Medication info
Citalopram 10 mg Tablets (Escitalopram Oxalate)

Citalopram 10 mg Tablets (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›12.77mg / 1 tablet
Manufacturer / importer
Guju Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201906124 · Approved 2019.08.28 · Insurance code 669805540

Summary

Main use
Treatment of major depressive disorder and anxiety disorders (including panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, with or without food. 1) Adults (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. If the dose of this drug is to be increased to 20mg, the increase should be made 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, drug treatment for at least 6 months is needed to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, then increase the dose to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on the patient's response. 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. (3) Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on the patient's response. Social anxiety disorder is a condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded was studied for 6 months, and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. 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 given 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. (4) 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 administration for at least 1 week. A long-term administration study was conducted in patients who responded to 12 weeks of open-label treatment, in which 20mg per day was administered for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. A long-term administration study was conducted in patients who responded to 16 weeks of open-label treatment, in which 10mg or 20mg per day was administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; this drug should be administered for a sufficient period to ensure symptom recovery. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment 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). 3) Patients with hepatic impairment An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day depending on the patient's response. 4) Discontinuation of treatment When discontinuing this drug, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 5) Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with 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
Guju Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder and anxiety disorders (including panic disorder and social anxiety disorder), 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 various psychiatric disorders including major depressive disorder, panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

How it is given

Adult administration

Safety has not been established for doses exceeding 20mg per day. This drug is administered once daily in the morning or evening, with or without food. 1) Adults (1) Major depressive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. If the dose of this drug is to be increased to 20mg, the increase should be made 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, drug treatment for at least 6 months is needed to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day for 1 week as the initial dose, then increase the dose to 10mg per day. The dose may be increased to a maximum of 20mg per day depending on the patient's response. 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. (3) Social anxiety disorder: The usual dose is 10mg once daily. In general, 2-4 weeks are needed for symptoms to improve. Thereafter, the dose may be reduced to 5mg per day or increased to a maximum of 20mg per day, depending on the patient's response. Social anxiety disorder is a condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment of patients who responded was studied for 6 months, and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. 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 given 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. (4) 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 administration for at least 1 week. A long-term administration study was conducted in patients who responded to 12 weeks of open-label treatment, in which 20mg per day was administered for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dose is 10mg once daily. The dose may be increased to a maximum of 20mg per day depending on the patient's response. A long-term administration study was conducted in patients who responded to 16 weeks of open-label treatment, in which 10mg or 20mg per day was administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; this drug should be administered for a sufficient period to ensure symptom recovery. When this drug is administered long term, its usefulness and dosage should be reassessed regularly for each patient. 2) Patients with renal impairment 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). 3) Patients with hepatic impairment An initial dose of 5mg per day for the first 2 weeks is recommended. The dose may be increased to 10mg per day depending on the patient's response. 4) Discontinuation of treatment When discontinuing this drug, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 5) Switching from MAO inhibitors used to treat psychiatric disorders When discontinuing an MAO inhibitor used to treat a psychiatric disorder and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat a psychiatric disorder, at least 14 days must have elapsed after discontinuing this drug. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventional procedures, administration 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 the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome in a particular patient, 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 occurs first. Treatment with this drug may be restarted 24 hours after the last dose of linezolid or intravenous methylene blue. The risk associated with administration of methylene blue by a non-intravenous route (oral tablets or local injection), or with 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 drug is primarily an antidepressant used to treat psychiatric disorders such as depression. During the course of treatment with this drug, it is important to closely monitor young adults and adolescents aged 18 to 24, as they may experience an increased risk of suicidal thoughts or behaviors. This medication should not be taken with certain drugs, especially Monoamine Oxidase Inhibitors (MAOIs), as it can be very dangerous to take an MAOI in combination or within 14 days after stopping an MAOI. Patients with hypersensitivity to this drug, certain heart diseases, a prolonged QT interval, or specific genetic disorders should not take this medication. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this drug may dilate the pupils and increase intraocular pressure. During the first 1-2 weeks of treatment, various side effects such as anxiety, insomnia, dizziness, and gastrointestinal disturbances may occur, but these often improve with time. Notably, this medication can cause serious side effects, including irregular heartbeat, tendency to bleed, hyponatremia, and serotonin syndrome; if any abnormal symptoms occur, immediate consultation with a healthcare professional is required. Sudden discontinuation of this medication may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be tapered off under the guidance of a physician. Pregnant or breastfeeding women should consult a doctor before taking this medication, as it may affect the fetus or newborn. Elderly patients should start with a lower dosage than the general adult population, and caution is advised when driving or operating machinery. In case of overdose, there is no specific antidote, so appropriate medical treatment should be sought immediately, and heart condition should be closely monitored. The safety and efficacy of this medication have not been established in children and adolescents, so it is not recommended for this age group.

Side effects

Thrombocytopenia, anaphylactic reactions, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, loss of appetite, anxiety, agitation, abnormal dreams, decreased libido, sexual dysfunction, bruxism, restlessness, hypersensitivity, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disturbances, syncope, serotonin syndrome, dyskinesia, movement disorders, convulsions, psychomotor agitation, akathisia, mydriasis, visual disturbances, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, epistaxis, nausea, diarrhea, constipation, vomiting, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculation disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, xerostomia, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorders, migraine, asthma, respiratory distress, fractures, hypertension, chest pain, drowsiness, aggressive reactions, loss of appetite, hallucinations, cough, asthma, respiratory distress, chest pain, fever, fractures, arthralgia, sexual dysfunction, palpitations, hypertension, dizziness, sensory disturbances, paralysis, extrapyramidal disorders, migraine, drowsiness, insomnia, aggressive reactions, decreased libido, loss of appetite, hallucinations, cough, asthma, respiratory distress, weight gain, chest pain, fever, fractures, arthralgia, sexual dysfunction, palpitations, hypertension, nausea, headache, constipation, dizziness, xerostomia, abdominal pain, insomnia, weight gain, fever, vomiting, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, diarrhea, paralysis, extrapyramidal disorders, migraine, decreased libido, loss of appetite, hallucinations, asthma, respiratory distress, fractures, arthralgia, hypertension, nausea, headache, dizziness, drowsiness, gastrointestinal disturbances, heartburn, sedation, thirst, decreased libido, decreased appetite, dry mouth, dyspepsia, sweating, polyuria, sexual dysfunction, tremors, weight gain, abdominal discomfort, anxiety, insomnia, visual disturbances, headache, polyuria, dizziness, sensory disturbances, sleep disturbances, restlessness, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual disturbances, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, hypokalemia, hyponatremia, dizziness, sleep disturbances, anxiety, withdrawal symptoms

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 container that does not allow light to enter. Also, it is recommended to keep the medication at room temperature between 1°C to 30°C. It is safe to avoid excessively hot or cold places.

Appearance and packaging

Appearance

White oval film-coated tablets

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.