvicin (griseofulvin), Mysoline (primidone), Dilantin (phenytoin), Rezulin
(troglitazone).
Escitalopram should not be taken with monoamine oxidase inhibitors (MAOIs) since
symptoms of the serotonin syndrome have occurred.
Escitalopram may also interact with Orap (pimozide) which can cause abnormal heart
rhythms—while this is rare, these abnormal heart rhythms can result in death.
Escitalopram may also interact with Imitrex (sumatriptan) possibly causing symptoms of
the serotonin syndrome—while this is rare, the serotonin syndrome can result in death.
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This interaction may also occur with other “triptans” that work in a similar way to
Imitrex.
How long does it take for Lexapro® to work?
Several weeks are often required for escitalopram to reach its maximum effectiveness;
however, improvement in some symptoms may occur sooner.
Updated by
Charles F. Caley, Pharm.D., BCPP
(August 2006)
NAMI wishes to thank the College of Psychiatric and Neurological Pharmacists for
producing this fact sheet.
Reviewed by Dr. Ken Duckworth, NAMI Medical Director
For further information. Please contact the pharmaceutical company listed below.
Forest
Pharmaceuticals
13600 Shoreline
Drive
St. Louis, MO
63045
800-678-1605
www.forestpharm.com
Free or low-cost medications provided by pharmaceutical companies
Some pharmaceutical companies offer medication assistance programs to low-income
individuals and families. These programs typically require a doctor’s consent and proof
of financial status. They may also require that you have either no health insurance, or no
prescription drug benefit through your health insurance. Please contact the
pharmaceutical company directly for specific eligibility requirements and application
information.
Lexapro Rx Assistance Program: 1-800-851-0758
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