Citalopram Hydrobromide (Page 10 of 10)

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/m2 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/m2 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/m2 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.

Rx Only

Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA

Revised: 0113

Medication Guide

CITALOPRAM TABLETS USP

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 somechildren, teenagers, or young adultswithin 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.
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 (Coumadin® , Jantoven®), a non-steroidal antiinflammatory 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 shouldhave height and weight monitoredduring treatment.

9. Low salt (sodium) levels in the blood. Elderly people may be atgreater risk for this.

Symptoms mayinclude:

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

What is citalopram tablets?

Citalopram tablets is 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.
Do not take an MAOI within 2 weeks of stopping citalopram tablets unless 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

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 maniahave low sodium levels in your blood
have a history of a strokehave 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 breastfeed. Some citalopram tablets 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 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 affects you. Do not drink alcohol while using citalopram tablets.

What are the possible side effects of citalopram tablets?

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 citalopram tablets at 20°-25°C (68°-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 1-888-375-3784.

What are the ingredients in citalopram tablets?

Active ingredient: citalopram hydrobromide

Inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, hypromellose 5 cP, hypromellose 6 cP, 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.

To reorder additional Medication Guides, contact Dr. Reddy’s customer service at 1-866-733-3952

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally — 500 090 INDIA

Revised: 0113

40 mg Container Label

Citalopram 40mg Tablets w/insert #15
(click image for full-size original)
CITALOPRAM HYDROBROMIDE
citalopram hydrobromide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-353(NDC:55111-344)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Citalopram hydrobromide (Citalopram) Citalopram 40 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
Copovidone K25-31
croscarmellose sodium
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
polyethylene glycol 400
starch, corn
titanium dioxide
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code RDY;344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-353-15 15 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077038 10/28/2004
Labeler — MedVantx, Inc. (806427725)
Registrant — Dr. Reddy’s Laboratories Limited (650562841)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-353)

Revised: 01/2013 MedVantx, Inc.

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