Medication info
Lexacure Tablet 5 mg (Escitalopram Oxalate)

Lexacure Tablet 5 mg (Escitalopram Oxalate)

Prescription medicationTablet
Ingredient · strength
Escitalopram Oxalate›6.39mg / 1 tablet
Manufacturer / importer
Dong-A ST Co., Ltd.
Appearance
White egg-shaped film-coated tablet
Packaging
30 tablets/container
Approval status
Active

MFDS item code 200806977 · Notified 2008.06.25 · Insurance code 642505820

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 medication is administered once daily in the morning or evening, without regard to 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 increasing the dose of this medication to 20mg, the dose 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, at least 6 months of drug therapy is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day as the initial dose for 1 week, then increase the dose 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 medication 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 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 it is recommended that treatment be continued for 12 weeks to ensure the therapeutic effect. Long-term treatment in patients who responded was studied for 6 months; treatment 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 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 administration 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 periodically reassess the usefulness of long-term treatment with this medication 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 administration 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, so treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dosage should be regularly reassessed for each patient. 2) Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30mL/min). 3) Patients with hepatic impairment It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation When discontinuing this medication, 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 medication, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days should have elapsed after discontinuing this medication. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and, in a specific patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medication 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 medication 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 medication 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 such use.

Ingredients

Manufacturer
Dong-A ST 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 medicine is used to treat mental health issues including major depressive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder. It helps alleviate symptoms tailored to each condition and improves the patient's daily life.

Dosage and Administration

Adult dosage

Safety has not been established for doses exceeding 20mg per day. This medication is administered once daily in the morning or evening, without regard to 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 increasing the dose of this medication to 20mg, the dose 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, at least 6 months of drug therapy is required to ensure the therapeutic effect. (2) Panic disorder with or without agoraphobia: It is recommended to administer 5mg per day as the initial dose for 1 week, then increase the dose 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 medication 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 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 it is recommended that treatment be continued for 12 weeks to ensure the therapeutic effect. Long-term treatment in patients who responded was studied for 6 months; treatment 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 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 administration 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 periodically reassess the usefulness of long-term treatment with this medication 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 administration 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, so treatment should be continued for a sufficient period to ensure symptom recovery. If this medication is administered long term, its usefulness and dosage should be regularly reassessed for each patient. 2) Patients with renal impairment No dosage adjustment is necessary in patients with mild or moderate renal impairment. Caution should be exercised in patients with severe renal impairment (CLCR < 30mL/min). 3) Patients with hepatic impairment It is recommended to administer an initial dose of 5mg per day for the first 2 weeks. Depending on the patient's response, the dose may be increased to 10mg per day. 4) Discontinuation When discontinuing this medication, 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 medication, an interval of at least 14 days should be allowed. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days should have elapsed after discontinuing this medication. 6) Other MAO inhibitors, such as linezolid or methylene blue Patients receiving linezolid or intravenous methylene blue should not start this medication because of the increased risk of serotonin syndrome. For patients requiring other interventional procedures, including hospitalization, or treatment of a more urgent psychiatric condition, administration should be considered. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medication. If no alternative to linezolid or intravenous methylene blue is available and, in a specific patient, the benefits of treatment with linezolid or intravenous methylene blue are judged to outweigh the risk of serotonin syndrome, this medication 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 medication 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 medication 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 such use.

Precautions

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depression or other psychiatric disorders, so careful judgment by a physician is required when prescribing to patients in this age group. This medication may be dangerous when used with certain drugs, especially in patients taking MAO inhibitors or pimozide. Patients with closed-angle glaucoma or a history of glaucoma should use this drug cautiously as it may dilate the pupils and increase intraocular pressure. During the first 1-2 weeks after initiation of treatment, unusual reactions such as anxiety, insomnia, and dizziness may commonly occur, but these symptoms often decrease over time. This medication may cause adverse reactions in various areas such as blood, mental, nervous, cardiac, gastrointestinal, and skin, so immediately consult a healthcare professional if symptoms occur. Immediate attention is required in case of psychiatric symptoms such as thoughts or behaviors of suicide, aggression, and hallucinations. This medication may increase the risk of seizures, so patients with a history of seizures must consult a physician before taking it. Diabetic patients should frequently check blood glucose levels, as this drug may affect blood glucose control, and treatment adjustments may be necessary. Abruptly stopping this medication may cause withdrawal symptoms like dizziness, anxiety, and sleep disturbances; therefore, doses should be gradually reduced in accordance with a physician's instructions. This drug may prolong the QT interval associated with heart rate, and may require an ECG in patients with heart disease or those taking related medications. Pregnant or breastfeeding women should consult a healthcare provider before taking this medication as it may affect the fetus or newborn. Elderly patients may have different drug reactions than adults, thus starting with a lower initial dose and careful monitoring is essential. Caution is needed when driving or operating machinery as the patient's condition should be assessed after taking this drug. In case of an overdose, symptoms like dizziness, vomiting, and heart abnormalities may occur, so it is important to adhere to the prescribed dosage and immediately seek medical attention if any abnormalities are present. This drug is not recommended for use in children and adolescents as safety and efficacy have not been established.

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, hyperexcitability, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disturbance, sleep disorders, syncope, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmia, 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, dyspnea, fractures, palpitations, paralysis, extrapyramidal disorder, migraine, chest pain, insomnia, aggressive response, anorexia, hallucinations, drowsiness, anxiety, sedation, tremor, dry mouth, frequent urination, sexual dysfunction, weight gain, nausea, abdominal pain, drowsiness, sexual dysfunction, dizziness, decreased libido, weight gain, nausea, headache, dizziness, drowsiness, gastrointestinal disturbance, heartburn, dry mouth, decreased libido, decreased appetite, dry mouth, dyspepsia, sweating, frequent urination, sexual dysfunction, tremor, weight gain, abdominal discomfort, insomnia, visual hallucinations, frequent urination, retrograde anxiety, epileptic seizure, mania, changes in blood sugar control, suicidal impulse, suicidal behavior, abnormal behavior changes, anxiety, agitation, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, akathisia, hypomania, mania, hyponatremia, petechiae, purpura, postpartum hemorrhage, serotonin syndrome, dizziness, sleep disorders, anxiety, nausea, vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, prolonged QT interval, polymorphic ventricular tachycardia, ventricular arrhythmia, hypotension, arrhythmia, hypokalemia, hyponatremia

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

Storage

This medication should be stored in a tightly sealed container that can block light and air. It is important to maintain room temperature between 1°C and 30°C for proper storage to ensure the safety of the drug's effectiveness.

Appearance and packaging

Appearance

White egg-shaped film-coated tablet

Package unit

30 tablets/container

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.

Questions about this medicine

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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.