amniotic fluid are similar to those observed in maternal serum. There are risks of persistent pulmonary hypertension of the newborn (PPHN) and/or poor neonatal adaptation with exposure during pregnancy; there also are risks associated with untreated depression in pregnancy In animal reproduction studies, citalopram caused adverse embryo/fetal effects at doses that caused maternal toxicity Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum Neonates exposed to this drug late in 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 findings are consistent with either a direct toxic effect of SSRIs or possibly, a drug discontinuation syndrome; it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome Persistent pulmonary hypertension of the newborn Potential risk of PPHN 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 Presence of citalopram in human milk at relative infant doses ranging between 0.7 to 9.4% of maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.78 to 4.3 reported There are reports of breastfed infants exposed to this drug experiencing irritability, restlessness, excessive somnolence, decreased feeding, and weight loss There is no information about effects of this drug on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for this drug and any potential adverse effects on the breastfed child from this drug or from underlying maternal condition Monitor breastfeeding infants for adverse reactions, such as irritability, restlessness, excessive somnolence, decreased feeding, and weight lossPregnancy 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. Mechanism of Action Inhibits the reuptake of serotonin in presynaptic neurons; little or no affinity for dopamine, alpha-adrenergic histamine, or cholinergic receptor Absorption Bioavailability: 80% Peak serum time: 1-6 hr (4 hr average) Onset: 1-4 weeks for depression; full response may not be seen until 8-12 weeks after initiating treatment Distribution Protein bound: 80% Vd: 12 L/kg Metabolism Mainly via hepatic P450 enzymes CYP3A4 and CYP2C19 Metabolites: Insignificant potency Elimination Half-life: 24-48 hr Dialyzable: No Renal clearance: 66 mL/min Total body clearance: 330 mL/min Excretion: Urine (10%) BRAND FORM. UNIT PRICE PILL IMAGE citalopram oral- 20 mg tabletcitalopram oral- 10 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 10 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 10 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 10 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 10 mg/5 mL solutioncitalopram oral- 40 mg tabletcitalopram oral- 10 mg tabletcitalopram oral- 10 mg/5 mL solutioncitalopram oral- 10 mg tabletcitalopram oral- 10 mg/5 mL solutioncitalopram oral- 10 mg/5 mL solutioncitalopram oral- 30 mg capsulecitalopram oral- 40 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 40 mg tabletcitalopram oral- 20 mg tabletcitalopram oral- 10 mg tabletCelexa oral- 20 mg tabletCelexa oral- 10 mg tabletCelexa oral- 40 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationcitalopram oral CITALOPRAM - ORAL (sye-TAL-oh-pram) COMMON BRAND NAME(S): Celexa WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. USES: Citalopram is used to treat depression. It may improve your energy level and feelings of well-being. Citalopram is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain. HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking citalopram and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication with or without food as directed by your doctor, usually once daily in the morning or evening. The dosage is based on your medical condition, response to treatment, age, laboratory tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.To reduce your risk of side effects, your doctor may direct you to start taking this drug at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.It may take 1 to 4 weeks to feel a benefit from this drug and up to several weeks before you get the full benefit.Tell your doctor if your condition does not improve or if it worsens. SIDE EFFECTS: See also Warning and Precautions sections.Nausea, dry mouth, loss of appetite, tiredness, drowsiness, sweating, blurred vision, and yawning may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: shaking (tremor), decreased interest in sex, changes in sexual ability, easy bleeding/bruising.Get medical help right away if you have any very serious side effects, including: fainting, fast/irregular heartbeat, black stools, vomit that looks like coffee grounds, seizures, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.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 or at www.fda.gov/medwatch.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 citalopram, tell your doctor or pharmacist if you are allergic to it; or to escitalopram; 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 bipolar/manic-depressive disorder, personal or family history of suicide attempts, liver disease, seizures, low sodium in the blood, bleeding problems, personal or family history of glaucoma (angle-closure type).Citalopram may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using citalopram, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, recent heart attack, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using citalopram safely.This drug may make you drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).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 side effects of this drug, especially bleeding, loss of coordination, and QT prolongation (see above). They may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are also taking "water pills" (diuretics). Loss of coordination can increase the risk of falling.Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss.