Medication info

Escitalopram Oxalate 20 mg (Escitalopram Oxalate)

Prescription medicationApproval withdrawn
Ingredient · strength
Escitalopram Oxalate›Strength being verified
Manufacturer / importer
Kwangdong Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201902324 · Approved 2019.04.16

This product's status changed to Approval withdrawn on 2023.07.10. 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 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 medicine 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. The dose may be increased to a maximum of 20mg per day depending on the patient's response. If the dose of this medicine is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to start working. 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: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase it 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 administration of this medicine for longer than 10 weeks in the treatment of panic disorder have not been systematically studied. The physician should periodically reevaluate 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 improvement in symptoms. 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 respond 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 reevaluated 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 at least 1 week of treatment. A long-term treatment study administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. The physician should regularly reevaluate the usefulness of long-term treatment with this medicine 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 treatment study administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is used long term, its usefulness and dose should be regularly reevaluated 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 medicine, 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 medicine, an interval of at least 14 days should be observed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventions, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 medicine may be stopped 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 comes first. Treatment with this medicine 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 intravenous administration of this medicine at 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
Kwangdong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, 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 to treat various mental health issues such as major depressive disorder, panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder. It is particularly effective for panic disorder, whether or not accompanied by agoraphobia. This drug helps alleviate anxiety symptoms and compulsive behaviors, reducing social anxiety. It is suitable for the treatment of complex anxiety disorders, enhancing the quality of life for patients. Overall, it is an effective treatment for promoting mental stability and improving symptoms.

Dosage and Administration

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This medicine 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. The dose may be increased to a maximum of 20mg per day depending on the patient's response. If the dose of this medicine is to be increased to 20mg, it should be increased at intervals of at least 1 week. In general, antidepressants take 2-4 weeks to start working. 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: It is recommended to administer an initial dose of 5mg per day for 1 week, then increase it 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 administration of this medicine for longer than 10 weeks in the treatment of panic disorder have not been systematically studied. The physician should periodically reevaluate 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 improvement in symptoms. 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 respond 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 reevaluated 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 at least 1 week of treatment. A long-term treatment study administering 20mg per day for at least 6 months was conducted in patients who responded to 12 weeks of open-label treatment. The physician should regularly reevaluate the usefulness of long-term treatment with this medicine 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 treatment study administering 10mg or 20mg per day for at least 24 weeks was conducted in patients who responded to 16 weeks of open-label treatment. Obsessive-compulsive disorder is a chronic condition, so treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is used long term, its usefulness and dose should be regularly reevaluated 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 medicine, 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 medicine, an interval of at least 14 days should be observed. Conversely, when starting an MAO inhibitor for the treatment of psychiatric disorders, at least 14 days must have elapsed after discontinuing this medicine. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medicine because of the increased risk of serotonin syndrome. In patients requiring treatment for a more urgent psychiatric condition, including hospitalization and other interventions, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine. 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 medicine may be stopped 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 comes first. Treatment with this medicine 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 intravenous administration of this medicine at 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 may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depression or other psychiatric disorders, so a physician must carefully assess the risks and benefits before administration. This medication should not be used with certain drugs, especially MAO inhibitors, pimozide, and drugs that prolong the QT interval, as serious side effects may occur. During the initial 1-2 weeks of treatment, various adverse reactions such as anxiety, insomnia, dizziness, and nausea may occur, but most symptoms diminish over time. This medication should be avoided or administered with careful monitoring in patients with seizure disorders or manic states, and caution is advised in diabetic patients as it may affect blood sugar control. During treatment, worsening of depressive symptoms, suicidal thoughts, and aggressive behavior may occur, and both patients and their families should closely monitor for these changes and consult a physician immediately. Abrupt discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances, so the dosage should be gradually reduced according to a physician's instructions. If pregnant or nursing, this medication may affect the fetus or newborn, so it is essential to consult a physician before use. Elderly patients should start with a lower initial dose and adjust carefully, and patients with heart disease may require regular ECG monitoring due to potential risk of cardiac arrhythmias. This medication may impair judgment when driving or operating machinery, so caution is advised. In cases of overdose, central nervous system symptoms, gastrointestinal disturbances, and heart irregularities may occur, necessitating immediate medical attention, as no specific antidote exists and appropriate treatment based on symptoms is needed.

Side effects

Thrombocytopenia, anaphylactic reaction, inappropriate secretion of antidiuretic hormone, 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 abnormalities, tremors, taste disturbance, sleep disorders, 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, nosebleed, nausea, diarrhea, constipation, vomiting, polydipsia, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory dysfunction, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, paralysis, extrapyramidal disorders, migraine, asthma, shortness of breath, fractures, hypertension, sedation, frequent urination, tremors, dry mouth, heartburn, insomnia, visual disturbances, dizziness, sensory abnormalities, sleep disorders, agitation, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, visual impairment, hypotension, hypokalemia, hypomagnesemia, withdrawal symptoms, suicidal tendencies, suicidal impulses, suicidal behavior, hostility, aggression, anger, unstable blood pressure, flushing, high fever, hysterical, hepatic myoclonus, paroxysmal attacks, choreoathetosis, seizures, changes in mental status, coma, agitation, hallucinations, delirium, coma, chest pain

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 tightly sealed container that blocks light. Additionally, it is crucial to store it at a temperature between 1°C and 30°C to maintain its effectiveness.

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.