Brand Name

    US Brand Name

    CeleXA


    Description

    Citalopram is used to treat depression, including major depressive disorder (MDD). It is an antidepressant that belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called 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
    • Capsule

    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 have not been performed on the relationship of age to the effects of citalopram in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Citalopram capsules is not recommended for use in the elderly because an adjustment in the dose is not possible with the available dose strength of this medicine.

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

    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
    • Dronedarone
    • Fluconazole
    • Isocarboxazid
    • Ketoconazole
    • Levoketoconazole
    • Linezolid
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Nelfinavir
    • Ozanimod
    • Phenelzine
    • Pimozide
    • Piperaquine
    • Posaconazole
    • Procarbazine
    • Rasagiline
    • Safinamide
    • Selegiline
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • 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
    • Armodafinil
    • Arsenic Trioxide
    • Artemether
    • Asenapine
    • Aspirin
    • Astemizole
    • Atazanavir
    • Azithromycin
    • Bedaquiline
    • Bemiparin
    • Benzhydrocodone
    • Benzphetamine
    • Betrixaban
    • Bivalirudin
    • Bromfenac
    • Brompheniramine

    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.

    • Ginkgo
    • Irinotecan
    • Rifampin

    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
    • Mania, history of or
    • Seizures, history of—Use with caution. May make these conditions worse.
    • Bradycardia (slow heart rate) or
    • Heart attack, recent or
    • Heart failure or
    • Heart rhythm problems (eg, congenital long QT syndrome) or
    • Hypokalemia (low potassium in the blood) or
    • Hypomagnesemia (low magnesium in the blood)—Use with caution. May cause side effects to become 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.

    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.

    Citalopram 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 citalopram 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 (capsules):
      • For depression:
        • Adults—30 milligrams (mg) once a day. Your doctor may adjust your dose as needed. Do not start treatment with citalopram capsules because the only available dose strength is 30 mg. Use another dosage form of citalopram (eg, solution or tablets) for starting treatment and adjusting doses other than 30 mg once a day.
        • Older adults—Use is not recommended.
        • Children—Use and dose must be determined by your doctor.
    • For oral dosage forms (solution or tablets):
      • For depression:
        • Adults—At first, 20 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 40 mg per day.
        • Older adults—20 mg once a day, taken either in the morning or evening.
        • Children—Use and dose must be determined by your doctor.

    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 unwanted effects.

    Do not take citalopram with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid (Zyvox®), methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking citalopram during the 14 days after you stop a MAO inhibitor. Wait 14 days after stopping citalopram before you start taking a MAO inhibitor. If you take them together or do not the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

    Do not take pimozide (Orap®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.

    Citalopram may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use citalopram with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), methylene blue injection, 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 citalopram.

    Citalopram 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.

    Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or irregular heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem including QT prolongation or slow heartbeat.

    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 using before stopping it completely. This will decrease the chance of having withdrawal symptoms including agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

    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 feel unsteady when standing.

    The use of alcohol is not recommended in patients who are taking this medicine.

    This medicine may cause some people to become drowsy, have trouble thinking, or to have problems with movement. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

    Your doctor may want to monitor your child's weight and height, because this medicine may cause decreased appetite and weight loss in children.

    Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have and 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:

    More common

    • Change or problem with discharge of semen

    Less common

    • Agitation
    • blurred vision
    • confusion
    • decreased interest in sexual intercourse
    • fever
    • inability to have or keep an erection
    • increase in the frequency of urination or amount of urine produced
    • lack of emotion
    • loss in sexual ability, desire, drive, or performance
    • loss of memory
    • menstrual changes
    • skin rash or itching
    • trouble breathing

    Rare

    • Behavior change similar to drunkenness
    • bleeding gums
    • breast tenderness or enlargement or unusual secretion of milk (in females)
    • chills
    • delayed or inability to have an orgasm
    • diarrhea
    • difficulty with concentrating
    • dizziness or fainting
    • drowsiness
    • increased hunger
    • increased thirst
    • irregular heartbeat
    • lack of energy
    • lethargy
    • nosebleed
    • overactive reflexes
    • painful urination
    • poor coordination
    • purple or red spots on the skin
    • rapid weight gain
    • red or irritated eyes
    • redness, tenderness, itching, burning, or peeling of the skin
    • seizures
    • shivering
    • slow or irregular heartbeat (less than 50 beats per minute)
    • sore throat
    • stupor
    • sweating
    • swelling of the face, ankles, or hands
    • talking or acting with excitement you cannot control
    • trembling, shaking, or twitching
    • trouble with holding or releasing urine
    • unusual or sudden body or facial movements or postures
    • unusual tiredness or weakness

    Incidence not known

    • Back or leg pains
    • black, tarry stools
    • blistering, peeling, or loosening of the skin
    • bloating
    • bloody stools
    • chest pain or tightness
    • confusion as to time, place, or person
    • constipation
    • cough
    • darkened urine
    • difficult or fast breathing
    • difficulty with swallowing
    • drooling
    • fast, slow, or irregular heartbeat
    • general body swelling
    • hive-like swelling on the face, eyelids, lips, tongue, or throat
    • hives, itching
    • holding false beliefs that cannot be changed by fact
    • impaired consciousness, ranging from confusion to coma
    • indigestion
    • joint or muscle pain
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • loss of appetite
    • loss of bladder control
    • loss of consciousness
    • muscle cramps, spasms, tightness, twitching, or jerking
    • painful or prolonged erection of the penis
    • pale skin
    • penile erections, frequent or continuing
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • recurrent fainting
    • red skin lesions, often with a purple center
    • rhythmic movement of the muscles
    • seeing, hearing, or feeling things that are not there
    • sores, ulcers, or white spots in the mouth or on the lips
    • stomach pain
    • swelling of the breasts or unusual milk production
    • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
    • total body jerking
    • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
    • uncontrolled jerking or twisting movements
    • unusual excitement
    • vomiting of blood or material that looks like coffee grounds
    • yellowing of the 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

    • Decrease in sexual desire or ability
    • sleepiness or unusual drowsiness

    Less common

    • Body aches or pain
    • change in sense of taste
    • continuing ringing or buzzing or other unexplained noise in the ears
    • gas
    • headache (severe and throbbing)
    • hearing loss
    • heartburn
    • increased sweating
    • increased yawning
    • loss of voice
    • loss or thinning of the hair
    • sneezing
    • stuffy or runny nose
    • tingling, burning, or prickly feelings on the skin
    • tooth grinding
    • unusual increase or decrease in weight
    • watering of the mouth

    Rare

    • Increased hair growth on the forehead, back, arms, and legs
    • tanning or blue-gray discoloration of the skin

    Incidence not known

    • Bruising
    • decrease in smell
    • inability to sit still
    • large, flat, blue or purplish patches in the skin
    • loss of sense of smell
    • need to keep moving
    • uncontrolled eye movements

    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.






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