Citalopram Hydrobromide (Page 7 of 8)

Initial Treatment

Citalopram tablets (citalopram HBr) should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

Special Populations

20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see WARNINGS)

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram should be used with caution in patients with severe renal impairment.

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to citalopram and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with citalopram during the third trimester, the physician should carefully consider the potential risks and benefits of treatment.

Maintenance Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of citalopram in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of citalopram (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of citalopram 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered.

Discontinuation of Treatment with Citalopram

Symptoms associated with discontinuation of citalopram and other SSRIs and SNRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with citalopram. Conversely, at least 14 days should be allowed after stopping citalopram before starting an MAOI intended to treat psyachiatric disorders (see CONTRAINDICATIONS).

Use of citalopram with Other MAOIs, Such as Linezolid or Methylene Blue

Do not start citalopram in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving citalopram therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, citalopram should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with citalopram may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with citalopram is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

HOW SUPPLIED

Citalopram Tablets, USP 40 mg

NDC 12634-027-00 Bottles of 10

NDC 12634-027-01 Bottles of 100

NDC 12634-027-09 Bottles of 35

NDC 12634-027-40 Bottles of 40

NDC 12634-027-42 Bottles of 42

NDC 12634-027-50 Bottles of 50

NDC 12634-027-52 Blister Pack of 12

NDC 12634-027-54 Blister Pack of 14

NDC 12634-027-57 Blister Pack of 20

NDC 12634-027-59 Blister Pack of 30

NDC 12634-027-60 Bottles of 60

NDC 12634-027-61 Blister Pack of 10

NDC 12634-027-63 Blister Pack of 3

NDC 12634-027-66 Blister Pack of 6

NDC 12634-027-67 Blister pack of 7

NDC 12634-027-69 Blister Pack of 9

NDC 12634-027-71 Bottles of 30

NDC 12634-027-74 Bottles of 24

NDC 12634-027-78 Bottles of 28

NDC 12634-027-79 Bottles of 25

NDC 12634-027-80 Bottles of 20

NDC 12634-027-81 Bottles of 21

NDC 12634-027-82 Bottles of 12

NDC 12634-027-85 Bottles of 15

NDC 12634-027-91 Blister pack of 1

NDC 12634-027-94 Bottles of 4

NDC 12634-027-95 Bottles of 5

NDC 12634-027-96 Bottles of 6

Tan coloured, oval shaped, biconvex film coated tablets with ’4|0′ debossed (’4′ on left side and ’0′ on right side of the break line) on one side and ’1011′ on the other side.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

ANIMAL TOXICOLOGY

Retinal Changes in Rats

Pathologic changes (degeneration/atrophy) were observed in the retinas of albino rats in the 2-year carcinogenicity study with citalopram. There was an increase in both incidence and severity of retinal pathology in both male and female rats receiving 80 mg/kg/day (13 times the maximum recommended daily human dose of 60 mg on a mg/m 2 basis). Similar findings were not present in rats receiving 24 mg/kg/day for two years, in mice treated for 18 months at doses up to 240 mg/kg/day, or in dogs treated for one year at doses up to 20 mg/kg/day (4, 20, and 10 times, respectively, the maximum recommended daily human dose on a mg/m 2 basis).

Additional studies to investigate the mechanism for this pathology have not been performed, and the potential significance of this effect in humans has not been established.

Cardiovascular Changes in Dogs

In a one-year toxicology study, 5 of 10 beagle dogs receiving oral doses of 8 mg/kg/day (4 times the maximum recommended daily human dose of 60 mg on a mg/m 2 basis) died suddenly between weeks 17 and 31 following initiation of treatment. Although appropriate data from that study are not available to directly compare plasma levels of citalopram (CT) and its metabolites, demethylcitalopram (DCT) and didemethylcitalopram (DDCT), to levels that have been achieved in humans, pharmacokinetic data indicate that the relative dog-to-human exposure was greater for the metabolites than for citalopram. Sudden deaths were not observed in rats at doses up to 120 mg/kg/day, which produced plasma levels of CT, DCT, and DDCT similar to those observed in dogs at doses of 8 mg/kg/day. A subsequent intravenous dosing study demonstrated that in beagle dogs, DDCT caused QT prolongation, a known risk factor for the observed outcome in dogs. This effect occurred in dogs at doses producing peak DDCT plasma levels of 810 to 3250 nM (39-155 times the mean steady state DDCT plasma level measured at the maximum recommended human daily dose of 60 mg). In dogs, peak DDCT plasma concentrations are approximately equal to peak CT plasma concentrations, whereas in humans, steady state DDCT plasma concentrations are less than 10% of steady state CT plasma concentrations. Assays of DDCT plasma concentrations in 2020 citalopram-treated individuals demonstrated that DDCT levels rarely exceeded 70 nM; the highest measured level of DDCT in human overdose was 138 nM. While DDCT is ordinarily present in humans at lower levels than in dogs, it is unknown whether there are individuals who may achieve higher DDCT levels. The possibility that DCT, a principal metabolite in humans, may prolong the QT interval in dogs has not been directly examined because DCT is rapidly converted to DDCT in that species.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

Repackaged and Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

Medication Guide

Citalopram (si TAL o pram) Tablets, USP

Rx Only

Read the Medication Guide that comes with citalopram tablets 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 tablets are 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:

  • chest pain
  • fast or slow heartbeat
  • shortness of breath
  • dizziness or fainting

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

  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity

4. Severe allergic reactions:

  • trouble breathing
  • swelling of the face, tongue, eyes or mouth
  • rash, itchy welts (hives) or blisters, alone or with fever or joint pain

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, 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

Do not stop citalopram tablets without first talking to your healthcare provider. Stopping citalopram tablets 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

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.

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 tablets 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 tablets. See the end of this Medication Guide for a complete list of ingredients in citalopram tablets.
  • If you 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 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, 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 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 oxalateincluding: Lexapro.

How should I take citalopram tablets?

  • 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 affect you. Do not drink alcohol while using citalopram tablets.

What are the possible side effects of citalopram tablet?

Citalopram tablets 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:

  • Nausea
  • Sleepiness
  • Weakness
  • Dizziness
  • Feeling anxious
  • Trouble sleeping
  • Sexual problems
  • Sweating
  • Shaking
  • Not feeling hungry
  • Dry mouth
  • Constipation
  • Diarrhea
  • Respiratory Infections
  • Yawning

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 at 20º-25°C (68º-77°F); excursions permitted to 15°-30°C (59º-86°F) [see USP Controlled Room Temperature].
  • 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 1-269-544-2299.

What are the ingredients in citalopram tablets ?

Active ingredient: citalopram hydrobromide, USP

Inactive ingredients:

  • Tablets: copovidone, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch, and titanium dioxide.

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

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

Repackaged and Distributed by:

Apotheca Inc.

Phoenix, AZ 85006

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