Description
Escitalopram is used to treat depression and generalized anxiety disorder (GAD). It is an antidepressant that belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines work by increasing the activity of the chemical serotonin in the brain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Solution
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 younger than 7 years of age 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.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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 this medicine, 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 this medicine 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.
- Bepridil
- Bromopride
- Cisapride
- Clorgyline
- Dronedarone
- Fluconazole
- Isocarboxazid
- Lazabemide
- Levoketoconazole
- Linezolid
- Mesoridazine
- Methylene Blue
- Metoclopramide
- Nialamide
- Ozanimod
- Phenelzine
- Pimozide
- Piperaquine
- Procarbazine
- Rasagiline
- Safinamide
- Saquinavir
- Selegiline
- Sparfloxacin
- Terfenadine
- Tranylcypromine
- Ziprasidone
Using this medicine 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
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Apixaban
- Apomorphine
- Ardeparin
- Argatroban
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atomoxetine
- Azithromycin
- Bedaquiline
- Bemiparin
- Benzhydrocodone
- Benzphetamine
- Betrixaban
- Bivalirudin
- Bromfenac
- Brompheniramine
- Bufexamac
Using this medicine 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
- Ginkgo
- Lamotrigine
Other Interactions
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 this medicine. 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
- Kidney disease, severe or
- Mania, history of or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, mild to moderate or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
Escitalopram may be taken with or without food. If your doctor tells you to take it at a specific time, follow your doctor's instructions.
If you are using the oral liquid, shake the bottle well before measuring each dose. Use a marked measuring spoon, oral syringe, or medicine cup to measure each dose. The average household teaspoon may not hold the right amount of liquid.
You may have to take escitalopram for a month or longer before you begin to feel better.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (solution or tablets):
- For depression:
- Adults and children 12 years of age and older—10 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Older adults—10 mg once a day, taken either in the morning or evening.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For generalized anxiety disorder:
- Adults and children 7 years of age and older—At first, 10 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 20 mg per day.
- Older adults—10 mg once a day, taken either in the morning or evening.
- Children younger than 7 years of age—Use and dose must be determined by your doctor.
- For depression:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects. Blood tests may be needed to check for any unwanted effects.
Do not take escitalopram with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking escitalopram during the 14 days after you stop a MAO inhibitor. Wait 14 days after stopping escitalopram before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.
Do not take escitalopram with pimozide (Orap®). Using these medicines together can cause very serious heart problems.
Escitalopram may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Check with your doctor right away if you or your child have anxiety, change or loss of consciousness, confusion as to time, place, or person, diarrhea, dizziness, dry mouth, extremely high fever or body temperature, holding false beliefs that cannot be changed by fact, hyperventilation, increased sweating, irregular heartbeats, irritability, muscle cramps, muscle twitching or jerking, nausea, pale, clammy skin, nervousness, redness of the face, neck, arms and occasionally, upper chest, restless, rhythmic movement of muscles, seeing, hearing, or feeling things that are not there, shakiness in the legs, arms, hands, or feet, trembling or shaking of the hands or feet, trouble breathing, trouble sleeping, or vomiting. These may be symptoms of a serious condition called serotonin syndrome. The risk may be higher if you or your child also take certain other medicines that affect the serotonin levels in the body. Do not use escitalopram with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with escitalopram.
Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This will decrease the chance of having withdrawal symptoms such as increased anxiety, burning or tingling feelings, confusion, dizziness, headache, irritability, nausea, trouble sleeping, or unusual tiredness or weakness.
This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).
This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, headache, memory problems, trouble concentrating, weakness, or unsteadiness.
This medicine may cause some people to become drowsy, have trouble with thinking or controlling body movements. Make sure you know how you react to escitalopram before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.
The use of alcohol is not recommended in patients who are taking escitalopram.
Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Decreased interest in sexual intercourse
- delayed or inability to have an orgasm
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- not able to have an orgasm
Rare
- Coma
- confusion
- decreased urine output
- dizziness
- fast or irregular heartbeat
- headache
- increased thirst
- muscle pain or cramps
- nausea or vomiting
- seizures
- swelling of the face, ankles, or hands
- trouble breathing
- unusual tiredness or weakness
Incidence not known
- Bigger, dilated, or enlarged pupils (black part of the eye)
- black, tarry stools
- bloating
- blood in the urine
- bloody nose
- burning while urinating
- changes in skin color
- chest pain, discomfort, or tightness
- chills
- constipation
- cough
- dark-colored urine
- eye pain and blurred vision
- fainting
- fever
- heavier menstrual periods
- hives, itching, skin rash
- increased sensitivity of the eyes to light
- indigestion
- irregular or slow heart rate
- pain, redness, or swelling in the arm or leg
- pain or discomfort in the arms, jaw, back or neck
- pains in the stomach, side, or abdomen, possibly radiating to the back
- painful or difficult urination
- palpitations
- puffiness or swelling of the eyelids or around the eyes, face, lips
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain, continuing
- sweating
- swelling of the breasts or unusual milk production
- swelling of the foot or leg
- swollen or painful glands
- unusual bleeding or bruising
- vomiting of blood or material that looks like coffee grounds
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Diarrhea
- dry mouth
- heartburn
- sleepiness or unusual drowsiness
- trouble sleeping
Less common
- Bloated or full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased appetite
- excess air or gas in the stomach or bowels
- general feeling of discomfort or illness
- increased sweating
- joint pain
- muscle aches and pains
- pain in the neck or shoulders
- pain or tenderness around the eyes and cheekbones
- passing gas
- runny nose
- shivering
- sneezing
- stuffy nose
- tooth problems
- unusual dreams
- unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
- yawning
Incidence not known
- Blistering, peeling, loosening of the skin
- change in walking and balance
- clumsiness or unsteadiness
- decrease in smell
- hair loss or thinning of the hair
- increased sensitivity of skin to sunlight
- lack or loss of strength
- loss of sense of smell
- red irritated eyes
- red skin lesions, often with a purple center
- redness or other discoloration of the skin
- severe sunburn
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
