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Celexa is excreted in human milk. Side effects have been reported in two nursing infants. The manufacturer recommends that a decision should be made to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

One study has reported that the relative dose to a suckling infant is similar to that reported for fluoxetine, and higher than that reported for fluvoxamine, paroxetine, or sertraline. Two cases have been reported of infants experiencing excessive somnolence, decreased feeding, and weight loss in relation to breast-feeding from a mother receiving Celexa. Milk/serum concentration ratios based on single pairs of samples from the two patients ranged from 1.16 to 1.88. Based on this, the absolute dose a suckling infant may ingest would be in the range of 4.3 to 17.6 micrograms/kg. The relative dose would be 0.7% to 5.9% of the weight- adjusted maternal dose. In one case the infant was reported to have recovered completely once the infant’s mother discontinued the Celexa. According to another case report, the relative infant Celexa dose from breast milk is approximately 9% of the weight- adjusted maternal dose. A study of seven women taking Celexa and their infants has reported that the plasma concentrations of Celexa and demethylCelexa in the infants were very low or absent and there were no adverse effects.

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A possible case of Celexa- induced withdrawal effects has been described in an infant which began within the first few days following delivery. Symptoms included apneas, superficial breathing, sleep disorders, and hypotonia which changed to hypertonia before all symptoms gradually subsided and completely disappeared after 3 weeks. The 33- year- old mother had received Celexa 40 mg daily throughout the pregnancy. The results of a cohort study indicate that 30% of neonates who had prolonged exposure to SSRIs in utero experience symptoms, in a dose- response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high- pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth.

Celexa has been assigned to pregnancy category C by the FDA. Celexa and its metabolites have been shown to cross the placenta. Human spontaneous abortion has been reported by the manufacturer. Neonates exposed to Celexa (and other SSRIs and SNRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. (Such complications can arise immediately upon delivery.) Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. (These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome.) In some cases, the clinical picture is consistent with serotonin syndrome. The results of a prospective comparative study (n=396 pregnant women) indicate that Celexa use during embryogenesis is not associated with an apparent major teratogenic risk in humans. However, Celexa should be given during pregnancy and particularly during the third trimester, only if the potential benefits outweigh the potential risks to the fetus.

Celexa may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Celexa while you are pregnant. Celexa is found in breast milk. Do not breast-feed while taking Celexa.

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Along with its needed effects, Celexa 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:

Celexa More common side effects
* Decrease in sexual desire or ability

Celexa Less common side effects
* Agitation
* blurred vision
* confusion
* fever
* increase in frequency of urination or amount of urine produced
* lack of emotion
* loss of memory
* menstrual changes
* skin rash or itching
* trouble in breathing

Celexa Rare side effects
* Anxiety
* behavior change similar to drunkenness
* bleeding gums
* breast tenderness or enlargement or unusual secretion of milk (in females)
* difficulty with concentrating
* dizziness or fainting
* increased hunger
* irregular heartbeat
* irritability
* lethargy
* low blood sodium (confusion, convulsions [seizures], drowsiness, dryness of mouth, increased thirst, or lack of energy)
* mood or mental changes
* nervousness
* nose bleed
* painful urination
* purple or red spots on skin
* sore throat, fever, and chills
* rapid weight gain
* red or irritated eyes
* redness, tenderness, itching, burning, or peeling of skin
* seizures
* serotonin syndrome (agitation, confusion, diarrhea, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, talking or acting with excitement you cannot control, trembling or shaking, or twitching)
* shakiness
* slow or irregular heartbeat (less than 50 beats per minute)
* stupor
* swelling of the face, ankles, or hands
* trouble with holding or releasing urine
* unusual or sudden body or facial movements or postures
* unusual tiredness or weakness

Celexa Incidence not known side effects
* Abdominal or stomach pain
* back or leg pains
* black, tarry stools
* bleeding gums
* bloating
* bloody stools
* chest pain
* confusion as to time, place, or person
* constipation
* cough
* darkened urine
* difficult or fast breathing
* difficulty swallowing
* drooling
* fast, slow, or irregular heartbeat
* fatigue
* general body swelling
* hallucinations
* hive-like swelling on the face, eyelids, lips, tongue, or throat
* hives
* holding false beliefs that cannot be changed by fact
* impaired consciousness, ranging from confusion to coma
* indigestion
* itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
* loss of appetite
* loss of bladder control
* loss of consciousness
* muscle cramps or spasms
* muscle tightness
* muscle twitching or jerking
* nervousness
* nosebleeds
* pale skin
* penile erections, frequent or continuing
* recurrent fainting
* redness, tenderness, itching, burning, or peeling of skin
* restlessness or agitation
* rhythmic movement of muscles
* shortness of breath
* skin rash
* swelling of breasts or unusual milk production
* tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over affected area
* tightness in chest
* total body jerking
* twitching, twisting, uncontrolled repetitive movements of tongue, lips, face, arms, or legs
* uncontrolled jerking or twisting movements
* unusual excitement
* vomiting of blood or material that looks like coffee grounds
* wheezing
* yellowing of the eyes or skin

