Medication info
Lexler Tablet 10mg (Escitalopram Oxalate)

Lexler Tablet 10mg (Escitalopram Oxalate)

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

MFDS item code 200802853 · Notified 2008.03.14 · Insurance code 640004880

Summary

Main use
Treatment of depressive disorders, 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, regardless of meals. 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, at least 6 months of drug treatment is needed to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to start with 5mg per day for 1 week and 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 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. 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, and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. 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 was conducted in patients who responded to 12 weeks of open-label treatment, in which they received 20mg per day for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this medication 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 they received 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should be continued for a sufficient period to ensure recovery from symptoms. If this medication is used long term, the usefulness and dose should be reassessed regularly for each patient. 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). 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. If treatment with this medication is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 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 elapse after discontinuing this medication. Treatment with this medication should not be started in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment 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, for a particular 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. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting 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 methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous doses of this medication 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
HK inno.N Co., Ltd.

Efficacy & effects

Treatment of depressive disorders, 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 in the treatment of major depressive disorder, panic disorder (including cases 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 medication is administered once daily in the morning or evening, regardless of meals. 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, at least 6 months of drug treatment is needed to ensure a therapeutic effect. Panic disorder with or without agoraphobia: It is recommended to start with 5mg per day for 1 week and 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 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. 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, and should be considered for each patient to prevent relapse. The usefulness of long-term treatment should be reassessed regularly. 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 was conducted in patients who responded to 12 weeks of open-label treatment, in which they received 20mg per day for at least 6 months. The physician should regularly reassess the usefulness of long-term treatment with this medication 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 they received 10mg or 20mg per day for at least 24 weeks. Obsessive-compulsive disorder is a chronic condition; treatment should be continued for a sufficient period to ensure recovery from symptoms. If this medication is used long term, the usefulness and dose should be reassessed regularly for each patient. 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). 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. If treatment with this medication is discontinued, the dose should be gradually reduced over at least 1-2 weeks to avoid the possibility of withdrawal symptoms. 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 elapse after discontinuing this medication. Treatment with this medication should not be started in patients receiving linezolid or intravenous methylene blue because of the increased risk of serotonin syndrome. For patients requiring treatment for a more urgent psychiatric condition, including hospitalization or other interventional procedures, treatment 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, for a particular 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. Patients should be monitored for symptoms of serotonin syndrome for 2 weeks after starting 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 methylene blue administered by non-intravenous routes (oral tablets or local injection) or with intravenous doses of this medication 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 to treat psychiatric disorders such as major depressive disorder. In children, adolescents, and young adults (ages 18-24), taking this medication may increase the risk of suicidal thoughts or behaviors, and physicians should exercise caution. For adults aged 25 and older, these risks are not increased, and for those aged 65 and older, the risk tends to decrease. If depressive symptoms worsen or if abnormal behaviors such as suicidal thoughts, aggression, or anger appear while taking this medication, medical consultation should be sought immediately. This drug should not be taken with certain medications, especially MAO inhibitors, as it may cause life-threatening serotonin syndrome and is an absolute contraindication. Additionally, patients taking pimozide or medications that prolong the QT interval should not use this drug. Patients with angle-closure glaucoma or a history of glaucoma should be cautious as this drug may dilate pupils and raise intraocular pressure. Initial treatment may commonly cause side effects such as anxiety, insomnia, dizziness, nausea, weight changes, and reduced libido, but symptoms often ease with time. In particular, this drug can cause abnormal heart rhythms, so caution is needed for patients with heart conditions, and an ECG may be recommended. When discontinuing this medication, the dosage should not be stopped abruptly, and it should be reduced gradually to avoid withdrawal symptoms such as dizziness, anxiety, and sleep disturbances. Pregnant or breastfeeding women should consult a physician before taking this medication as it may impact the fetus or newborn. Caution is also advised when driving or operating machinery as symptoms may warrant carefulness. The safety and efficacy of this drug in children and adolescents have not been adequately established, and it is best to avoid use in these populations. For elderly patients, it is preferable to start with a reduced dosage, and attention should be paid to potential drug interactions with other medications being taken.

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, hyperactivity, panic attack, confusion, aggression, depersonalization, hallucination, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, syncope, serotonin syndrome, movement disorders, motor dysfunction, seizures, psychomotor agitation, inability to sit still, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmia, orthostatic hypotension, sinusitis, yawning, epistaxis, 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, ejaculation disorder, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fracture, palpitations, hypertension, paralysis, extrapyramidal disorders, migraine, chest pain, tremors, dry mouth, urinary frequency, sedation, heartburn, anxiety, visual hallucinations, dry mouth, decreased appetite, decreased libido, hallucinations, drowsiness, aggressive reactions, sexual dysfunction, weight gain, dizziness, decreased libido, anorexia, hallucinations, cough, asthma, dyspnea, fracture, arthralgia, palpitations, hypertension, nausea, headache, dizziness, drowsiness, gastrointestinal disturbances, sweating, urinary frequency, sexual dysfunction, tremors, weight gain, abdominal discomfort, insomnia, visual hallucinations, inability to sit still, anxiety, restlessness, panic disorder, insomnia, excitement, hostility, aggression, impulsivity, hypomania, mania, 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 is sensitive to light and should be stored in a container that does not allow light to enter. It is also recommended to store it at room temperature between 1 degree and 30 degrees Celsius 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.