Medication info
Lexastat Tablet 5 mg (Escitalopram Oxalate)

Lexastat Tablet 5 mg (Escitalopram Oxalate)

Prescription medicationTabletIntravenous injection
Ingredient · strength
Escitalopram Oxalate›6.39mg / 1 tablet
Manufacturer / importer
Daiung Bio Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802265 · Approved 2018.05.30 · Insurance code 694001740

Summary

Main use
Treatment of major depressive disorder, anxiety disorders (panic disorder, social anxiety disorder, etc.), and obsessive-compulsive disorder
Who receives it
Adults
Adult administration
The safety of doses exceeding 20mg daily has not been established. Administer this medicine 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 daily. If increasing the dose to 20mg, increase it at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to develop. Even after symptoms resolve, at least 6 months of drug treatment is required to ensure a therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg daily for 1 week, followed by an increase to 10mg daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily. The maximum effect occurs 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. Social anxiety disorder: The usual dose is 10mg once daily. Generally, 2-4 weeks are required for improvement in symptoms. Thereafter, depending on the patient's response, the dose may be reduced to 5mg daily or increased to a maximum of 20mg daily. Continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded has been studied for 6 months. Generalized anxiety disorder: The recommended initial dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily after at least 1 week of treatment. A long-term study administered 20mg daily for at least 6 months to patients who responded to 12 weeks of open-label treatment. 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 daily. A long-term study administered 10mg or 20mg daily for at least 24 weeks to patients who responded to 16 weeks of open-label treatment. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment: An initial dose of 5mg daily for the first 2 weeks is recommended. Depending on the patient's response, the dose may be increased to 10mg daily. 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 used to treat psychiatric disorders: When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start this medicine. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine; discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 2 weeks after administration of linezolid or intravenous methylene blue or 24 hours after the last dose, whichever comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear.

Ingredients

Manufacturer
Daiung Bio Co., Ltd.

Efficacy & effects

Treatment of major depressive disorder, anxiety disorders (panic disorder, social anxiety disorder, etc.), 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 various anxiety and depression-related disorders such as major depressive disorder, panic disorder, social anxiety disorder (social phobia), generalized anxiety disorder, and obsessive-compulsive disorder.

How it is given

Adult administration

The safety of doses exceeding 20mg daily has not been established. Administer this medicine 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 daily. If increasing the dose to 20mg, increase it at intervals of at least 1 week. In general, 2-4 weeks are required for antidepressant effects to develop. Even after symptoms resolve, at least 6 months of drug treatment is required to ensure a therapeutic effect. Panic disorder with or without agoraphobia: The recommended initial dose is 5mg daily for 1 week, followed by an increase to 10mg daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily. The maximum effect occurs 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. Social anxiety disorder: The usual dose is 10mg once daily. Generally, 2-4 weeks are required for improvement in symptoms. Thereafter, depending on the patient's response, the dose may be reduced to 5mg daily or increased to a maximum of 20mg daily. Continued treatment for 12 weeks is recommended to ensure a therapeutic effect. Long-term treatment in patients who responded has been studied for 6 months. Generalized anxiety disorder: The recommended initial dose is 10mg once daily. Depending on the patient's response, the dose may be increased to a maximum of 20mg daily after at least 1 week of treatment. A long-term study administered 20mg daily for at least 6 months to patients who responded to 12 weeks of open-label treatment. 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 daily. A long-term study administered 10mg or 20mg daily for at least 24 weeks to patients who responded to 16 weeks of open-label treatment. Patients with renal impairment: No dose adjustment is necessary in patients with mild or moderate renal impairment. Use with caution in patients with severe renal impairment (CLCR < 30㎖/min). Patients with hepatic impairment: An initial dose of 5mg daily for the first 2 weeks is recommended. Depending on the patient's response, the dose may be increased to 10mg daily. 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 used to treat psychiatric disorders: When discontinuing an MAO inhibitor used to treat psychiatric disorders and starting treatment with this medicine, allow an interval of at least 14 days. Conversely, when starting an MAO inhibitor to treat psychiatric disorders, at least 14 days must have elapsed since discontinuing this medicine. Other MAO inhibitors, such as linezolid or methylene blue: Patients receiving linezolid or intravenous methylene blue should not start this medicine. It may be necessary to urgently administer linezolid or intravenous methylene blue to a patient already receiving this medicine; discontinue this medicine immediately and administer linezolid or intravenous methylene blue. Monitor the patient for symptoms of serotonin syndrome until 2 weeks after administration of linezolid or intravenous methylene blue or 24 hours after the last dose, whichever comes first. Treatment with this medicine may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue. The risks associated with administration of methylene blue by a nonintravenous route (oral tablets or local injection) or intravenous administration of this medicine at doses of 1mg/kg or less are unclear.

Precautions

This medication is used to treat depression and other psychiatric disorders, and special caution is needed as there may be an increased risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults. Patients taking this medication should be closely monitored for any abnormal behavioral changes such as suicidal thoughts or actions, aggression, rage, etc., and family members or caregivers should also carefully observe the patient. Patients with allergies to the active substance or other components of this medication, patients taking MAO inhibitors, and patients with certain heart diseases or prolonged QT intervals should not use this product. Patients with a history of angle-closure glaucoma or glaucoma should use this medication cautiously as it may cause pupil dilation and increase intraocular pressure. Common side effects such as insomnia, dizziness, nausea, and headaches may appear during the first 1-2 weeks and often improve over time. This medication may cause mental symptoms such as anxiety, agitation, panic attacks, confusion, and hallucinations; therefore, if there are any changes in symptoms, the doctor should be consulted immediately. Upon discontinuation, withdrawal symptoms such as dizziness, anxiety, and sleep disturbances may occur, so the dosage should be reduced gradually according to the physician's instructions. This medication can affect heart rate, so patients with heart disease may need an ECG before administration. As it may interact with other medications, especially MAO inhibitors, certain antipsychotics, anticoagulants, and blood pressure medications, patients should inform their physician if they are taking these. Pregnant or breastfeeding women should consult with their doctor before taking this medication, as it may affect the newborn. Elderly patients should start with a lower dose and use it cautiously, paying attention when driving or operating machinery. Overdose can lead to serious side effects, so the prescribed dose must be strictly followed and stored out of reach of children.

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, hyperirritability, panic attacks, confusion, aggression, depersonalization, hallucinations, mania, suicidal thoughts, suicidal behavior, insomnia, drowsiness, dizziness, perceptual disturbances, tremors, taste disorders, sleep disorders, fainting, serotonin syndrome, dyskinesia, movement disorders, seizures, psychomotor agitation, akathisia, mydriasis, visual impairment, tinnitus, tachycardia, bradycardia, QT prolongation on ECG, polymorphic ventricular tachycardia, ventricular arrhythmias, orthostatic hypotension, sinusitis, yawning, nosebleeds, 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 disorders, erectile dysfunction, uterine bleeding, menorrhagia, galactorrhea, postpartum hemorrhage, priapism, fatigue, fever, edema, headache, dry mouth, abdominal pain, dyspepsia, enteritis, sensory disturbances, cough, asthma, dyspnea, fractures, palpitations, hypertension, paralysis, extrapyramidal disorder, migraine, chest pain, sleepiness, aggressive reactions, anorexia, visual hallucinations, sedation, frequent urination, tremor, dry mouth, heartburn, anxiety, insomnia

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 it is important to maintain a storage temperature between 1 and 30 degrees Celsius. Storing it this way helps preserve the medication's efficacy.

Appearance and packaging

Appearance

White round 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.

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.