Celexa Symptoms of overdose
* Bluish colored skin or lips
* confusion
* convulsions (seizures)
* coma
* deep or fast breathing with dizziness
* dizziness
* drowsiness
* fainting
* fast heartbeat
* general feeling of discomfort or illness
* loss of memory
* muscle pain
* nausea
* sleepiness
* slow or irregular heartbeat
* sweating
* trembling or shaking
* vomiting
* weakness

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:

Celexa More common side effects
* Drowsiness
* dry mouth
* nausea
* sleepiness or unusual drowsiness
* trouble in sleeping

Celexa Less common side effects
* Abdominal pain
* anxiety
* body aches or pain
* change in sense of taste
* chills
* diarrhea
* difficulty with breathing
* gas
* headache
* headache (severe and throbbing)
* heartburn
* increased sweating
* increased yawning
* loss of appetite
* loss of voice
* nasal congestion
* pain in muscles or joints
* sneezing
* sore throat
* stuffy or runny nose
* tingling, burning, or prickly feelings on skin
* tooth grinding
* trembling or shaking
* unusual increase or decrease in weight
* unusual tiredness or weakness
* vomiting
* watering of mouth

Celexa Incidence not known side effects
* Bruising
* inability to sit still
* large, flat, blue or purplish patches in the skin
* need to keep moving
* restlessness
* uncontrolled eye movements

After you stop using Celexa, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
* Anxiety
* dizziness
* nervousness
* trembling or shaking

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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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 .

Do not take Celexa with or within 14 days of taking an MAO inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], procarbazine [Matulane®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not take an MAO inhibitor within 14 days of taking Celexa. If you do, you may have extremely high blood pressure or convulsions (seizures) .

Make sure your doctor knows about all the other medicines you are using. Celexa may cause a serious condition called serotonin syndrome when taken with some medicines. Do not use Celexa with linezolid (e.g., Zyvox®), lithium, tryptophan, St. John’s Wort, or some pain or migraine medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines, including pimozide (Orap®) .

Celexa may cause some people 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. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child’s doctor right away .

Avoid drinking alcoholic beverages while you are taking Celexa .

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

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Take Celexa 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 .

Celexa 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 form of Celexa, shake the bottle well before measuring each dose. Use a marked measuring spoon, oral syringe or medicine cup to measure each dose .

You may have to take Celexa for 4 weeks before you begin to feel better. Your doctor will check your progress at regular visits during this time. Also, you may need to keep taking Celexa for 6 months or longer to help prevent the return of the depression .

Do not stop taking Celexa without checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely to prevent side effects .

Celexa Dosing
The dose of Celexa 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 Celexa that you take depends on the strength of Celexa. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take Celexa depend on the medical problem for which you are using Celexa.

* For oral dosage form (solution and tablets):
o For depression:
+ Adults and adolescents—At first, 20 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 60 mg a day.
+ Children—Use and dose must be determined by your doctor.
+ Older adults—At first, 20 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may increase your dose gradually if needed. However, the dose usually is not more than 40 mg a day .

Celexa Missed Dose
If you miss a dose of Celexa, 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.

Celexa Storage
Store Celexa 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.

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Celexa is used to treat mental depression .

Celexa belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical serotonin in the brain .

Celexa is available only with your doctor’s prescription.

Commonly used brand name(s):

In the U.S.
* Celexa

Celexa Available Dosage Forms:
* Tablet
* Solution

Celexa Therapeutic Class: Antidepressant
Celexa Pharmacologic Class: Serotonin Reuptake Inhibitor

Oral routeTabletSolution

* 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 citalopram hydrobromide 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. Citalopram hydrobromide is not approved for use in pediatric patients.

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients.

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Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

* Symptoms of Celexa overdose may include:
Amnesia, bluish or purplish discoloration of the skin, coma, confusion, convulsions, dizziness, drowsiness, hyperventilation, nausea, rapid heartbeat, sweating, tremor, vomiting

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ADULTS

The recommended starting dose of Celexa tablets or oral solution is 20 milligrams once a day. Dosage is usually increased to 40 milligrams once daily after at least a week has passed. Do not exceed 40 milligrams a day.

For older adults and those who have liver problems, the recommended dose is 20 milligrams once a day.

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The effects of Celexa during pregnancy have not been adequately studied, and the potential for harm has not been ruled out. If you are pregnant or plan to become pregnant while on Celexa therapy, tell your doctor immediately.

Celexa appears in breast milk and will affect the nursing infant. You should consider discontinuing either breastfeeding or Celexa. Talk with your doctor about the pros and cons of each option.

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Celexa does not increase the effects of alcohol. Nevertheless, it’s considered unwise to combine Celexa with alcohol or any other drug that affects the brain. (Be particularly careful to avoid MAO inhibitors.)

If Celexa is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Tell your doctor about any prescription or over-the-counter drugs you are planning to take, and be especially certain to check with him before combining Celexa with the following:

Carbamazepine
Cimetidine
Erythromycin
Fluconazole
Itraconazole
Ketoconazole
Lithium
Metoprolol
Omeprazole
Other antidepressants such as amitriptyline, desipramine, imipramine, and nortriptyline
Sumatriptan
Warfarin

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