CITALOPRAM- citalopram hydrobromide solution

Citalopram by

Drug Labeling and Warnings

Citalopram by is a Prescription medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc., Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Other Events Observed During the Postmarketing Evaluation of Citalopram Hydrobromide

It is estimated that over 30 million patients have been treated with citalopram since market introduction. Although no causal relationship to citalopram treatment has been found, the following adverse events have been reported to be temporally associated with citalopram treatment, and have not been described elsewhere in labeling: acute renal failure, akathisia, allergic reaction, anaphylaxis, angioedema, choreoathetosis, chest pain, delirium, dyskinesia, ecchymosis, epidermal necrolysis, erythema multiforme, gastrointestinal hemorrhage, angle closure glaucoma, grand mal convulsions, hemolytic anemia, hepatic necrosis, myoclonus, nystagmus, pancreatitis, priapism, prolactinemia, prothrombin decreased, QT prolonged, rhabdomyolysis, spontaneous abortion, thrombocytopenia, thrombosis, ventricular arrhythmia, torsade de pointes, and withdrawal syndrome.

  • DRUG ABUSE AND DEPENDENCE

    Controlled Substance Class

    Citalopram Hydrobromide is not a controlled substance.

    Physical and 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).

  • OVERDOSAGE

    Human Experience

    In clinical trials of citalopram, there were reports of citalopram overdose, including overdoses of up to 2000 mg, with no associated fatalities. During the postmarketing evaluation of citalopram, citalopram overdoses, including overdoses of up to 6000 mg, have been reported. As with other SSRIs, a fatal outcome in a patient who has taken an overdose of citalopram has been rarely reported.

    Symptoms most often accompanying citalopram overdose, alone or in combination with other drugs and/or alcohol, included dizziness, sweating, nausea, vomiting, tremor, somnolence, and sinus tachycardia. In more rare cases, observed symptoms included amnesia, confusion, coma, convulsions, hyperventilation, cyanosis, rhabdomyolysis, and ECG changes (including QTc prolongation, nodal rhythm, ventricular arrhythmia, and very rare cases of torsade de pointes). Acute renal failure has been very rarely reported accompanying overdose.

    Management of Overdose

    Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric evacuation by lavage and use of activated charcoal should be considered. Careful observation and cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive care. Due to the large volume of distribution of citalopram, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. There are no specific antidotes for citalopram.

    In managing overdosage, consider the possibility of multiple-drug involvement. The physician should consider contacting a poison control center for additional information on the treatment of any overdose.

  • DOSAGE AND ADMINISTRATION

    Citalopram Oral Solution, USP should be administered once daily, in the morning or evening, with or without food.

    Initial Treatment

    Citalopram Oral Solution, USP 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 Oral Solution, USP should be used with caution in patients with severe renal impairment.

    Treatment of Pregnant Women During the Third Trimester

    Neonates exposed to Citalopram Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP (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 Oral Solution, USP 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 Oral Solution, USP

    Symptoms associated with discontinuation of Citalopram Oral Solution, USP 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 Oral Solution, USP. Conversely, at least 14 days should be allowed after stopping Citalopram Oral Solution, USP before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

    Use of Citalopram Oral Solution, USP with Other MAOIs, Such as Linezolid or Methylene Blue

    Do not start Citalopram Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 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 Oral Solution, USP 10 mg/5 mL, peppermint flavor is supplied as:

    NDC: 0121-0848-05: 5 mL unit dose cup
    NDC: 0121-0848-40: Case contains 40 unit dose cups of 5 mL (0121-0848-05) packaged in 4 trays of 10 unit dose cups each.

    NDC: 0121-1696-10: 10 mL unit dose cup
    NDC: 0121-1696-40: Case contains 40 unit dose cups of 10 mL (0121-1696-10) packaged in 4 trays of 10 unit dose cups each.

    Store at 20° - 25°C (68° - 77ºF). [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 2,020 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.

