Medication info

Citalopram 20mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injectionExpired
Ingredient · strength
Escitalopram Oxalate›25.54mg / 1 tablet
Manufacturer / importer
Seongwon Adcock Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201901802 · Approved 2019.03.26

This product's status changed to Expired on 2024.03.26. 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 (e.g., 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, regardless of meals. 1) Adults (1) 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 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, drug treatment for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an increase 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. (3) 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded was studied for 6 months; treatment to prevent relapse should be considered for each individual patient. The usefulness of long-term treatment should be reassessed regularly. (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 at least 1 week of treatment. A long-term study was conducted in which patients who responded to 12 weeks of open-label treatment received 20mg per day 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. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. A long-term study was conducted in patients who responded to 16 weeks of open-label treatment and received 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure symptom recovery. If this drug is administered long term, its usefulness and dosage should be regularly reassessed for each individual patient. 2) Patients with renal impairment No dosage adjustment is necessary for 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. Depending on the patient's response, the dose may be increased to 10mg per day. 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 psychiatric disorders and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 other interventions, including hospitalization, to treat a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available 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. Patients 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 methylene blue administered 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
Seongwon Adcock Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (e.g., 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 drug is used for the treatment of Major Depressive Disorder as well as Panic Disorder (with or without agoraphobia), 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, regardless of meals. 1) Adults (1) 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 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, drug treatment for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: The recommended initial dose is 5mg per day for 1 week, followed by an increase 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. (3) 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 condition with a chronic course, and continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded was studied for 6 months; treatment to prevent relapse should be considered for each individual patient. The usefulness of long-term treatment should be reassessed regularly. (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 at least 1 week of treatment. A long-term study was conducted in which patients who responded to 12 weeks of open-label treatment received 20mg per day 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. Depending on the patient's response, the dose may be increased to a maximum of 20mg per day. A long-term study was conducted in patients who responded to 16 weeks of open-label treatment and received 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure symptom recovery. If this drug is administered long term, its usefulness and dosage should be regularly reassessed for each individual patient. 2) Patients with renal impairment No dosage adjustment is necessary for 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. Depending on the patient's response, the dose may be increased to 10mg per day. 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 psychiatric disorders and starting treatment with this drug, an interval of at least 14 days must be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, 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 other interventions, including hospitalization, to treat a more urgent psychiatric condition, treatment should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this drug. If no alternative to linezolid or intravenous methylene blue is available 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. Patients 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 methylene blue administered 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 may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (ages 18-24) with major depressive disorder or other psychiatric conditions. Therefore, when administering to patients in this age group, the doctor must carefully evaluate the need and risks. Both patients and their families should closely monitor for abnormal behavioral changes such as worsening depressive symptoms, suicidal tendencies, and aggression during treatment with this drug. This drug should not be administered to patients with hypersensitivity to certain components or those taking MAO inhibitors. Additionally, patients with congenital long QT syndrome or those taking medications that can prolong the QT interval may be at risk when using this drug. Patients with closed-angle glaucoma or a history of glaucoma should be cautious as this drug may dilate the pupils and raise intraocular pressure. During the first 1-2 weeks of treatment, adverse reactions such as insomnia, dizziness, nausea, changes in appetite, and anxiety may occur, but they usually decrease with time. Rarely, serious side effects such as serotonin syndrome, cardiac arrhythmias, hyponatremia, and increased bleeding tendency may occur, so immediate consultation with a healthcare professional is necessary if such symptoms arise. Sudden discontinuation of this drug may lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so it should be tapered gradually under medical supervision. Furthermore, caution should be exercised when co-administering this drug with other serotonergic agents or drugs that prolong the QT interval, as the risks may increase. Pregnant or breastfeeding women should consult with a specialist before using this drug as it may affect the newborn. Older adults may be more sensitive to the drug than younger adults, so initial doses should be lower and administered carefully. Caution is necessary when driving or operating machinery, and it should be stored out of reach of children.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate antidiuretic hormone secretion, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, nervousness, panic attack, confusion, aggression, depersonalization, hallucinations, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, akathisia, mydriasis, visual impairments, tinnitus, tachycardia, bradycardia, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, nosebleed, nausea, diarrhea, constipation, vomiting, dry mouth, 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, asthma, shortness of breath, fractures, palpitations, hypertension, paralysis, extrapyramidal symptoms, migraines, chest pain, drowsiness, aggressive reactions, anorexia, visual hallucinations, frequent urination, sedation, tremor, dry mouth, heartburn, anxiety, insomnia, hallucinations, nausea, abdominal pain, drowsiness, sexual dysfunction, dizziness, decreased libido, weight gain, headache, frequent urination, dizziness, drowsiness, gastrointestinal disturbances, heartburn, sedation, dry mouth, decreased libido, decreased appetite, dry mouth, dyspepsia, sweating, frequent urination, sexual dysfunction, tremor, weight gain, abdominal discomfort, anxiety, insomnia, visual hallucinations, retrograde anxiety, epileptic seizures, mania, suicidal impulse, suicidal behavior, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disorders, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmias, hypotension

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

Storage

This drug should be stored in a tightly closed container that can block light, and it is safe to store it at room temperature between 1 degrees and 30 degrees. Proper storage can help maintain the effectiveness of the drug and prevent degradation.

Appearance and packaging

Appearance

White oval 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.