Escitalopram

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Lexapro is approved for the treatment of depression and generalized anxiety disorder.
• Drugs in the SSRI class also are used for treating obsessive compulsive disorders and panic disorders, although Lexapro is not approved for these purposes.

Pregnancy

Pregnancy category: C

Use late in the third trimester associated with complications in newborns and may require prolonged hospitalization, respiratory support, and tube feeding

Persistent pulmonary hypertension of the newborn

• Potential risk of persistent pulmonary hypertension of the newborn when used during pregnancy
• Initial Public Health Advisory in 2006 was based on a single published study; since then, there have been conflicting findings from new studies, making it unclear whether use of SSRIs during pregnancy can cause PPHN
• FDA has reviewed the additional new study results and has concluded that, given the conflicting results from different studies, it is premature to reach any conclusion about a possible link between SSRI use in pregnancy and PPHN
• FDA recommendation: FDA advises health-care professionals not to alter their current clinical practice of treating depression during pregnancy and to report any adverse events to the FDA MedWatch program
• A meta-analysis of 7 observational studies, found exposure to SSRIs in late pregnancy (ie, >20 weeks' gestation) more than doubled the risk of PPHN that could not be explained by other etiologies (eg, congenital malformations, meconium aspiration) (BMJ 2014;348:f6932)

Lactation

Excreted in breast milk; consider risk/benefit ratio

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Escitalopram is a prescription medicine used to treat depression and anxiety in people over 12 years of age.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Escitalopram may be found in some form under the following brand names:

• Lexapro

Tell your doctor if you are breastfeeding or plan to breastfeed. Some escitalopram may pass into your breast milk. It is not known if escitalopram will harm your nursing baby.

Take escitalopram exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended dosage of escitalopram is 10-20 mg a day. Exceptions include the elderly and patients with hepatic impairment, who should not take more than 10 mg a day. Both Generalized Anxiety Disorder (GAD) and Depression are considered chronic conditions, treatment is recommended for several months. The efficacy of Lexapro over long periods of time has not been studied, therefore consistent reevaluation of the treatment is recommended for longer periods of treatment.

If you take too much escitalopram, call your doctor or Poison Control Center right away, or get emergency treatment.

You should not use this medicine you also take pimozide (Orap) or citalopram (Celexa).

Do not use escitalopram within 14 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Do not give this medicine to anyone under 12 years.

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

Report any new or worsening symptoms to your doctor, 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:

• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;

• racing thoughts, unusual risk-taking behavior, feelings of extreme happiness or sadness;

• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

• dizziness, drowsiness, weakness;

• sweating, feeling shaky or anxious;

• sleep problems (insomnia);

• dry mouth, loss of appetite;

• nausea, constipation;

• yawning;

• weight changes; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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.

Taking escitalopram with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with escitalopram, especially:

• any other antidepressant;

• medicine to treat anxiety, mood disorders, or mental illness;

• lithium, St. John's wort, tramadol, or tryptophan (sometimes called L-tryptophan);

• a blood thinner--warfarin, Coumadin, Jantoven;

• migraine headache medication--sumatriptan, rizatriptan, and others;

• narcotic pain medication--fentanyl or tramadol; or

• stimulants or ADHD medication--Adderall, Concerta, Ritalin, and others;

This list is not complete. Other drugs may interact with escitalopram, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For escitalopram, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to escitalopram or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of escitalopram in children 12 years of age and older with depression. However, safety and efficacy have not been established in children less than 12 years of age. Escitalopram may cause weight loss or a decrease in appetite. Teenagers who will be taking it for a long time should have their weight and growth measured on a regular basis.

Appropriate studies have not been performed on the relationship of age to the effects of escitalopram in children with generalized anxiety disorder. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of escitalopram in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) and age-related liver problems, which may require caution and an adjustment in the dose for patients receiving escitalopram.

