Notice
[Posted 08/24/2011] ISSUE: FDA notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.
Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary at: http://www.fda.gov/Drugs/DrugSafety/ucm269086.htm for additional information.
BACKGROUND: Citalopram hydrobromide (Celexa) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).
RECOMMENDATION: Citalopram causes dose-dependent QT interval prolongation. Citalopram should no longer be prescribed at doses greater than 40 mg per day. Citalopram should not be used in patients with congenital long QT syndrome. Patients with congestive heart failure, bradyarrhythmias, or predisposition to hypokalemia or hypomagnesemia because of concomitant illness or drugs, are at higher risk of developing Torsade de Pointes. See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Warning
A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as citalopram during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take citalopram, but in some cases, a doctor may decide that citalopram is the best medication to treat a child's condition.
You should know that your mental health may change in unexpected ways when you take citalopram or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.
Your healthcare provider will want to see you often while you are taking citalopram, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.
The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with citalopram. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273.
No matter your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.
Why is this medication prescribed?
Citalopram is used to treat depression. Citalopram is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain that helps maintain mental balance.
How should this medicine be used?
Citalopram comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day with or without food. Take citalopram at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take citalopram exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may start you on a low dose of citalopram and gradually increase your dose, not more often than once a week.
It may take 1 to 4 weeks before you feel the full benefit of citalopram. Continue to take citalopram even if you feel well. If you suddenly stop taking citalopram, you may experience withdrawal symptoms such as mood changes,irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, and difficulty falling asleep or staying asleep. Do not stop taking citalopram without talking to your doctor. Your doctor will probably decrease your dose gradually.
Other uses for this medicine
Citalopram is also sometimes used to treat eating disorders, alcoholism, panic disorder (condition that causes sudden attacks of extreme fear with no apparent cause), premenstrual dysphoric disorder (a group of physical and emotional symptoms that occur before the menstrual period each month), and social phobia (excessive anxiety about interacting with others). Talk to your doctor about the possible risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking citalopram,
tell your doctor and pharmacist if you are allergic to citalopram, escitalopram (Lexapro), or any other medications.
tell your doctor if you are taking pimozide (Orap) or a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take citalopram. If you stop taking citalopram, you should wait at least 14 days before you start to take an MAO inhibitor.
you should know that citalopram is very similar to another SSRI, escitalopram (Lexapro). You should not take these two medications together.
tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); other antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); carbamazepine (Tegretol); cimetidine (Tagamet); ketoconazole (Nizoral); linezolid (Zyvox); lithium (Eskalith, Lithobid); medications for anxiety, mental illness, Parkinson's disease, and seizures; medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); metoprolol (Lopressor, Toprol XL); sedatives; sibutramine (Meridia); sleeping pills; tramadol (Ultram); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor what nutritional supplements and herbal products you are taking, especially products that contain St. John's wort or tryptophan.
tell your doctor if you have recently had a heart attack and if you have or have ever had seizures or liver, kidney, or heart disease.
tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking citalopram, call your doctor. Citalopram may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
you should know that citalopram may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
remember that alcohol can add to the drowsiness caused by this medication.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Citalopram may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience either of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
seeing things or hearing voices that do not exist (hallucinating)
fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
seizures
Citalopram may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
dizziness
sweating
nausea
vomiting
uncontrollable shaking of a part of the body
drowsiness
rapid, irregular, or pounding heartbeat
memory loss
confusion
seizures
coma
rapid breathing
