CITALOPRAM HYDROBROMIDE CITALOPRAM

Get an overview of CITALOPRAM HYDROBROMIDE (citalopram tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in CITALOPRAM HYDROBROMIDE can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as CITALOPRAM HYDROBROMIDE.

Drug Basics

Brand Name: CITALOPRAM HYDROBROMIDE

Generic Name: CITALOPRAM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2018-10-05

indications & usage

Citalopram tablets, USP are indicated for the treatment of depression.

The efficacy of citalopram in the treatment of depression was established in 4 to 6 week; controlled trials of outpatients whose diagnosis corresponded most closely to the DSM-III and DSM-III-R category of major depressive disorder (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. The antidepressant action of citalopram tablets, USP in hospitalized depressed patients has not been adequately studied.

The efficacy of citalopram in maintaining an antidepressant response for up to 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use citalopram for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

contraindications

The use of MAOIs intended to treat psychiatric disorders with citalopram or within 14 days of stopping treatment with citalopram is contraindicated because of an increased risk of serotonin syndrome. The use of citalopram within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE and ADMINISTRATION).

Starting citalopram in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION).

Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).
Citalopram is contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in citalopram.

drug abuse & dependence

controlled substance class

Citalopram HBr is not a controlled substance.

physical & psychological dependence

Animal studies suggest that the abuse liability of citalopram is low. Citalopram has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. The premarketing clinical experience with citalopram did not reveal any drug-seeking behavior. However, these observations were not systematic and it is not possible to predict, on the basis of this limited experience, the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate citalopram patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (e.g., development of tolerance, incrementations of dose, drug-seeking behavior).

                                                                                                              medication guide                                                                                                       citalopram tablets, usp                                                                                                             (sih-tal-oh-pram)

Read the Medication Guide that comes with citalopram before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

What is the most important information I should know about citalopram tablets?

Citalopram tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

  • Citalopram tablets and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
     
    •  New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when citalopram is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

  • attempts to commit suicide
  • acting on dangerous impulses
  • acting aggressive or violent
  • thoughts about suicide or dying
  • new or worse depression
  • new or worse anxiety or panic attacks
  • feeling agitated, restless, angry or irritable
  • trouble sleeping
  • an increase in activity or talking more than what is normal for you
  • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Citalopram tablets may be associated with these serious side effects:

2. Changes in the electrical activity of your heart (QT prolongation and Torsade de Pointes).

This condition can be life threatening. The symptoms may include:

3. Serotonin Syndrome. This condition can be life-threatening and may include:

4. Severe allergic reactions:

5. Abnormal bleeding: Citalopram tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

6. Seizures or convulsions

7. Manic episodes:

  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

8. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems

10. Visual problems

  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Do not stop citalopram without first talking to your healthcare provider. Stopping citalopram too quickly may cause serious symptoms including:

  • anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
  • headache, sweating, nausea, dizziness
  • electric shock-like sensations, shaking, confusion

What are citalopram tablets?

Citalopram tablets are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Citalopram tablets are also used to treat:

  • Major Depressive Disorder (MDD)

Talk to your healthcare provider if you do not think that your condition is getting better with citalopram treatment.

Who should not take citalopram tablets?

Do not take citalopram tablets if you:

  • are allergic to citalopram hydrobromide or escitalopram oxalate or any of the ingredients in citalopram. See the end of this Medication Guide for a complete list of ingredients in citalopram tablets.
  • take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 2 weeks of stopping citalopram tablets unless directed to do so by your physician.
  • Do not start citalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take citalopram tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
  • take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
  • have a heart problem including congenital long QT syndrome.

What should I tell my healthcare provider before taking citalopram tablets? Ask if you are not sure.

Before starting citalopram tablets, tell your healthcare provider if you

  • Are taking certain drugs such as:
    • Medicines for heart problems
    • Medicines that lower your potassium or magnesium levels in your body
    • Cimetidine
    • Triptans used to treat migraine headache
    • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, amphetamines, or antipsychotics
    • Tramadol
    • Over-the-counter supplements such as tryptophan or St. John’s Wort
  • have liver problems
  • have kidney problems
  • have heart problems
  • have or had seizures or convulsions
  • have bipolar disorder or mania
  • have low sodium levels in your blood
  • have a history of a stroke
  • have high blood pressure
  • have or had bleeding problems
  • are pregnant or plan to become pregnant. It is not known if citalopram tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks  of treating depression during pregnancy.
  • are breast feeding or plan to breast-feed. Some citalopram hydrobromide may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking citalopram tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Citalopram tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take citalopram tablets with your other medicines. Do not start or stop any medicine while taking citalopram tablets without talking to your healthcare provider first.

If you take citalopram tablets, you should not take any other medicines that contain citalopram hydrobromide or escitalopram oxalate including: Lexapro®.

How should I take citalopram?

  • Take citalopram tablets exactly as prescribed. Your healthcare provider may need to change the dose of citalopram tablets until it is the right dose for you.
  • Citalopram tablets may be taken with or without food.
  • If you miss a dose of citalopram tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of citalopram tablets at the same time.
  • If you take too much citalopram tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking citalopram tablets?

Citalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how citalopram tablets affects you. Do not drink alcohol while using citalopram tablets.

What are the possible side effects of citalopram tablets?

Citalopram may cause serious side effects, including:

See “What is the most important information I should know about citalopram tablets?”

Common possible side effects in people who take citalopram tablets include:

Other side effects in children and adolescents include:

  • increased thirst
  • abnormal increase in muscle movement or agitation
  • nose bleed
  • urinating more often
  • heavy menstrual periods
  • possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with citalopram tablets.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of citalopram tablets. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store citalopram tablets?

  • Store citalopram tablets at 20° to 25°C (68°F to 77°F)
  • Keep citalopram tablets bottle closed tightly.

Keep citalopram tablets and all medicines out of the reach of children.

General information about citalopram tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use citalopram tablets for a condition for which it was not prescribed. Do not give citalopram tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about citalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about citalopram tablets that is written for healthcare professionals.

For more information about citalopram tablets call Exelan Pharmaceutical, Inc. at 1-855-295-7455 or go to www.exelanpharma.com.

What are the ingredients in citalopram tablets, USP?

Active ingredient: citalopram hydrobromide, USP

Inactive ingredients: copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, opadry beige (HPMC 2910/hypromellose 6cp, titanium dioxide, macrogol/ Peg400, iron oxide yellow and iron oxide red), opadry pink (HPMC 2910/hypromellose 6cP, titanium dioxide, macrogol/Peg400 and iron oxide red) and opadry white (titanium dioxide, HPMC 2910/hypromellose 3cp, HPMC 2910/hypromellose 6cp, Macrogol/Peg400 and Polysorbate 80) are used as coating agents in the beige (10 mg), pink (20 mg) and white (40 mg) tablets.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Exelan Pharmaceuticals, Inc.

Manufactured by:

InvaGen Pharmaceuticals, Inc.

Hauppauge, NY 11788

Manufactured for:

Exelan Pharmaceuticals, Inc.

Lawrenceville, GA 30046

Revised: 06/2017

Principal Display Panel – 20 mg Bottle Label

NDC 43353-208-15

Citalopram Tablets, USP

20 mg*

Rx only        15 Tablets

43353 208 15.jpg

Principal Display Panel – 40 mg Bottle Label

NDC 43353-112-15

Citalopram Tablets, USP

40 mg*

Rx only        15 Tablets

43353 112 15.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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