Medication info
Escitalopram (Escitalopram Oxalate)

Escitalopram (Escitalopram Oxalate)

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

MFDS item code 200810973 · Notified 2008.11.13 · Insurance code 671702330

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (such as panic disorder and social anxiety disorder), and obsessive-compulsive disorder
Who uses it
Adults
Adult dosage
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 dosage 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 required for the effects of antidepressants to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then 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 administration of this drug for longer 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 dosage is 10mg once daily. In general, 2-4 weeks are required 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 of responding patients has been studied for 6 months, and should be considered on an individual patient basis 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 therapy should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug therapy has not been compared with cognitive behavioral therapy. Drug therapy is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dosage 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 regularly reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage 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, and treatment should be continued for a sufficient period to ensure recovery of symptoms. When this drug is administered long term, the usefulness and dosage for each patient should be reassessed regularly. 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. 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, use 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 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 comes 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 non-intravenous routes (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
Genewon Science Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (such as 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 mental health issues such as major depressive disorder, panic disorder (with or without agoraphobia), social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

Dosage and Administration

Adult dosage

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 dosage 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 required for the effects of antidepressants to become apparent. Even after symptoms have resolved, drug therapy for at least 6 months is required to ensure a therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer an initial dose of 5mg per day for 1 week, then 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 administration of this drug for longer 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 dosage is 10mg once daily. In general, 2-4 weeks are required 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 of responding patients has been studied for 6 months, and should be considered on an individual patient basis 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 therapy should be given only when social anxiety disorder significantly interferes with occupational and social activities. Drug therapy has not been compared with cognitive behavioral therapy. Drug therapy is one part of an overall treatment strategy. (4) Generalized anxiety disorder: The initial dosage 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 regularly reassess the usefulness of long-term treatment with this drug for each patient. (5) Obsessive-compulsive disorder: The usual dosage 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, and treatment should be continued for a sufficient period to ensure recovery of symptoms. When this drug is administered long term, the usefulness and dosage for each patient should be reassessed regularly. 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. 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 for the treatment of psychiatric disorders When discontinuing an MAO inhibitor used for the treatment of psychiatric disorders and starting treatment with this drug, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor for the treatment of 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 treatment with this drug because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, use 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 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 comes 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 non-intravenous routes (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 an antidepressant used for the treatment of depression and other psychiatric disorders. This drug can increase the risk of suicidal thoughts or behavior, particularly in children, adolescents, and young adults aged 18 to 24, so when administering to patients in this age group, the physician should carefully assess the need for treatment and the risks involved. This drug should not be used in certain patients, such as those allergic to its ingredients, patients taking MAO inhibitors, patients with congenital QT prolongation or QT interval prolongation, and patients with genetic issues such as lactose intolerance. Patients with glaucoma or a history of glaucoma should be cautious as this drug may dilate the pupil and increase intraocular pressure. Various adverse reactions such as anxiety, insomnia, dizziness, nausea, weight changes may occur during treatment, especially at the beginning of therapy. At the start of antidepressant treatment, there may be worsening of depressive symptoms or increased risk of suicide, so patients and families should carefully monitor for changes in symptoms and consult a physician immediately if any concerning signs occur. This drug should not be stopped suddenly as withdrawal symptoms such as dizziness, anxiety, insomnia may appear; thus, the dosage should be gradually reduced under medical supervision. This drug may affect the heart and can lead to side effects such as QT interval prolongation, therefore, patients with heart diseases should consult a physician before taking it. This drug may interact with other medications, particularly MAO inhibitors, pimozide, drugs that prolong QT intervals, serotonin acting drugs, so caution is required when used in combination. Pregnant or breastfeeding women should consult a physician as this drug may affect the newborn; if breastfeeding, it is advised to avoid this medication or to stop breastfeeding. This drug is not recommended for children and adolescents as safety and efficacy have not been established. Elderly patients should start at a lower initial dose and have the maximum dose adjusted to a lower level. Patients should be cautious about driving or operating machinery while taking this medication, so they should monitor their condition well. In case of overdose, symptoms affecting the central nervous system, gastrointestinal symptoms, cardiac side effects may occur, and immediate medical attention should be sought.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, hyperprolactinemia, decreased appetite, increased appetite, weight gain, weight loss, hyponatremia, anorexia, anxiety, restlessness, abnormal dreams, decreased libido, sexual dysfunction, bruxism, agitation, irritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disturbance, sleep disorders, syncope, serotonin syndrome, extrapyramidal symptoms, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, extended QT interval in ECG, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, nosebleeds, 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, dizziness, paralysis, extrapyramidal disorder, migraine, chest pain, drowsiness, aggressive reactions, anorexia, hallucinations, polyuria, sedation, tremors, dry mouth, sweating, weight gain, anxiety, insomnia, visual hallucinations, retrograde anxiety, epilepsy seizures, mania, changes in blood sugar control, suicidal impulses, suicidal behavior, unusual behavioral changes, anxiety, agitation, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania, akathisia, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations

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

Storage

This medication should be stored in a tightly closed container that can block light, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents 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.