Pregnancy

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using escitalopram.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking escitalopram, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using escitalopram with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amifampridine
• Amisulpride
• Bepridil
• Bromopride
• Cisapride
• Clorgyline
• Dronedarone
• Fluconazole
• Furazolidone
• Iproniazid
• Isocarboxazid
• Lazabemide
• Linezolid
• Mesoridazine
• Methylene Blue
• Metoclopramide
• Moclobemide
• Pargyline
• Phenelzine
• Pimozide
• Piperaquine
• Procarbazine
• Rasagiline
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tranylcypromine
• Ziprasidone

Using escitalopram with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Alfuzosin
• Almotriptan
• Amiodarone
• Amitriptyline
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Ancrod
• Anisindione
• Antithrombin III Human
• Apixaban
• Apomorphine
• Ardeparin
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Bemiparin
• Benzphetamine
• Bivalirudin
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Butorphanol
• Cangrelor
• Celecoxib
• Certoparin
• Chloroquine
• Chlorpromazine
• Choline Salicylate
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clonixin
• Clopidogrel
• Clozapine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dalteparin
• Danaparoid
• Dasatinib
• Defibrotide
• Degarelix
• Delamanid
• Dermatan Sulfate
• Desipramine
• Desirudin
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Diclofenac
• Dicumarol
• Diflunisal
• Dihydrocodeine
• Dipyridamole
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Droxicam
• Duloxetine
• Ebastine
• Edoxaban
• Efavirenz
• Eletriptan
• Enoxaparin
• Epoprostenol
• Eptifibatide
• Eribulin
• Erythromycin
• Eslicarbazepine Acetate
• Esomeprazole
• Etodolac
• Etofenamate
• Etoricoxib
• Famotidine
• Felbamate
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Formoterol
• Foscarnet
• Fosphenytoin
• Frovatriptan
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Heparin
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Iloprost
• Imipramine
• Indomethacin
• Iobenguane I 123
• Itraconazole
• Ivabradine
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Meloxicam
• Meperidine
• Methadone
• Methamphetamine
• Metronidazole
• Miconazole
• Mifepristone
• Milnacipran
• Mirtazapine
• Mizolastine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nadroparin
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nepafenac
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Omeprazole
• Ondansetron
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Paliperidone
• Palonosetron
• Panobinostat
• Parecoxib
• Parnaparin
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Pentosan Polysulfate Sodium
• Perphenazine
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piroxicam
• Pitolisant
• Posaconazole
• Pranoprofen
• Prasugrel
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Remifentanil
• Reviparin
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Safinamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertindole
• Sertraline
• Sevoflurane
• Sibutramine
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulpiride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tizanidine
• Tolfenamic Acid
• Tolmetin
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Treprostinil
• Trimipramine
• Triptorelin
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vinflunine
• Vorapaxar
• Voriconazole
• Vorinostat
• Vortioxetine
• Warfarin
• Zolmitriptan
• Zuclopenthixol

Using escitalopram with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir
• Cimetidine
• Ginkgo
• Lamotrigine
• Lithium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of escitalopram. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Bleeding problems or
• Glaucoma, angle-closure or
• Hyponatremia (low sodium in the blood) or
• Mania, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Escitalopram Oxalate
• Lu-26-054
• S-Citalopram

Administer once daily (morning or evening), with or without food.

Cipralex MELTZ [Canadian product] should be dissolved on the tongue and swallowed without water.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Cipralex MELTZ [Canadian product] should be stored in original package and protected from light.

Recommended dose: 10 mg orally once a day

Use: Acute and maintenance treatment of major depressive disorder

Liver dysfunction: 10 mg orally once a day

Data not available

Administration advice:
-Doses may be administered in the morning or evening, without regard to food.
-10 and 20 mg oral tablets are scored and can be divided into equal doses.

General:
-Dosage should be adjusted based upon individual patient response.
-Use for extended periods of time should be periodically re-evaluated for long-term usefulness in each individual patient.
-This drug is indicated as an integral part of a total treatment program that may include other measures.
-The tablets and oral solution are considered bioequivalent.

Monitoring:
-Hepatic: Hepatic function
-Metabolic: Hyponatremia
-Nervous system: Serotonin syndrome
-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
-Renal: Renal function

Patient advice:
-This medicine may increase the risk of suicidal thoughts and behavior. Be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report any behavior of concern to your healthcare provider as soon as possible.
-Tell your healthcare provider about all of the medicines that you take, including prescription and non-prescription medicines.
-This medicine may impair judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.