  • SPL UNCLASSIFIED SECTION

    PACKAGED BY

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605
    www.paipharma.com

    R01/19

  • Medication Guide

    Citalopram (sye tal' oh pram) Oral Solution, USP

    Read the Medication Guide that comes with Citalopram Oral Solution 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 Oral Solution?

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

    1. Suicidal thoughts or actions:

    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:

    Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Citalopram Oral Solution 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 Oral Solution 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:

    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:

    10. Visual problems.

    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 Oral Solution without first talking to your healthcare provider.

    Stopping Citalopram Oral Solution too quickly may cause serious symptoms including:

    What is Citalopram Oral Solution?

    Citalopram Oral Solution 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 Oral Solution is also used to treat:

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

    Who should not take Citalopram Oral Solution?

    Do not take Citalopram Oral Solution if you:

    People who take Citalopram Oral Solution 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:

    What should I tell my healthcare provider before taking Citalopram Oral Solution? Ask if you are not sure.

    Before starting Citalopram Oral Solution, tell your healthcare provider if you

    Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Citalopram Oral Solution 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 Oral Solution with your other medicines. Do not start or stop any medicine while taking Citalopram Oral Solution without talking to your healthcare provider first.

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

    How should I take Citalopram Oral Solution?

    What should I avoid while taking Citalopram Oral Solution?

    Citalopram Oral Solution 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 Oral Solution affects you. Do not drink alcohol while using Citalopram Oral Solution.

    What are the possible side effects of Citalopram Oral Solution? Citalopram Oral Solution may cause serious side effects, including:

    See " What is the most important information I should know about Citalopram Oral Solution?"

    Common possible side effects in people who take Citalopram Oral Solution include:

    Other side effects in children and adolescents include:

    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 Oral Solution. 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 Oral Solution?

    Keep Citalopram Oral Solution and all medicines out of the reach of children.

    General information about Citalopram Oral Solution

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

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

    For more information about Citalopram Oral Solution call 1-800-845-8210.

    What are the ingredients in Citalopram Oral Solution?

    Active ingredient: citalopram hydrobromide

    Inactive ingredients: sorbitol, purified water, propylene glycol, methylparaben, peppermint flavor, propylparaben.

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

    Trademarks are the property of their respective owners.

    PACKAGED BY

    Pharmaceutical
    Associates, Inc.

    Greenville, SC 29605
    www.paipharma.com

    R01/19

  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    Delivers 5 mL
    NDC: 0121-0848-05

    Citalopram
    Oral Solution, USP

    10 mg/5 mL

    Equivalent to 2 mg citalopram per mL

    FOR INSTITUTIONAL USE ONLY
    RX ONLY

    Pkg. by: Pharmaceutical Associates, Inc.
    Greenville, SC 29605

    SEE INSERT

    A0848050119

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
  • PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

    Delivers 10 mL
    NDC: 0121-1696-10

    Citalopram
    Oral Solution, USP

    20 mg/10 mL

    Equivalent to 2 mg citalopram per mL

    FOR INSTITUTIONAL USE ONLY
    RX ONLY

    Pkg. by: Pharmaceutical Associates, Inc.
    Greenville, SC 29605

    SEE INSERT

    A0848100119

    PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
  • INGREDIENTS AND APPEARANCE
    CITALOPRAM 
    citalopram hydrobromide solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0121-0848(NDC:54838-540)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V) CITALOPRAM10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0121-0848-404 in 1 CASE04/08/2019
    110 in 1 TRAY
    1NDC: 0121-0848-055 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762906/14/2006
    CITALOPRAM 
    citalopram hydrobromide solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0121-1696
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V) CITALOPRAM20 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0121-1696-404 in 1 CASE04/08/2019
    110 in 1 TRAY
    1NDC: 0121-1696-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07762904/08/2019
    Labeler - Pharmaceutical Associates, Inc. (044940096)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaceutical Associates, Inc.097630693repack(0121-0848, 0121-1696)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lannett Company, Inc.161630033manufacture(0121-0848, 0121-1696)

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