Medication info

Escitalopram Oxalate 10 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Prescription medicationApproval withdrawn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Approval withdrawn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 201902323 · 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This product's status changed to Approval withdrawn on 2023.07.10.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, with or without food. Adults 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 increasing the dose of this medicine to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to begin. Even after symptoms have resolved, drug treatment for at least 6 months is needed to ensure a sustained therapeutic effect. Panic disorder with or without agoraphobia: The recommended starting 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 medicine 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. Generally, 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, and should be considered individually 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. Generalized anxiety disorder: The starting 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, 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 medicine 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, in which 10mg or 20mg per day was administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is administered long term, the benefit and dose should be regularly reassessed for each patient. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. Caution is required in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment A starting 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. Discontinuation When discontinuing this medicine, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. Switching from MAO inhibitors for the treatment of psychiatric disorders If treatment with an MAO inhibitor for the treatment of psychiatric disorders is discontinued and treatment with this medicine is started, an interval of at least 14 days should be allowed. Conversely, if treatment with an MAO inhibitor for the treatment of psychiatric disorders is to be started, at least 14 days must have elapsed since discontinuation of this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a 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 medicine. 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 medicine 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 medicine 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 medicine 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
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 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.

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, with or without food. Adults 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 increasing the dose of this medicine to 20mg, the dose should be increased at intervals of at least 1 week. In general, 2-4 weeks are needed for antidepressant effects to begin. Even after symptoms have resolved, drug treatment for at least 6 months is needed to ensure a sustained therapeutic effect. Panic disorder with or without agoraphobia: The recommended starting 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 medicine 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. Generally, 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, and should be considered individually 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. Generalized anxiety disorder: The starting 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, 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 medicine 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, in which 10mg or 20mg per day was administered for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition, and treatment should be continued for a sufficient period to ensure recovery from symptoms. When this medicine is administered long term, the benefit and dose should be regularly reassessed for each patient. Patients with renal impairment No dose adjustment is necessary in patients with mild or moderate renal impairment. Caution is required in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment A starting 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. Discontinuation When discontinuing this medicine, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. Switching from MAO inhibitors for the treatment of psychiatric disorders If treatment with an MAO inhibitor for the treatment of psychiatric disorders is discontinued and treatment with this medicine is started, an interval of at least 14 days should be allowed. Conversely, if treatment with an MAO inhibitor for the treatment of psychiatric disorders is to be started, at least 14 days must have elapsed since discontinuation of this medicine. Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start treatment with this medicine because of the increased risk of serotonin syndrome. For patients requiring more urgent treatment for a 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 medicine. 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 medicine 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 medicine 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 medicine 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 may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses. Special care is needed, particularly for patients aged 18 to 24, who should be closely monitored for suicidal tendencies or behavior changes during treatment. This medication should not be used in patients with known allergies to its components, those taking MAO inhibitors, patients on pimozide, or those with QT prolongation syndrome. Common adverse reactions such as insomnia, anxiety, dizziness, and nausea may occur during the initial 1-2 weeks of treatment but tend to decrease over time. Caution is required for patients with epilepsy as this medication may exacerbate seizures, and it should be discontinued immediately if manic symptoms appear. Patients with diabetes may require dosage adjustment due to possible impact on blood sugar control. Family members or caregivers should carefully monitor for signs of abnormal behaviors such as suicidal risk, aggression, and anxiety during treatment. Sudden discontinuation can lead to withdrawal symptoms such as dizziness, anxiety, and sleep disturbances; therefore, it should be reduced gradually according to a physician's guidelines. Since this medication can cause QT interval prolongation, patients with heart disease or who are taking related medications are advised to undergo ECG testing. This medication can interact with various drugs, so it is essential to consult healthcare professionals if taking other medications. During pregnancy or breastfeeding, careful consideration is needed as this medication may affect the fetus or newborn; breastfeeding should be avoided or stopped while on this medication. Elderly patients are advised to start at a lower dose, and caution is needed when driving or operating machinery. In cases of overdose, central nervous system, gastrointestinal, and cardiovascular symptoms may occur, requiring immediate emergency treatment. Store this medicine out of reach of children and do not transfer it to other containers.

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, hallucination, mania, suicidal ideation, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disturbances, sleep disturbances, fainting, serotonin syndrome, movement disorders, abnormal movements, 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, thirst, gastrointestinal bleeding, hepatitis, abnormal liver function tests, increased sweating, urticaria, hair loss, rash, itching, petechiae, angioedema, arthralgia, myalgia, rhabdomyolysis, urinary retention, ejaculatory disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, sexual dysfunction, palpitations, numbness, extrapyramidal disorder, migraine, asthma, shortness of breath, fracture, hypertension, sedation, pollakiuria, tremor, visual disturbances, chest pain, nausea, vomiting, diarrhea, dizziness, sleep disturbances, anxiety, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, hyperactivity, visual impairment, QT interval prolongation, polymorphic ventricular tachycardia, ventricular arrhythmia, persistent sexual dysfunction

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

Storage

This medication should be stored in a tightly sealed container that blocks light and kept at room temperature between 1 to 30 degrees Celsius. Storing it this way helps maintain its effectiveness and safety.

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.