Lexapro

DRUG DESCRIPTION

Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1[3-(dimethyl-amino)propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:

Lexapro® (escitalopram oxalate) Structural Formula Illustration

The molecular formula is C20H21FN2O •C2H2O4 and the molecular weight is 414.40.

Escitalopram oxalate occurs as a fine, white to slightly-yellow powder and is freely soluble in methanol and dimethyl sulfoxide (DMSO), soluble in isotonic saline solution, sparingly soluble in water and ethanol, slightly soluble in ethyl acetate, and insoluble in heptane.

Lexapro (escitalopram oxalate) is available as tablets or as an oral solution.

Lexapro tablets are film-coated, round tablets containing escitalopram oxalate in strengths equivalent to 5 mg, 10 mg, and 20 mg escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol.

Lexapro oral solution contains escitalopram oxalate equivalent to 1 mg/mL escitalopram base. It also contains the following inactive ingredients: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor.

What are the possible side effects of escitalopram (Lexapro)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have...

Read All Potential Side Effects and See Pictures of Lexapro »

What are the precautions when taking escitalopram oxalate (Lexapro)?

Before taking escitalopram, tell your doctor or pharmacist if you are allergic to it; or to citalopram; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, liver disease, seizures, kidney disease, stomach bleeding (such as ulcers), severe loss of body water (dehydration), low sodium in the blood (hyponatremia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any...

Read All Potential Precautions of Lexapro »


Lexapro Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, dry mouth, trouble sleeping, constipation, tiredness, drowsiness, dizziness, or increased sweating may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual or severe mental/mood changes (such as confusion, difficulty concentrating, nervousness, unusual high energy/excitement, rare thoughts of suicide), decreased interest in sex, changes in sexual ability.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bruising/bleeding, muscle weakness/cramps, change in the amount of urine.

Get medical help right away if any of these rare but serious side effects occur: bloody/black/tarry stools, fainting, vomit that looks like coffee grounds, seizures.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitching muscles.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking escitalopram, tell your doctor or pharmacist if you are allergic to it; or to citalopram; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, liver disease, seizures, kidney disease, stomach bleeding (such as ulcers), severe loss of body water (dehydration), low sodium in the blood (hyponatremia).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug. They may be more likely to lose too much salt (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated depression can be a serious condition, do not stop using this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Lexapro Patient Information Including Side Effects

Brand Names: Lexapro

Generic Name: escitalopram (Pronunciation: ES sye TAL oh pram)

  • What is escitalopram (Lexapro)?
  • What are the possible side effects of escitalopram (Lexapro)?
  • What is the most important information I should know about escitalopram (Lexapro)?
  • What should I discuss with my healthcare provider before taking escitalopram (Lexapro)?
  • How should I take escitalopram (Lexapro)?
  • What happens if I miss a dose (Lexapro)?
  • What happens if I overdose (Lexapro)?
  • What should I avoid while taking escitalopram (Lexapro)?
  • What other drugs will affect escitalopram (Lexapro)?
  • Where can I get more information?

What is escitalopram (Lexapro)?

Escitalopram is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Escitalopram affects chemicals in the brain that may become unbalanced and cause depression or anxiety.

Escitalopram is used to treat anxiety in adults and major depressive disorder in adults and adolescents who are at least 12 years old.

Escitalopram may also be used for other purposes not listed in this medication guide.

What are the possible side effects of escitalopram (Lexapro)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
  • nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
  • headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • drowsiness, dizziness;
  • sleep problems (insomnia);
  • mild nausea, gas, heartburn, upset stomach, constipation;
  • weight changes;
  • decreased sex drive, impotence, or difficulty having an orgasm; or
  • dry mouth, yawning, ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about escitalopram (Lexapro)?

Do not take escitalopram together with a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take escitalopram. After you stop taking escitalopram, you must wait at least 14 days before you start taking an MAOI.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking escitalopram, do not stop taking the medication without first talking to your doctor.

It is dangerous to try and purchase escitalopram on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of escitalopram purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

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