Medication info

Citalopram Tablet 5mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injectionExpired
Ingredient · strength
Escitalopram Oxalate›6.39mg / 1 tablet
Manufacturer / importer
Aprogen Biologics Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201903397 · Approved 2019.05.24

This product's status changed to Expired on 2024.05.24. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (including panic and social anxiety disorders), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
The safety of doses exceeding 20mg per day has not been established. This drug is administered once daily in the morning or evening, with or without food. Major depressive disorder: The usual dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. If the dose of this drug is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to become apparent. Even after symptoms have resolved, medication treatment for at least 6 months is needed to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase the dose to 10mg per day. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. The maximum effect appears after approximately 3 months. The safety and efficacy of long-term administration of this drug for more than 10 weeks in the treatment of panic disorder have not been systematically studied. The physician should periodically reassess each patient to determine the need for continued treatment. Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are needed for symptoms to improve. Thereafter, depending on the patient's response, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day. Social anxiety disorder is a chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded has been studied for 6 months and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be periodically reassessed. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. Generalized anxiety disorder: The initial dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day after at least 1 week of treatment. A long-term treatment study was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should periodically reassess the usefulness of long-term treatment with this drug for each patient. Obsessive-compulsive disorder: The usual dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. A long-term treatment study was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so this drug should be administered for a sufficient duration to ensure recovery from symptoms. If this drug is administered long term, its usefulness and dose should be periodically reassessed for each patient. No dose adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30㎖/min). It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. If treatment with this drug is discontinued, the dose should be reduced gradually over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this drug. Treatment with this drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Ingredients

Manufacturer
Aprogen Biologics Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (including panic and social anxiety disorders), and obsessive-compulsive disorder

  • Major depressive disorder
  • agoraphobia
  • panic disorder
  • social anxiety disorder
  • social phobia
  • generalized anxiety disorder
  • obsessive-compulsive disorder
View approved original text

This medication is used for the treatment of major depressive disorder, panic disorder (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

How it is given

Adult administration

The safety of doses exceeding 20mg per day has not been established. This drug is administered once daily in the morning or evening, with or without food. Major depressive disorder: The usual dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. If the dose of this drug is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to become apparent. Even after symptoms have resolved, medication treatment for at least 6 months is needed to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase the dose to 10mg per day. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. The maximum effect appears after approximately 3 months. The safety and efficacy of long-term administration of this drug for more than 10 weeks in the treatment of panic disorder have not been systematically studied. The physician should periodically reassess each patient to determine the need for continued treatment. Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are needed for symptoms to improve. Thereafter, depending on the patient's response, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day. Social anxiety disorder is a chronic condition, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded has been studied for 6 months and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be periodically reassessed. Social anxiety disorder is a well-defined diagnostic term for a specific disorder and should not be confused with excessive shyness. Drug treatment should be used only when social anxiety disorder significantly interferes with occupational and social activities. Drug treatment has not been compared with cognitive behavioral therapy. Drug treatment is one part of an overall treatment strategy. Generalized anxiety disorder: The initial dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day after at least 1 week of treatment. A long-term treatment study was conducted in patients who responded to 12 weeks of open-label treatment, administering 20mg per day for at least 6 months. The physician should periodically reassess the usefulness of long-term treatment with this drug for each patient. Obsessive-compulsive disorder: The usual dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. A long-term treatment study was conducted in patients who responded to 16 weeks of open-label treatment, administering 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so this drug should be administered for a sufficient duration to ensure recovery from symptoms. If this drug is administered long term, its usefulness and dose should be periodically reassessed for each patient. No dose adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30㎖/min). It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. If treatment with this drug is discontinued, the dose should be reduced gradually over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this drug. Treatment with this drug should not be initiated in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients who require treatment for a more urgent psychiatric condition, including hospitalization, other interventions should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If there is no alternative to linezolid or intravenous methylene blue and, for a particular patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this drug may be discontinued immediately and linezolid or intravenous methylene blue administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks after administration of linezolid or intravenous methylene blue, or until 24 hours after the last dose, whichever comes first. Treatment with this drug may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by non-intravenous routes (oral tablets or local injection) or intravenous administration of this drug at a dose of 1mg/kg or less is unclear. Nevertheless, clinicians should be aware of the possibility of emergency symptoms of serotonin syndrome with these uses.

Precautions

This medication is an antidepressant mainly used to treat symptoms associated with depression. It may increase the risk of suicidal thoughts or behaviors, especially in children, adolescents, and young adults aged 18 to 24, so physicians should carefully evaluate its use. Patients with an allergy to any component of this medication or those taking certain medications (MAO inhibitors, pimozide, etc.) should not take this medication. Patients with glaucoma or a history of glaucoma should take caution as this medication may dilate pupils and increase intraocular pressure. During the first 1-2 weeks of treatment, various side effects such as anxiety, insomnia, dizziness, and nausea may occur, but these symptoms often subside over time. This medication can lower sodium levels in the blood, so caution is needed for the elderly or those with certain conditions. When taken with other medications, a serious side effect known as serotonin syndrome may occur, so it should especially not be combined with MAO inhibitors or certain psychiatric medications. Abruptly stopping this medication can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to a doctor's instructions. Pregnant or breastfeeding women should consult a doctor as it may affect the newborn. The elderly should start at lower doses than general adults for safety. There may be a need for caution when driving or operating machinery, but generally, it does not significantly affect mental functions. In case of overdose, symptoms of central nervous system effects or heart arrhythmias may appear, so immediate medical attention is required. The safety and efficacy of this medication have not been established in children and adolescents, so it is recommended not to use it in this population. When storing the medication, keep it out of reach of children and do not transfer it to other containers.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, paresthesia, tremor, taste disorder, sleep disturbances, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, dry mouth, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, alopecia, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, respiratory distress, fracture, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, tremors, dry mouth, frequent urination, anxiety, insomnia, visual disturbances, retrograde anxiety, epileptic seizures, mania, changes in blood sugar control, anxiety, agitation, panic disorder, insomnia, excitement, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disturbances, anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhea, headache, frequent urination, dizziness, drowsiness, heartburn, sedation, dry mouth, decreased appetite, sweating, frequent urination, sexual dysfunction, tremors, weight gain, abdominal discomfort, hallucinations, sexual dysfunction, withdrawal symptoms, dizziness, sleep disturbances, anxiety, nausea, vomiting, tremor, confusion, sweating, headache, diarrhea, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a light-resistant container. Additionally, it is important to store it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.